title: Commission Directive 2008/116/EC of 15 December 2008 amending Council Directive 91/414/EEC to include aclonifen, imidacloprid and metazachlor as active substances (Text with EEA relevance)

text:
               16.12.2008

               EN

               Official Journal of the European Union

               L 337/86

      COMMISSION DIRECTIVE 2008/116/EC
   of 15 December 2008
   amending Council Directive 91/414/EEC to include aclonifen, imidacloprid and metazachlor 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 aclonifen, imidacloprid and metazachlor.

               (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 aclonifen and imidacloprid the rapporteur Member State was Germany and all relevant information was submitted on 11 September 2006 and on 13 June 2006 respectively. For metazachlor the rapporteur Member State was United Kingdom and all relevant information was submitted on 30 September 2005.

               (3)

               The assessment reports have been peer reviewed by the Member States and the EFSA and presented to the Commission on 31 July 2008 for aclonifen, on 29 May 2008 for imidacloprid and on 14 April 2008 for metazachlor 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 26 September 2008 in the format of the Commission review reports for aclonifen, imidacloprid and metazachlor.

               (4)

               It has appeared from the various examinations made that plant protection products containing aclonifen, imidacloprid and metazachlor 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, it is appropriate to require that aclonifen should be subjected to further testing for evaluation of residues in rotational crops and for the confirmation of the risk assessment for birds, mammals, aquatic organisms and non-target plants and that imidacloprid should be subjected to further testing for confirmation of the risk assessment for operators and workers and the risk to birds and mammals and such studies should be presented by the notifier. Furthermore for metazachlor it is appropriate to obtain additional information on certain specific points. Article 5(5) of Directive 91/414/EEC provides that an inclusion may be reviewed at any time if there are indications that the criteria referred to in paragraphs 1 and 2 are no longer satisfied. The notifier has submitted information which at this stage is considered to be sufficient to address the relevance of certain metabolites. However, a decision on the classification of metazachlor under Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (5) is not yet finalised. Such decision might lead to the need for further information on these metabolites. The information submitted by the notifier to address the relevance of the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 with respect to cancer is, at this stage, considered as sufficient. However, if a decision is adopted under Directive 67/548/EEC by which metazachlor is classified as ‘limited evidence of a cancerogenic effect’, further information will be needed on the relevance of those metabolites with respect to cancer. Article 6(1) of Directive 91/414/EEC provides that the inclusion of a substance in Annex I to that Directive may be subject to conditions. The inclusion of metazachlor should therefore be subject to a condition concerning the submission of further information in case that substance is classified under Directive 67/548/EEC.

               (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 aclonifen, imidacloprid and metazachlor 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 Commission Regulation (EEC) No 3600/92 (6) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I.

               (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 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
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing aclonifen, imidacloprid and metazachlor as active substances by 31 January 2010.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to aclonifen, imidacloprid and metazachlor 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 aclonifen, imidacloprid and metazachlor as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 July 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 aclonifen, imidacloprid and metazachlor 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 aclonifen, imidacloprid and metazachlor as the only active substance, where necessary, amend or withdraw the authorisation by 31 January 2014 at the latest; or

               (b)

               in the case of a product containing aclonifen, imidacloprid and metazachlor as one of several active substances, where necessary, amend or withdraw the authorisation by 31 January 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 August 2009.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 15 December 2008.

            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) 149, Conclusion regarding the peer review of the pesticide risk assessment of the active substance aclonifen (finalised 31 July 2008).
   EFSA Scientific Report (2008) 148, Conclusion regarding the peer review of the pesticide risk assessment of the active substance imidacloprid (finalised 29 May 2008).
   EFSA Scientific Report (2008) 145, Conclusion regarding the peer review of the pesticide risk assessment of the active substance metazachlor (finalised 14 April 2008).

      (5)  OJ 196, 16.8.1967, p. 1.

      (6)  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

                     ‘221

                     Aclonifen
                     CAS No 74070-46-5
                     CIPAC No 498

                     2-chloro-6-nitro-3-phenoxyaniline

                     ≥ 970 g/kg
                     The impurity phenol is of toxicological concern and a maximum level of 5 g/kg is established.

                     1 August 2009

                     31 July 2019

                     PART A
                     Only uses as herbicide may be authorised.
                     PART B
                     In assessing applications to authorise plant protection products containing aclonifen for uses other than sunflower, 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 aclonifen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 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 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 protection of the operators safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,

                                 —

                                 the residues in rotational crops and evaluate the dietary exposure of consumers,

                                 —

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

                           The Member States concerned shall request the submission of further studies on rotational crops residues and relevant information to confirm the risk assessment for birds, mammals, aquatic organisms and non-target plants.
                     They shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the entry into force of this Directive.

                     222

                     Imidacloprid
                     CAS No 138261-41-3
                     CIPAC No 582

                     (E)-1-(6-Chloro-3-pyridinylmethyl)-N-nitroimidazolidin-2-ylideneamine

                     ≥ 970 g/kg

                     1 August 2009

                     31 July 2019

                     PART A
                     Only uses as insecticide may be authorised.
                     For the protection of non-target organisms, in particular honey bees and birds, for use as seed treatment:

                                 —

                                 the seed coating shall only be performed in professional seed treatment facilities. These facilities must apply the best available techniques in order to ensure that the release of dust clouds during storage, transport and application can be excluded,

                                 —

                                 adequate application equipment shall be used to ensure a high degree of incorporation in soil, minimisation of spillage and minimisation of dust clouds emission. Member States shall ensure that the label of treated seed includes the indication that the seeds were treated with imidacloprid and sets out the risk mitigation measures provided for in the authorisation.

                           PART B
                     In assessing applications to authorise plant protection products containing imidacloprid for uses other than tomatoes in glasshouses, 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 imidacloprid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

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

                                 —

                                 the impact on aquatic organisms, non-target arthropods, earthworms, other soil macroorganisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures,

                                 —

                                 the protection of honey bees, in particular for spray applications and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

                           The Member States concerned shall request the submission of:

                                 —

                                 information to further address the risk assessment for operators and workers,

                                 —

                                 information to further address the risk to birds and mammals.

                           They shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the entry into force of this Directive.

                     223

                     Metazachlor
                     CAS No 67129-08-2
                     CIPAC No 411

                     2-chloro-N-(pyrazol-1-ylmethyl)acet-2′,6′-xylidide

                     ≥ 940 g/kg
                     The manufacturing impurity toluene is considered to be of toxicological concern and a maximum level of 0,01 % is established.

                     1 August 2009

                     31 July 2019

                     PART A
                     Only uses as herbicide may be authorised; application max. of 1,0 kg/ha only every third year on the same field.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on metazachlor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 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 aquatic organisms,

                                 —

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

                           Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential groundwater contamination from the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 in vulnerable zones, where appropriate.
                     If metazachlor is classified under Directive 67/548/EEC as “limited evidence of a cancerogenic effect”, the Member States concerned shall request the submission of further information on the relevance of the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 with respect to cancer.
                     They shall ensure that the notifiers provide that information to the Commission within six months from the notification of such a classification decision.’

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


Avis juridique important

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31999L0001

Commission Directive 1999/1/EC of 21 January 1999 including an active substance (kresoxim-methyl) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance)

Official Journal L 021 , 28/01/1999 P. 0021 - 0023

COMMISSION DIRECTIVE 1999/1/EC of 21 January 1999 including an active substance (kresoxim-methyl) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market (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), as last amended by Commission Directive 97/73/EC (2), hereinafter referred to as 'the Directive`, and in particular Article 6(3) thereof,Whereas in accordance with Article 6(2) of Directive 91/414/EEC Belgium received on 28 March 1995 an application from BASF Aktiengesellschaft, hereinafter referred to as 'the applicant`, for the inclusion of the active substance kresoxim-methyl in Annex I to the Directive;Whereas in accordance with the provisions of Article 6(3) of the Directive the Commission confirmed in its Decision 96/266/EC (3), that the dossier submitted for kresoxim-methyl could be considered as satisfying, in principle, the data and information requirements of Annex II, and for plant protection products containing this active substance, of Annex III to the Directive;Whereas, in accordance with Article 5(1) of the Directive, an active substance should be included for a period not exceeding 10 years in Annex I when it may be expected that there will not be any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment;Whereas for kresoxim-methyl, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of the Directive, for the uses proposed by the applicant; whereas Belgium acting as rapporteur Member State has submitted to the Commission on 15 January 1997 the assessment report concerned;Whereas the submitted report has been reviewed by the Member States and the Commission within the Standing Committee on Plant Health; whereas this review has been finalised on 16 October 1998 in the format of the Commission review report for kresoxim-methyl; whereas it may be necessary to update this report to take account of technical and scientific developments; whereas in such case the conditions for the inclusion of kresoxim-methyl in Annex I to Directive 91/414/EEC will also need to be amended pursuant to Article 6(1) of that Directive;Whereas the dossier and the information from the review have also been submitted to the Scientific Committee for Plants for consultation; whereas this Committee has given its opinion on 14 July 1998;Whereas it has appeared from the assessments made that plant protection products containing the active substance concerned may be expected to satisfy in general the requirements laid down in Article 5(1)(a), (b) and (3) of the Directive, in particular with regard to the uses which were examined; whereas therefore it is necessary to include the active substance concerned in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing the active substance concerned can be granted in accordance with the provisions of the Directive;Whereas after inclusion a reasonable period is necessary to permit Member States to implement the provisions of Directive 91/414/EEC on plant protection products containing kresoxim-methyl, and in particular to review, within this period, existing provisional authorisations or to grant, by the end of this period at the latest, new authorisations in accordance with the provisions of the Directive; whereas a longer period may also be required for plant protection products containing kresoxim-methyl and other active substances included in Annex I.Whereas it is appropriate to provide that the finalised review report (except for confidential information in the meaning of Article 14 of the Directive) is kept available or made available by the Member States for consultation by any interested parties;Whereas the review report is required for the proper implementation by the Member States, of several sections of the uniform principles laid down in Annex VI to the Directive, where these principles refer to the evaluation of the Annex II data which were submitted for the purpose of the inclusion of the active substance in Annex I to the Directive;Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health delivered on the 16 October 1998,HAS ADOPTED THIS DIRECTIVE:Article 1 Kresoxim-methyl is hereby designated as an active substance in Annex I to Directive 91/414/EEC, as set out in the Annex hereto.Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive, at the latest by 31 July 1999.2. However for plant protection products containing kresoxim-methyl together with another active substance included in Annex I to Directive 91/414/EEC, the period referred to in paragraph 1 is extended to the extent that a longer implementation period is provided for by the provisions laid down in the Directive concerning the inclusion of this other active substance in Annex I to Directive 91/414/EEC.3. Member States shall keep available the review report except for confidential information in the meaning of Article 14 of the Directive for consultation by any interested parties or shall make it available to them on specific request.4. When Member States adopt the measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be laid down by the Member States.Article 3 This Directive shall enter into force on 1 February 1999.Article 4 This Directive is addressed to the Member States.Done at Brussels, 21 January 1999.For the CommissionFranz FISCHLERMember of the Commission(1) OJ L 230, 19. 8. 1991, p. 1.(2) OJ L 353, 24. 12. 1997, p. 26.(3) OJ L 91, 12. 4. 1996, p. 74.ANNEX KRESOXIM-METHYL 1. Identity:(IUPAC) methyl (E)-2-methoxyimino-2-[2-(o-tolyloxymethyl)phenyl]acetate.2. Particular conditions to be fulfilled:2.1. The active substance shall have a minimum purity of 910 g/kg.2.2. Only uses as fungicide may be authorised.2.3. Member States shall pay particular attention to the protection of groundwater under vulnerable conditions.2.4. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on kresoxim-methyl, and in particular the Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 16 October 1998 shall be taken into account.3. Expiry date of the inclusion: 31 January 2009.


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31991L0682

Council Directive 91/682/EEC of 19 December 1991 on the marketing of ornamental plant propagating material and ornamental plants

Official Journal L 376 , 31/12/1991 P. 0021 - 0028 Finnish special edition: Chapter 3 Volume 40 P. 0009  Swedish special edition: Chapter 3 Volume 40 P. 0009

COUNCIL DIRECTIVEof 19 December  1991on the marketing of ornamental plant propagating material and ornamental  plants(91/682/EEC)THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic 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 the production of ornamental plants occupies an important place in the agriculture of the  Community; Whereas satisfactory results in the cultivation of ornamental plants depend to a large extent on  the quality and health of the material used for their propagation and of the plants themselves;  whereas certain Member States have in consequence introduced rules intended to guarantee the  quality and health of the propagating material of ornamental plants and ornamental plants placed on  the market; Whereas the different treatment accorded to propagating material and ornamental plants in different  Member States is likely to create barriers to trade and thus hinder the free movement of these  goods within the Community; whereas, with a view to achieving the internal market, these barriers  should be removed, by adopting Community provisions to replace those laid down by the Member  States; Whereas the establishment of harmonized conditions at Community level will ensure that purchasers  throughout the Community receive propagating material and ornamental plants which are healthy and  of good quality; Whereas, so far as they relate to plant health, such harmonized conditions must be consistent with  Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction in  to the Member States of organisms harmful to plants or plant products (4), as last amended by  Directive 91/683/EEC (5); Whereas it is appropriate initially to establish Community rules for those genera and species of  ornamental plant which are of major economic importance in the Community, with a Community  procedure for adding further genera and species later; Whereas, without prejudice to the plant health provisions of Directive 77/93/EEC, it is not  appropriate to apply the Community rules on the marketing of propagating material and ornamental  plants when it is shown that such material and plants are intended for export to third countries,  as the rules applicable there may be different from those contained in this Directive; Whereas the determination of plant health and quality standards for each genus and species of  ornamental plant requires lengthy and detailed technical and scientific consideration; whereas a  procedure should accordingly be established for the determination of these standards; Whereas in the first instance it is the responsibility of the suppliers of propagating material  and/or ornamental plants to ensure that their products fufil the conditions laid down in this  Directive; Whereas the competent authorities of the Member States must, when carrying out controls and  inspections, ensure that suppliers fulfil those conditions; Whereas Community control measures should be introduced to ensure uniform application in all the  Member States of the standards laid down in this Directive; Whereas it is in the interests of the purchasers of propagating materials and ornamental plants  that the names of varieties or of groups of plants be known and that their identity be  safeguarded; Whereas the characteristics specific to the industry operating in the ornamental plant sector are a  complicating factor; whereas, accordingly, the objective stated above can best be achieved either  through common knowledge of the variety or, in the case of varieties or groups of plants, through  the availability of a description drawn up and kept by the supplier; Whereas, in order to ensure the identity and orderly marketing of propagating material and  ornamental plants, Community rules must be laid down concerning the separation of lots and marking;  whereas the labels should give the particulars needed both for official control and for the  information of the grower; Whereas rules should be established permitting, in the case of temporary supply difficulties, the  marketing of propagating material and ornamental plants subject to requirements less stringent than  those contained in this Directive; Whereas, as a first step towards harmonized conditions, Member States should be prohibited in the  case of the genera and species referred to in the Annex, for which fact sheets will be drawn up,  from imposing new conditions or marketing restrictions on propagating material or ornamental  plants, other than those provided for in this Directive; Whereas provision should be made for authorizing the marketing, within the Community, of  propagating material and ornamental plants produced in third countries, provided always that they  afford the same assurance as propagating material and ornamental plants produced in the Community  and complying with Community rules; Whereas, in order to harmonize technical methods of examination used in the Member States and to  compare propagating material and ornamental plants produced in the Community with those produced in  third countries, comparative trials should be carried out to check compliance of propagating  material and ornamental plants with the requirements of this Directive; Whereas, in order to facilitate the effective operation of this Directive, the Commission should be  entrusted with the task of adopting measures for its implementation and for the amendment of its  Annex; whereas such measures should be adopted by a procedure involving close cooperation between  the Commission and the Member States within a Standing Committee on Propagating Material and  Ornamental Plants, HAS ADOPTED THIS DIRECTIVE: Article 11.  This Directive applies to the marketing of  ornamental-plant-propagating material and ornamental plants within the Community. 2.  Articles 2 to 20 and 24 shall apply to the genera and species listed in the Annex. Rootstocks of other genera or species shall also be subject to the abovementioned Articles if  material of one of the said genera or species is grafted on to them. 3.  Amendments to the list of genera and species in the Annex shall be adopted in accordance with  the procedure laid down in Article 22. Article 2This Directive shall not apply to propagating material or ornamental plants shown to be  intended for export to third countries, if properly identified as such and kept sufficiently  isolated, without prejudice to the health rules laid down by Directive 77/93/EEC. Implementing measures for the first subparagraph, with particular reference to identification and  isolation, shall be adopted in accordance with the procedure laid down in Article 21. Article 3For the purposes of this Directive, the following definitions shall apply: (a)  Propagating material: seeds, parts of plants and all plant material intended for the  propagation and production of ornamental plants and other plants for ornamental purposes; (b)Ornamental plants: plants intended, after marketing, to be planted or replanted; (c)Supplier: any natural or legal person carrying out professionally at least one of the following  activities with regard to propagating material or ornamental plants: reproducing, producing,  preserving and/or treating and placing on the market; (d)Placing on the market: the holding available or in stock, displaying or offering for sale,  selling and/or delivering to another person, in whatever form, of propagating material or  ornamental plants; (e)Responsible official body: 1.  the sole and central authority, established or designated by the Member State under the  supervision of the national government and responsible for questions concerning quality; 2. any State authority established: - either at national level- or at regional level, under the supervision of national authorities,  within the limits set by the constitution of the Member State concerned. The bodies referred to in 1 and 2 may, in accordance with their national legislation, delegate the  tasks provided for in this Directive to be accomplished under their authority and supervision to  any legal person, whether governed by public or by private law, which, under its officially  approved constitution, is charged exclusively with specific public functions, provided that such  person, and its members, has no personal interest in the outcome of the measures it takes. The Member States shall ensure that there is close cooperation between the bodies referred to in 2  and those referred to in 1. Moreover, in accordance with the procedure laid down in Article 21, other legal persons established  on behalf of the body referred to in 1 and acting under the authority and supervision of such body  may be approved, provided that such person has no personal interest in the outcome of the measures  it takes. Member States shall notify the Commission of their responsible official bodies. The Commission  shall forward that information to the other Member States; (f)Official measures: measures taken by the responsible official body; (g)Official inspection: inspection carried out by the responsible official body; (h)Official statement: statement issued by, or under the responsibility of, the responsible  official body; (i)Lot: a number of units of a single commodity, identifiable by its homogeneity of composition  and origin; (j)Laboratory: a public - or private - law entity carrying out analysis and proper diagnosis,  enabling the producer to monitor production quality. Article 4In accordance with the procedure laid down in Article 22, a schedule shall be  established for each genus or species referred to in the Annex, with a reference to the plant  health conditions laid down in Directive 77/93/EEC applying to the genus or species concerned, and  laying down: 1.  the conditions concerning the quality with which propagating material and ornamental plants  must comply, in particular those related to the propagation system applied, the purity of the  growing crop and, where appropriate, varietal characteristics; 2. the conditions with which rootstocks of other genera and species must comply if material of the  genus or species concerned is grafted onto them. Article 51.  Member States shall ensure that suppliers take all the necessary measures to  guarantee compliance with the standards set by this Directive at all stages of the production and  marketing of ornamental-plant-propagating material and ornamental plants. 2.  To that end, the said suppliers shall either carry out themselves, or have carried out by an  accredited supplier or the responsible official body, checks based on the following principles: - identification of critical points in their production process on the basis of the production  methods used, - establishment and implementation of methods for monitoring and checking the critical points  referred to in the first indent, - taking samples for analysis in a laboratory accredited by the responsible official body for the  purpose of checking compliance with the standards established by this Directive, - keeping a written record, or a record registered in an indelible fashion, of the data referred to  in the first, second and third indents, as well as records on production and marketing of  propagating material and ornamental plants, to be held at the disposal of the responsible official  body. These documents and records shall be kept for a period of at least one year. However, suppliers whose activity in this connection is confined merely to the distribution of  propagating material and ornamental plants produced and packaged on premises other than their own  shall be required only to keep a written record or a record registered in an indelible fashion of  the buying and selling and/or delivery of propagating material and ornamental plants. This paragraph shall not apply to suppliers whose activity in this connection is confined to the  supply of small quantities of propagating material and ornamental plants to non-professional final  consumers. 3.  If the results of their own checks or any information at the disposal of the suppliers referred  to in paragraph 1 reveal the presence of one or more of the harmful organisms listed in the  relevant schedules established pursuant to Article 4, the suppliers shall immediately report this  to the responsible official body and shall carry out the measures indicated by that body. The  supplier shall keep records of all occurrences of harmful organisms on his premises and of all  measures taken in relation to such occurrences. 4.  Rules for the application of the second subparagraph of paragraph 2 shall be established in  accordance with the procedure laid down in Article 21. Article 61.  The responsible official body shall accredit suppliers once it has verified that  their production methods and establishments meet the requirements of this Directive with regard to  the nature of the activities they carry out. The accreditation must be renewed if a supplier  decides to carry out activities other than those for which he has received accreditation. 2.  The responsible official body shall accredit laboratories once it has verified that these  laboratories, their methods and their establishments meet the requirements of this Directive to be  specified according to the procedure laid down in Article 21, with regard to the testing activities  they carry out. The accreditation must be renewed if a laboratory decides to carry out activities  other than those for which it has received accreditation. 3.  The responsible official body shall take the necessary measures if the requirements referred to  in paragraphs 1 and 2 cease to be met. To this end, it shall take particular account of the  conclusions of any check carried out in accordance with Article 7. 4.  The supervision and monitoring of suppliers, establishments and laboratories shall be carried  out regularly by or under the responsibility of the responsible official body, which shall at all  times have free access to all parts of establishments, in order to ensure compliance with the  requirements of this Directive. Implementing measures concerning supervision and monitoring may be  adopted, in accordance with the procedure laid down in Article 21. If such supervision and monitoring reveal that the requirements of this Directive are not being  met, the responsible official body shall take appropriate action. Article 71.  Experts from the Commission may, in cooperation with the responsible official  bodies of the Member States, make on-the-spot checks in so far as this is necessary to ensure the  uniform application of this Directive. They may in particular verify whether suppliers are in  effect complying with the requirements of this Directive. A Member State in whose territory a check  is being carried out shall give all necessary assistance to the experts in carrying out their  duties. The Commission shall inform the Member States of the results of the investigations. 2.  Detailed rules for the application of paragraph 1 shall be adopted in accordance with the  procedure laid down in Article 21. Article 81.  Propagating material or ornamental plants shall not be placed on the market except  by accredited suppliers and unless they meet the requirements for propagating material and  ornamental plants laid down in the schedule referred to in Article 4. 2.  Without prejudice of Directive 77/93/EEC, paragraph 1 shall not apply to propagating material  or ornamental plants intended for: (a)  trials or scientific purposes; (b)selection work. Article 91.  Propagating material and ornamental plants shall be marketed with a reference  either to the variety or to the group of plants to which they belong. 2.  The varieties to which reference is made pursuant to paragraph 1 shall be: - either commonly known, and protected in accordance with provisions on the protection of new  varieties of plants, officially registered on a voluntary or other basis, - or entered on lists kept by suppliers, with their detailed descriptions and relevant  denominations. These lists must be accessible, upon request, to the responsible official body of  the Member State concerned. Each variety shall be described and, as far as possible, bear the same denomination in all the  Member States, in accordance with accepted international guidelines. 3.  Where reference is made to a group of plants, the supplier should describe and quote the  denomination of the group of plants in such a way as to avoid confusion with any of the varieties  referred to in paragraph 2. 4.  Except where the varietal aspect is explicitly mentioned in the schedules referred to in  Article 4, paragraphs 1, 2 and 3 shall not mean any extra responsibility for the responsible  official body. 5.  A system for the notification of varieties or other groups of plants to the responsible  official bodies of the Member States may be set up in accordance with the procedure laid down in  Article 21. Additional implementing provisions for the second indent of paragraph 2 may be adopted  in accordance with the same procedure. Article 101.  While growing and during lifting or removal from the parent material, propagating  material or ornamental plants shall be kept in separate lots. 2.  If propagating material or ornamental plants of different origins are put together or mixed  during packaging, storage, transport or at delivery, the supplier shall keep records including the  following data: composition of the lot and origin of the individual components. 3.  Member States shall ensure compliance with the requirements referred to in paragraphs 1 and 2  by carrying out official inspections. Article 11Without prejudice to Article 10 (2), propagating material and ornamental plants shall  be marketed only in sufficiently homogeneous lots. Propagating material and ornamental plants shall in all cases satisfy the requirements of this  Directive and shall be accompanied by a document made out by the supplier in accordance with the  conditions laid down in the schedule established pursuant to Article 4. If an official statement  appears on this document, it shall be clearly separated from all other contents of the document. If appropriate, requirements on propagating material and/or ornamental plants for labelling and/or  sealing and packaging shall be included in the schedule established pursuant to Article 4. In the case of retail supply of propagating material or ornamental plants to a non-professional  final consumer, requirements on labelling may be confined to appropriate product information. Article 12Member States may exempt- from the application of Article 11, small producers all of  whose production and sales of propagating material and ornamental plants is intended for final use  by persons on the local market who are not professionally involved in plant production ('local  circulation`), - from the official control provided for in Article 18, the local circulation of propagating  materials and ornamental plants produced by such exempt persons. In accordance with the procedure laid down in Article 21, implementing measures relating to other  requirements concerning the exemptions referred to in the first and second indents above, in  particular as regards the concepts of 'small producers` and 'local market`, and to the relevant  procedures, shall be adopted. Article 13In the event of temporary difficulties in the supply of propagating material or  ornamental plants satisfying the requirements of this Directive, rules may be adopted, in  accordance with the procedure laid down in Article 21, concerning the marketing of propagating  material and ornamental plants meeting less stringent requirements, without prejudice to the  plant-health rules laid down in Directive 77/93/EEC. Article 14The marketing of propagating material and ornamental plants which comply with the  requirements and conditions of this Directive shall be subject to no restrictions as regards  supplier, plant health, growing medium and inspection arrangements, other than those laid down in  this Directive. Article 15As concerns the products referred to in the Annex, Member States shall refrain from  imposing more stringent conditions or marketing restrictions other than the conditions laid down in  the schedules established pursuant to Article 4 or those obtaining on the date of adoption of this  Directive as the case may be. Article 161.  In accordance with the procedure laid down in Article 21, it shall be decided  whether propagating material and ornamental plants produced in a third country and affording the  same guarantees as regards obligations on the supplier, identity, characteristics, plant health,  growing medium, packaging, inspection arrangements, marking and sealing, are equivalent in all  these respects to propagating material and ornamental plants produced in the Community and  complying with the requirements and conditions of this Directive. 2.  Pending the decision referred to in paragraph 1, Member States may, until 1 January 1993, apply  to the import of propagating material and ornamental plants from third countries conditions  equivalent to those applicable to the production and marketing of products obtained in the  Community. In accordance with the procedure laid down in Article 21, the date referred to in the first  subparagraph may, for the various third countries, be put back pending the decision referred to in  paragraph 1. Propagating material and ornamental plants imported by a Member State in accordance with a decision  taken by that Member State pursuant to the first subparagraph shall be subject to no marketing  restrictions as regards the matters referred to in paragraph 1 in other Member States. Article 17Member States shall ensure that propagating material and ornamental plants are  officially inspected during production and marketing, at least by random checks, to verify  compliance with the requirements and conditions of this Directive. Article 18Detailed implementing procedures for the official inspection referred to in Articles  5, 10 and 17, including sampling methods, may be established in accordance with the procedure laid  down in Article 21. Article 191.  If, during the supervision and monitoring referred to in Article 6 (4), the  official inspection referred to in Article 17, or the trials referred to in Article 20, it is found  that propagating material or ornamental plants do not meet the requirements of this Directive, the  responsible official body of the Member State shall take appropriate action to ensure that they do  comply with the provisions of this Directive or, if that is not possible, to ban the marketing of  that propagating material or those ornamental plants in the Community. 2.  If it is found that propagating material or ornamental plants marketed by a particular supplier  do not comply with the requirements and conditions of this Directive, the Member State concerned  shall ensure that appropriate measures are taken against that supplier. If the supplier is  forbidden to market propagating material and ornamental plants, the Member State shall notify the  Commission and the competent national bodies in the Member States. 3.  Any measures taken under paragraph 2 shall be withdrawn as soon as it has been established with  adequate certainty that the propagating material or ornamental plants intended for marketing by the  supplier will, in future, comply with the requirements and conditions of this Directive. Article 201.  Trials, or where appropriate tests, shall be carried out in the Member States on  samples to check that propagating material or ornamental plants comply with the requirements and  conditions of this Directive, including those relating to plant health. The Commission may organize  inspections of the trials by representatives of the Member States and of the Commission. 2.  It may be decided in accordance with the procedure laid down in Article 21 that it is necessary  to carry out Community trials or tests for the same purpose as mentioned in paragraph 1. The  Commission may organize inspections of Community trials by representatives of the Member States and  of the Commission. 3.  The trials or tests referred to in paragraphs 1 and 2 shall be used to harmonize technical  methods of examination of propagating material and ornamental plants. Progress reports shall be  made on the trials or tests and sent in confidence to the Member States and to the Commission. 4.  The Commission shall ensure that, in appropriate cases, arrangements for coordinating, carrying  out and inspecting the trials referred to in paragraphs 1 and 2, and assessing their results, are  made within the Committee set up by Article 21. When plant health problems occur, the Commission  shall notify the Standing Committee on Plant Health. If necessary, specific arrangements shall be  adopted. Propagating material and ornamental plants produced in third countries shall be included  in the trials. Article 21Where reference is made to the procedure laid down in this Article, the Commission  shall be assisted by a Committee, referred to as the Standing Committee for Propagating Material  and Ornamental Plants, chaired by a representative of the Commission. The representative of the Commission shall submit to the Standing Committee a draft of the measures  to be taken. The Standing Committee shall deliver its opinion on the draft within a time limit  which the chairman may lay down according to the urgency of the matter. The opinion shall be  delivered by the majority laid down in Article 148 (2) of the EEC Treaty in the case of decisions  which the Council is required to adopt on a proposal from the Commission. The votes of the  representatives of the Member States within the Committee shall be weighted in the manner set out  in that Article. The chairman shall not vote. The Commission shall adopt measures which shall apply immediately. However, if these measures are  not in accordance with the opinion of the Standing Committee, they shall be communicated by the  Commission to the Council forthwith. In that event, the Commission may defer application of the  measures which it has decided for a period of not more than one month from the date of such  communication. The Council, acting by a qualified majority, may take a different decision within the time referred  to in the previous paragraph. Article 22Where reference is made to the procedure laid down in this Article, the Commission  shall be assisted by the Standing Committee for Propagating Materials and Ornamental Plants,  chaired by the representative of the Commission. The representative of the Commission shall submit to the committee a draft of the measures to be  taken. The committee shall deliver its opinion on the draft within a time limit which the chairman  may lay down according to the urgency of the matter. The opinion shall be delivered by the majority  laid down in Article 148 (2) of the EEC Treaty in the case of decisions which the Council is  required to adopt on a proposal from the Commission. The votes of the representatives of the Member  States within the Committee shall be weighted in the manner set out in that Article. The chairman  shall not vote. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the  Committee. If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion  is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the  measures to be taken. The Council shall act by a qualified majority. If, on the expiry of a period of three months from the date of referral to the Council, the Council  has not acted, the proposed measures shall be adopted by the Commission. Article 23Amendments to the schedules established pursuant to Article 4 and to the conditions  and detailed rules adopted for the implementation of this Directive shall be adopted in accordance  with the procedure laid down in Article 21. Article 241.  Member States shall ensure that propagating material and ornamental plants  produced in their territory and intended for marketing comply with the requirements of this  Directive. 2.  If it is found, at an official inspection, that propagating material or ornamental plants  cannot, by reason of non-compliance with a condition relating to plant health, be placed on the  market, the Member State concerned shall take appropriate official measures to eliminate any  consequent plant-health risk. Article 251.  Member States shall bring into force the laws, regulations or administrative  provisions necessary to comply with this Directive not later than 31 December 1992. They shall  forthwith inform the Commission thereof. When these measures are adopted by the Member States, they shall contain a reference to this  Directive or be accompanied by such reference on the occasion of their official publication. The  methods for making such reference shall be adopted by the Member States. 2.  As far as Articles 5 to 11, 14, 15, 17, 19 and 24 are concerned, the date of application for  each genera or species referred to in the Annex shall be adopted in accordance with the procedure  provided for in Article 21, when the schedule referred to in Article 4 is drawn up. These dates may  not fall after 1 January 1993. Article 26This Directive is addressed to the Member States. Done at Brussels, 19 December 1991. For the CouncilThe PresidentP. DANKERT(1) OJ N° C 52, 3. 3. 1990, p. 16  andOJ N° C 307, 27. 11. 1991, p. 15. (2) OJ N° C 240, 16. 9. 1991, p. 197. (3) OJ N° C 182, 23. 7. 1990, p. 21. (4) OJ N° L 26, 31. 1. 1977, p. 20. (5) See p. 29 of this Official Journal  ANNEX   List of genera and species referred to in Article 1 (2)     - Begonia x  hiemalis FotschElatior-Begonia- Pelargonium L. Pelargonium (zonale, ivy-leaved, regal)- Dendranthema x grandiflorum(Ramat.) Kitam. Chrysanthemum (florists chrysanthemum)- Dianthus caryophyllus L. and hybridsCarnation- Euphorbia  pulcherrima wild ex Kletsch- Gerbera L.Gerbera- Phoenix- Rosa- Citrus (ornamental)- Malus Miller (ornamental)Ornamental Apple-  Pinus nigra (ornamental)- Prunus L. (ornamental)Ornamental Cherry- Pyrus L.  (ornamental)Ornamental Pear- Lilium L. Lily- Gladiolus L. Gladiolus- Narcissus L. Daffodil.


Avis juridique important

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31999L0080

Commission Directive 1999/80/EC of 28 July 1999 including an active substance (azimsulfuron) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance)

Official Journal L 210 , 10/08/1999 P. 0013 - 0015

COMMISSION DIRECTIVE 1999/80/ECof 28 July 1999including an active substance (azimsulfuron) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market(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), as last amended by Commission Directive 1999/1/EC(2), hereafter referred to as the Directive, and in particular Article 6(1),(1) Whereas in accordance with Article 6(2) of Directive 91/414/EEC Italy received on 4 March 1996 an application from Du Pont de Nemours Italiana SpA, hereafter referred to as the applicant, for the inclusion of the active substance azimsulfuron in Annex I to the Directive;(2) Whereas in accordance with the provisions of Article 6(3) of the Directive the Commission confirmed in its Decision 97/164/EC(3) of 17 February 1997 that the dossier submitted for azimsulfuron could be considered as satisfying, in principle, the data and information requirements of Annex II and for a plant protection product containing this active substance, of Annex III to the Directive;(3) Whereas, in accordance with Article 5(1) of the Directive, an active substance should be included for a period not exceeding 10 years in Annex I when it may be expected that there will not be any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment;(4) Whereas for azimsulfuron, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of the Directive, for the uses proposed by the applicant; whereas Italy acting as nominated rapporteur Member State, has submitted to the Commission on 22 May 1997 the assessment report concerned;(5) Whereas the submitted report has been reviewed by the Member States and the Commission within the Standing Committee on Plant Health; whereas this review has been finalised on 2 July 1999 in the format of the Commission review report for azimsulfuron; whereas it may be necessary to update this report to take account of technical and scientific developments; whereas in such case the conditions for the inclusion of azimsulfuron in Annex I to Directive 91/414/EEC will also need to be amended pursuant to Article 6(1) of that Directive;(6) Whereas the dossier and the information from the review have also been submitted to the Scientific Committee on Plants for opinion; whereas this Committee has given its opinion on 4 February 1999; whereas this Committee identified potential risks to aquatic organisms and terrestrial non-target plants, whereas therefore appropriate risk mitigation measures must be taken(4);(7) Whereas it has appeared from the various examinations made that plant protection products containing the active substance concerned may be expected to satisfy in general the requirements laid down in Article 5(1)(a),(b) and (3) of the Directive, in particular with regard to the uses which were examined; whereas therefore it is necessary to include the active substance concerned in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing the active substance concerned can be granted in accordance with the provisions of the said Directive;(8) Whereas after inclusion a reasonable period is necessary to permit Member States to implement the provisions of Directive 91/414/EEC on plant protection products containing azimsulfuron and in particular to review, within this period, existing provisional authorisations or to grant, by the end of this period at the latest, new authorisations in accordance with the provisions of the Directive; whereas a longer period may also be required for plant protection products containing azimsulfuron and other active substances included in Annex I;(9) Whereas it is appropriate to provide that the finalised review report (except for confidential information in the meaning of Article 14 of the Directive) is kept available or made available by the Member States for consultation by any interested parties;(10) Whereas the review report is required for the proper implementation by the Member States, of several sections of the uniform principles laid down in Annex VI to the Directive, where these principles refer to the evaluation of the Annex II data which were submitted for the purpose of the inclusion of the active substance in Annex I of the Directive;(11) Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health delivered on 2 July 1999,HAS ADOPTED THIS DIRECTIVE:Article 1Azimsulfuron is hereby designated as an active substance in Annex I to Directive 91/414/EEC, as set out in the Annex hereto.Article 21. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive, at the latest by 1 April 2000.2. However, with regard to evaluation and decision-making pursuant to the uniform principles provided for in Annex VI to Council Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III thereto, the period laid down in the first paragraph is extended for existing provisional authorisations of plant protection products containing azimsulfuron to 1 April 2001.3. However for plant protection products containing azimsulfuron together with another active substance which is in Annex I to Directive 91/414/EEC, the period referred to in paragraph 1 is extended to the extent that a longer implementation period is provided for by the provisions laid down in the Directive concerning the inclusion of this other active substance in Annex I to Directive 91/414/EEC.4. Member States shall keep available the review report (except for confidential information in the meaning of Article 14 of the Directive) for consultation by any interested parties or shall make it available to them on specific request.5. When Member States adopt the measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be laid down by the Member States.Article 3This Directive shall enter into force on 1 October 1999.Article 4This Directive is addressed to the Member States.Done at Brussels, 28 July 1999.For the CommissionFranz FISCHLERMember of the Commission(1) OJ L 230, 19.8.1991, p. 1.(2) OJ L 21, 28.1.1999, p. 21.(3) OJ L 64, 5.3.1997, p. 17.(4) Opinion of the Scientific Committee on Plants regarding the inclusion of azimsulfuron in Annex I to Directive 91/414/EEC concerning the placing of plant protection products on the market (SCP/AZIM/002-Final 24/02/1999)ANNEXAZIMSULFURON1. Identity(IUPAC) 1-(4,6-dimethoxypyrimidin-2-yl)-3-[1-methyl-4-(2-methyl-2H-tetrazol-5-yl)-pyrazol-5-ylsulfonyl]-urea2. Particular conditions to be fulfilled:2.1. The active substance shall have a minimum purity of 980 g/kg technical product.2.2. Only uses as herbicide may be authorised.2.3. Aerial applications may not be authorised.2.4. Member States must pay particular attention to the impact on aquatic organisms and terrestrial non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures (for example, in rice cultivation minimum holding periods for water prior to discharge).2.5. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on azimsulfuron, and in particular the Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 2 July 1999 shall be taken into account.3. Expiry date of the inclusion: 1 October 2009.