REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the Commission assessment of the situation as regards the treatment with medicinal products of animals of the equine species and their exclusion from the food chain, including with regard to imports of animals of the equine species from third countries
Date: 2025-11-19
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: drug surveillance, equidae, food contamination, health control, import (EU), market approval, third country, veterinary inspection, veterinary medicinal product

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   EUROPEAN COMMISSION  Brussels, 19.11.2025  COM(2025) 699 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the Commission assessment of the situation as regards the treatment with medicinal products of animals of the equine species and their exclusion from the food chain, including with regard to imports of animals of the equine species from third countries  
 
 
1. 

INTRODUCTION 

This report fulfils the Commission’s obligation as set out in Article 158 of Regulation (EU) 
2019/6 of the European Parliament and of the Council1 on veterinary medicinal products (the 
VMP Regulation) to assess the situation regarding the treatment of animals belonging to the 
equine species (e.g. horses, donkeys, mules, etc.) with veterinary medicinal products (VMPs), 
and their exclusion from the food chain, including with regard to imports from third countries 
(TCs). 

It also outlines the Commission’s conclusions on the possible actions to be taken to improve 
the current situation and their potential impact on public health, animal welfare, the risk of fraud 
and the level playing field with TCs. 

2.  BACKGROUND 

Under  EU  legislation2,  animals  of  the  equine  species  (also  known  as  ‘solipeds’,  ‘equids’, 
‘equine animal(s)’ or ‘Equidae’) are deemed to be food-producing animals3. To protect public 
health, equids must be irreversibly excluded4 from the food chain if they have been treated with 
medicinal products containing active substances prohibited for use in food-producing animals5 
or that are not allowed according to Regulation (EC) No 470/20096 (the MRL Regulation). The 
slaughter of food-producing  equids should be delayed  for six  months  where they have been 
administered substances included in the list of essential substances for the treatment of Equidae7 
(the  essential  substances  list  –  ESL).  Under  certain  conditions,  VMPs  authorised  for  other 

1  Regulation (EU) 2019/6 of the European Parliament and of the  Council of 11 December 2018 on veterinary 
(OJ  L  4,  7.1.2019,  p. 43,  ELI: 

repealing  Directive  2001/82/EC 

medicinal  products  and 
http://data.europa.eu/eli/reg/2019/6/OJ). 

2  Commission Implementing Regulation (EU) 2021/963 of 10 June 2021 laying down rules for the application 
of  Regulations  (EU)  2016/429,  (EU)  2016/1012  and  (EU)  2019/6  of  the  European  Parliament  and  of  the 
Council  with  regard  to  the  identification  and  registration  of  equine  animals  and  establishing  model 
identification  documents 
(OJ  L  213,  16.6.2021,  p. 3,  ELI: 
http://data.europa.eu/eli/reg_impl/2021/963/OJ). 

those  animals,  Article 38 

for 

3  Regulation (EU) 2019/6, Article 4(38). 
4  Commission Implementing Regulation (EU) 2021/963, Articles 38 to 42. 
5  Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain 
substances having a hormonal or thyrostatic action and of ß-agonists, and repealing Directives 81/602/EEC, 
88/146/EEC and 88/299/EEC (OJ L 125, 23.5.1996, p. 3, ELI: http://data.europa.eu/eli/dir/1996/22/OJ), read 
in combination with Annex I, Table 2 of Commission Regulation (EU) No 37/2010 of 22 December 2009 on 
pharmacologically active substances and their classification regarding maximum residue limits in  foodstuffs 
of animal origin (OJ L 15, 20.1.2010, p. 1, ELI: http://data.europa.eu/eli/reg/2010/37(1)/oj). 

6  Regulation  (EC)  No 470/2009  of  the  European  Parliament  and of  the  Council of 6 May  2009  laying  down   
Community  procedures  for  the  establishment  of  residue  limits  of  pharmacologically  active  substances  in 
foodstuffs  of  animal  origin,  repealing  Council  Regulation  (EEC)  No 2377/90  and  amending  Directive 
2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European 
Parliament and of the Council (OJ L 152, 16.6.2009, p. 11, ELI: http://data.europa.eu/eli/reg/2009/470/OJ). 
7  Commission Implementing Regulation (EU) 2025/901 establishing a list of substances which are essential for 
the  treatment of  equine  species,  or  which  bring  added  clinical  benefit  compared  to  other  treatment options 
available for equine species and for which the withdrawal period for equine species shall be six months (OJ L, 
2025/901, 20.5.2025, ELI: http://data.europa.eu/eli/reg_impl/2025/901/OJ) and Commission Regulation (EC) 
No 1950/2006 of 13 December 2006 establishing, in accordance with Directive 2001/82/EC of the European 
Parliament  and  of  the  Council  on  the  Community  code  relating  to  veterinary  medicinal  products,  a  list  of 
substances  essential 
(OJ  L  367,  22.12.2006,  p. 33,  ELI: 
http://data.europa.eu/eli/reg/2006/1950/OJ), as amended. 

treatment  of  equidae 

the 

for 

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animal  species or medicinal  products for human  use can be administered to  food-producing 
equids where there is no product authorised or available on the market for a given indication8.  

Under the current rules9, only the veterinarian responsible or the competent authority (CA) can 
exclude equids from the food chain. Many animals bred and raised in the EU and ending up in 
the food chain are former companion, sport or breeding animals. The social perception of equids 
as companion, sport or breeding animals and food-producing animals is often a challenge for 
the  implementation  of  legal  requirements  related  to  the  food  safety  risks  linked  to  their 
treatment with medicinal products. 

In  general,  the  market  in  veterinary  medicines  is  split  between  food-producing  animals  and 
companion animals; both sectors are to cover the treatment needs of many species. This results 
in a fragmented market10. For livestock farmers, animal treatment must be cost-effective. In 
addition, considerations by the animal health industry on return on investment and the cost of 
keeping a VMP on the market have been shown to deter the development of new veterinary 
medicines. This situation has a greater impact on medicines for less common indications and 
for  animal  species  with  lower  population  numbers.  For  example,  the  cost  of  providing  the 
required data for setting maximum residue limits (MRLs) for the active substance contained in 
a VMP may not justify the return on sales of that product in the case of food-producing equids. 

One  of  the  aims  of  the  VMP Regulation,  which  became  applicable  in  January  2022,  is  to 
increase the availability of VMPs, while guaranteeing the highest level of public and animal 
health and environmental protection. The VMP Regulation lays down specific provisions aimed 
at increasing the availability of medicinal treatments for equids and therefore improving their 
health and welfare, while also protecting public health.  

Some provisions are more general and are aimed at incentivising11 the authorisation of VMPs 
intended  for  limited  markets12,  such  as  for  equids.  Under  certain  conditions,  the  VMP 
Regulation  also  allows  the  use  of  medicinal  products  outside  the  terms  of  the  marketing 
authorisation13,  the  so-called  ‘cascade  use’.  These  conditions  are  specific  to  food-producing 
and to non-food-producing animals (such as equids excluded from the food chain). To increase 
the availability of medicines for food-producing equids, the VMP Regulation also provides for 
the establishment of a list14 of substances essential for the treatments of equids or which bring 
added clinical value compared to other treatment options available to equids and for which the 
withdrawal period must be six months. 

To ensure traceability and reliable exclusion from the food chain, equids in the EU  must be 
identified by the following means15: a unique code, physical means of identification (injectable 

8  Regulation (EU) 2019/6, Article 113 in combination with Article 115. 
9  Commission Implementing Regulation (EU) 2021/963, Article 38. 
10  Commission Staff Working Document Impact Assessment accompanying the Proposal for a Regulation of the 

European Parliament and of the Council on veterinary medicinal products /* SWD/2014/0273 final */. 

11  Regulation (EU) 2019/6, Article 23 (possibility to submit an application for limited markets without providing 

certain documentation) or Articles 39 and 40 (e.g. 14 years of initial data protection). 

12  Ibid., Article 4(29). 
13  Ibid., Articles 112, 113 and 115. 
14  Ibid., Article 115(5) and Commission Implementing Regulation (EU) 2025/901. Commission Regulation (EC) 

No 1950/2006, as amended by Regulation (EC) 122/2013, applies until 21 May 2027. 

15  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, Article 114(1) (OJ L 84, 
31.3.2016, p. 1, ELI: http://data.europa.eu/eli/reg/2016/429/OJ). 

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transponder  or  ear  tag)16  and  a  single  lifetime identification  document  (also  referred  to  as  a 
‘passport’)17. In general, equids need to be identified within a period to be determined by the 
Member  State  (MS)  and  before  they  reach  12 months  of  age,  or  before  they  leave  their 
establishment of birth for a period exceeding 30 days18. Delays in identification, as well as the 
loss of the passport or the physical identification of the animals must result in their exclusion 
from the food chain19, unless the operator can satisfactorily substantiate that the status of the 
equid  as  intended  for  slaughter  for  human  consumption  has  not  been  compromised  by  any 
medicinal treatment20. The passport also contains information on whether an individual equid 
is excluded from slaughter for human consumption or has received a medicinal treatment with 
substances in the ESL21. MSs are to establish and maintain databases22 containing the unique 
code, the identification code displayed by the transponder and details of the passport and of the 
animal23, as well as information on the animal’s status with regard to the food chain24 (‘food 
chain status’). 

The management of equids that have been excluded from the food chain can be challenging 
where their keeping is no longer wanted or possible for their owners. Since those animals are 
excluded from the food chain, they need to be kept until they die or be euthanised. However, in 
some MSs they cannot be euthanised without a reasonable cause. In some cases, the price of 
euthanasia and rendering may be prohibitive to owners. Therefore, the problem arises that some 
equids  may  end  up  without  treatment  to  avoid  being  excluded  from  the  food  chain,  and  if 
excluded  from  the  food  chain,  being  neglected  or  abandoned.  Both  situations  would  create 
serious animal health and welfare issues. In establishments especially dedicated to equid meat 
production  -  despite  their  relatively  low  number  in  Europe  -  exclusion  from  the  food  chain 
renders equids without any value whatsoever. Overall, these factors create conditions that may 
incentivise illegal and fraudulent practices, as evidenced by past and more recent cases25. This 
may include manipulating the passport, omitting to exclude equids from the food chain after 
treatment with medicines not allowed for food-producing animals, not recording the treatments 
with  such  medicines,  and  forgery  of  equids’  identification.  All  this  could  lead  to  the 
slaughtering of equids that should have been excluded from the food chain. 

