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Enhancing the implementation of the New Approach Directives
In order to give fresh impetus to the technical harmonisation system, the Commission has recommended better ways to implement the New Approach Directives with the objective of reinforcing the free movement of goods in the context of an enlarged European Union (EU). These recommendations aim to promote safer, cheaper and more competitive European products.
Communication from the Commission of 7 May 2003 to the Council and the European Parliament "Enhancing the implementation of the New Approach Directives" [COM(2003) 240 final - Not published in the Official Journal]
Making the free movement of goods work better in an enlarged European Union is one of the key elements of the Commission's Internal Market strategy for the 2003-2006 period. The directives based on the " New Approach " cover a significant proportion of the industrial products placed on the European market.
The New Approach has proved an effective instrument for ensuring the free movement of goods within the internal market. The implementation of its directives can, nevertheless, be further improved. Applying the New Approach Directives in a more consistent way helps to encourage third countries to adopt regulatory approaches based on the EU regulatory framework.
This communication contains proposals aimed at improving the functioning of the internal market and is part of the process of improving the regulation and competitiveness of European industry. In this way, the internal market instruments may achieve uniform implementation and a good level of compliance with Community legislation.
New Approach directives provide for both pre-market and post-market product controls to ensure a high level of product safety. The proposals listed in this communication relate mainly to:
- notified bodies;
- conformity assessment procedures;
- enforcement and market surveillance;
- consistent and efficient implementation of the New Approach Directives.
The conformity assessment procedures of the New Approach Directives are based on the conformity assessment modules. Most of these modules require the intervention of an external notified body, which assesses the risk products in question.
The Commission calls on the Member States to ensure that authorities responsible for notification are fully aware of their obligations concerning the notification procedure. Efforts must be made to reduce the period elapsing between the decision to notify a body and completion of the notification procedure.
The lists of notified bodies for each directive are published in the Official Journal of the European Union. The Commission proposes to replace the publications with an on-line notification system, which will enable the notified bodies to act almost immediately.
The individual directives form the legal basis for the notification of bodies. They do not, however, include any detailed provisions on the application of criteria for designating notified bodies; this is in the powers of the Member States. It is nevertheless necessary for the implementation of notification to be more transparent and better applied. The Commission considers it necessary to consolidate the legislative requirements to be met by notified bodies, and this could be covered either as part of a horizontal directive or in the form of a standard article to be included in the various directives.
The role of accreditation
The Commission proposes to draft fuller guidelines on the use of accreditation in order to increase consistency and to reinforce the structure of accreditation services within the Community. A permanent forum of Member States' authorities responsible for designation is proposed in order to facilitate the exchange of best practices for the assessment, designation and surveillance of notified bodies.
Surveillance of notified bodies
National accreditation organisations frequently monitor and evaluate the bodies they have notified, so that Member States can ensure that notified bodies continue to have the technical qualifications required by the directives.
The Commission proposes to incorporate into the New Approach Directives an exchange of experiences between notified bodies and also provisions on measures to take when notified bodies do not carry out their duties correctly or cease to provide their services.
A notified body can automatically pursue its activities anywhere in the internal market by means of the principle of mutual recognition. However, the national authorities responsible for designation do not always have the tools required to evaluate and monitor the activities of bodies that operate in countries outside their jurisdiction.
The Commission plans to support the establishment of an information exchange procedure between authorities and/or accreditation bodies in the host country and the designating authority in the home country of notified bodies. This would require a legal basis to be introduced either in a common base or in individual New Approach Directives. In addition, the Commission emphasises the need for a structured framework to allow conformity assessment bodies from other countries to perform tasks in compliance with the New Approach Directives.
Separation of regulated and non-regulated areas
The structures used in the non-regulated area (such as standardisation, accreditation, conformity assessment, etc.) may also be used for the purposes of regulation in the New Approach area. The lack of a legal basis in the non-regulated area has created, in some cases, a dichotomy in the activities of the relevant bodies, which are often active in both the regulated and the non-regulated areas. The Commission therefore considers that no distinction should be made between the regulated and non-regulated areas.
Cooperation and exchange of information
Although certain New Approach Directives require notified bodies actively to exchange information on the denial or withdrawal of certificates, this does not prevent some manufacturers from submitting non-compliant products to other Member States' bodies for certification. The Commission proposes to introduce provisions for notified bodies to exchange information on non-compliant products submitted for certification into all New Approach Directives.
