Article 2. SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS - annex 1 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.

2. SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR CERTAIN CATEGORIES OF MACHINERY

Foodstuffs machinery, machinery for cosmetics or pharmaceutical products, hand-held and/or hand-guided machinery, portable fixing and other impact machinery, machinery for working wood and material with similar physical characteristics must meet all the essential health and safety requirements described in this chapter (see General Principles, point 4).

2.1. FOODSTUFFS MACHINERY AND MACHINERY FOR COSMETICS OR PHARMACEUTICAL PRODUCTS

2.1.1. General

Machinery intended for use with foodstuffs or with cosmetics or pharmaceutical products must be designed and constructed in such a way as to avoid any risk of infection, sickness or contagion.

The following requirements must be observed:

(a) materials in contact with, or intended to come into contact with, foodstuffs or cosmetics or pharmaceutical products must satisfy the conditions set down in the relevant Directives. The machinery must be designed and constructed in such a way that these materials can be cleaned before each use. Where this is not possible disposable parts must be used;

(b) all surfaces in contact with foodstuffs or cosmetics or pharmaceutical products, other than surfaces of disposable parts, must:

- be smooth and have neither ridges nor crevices which could harbour organic materials. The same applies to their joinings,

- be designed and constructed in such a way as to reduce the projections, edges and recesses of assemblies to a minimum,

- be easily cleaned and disinfected, where necessary after removing easily dismantled parts; the inside surfaces must have curves with a radius sufficient to allow thorough cleaning;

(c) it must be possible for liquids, gases and aerosols deriving from foodstuffs, cosmetics or pharmaceutical products as well as from cleaning, disinfecting and rinsing fluids to be completely discharged from the machinery (if possible, in a "cleaning" position);

(d) machinery must be designed and constructed in such a way as to prevent any substances or living creatures, in particular insects, from entering, or any organic matter from accumulating in, areas that cannot be cleaned;

(e) machinery must be designed and constructed in such a way that no ancillary substances hazardous to health, including the lubricants used, can come into contact with foodstuffs, cosmetics or pharmaceutical products. Where necessary, machinery must be designed and constructed in such a way that continuing compliance with this requirement can be checked.

2.1.2. Instructions

The instructions for foodstuffs machinery and machinery for use with cosmetics or pharmaceutical products must indicate recommended products and methods for cleaning, disinfecting and rinsing, not only for easily accessible areas but also for areas to which access is impossible or inadvisable.

Comment :

The scope of the former Machinery Directive was limited to food machines. It now extends to "MACHINERY FOR COSMETICS OR PHARMACEUTICAL PRODUCTS".

Le champ d’application de l’ancienne directive machines était limité aux machines agro-alimentaires. Il s’étend désormais aux « MACHINES DESTINÉES À L'INDUSTRIE COSMÉTIQUE OU PHARMACEUTIQUE ». 

2.2. PORTABLE HAND-HELD AND/OR HAND-GUIDED MACHINERY

2.2.1. General

Portable hand-held and/or hand-guided machinery must:

- depending on the type of machinery, have a supporting surface of sufficient size and have a sufficient number of handles and supports of an appropriate size, arranged in such a way as to ensure the stability of the machinery under the intended operating conditions,

- except where technically impossible, or where there is an independent control device, in the case of handles which cannot be released in complete safety, be fitted with manual start and stop control devices arranged in such a way that the operator can operate them without releasing the handles,

- present no risks of accidental starting and/or continued operation after the operator has released the handles. Equivalent steps must be taken if this requirement is not technically feasible,

- permit, where necessary, visual observation of the danger zone and of the action of the tool with the material being processed.

The handles of portable machinery must be designed and constructed in such a way as to make starting and stopping straightforward.

2.2.1.1. Instructions

The instructions must give the following information concerning vibrations transmitted by portable hand-held and hand-guided machinery:

- the vibration total value to which the hand-arm system is subjected, if it exceeds 2,5 m/s2. Where this value does not exceed 2,5 m/s2, this must be mentioned,

- the uncertainty of measurement.

These values must be either those actually measured for the machinery in question or those established on the basis of measurements taken for technically comparable machinery which is representative of the machinery to be produced.

If harmonised standards are not applied, the vibration data must be measured using the most appropriate measurement code for the machinery.

The operating conditions during measurement and the methods used for measurement, or the reference of the harmonised standard applied, must be specified.

2.2.2. Portable fixing and other impact machinery

2.2.2.1. General

Portable fixing and other impact machinery must be designed and constructed in such a way that:

- energy is transmitted to the impacted element by the intermediary component that does not leave the device,

- an enabling device prevents impact unless the machinery is positioned correctly with adequate pressure on the base material,

- involuntary triggering is prevented; where necessary, an appropriate sequence of actions on the enabling device and the control device must be required to trigger an impact,

- accidental triggering is prevented during handling or in case of shock,

- loading and unloading operations can be carried out easily and safely.

Where necessary, it must be possible to fit the device with splinter guard(s) and the appropriate guard(s) must be provided by the manufacturer of the machinery.

2.2.2.2. Instructions

The instructions must give the necessary information regarding:

- the accessories and interchangeable equipment that can be used with the machinery,

- the suitable fixing or other impacted elements to be used with the machinery,

- where appropriate, the suitable cartridges to be used.

2.3. MACHINERY FOR WORKING WOOD AND MATERIAL WITH SIMILAR PHYSICAL CHARACTERISTICS

Machinery for working wood and materials with similar physical characteristics must comply with the following requirements:

(a) the machinery must be designed, constructed or equipped in such a way that the piece being machined can be placed and guided in safety; where the piece is hand-held on a work-bench, the latter must be sufficiently stable during the work and must not impede the movement of the piece;

(b) where the machinery is likely to be used in conditions involving the risk of ejection of workpieces or parts of them, it must be designed, constructed, or equipped in such a way as to prevent such ejection, or, if this is not possible, so that the ejection does not engender risks for the operator and/or exposed persons;

(c) the machinery must be equipped with an automatic brake that stops the tool in a sufficiently short time if there is a risk of contact with the tool whilst it runs down;

(d) where the tool is incorporated into a non-fully automated machine, the latter must be designed and constructed in such a way as to eliminate or reduce the risk of accidental injury.

Comment :

Chapter 2.3 has changed little. The examples mentioned in the old Machinery Directive 98/37/EC have been removed.

Original Comment :

Le chapitre 2.3 a peu évolué. Les exemples mentionnés dans l’ancienne directive machines 98/37/CE ont été supprimés.