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Document 02011D0884-20130704
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)
Consolidated text: 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)
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)
02011D0884 — EN — 04.07.2013 — 001.001
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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) (OJ L 343 23.12.2011, p. 140) |
Amended by:
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Official Journal |
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No |
page |
date |
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L 162 |
10 |
14.6.2013 |
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)
Article 1
Scope
Article 2
Definitions
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 representative portion thereof. |
Article 3
Prior notification
Article 4
Import conditions
Article 5
Official controls
After completion of the checks provided for in paragraphs 1 to 4, the competent authority shall:
complete the relevant part of Part II of the CED or, where appropriate, the CVED; and the responsible official of the competent authority shall stamp and sign the original of that document.
The CED or, where appropriate the CVED, can be completed only when the result of the analysis referred to in paragraph 3 is available;
make and retain a copy of the signed and stamped CED or, where appropriate, CVED.
The original of the CED or, where appropriate, the CVED shall accompany the consignment on its onward transport until it reaches its destination as indicated in the CED or the CVED.
Article 6
Reporting to the Commission
Those reports shall be submitted to the Commission during the month following each three-month period, in April, July, October, and January.
The report shall include the following information:
the number of consignments subjected to sampling for analysis;
the results of the checks as provided for in Article 5;
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
Until 5 August 2013, Member States shall authorise the imports of consignments of products referred to in Article 1(1) with the exception of the products of Annex I corresponding to Combined Nomenclature Codes 1905 90 60 , 1905 90 90 and 2103 90 90 , which have physically arrived in the Union before 4 July 2013, even if the CED has not been transmitted to the competent authority at least one working day prior to the physical arrival of the consignment as required by Article 3(2), provided that the other requirements set out in Article 3 are met.
Until 5 October 2013, Member States shall authorise the imports of consignments of products corresponding in Annex I to Combined Nomenclature Codes 1905 90 60 , 1905 90 90 and 2103 90 90 , which do not meet the conditions referred to in Articles 3 and 4, provided that the competent authority has conducted sampling and analysis in accordance with Article 5(3).
Article 10
Review of the measure
The measures provided for in this Decision shall be reviewed regularly to take into account, where appropriate, new developments as regards the presence of unauthorised GMOs in products originating in or consigned from China, or as regards scientific and technical progress in the methods for sampling and analysis provided in this Decision.
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.
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 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 |
Rice paper |
ex 1905 90 20 |
Biscuits |
1905 90 45 |
Extruded or expanded products, savoury or salted |
1905 90 55 |
Extruded or expanded products, sweetened (e.g. Fruit tarts, currant bread, panettone, meringues, Christmas stollen, croissants, and other baker’s wares) |
1905 90 60 |
Extruded or expanded products neither sweetened nor savouried nor salted (e.g. Pizzas, quiches and other unsweetened baker’s wares) |
1905 90 90 |
Sauces and preparations, mixed condiments and mixed seasonings |
2103 90 90 |
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 |
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 ►M1 CEN/TS 15568:2007 ◄ 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 ( 9 ), 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). 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.
For processed products such as flour, pasta or starch one analytical sample of 125 g shall be prepared from the homogenised laboratory sample. This analytical sample shall be ground, and from this sample two extractions shall be made with one PCR test for each GM genetic element for each extraction in accordance with the screening methods detailed under point 4.
The consignment shall be considered as non-compliant if at least one GM genetic element is detected in at least one analytical sample of the consignment according to the guidelines provided in the European Union Reference Laboratory for GMOs (EURL for GMOs) 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 ►M1 the EURL for GMOs ◄ . |
ANNEX III
MODEL OF HEALTH CERTIFICATE
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 (*1) |
|
Test report identification code (*1) |
<<000>> |
Laboratory sample identification code (*1) |
<<000>> |
Size of laboratory sample (*1) |
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 (*1) |
X test portions of Y mg |
Total DNA amount analysed (*1) |
X ng/PCR |
DNA sequence(s) tested for (*1): |
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 (*1) |
Source and nature of the positive control and reference materials (e.g. plasmid, genomic DNA, CRM …) |
Information on the positive control (*1) |
Please indicate the amount (in ng DNA) of positive control analysed and the average Ct number obtained |
Comments |
|
(*1)
Obligatory fields |
( 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.
( 4 ) OJ L 348, 24.11.2004, p. 18.
( 5 ) OJ L 54, 26.2.2009, p. 1.
( 6 ) OJ L 165, 30.4.2004, p. 1.
( 7 ) OJ L 194, 25.7.2009, p. 11.
( 8 ) OJ L 21, 28.1.2004, p. 11.
( 9 ) http://gmo-crl.jrc.ec.europa.eu