For those active substances, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicants. The designated rapporteur Member States submitted draft assessment reports concerning the substances to the Commission on 2 March 2001 (forchlorfenuron) and 7 February 2000 (indoxacarb).

The draft assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 23 September 2005 in the format of the Commission review reports for forchlorfenuron and indoxacarb.

The review of forchlorfenuron did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants or of the European Food Safety Authority which has taken over the role of that Committee.

The SCP furthermore replied that the general and non-specific signs of toxicity observed in the acute neurotoxicity study in rats can be used as a basis for the derivation of the ARfD.

The recommendations of the SCP were taken into account during the further review by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health, in this Directive and in the Review Report. This evaluation established the relevant endpoints (ARfD and Acceptable daily intake = ADI) on the basis of the exposure levels identified by the SCP.

It has appeared from the various examinations made that plant protection products containing the active substances concerned may be expected to satisfy, in general, the requirements laid down in Article 5(1) (a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review reports. It is therefore appropriate to include forchlorfenuron and indoxacarb in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances may be granted in accordance with the provisions of that Directive.

Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing provisional authorisations of plant protection products containing forchlorfenuron or indoxacarb to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should transform existing provisional authorisations into full authorisations, amend them or withdraw them in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

The inclusion of forchlorfenuron in Annex I to Directive 91/414/EEC is based on a dossier covering the use of this active substance on kiwi fruits. Other uses are currently not adequately supported by data from the notifier and not all of the risks from such uses have shown to be adequately addressed under the criteria required by Annex VI to that Directive. If Member States are to grant authorisations for other uses, they should therefore require the data and information necessary to prove that the uses are compatible with the criteria in Directive 91/414/EEC, in particular concerning the effect on human consumers and the environment.

It is therefore appropriate to amend Directive 91/414/EEC accordingly.

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,