Note for Guidance for Food Contact Materials
Page 109 of 126
6.4 Execution of determination:
set out execution of the determination.
6.5 Evaluation of data:
6.5.1 [TECHNIQUE] interferences:
set out 'GC' or 'HSGC' or 'HPLC', etc.
set out possible interferences and set out instructions to
solve the problems.
6.5.2 Calculation of analyte level:
set out in what manner analyte level in the matrix is
Either a mathematical or a graphical method may be applied
to calculate analyte level in the matrix.
[SM or QM] =
set out 'specific migration' or 'residual content'
set out in what way confirmation is achieved, e.g.:
For volatile substances, determined before by a GC-procedure:
i.1 Using gas chromatography/mass spectrometry (GC/MS):
If the SML or QM for the analyte and the method allow for more than
20 ng analyte/injection then full mass scanning should be carried out
for the supposed analyte peak, looking for a correspondence in the
analyte spectrum and in the spectrum of the analyte standard, in terms
of presence and correspondence of relative intensities of specified
If the analyte mass is estimated to be less than 20 ng/injection then the
selected ion monitoring (SIM) mode should be used. Confirmation is
now achieved by observance of the presence of two characteristic ions
- one of those for preference being the molecular ion - at the retention
time of the analyte, which in relative abundances agree to ± 10%.
SIM conditions could also be stated for quantitative
Set out in what way confirmation of determination is carried out.
i.2 Using at least one other column with a different polarity: