EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10280/2018 CIS Rev. 2 
(POOL/G4/2018/10280/10280R2 -EN 
CIS.doc)  
[…](2018) XXX  draft  
 
Regulation (EU) 2017/625 (Official Control Regulation)  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
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 Regulation (EU) 2016/759 as regards these lists  
This draft has n ot 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 COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
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 Regulation (EU) 2016/759 as regards these lists  
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 
applicati on 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  127(2) thereof,  
After consulting the Standing  Committee on Plants, Animals, Food and Feed,  
Whereas:  
(1) Regulation (EU) 2017/625 lays down rules for official controls and other control 
activities performed by the competent authorities of the Member States in order to  
verify compliance with Union legislation in the area of, among others, food safety at 
all stages of the production, processing and distribution process. In particular, it 
provides that certain animals and goods are only to enter the Union from  of a third 
country or region thereof which appears on a list drawn up by the Commission for that 
purpose.  
(2) Commission Delegated Regulation (EU) [SANTE /10279/ 2018]2 supplements 
Regulation (EU) 2017/625 as regards the conditions for the entry in to the Union of 
consignments of certain animals and goods intended for human consumption from 
third countries and regions thereof in order to ensure that they comply with the 
relevant requirements established in the rules referred to in Article 1(2)(a) of 
Regulation (EU) 2017/625 (food safety) or with requirements recognised to be at least 
equivalent. Those conditions include the identification of the animals and goods 
intended for human consumption to which the requirement to come from a third 
country or reg ion thereof listed in accordance with Article 126(2)(a) of Regulation 
(EU) 2017/625 applies.  
                                                 
1 OJ L 95, 7.4.2017, p. 1.  
2 Commission Delegated Regulation (EU) …. of  ….. supplementing Regulation (EU) 2017/625 of the 
European Parliament and of the Council with regard to conditions to be respected by consignments of 
certain animals and good entering the Union (OJ L …., ../../.., p. ..).   
EN 2  EN (3) Lists of third countries and regions thereof for the entry in to the Union of 
consignments of certain animals and goods intended for human consumption  are 
establish ed to ensure compliance with food safety/ human health requirements in 
accordance with Article 11(1) of Regulation (EC) No  854/2004 of the European 
Parliament and of the Council3, which will be repealed by 14  December 2019, and 
with animal health requiremen ts in accordance with Article 8(1) of Council Directive 
2002/99/EC4. When compliance with both human and animal health requirements was 
deemed necessary , common lists covering both aspects were laid down.  
(4) Common  lists of third countries and regions thereo f for the entry in the Union of 
consignments of certain animals and goods intended for human consumption , are 
currently established  in: 
– Commission Implementing Regulation (EU) 2016/7595; 
– Commission Regulation (EU) No 206/20106; 
– Commission Regulation (EC) No 798/20087; 
– Commission Regulation (EC) No 119/20098; 
– Commission Decision 2007/777/EC9; 
– Commission Decision 2003/779/EC10; 
– Commission Regulation (EU) No 605/201011. 
                                                 
3 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).  
4 Council Directive 2002/99/EC  of 16  December 2002  laying down the animal health rules governing the 
production, processing, distribution and introduction of products of animal origin for human 
consumption  (OJ L 18, 23.1.2003, p. 11) . 
5 Commission Implementing Regulation (EU) 2016/759 of 28  April 2016 drawing up lists of third 
countries, parts of third countries and territories from which Member States are to authorise the 
introduction into the Union of certain products of animal origin intended for human consumption, 
laying down certificate requirements, amending Regulation (EC) No 2074/2005 and repealing Decision 
2003/812/EC (OJ L 126, 14.5.2016, p. 13).  
6 Commission Regulation (EU) No 206/2010 of 12  March 2010 laying down lists of third countries, 
territories or parts thereof authorised for  the introduction into the European Union of certain animals 
and fresh meat and the veterinary certification requirements (OJ L 73, 20.3.2010, p. 1).  
7 Commission Regulation (EC) No 798/2008 of 8  August 2008 laying down a list of third countries, 
territori es, 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). 
8 Commission Regulation (EC) No 119/2009 of 9  February 2009 laying down a list of third countries or 
parts thereof, for import into, or transit through, the Community of meat and wild leporidae, of certain 
wild land mammals and farmed rabbits and the veterinary certification requirements (OJ L 39, 
10.2.2009, p. 12) . 
9 Commission Decision 2007/777/EC of 29  November 2007 laying 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).  
10 Commission Decision 2003/779/EC of 31 October 2003 laying down animal health requirements and 
the veterinary certification for the import of animal casings from third countries (OJ L 285,  1.11.2003, 
p. 38).  
11 Commission Regulation (EU) No 605/2010 of 2  July 2010 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 consumpt ion (OJ L 175, 10.7.2010, p. 1).   
EN 3  EN (5) Additional lists of third countries and regions thereof authorising the  entry into the 
Union  of certain products  of animal origin  for public health reasons only, are 
established  in Commission Decision 2006/766/EC12, adopted under Article 11(1) of 
Regulation (EC) No 854/2004.  
(6) Since Regulation (EC) No 854/2004 is repealed by Regulation (EU) 2017/625  with 
effect from 14 December 2019  and in order to have one single legal act compiling all 
third countries and regions thereof , required to be listed to enter certain animals and 
goods on the Union market from human health perspective, it is appropriate to  
establish lists of those animals and goods  in this Regulation .  
(7) Lists should be  laid down in this Regulation  and delete d from  Implementing 
Regulation (EU) 2016/759  and Decision 2006/766/EC . Regulation (EU) 2016/759 
should therefore be amended accordingly  and Decision 2006/766/EC should be 
repealed . 
(8) Since discussion are ongoing on the requirements for listing of countries and regions 
thereof for entry of certain products of animal origin for animal health reasons, i t is 
also appropriate to provide lists fo r these products iun animal origin  by laying down  
cross -references to the existing lists for animal health reasons in order to avoid 
duplication of lists.  
(9) It is appropriate to maintain  common  lists for the purpose of Regulation (EU) 
2017/625 related to human health with the existing lists, laid down for animal health 
reasons and to keep a coordinated approach by only listing of third countries if a 
residue control programme has been approved in accordance with Council Directive 
96/23/EC13, when applicable.  
(10) Third countries and regions thereof were listed in the above acts based on the evidence 
and guarantees that were provided by the competent authorities of the third countries 
in accordance with Article 127(3) of Regulation (EU) 2017/625 and Article 4 of 
Dele gated Regulation (EU) [SANTE/10279/2018]  for goods and animals referred to in 
that Delegated Regulation. Re-assessment of compliance with these conditions is 
therefore not required.  
(11) Regulation (EC) No 853/2004 of the European Parliament and of the Council14 lays 
down requirements for food business operators importing any product of animal origin  
and composite products . In particular , it provides that food business operators 
importing any product  of animal origin from third countries or regions thereof are to  
ensure that the third country of dispatch appears on a list of third countries from which 
imports of such products are permitted . 
                                                 
12 Commission Decision 2006/766/EC 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 permi tted (OJ L 320, 18.11.2006, p. 53).  
13 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).  
14 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).   
EN 4  EN (12) Transitional measures providing for derogation s from the import conditions in 
Regulation (EC) No 853/2004 to certain products of animal origin are laid down in 
Commission Regulation (EU) 2017/18515, applying until 31 December 2020 .  
(13) Additional lists of third countries and regions thereof must therefore be established at 
the latest before those transitional meas ures expire to avoid an interruption of the entry 
into the Union  of consignments of those products of animal origin . Lists should be 
established  in particular for rendered animal fats and greaves, reptile meat, insects and 
casings.  
