Declaration of Conformity
Changes due to Brexit
Your health and safety responsibilities will not change when the UK leaves the EU. This guidance is under review.
Most new products must be supplied to end users with a certificate called a Declaration of Conformity which must relate to the particular product placed on the market. This document should declare key information, including:
- the name and address of the organisation taking responsibility for the product
- a description of the product
- list which product safety Directives it complies with
- may include details of relevant standards used
- and be dated, and signed by a representative of the organisation placing it on the EU/EEA market.
What does a Declaration of Conformity mean?
It is a formal declaration by a manufacturer, or the manufacturer's representative, that the product to which it applies meets all relevant requirements of all product safety directives applicable to that product. It is a sign that a product has been designed and constructed for compliance with relevant essential requirements, and has been through the appropriate conformity assessment processes.
A Declaration of Conformity is not a quality certificate, nor a guarantee for safety. However, when properly drawn up along with CE marking on the product, conformity of the product with the Directive(s) quoted on the Declaration of Conformity may be presumed by suppliers in the distribution chain and by the end customer, provided there are no obvious or known defects. Additionally, market surveillance authorities, must presume that CE marked products, accompanied by a Declaration of Conformity comply with the provisions of the Directive(s) mentioned, unless they have evidence to the contrary (for example by examining or testing the product).
Products subject to more than one Directive may come with a single Declaration of Conformity declaring conformity with two or more Directives, or there may be several Declarations, one for each Directive. However, where a CE marked product is incorporated in another, such as a safety interlock in a machine, the Declaration of Conformity for the final product may only declare conformity of the overall final product. In this case the Declaration(s) for any CE marked component parts should form part of the technical file for the complete product.
When must a Declaration of Conformity be provided?
For most new products the Declaration of Conformity must accompany the product through the supply chain to the end user. An exception to this is for electrical equipment within scope of the Low Voltage Directive 2006/95/EC where key information about the product must be supplied, and although a Declaration of Conformity must be drawn up by the manufacturer or the manufacturer's authorised representative, it doesn't have to be supplied to the end user.
What must a Declaration of Conformity state?
The precise requirements are specified in each relevant directive, but essentially Declarations of Conformity should include the following:
- business name and full address of the manufacturer and, where appropriate, his authorised representative;
- for machinery, the name and address of the person authorised to compile the technical file, who must be established in the Community;
- description and identification of the product, which may including information on model, type, and serial number
- a declaration as to which Directive(s) the product fulfils all relevant provisions
- where appropriate, a reference to the harmonised standards used, and to which conformity is declared
- where appropriate, the name, address and identification number of the notified body which carried out conformity assessment
- the identity and signature of the person empowered to draw up the declaration on behalf of the manufacturer or his authorised representative
What should I do with the Declaration of Conformity?
If you are a product supplier you should pass it down the supply chain to the end user as in most cases the final purchaser is entitled to receive a copy of the Declaration of Conformity for the particular product. If you are aware of products (other than those for which a Declaration of Conformity doesn't have to be provided, such as electrical equipment under the Low Voltage Directive) do not have a Declaration of Conformity, you should obtain the correct one before supplying the product onward.
Purchasers should retain Declarations of Conformity as they provide documentary evidence that a product complied with the safety requirements applying to that product when first placed the market, or brought into use, and so have met their duty under Regulation 10 of the Provision and Use of Work Equipment Regulations 1998 (PUWER). This is particularly important for lifting accessories and lifting machinery not requiring assembly or installation on site where the Declaration of Conformity may be a valid substitute for the initial through examination before first use under the Lifting Equipment and Lifting Operations Regulations 1998 (LOLER). Additionally, for lifting equipment subject to LOLER you may need to provide copies of this documentation if you transfer such equipment to another or take a copy of it with you if you use the lifting equipment at another location.
Hirers may also need to copy the Declaration of Conformity onto to users so that users can meet their statutory obligations under LOLER.
What checks can I make if I have concerns about a product's Declaration of Conformity?
Firstly, does the product appear to be unsafe, as sometimes there can be errors and mistakes made with documentation, such as the wrong or no Declaration of Conformity being provided. As a user you can make simple checks on the product itself, looking for any obvious deficiencies, like: no CE marking, missing or incomplete guards, missing or inadequate instructions. A checklist for machinery is provided in the leaflet Buying new machinery.
Concerning the Declaration itself, you can make a number of checks of various aspects, including completeness (by assessment against the requirements of the relevant Directive(s), and of information available in the public domain, such as business names and addresses, including if a Notified Body is listed, and whether it is appointed for the relevant product / Directive. Also, the Declaration of Conformity should relate to the particular product supplied, so should have sufficient detail to identify the product, but need not state specific product serial numbers. However, where serial number are quoted these should match the particular product.
If you find problems in the first instance, such as not being provided with a Declaration of Conformity, you should enquire up through the supply chain, as (in most cases) purchasers are entitled to receive the correct Declaration of Conformity with the product. But if you are not satisfied, particularly if the product appears to have significant safety problems too, you may raise the issue with the relevant market surveillance authority, further information on this is provided in Supplying new machinery.