Division 1.10 Identity of isomers, impurities and additives (e.g. stabilisers), together with the structural formula and the content expressed as g/kgF1

The maximum content in g/kg of inactive isomers as well as the ratio of the content of isomers/diastereo-isomers, where relevant, must be provided. In addition, the maximum content in g/kg of each further component other than additives, including by-products, and impurities, must be provided. In the case of additives the content in g/kg must be provided.

For each component, present in quantities of 1 g/kg or more, the following information, where relevant, must be provided:

• chemical name in accordance with IUPAC and CA nomenclature,

• ISO common name or proposed common name if available,

• CAS number, EC (Einecs or ELINCS) number, and CIPAC number if available,

• molecular and structural formula,

• molecular mass, and

• maximum content in g/kg.

Where the manufacturing process is such that impurities and by-products which are particularly undesirable because of their toxicological, ecotoxicological or environmental properties could be present in the active substance, the content of each such compound must be determined and reported. In such cases, the analytical methods used and the limits of determination, which must be sufficiently low, for each compound of concern, must be reported. Additionally the following information, where relevant, must be provided:

• chemical name in accordance with IUPAC and CA nomenclature,

• ISO common name or proposed common name if available,

• CAS number, EC (Einecs or ELINCS) number, and CIPAC number if available,

• molecular and structural formula,

• molecular mass, and

• maximum content in g/kg.

Where the information provided relates to a pilot plant production system, the information required must again be provided once industrial scale production methods and procedures have stabilised, if production changes result in a changed specification of purity.

Where the information provided does not fully identify a component, viz. condensates, detailed information on the composition must be provided for each such component.

The trade name of components added to the active substance, prior to manufacture of formulated product, to preserve stability and facilitate ease of handling, where they are used, must also be provided. Additionally the following information, where relevant, must be provided for such additives:

• chemical name in accordance with IUPAC and CA nomenclature,

• ISO common name or proposed common name if available,

• CAS number, EC (Einecs or ELINCS) number, and CIPAC number if available,

• molecular and structural formula,

• molecular mass, and

• maximum content in g/kg.

For added components, other than active substance and other than impurities resulting from the manufacturing process, the function of the component (additive) must be given:

• antifoaming agent,

• antifreeze,

• binder,

• stabiliser,

• buffer,

• dispersing agent,

• other (specify).