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Note for Guidance for Food Contact Materials
Page 54 of 126
7.2.2 Means
contamination on the
surface of a FCM
An antimicrobial substance may be added to a FCM
to reduce the numbers of microorganisms on its
surface and in turn to reduce the possibility of cross

In this case, all information requested below should
be provided. Intended applications
of use
Describe as far as possible the intended applications.

Information should be provided on whether it is
intended to be used for industrial food processing
applications, consumer use (including catering) or

Information should also be provided on each
application, whether it is intended for "repeated use"
or "single use"? Other information
Give any information on the intended use other than
those mentioned under and in Section 3 if it
may be useful for the risk assessment of the biocide.
7.3 Spectrum
Provide data on the spectrum of activity against
various food-associated microorganisms, including
pathogens. Any insensitive genera or species known
or identified should be included.
Level of activity:
Provide information on Minimum Inhibitory
Concentration (MICs) of the pure biocidal substance
or preferably its active component e.g. silver ions,
for the microorganisms likely to be exposed to the
substance. The concentration of the microorganisms
and the nature of the test medium in which they are
exposed to the antimicrobial substance should be

Include any dose-time-response information if
available e.g. varying doses of antimicrobial
substance for a constant time or a single
concentration of antimicrobial substance for varying
times. Describe the nature of the test medium in
which the microorganisms are exposed to the

Document the possibility of resistance arising to the
antimicrobial substance in the sensitive population
or cross-resistance to other antimicrobials
7.5 Possible
of the use of the
Describe any possible encouragement to favour
selective overgrowth of the flora on the surface of