title: Commission Implementing Directive 2011/52/EU of 20 April 2011 amending Council Directive 91/414/EEC to include carboxin as active substance and amending Commission Decision 2008/934/EC  Text with EEA relevance

text:
               21.4.2011

               EN

               Official Journal of the European Union

               L 105/19

         COMMISSION IMPLEMENTING DIRECTIVE 2011/52/EU
   of 20 April 2011
   amending Council Directive 91/414/EEC to include carboxin as active substance and amending Commission Decision 2008/934/EC
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to 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 second and third stages of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list included carboxin.

               (2)

               In accordance with Article 11e of Regulation (EC) No 1490/2002 the notifier withdrew its support of the inclusion of that active substance in Annex I to Directive 91/414/EEC within 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 carboxin.

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

               (5)

               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 4 December 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 carboxin to the Commission on 11 October 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 11 March 2011 in the format of the Commission review report for carboxin.

               (6)

               It has appeared from the various examinations made that plant protection products containing carboxin 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 carboxin in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.

               (7)

               Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore, it is appropriate to require that the applicant submit further confirmatory information as regards: the specification of the technical material, as commercially manufactured, including appropriate analytical data, the relevance of the impurities, comparison and verification of the test material used in the mammalian toxicity and ecotoxicity dossiers against the specification of the technical material, analytical methods for the monitoring of the metabolite M6 (7) in soil, groundwater and surface water and for the monitoring of metabolite M9 (8) in groundwater, additional values regarding the period required for 50 percent dissipation in soil for the soil metabolites P/V-54 (9) and P/V-55 (10), rotational crop metabolism, the long-term risk to granivorous birds, granivorous mammals and herbivorous mammals and the relevance for ground water of the soil metabolites P/V-54, P/V-55 and M9 if carboxin is classified under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (11) as ‘suspected of causing cancer’.

               (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 carboxin 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 (12) 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 carboxin and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning carboxin 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 carboxin 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 carboxin as an active substance by 30 November 2011.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to carboxin 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 carboxin 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 carboxin. 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 carboxin 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 carboxin 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 April 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 carboxin. EFSA Journal 2010; 8(10):1857. [65 pp.]. doi:10.2903/j.efsa.2010.1857. Available online: www.efsa.europa.eu

      (7)  2-{[anilino(oxo)acetyl]sulfanyl}ethyl acetate.

      (8)  (2RS)-2-hydroxy-2-methyl-N-phenyl-1,4-oxathiane-3-carboxamide 4-oxide.

      (9)  2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4-oxide.

      (10)  2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4,4-dioxide.

      (11)  OJ L 353, 31.12.2008, p. 1.

      (12)  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

                     ‘357

                     Carboxin
                     CAS No: 5234-68-4
                     CIPAC No: 273

                     5,6-dihydro-2-methyl-1,4-oxathiine-3-carboxanilide

                     ≥ 970 g/kg

                     1 June 2011

                     31 May 2021

                     PART A
                     Only uses as fungicide for seed treatment may be authorised.
                     Member States shall ensure that authorisations provide that seed coating be performed exclusively in professional seed treatment facilities and that these facilities apply the best available techniques to exclude the release of dust clouds during storage, transport and application.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on carboxin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 (a)

                                 the risk to operators;

                                 (b)

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

                                 (c)

                                 the risk to 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:

                                 (a)

                                 the specification of the technical material, as commercially manufactured, including appropriate analytical data;

                                 (b)

                                 the relevance of the impurities;

                                 (c)

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

                                 (d)

                                 analytical methods for the monitoring of the metabolite M6 (2) in soil, groundwater and surface water and for the monitoring of metabolite M9 (3) in groundwater;

                                 (e)

                                 additional values regarding the period required for 50 percent dissipation in soil for the soil metabolites P/V-54 (4) and P/V-55 (5);

                                 (f)

                                 rotational crop metabolism;

                                 (g)

                                 the long-term risk to granivorous birds, granivorous mammals and herbivorous mammals;

                                 (h)

                                 the relevance for ground water of the soil metabolites P/V-54, P/V-55 and M9 if carboxin is classified under Regulation (EC) No 1272/2008 as “suspected of causing cancer”.

