EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10279/2018 CIS Rev. 1 
(POOL/G4/2018/10279/10279R1 -EN 
CIS.doc)  
[…](2018) 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 to be respected by consignments of certain animals 
and goods intended for human consumption entering the Union  
(Text with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 1  EN EXPLANATORY MEMORANDUM  
1. LEGAL  CONTEXT  OF THIS  DELEGATED  REGULATION  
Regulation (EU) 2017/625 of the European Parliament and of the Council1 lays down rules 
for the performance of official controls and other control activities by the competent 
authorities of the Member States . It also sets out the  requirements  to be fulfilled for the entry 
into the EU of consignments of animals and goods from ‘third countries ’ (i.e. countries 
outside the EU) , and it empowers the Commission to adopt  delegated acts concerning those 
requirement s. 
This Delegated Regulation supplements  the requirements  for the entry into the EU of 
consignments of certain food s intended for human consumption , laid down in (Article 125 of) 
Regulation (EU) 2017/625 . These requirements  are based on the risks that certain foods may 
pose to public health . Their purpose is  to ensure that consignments of food from third 
countries compl y with requirements laid down in EU legislation, or with requirements 
recognised to be at least equivalent to  this legislation . 
The requirements  laid down in this  Delegated Regulation are largely based on the rules 
already laid down in current EU legislati on, in particular in the requirements of three legal 
acts: 
 Chapter III on procedures concerning imports of Regulation (EC) No 854/2004 of 
the European Parliament and of the Council2; 
 Article 48 on specific import requirements  in Regulation No 882/2004 of t he 
European Parliament and of the Council3. Both of these pieces of legislation are 
repealed by Regulation (EU) 2017/625 ; 
 Commission Regulation (EU) 211/20134. 
Transitional  measures are laid down for the entry into the Union of certain food until 
31 December 2020] in accordance with Commission Regulation (EU) 2017/1855. 
The requirements  set out in this draft delegated regulation consist of a three -tiered system of 
guarantees consisting of the following requirements : 
                                                 
1 Regulation  (EU) 2017/625 of the European Parliament and of 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 1/200 5 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, 89/6 62/EEC, 60/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council 
Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1).  
2 Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29  April 2004 laying 
down specific rules for the organisation of official controls on products of animal origin intended for 
human consumption (OJ L 139 , 30.4.2004, p. 206).  
3 Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29  April 2004 on 
official controls performed to ensure the verification of compliance with food and feed law, animal 
health and animal welfare rules (OJ L 165, 30.4.2004, p. 1).  
4 Commission Regulation (EU) No 211/2013 of 11  March 2013 on certification requirements for imports 
into the Union of sprouts and seeds intended for the production of sprouts (OJ L 68, 12.3.2013, p. 26).  
5 Commission Regulation (EU) 2017/185 of 2  February 2017 laying down transitional measures for the 
application of certain provisions of Regulations (EC) No 853/2004 and (EC)  No 854/2004 of the 
European Parliament and of the Council (OJ L 29, 3.2.2017, p. 21).   
EN 2  EN (a) requirements  for the listing of third countries or regions thereof authorised for 
imports of food into the European Union . Third countries or regions in these third 
countries  are included in those lists through an implementing regulation in 
accordance with Article  127 of Regulation (EU) 2017/625 . 
(b) the requirement  that consignments of certain animals and goods from third countries 
must be dispatched from, and obtained or prepared in establishments which comply 
with relevant requirements referred to in Article  1(2)(a)  of Regulation (EU) 
2017/625 , or with requirements recognised to be at least equivalent thereto and listed 
in accordance with this Regulation . 
(c) the requirement that consignments be accompanied by appropriate official 
certification confirming their  compliance with relevant requirements applicable in 
the EU.  
Additional specific import requirements  for bivalve molluscs, fishery products and composite 
products have  also been included. The import requirements  laid down in this delegated 
regulation take i nto account  (as do the existing rules laid down in Regulation (EC) 
No 854/2004 ) the specific characteristics of certain products, for example, fishery products 
and molluscs . They also take into account  the need for greater flexibility when certain 
products  pose a lower level of risk to public and animal health.  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  DELEGATED  
REGULATION  
The Commission invited representatives of the European Parliament and of the Member 
States to attend expert -group meetings during th e preparation of the draft delegated 
regulation.  
In addition, private stakeholders’ organisations were consulted as part of the Advisory Group 
on the Food Chain and Animal and Plant Health.  
Third countries were informed by notification to the World Trade O rganisation within the 
framework of the Agreement on the Application of Sanitary and Phytosanitary Measures (the 
SPS Agreement).  
Finally, before adopting  this Delegated R egulation the Commission conducted  open and 
transparent public consultations in accord ance with the procedures laid down in the Inter -
institutional Agreement on Better Law -Making6. 
3. LEGAL  BASIS  OF THE  DELEGATED  REGULATION  
This delegated regulation will be adopted pursuant to Article  126(1) of Regulation (EU) 
2017/625. This initiative is n ecessary as Regulation (EU) 2017/625 repeals Regulation (EC) 
No 854/2004 and Regulation (EC) No 882/2004 of the European Parliament and of the 
Council with effect from 14  December 2019  and for certain products, it is necessary to 
establish requirements for their entry  into the Union . 
                                                 
6 http://ec.europa.eu/smart -regulation/better_regulation/documents/iia_blm_final_en.pdf.   
EN 3  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
supplementing Regulation (EU) 2017/625 of the European Parliament and of the 
Council with regard to requirements  to be  respected by consignments of certain animals 
and goods intended for human consumption entering the Union  
(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 of 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 p roducts, 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, 60/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and 
Council Decision 92/438/EEC (Official Controls Regulation)7, and in particular 
Article  126(1) thereof,  
Whereas:  
(1) Regulation (EU) 2017/625 lays down rules for the performance of official control s and 
other official activities by the competent authorities of the Member States, including  
for the establishment of requirements  to be fulfilled for the entry into the Union of 
consignments of animals and goods from third countries or regions ther eof and official 
control s performed on such consignments that are intended for human consumption in 
order to ensure that they comply with Union legislation in the area of food and food 
safety  in accordance with its Article 12 6 thereof . 
(2) Regulation (EU) 2017 /625 provides a legal basis to supplement the requirements  for 
entry into Union of with additional requirement s for certain animals and goods. These 
additional requirements  include guarantees concerning  the verification of compliance 
with: 
– the measures to monitor substances and groups of residues in animals and 
goods intended for human consumption in accordance with Council Directive 
96/23/EC8;  
                                                 
7 OJ L 95, 7.4.2017, p. 1.  
8 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 4  EN – the rules for the prevention, control and eradication of transmissible 
spongiform encephalopathies (TSEs) in l ive animals and products of animal 
origin  in accordance with Regulation (EC) No 999/2001 of the European 
Parliament and of the Council9;  
– 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 Council10;  
– 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 Council11;  
– 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 Council12; and, 
– the specific rules on official controls and for acti on taken by the competent 
authorities in relation to production of products of animal origin intended for 
human consumption in accordance with Commission Delegated Regulation 
(EU) [SANTE /10193/ 2017]13 and Commission Implementing Regulation (EU) 
[SANTE /10194/ 2017]14. 
Moreover, these additional requirements include guarantees given by the third 
country concerning establishments from which goods are exported to the Union 
referred to in recital 13.  
(3) Regulation (EC) No 854/200415 laid down specific conditions for the entry into the 
Union of products of animal origin intended for human consumption, while Regulation 
(EC) No 882/200416 laid down the general  conditions for the entry into the Union of 
any food.  Regulation (EU) 2017/625 lays down rules in areas curren tly covered by 
                                                 
9 Regulation (EC) No 999/2 001 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).  
10 Regulation (EC) No 178/2002 of the European P arliament 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 matter s of food safety (OJ L 31, 1.2.2002, p. 1).  
11 Regulation (E C) 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). 
12 Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29  April 2004 laying 
down specific hygien e rules for food of animal origin (OJ L 139, 30.4.2004, p. 55).  
13 Commission Delegated Regulation (EU) …, of ../../…  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 …, ../../…, p. ..) . 
14 Commission Implementing Regulation (EU) …. of ../../…. 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) 201 7/625 of the European Parliament and of the Council and 
amending Commission Regulation (EC) No 2074/2005 as regards official controls  (OJ L …, ../../…., 
p. ..). 
15 Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29  April 2004 la ying 
down specific rules for the organisation of official controls on products of animal origin intended for 
human consumption (OJ L 139 , 30.4.2004, p. 206).  
16 Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29  April 2004 on 
official controls performed to ensure the verification of compliance with feed and food law, animal 
health and animal welfare rules (OJ L 165 , 30.4.2004, p. 1).   
EN 5  EN those two Regulations  and it  repeal s them  and replac es them with effect from 
14 December 2019 .  
(4) The requirements laid down in this Regulation should ensure a continuation of the 
requirements laid down in Regulations (EC) No 854/2004 and (EC)  No 882/2004  to 
ensure a high level of protection of health and  in order to a avoid a disruption of the 
entry into the Union  of consignments of certain animals and goods intended for human 
consumption . At the same time the experience gained in the applicat ion of the rules 
laid down in those two Regulations  should be taken into account  using a risk -based 
approach .  
(5) 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.  
(6) Commission R egulatio n (EU) 2017/18517 provid es for derogations  concerning  public 
health requirements for the imports  of certain products of animal origin (such as 
insects and reptile meat) and food containing both products of plant origin and 
processed products of animal origin (composite products)  until 31 December 2020 . In 
order to ens ure a high level of protection of health, requirements for the entry into the 
Union  of such products  should also be laid down before the end of the transitional 
measures in order to verify  of compliance with Union rules covering these products .  
(7) Insects ar e increasingly produced for human consumption. It should be ensured that 
imported insects comply with the Union requirements for food and food safety. The 
additional requirements  laid down in this Regulation for the entry into the Union of 
consignments of products of animal origin should therefore al so apply to insects . Since 
dead insects, parts of insects and processed insects are also subject to authorisation as 
novel food in accordance with Regulation (EU) 2015/2283 of the European Parliament 
and of the Council18, certification of compliance with that Regulation should also be 
introduced as additional requirements for the entry into th e Union  of those products.  
