Cosmetic labels list their ingredients, with fragrance as the exception. A manufacturer may write the single word fragrance in place of the substances that make it up, and the same provision permits “and other ingredients” at the end of a list for anything the FDA has accepted as exempt from public disclosure, so one word can stand in for a list the buyer never sees. The European Union treats this differently, and in 2023 the European Commission adopted a rule requiring fragrance allergens to be named individually once they Page 2 of 3 exceed 0.001 percent in a product that stays on the skin or 0.01 percent in one that rinses off, adding 45 entries to the list of substances that must be declared.
The Commission’s scientific committee had identified 56 additional fragrance allergens “which have clearly caused allergies in humans.” The regulation describes contact allergy as “a life-long, altered specific reactivity in the human immune system,” estimates that between 1 and 9 percent of the EU population may be allergic to fragrance allergens, and states that a sensitized person reacts at concentrations below the permitted maximum.
The requirement is that the substances be named, so that a person who reacts to one can find it on the label and avoid it. Products that do not comply could be placed on the European market until July 31, 2026, and may remain available there until July 31, 2028. Congress directed the FDA to do the same, setting a deadline of June 29, 2024 in the Modernization of Cosmetics Regulation Act of 2022 for a rule naming the fragrance allergens that must be declared.
The agency missed it. The rule appears on the federal regulatory agenda as RIN 0910-AI90, Disclosure of Fragrance Allergens in Cosmetic Labeling, and as of this writing it has not issued. A product sold in both markets can therefore carry two ingredient lists, and the European one often names what the American one does not. Fragrance on a label is a category rather than an ingredient, stating that a scent was added without stating what was added, and a company that names its fragrance ingredients has done more than the rule requires.
Sources: 21 C.F.R. §§ 701.3, 720.8. https://www.law.cornell.edu/cfr/text/21/701.3 | Commission Regulation (EU) 2023/1545. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32023R1545 | Agenda entry RIN 0910-AI90. https://www.reginfo.gov/public/do/eAgendaViewRule? pubId=202510&RIN=0910-AI90
