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Health Canada to update Cosmetic Ingredient Hotlist for AHAs
After six years of consultations and stakeholder engagement, Health Canada is proceeding with updating the Cosmetic Ingredient Hotlist for Alpha-Hydroxy Acids (AHAs). The proposed update aligns with the 2023 consultation proposal, with minor adjustments. AHAs were...
MoCRA REMINDER!
As 2024 has kicked off, the FDA has geared up to enforce its MoCRA requirements for cosmetics. The extended deadline for facilities to submit cosmetic facility registrations and product listings on the FDA Cosmetics Direct portal continues to be July 01, 2024. If your...
The DEL and MDEL renewal season is here!
All DEL and MDEL holders, please be reminded that the deadline to submit your renewal applications this year is Mar. 31, 2024, in order to ensure compliance with regulatory requirements and continue with licensable activities. This process involves an annual fee...
Extended comment period announced for certain Cosmetic Ingredient Hotlist changes
Following the closure of the consultation on proposed updates to the Cosmetic Ingredient Hotlist on October 11, 2022, Health Canada acknowledged and values the feedback received from various stakeholders. In response to inquiries regarding specific ingredients, Health...
FDA unveils its portal for cosmetic regulation – Cosmetics Direct
The FDA has finally launched its much-awaited Cosmetics Direct portal planned under the Modernization of Cosmetics Regulation Act (MoCRA) of 2022, marking a pivotal moment in the regulation of cosmetics within the US. This online platform, seamlessly integrated with...
Summary Reports and Issue-related Analysis Reports
A Periodic Summary Reports is a comprehensive assessment of new information on the benefits and risks of a licensed Class II, III or IV medical device. Summary Reports are required by Health Canada for all medical devices. The reporting timeline for medical device...
Medical Device Incident reporting
Health Canada requires the manufacturer and importer to submit both a preliminary and a final mandatory report constituting the details of any incident relating to the failure of a medical device or any inadequacy in its labelling or in its directions for use...
Foreign Risk Notification (FRN)
Health Canada intends to improve the collection and assessment of new information relevant to the safety of a medical device in certain foreign jurisdictions to help determine an appropriate response in Canada to any risks reported. Per the Foreign Risk Notification...
Health Canada Monograph Revisions Coming Soon!
The Natural Non-Prescription Health Products Directorate (NNHPD) has an important update - they will begin revising all NHP monographs. The primary objective of the monograph revision initiative is to modernize the NHP monographs, ensuring they meet the new NHP...
California Expands Cosmetic Safety Regulations with AB 496
In a move to bolster consumer safety, California is enhancing its regulations governing cosmetics with the introduction of Assembly Bill 496 (AB 496). This law updates the state’s 2020 Toxic-Free Cosmetics Act, which initially banned 24 chemicals from use in personal...
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