Ottawa, May 19, 2025. Health Canada has released a Notice to Stakeholders outlining the changes it intends to make to its Cosmetic Ingredient Hotlist , the administrative list that indicates which substances are prohibited or restricted in cosmetic products sold in the country. The notice comes three months before the official draft goes out for public comment and offers manufacturers and distributors the opportunity to review their formulas in advance.

The European Commission has notified the World Trade Organization (WTO) of the draft regulation that will amend Regulation (EC) 1223/2009 to incorporate the substances recently classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) by the 22nd Adaptation to Technical Progress (ATP 22) of the CLP Regulation

The regulation, dated May 12 and published in the EU Official Journal on May 13, 2025, updates the list of banned substances and introduces significant changes that will affect manufacturers, importers and distributors in the cosmetics sector.

The United Kingdom (UK) has notified the World Trade Organization (WTO) of its intention to amend Regulation (EC) No 1223/2009 , as applied to Great Britain, to limit the concentration of benzophenone-3 (BP-3) in various cosmetic products. The proposal—notified by notification G/TBT/N/GBR/102 of 8 May 2025—is based on the recent opinion of the Scientific Advisory Group on Chemical Safety (SAG-CS), which concluded that the substance is safe within specific thresholds.

An OTC (Over-the-Counter) Monograph from the U.S. Food and Drug Administration (FDA) is the set of technical and legal requirements that allow an over-the-counter drug to be marketed without having to submit an individual New Drug Application (NDA).

This guide will address, in a streamlined and practical way, both the fundamentals of SPF (mechanisms of action, filter types, and evaluation criteria) and the main legal and labeling requirements in the most relevant markets, so you can design, develop, or select safe formulas that comply with current regulations.