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National Node of the BCH
Country's Decision or any other Communication
Record information and status
Record ID
110602
Status
Published
Date of creation
2016-06-14 18:23 UTC (Joachim.Kreysa@ec.europa.eu)
Date of publication
2016-06-14 18:23 UTC (Joachim.Kreysa@ec.europa.eu)

This document is also available in the following languages:
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
EN
COMMISSION IMPLEMENTING DECISION (2012/69/EU) of 3 February 2012 amending Decisions 2007/305/EC, 2007/306/EC and 2007/307/EC as regards the tolerance period for traces of Ms1xRf1 (ACS-BNØØ4-7xACS-BNØØ1-4) hybrid oilseed rape, Ms1xRf2 (ACS- BNØØ4-7xACS-BNØØ2-5) hybrid oilseed rape and Topas 19/2 (ACS-BNØØ7-1) oilseed rape, as well as of their derived products
Date of the decision
2012-02-03
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?
Yes
BCH decision amended
Commission Decision 2007/305/EC on the withdrawal from the market of Ms1xRf1 (ACS-BNØØ4-7xACS-BNØØ1-4) hybrid oilseed rape and its derived products
ACS-BNØØ4-7 x ACS-BNØØ1-4 - InVigor™ canola
Changes in physiology and/or production - Reproduction - Male sterility
Resistance to antibiotics - Kanamycin
Resistance to herbicides - Glufosinate
ACS-BNØØ4-7 - InVigor™ canola
Changes in physiology and/or production - Reproduction - Male sterility
Resistance to antibiotics - Kanamycin
Resistance to herbicides - Glufosinate
ACS-BNØØ1-4 - InVigor™ canola
Changes in physiology and/or production - Fertility restoration
Resistance to antibiotics - Kanamycin
Resistance to herbicides - Glufosinate
Commission Decision 2007/306/EC on the withdrawal from the market of Ms1xRf2 (ACS-BNØØ4-7xACS-BNØØ2-5) hybrid oilseed rape and its derived products
ACS-BNØØ4-7 x ACS-BNØØ2-5 - InVigor™ canola
Changes in physiology and/or production - Reproduction - Male sterility
Resistance to antibiotics - Kanamycin
Resistance to herbicides - Glufosinate
ACS-BNØØ4-7 - InVigor™ canola
Changes in physiology and/or production - Reproduction - Male sterility
Resistance to antibiotics - Kanamycin
Resistance to herbicides - Glufosinate
ACS-BNØØ2-5 - InVigor™ canola
Changes in physiology and/or production - Fertility restoration
Resistance to antibiotics - Kanamycin
Resistance to herbicides - Glufosinate
EU Commission Decision 2007/307/EC on the withdrawal from the market of Topas 19/2 (ACS-BNØØ7-1) oilseed rape
ACS-BNØØ7-1 - Liberty-Link™ Innovator Canola
Resistance to antibiotics - Kanamycin
Resistance to herbicides - Glufosinate
Reasons for the amendment
EN
The presence of remaining minutes traces (< 0.1%) of the GM material in the food or feed chain after the expiry date set out in these decisions, despite the measures undertaken by the notifier, compels for an extension of the current transitional period for another 5 years. However the level of presence tolerated is reduced to 0.1%
Decision or communication details
Subject(s) of the decision
Uses of the LMO(s)
  • LMOs for direct use as food
  • 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
EN
The presence of material which contains, consists or is produced from ACS-BN004-7, ACS-BN001-4, ACS-BN002-5, ACS-BN004-7xACS-BN001-4, ACS-BN004-7xACS-BN002-5 and ACS-BN007-1 in food and feed products shall be tolerated until 31 December 2016 a) provided that this presence is adventitious or technically unavoidable and b) is in a proportion not higher than 0,1%.
Reasons
EN
The presence of remaining minutes traces (< 0.1%) of the GM material in the food or feed chain after the expiry date set out in the Decisions, despite the measures undertaken by the notifier, compels for further extension of the transitional period
LMO identification
ACS-BNØØ4-7 x ACS-BNØØ1-4 - InVigor™ canola
Changes in physiology and/or production - Reproduction - Male sterility Resistance to antibiotics - Kanamycin Resistance to herbicides - Glufosinate
Show detection method(s)
ACS-BNØØ4-7 x ACS-BNØØ2-5 - InVigor™ canola
Changes in physiology and/or production - Reproduction - Male sterility Resistance to antibiotics - Kanamycin Resistance to herbicides - Glufosinate
Show detection method(s)
ACS-BNØØ7-1 - Liberty-Link™ Innovator Canola
Resistance to antibiotics - Kanamycin Resistance to herbicides - Glufosinate
Show detection method(s)
ACS-BNØØ4-7 - InVigor™ canola
Changes in physiology and/or production - Reproduction - Male sterility Resistance to antibiotics - Kanamycin Resistance to herbicides - Glufosinate
Show detection method(s)
ACS-BNØØ2-5 - InVigor™ canola
Changes in physiology and/or production - Fertility restoration Resistance to antibiotics - Kanamycin Resistance to herbicides - Glufosinate
Show detection method(s)
ACS-BNØØ1-4 - InVigor™ canola
Changes in physiology and/or production - Fertility restoration Resistance to antibiotics - Kanamycin Resistance to herbicides - Glufosinate
Show detection method(s)
Risk assessment
European Food Safety Authority (EFSA) Opinion on the safeguard clause related to genetically modified crops (BT176 maize, MON810 maize, T25 maize, Topas 19/2 oilseed rape and Ms1xRf1oilseed rape)
ACS-BNØØ4-7 x ACS-BNØØ1-4 - InVigor™ canola
Changes in physiology and/or production - Reproduction - Male sterility
Resistance to antibiotics - Kanamycin
Resistance to herbicides - Glufosinate
SYN-EV176-9 - NaturGard KnockOut™ maize
Resistance to antibiotics - Ampicillin
Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths)
Resistance to herbicides - Glufosinate
MON-ØØ81Ø-6 - YieldGard™ maize
Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths)
ACS-BNØØ7-1 - Liberty-Link™ Innovator Canola
Resistance to antibiotics - Kanamycin
Resistance to herbicides - Glufosinate
ACS-ZMØØ3-2 - Liberty Link™ maize
Resistance to antibiotics - Ampicillin
Resistance to herbicides - Glufosinate
European Food Safety Authority (EFSA) Opinion on the safeguard clause related to genetically modified oilseed rape Topas 19/2
ACS-BNØØ7-1 - Liberty-Link™ Innovator Canola
Resistance to antibiotics - Kanamycin
Resistance to herbicides - Glufosinate
Decision document
Additional Information
Additional Information
EN
Detection methods for the single events oilseed rape Ms1, Rf1, Rf2 and Topas19/2 and methods for the stacks Ms1xRf1 and Ms1xRf2 verified by the European Union Laboratory for Genetically Modified Food and Feed (EURL GMFF) are available at http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx