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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. ...
... 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. ...
... 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. ...
ARTICLE-7: Registration and notification of substances in articles [go to this ARTICLE]
... (b) the substance is present in those articles above a concentration of 0,1 % weight by weight (w/w). ...
ARTICLE-14: Chemical safety report and duty to apply and recommend risk reduction measures [go to this ARTICLE]
... 2. A chemical safety assessment in accordance with paragraph 1 need not be performed for a substance which is present in a preparation if the concentration of the substance in the preparation is less than the lowest of any of the following: ...
... (a) the applicable concentrations defined in the table of Article 3(3) of Directive 1999/45/EC; ...
... (b) the concentration limits given in Annex I to Directive 67/548/EEC; ...
... (c) the concentration limits given in Part B of Annex II to Directive 1999/45/EC; ...
... (d) the concentration limits given in Part B of Annex III to Directive 1999/45/EC; ...
... (e) the concentration limits given in an agreed entry in the classification and labelling inventory established under Title XI of this Regulation; (f) 0,1 % weight by weight (w/w), if the substance meets the criteria in Annex XIII of this Regulation. ...
ARTICLE-31: Requirements for Safety Data Sheets [go to this ARTICLE]
... (a) in an individual concentration of ≥ 1 % by weight for non-gaseous preparations and ≥ 0,2 % by volume for gaseous preparations at least one substance posing human health or environmental hazards; or ...
... (b) in an individual concentration of ≥ 0,1 % by weight for non-gaseous preparations at least one substance that is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII or has been included for reasons other than those referred to in point (a) in the list established in accordance with Article 59(1);or ...
ARTICLE-33: Duty to communicate information on substances in articles [go to this ARTICLE]
... 1. Any supplier of an article containing a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0,1 % weight by weight (w/w) shall provide the recipient of the article with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance. ...
... 2. On request by a consumer any supplier of an article containing a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0,1 % weight by weight (w/w) shall provide the consumer with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance. The relevant information shall be provided, free of charge, within 45 days of receipt of the request. ...
ARTICLE-37: Downstream user chemical safety assessments and duty to identify, apply and recommend risk reduction measures [go to this ARTICLE]
... (e) the substance is present in a preparation in a concentration lower than any of the concentrations set out in Article 14(2); (f) the downstream user is 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. ...
... (e) the substance is present in a preparation in a concentration lower than any of the concentrations set out in Article 14(2); (f) the downstream user is 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. ...
ARTICLE-56: General provisions [go to this ARTICLE]
... (a) for substances referred to in Article 57(d), (e) and (f), below a concentration limit of 0,1 % weight by weight (w/w); ...
... (b) for all other substances, below the lowest of the concentration limits specified in Directive 1999/45/EC or in Annex I to Directive 67/548/EEC which result in the classification of the preparation as dangerous. ...
ARTICLE-112: Scope [go to this ARTICLE]
... (b) substances within the scope of Article 1 of Directive 67/548/EEC, which meet the criteria for classification as dangerous in accordance with that Directive, and which are placed on the market either on their own, or in a preparation above the concentration limits specified in Directive 1999/45/EC, where relevant, which results in the classification of the preparation as dangerous. ...
ARTICLE-113: Obligation to notify the Agency [go to this ARTICLE]
... (e) specific concentration limits, where applicable, resulting from the application of Article 4(4) of Directive 67/548/EEC and Articles 4 to 7 of Directive 1999/45/EC. ...
ARTICLE-119: Electronic public access [go to this ARTICLE]
... (f) any derived no-effect level (DNEL) or predicted no-effect concentration (PNEC) established in accordance with Annex I; ...