Supply of Machinery (Safety) Regulations 2008 (SI 2008 No. 1597)

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Garry Kenneth Atkins
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1 Supply of Machinery (Safety) Regulations 2008 (SI 2008 No. 1597) The Regulations The legislation transposes the machinery directive (2006/42/EC). It consists of 28 Regulations (in 7 Parts) and 7 schedules. Schedule 2 reproduces verbatim 11 annexes from the machinery directive. Like many directives of this kind, the machinery directive aims to remove barriers to trade by harmonising safety requirements. The following extracts concentrate on certain key areas. Regulations 2, 4-6 As always, definitions and disapplications are crucial to an understanding of any new legislation and these are contained throughout but especially in Regulations 2 and 4-6. Some of the more important definitions are listed below: CE marking means a mark consisting of the symbol "CE" set out in the form shown in Annex III (Part 3 of Schedule 2). Essential health and safety requirements means the requirements in Annex 1 (Part 1 of Schedule 2), sections 1 to 6, read in the light of the general principles set out at the start of the Annex. harmonised standard means a non-binding technical specification adopted by the European Committee for Standardisation (CEN) or the European Committee for Electro technical Standardisation (CENELEC) or the European Telecommunications Standards Institute (ETSI) on the basis of a remit issued by the European Commission. Machinery this is extensively defined in Regulation 4 and includes assemblies fitted with drive systems (like circular saws), interchangeable equipment (such as is used with a tractor), safety components, lifting accessories (like slings), Some machinery (listed in Schedule 3) is specifically excluded. Also excluded is machinery wholly covered by more specific requirements of other Directives (see reg 5). Partly Completed Machinery this is essentially machinery which cannot perform a specific application and which is only intended to be incorporated into other machinery. responsible person means, in relation to machinery or partly completed machinery: the manufacturer the manufacturer's authorised representative safe means, in relation to machinery, that, when the machinery is properly installed and maintained and used for the purposes for which it is intended, or under conditions which can reasonably be foreseen, it does not (a) Endanger the health of, or result in death or injury to, any person; or (b) Where appropriate (i) Endanger the health of, or result in death or injury to, domestic animals; or RRC Training

2 (ii) Endanger property Regulation 7: Supply of machinery: general obligations and prohibitions (1) No responsible person shall place machinery on the market or put it into service unless it is safe. (2) Before placing machinery on the market or putting it into service, the responsible person must: i) ensure that the machine satisfies the relevant essential health and safety requirements ii) ensure that the technical file is compiled and made available iii) Provide information necessary to operate the machine safely iv) Follow the appropriate conformity assessment procedure (outlined in regs 10, 11 and 12) v) draw up the EC declaration of conformity (a copy must accompany the machinery and the original retained), prescribed in Annex II vi) Affix the CE marking to the machinery (visible, legible, and indelible), prescribed in Annex III (3) The responsible person must carry out all necessary research and testing to comply with (1) and (2). (4) There is a presumption of conformity with the Essential Health and Safety Requirements if a machine is manufactured in accordance with a published harmonised standard ( published here meaning a standard whose reference has been published in the Official Journal of the European Communities). This of course is only to the extent to which that standard covers the essential health and safety requirements. (5) and (6) For certain procedures covered by regs 11 and 12 there may be on-going obligations, as prescribed in Annexes IX and X (these are related to EC Type-examination and full quality assurance options, respectively). Regulation 8: Supply of partly completed machinery: general obligations and prohibitions (1) Before partly completed machinery is placed on the market, the responsible person must: (i) Prepare and make available the relevant technical documentation (described in Annex VII) (ii) Prepare assembly instructions (Annex VI) (iii) Draw up a declaration of incorporation The assembly instructions and declaration of incorporation are supplied with the partly completed machinery. Once incorporated into a machine, the assembly instructions and declaration of incorporation form part of that machine s technical file (discussed later). Once again all necessary research and tests must be conducted. 354 RRC Training

3 Regulation 9: Putting into service This prohibits a person who is not a responsible person (i.e. not a manufacturer) from putting machinery into service unless it complies with the applicable essential health and safety requirements. Regulation 10: Machinery not referred to in Annex IV Annex IV refers to categories of machinery which are considered more dangerous (e.g. circular saws, chain saws). This regulation applies to those which do not appear in that list (i.e. most other general machinery). For these cases, the conformity assessment procedure prescribed in Annex VIII (i.e. reproduced in Schedule 2, Part 8) should be followed. This involves the responsible person drawing up a technical file and ensuring that the manufacturing process is checked to make sure it produces products that comply. This procedure is commonly called self-assessment Regulation 11: Annex IV Machinery manufactured fully in accordance with Published Harmonised Standards and Fully Covered by those Standards If the machinery is identified in Annex IV and it is manufactured wholly in accordance with one or more published harmonised standards and those standards fully cover that machine then the responsible person has a choice of three conformity assessment procedures. These are prescribed in Annexes VIII, IX and X, respectively. The Annex VIII ( self-assessment ) procedure has already been outlined. The Annex IX ( EC Type-Examination ) procedure involves submission of a representative sample of the machine and also the technical file to a notified body. The notified body carries out the conformity assessment and issue an EC Type-Examination Certificate if it complies. The Annex X ( Full Quality Assurance ) procedure requires the responsible person to produce the machine under an approved quality management system (which must cover design, manufacture, inspection and testing). A notified body assesses and approves the quality management system. The technical file is also assessed as part of this. Regulation 12: Annex IV Machinery not manufactured fully in accordance with Published Harmonised Standards or not Fully Covered by those Standards A reduced choice is available to Annex IV machinery not fully covered by published harmonised standards. This might be because no published harmonised standards exist for the machine in question. In these cases, the responsible person can follow either Annex IX or X procedures (i.e. EC Type-examination or full quality assurance). Regulation 13: CE-marked machinery taken to comply with the regulations Unless there is evidence to the contrary, enforcement authorities, courts and the secretary of state are obliged to presume that a CE -marked machine accompanied by a valid EC declaration of conformity complies in all respects with these regulations. Failure to provide a copy of the technical file when requested by an enforcement authority provides reasonable grounds for suspicion. Regulation 14: Machinery covered by more than one directive Where more than one directive applies to a machine, the application of the CE -mark signifies that all applicable requirements or all relevant directives are satisfied (there may be exceptions to this if allowed by the other directive RRC Training

4 Regulation 15: Protection of CE-marking CE-marks must not be applied to machinery which does not comply with these regulations. Neither must anyone affix a marking that is likely to be confused with a CE mark or impair the CEmark or mislead people as to the meaning of the CE mark. Regulations 16-19: Notified Bodies These regulations cover the designation, monitoring, term, functions and fee levying of notified bodies. These are third parties designated by the secretary of state to carry out certain functions (like EC Type-examination and assessment and approval of Quality Systems under the conformity procedures mentioned earlier). The notified refers to the fact that they are notified by the secretary of state to the European Commission. Regulations 20-24: Enforcement The powers of the enforcement authorities are detailed in Schedule 5. There are the usual offences and penalities. A statutory defence of due diligence is also available for the accused. Selected Schedules: Schedule 2, Part 2 (Annex II of the Directive): EC Declaration of Conformity and Declaration of Incorporation We shall only describe the EC declaration of conformity here, which should: state the business name and full address of the responsible person and, where that person is not the manufacturer, of the manufacturer state the name and address of the person authorised to compile the technical file contain a description and identification of the machinery including, in particular its make; generic denomination, function, model, type; commercial name and serial number contain a sentence expressly declaring that the machinery fulfils all the relevant requirements of the Directive (and similar sentences for all other Directives that apply) State, where appropriate the name, address and identification number of the notified body which carried out the EC type-examination and the number of the EC type-examination certificate (as per Annex IX procedure). State, where appropriate the name, address and identification number of the notified body which approved the full quality assurance system (as per Annex X procedure). specify (as appropriate) the published harmonised standards used specify (as appropriate) other technical standards and specifications used specify place and date of the declaration disclose the identity and contain the signature of the person empowered to draw up the declaration on behalf of the responsible person. 356 RRC Training

5 Schedule 2, Part 3 (Annex III of the Directive): CE Marking This part of the schedule gives the specification of the CE mark itself. RRC Health & Safety Law & Case Law Guide Where an Annex X conformity procedure has been followed (i.e. full quality assurance), the mark is followed by the identification number of notified body. Note that the CE marking is not the only marking that may be required. Annex I (Schedule 2, Part 1) identifies a number of items that may also need to be included as part of compliance with the essential health and safety requirements (1.7.3), namely: Name and address of the manufacturer; Designation of machinery; Designation of series or type; Serial number, if any; Year of construction (i.e. when it was actually completed); If designed for such, information regarding its use in an explosive atmosphere; Any safety-related information regarding the machinery in use (e.g. maximum speed of rotating parts); Mass of any part where it must be handled by lifting equipment during use. Schedule 2, Part 7 (Annex VII of the Directive): Technical Files We will only describe the technical file for machinery here (that for partly completed machinery is similar). The technical file for machinery consists of: A general description of the machine Drawings of the machine. Drawings of the control circuitry. Details of tests carried out to check conformity against essential health and safety requirements. List of applicable essential health and safety requirements Description of methods adopted to eliminate hazards. The standards and other technical specifications used (indicate the essential health and safety requirements covered by these standards) Any technical reports/certificate giving the results of tests. A copy of the instructions for the machinery. Where appropriate, the declaration of incorporation for included partly completed machinery Where appropriate, the EC declaration of conformity of machinery/products incorporated into the machine A copy of the EC declaration of conformity For series manufacture, the internal measures to be taken to ensure that production machinery is to the same standard (i.e. quality assurance and quality control). The technical file for partly completed machinery is similar but slightly different in the details. RRC Training

(recast) (Text with EEA relevance)

(recast) (Text with EEA relevance) 29.3.2014 Official Journal of the European Union L 96/45 DIRECTIVE 2014/29/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 26 February 2014 on the harmonisation of the laws of the Member States relating