MoCRA

February regulatory roundup

EU regulatory news Urgent Update on Benzotriazole: Regulatory Action Proposed Germany’s evaluation of Benzotriazole under the CoRAP has revealed severe environmental hazards, including its status as an endocrine disruptor and its persistence and mobility. These findings have led to recommendations for: This evaluation highlights the necessity for swift regulatory measures to address the environmental impact […]

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December regulatory roundup

EU regulatory news ECHA’s Draft CoRAP 2024-2026 Includes 28 Substances for Evaluation, Focusing on Consumer Safety The European Chemicals Agency (ECHA) has revealed its draft for the Community Rolling Action Plan (CoRAP) for 2024-2026, listing 28 substances for evaluation. This plan includes 11 new substances and assesses cosmetic ingredients for potential health risks. Critical evaluations

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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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November regulatory roundup

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

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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CE.way Regulatory Consultants Expands to Arizona to Navigate New US Cosmetics Regulation – MoCRA

In an exciting move to broaden its international presence and meet the growing demand for regulatory consulting services in the cosmetics industry, CE.way Regulatory Consultants, a renowned regulatory compliance firm, has established a new subsidiary in the United States, specifically in the state of Arizona. This strategic expansion aims to position CE.way as a key

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