Corrigendum to Commission Decision 2004/238/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 (OJ L 154, 30.4.2004)
Date: 2004-05-27
Institutions: European Commission
Subjects: health certificate, health control, health legislation, human nutrition, import, milk, milk product

27.5.2004

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Official Journal of the European Union

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Corrigendum to Commission Decision 2004/238/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

(Official Journal of the European Union L 154 of 30 April 2004)

Decision 2004/238/EC should read as follows:

COMMISSION DECISION

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

(notified under document number C(2004) 1691)

(Text with EEA relevance)

(2004/438/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Com-
munity,

Having regard to Council Directive 92/46/EEC of 16 June 1992
laying down the health rules for the production and placing on
the market of raw milk, heat-treated milk and milk-based
products (1), and in particular Article 23(2)(b) and (3)(a), (c) and
(d) 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 introduction of
products of animal origin for human consumption (2), and in
particular Article 8(1) and (4) and Article 9(4)(a) and (c)
thereof,

Whereas:

(1)

(2)

Directive 92/46/EEC of 16 June 1992 lays down the
health rules for the production and placing on the
market of raw milk, heat-treated milk and milk-based
products, including for imports.

Directive 2002/99/EC lays down the animal health rules
governing the production, processing, distribution and
introduction of products of animal origin for human
consumption.

(1) OJ L 268, 14.9.1992 p. 1; Directive as last amended by Regulation

(EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).

(2) OJ L 18, 23.1.2003, p. 11.

(3)

(4)

(5)

(6)

(7)

Commission Decision 95/340/EC (3) draws up a provi-
sional list of third countries from which Member States
authorize imports of milk and milk-based products.

Commission Decision 95/342/EC (4) lays down the treat-
ment to be applied to milk and milk-based products for
human consumption from third countries or parts of
third countries where there is a risk of foot-and-mouth
disease. Its provisions should be updated to take account
the foot-and-mouth virus
of
provided for in Council Directive 2003/85/EC (5) laying
down Community measures for the control of foot-and-
mouth disease.

the treatment against

Commission Decision 95/343/EC (6)
lays down animal
health conditions and veterinary certificates
the
importation from certain third countries of heat-treated
milk, milk-based products and raw milk for human
consumption.

for

In the interest of clarity and rationality Decisions
95/340/EC, 95/342/EC and 95/343/EC should be
repealed and replaced by this Decision.

Provision should however be made to make it possible
to use the format of the certificates laid down in Deci-
sions 95/343/EC for an interim period of time.

(3) OJ L 200, 24.8.1995 p. 38; Decision as last amended by Decision

2003/58/EC (OJ L 23, 28.1.2003, p. 26).

(4) OJ L 200, 24.8.1995 p. 50.
(5) OJ L 306, 22.11.2003 p. 1.
(6) OJ L 200, 24.8.1995 p. 52. Decision as last amended by Decision

97/115/EC (OJ L 42, 13.2.1997 p. 16).

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Council Directive 97/78/EC (1) lays down the principles
governing the organisation of veterinary checks on
products entering the Community from third countries
and certain provisions for transit are already provided
for in Article 11 such as the use of ANIMO messages
and of the common veterinary entry document.

is appropriate to specify the border inspection posts
designated for the control of such transits taking into
account this Decision.

(15)

The measures provided for in this Decision are in
accordance with the opinion of the Standing Committee
on the Food Chain and Animal Health,

(8)

(9)

(10)

(11)

However, it is necessary in order to safeguard the disease
situation in the Community to further ensure that
consignments of milk transiting through the Com-
munity, comply with the animal health import condi-
tions applicable for authorised countries.

