2008/289/EC: Commission Decision of 3 April 2008 on emergency measures regarding the unauthorised genetically modified organism Bt 63 in rice products (notified under document number C(2008) 1208) (Text with EEA relevance)
Date: 2008-04-03
Institutions: European Commission
Subjects: cereal product, food inspection, foodstuffs legislation, genetically modified organism, market approval, rice, surveillance concerning imports

9.4.2008

EN

Official Journal of the European Union

L 96/29

(Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory)

II

DECISIONS

COMMISSION

COMMISSION DECISION

of 3 April 2008
on emergency measures regarding the unauthorised genetically modified organism ‘Bt 63’ in rice
products

(notified under document number C(2008) 1208)

(Text with EEA relevance)

(2008/289/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
the European Food Safety Authority
and laying down
food safety (1), and in particular
procedures in matters of
Article 53(1), thereof,

Whereas:

(1)

Articles 4(2)
and 16(2) of Regulation (EC) No
the
1829/2003 of
the European Parliament and 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
unless it
is covered by an authorisation granted in
accordance with that Regulation. Articles 4(3) and
16(3) of
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.

the

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

Regulation (EC) No 202/2008 (OJ L 60, 5.3.2008, p. 17).

(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).

(3)

(4)

In September 2006 rice products originating from China
contaminated with the unauthorised genetically modified
rice ‘Bt 63’ were discovered in the United Kingdom,
France and Germany and notified to the Rapid Alert
System for Food and Feed (RASFF).

products

In response,

The Chinese competent authorities were immediately
requested to provide detailed information concerning
the genetic constructs of
the unauthorised genetically
modified rice ‘Bt 63’. Explanations were also requested
as regards the origin of the presence on the Chinese
market of genetically modified rice and the way the
Chinese competent authorities intended to ensure that
Community
exported
complied
requirements.
authorities
conducted checks on the cases notified in the RASFF
and suspended exports by the enterprises concerned.
They also decided to carry out testing on exported rice
and rice products and required exporting enterprises to
raw material purchasing.
strengthen controls over
the
Furthermore,
Commission concerning the overall situation of GM
rice in the Chinese market and the Bt genetic construct
concerned, confirming that the genetically modified rice
‘Bt 63’ is not authorised on the Chinese market.

information was

the Chinese

provided

with

to

during

The Member States were immediately informed of the
Standing
the meetings
situation
Committee on the Food Chain and Animal Health held
on 11 September and 23 October 2006. Member States
and operators were also reminded in writing of their
obligations to ensure that no unauthorised GMO is
placed on the EU market.

the

of

L 96/30

EN

Official Journal of the European Union

9.4.2008

findings of

the unauthorised genetically
After several
modified rice ‘Bt 63’ were notified through the RASFF
in the period between September and October 2006, the
flow of rapid alerts stopped, supporting the presumption
that the measures taken by the Chinese authorities were
effective.

(11)

according

Since the genetically modified rice ‘Bt 63’
is not
authorised under Community legislation and in view of
risk attached to products not
the presumption of
authorised
No
to
1829/2003, which takes into account the precautionary
principle laid down in Article 7 of Regulation (EC) No
178/2002, emergency measures
should be taken to
prevent the contaminated products being placed on the
Community market.

Regulation

(EC)

(5)

(6)

(7)

(8)

(9)

In February 2007, a new finding of the unauthorised
genetically modified rice ‘Bt 63’ was once again notified
through the RASFF. This new alert concerned a shipment
of rice protein concentrate for feed use which reached
Greece via the Netherlands. The shipment in question left
China on 20 December 2006, thus after the implemen-
tation of the control measures by the Chinese authorities.
this new alert and
Informed by the Commission of
requested by it
the
Chinese authorities decided to strengthen the sampling
and testing of rice products and required rice products to
be accompanied by an official Chinese Inspection and
Quarantine Certificate. The Standing Committee on the
informed on
Food Chain and Animal Health was
2 March 2007.

to provide additional guarantees,

Notwithstanding the measures announced by the Chinese
authorities, several other alerts concerning the presence
of the unauthorised genetically modified rice ‘Bt 63’ were
subsequently reported.

unable

authorities were

the
Despite reiterated requests by the Commission,
the
provide
Chinese
Commission’s Joint Research Centre (JRC) with control
samples and a protocol of a detection method that were
qualitatively and quantitatively appropriate for the JRC to
validate the detection method used by the Chinese
control authorities.

to

Considering the failure of the Chinese competent auth-
orities to provide sufficient guarantees of the absence of
the unauthorised genetically modified rice ‘Bt 63’ in rice
products originating from China and without prejudice
to the
the Member States,
measures should be adopted to ensure 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.

control obligations of

to

possibility

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

satisfactorily

by means

contained

It

that

(12) 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
is,
are met.
such requirements
verifying
therefore, the operator responsible for first placing food
and feed on the market who should be under the duty to
they do not contain the contaminated
prove that
the measures provided for in
products. To that end,
this Decision should require
consignments of
specific products originating from China may be placed
on the market only if an analytical report is provided
demonstrating that the products are not contaminated
with the unauthorised genetically modified rice ‘Bt 63’.
The analytical report should be issued by an accredited or
official
internationally
conforming
recognised standards. In the case of an analytical report
issued by an accredited laboratory it seems appropriate to
is endorsed by the relevant
foresee that
competent authority.

this report

laboratory

that

to

(13) Due to the lack of a validated detection method and
control samples of adequate quality and quantity —
to facilitate controls — the analytical
and in order
should be issued using the construct-specific
report
(2006) (1). The
method developed by D. Mäde et al.
Community Reference
for Genetically
Modified Food and Feed (CRL-GMFF) within the Joint
judged this method to be
Research Centre
currently the most appropriate one.

Laboratory

(JRC)

(14)

For the purpose of the sampling and detecting activities
required in order to prevent that products contaminated
with the unauthorised genetically modified rice ‘Bt 63’
are placed on the market, account should be taken of
the Commission Recommendation 2004/787/EC of
4 October 2004 on technical guidance for sampling
and detection of genetically modified organisms and
material produced from genetically modified organisms
as or in products in the context of Regulation (EC)
No 1830/2003 (2).

(1) European Food Research and Technology, 224:271-278 (2006).
(2) OJ L 348, 24.11.2004, p. 18.

9.4.2008

EN

Official Journal of the European Union

L 96/31

(15)

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 orig-
inating in or consigned from China into the Community
and considered likely to be contaminated with the
unauthorised genetically modified rice ‘Bt 63’. Given
the huge variety of products that could be contaminated
with the unauthorised genetically modified rice ‘Bt 63’, it
seems appropriate to target a long list of products which
could contain, consist or be produced from rice. Some of
the identified products, however, may or may not be
containing, consisting or produced from rice. It seems
therefore proportionate to allow the operators to issue
a simple declaration when the product is not containing,
thus avoiding the
consisting or produced from rice,
compulsory analysis and certification.

analytical report issued by a Chinese accredited laboratory, the
analytical report shall be endorsed by the relevant competent
authority (1).

2.
If a consignment of products referred to in Article 1 is
split, a copy of the analytical report shall accompany each part
of the split consignment. In the absence of an analytical report
as referred to in paragraph 1, the operator 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 the
genetically modified rice ‘Bt 63’. Pending availability of
the
analytical report, the consignment shall not be placed on the
Community market.

(16)

The situation concerning the possible contamination of
rice product with the unauthorised GM rice ‘Bt63’ should
be reviewed within six months in order to assess whether
the measures provided for
in this Decision are still
necessary.

referred to in the Annex is not
3. Where a product
containing, consisting or produced from rice,
the original
analytical report may be replaced by a statement (2) from the
operator responsible for the consignment indicating that the
food is not containing, consisting or produced from rice.

(17)

It is appropriate to foresee a reasonable period of time
between the entry into force and the date of applicability
of this Decision,
in order to allow the Member States
take the practical arrangements for its implementation.

(18)

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

in this Decision are in
Standing
the

opinion

the

of

Article 3

Control measures

shall

take appropriate measures,

Member States
including
random sampling and analysis carried out using the method
referred to in Article 2, concerning the products referred to
importation or already on the
in Article 1 presented for
market in order to ensure compliance with the requirements
of
inform the Commission of
positive (unfavourable) results through the Rapid Alert System
for Food and Feed. Negative (favourable)
shall be
reported to the Commission on a three-monthly basis.

this Decision. They shall

results

HAS ADOPTED THIS DECISION:

Article 1

Scope

This Decision applies to the food and feed products listed in the
Annex, originating in or consigned from China.

Article 4

Contaminated consignments

Member States shall take the necessary measures to ensure that
products referred to in Article 1 that are found to contain, to
consist or to be produced from the genetically modified rice ‘Bt
63’ are not placed on the market.

Article 5

Recovery of costs

Article 2

Conditions for first placing on the market

report based on the

1. Member States shall allow the first placing on the market
of the products referred to in Article 1 only where an original
construct-specific method
analytical
developed by D. Mäde et al., for detection of the genetically
modified rice ‘Bt 63’,
issued by an official or accredited
laboratory and accompanying the consignment demonstrates
that the product does not contain, consist or is not produced
from the genetically modified rice ‘Bt 63’. In the case of an

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.

(1) The analytical report shall be drawn up in a language understood by
the certifying officer, enabling the certifying officer to be fully aware
of the significance of the contents of each analytical report he signs
and in a language understood by the control official of the country
of import.

(2) The statement shall be drawn up in a language understood by the
operator, enabling the operator to be fully aware of the significance
of
the statement he signs and in a language
understood by the control official of the country of import.

the contents of

L 96/32

EN

Official Journal of the European Union

9.4.2008

Article 6

Re-assessment of the measures

The situation shall be reassessed by 15 October 2008 at the latest.

This Decision is applicable from 15 April 2008.

Article 7

Applicability

This Decision is addressed to the Member States.

Article 8

Addressees

Done at Brussels, 3 April 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

9.4.2008

EN

Official Journal of the European Union

L 96/33

ANNEX

Product

Rice in the husk (‘paddy’ or rough)

Husked (brown) rice

Semi-milled or wholly milled rice, whether or not polished or glazed

Broken rice

Rice flour

Rice groats and meal

Rice pellets

Flaked rice grains

Rolled or flaked cereal grains (excluding grains of oats, wheat, rye,
maize and barley, and flaked rice)

Rice starch

Preparations for infant use, put up for retail sale

CN code

1006 10

1006 20

1006 30

1006 40 00

1102 90 50

1103 19 50

1103 20 50

1104 19 91

1104 19 99

1108 19 10

1901 10 00

Uncooked pasta, not stuffed or otherwise prepared, containing eggs

1902 11 00

Uncooked pasta, not stuffed or otherwise prepared, not containing
eggs

Stuffed pasta, whether or not cooked or otherwise prepared

Other pasta (other than uncooked pasta, not stuffed or otherwise
prepared, and other than stuffed pasta, whether or not cooked or
otherwise prepared)

Prepared foods obtained by swelling or roasting cereals or cereal
products, obtained from rice

Preparations of the muesli-type based on unroasted cereal flakes

from
Prepared foods obtained from unroasted cereal
mixtures of unroasted cereal
flakes or swelled cereals, obtained
from rice (excluding preparations of the muesli-type on the basis
of unroasted cereal flakes)

flakes or

Rice, pre-cooked or otherwise prepared, not elsewhere specified or
included (excluding flour, groats and meal,
food preparations
obtained by swelling or roasting or from unroasted cereal flakes or
from mixtures of unroasted cereal flakes and roasted cereal flakes or
swelled cereals)

Ricepaper

Bran, sharps and other residues, whether or not in the form of
pellets, derived from the sifting, milling or other working of rice
with a starch content not exceeding 35 % by weight

1902 19

1902 20

1902 30

1904 10 30

1904 20 10

1904 20 95

1904 90 10

ex 1905 90 20

2302 40 02

L 96/34

EN

Official Journal of the European Union

9.4.2008

Product

Bran, sharps and other residues, whether or not in the form of
pellets, derived from the sifting, milling or other working of rice
other than with a starch content not exceeding 35 % by weight

Peptones and their derivatives; other protein substances and their
derivatives, not elsewhere specified or
included; hide powder,
whether or not chromed

CN code

2302 40 08

3504 00 00