California Greatly Expands List of Cosmetics Fragrances Reportable as Allergens

Since January 1, 2022, California’s Fragrance and Flavor Ingredients Right to Know Act of 2020 has required manufacturers of cosmetic products to disclose the following information to the California Department of Public Health (CDPH):

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  1. Any fragrance or flavor ingredients present in a cosmetic product and included in one or more of 22 “designated lists” of hazardous chemicals issued by various authoritative bodies.
  2. Any fragrance allergen present in a cosmetic product and included in Annex III of the European Union’s (EU) Cosmetics Product Regulation No. 1223/2009 (the 23rd “designated list”) and its subsequent updates if the ingredient is present in a rinse-off product at a concentration at or above 0.01% (100 ppm) or in a leave-on product at a concentration at or above 0.001% (10 ppm).

The term “cosmetic product” is defined as “an article for retail sale or professional use intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance,” so it also encompasses most or all personal care products.

The specific fragrance ingredients and fragrance allergens covered by (1) and (2) may be found in the Reportable Ingredients List (RIL) established by the California Safe Cosmetics Program (CSCP). The fragrance allergens are separately identified in order to show that they are hazardous only to individuals who suffer from fragrance allergies. Until very recently, the RIL contained only 26 such fragrance allergens. However, in late March that number was increased more than three-fold to 80, with the addition of 56 more fragrance allergens and the delisting of just two from the original list. This list expansion comes as a result of the publication in July 2023 of Regulation (EU) 2023/1545, which amended the EU’s Regulation 1223/2009 by adding 56 fragrances that the European Commission’s Scientific Committee on Consumer Safety had earlier identified as having “clearly caused allergies in humans.”

The list of 56 reportable fragrance allergens newly added to the RIL under the Right to Know Act includes such familiar fragrances as menthol, vanillin, camphor, lemongrass oil, methyl salicylate (wintergreen), terpineol, jasmine oil/extract, Mentha piperita (peppermint) oil, Lavandula (lavender) oil, and rose flower oil/extract.

In its disclosure to the CDPH, a manufacturer must identify not only the listed fragrance/flavor ingredient or fragrance allergen but also the cosmetic product in which it is present. CDPH then publishes that information in a consumer-friendly database. However, a manufacturer is not required to disclose the weight or amount of the ingredient or allergen, or the manner in which the ingredient, allergen or product is formulated, since these are considered to be trade secrets. For reporting the newly included allergens, manufacturers may follow the timeline established in the 2023/1545 EU Regulation, namely no later than July 31, 2026, for placing affected cosmetics on the market and July 31, 2028, for making them available on the market, although they may report at any time prior to those deadlines.

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