The International Fragrance Association (IFRA) have recently released the 49th amendment to their Code of Practice, the largest update in years. IFRA has been promoting the safety of fragrances in products since 1973. The self-regulating body has been promoting safety through prohibition and concentration restrictions of fragrance materials based on Quantitative Risk Assessments (QRA), an exposure based assessment. The most recent update to the IFRA Code of Practice included 25 new standards, bringing the number of substances up to 214. As well, the recent update introduces a 12th category to further clarify regulations of specific fragrance ingredients. However, the largest update was to QRA, introducing Quantitative Risk Assessment 2 (QRA2).
Similar to QRA, QRA2 was revised through the input of dermatologists, academics, industry personnel, and stakeholders. QRA2 is a revised methodology for quantitative risk, focusing more on aggregated exposure than its predecessor. By focusing more on aggregated exposure, the exploration of the same fragrance ingredient contained in different products is investigated using databases on real-life product use and habits in a statistical model. This new methodology provides a more realistic look at fragrance ingredients and skin sensitization.
These large changes to the IFRA Code of Practice were necessary for multiple reasons. First, the amendments allowed for harmonization of skin sensitization and systemic toxicity endpoints. Secondly, while the changes maintain the core values of human health and maintaining the environment, the amendments allow the consideration of computation toxicology tests and alternatives to animal testing, wherever possible. Global fragrance manufacturers will need to comply with these changes by February 10 2021, for new products, and by February 10 2022 for pre-existing products. This time frame allows corporations an opportunity to reformulate if necessary. IFRA plans on holding training sessions and webinars for members, to aid in a smooth transition. As well, IFRA will provide a list of service providers who can help with testing and reformulation. For more information on this subject please visit the websites of CosmeticDesign Europe, ecomundo, UL, and the IFRA.
For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA