2005/317/EC: Commission Decision of 18 April 2005 on emergency measures regarding the non-authorised genetically modified organism Bt10 in maize products (notified under document number C(2005) 1257) (Text with EEA relevance)
Date: 2005-04-18
Institutions: European Commission
Subjects: EU Member State, United States, cereal product, foodstuffs legislation, genetically modified organism, import, maize, market approval, originating product, plant health control

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Official Journal of the European Union

21.4.2005

II

(Acts whose publication is not obligatory)

COMMISSION

COMMISSION DECISION

of 18 April 2005

on emergency measures regarding the non-authorised genetically modified organism Bt10 in maize
products

(notified under document number C(2005) 1257)

(Text with EEA relevance)

(2005/317/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(1) thereof,

Whereas:

(1)

(2)

of

and

4(2)

Regulation

Articles
(EC)
16(2)
No 1829/2003 of the European Parliament and of the
Council of 22 September 2003 on genetically modified
food and feed (2) provide that no genetically modified
food or feed shall be placed on the Community market
is covered by an authorisation granted in
unless it
accordance with that Regulation. Articles 4(3) and
16(3) of
same Regulation lay down that no
genetically modified food and feed shall be authorised
unless it has been adequately and sufficiently demon-
strated that it does not have adverse effects on human
health, animal health or the environment and that it does
not mislead the consumer or the user, and differ from
the food or feed it is intended to replace to such an
extent
its normal consumption would be nutri-
tionally disadvantageous for humans or animals.

that

the

On 22 March 2005, the authorities of the United States
of America
the
Commission that maize products contaminated with
called Bt10 (the
the

genetically modified maize

authorities)

(the US

informed

contaminated products), which have not been authorised
for placing on the market in the Community, were likely
to have been exported to the Community since 2001
and to continue to be exported. In addition, these autho-
rities informed the Commission that those products were
not authorised for placing on the market in the United
States of America either.

(3) Without prejudice to the control obligations of

the
Member States, the measures to be adopted further to
the likely imports of contaminated products should be
subject
to a comprehensive and common approach
allowing rapid and effective action to be taken and
avoiding disparities between Member States
in the
treatment of the situation.

(4)

(5)

to

adopt

possibility

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

Although the contamination of products was reported by
Syngenta, which is the company that developed the
genetically modified maize Bt10, to the US authorities
in December 2004, no data enabling a safety assessment
of the genetically modified maize Bt10 by the European
Food Safety Authority (the Authority) according to the
standards laid down in Regulation (EC) No 1829/2003
the US authorities.
were provided by Syngenta or
According to the Authority (3),
in the absence of this
information, the safety of Bt10 has yet to be confirmed.

(1) OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Regulation

(EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4).

(2) OJ L 268, 18.10.2003, p. 1.

(3) Statement of the European Food Safety Authority issued on 12 April

2005.

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(6)

(7)

(8)

(9)

in

chosen

Considering the absence of sufficient data enabling a
safety assessment of
the genetically modified maize
to achieve the high level of health
Bt10 in order
and
protection
the
the Community,
authorised
risk on products not
presumption of
according to Regulation (EC) No 1829/2003, which
takes
the precautionary principle laid
down in Article 7 of Regulation (EC) No 178/2002, it
is appropriate to take emergency measures in order to
prevent the placing on the market in the Community of
the contaminated products.

into account

According to the general requirements laid down in
Regulation (EC) No 178/2002, food and feed business
operators have primary legal responsibility for ensuring
that foods or feeds within the businesses under their
control satisfy the requirements of
food law and for
verifying that such requirements are met. The duty to
prove the absence of placing on the market of
the
contaminated products should therefore rely on the
for
operator
first placing on the
responsible
market. To this end,
the emergency measures should
require that consignments of specific products originating
from the United States of America may be placed on the
market only if an analytical report demonstrating that the
products are not contaminated with the genetically
modified maize Bt10 is provided. The analytical report
should be issued by an accredited laboratory according to
internationally recognised standards.

the

In order to facilitate controls, all genetically modified
food and feed placed on the market should be subject
to a validated method of detection. Syngenta has been
requested to provide the method for the event-specific
the genetically modified maize Bt10 as
detection of
well as control samples. Consequently, the Community
reference laboratory referred to in Article 32 of Regu-
lation (EC) No 1829/2003 (the CRL) has been asked to
validate the detection method for this product on the
basis of data provided by Syngenta. The detection
method is made available by Syngenta and can also be
found at the following address: http://gmo-crl.jrc.it

the measures provided for

Considering that
in this
Decision must be proportionate and no more restrictive
of trade than is required, only products considered as
likely to be contaminated with genetically modified
maize Bt10 should be covered. According to the infor-
mation received from the US authorities, neither
any product
genetically modified maize grain nor
derived therefrom are imported from the United States
of America to the Community, with the exception of
corn gluten feed and brewers grains
feed use.
Accordingly, the latter products should be the subject
of the said measures.

for

(10) Despite requests made by the Commission, the US autho-
rities were not in a position to provide any guarantee on
the absence of Bt10 in corn gluten feed and brewers
from genetically
grains
produced
in the
imported
modified organisms, which are
Community, considering the lack of segregation or trace-
ability measures in the United States of America on these
products.

containing

or

(11) With regard to food products, according to the infor-
mation made available to the Commission, no genetically
modified maize imported from the United States of
America is used in the production of
food in the
Community. Member States should however monitor
whether genetically modified maize food products are
present on the market and whether these have been
contaminated by Bt10. On the basis of the information
the Commission will
provided by Member States,
consider the need of any appropriate measure.

(12)

These measures should be evaluated after six months in
order to assess whether they are still necessary.

(13)

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

in this Decision are in
Standing
the

opinion

the

of

HAS ADOPTED THIS DECISION:

Article 1

Scope

This Decision applies to the following products originating from
the United States of America:

— corn gluten feed containing or produced from genetically

modified maize within CN code 2309 90 20,

— brewers grains containing or produced from genetically

modified maize within CN code 2303 30 00.

Article 2

Conditions for first placing on the market

1. Member States shall allow the first placing on the market
of the products referred to in Article 1 only where an original
analytical report based on a suitable and validated method for
the event-specific detection of genetically modified maize Br10
and issued by an accredited laboratory accompanying the
consignment demonstrates that the product does not contain
Bt10 maize or feed produced from Bt10 maize.

If a consignment of products referred to in Article 1 is split, a
certified copy of the analytical report provided for in paragraph
1 shall accompany each part of the split consignment.

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In the absence of such an analytical report, the operator
2.
established in the Community who is responsible for the first
placing on the market of the product shall have the products
referred to in Article 1 tested to demonstrate that they do not
contain Bt10 maize or feed produced from Bt10 maize. Pending
availability of the analytical report, the consignment shall not be
placed on the market of the Community.

3. Member States shall inform the Commission of positive
(unfavourable) results through the Rapid Alert System for food
and feed.

Article 3

Other control measures

shall

take appropriate measures,

including
Member States
random sampling and analysis,
concerning the products
referred to in Article 1 already on the market in order to
verify the absence of Bt10 maize or feed produced from Bt10
maize. They shall
inform the Commission of positive (unfa-
vourable) results through the Rapid Alert System for food and
feed.

Article 4

Contaminated consignments

Member States shall take the necessary measures to ensure that
the products referred to in Article 1 that are found to contain

Bt10 maize or feed produced from Bt10 maize are not placed
on the market.

Article 5

Recovery of costs

Member States shall ensure that the costs incurred in the imple-
mentation of Articles 2 and 4 are borne by the operators
responsible for the first placing on the market.

Article 6

Review of the measure

This Decision shall be reviewed by 31 October 2005 at the
latest.

Article 7

Addressees

This Decision is addressed to the Member States.

Done at Brussels, 18 April 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission