How does a substance become an SVHC?

— LEGAL FRAMEWORK

As known, one of the cornerstones of REACH is the Authorisation List and the related Candidate List, which contains Substances of Very High Concern (SVHCs). But what determines whether a substance qualifies as an SVHC? To be identified as an SVHC, a substance must meet at least one of the following criteria:

a) Carcinogenity

b) Germ Cell Mutagenicity

The substance is of Carcinogenic 1A or 1B category hazard class according to the relevant regulations.

it has been classified as Germ-Cell Mutagenic category 1A or 1B based on scientific evidence.

c) Reproductive Toxicity

d) PBT Properties

It is classified as Reprotoxic category 1A or 1B.

The substance has been shown to have persistent, bioaccumulative and toxic (PBT) properties based on environmental assessment.

e) vPvB Properties

f) Equivalent Concern

The substance has been classified as very persistent and very bioaccumulative (vPvB) based on environmental studies.

The so-called substances of equivalent concern – for which it can be determined that they are likely to have a serious impact on human health and the environment that is of equal concern to the substances listed in points a) to e).

The n-hexane case

STOT RE 1 classification

Repeated-exposure target organ toxicity affecting the central nervous system as a reason for inclusion on the Candidate List.

Of the categories listed above, points (a) to (e) provide a relatively clear framework for identifying SVHCs. Point (f), however, can involve a greater degree of scientific and regulatory judgement, despite the existence of specific criteria that must be fulfilled. This has, on occasion, been a source of controversy.

February 2026

SVHC classification date

A notable example is the case of n-hexane, which was identified as an SVHC in February 2026 on the basis of its specific target organ toxicity following repeated or prolonged exposure (STOT RE 1), affecting the central nervous system, as demonstrated by a study accepted by the Agency.

The assessment concluded that n-hexane gives rise to a level of concern equivalent to that associated with substances falling under points (a) to (e). However, several stakeholders from the oil industry have challenged the decision before the courts [1], arguing that the inclusion of n-hexane on the Candidate List is disproportionate.

Forrás:
[1] https://eur-lex.europa.eu/eli/C/2026/3073/oj?eliuri=eli%3AC%3A2026%3A3073%3Aoj&locale=en