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. 2012 Jul 11;10(7):2836. doi: 10.2903/j.efsa.2012.2836

Scientific Opinion on Flavouring Group Evaluation 9, Revision 4 (FGE.09Rev4): Secondary alicyclic saturated and unsaturated alcohols, ketones and esters containing secondary alicyclic alcohols from chemical group 8 and 30, and an ester of a phenol derivative from chemical group 25

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)
PMCID: PMC13093079  PMID: 42016082

Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 21 flavouring substances in the Flavouring Group Evaluation 9, Revision 4, using the Procedure in Commission Regulation (EC) No 1565/2000. The present revision of FGE.09 includes the assessment of four additional flavouring substances, p‐menthan‐3‐one [FL‐no: 07.059], 2,6,6‐trimethylcyclohex‐2‐en‐1‐one [FL‐no: 07.202], l‐piperitone [FL‐no: 07.255] and menthol 1‐and 2‐propylene glycol carbonate [FL‐no: 09.843]. None of the substances were considered to have genotoxic potential. The substances were evaluated through a 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. The Panel concluded that the 20 substances [FL‐no: 02.070, 02.075, 02.135, 02.167, 06.136, 07.059, 07.202, 07.203, 07.255, 09.154, 09.355, 09.520, 09.618, 09.619, 09.621, 09.843, 09.870, 09.929, 09.935 and 09.949] do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. For the remaining candidate substance [FL‐no: 07.207], additional toxicity data are requested (further metabolism and/or toxicity studies). Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have been considered. Specifications including complete purity criteria and identity for the materials of commerce have been provided for all candidate substances.

Keywords: Flavourings, alcohols, ketones, esters, secondary alicyclic, FGE.09

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) ; Scientific Opinion on Flavouring Group Evaluation 9, Revision 4 (FGE.09Rev4): Secondary alicyclic saturated and unsaturated alcohols, ketones and esters containing secondary alicyclic alcohols from chemical group 8 and 30, and an ester of a phenol derivative from chemical group 25. EFSA Journal 2012;10(7):2836. [74 pp.]. doi: 10.2903/j.efsa.2012.2836.

Panel members: Ulla Beckman Sundh, Mona‐Lise Binderup, Leon Brimer, Laurence Castle, Karl‐Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus‐Dieter Jany, Catherine Leclercq, Jean Claude Lhuguenot, Wim Mennes, Maria Rosaria Milana, Maria de Fatima Poças, Iona Pratt, Kettil Svensson, Fidel Toldra, Detlef Wölfle

Correspondence: cef@efsa.europa.eu

Acknowledgement: The Panel wishes to thank the members of the Working Groups on Flavourings for the preparation of this Opinion: Ulla Beckman Sundh, Vibe Beltoft, Leon Brimer, Wilfried Bursch, Angelo Carere, Karl‐Heinz Engel, Henrik Frandsen, Rainer Gürtler, Frances Hill, Trine Husøy, John Christian Larsen, Pia Lund, Wim Mennes, Gerard Mulder, Karin Nørby, Gerrit Speijers, Harriet Wallin and EFSA's staff member Kim Rygaard Nielsen for the preparatory work on this scientific Opinion.

Adoption date: 5 July 2012

Published date: 11 July 2012

Question number: EFSA‐Q‐2011‐01242, EFSA‐Q‐2011‐01243, EFSA‐Q‐2011‐01244, EFSA‐Q‐2011‐01245

On request from: European Commission

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