2006D0601 — EN — 07.11.2006 — 001.001

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►B COMMISSION DECISION of 5 September 2006 on emergency measures regarding the non-authorised genetically modified organism ‘LL RICE 601’ in rice products (notified under document number C(2006) 3932) (Text with EEA relevance) (2006/601/EC) (OJ L 244, 7.9.2006, p.27)

Amended by:

Official Journal No page date ►M1 COMMISSION DECISION of 6 November 2006 L 306 17 7.11.2006









▼B

COMMISSION DECISION

of 5 September 2006

on emergency measures regarding the non-authorised genetically modified organism ‘LL RICE 601’ in rice products

(notified under document number C(2006) 3932)

(Text with EEA relevance)

(2006/601/EC)







THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, 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(2), second subparagraph, thereof, Whereas: (1) Article 4(2) and Article 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 provide that no genetically modified food or feed ( 2 ) is to be placed on the Community market unless it is covered by an authorisation granted in accordance with that Regulation. Article 4(3) and Article 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) On 18 August 2006, the authorities of the United States of America informed the Commission that rice products contaminated with the genetically modified rice ‘LL RICE 601’ (‘the contaminated products’), which have not been authorised for placing on the market in the Community, had been found in rice samples taken on the US market from commercial long-grain rice from the 2005 crop. The contamination of products was reported to the US authorities on 31 July 2006 by Bayer Crop Science, which is the company that developed the genetically modified rice ‘LL RICE 601’. The US authorities later informed the Commission that it is still not known to what extent the supply chain has been contaminated and that information on possible contamination of exports to the Community cannot be given at present. In addition, they informed the Commission that those products had not been authorised for placing on the market in the United States either. (3) Without prejudice to the control obligations of the Member States, the measures to be adopted further to the likely imports of contaminated products should form a comprehensive and common approach allowing rapid and effective action to be taken and avoiding disparities between the treatment of the situation by the various Member States. (4) Article 53 of Regulation (EC) No 178/2002 provides for the possibility to adopt appropriate Community emergency measures for food and feed imported from a third country in order to protect human health, animal health or the environment, where the risk cannot be contained satisfactorily by means of measures taken by the Member States concerned. (5) Since genetically modified rice ‘LL RICE 601’ is not authorised under Community legislation and in view of the presumption of risk on products not authorised according to Regulation (EC) No 1829/2003, which takes into account the precautionary principle laid down in Article 7 of Regulation (EC) No 178/2002, it is appropriate to take emergency measures to prevent the placing on the market in the Community of the contaminated products. (6) According to the general requirements laid down in Regulation (EC) No 178/2002, food and feed business operators have primary legal responsibility for ensuring that foods or feeds within the businesses under their control satisfy the requirements of food law and for verifying that such requirements are met. It is, therefore, the operators responsible for first placing food and feed on the market who should be under the duty to prove that they do not contain the contaminated products. To this end, the measures provided for in this Decision should require that consignments of specific products originating from the United States may be placed on the market only if an analytical report demonstrating that the products are not contaminated with ‘LL RICE 601’ is provided. The analytical report should be issued by an accredited laboratory conforming to internationally recognised standards. (7) In order to facilitate controls, all genetically modified food and feed placed on the market should be subject to a validated method of detection. Bayer Crop Science has been requested to provide methods for detection of ‘LL RICE 601’ as well as control samples. It has made available two methods which have been validated by the Grain Inspection, Packers and Stockyards Administration (GIPSA) of the US Department of Agriculture, in collaboration with the Community reference laboratory referred to in Article 32 of Regulation (EC) No 1829/2003. (8) The measures provided for in this Decision must be proportionate and no more restrictive of trade than is required and should therefore cover only products considered likely to be contaminated with ‘LL RICE 601’, which according to the information received, are imported from the United States into the Community. (9) Despite requests made by the Commission, the US authorities have been unable to provide any guarantee that rice products imported from the United States will not contain ‘LL RICE 601’. (10) With regard to feed products or other food products not covered by the measures provided for in this Decision, Member States should monitor whether such products have been contaminated by ‘LL RICE 601’. On the basis of the information provided by Member States, the Commission will consider the need for any additional appropriate measures. (11) Commission Decision 2006/578/EC of 23 August 2006 on emergency measures regarding the non-authorised genetically modified organism LL RICE 601 in rice products ( 3 ) was adopted to ban provisionally the placing on the market of contaminated products. (12) Those provisional measures should be confirmed. (13) It is therefore appropriate to repeal and replace Decision 2006/578/EC. (14) The measures provided for in this Decision should be reviewed within six months in order to assess whether they are still necessary, (15) 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

This Decision applies to the following products originating from the United States of America:







Product CN Code rice in the husk, parboiled Long A 1006 10 25 rice in the husk parboiled Long B 1006 10 27 rice in the husk other than parboiled Long A 1006 10 96 rice in the husk other than parboiled Long B 1006 10 98 husked (brown) rice Parboiled Long A 1006 20 15 husked (brown) rice Parboiled Long B 1006 20 17 husked (brown) rice Long A 1006 20 96 husked (brown) rice Long B 1006 20 98 semi-milled Parboiled rice Long A 1006 30 25 semi-milled Parboiled rice Long B 1006 30 27 semi-milled rice Long A 1006 30 46 semi-milled rice Long B 1006 30 48 wholly milled Parboiled rice Long A 1006 30 65 wholly milled Parboiled rice Long B 1006 30 67 wholly milled rice Long A 1006 30 96 wholly milled rice Long B 1006 30 98 broken rice (unless it is certified as not obtained from Long-grain) 1006 40 00

Article 2

Conditions for first placing on the market

1. Member States shall allow the first placing on the market of the products referred to in Article 1 only if the consignment of those products is accompanied by the original of an analytical report confirming that the products do not contain the genetically modified rice ‘LL RICE 601’. That report shall be issued by an accredited laboratory and based on a suitable and validated method for detection of genetically modified rice ‘LL RICE 601’.

2. Member States shall ensure that, at the point of entry into the Community, official sampling and analysis of each consignment of products referred to in Article 1 is carried out before they are placed on the Community market to demonstrate that it does not contain genetically modified rice ‘LL RICE 601’. For that purpose official sampling and analysis shall be carried out in accordance with the methods described in the Annex and within a maximum period of 15 working days.

3. The competent authorities of the Member States referred to in paragraph 2 shall issue an official accompanying document indicating that the consignment has been subject to official sampling and analysis and setting out the result of the analysis.

4. If a consignment is split, copies of the original analytical report as referred to in paragraph 1 and of the official accompanying document as referred to in paragraph 3 shall accompany each part of the split consignment up to and including the wholesale stage. Those copies shall be certified by the competent authority of the Member State on whose territory the splitting has taken place.

5. Any presence of genetically modified rice ‘LL RICE’ 601 detected by the controls provided for in paragraph 2 shall be reported to the Commission and the Member States through the Rapid Alert System for food and feed established by Article 50 of Regulation (EC) No 178/2002.

6. Member States shall by 31 December 2006 at the latest submit to the Commission a report of all analytical results of official controls on consignments of products referred to in Article 1.

Article 3

Other control measures

Member States shall take appropriate measures, including random sampling and analysis carried out in accordance with the Annex, concerning the products referred to in Article 1 already on the market in order to verify the absence of genetically modified rice ‘LL RICE 601’. They shall inform the Commission of positive (unfavourable) results through the Rapid Alert System for food and feed.

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Article 4

Contaminated consignments

Member States shall take the necessary measures to ensure that the products referred to in Article 1 that are found to contain genetically modified rice ‘LL RICE 601’ are not placed on the market.

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Article 5

Recovery of costs

1. All costs resulting from sampling, analysis, storage and issuing of official accompanying documents and of copies of analytical reports and accompanying documents pursuant to Article 2(1) to (4) shall be borne by the food business operator responsible for the consignment or its representative.

2. All costs related to official measures taken by the competent authorities as regards non-compliant consignments shall be borne by the food business operator responsible for the consignment or its representative.

Article 6

Review of the measures

The measures provided for in this Decision shall be reviewed by 15 January 2007 at the latest.

▼B

Article 7

Repeal

Decision 2006/578/EC is repealed.

Article 8

Addressees

This Decision is addressed to the Member States.