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32002L0036

Commission Directive 2002/36/EC of 29 April 2002 amending certain Annexes to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community

Official Journal L 116 , 03/05/2002 P. 0016 - 0026

Commission Directive 2002/36/ECof 29 April 2002amending certain Annexes to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the CommunityTHE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community(1), as last amended by Commission Directive 2002/28/EC(2), and in particular the second paragraph, subparagraphs (c) and (d) of Article 14, thereof,Whereas:(1) Measures should be taken to protect the Community against Anisogramma anomala (Peck) E. Müller, Anoplophora glabripennis (Motschulsky) and Naupactus leucoloma Boheman, harmful organisms which have not hitherto been known to occur in the Community.(2) The current provisions against Liriomyza bryoniae (Kaltenbach) should be modified by restricting them to protected zones in Ireland and the United Kingdom (North Ireland) where it has been determined that this organism is not present.(3) The list of host plants of Liriomyza huidobrensis (Blanchard) and Liriomyza trifolii (Burgess) should be modified to take into account of the updated information on the relationship between these harmful organisms and their host plants.(4) Due to continued interceptions of Bemisia tabaci Genn., Liriomyza sativae (Blanchard), Amauromyza maculosa (Malloch), Liriomyza huidobrensis (Blanchard), Liriomyza trifolii (Burgess) and Thrips palmi Karny on commodities, the current provisions on protective measures against the introduction into and spread within the Community, with a view to ensuring more effective protection, should be improved.(5) These improved protective measures should include the use of a plant passport for plants or plant products originating in the Community and a phytosanitary certificate for plants or plant products originating in third countries.(6) The current provisions against beet necrotic yellow vein virus should be modified in order to reflect the conclusions of a Commission Working Group having assessed the phytosanitary risk associated with this harmful organism in the relevant protected zones recognised in the Community.(7) The current provisions against Tilletia indica Mitra should be modified to take into account of the updated information on the presence of this harmful organism in South Africa.(8) The incorrect listing of Malta and Cyprus as non-European countries should be rectified in Annex IV, Part A, Section I, point 34, and Annex V, Part B, Section I, point 7(b), to Directive 2000/29/EC.(9) The amendments are in accordance with the requests of the Member States concerned.(10) Therefore the relevant annexes to Directive 2000/29/EC should be amending accordingly.(11) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,HAS ADOPTED THIS DIRECTIVE:Article 1Annexes I, II, IV and V to Directive 2000/29/EC are hereby amended as indicated in the Annex to this Directive.Article 21. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive on 1 April 2003. They shall forthwith inform the Commission thereof.When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.2. The Member States shall immediately communicate to the Commission the main provisions of domestic law which they adopt in the field covered by this Directive. The Commission shall inform the other Member States thereof.Article 3This Directive shall enter into force on the day following its publication in the Official Journal of the European Communities.Done at Brussels, 29 April 2002.For the CommissionDavid ByrneMember of the Commission(1) OJ L 169, 10.7.2000, p. 1.(2) OJ L 77, 20.3.2002, p. 23.ANNEX1. In Annex I, Part A, Section I(a), a new point is added after point 4: "4.1. Anoplophora glabripennis (Motschulsky)"2. In Annex I, Part A, Section I(a), a new point is added after point 16: "16.1. Naupactus leucoloma Boheman"3. In Annex I, Part A, Section II(a), points 4, 5 and 6 are deleted.4. In Annex I, Part B(a), a new point is added after point 3: >TABLE>5. In Annex II, Part A, Section I(c), the following point is added after point 1: >TABLE>6. In Annex II, Part A, Section II(a), the following points are added after point 7: >TABLE>7. In Annex IV, Part A, Section I, a new point is added after point 11.2: >TABLE>8. In Annex IV, Part A, Section I, points 32.1, 32.2 and 32.3 are replaced by the following: >TABLE>9. In Annex IV, Part A, Section I, point 34, the text in the left-hand column is replaced by the following: >TABLE>10. In Annex IV, Part A, Section I, points 36.1 and 36.2 are replaced by the following: >TABLE>11. In Annex IV, Part A, Section I, point 40, the text in the right hand column is replaced by the following: >TABLE>12. In Annex IV, Part A, Section I, point 45 is replaced by the following: >TABLE>13. In Annex IV, Part A, Section I, point 45.1 is renumbered as 45.3.14. In Annex IV, Part A, Section I, point 46, the reference to Annex IV(A)(I)(45.2) and (45.3) in the right hand column is added.15. In Annex IV, Part A, Section I, points 53 and 54, "South Africa" is inserted after "Pakistan" in the left hand column.16. In Annex IV, Part A, Section II, point 23 is replaced by the following: >TABLE>17. In Annex IV, Part B, point 20.2 is replaced by the following: >TABLE>18. In Annex IV, Part B, point 22 is replaced by the following: >TABLE>19. In Annex IV, Part B, point 24 is replaced by the following: >TABLE>20. In Annex IV, Part B, point 25.1 is deleted.21. In Annex IV, Part B, point 25.2 is replaced by the following: >TABLE>22. In Annex IV, Part B, point 26 is replaced by the following: >TABLE>23. In Annex IV, Part B, point 30, the text in the central column is replaced by the following: "(a) The machinery shall be cleaned and free from soil and plant debris when brought in on places of production where beets are grown,or(b) the machinery shall come from an area where BNYVV is known not to occur"24. In Annex V, Part A, Section I, point 2.1, the following is added: "and other plants of herbaceous species, other than plants of the family Gramineae, intended for planting, and other than bulbs, corms, rhizomes, seeds and tubers"25. In Annex V, Part A, Section II, point 1.6 is replaced by the following: "1.6. Plants of Beta vulgaris L., intended for industrial processing"26. In Annex V, Part A, Section II, point 1.7 is replaced by the following: "1.7. Soil from beet and unsterilised waste from beet (Beta vulgaris L.)"27. In Annex V, Part A, Section II, point 2.1 is replaced by the following: "2.1. Plants of Begonia L., intended for planting, other than corms, seeds, tubers, and plants of Euphorbia pulcherrima Willd., Ficus L. and Hibiscus L., intended for planting, other than seeds"28. In Annex V, Part B, Section I, point 2 is replaced by the following: "- Castanea Mill., Dendranthema (DC) Des. Moul., Dianthus L., Gypsophila L., Pelargonium l'Herit. ex Ait, Phoenix spp., Populus L., Quercus L., Solidago L. and cut flowers of Orchidaceae,- conifers (Coniferales),- Acer saccharum Marsh., originating in North American countries,- Prunus L., originating in non-European countries,- cut flowers of Aster spp., Eryngium L., Hypericum L., Lisianthus L., Rosa L. and Trachelium L., originating in non-European countries,- leafy vegetables of Apium graveolens L. and Ocimum L."29. In Annex V, Part B, Section I, point 3, in the first indent, the following is added: "Momordica L. and Solanum melongena L."30. In Annex V, Part B, Section I, point 7(b), the text is replaced by the following: "Soil and growing medium, attached to or associated with plants, consisting in whole or in part of material specified in (a) or consisting in part of any solid inorganic substance, intended to sustain the vitality of the plants, originating in:- Cyprus, Malta, Turkey,- Belarus, Estonia, Georgia, Latvia, Lithuania, Moldova, Russia, Ukraine,- non-European countries, other than Algeria, Egypt, Israel, Libya, Morocco, Tunisia"31. In Annex V, Part B, Section II, point 1 is replaced by the following: "1. Plants of Beta vulgaris L., intended for industrial processing"32. In Annex V, Part B, Section II, point 2 is replaced by the following: "2. Soil from beet and unsterilised waste from beet (Beta vulgaris L.)"


