| Event |
MS8, RF3, MS8xRF3 |
| Authorisation holder Name |
Bayer CropScience GmbH |
| Authorisation holder Address |
Bayer CropScience GmbH
Industriepark Höchst, K607
D-65926 Frankfurt am Main - GERMANY |
| Products |
1.) Foods produced from MS8, RF3, MS8xRF3 oilseed rape (processed oil)
processed oil notified as existing food falling within the scope of Article 8(1)(a) of Regulation (EC) No 1829/2003, which is produced from a genetically modified organism (GMO) and which has been placed on the market in accordance with Art. 5 of Regulation (EC) No 258/97, notification forwarded to Member States on 8/11/1999, opinion on substantial equivalence by the German Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinarmedizin (bgvv) on 30/09/1999.
2.) Feed containing or consisting of MS8, RF3, MS8xRF3 oilseed rape
Commission Decision of 26 March 2007 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of oilseed rape products (Brassica napus L., lines Ms8, Rf3 and Ms8xRf3) genetically modified for tolerance to the herbicide glufosinate-ammonium.
3.) Feed produced from MS8, RF3, MS8xRF3 oilseed rape
notified as existing feed falling within the scope of Article 20(1)(b) of Regulation (EC) No 1829/2003, namely as feed materials which are produced from a genetically modified organism (GMO).
4.) Other products containing or consisting of MS8, RF3, MS8xRF3 oilseed rape with the exception of cultivation
Commission Decision of 26 March 2007 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of oilseed rape products (Brassica napus L., lines Ms8, Rf3 and Ms8xRf3) genetically modified for tolerance to the herbicide glufosinate-ammonium. |
| Designation |
1.) The male sterile oilseed rape line MS8 and progeny obtained through traditional breeding crosses with non-transgenic rape (Brassica napus L spp oleifera). Line MS8 contains a barnase gene (origin Bacillus amyloliquefaciens) coding for a ribonuclease, that is only expressed in the tapetum cells during anther development and results in lack of viable pollen and male sterility, and a bar gene (origin Streptomyces hygroscopus) coding for a phosphinothricin acetyl transferase (PAT) used as a selectable marker for tolerance to herbicides containing glufosinate ammonium. The bar gene is driven by a plant promoter that is active in all green tissues of the plant.
2.) The fertility restoration line oilseed rape RF3 and progeny obtained through traditional breeding crosses with non-transgenic rape (Brassica napus L spp oleifera). Line RF3 contains a barstar gene (origin Bacillus amyloliquefaciens), coding for an inhibitor of the Barnase protein, that is only expressed in the tapetum cells and lead to restoration of fertility after crossing to the male sterile line, and a bar gene (origin Streptomyces hygroscopus) coding for PAT used as a selectable marker for tolerance to herbicides containing glufosinate ammonium. The bar gene is driven by a plant promoter that is active in all green tissues of the plant.
3.) The hybrid seed MS8xRF3 derived from traditional crossings between the parental lines MS8 and RF3. |
| Labelling |
Article 13(1) and 25(1) of Regulation (EC) No 1829/2003 |
| Method for detection |
A real-time quantitative PCR detection method for MS8, RF3, MS8xRF3 oilseed rape
This detection method is under validation by the Joint Research Centre (JRC) of the European Commission, URL: http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm |
| Reference material |
Molecular & Biochemical Analytical Services
Bayer BioScience N.V.
Technologiepark 38
B- 9052 Gent, Belgium |
| Unique identifier |
ACS-BNØØ5-8
ACS-BNØØ3-6
ACS-BNØØ5-8 x ACS-BN003-6 |
| Annex II to the Cartagena Protocol |
Biosafety Clearing House, Record ID 1232, URL:
http://bch.biodiv.org/database/record.aspx?searchid=142832&recordid=1232 |
| Conditions or restrictions on the placing on the market |
Not applicable |
| Post-market monitoring requirements |
Not appropriate |
| Date of authorisation |
25/05/2007: feed containing or consisting of MS8, RF3, MS8xRF3 oilseed rape; other products containing or consisting of MS8, RF3, MS8xRF3 oilseed rape with the exception of cultivation.
Application for renewal submitted: foods produced from MS8, RF3, MS8xRF3 oilseed rape (processed oil); feed produced from MS8, RF3, MS8xRF3 oilseed rape. |
| Legal base |
Art. 8(1)(a) and 20(1)(b) of the Regulation (EC) No 1829/2003
Article 19(3) of Directive 2001/18/EC |
| Authorisation expiration date |
24/05/2017: feed containing or consisting of MS8, RF3, MS8xRF3 oilseed rape; other products containing or consisting of MS8, RF3, MS8xRF3 oilseed rape with the exception of cultivation.
Procedure for renewal ongoing: foods produced from MS8, RF3, MS8xRF3 oilseed rape (processed oil); feed produced from MS8, RF3, MS8xRF3 oilseed rape. |
| Further information on risk assessment |
Scientific Committee on Plants, URL: http://europa.eu.int/comm/food/fs/sc/scp/out09_en.html |
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