II 
(Non-legislative acts)  
REGULATIONS  
COMMISSION REGULATION (EU) No 28/2012  
of 11 January 2012  
laying down requirements for the certification for imports into and transit through the Union of 
certain composite products and amending Decision 2007/275/EC and Regulation (EC) No 1162/2009  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European 
Union,  
Having regard to Council Directive 97/78/EC of 18 December 
1997 laying down the principles governing the organisation of 
veterinary checks on products entering the Community from 
third countries (  1 ), and in particular Article 3(5) thereof;  
Having regard to Council Directive 2002/99/EC of 
16 December 2002 laying down the animal health rules 
governing the production, processing, distribution and intro ­
duction of products of animal origin for human 
consumption (  2 ), and in particular Article 8(5) thereof,  
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 (  3 ), and in 
particular the first paragraph of Article 9 thereof,  
Having regard to Regulation (EC) No 854/2004 of the European 
Parliament and the Council of 29 April 2004 laying down 
specific rules for the organisation of official controls on 
products of animal origin intended for human consumption (  4 ), 
and in particular the first paragraph of Article 16 thereof,  
Having regard to Regulation (EC) No 882/2004 (  5 ) of the 
European Parliament and of the Council of 29 April 2004 on 
official controls performed to ensure the verification of 
compliance with feed and food law, animal health and animal 
welfare rules and in particular Article 48(1) and the first 
subparagraph of Article 63(1) thereof,  Whereas:  
(1) Directive 97/78/EC provides that veterinary checks on 
products from third countries introduced into the 
Union are to be carried out by Member States in 
accordance with that Directive and with Regulation 
(EC) No 882/2004.  
(2) Regulation (EC) No 882/2004 lays down general rules 
for the performance of official controls to verify 
compliance with rules aiming, in particular, at 
preventing, eliminating or reducing to acceptable levels 
risks to humans and animals, either directly or through 
the environment.  
(3) Directive 2002/99/EC lays down the general animal 
health rules governing all stages of the production, 
processing and distribution within the Union and the 
introduction from third countries of products of animal 
origin and products obtained intended for human 
consumption.  
(4) Regulation (EC) No 853/2004 lays down specific rules 
on the hygiene of food of animal origin for food 
business operators. Article 6(4) of that Regulation 
provides that food business operators importing food 
containing both products of plant origin and processed 
products of animal origin (composite products) are to 
ensure that the processed products of animal origin 
contained in such food satisfy certain public health 
requirements laid down therein. In addition, Regulation 
(EC) No 853/2004 provides that food business operators 
must be able to demonstrate that they have done so, for 
example through appropriate documentation or certifi ­
cation.  
(5) Regulation (EC) No 853/2004 applies from 1 January 
2006. However, the application of a number of 
measures laid down therein with immediate effect from 
that date would have presented practical difficulties in 
certain cases.EN 14.1.2012 Official Journal of the European Union L 12/1  
( 1 ) OJ L 24, 30.1.1998, p. 9.  
( 2 ) OJ L 18, 23.1.2003, p. 11.  
( 3 ) OJ L 139, 30.4.2004, p. 55.  
( 4 ) OJ L 139, 30.4.2004, p. 206.  
( 5 ) OJ L 165, 30.4.2004, p. 1.(6) Commission Regulation (EC) No 2076/2005 (  1 ) therefore 
provided that, by way of derogation from Article 6(4) of 
Regulation (EC) No 853/2004, food business operators 
importing food containing composite products were to 
be exempt from the obligation provided for in that 
Article.  
(7) Commission Regulation (EC) No 1162/2009 of 
30 November 2009 laying down transitional measures 
for the implementation of Regulations (EC) No 
853/2004, (EC) No 854/2004 and (EC) No 882/2004 
of the European Parliament and of the Council (  2 ) 
repealed and replaced Regulation (EC) No 2076/2005. 
Regulation (EC) No 1162/2009 contains the same dero ­
gation from Article 6(4) of Regulation (EC) No 853/2004 
as did Regulation (EC) No 2076/2005.  
(8) In addition, Regulation (EC) No 1162/2009 provides that 
imports of composite products are to comply with the 
harmonised Union rules, where applicable, and with the 
national rules implemented by the Member States in 
other cases.  
(9) Regulation (EC) No 1162/2009 applies until 31 
December 2013.  
(10) Commission Decision 2007/275/EC of 17 April 2007 
concerning lists of animals and products to be subject 
to controls at border inspection posts under Council 
Directives 91/496/EEC and 97/78/EC (  3 ) provides that 
certain composite products are to be subject to veterinary 
checks, when imported into the Union. Pursuant to that 
Decision, the composite products subjected to veterinary 
checks are all those containing processed meat products, 
those containing half or more of their substance of any 
one processed product of animal origin other than 
processed meat products and those containing no 
processed meat products and less than half of their 
substance of processed milk product where the final 
products do not meet certain requirements laid down 
in Decision 2007/275/EC.  
(11) In addition, Decision 2007/275/EC lays down certain 
certification requirements regarding the composite 
products subject to veterinary checks. It provides that 
composite products containing processed meat products 
are to be accompanied at introduction into the Union by 
the relevant certificate for meat products laid down in 
Union legislation. Composite products containing 
processed milk products, which are to be subjected to 
veterinary checks, are to be accompanied at introduction 
into the Union by the relevant certificate laid down in 
Union legislation. In addition, composite products 
containing only processed fishery or egg products 
which are to be subjected to veterinary checks are to 
be accompanied at introduction into the Union by the relevant certificate laid down in Union legislation or a 
commercial document where there is no certificate so 
required.  
(12) The composite products subjected to veterinary checks 
pursuant to Decision 2007/275/EC are, by their very 
nature, the ones that may present also a higher public 
health risk. The levels of potential public health risk vary 
depending on the product of animal origin which is 
included in the composite product, the percentage in 
which that product of animal origin is present in the 
composite product and the treatments applied to it as 
well as the shelf stability of the composite product.  
(13) It is therefore appropriate that the public health 
requirements laid down in Regulation (EC) No 
853/2004 apply to those composite products even 
before the expiry of the derogation provided for in Regu ­
lation (EC) No 1162/2009.  
(14) In particular, the certification of compliance with public 
health requirements as laid down in Regulation (EC) No 
853/2004 should be provided for in this Regulation for 
the importation of the composite products containing 
processed meat products, of those composite products 
containing half or more of their substance of milk 
products or of processed fishery or egg products and 
of those composite products containing no processed 
meat products and less than half of their substance of 
processed milk products where the final products are not 
shelf-stable at ambient temperature or where they have 
not clearly undergone in their manufacture a complete 
cooking or heat treatment process throughout their 
substance, so that any raw product is not denatured.  
(15) As a consequence, the derogation laid down in Regu ­
lation (EC) No 1162/2009 should no longer apply for 
those composite products.  
(16) The animal health requirements concerning those 
composite products are already laid down in Union legis ­
lation. Pursuant to those requirements, those composite 
products should in particular only be imported from 
approved third countries.  
(17) A specific model health certificate attesting that such 
composite products imported into the Union comply 
with those public and animal health requirements 
should be laid down in this Regulation. As a conse ­
quence, the certification requirements laid down in 
Decision 2007/275/EC should no longer apply for 
those composite products.  
(18) For the other composite products containing half or 
more of their substance of products of animal origin 
other than milk products or fishery or egg products, 
the certification requirements laid down in Decision 
2007/275/EC should continue to apply. However, for 
reasons of simplification and clarity of Union legislation,EN L 12/2 Official Journal of the European Union 14.1.2012  
( 1 ) OJ L 338, 22.12.2005, p. 83.  
( 2 ) OJ L 314, 1.12.2009, p. 10.  
( 3 ) OJ L 116, 4.5.2007, p. 9.it is appropriate to include those certification 
requirements in this Regulation, so that the main rules 
on the certification of composite products be laid down 
in only one act.  
(19) Decision 2007/275/EC and Regulation (EC) No 
1162/2009 should therefore be amended accordingly.  
(20) Due to animal health reasons, a certificate and specific 
conditions for transit via the Union should be provided 
for. However these conditions should be applicable only 
to composite products containing processed meat 
products or processed dairy products.  
(21) Specific conditions for transit via the Union of 
consignments to and from Russia should be provided 
for, owing to the geographical situation of Kaliningrad, 
which only concerns Latvia, Lithuania and Poland.  
(22) To avoid any disruption of trade, the use of certificates 
issued in accordance with Decision 2007/275/EC prior 
to the date of application of this Regulation should be 
authorised for a transitional period.  
(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  
Subject matter  
This Regulation lays down rules on the certification of 
consignments of certain composite products introduced into 
the Union from third countries.  
Article 2  
Definitions  
For the purposes of this Regulation, the definitions in Article 2 
of Decision 2007/275/EC shall apply.  
Article 3  
Imports of certain composite products  
1. Consignments of the following composite products 
introduced into the Union shall come from a third country 
or part thereof authorised for the introduction into the Union 
of consignments of the products of animal origin contained in 
those composite products and the products of animal origin 
used for the production of such composite products shall 
originate from establishments in compliance with 
Article 6.1(b) of Regulation (EC) No 853/2004:  
(a) composite products containing processed meat products, as 
referred to in Article 4(a) of Decision 2007/275/EC;  
(b) composite products containing processed milk products and 
covered by Article 4(b) and (c) of Decision 2007/275/EC;  (c) composite products containing half or more of their 
substance of processed fishery or egg products and 
covered by Article 4(b) of Decision 2007/275/EC.  
2. Consignments of composite products referred to in 
paragraph 1 shall be accompanied by a health certificate in 
accordance with the model health certificate set out in Annex 
I and comply with the conditions established in such 
certificates.  
3. Consignments of composite products containing half or 
more of their substance of products of animal origin other than 
those referred to in paragraph 1 shall come from a third 
country or part thereof authorised for the introduction into 
the Union of consignments of the products of animal origin 
contained in those composite products and shall be accom ­
panied at introduction into the Union by the relevant certificate 
laid down in Union legislation for those products of animal 
origin or by a commercial document where there is no 
certificate so required.  
Article 4  
Transit and storage of certain composite products  
The introduction into the Union of consignments of composite 
products referred to in Article 3(1)(a) and (b) not intended for 
importation into the Union but destined for a third country 
either by immediate transit or after storage in the Union, in 
accordance with Articles 11, 12 or 13 of Council Directive 
97/78/EC, shall only be authorised if the consignments 
comply with the following conditions:  
(a) they come from a third country or part thereof authorised 
for the introduction into the Union of consignments of the 
products of animal origin contained in those composite 
products and comply with the appropriate treatment 
conditions for such products, as provided for in 
Commission Decision 2007/777/EC (  1 ) and Commission 
Regulation (EU) No 605/2010 (  2 ) for the product of 
animal origin concerned;  
(b) they are accompanied by a health certificate drawn up in 
accordance with the model health certificate set out in 
Annex II;  
(c) they comply with the specific animal health requirements 
for the importation into the Union of the products of 
animal origin contained in the composite products 
concerned, as set out in the animal health attestation in 
the model health certificate referred to in point (b);  
(d) they are certified as acceptable for transit, including for 
storage as appropriate, on the common veterinary entry 
document referred to in Article 2(1) of Commission Regu ­
lation (EC) No 136/2004 (  3 ), signed by the official 
veterinarian of the border inspection post of introduction 
into the Union.EN 14.1.2012 Official Journal of the European Union L 12/3  
( 1 ) OJ L 312, 30.11.2007, p. 49.  
( 2 ) OJ L 175, 10.7.2010, p. 1.  
( 3 ) OJ L 21, 28.1.2004, p. 11.Article 5  
Derogation for transit of consignments coming from and 
destined to Russia  
1. By way of derogation from Article 4, the transit by road 
or by rail through the Union, between designated border 
inspection posts in Latvia, Lithuania and Poland, listed in 
Commission Decision 2009/821/EC (  1 ), of consignments of 
composite products referred to Article 3 coming from and 
destined to Russia directly or via another third country shall 
be authorised provided that the following conditions are 
complied with:  
(a) the consignment is sealed with a serially numbered seal at 
the border inspection post of introduction into the Union 
by the veterinary services of the competent authority;  
(b) the documents accompanying the consignment and referred 
to in Article 7 of Directive 97/78/EC are stamped ‘ONLY 
FOR TRANSIT TO RUSSIA VIA THE EU’ on each page by 
the official veterinarian of the competent authority 
responsible for the border inspection post of introduction 
into the Union;  
(c) the procedural requirements provided for in Article 11 of 
Directive 97/78/EC are complied with;  
(d) the consignment is certified as acceptable for transit on the 
common veterinary entry document by the official 
veterinarian of the border inspection post of introduction 
into the Union.  
2. Unloading or storage, as defined in Article 12(4) or in 
Article 13 of Directive 97/78/EC, of such consignments on 
Union territory shall not be allowed.  
3. Regular audits shall be made by the competent authority 
to ensure that the number of consignments and the quantities 
of products leaving the Union territory matches the number and 
quantities entering the Union.  Article 6  
Amendment to Decision 2007/275/EC  
Article 5 of Decision 2007/275/EC is deleted.  
Article 7  
Amendment to Regulation (EC) No 1162/2009  
In Regulation (EC) No 1162/2009, the first subparagraph of 
Article 3(2) is replaced by the following:  
‘2. By way of derogation from Article 6(4) of Regulation 
(EC) No 853/2004, food business operators importing food 
containing both products of plant origin and processed 
products of animal origin, other than those referred to in 
Article 3(1) of Regulation (EU) No 28/2012 (*), shall be 
exempt from the obligation provided for in that Article.  
___________  
(*) OJ L 12, 14.1.2012, p. 1.’  
Article 8  
Transitional provision  
For a transitional period until 30 September 2012, 
consignments of composite products in respect of which the 
relevant certificates have been issued in accordance with 
Article 5 of Decision 2007/275/EC before 1 March 2012 
may continue to be introduced into the Union.  
Article 9  
Entry into force and application  
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 March 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 L 12/4 Official Journal of the European Union 14.1.2012  
( 1 ) OJ L 296, 12.11.2009, p. 1.ANNEX I  
Model Health Certificate for import into the European Union of composite products intended for human 
consumption
EN 14.1.2012 Official Journal of the European Union L 12/5EN L 12/6 Official Journal of the European Union 14.1.2012EN 14.1.2012 Official Journal of the European Union L 12/7EN L 12/8 Official Journal of the European Union 14.1.2012EN 14.1.2012 Official Journal of the European Union L 12/9EN L 12/10 Official Journal of the European Union 14.1.2012ANNEX II  
Model Health Certificate for transit through or storage in the European Union of composite products intended 
for human consumption
EN 14.1.2012 Official Journal of the European Union L 12/11EN L 12/12 Official Journal of the European Union 14.1.2012EN 14.1.2012 Official Journal of the European Union L 12/13