REGUL ATIONS 
COMMI SSION IMPLEMENTING REGUL ATION (EU) 2017/731 
of 25 Apr il 2017 
amending model veter inar y certificates BOV-X, BOV-Y, BOV and OVI set out in Annex es I and II 
to Regulation (EU) No 206/2010, the model certificates GEL, COL, RCG and TCG set out in 
Annex II to Implementing Regulation (EU) 2016/759 and the model certificate for composite 
products set out in Annex I to Regulation (EU) No 28/2012 in relation to the rules for the 
prev ention, control and eradication of certain transmissible spongif orm encephalopathies 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d 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, distr ibution and introduction of products of animal origin for human consum ption (1), and 
in particular Article 9(2)(b) and 9(4)(b) thereof, 
Having regard to Council Directive 2004/68/EC of 26 Apr il 2004 laying down animal health rules for the importation 
into and transit through the Community of certain live ungulate animals, amending Directives 90/426/EEC and 
92/65/EEC and repealing Directive 72/462/EEC (2), and in particular Article 13(1)(e) thereof, 
Having regar d to Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 Apr il 2004 laying 
down specific rules for the organisation of official controls on products of animal origin intende d for human 
consum ption (3), and in particular the second paragraph of Article 16 thereof, 
Whereas: 
(1)  Commission Regulation (EU) No 206/2010 (4) lays down, inter alia, the veterinar y certification requirements for 
the introduction into the Union of certain consignments of live animals including domestic bovine animals and 
consignments of fresh meat intended for human consump tion, including fresh meat of domestic bovine, ovine 
and capr ine animals. 
(2)  Part 2 of Annex I to Regulation (EU) No 206/2010 sets out a model of veterinar y certificate for domestic bovine 
animals (including Bubalus and Bison species and their cross-breeds) intended for breeding and/or production after 
importation (BOV-X) and a model of veter inar y certificate for domestic bovine animals (including Bubalus and 
Bison species and their cross-breeds) intended for immediate slaughter after importation (BOV-Y). Part 2 of 
Annex II to that Regulation sets out a model of veteri nary certificate for fresh meat, including minced meat, of 
domestic bovine animals (including Bubalus and Bison species and their cross-breeds) (BOV) and a model of 
veterinar y certificate for fresh meat, including minced meat, of domestic ovine animals (Ovis aries) and domestic 
capr ine animals (Capr a hircus) (OVI). Those models of veteri nary certificates include guarant ees for bovine 
spongif orm encephalopath y (BSE). 
(3)  Commission Implementing Regulation (EU) 2016/759 (5) lays down, inter alia, the vete rinar y certificat ion 
requirements for the introduction into the Union of certain products of animal origin intende d for human 
consum ption. 26.4.2017 L 108/7 Official Jour nal of the European Union EN     
(1)OJ L 18, 23.1.2003, p. 11. 
(2)OJ L 139, 30.4.2004, p. 320. 
(3)OJ L 139, 30.4.2004, p. 206. 
(4)Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countr ies, territories or parts thereof author ised 
for the introduction into the European Union of certain animals and fresh meat and the veterin ary certification requirements (OJ L 73, 
20.3.2010, p. 1). 
(5)Commission Implementing Regulation (EU) 2016/759 of 28 Apr il 2016 drawing up lists of third countr ies, parts of third countr ies and 
territories from whic h Member States are to author ise the introduction into the Union of certain products of animal origin inten ded for 
human consump tion, laying down certificate requirements, amending Regulation (EC) No 2074/2005 and repealing Decision 
2003/812/EC (OJ L 126, 14.5.2016, p. 13). (4)  Annex II to Implementing Regulation (EU) 2016/759 sets out a model certificate for impor ts of gelatine intended 
for human consum ption (GEL) in Part III thereof, a model certificate for imports of collagen intended for human 
consum ption (COL) in Part IV thereof, a model for imports of the raw mat erials for the production of gelat ine 
and collagen intended for human consump tion (RCG) in Part V thereof, and a model certificate for impor ts of 
the treated raw mater ials for the production of gelatine and collagen intended for human consump tion (TCG) in 
Part VI. Those models of vete rinar y certificates include guarant ees for BSE for products of bovine, ovine and 
capr ine origin. 
(5)  Commission Regulation (EU) No 28/2012 (1) lays down, inter alia, the health certification requirements for 
imports into or transit through the Union of consignments of certain composit e products intended for human 
consum ption. 
(6)  Annex I to Regulation (EU) No 28/2012 sets out the model of health certificate for impor ts into the European 
Union of composit e products intended for human consump tion. That model of health certificate includes 
guarant ees for BSE for products of bovine, ovine and capr ine origin. 
(7)  Regulation (EC) No 999/2001 of the European Parliament and of the Council (2) lays down rules for the 
prevention, control and eradication of transmissible spongif orm encephalopathies (TSEs) in bovine, ovine and 
capr ine animals. Chapt er B of Annex IX to Regulation (EC) No 999/2001 lays down the conditions for impor t 
into the Union of bovine animals as regar ds BSE and Chapt er C of that Annex lays down the conditions for 
import into the Union of products of animal origin for human consump tion from bovine, ovine and capr ine 
animals as rega rds BSE. 
(8)  Regulation (EC) No 999/2001 was amended by Commission Regulation (EU) 2016/1396 (3). Those amendments 
provide, inter alia, for clarification of the rules laid down in Chapt er B and Chapt er C of Annex IX to Regulation 
(EC) No 999/2001. They also provide for the amendment of the requirement to indicate a blue stripe on the 
label of the carcasses or wholesale cuts of the carcasses of bovine animals when remo val of the vertebr al column 
is not required as set out in Chapt er C of Annex IX to that Regulation. This amendment requires that a red stripe 
should be indicated instead on the label when such remo val is required for products of bovine animal origin 
imported into the Union. 
(9)  In particular Regulation (EC) No 999/2001, as amended by Regulation (EU) 2016/1396, permits the imports of 
products of animal origin for human consum ption of bovine, ovine and capr ine animal origin from third 
countr ies with a negligible BSE risk as laid down in Section B of Chapt er C of Annex IX, also where those 
products are derived from raw mate rial coming from countr ies with a controlled or an undete rmined BSE risk, 
provided that specified risk mater ial has been remo ved from such raw mater ial. 
(10)  The model veteri nary certificates BOV-X and BOV-Y set out in Part 2 of Annex I and BOV and OVI set out in 
Part 2 of Annex II to Regulation (EU) No 206/2010, the model veter inar y certificates GEL, COL, RCG and TCG 
set out in Annex II to Implementing Regulation (EU) 2016/759 and the model health certificate for impor t into 
the Union of compo site products set out in Annex I to Regulation (EU) No 28/2012 should theref ore be 
amended in order to reflect the requirements relating to imports of bovine animals and of fresh meat of bovine, 
ovine and capr ine animals and of products of animal origin for human consum ption of bovine, ovine and 
capr ine animal origin, laid down in Regulation (EC) No 999/2001, as amended by Regulation (EU) 2016/1396. 
(11)  Regulation (EU) No 206/2010, Implementing Regulation (EU) 2016/759 and Regulation (EU) No 28/2012 
should theref ore be amended according ly. 
(12)  Regulation (EU) 2016/1396 provides that the amendments that it made to Annex IX to Regulation (EC) 
No 999/2001 are to apply from 1 July 2017. 26.4.2017 L 108/8 Official Jour nal of the European Union EN     
(1)Commission Regulation (EU) No 28/2012 of 11 Januar y 2012 laying down requirements for the certification for impor ts into and 
transit through the Union of certain composit e products and amending Decision 2007/275/EC and Regulation (EC) No 1162/2009 
(OJ L 12, 14.1.2012, p. 1). 
(2)Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, 
control and eradication of certain transmissible spongif orm encephalopathies (OJ L 147, 31.5.2001, p. 1). 
(3)Commission Regulation (EU) 2016/1396 of 18 Aug ust 2016 amending certain Annexes to Regulation (EC) No 999/2001 of the 
European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible 
spongif orm encephalopathies (OJ L 225, 19.8.2016, p. 76). (13)  In order to avoid any disrupti on of imports into the Union of consignments of live bovine, ovine and capr ine 
animals, of fresh meat of domestic bovine, ovine and capr ine animals, of gelatine, collagen , raw mate rials for 
production of gelatine and collagen and treated raw mat erials for the production of gelatine and collage n 
intende d for human consump tion and of certain composit e products intended for human consump tion, the use 
of certificates issued in accordance with Regulation (EU) No 206/2010, Implementing Regulation (EU) 2016/759 
and Regulation (EU) No 28/2012 as applicable prior to the amendments being introduced by this Regulation 
should continue to be author ised during a transitional period subject to certain conditions. 
(14)  The measures provided for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
Annex es I and II to Regulation (EU) No 206/2010 are amended in accordance with Annex I to this Regulation. 
Article 2 
Annex II to Implementing Regulation (EU) 2016/759 is amended in accordance with Annex II to this Regulation. 
Article 3 
Annex I to Regulation (EU) No 28/2012 is amended in accordance with Annex III to this Regulation. 
Article 4 
1. For a transitional period until 31 December 2017, consignments of live bovine, ovine and capr ine animals, 
accompan ied by a model certificate issued in accordance with the model set out in Part 2 of Annex I to Regulation (EU) 
No 206/2010 and consignments of fresh meat of domestic bovine, ovine and capr ine animals, accompanied by a model 
certificate issued in accordance with the model set out in Part 2 of Annex II to Regulation (EU) No 206/2010, as 
applicable before the amendments made by this Regulation, shall continue to be author ised for importation into the 
Union provided that the certificate was issued no later than 30 November 2017. 
2. For a transitional period until 31 December 2017, consignments of gelat ine intende d for human consum ption, 
collagen intende d for human consump tion, raw mate rials for production of gelatine and collage n intended for human 
consum ption and treated raw mater ials for the production of gelatine and collagen intende d for human consum ption, 
accompan ied by a model certificate issued in accordance with the model set out respectively in Parts III, IV, V and VI of 
Annex II to Implementing Regulation (EU) 2016/759, as applicable before the amendments made by this Regulation, 
shall continue to be author ised for importation into the Union provided that the certificate was issued no later than 
30 November 2017. 
3. For a transitional period until 31 December 2017, consignments of certain compo site products intended for 
human consum ption, accompanied by a model certificate issued in accordance with the model set out in Annex I to 
Regulation (EU) No 28/2012, as applicable before the amendments made by this Regulation, shall continue to be 
author ised for importation into the Union provided that the certificate was issued no later than 30 November 2017. 
Article 5 
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 1 July 2017. 26.4.2017 L 108/9 Official Jour nal of the European Union EN     This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 25 Apr il 2017. 
For the Commission 
The Presid ent 
Jean-Claude JUNCKER  26.4.2017 L 108/10 Official Jour nal of the European Union EN     ANNEX I 
Annex es I and II to Regulation (EU) No 206/2010 are amended as follows:  
(1) In Annex I, Part 2 is amended as follows: 
(a)  The model veteri nary certificate BOV-X is amended as follows: 
(i)  In Part II.1, Public Health Attestation, point II.1.3 is replaced by the following: 
‘II.1.3.  with rega rd to bovine spongif orm encephalopathy (BSE):  
(a) the animals are identif ied by a permanent identif ication system enabling them to be traced 
back to the dam and herd of origin, and they have not been exposed to the following 
animals: 
(i)  any BSE cases; 
(ii)  bovine animals whic h, during their first year of life, were reared with the BSE cases 
during their first year of life, and which investig ation has shown consumed the same 
pote ntially contaminated feed during that period; or 
(iii)  if the results of the investigation referred to in indent (ii) are inconclusive, bovine 
animals born in the same herd as, and within 12 months of the birth of, the BSE cases;  
(1) (2) either [(b) if there have been BSE indigenous cases in the countr y concer ned, the animals were born 
after the date from which the ban on the feeding of ruminants with meat-and-bone meal and 
greav es derived from ruminants, as defined in the Terrestr ial Animal Health Code of the 
World Org anisation for Animal Health, was effectively enforced or after the date of birth of 
the last BSE indig enous case if born after the date of the feed ban.]  
(1) (3) or [(b) the animals were born after the date from which the ban on the feeding of ruminants with 
meat-and-bone meal and greaves derived from ruminants as defined in the Terrestr ial Animal 
Health Code of the World Organisation for Animal Health, was effectively enforced or after 
the date of birth of the last BSE indigenous case if born after the date of the feed ban.]  
(1) (4) or [(b) the animals were born at least two years after the date from whic h the ban on the feeding of 
ruminants with meat-and-bone meal and greaves derived from ruminants, as defined in the 
Terrestr ial Animal Health Code of the World Org anisation for Animal Health, was effectively 
enforced or after the date of birth of the last BSE indigenous case if born after the date of the 
feed ban.]’ 
(ii)  In Part II of the Notes, the footnote s (2), (3) and (4) are replaced by the following: 
‘(2)  Only if the animals were born and continuously reared in a countr y or region or countr ies or regions 
classified in accordance with Decision 2007/453/EC as countr ies or regions posing a negligible BSE risk. 
(3)  Only if the countr y or region of origin is classified in accordance with Decision 2007/453/EC as 
a countr y or region posing a controlled BSE risk. 
(4)  Only if the countr y or region of origin has been classifie d in accordance with Decision 2007/453/EC as 
a countr y or region posing an undetermined BSE risk.’ 
(b)  The model veteri nary certificate BOV-Y is amended as follows: 
(i)  In Part II.1, Public Health Attestation, point II.1.3 is replaced by the following: 
‘II.1.3.  with rega rd to bovine spongif orm encephalopathy (BSE):  
(a) the animals are identif ied by a permanent identif ication system enabling them to be traced 
back to the dam and herd of origin, and have not been exposed to the following animals: 
(i)  any BSE cases; 26.4.2017 L 108/11 Official Jour nal of the European Union EN     (ii)  bovine animals whic h, during their first year of life, were reared with the BSE cases 
during their first year of life, and which investig ation has shown consumed the same 
pote ntially contaminated feed during that period; or 
(iii)  if the results of the investigation referred to in indent (ii) are inconclusive, bovine 
animals born in the same herd as, and within 12 months of the birth of, the BSE cases;  
(1) (2) either [(b) if there have been BSE indigenous cases in the countr y concer ned, the animals were born 
after the date from which the ban on the feeding of ruminants with meat-and-bone meal and 
greav es derived from ruminants, as defined in the Terrestr ial Animal Health Code of the 
World Org anisation for Animal Health, was effectively enforced or after the date of birth of 
the last BSE indig enous case if born after the date of the feed ban.]  
(1) (3) or [(b) the animals were born after the date from which the ban on the feeding of ruminants with 
meat-and-bone meal and greaves derived from ruminants as defined in the Terrestr ial Animal 
Health Code of the World Organisation for Animal Health, was effectively enforced or after 
the date of birth of the last BSE indigenous case if born after the date of the feed ban.]  
(1) (4) or [(b) the animals were born at least two years after the date from whic h the ban on the feeding of 
ruminants with meat-and-bone meal and greaves derived from ruminants, as defined in the 
Terrestr ial Animal Health Code of the World Org anisation for Animal Health, was effectively 
enforced or after the date of birth of the last BSE indigenous case if born after the date of the 
feed ban.]’ 
(ii)  In Part II of the Notes, footnot es (2), (3) and (4) are replaced by the following: 
‘(2)  Only if the animals were born and continuously reared in a countr y or region or countr ies or regions 
classified in accordance with Decision 2007/453/EC as countr ies or regions posing a negligible BSE risk. 
(3)  Only if the countr y or region of origin is classified in accordance with Decision 2007/453/EC as 
a countr y or region posing a controlled BSE risk. 
(4)  Only if the countr y or region of origin has been classifie d in accordance with Decision 2007/453/EC as 
a countr y or region posing an undetermined BSE risk.’  
(2) Annex II, Part 2 is amended as follows: 
(a)  The model veteri nary certificate BOV is amended as follows: 
(i)  In Part II.1, Public Health Attestation, point II.1.9 is replaced by the following:  
‘(1) either  [II.1.9. with regard to bovine spongif orm encephalopathy (BSE):  
(a) the countr y or region of dispatch is classified in accordance with Decision 
2007/453/EC as a countr y or region posing a negligible BSE risk;  
(1) either [(b) the animals, from which the meat or minced meat was derived: 
(i)  were born, continuously reared and slaughter ed in a countr y or region 
classif ied in accordance with Decision 2007/453/EC as a countr y or region 
posing a negligible BSE risk; 
(ii)  were slaughtere d after stunning by means of gas injected into the cranial 
cavity or killed by the same method or slaughter ed by laceration after 
stunning of central nervous tissue by means of an elongat ed rod-shaped 
instr ument introduced into the cranial cavity; ]  
(1) or [(b) the animals, from which the meat or minced meat was derived, were not 
slaughtere d after stunning by means of gas injecte d into the cranial cavity or 
killed by the same method or slaughtere d by laceration after stunning of central 
nervous tissue by means of an elongat ed rod-shaped instr ument introduced into 
the cranial cavity;]  
(1) either [(c) the meat or minced meat does not contain and is not derived from specifi ed risk 
mater ial as defined in point 1 of Annex V to Regulation (EC) No 999/2001 (*);] 26.4.2017 L 108/12 Official Jour nal of the European Union EN     (1) or [(c) (i)  the meat or minced meat is derived from animals whic h originat e from 
a countr y or region classified in accordance with Decision 2007/453/EC as 
a countr y or region posing a controlled or an undete rmined BSE risk; 
(ii)  the carcasses, half carcasses or half carcasses cut into no more than three 
wholesale cuts, and quar ters contain no specified risk mater ial other than the 
vertebr al column, including dorsal root gang lia; 
(iii)  the carcasses or wholesale cuts of carcasses of animals aged over 30 months 
and containing vertebral column are identif ied by a clearly visible red stripe 
on the label refer red to in Article 13 or 15 of Regulation (EC) 
No 1760/2000 (3);]  
(1) either [(d) the meat or minced meat is derived from mechanically separated meat, obtained 
from bones of bovine animals whic h were born, continuously reared and 
slaughtere d in a countr y or region classified in accordance with Decision 
2007/453/EC as a countr y or region posing a negligible BSE risk and in whic h 
there have been no BSE indig enous cases;]  
(1) or [(d) the meat or minced meat is not derived from mechanically separated meat, 
obtained from bones of bovine animals;]  
(1) [(e) (i)  the animals, from which the meat or minced meat is derived, originate from 
a countr y or region classified in accordance with Decision 2007/453/EC as 
a countr y or region posing an undetermined BSE risk; 
(ii)  the animals, from whic h the meat or minced meat is derived, have not been 
fed with meat-and-bone meal or greav es, as defined in the Terrestr ial Animal 
Health Code of the World Org anisation for Animal Health; 
(iii)  the meat or minced meat was produced and handled in a manner which 
ensures that it did not contain and was not contaminated with nervous and 
lymphatic tissues exposed during the deboning process.]]  
(1) or  [II.1.9. with regard to bovine spongif orm encephalopathy (BSE):  
(a) the countr y or region of dispatch is classif ied in accordance with Decision 
2007/453/EC as a countr y or region posing a controlled BSE risk;  
(b) the animals from which the bovine meat or minced meat is derived were not 
been killed after stunning by laceration of central nervous tissue by means of an 
elongat ed rod-shaped instr ument introduced into the cranial cavity , or by means 
of gas injecte d into the cranial cavity;  
(1) either [(c) the meat or minced meat does not contain and is not derived from specifi ed risk 
mater ial as defined in point 1 of Annex V to Regulation (EC) No 999/2001, or 
mechanically separated meat obtained from bones of bovine animals.]  
(1) or [(c) the carcasses, half carcasses or half carcasses cut into no more than three 
wholesale cuts, and quar ters contain no specified risk mater ial other than the 
vertebral column, including dorsal root ganglia. The carcasses or wholesale cuts of 
carcasses of animals aged over 30 months and containing vertebral column are 
identif ied by a clearly visible red stripe on the label refer red to in Article 13 or 15 
of Regulation (EC) No 1760/2000 (3).]]  
(1) or  [II.1.9. with regard to bovine spongif orm encephalopathy (BSE):  
(a) the countr y or region of dispatch has not been classified in accordance with 
Decision 2007/453/EC or is classified as a countr y or region with an 
undete rmined BSE risk; 26.4.2017 L 108/13 Official Jour nal of the European Union EN     (b) the animals from whic h the meat or minced meat is derived were not fed meat- 
and-bone meal or greav es derived from ruminants, as defined in the Terrestr ial 
Animal Health Code of the World Org anisation for Animal Health;  
(c) the animals from which the meat or minced meat is derived were not killed, after 
stunning, by laceration of central nervous tissue by means of an elongat ed rod- 
shaped instr ument introduced into the cranial cavity , or by means of gas injected 
into the cranial cavity;  
(1) either [(d) the meat or minced meat does not contain and is not derived from: 
(i)  specified risk mater ial as defined in point 1 of Annex V to Regulation (EC) 
No 999/2001; 
(ii)  nervous and lymphatic tissues exposed during the deboning process; 
(iii)  mec hanically separated meat obtained from bones of bovine animals.]  
(1) or [(d) the carcasses, half carcasses or half carcasses cut into no more than three 
wholesale cuts, and quar ters contain no specified risk mater ial other than the 
vertebr al column, including dorsal root ganglia. The carcasses or wholesale cuts 
of carcasses of animals aged over 30 months and containing vertebr al column are 
identified by a clearly visible red stripe on the label refer red to in Article 13 or 15 
of Regulation (EC) No 1760/2000 (3).]]’ 
(ii)  In Part II of the Notes, footnote (3) is replaced by the following: 
‘(3)  The number of bovine carcasses or wholesale cuts of carcasses, from which remo val of the vertebral 
column is required shall be added to the Common Veterinar y Entr y Document (CVED) refer red to in 
Article 2(1) of Regulation (EC) No 136/2004.’ 
(iii)  In Part II of the Notes, the following footnote (*) is added: 
‘(*)  The remo val of specifi ed risk mater ial is not required if the meat or minced meat derives from animals 
born, continuously reared and slaughtere d in a third countr y or region of a third countr y classified in 
accordance with Decision 2007/453/EC as posing a negligible BSE risk.’ 
(b)  The model veteri nary certificate OVI is amended as follows: 
(i)  In Part II.1, Public Health Attestation, point II.1.9 is replaced by the following:  
‘(1) either  [II.1.9. with regar d to bovine spongif orm encephalopath y (BSE):  
(a) the countr y or region of dispatch is classified in accordance with Decision 
2007/453/EC as a countr y or region posing a negligible BSE risk;  
(1) either [(b) the animals, from whic h the meat or minced meat is derived, were not slaughter ed 
after stunning, by means of gas injected into the cranial cavity or killed by the 
same method or slaughtered by laceration after stunning of central nervous tissue 
by means of an elongat ed rod-shaped instr ument introduced into the cranial 
cavity;]  
(1) or [(b) the animals, from which the meat or minced meat is derived: 
(i)  were born, continuously reared and slaughter ed in a countr y or region 
classified in accordance with Decision 2007/453/EC as a countr y or region 
posing a negligible BSE risk; 
(ii)  were slaughtered after stunning by means of gas injected into the cranial 
cavity or killed by the same method or slaughte red by laceration after 
stunning of central nervous tissue by means of an elongat ed rod-shaped 
instr ument introduced into the cranial cavity;] 26.4.2017 L 108/14 Official Jour nal of the European Union EN     (c) the meat or minced meat does not contain and is not derived from specified risk 
mat erial as defined in point 1 of Annex V to Regulation (EC) No 999/2001 (*);  
(1) either [(d) the meat or minced meat is not derived from mech anically separate d meat, 
obtained from bones of ovine or capr ine animals;]  
(1) or [(d) the meat or minced meat is derived from mech anically separated meat obtained 
from bones of ovine or capr ine animals which were born, continuously reared and 
slaughter ed in a countr y or region classifie d in accordance with Decision 
2007/453/EC as a countr y or region posing a negligible BSE risk and in which 
there have been no BSE indigenous cases;]  
(1) [(e) (i)  the animals, from which the meat or minced meat is derived, originate from 
a countr y or region classified in accordance with Decision 2007/453/EC as 
a countr y or region posing an undeterm ined BSE risk; 
(ii)  the animals, from whic h the meat or minced meat is derived, have not been 
fed with meat-and-bone meal or greaves, as defined in the Terrestr ial Animal 
Health Code of the World Organisation for Animal Health; 
(iii)  the meat or minced meat was produced and handled in a manner whic h 
ensures that it did not contain and was not contaminate d with nervous and 
lymphatic tissues exposed during the deboning process.]]  
(1) or  [II.1.9. with regard to bovine spongif orm encephalopathy (BSE): 
(a)  the countr y or region is classified in accordance with Decision 2007/453/EC 
as a countr y or region posing a controlled BSE risk; 
(b)  the animals from whic h the meat or minced meat is derived were not killed 
after stunning by laceration of central nervous tissue by means of an 
elongat ed rod-shaped instr ument introduced into the cranial cavity , or by 
means of gas injecte d into the cranial cavity; 
(c)  the meat or minced meat does not contain and is not derived from specifi ed 
risk mate rial as defined in point 1 of Annex V to Regulation (EC) 
No 999/2001, or mechanically separate d meat obtained from bones of ovine 
or capr ine animals.]  
(1) or  [II.1.9. with regard to bovine spongif orm encephalopathy (BSE): 
(a)  the countr y or region has not been classif ied in accordance with Decision 
2007/453/EC or is classif ied as a countr y or region with an undeterm ined 
BSE risk; 
(b)  the animals from which the meat or minced meat is derived were not fed 
meat-and-bone meal or greav es derived from ruminants, as defined in the 
Terrestr ial Animal Health Code of the World Org anisation for Animal Health; 
(c)  the animals from whic h the meat or minced meat is derived were not killed 
after stunning by laceration of central nervous tissue by means of an 
elongat ed rod-shaped instr ument introduced into the cranial cavity , or by 
means of gas injecte d into the cranial cavity; 
(d)  the meat or minced meat does not contain and is not derived from: 
(i)  specified risk mate rial as defined in point 1 of Annex V to Regulation 
(EC) No 999/2001; 
(ii)  nervous and lymphatic tissues exposed during the deboning process; 
(iii)  mec hanically separated meat obtained from bones of ovine or capr ine 
animals.]’ 26.4.2017 L 108/15 Official Jour nal of the European Union EN     (ii)  In Part II of the Notes, the following footnot e (*) is added: 
‘(*)  The remo val of specifi ed risk mate rial is not required if the meat or minced meat derives from animals 
born, continuously reared and slaughtere d in a third countr y or region of a third countr y classifie d in 
accordance with Decision 2007/453/EC as posing a negligible BSE risk.’  26.4.2017 L 108/16 Official Jour nal of the European Union EN     ANNEX II 
Annex II to Implementing Regulation (EU) 2016/759 is amended as follows:  
(1) In Part III, the model certificate for impor ts of gelatine intended for human consump tion, Model GEL, is amended as 
follows: 
(a)  Part II.1, Public Health Attestation, is replaced by the following: 
‘I, the undersigned, declare that I am aware of the relevant provisions of Regulation (EC) No 178/2002 of the 
European Parliament and of the Council of 28 Januar y 2002 laying down the general principles and 
requirements of food law, establishing the European Food Safe ty Auth ority and laying down procedures in 
matt ers of food safety (OJ L 31, 1.2.2002, p. 1), Regulation (EC) No 852/2004 of the European Parliament and 
of the Council of 29 Apr il 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1) and Regulation (EC) 
No 853/2004 of the European Parliament and of the Council of 29 Apr il 2004 laying down specific hygiene 
rules for food of animal origin (OJ L 139, 30.4.2004, p. 55) and certify that the gelatine descr ibed above was 
produced in accordance with those requirements, in particular that: 
—  it comes from (an) establishment(s) imple menting a programme based on the Hazard analysis and critical 
control points (HA CCP) principles in accordance with Article 5 of Regulation (EC) No 852/2004, 
—  it has been produced from raw mater ials that met the requirements of Chapt ers I and II of Section XIV of 
Annex III to Regulation (EC) No 853/2004, 
—  it has been manufactured in compl iance with the conditions set out in Chapt er III of Section XIV of Annex 
III to Regulation (EC) No 853/2004, 
—  it satisfies the criteria of Chapt er IV of Section XIV of Annex III to Regulation (EC) No 853/2004 and of 
Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs 
(OJ L 338, 22.12.2005, p. 1); 
and, if of bovine, ovine and capr ine animal origin, 
it has been derived from animals whic h have passed ante mortem and post mortem inspections, 
(1) and, excep t for gelatine derived from hides and skins, 
(1) either  —  [it comes from a countr y or a region classified in accordance with Commission Decision 
2007/453/EC of 29 June 2007 establishing the BSE status of Member States or third countr ies or 
regions thereof according to their BSE risk (OJ L 172, 30.6.2007, p. 84) as a countr y or region 
posing a negligible BSE risk, 
—  the gelatine does not contain and is not derived from specifi ed risk mate rial as defined in point 1 
of Annex V to Regulation (EC) No 999/2001 of the European Parliament and of the Council of 
22 May 2001 laying down rules for the prevention, control and eradication of certain 
transmissible spongif orm encephalopathies (OJ L 147, 31.5.2001, p. 1) (2), 
—  the gelatine does not contain and is not derived from mechanically separate d meat obtained from 
bones of bovine, ovine or capr ine animals, excep t for gelatine derived from animals that were 
born, continuously reared and slaughter ed in a countr y or region classifie d in accordance with 
Decision 2007/453/EC as a countr y or region posing a negligible BSE risk in whic h there have 
been no BSE indig enous cases, 
—  the animals, from which the gelatine is derived were not slaughter ed after stunning by means of 
gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after 
stunning of central nervous tissue by means of an elongat ed rod-shaped instr ument introduced 
into the cranial cavity , excep t if the animals were born, continuously reared and slaughte red in 
a countr y or region classif ied in accordance with Decision 2007/453/EC as a countr y or region 
posing a negligible BSE risk, 26.4.2017 L 108/17 Official Jour nal of the European Union EN     —  (1) [the animals, from whic h the gelatine is derived, originate from a countr y or region classified 
in accordance with Decision 2007/453/EC as a countr y or region posing an undete rmined BSE 
risk, and the animals were not fed with meat-and-bone meal or grea ves, as defined in the 
Terrestr ial Animal Health Code of the World Org anisation for Animal Health], 
—  (1) [the animals, from whic h the gelatine is derived, originate from a countr y or region classified 
in accordance with Decision 2007/453/EC as a countr y or region posing an undete rmined BSE 
risk, and the gelatine was produced and handled in a manner which ensures that it did not 
contain and were not contaminated with nervous and lymph atic tissues exposed during the 
deboning process.]] 
or  —  [it comes from a countr y or a region classif ied in accordance with Decision 2007/453/EC of 
29 June 2007 establishing the BSE status of Member States or third countr ies or regions thereof 
according to their BSE risk (OJ L 172, 30.6.2007, p. 84) as a countr y or region posing 
a controlled BSE risk, 
—  the animals, from which the gelatine is derived, were not killed after stunning by laceration of 
central nervous tissue by means of an elongat ed rod-shaped instr ument introduced into the 
cranial cavity, or by means of gas injected into the cranial cavity, 
—  the gelatine does not contain and is not derived from specifi ed risk mate rial as defined in point 1 
of Annex V to Regulation (EC) No 999/2001, or mechanically separated meat obtained from 
bones of bovine, ovine or capr ine animals.] 
or  —  [it comes from a countr y or a region classif ied in accordance with Decision 2007/453/EC of 
29 June 2007 establishing the BSE status of Member States or third countr ies or regions thereof 
according to their BSE risk (OJ L 172, 30.6.2007, p. 84) as a countr y or region posing 
a negligible BSE risk, 
—  the gelatine is derived both from animals born, continuously reared and slaughter ed in a countr y 
or region with negligible BSE risk in accordance with Decision 2007/453/EC, and from animals 
born in a countr y or region classified in accordance with Decision 2007/453/EC as a countr y or 
region posing a controlled BSE risk, and which were not killed after stunning by laceration of 
central nervous tissue by means of an elongat ed rod-shaped instr ument introduced into the 
cranial cavity, or by means of gas injected into the cranial cavity, 
—  the gelatine does not contain and is not derived from specifi ed risk mate rial as defined in point 1 
of Annex V to Regulation (EC) No 999/2001, or mechanically separated meat obtained from 
bones of bovine, ovine or capr ine animals.] 
or  —  [it comes from a countr y or a region classif ied in accordance with Decision 2007/453/EC of 
29 June 2007 establishing the BSE status of Member States or third countr ies or regions thereof 
according to their BSE risk (OJ L 172, 30.6.2007, p. 84) as a countr y or region with an 
undeterm ined BSE risk, 
—  the animals, from whic h the gelatine is derived, were not fed meat-and-bone meal or greav es 
derived from ruminants, as defined in the Terrestr ial Animal health Code of the World 
Organisation for Animal Health, 
—  the animals, from which the gelatine is derived, were not killed after stunning by laceration of 
central nervous tissue by means of an elongat ed rod-shaped instr ument introduced into the 
cranial cavity, or by means of gas injected into the cranial cavity, 
—  the gelatine is not derived from: 
(i)  specifi ed risk mater ial as defined in point 1 of Annex V to Regulation (EC) No 999/2001; 
(ii)  nervous and lymphatic tissues exposed during the deboning process; 
(iii)  mechanically separated meat obtained from bones of bovine, ovine or capr ine animals.]’ 26.4.2017 L 108/18 Official Jour nal of the European Union EN     (b)  In Part II of the Notes, the following footnote (2) is added: 
‘(2)  The remo val of specif ied risk mater ial is not required if the gelatine derives from animals born, continuously 
reared and slaughter ed in a third countr y or region of a third countr y classified in accordance with Decision 
2007/453/EC as posing a negligible BSE risk.’  
(2) In Part IV, the model certificate for imports of collagen for human consum ption, Model COL, is amended as follows: 
(a)  Part II.1, Public Health Attestation, is replaced by the following: 
‘I, the undersigned, declare that I am aware of the relevant provisions of Regulation (EC) No 178/2002 of the 
European Parliament and of the Council of 28 Januar y 2002 laying down the general principles and 
requirements of food law, establishing the European Food Safe ty Auth ority and laying down procedures in 
matt ers of food safety (OJ L 31, 1.2.2002, p. 1), Regulation (EC) No 852/2004 of the European Parliament and 
of the Council of 29 Apr il 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1) and Regulation (EC) 
No 853/2004 of the European Parliament and of the Council of 29 Apr il 2004 laying down specific hygiene 
rules for food of animal origin (OJ L 139, 30.4.2004, p. 55) and certify that the collagen descr ibed above was 
produced in accordance with those requirements, in particular that: 
—  it comes from (an) establishment(s) imple menting a programme based on the Hazard analysis and critical 
control points (HA CCP) principles in accordance with Article 5 of Regulation (EC) No 852/2004, 
—  it has been produced from raw mate rials that met the requirements of Chapt ers I and II of Section XV of 
Annex III to Regulation (EC) No 853/2004, 
—  it has been manufactured in compliance with the conditions set out in Chapt er III of Section XV of Annex III 
to Regulation (EC) No 853/2004, 
—  it satisfi es the criteria of Chapt er IV of Section XV of Annex III to Regulation (EC) No 853/2004 and of 
Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs 
(OJ L 338, 22.12.2005, p. 1); 
(1) and, if of bovine, ovine and capr ine animal origin, 
it has been derived from animals whic h have passed ante mortem and post mortem inspections, 
(1) and, excep t for collagen derived from hides and skins, 
(1) either  —  [it comes from a countr y or a region classified in accordance with Commission Decision 
2007/453/EC of 29 June 2007 establishing the BSE status of Member States or third countr ies or 
regions thereof according to their BSE risk (OJ L 172, 30.6.2007, p. 84) as a countr y or region 
posing a negligible BSE risk, 
—  the collagen does not contain and is not derived from specif ied risk mate rial as defined in point 1 
of Annex V to Regulation (EC) No 999/2001 of the European Parliament and of the Council of 
22 May 2001 laying down rules for the prevention, control and eradication of certain 
transmissible spongif orm encephalopathies (OJ L 147, 31.5.2001, p. 1) (2), 
—  the collagen does not contain and is not derived from mech anically separated meat obtained from 
bones of bovine, ovine or capr ine animals, excep t for collagen derived from animals that were 
born, continuously reared and slaughter ed in a countr y or region classifie d in accordance with 
Decision 2007/453/EC as a countr y or region posing a negligible BSE risk in whic h there have 
been no BSE indig enous cases, 
—  the animals from whic h the collagen was derived have not been slaughtere d after stunning by 
means of gas injected into the cranial cavity or killed by the same method or slaughtered by 
laceration after stunning of central nervous tissue by means of an elongat ed rod-shaped 
instr ument introduced into the cranial cavity , excep t if the animals were born, continuously reared 
and slaughte red in a countr y or region classif ied in accordance with Decision 2007/453/EC as 
a countr y or region posing a negligible BSE risk, 26.4.2017 L 108/19 Official Jour nal of the European Union EN     —  (1) [the animals, from which the collagen is derived, originate from a countr y or region classified 
in accordance with Decision 2007/453/EC as a countr y or region posing an undete rmined BSE 
risk, and the animals were not fed with meat-and-bone meal or greaves, as defined in the OIE 
Terrestr ial Animal Health Code], 
—  (1) [the animals, from which the collagen is derived, originate from a countr y or region classified 
in accordance with Decision 2007/453/EC as a countr y or region posing an undete rmined BSE 
risk, and the collagen was produced and handled in a manner whic h ensures that it did not 
contain and were not contaminated with nervous and lymph atic tissues exposed during the 
deboning process.]] 
(1) or  —  [it comes from a countr y or a region classif ied in accordance with Decision 2007/453/EC of 
29 June 2007 establishing the BSE status of Member States or third countr ies or regions thereof 
according to their BSE risk (OJ L 172, 30.6.2007, p. 84) as a countr y or region posing 
a controlled BSE risk, 
—  the animals, from which the collagen is derived, were not killed, after stunning, by laceration of 
central nervous tissue by means of an elongat ed rod-shaped instr ument introduced into the 
cranial cavity, or by means of gas injected into the cranial cavity, 
—  the collagen does not contain and is not derived from specif ied risk mate rial as defined in point 1 
of Annex V to Regulation (EC) No 999/2001, or mechanically separated meat obtained from 
bones of bovine, ovine or capr ine animals.] 
