The Supply of Machinery (Safety) Regulations 2008 Mike Lewis CMIOSH November 2009

Regulations The new Regulations enact the Machinery Directive 2006/42/EC and replace the Supply of Machinery (Safety) Regulations 1992 and subsequent Amendments. The Regulations come into force on 29th December 2009. The Regulations can be viewed or downloaded at www.opsi.gov.uk/si/si2008/uksi_20081597_en_1

Key Changes The same basic principles apply but some underlying detail has changed. The Regulations provide clearer definitions. Builders goods hoists and cartridge operated tools are included in the scope. Safety components, such as chains, ropes and webbing, are required to be CE marked. Some provisions apply to ‘partly completed machinery’.

Key Changes (cont’d) Provides manufacturers with the option to use full quality assurance in the conformity assessment process for products regarded as particularly hazardous e.g. circular saws power presses plastic injection moulding machines etc. A full list is contained in (Annex IV of the Regulations). Provides an updated list of essential health and safety requirements. Minor changes to the contents of the Declaration of Conformity.

The Regulations apply to: Machinery described as: 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 as defined above, missing only the components to connect it on site or to sources of energy and motion; an assembly as defined above, 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 structure; assemblies of machinery as referred to above, or partly completed machinery, which, in order to achieve the same 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.

The Regulations apply to: Interchangeable Equipment described as: devices which, after the putting into service of machinery or of a tractor, are assembled with that machinery or tractor by operators themselves in order to change its function or attribute a new function, in so far as they are not tools.

The Regulations apply to: Safety Components described as components: which serve to fulfil a safety function; which are independently placed on the market; the failure or malfunction of which endangers the safety of persons; and which are not necessary in order for the machinery to function, or for which other components which do not fall within previous sub paragraphs may be substituted in order for the machinery to function. Full list of examples is provided in Annex V of the Regulations.

The Regulations apply to: Lifting Accessories Chains, Ropes and Webbing. Removable Mechanical Transmission Devices. Drive Systems. Partly Completed Machinery.

Exceptions The new Regulations do not apply to machinery and safety components: Listed in Schedule 3 of the Regulations. In transit through the EU e.g. auctioned for use outside the EU. Previously put on the market or in service prior to 29th December i.e. second-hand machinery. That are in the supply chain prior to 29th December 2009, but unused. Exhibited at a trade fair or exhibition.

General Requirements It is an offence for a ‘Responsible Person’ to supply machinery, partly completed machinery or safety components unless they comply with the Regulations i.e. they have the requisite Technical File, Declaration of Conformity, EC type Examination Certificate, Declaration of Incorporation, as appropriate; the product is CE marked; and the product is safe!

Conformity Assessment The responsibility for demonstrating that machinery complies with the Directive rests with the ‘Responsible Person’. There are three methods of conformity assessment. Self Assessment EC Type Examination Full Quality Assurance

Self Assessment This method is used for any machinery not included in Annex IV of the Regulations. The ‘Responsible Person’ required to: Undertake a risk assessment against the Essential Health and Safety Requirements (see Schedule 2 Annex I of the Regulations); Produce a Technical File; Produce a Declaration of Conformity; Affix CE mark to the product.

EC Type Examination This method is used where the machinery is included in Annex IV of the Regulations, but is not manufactured wholly in accordance with harmonised standards. The machinery is required to be assessed by a ‘Notified Body’. If compliant, the ‘Notified Body’ will issue an EC-type examination certificate.

Full Quality Assurance This method is used for machinery included in Annex IV of the Regulations and manufactured using a full quality assurance system. The ‘Responsible Person’ having manufactured a product using a full quality control system, is required to have their system assessed by a ‘Notified Body’, which has been accredited by UKAS. The ‘Notified Body’ will arrange the issue of any necessary documentation and CE marking.

Further Guidance The European Commission is scheduled to publish comprehensive guidance on the entire text of the revised Machinery Directive in early December 2009. The guidance will be web-based only.

Further Guidance BIS, the Department for Business, Innovation and Skills (previously known as BERR and the DTI), has published guidance notes on the Regulations. The BIS guidance summarises and puts into 'plain English' the contents of the Machinery Directive. The guidance notes on the UK Regulations can be viewed or downloaded at http://www.berr.gov.uk/files/file52968.pdf