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14.1.2012 Official
Journal
of
the
European
Union
L
12/1
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,
Whereas:
Having regard to the Treaty on the Functioning of the European
(1) Directive
97/78/EC
provides
that
veterinary
checks
on
Union,
products from third countries introduced into the
Union are to be carried out by Member States in
accordance with that Directive and with Regulation
Having regard to Council Directive 97/78/EC of 18 December
(EC) No 882/2004.
1997 laying down the principles governing the organisation of
veterinary checks on products entering the Community from
third countries (
(2) Regulation
(EC)
No
882/2004
lays
down
general
rules

1 ), and in particular Article 3(5) thereof;
for the performance of official controls to verify
compliance with rules aiming, in particular, at
preventing, eliminating or reducing to acceptable levels
Having regard to Council Directive 2002/99/EC of
risks to humans and animals, either directly or through
16 December 2002 laying down the animal health rules
the environment.
governing the production, processing, distribution and intro
duction of products of animal origin for human
consumption ( 2 ), and in particular Article 8(5) thereof,
(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
Having regard to Regulation (EC) No 853/2004 of the European
introduction from third countries of products of animal
Parliament and of the Council of 29 April 2004 laying down
origin and products obtained intended for human
specific hygiene rules for food of animal origin ( 3 ), and in
consumption.
particular the first paragraph of Article 9 thereof,
(4) Regulation
(EC)
No
853/2004
lays
down
specific
rules
Having regard to Regulation (EC) No 854/2004 of the European
on the hygiene of food of animal origin for food
Parliament and the Council of 29 April 2004 laying down
business operators. Article 6(4) of that Regulation
specific rules for the organisation of official controls on
provides that food business operators importing food
products of animal origin intended for human consumption ( 4 ),
containing both products of plant origin and processed
and in particular the first paragraph of Article 16 thereof,
products of animal origin (composite products) are to
ensure that the processed products of animal origin
contained in such food satisfy certain public health
Having regard to Regulation (EC) No 882/2004 (
requirements laid down therein. In addition, Regulation

5 ) of the
European Parliament and of the Council of 29 April 2004 on
(EC) No 853/2004 provides that food business operators
official controls performed to ensure the verification of
must be able to demonstrate that they have done so, for
compliance with feed and food law, animal health and animal
example through appropriate documentation or certifi
welfare rules and in particular Article 48(1) and the first
cation.
subparagraph of Article 63(1) thereof,
(5) Regulation
(EC)
No
853/2004
applies
from
1
January
( 1 ) OJ L 24, 30.1.1998, p. 9.
2006. However, the application of a number of
( 2 ) OJ L 18, 23.1.2003, p. 11.
measures laid down therein with immediate effect from
( 3 ) OJ L 139, 30.4.2004, p. 55.
( 4 ) OJ L 139, 30.4.2004, p. 206.
that date would have presented practical difficulties in
( 5 ) OJ L 165, 30.4.2004, p. 1.
certain cases.

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L 12/2
EN
Official Journal of the European Union
14.1.2012
(6) Commission
Regulation
(EC)
No
2076/2005
( 1 ) therefore
relevant certificate laid down in Union legislation or a
provided that, by way of derogation from Article 6(4) of
commercial document where there is no certificate so
Regulation (EC) No 853/2004, food business operators
required.
importing food containing composite products were to
be exempt from the obligation provided for in that
Article.
(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
(7) Commission
Regulation
(EC)
No
1162/2009 of
health risk. The levels of potential public health risk vary
30 November 2009 laying down transitional measures
depending on the product of animal origin which is
for the implementation of Regulations (EC) No
included in the composite product, the percentage in
853/2004, (EC) No 854/2004 and (EC) No 882/2004
which that product of animal origin is present in the
of the European Parliament and of the Council (
composite product and the treatments applied to it as

2 )
repealed and replaced Regulation (EC) No 2076/2005.
well as the shelf stability of the composite product.
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.
(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
(8) In
addition,
Regulation
(EC)
No
1162/2009
provides
that
imports of composite products are to comply with the
lation (EC) No 1162/2009.
harmonised Union rules, where applicable, and with the
national rules implemented by the Member States in
other cases.
(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
(9) Regulation
(EC)
No
1162/2009
applies
until
31
processed meat products, of those composite products
December 2013.
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
(10) Commission
Decision
2007/275/EC
of
17
April
2007
meat products and less than half of their substance of
concerning lists of animals and products to be subject
processed milk products where the final products are not
to controls at border inspection posts under Council
shelf-stable at ambient temperature or where they have
Directives 91/496/EEC and 97/78/EC ( 3 ) provides that
not clearly undergone in their manufacture a complete
certain composite products are to be subject to veterinary
cooking or heat treatment process throughout their
checks, when imported into the Union. Pursuant to that
substance, so that any raw product is not denatured.
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
(15) As
a
consequence,
the
derogation
laid
down
in
Regu
one processed product of animal origin other than
lation (EC) No 1162/2009 should no longer apply for
processed meat products and those containing no
those composite products.
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
(16) The animal health requirements concerning those
in Decision 2007/275/EC.
composite products are already laid down in Union legis
lation. Pursuant to those requirements, those composite
products should in particular only be imported from
(11) In
addition,
Decision
2007/275/EC
lays
down
certain
approved third countries.
certification requirements regarding the composite
products subject to veterinary checks. It provides that
composite products containing processed meat products
(17) A
specific
model
health
certificate
attesting
that
such
are to be accompanied at introduction into the Union by
composite products imported into the Union comply
the relevant certificate for meat products laid down in
with those public and animal health requirements
Union legislation. Composite products containing
should be laid down in this Regulation. As a conse
processed milk products, which are to be subjected to
quence, the certification requirements laid down in
veterinary checks, are to be accompanied at introduction
Decision 2007/275/EC should no longer apply for
into the Union by the relevant certificate laid down in
those composite products.
Union legislation. In addition, composite products
containing only processed fishery or egg products
which are to be subjected to veterinary checks are to
(18) For
the
other
composite
products
containing
half
or
be accompanied at introduction into the Union by the
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
( 1 ) OJ L 338, 22.12.2005, p. 83.
( 2 ) OJ L 314, 1.12.2009, p. 10.
2007/275/EC should continue to apply. However, for
( 3 ) OJ L 116, 4.5.2007, p. 9.
reasons of simplification and clarity of Union legislation,

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EN
14.1.2012 Official
Journal
of
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European
Union
L
12/3
it is appropriate to include those certification
(c) composite products containing half or more of their
requirements in this Regulation, so that the main rules
substance of processed fishery or egg products and
on the certification of composite products be laid down
covered by Article 4(b) of Decision 2007/275/EC.
in only one act.
2. Consignments
of
composite
products
referred
to
in
(19) Decision 2007/275/EC and Regulation (EC) No
paragraph 1 shall be accompanied by a health certificate in
1162/2009 should therefore be amended accordingly.
accordance with the model health certificate set out in Annex
I and comply with the conditions established in such
(20) Due to animal health reasons, a certificate and specific
certificates.
conditions for transit via the Union should be provided
for. However these conditions should be applicable only
to composite products containing processed meat
3. Consignments
of
composite
products
containing
half
or
products or processed dairy products.
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
(21) Specific conditions for transit via the Union of
the Union of consignments of the products of animal origin
consignments to and from Russia should be provided
contained in those composite products and shall be accom
for, owing to the geographical situation of Kaliningrad,
panied at introduction into the Union by the relevant certificate
which only concerns Latvia, Lithuania and Poland.
laid down in Union legislation for those products of animal
origin or by a commercial document where there is no
certificate so required.
(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
Article 4
authorised for a transitional period.
Transit and storage of certain composite products
(23) The
measures
provided
for
in
this
Regulation
are
in
The introduction into the Union of consignments of composite
accordance with the opinion of the Standing
products referred to in Article 3(1)(a) and (b) not intended for
Committee on the Food Chain and Animal Health,
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
HAS ADOPTED THIS REGULATION:
97/78/EC, shall only be authorised if the consignments
comply with the following conditions:
Article 1
Subject matter
(a) they come from a third country or part thereof authorised
for the introduction into the Union of consignments of the
This Regulation lays down rules on the certification of
products of animal origin contained in those composite
consignments of certain composite products introduced into
products and comply with the appropriate treatment
the Union from third countries.
conditions for such products, as provided for in
Commission Decision 2007/777/EC ( 1 ) and Commission
Article 2
Regulation (EU) No 605/2010 ( 2 ) for the product of
animal origin concerned;
Definitions
For the purposes of this Regulation, the definitions in Article 2
(b) they are accompanied by a health certificate drawn up in
of Decision 2007/275/EC shall apply.
accordance with the model health certificate set out in
Annex II;
Article 3
Imports of certain composite products
(c) they comply with the specific animal health requirements
for the importation into the Union of the products of
1. Consignments
of
the
following
composite
products
animal origin contained in the composite products
introduced into the Union shall come from a third country
concerned, as set out in the animal health attestation in
or part thereof authorised for the introduction into the Union
the model health certificate referred to in point (b);
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
(d) they are certified as acceptable for transit, including for
originate from establishments in compliance with
storage as appropriate, on the common veterinary entry
Article 6.1(b) of Regulation (EC) No 853/2004:
document referred to in Article 2(1) of Commission Regu
lation (EC) No 136/2004
( 3 ), signed by the official
(a) composite products containing processed meat products, as
veterinarian of the border inspection post of introduction
referred to in Article 4(a) of Decision 2007/275/EC;
into the Union.
( 1 ) OJ L 312, 30.11.2007, p. 49.
(b) composite products containing processed milk products and
( 2 ) OJ L 175, 10.7.2010, p. 1.
covered by Article 4(b) and (c) of Decision 2007/275/EC;
( 3 ) OJ L 21, 28.1.2004, p. 11.

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Official Journal of the European Union
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Article 5
Article 6
Derogation for transit of consignments coming from and
Amendment to Decision 2007/275/EC
destined to Russia
Article 5 of Decision 2007/275/EC is deleted.
1. By
way
of
derogation
from
Article
4,
the
transit
by
road
or by rail through the Union, between designated border
Article 7
inspection posts in Latvia, Lithuania and Poland, listed in
Commission Decision 2009/821/EC ( 1 ), of consignments of
Amendment to Regulation (EC) No 1162/2009
composite products referred to Article 3 coming from and
destined to Russia directly or via another third country shall
In Regulation (EC) No 1162/2009, the first subparagraph of
be authorised provided that the following conditions are
Article 3(2) is replaced by the following:
complied with:
‘2. By way of derogation from Article 6(4) of Regulation
(a) the consignment is sealed with a serially numbered seal at
(EC) No 853/2004, food business operators importing food
the border inspection post of introduction into the Union
containing both products of plant origin and processed
by the veterinary services of the competent authority;
products of animal origin, other than those referred to in
Article 3(1) of Regulation (EU) No 28/2012 (*), shall be
(b) the documents accompanying the consignment and referred
exempt from the obligation provided for in that Article.
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
(*) OJ L 12, 14.1.2012, p. 1.’
responsible for the border inspection post of introduction
into the Union;
Article 8
(c) the procedural requirements provided for in Article 11 of
Directive 97/78/EC are complied with;
Transitional provision
For a transitional period until 30 September 2012,
(d) the consignment is certified as acceptable for transit on the
consignments of composite products in respect of which the
common veterinary entry document by the official
relevant certificates have been issued in accordance with
veterinarian of the border inspection post of introduction
Article 5 of Decision 2007/275/EC before 1 March 2012
into the Union.
may continue to be introduced 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
Article 9
Union territory shall not be allowed.
Entry into force and application
3. Regular
audits
shall
be
made
by
the
competent
authority This Regulation shall enter into force on the 20th day following
to ensure that the number of consignments and the quantities
its publication in the Official Journal of the European Union.
of products leaving the Union territory matches the number and
quantities entering the 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 BARROSO
( 1 ) OJ L 296, 12.11.2009, p. 1.

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12/5
ANNEX I
Model Health Certificate for import into the European Union of composite products intended for human
consumption

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ANNEX II
Model Health Certificate for transit through or storage in the European Union of composite products intended
for human consumption

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Official Journal of the European Union
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