Council Decision 79/542/EEC 21 December 1976
drawing up a list of third countries or parts of third
countries, and laying down animal and public health,
and veterinary certification conditions for the importa-
tion into the Community of certain live animals and
their
recently been amended to
include general transit conditions and a derogation for
transit between Russia with a reference to the specific
border
latter
purpose.

inspection posts designated for

fresh meat (2), has

this

In the light of experience, it appears that the presenta-
tion to the border inspection post, pursuant to Article 7
of Directive 97/78/EC, of the original veterinary docu-
ments established in the exporting third country to fulfil
the regulatory requirement of the third country of desti-
nation, is not sufficient to ensure that the animal health
conditions required for the safe introduction into the
territory of the Community of the products concerned
are effectively satisfied;
is therefore appropriate to
establish a specific model of animal health certificate to
be used in transit situations for the products concerned.

it

(12)

It is further appropriate to clarify the implementation of
the condition laid down in Article 11 of Directive
97/78/EC, that transit is only allowed from third coun-
tries whose products are not prohibited for introduction
in the territory of the Community, by making reference
to the list of third countries annexed to this Decision.

(13) However specific conditions for transits via the Com-
munity of consignments to and from Russia should be
foreseen due to the geographical situation of Kaliningrad
and taking into account climatic problems impeding the
use of some ports at certain times of the year.

(14)

Commission Decision 2001/881/EC (3) draws up a list of
border inspection posts agreed for veterinary checks on
animals and animal products from third countries and it

(1) OJ L 24, 30.1.1998, p. 9. Directive as last amended by the Act
concerning the conditions of Accession (OJ L 236, 23.9.2003, p.
381).

(2) OJ L 146, 14.6.1979, p. 15. Decision as last amended by Commis-

sion Decision 2004/372/EC (OJ L 118, 24.3.2004, p. 21).

(3) OJ L 326, 11.12.2001, p. 44. Decision as last amended by Decision

2004/273/EC (OJ L 86, 24.3.2004, p. 21).

HAS ADOPTED THIS DECISION:

Article 1

Imports into the Community of milk and milk-based products
shall only be allowed if the milk and milk-based products
comply with Articles 2, 3, and 5.

Transit and storage of milk and milk-based products shall only
be allowed if the milk and milk-based products comply with
Articles 4 and 5.

Article 2

1. Member States shall authorise imports of raw milk and
raw milk-based products from third countries so authorised in
column A of the list in Annex I.

2. Member States shall authorise imports of milk and milk-
based products that have undergone:

— a single heat treatment with a heating effect at least equal
to that achieved by a pasteurisation process of at least
72 °C for at least 15 seconds, and

— sufficient to ensure a negative reaction to a phosphatase

test,

from third countries so authorised in column B of the list in
Annex I where there is no threat of foot-and-mouth disease.

3. Member States shall authorise imports of milk and milk-
based products that have undergone either:

(a) a sterilisation process, to achieve an F0 value equal to or

greater than three, or

(b) an ultra high temperature (UHT) treatment at 132 °C for at

least one second, or

(c) a high temperature short time pasteurisation treatment at
72 °C for at least 15 seconds or equivalent pasteurisation
effect achieving a negative reaction to a phosphatase test
(HTST) applied twice to milk with a pH equal to or above
7,0, or

(d) a HTST treatment of milk with a pH below 7,0, or

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(e) a HTST treatment combined with another physical treat-

ment by:

(i) either lowering the pH below 6 for one hour, or

(ii) additional heating to 72 °C or more, combined with

desiccation,

from third countries so authorised in column C of the list in
Annex I where there is a threat of foot-and-mouth disease. The
milk-based products must either undergo one of the above
treatments or be produced from milk treated in accordance
with the treatments laid down above.

Article 3

Consignments of milk and milk-based products from
1.
third countries authorized in accordance with Article 2 shall be
accompanied by, and comply with conditions laid down in, a
health certificate drawn up in accordance with the relevant
model drawn up in Part 2 of Annex II to this Decision, as
follows:

— ‘Milk-RM’ for raw milk intended to be accepted at a collec-
tion centre, standardization centre, treatment establishment
or processing establishment,

— ‘Milk-RMP’ for raw milk products,

— ‘Milk-HTB’

for heat-treated milk, heat-treated milk-based
products and milk-based products made from heat-treated
milk, coming from third countries or parts of third coun-
tries in which there is no threat of foot-and-mouth disease,

— ‘Milk-HTC’

for heat-treated milk, heat-treated milk-based
products and milk-based products made from heat-treated
milk coming from third countries or parts of third countries
foot-and-mouth disease,
in which there is a threat of
however
such
imports (where there is no threat of foot and mouth) may
use this model.

those countries already authorised for

The health certificates shall be completed in accordance

2.
with the notes set out in Part 1 of Annex II.

