CELEX: 
Language: en
Date: 2022-04-22
Title: COMMISSION IMPLEMENTING REGULATION (EU) …/... laying down rules for the application of Regulation (EU) 2016/429 of the European Parliament and of the Council with regard to registration and approval of establishments keeping terrestrial animals and collecting, producing, processing or storing germinal products

COMMISSION IMPLEMENTING REGULATION (EU) …/...
            
            
               of XXX
            
            
               laying down rules for the application of Regulation (EU) 2016/429 of the European Parliament and of the Council with regard to registration and approval of establishments keeping terrestrial animals and collecting, producing, processing or storing germinal products
            
            
               (Text with EEA relevance)
            
            
               THE EUROPEAN COMMISSION,
            
            
               Having regard to the Treaty on the Functioning of the European Union,
            
            
               Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council on transmissible animal diseases and amending and repealing certain acts in the area of animal health ('Animal Health Law')
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               , and in particular Article 86(1) and (2) and Article 96(3) thereof,
            
            
               Whereas:
            
            
               (1)Regulation (EU) 2016/429 lays down rules for animal diseases that are transmissible to animals or humans, including rules on the registration and approval by the competent authority of establishments keeping terrestrial animals and collecting, producing, processing or storing germinal products. 
            
            
               (2)Commission Delegated Regulation (EU) 2019/2035
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                supplements Regulation (EU) 2016/429 by laying down detailed rules concerning the registers to be kept by the competent authority of registered and approved establishments keeping terrestrial animals and collecting, producing, processing or storing germinal products registered with it or approved by it.
            
            
               (3)More particularly, Article 18, point (d), of Delegated Regulation (EU) 2019/2035 provide that the competent authority is to include in its register of establishments of kept terrestrial animals and of hatcheries registered with it the address and geographical coordinates (latitude and longitude) of the location of the establishment. Furthermore, Article 18, point (h), of Delegated Regulation (EU) 2019/2035 provide that the competent authority is to include in that register information about the period during which animals or  hatching eggs are kept on the establishment if it is not continuously occupied, including seasonal occupation or occupation during particular events. While Article 84(1), point (b), of Regulation (EU) 2016/429 provides that operators of establishments keeping terrestrial animals or collecting, producing, processing or storing germinal products are to provide the competent authority with certain information in order for their establishments to be registered, that information does not include all the detailed information required under Article 18, points (d) and (h), of Delegated Regulation (EU) 2019/2035. It is therefore appropriate to lay down a requirement for the operators of establishments of kept terrestrial animals and of hatcheries to provide such detailed information to the competent authority for the purpose of registration.
            
            
               (4)Similarly, Article 21, points (d) and (h), of Delegated Regulation (EU) 2019/2035 also provide that the competent authority is to include in its register of establishments approved by it the same detailed information required by Article 18, points (d) and (h), of that Delegated Regulation. While Article 96(1) of Regulation (EU) 2016/429 requires operators to provide the competent authority with certain information for the purposes of their application for approval of their establishment, that information does not include all the detailed information required under Article 21, points (d) and (h), of Delegated Regulation (EU) 2019/2035. It is therefore appropriate to lay down a requirement for the operators of establishments of kept terrestrial animals and hatcheries to provide such detailed information to the competent authority for the purpose of approval.
            
            
               (5)In addition, Article 85 of Regulation (EU) 2016/429 provides that Member States may, by way of derogation from Article 84(1) of that Regulation, exempt from the registration requirement certain categories of establishments posing an insignificant risk to animal or public health. Such exemptions may only be granted if those categories of establishments are of a type falling under the rules laid down in an implementing act adopted in accordance with Article 86(2) of that Regulation. Rules concerning the types of establishments posing an insignificant risk that may be exempted by the Member States from the registration requirement in accordance with Article 85 should be laid down.
            
            
               (6)Certain establishments, in particular those keeping ungulates can not be considered as posing an insignificant risk due to a number of listed diseases that may transmit and which may affect health status of establishments or zones in that respect. Similarly, dogs, cats and ferrets kept on an establishment for breeding purposes pose a more than insignificant risk, especially for human health perspective. In this regard, it should be noted that households where dogs, cats and ferrets are kept for private non-commercial purposes do not fall within the definition of an “establishment”.
            
            
               (7)The movement of animals, germinal products and products of animal origin constitutes the most important risk factor for animal and human health, and establishments where animals, germinal products or products of animal origin are kept with the primary aim of certain continuity and a certain degree of movement of those animals, germinal products or products of animal origin out of the establishment should not be considered as posing an insignificant risk.
            
            
               (8)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
            
            
               HAS ADOPTED THIS REGULATION:
            
            
               Article 1
            
            
               Subject matter and scope
            
         
         
            
               This Regulation lays down rules concerning:
            
            
               (a)the information to be provided by operators of establishments of kept terrestrial animals and of hatcheries for the purpose of the registration of their establishments, as provided for in Article 84(1) of Regulation (EU) 2016/429;
            
            
               (b)the types of establishments keeping terrestrial animals posing an insignificant risk that may be exempted by the Member States from the registration requirement in accordance with Article 85 of Regulation (EU) 2016/429;
            
            
               (c)the information to be provided by operators of establishments of kept terrestrial animals and of hatcheries in their application for approval of their establishment in accordance with Article 96(1) of Regulation (EU) 2016/429.
            
            
               Article 2
            
            
               Information to be provided by operators for the purpose of the registration of their establishment
            
            
               Operators of establishments of kept terrestrial animals and of hatcheries referred to in Article 84(1) of Regulation (EU) 2016/429 shall, in addition to the information referred to in Article 84(1), point (b), of that Regulation, before they commence such activities, provide the competent authority with the following information:
            
            
               (a)the address and geographical coordinates (latitude and longitude) of the location of the establishment to be registered;
            
            
               (b)the period during which animals or hatching eggs are kept on the registered establishment if it is not continuously occupied, including seasonal occupation or occupation during particular events.
            
            
               Article 3
            
            
               Types of establishments keeping terrestrial animals that may be exempted by the Member States from the registration requirement
            
            
               1.Member States may exempt from the registration requirement establishments keeping terrestrial animals posing an insignificant risk, as provided for in Article 85 of Regulation (EU) 2016/429, if the following criteria are fulfilled:
            
            
               (a)no ungulates are kept on the establishment;
            
            
               (b)no dogs, cats or ferrets are kept for breeding on the establishment;
            
            
               (c)animals entering the establishment are sourced from establishments registered or approved by the competent authority within the same Member State;
            
            
               (d)no animals or germinal products are moved from the establishment to any other establishment, in the same Member State or in another Member State;
            
            
               (e)no animals, germinal products or products of animal origin are kept on the establishment for the purpose of any transfer, whether free of charge or not.
            
            
               2.Member States that exempt establishments in accordance with paragraph 1 may lay down additional criteria regarding limitations on the number of terrestrial animals that can be kept on such establishments and restrict the geographical location of those establishments, in particular in relation to their proximity to establishments registered or approved by the competent authority.
            
            
               Article 4
            
            
               Information to be provided by operators in their application for approval of their establishment
            
         
         
            
               Operators of establishments of kept terrestrial animals and of hatcheries shall, for the purposes of their application for approval of their establishment as provided for in Article 94(1) and Article 95, point (a) 95 of Regulation (EU) 2016/429, in addition to the information referred to in Article 96(1) of that Regulation, provide the competent authority with the following information:
            
            
               (a)the address and geographical coordinates (latitude and longitude) of the location of the establishment to be approved;
            
            
               (b)the period during which animals or hatching eggs are kept on the approved establishment if it is not continuously occupied, including seasonal occupation or occupation during particular events.
            
            
               Article 5
            
            
               Entry into force 
            
            
               This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
            
            
               This Regulation shall be binding in its entirety and directly applicable in all Member States.
            
            
               Done at Brussels,
            
            
               
                     For the Commission
               
               
                     The President
               
               
                     Ursula VON DER LEYEN