Probabilistic risk assessment of emerging EU-regulated fragrance allergens in household and personal care products

Abstract

Fragrance allergens in consumer products are an emerging public health concern. In this study, 56 fragrance allergens-including 30 newly designated as mandatory labeling substances under Commission Regulation (EU) 2023/1545 of 26 July 2023 amending Regulation (EC) No. 1223/2009-were quantified for the first time in 267 household and personal care products available in South Korea. Quantification was performed using gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS). Of these allergens, 21 were detected exclusively in 119 kitchen cleaning products such as fruit and vegetable washes, dishwashing detergents, and dishwasher rinse aids, while none were found in disposable wipes. The most frequently detected substances were limonene, linalool, and alpha-terpineol. A tiered risk assessment was conducted based on the quantitative results to identify substances of concern for probabilistic risk assessment. In the conservative Tier 1 assessment, which considered systemic toxicity, skin sensitization, and local respiratory toxicity, five substances-limonene, benzyl alcohol, citral, hexyl cinnamal, and beta-pinene-were flagged as potential concerns and further evaluated in a Tier 2 probabilistic risk assessment using Monte Carlo simulation. The Tier 2 assessment indicated no significant risk for systemic toxicity or skin sensitization, even at the 95th percentile exposure level. Sensitivity analysis identified key contributors to exposure variability: the concentration of the substance in the product, frequency and amount of use, and dilution rate. This study provides critical insight into exposure levels and potential health risks associated with newly regulated fragrance allergens in household and personal care products. The findings emphasize the need to update current safety management standards and demonstrate the value of probabilistic approaches in realistic risk assessments. By evaluating the safety of fragrance allergens in widely used consumer products, this research contributes to the advancement of global health risk management and regulatory science.