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31974L0268

Commission Directive 74/268/EEC of 2 May 1974 laying down special conditions concerning the presence of 'Avena fatua' in fodder plant and cereal seed

Official Journal L 141 , 24/05/1974 P. 0019 - 0019 Finnish special edition: Chapter 3 Volume 6 P. 0005  Greek special edition: Chapter 03 Volume 10 P. 0220  Swedish special edition: Chapter 3 Volume 6 P. 0005  Spanish special edition: Chapter 03 Volume 7 P. 0214  Portuguese special edition Chapter 03 Volume 7 P. 0214

COMMISSION DIRECTIVE  of 2 May 1974  laying down special conditions concerning the presence of "Avena fatua" in fodder plant and cereal seed  (74/268/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community;  Having regard to the Council Directives of 14 June 1966, on the marketing of fodder plant seed (1) and on the marketing of cereal seed (2), as last amended by the Council Directive of 11 December 1973 (3), and in particular Article 11 thereof;  Whereas the abovementioned Directives have laid down tolerances in respect of the presence of Avena fatua in fodder plant and cereal seed;  Whereas these tolerances appear too high with regard to certain requirements, the abovementioned Directives, consequently, provide for an additional marking in the case of seed complying with special conditions concerning the presence of Avena fatua;  Whereas the special conditions laid down in this connection are such as to satisfy the abovementioned requirements while also taking account of the possibilities for the production and control of seed;  Whereas the measures provided for in this Directive are in accordance with the Opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture, and Forestry,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Member States shall issue on request the official certificate provided for in Article 11 of the Directive on the marketing of fodder plant seed,    (a) in the case of seeds of a size not less than that of a grain of wheat, if a sample of at least 500 g, drawn in accordance with the provisions of Article 7 of the abovementioned Directive, is free of Avena fatua at the time of official examination;       (b) in the case of seeds of a size smaller than a grain of wheat,       - if the crop is free of Avena fatua at the time of field inspection officially carried out in conformity with the provisions of Annex I to the abovementioned Directive and if a sample of at least 100 g, drawn in accordance with the provisions of Article 7 of the abovementioned Directive, is free of Avena fatua at the time of official examination, or       - if a sample of at least 300 g, drawn in accordance with the provisions of Article 7 of the abovementioned Directive, is free of Avena fatua at the time of official examination.         Article 2 1. Member States shall issue the official certificate provided for in Article 11 of the Directive on the marketing of cereal seed,    - if the crop is free of Avena fatua at the time of field inspection officially carried out in conformity with the provisions of Annex 1 of the abovementioned Directive and if a sample of a least 1 kg, drawn in accordance with the provisions of Article 7 of the abovementioned Directive is free of Avena fatua at the time of official examination, or       - if a sample of at least 3 kg, drawn in accordance with the provisions of Article 7 of the abovementioned Directive, is free of Avena fatua at the time of official examination.          Article 3 Member States may prescribe that the official certificate is issued only in one of the two cases provided for in Article 1 (b) and Article 2 respectively.   Article 4 Member States shall bring into force, not later than 1 July 1974, the laws, regulations or administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission, who shall inform the other Member States, thereof.   Article 5 This Directive is addressed to the Member States.     Done at Brussels, 2 May 1974.  For the Commission  The President  François-Xavier ORTOLI  (1)OJ No 125, 11.7.1966, p. 2298/66. (2)OJ No 125, 11.7.1966, p. 2309/66. (3)OJ No L 356, 27.12.1973, p. 79.


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32000L0081

Commission Directive 2000/81/EC of 18 December 2000 amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables, respectively (Text with EEA relevance)

Official Journal L 326 , 22/12/2000 P. 0056 - 0062

Commission Directive 2000/81/ECof 18 December 2000amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables, respectively(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals(1), as last amended by Directive 2000/58/EC(2), and in particular Article 10 thereof,Having regard to Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin(3), as last amended by Directive 2000/58/EC, and in particular Article 10 thereof,Having regard to Council Directive 90/642/EEC of 27 November 1990 on fixing of maximum levels for pesticide residues in and on certain products of plant origin including fruit and vegetables(4), as last amended by Directive 2000/58/EC, and in particular Article 7 thereof,Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(5), as last amended by Commission Directive 2000/68/EC(6), and in particular Article 4(1)(f) thereof,Whereas:(1) The new active substance, spiroxamine, was included in Annex I to Directive 91/414/EEC by Commission Directive 1999/73/EC(7) for use as fungicide only, without specifying particular conditions having an impact on crops which may be treated with plant protection products containing spiroxamine.(2) The said inclusion in Annex I was based on assessment of the information submitted concerning proposed use as fungicide on cereals and vines. Information relating to uses on cereals and vines has been submitted by certain Member States in accordance with the requirements of Article 4(1)(f) of Directive 91/414/EEC. The information available has been reviewed and is sufficient to fix certain maximum residue levels.(3) Where no Community maximum residue level or provisional MRL exists Member States shall establish a national provisional maximum residue level in accordance with Article 4(1)(f) of Directive 91/414/EEC before the authorisation may be granted.(4) At the inclusion in Annex I to Directive 91/414/EEC the technical and scientific evaluation of spiroxamine has been finalised on 12 May 1999 in the format of the Commission review report for spiroxamine. In this review report the acceptable daily intake (ADI) for spiroxamine was set at 0,025 mg/kg bw/day. The lifetime exposure of consumers of food products treated with spiroxamine has been assessed and evaluated in accordance with the procedures and practices used within the European Community, taking account of guidelines published by the World Health Organisation(8) and it has been calculated that the maximum residue levels fixed in this Directive do not give rise to an exceedence of this ADI.(5) Acute toxic effects requiring the setting of an acute reference dose were not noted during the evaluation and discussion that preceded the inclusion of spiroxamine in Annex I to Directive 91/414/EEC.(6) For certain agricultural products the use conditions for spiroxamine were already defined in a manner which permits the establishing of definitive maximum residue levels.(7) To ensure that the consumer is adequately protected from exposure to residues in or on products for which no authorisations have been granted, it is prudent to set provisional maximum residue levels at the lower limit of analytical determination for all those products covered by Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC. The setting at Community level of such provisional maximum residue levels does not prevent the Member States from establishing provisional maximum residue levels for spiroxamine in accordance with Article 4(1)(f) of Directive 91/414/EEC, and in accordance with Annex VI to Directive 91/414/EEC, in particular part B, section 2.4.2.3 of this Annex; four years is considered a sufficient period of time during which to establish most further uses of spiroxamine. After that period these provisional maximum residue levels should become definitive.(8) The Community notified the draft Commission Directive to the World Trade Organisation and the comments received have been considered in finalising the Directive. The possibility of fixing import tolerance maximum residue levels for specific pesticide/crop combinations will be examined by the Commission on the basis of the submission of acceptable data.(9) The opinions of the Scientific Committee for Plants, in particular advice and recommendations concerning the protection of consumers of food products treated with pesticides, have been taken into account.(10) This Directive is in accordance with the opinion of the Standing Committee on Plant Health,HAS ADOPTED THIS DIRECTIVE:Article 1The following shall be added to part A of Annex II to Directive 86/362/EEC:">TABLE>"Article 2The following shall be added to part B of Annex II to Directive 86/363/EEC:">TABLE>"Article 3The contents of the Annex to this Directive shall be added to Annex II to Directive 90/642/EEC.Article 41. For those agricultural products listed in Annex II to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC where the maximum residue levels for spiroxamine are indicated as "(p)", this shall mean that they are provisional (p) in accordance with the provisions of Article 4(1)(f) of Directive 91/414/EEC.2. Four years after the entry into force of this Directive, provisional maximum residue levels for spiroxamine in the Annexes shall cease to be provisional and shall become definitive in the sense of Article 4(1) of Directives 86/362/EEC and 86/363/EEC or Article 3 of Directive 90/642/EEC respectively.Article 51. This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.2. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 July 2001 at the latest. They shall forthwith inform the Commission thereof.3. When Member Sates adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.Article 6This Directive is addressed to the Member States.Done at Brussels, 18 December 2000.For the CommissionDavid ByrneMember of the Commission(1) OJ L 221, 7.8.1986, p. 37.(2) OJ L 244, 29.9.2000, p. 78.(3) OJ L 221, 7.8.1986, p. 43.(4) OJ L 350, 14.12.1990, p. 71.(5) OJ L 230, 19.8.1991, p. 1.(6) OJ L 276, 28.10.2000, p. 41.(7) OJ L 206, 5.8.1999, p. 16.(8) Guidelines for predicting dietary intake of pesticide residues (revised), prepared by the GEMS/Food Programme in collaboration with the Codex Committee on Pesticide Residues, published by the World Health Organisation 1997 (WHO/FSF/FOS97.7).ANNEX>TABLE>


title: Commission Directive 2014/106/EU of 5 December 2014 amending Annexes V and VI to Directive 2008/57/EC of the European Parliament and of the Council on the interoperability of the rail system within the Community  Text with EEA relevance

text:
               12.12.2014

               EN

               Official Journal of the European Union

               L 355/42

         COMMISSION DIRECTIVE 2014/106/EU
   of 5 December 2014
   amending Annexes V and VI to Directive 2008/57/EC of the European Parliament and of the Council on the interoperability of the rail system within the Community
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 on the interoperability of the rail system within the Community (1), and in particular Article 30(3) thereof,
   Whereas:

               (1)

               The scope and the content of the ‘EC’ declaration of verification for subsystems should be better defined in Annex V to Directive 2008/57/EC. In particular, the responsibility of the signatory of such declaration should be clearly stated.

               (2)

               The procedures concerning the declaration of verification in case of modifications of existing subsystems and in case of additional verifications carried out by the notified bodies should be clarified in Annex V to Directive 2008/57/EC;

               (3)

               The aim of the verification procedure for subsystems should be clarified in Annex VI to Directive 2008/57/EC. Furthermore, the principles concerning the verification procedure in case of modifications of existing subsystems should be defined in the same Annex.

               (4)

               The measures provided for in this Directive are in accordance with the opinion of the Committee established in accordance with Article 29(1) of Directive 2008/57/EC.

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annexes V and VI to Directive 2008/57/EC are replaced by the text set out in Annexes I and II to this Directive respectively.
   Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 2016 at the latest. They shall forthwith communicate to the Commission the text of those acts.
   When Member States adopt those acts, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   3.   The obligations for transposition and implementation of this Directive shall not apply to the Republic of Cyprus and the Republic of Malta for as long as no railway system is established within their territories.
   Article 3
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 5 December 2014.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 191, 18.7.2008, p. 1.

      ANNEX I

            ‘ANNEX V
            “EC” DECLARATION OF VERIFICATION OF SUBSYSTEMS
            1.   “EC” DECLARATION OF VERIFICATION OF SUBSYSTEMS
            The “EC” declaration of verification of a subsystem is a declaration established by the “applicant” within the meaning of Article 18 in which he declares on his sole responsibility that the subsystem concerned, which has been subject to the relevant verifications procedures, satisfies the requirements of the relevant Union legislation, including any relevant national rules.
            The “EC” declaration of verification and the accompanying documents must be dated and signed.
            The “EC” declaration of verification must be based on the information resulting from the “EC” verification procedure for subsystems set out in Annex VI. It must be written in the same language as the technical file accompanying the “EC” declaration of verification and must contain at least the following:

                        (a)

                        the reference to this Directive, TSIs and applicable national rules,

                        (b)

                        the reference to the TSI(s) or their parts to which conformity has not been examined during EC verification procedure and to the national rules which have been applied in case of a derogation, partial application of TSIs for upgrade or renewal, transitional period in a TSI or specific case,

                        (c)

                        name and address of the “applicant” within the meaning of Article 18 (specifying the trade name and full address; in the case of the authorised representative, specifying also the trade name of the contracting entity or the manufacturer),

                        (d)

                        a brief description of the subsystem,

                        (e)

                        name(s) and address(es) and the identification number(s) of the notified body(ies) which conducted the “EC” verification(s) referred to in Article 18,

                        (f)

                        name(s) and address(es) and the identification number(s) of the notified body(ies) which conducted the assessment of conformity with other regulations deriving from the Treaty,

                        (g)

                        name(s) and address(es) of the designated body(ies) which conducted the verification(s) of conformity with national rules referred to in Article 17(3),

                        (h)

                        name and address of the assessment body(ies) which established the safety assessment reports related to the use of the CSM on risk assessment where required by this Directive,

                        (i)

                        the references of the documents contained in the technical file accompanying the “EC” declaration of verification,

                        (j)

                        all the relevant temporary or final provisions to be complied with by the subsystems and in particular, where appropriate, any operating restrictions or conditions,

                        (k)

                        the identity of the signatory (i.e. the physical person or persons authorised to sign the declaration)

