2006/601/EC: Commission Decision of 5 September 2006 on emergency measures regarding the non-authorised genetically modified organism LL RICE 601 in rice products (notified under document number C(2006) 3932)   (Text with EEA relevance)
Date: 2006-09-05
Institutions: European Commission
Subjects: United States, cereal product, food inspection, food safety, genetically modified organism, market approval, rice, surveillance concerning imports

7.9.2006

EN

Official Journal of the European Union

L 244/27

COMMISSION DECISION

of 5 September 2006
on emergency measures regarding the non-authorised genetically modified organism ‘LL RICE 601’
in rice products

(notified under document number C(2006) 3932)

(Text with EEA relevance)

(2006/601/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

that information on possible contamination of exports to
the Community cannot be given at present. In addition,
they informed the Commission that those products had
not been authorised for placing on the market in the
United States either.

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,

(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 form
a comprehensive and common approach allowing rapid
and effective action to be taken and avoiding disparities
between the treatment of the situation by the various
Member States.

(4)

(5)

(6)

Whereas:

(1)

(2)

the European Parliament and of

Article 4(2) and Article 16(2) of Regulation (EC) No
the
1829/2003 of
Council of 22 September 2003 on genetically modified
food and feed provide that no genetically modified food
or feed (2) is to be placed on the Community market
is covered by an authorisation granted in
unless it
and
accordance with that Regulation. Article 4(3)
Article 16(3) of the same Regulation lay down that no
genetically modified food and feed may 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, that it does not
mislead the consumer or the user, and that it does not
differ from the food or feed it is intended to replace to
such an extent that its normal consumption would be
nutritionally disadvantageous for humans or animals.

On 18 August 2006, the authorities of the United States
of America informed the Commission that rice products
contaminated with the genetically modified rice ‘LL RICE
601’ (‘the contaminated products’), which have not been
authorised for placing on the market in the Community,
had been found in rice samples taken on the US market
long-grain rice from the 2005 crop.
from commercial
The contamination of products was reported to the US
authorities on 31 July 2006 by Bayer Crop Science,
which is the company that developed the genetically
modified rice ‘LL RICE 601’. The US authorities later
informed the Commission that it is still not known to
what extent the supply chain has been contaminated and

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

Regulation (EC) No 575/2006 (OJ L 100, 8.4.2006, p. 3).

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

to

adopt

possibility

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

satisfactorily

by means

contained

Since genetically modified rice ‘LL RICE 601’
is not
authorised under Community legislation and in view of
the presumption of risk on products not authorised
according to Regulation (EC) No 1829/2003, which
the precautionary principle laid
takes
down in Article 7 of Regulation (EC) No 178/2002, it
is appropriate to take emergency measures to prevent the
placing on the market
the
contaminated products.

in the Community of

into account

responsible for

that
the operators

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
food law and for
control satisfy the requirements of
It
verifying
is,
are met.
such requirements
therefore,
first placing
food and feed on the market who should be under the
duty to prove that they do not contain the contaminated
products. To this end, the measures provided for in this
Decision should require that consignments of specific
products originating from the United States may be
placed on the market only if an analytical report demon-
strating that the products are not contaminated with ‘LL
RICE 601’ is provided. The analytical report should be
issued by an accredited laboratory conforming to inter-
nationally recognised standards.

L 244/28

EN

Official Journal of the European Union

7.9.2006

(7)

(8)

(9)

In order to facilitate controls, all genetically modified
food and feed placed on the market should be subject
to a validated method of detection. Bayer Crop Science
has been requested to provide methods for detection of
‘LL RICE 601’ as well as control samples. It has made
available two methods which have been validated by the
Grain Inspection, Packers and Stockyards Administration
(GIPSA) of the US Department of Agriculture, in colla-
boration with the Community reference
laboratory
referred to in Article 32 of Regulation (EC) No
1829/2003.

The measures provided for in this Decision must be
proportionate and no more restrictive of trade than is
required and should therefore cover only products
considered likely to be contaminated with ‘LL RICE
601’, which according to the information received, are
imported from the United States into the Community.

Despite requests made by the Commission, the US autho-
rities have been unable to provide any guarantee that rice
products
imported from the United States will not
contain ‘LL RICE 601’.

(10) With regard to feed products or other food products not
covered by the measures provided for in this Decision,
Member States should monitor whether such products
have been contaminated by ‘LL RICE 601’. On the
basis of
the information provided by Member States,
the Commission will consider the need for any additional
appropriate measures.

(11)

Commission Decision 2006/578/EC of 23 August 2006
on emergency measures regarding the non-authorised
genetically modified organism LL RICE 601 in rice
products (1) was
adopted to ban provisionally the
placing on the market of contaminated products.

(12)

Those provisional measures should be confirmed.

(13)

It is therefore appropriate to repeal and replace Decision
2006/578/EC.

(14)

The measures provided for in this Decision should be
reviewed within six months in order to assess whether
they are still necessary,

(15)

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

in this Decision are in
Standing
the

opinion

the

of

(1) OJ L 230, 24.8.2006, p. 8.

HAS ADOPTED THIS DECISION:

Article 1

Scope

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

Product

CN Code

husked (brown) rice Parboiled Long A

1006 20 15

husked (brown) rice Parboiled Long B

1006 20 17

husked (brown) rice Long A

1006 20 96

husked (brown) rice Long B

1006 20 98

semi-milled Parboiled rice Long A

1006 30 25

semi-milled Parboiled rice Long B

1006 30 27

semi-milled rice Long A

semi-milled rice Long B

1006 30 46

1006 30 48

wholly milled Parboiled rice Long A

1006 30 65

wholly milled Parboiled rice Long B

1006 30 67

wholly milled rice Long A

wholly milled rice Long B

broken rice (unless it is certified free of
Long-grain origin)

1006 30 96

1006 30 98

1006 40 00

Article 2

Conditions for first placing on the market

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
detection of genetically modified rice ‘LL RICE 601’ and issued
by an accredited laboratory accompanying the consignment
demonstrates that
the product does not contain genetically
modified rice ‘LL RICE 601’.

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

7.9.2006

EN

Official Journal of the European Union

L 244/29

the operator

In the absence of an analytical report as referred to in paragraph
1,
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 demon-
strate that they do not contain genetically modified rice ‘LL
RICE 601’. Pending availability of
the
consignment
the
Community.

the analytical report,
shall not be placed on the market of

Member States shall
inform the Commission of positive (un-
favourable) 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 genetically modified rice ‘LL RICE 601’.
They shall
inform the Commission of positive (unfavourable)
results through the Rapid Alert System for food and feed.

Article 4

Contaminated consignments

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 measures

The measures provided for in this Decision shall be reviewed by
28 February 2007 at the latest.

Article 7

Repeal

Decision 2006/578/EC is repealed.

Article 8

Addressees

This Decision is addressed to the Member States.

Done at Brussels, 5 September 2006.

Member States shall take the necessary measures to ensure that
the products referred to in Article 1 that are found to contain
genetically modified rice ‘LL RICE 601’ are not placed on the
market.

For the Commission

Markos KYPRIANOU
Member of the Commission