Annex VII STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF ONE TONNE OR MOREX1

Column 1 of this Annex establishes the standard information required for:

1. (a)

   non-phase-in substances manufactured or imported in quantities of 1 to 10 tonnes;

2. (b)

   phase-in substances manufactured or imported in quantities of 1 to 10 tonnes and meeting the criteria in Annex III in accordance with Article 12(1)(a) and (b); and

3. (c)

   substances manufactured or imported in quantities of 10 tonnes or more.

Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided. For substances not meeting the criteria in Annex III only the physicochemical requirements as set out in section 7 of this Annex are required.

Column 2 of this Annex lists specific rules according to which the required standard information may be omitted, replaced by other information, provided at a different stage or adapted in another way. If the conditions are met under which column 2 of this Annex allows adaptations, the registrant shall clearly state this fact and the reasons for each adaptation under the appropriate headings in the registration dossier.

F1Without prejudice to the information submitted for other forms, any relevant physicochemical, toxicological and ecotoxicological information shall include characterisation of the nanoform tested and test conditions. A justification shall be provided where QSARs are used or evidence is obtained by means other than testing, as well as a description of the range of the characteristics/properties of the nanoforms to which the evidence can be applied.

In addition to these specific rules, a registrant may adapt the required standard information set out in column 1 of this Annex according to the general rules contained in Annex XI with the exception of Section 3 on substance-tailored exposure waiving. In this case as well, he shall clearly state the reasons for any decision to adapt the standard information under the appropriate headings in the registration dossier referring to the appropriate specific rule(s) in column 2 or in Annex XI ^f2 .

Before new tests are carried out to determine the properties listed in this Annex, all available in vitro data, in vivo data, historical human data, data from valid (Q)SARs and data from structurally related substances (read-across approach) shall be assessed first. In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall be avoided. Prior to testing, further guidance on testing strategies should be consulted in addition to this Annex.

When, for certain endpoints, information is not provided for other reasons than those mentioned in column 2 of this Annex or in Annex XI, this fact and the reasons shall also be clearly stated.

Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided.