On 4 August, the deadline passed for EU brands to notify Brussels about two new substances of very high concern: one of them, n-Hexane, is the first substance the EU has ever added to that list for nerve damage, not the cancer or fertility risk the list was built around

A catch-all clause, used for a new kind of hazard

REACH Article 57 sets five gateways onto the Candidate List: carcinogenic, mutagenic or toxic for reproduction (points a to c), persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative (points d and e), and a residual gateway, point f, for substances that fail the PBT or vPvB tests but present an 'equivalent level of concern'. Point f has, in practice, almost always been used for endocrine disruptors. Slovenia submitted its proposal to identify n-Hexane as an SVHC on 18 February 2025, arguing that its harmonised classification for specific target organ toxicity after repeated exposure, STOT RE 1, causing nerve damage on prolonged contact, met that equivalent-concern bar even though nerve damage is neither a PBT property nor an endocrine one. ECHA's Member State Committee agreed at its December 2025 meeting, and the substance, alongside Bisphenol AF and its salts, added under the more conventional reproductive-toxicity gateway, point c, entered the Candidate List on 4 February 2026.

The numbers behind 4 August

One number is the size of the list a substance just joined. One is the concentration threshold that decides whether a component triggers the notification duty. The third is how long brands had between the listing and the deadline that just passed.

The real subject: a hole in the screening net, not a bigger list

A brand that screens formulations and bills of materials against the Candidate List by checking for known carcinogens, mutagens, reproductive toxicants and PBT substances, the gateways that produced every SVHC before n-Hexane, has a screening net with a hole exactly where n-Hexane got through. The equivalent-level-of-concern clause existed in REACH's original 2006 text, but ECHA had used it almost exclusively for endocrine disruptors until Slovenia's proposal. Nothing in the text restricts it to endocrine or PBT-adjacent hazards: any well-evidenced 'probable serious effect' can qualify, once a member state makes the case and the Member State Committee agrees. Neurotoxicity is the hazard class that just proved it can clear that bar. A substance-screening process that treats point f as an endocrine-only backstop will not flag the next STOT-based candidate before it lands on the list, only after, which is precisely the position most suppliers of n-Hexane, a common solvent in extraction, adhesives and coatings, were in on 4 February.

Why it matters for brands

For any retail, consumer-goods or luxury brand placing articles on the EU market, directly or through suppliers, three things follow from 4 August. First, re-run bill-of-materials screening for n-Hexane and Bisphenol AF specifically: n-Hexane turns up as a solvent in adhesives, coatings, rubber processing and vegetable-oil extraction, and Bisphenol AF as a cross-linking agent in specialty polymers and rubber, both common inputs in footwear, accessories and hardware components that many catalogues would not have flagged before February. Second, track the two duties separately: the Article 33 obligation to inform customers a component contains an SVHC applied from 4 February, months before the notification deadline, so a brand that only calendared 4 August may already be behind on the earlier one. Third, widen substance-screening criteria beyond CMR and PBT hazard statements to include STOT classifications now that neurotoxicity has a demonstrated path onto the Candidate List, since the next equivalent-level-of-concern listing is unlikely to announce itself by hazard type in advance. Brands that hold substance and material data as structured, per-component records can re-run this screening as a query the moment ECHA opens a new Registry of Intentions entry. Brands that track Candidate List exposure through a static CMR checklist find out only once the notification clock is already running.

Two ways to read 4 August