COMMISSION REGUL ATION (EU) 2016/355 
of 11 March 2016 
amending Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the 
Council as regards the specif ic requirements for gelatine, collagen and highly refined products of 
animal origin intended for human consumption 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regar d to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 Apr il 2004 laying 
down specifi c hygiene rules for food of animal origin (1), and in particular Article 10(1) thereof, 
Whereas: 
(1)  Regulation (EC) No 853/2004 lays down specific rules on the hygiene of food of animal origin for food business 
operat ors. That Regulation provides in particular that food business operat ors are to ensure compl iance with 
specific requirements for raw mate rials for the production of gelatine and collagen intended for human 
consum ption. 
(2)  It is necessar y to ensure that raw mater ials for the production of gelatine and collagen for human consump tion 
come from sources that meet the public and animal health requirements laid down in Union legislation. 
(3)  The Union is highly dependent on impor ts of raw mater ials for the production of gelatine and collage n. 
Establishments producing those raw mater ials apply specif ic treatments to excl ude public and animal health risks 
linked to those raw mate rials. It is theref ore appropr iate to allow those treatments prior to placing on the mark et 
in the Union. 
(4)  It is appropr iate to adapt the requirements for the production process for collagen to allow practical change s in 
cases where a chang e does not result in a different level of public health protect ion. 
(5)  Analytical methods for verifying residue limits in gelatine and collagen should be adapt ed to the most 
appropr iate and most recently validate d methods. 
(6)  In order to ensure the safety of certain highly refined products, to ensure the enforcement of EU provisions and 
to ensure fair compet ition as regards raw mate rials coming from within the Union and from third countr ies, it is 
appropr iate to harmonise conditions and lay down specifi c requirements for the production of certain highly 
refined products of animal origin intended for human consum ption. The import of other products of animal 
origin for which Annex III to Regulation (EC) No 853/2004 does not lay down specific requirements, remains 
allowed in accordance with Commission Regulation (EU) No 1079/2013 (2). 
(7)  Annex III to Regulation (EC) No 853/2004 should theref ore be amended according ly. 
(8)  The measures provided for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed, 12.3.2016 L 67/22 Official Jour nal of the European Union EN     
(1)OJ L 139, 30.4.2004, p. 55. 
(2)Commission Regulation (EU) No 1079/2013 of 31 October 2013 laying down transitional measures for the application of Regulations 
(EC) No 853/2004 and (EC) No 854/2004 of the European Parliament and of the Council (OJ L 292, 1.11.2013, p. 10). HAS ADOPTED THIS REGUL ATION: 
Article 1 
Annex III to Regulation (EC) No 853/2004 is amended as follows:  
(1) Section XIV is amended as follows: 
(a)  in Chapt er I, point 4 is replaced by the following: 
‘4.  (a)  Raw mat erials that have not undergone any preser ving treatment other than chilling, freezing or quic k- 
freezing must come from establishments registered or appro ved pursuant to Regulation (EC) 
No 852/2004 or in accordance with this Regulation, 
(b)  The following treate d raw mater ials may be used: 
(i)  bones other than specified risk mater ial as defined in Article 3(1)(g) of Regulation (EC) 
No 999/2001 coming from establishments under the control of and listed by the compet ent 
author ity, and that have been subjected to one of the following treatments: 
—  crushed to pieces of appro ximatel y 15 mm and degreased with hot water at a temperature of 
minimum 70 °C for at least 30 minutes , minimum 80 C for at least 15 minute s, or minimum 
90 °C for at least 10 minute s, and then separate d and subsequently washed and dried for at least 
20 minutes 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, 
—  sun-dr ied for a minimum of 42 days at an average temperature of at least 20 °C, 
—  acid treatment such that the pH is maintained at less than 6 to the core for at least 1 hour before 
drying; 
(ii)  hides and skins of farmed ruminant animals, pig skins, poultr y skins and wild game hides and skins 
coming from establishments under the control of and liste d by the compet ent author ity, and that 
have been subjected to one of the following treatments: 
—  treatment with alkali to establish a pH > 12 to the core followed by salting for at least 7 days, 
—  drying for at least 42 days at a temperature of at least 20 °C, 
—  acid treatment such that the pH is maintained at less than 5 to the core for a minimum of 
1 hour , 
—  alkali treatment throughout at a pH > 12 for at least 8 hours; 
(iii)  bones other than specified risk mate rial defined in Article 3(1)(g) of Regulation (EC) No 999/2001, 
hides and skins of farmed ruminant animals, pig skins, poultr y skins, fish hides and wild game hides 
and skins that have undergone any other treatment than those specified in point (i) or (ii) and that 
come from establishments registered or appro ved pursuant to Regulation (EC) No 852/2004 or in 
accordance with this Regulation. 
For the purposes of the first 2 indents of point (b)(ii), the duration of the treatments may include the time of 
transpor tation. 
The treated raw mater ials refer red to in points (b)(i) and (b)(ii) must be derived from: 
—domestic and farmed ruminant animals, pigs and poultr y whic h have been slaughter ed in a slaugh ­
terhouse and the carcasses of whic h have been found fit for human consum ption following ante- and 
post-mor tem inspection, or 12.3.2016 L 67/23 Official Jour nal of the European Union EN     —  from killed wild game whose carcasses have been found fit for human consum ption following post- 
mor tem inspection.’; 
(b)  in Chapt er II, the following point 3 is added: 
‘3.  After the veterinar y checks provided for in Directive 97/78/EC, and without prejudice to the conditions laid 
down in Article 8(4) of that Directive, raw mater ials for the production of gelatine for human consump tion, 
for which animal health certification is required, must be transpor ted directly to the establishment at the 
place of destination. 
All precautions, including safe disposal of animal by-pro ducts, waste, unused or surplus mate rial, shall be 
take n to avoid risks of spreading diseases to animals.’; 
(c)  Chapt er IV is replaced by the following: 
‘CHAPTER IV: REQUIREMENTS FOR FINISHED PRODUCTS 
Food business operat ors must ensure that gelatine compl ies with the residue limits set out in the following table. 
Residue Limit 
As 1 ppm 
Pb 5 ppm 
Cd 0,5 ppm 
Hg 0,15 ppm 
Cr 10 ppm 
Cu 30 ppm 
Zn 50 ppm 
SO2 (European Phar macopoeia, latest edition) 50 ppm 
H2O2 (European Phar macopoeia, latest edition) 10 ppm’   
(2) Section XV is amended as follows: 
(a)  in the introduction, point 1 is replaced by the following: 
‘1.  Food business operators manufactur ing collage n must ensure compl iance with the requirements of this 
section. Without prejudice to other provisions, products derived from collagen must be made from collage n 
whic h compl ies with the requirements of this section.’; 
(b)  in Chapt er I, point 4 is replaced by the following: 
‘4.  (a)  Raw mat erials that have not undergone any preser ving treatment other than chilling, freezing or quic k- 
freezing must come from establishments registered or appro ved pursuant to Regulation (EC) 
No 852/2004 or in accordance with this Regulation. 12.3.2016 L 67/24 Official Jour nal of the European Union EN     (b)  The following treate d raw mater ials may be used: 
(i)  bones other than specified risk mater ial as defined in Article 3(1)(g) of Regulation (EC) 
No 999/2001 coming from establishments under the control of and listed by the compet ent 
author ity, and that have been subjected to one of the following treatments: 
—  crushed to pieces of appro ximatel y 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 minute s, or minimum 
90 °C for at least 10 minute s, and then separate d and subsequently washed and dried for at least 
20 minutes 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, 
—  sun-dr ied for a minimum of 42 days at an average temperature of at least 20 °C, 
—  acid treatment such that the pH is maintained at less than 6 to the core for at least 1 hour before 
drying; 
(ii)  hides and skins of farmed ruminant animals, pig skins, poultr y skins and wild game hides and skins 
coming from establishments under the control of and liste d by the compet ent author ity, and that 
have been subjected to one of the following treatments: 
—  treatment with alkali to establish a pH > 12 to the core followed by salting for at least 7 days, 
—  drying for at least 42 days at a temperature of at least 20 °C, 
—  acid treatment such that the pH is maintained at less than 5 to the core for a minimum of 
1 hour , 
—  alkali treatment throughout at a pH > 12 for at least 8 hours; 
(iii)  bones other than specified risk mate rial defined in Article 3(1)(g) of Regulation (EC) No 999/2001, 
hides and skins of farmed ruminant animals, pig skins, poultr y skins, fish hides and wild game hides 
and skins that have undergone any other treatment than those specified in point (i) or (ii) and that 
come from establishments registered or appro ved pursuant to Regulation (EC) No 852/2004 or in 
accordance with this Regulation. 
For the purposes of the first 2 indents of point (b)(ii), the duration of the treatments may include the time of 
transpor tation. 
The treated raw mater ials refer red to in point (b) must be derived from: 
—domestic and farmed ruminant animals, pigs and poultr y whic h have been slaughter ed in a slaugh ­
terhouse and the carcasses of whic h have been found fit for human consum ption following ante- and 
post-mor tem inspection, or 
—  from killed wild game whose carcasses have been found fit for human consum ption following post- 
mor tem inspection.’; 
(c)  in Chapt er II, the following point 3 is added: 
‘3.  After the veterinar y checks provided for in Directive 97/78/EC, and without prejudice to the conditions laid 
down in Article 8(4) of that Directive, raw mate rials for the production of collagen for human consum ption, 
for which animal health certification is required, must be transpor ted directly to the establishment at the 
place of destination. 
All precautions, including safe disposal of animal by-pro ducts, waste, unused or surplus mate rial, shall be 
take n to avoid risks of spreading diseases to animals.’; 12.3.2016 L 67/25 Official Jour nal of the European Union EN     (d)  in Chapt er III, point 1 is replaced by the following: 
‘1.  The production process for collagen must ensure that: 
(a)  all ruminant bone mate rial derived from animals born, reared or slaughter ed in countr ies or regions with 
a controlled or undetermined BSE risk as deter mined in accordance with Article 5 of Regulation (EC) 
No 999/2001 is subjected to a process whic h ensures that all bone mater ial is finely crushed and 
degreased with hot water and treated with dilut e hydrochlori c acid (at a minimum concentration of 4 % 
and pH < 1,5) over a period of at least 2 days; this treatment must be followed by pH adjustment using 
acid or alkali followed by: 
(i)  either one or more rinses and at least one of the following processes: 
—  filtration, 
—  milling, 
—  extr usion, 
(ii)  or any appro ved equivalent process; 
(b)  raw mater ials other than that refer red to in point (a) must be subjecte d to a treatment involving washing, 
pH adjustment using acid or alkali followed by: 
(i)  either one or more rinses and at least one of the following processes: 
—  filtration, 
—  milling, 
—  extr usion, 
(ii)  or any appro ved equivalent process.’; 
(e)  Chapt er IV is replaced by the following: 
‘CHAPTER IV: REQUIREMENTS FOR FINISHED PRODUCTS 
Food business operat ors must ensure that collagen complies with the residue limits set out in the following table. 
Residue Limit 
As 1 ppm 
Pb 5 ppm 
Cd 0,5 ppm 
Hg 0,15 ppm 
Cr 10 ppm 
Cu 30 ppm 12.3.2016 L 67/26 Official Jour nal of the European Union EN     Residue Limit 
Zn 50 ppm 
SO2 (European Phar macopoeia, latest edition) 50 ppm 
H2O2 (European Phar macopoeia, latest edition) 10 ppm’   
(3) the following Section XVI is added: 
‘SECTION XVI: HIGHL Y REFINED CHONDR OITIN SULPHA TE, HYALURONIC ACID, OTHER HYDR OLYSED CARTIL AGE 
PRODUCTS, CHITOSAN, GLU COS AMINE, RENNET , ISINGL ASS AND AMINO ACIDS  
1. Food business operat ors manufactur ing the following highly refined products of animal origin: 
(a)  chondroitin sulphate, 
(b)  hyaluronic acid, 
(c)  other hydrolysed cartilage products, 
(d)  chitosan, 
(e)  glucosamine, 
(f)  rennet, 
(g)  ising lass, 
(h)  amino acids that are author ised as food additives in accordance with Regulation (EC) No 1333/2008 of the 
European Parliament and of the Council (*), 
must ensure that the treatment of the raw mater ials used eliminates any animal or public health risk.  
2. The raw mater ials used for the manuf actur ing of the highly refined products refer red to in point 1 must derive 
from: 
(a)  animals, including feathers thereof, whic h have been slaughtered in a slaughterh ouse and whose carcasses 
have been found fit for human consum ption following ante-mor tem and post-mor tem inspection, or; 
(b)  fisher y products complying with Section VIII. 
Human hair may not be used as a source for the manuf acture of amino acids.  
(*)Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food 
additives (OJ L 354, 31.12.2008, p. 16).’ 
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the 
European Union. 12.3.2016 L 67/27 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, 11 Marc h 2016. 
For the Commission 
The Presid ent 
Jean-Claude JUNCKER  12.3.2016 L 67/28 Official Jour nal of the European Union EN