COMMISSION IMPLEMENTING REGUL ATION (EU) 2022/1646 
of 23 September 2022
on unifor m practical arrangements for the perfor mance of official controls as regards the use of 
phar macologically activ e subs tances author ised as veter inar y medicinal products or as feed additiv es 
and of prohibited or unauthor ised phar macologically activ e subst ances and residues thereof, on 
specif ic content of multi-annual national control plans and specif ic arrangements for their 
preparation 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng regar d to Regulation (EU) 2017/625 of the European Parliament and the Council of 15 March 2017 on official 
controls and other official activities perf ormed to ensure the application of food and feed law, rules on animal health and 
welf are, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) 
No 1069/2009, (EC) No 1107/2009, (EU) No 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/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 Parliament and of the Council, Council Directives 89/608/EEC, 
89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Offici al 
Controls Regulation) (1), and in particular Article 19(3), points (a) and (b), thereof,
Whereas:
(1) Regulation (EU) 2017/625 lays down rules for the perf ormance of official controls and other official activities by the 
compet ent author ities of the Member States to verify compl iance with Union legislation in the area of food and feed 
safety . In particular , Article 9 of that Regulation requires compe tent author ities to perf orm official controls on all 
operat ors regularly , on a risk basis and with an appropr iate frequency . Article 109 of that Regulation oblig es 
Member States to ensure that official controls are performed by the compet ent author ities on the basis of a multi- 
annual national control plan (‘MANCP’). Regulation (EU) 2017/625 further more specifies the general conte nt of the 
MANCP , including the requirement for Member States to provide in their MANCP official controls on the use of 
phar macologically active substances author ised as veteri nary medicinal products or as feed additives and of 
prohibit ed or unauthor ised phar macologically active substances and residues thereof. Regulation (EU) 2017/625 
empo wers the Commission to lay down specifi c additional cont ent of the MANCP and specifi c additional 
arrange ments for its preparation, as well as a unif orm minimum frequency of official controls, having regard to the 
hazards and risks related to substances refer red to in Article 19(1) of that Regulation.
(2) Regulation (EU) 2017/625 repealed Council Directive 96/23/EC (2)with effect from 14 December 2019 and lays 
down the relevant transitional measures. Those transitional measures provid e that, until 14 December 2022 , 
compet ent author ities are to continue to perform official controls necessar y in accordance with Directive 96/23/EC 
to detect the presence of certain substances and groups of residues. Specific ally, the transito ry measures set 
requirements for Member States’ monitori ng plans for the detection of residues or substances within its scope.
(3) This Regulation ensures the continuity of the rules laid down in Directive 96/23/EC concer ning the conte nt of the 
MANCP and its preparation, as well as the minimum frequency of official controls, as regar ds official controls of 
residues of substances having a phar macological action, of their metabolites and of other substances transmissible 
to animal products that are likely to be harmful to human health.
(1)OJ L 95, 7.4.2017, p. 1.
(2)Council Directive 96/23/EC of 29 Apr il 1996 on measures to monit or 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).EN Offi cial Jour nal of the European Union L 248/32 26.9.2022  (4) Regulation (EU) 2019/6 of the European Parliament and the Council (3)establishes the regulator y framew ork for the 
placing on the mark et, manuf actur ing, impor t, expor t, supply , distr ibution, phar macov igilance, control and the use 
of veteri nary medicinal products. Further more, phar macologically active substances, which are not author ised in 
veteri nary medicinal products, may not be used in food-producing animals in the EU, with the excep tion of 
substances that are essential for the treatment of equine animals as provided for in Commission Regulation (EC) 
No 1950/2006 (4).
(5) Member States are required to include controls on the use of phar macologically active substances author ised as 
veteri nary medicinal products or as feed additives and of prohibit ed or unauthor ised phar macologically active 
substances and residues thereof in both food-producing animals and in products of animal origin in their MANCPs. 
In order to ensure harmonised and effective controls among Member State s to combat the illegal use of growth and 
productivity promote rs in kept animals in all Member State s, unif orm practical arrangements for the MANCPs 
should be further defined.
(6) In order to verify compl iance with Union legislation on the use of phar macologically active substances author ised as 
veteri nary medicinal products or as feed additives and of prohibit ed or unauthor ised phar macologically active 
substances and residues thereof, Member States shall carry out risk-based controls on food-producing animals and 
products of animal origin, produced in Member States or entering the Union from third countr ies. Those controls 
shall be included in each Member State’s MANCP and compris e three plans: a risk-based control plan for production 
in the Member State, a risk-based control plan for third-countr y impor ts, and, in order to collect information useful 
to orientat e future risk-based controls for production in the Member State s, Member States should include a 
randomised surveillance plan.
(7) Commission Delegat ed Regulation (EU) 2022/1644 (5)lays down rules for the performa nce of official controls as 
regards the range of samples and the stage of production, processing and distr ibution at which the samples are to be 
taken as regar ds the use of phar macologically active substances author ised as vete rinar y medicinal products or as 
feed additives and of prohibited or unauthor ised phar macologically active substances and residues thereof.
(8) Both the sampling strateg y and risk criteria for defining the cont ent of the risk-based control plan for production in 
the Member State should be set in accordance with Delegat ed Regulation (EU) 2022/1644 and a justif ication should 
be included in that plan rega rding the implementation of the risk criteria. Where, in the course of the executi on of 
this control plan during a specifi c year, new information becomes available on illegal treatments, for example 
through the surveillance plan, Member States should updat e the risk-based control plan for production in the 
Member State without dela y in order to ensure responsible use of phar macologically active substances and a high 
level of human health prote ction. In order to guarantee a unif orm 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 dedicate d surveillance plan, based on random sampling and 
testing for a wide range of phar macologically active substances author ised as veteri nary medicinal products or as 
feed additives and of prohibited or unauthor ised phar macologically active substances and residues thereof whic h 
might not be included in the risk-based national plans.
(3)Regulation (EU) 2019/6 of the European Parliament and the Council of 11 December 2018 on veterinar y 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 establishing, in accordance with Directive 2001/82/EC of the 
European Parliament and of the Council on the Community code relating to veterin ary medicinal products, a list of substances 
essential for the treatment of equidae and of substances bringing added clinical benef it (OJ L 367, 22.12.2006, p. 33).
(5)Commission Delegat ed Regulation (EU) 2022/1644 of 7 July 2022 supplementing Regulation (EU) 2017/625 of the European 
Parliament and of the Council with specific requirements for the perfor mance of official controls on the use of phar macologically 
active substances author ised as veterin ary medicinal products or as feed additives and of prohibited or unauthor ised phar macologically 
active substances and residues thereof (see page 3 of this Offi cial Jour nal).EN Offi cial Jour nal of the European Union 26.9.2022 L 248/33  (10) For the surveillance plan, it is appropr iate that about 8 000 sample s across the Union are taken. The controls and the 
associated sampling should be appor tioned across the Member States. Those minimum sam pling 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 
unauthor ised substances, in addition to confir matory methods, target ed and non-target ed screening methods are 
effective to identify unexpected illegal uses of author ised, prohibit ed and unauthor ised phar macologically active 
substances. For the surveillance plan for author ised substances, screening or conf irmatory methods capable of 
quantifying residues below the maximum residue limit (‘MRL ’) should be used and the concentrations which are 
quantifi ed below the MRL should be repor ted 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 entr y into the Union from third countr ies in their MANCP in order to verify the 
effectiveness of third countr ies’ residue controls and the compl iance of impor ted products of animal origin with the 
Union rules. In order to guarant ee a unif orm minimum frequency of the controls carried out under the plan for 
third-countr y impor ts and to ensure that they are carried out at least at a frequency whic h is equal to the control 
frequency for risk-based control plan for production in Member States, this Regulation should define the minimum 
frequencies for those controls to be applied by Member States, through whose border control posts the animals and 
products of animal origin enter the Union.
(13) In order to ensure a harmonised and comprehensive content of the MANCP on the use of phar macologically active 
substances author ised as veterinar y medicinal products or as feed additives and of prohibited or unauthor ised 
phar macologically active substances in food-producing animals and residues thereof in animals and products of 
animal origin, the relevant aspects of its content should be defined .
