EU CMR cosmetics draft: eleven Annex II substances

• On 8 July 2026 the European Union notified the WTO of draft G/TBT/N/EU/1219, amending Annexes II, III and V of Regulation (EC) 1223/2009. The notification sets a comment deadline of 6 September 2026 and gives "4th quarter 2026" as the proposed date of adoption.
• The draft carries two separate application regimes, and that is its structural spine. Per recital (39), the CMR block would apply from 1 February 2027, the same date as the classifications in Commission Delegated Regulation (EU) 2025/1222, with no transitional period — and that statement sits in a recital, not in the enacting terms. The SCCS block carries 12- and 24-month deadlines from entry into force — and both figures appear in square brackets in the notified text, as placeholders.
• Eleven substances enter Annex II on CMR classification, among them ozone, dinitrogen oxide, trimethyl phosphate and fluoroethylene.
• Following SCCS opinions, the draft also prohibits Benzophenone-1, Benzophenone-2, Basic Brown 16, Basic Blue 99 and prostaglandins and their analogues; sets conditions for Hydroxyapatite (nano), Cannabidiol (CBD) and BHA; splits Butylparaben away from Propylparaben into two Annex V entries; and deletes Annex V entries 16 and 17 — thiomersal and phenylmercuric salts.
• Almost every new entry number is a placeholder: the text literally reads "[OP: please replace with the next consecutive number]". The act is unnumbered and undated ("Brussels, XXX"). It is a draft. This post describes what it says; it is not regulatory advice.

1. The notification record, and the identity of the act

A TBT notification is first of all a record with fixed fields. These are the fields of G/TBT/N/EU/1219:

The attachment is a draft Commission Regulation titled "amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use in cosmetic products of certain substances, including those classified as carcinogenic, mutagenic or toxic for reproduction", marked as having EEA relevance.

Three features of the text itself make clear where in the process it sits:

• It is unnumbered and undated: the header reads "Brussels, XXX" and "of XXX", and the Commission President's signature block at the end of the act is left undated too ("Done at Brussels,").
• Its legal basis is Article 15(1) third sentence, Article 15(2) fourth subparagraph, and Article 31(1) of Regulation (EC) 1223/2009.
• Article 1 provides that Annexes II, III and V to Regulation (EC) No 1223/2009 are amended in accordance with the Annex to the Regulation, and Article 2 sets entry into force "on the twentieth day following that of its publication in the Official Journal of the European Union".

Recital (41) records that the measures are in accordance with the opinions of the Standing Committee on Cosmetic Products.

If you arrived from our general note on how to read a TBT notification, this is that method applied to a real and unusually dense filing.

2. Two application regimes, not one

The structural point is that the draft does not have one application date: it has two separate mechanisms, and each substance falls under one or the other.

2.1. The CMR block: 1 February 2027, no transition

Recital (39) states it directly: the amendments based on the CMR classifications in Commission Delegated Regulation (EU) 2025/1222 should apply from the same date as those classifications, which is 1 February 2027.

Those entries carry no transitional footnote. There is no 12 or 24 months: recital (39) points to the date of the CLP act that produced them. That statement lives in a recital, not in the enacting terms — the draft has only two articles, Article 1 amending the Annexes and Article 2 setting entry into force twenty days after publication, and no deferred-application provision.

2.2. The SCCS block: 12 and 24 months… in brackets

The entries that come from SCCS opinions carry a footnote. In the notified text, footnote (*) to Annex II reads, verbatim:

"From [12 months following entry into force of this Regulation] products containing that substance shall not be placed on the Union market. From [24 months following entry into force of this Regulation] cosmetic products containing that substance shall not be made available on the Union market."

Footnote (**), attached to the restrictive entries in Annexes III and V, repeats the same structure for products that do not comply with the restrictions.

The square brackets are in the original. They are not a typographic device of this post, nor a truncated quotation: they are how a value that is not yet settled is marked in a Commission draft. Right now, the 12 and 24 months are placeholders.

Recital (40) explains what the periods are for: to allow industry to carry out the necessary reformulation, and to give operators a reasonable period to withdraw non-compliant products.

3. The eleven CMR substances entering Annex II

This is the half of the filing its own title announces.

The mechanism, per recitals (1) to (3): the CLP Regulation (EC) 1272/2008 harmonises the classification of substances as carcinogenic, mutagenic or toxic for reproduction in categories 1A, 1B or 2, on the basis of scientific assessment by the Committee for Risk Assessment of the European Chemicals Agency. Article 15 of the Cosmetics Regulation then prohibits the use of CMR-classified substances in cosmetic products, unless the conditions in Article 15(1) second sentence or Article 15(2) second subparagraph are fulfilled. Recital (3) adds that all CMR substances should be included in Annex II and, where relevant, deleted from Annexes III to VI.

Recital (4) closes the door that was left open: no request for use in cosmetic products by way of exception was submitted for these substances. That is why they go straight into Annex II.

The names are reproduced as they appear in the draft:

The reference numbers for these eleven entries do not exist yet: in their place the draft writes "[OP: please replace with the next consecutive number]", an editorial marker to be replaced with the final number in the published edition. How the coupling between a CLP classification and the cosmetic Annexes works in general is covered in our notes on CMR substances in cosmetics and on ECHA, SVHC and CLP.

4. The prohibitions that come from the SCCS

The draft's second driver is a batch of opinions from the Scientific Committee on Consumer Safety. Five substances or groups would move into Annex II, carrying the bracketed transitional footnote from section 2.2:

4.1. The prostaglandin file

This is the one with the longest history. The Commission launched a public call for data in 2020. Industry submitted dossiers on ethyl tafluprostamide (CAS 1185851-52-8) and isopropyl cloprostenate (CAS 157283-66-4) and, by January 2024, also on methylamido-dihydro-noralfaprostal.

The 2026 opinion cited pharmacological activity even at very low concentrations, potential for serious undesirable effects — particularly affecting ocular health — and insufficient evidence to rule out reproductive and developmental toxicity, noting that users of these products are most likely women of child-bearing age. The SCCS could not establish conditions of use under which the substances could be considered safe.

5. The Annex III restrictions

Three substances get conditions rather than a ban. That is the Annex III pattern: limits by product category, plus written conditions.

5.1. Hydroxyapatite (nano) — entry 372 replaced

This is one of the few entries in the whole draft with a real number. CAS 1306-06-5 / 12167-74-7, EC 215-145-7 / 235-330-6.

The conditions are unusually specific: not to be used in applications that may lead to exposure of the end-user's lungs by inhalation; only nanomaterials composed of rod-shaped particles of which at least 87% (in particle number) have aspect ratios equal to or less than 3, with the remaining 13% not exceeding an aspect ratio of 9; particles not coated or surface modified; and a maximum particle length of 122 ± 43 nm.

That level of detail — shape, proportion, coating, length — is characteristic of nanomaterials, where the regulatory identity of a substance depends on morphology and not only on the chemical formula. The basis is opinion SCCS/1677/25, final 26 June 2025. Recital (35) describes the functions: abrasive, bulking, oral care and skin conditioning agent.

5.2. Cannabidiol (CBD) — a new entry, with a THC ceiling

The draft creates an Annex III entry for cannabidiol (CAS 13956-29-1, EC 689-176-3) with a maximum of 0.19% across three scopes: (a) leave-on, (b) rinse-off and (c) oral care products. Basis: SCCS/1685/25, final 26 March 2026. Per recital (30), it is used for skin conditioning and protecting, as an antioxidant, and as an anti-sebum agent.

The condition attached to the limit is a second rule, about an impurity:

"The presence of Delta-9-tetrahydrocannabinol (THC) as an impurity should not exceed 0.00025% (2.5 ppm)."

The legal background sits in recitals (30) and (31), and explains why this entry is new: CBD is not currently regulated by Regulation 1223/2009. Annex II entry 306 prohibits narcotics listed in Tables I and II of the 1961 Single Convention, but following the Court of Justice judgment in Case C-663/18, CBD extracted from cannabis varieties containing no more than 0.2% THC — and, from 1 January 2023, no more than 0.3% — is not considered to fall within that entry. The exception does not extend to THC present in the finished product, which is where the 2.5 ppm ceiling fits.

5.3. Butylated Hydroxyanisole (BHA) — a new entry at 0.07%

Tert-butyl-4-methoxyphenol, CAS 25013-16-5, EC 246-563-8. The limit is 0.07% in (a) leave-on and (b) rinse-off products, with this condition:

"Not to be used in oral care or in products that may lead to exposure of the end-user's lungs by inhalation."

The reason for that narrowed scope is in the opinion itself: SCCS/1682/25, final 26 March 2026, concluded the substance is safe up to 0.07%, but the advice considered dermal use only. Hence an entry limited to dermally applied products, excluding oral care and anything inhalable. BHA is composed of two isomers, 2-tert-butyl-4-methoxyanisole and 3-tert-butyl-4-hydroxyanisole, and recital (8) describes its functions: fragrance ingredient and antioxidant, to prolong shelf life.

Recital (10) places the origin of the file: in 2019 and 2021 the Commission launched public calls for data on the potential endocrine-disrupting properties of Benzophenone-1, Benzophenone-2, BHA and Butylparaben; industry submitted evidence, and the Commission asked the SCCS to assess it.

6. Annex V: the parabens split, and mercury loses its exceptions

6.1. Entry 12a becomes two entries

Today Butylparaben and Propylparaben share entry 12a of Annex V. The draft separates them (recital 16).

Entry 12a is replaced so that it applies exclusively to Propylparaben — propyl 4-hydroxybenzoate and its salts: CAS 94-13-3, sodium propylparaben 35285-69-9, potassium propylparaben 84930-16-5. Its 0.14% limit is the one that already existed. The rewritten entry reads: 0.14% (as acid) for the sum of the individual concentrations; 0.8% (as acid) for mixtures of substances mentioned in entries 12, 12a and 12b, where the sum of the individual concentrations of butyl- and propylparaben and their salts does not exceed 0.14%. Not to be used in leave-on products designed for application on the nappy area of children under three years of age, with the warning "Do not use on the nappy area".

A new entry 12b is created for Butylparaben — butyl 4-hydroxybenzoate and its salts: CAS 94-26-8, sodium butylparaben 36457-20-2, potassium butylparaben 38566-94-8 — with two blocks of conditions:

That breakdown under block (b) is scoped to products intended for children under 10. It is not a general limit, and presenting it as one changes what the entry means. The opinion behind it is titled, literally, "Butylparaben – children exposure" (SCCS/1674/25, final 30 April 2025).

Block (b) further provides that it is not to be used in any sprayable product — including mouth sprays — that may lead to exposure of the end-user's lungs; recital (15) notes that the opinion did not cover such products. It also keeps the nappy-area exclusion for children under three.

The distinction is this: Propylparaben's 0.14% is the existing limit carried over into the rewritten entry, not a new restriction. What is new is the split into two entries and the children's block for Butylparaben.

6.2. Thiomersal and phenylmercuric salts leave Annex V

Annex V entries 16 and 17 — thiomersal (CAS 54-64-8, EC 200-210-4) and phenylmercuric salts, including borate — are deleted, with footnote (**) attached to the deletion: the Annex reads in Annex V entries 16 and 17 are deleted (**), so the bracketed 12- and 24-month periods from section 2.2 travel with these two removals as well. In parallel, Annex II entry 221, which today reads "Mercury and its compounds, except those special cases included in Annex V", is replaced by "Mercury and its compounds", with no exception.

The basis is opinion SCCS/1686/25, final 2 February 2026: the margin of safety, based on renal toxicity as the most sensitive endpoint, is below 100, and the genotoxicity evidence is unclear; the preservatives are not considered safe at currently permitted levels.

Two notes from the recitals. Recital (27) recalls that products containing them must currently carry the warning "Contains Thiomersal" or "Contains Phenylmercuric compounds", and specifies that "phenylmercuric salts" covers all salts composed of the phenylmercury cation (C6H5Hg+) paired with an anion — acetate, benzoate, borate, bromide, chloride, oleate, and so on. Recital (26) places the history: mercury and its compounds have been prohibited in cosmetics since Council Directive 76/768/EEC.

7. The SCCS opinions cited

The draft rests on eleven opinions. These are their numbers and dates as they appear in the recitals:

8. What is still provisional in this document

The inventory is this:

• The act has no number and no date. The header reads "Brussels, XXX" and "of XXX".
• Almost every new entry number is a placeholder. Among the entries the draft creates or amends, the only real numbers are Annex II entry 221, Annex III entry 372, and Annex V entries 12a, 12b, 16 and 17. Everything else reads "[OP: please replace with the next consecutive number]".
• The 12- and 24-month periods sit in square brackets — that is, unsettled.
• The adoption date is a quarter, not a day: "4th quarter 2026" is the notifier's forecast.
• The text can change. That is the point of the comment period the notification closes on 6 September 2026, and some drafts are not adopted in the form they were notified.

The full path, from scientific opinion to application date, is described in the regulatory watch playbook. Comparing it with an act already published — Regulation (EU) 2026/909 — shows the same skeleton once the brackets close: final entry numbers and two dates, one for placing on the market and one for making available.

9. Where the original text is

Everything described above comes from these sources:

• Notification document G/TBT/N/EU/1219 (WTO)
• Notified draft — the Annex, with the amendments
• Notified draft — recitals and articles
• WTO ePing portal — identifier 118610
• European Commission TBT database
• Regulation (EC) No 1223/2009 — EUR-Lex (OJ L 342, 22.12.2009, p. 59)
• Regulation (EC) No 1272/2008, CLP — EUR-Lex (OJ L 353, 31.12.2008, p. 1)
• Commission Delegated Regulation (EU) 2025/1222 — EUR-Lex (OJ L, 20.6.2025)
• Council Directive 76/768/EEC — EUR-Lex
• Court of Justice judgment in Case C-663/18 (CELEX 62018CJ0663)

A naming note: the ePing description field calls the CLP act "Commission Regulation (EU) No 2025/1222", while the draft's recitals give the correct full form, Commission Delegated Regulation (EU) 2025/1222. The delegated form is the one that matches the act.

The current status of any of these substances — what the Annexes say today, not what the draft proposes — lives in the CosIng database and, with legal force, in the consolidated version of Regulation 1223/2009 on EUR-Lex.

10. How this shows up in BD-API

TBT notifications relevant to cosmetics are one of the sources behind our regulatory watch, alongside CosIng, SCCS, Safety Gate and EUR-Lex. Each notification arrives with its document symbol, distribution date and comment deadline, and is explicitly labelled a draft, never a rule in force.

The official ePing description already states the CMR transposition and its application date: it opens by saying the draft measure is required to enact the prohibition on using, as cosmetic substances, those classified as CMR by Commission Regulation (EU) No 2025/1222, which will apply from 1 February 2027. What it does not do is enumerate the eleven CMR substances one by one: it lists nine substances and the removal of the mercury derogations after the word "notably", without entry numbers, without concentrations, and without the wording of the transitional footnotes. That only exists in the PDF.

11. FAQ

What is G/TBT/N/EU/1219? It is the symbol of the notification through which the European Union informed the WTO, on 8 July 2026, of a draft regulation amending Annexes II, III and V of Regulation (EC) 1223/2009 as regards the use in cosmetic products of certain substances, including those classified as CMR.

From when would the CMR prohibitions apply? Recital (39) gives 1 February 2027, the same date from which the classifications in Commission Delegated Regulation (EU) 2025/1222 apply. That block carries no transitional period.

And the SCCS-driven restrictions? They carry a footnote of 12 months for products no longer to be placed on the market and 24 months for products no longer to be made available, counted from entry into force. Both figures appear in square brackets in the draft — that is, not yet fixed.

Which substances does the draft prohibit? Eleven substances on CMR classification — including ozone, dinitrogen oxide, trimethyl phosphate and fluoroethylene — and, following SCCS opinions, Benzophenone-1, Benzophenone-2, Basic Brown 16, Basic Blue 99 and prostaglandins and their analogues. It also deletes Annex V entries 16 and 17 (thiomersal and phenylmercuric salts) and rewrites Annex II entry 221 as "Mercury and its compounds", with no exceptions.

What would the CBD limit be? The draft proposes 0.19% in leave-on, rinse-off and oral care products, on condition that THC present as an impurity does not exceed 0.00025% (2.5 ppm).

Does Butylparaben drop to 0.002%? Only in the block of conditions for products intended for use in children under 10 years of age, and within that block only in leave-on products; the same block gives 0.14% for rinse-off and 0.092% for oral care. The general limit in the new entry 12b remains 0.14% (as acid) for the sum of the individual concentrations.

What changes for Propylparaben? Entry 12a is rewritten to cover it alone, because Butylparaben moves out into a new entry 12b. Its 0.14% is the limit it already had.

Are the draft's entry numbers final? No. The entries the draft creates or amends do carry real numbers — 221, 372, 12a, 12b, 16 and 17 — while the rest carry placeholders of the form "[OP: please replace with the next consecutive number]", which are replaced with the final numbers on publication.

Where is the text? In the two notified PDFs linked in section 9: one holds the Annex with the amendments, the other the recitals and articles.

12. Bottom line

G/TBT/N/EU/1219 is a filing with two halves and two clocks. The first half is bookkeeping: eleven substances classified as CMR under CLP enter Annex II and, per recital (39), would apply from 1 February 2027, the same date as their classifications, with no transition. The second is scientific: eleven SCCS opinions that close off five substances or groups, put conditions on three more, split the paraben entry in two, and take thiomersal and phenylmercuric salts out of Annex V — with 12- and 24-month deadlines that are still in brackets.

And all of it in a document with no number, no date, and entry numbers still to be assigned. The distance between what was notified and what gets published is exactly the space the TBT procedure leaves open.

Notice. This post is informational and does not constitute regulatory or legal advice. It describes a draft notified to the WTO, which may change before adoption and may never be adopted in the form it was notified: the transitional periods appear in square brackets, the new entry numbers are placeholders, and the act is unnumbered and undated. Only the text published in the Official Journal of the European Union has legal force; the notified PDFs linked in section 9 are the source of everything described here.