Breeding companies, farmers, and hobby breeders use animals and animal reproductive material in their breeding programmes, with the animals and material sometimes introduced from abroad. When are their activities in scope of the EU ABS Regulation? We take a closer look at ABS legislation on animal breeding in the EU.
When determining whether animal breeding activities are subject to access and benefit-sharing rules, it is important to assess if the breeding activities are in scope of the EU ABS Regulation (Regulation (EU) 511/2014). The revised EU Guidance document helps to answer these questions for animal breeding by providing additional information on the scope of the EU ABS Regulation, on what is considered to be utilisation, and on which user obligations apply. In all cases, national ABS rules of the provider country may remain applicable, as well as veterinary and other applicable regulations.
Scope of the EU ABS Regulation
The EU ABS Regulation can only apply when the three following conditions are met:
- the genetic resource is/was accessed on or after 12 October 2014;
- the genetic resource originated from a country that, at the time of access, is/was a Party the Nagoya Protocol and has/had established applicable ABS legislation; and
- research and/or development is or has been carried out on the genetic and/or biochemical composition of genetic resources within the EU (‘utilisation of genetic resources’).
If all three conditions are met, your activities with genetic resources may be in scope of the Regulation. Breeding animals and animal reproductive material (semen, embryos or eggs, for example) are considered to be genetic resources, as they contain functional units of heredity.
Utilisation of genetic resources in breeding
In the sense of the EU ABS Regulation, utilisation of genetic resources in animal breeding means research and development on the genetic and/or biochemical composition of the parent breeding animals and/or their progeny. Below, various examples are given of activities which are considered to be utilisation and activities which are not. The texts between brackets at the end of the examples refer to the relevant sections of the revised EU Guidance document.
Examples of activities considered to be utilisation
- Animal breeding which involves crossing and selection for desired traits, for the purpose of improving or changing the properties of established breeds (Annex II section 8.1).
- Scientific research on the genetic background of traits in breeding animals, to analyse which genes, gene complexes or regulatory sequences and mechanisms governing their expression are involved (Annex II section 6.2).
- Improvement of animals by genome editing, as it results from research and development activities on the genetic and/or biochemical composition of the given genetic resources (Annex II section 8.3).
Examples of activities not considered to be utilisation
- Acquisition of animals by farmers for direct production purposes only (milk or wool, for example), without breeding or other forms of research and development (Annex II chapter 2).
- Trading, transfer and exchange of breeding animals, as long as this does not involve research and development (Annex II chapter 5).
- Crossing and selection of breeding stock for the purpose of maintenance and conservation of rare and traditional breeds and varieties. No breed improvement through selection for desired traits takes place, as its sole aim is to secure survival of the breed or population. This also includes zoo breeding programmes. However, if the activities involve crossing and selection for the purpose of improving or changing the properties of established breeds, such activities would qualify as utilisation (Annex II chapter 5 and section 8.1).
- Breed assignment/identification and pedigree testing, as it does not involve the discovery of specific genetic and/or biochemical properties. This includes breed identification through morphological or molecular analysis and DNA sequencing (Annex II section 6.1).
- Development and application of reproductive technologies (in vitro fertilisation and semen sexing, for example). However, if the development requires investigation of the genetic and/or biochemical composition of animals of the target species, this would qualify as utilisation (Annex II section 8.2).
EU-recognised breeding books
As a breeder, it may be beneficial to take part in a breeding programme led by an officially recognised EU breeding society or operation. The products (offspring) of animal breeding may fall outside the scope of the EU ABS Regulation. After a product has been registered in a breeding book of an officially EU recognised breeding organisation as a new line or breed (according to Regulation (EU) 2016/1012), it is considered to be a new genetic resource and its further use in breeding is out of scope of the EU ABS Regulation. However, the breeding of these products may be in scope of the EU ABS Regulation (Annex II section 8.6).
To demonstrate that you have fulfilled your due diligence obligations as a user of a genetic resource that is in scope of the EU ABS Regulation, you may have to submit a due diligence declaration. A due diligence declaration should be submitted prior to placing a newly developed product (offspring) on the market or registering the product in an EU-recognised breeding book. For more information on due diligence declarations, read: ‘To DECLARE or not to DECLARE: when to submit a due diligence declaration’.
For more information on animal breeding and the EU ABS Regulation, see chapter 8 of Annex II and the previously indicated sections of the revised EU Guidance document.