EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10366/2015 CIS Rev. 4 
(POOL/G4/2015/10366/10366R4 -EN 
CIS Rev4.doc)  
[…](2015) XXX  draft  
  
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex III to Regulation (EC) No 853/2004 of the European Parliament and of 
the Council as regards the specific requirements for gelatine, collagen and highly refined 
products of animal origin intended for human consumption  
(Text with EEA relevance)    
EN 2   EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex III to Regulation (EC) No 853/2004 of the European Parliament and of 
the Council as regards the specific requirements for gelatine, collagen and highly refined 
products of animal origin intended for human consumption  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on  the Functioning of the European Union,  
Having regard to 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 origin1, 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 operators. That Regulation provides in particular that 
food business operators are to ensure compliance with specific requirements for raw 
materials for the production of gelatine and collagen intended for human consumption.  
(2) It is necessary to ensure that raw material s for the production of gelatine and collagen 
for human consumption come from source s that meet the public and animal healt h 
requirements  laid down in Union legislation . 
(3) The Union is highly dependent on import s of raw materials for the  production of 
gelatine and collagen . Establishments producing those raw materials apply  specific  
treatment s to exclude public and animal health  risks linked to those raw materials. It is 
therefore appropriate to allow th ose treatments prior to placing on the market in the 
Union . 
(4) It is appropriate to adapt the requirements for the production process for collagen to 
allow practical changes in cases where a change does not result in a differen t level of  
public health protection.  
(5) Analytical methods for verifying residue limits in gelatine and collagen should be 
adapted to the most appr opriate and most recently validated methods.  
(6) In order to ensure the safety of certain highly refined products , to ensure the 
enforcement of EU provisions  and to ensure fair competition as regards raw materials 
coming from within the U nion and from third c ountries , it is appropriate to harmonise 
conditions and lay down specific requirements for the production of certain highly 
refined products of animal origin intended for human consumption. The import of 
other products of animal origin for which Annex III of Regulation (EC) No 853/2004 
                                                 
1 OJ L 139, 30.4.2004, p. 55 .   
EN 3   EN does not lay down specific requirements, remains allowed in accordance with 
Regulation (EU) No 1079/20132. 
(7) Annex III to Regulation (EC) No 853/2004 should therefore be amended accordingly.  
(8) The measures provided for in this Re gulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex III to Regulation (EC) No 853/2004 is amended as follows:  
(1) Section XIV is amended as follows:  
(a) In Chapter I , point 4  is replaced by the following:  
"4. (a) Raw materials that have not undergone any preserving treatment other 
than chilling, freezing or quick -freezing must come from establishments 
registered or approved pursuant to Regulation (EC) No 852 /2004 or in 
accordance with this Regulation ,  
(b) The following t reated raw materials  may be used : 
(i) bones other than specified risk material  as defined in Article 3(1)(g) of 
Regulation (EC) No 999/2001 coming from establishments under the 
control of and  listed  by the competent authority , and that have been 
subjected to one of the following treatments : 
 crushed to pieces of approximately 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 minutes, or minimum 90°C for at least 10 minutes, 
and then separated  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  minutes in a stream of hot air with an initial temperature 
of more than 700°C;  
 sun-dried for a minimum of 42 days at an average temperature of at least 
20ºC;  
 acid treatment  such that the pH is maintained at less than 6 to the core for 
at least one hour before drying;  
(ii) hides and skins of farmed ruminant animals, pig skins, poultry skins and 
wild game hides and skins  coming from establishments under the control 
of and listed by the competent authority, and  that have been subjected to 
one of the following treatments:  
 treatment  with alkali to establ ish a pH >12 to the core followed by salting 
for at least seven days;  
 drying  for at least 42 days at a temperature of at least 20°C;  
                                                 
