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Note for Guidance for Food Contact Materials
Page 29 of 126
1.1.11 specifications:
Where appropriate, submit a proposal for a
specification (eg level of purity, nature and
percentage of impurities, type of polymer to be used
...) to be included in the Directive.
Ref:
1.1.12 other
information:
Set out any other information that may be relevant
for evaluation.
Ref:
1.2
defined mixture:
Answer 'yes' or 'no'
If 'no' go to 1.3, if "yes" give information requested
in 1.2.1 to 1.2.13 as completely as possible.
This section only deals with "process mixtures",
obtained from a reproducible process and where the
detailed composition can be easily determined (e.g.
mixture of isomers).
"Synthetic mixtures", made up by intentionally of
individual identified components are not considered
in this section.
See also the explanation given in the Document
"Practical Guide".
1.2.1 chemical
name:
Give chemical name of mixture, if any.
1.2.2 synonym(s):
Set out synonyms, if any.
1.2.3 trade
name(s):
Set out trade name(s), if any.
1.2.4 CAS
Nr:
Set out CAS number (s), if any.
1.2.5 constituents:
Set out chemical name(s) of constituents of the
mixture.
1.2.6
proportions in the
mixture:
Set out proportions of substances in the mixture.
Ref:
1.2.7 molecular
and
structural formula:
Give molecular and structural formula of each
component including isomers.
1.2.8 molecular
weight
(Mw) and range:
Give molecular weight (weight averaged molecular
mass) and molecular mass range.
Ref:
1.2.9
spectroscopic data:
Give spectroscopic data which allow identification of
the mixture, e.g. FTIR, UV, NMR and/or MS.
Ref:
1.2.10 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: