Contents
Article 1Genetically modified organisms and unique identifiers#
Genetically modified oilseed rape (Brassica napus L.) Ms8, Rf3 and Ms8 × Rf3, as specified in point (b) of the Annex to this Decision, are assigned the unique identifiers ACS-BNØØ5-8, ACS-BNØØ3-6 and ACS-BNØØ5-8 × ACS-BNØØ3-6, respectively, in accordance with Regulation (EC) No 65/2004.
Article 2Authorisation#
The authorisation for placing on the market of the following products is renewed as regards:
(a)foods and food ingredients containing, consisting of or produced from genetically modified oilseed rapes ACS-BNØØ5-8, ACS-BNØØ3-6 and ACS-BNØØ5-8 × ACS-BNØØ3-6;
(b)feed containing, consisting of or produced from genetically modified oilseed rapes ACS-BNØØ5-8, ACS-BNØØ3-6 and ACS-BNØØ5-8 × ACS-BNØØ3-6;
(c)products containing or consisting of genetically modified oilseed rapes ACS-BNØØ5-8, ACS-BNØØ3-6 and ACS-BNØØ5-8 × ACS-BNØØ3-6, for uses other than those provided for in points (a) and (b), with the exception of cultivation.
Article 3Labelling#
1.For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003, the name of the organism shall be ‘oilseed rape’.
2.The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying the products containing or consisting of genetically modified oilseed rapes as referred to in Article 1, with the exception of products referred to in Article 2, point (a).
Article 4Method for detection#
The method set out in point (d) of the Annex shall apply for the detection of oilseed rapes ACS-BNØØ5-8, ACS-BNØØ3-6 and ACS-BNØØ5-8 × ACS-BNØØ3-6.
Article 5Monitoring plan for environmental effects#
1.The authorisation holder shall ensure that the monitoring plan for environmental effects, as set out in point (h) of the Annex, is put in place and implemented.
2.The authorisation holder shall submit to the Commission annual reports on the implementation and the results of the activities set out in the monitoring plan in accordance with the format set out in Decision 2009/770/EC.
Article 6Community register#
The information set out in the Annex shall be entered in the Community register of genetically modified food and feed, as referred to in Article 28(1) of Regulation (EC) No 1829/2003.
Article 7Authorisation holder#
The authorisation holder shall be BASF Agricultural Solutions US LLC, United States, represented in the Union by BASF Agricultural Solutions Belgium NV, Belgium.
Article 8Validity#
This Decision shall apply for a period of 10 years from the date of its notification.
Article 9Addressee#
This Decision is addressed to BASF Agricultural Solutions US LLC, 2 T.W. Alexander Dr., Durham, NC 27713, United States, represented in the Union by BASF Agricultural Solutions Belgium NV, Technologiepark-Zwijnaarde 101, 9052 Ghent, Belgium.
(a) Applicant and authorisation holder:
Name: BASF Agricultural Solutions US LLC
Address: 2 T.W. Alexander Dr., Durham, NC 27713, United States,
represented in the Union by: BASF Agricultural Solutions Belgium NV, Technologiepark-Zwijnaarde 101, 9052 Ghent, Belgium.
(b) Designation and specification of the products:
(1)foods and food ingredients containing, consisting of or produced from genetically modified oilseed rapes ACS-BNØØ5-8, ACS-BNØØ3-6 and ACS-BNØØ5-8 × ACS-BNØØ3-6;
(2)feed containing, consisting of or produced from genetically modified oilseed rapes ACS-BNØØ5-8, ACS-BNØØ3-6 and ACS-BNØØ5-8 × ACS-BNØØ3-6;
(3)products containing or consisting of genetically modified oilseed rapes ACS-BNØØ5-8, ACS-BNØØ3-6 and ACS-BNØØ5-8 × ACS-BNØØ3-6 for uses other than those provided for in points (1) and (2), with the exception of cultivation.
Genetically modified oilseed rapes ACS-BNØØ5-8, ACS-BNØØ3-6 and ACS-BNØØ5-8 × ACS-BNØØ3-6 express the phosphinothricin acetyl transferase (pat) gene, which confers tolerance to glufosinate-ammonium-based herbicides and the barnase gene (ACS-BNØØ5-8) for male sterility and the barstar gene (ACS-BNØØ3-6) restoring fertility.
(c) Labelling:
(1)For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the name of the organism shall be ‘oilseed rape’.
(2)The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of oilseed rapes ACS-BNØØ5-8, ACS-BNØØ3-6 and ACS-BNØØ5-8 × ACS-BNØØ3-6, with the exception of products referred to in point (b)(1).
(d) Method for detection:
(1)Event specific real-time quantitative PCR based method for detection of the genetically modified oilseed rapes ACS-BNØØ5-8, ACS-BNØØ3-6 and ACS-BNØØ5-8 × ACS-BNØØ3-6;
(2)Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx;
(3)Reference Material: AOCS 0306-F, AOCS 0306-G and AOCS 0306-B (for the non-genetically modified counterpart) are accessible via the American Oil Chemists Society at https://www.aocs.org/crm?SSO=True.
(e) Unique identifier:
ACS-BNØØ5-8, ACS-BNØØ3-6 and ACS-BNØØ5-8 × ACS-BNØØ3-6.
(f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity:
[Biosafety Clearing-House, Record ID number: published in the Community register of genetically modified food and feed when notified].
(g) Conditions or restrictions on the placing on the market, use or handling of the products:
Not required.
(h) Monitoring plan for environmental effects:
Monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC of the European Parliament and of the Councilnote.
[Link: plan published in the Community register of genetically modified food and feed].
(i) Post-market monitoring plan:
Not required.
Note:links to relevant documents may need to be modified over time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.
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