Declaration of Conformity

Declaration of Conformity

 

You are no doubt very aware of your commercial document requirements when exporting a consignment overseas, however what about product compliance certificates of Conformity, are you up to speed?

Let’s talk Europe

Most new products come within the scope of one or more EU product safety regulations and Directives. Depending on the Directive that applies to the product, the person responsible for placing on the market must:

  • Identify the Directives and harmonised standards applicable to the product
  • Ensure that the product complies with so-called ‘essential health and safety requirements’
  • Identify which form of conformity assessment (e.g. product testing) is required, especially if a Notified Body must be involved
  • Test the product and check its conformity
  • Draw up and keep available the required technical documentation
  • Affix CE marking to the product and draw up and sign an EC Declaration of Conformity.

It is the manufacturer’s responsibility to draw up and sign the EC Declaration of Conformity, which proves to the authorities that the product meets legal requirements. There are a number of public authorities in each EU Member State nominated to undertake market surveillance and enforce the law. Each Member State has separate ways of enforcing the legislation once it has been implemented into national law. In the UK, for example, this includes Trading Standards services, The Health and Safety Executive, the Medicines and Healthcare products Regulatory Agency and others.

If the enforcement body finds that a product does not meet the above requirements it must be taken off the market. Those responsible may also be liable for a fine or imprisonment.

The EU Declaration of Conformity (DoC) is therefore an essential document, indicating that the product meets all the necessary requirements of the Directives applicable to the specific product.

In most cases the DoC must accompany the product through the supply chain to the end user, who is entitled to receive a copy. A supplier should provide a correct DoC before supplying the product onward.
The DoC must contain

  • 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.

Outside the EU

The EU is a typical template of the checks made by many authorities to ensure safe product is operating within the market place. So what about countries outside of the EU? How do other countries reach assurance that equipment landed meets legal requirements, or specified best practice, often in the form of published standards?

One such example is the Kingdom of Saudi Arabia, where stringent import requirements are operating, in particular the need for a Certificate of Conformity to accompany the equipment into the port of entry. It has often been the case where importers, manufacturers and distributors have either ignored the exacting requirements or not conducted their market research to establish applicable technical regulatory regulations for a specific country such as KSA which has lead unfortunately to the consignment being impounded until such time they or their agent can furnish the authorities with the necessary guarantees of product compliance, usually in the form of a certificate of conformity underpinned with evidence of product testing via an accredited authority.

For further information on Declarations of Conformity, how to obtain one and specific country requirements or other export documents requirement please contact the International Trade team on 01753 870560 or click here to email your enquiry.