QRA - Quantative Risk Assessment

Based on RIFM's Expert Panel's recommendation, IFRA and RIFM have formally agreed to adopt the Quantitative Risk Assessment (QRA) approach, refined for fragrance ingredients identified as contact allergens, as the core strategy for primary prevention of dermal sensitization to these materials in consumer products.

The QRA methodology for dermal sensitization for fragrance ingredients identifies concentration limits for various of product types. These 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. As such, the QRA is a step forward on existing risk management strategies, under which each specific fragrance ingredient identified as an allergen is limited to the same concentration across all skin-contact product types.

Skin exposure in terms of dose per unit area is highly important for the quantitative risk assessment methodology. Some of the chemicals in common use today may have the potential to cause dermal sensitization. However, the fact that a chemical is a dermal sensitizer does not mean it cannot be formulated into consumer products at safe levels. This is also the case for fragrance ingredients.

Based on the chemical, cellular and molecular understanding of dermal sensitization, it is possible to conduct an exposure-based QRA to determine safe levels of fragrance ingredients in different consumer product types. The implementation of the Dermal Sensitization QRA approach started in May 2006, with the publication of a first set of QRA Standards as part of the 40th Amendment.

Quantitative Risk Assessment (QRA) Data From for Categorization of Product Types

The introduction of the QRA as the basis for IFRA Standards on ingredients exhibiting a potential for dermal sensitisation led to the Standards having individual restrictions for 11 product categories. The categories were achieved by grouping consumer product types according to key parameters identified within the QRA approach. These parameters are Sensitization Assessment Factors (SAFs) and consumer product exposure, which when combined, lead to similar acceptable use levels of a fragrance ingredient. In cases, where a product is not currently categorized and where the likely consumer product exposure is clearly different or where the matrix may indicate a higher degree of potential penetration or irritation, then it is incumbent on the fragrance supplier to contact the IFRA secretariat for advice on appropriate product categorization. This would lead to a modification of the IFRA/RIFM Information Booklet and the IFRA membership and stakeholders would be adequately informed about the change(s).

There is critical information that is necessary to classify new product applications, so far not included in the system, or to reclassify existing entries. RIFM and IFRA have developed a form to help those who would like to have a new product type classified.

Information should either be sent to Anne Marie Api at RIFM or Matthias Vey at IFRA. Requests for (re)-categorization should reach either IFRA or RIFM before the end of October each year so they can be included in the update of the QRA-Information booklet that will be issued with the next IFRA Amendment the following spring.

In the absence of sufficient information, product types will be categorized using a conservative approach.