EU Regulation 2026/909: what does it mean for cosmetic manufacturers?

EU Omnibus VI Regulation (EU) 2026/909: New Restrictions for 12 Cosmetic Ingredients

Commission Regulation (EU) 2026/909 of 27 April 2026 introduces important changes to the annexes of the EU Cosmetics Regulation 1223/2009. The update covers 12 cosmetic ingredients or groups of ingredients, including fragrance substances, UV filters, oral care ingredients, hair dye substances and selected metal compounds. You can review the full legal text in the official EUR-Lex publication of Commission Regulation (EU) 2026/909.

For manufacturers, importers and Responsible Persons, this is not just a technical legislative update. In practice, cosmetic companies need to review product portfolios, check raw material documentation, recalculate concentration limits where necessary, and update Product Information Files and Cosmetic Product Safety Reports when the changes affect product compliance.

As a result, companies should treat the new requirements as part of regular ingredient compliance monitoring in the European Union. Brands that react only when a restriction or prohibition starts applying may face costly reformulations, blocked sales, excess stock and the risk of products being challenged by market surveillance authorities.

If a company sells cosmetic products in the EU, UK or USA, regular ingredient review should form part of a wider cosmetic ingredient compliance system.

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1. Why is Regulation 2026/909 important?

Ingredient rules in the EU regularly change in response to new scientific data, SCCS opinions and chemical classifications. Therefore, an ingredient that a brand uses lawfully today may later receive new restrictions, additional conditions of use or inclusion in the list of prohibited substances.

From a business perspective, the key issue is not only the wording of the new law. The real question is whether the company can translate a regulatory change into operational decisions quickly and accurately.

The practical questions brands need to answer

In practice, cosmetic companies should answer the following questions:

• Does the substance appear in the product portfolio?
• In which product category does the company use it?
• Does its concentration comply with the new limits?
• Does the limit require recalculation based on the content of an element, such as zinc or aluminium?
• Does the formula need reformulation?
• Do the PIF and CPSR still reflect the current regulatory status of the product?
• Can the company continue to sell existing stock during the transition period?

A cosmetic product can become non-compliant even if the formula itself has not changed. This may happen when the legal status of an ingredient changes, when a concentration limit is amended, when conditions of use change or when labelling requirements are updated. For this reason, a CPSR should not be treated as a one-time guarantee of permanent ingredient compliance. See also our article on why “CPSR approved” does not mean your ingredients are compliant in 2026.

2. The 12 ingredients covered by the changes

Portfolio audit starting point

The table below summarises the main ingredients and ingredient groups affected by Regulation (EU) 2026/909. Brands can use it as a practical starting point for a portfolio audit.

This table is a practical editorial guide. It does not replace a product-specific regulatory review of the applicable annex entries.

Why ingredient identification matters

In addition, brands should verify INCI status, CAS/EC numbers and current conditions of use in the official European Commission CosIng database.

Accurate identification matters because the same commercial ingredient name may cover different chemical forms, functions or supplier specifications. Therefore, regulatory teams should not rely only on marketing names or simplified raw material descriptions.

3. Impact on sunscreens, antiperspirants and oral care products

Not all ingredients covered by Regulation 2026/909 create the same business impact. In some product categories, the change may only require confirmation of the ingredient level in the formula. In others, it may trigger reformulation, a change of raw material supplier or an update of the safety documentation.

Three product groups require particular attention: sunscreens, aluminium-containing products and oral care products.

Sunscreens and DHHB

DHHB, or Diethylamino Hydroxybenzoyl Hexyl Benzoate, is an important UVA filter used in sun protection products. For this reason, any change to its status or conditions of use has direct relevance for the sun care segment.

Manufacturers should check not only the concentration of DHHB in the finished product, but also the safety report, raw material declarations, UVA protection justification and Product Information File.

Aluminium and aluminium-containing products

Changes concerning aluminium may affect antiperspirants, colour cosmetics, lip products, nail products and selected aerosol formats. For this group of ingredients, checking the INCI name alone is not enough.

R&D and regulatory teams should establish:

• which aluminium compound the product contains,
• what function the compound performs in the product,
• whether the specific form falls within any exclusions provided in the annexes,
• what level of aluminium appears in the finished product,
• whether the limit refers to the chemical compound or to aluminium as an element.

Zinc salts and oral care products

Water-soluble zinc salts require particular attention in oral care products because users may partially swallow these products. This is especially relevant for toothpastes, mouthwashes and products intended for children.

It is important that brands calculate limits as zinc, not simply as the total mass of the zinc salt. This means that the formulation team needs to recalculate the formula based on the specific chemical form of the zinc salt and the actual zinc ion content. SCCS Opinion SCCS/1657/23 addresses the safety of water-soluble zinc salts used in oral hygiene products, including toothpastes and mouthwashes. The opinion is available on the European Commission website.

4. Limits for water-soluble zinc salts

How to read the zinc limits

For zinc salts such as Zinc Acetate, Zinc Chloride, Zinc Gluconate, Zinc Glutamate, Zinc Citrate and Zinc Sulphate, cumulative exposure to zinc is a key consideration.

The table below can serve as a practical control point for R&D and regulatory teams.

For manufacturers, this means that raw material documentation needs careful review. For example, a formula that contains Zinc Gluconate or Zinc Citrate below 1% does not automatically comply. The company must establish the actual zinc content in the finished product.

5. Transition deadlines: when must products comply?

The two-stage transition period

Regulation (EU) 2026/909 provides transition periods to reduce sudden disruption to sales and help companies manage stock.

The key dates are:

• 18 May 2026 – the date from which the regulation enters into force / starts applying.
• 1 January 2027 – the date from which companies should no longer place non-compliant products on the EU market for the first time.
• 1 July 2028 – the date from which companies should no longer make non-compliant products available on the market.

In practice, the difference between “placing on the market” and “making available on the market” is very important. The first concept refers to the first making available of a product on the EU market. The second covers further supply of the product in the distribution chain, for example sales by distributors, wholesalers and retailers.

The longer period for “making available” gives companies more time to manage stock rotation. However, this does not mean that action can wait. Brands should identify products requiring reformulation, documentation updates or labelling changes as early as possible.

6. What should manufacturers do now?

Regulation 2026/909 requires a systematic approach. The greatest risk is not a single ingredient, but the absence of a complete portfolio review and the lack of connection between formulation data, raw material documentation, PIF, CPSR and sales planning.

1. Audit product formulas

The first step is to check the entire product portfolio for the presence of any of the 12 ingredients or ingredient groups covered by the changes.

The audit should include:

• finished products,
• products in R&D,
• private label products,
• imported products,
• products intended for the EU market,
• products stored before further distribution.

Brands should prioritise oral care products, children’s products, sunscreens, antiperspirants, colour cosmetics and hair dye products.

At this stage, it is useful to carry out an ingredient risk assessment, meaning a practical assessment of ingredient risk before reformulation or documentation updates.

2. Review raw material documentation

In many cases, the INCI name is not enough to confirm compliance. Regulatory teams may need to check technical specifications, certificates of analysis, supplier declarations, active substance levels, impurities and the chemical form of the ingredient.

This is particularly important for ingredients containing zinc or aluminium, as the limits may require recalculation based on elemental content.

3. Recalculate concentrations in the finished product

For zinc salts and aluminium compounds, companies need to confirm that calculations are correct. Different salts of the same element may have different elemental content, so regulatory teams cannot automatically transfer a limit from one raw material to another.

A calculation error may create a situation where the product appears compliant at formula level but exceeds the limit when recalculated as zinc or aluminium.

4. Assess whether reformulation is required

If a product exceeds a new limit or contains a substance that becomes prohibited, the brand may need a new formula. Reformulation should take into account not only the replacement of one ingredient, but also product stability, performance, packaging compatibility, safety assessment and possible new testing.

For UV filters, hair dye substances and fragrance ingredients, changing one component may affect the entire product profile.

5. Update the PIF and CPSR

Any change to the formula or the conditions of use of an ingredient should appear in the product documentation. This applies in particular to the Product Information File and the Cosmetic Product Safety Report.

The documentation should demonstrate that the product complies with current legal requirements and remains safe under normal and reasonably foreseeable conditions of use.

If the change affects composition, safety assessment, ingredient status, labelling or conditions of use, the Responsible Person should check and update the Product Information File where necessary.

In addition, brands placing products on the EU and UK markets should review the Cosmetic Product Safety Report to confirm whether it needs an update or reassessment.

6. Plan stock management

Companies should identify which products can continue to sell during the transition period and which products require earlier withdrawal, reformulation or labelling changes.

It is useful to prepare a SKU list divided into three groups:

• products compliant with the new requirements,
• products requiring confirmation of compliance,
• products requiring action before the relevant deadline.

