On 28 April 2026 the European Commission published Commission Regulation (EU) 2026/909, amending Annexes II, III, IV and V of the Cosmetics Regulation (EC) No 1223/2009 in response to a batch of recent Scientific Committee on Consumer Safety (SCCS) opinions. The regulation entered into force on 18 May 2026 and revises the permitted conditions for roughly a dozen ingredients spanning fragrance allergens, a UV filter, hair dye components, and zinc compounds used in oral care.
The headline change is a straightforward prohibition: Triphenyl Phosphate, used mainly as a plasticiser in nail polish and other manicure products, moves onto the list of prohibited substances after the SCCS said available data did not allow it to rule out genotoxic potential. Everything else in the package is a restriction rather than a ban — tighter concentration caps, new age-banded limits, or a new impurity ceiling — but the compliance clock is the same across the whole amendment.
Products that do not comply may not be placed on the EU market from 1 January 2027, and non-compliant stock already on shelves must be fully withdrawn by 1 July 2028. Some trade sources cite a later sell-through date, 1 August 2028, specifically for the Citral-related entries (geranial and neral); this is worth confirming against the consolidated Annex III text before finalizing a reformulation timeline. The amendment reaches nail care, fine fragrance and cosmetics using citrus-derived fragrance materials, sunscreens formulated with the UV filter DHHB, oral care products containing zinc salts, and semi-permanent hair colorants.
What changes under Regulation (EU) 2026/909?
- Triphenyl Phosphate: moves from permitted plasticiser use to full prohibition (Annex II) — primarily affects nail polish and nail enamel formulations.
- Benzyl Salicylate: revised, product-type-specific maximum concentration caps introduced on top of the existing fragrance-allergen disclosure threshold.
- Citral (as geranial and neral): tailored maximum concentration limits by product category, aimed at reducing sensitization risk.
- Water-soluble zinc salts (zinc chloride, sulphate, gluconate, glutamate, and newly added zinc citrate): harmonized, age-banded limits in oral care — reported at roughly 1% zinc in adult toothpaste and roughly 0.72% zinc in toothpaste intended for infants aged 6 to 12 months.
- DHHB (UV filter): remains permitted up to 10%, but a new, stricter limit applies to its manufacturing impurity, di-n-hexyl phthalate (DnHexP).
- HC hair dyes (including HC Blue No 18, HC Yellow No 16, HC Red No 18, and Hydroxypropyl-p-phenylenediamine): new maximum use levels, reported in a roughly 0.35% to 2% range depending on the substance, plus mandatory, more prominent allergy warning wording on pack.
- Aluminium-related entries are also understood to be revised in this package; public summaries are not fully consistent on the exact figures, so these should be checked directly against the Official Journal text.
- Compliance deadline: no placing of non-compliant product on the market from 1 January 2027; full market withdrawal by 1 July 2028 (verify any category-specific extensions).
Clarification: “prohibited” and “restricted” are not the same compliance problem
Triphenyl Phosphate cannot be reformulated around at a lower percentage — it has to be removed and replaced entirely, which for a nail polish plasticiser usually means a full stability and performance retest of the reformulated product, not just a label change. Benzyl Salicylate, Citral, DHHB and the zinc salts, by contrast, remain permitted ingredients; the work is recalculating exposure at the new caps and confirming the formula stays under them — a smaller, but still real, analytical and documentation task.
Clarification: two different concentration rules can apply to the same molecule
Benzyl Salicylate and Citral are both established fragrance allergens, already subject to the Regulation (EU) 2023/1545 disclosure thresholds (0.001% leave-on / 0.01% rinse-off) under Annex III. Regulation (EU) 2026/909 adds a separate, generally lower, restricted-use ceiling on top of that disclosure trigger. A formula can be correctly labelled for allergen disclosure and still be non-compliant with the newer restricted-use cap — the two checks have to be run separately, against separate Annex entries.
What should cosmetics companies check?
- Audit nail care and other plasticiser-containing formulations for Triphenyl Phosphate. Where present, start reformulation and re-stability-testing now — a straight ban leaves no lower-concentration fallback.
- Recalculate Benzyl Salicylate and Citral levels against the new restricted-use caps, separately from the existing fragrance-allergen disclosure threshold, by product category.
- Check oral care ranges, especially children’s and infant toothpaste, against the new age-banded zinc limits. Confirm which zinc salts are used and whether zinc citrate or zinc sulphate — newly brought into scope — appear in any formula.
- Request current certificates of analysis for DHHB confirming DnHexP impurity levels from UV filter suppliers, since routine actives testing will not by itself confirm impurity compliance.
- Update hair dye product labels for the new maximum use levels and allergy warning wording, and confirm current stock formulations sit under the revised caps.
- Update the CPSR and Product Information File to cite Regulation (EU) 2026/909 as the current legal basis, and flag any formula that needs reassessment before the January 2027 cutoff.
Common implementation risks
- Assuming reformulation is only needed for the outright ban, and missing the several ingredients that are merely subject to new, lower caps.
- Testing DHHB content but not its DnHexP impurity, which needs a more sensitive analytical method than a routine actives assay.
- Applying the general fragrance-allergen disclosure threshold to Benzyl Salicylate or Citral and assuming that also covers the newer restricted-use limit.
- Underestimating the lead time for nail polish reformulation and re-stability testing once Triphenyl Phosphate is removed.
- Working from raw-material supplier specifications that have not yet been updated to reflect the new limits.
- Using production or packing dates rather than first-supply dates to judge whether a batch falls before or after the 1 January 2027 cutoff.
- For products manufactured outside the EU, assuming the Responsible Person will automatically receive updated compliance documentation from an overseas supplier without requesting it directly.
How Makrolife can support Regulation (EU) 2026/909 compliance
- Quantitative testing for Triphenyl Phosphate, Benzyl Salicylate and Citral against the new restricted-use limits.
- Trace-level impurity analysis for DHHB-containing UV filter systems, including DnHexP.
- Zinc content verification in oral care formulations against the new age-banded limits.
- Reformulation and stability support for nail care products affected by the Triphenyl Phosphate ban.
- CPSR and Product Information File updates that cite the current legal basis.
The goal across all five is the same: one consistent regulatory record across formula, label and safety file, for every product line this amendment touches.
Do your nail, fragrance, oral care or hair colour lines need a Regulation (EU) 2026/909 check?
With the 1 January 2027 placement cutoff a few months away, reformulation and re-stability testing for any Triphenyl Phosphate-containing product needs to start now, and the restricted-use recalculations for Benzyl Salicylate, Citral, DHHB and zinc salts are easy to underestimate.
Request a Regulation (EU) 2026/909 compliance check from Makrolife Biotech for your affected formulations.
Sources
- Commission Regulation (EU) 2026/909 — EUR-Lex
- Keeping pace with science: EU updates cosmetic ingredient rules — European Commission (DG GROW)
- EU Regulation (EU) 2026/909: comprehensive interpretation — REACH24H
- Cosmetics Regulation (EU) 2026/909: new restrictions, prohibitions and ingredient conditions — SGS
- Omnibus 2 on cosmetic ingredients: Triphenyl Phosphate banned — Complife Group
- EU updates cosmetic regulation: restrictions on 12 cosmetic ingredients — CIRS Group
