▪︎ Restrictions, REACH
Legal Challenge to the SVHC Assessment of n-Hexane: A Precedent for REACH Enforcement
By adding n-hexane to the Candidate List of Substances of Very High Concern (SVHC), ECHA has broken new regulatory ground. This is the first time a substance has been classified as an SVHC based on its specific target organ toxicity (STOT). ExxonMobil and Shell have now filed a lawsuit challenging this decision. The case could have far-reaching consequences for the interpretation of the REACH Regulation and the future identification of substances of very high concern.
A Novel SVHC Evaluation Under REACH
n-Hexane is an organic solvent that occurs naturally in crude oil and is obtained through refining processes. It is widely used in industrial production, including the extraction of vegetable oils, laboratory and manufacturing operations, and products such as degreasers, adhesives, and coatings. In February, ECHA added the substance to the REACH Candidate List. The decision was based not on carcinogenic, mutagenic, or reproductive toxicity properties, but rather on its assessment as a substance presenting an Equivalent Level of Concern (ELoC).
The evaluation is based on the harmonized CLP classification of n-hexane as STOT RE Category 1. The decisive factor is its neurotoxic effects, which are caused by the metabolite 2,5-hexanedione. Reported health effects range from headaches, dizziness, and sensory disturbances to muscle weakness and visual impairment. According to Slovenia, which submitted the SVHC proposal, severe nerve damage in particular may have long-term consequences for affected individuals’ quality of life.
Industry Raises Legal and Scientific Concerns
The plaintiffs argue that ECHA has exceeded its authority under REACH. In the action filed before the General Court of the European Union, they allege, among other things, manifest errors of assessment, disproportionate regulation despite existing risk management measures, and violations of the principle of legal certainty. Particular emphasis is placed on the absence of comparable precedents for an SVHC identification based on a STOT endpoint.
Potential Implications for European Chemicals Regulation
Despite these objections, ECHA’s Member State Committee (MSC) unanimously endorsed the proposed classification. In doing so, it effectively opened a new field of application for Article 57(f) of the REACH Regulation. This provision allows substances to be identified as SVHCs where scientific evidence indicates serious effects on human health or the environment that give rise to a level of concern equivalent to that associated with traditional CMR substances or highly persistent chemicals.
As recently as July of last year, a legal challenge against the inclusion of melamine on the REACH Candidate List was unsuccessful. At that time, however, the issue was whether an inherent property is required for a substance to be classified as an SVHC.
The pending court proceedings are therefore likely to have significance far beyond the specific assessment of n-hexane. If the court upholds ECHA’s position, the Agency could gain greater flexibility in identifying additional substances with novel hazard profiles as SVHC. Conversely, a ruling in favour of the plaintiffs could raise the threshold for future SVHC identifications and redefine the scope of the ELoC concept under REACH. For companies in the chemical, oil, and manufacturing sectors, the case is therefore of considerable regulatory importance.
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