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... 30. The requirements for undertaking chemical safety assessments by manufacturers and importers should be defined in detail in a technical annex to allow them to meet their obligations. To achieve fair burden sharing with their customers, manufacturers and importers should in their chemical safety assessment address not only their own uses and the uses for which they place their substances on the market, but also all uses which their customers ask them to address. ...
... 30. The requirements for undertaking chemical safety assessments by manufacturers and importers should be defined in detail in a technical annex to allow them to meet their obligations. To achieve fair burden sharing with their customers, manufacturers and importers should in their chemical safety assessment address not only their own uses and the uses for which they place their substances on the market, but also all uses which their customers ask them to address. ...
... 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. ...
... 76. Experience at international level shows that substances with characteristics rendering them persistent, liable to bioaccumulate and toxic, or very persistent and very liable to bioaccumulate, present a very high concern, while criteria have been developed allowing the identification of such substances. For certain other substances concerns are sufficiently high to address them in the same way on a case-by-case basis. The criteria in Annex XIII should be reviewed taking into account the current and any new experience in the identification of these substances and if appropriate, be amended with a view to ensuring a high level of protection for human health and the environment. ...
... 89. In order to give Member States the opportunity to submit proposals to address a specific risk for human health and the environment, they should prepare a dossier in conformity with detailed requirements. The dossier should set out the justification for Community-wide action. ...
... 91. In order to give the Commission the opportunity to address a specific risk for human health and the environment that needs to be addressed Community wide, it should be able to entrust the Agency with the preparation of a restriction dossier. ...
... 129. For the sake of consistency, Directive 1999/45/EC which already addresses matters covered by this Regulation should be amended. ...
ARTICLE-9: Exemption from the general obligation to register for product and process orientated research and development (PPORD) [go to this ARTICLE]
ARTICLE-14: Chemical safety report and duty to apply and recommend risk reduction measures [go to this ARTICLE]
... The exposure scenarios (where appropriate the use and exposure categories), exposure assessment and risk characterisation shall address all identified uses of the registrant. ...
ARTICLE-22: Further duties of registrants [go to this ARTICLE]
... (a) any change in his status, such as being a manufacturer, an importer or a producer of articles, or in his identity, such as his name or address; ...
ARTICLE-26: Duty to inquire prior to registration [go to this ARTICLE]
... 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. ...
... 4. If several potential registrants have made an inquiry in respect of the same substance, the Agency shall inform all potential registrants without delay of the name and address of the other potential registrants. ...
ARTICLE-27: Sharing of existing data in the case of registered substances [go to this ARTICLE]
... 5. If there is failure to reach such an agreement, the potential registrant(s) shall inform the Agency and the previous registrant(s) thereof at the earliest one month after receipt, from the Agency, of the name and address of the previous registrant(s). ...
ARTICLE-28: Duty to pre-register for phase-in substances [go to this ARTICLE]
... (b) his name and address and the name of the contact person and, where appropriate, the name and address of the person representing him in accordance with Article 4 as specified in section 1 of Annex VI; ...
... (b) his name and address and the name of the contact person and, where appropriate, the name and address of the person representing him in accordance with Article 4 as specified in section 1 of Annex VI; ...
ARTICLE-40: Examination of testing proposals [go to this ARTICLE]
... 2. Information relating to testing proposals involving tests on vertebrate animals shall be published on the Agency website. The Agency shall publish on its website the name of the substance, the hazard end-point for which vertebrate testing is proposed, and the date by which any third party information is required. It shall invite third parties to submit, using the format provided by the Agency, scientifically valid information and studies that address the relevant substance and hazard end-point, addressed by the testing proposal, within 45 days of the date of publication. All such scientifically valid information and studies received shall be taken into account by the Agency in preparing its decision in accordance with paragraph 3. ...
ARTICLE-49: Further information on on-site isolated intermediates [go to this ARTICLE]
... (b) examine any information submitted and, if necessary, recommend any appropriate risk reduction measures to address the risks identified in relation to the site in question. ...