(1) or  —  [it comes from a countr y or a region classif ied in accordance with Decision 2007/453/EC of 
29 June 2007 establishing the BSE status of Member States or third countr ies or regions thereof 
according to their BSE risk (OJ L 172, 30.6.2007, p. 84) as a countr y or region with an 
undeterm ined BSE risk, 
—  the animals, from whic h the collagen is derived, were not fed meat-and-bone meal or greav es 
derived from ruminants, as defined in the Terrestr ial Animal health Code of the World 
Organisation for Animal Health, 
—  the animals, from whic h the collagen is derived, were not killed after stunning by laceration of 
central nervous tissue by means of an elongat ed rod-shaped instr ument introduced into the 
cranial cavity, or by means of gas injected into the cranial cavity, 
—  the collage n is not derived from: 
(i)  specifi ed risk mater ial as defined in point 1 of Annex V to Regulation (EC) No 999/2001, 
(ii)  nervous and lymphatic tissues exposed during the deboning process, 
(iii)  mechanically separated meat obtained from bones of bovine, ovine or capr ine animals.]’ 
(b)  In Part II of the Notes, the following footnote (2) is added: 
‘(2)  The remo val of specifi ed risk mate rial is not required if the collage n derives from animals born, 
continuously reared and slaughter ed in a third countr y or region of a third countr y classified in accordance 
with Decision 2007/453/EC as posing a negligible BSE risk.’  
(3) In Part V, the model certificate for imports of raw mat erial for the production of gelatine/coll agen intended for 
human consump tion, Model RCG, is amended as follows: 
(a)  Part II.1, Public Health Attestation, is replaced by the following: 
‘I, the undersigned, declare that I am aware of the relevant provisions of Regulation (EC) No 178/2002 of the 
European Parliament and of the Council of 28 Januar y 2002 laying down the general principles and 
requirements of food law, establishing the European Food Safe ty Auth ority and laying down procedures in 
matt ers of food safety (OJ L 31, 1.2.2002, p. 1), Regulation (EC) No 852/2004 of the European Parliament and 
of the Council of 29 Apr il 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1), Regulation (EC) 
No 853/2004 of the European Parliament and of the Council of 29 Apr il 2004 laying down specific hygiene 26.4.2017 L 108/20 Official Jour nal of the European Union EN     rules for food of animal origin (OJ L 139, 30.4.2004, p. 55) and Regulation (EC) No 854/2004 of the European 
Parliament and of the Council of 29 Apr il 2004 laying down specific rules for the organisation of official 
controls on products of animal origin intended for human consump tion (OJ L 139, 30.4.2004, p. 206) and 
certify that the raw mate rials descr ibed above compl y with those requirements, in particular that: 
—  (1) [bones, hides and skins of domestic and farmed ruminant animals, pigs and poultr y and tendons and 
sinews descr ibed above are derived from animals which were slaughter ed in a slaughterhouse and the 
carcasses of which were found fit for human consum ption following ante and post mortem inspection,] 
and/or 
—  (1) [wild game hides, skins and bones descr ibed above are derived from killed animals whose carcasses have 
been found fit for human consum ption following post mortem inspection,] 
and/or 
—  (1) [fish skins and bones descr ibed above are derived from plants manufactur ing fisher y products for human 
consump tion author ised for expor t,] 
(1) and, if of bovine, ovine and capr ine animal origin, 
—  they have been derived from animals whic h passed ante mortem and post mortem inspections, 
(1) and, excep t for hides and skins of ruminants, 
(1) either  —  [they come from a countr y or a region classified in accordance with Decision 2007/453/EC of 
29 June 2007 establishing the BSE status of Member States or third countr ies or regions thereof 
according to their BSE risk (OJ L 172, 30.6.2007, p. 84) as a countr y or region posing 
a negligible BSE risk, 
—  they do not contain and are not derived from specifi ed risk mate rial as defined in point 1 of 
Annex V to Regulation (EC) No 999/2001 of the European Parliament and of the Council of 
22 May 2001 laying down rules for the prevention, control and eradication of certain 
transmissible spongif orm encephalopathies (OJ L 147, 31.5.2001, p. 1) (6), 
—  they do not contain and are not derived from mech anically separate d meat obtained from bones 
of bovine, ovine or capr ine animals, excep t for raw mat erials derived from animals that were 
born, continuously reared and slaughter ed in a countr y or region classifie d in accordance with 
Decision 2007/453/EC as a countr y or region posing a negligible BSE risk in whic h there have 
been no BSE indig enous cases, 
—  the animals, from whic h the raw mater ials are derived, were not slaughter ed after stunning by 
means of gas injected into the cranial cavity or killed by the same method or slaughtered by 
laceration after stunning of central nervous tissue by means of an elongat ed rod-shaped 
instr ument introduced into the cranial cavity , excep t if the animals were born, continuously reared 
and slaughte red in a countr y or region classif ied in accordance with Decision 2007/453/EC as 
a countr y or region posing a negligible BSE risk, 
—  (1) [the animals, from whic h the raw mat erials are derived, originate from a countr y or region 
classif ied in accordance with Decision 2007/453/EC as a countr y or region posing an 
undeterm ined BSE risk, and the animals were not fed with meat-and-bone meal or greav es, as 
defined in the Terrestr ial Animal Health Code of the World Org anisation for Animal Health], 
—  (1) [the animals, from whic h the raw mat erials are derived, originate from a countr y or region 
classif ied in accordance with Decision 2007/453/EC as a countr y or region posing an 
undeterm ined BSE risk, and the raw mate rials were produced and handled in a manner which 
ensures that they did not contain and were not contaminated with nervous and lymphatic tissues 
exposed during the deboning process.]] 26.4.2017 L 108/21 Official Jour nal of the European Union EN     (1) or  —  [they come from a countr y or a region classified in accordance with Decision 2007/453/EC of 
29 June 2007 establishing the BSE status of Member States or third countr ies or regions thereof 
according to their BSE risk (OJ L 172, 30.6.2007, p. 84) as a countr y or region posing 
a controlled BSE risk, 
—  the animals, from which the raw mater ials of bovine, ovine and capr ine animal origin intended for 
expor t are derived, were not killed, after stunning, by laceration of central nervous tissue by 
means of an elongat ed rod-shaped instr ument introduced into the cranial cavity , or by means of 
gas injected into the cranial cavity , 
—  the raw mater ials of bovine, ovine and capr ine animal origin do not contain and are not derived 
from specified risk mat erial as defined in point 1 of Annex V to Regulation (EC) No 999/2001, or 
mechanically separated meat obtained from bones of bovine, ovine or capr ine animals;] 
(1) or  —  [they come from a countr y or a region classified in accordance with Decision 2007/453/EC of 
29 June 2007 establishing the BSE status of Member States or third countr ies or regions thereof 
according to their BSE risk (OJ L 172, 30.6.2007, p. 84) as a countr y or region with an 
undeterm ined BSE risk, 
—  the animals, from which the raw mat erials are derived, were not fed meat-and-bone meal or 
greaves derived from ruminants, as defined in the Terrestr ial Animal Health Code of the World 
Organisation for Animal Health, 
—  the animals from which the raw mater ials of bovine, ovine and capr ine animal origin are derived, 
were not killed, after stunning, by laceration of central nervous tissue by means of an elongat ed 
rod-shaped instr ument introduced into the cranial cavity , or by means of gas injected into the 
cranial cavity, 
—  the raw mater ials are not derived from: 
(i)  specifi ed risk mater ial as defined in point 1 of Annex V to Regulation (EC) No 999/2001; 
(ii)  nervous and lymphatic tissues exposed during the de-boning process; 
(iii)  mechanically separated meat obtained from bones of bovine, ovine or capr ine animals.]’ 