16  Commission Delegated Regulation (EU) 2019/2035 of 28 June 2019 supplementing Regulation (EU) 2016/429 
of the European Parliament and of the Council as regards rules for establishments keeping terrestrial animals 
and hatcheries, and the traceability of certain kept terrestrial animals and hatching eggs, Articles 58 and 59 (OJ 
L 314, 5.12.2019, p. 115, ELI: http://data.europa.eu/eli/reg_del/2019/2035/OJ), as amended. 

17  Commission Implementing Regulation (EU) 2021/963. 
18  Ibid., Article 21. 
19   Ibid., Article 25(1) and (2)(d). 
20  Ibid., Article 38(2)(b). 
21  Commission Delegated Regulation (EU) 2021/577 of 29 January 2021 supplementing Regulation (EU) 2019/6 
of the European Parliament and of the Council as regards the content and format of the information necessary 
to apply Articles 112(4) and 115(5) and to be contained in the single lifetime identification document referred 
to 
ELI: 
http://data.europa.eu/eli/reg_del/2021/577/OJ). 

Article 8(4) 

Regulation 

9.4.2021, 

p. 3, 

123, 

that 

(OJ 

of 

in 

L 

22  Regulation (EU) 2016/429, Article 109. 
23  Commission Delegated Regulation (EU) 2019/2035 of 28 June 2019 supplementing Regulation (EU) 2016/429 
of the European Parliament and of the Council as regards rules for establishments keeping terrestrial animals 
and hatcheries, and the traceability of certain kept terrestrial animals and hatching eggs, Article 64 (OJ L 314, 
5.12.2019, p. 115, ELI: http://data.europa.eu/eli/reg_del/2019/2035/OJ), as amended. 

24  Commission Implementing Regulation (EU) 2021/963, Articles 6(1) and 7(2)(c). 
25  Professor Paddy Wall’s Report on equine identification, registration, and traceability in Ireland, available here. 

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Among  others,  the  requirements  for  entry  into  the  EU  set  out  in  Commission  Delegated 
Regulation (EU) 2022/229226 apply to food-producing equids and their products. That is to say 
that  equids  intended  for  slaughter  for  human  consumption  that  have  been  treated  with  the 
substances prohibited under Directive 96/22/EC, with the prohibited substances in Table 2 of 
the  Annex  to  Commission  Regulation  (EU)  No 37/2010  or  with  substances  not  included  in 
Table  1  of  that  Regulation,  or  meat  derived  from  such  equids  slaughtered  in  TCs,  are  not 
allowed to enter the EU. Only some countries are currently authorised to export live equids to 
the EU27 or meat from equids28. 

To collect and analyse evidence gathered between 2018 and 2022 on the current situation, the 
Commission  appointed  a  contractor  to  conduct  a  study  (‘the  study’).  In  its  report29,  the 
contractor examined several study questions, looked at the actions proposed by MS CAs and 
stakeholders to improve the current situation, and assessed the potential impact of those actions 
on public health, animal welfare, the risk of fraud and the level playing field with TCs. For the 
conduct  of  the  study,  the  contractor  carried  out  a  literature  search,  identified  the  sources  of 
relevant evidence and designed a consultation strategy. In a second step, the contractor gathered 
data and opinions from relevant CAs and stakeholders and analysed the available information.  

3.  ASSESSMENT OF THE CURRENT SITUATION 

As very limited or no data were available to the CAs and stakeholders for a number of study 
questions, it was not possible for the contractor to reach valid and representative conclusions at 
EU level. Gaps included, among others, accurate data on the reasons for  exclusion from the 
food  chain,  the  resort  to  euthanasia  as  a  result  of  exclusion  from  the  food  chain,  or  the 
percentage of animals treated with VMPs outside the terms of the marketing authorisation (MA) 
in  the  observation  period  2018-2022.  The  assessment  presented  below  focuses  on  the  core 
subject  of Article 158 of the VMP  Regulation, i.e. the treatment  with  medicinal  products  of 
equids and their exclusion from the food chain, including with regard to imports from TCs. 

The share of equids excluded from the food chain differs significantly between MSs, ranging 
from 5 to 95%. In some MSs with higher numbers of animals, the share ranges from 6 to 60%. 
Accurate  information  on  the  reasons  for  exclusion  is  not  widely  available.  This  makes  it 
difficult to conclude whether exclusion due to veterinary treatment or to a decision by the CAs 
(e.g. late identification; duplicate or replacement passports) is more likely. This is an important 
aspect, since the root causes leading to exclusion and the possible actions to avoid it may be 
different. 

26  Commission  Delegated  Regulation  (EU)  2022/2292  of  6 September  2022  supplementing  Regulation  (EU) 
2017/625 of the European Parliament and of the Council with regard to requirements for the entry into the 
Union of consignments of food-producing animals and certain goods intended for human consumption (OJ L 
304, 24.11.2022, p. 1, ELI: http://data.europa.eu/eli/reg_del/2022/2292/OJ). 

27  Commission  Implementing  Regulation  (EU)  2021/404  of  24 March  2021  laying  down  the  lists  of  third 
countries, territories or zones thereof from which the entry into the Union of animals, germinal products and 
products  of  animal  origin  is  permitted  in  accordance  with  Regulation  (EU)  2016/429  of  the  European 
Parliament and the Council (OJ L 114, 31.3.2021, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2021/404/OJ). 
28  Commission  Implementing  Regulation  (EU)  2021/405  of  24 March  2021  laying  down  the  lists  of  third 
countries or regions thereof authorised for the entry into the Union of certain animals and goods intended for 
human  consumption  in  accordance  with  Regulation  (EU)  2017/625  of  the  European  Parliament  and  of  the 
Council (OJ L 114, 31.3.2021, p. 118, ELI: http://data.europa.eu/eli/reg_impl/2021/405/OJ). 

29  OPERA Srl, Study on the situation as regards the medicinal treatment of animals of the equine species and 
their exclusion from the food chain - Final Report, EW-01-25-072-EN-N, European Union, Luxembourg, 2025, 
ISBN 978-92-68-28492-6, doi:10.2875/8634652, available at http://data.europa.eu/doi/10.2875/8634652 

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When it comes to the exclusion of equids from the food chain due to medicinal treatment, the 
main root cause is the lack of medicinal products that would allow the treated animal to stay in 
the food chain. 

The study captured opinions on the limitations to developing and authorising new VMPs for 
food-producing equids, which included the relatively small equine market when considering 
the costly MA procedures. This is compounded by the uncommon nature of some indications 
in equids, and the cost of providing the required data for setting MRLs, for determining the 
withdrawal period of the specific VMP and for maintaining that VMP on the market. For the 
provisions in EU law aimed at incentivising the availability of medicines for food-producing 
equids, MRL extrapolation under the MRL Regulation has proven to be of limited help, since 
the  cost  of  the  studies  on  the  withdrawal  period  for  the  specific  VMPs  is  the  main  limiting 
factor. More time is necessary to assess the impact of the new provisions in the VMP Regulation 
aimed  at  incentivising  medicines  availability  (e.g.  submission  of  applications  for  limited 
markets)30. 

The study could not provide data on the percentage of animals treated with a VMP that required 
their  exclusion  from  the  food  chain,  treated  with  a  substance  on  the  ESL  or  with  medicinal 
products used outside the terms of their MAs. However, it was reported as common that, when 
authorised VMPs available in other MSs are required under Article 113 of the VMP Regulation, 
the urgency of the treatment often results in the use of medicinal products which leads to the 
animal being excluded from the food chain.  

The  study  also  identified  a  general  lack  of  knowledge,  misunderstanding  or  disregard  for 
complex regulations, legal texts and guidelines on the use of VMPs among veterinarians and 
keepers of equids as contributing to the exclusion of equids from the food chain. This includes 
a lack of understanding of what constitutes the use of VMPs outside the terms of the MA in 
accordance with Article 112(4) or 113 of the VMP Regulation versus the so-called ‘off-label’ 
use, which is not allowed by the EU legislation.  

Animal  welfare  issues  linked  to  exclusion  from  the  food  chain,  for  example  animals  being 
abandoned  or  euthanised,  seem  to  be  rather  rare.  However,  such  issues  seem  to  be  more 
common for equids intended for meat production, which are often not provided with optimum 
treatments  in  order  to  avoid  them  being  excluded  from  the  food  chain.  This  leads  to  a 
consequent negative effect on the health and welfare of these animals. 

Excluding  equids  from  the  food  chain  may  result  in  fraudulent  activity  in  the  areas  of 
identification and documentary traceability in order to illegally reintroduce excluded animals 
into the food chain. Data from the EU Alert and Cooperation Network identified 60 cases of 
such reintroduction between 2018 and 2024 in the EU. Beyond animal welfare considerations, 
such fraudulent activities may lead to public health concerns since excluded animals may have 
been treated with prohibited substances for which no safe MRL can be established (i.e. no safe 
withdrawal period can be set). More broadly, these fraudulent activities have a negative and 
unfair  impact  on  the  reputation  of  animal  keepers  and  food  operators  who  do  uphold  EU 
legislation. 

The  study  found  that  the  existing  control  mechanisms  have  been  able  to  detect  fraudulent 
activity and non-compliances with EU rules. However, it also identified room for improvement 

30  According to the information available  on EMA’s website, since the VMP Regulation became applicable  a 
total  of  17  VMPs  intended  for  equine  animals  have  been  assessed  for  eligibility  under  Article 23,  with  10 
products having been considered as eligible. 

