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Guide on the application of REACH Regulation
3.2.1 Mono constituent Substances:
One constituent is present at concentration of at least 80% (and which contains up to 20% of
impurities).
Naming
Mono-constituent substances are named after the main constituent.
Identifiers
Main constituent must be specified by all parameters. Chemical name, CAS Nos. Molecular
and Structural formula, typical concentration / concentration ranges, spectral and analytical
information.
Impurities in concentration of ≥1% should at least be specified by Chemical names, CAS Nos.
and or Molecular formula).
Analytical information
UV-Vis, IR, NMR, MS, X-Ray diffraction, X-Ray fluorescence, AAS, GC, HPLC
Impurities and additives do not contribute to the naming of the substance.
3.2.2 Multi constituent substances:
Chemical composition is known and more than one main constituent is relevant for the
identification of the substance.
Chemical composition is predictable as typical values and ranges.
A substances in which more than one constituent is present in ≥10% and <80%.
Multi constituent substance is the result of a manufacturing process. (Not blending as in case
of preparations).
Naming
Named as a reaction mass of the main constituents. (Not the starting materials needed to
produce the substance).
Names are to be mentioned in the order of typical concentration percentages starting from
the highest.
Only main constituents typically above ≥10% contribute to the name.
Impurities contributing to ≤10% shall not contribute to naming.
Identifiers
Identified by chemical names, quantitative and qualitative chemical composition,
molecular and structural formula.
Impurities present in concentration ≥1% should be specified at least by one of the following
–chemical name, CAS Nos, and or Mol formula.
Analytical information
UV-Vis, IR, NMR, MS, X-Ray diffraction, X-Ray fluorescence, AAS, GC, HPLC
3.2.3 Substance defined by more than the chemical composition:
■ Such substances in addition to chemical composition need additional identifiers
for complete identification.
■ Can be treated as mono or multi-constituent substances with additional
identifiers.
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