(1)

Benchmarks play an important role in the determination of the price of many financial instruments and financial contracts and of the measurement of performance for many investment funds. The contribution to and administration of benchmarks are in many cases vulnerable to manipulation and persons involved often face conflict of interests.

(2)

In order to fulfil their economic role, benchmarks need to be representative of the underlying market or economic reality they reflect. Should a benchmark no longer be representative of an underlying market, such as interbank offered rates, there is a risk of negative effects on, inter alia, market integrity, the financing of households (loans and mortgages) and businesses in the Union.

(3)

Risks to users, markets and the economy of the Union generally increase where the total value of financial instruments, financial contracts and investment funds referencing a specific benchmark is high. Regulation (EU) 2016/1011 therefore establishes different categories of benchmarks and provides for additional requirements ensuring the integrity and robustness of certain benchmarks considered as being critical, including the power of competent authorities to mandate, under certain conditions, contributions to or the administration of a critical benchmark.

(4)

The additional obligations and powers of competent authorities of administrators of critical benchmarks require a formal process for the determination of critical benchmarks. In accordance with Article 20(1)(a) of Regulation (EU) 2016/1011, a benchmark is considered as being a critical benchmark where it is used directly or indirectly within a combination of benchmarks as a reference for financial instruments or financial contracts or for measuring the performance of investment funds, having a total value of at least EUR 500 billion on the basis of all the ranges of maturities or tenors of the benchmark, where applicable.

(5)

The London Interbank Offered Rate (LIBOR) measures unsecured inter-bank offered rates in five currencies, including the Euro, with seven maturities ranging from overnight to 12 months. It is one of the most important interest rate benchmark worldwide. It is used as the floating rate for many financial contracts, from interest rate swaps to student loans, mortgages and corporate funding instruments.

(6)

The Financial Conduct Authority (FCA) has identified approximately USD 156,8 trillion in over-the-counter derivatives that made a reference to LIBOR in October 2016.

(7)

In addition, the FCA points out that there is significant reference to LIBOR in exchange traded derivatives, bond and corporate debt markets and that these exposures are relevant with regard to systemic risk and the real economy.

(8)

The list of critical benchmarks established by Commission Implementing Regulation (EU) 2016/1368 (2) should therefore be amended by adding LIBOR.

(9)

In light of the importance of LIBOR for interbank market and the high number of financial instruments in the Union referencing it, this Regulation should enter into force as a matter of urgency.

(10)

In accordance with Article 20(1) of Regulation (EU) 2016/1011, the applicability of this Regulation is dependent on the administrator providing a critical benchmark being located within the Union.

(11)

The measures provided for in this Regulation are in accordance with the opinion of the European Securities Committee,

(1)

Commission Regulation (EC) No 1484/95 (3) lays down detailed rules for implementing the system of additional import duties and fixes representative prices in the poultrymeat and egg sectors and for egg albumin.

(2)

Regular monitoring of the data used to determine representative prices for poultrymeat and egg products and for egg albumin shows that the representative import prices for certain products should be amended to take account of variations in price according to origin.

(3)

Regulation (EC) No 1484/95 should therefore be amended accordingly.

(4)

Given the need to ensure that this measure applies as soon as possible after the updated data have been made available, this Regulation should enter into force on the day of its publication,

(1)

On 20 September 2007, Pioneer Overseas Corporation submitted an application for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from 305423 × 40-3-2 soybean (‘the application’) to the national competent authority of the Netherlands in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003. The application also covered the placing on the market of genetically modified soybean 305423 × 40-3-2 in products consisting of it or containing it for other uses than food and feed as any other soybean, with the exception of cultivation.

(2)

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

(3)

On 18 August 2016, the European Food Safety Authority (‘EFSA’) gave a favourable opinion (3) in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. EFSA concluded that genetically modified soybean 305423 × 40-3-2, as described in the application, is as safe as the non-genetically modified comparator and other non-genetically modified conventional soybean varieties as regards the potential effects on human and animal health and the environment in the context of the scope of the application.

(4)

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.

(5)

In its opinion, 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.

(6)

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

(7)

Taking into account those considerations, authorisation should be granted to the products containing, consisting of, or produced from genetically modified soybean 305423 × 40-3-2.

(8)

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

(9)

Food, food ingredients and feed containing, consisting of, or produced from 305423 × 40-3-2 soybean should be labelled in accordance with the requirements laid down in Article 13(1) and Article 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 305423 × 40-3-2 soybean and derived oil has been changed in relation to the conventional counterpart, specific labelling should be included in accordance with Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003.

(11)

On the basis of the EFSA opinion, no specific labelling requirements, other than those laid down in Article 13(1) and in Article 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council (5), appear necessary for the products covered by this Decision. 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.

(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 the standard reporting format requirements laid down in Commission Decision 2009/770/EC (6).

(13)

The EFSA opinion does not justify either the imposition of specific conditions for the protection of particular ecosystems/environments or geographical areas, as provided for in Article 6(5)(e) and Article 18(5)(e) 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 Article 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (7).

(17)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. This implementing act was deemed to be necessary and the chair submitted it 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 × MON-Ø4Ø32-6 soybean;

(b)

feed containing, consisting of, or produced from DP-3Ø5423-1 × MON-Ø4Ø32-6 soybean;

(c)

DP-3Ø5423-1 × MON-Ø4Ø32-6 soybean 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.

(1)

Regulation (EC) No 1829/2003 lays down authorisation procedures for genetically modified food and feed. On 25 January 2011, Dow AgroSciences Europe submitted an application for the placing on the market of foods, food ingredients and feed containing, consisting of, or produced from genetically modified DAS-68416-4 soybean to the national competent authority of the Netherlands in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003. The application also covered the placing on the market of genetically modified soybean DAS-68416-4 in products consisting of it or containing it for other uses than food and feed as any other soybean, with the exception of cultivation.

(2)

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

(3)

On 17 March 2017, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 (3). EFSA concluded that genetically modified soybean DAS-68416-4, as described in the application, is as safe and as nutritious as its conventional counterpart and non-genetically modified commercial varieties with regard to potential effects on human and animal health and the environment.

(4)

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.

(5)

In addition, EFSA 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.

(6)

Taking into account those considerations, authorisation should be granted to the products containing, consisting of, or produced from genetically modified soybean DAS-68416-4.

(7)

A unique identifier should be assigned to genetically modified soybean DAS-68416-4 in accordance with Commission Regulation (EC) No 65/2004 (4).

(8)

On the basis of the EFSA opinion, no specific labelling requirements, other than those laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council (5), appear to be necessary for the products covered by this Decision. 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 or consisting of soybean DAS-68416-4, with the exception of food products, should be complemented by a clear indication that the products in question are not intended for cultivation.

(9)

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 the standard reporting format requirements laid down in Commission Decision 2009/770/EC (6).

(10)

The EFSA opinion does not justify the imposition of specific conditions for the protection of particular ecosystems/environments and geographical areas, as provided for in Article 6(5)(e) 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 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 (7).

(13)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. This implementing act was deemed to be necessary and the chair submitted it 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 DAS-68416-4;

(b)

feed containing, consisting of, or produced from soybean DAS-68416-4;

(c)

soybean DAS-68416-4 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.

(1)

Regulation (EC) No 1829/2003 lays down authorisation procedures for genetically modified food and feed. On 16 February 2012, Dow AgroSciences LLC and M.S. Technologies LLC submitted an application for the placing on the market of foods, food ingredients and feed containing, consisting of, or produced from genetically modified soybean DAS-44406-6 to the national competent authority of the Netherlands in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003. The application also covered the placing on the market of genetically modified soybean DAS-44406-6 in products consisting of it or containing it for other uses than food and feed as any other soybean, with the exception of cultivation.

(2)

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

(3)

On 21 March 2017, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 (3). EFSA concluded that genetically modified soybean DAS-44406-6, as described in the application, is as safe and nutritious as its conventional counterpart and non-genetically modified reference varieties with respect to potential effects on human and animal health and the environment.

(4)

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.

(5)

In addition, 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.

(6)

Taking into account those considerations, the placing on the market of products containing, consisting of, or produced from genetically modified soybean DAS-44406-6 for the uses listed in the application should be authorised.

(7)

A unique identifier should be assigned to genetically modified soybean DAS-44406-6 in accordance with Commission Regulation (EC) No 65/2004 (4).

(8)

On the basis of the EFSA opinion, no specific labelling requirements, other than those laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council (5), appear to be necessary for the products covered by this Decision. 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 or consisting of genetically modified soybean DAS-44406-6, with the exception of food products, should be complemented by a clear indication that the products in question are not intended for cultivation.

(9)

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 the standard reporting format requirements laid down in Commission Decision 2009/770/EC (6).

(10)

The EFSA opinion does not justify the imposition of specific conditions for the protection of particular ecosystems/environments and geographical areas, as provided for in Article 6(5)(e) 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 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 (7).

(13)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. This implementing act was deemed to be necessary and the chair submitted it 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 DAS-44406-6;

(b)

feed containing, consisting of, or produced from soybean DAS-44406-6;

(c)

soybean DAS-44406-6 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.

(1)

Regulation (EC) No 1829/2003 lays down authorisation procedures for genetically modified food and feed. On 10 December 2013, Bayer CropScience LP and M.S. Technologies, LLC submitted to the national competent authority of the Netherlands, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, an application for the placing on the market of foods, food ingredients and feed containing, consisting of, or produced from genetically modified soybean FG72 × A5547-127. The application also covered the placing on the market of genetically modified soybean FG72 × A5547-127 in products consisting of it or containing it for other uses than food and feed as any other soybean, with the exception of cultivation.

(2)

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

(3)

On 6 April 2017, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. EFSA concluded that genetically modified soybean FG72 × A5547-127, as described in the application, is as safe as the non-genetically modified comparator and non-genetically modified soybean reference 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 from genetically modified soybean FG72 × A5547-127 as or in feed, as no compositional data on forage was submitted by the applicants. That use should therefore be excluded from the scope of this authorisation. Since forage is usually used where the cultivation takes place, no import is expected thereof in the Union and the exclusion of forage from the scope of the authorisation does not need to be accompanied by further measures.

(4)

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.

(5)

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

(6)

Taking into account those considerations, the placing on the market of products containing, consisting of, or produced from genetically modified soybean FG72 × A5547-127 for the uses listed in the application, with the exception of the use of forage as or in feed, should be authorised.

(7)

A unique identifier should be assigned to genetically modified soybean FG72 × A5547-127 in accordance with Commission Regulation (EC) No 65/2004 (4).

(8)

On the basis of the EFSA opinion, no specific labelling requirements, other than those laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council (5), appear to be necessary for the products covered by this Decision. 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 or consisting of genetically modified soybean FG72 × A5547-127, with the exception of food products, should contain a clear indication that the products in question are not intended for cultivation.

(9)

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 the standard reporting format requirements laid down in Commission Decision 2009/770/EC (6).

(10)

The EFSA opinion does not justify the imposition of specific conditions for the protection of particular ecosystems/environments and geographical areas, as provided for in Article 6(5)(e) 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 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 (7).

(13)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. This implementing act was deemed to be necessary and the chair submitted it 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 FG72 × A5547-127;

(b)

feed containing, consisting of, or produced from soybean FG72 × A5547-127 with the exception of forage;

(c)

soybean FG72 × A5547-127, 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.

(1)

On 27 February 2015, Pioneer Overseas Corporation and Dow AgroSciences Ltd jointly submitted to the Commission an application, in accordance with Article 11 and Article 23 of Regulation (EC) No 1829/2003, for renewal of the authorisation for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from genetically modified maize 1507 (hereinafter ‘maize 1507’). The scope of the renewal application also covers products other than food and feed containing or consisting of maize 1507. The scope of the application does not include cultivation.

(2)

The placing on the market of the products covered by the scope of the renewal application was previously authorised by two separate decisions: Commission Decision 2005/772/EC (2) and Commission Decision 2006/197/EC (3).

(3)

On 12 January 2017, the European Food Safety Authority (‘EFSA’) issued a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. Based on the data provided, it concluded (4) that no new hazards or modified exposure and no new scientific uncertainties were identified for the application for renewal that would change the conclusions of the original risk assessment (5) on maize 1507.

(4)

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.

(5)

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.

(6)

Taking into account those considerations, the authorisation for the placing on the market of food and feed containing, consisting of, or produced from maize 1507 and of products consisting of it or containing it for other uses than food or feed, with the exception of cultivation, should be renewed.

(7)

A unique identifier has been assigned to genetically modified maize 1507, in accordance with Commission Regulation (EC) No 65/2004 (6), by Decision 2005/772/EC. That unique identifier should continue to be used.

(8)

On the basis of the abovementioned EFSA opinion, no specific labelling requirements, other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council (7), appear to be necessary for the products covered by this Decision. However, in order to ensure the use of those products remains within the limits of the authorisation granted by this Decision, the labelling of the products containing or consisting of maize 1507, with the exception of food products, should contain a clear indication that the products in question are not intended for cultivation. Since an application for the authorisation for the placing on the market of maize 1507 seeds for cultivation is pending, this labelling requirement should only apply until that authorisation is granted.

(9)

The authorisation holders should submit joint annual reports on the implementation and the results of the activities set out in the monitoring plan. These results should be presented in accordance with Commission Decision 2009/770/EC (8).

(10)

The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or the use and handling of the food and feed, including post-market monitoring requirements.

(11)

All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed referred to 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 (9).

(13)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. This implementing act was deemed to be necessary and the chair submitted it 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 maize 1507;

(b)

feed containing, consisting of or produced from maize 1507;

(c)

maize 1507 in products containing it or consisting of it for any other use than those provided for in points (a) and (b), with the exception of cultivation.

(a)

Pioneer Overseas Corporation, Avenue des Arts 44, B-1040 Brussels — Belgium, and

(b)

Dow AgroSciences Europe Ltd., European Development Center, 3B Park Square, Milton Park, Abingdon, Oxon OX14 4RN — United Kingdom.

(1)

On 3 December 2013, Monsanto Europe S.A. and Bayer CropScience N.V. submitted an application for the placing on the market of foods, food ingredients and feed containing, consisting of, or produced from genetically modified oilseed rape MON 88302 × Ms8 × Rf3 to the national competent authority of the Netherlands in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003. The application also covered the placing on the market of genetically modified oilseed rape MON 88302 × Ms8 × Rf3 in products consisting of it or containing it for other uses than food and feed as any other oilseed rape, with the exception of cultivation. The application covered, for those uses, all sub-combinations of the single genetic modification events constituting oilseed rape MON 88302 × Ms8 × Rf3.

(2)

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

(3)

On 10 April 2017, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 (3). EFSA concluded that genetically modified oilseed rape MON 88302 × Ms8 × Rf3, as described in the application, is as safe and nutritious as its conventional counterpart and non-genetically modified reference varieties as respect to potential effects on human and animal health and the environment, and no safety concerns were identified for the sub-combinations covered by the scope of the application.

(4)

On 23 May 2017, Monsanto Europe S.A. and Bayer CropScience N.V. updated the scope of the application by excluding the sub-combination Ms8 × Rf3, which is already authorised by Commission Decision 2007/232/EC (4) and Commission Implementing Decision 2013/327/EU (5).

(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 Article 18(4) of Regulation (EC) No 1829/2003.

(6)

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.

(7)

Taking into account those considerations, the placing on the market of products containing, consisting of, or produced from genetically modified oilseed rapes MON 88302 × Ms8 × Rf3, MON 88302 × Ms8 and MON 88302 × Rf3, for the uses listed in the application should be authorised.

(8)

A unique identifier should be assigned to each genetically modified organism (hereinafter ‘GMO’) in accordance with Commission Regulation (EC) No 65/2004 (6).

(9)

On the basis of the EFSA opinion, no specific labelling requirements, other than those laid down in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council (7), appear to be necessary for the products covered by this Decision. 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 or consisting of genetically modified oilseed rapes MON 88302 × Ms8 × Rf3, MON 88302 × Ms8 and MON 88302 × Rf3, with the exception of food products, should be complemented by a clear indication that the products in question are not intended for cultivation.

(10)

The authorisation holders 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 the standard reporting format requirements laid down in Commission Decision 2009/770/EC (8).

(11)

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.

(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 Articles 9(1) and Article 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (9).

(14)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. This implementing act was deemed to be necessary and the chair submitted it 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 the GMOs referred to in Article 1(1);

(b)

feed containing, consisting of, or produced from the GMOs referred to in Article 1(1);

(c)

GMOs referred to in Article 1(1) in products containing them or consisting of them for any other use than those provided in points (a) and (b), with the exception of cultivation.

(a)

Monsanto Europe S.A., Avenue de Tervuren 270-272, B-1150 Brussels, Belgium;

and

(b)

Bayer CropScience N.V., J.E. Mommaertslaan 14, 1831, Diegem, Belgium.