Division 4 Annex VII to Regulation (EC) No 1907/2006 is amended as follows:

In the introductory text, the following text is added after the third paragraph:

‘Without 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.’;

Subsection 7.7 is replaced by the following:

‘

7.7. Water solubility For nanoforms, in addition the testing of dissolution rate in water as well as in relevant biological and environmental media shall be considered.

7.7. The study does not need to be conducted if: the substance is hydrolytically unstable at pH 4, 7 and 9 (half-life less than 12 hours), or the substance is readily oxidisable in water. If the substance appears “insoluble” in water, a limit test up to the detection limit of the analytical method shall be performed. For nanoforms the potential confounding effect of dispersion shall be assessed when conducting the study.

’;

Subsection 7.8 is replaced by the following:

‘

7.8. Partition coefficient n-octanol/water

7.8. The study does not need to be conducted if the substance is inorganic. If the test cannot be performed (e.g. the substance decomposes, has a high surface activity, reacts violently during the performance of the test or does not dissolve in water or in octanol, or it is not possible to obtain a sufficiently pure substance), a calculated value for log P as well as details of the calculation method shall be provided. For nanoforms the potential confounding effect of dispersion in octanol and water shall be assessed when conducting the study. For nanoforms, whether of inorganic or organic substances, for which the partition coefficient n-octanol/water is not applicable the study of dispersion stability shall be considered instead.

’;

After subsection 7.14., the following is added:

‘

7.14bis Dustiness For nanoforms

7.14bis. The study does not need to be conducted if exposure to granular form of the substance during its life-cycle can be excluded.

’;

Point 8.4.1. is replaced by the following:

‘

8.4.1. In vitro gene mutation study in bacteria

8.4.1. The study does not need to be conducted for nanoforms where it is not appropriate. In this case other studies involving one or more in vitro mutagenicity study(ies) in mammalian cells (Annex VIII, sections 8.4.2. and 8.4.3 or other internationally recognised in vitro methods) shall be provided.

’;

Point 8.5.1 is replaced by the following:

‘

8.5.1. By oral route

8.5.1. The study need not be conducted if a study on acute toxicity by the inhalation route (8.5.2) is available. For nanoforms, a study by the oral route shall be replaced by a study by the inhalation route (8.5.2), unless exposure of humans via inhalation is unlikely, taking into account the possibility of exposure to aerosols, particles or droplets of an inhalable size.

’;

Point 9.1.1. is replaced by the following:

‘

9.1.1. Short-term toxicity testing on invertebrates (preferred species Daphnia) The registrant may consider long-term toxicity testing instead of short-term.

9.1.1. The study does not need to be conducted if: there are mitigating factors indicating that aquatic toxicity is unlikely to occur for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes, a long-term aquatic toxicity study on invertebrates is available, or adequate information for environmental classification and labelling is available. For nanoforms, the study may not be waived on the basis of high insolubility in water alone. The long-term aquatic toxicity study on Daphnia (Annex IX, section 9.1.5.) shall be considered if the substance is poorly water soluble, or for nanoforms if they have low dissolution rate in the relevant test media.

’;

Point 9.1.2. is replaced by the following:

‘

9.1.2. Growth inhibition study aquatic plants (algae preferred)

9.1.2. The study does not need to be conducted if there are mitigating factors indicating that aquatic toxicity is unlikely to occur for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes. For nanoforms, the study may not be waived on the basis of high insolubility in water alone.

’;