RIFM is evolving its safety evaluation process to more rapidly incorporate advances in in vitro and in silico methodologies. The focus of the evaluation is now on the individual fragrance material. This will allow RIFM to take of advantage of advances in the science of safety evaluations, as well as meet the increasingly stringent requirements from regulatory bodies and the increased expectations of fragrance users.
Exposure data are essential for the completion of a safety assessment for all human health endpoints. RIFM, with member company representatives and Creme Global (a well-established partner to Industry in modeling exposure for cosmetics and foods, and their methodology is used and accepted by regulators), developed a probabilistic aggregate exposure model to calculate total systemic exposure, with distributions used to model various parameters. The new model will enable the measurement of real life consumer exposure to a fragrance material.
RIFM will be requesting concentration data for most of the fragrance materials in use today and will use the concentration data to calculate the total systemic exposure needed for a safety assessment. The concentration data will remain confidential. This Concentration Survey is RIFM's first request for data on 60 fragrance ingredients. The link below will provide information on registration for transferring survey data and on completing the survey:
Once registration is complete, Creme Global will provide login details and the responder will be able to download the Excel spreadsheet and upload responses for each fragrance ingredient. Each organization has a separate upload site. Please complete and return this survey by May 31, 2013.
A RIFM Webinar will be held on Wednesday May 8, 2013 to explain in detail how this survey should be completed. More information on the Webinar is available in the Member area of the RIFM website.
RIFM will issue a new survey each month. The concentration data will be entered into the model but the sources of the data will not be made available. The information must be provided from fragrance compounders (companies that blend fragrance ingredients) for marketed fragrance mixtures only. Please do not enter exposures that are not currently in use.
RIFM will follow due diligence to obtain exposure information. Materials for which usage concentration data are not provided will be eliminated from the RIFM evaluation process. At that time, RIFM will inform IFRA that due to lack of data a safety evaluation cannot be completed. The material will then be reviewed by IFRA for possible risk management actions which may include removal from the IFRA Transparency List and/or a ban due to insufficient data.
For more information, please contact Dr. Anne Marie Api, firstname.lastname@example.org.