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National Node of the BCH
Country's Decision or any other Communication
Record information and status
Record ID
104799
Status
Published
Date of creation
2013-03-22 17:36 UTC (enrico.ben@ec.europa.eu/14451)
Date of publication
2013-03-26 13:43 UTC (Joachim.Kreysa@ec.europa.eu)

General information
Country submitting the decision or communication
  • European Union
Competent National Authority(ies) responsible for the decision or communication
European Commission - Health and Food Safety Directorate General SANTE
Rue Belliard, B232
Brussels
Belgium, 1040
Phone:+32 2 2962362
Fax:+32 2 2964736
Email:chantal.bruetschy@ec.europa.eu
Url:European Commission - Health and Food Safety Directorate General SANTE
Title / Reference number of the decision or communication
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
Date of the decision
2007-03-26
Is the decision taken prior to entry into force of the Protocol?
No
Jurisdiction
  • European Union
Is this an amendment to a previous decision / communication?
No
Decision or communication details
Subject(s) of the decision
Uses of the LMO(s)
  • LMOs for direct use as feed
  • LMOs for processing
Has the decision been taken in the absence of a domestic regulatory framework and in accordance with Article 11.6?
No
Importer’s or Applicant’s contact details
Bayer CropScience AG
Alfred-Nobel-Strasse 50
Monheim am Rhein
Germany, D - 40789
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Conditions
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;

(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.
Reasons
The consent shall, in accordance with Article 19(3) of Directive
2001/18/EC, explicitly specify the conditions to which the
consent is subject.
LMO identification
ACS-BNØØ3-6 - InVigor™ canola
Changes in physiology and/or production - Fertility restoration Resistance to herbicides - Glufosinate
Show detection method(s)
ACS-BNØØ5-8 - InVigor™ canola
Changes in physiology and/or production - Reproduction - Male sterility Resistance to herbicides - Glufosinate
Show detection method(s)
ACS-BNØØ5-8 x ACS-BNØØ3-6 - InVigor™ canola
Changes in physiology and/or production - Reproduction - Male sterility Resistance to herbicides - Glufosinate
Show detection method(s)
Risk assessment
Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to the application (Reference C/BE/96/01) for the placing on the market of glufosinate-tolerant hybrid oilseed rape Ms8 x Rf3, derived from genetically modified parental lines (Ms8, Rf3), for import and processing for feed and industrial uses, under Part C of Directive 2001/18/EC from Bayer CropScience
ACS-BNØØ5-8 x ACS-BNØØ3-6 - InVigor™ canola
Changes in physiology and/or production - Reproduction - Male sterility
Resistance to herbicides - Glufosinate
ACS-BNØØ5-8 - InVigor™ canola
Changes in physiology and/or production - Reproduction - Male sterility
Resistance to herbicides - Glufosinate
ACS-BNØØ3-6 - InVigor™ canola
Changes in physiology and/or production - Fertility restoration
Resistance to herbicides - Glufosinate
Additional Information
Additional Information
EU Detection Method validated by EU-RL GMFF