About
Shellac is a natural resin secreted by the female lac insect (Kerria lacca), refined and used as a glazing and coating agent on foods such as fresh fruits, confectionery, and coated tablets. It forms a thin, protective, shiny film that extends shelf life and improves appearance.
Safety summary
EFSA (2024) established an ADI of 4 mg/kg bw/day for wax-free shellac produced by physical decolouring; the ADI for chemically bleached shellac is considered temporary pending data on organochlorine impurities. Although the ADI was exceeded at the 95th percentile in some exposure scenarios, EFSA concluded this does not indicate a safety concern given conservative assumptions. Shellac is of animal origin (insect-derived), making it unsuitable for strict vegans and certain religious dietary requirements.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | Authorised under Regulation (EC) No 1333/2008, Annex II, at quantum satis (QS) in 11 food categories including fresh fruits, confectionery, and dietary foods. ADI of 4 mg/kg bw/day established in 2024 re-evaluation; ADI is temporary for chemically bleached shellac pending organochlorine impurity data. Wax-containing shellac has no established ADI.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Permitted as a surface coating/glazing agent for fresh fruits at GMP levels under FSS (Prohibition and Restrictions on Sales) Regulations, 2011. Also listed as bleached shellac (INS 904) as a processing aid for fruit/vegetable juices, nectars, syrups, and wine at GMP levels per FSSAI Processing Aids direction under Section 16(5).source |
| FDA (Food and Drug Administration) (United States) | Approved | Shellac (purified) is listed in FDA's database of food substances and is permitted as an indirect food additive (food contact substance) under 21 CFR 175.300. Broadly used as a confectioner's glaze (coating agent) on candies and pharmaceutical tablet coatings under GRAS/food additive provisions.source |
Who should approach with care
Research citations
- 1FDA. Shellac, purified — FDA Inventory of Food Substances (21 CFR). hfpappexternal.fda.gov
- 2EFSA. Re-evaluation of shellac (E 904) as a food additive and a new application on the extension of use of shellac (E 904) in dietary foods for special medical purposes, 2024. efsa.europa.eu
- 3PubMed. Re-evaluation of shellac (E 904) as a food additive and a new application on the extension of use of shellac (E 904) in dietary foods for special medical purposes, 2024. pubmed.ncbi.nlm.nih.gov
- 4FSSAI. Active list of processing aids allowed for use by Food Business Operators (Direction under Section 16(5)), 2024. fssai.gov.in
- 5FSSAI. Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011 — Compendium (amended 2021), 2021. fssai.gov.in