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in terms of cooperation and coordination among the involved CAs, setting-up whistleblowing 
procedures  and  strengthened  control  activities  to  facilitate  early  detection  and  appropriate 
follow-up of that fraudulent activity. The study also pointed to a number of actions to improve 
cooperation, notably the sharing of information contained within the national databases of MSs 
between CAs and with equine operators, and enhanced communication with stakeholders.  

In  relation  to  imports  from  TCs  of  food-producing  equids  or  their  products  into  the  EU,  no 
imports of live animals intended for slaughter took place during the observation period. Data 
shows that in 2022 almost 14 000 tonnes of the meat traded in the EU were imported and, in 
line with the previous years, Argentina was the main exporter, followed by Uruguay, Canada, 
Australia and the United Kingdom. A decreasing trend was observed over the study period in 
tonnes of meat imported from TCs, most notably from Canada and Australia. 

The Commission’s latest audit reports31 recommended that more robust systems and stricter 
enforcement  of  regulations  are  needed  in  TCs  to  increase  the  effectiveness  of  animal 
traceability. These measures would make it possible to identify and track any issues that may 
arise,  while  ensuring  that  animals  treated  with  certain  VMPs  are  not  intended  for  human 
consumption.  

Finally,  the  study  flags  discrepancies  between  the  import  requirements  laid  down  in 
Commission Delegated Regulation (EU) 2022/2292 and Council Directive 96/22/EC and the 
attestation included in the official import certificates (which currently requires attestation of 
compliance for a six-month period prior to slaughter). This results in a lack of a level playing 
field. 

4.  ASSESSMENT OF THE VIEWS OF STAKEHOLDERS AND CAS ON POTENTIAL EU ACTIONS 

TO IMPROVE THE CURRENT SITUATION 

The study compiled suggestions from national CAs and relevant stakeholders on actions that, 
in  their  view,  would  contribute  to  improving  the  current  situation.  Suggestions  could  be 
classified  into  four  categories:  (i)  those  that  had  already  been  addressed  in  current  EU 
legislation (so requiring no further assessment); (ii) those that were under implementation; (iii) 
those that can be implemented under the current EU legal framework, and (iv) those requiring 
changes to the relevant EU legislation to be implemented. The study assessed these suggestions 
considering their potential impact on public health, animal welfare, the risk of fraud and the 
level playing field with TCs.  

According to the assessment, most of the suggested actions that have been implemented or can 
be implemented under the current legal framework will improve the health and welfare of food-
producing equids, allowing more animals to legally stay in the food chain. This would, in turn, 
reduce the risk of no treatment to avoid exclusion from the food chain and the associated welfare 
risks such animals being abandoned or neglected. Reducing exclusion rates would also decrease 
the  incentive  for  criminal  activity  and  fraud.  Public  health  would  also  benefit  through  the 
decreased  risk  of  excluded  animals  treated  with  prohibited  and  non-allowed  substances  re-
entering the food chain illegally. 

4.1 Actions that were under implementation 

31  See  audit 

reports 

for  Uruguay  DG(SANTE)2018-6457  and  DG(SANTE)  2022-7448;  Canada 
DG(SANTE)2018-6458;  Argentina  DG(SANTE)2018-6459  and  DG(SANTE)  2022-7442;  Australia 
DG(SANTE)2019-6653 and DG(SANTE) 2019-6679. 

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4.1.1  Revision of the ESL 

The ESL was last updated in 2013. In line with Article 115(5) of the VMP Regulation, the 
Commission  has  adopted  Commission  Implementing  Regulation  (EU)  2025/901.  This 
Regulation  is  based  on  a  scientific  evaluation32  carried  out  by  the  European  Medicines 
Agency. The new list set by Regulation (EU) 2025/901 provides for a range of substances 
that  will  address  therapeutic  or  diagnostic  needs  that  cannot  currently  be  addressed  by 
existing medicinal products33, or that will bring an added clinical benefit compared to other 
available options.  

4.2 Actions that can be implemented under the current EU legal framework 

4.2.1  

Increasing the availability of VMPs for food-producing equids  

Specific provisions in the MRL Regulation and in the VMP Regulation were introduced 
with the aim to increase the availability of authorised VMPs and, as such, are considered as 
key enablers to improve the current situation. These provisions include, among others, MRL 
extrapolation34,  the  possibility  to  grant  MAs  for  limited  markets35,  the  increase  of  data 
protection periods36, the possibility to grant more than one MA for a specific VMP to the 
same  MA  holder37,  etc.  However,  the  study  also  signalled  that  additional  time  will  be 
needed for the application of the said provisions in the VMP Regulation to deliver its full 
potential.  

The study also found that the availability of VMPs already authorised in other MSs could 
be  further  supported  by  actions  such  as  the  smooth  implementation  of  the  subsequent 
recognition procedure (SRP)38 and the adoption of an attractive fee policy that would reduce 
the authorisation and maintenance costs of these VMPs in the new targeted MS(s).  

