The completion of the internal market by 31 December 1992 as contemplated under the Single European Act amendments to the treaties required a new method of technical harmonisation of standards. Prior to that, technical standards had been spelled out in detail, which resulted in very slow progress in the harmonisation of standards.
Under the new approach, general rules were established for particular sectors or types of product or risk. This avoided lengthy decision-making process which had involved harmonisation to detailed technical product by product directives.
A Council resolution adopted a new approach on standardisation in the mid-1980s. The following fundamental principles apply.
- States review technical regulations so as to withdraw obsolete and superfluous regulation
- States ensure mutual recognition of test results and establish harmonised rules for certification bodies
- States agree to consultation at an earlier stage where regulatory proposals or procedures might affect the operation.
- The adoption of standards must be submitted to the EU standardisation bodies for approval.
The new approach involves a number of key principles. Legislation on harmonisation is limited to the essential safety requirements or other requirements necessary in the general interest. Products must at least conform to these requirements before enjoying free movement to the EU.
The task of preparing technical specifications is entrusted to organisations which undertake industrial standardisation. Standards are not generally mandatory and are voluntary. Authorities are obliged to recognise products manufactured in accordance with harmonised standards which are presumed to conform with the essential requirements under the directive. If the producer manufactures other than in conformity with those standards, he must prove that the products conform with the essential safety requirements.
Standards must guarantee the quality of the product. Authorities must ensure protection of safety within their jurisdiction.
The Commission issues standardisation mandates to the EU Standardisation Organisation. In the absence of European standards, national standards are verified by a procedure at community level managed by the Commission assisted by a standing committee comprised of individuals from national authorities. There are safeguards to allow authorities the possibility of contesting conformity of a product or quality of a standard.
States are responsible for ensuring the safety of persons and goods in their own territory. The European committee for standardisation (CEN and the European Committee for Electoral Technical Standards) (CEN, ELEC) are the competent bodies to adopt European standards with the scope of directives. In other sectors, other competent bodies may be involved.
Products covered by a directive may only be placed on the market if they do not endanger the safety of persons, animals or goods. The general rule is that only products which conform with the harmonisation requirements of the directive may be placed on the market.
The directive should contain a description of the safety requirements with which all products covered must conform. This should be precise enough so that legally binding obligations can be enforced through national law.
Free movement of products is usually permitted without recourse to prior verification of compliance with essential requirements.
States may presume the conformity of products which are accompanied by one of a number of means of attestation set out in the directive declaring that they conform either with the harmonised standards, or in their absence national standards.
States must communicate to the commission details of the national standards which they consider meet the general requirements for placing on the market and the essential requirements.
The commission ensures that other states are informed of the standards and that they are published in the official journal. National standards are selected on a transitional basis. The decision is to be accompanied by instructions to the competent European organisations to draft a corresponding EU standard.
States accept that a product for which a manufacturer has not applied any standard because of the absence of an existing standard or innovation is considered to be in conformity with the essential requirements when accompanied by an attestation delivered by an independent body.
When states consider the harmonised standards do not satisfy essential requirements, the commission is to bring this to the attention of the committee on standards and technical regulations for its opinion. In light of its opinion, the standard may be withdrawn, revised or maintained.
If a state finds a product might adversely affect the safety of individuals, animals or property, it may take all measures appropriate to withdraw and prohibit the placing on the market of that product. Free movement can be restricted even if products are accompanied by attestation of conformity. In this case, states inform the Commission of the measure, setting out reasons.
The Commission enters into consultation with the states and the standing committee. If the action is justified, the Commission informs states, who are then obliged to prevents the product being placed on the market.
The methods of attestation include
- certificates / marks of conformity issued by third parties.
- testing carried out by third parties.
- declaration of conformity issued by the manufacturer coupled with a surveillance system.
- other means of attestation provided for in the directive.
The national authorities authorise marks / certificates of conformity which are notified by the states to the Commission and other states. They must work in accordance with the International Standards Organisation principles and practice.
National authorities have the right to request the manufacturer to provide them with data relating to safety tests when there is any doubt about conformity with safety requirements. Manufacturers may prove in any manner they see fit within the framework of a dispute or court proceedings the conformity of the product.
Directives distinguish between the essential requirements which are to be harmonised and other manufacturing specifications.
An EU communication in 2003 sought to give fresh impetus to the technical harmonisation system. The communication calls for greater transparency in the operation of the national standards bodies.
It calls for national legislative requirements to be implemented to ensure consistence in accreditation and accreditation services. States must ensure that standards bodies continue to have the technical qualifications required by the directive.
Approved standard bodies may pursue activities in the internal market under the principles of mutual recognition. The commission supports information exchange procedures between agencies and accreditation bodies in the host state and the designating authority in the home authority for the relevant body.
The system of conformity approval may be used in both areas subject to formal regulation and those not so subject. The standard body should adopt the same principles. The Commission introduced provisions to provide for exchange of information on products which are found non-compliant.
