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Document 02015D0685-20210216
Commission Implementing Decision (EU) 2015/685 of 24 April 2015 authorising the placing on the market of genetically modified cotton MON 15985 (MON-15985-7) and renewing the authorisation for existing genetically modified cotton MON 15985 (MON-15985-7) products pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2015) 2755) (Only the Dutch and French texts are authentic) (Text with EEA relevance)Text with EEA relevance
Consolidated text: Commission Implementing Decision (EU) 2015/685 of 24 April 2015 authorising the placing on the market of genetically modified cotton MON 15985 (MON-15985-7) and renewing the authorisation for existing genetically modified cotton MON 15985 (MON-15985-7) products pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2015) 2755) (Only the Dutch and French texts are authentic) (Text with EEA relevance)Text with EEA relevance
Commission Implementing Decision (EU) 2015/685 of 24 April 2015 authorising the placing on the market of genetically modified cotton MON 15985 (MON-15985-7) and renewing the authorisation for existing genetically modified cotton MON 15985 (MON-15985-7) products pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2015) 2755) (Only the Dutch and French texts are authentic) (Text with EEA relevance)Text with EEA relevance
02015D0685 — EN — 16.02.2021 — 002.001
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COMMISSION IMPLEMENTING DECISION (EU) 2015/685 of 24 April 2015 authorising the placing on the market of genetically modified cotton MON 15985 (MON-15985-7) and renewing the authorisation for existing genetically modified cotton MON 15985 (MON-15985-7) products pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2015) 2755) (Only the Dutch and French texts are authentic) (OJ L 112 30.4.2015, p. 11) |
Amended by:
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Official Journal |
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No |
page |
date |
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COMMISSION IMPLEMENTING DECISION (EU) 2019/1579 of 18 September 2019 |
L 244 |
8 |
24.9.2019 |
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COMMISSION IMPLEMENTING DECISION (EU) 2021/184 of 12 February 2021 |
L 55 |
4 |
16.2.2021 |
COMMISSION IMPLEMENTING DECISION (EU) 2015/685
of 24 April 2015
authorising the placing on the market of genetically modified cotton MON 15985 (MON-15985-7) and renewing the authorisation for existing genetically modified cotton MON 15985 (MON-15985-7) products pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council
(notified under document C(2015) 2755)
(Only the Dutch and French texts are authentic)
(Text with EEA relevance)
Article 1
Genetically modified organism and unique identifier
Genetically modified cotton (Gossypium hirsutum L. and Gossypium barbadense L.) MON 15985, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-15985-7, as provided for in Regulation (EC) No 65/2004.
Article 2
Authorisation
The following products are authorised for the purposes of Articles 4(2) and 16(2) of Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision:
foods and food ingredients containing, consisting of, or produced from MON-15985-7 cotton;
feed containing, consisting of, or produced from MON-15985-7 cotton;
MON-15985-7 cotton in products containing it or consisting of it for any other use than those provided in points (a) and (b), with the exception of cultivation.
Article 3
Labelling
Article 4
Monitoring for environmental effects
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.
Article 6
Authorisation holder
The authorisation holder shall be Bayer Agriculture BV, Belgium, representing Bayer CropScience LP, United States.
Article 7
Validity
This Decision shall apply for a period of 10 years from the date of its notification.
Article 8
Addressee
This Decision is addressed to Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium.
ANNEX
(a) Applicant and authorisation holder
Name |
: |
Bayer Agriculture BV |
Address |
: |
Scheldelaan 460, 2040 Antwerp, Belgium |
On behalf of Bayer CropScience LP, 800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States.
(b) Designation and specification of the products
Foods and food ingredients containing, consisting of, or produced from MON-15985-7 cotton.
Feed containing, consisting of, or produced from MON-15985-7 cotton.
MON-15985-7 cotton in products containing it or consisting of it for any other use than those provided in points 1 and 2, with the exception of cultivation.
The genetically modified MON-15985-7 cotton, as described in the application, expresses the Cry2Ab2 and Cry1Ac proteins which confer protection against certain lepidopteran pests and GUS protein which acts as selection marker. In addition, an nptII gene, conferring kanamycin and neomycin resistance, and aadA gene, conferring spectinomycin and streptomycin resistance, were used as selective markers in the genetic modification process.
(c) 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 ‘cotton’.
The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying products containing or consisting of MON-15985-7 cotton with the exception of products referred to in point (a) of Article 2.
(d) Method for detection
Event specific real-time PCR based method for the quantification of MON-15985-7.
Validated on genomic DNA, extracted from seeds 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: AOCS 0804-D and AOCS 0804-A are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm
(e) Unique identifier
MON-15985-7
(f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity
Biosafety Clearing-House, Record ID: see [to be completed 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 conforming with Annex VII to Directive 2001/18/EC.
[Link: plan published on the internet]
(i) 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 the time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.