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Note for Guidance for Food Contact Materials
Page 56 of 126
Foodstuffs spiked with the biocidal substance(s) at
concentrations exceeding the observed or calculated
migration levels.

This consideration includes:
Comparison of the observed or calculated migration
levels with MIC values,
Information on interaction of the biocidal
substance(s) with food constituents which may lead
to the inactivation of the biocide.
7.9 Other
Set out any other information that may be relevant
for evaluation.
7.10 Information on claim
or disclaimer in
accordance with the
requirement of the
relevant Directives.
The claim should be consistent with the data
described above on efficacy and activity.
7.11 Information
authorization as
biocidal product in the
frame of Directive
Supply information if the substance is listed in
Annex I or IA of Directive 98/8/EC or if it is a
constituent of biocidal products authorised under
Article 15(2) of Directive 98/8/EC or if it is a
constituent of biocidal products allowed under the
transitional measures or subject to the 10 year work
programme provided for in Article 16 of Directive


The complete report of the toxicology studies performed should be provided. The studies
should be performed following prevailing EC methods (1) and/or OECD guidelines (2) or
other internationally agreed methods, and be in compliance with good laboratory practice
The substances tested should be the commercial substances for which authorisation is
requested. Especially the percentage of purity and the identity of impurities should be the
same as those of the substances to be used in practice.
In any case, the substances used in any toxicological experiment should be described
properly and their samples tested must be traceable.
In the absence of specifications on the identity (see section 1) of the substances tested, a
justification should be provided.

8.1 Genotoxicity
In first instance, the following three in vitro
mutagenicity assays should be performed: