Does REACH provide sufficient information to regulate substances toxic to reproduction?

Hazard classification and risk assessment of substances, is essential to protect workers and consumers from hazardous substances including reproductive toxicants. The ability to classify substances for reproductive toxicity under the current REACH information requirements has been assessed. For low tonnage substances (<10 ton per annum (tpa)) information for classification is insufficient. When only a reproductive screening study is available (10-100 tpa), substances are mostly not classified in Category 1B as developmental and non-potent fertility effects may be missed. The information requirements could be improved by automatic triggering of follow-up studies in case of a Category 2 classification based on a screening study. Additionally, a study could be added to the information requirements for substances produced at 1-10 tpa. Performing a risk assessment is often problematic due to the limited study requirements at low tonnage levels. Only for substances produced at more than 100 tpa, there is a high likelihood to detect reproductive effects and perform accurate risk assessment provided that the extended-one-generation-reproductive-toxicity-study and/or extra cohorts are triggered where required. Regardless of the tonnage level, no specific studies on lactation are required. With this paper we intend to contribute to the discussion on the information requirements for reproductive toxicity in view of the REACH revision.

Approaches to mixture risk assessment of PFASs in the European population based on human hazard and biomonitoring data.

Per- and polyfluoroalkyl substances (PFASs) are a highly persistent, mobile, and bioaccumulative class of chemicals, of which emissions into the environment result in long-lasting contamination with high probability for causing adverse effects to human health and the environment. Within the European Biomonitoring Initiative HBM4EU, samples and data were collected in a harmonized way from human biomonitoring (HBM) studies in Europe to derive current exposure data across a geographic spread. We performed mixture risk assessments based on recent internal exposure data of PFASs in European teenagers generated in the HBM4EU Aligned Studies (dataset with N = 1957, sampling years 2014-2021). Mixture risk assessments were performed based on three hazard-based approaches: the Hazard Index (HI) approach, the sum value approach as used by the European Food Safety Authority (EFSA) and the Relative Potency Factor (RPF) approach. The HI approach resulted in the highest risk estimates, followed by the RPF approach and the sum value approach. The assessments indicate that PFAS exposure may result in a health risk in a considerable fraction of individuals in the HBM4EU teenager study sample, thereby confirming the conclusion drawn in the recent EFSA scientific opinion. This study underlines that HBM data are of added value in assessing the health risks of aggregate and cumulative exposure to PFASs, as such data are able to reflect exposure from different sources and via different routes.