On July 3, 2026, in the newly released “2026 Regulatory Plan and Unified Agenda,” the US Food and Drug Administration (FDA) placed two important cosmetics-related rules in the “Proposed Rule Stage,” with the aim of issuing Notices of Proposed Rulemaking (NPRM) in 2026: first, to prohibit the use of formaldehyde and formaldehyde-releasing chemicals in hair smoothing/straightening products (RIN 0910-AI83); and second, to require the disclosure of fragrance allergens on cosmetic product labels (RIN 0910-AI90).
Background
The “Regulatory Plan” and the “Unified Agenda” are official documents in which US federal agencies periodically disclose their ongoing regulatory rulemaking projects. They are published by the Regulatory Information Service Center of the General Services Administration (GSA) on reginfo.gov (and concurrently in the Federal Register).
The principal legal basis for cosmetics-related rulemaking is the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which granted the FDA new authorities over cosmetic labeling, safety, and good manufacturing practices. A rule typically must go through the process of “NPRM publication → public comment → final rule” before it can take effect.
Key Contents
Module 1-Restricting Formaldehyde: Prohibiting Formaldehyde and Formaldehyde-Releasing Chemicals in Hair Smoothing/Straightening Products (RIN 0910-AI83)
The full title of this proposed rule is “Use of Formaldehyde and Formaldehyde-Releasing Chemicals as an Ingredient in Hair Smoothing Products or Hair Straightening Products.” The rule would prohibit the use of formaldehyde and formaldehyde-releasing chemicals (e.g., methylene glycol) as an ingredient in hair smoothing/straightening products marketed in the United States that are applied to the hair and heated under their conditions of use. Such products release formaldehyde gas during use (e.g., when heated with a flat iron), and prolonged exposure has been linked to health risks in a number of studies. The target publication date for this NPRM is listed as November 2026 (the FDA has previously postponed the publication of this rule on multiple occasions).
Module 2-Fragrance Allergen Disclosure: Requiring Fragrance Allergen Labeling on Cosmetic Products (RIN 0910-AI90)
The full title of this proposed rule is “Disclosure of Fragrance Allergens in Cosmetic Labeling.” The FDA proposes to identify certain substances as fragrance allergens and to require the disclosure of fragrance allergen information on cosmetic product labels, so that consumers can identify and avoid them. This NPRM is also targeted to be published in November 2026.
CIRS Reminder
Both of the above rules are currently at the proposed stage; the final text and effective dates are subject to the versions actually published in the Federal Register. CIRS Group offers the following reminders:
- Limited scope of the formaldehyde ban: this rule targets hair smoothing/straightening products (including situations where formaldehyde is released when heated), and is not a “comprehensive ban on formaldehyde in all cosmetics”; companies should delineate the affected products according to the official scope.
- Advance compliance preparation for fragrance allergen labeling against global standards: Multiple key markets such as EU and Canada have updated and expanded regulated fragrance allergen lists. Cosmetic companies can conduct early reviews of formulas and labels based on mature international regulatory inventories to reserve adjustment lead time prior to the enforcement of new finalized cosmetic regulations.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
Our Services
- The United States Agent
- The United States FDA Cosmetic Facility Registration
- The United States FDA Cosmetic Product Listing
- The United States FDA OTC Drug Registration
- The United States Color Additive Batch Certification
- The United States Cosmetic/OTC Drug Labeling Review
- International Cosmetic Ingredient Name (INCI) Application
Further information:
