What are Fragrance Allergens?

By: Deeksha Chahal, JUNIOR REGULATORY AFFAIRS ASSOCIATE, email

Fragrances are all around us from perfumes and colognes to scented products like candles and even household products like laundry detergents and fabric softeners. Fragrances are sourced from both synthetic chemical substances as well as natural extracts like essential oils. Unfortunately for some individuals, these can trigger a fragrance allergy, causing allergic reactions ranging from mild contact dermatitis to severe respiratory issues and asthma symptoms.

Understanding the potential allergens contained in fragranced products is crucial not only for those who experience allergy symptoms, but also for consumers who wish to make informed choices about the products they use and company’s developing and selling cosmetic products.

In this blog, we’ll delve into the world of fragrance allergens. We’ll review Health Canada’s proposed regulations they relate to cosmetic fragrance ingredient disclosure, providing comprehensive list to help you identify them. But first, what is a fragrance allergen?

What are Fragrance Allergens?

Fragrance allergens are substances that can cause allergic reactions when they come into contact with the skin or are inhaled.

Fragrance allergies are generally less common than seasonal allergies. However, they impact enough people that you’ll notice many places serving the general population post signs to advertise that their space is “fragrance free”. Your employer may also ask you to refrain from wearing perfumed consumer goods if one of your co workers has identified that they have a fragrance allergy.

Allergic Reactions and Allergy Symptoms

Fragrance allergies can have widely varying symptoms. Some examples include:

• itching
• redness
• swelling
• respiratory distress

Fragrance allergens are often found in perfumes, cosmetics, personal care products, household products like cleaners, and air fresheners.

Fragrance Allergens Proposed “Draft Regulation” and List

The Regulations Amending Certain Regulations Concerning the Disclosure of Cosmetic Ingredients (“the draft Regulations”) was published in the Canada Gazette, Part I, on Feb. 11, 2023. The draft Regulations was open for consultation until April 22, 2023.

The articulated goal for the proposed regulatory changes is to increase the chemical transparency, improve the regulatory oversight, and address administrative updates for cosmetics, while continuing alignment with the regulatory framework of the European Union (EU) concerning cosmetic product labeling.

Since 2006, cosmetic product labels have been required to list all ingredients present in the formulation for the product, primarily using internationally recognized nomenclature for cosmetics called INCI. This practice has been in alignment with the same naming conventions used in the EU, and similar requirements in the United States and other jurisdictions. However, one notable exception has been with respect to the declaration of fragrance ingredients and associated allergens.

The proposed “draft regulations” main points are as follows:

1. Introduce a requirement to disclose particular fragrance allergens on cosmetic labels when present in a quantity exceeding a specified threshold.
2. Fragrance allergens to be disclosed when present at a concentration >0.01% in rinse-off products and >0.001% in leave-on products.
3. Fragrance allergens to be disclosed within the list of ingredients on cosmetic labels.
4. Fragrance allergens would be those set out in the European Restricted Substances List (i.e. Annex III, titled List of Substances Which Cosmetic Products Must Not Contain Except Subject to The Restrictions Laid Down, of Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products), which would be incorporated by reference into the Cosmetic Regulations.

On July 26^th 2023, the European Union (EU) adopted Regulation (EU) 2023/1545 to update labelling of fragrance allergens under Annex III to Regulation (EC) 1223/2009 on cosmetic products.

The below table shows the expanded list of fragrance allergens

Fragrance Allergy List

Potential impacts on people in Canada, including businesses

These amendments are expected to increase consumer protection, particularly for vulnerable individuals with sensitivities to fragrance allergens, through the mandated disclosure of specific fragrance allergens on product labels.

The cosmetic industry will be impacted by the amendments, as the changes will introduce label updates to many cosmetic products. Health Canada will determine an appropriate coming-into-force strategy and other solutions, such as a digital ingredient labelling option for products sold in small packages, to reduce the burden on industry.

Additionally, these proposed amendments aim to enhance the efficacy of the department’s risk assessments and reinforce existing enforcement protocols, with anticipated effects on industry operations expected to be minimal.

What should businesses do?

Be Proactive.  Start contacting your fragrance suppliers now and ask them to provide you with a list of allergens in their fragrances.  This will give you a head start on potential label changes and help you develop a strategy on managing these changes.

How Dell Tech Can Help with Fragrance Allergens and Cosmetic Products

Dell Tech Laboratories has professionals with experience in cosmetic regulations. Please contact us with any questions or concerns with respect to how these proposed changes may impact your business or how to get involved with the Health Canada consultation.

Dell Tech has provided professional, confidential consulting services to the specialty chemical 

industry in Canada, the USA, Europe, and Asia for the last 40 years.