EU cosmetic allergen rules:
Impact on cosmetic formulation

In July of 2023, the European Union (EU) adopted new allergen rules for cosmetics, expanding their list of fragrance allergens from 26 substances to 82. This change has had a wave of repercussions throughout the personal care industry, impacting both new product launches and existing products alike.

One of the biggest issues has been how these allergen rules impact natural and ‘clean’ formulas, since plant materials and essential oils contain many of the newly listed allergen components as well as synthetic fragrances and flavours. 

Just how have the updated EU allergen rules impacted cosmetic formulations, and what more does your cosmetic brand need to be doing right now? Read on to find out…

Consumers have had a heightened sense of safety and wellbeing around their personal care product choices for some time. While many cosmetic ingredient concerns have been based on fear mongering tactics of the past, the fact is, the revised allergen rules for cosmetics have caused a significantly longer ingredient listing, using botanical names as well as chemical names.

For consumers with allergies, this information is very helpful. However, for the vast majority of consumers without allergies, the expanded ingredients panel can give a negative perception of the number of ingredients a cosmetic product contains as well as how chemical, or hazardous, its ingredients may be.

For cosmetic brands, this means re-educating consumers on what must be present on a cosmetic label as well as expanded information on what each ingredient (or component) listed on the product label may be derived from or used for. It can also pose significant issues for the artwork department to fit all required information on what is often already limited space on a product label or its packaging.

In all cases, it means many hours of additional work across a cosmetic brands’ marketing and art departments in conveying not only the required information to a consumer, but additional information to allay concerns and justify an ingredient deck for consumer purposes. This all adds to the time and costs of development and promotions of a cosmetic product.

For example, for a simple body lotion containing lavender and palmarosa essential oils, an ingredient list, unfragranced, would expand from:

Aqua, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Glycerin, Isopropyl Myristate, Ceteareth-20, Stearic Acid, Carbomer, Diazolidinyl Urea, Iodopropynyl Butylcarbamate, Sodium Hydroxide.

To this, where required allergen INCI names are provided:

Aqua, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Glycerin, Isopropyl Myristate, Ceteareth-20, Stearic Acid, Carbomer, Lavandula Angustifolia Oil, Cymbopogon Martini Oil, Alpha-Terpinene, Beta-Carophyllene, Citral, Farnesol, Geraniol, Geranyl Acetate, Lavandula Oil/Extract, Limonene, Linalool, Linalyl Acetate, Pinene, Terpineol, Terpinolene, Diazolidinyl Urea, Iodopropynyl Butylcarbamate, Sodium Hydroxide.

(This is an example based on standard information for 0.7%w/w and 0.3%w/w inputs of essential oils listed – specific examples may vary slightly based on individual supplier data). 

Even if a cosmetic product has a long history of sale, it still needs to comply with the updated EU allergen rules for cosmetics by July 31, 2028. While this may sound simple, for every single cosmetic product in a company’s range, it means, at the very least:

• obtaining updated allergen statements from suppliers of all botanical extracts, essential oils, fragrance and flavour components of a cosmetic formula;
• creating updated Product Information Files (PIFs) and Cosmetic Product Safety Reports (CPSRs) to reflect the updated allergen information;
• uploading this new information to the Cosmetic Product Notification Portal (CPNP); and
• updating ingredient declarations on packaging – this in itself requires regulatory updates and checks, artwork revisions and approvals and new packaging and/or labels to be printed.

In some cases, where a supplier is unable to provide required updated allergen information, it may mean changes to ingredients used or the suppliers themselves, which can then mean returning to the bench for sample and formulation development as well as the document collation, report preparation and updated printed items listed above.

For cosmetic brands, it means any product in their existing range that they wish to carry forward needs a detailed check, in some cases reformulation consideration, and in all cases significant regulatory work and revised document collection. 

For all new cosmetic product launches since July 31, 2026, the new allergen requirements apply. For some cosmetic brands, particularly those promoting natural, organic or ‘clean’ beauty philosophies, the labelling and marketing impacts have been the most significant. For all cosmetic brands, however, it means an increased regulatory burden as extra documents are collected and extended allergen statements compiled.

While new product launches don’t require the rework steps, it does mean more detailed document collection and preparation from the start, and extended ingredient panels on packaging. It can also mean a ‘rethink’ on the use of some botanical ingredients, fragrances and flavours, to reduce the consumer perception of extended ingredient listings.

There has been a strong consumer push for more natural formulations in recent years, including the use of natural essential oils and botanical materials. However, the reality of the revised EU cosmetic allergen rules for many brands could mean the need to limit the use of these materials to lessen the regulatory, consumer and marketing impacts.

When you are considering new cosmetic launches, it could mean consulting with your Cosmetic Chemist and Regulatory Departments before specifying the use of desired botanical ingredients, essential oils, fragrances and flavours. As a Cosmetic Chemist or in the Regulatory Department, it means sourcing additional documentation and approvals, as well as more time needed in preparing crucial PIFs and CPSRs. In all cases, it is the final label that will carry the most impactful message to your valuable consumers in an already misinformed and wary marketplace.

Make sure your cosmetic brand considers the needs and benefits of using botanical ingredients, essential oils, fragrances and flavours – both natural and synthetic – because the additional time and costs involved with their use can no longer be underestimated. 

Happy formulating! 

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