(b)  In Part II of the Notes, the following footnote (6) is added: 
‘(6)  The remo val of specif ied risk mate rial is not required if the raw mater ials derive from animals born, 
continuously reared and slaughter ed in a third countr y or region of a third countr y classified in accordance 
with Decision 2007/453/EC as posing a negligible BSE risk.’  
(4) In Part VI, the model certificate for impor ts of treated raw mate rial for the production of gelatine/coll agen intended 
for human consump tion, Model TCG, is amended as follows: 
(a)  Part II.1, Public Health Attestation, is replaced by the following: 
‘I, the undersigned, certify that the treated raw mate rials descr ibed above compl y with the following 
requirements: 
—  they have been derived from establishments under the control of and liste d by the compet ent author ity, 
and 
—  (1) [bones, hides and skins of domestic and farmed ruminant animals, pigs and poultr y descr ibed above are 
derived from animals which were slaughte red in a slaughterh ouse and the carcasses of which were found fit 
for human consump tion following ante and post mortem inspection,] 
(1) and/or 
—  [wild gam e hides, skins and bones descr ibed above are derived from killed animals whose carcasses were 
found fit for human consump tion following post mortem inspection,] 26.4.2017 L 108/22 Official Jour nal of the European Union EN     (1) and/or 
—  [fish skins and bones descr ibed above are derived from plants manufactur ing fisher y products for human 
consump tion author ised for expor t,] 
and 
(1) either  —  [they are dried bones of species from bovine, ovine, capr ine, porcine and equine animals, 
including farmed and wild animals, poultr y including ratite s and feathered game for the 
production of collage n or gelat ine, they derived from healthy animals slaughtere d in a slaugh ­
terhouse, and they have been treated as follows: 
(1) either  —  [crushed to pieces of appro ximat ely 15 mm and degreased with hot water at a temperature of 
minimum 70 °C for at least 30 minut es, minimum 80 °C for at least 15 minutes, or minimum 
90 °C for at least 10 minutes , and then separated and subsequently washed and dried for at least 
20 minute s in a stream of hot air with an initial temperature of minimum 350 °C, or for 
15 minute s in a stream of hot air with an initial temperature of more than 700 °C.] 
(1) or  [sun-dr ied for a minimum of 42 days at an averag e temperature of at least 20 °C.] 
(1) or  [acid treatment such that the pH is maintained at less than 6 to the core for at least one hour before 
drying.]] 
(1) or  [they are hides and skins of farmed ruminant animals, pig skins, poultr y skins or wild game hides and 
skins, they derived from healthy animals and they: 
(1) either  —  [have undergone an alkali treatment whic h ensures a pH > 12 to the core followed by salting for 
at least 7 days] 
(1) or  [were dried for at least 42 days at a temperature of at least 20 °C.] 
(1) or  [hav e undergone an acid treatment that provides at least a pH of less than 5 to the core for 
a minimum of 1 hour .] 
(1) or  [hav e undergone an alkali treatment whic h ensures a pH > 12 to the core for at least 8 hours.]] 
(1) or  [they are bones, hides or skins of farmed ruminant animals, pig skins, poultr y skins, fish skins and 
wild game hides and skins from third countr ies, parts of third countr ies and territories referred to in 
Part IV of Annex I to Commission Implementing Regulation (EU) 2016/759 of 28 Apr il 2016 
drawing up lists of third countr ies, parts of third countr ies and territories from whic h Member States 
are to author ise the introduction into the Union of certain products of animal origin intende d for 
human consum ption, laying down certificate requirements, amending Regulation (EC) No 2074/2005 
and repealing Decision 2003/812/EC (OJ L 126, 14.5.2016, p. 13) that have undergone any other 
treatment than those listed above, and that come from establishments registere d or appro ved in 
accordance with to Regulation (EC) No 852/2004 or in accordance with Regulation (EC) 
No 853/2004 
(1) and, if of bovine, ovine and capr ine animal origin, 
—  they are derived from animals whic h passed ante mortem and post mortem inspections, 
(1) and, exce pt for hides and skins of ruminants, 
(1) either  —  [they come from a countr y or a region classified in accordance with Decision 2007/453/EC of 
29 June 2007 establishing the BSE status of Member States or third countr ies or regions thereof 
according to their BSE risk (OJ L 172, 30.6.2007, p. 84) as a countr y or region posing 
a negligible BSE risk, 
—  they do not contain and are not derived from specifi ed risk mate rial as defined in point 1 of 
Annex V to Regulation (EC) No 999/2001 of the European Parliament and of the Council of 
22 May 2001 laying down rules for the prevention, control and eradication of certain 
transmissible spongif orm encephalopathies (OJ L 147, 31.5.2001, p. 1) (4), 26.4.2017 L 108/23 Official Jour nal of the European Union EN     —  they do not contain and are not derived from mech anically separate d meat obtained from bones 
of bovine, ovine or capr ine animals, excep t for treated raw mate rials derived from animals that 
were born, continuously reared and slaughtere d in a countr y or region classifie d in accordance 
with Decision 2007/453/EC as a countr y or region posing a negligible BSE risk in which there 
have been no BSE indigenous cases, 
—  the animals, from whic h the treated raw mater ials are derived, were not slaughtered after stunning 
by means of gas injected into the cranial cavity or killed by the same method or slaughte red by 
laceration after stunning of central nervous tissue by means of an elongat ed rod-shaped 
instr ument introduced into the cranial cavity , excep t if the animals were born, continuously reared 
and slaughte red in a countr y or region classif ied in accordance with Decision 2007/453/EC as 
a countr y or region posing a negligible BSE risk, 
—  (1) [the animals, from which the treated raw mater ials are derived, originate from a countr y or 
region classif ied in accordance with Decision 2007/453/EC as a countr y or region posing an 
undeterm ined BSE risk, and the animals have not been fed with meat-and-bone meal or greaves, 
as defined in the Terrestr ial Animal Health Code of the World Organisation for Animal Health], 
—  (1) [the animals, from which the treated raw mater ials are derived, originate from a countr y or 
region classif ied in accordance with Decision 2007/453/EC as a countr y or region posing an 
undeterm ined BSE risk, the products were produced and handled in a manner whic h ensures that 
they did not contain and were not contaminated with nervous and lymph atic tissues exposed 
during the deboning process.]] 
(1) or  —  [they come from a countr y or a region classified in accordance with Decision 2007/453/EC of 
29 June 2007 establishing the BSE status of Member States or third countr ies or regions thereof 
according to their BSE risk (OJ L 172, 30.6.2007, p. 84) as a countr y or region posing 
a controlled BSE risk, 
—  the animals, from which the treated raw mat erials of bovine, ovine and capr ine animal origin 
destined for expor t are derived, were not killed, after stunning, by laceration of central nervous 
tissue by means of an elongat ed rod-shaped instr ument introduced into the cranial cavity , or by 
means of gas injected into the cranial cavity, 
—  the treated raw mate rials of bovine, ovine and capr ine animal origin do not contain and are not 
derived from specif ied risk mater ial as defined in point 1 of Annex V to Regulation (EC) 
No 999/2001, or mech anically separate d meat obtained from bones of bovine, ovine or capr ine 
animals;] 
(1) or  —  [they come from a countr y or a region classified in accordance with Decision 2007/453/EC of 
29 June 2007 establishing the BSE status of Member States or third countr ies or regions thereof 
according to their BSE risk (OJ L 172, 30.6.2007, p. 84) as a countr y or region with an 
undeterm ined BSE risk, 
—  the animals from which the treated raw mate rials were derived have not been fed meat-and-bone 
meal or greav es derived from ruminants, as defined in the Terrestr ial Animal Health Code of the 
World Org anisation for Animal Health, 
—  the animals, from which the treated raw mat erials of bovine, ovine and capr ine animal origin are 
derived, were not killed after stunning by laceration of central nervous tissue by means of an 
elongat ed rod-shaped instr ument introduced into the cranial cavity, or by means of gas injected 
into the cranial cavity, 
—  the treate d raw mater ials are not derived from: 
(i)  specifi ed risk mater ial as defined in point 1 of Annex V of Regulation (EC) No 999/2001; 
(ii)  nervous and lymphatic tissues exposed during the de-boning process; 
(iii)  mechanically separated meat obtained from bones of bovine, ovine or capr ine animals.]]’ 26.4.2017 L 108/24 Official Jour nal of the European Union EN     (b)  In Part II of the Notes, the following footnote (4) is added: 
‘(4)  The remo val of specified risk mat erial is not required if the treated raw mate rials derive from animals born, 
continuously reared and slaughter ed in a third countr y or region of a third countr y classified in accordance 
with Decision 2007/453/EC as posing a negligible BSE risk.’  26.4.2017 L 108/25 Official Jour nal of the European Union EN     ANNEX III 
In Annex I to Regulation (EU) No 28/2012, the model health certificate for impor t into the European Union of 
compo site products intende d for human consum ption is amended as follows:  
(1) In Point II.2.A of Part II, Health Information, point (E) is replaced by the following:  
‘(E) If containing mat erial from bovine, ovine or capr ine animals, the fresh meat and/or intest ines used in 
the preparation of the meat products and/or treated intes tines shall be subject to the following 
conditions depending on the BSE risk catego ry of the countr y of origin:  
(1) [(E.1) for imports from a countr y or a region classified in accordance with Decision 2007/453/EC as 
a countr y or region posing a negligible BSE risk:  
1. the animals, from which the products of bovine, ovine and capr ine animal origin are derived, have 
passed ante mortem and post mortem inspection;  
2. the products of bovine, ovine and capr ine animal origin do not contain and are not derived from 
specifi ed risk mater ial as defined in point 1 of Annex V to Regulation (EC) No 999/2001 of the 
European Parliament and of the Council (11);  
3. the products of bovine, ovine and capr ine animal origin do not contain and are not derived from 
mechanically separated meat obtained from the bones of bovine, ovine or capr ine animals, excep t 
for products of bovine, ovine and capr ine animal origin derived from animals that were born, 
continuously reared and slaughter ed in a countr y or region classif ied in accordance with Decision 
2007/453/EC as a countr y or region posing a negligible BSE risk in whic h there have been no BSE 
indigenous cases;  
4. the animals, from which the products of bovine, ovine and capr ine animal origin are derived, were 
not slaughter ed after stunning by means of gas injected into the cranial cavity or killed by the same 
method or slaughtered by laceration after stunning of central nervous tissue by means of an 
elongat ed rod-shaped instr ument introduced into the cranial cavity, excep t if the animals were 
born, continuously reared and slaughtered in a countr y or region classified in accordance with 
Decision 2007/453/EC as a countr y or region posing a negligible BSE risk;  
5. if the animals, from whic h the products of bovine, ovine and capr ine animal origin are derived, 
originat e from a countr y or region classif ied in accordance with Decision 2007/453/EC as posing 
an undetermined BSE risk, those animals were not fed with meat-and-bone meal or greaves, as 
defined in the Terrestr ial Animal Health Code of the World Org anisation for Animal Health, and 
the products were produced and handled in a manner which ensures that it did not contain and 
was not contaminated with nervous and lymph atic tissues exposed during the deboning process.]  
(1) or [(E2) for imports from a countr y or a region classified in accordance with Decision 2007/453/EC as 
a countr y or region posing a controlled BSE risk;  
1. the animals, from which the products of bovine, ovine and capr ine animal origin are 
derived, have passed ante mortem and post mortem inspection and were not killed after 
stunning by laceration of central nervous tissue by means of an elongat ed rod-shaped 
instr ument introduced into the cranial cavity , or by means of gas injected into the cranial 
cavity;  
2. the products of bovine, ovine and capr ine animal origin do not contain and are not derived 
from specified risk mater ial as defined in point 1 of Annex V to Regulation (EC) 
No 999/2001, or mechanica lly separated meat obtained from the bones of bovine, ovine or 
capr ine animals.  
(1) (4) 3. In the case of intestines originally sourced from a countr y or a region with a negligible BSE 
risk, imp orts of treate d intes tines have been subject to the following conditions:  
(a) the countr y or region was classified in accordance with Decision 2007/453/EC as 
a countr y or region posing a controlled BSE risk; 26.4.2017 L 108/26 Official Jour nal of the European Union EN     (b) the animals, from which the products of bovine, ovine and capr ine animal origin 
are derived, were born, continuously reared and slaughter ed in the countr y or 
region with a negligible BSE risk and have passed ante mortem and post mortem 
inspections;  
(1) (c) if the intestines are sourced from a countr y or region where there have been BSE 
indige nous cases: 
(i)  the animals were born after the date from whic h the ban on the feeding of 
ruminants with meat-and-bone meal and greav es derived from ruminants was 
enforced; or 
(ii)  the products of bovine, ovine and capr ine animal origin do not contain and are 
not derived from specified risk mater ial as defined in point 1 of Annex V to 
Regulation (EC) No 999/2001.]  
(1) or [(E.3) for imports from a countr y or a region classified in accordance with Decision 2007/453/EC as 
a countr y or region with an undeterm ined BSE risk:  
1. the animals, from which the products of bovine, ovine and capr ine animal origin are 
derived, were not fed meat-and-bone meal or greav es derived from ruminants, as defined in 
the Terrestr ial Animal health Code of the World Org anisation for Animal Health, and have 
passed ante mortem and post mortem inspections;  
2. the animals, from which the products of bovine, ovine and capr ine animal origin are 
derived, were not killed, after stunning, by laceration of central nervous tissue by means of 
an elongat ed rod-shaped instr ument introduced into the cranial cavity, or by means of gas 
injecte d into the cranial cavity;  
3. the products of bovine, ovine and capr ine animal origin are not derived from: 
(a)  specified risk mater ial as defined in point 1 of Annex V to Regulation (EC) 
No 999/2001; 
(b)  nervous and lymphatic tissues exposed during the deboning process; 
(c)  mech anically separate d meat obtained from bones of bovine, ovine or capr ine animals.  
(1) (4) 4. In the case of intestines originally sourced from a countr y or a region with a negligible BSE 
risk, imp orts of treate d intes tines have been subject to the following conditions:  
(a) the countr y or region was classified in accordance with Decision 2007/453/EC as 
a countr y or region posing a undete rmined BSE risk;  
(b) the animals, from which the products of bovine, ovine and capr ine animal origin 
are derived, were born, continuously reared and slaughter ed in the countr y or 
region with a negligible BSE risk and have passed ante mortem and post mortem 
inspections;  
(1) (c) if the intestines are sourced from a countr y or region where there have been BSE 
indige nous cases: 
(i)  the animals were born after the date from whic h the ban on the feeding of 
ruminants with meat-and-bone meal and greav es derived from ruminants was 
enforced; or 
(ii)  the products of bovine, ovine and capr ine animal origin do not contain and are 
not derived from specified risk mater ial as defined in point 1 of Annex V to 
Regulation (EC) No 999/2001.]’ 26.4.2017 L 108/27 Official Jour nal of the European Union EN     (2) In Part II of the Notes, the following footnote (11) is added: 
‘(11)  The remo val of specifi ed risk mater ial is not required if the products of bovine, ovine and capr ine animal 
origin derive from animals born, continuously reared and slaughtere d in a third countr y or region of a third 
countr y classified in accordance with Decision 2007/453/EC as posing a negligible BSE risk.’  26.4.2017 L 108/28 Official Jour nal of the European Union EN