European Union | BCH-DEC-EU-111610 | Country's Decision or any other Communication | Biosafety Clearing-House

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Country's Decision or any other Communication (DEC)

last updated: 10 Feb 2017
Amendment
Yes
  • BCH-DEC-EUR-102075-2 Country's Decision or any other Communication 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 | Canola plant | ACS-BNØØ4-7 - InVigor™ canola | Rapeseed, Canola plant, Canola | ACS-BNØØ1-4 - InVigor™ canola | Rapeseed, Canola plant, Canola
  • BCH-DEC-EUR-102076-2 Country's Decision or any other Communication 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 | Canola plant | ACS-BNØØ4-7 - InVigor™ canola | Rapeseed, Canola plant, Canola | ACS-BNØØ2-5 - InVigor™ canola | Rapeseed, Canola plant, Canola
  • BCH-DEC-EUR-102078-1 Country's Decision or any other Communication 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 | Rapeseed, Canola plant, Canola
  • BCH-DEC-EUR-110602-1 Country's Decision or any other Communication 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
    ACS-BNØØ4-7 x ACS-BNØØ1-4 - InVigor™ canola | Canola plant | ACS-BNØØ4-7 x ACS-BNØØ2-5 - InVigor™ canola | Canola plant | ACS-BNØØ7-1 - Liberty-Link™ Innovator Canola | Rapeseed, Canola plant, Canola | ACS-BNØØ4-7 - InVigor™ canola | Rapeseed, Canola plant, Canola | ACS-BNØØ2-5 - InVigor™ canola | Rapeseed, Canola plant, Canola | ACS-BNØØ1-4 - InVigor™ canola | Rapeseed, Canola plant, Canola
All three Decisions provided for a transitional period of time of 5 years, during which food and feed containing the GM material were allowed to be placed on the market, in accordance with Article 4(2) or Article 16(2) of Regulation (EC) 1829/2003, subject to a number of conditions. The Decisions required in particular that the presence of the GM material in food and feed does not exceed a threshold of 0,9% and that the presence of this GM material be adventitious or technically unavoidable. This transition period was extended until 31 December 2016 with a tolerance threshold of 0,1% by Decision (EU) 2012/69.

Recent test results reported by the authorisation-holder on oilseed rape shipments from Canada intended for the EU showed that the measures undertaken by the authorisation-holder have allowed the removal of nearly all the GM material from the market. Yet the results showed that minute traces (< 0,1%) of the GM material could still be detected in the food or feed chain at the end of the transitional period set out in Decision (EU) 2012/69.

Therefore, Decision (EU) 2016/2268 amending Decisions 2007/305/EC, 2007/306/EC and 2007/307/EC as regards the tolerance period for traces of Ms1×Rf1 (ACS-BNØØ4-7×ACS-BNØØ1-4) hybrid oilseed rape, Ms1×Rf2 (ACS- BNØØ4-7×ACS-BNØØ2-5) hybrid oilseed rape and Topas 19/2 (ACS-BNØØ7-1) oilseed rape, as well as their derived products, sets out a supplementary transitional period until 31 December 2019 which should provide sufficient time to allow the total removal of the GM material from the food and feed chain.
EN
General information
COMMISSION IMPLEMENTING DECISION (EU) 2016/2268 of 14 December 2016 amending Decisions 2007/305/EC, 2007/306/EC and 2007/307/EC as regards the tolerance period for traces of Ms1×Rf1 (ACS-BNØØ4-7×ACS-BNØØ1-4) hybrid oilseed rape, Ms1×Rf2 (ACS- BNØØ4-7×ACS-BNØØ2-5) hybrid oilseed rape and Topas 19/2 (ACS-BNØØ7-1) oilseed rape, as well as their derived products
EN
14 Dec 2016
No
Subject of the decision, notification, communication or declaration
  • Decision on LMOs for direct use as food or feed, or for processing (Article 11, LMOs-FFP)
LMOs for direct use as food or feed, or for processing (LMOs-FFP)
  • LMOs for direct use as food
  • LMOs for direct use as feed
  • LMOs for processing
No
Result of the decision
Approval of the import and/or use of the LMO(s) with conditions
1) The addressee shall implement an in-house program in order to ensure the effective withdrawal from the market of the oilseed rape events ACS-BNØØ4-7, ACS-BNØØ1-4, ACS-BNØØ2-5, ACS- BNØØ7-1 and the hybrid combinations ACS-BNØØ4-7×ACS-BNØØ1-4 and ACS-BNØØ4-7×ACS-BNØØ2-5 in breeding and seed production and shall gather data on the presence of those genetically modified organisms in the oilseed rape shipments to the Union from Canada.

The addressee shall report to the Commission on the implementation of this program and on the presence of those genetically modified organisms in the oilseed rape shipments to the Union from Canada by 1 January 2019.


2) The presence of material which contains, consists of or is produced from these oilseed rape events in food or feed products notified under point (a) of Article 8(1) and Article 20(1) of Regulation (EC) No 1829/2003 shall be tolerated until 31 December 2019, provided that this presence:
(a) is adventitious or tecto enable control laboratories to perform their analysis during this transitional periodhnically unavoidable; and
(b) is in a proportion no higher than 0,1 % mass fraction.


3) The addressee shall ensure the continued availability of certified reference material for these oilseed rape events via the American Oil Chemists Society at https://www.aocs.org/attain-lab-services/certified-reference- materials-(crms) to enable control laboratories to perform their analysis during this transitional period.
EN
The presence of remaining minute traces (<0.1%) of GM material in the food and feed chain after the expiry date set out in the Decision (EU) 2012/69, despite the measures taken by the notifier, compels further extension of the transition period and the establishment of a set of measures to assure the  effective withdrawal from the market of these oilseed rape events and the monitoring of the implementation program.
EN
LMO identification & risk assessment
  • BCH-LMO-SCBD-14757-7 Living Modified Organism 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
  • BCH-LMO-SCBD-14758-7 Living Modified Organism 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
  • BCH-LMO-SCBD-14761-7 Living Modified Organism ACS-BNØØ7-1 - Liberty-Link™ Innovator Canola
    Resistance to antibiotics - Kanamycin Resistance to herbicides - Glufosinate
  • BCH-LMO-SCBD-14756-5 Living Modified Organism ACS-BNØØ4-7 - InVigor™ canola
    Changes in physiology and/or production - Reproduction - Male sterility Resistance to antibiotics - Kanamycin Resistance to herbicides - Glufosinate
  • BCH-LMO-SCBD-14754-5 Living Modified Organism ACS-BNØØ2-5 - InVigor™ canola
    Changes in physiology and/or production - Fertility restoration Resistance to antibiotics - Kanamycin Resistance to herbicides - Glufosinate
  • BCH-LMO-SCBD-14753-6 Living Modified Organism ACS-BNØØ1-4 - InVigor™ canola
    Changes in physiology and/or production - Fertility restoration Resistance to antibiotics - Kanamycin Resistance to herbicides - Glufosinate
  • BCH-RA-EUR-102074-4 Risk Assessment generated by a regulatory process 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 | Resistance to herbicides, Resistance to antibiotics, Changes in physiology and/or production | SYN-EV176-9 - NaturGard KnockOut™ maize | Resistance to diseases and pests, Resistance to herbicides, Resistance to antibiotics | MON-ØØ81Ø-6 - YieldGard™ maize | Resistance to diseases and pests | ACS-BNØØ7-1 - Liberty-Link™ Innovator Canola | Resistance to herbicides, Resistance to antibiotics | ACS-ZMØØ3-2 - Liberty Link™ maize | Resistance to herbicides, Resistance to antibiotics
  • BCH-RA-EUR-102077-3 Risk Assessment generated by a regulatory process 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 herbicides, Resistance to antibiotics
Document on the decision, communication, notification or declaration
Additional Information
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
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