REACH Registration & SVHC Status
Synthetic amorphous silica (SAS) used in matting agents is registered under EC 1907/2006 (REACH) with no tonnage band restrictions for coatings applications. SAS — both precipitated (CAS 112926-00-8) and fumed (CAS 112945-52-5) — does not appear on the SVHC Candidate List or Annex XIV Authorization List. Formulators exporting to the EU should confirm their supplier holds an active registration number and can provide a current Safety Data Sheet referencing the 2024 dossier update. For can coatings destined for European food-contact packaging, REACH compliance is a prerequisite before FDA or EU 10/2011 evaluation begins.
FDA Food-Contact Compliance
Precipitated silica matting agents qualify under FDA 21 CFR 175.300 (resinous and polymeric coatings) and 21 CFR 177.1460 (melamine-formaldehyde resins) for indirect food contact. Fumed silica is additionally listed under 21 CFR 172.480 as a direct food additive at ≤2% by weight. For can coatings, the critical parameter is extractable silica: compliant grades show <50 mg/kg migration in 3% acetic acid at 70 °C for 2 hours. Medical-device coatings require USP Class VI biocompatibility testing beyond FDA food-contact clearance — a separate evaluation path covered in our medical devices guide.
RoHS & Heavy Metal Limits
Matting agents produced from high-purity quartz sand via thermal or wet-process routes routinely meet EU RoHS Directive 2011/65/EU thresholds. Typical heavy metal content in coatings-grade SAS: Pb <5 ppm, Cd <1 ppm, Hg <1 ppm, Cr(VI) not detected. These values sit well below RoHS maximum concentrations (Pb 1000 ppm, Cd 100 ppm). Buyers sourcing for automotive or electronics coatings should request a recent ICP-OES test certificate showing all ten restricted substances. Suppliers with chemical resistance–certified grades often maintain tighter internal limits than RoHS requires.
ISO 9001 & Batch Consistency
ISO 9001:2015 certification at the production site ensures lot-to-lot consistency in the parameters that matter to formulators: median particle size (d50 ±0.5 µm), BET surface area (±15 m²/g), and pore volume (±0.1 mL/g). A certified quality system also mandates full traceability from raw quartz to finished micronized powder. When evaluating suppliers, request the ISO certificate number plus at least three consecutive batch COAs — consistent d50 between 3.0–5.0 µm and SiO₂ purity ≥99.0% indicate stable process control. This consistency directly impacts final coating gloss reproducibility at 5–15 GU (60°).
Compliance Spec Summary by Standard
The table below consolidates the key parameters and pass criteria across all four standards for coatings-grade matting agents.
| Standard | Scope | Key Parameter | Pass Criteria |
|---|---|---|---|
| REACH (EC 1907/2006) | EU market access | Registration dossier | Active registration, no SVHC listing |
| FDA 21 CFR 175.300 | Food-contact coatings | Extractable silica | <50 mg/kg (3% acetic acid, 70 °C / 2 h) |
| RoHS (2011/65/EU) | Electronics / automotive | Heavy metals (Pb, Cd, Hg, Cr⁶⁺) | Pb <1000 ppm, Cd <100 ppm |
| ISO 9001:2015 | Production QMS | Batch d50, BET, purity | d50 ±0.5 µm, SiO₂ ≥99.0% |
Frequently Asked Questions
Common questions about resources.
+Are all silica matting agents REACH registered?
Only synthetic amorphous silica (SAS) produced by registered EU manufacturers or importers carries valid REACH registration. Natural crystalline silica and unregistered imports do not qualify. Always verify the supplier’s registration number against the ECHA database before specifying.
+Which FDA regulation covers matting agents in can coatings?
FDA 21 CFR 175.300 covers precipitated silica in resinous coatings for food cans. The critical test is extractable silica migration below 50 mg/kg in 3% acetic acid simulant at 70 °C for 2 hours. Fumed silica has additional clearance under 21 CFR 172.480.
+Do matting agents contain restricted heavy metals?
Coatings-grade SAS typically contains Pb <5 ppm and Cd <1 ppm, far below RoHS limits of 1000 ppm and 100 ppm respectively. Request an ICP-OES test certificate from your supplier showing all ten RoHS-restricted substances with quantified detection limits.
+What batch parameters should ISO 9001 COAs include?
A useful COA reports median particle size (d50), BET surface area, pore volume, SiO₂ purity, moisture content, and pH. Consistent d50 between 3.0–5.0 µm across three consecutive lots indicates stable milling and classification process control.
+Is USP Class VI testing required for medical-device coatings?
Yes. FDA food-contact clearance alone is insufficient for medical devices. USP Class VI adds systemic toxicity, intracutaneous reactivity, and implantation testing at 50 °C, 70 °C, and 121 °C. This is a separate qualification track from food-contact compliance.
+How often should compliance certificates be renewed?
REACH registrations are ongoing but dossiers require updates when new hazard data emerges. FDA letters of compliance do not expire but should be reconfirmed when formulations change. ISO 9001 certificates renew every three years with annual surveillance audits. Request updated documents annually as standard practice.
Request a combined compliance package — REACH SDS, FDA extraction report, RoHS ICP-OES certificate, and three consecutive ISO-traceable batch COAs — before qualifying any new matting agent supplier.