Council Resolution

of 10 November 2003

on the Communication of the European Commission "Enhancing the Implementation of the New Approach Directives"

(2003/C 282/02)

THE COUNCIL OF THE EUROPEAN UNION,

RECALLING its objectives laid down in its Decision of 22 July 1993 (93/465/EEC)(1) and its Resolutions of 7 May 1985 on a New Approach to technical harmonization and standards(2), of 21 December 1989 on a Global Approach to conformity assessment(3) and of 28 October 1999 on the role of standardisation in Europe(4), and its Conclusion of 1 March 2002 on standardisation(5);

ACKNOWLEDGING the importance of the New and Global Approach as an appropriate and efficient regulatory model, allowing technological innovation and enhancing competitiveness of European industry, as well as supporting the principles of confidence, transparency and competence;

UNDERLINING its continued support of the efforts undertaken by the Commission, both on international and regional/bilateral platforms, to harness and develop the potential of the New Approach principles for the effective protection of e.g. health and safety and removal of technical barriers to trade, and to encourage trading partners to adopt standards and regulatory approaches compatible with the European Union's regulatory framework;

CONFIRMING its commitment to further improving the operational efficiency of the internal market and reinforcing the competitiveness of European industry, and TAKING NOTE of the extensive consultations and discussions involving all stakeholders as well as national authorities of Member States;

RECOGNISING the need for a clearer framework for conformity assessment, accreditation and market surveillance in the European Union;

RECOGNISING the value of a shared understanding of Member States' responsibilities for the operation of the New and Global Approaches, and the need for the accountability of Member States in fulfilling their responsibilities together with their rights to devise the means of doing so;

CONFIRMING the necessity for the Commission and the Member States to take all appropriate steps to further strengthen and enhance the implementation of Directives based on the principles of the New and Global Approaches in all Member States and to extend the application of those principles to new areas;

WELCOMES the Commission's Communication on "Enhancing the Implementation of the New Approach Directives" and the objectives contained therein;

INVITES THE COMMISSION:

To propose appropriate initiatives in the fields of conformity assessment and of market surveillance, and in particular:

(a) With respect to bodies performing conformity assessment tasks under the New Approach Directives and to bodies and authorities involved in the assessment, designation and surveillance of conformity assessment bodies:

1. To take steps towards ensuring that all notified bodies perform their functions to the same level and under conditions of fair competition, including measures:

- to consolidate the requirements with which the notified bodies must comply such as exchange of experience, exchange of information related to withdrawal or refusal of certificates and requirements for the cross-border activities of notified bodies;

- to establish and support appropriate procedures for the exchange of information between notified bodies which shall respect the principle of business confidentiality and shall not restrict competition between notified bodies;

- to consolidate the requirements that bodies involved in the designation, assessment and monitoring of notified bodies have to fulfil.

2. To support the establishment of a forum of Member States' authorities responsible for policy on designation, in order to facilitate the exchange of best practices for the assessment, designation and surveillance of notified bodies.

3. To establish an efficient information exchange procedure between designating authorities and accreditation bodies that have assessed conformity assessment bodies in all Member States, EEA and other countries to allow a reinforced administrative cooperation;

4. To increase the efficiency and transparency of the notification procedure, considering notably the development of an on-line notification system, made available by the Commission, with the aim to replace the existing paper-based system, including the availability of an updated list of notified bodies and of conformity assessment bodies;

5. To develop more comprehensive policy and guidance for the definition (including its role in the designation procedure) and use of accreditation with the aim of increasing coherence, transparency and co-operation of accreditation services within the European Union, in both the regulatory and voluntary areas, taking into account the freedom of operators in the non-regulated area to use them, as well as the relevant international aspects. The development of such a policy should include, in particular, the independence of accreditation bodies from commercial conformity assessment activities and, as a service of general economic interest, the avoidance of competition between different bodies. Consideration should be given to including such provisions in the general legislative framework for the New Approach.

(b) With respect to market surveillance and CE-marking:

1. To consider with Member States essential requirements defining the objectives to be achieved by the Member States with regard to market surveillance and to introduce in New Approach legislation a framework for the relevant administrative co-operation, including the exchange of information among Member States.

2. To improve the safeguard clause procedure foreseen in the New Approach legislation in order to increase transparency and to reduce processing time, with the aim to make it more efficient and uniformly applied and to draw on expertise available in Member States.

3. To start, in co-operation with Member States, EEA States and other countries having concluded agreements with the European Union on the use of the CE marking in their territories, as well as European stakeholders, a campaign to better promote and clarify the meaning of the CE marking and its relation to voluntary marks.

To introduce measures on the protection of the CE marking.

(c) On General measures:

1. To propose measures to clarify and to harmonise the definitions of a horizontal nature with a view to their coherent application, through the inclusion of aspects applicable to all sectors in a single legislative text.

2. To consider, in view of the enlarged Union and of a strengthened application of the Directives, the means that would allow to pool scarce technical expertise and ensure efficiency of the decision - making process.

3. To ensure, in co-operation with Member States, a consistent application of conformity assessment procedures to products covered by more than one Directive, by considering whether a more consistent range of modules can be made available in the individual Directives and ensuring that then only standard modules are used. The suppliers' declaration of conformity should be used whenever feasible.

(1) Council Decision of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for affixing and use of the CE conformity marking, which are intended to be used in the technical harmonization Directives (93/465/EEC) (OJ L 220, 30.8.1993, p. 23).

(2) OJ C 136, 4.6.1985.

(3) OJ C 10, 16.1.1990.

(4) OJ C 141, 19.5.2000.

(5) OJ C 66, 15.3.2002.