Flavouring Group Evaluation 16, Revision 2 (FGE.16Rev2): Aromatic ketones from chemical group 21

Abstract

The Scientific Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (the Panel) was asked to provide scientific advice to the Commission on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the Panel was requested to evaluate seven flavouring substances in the Flavouring Group Evaluation 16, Revision 2 (FGE.16Rev2), using the Procedure as referred to in the Commission Regulation (EC) No 1565/2000. These seven flavouring substances belong to chemical group 21, Annex I of the Commission Regulation (EC) No 1565/2000.

Scientific Opinion on Flavouring Group Evaluation 69, Revision 1 (FGE.69Rev1): consideration of aromatic substituted secondary alcohols, ketones and related esters evaluated by JECFA (57th meeting), structurally related to aromatic ketones from chemical group 21 evaluated by EFSA in FGE.16Rev2

“…Overall, the FAF Panel concurs with the JECFA view that the three candidate substances [FL-no: 02.066, 07.024, 07.027] in FGE.69Rev1 can be evaluated along the A-side. This is in line with the approach followed for structurally similar substances in FGE.16Rev2 (EFSA CEF Panel, 2009).…”

“…In accordance with JECFA, the Panel agrees that the three candidate substances [FL-no: Toxicokinetic data for (4-phenyl-3-buten-2-one [FL-no: 07.024]) indicate that orally administered phenyl alkyl ketones undergo essentially complete first-pass metabolism prior to systemic distribution (Sauer et al, 1997a,b). The CEF Panel in FGE.16Rev2 (EFSA CEF Panel, 2009) concluded that aryl ketones are rapidly absorbed from the gut, metabolised in the liver and further excreted mainly in the urine within 24 h.…”

“…No subacute, subchronic/chronic toxicity and carcinogenicity studies are available on the three newly included candidate substances. When available, subacute, subchronic/chronic toxicity and carcinogenicity studies for previously evaluated flavouring substances in FGE.69 are summarised in FGE.16Rev2 (EFSA CEF Panel, 2009).…”