Scientists of the German Federal Institute for Risk Assessment question the scientific basis of the new EU Chemicals Strategy, in particular the hazard-based approach. The eight scientists suggest that the new Chemicals Strategy for Sustainability (CSS) was developed without consultation of risk assessment experts, and regret the absence of expert committees to accompany its implementation.
The scientists suggest that the CSS is not based on scientific evidence, belittles the effectiveness of current EU chemicals legislation and risks interpretational bias (e.g. the CSS does not define key terms used such as “zero-pollution” or “toxic-free”). They question the stated aim of accelerating time needed currently to regulate substances of concern, suggesting that this is due to lack of data and slow administrative procedures, which will not be resolved by the CSS.
They particularly question the validity of the proposed “hazard-based generic approach to risk management” and “Mixture Assessment Factor” (MAF), suggesting that there is today no evidence of increased risk to consumers from combinations of chemicals. Concerning “many years” it currently needed to restrict chemicals after risks are identified, the risk assessment scientists suggest that the “actual scientific risk assessment takes up only a minor fraction” of this time, blaming industry for not providing the full data required by REACH and the European Commission for “time-consuming bureaucratic procedures”.
Lastly, the risk assessment scientists reject the CSS proposed move from risk assessment to generic hazard-based regulation, underlining that this will fail to assess proportionality of measures and will likely result in restrictions of chemicals based on risks related to one specific application or to one particular chemical which are not relevant to other chemicals and applications which will nonetheless be restricted.
“The “EU chemicals strategy for sustainability” questions regulatory toxicology as we know it: is it all rooted in sound scientific evidence?”, M. Herzler and al., German Federal Institute for Risk Assessment (BfR), Berlin, Archives of Toxicology (2021) 95:2589–2601 https://doi.org/10.1007/s00204-021-03091-3