(1)

On 12 June 2002, the Council authorised the Commission to open negotiations to conclude Economic Partnership Agreements with ACP countries.

(2)

Negotiations for an Interim Partnership Agreement (hereinafter referred to as the ‘interim EPA’) were concluded on 23 November 2007 with Papua New Guinea and the Republic of the Fiji Islands.

(3)

The interim EPA has not yet been concluded. Following the entry into force of the Treaty of Lisbon, the procedure to be followed to that end is laid down in Article 218 of the Treaty on the Functioning of the European Union.

(4)

The interim EPA should be concluded on behalf of the European Union,

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of the enzyme preparation 6-phytase (EC 3.1.3.26) produced by Aspergillus oryzae DSM 14223. That application was accompanied by the particulars and documents required pursuant to Article 7(3) of Regulation (EC) No 1831/2003.

(3)

The application concerns the authorisation of 6-phytase (EC 3.1.3.26) produced by Aspergillus oryzae DSM 14223 as a feed additive for salmonids, to be classified in the additive category ‘zootechnical additives’.

(4)

Its use was also provisionally authorised for salmonids by Commission Regulation (EC) No 521/2005 (2).

(5)

New data were submitted in support of the application for the authorisation of 6-phytase (EC 3.1.3.26) produced by Aspergillus oryzae DSM 14223 for salmonids. The European Food Safety Authority (‘the Authority’) concluded in its opinion of 10 November 2010 (3) that, under the proposed conditions of use, 6-phytase (EC 3.1.3.26) produced by Aspergillus oryzae DSM 14223 does not have an adverse effect on animal health, human health or the environment, and that its use can improve the phosphorus utilisation. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the European Union Reference Laboratory for Feed Additives set up by Regulation (EC) No 1831/2003.

(6)

The assessment of 6-phytase (EC 3.1.3.26) produced by Aspergillus oryzae DSM 14223 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this preparation should be authorised as specified in the Annex to this Regulation.

(7)

In the interest of clarity, the entry on 6-phytase (EC 3.1.3.26) produced by Aspergillus oryzae DSM 14223 in Regulation (EC) No 521/2005 should be deleted.

(8)

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

(1)

The world market prices for sugar have been at a constant high level since the beginning of the 2010/2011 marketing year. Forecasts of world market prices based on the New York's sugar futures exchange market for the terms of March, May and July 2011 further indicate a constant high world market price.

(2)

The cumulated negative difference between availability and utilisation of sugar and isoglucose over the last two marketing years is estimated at 1,0 million tonnes, and would result in the lowest level of ending stocks in the EU since the implementation of the 2006 reform of the sugar sector. Any further shortfall of imports threatens to seriously disrupt the availability of supply on the Union sugar market and to further deteriorate in the absence of measures for the sector.

(3)

Exports from African, Caribbean and Pacific (ACP) countries and Least Developed Countries (LDCs) to the European Union are not expected to increase in the short run.

(4)

On the other hand, a good harvest in some parts of the Union has led to the production of sugar in excess of the quota set out in Article 56 of Regulation (EC) No 1234/2007. Part of this sugar should be made available to the sugar market of the Union in order to partially satisfy demand and to avoid excessive price increases. The available quantity of sugar in excess of the quota is estimated at 0,5 million tonnes. This estimate takes into account contractual commitments of sugar producers in respect of certain industrial uses provided for in Article 62 of Regulation (EC) No 1234/2007, and the quantities for which export licences have already been issued.

(5)

Article 64(2) of Regulation (EC) No 1234/2007 empowers the Commission to fix the surplus levy on sugar and isoglucose produced in excess of the quota at a sufficiently high level in order to avoid the accumulation of surplus quantities. Article 3(1) of Commission Regulation (EC) No 967/2006 of 29 June 2006 laying down detailed rules for the application of Council Regulation (EC) No 318/2006 as regards sugar production in excess of the quota (2) has fixed that levy at EUR 500 per tonne.

(6)

The extraordinarily low supply of sugar on the internal market in the 2010/2011 marketing year may allow the Commission to exceptionally fix the surplus levy at zero for a limited quantity of sugar produced in excess of the quota, without any risk of accumulation of quantities.

