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... 8. Special account should be taken of the potential impact of this Regulation on small- and medium-sized enterprises (SMEs) and the need to avoid any discrimination against them. ...
... 28. Scientific research and development normally takes place in quantities below 1 tonne per year. There is no need to exempt such research and development because substances in those quantities do not have to be registered in any case. However, in order to encourage innovation, product and process oriented research and development should be exempted from the obligation to register for a certain time period where a substance is not yet intended to be placed on the market to an indefinite number of customers because its application in preparations or articles still requires further research and development performed by the potential registrant himself or in cooperation with a limited number of known customers. In addition, it is appropriate to provide for a similar exemption to downstream users using the substance for the purposes of product and process oriented research and development, provided that the risks to human health and the environment are adequately controlled in accordance with the requirements of legislation for the protection of workers and the environment. ...
... 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. ...
... 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. ...
... 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. ...
ARTICLE-26: Duty to inquire prior to registration [go to this ARTICLE]
... 1. Every potential registrant of a non-phase-in substance, or potential registrant of a phase-in substance who has not pre-registered in accordance with Article 28, shall inquire from the Agency whether a registration has already been submitted for the same substance. He shall submit all the following information to the Agency with the inquiry: ...
... 1. Every potential registrant of a non-phase-in substance, or potential registrant of a phase-in substance who has not pre-registered in accordance with Article 28, shall inquire from the Agency whether a registration has already been submitted for the same substance. He shall submit all the following information to the Agency with the inquiry: ...
... 2. If the same substance has previously not been registered, the Agency shall inform the potential registrant accordingly. ...
... 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. ...
... 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. ...
... 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. ...
... 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]
... 1. Where a substance has previously been registered less than 12 years earlier as referred to in Article 26(3), the potential registrant: ...
... 2. When a request for information has been made according to paragraph 1, the potential and the previous registrant(s) as referred to in paragraph 1 shall make every effort to reach an agreement on the sharing of the information requested by the potential registrant(s) with respect to Article 10(a)(vi) and (vii). Such an agreement may be replaced by submission of the matter to an arbitration board and acceptance of the arbitration order. ...
... 2. When a request for information has been made according to paragraph 1, the potential and the previous registrant(s) as referred to in paragraph 1 shall make every effort to reach an agreement on the sharing of the information requested by the potential registrant(s) with respect to Article 10(a)(vi) and (vii). Such an agreement may be replaced by submission of the matter to an arbitration board and acceptance of the arbitration order. ...
... 3. The previous registrant and potential registrant(s) 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 cost sharing guidance based on those principles which is adopted by the Agency in accordance with Article 77(2)(g). Registrants are only required to share in the costs of information that they are required to submit to satisfy their registration requirements. ...
... 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). ...
... 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. ...
... 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. ...
... 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. ...
... 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. ...
... 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. ...
ARTICLE-28: Duty to pre-register for phase-in substances [go to this ARTICLE]
... 1. In order to benefit from the transitional regime provided for in Article 23 each potential registrant of a phase-in substance in quantities of 1 tonne or more per year, including without limitation intermediates, shall submit all the following information to the Agency: ...
... 5. After the publication of the list a downstream user of a substance not appearing on the list may notify the Agency of his interest in the substance, his contact details and the details of his current supplier. The Agency shall publish on its website the name of the substance and on request provide contact details of the downstream user to a potential registrant. ...
... 6. Potential registrants who manufacture or import for the first time a phase-in substance in quantities of 1 tonne or more per year or use for the first time a phase-in substance in the context of production of articles or import for the first time an article containing a phase-in substance that would require registration, after 1 December 2008, shall be entitled to rely on Article 23 provided that they submit the information referred to in paragraph 1 of this Article to the Agency within six months of first manufacturing, importing or using the substance in quantities of 1 tonne or more per year and no later than 12 months before the relevant deadline in Article 23. ...
ARTICLE-29: Substance Information Exchange Fora [go to this ARTICLE]
... 1. All potential registrants, downstream users and third parties who have submitted information to the Agency in accordance with Article 28, or whose information is held by the Agency in accordance with Article 15, for the same phase-in substance, or registrants who have submitted a registration for that phase-in substance before the deadline set out in Article 23(3), shall be participants in a substance information exchange forum (SIEF). ...
... (a) facilitate, for the purposes of registration, the exchange of the information specified in Article 10(a) (vi) and (vii) between potential registrants, thereby avoiding the duplication of studies; and ...
... (b) agree classification and labelling where there is a difference in the classification and labelling of the substance between potential registrants. ...
ARTICLE-30: Sharing of data involving tests [go to this ARTICLE]
... 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. ...
ARTICLE-50: Registrants' and downstream users' rights [go to this ARTICLE]
... (a) where the competent authority prepares a dossier in accordance with Annex XV concluding that there is a potential long-term risk to human health or the environment justifying the need for further information; ...
ARTICLE-54: Publication of information on evaluation [go to this ARTICLE]
... By 28 February of each year, the Agency shall publish on its website a report on the progress made over the previous calendar year towards discharging the obligations incumbent upon it in relation to evaluation. This report shall include, in particular, recommendations to potential registrants in order to improve the quality of future registrations. ...
ARTICLE-76: Composition [go to this ARTICLE]
... (e) a Member State Committee, which shall be responsible for resolving potential divergences of opinions on draft decisions proposed by the Agency or the Member States under Title VI and proposals for identification of substances of very high concern to be subjected to the authorisation procedure under Title VII; (f) a Forum for Exchange of Information on Enforcement (hereinafter referred to as "the Forum") which shall coordinate a network of Member States authorities responsible for enforcement of this Regulation; ...
ARTICLE-87: Rapporteurs of Committees and use of experts [go to this ARTICLE]
... 1. Where, in accordance with Article 77, a Committee is required to provide an opinion or consider whether a Member State dossier conforms with the requirements of Annex XV, it shall appoint one of its members as a rapporteur. The Committee concerned may appoint a second member to act as co-rapporteur. For each case, rapporteurs and co-rapporteurs shall undertake to act in the interests of the Community and shall make a declaration of commitment to fulfil their duties and a declaration of interests in writing. A member of a Committee shall not be appointed rapporteur for a particular case if he indicates any interest that might be prejudicial to the independent consideration of that case. The Committee concerned may replace the rapporteur or co-rapporteur by another one of its members at any time, if, for example, they are unable to fulfil their duties within the prescribed time limits, or if a potentially prejudicial interest comes to light. ...
... 4. The provision of services for which there are several potential providers may require a call for an expression of interest: ...
ARTICLE-95: Conflicts of opinion with other bodies [go to this ARTICLE]
... 1. The Agency shall take care to ensure early identification of potential sources of conflict between its opinions and those of other bodies established under Community law, including Community Agencies, carrying out a similar task in relation to issues of common concern. ...
... 2. Where the Agency identifies a potential source of conflict, it shall contact the body concerned in order to ensure that any relevant scientific or technical information is shared and to identify the scientific or technical points which are potentially contentious. ...
... 2. Where the Agency identifies a potential source of conflict, it shall contact the body concerned in order to ensure that any relevant scientific or technical information is shared and to identify the scientific or technical points which are potentially contentious. ...
ARTICLE-119: Electronic public access [go to this ARTICLE]
... 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: ...