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Note for Guidance for Food Contact Materials
Page 30 of 126
1.2.11 purity
Set out percentage purity.
Set out in what way the purity was established.
Supporting documentation (e.g. chromatogram)
should be provided
The substance will be evaluated for the stated level
of purity.
1.2.12 impurities
Set out:
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
1.2.13 specifications:
Where appropriate, give a proposal for a
specification to be included in Directives.
1.2.14 other
Set out any other information that may be relevant
for evaluation.
1.3 Non-defined
Answer 'yes' or 'no'
If 'no' go to 1.4, if "yes" give information requested
in 1.3.1 to 1.3.16 as complete as possible.
Non defined mixtures are mixtures which may vary
from batch to batch, but which have a composition
within certain specifications. Typical examples of
non-defined mixtures are products derived from
natural sources. Their composition will depend on
the origin of source, climate and treatment. Also
technical processes like ethoxylation, epoxydation or
hydrogenation may create a large number of
individual components. The best available
specification of the non-defined mixture should be
submitted for authorisation.
1.3.1 chemical
Give description as complete as possible.
1.3.2 synonym(s):
Set out synonyms, if any.
1.3.3 trade
Set out trade name(s), if any.
1.3.4 CAS
Set out CAS number(s), if any.
1.3.5 starting
Set out substances or raw materials used in
manufacturing the mixture.