Rules on prohibited antimicrobials in imported animal products

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

Update

Regulation 2023/905 applies restrictions on the use of antimicrobials to live animals and animal products imported into the EU. It bans the use of antimicrobials as growth promoters or to increase yield, and the use of certain antimicrobials reserved for human treatments. This extends the restrictions that apply to animals reared in the EU to include imported live animals and animal products.

In order to export such products to the EU, countries will have to be included in the official list of authorised exporting countries (confirming they are compliant with the new antimicrobial rules) by 3 September 2026, and must use the updated official certificates that have an attestation of compliance signed by their competent authorities.

Impacted Products

Livestock and animal products for human consumption.

Exceptions are:

- gelatine, collagen, highly refined products, composite products, wild animals, insects, frogs, snails, and reptiles

- animals and food in transit not placed on the EU market

- animals or animal products not intended for human consumption

- samples for product analysis and quality testing not placed on the market.

What is changing?

Under Regulation 2022/1255, certain antimicrobials are reserved for human treatment in the EU (and thus are prohibited from being used in food-producing animals), and Regulation 2019/6 (Art. 107) bans the use of antimicrobials for growth promotion in the EU. Non-EU countries (2019/6, Art. 118) must:

• show evidence of compliance with the prohibition on antimicrobials; compliant countries will be placed on the list of authorised exporting countries
• confirm compliance by signing a new specific attestation for each consignment, which must be added to the official certificates already required for animal product exports.

Regulation 2023/905 extends these rules to animals or products of animal origin imported into the EU. The EU is reinforcing these rules by establishing a list of authorised countries that have demonstrated that they meet EU requirements, and providing revised Model health certificates that include a specific attestation on antimicrobials.

The new rules will not apply to products in transit in the EU, or to gelatine, collagen, highly refined products, composite products, wild animals, insects, frogs, snails, or reptiles.

Why?

Antimicrobial (antibiotic) resistance is viewed as a major threat to global health. The EU seeks to ensure prudent and responsible use of antimicrobials in animals. It prohibits the use in animals of certain antimicrobials that are used to treat humans, to ensure their continued effectiveness. Antimicrobials cannot be used either as growth promoters or to increase yield.

Timeline

The new rules apply from 3 September 2026 (24 months after Regulation 2024/399 laying down the revised Model health certificates enters into application).

What are the major implications for exporting countries?

Only countries that can guarantee exported animal products meet the EU’s antimicrobial requirements will be able to continue exporting animal products to the EU. From 3 September 2026, non-EU country authorities will need to be on the list of authorised exporting countries and must certify each consignment of animal products exported to the EU.

Recommended Actions

Non-EU countries exporting livestock and animal products to the EU will have to put in place a system that can guarantee prohibited antimicrobials are not used in goods exported to the EU market during the whole lifetime of the animals.

Particular attention must be paid to products that have a long cycle of production (beef, casings, processed products, etc.). To be able to export such products to the EU from 3 September 2026, the guarantees must be in place from the birth of the food-producing animals, which may mean, for example, a period of 2 years or more prior to export.

In each country, competent authorities will have to assess what steps are required to comply with Regulation 2023/905. Coordination with representatives of the livestock and animal products sector will be needed, and potentially the adoption of national legislation or adaptation of control systems.

A forthcoming draft Implementing Regulation listing authorised non-EU countries will be notified to the World Trade Organization. In the meantime, any questions can be emailed to agrinfo@colead.link.

Background

To fight antimicrobial resistance and combat its global spread, Regulation 2019/6, Art. 118(1) established that the following provisions are also to be applied to operators from non-EU countries exporting animals and certain animal products for human consumption to the European Union:

• the prohibition of using antimicrobials to promote growth and increase yield
• the prohibition of using antimicrobials reserved for the treatment of specific infections in humans, as listed in the Annex of Implementing Regulation 2022/1255 (see List of antimicrobials reserved for treatment of certain infections in humans); the criteria for which antimicrobials are reserved for human use are established in Regulation (EU) 2021/1760.

The list of non-EU countries, and the adaptation of the official certificates, will be based on the Official Controls Regulation 2017/625 (Arts. 126 and 127).

Resources

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