Machinery Directive

Machinery Directive 2006/42/EC came into force on December 29th 2009, replacing Directive 98/37/EC. It is implemented into UK law by the Supply of Machinery (Safety) Regulations 2008, Statutory Instrument 2008/1597 (see useful links for link to Regulations).

It places a duty on the manufacturer/ importer of equipment which falls under the scope of the Directive, to ensure that the equipment supplied is safe and that the relevant documentation such as Technical Construction File, Declaration of Conformity or Incorporation (as appropriate) is supplied. Where other Directives may apply, such as the Low Voltage and EMC Directives (see Directives list for more information), these must also be taken into account.

In the UK, the lead Government Department is the Department for Business, Innovation and Skills (BIS, see links). BIS has produced guidance notes on the Directive which can be downloaded from their website. The European Union has also produced official guidance for the Directive which is available online.

Definitions

Machinery is defined as:

• (i) 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;
• (ii) an assembly as referred to in sub-paragraph (i), missing only the components to connect it on site or to sources of energy and motion;
• (iii) an assembly as referred to in sub-paragraph (i) or (ii), 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;
• (iv) assemblies of machinery as referred to in sub-paragraphs (i), (ii) and (iii) or partly completed machinery, which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole;
• (v) 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;

Partly completed machinery is defined as:

drive systems and other assemblies which -

• (a) are almost machinery;
• (b) cannot in themselves perform a specific application; and
• (c) are only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment, thereby forming machinery.

Annex 4

Annex 4 of the Directive specifies a list of machine types that are deemed to be more dangerous than others and hence can require the involvement of a Notified Body. Machine types include certain types of woodworking machines, presses for the cold working of metals, plastic and rubber injection moulding machines with manual loading or unloading. The full list is included in both the BIS and Europa guidance documents.

Notified Body

A Notified Body (NB) is a legal entity or person who has been appointed by the Government and notified to the European Commission for the purposes of conformity assessment. In the UK, NBs are assessed by UKAS, the United Kingdom Accreditation Service on an annual basis and the status can be removed at any time.

Routes to compliance

There are 3 routes to compliance for equipment falling under the scope of the Machinery Directive.

• Self Assessment - This route is applicable for all types of equipment not included in Annex 4 of the Directive and for Annex 4 equipment which are wholly covered by harmonised standards. Under this route, the responsible person assesses the equipment against the Essential Health and Safety Requirements of the Directive, produces a technical file, produces a declaration of conformity or incorporation as appropriate and affixes the CE Marking.
• EC Type Examination - This route applies to Annex 4 equipment that is not wholly covered by a harmonised standard or the manufacturer has not chosen to use the self assessment route. To use this route, the responsible person has the equipment assessed by a Notified Body who will issue a Type Examination certificate if they are satisfied that the equipment complies.
• Full quality assurance - This route is for Annex 4 equipment which is manufactured using a full quality control system which has been assessed by a Notified Body. The NB issues the technical documentation and CE Marking.

Additional Machinery Directive Information

• BIS Machinery Directive section
• Europa Machinery Directive section