II
(Non-legislative acts)
REGUL ATIONS
COMMISSION DELEGA TED REGUL ATION (EU) 2022/2292 
of 6 September 2022
supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with regard 
to requirements for the entr y into the Union of consignments of food-producing animals and certain 
goods intended for human consumption 
(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 126(1) 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, in particular to ensure compl iance, by consignments of animals and 
goods from third countr ies or regions thereof intended for human consump tion, upon entr y into the Union, with 
Union legislation on food and feed safety .
(2) Regulation (EU) 2017/625 empo wers the Commission to adopt delega ted acts to supplement the conditions laid 
down in that Regulation for the entr y into Union of food-producing animals and certain goods. Those conditions 
may include additional requirements, namely the possibility of allowing the entr y of animals and goods only from 
third countr ies that appear on lists drawn up by the Commission for that purpose. These additional requirements 
include guarantees of compliance with:
— measures to monitor substances and groups of residues in animals and goods intended for human consum ption, 
in accordance with Council Directives 96/23/EC (2)and 96/22/EC (3),
(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).
(3)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 beta-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC (OJ L 125, 
23.5.1996, p. 3).EN Offi cial Jour nal of the European Union 24.11.2022 L 304/1  — the rules for the prevention, control and eradication of transmissible spongif orm encephalopathies in live 
animals and products of animal origin, in accordance with Regulation (EC) No 999/2001 of the European 
Parliament and of the Council (4),
— the general principles and requirements govern ing food in general and food safety in particular at Union and 
national level, in accordance with Regulation (EC) No 178/2002 of the European Parliament and of the 
Council (5),
— the general rules for food business operat ors on the hygiene of foodstuffs, in accordance with Regulation (EC) 
No 852/2004 of the European Parliament and of the Council (6),
— the specifi c rules on the hygiene of food of animal origin for food business operat ors, in accordance with 
Regulation (EC) No 853/2004 of the European Parliament and of the Council (7),
— the specific rules on official controls performe d, and for actions taken, by the compet ent author ities on the 
production of certain animals and products of animal origin intended for human consump tion, in accordance 
with Commission Delegat ed Regulation (EU) 2019/624 (8)and Commission Implementing Regulation (EU) 
2019/627 (9).
(3) Commission Delegat ed Regulation (EU) 2019/625 (10)lays down such additional requirements and applies since 
14 December 2019 . It does not cover the requirements already laid down in Directive 96/23/EC.
(4) At present, third countr ies from whic h animals and products of animal origin are author ised for the entr y into the 
Union as regards the Union rules on public health are included and kept on lists drawn on the basis of various 
requirements, including the existen ce of a control plan for phar macologically active substances, pesticides and 
contaminants setting out guarantees on the monitoring of certain groups of substances and their residues and 
contaminants, in accordance with the requirements of Directive 96/23/EC.
(5) Regulation (EU) 2017/625 repealed Directive 96/23/EC with effect from 14 December 2019 and provid ed for the 
transitional application, until 14 December 2022 , of certain provisions of that Directive.
(6) The introduction of additional requirements to ensure compl iance with the measures for monitori ng substances and 
groups of residues in animals and goods intended for human consum ption laid down in Directive 96/23/EC should 
be combined with the additional requirements already laid down in Delegat ed Regulation (EU) 2019/625.
(7) It is thus appropr iate to lay down all these additional requirements in one sing le Delegat ed Regulation, thereby 
simplifying their interpretat ion and application and enhancing transparency for third countr ies.
(4)Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, 
control and eradication of certain transmissible spongif orm encephalopathies (OJ L 147, 31.5.2001, p. 1).
(5)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).
(6)Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 Apr il 2004 on the hygiene of foodstuffs (OJ L 139, 
30.4.2004, p. 1).
(7)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).
(8)Commission Delegat ed Regulation (EU) 2019/624 of 8 Febr uary 2019 concer ning specific rules for the perf ormance of official 
controls on the production of meat and for production and relaying areas of live bivalve molluscs in accordance with Regulation (EU) 
2017/625 of the European Parliament and of the Council (OJ L 131, 17.5.2019, p. 1).
(9)Commission Implementing Regulation (EU) 2019/627 of 15 March 2019 laying down unif orm practical arrangements for the 
perf ormance 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).
(10)Commission Delegat ed Regulation (EU) 2019/625 of 4 March 2019 supplementing Regulation (EU) 2017/625 of the European 
Parliament and of the Council with regar d to requirements for the entr y into the Union of consignments of certain animals and goods 
intended for human consump tion (OJ L 131, 17.5.2019, p. 18).EN Offi cial Jour nal of the European Union L 304/2 24.11.2022  (8) Regulation (EC) No 853/2004 lays down requirements for food business operat ors enter ing products of animal 
origin into the Union. According ly, the additional requirements laid down in this Regulation for official controls 
should be consistent with those already laid down in Regulation (EC) No 853/2004.
(9) When laying down requirements for the entr y into the Union of consignments of certain animals and good intende d 
for human consum ption, reference should be made to the Combined Nomenclature codes set out in Council 
Regulation (EEC) No 2658/87 (11), to identify these goods and animals clearly .
(10) Consignments of certain animals and goods intended for human consum ption should only be allowe d to enter the 
Union, based on a risk analysis, where the third countr ies or regions thereof from whic h these animals and goods 
originate can ensure compliance with the requirements on the safety of those animals and goods and those third 
countr ies or regions thereof are included, in accordance with Article 127(2) of Regulation (EU) 2017/625, in the 
lists laid down in Commission Implementing Regulation (EU) 2021/405 (12).
(11) In addition to the requirements laid down in Article 127(3) of Regulation (EU) 2017/625, specifi c requirements 
should be laid down for certain animals and goods intended for human consum ption, to ensure that third countr ies 
or regions thereof provide guarant ees on the efficiency of official controls on food safety as regards those animals 
and goods. Third countr ies or regions thereof should only appear on the lists laid down in Implementing 
Regulation (EU) 2021/405, after having provided evidence and guarantees that the animals and goods originating in 
them compl y with the Union requirements on food safety laid down in Regulations (EC) No 999/2001, (EC) 
No 178/2002, (EC) No 852/2004, (EC) No 853/2004, (EU) 2017/625, Delegat ed Regulation (EU) 2019/624 and 
Implementing Regulation (EU) 2019/627, or with requirements recognised to be equivalent thereto.
(12) Under Article 127(3) of Regulation (EU) 2017/625, the Commission may subject the decision to include third 
countr ies in lists laid down in Implementing Regulation (EU) 2021/405 to the provision, by those third countr ies, 
of appropr iate evidence and guarant ees of compl iance with the Union requirements on the use of phar macologically 
active substances in food-producing animals and of the compliance of consignments of products of animal origin 
and compo site products intende d to enter into the Union with the maximum residue limits of phar macologically 
active substances, maximum residue levels of pesticides and maximum levels of contaminants established in Union 
legislation. This ensures that those food-producing animals, products of animal origin and compo site products offer 
the same level of health protection as the one provi ded for by Union legislation on food and food safety .
(13) To ensure that same level of health prote ction, evidence and guarant ees should be provi ded by submitting a 
phar macological substance, pesticide and contaminant control plan that meets certain requirements provided for in 
this Regulation. To ensure continuous compl iance with those requirements, update d control plans should be 
submitted to the Commission on a yearly basis.
(14) Third countr ies may also be included in the list laid down in Annex -I to Implementing Regulation (EU) 2021/405 if 
they provide appropr iate evidence and guarant ees that the food-producing animals and products of animal origin, 
including those used in composit e products enteri ng the Union, originat e in a Member State or a third countr y 
included in a list of third countr ies with approved control plan for phar macologically active substances, pesticides 
and contaminants for those food-producing animals and products of animal origin, including those used in 
compo site products. Information on the procedures in place to ensure the traceability of the concer ned food- 
producing animals and products of animal origin and to guarant ee the origin of those animals and products should 
be provided to benefi t from that listing.
(11)Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff 
(OJ L 256, 7.9.1987, p. 1).
(12)Commission Implementing Regulation (EU) 2021/405 of 24 March 2021 laying down the lists of third countr ies or regions thereof 
author ised for the entr y into the Union of certain animals and goods intended for human consump tion in accordance with 
Regulation (EU) 2017/625 of the European Parliament and of the Council (OJ L 114, 31.3.2021, p. 118).EN Offi cial Jour nal of the European Union 24.11.2022 L 304/3  (15) Union legislation lays down rules on the use of phar macologically active substances and establishes limits for their 
residues in products of animal origin arising from such use. Food-producing animals and products of animal origin 
including those used in composit e products should only enter the Union from third countr ies ensur ing that 
controls on the use of phar macologically active substances and the residues thereof in products of animal origin are 
at least equivalent to those of the Union control plans included in the multi-annual national control plans refer red to 
in Commission Deleg ated Regulation (EU) 2022/1644 (13)and Commission Implementing Regulation (EU) 
2022/1646 (14). The rules laid down in Commission Implementing Regulation (EU) 2021/808 (15)should apply to 
the official controls on those substances and residues.
(16) The use, in food-producing animals in the Union, of beta-agonists and substances that have a hormonal or 
thyrosta tic action is prohibit ed under Directive 96/22/EC. Similarly , Commission Regulation (EU) No 37/2010 (16)
lists in Table 2 of the Annex to that Regulation phar macologically active substances that are prohibit ed for use in 
the Union. Only third countr ies that provide guarant ees that food-producing animals and products of animal origin, 
including those used in compo site products, compl y with these provisions or with requirements recognised to be 
equivalent thereto should be allowed to enter the Union such animals and such products.
(17) Regulation (EC) No 396/2005 of the European Parliament and of the Council (17)lays down a coordinated control 
programme of the Union on the maximum residue levels of pesticides in or on food and feed of plant and animal 
origin, with a view to assessing consumer exposure and the application of legislation in the EU. This Union control 
programme forms an integral part of the multiannual national control programmes for pesticides residues that 
Member State s are to establish. Food-producing animals and products of animal origin including those used in 
compo site products should only enter the Union from third countr ies, which ensure that controls on pesticide 
residues are carried out according to the same stringent criteria as those imposed on Member States through the 
multiannual national control programmes for pesticide residues set out in Commission Implementing Regulation 
(EU) 2021/1355 (18). It should thus be ensured that evidence is provided through statistically representative 
sampli ng that the products intended for entr y into the Union compl y with Union legislation on pesticide residues.
(13)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 veterinar y medicinal products or as feed additives and of prohibit ed or unauthor ised 
phar macologically active substances and residues thereof (OJ L 248, 26.9.2022, p. 3).
(14)Commission Implementing Regulation (EU) 2022/1646 of 23 September 2022 on unif orm practical arrangements for the 
perfor mance 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, on specific content of 
multi-annual national control plans and specific arrangements for their preparation (OJ L 248, 26.9.2022, p. 32).
(15)Commission Implementing Regulation (EU) 2021/808 of 22 March 2021 on the perf ormance 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 sampling and repealing Decisions 2002/657/EC and 98/179/EC (OJ L 180, 21.5.2021, p. 84).
(16)Commission Regulation (EU) No 37/2010 of 22 December 2009 on phar macologically active substances and their classific ation 
regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1).
(17)Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 Febr uary 2005 on maximum residue levels of 
pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).
(18)Commission Implementing Regulation (EU) 2021/1355 of 12 August 2021 on multiannual national control programmes for 
pesticides residues to be established by Member States (OJ L 291, 13.8.2021, p. 120).EN Offi cial Jour nal of the European Union L 304/4 24.11.2022  (18) Commission Delegat ed Regulation (EU) 2022/931 (19)and Commission Implemen ting Regulation (EU) 
2022/932 (20)provide for the establishment and the conte nt of risk-based control plans for contaminants in food. 
Products of animal origin and compo site products should only enter the Union from third countr ies, which ensure 
that controls on contaminants are carried out to provid e evidence that products of animal origin and composit e 
products intended for the entr y into the Union compl y with EU legislation on contaminants.
(19) Commission Decision 2011/163/EU (21)sets out, in accordance with Directive 96/23/EC, a list of third countr ies 
author ised for the entr y of certain animal species or products of animal origin into the Union.
(20) Following the repeal of Directive 96/23/EC, Commission Implementing Regulation (EU) 2022/2293 (22)replaced 
Decision 2011/163/EU in its entirety .
(21) Consignments of certain goods intended for human consump tion should only be allowed to enter the Union where 
those goods are dispatch ed from, and obtained or prepared in, establishments which appear on the list drawn up and 
kept up to date in accordance with Article 127(3), point (e)(ii), of Regulation (EU) 2017/625. In addition, in order to 
ensure compl iance with Union food hygiene rules, or with rules recognised to be at least equivalent thereto, it is 
appropr iate to provid e that, when drawing up and updating that list, the third countr y should provide additional 
guarant ees to those provid ed for in Article 127(3), points (e)(i) and (iv), of Regulation (EU) 2017/625.
(22) The lists of establishments refer red to in Article 127(3), point (e)(i), of Regulation (EU) 2017/625 should be made 
available to the public to ensure transparency for food business operat ors and consumers. To strengthen such 
transparency , Member States should only allow the entr y of consignments of animals and goods where the official 
certificates required for such consignments under the relevant Union rules are issued by the compet ent author ities 
of the third countr y after the publication of those lists.
(23) It is not necessar y to lay down such listing requirements as rega rds goods intende d for transit, since those goods 
represent a low risk from a food safet y perspective and are not placed on the mark et within the Union. Moreo ver, 
such requirements should not apply to establishments carrying out only primar y production activities, transpor t 
operations, storag e of products of animal origin not requir ing temperature-controlled storag e conditions or 
production of highly refined products of animal origin referred to in Section XVI of Annex III to Regulation (EC) 
No 853/2004.
(24) Commission Regulation (EU) No 210/2013 (23)requires establishments producing sprouts to be approved by the 
compet ent author ities in accordance with Article 6 of Regulation (EC) No 852/2004. In order to ensure compl iance 
with Union food hygiene rules, or with rules recognised to be at least equivalent theret o, sprouts should only be 
allowe d entr y into the Union if they are produced in establishments, which appear on lists drawn up and updat ed in 
accordance with this Regulation.
(19)Commission Delegat ed Regulation (EU) 2022/931 of 23 March 2022 supplementing Regulation (EU) 2017/625 of the European 
Parliament and of the Council by laying down rules for the perfor mance of official controls as regards contaminants in food 
(OJ L 162, 17.6.2022, p. 7).
(20)Commission Implementing Regulation (EU) 2022/932 of 9 June 2022 on unif orm practical arrangements for the perfor mance of 
official controls as regards contaminants in food, on specific additional content of multi-annual national control plans and specific 
additional arrangements for their preparation (OJ L 162, 17.6.2022, p. 13).
(21)Commission Decision 2011/163/EU of 16 March 2011 on the approval of plans submitt ed by third countr ies in accordance with 
Article 29 of Council Directive 96/23/EC (OJ L 70, 17.3.2011, p. 40).
(22)Commission Implementing Regulation (EU) 2022/2293 of 18 November 2022 amending Implementing Regulation (EU) 2021/405 
as regards the list of third countr ies with an approved control plan on the use of phar macologically active substances, the maximum 
residue limits of phar macologically active substances and pesticides and the maximum levels of contaminants (See page 31 of this 
Offi cial Jour nal).
(23)Commission Regulation (EU) No 210/2013 of 11 March 2013 on the approval of establishments producing sprouts pursuant to 
Regulation (EC) No 852/2004 of the European Parliament and of the Council (OJ L 68, 12.3.2013, p. 24).EN Offi cial Jour nal of the European Union 24.11.2022 L 304/5  (25) In order to ensure compl iance with Union food hygi ene rules, or with rules recognised to be at least equivalent 
thereto, products from establishments manufactur ing fresh meat, minced meat, meat preparations, meat products, 
mechani cally separated meat and raw mater ials intended for the production of gelatine and collagen should only be 
allowe d entr y into the Union if those establishments appear on lists drawn up and updat ed in accordance with 
Article 127(3), point (e)(ii), of Regulation (EU) 2017/625. In addition, the raw mat erials these products are 
manufact ured from should come from establishments (slaught erhouses, game-handling establishments, cutting 
plants and establishments handling fisher y products) appear ing on lists drawn up and updated in accordance with 
Article 127(3), point (e)(ii), of Regulation (EU) 2017/625.
(26) Consignments of live bivalve molluscs, echinode rms, tunicates and mar ine gastropods should only be allowe d entr y 
into the Union from production areas in third countr ies or regions thereof that appear on lists drawn up and 
update d in accordance with Article 127(3), point (e)(ii), of Regulation (EU) 2017/625 in order to ensure compl iance 
with the applicable specif ic requirements for these products laid down in Regulation (EC) No 853/2004 and 
Implementing Regulation (EU) 2019/627, or with rules recognised to be at least equivalent thereto. The publication 
of those lists should ensure transparency for food business operat ors and consumers as regards the production areas 
from whic h live bivalve molluscs, echi noder ms, tunicates and mar ine gastropods are allowed to enter the Union.
(27) Consignments of fisher y products should only be allowed to enter the Union where those consignments are 
dispatche d from, obtained or prepared in an on-land establishment, reefe r, factor y or freezer vessels flying the flag 
of a third countr y that appears on lists drawn up and update d in accordance with Article 127(3), point (e)(ii), of 
Regulation (EU) 2017/625 in order to ensure compliance with Union requirements, in particular with the specifi c 
requirements for fisher y products laid down in Regulation (EC) No 853/2004 and Implementing Regulation (EU) 
2019/627, or with rules recognised to be at least equivalent thereto. The publication of such lists should ensure 
transparency for food business operat ors and consumers as rega rds the vessels whose fisher y products may enter 
the Union.
(28) The risk associated with compo site products depends on the type of ingredients thereof and on the conditions of 
storag e of those ingredients. Requirements on the consignments of compo site products should theref ore be laid 
down , to ensure that the composit e products presenting a risk enter the Union from third countr ies author ised for 
entr y into the Union pursuant to Implementing Regulation (EU) 2021/405. Composit e products presenting a risk 
are those that contain processed products of animal origin, for whic h specifi c requirements are laid down in Annex 
III to Regulation (EC) No 853/2004, or for whic h a residue-monitor ing plan is required.
(29) Given the number of notifi cations received in the Rapid Aler t System for Food and Feed established by Regulation 
(EC) No 178/2002, the consignments of certain animals and goods intended to be placed on the market for human 
consum ption present an enhanced risk of non-com pliance with Union requirements on food safety . The 
consignments of such animals and goods should theref ore be subject to individual certification for each 
consignment prior to the entr y into the Union. That certification also contr ibutes to reminding food business 
operat ors and the compet ent author ities of third countr ies or regions thereof of the relevant Union requirements. 
Commission Implementing Regulation (EU) 2020/2235 (24)lays down model animal health certificates or model 
official certificates or both for that purpose. Consignments for such animals and goods for which the Union is not 
the final destination should be accompan ied by animal health certificates or official certificates with animal health 
attes tation, whilst public health attestation for those animals and goods is not needed, since they will not be placed 
on the mark et in the Union. As regards certain compo site products, whic h present a low risk, private attestation by 
the food business operat or entering goods into the Union should replace the certification to ensure a propor tionat e, 
risk-based approach .
(24)Commission Implementing Regulation (EU) 2020/2235 of 16 December 2020 laying down rules for the application of Regulations 
(EU) 2016/429 and (EU) 2017/625 of the European Parliament and of the Council as regards model animal health certificates, model 
official certificates and model animal health/offic ial certificates, for the entr y into the Union and movements within the Union of 
consignments of certain categor ies of animals and goods, official certification regar ding such certificates and repealing Regulation (EC) 
No 599/2004, Implementing Regulations (EU) No 636/2014 and (EU) 2019/628, Directive 98/68/EC and Decisions 2000/572/EC, 
2003/779/EC and 2007/240/EC (OJ L 442, 30.12.2020, p. 1).EN Offi cial Jour nal of the European Union L 304/6 24.11.2022  (30) Shelf-stable compo site products representing a negligible risk, such as those where the only animal product present 
in the final compo site product are food improvement agents, namely vitamin D3, food additives, food enzymes or 
food flavouri ngs, should be exem pted from controls at the borders and from private attes tation requirements.
(31) The provi sions of this Regulation aim to replace entirely those of Delegat ed Regulation (EU) 2019/625. Deleg ated 
Regulation (EU) 2019/625 should theref ore be repealed.
(32) As Annexes I, II, III and IV to Directive 96/23/EC cease to apply on 14 December 2022 , this Regulation should apply 
from 15 December 2022 ,
HAS ADOPTED THIS REGUL ATION:
CHA PTER I
SCOPE AND DEFINITIONS
Article 1
Subject matter and scope
1. This Regulation supplements Regulation (EU) 2017/625 as regards the requirements for the entr y in the Union of 
consignments of food-producing animals and certain goods intended for human consum ption from third countr ies or 
regions thereof in order to ensure that they compl y with the applicable requirements established by the rules referred to in 
Article 1(2), point (a), of Regulation (EU) 2017/625 or with requirements recognised to be at least equivalent thereto.
2. The requirements refer red to in paragraph 1 cover:
(a) the identif ication of food-producing animals and certain goods intended for human consum ption subject to the 
followi ng requirements for entr y into the Union:
(i) the requirement that those food-producing animals and certain goods intended for human consump tion shall 
come from a third countr y or region thereof listed in accordance with Article 126(2), point (a), of Regulation (EU) 
2017/625;
(ii) the requirement that those food-producing animals and certain goods intended for human consum ption be 
dispatched from, and obtained or prepared in, establishments which comply with applicable requirements 
refer red to in Article 126(1) of Regulation (EU) 2017/625, or with requirements recognised to be at least 
equivalent thereto, and whic h appear on lists drawn up and updated in accordance with Article 127(3), points (e) 
(ii) and (iii), of Regulation (EU) 2017/625;
(iii) the requirement that each consignment of food-producing animals and certain goods intended for human 
consump tion be accompan ied, by an official certificate, or official attes tation or any other evidence of compl iance 
with the rules refer red to in Article 1(2), point (a), of Regulation (EU) 2017/625, such as a private attestation, in 
accordance with Article 126(2), point (c), of Regulation (EU) 2017/625;
(b) requirements for the entr y into the Union of food-producing animals and certain goods intended for human 
consump tion from a third countr y or region thereof, listed in accordance with Article 127(2) of Regulation (EU) 
2017/625;
(c) requirements that consignments of food-producing animals and certain goods intended for human consum ption from 
third countr ies be dispatched from, and obtained or prepared in, establishments which comply with the applicable 
requirements refer red to in Article 126(1) of Regulation (EU) 2017/625, or with requirements recognised to be at least 
equivalent thereto, and whic h appear on lists drawn up and updat ed in accordance with Article 127(3), points (e)(ii)and 
(iii) of Regulation (EU) 2017/625;EN Offi cial Jour nal of the European Union 24.11.2022 L 304/7  (d) requirements for the entr y into the Union for placing on the market of the specifi c following commodities in addition 
to the requirements laid down in accordance with Article 126 of Regulation (EU) 2017/625:
(i) fresh meat, minced meat, meat preparations, meat products, mecha nically separate d meat and raw mat erials 
intended for the production of gelat ine and collagen;
(ii) live bivalve molluscs, echinoder ms, tunicat es and mar ine gastropods;
(iii) fisher y products;
(iv) compo site products;
(e) additional requirements for the official certificates, official attestations and private attestations that shall accompan y 
food-producing animals and certain goods intended for human consump tion for entr y into the Union;
(f) requirements for the use of phar macologically active substances in food-producing animals and the residues thereof 
and for the levels of contaminants and pesticide residues in products of animal origin and compo site products, where 
those food-producing animals, products of animal origin and composit e products enter the Union from third 
countr ies and are intende d to be placed on the mark et of the Union, and those requirements are necessar y to ensure 
that such food-producing animals, products of animal origin and compo site products provi de a level of human health 
protection equivalent to that provid ed by the relevant Union rules on food safety ;
(g) the requirement that food-producing animals, products of animal origin and composit e products shall only enter the 
Union from third countr ies that provide evidence and guarant ees of compliance with the requirements set out in this 
Regulation by submitting a control plan.
3. This Regulation shall not apply to:
(a) animals and goods not intended for human consump tion, however when the destination of the animals and goods has 
not been decided on entr y into the Union and intention for human consump tion cannot yet be excluded, this 
Regulation applies;
(b) animals and goods intende d for human consump tion only for transit through the Union without being placed on the 
market ;
(c) goods intended for human consum ption for the purpose of sam ples for product analysis and quality testing without 
being placed on the mark et.
Article 2
Def initions
For the purposes of this Regulation, the followi ng definitions shall apply:
(1) ‘ente ring the Union’ or ‘entr y into the Union’ means entering the Union or entr y into the Union as defined in Article 3, 
point (40), of Regulation (EU) 2017/625;
(2) ‘consignment’ means consignment as defined in Article 3, point (37), of Regulation (EU) 2017/625;
(3) ‘animals ’ means animals as defined in Article 3, point (9), of Regulation (EU) 2017/625;
(4) ‘goods’ means goods as defined in Article 3, point (11), of Regulation (EU) 2017/625;
(5) ‘equivalent’ means equivalent as defined in Article 2(1), point (e), of Regulation (EC) No 852/2004;
(6) ‘establishment’ means an establishment as defined in Article 2(1), point (c), of Regulation (EC) No 852/2004;
(7) ‘official certificate’ means official certificate as defined in Article 3, point (27), of Regulation (EU) 2017/625;
(8) ‘official attestation’ means official attestation as defined in Article 3, point (28), of Regulation (EU) 2017/625;EN Offi cial Jour nal of the European Union L 304/8 24.11.2022  (9) ‘private attestation’ means an attestation signed by the food business operat or enteri ng goods into the Union;
(10) ‘placing on the mark et’ means placing on the market as defined in Article 3, point (8), of Regulation (EC) 
No 178/2002;
(11) ‘fresh meat’ means fresh meat as defined in point 1.10 of Annex I to Regulation (EC) No 853/2004;
(12) ‘minced meat’ means minced meat as defined in point 1.13 of Annex I to Regulation (EC) No 853/2004;
(13) ‘meat preparations’ means meat preparations as defined in point 1.15 of Annex I to Regulation (EC) No 853/2004;
(14) ‘meat products’ means meat products as defined in point 7.1 of Annex I to Regulation (EC) No 853/2004;
(15) ‘mec hanically separated meat’ means mechani cally separate d meat as defined in point 1.14 of Annex I to Regulation 
(EC) No 853/2004;
(16) ‘gelatine’ means gelatine as defined in point 7.7 of Annex I to Regulation (EC) No 853/2004;
(17) ‘collag en’ means collagen as defined in point 7.8 of Annex I to Regulation (EC) No 853/2004;
(18) ‘highly refined products of animal origin’ means highly refined products refer red to in Section XVI, point 1, of Annex 
III to Regulation (EC) No 853/2004;
(19) ‘bivalve molluscs ’ means bivalve molluscs as defined in point 2.1 of Annex I to Regulation (EC) No 853/2004;
(20) ‘fisher y products’ means fisher y products as defined in point 3.1 of Annex I to Regulation (EC) No 853/2004;
(21) ‘comp osite product’ means food containing both products of plant origin and processed products of animal origin;
(22) ‘phar macologically active substance’ means phar macologically active substance as defined in Article 2, point (a), of 
Commission Deleg ated Regulation (EU) 2019/2090 (25);
(23) ‘contaminant’ means contaminant as defined in Article 1(1), second subparagraph, of Council Regulation (EEC) 
No 315/93 (26);
(24) ‘pesticide residues’ means pesticide residues as defined in Article 3(2), point (c), of Regulation (EC) No 396/2005;
(25) ‘product of animal origin’ means product of animal origin as defined in point 8.1 of Annex I to Regulation (EC) 
No 853/2004;
(26) ‘control plan for phar macologically active substances, pesticides and contaminants’ means a control plan on the use 
of phar macologically active substances, the maximum residue limits of phar macologically active substances, the 
maximum residue levels of pesticides and the maximum levels of contaminants in food-producing animals, products 
of animal origin, including those used in compo site products;
(25)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-compl iance 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).
(26)Council Regulation (EEC) No 315/93 of 8 Febr uary 1993 laying down Community procedures for contaminants in food (OJ L 37, 
13.2.1993, p. 1).EN Offi cial Jour nal of the European Union 24.11.2022 L 304/9  (27) ‘insects’ means food consisting of, isolat ed from or produced from insects or their parts including any life stadia of 
insects intended for human consump tion whic h are, when applicable, author ised in accordance with Regulation (EU) 
2015/2283 of the European Parliament and of the Council (27)and included in the Union list of novel foods 
established by Commission Implementing Regulation (EU) 2017/2470 (28)(‘the Union list of novel foods ’);
(28) ‘transit’ means transit as defined in Article 3, point (44), of Regulation (EU) 2017/625;
(29) ‘repti le meat’ means the edible parts, either unpro cessed or processed, derived from farmed reptiles, belonging to the 
species Allig ator mississippiensis, Crocody lus johnstoni, Crocodylus niloticus, Crocody lus poro sus, Timon lepidus, Python 
reticulatus, Python molur us bivittatus or Pelodiscus sinensis, which are, when applicable, author ised in accordance with 
Regulation (EU) 2015/2283 and included in the Union list of novel foods;
(30) ‘snails’ means snails as defined in point 6.2 of Annex I to Regulation (EC) No 853/2004 and any other species of snails 
of the family of Helicidae, Hyg romiidae or Sphincterochilidae, intended for human consum ption;
(31) ‘food’ means food as defined in Article 2 of Regulation (EC) No 178/2002;
(32) ‘feed’ or ‘feedingstuff’ means feed or feedingstuff as defined in Article 3, point (4), of Regulation (EC) No 178/2002;
(33) ‘audit’ means audit as defined in Article 3, point (30), of Regulation (EU) 2017/625;
(34) ‘comp etent author ities’ means compet ent author ities as defined in Article 3, point (3), of Regulation (EU) 2017/625;
(35) ‘sprouts’ means sprouts as defined in Article 2, point (a), of Commission Imple menting Regulation (EU) 
No 208/2013 (29);
(36) ‘primar y production’ means primar y production as defined in Article 3, point (17), of Regulation (EC) No 178/2002;
(37) ‘slaughte rhouse’ means slaughterhouse as defined in point 1.16 of Annex I to Regulation (EC) No 853/2004;
(38) ‘game -handling establishment’ means gam e-handling establishment as defined in point 1.18 of Annex I to Regulation 
(EC) No 853/2004;
(39) ‘cutting plant’ means cutting plant as defined in point 1.17 of Annex I to Regulation (EC) No 853/2004;
(40) ‘production area’ means production area as defined in point 2.5 of Annex I to Regulation (EC) No 853/2004;
(41) ‘fact ory vessel’ means factory vessel as defined in point 3.2 of Annex I to Regulation (EC) No 853/2004;
(42) ‘freezer vessel’ means freezer vessel as defined in point 3.3 of Annex I to Regulation (EC) No 853/2004;
(43) ‘reefer vessel’ means a vessel equipped to store and transpor t palletised or loose cargo (bulk) goods in temperature- 
controlled holds or chambers;
(44) ‘dair y products’ means dair y products as defined in point 7.2 of Annex I to Regulation (EC) No 853/2004;
(45) ‘egg products’ means egg products as defined in point 7.3 of Annex I to Regulation (EC) No 853/2004;
(27)Regulation (EU) 2015/2283 of the European Parliament of the Council of 25 November 2015 on novel foods, amending Regulation 
(EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European 
Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (OJ L 327, 11.12.2015, p. 1).
(28)Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in 
accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel food (OJ L 351, 30.12.2017, 
p. 72).
(29)Commission Implementing Regulation (EU) No 208/2013 of 11 March 2013 on traceability requirements for sprouts and seeds 
intended for the production of sprouts (OJ L 68, 12.3.2013, p. 16).EN Offi cial Jour nal of the European Union L 304/10 24.11.2022  (46) ‘food business operator ’ means a food business operator as defined in Article 3, point (3), of Regulation (EC) 
No 178/2002.
(47) ‘operator ’ means operat or as defined in Article 3, point (29), of Regulation (EU) 2017/625;
(48) ‘border control post ’ means border control post as defined in Article 3, point (38), of Regulation (EU) 2017/625.
CHAPTER II
CONDITIONS FOR THE ENTR Y INTO THE UNION AS REGARDS THIRD COU NTRIES OF ORIGIN OR REGIONS THEREOF
Article 3
Food-producing animals and goods which are required to come from third countr ies or regions thereof that are 
included in the list referred to in Article 126(2), point (a), of Regulation (EU) 2017/625
Consignments of the followi ng food-producing animals and goods intended for human consum ption shall enter the Union 
only from a third countr y or region thereof included in the list for those animals and goods laid down in Implementing 
Regulation (EU) 2021/405:
(a) live animals for whic h Combined Nomenclature codes (‘CN codes’ ) have been laid down in Part Two, Chapt er 1, of 
Annex I to Regulation (EEC) No 2658/87, where those live animals are food-producing animals;
(b) products of animal origin, including reptile meat and dead whole insects, parts of insects or processed insects, intende d 
for human consum ption, for which the followi ng codes have been laid down in Part Two of Annex I to Regulation 
(EEC) No 2658/87:
(i) CN codes in Chapt ers 2 to 5, 15, 16 or 29; or
(ii) Harmonised Syste m headings (‘HS headings’ ) 0901 , 1702 , 2105 , 2106 , 2301 , 3001 , 3002 , 3302 , 3501 , 3502 , 
3503 , 3504 , 3507 , 3913 , 3926 , 4101 , 4102 , 4103 or 9602 ;
(c) live snails, other than sea snails, refer red to by the CN code 0307 60 00of Part Two of Annex I to Regulation (EEC) 
No 2658/87;
(d) pollen flour falling under the CN code ex 1212 99 95of Part Two of Annex I to Regulation (EEC) No 2658/87.
Article 4
Additional requirements for the entr y into the Union of food-producing animals and goods from a third countr y 
or region thereof
In addition to the requirements laid down in Article 127(3) of Regulation (EU) 2017/625, the Commission shall only 
decide on the inclusion of third countr ies or regions thereof in the list refer red to in Article 126(2), point (a), of that 
Regulation if the follo wing requirements are recognised by the Commission as being at least equivalent to the relevant 
requirements in the Union for the food-producing animals and goods refer red to in Article 3 of this Regulation:
(a) the legislation of the third countr y on:
(i) the production of products of animal origin;
(ii) the use of veteri nary medicinal products, including rules on their prohibition or author isation, their distr ibution, 
their placing on the mark et and the rules covering administration and inspection;
(iii) the preparation and use of feed, including the procedures for using additives and the preparation and use of 
medicated feedingstuffs, as well as the hygi ene quality of the raw mater ials used for prepar ing feedingstuffs and of 
the final product ;EN Offi cial Jour nal of the European Union 24.11.2022 L 304/11  (b) the hygiene conditions of production, manufa cture, handling, storag e and dispatch currently applied to products of 
animal origin destined for the Union;
(c) any exper ience of mark eting of the products of animal origin from the third countr y and the results of any official 
controls on entr y in the Union;
(d) when available, the results of audits carried out by the Commission in the third countr y relat ed to other food-producing 
animals and goods for which the third countr y is already listed in accordance with Article 127(2) of Regulation (EU) 
2017/625, in particular the results of the assessment of the compet ent author ities in the third countr y audited , and 
the action that the compet ent author ities have taken in the light of any recommendations addressed to them followi ng 
such audits by the Commission;
(e) the existence, implementation and communication of a zoonoses control programme approved by the Commission 
when applicable;
(f) the third countr y’s requirements as regards phar macologically active substances, pesticides and contaminants, in 
accordance with Article 6.
Article 5
Animals and products to which Articles 6 to 12 apply
1. The requirements laid down in Articles 6 to 12 shall apply to the following animals and products:
(a) live animals for which CN codes have been laid down in Part Two, Section 1, Chapt er 1, of Annex I to Regulation (EEC) 
No 2658/87, where those animals are food-producing animals;
(b) products of animal origin, for which CN codes have been laid down in Part Two, Chapt ers 2 to 5, 15 and 16 of Annex I 
to Regulation (EEC) No 2658/87, and for which Harmonised System subheadings (‘HS subheadings ’) have been laid 
down under HS headings 0901 , 2105 , 3501 , 3502 and 3504 ;
(c) composit e products for which CN codes have been laid down in Part Two, Section III, Chapt er 15, and Section IV, 
Chapt ers 16 to 22, of Annex I to Regulation (EEC) No 2658/87.
2. The requirements laid down in Articles 6 to 12 shall not apply to
— gelatine and to raw mater ials for the production of gelatine, referred to in Section XIV, Chapt er I, point 1, of Annex III to 
Regulation (EC) No 853/2004, and
— collagen and to raw mater ials for the production of collagen , referred to in Section XV, Chapt er I, point 1, of Annex III 
to that Regulation, and
— highly refined products of animal origin, and
— insects, frogs, frogs’ legs, snails, reptiles and reptile meat.
Article 6
Additional requirements for the entr y into the Union of food-producing animals, products of animal origin and 
composite products, as regards phar macologically activ e subst ances and residues thereof, cont aminants and 
pest icide residues
1. In addition to the requirements laid down in Regulation (EU) 2017/625, consignments of food-producing animals, 
products of animal origin and composit e products shall enter the Union only from a third countr y that has in place a 
control plan for phar macologically active substances, pesticides and contaminants setting out guarant ees as regar ds 
compl iance with:
(a) the Union requirements on the use of phar macologically active substances, the maximum residue limits of 
phar macologically active substances, maximum residue levels of pesticides and maximum levels of contaminants; and
(b) the additional requirements specif ied in Articles 9 to 12 of this Regulation.EN Offi cial Jour nal of the European Union L 304/12 24.11.2022  2. In addition to the requirements laid down in Article 127(3) of Regulation (EU) 2017/625, the Commission shall 
decide on the inclusion of a third countr y in the list referred to in Article 126(2), point (a), of that Regulation only if that 
third countr y provid es evidence and guarant ees of compl iance with the requirements laid down in paragraph 1 of this 
Article, together with the information listed in Part II of Annex I to this Regulation, in the request for inclusion in the list 
of third countr ies whic h that third countr y is to submit under Article 127(2) of Regulation (EU) 2017/625.
3. After having appro ved the inclusion of the third countr y in the list of author ised third countr ies, the Commission 
shall ensure, in accordance with Article 127(3) of Regulation (EU) 2017/625, that the third countr y continues to compl y 
with the requirements laid down in paragraph 1 of this Article.
4. For the purposes of paragraph 3, the Commission shall take into account the updat ed evidence and guarantees of 
compl iance with the requirements laid down in paragraph 1, including the required information on the third countr y’s 
control plan for phar macologically active substances, pesticides and contaminants in accordance with Part II of Annex I, to 
be submitted by that third countr y by 31 March of each year.
Article 7
Inclusion of a third countr y in a list of third countr ies that comply with Union requirements on 
phar macologically activ e subst ances and residues thereof, contaminants and pesticide residues
In addition to the conditions laid down in Regulation (EU) 2017/625, consignments of food-producing animals, products 
of animal origin and compo site products, shall enter the Union only from a third countr y that compl ies with the 
requirements provid ed for in Article 6(1) and is included in the list of third countr ies approved for the entr y into the 
Union of the concer ned food-producing animals or products of animal origin, set out in Annex -I to Implementing 
Regulation (EU) 2021/405.
Article 8
Derogation from the requirements for the entr y into the Union of food-producing animals, products of animal 
origin and composite products
1. By way of derogat ion from Article 7, consignments of food-producing animals, products of animal origin and 
compo site products may enter the Union from third countr ies that do not have an approved control plan for 
phar macologically active substances, pesticides and contaminants but ensure that the food-producing animals and 
products of animal origin, including those used in compo site products, originate in a Member State or a third countr y 
included in the list set out in Annex -I to Implementing Regulation (EU) 2021/405 as regards those food-producing 
animals or products of animal origin.
2. In addition to the requirements laid down in Article 127(3) of Regulation (EU) 2017/625, the Commission shall 
decide on the inclusion of a third countr y in the list referred to in Article 126(2), point (a), of that Regulation only if the 
compet ent author ity of that third countr y provides the Commission with evidence and guarantees of compliance with the 
requirements laid down in paragraph 1 of this Article. Such evidence and guarant ees shall consist of information on the 
procedures in place in that third countr y to guarantee the traceability and origin of those food-producing animals and 
those products of animal origin.
3. Where a third countr y is included, in accordance with paragraphs (1) and (2), in the list of author ised third countr ies 
for specifi c food-producing animals or products of animal origin, the entr y for that third countr y shall be accompan ied by 
the follo wing note:EN Offi cial Jour nal of the European Union 24.11.2022 L 304/13  ‘Third countr y, only entering the Union specifi c food-producing animals or products of animal origin – as such or as 
ingredients of compo site products –, whic h originat e (a) from other third countr ies author ised for the entr y into the Union 
of such food-producing animals or products of animal origin; or (b) from Member States, in accordance with Article 8 of 
Commission Delega ted Regulation (EU) 2022/2292.’.
For third countr ies that, because of animal health requirements, may not enter the Union specific food-producing animals 
or products of animal origin as such, the entr y for that third countr y shall be accompan ied by the follo wing note:
‘Third countr y, only entering the Union compo site products containing processed products of animal origin, which 
originate (a) from other third countr ies author ised for the entr y into the Union of such products of animal origin; or (b) 
from Member States, in accordance with Article 8 of Commission Deleg ated Regulation (EU) 2022/2292.’.
4. For the production of casings intended for entr y into the Union, third countr ies may use raw mat erials of animal 
origin sourced from Member States or from other third countr ies or regions thereof which are author ised for the entr y 
into the Union of fresh meat, or of certain meat products and treated stoma chs, bladders and intestines, and which are 
liste d in the relevant lists of such fresh meat and meat products of Commission Implementing Regulation (EU) 
2021/404 (30)or Implementing Regulation (EU) 2021/405. Third countr ies entering the Union casings shall be listed in 
Annex -I to Imple menting Regulation (EU) 2021/405 for casings. In addition, the establishments from whic h the casings 
are to be entered the Union shall be listed in accordance with Article 13(1) of this Regulation.
5. After having approved the inclusion of the third countr y in the lists of author ised third countr ies referred to in this 
Article, the Commission shall ensure, in accordance with Article 127(4) of Regulation (EU) 2017/625, that the third 
countr y continues to comply with the requirements laid down in paragraph 1 of this Article.
CHA PTER III
CONDITIONS FOR THE ENTR Y INTO THE UNION AS REGARDS THE USE OF PHARMA COL OGIC ALL Y ACTIVE 
SUBST ANCES AND RESIDUES THEREOF, CONT AMINANTS AND PESTICIDE RESIDUES
Article 9
Requirements as regards the use of phar macologically activ e subst ances in food-producing animals and residues 
thereof in products of animal origin and composite products
1. Food-producing animals, products of animal origin and compo site products shall only enter the Union from third 
countr ies which provi de guarant ees that the controls on the use of phar macologically active substances refer red to in 
Annex I to Delegat ed Regulation (EU) 2022/1644 and on the residues thereof are at least equivalent to those required for 
the multiannual national control plans of Member States referred to in Article 4 of Imp lementing Regulation (EU) 
2022/1646.
2. Where a third countr y author ises the use in food-producing animals of phar macologically active substances which 
are not author ised for such animals in the Union, food-producing animals, products of animal origin and composit e 
products shall only enter the Union insof ar as that third countr y provid es guarant ees that No residues thereof are present 
in those animals and products. The methods of analysis used to demonstrate the absence of such residues shall compl y 
with the requirements laid down in Annex I to Imp lementing Regulation (EU) 2021/808 or with requirements equivalent 
thereto.
(30)Commission Implementing Regulation (EU) 2021/404 of 24 March 2021 laying down the lists of third countr ies, territories or zones 
thereof from which the entr y into the Union of animals, germinal products and products of animal origin is permitt ed in accordance 
with Regulation (EU) 2016/429 of the European Parliament and of the Council (OJ L 114, 31.3.2021, p. 1).EN Offi cial Jour nal of the European Union L 304/14 24.11.2022  Article 10
Requirements as regards the prohibition of certain subst ances
1. Food-producing animals, products of animal origin and compo site products shall only enter the Union from third 
countr ies which provi de guarant ees of compl iance with the prohibition of the use of beta-agonists and any stilbene, 
thyrosta tic, oestrogenic, androg enic and gestag enic substances in farm animals laid down in Directive 96/22/EC, and with 
the prohibition of the use of the substances listed in Table 2 of the Annex to Regulation (EU) No 37/2010.
2. Food-producing animals, products of animal origin and compo site products from third countr ies that author ise the 
use of the substances refer red to in paragraph 1 in food-producing animals or do not have rules on the use of those 
substances shall only enter the Union insofar as those third countr ies provide guarant ees that:
(a) they have set up a segregat ed production syste m to ensure that food-producing animals, products of animal origin and 
composit e products intended for entr y into the Union are not treated with the substances refer red to in paragraph 1; 
and
(b) they have set up an appropr iate animal identification and traceability system , as well as a system for the control of the 
distr ibution of the substances referred to in paragraph 1 and for the record keeping of the administration of veterinar y 
medicinal products.
Article 11
Requirements as regards residues of pesti cides in products of animal origin and composite products
Products of animal origin and composit e products shall only enter the Union from third countr ies which provide 
guarant ees that representative controls on pesticide residues are performe d in order to demonstrate that those products 
compl y with the maximum residue levels laid down in Regulation (EC) No 396/2005. Those guarant ees shall be at least 
equivalent to those provided for by the multiannual national control programmes for pesticide residues refer red to in 
Implementing Regulation (EU) 2021/1355.
Article 12
Requirements as regards contaminants in products of animal origin and composite products
Products of animal origin and composit e products shall only enter the Union from third countr ies which provide 
guarant ees that those products compl y with the maximum tolerances for contaminants established on the basis of 
Regulation (EEC) No 315/93. Those guarant ees shall be at least equivalent to those provid ed for by the multiannual 
national control plans established in accordance with Deleg ated Regulation (EU) 2022/931 and Implementing Regulation 
(EU) 2022/932.
CHA PTER IV
CONDITIONS FOR THE ENTR Y INTO THE UNION AS REGARDS EST ABLISHMENTS
Article 13
Requirements for establishments
1. Consignments of the followi ng goods shall only enter the Union where those consignments are dispatch ed from, and 
obtained or prepared in, establishments that appear on lists drawn up and kept up-to -date in accordance with Article 
127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625:EN Offi cial Jour nal of the European Union 24.11.2022 L 304/15  (a) products of animal origin, for whic h requirements are laid down in Annex III to Regulation (EC) No 853/2004, and for 
which the followi ng codes have been laid down in Part Two of Annex I to Regulation (EEC) No 2658/87:
(i) CN codes in Chapt ers 2 to 5, 15 or 16; or
(ii) HS subheadings under headings 1702 , 2105 , 2106 , 2301 , 2932 , 3001 , 3002 , 3501 , 3502 , 3503 , 3504 , 4101 , 
4102 or 4103 ;
(b) sprouts falling under the follo wing HS subheadings: 0704 90, 0706 90, 0708 10, 0708 20, 0708 90or 1214 90of 
Part Two of Annex I to Regulation (EEC) No 2658/87.
2. Establishments referred to in paragraph 1 of this Article may be placed on the lists refer red to in Article 127(3), point 
(e), of Regulation (EU) 2017/625 only if, in addition to the guarant ees laid down in Article 127(3), points (e)(ii) and (iv), of 
Regulation (EU) 2017/625, the third countr y where the establishments are located provi des the followi ng guarant ees:
(a) such establishments, together with any establishments handling raw mat erials of animal origin used in the manufacture 
of the products of animal origin referred to in paragraph 1(a), comply with applicable requirements refer red to in 
Article 126(1) of Regulation (EU) 2017/625, in particular those of Regulation (EC) No 853/2004, or with 
requirements recognised to be at least equivalent thereto;
(b) such establishments, where appropr iate, only handle raw mater ials of animal origin that come from third countr ies 
with an appro ved residue monitoring plan for that product categor y in accordance with Delegat ed Regulation (EU) 
2022/1644 and Implementing Regulation (EU) 2022/1646, or from Member States;
(c) it has real powers to stop such establishments from entering the Union, products of animal origin in the event that the 
establishments fail to meet the relevant Union requirements or requirements recognised to be at least equivalent 
thereto.
3. The Commission shall provide the Member States with any new and updated lists that it receives from the compet ent 
author ities of the third countr y in accordance with Article 127(3), point (e)(iii), of Regulation (EU) 2017/625 and shall 
publish such lists on its website.
4. Member State s shall only allow the entr y into the Union of the consignments refer red to in paragraph 1 provided that 
the official certificates which are required to accompan y such consignments pursuant to applicable Union rules are issued 
by the compet ent author ities of the third countr y starting with the date of publication, by the Commission, of the lists of 
establishments referred to in paragraph 1.
Article 14
Establishments not subject to the requirements of Article 13(1)
The requirements laid down in Article 13(1) shall not apply to establishments that only carry out the followi ng activities:
(a) primar y production;
(b) transpor t operations;
(c) storag e of products of animal origin not requir ing temperature-controlled storag e conditions;
(d) production of highly refined products of animal origin refer red to by HS headings 2930 , 2932 , 3503 , 3507 or 3913 of 
Part Two of Annex I to Regulation (EEC) No 2658/87;
(e) production of gelatine capsules referred to by HS headings 3913 , 3926 or 9602 of Part Two of Annex I to Regulation 
(EEC) No 2658/87.EN Offi cial Jour nal of the European Union L 304/16 24.11.2022  CHA PTER V
ADDITIONAL REQUIREMENTS FOR THE ENTR Y INTO THE UNION OF CERT AIN GOODS INTENDED FOR HUMAN 
CONSUMPTION
Article 15
Requirements for consignments of fresh meat, minced meat, meat preparations, mechanically separated meat and 
meat products, and raw mater ials intended for the production of gelatine and collagen
Consignments of the follo wing products of animal origin shall only enter the Union if they have been manufa ctured from 
raw mat erials obtained in slaughterhous es, game-handling establishments, cutting plants and establishments handling 
fisher y products, appear ing on lists of establishments drawn up and kept up-to -date in accordance with Article 127(3), 
point (e), of Regulation (EU) 2017/625:
(a) fresh meat ;
(b) minced meat ;
(c) meat preparations;
(d) mechanically separated meat and meat products, excluding casings as defined in Article 2, point (45), of Commission 
Delegat ed Regulation (EU) 2020/692 (31);
(e) raw mate rials intended for the production of gelatine and collagen refer red to, respectively , in Section XIV, Chapt er I, 
point 4(a), and in Section XV, Chapt er I, point 4(a), of Annex III to Regulation (EC) No 853/2004.
Article 16
Requirements for consignments of live bivalv e molluscs, echinoder ms, tunicates and mar ine gastropods
1. Notwithstanding Article 14 of this Regulation, consignments of live bivalve molluscs, echinoder ms, tunicates and 
mar ine gastropods for which CN codes have been laid down under heading 0307 of Part Two of Annex I to Regulation 
(EEC) No 2658/87 shall enter the Union only from production areas in third countr ies that appear on lists drawn up by 
the compet ent author ities of the third countr y in accordance with Article 127(3), point (e), of Regulation (EU) 2017/625 
and published by the Commission.
2. The follo wing products may enter the Union, even if harvested in areas which have not been classified by the 
compet ent author ities in the third countr y of production in accordance with Article 18(6) of Regulation (EU) 2017/625:
(a) pectinidae, excep t where data from monit oring programmes established under Article 57 of Implementing Regulation 
(EU) 2019/627 enable the compe tent author ities to classify fishing grounds as provided for in Section VII, Chapt er IX, 
point 2, of Annex III to Regulation (EC) No 853/2004;
(b) mar ine gastropods that are not filter feeders and echi noder ms that are not filter feeders.
Article 17
Listing of production areas
1. Before the lists referred to in Article 16(1) of this Regulation are drawn up by the compet ent author ities of the third 
countr y, particular account shall be taken of the guarant ees that the compet ent author ities of the third countr y can give 
concer ning compl iance with the requirements of Article 52 of Imple menting Regulation (EU) 2019/627 on the 
classificat ion and control of production areas.
(31)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).EN Offi cial Jour nal of the European Union 24.11.2022 L 304/17  2. The Commission shall carry out an on-the-spot control visit before the lists refer red to in Article 16(1) are drawn up.
3. Once the lists refer red to in Article 16(1) are drawn up, and where the compet ent author ities of the third countr y 
offer sufficient guarant ees on the classificat ion and control of production areas under their responsibility , the on-the-spot 
Commission control visit does not need to be carried out prior to the addition of a new production area to an existing list 
established in accordance with Article 13.
Article 18
Special requirements for fisher y products
Consignments of fisher y products for which CN codes have been laid down under headings 0301 , 0302 , 0303 , 0304 , 
0305 , 0306 , 0307 , 0308 , 0309 , 1504 , 1516 , 1517 , 1603 , 1604 , 1605 or 2106 of Part Two of Annex I to Regulation 
(EEC) No 2658/87, shall enter the Union for placing on the mark et only if they have been obtained or prepared, at any 
stage of their production, in an on-land establishment, a factory or freezer vessel or store d in a cold-store or a reefe r vessel 
that appears on a list drawn up and updated in accordance with Article 127(3), point (e), of Regulation (EU) 2017/625 and 
published by the Commission.
Article 19
Special requirements for listing vessels
1. A vessel may be included in the lists of establishments referred to in Article 127(3), point (e)(ii), of Regulation (EU) 
2017/625 provided that the compet ent author ities of the third countr y whose flag the vessel is flying, and the compet ent 
author ities of another third countr y to which the compet ent author ities of the third countr y whose flag the vessel is flying 
have delegat ed responsibility for the inspection of the vessel concer ned, provi de the Commission with a joint 
communication stating that all of the follo wing requirements are met:
(a) both third countr ies appear on the list of third countr ies or regions thereof, drawn up in accordance with Article 
127(3) of Regulation (EU) 2017/625, from whic h entr y into the Union of fisher y products is permitted;
(b) all fisher y products from the vessel concer ned that are destined for placing on the market in the Union are landed 
directly in the third countr y to whic h the third countr y whose flag the vessel is flying has delegat ed responsibility for 
the inspection of the vessel concer ned;
(c) the delegat ed compet ent author ities have inspecte d the vessel and have declared that it complies with the applicable 
Union requirements;
(d) the delegat ed compet ent author ities have declared that they will regularly inspect the vessel to ensure that it continues 
to compl y with the applicable Union requirements.
2. A vessel may be included in the lists of establishments referred to in Article 127(3), point (e)(ii), of Regulation (EU) 
2017/625 on the basis of a joint communication from the compet ent author ities of the third countr y whose flag the 
vessel is flying and from the compet ent author ities of a Member State to which the compet ent author ities of the third 
countr y whose flag the vessel is flying have delega ted responsibility for the inspection of the vessel concer ned, if all of the 
follo wing requirements are met:
(a) all fisher y products from the vessel concer ned that are destined for placing on the market in the Union are landed 
directly in the Member State to whic h the third countr y whose flag the vessel is flying has delegat ed responsibility for 
the inspection of the vessel concer ned;
(b) the delegat ed compet ent author ities have inspecte d the vessel and have declared that it complies with the applicable 
Union requirements;
(c) the delegat ed compet ent author ities have declared that they will regularly inspect the vessel to ensure that it continues 
to compl y with the applicable Union requirements.EN Offi cial Jour nal of the European Union L 304/18 24.11.2022  Article 20
Requirements for consignments of composite products
1. Consignments of compo site products refer red to by the CN codes under headings 1517 , 1518 , 1601 00, 1602 , 
1603 00, 1604 , 1605 , 1702 , 1704 , 1806 , 1901 , 1902 , 1904 , 1905 , 2001 , 2004 , 2005 , 2008 , 2101 , 2103 , 2104 , 
2105 00, 2106 , 2202 or 2208 of Part Two of Annex I to Regulation (EEC) No 2658/87 shall enter the Union for placing 
on the market only if each processed product of animal origin contained in the composit e products was either produced in 
establishments that are located in third countr ies or regions thereof and author ised to enter the Union those processed 
products of animal origin in accordance with Article 13 of this Regulation or in establishments located in Member States.
2. Pending the establishment by the Commission of a specific list of third countr ies or regions thereof author ised to 
enter the Union composit e products, consignments of compo site products from third countr ies or regions thereof may 
enter the Union, subject to compl iance with the followi ng rules:
(a) composit e products referred to in paragraph 1 that need to be transpor ted or stored under controlled temperatures 
shall originate from third countr ies or regions thereof author ised, under Article 3, to enter the Union each processed 
product of animal origin contained in the composit e products;
(b) composit e products referred to in paragraph 1 that do not need to be transpor ted or stored under controlled 
temperatures and that contain any quantity of colostr um-based products or meat products, shall originate from third 
countr ies or regions thereof author ised, under Article 3, to enter the Union the colostr um-based products or meat 
products contained in the compo site products;
(c) composit e products referred to in paragraph 1 that do not need to be transpor ted or stored under controlled 
temperatures and that contain processed products of animal origin other than colostr um-based products or meat 
products, for which requirements are laid down in Annex III to Regulation (EC) No 853/2004, shall originat e from 
third countr ies or regions thereof that are author ised, under Article 3 of this Regulation, to enter the Union meat 
products, dair y products, fisher y products or egg products on the basis of Union animal and public health 
requirements and are listed at least for one of these products of animal origin.
3. The third countr ies or regions thereof enter ing the Union composit e products shall be liste d in Annex -I to 
Implementing Regulation (EU) 2021/405 as having an approved control plan, in accordance with Article 6 of this 
Regulation, for the species or commodities from which the processed products of animal origin contained in the 
compo site products, with the excep tion of collage n, gelat ine and highly refined products of animal origin, are derived.
4. Paragraphs 2 and 3 shall not apply to shelf-stable composit e products that only contain processed products of animal 
origin or compo site products that fall under the scope of Regulation (EC) No 1332/2008 of the European Parliament and of 
the Council (32), Regulation (EC) No 1333/2008 of the European Parliament and of the Council (33), Regulation (EC) 
No 1334/2008 of the European Parliament and of the Council (34), or that only contain vitamin D3.
(32)Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes and amending 
Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and 
Regulation (EC) No 258/97 (OJ L 354, 31.12.2008, p. 7).
(33)Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 
31.12.2008, p. 16).
(34)Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food 
ingredients with flavouring proper ties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) 
No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (OJ L 354, 31.12.2008, p. 34).EN Offi cial Jour nal of the European Union 24.11.2022 L 304/19  CHA PTER VI
CONDITIONS FOR THE ENTR Y INTO THE UNION AS REGARDS CERTIFICA TION AND ATTEST ATION
Article 21
Official certificates
1. Each consignment of the follo wing products shall enter the Union only where the consignment is accompan ied by an 
official certificate excep t in case of consignments for whic h the Union is not the final destination:
(a) live animals for which CN codes have been laid down in Part Two, Section I, Chapt er 1, of Annex I to Regulation (EEC) 
No 2658/87, where those live animals are food-producing animals;
(b) products of animal origin intended for human consump tion, for which the following codes have been laid down in Part 
Two of Annex I to Regulation (EEC) No 2658/87:
(i) CN codes in Chapt ers 2 to 5, 15, 16 or 29; or
(ii) HS headings 0901 , 1702 , 2105 , 2106 , 2301 , 3001 , 3002 , 3501 , 3502 , 3503 , 3504 , 3507 , 3913 , 3926 , 4101 , 
4102 , 4103 or 9602 ;
(c) sprouts and seeds intended for the production of sprouts and referred to by the followi ng HS subheadings: 0704 90, 
0706 90, 0708 10, 0708 20, 0708 90, 0712 34, 0712 35, 0712 50, 0712 60, 0713 10, 0713 33, 0712 34, 0713 39, 
0713 40, 0713 90, 0910 99, 1201 10, 1201 90, 1207 50, 1207 99, 1209 10, 1209 21, 1209 91or 1214 90of Part 
Two of Annex I to Regulation (EEC) No 2658/87;
(d) pollen flour refer red to by the CN code 1212 99 95of Part Two of Annex I to Regulation (EEC) No 2658/87;
(e) live snails, other than sea snails, refer red to by the CN code 0307 60 00of Part Two of Annex I to Regulation (EEC) 
No 2658/87;
(f) composit e products referred to in Article 20(2), points (a) and (b), of this Regulation, with the excl usion of shelf-stable 
composit e products that do not contain colostr um-based products or processed meat other than gelatine, collage n or 
highly refined products of animal origin.
2. When consignments of fisher y products enter the Union directly from a reefer , factor y or a freezer vessel flying the 
flag of a third countr y, the official certificate refer red to in Article 14(3) of Implementing Regulation (EU) 2020/2235 may 
be signed by the captain.
3. No official certificate is necessar y for the entr y into the Union of gelat ine capsules covered by HS headings 3913 , 
3926 or 9602 of Part Two of Annex I to Regulation (EEC) No 2658/87, where those capsules are not derived from 
ruminant bones.
4. The official certificates refer red to in paragraph 1 shall certify that the products compl y with:
(a) the requirements laid down in Regulations (EC) No 178/2002, (EC) No 852/2004 and (EC) No 853/2004 or provi sions 
recognised to be equivalent to those requirements;
(b) any specific requirements for entr y into the Union set out in this Regulation.
5. The official certificates refer red to in paragraph 1 may include details required in accordance with other Union 
legislation on public and animal health matters.
6. The official certificate for sprouts and seeds intende d for the production of sprouts refer red to in paragraph 1(c) shall 
accompan y the consignment until it reaches its destination as indicated in the official certificate. In the case of splitting of 
the consignment, a copy of the official certificate shall accompan y each part of the consignment.EN Offi cial Jour nal of the European Union L 304/20 24.11.2022  7. The compet ent author ities of the third countr y of dispatc h may certify consignments of products of animal origin 
that only require public health attestation, or consignments of sprouts, coming from another third countr y, if the 
compet ent author ities of the third countr y of dispatch can ensure compliance of the consignments with the requirements 
for entr y into the Union laid down in this Regulation.
Article 22
Private attest ation
1. A private attestation conf irming that the consignments comply with the applicable requirements refer red to in 
Article 126(2) of Regulation (EU) 2017/625, prepared and signed by the food business operat or entering goods into the 
Union, shall accompan y:
(a) the consignments of the compo site products refer red to in Article 20(2), point (b), of this Regulation, where the 
composit e products do not contain colostr um-based products or processed meat other than gelatine, collage n or 
highly refined products of animal origin; and
(b) the consignments of the compo site products refer red to in Article 20(2), point (c), of this Regulation.
2. By way of derogation from paragraph 1, for the compo site products exempted from official controls at border control 
posts, in accordance with Article 48, point (h), of Regulation (EU) 2017/625, the private attestation shall accompan y the 
compo site products at the time of the placing on the mark et.
3. The private attestation refer red to in paragraph 1 shall ensure the traceability of the consignments and shall include:
(a) information regarding the consignor and consignee of the goods entered into the Union;
(b) the list of products of plant origin and processed products of animal origin contained in the compo site products, 
indicated in descending order of weight, as recorded at the time of their use in the manuf acture of the compo site 
products;
(c) the approval number the establishment(s) manufact uring the processed products of animal origin contained in the 
composit e products was assigned upon being grant ed appro val under Article 4(3) of Regulation (EC) No 853/2004, 
indicated by the food business operator entering goods in the Union.
4. The private attestation refer red to in paragraph 1 shall attes t that:
(a) the third countr y or region thereof producing the compo site products is liste d at least for one of the following 
categor ies of products of animal origin:
(i) meat products;
(ii) dair y products or colostr um-based products;
(iii) fisher y products;
(iv) egg products;
(b) the establishment producing the compo site products fulfils hygiene standards recognised to be equivalent to those 
required by Regulation (EC) No 852/2004;
(c) the composit e products do not need to be stored or transpor ted under controlled temperature;
(d) the processed products of animal origin contained in the compo site products originate from third countr ies or regions 
thereof author ised to enter the Union each processed product of animal origin, or from the Member State s, and are 
sourced from listed establishments;
(e) the processed products of animal origin used in the compo site products have undergone at least one of the treatments 
refer red to in Article 163(1) of Deleg ated Regulation (EU) 2020/692, with a brief descr iption of any processes 
undergone and temperatures applied to the compo site products.EN Offi cial Jour nal of the European Union 24.11.2022 L 304/21  CHAPTER VII
FINAL PROVISIONS
Article 23
References
References to Article 29 of Directive 96/23/EC shall be constr ued as references to this Regulation.
Article 24
Repeal
Delegat ed Regulation (EU) 2019/625 is repealed.
References to the repealed Delegat ed Regulation shall be constr ued as references to this Regulation and shall be read in 
accordance with the correlation table in Annex II.
Article 25
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, 6 Sept ember 2022 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 304/22 24.11.2022  ANNEX I 
This Annex sets out the information on the control plan for phar macologically active substances, pesticides and 
contaminants and updat ed control plan for phar macologically active substances, pesticides and contaminants which a 
third countr y is to submit for the purpose of its inclusion and maintenanc e in the list refer red to in Article 7.
PART I
Gener al requir ements as regards the submission of the control plan for phar macologically activ e substances, pesticides 
and contaminants and the updated control plan for phar macologically activ e substances, pesticides and contaminants
1. The control plan for phar macologically active substances, pesticides and contaminants which a third countr y is to 
submit, together with the request for its inclusion in the list refer red to in Article 7 for specific food-producing 
animals or products of animal origin, shall include the information specified in Part II of this Annex.
2. After a third countr y is included in the list refer red to in point 1, it shall submit, for the purposes of being maintained 
on that list, an annually update d control plan for phar macologically active substances, pesticides and contaminants, 
with the information specif ied in Part III.
3. Additional information to compl ement the control plan for phar macologically active substances, pesticides and 
contaminants and updated control plan for phar macologically active substances, pesticides and contaminants referred 
to in points 1 and 2 may be provided anytime.
4. The relevant guidance documents as regards prohibit ed substances, residues of veteri nary medicinal products, pesticide 
residues and contaminants, made publicly available by the Commission shall be taken into account for the submission 
of the control plan for phar macologically active substances, pesticides and contaminants and updat ed control plan for 
phar macologically active substances, pesticides and contaminants.
5. The control plan for phar macologically active substances, pesticides and contaminants shall be sent to the Commission 
electronically , in the format descr ibed in the guidance documents referred to in point 4 or in another format, provided 
that it includes all of the information listed in Parts II and III, where applicable.
PART II
Thir d countr y control plan for phar macologically activ e substances, pesticides and contaminants – requir ed information
A. Scope of the control plan for phar macologically activ e subst ances, pesticides and cont aminants
(1) List of cate gories of food-producing animals, products of animal origin, including those used as ingredients in 
compo site products, covered by the control plan for phar macologically active substances, pesticides and 
contaminants, including details on the species and sub-species of animals.
(2) Information on the origin of the food-producing animals and products of animal origin covered by the control 
plan for phar macologically active substances, pesticides and contaminants, in particular whether they are 
produced, within the third countr y, entirely from animals or products of animal origin that originate from that 
countr y or whether they include animals or products of animal origin that originate from other third countr ies or 
Member States. If the food-producing animals and products of animal origin are not produced in the third countr y 
submitting the control plan for phar macologically active substances, pesticides and contaminants, information 
shall be provid ed on the countr ies of origin and the intended purpose of those animals and products of animal 
origin, in particular by explaining if the products of animal origin are intended for entr y into the Union as such or 
as ingredients of composit e products.EN Offi cial Jour nal of the European Union 24.11.2022 L 304/23  (3) National production data from the previous year for the animal species and products of animal origin covered by 
the control plan for phar macologically active substances, pesticides and contaminants.
(4) An explanation of whether , for the animals and products of animal origin concer ned, the control plan for 
phar macologically active substances, pesticides and contaminants covers the total national production or a 
propor tion of the national production (for example, the production of certain farms/producers and the 
throughput of certain establishments, intended for entr y into the Union). If only part of the national production is 
covered, a descr iption of the system in place to ensure that only those animals and products of animal origin from 
that segregat ed population covered by the control plan for phar macologically active substances, pesticides and 
contaminants are eligible for entr y into the Union.
B. Competent author ities responsible and their legal powers
(1) Contact details of the compet ent author ities: name and address of the central compet ent author ity or author ities 
and contact point details for correspondence on the control plan for phar macologically active substances, 
pesticides and contaminants (e.g., email addresses, teleph one numbers).
(2) A descr iption of the structure of the compet ent author ities, including, where relevant, the various levels of 
organisation (e.g. central, regional, local), the depar tments involved and organisational char ts.
(3) A descr iption of the role of the compet ent author ities involved in the implementation of the control plan for 
phar macologically active substances, pesticides and contaminants, including on aspects relat ed to the drawing up 
of the control plan for phar macologically active substances, pesticides and contaminants, the coordination and 
super vision of the imp lementation of the control plan for phar macologically active substances, pesticides and 
contaminants, the collection of samp les, the collation and evaluation of results, the application of corrective 
measures, if required, that are effective, propor tionat e and dissuasive to stop re-occur rence of non-com pliance, 
and the submission of an updated control plan for phar macologically active substances, pesticides and 
contaminants to the Commission.
(4) The legal basis of the control plan for phar macologically active substances, pesticides and contaminants, including 
references to the specifi c provisions giving the compet ent author ities the right to enter the relevant premises, to 
collect samples , to carry out follow-up inve stigations where non-com pliant results are detected and to impose 
corrective actions in such cases, for exam ple, restr ictions on the mov ement of animals, the destr uction of animals 
or the imposition of fines.
C. Phar macologically activ e subs tances
(1) The requirements met by the control plan for phar macologically active substances, pesticides and contaminants, in 
particular whether such requirements are those refer red to in Article 4 of Implementing Regulation (EU) 
2022/1646, or equivalent requirements. In the latter case, further details shall be provided on how these 
requirements address all of the points liste d under Part II, points C to K, of this Annex.
(2) The list of groups of substances covered by the control plan for phar macologically active substances, pesticides 
and contaminants for each animal species and product as specified in:
(a) point A.1 of Annex II to Delegat ed Regulation (EU) 2022/1646 for group A substances refer red to in Annex I 
to Delegat ed Regulation (EU) 2022/1644
(b) point B.1 of Annex II to Delegat ed Regulation (EU) 2022/1644 for group B substances refer red to in Annex I 
to Delega ted Regulation (EU) 2022/1644. For group B substances, the selection of groups covered by the 
control plan shall take into account the author isation and use of such substances and the risks of residues in 
animals and products of animal origin intende d for entr y into the Union.EN Offi cial Jour nal of the European Union L 304/24 24.11.2022  (3) Within the groups of substances covered by the control plan, the list of substances and their marker residues to be 
analysed for the specific animal species and products in the specific matr ices, including a justif ication for their 
selection based on the risk criteria set in Annex II to Deleg ated Regulation (EU) 2022/1644.
(4) The number of samples per animal species and products for each of the groups of substances covered by the 
control plan based on the control frequencies laid down in Annex I to Implementing Regulation (EU) 2022/1646, 
or equivalent guarantees. A descr iption of the criteria for selection of sampli ng points and animals or products of 
animal origin to be sam pled based on the criteria laid down in Annex II to Delegat ed Regulation (EU) 2022/1644
(5) A descr iption of the sampling strategy , explaining how it addresses the provisions of Annex III to Delegat ed 
Regulation (EU) 2022/1644.
D. Pesticides
(1) The list of substances tested for in the control plan for phar macologically active substances, pesticides and 
contaminants and the corresponding number of sam ples per catego ry of food-producing animals and products of 
animal origin covered by the control plan for phar macologically active substances, pesticides and contaminants in 
accordance with the requirements laid down in Implementing Regulation (EU) 2021/1355.
(2) A justification for the selection of substances covered by the control plan for phar macologically active substances, 
pesticides and contaminants, in particular that the range of substances tested for is representative of the pesticides 
used.
(3) The controls shall provid e guarant ees on the compl iance of food of animal origin intended for entr y into the Union 
with the maximum residue levels referred to in Regulation (EC) No 396/2005. These guarantees shall be provided 
for all pesticides author ised in the third countr y, in particular for those pesticides, which are author ised in the third 
countr y, but not author ised in the Union.
(4) A justification for the selection of pesticides covered by the plan, taking into account the risks from animal feed 
and the environment and the pesticides for whic h maximum residue levels are established in the Union, as well as 
a justification for the number of samples planned, based on the level of conf idence achi eved in identifying a certain 
percentage of excee dance of the maximum residue levels set out in Union legislation for the animals and products 
of animal origin intende d for entr y into the Union.
E. Contaminants
(1) The list of contaminants tested for in the control plan for phar macologically active substances, pesticides and 
contaminants and the corresponding number of sam ples per catego ry of food-producing animals and products of 
animal origin covered by the control plan for phar macologically active substances, pesticides and contaminants, in 
accordance with the requirements laid down in Delegat ed Regulation (EU) 2022/931 and Implementing 
Regulation (EU) 2022/932.
(2) A justif ication for the selection of contaminants covered by the control plan for phar macologically active 
substances, pesticides and contaminants taking into account the risks from animal feed and the environment, as 
well the contaminants for which maximum limits have been set in the Union in products of animal origin covered 
by the control plan for phar macologically active substances, pesticides and contaminants.
F.Analytical methods and laborator ies
(1) The list of official laboratori es or contracted laboratories, or both, involved in carrying out analyses for the control 
plan for phar macologically active substances, pesticides and contaminants.EN Offi cial Jour nal of the European Union 24.11.2022 L 304/25  (2) The accreditation status, including the scope of accreditation, of each of the official laboratori es carrying out 
analyses for the control plan for phar macologically active substances, pesticides and contaminants.
(3) For each of the laborat ories, a list of all the methods used in the control plan for phar macologically active 
substances, pesticides and contaminants, with an indication on whether they are included or not in the scope of 
accreditation for the specific matr ices covered by the control plan for phar macologically active substances, 
pesticides and contaminants.
(4) For each of the laboratori es, a list of the methods used in the control plan for phar macologically active substances, 
pesticides and contaminants, with an indication of whether they are validat ed in accordance with the relevant 
Union rules, or equivalent rules, or not validated, for the specific matr ices covered by the control plan for 
phar macologically active substances, pesticides and contaminants, specifying the standard used for validation.
(5) For each of the substances tested for in the control plan for phar macologically active substances, pesticides and 
contaminants, a list of the analytical methods and regulatory standards used for interpreting analytical results and 
the perf ormance requirements of the analytical methods, including information on:
(a) the analysed substance and mark er residues;
(b) the analysed matr ices;
(c) the analytical method identification (e.g. ELIS A, LC-MS/MS, AAS);
(d) the analytical method type (screening or conf irmatory );
(e) the screening and conf irmat ory methods used, the limits of detection and limits of quantif ication or, if 
relevant, the decision limit for confir mation (CCα) and detection capability for screening (CCß) as defined in 
Article 2, second paragraph, points (14) and (15), of Implementing Regulation (EU) 2021/808;
(f) the concentration above whic h a result is considered non-com pliant for the purpose of the control plan for 
phar macologically active substances, pesticides and contaminants. In particular , diffe rences with the limits set 
out in the Union legislation shall be indicated .
G. Phar macologically activ e subst ances author ised in veter inar y medicinal products or as feed additiv es for use 
in food-producing animals and prohibitions on use in such animals
(1) The national legislation governing the placing on the mark et and conditions for use of veterinar y medicinal 
products in relation to food-producing animal species covered by the control plan for phar macologically active 
substances, pesticides and contaminants, including references to the relevant provisions.
(2) The list of author ised veterinar y medicinal products for the food-producing animal species covered by the control 
plan for phar macologically active substances, pesticides and contaminants indicating for each product, the product 
name, the phar macologically active substance(s) contained therein and target species. Those substances which are 
author ised in the third countr y but whic h are not author ised for such use in the Union shall be highlighted in the 
list. The list shall also include feed additives that are phar macologically active, such as antibiotics, coccidiostats 
and histomonostats.
(3) A descr iption of the system in place to ensure that, for each of the substances which are author ised in the third 
countr y for use in the animal species covered by the control plan for phar macologically active substances, 
pesticides and contaminants, but not author ised for such use in the Union, there are no residues present at 
concentrations whic h can be reliably quantified in such animals or products of animal origin intended for entr y 
into the Union. Evidence shall be provid ed that such substances are tested for in the appropr iate matr ices in the 
control plan for phar macologically active substances, pesticides and contaminants for the relevant animals and 
products of animal origin.EN Offi cial Jour nal of the European Union L 304/26 24.11.2022  (4) A statement on whether any of the substances included in Table 2 of the Annex to Regulation (EU) No 37/2010 are 
author ised for use in the food-producing animal species covered by the control plan for phar macologically active 
substances, pesticides and contaminants. If such substances are author ised, a descr iption of the system ensur ing 
that animals treated with such substances and products derived therefrom are not eligible for entr y into the Union 
shall be provided. If use of such substances in food-producing animals is prohibited in the third countr y, a 
reference to the national legal basis for that prohibition shall be provi ded.
(5) A conf irmation that stilbene substances (i.e. stilbenes, stilbene derivatives, their salts and esters) or thyrost atic 
substances are not author ised for use in food-producing animal species covered by the control plan for 
phar macologically active substances, pesticides and contaminants, regardless of their eligibility for entr y into the 
Union, and a referen ce to the national legal basis for that prohibition.
(6) A statement on whether substances having an oestroge nic, androgenic or gestagenic action and beta-agonists are 
author ised for growth promotion purposes in the food-producing animal species covered by the control plan for 
phar macologically active substances, pesticides and contaminants. If such substances are author ised, a detailed 
descr iption of the system in place to ensure that treated animals are not eligible for entr y into the Union shall be 
provi ded. If such substances are either not author ised or are expressly prohibited, a reference to the national legal 
basis for the prohibition shall be provid ed.
H. Specif ic informa tion for bovine, capr ine and ovine animals and products of animal origin derived therefrom, 
including milk
(1) A statement on whether 17-beta oestradiol and its ester-like derivatives are author ised and used in veterinar y 
medicinal products for any purpose in the species in question, including zoote chnical or therapeutic treatments. If 
such substances are author ised, a descr iption of the system ensur ing that animals treated with such substances and 
the products derived therefrom are not eligible for entr y into the Union shall be provid ed. If such substances are 
prohibit ed, a reference to the national legal basis for the prohibition shall be provided.
(2) Bovine, capr ine and ovine animals and products of animal origin derived therefrom, including milk eligible for 
entr y into the Union from a third countr y included in the list of third countr ies with an approved control plan for 
phar macologically active substances, pesticides and contaminants, referred to in Annex -I to Imple menting 
Regulation (EU) 2021/405, shall originat e in that third countr y, or in Member States, or in other third countr ies 
implementing a control plan for phar macologically active substances, pesticides and contaminants approved by 
the Commission.
I. Specif ic informa tion for honey
(1) If antimicrobial substances are author ised for the treatment or prevention of diseases in hone ybees, a descr iption 
of the system in place to provi de guarant ees that no residues are present, at concentrations which can be 
quantified, in hone y intende d for entr y into the Union.
(2) Honey intended for entr y into the Union from a third countr y included in a list of third countr ies with approved 
control plan for phar macologically active substances, pesticides and contaminants as referred to in Annex -I to 
Implementing Regulation (EU) 2021/405 shall originat e in that third countr y, or in Member States, or in other 
third countr ies implementing a control plan for phar macologically active substances, pesticides and contaminants 
appro ved by the Commission.EN Offi cial Jour nal of the European Union 24.11.2022 L 304/27  J. Specif ic informa tion for aquaculture
(1) If dyes are author ised for the treatment and prevention of disease at any stage of production, a descr iption of the 
dyes used and the fisher y products (including crustaceans) for which the treatment is author ised and of the 
system in place to provide guarant ees that no residues are present at concentrations whic h can be quantified in 
aquaculture products intended for entr y into the Union.
(2) Aquaculture products intended for entr y into the Union from a third countr y included in a list of third countr ies 
with appro ved control plan for phar macologically active substances, pesticides and contaminants as refer red to in 
Annex -I to Implementing Regulation (EU) 2021/405 shall originat e in that third countr y, or in Member States, or 
in other third countr ies implementing a control plan for phar macologically active substances, pesticides and 
contaminants approved by the Commission.
K. Specif ic informa tion for equine animals
(1) A descr iption of the system in place to ensure that equine animals treated with substances prohibit ed or not 
author ised in the Union for use in food-producing animals and products for human consum ption derived from 
such animals are not eligible for entr y into the Union. The following elements of such a system shall be descr ibed:
(a) identif ication and traceability of equine animals;
(b) record keeping of administration of veterinar y medicinal products;
(c) records indicating all treatments with phar macologically active substances.
(2) Where equine animals are treated with substances considered essential under Union rules, a descr iption of the 
system in place to ensure that food derived from such animals is not eligible for entr y into the Union until six 
months have elapsed since the last treatment.
(3) Food-producing equine animals eligible for entr y into the Union shall originate from the third countr y whic h 
intends to enter into the Union equine animals, or in other third countr ies implementing a control plan for 
phar macologically active substances, pesticides and contaminants approved by the Commission.
L. Specif ic informa tion to be provided by the third countr ies refer red to in Article 8(1) and (2)
(1) A statement by the compet ent author ity of the third countr y conf irming that products of animal origin intended 
for entr y into the Union as such, or as ingredients of compo site products, only originate in third countr ies 
included in the list of third countr ies with an approved control plan for phar macologically active substances, 
pesticides and contaminants for those food-producing animals or products of animal origin, and that the 
procedures it has in place for this purpose are sufficient to guarant ee the traceability and origin of those products 
of animal origin.
(2) A compre hensive descr iption, by the compet ent author ity of the third countr y, of the procedures in place in the 
third countr y, to substantiate the statement refer red to in point 1.
M. Specif ic informa tion for casings
A descr iption of the system in place to ensure that no antimicrobial substances, the use of which in food-producing 
animals is prohibited in the Union in accordance with Table 2 of the Annex to Regulation (EU) No 37/2010, are used 
in the treatment of casings.EN Offi cial Jour nal of the European Union L 304/28 24.11.2022  PART III
Updated control plan for phar macologically activ e substances, pesticides and contaminants – requir ed information
A. Changes introduced in the updated control plan for phar macologically activ e subst ances, pesti cides and 
contaminants
(1) Updat ed production data of the animals and products of animal origin covered by the control plan for 
phar macologically active substances, pesticides and contaminants and the imp act on the number of planned 
sam ples.
(2) Details on any chang es that have occur red since the previous annual submission of the control plan for 
phar macologically active substances, pesticides and contaminants and that alter the information previously 
provi ded under Part II, points A to M.
(3) In the absence of chang es, a statement that no changes have occur red shall be included under Part II, points A to M, 
where relevant.
B. Results of the implement ation of the previous year’s control plan for phar macologically activ e subst ances, 
pesticides and cont aminants
(1) The results of the imp lementation of the previous year ’s control plan for phar macologically active substances, 
pesticides and contaminants, together with the updated control plan for phar macologically active substances, 
pesticides and contaminants.
(2) A justification for any discrepancies between the number of sam ples, or the substances planned to be analysed, and 
the number of sam ples and/or the substances actually analysed.
(3) Details on results non-compliant with Union maximum residue limits of phar macologically active substances, 
maximum residue levels of pesticides or maximum levels of contaminants, including, for each of these non- 
compl iant results, the dates of sampling, dates of availability of the analytical results, mark er residues identified, 
concentrations measured, analytical methods used and the laboratori es involved.
(4) For each of the non-comp liant results, a descr iption of the outcome of the follow-up inve stigations under taken by 
the compet ent author ities, what the reason for the non-com pliance was and any measures take n to prevent 
recur rence.EN Offi cial Jour nal of the European Union 24.11.2022 L 304/29  ANNEX II 
Cor relation table refer red to in Article 24, second parag raph
Delegat ed Regulation (EU) 2019/625 This Regulation
Article 1 Article 1
Article 2 Article 2
Article 3 Article 3
Article 4 Article 4
Article 5 Article 13
Article 6 Article 14
Article 7 Article 15
Article 8 Article 16
Article 9 Article 17
Article 10 Article 18
Article 11 Article 19
Article 12 Article 20
Article 13 Article 21
Article 14 Article 22EN Offi cial Jour nal of the European Union L 304/30 24.11.2022