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)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC ¹, and in particular Article 118(2) thereof,

Whereas:

• (1) Antimicrobial resistance is a major threat to public health. When resistance develops to an antimicrobial agent used to treat a specific infection for which there are no alternative treatments and that resistance spreads, it has serious and potentially life-threatening consequences for humans. Human health, animal health and the environment are interlinked. Therefore, one of the objectives of Regulation (EU) 2019/6 is to contain the spread of antimicrobial resistance with concrete measures to promote the prudent and responsible use of antimicrobial medicinal products in animals.

• (2) The use of antimicrobial medicinal products to promote growth or to increase yield is neither prudent nor responsible. An extensive body of scientific literature has shown that the use of antimicrobials for such purposes can trigger antimicrobial resistance. Therefore, by Regulation (EU) 2019/6, the use of antimicrobial medicinal products for the purpose of promoting growth or to increase yield is prohibited, which includes antimicrobials contained in veterinary medicinal products as well as antimicrobials contained in human medicinal products.

• (3) Moreover, Regulation (EU) 2019/6 provides for the procedure to designate certain antimicrobials to be reserved for the treatment of infections in humans. Such antimicrobials are not to be used in antimicrobial medicinal products administered to animals. That measure aims to preserve the efficacy of certain antimicrobials used to treat infections in humans, especially those considered treatments of last resort. Criteria for the designation of antimicrobials reserved for the treatment of certain infections in humans are laid down in Commission Delegated Regulation (EU) 2021/1760 ² and the list of antimicrobials reserved for treatment of certain infections in humans is set out in Commission Implementing Regulation (EU) 2022/1255 ³.

• (4) The international dimension of the development of antimicrobial resistance should also be considered. Specifically, Article 118(1) of Regulation (EU) 2019/6 provides that, in respect of animals or products of animal origin that are exported from third countries into the Union, operators in third countries are not to use antimicrobial medicinal products to promote growth or to increase yield, and are not to use the designated antimicrobials or groups of antimicrobials reserved for treatment of infections in humans.

• (5) Medicated feed is one of the routes for the oral administration of medicinal products to animals. Therefore, the prohibition of use of certain antimicrobial medicinal products in respect of animals or products of animal origin that are exported from third countries into the Union should also apply when such antimicrobial medicinal products are administered via medicated feed.

• (6) A robust system of controls regarding animals or products of animal origin that are exported from third countries into the Union is essential to ensure compliance with the requirements laid down in Regulation (EU) 2019/6. No specific system of controls on imports of animals or products of animal origin exists under the Union framework on veterinary medicinal products. The setting up of such dedicated framework of controls would have necessitated significant amount of resources and time. Moreover, it would have led to duplications at the level of the competent authorities and also on the operators concerned. For reasons of effectiveness and reduction of administrative burden, the existing Union framework on official controls is to be used to verify compliance of animals or products of animal origin entering the Union from third countries with Regulation (EU) 2019/6. To this effect, Regulation (EU) 2017/625 of the European Parliament and of the Council ⁴ has been amended by Regulation (EU) 2021/1756 ⁵. Therefore, the verification of compliance with the requirements set out in Article 118(1) of Regulation (EU) 2019/6 is to be done in accordance with Regulation (EU) 2017/625.

• (7) The consignments of animals or products of animal origin entering the Union that are subject to the prohibition on the use of antimicrobial medicinal products to promote growth or to increase yield and on the use of antimicrobials reserved for treatment of certain infections in humans should be clearly set out. Therefore, this Delegated Regulation should provide detailed rules on the prohibition laid down in Article 118(1) of Regulation (EU) 2019/6.

• (8) The vast majority of the consumption of antimicrobials in animals (in volume) relates to food-producing animals. In addition, there is increasing scientific evidence that the use of antimicrobials in food-producing animals has an impact on the development of antimicrobial resistance. Therefore, addressing antimicrobial resistance requires particular action on the use of antimicrobial medicinal products in food-producing animals or products of animal origin intended for human consumption. In accordance with the principle of proportionality, taking such action will contribute effectively to address the international dimension of the development of antimicrobial resistance while minimising the impacts on trade.

• (9) Moreover, it should be clarified that the prohibition of use of certain antimicrobials set out in Article 118(1) of Regulation (EU) 2019/6 concerns food-producing animals or products of animal origin intended for human consumption that are exported from third countries into the Union. To ensure legal certainty, the animals and products of animal origin concerned should be identified by means of references to the Combined Nomenclature codes set out in Council Regulation (EEC) No 2658/87 ⁶.

• (10) Consignments of animals or products concerned that are only intended for transit, as well as products concerned intended for the purpose of samples for product analysis and quality testing that are not placed on the market, should not be covered by this Regulation.

• (11) Consignments of the animals or products concerned that are exported from third countries into the Union should comply with the same restrictions that apply in the Union in relation to the objectives pursued by Articles 107(2) and 37(5) of Regulation (EU) 2019/6. To that effect, consignments of the animals or products concerned should only be allowed to enter the Union in the case that the third countries or regions thereof, from which those animals or products originate, can ensure compliance with the prohibition on the use of antimicrobial medicinal products for the purpose of promoting growth or to increase yield, and on the use of antimicrobials that have been reserved for the treatment of certain infections in humans.

• (12) Third countries -or regions- thereof that meet those requirements are to be included in a list that is to be drawn up by the Commission, by means of implementing acts, in accordance with Article 127 of Regulation (EU) 2017/625. Third countries or regions thereof are to be included on that list on the basis of available evidence and guarantees that the concerned animals or products originating in them comply with the Union’s prohibition on the use of antimicrobial medicinal products for the purpose of promoting growth or to increase yield, and on use of antimicrobials that have been reserved for the treatment of certain infections in humans.

• (13) Consignments of animals or products concerned entering the Union from third countries listed in accordance with Article 127 of Regulation (EU) 2017/625 should also be accompanied by an official certificate confirming compliance with the Union’s prohibition on the use of antimicrobial medicinal products for the purpose of promoting growth or to increase yield, and on use of antimicrobials that have been reserved for the treatment of certain infections in humans.

• (14) The Commission should adopt specific requirements on the official certificates required, by means of implementing acts, in accordance with Regulation (EU) 2017/625.

• (15) The conditions for entry into the Union of consignments of animals or products concerned will be known to third country operators as from the date of publication of this Regulation. However, the practical application of the framework laid down in this Regulation will necessitate the adoption of further implementing measures. For reasons of predictability and legal certainty and with a view to allow stakeholders concerned sufficient time to comply with the Union requirements, the conditions for the entry into the Union of consignments of animals or products set out in this Regulation should be deferred,

HAS ADOPTED THIS REGULATION:

Article 1

Subject matter and scope

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.

• (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

• (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.

Article 5

List of approved third countries

Article 6

Certification of compliance

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).

This Regulation shall be binding in its entirety and directly applicable in the Member States.

Done at Brussels, 27 February 2023.

For the Commission

The President

Ursula VON DER LEYEN