2011D0884 — EN — 04.07.2013 — 001.001

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►B 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) (OJ L 343, 23.12.2011, p.140)

Amended by:

Official Journal No page date ►M1 COMMISSION IMPLEMENTING DECISION of 13 June 2013 L 162 10 14.6.2013









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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)

(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 unauthorised 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 unauthorised 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 authorised 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. (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 appropriate 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, established 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 agricultural 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 ( 4 ) 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 ( 5 ) 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 suitability 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 circulation 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 originating 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. (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, Whereas: HAS ADOPTED THIS DECISION:







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Article 1

Scope

1. The Decision shall apply to products originating in or consigned from China listed in Annex I.

2. Member States may carry out random physical checks in accordance with Annex II to this Decision on food and feed originating in or consigned from China other than those mentioned in paragraph 1 but which may consist, contain or be produced from rice, in order to ensure compliance with Articles 4(3) and 16(3) of Regulation (EC) No 1829/2003.

3. This Decision shall not apply to consignments of food and feed referred to in paragraph 1 which are destined to a private person for personal consumption and use only. In case of doubt, the burden of proof lies with the recipient of the consignment.

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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 ( 6 ) and Article 3(b) and (c) of Commission Regulation (EC) No 669/2009 ( 7 ) 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 representative portion thereof.

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Article 3

Prior notification

1. Feed and food business operators or their representatives shall give adequate prior notification of the estimated date and time of the physical arrival of the consignment and of the nature of the consignment to the competent authorities at the Border Inspection Post or at the Designated Point of Entry as appropriate. Operators shall also indicate the designation of the product as to whether it is food or feed.

2. For that purpose, they shall complete the relevant parts of the common entry document (CED) referred to in Annex II to Regulation (EC) No 669/2009, or the common veterinary entry document (CVED), as provided for in Article 2 of Commission Regulation (EC) No 136/2004 ( 8 ), and transmit that document to the competent authority at the Border Inspection Post or at the Designated Point of Entry as appropriate, at least one working day prior to the physical arrival of the consignment.

3. Paragraphs 1 and 2 shall not apply to products referred to in Annex I which are not containing, consisting or produced from rice.

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Article 4

Import conditions

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1. Each consignment of product 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). The analytical report and the health certificate shall be drawn up in an official language of the Member State of import, or in another language that the competent authorities of that Member State have decided to accept.

2. Where a product referred to in Annex I does not contain, consist of or is not 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 does not contain, consist or is produced from rice. This statement shall be drawn up in an official language of the Member State of import, or in another language that the competent authorities of that Member State have decided to accept.

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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.

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Article 5

Official controls

1. Each consignment of products referred to in Article 1 is 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. After completion of the checks provided for in paragraphs 1 to 4, the competent authority shall:

(a) 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;

(b) 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.

6. 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. This requirement also applies to consignments tested in accordance with Article 1(2).

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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.

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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.

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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.

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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 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 ex190590 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

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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 ►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.

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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.

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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