Note for Guidance for Food Contact Materials
Page 48 of 126
results. This requires information of e.g.
chromatographic, mass spectrometric systems, or
other means of isolation or detection.
Chromatograms, spectra, etc should be provided
with a proper legend. Information or conclusions
that should be deduced from such documents should
be accompanied by an explanatory text.
In quantitative gravimetric analysis details should be
given on the method. When using quantitative
chromatographic methods, all details of the method
should be provided that may be relevant for
evaluation of the results, e.g. actual data concerning
the calibration procedure, typical chromatograms or
spectra, calibration curves, correlation coefficients.
Give detection and/or determination limit of the
method, and set out the way the detection limit was
established for quantitative determinations. Where
relevant, visual information such as typical
chromatograms, calibration curve, blank values
should be provided.
Also in qualitative analyses an indication on the
detection limit should be provided.
Set out percentage recovery of substance as
determined in recovery experiments under time-
temperature conditions of migration test.
Recovery experiments as required in specific
migration testing may or may not be possible, as no
reference substances may be available. If there are
proper arguments, then the recovery tests are not
Set out any other information that may be relevant
Describe the migratable substance(s) that have been
characterised or identified and give there migration
levels (expressed in mg/6 dmē). The presentation of
the results of the characterised or identified
migratable substance(s) may not be a
straightforward issue. Any conclusions drawn from
the investigations will need some clear reasoning
and explanation to justify these conclusions.
DATA ON RESIDUAL CONTENT OF SUBSTANCE IN THE FOOD
Answer "actual content determined" or "actual content
not determined". The need for the determination of the