title: Commission Implementing Regulation (EU) No 1197/2012 of 13 December 2012 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances acetamiprid, alpha-cypermethrin, Ampelomyces quisqualis Strain: AQ 10, benalaxyl, bifenazate, bromoxynil, chlorpropham, desmedipham, etoxazole, Gliocladium catenulatum Strain: J1446, imazosulfuron, laminarin, mepanipyrim, methoxyfenozide, milbemectin, phenmedipham, Pseudomonas chlororaphis Strain: MA 342, quinoxyfen, S-metolachlor, tepraloxydim, thiacloprid, thiram and ziram Text with EEA relevance

text:
               14.12.2012

               EN

               Official Journal of the European Union

               L 342/27

         COMMISSION IMPLEMENTING REGULATION (EU) No 1197/2012
   of 13 December 2012
   amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances acetamiprid, alpha-cypermethrin, Ampelomyces quisqualis Strain: AQ 10, benalaxyl, bifenazate, bromoxynil, chlorpropham, desmedipham, etoxazole, Gliocladium catenulatum Strain: J1446, imazosulfuron, laminarin, mepanipyrim, methoxyfenozide, milbemectin, phenmedipham, Pseudomonas chlororaphis Strain: MA 342, quinoxyfen, S-metolachlor, tepraloxydim, thiacloprid, thiram and ziram
   (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 acetamiprid, alpha-cypermethrin, Ampelomyces quisqualis Strain: AQ 10, benalaxyl, bifenazate, bromoxynil, chlorpropham, desmedipham, etoxazole, Gliocladium catenulatum Strain: J1446, imazosulfuron, laminarin, mepanipyrim, methoxyfenozide, milbemectin, phenmedipham, Pseudomonas chlororaphis Strain: MA 342, quinoxyfen, S-metolachlor, tepraloxydim, thiacloprid, thiram and ziram will expire between 31 July 2014 and 30 November 2015. Applications have been submitted for the renewal 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) will apply to those active substances, it is necessary to allow sufficient time to complete the renewal procedure in accordance with that Regulation. Consequently, the approval of those active substances would be likely to expire before a decision has been taken on their renewal. It is therefore necessary to postpone the expiry of 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 within 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 adoption 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 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, 13 December 2012.

            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 entry 73, thiram, the date 31 July 2014 is replaced by 30 April 2017.

                  (2)

                  In sixth column, expiration of approval, of entry 74, ziram, the date 31 July 2014 is replaced by 30 April 2017.

                  (3)

                  In the sixth column, expiration of approval, of entry 82, quinoxyfen, the date 31 August 2014 is replaced by 30 April 2017.

                  (4)

                  In the sixth column, expiration of approval, of entry 89, Pseudomonas chlororaphis Strain: MA 342, the date 30 September 2014 is replaced by 30 April 2017.

                  (5)

                  In the sixth column, expiration of approval, of entry 90, mepanipyrim, the date 30 September 2014 is replaced by 30 April 2017.

                  (6)

                  In the sixth column, expiration of approval, of entry 91, acetamiprid, the date 31 December 2014 is replaced by 30 April 2017.

                  (7)

                  In the sixth column, expiration of approval, of entry 92, thiacloprid, the date 31 December 2014 is replaced by 30 April 2017.

                  (8)

                  In the sixth column, expiration of approval, of entry 78, chlorpropham, the date 31 January 2015 is replaced by 31 July 2017.

                  (9)

                  In the sixth column, expiration of approval, of entry 83, alpha-cypermethrin, the date 28 February 2015 is replaced by 31 July 2017.

                  (10)

                  In the sixth column, expiration of approval, of entry 84, benalaxyl, the date 28 February 2015 is replaced by 31 July 2017.

                  (11)

                  In the sixth column, expiration of approval, of entry 85, bromoxynil, the date 28 February 2015 is replaced by 31 July 2017.

                  (12)

                  In the sixth column, expiration of approval, of entry 86, desmedipham, the date 28 February 2015 is replaced by 31 July 2017.

                  (13)

                  In the sixth column, expiration of approval, of entry 88, phenmedipham, the date 28 February 2015 is replaced by 31 July 2017.

                  (14)

                  In the sixth column, expiration of approval, of entry 93, Ampelomyces quisqualis Strain: AQ 10, the date 31 March 2015 is replaced by 31 July 2017.

                  (15)

                  In the sixth column, expiration of approval, of entry 94, imazosulfuron, the date 31 March 2015 is replaced by 31 July 2017.

                  (16)

                  In the sixth column, expiration of approval, of entry 95, laminarin, the date 31 March 2015 is replaced by 31 July 2017.

                  (17)

                  In the sixth column, expiration of approval, of entry 96, methoxyfenozide, the date 31 March 2015 is replaced by 31 July 2017.

                  (18)

                  In the sixth column, expiration of approval, of entry 97, S-metolachlor, the date 31 March 2015 is replaced by 31 July 2017.

                  (19)

                  In the sixth column, expiration of approval, of entry 98 Gliocladium catenulatum Strain: J1446, the date 31 March 2015 is replaced by 31 July 2017.

                  (20)

                  In the sixth column, expiration of approval, of entry 99, etoxazole, the date 31 May 2015 is replaced by 31 July 2017.

                  (21)

                  In the sixth column, expiration of approval, of entry 100, tepraloxydim, the date 31 May 2015 is replaced by 31 July 2017.

                  (22)

                  In the sixth column, expiration of approval, of entry 109, bifenazate, the date 30 November 2015 is replaced by 31 July 2017.

                  (23)

                  In the sixth column, expiration of approval, of entry 110, milbemectin, the date 30 November 2015 is replaced by 31 July 2017.


title: Commission Implementing Regulation (EU) No 666/2012 of 20 July 2012 amending Regulations (EC) No 2092/2004, (EC) No 793/2006, (EC) No 1914/2006, (EC) No 1120/2009, (EC) No 1121/2009, (EC) No 1122/2009, (EU) No 817/2010 and (EU) No 1255/2010 as regards the notification obligations within the common organisation of agricultural markets and the direct support schemes for farmers

text:
               21.7.2012

               EN

               Official Journal of the European Union

               L 194/3

         COMMISSION IMPLEMENTING REGULATION (EU) No 666/2012
   of 20 July 2012
   amending Regulations (EC) No 2092/2004, (EC) No 793/2006, (EC) No 1914/2006, (EC) No 1120/2009, (EC) No 1121/2009, (EC) No 1122/2009, (EU) No 817/2010 and (EU) No 1255/2010 as regards the notification obligations within the common organisation of agricultural markets and the direct support schemes for farmers
   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 192(2), in conjunction with Article 4 thereof,
   Having regard to Council Regulation (EC) No 73/2009 of 19 January 2009 establishing common rules for direct support schemes for farmers under the common agricultural policy and establishing certain support schemes for farmers, amending Regulations (EC) No 1290/2005, (EC) No 247/2006, (EC) No 378/2007 and repealing Regulation (EC) No 1782/2003 (2), and in particular Article 142(q) thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 792/2009 of 31 August 2009 laying down detailed rules for the Member States' notification to the Commission of information and documents in implementation of the common organisation of the markets, the direct payments′ regime, the promotion of agricultural products and the regimes applicable to the outermost regions and the smaller Aegean islands (3), lays down common rules for notifying information and documents by the competent authorities of the Member States to the Commission. Those rules cover in particular the obligation for the Member States to use the information systems made available by the Commission and the validation of the access rights of the authorities or individuals authorised to send notifications. In addition, that Regulation sets common principles applying to the information systems so that they guarantee the authenticity, integrity and legibility over time of the documents and provides for personal data protection.

               (2)

               Pursuant to Regulation (EC) No 792/2009, the obligation to use the information systems in accordance with that Regulation has to be provided for in the Regulations establishing a specific notification obligation.

               (3)

               The Commission has developed an information system that allows managing documents and procedures electronically in its own internal working procedures and in its relations with the authorities involved in the common agricultural policy.

               (4)

               It is considered that several notification obligations can be fulfilled via that system in accordance with Regulation (EC) No 792/2009, in particular those provided for in Commission Regulations (EC) No 2092/2004 of 8 December 2004 laying down detailed rules of application for an import tariff quota of dried boneless beef originating in Switzerland (4), (EC) No 793/2006 of 12 April 2006 laying down certain detailed rules for applying Council Regulation (EC) 247/2006 laying down specific measures for agriculture in the outermost regions of the Union (5), (EC) No 1914/2006 of 20 December 2006 laying down detailed rules for applying Council Regulation (EC) No 1405/2006 laying down specific measures for agriculture in favour of the smaller Aegean islands (6), (EC) No 1120/2009 of 29 October 2009 laying down detailed rules for the implementation of the single payment scheme provided for in Title III of Council Regulation (EC) No 73/2009 establishing common rules for direct support schemes for farmers under the common agricultural policy and establishing certain support schemes for farmers (7), (EC) No 1121/2009 of 29 October 2009 laying down detailed rules for the application of Council Regulation (EC) No 73/2009 as regards the support schemes for farmers provided for in Titles IV and V thereof (8), (EC) No 1122/2009 of 30 November 2009 laying down detailed rules for the implementation of Council Regulation (EC) No 73/2009 as regards cross-compliance, modulation and the integrated administration and control system, under the direct support schemes for farmers provided for that Regulation, as well as for the implementation of Council Regulation (EC) No 1234/2007 as regards cross-compliance under the support scheme provided for the wine sector (9), (EU) No 817/2010 of 16 September 2010 laying down detailed rules pursuant to Council Regulation (EC) No 1234/2007 as regards requirements for the granting of export refunds related to the welfare of live bovine animals during transport (10), (EU) No 1255/2010 of 22 December 2010 laying down detailed rules for the application of the import tariff quotas for ‘baby beef’ products originating in Bosnia and Herzegovina, Croatia, the former Yugoslav Republic of Macedonia, Montenegro and Serbia (11).

               (5)

               In the interest of efficient administration and taking account of the experience, some notifications should be either simplified and specified or deleted in those Regulations.

               (6)

               Regulations (EC) No 2092/2004, (EC) No 793/2006, (EC) No 1914/2006, (EC) No 1120/2009, (EC) No 1121/2009, (EC) No 1122/2009, (EU) No 817/2010 and (EU) No 1255/2010 should therefore be amended accordingly.

               (7)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Regulation (EC) No 2092/2004 is amended as follows:

               (1)

               In Article 7a, paragraphs 2 and 3 are replaced by the following:
               "2.   Member States shall notify the Commission of the details of the quantities of products put into free circulation in accordance with Article 4 of Regulation (EC) No 1301/2006.
               3.   The notifications referred to in paragraph 1 shall be made in accordance with Commission Regulation (EC) No 792/2009 (12) and the product categories indicated in Annex V to Regulation (EC) No 382/2008 shall be used.

               (2)

               Annexes IV, V and VI are deleted.

         Article 2
   Regulation (EC) No 793/2006 is amended as follows:

               (1)

               In Article 47, the following paragraph 3 is added:
               "3.   The communications referred to in this Article shall be made in accordance with Commission Regulation (EC) No 792/2009 (13).

               (2)

               In Article 48, the following paragraph 3 is added:
               "3.   The communications and reports referred to in Article 28(1) and (2) of Regulation (EC) No 247/2006 shall be made and submitted in accordance with Regulation (EC) No 792/2009."

         Article 3
   Regulation (EC) No 1914/2006 is amended as follows:

               (1)

               In Article 32, the following paragraph 3 is added:
               "3.   The communications referred to in this Article shall be made in accordance with Commission Regulation (EC) No 792/2009 (14).

               (2)

               In Article 33, the following paragraph 3 is added:
               "3.   The communications and reports referred to in Article 17 (1) and (2) of Regulation (EC) No 1405/2006 shall be made in accordance with Regulation (EC) No 792/2009."

         Article 4
   In Regulation (EC) No 1120/2009, the following Article 51a is inserted:

      "Article 51a
      The notifications referred to in this Regulation, with the exception of Article 51(4) shall be made in accordance with Commission Regulation (EC) No 792/2009 (15).
      The notifications referred to in Article 51(3) shall be made in accordance with Regulation (EC) No 792/2009 only as from 1 January 2013.

   Article 5
   Regulation (EC) No 1121/2009 is amended as follows:

               (1)

               Article 4(1) is amended as follows:

                           (a)

                           in point (a)(i), the first, second and third indents are deleted,

                           (b)

                           point (b) is deleted,

                           (c)

                           point (c) is amended as follows:

                                       (i)

                                       in point (i), the first and second indents are deleted,

                                       (ii)

                                       point (ii) is deleted,

                           (d)

                           points (d) and (e) are deleted.

               (2)

               The following Article 94a is inserted.
               "Article 94a
               The notifications referred to in this Regulation shall be made in accordance with Commission Regulation (EC) No 792/2009 (16).

         Article 6
   In Article 84 of Regulation (EC) No 1122/2009, paragraph 6 is replaced by the following:

      "6.   The notifications referred to in Article 40 and paragraphs 2 and 5 of this Article shall be made in accordance with Commission Regulation (EC) No 792/2009 (17).

