EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10216/2022 Rev. 1 
(POOL/E2/2022/10216/10216R1 -
EN.docx)  
[…](2022) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
supplementing Regulation (EU) 2017/625 of the European Parliament and of the 
Council with specific requirements for the performance of official controls on the use of 
pharmacologically active substances authorised as veterinary medicinal products or as 
feed additives and of prohibited or unauthorised pharmacologically active substances 
and residues thereof  
(Text with EEA relevance)    
EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
Regulation (EU) 2017/625 of the European Parliament and of the Council lays down 
rules on official controls and other official activities.  
Article 19(1) of Regulation (EU) 2017/625 lays down specific rules on official 
controls in relation to the residues of relevant substances in food and feed in order to 
verify compliance, amongst others, with  Union legislation on f eed and food safety.  
Article 19(2) of Regulation (EU) 2017/625 empowers the Commission to lay down 
rules for the performance of those official controls. The Commission may in 
particular  lay down specific requirements on, among other,  the range of samples and 
the stage of production, processing and distribution at which the samples are to be 
taken , having regard to the hazards and risks related to the residues of relevant 
substances.  
Council Directive 96/23/EC  lays down  measures  for official controls of residues of 
substances having a pharmacological action, of their metabolites and of other 
substances  transmissible to animal products that are likely to be harmful to human 
health . 
The measures include  monitor ing of  those substances  and residues thereof in live 
animals and products of animal origin and  the Directive  sets specific requirements 
for Member States’ monitoring plans for the detection of residues or substances 
within its scope.  Directive  96/23/EC  was repealed by Regulation  (EU) 2017/625 with 
effect from 14 December 2019 . However, under the relevant transitional measures , 
Member States’ competent authorities shall continue to perform the necessary 
official controls in accordance with Directive 96/23/EC until 14 December 2022 . 
To ensure that after 14 December 2022,  official controls on the use of 
pharmacologically active substances authorised as veterinary medicinal products or 
as feed additives  and of prohibited or unauthorised pharmacologically active 
substances and residues  thereof  are effective and efficient , all Member States  should 
follow a sampling strategy and apply harmonised risk criteria   
The purpose of this Delegated Regulation is to supplement Article 19(1) of 
Regulation (EU) 2017/625 by laying down specific rules for the performance of 
official controls concerning  sampling for the analysis of residues of 
pharmacologically active substan ces authorized as veterinary medicines or as feed 
additives  and of prohibited or unauthorised pharmacologically active substances and 
residues thereof.  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
Member State experts were consulted within the Commiss ion Expert Group on 
Residues of Veterinary Medicines  (1), which met to discuss the subject on 10 June 
2022. 
The Delegated Regulation will maintain the existing  requirements for controls on the 
use of pharmacologically active substances authorised as veterinary medicinal 
                                                 
(1) Referenc e E03595  in the Register of Commission Expert Groups and other similar entities.   
EN 2  EN products or as feed additives and o f prohibited or unauthorised pharmacologically 
active substances and residues thereof . 
As th is Delegated Regulation maintains t he existing requirements, n o impact 
assessment  is needed and none  has been carried out .  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The legal basis for the Delegated Regulation is Article 19(2)(a) of Regulation (EU) 
2017/625.   