(14) Sampli ng procedures, handling and transpor t conditions have an influence on the ability to detec t the presence of 
phar macologically active substances author ised as veteri nary medicinal products or as feed additives and of 
prohibit ed or unauthor ised phar macologically active substances and residues thereof in sam ples. Theref ore, 
Member States should follow the rules laid down in Commission Imp lementing Regulation (EU) 2021/808 (6).
(15) It is necessar y to ensure that the analytical results gathered under the control plans as regar ds the use of 
phar macologically active substances author ised as veteri nary medicinal products or as feed additives and of 
prohibit ed or unauthor ised phar macologically active substances and residues thereof and the interpr etation of the 
results are comparable. Theref ore, the plans should descr ibe the analytical methods to be used as well as their 
performa nce requirements, in accordance with the provi sions 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-countr y 
imp orts, as well as their surveillance plans for production in the Member State s, compl y with this Regulation, 
Member State s should submit these control plans to the Commission for evaluation annually . The Commission 
should communicate its comments to the Member States if needed. Member States should prepare a revised and 
update d plan incor porating 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.
(6)Commission Implementing Regulation (EU) 2021/808 of 22 March 2021 on the performance of analytical methods for residues of 
phar macologically active substances used in food-producing animals and on the inter pretation of results as well as on the methods to 
be used for sampli ng and repealing Decisions 2002/657/EC and 98/179/EC (OJ L 180, 21.5.2021, p. 84).EN Offi cial Jour nal of the European Union L 248/34 26.9.2022  (17) In accordance with Article 33 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (7), 
the data collected by the Member State s through official controls in respect of the use of phar macologically active 
substances author ised as veterinar y medicinal products or as feed additives and of prohibited or unauthor ised 
phar macologically active substances and residues thereof must be submitted to the European Food Safet y Author ity 
(‘EFSA ’). In order to allow for the monitori ng 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 Annex es to Directive 96/23/EC, should be repealed as its provis ions are replaced by the provisions of this 
Regulation.
(19) As the rules laid down in the Annex es 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 provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGUL ATION:
CHA PTER I
SUBJECT MA TTER, SCOPE AND DEFINITIONS
Article 1
Subject matter
For the purpose of official controls on the use of phar macologically active substances author ised as veterinar y medicinal 
products or as feed additives and of prohibited or unauthor ised phar macologically active substances and residues thereof, 
this Regulation lays down the following:
(a) the annual unif orm minimum sam pling frequency as part of official controls, having regard to the hazards and risks 
related to the substances concer ned;
(b) specifi c additional arrange ments and specif ic additional content for the Member States’ multi-annual national control 
plan (‘MANCP’), in addition to those provided for in Article 110 of Regulation (EU) 2017/625.
Article 2
Def initions
For the purposes of this Regulation, the definit ions in Regulation (EC) No 178/2002, Commission Delegat ed Regulation 
(EU) 2019/2090 (9), Implementing Regulation (EU) 2021/808 and Deleg ated Regulation (EU) 2022/1644 apply .
(7)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Januar y 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 samplin g provided for by Council Directive 
96/23/EC for the monit oring of certain substances and residues thereof in certain animal products (OJ L 303, 6.11.1997, p. 12).
(9)Commission Delegat ed Regulation (EU) 2019/2090 of 19 June 2019 supplementing Regulation (EU) 2017/625 of the European 
Parliament and Council regar ding cases of suspected or established non-compliance with Union rules applicable to the use or residues 
of phar macologically active substances author ised in veterinar y medicinal products or as feed additives or with Union rules applicable 
to the use or residues of prohibited or unauthor ised phar macologically active substances (OJ L 317, 9.12.2019, p. 28).EN Offi cial Jour nal of the European Union 26.9.2022 L 248/35  CHAPTER II
SPECIFIC ADDITIONAL CONTENT OF THE MANCP
Article 3
General provisions
Member States shall ensure that the part of the MANCP concer ning the performa nce of official controls on the use of 
phar macologically active substances author ised as veteri nary medicinal products or as feed additives and of prohibited or 
unauthor ised phar macologically active substances and residues thereof in live animals and products of animal origin 
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-countr y impor ts’ 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 substances in groups A and B of Annex I to Delegat ed 
Regulation (EU) 2022/1644 to verify compl iance of food-producing animals and products of animal origin produced in 
the Member States with Union legislation governing the use of phar macologically active substances author ised as 
veteri nary medicinal products or as feed additives and of prohibit ed or unauthor ised phar macologically 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 matr ices in accordance with Annex II to Deleg ated 
Regulation (EU) 2022/1644;
(b) the sam pling strateg y as decided by the Member State in accordance with Annex III to Delega ted Regulation (EU) 2022/ 
1644;
(c) the actual sampli ng 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 perf ormance character istics;
(e) the detailed information refer red to in Article 7(1) and (2).
Pursuant to Article 111(2) of Regulation (EU) 2017/625, during the course of the execut ion of the MANCP , Member States 
shall review the national risk-based plan for production in the Member States to take account of illegal treatments 
identif ied, in particular , through the surveillance plan.
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 State s, 
ensur ing random monitori ng for a wide rang e of substances.
The national randomised surveillance plan for production in each Member State shall contain the following:EN Offi cial Jour nal of the European Union L 248/36 26.9.2022  (a) the list of combinations of substances and species, products and matr ices in accordance with Annex IV to Deleg ated 
Regulation (EU) 2022/1644;
(b) the sampli ng strategy as decided by the Member State set out in accordance with Annex V to Deleg ated Regulation (EU) 
2022/1644;
(c) the actual sam pling frequencies as decided by the Member State taking into account the minimum sampling frequencies 
prescr ibed in Annex II to this Regulation;
(d) the detailed information refer red to in Article 7(1).
In accordance with the requirements for methods of analysis provided for in Imp lementing Regulation (EU) 2021/808, 
Member State shall use analytical methods for the analysis of phar macologically active substances author ised as veterinar y 
medicinal products or as feed additives and of prohibited or unauthor ised phar macologically active substances and residues 
thereof in products of animal origin, which provide quantitative or semi-quantitative results, including when these residues 
are identif ied and quantified at levels below the MRL.
Member State s shall include repor ting requirements for the controls on the use of author ised substances, which ensure the 
repor ting of all concentrations at or abov e the detection capability for screening (‘CCβ’) of the method, while ensur ing that 
the lowe st CCβ, whic h is reasonably achievable , is obtained for the methods, which are used to perf orm the screening 
analyses. For testing carried out with confir matory methods only , all quantifi able results shall be repor ted. In case of use of 
target ed and non-target ed screening methods, Member State s shall repor t on the use and the findings of these analytical 
methods.
Article 6
National risk-based control plan for third-countr y impor ts
Member States shall prepare a national risk-based control plan for food-producing animals and products of animal origin 
entering into the Union and intended for placing on the Union market through their border control posts (‘BCP’) and other 
points of entr y such as on vessels according to Commission Imp lementing Regulation (EU) 2019/627 (10)to verify 
compl iance with Union legislation on the use of phar macologically active substances as liste d in Annex I to Deleg ated 
Regulation (EU) 2022/1644 and compl iance with applicable MRLs and MLs.
Controls on the use of phar macologically active substances author ised as veteri nary medicinal products or as feed additives 
and of prohibit ed or unauthor ised phar macologically active substances and residues thereof shall be carried out as part of 
the official controls at BCP provid ed for in Article 47 and Article 65 of Regulation (EU) 2017/625.
The national risk-based control plan for third-countr y imports shall contain the following:
(a) the list of combinations of substances and species, products and matr ices in accordance with Annex VI to Deleg ated 
Regulation (EU) 2022/1644;
(b) the sam pling strateg y as decided by the Member State in accordance with Annex VII to Delegat ed Regulation (EU) 
2022/1644;
(c) the actual sam pling frequencies for controls carried out at BCP as decided by the Member State taking into account the 
annual minimum sampli ng frequencies in accordance with Annex III to this Regulation. The samp les 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 contr ibuting to reach the minimum sampli ng frequencies of Annex III of this 
Regulation;
(10)Commission Implementing Regulation (EU) 2019/627 of 15 March 2019 laying down unif orm practical arrangements for the 
perfor mance of official controls on products of animal origin intended for human consump tion in accordance with Regulation (EU) 
2017/625 of the European Parliament and of the Council and amending Commission Regulation (EC) No 2074/2005 as regar ds 
official controls (OJ L 131, 17.5.2019, p. 51).EN Offi cial Jour nal of the European Union 26.9.2022 L 248/37  (d) the analytical methods to be used and their perf ormance character istics;
(e) the detailed information refer red 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, refer red to in Articles 4 and 6, and national randomised surveillance plan, 
refer red to in Article 5, shall specify the followi ng information:
(a) the details on species to be sampled and on place of sampling;
(b) information on the national legislation on the use of phar macologically active substances and, in particular , on their 
prohibition or author isation, distr ibution and placing on the mark et and the rules govern ing their administration, in 
so far as such legislation is not harmonised;
(c) information about the compet ent author ities responsible for the implementation of the plans;
(d) the type of follow-up measures take n by the compet ent author ities with regard to animals or products of animal origin 
in which non-com pliant residues have been detect ed in the previous years
2.The national risk based control plans refer red to in Articles 4 and 6 shall, in addition to the information specifi ed in 
paragraph 1, provid e the follo wing:
(a) a justification for the select ed substances, species, products and matr ices included in the plans on the basis of the 
criteria liste d in Annex es II and VI to Delegat ed Regulation (EU) 2022/1644, including a justif ication on how the 
criteria listed in those Annex es were taken into account, even if no chang es were made compar ed to the plan of the 
previous year;
(b) a justification on how information from an overview of the non-com pliances in the relevant Member State of the 
previous three calendar years provided by EFSA was taken into account for optimising the plan.
Member States do not need submit information already provid ed in the general part of the MANCP or descr ibed in Union 
legislation according to Article 110(2) of Regulation (EU) 2017/625.
CHA PTER III
SUBMISSION AND EVALU ATION 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 format, revised and update d 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 Delegat ed Regulation (EU) 2022/1644 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 take n into account, at the latest by 31 March of the follo wing year . Where a Member 
State decides not to update its control plans based on the Commission’s comments, it shall justify its position.EN Offi cial Jour nal of the European Union L 248/38 26.9.2022  Where the Commission considers that the plans would impair the effectiveness of official controls, updated versions of the 
concer ned plans shall be submitt ed 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 transmit to EFSA all data from the previous year , including compliant results 
of screening methods where no confir matory analyses were perf ormed, gathered under the control plans refer red to in 
Article 3.
By 31 August each year, the data validation, review and final acceptance in EFSA data reposit ory system s shall be finalised 
by each Member State .
CHA PTER IV
GENERAL PROVISIONS
Article 10
Repeal of Decision 97/747/EC
Decision 97/747/EC is hereby repealed.
Article 11
References
References to Articles 3, 4, 5, 6, 7 and 8 of Directive 96/23/EC and Annex es I and IV to that Directive and to Decision 
97/747/EC shall be constr ued as references to this Regulation.
Article 12
Entr y into force and application
This Regulation shall enter into force on the twentieth day followi ng 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, 23 Septembe r 2022 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 26.9.2022 L 248/39  ANNEX I 
Minimum sampling frequency per Member State in the national risk-based control plan for 
production in the Member States (as refer red to in Article 4(c))
The minimum number of samples is as follows:
Sampl ing frequency – Group A substances
Bovin e Minimum 0,25 % of the slaughtere d animals (minimum 25 % of the samples to be taken 
from live animals on the farm and minimum 25 % of the samples to be taken at the 
slaughterh ouse)
Sheep and goats Minimum 0,01 % of the slaughtere d animals per species
Porcine Minimum 0,02 % of the slaughtere d animals
Equine Minimum 0,02 % of the slaughtere d animals
Poultr y For each catego ry of poultr y considered (broiler chick ens, spent hens, turk eys and other 
poultr y) minimum 1 sam ple per 400 tons of annual production (deadweight)
Aquacul ture (finfish, crustaceans 
and other aquaculture products)Minimum 1 sam ple per 300 tonnes of annual production of aquaculture for the first 
60 000 tonnes of production and then 1 additional sam ple for each additional 2 000
tonnes
Bovin e, ovine and capr ine milk Minimum 1 sam ple per 30 000 tonnes of annual production of milk per species
Hen eggs and other eggs Minimum 1 sam ple per 2 000 tonnes of annual production of eggs per species
Rabbits, farmed game, reptiles 
and insectsMinimum 1 sam ple per 100 tonnes of annual production (dead weight) of rabbits, 
farmed game or reptiles for the first 3 000 tonnes of production and 1 sam ple for each 
additional 1 000 tonnes
Minimum 1 sam ple per 25 tonnes annual production of insects
Honey Minimum 1 sam ple per 50 tonnes of annual production for the first 5 000 tonnes of 
production and then 1 additional sample for each additional 500 tonnes
Casings * Minimum 1 sam ple per 300 tonnes of annual production
*As defined in Commission Delegat ed Regulation (EU) 2020/692 of 30 Januar y 2020 supplementing Regulation (EU) 2016/429 of the 
European Parliament and of the Council as regards rules for entr y into the Union, and the mov ement and handling after entr y of 
consignments of certain animals, germinal products and products of animal origin (OJ L 174, 3.6.2020, p. 379 ).
Sampling frequency – Group B substances
Bovin e Minimum 0,10 % of the slaughtere d animals
Sheep and goats Minimum 0,02 % of the slaughtere d animals per species
Porcine Minimum 0,02 % of the slaughtere d animals
Equine Minimum 0,02 % of the slaughtere d animals
Poultr y For each catego ry of poultr y considered (broiler chick ens, spent hens, turk eys and other 
poultr y) minimum 1 sam ple per 500 tonnes of annual production (deadweight)EN Offi cial Jour nal of the European Union L 248/40 26.9.2022  Sampling frequency – Group B substances
Aquacul ture (finfish, crustaceans 
and other aquaculture products)Minimum 1 sam ple per 300 tonnes of annual production of aquaculture for the first 
60 000 tonnes of production and then 1 additional sam ple for each additional 2 000
tonnes
Bovin e, ovine and capr ine milk Minimum 1 sam ple per 30 000 tonnes of annual production of milk per species
Hen eggs and other eggs Minimum 1 sam ple per 2 000 tonnes of annual production of eggs per species
Rabbits, farmed game, reptiles 
and insectsMinimum 1 sample per 50 tonnes of annual production (dead weight) of rabbits, farmed 
gam e or reptiles for the first 3 000 tonnes of production and 1 sample for each 
additional 500 tonnes
Minimum 1 sam ple per 25 tonnes annual production of insects
Honey Minimum 1 sam ple per 50 tonnes of annual production for the first 5 000 tonnes of 
production and then 1 additional sample for each additional 500 tonnes
Additional provisions
(a) If relevant to verify compl iance with Union legislation on the use of prohibit ed or unauthor ised phar macologically 
active substances, Member States may take sam ples from feed, water or another relevant matr ix or environment and 
counted towards achi eving the minimum sampli ng frequencies provi ded for in this Annex.
(b) Controls on each combination of sub-groups of Group A substances and commodity groups as listed in Annex II to 
Delegat ed Regulation (EU) 2022/1644 shall be annually performe d in minimum 5 % of the samples taken in 
accordance to the table of this Annex for that commodity group. This minimum percentage does not apply to casings 
and it does not apply to group A(3), point (f) for all commodity groups.
(c) For the Group B substances, the selection of specific substances for testing within each substance group is to be 
decided according to criteria listed in Annex II to Deleg ated Regulation (EU) 2022/1644.
(d) Within bovine, ovine and capr ine group, the sam ples shall be taken from all species, taking into account their relative 
production volume. Sampli ng shall cover both animals for dair y production and for meat production.
(e) Within the poultr y group, samples shall be taken from broiler chic kens, spent hens, turk ey and other poultr y, taking 
into account their relative production volume.
(f) Within the aquaculture group, samples shall be taken from fresh and seawater aquaculture species, taking into account 
their relative production volume.
(g) When there is a reason to believe that phar macologically active substances are being applied to the other aquaculture 
products, then these species must be included in the sampli ng plan in propor tion to their production as additional 
samples to those take n for finfish farming products.
(h) The necessar y number of target ed samples shall be taken in order to achieve the prescr ibed sam pling frequency . This 
refers to the number of animals sampled (or group of animals likely to be treated in a certain group (e.g. fish)) 
irrespective of number of tests carried our per sample .
(i) When substances from Group A and Group B are analysed in one sam ple from a sing le animal, this sample can be 
taken into account towards the minimum samp ling frequency for both groups (Group A and Group B) given that it 
can be documente d, and that the risk criteria for Group A and Group B are the same. If another sam ple of another 
matr ix is taken from the same animal for the analysis of group A and/or group B substances, the result is not take n 
into account towards the minimum sampli ng frequency . However in case substances from Group A are analysed in a EN Offi cial Jour nal of the European Union 26.9.2022 L 248/41  sample of one matr ix from a sing le animal and substances from Group B are analysed in a sample of another matr ix 
from the same animal, then both sample s can be taken into account towards the minimum sam pling frequency for 
both groups (Group A and Group B) given that it can be documented , and that the risk criteria for Group A and 
Group B have been applied.
(j) Suspect samples taken during the follow-up of a non-com pliance in accordance with Regulation (EU) 2019/2090 shall 
not be counted in order to achieve the prescr ibed sam pling frequency for the risk-based plan for EU production.
(k) For calculating the minimum sam pling frequencies, Member State s shall use the most recent production data available, 
at least from previous or at maximum from penultimate year , adjuste d, if relevant, to reflect kno wn evolutions in 
production since the data were made available.
(l) In case the sampli ng frequency calculat ed in accordance with this Annex would represent less than five samples per 
year, sampling may be carried out once per two years. In case that, within a two-y ear period, the production 
corresponding to a minimum of one sample is not reac hed, a minimum of one sample once per two years shall be 
analysed provid ed that production takes place for that species or product in the Member State.
(m) Samples taken for the purposes of other control plans relevant for analysis on phar macologically active substances and 
residues thereof (e.g. on contaminants, on pesticide residues, etc.) may also be used for controls on phar macologically 
active substances provided that the requirements concer ning the controls on phar macologically active substances are 
complied with.EN Offi cial Jour nal of the European Union L 248/42 26.9.2022  ANNEX II 
Minimum sampling frequency per Member State in the national randomised surveillance plan for 
production in the Member States (as refer red to in Article 5(c))
The minimum number of samples is as follows:
Member StateMinimum number of 
samplesMember StateMinimum number of 
samples
Belgium 195 Lithuania 50
Bulgar ia 120 Luxembourg 10
Czec hia 180 Hungar y 165
Denmark 100 Malta 10
Germany 1 425 Netherlands 300
Eston ia 25 Aust ria 150
Ireland 85 Poland 650
Greece 185 Portugal 175
Spain 805 Romania 335
France 1 150 Slovenia 35
Croatia 70 Slovakia 95
Italy 1 050 Finland 95
Cypr us 15 Sweden 175
Latvia 35 United Kingdom (Nor ther n Ireland) * 30
*In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Nor ther n Ireland from the European 
Union and the European Atomic Energy Community , and in particular Article 5(4) of the Protocol on Ireland/Nor ther n Ireland in 
conjunction with Annex 2 to that Protocol, for the purposes of this Regulation, references to Member States include the United 
Kingdom in respect of Nor ther n Ireland
Additional provisions:
(a) The samples taken under its surveillance plan shall be distr ibut ed over the different species and products according to 
the propor tion they represent under the national production and consum ption.
(b) 25 % of the sam ples, taken under this plan, shall be analysed for Group A substances.
(c) 75 % of the sam ples, taken under this plan, shall be analysed for Group B substances.EN Offi cial Jour nal of the European Union 26.9.2022 L 248/43  ANNEX III 
Minimum sampling frequency per Member State in the national risk-based control plan for third- 
countr y impor ts (as referred to in Article 6(c))
The minimum sam pling frequency can be used as a part of a monitori ng plan at border control posts in accordance with 
point 5 of Annex II to Commission Imp lementing Regulation (EU) 2019/2130 (1).
Controls carried out under the established emergency measures and the intensifi ed official controls, on the basis of 
Article 53 of Regulation (EC) No 178/2002 and of Article 65(4) of Regulation (EU) 2017/625, shall not be count ed 
towards achi eving the minimum sampli ng frequencies laid down in this Annex.
Controls of food products from certain third countr ies listed in Annex II to Commission Implementing Regulation (EU) 
2019/2129 (2), with which the Union has concluded agreements of equivalence for physical checks, shall not be count ed 
towards achi eving the minimum sampli ng frequencies laid down in this Annex.
The minimum number of samples is as follows:
Sampl ing frequency for Group A and Group B 
substances
Bovin e (includes live animals, meat, minced meat, mechanically separated 
meat, meat preparations and meat products)Minimum 7 % of the impor ted consignments
Ovine/capr ine (includes live animals, meat, minced meat, mechanically 
separated meat, meat preparations and meat products)Minimum 3 % of the impor ted consignments
Porcine (includes live animals, meat, minced meat, mechani cally separate d 
meat, meat preparations and meat products)Minimum 3 % of the impor ted consignments
Equine (includes live animals intende d for slaughter for human consump tion, 
meat, minced meat, mecha nically separate d meat, meat preparations and 
meat products)Minimum 3 % of the impor ted consignments
Poultr y*(includes live animals, poultr y meat and poultr y meat products) Minimum 7 % of the impor ted consignments
Aquacul ture (finfish, crustaceans and other aquaculture products) Minimum 7 % of the impor ted consignments
Milk (includes raw milk, dair y products, colostr um and colostr um-based 
products of all species)Minimum 7 % of the impor ted consignments
Eggs (includes eggs and egg products from all bird species) Minimum 12 % of the impor ted 
consignments
Rabbits, farmed and wild gam e**, reptiles and insects (includes live animals, 
meat and meat products of the mentioned species and products derived from 
these species)Minimum 12 % of the impor ted 
consignments for each species
Honey (includes hone y and other apiculture products) Minimum 7 % of the impor ted consignments
Casings *** Minimum 2 % of the impor ted consignments
(1)Commission Implementing Regulation (EU) 2019/2130 of 25 Novem ber 2019 establishing detailed rules on the operations to be 
carried out during and after documentar y chec ks, identity chec ks and physical chec ks on animals and goods subject to official controls 
at border control posts (OJ L 321, 12.12.2019, p. 128).
(2)Commission Implementing Regulation (EU) 2019/2129 of 25 November 2019 establishing rules for the unif orm application of 
frequency rates for identity chec ks and physical chec ks on certain consignments of animals and goods enteri ng the Union (OJ L 321, 
12.12.2019, p. 122).EN Offi cial Jour nal of the European Union L 248/44 26.9.2022  * As defin ed in point 1.3 of Annex I to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 Apr il 2004
laying down specific hygiene rules for food of animal origin (OJ L 139, 30.4.2004, p. 55).
** As defined in points 1.5 and 1.6 of Annex I to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 
29 Apr il 2004 laying down specific hygiene rules for food of animal origin (OJ L 139, 30.4.2004, p. 55).
*** As defined in Commission Delegat ed Regulation (EU) 2020/692 of 30 Januar y 2020 supplementing Regulation (EU) 2016/429 of the 
European Parliament and of the Council as regar ds rules for entr y into the Union, and the movement and handling after entr y of 
consignments of certain animals, germinal products and products of animal origin (OJ L 174, 3.6.2020, p. 379 ).
Additional provisions:
(a) For calculating the minimum sampli ng frequencies listed in this Annex, Member State s shall use the most recent data of 
the number of consignments enter ing the Union through their border control posts, at least from previous or at 
maximum from penultimate year .
(b) In case the number of consignments entering the Union is lower than the number of consignments corresponding to 
one sample , the sampli ng once per two or three years may be performe d. In case the number of consignments 
enteri ng the Union over a three-y ear period is lower than the number of consignments corresponding to one sample, 
at least one sample once per three years shall be take n.
(c) Samples taken for the purposes of other control plans relevant for analysis on phar macologically active substances and 
residues thereof (e.g. on contaminants, on pesticide residues, etc.) may also be used for controls on phar macologically 
active substances provid ed that the requirements concer ning the controls on phar macologically active substances are 
complied with.EN Offi cial Jour nal of the European Union 26.9.2022 L 248/45