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... 9. The assessment of the operation of the four main legal instruments governing chemicals in the Community, i.e. Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances⁽³⁾, Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations⁽⁴⁾, Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations⁽⁵⁾ and Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances⁽⁶⁾, identified a number of problems in the functioning of Community legislation on chemicals, resulting in disparities between the laws, regulations and administrative provisions in Member States directly affecting the functioning of the internal market in this field, and the need to do more to protect public health and the environment in accordance with the precautionary principle. ...

... 50. It is in the public interest to ensure the quickest possible circulation of test results on human health or environmental hazards of certain substances to those natural or legal persons which use them, in order to limit any risks associated with their use. Sharing of information should occur where this is requested by any registrant, in particular in the case of information involving tests on vertebrate animals, under conditions that ensure a fair compensation for the company that has undertaken the tests. ...

... 65. In addition, it is necessary to instil confidence in the general quality of registrations and to ensure that the public at large as well as all stakeholders in the chemicals industry have confidence that natural or legal persons are meeting the obligations placed upon them. Accordingly, it is appropriate to provide for recording which information has been reviewed by an assessor possessing appropriate experience, and for a percentage of registrations to be checked for compliance by the Agency. ...

... 68. Evaluation may lead to the conclusion that action should be taken under the restriction or authorisation procedures or that risk management action should be considered in the framework of other appropriate legislation. Information on the progress of evaluation proceedings should therefore be made public. ...

... 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. ...

... 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. ...

... 114. To ensure a harmonised protection for the general public, and, in particular, for persons who come into contact with certain substances, and the proper functioning of other Community legislation relying on the classification and labelling, an inventory should record the classification in accordance with Directive 67/548/EEC and Directive 1999/45/EC agreed by manufacturers and importers of the same substance, if possible, as well as decisions taken at Community level to harmonise the classification and labelling of some substances. This should take full account of the work and experience accumulated in connection with the activities under Directive 67/548/EEC, including the classification and labelling of specific substances or groups of substances listed in Annex I of Directive 67/548/EEC. ...

... 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. ...

... 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. ...

... 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. ...

... (a) radioactive substances within the scope of Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation⁽¹⁾; ...

... 4. The Agency may decide to impose conditions with the aim of ensuring that the substance or the preparation or article in which the substance is incorporated will be handled only by staff of listed customers as referred to in paragraph 2(e) in reasonably controlled conditions, in accordance with the requirements of legislation for the protection of workers and the environment, and will not be made available to the general public at any time either on its own or in a preparation or article and that remaining quantities will be re-collected for disposal after the exemption period. In such cases, the Agency may ask the notifier to provide additional necessary information. ...

... 4. The safety data sheet need not be supplied where dangerous substances or preparations offered or sold to the general public are provided with sufficient information to enable users to take the necessary measures as regards the protection of human health, safety and the environment, unless requested by a downstream user or distributor. ...

... 4. Before the Agency sends its recommendation to the Commission it shall make it publicly available on its website, clearly indicating the date of publication, taking into account Articles 118 and 119 on access to information. The Agency shall invite all interested parties to submit comments within three months of the date of publication, in particular on uses which should be exempt from the authorisation requirement. The Agency shall update its recommendation, taking into account the comments received. ...

... 6. The Agency shall determine in accordance with Articles 118 and 119 which parts of its opinions and parts of any attachments thereto should be made publicly available on its website. ...

... 9. Summaries of the Commission decisions, including the authorisation number and the reasons for the decision, in particular where suitable alternatives exist, shall be published in the Official Journal of the European Union and shall be made publicly available in a database established and kept up to date by the Agency. ...

... Holders of an authorisation, as well as downstream users referred to in Article 56(2) including the substances in a preparation, shall include the authorisation number on the label before they place the substance or a preparation containing the substance on the market for an authorised use without prejudice to Directive 67/548/EEC and Directive 1999/45/EC. This shall be done without delay once the authorisation number has been made publicly available in accordance with Article 64(9). ...

... 6. Without prejudice to Articles 118 and 119, the Agency shall make publicly available on its website all dossiers conforming with Annex XV including the restrictions suggested pursuant to paragraphs 3 and 4 of this Article without delay, clearly indicating the date of publication. The Agency shall invite all interested parties to submit individually or jointly within 6 months of the date of publication: ...

... (e) establishing and maintaining database(s) with information on all registered substances, the classification and labelling inventory and the harmonised classification and labelling list. It shall make the information identified in Article 119(1) and (2) in the database(s) publicly available, free of charge, over the Internet, except where a request made under Article 10(a)(xi) is considered justified. The Agency shall make other information in the databases available on request in accordance with Article 118; ...

... (f) making publicly available information as to which substances are being, and have been evaluated within 90 days of receipt of the information at the Agency, in accordance with Article 119(1); ...

... (i) providing guidance to stakeholders including Member State competent authorities on communication to the public of information on the risks and safe use of substances, on their own, in preparations or in articles; ...

... It shall adopt the internal rules and procedures of the Agency. These rules shall be made public. It shall perform its duties in relation to the Agency's budget pursuant to Articles 96, 97 and 103. It shall exercise disciplinary authority over the Executive Director. It shall adopt its rules of procedure. It shall appoint the Chairman, the members and alternates of the Board of Appeal in accordance with Article 89. It shall appoint the members of the Agency committees as set out in Article 85. It shall forward annually any information relevant to the outcome of the evaluation procedures in accordance with Article 96(6). ...

... 1. The membership of the Committees and of the Forum shall be made public. Individual members may request that their names not be made public if they believe that such publication could place them at risk. The Executive Director shall decide whether to agree to such requests. When each appointment is published, the professional qualifications of each member shall be specified. ...

... 1. The membership of the Committees and of the Forum shall be made public. Individual members may request that their names not be made public if they believe that such publication could place them at risk. The Executive Director shall decide whether to agree to such requests. When each appointment is published, the professional qualifications of each member shall be specified. ...

... 2. Members of the Management Board, the Executive Director and members of the Committees and of the Forum shall make a declaration of commitment to fulfil their duties and a declaration of interests which could be considered to be prejudicial to their independence. These declarations shall be made annually in writing and, without prejudice to paragraph 1, be entered in a register held by the Agency which is accessible to the public, on request, at the Agency's offices. ...

... 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. ...

... 1. A classification and labelling inventory, listing the information referred to in Article 113(1), both for information notified under Article 113(1) as well as for information submitted as part of a registration, shall be established and maintained by the Agency in the form of a database. The information in this database identified in Article 119(1) shall be publicly accessible. The Agency shall grant access to the other data on each substance in the inventory to the notifiers and registrants who have submitted information on that substance in accordance with Article 29(1). The Agency shall update the inventory when it receives updated information in accordance with Article 113(3). ...

... Electronic public access ...

... 1. The following information held by the Agency on substances whether on their own, in preparations or in articles, shall be made publicly available, free of charge, over the Internet in accordance with Article 77(2)(e): ...

... 2. The following information on substances whether on their own, in preparations or in articles, shall be made publicly available, free of charge, over the Internet in accordance with Article 77(2)(e) except where a party submitting the information submits a justification in accordance with Article 10(a)(xi), accepted as valid by the Agency, as to why such publication is potentially harmful for the commercial interests of the registrant or any other party concerned: ...

... Communication to the public of information on risks of substances ...

... 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. ...