EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10218/2022 ANNEX CIS 
(POOL/E2/2022/10218/10218 -EN 
ANNEX CIS.docx)  
[…](2022) XXX  draft  
ANNEXES 1 to 3  
 
ANNEXES  
to the  
COMMISSION IMPLEMENTING REGULATION (EU)  
on uniform practical arrangements for the performance of official controls as regards 
the use of pharmacologically active substances authorised as veterinary medicinal 
products or as feed additives and of prohibited  or unauthorised pharmacologically 
active substances and residues thereof, on specific content of multi -annual national 
control plans and specific arrangements for their preparation    
EN 1  EN ANNEX I 
Minimum sampling frequency per Member State  in the n ational r isk-based  control plan 
for production  in the Member States ( as referred to in Article 4(c) ) 
 
The minimum number of sampl es is as follows:  
 Sampling frequency - Group A substances  
Bovine  Minimum 0.25  % of the slaughtered 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 slaughterhouse )  
Sheep and goats  Minimum 0.01  % of the slaughtered animals  per species  
Porcine  Minimum 0.02  % of the slaughtered animals  
Equine  Minimum 0.02  % of the slaughtered animals  
Poultry  For each category of poultry considered (broiler chickens, spent 
hens, turkeys and other poultry) minimum 1 sample per 400 tons 
of annual production (deadweight)  
Aquaculture ( finfish, 
crustaceans  and other 
aquaculture products ) Minimum 1 sample per 300 tonnes of annual productio n of 
aquaculture for the first 60  000 tonnes  of production and then  1 
additional sample for each additional 2 000 tonnes  
Bovine, ovine and 
caprine milk  Minimum 1 sample per 30  000  tonnes of annual productio n of 
milk per spec ies 
Hen eggs and other 
eggs Minimum 1 sample per 2  000 tonnes of annual productio n of eggs  
per species  
Rabbits, farmed game, 
reptiles and insects  Minimum 1 sample per 1 00 tonnes  of annual production (dead 
weight) of r abbits, farmed game or reptiles for the first 3  000 
tonnes of production and 1 sample for each additional 1  000 
tonnes  
Minimum 1 sample per 25 tonnes annual production of  insects  
Honey  Minimum 1 sample per 50 tonnes of annual production  for  the 
first 5 000 tonnes of production and then 1 a dditional sample for 
each additional 500 tonnes  
Casings* Minimum 1 sample per 300 tonnes of annual production  
* As defined in Commission Delegated Regulation (EU) 2020/692 of 30 January 2020 supplementing Regulation 
(EU) 2016/429 of the European Parliame nt and of the Council as regards rules for entry into the Union, and the 
movement and handling after entry of consignments of certain animals, germinal products and products of 
animal origin (OJ L 174, 3.6.2020, p. 379).  
  
EN 2  EN  
 Sampling frequency - Group B  substances  
Bovine  Minimum 0.10  % of the slaughtered animals  
Sheep and goats  Minimum 0.02  % of the slaughtered animals  per species  
Porcine  Minimum 0.02  % of the slaughtered animals  
Equine  Minimum 0.02  % of the slaughtered animals  
Poultry  For each ca tegory of poultry considered (broiler chickens, spent 
hens, turkeys and other poultry) minimum 1 sample per 500 
tonnes of annual production (deadweight)  
Aquaculture (finfish, 
crustaceans and other 
aquaculture products)  Minimum 1 sample per 300 tonnes of annual production of 
aquaculture for the first 60  000 tonnes  of production and then 1 
additional sample for each additional 2 000 tonnes   
Bovine, ovine and 
caprine milk  Minimum 1 sample per 30  000 tonnes of annual production of 
milk per species  
Hen e ggs and other 
eggs Minimum 1 sample per 2  000 tonnes of annual production of 
eggs per species  
Rabbits, farmed game, 
reptiles and insects  Minimum 1  sample per 50  tonnes  of annual production (dead 
weight) of r abbits, farmed game or reptiles for the first 3 000 
tonnes of production and 1 sample for each additional 500 tonnes  
Minimum 1 sample per 25 tonnes annual production of  insects  
Honey  Minimum 1 sample per 50 tonnes of annual production  for  the 
first 5 000 tonnes of production and then 1 additional sa mple for 
each additional 500 tonnes  
 
Additional provisions  
(a) If relevant to verify compliance with Union legislation on the use of prohibited or 
unauthorised pharmacologically active substances, Member States may take samples 
from feed, water or another rel evant matrix or environment and counted towards 
achieving the minimum sampling frequencies provided for in this Annex.  
(b) Controls on each combination of sub-group s of Group A substances and commodity 
groups as listed in Annex I I to Delegated Regulation (EU) C(2022) 4400  shall be 
annually performed 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 commodi ty 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 
Delegated Regulation (EU) C(2022) 4400 .  
EN 3  EN (d) Within bovine, ovine and caprine group , the samples  shall be taken from all species , 
taking into account their relative production volume. Sampling shall cover both 
animals for dairy production and for meat production.  
(e) Within the poultry group, samples  shall be taken from broiler chickens, spe nt hens, 
turkey and other poultry, 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 pharmacologically active substances are being 
applied to the other aquaculture products, then these species must be included in the 
sampling plan in proportion to their production as additional samples to those taken 
for finfish fa rming products.  
(h) The necessary number of targeted samples shall be taken in order to achieve the 
prescribed sampling frequency. This refers to the number of animals sampled (or 
group of animals likely to be treated in a certain group (e.g. fish)) irrespecti ve of 
number of tests carried our per sample.  
(i) When substances from Group A and Group B are analysed in one sample from a 
single animal, this sample can be taken into account towards  the minimum sampling 
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 are the same. If another sample  of 
another matrix  is taken from the same animal  for the analysis of group A and/or group 
B substances, the result is not taken into account towards  the minimum sampling 
frequency.  However in case substance s from Group A are analysed in a sample of one 
matrix  from a single animal and substance s from Group B are analysed in a sample of 
another matrix from the same animal, then both samples can b e taken into account 
towards the minimum sampling 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 -compliance in accordance with 
Regulation (EU) 2019/2090 shall not be counted in order to achieve the prescribed 
sampling frequency for the risk -based plan for EU -production.  
(k) For calculating the minimum sampling frequencies, Member States shall use  the most 
recent  production data available , at least from previous or at maximum from 
penultimate year , adjusted, if relevant, to reflect known evolutions  in production since 
the data were made available .  
(l) In case the sampling frequency calculated 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 years period , the production corresponding to a 
minimum of one sample is not reached, a minimum of one sample once per  two years  
shall be analysed provided 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 
pharmacologically active substances and residues thereof (e.g.  on contaminants, on 
pesticide residues, etc.) may also be used for controls on pharmacologic ally active 
substances provided that the requirements concerning the controls on 
pharmacologically active substances are complied  with.  
EN 4  EN ANNEX  II 
Minimum sampling frequenc y per Member State in the n ational randomised 
surveillance plan for production in the Member States ( as referred to in Article 5(c)) 
 
 The minimum number of samples  is as follows:  
Member State  Minimum number 
of samples  Member State  Minimum number 
of samples  
Belgium  195 Lithuania  50 
Bulgaria  120 Luxembourg  10 
Czechia  180 Hungary  165 
Denmark  100 Malta  10 
Germany  1 425 Netherlands  300 
Estonia  25 Austria  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 
Cyprus  15 Sweden  175 
Latvia  35 United Kingdom (Northern 
Ireland )* 30 
* In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern 
Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of 
the Protocol on Ireland / Northern Ireland in conjunction with Annex 2 to that Protocol, for the purpos es of this 
Regulation, references to Member States include the United Kingdom in respect of Northern Ireland  
 
Additional provisions:  
(a) The samples taken under its surveillance plan shall be distributed over the different 
species and products according to the  proportion they represent under the national 
production and consumption.  
(b) 25 % of the samples, taken under this plan, shall be analysed for Group A substances.  
(c) 75 % of the samples, taken under this plan, shall be analysed for Group B substances. 
EN 5  EN ANNEX  III 
Minimum sampling frequency per Member State in the n ational risk -based control plan 
for third country imports ( as referred to in Article 6(c))  
 
