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Note for Guidance for Food Contact Materials
Page 28 of 126
Data requested
Guidance for providing the data requested
1. IDENTITY
OF
SUBSTANCE
1.1
individual substance:
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.
1.1.1 chemical
name:
Give chemical name of substance.
1.1.2
synonym(s):
Set out synonyms, if any.
1.1.3 trade
name(s):
Set out trade name(s), if any.
1.1.4 CAS
Nr:
Set out CAS number, if any.
1.1.5 molecular
and
structural formula:
Give molecular and structural formula.
1.1.6 molecular
weight: Give
molecular
weight.
1.1.7 spectroscopic
data:
Give spectroscopic data which allow identification of
the substance, e.g. FTIR, UV, NMR and/or MS.
Ref:
1.1.8 manufacturing
details Set out production process, including starting
substances, production control and reproducibility of
the process
If known, indicate any alternative production process
and product that can be used, and whether such
products have the same characteristics.
Ref:
1.1.9 purity
(%):
Set out percentage purity.
Set out how the purity was established. Supporting
documentation (e.g. chromatogram) should be
provided.
The substance will be evaluated for the stated level
of purity.
Ref:
1.1.10 impurities
(%):
Set out:
-
identity and typical range of percentage of
impurities,
-
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
authorities.