How to Check Cosmetic Ingredient Compliance for EU and US (Including California)

Why Ingredient Compliance Matters

If you sell cosmetic products — whether in the EU, the US, or both — you are legally required to ensure every ingredient in your formula complies with the regulations of each market. Non-compliance can result in product recalls, fines, or being banned from selling in that region entirely.

The challenge? Regulations differ significantly between the EU and the US, and they change frequently. What is allowed in one market may be restricted or prohibited in another.

EU Cosmetic Regulations

EU Cosmetics Regulation (EC) No 1223/2009

This is the primary regulation governing cosmetics in the European Union. It defines:

• Prohibited substances (Annex II) — over 1,600 ingredients that cannot be used in cosmetics
• Restricted substances (Annex III) — ingredients that can only be used under specific conditions (concentration limits, product types, warnings)
• Allowed colorants, preservatives, and UV filters (Annexes IV-VI)

EU Regulation 2024/996 (EU 82) — Allergen Updates

In 2024, the EU updated allergen labeling requirements. The new regulation expanded the list of fragrance allergens that must be declared on cosmetic product labels from 26 to 80+ substances. This means formulators must:

1. Identify all allergens present in their formulas (including those in fragrance compositions)
2. Declare them on the label if they exceed threshold concentrations
3. Update existing product labels to comply with the new requirements

CosIng Database

The EU maintains the CosIng database — the official reference for cosmetic ingredients. Each ingredient has:

• An INCI name
• Functions (emollient, surfactant, preservative, etc.)
• Any restrictions or conditions of use
• Links to the relevant annexes of the regulation

Tip: When formulating, always verify your ingredients against CosIng to confirm they are permitted and check for any restrictions.

US Cosmetic Regulations

FDA and CFR Title 21

In the United States, the FDA regulates cosmetics under the Federal Food, Drug, and Cosmetic Act. The specific rules are codified in CFR Title 21, Parts 700-740:

• Part 700 — General provisions
• Part 701 — Labeling requirements
• Part 710 — Voluntary registration of cosmetic product establishments
• Part 720 — Voluntary filing of cosmetic product ingredient composition statements
• Part 740 — Cosmetic product warning statements

Key prohibited ingredients include chloroform, vinyl chloride, halogenated salicylanilides, and certain cattle-derived materials.

MoCRA (Modernization of Cosmetics Regulation Act of 2022)

MoCRA significantly updated US cosmetic regulations for the first time in decades. Key requirements:

• Facility registration with the FDA
• Product listing including ingredient information
• Adverse event reporting within 15 business days
• Safety substantiation — companies must have evidence their products are safe
• Good Manufacturing Practices (GMP) compliance
• Labeling updates including fragrance allergen disclosure

California-Specific Regulations

California often leads the US in cosmetic safety regulations:

AB-2762: Toxic-Free Cosmetics Act

Effective January 1, 2025, this law prohibits the manufacture and sale of cosmetics containing:

• Mercury and mercury compounds
• Formaldehyde
• Certain PFAS compounds
• Dibutyl phthalate, diethylhexyl phthalate
• And several other substances

AB-496

Regulates specific chemicals in cosmetic products sold in California, adding restrictions beyond federal requirements.

AB-2771

Restricts the intentional addition of PFAS (per- and polyfluoroalkyl substances) in cosmetics sold in California, effective January 1, 2025.

How to Check Compliance: Manual vs Automated

Manual Approach

1. List all ingredients in your formula with their CAS numbers
2. Check each CAS number against:
   • EU CosIng database for EU market
   • CFR Title 21 for US market
   • California-specific laws if selling in California
3. Verify concentration limits for restricted substances
4. Check allergen thresholds for labeling requirements
5. Document everything for audit readiness

This process can take hours per formula and must be repeated whenever regulations change.

Automated Approach with Formulator Online

Formulator Online automates compliance checking directly in your formulation workflow:

1. Add ingredients to your formula — the app pulls CAS numbers and INCI names from its database
2. Run compliance check — the system automatically cross-references your ingredients against:
   • EU CosIng database
   • EU Regulation 82 allergen list
   • US FDA CFR Title 21 prohibited/restricted lists
   • California AB-2762, AB-496, and AB-2771
3. Review results — see which ingredients are prohibited, restricted, or require warning labels
4. Check incompatibilities — the app also flags ingredient pairs that should not be combined

No manual lookups, no spreadsheets, no risk of missing a regulatory update.

Best Practices for Staying Compliant

1. Always verify before launching — run a compliance check on every formula before production
2. Re-check after reformulation — even small ingredient changes can affect compliance
3. Monitor regulatory updates — regulations change; what was allowed last year may be restricted now
4. Keep documentation — maintain records of compliance checks for each product (essential for CPSR in the EU and MoCRA in the US)
5. Use standardized ingredient data — CAS numbers are the most reliable way to identify ingredients across regulatory databases

Summary

Cosmetic ingredient compliance is not optional — it is a legal requirement in every market you sell in. The EU and US have different (and sometimes conflicting) regulations, and California adds another layer of requirements.

Whether you check compliance manually or use automation tools like Formulator Online, the key is to make compliance part of your formulation workflow — not an afterthought.