Cosmereg, Author at Cosmereg

MoCRA – Cosmetic Direct Portal Live!

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 Cosmereg

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 Cosmereg

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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What is the Fragrance allergens update EU?

EU Cosmetic Regulations / By Cosmereg

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 Cosmereg

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

EU Cosmetic Regulations / By Cosmereg

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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FDA VCRP Discontinuation

USA Cosmetic Regulations / By Cosmereg

FDA Halts VCRP in Anticipation of Compulsory Cosmetics Registration The FDA’s latest cosmetic regulation update has shaken the beauty industry. According to the constituent update on March 27, 2023, cosmetic companies can no longer submit to the Voluntary Cosmetics Registration Program (VCRP). Now, they must use a new program currently in development by the FDA

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Proposed regulations for fragrance allergen ingredient labeling in Canada

Canada Cosmetic Regulations / By Cosmereg

Proposed regulations for fragrance allergen ingredient labeling in Canada Health Canada is proposing new regulations that would require fragrance allergen ingredient labeling on all cosmetic and personal care products sold in Canada. The proposal is aimed at increasing transparency and protecting consumers from potential allergic reactions to fragrance ingredients. Fragrance ingredients are commonly found in

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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 Cosmereg

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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FDA: 2023 Medical Device User Fees Announcement

Latest Medical Device User Fee Amendment (2023)

US FDA Medical Devices / By Cosmereg

FDA: 2023 Medical Device User Fees Announcement Medical device user fees for the Fiscal Year 2023 are now available following an announcement from the U.S. Food and Drug Administration (FDA). The fiscal year runs from October 1, 2022 – September 30, 2023. All medical device facilities must pay the new fee amounts to keep their

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Author name: Cosmereg