Draft Commission Implementing Regulation 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, and Annex

Update

The EU is amending the public health attestations of model official certificates for entry into the EU of animals or animal products exported from non-EU countries. This change reflects the prohibition of certain antimicrobial medicinal products in these animals and products.

Impacted Products

Livestock, 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?

The attestations in the Annex of the draft Regulation will be included in the model health certificates as shown in Table 1.

The attestations confirm compliance 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.

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

World Trade Organization (WTO) consultation: until 16 September 2023.

Expected date of adoption: October 2023.

Expected date of publication: January 2024.

Expected date of application: August 2024.

What are the major implications for exporting countries?

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

In parallel with the new attestation, a future implementing Regulation will draw up the list of third 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 Article 3 of Regulation 2023/905 before November 2023.

The European Commission will assess the guarantees, and draft the Implementing Act with the list of non-EU countries that have provided guarantees.

If non-EU countries fail to provide that declaration, they risk not being included in the list, in which case they will no longer be able to export animal products.

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.

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

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 to promote growth or to 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).

Sources

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