(14) Food consisting of, iso lated from or produced from insects or their parts  are subject to 
novel food authorisation in accordance with Regulation (EU) 2015/2283 of the 
European Parliament and of the Council16, while live insects are not. It is therefore 
appropriate to establish  separate lists  for these groups of products . 
(15) It is necessary to establish  before the end of the transitional measures  provided for in 
Regulation (EU) 2017/185 , a list of  products of animal origin other than those for 
which specific lists have been laid down in this Regulation to avoid jeopardi sing the 
entry in to the Union of currently imported products of animal origin , which are 
essential for European food business operators.  
(16) These transitional measures for certai n products of animal origin and composite 
products had been introduced because they represent a low risk for human health 
because of the very low quantities consumed or because the man ufacturing of the 
products largely excludes human health risk. It is therefore disproportionate to request 
all evidence and guarantees from third countries  in accordance with Article 127(3) of 
Regulation  (EU) 2017/625 and Article 4 of  Delegated Regulation (EU) 
[SANTE/10279/2018 ].  
(17) As Regulation (EU) 2017/625 applies with ef fect from 14 December 2019, this 
Regulation should also apply from that date.   
 
 
List of third countries and regions thereof allowed entry into the Union casing s for 
animal health reasons will only be established by 21 April 2021 in accordance with 
Regulat ion (EU) 2016/429 of the European Parliament and of the Council17. It is 
appropriate that the listing of  third countries and regions thereof allowed to entry  
casings into the Union  for human health reasons applies only from the same date on. 
Transitional me asures providing derogations concerning public health requirements 
for the entry into the Union of casings  should therefore be delayed until 20 April 202 1.  
(18) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing  Com mittee on Plants, Animals, Food and Feed,  
                                                 
15 Commission Regulation (E U) 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) . 
16 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 Counci l and 
Commission Regulation (EC) No 1852/2001 (OJ L 327 , 11.12.2015, p. 1).  
17 Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on 
transmissible animal diseases and amending and repealing certain acts in the area of ani mal health 
(Animal Health Law) (OJ L 84, 31.3.2016, p. 1).   
EN 5  EN HAS ADOPTED THIS REGULATION:  
Article  1 
Subject matter and s cope  
This Regulation establishes the lists of third countries or regions thereof from which  
consignments of  certain animals and goods intended for human co nsumption shall be 
authorised for entry  into the Union from food safety/ human health perspective in accordance 
with Article  126(2)(a) of Regulation (EU) 2017/625.  
Article  2 
Definitions  
For the purpose of this Regulation, the following definitions shall apply:  
(1) 'fresh meat' means fresh meat as defined in point 1.10 of Annex I to Regulation (EC) 
No 853/2004;  
(2) 'meat preparations' means meat preparations as defined in point 1.15 of Annex I to 
Regulation (EC) No 853/2004;  
(3) 'meat' means meat as defin ed in point 1.1 of Annex I to Regulation (EC) 
No 853/2004;  
(4) 'poultry' means poultry as defined in point 1.3 of Annex I to Regulation (EC) 
No 853/2004;  
(5) 'wild game' means wild game as defined in point 1.5 of Annex I to Regulation (EC) 
No 853/2004;  
(6) 'eggs' means eggs as defined in point 5.1 of Annex I to Regulation (EC) 
No 853/2004;  
(7) 'egg products' means egg products as defined in point 7.3 of Annex I to Regulation 
(EC) No 853/2004;  
(8) 'meat preparations' means meat preparations as defined in po int 1.15 of Annex I to 
Regulation (EC) No 853/2004;  
(9) 'meat products' means meat products as defined in point 7.1 of Annex I to Regulation 
(EC) No 853/2004;  
(10) 'treated stomachs, bladders and intestines' means treated stomachs, bladders and 
intestines as defined in point 7.9 of Annex I to Regulation (EC) No 853/2004;  
(11) 'bivalve molluscs' means bivalve molluscs as defined in point 2.1 of Annex I to 
Regulation (EC) No 853/2004;  
(12) 'fishery products' means fishery products as defined in point 3.1 of A nnex I to 
Regulation (EC) No 853/2004;  
(13) 'raw milk' means raw milk as defined in point 4.1 of Annex I to Regulation (EC) 
No 853/2004;  
(14) 'dairy products' means dairy products as defined in point 7.2. of Annex I to 
Regulation (EC) No 853/2004;  
(15) ‘colostrum’ means colostrum as defined in point 1 of Section IX of Annex III of 
Regulation (EC) No 853/2004;   
EN 6  EN (16) ‘colostrum -based products’ means colostrum -based products as defined in points 2 of 
Section IX of Annex III of Regulation (EC) No 853/2004;  
(17) 'frogs' legs' means frogs' legs as defined in point 6.1 of Annex I to Regulation (EC) 
No 853/2004;  
(18) 'snails' means snails as defined in point 6.2 of Annex I to Regulation (EC) 
No 853/2004;  
(19) 'rendered animal fat' means rendered animal fat defined in  point 7.5 of Annex I to 
Regulation (EC) No 853/2004;  
(20) 'greaves' means greaves as defined in point7.6 of Annex I to Regulation (EC) 
No 853/2004;  
(21) 'gelatine' means gelatine as defined in point 7.7 of Annex I to Regulation (EC) 
No 853/2004;  
(22) 'collagen' means collagen as defined in point 7.8 of Annex I to Regulation (EC) 
No 853/2004;  
(23) 'honey' means honey as defined in point 1 of Part IX of Annex II of Regulation (EC) 
No 1308/2013 of the European Parliament and of the Council18; 
(24) 'apicultur e products' means apiculture products as defined in point 2 of Part IX of 
Annex II of Regulation (EC) No 1308/2013;  
(25) 'reptile meat' means reptile meat as defined in point  (16) of Article 2 of Regulation 
(EU) [SANTE/10279/2018];  
(26) ‘insects’ means insects as defined in point (17) of Article 2  of Regulation (EU) 
[SANTE/10279/2018] . 
Article  3 
List of third countries or regions thereof authorised for the entry into the Union of fresh 
meat and meat preparations of ungulates  
Consignments of fresh meat and meat preparations of ungulates intended for human 
consumption shall only be authorised for the entry into the Union if they come from the third 
countries or regions thereof authorised for  the import  of such consignments  into the Union in 
accordance with point (a) of Article 14 of Regulation (EU) No 206/2010 . 
Article  4 
List of third countries or regions thereof authorised for the entry into the Union of meat 
of poultry, ratites and wild game birds, meat preparations of poultry, eggs and egg  
products  
Consignments of meat of poultry, ratites and wild game birds, meat preparations of poultry, 
eggs and egg products  intended for human consumption shall only be authorised for the entry 
into the Union if they come from the third countries or region s thereof authorised for  the 
import of such consignments into the Union in ac cordance with Article 3 of Regulation (EC) 
No 798/2008 . 
                                                 
18 Regulation (EC) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 
establishing a common organisation of the markets in agricultural products and repealing Council 
Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 
347, 20.12.2013, p. 671).   
EN 7  EN Article  5 
List of third countries or regions thereof authorised for the entry into the Union of meat 
of wild leporidae, of certain wild land mammals and of farmed rabbits  
Consignments of meat of wi ld leporidae, of certain wild land mammals and of farmed rabbits 
intended for human consumption shall only be authorised for the entry into the Union if they 
come from the third coun tries or regions thereof authorised for the import of such 
consignments into the Union in accordance with Article 3 of Regulation (EC) No 119/2009.  
Article  6 
List of third countries or regions thereof  authorised or the entry into the Union of meat 
products  and treated stomachs, bladders and intestines other than casings  
Consignm ents of  meat products and treated stomachs, bladders and intestines intended for 
human consumption shall only be authorised for the entry into the Union if they come from 
the third c ountries or regions thereof authorised for the import of such consignments into the 
Union in accordance with point (b) of Article 3 of Decision 2007/777/EC.  
However, c onsignments of biltong/jerky and pasteurised meat products intended for human 
consumption  shall only be authorised for the entry into the Union if they come from the third 
countries or regions thereof authorised for the import of such consignments into the Union in 
accordance with Part 3 of Annex II of Decision 2007/777/EC.  
Article  7 
Third countries or regions thereof authorised for the entry into the Union of casings  
Consignments of casings  intended for human consumption shall only be authorised for the 
entry into the Union if they come from the third countries or regions thereof autho rised for the 
import of such consignments into the U nion in accordance with Article 1 of Decision 
2003/779/EC .  
Article  8 
List of third countries or regions thereof  authorised  for the entry into the Union of live 
bivalve molluscs, echinoderms, tunicates an d marine gastropods  
Consignments of live bivalve molluscs, echinoderms, tunicates and marine gastropods 
intended for human consumption shall only be authorised for the entry into the Union if they 
come from third countries that are listed in Annex I of thi s Regulation.  
Article  9 
List of third countries or regions thereof authorised for the entry into the Union of 
fishery products  
Consignments of fishery products  intended for human consumption shall only be authorised 
for the entry into the Union if they come from third countries that are listed in Annex II of this 
Regulation .  
EN 8  EN Article  10 
List of third countries or regions thereof  authorised or the entry into the Union of 
consignments of raw milk, colostrum, dairy products and colostrum -based products   
Consignments of raw milk, colostrum, dairy products and colostrum -based products intended 
for human consumption shall only be authorised for the entry into the Union if they come 
from the third countries or regions thereof authorised for the import of such  consignments into 
the Union in accordance with Article 2 of  Regulation (EU) No 605/2010.  
Article  11 
List of third countries or regions thereof authorised for the entry into the Union of 
frogs’ legs  
Consignments of frogs' legs  intended for human consumptio n shall only be authorised for  the 
entry into the Union if they  come from third countries  or regions thereof  that are  listed in 
Annex II I of this Regulation . 
Article  12 
List of third countries or regions thereof authorised for the entry into the Union of 
snails, prepared in accordance with Section XI to Annex III of Regulation (EC) No 
853/2004  
Consignments of snails, prepared in accordance with Section XI of Annex III to Regulation 
(EC) No 853/2004 intended for human consumption shall only be authorised fo r the entry into 
the Union if they  come from third countries or regions thereof that are  listed in Annex I II to 
this Regulatio n. 
Article  13 
List of third countries or regions thereof authorised or the entry into the Union of 
rendered animal fats and greaves  
Consignments of rendered animal fats and greaves intended for human consumption shall 
only be authorised for the entry into the Union if they come from the third countries or 
regions thereof authorised for the import of meat products  into the Union  in accordance with 
point (b)(i) of Article 3 of Decision 2007/777/EC . 
Article  14 
List of third countries or regions thereof authorised for the entry into the Union of 
gelatine and collagen  
(a) Consignments of gelatine and collagen derived from bovine, ovine, caprine and 
porcine and equine animals, intended for human consumption shall only be 
authorised for the entry into the Union of such consignments if they come from the 
third countries or reg ions thereof authorised for  the import of consignments of fresh 
meat of the specific ungulates  into the Union in accordance with point (a) of Article 
14 of Regulation (EU) No 206/2010 , or from the Republic of South Korea , Malaysia, 
Pakistan or Taiwan . 
(b) Cons ignments of gelatine and collagen derived from poultry intended for human 
consumption shall only be authorised for the entry into the Union  of such 
consignments  if they come from the third countries listed in column 1 of Part 1 of 
Annex I to Regulation (EC ) No 798/2008  for which imports of fresh poultry meat of  
EN 9  EN the respective species are authorised as specified in that part of that Annex  or from 
Taiwan . 
(c) Consignments of gelatine and collagen derived from fishery products  intended for 
human consumption shall only be authorised for  the entry into the Union  of such 
consignments  if they come from the third countries and regions thereof that are listed 
in Annex II of this Regulation . 
(d) Consignments of gelatine and collagen deriv ed from leporidae and from wild land 
mammals not referred to in point (a)  of this Article , intended for human consumption 
shall only be authorised for the entry into the Union of such consignments if they 
come from the third countries listed  in column 1 of  Part 1 of Annex I to Regulation 
(EC)  No 119/2009 . 
Article  15 
List of third countries or regions thereof authorised for the entry into the Union of raw 
materials for the production of gelatine or collagen  
(a) Consignments of raw materials for the production of gelatine and collagen derived 
from bovine, ovine, caprine and porcine and equine animals intended for human 
consumption shall only be authorised for the entry into the Union of such 
consignments if they come from the thi rd countries or regions thereof authorised for 
the import of consignments of fresh meat of the specific ungulates into the Union in 
accordance with point (a) of Article 14 of Regulation (EU) No 206/2010 . 
(b) Consignments of raw materials for the production of gelatine and collagen derived 
from poultry intended for human consumption shall only be authorised for the entry 
into the Union of such consignments if they come from the third  countries listed in  
Part 1 of Annex I to Regulation (EC) No 798/2008  for which imports of fresh poultry 
meat of the respective species are authorised as specified in that part of that Annex .  
(c) Consignments of raw materials for the production of gelatine and collagen derived 
from fishery products intended for human consumption shall on ly be authorised for  
the entry into the Union of such consignments if they come from the third countries 
and regions thereof that are listed in Annex II of this Regulation.  
(d) Consignments of raw materials for the production of gelatine and collagen derived 
from leporidae and from wild land mammals not covered by  point (a)  of this Article , 
intended for human consumption shall only be authorised for the entry into the Union 
of such consignments if they come from the third countries listed in column 1 of Part 
1 of Annex I to Regulation (EC) No 119/2009.  
Article  16 
List of third countries or regions thereof  authorised  for the entry into the Union of 
treated raw materials for the production of gelatine or collagen  
(a) Consignments of treated raw materials for the production of gelatine and collagen 
derived from bovine, ovine, caprine and porcine and equine animals intended for 
human consumption shall only be authorised for the entry into the Union of such 
consignments if they come from the thi rd countries listed in column 1 of Part 1 of 
Annex II to Regulation (EU) No 206/2010 , or from the Republic of South Korea , 
Malaysia, Pakistan or Taiwan.   
EN 10  EN (b) Consignments of treated raw materials for the production of gelatine and collagen 
derived from poultry intended for human consumption shall only be authorised for 
the entry into the Union of such consignments if they come from the third countries 
listed in column 1 of Part 1 of A nnex I to Regulation (EC) No 798/2008 or from 
Taiwan.  
(c) Consignments of treated raw materials for the production of gelatine and collagen 
derived from fishery products intended for human consumption shall only be 
authorised for the entry into the Union of su ch consignments if they come from the 
third countries and regions thereof that are listed in Annex II of this Regulation .  
(d) Consignments of treated raw materials for the production of gelatine and collagen 
derived from leporidae and from wild land mammals n ot covered by  point (a), 
intended for human consumption shall only be authorised for the entry into the Union 
of such consignments if they come from the third countries listed in column 1 of Part 
1 of Annex I to Regulation (EC) No 119/2009.  
(e) Consignments of  treated raw materials for the production of gelatine and collagen 
referred to in point 4(b)(iii) of Chapter I in Section XIV of Annex III to Regulation 
(EC) No 853/2004,  shall only be authorised for the entry into the Union of such 
consignments if they co me from the third countries or region thereof authorised for 
the entry of raw materials derived from the same commodities in accordance with 
Article 15 of this Regulation.  
Article  17 
List of third countries or regions thereof authorised for the entry into  the Union of 
honey  and other apiculture products  
Consignments of honey and other apiculture products intended for human consumption shall 
only be authorised for  the entry into the Union if they come from the third countries listed in 
the ‘Country ’ column in the Annex to Commission Decision 2011/163/EU19 and marked with 
an ‘X’ in the ‘Honey’ column in that Annex . 
Article  18 
List of third countries or regions thereof authorised for the entry into the Union of 
certain highly refined products  
Consignments of highly refined chondroitin sulphate, hyaluronic acid, other hydrolysed 
cartilage products, chitosan, glucosamine, rennet, isinglass and amino acids intended for 
human consumption shall only be authorised for the entry into the Union if they  come from 
the following third countries or regions thereof : 
(a) in the case of raw materials derived from ungulates , third countries listed in column 1 
of Part 1 of Annex II to Regulation (EU) No  206/2010 , or from the Republic of 
South Korea, Malaysia, Pa kistan or Taiwan ; 
(b) in the case of raw materials derived from fishery products, all third countries  and 
regions thereof that are listed  in Annex II ; 
(c) in the case of raw materials derived from poultry, third countries and territories listed 
in column 1  of Part 1 of Annex I of Regulation (EC) No 798/2008.   
                                                 
19 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 11  EN Article  19 
List of third countries or regions thereof authorised for the entry into the Union of 
reptile meat  
Consignments of reptile meat intended  for human consumption shall only be authorised for 
the entry in to the Union if they come from Switzerland20, Botswana, Vietnam, South Africa or 
Zimbabwe.  
Article  20 
Third countries or regions thereof  authorised for the entry into the Union of food 
consisting of, isolated from or produced from insects or the ir parts  
Consignments of food consisting of, isolated from or produced from insects or their parts 
intend ed for human consumption shall  be authorised for the entry into the Union only if such 
foods are originated in and consigned from a third country or region thereof and are 
authorised in accordance with Regulation (EU) 2015/2283 of the European Parliament and of 
the Council and listed in the Union list of novel foods.  
Article 21  
List of third countries thereof authorised for the entry into the Union of live insects  
Consignments of live insects  intended for human consumption shall only be authorised for the 
entry into the Union if they come from third countries that are listed in Annex I V of this 
Regulation . 
Article  22 
List of third countries or regions t hereof authorised for the entry into the Union of othe r 
products of animal origin  
Consignments of products of animal origin other than those referred to in Articles 3 to 21  
intended for human consumption shall only be authorised for the entry into the Union if they 
come from the following thi rd countries or regions thereof : 
(a) if derived from ungulates , the third countries  listed in column 1 of Part 1 of Annex II 
to Regulation (EU) No  206/2010 , or from the Republic of South Korea, Malays ia, 
Pakistan or Taiwan ; 
(b) if derived from poultry, the third countries listed in the co lumn 1 of Part 1 of Annex I 
to Regulation (EC) No 798/2008  or from Taiwan;   
(c) if derived from fishery products, the third countries  or regions thereof that are listed 
in Annex II ; 
(d) if derived from leporidae and from wild land mammals not referred to in p oint (a) of 
this Article , the t hird countries listed in column 1 of Part 1 of Annex I to Regulation 
(EC) No 119/2009 ; 
(e) if derived from different species, the t hird countries and regions thereof listed in 
points  a) to d)  of this Article  for each product of animal origin.  
                                                 
20 In accordance with the Agreement between the European Community and the Swiss Confederation on 
trade in agricultural products .  
EN 12  EN Article  23 
Amendment to Implementing Regulation (EU) 2016/759  
Implementing Regulation (EU) 2016/759 is ame nded as follows:  
(1) Article 1 is deleted;  
(2) Annex I is deleted . 
Article  24 
Repeal  
Decision 2006/766/EC is repealed. References to Decision 2006/766/EC shall be construed as 
references to this Regulation.  
Article  26 
Transitional provisions  
Until 20 April  2021 , Member States shall  continue to allow the entry on their territory of 
casings  referred to in Article 7  from third countries or regions thereof.  
Article  25 
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.  
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