July Regulatory Roundup

EU News

Regulatory Update – EU Proposes Major Changes for 12 Cosmetic Ingredients

On July 16, 2025, the European Commission notified a draft Regulation that would amend several annexes of the EU Cosmetics Regulation (EC) No 1223/2009. This proposal aims to transpose recent SCCS opinions into binding law and introduces bans and restrictions for 12 cosmetic ingredients.

Open for public comments until September 14, 2025. The regulation is expected to be adopted in Q1 2026 and come into force on January 1, 2027.

What’s changing?

❌ Banned:

• Triphenyl Phosphate – Added to Annex II (prohibited substances) due to potential genotoxicity.

✅ Reintroduced as a safe preservative:

• Ammonium Silver Zinc Aluminum Silicate (Silver zinc zeolite): Added to Annex V with specific max concentrations.

⚠️ Restricted Use Now Applies To:

➤ Aluminium-containing ingredients

Used in deodorants, toothpaste, skincare, haircare, and color cosmetics. Now restricted based on product type and Al concentration.

➤ Acetylated Vetiver Oil

Permitted only in low concentrations, stabilized with α-tocopherol.

➤ Hair Dyes – 4 ingredients newly restricted:

• HC Blue 18
• HC Yellow 16
• HC Red 18
• Hydroxypropyl-p-phenylenediamine & 2HCl salt

Labels must include allergy warnings, age limitations, and safety instructions.

➤ Fragrance allergens and functional ingredients:

• Citral: Maximum levels defined across 9 product categories. Labelling required if above threshold.
• Benzyl Salicylate: Limits established for nine types of products, with mandatory ingredient disclosure.
• Water-soluble zinc salts (e.g., zinc gluconate, citrate, acetate): Restricted by product type and concentration.
• DHHB (Diethylamino Hydroxybenzoyl Hexyl Benzoate): Allowed up to 10%, provided impurity DnHexP ≤ 10 ppm.

Timeline to comply

As of January 1, 2027, Non-compliant products cannot be placed on the EU market.

July–Aug 2028 (varies by substance), non-compliant products must be withdrawn from sale.

Next steps for cosmetic brands

• Review formulations and ingredient concentrations.
• Update labelling for affected products (especially hair dyes and allergens).
• Reformulate if needed to meet new maximum allowed limits.
• Monitor adoption of the regulation by early 2026 and prepare for 2027 enforcement.

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Final SCCS Opinion on DHHB and Phthalate Contamination

In July 2025, the SCCS published its final Scientific Advice regarding the UV filter Diethylamino Hydroxybenzoyl Hexyl Benzoate (DHHB), following concerns about contamination with the phthalate DnHexP (Di-n-hexyl phthalate).

Why the Reassessment?

• DHHB is authorised in the EU up to 10% (Annex VI/28).
• In 2024, German authorities detected MnHexP (a DnHexP metabolite) in children’s urine, raising concerns about sunscreens as a potential source.
• DnHexP may occur as a residual contaminant during DHHB production.
• In response, the European Commission asked the SCCS to evaluate the safety of DHHB, explicitly considering the presence of DnHexP.

SCCS Final Conclusion

• A maximum safe level of 0.026% (260 ppm) of DnHexP is acceptable in DHHB, only if it is unavoidable.
• Based on manufacturing data, it is technically feasible to reduce DnHexP to 1 ppm or lower.
• The SCCS recommends 1 ppm as a target level to minimize health risks.

What’s Next?

This opinion will guide future regulatory updates to Annex VI, introducing impurity limits for DHHB.

Manufacturers should:

• Check DHHB purity in current formulations,
• Request specifications from suppliers, and
• Prepare for possible compliance changes ahead.

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SCCS Finalises Safety Opinion on Hydroxyapatite (Nano) in Oral Cosmetics

In July 2025, the Scientific Committee on Consumer Safety (SCCS) published its final opinion on the use of Hydroxyapatite (nano) in oral cosmetic products, following additional data submitted by industry to support its safe use at higher concentrations.

Background

• Hydroxyapatite (nano) is commonly used in toothpaste and mouthwash for its enamel-repairing and whitening properties.
• In 2024, the European Commission restricted its use via Regulation (EU) 2024/858, based on earlier SCCS safety concerns.
• The cosmetics industry later submitted new toxicological and biocompatibility data seeking approval for higher use levels.

Final SCCS Conclusion

The SCCS now considers Hydroxyapatite (nano) safe when used:

• Up to 29.5% in toothpaste
• Up to 10% in mouthwash

This conclusion is valid only if the particles meet the following criteria:

• Rod-shaped, with at least 87% having aspect ratios ≤3 (and none exceeding 9)
• Uncoated and not surface-modified
• Maximum length: ~122 ± 43 nm

The SCCS also confirmed:

• No mutagenicity, cytotoxicity, or inflammation was observed in cell models.
• Particle uptake in the oral mucosa is minimal, and any internalised cells are naturally shed.
• Ingested particles are expected to dissolve rapidly in gastric fluid, posing no nano-specific safety concerns.

Notable Limitation

The opinion does not apply to Hydroxyapatite composed of or containing needle-shaped particles, which are excluded due to potential safety risks.

What’s Next?

This updated opinion supports continued use of Hydroxyapatite in oral care, provided strict particle specifications are met. Brands formulating toothpaste or mouthwash with HAP (nano) should ensure supplier compliance, verify particle morphology, and stay informed about upcoming regulatory updates.

