Minimising the risk of accidents caused by the use of machinery is an essential element of EU policy. The presence of CE marking on a machine is an indication that it meets the harmonised safety requirements in place to allow it to be sold anywhere in the European Economic Area (made up of the 27 EU Member States plus Norway, Iceland and Liechtenstein) as well as in Turkey. This also applies to products manufactured in third countries.
CE marking and the 2006 EU Machinery Directive
The Machinery Directive (2006/42/EC) is intended to harmonise the rules governing the sale of machinery within the EU, while guaranteeing the highest possible level of safety for consumers and workers. It entered into force on 29 December 2009.
The Directive covers machinery, interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing for lifting purposes and removable mechanical transmission devices. It also includes requirements for partly completed machinery. Annex I of the Directive sets out in detail the essential health and safety requirements for the products covered.
An amendment to the Directive was agreed in 2009 introducing new requirements for machinery for pesticide application, which must be designed and manufactured in such a way as to minimise the unintended dispersal of pesticides in the environment. This amendment becomes applicable on 15 December 2011
on the road to CE marking–conformity assessment
For machinery that does not fall under one of the 23 categories listed in Annex IV of the Directive, the manufacturer himself (or his authorised representative in the EU) carries out internal checks on the manufacture of the machinery. If a product falls under one of those 23 categories, the manufacturer has the option of carrying out internal checks on the product only if he has applied in full harmonised European standards covering all of the relevant health and safety requirements.
If this is not the case, then the conformity of the product must be assessed through either the EC-type examination (plus internal checks) or the full quality assurance procedure. These procedures require the involvement of notified Bodies and are explained in Annexes IX and X of the Directive.
Once the conformity assessment is complete, the manufacturer must affix the CE marking to the product – ‘visibly, legibly and indelibly’ in accordance with the specific instructions set out in Annex III of the Directive. The manufacturer must also draw up the EC Declaration of Conformity and ensure that it accompanies the machinery.
finding the relevant European harmonized standards
The first step a manufacturer should take to ensure that a machine will be compliant with the Directive is to check which European harmonized stan dards are applicable. A list of harmonized standards for machinery can be found on the European Commission’s Enterprise and Industry website.
Cooperating with market surveillance authorities
Manufacturers are required to work with the market surveillance authorities in each country in which the machinery is placed on the market. To identify the relevant authority, manufacturers can refer to the contact person in the ministry in charge of implementing the Machinery Directive in each Member State