Legal provisions of COM(2006)78 - Placing on the market, in accordance with Directive 2001/18/EC, of oilseed rape products (Brassica napus L., lines Ms8, Rf3 and Ms8xRf3) genetically modified for tolerance to the herbicide glufosinate-ammonium

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dossier COM(2006)78 - Placing on the market, in accordance with Directive 2001/18/EC, of oilseed rape products (Brassica napus L., lines Ms8, Rf3 ...
document COM(2006)78 EN
date March 26, 2007

Contents

Article 1 - Consent

Without prejudice to other Community legislation, in particular Regulation (EC) No 258/97 and Regulation (EC) No 1829/2003, written consent shall be granted by the competent authority of Belgium to the placing on the market, in accordance with this Decision, of the products identified in Article 2, as notified by Bayer BioScience nv (Reference C/BE/96/01).

The consent shall, in accordance with Article 19(3) of Directive 2001/18/EC, explicitly specify the conditions to which the consent is subject, which are set out in Articles 3 and 4.

Article 2 - Products

1. The genetically modified organisms to be placed on the market as or in products, hereinafter ‘the products’, are grains of oilseed rape (Brassica napus L.) from the individual female and male lines containing events Ms8 and Rf3 respectively as well grains obtained from traditional crossings (Ms8xRf3 hybrid) between these female and male parental lines, which contain the following inserted DNA:

Female line (Ms8)

1.PTA29-barnase-3’nos:

—the tapetum cell-specific promoter PTA29 from Nicotiana tabacum,

—the barnase gene from Bacillus amyloliquefaciens to engineer male sterility,

—part of the 3’ non-coding region (3’ nos) of the nopaline synthase gene of Agrobacterium tumefaciens;

2.PssuAra-bar-3’g7:

—the PssuAra promoter from Arabidopsis thaliana,

—the bar gene isolated from Streptomyces hygroscopicus conferring tolerance to the herbicide glufosinate-ammonium,

—the 3’ untranslated sequence of the TL-DNA gene 7 of Agrobacterium tumefaciens;

Male line (Rf3)

3.PTA29-barstar-3’nos:

—the tapetum cell-specific promoter PTA29 from Nicotiana tabacum,

—the barstar gene from Bacillus amyloliquefaciens to engineer fertility restoration,

—part of the 3’ non-coding region (3’ nos) of the nopaline synthase gene of Agrobacterium tumefaciens;

4.PssuAra-bar-3’g7:

—the PssuAra promoter from Arabidopsis thaliana,

—the bar gene isolated from Streptomyces hygroscopicus conferring tolerance to the herbicide glufosinate-ammonium,

—the 3’ untranslated sequence of the TL-DNA gene 7 of Agrobacterium tumefaciens.

2. The consent shall cover grains from progeny derived from crosses of oilseed rape line Ms8, Rf3 and Ms8xRf3 with any traditionally bred oilseed rape as or in products.

Article 3 - Conditions for placing on the market

The products may be put to the same uses as any other oilseed rape, with the exception of cultivation and uses as or in food, and may be placed on the market subject to the following conditions:

(a)the period of validity of the consent shall be for a period of 10 years starting from the date on which the consent is issued;

(b)the unique identifiers of the products shall be:

—ACS-BNØØ5-8 for lines containing the Ms8 event alone;

—ACS-BNØØ3-6 for lines containing the Rf3 event alone, and;

—ACS-BNØØ5-8 x ACS-BNØØ3-6 for hybrid lines containing both the Ms8 and Rf3 events;

(c)without prejudice to Article 25 of Directive 2001/18/EC, the consent holder shall, whenever requested to do so, make positive and negative control samples of the products, or their genetic material, or reference materials available to the competent authorities;

(d)without prejudice to specific labelling requirements provided by Regulation (EC) No 1829/2003, the words ‘This product contains genetically modified oilseed rape’ or ‘This product contains genetically modified Ms8 oilseed rape’ or ‘This product contains genetically modified Rf3 oilseed rape’ or ‘This product contains genetically modified Ms8xRf3 oilseed rape’, as appropriate, shall appear either on a label or in a document accompanying the product, except where other Community legislation sets a threshold below which such information is not required; and

(e)as long as the products have not been authorised for the placing on the market for the purpose of cultivation, the words ‘not for cultivation’ shall appear either on a label or in a document accompanying the products.

Article 4 - Monitoring

1. Throughout the period of validity of the consent, the consent holder shall ensure that the monitoring plan, contained in the notification and consisting of a general surveillance plan, to check for any adverse effects on human and animal health or the environment arising from handling or use of the products, is put in place and implemented.

2. The consent holder shall directly inform the operators and users concerning the safety and general characteristics of the products and of the conditions as to monitoring, including the appropriate management measures to be taken in case of accidental grain spillage. Technical guidelines for the implementation of this Article are provided in the Annex to this Decision.

3. The consent holder shall submit to the Commission and to the competent authorities of the Member States annual reports on the results of the monitoring activities.

4. Without prejudice to Article 20 of Directive 2001/18/EC the monitoring plan as notified shall, where appropriate and subject to the agreement of the Commission and the competent authority of the Member State which received the original notification, be revised by the consent holder, and/or by the competent authority of the Member State which received the original notification, in the light of the results of the monitoring activities. Proposals for a revised monitoring plan shall be submitted to the competent authorities of the Member States.

5. The consent holder shall be in the position to give evidence to the Commission and the competent authorities of the Member States:

(a)that the existing monitoring networks, as specified in the monitoring plan contained in the notification, gathers the information relevant for the monitoring of the products; and

(b)that these existing monitoring networks have agreed to make available that information to the consent holder before the date of submission of the monitoring reports to the Commission and competent authorities of the Member States in accordance with paragraph 3.

Article 5 - Applicability

This Decision shall apply from the date on which detection methods specific to the Ms8 and Rf3 events and the Ms8xRf3 hybrid oilseed rape are validated by the Community Reference Laboratory as referred to in the Annex of Regulation (EC) No 1829/2003, and as specified in Commission Regulation (EC) No 641/2004 (7) on detailed rules for the implementation of Regulation (EC) No 1829/2003.

This Decision is addressed to the Kingdom of Belgium.