II
(Non-legislative acts)
REGUL ATIONS
COMMISSION DELEGA TED REGUL ATION (EU) 2023/647 
of 13 Januar y 2023
amending Delegated Regulation (EU) 2020/686 supplementing Regulation (EU) 2016/429 of the 
European Parliament and of the Council as regards the appro val of germinal product establishments 
and the traceability and animal health requirements for movements within the Union of germinal 
products of certain kept terrest rial animals 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on 
transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health 
Law’) (1), and in particular Article 160(1) and (2), and Articles 162(4) and 164(2) thereof,
Whereas:
(1) Regulation (EU) 2016/429 lays down rules for the prevention and control of animal diseases which are transmissible 
to animals or humans, including rules for the registration and appro val of germinal product establishments, and for 
the traceability and animal health requirements for movements of consignments of germinal products within the 
Union. Regulation (EU) 2016/429 also empowers the Commission to adopt rules to supplement certain non- 
essential elements of that Regulation by means of delegat ed acts.
(2) Commission Delegat ed Regulation (EU) 2020/686 (2)lays down supplementing rules for the approval of germinal 
product establishments, record keeping and traceability of germinal products, as well as animal health and 
certification requirements for mov ements within the Union of germinal products of certain kept terrestrial animals.
(3) The rules laid down in this Regulation are required to supplement those laid down in Part IV, Title I, Chapt er 5, of 
Regulation (EU) 2016/429 as regards the traceability and animal health requirements and animal health 
certification requirements for movements within the Union of consignments of germinal products of certain kept 
terrestrial animals in order to prevent the spread of transmissible animal diseases within the Union by those 
products.
(4) These rules are substantively linked and many are intended to be applied in tandem. In the inter ests of simplicity and 
transparency , as well as to facilitate their application and to avoid a multiplication of rules, they theref ore should be 
laid down in a sing le act rather than in a number of separate acts with man y cross-ref erences and the risk of 
duplication.
(1)OJ L 84, 31.3.2016, p. 1.
(2)Commission Delegat ed Regulation (EU) 2020/686 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European 
Parliament and of the Council as regar ds the approval of germinal product establishments and the traceability and animal health 
requirements for movements within the Union of germinal products of certain kept terrestrial animals (OJ L 174, 3.6.2020, p. 1).EN Offi cial Jour nal of the European Union 21.3.2023 L 81/1  (5) Dur ing the implementation of Deleg ated Regulation (EU) 2020/686 several Member States and stakeholders 
indicated that follo wing recent developments and specialisations in the germinal product sector , the definition of 
embr yo collection team should also include a team whic h only collects and handles unfer tilised oocyt es. That 
definit ion and the relat ed requirements should theref ore be amended to cover such a team.
(6) Germinal product establishments of processing may engage in other processes than sex-sor ting of semen. In the 
inter est of the traceability of the processed products, the supplementar y traceability requirements previously 
applicable only to sex-sor ted semen should be equally extended to all processed products.
(7) Article 19 of Deleg ated Regulation (EU) 2020/686 lays down a derogation from the animal health requirements for 
donor bovine , porcine, ovine, capr ine and equine animals move d between semen collection centres. Exper ience from 
Member State s and stake holders with the implementation of that Article have indicated legal uncer tainty as regar ds 
the degree of involvement of official veterinar ians. That Article should theref ore be clarified.
(8) Article 36 of Delega ted Regulation (EU) 2020/686 lays down animal health requirements for movements within the 
Union of germinal products of dogs and cats, mainly to mitigat e rabies and promote compl iance with preventive 
animal health measures against Echinococcus multilocular is. Member States and stak eholders have questioned the 
relevance and propor tionality of these requirements. As the relevant intern ational standards of the World 
Org anisation for Animal Health (WOAH) do not contain comparable requirements, Article 36 of Deleg ated 
Regulation (EU) 2020/686 and relat ed wording in requirements concer ning official certification and notification of 
mov ement of germinal products of dogs and cats between Member States should be deleted.
