THE ARTICLES OF THE MACHINERY DIRECTIVE
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Article 1 Scope
1. This Directive applies to the following products:
- machinery;
- interchangeable equipment;
- safety components;
- lifting accessories;
- chains, ropes and webbing;
- removable mechanical transmission devices; (g) partly completed machinery.
2. The following are excluded from the scope of this Directive:
- safety components intended to be used as spare parts to replace identical components and supplied by the manufacturer of the original machinery;
- specific equipment for use in fairgrounds and/or amusement parks;
- machinery specially designed or put into service for nuclear purposes which, in the event of failure, may result in an emission of radioactivity;
- weapons, including firearms;
- the following means of transport:
— agricultural and forestry tractors for the risks covered by Directive 2003/37/EC, with the exclusion of machinery mounted on these vehicles,
— motor vehicles and their trailers covered by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (1), with the exclusion of machinery mounted on these vehicles,
— vehicles covered by Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two or three-wheel motor vehicles (2), with the exclusion of machinery mounted on these vehicles,
— motor vehicles exclusively intended for competition, and
— means of transport by air, on water and on rail networks with the exclusion of machinery mounted on these means of transport;
- seagoing vessels and mobile offshore units and machinery installed on board such vessels and/or units;
- machinery specially designed and constructed for military or police purposes;
- machinery specially designed and constructed for research purposes for temporary use
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in laboratories;
- mine winding gear;
- machinery intended to move performers during artistic performances;
- electrical and electronic products falling within the following areas, insofar as they are covered by Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits (3):
— household appliances intended for domestic use,
— audio and video equipment,
— information technology equipment,
— ordinary office machinery,
— low-voltage switchgear and control gear,
— electric motors;
- the following types of high-voltage electrical equipment: — switch gear and control gear, — transformers.
(1) OJ L 42, 23.2.1970, p. 1 Directive as last amended by Commission Directive 2006/28/EC (OJ L 65,
7.3.2006, p. 27).
(2) OJ L 124, 9.5.2002, p. 1. Directive as last amended by Commission Directive 2005/30/EC (OJ L 106, 27.4.2005, p. 17).
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Article 2 Definitions
For the purposes of this Directive, ‘machinery’ designates the products listed in Article 1(1 )(a) to (f).
The following definitions shall apply:
(a) ‘machinery’ means:
- an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application,
- an assembly referred to in the first indent, missing only the components to connect it on site or to sources of energy and motion,
- an assembly referred to in the first and second indents, ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or a structure,
- assemblies of machinery referred to in the first, second and third indents or partly completed machinery referred to in point (g) which, in order to achieve the same
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end, are arranged and controlled so that they function as an integral whole,
an assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power source is directly applied human effort;
- ‘interchangeable equipment’ means a device which, after the putting into service of machinery or of a tractor, is assembled with that machinery or tractor by the operator himself in order to change its function or attribute a new function, in so far as this equipment is not a tool;
- ‘safety component’ means a component:
- which serves to fulfil a safety function,
- which is independently placed on the market,
- the failure and/or malfunction of which endangers the safety of persons, and
- which is not necessary in order for the machinery to function, or for which normal components may be substituted in order for the machinery to function.
An indicative list of safety components is set out in Annex V, which may be updated in accordance with Article 8 (1) (a);
- ‘lifting accessory’ means a component or equipment not attached to the lifting machinery, allowing the load to be held, which is placed between the machinery and the load or on the load itself, or which is intended to constitute an integral part of the load and which is independently placed on the market; slings and their components are also regarded as lifting accessories;
- ‘chains, ropes and webbing’ means chains, ropes and webbing designed and
constructed for lifting purposes as part of lifting machinery or lifting accessories;
- ‘removable mechanical transmission device’ means a removable component for transmitting power between self-propelled machinery or a tractor and another machine by joining them at the first fixed bearing. When it is placed on the market with the guard it shall be regarded as one product;
- ‘partly completed machinery’ means an assembly which is almost machinery but which cannot in itself perform a specific application. A drive system is partly completed machinery. Partly completed machinery is only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment, thereby forming machinery to which this Directive applies;
. . .
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§32 The products covered by the Machinery Directive
Article 1 (1) sets out the scope of the Directive, that is to say the products to which the provisions of the Directive are applicable. Each of the seven categories listed in Article 1 (1), (a) to (g) is subject to a definition given in Article 2, (a) to (g). Consequently, Article 1 must be read together with Article 2. In the following comments, each of the seven categories of product subject to the Machinery Directive is examined in turn, together with its definition.
Article 2 Definitions
For the purposes of this Directive, ‘machinery’ designates the products listed in Article 1(1)(a) to (f).
. . .
§33 The use of the term ‘machinery’ in the broad sense
The first product category referred to in Article 1 (1) (a) and defined in Article 2 (a) is machinery. In Article 1 (1) (a) and Article 2 (a) the term ‘machinery’ is used in the strict sense. However, the definitions of the product categories set out in Article 2 are preceded by a sentence explaining that the term ‘machinery’ is also to be understood in a broad sense to refer to the six product categories referred to in Article 1 (1), (a) to (f).
The obligations set out in the articles of the Directive that apply to machinery shall thus be understood as applying both to machinery in the strict sense referred to in Article 1(1) (a) and also to the products referred to in Article 1(1) (b) to (f): interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing and removable mechanical transmission devices.
This is the case, for example, for the obligations set out in Article 4 (1) on market surveillance, Article 5 (1) relating to placing on the market and putting into service, Article 6 (1) on freedom of movement, Article 7 (1) and (2) on presumption of conformity and harmonised standards, Article 9 on specific measures to deal with potentially hazardous machinery, Article 11 on the safeguard clause, Article 12 on the procedures for assessing the conformity of machinery, Article 15 on installation and use of machinery, Article 16 on CE marking, Article 17 on non-conformity of marking and Article 20 on legal remedies. The obligations set out in these Articles do not apply to partly completed machinery referred to in Article 1 (1) (g).
Where obligations apply to partly completed machinery, this is explicitly stated, for example, in Article 4 (2) on market surveillance, Article 5 (2) relating to placing on the market, Article 6 (2) on freedom of movement and Article 13 on the procedure for partly completed machinery.
Where obligations apply both to machinery in the broad sense and also to partly completed machinery, this is also explicitly stated, for example, in Article 4 (3) on market surveillance and Article 6 (3) on freedom of movement.
In the essential health and safety requirements of Annex I to the Machinery Directive, the term ‘machinery’ is generally to be understood in the broad sense to designate any of the product categories referred to in Article 1 (1), (a) to (f). Where certain essential health and safety requirements are applicable to only one or more of these categories, this is explicitly stated or can be inferred from the context. For example, in part 4 of Annex I, certain requirements explicitly apply only to lifting accessories.
§34 Machinery in the strict sense
The product category referred to in Article 1 (1) (a), that is to say machinery in the strict sense, is defined in Article 2 (a). The definition includes five indents. In the following comments, the different elements of each indent of the definition are examined in turn.
Article 2 (a) – first indent
‘machinery’ means:
an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application,
. . .
§35 The basic definition
The first indent of the definition of 'machinery' includes the following elements:
. . . an assembly . . . consisting of linked parts or components . . .
Products with parts or components that are not linked together in an assembly are not considered as machinery.
This does not preclude the supply of machinery with certain parts disassembled for storage or transport purposes. In such cases, the machinery must be designed and constructed in order to prevent errors of fitting when the separate parts are assembled. This is particularly important if the machinery is intended for untrained non-professional users. The manufacturer must also provide adequate assembly instructions, taking account, where appropriate, of the level of general education and acumen that can reasonably be expected from non-professional users – see §225: comments on section 1.5.4, §259: comments on section 1.7.4.1 (d), and §264: comments on section 1.7.4.2 (i) of Annex I.
. . . at least one of which moves . . .
Products without moving parts are not considered as machinery.
. . . fitted with or intended to be fitted with a drive system . . .
The moving parts of machinery are powered by a drive system using one or more sources of energy such as thermal, electric, pneumatic, hydraulic or mechanical energy. The machinery may have a motor using its own source of energy such as thermal energy or energy provided by a battery. It may be connected to one or more external sources of energy such as a supply of electricity or compressed air. Machinery may use mechanical energy supplied by other equipment such as, for example, towed agricultural machinery that is driven by the power take-off of a tractor, or test beds for motor vehicles that are driven by the vehicles being tested; machinery may also be powered by natural sources of energy such as wind or water power.
Usually the manufacturer of complete machinery supplies the machinery fitted with its drive system. However, machines intended to be fitted with a drive system but supplied without it may also be considered as machinery. This provision takes account, for example, of the fact that certain users of machinery prefer to have a homogeneous stock of motors for their machines in order to facilitate maintenance.
For machinery to be supplied without a drive system:
- the manufacturer's risk assessment must take into account all the risks associated with the machinery, including those relating to the drive system to be fitted to the machinery – see §158: comments on General Principle 1 of Annex I;
- the machinery manufacturer must set out in his instructions all the necessary specifications for the drive system to be fitted such as the type, power and means of connection, and provide precise fitting instructions for the drive system – see §264: comments on section 1.7.4.2 (i) of Annex I;
- the conformity assessment of the machinery must cover the specifications of the drive system to be fitted and the fitting instructions;
- the CE-marking on the machinery and the EC Declaration of Conformity that accompanies the machinery must cover the specifications and instructions relating to the drive system to be fitted.
If the above conditions are not fulfilled, machinery without a fully specified drive system must be considered as partly completed machinery (PCM) – see §46: comments on Article 2 (g). In that case, the combination of such partly completed machinery and the drive system must be considered as the final machinery and must be subject to a specific conformity assessment – see §38: comments on the fourth indent of Article 1
(a).
. . . other than directly applied human or animal effort . . .
The moving parts of machinery subject to the Machinery Directive must be driven by a source of energy other than directly applied human or animal effort. Machinery driven by directly applied human or animal effort, such as, for example, hand-driven lawn mowers, hand drills or hand-pushed trolleys, which cease to operate as soon as the manual effort is no longer applied, are not subject to the Machinery Directive. Lifting machinery is the only exception to this general rule – see §40: comments on the fifth indent of Article 2
(a).
On the other hand, the Machinery Directive is applicable to machinery driven by manual effort which is not applied directly but stored, for example, in springs or in hydraulic or pneumatic accumulators, so that the machinery can function after the manual effort has ceased.
. . . which are joined together for a specific application . . .
Machinery must be useable for a specific application as applying to the complete machine and its intended use. Typical machinery specific applications include, for example, the processing, treatment, or packaging of materials, or the moving of materials, objects or persons.
Article 2 (a) - second indent
. . .
‘machinery’ means:
. . .
- an assembly referred to in the first indent, missing only the components to connect it on site or to sources of energy and motion,
. . .
§36 Machinery supplied without connection components
The second indent of the definition of machinery recognises that the characteristics of the components needed to connect a machine on site to the sources of energy and motion may depend on the site where the machinery is to be used or installed. Machinery may therefore be supplied without these components. In that case, the machinery manufacturer must set out in his instructions all the necessary specifications for the safe means of connection – see §264: comments on section 1.7.4.2 (i) of Annex I.
Article 2 (a) – third indent
. . .
‘machinery’ means:
. . .
— an assembly referred to in the first and second indents, ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or a structure,
. . .
§37 Machinery to be installed on a specific support
The third indent of the definition of machinery refers to machinery intended for installation on a means of transport or in a building or a structure.
Means of transport are, in general, excluded from the scope of the Machinery Directive, but machinery mounted on means of transport are subject to the Machinery Directive – see §54: comments on Article 1 (2) (e). Examples of machinery mounted on means of transport include, for example, loader cranes, tail lifts, tipper bodies, vehicle or trailermounted compressors, vehicle-mounted compaction systems, vehicle-mounted concrete mixers, skip loaders, powered winches, tippers, telescopic lifting arms and vehiclemounted mobile elevating work platforms.
Where such machinery is mounted on road vehicles, road trailers or tractors that are excluded from the scope of the Machinery Directive, the requirements of the Machinery Directive do not apply to the road vehicle, road trailer or tractor itself. However, the requirements of the Machinery Directive apply both to the mounted machinery and to all aspects of the interface between the machinery and the chassis on which it is mounted which may affect the safe travel and operation of the machinery. Machinery mounted on means of transport is therefore distinguished from self-propelled mobile machinery such as, for example, self-propelled construction machinery or self-propelled agricultural machinery, which is subject to the Machinery Directive in its entirety.
The third indent of the definition of machinery implies that the manufacturer of machinery intended to be installed on a means of transport or installed in a building or a structure is responsible for the conformity of the machinery with the relevant essential health and safety requirements. He must affix the CE-marking on the machinery and draw up and sign the EC Declaration of Conformity. The manufacturer of such machinery must take into account in his risk assessment all the risks associated with the machine, including those relating to installation of the machinery on the chassis of a vehicle or trailer or on a supporting structure – see §158: comments on General Principle 1 of Annex I. The machinery manufacturer shall set out in his instructions the necessary specifications for the supporting structure and provide precise installation instructions – see §264: comments on section 1.7.4.2 (i) of Annex I.
Manufacturers of machinery intended to be installed on means of transport must therefore specify the vehicles or trailers on which the machinery can be safely installed, either by reference to their technical characteristics or, where necessary, by reference to specific models of vehicle.
If a product intended to be installed on a means of transport is not supplied ready to install, for example, if important elements such as the supporting frame or stabilisers are missing, it should rather be considered as partly completed machinery – see §46: comments on Article 2 (g). In that case, the person who assembles the partly completed machinery and the other elements on the means of transport is to be considered as the manufacturer of the final machinery.
Manufacturers of machinery intended to be installed in a building or structure such as, for example, gantry cranes, certain lifts or escalators must specify the characteristics, in particular the load-bearing characteristics, of the structure needed to support the machinery. However, the machinery manufacturer is not responsible for the construction of the building or structure itself – see §262: comments on section 1.7.4.2 (i), and §361: comments on 4.4.2 (a) of Annex I.
The person who installs such a machine on a means of transport or in a building or structure is responsible for carrying out the machinery manufacturers’ installation instructions.
The conformity assessment of machinery intended to be installed on a means of transport or in a building or structure covers the machinery itself, the specifications for the supporting structure and the installation instructions. The necessary tests and inspections must be carried out on the machinery installed on its support in order to check the conformity with the essential health and safety requirements. The CE-marking on the machine and the EC Declaration of Conformity that must accompany the machine cover the conformity of the machine itself and the specifications and instructions relating to its installation.
In the case of machinery intended for lifting operations, the manufacturer is responsible for checking the fitness for purpose of the machinery ready to be put into service – see §350 to §352: comments on section 4.1.3, and §361: comments on section 4.4 2 (e) of Annex I.
Certain categories of machinery to be installed in buildings are also subject to Directive 89/106/EC on Construction Products, such as, for example, powered gates, doors, windows, shutters and blinds – see §92: comments on Article 3.
Article 2 (a) – fourth indent
. . .
‘machinery’ means:
. . .
- assemblies of machinery referred to in the first, second and third indents or partly completed machinery referred to in point (g) which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole,
. . .
§38 Assemblies of machinery
The fourth indent deals with assemblies of machinery consisting of two or more machines or partly completed machines assembled together for a specific application. Assemblies of machinery may be constituted by two units such as, for example, a packaging machine and a labelling machine, or by several units assembled together, for example, in a production line.
The definition of assemblies of machinery indicates that assemblies are arranged and controlled so that they function as an integral whole in order to achieve the same end. For a group of units of machinery or partly completed machinery to be considered as an assembly of machinery, all of these criteria must be fulfilled:
- the constituent units are assembled together in order to carry out a common function, for example, the production of a given product;
- the constituent units are functionally linked in such a way that the operation of each unit directly affects the operation of other units or of the assembly as a whole, so that a risk assessment is necessary for the whole assembly;
- the constituent units have a common control system – see §184: comments on section 1.2.1, and §203: comments on section 1.2.4.4 of Annex I.
A group of machines that are connected to each other but where each machine functions independently of the others is not considered as an assembly of machinery in the above sense.
The definition of assemblies of machinery does not extend to a complete industrial plant consisting of a number of production lines each made up of a number of machines, assemblies of machinery and other equipment, even if they are controlled together by a single production control system. Only if the plant (which may be any combination of machinery, partly completed machinery and other equipment resulting in machinery subject to the Machinery Directive) forms a single integrated line is it subject to the Machinery Directive as an assembly. So for the purpose of applying the Machinery Directive, most industrial plants can be divided into different sections, each of which may be a distinct assembly (of machinery) or even an independent machine (e.g. a mixing vessel). Even a single production line may be divided into separate assemblies and/or machines if there is no safety related connection between constituent assemblies or machinery.
However, where risks are created by the interfaces with other sections of the plant these must be covered by the installation instructions – see §264: comments on section 1.7.4.2 (i) of Annex I.
It should also be noted that the placing on the market of equipment installed in industrial plants that is not in the scope of the Machinery Directive may be subject to other EU internal market legislation – see §89 to §92: comments on Article 3.
The person constituting an assembly of machinery is considered as the manufacturer of the assembly of machinery and is responsible for ensuring that the assembly as a whole complies with the health and safety requirements of the Machinery Directive – see §79: comments on Articles 2 (i). In some cases, the manufacturer of the assembly of machinery is also the manufacturer of the constituent units. However, more frequently, the constituent units are placed on the market by other manufacturers, either as complete machinery that could also operate independently according to the first, second or third indents of Article 2 (a), or as partly completed machinery according to Article 2 (g).
If the units concerned are placed on the market as complete machinery that could also operate independently, they must bear the CE marking and be accompanied by an EC Declaration of Conformity – see §103: comments on Article 5 (1). If they are placed on the market as partly completed machinery, they must not bear the CE-marking, but note that if other legislation providing for CE marking also apply (e.g. ATEX Directive, Radio Equipment Directive, etc.), a CE marking will have been applied, in which case the Declaration of Conformity should state it only covers that legislation. In all cases the partly completed machinery must be accompanied by a Declaration of Incorporation under the Machinery Directive together with assembly instructions – see §104: comments on Articles 5 (2), and §131, comments on Article 13.
Assemblies of machinery are subject to the Machinery Directive because their safety depends not just on the safe design and construction of their constituent units but also on the suitability of the units linked together and the safety of the interfaces between them. At the interface modifications to or extra, guarding/protection devices may need to be designed and fitted so that the assembly as a whole is compliant. The risk assessment to be carried out by the manufacturer of an assembly of machinery must therefore cover both the suitability of the constituent units for the safety of the assembly as a whole and the hazards resulting from the interfaces between the constituent units. It must also cover any hazards resulting from the assembly that are not covered by the EC Declaration of Conformity (for machinery) or the Declaration of Incorporation and the assembly instructions (for partly completed machinery) supplied by the manufacturers of the constituent units.
The manufacturer of the assembly of machinery must:
- carry out the appropriate conformity assessment procedure for the assembly of machinery – see §127 to §130: comments on Article 12;
- affix a specific marking (for example, a specific plate) to the assembly of machinery with the information required by section 1.7.3 and, where appropriate, sections 3.6.2, 4.3.3 and 6.5 of Annex I, including the CE marking;
- draw up and sign an EC Declaration of Conformity for the assembly of machinery - see §103: comments on Article 5 (1).
- compile the technical file which must contain the results of the risk assessment and the design details of the interfaces (e.g. guards, linking conveyers, hoppers, feeders and electronic interface devices) between the items. It must also document any modifications that have been made to the constituent units when incorporating the new items into the assembly. The EC Declaration of Conformity for complete machines and the Declaration of Incorporation and the assembly instructions for partly completed machinery incorporated into the assembly of machinery must also be included in the technical file for the assembly of machinery – see §392: comments on Annex VII A 1 (a).
§39 Assemblies comprising new and existing machinery
The Machinery Directive applies to machinery when it is first placed on the market and put into service in the EU. This is, in general, new machinery – see §72: comments on Article 2 (h). Consequently, the assemblies of machinery referred to in the fourth indent of Article 2 (a) are often new assemblies of new machinery. For machinery in service (used at work), the employer must ensure that the conformity and safety of the machinery is maintained throughout its working life, according to the national regulations implementing Directive 2009/104/EC – see §140: comments on Article 15 and following the manufacturer’s instructions – see §272, comments on section 1.7.4.2 (r) of Annex I.
Where, one or more of the constituent units of existing assemblies of machinery may be replaced by new units, or new units may be added to an existing assembly of machinery, the question arises as to whether an assembly of machinery comprising new and existing units is, as a whole, subject to the Machinery Directive. It is not possible to give precise criteria for answering this question in each particular case. In doubt, it is therefore advisable for the person constituting such an assembly of machinery to consult the relevant national authorities. However, the following general guidance can be given:
- If the risk assessment[1] shows that the replacement or the addition of a constituent unit in an existing assembly of machinery does not add a new hazard, nor increase an existing risk
, no action is required according to the Machinery Directive for the parts of the assembly that are not affected by the modification. The same applies where there is a new hazard, or an increase in an existing risk, but the existing protective measures present on the assembly before the modification are still sufficient so that the assembly can still be considered safe after modification. However, for those parts of the assembly that are affected by the replacement or the addition of a constituent unit, action under the Machinery Directive will be required. The employer remains responsible for the safety of the whole assembly according to
the national provisions implementing Directive 2009/104/EC – see §140: comments on Article 15.
- If the risk assessment[2] for the new unit shows it does not have any safety implications (e.g. by requiring modifications) on the existing assembly and it is a complete machinery that could also operate independently, that bears the CE-marking and is accompanied by an EC Declaration of Conformity, then the addition of this new unit (as a complete machinery) into the existing assembly is to be considered as the installation of the new unit (machinery) and this does not give rise to a new conformity assessment, CE marking or EC Declaration of Conformity for either the new unit (machinery) or the assembly to which is added..
- However, if the new unit to be added to the assembly comprises partly completed machinery (PCM) as defined by Art. 2 (g) , which must be accompanied by a Declaration of Incorporation and assembly instructions, the person incorporating the PCM into the assembly is to be considered as the manufacturer of the new unit (as by incorporating the PCM in the assembly, ‘new’ machinery is being put into service). He must therefore assess any risks arising from the interface between the PCM, other equipment and the assembly of machinery, fulfil any relevant EHSRs that have not been applied by the manufacturer of the PCM, apply the assembly instructions, draw up an EC Declaration of conformity, compile the technical file for the modified parts of the assembly (essentially how the PCM has been put into service, including any changes to the existing assembly) and affix the CE marking to the new unit as assembled. For example, if a new automatic reel change unit, which is a partly completed machinery, is added to the end of a paper making line which will not affect the main parts of the line, then only the interface design and any modifications to the control system or to the existing assembly will need to be assessed for the purposes of CE marking the unit, as fitted.
- If the replacement or the addition of new constituent units in an existing assembly of machinery has a substantial impact on the operation or the safety of the assembly as a whole or involves substantial modifications of the assembly, it may be considered that the modification amounts to the constitution of a new assembly of machinery to which the Machinery Directive must be applied. In that case, the whole assembly, including all its constituent units, must comply with the provisions of the Machinery Directive. This may also be required if a new assembly of machinery is constituted from new and second-hand units.
Article 2 (a) – fifth indent
. . .
‘machinery’ means:
. . .
— an assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power source is directly applied human effort;
. . .
§40 Manually powered machinery for lifting loads
The fifth indent of the definition of machinery sets out an exception to the general rule that manually powered machinery is excluded from the Machinery Directive. Manually powered machinery intended for lifting loads, whether goods or persons or both, is subject to the Machinery Directive – see §328: comments on section 4.1.1 (a) of Annex I. Examples of such machinery include manually powered hoists and cranes, jacks, lifting tables, pallet and stacker trucks and mobile elevating work platforms. Products which do not lift a load but simply maintain it at a given height are not covered by this definition.
Article 2
. . .
(b) ‘interchangeable equipment’ means a device which, after the putting into service of machinery or of a tractor, is assembled with that machinery or tractor by the operator himself in order to change its function or attribute a new function, in so far as this equipment is not a tool;
§41 Interchangeable equipment
Interchangeable equipment referred to in Article 1 (1) (b) is defined in Article 2 (b). It should be noted that interchangeable equipment is also designated by the term
‘machinery’ used in the broad sense – see §33: comments on the first paragraph of
Article 2.
In the following comments, the different elements of the definition of interchangeable equipment are examined in turn.
. . . after the putting into service of machinery or of a tractor . . .
Interchangeable equipment is equipment that is designed and constructed in order to be assembled with machinery after the basic machinery has been put into service. Equipment that is assembled with machinery by the manufacturer when the machinery is placed on the market and that is not intended to be changed by the user is not considered as interchangeable equipment but is considered as part of the machinery.
One or more items of interchangeable equipment may be supplied by the machinery manufacturer together with the basic machinery or by another manufacturer. In either case, each item of interchangeable equipment shall be considered as a separate product and must be accompanied by a separate EC Declaration of Conformity, bear the CE marking and be supplied with its own instructions.
. . . is assembled with that machinery or tractor by the operator himself . . .
The fact that interchangeable equipment is intended to be assembled with the machinery implies that the combination of the basic machinery and the interchangeable equipment functions as an integral whole. Equipment that is used with the machinery but not assembled with it is not to be considered as interchangeable equipment. Equipment that requires significant modifications to the “parent machine” by the user when adding and removing the item or it is not designed to be removed or added on a routine basis, is not regarded as “interchangeable equipment”.
. . . in order to change its function or attribute a new function, in so far as this equipment is not a tool . . .
Interchangeable equipment should not be confused with spare parts that do not change the function of the machinery or attribute a new function to it but that are simply intended to replace worn or damaged parts.
Interchangeable equipment is also distinguished from tools, such as, for example, blades, bits, simple earthmoving buckets, etc. which do not change or attribute a new function to the basic machinery. Tools as such are not subject to the Machinery Directive (although the machinery manufacturer must specify the essential characteristics of tools which may be fitted to the machinery – see §268: comments on section 1.7.4.2 (n) of Annex I.
Examples of interchangeable equipment include equipment assembled with agricultural or forestry tractors for functions such as ploughing, harvesting, lifting or loading, and equipment assembled with earth-moving equipment, for functions such as drilling or demolition. Work platforms intended to be assembled with lifting machinery in order to modify its function for the purpose of lifting persons are interchangeable equipment – see §388: comments on Annex IV, item 17. Other examples of interchangeable equipment are supports intended for assembly with portable hand-held machines to convert them into fixed machines and interchangeable power-feed units for woodworking machinery.
Interchangeable equipment may be placed on the market by the manufacturer of the basic machinery or by another manufacturer. In either case, the manufacturer of the interchangeable equipment must specify in his instructions the machinery with which it can be safely assembled and used, either by reference to the technical characteristics of the machinery or, where necessary, by reference to specific models of machinery. He must also provide the necessary instructions for safe assembly and use of the interchangeable equipment – see §264: comments on section 1.7.4.2 (i) of Annex I.
The manufacturer of the interchangeable equipment must ensure that the combination of the interchangeable equipment and the basic machinery with which it is intended to be assembled fulfils all the relevant essential health and safety requirements of Annex I and must carry out the appropriate conformity assessment procedure.
It should be noted that the assembly of interchangeable equipment with basic machinery may have the effect of creating a combination that belongs to one of the categories of machinery listed in Annex IV. This may be the case, for example, if a support is assembled with hand-held woodworking machine to convert it into fixed machinery such as a circular saw bench or a vertical spindle moulding machine; or when a work platform is assembled with lifting machinery in order to modify its function for the purpose of lifting persons.[3] In such cases, the manufacturer of the interchangeable equipment must carry out a risk assessment for the combination of the interchangeable equipment and the basic machinery and apply one of the conformity assessment procedures foreseen for Annex IV machinery – see §129 and §130: comments on Article 12. The conformity assessment must ensure that the assembly of the interchangeable equipment and the type or types of basic machinery with which it is intended to be assembled complies with all the relevant essential health and safety requirements of Annex I.
The requisite information relating to the conformity assessment of the combination of the interchangeable equipment and the basic machinery shall be mentioned in the EC Declaration of conformity for the interchangeable equipment. The instructions for the interchangeable equipment must also specify the type or types of basic machinery with which the equipment is intended to be assembled and include the necessary assembly instructions – see §264: comments on section 1.7.4.2 (i) and §416: guidance document on interchangeable equipment for lifting persons.
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Article 2
. . .
(c) ‘safety component’ means a component:
- which serves to fulfil a safety function,
- which is independently placed on the market,
- the failure and/or malfunction of which endangers the safety of persons, and
- which is not necessary in order for the machinery to function, or for which normal components may be substituted in order for the machinery to function.
An indicative list of safety components is set out in Annex V, which may be updated in accordance with Article 8(1)(a);
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§42 Safety components
Safety components referred to in Article 1 (1) (c) are defined in Article 2 (c). It should be noted that safety components are also designated by the term ‘machinery’ used in the broad sense – see §33: comments on the first paragraph of Article 2.
The safety function serves to fulfil a protective measure to eliminate or, if not possible, to reduce a risk: this action being either inherent in the design or triggered either automatically, or through intervention by the operator on the safety component (as is the case with an emergency stop device, seat belt or two-hand control device).
Many machinery components are critical for the health and safety of persons. However, purely operational components, by virtue of the fourth indent in Article 2 (c) above, are not considered as safety components. Safety components are components intended by the component manufacturer to be fitted to machinery specifically to fulfil a protective role, in addition to any operational duty. Components placed independently on the market that are intended by the component manufacturer for functions that are both safety and operational functions, or that are intended by the component manufacturer to be used either for safety or for operational functions are to be considered as safety components. For example, a hydraulic valve designed and specified as being capable of performing a safety function as well as normal production use, is a “safety component” where other parts of the definition are met. However, a similar valve where the manufacturer markets it only for normal production use would not be considered a safety component.
The exclusion of low-voltage switchgear and control gear set out in the fifth indent of Article 1 (2) (k) does not apply to electrical safety components – see §68: comments on Article 1 (2) (k).
The last sentence of the definition refers to the list of safety components given in Annex V. Annex V lists categories of safety component that are commonly fitted to machinery.
Examination of the list helps to understand the definition of 'safety component'. However, the list is indicative, not limitative. In other words, any component that complies with the definition set out in Article 2 (c) is to be considered as a safety component subject to the Machinery Directive, even if it is not it is included in the list given in Annex V.
If, in future, safety components are identified which are not included in the list given in Annex V, for example, innovative safety components, the Commission can adopt an implementing Decision to update the list, after consulting the Machinery Committee according to the Regulatory procedure with scrutiny – see §116: comments on Article 8 (1) (a), and §147: comments on Article 22 (3). However, this procedure is not a requirement for the item to be considered as a “safety component” as this list is only indicative, this guide includes, at §389, some other items that meet the definition of “safety components” that are not currently on the list in Annex V.
The second indent of the definition set out in Article 2 (c) implies that only safety components independently placed on the market are subject as such to the Machinery Directive. Safety components manufactured by a machinery manufacturer to be incorporated in his own machinery are not subject to the Directive as such, although they must enable the machinery to comply with the relevant essential health and safety requirements. It should be noted that when such a manufacturer supplies safety components as spare parts to replace the original safety components on machinery he has placed on the market, they are not subject to the Machinery Directive – see §48: comments on Article 1 (2) (a).
With respect to the conformity assessment procedure applicable to safety components, it should be noted that certain safety components are listed in Annex IV – see §129 and §130: comments on Article 12, and §388: comments on items 19 to 23 of Annex IV.
Specific guidance on safety fences as a safety component is given in §411.
Article 2
. . .
(d) ‘lifting accessory’ means a component or equipment not attached to the lifting machinery, allowing the load to be held, which is placed between the machinery and the load or on the load itself, or which is intended to constitute an integral part of the load and which is independently placed on the market; slings and their components are also regarded as lifting accessories;
§43 Lifting accessories
Lifting accessories referred to in Article 1 (1) (d) are defined in Article 2 (d). It should be noted that lifting accessories are also designated by the term ‘machinery’ used in the broad sense – see §33: comments on the first paragraph of Article 2.
Lifting machinery usually has a device for holding the load such as, for example, a hook. Such load holding devices incorporated into lifting machinery are not to be considered as lifting accessories. However, given the varied shape, size and nature of the loads to be lifted, equipment is often placed between the holding device of the lifting machinery and the load, or on the load itself, in order to hold the load during the lifting operation. Such equipment is referred to as a lifting accessory. Products that are independently placed on the market to be incorporated into loads for this purpose are also considered as lifting accessories.
Equipment placed between the holding device of lifting machinery and the load is considered as a lifting accessory, even if it is placed on the market with the lifting machinery or with the load.
The last part of the definition of ‘lifting accessories’ states:
. . . slings and their components are also regarded as lifting accessories
This implies that equipment intended to be used as an independent sling or in a variety of combinations in slings to be made up by a user, for example, to make up a multi-leg sling, is considered as a lifting accessory. On the other hand, components that are intended to be incorporated in slings and that are not intended to be used independently to make up a sling are not considered as lifting accessories – see §358: comments on section 4.3.2 of Annex I.
The Machinery Committee has drawn up a list of various categories of equipment used for lifting operations, indicating which categories are considered as lifting accessories: see section §412. The list is not exhaustive but is intended to facilitate uniform interpretation and application of the Machinery Directive to lifting accessories.
Lifting accessories are subject to certain specific essential health and safety requirements in Part 4 of Annex I – see §337 to §341: comments on sections 4.1.2.3,
4.1.2.4 and 4.1.2.5, §358: comments on section 4.3.2, and §360: comments on section 4.4.1 of Annex I.
Article 2
. . .
(e) ‘chains, ropes and webbing’ means chains, ropes and webbing designed and constructed for lifting purposes as part of lifting machinery or lifting accessories;
§44 Chains, ropes and webbing
Chains, ropes and webbing referred to in Article 1 (1) (e) are defined in Article 2 (e).
The products designated by the terms 'chains, ropes and webbing' are chains, ropes and webbing designed and constructed for incorporation into lifting machinery or lifting accessories for lifting purposes – see §328: comments on section 4.1.1 (a) of Annex I. Chains, ropes or webbing designed for purposes other than lifting are not subject to the Machinery Directive as such. However, chains, ropes or webbing that are designed, constructed and specified by the manufacturer for dual or multiple purposes including lifting purposes are subject to the Directive.
Since chains, ropes and webbing for lifting purposes are among the products designated by the term ‘machinery’ used in the broad sense – see §33: comments on the first paragraph of Article 2 - manufacturers of chains ropes and webbing for lifting purposes must fulfil all of the obligations set out in Article 5 (1) – see §103: comments on Article 5 (1).
It should be noted that the products designated by the terms 'chains, ropes and webbing' are the products placed on the market by the chain, rope or webbing manufacturer in the form of bulk reels, drums, rolls, coils or bundles of chain, rope or webbing. They may be supplied by the chain, rope or webbing manufacturer to distributors, to manufacturers of lifting machinery or lifting accessories, or to users.
The obligations set out in Article 5 (1) apply when the chains, ropes or webbing are first placed on the market. The distributor or user does not become a manufacturer in the sense of the Directive by cutting individual lengths for incorporation into lifting machinery or lifting accessories. Therefore, the obligations set out in Article 5 (1) do not apply again to lengths of chain, rope or webbing cut from the products already placed on the market by the chain, rope or webbing manufacturer. Such lengths are to be considered as components of the lifting machinery or the lifting accessories into which they are incorporated.
However, distributors of chains, ropes and webbing must ensure that the relevant EC Declaration of Conformity, the reference of the certificate setting out the characteristics of the chain, rope or webbing and the manufacturer's instructions are supplied with the cut length of chain, rope or webbing to manufacturers of lifting machinery or lifting accessories or to users – see §83: comments on Article 2 (i), and §357: comments on section 4.3.1 of Annex I.
Article 2
. . .
(f) ‘removable mechanical transmission device’ means a removable component for transmitting power between self-propelled machinery or a tractor and another machine by joining them at the first fixed bearing. When it is placed on the market with the guard it shall be regarded as one product;
§45 Removable mechanical transmission devices
Removable mechanical transmission devices referred to in Article 1 (1) (f) are defined in Article 2 (f). It should be noted that removable mechanical transmission devices are also designated by the term 'machinery' used in the broad sense – see §33: comments on the first paragraph of Article 2.
Removable mechanical transmission devices are subject to specific essential health and safety requirements in Part 3 of Annex I – see §319: comments on section 3.4.7 of Annex I.
It should be noted that guards for removable mechanical transmission devices are included as item 1 in the indicative list of safety components set out in Annex V. When they are placed on the market independently, such guards are therefore subject to the Machinery Directive as safety components. However, according to the second sentence of the above definition, when a removable mechanical transmission device is placed on the market together with its guard, it is subject to the Machinery Directive as a single
product.
With respect to the conformity assessment procedure, it should also be noted that removable mechanical transmission devices including their guards are listed in Annex IV, item 14, and guards for removable mechanical transmission devices are listed in Annex IV, item 15.
Article 2
. . .
(g) ‘partly completed machinery’ means an assembly which is almost machinery but which cannot in itself perform a specific application. A drive system is partly completed machinery. Partly completed machinery is only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment, thereby forming machinery to which this Directive applies;
§46 Partly completed machinery
Partly completed machinery (PCM) referred to in Article 1 (g) is defined in Article 2 (g). It should be noted that partly completed machinery is not among the products designated by the term 'machinery' used in the broad sense – see §33: comments on the first paragraph of Article 2. Partly completed machinery cannot be considered as interchangeable equipment.
The placing on the market of partly completed machinery is subject to a specific procedure – see §104: comments on Article 5 (2), §131: comments on Article 13, §384 and §385: comments on Annex II 1 B, and comments on Annexes VI and VII.
Partly completed machinery subject to the Machinery Directive is a product intended to form machinery that is in the scope of the Machinery Directive after incorporation.
'An assembly which is almost machinery' means that partly completed machinery is a product that is similar to machinery in the strict sense referred in Article 1 (1) (a), that is to say, an assembly consisting of linked parts or components at least one of which moves, but which lacks some elements necessary to perform its specific application. Partly completed machinery must thus undergo further construction in order to become final machinery that can perform its specific application. As an example, industrial robots are usually designed without a specific application until incorporated into the final machinery – see Article 2(g) of the Machinery Directive. The manufacturer of the final machinery takes the necessary measures so that the robot can perform its specific application safely within the assembly. In practice, only an industrial “stand and function alone-robot” provided with both an end-effector and control system so that it can itself perform a specific application, is a complete machinery under the Machinery Directive.
This further construction is not the fitting of a drive system to machinery supplied without a drive system where the drive system to be fitted is covered by the manufacturer's conformity assessment – see §35: comments on the first indent of Article 2 (a) – or the connection on site or with sources of energy or motion – see §36: comments on the second indent of Article 2 (a). Partly completed machinery should also be distinguished from machinery ready to be installed on a means of transport or in a building or a structure – see §37: comments on the third indent of Article 2 (a).
Machinery that meets the definition in the first three indents of Article 2(a) so it can in itself operate independently, performing its specific application – see §35: comments on the first indent of Article 2 (a) – but which only lacks the necessary protective means or safety components, such as guards, is not to be considered as partly completed machinery. Such incomplete machinery does not meet the requirements of the Machinery Directive and must not be CE marked and cannot be placed on the EU/EEA market – see §103: comments on Article 5 (1).
Machinery constructed in situ is not to be considered a PCM because on arrival at site it comprises a number of parts which may not be compliant (unless one or more of those parts meet the definition of a PCM, which includes being specifically intended for incorporation). It is still a machinery to which Machinery Directive applies so it must undergo conformity assessment and CE marking before it is first put into service.
Sometimes complete machinery missing some parts is confused with a PCM. If the missing parts are not constitutional parts of the machinery (e.g. a motor as a source of energy) and do not give rise to substantial impact on the safety of that machinery (so must be considered as part of conformity assessment) and the machinery manufacturer’s instructions provide clear information for the installation of the missing parts such that the safety and compliance of the final machinery is guaranteed with the
Machinery Directive, then the completion of the machinery can be made later according to those instructions, prior to being put into service for the first time, according to Art 2(a) second indent.
Since partly completed machinery is 'almost machinery', it is to be distinguished from machinery components that are not subject to the Machinery Directive as such – see §35: comments on the first indent of Article 2 (a). Machinery components can usually be integrated into a wide range of categories of machinery with different applications.
The second sentence of the definition of partly completed machinery states:
. . . A drive system is partly completed machinery.
This provision also applies to drive systems ready to be fitted to machinery and not to the individual components of such systems.
For example, an internal combustion engine or a high voltage electric motor placed on the market ready to be fitted, i.e. with the connections necessary for the fitting, to machinery that is subject to the Machinery Directive are to be considered as partly completed machinery. Electric motors that are marketed for a wide variety of uses and hence not specifically designed or equipped for fitting to a particular type of machinery are not partly completed machinery.
It should be noted that most low voltage (50 - 1000 volts a.c. or between 75 and 1500 volts d.c.) electric motors are excluded from the scope of the Machinery Directive and are subject to the Low Voltage Directive 2014/35/EU, unless they are subject to ATEX Directive 2014/34/EU – see §69: comments on Article 1 (2) (k) –, or form part of the drive system discussed above as PCM. It should also be noted that low voltage electric motors for ATEX application are excluded from the LVD. Consequently such motors fall under the scope of the Machinery Directive – see §69: comments on Article 1 (2) (k).
Machinery Directive does not prescribe requirements for PCM manufacturers to meet the EHSRs of Annex I. All EHSRs met by the PCM must be declared on the accompanying Declaration of Incorporation – see §385: comments on Annex II 1 B. PCMs must be accompanied by assembly instructions which should include the essential information to enable safe incorporation, including, where relevant, for the final machine's control system, the relevant data on safety performance/reliability.
Manufacturers of final machinery are advised to check the Declaration of Incorporation, technical specifications and the assembly instructions prior to purchasing, to satisfy themselves that the PCM is suitable for integration into the final machinery.
The Machinery Directive does not apply as such to separate machinery components or subassemblies such as, for example seals, ball-bearings, pulleys, elastic couplings, solenoid valves, hydraulic cylinders, and the like, that do not have a specific application and that are intended to be incorporated into machinery; unless they fulfil one of the other definitions of products, e.g. a safety component, that are in the scope of the Machinery Directive by virtue of Art 2 (b) to (f), or are partly completed machinery as defined by Art. 2(g). The complete machinery incorporating such components must comply with the relevant essential health and safety requirements. The machinery manufacturer must therefore choose components with adequate specifications and characteristics. Component manufacturers may provide customers with relevant technical documentation to allow such subassemblies and components, to be installed correctly and safely. As these items are not in the scope of the Machinery Directive, the component manufacturers are not required to provide any declarations of conformity or to produce a technical file according to Annex VII or assembly instructions to Annex VI.
§47 Products excluded from the scope of the Machinery Directive
The scope of the Machinery Directive set out in Article 1 (1) is limited in two ways:
- Certain products corresponding to the definitions set out in Articles 2 (a) to (g) are explicitly excluded from the scope of the Machinery Directive. The list of explicitly excluded products is set out in Article 1 (2), (a) to (l).
- According to Article 3 – Specific Directives, the Machinery Directive does not apply to products listed in Article 1 (1) for the risks covered more specifically by other EU legislation. When these specific Directives cover all the risks associated with the products concerned, such products are entirely excluded from the scope of the Machinery Directive. When the specific Directives only cover certain of the risks associated with the products concerned, as for example ignition sources (according to the ATEX Directive 2014/34/EU), such products remain in the scope of the Machinery Directive for the other risks – see §89 to §91: comments on
Article 3.
Article 1 (2)
(a) Safety components intended to be used as spare parts to replace identical components and supplied by the manufacturer of the original machinery;
§48 Safety components intended to be used as spare parts to replace identical components and supplied by the manufacturer of the original machinery
The exclusion set out in Article 1 (2) (a) concerns only components identical to components manufactured by the machinery manufacturer and fitted to their own machinery. Such components are not subject to the Machinery Directive as such because they are not placed on the market independently – see §42: comments on
Article 2 (c).
When such a machinery manufacturer supplies identical components as spare parts to replace the original components, those spare parts do not thereby become subject to the Machinery Directive. It is important not to take the term “identical” too far, it should be taken to refer to the identical parameters of the unit. This means the exemption also applies in cases where the exact same components are no longer available and the machinery manufacturer supplies spare parts with the identical safety function and with the identical safety performance as the components that were originally fitted to the machinery.
Article 1 (2)
. . .
(b) Specific equipment for use in fairgrounds and/or amusement parks;
§49 Equipment for use in fairgrounds and/or amusement parks
Equipment designed and constructed specifically for use in fairground or amusement parks is excluded from the scope of the Machinery Directive by Article 1 (2) (b). The design and construction of such equipment is not subject to any EU legislation and may therefore be subject to national regulations. It can be noted that there are two European standards for such equipment[4].
Use of such equipment by workers (for example, during erection, dismantling or maintenance operations) is subject to national provisions implementing Directive 2009/104/EC on use of work equipment by workers at work – see §140: comments on
Article 15.
Article 1 (2)
. . .
(c) machinery specially designed or put into service for nuclear purposes which, in the event of failure, may result in an emission of radioactivity;
§50 Machinery for nuclear purposes
The exclusion set out in Article 1 (2) (c) concerns machinery specially designed for the purposes of the nuclear power industry or for the production or processing of radioactive materials, the failure of which may result in an emission of radioactivity.
Machinery used in the nuclear power industry, such as fork lift trucks, cranes and generators, which do not give rise to a risk of emission of radioactivity and/or failure of which do not directly generate radioactive emission, are not excluded from the scope of the Machinery Directive.
The machinery concerned by the exclusion set out in Article 1 (2) (c) is also to be distinguished from machinery incorporating radioactive sources, for example, for the purposes of measurement, non-destructive testing or preventing the accumulation of static electric charge. As they are not designed or used for nuclear purposes and thus are not excluded from the scope of the Machinery Directive – see §232: comments on section 1.5.10 of Annex I.
It should be noted that the use of radioactive sources may be subject to authorisation and control according to the national provisions implementing Directive 96/29/Euratom and Directive 2003/122/Euratom[5].
Article 1 (2)
. . .
(d) weapons, including firearms;
§51 Weapons, including firearms
As explained in Recital 6, the exclusion of weapons, including firearms, set out in Article 1 (2) (d), is to be understood in light of the scope of the EU legislation on control of the acquisition and possession of weapons set out in Annex I to Council Directive 91/477/EEC18. Section III (b) of that Annex excludes devices designed for industrial or technical purposes provided that they can be used for the stated purpose only.
Consequently, the exclusion of weapons, including firearms, from the scope of the Machinery Directive does not extend to cartridge-operated fixing and other cartridgeoperated impact machinery designed for industrial or technical purposes – see §9: comments on Recital 6.
§52 Means of transport
The exclusions relating to various means of transport are set out in the five indents of Article 1 (2) (e). In the following comments, these indents are examined in turn.
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Article 1 (2) (e) – first indent19 the following means of transport:
. . .
— agricultural and forestry tractors for the risks covered by Directive 2003/37/EC, with the exclusion of machinery mounted on these vehicles.
. . .
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§53 Agricultural and forestry tractors
The exclusion set out in the first indent of Article 1 (2) (e) concerns agricultural and forestry tractors covered by Regulation 167/2013 on the approval and market surveillance of agricultural and forestry vehicles (Tractors) which replaced Directive 2003/37/EC on 1st January 2016. The amendment brought to Article 1(2)(e) of the Machinery Directive, is removing the reference to the exclusion being only for the risks covered by that Directive. Such tractors supplied under Regulation 167/2013 as of 1 January 2016 are completely excluded from the Machinery Directive. However, there is a two-year transition period where tractors supplied under national legislation implementing Directive 2003/37/EC can still be supplied up to 31st December 2017, and are thus also in scope of the Machinery Directive 2006/42/EC.
- OJ L 256, 13.9.1991, p. 51.
- Article 1(2)(e) was amended by Regulation (EU) 167/2013 on the approval and market surveillance of agricultural and forestry vehicles.
This change was made because at the time the new Machinery Directive was adopted; the Tractors Directive did not deal with all the risks associated with the use of tractors. The new Regulation 167/2013 was drafted to cover all risks including those previously covered by the Machinery Directive, and so a complete exclusion could be made. This change was anticipated when the Machinery Directive 2006/42/EC was adopted, the following joint declaration was made by the European Parliament, the Council and the Commission:
The Parliament, the Council and the Commission declare that, in order to cover all aspects related to the health and safety of agricultural and forestry tractors in one harmonising Directive, the Directive 2003/37/EC on type-approval of agricultural and forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units needs to be modified so as to address all the relevant risks of the Machinery Directive.
Such a modification of Directive 2003/37/EC should include an amendment of the Machinery Directive, in order to delete the expression “for the risks” in Article 1 (2) (e), first indent.
The Commission recognises the need to include in the agricultural and forestry tractors directives further requirements for risks not yet covered by these directives. To this end, the Commission is considering appropriate measures that include references to United Nations regulations, CEN and ISO standards and OECD codes.
It is important to note that the exclusion relating to agricultural and forestry tractors applies only to the tractors themselves and not to their trailers, to towed or pushed machinery or to mounted or semi-mounted machinery on the tractor.
Examples of mounted and semi-mounted machinery that are in scope of the Machinery Directive are: telescopic booms; digging equipment; post drivers; cutting devices mounted under tractors and equipment for vegetation maintenance. Where the tractor is designed with such items fitted in the production process, whether an integral part of the tractor or not, they are still considered as being “mounted” and so are in scope of the Machinery Directive. Where the “vehicle” is primarily designed for a task such that it does not meet the definition of an agricultural vehicle in Regulation (EU) No 167/2013, such as some models of telescopic material handler, then it is considered a product under the Machinery Directive.
Trailers and interchangeable towed machinery are in the scope of both Tractors Regulation 167/2013 and the Machinery Directive.
The requirements for the safe road circulation of such trailers and towed machinery are harmonised by Regulation (EU) No 167/2013 while the health and safety requirements of such machinery remain subject to the Machinery Directive.
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Article 1 (2) (e) – second indent
. . . the following means of transport:
. . .
— motor vehicles and their trailers covered by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers, with the exclusion of machinery mounted on these vehicles,
. . .
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§54 Four-or-more-wheeled road vehicles and their trailers
The exclusion set out in the second indent of Article 1 (2) (e) concerns motor vehicles and their trailers. When Directive 2006/42/EC was adopted, the type-approval of such vehicles was covered by Council Directive 70/156/EEC. As from 29 April 2009, Directive 70/156/EEC is replaced by Directive 2007/46/EC[6] This Directive applies to powerdriven vehicles having at least four wheels, with a maximum design speed exceeding 25 km/h, designed and constructed in one or more stages for use on the road, and of systems, components and separate technical units designed and constructed for such vehicles, as well as non-self-propelled vehicles on wheels designed and constructed to the towed by a motor vehicle.
Article 2 (3) of Directive 2007/46/EC foresees the possibility of optional type-approval or individual approval for mobile machinery, while stating that such optional approvals shall be without prejudice to the application of the Machinery Directive 2006/42/EC. Consequently, any mobile machinery subject to type-approval or individual approval for circulation on the road remains subject to the Machinery Directive for all risks other than those linked to road circulation.
Vehicles not intended for use on the road such as, for example, off-road quads, ATVs, go-karts, golf-carts buggies and snowmobiles, are subject to the Machinery Directive, unless they are exclusively intended for competition – see §56: comments on Article 1 (2) (e) – fourth indent.
The same is true of vehicles with a maximum design speed not exceeding 25 km/h such as, for example, certain compact road sweepers.
Machinery mounted on road vehicles or trailers such as, for example, loader cranes, taillifts, vehicle or trailer-mounted compressors, vehicle-mounted compaction systems, vehicle mounted concrete mixers, skip loaders, powered winches, tipper bodies and vehicle or trailer-mounted mobile elevating work platforms, are subject to the Machinery Directive – see §37: comments on Article 2 (a) – third indent.
Article 1 (2) (e) – third indent
. . .
— vehicles covered by Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two or three-wheel motor vehicles (2), with the exclusion of machinery mounted on these vehicles,
. . .
§55 Two- and three-wheeled road vehicles
The exclusion set out in the third indent of Article 1 (2) (e) concerns vehicles covered by Directive 2002/24/EC[7] which applies to two or three-wheel motor vehicles, whether twin-wheeled or otherwise, intended to travel on the road.
The exclusion does not apply to vehicles not intended for use on the road such as, for example, off-road motorcycles, which are thus subject to the Machinery Directive unless they are exclusively intended for competition – see §56: comments on Article 1 (2) (e) – fourth indent.
The exclusion does not apply to vehicles with a maximum design speed of less than 6 km/h, pedestrian controlled vehicles, vehicles intended for use by the physically handicapped, off-road vehicles, or electrically power assisted cycles (EPACs or pedelecs) that are outside the scope of Directive 2002/24/EC. These categories of two or three-wheel motor vehicles are therefore subject to the Machinery Directive.
Hoverboards or self-balancing scooters, which commonly have a single or pair of wheels on either side, are also subject to the Machinery Directive unless explicitly covered by the Toys Directive 2009/48/EC[8].
Article 1 (2) (e) – fourth indent
. . .
— motor vehicles exclusively intended for competition,
. . .
§56 Motor vehicles intended for competition
The exclusion set out in the fourth indent of Article 1 (2) (e) concerns motor vehicles intended for competition. Such vehicles are excluded from the scope of the Machinery Directive whether they are intended for road use or for off-road use.
The exclusion concerns vehicles exclusively intended for competition, thus, for example, vehicles intended for leisure use that may also be used for informal competitions are not excluded. The main criterion to be applied to judge whether vehicles are to be considered as exclusively intended for competition is whether they are designed according to the technical specifications laid down by one of the officially recognised racing associations.
For competition motorcycles, competition quads or All-Terrain Vehicles (ATVs) and competition snowmobiles, the technical specifications are laid down by the FIM (Fédération Internationale de Motocyclisme) and its national affiliated federations. To assist market surveillance authorities to distinguish competition models from others, the FIM publishes on its Website the list of competition motorcycles, quads and snowmobiles that comply with its technical specifications and that participate in national or international motor sports competitions organized under the auspices of the international federation and its national affiliates.
Article 1 (2) (e) – fifth indent
. . .
— means of transport by air, on water and on rail networks with the exclusion of machinery mounted on these means of transport;
§57 Means of transport by air, on water and on rail networks
According to the exclusion set out in the fifth indent of Article 1 (2) (e), the Machinery Directive does not cover any kind of aircraft or means of water-borne transport. This exclusion applies as well to hovercrafts[9].
Craft subject to the Recreational Craft Directive 94/25/EC as amended by Directive 2003/44/EC are excluded from the scope of the Machinery Directive. The Machinery Directive does not therefore apply to inboard and stern-drive engines that are considered as part of the craft.
Concerning "unmanned aerial vehicles" or "drones", they can be considered as covered by the Machinery Directive 2006/42/EC as long as they are not treated as "means of transport", so not in the specific exclusion for aircrafts stated in the Directive (e.g. specially designed and constructed for military or police purposes or designed and constructed for transporting loads, as well as drones covered by the Directive 2009/48/EC for toys). In addition, other EU legislation can apply to drones according to the specific characteristics of the product, such as the Electromagnetic Compatibility (EMC) Directive 2014/30/EU or the Radio Equipment Directive (RED) 2014/53/EC.
However, the Machinery Directive is applicable to outboard engines, with the exception of the requirements that are specifically included in the Recreational Craft Directive
2013/53/EU relating to the owner’s manual, the handling characteristics of the craft, the starting of outboard engines and exhaust and noise emissions.
Machinery mounted on water-borne vessels, such as, for example floating cranes, drills, excavators and dredgers, are not excluded from the scope of the Machinery Directive. It should be noted that lifting appliances fitted on a means of transport are subject to the Machinery Directive – see §151: comments on Article 24.
The exclusion of means of transport on rail networks concerns machinery intended for the transport of persons and/or goods on international, national, regional, suburban or urban rail networks or on rail systems connected to such networks. Railway turnouts (also known as points or switches) are not covered by the Machinery Directive[10] and they are subject to Directive 2008/57/EC[11] on the interoperability of the rail system.
On the other hand, machinery intended for use on rail systems not connected to such networks such as, for example, self-propelled machinery running on rails for underground work, are in the scope of the Machinery Directive.
Machinery intended for use on rail networks that is not intended for the transport of persons and/or goods such as, for example, railbound machinery for the construction, maintenance and inspection of the rail track and structures, is also in the scope of the Machinery Directive. The same goes for machinery mounted on railbound vehicles, such as, for example, loader cranes and mobile elevating work platforms.
Article 1 (2)
(f) Seagoing vessels and mobile offshore units and machinery installed on board such vessels and/or units;
§58 Seagoing vessels and mobile offshore units and machinery installed on board such vessels and/or units
Seagoing vessels and mobile offshore units such as, for example, mobile drilling rigs, and machinery installed on them are excluded from the scope of the Machinery Directive by Article 1 (2) (f) since they are subject to the Conventions of the International Maritime Organisation.
Some of the equipment concerned by this exclusion may also be subject to the Marine Equipment Directive 96/98/EC[12] as amended by Directive 2002/75/EC[13].
A mobile offshore unit is an offshore unit that is not intended to be located on the oil field permanently or for the long term, but is designed to be moved from location to location, whether or not it has a means of propulsion or of lowering legs to the seafloor. There are three main types of offshore units for drilling: jack-up; semi-submersible and drill-ship.
However, permanently placed floating units intended for production, such as, for example, FPSOs (Floating Production, Storage and Offloading installations – usually based on tanker designs) and FPPs (Floating Production Platforms – based on semisubmersible vessels) and the machinery installed on such units are not excluded from the scope of the Machinery Directive.
Machinery on permanently placed offshore platforms such as, for example, oil production rigs, and machinery which is designed to be used on both fixed and mobile offshore units is also subject to the Machinery Directive.
Article 1 (2)
- Machinery specially designed and constructed for military or police purposes;
§59 Machinery for military or police purposes
The exclusion set out in Article 1 (2) (g) applies to machinery specially designed and constructed for defence purposes or for the purpose of maintaining order. Ordinary machinery used by the armed forces or by the police but which is not specially designed for defence purposes or for the purpose of maintaining order is subject to the Machinery Directive.
In some countries, certain fire services belong to the military, however machinery designed for use by such fire-fighters is not thereby considered to be designed and constructed for military purposes and is thus subject to the Machinery Directive.
Article 1 (2)
- Machinery specially designed and constructed for research purposes for temporary use in laboratories;
§60 Machinery for research purposes
The exclusion set out in Article 1 (2) (h) was introduced since it was not considered reasonable to submit to the requirements of the Machinery Directive laboratory equipment specially designed and constructed for the needs of particular research projects. Consequently, the exclusion does not apply to machinery permanently installed in laboratories that may be used for general research purposes or to machinery installed in laboratories for purposes other than research such as, for example, for testing purposes.
The exclusion only applies to equipment designed and constructed for temporary research use, that is to say, equipment that will cease to be used when the research projects for which it was designed and constructed have been completed.
Article 1 (2)
(i) Mine winding gear;
§61 Mine winding gear
The exclusion set out in Article 1 (2) (i) concerns lifts equipping mine shafts. Mine winding gear is also excluded from the scope of the Lifts Directive 95/16/EC. It was considered that such lifts were specific installations the characteristics of which varied according to the site and which gave rise to few obstacles to trade. Mine winding gear thus remains subject to national regulations.
It should be noted that this exclusion concerns installations in the mine shaft. Lifts installed in other parts of a mine are not concerned by the exclusion and thus may be subject to either the Lifts Directive or the Machinery Directive, as the case may be – see §90: comments on Article 3, and §151: comments on Article 24.
Article 1 (2)
(j) Machinery intended to move performers during artistic performances;
§62 Machinery intended to move performers during artistic performances
The exclusion set out in Article 1 (2) (j) concerns machinery intended to be used to move performers in the course of the artistic performance. Such equipment is excluded from the scope of the Machinery Directive and the Lifts Directive 2014/33/EC (replacing Directive 95/16/EC from 20 April 2016), since application of the requirements of these Directives could be incompatible with the artistic function of the equipment concerned – see §151: comments on Article 24.
The exclusion does not apply to machinery intended only to move objects such as, for example, scenery or lighting, or to machinery intended to move persons other than the performers such as, for example, technicians.
It should also be noted that the exclusion does not concern other equipment, such as escalators or lifts, designed for moving persons in theatres or other entertainment premises for purposes not directly linked to the execution of the artistic performance. Such equipment is subject to either the Lifts Directive or the Machinery Directive, as the case may be – see §90: comments on Article 3, and §151: comments on Article 24.
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Article 1 (2)
(k) Electrical and electronic products falling within the following areas, insofar as they are covered by Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits:
— household appliances intended for domestic use,
— audio and video equipment,
— information technology equipment,
— ordinary office machinery,
— low-voltage switchgear and control gear, — electric motors.
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§63 Machinery covered by the Low Voltage Directive
One of the objectives of the revision of the Machinery Directive was to clarify the borderline between the scope of the Machinery Directive and the Low Voltage Directive 2014/35/EU[14] (replacing Directive 2006/95/EC from 20 April 2016) in order to provide greater legal certainty.
Article 1 (2) (k) lists the categories of low voltage electrical and electronic machinery that are excluded from the scope of the Machinery Directive.
Electrical machinery that is not in any of the categories listed in Article 1 (2) (k) (and that is not concerned by one of the other exclusions) is in the scope of the Machinery Directive. When such machinery has an electrical supply within the voltage limits of the Low Voltage Directive (between 50 and 1000 V for alternating current or between 75 and 1500 V for direct current), it must fulfil the safety objectives of the Low Voltage Directive – see §222: comments on section 1.5.1 of Annex I. However, in that case, the manufacturer’s EC Declaration of Conformity should not refer to the Low Voltage Directive.
On the other hand, low voltage electrical equipment placed on the market independently for incorporation into machinery is subject to the Low Voltage Directive as such[15].
Article 1 (2) (k) – first indent
. . .
- household appliances intended for domestic use,
. . .
§64 Household appliances intended for domestic use
Concerning the exclusion mentioned in the first indent of Article 1 (2) (k), several clarifications are necessary:
- the expression ‘household appliances’ designates equipment intended for housekeeping functions such as washing, cleaning, heating, cooling, cooking, etc. Examples of household appliances include washing machines, dish washers, vacuum cleaners and machinery for food preparation and cooking, and machinery for domestic personal care, such as hair dryers, shavers, etc. On the other hand, electrical gardening machinery or electrical power tools intended for construction and repair work in the home are not concerned by this exclusion and are subject to the Machinery Directive;
- the exclusion concerns appliances ‘intended for domestic use’, in other words, appliances intended for use by private persons (consumers) in the home environment. Thus appliances for the housekeeping functions mentioned above
that are intended for commercial or industrial use are not excluded from the scope of the Machinery Directive;
- electrically operated furniture, such as beds, chairs, tables, storage furniture including kitchen furniture, remain subject to the Machinery Directive as they are not household appliances of the types indicated above. However, where provided for medical purposes such that they are within scope of the Directive 93/42/EEC (as amended)[16] concerning medical devices, that Directive applies instead of the Machinery Directive.
While it is possible for a consumer to acquire an appliance intended for commercial use or for a commerce to acquire an appliance intended for domestic use, the criterion to be taken into account for determining the intended use is the use intended and stated by the manufacturer of the appliance in his product information or his Declaration of Conformity. Evidently, this statement must accurately reflect the foreseeable use of the product.
Article 1 (2) (k) – second indent
. . .
- audio and video equipment,
. . .
§65 Audio and video equipment
The exclusion mentioned in the second indent of Article 1 (2) (k) concerns equipment such as, for example, radio and television receivers, tape and video players and recorders, CD and DVD players and recorders, amplifiers and loud speakers, cameras and projectors.
Article 1 (2) (k) – third indent
. . .
- information technology equipment,
. . .
§66 Information technology equipment
The exclusion mentioned in the third indent of Article 1 (2) (k) concerns equipment used for the processing, conversion, transmission, storage, protection and retrieval of data or information. The equipment concerned includes, for example, computer hardware, communication network equipment and telephone and telecommunication equipment.
The exclusion does not extend to electronic equipment incorporated into machinery such as, for example, programmable electronic control systems, which is considered as an integral part of the machinery subject to the Machinery Directive and must enable the machinery to fulfil the relevant essential health and safety requirements of Annex I to the Directive. Certain devices incorporating information technology equipment may also be subject to the Machinery Directive as safety components.
Article 1 (2) (k) – fourth indent
. . .
- ordinary office machinery,
. . .
§67 Ordinary office machinery
The exclusion set out in the fourth indent of Article 1 (2) (k) applies to electrical equipment such as, for example, printers, copiers, fax machines, sorters, binders and staplers.
This exclusion does not concern machinery with similar functions intended for use in industries such as, for example, the printing or paper industries.
The exclusion of ordinary office machinery does not extend to electrically powered office furniture which is subject to the Machinery Directive.
Article 1 (2) (k) – fifth indent
. . .
- low-voltage switchgear and control gear,
. . .
§68 Low-voltage switchgear and control gear
Low voltage switchgear and control gear referred to in the fifth indent of Article 1 (2) (k) are devices for making and breaking the current in electrical circuits and associated control, measuring and regulating equipment for the control of electrical energy using equipment.
Such equipment is not subject to the Machinery Directive as such. Where such equipment is incorporated into machinery, it must enable the machinery to fulfil the relevant essential health and safety requirements of Annex I to the Machinery Directive.
It should also be noted that this exclusion does not apply to low voltage electrical safety components – see §42: comments on Article 2 (c).
Article 1 (2) (k) – sixth indent
. . .
- electric motors;
§69 Electric motors
The exclusion set out in the sixth indent of Article 1 (2) (k) implies that electric motors that are in the scope of the Low Voltage Directive 2014/35/EU (that is to say, electric motors with an electricity supply within the voltage limits and that are not listed in Annex II of that Directive) are subject to the Low Voltage Directive only.
An electric motor is a device for converting electrical energy into mechanical energy. The exclusion applies to the motor itself without a specific application and without additional mechanical elements of a drive system.
The exclusion also applies to low voltage electric motor-generators which are similar devices for converting mechanical energy into electrical energy. On the other hand, generator sets, comprising a source of mechanical energy such as, for example, an internal combustion engine, and an electric generator, are subject to the Machinery Directive.
The exclusion does not apply to electric motors that are intended for use in potentially explosive atmospheres and that are subject to the ATEX-Directive 2014/34/EU, because such motors are excluded from the Low Voltage Directive. Electric motors that are intended for use in potentially explosive atmospheres are therefore subject to the Machinery Directive.
Article 1 (2)
(l) the following types of high-voltage electrical equipment: - switch gear and control gear, - transformers.
§70 High-voltage electrical equipment
The high-voltage electrical equipment excluded by Article 1 (2) (l) comprises switch gear and control gear and transformers forming part of or connected to a high-voltage electricity supply (above 1000 V for alternating current or above 1500 V for direct current).
This high-voltage electrical equipment is not subject to the Machinery Directive as such. Where such equipment is incorporated into machinery, it must enable the machinery to fulfil the relevant essential health and safety requirements of Annex I to the Machinery Directive – see §222: comments on section 1.5.1 of Annex I.
Article 2
(h) ‘placing on the market’ means making available for the first time in the Community machinery or partly completed machinery with a view to distribution or use, whether for reward or free of charge;
§71 The definition of ‘placing on the market’
The term 'machinery' in the definition of ‘placing on the market’ is used in the broad sense, that is to say, the definition applies to the placing on the market of any of the products listed in Article 1, (a) to (f) and defined in Article 2 (a) to (f) – see §33: comments on the first paragraph of Article 2 – as well as to partly completed machinery.
The Machinery Directive applies to machinery or partly completed machinery placed on the EU market. It does not apply to products manufactured in the EU with a view to being placed on the market or put into service in countries outside the EU, although certain of these countries may have national regulations based on the Machinery Directive or accept machinery on their market that complies with the Directive.
§72 New and used machinery
Machinery is considered as placed on the market when it is made available in the EU for the first time. The Machinery Directive therefore applies to all new machinery placed on the market or put into service in the EU, whether such machinery is manufactured in the EU or outside the EU.
In general, the Machinery Directive does not apply to the placing on the market of used or second-hand machinery. In some Member States, the placing on the market of used or second-hand machinery is subject to specific national regulations. Otherwise the putting into service and use of second-hand machinery for professional use is subject to the national regulations on the use of work equipment implementing the provisions of Directive 2009/104/EC – see §140: comments on Article 15.
There is one exception to this general rule. The Machinery Directive applies to used or second-hand machinery that was first made available with a view to distribution or use outside the EU when it is subsequently placed on the market or put into service for the first time in the EU[17]. The person responsible for placing on the market or putting into service such used machinery for the first time in the EU, whether he is the manufacturer of the machinery, an importer, a distributor or the user himself, must fulfil all the obligations set out in Article 5 of the Directive.
The question arises as to when a transformation of machinery is considered as construction of new machinery subject to the Machinery Directive. It is not possible to give precise criteria for answering this question in each particular case. In doubt, it is therefore advisable for the person placing such rebuilt machinery on the market or putting it into service to consult the relevant national authorities.
§73 The stage at which the Machinery Directive applies to machinery
The definition of ‘placing on the market’, together with the definition of ‘putting into service’ given in Article 2 (k), determines the stage at which machinery must comply with the relevant provisions of the Directive. The manufacturer or his authorised representative must have fulfilled all their obligations relating to the conformity of machinery when it is placed on the market or put into service – see §103: comments on Article 5.
Placing on the market refers to each individual item of machinery or partly completed and not to a model or type. The relevant provisions of Directive 2006/42/EC therefore apply to all items of machinery or partly completed machinery placed on the market as from 29th December 2009 – see §153: comments on Article 26.
The Machinery Directive does not apply to machinery before it is placed on the market or put into service. In particular, machinery transferred by the manufacturer to his authorised representative in the EU in order to fulfil all or part of the obligations set out in Article 5 is not considered to be placed on the market until it is made available with a view to distribution or use – see §84 and §85: comments on Article 2 (j). The same goes for machinery still under construction, transferred by a manufacturer from manufacturing facilities outside the EU with a view to its completion in manufacturing facilities in the EU.
The manufacturer may need to operate or test the machinery or parts of it during construction, assembly, installation or adjustment before it is placed on the market or put into service. In that case, he must take the necessary precautions to protect the health and safety of operators and other exposed persons when carrying out such operations, in accordance with the national regulations on health and safety at work and on the use of work equipment implementing the provisions of Directives 89/391/EEC and 2009/104/EC – see §140: comments on Article 15. However, the machinery concerned is not required to comply with the provisions of the Machinery Directive until it is placed on the market or put into service.
Particular rules apply to machinery exhibited at trade fairs, exhibitions and demonstrations – see §108: comments on Article 6 (3).
§74 The legal and contractual forms of placing on the market
Placing on the market is defined as making machinery available with a view to distribution or use. Making machinery available implies that the machinery will be transferred from the manufacturer to another person such as a distributor or a user. However, it could be that the distribution operation is part of the manufacturer's own business, in which case it is when the item moves from the production area/factory to the distribution warehouse ready to be supplied. There is no restriction as to the legal or contractual form of this transfer.
In many cases, but not exclusively, placing on the market involves a transfer of the ownership of the machinery from the manufacturer to the distributor or user in exchange for payment (for example, sale or hire-purchase). In other cases, placing on the market may take other contractual forms (such as, for example, lease or rental). In such cases, the right to use the machinery is granted in exchange for payment, without transfer of ownership. The Machinery Directive applies to such machinery when it is first subject to a lease or rental contract in the EU. The Machinery Directive does not apply when used machinery that was first placed on the market according to the Machinery Directive is subject to subsequent lease or rental contracts in the EU. Rental or lease of used machinery may be subject to national regulations – see §140: comments on Article 15.
Placing on the market includes any offer for distribution, consumption or use on the EU market which could result in actual supply (e.g. an invitation to purchase, advertising campaigns) and this includes the general offer to supply into the EU on the internet. Therefore, if a machine is offered or advertised for supply (and hence use) on the internet into the EU it is considered as being placed on the market in the same way as a machine may be advertised for supply in a newspaper or magazine, and so the machinery must comply with the Machinery Directive.
Machinery is also considered to be placed on the market if it is made available with a
view to distribution or use free of charge (for example, as a gift or a loan).
Placing on the market is considered not to take place where a machine is introduced from a third country in the EU customs territory and has not been released for free circulation. This includes the cases of products in transit, placed in free zones, warehouses or temporary storage[18].
§75 Auctions
Auctions held in free zones
One of the ways in which machinery is placed on the market is through auctions. Such auctions may be held in a free zone[19]. The main purpose of holding auctions in a free zone is to sell new and used machinery from outside the EU for use in countries outside the EU. Machinery sold for that purpose is not considered to be placed on the market in the EU.
On the other hand, the machinery offered for sale at such an auction is considered to be placed on the market or put into service in the EU if and when it leaves the free zone in order to be distributed or used in the EU. If the machinery concerned is new or is used machinery that is placed on the market or put into service in the EU market for the first time, and if the manufacturer of the machinery concerned or his authorised representative has not fulfilled his obligations according to the Machinery Directive, the person who purchases the machinery at the auction and brings it from the free zone into the EU with a view to its distribution or use is to be considered as the person placing the machinery on the market or putting it into service in the EU and must fulfil all the obligations set out in Article 5.
Auctions held outside free zones
If an auction is held in the EU outside a free zone, it can be assumed that the machinery is being offered for sale with a view to its distribution or use in the EU and it is therefore to be considered as placed on the market in the EU.
If machinery offered for sale at an auction held in the EU outside a free zone is new, whether manufactured in or outside the EU, it must comply with the relevant provisions of the Machinery Directive. The same goes for used machinery offered for sale at such an auction if it is placed on the market in the EU for the first time – see §72: comments on Article 2 (h).
If the manufacturer of the machinery concerned or his authorised representative has not fulfilled his obligations according to the Machinery Directive, the person offering the machinery for sale at such an auction (the consignor) is to be considered as the person placing the machinery on the market in the EU and must therefore fulfil all the obligations of the manufacturer set out in Article 5. These obligations include ensuring that the machinery satisfies the relevant essential health and safety requirements, ensuring that the technical file is available, providing the instructions, carrying out the appropriate conformity assessment procedure, drawing up and signing the EC Declaration of Conformity of the machinery and affixing the CE-marking – see §81: comments on Article 2 (i).
The auctioneer who organises the sale by auction of such machinery offered for sale by consignors is be considered as a distributor and must therefore ensure that the machinery bears the CE marking, is accompanied by the EC Declaration of Conformity drawn up and signed by the manufacturer or his authorised representative and is accompanied by instructions – see §83: comments on Article 2 (i).
§76 Placing on the market of assemblies of machinery
Assemblies of machinery that are assembled in user’s premises by a person other than the user are considered to be placed on the market when the assembly operations have been completed and the assembly is handed over to the user for use – see §38: comments on Article 2 (a) – fourth indent, and §79: comments on Article 2 (i).
§77 Placing on the market of partly completed machinery
Partly completed machinery is considered to be placed on the market when it is made available to a manufacturer of complete machinery or of an assembly of machinery into which it is to be incorporated – see §46: comments on Article 2 (g).
Article 2
(i) ‘manufacturer’ means any natural or legal person who designs and/or manufactures machinery or partly completed machinery covered by this Directive and is responsible for the conformity of the machinery or the partly completed machinery with this Directive with a view to its being placed on the market, under his own name or trademark or for his own use. In the absence of a manufacturer as defined above, any natural or legal person who places on the market or puts into service machinery or partly completed machinery covered by this Directive shall be considered a manufacturer;
§78 The definition of ‘manufacturer’
The obligations created by the Machinery Directive relating to the conformity of machinery and partly completed machinery fall on the manufacturer or his authorised representative. These obligations are summarised in Article 5. The definition of ‘manufacturer’, together with the following definition of ‘authorised representative’, determine who shall fulfil these obligations. It is important to understand that the term manufacturer used here is not the same as used in general language, this is explained below in §79.
The term 'machinery' in the definition of ‘manufacturer’ is used in the broad sense, that is to say, the definition applies to the manufacturer of any of the products listed in Article 1, (a) to (f) and defined in Article 2 (a) to (f) – see §33: comments on the first paragraph of Article 2. The definition also applies to the manufacturer of partly completed machinery.
§79 Who is the manufacturer?
A manufacturer can be a natural or legal person, that is to say, an individual or a legal entity such as a company or association. The process of design and construction of machinery or partly completed machinery may involve several individuals or companies, but in this case one of them must take the responsibility, as the manufacturer, for the conformity of the machinery or partly completed machinery with the Directive. However, the term manufacturer in this Directive also can apply to other persons who have the responsibilities for conformity assessment and CE marking – see §81: comments on
Article 2 (i).
Since the essential health and safety requirements of the Directive mainly concern the design and construction of machinery, the person who is in the best position to fulfil these requirements is clearly the person who actually designs and constructs the machinery, or who at least controls the design and construction process. In some cases, the manufacturer may design and construct the machinery himself. In other cases, all or part of the design or the construction of the machinery may be carried out by other persons (suppliers or sub-contractors). However, the person who assumes the legal responsibility for the conformity of the machinery or the partly completed machinery with a view to its being placed on the market under his own name or trademark must ensure sufficient control over the work of his suppliers and sub-contractors and possess sufficient information to ensure that he is able to fulfil all his obligations under the Directive as set out in Article 5 – see §105: comments on Article 5 (3).
A person constituting an assembly of machinery is considered as the manufacturer of the assembly – see §38: comments on Article 2 (a). Usually, the elements constituting an assembly of machinery are supplied by different manufacturers, however one person must assume the responsibility for the conformity of the assembly as a whole. This responsibility can be assumed by the manufacturer of one or more of the constituent units, by a contractor or by the user. If a user constitutes an assembly of machinery for his own use he is considered as the manufacturer of the assembly – see §80 below.
§80 A person manufacturing machinery for his own use
A person who manufactures machinery for his own use is considered as a manufacturer and must fulfil all the obligations set out in Article 5. In that case, the machinery is not placed on the market, since it is not made available by the manufacturer to another person but used by the manufacturer himself. However, such machinery must comply with the Machinery Directive before it is put into service – see §86: comments on Article 2 (k). The same goes for a user constituting an assembly of machinery for his own use – see §79 above.
§81 Other persons who may be considered as manufacturers
The provision set out in the second sentence of the definition of ‘manufacturer’ is intended to deal with the situation that arises for certain machinery imported into the EU. If a machinery manufacturer established outside the EU takes the decision to place his products on the market in the EU, he is able to fulfil his obligations under the Machinery Directive himself or mandate an authorised representative to perform all or part of these obligations on his behalf – see §84 and §85: comments on Article 2 (j). In this case a person purchasing such CE marked machinery from outside the EU does not take on “the manufacturers” duties. On the other hand, the decision to import non-CE marked machinery into the EU may be taken by an importer, distributor or user. In some cases, the machinery may be ordered from an intermediary such as an export company. In other cases, a person may purchase the machinery outside the EU and bring it into the EU himself, order machinery via the Internet, or purchase machinery in a free zone (such as an auction site) with a view to its distribution or use in the EU.
The person placing such machinery on the market in the EU may be able to arrange for the “original manufacturer” to fulfil the obligations according to the Directive, and have the item CE marked. However, if that is not the case, the person placing the machinery on the market in the EU must fulfil these obligations himself. The same goes for a person importing machinery into the EU for his own use. In these cases, the person placing the machinery or partly completed machinery on the EU market or putting machinery into service in the EU is considered as the manufacturer and must therefore fulfil all of the obligations of manufacturer set out in Article 5.
This entails that the person placing the machinery on the market must have the means to satisfy these obligations, which include ensuring that the machinery satisfies the relevant essential health and safety requirements, ensuring that the technical file is available, providing the instructions, carrying out the appropriate conformity assessment procedure, drawing up and signing the EC Declaration of Conformity of the machinery and affixing the CE-marking – see §103 to §105: comments on Article 5.
It should be noted that the provision set out in the second sentence of the definition given in Article 2 (i) cannot be invoked by a manufacturer in the EU or by a manufacturer outside the EU who takes the initiative to place machinery on the EU market, in order to avoid their obligations under the Machinery Directive.
Another case where the duties of a manufacturer rest with a person/company other than who actually designed and made the machine, is where it is marketed and supplied under the distributors name or “brand”. This is a common situation with power tools and appliances sold in a number of chain stores and outlets marketed under a “brand” name owned by the store.
The flow chart below illustrates the various economic operators who can take on the duties of the manufacturer of machinery.
§82 Machinery modified before it is first put into service
In some cases, machinery is sold to an importer or a distributor who then modifies the machinery at the request of a customer before the machinery is put into service for the first time. If the modifications were foreseen or agreed by the manufacturer and covered by the manufacturer’s risk assessment, technical documentation and EC Declaration of Conformity, the original manufacturer’s CE marking remains valid. On the other hand, if the modification is substantial (for example, a change of function and/or performance of the machinery) and not foreseen or agreed by the manufacturer, the original manufacturer’s CE-marking becomes invalid and has to be renewed – see §72: comments on Article 2 (h). The modifier is then considered as the manufacturer and must fulfil all the obligations set out in Article 5 (1).
§83 Distributors
Regulation (EC) No 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products defines ‘distributor’ as “any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market”[20]. The Machinery Directive does not include explicit obligations for distributors of Machinery, unless the distributor is the authorised representative of the manufacturer or is the person placing the machinery on the market – see §81 above.
The role of distributors of machinery was clarified by a judgement of the European Court of Justice[21]. The Court judged that national provisions may require distributors to ensure that, before machinery is delivered to the user, it:
- bears the CE marking,
- is accompanied by the EC Declaration of Conformity drawn up and signed by the manufacturer or his authorised representative, translated into one of the official languages of the Member State in which the machinery is placed on the market,
- is accompanied by instructions in the official language or languages of the Member State concerned.
If the manufacturer has not provided original instructions in that or those languages, a distributor who brings the machinery into the language area in question must provide a translation – see §257: comments on section 1.7.4.1 of Annex I. If the Distributor installs the item or has the opportunity to see it in its working configuration, for example if they supply and install industrial equipment, they should be aware of any obvious defect such as missing guards or interlocks that are required to meet the essential health and safety requirements of the Directive. In such cases they should seek to correct the noncompliance with the manufacturer.
A distributor is generally expected to exercise due care with respect to the machinery he supplies, to be aware of the regulations to which it is subject and to refrain from supplying machinery which evidently fails to comply with the requirements of the Machinery Directive. However, the distributor cannot be required to verify himself the conformity of the machinery with the essential health and safety requirements of the Machinery Directive.
In case of doubt about the conformity of machinery, the distributor is expected to cooperate with the market surveillance authorities, for example, by assisting them in establishing contact with the manufacturer or his authorised representative and in obtaining from the latter the necessary information such as the relevant elements of the technical file – see §98: comments on Article 4.
With respect to specific obligations of distributors of chains, ropes and webbing – see §44: comments on Article 2 (e) and §357: comments on section 4.3.1 of Annex I.
Article 2
(j) ‘authorised representative’ means any natural or legal person established in the Community who has received a written mandate from the manufacturer to perform on his behalf all or part of the obligations and formalities connected with this Directive;
§84 The possibility to appoint an authorised representative
The obligations relating to the placing on the market and putting into service of machinery and the placing on the market of partly completed machinery fall on the manufacturer or his authorised representative. The nomination of an authorised representative in the EU is a solution available to manufacturers of machinery or partly completed machinery, whether established within or outside the EU, in order to facilitate the accomplishment of their obligations under the Directive. The authorised representative must have a written mandate from the manufacturer that specifies explicitly which of the obligations set out in Article 5 are entrusted to him. The authorised representative is thus different from a commercial agent or distributor.
An authorised representative can be a legal or natural person, that is to say, an individual or a legal entity such as a company or association. He must be established in the EU, in other words, he must have an address in the territory of one of the Member States.
The manufacturer must ensure that his authorised representative is given the means necessary to accomplish all of the obligations that are conferred on him. This is particularly important if the authorised representative is given the task of carrying out the conformity assessment of the machinery – see §105: comments on Article 5 (3).
It is not an obligation for a manufacturer established outside the EU to nominate an authorised representative: such a manufacturer can accomplish all of his obligations directly. However, whether or not such a manufacturer appoints an authorised representative, he must always indicate in the EC Declaration of Conformity or the Declaration of Incorporation the name and address of the person established in the EU who is authorised to compile the technical file or the relevant technical documentation – see §383: comments on Annex II 1 A (2), and §385: comments on Annex II 1 B (2). This duty is limited to putting together the technical information as supplied to this person by the manufacturer and to liaise and facilitate the supply of it to the Market Surveillance Authority who has requested to see the relevant parts of the technical file. They have no technical responsibility for the content of the technical file or have other compliance duties. Thus this person is not to be confused with an authorised representative.
It should also be noted that if the manufacturer has nominated an authorised representative for any of the obligations set out in Article 5, the EC Declaration of Conformity of the machinery or the Declaration of Incorporation of partly completed machinery must include the name and address of both the manufacturer and of his authorised representative – see §383: comments on Annex II 1 A (1), §385: comments on Annex II 1 B (1).
§85 The tasks of an authorised representative
A manufacturer can give a mandate to an authorised representative to carry all or part of the obligations mentioned in Article 5.
In the case of machinery, the tasks given by the manufacturer to the authorised representative may therefore include ensuring that the machinery satisfies the relevant essential health and safety requirements, ensuring that the technical file is available, providing the instructions, carrying out the appropriate conformity assessment procedure, drawing up and signing the EC Declaration of Conformity of the machinery and affixing the CE-marking – see §103 to §105: comments on Article 5.
In the case of partly completed machinery, the authorised representative of the manufacturer may be mandated to compile the relevant technical documentation, to prepare and provide the assembly instructions and to draw up and sign the Declaration of Incorporation of partly completed machinery – see §131: comments on Article 13.
Article 2
(k) ‘putting into service’ means the first use, for its intended purpose, in the Community, of machinery covered by this Directive;
§86 The definition of ‘putting into service’
The Machinery Directive applies to machinery when it is placed on the market and/or put into service. Machinery that is placed on the market in the EU is put into service when it is used in the EU for the first time. This applies to new machines that are completed and tested at the users site (may be referred to as ‘in-situ’ manufacturing), including both machines the user has built himself or have been built for him by another. Existing machinery originally first put into service outside the EU and moved by the user to his own site in the EU is also subject to the Machinery Directive as it is now being put into service for the first time in the EU. However, ‘putting into service’ does not apply to existing machinery (which was originally been put into service or placed on the market in the EU) that has had modifications carried out, unless they are so extensive that the machine is considered as new – see §72: comments on Article 2 (h). In such cases, the obligations of the manufacturer with respect to the placing on the market and the putting into service of the machinery are the same.
In the case of machinery manufactured by a person for his own use or an assembly of machinery constituted by the user (that is not placed on the market), the Machinery Directive applies when the machinery or assembly of machinery is first put into service. In other words, such machinery must comply with all the provisions of the Directive before it is first used for its intended purpose in the EU. The machinery may need to be tested as part of the installation and commissioning process for a short and limited period under the full control of the manufacturer, which includes the control of the persons involved in the testing. This process may then result in further modifications being required prior to CE marking and the issuing of the Declaration of Conformity. Only then it can be “cleared” for use or production and handed over to the user. This testing process must not be used for production as a way of getting around the legislation. This testing is considered to be part of the manufacturing process and not being put into service. However, during this period, full compliance must be fulfilled with the requirements of the national legislation that implements Directive 2009/104/EC concerning the minimum health and safety requirements for the use of work equipment by workers at work.
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Article 2
(l) ‘harmonised standard’ means a non-binding technical specification adopted by a standardisation body, namely the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (CENELEC) or the European Telecommunications Standards Institute (ETSI), on the basis of a remit issued by the Commission in accordance with the procedures laid down in Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (1).
(1) OJ L 204, 21.7.1998, p. 37. Directive as last amended by the 2003 Act of Accession.
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§87 The definition of ‘harmonised standard’
Harmonised standards are essential tools for applying the Machinery Directive. Their application is not mandatory. However, when the references of harmonised standards are published in the Official Journal of the European Union, application of their specifications confers a presumption of conformity with the essential health and safety requirements they cover – see §110: comments on Article 7 (2).
Furthermore, harmonised standards provide a good indication of the state of the art that must be taken into account when applying the essential health and safety requirements set out in Annex I – see §162: comments on General Principle 3 of Annex I.
Although the definition of ‘harmonised standards’ refers to the three European Standardisation Organisations (ESOs), in practice, only two ESOs, CEN and CENELEC, are involved in the development of standards supporting the Machinery Directive – see §112: comments on Article 7 (2).
The remit issued by the Commission mentioned in the definition is generally referred to as a mandate. On 19th December 2006, the Commission issued the mandate M/396 to CEN and CENELEC requesting the ESOs to review the existing body of harmonised standards for machinery in light of Directive 2006/42/EC and to develop the necessary new standards[22].
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Article 237
(m) ‘essential health and safety requirements’ means mandatory provisions relating to the design and construction of the products subject to this Directive to ensure a high level of protection of the health and safety of persons and, where appropriate, of domestic animals and property and, where applicable, of the environment.
The essential health and safety requirements are set out in Annex I. Essential health and safety requirements for the protection of the environment are applicable only to the machinery referred to in section 2.4 of that Annex.
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§88 Essential health and safety requirements
Machinery subject to the Machinery Directive must fulfil the relevant essential health and safety requirements set out in Annex I. The essential health and safety requirements are to be applied in light of the General principles set out in introduction to Annex I – see §157 to §163: comments on the General Principles of Annex I.
The essential health and safety requirements set out in Annex I may be supported by European harmonised standards – see §110 to §114: comments on Article 7 (2) and (3).
Most of the essential health and safety requirements concern primarily the protection of the health and safety of persons, including operators and other exposed persons – see §166: comments on section 1.1.1 of Annex I. They also concern the protection of domestic animals, including pets and livestock, insofar as such animals are liable to be exposed to the hazards generated by the machinery. There are no specific essential health and safety requirements relating to the protection of property, however certain of the essential requirements deal with hazards that are liable to damage property, such as, for example, the fire and explosion hazards.
The only essential health and safety requirements of the Machinery Directive that concern the protection of the environment are those set out in section 2.4 of Annex I which apply to machinery for pesticide application – see §282 to §290: comments on section 2.4 of Annex I. Other categories of machinery may be subject to environmental protection requirements set out in other specific Directives – see §92: comments on Article 3.
Article 3
Specific Directives
Where, for machinery, the hazards referred to in Annex I are wholly or partly covered more specifically by other Community Directives, this Directive shall not apply, or shall cease to apply, to that machinery in respect of such hazards from the date of implementation of those other Directives.
37 Article 2 (m) was introduced by Directive 2009/127/EC of the European Parliament and of the Council of
21 October 2009 amending Directive 2006/42/EC with regard to machinery for pesticide application. OJ L310, 25.11.2009, p. 29.
§89 The Machinery Directive and other internal market legislation
According to Article 3, for products in the scope of the Machinery Directive, the provisions of the Machinery Directive may be totally or partially superseded by other EU legislation (Directives or Regulations) that cover all or certain of the hazards concerned more specifically.
This specific legislation may be comprehensive health and safety Directives covering all of the machinery hazards for the products in their scope. According to Article 3, these Directives are to be applied instead of the Machinery Directive for the products in their scope – see §90 below.
In other cases, the overlap between the specific Directives and the Machinery Directive is limited to one or a few hazards. According to Article 3, in these cases the relevant requirements of the specific Directive are to be applied instead of the corresponding essential health and safety requirements of the Machinery Directive – see §91 below.
Besides the specific Directives referred to in Article 3, other EU Directives may apply in a complementary way to machinery in the scope of the Machinery Directive for aspects not covered by the Machinery Directive, such as electromagnetic compatibility or the protection of the environment – see §92 below.
The other EU legislation referred to in the following paragraphs are Directives or Regulations for ensuring the free movement of goods through technical harmonisation based on Article 95 of the EC Treaty (now Article 114 of the TFEU). They do not include Directives based on Article 175 EC (now Article 192 of the TFEU) relating to the protection of the environment, or Directives based on Article 137 EC (now Article 153 of the TFEU) relating to the protection of workers' health and safety. For the relationship between the Machinery Directive and the Directives based on Article 137 EC (Article 153 TFEU) – see §140: comments on Article 15.
The Directives referred to in §90 to §92 may also be applicable to partly completed machinery referred to in Article 1 (g).
It should be noted that when more than one Directive is applicable to machinery, the conformity assessment procedure required by each Directive may be different. In that case, the conformity assessment to be carried out under each Directive concerns only the aspects that are covered more specifically by that Directive.
The CE-marking affixed on the machinery signifies that the machinery complies with all of the applicable EU legislation requiring the CE-marking – see §106: comments on Article 5 (4), and §141: comments on Article 16. Note that although partly completed machinery must not bear the CE mark under the Machinery Directive, it may bear the CE mark if it also comes under other relevant legislation such as ATEX – see §251: comments on Annex I 1.7.3 – third paragraph.
When, in addition to the Machinery Directive, one or more other Directives requiring an EC Declaration of Conformity are applicable to machinery, the manufacturer may draw up a single EC Declaration of Conformity for all of the Directives concerned, providing this Declaration contains all the information required by each Directive. This may not be possible in all cases, since certain Directives specify a particular format for the Declaration of Conformity. In any case, the EC Declaration of Conformity of the machinery must include a declaration that the machinery complies with the other applicable Directives – see §383: comments on Annex II 1 A (4).
§90 Specific EU legislation that apply instead of the Machinery Directive to machinery that is in their scope
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Directive 2014/35/EU38 (*) on electrical equipment designed for use within certain voltage limits
(Low Voltage Directive, LVD)
(*) replacing the previous
LVD 2006/95/EC39 from 20
April 2016
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The Low Voltage Directive is a comprehensive health and safety Directive, dealing with all risks, in accordance with Article 3, the MD is thus not applicable to machinery that is within the scope of the LVD.
However, Annex I section 1.5.1 Electricity supply brings in all the essential requirements of the LVD into the Machinery Directive and thus also the standards harmonized under the LVD.
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Directive 2009/48/EC40 on the safety of toys
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The Toys Directive is a comprehensive health and safety Directive, dealing more specifically than the MD with the hazards of machinery intended to be used as toys.
In accordance with Article 3, the MD is thus not applicable to machinery that is within the scope of the Toys Directive.
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Directive 89/686/EEC41 (*) on personal protective equipment
(PPED)
(*) a new Regulation (EU) 2016/425 on PPE was approved in 2016 and will be applicable from 21.04.201842
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The PPED is a comprehensive health and safety Directive, dealing more specifically than the MD with the hazards of machinery intended for use as PPE.
In accordance with Article 3, the MD is thus not applicable to machinery that is within the scope of the PPED.
It should be noted that products that are subject to the PPED may be fitted to machinery, such as, for example, rigid or flexible guides for personal fall arrest equipment.
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38 OJ L 96, 29.3.2014, p. 357. 39 OJ L 374, 27.12.2006. 40 OJ L 170, 30.6.2009 p. 1. 41 OJ L 399, 30.12.1989 p. 18. 42 OJ L 81,31.3.2016 p.51.
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Directive 93/42/EEC43(*) as amended by Directive
2007/47/EC44 on medical devices
(MDD)
(*) a new Regulation (EU) 2017/475 on medical devices was approved in 2017 and will be applicable from
26.05.2020
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The MDD is a comprehensive health and safety Directive, dealing more specifically than the MD with the hazards of machinery intended for medical use.
In accordance with Article 3, the MD is thus not applicable to machinery that is within the scope of the MDD.
It should be noted that Article 3 of the MDD as amended makes any essential health and safety requirements of the MD that are relevant and that are more specific than the ones included in the MDD applicable to medical devices that are machinery, while all the other obligations relating to the placing on the market of such devices, including the conformity assessment procedure and the risk assessment, are set by the MDD only.
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Directive 2014/33/EU45 (*) on lifts
(LD)
(*) replacing the previous LD
95/16/EC46 from 20 April
2016
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The LD is a comprehensive health and safety Directive, dealing more specifically than the MD with the hazards of machinery intended for use as a lift and those of safety components for lifts.
In accordance with Article 3, the MD is not thus applicable to the lifts or safety components that are within the scope of the LD.
It should be noted that section 1.1 of Annex I of the LD makes any relevant essential health and safety requirements of the MD, that are not included in Annex I of the LD, applicable to lifts, while all the other obligations relating to the placing on the market of such lifts, including the conformity assessment procedure, are set by the LD only.
The MD applies to lifts that are excluded from the scope of the LD, unless they are also excluded from the scope of the MD – see §47 to §70: comments on Articles 1 (2), and §151: comments on Article 24.
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43 OJ L 169, 12.7.1993 p. 1. 44 OJ L 247, 21.9.2007 p. 21. 45 OJ L 96, 29.3.2014, p. 251. 46
OJ L 213, 7.9.1995, p. 1.
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Directive 2000/9/EC47 (*) on cableway installations designed to carry persons
(*) a new Regulation (EU) 2016/424 on Cableways was approved in 2016 and should be applicable in 2018
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The Cableways Directive is a comprehensive health and safety Directive, dealing more specifically than the MD with the hazards of machinery intended for use as cableways designed to carry persons.
In accordance with Article 3, the MD is thus not applicable to cableways designed to carry persons that are within the scope of the Cableways Directive.
The MD applies to certain cableways that are outside or excluded from the scope of the Cableways Directive such as, for example, cableways for the transport of goods only and cableways for agricultural, mining or industrial purposes.
Other installations that are excluded from the scope of the Cableways Directive are also excluded from the scope of the MD, for example, as means of transport on water or on rail networks or as specific equipment for use in fairgrounds or amusement parks – see §49 and §57: comments on Article 1
(2).
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Regulation (EU) No
167/201348 on agricultural and forestry vehicles
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This Regulation covers all identified risks including those previously covered by the Machinery Directive, for agricultural and forestry tractors, and so a complete exclusion from the Machinery Directive could be made. To do this it modified Article 1(2)(e) of the Machinery Directive, removing the reference to the exclusion being only for the risks covered by that Directive. Such tractors supplied under Regulation 167/2013 from 1 January 2016 are completely excluded from the Machinery Directive.
However, there is a two-year transition period where tractors supplied under Directive 2003/37/EC can still be supplied up to 31 December 2017, and are thus also in scope of the Machinery Directive 2006/42/EC.
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47 OJ L 106, 3.5.2000, p. 21. 48
OJ L 60, 2.3.2013, p. 1.
§91 Specific EU legislation that may apply to machinery instead of the
Machinery Directive for specific hazards
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Directive 2014/34/EU49 (*) on equipment and protective systems intended
for use in potentially explosive atmospheres (ATEX Directive)
(*) replacing the previous ATEX Directive 94/9/EC50 from 20 April 2016
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In accordance with Article 3, the ATEX Directive applies, for the explosion hazard, to machinery intended for use in potentially explosive atmospheres.
The reference to “the specific Community Directives” in the second paragraph of section 1.5.7 of Annex I of the MD is to be understood as a reference to the ATEX Directive.
It should be noted that the ATEX Directive does not apply to areas within machinery where a potentially explosive atmosphere may exist or to explosion hazards that are not due to atmospheric conditions51.
The risk of explosion posed by or within the machinery itself or by gases, liquids, dust, vapours or other substances produced or used by the machinery are covered by the MD - see §228: comments on section 1.5.7 of Annex I.
A machinery manufacturer may incorporate ATEX equipment, protective systems or components that have already been placed on the market in order to prevent the risk of explosion in areas within the machinery. In that case, the EC Declaration of Conformity of the machinery should not refer to the ATEX Directive but the EC Declarations of conformity of the ATEX equipment, systems or components incorporated into the machinery must be included in the machinery manufacturer’s technical file – see §392: comments on Annex VII A 1 (a).
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Directive 84/500/EEC52 on ceramic articles to come into contact with foodstuffs
Regulation (EC) No 1935/200453 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC Directive 2002/72/EC54 on plastic materials and articles intended to come into contact with foodstuffs
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In accordance with Article 3, the EU provisions on materials and articles intended to come into contact with food apply to the relevant parts of foodstuffs machinery.
The reference in section 2.1.1 (a) of Annex I of the Machinery
Directive to “the relevant Directives” is to be understood as a reference to Directive 84/500/EEC, Regulation (EC) No 1935/2004 and Directive 2002/72/EC.
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49 OJ L 96, 29.3.2014, p. 309. 50 OJ L 100, 19.4.1994, p. 1. 51 See the Guidelines on the application of Directive 2014/34/EU (ATEX Guidelines). 52 OJ L 277, 20.10.1984 p. 12.
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Directive 2014/29/EU55 (*) on simple pressure vessels
(SPVD)
(*) replacing the previous
SPVD 2009/105/EC56 from 20
April 2016
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In accordance with Article 3, the SPVD applies, for the pressure hazards, to simple pressure vessels manufactured in series within its scope that are incorporated into or connected to machinery.
It should be noted that the MD covers the risk of break-up during operation – see §207: comments on section 1.3.2 of Annex I.
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Directive 2009/142/EC57 (*) on appliances burning gaseous fuels
(Gas Appliances Directive, GAD)
(*) a new Regulation (EU) 2016/426 on gas appliances was approved in 2016 and will be applicable from
21.04.201858
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The GAD applies to appliances burning gaseous fuels used for cooking, heating, hot water production, refrigeration, lighting or washing, including forced draught burners, and to fittings for such appliances.
In accordance with Article 3, the GAD also applies, for the hazards that it covers, to gas appliances within its scope that are incorporated into machinery.
Appliances specifically designed for use in industrial processes carried out on industrial premises are excluded from the GAD. Such appliances, and other gas appliances excluded from the scope of the GAD, are subject to the MD if they are in its scope or are incorporated into machinery.
The MD also applies to gas appliances in the scope of the GAD that have powered moving parts, for hazards that are not covered by the GAD.
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Directive 2014/68/EU59 (*) on pressure equipment
(PED)
(*) replacing the previous PED
97/23/EC60 from 19 July 2016
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In accordance with Article 3, the PED is applicable, for the pressure hazards, to pressure equipment within its scope that is incorporated into or connected to machinery. If pressure equipment that has already been placed on the market is incorporated into machinery, the machinery manufacturer’s technical file must include the EC Declaration of Conformity of that pressure equipment to the PED – see §392: comments on Annex VII A 1 (a).
Pressure equipment classified as no higher than category 1 that is incorporated into machinery in the scope of the MD is excluded from the scope of the PED. The MD is thus fully applicable to such equipment.
It should be noted that the MD covers the risk of break-up during operation – see §207: comments on section 1.3.2 of Annex I.
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53 OJ L 338, 13.11.2004 p. 4. 54 OJ L 220, 15.08.2002 p. 18. 55 OJ L 96, 29.3.2014, p. 45. 56 OJ L 264, 8.10.2009, p. 12. 57 OJ L 330, 16.12.2009, p. 10. 58 OJ L 81, 31.3.2016, p.99 59 OJ L 189, 27.6.2014, p. 164.
§92 EU legislation that may apply to machinery, in addition to the Machinery Directive, for hazards they cover more specifically than the Machinery Directive
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Regulation (EU) No 305/201161 (*) on construction products
(CPR)
(*) replaced the previous CPD
89/106/EEC62 from 1 July
2013
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The CPR sets out requirements relating to the suitability of construction products for the construction works into which they are to be incorporated.
The CPR applies, in addition to the Machinery Directive, to machinery designed to be incorporated in a permanent manner in construction works, such as, for example, powered gates, doors, windows, shutters and blinds, ventilation and air-conditioning systems.
It should be noted that application of the CPR is possible only when a harmonised technical specification is available.
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Regulation (EU) 2016/162863 (*) on requirements relating to gaseous and particulate pollutant emission limits
(NRMMD)
(*) amending and repealing
Directive 97/68/EC64
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The NRMMD Regulation sets out type-approval requirements and emission limits for the gaseous and particulate emissions of internal combustion engines to be installed in the non-road mobile machinery that is within its scope.
Engines installed in non-road mobile machinery must bear the markings referred to in Article 32 to Regulation (EU) 2016/1628 and further specified in its Implementing Regulation (EU) 2017/656, but those Regulations shall not be mentioned in the EC Declaration of Conformity of the machinery.
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Directive 2014/53/EU65 (*) on radio equipment
(RED)
(*) replacing the previous
R&TTED 1999/5/EC66 from 13
June 2016
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The requirements of the RED with respect to the use of the radio frequency spectrum apply to radio equipment within its scope that is incorporated into machinery, such as, for example, certain remote control devices.
It should be noted that the safety of remote control systems for machinery is subject to the MD – see §184: comments on section 1.2.1 of Annex I.
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60 OJ L 181, 9.7.1997, p. 1. 61 OJ L 88, 4.4.2011, p. 5.
- OJ L 40, 11.2.1989, p. 12.
- OJ L 252, 16.9.2016, p.53 64 OJ L 59, 27.2.1998, p. 1. 65 OJ L 153, 22.5.2014, p. 62. 66 OJ L 91, 7.4.1999, p. 10.
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Directive 2000/14/EC67 as amended by Directive
2005/88/EC68 on the noise emission in the environment by equipment for use outdoors
(OND)
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The OND sets out environmental noise emission requirements for machinery intended for use outdoors within its scope.69
It should be noted that the last paragraph of section 1.7.4.2 (u) of Annex I of the MD refers to other Community Directives that address noise. Where machinery is within the scope of the OND, the MD provisions concerning sound power levels do not apply – see §229 and §230: comments on section 1.5.8, and §273: comments on section 1.7.4.2 (u) of Annex I.
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Directive 2011/65/EU70 (*) on the restriction of the use of certain hazardous substances in electrical and electronic equipment
(RoHS)
(*) replaced the previous
Directive 2002/95/EC71 from 3
January 2013
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The RoHS Directive sets out restrictions on the use of certain hazardous substances in the electrical and electronic equipment belonging to categories 1, 2, 3, 4, 5, 6, 7 and 10 as set out in Annex I A to Directive 2002/96/EC72 (WEEE).
Certain products belonging to these categories may also be in the scope of the Machinery Directive such as, for example, categories 1 – large household appliances that are not intended for domestic use, 6 – electrical and electronic tools, 7 – powered leisure and sports equipment and 10 – automatic dispensers.
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Directive 2014/30/EU73 (*) on electromagnetic compatibility
(EMCD)
(*) replacing the previous
EMCD 2004/108/EC from 20
April 2016
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The EMCD applies to machinery that contains electrical or electronic parts that may generate or be affected by electromagnetic disturbance. The EMCD covers aspects of electromagnetic compatibility related to the functioning of machinery74.
However, the MD covers the immunity of machinery with respect to safety-related electromagnetic disturbance, whether transmitted by radiation or by wire – see §184: comments on section 1.2.1, and §233: comments on section 1.5.11 of Annex I.
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67 OJ L 162, 3.7.2000, p. 1. 68 OJ L 344, 27.12.2005, p. 44. 69 See the Guidelines for the application of Directive 2000/14/EC. 70 OJ L 174, 1.7.2011, p. 88. 71 OJ L 37, 13.2.2003, p. 19. 72 OJ L 37, 13.2.2003, p. 24. 73 OJ L 96, 29.3.2014, p. 79. 74 See the Guide for the EMC Directive 2004/108/EC.
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Directive 20[23]09/125/EC75 (*) on eco-design requirements for energy-related products
(EuP Directive)
(*) replaced the previous
Directive 2005/32/EC from 20
November 2010
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The EuP Directive provides a framework for the adoption of eco-design requirements for industrial products.
The implementing measures adopted in the framework of the EuP Directive may apply to machinery or to equipment to be incorporated into machinery, such as, for example, pumps.
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Article 4
Market surveillance
1. Member States shall take all appropriate measures to ensure that machinery may be placed on the market and/or put into service only if it satisfies the relevant provisions of this Directive and does not endanger the health and safety of persons and, where appropriate, domestic animals or property and, where applicable, the environment, when properly installed and maintained and used for its intended purpose or under conditions which can reasonably be foreseen[24]. . . .
§93 Market surveillance
Article 4 sets out the obligation of the Member States to ensure that the provisions of the Machinery Directive for machinery and partly completed machinery are correctly applied and that machinery placed on the market and put into service is safe. This Article was changed by Directive 2009/127/EC which amended the Machinery Directive with regard to machinery for pesticide application. The main change was to add “does not endanger and, where applicable, the environment”, otherwise the application of this Article is not affected.
The term 'machinery' in Article 4 (1) is used in the broad sense to refer to the product categories referred to in Article 1 (1) (a) to (f) – see §33: comments on the first paragraph of Article 2.
Basic rules for market surveillance are set out in Chapter III of the Regulation (EC) No 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products.[25] The Regulation is directly applicable from 1st January 2010. Its provisions relating to market surveillance are complementary to those of the Machinery Directive, in other words, they apply when the Machinery Directive does not include specific provisions having the same objective[26].
The following comments relate both to the provisions of Article 4 of the Machinery Directive and to the complementary provisions included in Chapter III of the Regulation. The relevant provisions of the Regulation are summarised and references are made to the relevant Articles of the Regulation in footnotes, however readers should consult the full text of the Regulation.
The term ‘market surveillance’ designates the activities carried out and the measures taken by public authorities to ensure that the products subject to the Directive have been subject to the requisite conformity assessment procedures, that they comply with the applicable essential health and safety requirements and, for complete products, that they are safe.[27] Market surveillance is carried out when or after such products are placed on the market or put into service. Market surveillance is thereby distinguished from conformity assessment, which aims to ensure the conformity of products before they are placed on the market or put into service.
§94 Market surveillance of machinery
The market surveillance of machinery required by Article 4 (1) includes at least the following activities:
- checking that machinery that is placed on the market or put into service bears the
CE-marking and is accompanied by a correct EC Declaration of Conformity – see §103: comments on Articles 5 (1), §141: comments on Article 16, §383: comments on Annexes II 1 A, and §387: comments on Annex III;
- ensuring that machinery that is placed on the market or put into service has been subject to the appropriate conformity assessment procedure – see §127 to §130: comments on Article 12;
- checking that machinery that is placed on the market or put into service is accompanied by the necessary information, such as instructions – see §103: comments on Articles 5 (1), and §254 to §256: comments on section 1.7.4 of Annex I;
- where the machinery incorporates partly completed machinery, checking that the assembly instructions of the manufacturer of the partly completed machinery have been correctly followed by the manufacturer of the complete machinery or assembly of machinery;
- monitoring the conformity of machinery that is placed on the market or put into service to ensure that it complies with the essential health and safety requirements that are applicable and does not endanger the health and safety of persons and, where appropriate, domestic animals, property or the environment in the case of pesticides machinery – see §282: comments on EHSR 2.4 on
Annex I; §103: comments on Article 5 (1), and §160: comments on General principle 2 of Annex I;
- taking appropriate action to ensure that non-compliant products are brought into conformity or withdrawn from the market – see §122 to §126: comments on Articles 11, and §142, comments on Article 17.
The essential health and safety requirements of the Machinery Directive mainly concern the health and safety of persons, including operators and other exposed persons – see §166 and §167: comments on sections 1.1.1 (c) and (d) of Annex I. The essential health and safety requirements apply, also where appropriate, to the health and safety of domestic animals (the use of the word “domestic” has a wide definition and included animals bred for farming, and not just household pets). This may be relevant, for example, to machinery intended for use with, or liable to be in contact with farm animals, horses or pets. The essential health and safety requirements also apply, where appropriate, to the protection of property, for example, against the risks of fire or explosion – see §227 and §228: comments on sections 1.5.6 and 1.5.7 of Annex I.
Market surveillance can be carried out at any stage after the construction of the machinery is complete, as soon as the product concerned has been made available for distribution or use in the EU – see §73: comments on Article 2 (h). Machinery can be examined in the premises of manufacturers, importers, distributors, rental companies, in transit or at the external borders of the EU.
The conformity of machinery may also be checked at the user’s premises after it has been put into service, however, in that case, the market surveillance authorities must take care to distinguish the features of the machinery as it was supplied by the manufacturer from features that may result from modifications carried out by the user – see §382: comments on Annex II 1 A. This may be facilitated by examination of the relevant elements of the manufacturer’s technical file – see §392: comments on Annex VII A. The conformity of machinery manufactured by the user for his own use may also be checked after it has been put into service – see §86: comments on Article 2 (k).
If the non-conformity of machinery in use creates a risk for users, the national authorities in charge of occupational health and safety may require users to take the necessary measures to protect persons and, in case of serious risk, may forbid the use of the machinery. Such measures may be taken in the framework of national regulations implementing Directive 2009/104/EC on the use of work equipment – see §140: comments on Article 15. However, in such cases, the market surveillance authorities shall also take the necessary action on the basis of the Machinery Directive with respect to the manufacturer of the machinery concerned.
When assessing the conformity of machinery, the market surveillance authorities must take account of the state of the art including, where appropriate, the harmonised standards in force, at the time the machinery was placed on the market – see §161 and §162: comments on General Principle 3 of Annex I.
The market surveillance authorities must take into account the use of the machinery intended by the manufacturer and also reasonably foreseeable misuse – see §171 and §172: comments on sections 1.1.1 (h) and (i) of Annex I.
Article 4 (continued)
. . .
2. Member States shall take all appropriate measures to ensure that partly completed machinery can be placed on the market only if it satisfies the relevant provisions of this Directive.
. . .
§95 Market surveillance of partly completed machinery
Article 4 (2) requires Member States to carry out market surveillance of partly completed machinery.
Market surveillance of partly completed machinery can be carried out before the partly completed machinery has been incorporated into the final machinery or assembly of machinery. The market surveillance authorities may also carry out checks on machinery or assemblies of machinery into which partly completed machinery has been incorporated. In that case, the market surveillance of the partly completed machinery is an aspect of the market surveillance of the final machinery.
If a non-conformity is detected in the partly completed machinery after it has been incorporated, the market surveillance authorities can check in the technical file for the final machinery whether the Declaration of Incorporation for the partly completed machinery states that the essential health and safety requirement concerned has been applied and fulfilled – see §384: comments on Annex II 1 B. In that case, the market surveillance authorities should address the manufacturer of the partly completed machinery.
Market surveillance of partly completed machinery comprises the following activities:
- ensuring that partly completed machinery that has been placed on the market has been subject to the appropriate procedure – see §131: comments on Article 13;
- checking that partly completed machinery that has been placed on the market is accompanied by a correct Declaration of Incorporation. In particular, ensuring that the Declaration of Incorporation includes the declaration as to which essential health and safety requirements have been applied and fulfilled – see §131: comments on Article 13, and §384: comments on Annex II. 1 B;
- checking that the manufacturer’s assembly instructions have drawn up so as to enable the manufacturer of the complete machinery to assemble the partly completed machinery correctly – see §131: comments on Article 13, and §390: comments on Annex VI;
- monitoring the conformity of the partly completed machinery that has been placed on the market with the essential health and safety requirements that the manufacturer states have been applied and fulfilled – see §385: comments on Annex II B 4. The monitoring of partly completed machinery can be facilitated by referring to the relevant technical documentation – see §394: comments on Annex VII B;
- taking appropriate measures to deal with partly completed machinery that fails to comply with any of the provisions referred to in (a) to (d) above. Although the Machinery Directive does not specify the measures to be taken, it is clear that the market surveillance authorities must require the manufacturer of partly completed machinery to bring his product into conformity with the provisions referred to in (a) to (d) above and, failing that, to ensure that the product is withdrawn from the market.
Article 4 (continued)
. . .
- Member States shall institute or appoint the competent authorities to monitor the conformity of machinery and partly completed machinery with the provisions set out in paragraphs 1 and 2.
- Member States shall define the tasks, organisation and powers of the competent authorities referred to in paragraph 3 and shall notify the Commission and other Member States thereof and also of any subsequent amendment.
§96 Market surveillance authorities
The term ‘competent authorities’ designates the authority or authorities of each Member State responsible for carrying out market surveillance on its territory[28]. Articles 4 (3) and 4 (4) require the Member States to designate the authorities that are responsible for carrying out market surveillance and to define their tasks, organisation and powers. The Member States are free to determine how their market surveillance is organised, however the market surveillance system must fulfil certain criteria:
- The market surveillance authorities shall carry out their duties independently, impartially and without bias[29].
- The Member States must provide the market surveillance authorities with adequate resources in terms of staff and budget to carry out their tasks.
- The legal powers to be given to the market surveillance authorities shall include the power to require economic operators to make available the necessary documentation and information and, where justified, to enter the premises of economic operators and take the necessary representative samples of products[30].
- The Member States must ensure that the powers given to the market surveillance authorities are exercised in accordance with the principle of proportionality[31].
- The Member states must take the necessary measures to ensure that the public is aware of the existence, responsibilities and identity of the national market surveillance authorities, as well as how they may be contacted[32].
- The market surveillance system must be able to cover the whole range of products subject to the Machinery Directive, including machinery for professional use and machinery intended for use by consumers[33]. In some Member States, a single authority may cover the whole range of products. In other Member States, market surveillance for the Machinery Directive may be shared between, for example, the authority in charge of consumer protection and the authority responsible for occupational health and safety.
- If more than one authority is involved, the Member State must make arrangements to ensure the necessary coordination and communication between them[34].
- The market surveillance authorities must have the facilities to carry out the necessary technical inspection and tests or, at least, they must have access to the necessary facilities as required[35]. The public authorities responsible for market surveillance may entrust certain specific tasks, such as testing or technical inspection of machinery, to competent test or inspection bodies, including private bodies. However, the public market surveillance authorities remain responsible for all market surveillance decisions and measures taken on the basis of tests or inspections carried out on their behalf by such bodies.
§97 The market surveillance system
The market surveillance system must include:
- a procedure for dealing with complaints about non-compliant machinery;
- a system for monitoring and acting on reports and data relating to accidents and damage to health due to machinery;
- surveys of particular categories of machinery and inspection or testing of samples;
- adequate means to verify that corrective actions have been effectively carried
out;
- means to follow up scientific and technical knowledge concerning health and safety issues relating to machinery.[36]
Obviously, the market surveillance authorities cannot examine all of the products placed on the market, but the level of monitoring of products on the market must be sufficient to ensure that market surveillance activity is perceived by the stakeholders concerned and has a significant impact on the behaviour of the economic operators.
The market surveillance authorities shall take appropriate action when complaints or reports on accidents, incidents or damage to health due to machinery indicate that the machinery concerned does not comply with the essential health and safety requirements of the Machinery Directive.
The market surveillance authorities shall follow up decisions made by the Commission according to the safeguard clause procedure – see §122 to §126: comments on Article 11. The market surveillance authorities shall also follow up information on unsafe products notified under the RAPEX system set up under the General Product Safety Directive[37].
In addition to such reactive action, market surveillance activity shall be organised on the basis of periodic market surveillance programmes which must be regularly reviewed and updated in order to improve their effectiveness. The market surveillance programme for machinery can either be included in a general market surveillance programme or be subject to a sector-specific programme. The market surveillance programmes must be communicated to the other Member States and to the Commission and made known publicly, including by means of electronic communications. The first such communication shall take place by 1st January 2010. Market surveillance programmes must be reviewed at least every fourth year and the results of the review shall be communicated to the other Member States and to the Commission and made available to the public[38].
In order to be most effective, market surveillance activity should be based on risk assessment. Particular attention should be given to product areas where there is evidence of poor application of the provisions of the Directive or where, despite application of the Directive, the rate of accidents or damage to health due to the use of machinery remains high.
In order to optimise the use of resources, cooperation and coordination between the market surveillance authorities of the Member States is necessary – see §144: comments on Article 19. The Regulation setting out the requirements for accreditation and market surveillance relating to the marketing of products foresees specific measures to improve such cooperation as well as measures to ensure appropriate cooperation with the competent authorities of third countries[39].
§98 The tools for market surveillance
The European Commission has introduced the Information and Communication System for Market Surveillance (ICSMS)[40] which is a databased system that implements Article 23 of Regulation (EC) No 765/2008, as a key tool for market surveillance authorities.
The ICSMS system’s internal section is confidential and should be used to record the results of market surveillance. In this sense, it provides a tool:
- to enable market surveillance authorities to exchange information on products being examined and thus help stop duplication of effort;
- to facilitate the cooperation between market surveillance authorities to bring defective products into compliance; and
- to provide a means to help plan and manage market surveillance campaigns and projects.
The database should be filled in when the investigation of a machine has started so other authorities know of this work and can stop any duplication of effort and to establish cooperation where it is beneficial. As the information in the investigation is obtained, the ICSMS database should be added to. Facilities exist in ICSMS to transfer this information to the necessary forms for both RAPEX and Safeguard Notifications if these are required.
The following sections explain the steps market surveillance can proceed and the information that should be available to assist this process.
The CE marking and the EC Declaration of Conformity
The CE marking affixed to the machinery and the manufacturer’s EC Declaration of Conformity that shall accompany the machinery are the first elements that can be checked by the market surveillance authorities – see §141: comments on Articles 16, §385: comments on Annex II 1 A, and §387: comments on Annex III.
In particular, the EC Declaration of Conformity provides essential information to enable the market surveillance authorities to carry out the necessary checks:
- the identity of manufacturer of the machinery and of his authorised
representative, where appropriate;
- the person authorised to compile the technical file;
- the conformity assessment procedure that has been followed and the identity of the Notified Body involved, where appropriate;
- the other Directives that have been applied to cover certain hazards more specifically – see §89 to §92: comments on Article 3;
- the harmonised standards or other technical specifications that have been applied, where appropriate.
In order to benefit from the presumption of conformity conferred by the application of harmonised standards, manufacturers must indicate the references of the harmonised standard(s) applied in the EC Declaration of Conformity. However, it should be recalled that the application of harmonised standards remains voluntary – see §110 and §111: comments on Articles 7 (2), §114: comments on Article 7 (3) and §385: comments on Annex II 1 A.
In the case of machinery belonging to one of the categories listed in Annex IV where the manufacturer has followed the procedure for assessment of conformity with internal checks on the manufacture of machinery according to Annex VIII, the manufacturer must indicate the reference(s) of the harmonised standard(s) applied in the EC Declaration of Conformity, since the application of harmonised standards that cover all of the EHSRs applicable to the machinery is a condition for using that conformity assessment procedure – see §129: comments on Article 12 (3).
Where the reference of a harmonised standard is indicated in the EC Declaration of Conformity, the market surveillance authorities are entitled to consider that the manufacturer has applied the specifications of the standard in full. If the manufacturer has not applied all of the specifications of a harmonised standard, he may still indicate the reference of the standard in the EC Declaration of Conformity, but, in that case, he must indicate which specifications of the standard he has or has not applied. The instructions
Examination of the instructions that must accompany the machinery may also provide important information for the purposes of market surveillance. The instructions must be provided in the official language or languages of the country of use – see §256: comments on section 1.7.4 of Annex I.
In particular, the instructions must specify the intended use of the machinery, which must be taken into account in the course of any investigation of the conformity of the machinery – see §171: comments on section 1.1.1 (h) of Annex I. The technical file or the relevant technical documentation
If the market surveillance authorities have a doubt as the conformity of machinery with the essential health and safety requirements, they may request communication of all or part of the manufacturer’s technical file – see §393: comments on Annex VII A 2 and 3. In the case of partly completed machinery, the market surveillance authorities may request communication of the manufacturer’s relevant technical documentation – see §394: comments on Annex VII B. Such a request can be made at any stage of the market surveillance process.
These provisions have a dual purpose: on the one hand, providing the relevant elements of the technical file or of the relevant technical documentation enables a manufacturer to explain the measures he has taken to deal with the risks associated with the machinery in order to comply with the applicable essential health and safety requirements. On the other hand, the examination of these documents helps the market surveillance authorities to complete their investigation and either dispel or confirm their doubts about the conformity of the machinery concerned. However, it is not necessary for the market surveillance authorities to request these documents if they consider that they already have enough information on which to base their decision.
The request for communication of the technical file or of the relevant technical documentation should indicate the nature of the doubt about the conformity of the machinery concerned and the parts or aspects of the machinery that are subject to investigation. Only the elements of the technical file or the relevant technical documentation that are necessary for the investigation should be requested, so as not to constitute a disproportionate burden for the manufacturer.
Failure to present the technical file for machinery, or the relevant technical documentation for partly completed machinery, in response to such a duly reasoned request may constitute grounds for doubting the conformity of the machinery or the partly completed machinery – see §393: comments on Annex VII A 3, and §394: comments on Annex VII B (b). In other words, if the manufacturer fails to respond to a duly reasoned request to supply the relevant elements of his technical file or technical documentation, the market surveillance authorities are entitled to decide what action to take on the basis of whatever other evidence is available to them.
§99 Documents relating to Annex IV machinery
When machinery belonging to one of the categories listed in Annex IV has been subject to one of the conformity assessment procedures involving a Notified Body, in addition to the requests for documentation mentioned in the preceding paragraph, the market surveillance authorities have the possibility to obtain certain documents from the Notified Body concerned.
EC type-examination
For machinery subject to the EC type-examination procedure set out in Annex IX, the market surveillance authorities may, on request, obtain a copy of the relevant EC typeexamination certificate. This enables the authorities, from any Member State, to check that a certificate has really been issued for the machinery concerned. On reasoned request, the market surveillance authorities may obtain a copy of the technical file and the results of the examinations carried out by the Notified Body – see §399: comments on Annex IX 7.
Such requests may be addressed by the market surveillance authority directly to the Notified Body that carried out the EC type-examination. The Notified Body should respond to the national market surveillance authority making the request. In case of difficulties, for example, with respect to language, the market surveillance authorities may seek the assistance of the national authorities responsible for the notification of the Notified Body concerned – see §144: comments on Article 19.
Full quality assurance
In order to check that conformity assessment procedure involving the manufacturer’s full quality assurance system has been correctly applied, the market surveillance authorities can request from the manufacturer or his authorised representative communication of the relevant elements of the documentation of the manufacturer’s full quality assurance system – see §407: comments on Annex X 4.
§100 Action to deal with non-compliant machinery
Non-compliant CE marking
If a market surveillance authority discovers a non-conformity with respect to the CEmarking, the corrective action to be taken is set out in Article 17. The safeguard clause set out in Article 11 is only to be used if the action taken according to Article 17 fails to put an end to the non-conformity – see §142: comments on Article 17.
Failure to comply with the essential health and safety requirements
If a market surveillance authority discovers that machinery that has been placed on the market fails to comply with the relevant essential health and safety requirements, the authority should first require the manufacturer or his authorised representative to take the necessary corrective action to bring the machinery into conformity or to withdraw it from the market within a timeframe determined by the market surveillance authority[41]. Such corrective measures should be taken with respect to all items of the machinery that have the same design or construction defect and be applied throughout the EU market.
If the product concerned creates a serious risk, the market surveillance authority shall also require the manufacturer to take appropriate action with respect to machinery that has already been placed on the market or put into service such as, for example, a recall of the product[42]. Where the product possess a serious and immediate risk and there is not ready access or response from the manufacturer, the market surveillance authority may take action to restrict or stop the use and supply of the product urgently through contact with the supply chain and users. In this case the manufacturer should be contacted as soon as possible and asked to correct the non-compliance.
If the necessary corrective actions are not undertaken voluntarily by the manufacturer within the timeframe determined by the market surveillance authority, the Member State must take the necessary measures to ensure that the unsafe products are withdrawn from the market. Such measures must be notified to the Commission and the other Member States in accordance with the safeguard clause – see §123: comments on
Article 11.
The market surveillance authorities shall also take appropriate measures to ensure users are alerted, where possible, in cooperation with the economic operators concerned, in order to prevent accidents or damage to health that might result from the defect that has been identified[43].
If machinery presenting a serious risk is withdrawn from the market, whether voluntarily or by means of a restrictive measure, is or brought into conformity by voluntary corrective action, the Member State concerned must inform the other Member States and the Commission in order to enable them to check that the necessary corrective actions are taken throughout the EU – see §144: comments on Article 19. The Rapid Alert System (RAPEX) originally established under the General Product Safety Directive is now used for this purpose[44].
It should be noted that when the market surveillance authorities take a compulsory measure restricting the placing on the market of machinery presenting a serious risk, the notification under the RAPEX system does not remove the obligation for the Member State concerned to notify the measure according to the safeguard clause of the Machinery Directive – see §123: comments on Article 11.
§101 Unsafe consumer products
In addition to the provisions of the Machinery Directive and the Regulation setting out the requirements for accreditation and market surveillance relating to the marketing of products, certain specific provisions of the General Product Safety Directive apply with respect to machinery intended for or likely to be used by consumers, where the Machinery Directive or the Regulation do not include equivalent provisions.[45] In particular the following provisions are applicable:
- the obligation for distributors to exercise due care and cooperate with the market surveillance authorities[46];
- the obligation for producers and distributors to inform the authorities about unsafe products and to cooperate with the authorities in order to prevent risks to consumers[47];
- certain measures that can be taken by the market surveillance authorities with respect to unsafe products[48].
§102 Controls at the external borders of the EU
In many cases, in particular for mass-produced products imported into the EU from third countries, the most effective way to carry out market surveillance is to check the conformity of such products at the point of entry into the EU market, before they are dispersed throughout the distribution networks of the Member States.
Articles 27 to 29 of Regulation (EC) No 765/2008 which, for this aspect, repeals and replaces Regulation (EEC) No 339/93, provide the legal framework for such controls. These provisions are fully applicable for imported machinery.
Member States must provide the authorities in charge of the control of products entering the EU market (usually, the Customs authorities) with the necessary powers and resources to enable them to carry out, on an adequate scale, appropriate checks on the characteristics of machinery before it is released for free circulation[49].
The necessary cooperation and exchange of information must be organised between these authorities and the authority or authorities in charge of market surveillance for machinery[50]. In particular, market surveillance authorities shall provide authorities in charge of external border controls with information on product categories in which a serious risk or non-compliance has been identified[51].
The authorities in charge of the external border controls shall suspend release of machinery for free circulation within the EU in the following cases:
- if complete machinery does not bear the CE marking and the other markings required by the Machinery Directive or has been affixed with the CE marking in a false or misleading manner, or is not accompanied by the EC Declaration of Conformity signed by the manufacturer or his authorised representative;
- if there is cause to believe that the machinery presents a serious risk to health and safety[52].
The authorities in charge of the external border controls shall suspend release of partly completed machinery for free circulation within the EU in the following cases:
- if the partly completed machinery is not accompanied by a Declaration of Incorporation – see §384: comments on Annex II 1 B;
- if the partly completed machinery is not accompanied by assembly instructions – see §390: comments on Annex VI.
The market surveillance authorities must be immediately informed of any such suspension. They must release the product for free circulation within 3 days unless action has been initiated by the market surveillance authorities. This does not mean the product has to be investigated or tested within these 3 days, but the market surveillance authority has to decide, in this period, if they want to carry out such testing or examination and to inform the border control authority so the product is not released for free circulation. Normally, the market surveillance authority will visit to see the product in the 3-day period to make an initial assessment, but with access to modern communication tools between the authorities, a visit may not always be necessary.
The Regulation sets out the procedures to be followed if the machinery has not been subject to the appropriate conformity assessment procedure, if it fails to comply with the applicable essential health and safety requirements, or if the machinery presents a serious risk[53].
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Article 5
Placing on the market and putting into service
1. Before placing machinery on the market and/or putting it into service, the manufacturer or his authorised representative shall:
- ensure that it satisfies the relevant essential health and safety requirements set out in Annex I;
- ensure that the technical file referred to in Annex VII, part A is available;
- provide, in particular, the necessary information, such as instructions;
- carry out the appropriate procedures for assessing conformity in accordance with Article 12;
- draw up the EC declaration of conformity in accordance with Annex II, part 1, Section A and ensure that it accompanies the machinery;
- affix the CE marking in accordance with Article 16.
. . .
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§103 The obligations of machinery manufacturers
Article 5 (1) provides a summary of the obligations to be fulfilled by manufacturers of machinery before placing their products on the market or putting them into service – see §78 to §81: comments on Article 2 (i).
It should be noted that the term 'machinery' is used here in the broad sense. These obligations thus apply to manufacturers of machinery referred to in Article 1 (1) (a) to (f): machinery in the strict sense, interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing and removable mechanical transmission devices - see §33: comments on the first paragraph of Article 2.
All or part of the obligations summarised in Article 5 (1) (a) to (f) can also be fulfilled by the manufacturer’s authorised representative – see §84 and §85: comments on Article 2
(j).
In most cases, these obligations must be fulfilled before the machinery is placed on the market in the EU – see §73: comments on Article 2 (h). However, for machinery that is not placed on the market such as, for example machinery manufactured or imported into the EU by a user for his own use, the obligations must be fulfilled before the machinery is put into service – see §80 and §81: comments on Article 2 (i).
Article 5 (1) (c) requires the manufacturer to provide the necessary information and instructions with the machinery. In this regard, it should be noted that providing the necessary information on the machinery and drafting the instructions is considered as part of the design and construction of the machinery and is subject to specific essential health and safety requirements – see §244: comments on section 1.7 of Annex I.
Article 5 (continued)
. . .
- Before placing partly completed machinery on the market, the manufacturer or his authorised representative shall ensure that the procedure referred to in Article 13 has been completed.
. . .
§104 The obligations of manufacturers of partly completed machinery
Article 5 (2) refers to the obligations of manufacturers of partly completed machinery as defined in Article 2 - see §46: comments on Article 2 (g). The obligations of manufacturers of partly completed machinery are summarised in Article 13 – see §131: comments on Article 13.
Article 5 (continued)
. . .
- For the purposes of the procedures referred to in Article 12, the manufacturer or his authorised representative shall have, or shall have access to, the necessary means of ensuring that the machinery satisfies the essential health and safety requirements set out in Annex I.
. . .
§105 Means of ensuring the conformity of machinery
Article 5 (3) refers to the obligation referred to in Article 5 (1) (d) to carry out the appropriate conformity assessment procedure according to Article 12.
In the case of machinery subject to the procedure for assessment of conformity with internal checks on the manufacture described in Annex VIII, the necessary verifications may be carried out by or on behalf of the manufacturer or his authorised representative. Whether the conformity assessment of the machinery is carried out by the manufacturer himself or entrusted to his authorised representative, the person carrying out the conformity assessment must have, or have access to the necessary means to verify the conformity of the machinery with the applicable health and safety requirements. The means may include, for example, access to the necessary qualified personnel who have knowledge of both the Machinery Directive and relevant standards, access to the necessary information, the competency and the equipment needed to carry out the necessary design checks, calculations, measurements, functional tests, strength tests, visual inspections and checks on information and instructions to ensure the conformity of the machinery with the relevant essential health and safety requirements.
When machinery is designed and constructed according to harmonised standards, the standards normally specify the means to be used to verify the conformity of the machinery with their specifications[54]. Access to the relevant standards is required in this case.
In the case of machinery belonging to one of the categories listed in Annex IV for which the full quality assurance procedure described in Annex X is used, the means to carry out the necessary verifications must be documented in the manufacturer’s full quality assurance system – see §403: comments on paragraph 2.2 of Annex X.
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Article 5 (continued)
. . .
4. Where machinery is also the subject of other Directives relating to other aspects and providing for the affixing of the CE marking, the marking shall indicate that the machinery also conforms to the provisions of those other Directives.
However, where one or more of those Directives allow the manufacturer or his authorised representative to choose, during a transitional period, the system to be applied, the CE marking shall indicate conformity only to the provisions of those Directives applied by the manufacturer or his authorised representative. Particulars of the Directives applied, as published in the Official Journal of the European Union, shall be given on the EC declaration of conformity.
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§106 CE marking according to other EU legislation
Article 5 (4) concerns the obligation referred to in Article 5 (1) (f): the affixing of the CE marking. Article 5 (4) is a reminder that other EU legislation (Regulations or Directives) providing for the affixing of the CE marking may be applicable to machinery or partly completed machinery (note that although under the Machinery Directive a CE mark must not be placed on partly completed machinery, it may carry a CE mark due to other relevant EU legislation applying such as ATEX – see §251: comments on Annex I 1.7.3 – third paragraph). In that case, the manufacturer must ensure that he has fulfilled his obligations according to all of the EU legislation applicable to his product before affixing the CE marking – see §89 to §92: comments on Article 3.
Besides the CE marking of machinery as proof of their compliance with the relevant EU Directives and Regulations requiring CE-marking, other mandatory affixing and marking may be required by EU legislation[55].
Article 6
Freedom of movement
- Member States shall not prohibit, restrict or impede the placing on the market and/or putting into service in their territory of machinery which complies with this Directive.
- Member States shall not prohibit, restrict or impede the placing on the market of partly completed machinery where the manufacturer or his authorised representative makes a declaration of incorporation, referred to in Annex II, part 1, Section B, stating that it is to be incorporated into machinery or assembled with other partly completed machinery to form machinery.
. . .
§107 Free movement of machinery and partly completed machinery
Article 6 (1) and (2) set out obligations intended to fulfil one of the fundamental objectives of the Machinery Directive: the free movement of machinery and partly completed machinery within the single market.
In Article 6 (1), the term 'machinery' is used in the broad sense to designate all of the products referred to in Article 1 (1) (a) to (f) – see §33: comments on the first paragraph of Article 2.
According to the obligations set out in Article 6, the Member States may not impose any requirements or procedures for the placing on the market of machinery or partly completed machinery or the putting into service of machinery, for the hazards covered by the Machinery Directive, other than those set out in that Directive.
The obligation to allow free movement of machinery and partly completed machinery that complies with the Directive does not prevent Member States from regulating the installation and use of machinery within certain limits – see §139 and §140: comments on Article 15.
By virtue of the Agreement on the European Economic Area (EEA)[56], machinery and partly completed machinery that complies with the Machinery Directive also benefits from free movement in Iceland, Liechtenstein and Norway. The same is true in Switzerland by virtue of the Mutual Recognition Agreement (MRA) with the EU[57], and in Turkey, Andorra and San Marino by virtue of the Customs Union Agreements between the EU and these countries[58].
Article 6 (continued)
3. At trade fairs, exhibitions, demonstrations, and such like, Member States shall not prevent the showing of machinery or partly completed machinery which does not conform to this Directive, provided that a visible sign clearly indicates that it does not conform and that it will not be made available until it has been brought into conformity. Furthermore, during demonstrations of such non-conforming machinery or partly completed machinery, adequate safety measures shall be taken to ensure the protection of persons.
§108 Trade fairs, exhibitions and demonstrations
Trade fairs, exhibitions and demonstrations provide an opportunity for machinery manufacturers, importers and distributors to promote new and innovative products. The provisions of Article 6 (3) are intended to ensure that the Machinery Directive does not constitute an obstacle to the promotion of such products – see §19: comments on Recital 17. In some cases, the companies concerned may wish to see whether their products interest potential customers before carrying out the relevant conformity assessment procedure. In other cases, the procedure may not have been completed at the time the machinery is put on display. Manufacturers, importers or distributors may also wish to exhibit products that are not intended for the EU market. Products may also be displayed with certain guards or protective devices removed in order to show their operating characteristics more clearly.
According to Article 6 (3), such practices are authorised. However, in order to provide clear information to potential customers and avoid unfair competition with exhibitors of products that are in conformity with the Machinery Directive, products that are not in conformity with the provisions of the Directive must be accompanied by a visible sign. This must clearly indicate that they are not in conformity and will not be available for supply into the EU until they have been brought into conformity. It is helpful for the organisers of Trade Fairs to remind exhibitors of their obligation in this respect.
The Machinery Directive does not specify a particular format or wording for this sign. The following wording can be suggested for machinery that the manufacturer intends to bring into conformity and place on the market in the EU:
The machinery displayed is not in conformity with the Machinery Directive 2006/42/EC.
Visitors are informed that the machinery will be made available in the European Union only once it has been brought into conformity.
The necessary precautions must be taken during exhibitions and demonstrations in order to ensure the safety of the demonstrators and the public, particularly if products are shown with guards or protective devices removed. With respect to the health and safety of demonstrators or other employees of the exhibitors, the necessary measures must be taken in accordance with the national provisions implementing the relevant EU Directives on the protection of the health and safety of workers.
Article 7
Presumption of conformity and harmonised standards
1. Member States shall regard machinery bearing the CE marking and accompanied by the EC declaration of conformity, the content of which is set out in Annex II, part 1, Section A, as complying with the provisions of this Directive.
. . .
§109 Presumption of conformity conferred by the CE marking and the EC Declaration of Conformity
Article 7 (1) explains the role of the CE marking and the EC Declaration of Conformity as “passports” facilitating the free movement of machinery in the single market referred to in Article 6 (1).
The EC Declaration of Conformity must accompany the machinery. This implies that the EC Declaration of Conformity must be supplied with the machinery by the manufacturer when the machinery is placed on the market and it must be passed on by other economic operators, such as importers or distributors, to the user of the machinery – see §83: comments on Article 2 (i).
It should be underlined that the obligation set out in Article 7 (1) for the Member States to regard machinery bearing the CE-marking and accompanied by an EC Declaration of Conformity as complying with the Machinery Directive does not affect the duty of the Member States to carry out market surveillance to ensure that products bearing the CEmarking and accompanied by an EC Declaration of Conformity really comply with the requirements of the Machinery Directive and their duty to ensure that non-compliant products bearing the CE-marking are withdrawn from the market – see §93 and §94: comments on Articles 4 (1), §122 to §126: comments on Article 11, and §142: comments on Article 17.
Article 7 (continued)
. . .
2. Machinery manufactured in conformity with a harmonised standard, the references to which have been published in the Official Journal of the European Union, shall be presumed to comply with the essential health and safety requirements covered by such a harmonised standard.
. . .
§110 The presumption of conformity conferred by the application of harmonised standards
The reference to European standards is a key element of the “New Approach to technical harmonization and standards” that is followed in the Machinery Directive. The Directive sets out the mandatory essential health and safety requirements for machinery while detailed technical specifications for fulfilling these essential health and safety requirements are given in European harmonised standards – see §87: comments on Article 2 (l).
Once a European harmonised standard has been adopted, the European standardisation organisation communicates it to the European Commission so that the references of the standard can be published in the Official Journal of the European Union (OJEU).
Once the reference of a harmonised standard has been published in the OJEU, application of its specifications confers a presumption of conformity with the essential health and safety requirements covered by the standard. This presumption of conformity exists from the date on which the reference of the standard is first published in the OJEU. The presumption of conformity ceases when the standard is replaced by a new or revised standard on the “date of cessation of presumption of conformity” that is specified in the OJEU for machinery placed on the market after that date – see §114: comments on Article 7 (3).
It is important to understand that the presumption of conformity only extends to the essential health and safety requirements covered by the harmonised standard. Annex Z (in CEN standards) will indicate which essential health and safety requirements are covered. The manufacturer will need to carry out a risk assessment and compliance procedure for the risk areas associated to the relevant essential health and safety requirements. For Annex IV machinery (broad sense) the harmonised standards approach cannot be used if the standard does not cover all relevant essential health and safety requirements of the Directive.
It should be noted that, following formal objection, the references of certain standards may be published in the OJEU with a warning withdrawing the presumption of conformity for certain parts of the standard – see §121: comments on Article 10.
Application of draft European standards (identified by the prefix "prEN") or European standards the references of which have not been published in the OJEU does not confer a presumption of conformity with the essential health and safety requirements of the Machinery Directive.
Information about the subject of the standard (the category of machinery or the aspect of machinery safety covered by the standard) can be found in the clause of the standard relating to its scope. Additional information on the essential health and safety requirements of the Machinery Directive dealt with (or not dealt with) by the standard is provided in an informative Annex “Z” to the standard, which indicates as well the supported legislation and the relevant standardisation request.
Where a standard or part of a standard is referred to by a normative reference in a European harmonised standard, the specifications of the standard or parts of the standard referred to become part of the harmonised standard and their application confers a presumption of conformity with the essential health and safety requirements they cover. This remains true, even if the standard referred to is no longer in force (unless its reference has been withdrawn from the OJEU following a formal objection – see §121: comments on Article 10). On the other hand, application of the latest version of the standard referred to also confers a presumption of conformity with the essential health and safety requirements concerned, provided its reference has been published in the OJEU.
The presumption of conformity conferred by the application of a harmonised standard is not absolute, since the conformity of the standard itself can be challenged – see §119 to §121: comments on Article 10. However, the presumption of conformity conferred by the application of a harmonised standard gives a certain legal certainty for the manufacturer, since he does not have to provide further proof of conformity with the essential health and safety requirements covered by the standard.
Furthermore, in the case of categories of machinery listed in Annex IV, application of a harmonised standard that covers all the essential health and safety requirements that are applicable to the machinery enables the manufacturer to carry out the conformity assessment of the machinery without recourse to a Notified Body – see §129: comments on Article 12 (3).
It should be noted that, although the application of harmonised standards facilitates the risk assessment, it does not entirely dispense the machinery manufacturer from the obligation to carry out a risk assessment for the machinery – see §159: comments on General Principle 1 of Annex I.
Even when a given essential health and safety requirement is covered by a harmonised standard, a machinery manufacturer remains free to apply alternative specifications. The voluntary nature of harmonised standards is intended to prevent technical standards being an obstacle to the placing on the market of machinery incorporating innovative solutions.
However, a harmonised standard provides an indication of the state of the art at the time it was adopted. In other words, the harmonised standard indicates the level of safety which can be expected of a given type of product at that time. A machinery manufacturer who chooses to apply other technical specifications must be able to demonstrate that his alternative solution is in conformity with the EHSRs of the Machinery Directive and provides a level of safety that is at least equivalent to that afforded by application of the specifications of the harmonised standard – see §161 and §162: comments on General Principle 3 of Annex I.
When a manufacturer chooses not to apply harmonised standards or to apply only parts of a harmonised standard, he must include in the technical file the risk assessment undertaken and the steps taken to comply with the essential health and safety requirements – see §392: comments on Annex VII A 1 (a). In such a case, the reference of the harmonised standard should not be listed as such in the manufacturer’s EC Declaration of Conformity, but the Declaration may indicate which parts or clauses of a harmonised standard have been applied – see §383: comments on Annex II A 1 (7).
§111 The classification of machinery standards
Machinery standards are classified into three types, A, B and C. The purpose of this classification is to enable the authors of standards for particular categories of machinery to refer to horizontal standards providing well tried technical solutions. The horizontal A and B-type standards can also help manufacturers designing machinery for which Ctype standards are not available. A technical report on the use and nature of type A, B and C standards is being developed by CEN as a transposition of an already existing ISO technical report[59].
The nature of the presumption of conformity conferred by application of the harmonised standards of these three types must be distinguished: A-type standards
A-type standards specify basic concepts, terminology and design principles applicable to all categories of machinery. Application of such standards alone, although providing an essential framework for the correct application of the Machinery Directive, is not sufficient to ensure conformity with the relevant essential health and safety requirements of the Directive and therefore does not give a presumption of conformity.
For example, the application of standard EN ISO 12100[60] ensures that the risk assessment is carried out according to the requirements of General Principle 1 of Annex I, but it is not sufficient to show that the protective measures taken by the manufacture to deal with the hazards presented by the machinery comply with the relevant essential health and safety requirements of Annex I. B-type standards
B-type standards deal with specific aspects of machinery safety or specific types of safeguard that can be used across a wide range of categories of machinery. Application of the specifications of B-type standards confers a presumption of conformity with the essential requirements of the Machinery Directive that they cover when a C-type standard or the manufacturer's risk assessment shows that a technical solution specified by the B-type standard is adequate for the particular category or model of machinery concerned.
Application of B-type standards that give specifications for safety components that are independently placed on the market confers a presumption of conformity for the safety components concerned and for the EHSRs covered by the standards – see §42, comments on Article 2 (c). C-type standards
C-type standards provide specifications for a given category of machinery such as, for example, mechanical presses, combine harvesters or compressors. The different types of machinery belonging to the category covered by a C-standard have a similar intended use and present similar hazards. C-type standards may refer to A or B-type standards, indicating which of the specifications of the A or B-type standard are applicable to the category of machinery concerned. When, for a given aspect of machinery safety, a Ctype standard deviates from the specifications of an A or B-type standard, the specifications of the C-type standard take precedence over the specifications of the A or B-type standard.
Application of the specifications of a C-type standard confers a presumption of conformity with the essential health and safety requirements of the Machinery Directive covered by the standard provided that the manufacturer has determined in his risk assessment that the scope and the significant hazards covered by the standard correspond with his actual machinery[61].
Certain C-type standards are organised as a series of several parts, Part 1 of the standard giving general specifications applicable to a family of machinery and other parts of the standard giving specifications for specific categories of machinery belonging to the family, supplementing or modifying the general specifications of Part 1. For C-type standards organised in this way, the presumption of conformity with the essential requirements of the Machinery Directive is conferred by application of the general Part 1 of the standard together with the relevant specific part of the standard.
§112 The development of harmonised standards for machinery
Harmonised standards for machinery are developed by the Technical Committees (TCs) of the European Standardisation Organisations, CEN and CENELEC. The TCs are constituted by representatives mandated by the national member organisations of CEN and CENELEC. The TCs involved in developing standards supporting the Machinery Directive include the following:
CEN
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TC 10
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Lifts, escalators and moving walks
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TC 33
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Doors, windows, shutters
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TC 47
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Atomising oil burners and their components - Function - Safety - Testing
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TC 98
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Lifting platforms
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TC 114
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Safety of machinery
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TC 122
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Ergonomics
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TC 123
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Lasers and photonics
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TC 131
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Gas burners using fans
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TC 142
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Woodworking machines - Safety
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TC 143
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Machine tools - Safety
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TC 144
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Tractors and machinery for agriculture and forestry
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TC 145
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Plastics and rubber machines
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TC 146
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Packaging machines - Safety
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TC 147
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Cranes - Safety
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TC 148
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Continuous handling equipment and systems - Safety
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TC 149
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Power-operated warehouse equipment
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TC 150
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Industrial trucks – safety
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TC 151
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Construction equipment and building material machinery - Safety
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TC 153
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Machinery intended for use with foodstuffs and feed
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TC 168
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Chains, ropes, webbing, slings and accessories - Safety
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TC 169
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Light and lighting
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TC 182
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Refrigerating systems, safety and environmental requirements
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TC 186
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Industrial thermo processing - Safety
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TC 188
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Conveyor belts
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TC 192
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Fire and Rescue service equipment
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TC 196
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Machines for underground mines - Safety
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TC 197
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Pumps
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TC 198
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Printing and paper machinery - Safety
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TC 200
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Tannery machines and plants - Safety
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TC 202
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Foundry machinery
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TC 211
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Acoustics
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TC 213
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Cartridge operated hand-held tools - Safety
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TC 214
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Textile machinery and accessories
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TC 221
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Shop fabricated metallic tanks and equipment for storage tanks and for service stations
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TC 231
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Mechanical vibration and shock
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TC 232
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Compressors, vacuum pumps and their systems
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TC 255
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Hand-held, non-electric power tools - Safety
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TC 256
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Railway applications
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TC 270
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Internal combustion engines
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TC 271
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Surface treatment equipment - Safety
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TC 274
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Aircraft ground support equipment
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TC 310
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Advanced manufacturing technologies and their applications
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TC 313
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Centrifuges - Safety requirements
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TC 322
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Equipments for making and shaping of metals - Safety requirements
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TC 354
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Non-type approved light motorized vehicles for the transportation of persons and goods and related facilities
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TC 397
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Project Committee - Baling presses - Safety requirements
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TC 429
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Project Committee - Food hygiene - Commercial warewashing machines - Hygiene requirements and testing
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TC 433
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Entertainment Technology - Machinery, equipment and installations
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CENELEC
TC 44X Safety of machinery – electro technical aspects
TC 61 Safety of household and similar electrical appliances
TC 116 Safety of hand-held and transportable motor-operated electric tools
TC 88 Wind turbine systems
Draft standards are prepared by Working Groups (WGs) set up by the relevant TC. The WGs are made up of experts nominated by the national standardisation organisations. The draft standard (prEN) prepared by the WG is sent by the TC to the national standardisation organisations who circulate the draft to interested parties at national level for comments (public enquiry). Public enquiry is combined with a majority weighted vote of national standardisation organisations. The comments received are sent back to the TC and examined by the WG in order to improve the draft if relevant Depending on the outcome of the vote and upon TC decision it is possible to publish the standard straight after the enquiry. In case there are technical changes to be made to the draft standard after enquiry, a separate weighted majority vote by the national standardisation organisations is needed for adoption.
Many European harmonised standards are now developed within the framework of the agreements relating to cooperation between CEN and the International Standardisation Organisation (ISO) or between CENELEC and the International Electrotechnical Commission (IEC). The agreement between CEN and ISO is known as the Vienna
Agreement. The agreement between CENELEC and IEC is known as the Frankfurt Agreement (former Dresden Agreement). When these agreements are applied, the draft standards may be prepared by the TCs and WGs of ISO or IEC. However, before being adopted as European harmonised standards, they are subject to the enquiry and adoption procedures of CEN or CENELEC, which are normally carried out in parallel with the ISO or IEC procedures.
The reference material on the technical cooperation between CEN and ISO as well as CENELEC and IEC is available on CEN and CENELEC website.
§113 The identification of harmonised standards
Draft European standards are identified by a reference number preceded by the prefix “prEN”, followed by the date of the draft. Such draft European standards are made publicly available at the Public Enquiry stage.
Once the standard has been adopted by CEN or CENELEC, it is identified by the same number preceded by the prefix “EN”, and followed by the date (year) of adoption. When a standard is amended or revised and the new version bears the same number, the date of adoption makes it possible to distinguish the new version of the standard from the previous version.
When a CEN standard is identical to an international standard adopted by ISO, the European and International standards have the same number and the reference of the harmonised standard has the prefix “EN ISO”. A CENELEC standard identical or based on an IEC standard has also an identical EN number. However, for both European Standardisation Organisations, the reference of the corresponding ISO or IEC standard is indicated in brackets after the title of the European standard.
The national member organisations of CEN and CENELEC must give the harmonised standard the status of a national standard without any alteration. In the reference of the national version of a harmonised standard, the prefix “EN” is preceded by the prefix used to identify national standards in the country concerned. Harmonised standards are published by the national standardisation organisations of the EU Member States with the following prefixes:
“ÖNORM EN” in Austria “UNI EN” in Italy
“NBN EN” in Belgium “LVS EN” in Latvia
“БДС EN” in Bulgaria “LST EN” in Lithuania
“HRN EN” in Croatia “EN” in Luxembourg
“CYS EN” in Cyprus “MSA EN” in Malta
“ČSN EN” in the Czech Republic “NEN EN” in the Netherlands
“DS EN” in Denmark “PN EN” in Poland
“EVS EN” in Estonia “NP EN” in Portugal
“SFS EN” in Finland “SR EN” in Romania
“NF EN” in France “STN EN” in Slovakia
“DIN EN” in Germany “SIST EN” in Slovenia
“EN” in Greece “UNE EN” in Spain
“MSZ EN” in Hungary “SS EN” in Sweden
“IS EN” in Ireland “BS EN” in the United Kingdom
The same standards are published with the following prefixes in EFTA countries:
“IST EN” in Iceland “SN EN” in Switzerland
“NS EN” in Norway
In some cases, the date included in the reference of the national version of the harmonised standard is later than the date included in the reference of the standard published in the OJEU, due to the fact that the publication of the standard at national level may have occurred in the following year.
In the EC Declaration of Conformity of machinery, the European harmonised standards applied by the manufacturer may be identified using either the national reference, with one of the national prefixes listed above, or the reference as listed the in OJEU with the prefix "EN" only – see §383: comments on Annex II 1 A (7).
Article 7 (continued)
. . .
3. The Commission shall publish in the Official Journal of the European Union the references of the harmonised standards.
. . .
§114 Publication of the references of harmonised standards in the OJEU
Consolidated lists of harmonised standards are published in the C-series of the OJEU in the form of a Commission communication in the framework of the implementation of the Machinery Directive. The list is regularly updated when the references of new or revised standards are communicated to the European Commission by CEN and CENELEC.
CEN and CENELEC communicate the references several times a year, usually quarterly.
The list published in the OJEU includes the following 5 columns:
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Column 1
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indicates the European standardisation organisation that has adopted the standard: CEN or CENELEC;
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Column 2
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indicates the reference of the standard, that is to say, its number, the date of its adoption by CEN or CENLEC and its title;
If the standard has been amended, the reference of the amended version of the standard is indicated. Once the references of such amended standards have been published in the OJEU, the amended version of the standard confers presumption of conformity with the relevant essential
health and safety requirements of the Machinery Directive;
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Column 3
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indicates the date on which the reference of the standard was first published in the OJEU. This is the date from which application of the standard confers a presumption of conformity with the essential health and safety requirement it covers;
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Column 4
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gives the references of the superseded standard. This column is only used if there was already a harmonised standard dealing with the same subject when the new or revised standard was adopted. In most cases, the superseded standard is an earlier version of a standard that has been revised;
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Column 5 indicates the date of cessation of presumption of conformity of the superseded standard. This column is only used when the reference of a superseded standard is given in the fourth column. The date of cessation of presumption of conformity is fixed by the Commission. In general, the date of cessation of presumption of conformity is the same as the date fixed by CEN or CENELEC for the withdrawal of the superseded standard by the national standardisation organisations.
The new standard confers a presumption of conformity as from the date on which its reference is published in the OJEU, while the superseded standard continues to confer a presumption of conformity until the date of cessation of presumption of conformity indicated in the fifth column. During the period between the two dates (the transition period) the specifications of either the new standard or the superseded standard confer a presumption of conformity with the essential health and safety requirements they cover.
Under the line listing of a particular standard it may be added a “warning” that either limits the presumption of conformity in some way, such as not applying it to certain sections of the standard, or pointing out that the standard does not address certain essential health and safety requirements in an appropriate manner. Such warnings have followed a formal objection. In cases of more fundamental concerns raised in a formal objection then the whole reference in the OJEU may be removed and with it the presumption of conformity.
Article 7 (continued)
. . .
4. Member States shall take the appropriate measures to enable the social partners to have an influence at national level on the process of preparing and monitoring the harmonised standards.
§115 Participation of the social partners in standardisation
Standardisation is based on a consensus between the interested parties. The parties interested in machinery standards include, for example, machinery manufacturers, users of machinery such as employers, workers and consumers, occupational health and safety institutions, Notified Bodies, other relevant NGOs and public authorities. Rules for the participation of the interested parties are usually subject to national provisions relating to the organisation of standardisation; for example, a fee may be charged to participate depending on the individual national standardisation organisation.
Article 7 (4) sets out a specific requirement for Member States to ensure that appropriate measures are taken to enable the social partners, that is to say the representatives of employers and employees, to have an influence on the standardisation process at national level. It is up to Member States to decide what measures are appropriate and how they are put into effect.
However, societal stakeholders as defined in Annex III to the Regulation (EU) 1025/2012 and SMEs, can also participate at European level directly with the European Standardisation Organisations (Articles 5 and 6 of Regulation (EU) 1025/2012).
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Article 8 [62]
Specific measures
1. The Commission may take any appropriate measure relating to the following:
- updating of the indicative list of safety components in Annex V referred to in Article 2 (c);
- restricting the placing on the market of machinery referred to in Article 9.
Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 22 (3).
. . .
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§116 Measures subject to the Regulatory Committee Procedure
Article 8 (1) sets out the two cases in which the Commission can adopt measures after consulting the Machinery Committee according to the Regulatory procedure with scrutiny – see §147: comments on Article 22 (3).
- Article 8 (1) (a) enables the Commission to update the indicative list of safety components set out in Annex V, for example, by adding to the list further examples of components that correspond to the definition given in Article 2 – see §42: comments on Article 2 (c). This may be done if it appears that certain existing safety components have been omitted from the list or if new safety components are developed.
- Article 8 (1) (b) enables the Commission to adopt a measure restricting the placing on the market of machinery presenting risks due to the shortcomings of a harmonised standard, presenting the same risk as machinery subject to a justified safeguard action or at the request of a Member State – see §118: comments on
Article 9.
Article 8 (continued)
. . .
2. The Commission, acting in accordance with the procedure referred to in Article 22(2), may take any appropriate measure connected with the practical application of this Directive, including measures necessary to ensure cooperation of Member States with each other and with the Commission, as provided for in Article 19(1).
§117 Measures subject to the Advisory Committee procedure
Article 8 (2) enables the Commission to take any appropriate measure connected with the practical application of the Machinery Directive after consulting the Machinery Committee according to the Advisory procedure – see §147: comments on Article 22 (2). It also provides a legal basis for Commission support for the organisation of administrative cooperation (AdCo) between the market surveillance authorities of the Member States. This has now been implemented and support such as interpretation and funding for travel and accommodation for the official representative of a member states is now given by the Commission – see §144: comments on Article 19 (1).
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Article 9[63]
Specific measures to deal with potentially hazardous machinery
- When, in accordance with the procedure referred to in Article 10, the Commission considers that a harmonised standard does not entirely satisfy the essential health and safety requirements which it covers and which are set out in Annex I, the Commission may, in accordance with paragraph 3 of this Article, take measures requiring Member States to prohibit or restrict the placing on the market of machinery with technical characteristics presenting risks due to the shortcomings in the standard or to make such machinery subject to special conditions.
When, in accordance with the procedure referred to in Article 11, the Commission considers that a measure taken by a Member State is justified, the Commission may, in accordance with paragraph 3 of this Article, take measures requiring Member States to prohibit or restrict the placing on the market of machinery presenting the same risk by virtue of its technical characteristics or to make such machinery subject to special conditions.
- Any Member State may request the Commission to examine the need for the adoption of the measures referred to in paragraph 1.
- In the cases referred to in paragraph 1, the Commission shall consult the Member States and other interested parties, indicating the measures it intends to take in order to ensure, at Community level, a high level of protection of the health and safety of persons.116
Taking due account of the results of this consultation, it shall adopt the necessary measures.
Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 22(3).
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§118 Measures to deal with unsafe machinery presenting similar risks
The safeguard clause set out in Article 11 requiring the Member States to take appropriate measures to deal with unsafe machinery bearing the CE marking, applies to particular models of machinery. Article 9 enables the Commission to adopt measures to prohibit or restrict the placing on the market all models of machinery presenting risks due to the same technical characteristics. This article was amended by Directive 2009/127/EC which expanded the application from just persons to add “where appropriate, of domestic animals and property and, where applicable, of the environment”. The meaning of “where applicable, of the environment” restricts the application of this article to the potential or actual effect on the environment to that caused by “pesticides application machinery” and does not increase the scope in this respect to any other type of machinery.
Such measures can be adopted in the following circumstances:
Following a formal objection to a harmonised standard according to Article 10
The first circumstance is linked to the procedure set out in Article 10 for disputing a harmonised standard. When a formal objection is made against a harmonised standard, the Commission may adopt a decision withdrawing or restricting the presumption of conformity conferred by application of the standard on the grounds that certain of its specifications fail to satisfy the relevant essential health and safety requirements – see §121: comments on Article 10. Following such a decision, it may be considered necessary, in order to protect the health and safety of persons, to ensure that machinery designed according to the defective standard is withdrawn from the market or subject to certain restrictions.
Following a safeguard action according to Article 11
The second circumstance is linked to the safeguard clause procedure set out in Article 11. Following the notification of a measure taken by a Member State to prohibit or restrict the placing on the market of a particular model of unsafe machinery, the Commission adopts a decision stating whether or not it considers the measure to be justified – see §123: comments on Article 11 (3). Following such a decision, the Commission may adopt a Decision requiring all Member States to take the appropriate measures, in order to protect the health and safety of persons, to ensure that any other machinery having the same defect as the model subject to the original national measure should be withdrawn from the market or subject to certain restrictions i.e. similar to the action taken in the MS instigating the safeguard action.
At the request of the Member State
Article 9 (2) gives the Member States the possibility to initiate the process by requesting the Commission to examine the need for measures to prohibit or restrict the placing on the market of machinery presenting the same risk by virtue of its technical characteristics or to make such machinery subject to special conditions.
116 Article 9 (3) 2nd indent was amended by Directive 2009/127/EC of the European Parliament and of the Council of 21 October 2009 amending Directive 2006/42/EC with regard to machinery for pesticide application. OJ L 310, 25.11.2009, p. 29.
Before taking such measures, the Commission shall consult the interested parties. Since, the measures do not just concern a single manufacturer but may have consequences for all of the manufacturers of a given category of machinery, it is clear that organisations representing machinery manufacturers at EU level must be consulted. In general, the consultation of the interested parties is organised in the framework of the Machinery Working Group – see §148: comments on Article 22. The measure is then adopted after consultation of the Machinery Committee according to the Regulatory procedure with scrutiny – see §147: comments on Article 22 (3).
This system has been used, for example, to require Member States to prohibit the placing on the market of flail-type cutting attachments for portable hand-held brush cutters[64].
Article 10
Procedure for disputing a harmonised standard
Where a Member State or the Commission considers that a harmonised standard does not entirely satisfy the essential health and safety requirements which it covers and which are set out in Annex I, the Commission or the Member State shall bring the matter before the committee set up by Directive 98/34/EC, setting out the reasons therefor. The committee shall deliver an opinion without delay. In the light of the committee's opinion, the Commission shall decide to publish, not to publish, to publish with restriction, to maintain, to maintain with restriction or to withdraw the references to the harmonised standard concerned in the Official Journal of the European Union.
§119 Formal objections to harmonised standards
The application of harmonised standards the references of which are published in the OJEU confers a presumption of conformity with the essential health and safety requirements they cover – see §110: comments on Article 7 (2). However, according to Articles 10 and 11 the presumption of conformity can be challenged:
- Article 10 requires a Member State or the Commission to refer a harmonised standard to the Committee set up by Regulation 1025/2012[65] if they have evidence that certain essential health and safety requirements covered by the standard are not adequately fulfilled by its specifications.
- If the safeguard procedure set out in Article 11 is used and the Member State concerned considers that the non-conformity of the machinery subject to the restrictive measure is due to a shortcoming in a harmonised standard applied by
the manufacturer, the standard concerned is also referred to the Regulation 1025/2012 Committee – see §124: comments on Article 11 (4).
To avoid the need for such formal objections, the Member States are encouraged to follow the development of harmonised standards and to make their concerns known to CEN or CENELEC before harmonised standards are adopted. Participation in standardization by market surveillance authorities is foreseen at national level by article 7 of Regulation EU 1025/2012. The comments to draft standards are expected to be made during Enquiry stage directly by market surveillance authorities or via national mirror committees. If the information is received at a late stage of the standards development process (for example after a Formal Vote), it cannot always be integrated directly, but could be processed after the publication of the given standard, possibly resulting in an amendment or revision. By the same token, the standardisation organisations are encouraged to take due account of the concerns of the Member States when developing and adopting harmonised standards.
However, a Technical Committee needs to receive structured, concrete and adequately detailed technical and legal information in order to be able to address the concerns and develop a proper technical solution to the issue.
Only the Member States and the Commission have the possibility to make a formal objection against a harmonised standard. If other interested parties consider that a harmonised standard has serious shortcomings, they may draw the matter to the attention of the national authorities or the Commission and ask them to take appropriate action.
§120 The procedure for formal objections
A formal objection can be introduced when a harmonised standard has been adopted by the European Standardisation Organisation and its reference been communicated to the Commission for publication in the OJEU. A formal objection can also be introduced at any time after the publication of the reference of the harmonised standard in the OJEU.
The formal objection must be communicated by the Member State to the Commission via its Permanent Representation to the EU, indicating the reference of the standard concerned, the specifications of the standard that are considered to be defective and the grounds for the objection. A standard form for this purpose has been developed by the Regulation 1025/2012 Committee.
The formal objection is first discussed within the Machinery Working Group – see §148: comments on Article 22 – where the other Member States, the representatives of CEN or CENELEC and other interested parties are invited to express their opinions. The outcome of the discussion in the Machinery Working Group is reported by the Commission to the Regulation 1025/2012 Committee. This Committee is then consulted on a draft Commission Decision. The Decision is then adopted by the Commission and published in the L series of the OJEU.
§121 The outcome of a formal objection
The Commission Decision on a formal objection to a harmonised standard can take several forms:
- if the formal objection is not sustained, the Commission adopts a Decision to publish the reference of the standard in the OJEU, or to maintain the reference of the standard in the OJEU if it has already been published;
- if the formal objection is sustained, the Commission may decide not to publish the reference of the standard in the OJEU, or to withdraw the reference of the standard from the OJEU if it has already been published;
- if the shortcomings of the standard only concern certain specifications and the rest of the standard is considered adequate, the Commission may decide to publish the reference of the standard in the OJEU (or maintain the reference of the standard in the OJEU if it has already been published) with a warning restricting the presumption of conformity conferred by application of the standard.
When the reference of a harmonised standard is published in the OJEU with a warning restricting the presumption of conformity, this implies that the application of the specifications of the standard that are not subject to the restriction continue to confer a presumption of conformity with the essential health and safety requirements they cover. However, in order to comply with the essential health and safety requirements that are not fulfilled by the standard, the manufacturer must carry out a full risk assessment, choose adequate protective measures to deal with the hazards concerned and justify his choice in his technical file – see §392: comments on Annex VII A 1 (a). As the standard used does not carry a complete presumption of conformity, and the product concerned is listed in Annex IV then the procedure for assessment of conformity with internal checks on the manufacture of machinery, provided for in Annex VIII is not possible and either the EC type-examination procedure provided for in Annex IX, plus the internal checks on the manufacture of machinery provided for in Annex VIII, point 3, or the full quality assurance procedure provided for in Annex X will need to be used.
When the Commission adopts a Decision not to publish the reference of a standard in the OJEU, to withdraw a reference of a standard from the OJEU or to publish or to maintain the reference of a standard in the OJEU with a restriction, the Commission gives a mandate to the European Standardisation Organisation to revise the standard concerned in order to remedy the shortcomings that have been identified.
Article 11[66]
Safeguard clause
1. Where a Member State ascertains that machinery covered by this Directive, bearing the CE marking, accompanied by the EC declaration of conformity and used in accordance with its intended purpose or under conditions which can reasonably be foreseen, is liable to compromise the health and safety of persons and, where appropriate, domestic animals or property, it shall take all appropriate measures to withdraw such machinery from the market, to prohibit the placing on the market and/or putting into service of such machinery or to restrict free movement thereof.
. . .
§122 The safeguard clause
The safeguard clause is foreseen in paragraph (10) of Article 95 of the EC Treaty (now Article 114 of the TFEU) on which the Machinery Directive is based – see §2: comments on the citations:
“The harmonisation measures referred to above shall, in appropriate cases, include a safeguard clause authorising the Member States to take, for one or more of the noneconomic reasons referred to in Article 30, provisional measures subject to a Community control procedure”.
Article 11 sets out the procedure to be followed when the market surveillance authorities of a Member State discover that the presumption of conformity conferred by the CEmarking and the EC Declaration of Conformity is not founded – see §109: comments on
Article 7 (1). This Article was modified by the Directive 2009/127/EC to also apply “where applicable the environment” but only for machinery for pesticide application.
The safeguard procedure set out in Article 11 applies to machinery in the broad sense, in other words, it can be applied to any of the products listed in Article 1 (1), (a) to (f). It is not applicable to partly completed machinery.
When machinery is found not to comply with the applicable health and safety requirements despite the presence of the CE-marking, the Member State should first contact the manufacturer, his authorised representative or the person responsible for placing the machinery on the market and require him to bring the product into conformity or withdraw it from the market within a timeframe determined by the market surveillance authority – see §78 to §84: comments on Article 2 (i) and (j), and §100: comments on Article 4.
If the product is brought into conformity or withdrawn from the market voluntarily, there is no need to take the restrictive measures referred to in Article 11 (1) and consequently there is no legal basis for recourse to the safeguard procedure. However, if the machinery concerned presents a serious risk, Regulation (EC) No 765/2008 requires the Member State concerned to inform the Commission and the other Member States of the action taken using the RAPEX system[67].
In all cases where corrective action is taken by the manufacturer, it is important for the Member State concerned to inform the market surveillance authorities of the other Member States so that they can ensure that the necessary corrective measures are taken throughout the EU – see §100: comments on Article 4. This information can be communicated in the framework of the Machinery AdCo Group – see §144: comments on Article 19 and by using the Information Communication System for Market Surveillance (ICSMS) which is owned and operated by the Commission and implemented by Article 23 of Regulation (EC) No 765/2008 which foresaw the establishment of a General EU information support system. If the non-conformity subject to corrective action taken by the manufacturer results from a deficiency in the harmonised standard applied, the Member State must also take action with respect to the harmonised standard, if necessary by means of the formal objection procedure – see §119 to §121: comments on Article 10.
If voluntary measures to bring the product into conformity are not taken within the timeframe determined by the market surveillance authorities and if the non-conformity is liable to endanger the health and safety of persons or, where appropriate, domestic animals or property, or for pesticides machinery, the environment, the safeguard procedure set out in Article 11 must be followed.
Article 11 (1) describes the measures to be taken by the national market surveillance authorities. The measures may include suspending or prohibiting the placing on the market of the machinery and/or the putting into service of the machinery, or making these operations subject to certain restrictions. The form and content of the measures is a matter for the Member State concerned, but the measures must be both sufficient to protect the health and safety of persons and proportionate to the risk involved.
According to Article 21 (3) of Regulation (EC) No 765/2008, before such measures are taken, the interested parties must be given the opportunity to express their views unless this is not possible because of urgency. If measures are taken without the interested parties being heard, they must be given the opportunity to express their views as soon as possible.
According to Article 20 of the Regulation, in the case of machinery presenting a serious risk requiring rapid intervention, Member States may also order the recall of machinery already placed on the market, both in the supply chain and in service, in order to protect the health and safety of users.
The measure taken by the Member State according to Article 11 (1) must state the exact grounds on which it is based and be notified as soon as possible to the party concerned who shall at the same time be informed of the legal remedies available to him – see §145: comments on Article 20.
The decision taken by the Member State shall be published – see §143: comments on Article 18 (3).
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Article 11 (continued)
. . .
- The Member State shall immediately inform the Commission and the other Member States of any such measure, indicating the reasons for its decision and, in particular, whether the non-conformity is due to:
- failure to satisfy the essential requirements referred to in Article 5(1)(a);
- incorrect application of the harmonised standards referred to in Article 7(2);
- shortcomings in the harmonised standards themselves referred to in Article 7(2).
- The Commission shall enter into consultation with the parties concerned without delay.
The Commission shall consider, after this consultation, whether or not the measures taken by the Member State are justified, and it shall communicate its decision to the Member State which took the initiative, the other Member States, and the manufacturer or his authorised representative.
. . .
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§123 The safeguard procedure
Article 11 (2) and (3) set out the procedure to be followed at EU level when a national measure is taken in accordance with Article 11 (1). The measure must be notified by the Member State concerned to the European Commission, indicating the reasons for the measure. The notification shall be transmitted to the Commission by the Permanent Representation of the Member State concerned. At the same time, the other Member
States must be informed. The information can be communicated through the Machinery AdCo Group using the CIRCABC system – see §146: comments on Article 21. The Machinery AdCo Group has developed a special form to help Member States to transmit the necessary information. This form can be generated with much of the information filled in from the ICSMS system, completed and printed.
Note that Article 11 only applies to CE marked products that do not conform to the Machinery Directive. If a machine is found on the EU/EEA market that is not CE marked and which may be also non-compliant in other respects, the competent Member State Authority (MSA) should take appropriate action to ensure the machine is brought into compliance and CE marked or have it withdrawn from the market.
The notification should clearly indicate the essential health and safety requirements with which the machinery fails to comply and explain the nature of the risks to which these non-conformities give rise. If the market surveillance authorities have assessed the conformity of the machinery with reference to the specifications of a harmonised standard, the relevant clauses of the standard should also be indicated.
In order to enable the Commission to carry out its enquiry without delay, the national authorities should transmit all relevant documents with the notification. Relevant documents may include:
- photos or drawings of the machinery concerned showing the CE marking and the defects concerned;
- a copy of the EC Declaration of Conformity;
- the EC type-examination certificate or the certificate of approval of the manufacturer's full quality assurance system (if applicable);
- the relevant elements of the manufacturer's technical file if they are available;
- the relevant extracts from the manufacturer's instructions;
- reports of any tests or inspections on which the measure is based;
- details of any correspondence exchanged with the parties concerned, such as the manufacturer or his authorised representative, the importer or the distributor of the machinery, or the Notified Body involved.
The Commission services then examine the notification and the supporting documents and consult the parties concerned in order to consider whether or not the measure taken by the Member State is justified. The parties concerned include the authorities of the Member State that has notified the measure, the manufacturer of the machinery concerned or his authorised representative and, where applicable, the Notified Body involved in the conformity assessment of the machinery. An opportunity is given to the parties concerned to meet the Commission services to present their observations if they so wish.
If necessary, the Commission may seek independent expert advice in order to assess the file and, in some cases, to inspect the machinery concerned or carry out tests. The Commission then adopts a Decision which is communicated to the Member State which took the initial measure, to the other Member States, and to the manufacturer or his authorised representative. The Commission's Decision is published in the Official Journal of the European Union – see §143: comments on Article 18 (3).
If the Commission decides that the measure taken by the Member State is justified, the other Member States shall take the measures necessary to ensure the protection of the health and safety of persons with respect to the non-compliant machinery. If, on the other hand, the Commission decides that the measure taken by the Member State is not justified, the measure shall be withdrawn.
It should be noted that Decision No 768/2008 of the European Parliament and the Council of 9 July 2008 on a common framework for the marketing of products, sets out a
“safeguard procedure” that is intended to become the system for all relevant “CE marking” Directives and Regulations. A number of such legislation has now been revised to follow this Decision. However, the Machinery Directive 2006/42/EC has not yet been revised and the procedure described in Article 11 must be used until the Machinery Directive is so revised and aligned to the New Legislative Framework.
Article 11 (continued)
. . .
- Where the measures referred to in paragraph 1 are based on a shortcoming in the harmonised standards and if the Member State which instigated the measures maintains its position, the Commission or the Member State shall initiate the procedure referred to in Article 10.
. . .
§124 Shortcomings in harmonised standards
Article 11 (4) is applicable when the non-conformity notified according to Article 11 (1) and (2) is due to a shortcoming in the harmonised standard applied by the manufacturer. In that case, in addition to the procedure set out in Article 11 (3), a formal objection must be lodged either by the Member State concerned or by the Commission, according to the procedure set out in Article 10 – see §119 to §121: comments on Article 10.
Article 11 (continued)
. . .
- Where machinery does not conform and bears the CE marking, the competent Member State shall take appropriate action against whomsoever has affixed the marking and shall so inform the Commission. The Commission shall inform the other Member States.
. . .
§125 Action against the person who has affixed the CE marking
The provisions set out in Article 11 (1) to (4) deal with the measures to be taken with respect to products that bear the CE marking and that are liable to compromise the health and safety of persons and, where appropriate, domestic animals or property, or the environment in the case of pesticides machinery.
In addition to those measures, Article 11 (5) requires the Member State to take appropriate action with respect to the person who has affixed the CE marking on a noncompliant product and thereby taken the responsibility for placing the product on the market or putting it into service – see §141: comments on Article 16. That person may be the manufacturer his authorised representative or another person taking the responsibility for placing the product on the market who is considered as a manufacturer – see §78 to §81: comments on Article 2 (i).
The appropriate action shall be determined by the Member States according to the provisions implementing the Machinery Directive into national law. In general, the market surveillance authorities should first require the manufacturer or his authorised representative to take the measures necessary to put an end to the non-conformity. If the necessary measures are not taken within the timeframe determined by the market surveillance authorities, appropriate sanctions must be applied – see §150: comments on Article 23.
In such cases, the Member States must inform the Commission and the Commission shall inform the other Member States. For this purpose, the ICSMS system foreseen in Article 23 of Regulation (EC) No 765/2008 shall be used.
For non-conformities relating to the CE marking or the EC Declaration of Conformity – see §142: comments on Article 17.
Article 11 (continued)
. . .
6. The Commission shall ensure that Member States are kept informed of the progress and outcome of the procedure.
§126 Information on the safeguard procedure
According to Article 11 (6), the Commission shall keep the Member States informed of the progress and outcome of the safeguard procedure. The relevant information is provided to the Member States in the framework of the Machinery AdCo Group – see §144: comments on Article 19.
The Commission's Decision is published in the Official Journal of the European Union – see §143: comments on Article 18 (3).
Article 12
Procedures for assessing the conformity of machinery
1. The manufacturer or his authorised representative shall, in order to certify the conformity of machinery with the provisions of this Directive, apply one of the procedures for assessment of conformity described in paragraphs 2, 3 and 4.
. . .
§127 Conformity assessment of machinery
Article 12 concerns the conformity assessment procedure that must be carried out by the manufacturer of machinery or his authorised representative before placing machinery on the market and/or putting it into service – see §103: comments on Article 5 (1). The conformity assessment procedure is mandatory, however, for certain categories of machinery, the manufacturer can choose between several alternative procedures. The following paragraphs set out the conditions under which the different conformity assessment procedures can be used.
Article 12 (continued)
. . .
2. Where the machinery is not referred to in Annex IV, the manufacturer or his authorised representative shall apply the procedure for assessment of conformity with internal checks on the manufacture of machinery provided for in Annex VIII.
. . .
§128 Categories of machinery not listed in Annex IV
Article 12 (2) sets out the conformity assessment procedure to be used for all categories of machinery other than those listed in Annex IV. The procedure to be followed is the procedure for assessment of conformity with internal checks on the manufacture of machinery, sometimes referred to as "Supplier’s Declaration of Conformity” or “first party attestation”121 – see §395: comments on Annex VIII. This procedure does not involve the intervention of a Notified Body. However, the manufacturer or his authorised representative is free to seek any independent advice or assistance he needs in order to carry out the conformity assessment of the machinery. He may carry out the checks, inspections and tests and inspections needed to assess the conformity of the machinery himself or entrust them to any competent body of his choice. The relevant technical reports shall be included in the technical file – see §392: comments on Annex VII A 1 (a), sixth indent.
It should be noted that there are no Notified Bodies for categories of machinery other than those listed in Annex IV. Manufacturers of non-Annex IV machinery may seek advice or assistance from Bodies that are notified for certain categories of Annex IV machinery. However, in that case, the body is not acting as a Notified Body and must not use the identification number assigned to it by the Commission on any documents relating to such activity – see §133: comments on Article 14.
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Article 12 (continued)
. . .
3. Where the machinery is referred to in Annex IV and manufactured in accordance with the harmonised standards referred to in Article 7(2), and provided that those standards cover all of the relevant essential health and safety requirements, the manufacturer or his authorised representative shall apply one of the following procedures:
- the procedure for assessment of conformity with internal checks on the manufacture of machinery, provided for in Annex VIII;
- the EC type-examination procedure provided for in Annex IX, plus the internal checks on the manufacture of machinery provided for in Annex VIII, point 3;
- the full quality assurance procedure provided for in Annex X.
. . .
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§129 Annex IV machinery designed to harmonised standards that cover all the applicable essential health and safety requirements
Article 12 (3) sets out the three alternative conformity assessment procedures that may be applied to categories of machinery listed in Annex IV designed and constructed in
121 The concept of "Suppliers Declaration of Conformity" is explained in standard EN ISO/IEC 17050-
1:2010 Conformity assessment - Supplier’s Declaration of Conformity - Part 1: General requirements (ISO/IEC 17050-1:2004, corrected version 2007-06-15); however, application of this standard does not confer a presumption of conformity with the requirements of the Machinery Directive.
accordance with harmonised standards. For the procedures set out in Article 12 (3) to be applicable, the following three conditions must be fulfilled:
- the machinery concerned must be in the scope of one or more harmonised Ctype standards, (exception is made for safety components independently placed on the market within the scope of one or more harmonised B-type standards- - see §111), the references of which have been published in the OJEU – see §110: comments on Article 7 (2);
- the harmonised standard or standards concerned must cover all of the essential health and safety requirements that are applicable to the machinery as determined by the risk assessment – see §159: comments on General Principle 1. Note that some harmonised standards do not cover all the EHSRs either due to a warning in the OJEU or by design, in the latter case this will be stated in Annex Z. The manufacturer must therefore check that the standard/s do cover all the applicable EHSR by checking both the most recent publication in the OJEU and Annex Z;
- the machinery must be designed and constructed fully in accordance with the harmonised standards concerned.
When these three conditions are fulfilled, the manufacturer can choose the procedure referred to in Article 12 (3) (a) or one of the alternative procedures referred to in Article 12 (3) (b) and (c).
The procedure referred to in Article 12 (3) (a) - assessment of conformity with internal checks on the manufacture of machinery - is identical to the procedure referred to in Article 12 (2) that is applicable for categories of machinery not listed in Annex IV.
The procedure referred to in Article 12 (3) (b) requires the manufacturer to submit the model of machinery to an EC type-examination by a Notified Body in order to ensure that it complies with the EHSRs that are applicable. The conformity of the machinery subsequently produced according to the model examined by the Notified Body is then assessed by the manufacturer himself by means of internal checks – see §396 to §400: comments on Annex IX, and §395: comments on Annex VIII 3.
The procedure set out in Article 12 (3) (c) requires the manufacturer to have a full quality assurance system covering the design, manufacture, final inspection and testing of machinery. The system must be assessed and approved by a Notified Body to ensure that it is adequate to ensure the design and manufacture of machinery that complies with the EHSRs that are applicable. The Notified Body must also monitor the correct application of the full quality assurance system – see §401 to §407: comments on Annex X.
The manufacturer or his authorised representative in the EU can request an EC typeexamination of a model of machinery or the assessment of a full quality assurance system from any Notified Body of his choice in the EU, provided the Notified Body concerned is notified for the conformity assessment procedure and for the category of machinery concerned – see §133: comments on Article 14. However, a request for an EC type-examination for a given model of machinery or a request for the assessment of a given full quality assurance system can only be lodged with a single Notified Body – see §397: comments on Annex IX 2.1, and §402: comments on Annex X 2.1.
An EC type-examination certificate or a decision approving a full quality assurance system issued by a Notified Body is valid throughout the EU.
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Article 12 (continued)
. . .
4. Where the machinery is referred to in Annex IV and has not been manufactured in accordance with the harmonised standards referred to in Article 7(2), or only partly in accordance with such standards, or if the harmonised standards do not cover all the relevant essential health and safety requirements or if no harmonised standards exist for the machinery in question, the manufacturer or his authorised representative shall apply one of the following procedures:
(a) the EC type-examination procedure provided for in Annex IX, plus the internal checks on the manufacture of machinery provided for in Annex VIII, point 3; (b) the full quality assurance procedure provided for in Annex X.
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§130 Other Annex IV machinery
Article 12 (4) sets out the 2 conformity assessment procedures that may be applied for categories of machinery listed in Annex IV when the one or more of the three conditions for applying Article 12 (3) are not fulfilled. Consequently, the procedures referred to in Article 12 (4) apply in the following cases:
- where harmonised standards covering the type of machinery concerned are not available;
- where the harmonised standards applied by the manufacturer do not cover all the essential health and safety requirements applicable to the machinery concerned;
- where the manufacturer of the machinery concerned has not applied or has only partially applied the relevant harmonised standards.
In such cases, the procedure for assessment of conformity with internal checks on the manufacture of machinery cannot be used and, consequently, one of the two procedures involving a Notified Body must be followed. The manufacturer can still refer to specific clauses of a harmonised standard to prove compliance with one or more requirements of the Directive.
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Article 13
Procedure for partly completed machinery
- The manufacturer of partly completed machinery or his authorised representative shall, before placing it on the market, ensure that:
- the relevant technical documentation described in Annex VII, part B is prepared;
- assembly instructions described in Annex VI are prepared;
- a declaration of incorporation described in Annex II, part 1, Section B has been drawn up.
- The assembly instructions and the declaration of incorporation shall accompany the partly completed machinery until it is incorporated into the final machinery and shall then form part of the technical file for that machinery.
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§131 Procedure for partly completed machinery
Article 13 (1) sets out the procedure to be followed for the placing on the market of partly completed machinery referred to in Article 1 (1) (g) – see §384 and §385: comments on Annex II 1 B, §390: comments on Annex VI, and §394: comments on Annex VII B.
Article 13 (2) aims to ensure that the assembly instructions and the Declaration of Incorporation drawn up by the manufacturer of partly completed machinery are made available to the manufacturer of the final machinery into which the partly completed machinery is incorporated. This is so they can both apply the assembly instructions and include them and the Declaration of Incorporation in the technical file for the final machinery – see §392: comments on the eighth indent of Annex VII A 1 (a).
In general, this implies that the Declaration of Incorporation and a copy of the assembly instructions must be supplied with each item of partly completed machinery. However, in cases where a manufacturer of partly completed machinery supplies a batch of identical products to an identified manufacturer of final machinery, it is not necessary for the manufacturer of the partly completed machinery to supply the Declaration of Incorporation and the assembly instructions with each item, provided he ensures that the manufacturer of the final machinery has received these documents with the first delivery of products belonging to the batch and makes it clear that the Declaration of Incorporation and the assembly instructions apply to all of the items of partly completed machinery belonging to the batch.
Where the partly completed machinery (or part of it) is subject to other EU legislation in addition to the Machinery Directive, the conformity with the other Directives or Regulations concerned must also be declared.
§132 Diagram of the procedures for the placing on the market of machinery and partly completed machinery
The following diagram summarises the procedures set out in Article 12 and 13:
¬ Harmonised standards are not available, the harmonised standards do not cover all the applicable EHSRs or the harmonised standards are not applied or are only partially applied.
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Product category
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Documents
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Procedure
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Colour code: Declaration – marking
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Article 14
Notified bodies
- Member States shall notify the Commission and the other Member States of the bodies which they have appointed to carry out the assessment of conformity for placing on the market referred to in Article 12 (3) and (4), together with the specific conformity assessment procedures and categories of machinery for which these bodies have been appointed and the identification numbers assigned to them beforehand by the Commission. Member States shall notify the Commission and other Member States of any subsequent amendment.
- The Member States shall ensure that the notified bodies are monitored regularly to check that they comply at all times with the criteria set out in Annex XI. The notified body shall provide all relevant information on request, including budgetary documents, to enable the Member States to ensure that the requirements of Annex XI are met.
- Member States shall apply the criteria set out in Annex XI in assessing the bodies to be notified and the bodies already notified.
- The Commission shall publish in the Official Journal of the European Union, for information, a list of the notified bodies and their identification numbers and the tasks for which they have been notified. The Commission shall ensure that this list is kept up to date.
- Bodies meeting the assessment criteria laid down in the relevant harmonised standards, the references of which shall be published in the Official Journal of the European Union, shall be presumed to fulfil the relevant criteria.
. . .
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§133 Notified Bodies
Article 14 sets out the provisions relating to Notified Bodies. Notified Bodies are independent, third-party conformity assessment bodies entrusted with the conformity assessment procedures referred to in Article 12 (3) and (4) for the categories of machinery listed in Annex IV. The term "notified" refers to the fact that such Bodies are notified by the Member States to the Commission and to the other Member States. Before a conformity assessment body is notified, it must be assigned an identification number (with 4 digits) by the Commission. A given Body has a single identification number and may be notified under one or several EU Directives.
Under the Machinery Directive, bodies can only be notified for conformity assessment of the categories of machinery listed in Annex IV. Bodies that have been notified may also provide conformity assessment services to manufacturers of other categories of machinery. However, in such cases, the bodies must make it clear to their customers that they are not acting as Notified Bodies and must not use the identification number assigned to them by the Commission on any documents relating to such activity – see §128: comments on Article 12 (2). It is important that there is no conflict of interest when they carry out work as a Notified Body, so if they undertake consultancy work involving the design of a product that is listed under Annex IV then another Notified Body should be appointed for the conformity assessment process.
The assessment, appointment and monitoring of the Notified Bodies is the exclusive responsibility of the Member States.
The notification is carried out using the Commission's online information system NANDO (New Approach Notified and Designated Organisations). This site lists all of the European Notified Bodies as well as third country bodies designated under formal agreements such as Mutual Recognition Agreements (MRAs), the European Economic Area Agreement (EEA) and Agreements on Conformity Assessment and Acceptance of Industrial Products (ACAAs).
When notifying a body for conformity assessment according to the Machinery Directive, the notifying authority of the Member State concerned must indicate the category of machinery for which the Body has been designated. A Notified Body may be designated to assess the conformity of one or more of the categories of machinery listed in Annex IV.
The notification must also indicate for which conformity assessment procedure or procedures the Body has been designated. A Notified Body may be designated for one or both of the following two procedures referred to in Article 12:
- the EC type-examination procedure - Article 12 (3) (b) and Article 12 (4) (a) – Annex IX;
- the full quality assurance procedure – Article 12 (3) (c) and Article 12 (4) (b) – Annex X.
Before lodging a request for conformity assessment with a Notified Body, it is therefore important to check in NANDO that the Notified Body concerned has been notified according to the Machinery Directive for the category of machinery and for the conformity assessment procedure concerned – see §129: comments on Article 12 (3).
§134 Assessment and monitoring of Notified Bodies
Article 14 (3) refers to the criteria set out in Annex XI to be used when assessing the bodies to be notified – see §408: comments on Annex XI. Member States are strongly encouraged to use accreditation as a means for assessing Notified Bodies. Regulation (EC) No 765/2008 requires each Member State to appoint a single accreditation body to evaluate whether assessment bodies are competent to carry out specific conformity assessment activities. Each national accreditation body is subject to peer evaluation organised by the European Cooperation for Accreditation (EA)[68].
Article 14 (5) refers to the relevant harmonised standards that can be used to assess Notified Bodies and their laboratories. The relevant harmonised standards are EN ISO/IEC 17020, 17021 and 17025[69].
According to Article 14 (2), the Member States must also monitor the Notified Bodies in order to ensure that they continue to fulfil the criteria set out in Annex XI. When accreditation is used for the initial assessment of a Notified Body, the accreditation is usually granted for a limited period of time. The monitoring of the Notified Body can therefore be carried out by means of periodic audits in view of renewal of the accreditation.
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Article 14 (continued)
. . .
6. If a notified body finds that relevant requirements of this Directive have not been met or are no longer met by the manufacturer or that an EC type-examination certificate or the approval of a quality assurance system should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate or the approval issued or place restrictions on it, giving detailed reasons, unless compliance with such requirements is ensured by the implementation of appropriate corrective measures by the manufacturer.
In the event of suspension or withdrawal of the certificate or the approval or of any restriction placed on it, or in cases where intervention by the competent authority may prove necessary, the notified body shall inform the competent authority pursuant to Article 4. The Member State shall inform the other Member States and the Commission without delay.
An appeal procedure shall be available.
. . .
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§135 Withdrawal of certificates or decisions issued by Notified Bodies Article 14 (6) sets out the duties of a Notified Body in the following cases:
- The Notified Body is informed that machinery placed on the market covered by an EC type-examination certificate or by a decision approving a manufacturer's full quality assurance system fails to comply with the applicable essential health and safety requirements or is unsafe.
This may be the case, for example, if the machinery concerned is the subject of a measure notified under the safeguard procedure according to Article 11 or by a measure taken to deal with potentially hazardous machinery according to Article 9.
- The notified Body is informed that the manufacturer is failing to comply with his obligations under an approved full quality assurance system.
1 to 5 – bodies have 2 years before they full supersede the 2011 version); EN ISO/IEC 17025:2005
General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2005); EN ISO/IEC 17025:2005/AC:2006. See Commission communication in the framework of the implementation of the Regulation (EC) No 765/2008 of the European Parliament and of the Council, Decision 768/2008/EC of the European Parliament and of the Council, Regulation (EC) No 761/2001 of the European Parliament and of the Council (Publication of titles and references of harmonised standards). OJ C 136, 16.6.2009, p. 8.
This may be the case, for example, following a periodic audit of the full quality assurance system or following an unannounced visit to check the proper functioning of such a system – see §406: comments on Annex X 3.
The measures to be taken by the Notified Body in such cases depend on the seriousness of the non-conformity and of the risks involved. However, if the appropriate corrective measures are not taken by the manufacturer within the imparted timeframe, the relevant EC type-examination certificate or Decision of approval of a full quality assurance system must be suspended or withdrawn.
When a certificate or decision of approval is suspended or withdrawn, the Notified Body must inform the market surveillance authorities in the Member State in which they are established so that any measures needed to deal with non-compliant or unsafe machinery can be taken. The national authorities shall inform the other Member States and the Commission if action is needed to deal with non-compliant or unsafe machinery outside their territory.
The third paragraph of Article 14 (6) states that an appeal procedure shall be available. A manufacturer must be able to appeal against a decision of a Notified Body to refuse to issue, to suspend, to withdraw or not to renew an EC type-examination certificate - see §399 and §400: comments on Annex IX 5 and 9. A manufacturer must also be able to appeal against a decision not to approve a full quality assurance system, to withdraw or suspend such an approval or to place restrictions on it – see §404 and §406: comments on Annex X 2.3 and 3. The manufacturer must first make a reasoned request to the Notified Body to reconsider its decision. If that fails and if the manufacturer continues to disagree with the decision, he must be able to lodge an appeal. The form of the appeal and the procedure to be followed depends on the national provisions regulating the activity of the Notified Bodies.
Article 14 (continued)
. . .
7. The Commission shall provide for the organisation of an exchange of experience between the authorities responsible for appointment, notification and monitoring of notified bodies in the Member States, and the notified bodies, in order to coordinate the uniform application of this Directive.
. . .
§136 Exchange of experience between the notifying authorities
The exchange of experience between the authorities responsible for assessing and monitoring of the Notified Bodies foreseen in Article 14 (7) is organised in the framework of the Machinery Working Group – see §148: comments on Article 22.
§137 The coordination of Notified Bodies
The exchange of experience between the Notified Bodies is organised in the framework of a European Coordination of Notified Bodies for Machinery, NB-M. The purpose of NBM is to discuss problems arising in the course of the conformity assessment procedures and to harmonise the practice of the Notified Bodies. In some cases, Notified Bodies are represented by a national coordination group set up in their country. Participation in coordination activities is one of the criteria for the notification of bodies – see §408: comments on Annex XI.
NB-M is divided into a number of groups that cover the different categories of machinery listed in Annex IV. These are called Vertical Groups (VGs).
There are currently 13 VGs that meet as necessary to deal with the following subjects:
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VG1
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Woodworking machinery
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VG2
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Meatworking machinery
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VG3
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Presses for cold-working metals
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VG4
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Injection or compression moulding machines
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VG5
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Machines for underground work
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VG6
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Household waste collection skips (RCVs)
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VG7
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Removable transmission shafts
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VG8
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Vehicles servicing lifts
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VG9
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Lifting persons devices
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VG 11
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Safety components
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VG 12
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ROPS and FOPS
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VG 13
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Full quality assurance
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VG 14
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Portable cartridge-operated fixing and other impact machinery
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In addition, NB-M has a Horizontal Committee that supervises and coordinates the work of the Vertical Groups and deals with issues common to all of the Notified Bodies. The Horizontal Committee meets twice a year, under the chairmanship of an elected representative of one of the Notified Bodies. Representatives of the European Commission and of three Member States chosen by the Machinery Working Group take part in these meetings as observers.
The European Commission contributes to the functioning of NB-M by financing the technical secretariat, which prepares the work of the Group, and the administrative secretariat, which organises the meetings and manages the circulation of documents.
NB-M adopts so-called "Recommendations for Use" (RfUs) which provide agreed answers to questions that have been discussed in the Vertical Groups. In general, RfUs are established where no relevant harmonised standard is available or where the relevant harmonised standard does not provide a sufficiently precise answer to a certain question. When a relevant harmonised standard is adopted or when the harmonised standard is revised accordingly, the RfU is withdrawn. The RfUs are approved by the NB-M Horizontal Committee then communicated to the Machinery Working Group for endorsement. The RfUs that have been endorsed by the Machinery Working Group are published on the Commission’s website EUROPA. The RfUs are not legally binding but, once they have been agreed by NB-M and have been endorsed by the Machinery Working Group, they are to be considered as an important reference for ensuring uniform application of the Machinery Directive by the NBs.
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Article 14 (continued)
. . .
8. A Member State which has notified a body shall immediately withdraw its notification if it finds:
(a) that the body no longer meets the criteria set out in Annex XI; or (b) that the body seriously fails to fulfil its responsibilities.
The Member State shall immediately inform the Commission and the other Member States accordingly.
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§138 Withdrawal of notification
Article 14 (8) obliges Member States to withdraw their notification of a body which no longer meets the criteria listed in Annex XI or which seriously fails to fulfil its responsibilities. The obligation to withdraw a notification that is no longer justified is a consequence of the obligation for the Member States to monitor the activity of the bodies they have notified in order to ensure that they are carrying out their tasks correctly – see §134: comments on Article 14 (2).
Article 15
Installation and use of machinery
This Directive shall not affect Member States' entitlement to lay down, in due observance of Community law, such requirements as they may deem necessary to ensure that persons, and in particular workers, are protected when using machinery, provided that this does not mean that such machinery is modified in a way not specified in this Directive.
§139 National regulations on the installation and use of machinery
The Machinery Directive applies to the design, construction, placing on the market or putting into service of machinery – see §71 to §77: comments on Article 2 (h), and §86: comments on Article 2 (k). For these aspects, the Directive ensures the total harmonisation of the regulations in force throughout the EU. In other words, the Member States may not introduce national provisions that go beyond, overlap with or contradict the provisions of the Directive.
Article 15 indicates that Member States remain free to regulate the installation and use of machinery in accordance with the relevant provisions of EU law, providing these regulations do not have the effect of restricting the free movement of machinery that complies with the provisions of the Machinery Directive – see §6: comments on Recital 3, and §107: comments on Article 6 (1).
Thus national regulations on the installation and use of machinery or their application must not lead to the modification of machinery that complies with the Machinery Directive. This presupposes that machinery placed on the market really complies with the requirements of the Directive. If users or the national authorities consider that an item of machinery placed on the market is not sufficiently safe and that the applicable essential health and safety requirements have not been correctly applied, the machinery should be reported to the market surveillance authorities, while the necessary measures are taken to ensure the safety of persons – see §100: comments on Article 4.
The following are some examples of the subjects that may be covered by national rules on the installation and use of machinery:
- the installation of machinery in certain areas, such as, for example, the installation of cranes in urban areas or the installation of wind generators in the countryside;
- the use of mobile machinery in certain areas, such as, for example, the use of offroad vehicles in areas open to the public or the use of certain types of agricultural machinery close to dwellings or public roads;
- the circulation of mobile machinery on public roads;
- the use of machinery at certain times, such as, for example, restrictions on the use of lawnmowers during the weekend;
- the use of certain kinds of machinery by people under a certain age.
§140 National regulations on the health and safety of workers
Particular mention must be made of the national regulations implementing the provisions of the EU Directives relating to health and safety at work. These Directives are based on Article 137 of the EC Treaty (now Article 153 of the TFEU) relating to the protection of workers' health and safety. They set out minimum requirements, which means that Member States remain free to maintain or adopt more stringent requirements if they see fit. Consequently, it is necessary to consult the national regulations in force in each Member State in order to identify the relevant obligations. The most important Directives relating to the use of machinery are:
- Directive 89/391/EEC[70] on the safety and health of workers at work. This is known as the "Framework" Directive, since it sets out the basic obligations of employers and workers relating to health and safety at work and provides the framework for a series of individual Directives dealing with specific aspects of health and safety or specific hazards;
- Directive 2009/104/EC[71] on the use of work equipment by workers at work. This is the second individual Directive adopted under the "Framework" Directive.
Although the concept of work equipment is broader than that of machinery, machinery for professional use constitutes an important category of work equipment. The national regulations implementing the provisions of Directive 2009/104/EC always apply to the use of machinery at work. In this respect, Directive 2009/104/EC can be considered as a measure complementary to the Machinery Directive.
According to Directive 2009/104/EC, employers are required to make available to workers work equipment that is suitable for the work to be carried out and which complies with the provisions of any relevant EU Directive which is applicable to it.[72] Consequently, all new machinery made available to workers must comply with the Machinery Directive and any other EU Directives that may be applicable – see §89 to §92: comments on Article 3.
The provisions of Directive 2009/104/EC are applicable to machinery in service in workplaces. During the lifetime of the machinery, the employer must take the measures necessary to ensure that machinery in service is kept, by means of adequate maintenance, at a level such that it complies with the provisions that were applicable when it was first made available in the undertaking or establishment[73]. This does not mean that the machinery must be maintained in an “as new” condition, since it is subject to wear. But the necessary maintenance must be carried out to ensure that it continues to comply with the applicable health and safety requirements. To do so, the employer must follow the manufacturer’s instructions – see §272: comments on section 1.7.4.2 (r) of Annex I.
Thus machinery that was subject to the provisions of the Machinery Directive when it was first made available must be maintained in a state of conformity with the essential health and safety requirements of the Machinery Directive that were applied when it was first placed on the market or put into service.
This also applies whenever machinery is modified by the user during the course of its lifetime, unless the modifications are so substantial that the modified machinery must be considered as new machinery and be subject to a new conformity assessment according to the Machinery Directive – see §72: comments on Article 2 (h).
Annex I of Directive 2009/104/EC sets out minimum technical requirements applicable to work equipment in service. These minimum requirements are applicable to machinery put into service before the Machinery Directive became applicable[74].They are not applicable to machinery placed on the market or put into service according to the Machinery Directive.
Directive 2009/104/EC also includes provisions relating to:
- the initial inspection of work equipment the safety of which depends on installation conditions, after installation and before being put into service;
- the inspection of such work equipment after assembly at a new site or in a new location, for example when tower cranes are moved to a new site;
- periodic and special inspections and, where appropriate, testing of work equipment exposed to conditions causing deterioration which is liable to result in dangerous situations[75].
In the case of lifting machinery, the initial inspections, for which the employer is responsible, must be distinguished from the measures to check the fitness for purpose of the machinery, which are the responsibility of the machinery manufacturer – see §350 to §352: comments on section 4.1.3 of Annex I.
Other provisions of Directive 2009/104/EC deal with:
- the restriction of the use and/or the maintenance of work equipment involving a specific risk to designated workers;
- taking account of ergonomic principles;
- information, instructions and training for workers on the use of work equipment; consultation of workers and workers' participation[76].
In addition, Annex II of Directive 2009/104/EC sets out specific rules for the use of certain categories of work equipment, including mobile work equipment, work equipment for lifting goods and work equipment for lifting persons – see §10: comments on Recital 7.
The instructions supplied by the manufacturer with machinery constitute an essential tool to enable employers to apply the provisions implementing Directive 2009/104/EC – see §254: comments on section 1.7.4 of Annex I.
Article 16
CE marking
- The CE conformity marking shall consist of the initials ‘CE’ as shown in Annex III.
- The CE marking shall be affixed to the machinery visibly, legibly and indelibly in accordance with Annex III.
- The affixing on machinery of markings, signs and inscriptions which are likely to mislead third parties as to the meaning or form of the CE marking, or both, shall be prohibited. Any other marking may be affixed to the machinery provided that the visibility, legibility and meaning of the CE marking is not thereby impaired.
§141 The CE marking
The provisions on the CE marking of machinery set out in the Machinery Directive apply together with the provisions of Regulation (EC) 765/2008 setting out the General Principles of the CE marking which apply in a complementary way. The following comments are based on Article 16 and Annex III of the Machinery Directive and on Article 2 (20) and Article 30 of Regulation (EC) 765/2008. The obligations relating to the CE marking apply to the manufacturer, his authorised representative or the person responsible for placing the machinery on the market – see §78 to §85: comments on
Article 2 (i) and (j).
Regulation (EC) 765/2008 defines 'CE marking' as a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in Community harmonisation legislation providing for its affixing. By affixing or having affixed the CE marking, the manufacturer indicates that he takes responsibility for the conformity of the product.
- the CE marking consists of the initials ‘CE’ with the graphic form shown in Annex
III;
- the various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm. The minimum dimension may be waived for small-scale machinery;
- the CE marking must be affixed to the machinery visibly, legibly and indelibly in the immediate vicinity of the name of the manufacturer or his authorised representative, using the same technique – see §250: comments on section 1.7.3 of Annex I;
- where the full quality assurance procedure referred to in Article 12 (3) (c) and 12 (4) (b) has been applied, the CE marking must be followed by the identification number of the Notified Body that has approved the manufacturer's full quality assurance system – see §133: comments on Article 14.
The CE marking shall be the only marking which attests the conformity of the product with the applicable requirements of the relevant EU harmonisation legislation providing for its affixing. Article 16 (3) requires the Member States to forbid the affixing on machinery of markings, signs or inscriptions which are likely to mislead third parties as to the meaning or form of the CE markings or both.
Markings which are likely to mislead third parties as to the form of the CE marking might be, for example, the letters 'EC' or 'EEC', with a graphic form similar to that shown in Annex III, or the initials 'CE' with a graphic form different from that shown in Annex III. Markings which are likely to mislead third parties as to the meaning of the CE marking are markings, other than the CE marking, that signify that the machinery complies with the applicable EU legislation.
