Avis juridique important

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31983L0648

Fifteenth Council Directive 83/648/EEC of 19 December 1983 on the harmonization of the laws of the Member States relating to turnover taxes - deferment of the introduction of the common system of value added tax in the Hellenic Republic

Official Journal L 360 , 23/12/1983 P. 0049 - 0049 Finnish special edition: Chapter 9 Volume 1 P. 0121  Spanish special edition: Chapter 09 Volume 1 P. 0165  Swedish special edition: Chapter 9 Volume 1 P. 0121  Portuguese special edition Chapter 09 Volume 1 P. 0165

*****FIFTEENTH  COUNCIL DIRECTIVE  of 19 December 1983  on the harmonization of the laws of the Member States relating to turnover taxes - deferment of the introduction of the common system of value added tax in the Hellenic Republic  (83/648/EEC)  THE COUNCIL OF THE EUROPEAN  COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 99 and 100 thereof,  Having regard to the proposal from the Commission,  Having regard to the opinion of the European Parliament (1),  Having regard to the opinion of the Economic and Social Committee (2),  Whereas the Greek Government informed the Commission on 19 July 1983 that, for technical and economic reasons, it would be unable to introduce the common system of value added tax by 1 January 1984, the date set by Article 145 in conjunction with Annex XII of the 1979 Act of Accession; whereas the Greek Government consequently requests that the introduction of value added tax be deferred for two years;  Whereas the present Greek tax system is such that the Greek Government's request should be complied with for the technical reasons it has given,  HAS ADOPTED THIS DIRECTIVE:  Article 1  At the earliest opportunity, and by 1 January 1986 at the latest, the Hellenic Republic shall put into effect the measures necessary to comply with Directives 67/227/EEC (3), 67/228/EEC (4), 77/388/EEC (5) and any other Directive, adopted or to be adopted, relating to the common system of value added tax.  Article 2  The Commission shall, by 31 December 1984, present the Council and the European Parliament with a report on the progress made by the Hellenic Republic in respect of the work of putting into effect the Directives referred to in Article 1.  Article 3  This Directive is addressed to the Hellenic Republic.  Done at Brussels, 19 December 1983.  For the Council  The President  G. VARFIS  (1) Opinion delivered on 16 December 1983 (not yet published in the Official Journal).  (2) Opinion delivered on 15 December 1983 (not yet published in the Official Journal).  (3) OJ No 71, 14. 4. 1967, p. 1301/67.  (4) OJ No 71, 14. 4. 1967, p. 1303/67.  (5) OJ No L 145, 13. 6. 1977, p. 1.


Avis juridique important

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32003L0008

Council Directive 2002/8/EC of 27 January 2003 to improve access to justice in cross-border disputes by establishing minimum common rules relating to legal aid for such disputes

Official Journal L 026 , 31/01/2003 P. 0041 - 0047

Council Directive 2002/8/ECof 27 January 2003to improve access to justice in cross-border disputes by establishing minimum common rules relating to legal aid for such disputesTHE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Articles 61(c) and 67 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:(1) The European Union has set itself the objective of maintaining and developing an area of freedom, security and justice in which the free movement of persons is ensured. For the gradual establishment of such an area, the Community is to adopt, among others, the measures relating to judicial cooperation in civil matters having cross-border implications and needed for the proper functioning of the internal market.(2) According to Article 65(c) of the Treaty, these measures are to include measures eliminating obstacles to the good functioning of civil proceedings, if necessary by promoting the compatibility of the rules on civil procedure applicable in the Member States.(3) The Tampere European Council on 15 and 16 October 1999 called on the Council to establish minimum standards ensuring an adequate level of legal aid in cross-border cases throughout the Union.(4) All Member States are contracting parties to the European Convention for the Protection of Human Rights and Fundamental Freedom of 4 November 1950. The matters referred to in this Directive shall be dealt with in compliance with that Convention and in particular the respect of the principle of equality of both parties in a dispute.(5) This Directive seeks to promote the application of legal aid in cross-border disputes for persons who lack sufficient resources where aid is necessary to secure effective access to justice. The generally recognised right to access to justice is also reaffirmed by Article 47 of the Charter of Fundamental Rights of the European Union.(6) Neither the lack of resources of a litigant, whether acting as claimant or as defendant, nor the difficulties flowing from a dispute's cross-border dimension should be allowed to hamper effective access to justice.(7) Since the objectives of this Directive cannot be sufficiently achieved by the Member States acting alone and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives.(8) The main purpose of this Directive is to guarantee an adequate level of legal aid in cross-border disputes by laying down certain minimum common standards relating to legal aid in such disputes. A Council directive is the most suitable legislative instrument for this purpose.(9) This Directive applies in cross-border disputes, to civil and commercial matters.(10) All persons involved in a civil or commercial dispute within the scope of this Directive must be able to assert their rights in the courts even if their personal financial situation makes it impossible for them to bear the costs of the proceedings. Legal aid is regarded as appropriate when it allows the recipient effective access to justice under the conditions laid down in this Directive.(11) Legal aid should cover pre-litigation advice with a view to reaching a settlement prior to bringing legal proceedings, legal assistance in bringing a case before a court and representation in court and assistance with or exemption from the cost of proceedings.(12) It shall be left to the law of the Member State in which the court is sitting or where enforcement is sought whether the costs of proceedings may include the costs of the opponent imposed on the recipient of legal aid.(13) All Union citizens, wherever they are domiciled or habitually resident in the territory of a Member State, must be eligible for legal aid in cross-border disputes if they meet the conditions provided for by this Directive. The same applies to third-country nationals who habitually and lawfully reside in a Member State.(14) Member States should be left free to define the threshold above which a person would be presumed able to bear the costs of proceedings, in the conditions defined in this Directive. Such thresholds are to be defined in the light of various objective factors such as income, capital or family situation.(15) The objective of this Directive could not, however, be attained if legal aid applicants did not have the possibility of proving that they cannot bear the costs of proceedings even if their resources exceed the threshold defined by the Member State where the court is sitting. When making the assessment of whether legal aid is to be granted on this basis, the authorities in the Member State where the court is sitting may take into account information as to the fact that the applicant satisfies criteria in respect of financial eligibility in the Member State of domicile or habitual residence.(16) The possibility in the instant case of resorting to other mechanisms to ensure effective access to justice is not a form of legal aid. But it can warrant a presumption that the person concerned can bear the costs of the procedure despite his/her unfavourable financial situation.(17) Member States should be allowed to reject applications for legal aid in respect of manifestly unfounded actions or on grounds related to the merits of the case in so far as pre-litigation advice is offered and access to justice is guaranteed. When taking a decision on the merits of an application, Member States may reject legal aid applications when the applicant is claiming damage to his or her reputation, but has suffered no material or financial loss or the application concerns a claim arising directly out of the applicant's trade or self-employed profession.(18) The complexity of and differences between the legal systems of the Member States and the costs inherent in the cross-border dimension of a dispute should not preclude access to justice. Legal aid should accordingly cover costs directly connected with the cross-border dimension of a dispute.(19) When considering if the physical presence of a person in court is required, the courts of a Member State should take into consideration the full advantage of the possibilities offered by Council Regulation (EC) No 1206/2001 of 28 May 2001 on cooperation between the courts of the Member States in the taking of evidence in civil or commercial matters(4).(20) If legal aid is granted, it must cover the entire proceeding, including expenses incurred in having a judgment enforced; the recipient should continue receiving this aid if an appeal is brought either against or by the recipient in so far as the conditions relating to the financial resources and the substance of the dispute remain fulfilled.(21) Legal aid is to be granted on the same terms both for conventional legal proceedings and for out-of-court procedures such as mediation, where recourse to them is required by the law, or ordered by the court.(22) Legal aid should also be granted for the enforcement of authentic instruments in another Member State under the conditions defined in this Directive.(23) Since legal aid is given by the Member State in which the court is sitting or where enforcement is sought, except pre-litigation assistance if the legal aid applicant is not domiciled or habitually resident in the Member State where the court is sitting, that Member State must apply its own legislation, in compliance with the principles of this Directive.(24) It is appropriate that legal aid is granted or refused by the competent authority of the Member State in which the court is sitting or where a judgment is to be enforced. This is the case both when that court is trying the case in substance and when it first has to decide whether it has jurisdiction.(25) Judicial cooperation in civil matters should be organised between Member States to encourage information for the public and professional circles and to simplify and accelerate the transmission of legal aid applications between Member States.(26) The notification and transmission mechanisms provided for by this Directive are inspired directly by those of the European Agreement on the transmission of applications for legal aid, signed in Strasbourg on 27 January 1977, hereinafter referred to as "1977 Agreement". A time limit, not provided for by the 1977 Agreement, is set for the transmission of legal aid applications. A relatively short time limit contributes to the smooth operation of justice.(27) The information transmitted pursuant to this Directive should enjoy protection. Since Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data(5), and Directive 97/66/EC of the European Parliament and of the Council of 15 December 1997 concerning the processing of personal data and the protection of privacy in the telecommunications sector(6), are applicable, there is no need for specific provisions on data protection in this Directive.(28) The establishment of a standard form for legal aid applications and for the transmission of legal aid applications in the event of cross-border litigation will make the procedures easier and faster.(29) Moreover, these application forms, as well as national application forms, should be made available on a European level through the information system of the European Judicial Network, established in accordance with Decision 2001/470/EC(7).(30) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(8).(31) It should be specified that the establishment of minimum standards in cross-border disputes does not prevent Member States from making provision for more favourable arrangements for legal aid applicants and recipients.(32) The 1977 Agreement and the additional Protocol to the European Agreement on the transmission of applications for legal aid, signed in Moscow in 2001, remain applicable to relations between Member States and third countries that are parties to the 1977 Agreement or the Protocol. But this Directive takes precedence over provisions contained in the 1977 Agreement and the Protocol in relations between Member States.(33) The United Kingdom and Ireland have given notice of their wish to participate in the adoption of this Directive in accordance with Article 3 of the Protocol on the position of the United Kingdom and Ireland annexed to the Treaty on European Union and to the Treaty establishing the European Community.(34) In accordance with Articles 1 and 2 of the Protocol on the position of Denmark annexed to the Treaty on European Union and to the Treaty establishing the European Community, Denmark is not taking part in the adoption of this Directive and is not bound by it or subject to its application,HAS ADOPTED THIS DIRECTIVE:CHAPTER ISCOPE AND DEFINITIONSArticle 1Aims and scope1. The purpose of this Directive is to improve access to justice in cross-border disputes by establishing minimum common rules relating to legal aid in such disputes.2. It shall apply, in cross-border disputes, to civil and commercial matters whatever the nature of the court or tribunal. It shall not extend, in particular, to revenue, customs or administrative matters.3. In this Directive, "Member State" shall mean Member States with the exception of Denmark.Article 2Cross-border disputes1. For the purposes of this Directive, a cross-border dispute is one where the party applying for legal aid in the context of this Directive is domiciled or habitually resident in a Member State other than the Member State where the court is sitting or where the decision is to be enforced.2. The Member State in which a party is domiciled shall be determined in accordance with Article 59 of Council Regulation (EC) No 44/2001 of 22 December 2000 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters(9).3. The relevant moment to determine if there is a cross-border dispute is the time when the application is submitted, in accordance with this Directive.CHAPTER IIRIGHT TO LEGAL AIDArticle 3Right to legal aid1. Natural persons involved in a dispute covered by this Directive shall be entitled to receive appropriate legal aid in order to ensure their effective access to justice in accordance with the conditions laid down in this Directive.2. Legal aid is considered to be appropriate when it guarantees:(a) pre-litigation advice with a view to reaching a settlement prior to bringing legal proceedings;(b) legal assistance and representation in court, and exemption from, or assistance with, the cost of proceedings of the recipient, including the costs referred to in Article 7 and the fees to persons mandated by the court to perform acts during the proceedings.In Member States in which a losing party is liable for the costs of the opposing party, if the recipient loses the case, the legal aid shall cover the costs incurred by the opposing party, if it would have covered such costs had the recipient been domiciled or habitually resident in the Member State in which the court is sitting.3. Member States need not provide legal assistance or representation in the courts or tribunals in proceedings especially designed to enable litigants to make their case in person, except when the courts or any other competent authority otherwise decide in order to ensure equality of parties or in view of the complexity of the case.4. Member States may request that legal aid recipients pay reasonable contributions towards the costs of proceedings taking into account the conditions referred to in Article 5.5. Member States may provide that the competent authority may decide that recipients of legal aid must refund it in whole or in part if their financial situation has substantially improved or if the decision to grant legal aid had been taken on the basis of inaccurate information given by the recipient.Article 4Non-discriminationMember States shall grant legal aid without discrimination to Union citizens and third-country nationals residing lawfully in a Member State.CHAPTER IIICONDITIONS AND EXTENT OF LEGAL AIDArticle 5Conditions relating to financial resources1. Member States shall grant legal aid to persons referred to in Article 3(1) who are partly or totally unable to meet the costs of proceedings referred to in Article 3(2) as a result of their economic situation, in order to ensure their effective access to justice.2. The economic situation of a person shall be assessed by the competent authority of the Member State in which the court is sitting, in the light of various objective factors such as income, capital or family situation, including an assessment of the resources of persons who are financially dependant on the applicant.3. Member States may define thresholds above which legal aid applicants are deemed partly or totally able to bear the costs of proceedings set out in Article 3(2). These thresholds shall be defined on the basis of the criteria defined in paragraph 2 of this Article.4. Thresholds defined according to paragraph 3 of this Article may not prevent legal aid applicants who are above the thresholds from being granted legal aid if they prove that they are unable to pay the cost of the proceedings referred to in Article 3(2) as a result of differences in the cost of living between the Member States of domicile or habitual residence and of the forum.5. Legal aid does not need to be granted to applicants in so far as they enjoy, in the instant case, effective access to other mechanisms that cover the cost of proceedings referred to in Article 3(2).Article 6Conditions relating to the substance of disputes1. Member States may provide that legal aid applications for actions which appear to be manifestly unfounded may be rejected by the competent authorities.2. If pre-litigation advice is offered, the benefit of further legal aid may be refused or cancelled on grounds related to the merits of the case in so far as access to justice is guaranteed.3. When taking a decision on the merits of an application and without prejudice to Article 5, Member States shall consider the importance of the individual case to the applicant but may also take into account the nature of the case when the applicant is claiming damage to his or her reputation but has suffered no material or financial loss or when the application concerns a claim arising directly out of the applicant's trade or self-employed profession.Article 7Costs related to the cross-border nature of the disputeLegal aid granted in the Member State in which the court is sitting shall cover the following costs directly related to the cross-border nature of the dispute:(a) interpretation;(b) translation of the documents required by the court or by the competent authority and presented by the recipient which are necessary for the resolution of the case; and(c) travel costs to be borne by the applicant where the physical presence of the persons concerned with the presentation of the applicant's case is required in court by the law or by the court of that Member State and the court decides that the persons concerned cannot be heard to the satisfaction of the court by any other means.Article 8Costs covered by the Member State of the domicile or habitual residenceThe Member State in which the legal aid applicant is domiciled or habitually resident shall provide legal aid, as referred to in Article 3(2), necessary to cover:(a) costs relating to the assistance of a local lawyer or any other person entitled by the law to give legal advice, incurred in that Member State until the application for legal aid has been received, in accordance with this Directive, in the Member State where the court is sitting;(b) the translation of the application and of the necessary supporting documents when the application is submitted to the authorities in that Member State.Article 9Continuity of legal aid1. Legal aid shall continue to be granted totally or partially to recipients to cover expenses incurred in having a judgment enforced in the Member State where the court is sitting.2. A recipient who in the Member State where the court is sitting has received legal aid shall receive legal aid provided for by the law of the Member State where recognition or enforcement is sought.3. Legal aid shall continue to be available if an appeal is brought either against or by the recipient, subject to Articles 5 and 6.4. Member States may make provision for the re-examination of the application at any stage in the proceedings on the grounds set out in Articles 3(3) and (5), 5 and 6, including proceedings referred to in paragraphs 1 to 3 of this Article.Article 10Extrajudicial proceduresLegal aid shall also be extended to extrajudicial procedures, under the conditions defined in this Directive, if the law requires the parties to use them, or if the parties to the dispute are ordered by the court to have recourse to them.Article 11Authentic instrumentsLegal aid shall be granted for the enforcement of authentic instruments in another Member State under the conditions defined in this Directive.CHAPTER IVPROCEDUREArticle 12Authority granting legal aidLegal aid shall be granted or refused by the competent authority of the Member State in which the court is sitting, without prejudice to Article 8.Article 13Introduction and transmission of legal aid applications1. Legal aid applications may be submitted to either:(a) the competent authority of the Member State in which the applicant is domiciled or habitually resident (transmitting authority); or(b) the competent authority of the Member State in which the court is sitting or where the decision is to be enforced (receiving authority).2. Legal aid applications shall be completed in, and supporting documents translated into:(a) the official language or one of the languages of the Member State of the competent receiving authority which corresponds to one of the languages of the Community institutions; or(b) another language which that Member State has indicated it can accept in accordance with Article 14(3).3. The competent transmitting authorities may decide to refuse to transmit an application if it is manifestly:(a) unfounded; or(b) outside the scope of this Directive.The conditions referred to in Article 15(2) and (3) apply to such decisions.4. The competent transmitting authority shall assist the applicant in ensuring that the application is accompanied by all the supporting documents known by it to be required to enable the application to be determined. It shall also assist the applicant in providing any necessary translation of the supporting documents, in accordance with Article 8(b).The competent transmitting authority shall transmit the application to the competent receiving authority in the other Member State within 15 days of the receipt of the application duly completed in one of the languages referred to in paragraph 2, and the supporting documents, translated, where necessary, into one of those languages.5. Documents transmitted under this Directive shall be exempt from legalisation or any equivalent formality.6. The Member States may not charge for services rendered in accordance with paragraph 4. Member States in which the legal aid applicant is domiciled or habitually resident may lay down that the applicant must repay the costs of translation borne by the competent transmitting authority if the application for legal aid is rejected by the competent authority.Article 14Competent authorities and language1. Member States shall designate the authority or authorities competent to send (transmitting authorities) and receive (receiving authorities) the application.2. Each Member State shall provide the Commission with the following information:- the names and addresses of the competent receiving or transmitting authorities referred to in paragraph 1,- the geographical areas in which they have jurisdiction,- the means by which they are available to receive applications, and- the languages that may be used for the completion of the application.3. Member States shall notify the Commission of the official language or languages of the Community institutions other than their own which is or are acceptable to the competent receiving authority for completion of the legal aid applications to be received, in accordance with this Directive.4. Member States shall communicate to the Commission the information referred to in paragraphs 2 and 3 before 30 November 2004. Any subsequent modification of such information shall be notified to the Commission no later than two months before the modification enters into force in that Member State.5. The information referred to in paragraphs 2 and 3 shall be published in the Official Journal of the European Communities.Article 15Processing of applications1. The national authorities empowered to rule on legal aid applications shall ensure that the applicant is fully informed of the processing of the application.2. Where applications are totally or partially rejected, the reasons for rejection shall be given.3. Member States shall make provision for review of or appeals against decisions rejecting legal aid applications. Member States may exempt cases where the request for legal aid is rejected by a court or tribunal against whose decision on the subject of the case there is no judicial remedy under national law or by a court of appeal.4. When the appeals against a decision refusing or cancelling legal aid by virtue of Article 6 are of an administrative nature, they shall always be ultimately subject to judicial review.Article 16Standard form1. To facilitate transmission, a standard form for legal aid applications and for the transmission of such applications shall be established in accordance with the procedure set out in Article 17(2).2. The standard form for the transmission of legal aid applications shall be established at the latest by 30 May 2003.The standard form for legal aid applications shall be established at the latest by 30 November 2004.CHAPTER VFINAL PROVISIONSArticle 17Committee1. The Commission shall be assisted by a Committee.2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply.3. The Committee shall adopt its Rules of Procedure.Article 18InformationThe competent national authorities shall cooperate to provide the general public and professional circles with information on the various systems of legal aid, in particular via the European Judicial Network, established in accordance with Decision 2001/470/EC.Article 19More favourable provisionsThis Directive shall not prevent the Member States from making provision for more favourable arrangements for legal aid applicants and recipients.Article 20Relation with other instrumentsThis Directive shall, as between the Member States, and in relation to matters to which it applies, take precedence over provisions contained in bilateral and multilateral agreements concluded by Member States including:(a) the European Agreement on the transmission of applications for legal aid, signed in Strasbourg on 27 January 1977, as amended by the additional Protocol to the European Agreement on the transmission of applications for legal aid, signed in Moscow in 2001;(b) the Hague Convention of 25 October 1980 on International Access to Justice.Article 21Transposition into national law1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 30 November 2004 with the exception of Article 3(2)(a) where the transposition of this Directive into national law shall take place no later than 30 May 2006. They shall forthwith inform the Commission thereof.When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by Member States.2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.Article 22Entry into forceThis Directive shall enter into force on the date of its publication in the Official Journal of the European Communities.Article 23AddresseesThis Directive is addressed to the Member States in accordance with the Treaty establishing the European Community.Done at Brussels, 27 January 2003.For the CouncilThe PresidentG. Papandreou(1) OJ C 103 E, 30.4.2002, p. 368.(2) Opinion delivered on 25 September 2002 (not yet published in the Official Journal).(3) OJ C 221, 17.9.2002, p. 64.(4) OJ L 174, 27.6.2001, p. 1.(5) OJ L 281, 23.11.1995, p. 31.(6) OJ L 24, 30.1.1998, p. 1.(7) OJ L 174, 27.6.2001, p. 25.(8) OJ L 184, 17.7.1999, p. 23.(9) OJ L 12, 16.1.2001, p. 1; Regulation as amended by Commission Regulation (EC) No 1496/2002 (OJ L 225, 22.8.2002, p. 13).


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32002L0072

Commission Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs (Text with EEA relevance)

Official Journal L 220 , 15/08/2002 P. 0018 - 0058

Commission Directive 2002/72/ECof 6 August 2002relating to plastic materials and articles intended to come into contact with foodstuffs(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs(1), and in particular Article 3 thereof,After consulting the Scientific Committee on Food,Whereas:(1) Commission Directive 90/128/EEC of 23 February 1990 relating to plastic materials and articles intended to come into contact with foodstuffs(2), as last amended by Directive 2002/17/EC(3), has been frequently and substantially amended; for reasons of clarity and rationality, it should therefore be consolidated.(2) Article 2 of Directive 89/109/EEC lays down that materials and articles, in their finished state, must not transfer their constituents to foodstuffs in quantities which could endanger human health or bring about an unacceptable change in the composition of the foodstuffs.(3) In order to achieve this objective in the case of plastic materials and articles, a suitable instrument is a specific Directive within the meaning of Article 3 of Directive 89/109/EEC, the general provisions of which are also applicable to the case in question.(4) The scope of this Directive must coincide with that of Council Directive 82/711/EEC(4).(5) Since the rules established in this Directive are not suitable for ion-exchange resins, these materials and articles will be covered by a subsequent specific Directive.(6) Silicones should be regarded as elastomeric materials rather than plastic materials and therefore should be excluded from the definition of plastic.(7) The establishment of a list of approved substances accompanied by a limit on overall migration and, where necessary, by other specific restrictions will be sufficient to achieve the objective laid down in Article 2 of Directive 89/109/EEC.(8) Besides the monomers and other starting substances fully evaluated and authorised at Community level, there are also monomers and starting substances evaluated and authorised in at least one Member State which may continue to be used pending their evaluation by the Scientific Committee on Food and the decision on their inclusion in the Community list; this Directive will accordingly be extended in due course to the substances and sectors provisionally excluded.(9) The current list of additives is an incomplete list inasmuch as it does not contain all the substances which are currently accepted in one or more Member States; accordingly, these substances continue to be regulated by national laws pending a decision on inclusion in the Community list.(10) This Directive establishes specifications for only a few substances. The other substances, which may require specifications, therefore remain regulated in this respect by national laws pending a decision at Community level.(11) For certain additives the restrictions established in this Directive cannot yet be applied in all situations pending the collection and evaluation of all the data needed for a better estimation of the exposure of the consumer in some specific situations; therefore, these additives appear in a list other than that of the additives fully regulated at Community level.(12) Directive 82/711/EEC lays down the basic rules necessary for testing migration of the constituents of plastic materials and articles and Council Directive 85/572/EEC(5) establishes the list of simulants to be used in the migration tests.(13) The determination of a quantity of a substance in a finished material or article is simpler than the determination of its specific migration level. The verification of compliance through the determination of quantity rather than specific migration level should therefore be permitted under certain conditions.(14) For certain types of plastics the availability of generally recognised diffusion models based on experimental data allows the estimation of the migration level of a substance under certain conditions, therefore avoiding complex, costly and time-consuming testing.(15) The overall migration limit is a measure of the inertness of the material and prevents an unacceptable change in the composition of the foodstuffs, and, moreover, reduces the need for a large number of specific migration limits or other restrictions, thus giving effective control.(16) Council Directive 78/142/EEC(6) lays down limits for the quantity of vinyl chloride present in plastic materials and articles prepared with this substance and for the quantity of vinyl chloride released by these materials and articles, and Commission Directives 80/766/EEC(7) and 81/432/EEC(8) establish the Community methods of analysis for controlling these limits.(17) In view of potential liability, there is a need for the written declaration provided for in Article 6(5) of Directive 89/109/EEC whenever professional use is made of plastic materials and articles which are not by their nature clearly intended for food use.(18) Commission Directive 80/590/EEC(9) determines the symbol that may accompany any material and article intended to come into contact with foodstuffs.(19) In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objective of ensuring the free movement of plastic materials and articles intended to come into contact with foodstuffs, to lay down rules on the definition of plastics and permitted substances. This Directive confines itself to what is necessary in order to achieve the objectives pursued in accordance with the third paragraph of Article 5 of the Treaty.(20) In accordance with Article 3 of Directive 89/109/EEC, the Scientific Committee on Food has been consulted on the provisions liable to affect public health.(21) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health.(22) This Directive should be without prejudice to the deadlines set out in Annex VII, Part B within which the Member States are to comply with Directive 90/128/EEC, and the acts amending it,HAS ADOPTED THIS DIRECTIVE:Article 11. This Directive is a specific Directive within the meaning of Article 3 of Directive 89/109/EEC.2. This Directive shall apply to plastic materials and articles and parts thereof:(a) consisting exclusively of plastics; or(b) composed of two or more layers of materials, each consisting exclusively of plastics, which are bound together by means of adhesives or by any other means,which, in the finished product state, are intended to come into contact or are brought into contact with foodstuffs are intended for that purpose.3. For the purposes of this Directive, "plastics" shall mean the organic macromolecular compounds obtained by polymerisation, polycondensation, polyaddition or any other similar process from molecules with a lower molecular weight or by chemical alteration of natural macromolecules. Other substances or matter may be added to such macromolecular compounds.However, the following shall not be regarded as "plastics":(a) varnished or unvarnished regenerated cellulose film, covered by Commission Directive 93/10/EEC(10);(b) elastomers and natural and synthetic rubber;(c) paper and paperboard, whether modified or not by the addition of plastics;(d) surface coatings obtained from:- paraffin waxes, including synthetic paraffin waxes, and/or micro-crystalline waxes,- mixtures of the waxes listed in the first indent with each other and/or with plastics,(e) ion-exchange resins;(f) silicones.4. This Directive shall not apply, until further action by the Commission, to materials and articles composed of two or more layers, one or more of which does not consist exclusively of plastics, even if the one intended to come into direct contact with foodstuffs does consist exclusively of plastics.Article 2Plastic materials and articles shall not transfer their constituents to foodstuffs in quantities exceeding 10 milligrams per square decimetre of surface area of material or article (mg/dm2) (overall migration limit). However, this limit shall be 60 milligrams of the constituents released per kilogram of foodstuff (mg/kg) in the following cases:(a) articles which are containers or are comparable to containers or which can be filled, with a capacity of not less than 500 millilitres (ml) and not more than 10 litres (l);(b) articles which can be filled and for which it is impracticable to estimate the surface area in contact with foodstuffs;(c) caps, gaskets, stoppers or similar devices for sealing.Article 31. Only those monomers and other starting substances listed in Annex II, Sections A and B, may be used for the manufacture of plastic materials and articles subject to the restrictions specified.2. By way of derogation from the first paragraph the monomers and other starting substances listed in Annex II, Section B, may continue to be used until 31 December 2004 at latest, pending their evaluation by the Scientific Committee on Food.3. The list in Annex II, Section A, may be amended:- either by adding substances listed in Annex II, Section B, according to the criteria in Annex II of Directive 89/109/EEC, or- by including "new substances", i.e. substances which are listed neither in Section A nor in Section B of Annex II, according to Article 3 of Directive 89/109/EEC.4. No Member State shall authorise any new substance for use within its territory except under the procedure in Article 4 of Directive 89/109/EEC.5. The lists appearing in Annex II, Sections A and B, do not yet include monomers and other starting substances used only in the manufacture of:- surface coatings obtained from resinous or polymerised products in liquid, powder or dispersion form, such as varnishes, lacquers, paints, etc.,- epoxy resins,- adhesives and adhesion promoters,- printing inks.Article 4An incomplete list of additives, which may be used for the manufacture of plastic materials and articles, together with the restrictions and/or specifications on their use, is set out in Annex III, Sections A and B.For the substances in Annex III, Section B, the specific migration limits are applied as from 1 January 2004 when the verification of compliance is carried out in simulant D or in test media of substitute tests as laid down in Directives 82/711/EEC and 85/572/EEC.Article 5Only the products obtained by means of bacterial fermentation listed in Annex IV may be used in contact with foodstuffs.Article 61. General specifications related to plastic materials and articles are laid down in Annex V, Part A. Other specifications related to some substances appearing in Annexes II, III and IV are laid down in Annex V, Part B.2. The meaning of the numbers between brackets appearing in the column "Restrictions and/or specifications" is explained in Annex VI.Article 7The specific migration limits in the list set out in Annex II are expressed in mg/kg. However, such limits are expressed in mg/dm2 in the following cases:(a) articles which are containers or are comparable to containers or which can be filled, with a capacity of less than 500 ml or more than 10 l;(b) sheet, film or other materials which cannot be filled of for which it is impracticable to estimate the relationship between the surface area of such materials and the quantity of foodstuffs in contact therewith.In these cases, the limits set out in Annex II, expressed in mg/kg shall be divided by the conventional conversion factor of 6 in order to express them in mg/dm2.Article 81. Verification of compliance with the migration limits shall be carried out in accordance with the rules laid down in Directives 82/711/EEC and 85/572/EEC and the further provisions set out in Annex I.2. The verification of compliance with the specific migration limits provided for in paragraph 1 shall not be compulsory, if it can be established that compliance with the overall migration limit laid down in Article 2 implies that the specific migration limits are not exceeded.3. The verification of compliance with the specific migration limits provided for in paragraph 1 shall not be compulsory, if it can be established that, by assuming complete migration of the residual substance in the material or article, it cannot exceed the specific limit of migration.4. The verification of compliance with the specific migration limits provided for in paragraph 1 may be ensured by the determination of the quantity of a substance in the finished material or article provided that a relationship between that quantity and the value of the specific migration of the substance has been established either by an adequate experimentation or by the application of generally recognised diffusion models based on scientific evidence. To demonstrate the non-compliance of a material or article, confirmation of the estimated migration value by experimental testing is obligatory.Article 91. At the marketing stages other than the retail stages, the plastic materials and articles which are intended to be placed in contact with foodstuffs shall be accompanied by a written declaration in accordance with Article 6(5) of Directive 89/109/EEC.2. Paragraph 1 does not apply to plastic materials and articles, which by their nature are clearly intended to come into contact with foodstuffs.Article 101. Directive 90/128/EEC, as amended by the Directives set out in Annex VII, Part A, is hereby repealed without prejudice to the obligations of the Member States in respect of the deadlines for transposition and application laid down in Annex VII, Part B.2. References to the repealed Directives shall be construed as references to this Directive and be read in accordance with the correlation table set out in Annex VIII.Article 11This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.Article 12This Directive is addressed to the Member States.Done at Brussels, 6 August 2002.For the CommissionDavid ByrneMember of the Commission(1) OJ L 40, 11.2.1989, p. 38.(2) OJ L 75, 21.3.1990, corrected by OJ L 349, 13.12.1990, p. 26.(3) OJ L 58, 28.2.2002, p. 19.(4) OJ L 297, 23.10.1982, p. 26. Directive as last amended by Directive 97/48/EC (OJ L 222, 12.8.1997, p. 10).(5) OJ L 372, 31.12.1985, p. 14.(6) OJ L 44, 15.2.1978, p. 15.(7) OJ L 213, 16.8.1980, p. 42.(8) OJ L 167, 24.6.1981, p. 6.(9) OJ L 151, 19.6.1980, p. 21.(10) OJ L 93, 17.4.1993, p. 27. Directive amended by Directive 93/111/EC (OJ L 310, 14.12.1993, p. 41).ANNEX IFURTHER PROVISIONS APPLICABLE WHEN CHECKING COMPLIANCE WITH THE MIGRATION LIMITSGeneral provisions1. When comparing the results of the migration tests specified in the Annex to Directive 82/711/EEC, the specific gravity of all the simulants should conventionally be assumed to 1. Milligrams of substance(s) released per litre of simulant (mg/l) will thus correspond numerically to milligrams of substance(s) released per kilogram of simulant and, taking into account the provisions laid down in Directive 85/572/EEC, to milligrams of substance(s) released per kilogram of foodstuff.2. Where the migration tests are carried out on samples taken from the material or article or on samples manufactured for the purpose, and the quantities of foodstuff or simulant placed in contact with the sample differ from those employed in the actual conditions under which the material or article is used, the results obtained should be corrected by applying the following formula:>PIC FILE= "L_2002220EN.002202.TIF">>TABLE>3. The determination of migration is carried out on the material or article or, if that is impracticable, using either specimens taken from the material or article or, where appropriate, specimens representative of this material or article.The sample shall be placed in contact with the foodstuff or simulant in a manner representing the contact conditions in actual use. For this purpose, the test shall be performed in such a way that only those parts of the sample intended to come into contact with foodstuffs in actual use will be in contact with the foodstuff or simulant. This condition is particularly important in the case of materials and articles comprising several layers, for closures, etc.The migration testing of caps, gaskets, stoppers or similar devices for sealing must be carried out on these articles by applying them to the containers for which they are intended in a manner which corresponds to the conditions of closing in normal or foreseeable use.It shall in all cases be permissible to demonstrate compliance with migration limits by the use of a more severe test.4. In accordance with the provisions set out in Article 8 of the present Directive, the sample of the material or article is placed in contact with the foodstuff or appropriate simulant for a period and at a temperature which are chosen by reference to the contact conditions in actual use, in accordance with the rules laid down in Directives 82/711/EEC and 85/572/EEC. At the end of the prescribed time, the analytical determination of the total quantity of substances (overall migration) and/or the specific quantity of one or more substances (specific migration) released by the sample is carried out on the foodstuff or simulant.5. Where a material or article is intended to come into repeated contact with foodstuffs, the migration test(s) shall be carried out three times on a single sample in accordance with the conditions laid down in Directive 82/711/EEC using another sample of the food or simulant(s) on each occasion. Its compliance shall be checked on the basis of the level of the migration found in the third test. However, if there is conclusive proof that the level of the migration does not increase in the second and third tests and if the migration limit(s) is (are) not exceeded on the first test, no further test is necessary.Special provisions relating to overall migration6. If the aqueous simulants specified in Directives 82/711/EEC and 85/572/EEC are used, the analytical determination of the total quantity of substances released by the sample may be carried out by evaporation of the simulant and weighing of the residue.If rectified olive oil or any of its substitutes is used, the procedure given below may be followed.The sample of the material or article is weighed before and after contact with the simulant. The simulant absorbed by the sample is extracted and determined quantitatively. The quantity of simulant found is subtracted from the weight of the sample measured after contact with the simulant. The difference between the initial and corrected final weights represents the overall migration of the sample examined.Where a material or article is intended to come into repeated contact with foodstuffs and it is technically impossible to carry out the test described in paragraph 5, modifications to that test are acceptable, provided that they enable the level of migration occurring during the third test to be determined. One of these possible modifications is described below.The test is carried out on three identical samples of the material or article. One of these shall be subjected to the appropriate test and the overall migration determined (M1). The second and third samples shall be subjected to the same conditions of temperature but the period of contact shall be two and three times that specified and overall migration determined in each case (M2 and M3, respectively).The material or article shall be deemed to be in compliance provided that either M1 or M3 - M2 do not exceed the overall migration limit.7. A material or article that exceeds the overall migration limit by an amount not greater than the analytical tolerance mentioned below should therefore be deemed to be in compliance with this Directive.The following analytical tolerances have been observed:- 20 mg/kg or 3 mg/dm2 in migration tests using rectified olive oil or substitutes,- 12 mg/kg or 2 mg/dm2 in migration tests using the other simulants referred to in Directives 82/711/EEC and 85/572/EEC.8. Without prejudice to the provisions of Article 3(2) of Directive 82/711/EEC, migration tests using rectified olive oil or substitutes shall not be carried out to check compliance with the overall migration limit in cases where there is conclusive proof that the specified analytical method is inadequate from a technical standpoint.In any such case, for substances exempt from specific migration limits or other restrictions in the list provided in Annex II, a generic specific migration limit of 60 mg/kg or 10 mg/dm2, according to the case, is applied. However, the sum of all specific migrations determined shall not exceed the overall migration limit.ANNEX IILIST OF MONOMERS AND OTHER STARTING SUBSTANCES WHICH MAY BE USED IN THE MANUFACTURE OF PLASTIC MATERIALS AND ARTICLESGENERAL INTRODUCTION1. This Annex contains the list of monomers or other starting substances. The list includes:- substances undergoing polymerisation, which includes polycondensation, polyaddition or any other similar process, to manufacture macromolecules,- natural or synthetic macromolecular substances used in the manufacture of modified macromolecules, if the monomers or the other starting substances required to synthesise them are not included in the list,- substances used to modify existing natural or synthetic substances.2. The list does not include the salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium and zinc of the authorised acids, phenols or alcohols which are also authorised. However, names containing "... acid(s), salts" appear in the lists if the corresponding free acid(s) is (are) not mentioned. In each case the meaning of the term "salts" is "salts of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium and zinc".3. The list also does not include the following substances although they may be present:(a) substances which could be present in the finished product as:- impurities in the substances used,- reaction intermediates,- decomposition products;(b) oligomers and natural or synthetic macromolecular substances as well as their mixtures, if the monomers or starting substances required to synthesise them are included in the list;(c) mixtures of the authorised substances.The materials and articles, which contain the substances indicated under points (a), (b) and (c) shall comply with the requirements stated in Article 2 of Directive 89/109/EEC.4. Substances shall be of good technical quality as regards the purity criteria.5. The list contains the following information:- column 1 (Ref. No): the EEC packaging material reference number of the substances on the list,- column 2 (CAS No): the CAS (Chemical Abstracts Service) registry number,- column 3 (Name): the chemical name,- column 4 (Restrictions and/or specifications): These may include:- specific migration limit (SML),- maximum permitted quantity of the substance in the finished material or article (QM),- maximum permitted quantity of the substance in the finished material or article expressed as mg per 6 dm2 of the surface in contact with foodstuffs (QMA),- any other restriction specifically mentioned,- any type of specifications related to the substance or to the polymer.6. If a substance appearing on the list as an individual compound is also covered by a generic term, the restrictions applying to this substance shall be those indicated for the individual compound.7. Where there is any inconsistency between the CAS number and the chemical name, the chemical name shall take precedence over the CAS number. If there is an inconsistency between the CAS number reported in Einecs and the CAS Registry, the CAS number in the CAS Registry shall apply.8. A number of abbreviations or expressions are used in column 4 of the table, the meanings of which are as follows:DL= Detection limit of the method of analysis;FP= Finished material or article;NCO= Isocyanate moiety;ND= not detectable. For the purpose of this Directive "not detectable" means that the substance should not be detected by a validated method of analysis which should detect it at the detection limit (DL) specified. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the detection limit may be used, pending the development of a validated method;QM= Maximum permitted quantity of the "residual" substance in the material or article;QM(T)= Maximum permitted quantity of the "residual" substance in the material or article expressed as total of moiety or substance(s) indicated. For the purpose of this Directive the quantity of the substance in the material or article should be determined by a validated method of analysis. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the specified limit may be used, pending the development of a validated method;QMA= Maximum permitted quantity of the "residual" substance in the finished material or article expressed as mg per 6 dm2 of the surface in contact with foodstuffs. For the purpose of this Directive the quantity of the substance in the surface of the material or article should be determined by a validated method of analysis. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the specified limit may be used, pending the development of a validated method;QMA(T)= Maximum permitted quantity of the "residual" substance in the material or article expressed as mg of total of moiety or substance(s) indicated per 6 dm2 of the surface in contact with foodstuffs. For the purpose of this Directive the quantity of the substance in the surface of the material or article should be determined by a validated method of analysis. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the specified limit may be used, pending the development of a validated method;SML= Specific migration limit in food or in food simulant, unless it is specified otherwise. For the purpose of this Directive the specific migration of the substance should be determined by a validated method of analysis. If such a method does not currently exist, an analytical method with appropriate performance characteristics at the specified limit may be used, pending the development of a validated method;SML(T)= Specific migration limit in food or in food simulant expressed as total of moiety or substance(s) indicated. For the purpose of this Directive the specific migration of the substances should be determined by a validated method of analysis If such a method does not currently exist, an analytical method with appropriate performance characteristics at the specified limit may be used, pending the development of a validated method.Section AList of authorised monomers and other starting substances>TABLE>Section BList of monomers and other starting substances which may continue to be used pending a decision on inclusion in Section A>TABLE>ANNEX IIIINCOMPLETE LIST OF ADDITIVES WHICH MAY BE USED IN THE MANUFACTURE OF PLASTIC MATERIALS AND ARTICLESGENERAL INTRODUCTION1. This Annex contains the list of:(a) substances which are incorporated into plastics to achieve a technical effect in the finished product. They are intended to be present in the finished articles;(b) substances used to provide a suitable medium in which polymerization occurs (e.g. emulsifiers, surfactants, buffering agents etc.).The list does not include the substances, which directly influence the formation of polymers (e.g. the catalytic system).2. The list does not include the salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium and zinc of the authorised acids, phenols or alcohols which are also authorised. However, names containing "...acid(s), salts" appear in the lists if the corresponding free acid(s) is (are) not mentioned. In such cases the meaning of the term "salts" is "salts of aluminium ammonium, calcium, iron, magnesium, potassium, sodium and zinc".3. The list does not include the following substances although they may be present:(a) substances which could be present in the finished product such as:- impurities in the substances used,- reaction intermediates,- decomposition products;(b) mixtures of the authorised substances.The materials and articles which contain the substances indicated in (a) and (b) shall comply with the requirements stated in article 2 of Directive 89/109/EEC.4. Substances shall be of good technical quality as regards the purity criteria.5. The list contains the following information:- column 1 (Ref. No): the EEC packaging material reference number of the substances on the list,- column 2 (CAS No): the CAS (Chemical Abstracts Service) registry number,- column 3 (Name): the chemical name,- column 4 (Restrictions and/or specifications). These may include:- specific migration limit (SML),- maximum permitted quantity of the substance in the finished material or article (QM),- maximum permitted quantity of the substance in the finished material or article expressed as mg per 6 dm2 of the surface in contact with foodstuffs (QMA),- any other restriction specifically laid down,- any type of specification related to the substance or polymer.6. If a substance appearing on the list as an individual compound is also covered by a generic term, the restrictions applying to this substance shall be those indicated for the individual compound.7. Where there is any inconsistency between the CAS number and the chemical name, the chemical name shall take precedence over the CAS number. If there is an inconsistency between the CAS number reported in EINECS and the CAS registry, the CAS number in the CAS registry shall apply.Section AIncomplete list of additives fully harmonised at Community level>TABLE>Section BIncomplete list of additives referred to in Article 4, second paragraph>TABLE>ANNEX IVPRODUCTS OBTAINED BY MEANS OF BACTERIAL FERMENTATION>TABLE>ANNEX VSPECIFICATIONSPart A: General specificationsThe material and article manufactured by using aromatic isocyanates or colorants prepared by diazo-coupling, shall not release primary aromatic amines (expressed as aniline) in a detectable quantity (DL = 0,02 mg/kg of food or food simulant, analytical tolerance included). However, the migration value of the primary aromatic amines listed in this Directive are excluded from this restriction.Part B: Other specifications>TABLE>ANNEX VINOTES RELATED TO THE COLUMN "RESTRICTIONS AND/OR SPECIFICATIONS"(1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24) (25)(26)(1) Warning: there is a risk that the SML could be exceeded in fatty food simulants.(2) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as Ref. Nos: 10060 and 23920.(3) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as Ref. Nos: 15760, 16990, 47680, 53650 and 89440.(4) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as Ref. Nos: 19540, 19960 and 64800.(5) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as Ref. Nos: 14200, 14230 and 41840.(6) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as Ref. Nos: 66560 and 66580.(7) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 30080, 42320, 45195, 45200, 53610, 81760, 89200 and 92030.(8) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 42400, 64320, 73040, 85760, 85840, 85920 and 95725.(9) Warning: there is a risk that the migration of the substance deteriorates the organoleptic characteristics of the food in contact and then, that the finished product does not comply with the second indent of Article 2 of Directive 89/109/EEC.(10) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 30180, 40980, 63200, 65120, 65200, 65280, 65360, 65440 and 73120.(11) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 45200, 64320, 81680 and 86800.(12) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 36720, 36800, 36840, and 92000.(13) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 39090 and 39120.(14) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 44960, 68078, 82020 and 89170.(15) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 15970, 48640, 48720, 48880, 61280, 61360 and 61600.(16) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 49600, 67520 and 83599.(17) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 50160, 50240, 50320, 50360, 50400, 50480, 50560, 50640, 50720, 50800, 50880, 50960, 51040 and 51120.(18) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 67600, 67680 and 67760.(19) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 60400, 60480 and 61440.(20) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 66400 and 66480.(21) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 93120 and 93280.(22) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 17260 and 18670.(23) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 13620, 36840, 40320 and 87040.(24) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 13720 and 40580.(25) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as Ref. Nos: 16650 and 51570.(26) QM(T) in this specific case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances mentioned as Ref. Nos: 14950, 15700, 16240, 16570, 16600, 16630, 18640, 19110, 22332, 22420, 22570, 25210, 25240 and 25270.ANNEX VIIPart AREPEALED DIRECTIVE AND ITS AMENDMENTS(Referred to by Article 10(1))Commission Directive 90/128/EEC (OJ L 349, 13.12.1990, p. 26)Commission Directive 92/39/EEC (OJ L 168, 23.6.1992, p. 21)Commission Directive 93/9/EEC (OJ L 90, 14.4.1993, p. 26)Commission Directive 95/3/EC (OJ L 41, 23.2.1995, p. 44)Commission Directive 96/11/EC (OJ L 61, 12.3.1996, p. 26)Commission Directive 1999/91/EC (OJ L 310, 4.12.1999, p. 41)Commission Directive 2001/62/EC (OJ L 221, 17.8.2001, p. 18)Commission Directive 2002/17/EC (OJ L 58, 28.2.2002, p. 19)Part BDEADLINES FOR TRANSPOSITION INTO NATIONAL LAW(Referred to by Article 10(1))>TABLE>ANNEX VIIICORRELATION TABLE>TABLE>


title: Council Directive 2008/71/EC of 15 July 2008 on the identification and registration of pigs (Codified version)

text:
               8.8.2008

               EN

               Official Journal of the European Union

               L 213/31

      COUNCIL DIRECTIVE 2008/71/EC
   of 15 July 2008
   on the identification and registration of pigs
   (Codified version)
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof,
   Having regard to the proposal from the Commission,
   Having regard to the opinion of the European Parliament (1),
   Whereas:

               (1)

               Council Directive 92/102/EEC of 27 November 1992 on the identification and registration of animals (2) has been substantially amended several times (3). In the interests of clarity and rationality the said Directive should be codified.

               (2)

               Pursuant to Article 3(1)(c) of Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market (4), animals for intra-Community trade must be identified in accordance with the requirements of Community rules and be registered in such a way that the original or transit holding, centre or organisation can be traced. Before 1 January 1993, those identification and registration systems had to be extended to the movements of animals within the territory of each Member State.

               (3)

               Article 14 of Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organisation of veterinary checks on animals entering the Community from third countries (5) states that the identification and registration provided for in Article 3(1)(c) of Directive 90/425/EEC of such animals must, except in the case of animals for slaughter and registered equidae, be carried out after the said checks have been made.

               (4)

               It is necessary to ensure the rapid and efficient exchange of information between Member States for the correct application of this Directive. Community provisions have been laid down by Council Regulation (EC) No 515/97 of 13 March 1997 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of the law on customs and agricultural matters (6) and by Council Directive 89/608/EEC of 21 November 1989 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of legislation on veterinary and zootechnical matters (7).

               (5)

               Keepers of animals should maintain up-to-date records of the animals on their holdings. Persons involved in the commerce of animals should keep records of their dealings. The competent authority should have access to these records on request.

               (6)

               In order to permit movements of animals to be traced rapidly and accurately, animals should be able to be identified. A decision should be taken at a later date to determine the nature of the mark and, pending such decision, the national systems of identification should be maintained for movements restricted to the national market.

               (7)

               Provision should be made for the possibility of waiving the requirements for marks in the case of animals moving directly from a farm to a slaughterhouse. However, these animals should in any case be identified so that their farm of origin can be traced.

               (8)

               Provision should be made for the possibility of waiving the obligation to register the keepers of animals kept for personal purposes and, in order to take into account certain particular cases, the procedures for keeping registers.

               (9)

               In the case of animals in which the mark has become illegible or been lost, a new mark enabling a link with the previous mark to be established should be applied.

               (10)

               This Directive should not affect specific requirements set out in Commission Decision 89/153/EEC of 13 February 1989 concerning the correlation of samples taken for residue examination with animals and their farms of origin (8) or any relevant applicatory rules established in accordance with Directive 91/496/EEC.

               (11)

               Provision should be made for a management committee procedure for the adoption of any necessary implementing rules for this Directive.

               (12)

               This Directive should be without prejudice to the obligations of the Member States relating to the time limits for transposition into national law of the Directive set out in Annex I, Part B,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   This Directive sets out the minimum requirements for the identification and registration of pigs, without prejudice to more detailed Community rules which may be established for disease eradication or control purposes.
   It shall apply without prejudice to Decision 89/153/EEC and to implementing rules laid down in accordance with Directive 91/496/EEC.
   Article 2
   For the purposes of this Directive, the following definitions shall apply:

               (a)

               ‘animal’ means any animal of the Suidae family, excluding feral pigs as defined in Article 2(b) of Council Directive 2001/89/EC of 23 October 2001 on Community measures for the control of classical swine fever (9);

               (b)

               ‘holding’ means any establishment, construction or, in the case of an open-air farm, any place in which animals are held, kept or handled;

               (c)

               ‘keeper’ means any natural or legal person responsible, even on a temporary basis, for animals;

               (d)

               ‘competent authority’ means the central authority of a Member State competent to carry out veterinary checks or any authority to which it has delegated that competence for the purposes of implementing this Directive;

               (e)

               ‘trade’ means trade as defined in point (3) of Article 2 of Directive 90/425/EEC.

         Article 3
   1.   Member States shall ensure that:

               (a)

               the competent authority has an up-to-date list of all the holdings which keep animals covered by this Directive and are situated on its territory, specifying the keepers of the animals; such holdings must remain on that list until three consecutive years have elapsed with no animals on the holding. That list must also include the mark or marks which permit the identification of the holding in accordance with the first subparagraph of Article 5(2) and Article 8;

               (b)

               the Commission and the competent authority can have access to all information obtained under this Directive.

         2.   Member States may be authorised in accordance with the procedure referred to in Article 18 of Directive 90/425/EEC to exclude from the list in paragraph 1(a) of this Article natural persons who keep one single animal which is intended for their own use or consumption, or to take account of particular circumstances, provided that this animal is subjected to the controls laid down in this Directive before any movement.
   Article 4
   1.   Member States shall ensure that any keeper contained in the list provided for in Article 3(1)(a) keeps a register stating the number of animals present on the holding.
   That register shall include an up-to-date record of movements (numbers of animals concerned by each entering and leaving operation) at least on the basis of aggregate movements, stating as appropriate their origin or destination, and the date of such movements.
   The identification mark applied in conformity with Articles 5 and 8 shall be stated in all cases.
   In the case of pure-bred and hybrid pigs, which are entered in a herd-book in accordance with Council Directive 88/661/EEC of 19 December 1988 on the zootechnical standards applicable to breeding animals of the porcine species (10), an alternative registration system based on individual identification allowing the animals to be identified may be recognised in accordance with the procedure referred to in Article 18 of Directive 90/425/EEC if it offers guarantees equivalent to a register.
   2.   Member States shall also ensure that:

               (a)

               any keeper supplies the competent authority, upon request, with all information concerning the origin, identification and, where appropriate, the destination of animals which he has owned, kept, transported, marketed or slaughtered;

               (b)

               any keeper of animals to be moved to or from a market or collection centre provides a document, containing details of the animals in question, to the operator, on the market or in the collection centre, who is a keeper of the animals, on a temporary basis.
               That operator may use the documents obtained in accordance with the first subparagraph to carry out the obligations laid down in the third subparagraph of paragraph 1;

               (c)

               the registers and information are available on the holding and to the competent authority, upon request, for a minimum period to be determined by the competent authority but which may not be less than three years.

         Article 5
   1.   Member States shall ensure that the following general principles are respected:

               (a)

               identification marks must be applied before animals leave the holding of birth;

               (b)

               no mark may be removed or replaced without the permission of the competent authority.
               Where a mark has become illegible or has been lost, a new mark shall be applied in accordance with this Article;

               (c)

               the keeper shall record any new mark in the register referred to in Article 4 in order to establish a link with the previous mark applied to the animal.

         2.   Animals must be marked as soon as possible, and in any case before they leave the holding, with an eartag or tattoo making it possible to determine the holding from which they came and enabling reference to be made to any accompanying document which must mention such eartag or tattoo and to the list referred to in Article 3(1)(a).
   Member States may, by derogation from the second subparagraph of Article 3(1)(c) of Directive 90/425/EEC, apply their national systems for all movements of animals in their territories. Such systems must enable the holding from which they came and the holding on which they were born to be identified. Member States shall notify the Commission of the systems which they intend to introduce for this purpose. In accordance with the procedure referred to in Article 18 of Directive 90/425/EEC, a Member State may be asked to make amendments to its system where it does not fulfil that requirement.
   Animals bearing a temporary mark identifying a consignment must be accompanied throughout their movement by a document which enables the origin, ownership, place of departure and destination to be determined.
   Article 6
   1.   Where the competent authority of the Member State of destination decides not to keep the identification mark allocated to the animal in the holding of origin all charges incurred as a result of replacing the mark shall be borne by that authority. Where the mark has been so replaced, a link shall be established between the identification allocated by the competent authority of the Member State of dispatch and the new identification allocated by the competent authority of the Member State of destination; that link shall be recorded in the register provided for in Article 4.
   The option in the first subparagraph may not be invoked in the case of animals intended for slaughter which are imported under Article 8 without bearing a new mark in accordance with Article 5.
   2.   Where the animals have been traded, the competent authority of the Member State of destination may, for the purposes of Article 5 of Directive 90/425/EEC, have recourse to Article 4 of Directive 89/608/EEC in order to obtain the information relating to the animals, their herd of origin and any movement to which they have been subject.
   Article 7
   Member States shall ensure that any information relating to movements of animals not accompanied by a certificate or a document required by veterinary or zootechnical legislation remains available to the competent authority, upon request, for a minimum period to be set by the latter.
   Article 8
   Any animal imported from a third country which has passed the checks laid down by Directive 91/496/EEC and which remains within Community territory shall, within thirty days of undergoing those checks, and, in any event, before their movement, be identified by a mark complying with Article 5 of this Directive unless the holding of destination is a slaughterhouse situated on the territory of the competent authority responsible for veterinary checks and the animal is actually slaughtered within that 30-day period.
   A link shall be established between the identification established by the third country and the identification allocated to it by the Member State of destination. That link shall be recorded in the register provided for in Article 4.
   Article 9
   Member States shall adopt necessary administrative and/or penal measures to punish any infringement of Community veterinary legislation, where it is established that the marking or identification or the keeping of registers provided for in Article 4 has not been carried out in conformity with the requirements of this Directive.
   Article 10
   Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive.
   Article 11
   Directive 92/102/EEC, as amended by the acts listed in Annex I, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time limits for transposition into national law of the Directive set out in Annex I, Part B.
   References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table set out in Annex II.
   Article 12
   This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
   Article 13
   This Directive is addressed to the Member States.

      Done at Brussels, 15 July 2008.

            For the Council

            The President

         M. BARNIER

      (1)  Opinion of 11 March 2008 (not yet published in the Official Journal).

      (2)  OJ L 355, 5.12.1992, p. 32. Directive as last amended by Regulation (EC) No 21/2004 (OJ L 5, 9.1.2004, p. 8).

      (3)  See Annex I, Part A.

      (4)  OJ L 224, 18.8.1990, p. 29. Directive as last amended by Directive 2002/33/EC of the European Parliament and of the Council (OJ L 315, 19.11.2002, p. 14).

      (5)  OJ L 268, 24.9.1991, p. 56. Directive as last amended by Directive 2006/104/EC (OJ L 363, 20.12.2006, p. 352).

      (6)  OJ L 82, 22.3.1997, p. 1. Regulation as amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).

      (7)  OJ L 351, 2.12.1989, p. 34.

      (8)  OJ L 59, 2.3.1989, p. 33.

      (9)  OJ L 316, 1.12.2001, p. 5. Directive as last amended by Commission Decision 2007/729/EC (OJ L 294, 13.11.2007, p. 26).

      (10)  OJ L 382, 31.12.1988, p. 36. Directive as last amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).

      ANNEX I
      PART A
      Repealed Directive with list of its successive amendments
      (referred to in Article 11)

                  Council Directive 92/102/EEC
                  (OJ L 355, 5.12.1992, p. 32)

                  Point V.E.I.4.6. of Annex I to the 1994 Act of Accession
                  (OJ C 241, 29.8.1994, p. 21)

                  Council Regulation (EC) No 21/2004
                  (OJ L 5, 9.1.2004, p. 8)

                  only Article 15

            PART B
      List of time limits for transposition into national law
      (referred to in Article 11)

                  Directive

                  Time limit for transposition (1)

                  92/102/EEC

                  31.12.1993 (2)

                  31.12.1995 (3)

         (1)  The setting of the deadline for transposition into national law at 1 January 1994 shall be without prejudice to the abolition of veterinary checks at frontiers provided for in Directive 90/425/EEC (see Article 11(3) of Directive 92/102/EEC).

         (2)  For the requirements regarding porcine animals (see the first indent of Article 11(1) of Directive 92/102/EEC).

         (3)  For Finland, as concerns the requirements for bovine animals, swine, sheep and goats (see the second indent of Article 11(1) of Directive 92/102/EEC).

      ANNEX II
      CORRELATION TABLE

                  Directive 92/102/EEC

                  This Directive

                  Articles 1, 2 and 3

                  Articles 1, 2 and 3

                  Article 4(1)(a)

                  Article 4(1)

                  Article 4(2)

                  —

                  Article 4(3)

                  Article 4(2)

                  Article 5(1), points (a), (b) and (c)

                  Article 5(1), points (a), (b) and (c)

                  Article 5(1)(d)

                  —

                  Article 5(3)

                  Article 5(2)

                  Articles 6 to 9

                  Articles 6 to 9

                  Article 10

                  —

                  Article 11(1)

                  —

                  Article 11(2)

                  Article 10

                  Article 11(3)

                  —

                  —

                  Article 11

                  —

                  Article 12

                  Article 12

                  Article 13

                  —

                  Annex I

                  —

                  Annex II


Avis juridique important

|

31976L0629

Council Directive 76/629/EEC of 20 July 1976 amending for the twelfth time Directive 64/54/EEC on the approximation of the laws of the Member States concerning the preservatives authorized for use in foodstuffs intended for human consumption

Official Journal L 223 , 16/08/1976 P. 0003 - 0003 Greek special edition: Chapter 03 Volume 16 P. 0087  Spanish special edition: Chapter 13 Volume 5 P. 0034  Portuguese special edition Chapter 13 Volume 5 P. 0034

+++++( 1 ) OJ NO C 159 , 12 . 7 . 1976 , P . 42 .  ( 2 ) OPINION DELIVERED 1 JULY 1976 AND NOT YET PUBLISHED IN THE OFFICIAL JOURNAL .  ( 3 ) OJ NO 12 , 27 . 1 . 1964 , P . 161/64 .  ( 4 ) OJ NO L 126 , 14 . 5 . 1976 , P . 31 .  ( 5 ) OJ NO L 208 , 30 . 7 . 1974 , P . 25 .  COUNCIL DIRECTIVE OF 20 JULY 1976 AMENDING FOR THE TWELFTH TIME DIRECTIVE 64/54/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES CONCERNING THE PRESERVATIVES AUTHORIZED FOR USE IN FOODSTUFFS INTENDED FOR HUMAN CONSUMPTION ( 76/629/EEC )  THE COUNCIL OF THE EUROPEAN COMMUNITIES ,  HAVING REGARD TO THE TREATY ESTABLISHING THE EUROPEAN ECONOMIC COMMUNITY , AND IN PARTICULAR ARTICLE 100 THEREOF ,  HAVING REGARD TO THE PROPOSAL FROM THE COMMISSION ,  HAVING REGARD TO THE OPINION OF THE EUROPEAN PARLIAMENT ( 1 ) ,  HAVING REGARD TO THE OPINION OF THE ECONOMIC AND SOCIAL COMMITTEE ( 2 ) ,  WHEREAS COUNCIL DIRECTIVE 64/54/EEC OF 5 NOVEMBER 1963 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES CONCERNING THE PRESERVATIVES AUTHORIZED FOR USE IN FOODSTUFFS INTENDED FOR HUMAN CONSUMPTION ( 3 ) , AS LAST AMENDED BY DIRECTIVE 76/462/EEC ( 4 ) , PROVIDES FOR THE TEMPORARY USE OF THIABENDAZOLE AT A MAXIMUM LEVEL OF 6 MG/KG IN THE CASE OF CITRUS FRUIT AND 3 MG/KG IN THE CASE OF BANANAS ;  WHEREAS ON A TOXICOLOGICAL BASIS , THE USE OF THIABENDAZOLE ON THE SURFACE OF CITRUS FRUIT IN QUANTITIES LEADING TO RESIDUES OF 6 MG/KG IN THE WHOLE FRUIT IS TEMPORARILY ACCEPTABLE , BUT ALL USES OF THIABENDAZOLE LEADING TO ITS PRESENCE IN FOODSTUFFS SHOULD BE TAKEN INTO CONSIDERATION BEFORE TAKING A FINAL DECISION ;  WHEREAS EXPERIENCE IN THE USE OF THIABENDAZOLE HAS SHOWN THAT THE MAINTENANCE OF THESE LEVELS IS TECHNOLOGICALLY JUSTIFIED BECAUSE OF ITS FUNGICIDAL PROPERTIES ;  WHEREAS THE TRANSITIONAL PERIOD PROVIDED FOR BY DIRECTIVE 74/394/EEC ( 5 ) SHOULD THEREFORE BE EXTENDED TO ALLOW TIME FOR AN OVERALL EXAMINATION OF THE SOURCES AND OF THE PRESENCE OF THIABENDAZOLE IN FOODSTUFFS , WITHOUT PREJUDICE TO THE POSSIBLE INCLUSION OF THIABENDAZOLE IN A SUBSEQUENT COMMUNITY SYSTEM ON THE TREATMENT OF FRUITS AND VEGETABLES ,  HAS ADOPTED THIS DIRECTIVE :  ARTICLE 1  IN NO E 233 SUBPARAGRAPH ( C ) OF SECTION I OF THE ANNEX TO DIRECTIVE 64/54/EEC " 1 JULY 1976 " SHALL BE REPLACED BY " 1 JANUARY 1979 " .  ARTICLE 2  MEMBER STATES SHALL BRING INTO FORCE THE LAWS , REGULATIONS OR ADMINISTRATIVE PROVISIONS NECESSARY TO COMPLY WITH THIS DIRECTIVE WITH EFFECT FROM 1 JULY 1976 AND SHALL FORTHWITH INFORM THE COMMISSION THEREOF .  ARTICLE 3  THIS DIRECTIVE IS ADDRESSED TO THE MEMBER STATES .  DONE AT BRUSSELS , 20 JULY 1976 .  FOR THE COUNCIL  THE PRESIDENT  A . P . L . M . M . VAN DER STEE


title: Commission Directive 2006/19/EC of  14 February 2006  amending Council Directive 91/414/EEC to include 1-methylcyclopropene as active substance   (Text with EEA relevance)

text:
               15.2.2006

               EN

               Official Journal of the European Union

               L 44/15

      COMMISSION DIRECTIVE 2006/19/EC
   of 14 February 2006
   amending Council Directive 91/414/EEC to include 1-methylcyclopropene as active substance
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               In accordance with Article 6(2) of Directive 91/414/EEC the Netherlands received on 28 February 2002 an application from Rohm and Haas France S.A. for the inclusion of the active substance 1-methylcyclopropene in Annex I to Directive 91/414/EEC. Commission Decision 2003/35/EC (2) confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

               (2)

               For this active substance, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member States submitted a draft assessment report concerning the substance to the European Food Safety Authority (EFSA) on 22 March 2003.

               (3)

               The assessment report has been peer reviewed by the Member States and the EFSA within its Working Group Evaluation and presented to the Commission on 14 January 2005 in the format of the EFSA Scientific Report for 1-methylcyclopropene (3). This report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 23 September 2005 in the format of the Commission review report for 1-methylcyclopropene.

               (4)

               The review of 1-methylcyclopropene did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants or of the European Food Safety Authority which has taken over the role of that Committee.

               (5)

               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) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include 1-methylcyclopropene in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive.

               (6)

               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 provisional authorisations of plant protection products containing 1-methylcyclopropene 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 transform existing provisional authorisations into full authorisations, amend them or withdraw them 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.

               (7)

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

               (8)

               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
   1.   Member States shall adopt and publish by 30 September 2006 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 October 2006.
   When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing 1-methylcyclopropene as active substance by 30 September 2006. By that date, they shall in particular verify that the conditions in Annex I to that Directive relating to 1-methylcyclopropene are met, with the exception of those identified in part B of the entry concerning the active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13.2.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing 1-methylcyclopropene 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 March 2006 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 1-methylcyclopropene. 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 1-methylcyclopropene as the only active substance, where necessary, amend or withdraw the authorisation by 30 September 2007 at the latest; or

               (b)

               in the case of a product containing 1-methylcyclopropene as one of several active substances, where necessary, amend or withdraw the authorisation by 30 September 2007 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 April 2006.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 14 February 2006.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2006/6/EC (OJ L 12, 18.1.2006, p. 21).

      (2)  OJ L 11, 16.1.2003, p. 52.

      (3)  EFSA Scientific Report (2005) 30, 1-46, Conclusion regarding the peer review of the pesticide risk assessment of the active substance 1-methylcyclopropene (finalised: 14 January 2005).

      ANNEX

         In Annex I to Directive 91/414/EEC, the following rows are added at the end of the table

                     No

                     Common name, identification numbers

                     IUPAC name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘118

                     1-methylcyclopropene (an ISO Common Name will not be considered for this active substance)
                     CAS No 3100-04-7
                     CIPAC No not allocated

                     1-methylcyclopropene

                     ≥ 960 g/kg
                     The manufacturing impurities 1-chloro-2-methylpropene and 3-chloro-2-methylpropene are of toxicological concern and each of them must not exceed 0,5 g/kg in the technical material.

                     1 April 2006

                     31 March 2016

                     PART A
                     Only uses as plant growth regulator for post harvest storage in sealable warehouse may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on 1-methylcyclopropene, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 September 2005 shall be taken into account.

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