Regulatory news and insights
Updates on EU, UK and international cosmetics regulations, explained by our regulatory team.
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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The World of Sunscreen: A Guide to Global Regulatory Landscapes
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
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…
Read articleMajor 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…
Read articleFDA 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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New standards for BHT and kojic acid in cosmetics in the UK
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…
Read articleMoCRA – 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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EU REACH microplastics restriction
On 27 September 2023, the EU Commission published the EU REACH microplastics restriction. This means that the provisions will officially enter into force on 17 October 2023, which is the date when the transition periods will also start. The EU Commission took a big step towards fighting microplastics pollution by adopting new measures under EU…
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EU’s plan to ban greenwashing
The European Parliament and Council have come to a provisional agreement on a set of new rules that target misleading marketing claims while aiming to provide consumers with more accurate product information. This agreement involves an update to the existing list of banned commercial practices in the EU and includes additional provisions to address deceptive…
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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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Fragrance allergens update
On July 27, 2023, the EU Commission published Regulation (EU) 2023/1545, which updates labelling requirements for fragrance allergens in cosmetic products. It provides an expanded list of allergens that must be disclosed on cosmetic product labels. The fragrance allergens listed in entries 45 and 67—92 of Annex III to Regulation (EC) No 1223/2009 remain relevant,…
Read articleMicroplastics in the Cosmetic Industry: Regulations and Latest Developments
Introduction Microplastics have become a significant environmental concern due to their widespread presence in various ecosystems, including oceans, rivers, and even the atmosphere. The cosmetic industry has been under scrutiny for its contribution to microplastic pollution. In this blog, we will explore the issue of microplastics in the cosmetic industry, the existing regulations, and provide…
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