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Cosmetics Direct FDA Portal for Cosmetic Product Listing is Live

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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

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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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Sunscreen regulations

The World of Sunscreen: A Guide to Global Regulatory Landscapes

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Sunscreen, a crucial component of skincare routines, is poised to continue as a prominent trend in the next decade. This surge in popularity is fueled by increasing awareness of skin health and the risks associated with UV radiation. The article explores the intricate and diverse regulations governing sunscreens worldwide, which are vital for cosmetic companies

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November regulatory roundup

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EU regulatory news SCCS Final Opinion: Butylparaben Deemed Safe as Cosmetic Preservative at Low Concentrations: The SCCS’s “SCCS/1651/23 Final Opinion” states that Butylparaben is safe for adults in cosmetics at up to 0.14% concentration but suggests more data is needed for children’s safety. The evaluation focuses solely on consumer safety, not environmental factors. SCCS’s Final

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

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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

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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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New standards for BHT and kojic acid in cosmetics in the UK

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The UK cosmetics industry is about to undergo significant change, as the Scientific Advisory Group on the Chemical Safety of Consumer Products (SAG-CS) has published a series of key recommendations. Previously unregulated, butylated hydroxytoluene (BHT) and kojic acid have been scrutinized for their potential endocrine-disrupting effects, resulting in extensive revisions. The new framework for maximum

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MoCRA – which businesses qualify for exemption?

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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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