Model health certificates: antimicrobial attestation
- Animal health
- Animal health certification
- Antimicrobial resistance
Summary
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. For fishery products, the model certificates were revised in July 2024.
The new model certificates for live animals and their products must be used from 3 September 2024 (except those for fishery products, which must be used from 30 January 2025).
In addition, as soon as possible, competent authorities in exporting countries must provide an “antimicrobials declaration” for every animal product they export to the EU.
EU model health certificates for animal products adapted to cover antimicrobials
Commission Implementing Regulation (EU) 2024/2020 of 26 July 2024 amending and correcting Annex III to Implementing Regulation (EU) 2020/2235 as regards model certificates for the entry into the Union of consignments of certain categories of animals and certain products of animal origin intended for human consumption, and correcting Implementing Regulation (EU) 2024/399
Commission Implementing Regulation (EU) 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. For fishery products, the model certificates were revised in July 2024.
The new model certificates for live animals and their products must be used from 3 September 2024 (except those for fishery products, which must be used from 30 January 2025).
In addition, as soon as possible, competent authorities in exporting countries must provide an “antimicrobials declaration” for every animal product they export to the EU.
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)
Regulation 2024/2020 (Annex) amends the model certificates related to fishery products: Chapter 29 (model EU-FISH), Chapter 30 (model FISH/MOL-CAP), and Chapter 31 (model MOL-HC). The revised attestations can be found in the Annex to the Regulation.
Why?
The official certificates with attestations signed by non-EU country authorities guarantee that only food produced in compliance with the EU legislation is exported to the EU.
Timeline
Competent authorities and operators must use the new model certificates for live animals and their products 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.
For fishery products, the new model certificates must be used from 30 January 2025. Products with a certificate issued before 30 January (using the model in the Annex to the earlier Regulation 2024/399) will be able to enter the EU until 30 April 2025.
Although the new model certificates must be used from September 2024, the new rules requiring competent authorities in non-EU countries to sign public health attestations relating to antimicrobials will only apply from 3 September 2026 (when Regulation 2023/905 enters into force). Between 3 September 2024 and 2 September 2026, the attestation related to antimicrobials will not yet apply, and it must be crossed out (European Commission 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?
For details on implications of new rules concerning the use of certain antimicrobials in live animals and their products that are exported to the EU, see Rules on prohibited antimicrobials in imported animal products). Competent authorities in exporting countries may need to develop national legislation or adapt their control systems so that they can guarantee compliance.
Recommended Actions
Competent authorities and operators in exporting countries should ensure they use the correct model of the official certificate from 3 September 2024 (for fishery products, from 30 January 2025).
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
Regulation 2023/905 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
Regulation 2019/6 on veterinary medicinal products
European Commission (2019) Regulation (EU) 2019/6 – Delegated Acts – see “Detailed rules regarding animals or products of animal origin imported into the Union [Article 118(2)]”.
European Commission (2024) State of play concerning the implementation of Commission Delegated Regulation (EU) 2023/905, Presentation, Meeting between the European Commission and non-EU Countries, 6 March.
Sources
Commission Implementing Regulation (EU) 2024/2020 as regards model certificates for the entry into the Union of consignments of certain categories of animals and certain products of animal origin intended for human consumption
Commission Implementing Regulation (EU) 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
Tables & Figures
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EU model health certificates for animal products adapted to cover antimicrobials
Regulation
Implementing Regulation 2024/2020 as regards model certificates for the entry into the Union of consignments of certain categories of animals and certain products of animal origin intended for human consumption
Implementing 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.)
The EU is therefore changing the model official certificate sent with exports of food-producing animals and their products so that they are aligned. 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, except those for fishery products, which must be used from 30 January 2025.
Timeline
The new model certificates must be used 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.
For fishery products, the model certificates were revised in July 2024. The new model certificates for fishery products must be used from 30 January 2025. Fishery products with a certificate issued before 30 January will be able to enter the EU until 30 April 2025.
The new rules requiring official authorities in non-EU countries to sign attestations regarding antimicrobials will only apply from 3 September 2026 (when Regulation 2023/905 enters into force). Because the attestation regarding antimicrobials will not apply before that date, it must be crossed out. If using the EU’s Trade Control and Expert System (TRACES), this will be done automatically.
Tables & Figures
Disclaimer: Under no circumstances shall COLEAD be liable for any loss, damage, liability or expense incurred or suffered that is claimed to have resulted from the use of information available on this website or any link to external sites. The use of the website is at the user’s sole risk and responsibility. This information platform was created and maintained with the financial support of the European Union. Its contents do not, however, reflect the views of the European Union.