2006/754/EC: Commission Decision of 6 November 2006 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(2006) 5266)   (Text with EEA relevance)
Date: 2006-11-06
Institutions: European Commission
Subjects: United States, cereal product, food inspection, food safety, genetically modified organism, market approval, rice, surveillance concerning imports

7.11.2006

EN

Official Journal of the European Union

L 306/17

II

(Acts whose publication is not obligatory)

COMMISSION

COMMISSION DECISION

of 6 November 2006

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(2006) 5266)

(Text with EEA relevance)

(2006/754/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(2)

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)

the European Parliament and of

Article 4(2) and Article 16(2) of Regulation (EC) No
1829/2003 of
the
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.

(3)

(4)

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

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
from commercial long-grain rice from the 2005 crop.

the

the presumption of

authorised according

risk on products
In view of
not
to Regulation (EC) No
1829/2003, 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 (3) provisionally banned the placing on
the market of
contaminated products. Those
emergency measures were confirmed by Commission
Decision 2006/601/EC (4) which repealed and replaced
Decision 2006/578/EC and 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’.

(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.

(3) OJ L 230, 24.8.2006, p. 8.
(4) OJ L 244, 7.9.2006, p. 27.

L 306/18

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Official Journal of the European Union

7.11.2006

(5)

(6)

(7)

(8)

(9)

requested for
The European Food Safety Authority,
scientific support on the issue,
issued a statement on
14 September 2006 concluding that although it can be
considered that the consumption of imported long grain
rice containing trace levels of ‘LL RICE 601’ is not likely
to pose an imminent safety concern to humans or
animals the available data are insufficient to enable a
full safety assessment of the genetically modified rice
‘LL RICE 601’
in accordance with the EFSA guidance
for risk assessment.

Checks carried out in the Member States have shown that
in addition to the rice products currently referred to in
Decision 2006/601/EC other
rice products may be
contaminated with the genetically modified rice ‘LL
RICE 601’. Such products should therefore be included
in the scope of Decision 2006/601/EC.

report as

Checks carried out by Member States have also revealed
the presence of genetically modified rice ‘LL RICE 601’ in
some consignments despite being accompanied by an
original analytical
requested by Decision
2006/601/EC. Contacts initiated thereafter with the US
authorities in order to eliminate the risk of presence of
unauthorised GM rice have not been successful. In those
circumstances, in order to ensure that no contaminated
product
to
guarantee the high level of health protection required
imposing restrictions to
in the Community, without
trade which go beyond what it is necessary, it appears
necessary, while maintaining the obligation to issue an
analytical report as requested by Decision 2006/601/EC,
to provisionally carry out systematic official sampling
and analysis of each consignment of specific products
originating from the United States before their placing
on the market.

is placed on the market and in order

Sampling methodologies play a crucial role in obtaining
representative and comparable results;
is therefore
appropriate to define a common protocol for sampling
the
and analysis for
genetically modified rice ‘LL RICE 601’.

the absence of

the control of

it

Since the measures provided for in this Decision have an
impact on the control resources of the Member States it
is appropriate to require that all costs resulting from
sampling, analysis and storage and all costs resulting
from official measures taken as regards non-compliant
consignments are to be borne by the importers or
food business operators concerned.

(10)

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

their impact and of

(11) Decision 2006/601/EC should therefore be amended

accordingly.

(12)

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 1 is replaced by the following:

‘Article 1

Scope

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

Product

rice in the husk, parboiled Long A

rice in the husk parboiled Long B

CN Code

1006 10 25

1006 10 27

rice in the husk other than parboiled Long A

1006 10 96

rice in the husk other than parboiled Long B

1006 10 98

husked (brown) rice Parboiled Long A

husked (brown) rice Parboiled Long B

husked (brown) rice Long A

husked (brown) rice Long B

semi-milled Parboiled rice Long A

semi-milled Parboiled rice Long B

semi-milled rice Long A

semi-milled rice Long B

wholly milled Parboiled rice Long A

wholly milled Parboiled rice Long B

wholly milled rice Long A

wholly milled rice Long B

broken rice (unless it is certified as not obtained
from Long-grain)

1006 20 15

1006 20 17

1006 20 96

1006 20 98

1006 30 25

1006 30 27

1006 30 46

1006 30 48

1006 30 65

1006 30 67

1006 30 96

1006 30 98

1006 40 00’

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Official Journal of the European Union

L 306/19

2. Article 2 is replaced by the following:

3. Article 3 is replaced by the following:

‘Article 2

Conditions for first placing on the market

‘Article 3

Other control measures

1. Member States shall allow the first placing on the
market of the products referred to in Article 1 only if the
consignment of
those products is accompanied by the
the
original of
products do not contain the genetically modified rice
“LL RICE 601”. That report shall be issued by an accredited
laboratory and based on a suitable and validated method for
detection of genetically modified rice “LL RICE 601”.

confirming that

an analytical

report

2. Member States shall ensure that, at the point of entry
into the Community, official sampling and analysis of each
consignment of products referred to in Article 1 is carried
out before they are placed on the Community market to
demonstrate that it does not contain genetically modified
rice “LL RICE 601”. For that purpose official sampling and
analysis shall be carried out in accordance with the methods
described in the Annex and within a maximum period of 15
working days.

The competent authorities of

the Member States
3.
issue an official accom-
referred to in paragraph 2 shall
panying document
the consignment has
been subject to official sampling and analysis and setting
out the result of the analysis.

indicating that

is

split, copies of

If a consignment

4.
the original
analytical report as referred to in paragraph 1 and of the
official accompanying document as referred to in paragraph
3 shall accompany each part of the split consignment up to
and including the wholesale stage. Those copies shall be
certified by the competent authority of the Member State
on whose territory the splitting has taken place.

Any presence of genetically modified rice “LL RICE
5.
601” detected by the controls provided for in paragraph 2
shall be reported to the Commission and the Member States
through the Rapid Alert System for food and feed established
by Article 50 of Regulation (EC) No 178/2002.

6. Member States shall by 31 December 2006 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.’

Member States shall take appropriate measures,
including
random sampling and analysis carried out in accordance
with the Annex, concerning the products referred to in
in order to verify the
Article 1 already on the market
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.’

4. Article 5 is replaced by the following:

‘Article 5

Recovery of costs

1.
All costs resulting from sampling, analysis, storage and
issuing of official accompanying documents and of copies of
analytical reports and accompanying documents pursuant to
to (4) shall be borne by the food business
Article 2(1)
operator responsible for the consignment or its represen-
tative.

2.
All costs related to official measures taken by the
non-compliant
as
competent
consignments shall be borne by the food business operator
responsible for the consignment or its representative.’

authorities

regards

5. Article 6 is replaced by the following:

‘Article 6

Review of the measures

The measures provided for in this Decision shall be reviewed
by 15 January 2007 at the latest’.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 6 November 2006

For the Commission

Markos KYPRIANOU
Member of the Commission

L 306/20

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Official Journal of the European Union

7.11.2006

ANNEX

Methods of sampling and analysis for official control regarding the non-authorised genetically modified organism
LL RICE 601 in rice products

1. Purpose and scope

The present annex is based on Recommendation 2004/787/EC (1). It takes in particular into account that the currently
available methods are qualitative and that it addresses the detection of a non-authorised GMO for which there is no
tolerance threshold. Samples intended for the official control for the absence of LL RICE 601 in rice products shall be
taken according to the methods described below. The bulk samples thus obtained shall be considered as representative
of the lots from which they are taken.

2. Definitions

For the purpose of the current annex, definitions of Recommendation 2004/787/EC apply.

3. Sampling lots of bulk commodities and preparation of the analytical samples

The number of incremental samples for the constitution of the bulk sample and the preparation of the analytical
samples shall be made in accordance with Recommendation 2004/787/EC. The size of the laboratory sample shall be
2,5 kg. For the purpose of Article 11(5) of Regulation (EC) 882/2004 (2), a second laboratory sample shall be
constituted.

4. Analysis of the laboratory sample

The control laboratory shall take from the homogenised laboratory sample four analytical samples of 240 grams. The
four analytical samples have to be ground and further analysed separately.

The PCR method to be used is the construct-specific method ‘P35S:BAR’
that has been developed by Bayer
CropScience and verified by the USDA and the JRC in its quality of Community reference laboratory for GM Food
and Feed. In case of positive results, the presence of LL RICE 601 shall be confirmed by the event-specific method.

The lot shall be considered to be positive when one of the four analytical samples is positive.

(1) OJ L 348, 24.11.2004, p. 18.
(2) OJ L 191, 28.5.2004, p. 1.