                           The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b) and (c) by 1 December 2011, the information set out in points (d), (e), (f) and (g) by 31 May 2013 and the information set out in point (h) within six months after the notification of the Decision classifying carboxin.’

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

         (2)  2-{[anilino(oxo)acetyl]sulfanyl}ethyl acetate.

         (3)  (2RS)-2-hydroxy-2-methyl-N-phenyl-1,4-oxathiane-3-carboxamide 4-oxide.

         (4)  2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4-oxide.

         (5)  2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4,4-dioxide.


title: Commission Implementing Directive 2011/53/EU of 20 April 2011 amending Council Directive 91/414/EEC to include dazomet as active substance and amending Commission Decision 2008/934/EC  Text with EEA relevance

text:
               21.4.2011

               EN

               Official Journal of the European Union

               L 105/24

         COMMISSION IMPLEMENTING DIRECTIVE 2011/53/EU
   of 20 April 2011
   amending Council Directive 91/414/EEC to include dazomet as active substance and amending Commission Decision 2008/934/EC
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to 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 second and third stages of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list included dazomet.

               (2)

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

               (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 Belgium, which had been designated rapporteur Member State by Regulation (EC) No 1490/2002. The time period for the accelerated procedure was respected. The specification of the active substance and the supported uses are the same as 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)

               Belgium evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 10 December 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 dazomet to the Commission on 30 September 2010 (6). The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 11 March 2011 in the format of the Commission review report for dazomet.

               (6)

               It has appeared from the various examinations made that plant protection products containing dazomet 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 dazomet 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 to confirm the potential groundwater contamination by methyl isothiocyanate, the assessment of the long range atmospheric transport potential of methyl isothiocyanate and related environmental risks, the acute risk to insectivorous birds and the long term risk to 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 6 months after inclusion to review existing authorisations of plant protection products containing dazomet 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 dazomet and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning dazomet 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 dazomet 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 dazomet as an active substance by 30 November 2011.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to dazomet 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 dazomet 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 dazomet. 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 dazomet 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 dazomet 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 April 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 dazomet. EFSA Journal 2010; 8(10):1833. [91 pp.]. doi:10.2903/j.efsa.2010.1833. 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

                     ‘359

                     Dazomet
                     CAS No: 533-74-4
                     CIPAC No: 146

                     3,5-dimethyl-1,3,5-thiadiazinane-2-thione
                     or
                     tetrahydro-3,5-dimethyl-1,3,5-thiadiazine-2-thione

                     ≥ 950 g/kg

                     1 June 2011

                     31 May 2021

                     PART A
                     Only uses as nematicide, fungicide, herbicide and insecticide may be authorised. Only application as soil fumigant may be authorised. Use shall be limited to one application every third year.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on dazomet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 (a)

                                 the risk to operators, workers and bystanders;

                                 (b)

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

                                 (c)

                                 the risk to aquatic organisms.

                           Conditions of use shall include risk mitigation measures, where appropriate.
                     The Member States concerned shall request the submission of confirmatory information as regards:

                                 (a)

                                 the potential groundwater contamination by methyl isothiocyanate;

                                 (b)

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

                                 (c)

                                 the acute risk to insectivorous birds;

                                 (d)

                                 the long term risk to birds and mammals.

                           The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b), (c) and (d) by 31 May 2013.’

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


title: Commission Implementing Directive 2011/48/EU of 15 April 2011 amending Council Directive 91/414/EEC to include bromadiolone as active substance and amending Commission Decision 2008/941/EC  Text with EEA relevance

text:
               16.4.2011

               EN

               Official Journal of the European Union

               L 102/28

         COMMISSION IMPLEMENTING DIRECTIVE 2011/48/EU
   of 15 April 2011
   amending Council Directive 91/414/EEC to include bromadiolone as active substance and amending Commission Decision 2008/941/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 1112/2002 (2) and (EC) No 2229/2004 (3) lay down the detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list included bromadiolone.

               (2)

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

               (3)

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

               (4)

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

               (5)

               Sweden 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 4 December 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 bromadiolone to the Commission on 15 September 2010 (6). The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 11 March 2011 in the format of the Commission review report for bromadiolone.

