EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10216/2022 ANNEX Rev. 1 
(POOL/E2/2022/10216/10216R1 -EN 
ANNEX.docx)  
[…](2022) XXX  draft  
ANNEXES 1 to 7  
 
ANNEXES  
to the  
COMMISSION DELEGATED REGULATION (EU)  
supplementing Regulation (EU) 2017/625 of the European Parliament and of the 
Council with specific requirements for the performance of official controls on the use of 
pharmacologically active substances authorised as v eterinary medicinal products or as 
feed additives and of prohibited or unauthorised pharmacologically active substances 
and residues thereof    
EN 1  EN ANNEX I  
Group  A – Prohibited or unauthorised pharmacologically active substances in food -producing 
animals   
1. Substances with hormonal and thyrostatic action and beta agonists the use of which 
is prohibited under Council Directive 96/22/EC  (1): 
(a) Stilbenes ; 
(b) Antithyroid agents ; 
(c) Steroids ; 
(d) Resorcylic acid lactones, including zeranol ; 
(e) Beta-agonists . 
2. Prohibited substances listed in Table 2 of the Annex to Regulation (EU) No 37/2010 : 
(a) Chloramphenicol ; 
(b) Nitrofurans ; 
(c) Dimetridazole, metronidazole, ronidazole and other nitro -imidazoles ;  
(d) Other substances . 
3. Pharmacologically active substances, not listed in Table 1 of the Annex to 
Regulation (EU) No 37/2010 (2) or substances not authorised for use in feed for 
food-producing animals in the U nion according to Regulation (EU) No 1831/2003  of 
the European Parliam ent and of the Council (3):  
(a) Dyes ;  
(b) Plant protection 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 husbandry of food -producing animals ; 
(c) Antimicrobial substances ; 
(d) Coccidiostats, histomonostats and other antiparasitic agents ; 
(e) Protein and peptide hormones ; 
(f) Anti-inflammatory substances, sedatives and a ny other pharmacologically 
active substance s;  
(g) Antiviral substances .  
                                                 
(1) Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of 
certain substances having a hormonal or thyrostatic action and of ß -agonists, and repealing Directives 
81/602/EEC, 88/146/EEC and 88/299/EEC (OJ L 125, 23.5.1996, p. 3).  
(2) Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically act ive 
substances and their classification regarding 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 nutrition (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 
concerning the placing of plant protection 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 
concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1 ).  
EN 2  EN Group  B – Pharmacologically active substances authorised for  use in food -producing animals  
1. Pharmacologically active substances listed 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 -inflammatory drugs (NSAIDs), corticosteroids and 
glucocorticoids ; 
(e) Other pharmacologically active  substances . 
2. Coccidiostats and histomonostats authorised according to Union legislation , for 
which maximum l evels and maximum residue limit s are set under Union legislation   
EN 3  EN ANNEX  II 
Criteria  for the selection of specific combination of substance groups and commodity 
groups for  national risk -based control plan for production in the Member States  (as 
referred to in Article 2(2) ) 
 
A. Group A substances  
1. Combinations of substance  group s and commodity groups :  
 Commodity  group  
Substance 
group  by 
reference 
to Annex I  Bovine, 
ovine 
and 
caprine  Porcine  Equine  Poultry  Aquaculture 
(finfish, 
crustaceans 
and other 
aquaculture 
products)  Raw 
bovine, 
ovine 
and 
caprine 
milk Hen 
eggs 
and 
other 
eggs Rabbits, 
farmed 
game 
and, 
reptiles 
and 
insects  Honey  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)             
EN 4  EN * As defined  in Commission Delegated Regulation (EU) 2020/692 of 30 January 2020 supplementing Regulation 
(EU) 2016/429 of the European Parliament and of the Council as regards rules for entry into the Union, and the 
movement and handling after entry of consignments o f certain animals, germinal products and products of 
animal origin (OJ L 174, 3.6.2020, p. 379). 
** Not relevant for insects  
*** Relevant only for reptiles  
**** Relevant only for finfish  
 
