Division 1.10 Identity and content of additives (such as stabilisers) and impurities
United Kingdom
The minimum and maximum content in g/kg of each additive shall be provided.
The maximum content in g/kg of each further component other than additives shall also be provided.
If the active substance is manufactured as technical concentrate (TK), the maximum content of each impurity shall be given, along with their content in the theoretical dry weight material.
Isomers that are not part of the ISO common name are considered as impurities.
Where the information provided does not fully identify a component (for example condensates), detailed information on the composition shall be provided for each such component.
Where the required information is provided for a pilot plant production system, that information shall again be provided once industrial scale production methods and procedures have stabilised. Where available, industrial scale data shall be provided before approval under Regulation (EC) No 1107/2009. Where data on industrial scale production are not available, a justification shall be provided.
For plant extracts, a different approach may be taken if adequately justified.