(9) Part 2 of Annex II to Deleg ated Regulation (EU) 2020/686 lays down additional animal health requirements for 
porcine donor animals. In accordance with Part 2, Chapt er I, point 1(c)(iv), of that Annex, animals positive for 
infection with porcine reproductive and respirato ry syndrome virus are to be removed immediately from the 
quarantine accomodation. Member States and stak eholders have questioned the propor tionality of this requirement 
in the light of practical and scientifi cally proven difficulties with current diagnostic methods. Theref ore, Delegat ed 
Regulation (EU) 2020/686 should be amended in order to provi de for different possibilities of follow-up when 
using different types of diagnostic methods to conf irm or rule out suspect ed cases in accordance with Commission 
Delegat ed Regulation (EU) 2020/689 (3).
(10) Part 2 of Annex II to Delegat ed Regulation (EU) 2020/686 lays down additional animal health requirements, 
including testing for classical swine fever of porcine animals kept at semen collection centres. However , the relevant 
internati onal standards of the WOAH do not require testing of such animals in countr ies where outbreaks of 
classical swine fever have not been repor ted and vaccination against this disease has not been practised in the 
preceding 12 months. Theref ore, testing for that disease of porcine animals kept at semen collection centres should 
be discontinued in those countr ies whic h neither have repor ted classical swine fever , nor have vaccinated against it 
in the preceding 12 months.
(11) References to the epizootic haemor rhagic disease virus should be amended to align them with references to that 
virus in other Union acts and to clarify that all serotypes of that virus are covered by the rules. In addition, 
requirements relat ed to infection with epizootic haemor rhagic disease virus should more closely follow 
internati onal standards of the WOAH to provide for the possibility of a vector -free period as an optional and 
additional risk mitigating measure relat ed to that infection, to ensure safe trade in germinal products of bovine, 
ovine and capr ine animals.
(3)Commission Delegat ed Regulation (EU) 2020/689 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European 
Parliament and of the Council as regar ds rules for surveillance, eradication programmes, and disease-free status for certain listed and 
emerging diseases (OJ L 174, 3.6.2020, p. 211).EN Offi cial Jour nal of the European Union L 81/2 21.3.2023  (12) Annex III to Delegat ed Regulation (EU) 2020/686 lays down additional animal health requirements with respect to 
the addition of antibiotics to semen, including their compulso ry addition to semen of bovin e and porcine animals. 
While those requirements are in line with internati onal standards of the WOAH, those international standards are 
in the process of being amended, towards the voluntar y, more flexible and prudent use of antibiotics. In addition, 
information from scientifi c literature, Member States and stake holders indicates similar needs. Theref ore, the 
relevant requirements should be streamlined and made optional.
(13) After the publication of Delegat ed Regulation (EU) 2020/686 in the Official Journal of the Europ ean Union, some 
substantial errors were spott ed. In particular , the wording in relation to the prevention of the entr y of unauthor ised 
persons to semen collection centres and germinal product processing establishments creat ed legal uncer tainty . 
Further more, an incor rect referen ce in the text applicable to certain equine animals entering semen collection 
centres for equine animals unint entionally changed the requirements whose fulfilment centre veteri narians are to 
ensure. In the interest of legal certainty and clarity, those errors should be correcte d.
(14) Delegat ed Regulation (EU) 2020/686 should theref ore be amended and correcte d according ly,
HAS ADOPTED THIS REGUL ATION:
Article 1
Delegat ed Regulation (EU) 2020/686 is amended as follows:
(1) in Article 1(7), point (a) is deleted;
(2) in Article 2, point (12) is replaced by the following:
‘(12) “embr yo collection team ” means a germinal product establishment compris ed of a group of professionals or a 
structure appro ved by the compet ent author ity for the collection, processing, stora ge and transpor t of oocytes or in 
vivo derived embr yos of bovin e, porcine, ovine, capr ine or equine animals intended for mov ement to another 
Member State, as refer red to in Article 4;’;
(3) in Article 3, point (b) is replaced by the follo wing:
‘(b) the group of profess ionals or the structure super vised by a team veterinar ian compet ent to perform the 
collection, processing and storag e of oocytes or embr yos of bovine, porcine, ovine, capr ine or equine animals for 
appro val as an embr yo collection team;’;
(4) in Article 4(1), point (b)(ii) is replaced by the followi ng:
‘(ii) Part 2, point 2, of Annex I, in respect of the collection, processing, storag e and transpor t of oocyte s or embr yos 
of bovine, porcine, ovine, capr ine or equine animals;’;
(5) in Article 10, paragraph 2 is replaced by the followi ng:
‘2. In case of a germinal product processed in a germinal product establishment other than the germinal product 
establishment of collection, the operator of the germinal product establishment of processing shall supplement the 
information refer red to in paragraph 1 with information which permits the identification of the unique appro val 
number of the establishment of processing of that germinal product.’ ;
(6) in Article 19, paragraph 2 is replaced by the followi ng:
‘2. Operators shall only move donor animals, as refer red to in the introduct ory phrase of paragraph 1, with the 
prior consent of the centre veterinar ian of the semen collection centre of destination.’ ;
(7) Article 36 is deleted;
(8) Article 39 is amended as follows :
(a) paragraph 1 is delet ed;EN Offi cial Jour nal of the European Union 21.3.2023 L 81/3  (b) paragraph 4 is replaced by the followi ng:
‘4. The official veteri narian shall carry out the checks and examinations as provi ded for in paragraphs 2 and 3 
and issue the animal health certificate within the period of 72 hours preceding the time of dispatch of the 
consignment of germinal products.’ ;
(9) Article 40 is replaced by the following:
‘Article 40
Animal health certification requirements for movements of consignments of germinal products of kept 
terrest rial animals other than bovine, porcine, ovine, capr ine or equine animals betw een Member States
The animal health certificates for mov ements between Member State s of consignments of germinal products of 
terrestr ial animals other than bovine, porcine, ovine, capr ine or equine animals kept at conf ined establishments and 
of animals of the family Camelidae or Cervidae, shall contain at least the information set out in point 2 of Annex IV.’;
(10) Article 41 is replaced by the following:
‘Article 41
Requirement for advance notif ication by operat ors of movements of consignments of germinal products of 
kept terrestrial animals other than bovine, porcine, ovine, capr ine or equine animals betw een Member States
Where consignments of germinal products of terrestr ial animals other than bovine, porcine, ovine, capr ine or equine 
animals kept at conf ined establishments or of animals of the family Camelidae or Cervidae are move d to another 
Member State, the operat or shall notify the compet ent author ity in the Member State of origin of the consignments 
in advance of the intended movement of those consignments of germinal products.’ .
Article 2
Annex es I to IV to Deleg ated Regulation (EU) 2020/686 are amended in accordance with Part A of the Annex to this 
Regulation.
Article 3
Annex I to Deleg ated Regulation (EU) 2020/686 is corrected in accordance with Part B of the Annex to this Regulation.
Article 4
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 13 Januar y 2023 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 81/4 21.3.2023  ANNEX 
PART A
Annex es I to IV to Delegat ed Regulation (EU) 2020/686 are amended as follows :
(1) Annex I is amended as follows:
(a) Part 2 is amended as follows:
(i) point 1(a)(v) is replaced by the followi ng:
‘(v) the marking of straws and other packag es where oocyt es or in vivo derived embr yos are placed in 
accordance with the requirements set out in Article 10(1) and (5);’;
(ii) point 2 is replaced by the followi ng:
‘2. The facilities, equipment and operational procedures of the embr yo collection team , as refer red to in 
Article 4(1), point (b)(ii), shall compl y with the followi ng points (a) and (b):
(a) the embr yo collection team must have at its disposal a laborat ory where oocyte s or in vivo derived 
embr yos can be examined, processed and packag ed with adequate equipment, and that laboratory 
must be either:
(i) a permanently locat ed laboratory , which must have the following:
— a room where oocytes or in vivo derived embr yos can be processed which is physically 
separated from the area used to handle the donor animals during collection,
— a room or area for cleansing and sterilis ing instr uments used for oocyte s or in vivo derived 
embr yo collection and processing, excep t when using only new sing le-use equipment,
— a room for the storing of oocytes or in vivo derived embr yos;
or
(ii) a mobile laborat ory, which must :
— have a specially equipped part of the vehicle consisting of two separate sections: one section 
for the examination and processing of oocytes or in vivo derived embr yos, whic h must be the 
clean section; and another section for accommodating equipment and mater ials used in 
contact with the donor animals,
— use only new sing le-use equipment, unless the sterilisation of its equipment and the provision 
of fluids and other products necessar y for the collection and processing of oocytes or in vivo 
derived embr yos is carried out at a permanently locat ed laboratory .
The laboratories referred to in points (i) and (ii) must be designed and have a layout so as to prevent 
the cross-contamination of oocyt es or in vivo derived embr yos, and team operations shall be 
carried out in a manner that prevents such cross-contamination;
(b) the embr yo collection team must have at its disposal storag e premises which compl y with the 
followi ng conditions:
(i) they compris e at least one lockable room for the storage of oocyt es or in vivo derived embr yos;
(ii) they must be easy to cleanse and disinfect ;
(iii) they must have permanent records of all incoming and outgoing oocyt es or in vivo derived 
embr yos;
(iv) they must have storag e containers for oocyte s or in vivo derived embr yos.’;
(b) in Part 5, point 2(d) is delet ed;EN Offi cial Jour nal of the European Union 21.3.2023 L 81/5  (2) Annex II is amended as follows:
(a) in Part 2, Chapt er I, point 1(c)(iii) is deleted;
(b) in Part 2, Chapt er I, point 1(c)(iv) is replaced by the followi ng:
‘(iv) as regards infection with porcine reproductive and respirato ry syndrome virus, a serological test (IPMA, IFA, 
or ELISA) or a test for virus genome (reverse-transcr iption polymerase chain reaction (RT-PCR), nested set 
RT-PCR, real-time RT-PCR).
If any of the animals prove positive in the serological tests for infection with porcine reproductive and 
respirato ry syndrome virus, the compet ent author ity shall classify all animals in the quarantine 
accommodation as a suspecte d case in accordance with Article 9(1), point (b), of Delegat ed Regulation 
(EU) 2020/689. The operator shall isolat e the positive animals immediat ely from other animals within the 
quarantine accommodation. The compet ent author ity shall conduct an investigation to confir m or to rule 
out infection with porcine reproductive and respirato ry syndrome virus in accordance with Article 8 of 
Deleg ated Regulation (EU) 2020/689.
If any of the animals prove positive in the tests for virus genome for porcine reproductive and respirato ry 
syndrome virus, the compet ent author ity shall classify all animals in the quarantine accommodation as a 
confir med case in accordance with Article 9(2), point (b), of Delegat ed Regulation (EU) 2020/689. The 
operat or shall remo ve those animals immediately from the quarantine accommodation and follow the 
instr uctions of the compet ent author ity.’;
(c) in Part 2, Chapt er I, point 2(a)(iii) is replaced by the following:
‘(iii) as regards classical swine fever, an antibody ELIS A or serum neutralisation test, in case of animals in a Member 
State or zone thereof where classical swine fever has been repor ted or vaccination against this disease has 
been practiced for the period of the preceding 12 months;’;
(d) in Part 5, Chapt er III is replaced by the followi ng:
‘CHA PTER III
Requir ements for bovine, ovine and capr ine animals as regards infection with the epizootic haemor rhagic 
disease virus
1.The bovine, ovine and capr ine animals whic h are semen donors must fulfil at least one of the follo wing 
conditions:
(a) they have been kept for a period of at least 60 days prior to and during collection of the semen in a Member 
State or zone thereof where infection with epizootic haemor rhagic disease virus has not been repor ted for a 
period of at least the preceding 2 years within a radius of 150 km of the establishment ;
(b) they have been kept for a period of at least 60 days prior to and during collection of the semen in a Member 
State or zone thereof seasonally free from infection with epizootic haemor rhagic disease virus;
(c) they have been kept in a vector -prote cted establishment for a period of at least 60 days prior to and during 
collection of the semen;
(d) they have been subjecte d to a serological test to detect antibodies to infec tion with epizootic haemor rhagic 
disease virus, with negativ e results, at least ever y 60 days throughout the collection period and between 28 
and 60 days from the date of the final collection of the semen;
(e) they have been subjected to an agent identif ication test for infection with epizootic haemor rhagic disease 
virus, with negative results, on blood sample s taken at commencement and final collection of the semen 
and during collection of the semen at inter vals of:
(i) at least ever y 7 days, in the case of virus isolation test; or
(ii) at least ever y 28 days, in the case of PCR.EN Offi cial Jour nal of the European Union L 81/6 21.3.2023  2.The bovine, ovine and capr ine animals which are oocyte donors for the in vitro production of embr yos and in 
vivo derived embr yo donors must fulfil at least one of the followi ng conditions:
(a) they have been kept for a period of at least 60 days prior to and during collection of the oocytes or embr yos 
in a Member State or zone thereof where infec tion with epizootic haemor rhagic disease virus has not been 
repor ted for a period of at least the preceding 2 years within a radius of 150 km of the establishment ;
(b) they have been kept for a period of at least 60 days prior to and during collection of the oocytes or embr yos 
in a Member State or zone thereof seasonally free from infection with epizootic haemor rhagic disease virus;
(c) they have been kept in a vector -prote cted establishment for a period of at least 60 days prior to and during 
collection of the oocyt es or embr yos;
(d) they have been subjecte d to a serological test to detect antibodies to infec tion with epizootic haemor rhagic 
disease virus, with negative results, on a blood sample taken between 28 and 60 days from the date of 
collection of the oocyt es or embr yos;
(e) they have been subjected to an agent identif ication test for infection with epizootic haemor rhagic disease 
virus, with negative results, on a blood sample taken on the date of collection of the oocyt es or embr yos.
3.The semen used to fertilise the oocyte s must be collect ed from animals whic h compl y with the requirements set 
out in point 1.’;
(3) Annex III is amended as follows :
(a) in Part 1, point 3 is replaced by the followi ng:
‘3. Where necessar y, antibiotics or mixtures of antibiotics may be added to semen or contained in semen diluents.’;
(b) in Part 1, points 4 and 5 are delet ed;
(4) in Annex IV, in point 2, the introductor y wording is replaced by the following:
‘The animal health certificate for the germinal products of terrestrial animals other than bovine, porcine, ovine, capr ine 
or equine animals kept at confined establishments and of animals of the family Camelidae or Cervidae mov ed between 
Member State s, refer red to in Article 40, shall contain at least the follo wing information:’.
PART B
Annex I to Deleg ated Regulation (EU) 2020/686 is corrected as follows:
(1) in Part 1, point 1(a)(iii) is replaced by the followi ng:
‘(iii) the entr y of unauthor ised persons is effectively prevented ;’;
(2) in Part 1, point 1(e) is replaced by the followi ng:
‘(e) the centre veterinar ian of a semen collection centre for equine animals, located within the perimeter s of a registere d 
establishment whic h also hosts an artificial insemination or service centre, shall ensure that equine animals 
enteri ng the establishment meet the requirements of Article 23(1), point (a), and may decide that where direct 
contact of donor male equine animals with female equine animals or castrated male equine animals for teasin g or 
with uncastrat ed male equine animals used on the establishment outside the semen collection centre for natural 
service cannot be excluded, those female and male equine animals must meet all the requirements of Article 23(1).’;
(3) in Part 4, point 1(a)(ii) is replaced by the follo wing:
‘(ii) the entr y of unauthor ised persons is effectively prevent ed;’.EN Offi cial Jour nal of the European Union 21.3.2023 L 81/7