WTO TBT · Silver · SCCS

Silver in cosmetics: a draft loosens the May limits

12 min
  • On 30 July 2026 the European Union notified the WTO of draft G/TBT/N/EU/1227, amending Annexes III and IV of Regulation (EC) 1223/2009 as regards the use of silver in cosmetic products. The comment deadline is 28 September 2026 and the proposed date of adoption is "4th quarter 2026".
  • The draft loosens conditions rather than tightening them, and the conditions it corrects have been applying since 1 May 2026, the date from which Regulation (EU) 2026/78 applies. Article 2 of this draft names that same date. It would therefore be retroactive: it would displace the January conditions from the very day they began to apply.
  • It touches two entries, both replaced in full: 379 in Annex III and 142 in Annex IV, both covering the same substance — silver powder, Silver, CAS 7440-22-4, EC 231-131-3.
  • The chain that produced it is legible end to end: CLP classifies silver as a CMR category 2 substance in June 2024, the Cosmetics Regulation transposes that classification in January 2026, industry submits data, and the SCCS concludes that silver is safe under conditions that go beyond the transposed ones.
  • This does not make silver safe in general: nano and massive silver remain prohibited under Annex II entry 1727. The act is unnumbered and undated. It is a draft; this post describes what it says and is not regulatory advice.

1. A regulation rewritten while it is already applying

The first thing about G/TBT/N/EU/1227 is not a new prohibition — it is a correction. It replaces two annex entries on silver powder and sets their application from 1 May 2026, the same date from which Regulation (EU) 2026/78 applies, the act that introduced the conditions now being rewritten.

That overlap of dates is the spine of the file. Recital (8) states it plainly: the regulation should enter into force on the day of its publication and apply from 1 May 2026 in order to ensure "a seamless application of this Regulation" alongside Regulation (EU) 2026/78. If the draft is adopted as notified, the looser conditions would replace the stricter ones with effect from the very day the stricter ones began to bite.

That those conditions are already running is what puts the file in a hurry, and recital (7) says so with one word that admits no other reading — withdrawals. Its stated purpose is "to ensure the smooth functioning of the internal market and to avoid unnecessary withdrawals or restrictions on cosmetic products containing micron-sized silver (silver powder) ... that are considered safe in the light of the latest scientific assessment of the SCCS". Nothing is withdrawn from a market over a rule that does not yet bind: the sentence presupposes a live restriction. Recital (6) says it from the other side — because the conditions in entries 379 and 142 apply from 1 May 2026 and do not fully reflect the most recent scientific assessment of the SCCS, it is necessary to amend them "without delay".

And the direction of travel is the opposite of the usual one. Recital (5) puts the objective as reflecting the latest scientific knowledge and ensuring a high level of protection of human health "while avoiding unnecessary restrictions on safe uses". Recital (7) says the same thing differently — aligning the regulatory framework with the most recent scientific evidence and alleviating certain restrictions — and adds that the regulation should enter into force as a matter of urgency.

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

A TBT notification is a record with fixed fields, read the way our general note on TBT notifications describes:

FieldValue
Document symbolG/TBT/N/EU/1227
ePing identifier119047
Notifying memberEuropean Union
Notification typeRegular notification
Distribution date30 July 2026
Comment deadline28 September 2026
Proposed date of adoption"4th quarter 2026"
Technical regulationYes
Urgent procedureNo
Stated objectiveProtection of human health or safety (TBT)
ICS code71.100.70 — Cosmetics. Toiletries
Products coveredCosmetics

The attachment is a draft Commission Regulation amending Regulation (EC) No 1223/2009 as regards the use in cosmetic products of silver. It is unnumbered and undated: the header reads "Brussels, XXX" and "of XXX", and the Commission President's signature block is left undated too ("Done at Brussels,").

Its legal basis is Article 31(1) of Regulation (EC) 1223/2009, and that alone. The other cosmetics draft notified this summer, G/TBT/N/EU/1219, also invokes Article 15: that one is the CMR-classification mechanism, this one the review of annexes in the light of a scientific opinion.

Article 1 provides that Annexes III and IV are amended in accordance with the Annex to the Regulation. Article 2 reads, verbatim:

"This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union. It shall apply from 1 May 2026."

Recital (8) also records that the measures are in accordance with the opinion of the Standing Committee on Cosmetic Products.

3. Entry into force: the record and Article 2 disagree

The notification's two sources do not match, and the gap between them is three weeks. The ePing field describing the proposed entry into force says "20 days from publication in the Official Journal of the EU." Article 2 of the attached draft says "on the day of its publication".

