Cosmetic Glitter Regulations: FDA vs. REACH Compliance Guide

Cosmetic glitter sold in the United States must use FDA-approved color additives under 21 CFR 73 or 74, while glitter entering the European Union must comply with REACH chemical registration and the EU Cosmetics Regulation (EC) No 1223/2009. These two frameworks are not interchangeable, and a product compliant in one market may be illegal in the other. For brands sourcing wholesale glitter across borders, understanding both sets of rules is not optional — it is a legal requirement.

David Park learned this lesson when his indie makeup brand grew from Etsy sales to a UK retail partnership. The glitter he had been using for two years was fully FDA-compliant. But when UK customs tested his shipment, they flagged two pigments not on the EU's permitted list. The entire batch was held for six weeks, his retail launch was delayed, and he paid £3,200 in testing and storage fees. The delay cost him his spot in a major department store's seasonal program.

This guide breaks down the regulatory requirements for cosmetic glitter in the US, EU, UK, Australia, and Canada. It explains what documentation you need, what testing you should budget for, and how to protect your business from compliance failures.

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United States: FDA Color Additive Regulations

The FDA regulates cosmetic color additives under the Federal Food, Drug, and Cosmetic Act. Glitter used in cosmetics is classified as a color additive if it imparts color to the human body.

Permitted vs. Restricted Pigments

FDA color additives fall into two categories:

Certified colors: These are synthetic dyes that require batch certification by the FDA before use. Examples include FD&C Blue No. 1 and D&C Red No. 27. Certified colors are rarely used in glitter itself but may appear in glitter coatings.

Uncertified colors: These include mineral pigments, botanical extracts, and synthetic pigments that do not require batch certification. Most cosmetic-grade glitter uses uncertified aluminum and polyester films coated with permitted pigments like iron oxides, titanium dioxide, and mica.

The critical rule: any pigment used in cosmetic glitter must be listed in 21 CFR 73 (synthetic organic colors) or 21 CFR 74 (colors subject to batch certification). Pigments not on these lists are adulterated and illegal for cosmetic use.

Eye and Lip-Safe Restrictions

Not all approved color additives are approved for all body areas. Some pigments are restricted from eye-area use or lip use. For example:

• D&C Red No. 36 is approved for cosmetics but not for lip products.
• Chromium oxide greens are approved for external use but not for eye-area cosmetics.

If your glitter is marketed for eye shadow or lip gloss, verify that every pigment in the formulation is approved for that specific use area. This is where many indie brands unknowingly violate FDA rules.

California Proposition 65

California's Safe Drinking Water and Toxic Enforcement Act requires businesses to provide clear warnings if their products expose consumers to chemicals known to cause cancer or reproductive harm. Several pigments used in glitter, including certain chromium and nickel compounds, are on the Prop 65 list. If you sell in California, you must either ensure your glitter contains no listed chemicals or include a Prop 65 warning label. Most overseas suppliers are unaware of Prop 65, so US-based brands must conduct their own due diligence.

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European Union: REACH and the Cosmetics Regulation

The EU has the world's strictest cosmetic safety framework. Compliance involves two overlapping regulations.

REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals)

REACH requires companies to register chemical substances manufactured or imported into the EU in quantities of one ton or more per year. For glitter suppliers, this means:

• The base materials (PET film, aluminum coating, cellulose) must be registered.
• The pigments used must be registered or exempt.
• The supplier must provide a REACH compliance statement or Safety Data Sheet (SDS) in the EU format.

If your supplier cannot produce REACH registration numbers or a compliance statement, assume their product is not legally importable into the EU.

EU Cosmetics Regulation (EC) No 1223/2009

This regulation governs the safety and labeling of all cosmetic products sold in the EU. Key requirements for cosmetic glitter:

• Safety assessment: A qualified safety assessor must evaluate the product and produce a Cosmetic Product Safety Report (CPSR).
• Responsible Person: Every cosmetic product sold in the EU must have a designated Responsible Person (RP) based in the EU who maintains the product file and ensures compliance.
• Labeling: Labels must include the ingredients list using INCI names, the RP's address, batch numbers, and usage instructions.
• Animal testing ban: Cosmetic products and ingredients cannot be tested on animals. Suppliers must provide certificates of non-animal testing.

EU Microplastic Restrictions

The EU's restriction on microplastics, adopted in phases from 2023–2027, directly impacts cosmetic glitter. As of 2026:

• Loose glitter in rinse-off cosmetics is restricted.
• Leave-on cosmetic glitter restrictions are scheduled for 2027.
• Biodegradable glitter certified under OK Compost or EN 13432 is exempt.

This is the most significant regulatory shift affecting the glitter industry in the past decade. Brands selling into the EU must either switch to biodegradable glitter or exit the affected product categories.

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United Kingdom Post-Brexit Compliance

After Brexit, the UK operates its own regulatory framework, though it remains closely aligned with EU rules.

• UK REACH: A separate registration system from EU REACH. If you previously relied on an EU-registered supplier, verify their UK REACH status.
• UK Cosmetics Regulation: Similar to the EU Cosmetics Regulation but administered by the UK's Office for Product Safety and Standards (OPSS).
• Northern Ireland Protocol: Products sold in Northern Ireland must comply with EU regulations, not UK regulations. This creates a dual-compliance requirement for UK-wide distribution.

If you sell across the UK and EU, you may need separate safety assessments, separate Responsible Persons, and separate labeling. Budget for this complexity when planning European expansion.

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Australia and Canada

Both countries follow frameworks similar to the EU but with their own approved substance lists and administrative requirements.

Australia (TGA and NICNAS)

The Therapeutic Goods Administration (TGA) regulates cosmetic colorants through the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). Imported cosmetic glitter must use pigments on the Australian Inventory of Chemical Substances (AICS). If a pigment is not on the AICS, it must be notified and assessed before use — a process that takes 3–6 months and costs several thousand dollars.

Canada (Health Canada)

Health Canada's Cosmetic Regulations require that all cosmetic ingredients be listed on the Cosmetic Ingredient Hotlist. Restricted ingredients are either prohibited or limited to specific concentrations and use areas. Canada accepts FDA-approved colorants in many cases but maintains its own list of permitted and restricted substances. Labels must be bilingual (English and French).

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Documentation You Must Demand from Suppliers

Before placing any bulk cosmetic glitter order, request the following documents:

Document	What It Proves	When You Need It
MSDS / SDS	Safe handling, composition, hazards	Always; required by law for chemical shipments
Certificate of Analysis (CoA)	Batch-specific purity and safety	Every order; proves consistency
FDA Color Additive Compliance	Pigments are FDA-approved	US market entry
REACH Compliance Statement	Chemicals are registered	EU market entry
CPSR (EU)	Product safety assessed	EU/UK cosmetic sales
OK Compost / EN 13432	Biodegradability certified	EU microplastic exemption
Animal Testing Certificate	No animal testing	EU/UK cosmetic sales
Prop 65 Assessment	California compliance	California sales

Red Flags in Supplier Documentation

• Generic MSDS: A one-page document with vague language and no specific chemical names.
• Self-certified compliance: "We comply with FDA" stated on a website but no formal documentation.
• Outdated certificates: REACH registrations or CoAs dated more than 2 years old.
• Missing batch numbers: Certificates that are not tied to the specific batch you are ordering.
• Language barriers: Documents only in Chinese with no certified translation for your target market.

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Budgeting for Compliance Testing

Even with supplier documentation, independent testing is often necessary.

Test	Cost	Timeline	When Needed
Heavy metals screening	$150–$400	5–10 days	Every new supplier or batch variation
Microbial testing	$100–$250	3–7 days	Water-based or adhesive glitter products
CPSR preparation	$500–$1,500	2–4 weeks	EU/UK market entry
Third-party REACH audit	$1,000–$3,000	2–6 weeks	When supplier documentation is incomplete
Prop 65 screening	$200–$500	5–10 days	California sales, new pigments
Biodegradability verification	$800–$2,000	2–4 weeks	Biodegradable claims; EU exemption proof

Insurance Considerations

Product liability insurance for cosmetic brands typically costs $500–$2,000 annually for small businesses. Ensure your policy covers the regions where you sell and specifically includes cosmetic product liability. Some insurers require independent testing documentation before issuing a policy.

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Conclusion

Cosmetic glitter regulations are not a one-time checklist. They are an ongoing obligation that evolves with product lines, markets, and regulatory updates. The brands that treat compliance as a competitive advantage — not a burden — are the ones that scale into international retail, secure shelf space in major stores, and avoid the costly recalls and legal exposure that sink unprepared competitors.

Start by building a compliance documentation folder for every supplier and every SKU. Update it quarterly. Budget for testing when entering new markets. And never assume that a supplier's verbal assurance or website claim substitutes for written certification.