Author name: Pasquale Carvelli

Pasquale Carvelli is a Regulatory Strategy & International Compliance Advisor for Cosmereg, an international regulatory affairs company supporting manufacturers, distributors, and brand owners navigating complex compliance frameworks across multiple jurisdictions. Through a multidisciplinary network of certified safety assessors and regulatory experts, he oversees strategic compliance pathways for cosmetic, food, and supplement products entering regulated markets.

Bemotrizinol joins the FDA sunscreen monograph

Bemotrizinol joins the FDA sunscreen monograph — and why the pathway matters more than the molecule On 9 June 2026, the US Food and Drug Administration issued a Final Administrative Order adding bemotrizinol to the over-the-counter sunscreen monograph. Most of the coverage has framed this as a new ingredient arriving in America. For a regulatory […]

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The 31 July 2026 EU Fragrance Allergen Deadline

The 31 July 2026 EU Fragrance Allergen Deadline — and the Batch Trap Most Brands Miss For two decades, the EU asked cosmetic brands to call out a familiar set of 26 fragrance allergens on the label. That settled world ends on 31 July 2026. From that date, the significantly expanded fragrance allergen list introduced

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Selling Cosmetics on Amazon: What You Need to Know

Selling Cosmetics on Amazon: 2026 FDA MoCRA Compliance Guide

Selling Cosmetics on Amazon: 2026 FDA MoCRA Compliance Guide Reviewed by Pasquale Carvelli — Regulatory Strategy & International Compliance Advisor, Cosmereg · Last updated: 15th of June 2026 Amazon is one of the largest beauty marketplaces in the world — a search for “cosmetics” returns tens of thousands of listings. But selling makeup, skincare, body

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Is Your Cosmetic Product at Risk? PFAS Decision Guide for Brands

Is Your Cosmetic Product at Risk? A PFAS Decision Guide for Cosmetic Brands By now, most cosmetic professionals know that PFAS — the so-called “forever chemicals” — are facing tightening rules. The harder question isn’t whether PFAS matter, but what a brand should actually do about them. Not every product carries the same exposure, and

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OMUFA FY 2026: FDA OTC Drug User Fees, Rates & Key Deadlines

OMUFA FY 2026: FDA OTC Drug User Fees, Rates & Key Deadlines The FDA has published the fiscal year 2026 fee rates under the Over-the-Counter Monograph Drug User Fee Amendments (OMUFA II). The headline changes: facility fees for OTC monograph drug manufacturers have dropped approximately 50% compared to FY 2025, while OTC Monograph Order Request

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Cosmetic Notification Form CNF Canada

Cosmetic Notification Form (CNF) Canada: 2025–2026 Complete Filing Guide

Cosmetic Notification Form (CNF) Canada: 2025–2026 Complete Filing Guide Last updated: March 2026 If you sell cosmetics in Canada — or plan to — filing the Cosmetic Notification Form (CNF) with Health Canada is not optional. It is a legal requirement under the Food and Drugs Act and the Cosmetic Regulations, and failure to comply

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Proposed regulations for fragrance allergen ingredient labeling in Canada

Canada Fragrance Allergen Labeling 2026: Requirements, Deadlines & Compliance | Cosmereg

Canada Fragrance Allergen Labeling 2026: Requirements, Deadlines & Compliance Guide Last updated: March 2026 If you manufacture, import, or sell cosmetics in Canada, a significant labeling deadline is fast approaching. Starting April 12, 2026, Health Canada requires cosmetic brands to disclose specific fragrance allergens directly on product labels — a major shift from the previous

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FDA Cosmetics Registration Renewal 2026: What You Need to Know

FDA Updates Cosmetics Direct Portal for Biennial Registration Renewal Under MoCRA On 11 February 2026, the U.S. Food and Drug Administration (FDA) announced significant updates to its Cosmetics Direct electronic submission portal, along with revised user guides and instructional materials. These updates are designed to support cosmetic product facilities through their first biennial registration renewal

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UK Cosmetics Regulation 2026: 4-MBC Ban, CMR Substances & New Labelling Rules

UK Amends Cosmetics Regulation with New Ingredient Prohibitions and Restrictions (SI 2026/23) On 15 January 2026, the UK Government laid before Parliament a significant amendment to the retained UK Cosmetics Regulation. The Cosmetic Products Regulation (EC) No 1223/2009 (Restriction of Chemical Substances) (Amendment and Transitional Provisions) Regulations 2026, known as SI 2026/23, introduces sweeping changes

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FDA dietary supplement health claims

Legal Challenge to FDA’s Evidentiary Standard for Dietary Supplement Health Claims: Regulatory Implications for Industry

The FDA dietary supplement health claims framework requires that disease-related claims meet the Significant Scientific Agreement (SSA) standard under 21 CFR 101.14. A recent legal challenge questions whether the SSA threshold is overly restrictive, potentially impacting dietary supplement compliance and claim substantiation requirements.

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