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... 42. To avoid overloading authorities and natural or legal persons with the work arising from the registration of phase-in substances already on the internal market, that registration should be spread over an appropriate period of time, without introducing undue delay. Deadlines for the registration of these substances should therefore be set. ...

... 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. ...

... 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. ...

... 20) Phase-in substance: means a substance which meets at least one of the following criteria: ...

... 30) Per year: means per calendar year, unless stated otherwise, for phase-in substances that have been imported or manufactured for at least three consecutive years, quantities per year shall be calculated on the basis of the average production or import volumes for the three preceding calendar years; ...

... (a) the information specified in Annex VII for non-phase-in substances, and for phase-in substances meeting one or both of the criteria specified in Annex III, manufactured or imported in quantities of 1 tonne or more per year per manufacturer or importer; ...

... (a) the information specified in Annex VII for non-phase-in substances, and for phase-in substances meeting one or both of the criteria specified in Annex III, manufactured or imported in quantities of 1 tonne or more per year per manufacturer or importer; ...

... (b) the information on physicochemical properties specified in Annex VII, section 7 for phase-in substances manufactured or imported in quantities of 1 tonne or more per year per manufacturer or importer which do not meet either of the criteria specified in Annex III; ...

... 2. The Agency shall undertake a completeness check of each registration in order to ascertain that all the elements required under Articles 10 and 12 or under Articles 17 or 18, as well as the registration fee referred to in Article 6(4), Article 7(1) and (5), Article 17(2) or Article 18(2), have been provided. The completeness check shall not include an assessment of the quality or the adequacy of any data or justifications submitted. The Agency shall undertake the completeness check within three weeks of the submission date, or within three months of the relevant deadline of Article 23, as regards registrations of phase-in substances submitted in the course of the two-month period immediately preceding that deadline. If a registration is incomplete, the Agency shall inform the registrant, before expiry of the three-week or three-month period referred to in the second subparagraph, as to what further information is required in order for the registration to be complete, while setting a reasonable deadline for this. The registrant shall complete his registration and submit it to the Agency within the deadline set. The Agency shall confirm the submission date of the further information to the registrant. The Agency shall perform a further completeness check, considering the further information submitted. The Agency shall reject the registration if the registrant fails to complete his registration within the deadline set. The registration fee shall not be reimbursed in such cases. ...

... 1. A registrant may start or continue the manufacture or import of a substance or production or import of an article, if there is no indication to the contrary from the Agency in accordance with Article 20(2) within the three weeks after the submission date, without prejudice to Article 27(8). In the case of registrations of phase-in substances, such a registrant may continue the manufacture or import of the substance or production or import of an article, if there is no indication to the contrary from the Agency in accordance with Article 20(2) within the three weeks after the submission date or, if submitted within the two-month period before the relevant deadline of Article 23, if there is no indication to the contrary from the Agency in accordance with Article 20(2) within the three months from that deadline, without prejudice to Article 27(8). In the case of an update of a registration according to Article 22 a registrant may continue the manufacture or import of the substance, or the production or import of the article, if there is no indication to the contrary from the Agency in accordance with Article 20(2) within the three weeks after the update date, without prejudice to Article 27(8). ...

... Specific provisions for phase-in substances ...

... (a) phase-in substances classified as carcinogenic, mutagenic or toxic to reproduction, category 1 or 2, in accordance with Directive 67/548/EEC and manufactured in the Community or imported, in quantities reaching 1 tonne or more per year per manufacturer or per importer, at least once after 1 June 2007; ...

... (b) phase-in substances classified as very toxic to aquatic organisms which may cause long-term adverse effects in the aquatic environment (R50/53) in accordance with Directive 67/548/EEC, and manufactured in the Community or imported in quantities reaching 100 tonnes or more per year per manufacturer or per importer, at least once after 1 June 2007; ...

... (c) phase-in substances manufactured in the Community or imported, in quantities reaching 1 000 tonnes or more per year per manufacturer or per importer, at least once after 1 June 2007. ...

... 2. Article 5, Article 6, Article 7(1), Article 17, Article 18 and Article 21 shall not apply until 1 June 2013 to phase-in substances manufactured in the Community or imported, in quantities reaching 100 tonnes or more per year per manufacturer or per importer, at least once after 1 June 2007. ...

... 3. Article 5, Article 6, Article 7(1), Article 17, Article 18 and Article 21 shall not apply until 1 June 2018 to phase-in substances manufactured in the Community or imported, in quantities reaching 1 tonne or more per year per manufacturer or per importer, at least once after 1 June 2007. ...

... 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: ...

... Duty to pre-register for phase-in substances ...

... 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: ...

... 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. ...

... 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. ...

... 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. ...

... 7. Manufacturers or importers of phase-in substances in quantities of less than 1 tonne per year that appear on the list published by the Agency in accordance with paragraph 4 of this Article, as well as downstream users of those substances and third parties holding information on those substances, may submit the information referred to in paragraph 1 of this Article or any other relevant information to the Agency for those substances, with the intention of being part of the substance information exchange forum as referred to in Article 29. ...

... 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). ...

... 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). ...

... 3. For registered substances, the manufacturer, importer or downstream user shall comply with the obligations laid down in Article 14 either before he next supplies the substance on its own or in a preparation to the downstream user making the request referred to in paragraph 2 of this Article, provided that the request was made at least one month before the supply, or within one month after the request, whichever is the later. For phase-in substances, the manufacturer, importer or downstream user shall comply with this request and with the obligations laid down in Article 14 before the relevant deadline in Article 23 has expired, provided that the downstream user makes his request at least 12 months before the deadline in question. Where the manufacturer, importer or downstream user, having assessed the use in accordance with Article 14, is unable to include it as an identified use for reasons of protection of human health or the environment, he shall provide the Agency and the downstream user with the reason(s) for that decision in writing without delay and shall not supply downstream user(s) with the substance without including these reason(s) in the information referred to under Articles 31 or 32. The manufacturer or importer shall include this use in section 3.7 of Annex VI in his update of the registration in accordance with Article 22(1)(d). ...

... 1. In the case of non phase-in substances, the Agency shall prepare a draft decision in accordance with Article 40(3) within 180 days of receiving a registration or downstream user report containing a testing proposal. ...

... 2. In the case of phase-in substances, the Agency shall prepare the draft decisions in accordance with Article 40(3): ...

... (f) the name in the IUPAC Nomenclature for non-phase-in substances which are dangerous within the meaning of Directive 67/548/EEC for a period of six years; ...