INCI Regulations: Complete EU Cosmetics Guide

The EU Cosmetics Regulation 1223/2009 specifies exactly what must appear on every cosmetic product label. Getting it wrong can result in market withdrawal, fines, or legal action. This guide walks through each requirement with practical examples and actionable advice.

Whether you are launching your first product or expanding an existing range, understanding INCI regulations is non-negotiable. Every element on your cosmetic label is regulated, from the ingredient list order to the symbols you use.

What Is INCI?

INCI stands for International Nomenclature of Cosmetic Ingredients. It is a standardised naming system for cosmetic ingredients developed by the Personal Care Products Council (formerly CTFA) and adopted globally.

The purpose of INCI is to provide a uniform language for labelling cosmetic ingredients across all markets. An ingredient listed as "Aqua" on a product sold in Germany is the same ingredient listed as "Aqua" on a product sold in France, Italy, or any other EU member state.

INCI names are based on Latin botanical names for plant-derived ingredients and English names for synthetic or chemical ingredients. Water is always listed as "Aqua" in the EU (or "Water/Aqua" if dual-naming is used). Fragrance components are listed as "Parfum" unless they are known allergens requiring individual disclosure.

The official reference for INCI names in the EU is the CosIng database maintained by the European Commission. Brands must use the exact INCI name listed in CosIng — not common names, marketing names, or abbreviations.

EU Label Requirements

Article 19 of Regulation 1223/2009 specifies the mandatory information that must appear on every cosmetic product container and packaging. The following elements are required without exception.

Product Name and Function: The product must be identified by name, and its function must be clear to the consumer unless it is obvious from the product's presentation.

Net Quantity: The nominal content at the time of packaging, expressed in weight (grams) or volume (millilitres). Metric units are mandatory; imperial equivalents are optional.

Date of Minimum Durability or PAO: Products with a shelf life of 30 months or less must display a "best before" date. Products with a shelf life exceeding 30 months must display the PAO (Period After Opening) symbol.

Particular Precautions: Any warnings or conditions of use required by the Annexes to the Regulation must appear on the label.

Batch Number: A unique identifier allowing traceability back to production records. This is required by EU GMP standards (ISO 22716).

Country of Origin: Required for products manufactured outside the EU. Products manufactured at MySwissLab include "Made in Switzerland" — a valuable trust signal for premium positioning.

INCI Ingredient List Rules

The INCI ingredient list is the most technically demanding element of cosmetic labelling. Errors in ordering, naming, or allergen disclosure are among the most common reasons for regulatory non-compliance.

Ingredients must be listed in descending order of weight at the time they are added to the formula. This means the ingredient present in the highest concentration appears first, followed by the next highest, and so on.

Ingredients present at a concentration of 1% or less may be listed in any order after all ingredients above 1%. This flexibility allows brands to highlight certain ingredients without disclosing their exact concentrations.

Colourants may be listed in any order after the other ingredients, using the CI (Colour Index) number. For products sold in multiple shades, colourants may be listed with the "+/-" notation (e.g., "[+/- CI 77491, CI 77492]").

The ingredient list must be preceded by the word "Ingredients" — this is the only word that may not be translated and must appear in English on all EU labels regardless of the market language.

Responsible Person on Labels

Every cosmetic product sold in the EU must display the name and address of the Responsible Person on its label. This requirement is set out in Article 4 of Regulation 1223/2009.

The Responsible Person must be a legal entity established within the EU or EEA. They are legally responsible for the safety and compliance of the product. Their obligations include maintaining the Product Information File, ensuring GMP compliance, notifying the CPNP, and reporting serious undesirable effects.

For brands based outside the EU, appointing a Responsible Person is a mandatory step before any product can be placed on the market. MySwissLab (SBR Group Sarl) can serve as your Responsible Person — this service is included in all manufacturing agreements.

The label must display the Responsible Person's legal name and registered address. A trade name alone is not sufficient — the full legal entity name is required.

PAO Symbol and Dates

The Period After Opening (PAO) symbol is the open jar icon followed by a number and the letter "M" (e.g., "12M"). It indicates how many months the product remains safe and effective after first opening.

PAO is required for all cosmetic products with a shelf life exceeding 30 months. For products with a shelf life of 30 months or less, a "best before" date must be displayed instead, using the format "BB MM/YYYY" or the egg timer symbol followed by the date.

Determining the correct PAO value requires stability testing. Accelerated stability studies, real-time stability studies, and in-use (open pot) testing all contribute to establishing a scientifically justified PAO. Simply choosing a number without testing data is not acceptable.

Common PAO values in cosmetics range from 3M (three months) for sensitive formulations to 12M or 24M for more stable products. The PAO should reflect the actual stability data, not an aspirational shelf life.

Fragrance Allergen Disclosure

Since March 2023, EU Regulation 2022/1181 requires 56 fragrance allergens to be declared individually on labels when present above specified thresholds. Previously, brands could list them collectively as "Parfum" or "Aroma."

The threshold for declaration is 0.001% (10 ppm) for leave-on products and 0.01% (100 ppm) for rinse-off products. Any fragrance allergen present above these concentrations must be listed by its individual INCI name in the ingredient list.

This change expanded the list from the original 26 allergens to 56, and it affects virtually every fragrance-containing cosmetic formulation. Brands must obtain detailed allergen breakdowns from their fragrance suppliers to ensure accurate labelling.

Common fragrance allergens that now require declaration include Linalool, Limonene, Citronellol, Geraniol, and Hexyl Cinnamal. These are present in most essential oils and fragrance compounds.

Brands reformulating to avoid allergen declarations should be aware that "fragrance-free" products may still contain fragrance allergens in other ingredients (such as plant extracts) and must still declare them if above threshold concentrations.

Common Labelling Mistakes

Based on our experience reviewing hundreds of cosmetic labels, these are the most frequent compliance errors we encounter.

Incorrect ingredient ordering: Listing ingredients alphabetically or by marketing importance rather than by descending concentration. The INCI list must reflect actual formula composition.

Using common names instead of INCI names: Listing "Vitamin E" instead of "Tocopherol" or "Shea Butter" instead of "Butyrospermum Parkii Butter." Only official INCI names from the CosIng database are acceptable.

Missing fragrance allergens: Failing to individually declare fragrance allergens above threshold concentrations. This is increasingly common since the expanded 56-allergen list came into force.

Incomplete Responsible Person details: Using a trade name without the legal entity name, or providing an incomplete address. The full legal name and registered address are required.

Missing or incorrect PAO: Displaying a PAO without supporting stability data, or using a "best before" date when a PAO is required (and vice versa).