title: Commission Directive 2006/131/EC of 11 December 2006 amending Council Directive 91/414/EEC to include methamidophos as an active substance   (Text with EEA relevance)

text:
               12.12.2006

               EN

               Official Journal of the European Union

               L 349/17

      COMMISSION DIRECTIVE 2006/131/EC
   of 11 December 2006
   amending Council Directive 91/414/EEC to include methamidophos as an active substance
   (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 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 (2), establishes 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 methamidophos.

               (2)

               For methamidophos the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulation (EEC) No 3600/92 for a range of uses proposed by the notifier. By Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protection products and designating the Rapporteur Member State for the implementation of Commission Regulation (EEC) No 3600/92 (3), Italy was designated as Rapporteur Member State. Italy submitted on 30 July 1999 the relevant assessment report and recommendations to the Commission in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92.

               (3)

               The assessment report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health.

               (4)

               The review of methamidophos revealed a number of open questions which were addressed by the Scientific Panel on Plant health, Plant protection products and their Residues (PPR) of the European Food Safety Authority (EFSA). The Scientific Panel was asked to define a value for the degree of dermal adsorption scientifically based on the different results of the studies submitted by the notifier to be used in the assessment of human risk arising from the dermal route of exposure. Moreover, the Scientific Panel was asked to review the estimates of avoidance, time spent foraging in treated areas and proportion of contaminated diet obtained in treated areas, and advise on their implications for estimates of acute, short and long term exposure of birds and mammals to the insecticide methamidophos. In its opinion on the first question the PPR Panel concluded (4) that, on the basis of the available data the best estimated dermal adsorption of the diluted preparation is considered to be about 5 %. On the second question, the PPR Panel concentrated its assessment on two species considered by the notifier and Rapporteur Member State, yellow wagtail and wood mouse, as they make substantial use of the crops supported for methamidophos. The PPR Panel disagreed (5) with the values proposed by the notifier and the Rapporteur Member State as regards the proportion of contaminated diet set for yellow wagtails and the estimates used in dietary composition for yellow wagtails and wood mouse. The PPR Panel noted that these values would underestimate acute exposure of individual animals. The PPR Panel developed an alternative approach for assessing the potential role of avoidance. The mechanisms involved are complex but it appears possible that both yellow wagtail and wood mouse might feed quickly enough for mortality to occur in field conditions. The PPR Panel identified several options for laboratory or field studies, which could be considered to assess these risks with more certainty.

               (5)

               Articles 5(4) and 6(1) of Directive 91/414/EEC provide that inclusion of a substance in Annex I may be subject to restrictions and conditions. In this case, restrictions on the inclusion period and on the authorised crops are deemed necessary. The original measures presented to the Standing Committee on the Food Chain and Animal Health, proposed the restriction of the inclusion period to seven years, so that Member States would give priority to reviewing plant protection products already on the market containing methamidophos. In order to avoid discrepancies in the high level of protection sought, the inclusion in Annex I to Directive 91/414/EEC was intended to be limited to the uses of methamidophos that have been actually assessed within the Community evaluation and for which the proposed uses were considered to comply with the conditions of Directive 91/414/EEC. This implies that other uses, which were not or only partially covered by this assessment, had first to be subject to a complete assessment, before their inclusion in Annex I of Directive 91/414/EEC could be considered. Finally, due to the hazardous nature of methamidophos, it was considered necessary to provide for a minimum harmonisation at Community level of certain risk mitigation measures that were to be applied by Member States when granting authorisations.

               (6)

               Under the procedures laid down by Directive 91/414/EEC, the approval of active substances, including the definition of risk management measures, is decided by the Commission. Member States bear the responsibility for the implementation, application and control of the measures intended to mitigate the risks generated by plant protection products. Concerns expressed by several Member States reflect their judgment that additional restrictions are necessary to reduce the risk to a level that can be considered acceptable and consistent with the high level of protection that is sought within the Community. At present, it is a question of risk management to set the adequate level of safety and protection for the continued production, commercialisation and use of methamidophos.

               (7)

               As a consequence of the above, the Commission re-examined its position. In order to correctly reflect the high level of protection of human and animal health and a sustainable environment sought in the Community, it considered appropriate, in addition to the principles set out in Recital 5, to further reduce the period of inclusion to 18 months instead of seven years. This further reduces any risk by ensuring a priority re-assessment of this substance.

               (8)

               It may be expected that plant protection products containing methamidophos satisfy the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, with regard to the uses which were examined and detailed in the Commission review report and providing that the necessary risk mitigation measures are applied.

               (9)

               Without prejudice to the conclusion that plant protection products containing methamidophos may be expected to satisfy the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, 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 methamidophos should be subjected to further testing for confirmation of the risk assessment for birds and mammals and that such studies should be presented by the notifiers. In addition, Member States should require authorisation holders to provide information on the use of methamidophos including any information on incidences on operator health.

               (10)

               As with all substances included in Annex I to Directive 91/414/EEC, the status of methamidophos could be reviewed under Article 5(5) of that Directive in the light of any new data becoming available. Equally, the fact that the inclusion of this substance in Annex I expires on a particular date does not prevent the inclusion being renewed according to the procedures laid down in the Directive.

               (11)

               The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Regulation (EEC) No 3600/92 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.

               (12)

               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.

               (13)

               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 methamidophos 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. Given the hazardous properties of methamidophos, the period for Member States to verify whether the plant protection products, which contain methamidophos as the only active substance or in combination with other authorised active substances, comply with the provisions of Annex VI should not exceed 18 months.

               (14)

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

               (15)

               The measures provided for in this Directive are not in accordance with the opinion delivered by the Standing Committee on the Food Chain and Animal Health. The Commission therefore submitted to the Council a proposal relating to these measures. On the expiry of the period laid down in the second subparagraph of Article 19(2) of Directive 91/414/EEC, the Council had neither adopted the proposed implementing act nor indicated its opposition to the proposal for implementing measures and it is accordingly for the Commission to adopt these measures,

         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 30 June 2007 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 July 2007.
   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 methamidophos as an active substance by 30 June 2007.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to methamidophos 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.
   2.   By derogation from paragraph 1, for each authorised plant protection product containing methamidophos, 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 methamidophos. 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 for products containing methamidophos, where necessary amend or withdraw the authorisation by 30 June 2008.
   Article 4
   This Directive shall enter into force on 1 January 2007.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 11 December 2006.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2006/85/EC (OJ L 293, 24.10.2006, p. 3).

      (2)  OJ L 366, 15.12.1992, p. 10. Regulation as last amended by Regulation (EC) No 2266/2000 (OJ L 259, 13.10.2000, p. 10).

      (3)  OJ L 107, 28.4.1994, p. 8. Regulation as last amended by Regulation (EC) No 2230/95 (OJ L 225, 22.9.1995, p. 1).

      (4)  Opinion of the Scientific Panel on Plant Health, Plant Protection Products and their Residues on a request from the Commission related to the evaluation of methamidophos in toxicology in the context of Council Directive 91/414/EEC (The EFSA Journal (2004), 95, 1 to 15). Adopted on 14 September 2004.

      (5)  Opinion of the Scientific Panel on Plant Health, Plant Protection Products and their Residues on a request from the Commission related to the evaluation of methamidophos in ecotoxicology in the context of Council Directive 91/414/EEC (The EFSA Journal (2004), 144, 1 to 50). Adopted on 14 December 2004.

      ANNEX
      The following entries 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

                     ‘145

                     Methamidophos
                     CAS No 10265-92-6
                     CIPAC No 355

                     O,S-dimethyl phosphoramidothioate

                     ≥ 680 g/kg

                     1 January 2007

                     30 June 2008

                     PART A
                     Only use as insecticide on potato may be authorised.
                     The following conditions of use must be respected:

                                 —

                                 At rates not exceeding 0,5 kg active substance per hectare per application,

                                 —

                                 Maximum 3 applications per season.

                           The following uses must not be authorised:

                                 —

                                 air application,

                                 —

                                 knapsack and all hand-held applications, neither by amateur nor by professional users,

                                 —

                                 home gardening.

                           Member States shall ensure that all appropriate risk mitigation measures are applied. Particular attention must be paid to the protection of:

                                 —

                                 birds and mammals. Conditions of authorisation shall include risk mitigation measures, such as a judicious timing of the application and the selection of those formulations which, as a result of their physical presentation or the presence of agents that ensure an adequate avoidance, minimise the exposure of the concerned species,

                                 —

                                 aquatic organisms and non-target arthropods. An appropriate distance must be kept between treated areas and surface water bodies as well as margins of the crop. This distance may depend on the application or not of drift reducing techniques,

                                 —

                                 operators, who must wear suitable protective clothing, in particular gloves, coveralls, rubber boots and respiratory protective devices during mixing-loading and gloves, coveralls, rubber boots and face protection or safety glasses during application and cleaning of equipment. The above measures must be applied, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment.

                           PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on methamidophos, and in particular Appendices I and II thereof, shall be taken into account.
                     Member States must ensure that the authorisation holders report at the latest on 31 December of each year on any reported effect on operator health. Member States may require that elements, such as sales data and a survey of use patterns, are provided so that a realistic picture of the use conditions and the possible toxicological impact of methamidophos can be obtained.
                     Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals. They shall ensure that the notifiers at whose request methamidophos has been included in this Annex provide such studies to the Commission within 1 year from the entry into force of this Directive.’

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


title: Commission Directive 2007/5/EC of 7 February 2007 amending Council Directive 91/414/EEC to include captan, folpet, formetanate and methiocarb as active substances (Text with EEA relevance )

text:
               8.2.2007

               EN

               Official Journal of the European Union

               L 35/11

      COMMISSION DIRECTIVE 2007/5/EC
   of 7 February 2007
   amending Council Directive 91/414/EEC to include captan, folpet, formetanate and methiocarb 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 703/2001 (3) lay down the detailed rules for the implementation of the second 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 captan, folpet, formetanate and methiocarb.

               (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 703/2001 for a range of uses proposed by the notifier. 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 8(1) of Regulation (EC) No 451/2000. For captan, folpet and formetanate, the rapporteur Member State was Italy and all relevant information was submitted on 20 October 2003 for captan and folpet and on 13 July 2004 for formetanate. For methiocarb the rapporteur Member State was United Kingdom and all relevant information was submitted on 4 March 2004.

               (3)

               The assessment reports have been peer reviewed by the Member States and the EFSA and presented to the Commission on 24 April 2006 for captan, folpet and formetanate and on 12 May 2006 for methiocarb 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 29 September 2006 in the format of the Commission review reports for captan, folpet, formetanate and methiocarb.

               (4)

               It has appeared from the various examinations made that plant protection products containing captan, folpet, formetanate and methiocarb 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 concerning captan, folpet, formetanate and methiocarb. 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 captan, folpet, formetanate and methiocarb should be subjected to further testing for confirmation of the risk assessment for some issues and that such studies should be presented by the notifiers.

               (6)

               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.

               (7)

               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 captan, folpet, formetanate and methiocarb 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.

               (8)

               The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Regulation (EEC) No 3600/92 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.

               (9)

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

               (10)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   Member States shall adopt and publish by 31 March 2008 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 April 2008.
   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 captan, folpet, formetanate and methiocarb as active substances by 31 March 2008.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to captan, folpet, formetanate and methiocarb 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 captan, folpet, formetanate and methiocarb 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 September 2007 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 captan, folpet, formetanate and methiocarb 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 captan, folpet, formetanate and methiocarb as the only active substance, where necessary, amend or withdraw the authorisation by 30 September 2011 at the latest; or

               (b)

               in the case of a product containing captan, folpet, formetanate and methiocarb as one of several active substances, where necessary, amend or withdraw the authorisation by 30 September 2011 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 October 2007.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 7 February 2007.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2006/136/EC (OJ L 349, 12.12.2006, p. 42).

      (2)  OJ L 55, 29.2.2000, p. 25. Regulation as last amended by Regulation (EC) No 1044/2003 (OJ L 151, 19.6.2003, p. 32).

      (3)  OJ L 98, 7.4.2001, p. 6.

      (4)  EFSA Scientific Report (2006) 71, 1-89, Conclusion regarding the Peer review of the pesticide risk assessment of the active substance captan (finalised: 24 April 2006)
   EFSA Scientific Report (2006) 70, 1-78, Conclusion regarding the Peer review of the pesticide risk assessment of the active substance folpet (finalised: 24 April 2006)
   EFSA Scientific Report (2006) 69, 1-78, Conclusion regarding the Peer review of the pesticide risk assessment of the active substance formetanate (finalised: 24 April 2006)
   EFSA Scientific Report (2006) 79, 1-82, Conclusions on the peer review of methiocarb (finalised: 12 May 2006).

      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

                     ‘151

                     Captan
                     CAS No 133-06-02
                     CIPAC No 40

                     N-(trichloromethylthio)cyclohex-4-ene-1,2-dicarboximide

                     ≥ 910 g/kg
                     Impurities:

                                 Perchloromethylmercaptan (R005406): not more than 5 g/kg

                                 Folpet: not more than 10 g/kg

                                 Carbon tetrachloride not more than 0,01 g/kg

                     1 October 2007

                     30 September 2017

                     PART A
                     Only uses as fungicide can be authorised.
                     PART B
                     In assessing applications to authorise plant protection products containing captan for uses other than tomatoes 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 captan, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

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

                                 —

                                 the dietary exposure of consumers in view of future revisions of Maximum Residue Levels;

                                 —

                                 the protection of groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated in vulnerable zones, where appropriate;

                                 —

                                 the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures.

                           The Member States concerned shall request the submission of further studies to confirm the long term risk assessment for birds and mammals, as well as the toxicological assessment on metabolites potentially present in groundwater under vulnerable conditions. They shall ensure that the notifiers at whose request captan has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.

                     152

                     Folpet
                     CAS No 133-07-3
                     CIPAC No 75

                     N-(trichloromethylthio)phthalimide

                     ≥ 940 g/kg
                     Impurities:

                                 Perchloromethylmercaptan (R005406): not more than 3,5 g/kg

                                 Carbon tetrachloride not more than 4 g/kg

                     1 October 2007

                     30 September 2017

                     PART A
                     Only uses as fungicide can be authorised.
                     PART B
                     In assessing applications to authorise plant protection products containing folpet for uses other than winter wheat 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 folpet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

                                 operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment;

                                 —

                                 the dietary exposure of consumers in view of future revisions of Maximum Residue Levels;

                                 —

                                 the protection of birds, mammals, aquatic and soil organisms. Conditions of authorisation should include risk mitigation measures.

                           The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and earthworms. They shall ensure that the notifiers at whose request folpet has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.

                     153

                     Formetanate
                     CAS No 23422-53-9
                     CIPAC No 697

                     3-dimethylaminomethyleneaminophenyl methylcarbamate

                     ≥ 910 g/kg

                     1 October 2007

                     30 September 2017

                     PART A
                     Only uses as insecticide and acaricide may be authorised.
                     PART B
                     In assessing applications to authorise plant protection products containing formetanate for uses other than in field tomatoes and ornamental shrubs 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 formetanate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.
                     In this overall assessment Member States:

                                 —

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

                                 —

                                 must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;

                                 —

                                 must pay particular attention to the dietary exposure of consumers in view of future revisions of Maximum Residue Levels.

                           The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and non-target arthropods. They shall ensure that the notifier at whose request formetanate has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.

                     154

                     Methiocarb
                     CAS No 2032-65-7
                     CIPAC No 165

                     4-methylthio-3,5-xylyl methylcarbamate

                     ≥ 980 g/kg

                     1 October 2007

                     30 September 2017

                     PART A
                     Only uses as repellent in seed treatment, insecticide and molluscicide may be authorised.
                     PART B
                     In assessing applications to authorise plant protection products containing methiocarb for uses other than seed treatment in maize 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 methiocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.
                     In this overall assessment Member States:

                                 —

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

                                 —

                                 must pay particular attention to the operator and bystander safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;

                                 —

                                 must pay particular attention to the dietary exposure of consumers in view of future revisions of Maximum Residue Levels.

                           The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and non-target arthropods, as well as to confirm the toxicological assessment on metabolites potentially present in crops. They shall ensure that the notifier at whose request methiocarb has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.’

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


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31998L0009

Council Directive 98/9/EC of 20 January 1998 on the list of less-favoured farming areas within the meaning of Regulation (EC) No 950/97 (Denmark)

Official Journal L 022 , 29/01/1998 P. 0021 - 0022

COUNCIL DIRECTIVE 98/9/EC of 20 January 1998 on the list of less-favoured farming areas within the meaning of Regulation (EC) No 950/97 (Denmark)THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community,Having regard to Council Regulation (EC) No 950/97 of 20 May 1997 on improving the efficiency of agricultural structures (1), and in particular Article 21(2) thereof,Having regard to the proposal from the Commission (2),Having regard to the opinion of the European Parliament (3),Whereas the permanent natural and geographical handicaps existing in the Danish islands result in higher production and transport costs which prevent farmers in these areas from obtaining, from their production, income on a level with that obtained by comparable farmers elsewhere in the Member State;Whereas the Danish Government has sent the Commission, in accordance with Article 21(1) of Regulation (EC) No 950/97, a list of islands suitable for inclusion in the Community list of less-favoured farming areas and information on the particular features of these areas;Whereas, with a view to identifying the areas affected by specific handicaps that can be deemed less-favoured areas as referred to in Article 25 of Regulation (EC) No 950/97, all islands with an area of less than 600 km2 on which adverse natural conditions contribute to a farming income below the national average have been selected;Whereas the total surface area of the relevant areas does not exceed 4 % of the total surface area of the Member State in question;Whereas the nature and level of the above indices used by the Government of Denmark to define the areas notified to the Commission correspond to the characteristics of the areas affected by specific handicaps referred to in Article 25 of Regulation (EC) No 950/97,HAS ADOPTED THIS DIRECTIVE:Article 1 The list of less-favoured farming areas in Denmark shall be that contained in the Annex to this Directive. They shall be included in the Community list of less-favoured farming areas within the meaning of Article 25 of Regulation (EC) No 950/97.Article 2 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.Article 3 This Directive is addressed to the Kingdom of Denmark.Done at Brussels, 20 January 1998.For the CouncilThe PresidentJ. CUNNINGHAM(1) OJ L 142, 2. 6. 1997, p. 1.(2) OJ C 372, 9. 12. 1997, p. 21.(3) Opinion delivered on 14 January 1998 (not yet published in the Official Journal).ANNEX >TABLE>


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31976L0116

Council Directive 76/116/EEC of 18 December 1975 on the approximation of the laws of the Member States relating to fertilizers

Official Journal L 024 , 30/01/1976 P. 0021 - 0044 Finnish special edition: Chapter 13 Volume 4 P. 0193  Greek special edition: Chapter 13 Volume 3 P. 0164  Swedish special edition: Chapter 13 Volume 4 P. 0193  Spanish special edition: Chapter 13 Volume 4 P. 0204  Portuguese special edition Chapter 13 Volume 4 P. 0204

COUNCIL DIRECTIVE  of 18 December 1975  on the approximation of the laws of the Member States relating to fertilizers  (76/116/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,  Having regard to the proposal from the Commission,  Having regard to the opinion of the European Parliament (1),  Having regard to the opinion of the Economic and Social Committee (2),  Whereas in each Member State fertilizers must display certain technical characteristics laid down by mandatory provisions ; whereas these provisions, concerning more particularly the composition and definition of fertilizer types, the designations of these types, their identification and their packaging, differ from one Member State to another ; whereas by their disparity they hinder trade within the European Economic Community;  Whereas these obstacles to the establishment and functioning of the common market can be reduced or even removed if the same provisions are adopted by all the Member States, either in addition to or in place of their present laws;  Whereas it is necessary to this end to determine at Community level the designation, definition and composition of the principal straight and compound fertilizers in the Community ; whereas it should likewise be provided that fertilizers satisfying the criteria laid down by this Directive be marked "EEC fertilizer";  Whereas Community rules on the identification and labelling of these fertilizers, and on the closure of the containers, should also be laid down;  Whereas the production of fertilizers is subject to varying degress of fluctuation due to manufacturing techniques or basic materials ; whereas, sampling and analytical procedures may also contain variations ; whereas, on these accounts, it is necessary to authorize tolerances on the declared nutrient contents ; whereas it is advisable, in the interest of the agricultural user, to keep these tolerances within narrow limits;  Whereas this Directive concerns only straight and compound fertilizers ; whereas subsequent Directives will lay down provisions relating, inter alia, to liquid fertilizers, secondary elements and trace elements;  Whereas the determination of the sampling techniques and the methods of analysis, as well as any changes or additions to be made thereto in consideration of technical progress, are implementing measures of a technical nature, and whereas it is appropriate to assign their adoption to the Commission in order to simplify and speed up the procedure;  Whereas technical progress necessitates the rapid adaptation of the technical requirements defined in the various Directives relating to fertilizers ; whereas, in order to facilitate the implementation of the measures required for this purpose, it is advisable to provide for a procedure establishing close cooperation between the Member States and the Commission within the Committee on the adjustment to technical progress of Directives which concern the abolition of technical barriers to trade in fertilizers,  HAS ADOPTED THIS DIRECTIVE:    Article 1 This Directive shall apply to products which are marketed as fertilizers and designated "EEC fertilizer".   Article 2 Member States shall take all the necessary measures to ensure that the designation "EEC fertilizer" may  (1)OJ No C 49, 28.6.1973, p. 42. (2)OJ No C 123, 27.11.1972, p. 34.    only be used for fertilizers belonging to one of the solid fertilizer types listed in Annex I and complying with the conditions laid down by the Directive and Annexes I to III thereto.   Article 3 Member States shall take all the necessary measures to ensure that the fertilizers referred to in Article 1 are provided with identification markings. These identification markings are listed under paragraph 1 of Annex II and the terms and conditions governing the application of these markings are set out under paragraph 2 of the same Annex.  If the fertilizers are packed, these markings must appear on the packages or labels. For containers with a quantity of fertilizer exceeding 100 kg, these markings need appear only on the accompanying documents. If the fertilizers are in bulk, these markings must appear on the accompanying documents.  In order to satisfy the requirements of Annex II, paragraph 1 (b) and (c), Member States may prescribe that for fertilizers marketed in their territories, indication of the phosphorus, potassium and magnesium contents shall be expressed:    - solely in the oxide form (P2O5, K2O, MgO),       - or solely in the elemental form (P, K, Mg),       - or in both these forms simultaneously.         Where Member States exercise the option to prescribe that the phosphorus, potassium and magnesium contents be expressed in the form of elements, all references in the Annexes to the oxide form shall be expressed in elemental form and the numerical values converted using the following factors:  phosphorus pentoxide (P2O5) X 0 7436 = phosphorus (P);  potassium oxide (K2O) X 0 783 = potassium (K);  magnesium oxide (MgO) X 0 76 = magnesium(Mg).  Member States who have exercised the said option shall make the necessary adaptations to the provisions contained in the Annexes to this Directive.   Article 4 1. Without prejudice to other Community rules, the only markings permitted on the packages, labels and accompanying documents referred to in Article 3 shall be the following indications relating to fertilizers:    (a) the compulsory identification markings specified in paragraph 1 of Annex II;       (b) the optional data listed in Annex I;       (c) the manufacturer's own mark, the trade mark of the product and the trade description of the product;       (d) the specific directions for the use, storage and handling of the fertilizer.         The indications referred to in (c) and (d) may not conflict with those referred to in (a) and (b) and must be clearly separated from them.  2. All the markings referred to in paragraph 1 must be clearly separated from any other information on the packages, labels and accompanying documents.   Article 5 Member States may require that in their territory the label, the markings on the package and the accompanying documents should appear in at least their national language or languages.   Article 6 In the case of packaged fertilizers, the package must be closed in such a way or by such a device that, when it is opened, the fastening, fastening seal or the package itself is irreparably damaged.  Valve sacks may be used.   Article 7 Without prejudice to the provisions of other Community Directives, Member States may not on grounds of composition, identification, labelling or packaging, prohibit, restrict or hinder the marketing of fertilizers marked "EEC fertilizer" which comply with the provisions of this Directive and the Annexes thereto.   Article 8 1. Member States shall take all the necessary measures to ensure that fertilizers marketed with the marking "EEC fertilizer" are subjected to official  control measures for the purpose of verifying that they comply with this Directive and with Annexes I and II thereto.  2. Compliance with this Directive and with Annexes I and II in respect of conformity to types of fertilizer and compliance with the declared nutrient content and the declared content expressed as forms and/or solubilities of such nutrients may be verified at official inspections only by means of sampling and analysis methods established in accordance with this Directive and taking into account the tolerances specified in Annex III.  3. Member States may take all the necessary measures to ensure that systematic advantage is not taken of the tolerances defined in Annex III.   Article 9 1. Any amendments which are necessary in order to adjust columns 4, 5 and 6 of Part A and columns 8, 9 and 10 of Part B of Annexes I and III to technical progress shall be adopted in accordance with the procedure laid down in Article 11.  2. Sampling and analysis methods shall likewise be determined in accordance with the said procedure.   Article 10 1. A committee (hereinafter called "the committee"), is hereby set up to adjust to technical progress those Directives which concern the abolition of technical barriers to trade in fertilizers. It shall consist of representatives of the Member States with a representative of the Commission as chairman.  2. The committee shall adopt its rules of procedure.   Article 11 1. Where the procedure laid down in this Article is to be followed, the matter shall be referred to the committee by the chairman, either on his own initiative or at the request of a representative of a Member State.  2. The representative of the Commission shall submit to the committee a draft of the measures to be adopted. The committee shall deliver its opinion on the draft within a period of two months. Opinions shall be adopted by a majority of 41 votes, the votes of the Member States being weighted as provided in Article 148 (2) of the Treaty. The chairman shall not vote.  3.    (a) Where the proposed measures are in accordance with the opinion of the committee, the Commission shall adopt them.       (b) Where the proposed measures are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall without delay propose to the Council the measures to be adopted. The Council shall act by a qualified majority.       (c) If, within three months of the proposal being submitted to it, the Council has not acted, the proposed measures shall be adopted by the Commission.         Article 12 1. Member States shall bring into force the provisions necessary to comply with this Directive within 24 months of its notification and shall forthwith inform the Commission thereof.  2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive.   Article 13 This Directive is addressed to the Member States.     Done at Brussels, 18 December 1975.  For the Council  The President  M. TOROS  >PIC FILE= "T0009028">    >PIC FILE= "T0009029">    >PIC FILE= "T0009030">    >PIC FILE= "T0009031">    >PIC FILE= "T0009032">    >PIC FILE= "T0009033">    >PIC FILE= "T0009034">    >PIC FILE= "T0009035">    >PIC FILE= "T0009036">    >PIC FILE= "T0009037">    >PIC FILE= "T0009038">    >PIC FILE= "T0009039">    >PIC FILE= "T0009040">    >PIC FILE= "T0009041">    >PIC FILE= "T0009042">    >PIC FILE= "T0009043">    >PIC FILE= "T0009044">    >PIC FILE= "T0009045">      ANNEX II PROVISIONS CONCERNING IDENTIFICATION AND LABELLING    1. Compulsory identification markings      (a) The words "EEC FERTILIZER" in capital letters.           (b) The designation of the type of fertilizer, in accordance with Annex I, and the numbers indicating the nutrient content which, for compound fertilizers, should be in the order laid down by the said designation.           (c) The declared content in respect of each nutrient ; and the declared content expressed as forms and/or solubilities where those are specified in Annex I.  The nutrient content for straight and compound fertilizers must be given as a percentage by weight, as whole numbers or, where necessary, to one decimal place and for compound fertilizers in the following order : N, P2O5 and/or P, K2O and/or K.  The forms and solubilities of the nutrients must also be expressed as a percentage by weight of fertilizer, except where Annex I explicitly provides that this content shall be otherwise expressed.  Nutrients must be indicated both in words and by the appropriate chemical symbols (e.g. nitrogen (N), phosphorus (P), phosphorus pentoxide (P2O5), potassium (K), potassium oxide (K2O), magnesium (Mg), magnesium oxide (MgO)).           (d) Guaranteed net or gross weight.  If the gross weight is given, the tare weight must be indicated beside it.           (e) The name or trade name or trademark and the address of the person responsible for marketing the fertilizer, established within the Community.                  2. Labelling requirements     (a) The labels or markings printed on the package and giving the particulars mentioned under 1 must be placed in a conspicuous position. Attached labels must be held in place by whatever system is used for closing the package. If this system consists of a lead or other type of seal, the seal must bear the name or mark of the person responsible referred to under 1 (e).       (b) The markings referred to in paragraph 1 must be and must remain indelible and clearly legible.       (c) In the cases referred to in Article 3, a copy of the documents containing the identification markings must accompany the goods and be accessible for inspection purposes.                ANNEX III TOLERANCES    (a) The tolerances given in this Annex are the permitted deviation of the measured value of a nutrient from its declared value.       (b) They are intended to accommodate variations in manufacturing, sampling and analysis.       (c) No tolerances are allowed in respect of the minimum and maximum contents specified in Annex I.       (d) Where no maximum is given there are no restrictions on an excess of nutrient above the declared amount.       (e) The tolerance allowed in respect of the declared nutrient contents in the various types of fertilizer are as follows: >PIC FILE= "T0009046">    >PIC FILE= "T0009047">        (f) The tolerance allowed in respect of the declared content for the various forms of nitrogen or the declared solubilities of phosphorus pentoxide is one-tenth of the overall content of the nutrient concerned with a maximum of 2 % by weight, provided that the overall content of that nutrient remains within the limits specified in Annex I and the tolerances specified in paragraph (e) above.


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31997L0055

Directive 97/55/EC of European Parliament and of the Council of 6 October 1997 amending Directive 84/450/EEC concerning misleading advertising so as to include comparative advertising

Official Journal L 290 , 23/10/1997 P. 0018 - 0023

DIRECTIVE 97/55/EC OF EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 October 1997 amending Directive 84/450/EEC concerning misleading advertising so as to include comparative advertisingTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof,Having regard to the proposal from the Commission (1),Having regard to the opinion of the Economic and Social Committee (2),Acting in accordance with the procedure laid down in Article 189b of the Treaty (3), in the light of the joint text approved by the Conciliation Committee on 25 June 1997,(1) Whereas one of the Community's main aims is to complete the internal market; whereas measures must be adopted to ensure the smooth running of the said market; whereas the internal market comprises an area which has no internal frontiers and in which goods, persons, services and capital can move freely;(2) Whereas the completion of the internal market will mean an ever wider range of choice; whereas, given that consumers can and must make the best possible use of the internal market, and that advertising is a very important means of creating genuine outlets for all goods and services throughout the Community, the basic provisions governing the form and content of comparative advertising should be uniform and the conditions of the use of comparative advertising in the Member States should be harmonized; whereas if these conditions are met, this will help demonstrate objectively the merits of the various comparable products; whereas comparative advertising can also stimulate competition between suppliers of goods and services to the consumer's advantage;(3) Whereas the laws, regulations and administrative provisions of the individual Member States concerning comparative advertising differ widely; whereas advertising reaches beyond the frontiers and is received on the territory of other Member States; whereas the acceptance or non-acceptance of comparative advertising according to the various national laws may constitute an obstacle to the free movement of goods and services and create distortions of competition; whereas, in particular, firms may be exposed to forms of advertising developed by competitors to which they cannot reply in equal measure; whereas the freedom to provide services relating to comparative advertising should be assured; whereas the Community is called on to remedy the situation;(4) Whereas the sixth recital of Council Directive 84/450/EEC of 10 September 1984 relating to the approximation of laws, regulations and administrative provisions of the Member States concerning misleading advertising (4) states that, after the harmonization of national provisions against misleading advertising, 'at a second stage . . ., as far as necessary, comparative advertising should be dealt with, on the basis of appropriate Commission proposals`;(5) Whereas point 3 (d) of the Annex to the Council Resolution of 14 April 1975 on a preliminary programme of the European Economic Community for a consumer protection and information policy (5) includes the right to information among the basic rights of consumers; whereas this right is confirmed by the Council Resolution of 19 May 1981 on a second programme of the European Economic Community for a consumer protection and information policy (6), point 40 of the Annex, which deals specifically with consumer information; whereas comparative advertising, when it compares material, relevant, verifiable and representative features and is not misleading, may be a legitimate means of informing consumers of their advantage;(6) Whereas it is desirable to provide a broad concept of comparative advertising to cover all modes of comparative advertising;(7) Whereas conditions of permitted comparative advertising, as far as the comparison is concerned, should be established in order to determine which practices relating to comparative advertising may distort competition, be detrimental to competitors and have an adverse effect on consumer choice; whereas such conditions of permitted advertising should include criteria of objective comparison of the features of goods and services;(8) Whereas the comparison of the price only of goods and services should be possible if this comparison respects certain conditions, in particular that it shall not be misleading;(9) Whereas, in order to prevent comparative advertising being used in an anti-competitive and unfair manner, only comparisons between competing goods and services meeting the same needs or intended for the same purpose should be permitted;(10) Whereas the international conventions on copyright as well as the national provisions on contractual and non-contractual liability shall apply when the results of comparative tests carried out by third parties are referred to or reproduced in comparative advertising;(11) Whereas the conditions of comparative advertising should be cumulative and respected in their entirety; whereas, in accordance with the Treaty, the choice of forms and methods for the implementation of these conditions shall be left to the Member States, insofar as those forms and methods are not already determined by this Directive;(12) Whereas these conditions should include, in particular, consideration of the provisions resulting from Council Regulation (EEC) No 2081/92 of 14 July 1992 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (7), and in particular Article 13 thereof, and of the other Community provisions adopted in the agricultural sphere;(13) Whereas Article 5 of First Council Directive 89/104/EEC of 21 December 1988 to approximate the laws of the Member States relating to trade marks (8) confers exclusive rights on the proprietor of a registered trade mark, including the right to prevent all third parties from using, in the course of trade, any sign which is identical with, or similar to, the trade mark in relation to identical goods or services or even, where appropriate, other goods;(14) Whereas it may, however, be indispensable, in order to make comparative advertising effective, to identify the goods or services of a competitor, making reference to a trade mark or trade name of which the latter is the proprietor;(15) Whereas such use of another's trade mark, trade name or other distinguishing marks does not breach this exclusive right in cases where it complies with the conditions laid down by this Directive, the intended target being solely to distinguish between them and thus to highlight differences objectively;(16) Whereas provisions should be made for the legal and/or administrative means of redress mentioned in Articles 4 and 5 of Directive 84/450/EEC to be available to control comparative advertising which fails to meet the conditions laid down by this Directive; whereas according to the 16th recital of the Directive, voluntary control by self-regulatory bodies to eliminate misleading advertising may avoid recourse to administrative or juridical action and ought therefore to be encouraged; whereas Article 6 applies to unpermitted comparative advertising in the same way;(17) Whereas national self-regulatory bodies may coordinate their work through associations or organizations established at Community level and inter alia deal with cross-border complaints;(18) Whereas Article 7 of Directive 84/450/EEC allowing Member States to retain or adopt provisions with a view to ensuring more extensive protection for consumers, persons carrying on a trade, business, craft or profession, and the general public, should not apply to comparative advertising, given that the objective of amending the said Directive is to establish conditions under which comparative advertising is permitted;(19) Whereas a comparison which presents goods or services as an imitation or a replica of goods or services bearing a protected trade mark or trade name shall not be considered to fulfil the conditions to be met by permitted comparative advertising;(20) Whereas this Directive in no way affects Community provisions on advertising for specific products and/or services or restrictions or prohibitions on advertising in particular media;(21) Whereas, if a Member State, in compliance with the provisions of the Treaty, prohibits advertising regarding certain goods or services, this ban may, whether it is imposed directly or by a body or organization responsible under the law of that Member State for regulating the exercise of a commercial, industrial, craft or professional activity, be extended to comparative advertising;(22) Whereas Member States shall not be obliged to permit comparative advertising for goods or services on which they, in compliance with the provisions of the Treaty, maintain or introduce bans, including bans as regards marketing methods or advertising which targets vulnerable consumer groups; whereas Member States may, in compliance with the provisions of the Treaty, maintain or introduce bans or limitations on the use of comparisons in the advertising of professional services, whether imposed directly or by a body or organization responsible under the law of the Member States for regulating the exercise of a professional activity;(23) Whereas regulating comparative advertising is, under the conditions set out in this Directive, necessary for the smooth running of the internal market and whereas action at Community level is therefore required; whereas the adoption of a Directive is the appropriate instrument because it lays down uniform general principles while allowing the Member States to choose the form and appropriate method by which to attain these objectives; whereas it is in accordance with the principle of subsidiarity,HAVE ADOPTED THIS DIRECTIVE:Article 1 Directive 94/450/EEC is hereby amended as follows:(1) The title shall be replaced by the following:'Council Directive of 10 September 1984 concerning misleading and comparative advertising`;(2) Article 1 shall be replaced by the following:'Article 1The purpose of this Directive is to protect consumers, persons carrying on a trade or business or practising a craft or profession and the interests of the public in general against misleading advertising and the unfair consequences thereof and to lay down the conditions under which comparative advertising is permitted.`;(3) The following point shall be inserted in Article 2:'2a "comparative advertising" means any advertising which explicitly or by implication identifies a competitor or goods or services offered by a competitor;`(4) The following Article shall be added:'Article 3a1. Comparative advertising shall, as far as the comparison is concerned, be permitted when the following conditions are met:(a) it is not misleading according to Articles 2 (2), 3 and 7 (1);(b) it compares goods or services meeting the same needs or intended for the same purpose;(c) it objectively compares one or more material, relevant, verifiable and representative features of those goods and services, which may include price;(d) it does not create confusion in the market place between the advertiser and a competitor or between the advertiser's trade marks, trade names, other distinguishing marks, goods or services and those of a competitor;(e) it does not discredit or denigrate the trade marks, trade names, other distinguishing marks, goods, services, activities, or circumstances of a competitor;(f) for products with designation of origin, it relates in each case to products with the same designation;(g) it does not take unfair advantage of the reputation of a trade mark, trade name or other distinguishing marks of a competitor or of the designation of origin of competing products;(h) it does not present goods or services as imitations or replicas of goods or services bearing a protected trade mark or trade name.2. Any comparison referring to a special offer shall indicate in a clear and unequivocal way the date on which the offer ends or, where appropriate, that the special offer is subject to the availability of the goods and services, and, where the special offer has not yet begun, the date of the start of the period during which the special price or other specific conditions shall apply.`;(5) The first and second subparagraphs of Article 4 (1) shall be replaced by the following:'1. Member States shall ensure that adequate and effective means exist to combat misleading advertising and for the compliance with the provisions on comparative advertising in the interests of consumers as well as competitors and the general public.Such means shall include legal provisions under which persons or organizations regarded under national law as having a legitimate interest in prohibiting misleading advertising or regulating comparative advertising may:(a) take legal action against such advertising; and/or(b) bring such advertising before an administrative authority competent either to decide on complaints or to initiate appropriate legal proceedings.`;(6) Article 4 (2) is hereby amended as follows:(a) the indents in the first subparagraph shall be replaced by the following:'- to order the cessation of, or to institute appropriate legal proceedings for an order for the cessation of, misleading advertising or unpermitted comparative advertising, or- if the misleading advertising or unpermitted comparative advertising has not yet been published but publication is imminent, to order the prohibition of, or to institute appropriate legal proceedings for an order for the prohibition of, such publication,`;(b) the introductory wording to the third subparagraph shall be replaced by the following:'Furthermore, Member States may confer upon the courts or administrative authorities powers enabling them, with a view to eliminating the continuing effects of misleading advertising or unpermitted comparative advertising, the cessation of which has been ordered by a final decision:`;(7) Article 5 shall be replaced by the following:'Article 5This Directive does not exclude the voluntary control, which Member States may encourage, of misleading or comparative advertising by self-regulatory bodies and recourse before such bodies are in addition to the court of administrative proceedings referred to in that Article.`;(8) Article 6 (a) shall be replaced by the following:'(a) to require the advertiser to furnish evidence as to the accuracy of factual claims in advertising if, taking into account the legitimate interest of the advertiser and any other party to the proceedings, such a requirement appears appropriate on the basis of the circumstances of the particular case and in the case of comparative advertising to require the advertiser to furnish such evidence in a short period of time; and`;(9) Article 7 shall be replaced by the following:'Article 71. This Directive shall not preclude Member States from retaining or adopting provisions with a view to ensuring more extensive protection, with regard to misleading advertising, for consumers, persons carrying on a trade, business, craft or profession, and the general public.2. Paragraph 1 shall not apply to comparative advertising as far as the comparison is concerned.3. The provisions of this Directive shall apply without prejudice to Community provisions on advertising for specific products and/or services or to restrictions or prohibitions on advertising in particular media.4. The provisions of this Directive concerning comparative advertising shall not oblige Member States which, in compliance with the provisions of the Treaty, maintain or introduce advertising bans regarding certain goods or services, whether imposed directly or by a body or organization responsible, under the law of the Member States, for regulating the exercise of a commercial, industrial, craft or professional activity, to permit comparative advertising regarding those goods or services. Where these bans are limited to particular media, the Directive shall apply to the media not covered by these bans.5. Nothing in this Directive shall prevent Member States from, in compliance with the provisions of the Treaty, maintaining or introducing bans or limitations on the use of comparisons in the advertising of professional services, whether imposed directly or by a body or organization responsible, under the law of the Member States, for regulating the exercise of a professional activity.`Article 2 Complaints systems The Commission shall study the feasibility of establishing effective means to deal with cross-border complaints in respect of comparative advertising. Within two years after the entry into force of this Directive the Commission shall submit a report to the European Parliament and the Council on the results of the studies, accompanied if appropriate by proposals.Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive at the latest 30 months after its publication in the Official Journal of the European Communities. They shall forthwith inform the Commission thereof.2. 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 reference shall be laid down by Member States.3. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field governed by this Directive.Article 4 This Directive is addressed to the Member States.Done at Brussels, 6 October 1997.For the European ParliamentThe PresidentJ. M. GIL-ROBLESFor the CouncilThe PresidentJ. POOS(1) OJ C 180, 11. 7. 1991, p. 14, and OJ C 136, 19. 5. 1994, p. 4.(2) OJ C 49, 24. 2. 1992, p. 35.(3) Opinion of the European Parliament of 18 November 1992 (OJ C 337, 21. 12. 1992, p. 142), Common Position of the Council of 19 March 1996 (OJ C 219, 27. 7. 1996, p. 14) and Decision of the European Parliament of 23 October 1996 (OJ C 347, 16. 11. 1996, p. 69). Decision of the European Parliament of 16 September 1997 and Decision of the Council of 15 September 1997.(4) OJ L 250, 19. 9. 1984, p. 17.(5) OJ C 92, 25. 4. 1975, p. 1.(6) OJ C 133, 3. 6. 1981, p. 1.(7) OJ L 208, 24. 7. 1992, p. 1.(8) OJ L 40, 11. 2. 1989, p. 1. Directive as last amended by Decision 92/10/EEC (OJ L 6, 11. 1. 1992, p. 35).Commission declaration The Commission declares that it intends to submit the report referred to in Article 2 as far as possible at the same time as the report on complaints systems provided for in Article 17 of Directive 97/7/EC on the protection of consumers in respect of distance contracts.


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32001L0109

Directive 2001/109/EC of the European Parliament and of the Council of 19 December 2001 concerning the statistical surveys to be carried out by the Member States in order to determine the production potential of plantations of certain species of fruit trees

Official Journal L 013 , 16/01/2002 P. 0021 - 0024

Directive 2001/109/EC of the European Parliament and of the Councilof 19 December 2001concerning the statistical surveys to be carried out by the Member States in order to determine the production potential of plantations of certain species of fruit treesTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 285 thereof,Having regard to the proposal from the Commission(1),Acting in accordance with the procedure laid down in Article 251 of the Treaty(2),Whereas:(1) The Commission, in order to perform the task conferred upon it by the Treaty and by Community provisions governing the common organisation of the market in the fruit and vegetable sector, needs to be kept accurately informed on the production potential of plantations of certain species of fruit trees within the Community and to have available medium-term estimates of production and supply on the markets. This information is currently provided for within the framework of Council Directive 76/625/EEC of 20 July 1976 concerning the statistical surveys to be carried out by the Member States in order to determine the production potential of plantations of certain species of fruit trees(3). Now that new amendments are being made, it is appropriate on the grounds of clarity to repeal the said Directive and replace it by this Directive.(2) All the Member States should carry out surveys concurrently on plantations of fruit trees of the same species in accordance with the same criteria and with comparable accuracy. New plantations attain their full yield only after a certain number of years. These surveys should therefore be repeated every five years in order to obtain reliable statistics on production potential taking account of the fruit trees which are not yet productive.(3) Uniform surveys should be carried out in each Member State on the main varieties of each species of fruit, endeavouring at the same time to establish sub-divisions according to variety which are as complete as necessary.(4) The experience acquired in previous surveys of fruit tree plantations has shown that it is necessary to introduce a certain flexibility into survey methods used by the Member States whilst maintaining the comparability of data between Member States.(5) Since the objectives of the proposed action, namely to obtain complete and reliable statistics on the production potential of plantations of certain species of fruit trees in the Community and on medium-term estimates of Community production and supply, cannot be sufficiently achieved by the Member States individually and can therefore, by reason of the effects of the action, 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 to achieve those objectives.(6) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(4),HAVE ADOPTED THIS DIRECTIVE:Article 11. The Member States shall carry out during 2002, and every five years thereafter, surveys on plantations of certain species of fruit trees existing on their territory.2. The following species shall be surveyed:(a) dessert apples(b) dessert pears(c) peaches(d) apricots(e) oranges(f) lemons(g) small-fruited citrus fruit.The species to be surveyed in the various Member States are set out in the table in the Annex.The list of said species and the said table may be amended in accordance with the procedure referred to in Article 8(2).The survey of plantations of varieties of apples and pears destined solely for uses other than dessert apples and pears shall be optional.3. The survey shall apply to all holdings with an area planted with fruit trees, provided that the fruit produced is entirely or mainly intended for the market.The survey shall cover pure and mixed crops, i.e. plantations of fruit trees of several of the species referred to in the first subparagraph of paragraph 2 or of one or more of them together with other species.4. The survey may be either exhaustive or based on random sampling, in accordance with the criteria laid down in Article 3.Article 21. The surveys referred to in Article 1 shall be organised so that the results may be presented in various combinations of the following characteristics:(A) Variety of fruit:For each species of fruit, and in order of importance, enough varieties shall be shown to enable a separate assessment to be made for each Member State, by variety, of at least 80 % of the total area planted with fruit trees of the species in question and, in any case, all varieties representing 3 % or more of the total area planted with fruit trees of the species in question.(B) Age of trees:The age of trees must be calculated from the time of their planting in the orchard. The planting season which extends from the autumn to the spring shall be considered a single period.(C) Area planted, number of trees and density of plantation:The density of plantation may be surveyed and quoted directly or may be calculated from the area planted.2. Detailed rules for applying this Article shall be adopted in accordance with the procedure referred to in Article 8(2).Article 31. In the case of random sampling, the sample shall be representative of at least 95 % of the area planted with fruit trees. Estimates shall be made for areas not covered by sampling.2. So far as the results of the surveys carried out by random sampling are concerned, Member States shall take every measure to ensure that sampling errors at the 68 % confidence level shall, at the most, be of the order of 3 % for the whole of the national area planted with fruit trees of each species.3. Member States shall take appropriate measures to limit mistakes of reporting and, if necessary, to estimate their effect on the whole of the area planted with fruit trees of each species.4. The rules for applying this Article shall be adopted in accordance with the procedure referred to in Article 8(2).Article 41. Member States shall notify the Commission of the results of these surveys as rapidly as possible, and in any case before 1 October of the year following the survey year.2. The results referred to in paragraph 1 shall be supplied for each production area. The boundaries of the production areas to be adopted for Member States shall be fixed in accordance with the procedure laid down in Article 8(2).3. Sampling errors together with any mistakes discovered in reporting as referred to in Article 3 shall be notified before 1 October of the year following the survey year.4. Member States shall send the Commission a methodological report on how the survey was carried out no later than 1 October of the year following the survey year.Article 5Member States which have annual estimates:(a) of areas of fruit trees, the clearing of which has been carried out on their territory, and(b) of the new plantations of fruit trees on their territory,shall notify the Commission of this information no later than 31 October of the year following the reference year.Article 6The Commission shall study the following in consultation and ongoing cooperation with Member States:(a) the results supplied,(b) the technical problems raised, in particular by the preparation and implementation of these surveys,(c) the significance of the findings of the surveys.Article 7The Commission shall submit to the European Parliament and to the Council, within one year of notification of the results by Member States, a report on experience acquired during the survey.Article 81. The Commission shall be assisted by the Standing Committee for Agricultural Statistics, set up by Council Decision 72/279/EEC(5).2. Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at three months.3. The committee shall adopt its rules of procedure.Article 9Directive 76/625/EEC shall be repealed with effect from 16 April 2002.Any references made to repealed Directive 76/625/EEC shall be considered as a reference to this Directive.Article 10Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 16 April 2002 at the latest. 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 reference shall be laid down by Member States.Article 11This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.Article 12This Directive is addressed to the Member States.Done at Brussels, 19 December 2001.For the European ParliamentThe PresidentN. FontaineFor the CouncilThe PresidentA. Neyts-Uyttebroeck(1) OJ C 96 E, 27.3.2001, p. 212.(2) Opinion of the European Parliament of 13 June 2001 (not yet published in the Official Journal), Council Common Position of 8 November 2001 (not yet published in the Official Journal) and Decision of the European Parliament of 11 December 2001 (not yet published in the Official Journal).(3) OJ L 218, 11.8.1976, p. 10. Directive as last amended by Directive 1999/87/EC of the European Parliament and of the Council (OJ L 16, 21.1.2000, p. 72).(4) OJ L 184, 17.7.1999, p. 23.(5) OJ L 179, 7.8.1972, p. 1.ANNEXSPECIES SURVEYED IN THE VARIOUS MEMBER STATES>TABLE>