Division 1.11 The information on the active substance, taken together with the information concerning one or more plant protection products containing the active substance and together, if appropriate, with the information concerning safeners and synergists and other components of the plant protection product, shall be sufficient to:

permit an assessment of the risks for humans, associated with handling and use of plant protection products containing the active substance;

permit an assessment of the risks for human and animal health, arising from residues of the active substance and its metabolites, impurities, breakdown and reaction products remaining in water, air, food and feed;

predict the distribution, fate and behaviour in the environment of the active substance and metabolites, breakdown and reaction products, where they are of toxicological or environmental significance, as well as the time courses involved;

permit an assessment of the impact on non-target species (flora and fauna), including the impact on their behaviour, which are likely to be exposed to the active substance, its metabolites, breakdown and reaction products, where they are of toxicological or environmental significance. Impact can result from single, prolonged or repeated exposure and can be direct or indirect, reversible or irreversible;

evaluate the impact on biodiversity and the ecosystem;

identify non-target species and populations for which hazards arise because of potential exposure;

permit an evaluation of short and long-term risks for non-target species, populations, communities and processes;

classify the active substance as to hazard in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council^f1;

specify the pictograms, the signal words, and relevant hazard and precautionary statements for the protection of man, non-target species and the environment, which are to be used for labelling purposes;

establish, where relevant, an acceptable daily intake (ADI) level for humans;

establish acceptable operator exposure levels (AOEL);

establish, where relevant, an acute reference dose, (ARfD) for humans;

identify relevant first aid measures as well as appropriate diagnostic and therapeutic measures to be followed in the event of poisoning in humans;

establish the isomeric composition and the possible metabolic conversion of the isomers, when relevant;

establish residues definitions appropriate for risk assessment;

establish residues definitions appropriate for monitoring and enforcement purposes;

permit a risk assessment of consumer exposure, including, where relevant, a cumulative risk assessment deriving from exposure to more than one active substance;

permit an estimation of the exposure to operators, workers, residents and bystanders including, where relevant, the cumulative exposure to more than one active substance;

establish maximum residue levels and concentration/dilution factors in accordance with Regulation (EC) No 396/2005 of the European Parliament and of the Council^f2;

permit an evaluation to be made as to the nature and extent of the risks for man, animals (species normally fed and kept by humans or food producing animals) and of the risks for other non-target vertebrate species;

identify measures necessary to minimise contamination of the environment and impact on non-target species;

decide whether or not the active substance has to be considered as persistent organic pollutant (POP), persistent, bio accumulative and toxic (PBT) or very persistent and very bio accumulative (vPvB) in accordance with the criteria laid down in Annex II to Regulation (EC) No 1107/2009;

decide whether or not the active substance has to be considered as a candidate for substitution in accordance with the criteria laid down in Annex II to Regulation (EC) No 1107/2009;

decide whether or not the active substance has to be considered as a low-risk active substance in accordance with the criteria laid down in Annex II to Regulation (EC) No 1107/2009;

decide whether, or not, the active substance is to be approved;

specify conditions or restrictions to be associated with any approval.