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... 36. It is necessary to consider the application of Article 2(7)(a) and (b) and Annex XI to substances derived from mineralogical processes and the review of Annexes IV and V should fully take this into account. ...
... 90. In order to provide a harmonised approach to restrictions, the Agency should fulfil a role as coordinator of this procedure, for example by appointing the relevant rapporteurs and verifying conformity with the requirements of the relevant Annexes. The Agency should maintain a list of substances for which a restriction dossier is being prepared. ...
... 124. In particular, power should be conferred on the Commission to amend the Annexes in certain cases, to set rules on test methods, to vary the percentage of dossiers selected for compliance checking and to modify the criteria for their selection, and to set the criteria defining what constitutes adequate justification that testing is technically not possible. Since these measures are of general scope and are designed to amend non-essential elements of this Regulation or supplement this Regulation by adding new non-essential elements thereto, they should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. ...
ARTICLE-10: Information to be submitted for general registration purposes [go to this ARTICLE]
... (vii) robust study summaries of the information derived from the application of Annexes VII to XI, if required under Annex I; ...
ARTICLE-12: Information to be submitted depending on tonnage [go to this ARTICLE]
... (c) the information specified in Annexes VII and VIII for substances manufactured or imported in quantities of 10 tonnes or more per year per manufacturer or importer; ...
... (d) the information specified in Annexes VII and VIII and testing proposals for the provision of the information specified in Annex IX for substances manufactured or imported in quantities of 100 tonnes or more per year per manufacturer or importer; ...
... (e) the information specified in Annexes VII and VIII and testing proposals for the provision of the information specified in Annexes IX and X for substances manufactured or imported in quantities of 1 000 tonnes or more per year per manufacturer or importer. ...
... (e) the information specified in Annexes VII and VIII and testing proposals for the provision of the information specified in Annexes IX and X for substances manufactured or imported in quantities of 1 000 tonnes or more per year per manufacturer or importer. ...
ARTICLE-13: General requirements for generation of information on intrinsic properties of substances [go to this ARTICLE]
... 2. These methods shall be regularly reviewed and improved with a view to reducing testing on vertebrate animals and the number of animals involved. The Commission, following consultation with relevant stakeholders, shall, as soon as possible, make a proposal, if appropriate, to amend the Commission Regulation on test methods adopted in accordance with the procedure referred to in Article 133(4), and the Annexes of this Regulation, if relevant, so as to replace, reduce or refine animal testing. Amendments to that Commission Regulation shall be adopted in accordance with the procedure specified in paragraph 3 and amendments to the Annexes of this Regulation shall be adopted in accordance with the procedure referred to in Article 131. ...
... 2. These methods shall be regularly reviewed and improved with a view to reducing testing on vertebrate animals and the number of animals involved. The Commission, following consultation with relevant stakeholders, shall, as soon as possible, make a proposal, if appropriate, to amend the Commission Regulation on test methods adopted in accordance with the procedure referred to in Article 133(4), and the Annexes of this Regulation, if relevant, so as to replace, reduce or refine animal testing. Amendments to that Commission Regulation shall be adopted in accordance with the procedure specified in paragraph 3 and amendments to the Annexes of this Regulation shall be adopted in accordance with the procedure referred to in Article 131. ...
ARTICLE-15: Substances in plant protection and biocidal products [go to this ARTICLE]
... 2. Active substances manufactured or imported for use in biocidal products only and included either in Annexes I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market(6)or in Commission Regulation (EC) No 2032/2003 of 4 November 2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC(7), until the date of the decision referred to in the second subparagraph of Article 16(2) of Directive 98/8/EC, shall be regarded as being registered and the registration as completed for manufacture or import for the use in a biocidal product and therefore as fulfilling the requirements of Chapters 1 and 5 of this Title. ...
ARTICLE-40: Examination of testing proposals [go to this ARTICLE]
... 1. The Agency shall examine any testing proposal set out in a registration or a downstream user report for provision of the information specified in Annexes IX and X for a substance. Priority shall be given to registrations of substances which have or may have PBT, vPvB, sensitising and/or carcinogenic, mutagenic or toxic for reproduction (CMR) properties, or substances classified as dangerous according to Directive 67/548/EEC above 100 tonnes per year with uses resulting in widespread and diffuse exposure. ...
... (c) a decision in accordance with points (a), (b) or (d) but requiring registrant(s) or downstream user(s) to carry out one or more additional tests in cases of non-compliance of the testing proposal with Annexes IX, X and XI; ...
ARTICLE-41: Compliance check of registrations [go to this ARTICLE]
... (a) that the information in the technical dossier(s) submitted pursuant to Article 10 complies with the requirements of Articles 10, 12 and 13 and with Annexes III and VI to X; ...
... (b) that the adaptations of the standard information requirements and the related justifications submitted in the technical dossier(s) comply with the rules governing such adaptations set out in Annexes VII to X and with the general rules set out in Annex XI; ...
ARTICLE-43: Procedure and time periods for examination of testing proposals [go to this ARTICLE]
... (a) by 1 December 2012 for all registrations received by 1 December 2010 containing proposals for testing in order to fulfil the information requirements in Annexes IX and X; ...
ARTICLE-46: Requests for further information and check of information submitted [go to this ARTICLE]
... 1. If the competent authority considers that further information is required, including, if appropriate, information not required in Annexes VII to X, it shall prepare a draft decision, stating reasons, requiring the registrant(s) to submit the further information and setting a deadline for its submission. A draft decision shall be prepared within 12 months of the publication of the Community rolling action plan on the Agency's website for substances to be evaluated that year. The decision shall be taken in accordance with the procedure laid down in Articles 50 and 52. ...
ARTICLE-119: Electronic public access [go to this ARTICLE]
... (h) analytical methods if requested in accordance with Annexes IX or X which make it possible to detect a dangerous substance when discharged into the environment as well as to determine the direct exposure of humans. ...
ARTICLE-131: Amendments to the Annexes [go to this ARTICLE]
... Amendments to the Annexes ...
ARTICLE-138: Review [go to this ARTICLE]
... 4. The Commission shall carry out a review of Annexes I, IV and V by 1 June 2008, with a view to proposing amendments, if appropriate, to them in accordance with the procedure referred to in Article 131. ...