Scientific Opinion on Flavouring Group Evaluation 35, Revision 1 (FGE.35Rev1): Three quinine salts from the Priority list from chemical group 30

flavourings, food safety, quinine salts, FGE.35
First published in the EFSA Journal
30 September 2015
9 September 2015
Scientific Opinion
The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate three flavouring substances in the Flavouring Group Evaluation 35, Revision 1, using the Procedure in Commission Regulation (EC) No 1565/2000. The present revision includes new specification data on quinine sulphate [FL-no: 14.152] and quinine monohydrochloride dihydrate [FL-no: 14.155], new intake data on all three candidate substances and toxicological and genotoxicity data on quinine hydrochloride [FL-no: 14.011] and quinine monohydrochloride dihydrate [FL-no: 14.155], as well as two structurally related quinine salts (quinine dihydrochloride and deoxyquinine). A search in open literature has been made and the relevant data are presented. This evaluation concerns only the use of these quinine salts in beverages, where they are legally permitted. Because of the availability of well conducted human studies at much higher quinine exposures than those occurring when quinine is used as flavouring substance and which were considered in this FGE.35Rev1, the Panel considered the use of the Procedure for these substances inappropriate. However, based on human data available on quinine, the Panel concluded that the quinine salts are not expected to be of safety concern at their estimated level of intake as flavouring substances, provided that hypersensitivity reactions are avoided by the legally required labelling of quinine-containing beverages. The Panel noted that a very high intake (e.g. more than 1 litre) of non-alcoholic beverages containing quinine or its salts at the maximum permitted level could result in adverse health effects in humans. Besides the safety assessment of these three flavouring substances, the specifications for the materials of commerce have also been considered. Adequate specifications, including complete purity criteria and identity, have been provided for all three candidate substances.
Panel members at the time of adoption
Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Maria de Fatima Tavares Poças, Vittorio Silano, Andrew Smith, Christina Tlustos, Fidel Toldra, Detlef Wölfle and Holger Zorn.
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
fip [at]
EFSA Journal 2015;13(9):4245
On request from
European Commission