(1)

Pursuant to the first subparagraph of Article 8(2) of Regulation (EC) No 509/2006 and Article 19(3) thereof, the United Kingdom’s application to register the name ‘Traditionally Farmed Gloucestershire Old Spots Pork’ was published in the Official Journal of the European Union (2).

(2)

As no objection under Article 9 of Regulation (EC) No 509/2006 has been received by the Commission, this name should be entered in the register.

(3)

The application also requested protection under Article 13(2) of Regulation (EC) No 509/2006. That protection should be granted to the name ‘Traditionally Farmed Gloucestershire Old Spots Pork’ in so far as, in the absence of objections, it could not be demonstrated that the name is used in a lawful, renowned and economically significant manner for similar agricultural products or foodstuffs,

(1)

Commission Regulation (EC) No 748/2008 of 30 July 2008 on the opening and administration of an import tariff quota for frozen thin skirt of bovine animals falling within CN code 0206 29 91  (3) opens an import tariff quota for beef and veal products.

(2)

The applications for import licences lodged for the period 1 July 2010 to 30 June 2011 relate to quantities exceeding those available. The extent to which import licences may be issued should therefore be determined and an allocation coefficient laid down to be applied to the quantities applied for,

(1)

The import duties in the cereals sector applicable from 16 July 2010 were fixed by Commission Regulation (EU) No 626/2010 (3).

(2)

As the average of the import duties calculated differs by more than EUR 5/tonne from that fixed, a corresponding adjustment must be made to the import duties fixed by Regulation (EU) No 626/2010.

(3)

Regulation (EU) No 626/2010 should therefore be amended accordingly,

(1)

Outbreaks of bluetongue occurred in Spain in 2004 and 2005. The emergence of that disease presented a serious risk to the Union’s livestock population.

(2)

Commission Decision 2005/650/EC of 13 September 2005 concerning a financial contribution by the Community in the context of the emergency measures taken to combat bluetongue in Spain in 2004 and 2005 (2) granted a financial contribution from the Community to Spain towards the expenditure incurred under the emergency measures to combat bluetongue in 2004 and 2005.

(3)

That Decision provided for a first instalment of EUR 2 500 000 subject to the results of the Commission in situ inspections.

(4)

Pursuant to Article 6(2) of that Decision, the balance of the Union financial contribution is to be paid on the basis of the application submitted within 60 days of that Decision. Spain submitted that application on 11 November 2005.

(5)

Pursuant to Article 4(2) of Decision 2005/650/EC, the balance of the Union financial contribution should now be fixed through a Commission decision to be adopted in accordance with the procedure of Article 40 of Decision 2009/470/EC.

(6)

The results of the inspections carried out by the Commission in compliance with Article 7 of Decision 2005/650/EC and the conditions for granting Union’s financial contributions mean the entire amount of the expenditure submitted cannot be recognised as eligible.

(7)

The Commission’s observations, method of calculating the eligible expenditure and final conclusions were communicated to Spain in a letter dated 1 July 2009.

(8)

In view of the above considerations, the total amount of the Union’s financial contribution to the eligible expenditure incurred associated with the eradication and surveillance of bluetongue in Spain in 2004 and 2005 should now be fixed.

(9)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

(1)

On 17 April 2007, Syngenta Seeds SAS on behalf of Syngenta Crop Protection AG, submitted to the Commission an application, in accordance with Articles 5, 11, 17 and 23 of Regulation (EC) No 1829/2003, for renewal of the authorisation for continued marketing of existing foods and food ingredients produced from Bt11 maize (including food additives), and renewal of the authorisation for continued marketing of existing feed containing, consisting of or produced from Bt11 maize (including feed additives and feed materials) and products other than food and feed containing and consisting of Bt11 maize with the exception of cultivation (the application) which were previously notified in accordance with Article 8(1)(a)(b) and Article 20(1)(a)(b) of that Regulation. The application also covers the renewal of the authorisation for the placing on the market of foods and food ingredients which are authorised under Commission Decision 2004/657/EC of 19 May 2004 authorising the placing on the market of sweet corn from genetically modified maize line Bt11 as a novel food or novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (2). Within its application, Syngenta Seeds SAS also requested the authorisation of foods and food ingredients containing or consisting of Bt11 field maize which were never authorised in the Union.

(2)

On 17 February 2009, the European Food Safety Authority (EFSA) gave a favourable opinion (3) in accordance with Article 6 and Article 18 of Regulation (EC) No 1829/2003 and concluded that the new information provided in the application and the review of the literature that has been published since the previous scientific opinion on Bt11 maize (4) by EFSA does not require changes and confirmed the previous conclusion that Bt11 maize is as safe as its non-genetically modified counterpart and that it is unlikely to have an adverse effect on human and animal health or the environment in the context of its proposed uses which also applies to the products which are subject of the application.

(3)

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.

(4)

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 use of the products.

(5)

Taking into account these considerations, the fact that the company Syngenta Crop Protection AG Switzerland which absorbed Syngenta Seeds AG, addressee of Decision 2004/657/EC is the same legal entity, on behalf of which the applicant asked for the renewal of authorisation, that it confirmed that the scope of its application also covers the request for authorisation of foods and food ingredients containing or consisting of Bt11 field maize and that it intended to ask for a renewal of products covered by Decision 2004/657/EC prior to the expiration of the authorisation mentioned in that Decision so that a single Decision covering these products may be adopted which will take effect on the same date, renewal of the authorisation for continued marketing of the existing products, renewal of the authorisation of foods and food ingredients containing, consisting of or produced from Bt11 sweet maize (sweet maize fresh or canned) and authorisation of food and foods ingredients containing or consisting of Bt11 field maize should be granted. Consequently, Decision 2004/657/EC should be repealed.

(6)

A unique identifier should be assigned to each GMO as provided for in Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms (5).

(7)

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 Bt11 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 feed containing or consisting of the GMO and products other than food and feed containing or consisting of the GMO for which renewal of the authorisation is requested should be complemented by a clear indication that the products in question must not be used for cultivation.

(8)

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 of 13 October 2009 establishing standard reporting formats for presenting the monitoring results of the deliberate release into the environment of genetically modified organisms, as or in products, for the purpose of placing on the market, pursuant to Directive 2001/18/EC of the European Parliament and of the Council (6).

(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 Article 6(5)(e) and Article 18(5) of Regulation (EC) No 1829/2003.

(10)

All relevant information on the authorisation or the renewal 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.

(11)

Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (7), lays down labelling requirements for products consisting of, or containing GMOs.

(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 of 15 July 2003 on transboundary movements of genetically modified organisms (8).

(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.

(15)

At its meeting on 29 June 2010, the Council was unable to reach a decision by qualified majority either for or against the proposal. The Council indicated that its proceedings on this file were concluded. It is accordingly for the Commission to adopt the measures,

(a)

foods and food ingredients containing, consisting of or produced from SYN-BTØ11-1 maize;

(b)

feed containing, consisting of, or produced from SYN-BTØ11-1 maize;

(c)

products other than food and feed containing or consisting of SYN-BTØ11-1 maize for the same uses as any other maize with the exception of cultivation.

(1)

On 24 January 2007, 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 MON89034xNK603 maize (‘the application’).

(2)

The application also covers the placing on the market of products other than food and feed containing or consisting of MON89034xNK603 maize for the same uses as any other maize with the exception of cultivation. Therefore, in accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, it includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (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.

(3)

On 29 September 2009, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It considered that maize MON89034xNK603 is as safe as its non-genetically modified counterpart with respect to potential effects on human and animal health or the environment. Therefore it concluded that it is unlikely that the placing on the market of the products containing, consisting of, or produced from MON89034xNK603 maize as described in the application (‘the products’) will have any adverse effects on human or animal health or the environment in the context of their intended uses (3). 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.

(4)

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 use of the products.

(5)

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

(6)

A unique identifier should be assigned to each GMO as provided for in Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms (4).

(7)

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 MON89034xNK603 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 feed containing or consisting of the GMO and products other than food and feed containing or consisting of the GMO for which authorisation is requested should be complemented by a clear indication that the products in question must not be used for cultivation.

(8)

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 of 13 October 2009 establishing standard reporting formats for presenting the monitoring results of the deliberate release into the environment of genetically modified organisms, as or in products, for the purpose of placing on the market, pursuant to Directive 2001/18/EC of the European Parliament and of the Council (5).

(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 Article 6(5)(e) and Article 18(5) of Regulation (EC) No 1829/2003.

(10)

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.

(11)

Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (6), lays down labelling requirements for products containing or consisting of GMOs.

(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 of 15 July 2003 on transboundary movements of genetically modified organisms (7).

(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.

(15)

At its meeting on 29 June 2010, the Council was unable to reach a decision by qualified majority either for or against the proposal. The Council indicated that its proceedings on this file were concluded. It is accordingly for the Commission to adopt the measures,

(a)

foods and food ingredients containing, consisting of, or produced from MON-89Ø34-3xMON-ØØ6Ø3-6 maize;

(b)

feed containing, consisting of, or produced from MON-89Ø34-3xMON-ØØ6Ø3-6 maize;

(c)

products other than food and feed containing or consisting of MON-89Ø34-3xMON-ØØ6Ø3-6 maize for the same uses as any other maize with the exception of cultivation.