The study identified other possible actions, such as research or new modelling approaches 
on MRLs for equids being funded/sponsored by the EU. However, funding measures for 
individual  applicants  would  need  to  be  approached  with  caution  since  it  might  create  a 
market distortion. Furthermore, the Commission is already supporting the development of 
innovative  tools  and  methods  for  assessing  exposure  to  chemicals  and  reducing  animal 
testing via EU-funded instruments, such as the Partnership for the assessment of risks from 
chemicals - PARC39. Nevertheless, funding support or other actions such as an increased 
collaboration  at  EU  level  to  generate  clinical,  evidence-based  data  would  be  a  partial 
contribution. The costs of authorising the new VMPs (with the cost of the depletion studies 
necessary to set a safe withdrawal period being very high), their maintenance costs (e.g. 
annual fees, fees linked to variations either requiring or not requiring an assessment), and 

32  Scientific advice under Article 115(5) of Regulation (EU) 2019/6 for the establishment of a list of substances 
which are essential for the treatment of equine species, or which bring added clinical benefit compared to other 
treatment options available for equine species and for which the withdrawal period for equine species shall be 
six months (EMA/CVMP/159047/2023, 18 July 2024), available here. 

33  VMPs authorised for food-producing equids or the medicinal products referred to in Article 113 of the VMP 

Regulation. 

34   Regulation (EC) 470/2009, Article 5. 
35   Regulation (EU) 2019/6, Article 23. 
36   Ibid., Articles 39 and 40. 
37   Ibid., recital 54. 
38   Ibid., Article 53. 
39  Partnership for the Assessment of Risks from Chemicals | Parc (eu-parc.eu) 

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the low return of investments linked to a limited market, also represent financial challenges 
for companies, in particular SMEs. 

4.2.2.   Improving  knowledge  about  available  medicines  that  may  be  used  in  food-

producing equids  

The  study  identified  a  number  of  actions  requiring  collaboration  among  veterinarians, 
industry  stakeholders,  regulators  and  researchers  to  share  knowledge,  best  practices  and 
advances  in  treatment  for  equids,  including  at  international  level.  This  would  involve 
organising  conferences,  research  initiatives  and  creating  up  online  databases.  The 
preparation of treatment protocols with available VMPs and with essential substances could 
provide  meaningful  guidance.  This  could  include  updates  on  changes  in  relevant  EU  or 
national legislation so that veterinary practitioners become aware of their latest obligations. 

4.2.3.   Reinforcing controls on the use of VMPs in food-producing equids 

A strengthened enforcement of the relevant legislation concerning the use of medicines in 
food-producing equids would help decrease food fraud and thereby protecting public health, 
while  also  having  a  positive  effect  on  animal  welfare.  The  study  found  the  need  for  a 
coordinated approach among the relevant CAs and their divisions, both within and between 
MSs, with an efficient exchange of information and knowledge. To improve controls in this 
area, the study referred to the current national veterinary prescribing systems for collecting 
data  on  prescriptions.  However,  in  order  to  have  more  detailed  information  on  the 
prescription  and  use  of  VMPs  according  to  the  food-chain  status  of  the  treated  animals, 
communication with the national identification database would be required. 

4.2.4  

Improving the traceability of equids 

The study identified several actions to improve traceability, such as (i) the creation and use 
of a common EU identification database, (ii) granting private veterinary practitioners direct 
access to databases so that they can immediately record changes in the food chain status of 
the animals, and (iii) the digitalisation of animal passports. However, the objectives behind 
these actions can be achieved by applying the current EU legislation.  

For example, by granting read-only access to the MS national database to CAs of other MSs 
(or, as applicable, delegated bodies in those MSs), it would be possible to implement an 
EU-wide online system within which CAs could view and exchange information on animal 
identification, food chain status and movements. Veterinarians responsible could also have 
read-write access to that system to obtain the most up-to-date food chain status of an animal, 
and to update that status as required. A digital form of the passport (plastic cards, smart 
cards or digital applications on portable electronic devices) can also be authorised alongside 
a  standard  (paper)  version.  Finally,  the  envisaged  action  to  create  awareness  groups  at 
national level focused on animal identification could be grouped with other actions aimed 
at improving cooperation within national CAs and at raising awareness among veterinarians 
and animal keepers.  

4.3 Actions that would require changes to EU legislation to be implemented 

4.3.1.   Promoting a more flexible use of VMPs  

According  to  the  study,  stakeholders  have  requested  that  further  derogations  from 
Article 106(1) of the VMP Regulation should be allowed so that VMPs could be used in 

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line with the latest scientific advice, even if such advice is not in line with the summary of 
product characteristics (SPC). One example would be allowing the veterinarian to reduce 
or increase the dose, or change the frequency or the route of administration. According to 
the VMP Regulation, derogation from that article in food-producing equids is only possible 
in  accordance  with  Article 113,  read  in  combination  with  Article 115.  Stakeholders 
consider that allowing  such flexibility would  enable a  better management  of diseases  or 
injuries  in  animals  and  provide  veterinarians  with  legal  certainty  when  treating  those 
animals. However, since the exclusion of the treated animals from the food chain is only 
triggered  by  the  active  substance  contained  in  the  medicinal  product  used,  the  proposed 
flexibility would not improve the current situation.  

Nevertheless,  deviations  from  the  SPC  would  mean  that  VMPs  are  used  outside  the 
conditions that have been evaluated by the  CAs granting the MA and that guarantee the 
quality, safety and efficacy of the VMP concerned. Such deviations may therefore lead to 
public  health  concerns  due  to  the  potential  effects  of  using  higher  doses  or  longer  dose 
regimes on the safety of the authorised withdrawal periods and the presence of residues in 
food.  Furthermore,  there  is  a  public  health  concern  linked  to  antimicrobial  resistance 
(AMR). In that respect, any deviation from the SPC resulting in a lower efficacy of a given 
VMP would also negatively impact on the welfare of the treated animal.  

4.3.2.   Amendment of criteria for exclusion from the food chain 

The study reported possible actions to remove the permanent exclusion from the food chain, 
including a temporary withdrawal period clause (e.g. six months to one year) when VMPs 
leading to exclusion are used or for administrative reasons, such as late identification of the 
animal or the issuing of a replacement passport40. 

According to the study, stakeholders claimed that a one-year withdrawal period could be 
enough to cover almost all residues of VMPs. Nevertheless, withdrawal periods should be 
calculated on a case-by-case basis, taking into account  the full composition  of the VMP 
(e.g. active substance and excipients), the administration route and its dose regime. This 
measure would prospectively allow animals to receive a wider range of veterinary treatment 
while  remaining  in  the  food  chain.  However,  these  animals  would  not  be  allowed  to  be 
treated with prohibited substances, and strict monitoring processes would be necessary to 
ensure that the withdrawal period is adhered to.  

According  to  some  stakeholders,  this  suggestion  would  create  a  level  playing  field  for 
imports from TCs. However, such a measure would entail a differential treatment of food-
producing equids under EU legislation, resulting in a lower level of consumer protection 
for this species compared to other animal species (e.g. cattle, sheep, pigs, poultry, etc.). This 
could, in turn, undermine the reputation and consumer acceptance of horse meat. 

This proposal could contribute to addressing some animal welfare issues (e.g. animals not 
receiving necessary treatment in order to avoid exclusion) and to reducing the number of 
excluded animals in future, thus preventing their illegal reintroduction into the food chain. 
However, the removal of the permanent exclusion from the food chain and the inclusion of 

40  Unless  the  operator  can  satisfactorily  substantiate  that  the  status  of  the  equid  as  intended  for  slaughter  for 

human consumption has not been compromised by any medicinal treatment. 

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a temporary withdrawal period clause could not be applied to animals currently excluded 
since it could result in animals treated with prohibited substances re-entering the food chain.  

4.3.3.   Systematic exclusion of equids from the food chain 

This proposed measure would concern all equids except for those specifically bred for food 
production.  As  reported  in  the  study,  segregation  between  leisure/competition  and  food-
producing  animals  would  be  difficult  since  an  equid  does  not  fit  into  only  one  category 
during  its  entire  lifespan.  Therefore,  creating  a  standard  category  of  ‘equine  companion 
animal’ excluding the animal from the food chain as a foal would lead to several issues. The 
need for lifelong maintenance could have welfare implications for animals that become an 
expensive burden and have no alternative use, with unpredictable consequences in terms of 
neglected  or  abandoned  animals.  As  a  result,  fraudulent  and  criminal  activity  aimed  at 
illegally  reintroducing  these  excluded  animals  into  the  food  chain  are  likely  to  increase. 
This would, in turn, have an obvious negative impact on public health since these animals 
might  have  been  treated  with  prohibited  substances  for  which  no  safe  MRL  can  be 
established.  

5.  CONCLUSIONS 

The exclusion of equids from the food chain due to medicinal treatment is mainly driven by the 
lack of medicinal products that would allow the treated animal to stay in the food chain. 

In  this  respect,  cooperation  among  all  stakeholders  contributing  to  innovation  and  the 
development  of  VMPs  for  food-producing  equids  (animal  keepers,  veterinarians,  academia, 
animal  health industry and regulators) would be  crucial to  identify existing  needs, prioritise 
research on them, and facilitate technology transfer, product development and the regulatory 
steps leading to a VMP being authorised and kept on the market. 

More time will be needed for the  VMP  Regulation to  achieve its  full  potential  and  increase 
medicines  availability.  The  progressive  submission  of  applications  for  the  authorisation  of 
VMPs that have been deemed eligible for limited markets will contribute to this. Wider EU 
availability of VMPs already authorised in other MSs could be further enhanced by a smooth 
implementation of the SRP and the adoption of an attractive fee policy that would reduce the 
authorisation and maintenance costs of these products in the new targeted MS(s). Furthermore, 
the  new  ESL  will  also  help  to  increase  medicines  availability  by  addressing  therapeutic  or 
diagnostic needs that cannot currently be addressed by medicinal products that can be used in 
food-producing equids. 