Article 4

1.
intro-
Consignments of milk and milk-based products,
duced into the territory of the Community and which are
destined for a third country either by transit immediately or
after storage in accordance with Articles 12(4) or 13 of Direc-
tive 97/78/EC, and not intended for importation into the Euro-
pean Community shall comply with the following require-
ments:

(a) they shall come from the territory of a third country or a
to this Decision,
the product

part
according to the treatment
concerned as laid down in Article 2;

thereof authorized in Annex I

required for

3 of Annex II to this Decision, signed by an official veteri-
narian of the competent veterinary services of the third
country concerned;

(d) they are certified as acceptable for transit or storage (as
appropriate) on the Common Veterinary Entry Document
by the Official Veterinarian of the Border Inspection Post of
introduction.

2.

(a) By way of derogation from paragraph 1 above and
Article 5 Member States shall authorise the transit by
road or by rail through the Community, between desig-
nated Community border inspection posts listed in the
Annex to Decision 2001/881/EC, of consignments
coming from and destined to Russia directly or via
another third country provided that the following condi-
tions are met:

(i) the consignment shall be sealed with a serially
numbered seal at
the border inspection post of
entry to the EC by the veterinary services of the
competent authority;

(ii) the documents accompanying the consignment and
referred to in Article 7 of Directive 97/78/EC shall
be stamped ‘ONLY FOR TRANSIT TO RUSSIA VIA
THE EC’ on each page by the official veterinarian of
the competent authority responsible for the border
inspection post;

(iii) the procedural requirements provided for in Article
11 of Directive 97/78/EC shall be complied with;

(iv) 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;

(b) unloading or storage on European Community territory of
such consignments, as defined in Article 12 (4) or Article
13 respectively of Directive 97/78/EC, shall not be allowed;

(c) regular audits shall be made by the competent authority to
ensure that the number of consignments and the quantities
of products leaving the EC territory matches the number
and quantities entering.

Article 5

Milk and milk-based products from authorised third countries
or parts of third countries where an outbreak of foot-and-
mouth disease has occurred within the last 12 months or
which have carried out vaccination against
foot-and-mouth
disease in the last 12 months shall, before they are introduced
into Community territory, undergo one of the treatments listed
in Article 2(3).

(b) they shall meet the specific animal health conditions set out
in section 9 of the corresponding model health certificate
drawn up under Part 2 of Annex II to this Decision;

(c) they shall be accompanied by an animal health certificate
established in accordance with the model laid down in Part

Article 6

Decisions 95/340/EC, 95/342/EC and 95/343/EC are repealed.

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Article 7

The certificates drawn up in the format under Decision
95/343/EC may be used until six months after the date laid
down in paragraph 1 of Article 8 at the latest.

Article 8

1.

This Decision shall apply from 1 May 2004.

Article 4 paragraph 1 and Part 3 of Annex II shall only

2.
apply from 1 January 2005.

References made by Community legislation to the list of
3.
third countries appearing in the Annex to Decision 95/340/EC

shall be construed as references to the list of third countries
appearing in Annex I to this Decision.

This Decision is addressed to the Member States.

Article 9

Done at Brussels, 29 April 2004.

For the Commission

David BYRNE

Member of the Commission

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ANNEX I

‘+’: country is authorised.

‘0’: country is not authorised.

ISO code of third
country

Third country

Column A

Column B

Column C

AD

AL

AN

AR

AU

BG

BR

BW

BY

BZ

BH

CA

CH

CL

CN

CO

CR

CU

DZ

ET

GL

GT

HK

HN

HR

IL

IN

IS

Andorra

Albania

Netherlands Antilles

Argentina

Australia

Bulgaria

Brazil

Botswana

Belarus

Belize

Bosnia-Herzegovina

Canada

Switzerland

Chile

People's Republic of China

Columbia

Costa Rica

Cuba

Algeria

Ethiopia

Greenland

Guatemala

Hong Kong

Honduras

Croatia

Israel

India

Iceland

+

0

0

0

0

0

0

0

0

0

0

+

+

+

0

0

0

0

0

0

0

0

0

0

0

0

0

+

+

0

0

0

+

+

0

0

0

0

0

+

+

+

0

0

0

0

0

0

+

0

0

0

+

0

0

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

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ISO code of third
country

KE

MA

MG

MK( (*))

MR

MU

MX

NA

NI

NZ

PA

PY

RO

RU

SG

SV

SZ

TH

TN

TR

UA

US

UY

ZA

ZW

Third country

Column A

Column B

Column C

Kenya

Morocco

Madagascar

Former Yugoslav Republic of
Macedonia

Mauritania

Mauritius

Mexico

Namibia

Nicaragua

New Zealand

Panama

Paraguay

Romania

Russia

Singapore

El Salvador

Swaziland

Thailand

Tunisia

Turkey

Ukraine

United States of America

Uruguay

South Africa

Zimbabwe

0

0

0

0

0

0

0

0

0

+

0

0

0

0

0

0

0

0

0

0

0

+

0

0

0

0

0

0

+

0

0

0

0

0

+

0

0

+

0

0

0

0

0

0

0

0

+

0

0

0

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

(*) Former Yugoslav Republic of Macedonia; provisional code that does not affect the definitive denomination of the country to be attrib-

uted after the conclusion of the negotiations currently taking place in the United Nations.

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ANNEX II

Part 1

Models of health certificates

‘Milk-RM’

for raw milk from third countries or parts of third countries included in Annex I column A intended to be
accepted at a collection centre, standardization centre, treatment establishment or processing establish-
ment.

‘Milk-RMP’

for raw milk products from third countries or parts of third countries included in Annex I column A.

‘Milk-HTB’

‘Milk-HTC’

for heat-treated milk, heat-treated milk-based products or milk-based products made from heat-treated
milk from third countries or parts of third countries included in Annex I column B.

for heat-treated milk, heat-treated milk-based products or milk-based products made from heat-treated
milk from third countries or parts of third countries included in Annex I column C.

‘Milk-T/S’

for milk and milk-based products, for transit/storage in the European Community.

Notes

(e) When the certificate,

including additional schedules
referred to in (d), comprises more than one page, each
page shall be numbered - (page number) of (total number
of pages) - on its bottom and shall bear the code
number of the certificate that has been designated by
the competent authority on its top.

(f) The original of the certificate must be completed and
signed by a representative of the competent authority
responsible for verifying and certifying that the raw
milk, heat-treated milk or milk-based products meet
the requirements of Directive 92/46/EEC.

(g)

the competent authorities of the exporting country
shall ensure that the principles of certification equiva-
lent to those laid down in Council Directive 96/93/EC
are followed.

(h) The colour of the signature shall be different to that
of the printing. The same rule applies to stamps other
than those embossed or watermark.

to

(a) Health certificates shall be produced by the exporting
country, based on the models appearing in this Annex
II, according to the layout of the model that corre-
sponds
and milk-based products
concerned. They shall contain, in the numbered order
that appears in the model, the attestations that are
required for any third country and, as the case may be,
those supplementary guarantees that are required for
the exporting third country or part thereof.

the milk

(b) The original of each certificate shall consist of a single
page, both sides, or, where more text is required,
it
shall be in such a form that all pages needed are part
of an integrated whole and indivisible.

(c)

(d)

It shall be drawn up in at least one of the official
the EU Member State in which the
languages of
inspection at the border post shall be carried out and
of the EU Member State of destination. However, these
Member States may allow other languages,
if neces-
sary, accompanied by an official translation.

If for reasons of identification of the items of the
consignment (schedule in point 8 of the model of
certificate), additional pages are attached to the certifi-
cate, these pages shall also be considered as forming
part of the original of the certificate by the application
of the signature and stamp of the certifying official, in
each of the pages.

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