
Article 1 
This Decision shall apply to rice products listed in Annex I, originating in or consigned from China.
Article 2 

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 and Article 3(b) and (c) of Commission Regulation (EC) No 669/2009 on increased controls on imports of certain feed and food of non-animal origin shall apply.
2. The following definitions shall also apply:(a) Lota distinct and specified quantity of material.(b) Increment samplesmall 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 samplequantity of product obtained by combining and mixing the increments taken from a specific lot.(d) Laboratory samplequantity of product taken from the bulk sample intended for laboratory inspection and testing.(e) Analytical samplehomogenised laboratory sample, consisting either of the whole laboratory sample or a representative portion thereof.
Article 3 
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 

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 authorised representative of the ‘Entry Exit Inspection and Quarantine 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 

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.
4. The competent authority may authorise onward transportation 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 

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 
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 
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 
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 
The measures provided for in this Decision shall be reviewed by the 6 months following adoption at the latest.
Article 11 
Decision 2008/289/EC is hereby repealed.
References to the repealed Decision shall be construed as references to this Decision.
Article 12 
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 BARROSO
ANNEX I
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 preparations 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 00
ANNEX II
1. 
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.  2.1. 
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. 
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. 
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, 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.
((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.

ANNEX III

ANNEX IV
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 
