Prováděcí rozhodnutí Komise (EU) 2019/1195 ze dne 10. července 2019, kterým se mění rozhodnutí 2008/730/ES, 2008/837/ES, 2009/184/ES, 2011/354/EU, prováděcí rozhodnutí 2012/81/EU, 2013/327/EU, (EU) 2015/690, (EU) 2015/697, (EU) 2015/699, (EU) 2016/1215, (EU) 2017/1208 a (EU) 2017/2451, pokud jde o držitele povolení a zástupce pro uvádění geneticky modifikované sóji, bavlny, řepky olejné a kukuřice na trh (oznámeno pod číslem C(2019) 5093) (Text s významem pro EHP.)

Identifier:: 32019D1195
Status:: effective
Text language:: en

THE EUROPEAN COMMISSION,

Article 6 Article 6 Authorisation holder

Article 7 Article 7 Authorisation holders

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feedOJ L 268, 18.10.2003, p. 1 . , and in particular to Article 9(2) and Article 21(2) thereof,

Decision 2008/730/EC is amended as follows:

OJ L 268, 18.10.2003, p. 1 .

(1) Bayer CropScience AG, based in Germany, is the authorisation holder for the placing on the market of genetically modified food and feed (soybean, cotton, oilseed rape and maize) under Regulation (EC) No 1829/2003, covered by Commission Decisions 2008/730/ECCommission Decision 2008/730/EC of 8 September 2008 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean A2704-12 (ACS-GMØØ5-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 247, 16.9.2008, p. 50 ). , 2008/837/ECCommission Decision 2008/837/EC of 29 October 2008 authorising the placing on the market of products containing, consisting of, or produced from genetically modified LLCotton25 (ACS-GHØØ1-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 299, 8.11.2008, p. 36 ). , 2009/184/ECCommission Decision 2009/184/EC of 10 March 2009 authorising 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 (OJ L 68, 13.3.2009, p. 28 ). , 2011/354/EUCommission Decision 2011/354/EU of 17 June 2011 authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton GHB614 (BCS-GHØØ2-5) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 160, 18.6.2011, p. 90 ). , Commission Implementing Decisions 2012/81/EUCommission Implementing Decision 2012/81/EU of 10 February 2012 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean A5547-127 (ACS-GMØØ6-4) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 40, 14.2.2012, p. 10 ). , 2013/327/EUCommission Implementing Decision 2013/327/EU of 25 June 2013 authorising the placing on the market of food containing or consisting of genetically modified oilseed rape Ms8, Rf3 and Ms8 × Rf3, or food and feed produced from those genetically modified organisms pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 175, 27.6.2013, p. 57 ). , (EU) 2015/690Commission Implementing Decision (EU) 2015/690 of 24 April 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton GHB614×LLCotton25 (BCS-GHØØ2-5×ACS-GHØØ1-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 112, 30.4.2015, p. 35 ). , (EU) 2015/697Commission Implementing Decision (EU) 2015/697 of 24 April 2015 authorising the placing on the market of genetically modified maize T25 (ACS-ZMØØ3-2) and renewing the existing maize T25 (ACS-ZMØØ3-2) products, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 112, 30.4.2015, p. 66 ). , (EU) 2015/699Commission Implementing Decision (EU) 2015/699 of 24 April 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton T304-40 (BCS-GHØØ4-7) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 112, 30.4.2015, p. 77 ). and (EU) 2016/1215Commission Implementing Decision (EU) 2016/1215 of 22 July 2016 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean FG72 (MST-FGØ72-2) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 199, 26.7.2016, p. 16 ). .

(2) Bayer CropScience N.V., based in Belgium, is the authorisation holder for the placing on the market of a genetically modified food and feed (cotton) and represents Bayer CropScience LP, based in the United States, for the authorisation under Commission Implementing Decision (EU) 2017/1208Commission Implementing Decision (EU) 2017/1208 of 4 July 2017 authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton GHB119 (BCS-GHØØ5-8) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ L 173, 6.7.2017, p. 23 ). .

(3) Bayer CropScience N.V., based in Belgium, is the authorisation holder for the placing on the market of a genetically modified food and feed (soybean) and represents M.S. Technologies LLC, based in the United States, for the authorisation under Commission Implementing Decision (EU) 2017/2451Commission Implementing Decision (EU) 2017/2451 of 21 December 2017 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean FG72 × A5547-127, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ L 346, 28.12.2017, p. 20 ). .

(4) By letter dated 1 August 2018 , Bayer CropScience AG, Germany, Bayer CropScience N.V., Belgium and Bayer CropScience LP, United States, requested, that the Commission transfers their rights and obligations pertaining to all authorisations and pending applications for genetically modified products, to BASF Agricultural Solutions Seed US LLC, based in the United States.

(5) By letter dated 19 October 2018 , BASF Agricultural Solutions Seed US LLC confirmed their consent to this transfer and authorised BASF SE, based in Germany, to act as its EU representative.

(6) On 11 October 2018 , M.S. Technologies LLC confirmed in writing its agreement with the change of their representative.

(7) Annexes to Decisions 2008/730/EC, 2008/837/EC, 2009/184/EC and 2011/354/EU contain links to the webpages of The American Oil Chemists' Society, where the reference materials for detection method are available, which are linked to Bayer, therefore, these links should be adapted accordingly.

(8) The proposed amendments to the authorisation decisions are purely administrative in nature and do not entail a new assessment of the products concerned. The same applies to the addressees of the authorisation decisions concerned, which should also be adapted accordingly.

(9) The implementation of the requested changes requires the amendment of decisions authorising the placing on the market of genetically modified products for which Bayer CropScience AG and Bayer CropScience N.V. are the authorisation holders. In particular, the following decisions should therefore be amended accordingly: Decisions 2008/730/EC, 2008/837/EC, 2009/184/EC, 2011/354/EU, Implementing Decisions 2012/81/EU, 2013/327/EU, (EU) 2015/690, (EU) 2015/697, (EU) 2015/699, (EU) 2016/1215, (EU) 2017/1208 and (EU) 2017/2451.

(10) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1) In Article 6, Bayer CropScience AG is replaced by BASF Agricultural Solutions Seed US LLC, USA, represented by BASF SE, Germany;

(2) In Article 8, Bayer CropScience AG, Alfred-Nobel-Straße 50, D-40789 Monheim am Rhein is replaced by BASF SE, Carl-Bosch-Str. 38, 67063 Ludwigshafen;

(3) Point (a) of the Annex is replaced by the following:(a) Applicant and authorisation holder: NameBASF Agricultural Solutions Seed US LLCAddress100 Park Avenue, Florham Park, New Jersey 07932, United States of AmericaRepresented by BASF SE, Carl-Bosch-Str. 38, 67063 Ludwigshafen, Germany.

(4) Point (d), third indent, of the Annex is replaced by the following:— reference material: AOCS 0707-A and AOCS 0707-B accessible via the American Oil Chemists Society at https://www.aocs.org/crm.

— reference material: AOCS 0707-A and AOCS 0707-B accessible via the American Oil Chemists Society at https://www.aocs.org/crm.

Decision 2008/837/EC is amended as follows:

Commission Decision 2008/730/EC of 8 September 2008 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean A2704-12 (ACS-GMØØ5-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 247, 16.9.2008, p. 50 ).

Article 1 Article 1 Amendment to Decision 2008/730/EC

Article 2 Article 2 Amendment to Decision 2008/837/EC

Article 3 Article 3 Amendment to Decision 2009/184/EC

Article 4 Article 4 Amendment to Decision 2011/354/EU

Article 5 Article 5 Amendment to Implementing Decision 2012/81/EU

Article 6 Article 6 Amendment to Implementing Decision 2013/327/EU

Article 7 Article 7 Amendment to Implementing Decision (EU) 2015/690

Article 8 Article 8 Amendment to Implementing Decision (EU) 2015/697

Article 9 Article 9 Amendment to Implementing Decision (EU) 2015/699

(1) In Article 6, Bayer CropScience AG is replaced by BASF Agricultural Solutions Seed US LLC, USA, represented by BASF SE, Germany;

Article 10 Article 10 Amendment to Implementing Decision (EU) 2016/1215

Article 13 Article 13 Addressee

(2) In Article 8, Bayer CropScience AG, Alfred-Nobel-Strasse 50, D-40789 Monheim am Rhein is replaced by BASF SE, Carl-Bosch-Str. 38, 67063 Ludwigshafen;

(4) Point (d), third indent, of the Annex is replaced by the following:— reference material: AOCS 0306-A and AOCS 0306-E accessible via the American Oil Chemists Society at https://www.aocs.org/crm.

— reference material: AOCS 0306-A and AOCS 0306-E accessible via the American Oil Chemists Society at https://www.aocs.org/crm.

Decision 2009/184/EC is amended as follows:

Commission Decision 2008/837/EC of 29 October 2008 authorising the placing on the market of products containing, consisting of, or produced from genetically modified LLCotton25 (ACS-GHØØ1-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 299, 8.11.2008, p. 36 ).

(1) In Article 7, Bayer CropScience AG is replaced by BASF Agricultural Solutions Seed US LLC, USA, represented by BASF SE, Germany;

(2) In Article 9, Bayer CropScience AG, Alfred-Nobel-Straße 50, 40789 Monheim am Rhein is replaced by BASF SE, Carl-Bosch-Str. 38, 67063 Ludwigshafen;

(4) Point (d), third indent, of the Annex is replaced by the following:— reference material: AOCS 0208-A accessible via the American Oil Chemists Society at https://www.aocs.org/crm.

— reference material: AOCS 0208-A accessible via the American Oil Chemists Society at https://www.aocs.org/crm.

Decision 2011/354/EU is amended as follows:

Commission Decision 2009/184/EC of 10 March 2009 authorising 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 (OJ L 68, 13.3.2009, p. 28 ).

(1) In Article 6, Bayer CropScience AG is replaced by BASF Agricultural Solutions Seed US LLC, USA, represented by BASF SE, Germany;

(2) In Article 8, Bayer CropScience AG, Alfred-Nobel-Straße 50, 40789 Monheim am Rhein is replaced by BASF SE, Carl-Bosch-Str. 38, 67063 Ludwigshafen;

(4) Point (d), third indent, of the Annex is replaced by the following:— reference material: AOCS 1108-A and 0306-A is accessible via the American Oil Chemists Society at https://www.aocs.org/crm.

— reference material: AOCS 1108-A and 0306-A is accessible via the American Oil Chemists Society at https://www.aocs.org/crm.

Implementing Decision 2012/81/EU is amended as follows:

Commission Decision 2011/354/EU of 17 June 2011 authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton GHB614 (BCS-GHØØ2-5) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 160, 18.6.2011, p. 90 ).

(1) In Article 6, Bayer CropScience AG is replaced by BASF Agricultural Solutions Seed US LLC, USA, represented by BASF SE, Germany;

(2) In Article 8, Bayer CropScience AG, Alfred-Nobel-Strasse 50, 40789 Monheim am Rhein is replaced by BASF SE, Carl-Bosch-Str. 38, 67063 Ludwigshafen;

Implementing Decision 2013/327/EU is amended as follows:

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

Commission Implementing Decision 2012/81/EU of 10 February 2012 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean A5547-127 (ACS-GMØØ6-4) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 40, 14.2.2012, p. 10 ).

(1) In Article 6, Bayer CropScience AG is replaced by BASF Agricultural Solutions Seed US LLC, USA, represented by BASF SE, Germany;

(2) In Article 8, Bayer CropScience AG, Alfred-Nobel-Strasse 50, 40789 Monheim am Rhein is replaced by BASF SE, Carl-Bosch-Str. 38, 67063 Ludwigshafen;

Implementing Decision (EU) 2015/690 is amended as follows:

The authorisation holders shall be

(a) BASF Agricultural Solutions Seed US LLC, United States, represented by BASF SE, Germany;and

(b) BASF SE, Germany, representing M.S. Technologies, LLC, United States.;

Commission Implementing Decision 2013/327/EU of 25 June 2013 authorising the placing on the market of food containing or consisting of genetically modified oilseed rape Ms8, Rf3 and Ms8 × Rf3, or food and feed produced from those genetically modified organisms pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 175, 27.6.2013, p. 57 ).

(1) In Article 6, Bayer CropScience AG is replaced by BASF Agricultural Solutions Seed US LLC, USA, represented by BASF SE, Germany;

(2) In Article 8, Bayer CropScience AG, Alfred-Nobel-Strasse 50, D-40789 Monheim am Rhein is replaced by BASF SE, Carl-Bosch-Str. 38, 67063 Ludwigshafen;

Implementing Decision (EU) 2015/697 is amended as follows:

Commission Implementing Decision (EU) 2015/690 of 24 April 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton GHB614×LLCotton25 (BCS-GHØØ2-5×ACS-GHØØ1-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 112, 30.4.2015, p. 35 ).

(1) In Article 6, Bayer CropScience AG is replaced by BASF Agricultural Solutions Seed US LLC, USA, represented by BASF SE, Germany;

(2) In Article 8, Bayer CropScience AG, Alfred-Nobel-Strasse 50, D-40789 Monheim am Rhein is replaced by BASF SE, Carl-Bosch-Str. 38, 67063 Ludwigshafen;

Implementing Decision (EU) 2015/699 is amended as follows:

Commission Implementing Decision (EU) 2015/697 of 24 April 2015 authorising the placing on the market of genetically modified maize T25 (ACS-ZMØØ3-2) and renewing the existing maize T25 (ACS-ZMØØ3-2) products, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 112, 30.4.2015, p. 66 ).

(1) In Article 6, Bayer CropScience AG is replaced by BASF Agricultural Solutions Seed US LLC, USA, represented by BASF SE, Germany;

(2) In Article 8, Bayer CropScience AG, Alfred-Nobel-Strasse 50, D-40789 Monheim am Rhein is replaced by BASF SE, Carl-Bosch-Str. 38, 67063 Ludwigshafen;

Implementing Decision (EU) 2016/1215 is amended as follows:

Commission Implementing Decision (EU) 2015/699 of 24 April 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton T304-40 (BCS-GHØØ4-7) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 112, 30.4.2015, p. 77 ).

(1) In Article 6, Bayer CropScience AG is replaced by BASF Agricultural Solutions Seed US LLC, USA, represented by BASF SE, Germany;

(2) In Article 8, Bayer CropScience AG, Alfred-Nobel-Strasse 50, D-40789 Monheim am Rhein is replaced by BASF SE, Carl-Bosch-Str. 38, 67063 Ludwigshafen;

Commission Implementing Decision (EU) 2016/1215 of 22 July 2016 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean FG72 (MST-FGØ72-2) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 199, 26.7.2016, p. 16 ).

Commission Implementing Decision (EU) 2017/1208 of 4 July 2017 authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton GHB119 (BCS-GHØØ5-8) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ L 173, 6.7.2017, p. 23 ).

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

Commission Implementing Decision (EU) 2017/2451 of 21 December 2017 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean FG72 × A5547-127, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ L 346, 28.12.2017, p. 20 ).

HAS ADOPTED THIS DECISION: