Harmonised EU Standards

The approach of EU Law

The European Union has harmonised product standards across numerous areas in order to facilitate free movement of goods throughout the EU.   Numerous Directives have been made at EU level which has become law in England and Wales setting out the minimum standards for products and goods over the last 35 years.   The advantage of these common standards is that once goods comply with the standards in one EU state, an exporter can know that they comply automatically with standards throughout the EU.

Under the newer approach, EU Directives seek to harmonise the essential health and safety requirements of goods without prescribing detailed technical requirements in the law itself.  European Standards Bodies prepare and publish technical standards in support of the Directives known as harmonised standards in order to meet the essential health and safety requirements.

The Directive usually states the legal objectives (i.e. the minimum essential health and safety requirements) (HSR) and harmonised standards produced by the Standard Bodies identify the technical means to meet these objectives. Most harmonised standards have evolved through industry groups and are not intended to be restrictive or prescriptive.  Harmonised standards are one method of achieving the HSR but are not mandatory.  Compliance gives a presumption of conformity with the required HSR.

There are harmonised standards across a vast range of products.  They include, for example, motor vehicle, agricultural vehicles, construction, equipment and product.  It covers electrical products, machinery, food stuffs, ceramics, cosmetics, dangerous substances, equipment, pharmaceutical products, petroleum products.

CE Marking

The marking must be applied to the certain products to verify compliance with the essential requirements under the relevant Directives by manufacturers and importers. This is a required before the products in order to market them in the EU or EFTA.

In order to procure CE marking, it is necessary to verify which EU requirements apply to the product.  Conformity assessment procedures could involve self-declaration, testing, inspection or quality system approval. It is necessary to identify whether an independent assessment of conformity is needed from an authorised statutory or another body.  This will depend on the product.

CE marking must not be affixed until all necessary certifications have been obtained from the authorised bodies. The authorised body may be a national standards body or another entity.

A declaration of conformity and the required supporting evidence must be available to the relevant authority in the member state upon request.  Technical documentation required by the Directive must be maintained. Where EU law requires the manufacturer to affix the CE mark before marketing, suppliers must submit to conformity assessment procedures performed by the national standards body.

In order to be entitled to affix the CE mark, the applicant must comply with the conditions relevant to the goods concerned.  Certain fees are payable to the national standards body.  There may be conformity assessment procedure or quality control system.

The certificate holder entitled to provide the CE mark must communicate changes to the standards body. Certain adverse incidents must be notified to the standards body. Records must be maintained.

EU Products Regulation

In 2008, the EU adapted a Regulation, which has direct effect throughout the EU, in order to remove the remaining obstacles to the free circulation of products.  The regulation sets out the requirements for EU wide accreditation and marketing of products.  The Regulation makes it more difficult for States to deny real effect to the EU Treaty rights to provide goods and services throughout the EU, by making it very difficult for member states to justify failure to recognise

The new rules were also designed to improve detection and elimination of unsafe products. They enhance conformity and quality assessment of products and reinforce rules and requirements on notification to conformity assessment bodies.  It increases use of accreditation.  It enhances the “CE” marking.

The Regulation establishes a common legal framework for industrial products. It strengthens the free common market in products which are not yet subject to EU harmonisation such as certain foodstuffs, furniture, bicycles, ladders, precious metals.

Under the Regulation, the objective is to ensure that denial of mutual recognition of each member state’s standards becomes the exception. This is done by putting the onus on member states to objectively justify why it proposes to deny recognition of another member state’s standards.

The onus is on the member state to respond to the foreign business and to justify the failure to recognise the product.  It must do so within a short time frame.  The purpose is to ensure that member states do not use ostensible justification to unfairly deny mutual recognition of products.

If a member state proposes to deny mutual recognition, it must give written notice to the business specifying the technical rule, setting out technical and scientific evidence proving that the proposed decision is justified by an overriding reason of public interest and that no less restrictive measure can be taken.  The decision must be based on the characteristics of the product.

The business may submit comments to the member state within time limits.  The member state must assess the comments before a decision is made.  In giving a decision, it must provide technical and scientific justification for the decision based on the limited grounds in the European Union Treaties.

Contact Point in Each EU States

Each member state must designate at least one Product Contact Centre and inform European Commission and other member states.  This could be a new or existing public body. Various tasks must be performed free of charge by the member state within 15 days.

These tasks include the following;-

• providing the technical information applicable to a specific type of product in that state
• advise whether the marketing and sale product is subject to prior authorisation
• give contact details of the relevant regulatory authorities
• describe the remedies available in the event of a dispute between the authorities.