Eurlexa

Article 1Subject matter and scope1.This Regulation supplements Regulation (EU) 2017/625 as regards the requirements for the entry in the Union of consignments of food-producing animals and certain goods intended for human consumption from third countries or regions thereof in order to ensure that they comply with the applicable requirements established by the rules referred to in Article 1(2), point (a), of Regulation (EU) 2017/625 or with requirements recognised to be at least equivalent thereto.2.The requirements referred to in paragraph 1 cover:(a)the identification of food-producing animals and certain goods intended for human consumption subject to the following requirements for entry into the Union:(i)the requirement that those food-producing animals and certain goods intended for human consumption shall come from a third country or region thereof listed in accordance with Article 126(2), point (a), of Regulation (EU) 2017/625;(ii)the requirement that those food-producing animals and certain goods intended for human consumption be dispatched from, and obtained or prepared in, establishments which comply with applicable requirements referred to in Article 126(1) of Regulation (EU) 2017/625, or with requirements recognised to be at least equivalent thereto, and which appear on lists drawn up and updated in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625;(iii)the requirement that each consignment of food-producing animals and certain goods intended for human consumption be accompanied, by an official certificate, or official attestation or any other evidence of compliance with the rules referred to in Article 1(2), point (a), of Regulation (EU) 2017/625, such as a private attestation, in accordance with Article 126(2), point (c), of Regulation (EU) 2017/625;(b)requirements for the entry into the Union of food-producing animals and certain goods intended for human consumption from a third country or region thereof, listed in accordance with Article 127(2) of Regulation (EU) 2017/625;(c)requirements that consignments of food-producing animals and certain goods intended for human consumption from third countries be dispatched from, and obtained or prepared in, establishments which comply with the applicable requirements referred to in Article 126(1) of Regulation (EU) 2017/625, or with requirements recognised to be at least equivalent thereto, and which appear on lists drawn up and updated in accordance with Article 127(3), points (e)(ii)and (iii) of Regulation (EU) 2017/625;(d)requirements for the entry into the Union for placing on the market of the specific following commodities in addition to the requirements laid down in accordance with Article 126 of Regulation (EU) 2017/625:(i)fresh meat, minced meat, meat preparations, meat products, mechanically separated meat and raw materials intended for the production of gelatine and collagen;(ii)live bivalve molluscs, echinoderms, tunicates and marine gastropods;(iii)fishery products;(iv)composite products;(e)additional requirements for the official certificates, official attestations and private attestations that shall accompany food-producing animals and certain goods intended for human consumption for entry into the Union;(f)requirements for the use of pharmacologically active substances in food-producing animals and the residues thereof and for the levels of contaminants and pesticide residues in products of animal origin and composite products, where those food-producing animals, products of animal origin and composite products enter the Union from third countries and are intended to be placed on the market of the Union, and those requirements are necessary to ensure that such food-producing animals, products of animal origin and composite products provide a level of human health protection equivalent to that provided by the relevant Union rules on food safety;(g)the requirement that food-producing animals, products of animal origin and composite products shall only enter the Union from third countries that provide evidence and guarantees of compliance with the requirements set out in this Regulation by submitting a control plan.3.This Regulation shall not apply to:(a)animals and goods not intended for human consumption, however when the destination of the animals and goods has not been decided on entry into the Union and intention for human consumption cannot yet be excluded, this Regulation applies;(b)animals and goods intended for human consumption only for transit through the Union without being placed on the market;(c)goods intended for human consumption for the purpose of samples for product analysis and quality testing without being placed on the market.

Article 2DefinitionsFor the purposes of this Regulation, the following definitions shall apply:(1)"entering the Union" or "entry into the Union" means entering the Union or entry into the Union as defined in Article 3, point (40), of Regulation (EU) 2017/625;(2)"consignment" means consignment as defined in Article 3, point (37), of Regulation (EU) 2017/625;(3)"animals" means animals as defined in Article 3, point (9), of Regulation (EU) 2017/625;(4)"goods" means goods as defined in Article 3, point (11), of Regulation (EU) 2017/625;(5)"equivalent" means equivalent as defined in Article 2(1), point (e), of Regulation (EC) No 852/2004;(6)"establishment" means an establishment as defined in Article 2(1), point (c), of Regulation (EC) No 852/2004;(7)"official certificate" means official certificate as defined in Article 3, point (27), of Regulation (EU) 2017/625;(8)"official attestation" means official attestation as defined in Article 3, point (28), of Regulation (EU) 2017/625;(9)"private attestation" means an attestation signed by the food business operator entering goods into the Union;(10)"placing on the market" means placing on the market as defined in Article 3, point (8), of Regulation (EC) No 178/2002;(11)"fresh meat" means fresh meat as defined in point 1.10 of Annex I to Regulation (EC) No 853/2004;(12)"minced meat" means minced meat as defined in point 1.13 of Annex I to Regulation (EC) No 853/2004;(13)"meat preparations" means meat preparations as defined in point 1.15 of Annex I to Regulation (EC) No 853/2004;(14)"meat products" means meat products as defined in point 7.1 