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Note for Guidance for Food Contact Materials
Page 21 of 126

The general problem arising from the use of food contact materials derives from their content of
substances capable of migrating into the contacted food. Therefore, to protect the consumer, an
assessment of the potential hazards from oral exposure to those constituents that migrate into the
food must be made.

To establish the safety from ingestion of migrating substances, both the toxicological data
indicating the potential hazard and the likely human exposure data need to be combined.
However, the Committee is aware that for most substances used in food contact materials, human
exposure data are not readily available. The Committee will therefore continue to use data from
studies on migration into food or food simulants and, for reasons of prudence, maintains the
assumption that a person may consume daily up to 1 kg of food in contact with the relevant food
contact material. The Committee is aware that studies on food consumption factors are ongoing
and these may permit eventually more accurate estimates of intake.

These guidelines replace the ones published in the 26
Series of Reports of the SCF

These revised guidelines were developed to provide guidance to the applicant on the scope of the
data requirement, the latter depending on the extent of the likely migration into food, and to
enable the SCF to evaluate any substance used in the intended application as food contact

It should be noted, however, that these guidelines should not be applied or interpreted too rigidly.
For example, since the petitioner has knowledge of the identity, use of and potential exposure to
the substance requested, and of the database available for it, the petitioner may deviate from the
guidelines, provided valid, scientific reasons are given in the application. On the other hand, the
petitioner should provide all available data, which are relevant for the evaluation by the SCF. In
all cases the SCF may request additional data, if the data submitted are equivocal or warrant
further investigation.

As a general principle, the greater the exposure through migration, the more toxicological
information will be required.

(a) In case of high migration (i.e.5 - 60 mg/kg/food), an extensive data set is needed to
establish the safety.

(b) In case of migration between 0.05 5 mg/kg food, a reduced data set may suffice.

(c) In case of low migration (i.e. <0.05 mg/kg food), only a limited data set is needed.

3 The revised guidelines were adopted by the SCF on 22 November 2000, at its 124th Plenary meeting
(Document reference SCF/CS/PLEN/GEN/90 Final). On 13 December 2001, at its 130th meeting, the
Committee updated these revised guidelines to incorporate a section referring to biocides. The update also
harmonised the presentation of the toxicological data, core set of studies, with the one in the guidelines relating
to food additives, adopted by the Committee on 11 July 2001, at its 128th Plenary (Document "Guidance on
submissions for food additive evaluations by the Scientific Committee on Food, reference SCF/CS/ADD/GEN
26 final) .