EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10218/2022 CIS 
(POOL/E2/2022/10218/10218 -EN 
CIS.docx)  
[…](2022) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
on 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 pharmacologically 
active  substances and residues thereof, on specific content of multi -annual national 
control plans and specific arrangements for their preparation  
(Text with EEA relevance)    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
on 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 pharmacologically 
active substances and residues thereof, on specific content of multi -annual national 
control pla ns and specific arrangements for their preparation  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty 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, rules on animal health and welfare, plant health and plant 
protection products, amending Regulations (EC) No 999/2001, (EC) No 39 6/2005, (EC) 
No 1069/2009, (EC) 1107/2009, (EU) 1151/2012, (EU) No 652/2014, (EU) 2016/429 and 
(EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) 
No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/E C, 
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 Parliament 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 an d 
Council Decision 92/438/EEC (Official Controls Regulation)  (1), and in particular Article 
19(3) , point s (a) and (b) , 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 require ment  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 thereof . Regulation (EU) 2017/625  
empowers the Commission to lay down specific additional content of the MANCP  and 
specific additional arrangements for its preparation,  as well as a uniform minimum 
frequency of official controls , having regard to the hazar ds and risks related to 
substances referred to in Article 19(1) of that Regulation .  
                                                 
(1) OJ L 95, 7.4.2017, p. 1.   
EN 2  EN (2) Regulation (EU) 2017/625 repeal ed Council Directive 96/23/EC  (2) with effect from 
14 December 2019 and lays down the relevant transitional measures. Th ose 
transitional  measures provide that, until 14 December 2022, competent authorities are 
to continue to perform official controls necessary in accordance with Directive 
96/23/EC to detect the presence of  certain substances and groups of residues. 
Specifically, the transitory  measures set requirements for Member States’ monitoring 
plans for the detection of residues or substances within its scope.  
(3) This Regulation ensur es the continuity of the rules laid down in Directive 96/23/EC 
concerning the content of the MANCP and its pre paration, as well as the minimum 
frequency of official controls, as regards  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 har mful to human health . 
(4) Regulation (EU) 2019/6  of the European Parliament and the Council  (3) establishes the 
regulatory framework for the placing on the market, manufacturing, import, export, 
supply, distribution, pharmacovigilance, control and the use of v eterinary medicinal 
products.  Furthermore, pharmacologically active substances, which are not authorised 
in veterinary medicinal products, may not be used in food -producing animals in the 
EU, with the exception of substances that are essential for the tre atment of equine 
animals as provided for in Regulation (EC) No 1950/2006  (4). 
(5) Member States are required to include 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  in 
both food -producing animals and in products of animal origin in their MANCPs. In 
order to ensure harmonis ed and effective controls among Member State s to combat the 
illegal use of growth and productivity promoters in kept animals in all Member States, 
uniform practical arrangements for the MANCPs should be further defined.  
(6) In order to verify compliance with Union legislation on the use of pharmacologically 
active substan ces authorised as veterinary medicinal products or as feed additives and 
of prohibited or unauthorised pharmacologically active substances and residues 
thereof , Member States shall carry out risk -based controls on food -producing animals 
and products of ani mal origin, produced in Member States or entering the Union from 
third countries. Th ose controls shall be included in each Member State’s MANCP and 
comprise three plans: a risk -based control plan for production in the Member State, a 
risk-based control pla n for third country imports, and, in order to collect information 
useful to orientate future risk -based controls for production in the Member States, 
Member States should include a randomised surveillance plan.  
(7) Commission Delegated Regulation (EU) C(2022)  4400  (5) [Publication office please 
add here the number of this Regulation once it is associated, along the whole 
                                                 
