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Note for Guidance for Food Contact Materials
Page 55 of 126
antimicrobial
substance:
the food contact material containing the biocidal
substance(s) by organisms that are insensitive to the
biocidal substance(s).
Ref:
7.6 Efficacy:
Efficacy strongly depends on migration of the
antimicrobial substance to the surface of the
material, and therefore on the type of polymer and
on its antimicrobial substance content. On the other
hand, migration should not be so high that there is a
preservative effect on food (see section 7.8).
Consequently, efficacy testing should be performed
with polymers mentioned in 3.1, especially using
that giving the highest and that giving the lowest
migration (e.g. LDPE and PET respectively). The
concentration of the antimicrobial substance in these
test materials should not exceed that indicated in 3.4
and 5.1.2.1.

Provide data to demonstrate the efficacy under the
intended conditions of use describing the testing
methodology that demonstrates this efficacy.
When the biocide is to be used at low temperatures,
e.g. in chill rooms, refrigerators, efficacy should be
demonstrated at these temperatures.
However, when this is technically impossible, e.g. in
large scale industrial applications, provide data
obtained from experiments that simulate the
intended conditions of use.
An alternative approach may rely for instance on
comparison of predicted migration values with
MICs, taking into account intrinsic and extrinsic
conditions. The model should be properly validated.
Ref:
7.7 Efficacy
upon
repeated
use
Information should be provided to describe the
behaviour of the biocidal surface after, for example,
repeated cleaning procedures. Preferably,
demonstration of efficacy under in-use conditions
could be done using microbiological tests or by
establishing the concentration of the active
substance.
Ref:
7.8 Demonstration
of
the
lack of antimicrobial
activity against
microbes in/on the
food:
Describe the evidence for absence of any effect on
the microbiological flora in/on the food including
comparison with data obtained from use of the
same/comparable FCM not containing the biocidal
substance(s).
This should cover the worst case, which could
include:
The most sensitive micro-organism(s),
The highest release level of the biocidal substance(s)
or FCM with the highest concentration applied for,