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... 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. ...

... 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. ...

... 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; ...

... 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; ...

... (vi) study summaries of the information derived from the application of Annexes VII to XI; ...

... (vii) robust study summaries of the information derived from the application of Annexes VII to XI, if required under Annex I; ...

... 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. ...

... 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; ...

... (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; ...

... 3. Any study summaries or robust study summaries of studies submitted in the framework of a registration under this Regulation at least 12 years previously can be used for the purposes of registration by another manufacturer or importer. ...

... 3. Any study summaries or robust study summaries of studies submitted in the framework of a registration under this Regulation at least 12 years previously can be used for the purposes of registration by another manufacturer or importer. ...

... 3. If the same substance has previously been registered less than 12 years earlier, the Agency shall inform the potential registrant without delay of the names and addresses of the previous registrant(s) and of the relevant summaries or robust study summaries, as the case may be, already submitted by them. Studies involving vertebrate animals shall not be repeated. The Agency shall simultaneously inform the previous registrants of the name and address of the potential registrant. The available studies shall be shared with the potential registrant in accordance with Article 27. ...

... 3. If the same substance has previously been registered less than 12 years earlier, the Agency shall inform the potential registrant without delay of the names and addresses of the previous registrant(s) and of the relevant summaries or robust study summaries, as the case may be, already submitted by them. Studies involving vertebrate animals shall not be repeated. The Agency shall simultaneously inform the previous registrants of the name and address of the potential registrant. The available studies shall be shared with the potential registrant in accordance with Article 27. ...

... 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. ...

... 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. ...

... (a) a decision requiring the registrant(s) or downstream user(s) concerned to carry out the proposed test and setting a deadline for submission of the study summary, or the robust study summary if required by Annex I; ...

... (a) a decision requiring the registrant(s) or downstream user(s) concerned to carry out the proposed test and setting a deadline for submission of the study summary, or the robust study summary if required by Annex I; ...

... 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. ...

... (c) the study summaries or robust study summaries of the information referred to in paragraph 1(d) and (e); ...

... (c) the study summaries or robust study summaries of the information referred to in paragraph 1(d) and (e); ...