Food-producing animals and goods which are required to come from third countries or regions thereof that are included in the list referred to in Article 126(2), point (a), of Regulation (EU) 2017/625
Consignments of the following food-producing animals and goods intended for human consumption shall enter the Union only from a third country or region thereof included in the list for those animals and goods laid down in Implementing Regulation (EU) 2021/405:
(a)
live animals for which Combined Nomenclature codes (‘CN codes’) have been laid down in Part Two, Chapter 1, of Annex I to Regulation (EEC) No 2658/87, where those live animals are food-producing animals;
(b)
products of animal origin, including reptile meat and dead whole insects, parts of insects or processed insects, intended for human consumption, for which the following codes have been laid down in Part Two of Annex I to Regulation (EEC) No 2658/87:
(i)
CN codes in Chapters 2 to 5, 15, 16 or 29; or
(ii)
Harmonised System headings (‘HS headings’) 0901, 1702, 2105, 2106, 2301, 3001, 3002, 3302, 3501, 3502, 3503, 3504, 3507, 3913, 3926, 4101, 4102, 4103 or 9602;
(c)
live snails, other than sea snails, referred to by the CN code 0307 60 00 of Part Two of Annex I to Regulation (EEC) No 2658/87;
(d)
pollen flour falling under the CN code ex 1212 99 95 of Part Two of Annex I to Regulation (EEC) No 2658/87.
Additional requirements for the entry into the Union of food-producing animals and goods from a third country or region thereof
In addition to the requirements laid down in Article 127(3) of Regulation (EU) 2017/625, the Commission shall only decide on the inclusion of third countries or regions thereof in the list referred to in Article 126(2), point (a), of that Regulation if the following requirements are recognised by the Commission as being at least equivalent to the relevant requirements in the Union for the food-producing animals and goods referred to in Article 3 of this Regulation:
(a)
the legislation of the third country on:
(i)
the production of products of animal origin;
(ii)
the use of veterinary medicinal products, including rules on their prohibition or authorisation, their distribution, their placing on the market and the rules covering administration and inspection;
(iii)
the preparation and use of feed, including the procedures for using additives and the preparation and use of medicated feedingstuffs, as well as the hygiene quality of the raw materials used for preparing feedingstuffs and of the final product;
(b)
the hygiene conditions of production, manufacture, handling, storage and dispatch currently applied to products of animal origin destined for the Union;
(c)
any experience of marketing of the products of animal origin from the third country and the results of any official controls on entry in the Union;
(d)
when available, the results of audits carried out by the Commission in the third country related to other food-producing animals and goods for which the third country is already listed in accordance with Article 127(2) of Regulation (EU) 2017/625, in particular the results of the assessment of the competent authorities in the third country audited, and the action that the competent authorities have taken in the light of any recommendations addressed to them following such audits by the Commission;
(e)
the existence, implementation and communication of a zoonoses control programme approved by the Commission when applicable;
(f)
the third country’s requirements as regards pharmacologically active substances, pesticides and contaminants, in accordance with Article 6.
Animals and products to which Articles 6 to 12 apply
1. The requirements laid down in Articles 6 to 12 shall apply to the following animals and products:
(a)
live animals for which CN codes have been laid down in Part Two, Section 1, Chapter 1, of Annex I to Regulation (EEC) No 2658/87, where those animals are food-producing animals;
(b)
products of animal origin, for which CN codes have been laid down in Part Two, Chapters 2 to 5, 15 and 16 of Annex I to Regulation (EEC) No 2658/87, and for which Harmonised System subheadings (‘HS subheadings’) have been laid down under HS headings 0901, 2105, 3501, 3502 and 3504;
(c)
composite products for which CN codes have been laid down in Part Two, Section III, Chapter 15, and Section IV, Chapters 16 to 22, of Annex I to Regulation (EEC) No 2658/87.
2. The requirements laid down in Articles 6 to 12 shall not apply to
—
gelatine and to raw materials for the production of gelatine, referred to in Section XIV, Chapter I, point 1, of Annex III to Regulation (EC) No 853/2004, and
—
collagen and to raw materials for the production of collagen, referred to in Section XV, Chapter I, point 1, of Annex III to that Regulation, and
—
highly refined products of animal origin, and
—
insects, frogs, frogs’ legs, snails, reptiles and reptile meat.
