Evaluation Process

The primary goal of a safety evaluation by the Research Institute for Fragrance Materials (RIFM) Expert Panel (REXPAN) is to ensure the safe use of fragrance materials. Maintaining a rigorous and transparent safety evaluation process ensures that the scientific opinions of REXPAN will continue to strengthen the credibility of the International Fragrance Association (IFRA) standards, as well as the credibility of the IFRA member associations, including FMA. The transparency of the process is primarily through the publication of REXPAN evaluation conclusions and the underlying science in the peer-reviewed literature.

The process of a REXPAN safety evaluation generally occurs in the following sequence:

First, an evaluation normally begins as the result of a request from IFRA, official agencies or other stakeholders, or from a scientific query by RIFM or REXPAN itself. The specific materials to be evaluated for an acceptable level of exposure are identified, and the relevant endpoints are chosen. Because the fragrance industry uses many different materials, RIFM is tasked with setting priorities for evaluation, in consultation with IFRA, its member associations, and other stakeholders.

Once the materials are identified, RIFM compiles the scientific data necessary for a REXPAN evaluation. This will initially involve searching the scientific literature, including the RIFM database, for relevant data. Once the currently available safety data has been found, remaining gaps in the scientific knowledge will be filled through the RIFM research and testing program. A critical component of any safety evaluation for each material is an assessment of the potential for human exposure. The exposure is estimated from production volume, application, and use data, each of which is supplied by the IFRA Scientific Committee (SC).

Once data collection is complete, RIFM assembles a draft “fragrance material dossier” for review by REXPAN. During this review, REXPAN may request the assistance of external experts with specialties in critical areas of the evaluation (e.g., dermatology, genotoxicity, chemistry, environmental fate). After this review, additional data requests by REXPAN are fulfilled by RIFM, in consultation with the IFRA SC.

Once the REXPAN evaluation is complete, the conclusions are prepared in a final dossier that describes the critical effects assessed and the final conclusions from the evaluation. This evaluation is prepared for publication in a peer-reviewed journal. Additionally, the full evaluation is sent by RIFM to IFRA. If REXPAN recommends a change in the current standard, the IFRA secretariat is tasked with drafting the new IFRA standard. This is done in consultation with the IFRA SC, IFRA member associations (including FMA), and the client industry. Ultimately, REXPAN approves the final wording of any new IFRA standard, and after approval IFRA disseminates the standard to its members throughout the world.