This approach reduces the risk of lost stock, blocked sales and disposal costs.

7. Risks for companies that do not act in time

Failure to implement the changes introduced by Regulation 2026/909 may create several types of risk.

First, a product may no longer comply with current legal requirements, even if it complied when the brand originally placed it on the market.

Second, distributors and sales platforms may request confirmation of compliance before continuing to sell the product.

Third, market surveillance authorities may challenge the product, documentation or labelling if they do not reflect the current regulatory status of the ingredients.

Fourth, a delayed response may force reformulation under time pressure, increasing costs and the risk of errors.

In practice, the person or entity responsible for ongoing regulatory oversight of the product should monitor this area. Learn more about Annel’s Responsible Person services.

Checklist for cosmetic manufacturers

Key actions before the transition deadlines

Before the full effects of Regulation 2026/909 apply, the manufacturer or Responsible Person should:

• check whether the portfolio contains any of the 12 ingredients covered by the changes,
• review all oral care products containing zinc salts,
• check sunscreens and SPF cosmetics containing DHHB,
• review antiperspirants, colour cosmetics and products containing aluminium,
• check fragranced products containing Benzyl Salicylate, Citral or Acetylated Vetiver Oil,
• review hair dye products containing HC Blue No. 18, HC Red No. 18, HC Yellow No. 16 or Hydroxypropyl-p-Phenylenediamine,
• confirm the status of Triphenyl Phosphate in formulas and raw materials,
• recalculate zinc and aluminium limits according to elemental content requirements,
• update the PIF and CPSR where the product requires a change or reassessment,
• prepare a sales, reformulation or withdrawal plan before the relevant deadlines.

Conclusion

EU Omnibus VI Regulation (EU) 2026/909 is an important regulatory update for the cosmetics industry. It covers ingredients used across several product categories, including sunscreens, antiperspirants, oral care products, fragrance compounds and hair dyes.

For cosmetic companies, the priority is to translate the new requirements into concrete actions: formula audits, raw material checks, concentration recalculations, documentation updates and stock management planning.

A proactive approach helps avoid last-minute reformulation costs, distribution issues and the risk of products being challenged by authorities.

Need support with ingredient compliance?

Do your products contain ingredients covered by EU Regulation 2026/909? Annel can support formula reviews, ingredient risk assessment and PIF and CPSR updates in line with the new EU requirements.

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FAQ

What does EU Regulation 2026/909 cover?

EU Regulation 2026/909 amends the annexes to the EU Cosmetics Regulation 1223/2009 and updates the conditions of use for 12 cosmetic ingredients or ingredient groups.

Do all cosmetic products need to be changed?

No. The change applies to products containing the specific ingredients covered by the new restrictions or prohibitions. However, every portfolio should be checked to confirm which products are affected.

Which product categories are most affected?

Particular attention should be paid to sunscreens, oral care products, children’s products, antiperspirants, colour cosmetics, fragranced products and hair dye products.

Are zinc salt limits calculated based on the total mass of the salt?

No. Limits for zinc salts should be calculated as zinc content. This requires accurate recalculation of the formula based on the specific chemical form of the raw material used.

What does the 1 January 2027 deadline mean?

From this date, companies should no longer place products that do not comply with the new requirements on the EU market for the first time.

What does the 1 July 2028 deadline mean?

From this date, companies should no longer make products that do not comply with the new requirements available on the EU market. In practice, brands and distributors should remove affected products from sales channels.

Does the PIF and CPSR need to be updated?

Yes, if the change affects the formula, safety assessment, ingredient status, conditions of use or product compliance. The PIF and CPSR should reflect the current legal status and the actual product formula.

Is Triphenyl Phosphate only restricted?

No. In the context of Regulation 2026/909, Triphenyl Phosphate should be treated as an ingredient subject to prohibition through its inclusion in Annex II, the list of substances prohibited in cosmetic products.

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Need to check whether Regulation 2026/909 affects your products?

If your cosmetic products contain any of the ingredients covered by EU Omnibus VI Regulation (EU) 2026/909, the safest next step is to review the formula, raw material documentation, PIF and CPSR before the transition deadlines apply.

Annel can support cosmetic brands with ingredient compliance checks, formula risk assessment, PIF review and CPSR updates for products placed on the EU and UK markets.

Therefore, if your portfolio includes sunscreens, oral care products, antiperspirants, colour cosmetics, fragrance products or hair dyes, early review can help reduce reformulation risk and avoid last-minute compliance pressure.