Genetically Modified Organisms

ACS-BNØØ7-1

Products subject to Commission Decisions on withdrawal from the market.

Event TOPAS 19/2
Addressee BASF SE
Address of addressee BASF SE

Carl-Bosch- Str. 38, 67063 Ludwigshafen, Germany
Product Market Withdrawal The products hereunder are subject to the provisions of Commission Implementing Decision (EU) 2019/1562 of 16 September 2019 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:

The presence of material which contains, consists of or is produced from ACS-BNØØ7-1 oilseed rape 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 2022, provided that this presence:
(a) is adventitious or technically unavoidable; and
(b) is in a proportion no higher than 0,1 % mass fraction.

1.) Processed oil from genetically modified canola seed, transformation event TOPAS 19/2 and all conventional crosses

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 organisms (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 24/06/1997, opinion on substantial equivalence by the UK Advisory Committee on Novel Foods and Processes, confirmation by the UK Ministry of Agriculture, Fisheries and Food on 12/05/1997.

2.) Feed consisting of and/or containing or produced from ACS-BNØØ7-1 swede rape for the placing on the market of the product or handling in the environment during import and before and during storage and processing

notified as existing feed falling within the scope of Article 20(1)(a) of Regulation (EC) No 1829/2003, which consists of and/or contains a genetically modified organism (GMO) and which has been placed on the market in accordance with Part C to the Directives 90/220/EEC, Decision to grant consent: 98/291/EC (OJ L 131, p. 26-27 - 05/05/1998).
Designation Genetically modified canola (Brassica napus L. spp. oleifera) derived from traditional breeding crosses between non-genetically modified swede rape and a line resulting from transformation event TOPAS 19/2 which has been transformed using plasmid pOCA/AC containing:

a) a synthetic pat gene coding for Phosphinothricin Acetyltransferase under the regulation of 35S promoter and terminator sequences from cauliflower mosaic virus, and

b) an npt II gene coding for Neomycin Phosphotransferase II under the regulation of the nopaline synthase promoter and on actopine synthase terminator sequence.
Method for detection - Event-specific real time quantitative PCR detection for ACS-BNØØ7-1 maize

     - Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx
Reference material Certified reference material available via the American Oil Chemists Society at https://www.aocs.org/crm
Unique identifier ACS-BNØØ7-1
Annex II to the Cartagena Protocol https://bch.cbd.int/database/record.shtml?documentid=102078
Conditions or restrictions on the placing on the market See Commission Implementing Decision (EU) 2019/1562 of 16 September 2019
Post-market monitoring requirements Not appropriate
Date of entry into the register 18/04/2005
Date of placing on the market 24/06/1997 (as food)

05/05/1998 (as feed, feed materials and feed additives)
Legal base Commission Decision 2007/307/EC of 25 April on the withdrawal from the market of Topas 19/2 (ACS-BNØØ7-1) oilseed rape and its derived products
Further information on risk assessment Scientific Committee on Plants of 10/02/1998:

http://europa.eu.int/comm/food/fs/sc/scp/out03_en.html
Version: 1.1.3