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31989L0343

Council Directive 89/343/EEC of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for radiopharmaceuticals

Official Journal L 142 , 25/05/1989 P. 0016 - 0018 Finnish special edition: Chapter 13 Volume 19 P. 0014  Swedish special edition: Chapter 13 Volume 19 P. 0014

COUNCIL DIRECTIVE of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for radiopharmaceuticals (89/343/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,  Having regard to the proposal from the Commission (1),  In cooperation with the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas disparities in the provisions currently laid down by law, regulation or administrative action by Member States may hinder trade in radiopharmaceuticals within the Community;  Whereas the essential aim of any rules governing the production, distributio or use of medicinal products must be to safeguard public health;  Whereas the provisions laid down by Directive 65/65/EEC (4), as last amended by Directive 87/21/EEC (5), and by Second Directive 75/319/EEC (6), as last amended by Directive 83/570/EEC (7), on the approximation of provisions laid down by law, regulation  or administrative action relating to proprietary medicinal products, although appropriate, are inadequate for radiopharmaceuticals;  Whereas, in accordance with Article 5 of Council Directive 87/22/EEC of 22 December 1986 on the approximation of national provisions relating to the placing on the market of high technology medicinal products, particularly those derived from  biotechnology (8), the Commission is required to submit proposals to harmonize, along the lines of Directive 75/319/EEC, the conditions for authorizing the manufacture and placing on the market of radiopharmaceuticals before 22 December 1987;  Whereas, in the case of radiopharmaceuticals, generators, kits and precursors, authorization should be required;   whereas, however, a specific authorization should not be required for radiopharmaceuticals in their finished form which are made up exclusively from authorized kits, generators or precursor radiopharmaceuticals in health care establishments;  Whereas the Commission should be empowered to adopt any necessary changes in the requirements for the testing of proprietary medicinal products set out in the Annex to Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the  Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products (9), as last amended by Directive 87/19/EEC (10), to take account of the special nature of  radiopharmaceuticals in close cooperation with the Committee for the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Proprietary Medicinal Products Sector, thus ensuring the greater quality, safety  and efficacy of the medicinal products;  Whereas any rules governing radiopharmaceuticals must take into account the provisions of Council Directive 84/466/Euratom of 3 September 1984 laying down basic measures for the radiation protection of persons undergoing medical examination or treatment  (11); whereas account should also be taken of Council Directive 80/836/Euratom of 15 July 1980 amending the Directives laying down the basic safety standards for the health protection of the general public and workers against the dangers of ionizing radiation (12), as last amended by Directive 84/467/Euratom (13), the objective of which is to prevent the exposure of workers or patients to excessive or unnecessarily high levels of ionizing  radiation, and in particular of Article 5c thereof, which requires prior authorization for the addition of radioactive substances to medicinal products as well as for the importation of such medicinal products,  HAS ADOPTED THIS DIRECTIVE:    Article 1 1.  In derogation from Article 34 of Directive 75/319/EEC, and subject to the provisions of this Directive,  ¹ the provisions of Directives 65/65/EEC and 75/319/EEC shall apply to radiopharmaceuticals for human use, excluding radionuclides in the form of sealed sources.  2.  For the purposes of this Directive, the following definitions apply:  - 'radiopharmaceutical' shall mean any medicinal product which, when ready for use, contains one or more radionuclides (radioactive isotopes) included for a medicinal purpose,  - 'generator' shall mean any system incorporating a fixed parent radionuclide from which is produced a daughter radionuclide which is to be removed by elution or by any other method and used in a radiopharmaceutical,  - 'kit' shall mean any preparation to be reconstituted or combined with radionucliedes in the final radiopharmaceutical, usually prior to its administration,  - 'precursor' shall mean any other radionuclide produced for the radio-labelling of another substance prior to administration.  3.  Nothing in this Directive shall in any way derogate from the Community rules for the radiation protection of persons undergoing medical examination or treatment or from the Community rules laying down the basic safety standards for the health  protection of the general public and workers against the dangers of ionizing radiation.  Article 2 The authorization referred to in Article 3 of Directive 65/65/EEC shall be required for generators, kits, precursor radiopharmaceuticals and industrially prepared radiopharmaceuticals. However, authorization shall not be required for a  radiopharmaceutical prepared at the time of use by a person or by an establishment authorized, according to national legislation, to use such medicinal products in an approved health care establishment exclusively from authorized generators, kits or  precursor radiopharmaceuticals in accordance with the manufacturer's instructions.  Article 3 In addition to the requirements set out in Article 4 of Directive 65/65/EEC, an application for authorization to market a generator shall also contain the following information and particulars:  - a general description of the system together with a detailed description of the components of the system which may effect the composition or quality of the daughter nucleid preparation,  - qualitative and quantitative particulars of the eluate or the sublimate.  Article 4 For radiopharmaceuticals, in addition to the information referred to in Article 4a of Directive 65/65/EEC, the summary of product characteristics referred to in point 9 of the second paragraph of Article 4 of Directive 65/65/EEC shall contain  the following additional points 7 and 8:  '7.  Full details of internal radiation dosimetry.  '8.  Additional detailed instructions for extemporaneous preparation and quality control of such preparation and, where appropriate, maximum storage time during which any intermediate preparation such as an eluate or the ready to use pharmaceutical will  conform with its specifications.' Article 5 The outer carton and the container of medicinal products containing radionuclides shall be labelled in accordance with the regulations for the safe transport of radioactive materials laid down by the International Atomic Energy Agency.  Moreover, the labelling shall comply with the following provisions:  (a)  The label on the shielding shall include the particulars mentioned in Article 13 of Directive 65/65/EEC. In addition, the labelling on the shielding shall explain in full the codings used on the vial and shall indicate, where necessary, for a given  time and date, the amount of radioactivity per dose or per vial and the number of capsules, or, for liquids, the number of millilitres in the container;  (b)  The vial shall be labelled with the following information:  - the name or code of the medicinal product, including the name or chemical symbol of the radionuclide;  - the batch identification and expiry date,  - the international symbol for radioactivity,  - the name of the manufacturer,  - the amount of radioactivity as specified under (a).  Article 6 1.  Member States shall ensure that a detailed instruction leaflet is enclosed with the packaging of radiopharmaceuticals, generators, kits or precursor radiopharmaceuticals. The text of this leaflet shall be established in accordance with the  provisions of Article 6 of Directive 75/319/EEC and shall contain all the information referred to therein. In addition, the leaflet shall include any precautions to be taken by the user and the patient during the preparation and administration of the product and special precautions for the disposal of the container and its unused contents.  2.  Without prejudice to Article 8 of Directive 65/65/EEC and Article 6 of Directive 75/319/EEC, Member States shall permit the use of user information leaflets which have been established in more than one of the languages of the Community provided that  the information contained in all the language versions of the leaflet is identical.  Article 7 Any amendments which are necessary in the testing requirements for medicinal products set out in the Annex to Directive 75/318/EEC to take account of the extension of the scope of Directives 65/65/EEC and 75/319/EEC to cover  radiopharmaceuticals shall be adopted in accordance with the procedure laid down in Article 2c of Directive 75/318/EEC.  Article 8 1.  Save in the case provided for in paragraph 2, Member States shall take the necessary measures to comply with this Directive not later than 1 January 1992. They shall forthwith inform the Commission thereof.  2.  If the amendments to Directive 75/318/EEC referred to in Article 7 have not been adopted by the date referred to in paragraph 1, this Directive shall come into force on the same date as those amendments.  3.  Requests for marketing authorization for products covered by ths Directive lodged after the date of entry into force must comply with the provisions of this Directive.  4.  This Directive shall be progressively extended to existing radiopharmaceutical medicinal products covered by this Directive before 31 December 1992.  Article 9 This Directive is addressed to the Member States.   Done at Brussels, 3 May 1989.  For the Council The President P. SOLBES  (1) OJ No C 36, 8. 2. 1988, p. 30. (2) OJ No C 290, 14. 11. 1988, p. 136; OJ No C 120, 16. 5. 1989. (3) OJ No C 208, 8. 8. 1988, p. 64. (4) OJ No 22, 9. 2. 1965, p. 369/65. (5) OJ No L 15, 17. 1. 1987, p. 36. (6) OJ No L 147, 9. 6. 1975, p. 13. (7) OJ No L 332, 28. 11. 1983, p. 1. (8) OJ No L 15, 17. 1. 1987, p. 38.(9) OJ No L 147, 9. 6. 1975, p. 1. (10) OJ No L 15, 17. 1. 1987, p. 31. (11) OJ No L 265, 5. 10. 1984, p. 1. (12) OJ No L 246, 17. 9. 1980, p. 1. (13) OJ No L 265, 5. 10. 1984, p. 4.


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31995L0012

Commission Directive 95/12/EC of 23 May 1995 implementing Council Directive 92/75/EEC with regard to energy labelling of household washing machines

Official Journal L 136 , 21/06/1995 P. 0001 - 0027

COMMISSION DIRECTIVE  95/12/ECof 23 May 1995implementing Council Directive 92/75/EEC with regard to energy labelling of  household washing machinesTHE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 92/75/EEC of 22 September 1992 on the indication by labelling  and standard product information of the consumption of energy and other resources of household  appliances (1), and in particular Articles 9 and 12 thereof, Whereas under Directive 92/75/EEC the Commission is to adopt an implementing directive in respect  of household appliances including washing machines; Whereas electricity use by washing machines accounts for a significant part of total Community  energy demand; whereas the scope for reduced energy use by these appliances is substantial; Whereas a better washing performance often requires a higher consumption of water and energy;  whereas information on the washing performance of an appliance is helpful in evaluating the  information on its energy and water consumption; whereas this will help consumers make a choice of  appliance which is consistent with the rational use of energy; Whereas the Community, confirming its interest in an international standardization system capable  of producing standards that are actually used by all partners in international trade and of meeting  the requirements of Community policy, invites the European standards organizations to continue  their cooperation with international standards organizations; Whereas the European Committee for Standardization (CEN) and the European Committee for  Electrotechnical Standardization (Cenelec) are the bodies recognized as competent to adopt  harmonized standards in accordance with the general guidelines for cooperation between the  Commission and these two bodies signed on 13 November 1984, whereas, within the meaning of this  Directive, a harmonized standard is a technical specification (European standard or harmonization  document) adopted by Cenelec, on the basis of a remit (mandate) from the Commission in accordance  with the provisions of Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for  the provision of information in the field of technical standards and regulations (2), as last  amended by Directive 94/10/EC of the European Parliament and the Council (3), and on the basis of  those general guidelines; Whereas the measures set out in this Directive are in accordance with the opinion of the committee  set up under Article 10 of Directive 92/75/EEC, HAS ADOPTED THIS DIRECTIVE: Article 11. This Directive shall apply to electric mains operated household  washing machines, excluding: - machines with no spin capability, - machines with separate washing and spin drying vessels (such as twin tubs), and- combined  washer-driers. Appliances that can also use other energy sources are excluded. 2. The information required by this Directive shall be measured in accordance with harmonized  standards, the reference numbers of which have been published in the Official Journal of the  European Communities and for which Member States have published the reference numbers of the  national standards transposing those harmonized standards. Throughout this Directive any provisions  requiring the giving of information relating to noise shall apply where that information is  required under Article 3 of Council Directive 86/594/EEC (1). This information, where required,  shall be measured in accordance with Directive 83/189/EEC. 4. 'Dealer', 'supplier', 'information sheet', 'other essential resources' and 'supplementary  information' shall have the meanings set out in Article 1 (4) of Directive 92/75/EEC. Article 21. The technical documentation referred to in Article 2 (3) of Directive 92/75/EEC  shall include: - the name and address of the supplier, - a general description of the appliance, sufficient for it to be uniquely identified, - information, including drawings as relevant, on the main design features of the model and in  particular items which appreciably affect its energy consumption, - reports of relevant measurement tests carried out under test procedures of the harmonized  standards referred to in Article 1 (2), - operating instructions, if any. 2. The label referred to in Article 2 (1) of Directive 92/75/EEC shall be as specified in Annex I  to this Directive. The label shall be placed on the outside of the front or top of the appliance,  in such a way as to be clearly visible, and not obscured. 3. The content and format of the fiche referred to in Article 2 (1) of Directive 92/75/EEC shall be  as specified in Annex II to this Directive. 4. In the circumstances covered by Article 5 of Directive 92/75/EEC, and where the offer for sale,  hire, or hire purchase, is provided by means of a printed communication, such as a mail order  catalogue, then that printed communication shall include all the information specified in Annex III  to this Directive. 5. The energy efficiency class of an appliance, its washing performance class, and its drying  efficiency class, as specified in the label and the fiche, shall be as specified in Annex IV. Article 3Member States shall take all necessary measures to ensure that all suppliers and  dealers established in their territory fulfil their obligations under this Directive. Article 41. Member States shall adopt and publish the laws, regulations and administrative  provisions necessary to comply with this Directive by 1 March 1996. They shall immediately inform  the Commission thereof. They shall apply those provisions from 1 April 1996. However, Member States shall allow, until 30 September 1996: - the placing on the market, the commercialization and/or the display of products, - the distribution of the printed communications referred to in Article 2 (4) which do not conform  to this Directive. When Member States adopt these provisions, these shall contain a reference to this Directive or  shall be accompanied by such reference at the time of their official publication. The procedure for  such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the text of the provisions of national law  which they adopt in the field covered by this Directive. Article 5This Directive shall enter into force on the 20th day following its publication in the  Official Journal of the European Communities. Article 6This Directive is addressed to the Member States. Done at Brussels, 23 May 1995. For the CommissionChristos PAPOUTSISMember of the Commission(1) OJ No L 297,  13. 10. 1992, p. 16. (2) OJ No L 109, 26. 4. 1983, p. 8. (3) OJ No L 100, 19. 4. 1994, p. 30. (1) OJ No L 334, 6. 12. 1986, p. 24.  ANNEX I THE LABEL Label design 1. The label shall be the appropriate language version  chosen from the following illustrations: >REFERENCE TO A FILM>>REFERENCE TO A FILM>>REFERENCE TO A FILM>>REFERENCE TO A FILM>>REFERENCE  TO A FILM>>REFERENCE TO A FILM>>REFERENCE TO A FILM>>REFERENCE TO A FILM>>REFERENCE TO A FILM>> REFERENCE TO A FILM>>REFERENCE TO A FILM>>REFERENCE TO A FILM>Notes concerning the label 2.  The following notes define the information to be included: Note: I. Supplier's name or trade mark. II. Supplier's model identifier. III. The energy efficiency class of an appliance shall be determined in accordance with Annex IV.  This letter shall be placed at the same level as the relevant arrow. IV. Without prejudice to any requirements under the Community eco-label scheme, where an appliance  has been granted a 'Community eco-label' pursuant to Council Regulation (EEC) No 880/92 (1), a copy  of the eco-label may be added here. The 'Washing machine label design guide' referred to below,  explains how the eco-label mark may be included in the label. V. Energy consumption in kWh per cycle using standard 60 °C cotton cycle in accordance with the  test procedures of the harmonized standards referred to in Article 1 (2). VI. Washing performance class as determined by Annex IV. VII. Drying efficiency class as determined by Annex IV. VIII. Maximum spin speed attained for standard 60 °C cotton cycle in accordance with the test  procedures of the harmonized standards referred to in Article 1 (2). IX. Capacity of appliance for standard 60 °C cotton cycle in accordance with the harmonized  standards referred to in Article 1 (2). X. Water consumption per cycle of washing using standard 60 °C cotton cycle in accordance with the  test procedures of the harmonized standards referred to in Article 1 (2). XI. Where applicable, noise during washing and spinning cycles using standard 60 °C cycle, in  accordance with Council Directive (EEC) No 86/594 (2). Note: The equivalent terms in other languages to those given above are set out in Annex V. Printing 3. The following defines certain aspects of the label: >REFERENCE TO A FILM>Colours used: CMYK - cyan, magenta, yellow, black. For example: 07X0: 0 % cyan, 70 % magenta, 100 % yellow, 0 % black. Arrows: - A: X0X0- B: 70X0- C: 30X0- D: 00X0- E: 03X0- F: 07X0- G: 0XX0Outline colour: X070All text  is in black. The background is white. Complete printing information is contained in a 'washing machine energy label design guide', which  is for information only, obtainable from: The Secretary of the Committee on energy labelling and standard product information for household  appliances, Directorate-General for Energy XVII, European Commission, Rue de la Loi/Wetstraat 200, B-1049 Brussels. (1) OJ No L 99, 11. 4. 1992, p. 1. (2) OJ No L 344, 6. 12. 1986, p. 24. The relevant standards are EN 60704-2-4 (noise measurement)  and EN 60704-3 (verification).  ANNEX II THE FICHE The fiche shall contain the following information. The information  may be given in the form of a table covering a number of models supplied by the same supplier, in  which case it shall be given in the order specified, or given close to the description of the  appliance: 1. Supplier's trade mark. 2. Supplier's model identifier. 3. The energy efficiency class of the model as defined in Annex IV. Expressed as 'Energy efficiency  class . . . on a scale of A (most efficient) to G (least efficient). Where this information is  provided in a table, this may be expressed by other means provided it is clear that the scale is  from A (most efficient) to G (least efficient)'. 4. Where the information is provided in a table, and where some of the appliances listed in the  table have been granted an 'EU eco-label' pursuant to Regulation (EEC) No 880/92, this information  may be included here. In this case the row heading shall state 'EU eco-label', and the entry shall  consist of a copy of the eco-label mark. This provision is without prejudice to any requirements  under the Community eco-label mark scheme. 5. Energy consumption in kWh per cycle using standard 60 °C cotton cycle in accordance with the  test procedures referred to in Article 1 (2), described as 'energy consumption XYZ kWh per cycle,  based on standard test results for 60 °C cotton cycle. Actual energy consumption will depend on how  the appliance is used.'6. Washing performance class as determined by Annex IV. Expressed as  'Washing performance class . . . on a scale of A (higher) to G (lower)'. This may be expressed by  other means provided it is clear that the scale is from A (higher) to G (lower). 7. Spin drying efficiency class (Annex IV). Expressed as: 'Spin drying performance . . . on a scale  of A (higher) to G (lower)'. Followed by the statement: 'NB if you use a tumble drier. Choosing a washing machine with A-rated spin, instead of one with a  G-rated spin will halve your tumble drying costs. Tumble drying clothes usually uses more energy  than washing them.'This statement may also be included as a footnote. Where this information is provided in a table this may be expressed by other means provided it is  clear that the scale is from A (higher) to G (lower), and that the statement concerning running  costs is included in the table, or in a footnote. 8. Water extraction efficiency in accordance with the test procedures of the harmonized standards  referred to in Article 1 (2) for a standard 60 °C cotton cycle. Expressed as 'Water remaining after  spin . . . % (as a proportion of dry weight of wash)'. 9. Maximum spin speed attained for standard 60 °C cotton cycle in accordance with the test  procedures of the harmonized standards referred to in Article 1 (2). 10. Capacity of appliance for standard 60 °C cotton cycle in accordance with the test procedures of  the harmonized standards referred to in Article 1 (2). 11. Water consumption per cycle using standard 60 °C cotton cycle in accordance with the test  procedures of the harmonized standards referred to in Article 1 (2). 12. Programme time for standard 60 °C cotton cycle in accordance with the test procedures referred  to in Article 1 (2). 13. Suppliers may include the information in points 6 to 12, in respect of other wash cycles. 14. The average annual consumption of energy and water based on 200 standard 60 °C cotton cycles.  This shall be expressed as 'estimated annual consumption (200 standard 60 °C cotton washes) for a  four-person household'. 15. Noise during washing and spinning cycles using standard 60 °C cycle, in accordance with  Directive (EEC) No 86/594. If a copy of the label, either in colour or black and white, is included in the fiche, then only  the further information included in the fiche need be included. Note: The equivalent terms in other languages to those given above are set out in Annex V.  ANNEX III MAIL ORDER AND OTHER DISTANCE SELLING Mail order catalogues and other printed  communications referred to in Article 2 (4) shall contain the following information, given in the  order specified: 1. Energy efficiency class (Annex II point 3)2. Energy consumption (Annex II point 5)3. Washing  performance class (Annex II point 6)4. Spin drying efficiency class (Annex II point 7)5. Maximum  spin speed (Annex I note VIII)6. Capacity (Annex I note IX)7. Water consumption (Annex I note  X)8. Estimated annual consumption for a four-person household (Annex II point 14)9. Noise (Annex  I note XI)Where other information contained in the fiche is provided, it shall be in the form  defined in Annex II and shall be included in the above table in the order defined for the fiche. Note: The equivalent terms in other languages to those given above are set out in Annex V.  ANNEX IV ENERGY EFFICIENCY CLASS 1. The energy efficiency class of an appliance shall  be determined in accordance with the following table 1: >TABLE>2. The washing performance class of an appliance shall be determined by the  following table 2: >TABLE>3. The drying efficiency class of an appliance shall be determined by the  following table 3: >TABLE> ANNEX V >TABLE>


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31974L0387

Council Directive 74/387/EEC of 15 July 1974 amending Directives No 64/432/EEC, No 64/433/EEC, No 71/118/EEC, No 72/461/EEC and No 72/462/EEC on the validity of the procedures of the Standing Veterinary Committee

Official Journal L 202 , 24/07/1974 P. 0036 - 0037

COUNCIL DIRECTIVE  of 15 July 1974  amending Directives No 64/432/EEC, No 64/433/EEC, No 71/118/EEC, No 72/461/EEC and No 72/462/EEC on the validity of the procedures of the Standing Veterinary Committee  (74/387/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community and in particular Articles 43 and 100 thereof;  Having regard to the proposal from the Commission;  Having regard to the Opinion of the European Parliament;  Whereas the Standing Veterinary Committee, established by the Council Decision of 15 October 1968 (1), expresses its Opinion in accordance with procedures, the validity of which was limited to a period of 18 months from the date on which a request for an Opinion is first referred to the said Committee;  Whereas a matter was first referred to the Committee on 22 December 1972 ; whereas the period which has elapsed was insufficient to enable a final decision to be reached and whereas the validity of the aforementioned procedures should only be extended temporarily,  HAS ADOPTED THIS DIRECTIVE:    Article 1 In the following Articles, the term "18 months" is replaced by "30 months":    - Article 14 of Council Directive No 64/432/EEC (2) of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine, as last amended by Council Directive No 73/150/EEC (3);       - Article 9b of Council Directive No 64/433/EEC (4) of 26 June 1964 on health problems affecting intra-Community trade in fresh meat, as last amended by the Act of Accession (5), and the Council Decision of 1 January 1973 (6) adjusting the instruments concerning the accession of new Member States to the European Communities;       - Article 13 of Council Directive No 71/118/EEC (7) of 15 February 1971 on health problems affecting trade in fresh poultrymeat, last amended by the Act of Accession and the Council Decision of 1 January 1973 adjusting the instruments concerning the accession of new Member States to the European Communities;  (1)OJ No L 255, 18.10.1968, p. 23. (2)OJ No 121, 29.7.1964, p. 1977/64. (3)OJ No L 172, 28.6.1973, p. 18. (4)OJ No 121, 29.7.1964, p. 2012/64. (5)OJ No L 73, 27.3.1972, p. 14. (6)OJ No L 2, 1.1.1973, p. 1. (7)OJ No L 55, 8.3.1971, p. 23.        - Article 10 of Council Directive No 72/461/EEC (1) of 12 December 1972 on health problems affecting intra-Community trade in fresh meat, as last amended by Directive No 73/358/EEC (2);       - Article 31 of Council Directive No 72/462/EEC (3) of 12 December 1972 on health and veterinary inspection problems upon importation of bovine animals and swine and fresh meat from third countries, as last amended by Directive No 73/358/EEC.          Article 2 This Directive is addressed to the Member States.     Done at Brussels, 15 July 1974.  For the Council  The President  Christian BONNET  (1)OJ No L 302, 31.12.1972, p. 24. (2)OJ No L 326, 27.11.1973, p. 17. (3)OJ No L 302, 31.12.1972, p. 28.


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31996L0059

Council Directive 96/59/EC of 16 September 1996 on the disposal of polychlorinated biphenyls and polychlorinated terphenyls (PCB/PCT)

Official Journal L 243 , 24/09/1996 P. 0031 - 0035

COUNCIL DIRECTIVE 96/59/EC of 16 September 1996 on the disposal of polychlorinated biphenyls and polychlorinated terphenyls (PCB/PCT) THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 130s (1) thereof,Having regard to the Commission proposal (1),Having regard to the opinion of the Economic and Social Committee (2),Acting in accordance with the procedure laid down in Article 189c of the Treaty (3),(1) Whereas Council Directive 76/403/EEC of 6 April 1976 on the disposal of polychlorinated biphenyls and polychlorinated terphenyls (4) brought about an approximation of the laws of the Member States in this field; whereas those rules have not proved sufficient; whereas the state of the art has evolved to a point where disposal conditions for PCBs can be improved; whereas that Directive should therefore be replaced by a new Directive;(2) Whereas Council Directive 76/769/EEC of 27 July 1976 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 (5) underlines, the need for a periodic review of the whole problem with a view to moving gradually towards a complete ban on PCBs and PCTs;(3) Whereas the safe disposal of non-recyclable and non-reusable waste is one of the objectives of the Council Resolution of 7 May 1990 on waste policy (6), as confirmed by the Fifth Action Programme on the Environment and Sustainable Development, the approach and general strategy of which were approved by the Council and the Representatives of the Governments of the Member States, meeting within the Council, in their Resolution of 1 February 1993 (7);(4) Whereas in accordance with Council Directive 75/442/EEC of 15 July 1975 on waste (8), appropriate measures must be taken to avoid the abandonment, dumping or uncontrolled disposal of waste, and the use of processes or methods which could harm the environment;(5) Whereas in order to dispose of PCBs, because of the risks they present for the environment and for human health, general obligations concerning the controlled disposal of PCBs and the decontamination or disposal of equipment are necessary;(6) Whereas such measures should be taken as soon as possible without prejudice to the Member States' international obligations, in particular those contained in PARCOM Decision 92/3 (9); whereas PCBs which are the subject of an inventory must be disposed of by the end of 2010 at the latest;(7) Whereas the disposal of PCBs represents a transitional and temporary problem and some Member States which have no PCB disposal capacity face a force majeure situation; whereas the proximity principle should be interpreted in a flexible manner so as to permit European solidarity in this area; whereas, in addition, installations should be set up in the Community for the disposal, decontamination and storage of PCBs;(8) Whereas Council Directive 75/439/EEC of 16 June 1975 on the disposal of waste oils (10) lays down 50 ppm as the maximum limit for the PCB or PCT content of regenerated oils or oils used as fuel;(9) Whereas Council Directive 91/339/EEC of 18 June 1991, amending Directive 76/769/EEC for the eleventh time (11), prohibits or restricts the marketing of certain PCB substitutes, and whereas they too should therefore be disposed of completely;(10) Whereas it is essential to know what quantities of PCBs exist in order to be able to match disposal capacity to needs; whereas it is therefore necessary to label equipment containing PCBs and to compile inventories of such equipment; whereas such inventories must be regularly updated;(11) Whereas, bearing in mind the costs and technical difficulties entailed by an inventory of equipment slightly contaminated with PCBs, a simplified inventory should be used; whereas, in addition, provision should be made for equipment slightly contaminated by PCBs to be disposed of at the end of its useful life, bearing in mind the low risks it presents for the environment;(12) Whereas the marketing of PCBs is prohibited, and whereas the separation of PCBs from other substances for their reuse and the topping up of transformers with PCBs should therefore be prohibited; whereas, however, on safety grounds, the maintenance of transformers may be continued in order to sustain the dielectric quality of the PCBs they contain;(13) Whereas undertakings carrying out the disposal and/or decontamination of PCBs must obtain permits;(14) Whereas the conditions for decontaminating equipment containing PCBs must be defined and whereas the equipment should be specifically labelled;(15) Whereas certain technical tasks necessary for the implementation of this Directive should be carried out by the Commission, in accordance with the Committee procedure referred to in Article 18 of Directive 75/442/EEC;(16) Whereas the number of PCB disposal and decontamination plants is small and their capacity limited and the disposal and/or decontamination of the PCBs inventoried must therefore be properly planned; whereas, moreover, outlines for the collection and subsequent disposal of non-inventoried equipment should be drawn up; whereas such outlines may, if necessary, make use of existing mechanisms concerning waste in general and need not take account of very minor quantities of PCBs which cannot be identified in practice,HAS ADOPTED THIS DIRECTIVE:Article 1 The purpose of this Directive is to approximate the laws of the Member States on the controlled disposal of PCBs, the decontamination or disposal of equipment containing PCBs and/or the disposal of used PCBs in order to eliminate them completely on the basis of the provisions of this Directive.Article 2 For the purposes of this Directive:(a) 'PCBs` means:- polychlorinated biphenyls,- polychlorinated terphenyls,- Monomethyl-tetrachlorodiphenyl methane, Monomethyl-dichloro-diphenyl methane, Monomethyl-dibromo-diphenyl methane,- any mixture containing any of the abovementioned substances in a total of more than 0,005 % by weight;(b) 'equipment containing PCBs` means any equipment containing PCBs or having contained PCBs (e.g. transformers, capacitors, receptacles containing residual stocks) which has not been decontaminated. Equipment of a type which may contain PCBs shall be treated as if it contains PCBs unless it is reasonable to assume the contrary;(c) 'used PCBs` means any PCBs which are waste within the meaning of Directive 75/442/EEC;(d) 'holder` means the natural or legal person who is in possession of PCBs, used PCBs and/or equipment containing PCBs;(e) 'decontamination` means all operations which enable equipment, objects, materials or fluids contaminated by PCBs to be reused, recycled or disposed of under safe conditions, and which may include replacement, meaning all operations in which PCBs are replaced by suitable fluids not containing PCBs;(f) 'disposal` means operations D 8, D 9, D 10, D 12 (only in safe, deep, underground storage in dry rock formations and only for equipment containing PCBs and used PCBs which cannot be decontaminated) and D 15 provided for in Annex II A of Directive 75/442/EEC.Article 3 Without prejudice to their international obligations, Member States shall take the necessary measures to ensure that used PCBs are disposed of and PCBs and equipment containing PCBs are decontaminated or disposed of as soon as possible. For the equipment and the PCBs contained therein, which are subject to inventory in accordance with Article 4 (1), decontamination and/or disposal shall be effected at the latest by the end of 2010.Article 4 1. In order to comply with Article 3, Member States shall ensure that inventories are compiled of equipment with PCB volumes of more than 5 dm³, and shall send summaries of such inventories to the Commission at the latest three years after the adoption of this Directive. In the case of power capacitors, the threshold of 5 dm³ shall be understood as including all the separate elements of a combined set.2. Equipment in respect of which it is reasonable to assume that the fluids contain between 0,05 % and 0,005 % by weight of PCBs may be inventoried without the data required in the third and fourth indents of paragraph 3, and may be labelled as 'PCBs contaminated < 0,05 %`. They shall be decontaminated or disposed of in accordance with Article 9 (2).3. The inventories shall comprise the following:- the names and addresses of the holders,- the location and description of the equipment,- the quantity of PCBs contained in the equipment,- the dates and types of treatment or replacement carried out or envisaged,- the dates of declaration.If a Member State has already compiled a similar inventory, a new one shall not be required. Inventories shall be regularly updated.4. In order to comply with paragraph 1, Member States shall take the necessary measures to ensure that the holders of such equipment notify the competent authorities of the quantities which they hold and of any changes in this respect.5. Member States shall take the necessary measures to ensure that any equipment which is subject to inventory under paragraph 1 is labelled. A similar label must also be affixed to the doors of premises where such equipment is located.6. PCB-disposal undertakings shall keep registers of the quantity, origin, nature and PCB content of used PCBs delivered to them. They shall communicate this information to the competent authorities. The registers may be consulted by the local authorities and by the public. The undertakings also issue to holders who deliver used PCBs receipts specifying the nature and the quantity thereof.7. Member States shall ensure that the competent authorities monitor the quantities of which they are notified.Article 5 1. By way of derogation from Article 3 of Directive 75/442/EEC Member States shall prohibit the separation of PCBs from other substances for the purpose of reusing the PCBs.2. Member States shall prohibit the topping up of transformers with PCBs.3. Until such time as they are decontaminated, taken out of service and/or disposed of in accordance with this Directive, the maintenance of transformers containing PCBs may continue only if the objective is to ensure that the PCBs they contain comply with technical standards or specifications regarding dielectric quality and provided that the transformers are in good working order and do not leak.Article 6 1. Member States shall take the necessary measures to ensure that used PCBs and equipment containing PCBs which is subject to inventory in accordance with Article 4 (1) are transferred as soon as possible to undertakings licensed pursuant to Article 8.2. Before PCBs, used PCBs and/or equipment containing PCBs are taken by a licensed undertaking, all precautions necessary to avoid any risk of fire shall be taken. To this end they shall be kept away from any flammable products.3. Where reasonably practicable, equipment containing PCBs which is not subject to inventory in accordance with Article 4 (1) and which is part of another piece of equipment shall be removed and collected separately when the latter equipment is taken out of use, recycled or disposed of.Article 7 Member States shall take the necessary measures to prohibit any incineration of PCBs and/or used PCBs on ships.Article 8 1. Member States shall take the necessary measures to ensure that all undertakings engaged in the decontamination and/or the disposal of PCBs, used PCBs and/or equipment containing PCBs obtain permits in accordance with Article 9 of Directive 75/442/EEC.2. Where incineration is used for disposal, Council Directive 94/67/EC of 16 December 1994 on the incineration of dangerous waste (12) shall apply. Other methods of disposing of PCBs, used PCBs and/or equipment containing PCBs may be accepted provided they achieve equivalent environmental safety standards - compared with incineration - and fulfil the technical requirements referred to as best available techniques.3. Member States shall individually or jointly take the necessary measures to develop, if appropriate and taking account of Article 4 (3) (a) (ii) of Regulation (EEC) No 259/93/EEC (13) and Article 5 (1) of Directive 75/442/EEC, installations for the disposal, decontamination and safe storage of PCBs, used PCBs and/or equipment containing PCBs.Article 9 1. Member States shall take the necessary measures to ensure that transformers containing more than 0,05 % by weight of PCBs are decontaminated under the following conditions:(a) the objective of the decontamination must be to reduce the level of PCBs to less than 0,05 % by weight and, if possible, to no more than 0,005 % by weight;(b) the replacement fluid not containing PCBs must entail markedly lesser risks;(c) the replacement of the fluid must not compromise the subsequent disposal of the PCBs;(d) the labelling of the transformer after its decontamination must be replaced by the labelling specified in the Annex hereto.2. By way of derogation from Article 3, Member States shall ensure that transformers the fluids in which contain between 0,05 % and 0,005 % by weight of PCBs are either decontaminated under the conditions laid down in paragraph 1 (b) to (d) or disposed of at the end of their useful lives.Article 10 The Commission, acting in accordance with the procedure referred to in Article 18 of Directive 75/442/EEC:(a) shall fix the reference methods of measurement to determine the PCB content of contaminated materials. Measurements effected before the determination of the reference methods shall remain valid;(b) may fix technical standards for the other methods of disposing of PCBs referred to in the second sentence of Article 8 (2);(c) shall make available a list of the production names of capacitors, resistors and inductance coils, containing PCBs;(d) shall if necessary determine, solely for the purpose of Article 9 (1) (b) and (c) other less hazardous substitutes for PCBs.Article 11 1. Member States shall, within three years of the adoption of this Directive, draw up:- plans for the decontamination and/or disposal of inventoried equipment and the PCBs contained therein;- outlines for the collection and subsequent disposal of equipment which is not subject to inventory in accordance with Article 4 (1), as referred to in Article 6 (3).2. Member States shall communicate these plans and outlines to the Commission without delay.Article 12 1. Member States shall take the necessary measures to comply with this Directive not later than 18 months after its adoption. They shall forthwith inform the Commission thereof.2. When Member States adopt these provisions, these 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 Member States.3. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof.Article 13 1. This Directive shall enter into force on the date of its adoption and Directive 76/403/EEC shall be repealed with effect from that date.2. With effect from the date referred to in paragraph 1:(a) the reference in Article 10 (1) of Directive 87/101/EEC (14) to 'PCBs and PCTs within the meaning of Directive 76/403/EEC` shall be construed as a reference to PCBs within the meaning of this Directive;(b) the reference in Article 10 (2) of Directive 87/101/EEC to Directive 76/403/EEC shall be construed as a reference to this Directive;(c) the reference in Article 2 (j) of Regulation (EEC) No 259/93 to Article 6 of Directive 76/403/EEC shall be construed as a reference to Article 8 of this Directive.Article 14 This Directive is addressed to the Member States.Done at Brussels, 16 September 1996.For the CouncilThe PresidentI. YATES(1) OJ No C 319, 12. 12. 1988, p. 57.OJ No C 299, 20. 11. 1991, p. 9.(2) OJ No C 139, 5. 6. 1989, p. 1.(3) Opinions of the European Parliament of 17 May 1990 (OJ No C 149, 18. 6. 1990, p. 150) and 12 December 1990 (OJ No C 19, 28. 1. 1991, p. 83). Common position of the Council of 27 November 1995 (OJ No C 87, 25. 3. 1996, p. 1) and Decision of the European Parliament of 22 May 1996 (OJ No C 166, 10. 6. 1996, p. 76).(4) OJ No L 108, 26. 4. 1976, p. 41.(5) OJ No L 262, 27. 9. 1976, p. 201. Directive as last amended by Directive 94/60/EC (OJ No L 365, 31. 12. 1994, p. 1).(6) OJ No C 122, 18. 5. 1990, p. 2.(7) OJ No C 138, 17. 5. 1993, p. 1.(8) OJ No L 194, 25. 7. 1975, p. 39. Directive as last amended by Commission Decision 94/3/EC (OJ No L 5, 7. 1. 1994, p. 15).(9) Ministerial Meeting of the Oslo and Paris Commissions of 21-22 September 1992.(10) OJ No L 194, 25. 7. 1975, p. 23. Directive as last amended by Directive 91/692/EEC (OJ No L 377, 31. 12. 1991, p. 48).(11) OJ No L 186, 12. 7. 1991, p. 64.(12) OJ No L 365, 31. 12. 1994, p. 34.(13) OJ No L 30, 6. 2. 1993, p. 1. Regulation as amended by Commission Decision 94/721/EC (OJ No L 288, 9. 11. 1994, p. 36).(14) OJ No L 42, 12. 2. 1987, p. 43.ANNEX Labelling of decontaminated PCB equipment Each item of decontaminated equipment must be clearly marked with an indelible and embossed or engraved sign which must include the following information and be worded in the language of the country in which the equipment is used:>START OF GRAPHIC>DECONTAMINATED PCB EQUIPMENTFluid containing PCBs was replaced- with .......... (name of the substitute)- on .......... (date)- by .......... (undertaking).Concentration of PCBs in- old fluid .......... % by weight- new fluid .......... % by weight.>END OF GRAPHIC>


Avis juridique important

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32004L0006

Commission Directive 2004/6/EC of 20 January 2004 derogating from Directive 2001/15/EC to postpone the application of the prohibition of trade to certain products (Text with EEA relevance)

Official Journal L 015 , 22/01/2004 P. 0031 - 0033

Commission Directive 2004/6/ECof 20 January 2004derogating from Directive 2001/15/EC to postpone the application of the prohibition of trade to certain 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 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses(1), and in particular Article 4(2) thereof,Whereas:(1) Commission Directive 2001/15/EC of 15 February 2001 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses(2) specifies certain categories of substances and mentions for each of them the chemical substances that may be used in the manufacture of foodstuffs for particular nutritional uses. It provides that Member States are to prohibit trade in products not complying with the Directive with effect from 1 April 2004.(2) At the time of the adoption of Directive 2001/15/EC a number of substances added for specific nutritional purposes to some foods for particular nutritional uses, which are marketed in some Member States, could not be included in the Annex to that Directive because they had not been evaluated by the Scientific Committee on Food (SCF).(3) While the evaluation of those substances is being completed by the European Food Safety Authority their use should continue to be permitted in the manufacture of products marketed before the entry into force of this Directive.(4) The date of 1 April 2004 provided for in Article 3(b) of Directive 2001/15/EC makes it necessary that the present Directive should be transposed within a short deadline.(5) Therefore, a derogation from Directive 2001/15/EC should be provided for.(6) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,HAS ADOPTED THIS DIRECTIVE:Article 1By way of derogation from point (b) of the second subparagraph of Article 3 of Directive 2001/15/EC in so far as the requirements of the first subparagraph of Article 1(1) of the Directive apply and until 31 December 2006 Member States may continue to allow in their territory trade in products containing the substances listed in the Annex to this Directive provided that:(a) the European Food Safety Authority has not given an unfavourable opinion in respect of the use of the substance in the manufacture of foods for particular nutritional uses to which Directive 2001/15/EC applies;(b) the substance in question is used in the manufacture of one or more foods for particular nutritional uses marketed in the Community on the date of entry into force of this Directive.Article 21. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 March 2004 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 3This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.Article 4This Directive is addressed to the Member States.Done at Brussels, 20 January 2004.For the CommissionDavid ByrneMember of the Commission(1) OJ L 186, 30.6.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).(2) OJ L 52, 22.2.2001, p. 19.ANNEXSUBSTANCES THAT MAY BE ADDED FOR SPECIFIC NUTRITIONAL PURPOSES TO FOODS FOR PARTICULAR NUTRITIONAL USES COVERED BY DIRECTIVE 2001/15/ECCategory 1. VitaminsVITAMIN E- D-alpha-tocopheryl polyethylene glycol 1000 succinateCategory 2. MineralsBORON- boric acid- sodium borateCALCIUM- amino acid chelate- pidolateCHROMIUM- amino acid chelateCOPPER- amino acid chelateIRON- ferrous hydroxide- ferrous pidolate- amino acid chelateSELENIUM- enriched yeastMAGNESIUM- amino acid chelate- pidolateMANGANESE- amino acid chelateZINC- amino acid chelate


title: Commission Directive 2006/34/EC of  21 March 2006  amending the Annex to Directive 2001/15/EC as regards the inclusion of certain substances   (Text with EEA relevance)

text:
               22.3.2006

               EN

               Official Journal of the European Union

               L 83/14

      COMMISSION DIRECTIVE 2006/34/EC
   of 21 March 2006
   amending the Annex to Directive 2001/15/EC as regards the inclusion of certain substances
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (1), and in particular Article 4(2) thereof,
   After consulting the European Food Safety Authority,
   Whereas:

               (1)

               Commission Directive 2001/15/EC of 15 February 2001 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses (2) specifies certain categories of substances and mentions for each of them the chemical substances that may be used in the manufacture of foodstuffs for particular nutritional uses.

               (2)

               Those chemical substances that have been evaluated by the European Food Safety Authority (hereafter ‘the Authority’) and have received a favourable scientific evaluation should be included in the Annex to Directive 2001/15/EC.

               (3)

               Favourable scientific evaluation for some vitamins and mineral substances has been recently given and made public by the Authority.

               (4)

               It is appropriate to replace the category heading ‘folic acid’ in order to take account of the inclusion of other forms of folate in the Annex to Directive 2001/15/EC.

               (5)

               Directive 2001/15/EC should therefore be amended accordingly.

               (6)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   The Annex to Directive 2001/15/EC is amended as set out in the Annex to this Directive.
   Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2006 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 3
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 21 March 2006.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 186, 30.6.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

      (2)  OJ L 52, 22.2.2001, p. 19. Directive as amended by Directive 2004/5/EC (OJ L 14, 21.1.2004, p. 19).

      ANNEX
      The Annex to Directive 2001/15/EC is amended as follows:

                  1.

                  In the section concerning Category 1. Vitamins:

                              (a)

                              The heading ‘FOLIC ACID’ is replaced by ‘FOLATE’.

                              (b)

                              The following line is added under the heading ‘FOLATE’:

                                          Substance

                                          Conditions of use

                                          All FPNU

                                          FSMP

                                                      ‘—

                                                      calcium-L-methylfolate

                                          x’

                  2.

                  In the section concerning Category 2. Minerals, the following line is added under the heading ‘MAGNESIUM’:

                              Substance

                              Conditions of use

                              All FPNU

                              FSMP

                                          ‘—

                                          magnesium L-aspartate

                              x’

                  3.

                  In the section concerning Category 2. Minerals, the following line is added under the heading ‘IRON’:

                              Substance

                              Conditions of use

                              All FPNU

                              FSMP

                                          ‘—

                                          ferrous bisglycinate

                              x’