TY - RPRT
T1 - EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Scientific Opinion on Flavouring Group Evaluation 96 (FGE.96): Consideration of 88 flavouring substances considered by EFSA for which EU production volumes / anticipated production volumes have been submitted on request by DG SANCO. Addendum to FGE. 51, 52, 53, 54, 56, 58, 61, 62, 63, 64, 68, 69, 70, 71, 73, 76, 77, 79, 80, 83, 84, 85 and 87
AU - EFSA Publication
AU - Larsen, John Christian
AU - Nørby, Karin Kristiane
AU - Beltoft, Vibe Meister
AU - Lund, Pia
AU - Binderup, Mona-Lise
AU - Frandsen, Henrik Lauritz
PY - 2011
Y1 - 2011
N2 - The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European
Food Safety Authority was requested to consider evaluations of flavouring substances assessed since
2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide
whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000.
The present FGE.96 concerns 88 JECFA-evaluated substances from different FGEs. Common for all
the 88 substances was that for none of them European production volumes were available at the time
for the first consideration of the FGEs in question. As a consequence, no MSDI could be calculated for
EU and accordingly the substances could not be considered by EFSA using the evaluation Procedure.
Industry has now provided production volumes for these substances. Based on these newly provided
production figures, MSDI values for EU have been calculated and based on these MSDI values the
substances have been re-considered by the stepwise approach (the Procedure) that integrates
information on structure-activity relationships, intake from current uses, toxicological threshold of
concern, and available data on metabolism and toxicity. In the FGEs in question, genotoxicity of the substances considered in FGE.96 has already been addressed. For none of the substances a concern for
genotoxicity was identified. The Panel concluded that 87 of the substances do not give rise to safety
concerns at the levels of dietary intake, estimated on the basis of the MSDI approach. However, for the
substance 2-acetyl-1-ethylpyrrole [FL-no: 14.045], the Panel could not identify an appropriate
NOAEL and accordingly additional data are required. Besides the safety assessment of these
flavouring substances, the specifications for the materials of commerce have also been considered and
for eight stereoisomeric substances [FL-no: 06.040, 08.073, 09.371, 09.780, 10.050, 13.060, 13.161
and 16.039], the stereoisomeric composition has to be specified further.
AB - The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European
Food Safety Authority was requested to consider evaluations of flavouring substances assessed since
2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide
whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000.
The present FGE.96 concerns 88 JECFA-evaluated substances from different FGEs. Common for all
the 88 substances was that for none of them European production volumes were available at the time
for the first consideration of the FGEs in question. As a consequence, no MSDI could be calculated for
EU and accordingly the substances could not be considered by EFSA using the evaluation Procedure.
Industry has now provided production volumes for these substances. Based on these newly provided
production figures, MSDI values for EU have been calculated and based on these MSDI values the
substances have been re-considered by the stepwise approach (the Procedure) that integrates
information on structure-activity relationships, intake from current uses, toxicological threshold of
concern, and available data on metabolism and toxicity. In the FGEs in question, genotoxicity of the substances considered in FGE.96 has already been addressed. For none of the substances a concern for
genotoxicity was identified. The Panel concluded that 87 of the substances do not give rise to safety
concerns at the levels of dietary intake, estimated on the basis of the MSDI approach. However, for the
substance 2-acetyl-1-ethylpyrrole [FL-no: 14.045], the Panel could not identify an appropriate
NOAEL and accordingly additional data are required. Besides the safety assessment of these
flavouring substances, the specifications for the materials of commerce have also been considered and
for eight stereoisomeric substances [FL-no: 06.040, 08.073, 09.371, 09.780, 10.050, 13.060, 13.161
and 16.039], the stereoisomeric composition has to be specified further.
U2 - 10.2903/j.efsa.2011.1924
DO - 10.2903/j.efsa.2011.1924
M3 - Report
T3 - the EFSA Journal
BT - EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Scientific Opinion on Flavouring Group Evaluation 96 (FGE.96): Consideration of 88 flavouring substances considered by EFSA for which EU production volumes / anticipated production volumes have been submitted on request by DG SANCO. Addendum to FGE. 51, 52, 53, 54, 56, 58, 61, 62, 63, 64, 68, 69, 70, 71, 73, 76, 77, 79, 80, 83, 84, 85 and 87
PB - European Food Safety Authority
CY - Palma, Italy
ER -
