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... 14. This Regulation will generate information on substances and their uses. Available information, including that generated by this Regulation, should be used by the relevant actors in the application and implementation of appropriate Community legislation, for example that covering products, and Community voluntary instruments, such as the eco-labelling scheme. The Commission should consider in the review and development of relevant Community legislation and voluntary instruments how information generated by this Regulation should be used, and examine possibilities for establishing a European quality mark. ...
... 14. This Regulation will generate information on substances and their uses. Available information, including that generated by this Regulation, should be used by the relevant actors in the application and implementation of appropriate Community legislation, for example that covering products, and Community voluntary instruments, such as the eco-labelling scheme. The Commission should consider in the review and development of relevant Community legislation and voluntary instruments how information generated by this Regulation should be used, and examine possibilities for establishing a European quality mark. ...
... 14. This Regulation will generate information on substances and their uses. Available information, including that generated by this Regulation, should be used by the relevant actors in the application and implementation of appropriate Community legislation, for example that covering products, and Community voluntary instruments, such as the eco-labelling scheme. The Commission should consider in the review and development of relevant Community legislation and voluntary instruments how information generated by this Regulation should be used, and examine possibilities for establishing a European quality mark. ...
... 17. All available and relevant information on substances on their own, in preparations and in articles should be collected to assist in identifying hazardous properties, and recommendations about risk management measures should systematically be conveyed through supply chains, as reasonably necessary, to prevent adverse effects on human health and the environment. In addition, communication of technical advice to support risk management should be encouraged in the supply chain, where appropriate. ...
... 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. Information on the implementation of this Regulation should be easily accessible, in particular for SMEs. ...
... 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. ...
... 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. ...
... 21. Although the information yielded on substances through evaluation should be used in the first place by manufacturers and importers to manage the risks related to their substances, it may also be used to initiate the authorisation or restrictions procedures under this Regulation or risk management procedures under other Community legislation. Therefore it should be ensured that this information is available to the competent authorities and may be used by them for the purpose of such procedures. ...
... 21. Although the information yielded on substances through evaluation should be used in the first place by manufacturers and importers to manage the risks related to their substances, it may also be used to initiate the authorisation or restrictions procedures under this Regulation or risk management procedures under other Community legislation. Therefore it should be ensured that this information is available to the competent authorities and may be used by them for the purpose of such procedures. ...
... 26. In order to undertake chemical safety assessments of substances effectively, manufacturers and importers of substances should obtain information on these substances, if necessary by performing new tests. ...
... 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. ...
... 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. ...
... 33. Joint submission and the sharing of information on substances should be provided for in order to increase the efficiency of the registration system, to reduce costs and to reduce testing on vertebrate animals. One of a group of multiple registrants should submit information on behalf of the others according to rules which ensure that all the required information is submitted, while allowing sharing of the costs burden. A registrant should be able to submit information directly to the Agency in certain specified cases. ...
... 33. Joint submission and the sharing of information on substances should be provided for in order to increase the efficiency of the registration system, to reduce costs and to reduce testing on vertebrate animals. One of a group of multiple registrants should submit information on behalf of the others according to rules which ensure that all the required information is submitted, while allowing sharing of the costs burden. A registrant should be able to submit information directly to the Agency in certain specified cases. ...
... 33. Joint submission and the sharing of information on substances should be provided for in order to increase the efficiency of the registration system, to reduce costs and to reduce testing on vertebrate animals. One of a group of multiple registrants should submit information on behalf of the others according to rules which ensure that all the required information is submitted, while allowing sharing of the costs burden. A registrant should be able to submit information directly to the Agency in certain specified cases. ...
... 33. Joint submission and the sharing of information on substances should be provided for in order to increase the efficiency of the registration system, to reduce costs and to reduce testing on vertebrate animals. One of a group of multiple registrants should submit information on behalf of the others according to rules which ensure that all the required information is submitted, while allowing sharing of the costs burden. A registrant should be able to submit information directly to the Agency in certain specified cases. ...
... 34. Requirements for generation of information on substances should be tiered according to the volumes of manufacture or importation of a substance, because these provide an indication of the potential for exposure of man and the environment to the substances, and should be described in detail. To reduce the possible impact on low volume substances, new toxicological and ecotoxicological information should only be required for priority substances between 1 and 10 tonnes. For other substances in that quantity range there should be incentives to encourage manufacturers and importers to provide this information. ...
... 34. Requirements for generation of information on substances should be tiered according to the volumes of manufacture or importation of a substance, because these provide an indication of the potential for exposure of man and the environment to the substances, and should be described in detail. To reduce the possible impact on low volume substances, new toxicological and ecotoxicological information should only be required for priority substances between 1 and 10 tonnes. For other substances in that quantity range there should be incentives to encourage manufacturers and importers to provide this information. ...
... 34. Requirements for generation of information on substances should be tiered according to the volumes of manufacture or importation of a substance, because these provide an indication of the potential for exposure of man and the environment to the substances, and should be described in detail. To reduce the possible impact on low volume substances, new toxicological and ecotoxicological information should only be required for priority substances between 1 and 10 tonnes. For other substances in that quantity range there should be incentives to encourage manufacturers and importers to provide this information. ...
... 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. ...
... 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. ...
... 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. ...
... 46. To ensure that the information gathered through the registration is kept up-to-date, an obligation on registrants to inform the Agency of certain changes to the information should be introduced. ...
... 46. To ensure that the information gathered through the registration is kept up-to-date, an obligation on registrants to inform the Agency of certain changes to the information should be introduced. ...
... 47. In accordance with Directive 86/609/EEC, 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 the Agency as appropriate to meet the information requirements under this Regulation. To this end, the Commission, following consultation with relevant stakeholders, should propose to amend the future Commission Regulation on test methods or this Regulation, where appropriate, to replace, reduce or refine animal testing. The Commission and the Agency should ensure that reduction of animal testing is a key consideration in the development and maintenance of guidance for stakeholders and in the Agency's own procedures. ...
... 49. In order to avoid duplication of work, and in particular to reduce testing involving vertebrate animals, the provisions concerning preparation and submission of registrations and updates should require sharing of information where this is requested by any registrant. If the information concerns vertebrate animals, the registrant should be obliged to request it. ...
... 49. In order to avoid duplication of work, and in particular to reduce testing involving vertebrate animals, the provisions concerning preparation and submission of registrations and updates should require sharing of information where this is requested by any registrant. If the information concerns vertebrate animals, the registrant should be obliged to request it. ...
... 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. ...
... 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. ...
... 53. In order to allow a potential registrant of a phase-in substance to proceed with his registration, even if he cannot reach agreement with a previous registrant, the Agency, on request, should allow use of any summary or robust study summary of tests already submitted. The registrant who receives these data should be obliged to pay a contribution to the costs to the owner of the data. For non-phase-in substances, the Agency may ask for evidence that a potential registrant has paid the owner of a study before the Agency gives permission for the potential registrant to use that information in his registration. ...
... 54. In order to avoid duplication of work, and in particular to avoid duplication of testing, registrants of phase-in substances should pre-register as early as possible with a database managed by the Agency. A system should be established in order to provide for the establishment of Substance Information Exchange Fora (SIEF) to help exchange of information on the substances that have been registered. SIEF participants should include all relevant actors submitting information to the Agency on the same phase-in substance. They should include both potential registrants, who must provide and be supplied with any information relevant to the registration of their substances, and other participants, who may receive financial compensation for studies they hold but are not entitled to request information. In order to ensure the smooth functioning of that system they should fulfil certain obligations. If a member of a SIEF does not fulfil his obligations, he should be penalised accordingly but other members should be enabled to continue preparing their own registration. In cases where a substance has not been pre-registered, measures should be taken to help downstream users find alternative sources of supply. ...
... 54. In order to avoid duplication of work, and in particular to avoid duplication of testing, registrants of phase-in substances should pre-register as early as possible with a database managed by the Agency. A system should be established in order to provide for the establishment of Substance Information Exchange Fora (SIEF) to help exchange of information on the substances that have been registered. SIEF participants should include all relevant actors submitting information to the Agency on the same phase-in substance. They should include both potential registrants, who must provide and be supplied with any information relevant to the registration of their substances, and other participants, who may receive financial compensation for studies they hold but are not entitled to request information. In order to ensure the smooth functioning of that system they should fulfil certain obligations. If a member of a SIEF does not fulfil his obligations, he should be penalised accordingly but other members should be enabled to continue preparing their own registration. In cases where a substance has not been pre-registered, measures should be taken to help downstream users find alternative sources of supply. ...
... 54. In order to avoid duplication of work, and in particular to avoid duplication of testing, registrants of phase-in substances should pre-register as early as possible with a database managed by the Agency. A system should be established in order to provide for the establishment of Substance Information Exchange Fora (SIEF) to help exchange of information on the substances that have been registered. SIEF participants should include all relevant actors submitting information to the Agency on the same phase-in substance. They should include both potential registrants, who must provide and be supplied with any information relevant to the registration of their substances, and other participants, who may receive financial compensation for studies they hold but are not entitled to request information. In order to ensure the smooth functioning of that system they should fulfil certain obligations. If a member of a SIEF does not fulfil his obligations, he should be penalised accordingly but other members should be enabled to continue preparing their own registration. In cases where a substance has not been pre-registered, measures should be taken to help downstream users find alternative sources of supply. ...
... 54. In order to avoid duplication of work, and in particular to avoid duplication of testing, registrants of phase-in substances should pre-register as early as possible with a database managed by the Agency. A system should be established in order to provide for the establishment of Substance Information Exchange Fora (SIEF) to help exchange of information on the substances that have been registered. SIEF participants should include all relevant actors submitting information to the Agency on the same phase-in substance. They should include both potential registrants, who must provide and be supplied with any information relevant to the registration of their substances, and other participants, who may receive financial compensation for studies they hold but are not entitled to request information. In order to ensure the smooth functioning of that system they should fulfil certain obligations. If a member of a SIEF does not fulfil his obligations, he should be penalised accordingly but other members should be enabled to continue preparing their own registration. In cases where a substance has not been pre-registered, measures should be taken to help downstream users find alternative sources of supply. ...
... 54. In order to avoid duplication of work, and in particular to avoid duplication of testing, registrants of phase-in substances should pre-register as early as possible with a database managed by the Agency. A system should be established in order to provide for the establishment of Substance Information Exchange Fora (SIEF) to help exchange of information on the substances that have been registered. SIEF participants should include all relevant actors submitting information to the Agency on the same phase-in substance. They should include both potential registrants, who must provide and be supplied with any information relevant to the registration of their substances, and other participants, who may receive financial compensation for studies they hold but are not entitled to request information. In order to ensure the smooth functioning of that system they should fulfil certain obligations. If a member of a SIEF does not fulfil his obligations, he should be penalised accordingly but other members should be enabled to continue preparing their own registration. In cases where a substance has not been pre-registered, measures should be taken to help downstream users find alternative sources of supply. ...
... 55. Manufacturers and importers of a substance on its own or in a preparation should be encouraged to communicate with the downstream users of the substance with regard to whether they intend to register the substance. Such information should be provided to a downstream user sufficiently in advance of the relevant registration deadline if the manufacturer or importer does not intend to register the substance, in order to enable the downstream user to look for alternative sources of supply. ...
... 56. Part of the responsibility of manufacturers or importers for the management of the risks of substances is the communication of information on these substances to other professionals such as downstream users or distributors. In addition, producers or importers of articles should supply information on the safe use of articles to industrial and professional users, and consumers on request. This important responsibility should also apply throughout the supply chain to enable all actors to meet their responsibility in relation to management of risks arising from the use of substances. ...
... 56. Part of the responsibility of manufacturers or importers for the management of the risks of substances is the communication of information on these substances to other professionals such as downstream users or distributors. In addition, producers or importers of articles should supply information on the safe use of articles to industrial and professional users, and consumers on request. This important responsibility should also apply throughout the supply chain to enable all actors to meet their responsibility in relation to management of risks arising from the use of substances. ...
... 58. In order to have a chain of responsibilities, downstream users should be responsible for assessing the risks arising from their uses of substances if those uses are not covered by a safety data sheet received from their suppliers, unless the downstream user concerned takes more protective measures than those recommended by his supplier or unless his supplier was not required to assess those risks or provide him with information on those risks. For the same reason, downstream users should manage the risks arising from their uses of substances. In addition, it is appropriate that any producer or importer of an article containing a substance of very high concern should provide sufficient information to allow safe use of such an article. ...
... 58. In order to have a chain of responsibilities, downstream users should be responsible for assessing the risks arising from their uses of substances if those uses are not covered by a safety data sheet received from their suppliers, unless the downstream user concerned takes more protective measures than those recommended by his supplier or unless his supplier was not required to assess those risks or provide him with information on those risks. For the same reason, downstream users should manage the risks arising from their uses of substances. In addition, it is appropriate that any producer or importer of an article containing a substance of very high concern should provide sufficient information to allow safe use of such an article. ...
... 59. The requirements for undertaking chemical safety assessments by downstream users should also be prescribed in detail to allow them to meet their obligations. These requirements should only apply above a total quantity of 1 tonne of substance or preparation. In any case, however, the downstream users should consider the use and identify and apply appropriate risk management measures. Downstream users should report certain basic information on use to the Agency. ...
... 60. For enforcement and evaluation purposes, downstream users of substances should be required to report to the Agency certain basic information if their use is outside the conditions of the exposure scenario detailed in the safety data sheet communicated by their original manufacturer or importer and to keep such reported information up-to-date. ...
... 60. For enforcement and evaluation purposes, downstream users of substances should be required to report to the Agency certain basic information if their use is outside the conditions of the exposure scenario detailed in the safety data sheet communicated by their original manufacturer or importer and to keep such reported information up-to-date. ...
... 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. ...
... 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. ...
... 64. In order to prevent unnecessary animal testing, interested parties should have a period of 45 days during which they may provide scientifically valid information and studies that address the relevant substance and hazard end-point, which is addressed by the testing proposal. The scientifically valid information and studies received by the Agency should be taken into account for decisions on testing proposals. ...
... 64. In order to prevent unnecessary animal testing, interested parties should have a period of 45 days during which they may provide scientifically valid information and studies that address the relevant substance and hazard end-point, which is addressed by the testing proposal. The scientifically valid information and studies received by the Agency should be taken into account for decisions on testing proposals. ...
... 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. ...
... 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. ...
... 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. ...
... 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. ...
... 72. To support the aim of eventual replacement of substances of very high concern by suitable alternative substances or technologies, all applicants for authorisation should provide an analysis of alternatives considering their risks and the technical and economic feasibility of substitution, including information on any research and development the applicant is undertaking or intends to undertake. Furthermore, authorisations should be subject to time-limited review whose periods would be determined on a case-by-case basis and normally be subject to conditions, including monitoring. ...
... 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. ...
... 97. The effective communication of information on chemical risks and how they can be managed is an essential part of the system established by this Regulation. Best practice from the chemicals and other sectors should be considered in the preparation of guidance by the Agency to all stakeholders. ...
... 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. ...
... 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. ...
... 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. ...
... 118. Disclosure of information under this Regulation is subject to the specific requirements of Regulation (EC) No 1049/2001. That Regulation sets binding deadlines for the release of information as well as procedural guarantees, including the right of appeal. The Management Board should adopt the practical arrangements for application of those requirements to the Agency. ...
... 118. Disclosure of information under this Regulation is subject to the specific requirements of Regulation (EC) No 1049/2001. That Regulation sets binding deadlines for the release of information as well as procedural guarantees, including the right of appeal. The Management Board should adopt the practical arrangements for application of those requirements to the Agency. ...