September monthly roundup

EU

Microplastics Regulation: Draft Amendment Clarifies Exemptions

On 17 September 2025, the European Commission published a draft amendment to the Microplastics Regulation (EU 2023/2055). This amendment aims to clarify ambiguities in entry 78 of REACH Annex XVII, following feedback from Member States and stakeholders.

Key clarifications:

• Medicinal products: All human and veterinary medicines, including those in clinical trials, are exempt.
• Research & development: A new derogation allows use of synthetic polymer microparticles in R&D up to 1 tonne per year.
• Permanent incorporation: Only microplastics embedded in solid matrices intended to last ≥1 year are exempt — short-use items, such as peel-off films or temporary coatings, will not qualify.

Timeline: Consultation runs until 16 November 2025. Adoption is expected in Q4 2025, with the medicinal exemption applied retroactively from 17 October 2023.

For cosmetics, this does not loosen the ban but provides greater clarity and ensures innovation space for laboratories. Companies using encapsulated actives, exfoliating beads, film-formers, or glitter should review formulations and compliance strategies immediately.

Spain Drafts Royal Decree on Accessible Labelling

On 15 September 2025, Spain notified a draft Royal Decree that will introduce accessible labelling requirements for consumer products, including cosmetics. The measure is designed to enhance inclusivity and improve consumer safety for individuals with disabilities, particularly those with visual impairments.

• Scope: Applies to all consumer products marketed in Spain, including cosmetics, across all sales channels.
• Exemptions: Professional-use only products, bulk sales, or unpackaged goods.
• Accessible formats: Labels must present information in formats accessible to all — e.g. Braille, QR codes with tactile locators, or equivalent technologies. All mandatory information must appear in Castilian Spanish.
• Timeline: Consultation open until 17 November 2025. Final adoption expected in December 2025, with a two-year transition period for products already on the market. After that, supplementary stickers or print solutions will be required for non-compliant stock.

This is a landmark step for inclusive cosmetics. Brands should start preparing packaging updates, digital strategies, and content governance to ensure compliance within the transition period.

PFAS and Octocrylene: ECHA Committees Advance Key Dossiers

At their September 2025 meetings, ECHA’s Risk Assessment Committee (RAC) and Socio-Economic Analysis Committee (SEAC) made progress on two significant restriction proposals under REACH.

• Octocrylene: France submitted a restriction dossier in July proposing to ban finished cosmetic products containing Octocrylene at levels ≥0.001% w/w. This is a dramatic reduction compared to the current authorizations of 9% (aerosols) and 10% (other cosmetics). The dossier has been validated, and ECHA launched a six-month public consultation (September 24, 2025 – March 24, 2026). If adopted, the restriction will take effect 24 months after entry into force, giving brands a limited time to reformulate.
• PFAS: RAC and SEAC advanced their work on the EU-wide proposal to restrict PFAS. RAC issued provisional conclusions on uses in electronics and semiconductors, while SEAC did the same for energy and lubricants. Both committees also began discussions on manufacturing processes and broader regulatory issues such as threshold values, risk assessments, and measures to limit emissions.

Timeline: RAC’s final opinion is due in March 2026, with SEAC’s draft opinion consulted in parallel. Both committees’ final opinions are expected by the end of 2026, when ECHA will forward them to the Commission. Companies using Octocrylene or PFAS should not wait — review your product portfolios and identify substitution strategies now.

Borderline Manual v5.5 — New Clarifications

The European Commission has released Version 5.5 of the Borderline Manual, updating product classification guidance with three new entries:

• Self-tanning concentrates: Confirmed as cosmetics when mixed by consumers with lotions or creams. Safety files must also consider the mixtures created.
• Oral drops, sprays, gels: Generally, not cosmetics, unless spat out and free of ingredients with systemic pharmacological effects. Classification depends on presentation and instructions.
• Henna contour paste: Confirmed as a cosmetic product, since it is applied externally to protect skin during henna application.

Although not legally binding, the Manual is a widely used reference by EU authorities. Brands should align claims, instructions, and safety assessments with these clarifications to avoid misclassification.

USA

FDA Launches Public Dashboard for Cosmetic Adverse Events

On September 12, 2025, the U.S. FDA introduced its FAERS Public Dashboard for Cosmetics, an online tool providing the public with real-time access to adverse event reports dating back to 2001.

The dashboard includes:

• Mandatory submissions required under MoCRA,
• Voluntary reports from companies, professionals, and consumers.

Users can filter by brand, product type, event severity, or date, and download datasets for analysis. The FDA emphasizes that reports are not verified and do not establish causality, indicating that the data should be viewed as signals rather than confirmed safety issues.

Why it matters: This move enhances transparency but also increases visibility of complaints. For companies, it is both a compliance tool for safety monitoring and a reputational risk if reports linked to their products appear without full context.

Washington State Expands Ban to 25 Formaldehyde Releasers

On 28 August 2025, the Washington State Department of Ecology announced the adoption of Chapter 173-339 WAC: Cosmetic Products Restrictions, significantly expanding the scope of the Toxic-Free Cosmetics Act (TFCA).

This new regulation bans 25 formaldehyde-releasing substances in cosmetics, marking one of the strictest preservative-related restrictions in the U.S.

Key details

• Effective date: The ban takes effect on 1 January 2027.
• Sell-through period: Non-compliant products already on the market may continue to be sold until 31 December 2027.
• Scope of prohibition: Applies to intentional use of formaldehyde releasers in any cosmetic product sold in Washington State.

Substances included

The ban targets widely used preservatives and raw materials known to release formaldehyde over time. The list covers DMDM Hydantoin, Diazolidinyl Urea, Bronopol, Quaternium-15, Methenamine, and a variety of polymers not currently regulated under EU legislation. Some of these substances still have permitted uses in the EU at restricted concentrations, while others are already prohibited.

Implications for industry

This rule aligns with Washington’s broader strategy under the TFCA, which already bans substances such as lead, mercury, triclosan, methylene glycol, and PFAS in cosmetics. By extending the ban to formaldehyde releasers, Washington has positioned itself as a pioneer in state-level cosmetic safety legislation.

For companies, the practical impacts include:

• Raw material audits: All formulations destined for sale in Washington must be screened for any of the 25 listed substances.
• Reformulation planning: Preservatives will need to be substituted with compliant alternatives well before the 2027 deadline.
• Dual compliance strategies: Brands operating in both the EU and U.S. must now manage differences, since some formaldehyde releasers remain permitted at restricted levels in the EU but are fully banned in Washington.

Action point: Begin reformulation work early. Although the law allows for a transition period until the end of 2027, last-minute changes could disrupt supply chains and increase costs.

UAE

Dubai Municipality Orders Immediate Recall of Cannabis-Derived Consumer Products

On 15 September 2025, Dubai Municipality announced an immediate recall of all consumer products containing cannabis or its derivatives. This applies to all forms and sources, including:

• Cannabidiol (CBD),
• Tetrahydrocannabinol (THC),
• Hemp seed oil,
• Hemp extract, or
• Any other substance derived from the cannabis plant.

The measure applies regardless of THC levels (including 0% or not detected) and whether the ingredient is natural or synthetic.

Obligations for distributors, suppliers, and retailers:

1. Cease sales and imports immediately of affected products.
2. Report all inventory quantities and coordinate with Dubai Municipality inspection teams within 2 working days.
3. Re-export or destroy recalled stock in compliance with regulations and submit proof of disposal.

Dubai Municipality emphasized that the decision is in line with UAE laws and regulations. Businesses that fail to comply will face severe fines and penalties.

For queries, the Municipality has provided a 24/7 helpline (800900) and an official contact email.

This recall underscores the UAE’s zero-tolerance policy toward cannabis-related ingredients in consumer goods, including cosmetics. Companies operating in the region must carefully audit product formulations and supply chains to avoid compliance risks.