# Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed), Division (i): The information provided, taken together with that provided for one or more preparations containing the active substance, must be sufficient to permit an evaluation to be made as to the risks for man, associated with the handling and use of plant protection products containing the active substance, and the risk for man arising from residual traces remaining in food and water. In addition, the information provided must be sufficient to:

Extent: E+W+S+N.I.

permit a decision to be made as to whether, or not, the active substance can be approved,
specify appropriate conditions or restrictions to be associated with any approval,
classify the active substance as to hazard,
establish a relevant acceptable daily intake (ADI) level for man,
establish acceptable operator exposure level(s) (AOEL),
specify the pictograms, signal words, and relevant hazard and precautionary statements for the protection of man, animals and the environment to be included in packaging (containers),
identify relevant first aid measures as well as appropriate diagnostic and therapeutic measures to be followed in the event of poisoning in man, and
permit an evaluation to be made as to the nature and extent of the risks for man, animals (species normally fed and kept or consumed by man) and of the risks for other non-target vertebrate species.

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Source: https://www.legislation.gov.uk/eur/2011/544/annex/part/A/division/5/division/1/division/i (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-5/division-1/division-i
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.