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EU Cosmetics Update – Omnibus Regulation VIII (EU) 2026/78 | Entry into force: 1 May 2026
The European Union has recently approved Regulation (EU) 2026/78 , also known as Omnibus Regulation VIII . This Regulation amends the current Regulation (EC) No 1223/2009 , introducing updates regarding the use of certain substances classified as CMR (carcinogenic, mutagenic, or toxic to reproduction). Entry into force / compliance deadline: 1 May 2026 From this date, no cosmetic products may be placed on the EU market if they do not comply with the restrictions listed belo
Daniel Jiménez
2 days ago3 min read
FDA moves forward with expanding the list of active ingredients for sunscreens
The U.S. Food and Drug Administration (FDA) has published a proposal to expand the list of permitted active ingredients in over-the-counter (OTC) sunscreens in the United States. This initiative is part of the agency's efforts to update the regulatory framework for sun protection and evaluate UV filters with a proven track record of use in other international markets.
Daniel Jiménez
Dec 30, 20252 min read
FDA: There is insufficient data to assess the safety of PFAS in cosmetic products
The US Food and Drug Administration (FDA) has published a report, required by Congress under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), evaluating the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products marketed in the United States.
Daniel Jiménez
Dec 30, 20252 min read
United Kingdom: New Restrictions on Hexyl Salicylate and CMR Bans
British authorities have notified the World Trade Organization (WTO) of a proposed amendment to the cosmetics regulations applicable in Great Britain, which introduces significant changes regarding ingredients. The amendment affects both the restriction of certain substances and the expansion of the list of ingredients prohibited by their CMR classification.
Daniel Jiménez
Dec 30, 20252 min read
Canada Moves Closer to the European Model on Allergens
Canada has confirmed the phased introduction of new fragrance allergen labeling requirements for cosmetic products, a change relevant to all brands that operate or want to operate in this market.
Daniel Jiménez
Dec 30, 20252 min read
FDA: Proposal to include bemotrizinol in the OTC monograph
This regulatory move is part of a broader FDA effort to modernize the monograph system for over-the-counter drugs—including sunscreens—and promote scientific innovation in sun protection formulations. Although the proposal remains open for public comment until January 2026, its progress has already generated interest among formulators and dermatologists, who see bemotrizinol as a tool for delivering more effective formulations with an improved sensory profile.
Daniel Jiménez
Dec 30, 20252 min read
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