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... 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. ...
... 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. ...
ARTICLE-3: Definitions [go to this ARTICLE]
... 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; ...
... 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; ...
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: ...
... (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: ...
... (a) the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year; ...
... 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. ...
... 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. ...
... (a) the identity and contact details of the producer or importer as specified in section 1 of Annex VI, with the exception of their own use sites; ...
... 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; ...
ARTICLE-9: Exemption from the general obligation to register for product and process orientated research and development (PPORD) [go to this ARTICLE]
... 1. Articles 5, 6, 7, 17, 18 and 21 shall not apply for a period of five years to a substance manufactured in the Community or imported for the purposes of product and process orientated research and development by a manufacturer or importer or producer of articles, by himself or in cooperation with listed customers and in a quantity which is limited to the purpose of product and process orientated research and development. ...
... 2. For the purpose of paragraph 1, the manufacturer or importer or producer of articles shall notify the Agency of the following information: ...
... (a) the identity of the manufacturer or importer or producer of articles as specified in section 1 of Annex VI; ...
... 3. The Agency shall check the completeness of the information supplied by the notifier and Article 20(2) shall apply adapted as necessary. The Agency shall assign a number to the notification and a notification date, which shall be the date of receipt of the notification at the Agency, and shall forthwith communicate that number and date to the manufacturer, or importer, or producer of articles concerned. The Agency shall also communicate this information to the competent authority of the Member State(s) concerned. ...
... 5. In the absence of any indication to the contrary, the manufacturer or importer of the substance or the producer or importer of articles may manufacture or import the substance or produce or import the articles not earlier than two weeks after the notification. ...
... 6. The manufacturer or importer or producer of articles shall comply with any conditions imposed by the Agency in accordance with paragraph 4. ...
... 7. The Agency may decide to extend the five-year exemption period by a further maximum of five years or, in the case of substances to be used exclusively in the development of medicinal products for human or veterinary use, or for substances that are not placed on the market, for a further maximum of ten years, upon request if the manufacturer or importer or producer of articles can demonstrate that such an extension is justified by the research and development programme. ...
ARTICLE-12: Information to be submitted depending on tonnage [go to this ARTICLE]
ARTICLE-22: Further duties of registrants [go to this ARTICLE]
... (a) any change in his status, such as being a manufacturer, an importer or a producer of articles, or in his identity, such as his name or address; ...
ARTICLE-77: Tasks [go to this ARTICLE]
... (g) providing technical and scientific guidance and tools where appropriate for the operation of this Regulation in particular to assist the development of chemical safety reports (in accordance with Article 14, Article 31(1) and Article 37(4)) and application of Article 10(a)(viii), Article 11(3) and Article 19(2) by industry and especially by SMEs; and technical and scientific guidance for the application of Article 7 by producers and importers of articles; ...
ARTICLE-113: Obligation to notify the Agency [go to this ARTICLE]
... 1. Any manufacturer, producer of articles or importer, or group of manufacturers or producers of articles or importers, who place on the market a substance within the scope of Article 112, shall notify to the Agency the following information in order for it to be included in the inventory in accordance with Article 114, unless submitted as part of the registration: ...
... 1. Any manufacturer, producer of articles or importer, or group of manufacturers or producers of articles or importers, who place on the market a substance within the scope of Article 112, shall notify to the Agency the following information in order for it to be included in the inventory in accordance with Article 114, unless submitted as part of the registration: ...
... (a) the identity(ies) of the manufacturer(s), producer(s) of articles or importer(s) responsible for placing the substance(s) on the market as specified in section 1 of Annex VI; ...