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.

MoCRA – Cosmetic Direct Portal Live!

USA Cosmetic Regulations / By

Innovating Compliance: FDA’s Cosmetics Direct Portal Live! Unveiling Cosmetics Direct: A Digital Revolution   In a stride towards modernization, the US Food and Drug Administration (FDA) has introduced Cosmetics Direct, an innovative electronic submission portal Cosmetics Direct. This digital platform is tailored exclusively for the registration and listing of cosmetic product facilities and products, aligning […]

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MoCRA: Roles of Responsible Person & US Agent in Cosmetic

USA Cosmetic Regulations / By

Embracing the Future: Responsible Person & US Agent in the Era of MoCRA    On December 29th, 2022, the cosmetic industry witnessed a groundbreaking change in regulatory requirements (21 U.S.C., Sec. 321-392), the most substantial update since 1938. This legislation, known as MoCRA, brings forth fresh obligations and signals a significant shift in how cosmetic

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How to get a DUNS number for food facility registration with the FDA

Step-by-Step Guide: Obtaining a DUNS Number for FDA Food Facility Registration

US FDA Dietary Supplements, US FDA food regulations, US FDA OTC regulations, USA Cosmetic Regulations / By

How to get a DUNS number for food facility registration with the FDA In the United States, both domestic and foreign facilities engaged in the manufacturing, processing, packing, or storage of food intended for human or animal consumption are required by law to register with the U.S. Food and Drug Administration (FDA). This registration process

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Fragrance allergens update EU

What is the Fragrance allergens update EU?

EU Cosmetic Regulations / By

Fragrance allergens update EU      The European Commission issued a new regulation (EU) 2023/1545 on July 27, 2023, updating the list of fragrance allergens in cosmetic products. Fragrance substances are commonly used in various cosmetic and household products, but they can cause contact allergies in some individuals. To protect consumers, the regulation aims for

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Post-Market Surveillance for Cosmetics in Europe and the USA

EU Cosmetic Regulations, USA Cosmetic Regulations / By

A Comprehensive Look at Post-Market Surveillance for Cosmetics in Europe and the USA   Cosmetics have become an essential part of our daily lives, with millions of people around the world using them every day. Cosmetics are used for various purposes, such as enhancing one’s beauty, maintaining personal hygiene, and improving overall well-being. However, the

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Update on UKCA Cosmetic Labeling and Marking Requirements: Extended Transition Period Announced by UK Government

Update on UKCA Cosmetic Labeling and Marking Requirements

EU Cosmetic Regulations / By

Update on UKCA Cosmetic Labeling and Marking Requirements: Extended Transition Period Announced by UK Government On November 14th, 2022, the Government of the United Kingdom made an important announcement regarding the transition period for UKCA cosmetic labeling and marking requirements. The deadline for compliance with UKCA marking requirements has been extended until December 31st, 2024.

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14 Key Questions About US Agents to Ensure Compliance with Medical Device Regulations

14 US Agent Questions to Know to Meet Medical Device Regulations

US FDA Medical Devices / By

14 Key Questions About US Agents to Ensure Compliance with Medical Device Regulations Medical device regulations must be met if you want to sell your products in the United States. The following questions and answers will help you meet these requirements. Read more : Embracing the Future: Responsible Person & US Agent in the Era

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Key Developments in EU and UK Regulations: Early 2023 Updates

EU Cosmetic Regulations / By

Key Developments in EU and UK Regulations: Early 2023 Updates 1. Recent Developments in Chemical Regulations In recent years, there has been growing scrutiny on the use and impact of chemicals in various aspects of modern life, with regulators and policymakers recognizing the role of innovative chemistry in addressing environmental challenges. The European Commission has

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