General principles of annex 1 of machinery directive 2006/42/EC

The text in RED color is the amended or added text in comparison with the former 98/37/EC machinery directive


GENERAL PRINCIPLES

1. The manufacturer of machinery or his authorised representative must ensure that a risk assessment is carried out in order to determine the health and safety requirements which apply to the machinery. The machinery must then be designed and constructed taking into account the results of the risk assessment.

Comment: risk assesment

The four principles of safety must be applied in the order as defined. This is the assessment process and risk reduction defined in EN 12100-1.

The ESSENTIAL HEALTH AND SAFETY REQUIREMENTS (EHSR) of Annex 1 of the Directive are based four general principles:

  • The first principle relates to the risk assessment (formerly risk analysis in the previous directive) as a basic principle to identify hazards and assess risks associated with the machine so as to apply the EHSR that relates to the machine
  • Other general principles (numbered 2, 3 and 4, below) are essential and must be taken into account to satisfy the EHSR in the design and construction of the machine.

The EHSR are only applicable when there is a hazard for the machine. The list of dangers is the subject of all the chapters of Annex I of the Directive. During hazard identification, the machine builder must take into account ALL phases of machine life (transport, implementation, operation, maintenance, ...).

This risk assessment process is an iterative process in which each risk reduction measure must be evaluated in order to measure its contribution to the overall risk reduction. An other objective is to ensure that this measure does not generate any new risk.

At the risk analysis level, that must be performed by the manufacturer or its agent or an other entity acting on its behalf. In all cases, the manufacturer remains responsible for the completeness and extent of the risk analysis and the implementation of the necessary measures to reduce risks during the phases of design and building of the machine. The results of this risk analysis are components of the construction file ("technical file")

Original Comment : Evaluation des risques

Les quatre principes de sécurité doivent s’appliquer dans l’ordre. Il s’agit du processus d’évaluation et de réduction des risques mentionné dans la norme EN 12100-1.

Les exigences essentielles de sécurité et de santé (EESS) de l’annexe 1 de la directive ont pour base 4 principes généraux :

  • Le premier principe concerne à l’évaluation des risques (anciennement analyse de risque dans la précédente directive) comme principe de base pour identifier les dangers et évaluer les risques en rapport avec la machine de façon a appliquer les EESS qui se rapportent à la machine
  • Les autres principes généraux (numérotés 2, 3 et 4 –ci-après) sont essentiels et doivent être pris en compte de façon à satisfaire les EESS lors de la conception et de la construction de la machine.

Les EESS sont applicables uniquement lorsque le danger existe pour la machine en question. La liste des dangers fait l’objet de tous les chapitres de l’annexe I de la directive. Lors de l’identification des dangers, il faut tenir compte de TOUTES les phases de vie de la machine (transport, mise en œuvre, utilisation, maintenance, …).

Ce processus d’évaluation des risques est un processus itératif, dans lequel chaque mesure de réduction du risque doit être évaluée dans le but de mesurer sa contribution à la réduction du risque global. Elle a également pour but de s’assurer que cette mesure ne génère pas de nouveau risque.

Au niveau de l’analyse de risques, cette dernière doit être réalisée par le fabricant ou de son mandataire ou par une autre entité agissant en son nom. Dans tous les cas, le fabricant reste responsable de la complétude et de l’étendue de cette analyse de risques et de la mise en place des mesures nécessaires de réduction de risques lors des phases de conception et de construction de la machine. Les résultats de cette analyse de risque sont des éléments constitutifs du dossier de construction (« technical file »)

Comment 3: Risk assessment and C-type standards

The risk analysis is to be done, however, if a type C standard exists, then the requirements of this C-standard covers partially or completely all risks of the machine. In this case, the risk analysis can be simplified.

Original Comment  3: Evaluation des risques et normes de type C

L’analyse de risque est à faire, toutefois dans le cas ou une une norme de type C existe, alors les exigences de cette norme couvrent partiellement ou totalement l’ensemble des risques de la machine. Dans ce cas, cette analyse de risque peut être simplifiée.

By the iterative process of risk assessment and risk reduction referred to above, the manufacturer or his authorised representative shall:

- determine the limits of the machinery, which include the intended use and any reasonably foreseeable misuse thereof,

- identify the hazards that can be generated by the machinery and the associated hazardous situations,

- estimate the risks, taking into account the severity of the possible injury or damage to health and the probability of its occurrence,

- evaluate the risks, with a view to determining whether risk reduction is required, in accordance with the objective of this Directive,

- eliminate the hazards or reduce the risks associated with these hazards by application of protective measures, in the order of priority established in section 1.1.2(b).

2. The obligations laid down by the essential health and safety requirements only apply when the corresponding hazard exists for the machinery in question when it is used under the conditions foreseen by the manufacturer  or his authorised representative or in foreseeable abnormal situations. In any event, the principles of safety integration referred to in section 1.1.2 and the obligations concerning marking of machinery and instructions referred to in sections 1.7.3 and 1.7.4 apply.

Comment:

foreseeable abnormal situations must also be considered.

Original Comment:

Les situations anormales prévisibles doivent également être considérées.

3. The essential health and safety requirements laid down in this Annex are mandatory; However, taking into account the state of the art, it may not be possible to meet the objectives set by them. In that event, the machinery must, as far as possible, be designed and constructed with the purpose of approaching these objectives.

4. This Annex is organised in several parts. The first one has a general scope and is applicable to all kinds of machinery. The other parts refer to certain kinds of more specific hazards. Nevertheless, it is essential to examine the whole of this Annex in order to be sure of meeting all the relevant essential requirements. When machinery is being designed, the requirements of the general part and the requirements of one or more of the other parts shall be taken into account, depending on the results of the risk assessment carried out in accordance with point 1 of these General Principles.

Comment:

This last safety principle insists once again on the need to perform a risk assessment, and then to comply with the essential health & safety requirements that apply to all machines and are defined in the general part of annex (Chapter 1) and to meet the specific requirements set out in Annex 1 (Chapters 2 to 6) for other specific machines.

Original Comment:

Ce dernier principe de sécurité insiste une fois encore sur la nécessite de réaliser une évaluation des risques, puis de satisfaire les exigences essentielles de sécurité et de santé générales qui s’appliquent à toutes les machines et définies dans la partie générale de l’annexe 1 (chapitre 1) puis de satisfaire les exigences particulières définies à l’annexe 1 (chapitres 2 à 6) pour les autres machines spécifiques.