Allergens in cosmetics, the European requirements

According to the EU cosmetics regulation, cosmetic products should list their ingredients on the packaging. However, perfume aromatic compositions and their raw materials are referred to as ‘parfum’ or ‘aroma’. Substances for which the cosmetics regulation provides individual labelling are an exception to this terminology. At the moment, 26 fragrance allergens are subject to individual labelling. You can download the list of allergens here. 

But how do you find out whether your product contains any of the allergens and what to do if it does? Read on to find out.

Why do you need to include fragrance allergens on a cosmetic product label?

The objective of EU cosmetic regulation is to protect consumers, for this reason, cosmetic manufacturers are required to list certain substances that are known allergens. This helps consumers identify products that could potentially cause issues for them. Correct labelling not only helps customers avoid problematic products, but it also helps cosmetic product manufacturers reduce the number of complaints or unhappy customers and protect reputation! The listing has shown to be important in the clinical management of patients who are allergic to one or more of these 26 fragrance chemicals.

The last thing you want is your valued customers turning their back on you because they were not informed about allergen content.

How to find out whether your product contains any of the 26 allergens?

As the list contains fragrance allergens, chances are fragrance-free products will not contain any of the listed substances. But it is worth asking the supplier of ingredients for allergen certificates to be on the safe side as some of the allergens can be found e.g. in honey.

Most of the allergens listed are of natural origin and are components of popular essential oils. When using essential oils in formulations it is a must to have allergen certificate provided by the ingredient supplier. Reputable suppliers will have them on file and share them with you. 

What to do if your product contains any of the allergens?

Now you know how to identify the allergens present in your product, but does it mean all of them must be listed on the label? The short answer is no! It depends on the quantity of the allergen in the finished formulation. The thresholds are 0.001% for leave-on products and 0.01% for rinse-off products.

To calculate the final amount of the allergenic substance in a cosmetic product you'll need to know its content in the individual ingredients. Reputable ingredient suppliers will be able to share this information with you.

Please note that all Cosmetic Product Safety Reports (CPSR) prepared by us provide you with the calculation and recommendation regarding allergen labelling.

Please get in touch via info@moleculeregulatoryservices.co.uk for further information on labelling or other regulatory topics like CPSR (Cosmetic Product Safety Report).

Watch this space for upcoming blog posts exploring further aspects of cosmetic regulations and how to make and sell your cosmetics in a safe and compliant way. We will make it simple!

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