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... Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, ...
... 1. This Regulation should ensure a high level of protection of human health and the environment as well as the free movement of substances, on their own, in preparations and in articles, while enhancing competitiveness and innovation. This Regulation should also promote the development of alternative methods for the assessment of hazards of substances. ...
... 11. To ensure workability and to maintain the incentives for waste recycling and recovery, wastes should not be regarded as substances, preparations or articles within the meaning of this Regulation. ...
... 12. An important objective of the new system to be established by this Regulation is to encourage and in certain cases to ensure that substances of high concern are eventually replaced by less dangerous substances or technologies where suitable economically and technically viable alternatives are available. This Regulation does not affect the application of Directives on worker protection and the environment, especially 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)(7) 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)(8) under which employers are required to eliminate dangerous substances, wherever technically possible, or to substitute dangerous substances with less dangerous substances. ...
... 12. An important objective of the new system to be established by this Regulation is to encourage and in certain cases to ensure that substances of high concern are eventually replaced by less dangerous substances or technologies where suitable economically and technically viable alternatives are available. This Regulation does not affect the application of Directives on worker protection and the environment, especially 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)(7) 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)(8) under which employers are required to eliminate dangerous substances, wherever technically possible, or to substitute dangerous substances with less dangerous substances. ...
... 16. This Regulation lays down specific duties and obligations on manufacturers, importers and downstream users of substances on their own, in preparations and in articles. This Regulation is based on the principle that industry should manufacture, import or use substances or place them on the market with such responsibility and care as may be required to ensure that, under reasonably foreseeable conditions, human health and the environment are not adversely affected. ...
... 17. All available and relevant information on substances on their own, in preparations and in articles should be collected to assist in identifying hazardous properties, and recommendations about risk management measures should systematically be conveyed through supply chains, as reasonably necessary, to prevent adverse effects on human health and the environment. In addition, communication of technical advice to support risk management should be encouraged in the supply chain, where appropriate. ...
... 28. Scientific research and development normally takes place in quantities below 1 tonne per year. There is no need to exempt such research and development because substances in those quantities do not have to be registered in any case. However, in order to encourage innovation, product and process oriented research and development should be exempted from the obligation to register for a certain time period where a substance is not yet intended to be placed on the market to an indefinite number of customers because its application in preparations or articles still requires further research and development performed by the potential registrant himself or in cooperation with a limited number of known customers. In addition, it is appropriate to provide for a similar exemption to downstream users using the substance for the purposes of product and process oriented research and development, provided that the risks to human health and the environment are adequately controlled in accordance with the requirements of legislation for the protection of workers and the environment. ...
... 29. Since producers and importers of articles should be responsible for their articles, it is appropriate to impose a registration requirement on substances which are intended to be released from articles and have not been registered for that use. In the case of substances of very high concern which are present in articles above tonnage and concentration thresholds, where exposure to the substance cannot be excluded and where the substance has not been registered by any person for this use, the Agency should be notified. The Agency should also be empowered to request that a registration be submitted if it has grounds for suspecting that the release of a substance from the article may present a risk to human health or the environment and the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year. The Agency should consider the need for a proposal for a restriction where it considers that the use of such substances in articles poses a risk to human health or the environment that is not adequately controlled. ...
... 29. Since producers and importers of articles should be responsible for their articles, it is appropriate to impose a registration requirement on substances which are intended to be released from articles and have not been registered for that use. In the case of substances of very high concern which are present in articles above tonnage and concentration thresholds, where exposure to the substance cannot be excluded and where the substance has not been registered by any person for this use, the Agency should be notified. The Agency should also be empowered to request that a registration be submitted if it has grounds for suspecting that the release of a substance from the article may present a risk to human health or the environment and the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year. The Agency should consider the need for a proposal for a restriction where it considers that the use of such substances in articles poses a risk to human health or the environment that is not adequately controlled. ...
... 29. Since producers and importers of articles should be responsible for their articles, it is appropriate to impose a registration requirement on substances which are intended to be released from articles and have not been registered for that use. In the case of substances of very high concern which are present in articles above tonnage and concentration thresholds, where exposure to the substance cannot be excluded and where the substance has not been registered by any person for this use, the Agency should be notified. The Agency should also be empowered to request that a registration be submitted if it has grounds for suspecting that the release of a substance from the article may present a risk to human health or the environment and the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year. The Agency should consider the need for a proposal for a restriction where it considers that the use of such substances in articles poses a risk to human health or the environment that is not adequately controlled. ...
... 29. Since producers and importers of articles should be responsible for their articles, it is appropriate to impose a registration requirement on substances which are intended to be released from articles and have not been registered for that use. In the case of substances of very high concern which are present in articles above tonnage and concentration thresholds, where exposure to the substance cannot be excluded and where the substance has not been registered by any person for this use, the Agency should be notified. The Agency should also be empowered to request that a registration be submitted if it has grounds for suspecting that the release of a substance from the article may present a risk to human health or the environment and the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year. The Agency should consider the need for a proposal for a restriction where it considers that the use of such substances in articles poses a risk to human health or the environment that is not adequately controlled. ...
... 29. Since producers and importers of articles should be responsible for their articles, it is appropriate to impose a registration requirement on substances which are intended to be released from articles and have not been registered for that use. In the case of substances of very high concern which are present in articles above tonnage and concentration thresholds, where exposure to the substance cannot be excluded and where the substance has not been registered by any person for this use, the Agency should be notified. The Agency should also be empowered to request that a registration be submitted if it has grounds for suspecting that the release of a substance from the article may present a risk to human health or the environment and the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year. The Agency should consider the need for a proposal for a restriction where it considers that the use of such substances in articles poses a risk to human health or the environment that is not adequately controlled. ...
... 29. Since producers and importers of articles should be responsible for their articles, it is appropriate to impose a registration requirement on substances which are intended to be released from articles and have not been registered for that use. In the case of substances of very high concern which are present in articles above tonnage and concentration thresholds, where exposure to the substance cannot be excluded and where the substance has not been registered by any person for this use, the Agency should be notified. The Agency should also be empowered to request that a registration be submitted if it has grounds for suspecting that the release of a substance from the article may present a risk to human health or the environment and the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year. The Agency should consider the need for a proposal for a restriction where it considers that the use of such substances in articles poses a risk to human health or the environment that is not adequately controlled. ...
... 29. Since producers and importers of articles should be responsible for their articles, it is appropriate to impose a registration requirement on substances which are intended to be released from articles and have not been registered for that use. In the case of substances of very high concern which are present in articles above tonnage and concentration thresholds, where exposure to the substance cannot be excluded and where the substance has not been registered by any person for this use, the Agency should be notified. The Agency should also be empowered to request that a registration be submitted if it has grounds for suspecting that the release of a substance from the article may present a risk to human health or the environment and the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year. The Agency should consider the need for a proposal for a restriction where it considers that the use of such substances in articles poses a risk to human health or the environment that is not adequately controlled. ...
... 32. A chemical safety assessment should not need to be performed for substances in preparations in certain very small concentrations which are considered as not giving rise to concern. Substances in preparations in such low concentrations should also be exempt from authorisation. These provisions should apply equally to preparations that are solid mixtures of substances until a specific shape is given to such a preparation that transforms it into an article. ...
... 36. It is necessary to consider the application of Article 2(7)(a) and (b) and Annex XI to substances derived from mineralogical processes and the review of Annexes IV and V should fully take this into account. ...
... 56. Part of the responsibility of manufacturers or importers for the management of the risks of substances is the communication of information on these substances to other professionals such as downstream users or distributors. In addition, producers or importers of articles should supply information on the safe use of articles to industrial and professional users, and consumers on request. This important responsibility should also apply throughout the supply chain to enable all actors to meet their responsibility in relation to management of risks arising from the use of substances. ...
... 56. Part of the responsibility of manufacturers or importers for the management of the risks of substances is the communication of information on these substances to other professionals such as downstream users or distributors. In addition, producers or importers of articles should supply information on the safe use of articles to industrial and professional users, and consumers on request. This important responsibility should also apply throughout the supply chain to enable all actors to meet their responsibility in relation to management of risks arising from the use of substances. ...
... 58. In order to have a chain of responsibilities, downstream users should be responsible for assessing the risks arising from their uses of substances if those uses are not covered by a safety data sheet received from their suppliers, unless the downstream user concerned takes more protective measures than those recommended by his supplier or unless his supplier was not required to assess those risks or provide him with information on those risks. For the same reason, downstream users should manage the risks arising from their uses of substances. In addition, it is appropriate that any producer or importer of an article containing a substance of very high concern should provide sufficient information to allow safe use of such an article. ...
... 58. In order to have a chain of responsibilities, downstream users should be responsible for assessing the risks arising from their uses of substances if those uses are not covered by a safety data sheet received from their suppliers, unless the downstream user concerned takes more protective measures than those recommended by his supplier or unless his supplier was not required to assess those risks or provide him with information on those risks. For the same reason, downstream users should manage the risks arising from their uses of substances. In addition, it is appropriate that any producer or importer of an article containing a substance of very high concern should provide sufficient information to allow safe use of such an article. ...
... 73. Substitution of a substance on its own, in a preparation or in an article should be required when manufacture, use or placing on the market of that substance causes an unacceptable risk to human health or to the environment, taking into account the availability of suitable safer alternative substances and technologies, and the socio-economic benefits from the uses of the substance posing an unacceptable risk. ...
... 74. Substitution of a substance of very high concern by suitable safer alternative substances or technologies should be considered by all those applying for authorisations of uses of such substances on their own, in preparations or for incorporation of substances into articles by making an analysis of alternatives, the risks involved in using any alternative and the technical and economic feasibility of substitution. ...
... 75. The possibility of introducing restrictions on the manufacturing, placing on the market and use of dangerous substances, preparations and articles applies to all substances falling within the scope of this Regulation, with minor exemptions. Restrictions on the placing on the market and the use of substances which are carcinogenic, mutagenic or toxic to reproduction, category 1 or 2, for their use by consumers on their own or in preparations should continue to be introduced. ...
... 80. The proper interaction between the provisions on authorisation and restriction should be ensured in order to preserve the efficient functioning of the internal market and the protection of human health, safety and the environment. Restrictions that exist when the substance in question is added to the list of substances for which applications for authorisation can be submitted, should be maintained for that substance. The Agency should consider whether the risk from substances in articles is adequately controlled and, if it is not, prepare a dossier in relation to introduction of further restrictions for substances for which the use requires authorisation. ...
... 85. In relation to Annex XVII Member States should be allowed to maintain for a transitional period more stringent restrictions, provided that these restrictions have been notified according to the Treaty. This should concern substances on their own, substances in preparations and substances in articles, the manufacturing, the placing on the market and the use of which is restricted. The Commission should compile and publish an inventory of these restrictions. This would provide an opportunity for the Commission to review the measures concerned with a view to possible harmonisation. ...
... 86. It should be the responsibility of the manufacturer, importer and downstream user to identify the appropriate risk management measures needed to ensure a high level of protection for human health and the environment from the manufacturing, placing on the market or use of a substance on its own, in a preparation or in an article. However, where this is considered to be insufficient and where Community legislation is justified, appropriate restrictions should be laid down. ...
... 87. In order to protect human health and the environment, restrictions on the manufacture, placing on the market or use of a substance on its own, in a preparation or in an article may include any condition for, or prohibition of, the manufacture, placing on the market or use. Therefore it is necessary to list such restrictions and any amendments thereto. ...
... 107. The Agency should be financed partly by fees paid by natural or legal persons and partly by the general budget of the European Communities. The Community budgetary procedure should remain applicable as far as any subsidies chargeable to the general budget of the European Communities are concerned. Moreover, the auditing of accounts should be undertaken by the Court of Auditors in accordance with Article 91 of Commission Regulation (EC, Euratom) No 2343/2002 of 23 December 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities(12)107. . ...
... 107. The Agency should be financed partly by fees paid by natural or legal persons and partly by the general budget of the European Communities. The Community budgetary procedure should remain applicable as far as any subsidies chargeable to the general budget of the European Communities are concerned. Moreover, the auditing of accounts should be undertaken by the Court of Auditors in accordance with Article 91 of Commission Regulation (EC, Euratom) No 2343/2002 of 23 December 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities(12)107. . ...
... 113. The classification and labelling for any substance either subject to registration or covered by Article 1 of Directive 67/548/EEC and placed on the market should therefore be notified to the Agency to be included in the inventory. ...
... 124. In particular, power should be conferred on the Commission to amend the Annexes in certain cases, to set rules on test methods, to vary the percentage of dossiers selected for compliance checking and to modify the criteria for their selection, and to set the criteria defining what constitutes adequate justification that testing is technically not possible. Since these measures are of general scope and are designed to amend non-essential elements of this Regulation or supplement this Regulation by adding new non-essential elements thereto, they should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. ...
... 130. Since the objectives of this Regulation, namely laying down rules for substances and establishing a European Chemicals Agency, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. ...
... 130. Since the objectives of this Regulation, namely laying down rules for substances and establishing a European Chemicals Agency, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. ...
... 131. The Regulation observes the fundamental rights and principles which are acknowledged in particular in the Charter of Fundamental Rights of the European Union(24). In particular, it seeks to ensure full compliance with the principles of environmental protection and sustainable development guaranteed by Article 37 of that Charter, ...
... Commission Directive 91/155/EEC of 5 March 1991 defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations in implementation of Article 10 of Directive 88/379/EEC (OJ L 76, 22.3.1991, p. 35). Directive as last amended by Directive 2001/58/EC (OJ L212, 7.8.2001,
p. 24). ...
... Commission Directive 93/105/EC of 25 November 1993 laying down Annex VII D, containing information required for the technical dossier referred to in Article 12 of the seventh amendment of Council Directive 67/548/EEC (OJ L 294, 30.11.1993, p. 21). ...
... Commission Directive 2000/21/EC of 25 April 2000 concerning the list of Community legislation referred to in the fifth indent of Article 13(1) of Council Directive 67/548/EEC (OJ L 103, 28.4.2000, p. 70). ...
ARTICLE-1: Aim and scope [go to this ARTICLE]
... 2. This Regulation lays down provisions on substances and preparations within the meaning of Article 3. These provisions shall apply to the manufacture, placing on the market or use of such substances on their own, in preparations or in articles and to the placing on the market of preparations. ...
... 2. This Regulation lays down provisions on substances and preparations within the meaning of Article 3. These provisions shall apply to the manufacture, placing on the market or use of such substances on their own, in preparations or in articles and to the placing on the market of preparations. ...
ARTICLE-2: Application [go to this ARTICLE]
... (b) substances, on their own, in a preparation or in an article, which are subject to customs supervision, provided that they do not undergo any treatment or processing, and which are in temporary storage, or in a free zone or free warehouse with a view to re-exportation, or in transit; ...
... 2. Waste as defined in Directive 2006/12/EC of the European Parliament and of the Council(2)is not a substance, preparation or article within the meaning of Article 3 of this Regulation. ...
... 2. Waste as defined in Directive 2006/12/EC of the European Parliament and of the Council(2)is not a substance, preparation or article within the meaning of Article 3 of this Regulation. ...
... 3. Member States may allow for exemptions from this Regulation in specific cases for certain substances, on their own, in a preparation or in an article, where necessary in the interests of defence. ...
... (ii) he has been provided with the information in accordance with Articles 31 or 32 relating to the exported substance. ...
... (d) substances, on their own, in preparations or in articles, which have been registered in accordance with Title II and which are recovered in the Community if: ...
... (ii) the information required by Articles 31 or 32 relating to the substance that has been registered in accordance with Title II is available to the establishment undertaking the recovery. ...
ARTICLE-3: Definitions [go to this ARTICLE]
... 3) Article: means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition; ...
... 4) Producer of an article: means any natural or legal person who makes or assembles an article within the Community; ...
... 4) Producer of an article: means any natural or legal person who makes or assembles an article within the Community; ...
... 7) Registrant: means the manufacturer or the importer of a substance or the producer or importer of an article submitting a registration for a substance; ...
... 13) Downstream user: means any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a preparation, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user. A re-importer exempted pursuant to Article 2(7)(c) shall be regarded as a downstream user; ...
... (c) it was placed on the market in the Community, or in the countries acceding to the European Union on 1 January 1995 or on 1 May 2004, before entry into force of this Regulation by the manufacturer or importer and was considered as having been notified in accordance with the first indent of Article 8(1) of Directive 67/548/EEC but does not meet the definition of a polymer as set out in this Regulation, provided the manufacturer or importer has documentary evidence of this; ...
... 22) Product and process orientated research and development: means any scientific development related to product development or the further development of a substance, on its own, in preparations or in articles in the course of which pilot plant or production trials are used to develop the production process and/or to test the fields of application of the substance; ...
... 24) Use: means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation; ...
... 33) Supplier of an article: means any producer or importer of an article, distributor or other actor in the supply chain placing an article on the market; ...
... 33) Supplier of an article: means any producer or importer of an article, distributor or other actor in the supply chain placing an article on the market; ...
... 33) Supplier of an article: means any producer or importer of an article, distributor or other actor in the supply chain placing an article on the market; ...
... 35) Recipient of an article: means an industrial or professional user, or a distributor, being supplied with an article but does not include consumers; ...
... 35) Recipient of an article: means an industrial or professional user, or a distributor, being supplied with an article but does not include consumers; ...
ARTICLE-4: General provision [go to this ARTICLE]
... Any manufacturer, importer, or where relevant downstream user, may, whilst retaining full responsibility for complying with his obligations under this Regulation, appoint a third party representative for all proceedings under Article 11, Article 19, Title III and Article 53 involving discussions with other manufacturers, importers, or where relevant downstream users. In these cases, the identity of a manufacturer or importer or downstream user who has appointed a representative shall not normally be disclosed by the Agency to other manufacturers, importers, or, where relevant, downstream users. ...
... Any manufacturer, importer, or where relevant downstream user, may, whilst retaining full responsibility for complying with his obligations under this Regulation, appoint a third party representative for all proceedings under Article 11, Article 19, Title III and Article 53 involving discussions with other manufacturers, importers, or where relevant downstream users. In these cases, the identity of a manufacturer or importer or downstream user who has appointed a representative shall not normally be disclosed by the Agency to other manufacturers, importers, or, where relevant, downstream users. ...
... Any manufacturer, importer, or where relevant downstream user, may, whilst retaining full responsibility for complying with his obligations under this Regulation, appoint a third party representative for all proceedings under Article 11, Article 19, Title III and Article 53 involving discussions with other manufacturers, importers, or where relevant downstream users. In these cases, the identity of a manufacturer or importer or downstream user who has appointed a representative shall not normally be disclosed by the Agency to other manufacturers, importers, or, where relevant, downstream users. ...
ARTICLE-5: No data, no market [go to this ARTICLE]
... Subject to Articles 6, 7, 21 and 23, substances on their own, in preparations or in articles shall not be manufactured in the Community or placed on the market unless they have been registered in accordance with the relevant provisions of this Title where this is required. ...
... Subject to Articles 6, 7, 21 and 23, substances on their own, in preparations or in articles shall not be manufactured in the Community or placed on the market unless they have been registered in accordance with the relevant provisions of this Title where this is required. ...
ARTICLE-6: General obligation to register substances on their own or in preparations [go to this ARTICLE]
... 2. For monomers that are used as on-site isolated intermediates or transported isolated intermediates, Articles 17 and 18 shall not apply. ...
ARTICLE-7: Registration and notification of substances in articles [go to this ARTICLE]
... 1. Any producer or importer of articles shall submit a registration to the Agency for any substance contained in those articles, if both the following conditions are met: ...
... 1. Any producer or importer of articles shall submit a registration to the Agency for any substance contained in those articles, if both the following conditions are met: ...
... (a) the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year; ...
... 2. Any producer or importer of articles shall notify the Agency, in accordance with paragraph 4 of this Article, if a substance meets the criteria in Article 57 and is identified in accordance with Article 59(1), if both the following conditions are met: ...
... 2. Any producer or importer of articles shall notify the Agency, in accordance with paragraph 4 of this Article, if a substance meets the criteria in Article 57 and is identified in accordance with Article 59(1), if both the following conditions are met: ...
... 2. Any producer or importer of articles shall notify the Agency, in accordance with paragraph 4 of this Article, if a substance meets the criteria in Article 57 and is identified in accordance with Article 59(1), if both the following conditions are met: ...
... 2. Any producer or importer of articles shall notify the Agency, in accordance with paragraph 4 of this Article, if a substance meets the criteria in Article 57 and is identified in accordance with Article 59(1), if both the following conditions are met: ...
... (a) the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year; ...
... (b) the substance is present in those articles above a concentration of 0,1 % weight by weight (w/w). ...
... 3. Paragraph 2 shall not apply where the producer or importer can exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use including disposal. In such cases, the producer or importer shall supply appropriate instructions to the recipient of the article. ...
... (e) a brief description of the use(s) of the substance(s) in the article as specified in section 3.5 of Annex VI and of the uses of the article(s); (f) the tonnage range of the substance(s), such as 1-10 tonnes, 10-100 tonnes and so on. ...
... (e) a brief description of the use(s) of the substance(s) in the article as specified in section 3.5 of Annex VI and of the uses of the article(s); (f) the tonnage range of the substance(s), such as 1-10 tonnes, 10-100 tonnes and so on. ...
... 5. The Agency may take decisions requiring producers or importers of articles to submit a registration, in accordance with this Title, for any substance in those articles, if all the following conditions are met: ...
... 5. The Agency may take decisions requiring producers or importers of articles to submit a registration, in accordance with this Title, for any substance in those articles, if all the following conditions are met: ...
... (a) the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year; ...
... (ii) the release of the substance from the articles presents a risk to human health or the environment; ...
... 7. From 1 June 2011 paragraphs 2, 3 and 4 of this Article shall apply 6 months after a substance is identified in accordance with Article 59(1). ...
... 7. From 1 June 2011 paragraphs 2, 3 and 4 of this Article shall apply 6 months after a substance is identified in accordance with Article 59(1). ...
... 8. Any measures for the implementation of paragraphs 1 to 7 shall be adopted in accordance with the procedure referred to in Article 133(3). ...
ARTICLE-8: Only representative of a non-Community manufacturer [go to this ARTICLE]
... 1. A natural or legal person established outside the Community who manufactures a substance on its own, in preparations or in articles, formulates a preparation or produces an article that is imported into the Community may by mutual agreement appoint a natural or legal person established in the Community to fulfil, as his only representative, the obligations on importers under this Title. ...
... 1. A natural or legal person established outside the Community who manufactures a substance on its own, in preparations or in articles, formulates a preparation or produces an article that is imported into the Community may by mutual agreement appoint a natural or legal person established in the Community to fulfil, as his only representative, the obligations on importers under this Title. ...
...