(2) 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). 
(3) Regulation (EU) 2019/6 of the European Parliament and the Council of 11 December 2018 on 
veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43).  
(4) Commission Regulation (EC) No 1950/2006 of 13 December 2006 establishin g, in accordance with 
Directive 2001/82/EC of the European Parliament and of the Council on the Comm unity code relating 
to veterinary medicinal products, a list of substances essential for the treatment of equidae  (OJ L 367, 
22.12.2006, p. 33 ). 
(5) Commission Delegated Regulation (EU) C(2022) 4400  of xxxx supplementing Regulation (EU) 
2017/625 of the Eur opean Parliament and of the Council with specific requirements for the performance  
EN 3  EN Regulation ] lays down rules for the performance of official controls as regards 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 of prohibited or 
unauthorised pharmacologically active substances and resid ues thereof . 
(8) Both the sampling strategy and risk criteria for defining the content of the risk-based 
control plan for production in the Member State should be set in accordance with 
Delegated Regulation (EU) C(2022) 4400  and a justification should be inclu ded in th at 
plan regarding the implementation of the risk criteria. Where, in the course of the 
execution of this control plan during a specific year, new information becomes 
available on illegal treatments, for example through the surveillance plan, Membe r 
States should update the risk-based control plan for production in the Member State 
without delay in order to ensure responsible use of pharmacologically active 
substances and a high level of human health protection. In order to guarantee a 
uniform minimum frequency of controls, this Regulation should define minimum 
control frequencies to be included in the MANCP.  
(9) Member States shall also include in their MANCPs a dedicated surveillance plan, 
based on random sampling and testing for a wide range of pharmacologically active 
substances authorised as veterinary medicinal products or as feed additives and of 
prohibited or unauthorised pharmacologically active substances and residues  thereof 
which might not be included in the risk -based national plans.  
(10) For the surveillance plan, it is appropriate that about 8  000 samples across the Union 
are taken . The controls and the associated sampling should be apportioned across the 
Member State s. Th ose minimum sampling frequencies should be included in the 
MANCP.  
(11) In order to ensure that the results obtained under the surveillance plan are comparable, 
this plan  should specify the type of analytical methods to be used and the  method 
requirements. For the surveillance plan for prohibited and unauthorised substances, in 
addition to confirmatory analytical methods, targeted and non-targeted screening 
methods are effective to identify unexpected illegal uses of authorised, prohibited and 
unauthorised p harmacologically active substances. For the surveillance plan for 
authorised substances, screening or confirmatory analytical methods capable of 
quantifying residues below the maximum residue lim it (‘MRL ’) should be used and 
the concentrations which are qu antified below the MRL should be reported in addition 
to those at or above the MRL.  
(12) In addition to controls on Member States’ production, Member States should include a 
control plan for products, which  are intended for the entry into the Union from third 
countr ies in their MANCP in order to verify the effectiveness of third countries’ 
residue controls and the compliance of imported products of animal origin with the 
Union rules. In order to guarantee a uniform minimum frequency of the controls 
carried out under the plan  for third country imports and to ensure that they are carried 
out at least at a frequency which is equal to the control frequency for risk-based 
control pl an for production in Member States , this Regulation should define the 
minimum frequencies for th ose controls to be applied by Member States, through 
whose border control posts  the animals and products of animal origin enter the Union.  
                                                                                                                                                         
of official controls on the use of pharmacologically active substances authorised as veterinary medicinal 
products or as feed additives and on prohibited or unauthorised pha rmacologically active substances 
and residues thereof .  
EN 4  EN (13) In order to ensure a  harmonised and comprehensive content of the MANCP on the use 
of pharmacologically active substances authorised as veterinary medicinal products or 
as feed additives and of prohibited or unauthorised pharmacologically active 
substances in food -producing an imals and residues thereof in animals and animal 
products, the relevant aspects of its content should be defined.  
(14) Sampling procedures, handling and transport conditions have an influence on the 
ability to detect the presence of residues of pharmacologicall y active substances 
authorised as veterinary medicinal products or as feed additives and of prohibited or 
unauthorised pharmacologically active substances and residues thereof in samples. 
Therefore, Member States should follow the rules laid down in  Commis sion 
Implementing Regulation (EU) 2021/808  (6).  
(15) It is necessary to ensure that the analytical results gathered under the control plans for 
pharmacologically active substances authorised as veterinary medicinal products or as 
feed additives and of prohibit ed or unauthorised pharmacologically active substances 
and residues thereof  and the interpretation of the results  are comparable . Therefore, the 
plans should describe the analytical methods to be used as well as their performance 
requirements, in accordanc e with the provisions of Implementing Regulation (EU) 
2021/808.  
(16) In order to ensure that Member States’ risk -based control plans for both Union 
production and for third country imports, as well as their surveillance plans for 
production in the Member State s, comply with this Regulation, Member States should 
submit these control plans to the Commission  for evaluation annual ly . The 
Commission should communicate its comments to the Member States  if needed . 
Member States should prepare a revised and updated pl an incorporating the comments 
no later than 31 March of the following year. However, where the Commission 
considers that the plans would impair the effectiveness of official controls , it should be 
able to request the Member State to submit an updated plan addressing  the 
Commission’s comments at an earlier date.  
(17) In accordance with Article 33 of Regulation (EC) No 178/2002  of the Europea n 
Parliament and of the Council  (7), the data collected by the Member States through 
official controls in respect of residu es of 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 
must  be submitted to the European Food Safety A uthority (‘EFSA’) .  In order to allow 
for the monitoring of recent data, all Member States should submit data on a regular 
basis and by the same date.  
(18) Commission Decision 97/747/EC  (8), fixing levels and frequencies of sampling in 
addition to those provided for in the Annexes to Directive 96/23/EC, should be 
repealed as its provisions are replaced by the provisions of  this Regulation.  
                                                 
(6) 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) . 
(7) 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 European Food Safety 
Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).  
(8) 97/747/EC : Commission Decision of 27 October 1997 fixing the levels and frequencies of sampling 
provided for by Council Directive 96/23/EC for the monitoring of certain substances and residues 
thereof in certain animal products (OJ L 303, 6.11.1997, p. 12).   
EN 5  EN (19) As the rules laid down in the Annexes to Directive  96/23/EC on measures to monitor 
certain substances and residues thereof in live animals and products of animal origin 
are to be applied until  14 December 2022, this Regulation should apply from 15 
December 2022 . 
(20) The measures provided for in this Regulatio n are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
 
CHAPTER I  
Subject matter, scope and definitions  
Article 1  
Subject matter   
For the purpose 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 , this Regulat ion lays 
down [the following :  
(a) the annual uniform minimum sampling frequency as part of official controls, having 
regard to the hazards and risks related to the substances concerned ;  
(b) specific additional arrangements and specific additional content for the Member 
States’ multi -annua l national control plan (‘ MANCP ’), in addition to those provided 
for in Article 110 of Regulation (EU) 2017/625 .  
 
Article 2  
Definitions  
For the purposes of this Regulation, the definitions in Regulation (EC) No 178/2002,  
Delega ted Regulation (EU) 2019/2090  (9), Implementing Regulation (EU) 2021/808  and 
Delegated  Regulation (EU) C(2022) 4400  apply.  
                                                 
(9)  Commission Delegated Regulation (EU) 2019/2090 of 19 June 2019 supplementing Regulation (EU) 
2017/625 of the European Parliament and Council regarding cases of suspected or established non -
compliance with Union rules applicable to the use or residues of pharmacologically active substances 
authorised in ve terinary 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).   
EN 6  EN CHAPTER II  
Specific additional content of the MANCP  
Article 3  
General provisions  
Member States shall ensure that the part of the MANCP concerning the performance of 
official controls on the use of pharmacologically active substances authorised as veterinary 
medicinal products or as feed additives and the presence of prohibited or unaut horised 
pharmacologically active substances  and residues thereof in live animals and animal products 
contains the following:  
(a) a ‘national risk -based control plan for production in the Member States ’, as set out in 
Article 4;  
(b) a ‘national randomised surveillance plan for production in the Member States ’ as set 
out in Article 5  
 (c) a ‘national risk -based control plan for third country imports ’ as set out in Article 6.   
Article 4  
National risk -based control plan for production in the Member States  
Member States shall prepare a national risk -based control plan for substance s in groups A and 
B of Annex I to Delegated Regulation (EU) C(2022) 4400  to verify compliance of food -
producing animals and products of animal origin produced in the Member States  with Union 
legislation governing 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 and the applicable maximum residue limits (‘ MRL ’) 
and maximum levels (‘ML’) in food.  
The national risk -based control plan for production in the Member States shall contain  the 
following :  
(a) the list of combinations of substances and species, products and matrices in 
accor dance with Annex I I to Delegated Regulation (EU)  C(2022) 4400 ; 
(b) the sampling strategy as decided by the Member State in accordance with Annex III 
to Delegated Regulation (EU) C(2022) 4400 ; 
(c) the actual  sampling frequencies  as decided by the Member State taking into account 
the annual minimum control frequencies laid down in Annex I ;  
(d) the analytical methods to be used and their performance characteristics ; 
(e)  the detailed information referred to in Article 7(1) and (2).  
Pursuant to Article 111(2) of Regulation (EU) 2017/625, during the course of the execution of 
the MANCP, Member States  shall review  the national risk -based plan for production in the 
Member States to take account of illegal treatments identified, in particul ar, through the 
surveillance plan .   
EN 7  EN Article 5  
National randomised surveillance  plan for production in the Member States  
Member States shall prepare a national randomised surveillance plan for the control of 
production in the Member States , ensuring random monitoring for a wide range of substances.  
The national randomised surveillance plan for production in each Member State shall  contain  
the following : 
(a) the list of combinations of substances and species, products and matrices in 
accordan ce with Annex I V to Delegated Regulation (EU)  C(2022) 4400 ;  
(b) the sampling strategy as decided by the Member State set out in accordance with 
Annex V to Delegated Regulation  (EU)  C(2022) 4400 ;  
(c) the actual sampling frequencies as decided by the Member State taking into account 
the minimum sampling frequencies prescribed in Annex II to this Regulation ; 
(d) the detailed information referred  to in Article  7(1). 
In accordance with the requirements for methods of analysis provided for i n Implementing 
Regulation (EU) 2021/808, Member State shall use analytical methods for the analysis of 
pharmacologically active substances authorised as veterinary medicinal products or as feed 
additives and of prohibited or unauthorised pharmacologically active substances and residues 
thereof in products of animal origin, which provide quantitative or semi -quantitative results, 
including when these residues are identified and quantified at levels below the MRL .  
Member States shall in clude reporting r equir ements for the controls on the use of authorised 
substances , which ensure the reporting of all concentrations at or above the detection 
capability for screening  (‘CCβ’) of the method, while ensuring that the lowest CCβ , which is 
reasonably achievable, is o btained for the methods, which  are used to perform the screening 
analyses . For testing carried out with confirmatory methods only, all quantif iable results shall 
be reported . In case of use of targeted and non-targeted screening methods, Member States 
shall report on the use and the findings of these analytical methods .  
Article 6  
National risk -based control plan for third country imports  
Member States shall prepare a national risk -based control plan for food -producing animals 
and product s of animal origin entering into the Union  and intended for placing  on the U nion 
market through their border control posts (‘BCP’) and other points of entry  such as on vessels 
according to Commission Implementing Regulation (EU) 2019/627  (10) to verify comp liance 
with Union legislation on the use of pharmacologically active substances  as listed in Annex I 
to Delegated Regulation (EU) C(2022) 4400  and compliance with applicable MRLs  and MLs .  
Controls on the use of pharmacologically active substances authoris ed as veterinary medicinal 
products or as feed additives and of prohibited or unauthorised pharmacologically active 
substances and residues thereof shall be carried out as part of the  official controls at BCP  
provided for in Article 47 and Article 65 of Regulation (EU) 2017/625.  
                                                 
(10) Commission Implementing Regulation (EU) 2019/627 of 1 5 March 2019 laying down uniform practical 
arrangements for the performance of official controls on products of animal origin intended for human 
consumption in accordance with Regulation (EU) 2017/625 of the European Parliament and of the 
Council and amend ing Commission Regulation (EC) No 2074/2005 as regards official controls  (OJ L 
131, 17.5.2019, p. 51 ).  
EN 8  EN The national risk -based control plan for third country imports shall contain  the following : 
(a) the list of combinations of substances and species, products and matrices in 
accordance with Annex VI to Delegated Regulation (EU) C(2022) 4400 ; 
(b) the sampling strategy as decided by the Member State in accordance with Annex VII 
to Delegated Regulation (EU) C(2022) 4400 ;  
(c) the actual sampling frequencies for controls carried out at BCP  as decided by the 
Member State taking into acc ount the annual minimum sampling frequencies in 
accordance with Annex III to this Regulation . The samples taken for the purpose of  
official controls carried out pursuant to Article 65(1), (2) and (4) of Regulation (EU) 
2017/625 , shall, however, not be considered as samples contributing  to reach the 
minimum  sampling frequencies of Annex I II of this Regulation ;  
(d) the analytical methods to be used and their performance characteristics ; 
(e) the detailed information referred to in Article 7(1) and (2) . 
Article 7  
Additional content of the national risk -based control plans and randomised surveillance 
plan  
1. The national risk -based control plans , referred to in Articles 4 and 6 , and national  
randomised  surveillance plan , referred to in Article 5 , shall specify  the following  
information :  
(a) the details on species to be sampled and on place of sampling ;  
(b) information on the national legislation  on the use of  pharmacologically active 
substances and, in particular, on their prohibition or authorisation, distribution 
and placing on the market and the rules governing their administration, in so 
far as suc h legislation is not harmonised;  
(c) information about  the competent authorities responsible for the implementation 
of the plans ;  
(d) the type of follow -up measures taken by the competent authorities with regard 
to animals or products of animal origin in which non -compliant residues have 
been detected in the previous years   
2. The national risk based control plans referred to i n Articles 4 an d 6 shall, in addition 
to the information specified in paragraph 1, provide  the following : 
(a) a justification for the selected substances, species, products and matrices 
included in the plans on the basis of the criteria listed in Annexes I I and V I to 
Delegated Regulation (EU) C(2022) 4400 , including a justification on how the 
criteria listed in th ose Annexes were taken into account, even if no changes 
were made compared t o the plan of the previous year;  
(b) a justification on how information from an over view of the non -compliances in 
the relevant Member State of the previous three  calendar years provided  by 
EFSA was tak en into account for optimising the plan.  
Member States do not need submit information already provided in the general part of the 
MANCP or  described in U nion legislation according to Article 110(2) of Regulation (EU) 
2017/625 .  
EN 9  EN CHAPTER III  
Submission and evaluation of the plans and submission of data by the 
Member States  
Article 8  
Submission and evaluation of the control plans   
By 31 March of  each year, Member States shall submit , in an agreed [by who] format,  revised 
and updated national risk -based control plans and randomised surveillance plan for the current 
calendar year to the Commission electronically .  
The Commission shall evaluate those plans on the basis of this Regulation and Delegated 
Regulation (EU) C(2022) 4400  and shall communicate its evaluation together with comments 
or recommendations, where needed, to each Member State within 4 months of receipt of the 
plans .  
Member States shall provide the Commission with updated versions of the respective plans, 
outlining how the Commission’s comments have been taken into account , at the latest by 31 
March of the following year. Where a Member State decides not to update its control plans 
based on the Commission’s comments, it shall justify its position.  
Where the Commission considers  that the plans would impair the effectiveness of official 
controls, updated versions of the concerned plans shall be submitted earlier upon request  of, 
and within a reasonable  time period set by the Commission.   
Article 9  
Submission of data by the Member State  
By 30 June  of each year , Member States shall trans mit to EFSA all data from the previous 
year, including compliant results of screenin g methods where no confirmatory analyses were 
performed , gathered under the control plans referred to in Article 3 .  
By 31 August each year , the data validation, review and final acceptance in EFSA data 
repository systems shall be finalised by each Member State.  
 
CHAPTER IV   
General provisions  
Article 10  
Repeal  of Decision 97/747/EC  
Decision 97/747/EC is hereby repealed.  
Article 11  
References   
EN 10  EN References to Articles 3, 4, 5, 6, 7 and 8 of Directive 96/23/EC and Annexes I  and IV to that  
Directive and to Decision 97/747/EC shall be construed as references to this Regulation.  
Article 12  
Entry into force and application  
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 B russels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN