EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10224/2015 CIS Rev. 2 
(POOL/G4/2015/10224/10224R2 -EN 
CIS.doc)  
[…](2015) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
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 certificates requiremen ts, 
amending Regulation (EC) No 2074/2005 and repealing Decision 2003/812/EC  
(Text with EEA relevance)    
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
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 fo r human consumption, laying down certificates requirements, 
amending Regulation (EC) No 2074/2005 and repealing Decision 2003/812/EC  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the functioning of the European Union , 
Having regard to 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 consumption1 and in particular Article s 8(1) and 9(4) 
thereof,  
Having regard to 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 consumption2, and  in particular  
Article  11 (1) thereof , 
Whereas:  
(1) Regulation (EC) No 854/2004 requires products of animal origin to be imported only 
from a third country or a part of third country that appears on a list drawn up in 
accordance with that Regulation.  
(2) Commissi on Decision 2003/812/EC3 draws up lists of third countries from which 
Member States are to authorise imports of certain products for human consumption 
subject to Council Directive 92/118/EEC4. Those lists include a list of third countries 
or parts of third  countries from which  import s of gelatine  intended for human 
consumption are authorised . However, there is no list which covers  collagen , or raw 
materials for the production of gelatine and collagen , for human consumption.  It is 
appropriate to draw up such  lists. 
                                                 
1 OJ L 18, 23.1.2003, p. 11.  
2 OJ L 139, 30.4.2004, p. 206.  
3 Commission Decision 2003/812/EC of 17 November 2003 drawing up lists of third countries from 
which Member States  are to authorise imports of certain products for human consumption subject to 
Council Directive 92/118/EEC (OJ L 305, 22.11.2003, p. 17).  
4 Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health 
requirements governing  trade in and import into the Community of products not subject to the said 
requirements laid down in specific Community rules referred to in Annex A(I)  to Directive 
89/662/EEC, and, as regards pathogens, Directive 90/425/EEC ( OJ L 62, 15.3.1993, p. 49 ).  
EN 3   EN (3) In accordance with Regulation (EC) No 853/2004  of the European Parliament and of 
the Council5, food business operators importing products of animal origin are to 
ensure that the documents accompanying the consignment meet the requirements of 
Articl e 14 of Regulation (EC) No 854/2004. Commission Regulation (EC) 
No 2074/20056 lays down model certificates for imports of certain products of animal 
origin intended for human consumption. Those  model certificates include outdated 
references to previous leg islation that need  to be updated.  
(4) Third countries , parts of third countries and territories listed in Annex II to 
Commission Decision 2006/766/EC7, in Part 1 of Annex I to Commission Regulation 
(EC) No 798/20088, in Part  1 of Annex I to Commission Regulati on (EC) 
No 119/20099 or in Part 1 of Annex II to Commission Regulation (EU) No 206/201010 
meet the Union requirements with regard to imports of fresh meat  and certain fishery 
products . Those lists could also be used for  import s of raw material s for the prod uction 
of gelatine and collagen . However, less strict requirements should apply if those raw 
materials have been subjected to certain treatments as  provided for in Sections XIV 
and XV of Annex III to Regulation (EC) No 853/2004 . 
(5) Raw material s for the produ ction of gelatine and collagen, whether or not treated, 
introduced into the Union for transit to a third country , pose a negligible risk to public 
health. Such raw materials, even when  treated , should, however, comply with the 
relevant animal health requir ements. Accordingly, a list of third countries, parts of 
third countries or territories  should be drawn up and model certificate s for transit, and 
storage before  transit, of raw  materials  and treated raw material s for the production of 
gelatine and collage n should be laid down.  
(6) Due to the geographical situation of Kaliningrad , specific animal health conditions 
should be laid down for transit via the Union of consignments of raw material s and 
treated raw materials for the production of gelatine  or collagen  to and from Russia, 
which only concern transit through Latvia, Lithuania and Poland . 
(7) In the interest of clarity and simplification of Union legislation, the lists of third 
countries, parts of third countries and territories from which Member States are to 
                                                 
5 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 ). 
