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Note for Guidance for Food Contact Materials
Page 52 of 126
provided.
Ref:
6.5.4 other
information:
Give any other relevant information.
Ref:
6.6 results:
Give individual test results, including blank and
recovery data. Preferably the data should be
presented in a table, which should contain sufficient
details to follow the way the final results are
obtained.
Ref:
6.7 calculated
migration
(worst case):
Set out calculation of migration of substance
assuming total migration. In case, worst case
calculation is acceptable an analytical method for
analysis has to be provided. See also document
"Commission Explanatory Guidance for Migration
Testing"
Ref:
6.8 residual
content
versus specific
migration:
Give the relationship between residual content and
specific migration, if determined.
Ref:

7
MICROBIOLOGICAL PROPERTIES OF SUBSTANCE


This section focuses on the use of antimicrobial substances incorporated into food contact
materials. Biocidal products are defined in Directive 98/8/EC as "active substances and
preparations containing one or more active substances, put up in the form in which they are
supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or
otherwise exert a controlling effect on any harmful organism by chemical or biological
means." A harmful organism is understood to be any organism "which has an unwanted
presence or a detrimental effect for humans, their activities or the products they use or
produce, or for animals or for the environment." However Article 1, 2 excludes from the
scope of this directive products defined or within the scope of Council Directive
89/109/EEC on the approximation of the laws of the member states relating to materials
and articles intended to come into contact with foodstuffs.

The following guidelines provide information to applicants regarding documentation to be
supplied in order to permit the assessment of the public health implications, i.e. safety,
efficacy including the microbiological effects of the use of an antimicrobial substance
incorporated into food contact materials. Deviations from these guidelines are allowed
provided that an appropriate justification is given.

It is not possible to give more specific guidance as to the methods to be used, as no
validated methodology has been agreed at international level. Furthermore, different
approaches may have to be followed for different substances depending on their intended
use.

It should be noted that any effect of the biocidal active substance incorporated into the food
contact material on the microbial flora of the food is strongly dependent on the contact
time of the food contact material with the food (dose-time relation). This should be taken
into account when assessing the effect of the antimicrobial substance on the microbial
flora.