Navigating Fragrance Allergens

Current Approach to Fragrance Allergens

Allergens are substances that induce immune responses in the body. Common results to skin allergens are irritation, redness, or even a breakout of hives or swelling. Though adverse skin reactions to cosmetics and fragrances may be classified as sensitivity rather than an allergy, to the sufferer there is little difference. Because the reactions between individuals can vary greatly and the reaction itself does not approach the severity of food allergens, fragrance/cosmetic allergen labeling may vary greatly. In the US, for example, the FDA cites allergic reactions to fragrances, but rather than requiring label declarations of individual components, they recommend consumers with fragrance sensitivities seek fragrance-free products.

IFRA Standards and Their Application in the US

US fragrance cosmetic formulators often rely on the IFRA standards on fragrances for a more proscriptive approach to fragrance ingredients. IFRA – the International Fragrance Association (ifra.org) regularly reviews fragrance ingredients and restricts or recommends specific usage to help protect consumer safety. Though not bound by regulatory requirements, most global fragrance formulators and cosmetic manufacturers adhere to IFRA guidelines. To date, IFRA has identified ~4000 ingredients used as fragrances including natural oils and extracts. IFRA provides guidance on select materials where they feel there is some safety concern. IFRA may designate ingredients as prohibited – not to be used as fragrances, restricted – to be used only in proscribed applications at the concentrations recommended, or specified – held to specified purity criteria. When selecting fragrance ingredients, many global firms confirm they meet the IFRA criteria, using only IFRA-identified fragrances at the recommended use level and specifications.

EU Regulation 1223/2009 and Labeling Requirements

The EU regulates fragrances under the cosmetic regulation EU 1223/2009. Like IFRA, the EU classifies cosmetic ingredients as prohibited or restricted. The EU classifies over 1300 materials as prohibited. These substances, including many fragrances, are not to be used in cosmetics. European regulations do allow for small quantities of prohibited substances, only where such trace impurities are technically unavoidable under good manufacturing practice (GMP) conditions. Materials identified as restricted should be used only in the proscribed products in conditions and concentrations identified in the regulation.

Of the restricted materials identified in the EU regulation, 26 are singled out for labeling purposes. Cosmetic ingredient lists must indicate the presence of these 26 materials if they exceed a concentration of 0.001% in leave-on products or exceed 0.01% in rinse-off products. These 26 materials are often considered the major fragrance allergens and must be identified so consumers who are sensitive to these materials have the knowledge needed to avoid products containing them. The EU distinguishes different concentration limits for labeling between leave-on products and rinse-off products, because the prolonged exposure to allergens in leave-on products can induce the a negative reaction at lower concentrations in sensitive individuals.

IFRA vs EU Regulation 1223/2009

There is considerable overlap between the IFRA and the EU restricted materials lists, but some gaps are present between the two. The EU regulation includes all potential ingredients in cosmetics, such as preservatives, in addition to fragrances. Additionally, some materials considered restricted or prohibited in the EU may not be designated as such by IFRA. For example, the almond/cherry-fragranced molecule benzaldehyde is identified as restricted by IFRA. They recommend different maximum concentrations based on the application, such as ≤0.2% in deodorants/antiperspirants and ≤3% in rinse-off hair conditioner. The EU regulation, on the other hand, does not cite benzaldehyde as restricted or prohibited.

The Future of Fragrance Allergens

As fragrance becomes more ubiquitous in cosmetics and household products, and more data is collected on the sensitivity of people to fragrance molecules, a better understanding of their safe use is gained. Restricted or suggested use lists may increase. The European Commission Scientific Committee on Consumer Safety (SCCS), for example, published a report in 2012 recommending an expansion of the allergens/sensitizers identified in the EU cosmetic regulation.¹ This report identified 82 substances with established skin sensitivities in humans, another 19 substances with established skin sensitivities in animals, and 26 substances with likely skin sensitivities. The SCCS recommends identifying the presence of any of these 127 materials on cosmetic labels, so consumers sensitive to them can make informed purchasing decisions. The SCCS list includes substances which already require labeling in the EU as well as substances on the EU and/or IFRA list of restricted or prohibited substances.

The proscriptive approach of IFRA and EU regulations has been recommended by consumer groups in the US and is starting to take statutory roots. California recently passed State Senate Bill No 258 (SB 258) which requires any cleaning products sold in California to include on its label a list of fragrance allergens. Interestingly, the cited list of allergens is the list of restricted substances in the EU cosmetic regulations.

Due to safety concerns and a drive for consumer protection, there is a growing trend to evaluate fragrance ingredients for safety. Even where the fragrance ingredient is harmless for most individuals, since some people may experience irritation, swelling, or other sensitivity reactions to ingredients, regulatory agencies are requiring clear identification and regulation of fragrance ingredients. Non-governmental organizations such as IFRA offer considerable guidance on fragrance use and labeling. By following IFRA and the regulatory bodies, manufacturers can provide beautifully scented cosmetics and household products that are safe and welcoming for all consumers.

What to Expect from Sigma-Aldrich^® Fragrance Ingredients

To drive further transparency with our aroma chemicals, our ingredients are verified to follow the guidelines designated by IFRA and meet the EU Regulation 1223/2009. We perform a thorough review of the following:

• Verify that ingredients do not contain any prohibited substances identified in Annex II of EU 1223/2009 or in the IFRA standard.
• Review for presence of restricted substances in EU 1223/2009 and, if present, list under “Composition” in the Properties table of the material
• Products are specified as “Follows IFRA Guidelines” when present on the IFRA Transparency List and reviewed against the IFRA standard for specified, restricted and prohibited substances
• Review for presence of IFRA specified and restricted substances and, if present, list under “Composition” in the Properties table of the material
• The aroma chemicals designated as “Follows IFRA Guidelines” will have an IFRA and Fragrance Allergen Statement provided

View our aroma chemicals that “Follows IFRA Guidelines” by clicking here.