Commission Implementing Decision (EU) 2024/389 of 26 January 2024 renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified oilseed rape Ms8, Rf3 and Ms8 × Rf3 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2024) 432)
Genetically 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.
Authorisation
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.
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 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).
Method 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.
Monitoring 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.
Community 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.
Authorisation holder
The authorisation holder shall be BASF Agricultural Solutions Seed US LLC, United States, represented in the Union by BASF SE, Germany.
Validity
This Decision shall apply for a period of 10 years from the date of its notification.
Addressee
This Decision is addressed to BASF Agricultural Solutions Seed US LLC, 100 Park Avenue, Florham Park, New Jersey 07932, United States, represented in the Union by BASF SE, Carl-Bosch-Str. 38, 67063 Ludwigshafen, Germany.
Supplementary provisions
ANNEXSupplementary provisions
ANNEX
(a) Applicant and authorisation holder:
Name: BASF Agricultural Solutions Seed US LLC
Address: 100 Park Avenue, Florham Park, New Jersey 07932, United States of America
Represented in the Union by: BASF SE, Carl-Bosch-Str. 38, 67063 Ludwigshafen, Germany.
(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 Council ( 1 ) .
[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.
( 1 ) Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC ( OJ L 106, 17.4.2001, p. 1 ).
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.