6 Commission Regulation (EC) No 2074/2005 of 5 December 2005 laying down implementing measures 
for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council 
and for the organisation of official controls under Regulation (EC) No 854/2004 of the European 
Parliament and of the Council and Reg ulation (EC) No 882/2004 of the European Parliament and of the 
Council , derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council 
and amending  Regulation s (EC) No 853/2004 and (EC) No  854/2004 ( OJ L 338, 22.12.2005, p. 27 ). 
7 Commission Decision 2006/766/EC of 6 November 2006 establishing the lists of third countries and 
territories from which import s of bivalve molluscs, echinoderms, tunicates, marine gastropods and 
fishery products are permitted (OJ L 320, 18.11.2006, p. 53 ). 
8 Commission Regulation (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 certifi cation requirements (OJ L 226,23.8.2008,  p. 1).  
9 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. 1 2). 
10 Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countries, 
territories or parts thereof authorised for the in troduction into  the European Union of certain animals 
and fresh meat and the veterinary certification requirements (OJ L 73, 20.3.2010, p. 1).   
EN 4   EN authorise  the introduc tion of frogs' legs, snails, gelatine, collagen, raw material s and 
treated raw materials for the production of gelatine  and collagen , and honey, royal 
jelly and other products of apiculture for human consumption , and the model 
certific ates for th ose products , should be set out in an Annex to this Regulation . 
Consequently , the corresponding existing certificates should  be deleted  from Annex 
VI to Regulation (EC) No 2074/2005 . 
(8) In order to ensure the safety of  certain highly refined produc ts of animal origin , 
specific requirements  have been inserted in Annex III to Regulation (EC) 
No 853/2004 . Therefore it is appropriate to draw up  the list of countries from which 
those products may be imported and lay down  a model certificate for th ose pro ducts .  
(9) As the lists of third countries, parts of third countries and territories  from which 
Member States are to  authorise imports of furred farm game meat products and 
feathered farm game meat products and leporidae (rabbit and hare) meat and their 
meat products  have been laid down in Commission Decision 2007/777/EC11 and in 
Regulation (EC) No 119/2009  respectively , Decision 2003/812/EC becomes redundant 
and should be repealed.  
(10) It is appropriate to introduce a transitional period to allow Member States and  food 
business operators to adapt to the new  requirements laid down in this Regulation .  
(11) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATIO N: 
CHAPTER 1 
IMPORTS OF CERTAIN PRODUCTS OF ANIMAL ORIGIN  
Article 1 
Lists of third countries, parts of third countries and territories  
The third countries, parts of third countries and territories from which Member States are to  
authorise the import of the following products of animal origin intended for human 
consumption  are set out in the relevant Parts of Annex I : 
(a) frogs' legs , Part I ; 
(b) snails , Part II ; 
(c) gelatine and c ollagen , Part III ; 
(d) raw material s for the production of gelatine and collag en, Part IV ; 
(e) treated raw material s for the production of gelatine and collagen , Part V ; 
(f) honey , royal jelly and other products of apiculture , Part VI ; 
(g) the following highly refined products, Part VII:  
(i) chondroitin sulphate,  
                                                 
11 Commission Decision 2007/777/EC of 29 November 2007 laying down the animal and public health 
conditions and mod el certificates for import s 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 ).  
EN 5   EN (ii) hyaluronic ac id, 
(iii) other  hydrolysed cartilage  products,  
(iv) chitosan,  
(v) glucosamine,  
(vi) rennet,  
(vii) isinglass,  
(viii)  amino acids that are authorised as food additives in accordance with 
Commission Regulation (EU) No 1333/2008.  
Article 2 
Model certifica tes  
1. The model certificates for imports into the Union of the products referred to in 
Article  1 are set out in Annex II as follows:   
(a) frogs' legs , Part I ; 
(b) snails, Part II;  
(c) gelatine, Part III;  
(d) collagen, Part IV;  
(e) raw material s for the p roduction of gelatine and collagen , Part V ; 
(f) treated raw material s for the production of gelatine and collagen , Part V I; 
(g) honey , royal jelly and other products of apiculture , Part V II; 
(h) the following highly refined products, Part VIII  
(i) chondroi tin sulphate,  
(ii) hyaluronic acid , 
(iii) other hydrolysed cartilage products,  
(iv) chitosan,  
(v) glucosamine,  
(vi) rennet,  
(vii) isinglass,  
(viii)  amino acids that are authorised as food additives in accordance with 
Commission Regulation (EU) No 133 3/2008 . 
Those certificates must be completed in accordance with the explanatory  notes  set 
out in Annex IV and the notes in the relevant certificate.  
2. Electronic certification and other systems agreed between the Union and the third 
country concerned may be used.    
EN 6   EN CHAPTER 2 
TRANSIT OF CERTAIN PRODUCTS OF ANIMAL ORIGIN  
Article 3 
Lists of third countries, parts of third countries and territories   
The third countries, parts of third countries and territories from which Member States are to  
authorise the tran sit through the Union of raw materials and treated raw material s for the 
production of gelatine and collagen intended for human consumption bound  for a third 
country, either by immediate transit or after storage in the Union in accordance with Article 
12(4) and Article 13 of Council Directive 97/78/EC12, are set out in Part s IV and V of Annex I 
to this Regulation , respectively .  
Article 4 
Model certificate  
1. The model certificate for the transit through the Union of the raw materials and 
treated raw materi als referred to in Article 3  is set out in Annex II I. 
That certificate  must be completed in accordance with the notes set out in Annex IV 
and in the relevant model certificate.  
2. Electronic certification and other systems harmonised at Union level may be  used.   
Article 5 
Derogation for transit through Latvia, Lithuania and Poland  
1. By way of derogation from Article 3, transit by road or by rail between the specific  
designated border inspection posts in Latvia, Lithuania and Poland , listed and 
marked with  special remark 13 in Annex I to Commission Decision 2009/821/EC13, 
of consignments of the raw materials or treated raw materials referred to in Article 3 
of this Regulation coming from and bound for Russia, directly or via another third 
country, shall be a uthorised where the following conditions are met:  
(a) the consignment is sealed with a serially numbered seal by the official 
veterinarian at the border inspection post of entry;  
(b) the documents accompanying the consignment, as provided for in Article 7 of 
Directive 97/78/EC, are stamped with the words “Only for transit to Russia via 
the EU” on each page by the official veterinarian at the border inspection post 
of entry;  
(c) the procedural requirements provided for in Article 11 of Directive 97/78/EC 
are complied with;  
(d) the consignment is certified as acceptable for transit on the common veterinary 
entry document issued by the official veterinarian at the border inspection post 
of entry.  
                                                 
12 Council Directive 97/78/EC of 18 December 1997  laying down the principles governing the 
organisation of veterinary checks on products entering the Community from third countries  (OJ L 24, 
30.1.1998, p. 9).  
13 Commission Decision 2009/821/EC of 28 September 2009 drawing up a list of approved border 
inspection post s, laying down certain rules on the inspections carried out by Commission veterinary 
experts and laying down the veterinary units in Traces ( OJ L 296, 12.11.2009, p. 1 ).  
EN 7   EN 2. The consignments referred to in paragraph 1 shall not be unloa ded or put into 
storage , as referred to in Article 12(4) or in Article 13 of Directive 97/78/EC, within  
the U nion. 
3. Regular audits shall be conducted by the competent authority to ensure that the 
number of consignments referred to in paragraph 1 and the corresponding quantities 
of products leaving the Union correspond with the number and quantities which have 
been introduced in the U nion. 
CHAPTER 3 
FINAL PROVISIONS  
Article 6 
Amendment  
Annex VI to Regulation ( EC) No 2 074/2005  is amended as follows:  
(1) in Section I, Chapters I, II, III and VI are deleted;  
(2) Appendices I, II, III and VI are deleted.  
Article 7 
Repeal  
Decision 2003/812/EC is repealed.  
Article 8 
Transitional provisions  
Consignments of products of animal origin  in respect of which the releva nt model certificates 
have been issued in accordance with Regulation (EC) No 2074/2005 may continue to be 
introduced into the Union provided that the certificate was signed before XX/XX/2016 
[6 months after the date of entry into force of this Regulation] . 
Article 9 
Entry into force  
This Regulation shall enter into force on the twentie th day following that of its publication in 
the Official Journal of the European Union . 
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