Economic interests cloud hazard reductions in the European regulation of substances of very high concern

Abstract

Here we investigate how the conflicts between hazard reduction and economic interests have shaped the regulation of substances of very high concern (SVHCs) under the Authorization program of the European chemical regulation Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH). Since regulation starts with listing SVHCs on the Candidate List, we analyze the relative importance of toxicological properties, economic motivations, and available scientific knowledge on the probability of inclusion on the Candidate List. We find that the most important factor in whether a substance is listed is whether it is being produced in, or imported into, the European Economic Area (EEA), with the regulators less likely to place a substance on the list if it is currently being produced or imported in the EEA. This evidence suggests that regulators have listed chemicals of secondary importance leading to lesser than anticipated hazard reductions, either because production and imports had already ceased before the listing, or because the compound has never been produced or imported in the EEA at all.

Fig. 1. Distribution of CMR and Environmental Score across chemical lists.

Panels (a) and (b) present the distribution of the CMR Score, measuring Carcinogenicity (C), Mutagenicity (M), and Reproductive toxicity (R), and the Environmental Score, measuring environmental hazard, across the five examined chemical lists. Note that some compounds could not be assigned a score as there was no matching entry in the classification and labeling inventory. Sample size (a): European chemical regulation Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH, n = 16,846), Candidate List (CL, n = 247), Authorization List (AL, n = 79), SIN List (SIN, n = 877), PRIO List (PRIO, n = 848). The parallel bars represent the median value while the hinges show the first and third quartiles. The whisker extends 1.5 inter-quartile ranges from the hinge. Outliers are plotted as individual points.

Fig. 2. Marginal contribution of explanatory variables to the odds of inclusion on Candidate List.

The figure presents the point estimates of the odds ratio and the corresponding 95% confidence interval for all parameters included in the logit model where the likelihood of inclusion on the Candidate List is predicted by the toxicological properties of the substances as well as the economic and knowledge parameters. Chemicals listed in the Candidate List are compared to (a) all chemicals registered under the European chemical regulation Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH, n = 15,169), (b) chemicals listed on the SIN list (SIN, n = 874), and (c) chemicals listed on the PRIO list (PRIO, n = 856). Parameters with estimates to the left of the vertical line at 1 will typically be of lower value in the Candidate List as compared to the list with which it is compared, and vice versa.

Fig. 3. Marginal contribution of carcinogenicity, mutagenicity, reproductive toxicity, and environmental properties to the odds of inclusion on the Candidate List.

The figure presents the point estimates of the odds ratio and the corresponding 95% confidence interval for all parameters included in the logit model where we explore in further detail which specific toxicological properties affect the listing on the Candidate List. Chemicals listed in the Candidate List are compared to (a) all chemicals registered under the European chemical regulation Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH, n = 15,169), (b) chemicals listed on the SIN list (SIN, n = 874), and (c) chemicals listed on the PRIO list (PRIO, n = 856). Parameters with estimates to the left of the vertical line at 1 will typically be of lower value in the Candidate List as compared to the list with which it is compared, and vice versa.

Fig. 4. Overlap of substances among the chemical lists.

Venn diagram representing the overlapping of chemical substances included in the European chemical regulation Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH, n = 22,425), Candidate List (CL, n = 303), SIN List (SIN, n = 999), and PRIO List (PRIO, n = 1938).