Allergen labelling on the label of cosmetic products

Obligation of allergen labelling in cosmetics derives directly from the law and applies to any manufacturer who introduces a product containing certain fragrances. Omitting this information on the label can result in serious consequences - both legally and in terms of image. In this article, we discuss how to correctly identify allergens, when they should be declared and what the list of substances requiring labelling currently covers.

Allergens in cosmetics - when must they be declared?

Allergens in cosmetics are substances that can cause allergic reactions, most commonly associated with fragrances or natural essential oils. It is sufficient that their concentration exceeds a certain threshold for the manufacturer to be obliged to list their names on the packaging.

This threshold is:

• 0,001% for non-rinsing products (e.g. creams, lotions),
• 0,01% for rinse-off products (e.g. shampoos, shower gels).
  

It does not matter whether a substance comes from a natural source or has been synthetically produced - what matters is the actual concentration in the finished product. This information must be included in the INCI formulation.

List of allergens - regulation and changes worth knowing

The current provisions on fragrance allergens are laid down in Annex III of Regulation (EC) No 1223/2009. The existing list of 26 substances has been as extended by Commission Regulation (EU) 2023/1545 and currently includes more than 80 allergenswhich will have to be compulsorily declared on the packaging of cosmetics from 31 July 2026.

Among the substances currently mandatory to be labelled are:

• Limonene,
  
• Linalool,
  
• Citral,
  
• Eugenol,
  
• Geraniol.
  

The aim of the changes is to increase consumer health protection by bringing labelling requirements in line with the latest toxicological and allergological data. Cosmetics manufacturers should keep abreast of existing and upcoming regulations - both with regard to concentration thresholds and the extended list of substances considered allergenic.

Allergen labelling - how to label correctly?

Allergen labelling must follow the rules for declaring ingredients according to the nomenclature INCI. The manufacturer is obliged to include any substance on the applicable list on the label if its concentration in the product exceeds a certain threshold - regardless of whether it comes from a fragrance composition, a natural essential oil or is a synthetic ingredient.

The most common mistakes to avoid:

• Omission of allergens from natural essential oils.
• No declaration, although the concentration exceeds the threshold of 0.001% or 0.01%.
• Omission of allergens from natural essential oils
• Incorrect substance designation in INCI
  

Importantly, the obligation to label only applies to those allergens that actually exceed the threshold values in the finished product. It is therefore essential to quantitative analysis by an experienced laboratory or accurate calculations of the content of individual allergens in the finished formula. It is on the basis of this data that it can be clearly determined which allergens to include on the label.

Rules for declaring:

• The INCI name of the fragrance allergen must comply with the list published in the Annex III to Regulation (EC) No 1223/2009
• Analysis of the data provided from the fragrance supplier (usually in the form of a list of allergens with their % contribution),
• If a product contains multiple fragrances, each must be analysed separately for allergen content.
• The concentration thresholds refer to the final product formulationand not the concentration of allergens in the raw materials or the fragrance composition.
  

If in doubt, it is worth commissioning additionalassessment of the composition of cosmetics before submitting the dossier for product registration.

Composition assessment vs. allergen determination

At the stage of assessing the safety of a cosmetic product, the expert takes into account not only the general properties of the individual substances, but also their sensitising potential. The dossier on fragrances must include data on the presence and concentration of allergens - their absence may mean that additions or corrections to the dossier are necessary.

Working with a laboratory that offers a comprehensiveregistration of cosmetics and supports the entire documentation process, avoiding problems at later stages.

How to prepare for the changes ahead?

The planned expansion of the allergen list is an issue that all cosmetics manufacturers should treat as a priority. The new substances required to be declared are often found in popular natural raw materials, such as tea tree oil or lavender oil. As a result, even products advertised as 'natural' may need to update their labelling to meet the new legal requirements and ensure full transparency to consumers.

Recommended actions:

• Verification of current formulations in the laboratory.
  
• Update labels and information material.
  
• Consultation with the team responsible for assessing the composition of cosmetics before the changes come into force.
  

Allergens in cosmetics - list of mandatory labels

Allergens in cosmetics - The list includes the specific names of the fragrances that, according to the regulation, must be declared if they exceed the concentration limits. It is useful to know not only the current list, but also the planned changes - as their implementation will be mandatory for all products on the market after the transition period.
The list of obligatory fragrance allergens in cosmetics is set out in Annex III of Regulation (EC) No 1223/2009 of the European Parliament and of the Council.
Manufacturers have a defined transition period to comply with the new requirements:

• From 31 July 2026. all cosmetics placed on the market must declare the new allergens if their concentration exceeds the threshold values (0.001% for leave-on, 0.01% for rinse-off).
  
• Products placed on the market before 31 July 2026. may remain on the market until 31 July 2028.but after that date they must comply with the new labelling requirements.
  

Adhering to these changes is important to ensure consumer safety and product compliance with current legislation.

If you need support in the correct labelling of allergens or want to prepare regulatory compliant documentation, contact ourcosmetics laboratory.