COMMISSION DECISION

of 2 February 2006

approving on behalf of the European Community amendments to the annexes to the Agreement between the European Community and the United States of America on sanitary measures to protect public and animal health in trade in live animals and animal products

(notified under document member C(2006) 81)

(Text with EEA relevance)

(2006/198/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Decision 98/258/EC of 16 March 1998 on the conclusion of the Agreement between the European Community and the United States of America on sanitary measures to protect public and animal health in trade in live animals and animal products (1), and in particular Article 4, third paragraph thereof,

Whereas:

(1) The Joint Management Committee for the Agreement (the Committee), at its meeting on 27 October 2005 issued a recommendation concerning the determination of equivalence for fishery products. As a result of this recommendation it is appropriate to amend Annex V to the Agreement.

(2) This amendment should be approved on behalf of the Community.

(3) The measure provided for in this Decision is in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS DECIDED AS FOLLOWS:

Article 1

Pursuant to the recommendation made by the Joint Management Committee established under Article 14 of the Agreement between the European Community and the United States of America on sanitary measures to protect public and animal health in trade in live animals and animal products, the amendments to Annex V to the said Agreement are hereby approved on behalf of the European Community. The text of the Agreement in the form of an Exchange of Letters, including the amendments to Annex V to the Agreement, is attached to this Decision.

Article 2

The Director-General for Health and Consumer Protection is hereby empowered to sign the agreement in the form of an exchange of letters in order to bind the Community.

Article 3

This Decision shall apply from the first day of the month following the month in which the United States of America notifies the Commission in writing that its internal procedures for the approval of the amendments referred to in Article 1 have been completed.

Done at Brussels, 2 February 2006.

For the Commission

Markos KYPRIANOU

Member of the Commission

(1)

OJ L 118, 21.4.1998, p. 1

AGREEMENT

in the Form of an Exchange of Letters concerning amendments to the annexes to the Agreement between the European Community and the United States of America on sanitary measures to protect public and animal health in trade in live animals and animal products

A. Letter from the European Community

Brussels, 30 January 2006

Sir,

With reference to the Agreement between the European Community and the United States of America on sanitary measures to protect public and animal health in trade in live animals and animal products, I have the honour to propose to you to amend the Annexes the Agreement as follows:

Replace the text of Annex V, point 11 of the Agreement, as recommended by the Joint Management Committee established under Article 14(1) of the Agreement with the respective text of Appendix A as attached hereto.

I would be obliged if you would confirm the Agreement of the United States of America to such amendment of Annex V to the Agreement.

Please accept, Sir, the assurance of my highest consideration.

For the European Community

Jaana HUSU-KALLIO

B. Letter from the United States of America

Brussels, 1 February 2006

Sir,

I have the honour to refer to your letter containing details of proposed amendments to Annex V, point 11 of the Agreement between the European Community and the United States of America on sanitary measures to protect public and animal health in trade in live animals and animal products.

In this regard I have the honor to confirm the acceptability to the United States of America of the proposed amendments as recommended by the Joint Management Committee established under Article 14(1) of the Agreement, a copy of which is attached hereto. It is my understanding that these amendments shall take effect on the date on which the EC notifies the US that it has completed the necessary procedures for implementing these amendments.

Please accept, Madam, the assurances of my high consideration.

For the competent authority of the United States of America

Norval E. FRANCIS

Appendix A

‘ANNEX V

—

Commodity

—

Species

—	Animal/public health

European Community exports to the United States

United States exports to the European Community

Trade conditions

Equivalence (Category)

Special conditions

Actions

Trade conditions

Equivalence (Category)

Special conditions

Actions

EC standards

US standards

EC standards

11.

Fisheries products for human consumption

—	Fish/fisheries products

91/67

USDI & Title 50

91/67

EC to evaluate new US standards if applicable.

—	Bivalve molluscs/crustaceans (excl. live)

91/67

USDI & Title 50

91/67

—	Fish/fisheries products

91/493

96/22

96/23

21 CFR

123, 1240

FFDCA, FIFRA, PHSA, 21 CFR

70-82, 180, 110.3-110.93, 113, 114, 123, 172-193, 1240

Yes 3

Low-acid canned food requirement.

US to provide a detailed indication of how the EC request for equivalence for low-acid canned food can be considered.

EC to provide (1) appropriate information and documentation on procedures for audit and control of implementation by Member States, and (2)

information on application of HACCP systems in Member States.

21 CFR

123, 1240

FFDCA, FIFRA, PHSA, 21 CFR

70-82, 180, 110.3-110.93, 113, 114, 123, 172-193, 1240

91/493

96/22

96/23

Yes 2

[SANCO/10169/2005] Rev 3

—	Fish/fisheries products (cont’d)

US to conduct on-site verification of EC system (including visit to EC central offices and observation of Commission audits of a number of Member States).

US to indicate any outstanding problems following above actions.

The outcome of the on-site verification to be discussed with EC. If on-site verification satisfactory, the equivalence determination to be finalised, and any necessary procedures carried out.

NMFS Voluntary HACCP based programme 50 CFR 260

Yes 1

—	Bivalve molluscs/crustaceans (excl. live)

91/492

National shellfish sanitation programme

Yes 3

Existing trade conditions.

EC to supply the raw data used for the scientific assessment on flesh/water testing. US shall respond to results of scientific assessment within 90 days of receipts of raw data.

EC to provide (1) appropriate information and documentation on procedures for audit and control of implementation by Member States, and (2) information on application of HACCP systems in Member States.

US to conduct on-site verification of EC system (including visit to EC central offices and observation of Commission audits of a number of Member States).

US to indicate any outstanding problems following above actions.

The outcome of the on-site verification to be discussed with EC. If on-site verification satisfactory, the equivalence determination to be finalised, and any necessary procedures carried out.

National shellfish sanitation programme

91/492

Yes 3

Existing trade conditions.

Joint comparison of flesh/water testing for classification of production areas.

US to inform the EC when the US is ready to have the implementation of its seafood HACCP Regulation reviewed.

EC to carry out review, involving as necessary examination of information and documentation to be provided by US on procedures for audit and control of implementation. On-site verification of US system to be carried out within six months of US request.

EC to indicate any outstanding problems following above actions within 45 days of on-site verification.

The outcome of the on-site verification to be discussed with EC. If on-site verification satisfactory, the equivalence determination to be finalised, and any necessary procedures carried out.

“Establishments” do not include “brokers or traders”.

—	Aquaculture animals and products

91/493

96/22

96/23

National shellfish sanitation programme, FFDCA, FIFRA, PHSA, 21 CFR

110.3-110.93, 123, 1240, DVM

National shellfish sanitation programme, FFDCA, FIFRA, PHSA, 21 CFR

110.3-110.93, 123, 1240, DVM

91/493

96/22

96/23

NE’