(8) On 18  October 2007, the European Food Safety Authority adopted an Opinion on the 
public health risks involved in the human consumption of reptile meat 19. A number of 
hazards  such as Salmonella and Trichinella  were identified. Requirements for the 
entry into the Union should include verification of compliance with the Union 
requirements to reduce the risk from  these hazards in consignments of reptile meat .  
(9) The composition of composite products affects the physico -chemical charact eristics of 
such foods, leading to different risks. For this reason, only consignments of composite 
products which comply with appropriate requirements, notably on the origin of the 
processed products of animal origin that compose such foods, the origin of  the food 
itself, or the guarantees that accompany the consignments of composite products , 
should be authorised for enter into the Union . For composite products that pose  a low 
                                                 
17 Commission Regulation (EU) 2017/185  of 2 February 2017 laying down transitional measures for th e 
application of certain provisions of Regulations (EC) No 853/2004 and (EC) No 854/2004 of the 
European Parliament and the Council (OJ L 29, 3.2.2017, p. 21) . 
18 Regulation (EU) 2015/2283 of the European Parliament and 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. ). 
19 http://www.efsa.europa.eu/en/efsajournal/pub/578   
EN 6  EN risk to human health , this Regulation should provide for derogation s from check s at 
the border control posts . 
(10) 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 in accordance with Council Regulation (EEC) 
No 2658/8720 to clearly identify these goods and animals.  
(11) Consignments of certain animals and goods intended for human consumption should 
only be allowed to enter the Union, based on a risk analysis, when the third countries 
or regions the reof from which the foods originate can ensure compliance with the 
requirements  on the safety of the food  and they are duly listed in Commission 
Implementing Regulation (EU) [SANTE/10280/2018 ]21, adopted pursuant to Article 
127(2) of Regulation (EU) 2017/62 5. 
(12) In addition to the requirements in Article 127(3) of Regulation (EU) 2017/625, 
specific requirements should be laid down for c ertain animals and goods intended for 
human consumption in order to provide guarantees as regards  the efficiencies of 
official controls on food safety in  third countries or regions thereof . Third c ountries or 
regions thereof  should only appear on lists after evidence and guarantees have been 
provided that the animals and goods concerned from the third countries or regions 
thereof comply with Union requirements for the safety of food, or with requirements 
equivalent thereto, laid down in Directive 96/23/EC, Regulations (EC) No 999/2001, 
(EC) No 178/2002, (EC) No  852/2004, (EC) No  853/2004, (EU) 2017/625, Delegated 
Regulation (EU) [S ANTE /10193/ 2017] and Implementing Regulation (EU) 
[SANTE /10194/ 2017].  
(13) 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 lists drawn up and kept up to date in 
accordance with Article 127(3)(e) of Regulation (EU) 2017/625  and which are 
published by the Commission . In addition, in order to ensure compliance with Union 
food hygiene rules, or with rules which are  at least equivalent thereto, it is appropriate 
to provide that when drawing up and updating the lists of such establishments referred 
to in Article 127(3)(e) of Regulation (EU) 2017/625 , the third country should give the 
following additional guarantees to  those referred to in Article 127(3)(e) (i) and (iv) of 
Regulation (EU) 2017/625 : 
– establishments from which products of animal origin exported to the Union are 
dispatched from, and obtained or prepared in, together with any establishments 
handling raw material of animal origin used in the manufacture of the products 
of animal origin concerned, comply with relevant Union requirements, in 
particular those of Regulation (EC) No 853/2004, or with requirements which 
are at least equivalent thereto ; 
– the estab lishment, where appropriate, only handles raw materials of animal 
origin that come from third countries with an approved residues monitoring 
                                                 
20 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, 739.1987, p. 1). 
21 Commission Implementing Regulation (EU) …. of ../../…. establishing lists of third countries or regions 
thereof authorised for the entry into the European Union of certain animals and goods intended for 
human consumption and amending Implementing Regulatio n (EU) 2016/759 as regards these lists  
(OJ L …, ../../…., p. ..) .  
EN 7  EN plan for that product category in accordance with Directive 96/23/EC or from 
Member States ; 
– it has real powers to s top the establishments from exporting to the Union in the 
event that the establishments fail to meet the relevant Union requirements or 
requirements which are at least equivalent thereto.  
(14) The Commission should make the aforementioned  lists of establishment s available to 
the public to ensure transparency for food business operators and consumers from 
which establishments such goods may enter the Union for placing on the market.  With 
a view to ensure the effect iveness of these requirements, Member States shou ld allow 
the import of consignments of such goods provided that the official certificates which 
are required to accompany such consignments pursuant to the applicable Union rules 
are issued by the competent authority of the third starting with the date of publication 
by the Commission of the lists. 
(15) Such r equirements concerning establishments should not be establish ed in relation to 
goods intended for transit, since they represent a low risk from a food safety 
perspective and there is no placing on the marke t of animals and goods within the 
Union . In addition, such requirements  should not be establish ed for 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 chondroitin sulphate, hyaluronic acid, other hydrolysed 
cartilage products, chitosan, glucosamine, rennet, isinglass and amino acid s referred to 
in Section XVI of Annex III to Regulation (EC) No 853/2004.  
(16) Commission regulation (EU) No 210/201322 requires the establishments producing 
sprouts to be approved by the competent authority in accordance with Article 6 of 
Regulation (EC) No 85 2/2004.  In order to ensure compliance with Union food hygiene 
rules, or with rules recognised to be at least equivalent thereto, sprouts produced in 
these establishments should only be allowed entry to the Union if these establishments 
appear on lists draw n-up and updated in accordance with this Regulation.  
(17) In order to ensure compliance with Union food hygiene rules, or with rules at least 
equivalent thereto, products from establishments manufacturing fresh meat, minced 
meat, meat preparations, meat product s, mechanically separated meat  and raw 
materials intended for the production of gelatine or collagen, should only be allowed 
entry to the Union if these establishments appear on lists drawn -up and updated in 
accordance with Article 127(3)(e)  of Regulation (EU) 2017/625 and which are 
published by the Commission. 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)(e)  of 
Regulation (EU) 2017/625 and which are published by the Commission.  
(18) Consignments of live bivalve molluscs, echinoderms, tunicates and marine gastropods 
should only e nter 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)(e) of 
Regulation (EU) 2017/625 and which are published by the Commission,  in order to 
ensure compliance with specific requirements for these products laid down in 
                                                 
22 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 Regulation (EC) No 853/2004 and Implementing Regulation (EU) 
[SANTE /10194/ 2017 ], or with rules which are  at least equivalent thereto. The 
publication of those lists sh ould ensure transparency for food business operators and 
consumers from which production areas live bivalve molluscs, echinoderms, tunicates 
and mari ne gastropods may enter the Union.  
(19) Consignments of fishery products should only be allowed entry into  the U nion when 
the consignments are dispatched from, obtained or prepared in reefer, factory or 
freezer vessels flying the flag of a third country that appear on lists drawn up and 
updated in accordance with Article 127(3)(e) of Regulation (EU) 2017/625 and whi ch 
are published by the Commission, 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) 
[SANTE /10194/ 2017], or wi th 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 from which fishery products may enter the Union.  
(20) The conditions for entry into the Union  of products of animal origin laid down in 
Regulation (EC) No 853/2004 do not apply to composite products. However,  that 
Regulation  requires the food business operators importing composite products to 
ensure that the processed products of animal o rigin contained in such foods satisfy the 
requirements laid down  in that Regulation.  
(21) Based on the number of notifications received in the Rapid Alert System for Food and 
Feed  established by Regulation (EC) No 178/2002 , consignments of certain animals 
and goods placed on the market  for human consumption present an enhanced risk for 
non-compliance with Union requirements on food safety. Consignments of such 
animals and goods placed on the market for human consumption sho uld therefore be 
subject to the individual certification of each consignment for entry into the Union for 
placing on the market. Certification of compliance with  Union requirements may also 
contribute  to remind ing food business operators and the competent authorities of third 
countries and regions thereof of the applicable Union requirements.  In the case of 
transit, the use of the current dedicated transit certificates with animal health 
attestation should remain .  
(22) As Regulation (EU) 2017/625 applies with e ffect from 14  December 2019, this 
Regulation should also apply from that date.  Transitional measures provid ing 
derogations from Regulations (EC) No 853/2004 and (EC) No 854/2004, concerning 
public health requirements for the imports of composite products  have been extended 
in accordance with  Commission Regulation (EU) [SANTE/…/2018 ]23. The import 
requirements  laid down in th is Regulation should therefore apply from  20 April  2021 
for composite products  in order to ensure a smooth transition ,  
HAS ADOPTED THIS  REGULATION:  
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 certain animals and goods intended for 
                                                 
23 Commission Regulation (EU) [SANTE/XXX/2018]  (EU) …/… of XXX laying down transitional 
measures for the application of public health requirements of imports of food containing both products 
of plant origin and processed products of animal origin .  
EN 9  EN human consumption from third countries and regions thereof in order to ensure that 
they comply with the relevant requirements established by the rules referred to in 
Article  1(2)(a) of Regulation (EU) 2017/625  or with requirements recogn ised to be at 
least equivalent  theret o.  
2. The following animals and goods fall outside the scope of this Regulation:  
(a) Animals and goods not intended for human consumption , however when the 
destination of the animals and goods has not be decided at entry into the Union, 
this Regulation applie s; 
(b) Animals and goods intended for human consumption only for transit through 
the Union  without being placed on the market . 
3. The requirements  referred to in paragraph 1 cover:  
(a) the identification of animals and goods subject to  the following  requirements  
for entry into the Union apply : 
(i) the requirement  that those animals and goods shall  come from a third 
country or region thereof  listed in accordance with Article 126(2)(a) of 
Regulation (EU) 2017/625 ; 
(ii) the requirement  to be dispatched from, and obtained  or prepared in, 
establishment s which comply with relevant requirements referred to in 
Article 126(1) of Regulation (EU) 2017/625, or with requirements which 
are at least equivalent thereto and which appear on lists drawn -up and 
updated in accordan ce with Article 127 (3) (e) of Regulation (EU) 
2017/625 and published by the Commission, in accordance with Article 
126(2)( b) of Regulation (EU) 2017/625 ; 
(iii) the requirement  that each consignment  of animals and goods  be 
accompanied by an official certif icate , or official attestation  or any other 
evidence of compliance with the rules referred to in Article 1(2)(a) of 
Regulation (EU) 2017/625 , such as private attestation, in accordance with 
Article 126(2)( c) of Regulation (EU) 2017/625 ; 
(b) requirements  for entry into the Union of certain animals and goods from a third 
country or region thereof , listed in accordance with Article 127(2) of 
Regulation (EU) 2017/625 ; 
(c) requirement s that consignments of certain  goods from third countries be 
dispatched from, an d obtained or prepared in, establishments which comply 
with relevant requirements referred to in Article 126(1) of Regulation (EU) 
2017/625, or with requirements which are at least equivalent thereto and which 
appear on lists drawn -up and updated in accord ance with Article 127 (3) (e) of 
Regulation (EU) 2017/625 a nd published by the Commission, in accordance 
with Article 126(2)(b) of Regulation (EU) 2017/625 ;  
(d) requirements  for the entry into the Union for placing o n the market of  the 
specific following comm odities in addition to the requirements laid down in 
accordance with Article 12 6 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 
or collagen ; 
(ii) live bivalve molluscs, echinoderms, tunicates and marine gastropods;   
EN 10  EN (iii) fishery products;  
(iv) composite products.  
(e) additional requirements for the official certificates , official att estations  and 
private attesta tions  that shall accompany certain animals and good for entry 
into the Union.  
Article  2 
Definitions  
For the purpose of this Regulation, t he following definitions shall apply:  
(1) 'equivalent' means equivalent as defined in point (1)(e) of Article 2 of Regu lation 
(EC) No 852/2004;  
(2) ‘placing on the market’ means placing on the market as defined in point (8) of 
Article 3 of Regulation (EC) No 178/2002 ; 
(3) 'establishment' means establishment as defined in Article 2(c) of Regulation (EC) 
No 852/2004;  
(4) ‘private attestation'  means an attestation signed by the importing food business 
operator ; 
(5) 'fresh meat' means fresh meat as defined in point 1.10 of Annex I to Regulation (EC) 
No 853/2004;  
(6) 'minced meat' means minced meat as defined in point 1.13 of Annex I to Regulation 
(EC) No 853/2004;  
(7) 'meat preparations' means meat preparations as defined in point 1.15 of Annex I to 
Regulation (EC) No 853/2004;  
(8) 'meat products' means meat products as defined in point 7.1 of Annex I to Regulation 
(EC) No 853 /2004;  
(9) 'mechanically separated meat' means mechanically separated meat as defined in point 
1.14 of Annex I to Regulation (EC) No 853/2004;  
(10) 'gelatine' means gelatine as defined in point 7.7 of Annex I to Regulation (EC) 
No 853/2004;  
(11) 'collagen'  means collagen as defined in point 7.8 of Annex I to Regulation (EC) 
No 853/2004;  
(12) 'bivalve molluscs' means bivalve molluscs as defined in point 2.1 of Annex I to 
Regulation (EC) No 853/2004;  
(13) 'fishery  products' means fishery products as defined in point 3.1 of Annex I to 
Regulation (EC) No 853/2004;  
(14) 'composite product' means food containing both products of plant origin and 
processed products of animal origin;  
(15) 'reptiles ' means animals  belong ing to the species Alligator mississippiensis, 
Crocodylus johnstoni, Crocodylus niloticus, Crocodylus porosus , Timon Lepidus, 
Python reticulatus, Python molurus bivittatus  and Pelodiscus sinensis ; 
(16) 'reptile meat' means edible parts  derived from farmed  reptiles, either fresh or 
processed;   
EN 11  EN (17) ‘insects ’ means food consisting of, isolated from or produced from insects or their 
parts  which are  authorised in accordance with Regulation (EU) 2015/2283  and listed 
in the Union list of novel foods , or any live stadia of insects  intended for direct or 
indirect human consumption ; 
(18) 'sprouts' means sprouts as defined in point (a) of Article 2 of Commission 
Implementing Regulation (EU) No 208/201324; 
(19) 'primary production' means primary production as defined in  point (17) of Article 3 
of Regulation (EC) No 178/2002;  
(20) 'slaughterhouse' means slaughterhouse as defined in point 1.16 of Annex I to 
Regulation (EC) No 853/2004;  
(21) 'game -handling establishment means game -handling establishment as defined in 
point 1.18 of Annex I to Regulation (EC) No 853/2004;  
(22) 'cutting plant' means cutting plant as defined in point 1.17 of Annex I to Regulation 
(EC) No 853/2004;  
(23) 'production area' means production area as defined in point 2.5 of Annex I to 
Regulation (EC) No 853/2004;  
(24) 'factory vessel'  means factory vessel  as defined in point 3.2 of Annex I to Regulation 
(EC) No 853/2004 ; 
(25) 'freezing vessel'  means freezing vessel  as defined in point 3.3 of Annex I to 
Regulation (EC) No 853/2004 ; 
(26) 'reefer vessel ' means a vessel equipped to store and transport palletized or loose 
cargo (bulk) goods in temperature controlled holds or chambers ; 
(27) 'food business operator' means food business operator  as defined in point (3) of 
Article 3 of Regulation (EC) No 178/20 02. 
Article  3 
Animals and good s which are required to come from third countries or regions included 
in the list referred to in Article 126(2)(a) of Regulation (EU) 2017/625  
Consignments of the following animals and goods shall enter the Union only from a third 
country or region thereof included in the corresponding list for those animals and goods laid 
down  in Implementing Regulation (EU) [SANTE /10280/ 2018]:  
(a) products of a nimal origin, including reptile meat and dead whole insects, parts of 
insects or processed insects,  for which Combined Nomenclature codes ('CN codes') 
have been laid down in Sections  2 to 5, 15  and 16, and Harmonised System codes 
('HS codes')  1702, 1806, 2102, 2103, 2105, 2106, 2202, 2301, 2822, 2932, 3001, 
3002, 3501, 3502, 3503, 3504, 3507, 3913, 4101, 4102, 4103, 4110 and 9602  of Part 
II of Annex I to Regulation (EEC) No 2658/87,  when these products are intended for 
human consumption;  
(b) live insects re ferred to by the CN code 0106 49 00;  
                                                 
24 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 12  EN Article  4 
Additional requirements  for entry into the Union of certain 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)(a) of that Regulation if the following requirements are recognised  
by the Commission  as being at least equivalent to the rele vant requirements in the Union for 
animals and goods referred to in Article 3 : 
(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;  
(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 fo r 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 controls carried out by the Commission in the third 
country  related to other 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 Commi ssion when applicable ; 
(f) the existence, implementation and communication of a residue control programme  
approved by the Commission when applicable , in accordance with Directive 
96/23/EC . 
Article  5 
Requirements for entry into the Union of certain goods fr om a third country in relation 
to 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 1 27(3)(e) 
(EU) 2017/625  and published by the Commission on its website : 
(a) products of animal origin for which requirements are laid down in Annex III to 
Regulation (EC) No 853/2004, and for which CN codes have been laid down in 
Sections 2 to 5, 15 and 1 6, and 'HS codes'  2102, 2103, 2105, 2106, 2202, 2301, 
2822, 2932, 3001, 3002, 3501, 3502, 3503, 3504, 3507, 3913,  4101, 4102,  
EN 13  EN 4103 and  4110  of Part II of Annex I to Council Regulation (EEC) No 2658/87, 
when these products are inten ded for human consumption ; 
(b) sprouts referred to by the following HS codes:  0704 90, 0706 90, 0708 10, 
0708 20, 0708 90 or 1214 90 . 
2. Establishments referred to in paragraph 1 may be placed on the lists referred to in 
Article 127(3)(e) of Regulation (EU ) 2017/625 only if, in addition to the guarantees 
laid down in Article 127(3)(e) (i) and (iv) of Regulation (EU) 2017/625 , the third 
country gives 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 
concerned, comply with relevant Union requirements, in particular those of 
Regulation (EC) No 853/2004, or with requirements which are at least 
equivalent thereto ; 
(b) the establishmen t, where appropriate, only handles raw materi als of animal 
origin that come from third countries with an approved residues monitoring 
plan for that product category in accordance with Directive 96/23/EC or from 
Member States ; 
(c) it has real powers to stop  the establishments from exporting to the Union in the 
event that the establishments fail to meet the relevant Union requirements or 
requirements which are at least equivalent thereto.  
The Commission shall provide the Member States with any new and updated  
lists that it receives from the competent authority of the third country in 
accordance with Article 127(3)(e)(iii) of Regulation (EU) 2017/625 and shall 
publish such lists on its website.  
Member States shall allow the import 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 authority of the third starting with the date of 
publication by the Commission of  the lists referred to in paragraph 1.  
Paragraph 3 and 4 shall apply also to the areas covered by Articles 7, 8 and 10.  
Article  6 
Establishments not subject to the requirement s of Article 5 (1) 
The requirement s laid down in Article  5 shall not apply  to establishments that only carry out 
the following activities : 
(a) only primary production;  
(b) only transport operations;  or, 
(c) storage of products of animal origin not requiring temperature -controlled storage 
conditions ; 
(d) production of  highly refi ned chondroitin sulphate, hyaluronic acid, other hydrolysed 
cartilage products, chitosan, glucosamine, rennet, isinglass and amino acids referred 
to in Section XVI of Annex III to Regulation (EC) No 853/2004 and referred to by 
the CN codes under the headin g of 2833, ex 3913, 2930, ex 2932, 3507 or 3503 .  
EN 14  EN Article  7 
Requirements for consignments of fresh meat, minced meat, meat preparations, meat 
products, mechanically separated meat and raw materials intended for gelatine or 
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 lis ts 
of establishments  drawn up  and kept up -to-date in accordance with Article 127( 3)(e) of  
Regulation (EU) 2017/625 and published by the Commission on its website  or in 
establishments approved in accordance with Article  4(2) of Regulation (EC) No 853/2004 : 
(a) fresh meat,  
(b) minced meat,  
(c) meat preparations,  
(d). meat products and mechanically separated meat, and  
(e) raw materials intended for the production of gelatine or collagen referred to  
respectively  in point 4(a) of Chapter I of Section XIV and in point 4(a) of Chapter I 
of section  XV of Annex III to Regulation (EC) No 853/2004 . 
Article  8 
Requirements for consignments of live bivalve molluscs, echinoderms, tunicates and 
marine gastropods  
1. Notwithstanding Article 6, c onsignments of live bivalve molluscs, echinoderms, 
tunicates and marine gastropods for which CN codes have been laid down in heading 
0307 of Part II of Annex I to Regulation (EEC) No 2658/87 shall enter the Union 
only from production areas  in third countries that appe ar on lists drawn up in 
accordance with Article 127(3)(e) of Regulation (EU) 2017/625 and published by the 
Commission on its website . 
2. The following products may enter the Union from production areas which have not 
been  classified by the competent authority  in the third country  in accordance with 
Article 18(6) of Regulation (EU) 2017/625 : 
(a) Pectinidae, except where data from official monitoring programmes  as 
established in Article 58 of Implementing Regulation  (EU)  
[SANTE /10194/2017 ] enable the competent authority to classify fishing 
grounds as set out in point (2) Chapter IX of Section VII of Annex III to 
Regulation (EC) No 853/2004 ; 
(b) marine gastropods that are not filter feeders and Holothuroidea  that are not 
filter feeders . 
Article  9 
Listing of production areas  
1. Before the lists referred to in Article 8(1) are drawn up, particular account shall be 
taken of the guarantees that the competent authority of the third country can give 
concerning compliance with the requirements of Article  52 of Implementing 
Regulation [SANTE /10194/ 2017] on the classification and control of production 
areas.   
EN 15  EN The Commission shall carry out an on-the-spot control  visit before  it draws up  such 
lists. 
2. Once lists referred to in Article 8(1) are drawn up, and when the competent 
Authorities of the third country offer sufficient guaran tees on the management and 
controls of production areas under their responsibility , the on -the-spot Union control 
visit need  not to be carried out pr ior to the addition of  a production area to a n 
existing  list established in accordance with Article 5 . 
Article 10 
Special requirements for fishery products  
1. Consignments of fishery products for which CN codes have been laid down in 
headings  0301, 0302, 0303, 0304, 0305, 0306, 0307, 0308, 1504, 1516, 1603, 1604, 
1605 or 2106 of Part II of Annex I to Regulation  (EEC) No 2658/87, shall enter the 
Union  for placing on the market  only if they have been:  
(a) obtained or prepared , at any stage of their production,  in an on -land 
establishment, a factory or freezer vessel, or  
(b) stored in a  coldstore or a reefer vessel   
that appear on a list drawn up and updated in accordance with Article 127(3)(e) of 
Regulation (EU) 2017/625 and published by the Commission on its website . 
2. By way  of derogation from Article  127(3)(e)(iv) of Regulation (EU) 2017/625 , a 
vessel may also be incl uded on the lists of establishments  provided that the 
competent authority of the third country the flag of which the vessel is flying and the 
competent authority of another third country to which the former competent authority 
has delegated responsibility for the inspection of the vessel concerned  provide the 
Commission with a joint communication stating that  all four of the following 
requirements  are met : 
(a) both third countr ies appear on the list of third countries, drawn up in 
accordance with Article  3, from which entry into the Union of fisheries 
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 that third country ; 
(c) the competent authority has inspected the vessel and has declared that it 
complies with Union requirement ; 
(d) the competent authority has declared that it will regularly inspect the vessel to 
ensure that it continues to comply with Union requirements . 
3. By way of derogation from Article 127(3)(e )(iv) of Regulation (EU) 2017/625 , a 
vessel may be included on the lists of establishments  on the basis of a joint 
communication from the competent authority of the third country the flag of which 
the vessel is flying and from the competent authority of a Member State, to which the 
former competent authority has delegated responsibility for the inspection of the 
vessel concerned, if all three 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 authority of that Member State has inspected the vessel and has 
declared that it complies with Union requirements ;  
EN 16  EN (c) the competent authority of that Member State has declared that it will regularly 
inspect the vessel to ensure that it continues to comply with Union 
requirements.  
4. 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 of ficial certificate 
referred to in Article 1 2(1)(a) may be  signed by the captain.  
Article  11 
Requirements for consignments of composite products  
1. Consignments of composite products  referred to by the HS codes 1601, 1602, 1603, 
1604, 1605, 1901, 1902, 1905, 2004, 2005, 2103, 2104, 2105, 2106  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 establishmen ts 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  4 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 into the 
Union , subject to c ompliance 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  to export each processed product of ani mal origin 
contained in the final product to the EU , pursuant to Commission Decision 
(EU) 2007/77725, Commission Regulation (EU) 605/201026, Commission 
Decision (EU) 2006/ 76627 and Commission Regulation (EU) 798/200828; 
(b) Composite products  referred to in paragraph 1  that do not need to be 
transported or stored under controlled temperatures containing any quantity of 
processed meat shall  originate from third countries or regions thereof 
authorised to export to the Union the meat products  contained in the composite 
product pursuant to  Commission Decision 2007/777/EC  and Decision 
2011/163 /EU29; 
(c) Composite products referred to in paragraph 1 that do not need to be 
transported or stored under controlled temperatures and contain processed 
                                                 
25 Commission Decision 2007/777/EC layin g down the animal and public health conditions and model 
certificates for imports of certain meat products and treated stomachs, bladders and intestines for human 
consumption from third countries and repealing Decision 2005/432/EC (OJ L 312, 30.11.2007, p.  49). 
26 Commission Regulation laying down animal and public health and veterinary certification conditions 
for the introduction into the European Union of raw milk and dairy products intended for human 
consumption  (O.J. L175, 10.7.2010. p . 1). 
27 Commission  Decision of 6 November 2006 establishing the lists of third countries and territories from 
which imports of bivalve molluscs, echinoderms, tunicates, marine gastropods and fishery products are 
permitted (OJ L 320, 18.11.2006, p. 53 –57). 
28 Commission Regul ation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, 
territories, zones or compartments from which poultry and poultry products may be imported into and 
transit through the Community and the veterinary certification requirements ( OJ L 226, 23.8.2008, 
p. 1). 
29 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) .  
EN 17  EN products o f animal origin other than 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 authorised to export meat products, 
dairy products, colostrum -based products , fishery products or egg products to 
the U nion on the basis of the EU animal and public health requirements  and 
which are listed at least for one of these products of animal origin  pursuant to 
Commission Decision (EU) 2007/777, Commission Regulation (EU) 605/2010, 
Commission Decision (EU) 2006/766 and Commission Regulation (EU) 
798/2008, and  in the annex to Decision 2011/163 on the basis of an approved 
residues control plan approved in accordance with  Directive 96/23/EC.   
Article  12 
Official certificates  
1. Each consignment of the following products shall enter the Union only where those 
consignments are accompan ied by an official certificate:  
(a) products of animal origin fo r whic h CN codes  have been laid down in Chapters 
Sections 2  to 5, 15, and 16, and HS codes  1506, 1521, 1601, 1602, 1603, 1604, 
1605,  2102, 2103, 2105, 2106, 2202, 2301, 2932, 3001, 3002, 3501, 3502, 
3503, 3504, 3507, 3913, 4101, 4102, 4103, 4110 and 9602  of Part II of Annex I 
to Council Regulation (EEC) No 2658/87, when these products a re intended for 
human consumption ; 
(b) live insects referred to by the CN codes 0106 49 00 ; 
(c) sprouts and seeds thereof intended for the production of sprouts and referred to 
by the following HS codes: 0704 90, 0706 90, 0708 10, 0708 20, 0708 90, 
0713 10 , 0713 33, 0712 34, 0712 35, 0713 39, 0713 40, 0712 50, 0712 60, 
0713 90, 0910 99, 1201 10, 1201 90, 1207 50, 1207 99, 1209 10 , 1209 
21, 1209 91 or 1214 90.  
2. 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 that are equivalent to those 
requirements;  
(b) any specific requirements  for entry into the Union set out  in this Regulation.  
3. The official certificates referred to in paragraph 1 may include details required in 
accordance with other Union legislation on public and animal health matters.  
4. The official certificate for sprouts and seeds intended for sprouting 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 . 
Article  13 
Privat e attestation  
1. A private attestation , prepared and signed by the impor ting food business operator , 
shall accompany the consignments of composite products as referred to in point 2 (c) 
of Article  11 confirming that the consignments comply with the relevant  
requirements referred to in Article  126(1) of Regulation (EU) 2017/625 .  
EN 18  EN 2. By way of derogation to paragraph 1, f or the products exempted from official 
controls at border control posts,  in accordance with  Article 48(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 account for the traceability of 
the consignment and sh all include information regarding the consigno r and 
consignee of the imported goods.  
4. The private attestation  referred to in paragraph 1 shall attest that:  
(a) the third country or region s thereof producing the composite product is 
authorised to export at least  one of the following category of produ ct of animal 
origin to the Union : 
(i) meat products;  
(ii) dairy products, colostrum -based products ; 
(iii) fishery products;  
(iv) egg products;  
(b) the establishment producing the composite products fulfils hygiene standards 
equivalent to those required by Regulation (EC) No 852/2004;  
(c) the product does not need  to be stored  or transported under controlled 
temperature;  
(d) the processed products of ani mal origin contained  in the composite product 
originate from third countries or regions thereof authorised  to export each 
processed product of animal origin to the U nion, or from the Union,  and are 
sourced from listed establishment(s) . The approval number of the 
establishment(s) shall be indicated  by the importing food business operator . 
The list of products of plant origin and processed products of animal origin 
contained in the composite products shall be indicated in descending order of 
weight, as record ed at the time of their use in the manufacture of the composite 
product ; 
(e) the processed products of animal origin used in the composite product have 
undergone at least the treatment provided for in the Union animal health import 
legislation for those products pursuant to Commission Decision (EU) 2007/777 
and Commission Regulation (EU) 605/2010  or a higher treatment  and a brief 
description must be provided of any processes undergone and temperatures 
applied to the product.  
Article  14 
Entry into force  
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 14  December 2019. However, the requirements laid down in Articles  11, 
(13)(1) and 13(2) shall  only apply from 21 April  2021.   
EN 19  EN This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER