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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. ...

... 43. Data for substances already notified in accordance with Directive 67/548/EEC should be eased into the system and should be upgraded when the next tonnage quantity threshold is reached. ...

... 70. Adverse effects on human health and the environment from substances of very high concern should be prevented through the application of appropriate risk management measures to ensure that any risks from the uses of a substance are adequately controlled, and with a view to progressively substituting these substances with a suitable safer substance. Risk management measures should be applied to ensure, when substances are manufactured, placed on the market and used, that exposure to these substances including discharges, emissions and losses, throughout the whole life-cycle is below the threshold level beyond which adverse effects may occur. For any substance for which authorisation has been granted, and for any other substance for which it is not possible to establish a safe level of exposure, measures should always be taken to minimise, as far as technically and practically possible, exposure and emissions with a view to minimising the likelihood of adverse effects. Measures to ensure adequate control should be identified in any Chemical Safety Report. These measures should be applied and, where appropriate, recommended to other actors down the supply chain. ...

... 71. Methodologies to establish thresholds for carcinogenic and mutagenic substances may be developed taking into account the outcomes of RIPs. The relevant Annex may be amended on the basis of these methodologies to allow thresholds where appropriate to be used while ensuring a high level of protection of human health and the environment. ...

... 71. Methodologies to establish thresholds for carcinogenic and mutagenic substances may be developed taking into account the outcomes of RIPs. The relevant Annex may be amended on the basis of these methodologies to allow thresholds where appropriate to be used while ensuring a high level of protection of human health and the environment. ...

... 2. As soon as the quantity of a substance per manufacturer or importer that has already been registered reaches the next tonnage threshold, the manufacturer or importer shall inform the Agency immediately of the additional information he would require under paragraph 1. Article 26(3) and (4) shall apply adapted as necessary. ...

... 2. If the quantity of a notified substance manufactured or imported per manufacturer or importer reaches the next tonnage threshold under Article 12, the additional required information corresponding to that tonnage threshold, as well as to all the lower tonnage thresholds, shall be submitted in accordance with Articles 10 and 12, unless it has already been submitted in accordance with those Articles. ...

... 2. If the quantity of a notified substance manufactured or imported per manufacturer or importer reaches the next tonnage threshold under Article 12, the additional required information corresponding to that tonnage threshold, as well as to all the lower tonnage thresholds, shall be submitted in accordance with Articles 10 and 12, unless it has already been submitted in accordance with those Articles. ...

... 2. If the quantity of a notified substance manufactured or imported per manufacturer or importer reaches the next tonnage threshold under Article 12, the additional required information corresponding to that tonnage threshold, as well as to all the lower tonnage thresholds, shall be submitted in accordance with Articles 10 and 12, unless it has already been submitted in accordance with those Articles. ...

... (a) substances meeting the criteria in Article 57(a), (b), (c) or (f) for which it is not possible to determine a threshold in accordance with section 6.4 of Annex I; ...