Author name: Cosmereg

The Role of the US FDA Agent for Cosmetics, OTC and Drug Products

Understanding the Role of a US FDA Agent for Cosmetics, OTC, and Drug Products

The Role of the US FDA Agent for Cosmetics, OTC and Drug Products If you’re a foreign manufacturer of Cosmetics and OTC medications and prescription drug products, appointing a US Agent for FDA purposes is crucial. But what exactly does a US FDA agent do?   First of all check here the difference between a cosmetic, […]

Understanding the Role of a US FDA Agent for Cosmetics, OTC, and Drug Products Read More »

Mastering Compliance: A Step-by-Step Guide for Obtaining a FEI and Adhering to MoCRA and FDA Regulations in the Cosmetic Industry

Guide for Obtaining a FEI MoCRA FDA Cosmetics

Mastering Compliance: A Step-by-Step Guide for Obtaining a FEI and Adhering to MoCRA and FDA Regulations in the Cosmetic Industry     Unlocking the Potential of the FDA Establishment Identifier (FEI) in the Dynamic Cosmetic Industry In a groundbreaking move, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was officially implemented into existence on

Guide for Obtaining a FEI MoCRA FDA Cosmetics Read More »

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

MoCRA – Cosmetic Direct Portal Live! Read More »

MoCRA: Roles of Responsible Person & US Agent in Cosmetic

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

MoCRA: Roles of Responsible Person & US Agent in Cosmetic Read More »

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

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

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

Fragrance allergens update EU

What is the Fragrance allergens update EU?

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

What is the Fragrance allergens update EU? Read More »

Post-Market Surveillance for Cosmetics in Europe and the USA

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

Post-Market Surveillance for Cosmetics in Europe and the USA Read More »

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

Update on UKCA Cosmetic Labeling and Marking Requirements

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.

Update on UKCA Cosmetic Labeling and Marking Requirements Read More »

Proposed regulations for fragrance allergen ingredient labeling in Canada

Proposed regulations for fragrance allergen ingredient labeling in Canada

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

Proposed regulations for fragrance allergen ingredient labeling in Canada Read More »

Scroll to Top