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) .  
EN 4   EN  acid treatment  such that the pH is maintained at less than 5 to the core for 
a minimum of one hour;  
 alkali treatment throughout at a pH > 12 for at least 8 hours ; 
(iii) bones other than specified risk material defined in Article 3(1)(g) of 
Regulation (EC) No 999/2001, hides and skins of farmed ruminant 
animals, pig skins, poultry 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 approved 
pursuant to Regulation (EC) No 852/2004 or in accordance with this 
Regulation .  
For the purposes of the first 2 indents of points (ii) of paragraph  (b), the 
duration of the treatments  may include the time of transportation . 
The treated raw materials referred to in points ( b) (i) and ( ii) of the first 
paragraph must be derived from:  
– domestic and farmed ruminant animals, pigs and poultry which have 
been slaughtered in a slaughterhouse and the carcasses of which have 
been found fit for human consumption following ante - and post -mortem 
inspection,  or 
– from killed wild game  whose carcasses have been found fit for huma n 
consumption following post -mortem inspection ." 
(b) In Chapter II , the following point  3 is added : 
"3. After  the veterinary checks provided for in Directive 97/78/EC, and 
without prejudice to  the conditions laid down in Article 8(4) of that 
Directive, raw materials  for the production of gelatine for human 
consumption, for which animal health certification is required, must be 
transported directly to the establishment at the place of destination.  
All precautions, including safe disposal of animal by -produc ts, waste, 
unused or surplus material, shall be taken to avoid risks of spreading 
diseases to animals."  
(c) Chapter IV is replaced by the following:  
"CHAPTER IV: REQUIREMENTS FOR FINISHED PRODUCTS  
Food business operators must ensure that gelatine 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  
Zn 50 ppm  
SO 2 (European Pharmacopoeia, latest edition)  50 ppm   
EN 5   EN H2O2 (European Pharmacopoeia, 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 manufacturing collagen must ensure compliance with 
the requirements of this section. Without prejudice to other provisions, 
products derived from collagen must be made from collagen which complies 
with the requirements of this section.  
(b) In Chapter I , point 4  is replaced by the following:  
"4. (a) Raw materials that have not undergone any preserving treatment other 
than chilling, freezing or quick -freezing must come from establishments 
registered or approved pursuant to Regulation (EC) No 852/2004 or in 
accordance with this Regulation . 
(b) The following treated r aw materials may be used:   
(i) bones  other than specified risk material as defined in Article 3(1)(g) of 
Regulation (EC) No 999/2001 coming from establishments under the 
control of and listed by the competent authority, and that have been 
subjected to one of the following treatments:  
 crushed to pieces of approximately 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  minutes, or minimum 90°C for at 
least 10 minutes, and then separated  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  minutes in a stream of 
hot air with an initial temperature of more than 700°C;  
 sun-dried for a minimum of 42 days at an average temperature of at 
least 20ºC;  
 acid treatment  such that the pH is maintained at less than 6 to the 
core for at least one hour before drying;  
(ii) hides and skins of farmed ruminant animals, pig skins, poultry skins and 
wild game hides and skins  coming from establishments under the control 
of and listed by the competent authority, 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 seven 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 one hour;  
 alkali treatment throughout at a pH > 12 for at least 8 hours ; 
(iii) bones oth er than specified risk material  defined in Article 3(1)(g) of 
Regulation (EC) No 999/2001, hides and skins of farmed ruminant 
animals, pig skins, poultry skins, fish hides and wild game hides and  
EN 6   EN skins that have undergone any other treatment than those specified in 
point ( i) or ( ii) and that come from establishments registered or approved 
pursuant to Regulation (EC) No 852/2004 or in accordance with this 
Regulation.  
For the purposes of the first 2 indents of point (ii) of paragraph  (b), the duration 
of the treatments may inc lude the time of transportation.  
The treated raw materials referred to in points (a) and (b) of the first paragraph 
must be derived from:  
– domestic and farmed ruminant animals, pigs and poultry which have 
been slaughtered in a slaughterhouse and the carcass es of which have 
been found fit for human consumption following ante - and post -mortem 
inspection, or  
– from killed wild game whose carcasses have been found fit for human 
consumption following post -mortem inspection ." 
(c) In Chapter II, t he following point 3 is added : 
"3. After  the veterinary checks provided for in Directive 97/78/EC, and without 
prejudice to  the conditions laid down in Article 8(4) of that Directive, raw 
materials for the production of collagen for human consumption, for which 
animal health certification is required, must be transported directly to the 
establishment at the place  of destination.  
All precautions, including safe disposal of animal by -product s, waste, unused 
or surplus material, shall be taken to avoid risks of spreading diseases to 
animals."  
(d) In Chapter III , point 1  is replaced by the following:  
"1. The production process for collagen must ensure that:  
(a) all ruminant bone material derived from animals born, reared or slaughtered in 
countries or regions with a controlled or undetermined BSE risk as determined 
in accordance with Article 5 of Regulation (EC) No 999/2001 is subjected to a 
process which ensures that all bone material is finely crushed and degreased 
with hot water and treated with dilute hydrochloric acid (at a minimum 
concentration of 4 % and pH <  1,5) over a period of at least two 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 ,  
– extrusion,  
(ii) or any approved equivalent process ; 
(b) raw material s other than that referred to in point (a) must be subjected 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 ,   
EN 7   EN – extrusion,  
(ii) or any approved equivalent process ."  
(e) Chapter IV is replaced by the following:  
"CHAPTER IV: REQUIREMENTS FOR FINISHED PRODUCTS  
Food business operators 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  
Zn 50 ppm  
SO 2 (European Pharmacopoeia, latest edition)  50 ppm  
H2O2 (European Pharmacopoeia, latest edition  )  10 ppm  
" 
(3) The following Section XVI is added:  
"SECTION XVI: HIGHLY REFINED CHONDROITINE S ULPHATE, 
HYALURONIC ACID, OTHER HYDOL YSED CARTILAGE PRODUCTS, 
CHITOSAN, GLUCOSAMINE, RENNET , ISINGLASS  AND AMINO ACIDS  
1. Food business operators manufacturing 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) isinglass ,  
(h) amino acids  that are authorised as food additives in accordance with 
Commission Regulation  (EU) No 1333/20083, 
must ensure that the  treatment of the raw materials used eliminates any animal 
or public health risk. 
                                                 
3   
EN 8   EN 2. The raw materials used for the manufacturing of the highly refined products 
referred to in point 1 must derive from :  
(a) animals , including feathers thereof,  which have been slaughtered in a 
slaughterhouse a nd whose carca sses have been found fit for human 
consumption following ante -mortem and post -mortem inspection, or;   
(b) fishery products complying with Section VIII ." 
Human hair may not be used as a source for the manufacture of amino acids. " 
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 . 
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