Risk management of skin sensitisers: A commentary

• Published in: Regulatory toxicology and pharmacology 2023-05, Vol.140, p.105384-105384, Article 105384
• Main Author: Basketter, David A.
• Format: Article
• Language: English
• Subjects: Allergens; Dermatitis, Allergic Contact - diagnosis; Dermatitis, Allergic Contact - etiology; Dermatitis, Allergic Contact - prevention & control; Humans; Patch Tests; Perfume - adverse effects; Risk assessmen; Risk Assessment - methods; Risk management; Skin; Skin sensitisation
• ISSN: 0273-2300; 1096-0295
• DOI: 10.1016/j.yrtph.2023.105384

Historically, allergic contact dermatitis (ACD) to chemicals encouraged hazard identification improvements, more sophisticated risk assessment and implementation of regulatory strategies, including banning of specific sensitising substances. The validation process applied to hazard identification methods demonstrates their accuracy; their use to characterise sensitiser potency facilitates quantitative and transparent risk assessment. Diagnostic patch testing at dermatology clinics worldwide delivers feedback showing where risk assessment/management has been insufficient or did not target the exposure of concern, thereby facilitating improvements. When urgent action to protect human health was required, regulations limited/banned, specific skin sensitisers. This can be seen in practice with the fragrance industry, a known source of ACD, thus requiring risk management, usually restrictions to limit allergy induction, and very rarely specific bans on ingredients. Experience and development of more sophisticated tools, e.g. to assess aggregate exposure from multitude of consumer product types, has led to repeated adaptation of risk assessment and promulgation of updated fragrance use limits. Although targeted control may not always lead to rapid change in the overall clinical picture, it is preferable to a blanket undifferentiated regulatory control of all sensitisers, resulting in unwarranted restrictions for many uses of no health concern, with consequent substantial socio-economic impacts. •Skin sensitisers are regulated largely on the basis of intrinsic hazard.•Evidence that this has been beneficial for human health is absent.•In contrast risk-based regulation of specific skin sensitisers has a positive impact.•Any future legislation therefore should be specific and evidence-based, not generic.