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- Practical Guide -
Page 46 of 153
Ms Simoneau Catherine
European Commission - Joint Research Centre (JRC)
Institute for Health and Consumer Protection
Physical and Chemical Exposure Unit
T.P.260
I-21020 ISPRA,
Italy
Phone: 39-0332-785889
Fax: 39-0332-785707
E-mail:
catherine.simoneau@jrc.it
Nota bene n. 2: Impurities in fats and fatty acids derived from natural raw materials
It is generally recognised by the legislators that the presence of minor amounts of certain fatty acids in natural
oils e.g. fatty acids with odd numbers of carbon atoms should be dealt with as impurities of the natural oil and
therefore they form part of the specification of the individually listed major components. In this way it is not
necessary for all these "rare" acids to be included in the positive list.
4.2
Information on mixtures
This section is to help industry to plan dossiers for the evaluation of mixtures.
4.2.1 Defined mixtures
a)
Synthetic mixture: mixture made by combining defined substances.
The applicant should present a separate petition for every substance in the mixture,
independently of its concentration in the mixture.
b)
Defined process mixture: mixture obtained from a reproducible process and with a
composition, which can be determined, e.g. a mixture consisting of a limited number of
isomers.
4.2.2 Non-defined mixtures
a)
Mixture from natural sources: mixtures typically of high complexity and variability, or
of high complexity resulting from further physical or chemical treatment, such as
distillation, ethoxylation or hydrogenation. Examples: edible oils and fats, rosin esters.
The applicant is requested to provide a specification of the non-defined mixture
regarding the relevant aspects.
b)
Process mixture: mixture obtained from a reproducible process and with a composition
which cannot reasonably be determined. Example: diisononylphthalate, often showing a
widely varying composition of isomers, depending on the manufacturing process.
The applicant is requested to provide a specification of the non-defined mixture
regarding the relevant aspects.