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... 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. ...

... 35. The Member States, the Agency and all interested parties should take full account of the results of the RIPs, in particular with regard to the registration of substances which occur in nature. ...

... 36. It is necessary to consider the application of Article 2(7)(a) and (b) and Annex XI to substances derived from mineralogical processes and the review of Annexes IV and V should fully take this into account. ...

... 48. This Regulation should be without prejudice to the full and complete application of the Community competition rules. ...

... 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. ...

... 125. It is essential that chemicals be regulated in an effective and timely manner during the transition to full applicability of the provisions of this Regulation and, in particular, during the start-up period of the Agency. Provision should therefore be made for the Commission to provide the necessary support towards the setting up of the Agency, including the conclusion of contracts and the appointment of an Executive Director ad interim until the Agency's Management Board can appoint an Executive Director itself. ...

... 126. To take full advantage of the work performed under Regulation (EEC) No 793/93 as well as under Directive 76/769/EEC and to avoid such work being lost, the Commission should be empowered during the start-up period to initiate restrictions based on that work without following the full restrictions procedure laid down in this Regulation. All those elements should be used, as soon as this Regulation enters into force, to support risk reduction measures. ...

... 126. To take full advantage of the work performed under Regulation (EEC) No 793/93 as well as under Directive 76/769/EEC and to avoid such work being lost, the Commission should be empowered during the start-up period to initiate restrictions based on that work without following the full restrictions procedure laid down in this Regulation. All those elements should be used, as soon as this Regulation enters into force, to support risk reduction measures. ...

... 131. The Regulation observes the fundamental rights and principles which are acknowledged in particular in the Charter of Fundamental Rights of the European Union⁽²⁴⁾. In particular, it seeks to ensure full compliance with the principles of environmental protection and sustainable development guaranteed by Article 37 of that Charter, ...

... 27) Full study report: means a complete and comprehensive description of the activity performed to generate the information. This covers the complete scientific paper as published in the literature describing the study performed or the full report prepared by the test house describing the study performed; ...

... 27) Full study report: means a complete and comprehensive description of the activity performed to generate the information. This covers the complete scientific paper as published in the literature describing the study performed or the full report prepared by the test house describing the study performed; ...

... 28) Robust study summary: means a detailed summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an independent assessment of the study minimising the need to consult the full study report; ...

... 28) Robust study summary: means a detailed summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an independent assessment of the study minimising the need to consult the full study report; ...

... 29) Study summary: means a summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an assessment of the relevance of the study; ...

... Any manufacturer, importer, or where relevant downstream user, may, whilst retaining full responsibility for complying with his obligations under this Regulation, appoint a third party representative for all proceedings under Article 11, Article 19, Title III and Article 53 involving discussions with other manufacturers, importers, or where relevant downstream users. In these cases, the identity of a manufacturer or importer or downstream user who has appointed a representative shall not normally be disclosed by the Agency to other manufacturers, importers, or, where relevant, downstream users. ...

... Except in cases covered under Article 25(3), Article 27(6) or Article 30(3), the registrant shall be in legitimate possession of or have permission to refer to the full study report summarised under (vi) and (vii) for the purpose of registration; ...

... 5. If a substance has already been registered, a new registrant shall be entitled to refer to the study summaries or robust study summaries, for the same substance submitted earlier, provided that he can show that the substance that he is now registering is the same as the one previously registered, including the degree of purity and the nature of impurities, and that the previous registrant(s) have given permission to refer to the full study reports for the purpose of registration. A new registrant shall not refer to such studies in order to provide the information required in section 2 of Annex VI. ...

... (d) any available existing information on physicochemical, human health or environmental properties of the intermediate. Where a full study report is available, a study summary shall be submitted; ...

... Except in cases covered under Article 25(3), Article 27(6) or Article 30(3), the registrant shall be in legitimate possession of or have permission to refer to the full study report summarised under (d) for the purpose of registration. The registration shall be accompanied by the fee required in accordance with Title IX. ...

... (d) any available existing information on physicochemical, human health or environmental properties of the intermediate. Where a full study report is available, a study summary shall be submitted; ...

... Except in cases covered under Article 25(3), Article 27(6) or Article 30(3), the registrant shall be in legitimate possession of or have permission to refer to the full study report summarised under (d) for the purpose of registration. The registration shall be accompanied by the fee required in accordance with Title IX. ...

... 4. On agreement on the sharing of the information, the previous registrant shall make available to the new registrant the agreed information and shall give the new registrant the permission to refer to the previous registrant's full study report. ...

... 6. Within one month from the receipt of the information referred to in paragraph 5, the Agency shall give the potential registrant permission to refer to the information requested by him in his registration dossier, subject to the potential registrant providing, upon request by the Agency, proof that he has paid the previous registrant(s) for that information a share of cost incurred. The previous registrant(s) shall have a claim on the potential registrant for a proportionate share of the cost incurred by him. Calculation of the proportionate share may be facilitated by the guidance adopted by the Agency in accordance with Article 77(2)(g). Provided he makes the full study report available to the potential registrant, the previous registrant(s) shall have a claim on the potential registrant for an equal share of the cost incurred by him, which shall be enforceable in the national courts. ...

... 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. ...

... 2. If a relevant study involving tests is not available within the SIEF, only one study shall be conducted per information requirement within each SIEF by one of its participants acting on behalf of the others. They shall take all reasonable steps to reach an agreement within a deadline set by the Agency as to who is to carry out the test on behalf of the other participants and to submit a summary or robust study summary to the Agency. If no agreement is reached, the Agency shall specify which registrant or downstream user shall perform the test. All participants of the SIEF who require a study shall contribute to the costs for the elaboration of the study with a share corresponding to the number of participating potential registrants. Those participants that do not carry out the study themselves shall have the right to receive the full study report within two weeks following payment to the participant that carried out the study. ...

... 3. If the owner of a study as referred to in paragraph 1 which involves testing on vertebrate animals refuses to provide either proof of the cost of that study or the study itself to (an)other participant(s), he shall not be able to proceed with registration until he provides the information to the other participants(s). The other participant(s) shall proceed with registration without fulfilling the relevant information requirement, explaining the reason for this in the registration dossier. The study shall not be repeated unless within 12 months of the date of registration of the other participant(s), the owner of this information has not provided it to them and the Agency decides that the test should be repeated by them. However, if a registration containing this information has already been submitted by another registrant, the Agency shall give the other participant(s) permission to refer to the information in his registration dossier(s). The other registrant shall have a claim on the other participant(s) for an equal share of the cost, provided he makes the full study report available to the other participant(s), which shall be enforceable in the national courts. ...

... 3. In the case referred to in paragraph 1, the registrant or downstream user who performs the test shall provide each of the others concerned with a copy of the full study report. ...

... 4. The person performing and submitting the study shall have a claim against the others accordingly. Any person concerned shall be able to make a claim in order to prohibit another person from manufacturing, importing or placing the substance on the market if that other person either fails to pay his share of the cost or to provide security for that amount or fails to hand over a copy of the full study report of the study performed. All claims shall be enforceable in the national courts. Any person may choose to submit their claims for remuneration to an arbitration board and accept the arbitration order. ...

... 2. A fee need not be paid for a registration of a substance in a quantity of between 1 and 10 tonnes where the registration dossier contains the full information in Annex VII. ...

... (a) details of the full composition of a preparation; ...

... 3. The Management Board shall adopt the practical arrangements for implementing Regulation (EC) No 1049/2001, including appeals or remedies necessary for reviewing a partial or full rejection of a confidentiality request, by 1 June 2008. ...

... Competent authorities shall submit electronically to the Agency any available information that they hold on substances registered in accordance with Article 12(1) whose dossiers do not contain the full information referred to in Annex VII, in particular whether enforcement or monitoring activities have identified suspicions of risk. The competent authority shall update this information as appropriate. Member States shall establish national helpdesks to provide advice to manufacturers, importers, downstream users and any other interested parties on their respective responsibilities and obligations under this Regulation, in particular in relation to the registration of substances in accordance with Article 12(1), in addition to the operational guidance documents provided by the Agency under Article 77(2)(g). ...