CONFORMITY ASSESSMENT PROCEDURES
The various evaluation procedures introduced by the Council Decision on the CE conformity marking have proved their effectiveness. Problems may arise if one product is covered by more than one directive, in which case manufacturers have to call on several notified bodies for conformity assessment, which increases the cost of certification. Modules H, E and D (declaration of conformity with the aid of quality schemes) enable manufacturers to reduce the frequency of notified bodies' intervention. The Commission proposes:
- the introduction of modules H, E or D into existing and future New Approach Directives where appropriate;
- the preparation of a proposal, for horizontal application, clarifying the definitions to be applied in conformity assessment procedures.
CE conformity marking
The Member States and the Commission must increase their efforts to clarify the meaning of the CE marking to consumers; the marking indicates that all the requirements of the relevant directives have been met. The Commission also intends to look further into the problem of abuse of CE marking. An information campaign will be launched in close cooperation with the Member States.
ENFORCEMENT AND MARKET SURVEILLANCE
Market surveillance is the responsibility of national authorities. At present, strict separation between designating authorities, accreditation bodies, conformity assessment bodies and market surveillance authorities is not always guaranteed. This potential source of conflict of interests needs to be eliminated.
Establishing a common level of market surveillance
Member States can achieve a common level of market surveillance based on the following criteria:
- adequate infrastructures and human resources;
- a strategic market surveillance programme based on analysis of accident data;
- dissuasive penalties proportionate to the degree of non-compliance;
- effective communication and co-ordination between market surveillance authorities and the other players (occupational health and safety and customs authorities, etc.);
- full participation by national authorities in administrative co-operation with their counterparts in other Member States, particularly in exchanging information.
The Commission considers that defining basic rules with which Member States will be obliged to comply requires a revision of the legal framework by means of a horizontal directive or by including these rules in the individual directives.
Closer administrative cooperation
Market surveillance must be accompanied by effective cross-border administrative co-operation. The Commission proposes the following means of reinforcing cooperation:
- mutual assistance between Member States' authorities in carrying out market surveillance activities;
- a clearer operational framework for the administrative cooperation groups made up of the national authorities responsible for market surveillance;
- faster exchange of information on non-compliant products to all national authorities (particularly using the Interchange of Data between Administrations (IDA) programme);
- public access to information on dangerous products (identifying the product, the nature of the risk and the measures taken, etc.);
- spreading best practices by cooperation.
The Member States are obliged to take restrictive measures against products which are found to be unsafe. The mere absence of CE marking on a product which should carry it, allows a surveillance authority to rule the product non-compliant. The safeguard clause procedure provided for in the directives allows the Commission to check the grounds for national measures which aim to restrict the free movement of goods bearing the CE marking.
This procedure is cumbersome and difficult to put into practice. The Commission proposes to amend the safeguard clause procedure by revising the legal framework in order to guarantee a more uniform approach for all the directives.
The General Product Safety Directive
The General Product Safety Directive has implications for consumer products covered by the New Approach Directives. The safety requirements of the GPSD do not, however, apply to those products covered by the New Approach. Only the enforcement provisions of the General Product Safety Directive apply to the products covered by New Approach legislation, which means that industrial and consumer products could be subject to different market surveillance provisions. The Commission proposes to introduce provisions into the New Approach Directives for exchanging information on industrial products that present a serious and immediate risk to users.
CONSISTENT AND EFFECTIVE IMPLEMENTATION OF NEW APPROACH DIRECTIVES
Revision of the legal framework
One option for making the necessary changes is to incorporate the appropriate requirements into all the sectoral directives. Since not all risks are dealt with by the same directives, products may be governed by several directives, which can pose a number of problems, and in particular:
- unintentional differences in sectoral New Approach Directives;
- the application of different procedures according to the directives;
- new types of modules created by certain New Approach Directives could lead to problems with other provisions in other directives which apply to the same product.
The Commission proposes to begin examining the benefits and disadvantages of drafting a common base directive and the inclusion of standard articles on horizontal issues in New Approach Directives.
The implementation of New Approach Directives places a significant administrative burden on the Member States and the Commission. The Commission, together with the Member States, will examine all the options available, including more regular use of external consultants and the outsourcing of certain operations to a body of technical experts competent in the relevant field.
The New Approach is based on the Council Resolution of 7 May 1985 which provided a new framework for the harmonisation of national regulations on industrial products and thus facilitated the achievement of the internal market. This resolution was complemented in 1989 by a new Council resolution on a global approach to conformity assessment. The Council then drew up two other decisions establishing more detailed specifications for testing and certification procedures, and also for the CE conformity marking.