The current data requirements for the EU dossier of an active substance are set out in Regulation (EU) 283/2013. These data facilitate an in-depth assessment of the active substance.
The data are sub-divided into various sections:
- physical and chemical properties,
- information regarding use,
- methods of analysis,
- toxicology and metabolism,
- residues in food and feed,
- fate and behaviour in the environment and
In addition, data are also required for at least one representative formulation which contains the active substance in question. The data requirements are laid down in Regulation (EU) 284/2013 and are further explained under technical requirements.
The methodologies and guidelines which must be used to generate these data are listed in the COM Communications.
Based on the data for both the active substance and the representative formulation(s), it must be demonstrated that at least one acceptable use exists (within the meaning of art. 4 of Regulation (EC) 1107/2009). This is a requirement to be able to approve the active substance.