CELEX: 
Language: en
Date: 2006-03-10 00:00:00
Title: 2006/198/EC: 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#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

10.3.2006   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 71/11
            
         
      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
      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
         
      
      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
                        
                        
                           US standards
                        
                        
                           EC standards
                        
                     11.   Fisheries products for human consumption
                        
                     
                           
                        
                     
                           
                                       —
                                    
                                    
                                       Fish/fisheries products
                                    
                                 
                        
                           91/67
                        
                        
                           USDI & Title 50
                        
                        
                           NE
                        
                        
                            
                        
                        
                            
                        
                        
                           USDI & Title 50
                        
                        
                           91/67
                        
                        
                           NE
                        
                        
                            
                        
                        
                           EC to evaluate new US standards if applicable.
                        
                     
                           
                                       —
                                    
                                    
                                       Bivalve molluscs/crustaceans (excl. live)
                                    
                                 
                        
                           91/67
                        
                        
                           USDI & Title 50
                        
                        
                           NE
                        
                        
                            
                        
                        
                            
                        
                        
                           USDI & Title 50
                        
                        
                           91/67
                        
                        
                           NE
                        
                        
                            
                        
                        
                            
                        
                     
                           
                        
                     
                           
                                       —
                                    
                                    
                                       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
                        
                        
                           NE
                        
                        
                            
                        
                        
                            
                        
                        
                           National shellfish sanitation programme, FFDCA, FIFRA, PHSA, 21 CFR
                           110.3-110.93, 123, 1240, DVM
                        
                        
                           91/493
                           96/22
                           96/23
                        
                        
                           NE’