Regulatory Sponsored by
Axel Schnuch, University of Goettingen
The fragrance industry has long faced pressure to meet international standards on product safety. Accustomed to self-regulation, it continually works to refine its regulatory framework to make it more robust and effective. Yet the industry still faces continual public health pressure from regulators and other stakeholders seeking to ensure that its products do not cause allergic reactions.
The International Fragrance Association (IFRA; ifraorg.org) recently held a workshop to discuss these issues. Presentations were given about current scientific studies on allergic reactions and the regulatory landscape, specifically in the European Union. While the problems the industry faces are similar to other highly regulated businesses due to public health concerns, the speakers concluded that they may not be as severe as some stakeholders assume .
According to Axel Schnuch of the University of Goettingen, sensitization to important fragrance ingredients has decreased considerably, and for some weak allergens such as limonene, 10,000 patients would need to be tested to identify one case. When it comes to the 26 fragrance ingredients to be labelled according to current European regulation, there is a big difference with regard to sensitization and clinical cases observed. In a study carried out between January 2003 and December 2004, 26 fragrances were patch tested using a standard series on a total of 21,325 patients; the number of patients tested with each of the fragrance ingredients ranged from 1,658 to 4,238. The study found that substances with higher sensitization frequencies were characterized by a considerable number of reactions. However, substances with low sensitization frequencies were characterized by a high number of doubtful reactions and a low number of stronger reactions. Schnuch and his team concluded, “There are obviously fragrance ingredients among the 26 which are, with regard to contact allergy, of great, others of minor, and some of no importance at all.” Professor Schnuch further pointed out the importance of continuous monitoring of clinical epidemiology and linking the results with the risk management measures of regulators and the industry.
Another study led by Thomas Diepgen of the University of Heidelberg, the EDEN Epidemiological Study (eden.dermis.net), is being carried out at the moment. The pilot project started in 2005, and the full study is planned to be completed this year. The professor outlined the need for a further study as current studies have the following problems:
The EDEN group has several things that it wants to determine: how many people have, or have had, a skin problem due to a product; how severe is this problem; is there an irritation versus sensitization issue; what are the allergens; are there country specific differences (exposure); what are the sensitization rates in healthy subjects and are there any age, gender or ethnicity cofactors?