From an assessment standpoint, the point to grasp early is that an annex amendment does not merely alter a label. Where a maximum concentration changes, the exposure calculation and the Margin of Safety derived from it change with it, and the Part B conclusion no longer rests on the position it was signed under. Each affected product needs its CPSR revisited, not simply its artwork corrected.
The principal instrument: Regulation (EU) 2026/909
Regulation (EU) 2026/909 amends Annexes II, III, V and VI. It was adopted on 27 April 2026, published in the Official Journal on 28 April 2026 and entered into force on 18 May 2026. It addresses twelve named substances, ranging from fragrance ingredients such as Benzyl Salicylate and Citral to hair dyes, aluminium-containing ingredients and water-soluble zinc salts.
Most of its provisions carry a transition period, and the two dates reflect the distinction in Article 2(1) between placing on the market and making available on the market. Non-compliant products may no longer be placed on the EU market from 1 January 2027, and may no longer be made available from 1 July 2028. The exception is the Citral isomers Neral and Geranial, for which the "made available" date is 1 August 2028. The hair dye and preservative provisions apply without a transition period.
One practical caution when reading the instrument: the enacting terms contain no dates beyond entry into force. Every transitional date sits in a footnote within the Annex, attached to individual entries. Reading the articles alone will not tell you which of your products is on which clock.
Regulation (EU) 2026/78 preceded it. Adopted on 12 January 2026, it entered into force on 2 February 2026 and has applied since 1 May 2026. It amends Annexes II, III, IV and V.
Changes at a glance
Regulation (EU) 2026/909 (in force 18 May 2026)
- Triphenyl Phosphateis added to Annex II, the list of prohibited substances.
- Benzyl Salicylateand Citral receive new maximum concentrations differentiated by product type — the Citral table runs from 0.032% in deodorants and antiperspirants to 1.2% in hair and rinse-off products, and Benzyl Salicylate from 0.004% in oral products to 4% in fragrance products. Both must be declared on the label above the usual fragrance thresholds of 0.001% in leave-on and 0.01% in rinse-off products (Annex III).
- Water-soluble zinc saltsare restricted by product type, expressed as zinc, with distinct limits for oral products intended for young children — 0.72% in toothpaste for children aged 6 months to 1 year, against 1% for users over 1 year (Annex III).
- Aluminium-containing ingredientsreceive a new restriction, expressed as Al, with maximum concentrations across eighteen product categories and warnings for certain leave-on skin products and talcum powder (Annex III).
- Acetylated Vetiver Oilreceives maximum concentrations by product type and must be stabilised with 1% alpha-tocopherol at raw material level — a supplier specification question, not a formulation one (Annex III).
- Four hair dye ingredientsare added with maximum concentrations and labelling requirements: HC Blue No 18, HC Red No 18, HC Yellow No 16, and Hydroxypropyl-p-phenylenediamine and its dihydrochloride salt. For oxidative products the maxima apply to the concentration after mixing, so the declared figure must be derived from the mixing ratio, not from the tint base alone (Annex III).
- Silver zinc zeolite(Ammonium Silver Zinc Aluminium Silicate) ceases to be prohibited outright. It is now authorised as a preservative at up to 1% in deodorant sprays and powder foundations, with a silver content not exceeding 2.5% (Annexes II and V).
- DHHBa UV filter, retains its 10% maximum but acquires a limit of 10 ppm on the unavoidable trace impurity di-n-hexyl phthalate (DnHexP) (Annex VI). This is a specification requirement, not a formulation one: compliance is demonstrated through the raw material certificate, not the recipe.
Regulation (EU) 2026/78 (applicable since 1 May 2026)
- Fifteen newly classified CMR substancesare added to Annex II, among them acetone oxime, fenpropidin, S-metolachlor, pyraclostrobin, trimethyl borate and multi-walled carbon tubes. The three perborate entries are consolidated into a single entry covering perboric acid and its salts.
- Silveris reorganised by particle size. Nano silver (1–100 nm) and massive silver (1 mm and above) are prohibited. Silver powder (100 nm to 1 mm) is permitted at up to 0.05% in toothpaste and mouthwash, and is authorised as a colorant in that form only, at up to 0.2% in lip products and eye shadow (Annexes II, III and IV).
- Hexyl Salicylatereceives maximum concentrations across six product categories, from 0.001% in toothpaste and mouthwash to 2% in hydroalcoholic fragrances, together with the warning "Not to be used in preparations for children under 3 years of age" subject to defined exceptions — a restriction that intersects with the Article 10(1) duty to assess products for that age group specifically.
- Biphenyl-2-ol (o-phenylphenol)and its sodium salt receive revised preservative limits, expressed as phenol: 0.2% in rinse-off and 0.15% in leave-on products, with the combined total of both salts counting against those limits, and a warning against applications that may expose the lungs by inhalation (Annex V).
Which products are affected
An annex amendment is only material where the substance is present in the formulation. These are the product types most likely to be caught.
| Product type | Substances to screen | Regulation |
|---|---|---|
| Deodorants and antiperspirants | Aluminium-containing ingredients, Citral, Benzyl Salicylate, silver zinc zeolite as a preservative | 2026/909 |
| Fragrances and perfumes | Benzyl Salicylate, Citral, Acetylated Vetiver Oil, Hexyl Salicylate | 2026/909, 2026/78 |
| Hair dyes | HC Blue No 18, HC Red No 18, HC Yellow No 16, Hydroxypropyl-p-phenylenediamine | 2026/909 |
| Toothpaste and mouthwash | Water-soluble zinc salts, aluminium-containing ingredients, silver powder, Hexyl Salicylate | 2026/909, 2026/78 |
| Lip, eye and face make-up | Aluminium-containing ingredients, Citral, Benzyl Salicylate, silver as a colorant | 2026/909, 2026/78 |
| Sun protection products | DHHB (impurity limit) | 2026/909 |
| Leave-on and rinse-off skin and hair care | Citral, Benzyl Salicylate, aluminium-containing ingredients, Hexyl Salicylate, o-phenylphenol as a preservative | 2026/909, 2026/78 |
| Anogenital wipes, including baby wipes | Citral | 2026/909 |
| Any product | Triphenyl Phosphate and the newly prohibited substances | 2026/909, 2026/78 |
What you need to do
- Screen your formulations now.Compare every quantitative composition against the substances above — at use concentration and by product type, since most of these restrictions are conditional on both. Begin with hair dyes, deodorants, fragrances and oral care, where the majority of the changes sit.
- Work back from 1 January 2027.From that date, products not complying with the 2026/909 provisions subject to a transition period may no longer be placed on the EU market. Reformulation, stability and preservative efficacy retesting, and a revised assessment all have to be completed before it — which means starting considerably earlier than the date itself suggests.
- Note the second date.Products already placed on the market may remain available until 1 July 2028, and until 1 August 2028 for the Citral isomers.
- Do not wait on the hair dye and preservative provisions.These apply without a transition period.
- Revise the safety assessment.A changed limit or new condition alters the exposure basis of the CPSR. Part B must be reconsidered and re-signed where the conclusion is affected, and the PIF reissued as a new version.
- Review the labelling.Citral and Benzyl Salicylate must be declared above 0.001% in leave-on and 0.01% in rinse-off products, and the new hair dye entries carry their own warnings and mixing-ratio labelling requirements under Article 19.
- Go back to your suppliers.Obtain confirmation on the certificate of analysis that DnHexP in your DHHB does not exceed 10 ppm, and that Acetylated Vetiver Oil is stabilised with 1% alpha-tocopherol at raw material level. These are specification questions that cannot be answered from the formulation alone, and raw material documentation is usually the longest lead item.
- Confirm Regulation 2026/78 is already closed out.It has applied since 1 May 2026, so the silver, Hexyl Salicylate and o-phenylphenol positions should already be in order. If they are not, the products concerned are non-compliant now, not in 2027.
The concentration figures above are summarised from the consolidated entries and are given for orientation. Before acting on any single limit, verify it against the entry as published in the Official Journal: Regulation (EU) 2026/909 and Regulation (EU) 2026/78.