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,  
Having regard to the Treaty on the Functioning of the European 
Union,  
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 
procedures in matters of food safety (  1 ), and in particular 
Article 53(1) thereof,  
Whereas:  
(1) Articles 4(2) and 16(2) of Regulation (EC) No 1829/2003 
of the European Parliament and 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 Union market unless it is 
covered by an authorisation granted in accordance with 
that Regulation. Articles 4(3) and 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 demonstrated 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.  
(2) In September 2006, rice products originating in or 
consigned from China, contaminated with the unauth ­
orised genetically modified rice Bt 63, were discovered 
in the United Kingdom, France and Germany and were 
notified to the Rapid Alert System for Food and Feed 
(RASFF). Notwithstanding the measures announced by 
the Chinese authorities to control the presence of that 
unauthorised Genetically Modified Organism (GMO), 
several other alerts concerning the presence of the 
unauthorised genetically modified rice Bt 63 were 
subsequently reported.  (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 
or consigned from China, Commission Decision 
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 
submit an analytical report to the relevant Member 
State competent authorities demonstrating that the 
consignment of rice products was not contaminated 
with genetically modified rice Bt 63. Additionally, that 
Decision provided for Member States to take appropriate 
measures, including random sampling and analysis 
carried out using a specific method described therein, 
concerning products presented for importation or 
already on the market.  
(4) In March 2010, Germany notified the RASFF with regard 
to the presence of new rice varieties carrying unauth ­
orised genetic elements encoding insect resistance 
which had characteristics similar to the GMO Kefeng 6. 
Subsequently, several additional similar alerts were 
notified, which in addition to Kefeng 6, also included 
the presence of another insect resistant rice line which 
contained genetic elements similar to the GMO 
Kemingdao 1 (KMD1). Kefeng 6 and KMD1 are not auth ­
orised either in the Union or China.  
(5) All RASFF notifications were notified to the relevant 
Chinese authorities and additionally the Commission 
wrote to the authorities both in June 2010 and 
February 2011 requesting action to address the 
increasing number of alerts.  
(6) The Food and Veterinary Office conducted an inspection 
in China in October 2008 with the objective of 
evaluating the implementation of Decision 2008/289/EC, 
which was subsequently followed up with another 
mission in March 2011. The conclusions of the 2008 
mission and the initial findings of the 2011 mission 
indicated uncertainty as to the level, type and number 
of genetically modified rice varieties which may have 
contaminated rice products originating in or consigned 
from China, and that therefore there was a high risk of 
further introductions of unauthorised GMOs in such rice 
products.EN L 343/140 Official Journal of the European Union 23.12.2011  
( 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.(7) In light of the findings of the 2008 and 2011 missions 
of the Food and Veterinary Office, and the numerous 
RASFF notifications concerning unauthorised genetically 
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 
Decision 2008/289/EC by means of this Decision.  
(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 
modified rice Bt 63, and to broaden it to all genetically 
modified organisms found in rice products originating in 
or consigned from China. The obligation to provide an 
analytical report on sampling and analysis demonstrating 
the absence of genetically modified rice events, estab ­
lished by Decision 2008/289/EC, should be maintained. 
However, it is appropriate to reinforce Member State 
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 
operators to give prior notification of the estimated 
date, time and place of the physical arrival of the 
consignment.  
(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 
modified rice in imports originating from China. The 
principles for reliable sampling procedures for bulk agri ­
cultural commodities are laid down in 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 (  1 ) and 
for prepacked food in CEN/TS 15568 or equivalent. With 
regard to feed, such principles laid down in Commission 
Regulation (EC) No 152/2009 of 27 January 2009 laying 
down the methods of sampling and analysis for the 
official control of feed (  2 ) shall apply.  
(10) Due to the number of potential genetically modified rice 
events, the lack of validated detection methods and 
control samples of adequate quality and quantity, and 
in order to facilitate controls, it is appropriate to 
replace the method for sampling and analysis provided 
for in the Decision 2008/289/EC with the analytical 
screening methods provided in Annex II.  
(11) The new proposed screening methods for analysis should 
be based on Recommendation 2004/787/EC. It 
particularly takes into account that currently available methods are qualitative and should address the detection 
of a unauthorised GMO for which there is no tolerance 
threshold for sampling and analysis.  
(12) The European Reference Laboratory for Genetically 
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.  
(13) For the purpose of the sampling and detecting activities 
required in order to prevent that products containing 
unauthorised rice events are placed on the market, it is 
necessary that both operators and official services follow 
such methods of sampling and analysis provided for in 
Annex II. In particular it is necessary that account is 
taken of the guidance provided by the EU-RL GMFF 
concerning the application of these methods.  
(14) Rice products, as listed in Annex I, originating in or 
consigned from China, should be released for free circu ­
lation only if they are accompanied by an analytical 
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.  
(15) In order to be able to have a continuous assessment of 
the control measures, it is appropriate to introduce an 
obligation for Member States to report regularly to the 
Commission concerning official controls on 
consignments of rice products originating or consigned 
from China.  
(16) The measures provided for in this Decision should be 
proportionate and no more restrictive of trade than is 
required and should therefore cover only products orig ­
inating in or consigned from China and considered likely 
to be contaminated with unauthorised genetically 
modified rice events. Given the range of products that 
could be contaminated with such unauthorised 
genetically modified rice events, it seems appropriate to 
target all food and feed products which have rice listed as 
an ingredient. Some products, however, may or may not 
be containing, consisting or produced from rice. It seems 
therefore proportionate to allow operators to issue a 
simple declaration when the product is not containing, 
consisting or produced from rice, thus avoiding the 
compulsory analysis and certification.  
(17) The situation concerning the possible contamination of 
rice product with unauthorised genetically modified rice 
lines should be reviewed within 6 months in order to 
assess whether the measures provided for in this Decision 
are still necessary.EN 23.12.2011 Official Journal of the European Union L 343/141  
( 1 ) OJ L 348, 24.11.2004, p. 18.  
( 2 ) OJ L 54, 26.2.2009, p. 1.(18) The measures provided for in this Decision are in 
accordance with the opinion of the Standing 
Committee on the Food Chain and Animal Health,  
HAS ADOPTED THIS DECISION:  
Article 1  
Scope  
This Decision shall apply to rice products listed in Annex I, 
originating in or consigned from China.  
Article 2  
Definitions  
1. For the purposes of this Decision, the definitions laid 
down in Articles 2 and 3 of Regulation (EC) No 178/2002, 
Article 2 of Regulation (EC) No 882/2004 of the European 
Parliament and of the Council of 29 April 2004 on official 
controls performed to ensure the verification of compliance 
with feed and food law, animal health and animal welfare 
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.  
2. The following definitions shall also apply:  
(a) Lot:  a distinct and specified quantity of material.  
(b) Increment sample:  small equal quantity of product taken from 
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).  
(c) Bulk sample:  quantity of product obtained by combining and 
mixing the increments taken from a specific lot.  
(d) Laboratory sample:  quantity of product taken from the bulk 
sample intended for laboratory inspection and testing.  
(e) Analytical sample:  homogenised laboratory sample, 
consisting either of the whole laboratory sample or a repre ­
sentative portion thereof.  
Article 3  
Prior notification  
Feed and food business operators or their representatives shall 
give adequate prior notification of the estimated date and time 
at the designated point of entry of the physical arrival of the consignment and of the nature of the consignment. Operators 
must also indicate the designation of the product as to whether 
it is food or feed.  
Article 4  
Import conditions  
1. Each consignment of products referred to in Article 1 
shall be accompanied by an analytical report for each lot, and 
by a health certificate in accordance with the models set out in 
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).  
2. Where a product referred to in Annex I is not containing, 
consisting of or produced from rice, the analytical report and 
the health certificate may be replaced by a statement from the 
operator responsible for the consignment indicating that the 
food or feed is not containing, consisting or produced from 
rice.  
3. Sampling and analysis for the purposes of the analytical 
report referred to in paragraph 1 shall be performed in 
accordance with Annex II.  
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 
with that code.  
Article 5  
Official controls  
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.  
2. Where a consignment of products other than those 
described in Article 4(2) is not accompanied by a health 
certificate and the analytical report provided for in Article 4, 
the consignment shall be re-dispatched to the country of origin 
or destroyed.  
