Manufacturers - Frequently asked questions
The UK has left the EU, new rules from January 2021
The transition period after Brexit comes to an end this year.
What safety requirements must my products meet?
EU product supply Directives cover products such as:
- pressure systems
- electrical and personal protective equipment
- equipment for use in potentially explosive atmospheres
If any Directive is relevant to your product, then you (or, in some cases, your authorised representative in Europe) must meet all of the essential health and safety requirements of that Directive.
This must be done before you can place the product on the European market, or before you bring it into use for the first time. The essential health and safety requirements are laid out in each European Directive and copied into the UK regulations that implement each Directive. Failure to adequately meet these legal requirements may be a criminal offence, for which (in many cases) the courts can impose unlimited fines.
What do manufacturers have to do?
Before placing products on the European market, manufacturers (or their authorised representative) must:
- design and construct a safe product
- undertake the relevant conformity assessment procedure for that product (which, in some cases, requires the involvement of a notified body)
- draw up a technical file
- affix the CE mark
- produce a Declaration of Conformity (or a Declaration of Incorporation for partly completed machinery)
- provide user instructions, in the language of the end user
What does the CE mark mean?
By affixing the CE mark, the manufacturer is claiming that the product complies with all EU Directives applicable to that product. However, CE marking in itself does not guarantee safety, nor is it a quality mark. Intermediate suppliers and users of work equipment can rely on the CE mark giving a presumption of conformity with the relevant product supply Directive(s) (and compliance with regulation 10 of PUWER), provided that the product:
How should user instructions be provided?
In all cases they must be in the language of the end user and meet the minimum requirements as specified in the relevant directive. Those parts essential for health and safety should normally be provided with the product in a printed form. Further details on information for new products is available.
Where can I find standards that relate to my product?
English versions of European standards are published by the British Standards Institution and copies can be purchased through the BSI website. Other European language versions may be available through the national standards bodies of other member states.
The titles of all harmonised standards that support one or more product supply Directives are definitively published in the Official Journal (OJ) of the European Union. A list of the these Directives (with details of their OJ references and links to the standards supporting them) is available on the European Commission website.
What legal status do standards have?
In themselves, most standards only provide guidance. It is the essential requirements of the relevant product supply Directive which must be met in law. However, where a manufacturer declares on the Declaration of Conformity compliance with a transposed harmonised standard, the manufacturer must meet its requirements in full. Full compliance with a transposed harmonised standard gives presumption of conformity with one or more essential requirements of the relevant Directive.
What is 'presumption of conformity'?
Manufacturers normally have to show how their particular product complies with all relevant essential requirements of the EU Directive(s) relating to it. This is done through conformity assessment - which can involve a detailed and complex assessment and the collection of significant evidence in a technical file.
However, where a product fully meets the requirements of a transposed harmonised standard written for that product, or an aspect of safety relevant to that product (eg the safety distances to dangerous parts as given in the relevant transposed harmonised standard), the standard may give the manufacturer a 'presumption of conformity' with one or more essential requirements. In other words, the manufacturer then does not need to show in as much detail how the product complies with the Directive(s). This often shortens and simplifies the conformity assessment process and requires less evidence to be produced for the technical file.
To do this, manufacturers must check that a standard can give a presumption of conformity and their product must be within scope of that standard. The basis on which a standard may give presumption of conformity must be verified (this is normally outlined in Annex Z of the standard but, to be sure, checks can also be made with the reference given in the Official Journal of the European Union, or through published listings).
What is covered by the Machinery Directive?
The Machinery Directive which is implemented in the UK by the Supply of Machinery (Safety) Regulations 2008, applies to almost all machinery and partly completed machinery. Certain other products (listed in Article 1 and defined in Article 2 of the Directive) also come within scope of the Directive in the same way as machinery:
- interchangeable equipment
- safety components
- lifting accessories
- chains, ropes and webbing
- removable mechanical transmission devices
However, some machinery-related products are excluded, under Article 1 of the Directive (eg fairground equipment, certain means of transport, certain electrical and electronic products). Other products may be excluded, where covered by another Directive (such as medical devices which are also machines).
Another key exclusion is machinery powered by human or animal effort. However, lifting machines operated by directly applied human effort remain in scope. For more details, see paragraph 32 onwards of the European Commission Guide to the Machinery Directive.
When do I have to use a notified body?
Many products and most machinery do not have to undergo third-party assessment, completed by a notified body. However, the conformity assessment of certain products requires independent assessment by a notified body, prior to the product being CE marked and placed on the market. This includes certain types of higher risk machinery, equipment and safety components, such as:
- cableways and their components
- pressure plant
- gas appliances
- equipment for use in potentially explosive atmospheres
- logic units delivering a safety function
- protective devices designed to detect the presence of persons
The notified body's assessment may take the form of type examination, quality assurance or other means - as specified for that product by the relevant Product Supply Directive.
What is a Certificate of Compliance or Conformance?
This is a document indicating that, in the opinion of a third party (sometimes a notified body), a product is considered to comply or conform with (usually) a product supply Directive. This certificate should be retained in the technical file for the product. However, this is not to be confused with the Declaration of Conformity, which must be issued by the product manufacturer (or their authorised representative). The Certificate of Compliance or Conformance is not a substitute for the Declaration of Conformity.
When is an installer a manufacturer?
Installers constructing machinery in situ from parts not supplied and intended as a complete CE marked product or users making and installing a machine for their own use become the manufacturer for the purposes of the Supply of Machinery (Safety) Regulations, and have the CE marking etc duties to fulfil as the Responsible Person. This is the case for many powered gates, large complex machinery and also for goods/passenger lifts which only exist as a complete product once installed in the environment of use.