Commission Delegated Regulation (EU) 2023/905 of 27 February 2023 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council as regards the application of the prohibition of use of certain antimicrobial medicinal products in animals or products of animal origin exported from third countries into the Union (Text with EEA relevance)

• CELEX: Delegated Regulation (EU) 2023/905
• Articles: 8

Article 1 Subject matter and scope

1.   This Regulation lays down detailed rules on the application of the prohibition of use, in animals or products of animal origin that are exported from third countries into the Union, of antimicrobial medicinal products for growth promotion and yield increase, and antimicrobials reserved for treatment of certain infections in humans.

2.   This Regulation applies to live food-producing 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.

This Regulation also applies to products of animal origin intended for human consumption, 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 have been laid down under headings 3501, 3502 and 3504.

3.   This Regulation does not apply to the following:

(a)

gelatine and raw materials for the production thereof referred to in Section XIV, Chapter I, point 1, of Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council  ( 7 ) ;

(b)

collagen and raw materials for the production thereof referred to in Section XV, Chapter I, point 1, of Annex III to Regulation (EC) No 853/2004;

(c)

highly refined products referred to in Section XVI, Chapter I, point 1, of Annex III to Regulation (EC) No 853/2004;

(d)

wild animals and products derived therefrom;

(e)

insects, frogs, snails and reptiles, including products derived therefrom;

(f)

composite products;

(g)

animals or products of animal origin not intended for human consumption, unless the destination of the animals or products has not been decided at entry into the Union;

(h)

animals or products of animal origin intended for human consumption only for transit through the Union without being placed on the market;

(i)

products of animal origin intended for human consumption for the purpose of samples for product analysis and quality testing without being placed on the market.

Article 2 Definitions

For the purposes of this Regulation, the following definitions shall apply:

(1)

‘antimicrobial medicinal product’ means a medicinal product that contains or consists of one or more antimicrobials;

(2)

‘medicinal product’ means a medicinal product that is administered to animals, including when it is administered in medicated feed as defined in Article 3(2), point (a), of Regulation (EU) 2019/4 of the European Parliament and of the Council  ( 8 ) ;

(3)

‘food-producing animal’ means food producing animal as defined in Article 2, point (b), of Regulation (EC) No 470/2009 of the European Parliament and of the Council  ( 9 ) ;

(4)

‘consignment’ means consignment as defined in Article 3, point (37), of Regulation (EU) 2017/625;

(5)

‘transit’ means transit as defined in Article 3, point (44), of Regulation (EU) 2017/625.

Article 3 Restrictions on the use of certain antimicrobial medicinal products in animals or products derived therefrom entering the Union

Animals or products referred to in Article 1(2) that are exported from third countries into the Union shall not have been administered, or originate from animals that have been administered any of the following:

(a)

an antimicrobial medicinal product used for the purpose of promoting growth or to increase yield;

(b)

an antimicrobial medicinal product containing an antimicrobial that is included in the list of antimicrobials reserved for treatment of certain infections in humans laid down in Implementing Regulation (EU) 2022/1255.

Article 4 Conditions for the entry into the Union

1.   Consignments of the animals or products referred to in Article 1(2) shall only enter the Union where the following conditions are met:

(a)

they originate from a third country or region thereof included in the list of countries referred to in Article 5; and

(b)

they are accompanied by an official certificate referred to in Article 6 attesting that the consignment complies with the requirements in Article 3.

2.   By way of derogation from paragraph 1, point (a), consignments of the animals or products referred to in Article 1(2) may enter the Union from third countries that are not included in the list referred to in Article 5(1), where such third countries ensure that the consignments entering the Union originate from a Member State or from a third country included in the list.

Article 5 List of approved third countries

1.   The list referred to in Article 4(1), point (a), is to be established by means of an implementing act adopted by the Commission in accordance with Article 127 of Regulation (EU) 2017/625. If appropriate , that list may be combined with other lists developed under Article 127 of Regulation (EU) 2017/625.

2.   The Commission shall decide on the inclusion of third countries in the list in accordance with the requirements laid down in Article 127(3), points (a) to (d), and points (f) and (g), of Regulation (EU) 2017/625, on the basis of available evidence and guarantees that the requirements laid down in Article 3 are complied with, including information received on the procedures in place to guarantee the traceability and origin of animals or products referred to Article 1(2).

3.   In accordance with Article 127(4) of Regulation (EU) 2017/625, the Commission shall delete the reference to a third country or a region of a third country from the list if the conditions for inclusion in the list cease to be met.

Article 6 Certification of compliance

1.   Specific requirements on the official certificates referred in point (b) of Article 4(1) are to be laid down by the Commission, by means of implementing acts, in accordance with the examination procedure referred to in Article 126(3) of Regulation (EU) 2017/625.

2.   The official certificates may include details required in accordance with other Union legislation on public and animal health matters.

Article 7 Controls

Controls to verify compliance of consignments of the animals or products referred to in Article 1(2) with Article 3 shall be carried out in accordance with Regulation (EU) 2017/625.

Article 8 Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

The conditions for entry into the Union of consignments of animals or products set out in this delegated act shall apply as from 24 months after the date of application of the implementing act referred to in Article 6(1).