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

Live animals and certain animal products exported to the EU will be subject to stricter rules ensuring that they are not produced using certain prohibited antimicrobials. Compliant countries will have to be included on a list of authorised exporting countries, and use official certificates including an attestation of compliance signed by authorities in non-EU countries. This Regulation establishes the legal basis for these stricter requirements. Non-EU countries must send a written declaration providing guarantees of conformity with these requirements before November 2023. The new requirements will not apply until the EU adopts further measures detailing the list ofapproved countries and the new model official certificates.

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 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. Based on 2019/6, Art. 118, both will apply to animal products exported from non-EU countries through the following new rules:

• Non-EU countries must show evidence of compliance with the prohibition. Compliant countries will be placed on a list of authorised exporting countries.
• Non-EU authorities must confirm compliance by signing a new specific attestation. This must be added to the official certificates that accompany exported goods.

This Regulation establishes the basic principles. The EU will also adopt further measures detailing:

• the revised Model health certificates, and
• the list of countries.

Non-EU countries received a letter in May 2023, requesting them to produce a written declaration providing guarantees of conformity with Article 3 of Regulation 2023/905 before November 2023. The EU Commission will assess the guarantees, and draft an Implementing Act with the list of non-EU countries that have provided guarantees.

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

Why?

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

Timeline

Date of publication: 4 May 2023.

The EU will adopt further measures detailing the list of countries and the revised Model health certificates. The new requirements will apply 24 months after these further measures are applicable.

What are the major implications for exporting countries?

Non-EU countries exporting livestock and animal products to the EU will have to put in place a system guaranteeing that prohibited antimicrobials are not used in goods exported to the EU market. This will be a condition for inclusion on the dedicated list of authorised exporting countries.

If non-EU countries fail to provide the declaration guaranteeing compliance with rules on antimicrobials prior to November 2023, they risk not being included in the list, in which case they will no longer be able to export animal products.

When Regulation 2023/905 enters into application, non-EU country authorities will need to certify each consignment of animal products exported to the EU.

Recommended Actions

Competent authorities in exporting countries should ensure that the declaration requested by the Commission is submitted by November 2023.

They should assess their own situation, and the measures needed to be in compliance with Regulation 2023/905. They should meet with representatives of the livestock and animal products sector to put in place the mechanisms needed to provide guarantees of compliance, and to ensure awareness and preparation. They might also need to develop some national legislation, or adapt their control systems accordingly.

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.

In addition, the draft Implementing Regulation adapting the official certificates has been notified to the World Trade Organization. Comments or concerns about potential impacts can be submitted, via the National SPS notification authority of the country concerned, to the EU SPS Enquiry Point until 16 September 2023.

Background

To fight antimicrobial resistance and establish its global dimension, 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).

Sources

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