COMMISSION REGULATION (EU) No 16/2012  
of 11 January 2012  
amending Annex II to Regulation (EC) No 853/2004 of the European Parliament and of the Council 
as regards the requirements concerning frozen food 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 origin (  1 ), and in 
particular Article 10(1) thereof,  
Whereas:  
(1) Regulation (EC) No 853/2004 lays down rules on the 
hygiene of food of animal origin for food business 
operators. Food business operators are required to 
comply with the requirements set out in Annex II 
thereto.  
(2) Experience gained since the date of application of Regu ­
lation (EC) No 853/2004 has exposed certain difficulties 
as regards the storage of food of animal origin. If the 
date of initial freezing of such food was indicated, food 
business operators would be better able to judge the 
suitability of the food for human consumption.  
(3) Directive 2000/13/EC of the European Parliament and of 
the Council of 20 March 2000 on the approximation of 
the laws of the Member States relating to the labelling, 
presentation and advertising of foodstuffs (  2 ) concerns the 
labelling of foodstuffs to be delivered as such to the final 
consumer and certain aspects relating to the presentation 
and advertising thereof. However, that Directive does not 
apply to prior stages of food production.  (4) In addition, the enforcement of compliance with the 
provisions of Regulation (EC) No 853/2004 by the 
competent authorities has revealed that more detailed 
requirements regarding the production and freezing of 
food of animal origin in the stages of production prior 
to its delivery as such to the final consumer are 
necessary.  
(5) Accordingly, Annex II to Regulation (EC) No 853/2004 
should be amended in order to include requirements 
applicable to frozen food of animal origin.  
(6) Regulation (EC) No 853/2004 should therefore be 
amended accordingly.  
(7) 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  
Annex II to Regulation (EC) No 853/2004 is amended in 
accordance with the Annex to this Regulation.  
Article 2  
This Regulation shall enter into force on the 20th day following 
its publication in the  Official Journal of the European Union . 
It shall apply from 1 July 2012.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels, 11 January 2012.  
For the Commission  
The President  
José Manuel BARROSOEN 12.1.2012 Official Journal of the European Union L 8/29  
( 1 ) OJ L 139, 30.4.2004, p. 55.  
( 2 ) OJ L 109, 6.5.2000, p. 29.ANNEX  
The following Section IV is added to Annex II to Regulation (EC) No 853/2004:  
‘SECTION IV: REQUIREMENTS APPLICABLE TO FROZEN FOOD OF ANIMAL ORIGIN  
1. For the purposes of this Section, “date of production” means:  
(a) the date of slaughter in the case of carcasses, half carcasses or quarter carcases;  
(b) the date of killing in the case of bodies of wild game;  
(c) the date of harvesting or catching, in the case of fishery products;  
(d) the date of processing, cutting, mincing or preparation, as appropriate, for any other food of animal origin.  
2. Until the stage at which a food is labelled in accordance with Directive 2000/13/EC or used for further 
processing, food business operators must ensure that in the case of frozen food of animal origin intended for 
human consumption, the following information is made available to the food business operator to whom the 
food is supplied and, upon request, to the competent authority:  
(a) the date of production; and  
(b) the date of freezing, if different from the date of production.  
Where a food is made from a batch of raw materials with different dates of production and of freezing, the oldest 
dates of production and/or of freezing, as appropriate, must be made available.  
3. The appropriate form in which the information must be made available is up to the choice of the supplier of the 
frozen food, as long as the information requested in paragraph 2 will be clearly and unequivocally available to 
and retrievable by the business operator to whom the food is supplied.’EN L 8/30 Official Journal of the European Union 12.1.2012