Stearyl Tartrate E483
tartaric acid derivative — Primarily synthetic.
Stearyl tartrate
CAS: 15196-53-3
Factual Regulatory Reference
This database provides factual regulatory information compiled from official government sources. It does not constitute medical, nutritional, or safety advice. Regulatory status varies by country and is subject to change. Always refer to your local regulatory authority for the most current information.
What Is Stearyl Tartrate?
Stearyl tartrate is produced from stearyl alcohol and tartaric acid, functioning as a flour treatment agent that strengthens gluten in bread dough. It improves dough strength and gas retention, resulting in better bread volume and texture. JECFA established an ADI of 0–25 mg/kg body weight. EFSA reviewed stearyl tartrate in 2016. It is approved in the EU for specific bread and bakery applications under Regulation EC 1333/2008. Its use is less widespread than other dough conditioners such as DATEM (E472e) or SSL (E481).
? Did You Know?
Regulatory opinions differ: Stearyl Tartrate is approved in USA, JAPAN, CANADA but banned in EU. This reflects different risk assessment philosophies between regions.
Regulatory Analysis
Stearyl tartrate (E483) was removed from the EU's authorized food additives list effective April 2024 under Commission Regulation (EU) 2024/850 — but the reason was not a finding of toxicological concern. Rather, EFSA's 2023 re-evaluation concluded that the available safety data were insufficient to confirm the substance's safety under current EU regulatory standards. This reflects a procedural requirement of EU food additive law: additives must be re-evaluated with contemporary safety data, and if industry fails to supply adequate data, authorization lapses. The FDA retains GRAS status for E483 under 21 CFR 184.1095, and Japan, Australia, and Canada also maintain approval. The cross-jurisdictional gap that emerged in 2024 is thus a consequence of EU data requirements rather than a scientific conclusion that the substance poses a risk — a distinction central to how the EU's positive list system functions under Regulation (EC) No 1333/2008.
Detailed Regulatory Assessment
European Union (EFSA)
Authorization removed in April 2024; no longer permitted in EU
Official EFSA LinkUnited States (FDA)
Still permitted in the USA despite EU ban
Japan (MHLW)
Still approved in Japan
Acceptable Daily Intake (ADI)
International Standard (JECFA)
mg/kg body weight per day
European Standard (EFSA)
Everyday Perspective
For a kg adult, this limit is roughly equivalent to consuming:
Natural Occurrence
This additive is not known to occur naturally in significant quantities.
Manufacturing
Produced by reacting tartaric acid (typically derived from wine-making byproducts) with stearyl alcohol under controlled conditions with esterification catalysts.