title: Commission Implementing Regulation (EU) No 993/2011 of 6 October 2011 approving the active substance 8-hydroxyquinoline, 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:
               7.10.2011

               EN

               Official Journal of the European Union

               L 263/1

         COMMISSION IMPLEMENTING REGULATION (EU) No 993/2011
   of 6 October 2011
   approving the active substance 8-hydroxyquinoline, 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)(c) 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 completeness has been established in accordance with Article 6 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). 8-hydroxyquinoline 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 lists of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. These lists included 8-hydroxyquinoline.

               (3)

               For 8-hydroxyquinoline no complete dossier was submitted within the prescribed time limit. Consequently, Commission Decision 2006/797/EC of 22 November 2006 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 (6) was adopted on the non-inclusion of 8-hydroxyquinoline.

               (4)

               Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier (hereinafter ‘the applicant’) submitted a new application requesting the regular procedure to be applied, as provided for in Articles 3 to 12 of Regulation (EC) No 33/2008.

               (5)

               The application was submitted to Spain, which had been designated rapporteur Member State by Regulation (EC) No 1490/2002. That application complies with the substantive and procedural requirements of Articles 3 and 4 of Regulation (EC) No 33/2008.

               (6)

               Spain evaluated the information submitted and prepared a draft assessment report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 3 August 2009. The Authority communicated the draft assessment report to the other Member States and the applicant for comments and forwarded the comments received to the Commission. The Authority also made the draft assessment report available to the public. In accordance with Article 10 of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on the risk assessment of 8-hydroxyquinoline to the Commission on 17 December 2010 (7). 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 15 July 2011 in the format of the Commission review report for 8-hydroxyquinoline.

               (7)

               It has appeared from the various examinations made that plant protection products containing 8-hydroxyquinoline 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 8-hydroxyquinoline 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 8-hydroxyquinoline should be approved, it is, in particular, appropriate to require further confirmatory information.

               (10)

               In accordance with Article 13(4) of Regulation (EC) No 1107/2009 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 (8) should be amended accordingly.

               (11)

               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 8-hydroxyquinoline, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
   Article 2
   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 3
   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, 6 October 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 324, 23.11.2006, p. 8.

      (7)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance 8-hydroxyquinoline. EFSA Journal 2011;9(1):1964 [49pp.] doi:10.2903/j.efsa.2011.1964. Available online: www.efsa.europa.eu/efsajournal.htm

      (8)  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

                  8-hydroxyquinoline
                  CAS No
                  148-24-3 (8-hydroxyquinoline)
                  CIPAC No 677
                  (8-hydroxyquinoline)

                  8-quinolinol

                  ≥ 990 g/kg

                  1 January 2012

                  31 December 2021

                  PART A
                  Only uses as fungicide and bactericide in greenhouses 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 8-hydroxyquinoline, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 July 2011 shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to the operator safety and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate.
                  The applicant shall submit confirmatory information on 8-hydroxyquinoline and its salts as regards:

                              (1)

                              the method of analysis for air;

                              (2)

                              a new storage stability covering the storage time periods of samples from both the metabolism study and from the supervised reidue trials.

                        The applicant shall submit to the Commission, the Member States 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
      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

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘18

                     8-hydroxyquinoline
                     CAS No
                     148-24-3 (8-hydroxyquinoline)
                     CIPAC No 677
                     (8-hydroxyquinoline)

                     8-quinolinol

                     ≥ 990 g/kg

                     1 January 2012

                     31 December 2021

                     PART A
                     Only uses as fungicide and bactericide in greenhouses 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 8-hydroxyquinoline, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 July 2011 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to the operator safety and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate.
                     The applicant shall submit confirmatory information on 8-hydroxyquinoline and its salts as regards:

                                 (1)

                                 the method of analysis for air;

                                 (2)

                                 a new storage stability covering the storage time periods of samples from both the metabolism study and from the supervised reidue trials.

                           The applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013.’


title: Commission Implementing Regulation (EU) 2015/232 of 13 February 2015 amending and correcting Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance copper compounds  Text with EEA relevance

text:
               14.2.2015

               EN

               Official Journal of the European Union

               L 39/7

         COMMISSION IMPLEMENTING REGULATION (EU) 2015/232
   of 13 February 2015
   amending and correcting Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance copper compounds
   (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 second alternative of Article 21(3) and Article 78(2) thereof,
   Whereas:

               (1)

               Commission Directive 2009/37/EC (2) included copper compounds as active substance in Annex I to Council Directive 91/414/EEC (3), under the condition that the Member States concerned ensure that the notifier at whose request copper compounds were included in that Annex provides further confirmatory information on the risk from inhalation and on the risk assessment for non-target organisms and for soil and water.

               (2)

               Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

               (3)

               The notifier submitted additional information taking the form of studies on the risk from inhalation and on the risk assessment for non-target organisms and for soil and water to the rapporteur Member State France within the time period provided for its submission.

               (4)

               France assessed the additional information submitted by the notifier. It submitted its assessment, in the form of an addendum to the draft assessment report, to the other Member States, the Commission and the European Food Safety Authority, hereinafter 'the Authority', on 8 June 2012.

               (5)

               The Commission consulted the Authority which presented its opinion on the risk assessment of copper compounds on 22 May 2013 (5).

               (6)

               The Commission invited the notifier to submit its comments on the review report for copper compounds.

               (7)

               In the light of the additional information provided by the notifier, the Commission considered that the further confirmatory information required had not been fully provided and that, in particular, the specific provision of row 277 of Part A of the Annex to Implementing Regulation (EU) No 540/2011, concerning monitoring programmes for contamination by copper, is not sufficient to conclude on the environmental risk assessment.

               (8)

               It is confirmed that the active substance copper compounds is to be deemed to have been approved under Regulation (EC) No 1107/2009. It is, in particular, appropriate to require that the notifier presents to the Commission, the Authority and the Member States a monitoring programme for areas where the contamination of soil and water (including sediments) by copper is a concern or may become one, in order to verify whether further limitations of use are necessary to prevent any unacceptable environmental effect. The results of that monitoring programme should also be presented.

               (9)

               The maximum levels for certain heavy metals, as set in row 277 of Part A of the Annex to Implementing Regulation (EU) No 540/2011, were by mistake set with wrong measurement unit from those set in the respective FAO specifications. The maximum level set in the Annex to that Implementing Regulation should therefore be corrected.

               (10)

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

               (11)

               Member States should be provided with time to amend or withdraw authorisations for plant protection products containing copper compounds.

               (12)

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

               (13)

               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
   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 copper compounds as active substance by 6 September 2015.
   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 6 September 2016 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, 13 February 2015.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

      (2)  Commission Directive 2009/37/EC of 23 April 2009 amending Council Directive 91/414/EEC to include chlormequat, copper compounds, propaquizafop, quizalofop-P, teflubenzuron and zeta-cypermethrin as active substances (OJ L 104, 24.4.2009, p. 23).

      (3)  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).

      (4)  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).

      (5)  Conclusion on the peer review of the pesticide risk assessment of confirmatory data submitted for the active substance Copper (I), copper (II) variants namely copper hydroxide, copper oxychloride, tribasic copper sulfate, copper (I) oxide, Bordeaux mixture. EFSA Journal 2013;11(6):3235, 40 pp. doi:10.2903/j.efsa.2013.3235. Available online: www.efsa.europa.eu/efsajournal.htm

      ANNEX
      In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 277 on the active substance Copper Compounds is replaced by the following:

                     Number

                     Common Name,
                     Identification Numbers

                     IUPAC Name

                     Purity

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘277

                     Copper compounds:

                     1 December 2009

                     31 January 2018

                     PART A
                     Only uses as bactericide and fungicide may be authorised.
                     PART B
                     In assessing applications to authorise plant protection products containing copper for uses other than on tomatoes in greenhouses, 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 copper compounds, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009, shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 —

                                 the specification of the technical material as commercially manufactured which 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,

                                 —

                                 the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate,

                                 —

                                 the protection of water and non-target organisms. In relation to these identified risks risk mitigation measures, such as buffer zones, should be applied where appropriate,

                                 —

                                 the amount of active substance applied and ensure that the authorised amounts, in terms of rates and number of applications, are the minimum necessary to achieve the desired effects and do not cause any unacceptable effect on the environment taking into account background levels of copper at the application site.

                           The notifiers shall present to the Commission, the Authority and the Member States a monitoring programme for vulnerable areas where the contamination of the soil and water (including sediments) by copper is a concern or may become one.
                     That monitoring programme shall be submitted by 31 July 2015. The interim results of such monitoring programme shall be submitted as interim report to the Rapporteur Member State, the Commission and the Authority by 31 December 2016. Final results shall be submitted by 31 December 2017.’

                     Copper hydroxide
                     CAS No 20427-59-2
                     CIPAC No 44.305

                     Copper (II) hydroxide

                     ≥ 573 g/kg

                     Copper oxychloride
                     CAS No 1332-65-6 or 1332-40-7
                     CIPAC No 44.602

                     Dicopper chloride trihydroxide

                     ≥ 550 g/kg

                     Copper oxide
                     CAS No 1317-39-1
                     CIPAC No 44.603

                     Copper oxide

                     ≥ 820 g/kg

                     Bordeaux mixture
                     CAS No 8011-63-0
                     CIPAC No 44.604

                     Not allocated

                     ≥ 245 g/kg

                     Tribasic copper sulphate
                     CAS No 12527-76-3
                     CIPAC No 44.306

                     Not allocated

                     ≥ 490 g/kg
                     The following impurities are of toxicological concern and must not exceed the levels below (expressed in g/g):

                                 Lead max 0,0005 g/g of copper content;

                                 Cadmium max 0,0001 g/g of copper content;

                                 Arsenic max 0,0001 g/g of copper content.


title: Implementing Regulation of the Council (EU) No 363/2010 of 26 April 2010 amending Regulation (EC) No 1001/2008 imposing a definitive anti-dumping duty on imports of certain tube and pipe fittings of iron or steel originating, inter alia , in Malaysia

text:
               29.4.2010

               EN

               Official Journal of the European Union

               L 107/1

         IMPLEMENTING REGULATION OF THE COUNCIL (EU) No 363/2010
   of 26 April 2010
   amending Regulation (EC) No 1001/2008 imposing a definitive anti-dumping duty on imports of certain tube and pipe fittings of iron or steel originating, inter alia, in Malaysia
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1225/2009 of 30 November 2009 on protection against dumped imports from countries not members of the European Community (1) (the basic Regulation), and in particular Article 11(4) thereof,
   Having regard to the proposal submitted by the Commission after consulting the Advisory Committee,
   Whereas:
   1.   PROCEDURE

   1.1.   Existing measures

               (1)

               In October 2008, definitive anti-dumping measures were reimposed by Council Regulation (EC) No 1001/2008 (2) on imports of certain tube and pipe fittings (‘TPFs’ or the ‘product concerned’) originating, inter alia, in Malaysia following an expiry review pursuant to Article 11(2) of the basic Regulation. The anti-dumping duties in force for Malaysia are 59,2 % for Anggerik Laksana Sdn Bhd and 75 % for all other companies.

         1.2.   Request for a review

               (2)

               The Commission has received an application to initiate a ‘new exporter’ review pursuant to Article 11(4) of the basic Regulation. The application was lodged by Pantech Steel Industries Sdn Bhd (the applicant), an exporting producer in Malaysia (the country concerned).

               (3)

               The applicant alleged that it did not export the product concerned to the Union during the period of investigation on which the anti-dumping measures were based, i.e. the period from 1 April 2000 to 31 March 2001 (the original investigation period) and that it is not related to any of the exporting producers of the product concerned which are subject to the anti-dumping measures described in recital 1.

               (4)

               The applicant further alleged that it had entered into an irrevocable contractual obligation to export the product concerned to the Union in the near future.

         1.3.   Initiation of a new exporter review

               (5)

               The Commission examined the prima facie evidence submitted by the applicant and considered it sufficient to justify the initiation of a review in accordance with Article 11(4) of the basic Regulation. After consultation of the Advisory Committee, and after the Union industry concerned had been given the opportunity to comment, the Commission initiated, by Regulation (EC) No 692/2009 (3), a review of Regulation (EC) No 1001/2008 with regard to the applicant.

               (6)

               Pursuant to Regulation (EC) No 692/2009, the anti-dumping duty of 75 % imposed by Regulation (EC) No 1001/2008 was repealed with regard to imports of the product concerned produced and sold for exports to the Union by the applicant. Simultaneously, pursuant to Article 14(5) of the basic Regulation, customs authorities were directed to take appropriate steps to register such imports.

               (7)

               Regulation (EC) No 692/2009 determined that if the investigation showed that the applicant fulfilled the requirements to have an individual duty established, it may be necessary to amend the rate of duty currently applicable to imports of the product concerned from companies not individually mentioned in Article 1 of Regulation (EC) No 1001/2008.

         1.4.   Product concerned

               (8)

               The product under review is tube and pipe fittings (other than cast fittings, flanges and threaded fittings), of iron or steel (not including stainless steel), with a greatest external diameter not exceeding 609,6 mm, of a kind used for butt-welding or other purposes, originating in Malaysia (the product concerned), currently falling within CN codes ex 7307 93 11, ex 7307 93 19, ex 7307 99 30 and ex 7307 99 90.

         1.5.   Parties concerned

               (9)

               The Commission officially advised the Union industry, the applicant and the representatives of the exporting country of the initiation of the review. Interested parties were given the opportunity to make their views known in writing and to be heard.

               (10)

               The Defence Committee of the steel butt-welding fittings industry of the European Union representing the Union industry (the Union industry) made its views know in writing to the Commission services. The Defence Committee challenged the reliability of the basis for the export price. Documents were also provided allegedly showing attempts to circumvent the measures and information was given about the level of price of the product concerned available for EU importers.

               (11)

               The Commission sent an anti-dumping questionnaire to the applicant and its related companies and received a reply within the deadline set for that purpose.

               (12)

               The Commission also sent anti-dumping questionnaires to unrelated importers located in the European Union but no cooperation was obtained.

               (13)

               The Commission sought to verify all the information it deemed necessary for the determination of the new exporter status and dumping, and verification visits were carried out at the premises of the applicant and a related company in Malaysia:

                           —

                           Pantech Steel Industries Sdn Bhd (the applicant),

                           —

                           Pantech Corporation Sdn Bhd (related trading company).

         1.6.   Investigation period

               (14)

               The review investigation period of dumping covered the period from 1 July 2008 to 30 June 2009 (‘review investigation period’ or ‘RIP’).

         2.   RESULTS OF THE INVESTIGATION

   2.1.   New exporter qualification

               (15)

               The investigation confirmed that the company had not exported the product concerned during the original period of investigation and that it had started to export to the European Union after this period. The company entered into an irrevocable contractual obligation to export during the RIP. This took the form of three orders from the same importing group in the EU.

               (16)

               These orders were, after the RIP, completed by export transactions under approximately the same conditions with negligible differences in price and quantities. While the quantities involved were limited, they were nevertheless found sufficient to establish a reliable dumping margin. This is because the levels of prices charged were further supported by other information at the Commission services’ disposal, including export prices of the exporter concerned to third countries, which confirmed the pattern of behaviour found in the transactions under scrutiny.

               (17)

               As concerns the other conditions for the recognition of a new exporter status, the company was able to demonstrate that it did not have any links, direct or indirect, with any of the Malaysian exporting producers subject to the anti-dumping measures in force with regard to the product concerned.

               (18)

               Accordingly, it is confirmed that the company should be considered a ‘new exporter’ in accordance with Article 11(4) of the basic Regulation, and thus an individual margin should be determined for it.

         2.2.   Dumping

               (19)

               The applicant produces the fittings and sells the product concerned domestically and on export markets. The investigation revealed a complex sales organisation on the domestic market involving unrelated distributors and related trading companies, whereby unrelated distributors purchase the product concerned from the producer and then resell it to the related traders that then sell the goods onwards to unrelated customers on the domestic market. De facto, the unrelated distributors act as agents for the applicant.

               (20)

               Based on the above, and taking into account the fact that the sales of the related trading companies can be linked back to the applicant, the prices charged to the final consumer by these related trading companies are considered as the first price in the ordinary course of trade and therefore form the basis for the normal value determination.

               (21)

               In accordance with Article 2(2) of the basic Regulation, domestic sales were considered representative when the total domestic sales volume was at least 5 % of the total export sales volume to the Union. The Commission established that tube and pipe fittings were sold domestically by the applicant in overall representative volumes.

               (22)

               The Commission then identified those product types of tube and pipe fittings sold domestically by the trading companies which were identical or directly comparable to the types sold for export to the European Union.

               (23)

               An examination was also made by the Commission as to whether the sales of tube and pipe fittings sold domestically in representative quantities could be regarded as having been made in the ordinary course of trade pursuant to Article 2(4) of the basic Regulation. This was done by establishing the proportion of profitable domestic sales to independent customers. As it was found that there were sufficient sales in the ordinary course of trade, normal value was based on the actual domestic price.

               (24)

               In the few cases where the type of product concerned was not sold on the domestic market during the RIP, the normal value was constructed by adding to the exporter’s manufacturing costs of the exported types, a reasonable amount for selling, general and administrative expenses (SG&A) and a reasonable profit margin.

               (25)

               The product concerned was exported directly to independent customers in the Union. Therefore, the export price was established in accordance with Article 2(8) of the basic Regulation, i.e. on the basis of export prices actually paid or payable as referred to in recital 16.

               (26)

               The normal value and the export prices were compared on an ex-works basis.

               (27)

               For the purpose of ensuring a fair comparison between normal value and export price, due allowance in the form of adjustments was made for differences affecting price comparability in accordance with Article 2(10) of the basic Regulation. Adjustments for insurance, handling, loading and ancillary expenses, and credit costs were granted in all cases where they were found to be reasonable, accurate and supported by verified evidence.

               (28)

               The applicant claimed that if the Commission would use the normal value based on the domestic sales of the related trading companies, an adjustment for differences in level of trade should be granted between the domestic market and the EU market. It further argued that sales to the EU market were done at distributor level whereas, in the domestic market, the applicant used to sell an important part of the tube and pipe fittings as part of larger consignments in oil and gas project markets where fittings often play an ancillary role only to that of the main pipes, valves and other major components, and that this market was at a different level of trade.

               (29)

               After having analysed the sales conditions on the domestic market and in particular the sales price patterns, the investigation showed that the applicant did not demonstrate, in accordance with Article 2(10) of the basic Regulation, a consistent and distinct difference in functions and prices for the different levels of trade in the domestic market of the exporting country. Therefore no adjustment was taken into account.

               (30)

               In accordance with Article 2(11) of the basic Regulation, and taking into account that there were only three orders at virtually the same point in time during the RIP and that the price of the raw material, which accounts for most of the cost of manufacturing, varied significantly during the RIP, the dumping margin was established on the basis of a comparison on a transaction to transaction basis between the normal value and the export price.

               (31)

               The comparison showed the existence of dumping at a level of 49,9 %, expressed as a percentage of the CIF Union-frontier price.

               (32)

               In addition, the investigation confirmed that the export prices of the applicant to other third countries with important quantities are significantly lower than those to the European Union, suggesting the existence of dumping on third markets.

         3.   AMENDMENT OF THE MEASURES BEING REVIEWED

               (33)

               In the light of the results of the investigation, it is considered that a definitive anti-dumping duty should be imposed at the level of the dumping margin found.

               (34)

               The dumping margin, established for the RIP, of 49,9 % is below the country-wide injury elimination level of 75 % which was established for Malaysia in the original investigation. It is therefore proposed that a duty which is based on the dumping margin of 49,9 % be imposed and that Regulation (EC) No 1001/2008 be accordingly amended.

         4.   RETROACTIVE LEVYING OF THE ANTI-DUMPING DUTY

               (35)

               In the light of the above findings, the anti-dumping duty applicable to the applicant shall be levied retroactively on imports of the product concerned which have been made subject to registration pursuant to Article 3 of Regulation (EC) No 692/2009.

         5.   MONITORING CLAUSE AND POSSIBLE FURTHER REVIEW

               (36)

               It should be noted that the companies concerned have a complex system of distribution which also involves importing the product concerned from other countries under measures. In addition, there is a certain risk of duty avoidance due to the high difference in the duty rates between the different exporting companies inside Malaysia. Therefore, special measures are needed to ensure the proper application of the anti-dumping duties.

               (37)

               These special measures consist of the presentation to the customs authorities of the Member States of a valid commercial invoice which shall conform to the requirements set out in the Annex to this Regulation. Imports not accompanied by such an invoice shall be made subject to the residual anti-dumping duty applicable to all other exporters.

               (38)

               Furthermore, the Council notes that the Commission has informed it that it will invite the company concerned to submit regular reports to the Commission in order to ensure proper follow up of their sales of the product concerned to the Union and the price and other conditions related thereto, as well as information regarding developments in the company’s domestic sales prices. The Council notes that, in particular, if such reports are not submitted, or where such reports disclose that measures may not be adequate to eliminate the effects of injurious dumping, it may be necessary to initiate an interim review in accordance with Article 11(3) of the basic Regulation. The Council also notes that the Commission has the possibility to ex officio initiate an interim review pursuant to Article 11(3) of the basic Regulation, in particular once one year has passed after the entry into force of this Regulation (although a previous review may also be warranted). It is noted that at this point in time, the Commission expects that it will be appropriate to conduct such a review after one year given the circumstances of this case. In this context, it is important to note that the duty established for the company concerned by this Regulation is based on only a limited number of orders.

         6.   DISCLOSURE AND DURATION OF THE MEASURES

               (39)

               The parties concerned were informed of the essential facts and considerations on the basis of which it was intended to impose on imports of tube and pipe fittings from the applicant an amended definitive anti-dumping duty and to levy this duty retroactively on imports made subject to registration. Their comments were considered and taken into account, where appropriate.

               (40)

               This review does not affect the date on which the measures imposed by Regulation (EC) No 1001/2008 will expire pursuant to Article 11(2) of the basic Regulation,

         HAS ADOPTED THIS REGULATION:
   Article 1
   1.   In Article 1(2) of Regulation (EC) No 1001/2008, the following shall be inserted into the table under producers in Malaysia:

                  ‘Country

                  Company

                  Rate of duty (%)

                  TARIC additional code

                  Malaysia

                  Pantech Steel Industries Sdn Bhd

                  49,9

                  A961’

   2.   The duty hereby imposed shall also be levied retroactively on imports of the product concerned which have been registered pursuant to Article 3 of Regulation (EC) No 692/2009.
   The customs authorities are hereby directed to cease the registration of imports of the product concerned originating in Malaysia produced by Pantech Steel Industries Sdn Bhd.
   3.   In Article 1 of Regulation (EC) No 1001/2008 the following paragraph shall be added:

      ‘3.   The application of the individual duty rates specified for Pantech Steel Industries Sdn Bhd shall be conditional upon presentation to the customs authorities of the Member States of a valid commercial invoice, which shall conform to the requirements set out in the Annex. If no such invoice is presented, the duty rate applicable to all other companies shall apply.’

   4.   The addition of the above paragraph in Regulation (EC) No 1001/2008 implies that Article 1(3) of that Regulation is to be renumbered as Article 1(4).
   5.   In Regulation (EC) No 1001/2008, the following Annex shall be added:

         ‘ANNEX
         A declaration signed by an official of the entity issuing the commercial invoice, in the following format, must appear on the valid commercial invoice referred to in Article 1(3):

                     1.

                     The name and function of the official of the entity issuing the commercial invoice.

                     2.

                     The following declaration: “I, the undersigned, certify that the (volume) of [product concerned] sold for export to the European Union covered by this invoice was manufactured by (company name and address) (TARIC additional code) in (country concerned). I declare that the information provided in this invoice is complete and correct and that the invoiced price is final and will not be compensated, in part or in whole, via any practice.

               Date and signature”.’.

   6.   Unless otherwise specified, the provisions in force concerning customs duties shall apply.
   Article 2
   This Regulation shall enter into force on the day following 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 Luxembourg, 26 April 2010.

            For the Council

            The President

         C. ASHTON

      (1)  OJ L 343, 22.12.2009, p. 51.

      (2)  OJ L 275, 16.10.2008, p. 18.

      (3)  OJ L 199, 31.7.2009, p. 9.


title: Commission Implementing Regulation (EU) No 921/2014 of 25 August 2014 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance tebuconazole  Text with EEA relevance

text:
               26.8.2014

               EN

               Official Journal of the European Union

               L 252/3

         COMMISSION IMPLEMENTING REGULATION (EU) No 921/2014
   of 25 August 2014
   amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance tebuconazole
   (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)

               Commission Directive 2008/125/EC (2) included tebuconazole as active substance in Annex I to Council Directive 91/414/EEC (3) for use as a fungicide, under the condition that the Member States concerned ensure that the notifiers at whose request tebuconazole was included in that Annex provides further confirmatory information in the form of studies on the risk for birds and mammals.

               (2)

               Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

               (3)

               On 8 April 2010 one of the notifiers at whose request tebuconazole was included in Annex I to Directive 91/414/EEC, submitted an application for an amendment to the conditions of approval of the active substance tebuconazole to allow uses as a plant growth regulator to be authorised without restriction. That application was accompanied by information relating to the requested additional supported use as plant growth regulator in oilseed rape. It was submitted to Denmark, which had been designated rapporteur Member State by Commission Regulation No. 1490/2002 (5).

               (4)

               Denmark assessed the information submitted by the notifier. It submitted its assessment, in the form of an addendum to the draft assessment report, to the other Member States, the Commission and the European Food Safety Authority, hereinafter ‘the Authority’, on 23 July 2012.

               (5)

               The Commission consulted the Authority which presented its opinion on the risk assessment of tebuconazole on 9 December 2013 (6). The draft assessment report, the addendum and the opinion 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 tebuconazole.

               (6)

               The Commission invited the notifier to submit its comments on the review report for tebuconazole.

               (7)

               The Commission has come to the conclusion that allowing uses as a plant growth regulator to be authorised without restriction does not cause any risks in addition to those already taken into account in the approval of tebuconazole and in the Commission review report for that substance.

               (8)

               It is appropriate to extend the approval of tebuconazole to cover uses as a plant growth regulator without restriction. However, in order to take into account the remaining uncertainty on the potential for groundwater exposure of the metabolite 1,2,4-triazole for the representative spray uses on cereals, as a barley seed treatment and on grapes, Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil or climatic conditions, in particular as regards the occurrence in groundwater of the metabolite 1,2,4-triazole.

               (9)

               In January 2014, Denmark finalized the evaluation of the confirmatory information as regards the risk to birds and mammals. The Standing Committee on Plants, Animals, Food and Feed agrees that, on the basis of the current outcome, the risk to birds and mammals is acceptable. Therefore, the conclusions of the original risk assessment are not substantially affected by the evaluation of the submitted confirmatory data. No further review by the Authority has been considered necessary.

               (10)

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

               (11)

               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
   Amendment to Regulation (EC) 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
   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, 25 August 2014.

            For the Commission

            The President

         José Manuel BARROSO

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

      (2)  Commission Directive 2008/125/EC of 19 December 2008 amending Council Directive 91/414/EEC to include aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole and triadimenol as active substances (OJ L 344, 20.12.2008, p. 78).

      (3)  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).

      (4)  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).

      (5)  Commission Regulation (EC) No 1490/2002 of 14 August 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 amending Regulation (EC) No 451/2000 (OJ L 224, 21.8.2002, p. 23).

      (6)  EFSA (European Food Safety Authority), 2013. Conclusion on the peer review of the pesticide risk assessment of the active substance tebuconazole. EFSA Journal 2014;12(1):3485, 98 pp. doi:10.2903/j.efsa.2014.3485.

      ANNEX
      The column ‘Specific provisions’ of row 268, tebuconazole, of Part A of the Annex to Implementing Regulation (EU) No 540/2011, is replaced by the following:

         ‘PART A
         Only uses as fungicide and plant growth regulator 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 tebuconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to:

                     —

                     the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;

                     —

                     the dietary exposure of consumers to the tebuconazole (triazole) metabolites;

                     —

                     the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil or climatic conditions, in particular as regards the occurrence in groundwater of the metabolite 1,2,4-triazole;

                     —

                     the protection of granivorous birds and mammals and herbivorous mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;

                     —

                     the protection of aquatic organisms and must ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate.

               The Member States concerned shall ensure that the notifier submits to the Commission further information addressing the potential endocrine disrupting properties of tebuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.’


title: Commission Implementing Regulation (EU) No 359/2012 of 25 April 2012 approving the active substance metam, 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:
               26.4.2012

               EN

               Official Journal of the European Union

               L 114/1

         COMMISSION IMPLEMENTING REGULATION (EU) No 359/2012
   of 25 April 2012
   approving the active substance metam, 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)(c) 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 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). Metam 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 lists of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. These lists included metam. By Council Decision 2009/562/EC of 13 July 2009 concerning the non-inclusion of metam in Annex I to Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance (6) it was decided not to include metam in Annex I to Directive 91/414/EEC.

               (3)

               Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier (hereinafter ‘the applicant’) submitted a new application requesting the accelerated procedure to be applied, as provided for in Articles 14 to 19 of Regulation (EC) No 33/2008.

               (4)

               The application was submitted to Belgium, 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 those that were the subject of Decision 2009/562/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.

               (5)

               Belgium 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 31 August 2010.

               (6)

               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 metam to the Commission on 8 August 2011 (7). 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 9 March 2012 in the format of the Commission review report for metam.

               (7)

               The additional report by the rapporteur Member State and the new conclusions by the Authority concentrate on the concerns that led to the non-inclusion. Those concerns were in particular that it was not possible to demonstrate the acceptability of consumer exposure and lack of data with respect to the behaviour in the environment of the impurity N,N-dimethylthiourea (DMTU).

               (8)

               The new information submitted by the applicant shows that the exposure of consumers may be considered acceptable and the behaviour of DMTU in the environment will not result in unacceptable effects.

               (9)

               Consequently, the additional information provided by the applicant permits to eliminate the specific concerns that led to the non-inclusion.

               (10)

               It has appeared from the various examinations made that plant protection products containing metam 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 metam in accordance with Regulation (EC) No 1107/2009.

               (11)

               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.

               (12)

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

               (13)

               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.

               (14)

               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 after approval to review authorisations of plant protection products containing metam which have been maintained for certain uses in accordance with Article 3 of Decision 2009/562/EC. For the calculation of that period that provision is to be taken into account. Member States should, as appropriate, vary, replace or withdraw existing authorisations.

               (15)

               For plant protection products containing metam, where Member States grant any period of grace in accordance with Article 46 of Regulation (EC) No 1107/2009, Article 4 of Decision 2009/562/EC should be taken into account for the calculation of that period. Hence, such a period of grace should expire at the latest by 31 December 2014.

               (16)

               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 (8) 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 to the Regulations approving active substances.

               (17)

               In accordance with Article 13(4) of Regulation (EC) No 1107/2009 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 (9) should be amended accordingly.

               (18)

               In the interest of clarity, Decision 2009/562/EC should be repealed.

               (19)

               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 metam, 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 metam as an active substance by 31 December 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 metam 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 June 2012 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 metam as the only active substance, where necessary, amend or withdraw the authorisation by 30 June 2016;

               (b)

               in the case of a product containing metam 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 substances, whichever is the latest.

         Article 3
   Grace period
   Where Member States withdraw or amend an existing authorisation in accordance with Article 2(1), 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 by 31 December 2014 at the latest.
   Article 4
   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 5
   Repeal
   Decision 2009/562/EC is repealed.
   Article 6
   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 July 2012.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 25 April 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 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 196, 28.7.2009, p. 22.

      (7)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance metam. EFSA Journal 2011;9(9):2334.[97 pp.] doi:10.2903/j.efsa.2011.2334. Available online: www.efsa.europa.eu/efsajournal.htm

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

      (9)  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

                  Metam
                  CAS No 144-54-7
                  CIPAC No 20

                  Methyldithiocarbamic acid

                  ≥ 965 g/kg
                  Expressed as metam-sodium on a dry weight basis
                  ≥ 990 g/kg
                  Expressed as metam-potassium on a dry weight basis
                  Relevant impurities:

                              methylisothiocyanate (MITC)

                                          —

                                          max. 12 g/kg on dry weight basis (metam-sodium),

                                          —

                                          max. 0,42 g/kg on dry weight basis (metam-potassium).

                                 N,N’-dimethylthiourea (DMTU)

                                          —

                                          max. 23 g/kg on a dry weight basis (metam-sodium),

                                          —

                                          max. 6 g/kg on a dry weight basis (metam-potassium).

                  1 July 2012

                  30 June 2022

                  PART A
                  Only uses as nematicide, fungicide, herbicide and insecticide may be authorised for application as soil fumigant prior to planting, limited to one application every third year on the same field.
                  The application may be authorised in open field by soil injection or drip irrigation, and in greenhouse by drip irrigation only. The use of gas-tight plastic film for drip irrigation shall be prescribed.
                  The maximum application rate shall be 153 kg/ha (corresponding to 86,3 kg/ha of MITC) in case of open field applications.
                  Authorisations shall be limited to professional users.
                  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 metam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012, shall be taken into account.
                  In this overall assessment Member States:

                              (a)

                              shall pay particular attention to the protection of operators and shall ensure that the conditions of use include risk mitigation measures such as application of adequate personal protective equipment and a limitation in the daily work rate;

                              (b)

                              shall pay particular attention to the protection of workers and shall ensure that the conditions of use include risk mitigation measures, such as use of adequate personal protective equipment, re-entry period and limitation in the daily work rate;

                              (c)

                              shall pay particular attention to the protection of bystanders and residents and shall ensure that the conditions of use include risk mitigation measures, such as an appropriate buffer zone during and until 24 hours after the application from the perimeter of the application area to any occupied residences and areas used by the general public with obligation to use warning signs and ground markers;

                              (d)

                              shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions and shall ensure that the conditions of use include risk mitigation measures, such as appropriate buffer zone;

                              (e)

                              shall pay particular attention to the risk to non-target organisms and shall ensure that conditions of use shall include risk mitigation measures, where appropriate.

                        The applicant shall submit confirmatory information on methyl isothiocyanate as regards:

                              (1)

                              the assessment of the long-range atmospheric transport potential and related environmental risks;

                              (2)

                              the potential groundwater contamination.

                        The applicant shall submit to the Commission, the Member States and the Authority such information by 31 May 2014.

         (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 No (EU) 540/2011, the following entry is added:

                     No

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘22

                     Metam
                     CAS No 144-54-7
                     CIPAC No 20

                     Methyldithiocarbamic acid

                     ≥ 965 g/kg
                     Expressed as metam-sodium on a dry weight basis
                     ≥ 990 g/kg
                     Expressed as metam-potassium on a dry weight basis
                     Relevant impurities:

                                 methylisothiocyanate (MITC)

                                             —

                                             max. 12 g/kg on dry weight basis (metam-sodium),

                                             —

                                             max. 0,42 g/kg on dry weight basis (metam-potassium).

                                    N,N’-dimethylthiourea (DMTU)

                                             —

                                             max. 23 g/kg on a dry weight basis (metam-sodium),

                                             —

                                             max. 6 g/kg on a dry weight basis (metam-potassium).

                     1 July 2012

                     30 June 2022

                     PART A
                     Only uses as nematicide, fungicide, herbicide and insecticide may be authorised for application as soil fumigant prior to planting, limited to one application every third year on the same field.
                     The application may be authorised in open field by soil injection or drip irrigation, and in greenhouse by drip irrigation only. The use of gas-tight plastic film for drip irrigation shall be prescribed.
                     The maximum application rate shall be 153 kg/ha (corresponding to 86,3 kg/ha of MITC) in case of open field applications.
                     Authorisations shall be limited to professional users.
                     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 metam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012, shall be taken into account.
                     In this overall assessment Member States:

                                 (a)

                                 shall pay particular attention to the protection of operators and shall ensure that the conditions of use include risk mitigation measures such as application of adequate personal protective equipment and a limitation in the daily work rate;

                                 (b)

                                 shall pay particular attention to the protection of workers and shall ensure that the conditions of use include risk mitigation measures, such as use of adequate personal protective equipment, re-entry period and limitation in the daily work rate;

                                 (c)

                                 shall pay particular attention to the protection of bystanders and residents and shall ensure that the conditions of use include risk mitigation measures, such as an appropriate buffer zone during and until 24 hours after the application from the perimeter of the application area to any occupied residences and areas used by the general public with obligation to use warning signs and ground markers;

                                 (d)

                                 shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions and shall ensure that the conditions of use include risk mitigation measures, such as appropriate buffer zone;

                                 (e)

                                 shall pay particular attention to the risk to non-target organisms and shall ensure that conditions of use shall include risk mitigation measures, where appropriate.

                           The applicant shall submit confirmatory information on methyl isothiocyanate as regards:

                                 (1)

                                 the assessment of the long-range atmospheric transport potential and related environmental risks;

                                 (2)

                                 the potential groundwater contamination.

                           The applicant shall submit to the Commission, the Member States and the Authority such information by 31 May 2014.’

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


title: Commission Implementing Regulation (EU) No 504/2014 of 15 May 2014 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance plant oils/citronella oil  Text with EEA relevance

text:
               16.5.2014

               EN

               Official Journal of the European Union

               L 145/28

         COMMISSION IMPLEMENTING REGULATION (EU) No 504/2014
   of 15 May 2014
   amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance plant oils/citronella 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) and Article 78(2) thereof,
   Whereas:

               (1)

               The active substance plant oils/citronella oil 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 plant oils/citronella oil (6) on 16 December 2011. The Authority communicated its view on plant oils/citronella oil to the notifier. The Commission invited the notifier to submit comments on the draft review report for plant oils/citronella oil. 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 the draft review report was finalised on 3 October 2013 in the format of the Commission review report for plant oils/citronella oil.

               (3)

               It is confirmed that the active substance plant oils/citronella oil 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 plant oils/citronella oil.

               (7)

               For plant protection products containing plant oils/citronella oil, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, this period should expire at the latest eighteen months after the date of entry into force of the 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 plant oils/citronella oil as active substance by 5 December 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 5 December 2015 at the latest.
   Article 4
   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, 15 May 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 plant oils/citronella oil. EFSA Journal 2012; 10(2):2518. [42 pp.] doi:10.2903/j.efsa.2012.2518 Available online: www.efsa.europa.eu/efsajournal

      ANNEX
      In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 240 on the active substance plant oils/citronella oil is replaced by the following:

                     Number

                     Common Name,
                     Identification Numbers

                     IUPAC Name

                     Purity

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘240

                     Plant oils/citronella oil
                     CAS No 8000-29-1
                     CIPAC No 905

                     Citronella Oil is a complex mixture of chemical substances.
                     The main components are:

                                 Citronellal (3,7-dimethyl-6-octenal).

                                 Geraniol ((E)-3,7-dimethyl-2,6-octadien-1-ol).

                                 Citronellol (3,7-dimethyl-6-octan-2-ol).

                                 Geranyl acetate (3,7-dimethyl-6-octen-1yl acetate).

                     The sum of the following impurities must not exceed 0,1 % of technical material: methyl eugenol and methyl-isoeugenol.

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as herbicide 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 citronella oil (SANCO/2621/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.
                     In this overall assessment Member States shall pay particular attention to:

                                 —

                                 the protection of operators, workers, bystanders and residents, 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;

                                 —

                                 the risk to non-target organisms.

                           The notifier shall submit confirmatory information as regards:

                                 (a)

                                 the technical specification;

                                 (b)

                                 data comparing natural background exposure situations of plant oils/citronella oil and methyl eugenol and methyl isoeugenol in relation to exposure from the use of plant oils/citronella oil as a plant protection product. This data shall cover human exposure as well as exposure of non-target organisms;

                                 (c)

                                 the groundwater exposure assessment for potential metabolites of plant oils/citronella oil, in particular for methyl eugenol and methyl isoeugenol.

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


title: Commission Implementing Regulation (EU) No 1192/2013 of 22 November 2013 approving the active substance tembotrione, 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:
               23.11.2013

               EN

               Official Journal of the European Union

               L 314/6

         COMMISSION IMPLEMENTING REGULATION (EU) No 1192/2013
   of 22 November 2013
   approving the active substance tembotrione, 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 Articles 13(2) and 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 tembotrione the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2006/586/EC (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC, Austria received on 25 November 2005 an application from Bayer CropScience AG for the inclusion of the active substance tembotrione in Annex I to Directive 91/414/EEC. Decision 2006/586/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 7 February 2007. In accordance with Article 11(6) of Commission Regulation (EU) No 188/2011 (4) additional information was requested from the applicant on 14 May 2012. The evaluation of the additional data by Austria was submitted in the format of an updated draft assessment report in September 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 tembotrione (5) on 6 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 tembotrione.

               (5)

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

               (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 tembotrione. 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 tembotrione, 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 tembotrione 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 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 tembotrione 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 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 tembotrione 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 tembotrione 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 2006/586/EC of 25 August 2006 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of chromafenozide, halosulfuron, tembotrione, valiphenal and Zucchini yellow mosaic virus — weak strain in Annex I to Council Directive 91/414/EEC (OJ L 236, 31.8.2006, p. 31).

      (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):3131. 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

                  Tembotrione
                  CAS No 335104-84-2
                  CIPAC No 790

                  2-{2-chloro-4-mesyl-3-[(2,2,2-trifluoroethoxy)methyl]benzoyl}cyclohexane-1,3-dione

                  ≥ 945 g/kg
                  The following relevant impurities must not exceed a certain threshold in the technical material:
                  Toluene: ≤ 10 g/kg
                  HCN: ≤ 1 g/kg

                  1 May 2014

                  30 April 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 tembotrione, 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)

                              the risk to aquatic 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

                     ‘59

                     Tembotrione
                     CAS No 335104-84-2
                     CIPAC No 790

                     2-{2-chloro-4-mesyl-3-[(2,2,2-trifluoroethoxy)methyl]benzoyl}cyclohexane-1,3-dione

                     ≥ 945 g/kg
                     The following relevant impurities must not exceed a certain threshold in the technical material:
                     Toluene: ≤ 10 g/kg
                     HCN: ≤ 1 g/kg

                     1 May 2014

                     30 April 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 tembotrione, 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)

                                 the risk to aquatic 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.