Veterinarians play a key role in the prescription and use of VMPs in accordance with EU and 
national  rules.  This  includes  the  exclusion  of  equids  from  the  food  chain  due  to  medicinal 
treatment. The veterinary profession, in close cooperation with national CAs, should continue 
helping to raise awareness among veterinary practitioners and animal keepers of the relevant 
legislation;  namely  on  the  identification  of  equids  and  the  use  and  recording  of  veterinary 
treatments. This may involve the design of national guidelines or specific treatment protocols, 
including on the use of medicinal products outside the terms of the MA and of substances on 
the ESL, or the organisation of specific training campaigns (including on updates to the relevant 
national or EU legislation). 

Reinforced  cooperation  and  coordination  among  the  national  CAs  involved,  as  well  as 
strengthened enforcement, are crucial to identify fraudulent activities and non-compliance with 

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the  applicable  EU  rules.  That  reinforced  cooperation  would  involve  sharing  information 
contained within the national databases between  MS CAs and also with equine operators on 
identification,  movement  and  food  chain  status,  maximising  the  potential  of  the  current 
legislation. It could also be complemented by enhanced communication and awareness rising 
campaigns with relevant stakeholders. Sound, well-established whistleblowing procedures are 
also crucial for the early detection of fraud signals and the triggering of the relevant control 
actions by CAs. 

Implementing the actions mentioned above will contribute to improving the current situation. 
Animal  welfare  will  be  enhanced  through  the  availability  of  more  appropriate  medicinal 
treatments for equids, avoiding their exclusion from the food chain and the potential welfare 
risks  (e.g.  animals  not  being  treated  to  avoid  exclusion).  Reducing  the  number  of  excluded 
animals will also decrease the chances of criminal activity and fraud, and the risks that these 
activities pose to public health and animal welfare. Finally, the strengthened enforcement of 
EU law will also help to create a more dissuasive environment for fraud.  

Against this background, the Commission will promote, in close cooperation with MS CAs and 
stakeholders, the implementation of the actions mentioned above under the existing EU legal 
framework  in  order  to:  (i)  increase  medicines  availability  for  food-producing  animal  of  the 
equine species; (ii) increase awareness among veterinarians and animal keepers of the EU rules 
on the use of medicinal products in food-producing equids and their exclusion from the food 
chain;  and  (iii)  reinforce  cooperation  and  coordination  among  national  CAs,  as  well  as 
enforcement activities.  

On the level playing field for imports from TCs, the Commission is working on a proposal to 
amend Annex III to Commission Implementing Regulation (EU) 2020/223541 and Annex II to 
Commission  Implementing  Regulation  (EU)  2021/40342  as  regards  the  model  certificates 
required for entry into the EU of consignments of certain products of domestic and wild game 
solipeds and certain categories of equine animals, respectively. This amendment will align the 
attestation  in  the  relevant  certificates  with  the  lifetime  EU  requirements  laid  down  in 
Commission Delegated Regulation (EU) 2022/2292 and Council Directive 96/22/EC to ensure 
a level playing field for the rules currently in force.  

Furthermore,  the  Commission  will  continue  to  audit  exporting  countries  to  evaluate  their 
official control systems for animal products intended for export to the EU, including horse meat.  

41  Commission  Implementing  Regulation  (EU)  2020/2235  of  16 December  2020  laying  down  rules  for  the 
application of Regulations (EU) 2016/429 and (EU) 2017/625 of the European Parliament and of the Council 
as  regards  model  animal  health  certificates,  model  official  certificates  and  model  animal  health/official 
certificates, for the entry into the Union and movements within the Union of consignments of certain categories 
of  animals  and  goods,  official  certification  regarding  such  certificates  and  repealing  Regulation  (EC) 
No 599/2004,  Implementing  Regulations  (EU)  No 636/2014  and  (EU)  2019/628,  Directive  98/68/EC  and 
(OJ  L  442,  30.12.2020,  p. 1,  ELI: 
Decisions  2000/572/EC,  2003/779/EC  and  2007/240/EC 
http://data.europa.eu/eli/reg_impl/2020/2235/OJ). 

42  Commission Implementing Regulation (EU) 2021/403 of 24 March 2021 laying down rules for the application 
of Regulations (EU) 2016/429 and (EU) 2017/625 of the European Parliament and of the Council as regards 
model animal health certificates and model animal health/official certificates, for the entry into the Union and 
movements between Member States of consignments of certain categories of terrestrial animals and germinal 
products thereof, official certification regarding such certificates and repealing Decision 2010/470/EU (OJ L 
113, 31.3.2021, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2021/403/OJ). 

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LIST OF ABBREVIATIONS 

AMR    

Antimicrobial resistance  

CA 

ESL 

MA 

MRL 

MS 

SPC 

SRP 

TCs 

VMP 

Competent authority 

Essential substances list 

Marketing authorisation 

Maximum residue limit  

Member State 

Summary of the product characteristics 

Subsequent recognition procedure 

Third countries 

Veterinary medicinal product 

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