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.

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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New Zealand Cosmetic Regulations 2026

New Zealand Cosmetic Regulations 2026

New Zealand Cosmetic Regulations 2026: Compliance Guide for Brands & Importers New Zealand has introduced major updates to cosmetic regulations, with new requirements becoming enforceable from 1 January 2026. These changes affect cosmetic manufacturers, importers, brand owners, and distributors placing products on the New Zealand market. The updated rules strengthen ingredient controls, expand the regulatory

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FDA Draft Guidance on Mandatory Cosmetic Recalls Under MoCRA: What Brands Must Know

FDA Draft Guidance on Mandatory Cosmetic Recalls Under MoCRA: What Brands Must Know On 18 December 2025, the U.S. Food and Drug Administration announced the availability of a new draft guidance document titled “Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry.”This guidance represents a critical enforcement clarification under the Modernization of Cosmetics Regulation

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Health Canada Proposes 2025 Updates to the Cosmetic Ingredient Hotlist – What Cosmetic Brands Need to Know

Health Canada Opens Consultation on the Cosmetic Ingredient Hotlist (November 2025) On November 19, 2025, Health Canada announced a public consultation to update the Cosmetic Ingredient Hotlist, the country’s reference list of ingredients prohibited or restricted in cosmetics.This update aims to reflect the latest toxicological data and risk assessments under the Chemicals Management Plan (CMP).

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Proposition 65 titanium dioxide

California Prop 65: Safe Harbor Levels for Titanium Dioxide

California Adopts Proposition 65 Safe Harbor Levels for Titanium Dioxide California has officially established Safe Harbor exposure limits for titanium dioxide (airborne, unbound particles of respirable size) under Proposition 65 — the state’s law requiring businesses to warn consumers about potential exposure to chemicals linked to cancer or reproductive harm. New Safe Harbor Limits According

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US FDA Updates Food Labeling Compliance Program: What Manufacturers Need to Know

FDA Updates Food Labeling Compliance Program: What Manufacturers Need to Know The U.S. Food and Drug Administration (FDA) has released major revisions to its Compliance Program 7321.005, now titled “General Food Labeling Requirements and Labeling-Related Sample Analysis – Domestic and Import.” This update, issued on June 24 2025, replaces the previous 2010 version and marks

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California SB 236 Hair Relaxer Bill – What Cosmetic Brands Must Know

California SB 236 Hair Relaxer Bill: What It Means for Cosmetic Brands California has once again taken the lead in cosmetic safety with the introduction of SB 236, the Hair Relaxer Bill (C.U.R.L. Act). This new law is set to reshape how hair relaxer products are formulated, tested, and sold in California. If your brand

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FDA FAERS Public Dashboard for Cosmetic Products

  FDA Launches FAERS Public Dashboard for Cosmetic Products: Transparency in Adverse Event Reporting On September 12, 2025, the U.S. Food and Drug Administration (FDA) introduced the FAERS Public Dashboard for Cosmetic Products, a new interactive platform designed to improve cosmetic safety monitoring and transparency. This tool gives real-time access to adverse event reports related

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