Substances of Equivalent Level of Concern

This group of SVHCs is a category introduced as a safety net in REACH authorisation in order to include very hazardous substances of equivalent level of concern to the other categories, where there is scientific evidence for probable serious effects (REACH article 57f).

Substances with endocrine-disrupting effects are mentioned as one example of a group of substances causing such equivalent level of concern. Identification takes place on a case-by-case basis.

In short, identifying equivalent level of concern substances as SVHCs and adding them to the SIN List has been a three-stage process.

  1. Selection and filtering of substances relevant for REACH
  2. Literature research on selected substances
  3. Evaluation against REACH criteria for SVHCs and justification for inclusion

 

Evaluation of ELoC chemicals in 2008

For the first version of the SIN List, substances were identified as belonging to this category based on a combination of different hazardous properties.

First, a rough list was compiled of substances from many different records and lists of recognised hazardous chemicals. Examples of such lists are the OSPAR list of chemicals of possible concern & priority action, the EU Water Framework Directive, the Swedish Chemicals Agency’s (KEMI) PRIO list, as well as lists by the US and Canadian Environmental Protection Agencies. Further, substances listed on collaborating companies’ grey and black lists were included.

The resulting rough list contained altogether approximately 4,000 substances with different levels of concern. The Swedish Chemicals Agency (KemI) was then asked to search its “Products Register” for the occurrence of these 4,000 substances in chemical products and preparations available to consumers. KemI responded with a refined list of approximately 250 of the original 4,000 substances. Information from the European Chemicals Bureau was then used to obtain information on high-production-volume chemicals. This refined the list further to roughly 150 substances.

From this point on, substances were manually selected and screened, bringing the final number of potential equivalent level of concern substances to be evaluated and assessed to 60.

After this, toxicologists were assigned to conduct an exhaustive literature search for each of the 60 substances. They were also asked to conduct an in-depth assessment on each substance to determine whether these substances would qualify as Substances of Very High Concern under REACH. The toxicologists were instructed to use the official REACH guidance document on how to identify equivalent level of concern SVHCs and prepare an Annex XV dossier as stated in the “Guidance for the preparation of an Annex XV dossier on the identification of substances of very high concern” from June 2007. This was then used as a basis for the SVHC assessment.

The background data used was primarily published scientific literature but also data from existing risk assessments and EU studies of these substances, when available. The assessment looked at the combined properties of these substances, meaning that all known properties and gathered data were considered.

The dataset included CMR and endocrine-disrupting properties as well as tendencies to persist in nature and/or bio-accumulate and whether the substances had been detected in humans and biota. This combination of different hazards, which individually might not have fulfilled the criteria for SVHC, when assessed together built up a strong case for an equivalent level of concern substance.

After the toxicologists’ assessments, the background data and conclusions were subject to further scrutiny by additional scientists. Guided by these scientific evaluations, ChemSec decided to add 30 substances for which the evidence was sufficient to demonstrate probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other SVHCs.