- ECHA is not your cosmetics regulator — it runs chemicals under REACH and CLP. But through Article 15 of Regulation (EC) 1223/2009, its decisions decide what gets banned from cosmetics.
- Two sources, two jobs: the SVHC Candidate List is your early-warning radar; CLP Annex VI is the direct trigger — a harmonised CMR classification becomes an almost-automatic cosmetics ban.
- 250+ SVHCs, 4,000+ harmonised classifications, ATPs roughly yearly, CMR Omnibus rounds in between — and the Lilial case proves the whole chain end to end.
1. What ECHA is, and why a chemicals agency matters to a cosmetics team
The European Chemicals Agency (ECHA) administers the two big horizontal chemical laws of the EU: REACH (Regulation (EC) No 1907/2006), which registers and controls substances, and CLP (Regulation (EC) No 1272/2008), which classifies and labels their hazards. Neither is a cosmetics law. ECHA does not write the Cosmetics Regulation, does not run the CPNP, and does not answer to the SCCS.
So why should a Regulatory Affairs lead at a cosmetics company watch ECHA at all? Because of one hinge: Article 15 of Regulation (EC) No 1223/2009. That article ties the fate of an ingredient in your cream to a hazard classification decided over at ECHA. When a substance is classified CMR (carcinogenic, mutagenic, or toxic for reproduction) in the chemicals world, it is — by default — prohibited in cosmetics. The decision is made by a chemicals agency; the consequence lands on your formulation.
There are two ECHA data sources you have to track, and they do not play the same role. Confusing them is the most common mistake in this whole area, so let us take them one at a time.
2. The SVHC Candidate List: your early-warning radar
The Candidate List of substances of very high concern (SVHC) for authorisation is a list ECHA maintains under REACH. A substance lands on it when it meets one of the criteria in Article 57 of REACH:
- CMR category 1A or 1B;
- PBT (persistent, bioaccumulative, toxic);
- vPvB (very persistent, very bioaccumulative);
- equivalent level of concern decided case by case — explicitly including endocrine disruptors, and, as of the n-Hexane addition (CAS 110-54-3), neurotoxicity.
As of the update on 4 February 2026, the list holds 253 entries. ECHA refreshes it roughly twice a year — typically January and June — though 2025 saw extra rounds, so treat any count as a snapshot: confirm the live number on ECHA the day it matters.
Here is the nuance that almost every competing article gets wrong, and the single biggest reason to read this one carefully: being on the Candidate List does not, by itself, ban a substance in a cosmetic. The legal obligations the Candidate List triggers — the 0.1% w/w information duty, ECHA notification, the SCIP database — attach to articles (think a phone casing, a textile). A cosmetic product is a mixture/product, not an "article," so those duties do not bite it directly.
What the Candidate List gives a cosmetics team is signal. It is the radar. A substance that lands here is on a regulatory trajectory: Candidate List → Authorisation List (Annex XIV) or Restriction (Annex XVII) under REACH, and — separately — toward an SCCS opinion and an Annex II/III action under the Cosmetics Regulation. Many SVHCs are cosmetic ingredients. Butylparaben is the cleanest example: added to the Candidate List in June 2020 as an endocrine disruptor, while still permitted as a preservative up to 0.14%. The June 2025 round added linear siloxanes (vPvB) used in skin creams, hair conditioners and antiperspirants. When you see your ingredient here, you do not have a ban yet — you have a warning that one is being built.
3. CLP Annex VI: the direct trigger
If the Candidate List is the radar, Annex VI to the CLP Regulation is the trigger that actually fires.
Annex VI (specifically Table 3) is the list of harmonised classifications — the hazard class, hazard statements (H-codes), pictograms and specific concentration limits that are legally fixed for a substance across the entire EU. It currently holds over 4,000 entries. It is updated through ATPs (Adaptations to Technical Progress), issued roughly once a year as Commission Delegated Regulations — the most recent being Regulation (EU) 2025/1222, which applies from 1 February 2027, on the heels of Regulation (EU) 2024/2564, mandatory from 1 May 2026.
The classifications that matter most for cosmetics are the CMR ones:
- Category 1A — known human CMR;
- Category 1B — presumed human CMR (animal evidence);
- Category 2 — suspected CMR.
One technical point that separates a professional from a copy-paste blog: the classification that triggers a cosmetics ban is the harmonised one in Annex VI — not a manufacturer's self-classification. So the thing to watch is the ATP. When a new CMR entry lands in Annex VI Part 3, a clock starts ticking on the cosmetics side.
4. Article 15: where ECHA's decision lands on your formula
This is the spine of the whole story. Article 15 of Regulation (EC) No 1223/2009 says, in plain terms:
- Article 15(1) — CMR Category 2: prohibited in cosmetic products — unless the substance has been evaluated by the SCCS and found safe for use in cosmetics.
- Article 15(2) — CMR Category 1A or 1B: prohibited — unless all four of these narrow conditions are met at once:
- (a) the substance complies with food-safety requirements of Regulation (EC) No 178/2002;
- (b) there are no suitable alternative substances, documented in an analysis of alternatives;
- (c) the application is for a particular use of the product category with known exposure;
- (d) it has been evaluated and found safe by the SCCS, taking account of overall exposure and vulnerable population groups.
In practice the four conditions are almost never all met, so a CMR 1A/1B classification is, for most purposes, a ban. And the Commission is on a clock: it has to act to amend the cosmetics Annexes within 15 months of the CMR classification taking effect.
So the full chain, the one no competitor lays out end to end, is:
A harmonised CMR classification enters Annex VI of CLP (via an ATP) → Article 15 of the Cosmetics Regulation prohibits it "in principle" → the Commission formally moves it to Annex II (the prohibited list) through a CMR Omnibus regulation.
5. The cascade in practice: cases with CAS numbers
The chain is not theory. Here are the ones to know:
| Substance | INCI / CAS | What happened |
|---|---|---|
| Lilial / BMHCA | Butylphenyl Methylpropional · CAS 80-54-6 | The textbook case. Classified Repr. 1B under CLP, then moved to Annex II by the 4th CMR Omnibus, Regulation (EU) 2021/1902 — banned in cosmetics from 1 March 2022. |
| Titanium Dioxide | Titanium Dioxide / CI 77891 · CAS 13463-67-7 | Classified Carc. 2 (by inhalation) for powder forms via Reg (EU) 2020/217 → annulled by the EU General Court, annulment upheld by the CJEU on 1 August 2025, and the classification removed from Annex VI in December 2025. Proof that a harmonised classification is contestable in court — and that an ingredient's cosmetic fate can swing on it. SCCS is re-assessing it. |
| Formaldehyde + releasers | Formaldehyde · CAS 50-00-0 | Carc. 1B, in Annex II. Its releasers (DMDM hydantoin, imidazolidinyl urea) now require a "releases formaldehyde" label above 0.001% (10 ppm) — full compliance by 31 July 2026. |
| TPO | Trimethylbenzoyl Diphenylphosphine Oxide | Moved from restricted to prohibited by Regulation (EU) 2025/877 (CMR Omnibus VII), in force 1 September 2025 — relevant to UV nail gels. |
| Butylparaben | Butylparaben | On the SVHC Candidate List since June 2020 as an endocrine disruptor — the early-warning side of the same coin. |
Those CMR Omnibus rounds are the formal step that writes a classification into Annex II: Omnibus VII = Regulation (EU) 2025/877 (from 1 Sep 2025) and Omnibus VIII = Regulation (EU) 2026/78 (from 1 May 2026, aligned with the latest ATP). Each one is a batch of ingredients leaving the market on a fixed date.
6. The monitoring problem
Two sources, two cadences, two formats — and both public and free:
- The Candidate List updates ~twice a year, and you need to know not just that it changed, but whether one of your ingredients just appeared on the radar.
- Annex VI carries 4,000+ entries and shifts with each ATP. A single new CMR classification buried in a delegated regulation can start a 15-month countdown to a ban on a substance in your formulations.
- Neither one pushes you a notification. Neither one knows or cares what is in your portfolio.
Done by hand, this is two separate files downloaded on two different schedules, diffed against the previous versions, and cross-referenced — entry by entry — against your ingredient list, watching specifically for the CMR flag that matters. It is exactly the kind of task that quietly slips when the person who owned it is on holiday.
7. How BD-API handles it
Here is how we automate both sources, without rehashing the technical detail already on our Regulatory Watch page:
- Scheduled monitoring, per source: BD-API checks the SVHC Candidate List every Monday at 09:00 UTC and CLP Annex VI monthly. It reads each file's ETag and Last-Modified first and only downloads when something actually changed.
- Snapshot + diff: we keep the previous version of all 250+ SVHC entries and the 4,000+ Annex VI classifications, and compute the exact delta. Only real changes — a new SVHC, a new or tightened CMR classification, a removed entry — generate an event. A bootstrap guard seeds the baseline silently on first load instead of firing thousands of false alarms.
- Smart cross-referencing: every changed substance is matched against the CosIng INCI inventory tied to your portfolio. If a new CMR classification touches an ingredient you use, it is flagged high-criticality — because that is the one with a 15-month fuse on it.
- AI enrichment: a source-specific analyser extracts the substance, CAS number, hazard class, the affected cosmetics Annex and proposed action — structured JSON, ready for your pipeline.
- Signed delivery: email plus webhook with HMAC-SHA256 signature.
- Granular subscription: take ECHA on its own, or combine it with SCCS, DG SANTE, Safety Gate, EUR-Lex and IFRA. No service restarts required.
The philosophy is the same as with every source we cover: BD-API delivers the structured data, your regulatory team decides what to do with it. We do not replace human judgement — we hand back the hours you currently spend reconciling two spreadsheets against your formulations.
8. Frequently asked questions
What is the SVHC Candidate List? ECHA's list, under REACH, of substances of very high concern (CMR, PBT, vPvB, endocrine disruptors and equivalent concern) that are candidates for authorisation. It holds 253 entries as of February 2026.
Does a substance on the SVHC Candidate List get banned in cosmetics? Not automatically. The Candidate List's obligations apply to articles, not cosmetic products. For cosmetics it is an early-warning signal; the actual ban runs through Article 15 / Annex II or a REACH restriction.
What is CLP Annex VI? The table of harmonised hazard classifications (over 4,000 entries), legally fixed across the EU and updated via ATPs.
Why does a CMR classification ban a substance in cosmetics? Because Article 15 of Regulation 1223/2009 prohibits CMR-classified substances in cosmetics by default, with only narrow SCCS-evaluated derogations.
What is a CMR Omnibus? The Commission regulation that formally moves newly CMR-classified substances into Annex II of the Cosmetics Regulation. The most recent are Reg (EU) 2025/877 and 2026/78.
Why was Lilial banned? It was classified Repr. 1B under CLP, which triggered Article 15; Regulation (EU) 2021/1902 moved it to Annex II, banning it from 1 March 2022.
Is titanium dioxide banned in cosmetics? No. Its CMR classification was annulled by the EU courts (upheld by the CJEU in August 2025) and removed from Annex VI; the SCCS is re-assessing it.
9. Bottom line
The trap with ECHA is assuming that because it is "the chemicals agency," it is somebody else's problem. It is not. Annex VI is where the bans on your ingredients are actually born, and the Candidate List is the radar that sees them coming a year or two out. The Lilial cascade — CLP classification, Article 15, Omnibus, Annex II — is the template, and it runs again with every ATP.
The question is not whether ECHA matters to a cosmetics company. It is how to watch two chemical inventories — 250-plus SVHCs and 4,000-plus harmonised classifications — and catch the one CMR entry that lands on a substance in your formula, before the 15-month clock runs out.
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