The minimum sampling frequency can be used as a part of a monitoring plan at border contr ol 
posts in accordance with point 5 of Annex II to Regulation (EU) 2019/2130 (1). 
Controls carried out under the established emergency measures and the intensified official 
controls, on the basis of Article 53 of Regulation (EC) 178/2002 and of Article 65( 4) of 
Regulation (EU) 2017/625, shall not be counted towards achieving the minimum sampling  
frequencies laid down in  this Annex.  
Controls of food products from certain third countries listed in Annex II to Regulation (EU) 
2019/2129 (2), with which the Union has concluded agreements of equivalence for physical 
checks, shall not be counted towards achieving the minimum sampling frequencies laid down 
in this Annex.  
The minimum number of samples is as follows:  
 Sampling frequency for Group  A 
and Group B substances  
Bovine  (includes live animals, meat, minced meat, 
mechanically separated meat, meat preparations and 
meat products)  Minimum 7  % of the imported 
consignments  
Ovine/caprine (includes live animals, meat, minced 
meat, mechanically separated meat, meat 
preparations and meat products)  Minimum 3 % of the imported 
consignments  
Porcine (includes live animals, meat, minced meat, 
mechanically separated meat, meat preparations and 
meat products)  Minimum 3 % of the imported 
consignments  
Equine (includes live animals  intended for slaughter 
for human consumption , meat, minced meat, 
mechanically separated meat, meat preparations and 
meat products)  Minimum 3 % of the imported 
consignments  
Poultry* (includes live animals, poultry meat and 
poult ry meat products)   Minimum 7 % of the imported 
consignments  
Aquaculture (finfish, crustaceans and other 
aquaculture products)  Minimum 7 % of the imported 
consignments  
Milk (includes raw milk, dairy products, colostrum Minimum 7 % of the imported 
                                                 
(1) Commission Implementing Regulation (EU) 2019/2130 establishing detailed rules on the operations to 
be carried out during and after documentary checks, i dentity checks and physical checks on animals and 
goods subject to official controls at border control posts (OJ L 321, 12.12.2019, p. 122).  
(2) Commission Implementing Regulation (EU) 2019/2129 of 25 November 2019 establishing rules for the 
uniform applic ation of frequency rates for identity checks and physical checks on certain consignments 
of animals and goods entering the Union  (OJ L 321, 12.12.2019, p. 122).   
EN 6  EN and colostrum -based products of all species)  consignments  
Eggs (includes eggs and egg products from all bird 
species)  Minimum 12 % of the imported 
consignments  
Rabbits, farmed and wild game**, reptiles and insects  
(includes live animals, meat and meat products of the 
mentioned species and products derived from these 
species)  Minimum 12 % of the imported 
consignments for each species  
Honey (includes honey and other apiculture 
products)  Minimum 7 % of the imported 
consignments  
Casings*** Minimum 2 % of  the imported 
consignments  
* As defined in point 1.3 of Annex I to Regulation (EC) No 853/2004 of the European Parliament and of the 
Council of 29 April 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 April 2004 laying down specific hygiene rules for food of animal origin (OJ L 139 
30.4.2004, p. 55).  
*** As defined in Commission De legated 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 of certain animals , germinal products and 
products of animal origin (OJ L 174, 3.6.2020, p. 379).  
 
Additional provisions:  
(a) For calculatin g the minimum sampling frequencies listed in this Annex, the most 
recent data of the number of consignments entering the Union through the ir border 
control posts , at least from previous or at maximum from penultimate year , shall be 
used.  
(b) In case the number of consignments entering the Union is lower than the number of 
consignments corresponding to one sample, the sampling once per two or three years  
may be performed . In case the number of consignments entering the Union over a 
three years period is lower than the number of consignments  corresponding to one 
sample, at least one sample once per  three years  shall be taken . 
(c) Samples taken for the purposes of other control plans relevant for analysis on 
pharmacologically active substances and residues thereof (e.g. on contaminants, on 
pesticide residues, etc.) may also be used for controls on pharmacologically active 
substances provided that the  requirements concerning the controls on 
pharmacologically active substances are complied with.