EU
Prostaglandin Analogues: Final Opinion of the SCCS
The Scientific Committee on Consumer Safety (SCCS) has published the final Opinion on prostaglandin analogues used in cosmetic products (notably lash and brow serums) on 10 February 2026.
In 2022, SCCS was unable to conclude on safety due to insufficient data. Following new industry submissions, the Committee has now re-evaluated these substances.
The INCIs affected, which will likely be banned for use in cosmetics are:
- Norbimatoprost
- Isopropyl Cloprostenate
- Ethyl Tafluprostamide / Tafluprost
While full regulatory consequences will depend on Commission follow-up, this Opinion is expected to significantly impact:
- Lash growth serum formulations
- Borderline drug/cosmetic positioning
- Ingredient innovation strategies
Basic Blue 99 & Basic Brown 16 – Final SCCS Scientific Advices
SCCS has finalised its Scientific Advices on two hair dye ingredients:
- Basic Blue 99 (C059)
- Basic Brown 16 (C009)
Following mandates accepted in March, the Committee assessed updated safety dossiers submitted by industry. The SCCS concluded these two ingredients are not safe for use in non-oxidative hair dye formulations, in light of the collective evidence pointing to a potential genotoxic concern.
Hair dye ingredients continue to receive heightened scrutiny, particularly regarding:
- Sensitisation potential
- Genotoxicity data
- Margin of safety calculations
The final conclusions will inform possible amendments to Annex III of Regulation (EC) No 1223/2009.
SCCS opinions on CBD and BHA bring long-awaited clarity
In January, the SCCS published two important scientific opinions addressing ingredients of high industry interest.
For Cannabidiol (CBD), the Committee concluded that:
- CBD is safe up to 0.19% in dermal and oral cosmetic products
- THC impurities must not exceed 0.00025%
- The opinion does not apply to products with potential inhalation exposure
For Butylated Hydroxyanisole (BHA), the SCCS concluded that:
- Use up to 0.07% is safe in leave-on and rinse-off products
- The assessment is limited to dermal exposure
- Oral care products and inhalation exposure are excluded
These conclusions reinforce the importance of impurity control, exposure-based safety assessment and careful product classification.
Thiomersal & Phenylmercuric Salts – Final SCCS Opinion
In January 2025, SCCS accepted a mandate to reassess Thiomersal and Phenylmercury salts as preservatives.
The final Opinion has now been published. The conclusion is that they are not considered safe at concentration levels currently permitted in cosmetic products. The opinion will likely result in the exclusion of these ingredients from the allowed preservatives list (Annex V).
INCIs affected:
- Thiomersal
- Phenyl mercuric acetate
- Phenyl mercuric bromide
- Phenyl mercuric benzoate
- Phenyl mercuric borate
- Phenyl mercuric chloride
Given the historical concerns around mercury-containing compounds, this Opinion is particularly relevant for:
- Eye products
- Legacy preservative systems
- Global portfolio harmonisation
UK
Scotland Bans Plastic-Containing Wipes
Scotland has joined England and Wales in banning wipes containing plastic.
As environmental legislation is developed in the UK, each nation adopts its own measures.
Impact areas:
- Cosmetic wipes
- Baby wipes
- Personal hygiene wipes
This reinforces the regulatory intersection between environmental compliance and cosmetic product design.
Talc: Diverging Regulatory Perspectives Between GB and EU
In January 2026, the Health and Safety Executive (HSE) published its technical report on the proposed harmonised classification of talc under the GB Classification, Labelling and Packaging (CLP) Regulation.
GB Position: No CMR Classification Proposed
After reviewing available data, HSE concluded that:
“The Agency does not consider the available data are sufficient to support classification for carcinogenicity.”
As a result:
- No CMR classification is proposed for talc under GB CLP.
- No automatic cosmetic ban is expected in Great Britain.
- Current cosmetic uses remain unaffected at this stage.
This position provides regulatory stability for GB-based manufacturers and brands placing talc-containing cosmetics on the market.
USA
FDA Publishes PFAS Report and Expands Records Access Under MoCRA
At the turn of 2026, the U.S. Food and Drug Administration (FDA) released two key documents directly linked to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), confirming that enforcement implementation is now fully operational.
PFAS in Cosmetics – First Federal Mapping
On 29 December 2025, FDA submitted to Congress its PFAS report based on the first MoCRA product listing submissions.
Key data:
- 51 PFAS intentionally added to cosmetic products
- 1,744 formulations identified
- 25 substances prioritised for toxicological review
- Most lack sufficient safety data
- 5 considered low concern under current conditions
- One substance flagged: perfluorohexylethyl triethoxysilane (body lotion use)
There are currently no federal PFAS bans, but FDA explicitly stated it may consider regulatory action if concerns are confirmed.
MoCRA Update for cosmetic facilities
The FDA had updated the Cosmetics Direct user guide and portal while and rolling out new support materials to simplify the biennial facility registration required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
What’s new?
Automated email reminders have now been set up, to be sent before the renewal deadline, not just to the facility contact, but also to:
- The FDA Direct account contact
- The U.S. agent
- Any additional contacts
- Paper submitters (when applicable)
What actions should brands take?
- Review all registrations
- Verify contact details
- Ensure the U.S. agent information is up to date
MIDDLE EAST
Kuwait Issues Ministerial Decree 344/2025 – EU-Aligned Cosmetic Framework
The Kuwait Ministry of Health has issued Ministerial Decree 344/2025, establishing a comprehensive new framework for cosmetic registration, importation and marketing.
The Decree aligns Kuwait’s framework with:
- Regulation (EC) No 1223/2009
- GSO Standards
Key Regulatory Highlights
Strict Medical Claim Prohibition
Any claim implying treatment, cure, or physiological alteration is prohibited. Products may be rejected or reclassified.
Reclassification Authority
The Ministry may reclassify products during audits if claims or ingredient levels suggest medical positioning.
EU-Aligned Ingredient Restrictions
Adoption of Annex II & III prohibitions, including strict CMR bans.
Mandatory Bilingual Labelling
Arabic and/or English required.
Nano-materials must be clearly declared.
Specific warnings required for tanning products without SPF.
Impact on Aesthetics & MedTech Companies
High reclassification risk for:
- Post-procedure skincare
- Laser cooling gels
- Wound care topicals
- “Healing” positioned serums
Clinical substantiation burden increases for products with “medicated features.”
Recommended Actions
- Conduct claims audit
- Verify ingredient compliance with EU Annexes
- Prepare clinical evidence files
- Coordinate with local authorised representatives
EU PPWR – Key Dates for Legislative Acts
The EU Packaging and Packaging Waste Regulation (PPWR) entered into force on 11 February 2025 and applies from 12 August 2026.
For many of the topics addressed by the PPWR, the European Commission is required to adopt legislative acts. As of now, these legislative acts have not yet been adopted and are still forthcoming.
Particularly important legislative acts expected in 2026, and adopted in either 2028 or 2029 include:
- Harmonised labels (Article 11(1,6)), to be adopted by 12 August 2026 (applicable from 12 August 2028)
- Methodology for calculating the percentage of recycled content (Article 7(8)), to be adopted by 31 December 2026 (applicable from 1 January 2029);
- Recycled content label, which is not mandatory (Article 12(4,6)), to be adopted by 12 August 2026 (applicable from 12 August 2028); and
- Material composition methodology (Article 12(7)), to be adopted by 12 August 2026 (applicable from 12 August 2028).
- Reusable packaging label (Article 12(2,6)), to be adopted by 12 August 2026 (applicable from 12 February 2029);
These upcoming acts are particularly relevant for the cosmetics industry, as they will define labelling requirements, recycled content calculation rules, and material reporting obligations that directly affect packaging compliance strategies.
