Commission Implementing Decision (EU) 2019/2081 of 28 November 2019 renewing the authorisation for the placing on the market of products containing or produced from genetically modified oilseed rape T45 (ACS-BNØØ8-2), resulting from the commercialisation of this oilseed rape in third countries until 2005, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2019) 7480) (Only the German text is authentic) (Text with EEA relevance)

Implementing Decision (EU) 2019/2081 · Decision · 11 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Genetically modified organism and unique identifier

Article 1

Genetically modified oilseed rape ( Brassica napus L ) T45, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier ACS-BNØØ8-2, in accordance with Regulation (EC) No 65/2004.

Renewal of the authorisation

Article 2

1. The purpose of this Decision is to renew an authorisation covering, for the products referred to in paragraph 2, the presence of ACS-BNØØ8-2 oilseed rape resulting directly or indirectly from the commercialisation, until 2005, of ACS-BNØØ8-2 oilseed rape seeds in third countries. 2. The authorisation for the placing on the market of the following products is renewed in accordance with the conditions set out in this Decision: (a) foods and food ingredients containing or produced from genetically modified oilseed rape ACS-BNØØ8-2; (b) feed containing or produced from genetically modified oilseed rape ACS-BNØØ8-2; (c) products containing genetically modified oilseed rape ACS-BNØØ8-2 for uses other than those provided for in points (a) and (b), with the exception of cultivation.

Maximum level

Article 3

The presence of genetically modified oilseed rape ACS-BNØØ8-2 in products defined in Article 2 is authorised in a proportion not exceeding 0,9 %.

Method for detection

Article 4

The method set out in point (c) of the Annex shall apply for the detection of genetically modified oilseed rape ACS-BNØØ8-2.

Monitoring plan for environmental effects

Article 5

1. The authorisation holder shall ensure that the monitoring plan for environmental effects, as set out in point (g) 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.

Monitoring of the phasing out

Article 6

1. The authorisation holder shall ensure that shipments of oilseed rape imported into the Union from a third country in which genetically modified oilseed rape seeds ACS-BNØØ8-2 were commercialised until 2005 are sampled and tested appropriately for the presence of genetically modified oilseed rape ACS-BNØØ8-2. 2. The method used for the sampling of oilseed rape ACS-BNØØ8-2 shall be internationally recognised. The testing shall be made in an accredited laboratory and in accordance with the validated method of detection as set out in the Annex. 3. The authorisation holder shall submit to the Commission, together with the reports referred to in Article 5(2), annual reports on the monitoring activities for the presence of genetically modified oilseed rape ACS-BNØØ8-2.

Community register

Article 7

The information set out in the Annex to this Decision 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

Article 8

The authorisation holder shall be BASF Agricultural Solutions Seed US LLC, United States, represented in the Union by BASF SE, Germany.

Validity

Article 9

This Decision shall apply for a period of 10 years from the date of its notification.

Addressee

Article 10

This Decision is addressed to 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 by BASF SE, Carl-Bosch-Str. 38, D-67063 Ludwigshafen, Germany. (b) Designation and specification of the products: (1) foods and food ingredients containing or produced from genetically modified oilseed rape ACS-BNØØ8-2; (2) feed containing or produced from genetically modified oilseed rape ACS-BNØØ8-2; (3) products containing genetically modified oilseed rape ACS-BNØØ8-2 for uses other than those provided in points (1) and (2), with the exception of cultivation. The genetically modified oilseed rape ACS-BNØØ8-2 expresses the pat gene which confers tolerance to glufosinate-ammonium based herbicides. (c) Method for detection: (1) Event specific real-time PCR based method for the detection of genetically modified oilseed rape ACS-BNØØ8-2. (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 0208-A accessible via the American Oil Chemists Society at https://www.aocs.org/crm (d) Unique identifier: ACS-BNØØ8-2 (e) 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 ]. (f) Conditions or restrictions on the placing on the market, use or handling of the products: Not required. (g) 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 ] (h) Post-market monitoring requirements for the use of the food for human consumption: 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 ).

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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