Avis juridique important

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32000L0037

Commission Directive 2000/37/EC of 5 June 2000 amending Chapter VIa 'Pharmacovigilance' of Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products (Text with EEA relevance)

Official Journal L 139 , 10/06/2000 P. 0025 - 0027

Commission Directive 2000/37/ECof 5 June 2000amending Chapter VIa "Pharmacovigilance" of Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 81/851/EEC of 28 September 1981 on the appriximation of the laws of the Member States relating to veterinary medicinal products(1), as last amended by Directive 93/40/EEC(2), and in particular Article 42i thereof;Whereas:(1) In order to ensure the continued safety of veterinary medicinal products in use, it is necessary to ensure that pharmacovigilance systems in the Community are continually adapted to take account of scientific and technical progress.(2) For public health protection, relevant data on adverse effects in humans related to the use of veterinary medicines should be collected and evaluated.(3) The pharmacovigilance systems should consider the available data on lack of efficacy.(4) In addition, collection of information on adverse reactions due to off-label use, investigations of the validity of the withdrawal period and on potential environmental problems may contribute to improve regular monitoring of good usage of veterinary medicines.(5) It is necessary to take account of changes arising as a result of international harmonisation of definitions, terminology and technological developments in the field of pharmacovigilance.(6) The increasing use of the mutual recognition procedure established by Directive 81/851/EEC requires that current procedures for reporting and dissemination of suspected adverse reactions be amended to ensure better co-ordination between Member States.(7) The increasing use of electronic means of communication of information on adverse reactions to veterinary medicinal products marketed in the Community is intended to allow a single reporting point for adverse reactions, at the same time ensuring that this information is shared with the competent authorities in all Member States.(8) It is necessary to further define terms currently used within the veterinary pharmacovigilance systems.(9) It is the interest of the Community to ensure that the veterinary pharmacovigilance systems for centrally authorised medicinal products and those authorised by other procedures are consistent.(10) Holders of marketing authorisations should additionally be proactively responsible for ongoing pharmacovigilance of the veterinary medicinal products they place on the market.(11) The measures provided for in this Directive are in conformity with the opinion of the Standing Committee on veterinary medicinal products,HAS ADOPTED THIS DIRECTIVE:Article 1Chapter VIa "Pharmacovigilance" of Directive 81/851/EEC is hereby amended as follows:1. Article 42a, is hereby replaced by the following text:"Article 42aIn order to ensure the adoption of appropriate regulatory decisions concerning the veterinary medicinal products authorised within the Community, having regard to information obtained about suspected adverse reactions to veterinary medicinal products under normal conditions of use, the Member States shall establish a veterinary pharmacovigilance system. This system shall be used to collect information useful in the surveillance of veterinary medicinal products, with particular reference to a dverse reactions in animals and in human beings related to the use of veterinary medicinal products, and to evaluate such information scientifically.Such information shall be collated with available data on the sale and prescription of veterinary medicinal products.This system also takes into account any available information related to the lack of expected efficacy, off-label use, investigations of the validity of the withrawal period and on potential environmental problems, arising from the use of the product, interpreted in accordance with the Commission guidelines referred to in Article 42g, which may have an impact on the evaluation of their benefits and risks."2. Article 42b, is hereby replaced by the following:"Article 42bFor the purpose of this Directive, the following definitions shall apply:(a) 'adverse reaction' means a reaction which is harmful and unintended and which occurs at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or the modification of physiological function,(b) 'human adverse reaction' means a reaction which is noxious and unintended and which occurs in a human being following exposure to a veterinary medicine,(c) 'serious adverse reaction' means an adverse reaction which results in death, is life-threatening, results in significant disability or incapacity, is a congenital anomaly/birth defect, or which results in permanent or prolonged signs in the animals treated;(d) 'unexpected adverse reaction' means an adverse reaction, the nature, severity or outcome of which is not consistent with the summary of the product characteristics,(e) 'periodic safety update reports' means the periodical reports containing the records referred to in Article 42d;(f) 'post-marketing surveillance studies' means pharmacoepidemiological study or a clinical trial carried out in accordance with the terms of the marketing authorisation, conducted with the aim of identifying and investigating a safety hazard relating to an authorised veterinary medicinal product,(g) 'off-label use' means the use of a veterinary medicinal product that is not in accordance with the summary of the product characteristics, including the misuse and serious abuse of the product.For the interpretation of the definitions and principles outlined in this chapter, the marketing authorisation holder and the competent authorities shall refer to the detailed guidance referred to in Article 42g."3. Article 42c is hereby amended as follows:(a) in the first paragraph, the words "person responsible for placing the veterinary medicinal product on the market" are changed to "marketing authorisation holder";(b) in point (a) of the second paragraph, the words "at a single point" are changed to "in order to be accessible at least at one point within the Community";(c) in point (b) of the second paragraph the words "relevant national or Community guidance" are changed to "guidance referred to in Article 42g";(d) to the second paragraph the following point (d) is added:"d) the provision to the competent authorities, of any other information relevant to the evaluation of the benefits and risks afforded by a veterinary medicinal product, including appropriate information on post-marketing surveillance studies."4. Article 42d, is hereby replaced by the following text:"Article 42d1. The marketing authorisation holder shall be required to maintain detailed records of all suspected adverse reactions occurring either in the Community or in a third country.2. The marketing authorisation holder shall be required to record and to report all suspected serious adverse reactions and human adverse reactions related to the use of veterinary medicinal products, of which he can reasonably be expected to have knowledge, or which are brought to his attention, immediately to the competent authority of the Member State in whose territory the incident occured, and in no case later than 15 calendar days following the receipt of the information.3. The marketing authorisation holder shall ensure that the suspected serious and unexpected adverse reactions and human adverse reactions, occuring in the territory of a third country, are reported immediately in accordance with the guidance referred to in Article 42g, so that they are available to the Agency and to the competent authorities in the Member State(s) where the veterinary medicinal product is authorised, and in no case later than 15 calendar days following the receipt of the information.4. In the case of veterinary medicinal products which have been considered within the scope of Directive 87/22/EEC, or which have benefited from the procedures of mutual recognition under Articles 8, 8a and 17(4) and veterinary medicinal products for which there has been a referral to the procedures under Articles 21 and 22 of this Directive, the marketing authorisation holder shall additionally ensure that all suspected serious adverse reactions and human adverse reactions, occurring in the Community, are reported in the format and at intervals to be agreed with the reference Member State or a a competent authority designated as reference Member State, in such a way so as to be accessible to the reference Member State.5. Unless other requirements have been laid down as condition of the granting of authorisation, records of all adverse reactions shall be submitted to the competent authorities in the form of a periodic safety update report, either immediately upon request or periodically as follows: six monthly for the first two years after authorisation, annually for the subsequent two years, and at the time of the first renewal. Thereafter, the periodic safety update reports shall be submitted at five-yearly intervals together with the application for renewal of the authorisation. The periodic safety update report shall include a scientific evaluation of the benefit and risks afforded by the veterinary medicinal product.6. Following the granting of a marketing authorisation, the marketing authorisation holder may request the amendment of the periods referred to in this Article according to the procedure laid down by the Commission Regulation (EC) No 541/95(3), if applicable."5. A new second paragraph is added to Article 42e:"The Member States may impose specific requirements on veterinary practitioners and other health care professionals in respect of the reporting of suspected serious or unexpected adverse reactions and human adverse reactions, in particular where such reporting is a condition of the marketing authorisation."6. Article 42f, is replaced by the following text:"Article 42f1. The Agency, in collaboration with the Member States and the Commission shall set up a data-processing network to facilitate the exchange of pharmacovigilance information regarding medicinal products marked in the Community.2. Making use of the network foreseen in the first paragraph, Member States shall ensure that reports of suspected serious adverse reactions and human adverse reactions, in accordance with the Standing Committee on veterinary medicinal products guidance referred to in Article 42g, that have taken place on their territory are immediately made available to the Agency and the other Member States, and in any case within 15 calendar days of their notification, at the latest.3. The Member States shall ensure that reports of suspected serious adverse reactions and human adverse reactions, that have taken place on their territory are immediately made available to the marketing authoriation holder, and in any case within 15 calendar days of their notification, at the latest."7. Article 42g is amended as follows:"Article 42g(a) In order to facilitate the exchange of information about pharmocovigilance within the Community, the Commission, in consultation with the Agency, Member States and the interested parties, shall draw up guidance on the collection, verification and presentation of adverse reaction reports, including technical requirements for electronic exchange of veterinary pharmacovigilance information in accordance with internationally agreed terminology.(b) This guidance shall be published in Volume 9 of the Rules governing medicinal products in the European Union and shall take account of international harmonisation work carried out in the field of pharmacovigilance."8. Article 42h is replaced by the following text:"Article 42hWhere, as a result of the evaluation of veterinary pharmacovigilance data, a Member State considers that a marketing authorisation should be suspended, withdrawn or varied to restrict the indications or availability, amend the posology, add a contraindication or add a new precautionary measure, it shall forthwith inform the Agency, the other Member States and the marketing authorisation holder.In case of urgency, the Member State concerned may suspend the marketing authorisation of a veterinary medicinal product, provided the Agency, the Commission and the other Member States are informed at the latest on the following working day."Article 2Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 5 December 2001.When the Member States adopt the provisions set out in paragraph 1, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such references shall be adopted by the Member States. The Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive.Article 3This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.Article 4This Directive is addressed to the Member States.Done at Brussels, 5 June 2000.For the CommissionErkki LiikanenMember of the Commission(1) OJ L 317, 6.11.1981, p. 1.(2) OJ L 214, 24.8.1993, p. 31.(3) OJ L 55, 11.3.1995, p. 7.


title: Commission Directive 2010/62/EU of 8 September 2010 amending, for the purpose of adapting their technical provisions, Council Directives 80/720/EEC and 86/297/EEC and Directives 2003/37/EC, 2009/60/EC and 2009/144/EC of the European Parliament and of the Council relating to the type-approval of agricultural or forestry tractors  Text with EEA relevance

text:
               9.9.2010

               EN

               Official Journal of the European Union

               L 238/7

         COMMISSION DIRECTIVE 2010/62/EU
   of 8 September 2010
   amending, for the purpose of adapting their technical provisions, Council Directives 80/720/EEC and 86/297/EEC and Directives 2003/37/EC, 2009/60/EC and 2009/144/EC of the European Parliament and of the Council relating to the type-approval of agricultural or forestry tractors
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2003/37/EC of the European Parliament and of the Council of 26 May 2003 on type-approval of agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units and repealing Directive 74/150/EEC (1), and in particular points (a) and (b) of Article 19(1) thereof,
   Whereas:

               (1)

               Technical progress allows for complete whole vehicle type-approval for tractors of category T4.3 (low-clearance tractors), as defined in Directive 2003/37/EC. Therefore, Council Directive 80/720/EEC of 24 June 1980 on the approximation of the laws of the Member States relating to the operating space, access to the driving position and the doors and windows of wheeled agricultural or forestry tractors (2), Directive 2003/37/EC, Directive 2009/60/EC of the European Parliament and of the Council of 13 July 2009 on the maximum design speed of and load platforms for wheeled agricultural or forestry tractors (3) and Directive 2009/144/EC of the European Parliament and of the Council of 30 November 2009 on certain components and characteristics of wheeled agricultural or forestry tractors (4) should be amended to take account of the specificities of low-clearance tractors.

               (2)

               In order to progress in the completion of the internal market and to achieve higher levels of occupational safety, requirements for front power take-offs for all tractor categories covered by Directive 2003/37/EC should be included in Council Directive 86/297/EEC of 26 May 1986 on the approximation of the laws of the Member States relating to the power take-offs of wheeled agricultural and forestry tractors and their protection (5).

               (3)

               The required clearance zones and dimensions of the power take-off protective guard established in Directive 86/297/EEC should be amended in order to achieve worldwide harmonisation of such zones and dimensions so as to facilitate the global competitiveness of Union manufacturers.

               (4)

               ISO 500-1:2004 together with the Technical Corrigendum 1:2005, ISO 500-2:2004, and ISO 8759-1:1998 contain globally recognised requirements for power take-offs of all tractors covered by Directive 2003/37/EC. It is therefore appropriate to make reference to those ISO standards in Directive 86/297/EEC.

               (5)

               Directive 2003/37/EC should be amended in order to reflect the application of Directive 86/297/EEC to tractors of category T5. Equally, Directive 2003/37/EC should be amended to reflect the application of Directive 2009/60/EC and Directive 80/720/EEC to tractors of category T4.3.

               (6)

               The measures provided for in this Directive are in accordance with the opinion of the Committee established in Article 20(1) of Directive 2003/37/EC,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Directive 80/720/EEC is amended as follows:

               1.

               Article 1 is replaced by the following:
               ‘Article 1
               1.   For the purposes of this Directive, “tractor” means a tractor as defined in Article 2(j) of Directive 2003/37/EC of the European Parliament and of the Council (6),
               For the purposes of this Directive, the tractor categories defined in Annex II to Directive 2003/37/EC shall apply.
               2.   This Directive shall apply to tractor categories T1, T3 and T4 as defined in Annex II to Directive 2003/37/EC.
               This Directive shall not apply to tractors of category T4.3 where the driver’s seat index point, as determined in Annex II to Directive 2009/144/EC of the European Parliament and of the Council (7) is more than 100 mm from the median longitudinal plane of the tractor.

               2.

               Annex I is amended in accordance with Annex I to this Directive.

         Article 2
   Directive 86/297/EEC is amended as follows:

               1.

               The title is replaced by the following:

               2.

               Article 1 is replaced by the following:
               ‘Article 1
               1.   For the purposes of this Directive, “tractor” means a tractor as defined in Article 2(j) of Directive 2003/37/EC of the European Parliament and of the Council (8).
               2.   For the purposes of this Directive, the tractor categories defined in Annex II to Directive 2003/37/EC shall apply.

               3.

               Annexes I and II are replaced by the text set out in Annex II to this Directive.

         Article 3
   Annex II to Directive 2003/37/EC is amended in accordance with Annex III to this Directive.
   Article 4
   Directive 2009/60/EC is amended as follows:

               1.

               Article 1 is replaced by the following:
               ‘Article 1
               1.   For the purposes of this Directive, “tractor” means a tractor as defined in Article 2(j) of Directive 2003/37/EC.
               2.   For the purposes of this Directive, the tractor categories defined in Annex II to Directive 2003/37/EC shall apply.
               3.   This Directive shall apply only to tractors which are equipped with pneumatic tyres and have a maximum design speed of not more than 40 km/h.’;

               2.

               Annex I is amended in accordance with Annex IV to this Directive.

         Article 5
   Directive 2009/144/EC is amended as follows:

               1.

               Article 1 is replaced by the following:
               ‘Article 1
               1.   For the purposes of this Directive, “tractor” means a tractor as defined in Article 2(j) of Directive 2003/37/EC.
               2.   For the purposes of this Directive, the tractor categories defined in Annex II to Directive 2003/37/EC shall apply.
               3.   This Directive shall apply to tractor categories T1, T2, T3 and T4.’;

               2.

               Annex II is amended in accordance with Annex V to this Directive.

         Article 6
   1.   For tractor categories T1, T2 and T3 as defined in Annex II to Directive 2003/37/EC, Member States shall apply the provisions referred to in Article 7(1) of this Directive to new types of vehicles from 29 September 2011 and to new vehicles from 29 September 2012.
   2.   For tractors of category T4.3 as defined in Annex II to Directive 2003/37/EC, Member States shall apply the provisions referred to in Article 7(1) of this Directive to new types of vehicles from 29 September 2013 and to new vehicles from 29 September 2016.
   3.   For vehicle categories T4.1, T4.2, T5, C, R and S as defined in Annex II to Directive 2003/37/EC, Member States shall apply the provisions referred to in Article 7(1) of this Directive to new types of vehicles and to new vehicles from the dates laid down in Article 23(2) of Directive 2003/37/EC.
   Article 7
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 29 September 2011 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   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.
   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 8
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 9
   This Directive is addressed to the Member States.

      Done at Brussels, 8 September 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 171, 9.7.2003, p. 1.

      (2)  OJ L 194, 28.7.1980, p. 1.

      (3)  OJ L 198, 30.7.2009, p. 15.

      (4)  OJ L 27, 30.1.2010, p. 33.

      (5)  OJ L 186, 8.7.1986, p. 19.

      (6)  OJ L 171, 9.7.2003, p. 1.

      (7)  OJ L 27, 30.1.2010, p. 33.’;

      (8)  OJ L 171, 9.7.2003, p. 1.’;

      ANNEX I
      Point I.2 of Annex I to Directive 80/720/EEC is replaced by the following:

                     ‘I.2.

                     For all tractors with the exception of narrow tractors with track width ≤ 1 150 mm and those that fall within category T4.3, the width of the operating space must be at least 900 mm, from 400 to 900 mm above the reference point and over a length of 450 mm forward of that point (see Figures 1 and 3).
                     For tractors of category T4.3, the operating space must, over the zone extending to 450 mm in front of the reference point, have at a height of 400 mm above the reference point, a total width of at least 700 mm, and at a height of 900 mm above the reference point, a total width of at least 600 mm.’

      ANNEX II
      ‘
            ANNEX I

               General provisions and requirements for power take-offs

            1.   Definition and scope
            1.1.   “Power take-off” (PTO) means an external shaft of the tractor to provide rotational power to implements.
            1.2.   The provisions of this Directive apply only to power take-offs as defined in point 1.1 and located at the rear or the front of the tractor.
            2.   Application for EC type-approval
            2.1.   The application for the type approval of a tractor type as regards the power take-off and its protection must be submitted by the tractor manufacturer or his authorised representative, using the information document, the model of which appears in Annex II, Part 1.
            2.2.   It must be accompanied by drawings, in triplicate, on an appropriate and suitably detailed scale, of those parts of the tractor subject to the requirements of this Directive.
            2.3.   A tractor representative of the type submitted for approval or those part(s) of the tractor considered essential for the execution of the tests required by this Directive must be supplied to the technical service responsible for conducting the type-approval tests.
            3.   EC type-approval certificate
            A certificate conforming to the model which appears in Annex II, Part 2 must be completed for each approval granted or refused.
            4.   General Provisions
            Where tractors are equipped with power take-offs, these must comply with the requirements of this Annex.
            For the purposes of this Directive, the standards referred to in points 4.1 and 4.2 apply.
            4.1.   Provisions for rear power take-offs
            The specifications of ISO 500-1:2004 together with Technical Corrigendum 1:2005 and ISO 500-2:2004 apply to tractors with rear power take-offs according to Table 1.

               Table 1

               Application of standards for rear power take-offs of the different tractor categories

                        Standard applicable

                        T1
                        C1

                        T2
                        C2

                        T3
                        C3

                        T4.1
                        C4.1

                        T4.2
                        C4.2

                        T4.3
                        C4.3

                        T5
                        C5

                        ISO 500-1:2004 (1)
                            (3)

                        X

                        --

                        X1)

                        X1)

                        X1)

                        X

                        X1)

                        ISO 500-2:2004 (2)

                        --

                        X

                        X2)

                        X2)

                        X2)

                        --

                        X2)

                                    X

                                    Standard applicable.

                                    --

                                    Standard not applicable.

                                    X1)

                                    Standard applicable for tractors with a track width of more than 1 150 mm.

                                    X2)

                                    Standard applicable for tractors with a track width of 1 150 mm or less.

                  4.2.   Provisions for front power take-offs
            The specifications of ISO 8759-1:1998 apply to tractors with front power take-offs according to Table 2.

               Table 2

               Application of standards for front power take-offs of the different tractor categories

                        Standard applicable

                        T1
                        C1

                        T2
                        C2

                        T3
                        C3

                        T4.1
                        C4.1

                        T4.2
                        C4.2

                        T4.3
                        C4.3

                        T5
                        C5

                        ISO 8759-1:1998

                        X

                        X

                        X3)

                        X4)

                        X

                        X4)

                        X

                                    X

                                    Standard applicable.

                                    X3)

                                    Standard applicable when the tractor is equipped with power take-offs as specified in this standard.

                                    X4)

                                    Standard applicable, except clause 4.2.

            ANNEX II

               Part 1

            INFORMATION DOCUMENT No […]
            pursuant to Annex I to Directive 2003/37/EC relating to EC type-approval of a tractor with respect to the power take-offs of tractors
            The following information, if applicable, shall be supplied in triplicate and include a list of contents.
            Any drawings shall be supplied in appropriate scale and in sufficient detail in A4 format. Photographs, if any, shall show sufficient detail.
            0.   GENERAL

                        0.1.

                        Make(s) (trade mark registered by the manufacturer):

                        0.2.

                        Type (specify any variants and versions):

                        0.3.

                        Means of identification of type, if marked on the vehicle:

                                    0.3.1.

                                    Manufacturer’s plate (location and method of affixing):

                        0.4.

                        Category of vehicle (4):

                        0.5.

                        Name and address of manufacturer:

                        0.8.

                        Name(s) and address(es) of assembly plant(s):

                        4.12.

                        Power take-off(s) (revolutions per minute and ratio of this figure to that of the engine) (number, type and position)

                                    4.12.1.

                                    Main power take-off(s):

                                    4.12.2.

                                    Other(s):

                                    4.12.3.

                                    Power take-off guard(s) (description, dimensions, drawings, photographs):

               Part 2

            TYPE-APPROVAL DOCUMENTATION
            MODEL

               (maximum format: A4 (210 × 297 mm))

            EC TYPE-APPROVAL CERTIFICATE

            Communication concerning the

                        —

                        type approval (5)

                        —

                        extension of type approval (5)

                        —

                        refusal of type approval (5)

                        —

                        withdrawal of type approval (5)

                  of a type of tractor with regard to Directive 86/297/EEC,
            Type-approval number: …
            Reason for extension: …

               Section I

                        0.1.

                        Make (trade name of manufacturer):

                        0.2.

                        Tractor type:

                        0.3.

                        Means of identification of tractor type if marked on the tractor (6):

                        0.3.1.

                        Location of that marking:

                        0.4.

                        Category of vehicle (7):

                        0.5.

                        Name and address of manufacturer:

                        0.8.

                        Name(s) and address(es) of assembly plant(s):

               Section II

                        1.

                        Additional information (where applicable): See Addendum

                        2.

                        Technical service responsible for carrying out the tests:

                        3.

                        Date of test report:

                        4.

                        Number of test report:

                        5.

                        Remarks (if any): See Addendum

                        6.

                        Place:

                        7.

                        Date:

                        8.

                        Signature:

                        9.

                        The index to the information package lodged with the approval authority, which may be obtained on request, is attached.

                  ’

         (1)  In the standard ISO 500-1:2004, the last sentence in section 6.2 is not applicable.

         (2)  For the purposes of this Directive, this standard also applies to tractors with a power take-off, the power of which exceeds 20 kW, measured in accordance with ISO 789-1:1990.

         (3)  For power take-offs of type 3 and where it is possible to reduce the dimension of the opening of the protective guard in order to adapt to the coupling elements to be used, the user manual must contain the following elements:

                  —

                  warning relating to the consequences and risks caused by the reduced dimension of the protective guard,

                  —

                  instructions and specific warnings relating to coupling and releasing the power take-offs,

                  —

                  instructions and specific warnings relating to the use of tools or machines coupled to the rear power take-off.

         (4)  As defined in Annex II to Directive 2003/37/EC.

         (5)  Delete where not applicable.

         (6)  Where the means of identification of tractor type contains characters not relevant to describe the tractor types covered by this type-approval certificate, such characters are represented in the documentation by the symbol “?” (e.g. ABC?123?).

         (7)  As defined in Annex II to Directive 2003/37/EC.

      ANNEX III
      Annex II to Directive 2003/37/EC is amended as follows:

                  1.

                  in Chapter B, Part I, in the List of separate directives, in line 18.1, column T5, the figure ‘(X)’ is replaced by the figure ‘X’;

                  2.

                  Chapter B, Appendix 1, Part II is amended as follows:

                              (a)

                              in line 2.2, column T4.3, the figure ‘(X)’ is replaced by the figure ‘X’;

                              (b)

                              in line 17.1, column T4.3, the figure ‘(X)’ is replaced by the figure ‘X’.

      ANNEX IV
      The following subparagraph is added to point 2.2 of Annex I to Directive 2009/60/EC:

         ‘In the case of tractors of category T4.3, the length of the platform shall not exceed 2,5 times the maximum front or rear track of the tractor, whichever is the larger.’

      ANNEX V
      Annex II to Directive 2009/144/EC is amended as follows:

                  1.

                  point 2.3.2.11 is replaced by the following:

                              ‘2.3.2.11.

                              Narrow-track tractors and tractors of category T4.3.’

                  2.

                  point 2.3.2.11.1 is replaced by the following:

                              ‘2.3.2.11.1.

                              In the case of narrow-track tractors as defined in the second indent of Article 1 of Council Directive 87/402/EEC (1) and tractors of category T4.3 as defined in Annex II, Chapter B, Appendix 1, Part I, of Directive 2003/37/EC the requirements of point 2.3.2.9 shall not apply to the zone situated below a plane inclined at 45° to the rear and transverse to the direction of travel, and passing through a point located 230 mm behind the seat index point (see Figure 7). If there are any dangerous points in this zone, corresponding warnings must be affixed to the tractor.

         (1)  OJ L 220, 8.8.1987, p. 1.’


Avis juridique important

|

31978L0050

Council Directive 78/50/EEC of 13 December 1977 supplementing, as regards the chilling process, Directive 71/118/EEC on health problems affecting trade in fresh poultrymeat

Official Journal L 015 , 19/01/1978 P. 0028 - 0031 Finnish special edition: Chapter 3 Volume 9 P. 0146  Greek special edition: Chapter 03 Volume 19 P. 0231  Swedish special edition: Chapter 3 Volume 9 P. 0146  Spanish special edition: Chapter 03 Volume 13 P. 0171  Portuguese special edition Chapter 03 Volume 13 P. 0171

COUNCIL DIRECTIVE  of 13 December 1977  supplementing, as regards the chilling process, Directive 71/118/EEC on health problems affecting trade in fresh poultrymeat  (78/50/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the the Treaty establishing the European Economic Community, and in particular Articles 43 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 Article 14 of Council Directive 71/118/EEC of 15 February 1971 on health problems affecting trade in fresh poultrymeat (3), as last amended by Directive 75/431/EEC (4), stipulates that the Member States shall prohibit the use of the process for chilling poultry referred to in the said Article;  Whereas such prohibition will not be binding until 18 months after the Commission has submitted a report on chilling processes which are not covered by the prohibition or until 1 January 1978 at the latest;  Whereas the Commission, after consulting the Member States within the Standing Veterinary Committee, submitted to the Council a report laying down the conditions governing plant, operation and control which the process of chilling by immersion in water must meet in order not to be considered as falling within the scope of the said prohibition ; whereas this Directive is based on the conclusions of that report,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Article 14 of Directive 71/118/EEC shall be replaced by the following text:  "Article 14   1. As from 15 February 1979 Member States shall prohibit the chilling of fresh poultrymeat by means of immersion in water, unless it is effected in accordance with the conditions laid down in points 28a and 28b of Chapter V of Annex I and the carcases thus chilled are immediately frozen or deep-frozen.   2. However, in the case of carcases obtained and intended for marketing in their territory, Member States shall be authorized to grant, on request, to undertakings carrying on their activity in their territory on 1 January 1978 derogations from the requirements of paragraph 1. Such derogations may not extend beyond 15 August 1982.  Member States making use of the derogations provided for in the first paragraph may not object to the introduction into their territory of poultrymeat obtained in another Member State under the same conditions.  (1)OJ No C 293, 13.12.1976, p. 70. (2)OJ No C 56, 7.3.1977, p. 88. (3)OJ No L 55, 8.3.1971, p. 23. (4)OJ No L 192, 24.7.1975, p. 6.     3. Member States wishing to make use of the possibility afforded by paragraph 2 shall inform the Commission and the other Member States as soon as possible and in any case not later than 15 February 1979.   4. Where the derogation clauses in paragraph 2 are invoked, use of the health marking provided for in Annex I, Chapter X, shall be prohibited.  However, for the implementation of the second subparagraph of paragraph 2, the Member States concerned shall be authorized to allow into their territory carcases which do not bear any health mark as provided for in Annex I, Chapter X."   Article 2 The following Article shall be incorporated in Directive 71/118/EEC:  "Article 14a  1. The Commission, after consulting the Member States in the Standing Veterinary Committee, shall submit to the Council by 1 January 1980 a report, possibly accompanied by or followed by appropriate proposals on:      (a) continuation of the study on processes for the chilling of carcases which are satisfactory from the point of view of hygiene, the report dealing both with the development of the system referred to in Annex I, Chapter V, points 28a and 28b and with other chilling processes, particularly those using liquid CO2 and liquid nitrogen or the process by means of spraying;           (b) microbiological checks - including the role of limit values - and the microbiological methods to be employed for the purposes of such checks, on:        (i) the degree of hygiene of the immersion chilling process referred to in Annex I, Chapter V, points 28a and 28b ; and               (ii) the whole slaughtering process from the time the live bird enters the slaughterhouse until the packaging stage or, where appropriate, until the carcase leaves the slaughterhouse;                          (c) water uptake - including evaluation of the role of its limit value - as a parameter for hygiene checks on immersion chilling equipment.              2. The Commission, after consulting the Member States in the Standing Veterinary Committee, shall submit to the Council by 15 October 1978 a report possibly accompanied by proposals on the specific conditions of hygiene under which the process which complies with the conditions laid down in points 28a and 28b of Annex I, Chapter V, may be applied to carcases which are neither immediately frozen nor deep-frozen.   3. The Council shall act unanimously on the Commission proposals referred to in paragraph 1 within a period of 12 months from the date of their submission and before 31 December 1978 on the proposals referred to in paragraph 2."   Article 3 The following points shall be added to Chapter V of Annex I to Directive 71/118/EEC:  "28a. Carcases to be subjected to an immersion chilling process in accordance with the process described in 28b must, immediately after evisceration, be thoroughly washed by spraying and immersed without delay. The spraying must be carried out by means of equipment which washes both the internal and external surfaces of the carcases efficiently.  For carcases weighing:    - not more than 2 75 kilograms, at least 1 75 litres of water must be used per carcase,       - between 2 75 kilograms and 5 kilograms, at least 2 75 litres of water must be used per carcase,       - 5 kilograms or more, at least 3 75 litres of water must be used per carcase.         28b. The immersion chilling process shall meet the following requirements:    (a) the carcases must pass through one or more tanks of water or of ice and water the contents of which are continuously renewed. Only the system whereby the carcases are constantly propelled by mechanical means through a counterflow of water is acceptable;       (b) the temperature of the water in the tank or tanks measured at the points of entry and exit of the carcases must not be more than + 16 ºC and + 4 ºC respectively;       (c) it must be carried out in such a way that the temperature specified in Chapter XII is reached in the shortest possible time;        (d) the minimum flow of water throughout the whole chilling process referred to in paragraph (a) must be      - 2 75 litres per carcase weighing 2 75 kilograms or less,           - 4 litres per carcase weighing between 2 75 kilograms and 5 kilograms,           - 6 litres per carcase weighing 5 kilograms or more.             If there are several tanks, the inflow of fresh water and the outflow of used water in each tank must be regulated in such a way as to progressively decrease in the direction of movement of the carcases, the fresh water being divided between the tanks in such a way that the flow of water through the last tank is not less than:      - 1 litre per carcase weighing 2 75 kilograms or less,           - 1 75 litres per carcase weighing between 2 75 kilograms and 5 kilograms,           - 2 litres per carcase weighing 5 kilograms or more.             The water used for first filling the tanks must not be included in the calculation of these quantities;       (e) the carcases must not remain in the first part of the apparatus or the first tank for more than half an hour or in the rest of the apparatus or the other tank(s) for longer than strictly necessary.  All necessary precautions must be taken to ensure that, in the event of interruptions of the process, the transit time laid down in the first subparagraph is complied with.  Whenever the equipment stops, the official veterinarian must satisfy himself that prior to the re-setting in motion the carcases still conform to the requirements of the Directive and are fit for human consumption or, if such is not the case, ensure that they are transported as soon as possible to the premises provided for in point 1 (h) and (i);       (f) each piece of equipment must be entirely emptied, cleaned and disinfected whenever this is necessary at the end of the period of work and at least once a day;       (g) it must be provided with calibrated control equipment to permit adequate and continued supervision of the measuring and recording of:      - the water consumption during spray-washing before immersion,           - the temperature of the water in the tank or tanks at the points of entrance and exit of the carcases,           - the water consumption during immersion,           - the number of carcases in each of the weight-ranges listed in (d) above and in point 28a;                  (h) the results of the various checks carried out by the producer must be kept and submitted on request to the official veterinarian;       (i) the correct functioning of the chilling plant and its effect on the hygiene level shall be evaluated - pending adoption, in accordance with Article 14a, of Community microbiological methods - by scientific microbiological methods recognized by the Member States, the contamination of the carcases with total and enterobacteriacea bacteria being compared before and after immersion. Such comparison must be carried out when the plant is first brought into use and after that periodically and in any case each time any alterations are made to the plant. The functioning of the various parts must be regulated so as to ensure a satisfactory standard of hygiene."          Article 4 During the period of application of any derogation granted under the second indent of Article 16a (a) of Directive 71/118/EEC, the Member States shall ensure that proper checks are carried out on the initial installations and the continuous operation of the chilling processes in any establishment covered by such a derogation.    Article 5 The Member States shall bring into force the laws, regulations and administrative provisions required in order to comply with this Directive by 1 January 1978 at the latest.   Article 6 This Directive is addressed to the Member States.     Done at Brussels, 13 December 1977.  For the Council  The President  A. HUMBLET


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31977L0512

Nineteenth Commission Directive 77/512/EEC of 26 July 1977 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs

Official Journal L 207 , 13/08/1977 P. 0053 - 0054 Greek special edition: Chapter 03 Volume 19 P. 0062

****( 1 ) OJ NO L 270 , 14 . 12 . 1970 , P . 1 .  ( 2 ) OJ NO L 180 , 20 . 7 . 1977 , P . 27 .   NINETEENTH COMMISSION DIRECTIVE   OF 26 JULY 1977   AMENDING THE ANNEXES TO COUNCIL DIRECTIVE 70/524/EEC CONCERNING ADDITIVES IN FEEDINGSTUFFS  ( 77/512/EEC )   THE COMMISSION OF THE EUROPEAN   COMMUNITIES ,   HAVING REGARD TO THE TREATY ESTABLISHING THE EUROPEAN ECONOMIC COMMUNITY ,   HAVING REGARD TO COUNCIL DIRECTIVE 70/524/EEC OF 23 NOVEMBER 1970 CONCERNING ADDITIVES IN FEEDINGSTUFFS ( 1 ), AS LAST AMENDED BY EIGHTEENTH COMMISSION DIRECTIVE 77/471/EEC  ( 2 ), AND IN PARTICULAR ARTICLE 6 THEREOF ,   WHEREAS THAT DIRECTIVE PROVIDES FOR THE CONTENTS OF THE ANNEXES TO BE REGULARLY REVISED TO TAKE ACCOUNT OF DEVELOPMENTS IN SCIENTIFIC AND TECHNICAL KNOWLEDGE ;   WHEREAS CERTAIN EMULSIFIERS OF THE POLYETHYLENEGLYCOL ESTERS GROUP AND THE EMULSIFIER POLYGLYCEROL-ALKYLETHER , HITHERTO INCLUDED IN ANNEX II , HAVE BEEN WIDELY TESTED IN SEVERAL MEMBER STATES ; WHEREAS THESE SHOULD THEREFORE BE AUTHORIZED , SUBJECT TO CERTAIN CONDITIONS , AT COMMUNITY LEVEL ;   WHEREAS THE USE OF THE ANTIBIOTIC MONENSIN SODIUM FOR CATTLE FOR FATTENING HAS BEEN SUCCESSFULLY TESTED IN CERTAIN MEMBER STATES ; WHEREAS THIS SHOULD BE AUTHORIZED , SUBJECT TO CERTAIN CONDITIONS , AT LEAST AT NATIONAL LEVEL UNTIL IT IS PERMITTED AT COMMUNITY LEVEL ;   WHEREAS THE MEASURES PROVIDED FOR IN THIS DIRECTIVE ARE IN ACCORDANCE WITH THE OPINION OF THE STANDING COMMITTEE FOR FEEDINGSTUFFS ,   HAS ADOPTED THIS DIRECTIVE :   ARTICLE 1   THE ANNEXES TO DIRECTIVE 70/524/EEC ARE HEREBY AMENDED AS SET OUT IN THE FOLLOWING ARTICLES .   ARTICLE 2   ANNEX I IS AMENDED AS FOLLOWS :   IN PART E ' EMULSIFIERS , STABILIZERS , THICKENERS AND GELLING AGENTS ' , ADD :     //   //  //  //  //  //  //  MINIMUM CONTENT //  MAXIMUM CONTENT //   // EEC NO  //  ADDITIVES //  CHEMICAL FORMULA , DESCRIPTION //  SPECIES OF ANIMAL //  MAXIMUM AGE //  PPM OF COMPLETE FEEDINGSTUFF //  OTHER PROVISIONS //   // E 487 //  POLYETHYLENEGLYCOL ESTER OF FATTY ACIDS FROM SOYA OIL //  CALVES //  //  //  6 000 // E 488 //  POLYOXYETHYLATED GLYCERIDE OF TALLOW FATTY ACIDS // CALVES //  //  //  5 000 //  MILK FEEDS ONLY // E 489 //  POLYGLYCEROL-ALKYLETHER ( M.W . 650-750 ) //  CALVES //  //  //  5 000 // ****   ARTICLE 3   ANNEX II IS AMENDED AS FOLLOWS :   IN PART A ' ANTIBIOTICS ' , ADD :   //   //  //  //  CHEMICAL  //  //  //  MINIMUM CONTENT //  MAXIMUM CONTENT //   // EEC NO  //  ADDITIVES //  FORMULA , DESCRIPTION  //  SPECIES OF ANIMAL //  MAXIMUM AGE //  PPM OF COMPLETE FEEDINGSTUFF //  OTHER PROVISIONS  //  PERIOD OF AUTHORIZATION //   // 23  //  MONENSIN SODIUM //  //  CATTLE FOR FATTENING //  //  10 //  40 //  MAXIMUM DOSE IN THE DAILY RATION : //  31 DECEMBER 1979 //  //  //  //  //  //  //  //   -  CATTLE FROM THE COMMENCEMENT OF RUMINATION UP TO 250 KG : 125 MG //  //  //  //  //  //  //  //   -  CATTLE OF MORE THAN 250 KG AND UP TO 450 KG : 250 MG //  //  //  //  //  //  //  //   -  CATTLE OF MORE THAN 450 KG : 360 MG //  //  //  //  //  //  //  //  IN ADDITION TO THE LABELLING PROVISIONS REFERRED TO IN ARTICLE 10 , GIVE THE FOLLOWING INSTRUCTION ' KEEP OUT OF REACH OF EQUINE SPECIES '  //   // ARTICLE 4   MEMBER STATES SHALL BRING INTO FORCE ON 31 DECEMBER 1977 THE LAWS , REGULATIONS OR ADMINISTRATIVE PROVISIONS NECESSARY TO COMPLY WITH THIS DIRECTIVE . THEY SHALL IMMEDIATELY INFORM THE COMMISSION THEREOF .   ARTICLE 5   THIS DIRECTIVE IS ADDRESSED TO THE MEMBER STATES .   DONE AT BRUSSELS , 26 JULY 1977 .   FOR THE COMMISSION   FINN GUNDELACH   VICE-PRESIDENT


title: Directive 2006/122/EC of the European Parliament and of the Council of 12 December 2006 amending for the 30th time Council Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (perfluorooctane sulfonates)   (Text with EEA relevance)

text:
               27.12.2006

               EN

               Official Journal of the European Union

               L 372/32

      DIRECTIVE 2006/122/ECOF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 12 December 2006
   amending for the 30th time Council Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (perfluorooctane sulfonates)
   (Text with EEA relevance)
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
   Having regard to the proposal from the Commission,
   Having regard to the Opinion of the European Economic and Social Committee (1),
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
   Whereas:

               (1)

               An OECD (Organisation for Economic Cooperation and Development) hazard assessment has been done on the basis of information that was available by July 2002. This assessment concluded that perfluorooctane sulfonates (hereinafter ‘PFOS’) are persistent, bioaccumulative and toxic to mammalian species and, therefore, indicate cause for concern.

               (2)

               The risks posed to health and environment by PFOS have been assessed in accordance with the principles of Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances (3). The risk assessment identified a need to reduce the risks to health and the environment.

               (3)

               The Scientific Committee on Health and Environmental Risks (hereinafter ‘SCHER’) has been consulted. SCHER concluded that PFOS fulfil the criteria for classification as very persistent, very bioaccumulative and toxic. PFOS also have a potential for long range environmental transport and have the potential to produce adverse effects and therefore fulfil the criteria for being considered as persistent organic pollutants (POPs) under the Stockholm Convention (4). SCHER identified a need for further scientific risk assessment of PFOS but it also agreed that risk reduction measures might be necessary to avoid the re-occurrence of former uses. According to SCHER, on-going critical uses in the aviation industry, the semiconductor industry and the photographic industry do not appear to pose a relevant risk to the environment or human health, if releases into the environment and workplace exposure are minimised. With regard to fire-fighting foams, SCHER agrees that health and environmental risks of substitutes should be assessed before a final decision can be taken. SCHER also agrees with restricting the use of PFOS in the plating industry, if there are no other measures available that could be applied to reduce the emissions during metal plating to a significantly lower level.

               (4)

               In order to protect health and the environment, it therefore appears necessary that the placing on the market and the use of PFOS should be restricted. This Directive is intended to cover the major part of the exposure risks. Other minor uses of PFOS do not seem to pose a risk and they are therefore currently exempted. However, special attention should be given to plating processes using PFOS and therefore the releases from those processes need to be minimised by applying the best available techniques (hereinafter ‘BAT’) fully taking into account all relevant information contained in the BAT reference document on Surface Treatment of Metals and Plastics as developed for use under Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control (5) (IPPC Directive). In addition, Member States should establish inventories of those uses in order to acquire information about the actual quantities used and released.

               (5)

               The semi-finished products and articles containing PFOS should also be restricted in order to protect the environment. The restriction should cover all the products and articles to which PFOS are intentionally added, taking into account that PFOS may have been used only in some distinct parts or in coatings of certain products and articles, such as textiles. This Directive should only restrict new products and should not apply to products already in use or on the second hand market. However, existing stocks of fire-fighting foams containing PFOS should be identified and their use should be allowed to continue only for a limited time to prevent possible further emissions from the use of such products.

               (6)

               To ensure ultimately the phase-out of uses of PFOS the Commission should review each derogation under this Directive when new information on the uses and safer alternatives developed gives grounds for it. The derogation should only be allowed to continue for essential uses on the condition that safer substances or technologies, that are technically and economically feasible, do not exist and BAT are applied to minimise emissions of PFOS.

               (7)

               Perfluorooctanoic acid (PFOA) and its salts are suspected to have a similar risk profile to PFOS, and consequently there is a need to keep under review the ongoing risk assessment activities and the availability of safer alternatives and to define what kind of risk reduction measures, including restrictions on marketing and use, if appropriate, should be applied within the European Union.

               (8)

               Directive 76/769/EEC (6) should be amended accordingly.

               (9)

               The objective of this Directive is to introduce harmonised provisions with regard to PFOS, thus preserving the internal market whilst ensuring a high level of protection of human health and the environment, as required by Article 95 of the Treaty.

               (10)

               This Directive is without prejudice to the Community legislation laying down minimum requirements for the protection of workers, such as Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (7), and individual directives based thereon, in particular Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (codified version) (8) and Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (9),

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 76/769/EEC is hereby amended as set out in the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, not later than 27 December 2007, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those measures and a table showing the correlation between those measures and this Directive.
   They shall apply these measures from 27 June 2008.
   When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the 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 3
   This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.

   Article 4
   This Directive is addressed to the Member States.

      Done at Strasbourg, 12 December 2006.

            For the European Parliament

            The President

         J. BORRELL FONTELLES

            For the Council

            The President

         M. PEKKARINEN

      (1)  OJ C 195, 18.8.2006, p. 10.

      (2)  Opinion of the European Parliament of 25 October 2006 (not yet published in the Official Journal) and Council Decision of 11 December 2006.

      (3)  OJ L 84, 5.4.1993, p. 1. Regulation as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

      (4)  Council Decision 2006/507/EC of 14 October 2004 concerning the conclusion, on behalf of the European Community, of the Stockholm Convention on Persistent Organic Pollutants (OJ L 209, 31.7.2006, p. 1).

      (5)  OJ L 257, 10.10.1996, p. 26. Directive as last amended by Regulation (EC) No 166/2006 of the European Parliament and of the Council (OJ L 33, 4.2.2006, p. 1).

      (6)  OJ L 262, 27.9.1976, p. 201. Directive as last amended by Directive 2005/90/EC of the European Parliament and of the Council (OJ L 33, 4.2.2006, p. 28).

      (7)  OJ L 183, 29.6.1989, p. 1. Directive as amended by Regulation (EC) No 1882/2003.

      (8)  OJ L 158, 30.4.2004, p. 50. Corrigendum in OJ L 229, 29.6.2004, p. 23.

      (9)  OJ L 131, 5.5.1998, p. 11. Directive as amended by the 2003 Act of Accession.

      ANNEX
      The following point is added to Annex I to Directive 76/769/EEC:

                  ‘52.
                  Perfluorooctane sulfonates
                  (PFOS)
                  C8F17SO2X
                  (X = OH, Metal salt (O-M+), halide, amide, and other derivatives including polymers)

                              (1)

                              May not be placed on the market or used as a substance or constituent of preparations in a concentration equal to or higher than 0,005 % by mass.

                              (2)

                              May not be placed on the market in semi-finished products or articles, or parts thereof, if the concentration of PFOS is equal to or higher than 0,1 % by mass calculated with reference to the mass of structurally or microstructurally distinct parts that contain PFOS or, for textiles or other coated materials, if the amount of PFOS is equal to or higher than 1 μg/m2 of the coated material.

                              (3)

                              By way of derogation, paragraphs 1 and 2 shall not apply to the following items, nor to substances and preparations needed to produce them:

                                          (a)

                                          photoresists or anti reflective coatings for photolithography processes,

                                          (b)

                                          photographic coatings applied to films, papers, or printing plates,

                                          (c)

                                          mist suppressants for non-decorative hard chromium (VI) plating and wetting agents for use in controlled electroplating systems where the amount of PFOS released into the environment is minimised, by fully applying relevant best available techniques developed within the framework of Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control (1),

                                          (d)

                                          hydraulic fluids for aviation.

                              (4)

                              By way of derogation from paragraph 1, fire-fighting foams that have been placed on the market before 27 December 2006 can be used until 27 June 2011.

                              (5)

                              Paragraphs 1 and 2 shall apply without prejudice to Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (2).

                              (6)

                              Not later than 27 December 2008 Member States shall establish and communicate to the Commission an inventory that covers:

                                          (a)

                                          processes that are subject to derogation in paragraph 3(c) and the amounts of PFOS used in and released from them,

                                          (b)

                                          existing stocks of fire-fighting foams containing PFOS.

                              (7)

                              As soon as new information on details of uses and safer alternative substances or technologies for the uses becomes available, the Commission shall review each of the derogations in paragraph 3(a) to (d) so that:

                                          (a)

                                          the uses of PFOS will be phased out as soon as the use of safer alternatives is technically and economically feasible,

                                          (b)

                                          a derogation can only be continued for essential uses for which safer alternatives do not exist and where the efforts undertaken to find safer alternatives have been reported on,

                                          (c)

                                          releases of PFOS into the environment have been minimised, by applying best available techniques.

                              (8)

                              The Commission shall keep under review the ongoing risk assessment activities and the availability of safer alternative substances or technologies related to the uses of perfluorooctanoic acid (PFOA) and related substances and propose all necessary measures to reduce identified risks, including restrictions on marketing and use, in particular when safer alternative substances or technologies, that are technically and economically feasible, are available.’

         (1)  OJ L 257, 10.10.1996, p. 26. Directive as last amended by Regulation (EC) No 166/2006 of the European Parliament and of the Council (OJ L 33, 4.2.2006, p. 1).

         (2)  OJ L 104, 8.4.2004, p. 1. Regulation as amended by Commission Regulation (EC) No 907/2006 (OJ L 168, 21.6.2006, p. 5).


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31980L0049

Council Directive 80/49/EEC of 20 December 1979 amending the First Directive on the establishment of common rules for certain types of carriage of goods by road between Member States

Official Journal L 018 , 24/01/1980 P. 0023 - 0023 Finnish special edition: Chapter 7 Volume 2 P. 0119  Greek special edition: Chapter 07 Volume 2 P. 0122  Swedish special edition: Chapter 7 Volume 2 P. 0119  Spanish special edition: Chapter 07 Volume 2 P. 0203  Portuguese special edition Chapter 07 Volume 2 P. 0203

COUNCIL DIRECTIVE  of 20 December 1979  amending the First Directive on the establishment of common rules for certain types of carriage of goods by road between Member States  (80/49/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 75 (1) 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 provision should be made under the First Council Directive of 23 July 1962 on the establishment of common rules for certain types of carriage of goods by road between Member States (3), as last amended by Directive 78/175/EEC (4), for exemption for own-account carriage, effected by undertakings, from all quotas and authorizations,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Annex I to the First Council Directive of 23 July 1962 shall be amended as follows:    1. The following point shall be inserted:  "11. The carriage of goods in motor vehicles provided the following conditions are fulfilled:      (a) the goods carried must be the property of the undertaking or must have been sold, bought, let out on hire or hired, produced, extracted, processed or repaired by the undertaking;           (b) the purpose of the journey must be to carry the goods to or from the undertaking or to move them, either inside the undertaking or outside for its own requirements;           (c) motor vehicles used for such carriage must be driven by employees of the undertaking;           (d) the vehicles carrying the goods must be owned by the undertaking or have been bought by it on deferred terms.  This provision shall not apply to the use of a replacement vehicle during a short breakdown of the vehicle normally used;           (e) carriage must be no more than ancillary to the overall activities of the undertaking."                  2. Points 11 and 12 shall become points 12 and 13 respectively.          Article 2 Member States shall take the necessary steps to liberalize by 1 July 1980 at the latest, the types of transport referred to in Article 1.  Each Member State shall, within three months of notification of this Directive and in any event before 1 July 1980, inform the Commission of the measures taken to implement this Directive.   Article 3 This Directive is addressed to the Member States.     Done at Brussels, 20 December 1979.  For the Council  The President  J. TUNNEY  (1)OJ No C 293, 13.12.1976, p. 50. (2)OJ No C 281, 27.11.1976, p. 2. (3)OJ No 70, 6.8.1962, p. 2005/62. (4)OJ No L 54, 25.2.1978, p. 18.


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31974L0649

Council Directive 74/649/EEC of 9 December 1974 on the marketing of material for the vegetative propagation of the vine produced in third countries

Official Journal L 352 , 28/12/1974 P. 0045 - 0045 Finnish special edition: Chapter 3 Volume 6 P. 0037  Greek special edition: Chapter 03 Volume 11 P. 0133  Swedish special edition: Chapter 3 Volume 6 P. 0037  Spanish special edition: Chapter 03 Volume 8 P. 0067  Portuguese special edition Chapter 03 Volume 8 P. 0067

COUNCIL DIRECTIVE  of 9 December 1974  on the marketing of material for the vegetative propagation of the vine produced in third countries  (74/649/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community;  Having regard to Council Directive No 68/193/EEC (1) of 9 April 1968 on the marketing of material for the vegetative propagation of the vine, as last amended by Directive No 74/648/EEC (2), and in particular Article 15 (2) thereof;  Having regard to the proposal from the Commission;  Whereas the requirements for propagation material can, at present, be covered by Community production ; whereas however, it should be possible for propagation material produced in third countries to be admitted into the Community;  Whereas such propagation material must not, however, be admitted unless it offers the same guarantees as that produced within the Community;  Whereas, on the other hand, it is necessary to recognize, under certain conditions, material propagated in third countries from basic propagation material certified in a Member State as being equivalent to material propagated in that Member State,  HAS ADOPTED THIS DIRECTIVE:    Article 1 This Directive shall apply to material for the vegetative propagation of the vine (hereinafter called "propagation material") produced in third countries and marketed within the Community.   Article 2 The Member States may provide that propagation material which is obtained directly from basic propagation material certified in a Member State and grown in a third country may be certified in the State which produced the basic propagation material, if it has undergone an official field inspection establishing that the crop satisfies the conditions laid down in Annex I to Council Directive No 68/193/EEC and if it has been found at an official inspection that the conditions laid down in Annex II to the abovementioned Directive have been fulfilled.   Article 3 Acting by a qualified majority on a proposal from the Commission, the Council shall establish    (a) whether, in the cases provided for in Article 2, official inspections of crops carried out in a third country are equivalent to those carried out in the Community as regards the conditions laid down in Annex I to Council Directive No 68/193/EEC;       (b) whether propagation material grown in a third country and offering the same guarantees with regard to both characteristics and arrangements made for examination to ensure identity, for marking and for inspection, are in this respect equivalent to basic propagation material, certified propagation material or standard propagation material harvested within the Community and complying with the above Directive.          Article 4 The Member States shall bring into force on 1 July 1976, the measures necessary to comply with this Directive and shall immediately inform the Commission thereof.   Article 5 This Directive is addressed to the Member States.     Done at Brussels, 9 December 1974.  For the Council  The President  Ch. BONNET  (1)OJ No L 93, 17.4.1968, p. 15. (2)See page 43 of this Official Journal.


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31979L0139

Twenty-sixth Commission Directive 79/139/EEC of 18 December 1978 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs

Official Journal L 039 , 14/02/1979 P. 0011 - 0012 Greek special edition: Chapter 03 Volume 24 P. 0075

++++TWENTY-SIXTH COMMISSION DIRECTIVE  OF 18 DECEMBER 1978  AMENDING THE ANNEXES TO COUNCIL DIRECTIVE 70/524/EEC CONCERNING ADDITIVES IN FEEDINGSTUFFS   ( 79/139/EEC )  THE COMMISSION OF THE EUROPEAN COMMUNITIES ,  HAVING REGARD TO THE TREATY ESTABLISHING THE EUROPEAN ECONOMIC COMMUNITY ,  HAVING REGARD TO COUNCIL DIRECTIVE 70/524/EEC OF 23 NOVEMBER 1970 CONCERNING ADDITIVES IN FEEDINGSTUFFS ( 1 ) , AS LAST AMENDED BY TWENTY-FIFTH COMMISSION DIRECTIVE 78/974/EEC ( 2 ) , AND IN PARTICULAR ARTICLE 6 THEREOF ,  WHEREAS THE PROVISIONS OF DIRECTIVE 70/524/EEC LAY DOWN THAT THE ANNEXES MUST BE CONSTANTLY ADAPTED IN LINE WITH THE PROGRESS OF SCIENTIFIC AND TECHNICAL KNOWLEDGE ;  WHEREAS THE USE OF CERTAIN ANTIBIOTICS AND COCCIDIOSTATS LISTED IN ANNEX II STILL NECESSITATES ADDITIONAL EXAMINATIONS ; WHEREAS , FOR THIS REASON , THE PERIOD OF AUTHORIZATION OF THESE SUBSTANCES AT NATIONAL LEVEL MUST BE EXTENDED ; WHEREAS , PENDING A FINAL DECISION ON CITRANAXANTHINE IT IS DESIRABLE TO EXTEND THE PERIOD OF AUTHORIZATION OF THIS ADDITIVE ;  WHEREAS THE MEASURES PROVIDED FOR IN THIS DIRECTIVE ARE IN ACCORDANCE WITH THE OPINION OF THE STANDING COMMITTEE FOR FEEDINGSTUFFS ,  HAS ADOPTED THIS DIRECTIVE :  ARTICLE 1  IN ANNEX II TO DIRECTIVE 70/524/EEC :  1 . IN PART A " ANTIBIOTICS " :   ( A ) IN POSITION NO 17 , " LINCOMYCIN " , THE DATE 31 DECEMBER 1978 " IN THE COLUMN HEADED " PERIOD OF AUTHORIZATION " IS REPLACED BY " 30 JUNE 1979 " ;   ( B ) IN POSITION NO 20 , " SPIRAMYCIN " , THE TEXT IS AMENDED TO READ AS FOLLOWS :  EEC NO*ADDITIVES*CHEMICAL NAME ; DESCRIPTION*ANIMAL SPECIES*MAXIMUM AGE*PPM OF COMPLETE FEEDINGSTUFF*OTHER PROVISIONS*PERIOD OF AUTHORIZATION*  *****MINIMUM CONTENT*MAXIMUM CONTENT***  20*SPIRAMYCIN*I , C45H78O15N2*PIGLETS*FOUR MONTHS*5*50**30 JUNE 1979*  ***CALVES*16 WEEKS*5*50**30 JUNE 1979*  ***LAMBS*16 WEEKS*5*50**30 JUNE 1979*  ***KIDS*16 WEEKS*5*50**30 JUNE 1979*  **II , C47H80O16N2*PIGLETS*FOUR MONTHS*5*50**30 JUNE 1979*  ***CALVES*16 WEEKS*5*50**30 JUNE 1979*  ***LAMBS*16 WEEKS*5*50**30 JUNE 1979*  ***KIDS*16 WEEKS*5*50**30 JUNE 1979*  **III , C48H82O16N2*PIGLETS*FOUR MONTHS*5*50**30 JUNE 1979*  ***CALVES*16 WEEKS*5*50**30 JUNE 1979*  ***LAMBS*16 WEEKS*5*50**30 JUNE 1979*  ***KIDS*16 WEEKS*5*50**30 JUNE 1979*  ** ( BASE ) MACROLIDE******30 JUNE 1979*  2 . IN PART B " COCCIODIOSTATS AND OTHER MEDICINAL SUBSTANCES " :  THE DATE " 31 DECEMBER 1978 " IN THE COLUMN HEADED  " PERIOD OF AUTHORIZATION " IS REPLACED BY " 31 DECEMBER 1979 " IN THE FOLLOWING POSITIONS :  NO 2 DIMETRIDAZOLE ,  NO 6 NICARBAZINE ,  NO 12 RONIDAZOL ,  NO 22 HALOFUGINONE ;  3 . IN PART E " COLOURING MATTERS INCLUDING PIGMENTS " :  IN POSITION NO 1 " CITRANAXANTHINE " , THE DATE " 31 DECEMBER 1978 " IN THE COLUMN HEADED " PERIOD OF AUTHORIZATION " IS REPLACED BY " 31 DECEMBER 1979 " .  ARTICLE 2  THIS DIRECTIVE IS ADDRESSED TO THE MEMBER STATES .  DONE AT BRUSSELS , 18 DECEMBER 1978 .  FOR THE COMMISSION  FINN GUNDELACH  VICE-PRESIDENT  ( 1 ) OJ NO L 270 , 14 . 12 . 1970 , P . 1 .  ( 2 ) OJ NO L 330 , 25 . 11 . 1978 , P . 30 .


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31978L1032

Third Council Directive 78/1032/EEC of 19 December 1978 on the harmonization of provisions laid down by law, regulation or administrative action relating to the rules governing turnover tax and excise duty applicable in international travel

Official Journal L 366 , 28/12/1978 P. 0028 - 0030 Finnish special edition: Chapter 9 Volume 1 P. 0072  Greek special edition: Chapter 09 Volume 1 P. 0097  Swedish special edition: Chapter 9 Volume 1 P. 0072  Spanish special edition: Chapter 09 Volume 1 P. 0103  Portuguese special edition Chapter 09 Volume 1 P. 0103

THIRD COUNCIL DIRECTIVE  of 19 December 1978  on the harmonization of provisions laid down by law, regulation or administrative action relating to the rules governing turnover tax and excise duty applicable in international travel  (78/1032/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 99 thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas the action in respect of tax exemptions granted to individuals in international travel should be continued so that people in the Member States become more aware of the reality of the common market;  Whereas travel between Member States should be facilitated by an increase in exemptions from turnover tax and excise duty, the amounts of which, as fixed by Directive 69/169/EEC (4), as amended by Directive 72/230/EEC (5), have moreover been reduced, in real terms, by the rise in the cost of living in the Community as a whole;  Whereas the introduction of the European unit of account in the legal acts adopted by the institutions of the European Communities in the field of tax exemptions must not have the effect of reducing the amounts expressed in national currency at present eligible for exemption;  Whereas the rules governing tax remission at the retail stage should be harmonized in order to prevent instances of double taxation such as those resulting from the current provisions;  Whereas on account of the present economic situation a temporary derogation concerning both the unit value of goods to be imported into the Kingdom of Denmark and into Ireland and the quantitative restriction on still wines to be imported into the Kingdom of Denmark should be granted,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Article 2 of Directive 69/169/EEC is hereby amended as follows:    (a) Paragraph 1 shall be replaced by the following:  "1. Exemption from turnover tax and excise duty on imports shall apply to goods contained in the personal luggage of travellers coming from Member States of the Community provided that they fulfil the conditions laid down in Articles 9 and 10 of the Treaty, have been acquired subject  (1)OJ No C 31, 8.2.1977, p. 5. (2)OJ No C 133, 6.6.1977, p. 44. (3)OJ No C 114, 11.5.1977, p. 33. (4)OJ No L 133, 4.6.1969, p. 6. (5)OJ No L 139, 17.6.1972, p. 28.   to the general rules governing taxation on the domestic market of one of the Member States and have no commercial character and that the total value of the goods does not exceed 180 European units of account per person."       (b) In paragraph 2, "30 units of account" shall be replaced by "50 European units of account".       (c) In paragraph 3, "125 units of account" shall be replaced by "180 European units of account".       (d) The following paragraphs shall be added:  "4. Where the travel referred to in paragraph 1:      - involves transit through the territory of a third country ; overflying without landing shall not, however, be regarded as transit within the meaning of this Directive,           - begins in a part of the territory of another Member State in which turnover tax and/or excise duty is not chargeable on goods consumed within that territory,             the traveller must be able to establish that the goods transported in his luggage have been acquired subject to the general conditions governing taxation on the domestic market of a Member State and do not qualify for any refunding of turnover tax and/or excise duty, failing which Article 1 shall apply.  5. Under no circumstances may the total value of the goods exempted exceed the amount provided for in paragraph 1 or 2."          Article 2 Article 4 of Directive 69/169/EEC is hereby amended as follows:    (a) In paragraph 1 (b), second indent, column II "to a total of three litres" shall be replaced by "to a total of four litres".       (b) Paragraph 2 shall be replaced by the following:  "2. Exemption of the goods mentioned in paragraph 1 (a) and (b) shall not be granted to travellers under 17 years of age.  Exemption for the goods mentioned in paragraph 1 (d) shall not be granted to travellers under 15 years of age."       (c) The following paragraphs shall be added:  "4. Where the travel referred to in Article 2 (1):      - involves transit through the territory of a third country ; overflying without landing shall not, however, be regarded as transit within the meaning of this Directive,           - begins in a part of the territory of another Member State in which turnover tax and/or excise duty is not chargeable on goods consumed within that territory,             the traveller must be able to establish that the goods transported in his luggage have been acquired subject to the general conditions governing taxation on the domestic market of a Member State and do not qualify for any refunding of turnover tax and/or duty, failing which the quantities set out in paragraph 1, column I, shall apply.  5. Under no circumstances may the total quantity of goods exempted exceed the quantities provided for in paragraph 1, column II."          Article 3 Article 6 of Directive 69/169/EEC is hereby amended as follows:    (a) Paragraph 2 shall be replaced by the following:  "2. Without prejudice to rules relating to sales made at airport shops under customs control and on board aircraft, Member States shall take the necessary steps with regard to sales at the retail stage to permit in the cases and under the conditions provided for in paragraphs 3 and 4 the remission of turnover tax on deliveries of goods carried in the personal luggage of travellers leaving a Member State. No remission may be granted in respect of excise duty."       (b) The third subparagraph of paragraph 3 shall be replaced by the following:  "Member States may exclude their residents from the benefit of this tax remission."          Article 4 Article 7 of Directive 69/169/EEC shall be replaced by the following:  "Article 7  1. For the purposes of this Directive, "European unit of account" (EUA) shall be as defined in the Financial Regulation of 21 December 1977 (1).  2. The EUA equivalent in national currency which shall apply for the implementation of this Directive shall be fixed once a year. The rates applicable shall be those obtaining on the first working day of October with effect from 1 January of the following year.   3. Member States may round off the amounts in national currency resulting from the conversion of the amounts in EUA provided for in Articles 1 and 2, provided such rounding-off does not exceed 2 EUA.  4. Member States may maintain the amounts of the exemptions in force at the time of the annual adjustment provided for in paragraph 2 if, prior to the rounding-off provided for in paragraph 3, conversion of the amounts of the exemptions expressed in EUA would result in a change of less than 5 % in the exemption expressed in national currency. (1)OJ No L 356, 31.12.1977, p. 1."   Article 5 1. By way of derogation from Article 2 (1) of Directive 69/169/EEC, as amended by Article 1 (a) of this Directive:    - the Kingdom of Denmark may, until 31 December 1981, exclude from tax exemption goods whose unit value is in excess of 135 EUA,       - Ireland may, until 31 December 1983, exclude from tax exemption goods whose unit value is in excess of 77 EUA.         2. During the period of implementation of the derogations referred to in paragraph 1, the other Member States shall take the necessary steps to permit the remission of tax, in accordance with the procedures referred to in Article 6 (4) of Directive 69/169/EEC, on goods imported into the Kingdom of Denmark and into Ireland which are excluded from exemption in those countries.  3. By way of derogation from Article 4 (1) (b) of Directive 69/169/EEC, as amended by Article 2 (a) of this Directive, with regard to the import of still wines with exemption from turnover tax and excise duty, the Kingdom of Denmark may maintain, until 31 December 1983, the quantitative limit of three litres.   Article 6 1. Member States shall bring into force the measures necessary to comply with this Directive no later than 1 January 1979.  2. Member States shall inform the Commission of the provisions which they adopt to implement this Directive. The Commission shall inform the other Member States thereof.   Article 7 This Directive is addressed to the Member States.     Done at Brussels, 19 December 1978.  For the Council  The President  H.-D. GENSCHER


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31982L0727

Council Directive 82/727/EEC of 25 October 1982 amending Directive 69/208/EEC on the marketing of seed of oil and fibre plantsr

Official Journal L 310 , 06/11/1982 P. 0021 - 0021 Spanish special edition: Chapter 03 Volume 26 P. 0096  Portuguese special edition Chapter 03 Volume 26 P. 0096  Finnish special edition: Chapter 3 Volume 15 P. 0163  Swedish special edition: Chapter 3 Volume 15 P. 0163

*****COUNCIL  DIRECTIVE  of 25 October 1982  amending Directive 69/208/EEC on the marketing of seed of oil and fibre plants  (82/727/EEC)  THE COUNCIL OF THE EUROPEAN  COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof,  Having regard to the proposal by the Commission (1),  Having regard to the opinion of the European Parliament (2),  Whereas experience with regard to supplies of fibre flax seed shows that it is necessary to authorize the offer for sale of seed of the category of 'certified seeds of the third generation' for an indefinite period;  Whereas with regard to linseed, the production conditions developed recently in some Member States justify authorization to offer for sale seed of the category of 'certified seed of the third generation' for two further years; whereas this period should be sufficient to ensure adequate supplies of linseed on the basis of seeds of the categories 'certified seed of the first generation' and 'certified seed of the second generation'; whereas, nevertheless, provision should be made for an extension where there is good reason;  Whereas, therefore, Council Directive 69/208/EEC (3), as last amended by Directive 81/126/EEC (4), should be amended,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Article 2 (2) (c) of Directive 69/208/EEC shall be amended as follows:  1. 'flax seed' shall be replaced by 'linseed';  2. the date '30 June 1982' shall be replaced by '31 March 1984';  3. the following shall be inserted between the first and second sentences:  'Before expiry of this period this date may be postponed for one year in accordance with the procedure laid down in Article 20, where there is good reason.'  Article 2  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive with effect from 1 July 1982. They shall forthwith inform the Commission thereof.  Article 3  This Directive is addressed to the Member States.  Done at Luxembourg, 25 October 1982.  For the Council  The President  H. CHRISTOPHERSEN  (1) OJ No C 136, 28. 5. 1982, p. 4.  (2) OJ No C 238, 13. 9. 1982, p. 81.  (3) OJ No L 169, 10. 7. 1969, p. 3.  (4) OJ No L 67, 12. 3. 1981, p. 36.


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31985L0614

Council Directive 85/614/EEC of 20 December 1985 amending, on account of the accession of Spain and Portugal, Directive 85/384/EEC on the mutual recognition of diplomas, certificates and other evidence of formal qualifications in architecture, including measures to facilitate the effective exercise of the right of establishment and freedom to provide services

Official Journal L 376 , 31/12/1985 P. 0001 - 0001 Spanish special edition: Chapter 06 Volume 3 P. 0055  Finnish special edition: Chapter 6 Volume 2 P. 0130  Portuguese special edition Chapter 06 Volume 3 P. 0055  Swedish special edition: Chapter 6 Volume 2 P. 0130

COUNCIL DIRECTIVE of 20 December 1985 amending, on account of the accession of Spain and  Portugal, Directive 85/384/EEC on the mutual recognition of diplomas, certificates and other  evidence of formal qualifications in architecture, including measures to facilitate the effective  exercise of the right of establishment and freedom to provide services (85/614/EEC)THE  COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Act of Accession of Spain and Portugal,  and in particular Article 396 thereof, Whereas in view of the accession of Spain and Portugal, it  is necessary to make certain amendments to Directive 85/384/EEC  (1) to ensure its equal  application by the Kingdom of Spain and the Portuguese Republic and the other Member States,  Whereas pursuant to Article 2 (3) of the Treaty of Accession of Spain and Portugal the institutions  of the Community may adopt before accession the measures referred to in Article 396 of the Act of  Accession, the measures entering into force subject to and on the date of entry into force of the  said Treaty, HAS ADOPTED THIS DIRECTIVE: Article 1 With effect from 1 January 1986, subject to the  entry into force of the Treaty of Accession of Spain and Portugal, Article 11 of Directive  85/384/EEC shall be amended by the addition of the following: '(j)  in Spain-  the official formal  qualification of an architect (título oficial de arquitecto) awarded by the Ministry of Education  and Science or by the universities, (k)in Portugal-the Diploma ''diploma do curso especial de  arquitectura'' awarded by the Schools of Fine Arts of Lisbon and of Porto,-the Architects Diploma  'diploma de arquitecto' awarded by the Schools of Fine Arts of Lisbon and of Porto,-the Diploma  ''diploma do curso de arquitectura'' awarded by the Higher Schools of Fine Arts of Lisbon and  Porto,-the Diploma ''diploma de licenciatura em arquitectura'' awarded by the Higher School of Fine  Arts of Lisbon,-the Diploma ''carta de curso de licenciatura em arquitectura'' awarded by the  Technical University of Lisbon and the University of Porto.' Article 2 The Member States shall take  the measures necessary to comply with this Directive within the time limit specified in Article 31  (1) of Directive 85/384/EEC. Article 3 This Directive is addressed to the Member States. Done at  Brussels, 20 December 1986. For the Council The President R. KRIEPS                                                  (1)  OJ No L 223, 21. 8. 1985, p. 15.