EU
8 New Cosmetic Substances Fully Restricted Since May 1, 2026
Regulation (EU) 2026/78 has officially entered into full application, introducing restrictions and prohibitions for 18 substances newly classified as CMRs under the CLP Regulation.
Among the substances now prohibited in cosmetics are:
- Perboric acid
- Certain forms of silver
- Carbon nanotubes
- Acetone oxime
At the same time, substances such as Hexyl Salicylate and silver powder remain allowed only under strict new conditions.
Notably:
- Hexyl Salicylate is now limited to 2% in hydroalcoholic fragrances
- It is prohibited in products intended for children under 3 years old
- No sell-through period applies; non-compliant products had to be removed from the EU market immediately on May 1, 2026
This update reinforces the EU’s automatic ban mechanism for substances classified as Carcinogenic, Mutagenic or Reprotoxic (CMR), unless a specific SCCS exemption is granted.
4-MBC Officially Withdrawn from the EU Market
The transitional period for 4-Methylbenzylidene Camphor (4-MBC / Enzacamene) has officially ended.
As of May 1, 2026:
- Products containing 4-MBC can no longer remain on the EU market
- Existing stock must be fully withdrawn
- No grace period or sell-through is allowed
This UV filter, historically used in sunscreens and SPF products, has faced increasing concern due to its potential endocrine-disrupting and reproductive toxicity profile.
Brands should urgently confirm:
- Product withdrawal across all channels
- Reformulation status
- Updated PIFs and safety reports
Acetophenone: SCCS Preliminary Opinion Raises Concerns for Natural Fragrances
The SCCS published a preliminary opinion on Acetophenone following its proposed classification as Reprotoxic Category 1B.
Although not commonly added intentionally, Acetophenone naturally occurs in several botanical extracts and essential oils used in fragrances.
The SCCS currently considers it safe only:
- As a natural trace constituent
- At concentrations below 100 ppm (0.01%) in the finished product
This assessment may significantly impact natural fragrance formulations if a formal exemption is not granted in future legislation.
Deadline for public comments: July 6, 2026
Hydroxycitronellal Under New SCCS Safety Review
Hydroxycitronellal, one of the most widely used floral fragrance ingredients in cosmetics, is now under reassessment by the SCCS.
The evaluation will focus on:
- Skin sensitization potential
- Adequacy of current concentration limits
- Validation of the QRA2 methodology for fragrance allergen risk assessment
This review could become a turning point for the future regulation of fragrance allergens in Europe.
At this stage, no compliance deadline has been announced.
Glyoxylic Acid Under Investigation After Renal Failure Cases
The European Commission has mandated a full SCCS safety assessment for Glyoxylic Acid, commonly used in hair straightening treatments marketed as “formaldehyde-free.”
The reassessment follows reports of acute kidney failure associated with products containing this ingredient.
Key concerns include:
- Potential formaldehyde release during heat application
- Consumer safety in professional hair smoothing treatments
Possible future outcomes may include:
- Concentration limits
- Mandatory warnings
- Full restrictions or bans
Brands using Glyoxylic Acid should begin reviewing reformulation strategies proactively.
USA
FDA Fragrance Allergen Labeling Rule Still Pending
Under MoCRA, the FDA is expected to introduce mandatory fragrance allergen disclosure requirements similar to the EU model.
The proposed rule was expected in May 2026 but has not yet been published.
Once implemented, the rule would require:
- Individual declaration of specific fragrance allergens
- Defined disclosure thresholds
- Significant label updates across product portfolios
Brands are advised to:
- Request full allergen breakdowns from fragrance suppliers
- Begin preparing for future labeling changes
A final rule is not expected before 2027.
PFAS Bans Continue Expanding Across U.S. States
State-level PFAS restrictions in cosmetics continue to accelerate in the absence of a federal ban.
Currently active bans include:
- California
- Colorado
- Maryland
- Minnesota
- Washington
Additional restrictions coming into force: January 1, 2026
- Maine
- Vermont
July 1, 2026
- Connecticut introduces mandatory PFAS labeling and prior notification requirements
PFAS are commonly associated with:
- Waterproof mascaras
- Long-wear foundations
- Lipsticks
- Waterproof makeup products
Brands should review:
- Raw materials
- Pigment dispersions
- Packaging components
- Supplier certifications
A unified reformulation strategy is becoming increasingly critical for nationwide compliance.
India
Injectable Aesthetic Products Are NOT Cosmetics, Says CDSCO
India’s CDSCO has officially clarified that injectable aesthetic products cannot be classified or marketed as cosmetics under Indian law.
Products administered by injection:
- Fall under the drug regulatory framework
- Require medical oversight and approvals
- Cannot be sold as cosmetic products
The clarification directly impacts:
- Dermal fillers
- Skin boosters
- Anti-aging injections
- Professional aesthetic products
Companies operating in India’s fast-growing aesthetic market should urgently reassess product classifications and regulatory pathways.
UPCOMING REGULATIONS & COMPLIANCE REMINDERS
EU – Formaldehyde-Releasing Preservatives
July 31, 2026
Products containing formaldehyde-releasing preservatives above 0.001% (10 ppm) must now display the warning: “releases formaldehyde”
Affected preservatives include:
- DMDM Hydantoin
- Imidazolidinyl Urea
- Quaternium-15
EU – 56 New Fragrance Allergens Labeling Deadline
July 31, 2026
Products newly placed on the EU market must individually declare 56 additional fragrance allergens when present at concentrations above the threshold.
Sell-through for existing stock: Until July 31, 2028
July 15, 2026
The UK will prohibit the placing on the market of new cosmetic products containing 4-MBC.
Sell-through allowed until: January 15, 2027
UK – New Formaldehyde Threshold
July 15, 2026
Mandatory warning labeling threshold lowered to: 0.001% total formaldehyde
UK – 16 New CMR Substance Prohibitions
August 15, 2026
Includes restrictions affecting:
- UV nail gels
- Professional salon products
- Packaging-related contamination risks (TPO)
CANADA – Expansion from 24 to 81 Fragrance Allergens
August 1, 2026
Canada will align with the EU fragrance allergen list, expanding mandatory disclosure requirements from 24 to 81 allergens.
Existing compliant inventory may remain on the market until: August 1, 2028
Brands should already be coordinating with fragrance suppliers to obtain full allergen compositions.
