1. Scientific Opinion on Flavouring Group Evaluation 57, Revision 1 (FGE.57Rev1): consideration of isopulegone and three flavouring substances evaluated by JECFA (55th meeting)
- Author
-
EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), ., Silano, Vittorio, Bolognesi, Claudia, Castle, Laurence, Cravedi, Jean Pierre, Engel, Karl‐Heinz, Fowler, Paul, Franz, Roland, Grob, Konrad, Gürtler, Rainer, Husøy, Trine, Kärenlampi, Sirpa, Milana, Maria Rosaria, Penninks, André, Tavares Poças, Maria de Fátima, Smith, Andrew, Tlustos, Christina, Wölfle, Detlef, Zorn, Holger, Zugravu, Corina‐Aurelia, Beckman Sundh, Ulla, Brimer, Leon, Mulder, Gerard, Marcon, Francesca, Anastassiadou, Maria, Carfí, Maria, Mennes, Wim, European Food Safety Authority = Autorité européenne de sécurité des aliments, ToxAlim (ToxAlim), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Ecole Nationale Vétérinaire de Toulouse (ENVT), Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Ecole d'Ingénieurs de Purpan (INPT - EI Purpan), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Recherche Agronomique (INRA), Institut National de la Recherche Agronomique (INRA)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Ecole Nationale Vétérinaire de Toulouse (ENVT), Université Fédérale Toulouse Midi-Pyrénées-Ecole d'Ingénieurs de Purpan (INPT - EI Purpan), and Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées
- Subjects
0301 basic medicine ,food.ingredient ,Food contact materials ,Daily intake ,Veterinary (miscellaneous) ,Group evaluation ,Isopulegone ,TP1-1185 ,Plant Science ,isopulegone ,030226 pharmacology & pharmacy ,Microbiology ,Expert committee ,Toxicology ,03 medical and health sciences ,0302 clinical medicine ,food ,isopulegol ,Medicine ,Food and Nutrition ,flavourings ,isopulegyl acetate ,pulegone ,JECFA ,FGE.57 ,TX341-641 ,Toxicity data ,Nutrition. Foods and food supply ,business.industry ,Chemical technology ,Food additive ,030104 developmental biology ,Scientific Opinion ,Alimentation et Nutrition ,Animal Science and Zoology ,Parasitology ,business ,Stepwise approach ,[SDV.AEN]Life Sciences [q-bio]/Food and Nutrition ,Food Science - Abstract
The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns a group of four flavouring substances consisting of isopulegone and three other substances evaluated by JECFA at the 55th meeting. This revision is made due to additional toxicity data available for (1R,2S,5R)‐isopulegol [FL‐no: 02.067]. The substances were evaluated through a stepwise approach that integrates information on structure–activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. p‐Mentha‐1,4(8)‐dien‐3‐one [FL‐no: 07.127] is no longer supported by the flavour industry and was not evaluated. In agreement with JECFA, the Panel evaluated the candidate substances in this Flavouring Group Evaluation (FGE) via the B‐side of the Procedure. Based on a no observed adverse effect level (NOAEL) from a 90‐day oral toxicity study on [FL‐no: 02.067], adequate margins of safety for the three candidate substances could be calculated. Therefore, the Panel agrees with the JECFA conclusion, ‘No safety concern at estimated levels of intake as flavouring substances’ based on the maximised survey‐derived daily intake (MSDI) approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered and found adequate. For the three substances evaluated in this FGE, use levels have become available and the modified theoretical added maximum daily intakes (mTAMDIs) were estimated. For [FL‐no: 02.067 and 07.067], the mTAMDI exceeds the toxicological threshold of concern for their structural classes and need more refined exposure assessment to finalise the evaluation.
- Published
- 2017