Guide to application of the Machinery Directive 2006/42/EC

Guide to application of the Machinery Directive 2006/42/EC

 

Introduction to the 2nd Edition

Directive 2006/42/EC is a revised version of the Machinery Directive, the first version of which was adopted in 1989. The new Machinery Directive has been applicable since 29th December 2009. The Directive has the dual aim of harmonising the health and safety requirements applicable to machinery on the basis of a high level of protection of health and safety, while ensuring the free circulation of machinery on the EU market. The revised Machinery Directive does not introduce radical changes compared with the previous versions. It clarifies and consolidates the provisions of the Directive with the aim of improving its practical application.

While the revised Machinery Directive was being discussed by the Council and the European Parliament, the Commission agreed to prepare a new Guide to its application. The purpose of the Guide is to provide explanations of the concepts and requirements of Directive 2006/42/EC in order to ensure uniform interpretation and application throughout the EU. The Guide also provides information about other related EU legislation. It is addressed to all of the parties involved in applying the Machinery Directive, including machinery manufacturers, importers and distributors, Notified Bodies, standardisers, occupational health and safety and consumer protection agencies and officials of the relevant national administrations and market surveillance authorities. It may also be of interest to lawyers and to students of EU law in the fields of the internal market, occupational health and safety and consumer protection.

The Guide was endorsed by the Machinery Committee on 2 June 2010.

It should be stressed that only the Machinery Directive and the texts implementing its provisions into national law are legally binding.

The 2nd Edition of the Guide was completed with comments on Annexes III to XI of the Machinery Directive. Some errors noticed by readers have been corrected. Legal references and terms have been updated in line with the Lisbon Treaty - in particular, where the Directive refers to 'the Community', the Guide now refers to 'the EU'.

Following discussion with the industry, the comments relating to chains, ropes and webbing for lifting purposes in §44, §330, § 340, §341, and §357 have been revised in order to clarify the practical application of the requirements relating to these products.

The 2nd Edition also includes a thematic index to facilitate consultation of the Guide. The numbering of the sections of the Guide is unchanged.

The Guide is published on the Commission’s Website EUROPA in English. It is planned to translate the Guide into the other EU languages, but only the English version will be checked by the Commission, therefore, in case of doubt, the English version should be taken as the reference.

The Guide can be downloaded and is presented in a printable format. The text of the Directive is presented in boxed red italic type - the comments follow in black type. It is intended to publish regular updates of the Guide in order to introduce answers to questions agreed by the Machinery Committee and the Machinery Working Group.

The Guide takes account of the amendment to Directive 2006/42/EC introduced by Regulation (EC) N° 569/2009 relating to the regulatory procedure with scrutiny for the Machinery Committee. It also takes account of the provisions of Regulation (EC) N° 765/2008 relating to market surveillance, which apply in a complementary way.

The 2nd Edition of the Guide does not deal with the amendment to the Machinery Directive on machinery for pesticide application introduced by Directive 2009/127/EC that will become applicable on 15th December 2011. This amendment will be covered in the 3rd Edition of the Guide to be published at the end of 2010.

The Guide has been prepared with the help of an Editorial Group.[1] The Commission wishes to warmly thank the members of the Editorial Group both for the huge amount of work they have carried out as well as for the efficient, constructive and cooperative spirit in which the drafts have been prepared. In parallel to the work of the Editorial Group, a Machinery Core Group established by ORGALIME, including representatives of the main sectors of machinery manufacturing, has provided invaluable input from the industry. The drafts prepared by the Editorial Group have been submitted to the Member States and stakeholders for comments. The Commission would also like to thank all those who have made comments. We have tried to take them into account as far as possible.

Of course, the Commission takes full responsibility for the content of the Guide. Readers are invited to communicate any corrections or comments on this 2nd Edition of the Guide[2] so that they can be taken into account in preparing the 3rd Edition.

Brussels, June 2010

The General Editor,

Ian Fraser


Table of contents

The Citations
  § 1 The citations
  § 2 The legal basis of the Machinery Directive
The Recitals
  § 3 The recitals
Recital 1 § 4 The History of the Machinery Directive
Recital 2 § 5 The economic and social importance of the Machinery Directive
Recital 3 § 6 Health and safety
Recital 4 § 7 Definitions
Recital 5 § 8 Inclusion of construction site hoists
Recital 6 § 9 Inclusion of portable cartridge-operated fixing and other impact machinery
Recital 7 §10 Equipment intended for lifting persons with machinery designed 
for lifting goods
Recital 8 §11 Agricultural and forestry tractors
Recitals 9 & 10 §12 Market surveillance
Recital 11 §13 Formal objection to standards and the safeguard clause
Recital 12 §14 Regulations on use of machinery
Recital 13 §15 Measures to deal with groups of hazardous machinery presenting 
the same risks
Recital 14 §16 The state of the art
Recital 15 §17 Machinery for consumer use
Recital 16 §18 Partly completed machinery
Recital 17 §19 Trade fairs and exhibitions
Recital 18 §20 The New Approach
Recital 19 §21 Conformity assessment
Recital 20 §22 Annex IV machinery
Recitals 21 & 22 §23 The CE-marking
Recital 23 §24 Risk assessment
Recital 24 §25 The technical construction file
Recital 25 §26 Legal remedies
Recital 26 §27 Enforcement
Recital 27 §28 Amendment of the Lifts Directive
Recital 28 §29 Subsidiarity and proportionality
Recital 29 §30 National correlation  tables
Recital 30 §31 The Machinery Committee
The Articles
Article 1 (1) §32 The products covered by the Machinery Directive
Article 2 §33 The use of the term 'machinery' in the broad sense
Article 1 (a) §34 Machinery in the strict sense
Articles 1 (a) & 2 (a) §35 The basic definition
1st indent
2nd indent §36 Machinery supplied without connection components
3rd indent §37 Machinery to be installed on a specific support
4th indent §38 Assemblies of machinery
  §39 Assemblies comprising new and existing machinery
5th indent §40 Manually powered machinery for lifting loads
Articles 1 (b) & 2 (b) §41 Interchangeable equipment
Articles 1 (c) & 2 (c) §42 Safety components
Articles 1 (d) & 2 (d) §43 Lifting accessories
Articles 1 (e) & 2 (e) §44 Chains, ropes and webbing
Articles 1 (f) & 2 (f) §45 Removable mechanical transmission devices
Articles 1 (g) & 2 (g) §46 Partly completed machinery
Article 1 (2) §47 Products excluded from the scope of the Machinery Directive
Article 1 (2) (a) §48 Safety components intended to be used as spare parts to 
replace identical components and supplied by the manufacturer 
of the original machinery
Article 1 (2) (b) §49 Equipment for use in fairgrounds and/or amusement parks
Article 1 (2) (c) §50 Machinery for nuclear purposes
Article 1 (2) (d) §51 Weapons, including firearms
Article 1 (2) (e) §52 Means of transport
1st indent §53 Agricultural and forestry tractors
2nd indent §54 Four-or-more-wheeled road vehicles and their trailers
3rd indent §55 Two- and three-wheeled road vehicles
4th indent §56 Motor vehicles intended for competition
5th indent §57 Means of transport by air, on water and on rail networks
Article 1 (2) (f) §58 Seagoing vessels and mobile offshore units and machinery
 installed on board such vessels and/or units
Article 1 (2) (g) §59 Machinery for military or police purposes
Article 1 (2) (h) §60 Machinery for research purposes
Article 1 (2) (i) §61 Mine winding gear
Article 1 (2) (j) §62 Machinery intended to move performers during artistic performances
Article 1 (2) (k) §63 Machinery covered by the Low Voltage Directive
1st indent §64 Household appliances intended for domestic use
2nd indent §65 Audio and video equipment
3rd indent §66 Information technology equipment
4th indent §67 Ordinary office machinery
5th indent §68 Low-voltage switchgear and control gear
6th indent §69 Electric motors
Article 1 (2) (l) §70 High-voltage electrical equipment
Article 2 (h) §71 The definition of ‘placing on the market’
  §72 New and used machinery
  §73 The stage at which the Machinery Directive applies
  §74 The legal and contractual forms of placing on the market
  §75 Auctions
  §76 Placing on the market of assemblies of machinery
  §77 Placing on the market of partly completed machinery
Article 2 (i) §78 The definition of ‘manufacturer’
  §79 Who is the manufacturer ?
  §80 A person manufacturing machinery for his own use
  §81 Other persons who may be considered as manufacturers
  §82 Machinery modified before it is first put into service
  §83 Distributors
Article 2 (j) §84 The possibility to appoint an authorised representative
  §85 The tasks of an authorised representative
Article 2 (k) §86 The definition of ‘putting into service’
Article 2 (l) §87 The definition of ‘harmonised standard’
  §88 (Reserved)
Article 3 §89 The Machinery Directive and other internal market Directives
§90 Specific Directives that apply instead of the Machinery Directive 
to machinery that is in their scope
§91 Specific Directives that may apply to machinery instead of 
the Machinery Directive for specific hazards
§92 Directives that may apply to machinery, in addition to the Machinery Directive, for hazards not covered by the Machinery Directive
Article 4 (1) §93 Market surveillance
  §94 Market surveillance of machinery
Article 4 (2) §95 Market surveillance of partly completed machinery
Article 4 (3) & (4) §96 Market surveillance authorities
  §97 The market surveillance system
  §98 The tools for market surveillance
  §99 Documents relating to Annex IV machinery
  §100 Action to deal with non-compliant machinery
  §101 Unsafe consumer products
  §102 Controls at the external borders of the EU
Article 5 (1) §103 The obligations of machinery manufacturers
Article 5 (2) §104 The obligations of manufacturers of partly completed machinery
Article 5 (3) §105 Means of ensuring the conformity of machinery
Article 5 (4) §106 CE marking according to other Directives
Article 6 (1) & (2) §107 Free movement of machinery and partly completed machinery
Article 6 (3) §108 Trade fairs, exhibitions and demonstrations
Article 7 (1) §109 Presumption of conformity conferred by the CE marking 
and the EC Declaration of Conformity
Article 7 (2) §110 The presumption of conformity conferred by the application 
of harmonised standards
  §111 The classification of machinery standards
  §112 The development of harmonised standards for machinery
  §113 The identification of harmonised standards
Article 7 (3) §114 Publication of the references of harmonised standards in the OJEU
Article 7 (4) §115 Participation of the social partners in standardisation
Article 8 (1) §116 Measures subject to the Regulatory Committee Procedure
Article 8 (2) §117 Measures subject to the Advisory Committee procedure
Article 9 §118 Measures to deal with unsafe machinery presenting similar risks
Article 10 §119 Formal objections to harmonised standards
  §120 The procedure for formal objections
  §121 The outcome of a formal objection
Article 11 (1) §122 The safeguard clause
Article 11 (2) & (3) §123 The safeguard procedure
Article 11 (4) §124 Shortcomings in harmonised standards
Article 11 (5) §125 Action against the person who has affixed the CE marking
Article 11 (6) §126 Information on the safeguard procedure
Article 12 (1) §127 Conformity assessment of machinery
Article 12 (2) §128 Categories of machinery not listed in Annex IV
Article 12 (3) §129 Annex IV machinery designed to harmonised standards that cover 
all the applicable essential health and safety requirements
Article 12 (4) §130 Other Annex IV machinery
Article 13 §131 Procedure for partly completed machinery
  §132 Diagram of the procedures for the placing on the market of machinery and partly completed machinery
Article 14 (1) to (5) §133 Notified Bodies
  §134 Assessment and monitoring of Notified Bodies
Article 14 (6) §135 Withdrawal of certificates or decisions issued by Notified Bodies
Article 14 (7) §136 Exchange of experience between the notifying authorities
  §137 The coordination of Notified Bodies
Article 14 (8) §138 Withdrawal of notification
Article 15 §139 National regulations on the installation and use of machinery
  §140 National regulations on the health and safety of workers
Article 16 §141 The CE marking
Article 17 §142 Non conformity of marking
Article 18 §143 Confidentiality and transparency
Article 19 §144 Machinery ADCO Group
Article 20 §145 Motivation of decisions and appeals
Article 21 §146 Information sources
Article 22 §147 The Machinery Committee
  §148 The Machinery Working Group
  §149 Diagram of institutions dealing with the Machinery Directive
Article 23 §150 Penalties for infringements against the provisions of the Directive
Article 24 §151 The borderline between the Machinery Directive and the Lifts Directive
Article 25 §152 Repeal of Directive 98/37/EC
Article 26 §153 Transposition and application of the provisions of the Directive
Article 27 §154 Transition period for portable cartridge operated fixing and other impact machinery
Article 28 §155 Date of entry into force of the Directive
Article 29 §156 Addressees and signatories of the Directive
     
Annex I : Essential health and safety requirements relating to the design and construction of machinery
General Principles §157 The General Principles
General Principle 1 §158 Risk assessment
  §159 Risk assessment and harmonised standards
General Principle 2 §160 The applicability of the essential health and safety requirements
General Principle 3 §161 The state of the art
  §162 Harmonised standards and the state of the art
General Principle 4 §163 The structure of Annex I
1.1.1 Definitions
1.1.1 (a)  §164 Hazard
1.1.1 (b) §165 Danger zone
1.1.1 (c) §166 Exposed person
1.1.1 (d) §167 Operator
1.1.1 (e) §168 Risk
1.1.1 (f) §169 Guard
1.1.1 (g) §170 Protective devices
1.1.1 (h) §171 Intended use
1.1.1 (i) §172 Reasonably foreseeable misuse
1.1.2 Principles of safety integration
1.1.2 (a) §173 Principles of safety integration
1.1.2 (b) §174 The 3-step method
1.1.2 (c) §175 Preventing abnormal use
1.1.2 (d) §176 Constraints due to the use of PPE
1.1.2 (e) §177 Special equipment and accessories
1.1.3 §178 Materials and products used
1.1.4 §179 Integral lighting
1.1.5 §180  Handling of machinery and parts of machinery
1.1.6 §181 Ergonomic principles
1.1.7 §182 Operating positions in hazardous environments
1.1.8 §183 Seating and the provision of seats
1.2  Control systems  
1.2.1 §184 Safety and reliability of control systems
1.2.2 §185 Control devices
1.2.2 – 1st indent §186 Identification of control devices
1.2.2 – 2nd indent §187 Positioning of control devices
1.2.2 – 3rd indent §188 Movement of control devices
1.2.2 – 4th & 5th indents §189 Location and positioning of control devices
1.2.2 – 6th indent §190 Preventing inadvertent operation of control devices
1.2.2 – 7th indent §191 Strength of control devices
1.2.2 – 2nd para. §192 Control devices to perform different actions
1.2.2 – 3rd para. §193 Control devices and ergonomic principles
1.2.2 – 4th para. §194 Indicators and displays
1.2.2 – 5th & 6th paras. §195 Visibility of danger zones during starting
1.2.2 – 7th para. §196 Location of control positions
1.2.2 – 8th para. §197 Multiple control positions
1.2.2 - last para. §198 Multiple operating positions
1.2.3 §199 Control of starting
1.2.4.1 §200 Normal stop control devices
1.2.4.2 §201 Operational stop
1.2.4.3 §202 Emergency stop devices
1.2.4.4 §203 Stop controls for assemblies of machinery
1.2.5 §204 Mode selection
1.2.6 §205 Failure of the power supply
1.3  Protection against mechanical hazards
1.3.1 §206 Stability
1.3.2 §207 Break-up during operation
1.3.3 §208 Falling or ejected objects
1.3.4 §209 Sharp edges and angles and rough surfaces
1.3.5 §210 Combined machinery
1.3.6 §211 Variations in operating conditions
1.3.7 §212 Moving parts
1.3.8.1 §213 Moving transmission parts
1.3.8.2 §214 Moving parts involved in the process
1.3.9 §215 Uncontrolled movements
1.4  Required characteristics of guards and protective devices
1.4.1 §216 General requirements for guards and protective devices
1.4.2 §217 Special requirements for guards
1.4.2.1 §218 Fixed guards
1.4.2.2 §219 Interlocking movable guards
1.4.2.3 §220 Adjustable guards restricting access
1.4.3 §221 Protective devices
1.5  Risks due to other hazards
1.5.1 §222 Electricity
1.5.2 §223 Unwanted static electricity
1.5.3 §224 Energy supply other than electricity
1.5.4 §225 Errors of fitting
1.5.5 §226 Extreme temperatures
1.5.6 §227 Fire
1.5.7 §228 Explosion
1.5.8 §229 Reduction of noise emission
1.5.8 – 2nd para. §230 Comparative emission data
1.5.9 §231 Vibrations
1.5.10 §232 Ionising and non-ionising radiation
1.5.11 §233 External radiation
1.5.12 §234 Laser radiation
1.5.13 §235 Emissions of hazardous materials and substances
1.5.14 §236 Risk of being trapped
1.5.15 §237 Slips, trips and falls
1.5.16 §238 Lightning
1.6  Maintenance
1.6.1 §239 Maintenance
1.6.2 §240 Access to operating positions and servicing points
1.6.3 §241 Isolation of energy sources
1.6.4 §242 Operator intervention
1.6.5 §243 Cleaning of internal parts
1.7  Information §244 Information for users
1.7.1 §245 Information and warnings on the machinery
  §246 The official languages of the EU
1.7.1.1 §247 Information and information devices
1.7.1.2 §248 Warning devices
1.7.2 §249 Warning of residual risks
1.7.3 – 1st & 2nd paras. §250 Marking of machinery
1.7.3 – 3rd para. §251 Conformity marking for ATEX machinery
1.7.3 – 4th para. §252 Information essential for safe use
1.7.3 - last para. §253 Marking parts of the machinery to be handled with lifting equipment
1.7.4 §254 Instructions
  §255 The form of the instructions
  §256 The language of the instructions
1.7.4.1 (a) & (b) §257 The drafting and translation of instructions
1.7.4.1 (c) §258 Preventing foreseeable misuse
1.7.4.1 (d) §259 Instructions for non-professional users
1.7.4.2 (a) & (b) §260 Contents of the instructions – particulars of the machinery and the manufacturer
1.7.4.2 (c) §261 Inclusion of the EC Declaration of Conformity in the instructions
1.7.4.2 (d) (e) & (f) §262 Descriptions, drawings, diagrams and explanations
1.7.4.2 (g) & (h) §263 Intended use and foreseeable misuse
1.7.4.2 (i) & (j) §264 Assembly, installation and connection
1.7.4.2 (k) §265 Putting into service and use
  §266 Operator training
1.7.4.2 (l) & (m) §267 Information about residual risks
1.7.4.2 (n) §268 The essential characteristics of tools
1.7.4.2 (o) §269 Stability conditions
1.7.4.2 (p) §270 Transport, handling and storage
1.7.4.2 (q) §271 Emergency procedures and methods for unblocking
1.7.4.2 (r) (s) & (t) §272 Adjustment, maintenance and spare parts
1.7.4.2 (u) §273 The noise emission declaration
1.7.4.2 (v) §274 Implantable medical devices
1.7.4.3 §275 Sales literature
2 Supplementary essential health and safety requirements for certain categories of machinery
  §276 Supplementary requirements for certain categories of machinery
2.1.1 §277 Hygiene requirements for machinery intended for use with foodstuffs or with cosmetics or pharmaceutical products
2.2.1 §278 Supplementary requirements for portable hand-held and hand-guided machinery
2.2.1.1 §279 Declaration of vibrations transmitted by portable hand-held and hand-guided machinery
2.2.2 §280 Portable fixing and other impact machinery
2.3 §281 Machinery for working wood and material with similar characteristics
  §282 to §290  (Reserved)
3 Supplementary essential health and safety requirements to offset hazards due to the  mobility of machinery
  §291 Supplementary requirements for hazards due to mobility of machinery
3.1.1 (a) §292 Definition of 'hazards due to mobility'
3.1.1 (b) §293 Definition of 'driver'
3.2.1 §294 Driving position
3.2.2 §295 Seating
3.2.3 §296 Positions for persons other than the driver
3.3 - 1st paragraph §297 Unauthorised use of controls
3.3 - 2nd, 3rd & 4th paras. §298 Remote controls
3.3.1 – 1st para. §299 Location and positioning of the control devices
3.3.1 – 2nd para. §300 Pedals
3.3.1 – 3rd para. §301 Return to neutral
3.3.1 – 4th & 5th para. §302 Steering
3.3.1 - last para. §303 Reverse warning signals
3.3.2 – 1st para. §304 Control of travel movements by a ride-on driver
3.3.2 – 2nd, 3rd & 4th para. §305 Devices exceeding the normal clearance zone
3.3.2 - last para. §306 Unintended travel movement
3.3.3 – 1st, 2nd & 3rd para. §307 Slowing down, stopping and immobilisation
  §308 Regulations for road circulation
3.3.3 – 4th para. §309 Stopping and controlling potentially dangerous operation by remote control
3.3.3 - last para. §310 Stopping of the travelling function
3.3.4 §311 Movement of pedestrian-controlled machinery
3.3.5 §312 Failure in the power supply to steering
3.4.1 §313 Uncontrolled movements
3.4.2 §314 Access to the engine compartment
3.4.3 §315 Roll-over and tip-over
3.4.4 §316 Falling objects
3.4.5 §317 Steps and handholds for access
3.4.6 §318 Towing devices
3.4.7 §319 Removable mechanical transmission devices
3.5.1 §320 Batteries
3.5.2 §321 Fire extinguishers and extinguisher systems
3.5.3 §322 Protection of sprayer operators against risks due to exposure to hazardous substances
3.6.1 §323 Signs, signals and warnings
3.6.2 §324 Marking of mobile machinery
3.6.3.1 §325 Declaration of vibrations transmitted by mobile machinery
3.6.3.2 §326 Instructions on multiple uses
4 Supplementary essential health and safety requirements to offset hazards due to lifting  operations
  §327 The scope of application of Part 4
4.1.1 (a) §328 Lifting operation
4.1.1 (b) §329 Guided load
4.1.1 (c) §330 Working coefficient
4.1.1 (d) §331 Test coefficient
4.1.1 (e) §332 Static test
4.1.1 (f) §333 Dynamic test
4.1.1 (g) §334 Carrier
4.1.2.1 §335 Risks due to lack of stability
4.1.2.2 §336 Rail tracks and guide rails
4.1.2.3 – 1st, 2nd & 3rd para. §337 Mechanical strength
4.1.2.3 – 4th para. §338 Mechanical strength – static test coefficients
4.1.2.3 - last para. §339 Mechanical strength – dynamic test coefficients
4.1.2.4 §340 Pulleys, drums, wheels, ropes and chains
4.1.2.5 §341 Lifting accessories and their components
4.1.2.6 §342 Control of movements
4.1.2.7 §343 Prevention of risks of collisions
4.1.2.8 §344 Machinery serving fixed landings
4.1.2.8.1 §345 Movements of the carrier
4.1.2.8.2 §346 Access to the carrier
4.1.2.8.3 §347 Contact with the moving carrier
4.1.2.8.4 §348 Loads falling off the carrier
4.1.2.8.5 §349 Safety at landings
4.1.3 §350 Checking fitness for purpose
  §351 Static and dynamic tests
  §352 Checking fitness for purpose at the place of use
4.2.1 §353 Control of movements of the machinery and the load
4.2.2 §354 Preventing overloading and overturning
  §355 Loading control on industrial lift trucks
4.2.3 §356 Guide ropes
4.3.1 §357 Information and markings for chains, ropes and webbing
4.3.2 §358 Marking of lifting accessories
4.3.3 §359 Marking of lifting machinery
4.4.1 §360 Instructions for lifting accessories
4.4.2 §361 Instructions for lifting machinery
5 Supplementary essential health and safety requirements for machinery intended for  underground work
  §362 Supplementary requirements for machinery intended for underground work
5.1 & 5.2 §363 Powered roof supports
5.3 §364 Control devices
5.4 §365 Control of travel movements
5.5 §366 The risk of fire on machinery for underground work
5.6 §367 Exhaust emissions
6 Supplementary essential health and safety requirements for machinery presenting  particular hazards due to the lifting of persons
  §368 Scope of Part 6
6.1.1 §369 Mechanical strength
6.1.2 §370 Loading control
6.2 §371 Control devices
6.3.1 §372 Movement of the carrier
6.3.2 – 1st para. §373 Tilt of the carrier
6.3.2 – 2nd & 3rd para. §374 Use of the carrier as a workstation
6.3.2 - last para. §375 Doors on the carrier
6.3.3 §376 Protective roof
6.4 §377 Machinery for lifting persons serving fixed landings
6.4.1 §378 Risks to persons in or on the carrier
6.4.2 §379 Controls at landings
6.4.3 §380 Access to the carrier
6.5 §381 Markings in the carrier
ANNEX II
Declarations
Annex II 1 A §382 The EC Declaration of Conformity of machinery
Annex II 1 A (1) to (10) §383 The content of the EC Declaration of Conformity
Annex II 1 B §384 The Declaration of Incorporation of partly completed machinery
Annex II 1 B (1) to (8) §385 The content of the Declaration of Incorporation
Annex II 2 §386 Custody of the EC Declaration of Conformity and the Declaration of Incorporation
     
ANNEX III
CE marking
Annex III §387 The form of the CE marking
ANNEX IV
Categories of machinery
to which one of the procedures referred to in Article 12 (3) and (4) must be applied
Annex IV §388 Categories of machinery that may be subject to one of the conformity assessment procedures involving a Notified Body
ANNEX V
Indicative list of safety components referred to in Article 2 (c)
Annex V §389 Indicative list of safety components
ANNEX VI
Assembly instructions for partly completed machinery
Annex VI §390 Assembly instructions for partly completed machinery
ANNEX VII
Technical file for machinery - Relevant technical documentation for partly completed machinery
Annex VII A §391 Technical file for machinery
Annex VII A 1 (a) & (b) §392 The content of the technical file
Annex VII A 2 & 3 §393 Communication of the technical file
Annex VII B §394 Relevant technical documentation for partly completed machinery
ANNEX VIII
Assessment of conformity with internal checks on the manufacture of machinery
Annex VIII §395 Assessment of conformity with internal checks on the manufacture of the machinery
ANNEX IX
EC type-examination
Annex IX 1 §396 EC type-examination
Annex IX 2 §397 The application for an EC type examination
Annex IX 3 §398 The content of the EC type-examination
Annex IX 4 to 8 §399 The EC type-examination certificate
Annex IX 9 §400 Validity and review of the EC type-examination certificate
ANNEX X
Full quality assurance
Annex X 1 §401 Full quality assurance
Annex X 2.1 §402 The application for assessment of a full quality assurance system
Annex X 2.2 §403 The objectives and content of the full quality assurance system
Annex X 2.3 §404 Assessment of the full quality assurance system
Annex X 2.4 §405 Implementation and modification of the full quality assurance system
Annex X 3 §406 Surveillance of the full quality assurance system
Annex X 4 §407 Custody of the documentation, decisions and reports relating to the full quality assurance system
ANNEX XI
Minimum criteria to be taken into account by Member States for the notification of bodies
Annex XI §408 Assessment of Notified Bodies

 

 


 

[1] The following people have taken part in the work of the Editorial Group:

Lennart Ahnström, Emilio Borzelli, Robert Chudzik, Roberto Cianotti, Mike Dodds, Cosette Dussaugey, Marcel Dutrieux, Pascal Etienne, Ludwig Finkeldei, Tuiri Kerttula, Thomas Kraus, Partrick Kurtz, Wolfgang Lentsch, Göran Lundmark, Phil Papard, Boguslaw Piasecki, Marc Schulze, Katri Tytykoski, Gustaaf Vandegaer, Henk van Eeden, Richard Wilson, Jürg Zwicky.

[2] Corrections, comments and suggestions for improvement should be addressed to:

ian.fraser@ec.europa.eu

 

English