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... 10. Substances under customs supervision which are in temporary storage, in free zones or free warehouses with a view to re-exportation or in transit are not used within the meaning of this Regulation and should therefore be excluded from its scope. The carriage of dangerous substances and of dangerous preparations by rail, road, inland waterways, sea or air should also be excluded from its scope as specific legislation already applies to such carriage. ...

... 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. ...

... 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. ...

... 76. Experience at international level shows that substances with characteristics rendering them persistent, liable to bioaccumulate and toxic, or very persistent and very liable to bioaccumulate, present a very high concern, while criteria have been developed allowing the identification of such substances. For certain other substances concerns are sufficiently high to address them in the same way on a case-by-case basis. The criteria in Annex XIII should be reviewed taking into account the current and any new experience in the identification of these substances and if appropriate, be amended with a view to ensuring a high level of protection for human health and the environment. ...

... 77. In view of workability and practicality considerations, both as regards natural or legal persons, who have to prepare application files and take appropriate risk management measures, and as regards the authorities, who have to process authorisation applications, only a limited number of substances should be subjected to the authorisation procedure at the same time and realistic deadlines should be set for applications, while allowing certain uses to be exempted. Substances identified as meeting the criteria for authorisation should be included in a candidate list for eventual inclusion in the authorisation procedure. Within this list, substances on the Agency's work programme should be clearly identified. ...

... 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. ...

... 122. In order to ensure transparency, impartiality and consistency in the level of enforcement activities by Member States, it is necessary for Member States to set up an appropriate framework for penalties with a view to imposing effective, proportionate and dissuasive penalties for non-compliance, as non-compliance can result in damage to human health and the environment. ...

... (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. These methods shall be regularly reviewed and improved with a view to reducing testing on vertebrate animals and the number of animals involved. The Commission, following consultation with relevant stakeholders, shall, as soon as possible, make a proposal, if appropriate, to amend the Commission Regulation on test methods adopted in accordance with the procedure referred to in Article 133(4), and the Annexes of this Regulation, if relevant, so as to replace, reduce or refine animal testing. Amendments to that Commission Regulation shall be adopted in accordance with the procedure specified in paragraph 3 and amendments to the Annexes of this Regulation shall be adopted in accordance with the procedure referred to in Article 131. ...

... 1. In order to ensure a harmonised approach, the Agency shall in cooperation with the Member States develop criteria for prioritising substances with a view to further evaluation. Prioritisation shall be on a risk-based approach. The criteria shall consider: ...

... The number of substances included in Annex XIV and the dates specified under paragraph 1 shall also take account of the Agency's capacity to handle applications in the time provided for. The Agency shall make its first recommendation of priority substances to be included in Annex XIV by 1 June 2009. The Agency shall make further recommendations at least every second year with a view to including further substances in Annex XIV. ...

... Within nine months of the date of publication referred to in Article 69(6), the Committee for Risk Assessment shall formulate an opinion as to whether the suggested restrictions are appropriate in reducing the risk to human health and/or the environment, based on its consideration of the relevant parts of the dossier. This opinion shall take account of the Member State dossier or of the dossier prepared by the Agency at the request of the Commission, and the views of interested parties referred to in point (a) of Article 69(6). ...

... (h) examining proposals for restrictions with a view to advising on enforceability. ...

... The competent authorities of the Member States shall inform the general public about the risks arising from substances where this is considered necessary for the protection of human health or the environment. The Agency, in consultation with competent authorities and stakeholders and drawing as appropriate on relevant best practice, shall provide guidance for the communication of information on the risks and safe use of chemical substances, on their own, in preparations or in articles, with a view to coordinating Member States in these activities. ...

... 4. The Commission shall carry out a review of Annexes I, IV and V by 1 June 2008, with a view to proposing amendments, if appropriate, to them in accordance with the procedure referred to in Article 131. ...

... 5. The Commission shall carry out a review of Annex XIII by 1 December 2008, to assess the adequacy of the criteria for identifying substances which are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative, with a view to proposing an amendment to it, if appropriate, in accordance with the procedure referred to in Article 133(4). ...