Commission Delegated Regulation (EU) 2020/692 of 30 January 2020 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin (Text with EEA relevance) (Text with EEA relevance)
Modified by
Commission Delegated Regulation (EU) 2021/1703of 13 July 2021amending Delegated Regulation (EU) 2020/692 as regards the animal health requirements for the entry into the Union of products of animal origin contained in composite products(Text with EEA relevance), 32021R1703, September 24, 2021
Commission Delegated Regulation (EU) 2021/1705of 14 July 2021amending Delegated Regulation (EU) 2020/692 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin(Text with EEA relevance), 32021R1705, September 24, 2021
Commission Delegated Regulation (EU) 2020/692of 30 January 2020supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin(Text with EEA relevance)PART IGENERAL RULESTITLE 1SUBJECT MATTER, SCOPE AND DEFINITIONSArticle 1Subject matter and scope1.This Regulation lays down supplementing animal health rules concerning the entry into the Union of consignments of certain species and categories of animals, germinal products and products of animal origin from third countries or territories or zones thereof, or compartments in the case of aquaculture animals. It also lays down rules concerning the movement and handling of those consignments after their entry in the Union.2.Part I lays down:(a)the obligations on the competent authority of Member States to permit the entry into the Union of consignments of animals, germinal products and products of animal origin of species and categories of animals covered by Parts II to VI (Articles 3 and 4);(b)the obligations on the operators regarding the entry into the Union, and the movement and handling after entry, of consignments of animals, germinal products and products of animal origin covered by Parts II to VI (Article 5);(c)the general animal health requirements for entry into the Union, and the movement and handling after the entry of the consignments referred to in points (a) and (b), and derogations from those general requirements, applicable to all the species and categories of animals, germinal products and products of animal origin covered by Parts II to VI (Articles 6 to 10).3.Part II lays down the general animal health requirements for entry into the Union, as well as the movement and handling after the entry, and derogations from such requirements for certain terrestrial animals (Title 1).In addition, it lays down specific animal health requirements that are also applicable to the each of those species and categories of terrestrial animals, in particular:(a)kept ungulates of listed species (Title 2);(b)poultry and captive birds, except captive birds imported for conservation programmes approved by the competent authority of the Member State of destination (Title 3);(c)honeybees (Apis mellifera) and bumble bees (Bombus spp.) (Title 4);(d)dogs, cats and ferrets (Title 5).4.Part III lays down the general animal health requirements for entry into the Union, as well as the movement and handling after the entry, and derogations from such requirements for germinal products of the following species and categories of kept terrestrial animals:(a)bovine, porcine, ovine, caprine and equine animals (Title 1);(b)poultry and captive birds (Title 2);(c)animals other than those listed in points (a) and (b) (Title 3).5.Part IV lays down the general animal health requirements for entry into the Union, as well as the movement and handling after the entry, and derogations from those requirements for products of animal origin of the following species and categories of terrestrial animals:(a)kept and wild ungulates of listed species;(b)poultry;(c)game birds.6.Part V lays down the animal health requirements for the entry into the Union, as well as the movement and handling after the entry, and derogations from those requirements for the following species of aquatic animals at all life stages as well as their products of animal origin, excluding products of animal origin other than live aquatic animals which are intended for direct human consumption and wild aquatic animals and products of animal origin from those wild aquatic animals landed from fishing vessels intended for direct human consumption:(a)fish of listed species belonging to the superclass Agnatha and to the classes Chondrichthyes, Sarcopterygii and Actinopterygii;(b)aquatic molluscs of listed species belonging to the phylum Mollusca;(c)aquatic crustaceans of listed species belonging to the subphylum Crustacea;(d)aquatic animals of species listed in Annex XXIX which are susceptible to the aquatic diseases for which certain Member States have national measures to limit the impact of diseases other than listed diseases, as provided for in Article 226 of Regulation (EU) 2016/429.7.Part VI lays down the general rules, certain derogations and additional requirements for transit through the Union and for the return to the Union of certain species and categories of animals, germinal products and products of animal origin.8.Part VII lays down transitional and final provisions.Article 2DefinitionsFor the purposes of this Regulation, the definitions laid down in Implementing Regulation (EU) 2018/1882 and Annex I to Regulation (EC) No 853/2004 shall apply, except where those definitions cover terms that are defined in the second paragraph of this Article.In addition, the following definitions shall also apply:(1)"listed third country, territory or zone thereof" means a third country, territory or zone thereof included in a list of third countries, territories or zones thereof, or compartments in the case of aquaculture animals, from which the entry into the Union of a particular species and category of animals, germinal products and products of animal origin is permitted in accordance with implementing acts adopted pursuant to Article 230(1) of Regulation (EU) 2016/429;(2)"the list" means the list of third countries, territories or zones thereof, or compartments in the case of aquaculture animals, authorised for entry into the Union of consignments of a particular species and category of animals, germinal products or products of animal origin by implementing acts adopted pursuant to Article 230(1) of Regulation (EU) 2016/429;(3)"means of transport" means road or rail vehicle, vessels and aircrafts;(4)"container" means any crate, box, receptacle or other rigid structure used for the transport of animals, germinal products or products of animal origin which is not the means of transport;(5)"bovine animal" means an animal of the species of ungulates belonging to the genera Bison, Bos (including the subgenera Bos, Bibos, Novibos, Poephagus) and Bubalus (including the subgenus Anoa) and the offspring of crossings of those species;(6)"ovine animal" means an animal of the species of ungulates belonging to the genus Ovis and the offspring of crossings of those species;(7)"caprine animal" means an animal of the species of ungulates belonging to the genus Capra and the offspring of crossings of those species;(8)"porcine animal" means an animal of the species of ungulates belonging to the family Suidae listed in Annex III to Regulation (EU) 2016/429 for the purpose of entry into the Union of an animal or an animal of the species Sus scrofa, for the purpose of entry into the Union of germinal products;(9)"equine animal" means an animal of species of solipeds belonging to the genus Equus (including horses, asses, and zebras) and the offspring of crossings of those species;(10)"camelid animal" means an animal of the species of ungulates belonging to the family Camelidae listed in Annex III to Regulation (EU) 2016/429;(11)"cervid animal" means an animal of the species of ungulates belonging to the family Cervidae listed in Annex III to Regulation (EU) 2016/429;(12)"registered equine animal" means:(a)a purebred breeding animal of the species Equus caballus and Equus asinus entered or eligible for entry in the main section of a breeding book established by a breed society or breeding body recognised in accordance with Article 4 or 34 of Regulation (EU) 2016/1012;(b)a kept animal of the species Equus caballus registered with an international association or organisation, either directly or through its national federation or branches, which manages horses for competition or racing ("registered horse");(13)"animals intended for slaughter" means kept terrestrial animals to be transported, either directly or after undergoing an assembly operation, to a slaughterhouse;(14)"disease has not been reported" means that no animal or group of animals of relevant species kept on the establishment has been classified as a confirmed case of that disease and any suspect case of that disease has been ruled out;(15)"sanitary group" means a group of listed third countries in which common animal health risks as regards diseases listed for equine animals prevail that require specific risk-mitigating measures and health guarantees when equine animals enter into the Union;(16)"flock" means all poultry or captive birds of the same health status kept on the same premises or in the same enclosure and constituting a single epidemiological unit; in housed poultry, this includes all birds sharing the same airspace.(17)"breeding poultry" means poultry 72 hours old or more, intended for the production of hatching eggs;(18)"productive poultry" means poultry 72 hours old or more, reared for the production of meat, eggs for consumption or other products or for restocking supplies of game birds;(19)"day-old chicks" means poultry less than 72 hours old;(20)"honeybee" means an animal of the Apis mellifera species;(21)"bumble bee" means an animal of the species belonging to the genus Bombus;(22)"dog" means a kept animal of the Canis lupus species;(23)"cat" means a kept animal of the Felis silvestris species;(24)"ferret" means a kept animal of the Mustela putorius furo species;(25)"unique approval number" means a number assigned by the competent authority;(26)"specified pathogen-free eggs" means hatching eggs derived from "chicken flocks free from specified pathogens", as described in the European Pharmacopoeia and which are intended solely for diagnostic, research or pharmaceutical use;(27)"consignment of semen, oocytes or embryos" or "consignment of germinal products" means a quantity of semen, oocytes, in vivo derived embryos or in vitro produced embryos dispatched from a single approved germinal product establishment covered by a single animal health certificate;(28)"semen" means the ejaculate of an animal or animals, either in the unaltered state or prepared or diluted;(29)"oocytes" means the haploid stages of the ootidogenesis including secondary oocytes and ova;(30)"embryo" means the initial stage of development of an animal while it is capable of being transferred to a recipient dam;(31)"approved germinal product establishment" means a semen collection centre, an embryo collection team, an embryo production team, a germinal product processing establishment or a germinal product storage centre;(32)"centre veterinarian" means the veterinarian responsible for the activities carried out at the semen collection centre, at the germinal product processing establishment or at the germinal product storage centre as provided for in this Regulation;(33)"team veterinarian" means the veterinarian responsible for the activities carried out by an embryo collection team or by an embryo production team as provided for in this Regulation;(34)"quarantine accommodation" means a facility authorised by the competent authority for the purpose of the isolation of bovine, porcine, ovine or caprine animals for a period of at least 28 days before they are admitted to a semen collection centre;(35)"semen collection centre" means a germinal product establishment approved by the competent authority for the collection, processing, storage and transport of semen of bovine, porcine, ovine, caprine or equine animals intended for entry into the Union;(36)"embryo collection team" means a germinal product establishment comprised of a group of professionals or structure approved by the competent authority for the collection, processing, storage and transport of in vivo derived embryos intended for entry into the Union;(37)"embryo production team" means a germinal product establishment comprised of a group of professionals or structure approved by the competent authority for the collection, processing, storage and transport of oocytes, and the in vitro production, where applicable with stored semen, processing, storage and transport of embryos, both intended for entry into the Union;(38)"germinal product processing establishment" means a germinal product establishment approved by the competent authority for the processing, including semen sex-sorting where appropriate, and the storage of semen, oocytes or embryos of one or more species, or any combination of those types of germinal products or species, intended for entry into the Union;(39)"germinal product storage centre" means a germinal product establishment approved by the competent authority for the storage of semen, oocytes or embryos of one or more species, or any combination of those types of germinal products or species, intended for entry into the Union;(40)"meat" means all parts of ungulates, poultry and game birds which are suitable for human consumption, including blood;(41)"fresh meat" means meat, minced meat and meat preparations, including vacuum-wrapped or wrapped in a controlled atmosphere, which has not undergone any preserving process other than chilling, freezing or quick-freezing;(42)"carcase of an ungulate" means the whole body of a slaughtered or killed ungulate after:(a)bleeding, in the case of slaughtered animals;(b)evisceration;(c)removal of the limbs at the carpus and tarsus;(d)removal of the tail, the udder, the head and the skin, except in porcine animals.(43)"offal" means fresh meat other than that of a carcase of an ungulate even if it remains naturally connected to the carcase;(44)"meat products" means processed products, including treated stomachs, bladders, intestines, rendered animal fats and meat extracts, resulting from the processing of meat or from the further processing of such processed products, so that the cut surface shows that the product no longer has the characteristics of fresh meat;(45)"casings" means the bladders and intestines that after cleaning have been processed by tissue scraping, defatting and washing and have been treated with salt or dried;(46)"colostrum" means the fluid secreted by the mammary glands of kept animals up to 3 to 5 days post-parturition that is rich in antibodies and minerals, and precedes the production of raw milk;(47)"colostrum-based products" means processed products resulting from the processing of colostrum or from the further processing of such processed products;(48)"well-boat" means a "well-boat" as defined in Article 2, point 2, of Commission Delegated Regulation (EU) 2020/990Commission Delegated Regulation (EU) 2020/990 of 28 April 2020 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council, as regards animal health and certification requirements for movements within the Union of aquatic animals and products of animal origin from aquatic animals (OJ L 221, 10.7.2020, p. 42).;(49)"IMSOC" means the information management system for official controls provided for in Article 131 of Regulation (EU) 2017/625Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1)..TITLE 2GENERAL ANIMAL HEALTH REQUIREMENTS FOR ENTRY INTO THE UNION, AND MOVEMENT AND HANDLING AFTER THE ENTRY OF CONSIGNMENTS OF ANIMALS, GERMINAL PRODUCTS AND PRODUCTS OF ANIMAL ORIGINArticle 3Obligations of the competent authorities of Member StatesThe competent authority shall permit the entry into the Union of consignments of animals, germinal products and products of animal origin of species and categories covered by Parts II to VI, which are presented for the purpose of official controls as provided for in Article 47(1) of Regulation (EU) 2017/625, provided that:(a)the consignments come from:(i)in the case of terrestrial animals, germinal products and products of animal origin, a listed third country or territory or zone thereof for the particular species and category of animals, germinal products and products of animal origin;(ii)in the case of aquatic animals, a listed third country or territory or zone thereof for the particular species and category of animals and products of animal origin, and in the case of aquaculture animals, a listed third country or territory or zone or compartment thereof listed for that purpose;(b)the competent authority of the third country or territory of origin has certified that the consignments comply with:(i)the general animal health requirements for entry into the Union of animals, germinal products and products of animal origin laid down in this Article, Article 4 and Articles 6 to 10;(ii)the animal health requirements applicable to the particular species and category of animals, germinal products and products of animal origin and intended use, as laid down in Parts II to VI;(c)the consignments are accompanied by the following documents whereby the competent authority of the third country or territory of origin has provided the necessary guarantees as regards compliance with the animal health requirements referred to in point (b):(i)an animal health certificate issued by an official veterinarian of the third country or territory of origin, specific for the particular species and category of animals, germinal products and products of animal origin and their intended use;(ii)a declaration and other documents, where required in this Regulation.In the case of consignments of animals and hatching eggs, the animal health certificate, referred to in point (c)(i) must have been issued within the period of 10 days prior to the date of arrival of the consignment at the border control post; however, in the case of transport by sea that period may be extended by an additional period corresponding to the duration of the journey by sea.Article 4The date of certification of consignments1.Consignments of animals, germinal products and products of animal origin of species and categories falling within the scope of this Regulation shall only be permitted to enter the Union provided that such consignments were certified for dispatch to the Union not earlier than the date on which the third country or territory of origin or zone thereof, or compartment thereof in the case of aquaculture animals, was listed for entry into the Union of the particular species and category of animals, germinal products and products of animal origin.2.Consignments of animals, hatching eggs and products of animal origin originating from a third country or territory or zone thereof, or compartment thereof in the case of aquaculture animals, shall not be permitted to enter the Union from the date on which it no longer complies with the animal health requirements for entry into the Union of the particular species and category of animals, hatching eggs or products of animal origin, unless specific conditions have been assigned by the Union in the list to the listed third country, territory or zone thereof and to the particular species and categories of animals, hatching eggs or products of animal origin.Article 5Obligations of operators1.Operators responsible for entry into the Union of consignments of animals, germinal products and products of animal origin of the species and categories falling within the scope of this Regulation, shall present those consignments to the competent authority in the Union for the purpose of official controls, as provided for in Article 47(1) of Regulation (EU) 2017/625, and shall ensure that such consignments comply with the following requirements:(a)the general animal health requirements for entry into the Union of the animals, germinal products and products of animal origin laid down in Articles 3 and 4 and Articles 6 to 10;(b)the animal health requirements applicable to the particular species and category of the animals, germinal products and products of animal origin of the consignment and its intended use, as laid down in Parts II to VI.2.Operators responsible for the movement of consignments of animals, germinal products and products of animal origin of the species and categories falling within the scope of this Regulation from the point of entry in the Union to their place of destination, and those responsible for the handling of such consignments after their entry into the Union shall ensure that the consignments:(a)are permitted to enter the Union by the competent authority in accordance with Article 3;(b)comply with the animal health requirements for the movement and handling of such consignments after the entry into the Union for the specific species and categories of animals, germinal products and products of animal origin laid down in Parts II to VI;(c)are not diverted for uses other than those for which they were certified by the competent authority of the third country or territory of origin for entry into the Union.Article 6National legislation and animal health systems of the third country or territory of origin1.Consignments of animals, germinal products and products of animal origin shall only be permitted to enter the Union from a third country or territory where:(a)any suspicion and confirmed case of a listed disease referred to in Annex I, relevant for the listed species of animals in the consignment or for the listed species of animals of origin of the germinal products or products of animal origin in the consignment authorised to enter the Union, are required by law to be notified and reported to the competent authority;(b)there are systems in place to detect emerging diseases;(c)there are systems in place to ensure that swill feeding is not a source of the listed diseases referred to in Annex I for:(i)the animals intended for entry into the Union;or(ii)the animals from which the germinal products intended for entry into the Union are obtained;or(iii)the animals from which the products of animal origin intended for entry into the Union are obtained.2.Consignments of animals, germinal products and products of animal origin intended for entry into the Union shall only be permitted to enter the Union from a third country or territory or zone thereof where such consignments may be lawfully placed on the market and traded in that third country or territory of origin or zone thereof.Article 7General requirements as regards the health status of the animals, germinal products and products of animal origin1.Consignments of animals shall only be permitted to enter the Union if the animals of the consignment:(a)are not animals to be killed under a national programme carried out in the third country or territory of origin for the eradication of diseases, including the relevant listed diseases referred to in Annex I and emerging diseases;(b)did not show symptoms of transmissible diseases at the time of loading for the dispatch to the Union;(c)originate from an establishment which, at the time of their dispatch from that establishment to the Union, was not subject to national restriction measures:(i)for animal health reasons;(ii)in the case of aquaculture animals, for animal health reasons or due to the occurrence of abnormal mortalities with an undetermined cause.2.Consignments of germinal products shall only be permitted to enter the Union if they were obtained from animals which at the time of collection:(a)did not show symptoms of transmissible diseases;(b)were kept on an establishment which was not subject to national restriction measures for animal health reasons, including restrictions related to the relevant listed diseases referred to in Annex I and emerging diseases.3.Consignments of products of animal origin shall only be permitted to enter the Union if they were obtained from animals which:(a)in the case of terrestrial animals, did not show symptoms of transmissible diseases at the time of:(i)killing or slaughter, for the production of fresh meat and meat products;or(ii)the collection of milk or eggs;(b)in the case of aquatic animals, did not show symptoms of transmissible diseases at the time of slaughter or collection for the production of products of animal origin.(c)were not killed, slaughtered or, in the case of molluscs and live crustaceans removed from the water, under a national programme for the eradication of diseases;(d)were kept on an establishment which was not subject to national restriction measures for animal health reasons, including where relevant, listed diseases referred to in Annex I and emerging diseases, at the time of:(i)the killing or slaughter of those animals for the production of fresh meat and meat products or products of animal origin from aquatic animals; or(ii)the collection of milk and eggs.Article 8General requirements as regards the establishment of origin of the animalsIn addition to the specific requirements laid down in Parts II to V, consignments of animals, germinal products and products of animal origin shall only be permitted to enter the Union if the establishment of origin of the kept animals, or the establishment of origin of the kept animals from which the germinal products or products of animal origin were obtained, complies with the following requirements:(a)it must be registered by the competent authority of the third country or territory of origin and assigned a unique registration number;(b)it must be approved by the competent authority of the third country or territory of origin, where required by and under the conditions provided for in this Regulation, and assigned a unique approval number;(c)it must be under the control of the competent authority of the third country or territory of origin;(d)it must have a system in place to maintain and to keep, for a minimum period of 3 years, up-to-date records containing at least the following information:(i)the species, categories, number and where relevant, identification of animals on the establishment;(ii)movements of animals into and out of the establishment;(iii)mortality in the establishment.