2Recitals 15, 18 to 20, 44, 47, 66, 121 and 122 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1, and corrigendum OJ 2007 L 136, p. 3), as amended by Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 (OJ 2008 L 353, p. 1) (‘the REACH Regulation’), provide as follows:(15) There is a need to ensure effective management of the technical, scientific and administrative aspects of this Regulation at [Union] level. A central entity should therefore be created to fulfil this role. A feasibility study on the resource requirements for this central entity concluded that an independent central entity offered a number of long-term advantages over other options. A European Chemicals Agency (hereinafter referred to as “[ECHA]”) should therefore be established.…(18) Responsibility for the management of the risks of substances should lie with the natural or legal persons that manufacture, import, place on the market or use these substances. …(19) Therefore, the registration provisions should require manufacturers and importers to generate data on the substances they manufacture or import, to use these data to assess the risks related to these substances and to develop and recommend appropriate risk management measures. To ensure that they actually meet these obligations, as well as for transparency reasons, registration should require them to submit a dossier containing all this information to [ECHA] …(20) The evaluation provisions should provide for follow-up to registration, by allowing for checks on whether registrations are in compliance with the requirements of this Regulation and if necessary by allowing for generation of more information on the properties of substances. If [ECHA] in cooperation with the Member States considers that there are grounds for considering that a substance constitutes a risk to human health or the environment, [ECHA] should, after having included the substance in the Community rolling action plan for substance evaluation, relying on the competent authorities of Member States, ensure that this substance is evaluated.…(44) In order to provide a harmonised, simple system, all registrations should be submitted to [ECHA]. To ensure a consistent approach and efficient use of resources, it should perform a completeness check on all registrations and take responsibility for any final rejections of registrations.…(47) In accordance with [Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (OJ 1986 L 358, p. 1)], it is necessary to replace, reduce or refine testing on vertebrate animals. Implementation of this Regulation should be based on the use of alternative test methods, suitable for the assessment of health and environmental hazards of chemicals, wherever possible. The use of animals should be avoided by recourse to alternative methods validated by the Commission or international bodies, or recognised by the Commission or [ECHA] as appropriate to meet the information requirements under this Regulation.…(66) [ECHA] should also be empowered to require further information from manufacturers, importers or downstream users on substances suspected of posing a risk to health or the environment, … on the basis of evaluations performed. Based on the criteria for prioritising substances developed by [ECHA] in cooperation with the Member States a Community rolling action plan for substance evaluation should be established, relying on Member State competent authorities to evaluate substances included therein.…(121) In order to ensure compliance with this Regulation, Member States should put in place effective monitoring and control measures. The necessary inspections should be planned, carried out and their results should be reported.(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.’
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