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In brief

The new Delegated Regulation (EU) 2023/647 has amended the former Delegated Regulation (EU) 2020/686, which in turn complemented Regulation (EU) 2016/429, on the prevention and control of transmissible animal diseases, animal health requirements and traceability of animal reproductive products. The new Regulation complements the rules laid down in the original regulation as regards animal health issues of traceability and certification of movements of captive breeding products of terrestrial animals. Furthermore, the main objective of the regulation is to unify the different regulations applicable on this matter in order to improve their application and to avoid duplication or cross-references.

The new Delegated Regulation (EU) 2023/647 (DR2023), scheduled to enter into force on 10 April 2023, amends Delegated Regulation (EU) 2020/686 (DR2020), which supplemented Regulation (EU) 2016/429 (R2016), which lays down rules on the prevention and control of transmissible animal diseases, as well as animal health and traceability requirements applicable to movements within the European Union of consignments of animal reproductive products. The DR2020 introduced additional rules for breeding products, including traceability, animal health and certification requirements for the movement of breeding products of captive terrestrial animals within the European Union.

The DR2020 essentially resolved issues of legal uncertainty and proportionality of measures that had mainly been triggered by indications from member states and stakeholders on the DR2020. In this sense, the new DR2023, following a logical order, also seeks to complement the rules laid down in R2016 on various animal health aspects relating to traceability and certification of movements of breeding products of terrestrial animals in captivity. In addition, it aims to unify the different rules applicable to this sector in order to facilitate their application and thus avoid duplication and overlapping references.

Among the most significant changes since the adoption of DR2020, the new definition of embryo collection team now includes teams that collect and handle only unfertilized oocytes. The additional traceability requirements for sex-sorted semen are also extended to all processed products in order to improve traceability. Article 19 of DR2020, which provides for a derogation from the animal health requirements for different donor species, is also clarified. In particular, the degree of involvement of official veterinarians in these cases is elucidated.

In addition, the former Article 36 of DR2020 on animal health requirements applicable to movements of reproductive products from dogs and cats is deleted due to the lack of proportionality of the requirements and the lack of international standards justifying such conditions. In addition, the requirements on official certification and notification of movements of reproductive products from dogs and cats are also deleted. Part 2 of Annex II of DR2020 on additional animal health requirements for donor pigs is amended. The obligation to immediately move animals positive for infection with porcine reproductive and respiratory syndrome virus out of quarantine accommodation is considered disproportionate. Therefore, new monitoring options are provided in accordance with the different types of diagnostic methods used to confirm suspected cases of that disease. In addition, it is laid down that testing for swine fever carried out in pigs kept in semen collection centers is to be discontinued in countries that have neither notified classical swine fever nor vaccinated against classical swine fever in the previous twelve months, as the World Organisation for Animal Health (WOAH) rules do not require such testing to be carried out under those circumstances.

It also takes the opportunity to update references to epizootic hemorrhagic disease virus, specifying that all epizootic hemorrhagic disease serotypes are covered, allowing harmonization with other European Union acts. In addition, it seeks to follow more strictly the WOAH standards to have the option of a vector-free period as an optional measure to reduce the risk of infection. Annex III of DR2020 laying down additional animal health requirements for the addition of antibiotics to semen is amended, in that these requirements are streamlined and made optional. This decision is motivated by the fact that the WOAH rules are in the process of being amended with regard to the use of antibiotics.

Finally, in order to improve legal certainty, DR2023 corrects a number of substantial errors that have been identified, inter alia on the prevention of entry of unauthorized persons into semen collection centers and processing establishments for reproductive products.

For more information, the full text of the new DR2023 is available via this link.


Montserrat has extensive experience in pharmaceutical and health law, as well as in compliance, contract law, licensing, competition law and acquisitions in the pharmaceutical sector. She is the coordinator of the healthcare practice in the Barcelona office.
She assists healthcare companies throughout the life cycle of healthcare products (drugs, IVD and medical devices, combination products, cosmetics and food supplements), from R&D to commercialization and more specifically in the areas of clinical trials (agreements, regulatory procedures, processing of personal data), market access (pricing and reimbursement), products and companies regulations (MA/CE-marking, vigilances, required licenses, product classification, labelling), commercial relations between healthcare industries (distribution, (co)promotion, manufacturing, supply, licensing, partnership agreements), relations with healthcare professionals and/or patients including compliance (anti-gift and transparency laws); communication and advertising, e-health (connected devices, telemedicine, hosting of health data) and product liability. Her practice encompasses both advisory and litigation matters.
She also has considerable experience in the drafting of codes of professional ethics and conducting compliance audits, and advising on advertising and promotion of medicines and medical devices, including via the internet, online advertising and social media. Montserrat advises on a wide range of agreements related to the pharmaceutical industry, such as license and distribution agreements, clinical trial agreements, and supply and manufacturing agreements.

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