Note for Guidance for Food Contact Materials
Page 28 of 126
Guidance for providing the data requested
Answer `yes' or `no'
If `no' go to 1.2, if `yes' give information requested
in 1.1.1 to 1.1.11 as complete as possible.
Give chemical name of substance.
Set out synonyms, if any.
Set out trade name(s), if any.
Set out CAS number, if any.
Give molecular and structural formula.
Give spectroscopic data which allow identification of
the substance, e.g. FTIR, UV, NMR and/or MS.
details Set out production process, including starting
substances, production control and reproducibility of
If known, indicate any alternative production process
and product that can be used, and whether such
products have the same characteristics.
Set out percentage purity.
Set out how the purity was established. Supporting
documentation (e.g. chromatogram) should be
The substance will be evaluated for the stated level
identity and typical range of percentage of
origin of the impurities (eg starting substance,
side reaction product, degradation product)
individual impurity levels,
describe the analytical methods to determine
the impurities. Supporting documentation
(e.g. chromatograms) should be provided.
If there might be some concern about impurities,
migration and/or toxicity data on these impurities
might be requested, and specifications set by