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CS Publishes Final Opinions on Benzophenone-2, Benzophenone-5 & Ethylhexyl Methoxycinnamate

As part of the EU’s priority assessment of potential endocrine disruptors in cosmetics, the SCCS has published its final safety opinions on three UV filters: Benzophenone-2 (BP-2), Benzophenone-5 (BP-5), and Ethylhexyl Methoxycinnamate (EHMC).

Benzophenone-2 (BP-2): Safety Not Confirmed

• Status: Not currently regulated under Regulation (EC) 1223/2009
• Conclusion: The SCCS could not confirm the safety of BP-2 in cosmetics.

• Why?
• Evidence shows estrogenic activity (endocrine disruption)
• Possible genotoxicity
• Lack of data on repeated dose and reproductive toxicity

• Therefore, the use of BP-2 may pose a risk to consumers, and SCCS does not support its inclusion in cosmetics.

Benzophenone-5 (BP-5): Safe at Current Limits

• Status: Authorised UV filter under Annex VI/22, up to 5% (as acid)
• Conclusion: SCCS considers BP-5 safe at 5%, based on read-across from Benzophenone-4 (its parent compound)
• Safe in:
• Sunscreens
• Face and hand creams
• Lipsticks
• Pump and propellant sprays
• Applies whether used alone or in combination

Ethylhexyl Methoxycinnamate (EHMC): Safe up to 10%

• Status: Regulated under Annex VI/12, up to 10%
• Conclusion: EHMC is safe as a UV filter up to 10%, including in children’s products

• Why?
• Although EHMC shows estrogenic and weak anti-androgenic effects, SCCS determined a high Margin of Safety.
• This offsets concerns about endocrine activity.

• Safe for:
• Sunscreens
• Face/hand creams
• Lipsticks
• Sprays (propellant or pump)

Environmental Considerations

SCCS clarifies that its mandate does not cover environmental safety. While substances like BP-2 are suspected of polluting surface waters, this was not assessed.

What Does This Mean for Brands?

• BP-2: Avoid using unless new safety data becomes available
• BP-5 and EHMC: Continue use within allowed concentrations
• Monitor future regulatory updates based on these SCCS conclusions

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ECHA’s Risk Assessment Committee Proposes EU-Wide Classification for Talc

The European Chemicals Agency’s (ECHA) Committee for Risk Assessment (RAC) has published its opinion proposing a harmonized classification and labelling for talc (Mg₃H₂(SiO₃)₄, CAS No. 14807-96-6).

Talc is widely used across various industries, including:

• Cosmetic-grade talc in body powders and personal care products
• Additives in pharmaceuticals and other manufacturing applications

Proposed Classification

The RAC recommends that talc not containing asbestos or asbestiform fibres be classified at the EU level as follows:

• STOT RE 1; H372 – Causes damage to lungs through prolonged or repeated inhalation exposure
• Carc. 2; H351 – Suspected of causing cancer

Currently, talc is not listed under Annex VI of the CLP Regulation, meaning there is no harmonized EU classification in force.

This proposed classification, once adopted, could significantly impact how talc is used, labelled, and regulated—particularly in cosmetics and personal care products.

USA News

The U.S. House of Representatives passed the Wastewater Infrastructure Pollution Prevention and Environmental Safety Act.

Washington, D.C. —the Wastewater Infrastructure Pollution Prevention and Environmental Safety (WIPPES) Act. – This important legislation reflects a thoughtful approach to addressing the challenges associated with the improper disposal of non-flushable wipes.

If this bill is enacted, it will define federal labelling standards for certain pre-moistened, nonwoven wipes, aligning with existing industry guidelines to ensure proper disposal.

CE.way is continuing to monitor this bill, and the many benefits this framework will provide to consumers, protecting the environment and providing a sustainability framework across the industry.

UK News

Wales Bans Sale of Wet Wipes Containing Plastic

Wales has officially passed a new law banning the sale of wet wipes containing plastic, under the Environmental Protection (Single Use Plastics) Act. This move is part of a broader effort to reduce plastic pollution and protect the environment.

The ban expands on existing restrictions by adding wet wipes to the list of prohibited single-use plastic items, alongside cotton buds, plastic straws, cutlery, and others.

The regulation also covers:

• Pre-wetted sheet masks
• Single-use face masks containing plastic

Effective Date:

The ban will come into force on 18 December 2026. From that date, consumers will no longer be able to purchase wet wipes with plastic content in Wales.

Exemption:

Wet wipes intended for medical care or treatment are exempt from the ban.

Great Britain Sets New Limits on Benzophenone-3 in Cosmetic Products

On 21 July 2025, the UK government published Statutory Instrument 2025 No. 901, titled “The Cosmetic Products (Restriction of Chemical Substances) (No. 2) Regulations 2025.” This amendment to the UK Cosmetics Regulation introduces new restrictions on Benzophenone-3—also known as Oxybenzone—a commonly used UV filter.

These rules apply to cosmetic products sold in England, Wales, and Scotland, and align closely with previously adopted EU restrictions under Regulation (EU) 2022/1176.

Implementation Timeline

• Entry into force: 21 January 2026
• Sell-through period: Products placed on the market before this date can continue to be sold until 21 July 2026.

EU Alignment

These UK restrictions mirror those of EU Regulation (EU) 2022/1176, which became effective:

• 28 January 2023 for market placement
• 28 July 2023 for market availability

Key Takeaway

Brands selling in the UK must review sunscreen and skincare formulas containing Benzophenone-3 to ensure compliance before January 2026, especially regarding labeled concentrations and intended function (UV protection vs. formulation stabilizer).

For support in updating formulas or labels.