Complete Guide to EU Cosmetic Label Requirements (Regulation 1223/2009)

selling cosmetics in the European Union means complying with Regulation (EC) No 1223/2009 — the core piece of legislation governing cosmetic products in the EU. This comprehensive guide covers every mandatory element that must appear on your product label.

Whether you're a startup launching your first product or an established brand expanding into Europe, getting these details right isn't optional. Non-compliance can mean market withdrawal, fines, and reputational damage.

Who Is Responsible for Label Compliance?

Before we dive into label elements, you need to establish who the Responsible Person is. For products placed on the EU market, the Responsible Person is the legal entity accountable for compliance. This can be:

• The manufacturer established in the EU
• An importer placing the product on the EU market
• A designated third party established in the EU

The Responsible Person's name and address must appear on the label. If your company is outside the EU, you must designate an EU-based Responsible Person. For a full breakdown of RP duties, how to appoint one, and the penalties for getting it wrong, see our guide: EU Cosmetic Responsible Person: Duties, Requirements & How to Comply.

Mandatory Label Elements Under 1223/2009

Under Article 19 of Regulation 1223/2009, the following information must appear on the label:

1. INCI Ingredients List

All cosmetic products must display an INCI (International Nomenclature of Cosmetic Ingredients) list. This uses standardized ingredient names established by the EU and international bodies.

The ingredients must be listed in descending order of weight at the time of manufacture. Key rules:

• Use INCI names (e.g., "Aqua" not "water")
• Coloring agents can be listed as "CI" numbers
• Nanomaterials must be indicated with "[nano]"
• Ingredients below 1% can be listed in any order

2. Allergen Declarations

Fragrance allergens are a critical compliance area. Under the original Regulation, 26 fragrance allergens must be declared when present above certain thresholds:

• Leave-on products: > 0.001% (10 ppm)
• Rinse-off products: > 0.01% (100 ppm)

In July 2024, the European Commission expanded this list to 82 fragrance allergens through Regulation 2023/1545. The new allergens must be declared by:

• New products: July 31, 2026
• Existing products: July 31, 2028

3. Net Content

The nominal quantity must be expressed in metric units (milliliters or grams). For products sold in the EU:

• Use "ml" or "g" (not "oz" or "fl oz")
• Pre-packaged products must meet weights-and-measures regulations

4. Country of Origin

While not explicitly required by 1223/2009, the country of origin is often required per individual member state rules. "Made in [Country]" is standard practice for non-EU manufacturers.

5. Batch Number

A batch number or other identifier must be on the label to identify the manufacturing batch. This enables traceability in case of safety issues.

6. Period After Opening (PAO)

If the product's shelf life is less than 30 months, you must display a Period After Opening symbol — an open jar with a number indicating months (e.g., "12M" = 12 months after opening).

This symbol is not required when the shelf life is clearly stated as a date (day/month/year) AND the product is used within 30 months of manufacture.

7. Product Function

The label must state the intended function of the cosmetic product (e.g., "hand cream," "shampoo," "anti-aging serum").

8. Warnings

Any necessary precautions for use must appear on the label. Common examples include:

• "Avoid contact with eyes"
• "For external use only"
• "Keep out of reach of children"

Additional warnings are mandated for specific ingredients (e.g., titanium dioxide in spray products).

Label Language Requirements

Label information must be in the official language(s) of the country where the product is sold. This means if you're selling in Germany, France, and Italy, you need at minimum German, French, and Italian on your labels — or separate labels per market.

Practical Steps to Ensure Compliance

1. Audit your ingredients: Confirm all INCI names are correct and match CosIng database entries
2. Check fragrance allergens: Test or calculate all fragrance components against both the 26 classic and 56 new allergens
3. Verify label elements: Ensure every required element is present and legible
4. Prepare for deadlines: If you haven't already, begin transitioning to the expanded allergen list

Once you've reviewed the requirements, use our step-by-step walkthrough on how to check EU cosmetic label compliance in 5 steps — a practical verification checklist before production.