30.4.2015   

EN

Official Journal of the European Union

L 112/1

(1)

On 29 May 2009, Monsanto Europe SA submitted to the competent authority of The Netherlands an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from MON 87460 maize (‘the application’).

(2)

The application also covers the placing on the market of MON 87460 maize in products consisting of it or containing it for any other uses than food and feed as any other maize, with the exception of cultivation.

(3)

In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council (2) and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

(4)

On 15 November 2012, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that MON 87460 maize, as described in the application, is as safe as its conventional counterpart and non-GM reference varieties with respect to potential effects on human and animal health and the environment, in the context of its intended use. EFSA performed a specific risk assessment linked to the presence of the antibiotic resistance marker nptII gene in MON 87460. The detailed analysis of risks associated with a theoretically possible horizontal gene transfer did not raise safety concerns to human or animal health or to the environment in the context of MON 87460 intended uses. In its opinion, EFSA also considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Article 6(4) and Article 18(4) of that Regulation.

(5)

In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.

(6)

Taking into account those considerations, authorisation should be granted for the products containing, consisting, or produced from MON 87460 maize, as described in the application, called (‘the products’).

(7)

A unique identifier should be assigned to each genetically modified organism (hereinafter ‘GMO’) as provided for in Commission Regulation (EC) No 65/2004 (3).

(8)

On the basis of the EFSA opinion, no specific labelling requirements other than those provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from MON 87460 maize. However, in order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of products containing or consisting of the GMO with the exception of food products for which authorisation is requested should be complemented by a clear indication that the products in question must not be used for cultivation.

(9)

Regulation (EC) No 1830/2003 of the European Parliament and of the Council (4), lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.

(10)

The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC (5). The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Article 6(5) and Article 18(5) of Regulation (EC) No 1829/2003.

(11)

All relevant information on the authorisation of the products should be entered in the EU register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.

(12)

This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and Article 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (6).

(13)

The applicant has been consulted on the measures provided for in this Decision.

(14)

The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

(a)

foods and food ingredients containing, consisting of, or produced from MON 8746Ø-4 maize;

(b)

feed containing, consisting of, or produced from MON 8746Ø-4 maize;

(c)

MON 8746Ø-4 maize in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.

30.4.2015   

EN

Official Journal of the European Union

L 112/6

(1)

By Commission Decision 2004/643/EC (2), the placing on the market of feed containing or consisting of NK603 maize and NK603 maize in products consisting of it or containing it for any other uses than food and feed, with the exception of cultivation, is authorised in accordance with Directive 2001/18/EC of the European Parliament and of the Council (3), until 17 October 2014.

(2)

By Commission Decision 2005/448/EC (4), the placing on the market of foods and food ingredients containing, consisting of or produced from NK603 maize is authorised in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council (5), until 2 March 2015.

(3)

Food and feed additives and feed materials produced from genetically modified maize NK603 were placed on the market before the entry into force of Regulation (EC) No 1829/2003 and were notified as existing products in accordance with Articles 8(1)(b) and 20(1)(b) of that Regulation when it came into force.

(4)

On 2 August 2005, Monsanto Europe S.A. submitted to the European Commission an application, in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003, for the renewal of food and feed additives and feed materials produced from NK603 maize which were previously notified as existing products in accordance with Articles 8(1)(b) and 20(1)(b) of that Regulation.

(5)

On 2 August 2005, Monsanto Europe S.A. submitted to the competent authority of the Netherlands an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from NK603 maize.

(6)

This application also covered the placing on the market of NK603 maize in products consisting of it or containing it for any other uses than food and feed as any other maize, including the seeds for cultivation.

(7)

In accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

(8)

On 25 March 2008, the Spanish Competent Authority and its Biosafety Commission provided to the European Food Safety Authority (‘EFSA’) its opinion on the environmental risk assessment in line with Articles 6(3)(c) and 18(3)(c) of Regulation (EC) No 1829/2003 and it concluded that according to the current state of scientific knowledge and after examining the existing information and data provided by the applicant, the Spanish Commission on Biosafety could give a favourable opinion to the commercialisation in the EU of maize NK603 if the proposals and conditions established in the Environmental Risk Assessment report are implemented.

(9)

On 11 June 2009, EFSA gave a favourable opinion for both applications in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that NK603 maize, as described in the application, is as safe as its conventional counterpart with respect to potential effects on human and animal health and the environment (6). In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of that Regulation.

(10)

In its opinion, EFSA also concluded that the environmental monitoring plan submitted by the applicant is in line with the intended uses of the products.

(11)

On 14 March 2014, Monsanto Europe S.A. informed the European Commission of its decision to amend the scope of the abovementioned new application to no longer include authorisation for cultivation of NK603 maize in the European Union.

(12)

Taking into account those considerations, authorisation should be granted for the products, with the exception of cultivation, and the environmental monitoring plan should be adapted to the modified scope.

(13)

A unique identifier should be assigned to each genetically modified organism (hereinafter ‘GMO’) as provided for in Commission Regulation (EC) No 65/2004 (7).

(14)

On the basis of the EFSA opinion, no specific labelling requirements other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from NK603 maize. However, in order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of products containing or consisting of the GMO with the exception of food products for which authorisation is requested should be complemented by a clear indication that the products in question must not be used for cultivation.

(15)

Regulation (EC) No 1830/2003 of the European Parliament and of the Council (8), lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.

(16)

The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC (9). The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Article 6(5) and Article 18(5) of Regulation (EC) No 1829/2003.

(17)

All relevant information on the authorisation of the products should be entered in the EU register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.

(18)

This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and Article 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (10).

(19)

Commission Decisions 2004/643/EC and 2005/448/EC should be repealed.

(20)

The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

(a)

foods and food ingredients containing, consisting of, or produced from MON-ØØ6Ø3-6 maize;

(b)

feed containing, consisting of, or produced from MON-ØØ6Ø3-6 maize;

(c)

MON-ØØ6Ø3-6 maize in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.

30.4.2015   

EN

Official Journal of the European Union

L 112/11

(1)

On 9 December 2004, Monsanto Europe S.A. submitted to the competent authority of the United Kingdom an application in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 for the placing on the market of food and feed produced from genetically modified cotton MON 15985.

(2)

Food additives, feed materials and feed additives produced from genetically modified cotton MON 15985 were placed on the market before the entry into force of Regulation (EC) No 1829/2003 and were notified as existing products in accordance with Articles 8(1)(b) and 20(1)(b) of that Regulation.

(3)

On 17 April 2007, Monsanto Europe S.A. submitted to the Commission an application in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003 for the renewal of the authorisation for existing food additives, feed materials and feed additives produced from genetically modified cotton MON 15985.

(4)

On 22 April 2008, Monsanto Europe S.A. submitted a new broader application for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from genetically modified cotton MON 15985, including the existing products (‘the application’) and on 2 July 2008 withdrew its application submitted on 9 December 2004.

(5)

The application also covers the placing on the market of genetically modified cotton MON 15985 in products consisting of it or containing it for other uses than food and feed as any other cotton, with the exception of cultivation.

(6)

In accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003 the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council (2) and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to that Directive. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

(7)

On 29 July 2014, the European Food Safety Authority (‘EFSA’) gave an opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 (3). It concluded that genetically modified cotton MON 15985, as described in the application, is as safe as its conventional counterpart and non-genetically modified cotton commercial varieties and is unlikely to have adverse effects on human and animal health and the environment, notwithstanding the incompleteness in the agronomic and phenotypic dataset. Considering the scope of these applications and the poor ability of cotton to survive outside cultivated fields, EFSA concluded that the likelihood of any adverse environmental impacts due to the accidental release into the environment of viable seeds from cotton MON 15985 is very low.

(8)

EFSA concluded that the analysis of horizontal gene transfer from genetically modified cotton MON 15985 to bacteria did not indicate a risk to human or animal health or to the environment in the context of its intended uses, considering the expected low frequency of gene transfer from plant to bacteria compared with that between bacteria, and the very low exposure to DNA from genetically modified cotton MON 15985.

(9)

EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.

(10)

EFSA also concluded that the monitoring plan for environmental effects, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.

(11)

Consequently, authorisation should be granted to the products containing, consisting of, or produced from genetically modified cotton MON 15985.

(12)

A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004 (4).

(13)

On the basis of the EFSA opinion, no specific labelling requirements, other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from genetically modified cotton MON 15985. However, in order to ensure the use of those products within the limits of the authorisation granted by this Decision, the labelling of the products containing, consisting of, or produced from MON 15985 cotton, with the exception of food products, should be complemented by a clear indication that the products in question are not intended for cultivation.

(14)

Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council (5) lays down labelling requirements for products containing or consisting of GMOs. Traceability requirements for those products are laid down in paragraphs 1 to 5 of Article 4 and traceability requirements for food and feed produced from GMOs are laid down in Article 5 of that Regulation.

(15)

The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC (6). The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Articles 6(5)(e) and 18(5)(e) of Regulation (EC) No 1829/2003.

(16)

All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.

(17)

This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Articles 9(1) and 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (7).

(18)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

(a)

foods and food ingredients containing, consisting of, or produced from MON-15985-7 cotton;

(b)

feed containing, consisting of, or produced from MON-15985-7 cotton;

(c)

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.

30.4.2015   

EN

Official Journal of the European Union

L 112/16

(1)

On 14 September 2009, Monsanto Europe SA submitted to the competent authority of the United Kingdom an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from MON 87769 soybean (‘the application’).

(2)

The application also covers the placing on the market of MON 87769 soybean in products consisting of it or containing it for any other uses than food and feed as any other soybean, with the exception of cultivation.

(3)

In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council (2) and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

(4)

On 16 May 2014, the European Food Safety Authority (‘EFSA’) gave a favourable opinion (3) in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that MON 87769 soybean, as described in the application, is as safe as its conventional counterpart and is unlikely to have adverse effects on human and animal health and the environment in the context of the scope of the application.

(5)

In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.

(6)

In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.

(7)

In addition, EFSA recommended a post-market monitoring plan to be implemented, focusing on the collection of consumption data for the European population.

(8)

Taking into account those considerations, authorisation should be granted to the products.

(9)

A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004 (4).

(10)

Food, food ingredients and feed containing, consisting of, or produced from soybean MON 87769 should be labelled in accordance with the requirements provided for in Article 13(1) and Article 25(2)(a) and (b) of Regulation (EC) No 1829/2003.

(11)

On the basis of the EFSA opinion, confirming that fatty acid composition of the seeds of MON 87769 soybean and derived oil has been changed in relation to the conventional counterpart, specific labelling appears to be necessary in accordance with Articles 13(2)(a) and 25(2)(c). This specific labelling should ensure informed choice without misleading the consumers.

(12)

In order to ensure the use of the products containing or consisting of MON 87769 soybean within the limits of the authorisation provided for by this Decision, the labelling of these products, with the exception of food products, should be complemented by a clear indication that the products in question must not be used for cultivation.

(13)

Regulation (EC) No 1830/2003 of the European Parliament and of the Council (5) lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.

(14)

The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC (6). The EFSA opinion does not justify the imposition of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Article 6(5)(e) and Article 18(5)(e) of Regulation (EC) No 1829/2003.

(15)

The authorisation holder should also submit annual reports on the implementation and the results of the activities set out in the post-market monitoring plan.

(16)

All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.

(17)

This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and Article 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (7).

(18)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

(a)

foods and food ingredients containing, consisting of, or produced from MON-87769-7 soybean;

(b)

feed containing, consisting of, or produced from MON-87769-7 soybean;

(c)

MON-87769-7 soybean in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.

30.4.2015   

EN

Official Journal of the European Union

L 112/22

(1)

On 31 August 2011, Monsanto Europe S.A. submitted to the competent authority of Belgium an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from MON 88302 oilseed rape (‘the application’).

(2)

The application also covers the placing on the market of MON 88302 oilseed rape in products consisting of it or containing it for any other uses than food and feed as any other oilseed rape, with the exception of cultivation.

(3)

In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council (2) and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

(4)

On 17 June 2014, the European Food Safety Authority (‘EFSA’) gave a favourable opinion (3) in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that MON 88302 oilseed rape is as safe as its conventional counterpart and non-GM oilseed rape commercial varieties and is unlikely to have adverse effects on human and animal health and the environment in the context of the scope of the application.

(5)

In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.

(6)

In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.

(7)

Taking into account those considerations, authorisation should be granted to the products.

(8)

A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004 (4).

(9)

On the basis of the EFSA opinion, no specific labelling requirements other than those provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from MON 88302 oilseed rape. However, in order to ensure the use of the products containing or consisting of MON 88302 oilseed rape within the limits of the authorisation provided for by this Decision, the labelling of these products, with the exception of food products, should be complemented by a clear indication that the products in question must not be used for cultivation.

(10)

Regulation (EC) No 1830/2003 of the European Parliament and of the Council (5) lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.

(11)

The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC (6). The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or of specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Article 6(5)(e) and Article 18(5)(e) of Regulation (EC) No 1829/2003.

(12)

All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.

(13)

This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and Article 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (7).

(14)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time-limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

(a)

foods and food ingredients containing, consisting of, or produced from MON-883Ø2-9 oilseed rape;

(b)

feed containing, consisting of, or produced from MON-883Ø2-9 oilseed rape;

(c)

MON-883Ø2-9 oilseed rape in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.

30.4.2015   

EN

Official Journal of the European Union

L 112/26

(1)

On 28 February 2007, Monsanto Europe S.A. submitted to the competent authority of the United Kingdom an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from MON 88913 cotton (‘the application’).

(2)

The application also covers the placing on the market of MON 88913 cotton in products consisting of it or containing it for other uses than food and feed as any other cotton, with the exception of cultivation.

(3)

In accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council (2) and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

(4)

On 29 July 2013, the European Food Safety Authority (‘EFSA’) gave an opinion (3) in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It could not reach an overall conclusion on the MON 88913 cotton due to the use by the applicant of an outdated toxin database for the bioinformatic analyses.

(5)

On 18 October 2013, the applicant provided new bioinformatic analyses using updated databases.

(6)

On 13 March 2014, EFSA published a statement complementing its scientific opinion (4), taking into account those updated bioinformatic analyses, and concluded that MON 88913 cotton assessed in the initial scientific opinion and in the supplementary bioinformatic dataset is as safe and nutritious as its conventional counterpart and commercial cotton varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses.

(7)

In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.

(8)

In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.

(9)

Taking into account those considerations, authorisation should be granted to the products.

(10)

A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004 (5).

(11)

On the basis of the EFSA opinion, no specific labelling requirements other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003 appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from MON 88913 cotton. However, in order to ensure the use of the products containing or consisting of MON 88913 cotton within the limits of the authorisation provided for by this Decision, the labelling of these products, with the exception of food products, should be complemented by a clear indication that the products in question must not be used for cultivation.

(12)

Regulation (EC) No 1830/2003 of the European Parliament and of the Council (6) lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.

(13)

The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC (7). The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or of specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Articles 6(5)(e) and 18(5)(e) of Regulation (EC) No 1829/2003.

(14)

All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.

(15)

This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and Article 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (8).

(16)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

(a)

foods and food ingredients containing, consisting of, or produced from MON-88913-8 cotton;

(b)

feed containing, consisting of, or produced from MON-88913-8 cotton;

(c)

MON-88913-8 cotton in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.

30.4.2015   

EN

Official Journal of the European Union

L 112/31

(1)

Food additives, feed materials and feed additives produced from genetically modified cotton MON 531 were placed on the market before the entry into force of Regulation (EC) No 1829/2003 and were notified as existing products in accordance with Articles 8(1)(b) and 20(1)(b) of that Regulation.

(2)

On 17 April 2007, Monsanto Europe S.A. submitted to the Commission an application in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003 for the renewal of the authorisation for existing food additives, feed materials and feed additives produced from genetically modified cotton MON 531 (‘the application’).

(3)

On 16 June 2011, Monsanto Europe S.A. requested an extension of the scope of the application to include food cottonseed oil produced from genetically modified cotton MON 531, which was previously notified as an existing product in accordance with Article 8(1)(a) of Regulation (EC) No 1829/2003.

(4)

The scope of the application as extended covers the full range of current commercial uses of food and feed produced from cotton as defined in Articles 3(1)(c) and 15(1)(c) of Regulation (EC) No 1829/2003.

(5)

On 16 September 2011, the European Food Safety Authority (‘EFSA’) gave a favourable opinion (2) in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that products derived from genetically modified cotton MON 531, as described in the application, are as safe as products derived from its conventional counterpart, in the context of their intended uses.

(6)

EFSA concluded that the analysis of horizontal gene transfer from genetically modified cotton MON 531 to bacteria did not indicate a risk to human or animal health or to the environment in the context of its intended uses, considering the expected low frequency of gene transfer from plant to bacteria compared with that between bacteria, and the very low exposure to DNA from genetically modified cotton MON 531.

(7)

EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.

(8)

Consequently, authorisation should be renewed for the products produced from genetically modified cotton MON 531.

(9)

A unique identifier should be assigned to each genetically modified organism as provided for in Commission Regulation (EC) No 65/2004 (3).

(10)

On the basis of the EFSA opinion, no specific labelling requirements, other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed produced from genetically modified cotton MON 531.

(11)

All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.

(12)

This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and Article 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (4).

(13)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

(a)

food produced from MON-ØØ531-6 cotton;

(b)

feed produced from MON-ØØ531-6 cotton.

30.4.2015   

EN

Official Journal of the European Union

L 112/35

(1)

On 1 February 2010, Bayer CropScience AG submitted to the competent authority of The Netherlands an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from GHB614xLLCotton25 cotton (‘the application’).

(2)

The application also covers the placing on the market of GHB614xLLCotton25 cotton in products consisting of it or containing it for any other uses than food and feed as any other cotton, with the exception of cultivation.

(3)

In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council (2) and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

(4)

On 16 May 2014, the European Food Safety Authority (‘EFSA’) gave a favourable opinion (3) in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that GHB614xLLCotton25 cotton, as described in the application, is as safe as its conventional counterpart and commercial cotton varieties and that it is unlikely to have any adverse effects on human and animal health or the environment, in the context of its intended uses.

(5)

In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.

(6)

In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.

(7)

Taking into account those considerations, authorisation should be granted to the products.

(8)

A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004 (4).

(9)

On the basis of the EFSA opinion, no specific labelling requirements other than those provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from GHB614xLLCotton25 cotton. However, in order to ensure the use of the products containing or consisting of GHB614xLLCotton25 cotton within the limits of the authorisation provided for by this Decision, the labelling of these products, with the exception of food products, should be complemented by a clear indication that the products in question must not be used for cultivation.

(10)

Regulation (EC) No 1830/2003 of the European Parliament and of the Council (5) lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.

(11)

The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC (6). The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or of specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Article 6(5)(e) and Article 18(5)(e) of Regulation (EC) No 1829/2003.

(12)

All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.

(13)

This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and Article 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (7).

(14)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time-limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

(a)

foods and food ingredients containing, consisting of, or produced from BCS-GHØØ2-5xACS-GHØØ1-3 cotton;

(b)

feed containing, consisting of, or produced from BCS-GHØØ2-5xACS-GHØØ1-3 cotton;

(c)

BCS-GHØØ2-5xACS-GHØØ1-3 cotton in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.

30.4.2015   

EN

Official Journal of the European Union

L 112/40

(1)

On 5 January 2009, BASF Plant Science GmbH submitted to the competent authority of The Netherlands an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from BPS-CV127-9 soybean (‘the application’).

(2)

The application also covers the placing on the market of soybean BPS-CV127-9 in products consisting of it or containing it for any other uses than food and feed as any other soybean, with the exception of cultivation.

(3)

In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council (2) and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

(4)

On 17 January 2014, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that BPS-CV127-9 soybean, as described in the application, is as safe as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses (3). However, the EFSA GMO Panel could not conclude on the use of forage as or in feed as data on compositional analysis of forage were not in line with the EFSA requirements and no new data on forage were provided by the applicant.

(5)

Since forage is usually used where the cultivation takes place and no import is therefore expected in the EU, forage could be excluded from the scope of this authorisation.

(6)

In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.

(7)

In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.

(8)

Taking into account those considerations, authorisation should be granted to the products, with the exception of forage as or in feed.

(9)

A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004 (4).

(10)

On the basis of the EFSA opinion, no specific labelling requirements other than those provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from BPS-CV127-9 soybean. However, in order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of products containing or consisting of the GMO for which authorisation is requested, with the exception of food products, should be complemented by a clear indication that the products in question must not be used for cultivation.

(11)

Regulation (EC) No 1830/2003 of the European Parliament and of the Council (5) lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.

(12)

The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC (6). The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Article 6(5) and Article 18(5) of Regulation (EC) No 1829/2003.

(13)

All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.

(14)

This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and point (c) of Article 15(2) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (7).

(15)

The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

(a)

foods and food ingredients containing, consisting of, or produced from BPS-CV127-9 soybean;

(b)

feed containing, consisting of, or produced from BPS-CV127-9 soybean with the exception of forage;

(c)

BPS-CV127-9 soybean, in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.

30.4.2015   

EN

Official Journal of the European Union

L 112/44

(1)

Pursuant to Directive 2001/18/EC, the placing on the market of a product containing or consisting of a genetically modified organism or a combination of genetically modified organisms is subject to written consent being granted by the competent authority of the Member State that received the notification for the placing on the market of that product, in accordance with the procedure laid down in that Directive.

(2)

A notification concerning the placing on the market of a genetically modified carnation (Dianthus caryophyllus L., line 25958) was submitted by Florigene Ltd, Melbourne, Australia, to the competent authority of the Netherlands in March 2009.

(3)

The notification covers import, distribution and retailing of cut flowers of carnation Dianthus caryophyllus L., line 25958 as for any other carnation.

(4)

In accordance with the procedure established by Article 14 of Directive 2001/18/EC, the competent authority of the Netherlands prepared an assessment report, which concluded that no reasons have emerged on the basis of which consent for the placing on the market of cut flowers of the genetically modified carnation (Dianthus caryophyllus L., line 25958) for ornamental use should be withheld, if specific conditions are fulfilled.

(5)

In its assessment report, the competent authority of the Netherlands also concluded that the general surveillance plan submitted by the applicant is sufficient taking into account the intended uses of the product.

(6)

The assessment report was submitted to the Commission and the competent authorities of the other Member States, some of which raised and maintained objections to the placing on the market of the product.

(7)

The opinion of the European Food Safety Authority (EFSA), published on 12 December 2014, concluded, from all evidence provided, that there is no scientific reason to consider that the placing on the market of the genetically modified carnation (Dianthus caryophyllus L., line 25958) for ornamental use will cause any adverse effects on human health or the environment (2). EFSA also found that the scope of the monitoring plan provided by the notifier is in line with the intended use of the carnation.

(8)

An examination of the full notification, additional information provided by the notifier, specific objections maintained by the Member States in the light of Directive 2001/18/EC, and the opinion of EFSA, discloses no reason to believe that the placing on the market of cut flowers of the genetically modified carnation (Dianthus caryophyllus L., line 25958) will adversely affect human health or the environment in the context of its proposed ornamental use.

(9)

A unique identifier has been assigned to the genetically modified carnation (Dianthus caryophyllus L., line 25958) for the purposes of Regulation (EC) No 1830/2003 of the European Parliament and of the Council (3) and Commission Regulation (EC) No 65/2004 (4).

(10)

In light of the opinion of the European Food Safety Authority, it is not necessary to establish specific conditions for the intended use with regard to the handling or packaging of the product and the protection of particular ecosystems, environments or geographical areas.

(11)

The proposed labelling, on a label or in an accompanying document, should include wording to inform operators and final users that the cut flowers of Dianthus caryophyllus L., line 25958 cannot be used for human or animal consumption nor for cultivation.

(12)

A detection method as required by Annex III B.D.12 of Directive 2001/18/EC, was verified and tested for the Dianthus caryophyllus L., line 25958 by the European Union Reference Laboratory in December 2012.

(13)

The Committee set up under Article 30(1) of Directive 2001/18/EC has not delivered an opinion within the time-limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

(a)

Cassette 1

The petunia dfr gene encoding dihydroflavonol 4-reductase (DFR), a key enzyme in the anthocyanin biosynthetic pathway, including its own promoter and terminator.

(b)

Cassette 2

The promoter sequence from snapdragon chalcone synthase gene, flavonoid 3′5′-hydroxylase (f3′5′h) from Viola hortensis cDNA encoding F3′5′H, a key enzyme in the anthocyanin biosynthetic pathway, and the terminator from a petunia gene encoding a phospholipid transfer protein homologue.

(c)

Cassette 3

The Cauliflower mosaic virus 35S promoter, a hairpin-forming construct consisting of a partial dihydroflavonol 4-reductase dfr sense and antisense fragment separated by a petunia dfr intron, targeted to specific, post-transcriptional down-regulation of endogenous carnation dfr, and the CaMV 35S terminator sequence.

These three cassettes were inserted into the plant genome to obtain the desired flower colour.

(d)

Cassette 4

The Cauliflower mosaic virus 35S promoter, the 5′untranslated region of the petunia gene coding for chlorophyll a/b binding protein, the SuRB (als) gene coding for a mutant acetolactate synthase protein (ALS) derived from Nicotiana tabacum which confers tolerance to sulfonylurea, including its own terminator. This trait was used as a marker in the selection of transformants.

(a)

In accordance with Article 19(3)(b) of Directive 2001/18/EC, the period of validity of the consent shall be 10 years starting from the date on which the consent is issued;

(b)

The unique identifier of the product shall be IFD-25958-3;

(c)

Without prejudice to Article 25 of Directive 2001/18/EC, the methodology for detecting and identifying the product, including experimental data demonstrating the specificity of the methodology as single-laboratory validated by the EU Reference Laboratory is publicly available at http://gmo-crl.jrc.ec.europa.eu/valid-2001-18.htm;

(d)

Without prejudice to Article 25 of Directive 2001/18/EC, the consent holder shall, whenever requested to do so, make positive and negative control samples of the product, or its genetic material, or reference materials available to the competent authorities and to inspection services of Member States as well as to EU control laboratories;

(e)

The words ‘This product is a genetically modified organism’ or ‘This product is a genetically modified carnation’, and the words ‘not for human or animal consumption nor for cultivation’ shall appear either on a label or in a document accompanying the product.

(a)

that the existing monitoring networks, including national botanic survey networks and plant protection services, as specified in the monitoring plan contained in the notification, gather the information relevant for the monitoring of the products; and

(b)

that these existing monitoring networks referred to in point (a) have agreed to make available that information to the consent holder before the date of submission of the monitoring reports to the Commission and competent authorities of the Member States in accordance with paragraph 3.

30.4.2015   

EN

Official Journal of the European Union

L 112/48

(1)

Food additives, feed materials and feed additives produced from genetically modified cotton MON 1445 were placed on the market before the entry into force of Regulation (EC) No 1829/2003 and were notified as existing products in accordance with Articles 8(1)(b) and 20(1)(b) of that Regulation.

(2)

On 17 April 2007, Monsanto Europe SA submitted to the Commission an application in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003 for the renewal of the authorisation for existing food additives, feed materials and feed additives produced from genetically modified cotton MON 1445 (‘the application’).

(3)

On 16 June 2011, Monsanto Europe SA requested an extension of the scope of the application to include food cottonseed oil produced from genetically modified cotton MON 1445, which was previously notified as an existing product in accordance with Article 8(1)(a) of Regulation (EC) No 1829/2003.

(4)

The scope of the application as extended covers the full range of current commercial uses of food and feed produced from cotton as defined in Articles 3(1)(c) and 15(1)(c) of Regulation (EC) No 1829/2003.

(5)

On 16 December 2011, the European Food Safety Authority (‘EFSA’) gave a favourable opinion (2) in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that products derived from genetically modified cotton MON 1445, as described in the application, are as safe as products derived from its conventional counterpart, in the context of their intended uses.

(6)

EFSA concluded that the analysis of horizontal gene transfer from genetically modified cotton MON 1445 to bacteria did not indicate a risk to human or animal health or to the environment in the context of its intended uses, considering the expected low frequency of gene transfer from plant to bacteria compared with that between bacteria, and the very low exposure to DNA from genetically modified cotton MON 1445.

(7)

EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.

(8)

Consequently, authorisation should be renewed for the products produced from genetically modified cotton MON 1445.

(9)

A unique identifier should be assigned to each genetically modified organism as provided for in Commission Regulation (EC) No 65/2004 (3).

(10)

On the basis of the EFSA opinion, no specific labelling requirements, other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed produced from genetically modified cotton MON 1445.

(11)

All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.

(12)

This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Articles 9(1) and 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (4).

(13)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

(a)

food produced from MON-Ø1445-2 cotton;

(b)

feed produced from MON-Ø1445-2 cotton.

30.4.2015   

EN

Official Journal of the European Union

L 112/52

(1)

Pursuant to Directive 2001/18/EC, the placing on the market of a product containing or consisting of a genetically modified organism or a combination of genetically modified organisms is subject to written consent being granted by the competent authority of the Member State that received the notification for the placing on the market of that product, in accordance with the procedure laid down in that Directive.

(2)

A notification concerning the placing on the market of a genetically modified carnation (Dianthus caryophyllus L., line 26407) was submitted by Florigene Ltd, Melbourne, Australia, to the competent authority of the Netherlands in March 2009.

(3)

The notification covers import, distribution and retailing of cut flowers of Dianthus caryophyllus L., line 26407 as for any other carnation.

(4)

In accordance with the procedure established by Article 14 of Directive 2001/18/EC, the competent authority of the Netherlands prepared an assessment report, which concluded that no reasons have emerged on the basis of which consent for the placing on the market of cut flowers of the genetically modified carnation (Dianthus caryophyllus L., line 26407) for ornamental use should be withheld, if specific conditions are fulfilled.

(5)

In its assessment report, the competent authority of the Netherlands also concluded that the general surveillance plan submitted by the applicant is sufficient taking into account the intended uses of the product.

(6)

The assessment report was submitted to the Commission and the competent authorities of the other Member States, some of which raised and maintained objections to the placing on the market of the product.

(7)

The opinion of the European Food Safety Authority (EFSA), published on 12 December 2014, concluded that, from all evidence provided, there is no scientific reason to consider that the placing on the market of the genetically modified carnation (Dianthus caryophyllus L., line 26407) for ornamental use will cause any adverse effects on human health or the environment (2). EFSA also found that the scope of the monitoring plan provided by the notifier is in line with the intended use of the carnation.

(8)

An examination of the full notification, additional information provided by the notifier, specific objections maintained by the Member States in the light of Directive 2001/18/EC, and the opinion of EFSA, discloses no reason to believe that the placing on the market of cut flowers of the genetically modified carnation (Dianthus caryophyllus L., line 26407) will adversely affect human health or the environment in the context of its proposed ornamental use.

(9)

A unique identifier has been assigned to the genetically modified carnation (Dianthus caryophyllus L., line 26407) for the purposes of Regulation (EC) No 1830/2003 of the European Parliament and of the Council (3) and Commission Regulation (EC) No 65/2004 of 14 January 2004 (4).

(10)

In light of the opinion of the European Food Safety Authority, it is not necessary to establish specific conditions for the intended use with regard to the handling or packaging of the product and the protection of particular ecosystems, environments or geographical areas.

(11)

The proposed labelling, on a label or in an accompanying document, should include wording to inform operators and final users that the cut flowers of Dianthus caryophyllus L., line 26407 cannot be used for human or animal consumption, nor for cultivation.

(12)

A detection method as required by Annex III B.D.12 of Directive 2001/18/EC, was verified and tested for the Dianthus caryophyllus L., line 26407 by the European Union Reference Laboratory in November 2013.

(13)

The Committee set up under Article 30(1) of Directive 2001/18/EC has not delivered an opinion within the time-limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

(a)

Cassette 1

The promoter from snapdragon chalcone synthase gene, the petunia cytochrome b5 (difF) cDNA encoding a cytochrome b5 protein to enhance activity of F3′5′H, and the terminator from a petunia gene encoding a phospholipid transfer protein homologue.

(b)

Cassette 2

The petunia flavonoid 3′5′-hydroxylase cDNA (f3′5′h) encoding F3′5′H, a key enzyme in the anthocyanin biosynthetic pathway and the promoter and terminator of a Dianthus caryophyllus anthocyanidin synthase (ans) gene.

These two cassettes were inserted into the plant genome to obtain the desired flower colour.

(c)

Cassette 3

The Cauliflower mosaic virus 35S promoter, the 5'untranslated region of the petunia gene coding for chlorophyll a/b binding protein, the SuRB (als) gene coding for a mutant acetolactate synthase protein (ALS) derived from Nicotiana tabacum, which confers tolerance to sulfonylurea. This trait was used as a marker in the selection of transformants.

(a)

In accordance with Article 19(3)(b) of Directive 2001/18/EC, the period of validity of the consent shall be 10 years starting from the date on which the consent is issued;

(b)

The unique identifier of the product shall be IFD-26407-2;

(c)

Without prejudice to Article 25 of Directive 2001/18/EC, the methodology for detecting and identifying the product, including experimental data demonstrating the specificity of the methodology as single-laboratory validated by the European Union Reference Laboratory is publicly available at http://gmo-crl.jrc.ec.europa.eu/valid-2001-18.htm;

(d)

Without prejudice to Article 25 of Directive 2001/18/EC, the consent holder shall, whenever requested to do so, make positive and negative control samples of the product, or its genetic material, or reference materials available to the competent authorities and to inspection services of Member States as well as to EU control laboratories;

(e)

The words ‘This product is a genetically modified organism’ or ‘This product is a genetically modified carnation’, and the words ‘not for human or animal consumption nor for cultivation’ shall appear either on a label or in a document accompanying the product.

(a)

that the existing monitoring networks, including national botanic survey networks and plant protection services, as specified in the monitoring plan contained in the notification, gather the information relevant for the monitoring of the products; and

(b)

that these existing monitoring networks referred to in point (a) have agreed to make available that information to the consent holder before the date of submission of the monitoring reports to the Commission and competent authorities of the Member States in accordance with paragraph 3.

30.4.2015   

EN

Official Journal of the European Union

L 112/56

(1)

On 30 November 2004, Monsanto Europe S.A. submitted to the competent authority of the United Kingdom an application in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 for the placing on the market of food and feed cottonseed oil and its constituents produced from genetically modified cotton MON 531 x MON 1445.

(2)

Food additives, feed materials and feed additives produced from genetically modified cotton MON 531 x MON 1445 were placed on the market before the entry into force of Regulation (EC) No 1829/2003 and were notified as existing products in accordance with Articles 8(1)(b) and 20(1)(b) of that Regulation.

(3)

On 17 April 2007, Monsanto Europe S.A. submitted to the Commission an application in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003 for the renewal of the authorisation for existing food additives, feed materials and feed additives produced from genetically modified cotton MON 531 x MON 1445 cotton.

(4)

The scope of the two applications, taken together, covers the full range of current commercial uses of food and feed produced from cotton as defined in Articles 3(1)(c) and 15(1)(c) of Regulation (EC) No 1829/2003.

(5)

On 28 March 2012, the European Food Safety Authority (‘EFSA’) gave a favourable opinion (2) in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that products derived from genetically modified cotton MON 531 x MON 1445 are as safe as products derived from the conventional counterpart, in the context of their intended uses.

(6)

EFSA concluded that the analysis of horizontal gene transfer from genetically modified cotton MON 531 x MON 1445 to bacteria did not indicate a risk to human or animal health or to the environment in the context of its intended uses, considering the expected low frequency of gene transfer from plant to bacteria compared with that between bacteria, and the very low exposure to DNA from genetically modified cotton MON 531 x MON 1445.

(7)

EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.

(8)

Consequently, authorisation should be granted for the products produced from genetically modified cotton MON 531 x MON 1445.

(9)

A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004 (3).

(10)

On the basis of the EFSA opinion, no specific labelling requirements, other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed produced from genetically modified cotton MON 531 x MON 1445.

(11)

All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.

(12)

This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and Article 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (4).

(13)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

(a)

food produced from MON-ØØ531-6 x MON-Ø1445-2 cotton;

(b)

feed produced from MON-ØØ531-6 x MON-Ø1445-2 cotton.

30.4.2015   

EN

Official Journal of the European Union

L 112/60

(1)

On 18 February 2010, Monsanto Europe SA submitted to the competent authority of The Netherlands an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from soybean MON87705 (‘the application’).

(2)

The application also covers the placing on the market of soybean MON87705 in products consisting of it or containing it for any other uses than food and feed as any other soybean, with the exception of cultivation.

(3)

In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council (2) and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

(4)

On 30 October 2012, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 (3). It concluded that soybean MON87705, as described in the application, is as safe as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses as proposed by the applicant. These uses covered all food and feed uses as any conventional soybean except for the commercial frying uses of the oil.

(5)

In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.

(6)

In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.

(7)

Subsequently, the Commission mandated EFSA to complement its opinion to include commercial frying uses of the oil derived from MON87705, requesting the necessary information from the applicant, if needed.

(8)

On 17 December 2013, EFSA issued a statement (4), complementing its initial opinion with the oil derived from MON87705 soybean for commercial frying and concluded that the updated nutritional assessment covering all food uses of soybean MON87705 oil does not impact on human health and nutrition.

(9)

In addition to that, EFSA recommended in this complementing statement a post-market monitoring plan to be implemented, focusing on the collection of consumption data for the European population.

(10)

Taking into account those considerations, authorisation should be granted to the products.

(11)

A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004 (5).

(12)

Food, food ingredients and feed containing, consisting of, or produced from MON87705 soybean should be labelled in accordance with the requirements provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003.

(13)

On the basis of the EFSA opinion, confirming that fatty acid composition of the seeds of MON87705 soybean and derived oil has been changed in relation to the conventional counterpart, a specific labelling appears to be necessary in accordance with Articles 13(2)(a) and 25(2)(c) of Regulation (EC) No 1829/2003.

(14)

In order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of products containing or consisting of the GMO for which authorisation is requested, with the exception of food products, should be complemented by a clear indication that the products in question must not be used for cultivation.

(15)

Regulation (EC) No 1830/2003 of the European Parliament and of the Council (6) lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.

(16)

The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC (7). The EFSA opinion does not justify the imposition of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Article 6(5) and Article 18(5) of Regulation (EC) No 1829/2003.

(17)

The authorisation holder should also submit annual reports on the implementation and the results of the activities set out in the post-market monitoring plan.

(18)

All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.

(19)

This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and point (c) of Article 15(2) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (8).

(20)

The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

(a)

foods and food ingredients containing, consisting of, or produced from MON-877Ø5-6 soybean;

(b)

feed containing, consisting of, or produced from MON-877Ø5-6 soybean;

(c)

MON-877Ø5-6 soybean in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.

30.4.2015   

EN

Official Journal of the European Union

L 112/66

(1)

On 17 April 2007, Bayer CropScience submitted to the competent authority of The Netherlands an application, in accordance with Article 5 and Article 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from T25 maize.

(2)

The application also covers the placing on the market of T25 maize in products consisting of it or containing it for any other uses than food and feed as any other maize, including the seeds for cultivation.

(3)

In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council (2) and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

(4)

On 17 April 2007, Bayer CropScience submitted to the European Commission an application, in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003, for the renewal of the authorisation of food and food ingredients produced from T25 maize, feed containing and consisting of genetically modified T25 maize, feed produced from T25 maize (feed materials and feed additives) and seeds from T25 maize for cultivation which were previously notified as existing products in accordance with Article 8(1)(a) and Article 20(1)(a) of that Regulation.

(5)

On 11 January 2013, Bayer CropScience informed the European Commission of its decision to amend the scope of the above-mentioned applications to no longer include the authorisation of seeds from T25 maize for cultivation in the European Union.

(6)

On 3 October 2013, the European Food Safety Authority (‘EFSA’) gave a favourable opinion for both new and renewal applications in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that T25 maize, as described in the applications, is as safe as its conventional counterpart with respect to potential effects on human and animal health and the environment, in the context of its intended use (3). In its opinion, EFSA also considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Article 6(4) and Article 18(4) of that Regulation.

(7)

In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.

(8)

Taking into account those considerations, authorisation should be granted for the products.

(9)

A unique identifier should be assigned to each genetically modified organism (hereinafter ‘GMO’) as provided for in Commission Regulation (EC) No 65/2004 (4).

(10)

On the basis of the EFSA opinion, no specific labelling requirements other than those provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from T25 maize. However, in order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of products containing or consisting of the GMO with the exception of food products for which authorisation is requested should be complemented by a clear indication that the products in question must not be used for cultivation.

(11)

Regulation (EC) No 1830/2003 of the European Parliament and of the Council (5), lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.

(12)

The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC (6). The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Article 6(5) and Article 18(5) of Regulation (EC) No 1829/2003.

(13)

All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.

(14)

This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and Article 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (7).

(15)

The applicant has been consulted on the measures provided for in this Decision.

(16)

The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time-limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

(a)

foods and food ingredients containing, consisting of, or produced from ACS-ZMØØ3-2 maize;

(b)

feed containing, consisting of, or produced from ACS-ZMØØ3-2 maize;

(c)

ACS-ZMØØ3-2 maize in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.

30.4.2015   

EN

Official Journal of the European Union

L 112/71

(1)

On 14 June 2007, Pioneer Overseas Corporation submitted to the competent authority of the Netherlands an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from 305423 soybean (‘the application’).

(2)

The application also covers the placing on the market of 305423 soybean in products consisting of it or containing it for any other uses than food and feed as any other soybean, with the exception of cultivation.

(3)

In accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council (2) and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

(4)

On 18 December 2013, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 (3). It concluded that 305423 soybean, as described in the application, is as safe as its non-genetically modified counterpart with respect to potential effects on human and animal health or the environment in the context of its intended uses.

(5)

In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.

(6)

In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products. In addition, EFSA recommended a post-market monitoring plan to be implemented, focusing on the collection of consumption data for the European population.

(7)

Taking into account those considerations, authorisation should be granted to the products.

(8)

A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004 (4).

(9)

Food, food ingredients and feed containing, consisting of, or produced from soybean 305423 should be labelled in accordance with the requirements provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003.

(10)

On the basis of the EFSA opinion, confirming that fatty acid composition of the seeds of soybean 305423 and derived oil has been changed in relation to the conventional counterpart, a specific labelling appears to be necessary in accordance with Articles 13(2)(a) and 25(2)(c) of Regulation (EC) No 1829/2003.

(11)

In order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of products containing or consisting of the GMO for which authorisation is requested, with the exception of food products, should be complemented by a clear indication that the products in question must not be used for cultivation.

(12)

Regulation (EC) No 1830/2003 of the European Parliament and of the Council (5) lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.

(13)

The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC (6). The EFSA opinion does not justify the imposition of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Article 6(5) and Article 18(5) of Regulation (EC) No 1829/2003.

(14)

The authorisation holder should also submit annual reports on the implementation and the results of the activities set out in the post-market monitoring plan.

(15)

All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.

(16)

This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and point (c) of Article 15(2) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (7).

(17)

The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

(a)

foods and food ingredients containing, consisting of, or produced from DP-3Ø5423-1 soybean;

(b)

feed containing, consisting of, or produced from DP-3Ø5423-1 soybean;

(c)

DP-3Ø5423-1 soybean in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.

30.4.2015   

EN

Official Journal of the European Union

L 112/77

(1)

On 29 March 2011, Bayer CropScience AG submitted to the competent authority of the Netherlands an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from T304-40 cotton (‘the application’).

(2)

The application also covers the placing on the market of T304-40 cotton in products consisting of it or containing it for other uses than food and feed as any other cotton, with the exception of cultivation.

(3)

In accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council (2) and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

(4)

On 20 June 2013, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that T304-40 cotton, as described in the application, is as safe as its non-genetically modified counterpart with respect to potential effects on human and animal health or the environment in the context of its intended uses (3).

(5)

In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.

(6)

In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.

(7)

Taking into account those considerations, authorisation should be granted to the products.

(8)

A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004 (4).

(9)

On the basis of the EFSA opinion, no specific labelling requirements, other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from T304-40 cotton. However, in order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of products containing or consisting of the GMO for which authorisation is requested, with the exception of food products, should be complemented by a clear indication that the products in question must not be used for cultivation.

(10)

Regulation (EC) No 1830/2003 of the European Parliament and of the Council (5) lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.

(11)

The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC (6). The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Article 6(5) and Article 18(5) of Regulation (EC) No 1829/2003.

(12)

All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.

(13)

This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and point (c) of Article 15(2) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (7).

(14)

The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

(a)

foods and food ingredients containing, consisting of, or produced from BCS-GHØØ4-7 cotton;

(b)

feed containing, consisting of, or produced from BCS-GHØØ4-7 cotton;

(c)

BCS-GHØØ4-7 cotton in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.

30.4.2015   

EN

Official Journal of the European Union

L 112/81

(1)

On 2 February 2011, Monsanto Europe S.A. submitted to the competent authority of the Netherlands an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from soybean MON87708 (‘the application’).

(2)

The application also covers the placing on the market of soybean MON87708 in products consisting of it or containing it for any other uses than food and feed as any other soybean, with the exception of cultivation.

(3)

In accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council (2) and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

(4)

On 3 October 2013, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that soybean MON87708, as described in the application, is as safe as its non-genetically modified counterpart and reference varieties with respect to potential effects on human and animal health or the environment, in the context of its intended uses (3).

(5)

In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of that Regulation.

(6)

In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.

(7)

Taking into account those considerations, authorisation should be granted to the products containing, consisting of, or produced from genetically modified soybean MON87708.

(8)

A unique identifier should be assigned to each genetically modified organism (hereinafter ‘GMO’) as provided for in Commission Regulation (EC) No 65/2004 (4).

(9)

On the basis of the EFSA opinion, no specific labelling requirements, other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from soybean MON87708. However, in order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of products containing or consisting of the GMO for which authorisation is requested, with the exception of food products, should be complemented by a clear indication that the products in question must not be used for cultivation.

(10)

Regulation (EC) No 1830/2003 of the European Parliament and of the Council (5) lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.

(11)

The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC (6). The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Article 6(5) and Article 18(5) of Regulation (EC) No 1829/2003.

(12)

All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.

(13)

This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and Article 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (7).

(14)

The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

(a)

foods and food ingredients containing, consisting of, or produced from soybean MON-877Ø8-9;

(b)

feed containing, consisting of, or produced from soybean MON-877Ø8-9;

(c)

soybean MON-877Ø8-9 in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.

30.4.2015   

EN

Official Journal of the European Union

L 112/86

(1)

On 17 and 18 April 2007, Monsanto Europe SA submitted to the Commission applications, in accordance with Article 8(4) and Article 20(4) of Regulation (EC) No 1829/2003, for renewal of the authorisations of existing food and feed produced from GT73 oilseed rape. The scope of the two renewal applications covers the continued marketing of existing food produced from oilseed rape GT73 (refined oil and food additives) and existing feed produced from oilseed rape GT73 (feed materials and feed additives) which were lawfully placed on the market in the Community before the date of entry into force of Regulation (EC) No 1829/2003. After the date of the entry into force of Regulation (EC) No 1829/2003, these products were notified to the European Commission according to Articles 8(1)(a), 8(1)(b) and 20(1)(b) of that Regulation and included in the Community Register of genetically modified food and feed.

(2)

On 15 December 2009, the European Food Safety Authority (‘EFSA’) gave a favourable opinion on the renewal application in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that it is unlikely that the continued marketing of the food and feed produced from oilseed rape GT73 as described in the application will have any adverse effects on human or animal health or the environment, in the context of their intended uses (2).

(3)

On 26 August 2010, Monsanto Europe SA submitted to the competent authority of the Netherlands an application, in accordance with Article 5 of Regulation (EC) No 1829/2003, for the placing on the market of foods and food ingredients containing, consisting of, or produced from oilseed rape GT73 (including pollen of oilseed rape GT73 and the accidental unintentional presence of viable seeds), with the exception of processed oil and food additives. The application does not include cultivation in the EU.

(4)

In accordance with Article 5(5) of Regulation (EC) No 1829/2003, that application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council (3), and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

(5)

On 12 February 2013, EFSA gave a favourable opinion on the new application in accordance with Article 6 Regulation (EC) No 1829/2003. It concluded that there is no indication of safety concerns for the human health in the context of the uses covered by the application, and in particular in either oilseed rape GT73 pollen/pollen-containing dietary supplements or the adventitious presence of trace levels of seeds in human foods (4). However, due to the lack of availability of relevant consumption and safety data, EFSA could not perform an equivalent assessment with isolated seed protein. EFSA also concluded that the environmental risk assessment of GT73 did not identify any safety concerns, in the context of its intended uses.