title: Commission Directive 2010/87/EU of 3 December 2010 amending Council Directive 91/414/EEC to include fenbuconazole as active substance and amending Decision 2008/934/EC  Text with EEA relevance

text:
               4.12.2010

               EN

               Official Journal of the European Union

               L 318/32

         COMMISSION DIRECTIVE 2010/87/EU
   of 3 December 2010
   amending Council Directive 91/414/EEC to include fenbuconazole as active substance and amending Decision 2008/934/EC
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

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

               (2)

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

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

               (4)

               The application was submitted to the United Kingdom, which had been designated rapporteur Member State by Regulation (EC) No 451/2000. The time period for the accelerated procedure was respected. The specification of the active substance and the supported uses are the same as were the subject of Decision 2008/934/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.

               (5)

               The United Kingdom 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 20 July 2009. The Authority communicated the additional report to the other Member States and the applicant for comments and forwarded the comments it had received to the Commission. In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on fenbuconazole to the Commission on 18 March 2010 (6). The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 28 October 2010 in the format of the Commission review report for fenbuconazole.

               (6)

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

               (7)

               Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore, it is appropriate to require that the applicant submit confirmatory data on residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin. To further refine the assessment of potential endocrine disrupting properties, it is appropriate to require that fenbuconazole be subjected to further testing as soon as OECD test guidelines on endocrine disruption, or, alternatively, Community agreed test guidelines exist.

               (8)

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

               (9)

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

               (10)

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

               (11)

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

               (12)

               Commission Decision 2008/934/EC of 5 December 2008 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances provides for the non-inclusion of fenbuconazole and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning fenbuconazole in the Annex to that Decision.

               (13)

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

               (14)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   The line concerning fenbuconazole in the Annex to Decision 2008/934/EC is deleted.
   Article 3
   Member States shall adopt and publish by 31 October 2011 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 November 2011.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 4
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing fenbuconazole as an active substance by 1 November 2011.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to fenbuconazole are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing fenbuconazole as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 30 April 2011 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning fenbuconazole. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
   Following that determination Member States shall:

               (a)

               in the case of a product containing fenbuconazole as the only active substance, where necessary, amend or withdraw the authorisation by 30 April 2015 at the latest; or

               (b)

               in the case of a product containing fenbuconazole as one of several active substances, where necessary, amend or withdraw the authorisation by 30 April 2015 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

         Article 5
   This Directive shall enter into force on 1 May 2011.
   Article 6
   This Directive is addressed to the Member States.

      Done at Brussels, 3 December 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 55, 29.2.2000, p. 25.

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

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

      (5)  OJ L 15, 18.1.2008, p. 5.

      (6)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance fenbuconazole. EFSA Journal 2010; 8(4):1558. [67pp].doi:10.2903/j.efsa.2010.1558. Available online: www.efsa.europa.eu

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

      ANNEX
      The following entry shall be added at the end of the table in Annex I to Directive 91/414/EC:

                     No

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘320

                     Fenbuconazole
                     CAS No: 114369-43-6
                     CIPAC No: 694

                     (R,S) 4-(4-chlorophenyl)-2-phenyl-2-(1H-1,2,4-triazol-1-ylmethyl)butyronitrile

                     ≥ 965 g/kg

                     1 May 2011

                     30 April 2021

                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on fenbuconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 —

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

                                 —

                                 the dietary exposure of consumers to the residues of triazole derivative metabolites (TDMs),

                                 —

                                 the risk to aquatic organisms and mammals.

                           Conditions of use shall include risk mitigation measures, where appropriate.
                     The Member States concerned shall request the submission of confirmatory data on residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin.
                     They shall ensure that the applicant provides such studies to the Commission by 30 April 2013.
                     The Member States concerned shall ensure that the applicant submits to the Commission further information addressing the potential endocrine disrupting properties of fenbuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.’

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


title: Commission Directive 2010/77/EU of 10 November 2010 amending Council Directive 91/414/EEC as regards the expiry dates for inclusion in Annex I of certain active substances  Text with EEA relevance

text:
               11.11.2010

               EN

               Official Journal of the European Union

               L 293/48

         COMMISSION DIRECTIVE 2010/77/EU
   of 10 November 2010
   amending Council Directive 91/414/EEC as regards the expiry dates for inclusion in Annex I of certain active substances
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               The inclusions in Annex I to Directive 91/414/EEC of the active substances listed in the Annex to this Directive expire between 31 May 2011 and 31 December 2012.

               (2)

               Article 5(5) of Directive 91/414/EEC provides that the inclusion of an active substance can be renewed, upon request, provided an application is made at the latest two years before the inclusion period is due to lapse. The Commission has received requests regarding renewals of inclusions for all the substances referred to in recital 1.

               (3)

               Detailed rules will be needed concerning the submission and evaluation of further information necessary for the renewal of Annex I inclusion. Therefore, it is justified to renew the inclusion of the active substances referred to in recital 1 for a period necessary to enable the applicants to prepare their applications and to enable the Commission to evaluate and decide upon such applications.

               (4)

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

               (5)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   Member States shall adopt and publish, by 31 March 2011 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 April 2011.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 3
   Entry into force
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   This Directive is addressed to the Member States.

      Done at Brussels, 10 November 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

      ANNEX
      Annex I to Directive 91/414/EEC is amended as follows:

                  (1)

                  Row 7 is replaced by the following:

                              No

                              Common Name, Identification Numbers

                              IUPAC Name

                              Purity (1)

                              Entry into force

                              Expiration of inclusion

                              Specific provisions

                              ‘7

                              Metsulfuron methyl
                              CAS No 74223-64-6
                              EEC No 441

                              Methyl 2-(4-methoxy-6-methyl-1,3,5,-triazin-2-ylcarbamoylsulfamoyl) benzoate

                              960 g/kg

                              1 July 2001

                              31 December 2015

                              Only uses as herbicide may be authorised.
                              In their decision making according to the Uniform Principles Member States

                                          —

                                          must pay particular attention to the protection of groundwater;

                                          —

                                          must pay particular attention to the impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

                                    Date of Standing Committee on Plant Health at which the review report was finalised: 16 June 2000.’

                  (2)

                  Rows 9 to 28 are replaced by the following:

                              No

                              Common Name, Identification Numbers

                              IUPAC Name

                              Purity (2)

                              Entry into force

                              Expiration of inclusion

                              Specific provisions

                              ‘9

                              Triasulfuron
                              CAS No 82097-50-5
                              CIPAC No 480

                              1-[2-(2-chloroethoxy)phenylsulfonyl] -3 - (4-methoxy-6-methyl-1,3,5-triazin-2-yl)urea

                              940 g/kg

                              1 August 2001

                              31 December 2015

                              Only uses as herbicide may be authorised.
                              In their decision making according to the Uniform Principles Member States:

                                          —

                                          must pay particular attention to the protection of groundwater;

                                          —

                                          must pay particular attention to the impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

                                    Date of Standing Committee on Plant Health at which the review report was finalised: 13 July 2000.

                              10

                              Esfenvalerate
                              CAS No 66230-04-4
                              CIPAC No 481

                              (S)-α-Cyano-3-phenoxybenzyl-(S)-2-(4-chlorophenyl)-3- methylbutyrate

                              830 g/kg

                              1 August 2001

                              31 December 2015

                              Only uses as insecticide may be authorised.
                              In their decision making according to the Uniform Principles Member States:

                                          —

                                          must pay particular attention to the potential impact on aquatic organisms and non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

                                    Date of Standing Committee on Plant Health at which the review report was finalised: 13 July 2000.

                              11

                              Bentazone
                              CAS No 25057-89-0
                              CIPAC No 366

                              3-isopropyl-(1H)-2,1,3-benzothiadiazin-4-(3H)-one-2,2-dioxide

                              960 g/kg

                              1 August 2001

                              31 December 2015

                              Only uses as herbicide may be authorised.
                              In their decision making according to the Uniform Principles Member States must pay particular attention to the protection of groundwater.
                              Date of Standing Committee on Plant Health at which the review report was finalised: 13 July 2000.

                              12

                              Lambda-cyhalothrin
                              CAS No 91465-08-6
                              CIPAC No 463

                              A 1:1 mixture of:

                                          (S)-α-cyano-3-phenoxybenzyl (Z)-(1R,3R)-3-(2-chloro-3,3,3-trifluoropropenyl)-2,2-dimethylcyclopropanecarboxylate,
                                          and

                                          (R)-α-cyano-3-phenoxybenzyl (Z)-(1S,3S)-3-(2-chloro-3,3,3-trifluoropropenyl)-2,2-dimethylcyclopropanecarboxylate

                              810 g/kg

                              1 January 2002

                              31 December 2015

                              Only uses as insecticide may be authorised.
                              In their decision making according to the Uniform Principles Member States:

                                          —

                                          must pay particular attention to operator safety;

                                          —

                                          must pay particular attention to the potential impact on aquatic organisms and non-target arthropods including bees and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;

                                          —

                                          must pay particular attention to the residues in food and especially the acute effects thereof.

                                    Date of Standing Committee on Plant Health at which the review report was finalised: 19 October 2000.

                              13

                              Fenhexamid
                              CAS No 126833-17-8
                              CIPAC No 603

                              N-(2,3-dichloro-4-hydroxyphenyl)-1- methylcyclohexanecarboxamide

                              ≥ 950 g/kg

                              1 June 2001

                              31 December 2015

                              Only uses as a fungicide may be authorized.
                              In decision making according to the Uniform Principles Member States must pay particular attention to the potential impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.
                              Date of Standing Committee on Plant Health at which the review report was finalised: 19 October 2000.

                              14

                              Amitrole
                              CAS No 61-82-5
                              CIPAC No 90

                              H-[1,2,4]-triazole-3-ylamine

                              900 g/kg

                              1 January 2002

                              31 December 2015

                              Only uses as herbicide may be authorised
                              For the implementation of the uniform principles of Annex VI, the conclusions of the review report on amitrole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 12 December 2000 shall be taken into account. In this overall assessment Member States:

                                          —

                                          must pay particular attention to the protection of operators;

                                          —

                                          must pay particular attention to the protection of the groundwater in vulnerable areas, in particular with respect to non-crop uses;

                                          —

                                          must pay particular attention to the protection of beneficial arthropods;

                                          —

                                          must pay particular attention to the protection of birds and wild mammals. Use of amitrole during the breeding season may only be authorised when an appropriate risk assessment has demonstrated that there is no unacceptable impact and when the conditions of authorisation include, where appropriate, risk mitigation measures.

                              15

                              Diquat
                              CAS No 2764-72-9 (ion), 85-00-7 (dibromide)
                              CIPAC No 55

                              9,10-dihydro-8a,10a-diazoniaphenanthrene ion (dibromide)

                              950 g/kg

                              1 January 2002

                              31 December 2015

                              On the basis of currently available information, only uses as terrestrial herbicide and desiccant may be authorised. Uses in aquatic weed control shall not be authorised.
                              For the implementation of the uniform principles of Annex VI, the conclusions of the Review report on diquat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 12 December 2000 shall be taken into account. In this overall assessment Member States:

                                          —

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

                                          —

                                          must pay particular attention to operator safety as related to non-professional use and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

                              16

                              Pyridate
                              CAS No 55512-33.9
                              CIPAC No 447

                              6-chloro-3-phenylpyridazin-4-yl S-octyl thiocarbonate

                              900 g/kg

                              1 January 2002

                              31 December 2015

                              Only uses as herbicide may be authorized.
                              For the implementation of the uniform principles of Annex VI, the conclusions of the Review report on Pyridate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 12 December 2000 shall be taken into account. In this overall assessment Member States:

                                          —

                                          must pay particular attention to the protection of groundwater;

                                          —

                                          must pay particular attention to the potential impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

                              17

                              Thiabendazole
                              CAS No 148-79-8
                              CIPAC No 323

                              2-Thiazol-4-yl-1H-benzimidazole

                              985 g/kg

                              1 January 2002

                              31 December 2015

                              Only uses as fungicide may be authorised. Foliar spray applications shall not be authorised.
                              For the implementation of the uniform principles of Annex VI, the conclusions of the Review report on thiabendazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 12 December 2000 shall be taken into account. In this overall assessment Member States:

                                          —

                                          must pay particular attention to the protection of aquatic and sediment-dwelling organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

                                    Suitable risk mitigation measures (e.g. depuration with diatom earth or activated carbon) have to be implemented to protect surface waters from unacceptable levels of contamination via wastewater.

                              18

                                 Paecilomyces fumosoroseus Apopka strain 97, PFR 97 or CG 170, ATCC20874

                              Not applicable

                              the absence of secondary metabolites should be checked in each fermentation broth by HPLC.

                              1 July 2001

                              31 December 2015

                              Only uses as an insecticide may be authorised.
                              Each fermentation broth should be checked by HPLC to ensure that no secondary metabolites are present.
                              Date of Standing Committee on Plant Health at which the review report was finalised: 27 April 2001.

                              19

                              DPX KE 459 (flupyrsulfuron-methyl)
                              CAS No 144740-54-5
                              CIPAC No 577

                              2-(4,6-dimethoxypyrimidin-2-ylcarbamoylsulfamoyl)-6-trifluromethylnicotinate monosodium salt

                              903 g/kg

                              1 July 2001

                              31 December 2015

                              Only uses as a herbicide may be authorised.
                              In decision making according to the Uniform Principles Member States must pay particular attention to the protection of groundwater.
                              Date of Standing Committee on Plant Health at which the review report was finalised: 27 April 2001.

                              20

                              Acibenzolar-s-methyl
                              CAS No 135158-54-2
                              CIPAC No 597

                              benzo[1,2,3]thiadiazole-7-carbothioic acid S-methyl ester

                              970 g/kg

                              1 November 2001

                              31 December 2015

                              Only uses as a plant activator may be authorised.
                              Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001

                              21

                              Cyclanilide
                              CAS No 113136-77-9
                              CIPAC No 586

                              Not available

                              960 g/kg

                              1 November 2001

                              31 December 2015

                              Only uses as a plant growth regulator may be authorised.
                              The maximum content of the impurity 2,4-dichloroaniline (2,4-DCA) in the active substance as manufactured should be 1 g/kg.
                              Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001.

                              22

                              Ferric phosphate
                              CAS No 10045-86-0
                              CIPAC No 629

                              Ferric Phosphate

                              990 g/kg

                              1 November 2001

                              31 December 2015

                              Only uses as a molluscicide may be authorised.
                              Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001.

                              23

                              Pymetrozine
                              CAS No 123312-89-0
                              CIPAC No 593

                              (E)-6-methyl-4-[(pyridin-3-ylmethylene)amino]-4,5-dihydro-2H-[1,2,4]-triazin-3 one

                              950 g/kg

                              1 November 2001

                              31 December 2015

                              Only uses as an insecticide may be authorised.
                              In decision making according to the Uniform Principles Member States must pay particular attention to the protection of aquatic organisms.
                              Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001.

                              24

                              Pyraflufen-ethyl
                              CAS No 129630-19-9
                              CIPAC No 605

                              Ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methylpyrazol-3-yl)-4-fluorophenoxyacetate

                              956 g/kg

                              1 November 2001

                              31 December 2015

                              Only uses as a herbicide may be authorised.
                              In decision making according to the Uniform Principles Member States must pay particular attention to the protection of algae and aquatic plants and should apply, where appropriate, risk mitigation measures.
                              Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001.

                              25

                              Glyphosate
                              CAS No 1071-83-6
                              CIPAC No 284

                              N-(phosphonomethyl)-glycin

                              950 g/kg

                              1 July 2002

                              31 December 2015

                              Only uses as herbicide may be authorised
                              For the implementation of the uniform principles of Annex VI, the conclusions of the review report on glyphosate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 29 June 2001 shall be taken into account. In this overall assessment Member States:

                                          —

                                          must pay particular attention to the protection of the groundwater in vulnerable areas, in particular with respect to non-crop uses.

                              26

                              Thifensulfuron-methyl
                              CAS No 79277-27-3
                              CIPAC No 452

                              Methyl 3-(4-methoxy-6-methyl-1,3,5-triazin-2-ylcarbamoyl-sulfamoyl)thiophene-2-carboxylate

                              960 g/kg

                              1 July 2002

                              31 December 2015

                              Only uses as herbicide may be authorised
                              For the implementation of the uniform principles of Annex VI, the conclusions of the review report on thifensulfuron-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 29 June 2001 shall be taken into account. In this overall assessment Member States:

                                          —

                                          must pay particular attention to the protection of groundwater;

                                          —

                                          must pay particular attention to the impact on aquatic plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

                              27

                              2,4-D
                              CAS No 94-75-7
                              CIPAC No 1

                              (2,4-dichlorophenoxy) acetic acid

                              960 g/kg

                              1 October 2002

                              31 December 2015

                              Only uses as herbicide may be authorised
                              For the implementation of the uniform principles of Annex VI, the conclusions of the review report on 2,4-D, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 2 October 2001 shall be taken into account. In this overall assessment Member States:

                                          —

                                          must pay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

                                          —

                                          must pay particular attention to the dermal absorption;

                                          —

                                          must pay particular attention to the protection of non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

                              28

                              Isoproturon
                              CAS No 34123-59-6
                              CIPAC No 336

                              3-(4-isopropylphenyl)-1,1-dimethylurea

                              970 g/kg

                              1 January 2003

                              31 December 2015

                              Only uses as herbicide may be authorised
                              For the implementation of the uniform principles of Annex VI, the conclusions of the review report on isoproturon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 7 December 2001 shall be taken into account. In this overall assessment Member States:

                                          —

                                          must pay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions or at use rates higher than those described in the review report and must apply risk mitigation measures, where appropriate;

                                          —

                                          must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.’

