EU now allows a new chemical in sunscreens

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.

Just last month, the European Commission adopted amendments to the Regulation (EC) No. 1223/2009 – also known as the Cosmetics Regulation regarding permissible sunscreens. The amendment is the addition of a UV filter that is now approved for use in cosmetic products and sunscreens sold and used in the European Union. The filter is 2,2′-methylene-bis(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethyl-butyl)phenol)/bisoctrizole with an INCI name of Methylene bis-Benzotriazolyl Tetramethylbutylphenol (MBBT), which is also known under its generic name, Bisoctrizole.

MBBT is a broad-spectrum UV absorber, absorbing both UVB and UVA rays. The ingredient is also used due to its stabilizing effect on other UV absorbers. There were initial concerns with this product that caused it to be impermissible in sunscreen products; such as potential bioaccumulation of the ingredient in certain tissues in the body and potential long-term environmental effects to aquatic life. However, it is stated to not pose any risks of adverse effects in humans after topical application on healthy, intact skin.

There were initial concerns with this ingredient; such as potential bioaccumulation of the ingredient in certain tissues in the body and potential long-term environmental effects to aquatic life. However, these appear to have been resolved and it does not pose any risks of adverse effects in humans after topical application on healthy, intact skin.

MBBT is reported by the Official Journal of the European Union to be used in its nano form at a maximum concentration of 10% w/w. Other requirements stated is that the product cannot lead to exposure by inhalation by the consumer. Nano-MBBT is restricted in cosmetic and sunscreen use to equal to or greater than 98% purity with methylene-bis-(6(2H-benzotriazol-2-yl)-4-(isooctyl)phenol) isomer fraction not exceeding 1.5%.

To compare, MBBT has not been reviewed for safety and efficacy by the FDA or Health Canada. As a result, this ingredient is not approved for use in sunscreen products and can only be used as a UV light absorber in cosmetic products.

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

Delsie Braganza

Jennifer Porter, BA Psychology, MBA – President & CEO

EU now allows a new chemical in sunscreens

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