Colour plays a central role in many cosmetic products. From lipsticks and foundations to hair dyes and soaps, colour is often a key part of product identity and consumer appeal. However, in the European Union, the use of colouring agents in cosmetics is strictly regulated to ensure consumer safety and a harmonised internal market.
The Regulatory Framework
Regulation (EC) No. 1223/2009 establishes a positive-list approach: only colouring agents specifically authorised by the legislation may be used as colorants in cosmetic products placed on the EU market.
Authorised colorants are listed in Annex IV of the Regulation. Each entry may include specific conditions of use, restrictions, purity criteria, or limitations regarding the types of products in which the substance may be used. A cosmetic product containing a colorant that is not authorised under Annex IV cannot be legally marketed in the European Union for that colouring function.
This approach differs from the regulation of many other cosmetic ingredients, where substances are generally permitted unless specifically prohibited or restricted.
What Is Considered a Colorant?
According to the Regulation, a colorant is a substance primarily intended to colour a cosmetic product, the skin, hair, nails, lips, or other external parts of the human body.
The regulatory definition includes not only the colouring substance itself but also its salts where applicable. Many authorised colorants are identified by their Colour Index (CI) numbers, which provide a harmonised method of identification across the industry.
It is important to distinguish between ingredients used for their colouring function and ingredients that may incidentally impart colour while serving another primary purpose. In some cases, the regulatory classification of an ingredient depends on its intended technical function within the formulation.
Annex IV: The Positive List of Allowed Colorants
Annex IV contains the list of colouring agents authorised for cosmetic use in the European Union. The list is regularly updated to reflect scientific progress, safety assessments, and regulatory decisions.
For each authorised colorant, formulators should carefully review:
- The specific identity of the substance.
- Product categories for which use is permitted.
- Whether use near the eyes is allowed.
- Whether use on mucous membranes is permitted.
- Whether use in products intended for oral application is authorised.
- Any concentration limits or additional restrictions.
Not all authorised colorants can be used in every cosmetic product. A pigment that is acceptable in a nail polish, for example, may not be authorised for use in products applied around the eyes or lips.
As a result, compliance requires more than simply confirming that a colorant appears in Annex IV. The applicable conditions of use must also be respected.
The Importance of Safety Assessment
Even when a colorant is authorised under Annex IV, its use must still be evaluated within the context of the finished cosmetic product.
Under Regulation (EC) No. 1223/2009, every cosmetic product must undergo a safety assessment before being placed on the market. The Cosmetic Product Safety Report (CPSR) must consider all ingredients, including colorants, their concentrations, exposure routes, and potential toxicological concerns.
Authorisation in Annex IV does not automatically guarantee that any concentration or formulation is safe. The responsible person and safety assessor remain responsible for demonstrating the safety of the final product.
When selecting a colorant for a cosmetic formulation, manufacturers should verify several aspects before proceeding with product development.
The first step is confirming that the substance is authorised for use as a colorant in the EU. This verification can be performed using Annex IV and the European Commission’s CosIng database, which provides information on cosmetic ingredients and their regulatory status.
Formulators should then review all applicable restrictions, intended areas of application, purity specifications, and any updates introduced through amendments to the Cosmetics Regulation.
Finally, the chosen colorant must be incorporated into the product safety assessment and correctly declared on the product label according to the applicable labelling requirements.
Labelling Requirements for Colorants
Under EU cosmetic labelling requirements, colorants may be declared at the end of the ingredient list irrespective of their concentration, and are typically identified by their Colour Index (CI) numbers.
For decorative cosmetic products marketed in multiple shades, such as foundations, eyeshadows, or lipsticks, the Regulation also allows the use of the “may contain” approach. In these cases, colouring agents may be listed after the symbols “+” or “±”, indicating that the product may contain one or more of the listed colorants depending on the specific shade.
Correct ingredient declaration is an important aspect of compliance and helps ensure transparency for consumers and market surveillance authorities.
Regulatory Updates and Continuous Monitoring
In the European Union, cosmetic colorants are regulated through a highly structured framework based on a positive list of authorised substances. Ensuring compliance therefore involves much more than selecting an appropriate pigment or dye. Manufacturers must verify that a colorant is authorised for the intended use, comply with any applicable restrictions, incorporate it into the product safety assessment, and ensure it is correctly labelled.
A thorough understanding of Annex IV of Regulation (EC) No. 1223/2009 is therefore an essential component of formulation compliance. However, compliance should not be viewed as a one-time exercise. The regulatory landscape for cosmetic ingredients continues to evolve as new scientific evidence becomes available and regulatory authorities update existing requirements.
Scientific opinions issued by the Scientific Committee on Consumer Safety (SCCS), amendments to Regulation (EC) No. 1223/2009, and revisions to Annex IV may affect the status of authorised colorants or introduce new conditions of use. For this reason, manufacturers should regularly monitor regulatory developments and maintain effective change-management procedures. By integrating regulatory review throughout the product lifecycle, companies can minimise compliance risks and bring safe, legally compliant products to market more efficiently.
