Product Compliance

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

On 4 February 2026, ECHA added n-Hexane and Bisphenol AF (and its salts) to the REACH Candidate List, bringing it to 253 substances. Most coverage read it as a routine update. What it missed: n-Hexane is the first substance ECHA has ever listed purely for neurotoxicity, under a clause historically reserved for endocrine disruptors, and the six-month deadline to notify ECHA and the SCIP database passed on 4 August.

Naomie HaliouaCDO and co-founder 16 August 2026 · 6 min read

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.

Three nuances that separate signal from noise

A new gateway onto the list, not just a new name

n-Hexane is the first substance ever added to the Candidate List purely for neurotoxicity, via the equivalent-level-of-concern clause. A screening process built to flag CMR and PBT hazard statements would not have flagged it before ECHA did.

Two duties, two different clocks

The Article 33 duty to inform customers down the supply chain started the moment the substances were listed, 4 February. The Article 7(2) notification to ECHA, and the linked SCIP database notification, ran on a separate six-month clock that ended 4 August.

The 0.1% threshold applies per material, not per product

The concentration test runs on each homogeneous material inside an article, not on the finished product's total weight. A rubber seal or an adhesive layer that clears 0.1% w/w on its own triggers the duty, even buried inside a much larger, otherwise clean product.

18 Feb 2025

Slovenia submits its proposal to ECHA's Registry of Intentions to identify n-Hexane as an SVHC under Article 57(f), citing its STOT RE 1 neurotoxicity classification.

Dec 2025

ECHA's Member State Committee agrees to identify n-Hexane as an SVHC, the first such identification based purely on an equivalent level of concern for neurotoxicity.

4 Feb 2026

ECHA adds n-Hexane and Bisphenol AF (and its salts) to the Candidate List, bringing it to 253 entries. The Article 33 supply-chain communication duty applies immediately.

4 Aug 2026

The six-month deadline under Article 7(2) REACH for notifying ECHA, and the linked SCIP database notification, expires for articles containing either substance above 0.1% w/w.

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.

253

the total number of substances on the REACH Candidate List after n-Hexane and Bisphenol AF (and its salts) were added on 4 February 2026

0.1% w/w

the concentration threshold, measured per homogeneous material in an article, above which the Article 33 and Article 7(2) duties apply

6 months

the gap REACH Article 7(2) allows between a substance's Candidate List addition and the deadline to notify ECHA, running from 4 February to 4 August 2026

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

The narrow read

ECHA added two chemicals to its SVHC Candidate List in February 2026, and the six-month deadline for affected article suppliers to notify ECHA passed on 4 August.

The structural read

n-Hexane's listing under REACH's equivalent-level-of-concern clause is the first time neurotoxicity alone has cleared that bar, so a CMR-and-PBT screening net now has a demonstrated hole: the two duties that followed, immediate supply-chain disclosure and a six-month ECHA and SCIP notification, both started well before 4 August, not on it.

Sources & references

Frequently asked questions

What actually happened on 4 February and 4 August 2026?

On 4 February 2026, ECHA added two substances, n-Hexane and Bisphenol AF (and its salts), to the REACH Candidate List of substances of very high concern, bringing the total to 253. Under Article 7(2) of the REACH Regulation, companies placing articles containing either substance above 0.1% weight by weight on the EU market, above a one-tonne-per-year threshold, had six months to notify ECHA. That notification deadline, and the linked SCIP database notification under the Waste Framework Directive, passed on 4 August 2026.

Why is n-Hexane's listing different from previous SVHC additions?

Every SVHC identified before n-Hexane was added because it is carcinogenic, mutagenic, toxic for reproduction, or persistent and bioaccumulative. n-Hexane was identified under REACH Article 57(f), the 'equivalent level of concern' clause, based solely on its classification for nerve damage after repeated exposure (STOT RE 1). ECHA had used that clause almost exclusively for endocrine disruptors before Slovenia's proposal, so this is the first time neurotoxicity alone has qualified a substance for the Candidate List.

What should brands do now that the notification deadline has passed?

Brands should first confirm whether any article they place on the EU market contains n-Hexane or Bisphenol AF above 0.1% w/w in any homogeneous material, common in adhesives, coatings, rubber components and specialty polymers, and file the Article 7(2) and SCIP notifications if they have not already, since these obligations do not disappear once the deadline passes, only the compliance status changes to non-compliant. Second, they should widen substance-screening criteria beyond CMR and PBT hazard statements to include STOT classifications, since the equivalent-level-of-concern clause is no longer limited in practice to endocrine disruptors.