EN   EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX  
SANTE/11988/2017 CIS 
(POOL/G4/2017/11998/11998-EN 
CIS.docx) 
[…](2022) XXX draft 
 
COMMISSION DELEGATED REGULATION (EU) …/... 
of XXX 
supplementing Regulation (EU) 2017/625 of the European Parliament and of the 
Council with regard to requirements for the entry into the Union of consignments of 
food-producing animals and certain goods intended for human consumption 
 (Text with EEA relevance)  
EN 1  EN  
EN 2  EN COMMISSION DELEGATED REGULATION (EU) …/... 
of XXX 
supplementing Regulation (EU) 2017/625 of the European Parliament and of the 
Council with regard to requirements for the entry into the Union of consignments of 
food-producing animals and certain goods intended for human consumption 
 (Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, 
Having regard to Regulation (EU) 2017/625 of the European Parliament and the Council of 
15 March 2017 on official controls and other official activities performed to ensure the 
application of food and feed law, rules on animal health and welfare, 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 (Official Controls Regulation)1, and in particular 
Article 126(1) thereof,  
Whereas: 
(1) Regulation (EU) 2017/625 lays down rules for the performance of official 
controls and other official activities by the competent authorities of the Member 
States, in particular to ensure compliance, by consignments of animals and 
goods from third countries or regions thereof intended for human consumption, 
upon entry into the Union, with Union legislation on food and feed safety. 
(2) Regulation (EU) 2017/625 empowers the Commission to adopt delegated acts to 
supplement the conditions laid down in that Regulation for the entry into Union 
of food-producing animals and certain goods. Those conditions may include 
additional requirements, namely the possibility of allowing the entry of animals 
and goods only from third countries 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 consumption, in accordance with Council Directive 
96/23/EC2 and the provisions provided for in Council Directive 96/22/EC3; 
 
1 OJ L 95, 7.4.2017, p. 1.  
2 Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues 
thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and 
Decisions 89/187/EEC and 91/664/EEC (OJ L 125, 23.5.1996, p. 10).  
EN 3  EN – the rules for the prevention, control and eradication of transmissible 
spongiform encephalopathies in live animals and products of animal origin, in 
accordance with Regulation (EC) No 999/2001 of the European Parliament and 
of the Council4; 
– the general principles and requirements governing 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 Council5; 
– the general rules for food business operators on the hygiene of foodstuffs, in 
accordance with Regulation (EC) No 852/2004 of the European Parliament and 
of the Council6; 
– the specific rules on the hygiene of food of animal origin for food business 
operators, in accordance with Regulation (EC) No 853/2004 of the European 
Parliament and of the Council7; 
– the specific rules on official controls performed, and for actions taken, by the 
competent authorities on the production of certain animals and products of 
animal origin intended for human consumption, in accordance with 
Commission Delegated Regulation (EU) 2019/6248 and Commission 
Implementing Regulation (EU) 2019/6279. 
(3) Commission Delegated Regulation (EU) 2019/62510 laid 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 countries from which animals and products of animal origin are 
authorised for the entry 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 existence of a control plan setting out guarantees on the monitoring 
 
3  Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of 
certain substances having a hormonal or thyrostatic action and of ß-agonists, and repealing Directives 
81/602/EEC, 88/146/EEC and 88/299/EEC (OJ L125, 23.5.1996, p. 3) 
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 spongiform 
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 January 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 April 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 April 2004 laying 
down specific hygiene rules for food of animal origin (OJ L 139, 30.4.2004, p. 55). 
8 Commission Delegated Regulation (EU) 2019/624 of 8 February 2019 concerning specific rules for the 
performance 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 uniform practical 
arrangements for the performance of official controls on products of animal origin intended for human 
consumption in accordance with Regulation (EU) 2017/625 of the European Parliament and of the 
Council and amending Commission Regulation (EC) No 2074/2005 as regards official controls (OJ L 
131, 17.5.2019, p. 51). 
10 Commission Delegated Regulation (EU) 2019/625 of 4 March 2019 supplementing Regulation (EU) 
2017/625 of the European Parliament and of the Council with regard to requirements for the entry into 
the Union of consignments of certain animals and goods intended for human consumption (OJ L 131, 
17.5.2019, p. 18).  
EN 4  EN of certain groups of residues and substances, 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 provided for the transitional application, until 14 
December 2022, of certain provisions of that Directive. 
(6) The introduction of additional requirements to ensure compliance with the 
measures for monitoring substances and groups of residues in animals and goods 
intended for human consumption laid down in Directive 96/23/EC should be 
combined with the additional requirements already laid down in Delegated 
Regulation (EU) 2019/625. 
(7) It is thus appropriate to lay down all these additional requirements in one single 
Delegated Regulation, thereby simplifying their interpretation and application 
and enhancing transparency for third countries. 
(8) Regulation (EC) No 853/2004 lays down requirements for food business 
operators importing products of animal origin into the Union. Accordingly, 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 entry into the Union of consignments of 
certain animals and good intended for human consumption, reference should be 
made to the Combined Nomenclature codes set out in Council Regulation (EEC) 
No 2658/8711, to identify these goods and animals clearly. 
(10) Consignments of certain animals and goods intended for human consumption 
should only be allowed to enter the Union, based on a risk analysis, where the 
third countries or regions thereof from which these animals and goods originate 
can ensure compliance with the requirements on the safety of those animals and 
goods and those third countries 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) 2021/40512. 
(11) In addition to the requirements laid down in Article 127(3) of Regulation (EU) 
2017/625, specific requirements should be laid down for certain animals and 
goods intended for human consumption, to ensure that third countries or regions 
thereof provide guarantees on the efficiency of official controls on food safety as 
regards those animals and goods. Third countries 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 comply 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, Delegated Regulation (EU) 2019/624 and 
Implementing Regulation (EU) 2019/627, or with requirements recognised to be 
equivalent thereto. 
 
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 
countries or regions thereof authorised for the entry into the Union of certain animals and goods 
intended for human consumption in accordance with Regulation (EU) 2017/625 of the European 
Parliament and of the Council (OJ L 114, 31.3.2021, p. 118).  
EN 5  EN (12) Under Article 127(3) of Regulation (EU) 2017/625, the Commission may 
subject the decision to include third countries in lists laid down in Implementing 
Regulation (EU) 2021/405 to the provision, by those third countries, of 
appropriate evidence and guarantees of compliance with the Union requirements 
on the use of pharmacologically active substances in food-producing animals 
and of the compliance of consignments of products of animal origin and 
composite products intended to enter into the Union with the maximum residue 
limits of pharmacologically 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 
composite products offer a same level of health protection to that provided for 
by the Union legislation on food and food safety. 
(13) To ensure that same level of health protection, evidence and guarantees have to 
be provided by submitting a control plan that meets certain requirements, 
provided for in this Regulation and to ensure continuous compliance with those 
requirements, updated control plans should be submitted to the Commission on a 
yearly basis.  
(14) However, third countries may also be included in the list laid down in Annex -I 
to Implementing Regulation (EU) 2021/405 if they provide appropriate evidence 
and guarantees that the food-producing animals and products of animal origin, 
including those used in composite products entering the Union, originate in a 
Member State or a third country included in a list of third countries with 
approved control plans for those food-producing animals, products of animal 
origin and composite products. Information on the procedures in place to ensure 
the traceability and to guarantee the origin of the concerned food-producing 
animals or products of animal origin should be provided to benefit from that 
derogation.  
(15) Union legislation lays down rules on the use of pharmacologically active 
substances and establishes limits for their residues in edible products of animal 
origin arising from such use. Food-producing animals, products of animal origin 
and composite products should only enter the Union from third countries 
ensuring that controls on the use of pharmacologically active substances and the 
residues thereof in animal products are at least equivalent to those of the Union 
control plans included in the multi-annual national control plans referred to in 
Commission Delegated Regulation 2022/x13 (C(2022)4400) and Commission 
Implementing Regulation 2022/xx14 (C(2022)4401). The rules laid down in 
Commission Implementing Regulation (EU) 2021/80815 should apply to the 
official controls on those substances and residues. 
 
13 Commission Delegated Regulation (EU) 2022/x of … (C(2022)4400) supplementing Regulation (EU) 
2017/625 of the European Parliament and of the Council with specific requirements for the performance 
of official controls on the use of pharmacologically active substances authorised as veterinary medicinal 
products or as feed additives and on the use of prohibited or unauthorised pharmacologically active 
substances and residues thereof (OJ L …, … , p. …). 
14 Commission Implementing Regulation (EU) 2022/xx of … (C(2022)4401) on uniform practical 
arrangements of multi-annual national control plans (MANCPs) and annual reports by Member States 
on the performance of official controls on the use of pharmacologically active substances authorised as 
veterinary medicinal products or as feed additives and of prohibited or unauthorised pharmacologically 
active substances and residues thereof (OJ L …, … , p. …). 
15 Commission Implementing Regulation (EU) 2021/808 of 22 March 2021 on the performance of 
analytical methods for residues of pharmacologically active substances used in food-producing animals  
EN 6  EN (16) The use, in food-producing animals in the Union, of beta-agonists and 
substances that have a hormonal or thyrostatic action is prohibited under Council 
Directive 96/22/EC16. Similarly, Commission Regulation (EU) No 37/201017 list 
in Table 2 of the Annex to that Regulation pharmacologically active substances, 
that are prohibited for use in the Union.  . Guarantees that food-producing 
animals, products of animal origin and composite products intended for entry 
into the Union comply with these provisions has to be provided.  
(17) Regulation (EC) No 396/2005 of the European Parliament and of the Council18 
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 States are to 
establish. Food-producing animals, products of animal origin and composite 
products should only enter the Union from third countries, 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) 2021/135519. It should thus be ensured that evidence is 
provided through statistically representative sampling that the products intended 
for entry into the Union comply with Union legislation on pesticide residues. 
(18) Commission Delegated Regulation (EU) 2022/93120 and Commission 
Implementing Regulation (EU) 2022/93221 provide for the establishment and the 
content of risk-based control plans on contaminants in food. Food of animal 
origin and composite products should only enter the Union from third countries, 
which ensure that controls on contaminants are carried out to provide evidence 
that food of animal origin and composite products intended for the entry into the 
Union comply with EU legislation on contaminants. 
 
and on the interpretation 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 Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of 
certain substances having a hormonal or thyrostatic action and of beta-agonists, and repealing 
Directives 81/602/EEC, 88/146/EEC and 88/299/EEC (OJ L 125, 23.5.1996, p. 3). 
17 Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active 
substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ 
L 15, 20.1.2010, p. 1). 
18 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 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).  
19 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). 
20 Commission Delegated 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 performance of 
official controls as regards contaminants in food (OJ L162, 17.6.2022, p. 7). 
21 Commission Implementing Regulation (EU) 2022/932 of 9 June 2022 on uniform practical 
arrangements for the performance 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 L162, 17.6.2022, p. 13).  
EN 7  EN (19) Commission Decision 2011/163/EU22 sets out, in accordance with Directive 
96/23/EC, a list of third countries authorised for the entry 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/xxxxx23 replaced Decision 2011/163/EU in its entirety. 
(21) Consignments of certain goods intended for human consumption should only be 
allowed to enter the Union where those goods are dispatched 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 compliance with Union food hygiene 
rules, or with rules recognised to be at least equivalent thereto, it is appropriate 
to provide that, when drawing up and updating that list, the third country should 
provide additional guarantees to those provided for in Article 127(3), points 
(e)(i) and (iv), of Regulation (EU) 2017/625. 
(22) The lists of establishments referred 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 operators and consumers. To strengthen such 
transparency, Member States should only allow the entry of consignments of 
animals and goods where the official certificates required for such consignments 
under the relevant Union rules are issued by the competent authorities of the 
third country after the publication of those lists. 
(23) It is not necessary to lay down such listing requirements as regards goods 
intended for transit, since those goods represent a low risk from a food safety 
perspective and are not placed on the market within the Union. Moreover, such 
requirements should not apply to establishments carrying out only primary 
production activities, transport operations, storage of products of animal origin 
not requiring temperature-controlled storage conditions or production of highly 
refined products referred to in Section XVI of Annex III to Regulation (EC) No 
853/2004. 
(24) Commission Regulation (EU) No 210/201324 requires establishments producing 
sprouts to be approved by the competent authorities in accordance with Article 6 
of Regulation (EC) No 852/2004. In order to ensure compliance with Union food 
hygiene rules, or with rules recognised to be at least equivalent thereto, sprouts 
should only be allowed entry into the Union if they are produced in 
establishments, which appear on lists drawn up and updated in accordance with 
this Regulation. 
(25) In order to ensure compliance with Union food hygiene rules, or with rules 
recognised to be at least equivalent thereto, products from establishments 
manufacturing fresh meat, minced meat, meat preparations, meat products, 
 
22 Commission Decision 2011/163/EU of 16 March 2011 on the approval of plans submitted by third 
countries in accordance with Article 29 of Council Directive 96/23/EC (OJ L 70, 17.3.2011, p. 40). 
23 Commission Implementing Regulation (EU) 2022/xxxxx of … [ISC/2022/02577] amending 
Implementing Regulation (EU) 2021/405 as regards the list of third countries with an approved control 
plan on the use of pharmacologically active substances, the maximum residue limits of 
pharmacologically active substances and pesticides and the maximum levels of contaminants, and 
repealing Commission Decision 2011/163/EU (OJ L …, … , p. …). 
24 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 8  EN mechanically separated meat and raw materials intended for the production of 
gelatine and collagen should only be allowed entry into the Union if those 
establishments appear on lists drawn up and updated in accordance with Article 
127(3), point (e)(ii), of Regulation (EU) 2017/625. In addition, the raw materials 
these products are manufactured from should come from establishments 
(slaughterhouses, game-handling establishments, cutting plants and 
establishments handling fishery products) appearing 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, echinoderms, tunicates and marine 
gastropods should only be allowed entry into the Union from production areas in 
third countries or regions thereof that appear on lists drawn up and updated in 
accordance with Article 127(3), point (e)(ii), of Regulation (EU) 2017/625 in 
order to ensure compliance with the applicable specific 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 operators and consumers as regards the production areas from which 
live bivalve molluscs, echinoderms, tunicates and marine gastropods are allowed 
to enter the Union. 
(27) Consignments of fishery products should only be allowed to enter the Union 
where those consignments are dispatched from, obtained or prepared in an on-
land establishment, reefer, factory or freezer vessels flying the flag of a third 
country that appears on lists drawn up and updated 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 specific requirements for fishery 
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 operators and consumers as regards the vessels whose fishery products 
may enter the Union. 
(28) The risk associated with composite products depends on the type of ingredients 
thereof and on the conditions of storage of those ingredients. Requirements on 
the consignments of composite products should therefore be laid down, to ensure 
that the composite products presenting a risk are exported from countries 
authorised for entry into the Union pursuant to Implementing Regulation (EU) 
2021/405. Composite products presenting a risk are those that contain processed 
products of animal origin, for which specific requirements are laid down in 
Annex III to Regulation (EC) No 853/2004, or for which a residue-monitoring 
plan is required. 
(29) Given the number of notifications received in the Rapid Alert 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 
consumption present an enhanced risk of non-compliance with Union 
requirements on food safety. The consignments of such animals and goods 
should therefore be subject to individual certification for each consignment prior 
to the entry into the Union. That certification also contributes to reminding food 
business operators and the competent authorities of third countries or regions 
thereof of the relevant Union requirements. Commission Implementing  
EN 9  EN Regulation (EU) 2020/223525 lays down model animal health and/or official 
certificates for that purpose. Consignments for such animals and goods for 
which the Union is not the final destination should be accompanied by animal 
health certificates or official certificates with animal health attestation, whilst 
public health attestation for those animals and goods is not needed, since they 
will not be placed on the market in the Union. As regards certain composite 
products, which present a low risk, private attestation by the importing food 
business operator should replace the certification to ensure a proportionate, risk-
based approach. 
(30) Shelf-stable composite products representing a negligible risk, such as those 
where the only animal product present in the final composite product are food 
improvement agents, namely vitamin D3, food additives, food enzymes or food 
flavourings, should be exempted from the controls at the borders and from the 
private attestation requirements. 
(31) Delegated Regulation (EU) 2019/625 should therefore be repealed and replaced 
by this Regulation,  
(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 REGULATION: 
CHAPTER I: Scope and definitions 
Article 1 
Subject matter and scope  
1. This Regulation supplements Regulation (EU) 2017/625 as regards the requirements 
for the entry in the Union of consignments of food-producing animals and certain 
goods intended for human consumption from third countries or regions thereof in 
order to ensure that they comply 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 referred to in paragraph 1 cover: 
(a) the identification of food-producing animals and certain goods intended for 
human consumption subject to the following requirements for entry into the 
Union: 
(i) the requirement that those food-producing animals and certain goods 
intended for human consumption shall come from a third country or 
region thereof listed in accordance with Article 126(2), point (a), of 
Regulation (EU) 2017/625; 
 
25 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/official certificates, for the entry into the Union and movements within the Union of 
consignments of certain categories of animals and goods, official certification regarding 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 10  EN (ii) the requirement that those food-producing animals and certain goods 
intended for human consumption be dispatched from, and obtained or 
prepared in, establishments which comply with applicable requirements 
referred to in Article 126(1) of Regulation (EU) 2017/625, or with 
requirements recognised to be at least equivalent thereto, and which 
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 consumption be accompanied, by an 
official certificate, or official attestation or any other evidence of 
compliance with the rules referred to in Article 1(2), point (a), of 
Regulation (EU) 2017/625, such a as private attestation, in accordance 
with Article 126(2), point (c), of Regulation (EU) 2017/625; 
(b) requirements for the entry into the Union of food-producing animals and 
certain goods intended for human consumption from a third country 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 consumption from third countries be dispatched from, and 
obtained or prepared in, establishments which comply with the applicable 
requirements referred to in Article 126(1) of Regulation (EU) 2017/625, or 
with requirements recognised to be at least equivalent thereto, and which 
appear on lists drawn up and updated in accordance with Article 127(3), 
points (e)(ii)and (iii) of Regulation (EU) 2017/625; 
(d) requirements for the entry into the Union for placing on the market of the 
specific 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, 
mechanically separated meat and raw materials intended for the 
production of gelatine and collagen; 
(ii) live bivalve molluscs, echinoderms, tunicates and marine gastropods; 
(iii) fishery products; 
(iv) composite products;  
(e) additional requirements for the official certificates, official attestations and 
private attestations that shall accompany food-producing animals and certain 
goods intended for human consumption for entry into the Union; 
(f) requirements for the use of pharmacologically 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 composite products, 
where those food-producing animals, products of animal origin and composite 
products enter the Union from third countries and are intended to be placed on 
the market of the Union, and those requirements are necessary to ensure that 
such food-producing animals, products of animal origin and composite 
products provide a level of human health protection equivalent to that provided 
by the relevant Union rules on food safety; 
(g) the requirement that food-producing animals, products of animal origin and 
composite products shall only enter the Union from third countries that provide  
EN 11  EN evidence and guarantees 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 consumption, however when the 
destination of the animals and goods has not been decided at entry into the 
Union, this Regulation applies; 
(b) Animals and goods intended for human consumption only for transit through 
the Union without being placed on the market. 
(c) Goods intended for human consumption for the purpose of samples for product 
analysis and quality testing without being placed on the market. 
Article 2 
Definitions 
For the purposes of this Regulation, the following definitions shall apply: 
(1) ‘entering the Union’ or ‘entry into the Union’ means entering the Union or entry 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) to 
Regulation (EU) 2017/625; 
(8) ‘official attestation’ means official attestation as defined in Article 3, point (28) to 
Regulation (EU) 2017/625; 
(9) ‘private attestation’ means an attestation signed by the importing food business 
operator; 
(10) ‘placing on the market’ 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;  
EN 12  EN (15) ‘mechanically separated meat’ means mechanically separated 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) ‘collagen’ means collagen as defined in point 7.8 of Annex I to Regulation (EC) No 
853/2004; 
(18) ‘bivalve molluscs’ means bivalve molluscs as defined in point 2.1 of Annex I to 
Regulation (EC) No 853/2004; 
(19) ‘fishery products’ means fishery products as defined in point 3.1 of Annex I to 
Regulation (EC) No 853/2004; 
(20) ‘composite product’ means food containing both products of plant origin and 
processed products of animal origin; 
(21) ‘pharmacologically active substance’ means pharmacologically active substance as 
defined in Article 2, point (a), of Delegated Regulation (EU) 2019/209026; 
(22) ‘contaminant’ means contaminant as defined in Article 1(1), second subparagraph, of 
Council Regulation (EEC) No 315/9327; 
(23) ‘pesticide residues’ means pesticide residues as defined in Article 3(2), point (c), of 
Regulation 396/2005; 
(24) ‘product of animal origin’ means product of animal origin as defined in point 8.1 of 
Annex I to Regulation (EC) No 853/2004; 
(25) ‘control plan’ means control plan as defined in Article 3, point (8) of Regulation 
(EU) 2017/625 for the areas on the use of pharmacologically active substances and 
their residues, contaminants and pesticide residues in food-producing animals, 
products of animal origin and composite products; 
(26) ‘insects’ means food consisting of, isolated from or produced from insects or their 
parts including any life stadia of insects intended for human consumption which are, 
when applicable, authorised in accordance with Regulation (EU) 2015/228328 and 
included in the Union list of novel foods established by Commission Implementing 
Regulation (EU) 2017/247029 (‘the Union list of novel foods’); 
(27) ‘transit’ means transit as defined in Article 3, point (44), of Regulation (EU) 
2017/625; 
 
26  Commission Delegated Regulation (EU) 2019/2090 of 19 June 2019 supplementing Regulation (EU) 
2017/625 of the European Parliament and Council regarding cases of suspected or established non-
compliance with Union rules applicable to the use or residues of pharmacologically active substances 
authorised in veterinary medicinal products or as feed additives or with Union rules applicable to the 
use or residues of prohibited or unauthorised pharmacologically active substances (OJ L 317, 
9.12.2019, p. 28). 
27 Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for 
contaminants in food (OJ L 307, 13.2.1993, p. 1). 
28  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). 
29  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).  
EN 13  EN (28) ‘reptile meat’ means the edible parts, either unprocessed or processed, derived from 
farmed reptiles, belonging to the species Alligator mississippiensis, Crocodylus 
johnstoni, Crocodylus niloticus, Crocodylus porosus, Timon Lepidus, Python 
reticulatus, Python molurus bivittatus  or Pelodiscus sinensis , which are, when 
applicable, authorised in accordance with Regulation (EU) 2015/2283 of the 
European Parliament of the Council and included in the Union list of novel foods; 
(29) ‘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, Hygromiidae  or 
Sphincterochilidae , intended for human consumption; 
(30) ‘food’ means food as defined in Article 2 of Regulation (EC) No 178/2002; 
(31) ‘feed’ or ‘feedingstuff’ means feed or feedingstuff as defined in Article 3, point (4) 
to Regulation (EC) No 178/2002; 
(32) ‘audit’ means audit as defined in Article 3, point (30), of Regulation (EU) 2017/625; 
(33) ‘competent authorities’ means competent authorities as defined in Article 3, point 
(3), of Regulation (EU) 2017/625; 
(34)  ‘sprouts’ means sprouts as defined in Article 2, point (a), of Commission 
Implementing Regulation (EU) No 208/201330; 
(35) ‘primary production’ means primary production as defined in Article 3, point (17), of 
Regulation (EC) No 178/2002; 
(36) ‘slaughterhouse’ means slaughterhouse as defined in point 1.16 of Annex I to 
Regulation (EC) No 853/2004; 
(37) ‘game-handling establishment’ means game-handling establishment as defined in 
point 1.18 of Annex I to Regulation (EC) No 853/2004; 
(38) ‘cutting plant’ means cutting plant as defined in point 1.17 of Annex I to Regulation 
(EC) No 853/2004; 
(39) ‘production area’ means production area as defined in point 2.5 of Annex I to 
Regulation (EC) No 853/2004; 
(40) ‘factory vessel’ means factory vessel as defined in point 3.2 of Annex I to Regulation 
(EC) No 853/2004; 
(41) ‘freezer vessel’ means freezer vessel as defined in point 3.3 of Annex I to Regulation 
(EC) No 853/2004; 
(42) ‘reefer vessel’ means a vessel equipped to store and transport palletised or loose 
cargo (bulk) goods in temperature-controlled holds or chambers; 
(43) ‘dairy products’ means dairy products as defined in point 7.2 of Annex I to 
Regulation (EC) No 853/2004; 
(44) ‘egg products’ means egg products as defined in point 7.3 of Annex I to Regulation 
(EC) No 853/2004; 
(45) ‘food business operator’ means a food business operator as defined in Article 3, point 
(3), of Regulation (EC) No 178/2002. 
 
30 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 14  EN (46) ‘operator’ means operator as defined in Article 3, point (29), of Regulation (EU) 
2017/625; 
(47) ‘border control post’ means border control post as defined in Article 3, point (38) to 
Regulation (EU) 2017/625; 
 
CHAPTER II: Conditions for the entry into the Union as regards 
third countries of origin or regions thereof 
Article 3 
Food-producing animals and goods which are required to come from third countries or 
regions thereof included in the list referred to in Article 126(2), point (a), of Regulation 
(EU) 2017/625 
Consignments of the following food-producing animals and goods intended for human 
consumption shall enter the Union only from a third country or region thereof included in the 
list for those animals and goods laid down in Implementing Regulation (EU) 2021/405: 
(a) products of animal origin, including reptile meat and dead whole insects, parts of 
insects or processed insects, intended for human consumption, 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 Chapters 2 to 5, 15, 16 or 29; or 
(ii) HS headings 0901, 1702, 2105, 2106, 2301, 3001, 3002, 3302, 3501, 3502, 
3503, 3504, 3507, 3913, 3926, 4101, 4102, 4103 or 9602; 
(b) live insects, other than bees, referred to by the CN code 0106 49 00 of Part Two of 
Annex I to Regulation (EEC) No 2658/87; 
(c) live snails, other than sea snails, referred to by the CN code 0307 60 00 of Part Two 
of Annex I to Regulation (EEC) No 2658/87; 
(d) pollen flour falling under the CN code ex 1212 99 95 of Part Two of Annex I to 
Regulation (EEC) No 2658/87. 
Article 4 
Additional requirements for the entry into the Union of food-producing animals and 
goods from a third country 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 countries or regions thereof in the list 
referred to in Article 126(2), point (a), of that Regulation if the following 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 referred to in Article 3 of this Regulation: 
(a) the legislation of the third country on: 
(i) the production of food of animal origin; 
(ii) the use of veterinary medicinal products, including rules on their prohibition or 
authorisation, their distribution, their placing on the market and the rules 
covering administration and inspection;  
EN 15  EN (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 hygiene 
quality of the raw materials used for preparing feedingstuffs and of the final 
product; 
(b) the hygiene conditions of production, manufacture, handling, storage and dispatch 
currently applied to products of animal origin destined for the Union; 
(c) any experience of marketing of the products of animal origin from the third country 
and the results of any official controls on entry in the Union; 
(d) when available, the results of audits carried out by the Commission in the third 
country related to other food-producing animals and goods for which the third 
country is already listed in accordance with Article 127(2) of Regulation (EU) 
2017/625, in particular the results of the assessment of the competent authorities in 
the third country audited, and the action that the competent authorities have taken in 
the light of any recommendations addressed to them following 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 country’s requirements as regards pharmaceutical active substances, 
pesticides and contaminants, in accordance with Article 5. 
Article 5 
Additional requirements for the entry into the Union of food-producing animals, products 
of animal origin and composite products, as regards pharmacologically active substances 
and residues thereof, contaminants and pesticide residues 
1. In addition to the requirements laid down in Regulation (EU) 2017/625, 
consignments of food-producing animals, products of animal origin and composite 
products, shall enter the Union only from a third country that has in place a control 
plan setting out guarantees as regards compliance with: 
(a) the Union requirements on the use of pharmacologically active substances, the 
maximum residue limits of pharmacologically active substances, maximum 
residue levels of pesticides and maximum levels of contaminants established in 
the Union; and 
(b) the additional requirements specified in Articles 8 to 12 of this Regulation. 
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 country in the list 
referred to in Article 126(2), point (a), of that Regulation only if that third country 
provides evidence and guarantees of compliance with the requirements laid down in 
paragraph 1, together with the information listed in Part II of Annex I to this 
Regulation, in the request for inclusion in the list of third countries which that third 
country is to submit under Article 127(2) of Regulation (EU) 2017/625. 
3. After having approved the inclusion of the third country in the list of authorised third 
countries, the Commission shall ensure, in accordance with Article 127(3) of 
Regulation (EU) 2017/625, that the third country continues to comply with the 
requirements laid down in paragraph 1 of this Article.  
EN 16  EN 4. For the purposes of paragraph 3, the Commission shall take into account the updated 
evidence and guarantees of compliance with the requirements laid down in paragraph 
1, which includes information on the third country’s control plan set out in Annex I, 
submitted by that third country by 31 March of each year. 
Article 6 
Inclusion of a third country in a list of third countries that comply with Union 
requirements on pharmacologically active substances 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 composite products, shall enter the Union 
only from a third country that complies with the requirements provided for in Article 5(1) and 
is included in the list of third countries approved for the entry into the Union of the concerned 
food-producing animals or products of animal origin for human consumption, set out in 
Annex -I to Implementing Regulation (EU) 2021/405.  
Article 7 
Derogation from the requirements for the entry into the Union of food-producing animals, 
products of animal origin and composite products 
1. By way of derogation from Article 6, consignments of food-producing animals, 
products of animal origin and composite products may enter the Union from third 
countries that do not have an approved control plan but ensure that the food-
producing animals and products of animal origin, including those used as ingredients 
in the composite products entering the Union, originate in a Member State or a third 
country 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 country in the list 
referred to in Article 126(2), point (a), of that Regulation only if the competent 
authority of that third country provides the Commission with evidence and 
guarantees of compliance with the requirements laid down in paragraph 1. Such 
evidence and guarantees shall consist of information on the procedures in place in 
that third country to guarantee the traceability and origin of those food-producing 
animals and those products of animal origin.. 
3. Where a third country is included, in accordance with paragraphs (1) and (2), in the 
list of authorised third countries for specific food-producing animals or products of 
animal origin, the entry for this country shall be associated with the following note: 
 (a) ‘Third country, only entering the Union specific food-producing animals or 
products of animal origin – as such or as ingredients of composite products –, which 
originate: (a) from other third countries authorised for the entry into the Union of 
such food-producing animals or such products of animal origin, or (b) from Member 
States, in accordance with Article 7 of Commission Delegated Regulation (EU) 
2022/… [ Publications Office: please insert in the text the number of this 
Regulation ].’ 
[or, for third countries that are not allowed to be listed with note (a) because of non-
compliance with animal health requirements,]  
EN 17  EN (b) ‘Third country, only entering the Union composite products containing processed 
products of animal origin, which originate: (a) from other third countries authorised 
for the entry into the Union of such food-producing animals or products of animal 
origin, or (b) from Member States, in accordance with Article 7 of Commission 
Delegated Regulation (EU) 2022/… ( Publications Office please insert in the text the 
number of this Regulation ).’ 
4. For the production of casings intended for export to the Union, third countries may 
use  raw material of animal origin imported from other third countries or regions 
thereof which are authorised for the entry into the Union of fresh meat, or of certain 
meat products and treated stomachs, bladders and intestines, and which are listed in 
the relevant lists of such fresh meat and meat products of Implementing Regulations 
(EU) 2021/40431 or 2021/405  and are listed in Annex -I to Implementing Regulation 
(EU) 2021/405 for casings. In addition, the establishments from which the casings 
are to be exported to the Union shall be listed in accordance with Article 13(1) of this 
Regulation. 
5. After having approved the inclusion of the third country in the lists of authorised 
third countries referred to in this Article, the Commission shall ensure, in accordance 
with Article 127(3) of Regulation (EU) 2017/625, that the third country continues to 
comply with the requirements laid down in paragraph 1 of this Article. 
 
CHAPTER III: Conditions for the entry into the Union as regards 
the use of pharmacologically active substances and residues 
thereof, contaminants and pesticide residues 
Article 8 
Requirements as regards the use of pharmacologically active substances in food-producing 
animals and of residues of those substances in products of animal origin for human 
consumption and composite products 
1. Food-producing animals, products of animal origin and composite products shall 
only enter the Union from third countries which provide guarantees that the controls 
on the use of pharmacologically active substances referred to in Annex I to 
Commission Delegated Regulation 2022/x (C(2022)4400) [and the residues of those 
substances are at least equivalent to those required for the multiannual national 
control plans of Member States, as referred to in Article 4 of Implementing 
Regulation 2022/xx (C(2022)4401). 
2. Where a third country authorises the use in food-producing animals of 
pharmacologically active substances which are not authorised for such animals in the 
Union, food-producing animals, products of animal origin and composite products 
shall only enter the Union insofar as that third country provides guarantees that no 
residues of those substances are present in those animals and products. The methods 
 
31 Commission Implementing Regulation (EU) 2021/404 of 24 March 2021 laying down the lists of third 
countries, territories or zones thereof from which the entry into the Union of animals, germinal products 
and products of animal origin is permitted in accordance with Regulation (EU) 2016/429 of the 
European Parliament and of the Council (OJ L 114, 31.3.2021, p. 1). 
  
EN 18  EN of analysis used to demonstrate the absence of such residues shall comply with the 
requirements laid down in Annex I to Implementing Regulation (EU) 2021/808 or 
with requirements equivalent thereto. 
Article 9 
Requirements as regards the prohibition of certain substances 
1. Food-producing animals, products of animal origin and composite products shall 
only enter the Union from third countries which provide guarantees of compliance 
with the prohibition of the use of beta-agonists and any stilbene, thyrostatic, 
oestrogenic, androgenic and gestagenic 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 composite products from 
third countries that authorise the use of the substances referred 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 countries provide guarantees that: 
(a) they have set up a segregated production system to ensure that food-producing 
animals, products of animal origin and composite products intended for entry 
into the Union are not treated with the substances referred to in paragraph 1, 
and 
(b) they have set up an appropriate animal identification and traceability system, as 
well as a system for the control of the distribution of the substances referred to 
in paragraph 1 and for the record keeping of the administration of veterinary 
medicinal products. 
 
Article 10 
Requirements as regards residues of pesticides in food of animal origin and composite 
products 
Products of animal origin and composite products shall only enter the Union from third 
countries which provide guarantees that representative controls on pesticide residues are 
performed in order to demonstrate that those products comply with the maximum residue 
levels laid down in Regulation (EC) No 396/2005. Those guarantees shall be at least 
equivalent to those provided for by the multiannual national control programmes for pesticide 
residues referred to in Implementing Regulation 2021/1355. 
Article 11 
Requirements as regards contaminants in food of animal origin and composite products 
Products of animal origin and composite products shall only enter the Union from third 
countries which provide guarantees that those products comply with the maximum tolerances 
for contaminants established on the basis of Regulation (EEC) No 315/93. Those guarantees 
shall be at least equivalent to those provided for by the multiannual national control plans 
established in accordance with Delegated Regulation 2022/931 and Implementing Regulation 
2022/932  
Article 12 
Application of Article 5 to 11  
EN 19  EN 1. The requirements referred to in Articles 5 to 11 shall apply to the entry into the Union of 
the following food-producing animals, products of animal origin and composite products:  
(a) live animals for which Combined Nomenclature codes (‘CN codes’) have been 
laid down in Part Two, Chapter 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, Chapters 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 headings 0901, 3501, 3502 and 3504; 
(c) dead whole insects, parts of insects or processed insects; and 
(d) composite products for which CN codes have been laid down in Part Two, 
Chapters 15 to 22, of Annex I to Regulation (EEC) No 2658/87. 
2. However, the requirements referred to in Articles 5 to 11  shall not apply to gelatine 
referred to in Section XIV of Annex III to Regulation (EC) 853/2004, raw materials 
for the production of gelatine referred to in Section XIV, Chapter I, point 1 of that 
Regulation, collagen referred to in Section XV of that Regulation, raw materials for 
the production of collagen referred to in Section XV, Chapter I, points 1 of that 
Regulation, and highly refined products referred to in Section XVI, point 1, of that 
Regulation.  
 
 
CHAPTER IV: Conditions for the entry into the Union as regards 
establishments 
Article 13 
Requirements for establishments  
1. Consignments of the following goods shall only enter the Union where those 
consignments are dispatched 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: 
(a) products of animal origin, for which requirements are laid down in Annex III to 
Regulation (EC) No 853/2004, and 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 Chapters 2 to 5, 15 or 16; or 
(ii) HS subheadings 1702, 2105, 2106, 2301, 2932, 3001, 3002, 3501, 
3502, 3503, 3504, 4101, 4102 or 4103; 
(b) sprouts falling under the following HS subheadings: 0704 90, 0706 90, 0708 
10, 0708 20, 0708 90 or 1214 90 of 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 
referred to in Article 127(3), point (e), of Regulation (EU) 2017/625 only if, in 
addition to the guarantees laid down in Article 127(3), points (e)(ii) and (iv), of  
EN 20  EN Regulation (EU) 2017/625, the third country where the establishments are located 
provides the following guarantees: 
(a) such establishments, together with any establishments handling raw material of 
animal origin used in the manufacture of the products of animal origin referred 
to in paragraph 1(a), comply with applicable requirements referred 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 appropriate, only handle raw materials of animal 
origin that come from third countries with an approved residue monitoring plan 
for that product category in accordance with Delegated Regulation (EU) 
2022/xxxx (C(2022) 4400) and Implementing Regulation (EU) 2022/xxx 
(C(2022) 4401 or from Member States; 
(c) it has real powers to stop such establishments from exporting to the Union 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 competent authorities of the third country in accordance with 
Article 127(3), point (e)(iii), of Regulation (EU) 2017/625 and shall publish such 
lists on its website. 
4. Member States shall only allow the entry into the Union of the consignments referred 
to in paragraph 1 provided that the official certificates which are required to 
accompany such consignments pursuant to the applicable Union rules are issued by 
the competent authorities of the third country starting with the date of publication, by 
the Commission, of the establishment in the lists referred to in paragraph 1. 
Article 14 
Establishments not subject to the requirements of Article 13(1)  
The requirements laid down in Article 13 shall not apply to establishments that only carry out 
the following activities: 
(a) primary production; 
(b) transport operations; 
(c) storage of products of animal origin not requiring temperature-controlled storage 
conditions; 
(d) production of highly refined products referred to in Section XVI of Annex III to 
Regulation (EC) No 853/2004 and referred to by HS subheadings 2930, 2932, 3503, 
3507 or 3913 of Part Two of Annex I to Regulation (EEC) No 2658/87. 
(e) Gelatine capsules referred to by subheadings 3913, 3926 or 9602 of Part Two of 
Annex I to Regulation (EEC) No 2658/87. 
 
CHAPTER V: Additional requirements for the entry into the 
Union of certain goods intended for human consumption 
Article 15 
Requirements for consignments of fresh meat, minced meat, meat preparations, meat  
EN 21  EN products, mechanically separated meat and raw materials intended for the production 
of gelatine and collagen 
Consignments of the following products of animal origin shall only enter the Union if they 
have been manufactured from raw materials obtained in slaughterhouses, game-handling 
establishments, cutting plants and establishments handling fishery products, appearing 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 Delegated Regulation (EU) No 2020/69232; 
(e) raw materials intended for the production of gelatine and collagen referred to 
respectively in Section XIV, Chapter I, point 4(a), and in section XV, Chapter I, 
point 4(a), of Annex III to Regulation (EC) No 853/2004. 
Article 16 
Requirements for consignments of live bivalve molluscs, 
echinoderms, tunicates and marine gastropods 
1. Notwithstanding Article 14 of this Regulation, consignments of live bivalve 
molluscs, echinoderms, tunicates and marine gastropods for which CN codes have 
been laid down in heading 0307 of Part Two of Annex I to Regulation (EEC) No 
2658/87 shall enter the Union only from production areas in third countries that 
appear on lists drawn up by the competent authorities of the third country in 
accordance with Article 127(3), point (e), of Regulation (EU) 2017/625 and 
published by the Commission. 
2. The following products may enter the Union, even if harvested in areas which have 
not been classified by the competent authorities in the third country of production in 
accordance with Article 18(6) of Regulation (EU) 2017/625: 
(a) Pectinidae , except where data from monitoring programmes established by 
Article 57 of Implementing Regulation (EU) 2019/627 enable the competent 
authorities to classify fishing grounds as set out in Section VII, Chapter IX, 
point 2, of Annex III to Regulation (EC) No 853/2004; 
(b) marine gastropods that are not filter feeders and  echinoderms 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 
competent authorities of the third country, particular account shall be taken of the 
guarantees that the competent authorities of the third country can give concerning 
 
32 Commission Delegated Regulation (EU) 2020/692 of 30 January 2020 supplementing Regulation (EU) 
2016/429 of the European Parliament and of the Council as regards rules for entry into the Union, and 
the movement and handling after entry of consignments of certain animals, germinal products and 
products of animal origin (OJ L 174, 3.6.2020, p. 379).  
EN 22  EN compliance with the requirements of Article 52 of Implementing Regulation 
2019/627 on the classification and control of production areas. 
2. The Commission shall carry out an on-the-spot control visit before the lists referred 
to in Article 16(1) are drawn up. 
3. Once lists referred to in Article 16(1) are drawn up, and when the competent 
authorities of the third country offer sufficient guarantees on the management and 
controls of production areas under their responsibility, the on-the-spot Commission 
control visit need not 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 fishery products 
Consignments of fishery products for which CN codes have been laid down in headings 0301, 
0302, 0303, 0304, 0305, 0306, 0307, 0308, 0309, 1504, 1516, 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 market 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 stored in a cold-store or 
a reefer 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 189  
Special requirements for listing vessels  
1. A vessel may be included on the lists of establishments referred to in Article 127(3), 
point (e)(ii), of Regulation (EU) 2017/625 provided that the competent authorities of 
the third country whose flag the vessel is flying, and the competent authorities of 
another third country to which the competent authorities of the third country whose 
flag the vessel is flying have delegated responsibility for the inspection of the vessel 
concerned, provide the Commission with a joint communication stating that all of the 
following requirements are met: 
(a) both third countries appear on the list of third countries or regions thereof, 
drawn up in accordance with Article 127(3) of Regulation (EU) 2017/625, 
from which entry into the Union of fishery products is permitted; 
(b) all fishery products from the vessel concerned that are destined for placing on 
the market in the Union are landed directly in the third country to which the 
third country whose flag the vessel is flying has delegated responsibility for the 
inspection of the vessel concerned; 
(c) the delegated competent authorities have inspected the vessel and have 
declared that it complies with the applicable Union requirements; 
(d) the delegated competent authorities have declared that they will regularly 
inspect the vessel to ensure that it continues to comply with the applicable 
Union requirements. 
2. A vessel may be included on 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 competent authorities of the third country whose flag the vessel is flying 
and from the competent authorities of a Member State, to which the competent  
EN 23  EN authorities of the third country whose flag the vessel is flying have delegated 
responsibility for the inspection of the vessel concerned, if all of the following 
requirements are met: 
(a) all fishery products from the vessel concerned that are destined for placing on 
the market in the Union are landed directly in that Member State; 
(b) the competent authorities of that Member State have inspected the vessel and 
have declared that it complies with the applicable Union requirements; 
(c) the competent authorities of that Member State have declared that they will 
regularly inspect the vessel to ensure that it continues to comply with the 
applicable Union requirements. 
Article 20 
Requirements for consignments of composite products 
1. Consignments of composite products referred 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 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 composite 
products was either produced in establishments that are located in third countries or 
regions thereof and authorised to export those processed products of animal origin to 
the Union 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 countries or 
regions thereof authorised to export composite products to the Union, consignments 
of composite products from third countries or regions thereof may enter the Union, 
subject to compliance with the following rules: 
(a) composite products referred to in paragraph 1 that need to be transported or 
stored under controlled temperatures shall originate from third countries or 
regions thereof authorised, under Article 3, to export to the Union each 
processed product of animal origin contained in the composite products; 
(b) composite products referred to in paragraph 1 that do not need to be 
transported or stored under controlled temperatures and that contain any 
quantity of colostrum-based products or processed meat, shall originate from 
third countries or regions thereof authorised, under Article 3, to export to the 
Union the colostrum-based products or meat products contained in the 
composite products; 
(c) composite products referred to in paragraph 1 that do not need to be 
transported or stored under controlled temperatures and that contain processed 
products of animal origin other than colostrum-based products or processed 
meat, for which requirements are laid down in Annex III to Regulation (EC) 
No 853/2004, shall originate from third countries or regions thereof that are 
authorised, under Article 3, to export meat products, dairy products, fishery 
products or egg products to the Union on the basis of Union animal and public 
health requirements and are listed at least for one of these products of animal 
origin.  
EN 24  EN 3. The third countries or regions thereof exporting composite products to the Union  
shall be listed in Annex -1 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 composite products, with the exception of collagen, gelatine and the 
highly refined products listed in Section XVI, point 1, of Annex III to Regulation 
(EC) No 853/2004, are derived. 
4. Paragraphs 2 and 3 shall not apply to shelf-stable composite products that only 
contain processed products of animal origin or composite products that fall under the 
scope of Regulation (EC) No 1332/2008 of the European Parliament and of the 
Council33, Regulation (EC) No 1333/2008 of the European Parliament and of the 
Council 34, Regulation (EC) No 1334/2008 of the European Parliament and of the 
Council 35, or that only contain vitamin D3. 
 
CHAPTER VI: Conditions for the entry into the Union as regards 
certification and attestation 
Article 21 
Official certificates 
1. Each consignment of the following products shall enter the Union only where the 
consignment is accompanied by an official certificate except in case of consignments 
for which the Union is not the final destination: 
(a) products of animal origin intended for human consumption, 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 Chapters 2 to 5, 15, 16 or 29; or 
(ii) HS subheadings 0901, 1702, 2105, 2106, 2301, 3001, 3002, 3501, 
3502, 3503, 3504, 3507, 3913, 3926, 4101, 4102, 4103 or 9602; 
(b) live insects referred to by the CN code 0106 49 00 of Part Two of Annex I to 
Regulation (EEC) No 2658/87; 
(c) sprouts and seeds intended for the production of sprouts and referred to by the 
following 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 91 or 1214 90 of Part Two of Annex I to Regulation (EEC) No 
2658/87; 
 
33 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 on food 
additives (OJ L 354, 31.12.2008, p. 7). 
34 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). 
35 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 properties 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 25  EN (d) pollen flour referred to by the CN code 1212 99 95 of Part Two of Annex I to 
Regulation (EEC) No 2658/87; 
(e) live snails, other than sea snails, referred to by the CN code 0307 60 00 of Part 
Two of Annex I to Regulation (EEC) No 2658/87; 
(f) composite products referred to in Article 20(2), points (a) and (b), of this 
Regulation, with the exclusion of shelf-stable composite products that do not 
contain colostrum-based products or processed meat other than gelatine, 
collagen or highly refined products referred to in Section XVI of Annex III to 
Regulation (EC) No 853/2004. 
2. When consignments of fishery products enter the Union directly from a reefer, 
factory or a freezer vessel flying the flag of a third country, the official certificate 
referred to in Article 14(3) of Implementing Regulation (EU) 2020/2235 may be 
signed by the captain. 
3. No official certificate is necessary for the entry into the Union of gelatine capsules 
covered by HS subheadings 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 referred to in paragraph 1 shall certify that the products 
comply with: 
(a) the requirements laid down in Regulations (EC) No 178/2002, (EC) 
No 852/2004 and (EC) No 853/2004 or provisions recognised to be equivalent 
to those requirements; 
(b) any specific requirements for entry into the Union set out in this Regulation. 
5. The official certificates referred 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 intended for the production of sprouts 
referred to in paragraph 1(c) shall accompany 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 accompany each part of the 
consignment. 
7. The competent authorities of the third country of dispatch may certify consignments 
of products of animal origin that only require public health attestation, or 
consignments of sprouts, coming from another third country, if the competent 
authorities of the third country of dispatch can ensure compliance of the 
consignments with the requirements for entry into the Union laid down in this 
Regulation. 
Article 22 
Private attestation 
1. A private attestation confirming that the consignments comply with the applicable 
requirements referred to in Article 126(2) of Regulation (EU) 2017/625, prepared 
and signed by the importing food business operator, shall accompany: 
(a) the consignments of the composite products referred to in Article 20(2), 
point (b) of this Regulation, where the composite products do not contain 
colostrum-based products or processed meat other than gelatine, collagen or  
EN 26  EN highly refined products referred to in Section XVI of Annex III to Regulation 
(EC) No 853/2004; and 
(b) the consignments of the composite products referred to in Article 20(2), 
point (c). 
2. By way of derogation from paragraph 1, for the 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 accompany the products at 
the time of the placing on the market. 
3. The private attestation referred to in paragraph 1 shall ensure the traceability of the 
consignment and shall include: 
(a) information regarding the consignor and consignee of the imported goods; 
(b) the list of products of plant origin and processed products of animal origin 
contained in the composite products, indicated in descending order of weight, 
as recorded at the time of their use in the manufacture of the composite 
product; 
(c) the approval number of the establishment(s) manufacturing the processed 
products of animal origin contained in the composite product, as provided for 
in Article 4(2) of Regulation (EC) No 853/2004 and indicated by the importing 
food business operator. 
4. The private attestation referred to in paragraph 1 shall attest that: 
(a) the third country or region thereof producing the composite product is listed at 
least for one of the following categories of products of animal origin: 
(i) meat products; 
(ii) dairy products or colostrum-based products; 
(iii) fishery products; 
(iv) egg products; 
(b) the establishment producing the composite products fulfils hygiene standards 
recognised to be equivalent to those required by Regulation (EC) No 852/2004; 
(c) the composite product does not need to be stored or transported under 
controlled temperature; 
(d) the processed products of animal origin contained in the composite product 
originate from third countries or regions thereof authorised to export each 
processed product of animal origin to the Union, or from the Union, and are 
sourced from a listed establishment or listed establishments; 
(e) the processed products of animal origin used in the composite product have 
undergone at least one of the treatments referred to in Article 163, point (a), of 
Delegated Regulation (EU) 2020/692, with a brief description of any processes 
undergone and temperatures applied to the composite product. 
  
EN 27  EN CHAPTER VII: Final provisions 
Article 23 
References 
References to Article 29 of Directive 96/23/EC shall be construed as references to this 
Regulation. 
Article 24 
Repeal 
Delegated Regulation (EU) 2019/625 is repealed. 
References to the repealed Delegated Regulation shall be construed as references to this 
Regulation and shall be read in accordance with the correlation table in Annex II. 
Article 25 
Entry into force and application  
This Regulation shall enter into force on the twentieth day following 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, 
 For the Commission 
 The President 
 Ursula VON DER LEYEN