About
Flavourings are a broad, heterogeneous category of substances added to food to impart, modify, or enhance taste and/or odour. They include natural flavourings derived from plant or animal sources, nature-identical substances chemically synthesised to match naturally occurring compounds, and artificial flavourings with no known natural counterpart, all used at functional levels in processed foods.
Safety summary
The safety of individual flavouring substances is assessed case-by-case by bodies such as EFSA, JECFA, and FEMA GRAS panels, evaluating genotoxicity, toxicology, and dietary exposure; most approved substances are considered safe at typical intake levels. No single class-wide ADI applies to flavourings as a group, as each substance or substance group is evaluated individually. Some specific flavouring substances have been found to pose safety concerns and have been restricted or removed from permitted lists, while the vast majority of authorised flavourings are considered safe for the general population under conditions of use.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | Authorised flavourings are listed in Annex I of Regulation (EC) No 1334/2008, which also specifies conditions of use. EFSA's Panel on Food Additives and Flavourings (FAF) carries out pre-market risk assessments covering genotoxicity, toxicology, and dietary exposure for each substance. Some substances marked with a footnote in the Union list are under ongoing additional data assessment. Smoke flavourings are separately governed by Regulation (EC) No 2065/2003.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Governed under Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. FSSAI defines 'artificial flavouring substances' as those not identified in natural products intended for human consumption. Food business operators may use natural, nature-identical, or artificial flavours per Regulation 3.3.1. Flavourings must be declared on labels of pre-packaged foods in accordance with FSS (Labelling and Display) Regulations. FSSAI is also reviewing flavourings under its ongoing Food Additives, Flavourings, Processing Aids and Materials in Contact with Food standards revision programme.source |
| FDA (Food and Drug Administration) (United States) | Approved | Synthetic flavouring substances are regulated under 21 CFR 172.515. The CFR does not contain a complete list of permissible flavourings; natural and artificial flavouring substances evaluated and assigned GRAS status by FEMA expert panels are also recognised. JECFA evaluations are referenced alongside FEMA GRAS assessments. Industry may self-determine GRAS status based on scientific evidence, though FDA strongly encourages GRAS notice submission.source |
Who should approach with care
Research citations
- 1EFSA. Flavourings — EFSA topic page. efsa.europa.eu
- 2FDA. Food Additive Status List — Synthetic flavoring substances (21 CFR 172.515). fda.gov
- 3FDA. Understanding How the FDA Regulates Food Additives and GRAS Ingredients. fda.gov
- 4PubMed. Regulation of Added Substances in the Food Supply by the Food and Drug Administration Human Foods Program, 2024. pmc.ncbi.nlm.nih.gov
- 5EFSA. Scientific Guidance on the data required for the risk assessment of flavourings to be used in or on foods, 2022. efsa.europa.eu
- 6FSSAI. Food Safety and Standards Regulations, 2009 — Definitions including artificial flavouring substances, 2009. fssai.gov.in
