title: Commission Directive 2009/155/EC of 30 November 2009 amending Council Directive 91/414/EEC as regards the purity level required of the active substance metazachlor (Text with EEA relevance)

text:
               1.12.2009

               EN

               Official Journal of the European Union

               L 314/72

      COMMISSION DIRECTIVE 2009/155/EC
   of 30 November 2009
   amending Council Directive 91/414/EEC as regards the purity level required of the active substance metazachlor
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular the second indent of the second subparagraph of Article 6(1) thereof,
   Whereas:

               (1)

               After an examination in which the United Kingdom acted as rapporteur Member State, Commission Directive 2008/116/EC (2) included the active substance metazachlor in Annex I to Directive 91/414/EEC. With regard to that substance, Directive 2008/116/EC has set a maximum level of 0,01 % for toluene as a manufacturing impurity. That level was based on the specification submitted by the notifier.

               (2)

               The notifier has asked for an amendment to Directive 91/414/EEC raising that maximum level to 0,05 %. It submitted the necessary information in support of its request. On 2 February 2009 the rapporteur Member State presented an addendum (3) to the draft assessment report concluding that a maximum level of 0,05 % does not cause any risk in addition to the risks already taken into account in the Commission review report for that substance.

               (3)

               The maximum level of toluene as a manufacturing impurity of metazachlor should therefore be raised to 0,05 %.

               (4)

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

               (5)

               Since this Directive should start to apply on the same date as Directive 2008/116/EC, this Directive should enter into force as soon as possible.

               (6)

               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
   In row 223 (metazachlor) of Annex I to Directive 91/414/EEC, in column 4 (purity), ‘0,01 %’ is replaced by ‘0,05 %’.
   Article 2
   Member States shall adopt and publish, by 31 January 2010 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 February 2010.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 3
   This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 30 November 2009.

            For the Commission

         Androulla VASSILIOU

            Member of the Commission

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 337, 16.12.2008, p. 86.

      (3)  Addendum 2 — January 2009 — to Volume 4, Annex C to the report and proposed decision of the United Kingdom made to the European Commission under Article 8(1) of Directive 91/414/EEC.


title: Commission Directive 2009/37/EC of 23 April 2009 amending Council Directive 91/414/EEC to include chlormequat, copper compounds, propaquizafop, quizalofop-P, teflubenzuron and zeta-cypermethrin as active substances (Text with EEA relevance)

text:
               24.4.2009

               EN

               Official Journal of the European Union

               L 104/23

      COMMISSION DIRECTIVE 2009/37/EC
   of 23 April 2009
   amending Council Directive 91/414/EEC to include chlormequat, copper compounds, propaquizafop, quizalofop-P, teflubenzuron and zeta-cypermethrin as active substances
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

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

               (2)

               For those active substances the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) No 1490/2002 for a range of uses proposed by the notifiers. Moreover, those Regulations designate the rapporteur Member States which have to submit the relevant assessment reports and recommendations to the European Food Safety Authority (EFSA) in accordance with Article 10(1) of Regulation (EC) No 1490/2002. For chlormequat and teflubenzuron the rapporteur Member State was the United Kingdom and all relevant information was submitted on 27 April 2007 and 6 August 2007 respectively. For copper compounds the rapporteur Member State was France and all relevant information was submitted on 7 June 2007. For propaquizafop the rapporteur Member State was Italy and all relevant information was submitted on 22 September 2005. For quizalofop-P the rapporteur Member State was Finland and all relevant information was submitted on 1 February 2007 (variant quizalofop-P-ethyl) and 2 May 2007 (variant quizalofop-P-tefuryl). For zeta-cypermethrin the rapporteur Member State was Belgium and all relevant information was submitted on 10 July 2006.

               (3)

               The assessment reports have been peer reviewed by the Member States and the EFSA and presented to the Commission on 29 September 2008 for chlormequat and teflubenzuron, on 30 September 2008 for copper compounds and zeta-cypermethrin and on 26 November 2008 for propaquizafop and quizalofop-P in the format of the EFSA Scientific Reports (4). These reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 23 January 2009 in the format of the Commission review reports for chlormequat, copper compounds, propaquizafop, quizalofop-P, teflubenzuron and zeta-cypermethrin.

               (4)

               It has appeared from the various examinations made that plant protection products containing chlormequat, copper compounds, propaquizafop, quizalofop-P, teflubenzuron and zeta-cypermethrin may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review reports. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances can be granted in accordance with the provisions of that Directive.

               (5)

               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, for chlormequat the notifier should be required to submit further information on the fate and behaviour (adsorption studies to be performed at 20 °C, recalculation of the predicted concentrations in groundwater, surface water and sediment), the monitoring methods for determination of the substance in animal products and water, and the risk to aquatic organisms, birds and mammals. Furthermore for copper compounds, the notifier should be required to submit further information on the risk from inhalation and on the risk assessment for non-target organisms, soil and water. Moreover, it is appropriate as regards propaquizafop, to require that the notifier submit information on the relevant impurity Ro 41-5259 and on the risk to aquatic organisms and to non-target arthropods. In addition, it is appropriate as regards quizalofop-P, to require that the notifier submit further information on the risk to non-target arthropods. Finally, it is appropriate for the zeta-cypermethrin to require that the notifier submit further information as regards the fate and behaviour (aerobic degradation in soil), the risk to birds (long-term risk), aquatic organisms and non-target arthropods.

               (6)

               Moreover, with regard to copper compounds, copper occurs in nature and is an essential micronutrient. Copper accumulates in soil and the level of copper in soil can be affected not only by applications of plant protection products but also from animal husbandry and from the application of manure. Therefore, it is necessary that Member States initiate monitoring programmes in vulnerable areas, where the contamination of the soil compartment by copper is of concern, in order to set, where appropriate, limitations such as maximum application rates.

               (7)

               Articles 5(4) and 6(1) of Directive 91/414/EEC provide that inclusion of a substance into Annex I may be subject to restrictions. In the case of copper compounds, the risk assessment revealed eco-toxicological concerns, a restriction on the inclusion period is deemed necessary to allow Member States to review after a shorter period plant protection products already on the market containing copper. Moreover, copper compounds are currently subject to evaluation in the framework of Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (5), as well as to evaluation in the framework of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (6) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). As with all substances included in Annex I to Directive 91/414/EEC, the status of copper compounds could be reviewed under Article 5(5) of that Directive in the light of any new data becoming available.

               (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 chlormequat, copper compounds, propaquizafop, quizalofop-P, teflubenzuron and zeta-cypermethrin 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 way of 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 (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)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   Member States shall adopt and publish by 31 May 2010 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 June 2010.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 3
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing chlormequat, copper compounds, propaquizafop, quizalofop-P, teflubenzuron and zeta-cypermethrin as active substances by 31 May 2010.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to chlormequat, copper compounds, propaquizafop, quizalofop-P, teflubenzuron and zeta-cypermethrin 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 chlormequat, copper compounds, propaquizafop, quizalofop-P, teflubenzuron, zeta-cypermethrin as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 30 November 2009 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 chlormequat, copper compounds, propaquizafop, quizalofop-P, teflubenzuron and zeta-cypermethrin respectively. 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 chlormequat, copper compounds, propaquizafop, quizalofop-P, teflubenzuron and zeta-cypermethrin as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2014 at the latest; or

               (b)

               in the case of a product containing chlormequat, copper compounds, propaquizafop, quizalofop-P, teflubenzuron and zeta-cypermethrin as one of several active substances, where necessary, amend or withdraw the authorisation by 31 May 2014 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 4
   This Directive shall enter into force on 1 December 2009.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 23 April 2009.

            For the Commission

         Androulla VASSILIOU

            Member of the Commission

      (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)  EFSA Scientific Report (2008) 179, Conclusion regarding the peer review of the pesticide risk assessment of the active substance chlormequat (finalised 29 September 2008).
   EFSA Scientific Report (2008) 187, Conclusion regarding the peer review of the pesticide risk assessment of the active substance copper compounds (finalised 30 September 2008).
   EFSA Scientific Report (2008) 204, Conclusion regarding the peer review of the pesticide risk assessment of the active substance propaquizafop (finalised 26 November 2008).
   EFSA Scientific Report (2008) 205, Conclusion regarding the peer review of the pesticide risk assessment of the active substance quizalofop-P (finalised 26 November 2008).
   EFSA Scientific Report (2008) 184, Conclusion regarding the peer review of the pesticide risk assessment of the active substance teflubenzuron (finalised 29 September 2008).
   EFSA Scientific Report (2008) 196, Conclusion regarding the peer review of the pesticide risk assessment of the active substance zeta-cypermethrin (finalised 30 September 2008).

      (5)  OJ L 123, 24.4.1998, p. 1.

      (6)  OJ L 396, 30.12.2006, p. 1; corrected by OJ L 136, 29.5.2007, p. 3.

      (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

                     ‘281

                     Chlormequat
                     CAS No 7003-89-6 (chlormequat)
                     CAS No 999-81-5 (chlormequat chloride)
                     CIPAC No 143 (chlormequat)
                     CIPAC No 143.302 (chlormequat chloride)

                        2-chloroethyltrimethylammonium (chlormequat)

                        2-chloroethyltrimethylammonium chloride (chlormequat chloride)

                     ≥ 636 g/kg
                     Impurities:

                                 1,2-dichloroethane: max 0,1 g/kg (on the dry chlormequat chloride content).

                                 Chloroethene (vinylchloride): max 0,0005 g/kg (on the dry chlormequat chloride content).

                     1 December 2009

                     30 November 2019

                     PART A
                     Only uses as plant growth regulator on cereals may be authorised.
                     PART B
                     In assessing applications to authorise plant protection products containing chlormequat for uses other than in rye and triticale, notably as regards the exposure of consumers, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on chlormequat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

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

                                 —

                                 the protection of birds and mammals.

                           Conditions of authorisation shall include risk mitigation measures, where appropriate.
                     The Member States concerned shall request the submission of further information on the fate and behaviour (adsorption studies to be performed at 20 °C, recalculation of the predicted concentrations in groundwater, surface water and sediment), the monitoring methods for determination of the substance in animal products and water, and the risk to aquatic organisms, birds and mammals. They shall ensure that the notifier at whose request chlormequat has been included in this Annex provide such information to the Commission by 30 November 2011 at the latest.

                     282

                     Copper compounds:

                     1 December 2009

                     30 November 2016

                     PART A
                     Only uses as bactericide and fungicide may be authorised.
                     PART B
                     In assessing applications to authorise plant protection products containing copper for uses other than on tomatoes in greenhouses, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on copper compounds, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

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

                                 —

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

                                 —

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

                                 —

                                 the amount of active substance applied and ensure that the authorised amounts, in terms of rates and number of applications, are the minimum necessary to achieve the desired effects.

                           The concerned Member States shall request the submission of information to further address:

                                 —

                                 the risk from inhalation,

                                 —

                                 the risk assessment for non-target organisms and for soil and water.

                           They shall ensure that the notifier at whose request copper compounds have been included in this Annex provides such information to the Commission by 30 November 2011 at the latest.
                     Member States shall initiate monitoring programmes in vulnerable areas where the contamination of the soil compartment by copper is of concern, in order to set, where appropriate, limitations such as maximum application rates.

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

                        Copper (II) hydroxide

                     ≥ 573 g/kg

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

                        Dicopper chloride trihydroxide

                     ≥ 550 g/kg

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

                        Copper oxide

                     ≥ 820 g/kg

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

                        Not allocated

                     ≥ 245 g/kg

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

                        Not allocated

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

                                 Lead max 0,0005 g/kg of copper content.

                                 Cadmium max 0,0001 g/kg of copper content.

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

                     283

                     Propaquizafop
                     CAS No 111479-05-1
                     CIPAC No 173

                        2-isopropylidenamino-oxyethyl (R)-2-[4-(6-chloro-quinoxalin-2-yloxy)phenoxy]propionate

                     ≥ 920 g/kg
                     Toluene maximum content 5 g/kg

                     1 December 2009

                     30 November 2019

                     PART A
                     Only uses as herbicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on propaquizafop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

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

                                 —

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

                                 —

                                 the protection of aquatic organisms and non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate,

                                 —

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

                           The Member States concerned shall ensure that the notifier submits to the Commission:

                                 —

                                 further information on the relevant impurity Ro 41-5259,

                                 —

                                 information to further address the risk to aquatic organisms and to non-target arthropods.

                           They shall ensure that the notifier provides such information to the Commission by 30 November 2011.

                     284

                     Quizalofop-P:

                     1 December 2009

                     30 November 2019

                     PART A
                     Only uses as herbicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on quizalofop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

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

                                 —

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

                                 —

                                 the protection of non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate.

                           Conditions of authorisation shall include risk mitigation measures, where appropriate.
                     The Member States concerned shall ensure that the notifier submits to the Commission further information on the risk to non-target arthropods.
                     They shall ensure that the notifier provides such information to the Commission by 30 November 2011.

                     Quizalofop-P-ethyl
                     CAS No 100646-51-3
                     CIPAC No 641.202

                        ethyl (R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenoxy]propionate

                     ≥ 950 g/kg

                     Quizalofop-P-tefuryl
                     CAS No 119738-06-6
                     CIPAC No 641.226

                        (RS)-Tetrahydrofurfuryl (R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenoxy]propionate

                     ≥ 795 g/kg

                     285

                     Teflubenzuron
                     CAS No 83121-18-0
                     CIPAC No 450

                     1-(3,5-dichloro-2,4-difluorophenyl)-3-(2,6-difluorobenzoyl)urea

                     ≥ 970 g/kg

                     1 December 2009

                     30 November 2019

                     PART A
                     Only uses as insecticide in glasshouses (on artificial substrate or closed hydroponic systems) may be authorised.
                     PART B
                     In assessing applications to authorise plant protection products containing teflubenzuron for uses other than on tomatoes in greenhouses, Member States shall pay particular attention to the criteria in Article 4(1) (b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on teflubenzuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

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

                                 —

                                 the protection of aquatic organisms. Releases from glasshouse application must be minimised and, in any case, should not have the potential to reach in significant levels water bodies in the vicinity,

                                 —

                                 the protection of bees which should be prevented from accessing the glasshouse,

                                 —

                                 the protection of pollinator colonies purposely placed in the glasshouse,

                                 —

                                 the safe disposal of condensation water, drain water and substrate in order to preclude risks to non-target organisms and contamination of surface water and groundwater.

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

                     286

                     Zeta-cypermethrin
                     CAS No 52315-07-8
                     CIPAC No 733

                     Mixture of the stereoisomers (S)-α-cyano-3-phenoxybenzyl (1RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl)-2,2 dimethylcyclopropanecarboxylate where the ratio of the (S);(1RS,3RS) isomeric pair to the (S);(1RS,3SR) isomeric pair lies in the ratio range 45-55 to 55-45 respectively

                     ≥ 850 g/kg
                     Impurities:

                                 toluene: max 2 g/kg

                                 tars: max 12,5 g/kg

                     1 December 2009

                     30 November 2019

                     PART A
                     Only uses as insecticide may be authorised.
                     PART B
                     In assessing applications to authorise plant protection products containing zeta-cypermethrin for uses other than in cereals, notably as regards the exposure of consumers to mPBAldehyde, a degradation product that may be formed during processing, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on zeta-cypermethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

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

                                 —

                                 the protection of birds, aquatic organisms, bees, non-target arthropods and non-target soil macro-organisms.

                           Conditions of authorisation shall include risk mitigation measures, where appropriate.
                     The Member States concerned shall request the submission of further information on the fate and behaviour (aerobic degradation in soil), the long-term risk to birds, aquatic organisms and non-target arthropods. They shall ensure that the notifier at whose request zeta-cypermethrin has been included in this Annex provide such information to the Commission by 30 November 2011 at the latest.’

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


Avis juridique important

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31982L0287

Commission Directive 82/287/EEC of 13 April 1982 amending the Annexes to Council Directives 66/401/EEC and 69/208/EEC on the marketing of fodder plant seed and seed of oil and fibre plants respectively, and Directives 78/386/EEC and 78/388/EEC

Official Journal L 131 , 13/05/1982 P. 0024 - 0026 Spanish special edition: Chapter 03 Volume 25 P. 0016  Portuguese special edition Chapter 03 Volume 25 P. 0016  Finnish special edition: Chapter 3 Volume 15 P. 0003  Swedish special edition: Chapter 3 Volume 15 P. 0003

*****COMMISSION  DIRECTIVE  of 13 April 1982  amending the Annexes to Council Directives 66/401/EEC and 69/208/EEC on the marketing of fodder plant seed and seed of oil and fibre plants respectively, and Directives 78/386/EEC and 78/388/EEC  (82/287/EEC)  THE COMMISSION OF THE EUROPEAN  COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed (1), as last amended by Directive 81/126/EEC (2), and in particular Article 21a thereof,  Having regard to Council Directive 69/208/EEC of 30 June 1969 on the marketing of seed of oil and fibre plants (3), as last amended by Directive 81/126/EEC, and in particular Article 20a thereof,  Whereas, in the light of the development of scientific and technical knowledge, Annexes I and II to Directives 66/401/EEC and 69/208/EEC should be amended for the reasons set out below;  Whereas the conditions to be satisfied by the crop and by the seed, including the varietal purity standards, should be amended so as to conform with the schemes for the varietal certification of seed intended for international trade laid down by the Organization for Economic Cooperation and Development (OECD); whereas the dates for implementation laid down in the second indent of Article 2 of Commission Directive 78/386/EEC of 18 April 1978 amending the Annexes to Directive 66/401/EEC on the marketing of fodder plant seed (4), as last amended by Directive 81/126/EEC, and in the first indent of Article 2 (1) of Commission Directive 78/388/EEC of 18 April 1978 amending the Annexes to the Directive 69/208/EEC on the marketing of seed of oil and fibre plants (5), as last amended by Directive 81/126/EEC, should accordingly be adapted to the current situation;  Whereas it has not been possible in the present situation to provide for harmonization within the Community of the conditions in respect of minimum varietal purity standards which the crops or the seed must satisfy in the case of sunflower hybrids; whereas, however, an attempt is to be made before 1 July 1983 to establish these standards in order to achieve harmonization;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Annex I to Directive 66/401/EEC is hereby amended as follows:  1. In the second and third sentences of paragraph 4, the words 'Vicia faba' are added after the words 'Pisum sativum'.  2. In the second and third sentences of paragraph 4, the words 'Raphanus sativus ssp. oleifera' are deleted.  Article 2  Annex II to Directive 66/401/EEC is hereby amended as follows:  1. Paragraph 1 of Section I is replaced by the following:  'The seed shall have sufficient varietal identity and purity.  In particular, seeds of the species listed below shall conform to the following standards or other conditions. The minimum varietal purity shall be:  - Poa spp., apomictic uni-clonal varieties: 98 %,  - Pisum sativum, Vicia faba, Brassica napus var. napobrassica, Brassica oleracea conv. acephala:  - certified seed, 1st generation: 99 %,  - certified seed, 2nd and subsequent generations: 98 %.  The minimum varietal purity shall be examined mainly in field inspections carried out in accordance with the conditions laid down in Annex I.'  2. Paragraph 1 of Section II is replaced by the following:  'The seed of Pisum sativum, Brassica napus var. napobrassica, Brassica oleracea conv. acephala, Vicia faba and of apomictic uni-clonal varieties of Poa spp., shall conform to the following standards or other conditions:  The minimum varietal purity shall be 99;7 %.  The minimum varietal purity shall be examined mainly in field inspections carried out in accordance with the conditions laid down in Annex I.'  Article 3  Annex I to Directive 69/208/EEC is hereby amended as follows:  Paragraph 3 is replaced by the following:  'The crop shall have sufficient varietal identity and varietal purity.  In particular, crops of Brassica juncea, Brassica nigra, Cannabis sativa, Carum carvi and Gossypium sp., shall conform to the following standards:  The number of plants of the crop species which are recognizable as obviously not being true to the variety shall not exceed:  - one per 30 m2 for the production of basic seed,  - one per 10 m2 for the production of certified seed.'  Article 4  Annex II to Directive 69/208/EEC is hereby amended as follows:  Paragraph 1 of Section I is replaced by the following:  'The seed shall have sufficient varietal identity and varietal purity. In particular, seeds of the species listed below shall conform to the following standards or other conditions:  1.2 //   //   // Species and category  // Minimum varietal purity (%)  //   //   // 1  // 2  //   //   // Arachis hypogaea:  //   // - basic seed  // 99;7  // - certified seed  // 99;5  // Brassica napus ssp. oleifera, other than varieties for fodder purposes, Brassica rapa, other than varieties for fodder purposes  //   // - basic seed  // 99;9  // - certified seed  // 99;7  // Brassica napus ssp. oleifera, varieties for fodder purposes, Brassica rapa, varieties for fodder purposes, Helianthus annuus, other than hybrid varieties including their components, Sinapis alba:  //   // - basic seed  // 99;7  // - certified seed, 1st generation  // 99  // - certified seed, 2nd and subsequent generations  // 98  // Linum usitatissimum:  //  // - basic seed  // 99;7  // - certified seed, 1st generation  // 98  // - certified seed, 2nd and 3rd generations  // 97;5  // Papaver somniferum:  //   // - basic seed  // 99  // - certified seed  // 98  // Glycine max:  //   // - basic seed  // 97  // - certified seed  // 95  //   //  The minimum varietal purity shall be examined mainly in field inspections carried out in accordance with the conditions laid down in Annex I.'  Article 5  In the second indent of Article 2 (1) of Directive 78/386/EEC, 'on 1 January 1982' is hereby replaced by 'on a date to be determined at a later stage'. Article 6  In the first indent of Article 2 (1) of Directive 78/388/EEC, 'on 1 January 1982' is hereby replaced by 'on a date to be determined at a later stage'.  Article 7  1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with:  - the provisions of Article 5 and 6, with effect from 1 January 1982,  - the provisions of Article 2 in respect of Poa spp., with effect from 1 January 1983,  - the other provisions of this Directive, not later than 1 January 1983.  2. Member States shall ensure that seed is subject to no marketing restrictions on account of different dates of implementation of this Directive, in accordance with the third indent of paragraph 1.  Article 8  This Directive is addressed to the Member States.  Done at Brussels, 13 April 1982.  For the Commission  Poul DALSAGER  Member of the Commission  (1) OJ No 125, 11. 7. 1966, p. 2298/66.  (2) OJ No L 67, 12. 3. 1981, p. 36.  (3) OJ No L 169, 10. 7. 1969, p. 3.  (4) OJ No L 113, 25. 4. 1978, p. 1.  (5) OJ No L 113, 25. 4. 1978, p. 20.


Avis juridique important

|

31994L0013

Council Directive 94/13/EC of 29 March 1994 amending Directive 77/93/EEC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community

Official Journal L 092 , 09/04/1994 P. 0027 - 0030 Finnish special edition: Chapter 3 Volume 56 P. 0278  Swedish special edition: Chapter 3 Volume 56 P. 0278

COUNCIL DIRECTIVE 94/13/EC of 29 March 1994 amending Directive 77/93/EEC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the CommunityTHE  COUNCIL OF THE EUROPEAN UNION,  Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas Council Regulation (EEC) No 1911/91 of 26 June 1991 on the application of the provisions of Community law to the Canary Islands (4) integrates the Canary Islands into the Community's customs territory and into the common policies; whereas, under  Articles 2 and 10 of that Regulation, application of the common agricultural policy is subject to the entry into force of specific supply arrangements; whereas such application must also be accompanied by specific measures concerning agricultural  production;  Whereas Council Decision 91/314/EEC of 26 June 1991 setting up a programme of options specific to the remote and insular nature of the Canary Islands (Poseican) (5) outlines the options to be implemented to take account of the specific problems and  constraints faced by the Islands;  Whereas these measures involve the adaptation of Directive 77/93/EEC (6) to accommodate the specific plant health situation in the Canary Islands and to extend the application of certain measures of that Directive for a period expiring six months after  the date by which Member States must have implemented forthcoming provisions dealing with the Annexes to the Directive for the protection of the French overseas departments and of the Canary Islands;  Whereas it has become necessary to adapt the provisions relating to the derogations from the general rules provided for in Article 14 of Directive 77/93/EEC to the objectives of the internal market; whereas it is accordingly necessary to amend Articles  3, 4, 5, 6, 10 and 12 of the said Directive;  Whereas the provisions concerning additional requirements, referred to in Article 11 of Directive 77/93/EEC, are no longer compatible with the rules of the internal market, and should therefore be repealed,  HAS ADOPTED THIS DIRECTIVE:   Article 1  Directive 77/93/EEC is hereby amended as follows:  1. Article 1 shall be amended as follows:  (a) In paragraph 2 the words 'the Canary Islands' shall be deleted.  (b) The following paragraph shall be added after paragraph 3:  '3a This Directive shall also concern protective measures against the introduction of harmful organisms into the Canary Islands from other parts of Spain and, conversely, into other parts of Spain from the Canary Islands.' (c) In paragraph 4 the words 'and in the Canary Islands' shall be inserted after the words 'French overseas departments'.  (d) The following paragraphs shall be added after paragraph 6:  '7. In respect of the protective measures against the introduction of harmful organisms from the French overseas departments into other parts of France and into the other Member States and against their spread within the French overseas departments, the  dates referred to in Articles 1 (5), 3 (4), 4 (2) (a) and (4), 5 (2) and (4), 6 (4), (5) and (9), 10 (1), (2) (b) and (5) and 12 (6), (7) and (8) of this Directive shall be replaced by a date which corresponds to the end of a six-month period following  the date by which Member States must implement forthcoming provisions dealing with Annexes I to V to Directive 77/93/EEC for the protection of the French overseas departments. With effect from the same date paragraphs (3) and (4) shall be repealed.  8. In respect of the protective measures against the introduction of harmful organisms from the Canary Islands into other parts of Spain and into the other Member States and against their spread within the Canary Islands, the dates referred to in  Articles 1 (5), 3 (4), 4 (2) (a) and (4), 5 (2) and (4), 6 (4), (5) and (9), 10 (1), (2) (b) and (5) and 12 (6), (7) and (8) of this Directive shall be replaced by a date which corresponds to the end of a six-month period following the date by which  Member States must implement forthcoming provisions dealing with Annexes I to V to Directive 77/93/EEC for the protection of the Canary Islands. With effect from the same date paragraph 3a shall be repealed.' 2. Article 3 (7) shall be replaced by the following:  '7. (a) In accordance with the procedure laid down in Article 16a, it may be decided that Member States shall lay down that the introduction into their territories, and the spread within their territories, of specified organisms, whether singly or not,  which are considered to be harmful to plants or plant products but are not listed in Annexes I and II, shall be prohibited or require special authorization under conditions specified under the same procedure.  (b) In accordance with the procedure laid down in Article 16a, it may be decided that Member States shall lay down that the introduction into their territories, and the spread within their territories, of specified organisms, which are listed in Annex  II, but which occur on plants other that those listed in that Annex, and which are considered to be harmful to plants or plant products, shall be prohibited or require special authorization under conditions specified under the same procedure.  (c) In accordance with the procedure laid down in Article 16a, it may be decided that Member States shall lay down that the introduction into their territories, and the spread within their territories, of specified organisms, which are listed in Annexes  I and II, which are in an isolated state and which are considered to be harmful to plants or plant products, shall be prohibited or require special authorization under conditions specified under the same procedure.  (d) Subparagraphs (a), (b) and (c) shall also apply to such organisms where they are not affected by Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (7)() or other more  specific Community provisions regarding genetically modified organisms.  (e) Paragraphs 1 and 5 (a) and paragraphs 2 and 5 (b) shall not apply, in accordance with the conditions which shall be determined pursuant to the procedure laid down in Article 16a, for trial or scientific purposes and for work on varietal selections.   (f) After the measures provided for in subparagraphs (a), (b) and (c) have been adopted, those subparagraphs shall not apply, in accordance with conditions which shall be determined pursuant to the procedure laid down in Article 16a, for trial or  scientific purposes and for work on varietal selections.  ' 3. In Article 4 the following paragraphs shall be added after paragraph 4:  '5. Paragraphs 1 and 2 (a) shall not apply, in accordance with conditions which shall be determined pursuant to the procedure laid down in Article 16a, for trials or scientific purposes and for work on varietal selections.  6. (a) Provided that there is no risk of harmful organisms spreading, a Member State may provide that paragraphs 1 and 2 (a) shall not apply in individual specified cases to plants, plant products and other objects which are grown, produced or used in  its immediate frontier zone with a third country and introduced into that Member State in order to be worked in nearby locations in the frontier zone of its territory.  (b) When granting such a derogation, the Member State shall specify the location and the name of the person working it. Such details, which shall be updated regularly, shall be available to the Commission.  (c) Plants, plant products and other objects which form the subject of a derogation under subparagraph (a) shall be accompanied by documentary evidence of the location in the relevant third country from which the said plants, plant products and other  objects originate.' 4. Article 5 shall be amended as follows:  (a) In paragraph 4, the following sentence shall be added:  'This paragraph and paragraphs 1 and 2 shall not apply to the movement of small quantities of plants, plant products, foodstuffs or animal feedingstuffs where they are intended for use by the owner or recipient for non-industrial and non-commercial  purposes or for consumption during transport, provided that there is no risk of harmful organisms spreading.' (b) The following paragraphs shall be added after paragraph 4:  '5. Paragraphs 1, 2 and 4 shall not apply, in accordance with the conditions which shall be determined pursuant to the procedure laid down in Article 16a, for trial or scientific purposes and for work on varietal selections.  6. (a) Provided that there is no risk of harmful organisms spreading, a Member State may provide that paragraphs 1, 2 and 4 shall not apply in individual specified cases to plants, plant products and other objects which are grown, produced or used in  its immediate frontier zone with a third country and introduced into that Member State in order to be worked in nearby locations in the frontier zone of its territory.  (b) When granting such a derogation, the Member State shall specify the location and the name of the person working it. Such details which shall be updated regularly, shall be available to the Commission.  (c) Plants, plant products and other objects which form the subject of a derogation under subparagraph (a) shall be accompanied by documentary evidence of the location in the relevant third country from which the said plants, plant products and other  objects originate.' 5. Article 6 shall be amended as follows:  The following subparagraph shall be added to paragraph 4:  'Paragraphs 1, 2 and 3 shall not apply to the movement of small quantities of plants, plant products, foodstuffs or animal feedingstuffs where they are intended for use by the owner or recipient for non-industrial and non-commercial purposes or for  consumption during transport, provided that there is no risk of harmful organisms spreading.' 6. Article 10 shall be amended as follows:  In paragraph 2 the following subparagraph shall be added:  '(c) Paragraphs (a) and (b) shall not apply to the movement of small quantities of plants, plant products, foodstuffs or animal feedingstuffs where they are intended for use by the owner or recipient for non-industrial and non-commercial purposes or for  consumption during transport, provided that there is no risk of harmful organisms spreading.' 7. In Article 11 (2) the second subparagraph shall be deleted.  8. Article 12 shall be amended as follows:  (a) The following paragraphs shall be added after paragraph 3a:  '3b. provided that there is no risk of harmful organisms spreading:  - paragraphs 1 and 2 shall not apply where plants, plant products or other objects are directly moved between two places within the Community via the territory of a non-member country;  - paragraphs 1 and 2 and Article 4 (1) shall not apply in the case of transit through the territory of the Community;  - paragraphs 1 and 2 shall not apply in the case of small quantities of plants, plant products, foodstuffs or animal feedingstuffs where they are intended for use by the owner or recipient for non-industrial and non-commercial purposes or for  consumption during transport.  3c. Paragraphs 1 and 2 shall not apply, in accordance with the conditions which shall be determined pursuant to the procedure laid down in Article 16a, for trial or scientific purposes and for work on varietal selections.  3d. (i) Provided that there is no risk of harmful organisms spreading, a Member State may provide that paragraphs 1 and 2 shall not apply in individual specified cases to plants, plant products and other objects which are grown, produced or used in its  immediate frontier zone with a third country and introduced into that Member State in order to be worked in nearby locatins in the frontier zone of its territory.  (ii) When granting such a derogation, the Member State shall specify the location and the name of the person working it. Such details, which shall be updated regularly, shall be available to the Commission.  (iii) Plants, plant products and other objects which form the subject of a derogation under point (i) shall be accompanied by documentary evidence of the location in the relevant third country from which the said plants, plant products and other objects  originate.' (b) In paragraph 8, the following subparagraph shall be added:  'In the case of a removal referred to in first subparagraph, second indent, or a refusal referred to in the first subparagraph, fourth indent, the Member States shall lay down that the phytosanitary certificates or the reforwarding phytosanitary  certificates produced when the plant, plant products or other objects are submitted for introduction into their territory, be cancelled by the responsible official bodies referred to in Article 2 (1) (g). Upon cancellation, the said certificate shall  bear on its face and in a prominent position a triangular stamp in red, marked "certificate cancelled", from the said responsible bodies showing at least their name and the date of refusal. It shall be in capital letters, and in at least one of the  official languages of the Community.' 9. Article 14 shall be amended as follows:  (a) Paragraphs 1 and 2 shall be deleted.  (b) Former paragraph 3 shall become paragraph 1 and first subparagraph shall be replaced by the following:  '1. In accordance with the procedure laid down in Article 16, or, in urgent cases, with that laid down in Article 17, Member States may be authorized on request to provide for derogations:  - from Article 4 (1) with regard to Annex III, Part A and Part B without prejudice to the provisions of Article 4 (5) and from Article 5 (1) and the third indent of Article 12 (1) (a) with regard to other requirements referred to in Annex IV, Part A,  Section 1 and Annex IV, Part B;  - from Articles 7 (2) and 12 (1) (b), in the case of wood, if equivalent safeguards are given,  provided that it is established that the risk of spreading harmful organisms is obviated by one or more of the following factors:  - the origin of the plants or plant products,  - appropriate treatment,  - special precautions for the use of the plants or plant products.' (c) Former paragraph 4 shall become paragraph 2 and shall be replaced by the following:  '2. In the case of the derogations provided for in paragraph 1, an official statement that the conditions for granting the derogation are fulfilled shall be required for each individual case.' (d) Former paragraph 5 shall become paragraph 3 and shall be replaced by the following:  '3. Member States shall inform the Commission of the derogations which they have granted in accordance with paragraph 1. The Commission shall notify the other Member States of this information each year.  In accordance with the procedure laid down in Article 16, Member States may be exempted from providing this information.' (e) Paragraph 6 shall be deleted.   Article 2  The conditions referred to in Article 1 (2), Article 1 (3), Article 1 (4) (b) and Article 1 (8) shall be adopted by 1 September 1994.   Article 3  1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive by 1 January 1995. They shall forthwith inform the Commission thereof.  When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member  States.  2. Member States shall immediately communicate to the Commission all provisions of national law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof.   Article 4  This Directive is addressed to the Member States.  Done at Brussels, 29 March 1994.  For the Council The President G. MORAITIS  (1) OJ No C 97, 6. 4. 1993, p. 13.  (2) OJ No C 255, 20. 9. 1993, p. 242.  (3) OJ No C 201, 26. 7. 1993, p. 31.  (4) OJ No L 171, 29. 6. 1991, p. 1. Regulation as last amended by Regulation (EEC) No 284/92 (OJ No L 31, 7. 2. 1992, p. 6).  (5) OJ No L 171, 29. 6. 1991, p. 5.  (6) OJ No L 26, 31. 1. 1977, p. 20. Directive as last amended by Directive 92/103/EEC (OJ No L 363, 11. 12. 1992, p. 1).  (7)() OJ No L 117, 8. 5. 1990, p. 15.


title: Directive 2009/20/EC of the European Parliament and of the Council of 23 April 2009 on the insurance of shipowners for maritime claims (Text with EEA relevance)

text:
               28.5.2009

               EN

               Official Journal of the European Union

               L 131/128

      DIRECTIVE 2009/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 23 April 2009
   on the insurance of shipowners for maritime claims
   (Text with EEA relevance)
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Article 80(2) thereof,
   Having regard to the proposal from the Commission,
   Having regard to the opinion of the European Economic and Social Committee (1),
   Having regard to the opinion of the Committee of the Regions (2),
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),
   Whereas:

               (1)

               One element of Community maritime transport policy is to improve the quality of merchant shipping by making all economic operators act more responsibly.

               (2)

               Dissuasive measures have already been adopted under Directive 2005/35/EC of the European Parliament and of the Council of 7 September 2005 on ship source pollution and on the introduction of penalties for infringements (4).

               (3)

               On 9 October 2008, the Member States adopted a statement in which they unanimously recognised the importance of the application of the 1996 Protocol to the 1976 Convention on Limitation of Liability for Maritime Claims by all Member States.

               (4)

               The obligation to have insurance should make it possible to ensure better protection for victims. It should also help to eliminate substandard ships and make it possible to reestablish competition between operators. Furthermore, in Resolution A.898(21), the International Maritime Organisation invited States to urge shipowners to be properly insured.

               (5)

               Non compliance with the provisions of this Directive should be rectified. Directive 2009/16/EC of the European Parliament and of the Council of 23 April 2009 on port State control (recast) (5) already provides for the detention of ships in the case of absence of certificates which have to be carried on board. However, it is appropriate to provide for the possibility of expelling a ship which does not carry a certificate of insurance. The modalities of the expulsion should allow the situation to be rectified within a reasonable time period.

               (6)

               Since the objectives of this Directive, namely the introduction and implementation of appropriate measures in the field of maritime transport policy, cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale and effects, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   Subject matter
   This Directive lays down rules applicable to certain aspects of the obligations on shipowners as regards their insurance for maritime claims.
   Article 2
   Scope
   1.   This Directive shall apply to ships of 300 gross tonnage or more.
   2.   This Directive shall not apply to warships, auxiliary warships or other State owned or operated ships used for a non commercial public service.
   3.   This Directive shall be without prejudice to the regimes established by the instruments in force in the Member State concerned and listed in the Annex hereto.
   Article 3
   Definitions
   For the purpose of this Directive, the following definitions shall apply:

               (a)

               ‘shipowner’ means the registered owner of a seagoing ship, or any other person such as the bareboat charterer who is responsible for the operation of the ship;

               (b)

               ‘insurance’ means insurance with or without deductibles, and comprises, for example, indemnity insurance of the type currently provided by members of the International Group of P & I Clubs, and other effective forms of insurance (including proved self insurance) and financial security offering similar conditions of cover;

               (c)

               ‘1996 Convention’ means the consolidated text of the 1976 Convention on Limitation of Liability for Maritime Claims, adopted by the International Maritime Organisation (IMO), as amended by the 1996 Protocol.

         Article 4
   Insurance for maritime claims
   1.   Each Member State shall require that shipowners of ships flying its flag have insurance covering such ships.
   2.   Each Member State shall require shipowners of ships flying a flag other than its own to have insurance in place when such ships enter a port under the Member State's jurisdiction. This shall not prevent Member States, if in conformity with international law, from requiring compliance with that obligation when such ships are operating in their territorial waters.
   3.   The insurance referred to in paragraphs 1 and 2 shall cover maritime claims subject to limitation under the 1996 Convention. The amount of the insurance for each and every ship per incident shall be equal to the relevant maximum amount for the limitation of liability as laid down in the 1996 Convention.
   Article 5
   Inspections, compliance, expulsion from ports and denial of access to ports
   1.   Each Member State shall ensure that any inspection of a ship in a port under its jurisdiction in accordance with Directive 2009/16/EC, includes verification that a certificate referred to in Article 6 is carried on board.
   2.   If the certificate referred to in Article 6 is not carried on board, and without prejudice to Directive 2009/16/EC providing for detention of ships when safety issues are at stake, the competent authority may issue an expulsion order to the ship which shall be notified to the Commission, the other Member States and the flag State concerned. As a result of the issuing of such an expulsion order, every Member State shall refuse entry of this ship into any of its ports until the shipowner notifies the certificate referred to in Article 6.
   Article 6
   Insurance certificates
   1.   The existence of the insurance referred to in Article 4 shall be proved by one or more certificates issued by its provider and carried on board the ship.
   2.   The certificates issued by the insurance provider shall include the following information:

               (a)

               name of ship, its IMO number, and port of registry;

               (b)

               shipowner’s name and principal place of business;

               (c)

               type and duration of the insurance;

               (d)

               name and principal place of business of the provider of the insurance and, where appropriate, the place of business where the insurance is established.

         3.   If the language used in the certificates is neither English nor French nor Spanish, the text shall include a translation into one of these languages.
   Article 7
   Penalties
   For the purposes of Article 4(1), Member States shall lay down a system of penalties for the breach of national provisions adopted pursuant to this Directive and shall take all the measures necessary to ensure that those penalties are applied. The penalties provided for shall be effective, proportionate and dissuasive.
   Article 8
   Reports
   Every three years, and for the first time before 1 January 2015, the Commission shall present a report to the European Parliament and to the Council on the application of this Directive.
   Article 9
   Transposition
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 2012. They shall forthwith inform the Commission thereof.
   When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
   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 10
   Entry into force
   This Directive shall enter into force on the day following its publication in the Official Journal of the European Union.
   Article 11
   Addressees
   This Directive is addressed to the Member States.

      Done at Strasbourg, 23 April 2009.

            For the European Parliament

            The President

         H.-G. PÖTTERING

            For the Council

            The President

         P. NEČAS

      (1)  OJ C 318, 23.12.2006, p. 195.

      (2)  OJ C 229, 22.9.2006, p. 38.

      (3)  Opinion of the European Parliament of 29 March 2007 (OJ C 27 E, 31.1.2008, p. 166), Council Common Position of 9 December 2008 (OJ C 330 E, 30.12.2008, p. 7) and Position of the European Parliament of 11 March 2009 (not yet published in the Official Journal).

      (4)  OJ L 255, 30.9.2005, p. 11.

      (5)  See page 57 of this Official Journal.

      ANNEX

                  —

                  The International Convention on Civil Liability for Oil Pollution Damage, 1992.

                  —

                  The International Convention on Liability and Compensation for Damage in Connection with the Carriage of Hazardous and Noxious Substances by Sea, 1996 (HNS Convention).

                  —

                  The International Convention on Civil Liability for Bunker Oil Pollution Damage, 2001 (‘Bunker Oil’ Convention).

                  —

                  The Nairobi International Convention on the Removal of Wrecks, 2007 (‘Wrecks Removal’ Convention).

                  —

                  Regulation (EC) No 392/2009 of the European Parliament and of the Council of 23 April 2009 on the liability of carriers of passengers by sea in the event of accidents.


title: Commission Directive 2010/2/EU of 27 January 2010 amending Council Directive 91/414/EEC as regards an extension of the use of the active substance chlormequat (Text with EEA relevance)

text:
               28.1.2010

               EN

               Official Journal of the European Union

               L 24/11

         COMMISSION DIRECTIVE 2010/2/EU
   of 27 January 2010
   amending Council Directive 91/414/EEC as regards an extension of the use of the active substance chlormequat
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular the second indent of the second subparagraph of Article 6(1) thereof,
   Whereas:

               (1)

               By Commission Directive 2009/37/EC (2) chlormequat was included as active substance in Annex I to Directive 91/414/CEE.

               (2)

               When applying for the inclusion of chlormequat its notifier the CCC Task Force submitted data on uses as plant growth regulator which supported the overall conclusion that it may be expected that plant protection products containing chlormequat will fulfil the safety requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC. However, chlormequat was included in Annex I to that Directive with the specific provision that Member States may only authorise uses on cereals.

               (3)

               In addition to that use, Belgium and Sweden now have applied for an amendment to this specific provision to allow chlormequat to be used on ornamentals and grass for seed, respectively. These Member States informed the Commission on 29 October 2009 and 4 November 2009 about their conclusions that the requested extensions of use do not cause any risks in addition to those already taken into account in the specific provisions for chlormequat in Annex I to Directive 91/414/EEC and in the Commission review report for that substance. In particular, the extensions concern applications on non-edible crops and, as a consequence, no residues in food will occur. Furthermore, the other application parameters, as set out in the specific provisions of Annex I to Directive 91/414/EEC, remain unchanged.

               (4)

               Therefore it is justified to modify the specific provisions for chlormequat.

               (5)

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

               (6)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   Member States shall adopt and publish by 28 May 2010 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 29 May 2010.
   When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 3
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 27 January 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 104, 24.4.2009, p. 23.

      ANNEX
      In Annex I to Directive 91/414/EEC, row 281 is replaced by the following:

                     No

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘281

                     chlormequat
                     CAS No 7003-89-6 (chlormequat)
                     CAS No 999-81-5 (chlormequat chloride)
                     CIPAC No 143 (chlormequat)
                     CIPAC No 143.302 (chlormequat chloride)

                        2-chloroethyltrimethylammonium (chlormequat)

                        2-chloroethyltrimethylammonium chloride

                        (chlormequat chloride)

                     ≥ 636 g/kg
                     Impurities
                     1,2-dichloroethane: max 0,1 g/kg (on the dry chlormequat chloride content)
                     Chloroethene (vinylchloride): max 0,0005 g/kg (on the dry chlormequat chloride content)

                     1 December 2009

                     30 November 2019

                     PART A
                     Only uses as plant growth regulator on cereals and non edible crops may be authorised.
                     PART B
                     In assessing applications to authorise plant protection products containing chlormequat for uses other than in rye and triticale, notably as regards the exposure of consumers, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on chlormequat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

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

                                 —

                                 the protection of birds and mammals.

                           Conditions of authorisation shall include risk mitigation measures, where appropriate.
                     The Member States concerned shall request the submission of further information on the fate and behaviour (adsorption studies to be performed at 20 °C, recalculation of the predicted concentrations in groundwater, surface water and sediment), the monitoring methods for determination of the substance in animal products and water, and the risk to aquatic organisms, birds and mammals. They shall ensure that the notifier at whose request chlormequat has been included in this Annex provide such information to the Commission by 30 November 2011 at the latest.’

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


Important legal notice

|

32003L0057

Commission Directive 2003/57/EC of 17 June 2003 amending Directive 2002/ 32/EC of the European Parliament and of the Council on undesirable substances in animal feedText with EEA relevance

Official Journal L 151 , 19/06/2003 P. 0038 - 0041

Commission Directive 2003/57/ECof 17 June 2003amending Directive 2002/32/EC of the European Parliament and of the Council on undesirable substances in animal feed(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed(1), and in particular Article 8(1) thereof,Whereas:(1) Council Directive 1999/29/EC on the undesirable substances and products in animal nutrition(2), as amended by Directive 2001/102/EC(3), establishes maximum levels for dioxins in several feed materials and compound feedingstuffs.(2) Directive 2002/32/EC repeals and replaces Directive 1999/29/EC with effect from 1 August 2003.(3) It is of major importance for public and animal health protection that the maximum levels for dioxins established by Directive 1999/29/EC remain in force after 1 August 2003. Directive 2002/32/EC should therefore be amended in order to include the maximum levels for dioxins, established by Directive 1999/29/EC.(4) In order to avoid any confusion it is appropriate to specify that minerals refer to the feed materials in the meaning of the Annex of Council Directive 96/25/EC of 29 April 1996 on the circulation and use of feed materials(4) as last amended by Directive 2001/46/EC of the European Parliament and of the Council(5).(5) For greater clarity the rules governing dioxins should be collected in a single text. As a result, it is appropriate to amend Directive 2002/32/EC by inserting as an annex thereto the provisions of Commission Regulation (EC) No 2439/1999 of 17 November 1999 on the conditions for the authorisation of additives belonging to the group "binders, anti-caking agents and coagulants" in feedingstuffs(6), as amended by Regulation (EC) No 739/2000(7), which establishes a provisional maximum limit for kaolinitic clays and other additives authorised for use as binders, anti-caking agents and coagulants. As no or insufficient monitoring data on the presence of dioxins have been provided for calcium sulphate dihydrate, vermiculite, natrolite-phonolite, synthetic calcium aluminates and clinoptilolite of sedimentary origin demonstrating the absence of contamination by dioxins or contamination at levels below the limit of quantification, it is therefore appropriate in order to protect animal and human health to establish for these additives a maximum level for dioxins in addition to the maximum level for dioxins in kaolinitic clay. As a result, Regulation (EC) 2439/1999 can be repealed.(6) 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 1Annex I to Directive 2002/32/EC is hereby amended in accordance with the Annex to this Directive.Article 21. With exception of the provisions concerning the entries (c) and (j) in the list of products in the table annexed to this Directive, Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 July 2003 at the latest. They shall forthwith inform the Commission thereof. They shall apply these provisions from 1 August 2003.With regard to the provisions concerning the entries (c) and (j) in the list of products in the table annexed to this Directive, Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 29 February 2004 at the latest. They shall forthwith inform the Commission thereof. They shall apply these provisions from 1 March 2004.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 texts of the provisions of national law, which they adopt in the field covered by this Directive.Article 3Commission Regulation (EC) No 2439/1999 of 17 November 1999 on the conditions for the authorisation of additives belonging to the group "binders, anti-caking agents and coagulants" in feedingstuffs shall be repealed with effect from 1 March 2004.Article 4This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.Article 5This Directive is addressed to the Member States.Done at Brussels, 17 June 2003.For the CommissionDavid ByrneMember of the Commission(1) OJ L 140, 30.5.2002, p. 10.(2) OJ L 115, 4.5.1999, p. 32.(3) OJ L 6, 10.1.2002, p. 45.(4) OJ L 125, 23.5.1996, p. 35.(5) OJ L 234, 1.9.2001, p. 55.(6) OJ L 297, 18.11.1999, p. 8.(7) OJ L 87, 8.4.2000, p. 14.ANNEXAnnex I to Directive 2002/32/EC is amended as follows:(a) in the table, point 27 shall be replaced by the following:">TABLE>"(b) at the end of Annex I, footnote (5) is deleted and the following footnotes shall be added:"(5) Upper-bound concentrations; upper-bound concentrations are calculated assuming that all values of the different congeners less than the limit of quantification are equal to the limit of quantification.(6) These maximum limits shall be reviewed for the first time before 31 December 2004 in the light of new data on the presence of dioxins and dioxin-like PCBs, in particular with a view to the inclusion of dioxin-like PCBs in the levels to be set and will be further reviewed before 31 December 2006 with the aim of significantly reducing of the maximum levels.(7) Fresh fish directly delivered and used without intermediate processing for the production of feedingstuffs for fur animals is exempted from the maximum limit and a maximum level of 4,0 ng WHO-PCDD/F-TEQ/kg product is applicable to fresh fish used for the direct feeding of pet animals, zoo and circus animals. The products, processed animal proteins produced from these animals (fur animals, pet animals, zoo and circus animals) cannot enter the food chain and the feeding thereof is prohibited to farmed animals which are kept, fattened or bred for the production of food."