(1)

On 25 June 2010 the negotiating conference, established under the auspices of the United Nations Conference on Trade and Development, approved the text of the International Cocoa Agreement 2010 (‘the Agreement’).

(2)

The Agreement was negotiated to replace the International Cocoa Agreement 2001 (‘the 2001 Agreement’), which has been extended until 30 September 2012.

(3)

The Agreement is open for signature from 1 October 2010 until 30 September 2012 and the instruments of ratification, acceptance or approval may be deposited during the same period.

(4)

The aims of the Agreement fall under the common commercial policy.

(5)

The European Union is a party to the 2001 Agreement, and the signature of the Agreement and the deposit of its instrument of provisional application have already been authorised by Council Decision 2011/634/EU (1). It is therefore in the interest of the Union to conclude the Agreement,

(1)

Requests by Member States or on the initiative of the Commission, to initiate the procedure under Article 8(2) of Regulation (EC) No 1925/2006 to prohibit, restrict or place under Union scrutiny a substance other than vitamins or minerals, or an ingredient containing a substance other than vitamins or minerals that is added to foods or used in the manufacture of foods should meet certain conditions and uniform rules should be established for checking that these conditions are met. One of the conditions laid down in Article 8(1) of Regulation (EC) No 1925/2006 is that the intake of the substance should greatly exceed normal intake of a balanced and varied diet and it should present a potential risk to consumers as demonstrated by relevant scientific data. Further, Article 8(1) of Regulation (EC) No 1925/2006 provides that the procedure should also be applied where the substance presents a potential risk to health for reasons other than a great excess of its normal intake. In addition, Article 8(1) of Regulation (EC) No 1925/2006 provides that the substance should be added to foods or used in the manufacture of foods.

(2)

For the purpose of the application of the condition mentioned above, dietary intakes of the concerned substance that greatly exceed those expected under normal conditions of consumption of a balanced and varied diet should reflect actual intake of the substance and not a theoretical assumption of intake, and should be assessed on a case-by-case basis in comparison with the average level of intake of the substance by the general adult population or other population groups for which potential risks to consumers have been identified.

(3)

The Member State putting forward a request should provide the necessary information to demonstrate that the conditions required by Regulation (EC) No 1925/2006 are met. This should include information on the placing on the market of food products containing the substance and the available and relevant generally accepted scientific evidence that associates the substance with a potential risk to consumers. Only those requests ascertained as complete should be sent to the European Food Safety Authority (hereafter ‘the Authority’) for a safety assessment based on the available information. The Authority should adopt an opinion on the safety of the substance within a specified time limit as laid down in Article 29(3) of Regulation (EC) No 178/2002 of the European Parliament and of the Council (2). Interested parties should be allowed to submit comments to the Commission following the publication of the opinion by the Authority.

(4)

Article 8(4) of Regulation (EC) No 1925/2006 states that food business operators, or any other interested parties, may at any time submit for evaluation to the Authority a file containing the scientific data demonstrating the safety of a substance listed in Annex III, Part C to that Regulation, under the conditions of its use in a food or in a category of foods and explaining the purpose of that use. Any such file submitted by a food business operator or interested party should be based on guidance documents adopted or endorsed by the Authority, such as the guidance on submissions for safety evaluation of sources of nutrients or of other ingredients proposed for use in the manufacture of food, or any further revised version of such guidance.

(5)

In order for the Commission to take a decision concerning a substance included in Annex III, Part C to Regulation (EC) No 1925/2006 within the required deadline, it is necessary to take into consideration only those files submitted within 18 months from the date a substance has been included in that Annex. Furthermore, in order for the Commission to take a decision within the stipulated deadline, the Authority should give its opinion on the safety of the substance within a time limit of nine months from receiving a file that is considered to be valid and complete in accordance with the guidance documents adopted or endorsed by the Authority.

(6)

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

(a)

the conditions for the use of the procedure referred to in paragraphs 1 and 2 of Article 8 of Regulation (EC) No 1925/2006; and

(b)

the procedure referred to in paragraphs 4 and 5 of Article 8 of Regulation (EC) No 1925/2006 concerning substances listed in Annex III, Part C thereto.

(a)

‘request’ means the submission to the Commission by a Member State of information, including scientific data, for the purpose of initiating the procedure under paragraph 2 of Article 8 of Regulation (EC) No 1925/2006;

(b)

‘file’ means a file as referred to in paragraphs 4 and 5 of Article 8 of Regulation (EC) No 1925/2006 that is submitted by a food business operator or interested party to the Authority;

(c)

‘placing on the market’ as defined by Article 3(8) of Regulation (EC) No 178/2002.

(1)

As a result of the United States’ failure to bring the Continued Dumping and Subsidy Offset Act (CDSOA) in compliance with its obligations under the WTO agreements, Regulation (EC) No 673/2005 imposed a 15 % ad valorem additional customs duty on imports of certain products originating in the United States as from 1 May 2005. In conformity with the WTO authorisation to suspend the application of concessions to the United States, the Commission is to adjust the level of suspension annually to the level of nullification or impairment caused by the CDSOA to the European Union at that time.

(2)

The CDSOA disbursements for the most recent year for which data are available relate to the distribution of anti-dumping and countervailing duties collected during the Fiscal Year 2011 (1 October 2010 – 30 September 2011). On the basis of the data published by the United States’ Customs and Border Protection, the level of nullification or impairment caused to the Union is calculated at USD 3 241 000.

(3)

The level of nullification or impairment and consequently of suspension has decreased. However, the level of suspension cannot be adjusted to the level of nullification or impairment by adding or removing products from the list in Annex I to Regulation (EC) No 673/2005. As a consequence, in accordance with Article 3(1)(e) of that Regulation, the Commission should keep the list of products in Annex I unchanged and amend the rate of the additional duty in order to adjust the level of suspension to the level of nullification or impairment. The three products listed in Annex I should therefore be maintained on the list and the rate of additional import duty should be amended and set at 6 %.

(4)

The effect of a 6 % ad valorem additional import duty on imports from the United States of the products in Annex I represents, over one year, a value of trade that does not exceed USD 3 241 000.

(5)

To make sure that there are no delays in the application of the amended rate of additional import duty, this Implementing Regulation should enter into force on the day of its publication.

(6)

The measures provided for in this Implementing Regulation are in accordance with the opinion delivered by the Committee on Trade Retaliation,

(1)

Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

(2)

The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

(1)

On 17 July 2008 the Commission adopted Decision 2008/603/EC (2) granting a temporary derogation from the rules of origin laid down in Annex II to Regulation (EC) No 1528/2007 to take account of the special situation of Mauritius with regard to preserved tuna and tuna loins. By Commission Implementing Decision 2011/377/EU (3) extension of that temporary derogation was granted until 31 December 2011. On 6 October 2011 Mauritius requested in accordance with Article 36 of Annex II to Regulation (EC) No 1528/2007 a new derogation from the rules of origin set out in that Annex. According to the information received from Mauritius the catches of raw tuna remain unusually low even compared to the normal seasonal variations. Given that the abnormal situation since 2008 remains unchanged and because of the problem of piracy in the Indian Ocean a new derogation should be granted with effect from 1 January 2012.

(2)

On 14 August 2008 the Commission adopted Decision 2008/691/EC (4) granting a temporary derogation from the rules of origin laid down in Annex II to Regulation (EC) No 1528/2007 to take account of the special situation of Seychelles with regard to preserved tuna. By Implementing Decision 2011/377/EU extension of that temporary derogation was granted until 31 December 2011. On 17 November 2011 Seychelles requested in accordance with Article 36 of Annex II to Regulation (EC) No 1528/2007 a new derogation from the rules of origin set out in that Annex. According to the information provided by Seychelles the catches of raw tuna remain very low even compared to the normal seasonal variations. Furthermore, the threat of piracy results in a reduced number of fishing days in lucrative but high risk areas. Given that the abnormal situation since 2008 remains unchanged, a new derogation should be granted with effect from 1 January 2012.

(3)

On 18 September 2008 the Commission adopted Decision 2008/751/EC (5) granting a temporary derogation from the rules of origin laid down in Annex II to Regulation (EC) No 1528/2007 to take account of the special situation of Madagascar with regard to preserved tuna and tuna loins. By Implementing Decision 2011/377/EU extension of that temporary derogation was granted until 31 December 2011. On 25 October 2011 Madagascar requested in accordance with Article 36 of Annex II to Regulation (EC) No 1528/2007 a new derogation from the rules of origin set out in that Annex. According to this information sourcing of raw originating tuna remains difficult due to the problem of piracy in the Indian Ocean. Given that the abnormal situation since 2008 remains unchanged, a new derogation should be granted with effect from 1 January 2012.

(4)

Decisions 2008/603/EC, 2008/691/EC and 2008/751/EC applied until 31 December 2011. It is necessary to ensure continuity of importations from the ACP countries to the Union as well as a smooth transition to the Interim Economic Partnership Agreement between the Eastern and Southern Africa States on the one part and the European Community and its Member States on the other part (ESA-EU Interim Economic Partnership Agreement). Decisions 2008/603/EC, 2008/691/EC and 2008/751/EC should therefore be extended from 1 January 2012 to 31 December 2012.

(5)

It would be inappropriate to grant derogations in accordance with Article 36 of Annex II to Regulation (EC) No 1528/2007 which exceed the annual quota granted to the ESA region under the ESA-EU Interim Economic Partnership Agreement. Consequently the quota amounts for 2012 should be set at 3 000 tonnes of preserved tuna and 600 tonnes of tuna loins for Mauritius, 3 000 tonnes of preserved tuna and 600 tonnes of tuna loins for Seychelles and 2 000 tonnes of preserved tuna and 500 tonnes of tuna loins for Madagascar.

(6)

In the interest of clarity, it is appropriate to set out explicitly that the only non-originating materials to be used for the manufacture of preserved tuna and tuna loins of CN code 1604 14 16 should be tuna of HS Headings 0302 or 0303, in order for the preserved tuna and tuna loins to benefit from the derogation.

(7)

Decisions 2008/603/EC, 2008/691/EC and 2008/751/EC should therefore be amended accordingly.

(8)

The measures provided for in this Decision are in accordance with the opinion of the Customs Code Committee,

1.

Article 1 is replaced by the following:

2.

Article 2 is replaced by the following:

3.

Article 6 is replaced by the following:

4.

the Annex is replaced by the text set out in Annex I to this Decision.

1.

Article 1 is replaced by the following:

2.

Article 2 is replaced by the following:

3.

Article 6 is replaced by the following:

4.

the Annex is replaced by the text set out in Annex II to this Decision.

1.

Article 1 is replaced by the following:

2.

Article 2 is replaced by the following:

3.

Article 6 is replaced by the following:

4.

the Annex is replaced by the text set out in Annex III to this Decision.

(1)

In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Directive 91/414/EEC shall continue to apply to active substances for which a decision has been adopted in accordance with Article 6(3) of Directive 91/414/EEC before 14 June 2011.

(2)

In accordance with Article 6(2) of Directive 91/414/EEC, in March 2006 the United Kingdom received an application from Nissan Chemical Europe SARL for the inclusion of the active substance amisulbrom in Annex I to Directive 91/414/EEC. Commission Decision 2007/669/EC (3) confirmed that the dossier was complete and could be considered as satisfying, in principle, the data and information requirements of Annex II and Annex III to that Directive.

(3)

In accordance with Article 6(2) of Directive 91/414/EEC, in February 2007 Ireland received an application from DuPont International Operations SARL for the inclusion of the active substance chlorantraniliprole in Annex I to Directive 91/414/EEC. Commission Decision 2007/560/EC (4) confirmed that the dossier was complete and could be considered as satisfying, in principle, the data and information requirements of Annex II and Annex III to that Directive.

(4)

In accordance with Article 6(2) of Directive 91/414/EEC, in August 2005 the United Kingdom received an application from Dow Agrosciences for the inclusion of the active substance meptyldinocap in Annex I to Directive 91/414/EEC. Commission Decision 2006/589/EC (5) confirmed that the dossier was complete and could be considered as satisfying, in principle, the data and information requirements of Annex II and Annex III to that Directive.

(5)

In accordance with Article 6(2) of Directive 91/414/EEC, in March 2004 the United Kingdom received an application from Syngenta Ltd for the inclusion of the active substance pinoxaden in Annex I to Directive 91/414/EEC. Commission Decision 2005/459/EC (6) confirmed that the dossier was complete and could be considered as satisfying, in principle, the data and information requirements of Annex II and Annex III to that Directive.

(6)

In accordance with Article 6(2) of Directive 91/414/EEC, in January 2003 the Netherlands received an application from Enhold BV for the inclusion of the active substance silver thiosulphate in Annex I to Directive 91/414/EEC. Commission Decision 2003/850/EC (7) confirmed that the dossier was complete and could be considered as satisfying, in principle, the data and information requirements of Annex II and Annex III to that Directive.

(7)

In accordance with Article 6(2) of Directive 91/414/EEC, in November 2005 Austria received an application from Bayer CropScience AG for the inclusion of the active substance tembotrione in Annex I to Directive 91/414/EEC. Commission Decision 2006/586/EC (8) confirmed that the dossier was complete and could be considered as satisfying, in principle, the data and information requirements of Annex II and Annex III to that Directive.

(8)

Confirmation of the completeness of the dossiers was necessary in order to allow them to be examined in detail and to allow Member States the possibility of granting provisional authorisations, for periods of up to three years, for plant protection products containing the active substances concerned, while complying with the conditions laid down in Article 8(1) of Directive 91/414/EEC and, in particular, the conditions relating to the detailed assessment of the active substances and the plant protection products in the light of the requirements laid down by that Directive.

(9)

For these active substances, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicants. The rapporteur Member States submitted the respective draft assessment reports to the Commission on 15 July 2008 (amisulbrom), on 11 February 2009 (chlorantraniliprole), on 25 October 2006 (meptyldinocap), on 30 November 2005 (pinoxaden), on 9 November 2005 (silver thiosulphate) and on 2 February 2007 (tembotrione).

(10)

Following submission of the draft assessment reports by the rapporteur Member States, it has been found to be necessary to request further information from the applicants and to have the rapporteur Member States examine that information and submit their assessment. Therefore, the examination of the dossiers is still ongoing and it will not be possible to complete the evaluation within the time-frame provided for in Directive 91/414/EEC, read in conjunction with Commission Decisions 2010/353/EU (9) (amisulbrom, chlorantraniliprole, meptyldinocap and pinoxaden) and 2010/149/EU (10) (silver thiosulphate and tembotrione).

(11)

As the evaluation so far has not identified any reason for immediate concern, Member States should be given the possibility of prolonging provisional authorisations granted for plant protection products containing the active substances concerned for a period of 24 months in accordance with the provisions of Article 8 of Directive 91/414/EEC so as to enable the examination of the dossiers to continue. It is expected that the evaluation and decision-making process with respect to a decision on a possible approval in accordance with Article 13(2) of Regulation (EC) No 1107/2009 for amisulbrom, chlorantraniliprole, meptyldinocap, pinoxaden, silver thiosulphate and tembotrione will have been completed within 24 months.

(12)

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