(7)

As Regulation (EC) No 1234/2007 fixes quotas for both sugar and isoglucose, a similar measure should apply for an appropriate quantity of isoglucose produced in excess of the quota because the latter product is, to some extent, a commercial substitute for sugar. In order to preserve the balance between the two sweeteners, the appropriate quantity of out of quota isoglucose to be released on the internal market should be established on the basis of the relation of the quotas for each of the two products fixed in Annex VI to Regulation (EC) No 1234/2007.

(8)

Sugar and isoglucose producers should apply to the competent authorities of the Member States for certificates allowing them to sell certain quantities, produced above the quota limit, on the Union market.

(9)

Fixing upper limits of the quantities for which each producer can apply in one application period and restricting the certificates to products of the applicant's own available production, should prevent speculative actions within the system created by this Regulation.

(10)

Applications should only be possible until the end of June and should only be valid for a short period of time. This should encourage a rapid availability of the quantities on the Union market.

(11)

With their application, sugar producers should commit themselves to pay the minimum price for sugar beet used to produce the quantity of sugar for which they apply.

(12)

The competent authorities of the Member States should notify the Commission of the applications received.

(13)

The Commission should ensure that certificates are granted only within the quantitative limits fixed in this Regulation. Therefore, if necessary, the Commission should be able to fix an allocation coefficient applicable to the applications received.

(14)

Member States should immediately inform the applicants whether their application was fully or partially granted.

(15)

Account taken that the release on the Union market of quantities in excess of the certificates delivered is subject the surplus levy set out in Article 64(2) of Regulation (EC) No 1234/2007, it is appropriate to provide that any applicant not fulfilling his commitment to release on the Union market the quantity covered by a certificate delivered to him, should also pay an amount of EUR 500 per tonne, for reasons of consistency, and to prevent abuse of the exceptional release of out-of-quota sugar and isoglucose on the Union market during marketing year 2010/2011.

(16)

The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for the Common Organisation of Agricultural Markets,

(a)

fix an allocation coefficient, which the Member States shall apply to the quantities covered by each notified certificate application;

(b)

reject applications not yet notified;

(c)

close the period for submitting the applications.

(1)

Commission Regulations (EC) No 451/2000 (2) and (EC) No 1490/2002 (3) lay down the detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list included oryzalin.

(2)

In accordance with Article 11e of Regulation (EC) No 1490/2002 the notifier withdrew its support of the inclusion of that active substance in Annex I to Directive 91/414/EEC within 2 months from receipt of the draft assessment report. Consequently, Commission Decision 2008/934/EC of 5 December 2008 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances (4) was adopted on the non-inclusion of oryzalin.

(3)

Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier (hereinafter ‘the applicant’) submitted a new application requesting the accelerated procedure to be applied, as provided for in Articles 14 to 19 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (5).

(4)

The application was submitted to France, which had been designated rapporteur Member State by Regulation (EC) No 1490/2002. The time period for the accelerated procedure was respected. The specification of the active substance and the supported uses are the same as were the subject of Decision 2008/934/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.

(5)

France evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 17 August 2009. The Authority communicated the additional report to the other Member States and the applicant for comments and forwarded the comments it had received to the Commission. In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on oryzalin to the Commission on 6 August 2010 (6). The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 28 January 2011 in the format of the Commission review report for oryzalin.

(6)

It has appeared from the various examinations made that plant protection products containing oryzalin may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which have been examined and detailed in the Commission review report. It is therefore appropriate to include oryzalin in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.

(7)

Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore, it is necessary that the specification of the technical material, as commercially manufactured, be confirmed by appropriate analytical data, including information on the relevance of the impurities, which for confidentiality reasons are referred to as impurities 2, 6, 7, 9, 10, 11, 12. The relevance of the test material used in the toxicity dossiers should be confirmed in view of the specification of the technical material and information confirming the risk assessment for aquatic organisms should be requested. Provided that oryzalin becomes classified under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (7) as ‘suspected of causing cancer’, the Member States concerned shall request the submission of further information confirming the relevance of the metabolites OR13 (8) and OR15 (9), and the corresponding groundwater risk assessment.

(8)

A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.

(9)

Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of 6 months after inclusion to review existing authorisations of plant protection products containing oryzalin to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

(10)

The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (10) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I.

(11)

It is therefore appropriate to amend Directive 91/414/EEC accordingly.

(12)

Decision 2008/934/EC provides for the non-inclusion of oryzalin and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning oryzalin in the Annex to that Decision.

(13)

It is therefore appropriate to amend Decision 2008/934/EC accordingly.

(14)

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

(1)

Commission Regulations (EC) No 1112/2002 (2) and (EC) No 2229/2004 (3) lay down the detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list included indolylbutyric acid.

(2)

In accordance with Article 24e of Regulation (EC) No 2229/2004 the notifier withdrew its support of the inclusion of that active substance in Annex I to Directive 91/414/EEC within 2 months from receipt of the draft assessment report. Consequently, Commission Decision 2008/941/EC of 8 December 2008 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances (4) was adopted on the non-inclusion of indolylbutyric acid.

(3)

Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier (hereinafter ‘the applicant’) submitted a new application requesting the application of the accelerated procedure provided for in Articles 14 to 19 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (5).

(4)

The application was submitted to France, which had been designated rapporteur Member State by Regulation (EC) No 2229/2004. The time period for the accelerated procedure was respected. The specification of the active substance and the supported uses are the same as were the subject of Decision 2008/941/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.

(5)

France evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 26 January 2010. The Authority communicated the additional report to the other Member States and the applicant for comments and forwarded the comments it had received to the Commission. In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on indolylbutyric acid to the Commission on 3 September 2010 (6). The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 28 January 2011 in the format of the Commission review report for indolylbutyric acid.

(6)

It has appeared from the various examinations made that plant protection products containing indolylbutyric acid may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which have been examined and detailed in the Commission review report. It is therefore appropriate to include indolylbutyric acid in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.

(7)

Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore, it is appropriate to require that the applicant submit further information confirming: the absence of clastogenicity potential of indolylbutyric acid, the vapour pressure of indolylbutyric acid and, consequently, an inhalation toxicity study, and the natural background concentration of indolylbutyric acid in the soil.

(8)

A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.

(9)

Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of 6 months after inclusion to review existing authorisations of plant protection products containing indolylbutyric acid to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

(10)

The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (7) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I.

(11)

It is therefore appropriate to amend Directive 91/414/EEC accordingly.

(12)

Decision 2008/941/EC provides for the non-inclusion of indolylbutyric acid and the withdrawal of authorisation of plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning indolylbutyric acid in the Annex to that Decision.

(13)

It is therefore appropriate to amend Decision 2008/941/EC accordingly.

(14)

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

(1)

The ACP-EU Partnership Agreement entered into force on 1 July 2008 in accordance with Article 93(3) thereof. The amended ACP-EU Partnership Agreement has been provisionally applied since 31 October 2010.

(2)

Equatorial Guinea, which signed the ACP-EU Partnership Agreement on 25 June 2005, deposited an instrument of ratification with a reservation — an instrument that was rejected by the Union and its Member States in a letter of 19 December 2008. As a result, in accordance with Article 93(4) of the amended ACP-EU Partnership Agreement, the ratification is not valid.

(3)

Article 94 of the amended ACP-EU Partnership Agreement stipulates that any request for accession by a State is to be presented to, and approved by, the Council of Ministers.

(4)

In May 2010, Equatorial Guinea presented a request for accession in accordance with Article 94 of the ACP-EU Partnership Agreement and a request for observer status, enabling it to participate in the joint institutions set up by the ACP-EU Partnership Agreement, until the accession procedure was completed.

(5)

The observer status would be valid until 30 April 2011. Equatorial Guinea should deposit the Act of Accession with the Depositaries of the amended ACP-EU Partnership Agreement, namely, the Secretariat General of the Council of the European Union and the Secretariat of the ACP States, no later than that date.

(6)

In accordance with Article 15(4) of the ACP-EU Partnership Agreement, the Council of Ministers agreed in Ouagadougou on 21 June 2010 to give a mandate to the Committee of Ambassadors to take a decision on its behalf,