Council Decision
of 4 April 2001
on the conclusion of a Protocol to the Europe Agreement establishing an Association between the European Communities and their Member States, of the one part, and the Republic of Hungary, of the other part, on Conformity Assessment and Acceptance of Industrial Products (PECA)
(2001/366/EC)
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 133 thereof, in conjunction with the first sentence of the first subparagraph of Article 300(2), the first sentence of the first subparagraph of Article 300(3) and Article 300(4) thereof,
Having regard to the proposal from the Commission,
Whereas:
(1) The Europe Agreement establishing an association between the European Communities and their Member States, of the one part, and the Republic of Hungary, of the other part(1), hereinafter referred to as the "Europe Agreement", entered into force on 1 February 1994.
(2) Article 73(2) of the Europe Agreement provides that cooperation in the fields of standardisation and conformity assessment shall seek to achieve, amongst other things, the conclusion of agreements on mutual recognition.
(3) Article 108(2) of the Europe Agreement provides that the Association Council may delegate to the Association Committee any of its powers.
(4) Article 2 of Decision 93/742/Euratom, ECSC, EC, of the Council and the Commission of 13 December 1993 on the conclusion of the Europe Agreement(2), provides for the Community decision-making procedures and for the presentation of the Community position in the Association Council and in the Association Committee.
(5) Article 14 of Decision No 1/94 of the Association Council between the European Communities and their Member States, of the one part, and the Republic of Hungary, of the other part of 7 March 1994 on its rules of procedure(3) provides that the Association Committee may set up further subcommittees or groups to assist in carrying out its duties.
(6) The Protocol to the Europe Agreement, on Conformity Assessment and Acceptance of Industrial Products, was signed on behalf of the Community in Brussels on 26 February 2001 and should be approved.
(7) Certain tasks for implementation have been conferred upon the Association Council, and in particular, the power to amend the Annexes to the Protocol.
(8) The appropriate internal procedures should be established to ensure the proper functioning of the Protocol.
(9) It is necessary to empower the Commission to make certain technical amendments to the Protocol and to take certain decisions for its implementation,
HAS DECIDED AS FOLLOWS:
Article 1
The Protocol to the Europe Agreement, on Conformity Assessment and Acceptance of Industrial Products (hereinafter referred to as "the Protocol"), as well as the declaration annexed to the Final Act thereto, are hereby approved on behalf of the Community.
The text of the Protocol, and of the declaration annexed to the Final Act thereto is attached to this Decision.
Article 2
The President of the Council shall, on behalf of the Community, transmit the diplomatic note provided for in Article 17 of the Protocol.
Article 3
1. After consultation with the special committee appointed by the Council, the Commission shall:
(a) carry into effect the notifications, acknowledgements, suspensions and withdrawals of bodies, and appointments of joint team or teams of experts, in accordance with Articles 10, 11 and 14(c), of the Protocol, and Section IV of the Good Laboratory Practice (GLP) Annex and Section III of the Good Manufacturing Practice (GMP) Annex to the Protocol;
(b) bring about the consultations, exchange of information, the requests for verifications and for participation in verifications, in accordance with Articles 3, 12 and 14(d), (e), and Section II of the GLP Annex and Sections III and IV of the Annexes to the Protocol concerning machinery, electrical safety, electromagnetic compatibility, hot water boilers, gas appliances, medical devices, GLP and GMP;
(c) if necessary, reply to requests in accordance with Article 11, Sections III and IV of the Annexes to the Protocol concerning machinery, electrical safety, electromagnetic compatibility, hot-water boilers, gas appliances, medical devices, GLP and GMP.
2. Following consultation of the special committee referred to in paragraph 1, the Commission shall determine the position to be taken by the Community in the Association Council and, where applicable, in the Association Committee, with regard to:
(a) amendments to the Annexes in accordance with Article 14 point (a) of the Protocol;
(b) any decisions regarding disagreements on the results of the verifications and the suspensions, in part or totally, of any notified body in accordance with the second and third subparagraphs of Article 11 of the Protocol;
(c) any measures taken in the application of the safeguard clauses in Section IV of the Annexes of the Protocol concerning machinery, electrical safety, electromagnetic compatibility, hot-water boilers, gas appliances, medical devices and GLP;
(d) the entry into operation of the Sectoral Annex on GLP for medicinal products, in accordance with section IV thereof;
(e) the pre-operational phase and the measures to be taken in accordance with points 3.3, 3.4, 4.12, 4.17 and 5.1 of Section III of the GMP Annex to the Protocol;
(f) any measures concerning the verification, suspension, or withdrawal of industrial products as having mutual acceptance under Article 4 of the Protocol.
3. In all other cases, the position to be taken by the Community in the Association Council and, where applicable, in the Association Committee, with regard to this Protocol shall be determined by the Council, acting by qualified majority on a proposal from the Commission.
Done at Luxembourg, 4 April 2001.