title: Commission Implementing Regulation (EU) No 1223/2012 of 18 December 2012 laying down detailed rules for the application of an import tariff quota for live bovine animals of a weight exceeding 160 kg and originating in Switzerland provided for in the Agreement between the European Community and the Swiss Confederation on trade in agricultural products

text:
               19.12.2012

               EN

               Official Journal of the European Union

               L 349/39

         COMMISSION IMPLEMENTING REGULATION (EU) No 1223/2012
   of 18 December 2012
   laying down detailed rules for the application of an import tariff quota for live bovine animals of a weight exceeding 160 kg and originating in Switzerland provided for in the Agreement between the European Community and the Swiss Confederation on trade in agricultural products
   (codification)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1), and in particular Article 144(1) in conjunction with Article 4 thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 2172/2005 of 23 December 2005 laying down detailed rules for the application of an import tariff quota for live bovine animals of a weight exceeding 160 kg and originating in Switzerland provided for in the Agreement between the European Community and the Swiss Confederation on trade in agricultural products (2) has been substantially amended several times (3). In the interests of clarity and rationality the said Regulation should be codified.

               (2)

               The Agreement between the European Community and the Swiss Confederation on trade in agricultural products (4) (‘the Agreement’) provides for the opening of a duty-free Union tariff quota for the import of 4 600 live bovine animals weighing more than 160 kg and originating in Switzerland. Detailed rules should be adopted for the opening and administration of this tariff quota on an annual basis.

               (3)

               For the allocation of that tariff quota and given the products concerned it is appropriate to apply the method of simultaneous examination referred to in Article 144(2)(b) of Regulation (EC) No 1234/2007.

               (4)

               To be eligible for the benefit of that tariff quota, the live animals should originate in Switzerland in conformity with the rules referred to in Article 4 of the Agreement.

               (5)

               With a view to preventing speculation, the quantities available within the tariff quota should be made accessible to operators able to show that they are genuinely engaged in trade of a significant scale with third countries. In consideration of this and in order to ensure efficient management, the traders concerned should be required to have imported a minimum of 50 animals during the year previous to the annual quota period in question, given that a consignment of 50 animals may be considered to be a normal load. Experience has shown that the purchase of a single consignment is a minimum requirement for a transaction to be considered real and viable.

               (6)

               A security should be fixed for import rights, licences should not be transferable and import licences should be issued to traders solely for the quantities for which they have been allocated import rights.

               (7)

               To provide a more equal access to the tariff quota while ensuring a commercially viable number of animals per application, maximum and minimum limits should be fixed for the number of animals covered by each application.

               (8)

               It should be established that import rights are to be allocated after a reflection period and where necessary with a fixed allocation coefficient applied.

               (9)

               Pursuant to Article 130 of Regulation (EC) No 1234/2007, the arrangements have to be managed using import licences. To this end, rules should be laid down on the submission of applications and the information to be given on applications and licences, where necessary in addition to or by way of derogation from certain provisions of Commission Regulation (EC) No 1301/2006 of 31 August 2006 laying down common rules for the administration of import tariff quotas for agricultural products managed by a system of import licences (5), Commission Regulation (EC) No 376/2008 of 23 April 2008 laying down common detailed rules for the application of the system of import and export licences and advance fixing certificates for agricultural products (6) and Commission Regulation (EC) No 382/2008 of 21 April 2008 on rules of application for import and export licences in the beef and veal sector (7).

               (10)

               To oblige operators to apply for import licences for all import rights allocated, it should be established that the application should constitute, with regard to the import rights security, a primary requirement within the meaning of Commission Implementing Regulation (EU) No 282/2012 of 28 March 2012 laying down common detailed rules for the application of the system of securities for agricultural products (8).

               (11)

               Experience shows that a proper management of the tariff quota also requires that the titular holder of the licence is a genuine importer. Therefore, such importer should actively participate in the purchase, transport and import of the animals concerned. Presentation of proof of those activities should thus also be a primary requirement with regard to the licence security.

               (12)

               With a view to ensuring a strict statistical control of the animals imported under this tariff quota, the tolerance referred to in Article 7(4) of Regulation (EC) No 376/2008 should not apply.

               (13)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   1.   A duty-free Union import tariff quota is opened every year for periods from 1 January to 31 December for the import of 4 600 live bovine animals originating in Switzerland weighing more than 160 kg, falling within CN codes 0102 29 41, 0102 29 49, 0102 29 51, 0102 29 59, 0102 29 61, 0102 29 69, 0102 29 91, 0102 29 99, ex 0102 39 10 of a weight exceeding 160 kg or ex 0102 90 91 of a weight exceeding 160 kg.
   That tariff quota shall have the order number 09.4203.
   2.   The rules of origin applicable to the products referred to in paragraph 1 shall be those provided for in Article 4 of the Agreement between the European Community and the Swiss Confederation on trade in agricultural products.
   Article 2
   1.   For the purposes of Article 5 of Regulation (EC) No 1301/2006, engagement in trade with third countries as referred to in that Article shall mean that applicants have imported at least 50 animals covered by CN code 0102.
   Member States may accept as proof of trade with third countries copies of the documents referred to in the second paragraph of Article 5 of Regulation (EC) No 1301/2006, duly certified by the competent authority.
   2.   A company formed by the merger of companies each having reference imports complying with the minimum quantity referred to in paragraph 1 may use those reference imports as a basis for its application.
   Article 3
   1.   Applications for import rights must cover at least 50 animals and may not cover more than 5 % of the quantity available.
   2.   Applications for import rights shall be lodged at the latest before 13.00, Brussels time, on 1 December preceding the annual quota period in question.
   3.   After verification of the documents presented, Member States shall notify the Commission, by the tenth working day following the end of the period for the submission of applications at the latest, of the total quantities applied for.
   Notwithstanding Article 6(3) of Regulation (EC) No 1301/2006, Article 11 of that Regulation shall apply.
   Article 4
   1.   Import rights shall be awarded as from the seventh and no later than the sixteenth working day following the end of the period for the notifications referred to in the first subparagraph of Article 3(3).
   2.   Where the application of the allocation coefficient referred to in Article 7(2) of Regulation (EC) No 1301/2006 gives a figure of less than 50 head per application, the quantity available shall be awarded by the Member States concerned by drawing lots for import rights covering 50 head each. Where the remainder is less than 50 head, a single import right shall be awarded for that quantity.
   3.   Where the application of paragraph 2 results in fewer import rights to be allocated than had been applied for, the security lodged in accordance with Article 5(1) shall be released proportionally without delay.
   Article 5
   1.   The security relating to the import rights shall be EUR 3 per head. It must be lodged with the competent authority together with the application for import rights.
   2.   Import licence applications must be made for the quantity allocated. This obligation shall constitute a primary requirement within the meaning of Article 19(2) of Implementing Regulation (EU) No 282/2012.
   3.   Where the application of the allocation coefficient referred to in Article 4(2) causes less import rights to be allocated than had been applied for, the security lodged shall be released proportionally without delay.
   Article 6
   1.   The quantities awarded shall be imported subject to presentation of one or more import licences.
   2.   Licence applications may be lodged solely in the Member State where the applicant has applied for and obtained import rights under the tariff quota.
   Each issuing of import licences shall result in a corresponding reduction of the import rights obtained and the security lodged in accordance with Article 5(1) shall be released proportionally without delay.
   3.   Import licences shall be issued on application by and in the name of the operator who has obtained the import rights.
   4.   Licence applications and licences shall show the following:

               (a)

               in box 8, the country of origin and the mention ‘yes’ is marked by a cross;

               (b)

               in box 16, one or several of the following CN codes:
               0102 29 41, 0102 29 49, 0102 29 51, 0102 29 59, 0102 29 61, 0102 29 69, 0102 29 91, 0102 29 99, ex 0102 39 10 of a weight exceeding 160 kg or ex 0102 90 91 of a weight exceeding 160 kg;

               (c)

               in box 20, the order number of the tariff quota (09.4203) and at least one of the entries listed in Annex I.

         Licences shall carry with them an obligation to import from Switzerland.
   Article 7
   1.   By way of derogation from Article 8(1) of Regulation (EC) No 376/2008, import licences issued pursuant to this Regulation shall not be transferable.
   2.   The grant of the import licence shall be conditional on the lodging of a security of EUR 20 per head which shall be composed of:

               (a)

               the security of EUR 3 referred to in Article 5(1); and

               (b)

               an amount of EUR 17 which the applicant shall lodge together with the licence application.

         3.   Pursuant to Article 48(1) of Regulation (EC) No 376/2008, the full Common Customs Tariff duty applicable on the date of acceptance of the customs declaration for free circulation shall be collected in respect of all quantities imported in excess of those shown on the import licence.
   4.   Notwithstanding the provisions of Section 4 of Chapter III of Regulation (EC) No 376/2008, the security shall not be released until proof has been produced that the titular holder of the licence has been commercially and logistically responsible for the purchase, transport and clearance for free circulation of the animals concerned. Such proof shall at least consist of:

               (a)

               the original commercial invoice or authenticated copy made out in the name of the titular holder by the seller or his representative, both established in Switzerland, and proof of payment by the titular holder or the opening by the titular holder of an irrevocable documentary credit in favour of the seller;

               (b)

               the transport document, drawn up in the name of the titular holder, for the animals concerned;

               (c)

               proof that the goods have been declared for release for free circulation with the indication of the name and address of the titular holder as consignee.

         Article 8
   Regulations (EC) No 1301/2006, (EC) No 376/2008 and (EC) No 382/2008 shall apply, subject to this Regulation.
   Article 9
   1.   By way of derogation from the second subparagraph of Article 11(1) of Regulation (EC) No 1301/2006, Member States shall notify to the Commission:

               (a)

               no later than 28 February following the end of each import tariff quota period, the quantities of products, including nil returns, for which import licences were issued in the previous import tariff quota period;

               (b)

               no later than 30 April following the end of each import tariff quota period, the quantities of products, including nil returns, covered by unused or partly used import licences and corresponding to the difference between the quantities entered on the back of the import licences and the quantities for which they were issued.

         2.   No later than 30 April following the end of each import tariff quota period, Member States shall forward to the Commission details of the quantities of products put into free circulation in accordance with Article 4 of Regulation (EC) No 1301/2006.
   3.   For the notifications referred to in paragraphs 1 and 2, the quantities shall be expressed in heads and per product category as indicated in Annex V to Regulation (EC) No 382/2008.
   Article 10
   Regulation (EC) No 2172/2005 is repealed.
   References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex III.
   Article 11
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 18 December 2012.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 299, 16.11.2007, p. 1.

      (2)  OJ L 346, 29.12.2005, p. 10.

      (3)  See Annex II.

      (4)  OJ L 114, 30.4.2002, p. 132.

      (5)  OJ L 238, 1.9.2006, p. 13.

      (6)  OJ L 114, 26.4.2008, p. 3.

      (7)  OJ L 115, 29.4.2008, p. 10.

      (8)  OJ L 92, 30.3.2012, p. 4.

      ANNEX I

         Entries referred to in Article 6(4)(c)

                  —

                  :

                  in Bulgarian

                  :

                  Регламент за изпълнение (ЕC) № 1223/2012

                  —

                  :

                  in Spanish

                  :

                  Reglamento de Ejecución (UE) no 1223/2012

                  —

                  :

                  in Czech

                  :

                  Prováděcí nařízení (EU) č. 1223/2012

                  —

                  :

                  in Danish

                  :

                  Gennemførelsesforordning (EU) nr. 1223/2012

                  —

                  :

                  in German

                  :

                  Durchführungsverordnung (EU) Nr. 1223/2012

                  —

                  :

                  in Estonian

                  :

                  Rakendusmäärus (EL) nr 1223/2012

                  —

                  :

                  in Greek

                  :

                  Εκτελεστικός κανονισμός (ΕΕ) αριθ. 1223/2012

                  —

                  :

                  in English

                  :

                  Implementing Regulation (EU) No 1223/2012

                  —

                  :

                  in French

                  :

                  Règlement d’exécution (UE) no 1223/2012

                  —

                  :

                  in Italian

                  :

                  Regolamento di esecuzione (UE) n. 1223/2012

                  —

                  :

                  in Latvian

                  :

                  Īstenošanas regula (ES) Nr. 1223/2012

                  —

                  :

                  in Lithuanian

                  :

                  Įgyvendinimo reglamentas (ES) Nr. 1223/2012

                  —

                  :

                  in Hungarian

                  :

                  1223/2012/EU végrehajtási rendelet

                  —

                  :

                  in Maltese

                  :

                  Regolament ta’ Implimentazzjoni (UE) Nru 1223/2012

                  —

                  :

                  in Dutch

                  :

                  Uitvoeringsverordening (EU) nr. 1223/2012

                  —

                  :

                  in Polish

                  :

                  Rozporządzenie wykonawcze (UE) nr 1223/2012

                  —

                  :

                  in Portuguese

                  :

                  Regulamento de Execução (UE) n.o 1223/2012

                  —

                  :

                  in Romanian

                  :

                  Regulamentul de punere în aplicare (UE) nr. 1223/2012

                  —

                  :

                  in Slovak

                  :

                  Vykonávacie nariadenie (EÚ) č. 1223/2012

                  —

                  :

                  in Slovenian

                  :

                  Izvedbena uredba (EU) št. 1223/2012

                  —

                  :

                  in Finnish

                  :

                  Täytäntöönpanoasetus (EU) N:o 1223/2012

                  —

                  :

                  in Swedish

                  :

                  Genomförandeförordning (EU) nr 1223/2012

      ANNEX II

         Repealed Regulation with list of its successive amendments

                  Commission Regulation (EC) No 2172/2005
                  (OJ L 346, 29.12.2005, p. 10).

                  Commission Regulation (EC) No 1869/2006
                  (OJ L 358, 16.12.2006, p. 49).

                  Commission Regulation (EC) No 1965/2006
                  (OJ L 408, 30.12.2006, p. 26).

                  Article 8 and Annex IX only

                  Commission Regulation (EC) No 749/2008
                  (OJ L 202, 31.7.2008, p. 37).

                  Article 3 only

                  Commission Regulation (EC) No 1267/2008
                  (OJ L 338, 17.12.2008, p. 37).

      ANNEX III

         Correlation Table

                  Regulation (EC) No 2172/2005

                  This Regulation

                  Article 1

                  Article 1

                  Article 2(1)

                  Article 2(1)

                  Article 2(4)

                  Article 2(2)

                  Article 3(2)

                  Article 3(1)

                  Article 3(3), first subparagraph

                  Article 3(2)

                  Article 3(3), second subparagraph

                  —

                  Article 3(5)

                  Article 3(3)

                  Articles 4, 5 and 6

                  Articles 4, 5 and 6

                  Article 7(1)

                  Article 7(1)

                  Article 7(3)

                  Article 7(2)

                  Article 7(5)

                  Article 7(3)

                  Article 7(6)

                  Article 7(4)

                  Article 8

                  Article 8

                  Article 8a(1)

                  Article 9(1)

                  Article 8a(2), first and second subparagraphs

                  Article 9(2)

                  Article 8a(3)

                  Article 9(3)

                  —

                  Article 10

                  Article 9

                  Article 11

                  Annex II

                  Annex I

                  —

                  Annex II

                  —

                  Annex III


title: Commission Implementing Regulation (EU) No 1143/2011 of 10 November 2011 approving the active substance prochloraz, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 and Commission Decision 2008/934/EC Text with EEA relevance

text:
               11.11.2011

               EN

               Official Journal of the European Union

               L 293/26

         COMMISSION IMPLEMENTING REGULATION (EU) No 1143/2011
   of 10 November 2011
   approving the active substance prochloraz, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 and Commission Decision 2008/934/EC
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Articles 13(2) and 78(2) thereof,
   Whereas:

               (1)

               In accordance with Article 80(1)(c) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply to active substances for which completeness has been established in accordance with Article 16 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 (3), with respect to the procedure and the conditions for approval. Prochloraz is an active substance for which completeness has been established in accordance with that Regulation.

               (2)

               Commission Regulations (EC) No 451/2000 (4) and (EC) No 1490/2002 (5) lay down the detailed rules for the implementation of the second and third stages 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 prochloraz.

               (3)

               In accordance with Article 3(2) of Commission Regulation (EC) No 1095/2007 of 20 September 2007 amending Regulation (EC) No 1490/2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC and Regulation (EC) No 2229/2004 laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (6) the notifier withdrew its support of the inclusion of that active substance in Annex I to Directive 91/414/EEC within 2 months from entry into force of that Regulation. 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 (7) was adopted on the non-inclusion of prochloraz.

               (4)

               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 Regulation (EC) No 33/2008.

               (5)

               The application was submitted to Ireland, 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.

               (6)

               Ireland 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 3 August 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 prochloraz to the Commission on 13 July 2011 (8). 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 27 September 2011 in the format of the Commission review report for prochloraz.

               (7)

               It has appeared from the various examinations made that plant protection products containing prochloraz 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 as regards the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve prochloraz in accordance with Regulation (EC) No 1107/2009.

               (8)

               In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions.

               (9)

               Without prejudice to the conclusion that prochloraz should be approved, it is, in particular, appropriate to require further confirmatory information.

               (10)

               A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval.

               (11)

               Without prejudice to the obligations defined by Regulation (EC) No 1107/2009 as a consequence of the approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009, the following should, however, apply. Member States should be allowed a period of 6 months after approval to review authorisations of plant protection products containing prochloraz. Member States should, as appropriate, vary, replace or withdraw existing authorisations. By way of derogation from the above deadline, a longer period should be provided for the submission and assessment of the update of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.

               (12)

               The experience gained from 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 (9) 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 to that Directive or the Regulations approving active substances.

               (13)

               In accordance with Article 13(4) of Regulation (EC) No 1107/2009 the Annex to Commission Implementing Regulation (EU) No 540/2011 (10) should be amended accordingly.

               (14)

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

               (15)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Approval of active substance
   The active substance prochloraz, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
   Article 2
   Re-evaluation of plant protection products
   1.   Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing prochloraz as an active substance by 30 June 2012.
   By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in Part B of the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing prochloraz as either the only active substance or as one of several active substances all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 31 December 2011 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account Part B of the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009. Following that determination Member States shall:

               (a)

               in the case of a product containing prochloraz as the only active substance, where necessary, amend or withdraw the authorisation by 31 December 2015 at the latest; or

               (b)

               in the case of a product containing prochloraz as one of several active substances, where necessary, amend or withdraw the authorisation by 31 December 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or substances, whichever is the latest.

         Article 3
   Amendments to Implementing Regulation (EU) No 540/2011
   The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
   Article 4
   Amendments to Decision 2008/934/EC
   The line concerning prochloraz in the Annex to Decision 2008/934/EC is deleted.
   Article 5
   Entry into force and date of application
   This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   It shall apply from 1 January 2012.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 10 November 2011.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 309, 24.11.2009, p. 1.

      (2)  OJ L 230, 19.8.1991, p. 1.

      (3)  OJ L 15, 18.1.2008, p. 5.

      (4)  OJ L 55, 29.2.2000, p. 25.

      (5)  OJ L 224, 21.8.2002, p. 23.

      (6)  OJ L 246, 21.9.2007, p. 19.

      (7)  OJ L 333, 11.12.2008, p. 11.

      (8)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance prochloraz. EFSA Journal 2011, 9(7):2323 [120 pp.]. doi:10.2903/j.efsa.2011.2323. Available online: www.efsa.europa.eu

      (9)  OJ L 366, 15.12.1992, p. 10.

      (10)  OJ L 153, 11.6.2011, p. 1.

      ANNEX I

                  Common Name, Identification Numbers

                  IUPAC Name

                  Purity (1)

                  Date of approval

                  Expiration of approval

                  Specific provisions

                  Prochloraz
                  CAS No 67747-09-5
                  CIPAC No 407

                     N-propyl-N-[2-(2,4,6-trichlorophenoxy)ethyl]imidazole-1-carboxamide

                  ≥ 970 g/kg
                  Impurities:
                  Sum of dioxins and furans (WHO-PCDD/T TEQ) (2): not more than 0,01 mg/kg

                  1 January 2012

                  31 December 2021

                  PART A
                  Only uses as fungicide may be authorised. In the case of outdoor uses, rates shall not exceed 450 g/ha per application.
                  PART B
                  For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on prochloraz, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 September 2011, shall be taken into account.
                  In this overall assessment Member States:

                              (a)

                              shall pay particular attention to the protection of operators and workers and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;

                              (b)

                              shall pay particular attention to the risk to aquatic organisms, and shall ensure that conditions of authorisation include risk mitigation measures, where appropriate;

                              (c)

                              shall pay particular attention to the long-term risk to mammals and shall ensure that conditions of authorisation include risk mitigation measures, where appropriate.

                        The applicants shall submit confirmatory information as regards:

                              (1)

                              comparison and verification of the test material used in the mammalian toxicity and ecotoxicity dossiers against the specification of the technical material;

                              (2)

                              the environmental risk assessment for the metal complexes of prochloraz;

                              (3)

                              the potential endocrine disrupting properties of prochloraz on birds.

                        The notifier shall submit to the Commission, the Member States and the Authority the information set out in points 1 and 2 by 31 December 2013 and the information set out in point 3 within 2 years after the adoption of the pertinent OECD test guidelines on endocrine disruption.

         (1)  Further details on identity and specification of active substance are provided in the review report.

         (2)  Dioxins (sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs), expressed as World Health Organisation (WHO) toxic equivalent (TEQ) using the WHO-toxic equivalency factors (WHO-TEFs)).

      ANNEX II
      In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

                     ‘20

                     Prochloraz
                     CAS No 67747-09-5
                     CIPAC No 407

                        N-propyl-N-[2-(2,4,6-trichlorophenoxy)ethyl]imidazole-1-carboxamide

                     ≥ 970 g/kg
                     Impurities:
                     Sum of dioxins and furans (WHO-PCDD/T TEQ) (1): not more than 0,01 mg/kg

                     1 January 2012

                     31 December 2021

                     PART A
                     Only uses as fungicide may be authorised. In the case of outdoor uses, rates shall not exceed 450 g/ha per application.
                     PART B
                     For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on prochloraz, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 September 2011, shall be taken into account.
                     In this overall assessment Member States:

                                 (a)

                                 shall pay particular attention to the protection of operators and workers and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;

                                 (b)

                                 shall pay particular attention to the risk to aquatic organisms, and shall ensure that conditions of authorisation include risk mitigation measures, where appropriate;

                                 (c)

                                 shall pay particular attention to the long-term risk to mammals and shall ensure that conditions of authorisation include risk mitigation measures, where appropriate.

                           The applicants shall submit confirmatory information as regards:

                                 (1)

                                 comparison and verification of the test material used in the mammalian toxicity and ecotoxicity dossiers against the specification of the technical material;

                                 (2)

                                 the environmental risk assessment for the metal complexes of prochloraz;

                                 (3)

                                 the potential endocrine disrupting properties of prochloraz on birds.

                           The notifier shall submit to the Commission, the Member States and the Authority the information set out in points 1 and 2 by 31 December 2013 and the information set out in point 3 within 2 years after the adoption of the pertinent OECD test guidelines on endocrine disruption.

         (1)  Dioxins (sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs), expressed as World Health Organisation (WHO) toxic equivalent (TEQ) using the WHO-toxic equivalency factors (WHO-TEFs)).’


title: Commission Implementing Regulation (EU) No 608/2012 of 6 July 2012 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances denathonium benzoate, methyl nonyl ketone and plant oils/spearmint oil  Text with EEA relevance

text:
               7.7.2012

               EN

               Official Journal of the European Union

               L 177/19

         COMMISSION IMPLEMENTING REGULATION (EU) No 608/2012
   of 6 July 2012
   amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances denathonium benzoate, methyl nonyl ketone and plant oils/spearmint oil
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2)(c) thereof,
   Whereas:

               (1)

               The active substances denathonium benzoate, methyl nonyl ketone and plant oils/spearmint oil were included in Annex I to Council Directive 91/414/EEC (2) by Commission Directive 2008/127/EC (3) in accordance with the procedure provided for in Article 24b of Commission Regulation (EC) No 2229/2004 of 3 December 2004 laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (4). Since the replacement of Directive 91/414/EEC by Regulation (EC) No 1107/2009, these substances are deemed to have been approved under that Regulation and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (5).

               (2)

               In accordance with Article 25a of Regulation (EC) No 2229/2004, the European Food Safety Authority, hereinafter ‘the Authority’, presented to the Commission its views on the draft review reports for denathonium benzoate (6), methyl nonyl ketone (7) on 2 December 2011 and for plant oils/spearmint oil (8) on 16 December 2011. The draft review reports and the views 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 1 June 2012 in the format of the Commission review reports for denathonium benzoate, methyl nonyl ketone and plant oils/spearmint oil.

               (3)

               The Authority communicated its views on denathonium benzoate, methyl nonyl ketone and plant oils/spearmint oil to the notifiers, and the Commission invited them to submit comments on the review reports.

               (4)

               It is confirmed that the active substances denathonium benzoate, methyl nonyl ketone and plant oils/spearmint oil are to be deemed to have been approved under Regulation (EC) No 1107/2009.

               (5)

               In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is necessary to amend the conditions of approval of denathonium benzoate, methyl nonyl ketone and plant oils/spearmint oil. It is, in particular, appropriate to require further confirmatory information as regards methyl nonyl ketone. The use of plant oils/spearmint oil should be restricted to postharvest treatment of potatoes.

               (6)

               A reasonable period of time should be allowed before the application of this Regulation in order to allow Member States, notifiers and holders of authorisations for plant protection products to meet the requirements resulting from amendment to the conditions of the approval.

               (7)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   It shall apply from 1 November 2012.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 6 July 2012.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 309, 24.11.2009, p. 1.

      (2)  OJ L 230, 19.8.1991, p. 1.

      (3)  OJ L 344, 20.12.2008, p. 89.

      (4)  OJ L 379, 24.12.2004, p. 13.

      (5)  OJ L 153, 11.6.2011, p. 1.

      (6)  Conclusion on the peer review of the pesticide risk assessment of the active substance denatonium benzoate, EFSA Journal 2012;10(1):2483. Available online: www.efsa.europa.eu/efsajournal.htm

      (7)  Conclusion on the peer review of the pesticide risk assessment of the active substance methyl nonyl ketone, EFSA Journal 2012;10(1):2495. Available online: www.efsa.europa.eu/efsajournal.htm

      (8)  Conclusion on the peer review of the pesticide risk assessment of the active substance plant oils/spearmint oil, EFSA Journal 2012;10(1):2541.Available online: www.efsa.europa.eu/efsajournal.htm

      ANNEX
      Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

                  (1)

                  Row 226 on the active substance denathonium benzoate is replaced by the following

                              Number

                              Common Name, Identification Numbers

                              IUPAC Name

                              Purity (1)

                              Date of approval

                              Expiration of approval

                              Specific provisions

                              ‧226

                              Denathonium benzoate
                              CAS No 3734-33-6
                              CIPAC No 845

                              Benzyldiethyl[[2,6-xylylcarbamoyl]methyl]ammonium benzoate

                              ≥ 975g/kg

                              1 September 2009

                              31 August 2019

                              PART A
                              Only uses as repellent may be authorised.
                              PART B
                              In assessing applications to authorise plant protection products containing denathonium benzoate for uses other than brushing with automatic rolling equipment in forestry, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.
                              For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on denathonium benzoate (SANCO/2607/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.
                              In this overall assessment Member States must pay particular attention to the protection of the operators. Authorised conditions of use must prescribe the application of adequate personal protective equipment.
                              Conditions of use shall include, where appropriate, risk mitigation measures.‧

                  (2)

                  Row 238 on the active substance methyl nonyl ketone is replaced by the following:

                              Number

                              Common Name, Identification Numbers

                              IUPAC Name

                              Purity (2)

                              Date of approval

                              Expiration of approval

                              Specific provisions

                              ‧238

                              Methyl nonyl ketone
                              CAS No 112-12-9
                              CIPAC No 846

                              Undecan-2-one

                              ≥ 975g/kg

                              1 September 2009

                              31 August 2019

                              PART A
                              Only uses as repellent may be authorised.
                              PART B
                              For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on methyl nonyl ketone (SANCO/2619/2008) and in particular Appendices I and II thereof,as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.
                              Conditions of use shall include, where appropriate, risk mitigation measures. Contact with food and feedcrops shall be avoided.
                              The notifier shall submit confirmatory information as regards:

                                          (a)

                                          the specification of the material tested in the mammalian toxicology and ecotoxicology studies;

                                          (b)

                                          the specification with suporting batch data and validated methods of analysis;

                                          (c)

                                          an appropriate assessment of the fate and behaviour of methyl nonyl ketone and potential transformation products in the environment;

                                          (d)

                                          the risk to aquatic and to soil living organisms.

                                    The notifier shall submit to the Commission, the Member States and the Authority the information set out in points (a) and (b) by 30 April 2013 and the information set out in points (c) and (d) by 31 December 2015.‧

                  (3)

                  Row 243 on the active substance plant oils/spearmint oil is replaced by the following:

                              Number

                              Common Name, Identification Numbers

                              IUPAC Name

                              Purity (3)

                              Date of approval

                              Expiration of approval

                              Specific provisions

                              ‧243

                              Plant oils/spear mint oil
                              CAS No 8008-79-5
                              CIPAC No 908

                              Spearmint oil

                              ≥ 550 g/kg as (R)-Carvone

                              1 September 2009

                              31 August 2019

                              PART A
                              Only uses as plant growth regulator for postharvest treatment of potatoes may be authorised.
                              Member States shall ensure that authorisations provide that hot fogging is performed exclusively in professional storage facilities and that the best available techniques are applied to exclude the release into the environment of the product (fogging mist) during storage, transport, waste disposal and application.
                              PART B
                              For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on plant oils/spearmint oil (SANCO/2624/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.
                              Conditions of use shall include, where appropriate, risk mitigation measures.‧

         (1)  Further details on identity and specification of active substance are provided in their review report.

         (2)  Further details on identity and specification of active substance are provided in their review report.

         (3)  Further details on identity and specification of active substance are provided in their review report.


title: Commission Implementing Regulation (EU) No 703/2011 of 20 July 2011 approving the active substance azoxystrobin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011  Text with EEA relevance

text:
               21.7.2011

               EN

               Official Journal of the European Union

               L 190/33

         COMMISSION IMPLEMENTING REGULATION (EU) No 703/2011
   of 20 July 2011
   approving the active substance azoxystrobin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) and Article 78(2) thereof,
   Whereas:

               (1)

               In accordance with Article 80(1)(b) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply to active substances listed in Annex I to Commission Regulation (EC) No 737/2007 of 27 June 2007 on laying down the procedure of the renewal of the inclusion of a first group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances (3), with respect to the procedure and the conditions for approval. Azoxystrobin is listed in Annex I to Regulation (EC) No 737/2007.

               (2)

               The approval of azoxystrobin, as set out in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (4), expires on 31 December 2011. A notification was submitted in accordance with Article 4 of Regulation (EC) No 737/2007 for the renewal of the inclusion of azoxystrobin in Annex I to Directive 91/414/EEC within the time period provided for in that Article.

               (3)

               That notification was found to be admissible by Commission Decision 2008/656/EC of 28 July 2008 on the admissibility of the notifications concerning the renewal of the inclusion in Annex I to Council Directive 91/414/EEC of the active substances azimsulfuron, azoxystrobin, fluroxypyr, imazalil, kresoxim-methyl, prohexadione and spiroxamine, and establishing the list of the notifiers concerned (5).

               (4)

               Within the time period provided for in Article 6 of Regulation (EC) No 737/2007, the notifier submitted the data required in accordance with that Article together with an explanation as regards the relevance of each new study submitted.

               (5)

               The rapporteur Member State prepared an assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (hereinafter ‘the Authority’) and the Commission on 10 June 2009. In addition to the assessment of the active substance, that report includes a list of the studies the rapporteur Member State relied on for its assessment.

               (6)

               The Authority communicated the assessment report to the notifier and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the assessment report available to the public.

               (7)

               At the request of the Commission, the assessment report was peer reviewed by the Member States and the Authority. The Authority presented its conclusion on the peer review of the risk assessment of azoxystrobin (6) to the Commission on 12 March 2010. The assessment 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 17 June 2011 in the format of the Commission review report for azoxystrobin.

               (8)

               It has appeared from the various examinations made that plant protection products containing azoxystrobin may be expected to continue to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular as regards the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve azoxystrobin.

               (9)

               In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions not provided for in the first inclusion in Annex I to Directive 91/414/EEC.

               (10)

               Based on the review report, which points out that for the active substance azoxystrobin notified by the main data submitter the manufacturing impurity toluene is of toxicological concern, a maximum level of 2 g/kg should, however, be set for that impurity in the technical material.

               (11)

               From the new data submitted, it appears that azoxystrobin may cause risks for aquatic organisms. Without prejudice to the conclusion that azoxystrobin should be approved, it is, in particular, appropriate to require further confirmatory information.

               (12)

               A reasonable period should be allowed to elapse before approval in order to permit Member States and interested parties to prepare themselves to meet the new requirements resulting from the approval.

               (13)

               Without prejudice to the obligations provided for by Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009 the following should, however, apply. Member States should be allowed a period of 6 months after approval to review authorisations of plant protection products containing azoxystrobin. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the update of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.

               (14)

               The experience gained from 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 to that Directive or the Regulations approving active substances.

               (15)

               In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Implementing Regulation (EU) No 540/2011 should be amended accordingly.

               (16)

               In the interest of clarity, Commission Directive 2010/55/EU of 20 August 2010 amending Annex I to Council Directive 91/414/EEC to renew the inclusion of azoxystrobin as active substance (8) should be repealed.

               (17)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Approval of active substance
   The active substance azoxystrobin, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
   Article 2
   Re-evaluation of plant protection products
   1.   Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing azoxystrobin as an active substance by 30 June 2012.
   By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in Part B of the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Article 13(1) to (4) of Directive 91/414/EEC and Article 62 of Regulation (EC) No 1107/2009.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing azoxystrobin as either the only active substance or as one of several active substances all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 31 December 2011 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account Part B of the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product still satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.
   Following that determination Member States shall:

               (a)

               in the case of a product containing azoxystrobin as the only active substance, where necessary, amend or withdraw the authorisation by 31 December 2015 at the latest; or

               (b)

               in the case of a product containing azoxystrobin as one of several active substances, where necessary, amend or withdraw the authorisation by 31 December 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or substances, whichever is the latest.

         Article 3
   Amendments to Implementing Regulation (EU) No 540/2011
   The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
   Article 4
   Repeal
   Directive 2010/55/EU is repealed.
   Article 5
   Entry into force and date of application
   This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   It shall apply from 1 January 2012.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 20 July 2011.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 309, 24.11.2009, p. 1.

      (2)  OJ L 230, 19.8.1991, p. 1.

      (3)  OJ L 169, 29.6.2007, p. 10.

      (4)  OJ L 153, 11.6.2011, p. 1.

      (5)  OJ L 214, 9.8.2008, p. 70.

      (6)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance azoxystrobin. EFSA Journal 2010; 8(4):15421542. [110 pp.]. doi:10.2903/j.efsa.2010.1542. Available online: www.efsa.europa.eu

      (7)  OJ L 366, 15.12.1992, p. 10.

      (8)  OJ L 220, 21.8.2010, p. 67.

      ANNEX I

                  Common Name, Identification Numbers

                  IUPAC Name

                  Purity (1)

                  Date of approval

                  Expiration of approval

                  Specific provisions

                  Azoxystrobin
                  CAS No 131860-33-8
                  CIPAC No 571

                  methyl (E)-2-{2[6-(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl}-3-methoxyacrylate

                  ≥ 930 g/kg
                  Toluene maximum content 2 g/kg
                  Z-isomer maximum content 25 g/kg

                  1 January 2012

                  31 December 2021

                  PART A
                  Only uses as fungicide may be authorised.
                  PART B
                  For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on azoxystrobin and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to:

                              (1)

                              the fact that the specification of the technical material as commercially manufactured must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material;

                              (2)

                              the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

                              (3)

                              the protection of aquatic organisms.

                        The Member States must ensure that the conditions of authorisation include risk mitigation measures, where appropriate.
                  The Member States concerned shall request the submission of confirmatory information as regards the risk assessment on groundwater and aquatic organisms.
                  The notifier shall submit to the Member States, the Commission and the Authority such information by 31 December 2013.

         (1)  Further details on identity and specification of active substance are provided in the review report.

      ANNEX II
      The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

                  (1)

                  in Part A, the entry relating to azoxystrobin is deleted;

                  (2)

                  in Part B, the following entry is added:

                              Common Name, Identification Numbers

                              IUPAC Name

                              Purity (1)

                              Date of approval

                              Expiration of approval

                              Specific provisions

                              ‘4

                              Azoxystrobin
                              CAS No 131860-33-8
                              CIPAC No 571

                              methyl (E)-2-{2[6-(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl}-3-methoxyacrylate

                              ≥ 930 g/kg
                              Toluene maximum content 2 g/kg
                              Z-isomer maximum content 25 g/kg

                              1 January 2012

                              31 December 2021

                              PART A
                              Only uses as fungicide may be authorised.
                              PART B
                              For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on azoxystrobin and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.
                              In this overall assessment Member States shall pay particular attention to:

                                          (1)

                                          the fact that the specification of the technical material as commercially manufactured must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material;

                                          (2)

                                          the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

                                          (3)

                                          the protection of aquatic organisms.

                                    The Member States must ensure that the conditions of authorisation include risk mitigation measures, where appropriate.
                              The Member States concerned shall request the submission of confirmatory information as regards the risk assessment on groundwater and aquatic organisms.
                              The notifier shall submit to the Member States, the Commission and the Authority such information by 31 December 2013.’

         (1)  Further details on identity and specification of active substance are provided in the review report.


title: Commission Implementing Regulation (EU) No 917/2014 of 22 August 2014 approving the active substance Streptomyces lydicus strain WYEC 108 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011  Text with EEA relevance

text:
               23.8.2014

               EN

               Official Journal of the European Union

               L 251/19

         COMMISSION IMPLEMENTING REGULATION (EU) No 917/2014
   of 22 August 2014
   approving the active substance Streptomyces lydicus strain WYEC 108 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) and Article 78(2) thereof,
   Whereas:

               (1)

               In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For Streptomyces lydicus strain WYEC 108 the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Implementing Decision 2011/253/EU (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC the Netherlandsreceived on 6 August 2010 an application from FuturEco Bioscience S.L. for the inclusion of the active substance Streptomyces lydicus strain WYEC 108 in Annex I to Directive 91/414/EEC. Implementing Decision 2011/253/EU confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

               (3)

               For that active substance, the effects on human and animal 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 applicant. The designated rapporteur Member State submitted a draft assessment report on 4 May 2012.

               (4)

               The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion on the pesticide risk assessment of the active substance Streptomyces lydicus strain WYEC 108 (4) on 14 October 2013. The draft assessment 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 within the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 in the format of the Commission review report for Streptomyces lydicus strain WYEC 108.

               (5)

               It has appeared from the various examinations made that plant protection products containing Streptomyces lydicus strain WYEC 108 may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve Streptomyces lydicus strain WYEC 108.

               (6)

               A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval.

               (7)

               Without prejudice to the obligations provided for in Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009, the following should, however, apply. Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing Streptomyces lydicus strain WYEC 108. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.

               (8)

               The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 (5) 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 to that Directive or the Regulations approving active substances.

               (9)

               In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (6) should be amended accordingly.

               (10)

               The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Approval of active substance
   The active substance Streptomyces lydicus strain WYEC 108, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
   Article 2
   Re-evaluation of plant protection products
   1.   Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing Streptomyces lydicus strain WYEC 108 as an active substance by 30 June 2015.
   By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing Streptomyces lydicus strain WYEC 108 as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 31 December 2014 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.
   Following that determination Member States shall:

               (a)

               in the case of a product containing Streptomyces lydicus strain WYEC 108 as the only active substance, where necessary, amend or withdraw the authorisation by 30 June 2016 at the latest; or

               (b)

               in the case of a product containing Streptomyces lydicus strain WYEC 108 as one of several active substances, where necessary, amend or withdraw the authorisation by 30 June 2016 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest.

         Article 3
   Amendments to Implementing Regulation (EU) No 540/2011
   The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
   Article 4
   Entry into force and date of application
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   It shall apply from 1 January 2015.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 22 August 2014.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 309, 24.11.2009, p. 1.

      (2)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

      (3)  Commission Implementing Decision 2011/253/EU of 26 April 2011 recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of metobromuron, S-Abscisic acid, Bacillus amyloliquefaciens subsp. plantarum D747, Bacillus pumilus QST 2808 and Streptomyces lydicus WYEC 108 in Annex I to Council Directive 91/414/EEC (OJ L 106, 27.4.2011, p. 13).

      (4)  EFSA Journal 2013;11(11):3425. Available online: www.efsa.europa.eu

      (5)  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 (OJ L 366, 15.12.1992, p. 10).

      (6)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

      ANNEX I

                  Common name, identification numbers

                  IUPAC name

                  Purity (1)

                  Date of approval

                  Expiration of approval

                  Specific provisions

                     Streptomyces lydicus strain WYEC 108
                  Collection number: American Type Culture Collection (USDA) ATCC 55445

                  Not applicable

                  Minimum concentration: 5,0 × 108 CFU/g

                  1 January 2015

                  31 December 2024

                  For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Streptomyces lydicus strain WYEC 108, and in particular Appendices I and II thereto, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to:

                              (a)

                              the risk to aquatic organisms;

                              (b)

                              the risk to soil dwelling organisms.

                        Conditions of use shall include risk mitigation measures, where appropriate.

         (1)  Further details on identity and specification of active substance are provided in the review report.

      ANNEX II
      In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

                     Number

                     Common name, identification numbers

                     IUPAC name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘79

                        Streptomyces lydicus strain WYEC 108
                     Collection number: American Type Culture Collection (USDA) ATCC 55445

                     Not applicable

                     Minimum concentration: 5,0 × 108 CFU/g

                     1 January 2015

                     31 December 2024

                     For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Streptomyces lydicus strain WYEC 108, and in particular Appendices I and II thereto, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 (a)

                                 the risk to aquatic organisms;

                                 (b)

                                 the risk to soil dwelling organisms.

                           Conditions of use shall include risk mitigation measures, where appropriate.’

         (1)  Further details on identity and specification of active substance are provided in the review report.


title: Commission Implementing Regulation (EU) No 1196/2013 of 22 November 2013 entering a name in the register of protected designations of origin and protected geographical indications [Stakliškės (PGI)]

text:
               26.11.2013

               EN

               Official Journal of the European Union

               L 315/32

         COMMISSION IMPLEMENTING REGULATION (EU) No 1196/2013
   of 22 November 2013
   entering a name in the register of protected designations of origin and protected geographical indications [Stakliškės (PGI)]
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,
   Whereas:

               (1)

               Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Lithuania’s application to register the name ‘Stakliškės’ was published in the Official Journal of the European Union
                   (2).

               (2)

               As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, that name should therefore be entered in the register,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The name contained in the Annex to this Regulation is hereby entered in the register.
   Article 2
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 22 November 2013.

            For the Commission, On behalf of the President,
         Dacian CIOLOȘ

            Member of the Commission

      (1)  OJ L 343, 14.12.2012, p. 1.

      (2)  OJ C 166, 12.6.2013, p. 8.

      ANNEX
      Agricultural products intended for human consumption listed in Annex I to the Treaty:

         Class 1.8.   Other products listed in Annex I to the Treaty (spices, etc.)

      LITHUANIA
      Stakliškės (PGI)


title: Commission Implementing Regulation (EU) No 762/2013 of 7 August 2013 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb, MCPA, MCPB and metiram  Text with EEA relevance

text:
               8.8.2013

               EN

               Official Journal of the European Union

               L 213/14

         COMMISSION IMPLEMENTING REGULATION (EU) No 762/2013
   of 7 August 2013
   amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb, MCPA, MCPB and metiram
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular the first paragraph of Article 17 thereof,
   Whereas:

               (1)

               Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (2) sets out the active substances deemed to have been approved under Regulation (EC) No 1107/2009.

               (2)

               The approvals of the active substances chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb, MCPA, MCPB and metiram will expire between 30 April 2016 and 30 June 2016. Applications have been submitted for the renewal of the approval of these active substances. As the requirements laid down in Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (3) apply to those active substances, it is necessary to allow applicants sufficient time to complete the renewal procedure in accordance with that Regulation. Consequently, the approvals of those active substances are likely to expire before a decision has been taken on their renewal. It is therefore necessary to extend their approval periods.

               (3)

               Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

               (4)

               In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where no supplementary dossier in accordance with Implementing Regulation (EU) No 844/2012 is submitted no later than 30 months before the respective expiry date laid down in the Annex to this Regulation, the Commission will set the expiry date at the same date as before this Regulation or at the earliest date thereafter.

               (5)

               In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where the Commission will adopt a Regulation providing that the approval of an active substance referred to in the Annex to this Regulation is not renewed because the approval criteria are not satisfied, the Commission will set the expiry date at the same date as before this Regulation or at the date of the entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later.

               (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,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 7 August 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 309, 24.11.2009, p. 1.

      (2)  OJ L 153, 11.6.2011, p. 1.

      (3)  OJ L 252, 19.9.2012, p. 26.

      ANNEX
      Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

                  (1)

                  In the sixth column, expiration of approval, of row 107, MCPA, the date ‘30 April 2016’ is replaced by ‘31 October 2017’.

                  (2)

                  In the sixth column, expiration of approval, of row 108, MCPB, the date ‘30 April 2016’ is replaced by ‘31 October 2017’.

                  (3)

                  In the sixth column, expiration of approval, of row 111, chlorpyrifos, the date ‘30 June 2016’ is replaced by ‘31 January 2018’.

                  (4)

                  In the sixth column, expiration of approval, of row 112, chlorpyrifos-methyl, the date ‘30 June 2016’ is replaced by ‘31 January 2018’.

                  (5)

                  In the sixth column, expiration of approval, of row 113, maneb, the date ‘30 June 2016’ is replaced by ‘31 January 2018’.

                  (6)

                  In the sixth column, expiration of approval, of row 114, mancozeb, the date ‘30 June 2016’ is replaced by ‘31 January 2018’.

                  (7)

                  In the sixth column, expiration of approval, of row 115, metiram, the date ‘30 June 2016’ is replaced by ‘31 January 2018’.