Cosmetic Pigment Compliance: Navigating FDA CFR Title 21 and REACH (EU)
A regulatory guide for cosmetic manufacturers on navigating FDA CFR Title 21 and EU REACH requirements for cosmetic glitters and mica powders.
The Regulatory Landscape for Cosmetic Glitters
Deploying cosmetic glitter globally requires strict adherence to two primary regulatory frameworks: the US FDA CFR Title 21 (Parts 70-82) and the EU Cosmetics Regulation (EC) No 1223/2009 coupled with REACH.
FDA CFR Title 21 Parts 70-82
In the United States, color additives are heavily regulated. Traditional PET glitter cut from metallized film is technically unapproved as a color additive for use near the eye area. However, it is broadly tolerated if the particle size is appropriately small (typically < .008" hex) and the edges are precision-cut to prevent corneal abrasion. Mica-based pigments, conversely, are explicitly approved under 21 CFR 73.1496.
EU REACH and Heavy Metals
European regulations impose strict limits on heavy metal contaminants. Our factory guarantees < 10ppm for heavy metals (Lead, Arsenic, Mercury), validated via Inductively Coupled Plasma Mass Spectrometry (ICP-MS). Furthermore, the upcoming EU ban on synthetic polymer microplastics means brands targeting the EU must pivot strictly to our Cellulose-based Biodegradable lines by 2027.
Certification Best Practices
Always request a Certificate of Analysis (COA) for every batch. A genuine COA will list the exact lot number and the quantitative results of heavy metal and microbiological testing, not just "Pass/Fail".
Need Formulation Support?
Our engineering team is ready to assist with custom specs, safety documentation, and bulk sampling. Minimum order quantity starts at 10kg.