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... 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. ...

... 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. ...

... 52. In order to respect the legitimate property rights of those generating testing data, the owner of such data should, for a period of 12 years, be able to claim compensation from those registrants who benefit from that data. ...

... 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. ...

... 72. To support the aim of eventual replacement of substances of very high concern by suitable alternative substances or technologies, all applicants for authorisation should provide an analysis of alternatives considering their risks and the technical and economic feasibility of substitution, including information on any research and development the applicant is undertaking or intends to undertake. Furthermore, authorisations should be subject to time-limited review whose periods would be determined on a case-by-case basis and normally be subject to conditions, including monitoring. ...

... 85. In relation to Annex XVII Member States should be allowed to maintain for a transitional period more stringent restrictions, provided that these restrictions have been notified according to the Treaty. This should concern substances on their own, substances in preparations and substances in articles, the manufacturing, the placing on the market and the use of which is restricted. The Commission should compile and publish an inventory of these restrictions. This would provide an opportunity for the Commission to review the measures concerned with a view to possible harmonisation. ...

... 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. ...

... 1. Articles 5, 6, 7, 17, 18 and 21 shall not apply for a period of five years to a substance manufactured in the Community or imported for the purposes of product and process orientated research and development by a manufacturer or importer or producer of articles, by himself or in cooperation with listed customers and in a quantity which is limited to the purpose of product and process orientated research and development. ...

... The notification shall be accompanied by the fee required in accordance with Title IX. The period set out in paragraph 1 shall begin at receipt of the notification at the Agency. ...

... 4. The Agency may decide to impose conditions with the aim of ensuring that the substance or the preparation or article in which the substance is incorporated will be handled only by staff of listed customers as referred to in paragraph 2(e) in reasonably controlled conditions, in accordance with the requirements of legislation for the protection of workers and the environment, and will not be made available to the general public at any time either on its own or in a preparation or article and that remaining quantities will be re-collected for disposal after the exemption period. In such cases, the Agency may ask the notifier to provide additional necessary information. ...

... 7. The Agency may decide to extend the five-year exemption period by a further maximum of five years or, in the case of substances to be used exclusively in the development of medicinal products for human or veterinary use, or for substances that are not placed on the market, for a further maximum of ten years, upon request if the manufacturer or importer or producer of articles can demonstrate that such an extension is justified by the research and development programme. ...

... Commission Decision 2003/565/EC of 25 July 2003 extending the time period provided for in Article 8(2) of Council Directive 91/414/EEC (OJ L 192, 31.7.2003, p. 40). ...

... 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. ...

... 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). ...

... 8. The registration waiting period in accordance with Article 21(1) for the new registrant shall be extended by a period of four months, if the previous registrant so requests. ...

... 8. The registration waiting period in accordance with Article 21(1) for the new registrant shall be extended by a period of four months, if the previous registrant so requests. ...

... 2. The information referred to in paragraph 1 shall be submitted within a time period starting on 1 June 2008 and ending on 1 December 2008. ...

... 1. Each manufacturer, importer, downstream user and distributor shall assemble and keep available all the information he requires to carry out his duties under this Regulation for a period of at least 10 years after he last manufactured, imported, supplied or used the substance or preparation. That manufacturer, importer, downstream user or distributor shall submit this information or make it available without delay upon request to any competent authority of the Member State in which he is established or to the Agency, without prejudice to Titles II and VI. ...

... Procedure and time periods for examination of testing proposals ...

... 2. The Agency shall use the criteria in paragraph 1 for the purpose of compiling a draft Community rolling action plan which shall cover a period of three years and shall specify substances to be evaluated each year. Substances shall be included if there are grounds for considering (either on the basis of a dossier evaluation carried out by the Agency or on the basis of any other appropriate source, including information in the registration dossier) that a given substance constitutes a risk to human health or the environment. The Agency shall submit the first draft rolling action plan to the Member States by 1 December 2011. The Agency shall submit draft annual updates to the rolling action plan to the Member States by 28 February each year. The Agency shall adopt the final Community rolling action plan on the basis of an opinion from the Member State Committee set up under Article 76(1)(e) (hereinafter referred to as "the Member State Committee") and shall publish the plan on its website, identifying the Member State who will carry out the evaluation of the substances listed therein as determined according to Article 45. ...

... 4. If the Agency receives a proposal for amendment, it may modify the draft decision. The Agency shall refer a draft decision, together with any amendments proposed, to the Member State Committee within 15 days of the end of the 30-day period referred to in paragraph 2. ...

... (d) review periods for certain uses, if appropriate; ...

... 7. When comments are made or received, the Agency shall refer the dossier to the Member State Committee within 15 days of the end of the 60-day period referred to in paragraph 5. ...

... 8. Authorisations shall be subject to a time-limited review without prejudice to any decision on a future review period and shall normally be subject to conditions, including monitoring. The duration of the time-limited review for any authorisation shall be determined on a case-by-case basis taking into account all relevant information including the elements listed in paragraph 4(a) to (d), as appropriate. ...

... (e) the time-limited review period; ...

... 1. Authorisations granted in accordance with Article 60 shall be regarded as valid until the Commission decides to amend or withdraw the authorisation in the context of a review, provided that the holder of the authorisation submits a review report at least 18 months before the expiry of the time-limited review period. Rather than re-submitting all elements of the original application for the current authorisation, the holder of an authorisation may submit only the number of the current authorisation, subject to the second, third and fourth subparagraphs. A holder of an authorisation granted in accordance with Article 60 shall submit an update of the analysis of alternatives referred to in Article 62(4)(e), including information about any relevant research and development activities by the applicant, if appropriate, and any substitution plan submitted under Article 62(4)(f). If the update of the analysis of alternatives shows that there is a suitable alternative available taking into account the elements in Article 60(5), he shall submit a substitution plan, including a timetable for proposed actions by the applicant. If the holder cannot demonstrate that the risk is adequately controlled, he shall also submit an update of the socio-economic analysis contained in the original application. If he can now demonstrate that the risk is adequately controlled, he shall submit an update of the chemical safety report. If any other elements of the original application have changed, he shall also submit updates of these element(s). When any updated information is submitted in accordance with this paragraph, any decision to amend or withdraw the authorisation in the context of the review shall be taken in accordance with the procedure referred to in Article 64 applied mutatis mutandis. ...

... 3. In preparing its opinion, each Committee referred to in paragraph 1 shall first check that the application includes all the information specified in Article 62 that is relevant to its remit. If necessary, the Committees shall, in consultation with each other, make a joint request to the applicant for additional information to bring the application into conformity with the requirements of Article 62. The Committee for Socio-economic Analysis may, if it deems it necessary, require the applicant or request third parties to submit, within a specified time period, additional information on possible alternative substances or technologies. Each Committee shall also take into account any information submitted by third parties. ...

... 5. The Agency shall send these draft opinions to the applicant by the end of the deadline set out in paragraph 1. Within one month of receipt of the draft opinion, the applicant may provide written notice that he wishes to comment. The draft opinion shall be deemed to have been received seven days after the Agency has sent it. If the applicant does not wish to comment, the Agency shall send these opinions to the Commission, the Member States and the applicant, within 15 days of the end of the period within which the applicant may comment or within 15 days of receipt of notice from the applicant that he does not intend to comment. If the applicant wishes to comment, he shall send his written argumentation to the Agency within two months of the receipt of the draft opinion. The Committees shall consider the comments and adopt their final opinions within two months of receipt of the written argumentation, taking this argumentation into account where appropriate. Within a further 15 days the Agency shall send the opinions, with the written argumentation attached, to the Commission, the Member States and the applicant. ...

... 3. The duration of the term of office shall be four years. The term of office may be renewed once. However, for the first mandate, the Commission shall identify half of its appointees, and the Council shall identify 12 of its appointees, for whom this period shall be six years. ...

... 2. The term of the office of the Executive Director shall be five 5 years. It may be prolonged by the Management Board once for another period of up to five years. ...

... 11. The Management Board shall, without delay, notify the budgetary authority of its intention to implement any project which may have significant financial implications for the funding of its budget, in particular any projects relating to property such as the rental or purchase of buildings. It shall inform the Commission thereof. Where a branch of the budgetary authority has notified its intention to deliver an opinion, it shall forward its opinion to the Management Board within a period of six weeks from the date of notification of the project. ...

... (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; ...

... The report referred to in Article 117(1) shall, in relation to enforcement, include the results of the official inspections, the monitoring carried out, the penalties provided for and the other measures taken pursuant to Articles 125 and 126 during the previous reporting period. The common issues to be covered in the reports shall be agreed by the Forum. The Commission shall make these reports available to the Agency and the Forum. ...

... (a) authorise the provisional measure for a time period defined in the decision; or ...

... 3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. ...