2008/798/EC: Commission Decision of 14 October 2008 imposing special conditions governing the import of products containing milk or milk products originating in or consigned from China, and repealing Commission Decision 2008/757/EC (notified under document number C(2008) 6086) (Text with EEA relevance)
Date: 2008-10-14
Institutions: European Commission
Subjects: China, baby food, chemical product, food inspection, import restriction, milk, milk product

L 273/18

EN

Official Journal of the European Union

15.10.2008

COMMISSION

COMMISSION DECISION

of 14 October 2008

imposing special conditions governing the import of products containing milk or milk products
originating in or consigned from China, and repealing Commission Decision 2008/757/EC

(notified under document number C(2008) 6086)

(Text with EEA relevance)

(2008/798/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to Regulation (EC) No 178/2002 of the European
Parliament and of the Council of 28 January 2002 laying down
the general principles and requirements of food law, establishing
the European Food Safety Authority
and laying down
food safety (1), and in particular
procedures in matters of
Article 53(2), second subparagraph, thereof,

Whereas:

(1)

(2)

to

adopt

possibility

Article 53 of Regulation (EC) No 178/2002 provides for
appropriate Community
the
emergency measures for food and feed imported from
a third country in order
to protect human health,
the environment, where the risk
animal health or
cannot
of
by means
be
measures taken by the Member States individually.

satisfactorily

contained

The European Commission was recently made aware that
high levels of melamine were found in infant milk and
other milk products in China. Melamine is a chemical
intermediate used in the manufacture of amino resins
and plastics and is used as a monomer and as an
additive for plastics. High levels of melamine in food
can result in very severe health effects.

(3)

Imports of milk and milk products,
including milk
powder, originating from China are not allowed into
the Community; however, certain composite products

(4)

(5)

(i.e. products which contain at the same time a processed
product of animal origin and a product of non-animal
origin) containing processed milk components might
have reached the European Union's markets.

checks pursuant

Although factual information available indicates that no
composite products are imported which are intended for
infants or young
the particular nutritional uses of
children, certain such composite products, depending of
their
specific formulation and in particular on the
proportion of milk product content, could have been
import without undergoing systematic
presented for
border
to Commission Decision
2007/275/EC of 17 April 2007 concerning lists of
to controls at
animals and products
border
under Council Directives
91/496/EEC and 97/78/EC (2). Taking into account that
such products represent the primary, and in some cases
sole,
infants and young
for
children,
it is appropriate to prohibit the import into
the Community of any such products originating from
should ensure that any such
China. Member States
products which were to be found on the market
should be destroyed without delay.

source of nourishment

inspection posts

to be subject

a

diet,

after

from the

As regards other composite products (such as biscuits
and chocolate), which are only a minor part of a
European
request
varied
Commission for an assessment of the risks related to
the
the presence of melamine in composite product,
European Food Safety Authority
issued a
statement in which it concludes that the highest risk
scenario
would be
according to which children with high daily consumption
of biscuits
the highest
proportion of milk powder (which varies between 16 %
and more than 20 %), with a contamination equal to the
highest level found in milk powder from China, could
potentially exceed the tolerable daily intake (TDI) of
melamine (0,5 mg/kg body weight).

represented by

and chocolate

containing

a worst

(EFSA)

case

(1) OJ L 31, 1.2.2002, p. 1.

(2) OJ L 116, 4.5.2007, p. 9.

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Official Journal of the European Union

L 273/19

(6)

(7)

(8)

(9)

content of

immediately

in feed and food. Taking into account

In order to counter the risk for health that may result
from exposure
such
to the melamine
composite products, Member States are required under
Commission Decision 2008/757/EC (1)
to ensure that
all composite products containing at least 15 % of milk
product, originating from China, are systematically tested
before import into the Community and that all such
products which are shown to contain melamine in
destroyed.
are
excess of 2,5 mg/kg
such as migration
sources,
Melamine from different
from food contact materials, pesticide use, etc. can be
present
the
available occurrence data, the level of 2,5 mg/kg is the
appropriate level to distinguish between the unavoidable
background presence of melamine and unacceptable
adulteration. This level responds also to the need to
ensure a large margin of safety. Member States have
reported significant difficulties in establishing the exact
milk or milk product content of composite products. As
a consequence, the value of 15 % above is largely devoid
is
relevance for deciding whether a consignment
of
In
subject
to import.
order
controls
it is therefore appropriate to establish the
procedures,
requirement of
exact
amount of milk or milk products in the composite
products.

requirements prior
and simplify

to control
to streamline

irrespective of

controls

import

the

that

appropriately

Member States
composite
should also ensure
products which are already present in the Community
tested and withdrawn from the
are
market if necessary. The costs of tests at import and of
official measures taken as regards products found to be
non-compliant with the maximum level
in question
should be borne by the
feed and food business
operator responsible for the products.

Article 2

Control measures

the

import

1. Member States
into the
shall prohibit
Community of composite products containing milk or milk
products, intended for the particular nutritional use of infants
and young children within the meaning of Council Directive
89/398/EEC (2) on foods for particular nutritional uses, originat­
ing or consigned from China. Member States shall also ensure
that any such product found after the entry into force of this
Decision on the market shall be immediately withdrawn and
destroyed.

2. Member States shall carry out documentary, identity and
physical
all
consignments originating in or consigned from China of
composite products, including feed, containing milk products.

laboratory

including

analysis,

checks,

on

Member States may carry out random checks prior to importing
other feed and food products with a high protein content orig­
inating from China.

Such checks shall in particular aim at ascertaining that the level
of melamine,
if any, does not exceed 2,5 mg/kg product.
Consignments shall be detained pending the availability of the
results of the laboratory analysis.

In order for the Commission to be able to reassess
appropriateness of these measures in due time, Member
States should inform the Commission of unfavourable
results through the Rapid Alert System for Food and
Feed and should report
favourable results on a two
weeks basis.

3.
The checks referred to in paragraph 2, first subparagraph,
shall be carried out at points of control specifically designated
by the Member States for that purpose. Member States shall
make the list of points of control available to the public and
communicate it to the Commission.

The measure provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Decision are in
Standing
the

opinion

the

of

4. Member States shall report any unfavourable result of the
laboratory analysis referred to in paragraph 2 through the Rapid
Alert System for Food and Feed. They shall report
to the
Commission on favourable results on a two weeks basis.

HAS ADOPTED THIS DECISION:

Article 1

For the purposes of this Decision, references to China shall be
intended to the People's Republic of China.

5. Member States shall take the necessary measures to ensure
that products referred to in paragraph 2, and feed and food
products with a high protein content, as appropriate, which are
already placed on the market are subject to an appropriate level
of controls aimed at ascertaining the level of melamine.

(1) OJ L 259, 27.9.2008, p. 10.

(2) OJ L 186, 30.6.1989, p. 27.

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Official Journal of the European Union

15.10.2008

Any product found to contain melamine in excess of 2,5
following controls performed in accordance

6.
mg/kg product,
with paragraphs 2 and 5, shall be destroyed without delay.

Article 4

Review of the measures

7. Member States shall ensure that the costs incurred in the
implementation of paragraph 2 are borne by the operators
the cost of official
responsible for
to be in
measures
compliance with this Decision are borne by the feed and food
business operator responsible for that product.

the import, and that

regards products

found not

taken as

Article 3

Prior notification

Feed and food business operators or their representatives shall
give prior notification to the point of control referred to in
Article 2(3) of the estimated date and time of arrival of all
consignments originating in or consigned from China of
composite products, including feed, containing milk products.

The measures laid down in this Decision shall be regularly
reassessed in the light of the results of the controls carried
out by the Member States.

Article 5

Decision 2008/757/EC is repealed.

Article 6

This Decision is addressed to the Member States.

Done at Brussels, 14 October 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission