REACH附录17英文版

COMMISSION REGULATION (EC) No 552/2009 of 22 June 2009 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC ( 1 ), and in particular Article 131 thereof, Whereas: (1) 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 ( 2 ) established in its Annex I restrictions for certain dangerous substances and preparations. Regulation (EC) No 1907/2006 repeals and replaces Directive 76/769/EEC with effect from 1 June 2009. Annex XVII to that Regulation replaces Annex I to Directive 76/769/EEC. (2) Article 67 of Regulation (EC) No 1907/2006 provides that substances, mixtures or articles may not be manu­ factured, placed on the market or used unless they comply with the conditions of any restrictions laid down in their regard in Annex XVII. (3) 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 (perfluor­ ooctane sulfonates (PFOS)) ( 3 ) and Commission Directive 2006/139/EC of 20 December 2006 amending Council Directive 76/769/EEC as regards restrictions on the marketing and use of arsenic compounds for the purpose of adapting its Annex I to technical progress ( 4 ) amending Annex I to Directive 76/769/EC were adopted shortly before Regulation (EC) No 1907/2006 was adopted, in December 2006, but the restrictions concerned have not yet been included in Annex XVII to that Regulation. Therefore Annex XVII should be amended to include the restrictions corre­ sponding to Directives 2006/122/EC and 2006/139/EC as otherwise the restrictions concerned will be repealed on 1 June 2009. (4) Pursuant to Article 137(3) of Regulation (EC) No 1907/2006, any amendment to the restrictions adopted under Directive 76/769/EEC from 1 June 2007 is to be incorporated in Annex XVII to that Regulation with effect from 1 June 2009. (5) Directive 2007/51/EC of the European Parliament and of the Council amending Council Directive 76/769/EEC relating to restrictions on the marketing of certain measuring devices containing mercury ( 5 ) was adopted on 25 September 2007. Decision 1348/2008/EC of the European Parliament and Council amending Council Directive 76/769/EEC as regards restrictions on the marketing and use of 2(2-methoxyethoxy)ethanol, 2-(2- butoxyethoxy)ethanol, methylenediphenyl diisocyanate, cyclohexane and ammonium nitrate ( 6 ) was adopted on 16 December 2008. The restrictions concerned have not yet been included in Annex XVII to that Regulation. Annex XVII should be amended to incorporate the restrictions on certain measuring devices containing mercury adopted under Directive 2007/51/EC and the restrictions on 2(2-methoxyethoxy)ethanol, 2-(2-butox­ yethoxy)ethanol, methylene-diphenyl diisocyanate, cyclo­ hexane and ammonium nitrate adopted under Decision 1348/2008/EC. (6) Account should be taken of the relevant provisions of Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directive 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 ( 7 ). (7) Since the provisions of Title VIII of Regulation (EC) No 1907/2006 and in particular Annex XVII are to be directly applicable from 1 June 2009, the restrictions should be clearly drafted in order to allow operators and enforcement authorities to apply them correctly. Therefore the drafting of the restrictions should be reviewed. The terminology for the different entries should be harmonised and made more coherent with the definitions contained in Regulation (EC) No 1907/2006. EN 26.6.2009 Official Journal of the European Union L 164/7 ( 1 ) OJ L 396, 30.12.2006, p. 1. ( 2 ) OJ L 262, 27.9.1976, p. 201. ( 3 ) OJ L 372, 27.12.2006, p. 32. ( 4 ) OJ L 384, 29.12.2006, p. 94. ( 5 ) OJ L 257, 3.10.2007, p. 13. ( 6 ) OJ L 348, 24.12.2008, p. 108. ( 7 ) OJ L 353, 31.12.2008, p. 1. (8) Council Directive 96/59/EC of 16 September 1996 on the disposal of polychlorinated biphenyls and poly­ chlorinated terphenyls (PCB/PCT) ( 1 ) requires that equipment containing PCBs and PCTs is decontaminated and disposed of as soon as possible and sets the conditions for the decontamination of equipment containing those substances. Therefore the entry in Annex XVII to Regulation (EC) 1907/2006 concerning PCTs should not include provision concerning equipment containing PCTs as that is fully regulated under Directive 96/59/EC. (9) The existing restrictions for the substances 2-naphthy­ lamine, benzidine, 4-nitrobiphenyl, 4-aminobiphenyl are ambiguous as it is unclear whether the prohibition concerns only the supply to the general public or also the supply to professional users. These should be clarified. Since 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 ( 2 ) prohibits the production, manufacture and use at work of those substances, the restrictions in Annex XVII to Regulation (EC) No 1907/2006 relating to those substances should be consistent with Directive 98/24/EC. (10) The substances carbon tetrachloride and 1,1,1-trichlor­ oethane are severely restricted under Regulation (EC) No 2037/2000 of the European Parliament and of the Council of 29 June 2000 on substances that deplete the ozone layer ( 3 ). Regulation (EC) No 2037/2000 imposes for carbon tetrachloride a prohibition with exceptions, and for 1,1,1-trichloroethane a complete prohibition. Restrictions on carbon tetrachloride and 1,1,1-trichlor­ oethane in Annex XVII to Regulation (EC) 1907/2006 are therefore superfluous and should be deleted. (11) Since mercury in batteries is regulated under Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumu­ lators and waste batteries and accumulators ( 4 ), the provisions on mercury in batteries currently contained in Annex XVII to Regulation (EC) No 1907/2006 are superfluous and should therefore be deleted. (12) Pursuant to Article 2(2) of Regulation (EC) No 1907/2006, waste is considered not to be a substance, a mixture, or an article within the meaning of Article 3 of Regulation (EC) No 1907/2006. Therefore since waste is not covered by the restrictions under that Regulation, provisions in Annex XVII thereto excluding waste are redundant and should be deleted. (13) Certain restrictions in Annex XVII to Regulation (EC) 1907/2006 should be modified in order to take into account the definitions of ‘use’ and ‘placing on the market’ contained in Article 3 of that Regulation. (14) The entry in Annex I to Directive 76/769/EEC concerning asbestos fibres included an exemption for diaphragms containing chrysotile. It should be specified that this exemption will be reviewed following receipt of reports that Member States who are making use of this exemption will have to submit. Moreover in the light of the definition of ‘placing on the market’ in Regulation (EC) No 1907/2006, Member States should be able to allow the placing on the market of some articles containing such fibres where the articles were already installed or in service before 1 January 2005, under specific conditions ensuring a high level of protection of human health (15) It should be made clear that, for substances which have been incorporated in Annex XVII to Regulation (EC) No 1907/2006 as a consequence of restrictions adopted in the framework of Directive 76/769/EEC (Entries 1 to 58), the restrictions do not apply to storage, keeping, treatment, filling into containers, or transfer from one container to another of the substances for export, unless the manufacture of the substances is prohibited. (16) Unlike Directive 76/769/EEC, Regulation (EC) No 1907/2006 defines the term ‘article’. In order to cover the same items as provided for in the original restriction on Cadmium, the term ‘mixtures’ should be added in some of the provisions. (17) It should be made clear that the restrictions incorporated in Annex XVII to Regulation (EC) No 1907/2006 on the marketing of certain measuring devices containing mercury do not apply to devices already in use in the Community at the time of entry into force of the restriction. (18) In the entries in Annex XVII to Regulation (EC) 1907/2006 for the substances diphenylether, pentabromo derivatives and diphenylether, octabromo derivatives, it should be provided that the restrictions do not apply to articles already in use at the date from which the restriction was to apply as those substances were incorporated in articles which have a long lifecycle and are sold on the second hand market, such as aero­ planes and vehicles. Moreover, since the use of the substances in electrical and electronic equipments is regulated under Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the restriction of the use of certain hazardous substances in electrical and electronic equipment ( 5 ) that equipment should not be subject to the restrictions concerned. EN L 164/8 Official Journal of the European Union 26.6.2009 ( 1 ) OJ L 243, 24.9.1996, p. 31. ( 2 ) OJ L 131, 5.5.1998, p. 11. ( 3 ) OJ L 244, 29.9.2000, p. 1. ( 4 ) OJ L 266, 26.9.2006, p. 1. ( 5 ) OJ L 37, 13.2.2003, p. 19. (19) It should be made clear in the restriction on nonylphenol and nonylphenol ethoxylate that the validity of existing national authorisations for pesticides and biocidal products containing nonylphenol ethoxylate as co- formulant should not be affected, as provided for in Article 1(2) of Directive 2003/53/EC of the European Parliament and of the Council of 18 June 2003 amending for the 26th time Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations (nonylphenol, nonylphenol ethoxylate and cement) ( 1 ). (20) It should be made clear that the restriction incorporated in Annex XVII to Regulation (EC) No 1907/2006 concerning perfluorooctane sulfonates does not apply to products which were already in use in the Community when the restriction entered into force. (21) The measures provided for in this Regulation are in accordance with the opinion of the Committee estab­ lished under Article 133 of Regulation (EC) No 1907/2006, HAS ADOPTED THIS REGULATION: Article 1 Annex XVII to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to this Regulation. Article 2 This Regulation shall enter into force on the day following its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 22 June 2009. For the Commission Günter VERHEUGEN Vice-President EN 26.6.2009 Official Journal of the European Union L 164/9 ( 1 ) OJ L 178, 17.7.2003, p. 24. ANNEX Annex XVII to Regulation (EC) No 1907/2006 is amended as follows: 1. the title is replaced by the following: ‘Restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles’; 2. the table setting out the designation of the substances, groups of substances and mixtures and the conditions of restriction is replaced by the following: ‘For substances which have been incorporated in this Annex as a consequence of restrictions adopted in the framework of Directive 76/769/EEC (Entries 1 to 58), the restrictions shall not apply to storage, keeping, treatment, filling into containers, or transfer from one container to another of these substances for export, unless the manufacture of the substances is prohibited. Column 1 Designation of the substance, of the group of substances or of the mixture Column 2 Conditions of restriction 1. Polychlorinated terphenyls (PCTs) Shall not be placed on the market, or used: — as substances, — in mixtures, including waste oils, or in equipment, in concentrations greater than 50 mg/kg (0,005 % by weight). 2. Chloroethene (vinyl chloride) CAS No 75-01-4 EC No 200-831-0 Shall not be used as propellant in aerosols for any use. Aerosols dispensers containing the substance as propellant shall not be placed on the market. 3. Liquid substances or mixtures, which are regarded as dangerous according to the definitions in Council Directive 67/548/EEC and Directive 1999/45/EC. 1. Shall not be used in: — ornamental articles, intended to produce light or colour effects by means of different phases, for example in ornamental lamps and ashtrays, — tricks and jokes, — games for one or more participants, or any article intended to be used as such, even with ornamental aspects. 2. Articles not complying with paragraph 1 shall not be placed on the market. 3. Shall not be placed on the market if they contain a colouring agent unless required for fiscal reasons or perfume or both and if they: — present an aspiration hazard and are labelled with R65 or H304, and, — can be used as fuel in decorative lamps, and, — are packaged in containers of a capacity of 15 litres or less. 4. Without prejudice to the implementation of other Community provisions relating to the classification, packaging and labelling of substances and mixtures, suppliers shall ensure before the placing on the market that the packaging of substances and mixtures covered by paragraph 3, where intended for use in lamps, is marked visibly, legibly and indelibly as follows: “Keep lamps filled with this liquid out of the reach of children”. EN L 164/10 Official Journal of the European Union 26.6.2009 Column 1 Designation of the substance, of the group of substances or of the mixture Column 2 Conditions of restriction 4. Tris (2,3 dibromopropyl) phosphate CAS No 126-72-7 1. Shall not be used in textile articles, such as garments, undergarments and linen, intended to come into contact with the skin. 2. Articles not complying with paragraph 1 shall not be placed on the market. 5. Benzene CAS No 71-43-2 EC No 200-753-7 1. Shall not be used in toys or parts of toys where the concentration of benzene in the free state is greater than 5 mg/kg (0,0005 %) of the weight of the toy or part of toy. 2. Toys and parts of toys not complying with paragraph 1 shall not be placed on the market. 3. Shall not be placed on the market, or used, — as a substance, — as a constituent of other substances, or in mixtures, in concentrations equal to, or greater than 0,1 % by weight. 4. However, paragraph 3 shall not apply to: (a) motor fuels which are covered by Directive 98/70/EC; (b) substances and mixtures for use in industrial processes not allowing for the emission of benzene in quantities in excess of those laid down in existing legislation. 6. Asbestos fibres (a) Crocidolite CAS No 12001-28-4 (b) Amosite CAS No 12172-73-5 (c) Anthophyllite CAS No 77536-67-5 (d) Actinolite CAS No 77536-66-4 (e) Tremolite CAS No 77536-68-6 (f) Chrysotile CAS No 12001-29-5 CAS No 132207-32-0 1. The manufacture, placing on the market and use of these fibres and of articles containing these fibres added intentionally is prohibited. However, Member States may exempt the placing on the market and use of diaphragms containing chrysotile (point (f)) for existing electrolysis installations until they reach the end of their service life, or until suitable asbestos-free substitutes become available, whichever is the sooner. By 1 June 2011 Member States making use of this exemption shall provide a report to the Commission on the availability of asbestos free substitutes for electrolysis installations and the efforts undertaken to develop such alternatives, on the protection of the health of workers in the installations, on the source and quantities of chrysotile, on the source and quantities of diaphragms containing chrysotile, and the envisaged date of the end of the exemption. The Commission shall make this information publicly available. Following receipt of those reports, the Commission shall request the Agency to prepare a dossier in accordance with Article 69 with a view to prohibit the placing on the market and use of diaphragms containing chrysotile. 2. The use of articles containing asbestos fibres referred to in paragraph 1 which were already installed and/or in service before 1 January 2005 shall continue to be permitted until they are disposed of or reach the end of their service life. However, Member States may, for reasons of protection of human health, restrict, prohibit or make subject to specific conditions, the use of such articles before they are disposed of or reach the end of their service life. Member States may allow placing on the market of articles in their entirety containing asbestos fibres referred to in paragraph 1 which were already installed and/or in service before 1 January 2005, under specific conditions ensuring a high level of protection of human health. Member States shall communicate these national measures to the Commission by 1 June 2011. The Commission shall make this infor­ mation publicly available. EN 26.6.2009 Official Journal of the European Union L 164/11 Column 1 Designation of the substance, of the group of substances or of the mixture Column 2 Conditions of restriction 3. Without prejudice to the application of other Community provisions on the classification, packaging and labelling of substances and mixtures, the placing on the market and use of articles containing these fibres, as permitted according to the preceding derogations, shall be permitted only if suppliers ensure before the placing on the market that articles bear a label in accordance with Appendix 7 to this Annex. 7. Tris(aziridinyl)phosphinoxide CAS No 545-55-1 EC No 208-892-5 1. Shall not be used in textile articles, such as garments, undergarments and linen, intended to come into contact with the skin. 2. Articles not complying with paragraph 1 shall not be placed on the market. 8. Polybromobiphenyls; Polybromi­ natedbiphenyls (PBB) CAS No 59536-65-1 1. Shall not be used in textile articles, such as garments, undergarments and linen, intended to come into contact with the skin. 2. Articles not complying with paragraph 1 shall not be placed on the market. 9. (a) Soap bark powder (Quillaja saponaria) and its de­ rivatives containing saponines CAS No 68990-67-0 EC 273-620-4 (b) Powder of the roots of Helleborus viridis and Helleborus niger (c) Powder of the roots of Veratrum album and Veratrum nigrum (d) Benzidine and/or its deriva­ tives CAS No 92-87-5 EC No 202-199-1 (e) o-Nitrobenzaldehyde CAS No 552-89-6 EC No 209-025-3 (f) Wood powder 1. Shall not be used, in jokes and hoaxes or in mixtures or articles intended to be used as such, for instance as a