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... 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 the Agency 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, the Agency 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. ...

... 28. Scientific research and development normally takes place in quantities below 1 tonne per year. There is no need to exempt such research and development because substances in those quantities do not have to be registered in any case. However, in order to encourage innovation, product and process oriented research and development should be exempted from the obligation to register for a certain time period where a substance is not yet intended to be placed on the market to an indefinite number of customers because its application in preparations or articles still requires further research and development performed by the potential registrant himself or in cooperation with a limited number of known customers. In addition, it is appropriate to provide for a similar exemption to downstream users 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. ...

... 31. The Commission, in close cooperation with industry, Member States and other relevant stakeholders, should develop guidance to fulfil the requirements under this Regulation related to preparations (in particular with regard to safety data sheets incorporating exposure scenarios) including assessment of substances incorporated into special preparations – such as metals incorporated in alloys. In doing so, the Commission should take full account of the work that will have been carried out within the framework of the RIPs and should include the necessary guidance on this matter in the overall REACH guidance package. This guidance should be available before the application of this Regulation. ...

... 38. The generation of information by alternative means offering equivalence to prescribed tests and test methods should also be allowed, for example when this information comes from valid qualitative or quantitative structure activity models or from structurally related substances. To this end the Agency, in cooperation with Member States and interested parties, should develop appropriate guidance. It should also be possible not to submit certain information if appropriate justification can be provided. Based on experience gained through RIPs, criteria should be developed defining what constitutes such justification. ...

... 63. It is also necessary to ensure that generation of information is tailored to real information needs. To this end evaluation should require the Agency to decide on the programmes of testing proposed by manufacturers and importers. In cooperation with Member States, the Agency should give priority to certain substances, for instance those which may be of very high concern. ...

... 66. The Agency should also be empowered to require further information from manufacturers, importers or downstream users on substances suspected of posing a risk to human health or the environment, including by reason of their presence on the internal market in high volumes, on the basis of evaluations performed. Based on the criteria for prioritising substances developed by the Agency 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. If a risk equivalent to the level of concern arising from the use of substances subject to authorisation arises from the use of isolated intermediates on site, the competent authorities of the Member States should also be allowed to require further information, when justified. ...

... 88. In order to prepare a restrictions proposal and in order for such legislation to operate effectively, there should be good cooperation, coordination and information between the Member States, the Agency, other bodies of the Community, the Commission and the interested parties. ...

... 104. It is necessary to ensure close cooperation between the Agency and the competent authorities working within the Member States so that the scientific opinions of the Committee for Risk Assessment and the Committee for Socio-economic Analysis are based on the broadest possible scientific and technical expertise appropriate which is available within the Community. To the same end, these Committees should be able to rely on additional particular expertise. ...

... 105. In the light of the increased responsibility of natural or legal persons for ensuring safe use of chemicals, enforcement needs to be strengthened. The Agency should therefore provide a Forum for Member States to exchange information on and to coordinate their activities related to the enforcement of chemicals legislation. The currently informal cooperation between Member States in this respect would benefit from a more formal framework. ...

... 109. The Agency should contribute, through cooperation with organisations having interests in the harmonisation of international regulations, to the role of the Community and the Member States in such harmonisation activities. To promote broad international consensus the Agency should take account of existing and emerging international standards in the regulation of chemicals such as the Globally Harmonised System (GHS) of classification and labelling of chemicals. ...

... 111. It is important to avoid confusion between the mission of the Agency and the respective missions of the European Medicines Agency (EMEA) established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency⁽¹³⁾, the European Food Safety Authority (EFSA) established by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety⁽¹⁴⁾ and the Advisory Committee on Safety, Hygiene and Health Protection at Work set up by the Council Decision of 22 July 2003⁽¹⁵⁾. Consequently, the Agency should establish rules of procedure where cooperation with the EFSA or the Advisory Committee on Safety, Hygiene and Health Protection at Work is necessary. This Regulation should otherwise be without prejudice to the competence conferred on the EMEA, the EFSA and the Advisory Committee on Safety, Hygiene and Health Protection at Work by Community legislation. ...

... 119. Apart from their participation in the implementation of Community legislation, Member State competent authorities should, because of their closeness to stakeholders in the Member States, play a role in the exchange of information on risks of substances and on the obligations of natural or legal persons under chemicals legislation. At the same time, close cooperation between the Agency, the Commission and the competent authorities of the Member States is necessary to ensure the coherence and efficiency of the global communication process. ...

... 120. In order for the system established by this Regulation to operate effectively, there should be good cooperation, coordination and exchange of information between the Member States, the Agency and the Commission regarding enforcement. ...

... 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. ...

... 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: ...

... (l) at the Commission's request, providing technical and scientific support for steps to improve cooperation between the Community, its Member States, international organisations and third countries on scientific and technical issues relating to the safety of substances, as well as active participation in technical assistance and capacity building activities on sound management of chemicals in developing countries; ...

... (b) at the Executive Director's request, providing technical and scientific support for steps to improve cooperation between the Community, its Member States, international organisations and third countries on scientific and technical issues relating to the safety of substances, as well as active participation in technical assistance and capacity building activities on sound management of chemicals in developing countries; ...

... 1. The Agency shall cooperate with other Community bodies to ensure mutual support in the accomplishment of their respective tasks in particular to avoid duplication of work. ...

... The Agency shall specify formats and make them available free of charge, and software packages and make them available on its website for any submissions to the Agency. Member States, manufactures, importers, distributors or downstream users shall use these formats and packages in their submissions to the Agency pursuant to this Regulation. In particular, the Agency shall make available software tools to facilitate the submission of all information relating to substances registered in accordance with Article 12(1). For the purposes of registration, the format of the technical dossier referred to in Article 10(a) shall be IUCLID. The Agency shall coordinate the further development of this format with the Organisation for Economic Cooperation and Development to ensure maximum harmonisation. ...

... Cooperation with third countries and international organisations ...

... (a) the purpose of the agreement is cooperation on the implementation or management of legislation concerning chemicals covered by this Regulation; ...

... Cooperation between competent authorities ...

... The competent authorities shall cooperate with each other in the performance of their tasks under this Regulation and shall give the competent authorities of other Member States all the necessary and useful support to this end. ...