               (6)

               It has appeared from the various examinations made that plant protection products containing bromadiolone 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 bromadiolone 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 information as regards: the specification of the technical material as commercially manufactured, in the form of appropriate analytical data, the relevance of the impurities, the determination of bromadiolone in water, the effectiveness of proposed mitigation measures to reduce the risk to birds and non-target mammals and the groundwater exposure assessment in respect of metabolites.

               (8)

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

               (9)

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

               (10)

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

               (11)

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

               (12)

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

               (13)

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

               (14)

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

         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 bromadiolone in the Annex to Decision 2008/941/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 bromadiolone as an active substance by 30 November 2011.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to bromadiolone 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 bromadiolone 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 bromadiolone. 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 bromadiolone 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 bromadiolone 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, 15 April 2011.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 168, 27.6.2002, p. 14.

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

      (4)  OJ L 335, 13.12.2008, p. 91.

      (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 bromadiolone. EFSA Journal 2010;8(10):1783. [44 pp.] doi:10.2903/j.efsa.2010.1783. Available online: www.efsa.europa.eu/efsajournal.htm

      (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

                     ‘352

                     bromadiolone
                     CAS No: 28772-56-7
                     CIPAC No: 371

                        3-[(1RS,3RS;1RS,3SR)-3-(4′-bromobiphenyl-4-yl)-3-hydroxy-1-phenylpropyl]-4-hydroxycoumarin

                     ≥ 970 g/kg

                     1 June 2011

                     31 May 2021

                     PART A
                     Only uses as rodenticide in the form of pre-prepared baits placed into the rodent tunnels may be authorised.
                     The nominal concentration of the active substance in the plant protection products shall not exceed 50 mg/kg.
                     Authorisations shall be granted for uses by professional users only.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on bromadiolone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.
                     In this overall assessment Member States shall:

                                 —

                                 pay particular attention to the risk to professional operators and ensure that conditions of use include the application of adequate personal protective equipment where appropriate,

                                 —

                                 pay particular attention to the risk to birds and non-target mammals from primary and secondary poisoning.

                           Conditions of authorisation shall include risk mitigation measures, where appropriate.
                     The Member States concerned shall request the submission of confirmatory information as regards:

                                 (a)

                                 the specification of the technical material, as commercially manufactured, in the form of appropriate analytical data;

                                 (b)

                                 the relevance of the impurities;

                                 (c)

                                 the determination of bromadiolone in water with a limit of quantification of 0,01 μg/l;

                                 (d)

                                 the effectiveness of proposed mitigation measures to reduce risk to birds and non-target mammals;

                                 (e)

                                 the groundwater exposure assessment in respect of metabolites.

                           The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b) and (c) by 30 November 2011 and the information set out in points (d) and (e) by 31 May 2013.’

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


title: Commission Delegated Directive 2014/72/EU of 13 March 2014 amending, for the purposes of adapting to technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in solders and termination finishes of electrical and electronic components and finishes of printed circuit boards used in ignition modules and other electrical and electronic engine control systems  Text with EEA relevance

text:
               20.5.2014

               EN

               Official Journal of the European Union

               L 148/78

         COMMISSION DELEGATED DIRECTIVE 2014/72/EU
   of 13 March 2014
   amending, for the purposes of adapting to technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in solders and termination finishes of electrical and electronic components and finishes of printed circuit boards used in ignition modules and other electrical and electronic engine control systems
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment, (1) and in particular Article 5(1)(a) thereof,
   Whereas:

               (1)

               Directive 2011/65/EU prohibits the use of lead in electrical and electronic equipment placed on the market.

               (2)

               Ignition modules and other electrical and electronic combustion engine control systems, which have to be mounted close to the moving parts of handheld tools and which are indispensable for the operation of the engine, are exposed to high vibrations and intense thermal stress. These harsh environmental conditions require the use of lead. Neither the substitution nor the elimination of lead in these components is technically practicable.

               (3)

               Manufacturers need additional time to make possible lead-free alternatives technically practicable and to demonstrate reliability. The use of lead in solders and termination finishes of electrical and electronic components and finishes of printed circuit boards used in ignition modules and other electrical and electronic engine control systems should therefore be exempted from the prohibition until 31 December 2018. This is a relatively short transition period which is unlikely to have adverse impacts on innovation.

               (4)

               Directive 2011/65/EU should therefore be amended accordingly,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex III to Directive 2011/65/EU is amended as set out in the Annex to this Directive.
   Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by the last day of the sixth month after entry into force at the latest. They shall forthwith communicate to the Commission the text of those provisions.
   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.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 13 March 2014.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 174, 1.7.2011, p. 88.

      ANNEX
      In Annex III to Directive 2011/65/EU the following point 41 is added:

                     ‘41

                     Lead in solders and termination finishes of electrical and electronic components and finishes of printed circuit boards used in ignition modules and other electrical and electronic engine control systems, which for technical reasons must be mounted directly on or in the crankcase or cylinder of hand-held combustion engines (classes SH:1, SH:2, SH:3 of Directive 97/68/EC of the European Parliament and of the Council (1)

                     Expires on 31 December 2018

         (1)  Directive 97/68/EC of the European Parliament and of the Council of 16 December 1997 on the approximation of the laws of the Member States relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery (OJ L 59, 27.2.1998, p. 1).’


title: Commission Implementing Directive 2012/21/EU of 2 August 2012 amending, for the purpose of adaptation to technical progress, Annexes II and III to Council Directive 76/768/EEC relating to cosmetic products  Text with EEA relevance

text:
               3.8.2012

               EN

               Official Journal of the European Union

               L 208/8

         COMMISSION IMPLEMENTING DIRECTIVE 2012/21/EU
   of 2 August 2012
   amending, for the purpose of adaptation to technical progress, Annexes II and III to Council Directive 76/768/EEC relating to cosmetic products
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), and in particular Article 8(2) thereof,
   After consulting the Scientific Committee on Consumer Safety,
   Whereas:

               (1)

               Following the publication of a scientific study in 2001, entitled ‘Use of permanent hair dyes and bladder cancer risk’, the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers, subsequently replaced by the Scientific Committee on Consumer Products (‘SCCP’), pursuant to Commission Decision 2004/210/EC (2), concluded that the potential risks were of concern. The SCCP recommended that the Commission take further steps to control the use of hair dye substances.

               (2)

               The SCCP further recommended an overall safety assessment strategy for hair dye substances including the requirements for testing substances used in hair dye products for their potential genotoxicity or mutagenicity.

               (3)

               Following the opinions of the SCCP, the Commission agreed with Member States and stakeholders on an overall strategy to regulate substances used in hair dye products according to which the industry was required to submit files, containing updated scientific data on the safety of hair dye substances, for a risk assessment by the SCCP.

               (4)

               The SCCP, subsequently replaced by the Scientific Committee on Consumer Safety (‘SCCS’) pursuant to Commission Decision 2008/721/EC of 5 August 2008 setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment and repealing Decision 2004/210/EC (3), assessed the safety of individual substances for which updated files had been submitted by industry.

               (5)

               The last step of the safety assessment strategy was to evaluate possible consumer health risk by reaction products formed by oxidative hair dye substances during the hair dyeing process. Based on the data yet available, the SCCS raised in its opinion of 21 September 2010 no major concern regarding genotoxicity and carcinogenicity of hair dyes and their reaction products currently used in the EU.

               (6)

               In the light of the risk assessment of the submitted safety data and the final opinions given by the SCCS on the safety of individual substances and of the reaction products, it is appropriate to include in Part 1 of Annex III to Directive 76/768/EEC 24 assessed hair dyes which are not regulated within Directive 76/768/EEC.

               (7)

               The substances Hydroxyethyl-2-Nitro-p-Toluidine and HC Red No 10 + HC Red No 11 were provisionally authorised for use in hair dye products until 31 December 2011 under the restrictions and conditions laid down in entries 10 and 50 in Part 2 of Annex III to Directive 76/768/EEC. Based on the final opinions given by the SCCS on their safety, Hydroxyethyl-2-Nitro-p-Toluidine and HC Red No 10 + HC Red No 11 can be considered safe in hair dye products and listed in Part 1 of Annex III to Directive 76/768/EEC.

               (8)

               Following the assessment by the SCCS concerning the substances 1-Naphthol and Resorcinol, listed in Part 1 of Annex III to Directive 76/768/EEC, their maximum authorised concentrations in the finished cosmetic product should be changed.

               (9)

               Concerning the substance HC Red No 16, the SCCS stated in its opinion of 14 December 2010 that based on the low margin of safety for the use in both oxidative and non-oxidative hair dye formulations, HC Red No 16 poses a risk to the health of the consumer. Therefore, HC Red No 16 should be listed in Annex II to Directive 76/768/EEC.

               (10)

               Directive 76/768/EEC should therefore be amended accordingly.

               (11)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annexes II and III to Directive 76/768/EEC are amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by 1 March 2013 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.
   They shall apply those provisions from 1 September 2013.
   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.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 2 August 2012.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 262, 27.9.1976, p. 169.

      (2)  OJ L 66, 4.3.2004, p. 45.

      (3)  OJ L 241, 10.9.2008, p. 21.

      ANNEX
      Directive 76/768/EEC is amended as follows:

                  (1)

                  in Annex II, the following entry is added:

                              Ref. No

                              Chemical name

                              CAS No / EC No

                              ‘1373

                              N-(2-Nitro-4-aminophenyl)-allylamine (HC Red No 16) and its salts

                              CAS No 160219-76-1’

                  (2)

                  Annex III is amended as follows:

                              (a)

                              Part 1 is amended as follows:

                                          (i)

                                          the following entries are added:

                                                      Ref. No

                                                      Substance

                                                      Restrictions

                                                      Conditions of use and warnings which must be printed on the label

                                                      Field of application and/or use

                                                      Max. authorised concentration in the finished cosmetic product

                                                      Other limitations and requirements

                                                      a

                                                      b

                                                      c

                                                      d

                                                      e

                                                      f

                                                      ‘253

                                                      2,2′-[(4-Aminophenyl))imino]bis(ethanol) sulphate
                                                      N,N-bis(2-Hydroxyethyl)-p-Phenylenediamine Sulfate
                                                      CAS No 54381-16-7
                                                      EC No 259-134-5

                                                      Hair dye substance in oxidative hair dye products

                                                      After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,5 % (calculated as sulphate)

                                                                  —

                                                                  Do not use with nitrosating agents

                                                                  —

                                                                  Maximum nitrosamine content: 50 μg/kg

                                                                  —

                                                                  Keep in nitrite-free containers

                                                      As mentioned in reference number 205, column f (a)

                                                      254

                                                      1,3-Benzenediol, 4-chloro-
                                                      4-Chlororesorcinol
                                                      CAS No 95-88-5
                                                      EC No 202-462-0

                                                      Hair dye substance in oxidative hair dye products

                                                      After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,5 %

                                                      As mentioned in reference number 205, column f (a)

                                                      255

                                                      2,4,5,6-Tetraaminopyrimidine sulphate
                                                      Tetraaminopyrimidine Sulfate
                                                      CAS No 5392-28-9
                                                      EC No 226-393-0

                                                                  (a)

                                                                  Hair dye substance in oxidative hair dye products

                                                                  (a)

                                                                  After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 3,4 % (calculated as sulphate)

                                                                  (a)

                                                                  As mentioned in reference number 205, column f (a)

                                                                  (b)

                                                                  Hair dye substance in non-oxidative hair dye products

                                                                  (b)

                                                                  3,4 % (calculated as sulphate)

                                                      256

                                                      3-(2-Hydroxyethyl)-p-phenylenediammonium sulphate
                                                      Hydroxyethyl-p-Phenylenediamine Sulfate
                                                      CAS No 93841-25-9
                                                      EC No 298-995-1

                                                      Hair dye substance in oxidative hair dye products

                                                      After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % (calculated as sulphate)

                                                      As mentioned in reference number 205, column f (a)

                                                      257

                                                      1H-Indole-5,6-diol
                                                      Dihydroxyindole
                                                      CAS No 3131-52-0
                                                      EC No 412-130-9

                                                                  (a)

                                                                  Hair dye substance in oxidative hair dye products

                                                                  (a)

                                                                  After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,5 %

                                                                  (a)

                                                                  As mentioned in reference number 205, column f (a)

                                                                  (b)

                                                                  Hair dye substance in non-oxidative hair dye products

                                                                  (b)

