Avis juridique important

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31998L0056

Council Directive 98/56/EC of 20 July 1998 on the marketing of propagating material of ornamental plants

Official Journal L 226 , 13/08/1998 P. 0016 - 0023

COUNCIL DIRECTIVE 98/56/EC of 20 July 1998 on the marketing of propagating material of ornamental plantsTHE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof,Having regard to the proposal from the Commission (1),Having regard to the opinion of the European Parliament (2),Having regard to the opinion of the Economic and Social Committee (3),(1) Whereas the production of ornamental plants occupies an important place in the agriculture of the Community;(2) 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;(3) Whereas the establishment of harmonised conditions at Community level will ensure that purchasers throughout the Community receive propagating material which is healthy and of good quality;(4) Whereas, so far as they relate to plant health, such harmonised conditions must be consistent with Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Member States of organisms harmful to plants or plant products and against their spread in the Community (4);(5) Whereas it is appropriate to establish Community rules for all genera and species of ornamental plants in the Community, with the exception of those covered by Council Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein (5);(6) 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 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;(7) Whereas the determination of plant health and quality standards for particular 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;(8) Whereas in the first instance it is the responsibility of the suppliers of propagating material to ensure that their products fulfil the conditions laid down in this Directive;(9) Whereas the competent authorities of the Member States, when carrying out controls and inspections, should ensure that suppliers fulfil those conditions;(10) Whereas Community control measures should be introduced to ensure uniform application in all the Member States of the standards laid down in this Directive;(11) Whereas it is in the interests of the purchasers of propagating material that the names of varieties or of groups of plants be known and that their identity be safeguarded;(12) 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 suppliers;(13) Whereas, in order to ensure the identity and orderly marketing of propagating material, 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;(14) Whereas rules should be established permitting, in the case of temporary supply difficulties, the marketing of propagating material subject to requirements less stringent than those contained in this Directive;(15) Whereas provisions should be made for authorising the marketing, within the Community, of propagating material produced in third countries, provided always it affords equivalent guarantees in all respects to propagating material produced in the Community and complying with Community rules;(16) Whereas, in order to harmonise technical methods of examination used in the Member States and to compare propagating material produced in the Community with those produced in third countries, comparative trials should be carried out to check compliance of propagating material with the requirements of this Directive;(17) 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; whereas such measures should be adopted by a procedure involving close cooperation between the Commission and the Member States within a Standing Committee for Propagating Material of Ornamental Plants;(18) Whereas Council Directive 91/682/EEC of 19 December 1991 on the marketing of ornamental plant propagating material and ornamental plants (6) established harmonised conditions at Community level to ensure that purchasers throughout the Community receive propagating material and ornamental plants which are healthy and of good quality;(19) Whereas Member States have experienced difficulties in the interpretation and transposition of the said Directive;(20) Whereas the said Directive was considered to be suitable for inclusion in the SLIM Initiative (Simpler Legislation for the Internal Market) which was launched by the Commission in May 1996;(21) Whereas the Ornamental Plants SLIM team made various recommendations aimed at simplifying the said Directive; whereas those recommendations are contained in the Communication from the Commission to the Council and the European Parliament on the SLIM Initiative;(22) Whereas those recommendations related to the persons to be controlled by the said Directive, the species to be covered by that Directive, varietal authenticity, the interrelationship with Directive 77/93/EEC and third country equivalence;(23) Whereas, after consideration of those recommendations it is desirable to amend certain provisions of Directive 91/682/EEC; whereas given the number of such amendments, the said Directive should be recast in the interests of clarity,HAS ADOPTED THIS DIRECTIVE:TITLE I SCOPE Article 1 1. This Directive shall apply to the marketing of propagating material of ornamental plants within the Community. This shall be without prejudice to the rules on protection of wild flora laid down by Regulation (EC) No 338/97, the rules on packaging and packaging waste laid down by Directive 94/62/EC of the European Parliament and of the Council (7), or, save where otherwise provided for in this Directive or on the basis thereof, the plant health rules laid down by Directive 77/93/EEC.2. This Directive shall not apply to:- material shown to be intended for export to third countries, which is identified as such and is kept sufficiently isolated,- material the products of which are not intended for ornamental purposes, if it is covered by other Community legislation on the marketing of such material.3. In accordance with the procedure laid down in Article 17, it may be decided that some or all of the requirements of this Directive shall not apply in respect of seed of particular species or groups of plants, where intended for the production of further propagating material and where there is no significant connection between the quality of such seed and the quality of the material grown from it.TITLE II DEFINITIONS Article 2 For the purpose of this Directive, the following definitions shall apply:1. 'Propagating material`: plant material intended for:- the propagation of ornamental plants, or- the production of ornamental plants; however, in the case of production from complete plants, this definition applies only to the extent that the resulting ornamental plant is intended for further marketing.'Propagation`: reproduction by vegetative or other means.2. 'Supplier`: any natural or legal person engaged professionally in marketing or importing of propagating material.3. 'Marketing`: sale or delivery by a supplier to another person. 'Sale` includes holding available or in stock, display with a view to sale, offering for sale.4. 'Responsible official body`:(a) an authority, established or designated by the Member State under the supervision of the national government and responsible for questions concerning quality;(b) 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 above 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.Moreover, in accordance with the procedure laid down in Article 17, other legal persons established on behalf of the body referred to in point (a) 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.5. 'Lot`: a number of units of a single commodity, identifiable by its homogeneity of composition and origin.TITLE III REQUIREMENTS TO BE MET BY PROPAGATING MATERIAL Article 3 1. Suppliers may market propagating material only if it meets the requirements laid down in this Directive.2. Paragraph 1 shall not apply to propagating material intended for:(a) trials or scientific purposes,(b) selection work, or(c) the conservation of genetic diversity.3. Detailed rules for the application of paragraph 2 may be adopted in accordance with the procedure laid down in Article 17.Article 4 Propagating material shall, where applicable, comply with the relevant plant health conditions laid down in Directive 77/93/EEC.Article 5 1. Without prejudice to the provisions of Article 1 and Article 4, propagating material when marketed:- shall at least on visual inspection, be substantially free from any harmful organisms impairing quality, or any signs or symptoms thereof, which reduce its usefulness,- shall be substantially free of any defects likely to impair its quality as propagating material,- shall have satisfactory vigour and dimensions in respect of its usefulness as propagating material,- in the case of seeds, shall have satisfactory germination capacity,- if marketed with reference to a variety pursuant to Article 9, shall have satisfactory varietal identity and purity.2. Any propagating material which, on the basis of visible signs or symptoms, is not substantially free of harmful organisms, shall be properly treated or, where appropriate, shall be removed.3. In the case of citrus material the following requirements shall also be met:(a) it shall be derived from initial material which has been checked and found to show no symptoms of any viruses, virus-like organisms or diseases;(b) it shall have been checked and found to be substantially free of such viruses, virus-like organisms or disease since the beginning of the last cycle of vegetation; and(c) in the case of grafting, it shall have been grafted onto rootstocks other than those susceptible to viroids.4. In the case of flower bulbs the following requirement shall also be met:- the propagating material shall be derived directly from material which, at the stage of the growing crop, has been checked and found to be substantially free from any harmful organisms and diseases, signs or symptoms thereof.5. In accordance with the procedure laid down in Article 18, a schedule may be established for a particular genus or species, laying down additional conditions concerning the quality with which propagating material when marketed must comply. A genus or species shall only be included in the schedule if there is a demonstrated need for such additional rules. In determining such need the following criteria shall apply:- the existence of problems with the quality of propagating material of the species or genus concerned, which can only be resolved satisfactorily through legislative means,- the economic importance of propagating material of the species or genus concerned,- consistency with any international standards on regulated non-quarantine pests.TITLE IV REQUIREMENTS TO BE MET BY SUPPLIERS OF PROPAGATING MATERIAL Article 6 1. Without prejudice to paragraph 2, suppliers shall be officially registered in relation to the activities which they carry out under this Directive. The responsible official body may deem suppliers, who are already registered under Directive 77/93/EEC, to be registered for the purposes of the current Directive. Such suppliers shall nonetheless comply with the requirements of the current Directive.2. Paragraph 1 shall not apply to suppliers marketing only to persons not professionally engaged in the production or sale of ornamental plants or propagating material. Such suppliers shall nonetheless comply with the requirements of the current Directive.Article 7 1. Suppliers engaged in production of propagating material shall:- identify and monitor critical points in their production process which influence the quality of the material,- keep information, for examination when requested by the responsible official body on the monitoring laid down in the first indent,- take samples where necessary for analysis in a laboratory with suitable facilities and expertise,- ensure that, during production, lots of propagating material remain separately identifiable.2. In the case of the appearance, on the premises of a supplier engaged in the production of propagating material, of a harmful organism listed in Directive 77/93/EEC or in any measures established pursuant to Article 5(5), the supplier shall report it to the responsible official body and shall carry out any measures laid down by that body.3. When propagating material is marketed, registered suppliers shall keep records of their sales or purchases for at least 12 months.4. Rules for the application of paragraph 1 above may be established in accordance with the procedure laid down in Article 17.TITLE V MARKETING AND LABELLING OF PROPAGATING MATERIAL Article 8 1. Propagating material shall be marketed in lots. However, propagating material of different lots may be marketed in a single consignment, provided that the supplier keeps records of the composition and origin of the different lots.2. Propagating material when marketed shall be accompanied by a label or other document made out by the supplier.3. In accordance with the procedure laid down in Article 17, requirements as to the label or document referred to in paragraph 2 shall be established. In the case of marketing of propagating material for persons not professionally engaged in the production or sale of ornamental plants or propagating material, requirements on labelling may be confined to appropriate product information. Requirements as to packaging of propagating material may be adopted in accordance with the same procedure.4. Paragraph 1 shall not apply to propagating material which is marketed for persons not professionally engaged in the production or sale of ornamental plants or propagating material.Article 9 1. Propagating material may be marketed with a reference to a variety, only if the variety concerned is:- legally protected by a plant variety right in accordance with provisions on the protection of new varieties, or- officially registered, or- commonly known, or- entered on a list kept by a supplier with its detailed description and denomination. Such lists shall be drawn up in accordance with accepted international guidelines, where these are applicable. The lists shall be available, on request, to the responsible official body of the Member State concerned.2. As far as possible, each variety shall bear the same denomination in all the Member States, in accordance with implementing measures which may be adopted in accordance with the provisions of Article 17 or, in their absence, in accordance with accepted international guidelines.3. Where propagating material is marketed with a reference to a group of plants rather than a variety referred to in paragraph 1, the supplier shall indicate the group of plants in such a way as to avoid confusion with any varietal denomination.4. Additional implementing provisions for the fourth indent of paragraph 1 may be adopted in accordance with the procedure laid down in Article 17.TITLE VI PROPAGATING MATERIAL MEETING LESS STRINGENT REQUIREMENTS Article 10 In the event of temporary difficulties in the supply of propagating material satisfying the requirements of this Directive which cannot be overcome within the Community, rules may be adopted, in accordance with the procedure laid down in Article 17, concerning the marketing of propagating material meeting less stringent requirements.TITLE VII PROPAGATING MATERIAL PRODUCED IN THIRD COUNTRIES Article 11 1. In accordance with the procedure laid down in Article 17, it shall be decided whether propagating material produced in a third country affords equivalent guarantees in all respects to material produced in the Community in accordance with this Directive.2. Pending the decision referred to in paragraph 1, propagating material may not be imported from third countries unless the importing supplier ensures prior to import that the material to be imported affords equivalent guarantees in all respects to propagating material produced in the Community in accordance with this Directive, in particular in relation to quality, identification and plant health.3. The importer shall notify the responsible official bodies of material imported under paragraph 2 and shall keep documentary evidence of his contract with the supplier in the third country.4. Implementing measures relating to the procedure to be followed and further requirements to be met by importers may be established in accordance with the procedure laid down in Article 17.TITLE VIII CONTROL MEASURES AND GENERAL PROVISIONS Article 12 1. Member States shall require that suppliers take all necessary measures to guarantee compliance with the requirements of this Directive. To this end Member States shall ensure that propagating material is officially inspected:- at least by random checks, and- at least in respect of marketing to persons professionally engaged in production or sale of ornamental plants or propagating material,to verify compliance with the requirements. Member States may also take samples in order to verify compliance. In carrying out supervision and monitoring, the responsible official bodies shall have free access to all parts of suppliers' establishments at all reasonable times.The Commission shall, by 31 December 2002, submit a report to the Council, on the operation of the control arrangements foreseen in this Article, together with any appropriate proposals which may, if appropriate, include proposals for removing requirements of this Directive from retail sales.2. Detailed implementing procedures for official inspections under this Directive may be established in accordance with the procedure laid down in Article 17.Article 13 1. If, during official inspections referred to in Article 12, or the trials referred to in Article 14, it is found that propagating material does not meet the requirements of this Directive, the responsible official body shall ensure that the supplier takes appropriate corrective action or, if that is not possible, shall prohibit the marketing of that propagating material in the Community.2. If it is found that propagating material marketed by a particular supplier does not comply with the requirements of this Directive, the Member State concerned shall ensure that appropriate measures are taken in relation to that supplier.3. Any measures taken under paragraph 2 shall be withdrawn as soon as it has been established with sufficient certainty that the propagating material intended for marketing by the supplier will, in future, comply with the requirements and conditions of this Directive.Article 14 1. Where appropriate, trials or tests shall be carried out in the Member States on samples to check that propagating material complies with the requirements and conditions of this Directive. The Commission may organise inspections of 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 17 that it is necessary to carry out Community trials or tests for the same purpose as mentioned in paragraph 1. The Commission may organise 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 harmonise technical methods of examination of propagating material. Progress reports on the trials or tests shall be sent to the Commission and submitted to the Committee referred to in Article 17.4. 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 referred to in Article 17. When problems occur in relation to organisms covered by Directive 77/93/EEC, the Commission shall notify the Standing Committee on Plant Health, which shall also be consulted on protocols for Community trials where these concern organisms covered by Directive 77/93/EEC. Propagating material produced in third countries may be included in the trials.Article 15 The marketing of propagating material which complies with the requirements of this Directive shall be subject to no restrictions as regards supplier, quality, plant health, labelling and packaging, other than those laid down in this Directive.Article 16 In accordance with the procedure laid down in Article 17, a Member State may at its request and under certain conditions be wholly or partially released from certain obligations under this Directive in respect of types of propagating material of certain genera or species the production of which is of minimal economic importance in its territory, save where this would run counter to Article 15.TITLE IX COMMITTEE PROCEDURES Article 17 1. Where 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 of Ornamental Plants, chaired by a representative of the Commission.2. 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 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.3. (a) The Commission shall adopt measures which shall apply immediately.(b) However, if these measures are not in accordance with the opinion of the 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 first indent.4. The Committee, at the request of the chairman or one of the Member States, may examine any questions relevant to the subject matter of this Directive.Article 18 1. Where 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.2. 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 will be delivered by the majority laid down in Article 148(2) of the 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.3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.(b) 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.TITLE X FINAL PROVISIONS Article 19 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive on 1 July 1999. 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 for making such reference shall be adopted by the Member States.3. Member States shall communicate to the Commission the text of the main provisions of domestic law they adopt in the field covered by this Directive.Article 20 1. Directive 91/682/EEC shall be repealed with effect from 1 July 1999 without prejudice to Member States' obligations in relation to the period of transposition and implementation referred to in Part A of the Annex hereto.2. References to the repealed Directive 91/682/EEC shall be understood as references to this Directive and shall be read in accordance with the correlation table in Part B of the Annex hereto.3. Implementing provisions adopted under Directive 91/682/EEC shall continue to have effect unless amended or repealed by new implementing provisions.Article 21 This Directive is addressed to the Member States.Done at Brussels, 20 July 1998.For the CouncilThe PresidentW. MOLTERER(1) OJ C 50, 17. 2. 1998, p. 8.(2) OJ C 104, 6. 4. 1998, p. 40.(3) OJ C 157, 25. 5. 1998, p. 3.(4) OJ L 26, 31. 1. 1977, p. 20. Directive as last amended by Commission Directive 98/2/EC (OJ L 15, 21. 1. 1998, p. 34).(5) OJ L 61, 3. 3. 1997, p. 1. Regulation as amended by Commission Regulation (EC) No 938/97 (OJ L 140, 30. 5. 1997, p. 1).(6) OJ L 376, 31. 12. 1991, p. 21.(7) OJ L 365, 31. 12. 1994, p. 10.ANNEX PART A>TABLE>PART B>TABLE>


title: Commission Directive 2011/20/EU of 2 March 2011 amending Council Directive 91/414/EEC to include fenoxycarb as active substance and amending Decision 2008/934/EC  Text with EEA relevance

text:
               3.3.2011

               EN

               Official Journal of the European Union

               L 58/45

         COMMISSION DIRECTIVE 2011/20/EU
   of 2 March 2011
   amending Council Directive 91/414/EEC to include fenoxycarb as active substance and amending Decision 2008/934/EC
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

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

               (2)

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

               (3)

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

               (4)

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

               (5)

               The Netherlands evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 10 December 2009. The Authority communicated the additional report to the other Member States and the applicant for comments and forwarded the comments it had received to the Commission. In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on fenoxycarb to the Commission on 13 September 2010 (6). The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 28 January 2011 in the format of the Commission review report for fenoxycarb.

               (6)

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

               (7)

               Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore, it is appropriate to require that the applicant submit information confirming the risk assessment for non-target arthropods and for bee brood.

               (8)

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

               (9)

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

               (10)

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

               (11)

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

               (12)

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

               (13)

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

               (14)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   The line concerning fenoxycarb in the Annex to Decision 2008/934/EC is deleted.
   Article 3
   Member States shall adopt and publish by 30 November 2011 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 December 2011.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 4
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing fenoxycarb as an active substance by 30 November 2011.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to fenoxycarb 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 fenoxycarb as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 May 2011 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning fenoxycarb. 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 fenoxycarb as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2015 at the latest; or

               (b)

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

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

      Done at Brussels, 2 March 2011.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 55, 29.2.2000, p. 25.

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

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

      (5)  OJ L 15, 18.1.2008, p. 5.

      (6)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance fenoxycarb. EFSA Journal 2010; 8(12):1779. [75 pp.]. doi:10.2903/j.efsa.2010.1779. Available online: www.efsa.europa.eu

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

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

                     No

                     Common name, identification numbers

                     IUPAC name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘339

                     Fenoxycarb
                     CAS No:
                     79127-80-3
                     CIPAC No: 425

                     Ethyl 2-(4-phenoxyphenoxy)ethyl-carbamate

                     ≥ 970 g/kg
                     Impurities:
                     Toluene: max. 1 g/kg

                     1 June 2011

                     31 May 2021

                     PART A
                     Only uses as insecticide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on fenoxycarb, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 —

                                 the protection of aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate,

                                 —

                                 the risk to bees and non-target arthropods. Conditions of authorisation shall include risk mitigation measures, where appropriate.

                           The Member States concerned shall request the submission of information confirming the risk assessment for non-target arthropods and for bee brood.
                     The Member States concerned shall ensure that the applicant submits such information to the Commission by 31 May 2013.’

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


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31985L0322

Council Directive 85/322/EEC of 12 June 1985 amending Directive 72/461/EEC as regards certain measures relating to classical swine fever and African swine fever

Official Journal L 168 , 28/06/1985 P. 0041 - 0042 Finnish special edition: Chapter 3 Volume 18 P. 0202  Spanish special edition: Chapter 03 Volume 35 P. 0174  Swedish special edition: Chapter 3 Volume 18 P. 0202  Portuguese special edition Chapter 03 Volume 35 P. 0174

*****COUNCIL  DIRECTIVE  of 12 June 1985  amending Directive 72/461/EEC as regards certain measures relating to classical swine fever and African swine fever  (85/322/EEC)  THE COUNCIL OF THE EUROPEAN  COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 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 Directive 72/461/EEC (4), as last amended by Directive 84/643/EEC (5), lays down the health requirements to be fulfilled by animals from which meat is obtained for intra-Community trade;  Whereas, in view of the development of classical swine fever in certain parts of the territory of the Community, the measures relating to trade should be strengthened and the circumstances in which the status of the officially swine-fever-free regions should be altered in the event of an outbreak of the disease should be more clearly defined;  Whereas, even if it occurs only exceptionally in certain parts of the territory of the Community, African swine fever constitutes a danger of contamination to the pig herds of the Member States; whereas rules should therefore be established laying down protective measures to be applied in intra-Community trade in fresh pigmeat,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Directive 72/461/EEC is hereby amended as follows:  1. The following subparagraph is added to Article 8 (1):  'However, when the disease in question is African swine fever, Article 8a shall apply.'  2. The following Article is inserted:  'Article 8a  1. A Member State in whose territory African swine fever has been recorded within the previous 12 months shall not export fresh pigmeat to the territory of the other Member States.  It may be decided, in accordance with the procedure laid down in Article 9, that the provisions of the first subparagraph shall not apply to one or more parts of the territory of the Member State concerned. This derogation shall not preclude recourse to Article 6 should one or more cases of African swine fever reoccur in the above part or parts of territory.  2. Where there is an outbreak of African swine fever in the territory of a Member State where the disease has not been recorded for at least 12 months, it may be decided, in accordance with the procedure laid down in Article 9, that the provisions of paragraph 1 shall apply exclusively to a part of territory concerned. Pending this decision, and without prejudice to Article 8, the Member State concerned shall ensure the immediate prohibition of export to the other Member States of fresh pigmeat from the part of territory in which the epizootic disease has been recorded. The criteria laid down in Article 8b (2) shall be taken into account in determining that part of the territory.  One or more cases of African swine fever on a part of a Member State's territory which is not geographically linked to the main part of that Member State's territory shall not prevent the application of the first subparagraph.  The conditions prerequisite to the application of the first subparagraph shall still be deemed to be fulfilled if the following conditions have been fulfilled:  (i) the outbreak or outbreaks recorded on the occurrence of African swine fever referred to in the first sub-paragraph was or were eradicated in the shortest possible period of time;  (ii) the new outbreak, which forms the subject of a fresh request for a decision, as provided for in the first subparagraph, is not connected epidemiologically with the outbreak or outbreaks referred to in (i).  3. Decisions to lift measures applied under paragraph 2 shall be taken in accordance with the procedure laid down in Article 9.'  3. The following Article is inserted:  'Article 8b  1. For the purposes of defining the parts of territory referred to in Article 8a (1), particular account shall be taken of:  - the methods used to control and eradicate African swine fever,  - the absence of the disease for at least 12 months, recorded by all the methods of detection, including serological surveys,  - the surface area of the parts of territory and their administrative and geographical boundaries,  - the protective measures taken to prevent the contamination or re-contamination of pig herds,  - the measures taken to control the movement of pigs.  2. For the purposes of defining the parts of territory referred to in Article 8a (2), particular account shall be taken of:  - the methods used to combat the disease, in particular the elimination of pigs from holdings which are infected, contaminated or suspected of contamination,  - the surface area of the parts of territory and their administrative and geographical boundaries,  - the incidence of the disease and its tendency to spread,  - the measures taken to prevent the disease from spreading,  - the measures taken to restrict and control the movement of pigs both inside and outside the part of territory concerned.'  4. Article 13a (2) is replaced by the following:  '2. Acting unanimously on a proposal from the Commission, within three months of the date on which the proposal is referred to it, the Council shall draw up the list of the Member States and parts of territory referred to in paragraph 1 (ii) which are swine-fever-free.  Without prejudice to the possibility of recourse to Article 8, the Member States in question shall suspend this status upon the occurrence of an outbreak of swine fever and shall forthwith inform the Commission and the other Member States thereof, The Member State concerned shall lift the suspension either 30 days after the eradication of the last outbreak of the disease if there has been no vaccination or 90 days after the eradication of the last outbreak of the disease if there has been a vaccination. It shall inform the Commission and the other Member States of the end of the period of suspension. When two months have elapsed between the dates on which the first and last outbreaks were detected, the Member State concerned shall forthwith inform the Commission thereof. In this case, the status may be withdrawn in accordance with the procedure laid down in Article 9.  In the event of withdrawal, the status may be granted afresh to the part of territory in question in accordance with the same procedure only after a period of not less than:  - three months after the eradication of the last outbreak of the disease if there has been no vaccination,  - six months after the eradication of the last outbreak of the disease if there has been vaccination.  3. This Article shall be applicable until 31 December 1987.  By 1 July 1987 the Commission shall submit to the Council a report on development in the situation with particular regard to trade, together with appropriate proposals as regards swine fever.  The Council shall take a decision on these proposals not later than 31 December 1987.'  Article 2  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than January 1986.  They shall forthwith inform the Commission thereof.  Article 3  This Directive is addressed to the Member States.  Done at Luxembourg, 12 June 1985.  For the Council  The President  C. DEGAN  (1) OJ No C 272, 12. 10. 1984, p. 6.  (2) OJ No C 12, 14. 1. 1985, p. 127.  (3) OJ No C 44, 15. 2. 1985, p. 4.  (4) OJ No L 302, 31. 12. 1979, p. 24.  (5) OJ No L 339, 27. 12. 1984, p. 27.


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31976L0893

Council Directive 76/893/EEC of 23 November 1976 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs

Official Journal L 340 , 09/12/1976 P. 0019 - 0024 Greek special edition: Chapter 03 Volume 33 P. 0102  Spanish special edition: Chapter 13 Volume 5 P. 0259  Portuguese special edition Chapter 13 Volume 5 P. 0259

++++ ( 1 ) OJ N C 155 , 9 . 12 . 1974 , P . 10 .   ( 2 ) OJ N C 108 , 15 . 5 . 1975 , P . 72 .   ( 3 ) OJ N L 136 , 20 . 5 . 1974 , P . 1 .   ( 4 ) OJ N L 291 , 19 . 11 . 1969 , P . 9 .  COUNCIL DIRECTIVE  OF 23 NOVEMBER 1976  ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO MATERIALS AND ARTICLES INTENDED TO COME INTO CONTACT WITH FOODSTUFFS   ( 76/893/EEC )  THE COUNCIL OF THE EUROPEAN COMMUNITIES ,  HAVING REGARD TO THE TREATY ESTABLISHING THE EUROPEAN ECONOMIC COMMUNITY , AND IN PARTICULAR ARTICLES 100 AND 227 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 LAWS RELATING TO MATERIALS AND ARTICLES INTENDED , IN THEIR FINISHED STATE , TO COME INTO CONTACT WITH PRODUCTS FOR HUMAN CONSUMPTION SHOULD TAKE ACCOUNT PRIMARILY OF HUMAN HEALTH REQUIREMENTS BUT ALSO , WITHIN THE LIMITS REQUIRED FOR THE PROTECTION OF HEALTH , OF ECONOMIC AND TECHNOLOGICAL NEEDS ;  WHEREAS THE MANUFACTURE AND SALE OF THESE MATERIALS AND ARTICLES ARE OF CONSIDERABLE IMPORTANCE IN THE COMMON MARKET ;  WHEREAS THE EXISTING DIFFERENCES BETWEEN THE NATIONAL LAWS RELATING TO THE AFORESAID MATERIALS AND ARTICLES IMPEDE THE FREE MOVEMENT THEREOF , MAY CREATE UNEQUAL CONDITIONS OF COMPETITION AND MAY THEREBY DIRECTLY AFFECT THE ESTABLISHMENT OR FUNCTIONING OF THE COMMON MARKET ;  WHEREAS THESE LAWS MUST BE APPROXIMATED IF FREE MOVEMENT IS TO BE ACHIEVED FOR THE AFORESAID MATERIALS AND ARTICLES ;  WHEREAS THE FIRST STEP SHOULD BE TO LAY DOWN , IN A FRAMEWORK DIRECTIVE , GENERAL PRINCIPLES ON THE BASIS OF WHICH LEGAL DIFFERENCES MAY SUBSEQUENTLY BE ELIMINATED BY MEANS OF SPECIFIC DIRECTIVES ;  WHEREAS COVERING OR COATING SUBSTANCES , ALL OR PART OF WHICH FROM PART OF FOODSTUFFS , CANNOT BE CONSIDERED AS BEING SIMPLY IN CONTACT WITH THESE FOODSTUFFS ; WHEREAS , IN SUCH A CASE , ACCOUNT SHOULD BE TAKEN OF POSSIBLE DIRECT CONSUMPTION BY CONSUMERS ; WHEREAS THE RULES LAID DOWN IN THIS DIRECTIVE ARE THEREFORE UNSUITABLE IN SUCH CIRCUMSTANCES ;  WHEREAS PENDING A COMMUNITY DEFINITION OF FOODSTUFFS THIS SHALL CONTINUE TO COME WITHIN THE JURISDICTION OF NATIONAL LEGISLATION ; WHEREAS , HOWEVER , IT APPEARS NECESSARY ALREADY TO SPECIFY WHICH MATERIALS AND ARTICLES IN CONTACT WITH WATER INTENDED FOR HUMAN CONSUMPTION ARE SUBJECT TO THE PROVISIONS OF THIS DIRECTIVE ;  WHEREAS THIS DIRECTIVE APPLIES ONLY TO THE BEHAVIOUR OF MATERIALS AND ARTICLES IN THE PRESENCE OF FOODSTUFFS WITH WHICH THEY COME INTO CONTACT AND DOES NOT AFFECT THE PROVISIONS CONCERNING POSSIBLE EFFECTS RESULTING FROM DIRECT CONTACT WITH THE HUMAN BODY ; WHEREAS , HOWEVER , IT SHOULD BE POSSIBLE IF NECESSARY TO ADOPT , IN SPECIFIC DIRECTIVES , PROVISIONS WHICH APPLY TO PARTS OF CERTAIN ARTICLES WHICH , WHEN USED , COME INTO CONTACT SIMULTANEOUSLY WITH THE MOUTH AND WITH FOODSTUFFS ;  WHEREAS , THEREFORE , THE PRINCIPLE UNDERLYING THIS DIRECTIVE SHOULD BE THAT ANY MATERIAL OR ARTICLE INTENDED TO COME INTO CONTACT EITHER DIRECTLY OR INDIRECTLY WITH FOODSTUFFS MUST BE SUFFICIENTLY STABLE NOT TO TRANSFER SUBSTANCES TO THE FOODSTUFFS IN QUANTITIES WHICH COULD ENDANGER HUMAN HEALTH OR BRING ABOUT AN UNACCEPTABLE CHANGE IN THE COMPOSITION OF THE FOODSTUFFS OR A DETERIORATION IN THE ORGANOLEPTIC CHARACTERISTICS THEREOF ;  WHEREAS , IN ORDER TO ACHIEVE THIS OBJECTIVE , IT MAY OCCASIONALLY PROVE NECESSARY TO LIST THOSE SUBSTANCES ( INDICATING PURITY STANDARDS AND CONDITIONS OF USE ) WHICH MAY BE USED IN THE MANUFACTURE OF THE MATERIALS AND ARTICLES CONCERNED AND TO LAY DOWN OVERALL AND / OR SPECIFIC MIGRATION OR OTHER LIMITS ;  WHEREAS SPECIFIC DIRECTIVES SHOULD INDICATE THOSE PROVISIONS REFERRED TO IN THE FRAMEWORK DIRECTIVE WHICH ARE MOST SUITABLE FOR ACHIEVING THE OBJECTIVE LAID DOWN , HAVING REGARD TO THE TECHNOLOGICAL CHARACTERISTICS OF EACH GROUP OF MATERIALS AND ARTICLES ;  WHEREAS , IN ORDER THAT CONSUMERS MAY BE PROPERLY INFORMED AS TO THEIR CORRECT USE , ARRANGEMENTS SHOULD BE MADE FOR MATERIALS AND ARTICLES RETAILED IN AN EMPTY STATE TO BEAR INTER ALIA THE INDICATION " FOR FOOD USE " OR MORE SPECIFIC PARTICULARS REGARDING THEIR USE OR AN AGREED SYMBOL ; WHEREAS MEMBER STATES SHOULD , HOWEVER , BE PERMITTED NOT TO REQUIRE SUCH INDICATION IN THE CASE OF MATERIALS AND ARTICLES FOR WHICH NEITHER SPECIFIC COMMUNITY DIRECTIVES NOR NATIONAL PROVISIONS EXIST ;  WHEREAS THIS DIRECTIVE DOES NOT APPLY TO THE LABELLING OF PRODUCTS WHICH , BY REASON OF THEIR BEHAVIOUR IN THE PRESENCE OF FOODSTUFFS , MAY NOT COME INTO CONTACT WITH THEM ;  WHEREAS , IN ORDER TO ENCOURAGE TECHNICAL PROGRESS , MEMBER STATES SHOULD BE ALLOWED TO PERMIT PROVISIONALLY IN THEIR TERRITORY , UNDER OFFICIAL CONTROL , THE USE OF SUBSTANCES NOT PROVIDED FOR IN ONE OF THE SPECIFIC DIRECTIVES , PENDING A FINAL DECISION AT COMMUNITY LEVEL ;  WHEREAS , SHOULD THE USE IN A MATERIAL OR ARTICLE OF A SUBSTANCE PROVIDED FOR IN ONE OF THE SPECIFIC DIRECTIVES APPEAR TO CONSTITUTE A HEALTH RISK , MEMBER STATES SHOULD BE AUTHORIZED TO SUSPEND OR LIMIT SUCH USE PENDING A DECISION AT COMMUNITY LEVEL ;  WHEREAS THE UPDATING OF THE LIST OF SUBSTANCES AUTHORIZED IN THE MANUFACTURE OF THE MATERIALS AND ARTICLES , AND THE ESTABLISHMENT OF SAMPLING PROCEDURES AND OF THE METHODS OF ANALYSIS REQUIRED FOR CHECKING NOT ONLY THE SUBSTANCES LISTED , THEIR PURITY STANDARDS AND CONDITIONS OF USE BUT ALSO THE OVERALL AND SPECIFIC MIGRATION LIMITS WHICH HAVE BEEN LAID DOWN , CONSTITUTE TECHNICAL IMPLEMENTING MEASURES ; WHEREAS , IN ORDER TO SIMPLIFY AND EXPEDITE THE PROCEDURE , THE ADOPTION OF THESE MEASURES SHOULD BE ENTRUSTED TO THE COMMISSION AS REGARDS THE SAID UPDATING INASMUCH AS THE SPECIFIC DIRECTIVES PROVIDE FOR THIS , AND AS REGARDS THE SAMPLING PROCEDURES AND THE METHODS OF ANALYSIS INASMUCH AS THE SAID DIRECTIVES DO NOT PROVIDE OTHERWISE ; IN THE CASE OF THE UPDATING PROCEDURE THE SCIENTIFIC COMMITTEE FOR FOOD , SET UP BY DECISION 74/234/EEC ( 1 ) SHOULD , WHERE APPROPRIATE , BE CONSULTED ;  WHEREAS , IT IS DESIRABLE THAT FOR ALL CASES WHERE THE COUNCIL EMPOWERS THE COMMISSION TO IMPLEMENT RULES RELATING TO MATERIALS AND ARTICLES INTENDED TO COME INTO CONTACT WITH FOODSTUFFS , PROVISION SHOULD BE MADE FOR A PROCEDURE ESTABLISHING CLOSE COOPERATION BETWEEN THE MEMBER STATES AND THE COMMISSION WITHIN THE STANDING COMMITTEE FOR FOODSTUFFS SET UP BY DIRECTIVE 69/414/EEC ( 2 ) ;  WHEREAS , TO ENABLE THE PROCESSES USED IN THE MANUFACTURE OF THE MATERIALS AND ARTICLES CONCERNED TO BE ADAPTED TO THE NEW REQUIREMENTS LAID DOWN IN THE FOLLOWING PROVISIONS , THE RULES SHOULD BE APPLIED IN SUCH A WAY AS TO AUTHORIZE , TWO YEARS AFTER NOTIFICATION OF THIS DIRECTIVE , TRADE IN MATERIALS AND ARTICLES COMPLYING WITH THE PROVISIONS OF THIS DIRECTIVE AND TO PROHIBIT , THREE YEARS AFTER THE NOTIFICATION THEREOF , TRADE IN AND USE OF MATERIALS AND ARTICLES WHICH DO NOT COMPLY THEREWITH ,  HAS ADOPTED THIS DIRECTIVE :  ARTICLE 1  1 . THIS DIRECTIVE SHALL APPLY TO MATERIALS AND ARTICLES WHICH IN THEIR FINISHED STATE ARE INTENDED TO COME INTO CONTACT WITH FOODSTUFFS OR WHICH ARE IN CONTACT WITH FOODSTUFFS AND ARE INTENDED FOR THAT PURPOSE . THEY ARE HERINAFTER REFERRED TO AS " MATERIALS AND ARTICLES " .  COVERING OR COATING SUBSTANCES , SUCH AS THE SUBSTANCES COVERING CHEESE RINDS , PREPARED MEAT PRODUCTS OF FRUIT , WHICH FORM PART OF FOODSTUFFS AND MAY BE CONSUMED TOGETHER WITH THE FOOD , SHALL NOT BE SUBJECT TO THIS DIRECTIVE .  2 . THIS DIRECTIVE SHALL APPLY TO MATERIALS AND ARTICLES WHICH ARE IN CONTACT WITH WATER INTENDED FOR HUMAN CONSUMPTION . IT SHALL NOT , HOWEVER , APPLY TO FIXED PUBLIC OR PRIVATE WATER SUPPLY EQUIPMENT .  3 . MEMBER STATES MAY DEROGATE , WHOLLY OR PARTIALLY , FROM THIS DIRECTIVE AS REGARDS ANTIQUES .  ARTICLE 2  MATERIALS AND ARTICLES MUST BE MANUFACTURED IN COMPLIANCE WITH GOOD MANUFACTURING PRACTIVE , SO THAT , UNDER THEIR NORMAL OR FORESEEABLE CONDITIONS OF USE , THEY DO NOT TRANSFER THEIR CONSTITUENTS TO FOODSTUFFS IN QUANTITIES WHICH COULD :   _ ENDANGER HUMAN HEALTH ,   _ BRINB ABOUT AN UNACCEPTABLE CHANGE IN THE COMPOSITION OF THE FOODSTUFFS OR A DETERIORATION IN THE ORGANOLEPTIC CHARACTERISTICS THEREOF .  ARTICLE 3  THE COUNCIL SHALL , UNDER THE PROCEDURE PROVIDED FOR IN ARTICLE 100 OF THE TREATY , ADOPT BY MEANS OF DIRECTIVES SPECIAL PROVISIONS APPLICABLE TO CERTAIN GROUPS OF MATERIALS AND ARTICLES ( SPECIFIC DIRECTIVES ) .  SUCH SPECIFIC DIRECTIVES MAY INCLUDE :   ( A ) IF POSSIBLE AND IF NECESSARY , A LIST OF THE SUBSTANCES THE USE OF WHICH IS AUTHORIZED TO THE EXCLUSION OF ALL OTHERS ;   ( B ) PURITY STANDARDS FOR SUCH SUBSTANCES ;   ( C ) SPECIAL CONDITIONS OF USE FOR THESE SUBSTANCES AND / OR THE MATERIALS AND ARTICLES IN WHICH THEY ARE USED ;   ( D ) SPECIFIC LIMITS ON THE MIGRATION OF CERTAIN CONSTITUENTS OR GROUPS OF CONSTITUENTS INTO OR ONTO FOODSTUFFS ;   ( E ) AN OVERALL LIMIT ON THE MIGRATION OF CONSTITUENTS INTO OR ONTO FOODSTUFFS ;   ( F ) IF NECESSARY , PROVISIONS AIMED AT PROTECTING HUMAN HEALTH AGAINST ANY HAZARDS WHICH MIGHT ARISE THROUGH ORAL CONTACT WITH THESE MATERIALS AND ARTICLES ;   ( G ) OTHER RULES TO ENSURE COMPLIANCE WITH ARTICLE 2 ;   ( H ) THE BASIC RULES NECESSARY FOR CHECKING COMPLIANCE WITH ( D ) , ( E ) , ( F ) AND ( G ) .  ARTICLE 4  1 . NOTWITHSTANDING ARTICLE 3 , A MEMBER STATE MAY , WHERE A LIST OF SUBSTANCES HAS BEEN DRAWN UP IN ACCORDANCE WITH ARTICLE 3 ( A ) , AUTHORIZE THE USE WITHIN ITS TERRITORY OF A SUBSTANCE NOT INCLUDED IN THE LIST , SUBJECT TO THE FOLLOWING CONDITIONS :   ( A ) THE AUTHORIZATION MUST BE LIMITED TO A MAXIMUM PERIOD OF THREE YEARS ;   ( B ) THE MEMBER STATES MUST CARRY OUT AN OFFICIAL CHECK OF MATERIALS AND ARTICLES MANUFACTURED FROM A SUBSTANCE OF WHICH IT HAS AUTHORIZED THE USE ;   ( C ) MATERIALS AND ARTICLES THUS MANUFACTURED MUST BEAR A DISTINCTIVE INDICATION WHICH WILL BE DEFINED IN THE AUTHORIZATION .  2 . THE MEMBER STATE SHALL FORWARD TO THE OTHER MEMBER STATES AND TO THE COMMISSION THE TEXT OF ANY AUTHORIZATION DRAWN UP PURSUANT TO PARAGRAPH 1 WITHIN TWO MONTS OF THE DATE OF ITS TAKING EFFECT .  3 . BEFORE THE EXPIRY OF THE THREE-YEAR PERIOD PROVIDED FOR IN PARAGRAPH 1 , THE MEMBER STATE MAY SUBMIT TO THE COMMISSION A REQUEST FOR THE INCLUSION IN THE LIST REFERRED TO IN ARTICLE 3 ( A ) OF THE SUBSTANCE GIVEN NATIONAL AUTHORIZATION IN ACCORDANCE WITH PARAGRAPH 1 . AT THE SAME TIME , IT SHALL SUPPLY SUPPORTING DOCUMENTS SETTING OUT THE GROUNDS ON WHICH IT DEEMS SUCH INCLUSION JUSTIFIED AND SHALL INDICATE THE USES FOR WHICH THIS SUBSTANCE IS INTENDED .  WITHIN 18 MONTHS OF THE SUBMISSION OF THE REQUEST , A DECISION SHALL BE TAKEN ON THE BASIS OF INFORMATION RELATING TO PUBLIC HEALTH , AFTER CONSULTING THE SCIENTIFIC COMMITTEE FOR FOOD AND IN ACCORDANCE WITH THE PROCEDURE LAID DOWN IN ARTICLE 10 AS TO WHETHER THE SUBSTANCE IN QUESTION MAY BE INCLUDED IN THE LIST REFERRED TO IN ARTICLE 3 ( A ) OR WHETHER THE NATIONAL AUTHORIZATION SHOULD BE REVOKED . IF PROVISIONS PROVE NECESSARY PURSUANT TO ARTICLE 3 ( B ) , ( C ) AND ( D ) , THESE SHALL BE ADOPTED IN ACCORDANCE WITH THE SAME PROCEDURE . NOTWITHSTANDING PARAGRAPH 1 ( A ) , THE NATIONAL AUTHORIZATION SHALL REMAIN IN FORCE UNTIL A DECISION IS TAKEN ON THE REQUEST FOR INCLUSION IN THE LIST .  SHOULD IT BE DECIDED PURSUANT TO THE PRECEDING SUBPARAGRAPH THAT THE NATIONAL AUTHORIZATION SHOULD BE REVOKED , THIS DECISION SHALL APPLY TO ANY OTHER NATIONAL AUTHORIZATION IN RESPECT OF THE SUBSTANCE IN QUESTION . THE DECISION MAY STIPULATE THAT THE BAN ON THE USE OF THIS SUBSTANCE SHALL EXTEND TO USES OTHER THAN THOSE REFERRED TO IN THE REQUEST FOR INCLUSION IN THE LIST .  ARTICLE 5  WITHOUT PREJUDICE TO ARTICLE 4 ( 3 ) , AMENDMENTS TO THE ANNEXES OF THE SPECIFIC DIRECTIVES NECESSARY TO TAKE ACCOUNT OF PROGRESS IN SCIENTIFIC AND TECHNICAL KNOWLEDGE SHALL BE ADOPTED , WHERE APPROPRIATE FOLLOWING CONSULTATION OF THE SCIENTIFIC COMMITTEE FOR FOOD , IN ACCORDANCE WITH THE PROCEDURE PROVIDED FOR IN ARTICLE 10 IN SO FAR AS THE SPECIFIC DIRECTIVES PROVIDE FOR THIS PROCEDURE .  ARTICLE 6  1 . WHERE A MEMBER STATE , AS A RESULT OF NEW INFORMATION OR OF A REASSESSMENT OF EXISTING INFORMATION MADE SINCE ONE OF THE SPECIFIC DIRECTIVES WAS ADOPTED , HAS DETAILED GROUNDS FOR ESTABLISHING THAT THE USE OF A MATERIAL OR ARTICLE ENDANGERS HUMAN HEALTH ALTHOUGH IT COMPLIES WITH THE RELEVANT SPECIFIC DIRECTIVE , THAT MEMBER STATE MAY TEMPORARILY SUSPEND OR RESTRICT APPLICATION OF THE PROVISIONS IN QUESTION WITHIN ITS TERRITORY . IT SHALL IMMEDIATELY INFORM THE OTHER MEMBER STATES AND THE COMMISSION THEREOF AND GIVE REASONS FOR ITS DECISION .  2 . THE COMMISSION SHALL EXAMINE AS SOON AS POSSIBLE THE GROUNDS GIVEN BY THE MEMBER STATE CONCERNED AND CONSULT THE MEMBER STATES WITHIN THE STANDING COMMITTEE FOR FOODSTUFFS , AND SHALL THEN DELIVER ITS OPINION FORTHWITH AND TAKE THE APPROPRIATE MEASURES .  3 . IF THE COMMISSION CONSIDERS THAT AMENDMENTS TO THE SPECIFIC DIRECTIVE ARE NECESSARY IN ORDER TO RESOLVE THE DIFFICULTIES MENTIONED IN PARAGRAPH 1 AND TO ENSURE THE PROTECTION OF HUMAN HEALTH , IT SHALL INITIATE THE PROCEDURE LAID DOWN IN ARTICLE 10 , WITH A VIEW TO ADOPTING THESE AMENDMENTS ; THE MEMBER STATE WHICH HAS ADOPTED SAFEGUARD MEASURES MAY IN THAT EVENT RETAIN THEM UNTIL THE AMENDMENTS ENTER INTO FORCE .  ARTICLE 7  1 . WITHOUT PREJUDICE TO ANY EXCEPTIONS PROVIDED FOR IN THE SPECIFIC DIRECTIVES , MATERIALS AND ARTICLES NOT ALREADY IN CONTACT WITH FOODSTUFFS MUST , WHEN PLACED ON THE MARKET , BE ACCOMPANIED BY :   ( A ) _ ONE OR MORE OF THE FOLLOWING PARTICULARS , AS APPROPRIATE :   _ " FOR FOOD USE " ,   _ " POUR CONTACT ALIMENTAIRE " OR " CONVIENT POUR ALIMENTS " ,   _ " TIL LEVNEDSMIDLER " ,   _ " FUER LEBENSMITTEL " ,   _ " PER ALIMENTI " ,   _ " VOOR LEVENSMIDDELEN " OR " VOOR EET _ EN DRINKWAREN " ,   _ " LE HAGHAIDH BIA " ;   _ OR A SPECIFIC INDICATION AS TO THEIR USE , SUCH AS COFFEE-MACHINE , WINE BOTTLE , SOUP SPOON ;   _ OR A SYMBOL , TO BE DETERMINED IN ACCORDANCE WITH THE PROCEDURE LAID DOWN IN ARTICLE 10 ;   ( B ) WHERE APPROPRIATE , ANY SPECIAL CONDITIONS TO BE OBSERVED WHEN THEY ARE BEING USED ;   ( C ) _ EITHER THE NAME OR TRADE NAME AND THE ADDRESS OR REGISTERED OFFICE ,   _ OR THE REGISTERED TRADE MARK OF THE MANUFACTURER OR PROCESSOR , OR OF A SELLER ESTABLISHED WITHIN THE COMMUNITY .  2 . THE PARTICULARS LISTED IN PARAGRAPH 1 MUST BE CLEARLY , LEGIBLY AND INDELIBLY SHOWN :   ( A ) AT THE RETAIL STAGE :   _ ON THE MATERIALS AND ARTICLES OR ON THE PACKAGING ,   _ OR ON LABELS AFFIXED TO THE MATERIALS AND ARTICLES OR TO THEIR PACKAGING ,   _ OR ON A SIGN IN THE IMMEDIATE VICINITY OF THE MATERIALS AND ARTICLES AND CLEARLY VISIBLE TO PURCHASERS ; IN THE CASE MENTIONED IN PARAGRAPH 1 ( C ) , HOWEVER , THE LATTER OPTION SHALL BE OPEN ONLY IF THESE PARTICULARS OR A LABEL BEARING THEM CAN , FOR TECHNICAL REASONS , BE AFFIXED TO THE MATERIALS AND ARTICLES NEITHER AT THE MANUFACTURING NOR AT THE MARKETING STAGE ;   ( B ) AT THE MARKETING STAGES OTHER THAN THE RETAIL STAGE :   _ ON THE ACCOMPANYING DOCUMENTS ,   _ OR ON THE LABELS OR PACKAGING ,   _ OR ON THE MATERIALS AND ARTICLES THEMSELVES .  HOWEVER , MEMBER STATES SHALL HAVE THE OPTION AT THE RETAIL STAGE OF NOT MAKING THE PARTICULARS REFERRED TO IN PARAGRAPH 1 ( A ) COMPULSORY WITHIN THEIR TERRITORY FOR MATERIALS AND ARTICLES WHICH BY THEIR NATURE ARE CLEARLY INTENDED TO COME INTO CONTACT WITH FOODSTUFFS .  3 . THE PARTICULARS PROVIDED FOR IN PARAGRAPH 1 ( A ) AND ( B ) SHALL BE CONFINED TO MATERIALS AND ARTICLES WHICH COMPLY :   ( A ) WITH THE SPECIFIC DIRECTIVES ;   ( B ) IN THE ABSENCE OF SPECIFIC DIRECTIVES , WITH THE CRITERIA LAID DOWN IN ARTICLE 2 AND ANY NATIONAL PROVISIONS .  4 . NOTWITHSTANDING PARAGRAPH 1 , MEMBER STATES SHALL HAVE THE OPTION OF MAKING THESE PARTICULARS COMPULSORY WITHIN THEIR TERRITORY FOR ONLY THOSE MATERIALS AND ARTICLES TO WHICH SPECIFIC DIRECTIVES OR , FAILING THESE , SIMILAR NATIONAL PROVISIONS , APPLY .  5 . IN THE CASE OF MATERIALS AND ARTICLES NOT YET SUBJECT TO A SPECIFIC DIRECTIVE , MEMBER STATES MAY RETAIN THE EXISTING NATIONAL PROVISIONS WHICH REQUIRE THAT SUCH MATERIALS AND ARTICLES BE ACCOMPANIED BY A WRITTEN DECLARATION ATTESTING THAT THEY COMPLY WITH THE RULES APPLYING TO THEM .  6 . HOWEVER , A MEMBER STATE MAY PROHIBIT RETAIL TRADE IN MATERIALS AND ARTICLES WITHIN ITS TERRITORY IF THE PARTICULARS REQUIRED UNDER PARAGRAPH 1 ( A ) AND ( B ) ARE NOT SHOWN ON THE LABELS , PACKAGING , SIGNS OR ACCOMPANYING DOCUMENTS IN AT LEAST ITS NATIONAL OR OFFICIAL LANGUAGE OR LANGUAGES .  MEMBER STATES MAY ALSO PROVIDE THAT THE PARTICULARS REFERRED TO IN PARAGRAPH 1 ( A ) AND ( B ) MUST BE SHOWN BY THE RETAILER IN A LANGUAGE EASILY UNDERSTOOD BY THE PURCHASERS . ONLY A NOTICE PLACED IN THE VICINITY OF THE DISPLAYED GOODS MAY BE REQUIRED FOR THIS PURPOSE .  ARTICLE 8  1 . MEMBER STATES SHALL ADOPT ALL THE MEASURES NECESSARY TO ENSURE THAT TRADE IN AND THE USE OF MATERIALS AND ARTICLES WHICH COMPLY WITH THE RULES LAID DOWN IN THIS DIRECTIVE OR IN THE SPECIFIC DIRECTIVES CANNOT BE IMPEDED BY THE APPLICATION OF NON-HARMONIZED NATIONAL PROVISIONS GOVERNING THE COMPOSITION , BEHAVIOUR IN THE PRESENCE OF FOODSTUFFS OR LABELLING OF THESE MATERIALS AND ARTICLES .  2 . PARAGRAPH 1 SHALL NOT BE APPLICABLE TO NON-HARMONIZED PROVISIONS JUSTIFIED ON GROUNDS OF :   _ PROTECTION OF PUBLIC HEALTH ,   _ PREVENTION OF FRAUDS , UNLESS SUCH PROVISIONS ARE LIABLE TO IMPEDE THE APPLICATION OF THE RULES LAID DOWN BY THIS DIRECTIVE ,   _ PROTECTION OF INDUSTRIAL AND COMMERCIAL PROPERTY , INDICATIONS OF SOURCE OR PREVENTION OF UNFAIR COMPETITION .  ARTICLE 9  UNLESS OTHERWISE PROVIDED IN THE SPECIFIC DIRECTIVES , THE SAMPLING PROCEDURES AND METHODS OF ANALYSIS NECESSARY FOR CHECKING COMPLIANCE WITH ARTICLE 3 ( A ) TO ( G ) SHALL BE DETERMINED IN ACCORDANCE WITH THE PROCEDURE LAID DOWN IN ARTICLE 10 .  ARTICLE 10  1 . WHERE THE PROCEDURE LAID DOWN IN THIS ARTICLE IS TO BE FOLLOWED , THE MATTER SHALL BE REFERRED TO THE STANDING COMMITTEE FOR FOODSTUFFS SET UP BY DECISION 69/414/EEC ( HEREINAFTER REFERRED TO AS " THE COMMITTEE " ) BY ITS CHAIRMAN , EITHER ON HIS OWN INITIATIVE OR AT THE REQUEST OF A REPRESENTATIVE OF A MEMBER STATE .  2 . THE COMMISSION REPRESENTATIVE SHALL SUBMIT TO THE COMMITTEE A DRAFT OF THE MEASURES TO BE TAKEN . THE COMMITTEE SHALL GIVE ITS OPINION ON THIS DRAFT WITHIN A TIME LIMIT SET BY THE CHAIRMAN HAVING REGARD TO THE URGENCY OF THE MATTER . OPINIONS SHALL BE DELIVERED 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 MEASURES ENVISAGED ARE IN ACCORDANCE WITH THE OPINION OF THE COMMITTEE , THE COMMISSION SHALL ADOPT THEM .   ( B ) WHERE 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 ON THE MEASURES TO BE TAKEN . THE COUNCIL SHALL ACT BY A QUALIFIED MAJORITY .   ( C ) IF , WITHIN THREE MONTHS OF THE PROPOSAL HAVING BEEN SUBMITTED TO IT , THE COUNCIL HAS NOT ACTED , THE PROPOSED MEASURES SHALL BE ADOPTED BY THE COMMISSION .  ARTICLE 11  ARTICLE 10 SHALL APPLY FOR A PERIOD OF 18 MONTHS FROM THE DATE ON WHICH THE MATTER WAS FIRST REFERRED TO THE COMMITTEE PURSUANT TO ARTICLE 10 ( 1 ) .  ARTICLE 12  THIS DIRECTIVE SHALL NOT APPLY TO THE MATERIALS AND ARTICLES REFERRED TO IN ARTICLE 1 WHICH ARE INTENDED FOR EXPORT OUTSIDE THE COMMUNITY .  ARTICLE 13  1 . WITHIN 18 MONTHS OF THE NOTIFICATION OF THIS DIRECTIVE , MEMBER STATES SHALL , IF NECESSARY , AMEND THEIR LAWS TO COMPLY WITH THIS DIRECTIVE AND SHALL FORTHWITH INFORM THE COMMISSION THEREOF . THE LAWS THUS AMENDED SHALL BE APPLIED IN SUCH A WAY AS TO :   _ AUTHORIZE , TWO YEARS AFTER NOTIFICATION OF THIS DIRECTIVE , TRADE IN MATERIALS AND ARTICLES COMPLYING WITH THE PROVISIONS LAID DOWN IN THIS DIRECTIVE , WITHOUT PREJUDICE TO THE APPLICATION OF NATIONAL PROVISIONS , WHICH IN THE ABSENCE OF SPECIFIC DIRECTIVES , SHALL APPLY TO CERTAIN GROUPS OF MATERIALS AND ARTICLES ,   _ PROHIBIT , THREE YEARS AFTER NOTIFICATION OF THIS DIRECTIVE , TRADE IN AND USE OF MATERIALS AND ARTICLES WHICH DO NOT COMPLY WITH THE PROVISIONS LAID DOWN IN THIS DIRECTIVE .  2 . NOTWITHSTANDING PARAGRAPH 1 , MEMBER STATES MAY PROHIBIT THE MANUFACTURE OF MATERIALS AND ARTICLES NOT COMPLYING WITH THIS DIRECTIVE TWO YEARS AFTER ITS NOTIFICATION .  ARTICLE 14  THIS DIRECTIVE SHALL ALSO APPLY IN THE FRENCH OVERSEAS DEPARTMENTS .  ARTICLE 15  THIS DIRECTIVE IS ADDRESSED TO THE MEMBER STATES .  DONE AT BRUSSELS , 23 NOVEMBER 1976 .  FOR THE COUNCIL  THE PRESIDENT  A . P . L . M . M . VAN DER STEE