of Annex I to Regulation (EC) No 853/2004;(15)"mechanically separated meat" means mechanically separated meat as defined in point 1.14 of Annex I to Regulation (EC) No 853/2004;(16)"gelatine" means gelatine as defined in point 7.7 of Annex I to Regulation (EC) No 853/2004;(17)"collagen" means collagen as defined in point 7.8 of Annex I to Regulation (EC) No 853/2004;(18)"highly refined products of animal origin" means highly refined products referred to in Section XVI, point 1, of Annex III to Regulation (EC) No 853/2004;(19)"bivalve molluscs" means bivalve molluscs as defined in point 2.1 of Annex I to Regulation (EC) No 853/2004;(20)"fishery products" means fishery products as defined in point 3.1 of Annex I to Regulation (EC) No 853/2004;(21)"composite product" means food containing both products of plant origin and processed products of animal origin;(22)"pharmacologically active substance" means pharmacologically active substance as defined in Article 2, point (a), of Commission Delegated Regulation (EU) 2019/2090Commission Delegated Regulation (EU) 2019/2090 of 19 June 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and Council regarding cases of suspected or established non-compliance with Union rules applicable to the use or residues of pharmacologically active substances authorised in veterinary medicinal products or as feed additives or with Union rules applicable to the use or residues of prohibited or unauthorised pharmacologically active substances (OJ L 317, 9.12.2019, p. 28).;(23)"contaminant" means contaminant as defined in Article 1(1), second subparagraph, of Council Regulation (EEC) No 315/93Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food (OJ L 37, 13.2.1993, p. 1).;(24)"pesticide residues" means pesticide residues as defined in Article 3(2), point (c), of Regulation (EC) No 396/2005;(25)"product of animal origin" means product of animal origin as defined in point 8.1 of Annex I to Regulation (EC) No 853/2004;(26)"control plan for pharmacologically active substances, pesticides and contaminants" means a control plan on the use of pharmacologically active substances, the maximum residue limits of pharmacologically active substances, the maximum residue levels of pesticides and the maximum levels of contaminants in food-producing animals, products of animal origin, including those used in composite products;(27)"insects" means food consisting of, isolated from or produced from insects or their parts including any life stadia of insects intended for human consumption which are, when applicable, authorised in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the CouncilRegulation (EU) 2015/2283 of the European Parliament of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (OJ L 327, 11.12.2015, p. 1). and included in the Union list of novel foods established by Commission Implementing Regulation (EU) 2017/2470Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel food (OJ L 351, 30.12.2017, p. 72). ("the Union list of novel foods");(28)"transit" means transit as defined in Article 3, point (44), of Regulation (EU) 2017/625;(29)"reptile meat" means the edible parts, either unprocessed or processed, derived from farmed reptiles, belonging to the species Alligator mississippiensis, Crocodylus johnstoni, Crocodylus niloticus, Crocodylus porosus, Timon lepidus, Python reticulatus, Python molurus bivittatus or Pelodiscus sinensis, which are, when applicable, authorised in accordance with Regulation (EU) 2015/2283 and included in the Union list of novel foods;(30)"snails" means snails as defined in point 6.2 of Annex I to Regulation (EC) No 853/2004 and any other species of snails of the family of Helicidae, Hygromiidae or Sphincterochilidae, intended for human consumption;(31)"food" means food as defined in Article 2 of Regulation (EC) No 178/2002;(32)"feed" or "feedingstuff" means feed or feedingstuff as defined in Article 3, point (4), of Regulation (EC) No 178/2002;(33)"audit" means audit as defined in Article 3, point (30), of Regulation (EU) 2017/625;(34)"competent authorities" means competent authorities as defined in Article 3, point (3), of Regulation (EU) 2017/625;(34a)"honey" shall be understood as honey within the meaning of Council Directive 2001/110/ECCouncil Directive 2001/110/EC of 20 December 2001 relating to honey (OJ L 10, 12.1.2002, p. 47). including as regards the main types of honey;(34b)"apiculture products" means honey, beeswax, royal jelly, propolis or pollen, intended for human consumption;(35)"sprouts" means sprouts as defined in Article 2, point (a), of Commission Implementing Regulation (EU) No 208/2013Commission Implementing Regulation (EU) No 208/2013 of 11 March 2013 on traceability requirements for sprouts and seeds intended for the production of sprouts (OJ L 68, 12.3.2013, p. 16).;(36)"primary production" means primary production as defined in Article 3, point (17), of Regulation (EC) No 178/2002;(37)"slaughterhouse" means slaughterhouse as defined in point 1.16 of Annex I to Regulation (EC) No 853/2004;(38)"game-handling establishment" means game-handling establishment as defined in point 1.18 of Annex I to Regulation (EC) No 853/2004;(39)"cutting plant" means cutting plant as defined in point 1.17 of Annex I to Regulation (EC) No 853/2004;(40)"production area" means production area as defined in point 2.5 of Annex I to Regulation (EC) No 853/2004;(41)"factory vessel" means factory vessel as defined in point 3.2 of Annex I to Regulation (EC) No 853/2004;(42)"freezer vessel" means freezer vessel as defined in point 3.3 of Annex I to Regulation (EC) No 853/2004;(43)"reefer vessel" means a vessel equipped to store and transport palletised or loose cargo (bulk) goods in temperature-controlled holds or chambers;(44)"dairy products" means dairy products as defined in point 7.2 of Annex I to Regulation (EC) No 853/2004;(45)"egg products" means egg products as defined in point 7.3 of Annex I to Regulation (EC) No 853/2004;(46)"food business operator" means a food business operator as defined in Article 3, point (3), of Regulation (EC) No 178/2002.(47)"operator" means operator as defined in Article 3, point (29), of Regulation (EU) 2017/625;(48)"border control post" means border control post as defined in Article 3, point (38), of Regulation (EU) 2017/625.