The document governs. Article 2 is the proposed operative text; the record field is an administrative summary. And it is recital (7) itself that calls for entry into force as a matter of urgency, which fits Article 2 rather than the summary. Both sources are in section 10: the 20-day field sits in the WTO notification document, and Article 2 in the draft PDF.

This is the second cosmetics notification running in which the summary field describes entry into force differently from how the enacting terms fix it. That is an observation about where the datum lives: of the two texts, only the act's will reach the Official Journal.

4. The chain that produced the draft

Recitals (1) to (4) reconstruct a two-year, two-regulation route — an unusually clean example of how CLP and the Cosmetics Regulation couple together.

19 June 2024 — CLP classifies silver. Commission Delegated Regulation (EU) 2024/2564 amends Regulation (EC) No 1272/2008 and classifies silver (CAS 7440-22-4) as a CMR category 2 substance, toxic for reproduction. The classification distinguishes three particle-size ranges:

FormParticle diameter
Silver massive≥ 1 mm
Silver powder100 nm < diameter < 1 mm
Silver nanoparticles1 nm < diameter ≤ 100 nm

That split by size is what spreads the file across three different annexes. The general mechanism — a CLP classification pulling cosmetic consequences behind it — is covered in our notes on CMR substances in cosmetics and on ECHA, SVHC and CLP.

12 January 2026 — the Cosmetics Regulation responds. Regulation (EU) 2026/78 transposes the classification: it amends entry 1727 of Annex II to include silver nano and silver massive among the prohibited substances; adds micron-sized silver to the restricted list in Annex III; and amends entry 142 of Annex IV to allow silver powder as a colorant only under the conditions the SCCS considered safe. It applies from 1 May 2026.

August 2025 — industry submits data. Information is submitted aimed at demonstrating the safety of micron-sized silver in specific cosmetic products.

The SCCS opinion. The Scientific Committee on Consumer Safety reassesses the file "taking into account additional exposure scenarios and refined toxicological data" and concludes that silver is safe under conditions that go beyond those laid down in Regulation (EU) 2026/78.

This draft — the correction. It amends entries 379 and 142 "without delay", applying from 1 May 2026.

5. What the SCCS concluded

Recital (4) carries the conclusion, and its reasoning is specific: micron-sized particulate silver does not penetrate the skin. On that basis the SCCS considers it safe up to:

  • 0.2% in rinse-off cosmetic products
  • 0.3% in leave-on cosmetic products
  • 0.2% in oral exposure products
  • 0.3% in nail products

In cosmetic products intended for children, the opinion keeps those same concentrations with one exception: in oral products, micron-sized particulate silver is safe up to 0.05% in mouthwash products.

5.1. The opinion's two dates, both correct

The opinion is SCCS/1687/25, scientific advice on silver (CAS/EC No. 7440-22-4 / 231-131-3) used in cosmetic products, and it carries two dates that are easily conflated:

  • Preliminary version: 17 December 2025. Final version: 26 March 2026, per footnote 4 of the draft.
  • Published: 24 April 2026, per recital (3) of the draft and the ePing record's description.

Both are correct and refer to different events: the committee closing the final version of the document, and that document being published. Neither corrects the other.

6. The two entries being replaced

The draft's Annex is short: it replaces two entries in full, both covering the same substance identity.

Silver (powder) [100 nm < particle diameter < 1 mm] · Name of Common Ingredients Glossary: Silver · CAS 7440-22-4 · EC 231-131-3.

6.1. Annex III, entry 379

Product typeMaximum concentration in ready for use preparation
(a) Rinse-off products0,2 %
(b) Oral products with the exception of (c)0,2 %
(c) mouthwash for children0,05 %
(d) Leave-on products0,3 %
(e) Nail products0,3 %

The draft states the (d) and (e) limit jointly: "For both (d) and (e): 0,3 %".

The "Other" column sets two conditions, verbatim:

"Only silver powder with porous and sintered particle structure. Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation."

The first is not a concentration condition but one of particle morphology, the same kind of criterion that governs nanomaterials: regulatory identity turns on physical form, not only on chemical formula.

6.2. Annex IV, entry 142

This is the colorant list, so the entry carries that annex's own fields:

FieldValue
Colour Index number77820
ColourWhite
Product type(a) Leave-on products · (b) Nail products
Maximum concentration"For both (a) and (b): 0,3 %"

The "Other" column repeats the same double condition as entry 379: porous and sintered particle structure, and no application that may lead to exposure of the end-user's lungs by inhalation.

7. What this draft does not touch

Silver nano and silver massive remain prohibited under Annex II entry 1727, as Regulation (EU) 2026/78 left it: the draft does not mention them in its Annex. The SCCS's reasoning does not extend to them either, because the safety conclusion rests on micron-sized particles not penetrating the skin — an argument that by construction says nothing about a different size range.

So the reading of the draft is not "silver becomes safe", but "the conditions of use for one specific size range widen relative to those set in January 2026".

8. Two notified drafts, two directions

This summer the European Union notified two cosmetics drafts three weeks apart, and they point opposite ways. G/TBT/N/EU/1219, distributed on 8 July, tightens: it puts eleven CMR substances into Annex II, prohibits five substances or groups on SCCS opinions, and takes thiomersal and phenylmercuric salts out of Annex V. G/TBT/N/EU/1227, distributed on 30 July, loosens.

What the two share is an SCCS opinion behind what they propose — the 1219 also runs on the CLP CMR classifications, via Article 15 — and the same procedure: TBT notification, comment period, adoption proposed for the fourth quarter of 2026. What differs is where the scientific evidence pushes in each file.

9. What is provisional in this document

  • The act has no number and no date. The header reads "Brussels, XXX" and "of XXX".
  • The date of adoption is a quarter, not a day: "4th quarter 2026" is the notifier's projection.
  • Entry into force is described two different ways in the record and in the enacting terms, as section 3 sets out.
  • The text can change. That is the point of the comment period, which the notification closes on 28 September 2026; some drafts are never adopted in the form they were notified.

The full route from scientific opinion to date of application is described in the regulatory watch playbook, and an act that has already been published — Regulation (EU) 2026/909 — shows the same skeleton once it is closed. The current status of silver in the annexes lives in the CosIng database and, with legal force, in the consolidated version of Regulation 1223/2009 on EUR-Lex.

10. Where the original text is

Everything described above comes from these sources:

One note on the attachments: here PDF 26_03999_00_e holds the recitals and articles and 26_03999_01_e holds the Annex. In G/TBT/N/EU/1219 the order was the reverse — attachments are identified by what they contain, not by their sequence number.

11. How this shows up in BD-API

TBT notifications relevant to cosmetics are one of the sources feeding our regulatory watch, alongside CosIng, the SCCS, Safety Gate and EUR-Lex. Each one enters with its document symbol, distribution date and comment deadline, and is labelled explicitly as a draft, not as a rule in force.

The official record's description summarises the file in a few lines: it mentions the SCCS opinion published on 24 April 2026 and the purpose of adjusting the conditions of use. It does not carry the concentrations by product category, the entry numbers, the Colour Index number or the "Other" column. Those live only in the Annex PDF.

12. FAQ

From when would it apply? Article 2 sets application from 1 May 2026 and entry into force on the day of publication. Since the draft has not been adopted, that date precedes its own publication: it would be retroactive, and it coincides with the date from which Regulation (EU) 2026/78 applies.

Why does the ePing record say 20 days? Because the summary field and Article 2 of the draft describe entry into force differently. The act's text is what fixes the rule; section 10 links the notification document, where the 20-day field sits, and the draft PDF.

So is silver safe in cosmetics now? Not in general. The draft widens the conditions of use for one specific size range. Silver nano and silver massive remain prohibited under Annex II entry 1727 per Regulation (EU) 2026/78, and the draft does not amend that.

Is the opinion from March or April 2026? Both. SCCS/1687/25 has a preliminary version of 17 December 2025 and a final version of 26 March 2026; recital (3) places its publication on 24 April 2026.

13. Bottom line

G/TBT/N/EU/1227 is a small file with an uncommon structure. Two annex entries, one substance, one opinion — and a date of application that points backwards, to 1 May 2026, so it slots seamlessly against the January regulation it corrects.

Its interest is not volume but traceability: a CLP classification from June 2024, its transposition into the cosmetic annexes in January 2026, industry data from August 2025, an SCCS reassessment with additional exposure scenarios, and finally a draft that widens the conditions because the science supports more than the conditions that had been transposed. Every link is dated and cited in the recitals. And, like everything notified to the WTO, it is still a proposal: no number, no date, and adoption projected for a whole quarter rather than a day.


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 act is unnumbered and undated, and its date of adoption is a quarterly projection. Only the text published in the Official Journal of the European Union has legal force; the notified PDFs linked in section 10 are the source of everything described here.

See how BD-API's regulatory watch works →

WTO TBT notifications, CosIng, SCCS, Safety Gate and EUR-Lex in one feed, with every draft labelled for what it is.

This article was written with the assistance of artificial intelligence and was reviewed and verified by a person against the official sources (EUR-Lex, CosIng, European Commission). More on our use of AI

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