Model health certificates: antimicrobial attestation

Commission Implementing Regulation 2024/399 of 29 January 2024 amending Annex III to Implementing Regulation (EU) 2020/2235 and Annex II to Implementing Regulation (EU) 2021/403 as regards model certificates for the entry into the Union of consignments of certain products of animal origin and certain categories of animals

Update

From 2026, the EU will prohibit the use of certain antimicrobials in live animals and their products that are exported to the EU. The model official certificates for entry into the EU are being amended so that this prohibition is reflected in the public health attestation that must be made by the competent authorities in exporting countries. The new model certificates must be in use from 3 September 2024. In addition, competent authorities in exporting countries must provide an “antimicrobials declaration” for every animal product they export to the EU as soon as possible.

Impacted Products

Livestock, animal products for human consumption (eggs, casings, milk/dairy, honey, aquaculture, etc.)

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?

Delegated Regulation 2023/905 requires that from September 2026, consignments of relevant animals or animal products entering the EU from non-EU countries must be accompanied by an official certificate attesting compliance with the EU's prohibition on the use of antimicrobial medicinal products.

The attestation in the certificate declares that products were produced from animals that have not been administered antimicrobial medicinal products:

• for growth promotion, or
• for yield increase, or
• included in the list of antimicrobials reserved for the treatment of certain infections in humans.

The Annex to Regulation 2024/399 provides the wording of the attestation that must be included in the certificate for each category of animal products (amending Annex III of Regulation 2020/2235), and for each category of live terrestrial animals (amending Annex II of Regulation 2021/403).

For example, the attestation for beef reads:

I, the undersigned official veterinarian declare that, I am aware of the relevant requirements of Regulation (EU) 2019/6 of the European Parliament and of the Council and Commission Delegated Regulation (EU) 2023/905 and hereby certify that fresh meat of domestic bovine animals (including Bison and Bubalus species and their cross-breeds) described in Part I was produced in accordance with these requirements, and in particular, that the animals from which the meat is derived have not been administered antimicrobial medicinal products for growth promotion or yield increase or antimicrobial medicinal products containing an antimicrobial that is included in the list of antimicrobials reserved for the treatment of certain infections in humans laid down in Commission Implementing Regulation (EU) 2022/1255 as set out in Article 3 of Delegated Regulation (EU) 2023/905 and originate from a third country or region thereof listed in accordance with Article 5(2) of Delegated Regulation (EU) 2023/905.

(Source: Regulation 2024/399)

Why?

The official certificates (containing the attestations) signed by non-EU country authorities guarantee that only food produced in compliance with the EU legislation is exported to the EU.

Timeline

Date of publication: 12 February 2024.

Competent authorities and operators must use the new model certificates from 3 September 2024. Products with a certificate issued before 3 September (using the model valid before 3 September) will be able to enter the EU until 3 December 2024.

Although the new model certificates must be used from September 2024, the new rules requiring official authorities in non-EU countries to sign attestations relating to antimicrobials will only apply from 3 September 2026 (when Regulation 2023/905 enters into application). Between 3 September 2024 and 2 September 2026, because the attestation related to antimicrobials will not yet apply, it must be crossed out (as clarified by the Commission during an online meeting with non-EU countries on 6 March 2024). If using the EU’s Trade Control and Expert System (TRACES), this will be done automatically.

What are the major implications for exporting countries?

Competent authorities in exporting countries may need to develop national legislation or adapt their control systems so that they can guarantee compliance by signing the attestation in the official certificate.

For non-EU countries that do not prohibit antimicrobials targeted by EU rules, systems must be rapidly put into place to segregate animals that have been treated with antimicrobials or those destined for the EU market. The prohibition applies to the whole life of food-producing animals. Even if treatment occurs only once, the products from that animal cannot be exported to the EU after 3 September 2026. Action is particularly urgent regarding animals with a long life cycle that have already been born (such as cattle or farmed fish), or products with a long shelf life (processed products such as dairy, casings, canned food, etc.).

In parallel with the new attestation, a future Implementing Regulation will draw up the list of non-EU countries authorised to continue exporting animal products to the EU with regard to antimicrobials (see Rules on prohibited antimicrobials in imported animal products). Non-EU countries received a letter in May 2023 requesting them to produce a written declaration providing guarantees of conformity with Art. 3 of Regulation 2023/905 before November 2023. The European Commission will assess these guarantees, and the countries providing guarantees will be listed in the draft Implementing Act.

Any non-EU country that fails to provide this declaration risks not being included in the list, in which case they will no longer be able to export animal products to the EU. Non-EU countries that have not already done so should send their declaration to the Commission as soon as possible. The declaration must cover every animal product exported to the EU.

Recommended Actions

Competent authorities and operators in exporting countries should ensure they use the correct model of the official certificate from 3 September 2024.

They should evaluate what legal or practical measures (such as segregation of food-producing animals intended to be exported to the EU) are required to be in compliance with Regulation 2023/905 by 3 September 2026, when it will enter into application. Urgent action may be needed in relation to food products with a longer life cycle.

Competent authorities should also ensure they have sent to the Commission the “antimicrobials declaration” for every animal product they export to the EU (including for honey, casings, aquaculture, etc.), so that they will be listed for each of them. Although the November 2023 deadline has passed, if not yet done, it is recommended to send the declaration as soon as possible to prevent any disruption of trade in September 2026 (see Rules on prohibited antimicrobials in imported animal products). The declaration should be sent to SANTE-VETERINARY-MEDICINES@ec.europa.eu.

Background

Regulation 2019/6 (Art. 118(1)) requires non-EU country operators exporting animals or animal products to the EU to respect the prohibition on the use of antimicrobial medicinal products that promote growth or increase yield, and on the use of antimicrobials reserved for the treatment of certain infections in humans.

According to Delegated Regulation 2023/905 (Art. 4(1)(b)), consignments of relevant animals or animal products entering the EU from non-EU countries should be accompanied by an official certificate attesting compliance with the EU's prohibition on the use of antimicrobial medicinal products. The existing model certificates are amended to include the relevant attestations of compliance according to Regulation (EU) 2019/6 (see Rules on prohibited antimicrobials in imported animal products).

Resources

Sources

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Regulation

Regulation 2024/399 as regards model certificates for the entry into the Union of consignments of certain products of animal origin and certain categories of animals

What is changing and why?

From 2026 the EU will ban the use of certain medicines (antimicrobials) in live animals and their products that are exported to the EU. (See Rules on prohibited antimicrobials in imported animal products for information on the application of Regulation 2023/905.)

This means that the EU is changing the model official certificate sent with exports of food-producing animals and their products. The new model certificates include an attestation, signed by authorities in non-EU countries, guaranteeing that exported products are from animals that have not received antimicrobial medicines that promote growth or increase yields, or that are only for use in humans.

Actions

Competent authorities and operators in countries exporting animals and animal products to the EU should ensure that the correct model of the official certificate is used from 3 September 2024.

For non-EU countries that do not prohibit antimicrobials targeted by EU rules, systems must be rapidly put into place to be able to segregate animals that have been treated with antimicrobials or those destined for the EU market, in particular in relation to food products with a longer life cycle. The prohibition applies to the whole life of food-producing animals.

Also, non-EU exporting countries that have not already done so must send to the Commission an “antimicrobials declaration” for every animal product they export to the EU (including for honey, casings, aquaculture, etc.) so that they will be listed for each one. This may require coordination between several departments (see Rules on prohibited antimicrobials in imported animal products). Although the November 2023 deadline has passed, it is important to catch up as soon as possible by sending declarations to SANTE-VETERINARY-MEDICINES@ec.europa.eu.

Timeline

The new model certificates must be in use from 3 September 2024. Products with a certificate issued before 3 September (using the model valid before 3 September) will be able to enter the EU until 3 December 2024.

Although the new model certificates must be used from September 2024, the new rules requiring official authorities in non-EU countries to sign attestations relating to antimicrobials will only apply from 3 September 2026 (when Regulation 2023/905 enters into application). Between 3 September 2024 and 2 September 2026, because the attestation related to antimicrobials will not yet apply, it must be crossed out. If using the EU’s Trade Control and Expert System (TRACES), this will be done automatically.

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