📋 Regulatory & Compliance
Butyric Acid Regulatory Status: REACH, TSCA, FCC and Food Grade
One molecule, many rulebooks. Here is how butyric acid (CAS 107-92-6) is regulated across the EU, US and food frameworks - and what paperwork each use demands.
Butyric acid (butanoic acid, CAS 107-92-6) is used in animal feed, food flavors, coatings and pharmaceuticals - and each of those worlds has its own compliance expectations. 📋 A coating maker and a flavor house buy the same molecule, but they answer to different rules and need different documents. Getting this wrong is a real commercial risk: accept technical-grade material for a food application and you can fail an audit or a customs check.
This guide maps butyric acid's regulatory status across the major frameworks and what each grade must satisfy. It covers compliance - for the physical hazards and safe handling, see Butyric Acid Safety, Handling and Storage, and for choosing a grade, How to Choose a Butyric Acid Grade.
⚠️ Important: Regulations change and vary by jurisdiction and application. This article is general information, not legal or regulatory advice. Always confirm current requirements with the relevant authority and your own compliance team before importing, formulating or selling.
🇪🇺 REACH (European Union)
In the EU, chemicals are governed by REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals). Butyric acid is a registered substance under REACH, meaning it can be manufactured and imported into the EU within the terms of its registration. Its harmonized hazard classification (corrosive - see the safety guide) and identity are documented in the ECHA database. Importers and downstream users should ensure their supplier's REACH status covers the intended tonnage and use. Verify current entries directly at ECHA, with legal texts at EUR-Lex. ✅
🇺🇸 TSCA (United States)
In the US, industrial chemicals fall under the Toxic Substances Control Act (TSCA), administered by the EPA. Butyric acid is listed on the TSCA inventory, so it is an existing chemical permitted for commercial use in the US subject to TSCA requirements. For food and flavor uses, separate FDA frameworks apply (below). Chemical and regulatory identifiers can be checked at the US EPA CompTox Dashboard. 🏛️
🍽️ Food & Flavor: FCC, FEMA and FDA
When butyric acid is used in food flavors or food-contact applications, food-specific frameworks apply:
Check food-additive status via the US FDA and specification standards via USP / FCC. The flavor-ester applications themselves are covered in Butyric Acid Esters in Flavors & Fragrances.
🐔 Feed-Grade Considerations
For animal nutrition, butyric acid and its salts must comply with feed-additive regulations in the destination market (for example, EU feed-additive rules or the relevant national frameworks elsewhere). Requirements typically address permitted use, contaminant limits and documentation. Match feed-grade material and paperwork to your market - the gut-health context is covered in Butyric Acid in Animal Feed. 🌾
💊 Pharmaceutical-Grade Notes
Where butyric acid is used as a pharmaceutical intermediate, the relevant quality systems and pharmacopeial expectations apply, with full traceability and documentation. This is the strictest tier - see Butyric Acid as a Pharmaceutical Intermediate. 🔬
📎 Compliance Documentation Checklist
✅ SDS - current, in the correct language/format for your market
✅ CoA - assay and impurity results against the grade specification
✅ REACH status (EU) covering your tonnage and use
✅ Food/feed conformance - FCC/FEMA statement or feed-additive documentation as applicable
✅ Transport documents - correct dangerous-goods classification (UN 2820, Class 8)
📊 Framework Quick Reference
| Framework | Region / Scope | Status for butyric acid |
|---|---|---|
| REACH | EU - industrial chemicals | Registered |
| TSCA | US - industrial chemicals | Listed on inventory |
| FEMA / FCC | Food flavoring | FEMA 2221; FCC-specified |
| Feed-additive rules | Animal nutrition | Market-specific |
💡 Status shown is a general orientation; always verify the current, jurisdiction-specific position for your exact use.
💬 Frequently Asked Questions
🔹 Is butyric acid REACH registered?
Yes, butyric acid is a registered substance under EU REACH. Importers and downstream users should confirm that their supplier's registration covers the intended tonnage band and use. Check current entries at the ECHA database.
🔹 Is butyric acid on the TSCA inventory?
Yes. Butyric acid is listed on the US TSCA inventory as an existing chemical, permitted for commercial use subject to TSCA requirements. Food and flavor uses are additionally governed by FDA frameworks.
🔹 What is FEMA 2221?
FEMA 2221 is the number assigned to butyric acid by the Flavor and Extract Manufacturers Association, indicating recognition as a flavoring substance for food use under defined conditions - an important signal for food-flavor applications.
🔹 Do I need food-grade butyric acid for flavors?
Yes. Anything entering the food chain should use food-grade material meeting FCC specifications, with butyric acid recognized under FEMA 2221. Technical grade is not appropriate for food, feed or pharmaceutical uses.
🔹 What documents should I request to stay compliant?
At minimum: a current SDS, a Certificate of Analysis against the grade spec, REACH status for the EU, food/feed conformance statements where relevant, and correct dangerous-goods transport documents (UN 2820, Class 8).
📚 Related Reading
⚠️ Safety
Butyric Acid Safety, Handling and Storage →The physical hazards and GHS classification behind the regulatory picture.
🛒 Buyer's Guide
How to Choose a Butyric Acid Grade →Match grade and documentation to the framework your application answers to.
🍍 Application
Butyric Acid Esters in Flavors & Fragrances →Where FEMA 2221 and FCC status matter most - food-flavor ester applications.
Need Butyric Acid With Full Compliance Documentation? 📩
We supply butyric acid (CAS 107-92-6) with the SDS, Certificate of Analysis and grade-specific conformance your market requires - food, feed, technical or pharma. Tell us your application and destination and our team will prepare the right paperwork. Sinolook Chemical, backed by the Sinolook group, serves customers in 50+ countries.
