2008/162/EC: Commission Decision of 26 February 2008 amending Decision 2006/601/EC on emergency measures regarding the non-authorised genetically modified organism LL RICE 601 in rice products (notified under document number C(2008) 743) (Text with EEA relevance)
Date: 2008-02-26
Institutions: European Commission
Subjects: United States, cereal product, food inspection, food safety, genetically modified organism, market approval, rice, surveillance concerning imports

27.2.2008

EN

Official Journal of the European Union

L 52/25

COMMISSION DECISION

of 26 February 2008

amending Decision 2006/601/EC on emergency measures regarding the non-authorised genetically
modified organism ‘LL RICE 601’ in rice products

(notified under document number C(2008) 743)

(Text with EEA relevance)

(2008/162/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
and laying down
the European Food Safety Authority
food safety (1), and in particular
procedures in matters of
Article 53(1) thereof,

Whereas:

(1)

(2)

(3)

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 (2) provide that no genetically modified
food or feed is to be placed on the Community market
is covered by an authorisation granted in
unless it
accordance with that Regulation. Article 4(3)
and
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.

Article 53(1) of Regulation (EC) No 178/2002 provides
the possibility to adopt appropriate Community
for
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
be
measures taken by the Member States concerned.

satisfactorily

by means

contained

In view of
not

authorised according

the presumption of

risk on products
to Regulation (EC) No

(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. Regulation as amended by Commission
Regulation (EC) No 1981/2006 (OJ L 368, 23.12.2006, p. 99).

1829/2003, Commission Decision 2006/601/EC of
5 September 2006 on emergency measures regarding
the non-authorised genetically modified organism ‘LL
RICE 601’
in rice products (3) required Member States
not to allow the placing on the market of certain rice
products originating from the United States unless the
consignment
is accompanied by an original analytical
report issued by an accredited laboratory attesting that
the product does not contain genetically modified rice ‘LL
RICE 601’ and to carry out systematic official sampling
and analysis of each consignment of specific products
originating from the United States before their placing
on the market.

On 5 October 2007, the United States Department of
Agriculture (USDA) published the results of its investi-
gation on, in particular, the presence of ‘LL RICE 601’ in
US commercial rice. While the exact mechanisms of the
contamination could not be established,
the findings
the contamination by ‘LL
the source of
indicate that
RICE 601’ was limited.

The US Rice federation has adopted a plan aiming to
remove ‘LL RICE 601’
from the US export channels.
This plan includes testing of the seeds before planting,
as well as documentary and analytical controls at the
delivery points of the 2007 harvest. Only some aspects
of this plan are subject to regulatory requirements in
some US States. It is therefore necessary to ensure that
all the consignments of rice originating from the United
States of America imported in the European Union were
subject to this plan.

the

scope

falling

On 9 November 2007, USDA submitted a proposal of
protocol to the Commission that would ensure that the
products
of Decision
under
2006/601/EC are subject
to official sampling by the
Grain Inspection, Packers and Stockyards Administration
(GIPSA) and analysed using the ‘P35S:BAR’ method
referred to in Decision 2006/601/EC in a laboratory
participating successfully in the dedicated proficiency
In accordance with
program administered by GIPSA.
that protocol,
those products
the consignments of
would be accompanied by the original of an analytical
report and by a letterhead issued by GIPSA indicating
that ‘LL RICE 601’ was not detected.

(4)

(5)

(6)

(3) OJ L 244, 7.9.2006, p. 27. Decision as amended by Commission

Decision 2006/754/EC (OJ L 306, 7.11.2006, p. 17).

L 52/26

EN

Official Journal of the European Union

27.2.2008

(7)

(8)

(9)

(10)

involvement of the GIPSA, as described in
The official
the proposal of protocol, provides appropriate reas-
surances as to the quality of the controls made. As a
consequence, mandatory official sampling and analysis
the point of entry into the
by Member States at
Community is no more considered necessary.

Those measures should be reviewed within six months in
order to assess whether they are still necessary,
in the
the practical experience
light of
gained on the existing testing requirements.

their impact and of

Decision 2006/601/EC should therefore be amended
accordingly.

