Amendments to Health Canada’s Cosmetic Ingredient Hotlist

Delsie Braganza

Delsie joined the Focal Point Research team in 2011 and has been an invaluable asset for our clients. With her strong regulatory and quality assurance background, she is able to help clients understand the Canadian and US requirements, set targets to achieve compliance, and attain their goals to get products to market.

Delsie is able to audit facilities, set up and maintain GMP compliant facilities, develop strong quality management systems, and co-ordinate successful Health Canada inspections. In addition to this, Delsie oversees all regulatory compliance reviews and submissions made to Health Canada and the US FDA.

Delsie obtained an Honours Bachelor of Science (Hons. B. Sc.) in Pharmaceutical Chemistry from the University of Toronto, Post-Graduate Certificate in Pharmaceutical Regulatory Affairs and Quality Operations (RAQ) from Seneca College and Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society (RAPS).

When she’s not learning something new, Delsie loves spending time with family, going on road trips or long walks, and swimming.

Jennifer Porter, BA Psychology, MBA – President & CEO

Having started at Focal Point Research in 2011, Jenn has been fully engaged in the company and since day one, has leveraged her MBA and interest in the regulated products industries to grow her passion for the business and services offered.

Jenn has excelled at building on initial conversations with a variety of companies from all industries seeking regulatory and quality assurance services. She has developed strong relationships with each client, offering each one a unique opportunity to have the Focal Point Research team help them develop successful strategies and bring products to market, while ensuring their compliance needs are being fulfilled.

Jenn has not only been a leader internally, but a key contact for all clients and in 2021, Jenn was the obvious choice to lead Focal Point Research into the future as the successor to company founder, Rob Fichtner.

Jennifer balances her career by honouring her wanderlust, spending her leisure time golfing, and enjoying the outdoors with her loving dog.

Health Canada has recently updated their Cosmetic Ingredient Hotlist as of June 2018. This updated Hotlist has added pigment red 4, also known as Red 36 or CI 12085, to its list of restricted substances with a maximum concentration of 3% permitted in cosmetic products. This addition was due to potential health concerns identified by the Chemicals Management Plan (CMP).

Additional amendments to the Hotlist includes changes to the preservative methylisothiazolinone (MI). MI is a restricted substance in the Hotlist and amendments have been made to add a new condition for the substance as prohibited in leave-on cosmetics products, as well as reduce the maximum concentration allowed in rinse-off products to 0.0015%. This is due to risks of sensitization. For products containing both MI and a mixture of Methylisothiazolinone and Methylchloroisothiazolinone (MI/MCI), the total concentration of MI/MCI and MI combined shall not exceed 0.0015%. This regulation brings Canada in line with Europe. Chloramine T has been amended as well, to add “related compounds”. These related compounds have been known to convert into Chloramine T when mixed into a solution. Lastly, Oleandrin has been removed from the Hotlist and as been moved under an existing entry, “Nerium oleander, its extracts and glycosides”. This is because all parts of the Nerium oleander plant are toxic.

The Cosmetic Ingredient Hotlist is a tool created by Health Canada for manufacturers and distributers of cosmetics to ensure that their products are safe for use and not contain substances that may be prohibited or restricted. The Hotlist is a science-based document and is reviewed and updated periodically or when new scientific data becomes available.

Although there is no compliance enforcement action plan imminent, manufacturers and distributers of cosmetics containing these amended substances are suggested to develop and implement a compliance action plan. This includes undergoing a review and safety assessment to determine any potential risks. Depending on the outcomes, appropriate actions should be taken, including monitoring, reformulation or removal of the product from the market.

For more information, please do not hesitate to contact Focal Point Research Inc. We are leading Canadian regulatory and Health Canada consultants for Cosmetics, and other personal care products.

Delsie Braganza

Jennifer Porter, BA Psychology, MBA – President & CEO

Amendments to Health Canada’s Cosmetic Ingredient Hotlist

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