Risk Assessment

 Risk Assessment Approach

Over 2600 ingredients are used in the manufacture of fragrances. The majority of these ingredients have been used for many decades. Despite this long history of use, all of these ingredients need continued monitoring to ensure each ingredient meets acceptable Safety Standards.

The fragrance industry has maintained a system of safety assurance for more than 30 years. The resulting IFRA Standards are based on:

- the scientific assessment of potential hazards (extensive set of toxicological data)

- comprehensive information on use of and exposure to fragrance materials by RIFM, and 

- subsequent evaluation and conclusions (dermal effects, systemic toxicity and environmental consequences) by the RIFM Expert Panel.

The IFRA/RIFM alliance allows for a close coordination of information and action to ensure the safe use of fragrance materials: IFRA uses conclusions from the Risk Assessment as the basis for the issuing of Standards, thereby ensuring proper Risk Management.

Four scientific papers have been published which describe the processes used by IFRA and RIFM for the evaluation of human health and environmental safety for fragrance materials. These papers establish the prioritization framework for both human health and environmental risks of the more than 2600 fragrance materials. These papers also describe the means for estimations of exposure through consumer use and the review process by the Expert Panel. Relevant prioritization is needed as many of the 2600 fragrance materials have low levels of use per year. This method also allows for proper management of time and resources.

Priority is given to materials with high volumes of use and/or greater potential risk. These frameworks are dependent upon volume of use, product content, predicted or measured toxicological endpoints, and predicted or measured environmental risk for each material for risk assessment purposes. A simplified representation of the framework for prioritizing fragrance ingredients for human health evaluation is included below. A score system ranging from 0 to 48 is generated for each material based on its worldwide use (max 16 points), content in goods (max 16 points) and from structural alerts (max 12 points). Greater scores increase the priority.

(^a used when data is unknown, Table summarized from Ford, RA et al. (2002))

The risk assessment process include studies on skin irritation, sensitization, phototoxicity (if the ingredient absorbs in the UV range), environmental basic data sets (measured or calculated), and repeated dose toxicity, reproduction and developmental testing. Furthermore, respiratory effects are examined through the RIFM respiratory sciences program.

For dermal sensitizers, IFRA has implemented a new approach to risk assessment: the Quantitative Risk Assessment (QRA). The QRA methodology for dermal sensitization for fragrance ingredients identifies concentration limits for a number of product types. Product types are grouped into product categories according to similar safety assessment factors and exposure, which lead to similar acceptable use levels of a fragrance ingredient.  The first QRA Standards were published in May 2006 as part of the 40th Amendment to the IFRA Code of Practice.