Summary
•The Animal Health Regulation (AHR) takes effect in the EU from 21 April 2021. The AHR introduces new Export Health Certificates for germinal products, however transitional provisions in the legislation mean that these do not need to be introduced immediately.
•Exports of germinal products from Great Britain will continue to use existing EU EHCs for products intended to be certified before 21 August 2021. You can find the existing EHCs on gov.uk.
•The European Commission have indicated that they will roll over the current lists of approved germinal product collection and storage centres from the 21 April. Establishments shall continue to use same approval numbers. See here.
•Establishments seeking new or amended approvals for exports of germinal products to the EU, shall be assessed in line with the new AHR requirements from 21 April.
•The UK has been listed for the export of Germinal Products under the Animal Health Regulation.
•The new Model AHR EHCs can be found in Annex II to Regulation 2021/403.These will be made available on EHC Online and Form Finder for familiarisation later in the year.
•Where products are being collected after 21 April, in anticipation of export from 21 August, there are certain steps that you may wish to take now to prepare to meet the requirements of the new EHCs.
Background
The UK will exercise the transitional provisions provided in Article 27 to Regulation (EU) 2021/403. This means that GB exporters can continue to use the existing EU Model EHCs until 20 August 2021.
The existing export requirements are contained in the relevant EU Decisions or Regulations. For example, Regulation 2018/659 (Equine Germinal Products), Decision 2010/472 (Ovine/caprine Germinal products) and Decision 2011/630 (Bovine semen).
For exports from 21 August, new AHR EHCs are required, and Defra will publish the new AHR EHCs and accompanying Notes for Guidance on gov.uk by the end of July.
With respect to the new AHR third country listing, the relevant EU regulations are 2021/404 and 2021/405. These regulations have been amended by Regulations 2021/634 and 2021/606, adding the Great Britain and the Crown Dependencies to the relevant lists.
Establishment approvals and identification of straws
The Commission have indicated that the germinal product establishment lists will be rolled over from the 21 April and such listed establishments can continue to export to the Union from 21 April.
The lists of EU approved collection and storage centres for your commodity can be found here.
Defra and APHA will provide further advice in due course for establishments seeking approval for different categories (e.g. processing or sorting multi species/types of germinal products).
New establishments seeking approval for after 21 April will be assessed in accordance with new AHR requirements.
Requests for amended approvals or new approvals should be sent to APHA CIT.
The AHR introduces a requirement for germinal product exports to be marked with a unique approval number, including the ISO code of the country of origin. The Commission has though indicated their intention to amend the relevant regulation to remove the ISO code requirement (article 83 to Regulation 2020/692). Defra advise that the unique approval numbers of establishments can continue to use the ‘UK’ prefix labelled on the straws as per approval numbers listed on the EU website.
Criteria for germinal products collected between 21 April – 20 August and exported from 21 August 2021.
Defra are seeking clarity from the European Commission on the specific requirements for products collected after 21 April, that will be frozen and exported using the new AHR Export Health Certificate following 20 August. To mitigate against any risk of these consignments not complying with the requirements of the AHR Export Health Certificate, you may wish to perform the following:
•begin to test new donor animals in line with the AHR requirements, outlined below, from 21 April;
•ensure that donor animals are identified with a GB ISO code, as opposed to UK, identifier for products collected from 21 April and exported after 20 August, in accordance with requirements in Article 21 to Regulation 2020/692. Defra are seeking confirmation from the Commission on whether this should apply from 21 August or if the requirement will be lifted in line with the proposal to amend Article 83 to Regulation 2020/692 concerning marking of straws. Further advice will be sent out as soon as possible.
Further advice on testing and identification can be sought from APHA. Defra will issue further guidance in due course.
Summary of main changes for export of germinal products under Animal Health Regulation EHCs used from 21 August 2021.
It is important to note that the AHR establishment approval and export requirements are similar to existing requirements for export to the Union. Export requirements of germinal products from 21 August are summarised in Regulations (EU) 2020/692 and 2020/686.
Here is a summary of the main changes relevant for exports from 21 August:
•There is a new category of approval of establishments, called Germinal Product Processing establishment. This means an establishment approved for processing (i.e. sex sorting) and storage of multiple types of germinal products from multiple species.
•The approved storage centres may store multi-species and types of germinal products.
•The new AHR is more prescriptive for brucella testing and requires testing for Brucella abortus, Brucella melitensis and Brucella suis.
•For donor boars, Porcine Reproductive Respiratory Syndrome (PRRS) testing will be required for first and second series testing as well as routine testing. A PCR test is required for PRRS at second series in addition to serological test. Serological test is only required for first series and routine testing on semen collection centre. Serological test (IPMA, IFA or ELISA) and PCR test must be performed at Weybridge laboratory. Classical Swine Fever (CSF) testing must be included as part of the second series of tests too.
•Identification of straws must include the species of the donor animal.
•There are new rules on movements of mixed or pooled semen of bovine, porcine, ovine and caprine animals, provided that mixing of semen is restricted only to one semen collection centre where the semen was collected and a mark on each straw or other package in which mixed semen is placed allows tracing the individual identification numbers of all donor animals. This information can be found in recital 29 to Regulation 2020/686.
•The transport of germinal products of different types of a single species in one container is permitted under certain conditions.
•There are new requirements for tuberculosis testing/surveillance in donor bucks at semen collection centres; donor bovine animals for embryos/oocytes have to originate from tuberculosis (and brucellosis and Enzootic Bovine Leukosis) free holdings and to never been kept on holdings of a lower health status.