                  Where reference is made in Annex VI to the “intermediate statement of verification” (ISV), the provisions of this Section shall apply to that declaration.
            2.   “EC” DECLARATION OF VERIFICATION OF SUBSYSTEMS IN THE CASE OF MODIFICATIONS
            In a case of a modification, which is not a substitution in the framework of maintenance, of a subsystem covered by an “EC” declaration of verification, without prejudice to Article 20, the following provisions apply.
            2.1.   If the entity introducing the modification demonstrates that the modification does not affect the basic design characteristics of the subsystem which are relevant for the compliance with the requirements concerning the basic parameters:

                        (a)

                        the entity introducing the modification shall update the references of the documents contained in the technical file accompanying the “EC” declaration of verification;

                        (b)

                        no new “EC” declaration of verification needs to be established.

                  2.2.   If the entity introducing the modification demonstrates that the modification affects the basic design characteristics of the subsystem which are relevant for the compliance with the requirements concerning some basic parameters:

                        (a)

                        the entity introducing the modification shall establish a complementary “EC” declaration of verification with reference to the basic parameters concerned;

                        (b)

                        the complementary “EC” declaration of verification shall be accompanied by a list of documents of the original technical file accompanying the original “EC” declaration of verification that are no more valid;

                        (c)

                        the technical file accompanying the “EC” declaration of verification shall include a demonstration that the impact of modifications is limited to the basic parameters referred to in point (a);

                        (d)

                        provisions of Section 1 of this Annex shall apply mutatis mutandis to this complementary “EC” declaration of verification;

                        (e)

                        the original “EC” declaration of verification shall be considered valid for the basic parameters not concerned by the modification.

                  3.   “EC” DECLARATION OF VERIFICATION OF SUBSYSTEMS IN THE CASE OF ADDITIONAL VERIFICATIONS
            An “EC” declaration of verification of a subsystem may be complemented in the case of additional verifications carried out, in particular when such additional verifications are necessary for an additional authorisation for placing in service. In this case the scope of the complementary declaration shall be limited to the scope of the additional verifications.’

      ANNEX II

            ‘ANNEX VI
            “EC” VERIFICATION PROCEDURE FOR SUBSYSTEMS
            1.   GENERAL PRINCIPLES
            ““EC” verification” means a procedure carried out by the applicant within the meaning of Article 18 to demonstrate that the requirements of the relevant Union legislation including any relevant national rules relating to a subsystem have been fulfilled and the subsystem may be authorised to be placed in service.
            2.   CERTIFICATE OF VERIFICATION ISSUED BY A NOTIFIED BODY
            2.1.   Introduction

            For the purpose of this Directive, the verification by reference to TSIs is the procedure whereby a notified body checks and certifies that the subsystem complies with the relevant technical specifications for interoperability (TSI).
            This is without prejudice of the obligations of the contracting entity or manufacturer (i.e. the applicant in the meaning of Article 18) to comply with the other applicable legislation deriving from the Treaty, including any verifications by the assessment bodies required by the other legislation.
            2.2.   Intermediate statement of verification (ISV)

            2.2.1.   Principles

            At the request of the contracting entity or manufacturer (i.e. the applicant in the meaning of Article 18), the verifications may be done for parts of a subsystem or may be limited to certain stages of the verification procedure. In these cases, the results of verification may be documented in an “intermediate statement of verification” (ISV) issued by the notified body chosen by the contracting entity or manufacturer (i.e. the applicant in the meaning of Article 18).
            The ISV must provide reference to the TSIs with which the conformity has been assessed.
            2.2.2.   Parts of the subsystem

            The applicant within the meaning of Article 18 may apply for an ISV for any part into which he decides to split the subsystem. Each part shall be checked at each stage as set out in point 2.2.3.
            2.2.3.   Stages of the verification procedure

            The subsystem, or certain parts of the subsystem, shall be checked at each of the following stages:

                        (a)

                        overall design,

                        (b)

                        production: construction, including, in particular, civil-engineering activities, manufacturing, constituent assembly and overall adjustment,

                        (c)

                        final testing.

                  The applicant (within the meaning of Article 18) may apply for an ISV for the design stage (including the type tests) and for the production stage for the whole subsystem or for any part into which the applicant decided to split it (see paragraph 2.2.2).
            2.3.   Certificate of verification

            2.3.1.   The notified bodies responsible for the verification assesses the design, production and final testing of the subsystem and draw up the certificate of verification intended for the contracting entity or manufacturer (i.e. the applicant in the meaning of Article 18), who in turn draws up the “EC” declaration of verification. The certificate of verification must provide reference to the TSIs with which the conformity has been assessed.
            Where a subsystem has not been assessed for its conformity with all relevant TSI(s) (e.g. in the case of a derogation, partial application of TSIs for upgrade or renewal, transitional period in a TSI or specific case), the certificate of verification shall give the precise reference to the TSI(s) or their parts whose conformity has not been examined by the notified body during the verification procedure.
            2.3.2.   Where ISV have been issued, the notified body responsible for the verification of the subsystem takes these ISV into account, and, before issuing its certificate of verification:

                        (a)

                        verifies that the ISV cover correctly the relevant requirements of the TSI(s),

                        (b)

                        checks all aspects that are not covered by the ISV, and

                        (c)

                        checks the final testing of the subsystem as a whole.

                  2.3.3.   In the case of a modification to a subsystem already covered by a certificate of verification, the notified body shall perform only those examinations and tests that are relevant and necessary, i.e. assessment shall relate only to the parts of the subsystem that are changed and their interfaces to the unchanged parts of the subsystem.
            2.3.4.   Each notified body involved in the verification of a subsystem shall draw up a technical file in accordance with Article 18(3) covering the scope of its activities.
            2.4.   Technical file accompanying the EC declaration of verification

            The technical file accompanying the EC declaration of verification shall be assembled by the applicant (in the meaning of Article 18) and must contain the following:

                        (a)

                        technical characteristics linked to the design including general and detailed drawings with respect to execution, electrical and hydraulic diagrams, control-circuit diagrams, description of data-processing and automatic systems to the level of detail sufficient for documenting the verification of conformity carried out, documentation on operation and maintenance, etc., relevant for the subsystem concerned;

                        (b)

                        a list of interoperability constituents, referred to in Article 5(3)(d), incorporated into the subsystem;

                        (c)

                        the technical files referred to in Article 18(3), compiled by each of the notified bodies involved in the verification of the sub-system, which shall include:

                                    —

                                    copies of the “EC” declarations of conformity and, where applicable, “EC” declarations of suitability for use established for interoperability constituents referred to in Article 5(3)(d) and accompanied, where appropriate, by the corresponding calculation notes and a copy of the records of the tests and examinations carried out by the notified bodies on the basis of the common technical specifications,

                                    —

                                    where available, the ISV that accompany the certificate of verification, including the result of verification by the notified body of the ISV validity,

                                    —

                                    the certificate of verification, accompanied by corresponding calculation notes and signed by the notified body responsible for the verification, stating that the subsystem complies with the requirements of the relevant TSI(s) and mentioning any reservations recorded during performance of the activities and not withdrawn; the certificate of verification should also be accompanied by the inspection and audit reports drawn up by the same body in connection with its task, as specified in points 2.5.2 and 2.5.3;

                        (d)

                        certificates of verification issued in accordance with other legislation deriving from the Treaty;

                        (e)

                        when verification of safe integration is required pursuant to Article 15, the relevant technical file shall include the assessors' report(s) on the common safety methods (CSM) on risk assessment referred to in Article 6(3) of Directive 2004/49/EC.

                  2.5.   Surveillance by notified bodies

            2.5.1.   The notified body responsible for checking production must have permanent access to building sites, production workshops, storage areas and, where appropriate, prefabrication or testing facilities and, more generally, to all premises which it considers necessary for its task. The notified body must receive from the contracting entity or manufacturers (i.e. the applicant in the meaning of Article 18) all the documents needed for that purpose and, in particular, the implementation plans and technical documentation concerning the subsystem.
            2.5.2.   The notified body responsible for checking implementation must periodically carry out audits in order to confirm compliance with the relevant TSI(s). It must provide those responsible for implementation with an audit report. Its presence may be required at certain stages of the building operations.
            2.5.3.   In addition, the notified body may pay unexpected visits to the worksite or to the production workshops. At the time of such visits the notified body may conduct complete or partial audits. It must provide those responsible for implementation with an inspection report and, if appropriate, an audit report.
            2.5.4.   The notified body shall be able to monitor a subsystem on which an interoperability constituent is mounted in order to assess, where required by the corresponding TSI, its suitability for use in its intended railway environment.
            2.6.   Submission

            A copy of the technical file accompanying the EC declaration of verification must be kept by the manufacturer or contracting entity (i.e. by the applicant in the meaning of Article 18) throughout the service life of the subsystem. It must be sent to any Member State which so requests.
            The documentation submitted for an application for an authorisation for placing in service shall be submitted to the national safety authority of the Member State where the authorisation is sought. The national safety authority may request that part(s) of the documents submitted together with the authorisation is/are translated into its own language.
            2.7.   Publication

            Each notified body must periodically publish relevant information concerning:

                        (a)

                        requests for verification and ISV received,

                        (b)

                        request for assessment of conformity and suitability for use of ICs,

                        (c)

                        ISV issued or refused,

                        (d)

                        certificates of conformity and “EC” certificates for suitability for use issued or refused,

                        (e)

                        certificates of verification issued or refused.

                  2.8.   Language

            The files and correspondence relating to the “EC” verification procedure must be written in a Union official language of the Member State in which the contracting entity or manufacturers (i.e. the applicant in the meaning of Article 18) is established or in a Union official language accepted by the contracting entity or manufacturers (i.e. the applicant in the meaning of Article 18).
            3.   CERTIFICATE OF VERIFICATION ISSUED BY A DESIGNATED BODY
            3.1.   Introduction

            In the case where national rules apply, the verification shall include a procedure whereby the body designated pursuant to Article 17(3), third subparagraph, (the designated body) checks and certifies that the subsystem complies with the national rules notified in accordance with Article 17(3) for each Member State in which the subsystem is intended to be authorised to be placed in service.
            3.2.   Certificate of verification

            The designated body draws up the certificate of verification intended for the contracting entity or manufacturers (i.e. the applicant in the meaning of Article 18).
            The certificate shall contain a precise reference to the national rule(s) whose conformity has been examined by the designated body in the verification process.
            In the case of national rules related to the subsystems composing a vehicle, the designated body shall divide the certificate into two parts, one part including the references to those national rules strictly related to the technical compatibility between the vehicle and the network concerned, and the other part for all other national rules.
            3.3.   Technical file

            The technical file compiled by the designated body and accompanying the certificate of verification in the case of national rules must be included in the technical file accompanying the “EC” declaration of verification referred to in point 2.4 and shall contain the technical data relevant for the assessment of the conformity of the subsystem with those national rules.
            3.4.   Language

            The files and correspondence relating to the “EC” verification procedure must be written in a Union official language of the Member State in which the contracting entity or manufacturers (i.e. the applicant in the meaning of Article 18) is established or in a Union official language accepted by the contracting entity or manufacturers (i.e. the applicant in the meaning of Article 18).
            4.   VERIFICATION OF PARTS OF SUBSYSTEMS IN ACCORDANCE WITH ARTICLE 18(5)
            If a certificate of verification is to be issued for certain parts of a subsystem, provisions for this Annex shall apply mutatis mutandis for those parts.’


Avis juridique important

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32000L0058

Commission Directive 2000/58/EC of 22 September 2000 amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables respectively (Text with EEA relevance)

Official Journal L 244 , 29/09/2000 P. 0078 - 0083

Commission Directive 2000/58/ECof 22 September 2000amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables respectively(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals(1), as last amended by Commission Directive 2000/48/EC(2), and in particular Article 10 thereof,Having regard to Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin(3), as last amended by Commission Directive 2000/42/EC(4), and in particular Article 10 thereof,Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin including fruit and vegetables(5), as last amended by Directive 2000/57/EC(6), and in particular Article 7 thereof,Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(7), as last amended by Commission Directive 2000/10/EC(8), and in particular Article 4(1)(f) thereof,Whereas:(1) The new active substance, kresoxim-methyl, was included in Annex I to Directive 91/414/EEC by Commission Directive 1999/1/EC(9) for use as fungicide only, without specifying particular conditions having an impact on crops which may be treated with plant protection products containing kresoxim methyl.(2) The said inclusion in Annex I was based on assessment of the information submitted concerning proposed use as fungicide on cereals, pome fruit and vines. Information relating to other uses has been submitted by certain Member States in accordance with the requirements of Article 4(1)(f) of Directive 91/414/EEC. The information available has been reviewed and is sufficient to fix certain maximum residue levels.(3) Where no Community maximum residue level or provisional MRL exists Member States shall establish a national provisional maximum residue level in accordance with Article 4(1)(f) of Directive 91/414/EEC. The information available has been reviewed and is sufficient to fix certain maximum residue levels.(4) At the inclusion in Annex I to Directive 91/414/EEC, the technical and scientific evaluation of kresoxim methyl was finalised on 16 October 1998 in the format of the Commission review report for kresoxim methyl. In this review report the acceptable daily intake (ADI) for kresoxim methyl was set at 0,4 mg/kg of body weight. The lifetime exposure of consumers of food products treated with kresoxim methyl has been assessed and evaluated in accordance with the procedures and practices used within the European Community, taking account of guidelines published by the World Health Organisation(10) and it has been calculated that the maximum residue levels fixed in this Directive do not give rise to an exceeding of this ADI.(5) Acute toxic effects requiring the setting of an acute reference dose were not noted during the evaluation and discussion that preceded the inclusion of kresoxim methyl in Annex I to Directive 91/414/EEC.(6) For certain agricultural products the use conditions for kresoxim methyl were already defined in a manner which permits the establishing of definitive maximum residue levels.(7) To ensure that the consumer is adequately protected from exposure to residues in or on products for which no authorisations have been granted, it is prudent to set provisional maximum residue levels at the lower limit of analytical determination for all those products covered by Directives 86/362/EEC, 86/363/EEC and 90/642/EEC. The setting at Community level of such provisional maximum residue levels does not prevent the Member States from establishing provisional maximum residue levels for kresoxim methyl in accordance with Article 4(1)(f) of Directive 91/414/EEC and in accordance with Annex VI to Directive 91/414/EEC in particular Part B, Section 2.4.2.3 to this Annex. Four years is considered a sufficient period of time during which to establish most further uses of kresoxim methyl. After that period these provisional maximum residue levels should become definitive;(8) The Community's trading partners have been consulted aobut the levels set out in this Directive through the World Trade Organisation and their comments on these levels have been considered. The possibility of fixing import tolerance maximum residue levels for specific pesticide/crop combinations will be examined by the Commission on the basis of the submission of acceptable data.(9) The opinions of the Scientific Committee for Plants, in particular advice and recommendations concerning the protection of consumers of food products treated with pesticides, have been taken into account.(10) This Directive is in accordance with the opinion of the Standing Committee on Plant Health,HAS ADOPTED THIS DIRECTIVE:Article 1The following is added to Part A of Annex II to Directive 86/362/EEC:">TABLE>"Article 2The following is added to Part of Annex II to Directive 86/363/EEC:">TABLE>"Article 3The maximum residue levels for kresoxim methyl in the Annex to this Directive are added to Annex II to Directive 90/642/EEC.Article 41. Where the maximum residue levels for kresoxim methyl are indicated as "(p)", this means that they are provisional (p) in accordance with the provisions of Article 4(1)(f) of Directive 91/414/EEC.2. Four years after the entry into force of this Directive, provisional maximum residue levels for kresoxim methyl in the Annexes cease to be provisional and become definitive in the sense of Article 4(1) of Directives 86/362/EEC and 86/363/EEC or Article 3 of Directive 90/642/EEC respectively.Article 5This Directive enters into force on the 20th day following its publication in the Official Journal of the European Communities.Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 March 2001 at the latest. They shall forthwith inform the Commission thereof.They shall apply these provisions as of 1 April 2001.When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.Article 6This Directive is addressed to the Member States.Done at Brussels, 22 September 2000.For the CommissionDavid ByrneMember of the Commission(1) OJ L 221, 7.8.1986, p. 37.(2) OJ L 197, 3.8.2000, p. 26.(3) OJ L 221, 7.8.1986, p. 43.(4) OJ L 158, 30.6.2000, p. 51.(5) OJ L 350, 14.12.1990, p. 71.(6) See page 76 of this Official Journal.(7) OJ L 230, 19.8.1991, p. 1.(8) OJ L 57, 2.3.2000, p. 28.(9) OJ L 21, 28.1.1999, p. 21.(10) Guidelines for predicting dietary intake of pesticide residues (revised), prepared by the GEMS/Food Programme in collaboration with the Codex Committee on pesticide residues, published by the World Health Organsiation 1997 (WHO/FSF/FOS/97.7).ANNEX>TABLE>