EN 3  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
supplementing Regulation (EU) 2017/625 of the European Parliament and of the 
Council with specific requirements for the performance of official controls on the use of 
pharmacologic ally active substances authorised as veterinary medicinal products or as 
feed additives and of prohibited or unauthorised pharmacologically active substances 
and residues thereof  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treat y on the Functioning of the European Union,  
Having regard to Regulation (EU) 2017/625 of the European Parliament and the Council of 
15 March 2017 on official controls and other official activities performed to ensure the 
application of food and feed law, r ules on animal health and welfare, plant health and plant 
protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) 
No 1069/2009, (EC) 1107/2009, (EU) 1151/2012, (EU) No 652/2014, (EU) 2016/429 and 
(EU) 2016/2031 of the European Pa rliament and of the Council, Council Regulations (EC) 
No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 
2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 
and (EC) No 882/2004 of the European Parl iament and of the Council, Council Directives 
89/608/EEC, 89/662/EEC, 60/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and 
Council Decision 92/438/EEC (Official Controls Regulation)  (2), an d in particular Article  
19(2), point  (a), thereof,  
Whereas:  
(1) Regulation (EU) 2017/625 lays down rules for the performance of official controls and 
other official activities by the competent authorities of the Member States to verify 
compliance with Union legislation in the area of food and f eed safety. In particular , 
Article 9 of that Regulation requires competent authorities to perform official controls 
on all operators regularly, on a risk basis and with an appropriate frequency. Article 
109 of that Regulation oblig es Member States to ensure that  official  controls are 
performed by the competent authorities on the basis of a multi -annual national control 
plan (‘MANCP’). Regulation (EU) 2017/625 furthermore specifies the general content 
of the MANCP , including the requir ement for  Member  States to provide in their 
MANCP  official controls on the use of pharmacologically active substances authorised 
as veterinary medicinal products or as feed additives and of prohibited or unauthorised 
pharmacologically active substances and residues thereo f. Regulation (EU) 2017/625  
empowers the Commission to lay down specific requirements for the performance of  
those  official controls, including , where appropriate, the range of samples and the 
stage of production, processing and distribution where  the samp les have to be taken, 
having regard to the hazards and risks related to the substances referred to in Article 
19(1) of that Regulation.  
                                                 
(2) OJ L 95, 7.4.2017, p. 1.   
EN 4  EN (2) Regulation (EU) 2017/625 repeal ed Council Directive 96/23/EC  (3) with effect from 
14 December 2019  and lays down the  relevant  transitional measures . Those 
transitional measures provide that, until 14 December 2022,  competent authorities are 
to continue to perform the official controls necessary in accordance with Directive 
96/23/EC  to detect the presence of certain  substanc es and groups of residues . 
Specifically, the transitory measures set  requirements for Member States’ monitoring 
plans for the detection of residues or substances within its scop e. 
(3) This Regulation ensur es the  continuity of the rules laid down in  Directive 9 6/23/EC 
concerning official controls of residues of substances having a pharmacological action, 
of their metabolites and of other substances  transmi ssible to animal products that are 
likely to be harmful to human health.  
(4) This Regulation sets rules for  the range of samples and the stage of production, 
processing and distribution at which  the samples are to be taken as regards the use of 
pharmacologically active substances authorised as veterinary medicinal products or as 
feed additives and o f prohibited  or unauthorised pha rmacologically active substances 
and residues there of. 
(5) In order to ensure that controls are effectively target ed in all Member States, it is 
appropriate to set out rules on the combination s of substance groups and commodit y 
groups  to be  sampled by Member States and the sampling strategy , including criteria 
to defin e the content of national risk -based plans and randomised surveillance plan s 
and the performance of the related official controls .  
(6) Commissio n Implementing Regulation (EU) C(20 22) 4401  (4) [Publication office 
please add here the number of this Regulation once it is associated, along the whole 
Regulation ] lays down the uniform practical arrangements for the performance of 
official controls as regards the use of pharmacologically active substances authorised 
as veterinary medicinal products or as feed additives and of prohibited or unauthorised 
pharmacolog ically active substances and residues thereof and also specifies the 
content and arrangements of the MANCP as regards these  substances and residues  
(7) Articles 4, 5 and 6 of Implementing Regulation (EU) C(2022) 4401  specify  the content 
of national risk -based plans and randomised surveillance plan focused on official 
controls on the use of pharmacologically active substances authorised as veterinary 
medicinal products or as feed additives and of prohibited or unauthorised 
pharmacologically active substances and  residues thereof . These plans should contain, 
inter alia , the list of combinations of substances and species, products and matrices 
which are included in the control plans  for which t he rules for that selection are 
defined in this Delegated Regulation. Me mber States should include in their national 
plans also sampling strategy for which criteria mentioned in this Delegated Regulation 
should be taken into account.   
(8) As the rules laid down in the Annexes to Directive 96/23/EC on measures to monitor 
certain su bstances and residues thereof in live animals and products of animal origin 
                                                 
(3) Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues 
thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and 
Decisions 89/187/EEC and 91/664/EEC (OJ L 125, 23.5.1996, p.  10). 
(4) Commission Implementing Regulation (EU) C(2022) 4401 on uniform practical arrangements for the 
performance of official con trols as regards the use of pharmacologically active substances authorised as 
veterinary medicinal products or as feed additives and of prohibited or unauthorised pharmacologically 
active substances and residues thereof, on specific content of multi -annual  national control plans and 
specific arrangements for their preparation.   
EN 5  EN are to be applied until 14 December 2022, this Regulation should apply from 15 
December  2022 , 
HAS ADOPTED THIS REGULATION:  
Article 1 
For the purposes of this Regulation, the definitions  laid down  in Regulation (EC) No 
178/2002  of the European Parliament and of the Council  (5), Commission Delegated 
Regulation (EU) 2019/2090  (6) and Commission Implementing Regulation (EU) 2021/808  (7) 
apply.  
In addition, t he following definitio ns apply:  
(1) ‘official sample’ mean s a sample taken by the competent authority, which bears, for 
the purposes of examination of the residues or substances listed in Annex I, a 
reference to the species, the type, the quantity concerned, the method of coll ection 
and particulars identifying the sex of the animal and the origin of the animal or of the 
product of animal origin, as applicable.  
(2) ‘targeted sampling ’ mean s taking official sample  or samples  with the aim of 
maximising the possibility of detecting  non-compliance with maximum residue 
limit s or maximum levels , established under Union legislation for pharmacologically 
active substances.  
(3) ‘random sampling ’ mean s the taking of an official sample or samples under 
statistical consideration to provide r epresentative data   
(4) ‘suspect sampling ’ mean s taking official samples as a follow -up to non -compliant 
control results or as the follow -up to any suspected or established non -compliance 
with Union rules on pharmacologically active substances, as laid dow n in Regulation 
(EU) 2019/2090.  
(5) ‘matrix’ mean s the material from which a sample is taken , including  animal body 
parts, fluids, excrements, tissues, products of animal origin, animal by -products, 
animal feed and water.   
(6) ‘food -producing animals’ means animals bred, raised, kept, slaughtered or harvested 
for the purposes of producing food.  
(7) ‘residue’ mean s a residue of substances having a pharmacological action, of 
metabolites of such substances, degradation products of such substances and of other 
related substances present in animals or products of animal origin.  
                                                 
(5) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 
down the general principles and requirements of food law, establishing the Euro pean Food Safety 
Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).  
(6) Commission Delegated Regulation  (EU) 2019/ 2090  of 19 June 2019 supplementing Regulation (EU) 
2017/625 of the European Parliament and Council reg arding cases of suspected or established non -
compliance with Union rules applicable to the use or residues of pharmacologically active substances 
authorised in veterinary medicinal products or as feed additives or with Union rules applicable to the 
use or residues of prohibited or unauthorised pharmacologically active substances (OJ L 317, 
9.12.2019, p. 28 ). 
(7) Commission Implementing Regulation (EU) 2021/808 of 22 March 2021 on the performance of 
analytical methods for residues of pharmacologically active  substances used in food -producing animals 
and on the interpretation of results as well as on the methods to be used for sampling and repealing 
Decisions 2002/657/EC and 98/179/EC  (OJ L 180, 21.5.2021, p. 84 ).  
EN 6  EN Article 2 
1. Member States shall control the use of pharmacologically active substances 
authorised as veterinary medicinal products or as feed additives and the presence of 
prohibited or unauthorised pharmacologically active substances and residues thereof 
listed  in Annex I.  
2. For national risk -based control plan s for production in the Member States , as 
specified  in Article 4 of Implementing Regulation (EU) C(2022) 4401 , Member 
States shall control combinations of substance groups and commodity groups in 
accordance with Annex II  to this Regulation and they shall adopt a sampling strategy 
in accordance with the criteria set out in Annex III  to this Regulation . 
3. For national randomised surveillance plan s for production in the Member States , as 
specified  in Article 5 of Implementing Regulation (EU) C(2022) 4401 , Member 
States shall control combinations of substance groups and commodity groups in 
accordance with A nnex IV  to this Regulation  and they shall adopt a sampling 
strategy in accordance with the criteria set out in Annex V  to this Regulation .  
4. For national risk -based control plan s for third country imports , as specified  in Article 
6 of Implementing Regula tion (EU) C(2022) 4401 , Member States shall control 
combinations of substance groups and commodity groups in accordance  with Annex 
VI to this Regulation and they shall adopt a sampling strategy in accordance with the 
criteria set out in Annex VII  to this R egulation . 
Article 3 
References to Annexes II and III to Directive 96/23/EC shall be construed as references to this 
Regulation.  
Article 4 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
It shall apply from 15 December 2022.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN