02013D0327 — EN — 02.08.2019 — 002.001

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►B ►M2 COMMISSION IMPLEMENTING DECISION 2013/327/EU of 25 June 2013 authorising the placing on the market of food and feed containing, consisting of or produced from genetically modified oilseed rapes Ms8, Rf3 and Ms8 × Rf3 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council ◄ (notified under document C(2013) 3873) (Only the German text is authentic) (Text with EEA relevance) (2013/327/EU) (OJ L 175 27.6.2013, p. 57)

Amended by:









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COMMISSION IMPLEMENTING DECISION 2013/327/EU

of 25 June 2013

authorising the placing on the market of food and feed containing, consisting of or produced from genetically modified oilseed rapes Ms8, Rf3 and Ms8 × Rf3 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

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(notified under document C(2013) 3873)

(Only the German text is authentic)

(Text with EEA relevance)

(2013/327/EU)







Article 1

Genetically modified organism 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, as provided for in Regulation (EC) No 65/2004.

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Article 2

Authorisation

The following products are authorised for the purposes of Article 4(2) and Article 16(2) of Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision:

(a) foods and food ingredients containing, consisting of or produced from ACS-BNØØ5-8, ACS-BNØØ3-6 and ACS-BNØØ5-8 × ACS-BNØØ3-6 oilseed rapes;

(b) feed containing, consisting of or produced from ACS-BNØØ5-8, ACS-BNØØ3-6 and ACS-BNØØ5-8 × ACS-BNØØ3-6 oilseed rapes;

(c) ACS-BNØØ5-8, ACS-BNØØ3-6 and ACS-BNØØ5-8 × ACS-BNØØ3-6 oilseed rapes in products containing them or consisting of them for uses other than those provided in points (a) and (b), with the exception of cultivation.

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Article 3

Labelling

For the purposes of the labelling requirements laid down in Articles 13(1) and 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’.

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The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying products containing or consisting of genetically modified oilseed rapes referred to in Article 2, with the exception of foods and food ingredients.

Article 3a

Method of 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.

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Article 4

Monitoring 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 Decision 2009/770/EC.

Article 5

Community register

The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

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Article 6

Authorisation holder

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

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Article 7

Validity

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

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Article 8

Addressee

This Decision is addressed to BASF SE, Carl-Bosch-Str. 38, D-67063 Ludwigshafen, Germany.

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ANNEX

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(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, consisting of, or produced from ACS-BNØØ5-8, ACS-BNØØ3-6 and ACS-BNØØ5-8 × ACS-BNØØ3-6 oilseed rapes;

(2) feed containing, consisting of, or produced from ACS-BNØØ5-8, ACS-BNØØ3-6 and ACS-BNØØ5-8 × ACS-BNØØ3-6 oilseed rapes;

(3) ACS-BNØØ5-8, ACS-BNØØ3-6 and ACS-BNØØ5-8 × ACS-BNØØ3-6 oilseed rapes in products containing them or consisting of them for uses other than those provided in points (1) and (2), with the exception of cultivation.

The genetically modified ACS-BNØØ5-8, ACS-BNØØ3-6 and ACS-BNØØ5-8 × ACS-BNØØ3-6 oilseed rapes, as described in the applications, express the phosphinothricin acetyl transferase (PAT) protein which confers tolerance to the herbicidal active ingredient glufosinate-ammonium and barnase (ACS-BNØØ5-8) and barstar (ACS-BNØØ3-6) proteins for male sterility and restorer of fertility.

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(c) Labelling

For the purposes of the specific labelling requirements laid down in Articles 13(1) and 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’.

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The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying products containing or consisting of genetically modified oilseed rapes referred to in point (b), with the exception of foods and food ingredients.

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(d) Method for detection

— Event specific real-time PCR based method for the quantification of ACS-BNØØ5-8, ACS-BNØØ3-6 and ACS-BNØØ5-8 × ACS-BNØØ3-6 oilseed rape;

— Validated on seeds by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm

— Reference Material: AOCS 0306-B, AOCS 0306-F and AOCS 0306-G are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm

(e) Unique identifiers

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 [to be entered 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

Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC [to be entered in the Community register of genetically modified food and feed when notified].

(i) Post market monitoring requirements for the use of the food for human consumption

Not required.