REGUL ATIONS
COMMISSION DELEGA TED REGUL ATION (EU) 2022/1644 
of 7 July 2022
supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with 
specif ic requirements for the perfor mance of official controls on the use of phar macologically activ e 
subst ances 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 
(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(2), point (a), 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 specif ic requirements for the performa nce of those offici al controls, 
including, where appropr iate, the rang e of samples and the stage of production, processing and distr ibution where 
the sam ples have to be take n, having regar d to the hazards and risks related to the 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 perf orm the offici al controls necessar y in accordance with Directive 
96/23/EC to detect the presence of certain substances and groups of residues. Specifically , the transito ry measures 
set requirements for Member States’ monitori ng plans for the detection of residues or substances within its scope.
(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 26.9.2022 L 248/3  (3) This Regulation ensures the continuity of the rules laid down in Directive 96/23/EC concer ning 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.
(4) This Regulation sets rules for the range of sam ples and the stage of production, processing and distr ibution at whic h 
the sam ples are to be taken 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.
(5) In order to ensure that controls are effectively targe ted in all Member State s, it is appropr iate to set out rules on the 
combinations of substance groups and commodity groups to be sam pled by Member States and the sam pling 
strateg y, including criteria to define the conte nt of national risk-based plans and randomised surveillance plans and 
the performa nce of the related official controls.
(6) Commission Imp lementing Regulation (EU) 2022/1646 (3)lays down the unif orm practical arrange ments for the 
performa nce of official controls as regar ds the use of phar macologically active substances author ised as veter inar y 
medicinal products or as feed additives and of prohibit ed or unauthor ised phar macologically active substances and 
residues thereof and also specifi es the conte nt and arrange ments of the MANCP as regards these substances and 
residues
(7) Articles 4, 5 and 6 of Imple menting Regulation (EU) 2022/1646 specify the content of national risk-based plans and 
randomised surveillance plan focused on official controls on the use of phar macologically active substances 
author ised as veterinar y medicinal products or as feed additives and of prohibit ed or unauthor ised 
phar macologically active substances and residues thereof. These plans should contain, inter alia, the list of 
combinations of substances and species, products and matr ices which are included in the control plans for which 
the rules for that selection are defined in this Delegat ed Regulation. Member States should include in their national 
plans also sampli ng strategy for whic h criteria mentioned in this Deleg ated Regulation should be taken into account.
(8) 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 ,
HAS ADOPTED THIS REGUL ATION:
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 (4), Commission Deleg ated Regulation (EU) 2019/2090 (5)and Commission Implementing Regulation 
(EU) 2021/808 (6)apply .
(3)Commission Implementing Regulation (EU) 2022/1646 of 7 July 2022 on unif orm practical arrangements for the perfor mance of 
official controls as regar ds 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, on specific content of multi- 
annual national control plans and specific arrangem ents for their preparation (See page 32 of this Offi cial Jour nal).
(4)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).
(5)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).
(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 248/4 26.9.2022  In addition, the followi ng definitions apply:
(1) ‘official sam ple’ means a sample taken by the compet ent author ity, 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 concer ned, the method of 
collection and particulars identifying the sex of the animal and the origin of the animal or of the product of animal 
origin, as applicable.
(2) ‘targ eted sampli ng’ means taking official sam ple or sample s with the aim of maximising the possibility of detec ting 
non-com pliance with maximum residue limits or maximum levels, established under Union legislation for 
phar macologically active substances.
(3) ‘random sampling’ means the taking of an official sample or samples under statistical consideration to provid e 
representative data
(4) ‘suspect sampli ng’ means taking official samp les as a follow-up to non-com pliant control results or as the follow-up to 
any suspected or established non-complian ce with Union rules on phar macologically active substances, as laid down in 
Regulation (EU) 2019/2090.
(5) ‘matr ix’ means the mater ial from which a sample is take n, including animal body parts, fluids, excrements, tissues, 
products of animal origin, animal by-products, animal feed and wate r.
(6) ‘food-producing animals’ means animals bred, raised, kept, slaughtere d or harvested for the purposes of producing 
food.
(7) ‘residue’ means a residue of substances having a phar macological action, of metabolites of such substances, degradation 
products of such substances and of other related substances present in animals or products of animal origin.
Article 2
1. Member States shall control the use of phar macologically active substances author ised as veteri nary medicinal 
products or as feed additives and the presence of prohibit ed or unauthor ised phar macologically active substances and 
residues thereof listed in Annex I.
2. For national risk-based control plans for production in the Member States, as specif ied in Article 4 of Implementing 
Regulation (EU) 2022/1646, Member States shall control combinations of substance groups and commodity groups in 
accordance with Annex II to this Regulation and they shall adop t a sampli ng strateg y in accordance with the criteria set 
out in Annex III to this Regulation.
3. For national randomised surveillance plans for production in the Member States, as specifi ed in Article 5 of 
Implementing Regulation (EU) 2022/1646, Member States shall control combinations of substance groups and 
commodity groups in accordance with Annex IV to this Regulation and they shall adop t a sampli ng strateg y in accordance 
with the criteria set out in Annex V to this Regulation.
4. For national risk-based control plans for third countr y imports, as specifi ed in Article 6 of Implementing Regulation 
(EU) 2022/1646, 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 Regulation.EN Offi cial Jour nal of the European Union 26.9.2022 L 248/5  Article 3
References to Annex es II and III to Directive 96/23/EC shall be constr ued as references to this Regulation.
Article 4
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union.
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, 7 July 2022 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 248/6 26.9.2022  ANNEX I 
Group A – Prohibit ed or unauthor ised phar macologically active substances in food-producing animals
1.Substances with hormonal and thyrostatic action and beta agonists the use of whic h is prohibit ed under Council 
Directive 96/22/EC (1):
(a) Stilbenes;
(b) Antithyroid agents;
(c) Steroids;
(d) Resorcylic acid lacto nes, including zeranol;
(e) Beta-agonists.
2.Prohibit ed substances listed in Table 2 of the Annex to Regulation (EU) No 37/2010:
(a) Chloramphenicol;
(b) Nitrofurans;
(c) Dimetr idazole, metronidazole, ronidazole and other nitro-imidazoles;
(d) Other substances.
3.Phar macologically active substances, not listed in Table 1 of the Annex to Regulation (EU) No 37/2010 (2)or substances 
not author ised for use in feed for food-producing animals in the Union according to Regulation (EU) No 1831/2003 of 
the European Parliament and of the Council (3):
(a) Dyes;
(b) Plant prote ction products as defined in Regulation (EU) No 1107/2009 of the European Parliament and of the 
Council (4)and biocides as defined in Regulation (EU) No 528/2012 of the European Parliament and of the 
Council (5)which may be used in animal husbandr y of food-producing animals;
(c) Antimicrobial substances;
(d) Coccidiostats, histo monostats and other antiparasitic agents;
(e) Protein and peptide hormones;
(f) Anti-inf lammatory substances, sedatives and any other phar macologically active substances;
(g) Antiviral substances.
(1)Council Directive 96/22/EC of 29 Apr il 1996 concer ning the prohibition on the use in stoc kfar ming of certain substances havin g 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).
(2)Commission Regulation (EU) No 37/2010 of 22 December 2009 on phar macologically active substances and their classif ication 
regar ding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1).
(3)Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal 
nutr ition (OJ L 268, 18.10.2003, p. 29).
(4)Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concer ning the placing of plant 
prot ection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).
(5)Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concer ning the making available on the 
market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).EN Offi cial Jour nal of the European Union 26.9.2022 L 248/7  Group B – Phar macologically active substances author ised for use in food-producing animals
1.Phar macologically active substances liste d in Table 1 of the Annex to Regulation (EU) No 37/2010:
(a) Antimicrobial substances;
(b) Insecticides, fungicides, anthelmintics and other antiparasitic agents;
(c) Sedatives;
(d) Non-steroidal anti-inf lammat ory drugs (NSAIDs), corticosteroids and glucocor ticoids;
(e) Other phar macologically active substances.
2.Coccidiostats and histomonostats author ised according to Union legislation, for which maximum levels and maximum 
residue limits are set under Union legislationEN Offi cial Jour nal of the European Union L 248/8 26.9.2022  ANNEX II 
Criter ia for the selection of specif ic combination of subst ance groups and commodity groups for 
national risk-based control plan for production in the Member States (as refer red to in Article 2(2)) 
A.Group A subst ances
1.Combinations of substance groups and commodity groups:
Commodity group
Substance 
group by 
reference to 
Annex IBovine, 
ovine 
and 
capr inePorcine Equine Poultr yAquaculture 
(finfish, 
crustaceans 
and other 
aquaculture 
products)Raw 
bovine, 
ovine 
and 
capr ine 
milkHen 
eggs 
and 
other 
eggsRabbits, 
farmed 
gam e 
and, 
reptil es 
and 
insectsHoney Casings (*)
A(1), point (a) X X X(**)
A(1),  
point (b)X X X X(***)
A(1), point (c) X X X X(****) X(***)
A(1),  
point (d)X X X(***)
A(1), point (e) X X X X X(***)
A(2) X X X X X X X X X X
A(3), point (a) X
A(3),  
point (b)X X X X X X X X X
A(3), point (c) X X X X X X X X(**) X
A(3),  
point (d)X X X X X(**)
A(3), point (e)
A(3), point (f) X X X X X X X X X
A(3), point (g)
(*) As defin ed 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 ).
(**) Not relevant for insects
(***) Relevant only for reptil es
(****) Relevant only for finfishEN Offi cial Jour nal of the European Union 26.9.2022 L 248/9  — The residue or substance groups shall be analysed in sam ples drawn from food-producing animals including, where 
appropr iate, their excre ments, body fluids and unprocessed animal products, feed, wate r and animal by-products.
— When there are indications or suspicions that illegal treatments may take place for residue or substance groups in 
species or products not covered by the table of this Annex, these controls shall be also included in the risk-based 
control plan for production in the Member State s.
2.Criteria for selecting specifi c substances for testing within each substance group:
— frequency of the detection of non-com pliance in the Member State or repor ted in the results from other Member 
States, or in third countr ies’ sam ples, especially when repor ted under the Rapid Aler t System for Food and Feed 
(‘RASFF’) or the Administrative Assistance and Cooperation System (‘AAC’) or where there is evidence that 
substances not author ised for use in food-producing animals in the Union are used in third countr ies;
— availability of suitable laborat ory methods and analytical standards;
— phar macologically active substances likely to be misused in order to increase production or increase feed 
conver sion efficiency ;
— prohibit ed or unauthor ised substances for which there are indications of misuse;
— possible risk for consumers or certain population groups arising from consump tion of residues present in food, 
taking into account the relevant information available from, inter alia, the European Medicines Agen cy, European 
Food Safe ty Author ity and the Codex Alimentar ius Joint Exper t Committ ee on Food Additives or in absence of 
such information, other sources of information such as scientifi c publications or national risk assessment.
3.Criteria for the selection of animals and products of animal origin:
— indication of the use of specifi c phar macologically active substances, including mutilations at the ears or the tail or 
the presence of injection sites;
— secondar y sexual charact eristics, behavioural chang es, signs of disease or chronic disorders, differ ent health status of 
specific animals within a group;
— sex, age and pregnancy status of the animals;
— veterinar y histo ry of the animal and health certificate;
— animals showi ng a good physical conf ormation and well-developed muscles with little fat.
B.Group B subst ances
1.Criteria for selecting specifi c substances for testing within each substance group:
— frequency of the detec tion of non-com pliance in the Member State’s sam ples, in other Member States’ samples or in 
third countr ies’ samples, especially when repor ted under the RASFF or AAC;
— availability of suitable laborat ory methods and analytical standard;
— information on the quantities of veteri nary medicinal products produced, imported, expor ted, mark eted and sold 
for a specif ic food-producing animal species;
— information on the veteri nary medicinal product distr ibution chain, the national registe r of phar macologically 
active substances author ised as veteri nary medicinal products or feed additives, information on the most popular 
prescr ibing patt erns;
— the likelihood of misuse of the phar macologically active substances;
— maximum residue limits and maximum levels for phar macologically active substances and feed additives including 
restr ictions (e.g. not for use in lactating animals);EN Offi cial Jour nal of the European Union L 248/10 26.9.2022  — formulations of veterinar y medicinal products for which long withdra wal periods, post-animal treatment, have 
been established to ensure that edible unpro cessed animal products compl y with EU MRLs;
— possible treatment of food-producing animals under Articles 113 and 114 of Regulation (EU) 2019/6 of the 
European Parliament and of the Council (1).
2.Criteria for the selection of substance groups and animals and products of animal origin:
— information on the mark eting author isations for veterinar y medicinal products containing phar macologically active 
substances for specifi c animal species and production classes;
— information on the mark eting author isations for feed additives for specifi c animal species and production classes;
— information on the frequency of the use of substances from specifi c substance categor ies in specifi c animal species;
— frequency of the detection of non-com pliance for residues of phar macologically active substances and feed additives 
per production catego ry;
— information on the rates of antimicrobial resistance in certain animal production sectors.
(1)Regulation (EU) 2019/6 of the European Parliament and of 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).EN Offi cial Jour nal of the European Union 26.9.2022 L 248/11  ANNEX III 
Criter ia for sampling strategy for national risk-based control plan for production in the Member 
States (as refe rred to in Article 2(2)) 
1. Sampli ng shall be carried out in variable inter vals spread evenly over all months of the year or relevant production 
period. In this cont ext, it shall be considered that a number of phar macologically active substances are administ ered 
only in particular seasons.
2. Sampli ng shall be performe d at or close to slaughter , collection or harvest. However , for Group A substances sampli ng 
should also be performe d at any relevant stage in the life cycle of the animals.
3. All samples shall be target ed according to the criteria laid down in the national control plan. For Group A substances, 
sampli ng shall be target ed at detection of illegal treatment with prohibit ed or unauthor ised substances – thus animals 
which are most likely to have been treated are prefe rentially selected over those animals which are not, and, as much of 
this sampli ng is carried out on farm, sam ples of drinking water and feed may be appropr iate in addition to inedible 
mate rials such as blood, urine, faeces, hair etc.
4. For Group B substances, sam ples shall compr ise only edible tissues/products (the objective is to verify compl iance with 
maximum residue limits and maximum levels). Sampli ng shall be targe ted on products from those animals, whic h are 
most likely to have been treated with a specific phar macologically active substance or substance within therapeutic 
class of veteri nary medicinal products.
5. Sample s from injection sites can be appropr iate to control the illegal use of substances. In case samples are taken from 
injection sites, this shall be clearly mentioned when repor ting analytical results from these sam ples.
6. Criteria for the selection of the animals or products to be controlled for each food business operator to be controlled:
— histo ry of non-com pliance of the farm or producer;
— shor tcomings in the application of veterinar y medicinal products, deficiencies identified in previous controls, 
repor ted increase of losses of animals on the farm, animal health status of the farm, epidemiological status of the 
region;
— information on the farming system, fattening system , breed and sex of the animals;
— common practices with regard to the administration of particular phar macologically active substances in the 
respective farm or production syste m;
— indications of the use of phar macologically active substances;
— the absence or the unreliability of own-c hecks, the membership of quality assurance schemes (when available) and 
results of testing under such schemes;
— evidence of insufficient super vision of the farm by veterinar ians;
— representative sampling regardless the size of the food business operator .
7. Criteria for the selection of slaughte rhouses, cutting plants, establishments for the milk production, establishments for 
the production and placing on the mark et of aquaculture products, establishments for hone y and egg and egg packi ng 
centres from which samples should be take n:
— the criteria listed under points A.2 and B.1 of Annex II and point 6 of this Annex;
— the respective establishments’ share of the countr y’s total production volume;
— non-com pliance identif ied in earlier controls on the use of phar macologically active substances and residues 
thereof in animals and animal products;EN Offi cial Jour nal of the European Union L 248/12 26.9.2022  — origins and transpor t routes of the slaughter ed animals, milk, eggs or hone y;
— absence of participation in quality assurance programmes (when available);
— the scope and results of own-chec ks for residues.
8. When taking the samples, efforts shall be made to avoid multiple sam pling (i.e. the taking of several diffe rent sam ples 
from a sing le animal/product (unless the different samples are analysed for a diffe rent group of substances), or 
sampli ng several animals/products from a sing le producer on a given day when samples could be drawn from 
animals/products from several producers which would satisfy the targe ting criteria) unless the operator has been 
identif ied on the basis of the criteria included in point 6 or an appropr iate justif ication has been provid ed in the 
control plan. The compl iance with the planned frequency of checks shall be ensured.EN Offi cial Jour nal of the European Union 26.9.2022 L 248/13  ANNEX IV 
Criter ia for the selection of specif ic combination of subst ance groups and commodity groups for 
national randomised surveillance plan for production in the Member States (as refer red to in  
Article 2(3)) 
Group A subs tances
Samples taken are of combination of substance groups and commodity groups in addition to what is not provided for in 
the Member States’ risk-based national plan for production in the Member States.
Group B subst ances
Combinations of substance groups and commodity groups:
Substance 
groupBovine, 
ovine and 
capr inePorcine Equine Poultr yAquaculture 
(finf ish, 
crustaceans 
and other 
aquaculture 
products)Raw 
bovine, 
ovine and 
capr ine 
milkHen eggs 
and other 
eggsRabbits, 
farm ed 
game, 
reptiles 
and 
insectsHoney
B1a X X X X X X X X X
B1b X X X X X X X X X
B1c X X X X
B1d X X X X X X
B1e X X X X X X X X X
B2 X X X X X X X
Each sample for a specific type of animal or product shall be analysed for as wide range of the substance groups liste d in the 
table included in this Annex as practically feasible.
It shall be ensured that for a specific type of animal or product all substance groups listed in the table are covered by the 
surveillance plan. The controls shall be performe d for as many phar macologically active substances as possible, for which 
maximum residue limits have been set in Table 1 of the Annex to Regulation (EU) No 37/2010 or for feed additives, for 
which maximum residue limits and maximum levels have been set pursuant to Regulation (EC) No 1831/2003.EN Offi cial Jour nal of the European Union L 248/14 26.9.2022  ANNEX V 
Criter ia for sampling strategy for national randomised surveillance plan for production in the 
Member States (as refer red to in Article 2(3) 
1. Sampli ng shall be random and shall be performe d at or close to slaughter , collection or harvest and representative of 
the Member States’ production/consump tion patt ern:
— for Group A substances, sampling shall be performe d throughout the production process of food-producing 
animals and unprocessed products of animal origin on live food-producing animals, their body parts, excre ments 
and body fluids and in tissue, products of animal origin, animal by-products, animal feed and wate r, whic hever 
matr ix is the most relevant,
— for Group B substances, only fresh or frozen meat, edible offal, eggs, milk or hone y (as close as possible to the 
production date), whic h have not undergone further processing or mixing, shall be sampled.
2. In case several substance catego ries are to be analysed in one samp le, the sam ple size shall be adjusted according ly.EN Offi cial Jour nal of the European Union 26.9.2022 L 248/15  ANNEX VI 
Criter ia for the selection of specif ic combination of subst ance groups and commodity groups for 
national risk-based control plan for third countr y impor ts (as refer red to in Article 2(4)) 
1. The relevant criteria listed in Annex II
2. Information where available and relevant, on:
— the RASFF notifications and AAC syste m for residues in impor ted food;
— the outcome of Commission controls in third countr ies;
— level of guarant ees provided by the impor ter on the compliance of impor ted food of animal origin with Union 
legislation on phar macologically active substances including compl iance with Union maximum residue limits and 
maximum levels or attestations on non-use of certain substances;
— records of non-compliances for individual food business operators or importers identif ied in earlier Member State 
imp ort controls.
3. Relevant information provid ed by the Commission services, where available, on:
— the use in the third countr y of phar macologically active substances that are prohibit ed or not author ised in the 
Union, existence of information on the restr ictions on such use, administration practices for veteri nary medicinal 
products (e.g. with or without the involvement of author ised animal health professionals);
— the distr ibution of veterinar y medicinal products and whether they are available over the counter or are subject to 
a veterinar y prescr iption;
— whether there is an oblig ation to keep veter inar y medicinal product treatment records on farms in the third 
countr y;
— whether and how animals are identif ied (and can thus be linked to treatments).EN Offi cial Jour nal of the European Union L 248/16 26.9.2022  ANNEX VII 
Criter ia for sampling strategy for national risk-based control plan for third countr y impor ts (as 
refer red to in Article 2(4)) 
1. Sampli ng shall be target ed according to rules set out in Annex VI, supplemented by the relevant rules laid down in 
Annex III.
— For Group A substances, sam pling shall be target ed at detecting the illegal treatment with prohibit ed or 
unauthor ised substances.
— For Group B substances, sam pling shall be targe ted at controlling the compliance with maximum residue limits or 
maximum levels for residues of phar macologically active substances established under Union legislation.
2. Sample s shall be taken at the point of entr y into the Union.EN Offi cial Jour nal of the European Union 26.9.2022 L 248/17