Corrigendum to corrigendum to 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 (OJ L 189, 27.5.2004)
Date: 2005-04-12
Institutions: European Commission
Subjects: health certificate, health control, health legislation, human nutrition, import, milk, milk product

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Corrigendum to corrigendum to 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

(Official Journal of the European Union L 189 of 27 May 2004)

Decision 2004/438/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
Community,

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 prod-
ucts (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 produc-
tion, 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,

(3)

(4)

(5)

Whereas:

Commission Decision 95/340/EC (3) draws up a provi-
sional list of third countries from which Member States
authorise 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 of the
treatment against the foot-and-mouth virus provided for in
Council Directive 2003/85/EC (5) laying down Community
measures for the control of foot-and-mouth disease.

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

(1)

(2)

Directive 92/46/EEC 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, 21.1.2002, p. 11.

(6)

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.

(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).

(7)

(8)

(9)

(10)

(11)

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

(13) However specific conditions for transits via the Commu-
nity of consignments to and from Russia should be fore-
seen 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.

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

(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 is
appropriate to specify the border inspection posts desig-
nated for the control of such transits taking into account
this Decision.

However, it is necessary in order to safeguard the disease
situation in the Community to further ensure that consign-
ments of milk transiting through the Community comply
with the animal health import conditions applicable for
authorised countries.

(15)

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

HAS ADOPTED THIS DECISION:

Article 1

Council Decision 79/542/EEC of 21 December 1976 draw-
ing up a list of third countries or parts of third countries,
and laying down animal and public health and veterinary
certification conditions for the importation into the Com-
munity of certain live animals and their fresh meat (2), has
recently been amended to include general transit condi-
tions and a derogation for transit between Russia with a
reference to the specific border inspection posts designated
for this latter purpose.

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.

In the light of experience, it appears that the presentation
to the border inspection post, pursuant to Article 7 of
Directive 97/78/EC, of the original veterinary documents,
established in the exporting third country to fulfil the regu-
latory requirement of the third country of destination, 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 sat-
isfied; it is therefore appropriate to establish a specific
model of animal health certificate to be used in transit situ-
ations for the products concerned.

(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 countries
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.

(1) OJ L 24, 30.1.1998, p. 9. Directive as last amended by the Act of

Accession of 2003.

Article 2

1. Member States shall authorise imports of raw milk and raw
milk-based products from third countries so authorised in col-
umn 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.

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

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

Decision 2004/372/EC (OJ L 118, 23.4.2004, p. 45).

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

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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

— “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 countries
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
in which there is a threat of foot-and-mouth disease, how-
ever those countries already authorised for such imports
(where there is no threat of foot and mouth) may use this
model.

The health certificates shall be completed in accordance

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

(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,

Article 4

or

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

or

(e) a HTST treatment

combined with another physical

treatment 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 treat-
ments or be produced from milk treated in accordance with the
treatments laid down above.

Article 3

1.
Consignments of milk and milk-based products from third
countries authorised in accordance with Article 2 shall be accom-
panied by, and comply with, conditions laid down in, a health cer-
tificate 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, standardisation centre, treatment establishment
or processing establishment,

— “Milk-RMP” for raw milk products,

1.
Consignments of milk and milk-based products, introduced
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 Directive 97/78/EC and
not intended for importation into the EC, shall comply with the
following requirements:

(a)

(b)

(c)

(d)

2.

they shall come from the territory of a third country or a part
thereof authorised in Annex I to this Decision, according to
the treatment required for the product concerned as laid
down in Article 2;

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;

they shall be accompanied by an animal health certificate
established in accordance with the model laid down in Part 3
of Annex II to this Decision, signed by an official veterinar-
ian of the competent veterinary services of the third country
concerned;

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.

(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 des-
ignated 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 con-
ditions 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;

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(ii)

the documents accompanying the consignment
and referred to in Article 7 of Directive 97/78/EC
shall be stamped “ONLY FOR TRANSIT TO RUS-
SIA VIA THE EC” on each page by the official vet-
erinarian of the competent authority responsible
for the border inspection post;

(iii) the procedural

in
Article 11 of Directive 97/78/EC shall be complied
with;

requirements provided for

(iv) the consignment is certified as acceptable for tran-
sit on the Common Veterinary Entry Document by
the Official Veterinarian of the Border Inspection
Post of introduction.

(b) Unloading or storage on EC territory of such consign-
ments, as defined in Article 12 (4) or Article 13 respec-
tively of Directive 97/78/EC, shall not be allowed.

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

Article 6

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

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 para-
graph 1 of Article 8 at the latest.

Article 8

1.

This Decision shall apply from 1 May 2004.

Article 4(1) and Part 3 of Annex II shall only apply from

2.
1 January 2005.

3.
References made by Community legislation to the list of
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.

Article 9

Article 5

This Decision is addressed to the Member States.

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

Done at Brussels, 29 April 2004.

For the Commission
David BYRNE
Member of the Commission

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ANNEX I

“+”:
“0”:

country is authorised
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

KE

MA

MG

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

Kenya

Morocco

Madagascar

MK (*)

Former Yugoslav Republic of Macedonia

MR

MU

MX

NA

NI

NZ

Mauritania

Mauritius

Mexico

Namibia

Nicaragua

New Zealand

+

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

0

0

+

0

0

0

+

0

0

+

0

0

0

+

0

0

0

0

0

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

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ISO code of
third country

Third country

Column A

Column B

Column C

PA

PY

RO

RU

SG

SV

SZ

TH

TN

TR

UA

US

UY

ZA

Panama

Paraguay

Romania

Russia

Singapore

El Salvador

Swaziland

Thailand

Tunisia

Turkey

Ukraine

United States of America

Uruguay

South Africa

ZW

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

+

+

+

+

+

+

+

+

+

+

+

+

+

+

+

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

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, standardisation centre, treatment establishment or processing establishment.

“Milk-RMP”: for raw milk products from third countries or parts of third countries included in Annex I column A.

“Milk-HTB”:

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.

“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 C.

“Milk-T/S”:

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

Notes

(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 to the milk and milk-based products con-
cerned. 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.

(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 lan-
guages of the EU Member State in which the inspec-
tion at the border post shall be carried out and of the
EU Member State of destination. However, these Mem-
ber States may allow other languages, if necessary,
accompanied by an official translation.

If for reasons of identification of the items of the con-
signment (schedule in point 8 of the model of certifi-
cate), additional pages are attached to the certificate,
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.

(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 num-
ber 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.

(i) The original of the certificate must accompany the
consignment at the EU border inspection post.

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PART 2

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Part 3

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