   Article 7
   In Article 8 of Regulation (EU) No 817/2010, the following paragraph is added:

      "The communications referred to in this Article shall be made in accordance with Commission Regulation (EC) No 792/2009 (18);

   Article 8
   Regulation (EU) No 1255/2010 is amended as follows:

               (1)

               In Article 8, paragraphs 2 and 3 are replaced by the following:
               "2.   Member States shall notify the Commission of the details of the quantities of products put into free circulation in accordance with Article 4 of Regulation (EC) No 1301/2006.
               3.   The notifications referred to in paragraph 1 shall be made in accordance with Commission Regulation (EC) No 792/2009 (19) and the product categories indicated in Annex V to Regulation (EC) No 382/2008 shall be used.

               (2)

               Annexes VIII, IX and X are deleted.

         Article 9
   This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
   It shall apply from 16 August 2012. However, Articles 1 and 8 shall apply from 1 January 2013.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 20 July 2012.

            For the Commission

            The President

         José Manuel BARROSO

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

      (2)  OJ L 30, 31.1.2009, p. 16.

      (3)  OJ L 228, 1.9.2009, p. 3.

      (4)  OJ L 362, 9.12.2004, p. 4.

      (5)  OJ L 145, 31.5.2006, p. 1.

      (6)  OJ L 365, 21.12.2006, p. 64.

      (7)  OJ L 316, 2.12.2009, p. 1.

      (8)  OJ L 316, 2.12.2009, p. 27.

      (9)  OJ L 316, 2.12.2009, p. 65.

      (10)  OJ L 245, 17.9.2010, p. 16.

      (11)  OJ L 342, 28.12.2010, p. 1.

      (12)  OJ L 228, 1.9.2009, p. 3."

      (13)  OJ L 228, 1.9.2009, p. 3."

      (14)  OJ L 228, 1.9.2009, p. 3."

      (15)  OJ L 228, 1.9.2009, p. 3."

      (16)  OJ L 228, 1.9.2009, p. 3."

      (17)  OJ L 228, 1.9.2009, p. 3."

      (18)  OJ L 228, 1.9.2009, p. 3."

      (19)  OJ L 228, 1.9.2009, p. 3."


title: Commission Implementing Regulation (EU) No 705/2011 of 20 July 2011 approving the active substance imazalil, 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 190/43

         COMMISSION IMPLEMENTING REGULATION (EU) No 705/2011
   of 20 July 2011
   approving the active substance imazalil, 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. Imazalil is listed in Annex I to Regulation (EC) No 737/2007.

               (2)

               The approval of imazalil, 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 imazalil 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 9 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 imazalil (6) to the Commission on 4 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 imazalil.

               (8)

               It has appeared from the various examinations made that plant protection products containing imazalil 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 imazalil.

               (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 supports a lower level of purity compared to that set out in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011, and taking into account that no toxicologically or ecotoxicologically significant impurities are present, the purity level should be modified.

               (11)

               From the new data submitted, it appears that imazalil and its degradation products in soil and surface water systems may cause risks for soil micro-organisms and aquatic organisms; negligible groundwater exposure needs to be confirmed; further investigation is needed on the nature of residues in processed commodities. Without prejudice to the conclusion that imazalil 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 imazalil. 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 2010/57/EU of 26 August 2010 amending Annex I to Council Directive 91/414/EEC to renew the inclusion of imazalil 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 imazalil, 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 imazalil 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 imazalil 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 imazalil 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 imazalil 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 2010/57/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 imazalil on request from the European Commission EFSA Journal 2010; 8(3):1526.

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

      (8)  OJ L 225, 27.8.2010, p. 5.

      ANNEX I

                  Common Name, Identification Numbers

                  IUPAC Name

                  Purity (1)

                  Date of approval

                  Expiration of approval

                  Specific provisions

                  Imazalil
                  CAS No 35554-44-0
                  73790-28-0 (replaced)
                  CIPAC No 335

                  (RS)-1-(β-allyloxy-2,4-dichlorophenethyl)imidazole
                  or
                  allyl (RS)-1-(2,4-dichlorophenyl)-2-imidazol-1-ylethyl ether

                  ≥ 950 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 imazalil, 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:

                              (1)

                              pay particular attention to 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)

                              pay particular attention to the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels;

                              (3)

                              pay particular attention to the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure;

                              (4)

                              ensure that appropriate waste management practices to handle the waste solution remaining after application, such as the cleaning water of the drenching system and the discharge of the processing waste are put in place. Prevention of any accidental spillage of treatment solution. Member States permitting the release of waste water into the sewage system shall ensure that a local risk assessment is carried out;

                              (5)

                              pay particular attention to risk to aquatic organisms and soil micro-organisms and long-term risk to granivorous birds and mammals.

                        Conditions of authorisation shall include risk mitigation measures, where appropriate.
                  The notifier shall submit confirmatory information as regards:

                              (a)

                              route of degradation of imazalil in soil and surface water systems;

                              (b)

                              environmental data to support the managing measures that Member States have to put in place to ensure that groundwater exposure is negligible;

                              (c)

                              a hydrolysis study to investigate the nature of residues in processed commodities.

                        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 imazalil 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

                              ‘5

                              Imazalil
                              CAS No 35554-44-0
                              73790-28-0 (replaced)
                              CIPAC No 335

                              (RS)-1-(β-allyloxy-2,4-dichlorophenethyl)imidazole
                              or
                              allyl (RS)-1-(2,4-dichlorophenyl)-2-imidazol-1-ylethyl ether

                              ≥ 950 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 imazalil, 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:

                                          (1)

                                          pay particular attention to 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)

                                          pay particular attention to the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels;

                                          (3)

                                          pay particular attention to the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure;

                                          (4)

                                          ensure that appropriate waste management practices to handle the waste solution remaining after application, such as the cleaning water of the drenching system and the discharge of the processing waste are put in place. Prevention of any accidental spillage of treatment solution. Member States permitting the release of waste water into the sewage system shall ensure that a local risk assessment is carried out;

                                          (5)

                                          pay particular attention to risk to aquatic organisms and soil micro-organisms and long-term risk to granivorous birds and mammals.

                                    Conditions of authorisation shall include risk mitigation measures, where appropriate.
                              The notifier shall submit confirmatory information as regards:

                                          (a)

                                          route of degradation of imazalil in soil and surface water systems;

                                          (b)

                                          environmental data to support the managing measures that Member States have to put in place to ensure that groundwater exposure is negligible;

                                          (c)

                                          a hydrolysis study to investigate the nature of residues in processed commodities.

                                    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 1195/2013 of 22 November 2013 approving the active substance sodium silver thiosulfate, 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:
               26.11.2013

               EN

               Official Journal of the European Union

               L 315/27

         COMMISSION IMPLEMENTING REGULATION (EU) No 1195/2013
   of 22 November 2013
   approving the active substance sodium silver thiosulfate, 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 sodium silver thiosulfate, referred to in Commission Decision 2003/850/EC (3) as silver thiosulfate, the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by that Decision.

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC the Netherlands received on 27 January 2003 an application from Enhold B.V for the inclusion of the active substance sodium silver thiosulfate in Annex I to Directive 91/414/EEC. Decision 2003/850/EC 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 July 2005. In accordance with Article 11(6) of Commission Regulation (EU) No 188/2011 (4) additional information was requested from the applicant on 1 February 2012. The evaluation of the additional data by the Netherlands was submitted in the format of an updated draft assessment report in November 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 sodium silver thiosulfate (5) on 1 March 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 on 3 October 2013 in the format of the Commission review report for sodium silver thiosulfate.

               (5)

               It has appeared from the various examinations made that plant protection products containing sodium silver thiosulfate 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 sodium silver thiosulfate.

               (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 sodium silver thiosulfate. 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 (6) 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 (7) should be amended accordingly.

               (10)

               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 sodium silver thiosulfate, 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 sodium silver thiosulfate as an active substance by 31 October 2014.
   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 sodium silver thiosulfate 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 30 April 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 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 sodium silver thiosulfate as the only active substance, where necessary, amend or withdraw the authorisation by 31 October 2015 at the latest; or

               (b)

               in the case of a product containing sodium silver thiosulfate as one of several active substances, where necessary, amend or withdraw the authorisation by 31 October 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 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 May 2014.

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

            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 Decision 2003/850/EC of 4 December 2003 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of BAS 670H and silver thiosulphate in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market (OJ L 322, 9.12.2003, p. 28).

      (4)  Commission Regulation (EU) No 188/2011 of 25 February 2011 laying down detailed rules for the implementation of Council Directive 91/414/EEC as regards the procedure for the assessment of active substances which were not on the market 2 years after the date of notification of that Directive (OJ L 53, 26.2.2011, p. 51).

      (5)  EFSA Journal 2013; 11(3):3136. Available online: www.efsa.europa.eu

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

      (7)  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

                  Sodium silver thiosulfate
                  CAS No not allocated
                  CIPAC No 762

                  Not applicable

                  ≥ 10,0 g Ag/kg
                  Expressed as silver (Ag)

                  1 May 2014

                  30 April 2024

                  PART A
                  Only indoor uses in non-edible crops shall 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 sodium silver thiosulfate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to:

                              (a)

                              the protection of operators and workers;

                              (b)

                              limiting the possible release of silver ions through disposal of used solutions;

                              (c)

                              the risk to terrestric vertebrates and soil invertebrates from the use of sewage sludge in agriculture.

                        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

                     ‘63

                     Sodium silver thiosulfate
                     CAS No not allocated
                     CIPAC No 762

                     Not applicable

                     ≥ 10,0 g Ag/kg
                     Expressed as silver (Ag)

                     1 May 2014

                     30 April 2024

                     PART A
                     Only indoor uses in non-edible crops shall 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 sodium silver thiosulfate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to

                                 (a)

                                 the protection of operators and workers;

                                 (b)

                                 limiting the possible release of silver ions through disposal of used solutions;

                                 (c)

                                 the risk to terrestric vertebrates and soil invertebrates from the use of sewage sludge in agriculture.

                           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 190/2013 of 5 March 2013 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance sodium hypochlorite  Text with EEA relevance

text:
               6.3.2013

               EN

               Official Journal of the European Union

               L 62/19

         COMMISSION IMPLEMENTING REGULATION (EU) No 190/2013
   of 5 March 2013
   amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance sodium hypochlorite
   (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 substance sodium hypochlorite was 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, this substance is deemed to have been approved under that Regulation and is 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 view on the draft review report for sodium hypochlorite (6) on 25 June 2012. The Authority communicated its view on sodium hypochlorite to the notifier. The Commission invited it to submit comments on the draft review report for sodium hypochlorite. The draft review report and the view 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 February 2013 in the format of the Commission review report for sodium hypochlorite.

               (3)

               It is confirmed that the active substance sodium hypochlorite is to be deemed to have been approved under Regulation (EC) No 1107/2009.

               (4)

               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 sodium hypochlorite. Despite comprehensive information on sodium hypochlorite as generally available commodity substance exists, if only data provided by the notifier are taken into account, the exposure assessment to operator, worker and surface water could not be finalised. Therefore, it is opportune to restrict the authorisations to indoor uses and to insert some new provisions for the Member States granting authorisations for plant protection products containing sodium hypochlorite.

               (5)

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

               (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 July 2013.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 5 March 2013.

            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)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance sodium hypochlorite. EFSA Journal 2012; 10(7):2796. [40 pp.] doi:10.2903/j.efsa.2012.2796. Available online: www.efsa.europa.eu/efsajournal

      ANNEX
      In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 254 on the active substance sodium hypochlorite is replaced by the following:

                     Number

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘254

                     Sodium hypochlorite
                     CAS No: 7681-52-9
                     CIPAC: 848

                     Sodium hypochlorite

                     Sodium hypochlorite: 105 g/kg-126 g/kg (122 g/L-151 g/L) technical concentrate
                     10-12 % (w/w) expressed as chlorine

                     1 September 2009

                     31 August 2019

                     PART A
                     Only indoor uses as disinfectant 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 sodium hypochlorite (SANCO/2988/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 (a)

                                 the risk to operator and workers;

                                 (b)

                                 the exposure of soil to sodium hypochlorite and its reaction products through spreading of treated compost on organic land shall be avoided.

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

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


title: Commission Implementing Regulation (EU) No 1116/2012 of 28 November 2012 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               29.11.2012

               EN

               Official Journal of the European Union

               L 329/16

         COMMISSION IMPLEMENTING REGULATION (EU) No 1116/2012
   of 28 November 2012
   establishing the standard import values for determining the entry price of certain fruit and vegetables
   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),
   Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,
   Whereas:

               (1)

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

               (2)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the day 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, 28 November 2012.

            For the Commission, On behalf of the President,
         José Manuel SILVA RODRÍGUEZ

            Director-General for Agriculture and Rural Development

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

      (2)  OJ L 157, 15.6.2011, p. 1.

      ANNEX
      Standard import values for determining the entry price of certain fruit and vegetables

                  (EUR/100 kg)

                  CN code

                  Third country code (1)

                  Standard import value

                  0702 00 00

                  AL

                  50,7

                  MA

                  53,2

                  MK

                  37,4

                  TN

                  74,5

                  TR

                  64,0

                  ZZ

                  56,0

                  0707 00 05

                  AL

                  70,7

                  MA

                  141,4

                  MK

                  58,4

                  TR

                  93,7

                  ZZ

                  91,1

                  0709 93 10

                  MA

                  90,7

                  TR

                  88,8

                  ZZ

                  89,8

                  0805 20 10

                  MA

                  78,6

                  ZZ

                  78,6

                  0805 20 30, 0805 20 50, 0805 20 70, 0805 20 90

                  CN

                  70,9

                  HR

                  45,0

                  TR

                  84,5

                  ZZ

                  66,8

                  0805 50 10

                  AR

                  68,7

                  TR

                  78,4

                  ZZ

                  73,6

                  0808 10 80

                  MK

                  38,5

                  NZ

                  138,3

                  US

                  182,4

                  ZA

                  88,7

                  ZZ

                  112,0

                  0808 30 90

                  CN

                  66,2

                  TR

                  116,3

                  ZZ

                  91,3

         (1)  Nomenclature of countries laid down by Commission Regulation (EC) No 1833/2006 (OJ L 354, 14.12.2006, p. 19). Code ‘ZZ’ stands for ‘of other origin’.


title: Commission Implementing Regulation (EU) No 154/2014 of 19 February 2014 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance extract from tea tree  Text with EEA relevance

text:
               20.2.2014

               EN

               Official Journal of the European Union

               L 50/7

      COMMISSION IMPLEMENTING REGULATION (EU) No 154/2014
   of 19 February 2014
   amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance extract from tea tree
   (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) and Article 78(2) thereof,
   Whereas:

               (1)

               The active substance extract from tea tree was 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 (4). Since the replacement of Directive 91/414/EEC by Regulation (EC) No 1107/2009, this substance is deemed to have been approved under that Regulation and is listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (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 view on the draft review report for extract from tea tree (6) on 16 December 2011. The Authority communicated its views on extract from tea tree to the notifier. The Commission invited it to submit comments on the draft review report for extract from tea tree. The draft review report and the view 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 13 December 2013 in the format of the Commission review report for extract from tea tree.

               (3)

               It is confirmed that the active substance extract from tea tree is to be deemed to have been approved under Regulation (EC) No 1107/2009.

               (4)

               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. It is, in particular, appropriate to require further confirmatory information.

               (5)

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

               (6)

               Member States should be provided with time to amend or withdraw authorisations for plant protection products containing extract from tea tree.

               (7)

               For plant protection products containing extract from tea tree, where Member States grant any period of grace in accordance with Article 46 of Regulation (EC) No 1107/2009, this period should expire at the latest 18 months from the date of entry into force of this Regulation.

               (8)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Amendment to Implementing Regulation (EU) No 540/2011
   Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.
   Article 2
   Transitional measures
   Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary amend or withdraw existing authorisations for plant protection products containing extract from tea tree as active substance by 12 September 2014.
   Article 3
   Grace period
   Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire on 12 September 2015 at the latest.
   Article 4
   Entry into force
   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, 19 February 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 Directive 2008/127/EC of 18 December 2008 amending Council Directive 91/414/EEC to include several active substances (OJ L 344, 20.12.2008, p. 89.)

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

      (5)  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).

      (6)  Conclusion on the peer review of the pesticide risk assessment of the active substance extract from tea tree, EFSA Journal 2012; 10(2):2542. Available online: www.efsa.europa.eu/efsajournal.htm

      ANNEX
      In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 228 on the active substance extract from tea tree is replaced by the following:

                     Number

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘228

                     Extract from tea tree
                     CAS No Tea Tree Oil 68647-73-4
                     Main components:

                                 terpinen-4-ol 562-74-3

                                 γ-terpinene 99-85-4

                                 α-terpinene 99-86-5

                                 1,8-cineole 470-82-6

                           CIPAC No 914

                     Tea Tree Oil is a complex mixture of chemical substances.

                                 Main components:

                                             terpinen-4-ol ≥ 300 g/kg

                                             γ-terpinene ≥ 100 g/kg

                                             α-terpinene ≥ 50 g/kg

                                             1,8-cineole ≥ 1 g/kg

                                 Relevant impurity:
                                 Methyl eugenol: maximum 1 g/kg of the technical material

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as fungicide in greenhouse 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 extract from tea tree (SANCO/2609/2008 final) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to

                                 —

                                 the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate;

                                 —

                                 the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;

                                 —

                                 the protection of surface water and aquatic organisms;

                                 —

                                 the protection of honey bees, non-target arthropods, earthworms and non-target micro- and macro-organisms.

                           Conditions of use shall include risk mitigation measures, where appropriate.
                     The notifier shall submit confirmatory information as regards:

                                 (a)

                                 the plant metabolism and consumer exposure;

                                 (b)

                                 the toxicity of the compounds that constitute the extract and the relevance of possible impurities other than methyl eugenol;

                                 (c)

                                 the groundwater exposure for the less strongly absorbed components that constitute the extract and for potential soil transformation products;

                                 (d)

                                 the effects on biological methods of sewage treatment.

                           The notifier shall submit to the Commission, the Member States and the Authority that information by 30 April 2016 at latest.’

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


title: Commission Implementing Regulation (EU) No 916/2014 of 22 August 2014 approving the basic substance sucrose 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 251/16

         COMMISSION IMPLEMENTING REGULATION (EU) No 916/2014
   of 22 August 2014
   approving the basic substance sucrose 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 23(5) in conjunction with Article 13(2) thereof,
   Whereas:

               (1)

               In accordance with Article 23(3) of Regulation (EC) No 1107/2009, the Commission received on 24 April 2013 an application from ITAB for the approval of sucrose as basic substance. That application was accompanied by the information required by the second subparagraph of Article 23(3).

               (2)

               The Commission asked the European Food Safety Authority (hereinafter ‘the Authority’) for scientific assistance. The Authority presented to the Commission a Technical Report on the substance concerned on 12 June 2014 (2). The Commission presented the review report (3) and the draft of this Regulation on the approval of sucrose to the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014.

               (3)

               The documentation provided by the applicant shows that sucrose fulfils the criteria of a foodstuff as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (4). Moreover, it is not predominantly used for plant protection purposes but nevertheless is useful in plant protection in a product consisting of the substance and water. Consequently, it is to be considered as a basic substance.

               (4)

               It has appeared from the examinations made that sucrose may be expected to satisfy, in general, the requirements laid down in Article 23 of Regulation (EC) No 1107/2009, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve sucrose as a basic substance.

               (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, however, necessary to include certain conditions for the approval which are detailed in Annex I to this Regulation.

               (6)

               In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (5) should be amended accordingly.

               (7)

               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 a basic substance
   The substance sucrose as specified in Annex I is approved as basic substance subject to the conditions laid down in that Annex.
   Article 2
   Amendments to Implementing Regulation (EU) No 540/2011
   Part C of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
   Article 3
   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.

      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)  Outcome of the consultation with Member States and EFSA on the basic substance application for sucrose/saccharoseand the conclusions drawn by EFSA on the specific points raised. 2014:EN-616, 27 pp.

      (3)  http://ec.europa.eu/sanco_pesticides/public/?event=homepage

      (4)  Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

      (5)  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

                  Specific provisions

                  Sucrose
                  CAS no: 57-50-1

                  α-D-glucopyranosyl-(1→2)-β-D-fructofuranoside or β-D-fructofuranosyl-(2→1)-α-D-glucopyranoside

                  Food grade

                  1 January 2015

                  Only uses as basic substance being an elicitor of the crop's natural defence mechanisms are approved.
                  Sucrose shall be used in accordance with the specific conditions included in the conclusions of the review report on sucrose (SANCO/11406/2014) and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014.

         (1)  Further details on identity, specification and manner of use of basic substance are provided in the review report.

      ANNEX II
      In Part C 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

                     Specific provisions

                     ‘3

                     Sucrose
                     CAS no: 57-50-1

                     α-D-glucopyranosyl-(1→2)-β-D-fructofuranoside or β-D-fructofuranosyl-(2→1)-α-D-glucopyranoside

                     Food grade

                     1 January 2015

                     Only uses as basic substance being an elicitor of the crop's natural defence mechanisms are approved.
                     Sucrose shall be used in accordance with the specific conditions included in the conclusions of the review report on sucrose (SANCO/11406/2014) and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014.’

         (1)  Further details on identity, specification and manner of use of basic substance are provided in the review report.