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- Practical Guide -
Page 138 of 153
2.5.2
Polymers used as "basic polymers" or "polymeric additives"
The SCF divided polymers into two categories:
Cat. 1. "Basic polymers"
Cat. 2.
"Polymeric additives"
The reason for this distinction is that the polymeric additives may not necessarily have
the same degree of polymerisation as the basic polymers.
The basic polymers should be not listed "if the monomers or starting substances
required to synthesise them are included in the list".
The polymeric additives should be listed and the data requested in the "SCF
Guidelines" should be provided. The criteria for their classification may be summarised
as follows:
a)
Polymers exclusively containing components with a molecular weight exceeding
1,000 D.
-
If their monomers or starting materials are in lists 0, 1, 2, 3 and 4, they are
toxicologically acceptable and classified in list 3 without specific individual
evaluation.
-
If their monomers or starting substances are in lists 6, 7, 8, 9 or not
evaluated at all, they need an individual evaluation. Data should be supplied
according to the "SCF Guidelines"
b)
Polymers with part of the components having a molecular weight below 1,000 D.
They need an individual evaluation and data should be supplied according to the
"SCF Guidelines".
These categories are distinguished because of three main reasons.
a)
The absorption by the gastrointestinal tract is negligible when the MW exceeds
1,000 Dalton.
b)
The migration of high MW material from plastics is low.
c)
Residual monomers and other low molecular weight components can be
removed.
2.5.3
Fatty acids, their dimers and trimers
The SCF made the decisions listed below.
a)
It is no longer necessary to add the notation "food grade quality" and, therefore,
all the substances containing this specification have been suppressed.
b)
All fatty acids derived from natural sources are classified in list 3, with the
annotation "constituents of natural fats".