II 
(Non-legislative acts)  
REGULATIONS  
COMMISSION REGULATION (EU) No 790/2010  
of 7 September 2010  
amending Annexes VII, X and XI to Regulation (EC) No 1774/2002 of the European Parliament and 
of the Council laying down health rules concerning animal by-products not 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 1774/2002 of the 
European Parliament and of the Council of 3 October 2002 
laying down health rules concerning animal by-products not 
intended for human consumption (  1 ), and in particular the 
first and second subparagraphs of Article 32(1) thereof,  
Whereas:  
(1) Regulation (EC) No 1774/2002 lays down animal and 
public health rules concerning animal by-products not 
intended for human consumption.  
(2) Article 19 of that Regulation provides that processed 
animal protein and other processed products that could 
be used as feed material are to be placed on the market 
only if they comply with certain requirements. In this 
respect, Annex VII to that Regulation sets out specific 
hygiene requirements for the processing and placing on 
the market of such products.  
(3) In addition, Article 29 of Regulation (EC) No 1774/2002 
provides that the importation into, and the transit 
through the Union of the products referred to in 
Annex VII may take place only if such products 
comply with certain requirements. Those requirements 
include that the products must come from a third 
country or parts of third countries on a list to be 
drawn up and updated in accordance with the 
procedure referred to in that Article, except where 
Annex VII to Regulation (EC) No 1774/2002 provides 
otherwise.  (4) Colostrum is a feed material of animal origin, within the 
meaning of the definition laid down in point 23 of 
Annex I to Regulation (EC) No 1774/2002.  
(5) Part A of Chapter V of Annex VII to that Regulation does 
not set out any specific requirements for the production 
of colostrum or colostrum products. That Part only sets 
out the general principle that colostrum must be 
produced under conditions offering adequate guarantees 
as regards animal health.  
(6) In addition, Part B of Chapter V of Annex VII to Regu ­
lation (EC) No 1774/2002 does not set out specific 
requirements for the importation of colostrum and 
colostrum products and the Commission has not laid 
down any list of third countries or parts of third 
countries from which imports of colostrum are 
accepted. Accordingly, the importation of colostrum or 
colostrum products into the European Union is currently 
not authorised.  
(7) There is an interest to import into the Union colostrum 
and colostrum products as feed material for farmed 
animals and for technical purposes. Economic operators 
have indicated their interest in the use of colostrum and 
colostrum products for the production of feed material 
and for technical purposes.  
(8) The demand for such products from economic operators 
should be met and rules should therefore be laid down 
for the importation of such animal by-products. 
However, colostrum is an animal by-product which 
may pose a risk for the transmission of certain 
diseases, such as foot-and-mouth disease, tuberculosis, 
brucellosis and enzootic-bovine-leukosis to susceptible 
animals. In order to safeguard animal health, the 
importation of colostrum and colostrum products 
should therefore be subject to certain conditions.EN 8.9.2010 Official Journal of the European Union L 237/1  
( 1 ) OJ L 273, 10.10.2002, p. 1.(9) In accordance with the first paragraph of Article 28 of 
Regulation (EC) No 1774/2002 the provisions applicable 
to the importation of products referred to in Annex VII 
to that Regulation from third countries are not to be 
more favourable or less favourable than those applicable 
to the production and marketing of those products in the 
Union. The specific requirements set out for the 
importation of whey and colostrum or colostrum 
products should therefore also apply to the production 
and placing on the market of those animal by-products 
in the Union.  
(10) The opinion of the European Food Safety Authority, 
adopted on 29 March 2006, related to the animal 
health risks of feeding animals with ready-to-use dairy 
products without further treatment (  1 ), confirmed that 
specific hygiene requirements and treatments for milk 
and milk-based products are to be established to limit 
the risk of transmitting infectious diseases, in particular 
through feeding of milk or milk products to animals of 
species susceptible to foot-and-mouth disease. In the 
absence of suitable scientific data, the aforementioned 
opinion does not recommend any treatment which 
would provide the necessary guarantees that the 
considered pathogens are effectively inactivated in 
colostrum while preserving antibodies contained therein.  
(11) In the absence of approved treatments and in order to 
prevent the transmission of possible animal diseases 
through colostrum and colostrum products, it is appro ­
priate to establish health requirements for those animal 
by-products based on guarantees at origin.  
(12) In particular, as regards foot-and-mouth disease 
prevention, colostrum and colostrum products should 
be obtained from animals free of foot-and-mouth 
disease and not at risk of contracting this disease. 
Imports of colostrum and colostrum products should 
therefore be limited to bovine colostrum and its 
products from countries approved for imports of raw 
milk. Imports of colostrum and colostrum products 
should be limited to bovine colostrum and its products 
from countries where the risk of foot-and-mouth disease 
is limited.  
(13) Commission Decision 2004/438/EC of 29 April 2004 
laying down animal and public health and veterinary 
certifications conditions for introduction in the 
Community of heat-treated milk, milk-based products 
and raw milk intended for human consumption (  2 ) 
provides that Member States are to authorise imports 
of raw milk and raw milk-based products only from 
the third countries listed in column A of Annex I 
thereto. The list of third countries from which the 
importation into the Union of colostrum and 
colostrum products should be authorised should 
therefore be the same as the list of third countries set out in column A of Annex I to Decision 2004/438/EC. 
Chapter V of Annex VII to Regulation (EC) No 
1774/2002 should therefore refer to that list.  
(14) The health status with regard to bovine tuberculosis, 
bovine brucellosis and enzootic-bovine-leukosis of the 
herds from which colostrum and colostrum products 
originate should also be taken into account, in particular 
where such animal by-products are intended for feeding 
animals or the production of certain technical products. 
The herds from which colostrum and colostrum products 
originate should be free of those diseases.  
(15) Council Directive 64/432/EEC of 26 June 1964 on 
animal health problems affecting intra-Community trade 
in bovine animals and swine (  3 ) applies to intra-Union 
trade in bovine animals and sets out provisions for 
recognising herds as being disease-free. It lays down 
the definitions for officially tuberculosis-free bovine 
herds, officially brucellosis-free bovine herds and officially 
enzootic-bovine-leukosis-free herds. The requirements for 
placing on the market and importation of colostrum and 
colostrum products should therefore take account of 
those definitions.  
(16) Colostrum and colostrum products should have 
undergone a primary high temperature short term 
treatment for their preservation. In addition, the placing 
on the market, including the importation, of such animal 
by-products should only be allowed if they originate 
from animals that do not show clinical signs of any 
disease communicable through colostrum to humans or 
animals. Colostrum and colostrum products should 
therefore be produced from bovine animals kept in 
areas for which guarantees can be provided that foot- 
and-mouth disease has not occurred within at least one 
incubation period of 21 days after the collection and 
before such colostrum or colostrum products are 
placed on the market in Member States.  
(17) Part A of Chapter V of Annex VII to Regulation (EC) No 
1774/2002 provides that whey to be fed to animals of 
species susceptible to foot-and-mouth disease and 
produced from milk treated in accordance with the 
rules set out therein must be collected at least 16 
hours after milk clotting and its pH must be recorded 
as below 6,0 before transport to animal holdings.  
(18) Chapter 2 of Annex X to Regulation (EC) No 1774/2002 
sets out a single model health certificate for milk and 
milk products not intended for human consumption 
originating in third countries for dispatch to or for 
transit through the European Union. That model 
certificate should be amended in order to cover also 
colostrum and colostrum products, as well as to reflect 
the new rules concerning whey.EN L 237/2 Official Journal of the European Union 8.9.2010  
( 1 ) The EFSA Journal (2006) 347, p. 1.  
( 2 ) OJ L 154, 30.4.2004, p. 72.  (  3 ) OJ 121, 29.7.1964, p. 1977/64.(19) Annex XI to Regulation (EC) No 1774/2002 sets out lists 
of third countries from which Member States may 
authorise imports of certain animal by-products not 
intended for human consumption. Part I of that Annex 
should be amended to take account of the rules for the 
importation of colostrum and colostrum products.  
(20) Cameroon applied for the authorisation for imports of 
apiculture animal by-products. Cameroon is already auth ­
orised for the imports of honey for human consumption. 
Part XII of Annex XI should be amended appropriately 
and Cameroon should be authorised for the imports of 
apiculture animal by-products.  
(21) Annexes VII, X and XI to Regulation (EC) No 1774/2002 
should therefore be amended accordingly.  
(22) A transitional period should be provided for after the 
date of entry into force of this Regulation, in order to 
provide the necessary time for stakeholders to comply 
with the new rules and to allow for the continued 
importation into the European Union of the animal by- 
products concerned, as provided for in Regulation (EC) 
No 1774/2002, before the amendments introduced by 
this Regulation.  (23) The measures provided for in this Regulation are in 
accordance with the opinion of the Standing 
Committee on the Food Chain and Animal Health,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annexes VII, X and XI to Regulation (EC) No 1774/2002 are 
amended in accordance with the Annex to this Regulation.  
Article 2  
Consignments of milk and milk products not intended for 
human consumption accompanied by a health certificate 
completed and signed in accordance with the appropriate 
model set out in Chapter 2 of Annex X to Regulation (EC) 
No 1774/2002 before the date of entry into force of this 
Regulation shall continue to be accepted for importation into 
the Union until 30 September 2010, where those certificates 
were completed and signed before 31 August 2010.  
Article 3  
This Regulation shall enter into force on the 20th day following 
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, 7 September 2010.  
For the Commission  
The President  
José Manuel BARROSOEN 8.9.2010 Official Journal of the European Union L 237/3ANNEX  
Annexes VII, X and XI to Regulation (EC) No 1774/2002 are amended as follows:  
1. in Annex VII, Chapter V is amended as follows:  
(a) the heading is replaced by the following:  
‘CHAPTER V  
Specific requirements for milk, milk products, colostrum and colostrum products’ ; 
(b) Part A is amended as follows:  
(i) paragraph 3 is replaced by the following:  
‘3. Whey to be fed to animals of species susceptible to foot-and-mouth disease and produced from milk 
treated in accordance with paragraph 1 must:  
(a) either be collected at least 16 hours following milk clotting and its pH must be recorded as below 6,0 
before transport to animal holdings; or  
(b) have been produced at least 21 days before shipping and during that period no case of foot-and-mouth 
disease has been detected in the Member State of origin.’;  
(ii) the following paragraph 6 is added:  
‘6. Colostrum and colostrum products must:  
6.1. be obtained from bovine animals kept on a holding on which all bovine herds are recognised as officially 
tuberculosis-free, officially brucellosis-free and officially enzootic-bovine-leukosis-free as defined in 
Article 2(2)(d), (f) and (j) of Directive 64/432/EEC;  
6.2. have been produced at least 21 days before shipping and during that period no case of foot-and-mouth 
disease has been detected in the Member State of origin;  
6.3. have undergone a single HTST treatment (*);  
6.4. comply with the requirements set out in paragraph 4.  
___________  
(*) HTST = High Temperature Short Time pasteurisation at 72 °C for at least 15 seconds or equivalent 
pasteurisation effect achieving a negative reaction to a phosphatase test in bovine milk.’  
(c) Part B is amended as follows:  
(i) paragraph 1.1 is replaced by the following:  
‘1.1. they come from third countries appearing on the list in Part I(A) of Annex XI;’;  
(ii) paragraph 2 is replaced by the following:  
‘2. By way of derogation from paragraph 1.4, Member States shall authorise imports of milk and milk 
products from third countries so authorised in Column “A” of Annex I to Commission Decision 
2004/438/EC (*) provided that the milk and milk products have undergone a single HTST treatment and:  
(a) have not been shipped before a period of at least 21 days has elapsed after production and during that 
period no case of foot-and-mouth disease has been detected in the exporting third country; or  
(b) have been presented at an EU border inspection post at least 21 days after production and during that 
period no case of foot-and-mouth disease has been detected in the exporting third country.  
___________  
(*) OJ L 154, 30.4.2004, p. 72.’;EN L 237/4 Official Journal of the European Union 8.9.2010(iii) the following paragraph 2a is inserted:  
‘2a. Member States shall authorise imports of colostrum or colostrum products of bovine animals provided that:  
2a.1. they come from a third country appearing on the list in Part I(B) of Annex XI;  
2a.2. they comply with the conditions set out in paragraphs 1.2 and 1.3;  
2a.3. they have undergone a single HTST treatment (*) and:  
(a) have not been shipped before a period of at least 21 days has elapsed after production and during that 
period no case of foot-and-mouth disease has been detected in the exporting third country; or  
(b) have been presented at an EU border inspection post at least 21 days after production and during that 
period no case of foot-and-mouth disease has been detected in the exporting third country;  
2a.4. they have been obtained from bovine animals subject to regular veterinary inspections to ensure that 
animals come from holdings on which all bovine herds are:  
(a) either recognised as officially tuberculosis free and officially brucellosis free as defined in Article 2(2)(d) 
and (f) of Directive 64/432/EEC or not restricted under the national legislation of the third country of 
origin of the colostrum regarding eradication of tuberculosis and brucellosis; and  
(b) either recognised as official enzootic-bovine-leukosis-free as defined in Article 2(2)(j) of Directive 
64/432/EEC or included in an official system for the control of enzootic-bovine-leukosis and there 
has been no evidence as a result of clinical and laboratory testing of this disease in the herd during the 
past two years;  
2a.5. after completion of the processing, every precaution has been taken to prevent contamination of the 
colostrum or colostrum products;  
2a.6. the final product has been labelled so as to indicate that it contains Category 3 material and is not intended 
for human consumption, and that it has been:  
(a) packed in new containers; or  
(b) transported in bulk in containers or other means of transport that before use were thoroughly cleansed 
and disinfected using a disinfectant approved for the purpose by the competent authority.  
___________  
(*) HTST = High Temperature Short Time pasteurisation at 72 °C for at least 15 seconds or equivalent pasteur ­
isation effect achieving a negative reaction to a phosphatase test in bovine milk.’;EN 8.9.2010 Official Journal of the European Union L 237/52. in Annex X, Chapter 2 is replaced by the following:  
‘CHAPTER 2  
Health certificate  
For milk, milk products, colostrum and colostrum products not intended for human consumption for dispatch to or transit through  (*) 
the European Union
EN L 237/6 Official Journal of the European Union 8.9.2010  
(*) Delete as appropriate.EN 8.9.2010 Official Journal of the European Union L 237/7EN L 237/8 Official Journal of the European Union 8.9.20103. Annex XI is amended as follows:  
(a) Part I is replaced by the following:  
‘PART I  
List of third countries from which Member States may authorise imports of milk, milk products, colostrum and 
colostrum products (health certificate Chapter 2)  
A. Milk and milk products:  
Third countries listed as authorised in any of the columns of Annex I to Decision 2004/438/EC.  
B. Colostrum and colostrum products:  
Third countries listed as authorised in column “A” of Annex I to Decision 2004/438/EC.’;  
(b) Part XII is replaced by the following:  
‘PART XII  
List of third countries from which Member States may authorise imports of apiculture products (health 
certificate Chapter 13)  
Third countries listed in part 1 of Annex II to Regulation (EU) No 206/2010, and the following country:  
— “(CM) Cameroon” ’.EN 8.9.2010 Official Journal of the European Union L 237/9