Although market surveillance is a matter for the national authority, the commission has endeavoured to achieve a common level of market surveillance based on common criteria, including
- adequate infrastructure and human resources,
- strategic surveillance program based on risk analysis,
- dissuasive penalties proportionate to the degree of noncompliance,
- effective communication and coordination between authorities and other entities,
- full participation by national authorities and administrative cooperation with their counterparts.
Market surveillance must be accompanied by effective cross-border administrative cooperation including reinforced mutual assistance between the national authorities in undertaking market surveillance, cleaner operational framework for administrative cooperation, faster exchange of information on noncompliant products, public access to information on dangerous products.
States are obliged to take measures against products which are unsafe. The absence of CE marking on a product which should carry it allows the national authority to deem the product noncompliant. Safeguard clause procedure in the directives allows the commission to verify the grounds for national measures which aim to restrict free movement of goods.
The Commission has taken steps to amend the safeguard procedure by revising the legal framework to guarantee a more uniform approach under the directives.
The general product safety directive is relevant to goods and products covered under the new approach directive.
Accreditation and market surveillance
The purpose of this Regulation is to provide a common framework for the accreditation infrastructures within the European Union (EU) and, as a consequence, to facilitate movement of goods between the Member States. Correct operation of the accreditation infrastructures is essential in guaranteeing control of product conformity assessment bodies and surveillance of the products and economic operators on the European market.
Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (Text with EEA relevance).
This Regulation envisages the laying down of clear rules on the organisation and operation of accreditation, in the Member States, of conformity assessment bodies performing assessment of any substance, preparation or other product, transformed or not, to be placed on the Community market.
It is important to guarantee a high level of market surveillance in order to satisfy the requirements of protection of public interests such as health and safety in general, health and safety in the workplace, protection of consumers, the environment and security.
These rules reinforce the existing system, without weakening existing instruments such as the General Product Safety Directive, which has on the whole been successful.
This Regulation provides a framework for European accreditation policy. For the first time it establishes a common legal basis for accreditation, therefore providing a comprehensive legal framework for regulating the organisation of accreditation within the European Economic Area (EEA) from 1 January 2010.
Whether voluntary or compulsory, accreditation is recognised as the last level of control of the suitability of conformity assessment services. Accreditation has no commercial purpose, since this would reduce its value and credibility.
Accreditation is characterised by the following:
- there is only one accreditation body per Member State
- there is no competition between accreditation bodies and conformity assessment bodies;
- accreditation is carried out by a public authority;
- accreditation bodies operate on a not-for-profit basis and comply with the principles of impartiality and objectivity.
The European cooperation for Accreditation (EA) shall be responsible for managing the peer assessment which monitors the responsibilities and functioning of the national accreditation bodies. Through this peer evaluation system, the EA contributes to the quality of the services provided by national accreditation bodies and therefore to the mutual acceptance of conformity certificates throughout the EU and the rest of the world.
Member States guarantee effective surveillance of their market. They are required to organise and carry out close monitoring so that the products covered by Community harmonisation legislation meet the requirements for protection of public interests such as health or safety.
The competent market surveillance authorities in each Member State monitor products on the Community market. They are responsible for:
- monitoring compliance with product safety requirements;
- following up complaints or reports on product-related risks;
- monitoring accidents and damage to health suspected to have been caused by these products;
- verifying corrective action has been taken;
- following up and updating scientific and technical knowledge concerning safety issues;
- following up on the notification of dangerous products on RAPEX.
The Member States must cooperate with each other and ensure that information is exchanged between them and the Commission and the relevant Community agencies.
Market surveillance authorities must perform appropriate checks on the characteristics of products – through documentary, physical and laboratory checks – and may require economic operators to make available the necessary information and enter their premises to better perform, totally independently, their surveillance task.
If the authorities identify a product as presenting a risk, they shall alert users by taking the appropriate measures. If it presents a serious risk Member States ensure that:
- the product details are changed on RAPEX;
- the product is recalled or withdrawn;
- the product is modified and the risk removed.
In cases of risk, Member States must inform the economic operator in question and the Commission of their decision without delay, stating precisely the reasons for this.
Where controls on products entering the Community market are concerned, the Member States provide their customs authorities with all the means necessary to ensure that the appropriate checks are carried out on the product’s safety before it is released for free circulation. In the event of serious danger, assumed or actual, or in the absence of the necessary accompanying documents, the customs authorities must suspend release for free circulation of the product in question.
The market surveillance authorities and the customs authorities cooperate to ensure effective control of product safety.
Certain activities planned for the application of this Regulation may be financed by the Union.
This Regulation repeals Regulation (EC) No 339/93 as of 1 January 2010.
|Act||Entry into force||Deadline for transposition in the Member States||Official Journal|
|Regulation (EC) No 765/2008||2.9.2008||–||OJ L 218 of 13.8.2008|
Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC (Text with EEA relevance) [OJ L 218 of 13.8.2008].
Last updated: 17.11.2010
- For more details, visit the DG Enterprise and Industry website on mutual recognition