The measures to be taken in cases of non-conformity of marking are set out in Article 17.
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Article 17
Non-conformity of marking
- Member States shall consider the following marking not to conform:
- the affixing of the CE marking pursuant to this Directive on products not covered by this Directive;
- the absence of the CE marking and/or the absence of the EC declaration of conformity for machinery;
- the affixing on machinery of a marking, other than the CE marking, which is prohibited under Article 16 (3).
- Where a Member State ascertains that marking does not conform to the relevant provisions of this Directive, the manufacturer or his authorised representative shall be obliged to make the product conform and to put an end to the infringement under conditions fixed by that Member State.
- Where non-conformity persists, the Member State shall take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market in accordance with the procedure laid down in Article 11.
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§142 Non conformity of marking
The safeguard clause set out in Article 11 sets out the measures to be taken when machinery bearing the CE marking is discovered to be unsafe. Article 17 sets out the measures to deal with cases of formal non-conformity with the provisions of the Machinery Directive, where there is no indication that the machinery concerned is unsafe. These measures are in line with the obligation of the Member States to ensure the correct implementation of the regime governing the CE marking and to take appropriate action in the event of improper use of the marking set out in Article 30 (6) of Regulation (CE) 765/2008.
Article 17 (1) defines the three cases that are considered to constitute non-conformity of marking. Article 17 (2) states that Member States shall take the necessary measures to require economic operators to put an end to such infringements. The nature of the measures is left to the discretion of the Member States. Such measures do not have to be notified to the Commission or to the other Member States. The penalties for infringements against the provisions of the Machinery Directive must include penalties for non-conformity of marking – see §150: comments on Article 23.
Article 17 (3) sets out the procedure to be followed in case the measures taken to put an end to the infringements referred to in Article 17 (1) are not effective. In that case, the safeguard procedure set out in Article 11 must be followed.
Article 18
Confidentiality
- Without prejudice to existing national provisions and practices in the area of confidentiality, Members States shall ensure that all parties and persons concerned by the application of this Directive are required to treat as confidential information obtained in the execution of their tasks. More particularly business, professional and trade secrets shall be treated as confidential, unless the divulging of such information is necessary in order to protect the health and safety of persons.
- The provisions of paragraph 1 shall not affect the obligations of the Member States and the notified bodies with regard to mutual exchange of information and the issuing of warnings.
- Any decisions taken by the Member States and by the Commission in accordance with Articles 9 and 11 shall be published.
§143 Confidentiality and transparency
The parties and persons concerned by the provisions set out in Article 18 include the administrations of the Member States, the Commission and the Notified Bodies. In particular, the authorities of the Member States and the services of the Commission may require manufacturers to communicate elements of the technical file for machinery or of the relevant technical documentation for partly completed machinery which contain professional and trade secrets. The officials of the public administrations or agencies concerned and any other bodies or institutions acting on their behalf must respect the confidentiality of such information obtained or received in the course of application of the Machinery Directive. Similarly, Notified Bodies must respect the confidentiality of information obtained or received while carrying out the conformity assessment procedures for which they are responsible – see §408: comments on Annex XI 7.
Article 18 (2) indicates that the obligation of confidentiality does not prevent the transmission of information between the Member States and to the Commission in the framework of the cooperation foreseen in Article 19 (Machinery AdCo Group) or to using the internal section of ICSMS to which access is appropriately restricted. The obligation of confidentiality does not apply to the communication of information between the Notified Bodies and to the communication of information by the Notified Bodies to the Member States – see §135: comments on Article 14 (6), §399: comments on Annex IX 5 and 7, and §407: comments on Annex X 4.
The confidentiality obligation does not preclude the issuing of public warnings when this is necessary in order to protect the health and safety of persons.
Article 18 (3) sets out a particular requirement for transparency relating to any decisions taken by the Member States and by the Commission in accordance with Articles 9 and 11. The decisions concerned include:
- the measures taken by the Commission requiring Member States to prohibit or restrict the placing on the market of potentially hazardous machinery according to Article 9 (1);
- the measures taken by the Member States to withdraw from the market, to prohibit the placing on the market and/or putting into service or to restrict the free movement of machinery that is liable to compromise the health and safety of persons and, where appropriate, domestic animals, property, or the environment for pesticide machinery, according to Article 11 (1) (the safeguard clause);
- decisions taken by the Commission on safeguard clauses according to Article 11
(3).
Article 19
Cooperation between Member States
- Member States shall take the appropriate measures to ensure that the competent authorities referred to in Article 4(3) cooperate with each other and with the Commission and transmit to each other the information necessary to enable this Directive to be applied uniformly.
- The Commission shall provide for the organisation of an exchange of experience between the competent authorities responsible for market surveillance in order to coordinate the uniform application of this Directive.
§144 Machinery AdCo Group
Article 19 (1) requires the Member States to organise cooperation between the national market surveillance authorities and to transmit to each other the necessary information. Cooperation is essential in this area since, while CE-marked machinery is able to move freely within the single market, surveillance is carried out by each of the Member States.
Article 19 (2) gives the Commission the responsibility of providing for the organisation of an exchange of experience between the market surveillance authorities.
The practical application of Article 19 is carried out in the framework of the Machinery Administrative Cooperation Group (Machinery AdCo Group). This is a forum for the exchange of information between the market surveillance authorities of the Member States and the Commission. The Machinery AdCo Group usually meets twice a year and is chaired in turn by representatives of the Member States. The meetings are restricted to the representatives of the Member States and the Commission and the proceedings and documents of the AdCo Group are confidential, since they frequently refer to specific cases under investigation. However other stakeholders may be invited to take part in AdCo meetings as experts, to an “open” section of the meeting only, to contribute on particular topics when such confidential information is not discussed.
Where the Machinery AdCo reaches a view on the interpretation or added guidance on the Directive, this is then transmitted to the Machinery Working Group for its discussion and agreement. If approved by the Machinery Working Group, the Commission will either integrate the agreed changes in the guide or publish them on the EUROPA machinery website.
The main activities of the Machinery AdCo Group are:
- sharing information and experience of market surveillance activity;
- promoting best practices and optimising the use of resources;
- ensuring that corrective measures to deal with non-compliant and unsafe machinery are applied in all Member States;
- providing information on the progress and outcome of the safeguard procedure and following-up safeguard clause decisions;
- following-up decisions on specific measures to deal with potentially hazardous machinery;
- planning and organising joint market surveillance projects.
Article 20
Legal remedies
Any measure taken pursuant to this Directive which restricts the placing on the market and/or putting into service of any machinery covered by this Directive shall state the exact grounds on which it is based. Such a measure shall be notified as soon as possible to the party concerned, who shall at the same time be informed of the legal remedies available to him under the laws in force in the Member State concerned and of the time limits to which such remedies are subject.
§145 Reasons for decisions and appeals
Article 20 applies to any measures taken by the authorities of the Member States restricting the placing on the market and/or the putting into service of machinery, whether they are taken on the basis of Article 11 (the safeguard clause), Article 9 (specific measures to deal with potentially hazardous machinery) or Article 17 (nonconformity of marking). The Member State is required to have a procedure in place by which an economic operator can have access to a legal remedy in case of dispute. There should be clear time limits that the operator has to raise such a case against a restrictive action.
Article 21
Dissemination of information
The Commission shall take the necessary measures for appropriate information concerning the implementation of this Directive to be made available.
§146 Information sources
Information relevant to the implementation of the Machinery Directive is publicly available online on the machinery pages of the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG Growth) section of the Commission's website EUROPA.
In particular, the following information is available on EUROPA:
- the legal text and the consolidated text of the Machinery Directive;
- a list of contact points in the Member States for implementation of the Directive;
- the list of references of harmonised standards for machinery;
- the list of Notified Bodies for machinery;
- the Recommendations for Use adopted by the European coordination of Notified Bodies for Machinery (NB-M) that have been endorsed by the Machinery Working Group;
- guidance documents approved by the Machinery Working Group and the present Guide to application of Directive 2006/42/EC;
- the consolidated minutes, including decisions, of all the meetings of the Machinery Working Group held since 1997.
Article 22 [77]
Committee
- The Commission shall be assisted by a committee, hereinafter referred to as the ‘Committee’.
- Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
- Where reference is made to this paragraph, Articles 5a(1) to (4), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
§147 The Machinery Committee
Article 22 foresees the setting up of the Committee, called the Machinery Committee, which is composed of representatives of the Member States and chaired by a representative of the Commission. The Committee adopts its own rules of procedure on the basis of standard rules published in the OJEU. The European Parliament is informed of the agendas of the meetings of the Committee and of any draft measures that are submitted to it and receives the results of voting and summary records of the meetings.
The Machinery Committee has two distinct roles:
The advisory role of the Machinery Committee, set out in Article 8 (2), is to advise the
Commission on any appropriate measure connected with the practical application of the Machinery Directive, including measures necessary to ensure cooperation of Member States with each other and with the Commission as provided for in Article 19 (1). The measures concerned cannot involve the amendment of the Directive or the adoption of Decisions supplementing the provisions of the Directive. Therefore, these measures consist mainly in providing guidance on the correct and uniform application of the provisions of the Directive.
The regulatory role of the Machinery Committee is to give its opinion on measures proposed by the Commission, which amend or supplement the provisions of the Directive. According to Article 8 (1) (a) and (b), only two subjects can be the subject of such measures:
- updating of the indicative list of safety components in Annex V – see §42: comments on Article 2 (c);
- restriction of the placing on the market of potentially hazardous machinery – see §118: comments on Article 9.
The opinion of the Machinery Committee is expressed by means of votes of the representatives of the Member States within the Committee, weighted as for votes of the Council according to Article 205 of the EC Treaty (now Article 238 of the TFEU).
Before such measures are adopted by the Commission, they are submitted to the European Parliament and the Council for scrutiny. The European Parliament or the Council may oppose the draft measures proposed by the Commission on the grounds that they exceed the implementing powers provided for in the Directive, that they are not compatible with the aim or the content of the Directive or do not respect the principles of subsidiarity or proportionality. In case of such opposition, the Commission can submit an amended draft or make a legislative proposal. If there is no opposition from the European Parliament and the Council within three months, the Commission adopts the measure.
§148 The Machinery Working Group
The Machinery Working Group is set up by the Machinery Committee in order to allow observers from industry, users (workers and consumers representation organisations) standardisation and the Notified Bodies to take part in the discussion of problems relating to the practical application of the Machinery Directive. In practice, the Machinery Working Group is the most frequently used forum to discuss the application of the Directive at EU level. Like the Machinery Committee, the Machinery Working Group is chaired by a representative of the Commission and composed of representatives of the Member States. Representatives of EFTA countries, candidate countries and countries with formal agreements with the EU are also present as observers.
Associations of machinery manufacturers at European level participate as observers and are invited to attend meetings in order to present information and views on specific issues that are under discussion. Representatives of the European standardisation organisations are also present to provide information and to respond to the questions raised by the Member States relating to standards. The Notified Bodies are represented by the European Coordination of Notified Bodies for Machinery (NB-M) which reports on the work of the Coordination, takes note of the opinion of the Machinery Working Group on the Recommendations for Use submitted to the Working Group for endorsement and submits questions to the Working Group relating to the interpretation of the Directive. Trades unions and representatives of consumer protection organisations are also invited to express the views of the final users of machinery.
The topics most frequently discussed by the Machinery Working Group are:
- clarification of the scope of the Directive and the conformity assessment procedures with respect to particular categories of products;
- concerns relating to the development of harmonised standards for machinery;
- opinions on formal objections against harmonised standards – see §120: comments on Article 10.
The Machinery Working Group meets twice or three times a year in Brussels. Working documents for the meetings of the Machinery Working Group are circulated to members of the Group on the Machinery Directive section of the Commission online information system CIRCABC. Organisations representing machinery stakeholder at European level have access to these documents. Other stakeholders can request the documents from their respective representative organisations. Care should be taken not to take the positions expressed in working documents or discussion papers as representing the views of the Commission or of the Machinery Working Group.
The minutes of meetings of the Machinery Working Group are published on the machinery pages of the Commission's website EUROPA, once they have been corrected and approved at the following meeting.
§149 Diagram of institutions dealing with the Machinery Directive
The following diagram indicates the roles of the different institutions, entities and groups involved in proposing, adopting, transposing, applying and enforcing the Machinery Directive:
Article 23
Penalties
Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by 29 June 2008 and shall notify it without delay of any subsequent amendment affecting them.
§150 Penalties for infringements against the provisions of the Directive
The national provisions implementing the Machinery Directive must be legally binding and infringements against those provisions must therefore be sanctioned by appropriate penalties.
The possible infringements may include the following:
- failure to apply the applicable conformity assessment procedure for machinery – see §127 to §130: comments on Articles 12;
- failure to apply the procedure for partly completed machinery – see §131:
comments on Article 13;
- non-conformity of marking – see §142: comments on Article 17;
- failure of machinery to comply with the essential health and safety requirements set out in Annex I;
- missing or incomplete technical file – see §103: comments on Article 5, and §391 to §393: comments on Annex VII A;
- missing or incomplete instructions (including the necessary translation) – see §103: comments on Article 5, and §254 to §256: comments on section 1.7.4 of Annex I;
- failure to comply with the measures foreseen in Article 11 (safeguard clause) and Article 9 (specific measures to deal with potentially hazardous machinery).
It is up to each Member State to fix the type and the level of the penalties for such infringements. Article 23 states that the penalties must be effective, proportionate and dissuasive, in line with the Jurisprudence of the European Court of Justice.
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Article 24
Amendment of Directive 95/16/EC
Directive 95/16/EC is hereby amended as follows:
- in Article 1, paragraphs 2 and 3 shall be replaced by the following:
- ‘For the purposes of this Directive, “lift” shall mean a lifting appliance serving specific levels, having a carrier moving along guides which are rigid and inclined at an angle of more than 15 degrees to the horizontal, intended for the transport of:
— persons,
— persons and goods,
— goods alone if the carrier is accessible, that is to say a person may enter it without difficulty, and fitted with controls situated inside the carrier or within reach of a person inside the carrier.
Lifting appliances moving along a fixed course even where they do not move along guides which are rigid shall be considered as lifts falling within the scope of this Directive.
A “carrier” means a part of the lift by which persons and/or goods are supported in order to be lifted or lowered.
- This Directive shall not apply to:
— lifting appliances whose speed is not greater than 0,15 m/s,
— construction site hoists,
— cableways, including funicular railways,
— lifts specially designed and constructed for military or police purposes,
— lifting appliances from which work can be carried out,
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— mine winding gear,
— lifting appliances intended for lifting performers during artistic performances,
— lifting appliances fitted in means of transport,
— lifting appliances connected to machinery and intended exclusively for access to workstations including maintenance and inspection points on the machinery,
— rack and pinion trains,
— escalators and mechanical walkways.’;
2. in Annex I, point 1.2 shall be replaced by the following:
1.2. ‘Carrier
The carrier of each lift must be a car. This car must be designed and constructed to offer the space and strength corresponding to the maximum number of persons and the rated load of the lift set by the installer.
Where the lift is intended for the transport of persons, and where its dimensions permit, the car must be designed and constructed in such a way that its structural features do not obstruct or impede access and use by disabled persons and so as to allow any appropriate adjustments intended to facilitate its use by them.’
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§151 The borderline between the Machinery Directive and the Lifts Directive
Article 24 of Directive 2006/42/EC introduces an amendment to the Lifts Directive 95/16/EC (replaced by Directive 2014/33/EU from 20 April 2016) with the purpose of better defining the borderline with the Machinery Directive – see §28: comments on Recital 27.
On the one hand, Article 24 (1) modifies the definition of 'lift' given in Article 1 (2) of the Lifts Directive, replacing the term ‘car’ with the term 'carrier'. This implies that the nature of the carrier is not a criterion for application of the Lifts Directive. At the same time, Article 24 (2) modifies the essential health and safety requirement set out in section 1.2 of Annex I to the Lifts Directive in order to specify that the carrier of lifts subject to that Directive must be a car. It should also be noted that section 3.1 of Annex I to the Lifts Directive requires lift cars to be completely enclosed.
On the other hand, Article 24 (1) modifies the list of exclusions set out in Article 1 (3) of the Lifts Directive, adding the exclusion of lifting appliances whose speed is not greater than 0,15 m/s. Consequently, low-speed lifts are subject to the Machinery Directive – see §344: comments on section 4.1.2.8 and §377: comments on section 6.4 of Annex I.
With respect to the modified list of exclusions from the Lifts Directive, the following items should also be noted:
Construction site hoists are excluded from the scope of the Lifts Directive. They are no longer excluded from the scope of Directive 2006/42/EC and are thus subject to the Machinery Directive as from 29th December 2009 – see §8: comments on Recital 5.
The following are excluded from the Lifts Directive and are subject to the Machinery Directive:
- lifting appliances from which work can be carried out;
- lifting appliances fitted in means of transport;
- lifting appliances connected to machinery and intended exclusively for access to workstations including maintenance and inspection points on the machinery; escalators and mechanical walkways.
Cableways are all excluded from the scope of the Lifts Directive. In accordance with Article 3, while the Machinery Directive is not applicable to cableways designed to carry persons that are covered by the Cableways Directive 2000/9/EC, it does apply to certain cableways that are outside or excluded from the scope of the Cableways Directive – see §90: comments on Article 3.
The following are excluded from both the Lifts Directive and the Machinery Directive:
- lifts specially designed and constructed for military or police purposes – see §59: comments on Article 1 (2) (g);
- mine winding gear – see §61: comments on Article 1 (2) (i);
- lifting appliances intended for lifting performers during artistic performances – see §62: comments on Article 1 (2) (j);
- rack and pinion trains on rail networks – see §57: comments on the fifth indent of Article 1 (2) (e).
Article 25
Repeal
Directive 98/37/EC is hereby repealed as from 29 December 2009. [78]
References made to the repealed Directive shall be construed as being made to this Directive and should be read in accordance with the correlation table in Annex XII.
§152 Repeal of Directive 98/37/EC
Directive 2006/42/EC replaced Directive 98/37/EC. Directive 98/37/EC was repealed on 29th December 2009, at which date the provisions of Directive 2006/42/EC became applicable.
The second paragraph of Article 25 means that from 29th December 2009, references to the Machinery Directive in other EU legislation remain valid and shall be understood as references to Directive 2006/42/EC. Where such references are made to specific provisions of the Directive, the references shall be read as referring to the equivalent provisions indicated in the correlation table given in Annex XII. Such references are updated when the legislation concerned is revised.
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Article 26
Transposition
- Member States shall adopt and publish the provisions necessary to comply with this Directive by 29 June 2008 at the latest. They shall forthwith inform the Commission thereof.
They shall apply those provisions with effect from 29 December 2009.
When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
- Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive, together with a table showing how the provisions of this Directive correspond to the national provisions adopted.
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§153 Transposition and application of the provisions of the Directive
EU Directives are addressed to the Member States who are thereby instructed to adopt the necessary provisions transposing them into national law. It is these national provisions that create binding obligations for economic operators. According to Article 288 of the TFEU (former Article 249 EC), the Directive is binding as to the result to be achieved but leaves to the national authorities the choice of form and methods. However, since the Machinery Directive is based on Article 95 of the EC Treaty (now Article 114 of the TFEU) that foresees measures to harmonise provisions laid down by law, regulation or administrative action in Member States which have as their object the establishment and functioning of the internal market, the latitude given to the Member States is, in practice, rather limited. In particular, the essential health and safety requirements for the design and construction of machinery and the conformity assessment procedures applicable must be the same in all the Member States.
The Member States were given 2 years following the entry into force of the Directive to adopt the necessary provisions. These provisions become applicable eighteen months later, on 29th December 2009. Until that date, Directive 98/37/EC continued to apply.
The references of the texts transposing the provisions of the Directive into the national law of the Member States, that have been communicated to the Commission according to the obligation set out in Article 26 (2), are presented on the EUR-Lex website[79].
Article 27
Derogation
Until 29 June 2011 Member States may allow the placing on the market and the putting into service of portable cartridge operated fixing and other impact machinery which are in conformity with the national provisions in force upon adoption of this Directive.
§154 Transition period for portable cartridge operated fixing and other impact machinery
As a general rule, since manufacturers have a period of three and a half years between the entry into force of Directive 2006/42/EC and the application of its provisions during which to adapt their products where necessary, it was not considered necessary to foresee a transition period. However, by way of derogation to the general rule, Article 27 foresees a transition period of eighteen months for portable cartridge operated fixing machinery and other portable cartridge operated impact machinery during which Member States may allow the placing on the market of products that comply with the national provisions in force previously. These national provisions are either those implementing the Convention of 1st July 1969 on the Reciprocal Recognition of Proofmarks on Small Arms (the CIP convention), in the case of Member States that are signatories to that Convention, or, in other Member States, existing national regulations – see §9: comments on Recital 6.
It should be noted that the transition period was a facility open to Member States, not an obligation. Consequently, portable cartridge operated fixing machinery and other portable cartridge operated impact machinery that complied with the Machinery Directive benefited for free movement in the European Union from 29th December 2009. Such machinery that complied with the national provisions in force previously could only be placed on the market in those Member States that allow this. As from 29 June 2011, all such machinery must comply with the Machinery Directive.
Article 28
Entry into force
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
§155 Date of entry into force of the Directive
Article 28 sets out the date of entry into force of Directive 2006/42/EC. Since the
Directive was published in the OJEU on 9th June 2006, it entered into force on 29th June 2006. The date of entry into force is the date at which the Directive acquires a legal existence and should not be confused with the date of application of the provisions of the Directive which is 29th December 2009 – see §153: comments on Article 26 (1).
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Article 29
Addressees
This Directive is addressed to the Member States.
Done at Strasbourg, 17 May 2006.
For the European Parliament
The President
J. BORRELL FONTELLES
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For the Council
The President
H. WINKLER
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§156 Addressees and signatories of the Directive
The Directive is addressed to the Member States, since the transposition of the provisions of the Directive into national law is necessary in order to create binding legal obligations for the economic operators.
The Directive is signed by the Presidents of the European Parliament and of the Council since it was adopted by these Institutions according to the co-decision procedure foreseen in Article 251 of the EC Treaty (now referred to as the ordinary legislative procedure in Article 294 of the TFEU) – see §2: comments on the citations.
[1] The risk assessment carried out by the manufacturer, preceding the conformity assessment.
[2] The risk assessment carried out by the manufacturer, preceding the conformity assessment.
[3] See §416: Interchangeable equipment for lifting persons and equipment used with machinery designed for lifting goods for the purpose of lifting persons.
[4] EN 13814:2004 Fairground and amusement park machinery and structures - Safety; EN 13782:2005 Temporary structures - Tents - Safety.
[5] Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation. OJ L 159, 29.06.1996 p. 1; Council Directive 2003/122/Euratom of 22 December 2003 on the control of highactivity sealed radioactive sources and orphan sources. OJ L 346, 31.12.2003, p. 57.
[6] Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles. OJ L 263, 9.10.2007, p. 1.
[7] OJ L 124, 9.5.2012, p. 1.
[8] OJ L 170, 30.6.2009, p.1
[9] Decision of the Machinery Working Group on 5 November 2014.
[10] Decision of the Machinery Working Group on 23 March 2015.
[11] OJ L191, 18.7.2008, p. 1.
[12] OJ L 46 of 17/2/1997, p. 25.
[13] OJ L 254, 23/9/2002, p. 1.
[14] OJ L 96, 29.3.2014, p. 357.
[16] OJ L 169, 12.7.1993, p. 1.
[17] Machinery first placed on the market in countries that subsequently acceded to membership of the European Union is considered as having been placed on the market in the EU.
[18] See Council Regulation (EEC) No 2913/92 establishing the Community customs code.
[19] The EU has "Free Zones" which allow for temporary storage of goods prior to being exported or reexported from the customs territory of the EU or brought into another part of the customs territory of the EU – see Articles 155 to 161 of Regulation (EC) No 450/2008 of the European Parliament and of the
Council of 23 April 2008 laying down the Community Customs Code (Modernised Customs Code). OJ L 145, 4.6.2008, p. 1. Zone are subject to customs supervision and do not benefit from the free circulation in the internal market. Before benefiting from the free circulation in the internal market, these goods must be declared for release for free circulation. That entails application of commercial policy measures, completion of the other formalities laid down in respect of the importation of goods and the charging of any duties legally due.
[20] Article 2 (6) of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93.
[21] Judgement of the ECJ, 8th September 2005, Case C-40/04.
[23] OJ L 285, 31.10.2009, p. 10.
[24] Article 4(1) was amended by Directive 2009/127/EC of the European Parliament and of the Council of 21 October 2009 amending Directive 2006/42/EC with regard to machinery for pesticide application. OJ L 310, 25.11.2009, p. 29.
[25] Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93. OJ L 218, 13.8.2008, p. 30.
[26] See Article 15 (2) of Regulation (EC) No 765/2008.
[27] See Article 2 (17) of Regulation (EC) No 765/2008.
[28] See Article 2 (18) of Regulation (EC) No 765/2008.
[29] See Article 19 (4) of Regulation (EC) No 765/2008.
[30] See Article 19 (1) of Regulation (EC) No 765/2008.
[31] See Article 18 (4) of Regulation (EC) No 765/2008.
[32] See Article 17 (2) of Regulation (EC) No 765/2008.
[33] See Article 16 (3) of Regulation (EC) No 765/2008.
[34] See Article 18 (1) of Regulation (EC) No 765/2008.
[35] See Article 19 (1) of Regulation (EC) No 765/2008.
[36] See Article 18 (2) of Regulation (EC) No 765/2008.
[37] Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety. OJ L 11, 15.1.2002, p. 4.
[38] See Article 18 (5) and (6) of Regulation (EC) No 765/2008.
[39] See Articles 24, 25 and 26 of Regulation (EC) No 765/2008.
[41] See Article 2 (15) of Regulation (EC) No 765/2008.
[42] See Article 2 (14) and Article 20 of Regulation (EC) No 765/2008.
[43] See Article 19 (2) of Regulation (EC) No 765/2008.
[44] See Article 22 (4) of Regulation (EC) No 765/2008.
[45] See Article 1 (2) (b) of Directive 2001/95/EC and Article 15 (3) of Regulation (EC) No 765/2008.
[46] See Article 5 (2) of Directive 2001/95/EC.
[47] See Article 5 (3) of Directive 2001/95/EC.
[48] See Article 8 of Directive 2001/95/EC.
[49] See Article 27 (1) of Regulation (EC) No 765/2008.
[50] See Article 27 (2) of Regulation (EC) No 765/2008.
[51] See Article 29 (5) of Regulation (EC) No 765/2008.
[52] See Article 27 (3) of Regulation (EC) No 765/2008.
[53] See Articles 28 and 29 of Regulation (EC) No 765/2008.
[54] See clause 6.8 "Verification of the safety requirements and/or protective/risk reduction measures" of CEN Guide 414:2004 Safety of machinery - Rules for the drafting and presentation of safety standards.
[59] ISO/TR 22100-1:2015 Safety of machinery - Relationship with ISO 12100 - Part 1: How ISO 12100 relates to type-B and type-C standards. Expected to be taken over as CEN/TR 22100-1.
[60] EN ISO 12100:2010 Safety of machinery - General principles for design - Risk assessment and risk reduction (ISO 12100-1:2010).
[61] Further practical guidance is provided by ISO/TR 22100-1:2015 Safety of machinery - Relationship with ISO 12100 - Part 1: How ISO 12100 relates to type-B and type-C standards. Expected to be taken over as CEN/TR 22100-1.
[62] Article 8 was amended by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny (PRAC) - Adaptation to the regulatory procedure with scrutiny - Part Four. OJ L 188, 18.7.2009, p.14.
[63] Article 9 (3) was amended by Regulation (EC) No 596/2009 of the European Parliament and of the
Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny (PRAC) - Adaptation to the regulatory procedure with scrutiny - Part Four. OJ L 188, 18.7.2009, p.14.
[64] Commission Decision of 19 January 2012 requiring Member States to prohibit the placing on the market of flail-type cutting attachments for portable hand-held brush cutters. OJ L 18, 21.1.2012, p. 5.
[65] Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation (OJ L 316, 14.11.2012, p. 12) lays down procedures, among others, for objections to standards and sets up a committee to consider these. It took over this function with amendments (deletions) to Directive 98/34/EC.
[66] Article 11 was amended by Directive 2009/127/EC of the European Parliament and of the Council of 21 October 2009 amending Directive 2006/42/EC with regard to machinery for pesticide application. OJ L 310, 25.11.2009, p. 29.
[67] See Articles 20 and 22 of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93. OJ L 218, 13.8.2008, p.30.
[68] Regulation (EC) No 765/2008, Articles 3 to 14.
[69] EN ISO/IEC 17020:2012 General criteria for the operation of various types of bodies performing inspection: EN ISO/IEC 17021:2011 Conformity assessment - Requirements for bodies providing audit and certification of management systems (Revised in June 2015 as a family of five standards 17021:2015-
[70] Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work. OJ L 183, 29.6.1989.
[71] Directive 2009/104/EC of the European Parliament and of the Council of 16 September 2009
concerning the minimum safety and health requirements for the use of work equipment by workers at work
(second individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC). OJ L 260, 3.10.2009, p. 5. Directive 2009/104/EC is a codified version of Directive 89/655/EEC and amending Directives 95/63/EEC, 2001/45/EC and 2007/30/EC.
[72] See Directive 2009/104/EC, Articles 4 (1) (a).
[73] See Directive 2009/104/EC, Article 4 (2).
[74] See Directive 2009/104/EC, Article 4 (1) (a) (ii) and (b).
[75] See Directive 2009/104/EC, Article 5.
[76] See Directive 2009/104/EC, Articles 6 to 10.
[77] Article 22 was amended by Regulation (EC) No 596/2009 of the European Parliament and of the
Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny (PRAC) - Adaptation to the regulatory procedure with scrutiny - Part Four. OJ L 188, 18.7.2009, p.14.
[78] Subject to a corrigendum published in OJ L 76, 16.3.2007, p. 35.