– The residue or substance groups shall be analysed in samples drawn from food -
producing animals including, where appropriate, their excrements, body fluids 
and unprocessed animal products, feed, water and animal by -products.  
– When there are indications or suspicions that illegal treatments may take place 
for residue or subs tance 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 States.  
2. Criteria for selecting specific substances for testing within each subs tance group : 
– frequency of the detection of non -compliance in the Member State or reported 
in the results from other Member States, or in third countries’ samples, 
especially when  reported under the Rapid Alert System for Food and Feed 
(‘RASFF ’) or the Admi nistrative Assistance and Cooperation System (‘AAC’) 
or where there is evidence that substances not authorised for use in food -
producing animals in the U nion are used in third countries ; 
– availability of suitable laboratory methods and analytical standards ; 
– pharmacologically active substances likely to be misused in order to increase 
production or increase feed conversion efficiency ; 
– prohibited or unauthorised substances for which there are indications of 
misuse ; 
– possible risk for consumers or certain popula tion groups arising from 
consumption of residues  present in food , taking into account the relevant 
information available from, inter alia , the European Medicines Agency, 
European Food Safety Authority and the Codex Alimentarius Joint Expert 
Committee on Fo od Additives or in absence of such information, other sources 
of information such as scientific publications or national risk assessment.  
3. Criteria for the selection of animals and products of animal origin:  
– indication of the use of specific pharmacologi cally active substances, including 
mutilations at the ears or the tail or the presence of injection sites ; 
– secondary sexual characteristics, behavioural changes, signs of disease or 
chronic disorders, different health status of specific animals within a gr oup; 
– sex, age and pregnancy status of the animals ; 
– veterinary history of the animal and health certificate ; 
– animals showing a good physical conformation and well -developed muscles 
with little fat.  
 
   
EN 5  EN B. Group B substances   
1. Criteria for selecting specif ic substances for testing within each substance group:  
– frequency of the detection of non -compliance in the Member State’s samples, 
in other Member States’ samples or in third countries’ samples, especially 
when reported under the RASFF or AAC.   
– availability of suitable laboratory methods and analytical standard;  
– information on the quantities of the veterinary medicinal product produced, 
imported, exported, marketed and sold for a specific food -producing animal 
species;  
– information on the veterina ry medicinal product distribution chain, the national 
register of pharmacologically active substances, authorised as veterinary 
medicinal products or feed additives, information on the most popular 
prescribing patterns;  
– the likelihood of misuse of the phar macologically active substances;  
– maximum residue limit s and maximum l evels for pharmacologically active 
substances and feed additives including restrictions (e.g. not for use in lactating 
animals);  
– formulations of veterinary medicinal products for which long withdrawal 
periods, post -animal treatment, have been established to ensure that edible 
unprocessed animal products comply with EU MRLs;  
– possible treatment of food -producing animals under Articles 113 and 114 of 
the Regulation (EU) 2019/6  of the Europe an Parliament and of the Council  (6). 
2. Criteria for the selection of substance groups and animals and products of animal 
origin:  
– information on the marketing authorisations for veterinary medicinal products 
containing pharmacologically active substances for specific animal species and 
production classes ; 
– information on the marketing authorisations for feed additives for specific 
animal species and production classes ; 
– information on the frequency of the use of substances from specific substance 
categories in specific animal species ; 
– frequency of the detection of non -complian ce for residues of 
pharmacologically active substances and feed additives per production 
category ; 
– information on the rates of antimicrobial resistance in certain animal 
production secto rs. 
                                                 
(6) Regulation  (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on 
veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43).   
EN 6  EN ANNEX III 
Criteria for sampling strategy for n ational risk -based control plan for production in the 
Member States (as referred to in Article 2(2) ) 
 
1. Sampling shall be carried out in variable intervals spread evenly over all months of 
the year or relevant production period. In this context, it shall be considered that a 
number of pharmacologically active substances are administered only in particular 
seasons.  
2. Sampling shall be performed at or close to slaughter, collection or harvest. However, 
for Group A substances sampling should also be performed at any relevant stage in 
the life cycle of the animals.  
3. All samples shall be targeted according to the criteria laid down in the national 
control plan. For Group A substances , sampling shall be targeted at detecti on of 
illegal treatment with prohibited or unauthorised substances – thus animals which are 
most likely to have been treated are preferentially selected over those animals which 
are not, and, as much of this sampling i s carried out on farm, samples of drinking 
water and feed may be appropriate in addition to inedible materials such as blood, 
urine, faeces, hair etc.   
4. For Group B substances, samples shall comprise only edible tissues/products ( the 
objective is to ver ify compliance with maximum residue limit s and maximum 
levels). Sampling shall be targeted on products from those animals , which are most 
likely to have been treated with a specific pharmacologically active substance  or 
therapeutic class of drug.  
5. Sampl es from injection sites can be appropriate to control the illegal use of 
substances. In case samples are taken from injection sites, this shall  be clearly 
mentioned when reporting analytical results from these samples.  
6. Criteria for the selection of the  animals or products to be controlled f or each food 
business operator to be controlled : 
– history of non -compliance of the farm or producer;  
– shortcomings in the application of veterinary 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 
pharmacologically active substances in the respective farm or production 
system;  
– indications of the use of pharmacologically active substances;  
– the absence or the unreliability of own -checks, the membership of quality 
assurance schemes (when ava ilable) and results of testing under such schemes;  
– evidence of insufficient supervision of the farm by veterinarians;  
– representative sampling regardless the size of the food business operator.   
EN 7  EN 7. Criteria for the selection of slaughterhouses, cutting plants, establishments for the 
milk production, establishments for the production and placing on the market of 
aquaculture products, establishments for honey and egg and egg packing centres 
from which samples should be taken:  
– the criteria listed un der points A .2 and B .1 of Annex II and point 6 of this 
Annex;  
– the respective establishments’ share of the country's total production volume ; 
– non-compliance identified in earlier controls on the use of pharmacologically 
active substances and residues thereof in animals and animal products ; 
– origins and transport routes of the slaughtered animals, milk, eggs or honey ; 
– absence of participation in quality assurance programmes (when available) ; 
– the scope and results of own -checks for residues.  
8. When takin g the samples, efforts shall be made to avoid multiple sampling (i.e. the 
taking of several different samples from a single animal/product  (unless the different 
samples are analysed for a different group of substances) , or sampling several 
animals/products  from a single producer on a given day when samples could be 
drawn from animals/products from several producers which would satisfy the 
targeting criteria ) unless the operator has been identified on the basis of the criteria 
included in point 6  or an appro priate justification has been provided in the control 
plan. The compliance with the planned frequency of checks shall be ensured .  
EN 8  EN ANNEX I V 
Criteria  for the selection of specific combination of substance groups and commodity 
groups fo r national randomised surveillance plan for production in the Member States 
(as referred to in Article 2( 3)) 
 
Group A substances  
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 substances  
Combinations of substance groups  and commodity groups :  
Substance 
group  Bovine, 
ovine 
and 
caprine  Porcine  Equine  Poultry  Aquaculture 
(finfish, 
crustaceans 
and other 
aquaculture 
products)  Raw 
bovine, 
ovine 
and 
caprine 
milk Hen 
eggs 
and 
other 
eggs Rabbits, 
farmed 
game, 
reptiles 
and 
insects  Honey  
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 listed 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 performed for as many 
pharmacologically active substances as possible, for which maximum residue limit s have 
been set in Table 1 of the Annex to Regulation (EU) No 37/2010 or for feed additives, for 
which maximum residue limit s and maximum l evels have been set pursuant to Regulation 
(EC) No 1831/2003.   
EN 9  EN ANNEX V  
Criteria for sampling strategy for  national randomised surveillance plan for production 
in the Member States  (as referred to in Article 2( 3) 
 
1. Sampling shall be random and shall be performed at or close to slaughter, collection 
or harvest and representative of th e Member States’  production/consumption pattern : 
– for Group A substances , sampling shall be performed throughout the 
production process of food -producing animals and unprocessed products of 
animal origin on live food -producing animals, their body parts, excrements and 
body fluids and in tissue, products of animal origin, animal  by-products, animal 
feed and water, whichever matrix is the most relevant.  
– for Group B substances , only fresh or frozen meat, edible offal, eggs, milk or 
honey (as close as possible to the production date), which have not undergone 
further processing or mixing , shall be sampled.  
2. In case several substance categories are to be analysed in one sample, the sample size 
shall be adjusted accordingly.   
  
EN 10  EN ANNEX VI 
Criteria  for the selection of specific combination of substance groups and  commodity  
groups for n ational risk -based control plan for third country imports (as referred 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 system for residues in imported food;  
– the outcome of Commission controls in third countries;  
– level of guarantees provided by the importer on the compliance of imported 
food of animal origin with Union legislation on pharmacologically 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 
identified in earlier Member State import controls.  
3. Relevant info rmation provided by the Commission services, where available, on :   
– the use in the third country of pharmacologically active substances that are 
prohibited or not authorised in the Union, existence of information on the 
restrictions on such use, administra tion practices for veterinary medicinal 
products (e.g. with or without the involvement of authorised animal health 
professionals);  
– the distribution of veterinary medicinal products and whether they are available 
over the counter or are subject to a veterin ary prescription;  
– whether there is an obligation to keep veterinary medicinal product treatment 
records on farms in the third country ; 
– whether and how animals are identified (and can thus be linked to treatments) .  
EN 11  EN ANNEX VII 
Criteria for sampling strategy for n ational risk -based control plan for third country 
imports (as referred to in Article 2(4) ) 
 
1. Sampling shall be targeted according to rules set out in Annex V I, supplemented by 
the relevant rules laid down in Annex I II. 
– For Grou p A substances, sampling shall be targeted at detecting the illegal 
treatment with prohibited or unauthorised substances.  
– For Group B substances, sampling shall be targeted at controlling the 
compliance with maximum residue limits or maximum levels for res idues of 
pharmacologically active substances established under Union legislation.  
2. Samples shall be taken at the point of entry into the U nion.