Note for Guidance for Food Contact Materials
Page 32 of 126
polymer used as
Answer 'yes' or 'no'
If 'no' go to 2, if "yes" give information requested in
1.4.1 to 1.4.19 as complete as possible.
Polymeric additive means any polymer and/or
prepolymer and/or oligomer, which may be added
in plastics in order to achieve a technical effect but
which cannot be used as such for the manufacture
of finished materials and articles. It includes also
polymeric substances which may be added to the
medium in which polymerisation occurs.
Give chemical name of substance, if any.
Set out synonyms, if any.
Set out trade name(s), if any.
Set out CAS number, if any.
Set out monomers and/or other starting substances.
details Set out production process, 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.
Set out additives used, if any.
Give structure of polymer.
Give weight averaged molecular mass.
1.4.10 number averaged
Give number averaged molecular mass.
Give molecular mass range, distribution curve
Curve of the distribution of the molecular masses
(see figure below). This should be obtained by GPC
or by another agreed method.
The GPC calibration supplied should include
as standards samples of the same polymer, having
their molecular mass accurately determined by an
adequate technique (their molecular mass should lie
around 1000 D). Determine the weight averaged