EU Cosmetics Regulation

Overview

If you sell cosmetics in the European Union, your products must comply with Regulation (EC) No 1223/2009, one of the most comprehensive cosmetics regulations in the world. Formuley's EU compliance tools check your formulas against the regulation's ingredient annexes, flag allergens, and help you prepare for CPNP notification. This feature is available on the Pro plan and above.

EU Annex Categories

The EU regulation organizes controlled substances into five annexes. When you run a compliance check with the EU as a target market, Formuley evaluates every ingredient in your formula against these categories:

• Annex II (Prohibited) -- substances that must not be present in cosmetic products under any circumstances. If an ingredient is flagged under Annex II, you must remove it from your formula.
• Annex III (Restricted) -- substances allowed only under specific conditions, such as maximum concentration limits, product type restrictions, or mandatory label warnings. Formuley displays the applicable concentration limit and any required warnings.
• Annex IV (Colorants) -- approved colorants and their permitted usage. Only colorants listed in Annex IV may be used, and some are restricted to certain product types.
• Annex V (Preservatives) -- approved preservatives and their maximum concentrations. Using a preservative not on this list, or exceeding the allowed concentration, results in a compliance failure.
• Annex VI (UV Filters) -- approved UV filter substances and their maximum concentrations.

EU 26 Allergen Detection

The EU requires that 26 specific fragrance allergens be listed individually on product labels when they exceed defined thresholds. Formuley automatically detects these allergens in your formula:

1. Navigate to a formula and run a compliance check with EU selected as a target market.
2. Formuley scans your ingredients for known allergen components.
3. Any allergens found above the threshold concentration are flagged in the results.
4. The allergen list is also available when generating INCI lists and labels. See INCI List Generation for details.

For leave-on products, the threshold is 0.001% (10 ppm). For rinse-off products, it is 0.01% (100 ppm).

Concentration Limits

Many EU-restricted ingredients have maximum concentration limits that vary by product type. When Formuley detects a restricted ingredient in your formula, it displays:

• The maximum allowed concentration for your product category.
• Your ingredient's current concentration in the formula.
• Whether you are within limits, approaching the limit, or over the limit.

If your formula contains a restricted ingredient near its maximum, Formuley raises a warning so you can adjust before the formula becomes non-compliant.

CPNP Notification

Before placing a cosmetic product on the EU market, you must notify the European Commission through the Cosmetic Products Notification Portal (CPNP). Formuley helps you prepare for CPNP notification by:

• Generating the INCI ingredient list in the correct descending-concentration order.
• Identifying and listing the EU 26 allergens present in your formula.
• Flagging any nano-materials that require special notification.
• Summarizing the product's toxicological profile based on its ingredients.

While Formuley does not submit directly to CPNP, it organizes the data you need so the notification process is straightforward.

Safety Assessment

EU regulation requires a formal Cosmetic Product Safety Report (CPSR) before a product can be sold. Formuley supports your safety assessment by providing:

• Complete ingredient declarations with INCI names and concentrations.
• Regulatory status for each ingredient across all five annexes.
• Allergen identification and concentration reporting.
• Impurity and heavy metal flagging where ingredient data is available.

Your qualified safety assessor can use these reports as a foundation for the CPSR.

Country-Specific Restrictions

Some EU member states and associated markets enforce additional restrictions beyond the base regulation. When you select additional regions such as UK (post-Brexit UK Cosmetics Regulation) or other markets, Formuley checks against country-specific rules in addition to the core EC 1223/2009 requirements. Additional region support is available on the Business plan and above.

Tips

• Run EU compliance checks alongside US checks if you sell in both markets. Requirements differ significantly.
• Pay close attention to Annex III restrictions -- many common ingredients such as salicylic acid and retinol have concentration limits.
• Always disclose the EU 26 allergens on your label. The Label Generator includes an allergen callout option.
• For US-specific regulations, see FDA MoCRA Compliance.