What is the maximum allowed concentration of thioglycolic acid derivatives in EU cosmetics?

Under EU Regulation No. 1223/2009, Annex III entry for thioglycolic acid and its salts (including calcium thioglycolate), the general maximum concentration in depilatory products is 5% (calculated as thioglycolic acid) for consumer use, and 11% for professional use with specific labeling requirements. Exact figures should be verified against the current Annex III text as regulations are periodically updated.

Does calcium thioglycolate require IECIC listing to be sold in China?

Cosmetic ingredients used in products sold in mainland China must be listed in the IECIC (Inventory of Existing Cosmetic Ingredients in China) or otherwise approved by China's National Medical Products Administration (NMPA). Calcium thioglycolate is a long-established ingredient in this category. Importers should verify current listing status directly with NMPA resources given that regulatory catalogs are updated periodically.

Ingredient Science

Calcium Thioglycolate Regulatory Status: EU, US, and China Compared

If you’re formulating or importing a product containing calcium thioglycolate, here’s where it stands under the three regulatory frameworks that matter most to global cosmetic supply chains.

Regulatory Overview CAS 814-71-1 Updated July 2026

Legal disclaimer: This page summarises publicly available regulatory information for general reference. It is not legal advice. Regulations are periodically updated — always verify current requirements against official regulatory sources or consult a qualified regulatory affairs professional before making compliance decisions.

European Union

EU Regulation No. 1223/2009

Calcium thioglycolate falls under the entry for thioglycolic acid and its salts in Annex III of EU Regulation No. 1223/2009 — the list of substances cosmetic products must comply with restrictions to contain.

EU ANNEX III — THIOGLYCOLIC ACID & SALTS (SUMMARY)

Hair removal products (general public)

Max 5% (as thioglycolic acid)

Hair removal products (professional use)

Max 11%, specific labeling required

pH requirement

Product-specific pH limits apply per entry

Labeling

Warnings on contact time, patch test recommended

Source reference: EU Regulation No. 1223/2009, Annex III. Always verify against the current consolidated text, as amendments are issued periodically. Importers into the EU market should confirm REACH registration status with their Only Representative (OR).

United States

FDA Framework & MoCRA

In the US, cosmetics are regulated under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as significantly updated by MoCRA (Modernization of Cosmetics Regulation Act of 2022). Unlike drugs, cosmetics are not pre-approved by FDA before sale — but the responsible person is accountable for safety and proper labeling.

US REGULATORY SUMMARY

Pre-market approval required?

No (cosmetics, not drugs)

Ingredient status

Listed in FDA VCRP database

Facility registration

Required for manufacturers/processors (MoCRA)

Product listing

Required, submitted via Cosmetics Direct portal

Adverse event reporting

Within 15 business days (serious events)

Safety review body

CIR (Cosmetic Ingredient Review) Expert Panel

For sellers listing on TikTok Shop specifically, see our full MoCRA compliance guide. Official source: fda.gov/cosmetics.

China

NMPA & IECIC

In mainland China, cosmetic ingredients are regulated by the National Medical Products Administration (NMPA). Ingredients must appear in the IECIC (Inventory of Existing Cosmetic Ingredients in China) or undergo new ingredient registration/notification before use in products sold domestically.

CHINA REGULATORY SUMMARY

IECIC status

Long-established listed ingredient

Regulating body

NMPA (National Medical Products Administration)

Export documentation

COA, MSDS, and safety data provided per shipment

Regulatory catalogs are periodically updated by NMPA. Importers and manufacturers should verify current listing status through official NMPA channels before finalising product registration.

Quick Reference

Three Markets, Side by Side

Aspect	EU	US	China
Ingredient banned?	No	No	No
Pre-market approval	Not required	Not required	IECIC listing required
Concentration limit	5% / 11% (professional)	No fixed % limit; must be safe as labeled	Per NMPA standards
Key regulation	Reg. 1223/2009	FD&C Act + MoCRA	NMPA / IECIC

FAQ

Common Questions

Is calcium thioglycolate banned anywhere?

No. Calcium thioglycolate is not banned in the EU, US, or China. It is a permitted cosmetic ingredient under EU Regulation No. 1223/2009 (subject to concentration limits), accepted in the US under MoCRA, and listed in China’s IECIC.

What is the maximum allowed concentration in the EU?

Under EU Regulation No. 1223/2009 Annex III, the general maximum in depilatory products is 5% (as thioglycolic acid) for consumer use, and 11% for professional use with specific labeling requirements. Verify current figures against the official Annex III text.

Does it need IECIC listing to be sold in China?

Cosmetic ingredients sold in mainland China must be IECIC-listed or otherwise NMPA-approved. Calcium thioglycolate is a long-established listed ingredient. Verify current status through official NMPA resources.