Additional requirements for the entry into the Union of food-producing animals, products of animal origin and composite products, as regards pharmacologically active substances and residues thereof, contaminants and pesticide residues
1. In addition to the requirements laid down in Regulation (EU) 2017/625, consignments of food-producing animals, products of animal origin and composite products shall enter the Union only from a third country that has in place a control plan for pharmacologically active substances, pesticides and contaminants setting out guarantees as regards compliance with:
(a)
the Union requirements on the use of pharmacologically active substances, the maximum residue limits of pharmacologically active substances, maximum residue levels of pesticides and maximum levels of contaminants; and
(b)
the additional requirements specified in Articles 9 to 12 of this Regulation.
2. In addition to the requirements laid down in Article 127(3) of Regulation (EU) 2017/625, the Commission shall decide on the inclusion of a third country in the list referred to in Article 126(2), point (a), of that Regulation only if that third country provides evidence and guarantees of compliance with the requirements laid down in paragraph 1 of this Article, together with the information listed in Part II of Annex I to this Regulation, in the request for inclusion in the list of third countries which that third country is to submit under Article 127(2) of Regulation (EU) 2017/625.
3. After having approved the inclusion of the third country in the list of authorised third countries, the Commission shall ensure, in accordance with Article 127(3) of Regulation (EU) 2017/625, that the third country continues to comply with the requirements laid down in paragraph 1 of this Article.
4. For the purposes of paragraph 3, the Commission shall take into account the updated evidence and guarantees of compliance with the requirements laid down in paragraph 1, including the required information on the third country’s control plan for pharmacologically active substances, pesticides and contaminants in accordance with Part II of Annex I, to be submitted by that third country by 31 March of each year.
Inclusion of a third country in a list of third countries that comply with Union requirements on pharmacologically active substances and residues thereof, contaminants and pesticide residues
In addition to the conditions laid down in Regulation (EU) 2017/625, consignments of food-producing animals, products of animal origin and composite products, shall enter the Union only from a third country that complies with the requirements provided for in Article 6(1) and is included in the list of third countries approved for the entry into the Union of the concerned food-producing animals or products of animal origin, set out in Annex -I to Implementing Regulation (EU) 2021/405.
Derogation from the requirements for the entry into the Union of food-producing animals, products of animal origin and composite products
1. By way of derogation from Article 7, consignments of food-producing animals, products of animal origin and composite products may enter the Union from third countries that do not have an approved control plan for pharmacologically active substances, pesticides and contaminants but ensure that the food-producing animals and products of animal origin, including those used in composite products, originate in a Member State or a third country included in the list set out in Annex -I to Implementing Regulation (EU) 2021/405 as regards those food-producing animals or products of animal origin.
2. In addition to the requirements laid down in Article 127(3) of Regulation (EU) 2017/625, the Commission shall decide on the inclusion of a third country in the list referred to in Article 126(2), point (a), of that Regulation only if the competent authority of that third country provides the Commission with evidence and guarantees of compliance with the requirements laid down in paragraph 1 of this Article. Such evidence and guarantees shall consist of information on the procedures in place in that third country to guarantee the traceability and origin of those food-producing animals and those products of animal origin.
3. Where a third country is included, in accordance with paragraphs (1) and (2), in the list of authorised third countries for specific food-producing animals or products of animal origin, the entry for that third country shall be accompanied by the following note:
‘Third country, only entering the Union specific food-producing animals or products of animal origin – as such or as ingredients of composite products –, which originate (a) from other third countries authorised for the entry into the Union of such food-producing animals or products of animal origin; or (b) from Member States, in accordance with Article 8 of Commission Delegated Regulation (EU) 2022/2292.’.
For third countries that, because of animal health requirements, may not enter the Union specific food-producing animals or products of animal origin as such, the entry for that third country shall be accompanied by the following note:
‘Third country, only entering the Union composite products containing processed products of animal origin, which originate (a) from other third countries authorised for the entry into the Union of such products of animal origin; or (b) from Member States, in accordance with Article 8 of Commission Delegated Regulation (EU) 2022/2292.’.
4. For the production of casings intended for entry into the Union, third countries may use raw materials of animal origin sourced from Member States or from other third countries or regions thereof which are authorised for the entry into the Union of fresh meat, or of certain meat products and treated stomachs, bladders and intestines, and which are listed in the relevant lists of such fresh meat and meat products of Commission Implementing Regulation (EU) 2021/404 ( 30 ) or Implementing Regulation (EU) 2021/405. Third countries entering the Union casings shall be listed in Annex -I to Implementing Regulation (EU) 2021/405 for casings. In addition, the establishments from which the casings are to be entered the Union shall be listed in accordance with Article 13(1) of this Regulation.
5. After having approved the inclusion of the third country in the lists of authorised third countries referred to in this Article, the Commission shall ensure, in accordance with Article 127(4) of Regulation (EU) 2017/625, that the third country continues to comply with the requirements laid down in paragraph 1 of this Article.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
