法規更新

Cosmetics Regulation (EU) 2026/909 Introduces New Restrictions, Prohibitions and Ingredient Conditions

2026.05.21

The European Commission has adopted Commission Regulation (EU) 2026/909, published on 28 April 2026, amending Annexes II, III, V and VI of Regulation (EC) No 1223/2009 on cosmetic products.

The amendment introduces new prohibitions, revised concentration limits, reclassifications, and impurity controls for a wide range of cosmetic ingredients, reflecting updated scientific evaluations by the Scientific Committee on Consumer Safety (SCCS).

The Regulation enters into force on 18 May 2026, with transitional compliance deadlines extending into 2027 and 2028.

Key changes are highlighted in this article. For detailed requirement, please refer to the original Commission Regulation (EU) 2026/909.

 

What are the key changes:

 

1.   New Prohibition: Triphenyl Phosphate

Triphenyl Phosphate has been added to Annex II (prohibited substances) due to unresolved safety concerns, including insufficient data to rule out genotoxicity.

·         Regulatory impact:

o    Ban applies to all cosmetic products

 

2.   Expanded Restrictions Across Multiple Ingredient Categories

a.    Fragrance Allergens

Benzyl Salicylate and Citral (including Geranial and Neral) are subject to revised concentration limits based on updated risk assessments.

·         New maximum concentration thresholds vary by product type (e.g. leave on, rinse-off, oral, deodorants)

·         Existing labelling trigger thresholds remain:

o    0.001% (leave-on)

o    0.01% (rinse-off)

 

b.    Aluminium-Containing Ingredients

A comprehensive new entry (Annex III/379) introduces product-specific maximum concentration limits for aluminium compounds across multiple cosmetic categories.

·         Includes antiperspirants, toothpaste, make-up, hair products, and leave-on formulations

·         Addresses systemic exposure concerns identified in SCCS evaluation

 

c.    Water-Soluble Zinc Salts

Updated restrictions introduce age- and product-specific limits, particularly for oral care products.

·         Toothpaste:

o    1% as zinc (above 1 year of age)

o    0.72% as zinc (for children 6–12 months)

·         Mouthwash:

o    0.1% as zinc (for users above 6 years)

·         Others:

o    1% as zinc

 

d.    Acetylated Vetiver Oil

A new Annex III entry establishes maximum concentration limits across product types, with an additional requirement:

·         Raw material must be stabilized with 1% alpha-tocopherol

 

e.    Hair Dye Ingredients

Several hair dye substances are newly regulated with strict maximum concentrations and mandatory warning labelling:

·         HC Blue No 18:

o    0.35% (oxidative hair dye products, after mixing)

o    0.35% (non-oxidative hair dye products)

·         HC Yellow No 16:

o    1% (oxidative hair dye products, after mixing)

o    1.5% (non-oxidative hair dye products)

·         HC Red No 18:

o    1.5% (oxidative hair dye products, after mixing)

o    0.5% (non-oxidative)

·         Hydroxypropyl‑p‑phenylenediamine and its 2HCl salt: up to 2%

These measures align with SCCS safety evaluations addressing sensitisation risks and consumer exposure.

 

3.   Reclassification of Silver Zinc Zeolite

Silver zinc zeolite (INCI: Ammonium Silver Zinc Aluminium Silicate) undergoes a regulatory reclassification:

·         Removed from Annex II (prohibited substances)

·         Added to Annex V (approved preservatives) with conditions

Conditions of use:

·         Maximum concentration: 1%

·         Applicable to:

o    Deodorant sprays

o    Powder foundations

·         Silver content must not exceed 2.5%

This reflects SCCS confirmation of safe use under controlled conditions.

 

4.   Impurity Limit for UV Filter (DHHB)

The UV filter Diethylamino Hydroxybenzoyl Hexyl Benzoate (DHHB) remains permitted but is now subject to a strict impurity limit:

·         Di-n-hexyl phthalate (DnHexP), as an unavoiable trace impurity, must not exceed 10 ppm

This decision balances safety concerns with manufacturing feasibility, particularly for sunscreen formulations.

 

What are the compliance timeline and transitional period:

To enable industry adaptation, phased compliance deadlines apply:

General substances (e.g. Triphenyl Phosphate, Benzyl Salicylate, aluminium, zinc salts, DHHB):

  • 1 January 2027: Products placed on the market must comply
  • 1 July 2028: Products must no longer be available on the market if non-compliant

Specific fragrance components (Geranial, Neral):

  • 1 January 2027: Products placed on the market must comply
  • 1 August 2028: Products must no longer be available on the market if non-compliant

Hair dye substances and Silver zinc zeolite as preservative:

  • 18 May 2026 (no transitional period)

 

What you should do

This amendment represents a multi-layered regulatory update with significant implications for cosmetic manufacturers:

  • Check raw material specifications (e.g. DHHB impurity control, vetiver oil stabilization)
  • Reformulate when necessary
  • Updated labelling obligations for allergens and hair dyes
  • Evaluate the possibility for ingredient substitution

 

 

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