About
A chemically synthesised flavouring substance or blend whose molecular structure is identical to compounds that occur naturally in cocoa or chocolate, used to impart or reinforce chocolate taste and aroma in foods without using cocoa-derived raw materials. It is a regulatory category rather than a single compound, and its precise chemical composition varies by manufacturer and application.
Safety summary
Individual constituent substances are assessed for safety by EFSA (EU) and via the FEMA GRAS programme (US) using a stepwise approach covering structure-activity relationships, estimated intake, toxicological threshold of concern, and available metabolism and toxicity data. No category-wide ADI exists; safety is determined compound-by-compound. At typical use levels, no significant risk to the general adult population has been established, though the category distinction between 'nature-identical' and 'artificial' has been progressively merged in EU law under Regulation (EC) No 1334/2008.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| FSANZ (Food Standards Australia New Zealand) (Australia) | Approved | Permitted under Standard 1.3.1 of the Australia New Zealand Food Standards Code. Flavouring substances (including nature-identical) are permitted in food at quantum satis; individual compounds must meet the definition of a safe and suitable food additive.source |
| EFSA (European Food Safety Authority) (European Union) | Approved | Regulation (EC) No 1334/2008 replaced the earlier nature-identical/artificial distinction with a single 'flavouring substance' category evaluated via EFSA's Flavouring Group Evaluation (FGE) programme. Constituent compounds must appear on the EU Union List (Annex I) following a positive EFSA safety opinion before use is authorised. Use is governed by quantum satis in most food categories unless a specific restriction applies.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | FSSAI permits flavouring substances (including nature-identical types) in food under the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. Permitted substances are listed in the FSSAI Compendium of Flavouring Substances, aligned broadly with JECFA/FEMA evaluations. No category-specific ADI is established.source |
| FDA (Food and Drug Administration) (United States) | Approved | Chemically synthesised nature-identical flavouring substances are regulated under 21 CFR 172.515 (Synthetic Flavouring Substances and Adjuvants). Individual compounds must appear on the FEMA GRAS list or receive FDA clearance. Use is permitted at quantum satis levels (highest concentration that does not impair organoleptic character of the food). |
Who should approach with care
Research citations
- 1other. EU Lists of Flavourings – European Commission Food Safety. food.ec.europa.eu
- 2FDA. 21 CFR 172.515 – Synthetic Flavouring Substances and Adjuvants. ecfr.gov
- 3EFSA. Scientific Opinion on Flavouring Group Evaluation 49, Revision 1 (FGE.49Rev1): xanthine alkaloids (caffeine, theobromine) from the priority list, 2020. ncbi.nlm.nih.gov
- 4Codex Alimentarius / FAO. Codex Committee on Food Additives – Classification of Flavouring Substances (ALINORM 76/12 and subsequent sessions), 2017. fao.org
- 5EFSA. EFSA's evaluation of the safety of food flavouring substances – an update, 2008. efsa.europa.eu
