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... 38. The generation of information by alternative means offering equivalence to prescribed tests and test methods should also be allowed, for example when this information comes from valid qualitative or quantitative structure activity models or from structurally related substances. To this end the Agency, in cooperation with Member States and interested parties, should develop appropriate guidance. It should also be possible not to submit certain information if appropriate justification can be provided. Based on experience gained through RIPs, criteria should be developed defining what constitutes such justification. ...

... 96. The structure of the Agency should be suitable for the tasks that it should fulfil. Experience with similar Community agencies provides some guidance in this respect but the structure should be adapted to meet the specific needs of this Regulation. ...

... 96. The structure of the Agency should be suitable for the tasks that it should fulfil. Experience with similar Community agencies provides some guidance in this respect but the structure should be adapted to meet the specific needs of this Regulation. ...

... 100. A Commission Regulation should specify the structure and amounts of fees, including specifying the circumstances under which a proportion of the fees will be transferred to the relevant Member State competent authority. ...

... 40) Not chemically modified substance: means a substance whose chemical structure remains unchanged, even if it has undergone a chemical process or treatment, or a physical mineralogical transformation, for instance to remove impurities; ...

... 1. Information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met. In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, through the use of alternative methods, for example, in vitro methods or qualitative or quantitative structure-activity relationship models or from information from structurally related substances (grouping or read-across). Testing in accordance with Annex VIII, section 8.6 and 8.7, Annex IX and Annex X may be omitted where justified by information on exposure and implemented risk management measures as specified in Annex XI, section 3. ...

... 3. The structure and amount of the fees referred to in paragraph 1 shall take account of the work required by this Regulation to be carried out by the Agency and the competent authority and shall be fixed at such a level as to ensure that the revenue derived from them when combined with other sources of the Agency's revenue pursuant to Article 96(1) is sufficient to cover the cost of the services delivered. The fees set for registration shall take into account the work that may be done pursuant to Title VI. In the case of Article 6(4), Article 7(1) and (5), Article 9(2), Article 11(4), Article 17(2) and Article 18(2), the structure and amount of fees shall take account of the tonnage range of the substance being registered. In all cases, a reduced fee shall be set for SMEs. In the case of Article 11(4), the structure and amount of fees shall take into account whether information has been submitted jointly or separately. In the case of a request made under Article 10(a)(xi), the structure and amount of fees shall take into account the work required by the Agency in assessing the justification. ...

... 3. The structure and amount of the fees referred to in paragraph 1 shall take account of the work required by this Regulation to be carried out by the Agency and the competent authority and shall be fixed at such a level as to ensure that the revenue derived from them when combined with other sources of the Agency's revenue pursuant to Article 96(1) is sufficient to cover the cost of the services delivered. The fees set for registration shall take into account the work that may be done pursuant to Title VI. In the case of Article 6(4), Article 7(1) and (5), Article 9(2), Article 11(4), Article 17(2) and Article 18(2), the structure and amount of fees shall take account of the tonnage range of the substance being registered. In all cases, a reduced fee shall be set for SMEs. In the case of Article 11(4), the structure and amount of fees shall take into account whether information has been submitted jointly or separately. In the case of a request made under Article 10(a)(xi), the structure and amount of fees shall take into account the work required by the Agency in assessing the justification. ...

... 3. The structure and amount of the fees referred to in paragraph 1 shall take account of the work required by this Regulation to be carried out by the Agency and the competent authority and shall be fixed at such a level as to ensure that the revenue derived from them when combined with other sources of the Agency's revenue pursuant to Article 96(1) is sufficient to cover the cost of the services delivered. The fees set for registration shall take into account the work that may be done pursuant to Title VI. In the case of Article 6(4), Article 7(1) and (5), Article 9(2), Article 11(4), Article 17(2) and Article 18(2), the structure and amount of fees shall take account of the tonnage range of the substance being registered. In all cases, a reduced fee shall be set for SMEs. In the case of Article 11(4), the structure and amount of fees shall take into account whether information has been submitted jointly or separately. In the case of a request made under Article 10(a)(xi), the structure and amount of fees shall take into account the work required by the Agency in assessing the justification. ...

... 3. The structure and amount of the fees referred to in paragraph 1 shall take account of the work required by this Regulation to be carried out by the Agency and the competent authority and shall be fixed at such a level as to ensure that the revenue derived from them when combined with other sources of the Agency's revenue pursuant to Article 96(1) is sufficient to cover the cost of the services delivered. The fees set for registration shall take into account the work that may be done pursuant to Title VI. In the case of Article 6(4), Article 7(1) and (5), Article 9(2), Article 11(4), Article 17(2) and Article 18(2), the structure and amount of fees shall take account of the tonnage range of the substance being registered. In all cases, a reduced fee shall be set for SMEs. In the case of Article 11(4), the structure and amount of fees shall take into account whether information has been submitted jointly or separately. In the case of a request made under Article 10(a)(xi), the structure and amount of fees shall take into account the work required by the Agency in assessing the justification. ...

... 3. The report, referred to in Article 117(4), on the experience acquired with the operation of this Regulation shall include a review of the requirements relating to registration of substances manufactured or imported only in quantities starting at 1 tonne but less than 10 tonnes per year per manufacturer or importer. On the basis of that review, the Commission may present legislative proposals to modify the information requirements for substances manufactured or imported in quantities of 1 tonne or more up to 10 tonnes per year per manufacturer or importer, taking into account the latest developments, for example in relation to alternative testing and (quantitative) structure-activity relationships ((Q)SARs). ...