3. Where a consignment is accompanied by the health 
certificate and the analytical report provided for in Article 4 
the competent authority shall take a sample for analysis in 
accordance with Annex II for the presence of unauthorised 
GMOs with a frequency of 100 %. If the consignment 
consists of several lots, each lot shall be submitted to 
sampling and analysis.EN L 343/142 Official Journal of the European Union 23.12.2011  
( 1 ) OJ L 165, 30.4.2004, p. 1.  
( 2 ) OJ L 194, 25.7.2009, p. 11.4. The competent authority may authorise onward transpor ­
tation of the consignment pending the results of the physical 
checks. In such a case the consignment shall remain under the 
continuous control of the competent authorities pending the 
results of the physical checks.  
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 
considered compliant with Union Law.  
Article 6  
Reporting to the Commission  
1. Member States shall prepare a report every 3 months, 
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.  
Those reports shall be submitted to the Commission during the 
month following each three-month period, in April, July, 
October, and January.  
2. The report shall include the following information:  
(a) the number of consignments subjected to sampling for 
analysis;  
(b) the results of the checks as provided for in Article 5;  
(c) the number of consignments which have been rejected due 
to the absence of a health certificate or an analytical report.  
Article 7  
Splitting of a consignment  
Consignments shall not be split until all official controls have 
been completed by the competent authorities.  
In the case of subsequent splitting following official control, an 
authenticated copy of the health certificate and the analytical 
report shall accompany each part of the split consignment.  Article 8  
Costs  
All costs resulting from the official controls including sampling, 
analysis, storage and any measures taken following non- 
compliance, shall be borne by the food and feed business 
operators.  
Article 9  
Transitional provisions  
By way of derogation from Article 4(1), Member States shall 
authorise the imports of consignments of products referred to 
in Article 1 which left China prior to 1st of February 2012 
provided that sampling and analysis has been conducted in 
accordance with the Article 4.  
Article 10  
Review of the measure  
The measures provided for in this Decision shall be reviewed by 
the 6 months following adoption at the latest.  
Article 11  
Repeal  
Decision 2008/289/EC is hereby repealed.  
References to the repealed Decision shall be construed as 
references to this Decision.  
Article 12  
Entry into force  
This Decision shall enter into force on the 20th day following 
its publication in the  Official Journal of the European Union . 
Done at Brussels, 22 December 2011.  
For the Commission  
The President  
José Manuel BARROSOEN 23.12.2011 Official Journal of the European Union L 343/143ANNEX 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 
flaked rice)  1104 19 99  
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 
stuffed pasta, whether or not cooked or otherwise prepared)  1902 30  
Prepared foods obtained by swelling or roasting cereals or cereal products, obtained from 
rice 1904 10 30  
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 
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)  1904 20 95  
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)  1904 90 10  
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 
sifting, milling or other working of rice with a starch content not exceeding 35 % by weight  2302 40 02  
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  2302 40 08  
Peptones and their derivatives; other protein substances and their derivatives, not elsewhere 
specified or included; hide powder, whether or not chromed  3504 00 00EN L 343/144 Official Journal of the European Union 23.12.2011ANNEX 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) ‘SYBR®Green 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.EN 23.12.2011 Official Journal of the European Union L 343/145  
( 1 ) http://gmo-crl.jrc.ec.europa.eu(b) For screening for the engineered CryIAb, CryIAc and/or CryIAb/CryIAc from  Bacillus thuringiensis . 
E. Barbau-Piednoir  et al. , (in press) ‘Four new SYBR®Green 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.EN L 343/146 Official Journal of the European Union 23.12.2011ANNEX III  
MODEL OF HEALTH CERTIFICATE
EN 23.12.2011 Official Journal of the European Union L 343/147ANNEX 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: 
Number and size of analytical samples  X analytical samples of Y g  
Number and size of test portions analysed (*)  X test portions of Y mg  
Total DNA amount analysed (*)  X ng/PCR  
DNA sequence(s) tested for (*):  For each of the following provide reference to the method 
used and the average Ct number obtained 
Rice marker: 
35S promoter: 
NOS terminator: 
CryIAb/CryIAc:  
Other sequence(s) tested for:  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): 
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 
reference materials (*)  Source and nature of the positive control and reference 
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 fieldsEN L 343/148 Official Journal of the European Union 23.12.2011