                                                                  0,5 %

                                                                  (b)

                                                                  As mentioned in reference number 208, column f

                                                      258

                                                      5-Amino-4-chloro-2-methylphenol hydrochloride
                                                      5-Amino-4-Chloro-o-Cresol HCl
                                                      CAS No 110102-85-7

                                                      Hair dye substance in oxidative hair dye products

                                                      After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 % (calculated as hydrochloride)

                                                      As mentioned in reference number 205, column f (a)

                                                      259

                                                      1H-Indol-6-ol
                                                      6-Hydroxyindole
                                                      CAS No 2380-86-1
                                                      EC No 417-020-4

                                                      Hair dye substance in oxidative hair dye products

                                                      After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,5 %

                                                      As mentioned in reference number 205, column f (a)

                                                      260

                                                      1H-Indole-2,3-Dione
                                                      Isatin
                                                      CAS No 91-56-5
                                                      EC No 202-077-8

                                                      Hair dye substance in non-oxidative hair dye products

                                                      1,6 %

                                                      As mentioned in reference number 208, column f

                                                      261

                                                      2-Aminopyridin-3-ol
                                                      2-Amino-3-Hydroxypyridine
                                                      CAS No 16867-03-1
                                                      EC No 240-886-8

                                                      Hair dye substance in oxidative hair dye products

                                                      After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %

                                                      As mentioned in reference number 205, column f (a)

                                                      262

                                                      2-Methyl-1-naphthyl acetate
                                                      1-Acetoxy-2-Methylnaphthalene
                                                      CAS No 5697-02-9
                                                      EC No 454-690-7

                                                      Hair dye substance in oxidative hair dye products

                                                      After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % (When both 2-Methyl-1-Naphthol and 1-Acetoxy-2-Methylnaphthalene are present in a hair dye formulation, the maximum concentration on the head of 2-Methyl-1-Naphthol should not exceed 2,0 %.)

                                                      As mentioned in reference number 205, column f (a)

                                                      263

                                                      1-Hydroxy-2-methylnaphthalene
                                                      2-Methyl-1-Naphthol
                                                      CAS No 7469-77-4
                                                      EC No 231-265-2

                                                      Hair dye substance in oxidative hair dye products

                                                      After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % (When both 2-Methyl-1-Naphthol and 1-Acetoxy-2-Methylnaphthalene are present in a hair dye formulation, the maximum concentration on the head of 2-Methyl-1-Naphthol should not exceed 2,0 %.)

                                                      As mentioned in reference number 205, column f (a)

                                                      264

                                                      Disodium 5,7-dinitro-8-oxido-2-naphthalenesulfonate
                                                      Acid Yellow 1
                                                      CAS No 846-70-8
                                                      EC No 212-690-2
                                                      CI 10316

                                                                  (a)

                                                                  Hair dye substance in oxidative hair dye products

                                                                  (a)

                                                                  After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %

                                                                  (a)

                                                                  As mentioned in reference number 205, column f (a)

                                                                  (b)

                                                                  Hair dye substance in non-oxidative hair dye products

                                                                  (b)

                                                                  0,2 %

                                                                  (b)

                                                                  As mentioned in reference number 208, column f

                                                      265

                                                      4-Nitro-1,2-phenylenediamine
                                                      4-Nitro-o-Phenylenediamine
                                                      CAS No 99-56-9
                                                      EC No 202-766-3

                                                      Hair dye substance in oxidative hair dye products

                                                      After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,5 %

                                                      As mentioned in reference number 205, column f (a)

                                                      266

                                                      2-(4-Amino-3-nitroanilino)ethanol
                                                      HC Red No 7
                                                      CAS No 24905-87-1
                                                      EC No 246-521-9

                                                      Hair dye substance in non-oxidative hair dye products

                                                      1,0 %

                                                                  —

                                                                  Do not use with nitrosating agents

                                                                  —

                                                                  Maximum nitrosamine content: 50 μg/kg

                                                                  —

                                                                  Keep in nitrite-free containers

                                                      As mentioned in reference number 208, column f

                                                      267

                                                      2-[bis(2-Hydroxyethyl)amino]-5-nitrophenol
                                                      HC Yellow No 4
                                                      CAS No 59820-43-8
                                                      EC No 428-840-7

                                                      Hair dye substance in non-oxidative hair dye products

                                                      1,5 %

                                                                  —

                                                                  Do not use with nitrosating agents

                                                                  —

                                                                  Maximum nitrosamine content: 50 μg/kg

                                                                  —

                                                                  Keep in nitrite-free containers

                                                      268

                                                      2-[(2-Nitrophenyl)amino]ethanol
                                                      HC Yellow No 2
                                                      CAS No 4926-55-0
                                                      EC No 225-555-8

                                                                  (a)

                                                                  Hair dye substance in oxidative hair dye products

                                                                  (a)

                                                                  After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,75 %

                                                            For (a) and (b):

                                                                  —

                                                                  Do not use with nitrosating agents

                                                                  —

                                                                  Maximum nitrosamine content: 50 μg/kg

                                                                  —

                                                                  Keep in nitrite-free containers

                                                                  (a)

                                                                  As mentioned in reference number 205, column f (a)

                                                                  (b)

                                                                  Hair dye substance in non-oxidative hair dye products

                                                                  (b)

                                                                  1,0 %

                                                      269

                                                      4-[(2-Nitrophenyl)amino]phenol
                                                      HC Orange No 1
                                                      CAS No 54381-08-7
                                                      EC No 259-132-4

                                                      Hair dye substance in non-oxidative hair dye products

                                                      1,0 %

                                                      270

                                                      2-Nitro-N1-phenyl-benzene-1,4-diamine
                                                      HC Red No 1
                                                      CAS No 2784-89-6
                                                      EC No 220-494-3

                                                      Hair dye substance in non-oxidative hair dye products

                                                      1,0 %

                                                      As mentioned in reference number 208, column f

                                                      271

                                                      1-Methoxy-3-(β-aminoethyl)amino-4-nitrobenzene, hydrochloride
                                                      HC Yellow No 9
                                                      CAS No 86419-69-4
                                                      EC No 415-480-1

                                                      Hair dye substance in non-oxidative hair dye products

                                                      0,5 % (calculated as hydrochloride)

                                                                  —

                                                                  Do not use with nitrosating agents

                                                                  —

                                                                  Maximum nitrosamine content: 50 μg/kg

                                                                  —

                                                                  Keep in nitrite-free containers

                                                      272

                                                      1-(4’-Aminophenylazo)-2-methyl-4-(bis-2-hydroxyethyl) aminobenzene
                                                      HC Yellow No 7
                                                      CAS No 104226-21-3
                                                      EC No 146-420-6

                                                      Hair dye substance in non-oxidative hair dye products

                                                      0,25 %

                                                      273

                                                      N-(2-Hydroxyethyl)-2-nitro-4-trifluormethyl-aniline
                                                      HC Yellow No 13
                                                      CAS No 10442-83-8
                                                      EC No 443-760-2

                                                                  (a)

                                                                  Hair dye substance in oxidative hair dye products

                                                                  (a)

                                                                  After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,5 %

                                                            For (a) and (b):

                                                                  —

                                                                  Do not use with nitrosating agents

                                                                  —

                                                                  Maximum nitrosamine content: 50 μg/kg

                                                                  —

                                                                  Keep in nitrite-free containers

                                                                  (a)

                                                                  As mentioned in reference number 205, column f (a)

                                                                  (b)

                                                                  Hair dye substance in non-oxidative hair dye products

                                                                  (b)

                                                                  2,5 %

                                                      274

                                                      Benzenaminium, 3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-N,N,Ntrimethyl-, chloride
                                                      Basic Yellow 57
                                                      CAS No 68391-31-1
                                                      EC No 269-943-5

                                                      Hair dye substance in non-oxidative hair dye products

                                                      2,0 %

                                                      275

                                                      Ethanol, 2,2′-[[4-[(4-aminophenyl)azo]phenyl]imino]bis-
                                                      Disperse Black 9
                                                      CAS No 20721-50-0
                                                      EC No 243-987-5

                                                      Hair dye substance in non-oxidative hair dye products

                                                      0,3 % (of the mixture in the ratio 1:1 of 2,2’-[4-(4-aminophenylazo)phenylimino]diethanol and lignosulfate)

                                                      276

                                                      9,10-Anthracenedione, 1,4-bis[(2,3-dihydroxypropyl)amino]-
                                                      HC Blue No 14
                                                      CAS No 99788-75-7
                                                      EC No 421-470-7

                                                      Hair dye substance in non-oxidative hair dye products

                                                      0,3 %

                                                                  —

                                                                  Do not use with nitrosating agents

                                                                  —

                                                                  Maximum nitrosamine content: 50 μg/kg

                                                                  —

                                                                  Keep in nitrite-free containers

                                                      277

                                                      2-(4-Methyl-2-nitroanilino)ethanol
                                                      Hydroxyethyl-2-Nitro-p-Toluidine
                                                      CAS No 100418-33-5
                                                      EC No 408-090-7

                                                                  (a)

                                                                  Hair dye substance in oxidative hair dye products

                                                                  (a)

                                                                  After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %

                                                            For (a) and (b):

                                                                  —

                                                                  Do not use with nitrosating agents

                                                                  —

                                                                  Maximum nitrosamine content: 50 μg/kg

                                                                  —

                                                                  Keep in nitrite-free containers

                                                                  (a)

                                                                  As mentioned in reference number 205, column f (a)

                                                                  (b)

                                                                  Hair dye substance in non-oxidative hair dye products

                                                                  (b)

                                                                  1,0 %

                                                      278

                                                      1-Amino-2-nitro-4-(2′,3′-dihydroxypropyl)amino-5-chlorobenzene + 1,4-bis-(2′,3′-dihydroxypropyl)amino-2-nitro-5-chlorobenzene
                                                      HC Red No 10 + HC Red No 11
                                                      CAS No 95576-89-9 + 95576-92-4

                                                                  (a)

                                                                  Hair dye substance in oxidative hair dye products

                                                                  (a)

                                                                  After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %

                                                            For (a) and (b):

                                                                  —

                                                                  Do not use with nitrosating agents

                                                                  —

                                                                  Maximum nitrosamine content: 50 μg/kg

                                                                  —

                                                                  Keep in nitrite-free containers

                                                                  (a)

                                                                  As mentioned in reference number 205, column f (a)’

                                                                  (b)

                                                                  Hair dye substance in non-oxidative hair dye products

                                                                  (b)

                                                                  2,0 %

                                          (ii)

                                          the entries with reference numbers 16 and 22 are replaced by the following:

                                                      Ref. No

                                                      Substance

                                                      Restrictions

                                                      Conditions of use and warnings which must be printed on the label

                                                      Field of application and/or use

                                                      Max. authorized concentration in the finished cosmetic product

                                                      Other limitations and requirements

                                                      a

                                                      b

                                                      c

                                                      d

                                                      e

                                                      f

                                                      ‘16

                                                      1-Naphthalenol
                                                      1-Naphthol
                                                      CAS No 90-15-3
                                                      EC No 201-969-4

                                                      Hair dye substance in oxidative hair dye products

                                                      After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 %

                                                      As mentioned in reference number 205, column f (a)

                                                      22

                                                      1,3-benzenediol
                                                      Resorcinol
                                                      CAS No 108-46-3
                                                      EC No 203-585-2

                                                                  (a)

                                                                  Hair dye substance in oxidative hair dye products

                                                                              1.

                                                                              general use

                                                                              2.

                                                                              professional use

                                                                  (a)

                                                                  After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,25 %

                                                                  (a)

                                                                              1.

                                                                              Contains resorcinol
                                                                              Rinse hair well after application.
                                                                              Do not use to dye eyelashes or eyebrows.
                                                                              Rinse eyes immediately if product comes into contact with them.
                                                                              As mentioned in reference number 205, column f (a).

                                                                              2.

                                                                              For professional use only
                                                                              Contains resorcinol.
                                                                              Rinse eyes immediately if product comes into contact with them.
                                                                              As mentioned in reference number 205, column f (a)

                                                                  (b)

                                                                  Hair lotions and shampoos

                                                                  (b)

                                                                  0,5 %

                                                                  (b)

                                                                  Contains resorcinol.’

                              (b)

                              in Part 2 the entries with reference numbers 10 and 50 are deleted.