RIFM, European Scientists Work To Iron Out Differences On QRA Methodology

The Research Institute for Fragrance Materials is in talks with industry representatives and European scientific authorities regarding its quantitative risk assessment (QRA) approach to fragrance sensitization, which has been received with varying degrees of enthusiasm.

While some industry members are boycotting the strategy outright, the European Commission's Scientific Committee on Consumer Products has indicated that it cannot support QRA in its current form.

Designed to reduce the incidence of dermal sensitization to fragrance materials, QRA groups consumer products into 11 categories based on the level of exposure a consumer can expect from product use, among other factors.

Concentration limits are assigned to fragrance ingredients for each product category.

"Exposure plays a very big part," RIFM President Ladd Smith, Ph.D., told "The Rose Sheet" Oct. 20. "You know the old adage about table salt - it's an eye irritant ... but if you don't get it in your eye there's no exposure and therefore the risk is low."

Introduced under the 40 Amendment to the International Fragrance Association's Code of Practice, QRA recognizes that a fragrance ingredient - like salt - poses greater risk to the consumer when used in products that offer greater exposure.

"A candle is going to be a different exposure than a feminine hygiene product, [which] is going to be different than a body wash, compared with an underarm deodorant," Smith explained.

By that logic, QRA represents a step forward from the previous system, which recognized just two categories of products - leave-on and wash-off, according to RIFM (¹ (Also see "RIFM Will Work On Filling Ingredient Group Gaps, QRA Implementation In 2007" - HBW Insight, 8 Jan, 2007.), p. 3).

Smith is optimistic that the approach will prove a more effective way to protect consumers, with fewer clinical reports of allergy to fragrance ingredients.

Over the summer, however, the European Commission's scientific advisory panel, SCCP, issued an opinion in which it withheld an endorsement of QRA, noting that the methodology could be applicable down the road if certain concerns are resolved (² (Also see "SCCP Uncertain About Propyl & Butyl Parabens, Has Issues With IFRA’s QRA" - HBW Insight, 28 Jul, 2008.), p. 5).

According to Smith, those concerns are largely related to the question of induction versus elicitation - i.e., whether fragrance material limits should be established with the goal of preventing sensitization or to ensure that an already sensitized individual does not suffer an allergic reaction.

SCCP, he said, is more focused on the latter. "They're looking at it from that secondary prevention/clinical perspective, as opposed to perhaps the research perspective ... [which] we think is more protective because we stop the induction. We want to get it before it prompts the immune system to respond," Smith explained.

He is confident that with ongoing discussion RIFM and SCCP will be able to come to an understanding.

The International Fragrance Association and the European Flavor and Fragrance Association are also involved in those talks, Smith said.

Some industry members are concerned that QRA will require companies to undertake sweeping reformulations. Natural fragrance watchdog Cropwatch has been particularly resistant, claiming the "mountains of paperwork" will bury small manufacturers (³ , p. 3).

In August 2007, Cropwatch co-founder Tony Burfield reported that the organization's petition against IFRA's 40 Amendment had collected more than 900 signatures.

RIFM Database Grows; No Non-Member Use

The Research Institute for Fragrance Materials is "on track" to publish a safety summary for every fragrance ingredient group within a decade, with 15 to 20 groups expected to be completed by year-end, according to Smith.

Those 15 to 20 groups encompass roughly 300 "priority" fragrance materials, he said.

Most recently RIFM published group summaries for related esters and alcohols of cinnamic acid and cinnamic alcohol, ionones and salicylates.

In January the institute opened its fragrance and flavor database to non-members (⁴ (Also see "RIFM To Open Fragrances And Flavors Database To Non-Members In New Year" - HBW Insight, 7 Jan, 2008.), p. 3).

In addition to RIFM-generated group summaries, the database contains studies sponsored by member companies, government reports and current literature, amounting to "the most comprehensive, worldwide source of toxicology data, literature and general information on fragrance and flavor raw materials," RIFM says.

The institute has noted that such a wealth of information could help guide companies in their efforts to comply with European Registration, Evaluation, Authorization & Restriction of Chemicals law.

REACH requires manufacturers to provide the European Chemicals Agency in Helsinki, Finland with safety dossiers for chemicals they use.

"Unfortunately we haven't had any takers yet," Smith said, noting that parties that have shown interest ultimately declined, claiming to have found the information they require elsewhere.

"What we have tried to understand is exactly what that [information] is and where, because to my knowledge the information that we have doesn't really exist somewhere else," he said.

RIFM currently is reexamining its pricing for database access; going into 2008, RIFM Technical Manager Christen Sachse-Vasquez told "The Rose Sheet" that non-members would be charged $19,500 for one user and $34,500 for two to five users.

- Ryan Nelson ([email protected])