Site search

Global links

Sister sites

... 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 the Agency. Registered substances should be allowed to circulate on the internal market. ...

... 25. The responsibility to assess the risks and hazards of substances should be given, in the first place, to the natural or legal persons that manufacture or import substances, but only when they do so in quantities exceeding a certain volume, to enable them to carry the associated burden. Natural or legal persons handling chemicals should take the necessary risk management measures in accordance with the assessment of the risks of substances and pass on relevant recommendations along the supply chain. This should include describing, documenting and notifying in an appropriate and transparent fashion the risks stemming from the production, use and disposal of each substance. ...

... 27. For purposes of enforcement and evaluation and for reasons of transparency, the information on these substances, as well as related information, including on risk management measures, should normally be submitted to authorities. ...

... 92. For reasons of transparency, the Agency should publish the relevant dossier including the suggested restrictions while requesting comments. ...

... 95. The Agency should be central to ensuring that chemicals legislation and the decision-making processes and scientific basis underlying it have credibility with all stakeholders and the public. The Agency should also play a pivotal role in coordinating communication around this Regulation and in its implementation. The confidence in the Agency of the Community institutions, the Member States, the general public and interested parties is therefore essential. For this reason, it is vital to ensure its independence, high scientific, technical and regulatory capacities, as well as transparency and efficiency. ...

... 117. EU-citizens should have access to information about chemicals to which they may be exposed, in order to allow them to make informed decisions about their use of chemicals. A transparent means of achieving this is to grant them free and easy access to basic data held in the Agency's database, including brief profiles of hazardous properties, labelling requirements and relevant Community legislation including authorised uses and risk management measures. The Agency and Member States should allow access to information in accordance with Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information⁽¹⁶⁾, Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents⁽¹⁷⁾ and with the UNECE Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters, to which the European Community is a party. ...

... 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. ...

... 3. The previous registrant and potential registrant(s) shall make every effort to ensure that the costs of sharing the information are determined in a fair, transparent and non-discriminatory way. This may be facilitated by following cost sharing guidance based on those principles which is adopted by the Agency in accordance with Article 77(2)(g). Registrants are only required to share in the costs of information that they are required to submit to satisfy their registration requirements. ...

... 1. Before testing is carried out in order to meet the information requirements for the purposes of registration, a SIEF participant shall inquire whether a relevant study is available by communicating within his SIEF. If a relevant study involving tests on vertebrate animals is available within the SIEF, a participant of that SIEF shall request that study. If a relevant study not involving tests on vertebrate animals is available within the SIEF, a SIEF participant may request that study. Within one month of the request, the owner of the study shall provide proof of its cost to the participant(s) requesting it. The participant(s) and the owner shall make every effort to ensure that the costs of sharing the information are determined in a fair, transparent and non discriminatory way. This may be facilitated by following any cost sharing guidance which is based on those principles and is adopted by the Agency in accordance with Article 77(2)(g). If they cannot reach such an agreement, the cost shall be shared equally. The owner shall give permission to refer to the full study report for the purpose of registration within two weeks of receipt of payment. Registrants are only required to share in the costs of information that they are required to submit to satisfy their registration requirements. ...

... Rules on transparency ...

... To ensure transparency, the Management Board shall, on the basis of a proposal by the Executive Director and in agreement with the Commission, adopt rules to ensure the availability to the public of regulatory, scientific or technical information concerning the safety of substances on their own, in preparations or in articles which is not of a confidential nature. ...