What is the background to CE Marking?

What does CE Marking apply to?

This applies to all equipment supplied for first time use in the EU

• The manufacturer is accountable

• For equipment imported into the EU, the importer is accountable

• It applies even if the equipment is for self use

• It applies to all machinery supplied after 1 Jan. 1995

What is the intention of CE Marking?

The intention is that any equipment supplied in the EU should meet requirements common to all the member states.  If it does this, then movement between member states is promoted as it is immediately accepted by another country without having to meet additional local requirements.

The driver to this was the Machinery Directive which has been enacted in each member state.  In the UK, the regulation is the Supply of Machinery (Safety) Regulations 2008 and subsequent amendments.

Who polices CE Marking?

The short answer is nobody.  Apart from specific machinery listed in Schedule 4 of the regulations, there is no organisation that either:

• Certifies your machine, or  

• Certifies you as being able to certify your machine.

The process is one of pure trust on the suppliers.  Unfortunately, there is great variation in the knowledge and abilities of different suppliers and a CE label is no indication that the machine is safe.  

Where does the buck stop?

The supplier has obligations under the Supply of Machinery (Safety) Regulations 2008.  The company who puts the equipment into use (ie the employer) has obligations under the Provision and use of Work Equipment Regulations.  It is the employer who has the final accountability for ensuring that the equipment is safe.  

The Process

The key steps to CE Marking

The manufacturer must:

• Design and build the equipment so that it complies with appropriate essential health
  and safety requirements (EHSR’s) and harmonised European standards (HES’s)

• Assess the equipment for conformity with EHSR’s and HES’s

• Be able to compile a technical file proving conformance

• Draw up a declaration of conformity and affix the CE mark to the equipment

Essential Health and Safety Requirements

These are listed in the Supply of Machinery (Safety) Regulations. See a list of these.

Harmonised European Standards

Individual Harmonised European Standards may apply, dependant upon the actual features of the machine. See a list of these.

Technical file

Strictly, the technical file need not be compiled but there must be a system so that you are able to compile it.  In reality, it is generally better to compile one unless you have many similar machines which use common drawings, etc. It contains:

• Overall drawings of equipment and control circuit

• Fully detailed drawings, calculation notes, etc. required to check compliance with EHSR’s and HES’s

• A list of:  
  EHSR’s relevant to the equipment  
  HES’s and other standards used  
  Other technical specifications used in the design  
  Description of methods used to control risks  
  Any technical report or certificates from approved test house

• Copy of instructions for the machinery

Declarations of Conformity and Incorporation

These are the legal certificates that the supplier must provide to the client which declare that the supplier has met his obligations under the Supply of Machinery (Safety) Regulations.  Because they are legal documents, they should be signed by someone in authority.

If the equipment can function independently you must:

• Supply a Declaration of Conformity and

• Fix the CE mark

If the equipment cannot function independently and is supplied for assembly to other equipment which will form later a complete machine then you must:

• Supply a Declaration of Incorporation

• Not fix the CE mark

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