                  (3)

                  Rows 30 to 39 are replaced by the following:

                              No

                              Common Name, Identification Numbers

                              IUPAC Name

                              Purity (3)

                              Entry into force

                              Expiration of inclusion

                              Specific provisions

                              ‘30

                              Iprovalicarb
                              CAS No 140923-17-7
                              CIPAC No 620

                              {2-Methyl-1-[1-(4-methylphenyl)ethylcarbonyl]propyl}- carbamic acid isopropylester

                              950 g/kg
                              (provisional specification)

                              1 July 2002

                              31 December 2015

                              Only uses as fungicide may be authorised.
                              For the implementation of the uniform principles of Annex VI, the conclusions of the review report on iprovalicarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2002 shall be taken into account. In this overall assessment:

                                          —

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

                                          —

                                          Member States must pay particular attention to the protection of operators.

                              31

                              Prosulfuron
                              CAS No 94125-34-5
                              CIPAC No 579

                              1-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-3-[2-(3,3,3-trifluoropropyl)-phenylsulfonyl]-urea

                              950 g/kg

                              1 July 2002

                              31 December 2015

                              Only uses as herbicide may be authorised.
                              For the implementation of the uniform principles of Annex VI, the conclusions of the review report on prosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2002 shall be taken into account. In this overall assessment Member States:

                                          —

                                          must carefully consider the risk to aquatic plants if the active substance is applied adjacent to surface waters. Risk mitigation measures should be applied where appropriate;

                                          —

                                          must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Risk mitigation measures should be applied where appropriate.

                              32

                              Sulfosulfuron
                              CAS No 141776-32-1
                              CIPAC No 601

                              1-(4,6-dimethoxypyrimidin-2-yl)-3-[(2-ethanesulfonyl-imidazo[1,2-a]pyridine) sulfonyl]urea

                              980 g/kg

                              1 July 2002

                              31 December 2015

                              Only uses as a herbicide may be authorised.
                              For the implementation of the uniform principles of Annex VI, the conclusions of the review report on sulfosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2002 shall be taken into account. In this overall assessment

                                          —

                                          Member States must pay particular attention to the protection of aquatic plants and algae. Where appropriate, risk mitigation measures should be applied;

                                          —

                                          Member States must pay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.

                              33

                              Cinidon-ethyl
                              CAS No 142891-20-1
                              CIPAC No 598

                              (Z)-ethyl 2-chloro-3-[2-chloro-5-(cyclohex-1-ene-1,2-dicarboximido)phenyl]acrylate

                              940 g/kg

                              1 October 2002

                              31 December 2015

                              Only uses as herbicide may be authorised.
                              For the implementation of the uniform principles of Annex VI, the conclusions of the review report on cinidon-ethyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment Member States:

                                          —

                                          should pay particular attention to the potential for ground water contamination, when the active substance is applied in regions with vulnerable soil (e.g. soils with neutral or high pH values) and/or climatic conditions;

                                          —

                                          should pay particular attention to the protection of aquatic organisms.

                                    Conditions of authorisation must include risk mitigation measures, where appropriate.

                              34

                              Cyhalofop butyl
                              CAS No 122008-85-9
                              CIPAC No 596

                              Butyl-(R)-2-[4(4-cyano-2-fluorophenoxy) phenoxy]propionate

                              950 g/kg

                              1 October 2002

                              31 December 2015

                              Only uses as herbicide may be authorised.
                              For the implementation of the uniform principles of Annex VI, the conclusions of the review report on cyhalofop butyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment

                                          —

                                          Member States must carefully consider the potential impact of aerial applications to non-target organisms and in particular to aquatic species. Conditions of authorisation must include restrictions or risk mitigation measures, where appropriate.

                                          —

                                          Member States must carefully consider the potential impact of terrestrial applications on aquatic organisms within paddy fields. Conditions of authorisation must include risk mitigation measures, where appropriate.

                              35

                              Famoxadone
                              CAS No 131807-57-3
                              CIPAC No 594

                              3-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-dione

                              960 g/kg

                              1 October 2002

                              31 December 2015

                              Only uses as fungicide may be authorised.
                              For the implementation of the uniform principles of Annex VI, the conclusions of the review report on famoxadone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment:

                                          —

                                          Member States must pay particular attention to potential chronic risks of the parent substance or metabolites to earthworms;

                                          —

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

                                          —

                                          Member States should pay particular attention to the protection of operators.

                              36

                              Florasulam
                              CAS No 145701-23-1
                              CIPAC No 616

                              2', 6', 8-Trifluoro-5-methoxy-[1,2,4]-triazolo [1,5-c] pyrimidine-2-sulphonanilide

                              970 g/kg

                              1 October 2002

                              31 December 2015

                              Only uses as herbicide may be authorised.
                              For the implementation of the uniform principles of Annex VI, the conclusions of the review report on florasulam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment Member States:

                                          —

                                          should pay particular attention to the potential for ground water contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate.

                              37

                              Metalaxyl-M
                              CAS No 70630-17-0
                              CIPAC No 580

                              Methyl (R)-2-{[(2,6-dimethylphenyl)methoxyacetyl] amino} propionate

                              910 g/kg

                              1 October 2002

                              31 December 2015

                              Only uses as fungicide may be authorised.
                              For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Metalaxyl-M, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment:

                                          —

                                          particular attention should be given to the potential for groundwater contamination by the active substance or its degradation products CGA 62826, and CGA 108906 when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Risk mitigation measures should be applied, where appropriate.

                              38

                              Picolinafen
                              CAS No 137641-05-5
                              CIPAC No 639

                              4′-Fluoro-6-[(α,α,α-trifluoro-m-tolyl)oxy]picolinanilide

                              970 g/kg

                              1 October 2002

                              31 December 2015

                              Only uses as herbicide may be authorised.
                              For the implementation of the uniform principles of Annex VI, the conclusions of the review report on picolinafen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment Member States:

                                          —

                                          must pay particular attention to the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.

                              39

                              Flumioxazine
                              CAS No 103361-09-7
                              CIPAC No 578

                              N-(7-fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2H-1,4-benzoxazin-6-yl)cyclohex-1-ene-1,2-dicarboximide

                              960 g/kg

                              1 January 2003

                              31 December 2015

                              Only uses as herbicide may be authorised.
                              For the implementation of the uniform principles of Annex VI, the conclusions of the review report on flumioxazine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 June 2002 shall be taken into account. In this overall assessment Member States:

                                          —

                                          must carefully consider the risk to aquatic plants and algae. Conditions of authorisation must include risk mitigation measures, where appropriate.’

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

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

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


title: Commission Directive 2010/83/EU of 30 November 2010 amending Council Directive 91/414/EEC to include napropamide as active substance  Text with EEA relevance

text:
               1.12.2010

               EN

               Official Journal of the European Union

               L 315/29

         COMMISSION DIRECTIVE 2010/83/EU
   of 30 November 2010
   amending Council Directive 91/414/EEC to include napropamide as active substance
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               Commission Regulations (EC) No 451/2000 (2) and (EC) No 1490/2002 (3) lay down the detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list included napropamide. By Commission Decision 2008/902/EC (4) it was decided not to include napropamide in Annex I to Directive 91/414/EEC.

               (2)

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

               (3)

               The application was submitted to Denmark, 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 has been clarified. The supported uses are the same as those that were the subject of Decision 2008/902/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.

               (4)

               Denmark evaluated the new information and 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 30 June 2009. The Authority communicated the additional report to the other Member States and the applicant for comments and forwarded the comments it had received to the Commission. In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on napropamide to the Commission on 26 March 2010 (6). The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 28 October 2010 in the format of the Commission review report for napropamide.

               (5)

               The additional report by the rapporteur Member State and the new conclusion by the Authority concentrate on the concerns that lead to the non-inclusion. Those concerns were in particular the potential contamination of groundwater by the metabolite 2-(1-naphthyloxy)propionic acid, hereinafter ‘NOPA’, and the risk to mammals, fish-eating birds and aquatic organisms. The new data submitted by the applicant show the following. The metabolite NOPA is neither of toxicological nor of biological relevance. Moreover, the risk to birds and mammals may be considered low, while for the risk for aquatic organisms acceptable uses were identified, on the basis of the additional data provided.

               (6)

               Consequently, the additional data and information provided by the applicant permit to eliminate the specific concerns that led to the non-inclusion. No other open scientific questions have arisen.

               (7)

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

               (8)

               Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EC provides that the inclusion of a substance in Annex I may be subject to conditions. Therefore, it is appropriate to require that the applicant submits information on the aquatic risk for the photolysis metabolites and for NOPA, and information for the risk assessment of aquatic plants.

               (9)

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

               (10)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 2011 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 3
   This Directive shall enter into force on 1 January 2011.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 30 November 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 55, 29.2.2000, p. 25.

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

      (4)  OJ L 326, 4.12.2008, p. 35.

      (5)  OJ L 15, 18.1.2008, p. 5.

      (6)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance napropamide. EFSA Journal 2010; 8(4):1565. [73 pp.]. doi:10.2903/j.efsa.2010.1565. Available online: www.efsa.europa.eu

      ANNEX
      The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:

                     No

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘315

                     Napropamide
                     CAS No: 15299-99-7

                     (RS)-N,N-diethyl-2-(1-naphthyloxy)propionamide

                     ≥ 930 g/kg
                     (Racemic mixture)
                     Relevant impurity
                     Toluene: not more than 1,4 g/kg

                     1 January 2011

                     31 December 2020

                     PART A
                     Only uses as herbicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on napropamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010, shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 —

                                 operator safety: conditions of use shall prescribe the use of adequate personal protective equipment, where necessary,

                                 —

                                 protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones,

                                 —

                                 consumer safety as regards the occurrence in groundwater of the metabolite 2-(1-naphthyloxy)propionic acid, hereinafter “NOPA”.

                           The Member States concerned shall ensure that the applicant presents to the Commission, by 31 December 2012 at the latest, information confirming the surface water exposure assessment as regards the photolysis metabolites and the metabolite NOPA and information for the risk assessment of aquatic plants.’

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


title: Commission Directive 2010/58/EU of 23 August 2010 amending Council Directive 91/414/EEC as regards an extension of the use of the active substance iprodione  Text with EEA relevance

text:
               24.8.2010

               EN

               Official Journal of the European Union

               L 221/12

         COMMISSION DIRECTIVE 2010/58/EU
   of 23 August 2010
   amending Council Directive 91/414/EEC as regards an extension of the use of the active substance iprodione
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular the second indent of the second subparagraph of Article 6(1) thereof,
   Whereas:

               (1)

               By Commission Directive 2003/31/EC (2) iprodione was included as active substance in Annex I to Directive 91/414/EEC.

               (2)

               When applying for the inclusion of iprodione its sole notifier Bayer submitted data on uses as fungicide which supported the overall conclusion that it may be expected that plant protection products containing iprodione will fulfil the safety requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC.

               (3)

               In addition to that use, another notifier Devgen has applied for an amendment to allow iprodione to be used as nematicide. In order to support such an extension of the use, the notifier Devgen submitted additional information.

               (4)

               France has evaluated the information submitted and informed the Commission on 12 January 2010 about its conclusions that the requested extension of use does not cause any risks in addition to those already taken into account in the specific provisions for iprodione in Annex I to Directive 91/414/EEC and in the Commission review report for that substance. In particular, France has prepared several addenda to the assessment report in the concerned areas of the risk assessment, whose conclusions confirm the acceptability of such extension of use.

               (5)

               Therefore, it is justified to modify the specific provisions for iprodione.

               (6)

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

               (7)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   Member States shall adopt and publish by 24 December 2010 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 25 December 2010.
   When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 3
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 23 August 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 101, 23.4.2003, p. 3.

      ANNEX
      In Annex I to Directive 91/414/EEC, row 50 is replaced by the following:

                     No

                     Common name, identification numbers

                     IUPAC name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘50

                     Iprodione
                     CAS No 36734-19-7
                     CIPAC No 278

                     3-(3,5-dichlorophenyl)-Nisopropyl-2,4-dioxo-imidazolidine-1-carboximide

                     960 g/kg

                     1 January 2004

                     31 December 2013

                     Only uses as fungicide and nematicide may be authorised.
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on iprodione, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment, Member States:

                                 —

                                 should pay particular attention to the potential for groundwater contamination when the active substance is applied at high use rates (in particular use in turf) on acidic soils (pH below 6) under vulnerable climatic conditions,

                                 —

                                 must carefully consider the risk to aquatic invertebrates if the active substance is applied directly adjacent to surface waters. Risk mitigation measures should be applied, where appropriate.’

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


title: Commission Directive 2011/5/EU of 20 January 2011 amending Council Directive 91/414/EEC to include hymexazol as active substance and amending Decision 2008/934/EC  Text with EEA relevance

text:
               21.1.2011

               EN

               Official Journal of the European Union

               L 18/34

         COMMISSION DIRECTIVE 2011/5/EU
   of 20 January 2011
   amending Council Directive 91/414/EEC to include hymexazol as active substance and amending Decision 2008/934/EC
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

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

               (2)

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

               (3)

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

               (4)

               The application was submitted to Finland, which had been designated rapporteur Member State by Regulation (EC) No 451/2000. The time period for the accelerated procedure was respected. The specification of the active substance and the supported uses are the same as were the subject of Decision 2008/934/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.

               (5)

               Finland evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 17 September 2009. The Authority communicated the additional report to the other Member States and the applicant for comments and forwarded the comments it had received to the Commission. In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on hymexazol to the Commission on 4 November 2010 (6). The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 23 November 2010 in the format of the Commission review report for hymexazol.

               (6)

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

               (7)

               Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore, it is appropriate to require that the applicant submit further information confirming the nature of residues in root crops and to confirm the risk for granivorous birds and mammals.

               (8)

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

               (9)

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

               (10)

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

               (11)

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

               (12)

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

               (13)

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

               (14)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   The line concerning hymexazol in the Annex to Decision 2008/934/EC is deleted.
   Article 3
   Member States shall adopt and publish by 30 November 2011 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 December 2011.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 4
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing hymexazol as an active substance by 1 December 2011.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to hymexazol are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing hymexazol as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 May 2011 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning hymexazol. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
   Following that determination Member States shall:

               (a)

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

               (b)

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

         Article 5
   This Directive shall enter into force on 1 June 2011.
   Article 6
   This Directive is addressed to the Member States.

      Done at Brussels, 20 January 2011.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 55, 29.2.2000, p. 25.

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

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

      (5)  OJ L 15, 18.1.2008, p. 5.

      (6)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance hymexazol. EFSA Journal 2010; 8(11):1653. [63 pp.]. doi:10.2903/j.efsa.2010.1653. Available online: www.efsa.europa.eu

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

      ANNEX
      The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:

                     No

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘318

                     Hymexazol
                     CAS No:

                        10004-44-1

                     CIPAC No: 528

                     5-methylisoxazol-3-ol (or 5-methyl-1,2-oxazol-3-ol)

                     ≥ 985 g/kg

                     1 June 2011

                     31 May 2021

                     PART A
                     Only uses as fungicide for seed pelleting of sugar beets in professional seed treatment facilities may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on hymexazol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 —

                                 the operators and workers safety. Conditions of authorisation shall include protective measures, where appropriate,

                                 —

                                 the risk to granivorous birds and mammals.

                           Conditions of use shall include risk mitigation measures, where appropriate.
                     The Member States concerned shall request the submission of confirmatory information as regards the nature of residues in root crops and the risk for granivorous birds and mammals.
                     The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.’

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