(e)it must receive regular animal health visits from a veterinarian for the purpose of the detection of, and information on, signs indicative of the occurrence of diseases, including those listed diseases referred to in Annex I relevant for the particular species and category of animal, germinal product or product of animal origin and emerging diseases.Such animal health visits shall take place at frequencies that are proportionate to the risks posed by the establishment concerned.Article 9Sampling, laboratory tests and other testsConsignments of animals, germinal products and products of animal origin shall only be permitted to enter the Union if sampling, laboratory tests and other tests required by this Regulation have been carried out:(a)on samples taken by or under the control of the competent authority of:(i)the third country or territory of origin when sampling and testing are required prior to entry into the Union;or(ii)the Member State of destination when sampling and testing are required after the entry into the Union;(b)in accordance with:(i)the relevant procedures and methods set out in Delegated Regulation (EU) 2020/689 and Delegated Regulation (EU) 2020/688Commission Delegated Regulation (EU) 2020/688 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council, as regards animal health requirements for movements within the Union of terrestrial animals and hatching eggs (see page 140 of this Official Journal).;or(ii)for the purpose of entry into the Union of germinal products of bovine, porcine, ovine, caprine and equine animals, the procedures and methods set out in Annex II to Commission Delegated Regulation (EU) 2020/686Commission Delegated Regulation (EU) 2020/686 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards the approval of germinal product establishments and the traceability and animal health requirements for movements within the Union of germinal products of certain kept terrestrial animals (see page 1 of this Official Journal).;or(iii)the procedures described in this Regulation, where specifically required;(c)in an official laboratory, designated in accordance with Article 37 of Regulation (EU) 2017/625.Article 10Disease freedom of the place of origin and specific conditions1.Consignments of animals, germinal products and products of animal origin shall only be permitted to enter the Union if the freedom from particular diseases of the third country or territory of origin or zone thereof or of the establishment of origin of the animals, germinal products or products of animal origin, required by this Regulation has been demonstrated by the competent authority of the third country or territory of origin:(a)in accordance with Delegated Regulation (EU) 2020/689;or(b)for diseases not falling within the scope of Delegated Regulation (EU) 2020/689, in accordance with specific rules, where such rules are laid down in this Regulation, and the disease surveillance programme implemented by the third country or territory of origin, which must have been:(i)submitted to the Commission for assessment and contain at least the information referred to in Annex II;(ii)assessed by the Commission as providing the necessary guarantees as regards disease freedom based on:the rules on disease surveillance laid down in Articles 24, 25, 26 and 27 of Regulation (EU) 2016/429,the supplementing rules on surveillance design and the rules for disease confirmation and case definition laid down in Sections 1 and 2 and Article 10 of Chapter 1 of Part II of Delegated Regulation (EU) 2020/689;(iii)in place for a sufficient period of time for it to be fully implemented and properly supervised.2.In the case of aquaculture animals and products of animal origin from aquaculture animals, where disease freedom from particular diseases is required for the compartment of origin, consignments of those commodities shall only be permitted to enter the Union if the competent authority of the third country of origin has demonstrated disease freedom in accordance with paragraph 1(a) and (b).3.Where specific conditions related to the disease freedom from particular diseases of the third country or territory of origin, or zone thereof, are required in this Regulation:(a)the competent authority of the third country or territory of origin must have previously guaranteed its compliance;(b)those specific conditions shall have been specifically assigned by the Union in the list to the listed third country or territory, zone or compartment thereof and to the particular species and category of animals, germinal products and products of animal origin.