Division 7 EFFECTS ON HUMAN HEALTH

For proper evaluation of the toxicity including potential for pathogenicity and infectiveness of preparations sufficient information shall be available on acute toxicity, irritation and sensitisation of the micro-organism. If possible, additional information on mode of toxic action, toxicological profile and all other known toxicological aspects of the micro-organism shall be submitted. Special attention shall be given to co-formulants.

While performing toxicology studies, all signs of infection or pathogenicity shall be noted. Toxicology studies shall include clearance studies.

In the context of the influence that impurities and other components can have on toxicological behaviour, it is essential that for each study submitted, a detailed description (specification) of the material used, be provided. Tests must be conducted using the plant protection product to be authorised. In particular, it must be clear that the micro-organism used in the preparation, and the conditions of culturing it, are the same for which information and data are submitted in the context of Part B of the Annex to Regulation (EU) No 283/2013.

A tiered testing system will be applied to the study of the plant protection product.