HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 343/140
EN
Official Journal of the European Union
23.12.2011
COMMISSION IMPLEMENTING DECISION
of 22 December 2011
on emergency measures regarding unauthorised genetically modified rice in rice products
originating from China and repealing Decision 2008/289/EC
(Text with EEA relevance)
(2011/884/EU)
THE EUROPEAN COMMISSION,
(3) Considering the continuing alerts and the lack of
sufficient guarantees from the Chinese competent
authorities concerning the absence of the unauthorised
genetically modified rice Bt 63 in products originating in
Having regard to the Treaty on the Functioning of the European
or consigned from China, Commission Decision
Union,
2008/289/EC ( 3 ) was adopted which introduced
emergency measures regarding the unauthorised GMO
Bt 63 in rice products. That Decision required that
prior to placing on the market, operators should
Having regard to Regulation (EC) No 178/2002 of the European
submit an analytical report to the relevant Member
Parliament and of the Council of 28 January 2002 laying down
State competent authorities demonstrating that the
the general principles and requirements of food law, establishing
consignment of rice products was not contaminated
the European Food Safety Authority and laying down
with genetically modified rice Bt 63. Additionally, that
procedures in matters of food safety (
Decision provided for Member States to take appropriate

1 ), and in particular
Article 53(1) thereof,
measures, including random sampling and analysis
carried out using a specific method described therein,
concerning products presented for importation or
already on the market.
Whereas:
(4) In
March
2010,
Germany
notified
the
RASFF
with
regard
to the presence of new rice varieties carrying unauth
(1) Articles
4(2)
and
16(2)
of
Regulation
(EC)
No
1829/2003
orised genetic elements encoding insect resistance
of the European Parliament and of the Council of
which had characteristics similar to the GMO Kefeng 6.
22 September 2003 on genetically modified food and
Subsequently, several additional similar alerts were
feed ( 2 ) provide that no genetically modified food or
notified, which in addition to Kefeng 6, also included
feed is to be placed on the Union market unless it is
the presence of another insect resistant rice line which
covered by an authorisation granted in accordance with
contained genetic elements similar to the GMO
that Regulation. Articles 4(3) and 16(3) of the same
Kemingdao 1 (KMD1). Kefeng 6 and KMD1 are not auth
Regulation lay down that no genetically modified food
orised either in the Union or China.
and feed may be authorised unless it has been adequately
and sufficiently demonstrated that it does not have
adverse effects on human health, animal health or the
environment, that it does not mislead the consumer or
(5) All
RASFF
notifications
were
notified
to
the
relevant
the user, and that it does not differ from the food or feed
Chinese authorities and additionally the Commission
it is intended to replace to such an extent that its normal
wrote to the authorities both in June 2010 and
consumption would be nutritionally disadvantageous for
February 2011 requesting action to address the
humans or animals.
increasing number of alerts.
(2) In
September
2006,
rice
products
originating
in
or (6) The
Food
and
Veterinary
Office
conducted
an
inspection
consigned from China, contaminated with the unauth
in China in October 2008 with the objective of
orised genetically modified rice Bt 63, were discovered
evaluating the implementation of Decision 2008/289/EC,
in the United Kingdom, France and Germany and were
which was subsequently followed up with another
notified to the Rapid Alert System for Food and Feed
mission in March 2011. The conclusions of the 2008
(RASFF). Notwithstanding the measures announced by
mission and the initial findings of the 2011 mission
the Chinese authorities to control the presence of that
indicated uncertainty as to the level, type and number
unauthorised Genetically Modified Organism (GMO),
of genetically modified rice varieties which may have
several other alerts concerning the presence of the
contaminated rice products originating in or consigned
unauthorised genetically modified rice Bt 63 were
from China, and that therefore there was a high risk of
subsequently reported.
further introductions of unauthorised GMOs in such rice
products.
( 1 ) OJ L 31, 1.2.2002, p. 1.
( 2 ) OJ L 268, 18.10.2003, p. 1.
( 3 ) OJ L 96, 9.4.2008, p. 29.

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23.12.2011 Official
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(7)
In light of the findings of the 2008 and 2011 missions
methods are qualitative and should address the detection
of the Food and Veterinary Office, and the numerous
of a unauthorised GMO for which there is no tolerance
RASFF notifications concerning unauthorised genetically
threshold for sampling and analysis.
modified rice events, the measures provided by Decision
2008/289/EC should be enhanced accordingly so as to
prevent any contaminated product being placed on the
Union market. Therefore it is necessary to replace
(12) The European Reference Laboratory for Genetically
Decision 2008/289/EC by means of this Decision.
Modified Food and Feed (EU-RL GMFF) within the Joint
Research Centre (JRC) verified and confirmed the suit
ability of the proposed screening methods for the
detection of genetically modified rice.
(8) Taking
into
account
the
fact
that
no
genetically
modified
rice products are authorised in the Union, it is appro
priate to extend the scope of measures provided for by
Decision 2008/289/EC, which is limited to genetically
(13) For the purpose of the sampling and detecting activities
modified rice Bt 63, and to broaden it to all genetically
required in order to prevent that products containing
modified organisms found in rice products originating in
unauthorised rice events are placed on the market, it is
or consigned from China. The obligation to provide an
necessary that both operators and official services follow
analytical report on sampling and analysis demonstrating
such methods of sampling and analysis provided for in
the absence of genetically modified rice events, estab
Annex II. In particular it is necessary that account is
lished by Decision 2008/289/EC, should be maintained.
taken of the guidance provided by the EU-RL GMFF
However, it is appropriate to reinforce Member State
concerning the application of these methods.
controls through enhanced frequency of sampling and
analysis which should be set at 100
% of all
consignments of rice products originating from China,
and to introduce the obligation for food and feed
(14) Rice products, as listed in Annex I, originating in or
operators to give prior notification of the estimated
consigned from China, should be released for free circu
date, time and place of the physical arrival of the
lation only if they are accompanied by an analytical
consignment.
report and health certificate issued by the Entry Exit
Inspection and Quarantine Bureau of the People’s
Republic of China (AQSIQ) in accordance with the
models laid down in Annex III and IV to this Decision.
(9) Sampling
methodologies
play
a
crucial
role
in
obtaining
representative and comparable results; it is therefore
appropriate to define a common protocol for sampling
and analysis for the control of the absence of genetically
(15) In order to be able to have a continuous assessment of
modified rice in imports originating from China. The
the control measures, it is appropriate to introduce an
principles for reliable sampling procedures for bulk agri
obligation for Member States to report regularly to the
cultural commodities are laid down in Commission
Commission concerning official controls on
Recommendation 2004/787/EC of 4 October 2004 on
consignments of rice products originating or consigned
technical guidance for sampling and detection of
from China.
genetically modified organisms and material produced
from genetically modified organisms as or in products
in the context of Regulation (EC) No 1830/2003 ( 1 ) and
for prepacked food in CEN/TS 15568 or equivalent. With
(16) The
measures
provided
for
in
this
Decision
should
be
regard to feed, such principles laid down in Commission
proportionate and no more restrictive of trade than is
Regulation (EC) No 152/2009 of 27 January 2009 laying
required and should therefore cover only products orig
down the methods of sampling and analysis for the
inating in or consigned from China and considered likely
official control of feed ( 2 ) shall apply.
to be contaminated with unauthorised genetically
modified rice events. Given the range of products that
could be contaminated with such unauthorised
(10) Due
to
the
number
of
potential
genetically
modified
rice
genetically modified rice events, it seems appropriate to
events, the lack of validated detection methods and
target all food and feed products which have rice listed as
control samples of adequate quality and quantity, and
an ingredient. Some products, however, may or may not
in order to facilitate controls, it is appropriate to
be containing, consisting or produced from rice. It seems
replace the method for sampling and analysis provided
therefore proportionate to allow operators to issue a
for in the Decision 2008/289/EC with the analytical
simple declaration when the product is not containing,
screening methods provided in Annex II.
consisting or produced from rice, thus avoiding the
compulsory analysis and certification.
(11) The
new
proposed
screening
methods
for
analysis
should
be based on Recommendation 2004/787/EC. It
(17) The
situation
concerning
the
possible
contamination
of
particularly takes into account that currently available
rice product with unauthorised genetically modified rice
lines should be reviewed within 6 months in order to
( 1 ) OJ L 348, 24.11.2004, p. 18.
assess whether the measures provided for in this Decision
( 2 ) OJ L 54, 26.2.2009, p. 1.
are still necessary.

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(18) The
measures provided for in this Decision are in
consignment and of the nature of the consignment. Operators
accordance with the opinion of the Standing
must also indicate the designation of the product as to whether
Committee on the Food Chain and Animal Health,
it is food or feed.
HAS ADOPTED THIS DECISION:
Article 4
Import conditions
Article 1
1. Each
consignment
of
products
referred
to
in
Article
1
Scope
shall be accompanied by an analytical report for each lot, and
This Decision shall apply to rice products listed in Annex I,
by a health certificate in accordance with the models set out in
originating in or consigned from China.
Annexes III and IV, completed, signed and verified by an auth
orised representative of the ‘Entry Exit Inspection and Quar
antine Bureau of the People’s Republic of China’ (AQSIQ).
Article 2
Definitions
1. For the purposes of this Decision, the definitions laid
2. Where
a
product
referred
to
in
Annex
I
is
not
containing,
down in Articles 2 and 3 of Regulation (EC) No 178/2002,
consisting of or produced from rice, the analytical report and
Article 2 of Regulation (EC) No 882/2004 of the European
the health certificate may be replaced by a statement from the
Parliament and of the Council of 29 April 2004 on official
operator responsible for the consignment indicating that the
controls performed to ensure the verification of compliance
food or feed is not containing, consisting or produced from
with feed and food law, animal health and animal welfare
rice.
rules ( 1 ) and Article 3(b) and (c) of Commission Regulation
(EC) No 669/2009 ( 2 ) on increased controls on imports of
certain feed and food of non-animal origin shall apply.
3. Sampling
and
analysis
for
the
purposes
of
the
analytical
report referred to in paragraph 1 shall be performed in
2. The following definitions shall also apply:
accordance with Annex II.
(a) Lot: a distinct and specified quantity of material.
4. Each consignment shall be identified with the code
appearing on the health certificate. Each individual bag, or
other packaging form, of the consignment shall be identified
(b) Increment sample: small equal quantity of product taken from
with that code.
each individual sampling point in the lot through the full
depth of the lot (static sampling), or taken from the product
stream during a stated portion of time (flowing
commodities sampling).
Article 5
Official controls
(c) Bulk sample: quantity of product obtained by combining and
mixing the increments taken from a specific lot.
1. The
competent
authority
of
a
Member
State
shall
ensure
that all the products referred to in Article 1 are subject to
documentary checks to ensure that the import conditions
provided for in Article 4 are complied with.
(d) Laboratory sample: quantity of product taken from the bulk
sample intended for laboratory inspection and testing.
2. Where
a
consignment
of
products
other
than
those
(e) Analytical sample: homogenised laboratory sample,
described in Article 4(2) is not accompanied by a health
consisting either of the whole laboratory sample or a repre
certificate and the analytical report provided for in Article 4,
sentative portion thereof.
the consignment shall be re-dispatched to the country of origin
or destroyed.
Article 3
Prior notification
3. Where
a
consignment
is
accompanied
by
the
health
Feed and food business operators or their representatives shall
certificate and the analytical report provided for in Article 4
give adequate prior notification of the estimated date and time
the competent authority shall take a sample for analysis in
at the designated point of entry of the physical arrival of the
accordance with Annex II for the presence of unauthorised
GMOs with a frequency of 100 %. If the consignment
( 1 ) OJ L 165, 30.4.2004, p. 1.
consists of several lots, each lot shall be submitted to
( 2 ) OJ L 194, 25.7.2009, p. 11.
sampling and analysis.

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4. The
competent
authority
may
authorise
onward
transpor
Article 8
tation of the consignment pending the results of the physical
checks. In such a case the consignment shall remain under the
Costs
continuous control of the competent authorities pending the
All costs resulting from the official controls including sampling,
results of the physical checks.
analysis, storage and any measures taken following non-
compliance, shall be borne by the food and feed business
operators.
5. The
release
for
free
circulation
of
consignments
shall
only
be allowed when, following sampling and analyses performed in
accordance with Annex II, all lots of that consignment are
Article 9
considered compliant with Union Law.
Transitional provisions
Article 6
By way of derogation from Article 4(1), Member States shall
authorise the imports of consignments of products referred to
Reporting to the Commission
in Article 1 which left China prior to 1st of February 2012
provided that sampling and analysis has been conducted in
1. Member
States
shall
prepare
a
report
every
3
months, accordance with the Article 4.
giving an account of all the results of all analytical tests
carried out in the previous 3 months on consignments of the
products referred to in Article 1.
Article 10
Review of the measure
Those reports shall be submitted to the Commission during the
month following each three-month period, in April, July,
The measures provided for in this Decision shall be reviewed by
October, and January.
the 6 months following adoption at the latest.
2. The
report
shall
include
the
following
information:
Article 11
Repeal
(a) the number of consignments subjected to sampling for
Decision 2008/289/EC is hereby repealed.
analysis;
References to the repealed Decision shall be construed as
(b) the results of the checks as provided for in Article 5;
references to this Decision.
(c) the number of consignments which have been rejected due
Article 12
to the absence of a health certificate or an analytical report.
Entry into force
Article 7
This Decision shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.
Splitting of a consignment
Consignments shall not be split until all official controls have
Done at Brussels, 22 December 2011.
been completed by the competent authorities.
For the Commission
In the case of subsequent splitting following official control, an
authenticated copy of the health certificate and the analytical
The President
report shall accompany each part of the split consignment.
José Manuel BARROSO

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ANNEX I
LIST OF PRODUCTS
Product CN
code
Rice in the husk (‘paddy’ or rough) 1006
10
Husked (brown) rice
1006 20
Semi-milled or wholly milled rice, whether or not polished or glazed 1006
30
Broken rice
1006 40 00
Rice flour
1102 90 50
Rice groats and meal
1103 19 50
Rice pellets
1103 20 50
Flaked rice grains
1104 19 91
Rolled or flaked cereal grains (excluding grains of oats, wheat, rye, maize and barley, and
1104 19 99
flaked rice)
Rice starch
1108 19 10
Preparations for infant use, put up for retail sale 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 1902
19
Stuffed pasta, whether or not cooked or otherwise prepared 1902
20
Other pasta (other than uncooked pasta, not stuffed or otherwise prepared, and other than
1902 30
stuffed pasta, whether or not cooked or otherwise prepared)
Prepared foods obtained by swelling or roasting cereals or cereal products, obtained from
1904 10 30
rice
Preparations of the muesli-type based on unroasted cereal flakes 1904
20
10
Prepared foods obtained from unroasted cereal flakes or from mixtures of unroasted cereal
1904 20 95
flakes and roasted cereal flakes or swelled cereals, obtained from rice (excluding prep
arations of the muesli-type on the basis of unroasted cereal flakes)
Rice, pre-cooked or otherwise prepared, not elsewhere specified or included (excluding
1904 90 10
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
ex 1905 90 20
Biscuits
1905 90 45
Extruded or expanded products, savoury or salted 1905
90
55
Bran, sharps and other residues, whether or not in the form of pellets, derived from the
2302 40 02
sifting, milling or other working of rice with a starch content not exceeding 35 % by weight
Bran, sharps and other residues, whether or not in the form of pellets, derived from the
2302 40 08
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
3504 00 00
specified or included; hide powder, whether or not chromed

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ANNEX II
Methods of sampling and analysis for official control regarding unauthorised genetically modified organism in
rice products originating from China
1. General
provisions
Samples intended for the official control for the absence of GM rice in rice products shall be taken according to the
methods described in this Annex. The bulk samples thus obtained shall be considered as representative of the lots
from which they are taken.
2. Sampling
2.1. Sampling lots of bulk commodities and preparation of the analytical samples
The number of incremental samples which make up the bulk sample and the preparation of the analytical samples
shall be made in accordance with Recommendation 2004/787/EC and Regulation (EC) No 152/2009 for feed. The
size of the laboratory sample shall be 2,5 kg but may be reduced to 500 grams for processed food or feed. For the
purpose of Article 11(5) of Regulation (EC) No 882/2004, a second laboratory sample shall be constituted from the
bulk sample.
2.2. Sampling of prepacked food and feed
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 CEN/ISO 15568 or equivalent. The size of the laboratory sample shall be
2,5 kg but may be reduced to 500 grams for processed food or feed. For the purpose of Article 11(5) of Regulation
(EC) No 882/2004, a second laboratory sample shall be constituted from the bulk sample.
3. Analysis
of
the
laboratory
sample
The laboratory analysis at the point of origin shall be carried out in a designated AQSIQ laboratory, and prior to
release for free circulation in the Union in a Member State designated official control laboratory. Screening tests shall
be performed by real-time PCR according to the method published by the EU-RL GMFF ( 1 ), for at least the following
genetic elements: the CAMV (Cauliflower Mosaic Virus) 35S promoter, the NOS (nopaline synthase) terminator from
Agrobacterium tumefaciens and the engineered CryIAb, CryIAc and/or CryIAb/CryIAc from Bacillus thuringiensis.
In the case of grain samples the designated control laboratory shall take from the homogenised laboratory sample
four analytical samples of 240 grams (equivalent 10 000 rice grains). For processed products such as flour, pasta or
starch the analytical samples this may be reduced to 125 grams. The four analytical samples shall be ground and
further analysed separately. Two extractions shall be made from each analytical sample. One PCR test for each GM
genetic element shall be made for each extraction in accordance with the screening methods detailed under point 4
below. The consignment shall be considered non-compliant if at least one GM genetic element is considered
detectable in at least one analytical sample of the consignment according to the guidelines provided in the EU-
RL report.
4. The
following
analytical
methods
shall
be
used:
(a) For screening for the CAMV (Cauliflower Mosaic Virus) 35S promoter and the NOS (nopaline synthase)
terminator from Agrobacterium tumefaciens.
ISO 21570: 2005 Methods of analysis for the detection of genetically modified organisms and derived
products—quantitative nucleic acid based methods. Annex B1.
H.-U. Waiblinger et al., (2008) ‘Validation and collaborative study of a P35S and T-nos duplex real-time
screening method to detect genetically modified organisms in food products’ Eur. Food Res. and Technol.,
Volume 226, 1221-1228.
E. Barbau-Piednoir et al., (2010) ‘SYBRGreen qPCR screening methods for the presence of “35S promoter” and
“NOS terminator” elements in food and feed products’ Eur. Food Res. and Technol Volume 230, 383-393.
Reiting R, Broll H, Waiblinger HU, Grohmann L (2007) Collaborative study of a T-nos real-time PCR method for
screening of genetically modified organisms in food products. J Verbr Lebensm 2:116–121.
( 1 ) http://gmo-crl.jrc.ec.europa.eu

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(b) For screening for the engineered CryIAb, CryIAc and/or CryIAb/CryIAc from Bacillus thuringiensis.
E. Barbau-Piednoir et al., (in press) ‘Four new SYBRGreen qPCR screening methods for the detection of
Roundup Ready, LibertyLink and CryIAb traits in genetically modified products’ Eur. Food Res. and
Technol DOI 10.1007/s00217-011-1605-7.
Following verification of the specificity of the methods by the EU-RL GMFF on a wide variety of Chinese rice
samples such method shall be considered as appropriate for these screening purposes.
5. The application of the above screening methods shall take into consideration the guidance document published by
the EU RL GMFF.

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ANNEX III
MODEL OF HEALTH CERTIFICATE

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ANNEX IV
MODEL OF ANALYTICAL REPORT
Note: please compile an annex form for each sample tested
Parameter to be reported Information
provided
Name and address of the test laboratory (*)
Test report identification code (*) <<000>>
Laboratory sample identification code (*) <<000>>
Size of laboratory sample (*) X
kg
In case of sample division:
X analytical samples of Y g
Number and size of analytical samples
Number and size of test portions analysed (*) X
test
portions
of
Y
mg
Total DNA amount analysed (*) X
ng/PCR
For each of the following provide reference to the method
used and the average Ct number obtained
Rice marker:
DNA sequence(s) tested for (*):
35S promoter:
NOS terminator:
CryIAb/CryIAc:
Validation status: (e.g. inter-laboratory validated, in-house
validated [please indicate according to which standard,
guideline])
Description of DNA sequences detected (reference + target
genes):
Other sequence(s) tested for:
Specificity of the method (screening, construct-specific or
event-specific):
Absolute Limit of Detection (copy number):
Practical Limit of Detection (LOD related to the sample
analysed), if determined:
Description of positive controls for target DNA, and Source and nature of the positive control and reference
reference materials (*)
materials (e.g. plasmid, genomic DNA, CRM …)
Information on the positive control (*)
Please indicate the amount (in ng DNA) of positive control
analysed and the average Ct number obtained
Comments
(*) Obligatory fields

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