(5)

Annex XI is amended as follows: (a) section 1 (‘TESTING DOES NOT APPEAR SCIENTIFICALLY NECESSARY’) is amended as follows: (i) under the header of subsection 1.1 (‘Use of existing data’), the following text is added: ‘Any data generated as from 1 June 2008 shall not be considered as existing data and shall not be subject to the general rules for adaptation laid down in this point (1.1).’; (ii) the header of point 1.1.1 is replaced by the following: ‘1.1.1. Data on physical-chemical properties from experiments not carried out according to the test methods referred to in Article 13(3)’; (iii) in subsection 1.2. (‘Weight of evidence’), the text is replaced by the following: ‘There is sufficient weight of evidence when information from several independent sources together enable, through a reasoned justification, a conclusion on the information requirement, while the information from each single source alone is insufficient to fulfil the information requirement. The justification must have regard to the information that would otherwise be obtained from the study that shall normally be performed for this information requirement. There may also be sufficient weight of evidence from the use of newly developed test methods, not yet included in the test methods referred to in Article 13(3), leading to a reasoned justification that they provide the information that would enable a conclusion on the information requirement. Weight of evidence may lead to the conclusion that a substance has or has not a particular property. If there is sufficient weight of evidence, the information requirement is fulfilled. Consequently, further testing on vertebrate animals shall be omitted and further testing not involving vertebrate animals may be omitted. In all cases, the information provided shall be adequate for the purpose of classification, labelling and/or risk assessment, and adequate and reliable documentation shall be provided, including: — robust study summaries of the studies used as sources of information; — a justification explaining why the sources of information together provide a conclusion on the information requirement. When nanoforms are covered by the registration, the above approach shall address the nanoforms separately.’; (iv) in subsection 1.5 (‘Grouping of substances and read-across approach’), the text is replaced by the following: ‘Substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity, may be considered as a group, or category, of substances. Application of the group concept requires that physicochemical properties, human health effects and environmental effects or environmental fate may be predicted from data for reference substance(s) within the group by interpolation to other substances in the group (read-across approach). This avoids the need to test every substance for every endpoint. When nanoforms are covered by the registration, the above approach shall address the nanoforms separately. For grouping different nanoforms of the same substance, the molecular structural similarities alone may not serve as a justification. If nanoforms covered by a registration are grouped or placed in a ‘category’ with other forms, including other nanoforms, of the substance in the same registration the obligations above shall apply in the same manner. The similarities may be based on any of the following: (1) a common functional group; (2) the common precursors and/or the likelihood of common breakdown products via physical and biological processes, which result in structurally similar chemicals; (3) a constant pattern in the changing of the potency of the properties across the category. Structural similarity for UVCB substances shall be established on the basis of similarities in the structures of the constituents, together with the concentration of these constituents and variability in the concentration of these constituents. If it can be demonstrated that the identification of all individual constituents is not technically possible or impractical, the structural similarity may be demonstrated by other means, to enable a quantitative and qualitative comparison of the actual composition between substances. If the group concept is applied, substances shall be classified and labelled on this basis. In all cases, results shall fulfil all of the following conditions: — be adequate for the purpose of classification and labelling and/or risk assessment, — have adequate and reliable coverage of the key parameters addressed in the corresponding study that shall normally be performed for a particular information requirement, — cover an exposure duration comparable to or longer than the corresponding study that shall normally be performed for a particular information requirement if exposure duration is a relevant parameter. In all cases, adequate and reliable documentation of the applied method shall be provided. Such documentation shall include: — a robust study summary for each source study used in the adaptation; — an explanation why the properties of the registered substance may be predicted from other substances in the group; — supporting information to scientifically justify such explanation for prediction of properties.’; (b) section 3 (‘SUBSTANCE-TAILORED EXPOSURE-DRIVEN TESTING’) is amended as follows: (i) subsection 3.1 is replaced by the following: ‘3.1. Testing in accordance with Section 8.7 of Annex VIII and in accordance with Annex IX and Annex X may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report. Testing in accordance with Section 8.6.1 of Annex VIII may be omitted only for registrants producing less than 100 tonnes per year per manufacturer or importer, based on the exposure scenario(s) developed in the Chemical Safety Report.’ (ii) point 3.2(a)(ii) is replaced by the following: ‘(ii) a DNEL or a PNEC can be derived from results of available test data for the substance concerned taking full account of the increased uncertainty resulting from the omission of the information requirement, and that DNEL or PNEC is relevant and appropriate both to the information requirement to be omitted and for risk assessment purposes. For this purpose and without prejudice to column 2 of Sections 8.6 and 8.7 of Annexes IX and X, a DNEL derived from a 28-day repeated dose toxicity study shall not be considered appropriate to omit a 90-day repeated dose toxicity study, and a DNEL derived from a screening test for reproductive/developmental toxicity shall not be considered appropriate to omit a prenatal developmental toxicity study or an extended one-generation reproductive toxicity study.’.