Talc & Major Regulatory Frameworks — REACH, RoHS, FDA

1 EU REACH (Registration, Evaluation, Authorisation & Restriction of Chemicals)

Item	Status for Talc
Substance ID	EC No. 238‑877‑9 — Hydrated magnesium silicate.
Tonnage band	≥1 t yr⁻¹ importer/manufacturer must have a registration dossier.
Current classification	Not classified as hazardous (Annex VI), provided asbestos <0.1 %.
Key dossier elements	Section 4.5 inhalation toxicity, nano-form annex; CSR required >10 t yr⁻¹.
Updates 2023‑25	ECHA draft revision adds mandatory nano‑particle size distribution data (Annex VI 2.4).
Practical impact	EU customers ask for REACH Registration Number on SDS and for confirmation “no substances of very high concern (SVHC) present”.

2 EU RoHS (Restriction of Hazardous Substances)

RoHS targets electrical & electronic equipment, not minerals per se. Talc is affected only when used as plastic filler in housings, cables, FR masterbatch.

Controlled element	Limit (homogeneous material)	Relevance to talc
Pb, Hg, Cd, Cr⁶⁺, PBB, PBDE, DEHP, BBP, DBP, DIBP	0.01–0.1 % (w/w)	Ensure trace metals in talc < ten‑ppm range; provide heavy‑metal screen on COA to OEMs.

Key point: The polymer compounder holds legal responsibility, but talc supplier provides heavy‑metal statement → keeps supply chain RoHS compliant.

3 US FDA (Food, Drug & Cosmetic Act)

a) Food‑contact (Indirect additive)

• CFR 21 § 175.300 (Resinous & polymeric coatings) and § 177.1655 (Polyolefin articles). Talc may be used as filler in accordance with good manufacturing practice.

• Heavy metals: Pb < 10 ppm, As < 3 ppm, Hg < 1 ppm (FDA Guidance 2022). Industry supplies COA + heavy‑metal panel.

b) Cosmetic talc

• No positive list, but product must be safe; FDA conducts CTFA Method J4‑1 asbestos screening. Practical market requirement: <0.01 % asbestos (TEM).

• 2024 draft rule proposes mandatory asbestos test & batch records; final rule expected 2026.

c) OTC & Pharma (excipient)

• USP‑NF Monograph “Talc”:

  • Acid‑insoluble matter ≤ 16 mg g⁻¹;

  • Microbial limits < 100 CFU g⁻¹;

  • Asbestos absent (TEM).

4 Supplier action checklist

• Maintain REACH registration dossier (update nano annex by Oct 2025).

• Provide RoHS heavy‑metal statement with every pigment‑containing grade.

• Issue FDA‑style COA (Pb, As, Hg, Cd) for any food‑contact or cosmetic shipment.

• Keep TEM asbestos certificate on file for all cosmetic/pharma talc, cross‑reference batch on invoice.

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Updated: June 2025