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

Decision 2006/601/EC is amended as follows:

1. Article 2 is replaced by the following:

‘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 if the
consignment of
is accompanied by the
following documents:

those products

(a) a statement from the food business operator responsible
for the consignment that the products do only contain
rice, from the 2007 or a subsequent harvest, that was
subject to the plan of the USA Rice federation aiming to
remove “LL RICE 601” from the US export channels; and

(b) the original of an analytical report issued by a laboratory
referred to in Annex II confirming that the products do
not contain the genetically modified rice “LL RICE 601”.
The analytical report shall be accompanied by an official
document issued by the Grain Inspection, Packers and
Stockyards Administration (GIPSA) of the United States
Department of Agriculture (USDA) in accordance with
the protocol described in Annex II.

If a consignment

2.
the documents
referred to in paragraph 1 shall accompany each part of
the split consignment up to and including the wholesale
stage. Those copies shall be certified by the competent

is split, copies of

authority of
splitting has taken place.’

the Member State on whose territory the

2. Article 3 is replaced by the following:

‘Article 3

Other control measures

take

shall

States

appropriate measures,
1. Member
including random sampling and analysis carried out
in
accordance with Annex I concerning the products referred
to in Article 1 presented for importation or 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)
through the Rapid Alert
System for food and feed.

results

2. Member States shall by 26 July 2008 at the latest
submit to the Commission a report of all analytical results
of official controls on consignments of products referred to
in Article 1.’

3. Paragraph 1 of Article 5 is replaced by the following:

‘1.
All costs resulting from issuing the accompanying
documents pursuant to Article 2(2) shall be borne by the
food business operator responsible for the consignment or
its representative.’

4. Article 6 is replaced by the following:

‘Article 6

Review of the measures

The measures provided for in this Decision shall be reviewed
by 26 August 2008 at the latest.’

5. In the heading of the Annex the word ‘Annex’ is replaced by

‘Annex I’.

6. The text in the Annex to this Decision is added as Annex II.

This Decision is addressed to the Member States.

Article 2

Done at Brussels, 26 February 2008.

For the Commission

Markos KYPRIANOU
Member of the Commission

27.2.2008

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Official Journal of the European Union

L 52/27

ANNEX

‘ANNEX II

Protocol for sampling and testing U.S.

long grain rice shipments before export from the United States of

America to the European Community

Sampling. Each consignment (lot) of U.S. long grain rice to be shipped to Europe shall be officially sampled by USDA's
in accordance with established sampling
Grain Inspection, Packers and Stockyards Administration (GIPSA) personnel
procedures. These procedures appear in GIPSA's Rice Inspection Handbook, Chapter 2, Sampling.

The size of the original bulk sample shall be in accordance with Commission Recommendation 2004/787/EC. GIPSA
personnel shall prepare a representative 2,5 kg lot composite sample for the testing laboratory and will retain an identical
2,5 kg file sample. GIPSA will apply a seal to the laboratory sample and record the seal number for future reference.

forward the sealed sample to one of the commercial testing laboratories
Testing. The applicant for service shall
participating successfully in the LibertyLink rice proficiency program administered by GIPSA and listed at
this
location: http://archive.gipsa.usda.gov/rdd/llriceprof.pdf Each laboratory tests pools of samples within its verified detection
level to achieve a 0,01 per cent level of detection.

The laboratory shall record the seal number, break the seal, and test four 240 gram samples taken from the single
laboratory sample. One extraction will be made from each sample. Two PCR analyses shall be made for each extraction
using the 35S:BAR method developed by Bayer CropScience and verified by both GIPSA and the JRC. The lot shall be
considered negative only when all sample results are negative.

Reporting. The laboratory shall report results, and the GIPSA seal number, on the lab report, and provide it to the
applicant for service. The applicant shall provide the lab report to the GIPSA office that sampled the lot. GIPSA will issue
an official document as follows, and provide it to the applicant:

“GIPSA officially sampled the lot of rice identified as (specify lot identification) and applied seal number (enter seal number).
(Enter lab name), who participates in the LibertyLink rice proficiency program administered by GIPSA, tested a sample
identified with this seal number and did not detect LibertyLink rice based on the verified 35S:BAR method. The lab report
is attached.” ’