June Regulatory Roundup

EU News

Homosalate Restrictions Updated in EU—Effective July 1st

Homosalate is a UV filter, with CAS 118-56-9 and EINECS / Elincs no: 204-26-08, with a new maximum restriction level of 7.34% allowed in face products, applicable to products on sale in Europe, from 1st July this year. This follows the SCCS opinion published in 2021. All face products with levels above 7.34% should be removed from the market by July 1st.

The above restriction level does not apply to products on sale in Great Britain, where a 10% limit is still permitted in all cosmetic products, following the opinion published by the SAGCS.

EU Classification Labelling Packaging (CLP) Regulation update

The EU Commission published the 23rd Adaptation to Technical Progress (ATP) on 20th June. The legislation amends Annex VI of the EU CLP to achieve greater harmonization of chemical classification and comes into force 20 days after publication (mid-July), effective from 1 February 2027.

The update to Annex VI includes new Carcinogenic Mutagenic and Reprotoxic (CMR) classifications.

These include

OzoneCAS 100028-15-6 To be added to Annex II of EU Cosmetic Product Regulation (CPR)
Nitrous OxideCAS 10024-97-2As above
CI Pigment Red 53CAS 5160-02-1Already included in Annex II of EU CPR
Tetrahydrofurfuryl-methacrylateCAS 2455-24-5(CMR 1B)To be added to Annex II of EU CPR
CaptanCAS 133-06-2 (CRM 2)Already included in Annex II of EU CPR

Note: The 23rd ATP to CLP does not currently apply to GB CLP Regulations and may be further evaluated.

SCCS Draft Opinion Sets Tea Tree Oil Limits in Cosmetics

The European Scientific Committee have been recently reviewing the safety of Tea Tree oil (CAS / EC 68647-73-4 / 285-377-1) and its use in cosmetic products as an anti-seborrheic and anti-microbial agent and has concluded on the following draft opinion with maximum concentrations:

  • 2.0% in shampoo,
  • 1.0% in shower gel,
  • 1.0% in face wash
  • 0.1% in face cream.

This draft opinion is open for comments until August 18th this year, where tea tree oil’s chemical composition conforms to the updated International Standard (ISO 4730:2017) in cosmetic products.

France Seeks CLH Classification of Methylparaben as an Endocrine Disruptor

On 18 June 2025France notified the European Chemicals Agency (ECHA) of its intention to propose a harmonised classification and labelling (CLH) for Methylparaben (CAS 99-76-3, INCI: Methylparaben) as:

  • ED ENV 1 (EUH430): May cause endocrine disruption in the environment
  • Endocrine disruptor for human health

🔍 Current status: Methylparaben is regulated under Annex V/12 of the Cosmetics Regulation:

  • Max 0.4% (when used alone)
  • Max 0.8% (in mixtures)

In its 2024 review, the SCCS confirmed that these concentrations are safe for human use. However, the new French CLH proposal could pave the way for broader regulatory consequences under the CLP Regulation and future REACH restrictions.

Brands using Methylparaben should monitor ECHA proceedings and begin exploring alternatives, especially for eco-conscious and endocrine-sensitive product lines.

Prostaglandin Analogues: SCCS Declares Lash-Growth Actives Unsafe

A long-awaited preliminary Opinion has been released by the Scientific Committee on Consumer Safety (SCCS)regarding three prostaglandin analogues frequently used in eyelash and eyebrow enhancement products:

  • Isopropyl Cloprostenate
  • Ethyl Tafluprostamide
  • Methylamido-Dihydro-Noralfaprostal (MDN)

In its 2022 review, the SCCS was unable to draw a conclusion due to limited data. However, following the industry’s new submissions in 2024, the committee has now concluded that none of these substances can be considered safe, even at low concentrations.

 Why?

  • These substances exhibit strong pharmacological effects, even at minimal concentrations.
  • There is a lack of data ruling out reproductive/developmental toxicity, which is especially concerning considering the target user group—young women.

The draft opinion is open for comment until 18 August 2025.

Next steps for brands using these compounds in lash/brow products: prepare for possible restrictions or reformulation, depending on the final SCCS opinion later this year.

EU Bans 21 Additional Substances in Cosmetics – Regulation (EU) 2025/877

On 1 September 2025, the EU will ban 21 substances from all cosmetic products under Regulation (EU) 2025/877, in alignment with CMR (Carcinogenic, Mutagenic, or Reprotoxic) classification.

Key banned ingredients include:

  • Trimethylbenzoyl Diphenylphosphine Oxide (used in nail products)
  • Tetrabromobisphenol A (TBBPA) & Bisphenol AF (known endocrine disruptors)
  • Clothianidin (a neonicotinoid pesticide)
  • Multiple aromatic amines

No grace period: Products containing any of these substances must be entirely removed from the EU market by 1 September 2025, whether placed or made available.

Action point for industry: Conduct thorough INCI audits, reformulate products as necessary, and update safety assessments to maintain market access.

USA News

Safe Sunscreen Standards Act

Bill HR 3686 has been introduced Jun 3, 2025 into Pennsylvania state, requesting that the Federal Food, Drug and Cosmetic Act review process, be amended for sunscreen active ingredients, for non-prescription purpose, since the number of skin cancer continues to increase in the USA, with skin cancer now identified as the most common cancer in the USA.

The basis of this bill requesting FDA to provide a more streamlined regulatory approval process whilst still ensuring that robust scientific and testing paraments are in place to protect consumer safety, since no new sunscreen actives have been approved since 1999, the request to allow non-animal test data, could help speed up the regulatory approval process.