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Modernizing Cosmetics Regulation (MoCRA): FDA’s SPL Implementation Guide
On October 13, the US FDA released a Structured Product Labeling (SPL) Implementation Guide with Validation Procedures. This guide encompasses the inclusion of cosmetics product facility registrations and product listings within the SPL framework, offering a significant development in regulatory procedures.
The Guide serves as a resource for the creation of SPL authoring tools. Shortly, as the FDA starts the acceptance of data, users will have the option to transmit SPL-formatted submissions through the FDA’s Electronic Submissions Gateway (ESG) or SPL authoring software, such as Xforms.
This process is in accordance with the requirements stipulated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
Additionally, the electronic submission portal will serve as an authoring tool, offering user-friendly data entry forms, conducting preliminary validations, and subsequently submitting it to the FDA for internal processing.
Future restrictions on Retinol, Kojic Acid, Triclosan and 4-Methylbenzylidene Camphor
The European Commission has notified the WTO of a draft regulation proposing amendments to cosmetics rules regarding the use of certain ingredients. The draft includes a new prohibition for 4-Methylbenzylidene Camphor and restrictions for Vitamin A compounds (Retinol, Retinyl Acetate, and Retinyl Palmitate), Kojic Acid, Daidzein, Genistein, Arbutin, Alpha-Arbutin, Triclosan, and Triclocarban.
The proposed regulation introduces usage restrictions for Vitamin A derivatives, limiting their concentrations in cosmetic products. The restrictions vary depending on the type of product, with body lotions allowed to contain 0.05% Retinol Equivalent (RE), while other leave-on and rinse-off products can have 0.3% RE. The draft also requires mandatory labeling for products containing Vitamin A derivatives to inform consumers about their contribution to daily Vitamin A intake and the potential risks of overexposure.
The draft regulation also addresses ingredients such as Alpha-Arbutin and Arbutin, commonly used as skin-lightening and conditioning agents. Usage limits have been proposed for these ingredients, with different restrictions for face creams and body lotions. Additionally, ingredients like Genistein, Daidzein, and Kojic Acid, which have the potential to act as endocrine disruptors, will be restricted in their usage in cosmetic products. Furthermore, the regulation includes new restrictions for preservatives Triclocarban and Triclosan.
Compliance timelines for these changes vary depending on the ingredient, with the industry being granted a reasonable period to adjust formulations and comply with the new regulations.
The European Commission aims to officially publish the regulation in the fourth quarter of 2023, and compliance deadlines will be set accordingly for each ingredient. The proposed changes seek to ensure the safety of cosmetic products and protect consumers from potential health risks associated with using certain ingredients.
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GREEN AND SUSTAINABILITY CORNER
The European cosmetics industry is facing evolving regulations focused on ingredient safety and consumer health. There is a growing awareness of environmental safety’s importance and its impact on cosmetic products. Recent legislation addresses plastic and microplastic waste reduction. Discussions are underway to conduct a unified assessment considering risks to both human health and the environment. In the context of the green transition, a provisional agreement aims to empower consumers and combat unfair commercial practices, including deceptive “greenwashing” and false claims about product lifespan.
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