FDA cosmetics

September regulatory roundup

EU News EU Issues Draft Regulation on Cosmetic Ingredients: New Classifications May Lead to Restrictions On 25 September 2024, the European Union issued a draft Regulation representing the 23rd Adaptation to Technical and Scientific Progress (ATP) under the Classification, Labelling, and Packaging (CLP) Regulation. This draft focuses on classifying eight chemical substances, several of which are widely used in cosmetics and other sectors. […]

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Cosmetics Direct FDA Portal for Cosmetic Product Listing is Live

The U.S. Food and Drug Administration (FDA) has launched Cosmetics Direct on 18 December! Cosmetics Direct is an electronic portal for registering and listing cosmetic product facilities and products. This initiative, mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), aims to streamline the submission process for the industry. Cosmetics Direct provides a

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FDA’s New Reporting Standards for Cosmetic Adverse Events

The FDA has announced significant updates for reporting severe adverse events in cosmetics, as required by the 2022 Modernization of Cosmetics Regulation Act (MoCRA). These important changes, affecting manufacturers, packers, and distributors, will become enforceable on December 29, 2023. Key points of the FDA’s update include: This update signifies a significant step in ensuring consumer

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Major Updates in Cosmetic Regulations USA: What You Need to Know

The Modernization of Cosmetic Regulations Act of 2022 (MoCRA) Brings Significant Changes In a landmark move to ensure consumer safety, the Modernization of Cosmetic Regulations Act of 2022 (MoCRA) has introduced pivotal changes to the cosmetic industry’s regulatory framework. These modifications, effective from December 29, are a result of amendments to Chapter VI of the

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FDA Delays Enforcement of Cosmetic Registration Requirements: What You Need to Know

The U.S. Food and Drug Administration (FDA) has recently made an important announcement that will have a significant impact on the cosmetic industry. In a move aimed at providing the industry with additional time to meet compliance requirements, the FDA has decided to delay the enforcement of the cosmetic product facility registration and product listing

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MoCRA – which businesses qualify for exemption?

MoCRA (Sec. 612) exempts certain small businesses from GMP, facility registration and product listing. Small businesses are defined as businesses with average gross annual sales of cosmetic products in the USA for the previous 3-year period of less than $1,000,000 (adjusted for inflation). However, this exemption does not apply to facilities producing cosmetic products that:

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What you need to know when making cosmetic claims in the USA

Cosmetic claims represent an important part of cosmetic product labelling. They are a great marketing tool as they persuade consumers into choosing a certain product from a sea of many similar products. Therefore, it is crucial that the beauty brands use claims that are honest, truthful, sufficiently substantiated and appropriate for cosmetic products. Different countries

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