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17 Jun 2025
Global Cosmetics Regulatory Updates - May 2025
Keywords
I. European Cosmetics Regulatory Updates
1. EU SCCS Issues Final Opinion on Butylparaben
On May 2, 2025, the EU Scientific Committee on Consumer Safety (SCCS) published its final opinion on butylparaben (SCCS/1674/25). The SCCS concluded that a maximum concentration of 0.14% (as acid) in all assessed cosmetic products is unsafe for children aged 0.5-10 years when used in combination, except for body lotions. However, at these reduced levels, butylparaben is deemed safe for all age groups when used individually or in combination.
2. EU SCCS Releases Final Opinion on Salicylic Acid
On May 2, 2025, the SCCS issued its final opinion on salicylic acid (SCCS/1675/25). It determined that for children aged 3-10, salicylic acid is safe only in single-use skin and oral care products (excluding body lotions). Recommended limits:
- Rinse-off products: 0.5%
- Leave-on products: 0.15%
- Oral care products: 0.1%
3. EU SCCS Publishes Preliminary Opinion on Methyl Salicylate
On May 2, 2025, the SCCS released an assessment (SCCS/1676/25) revising SCCS/1654/23, stating that methyl salicylate is safe for children aged 0-3 only at:
- ≤0.4% in toothpaste
- ≤0.02% in other products
4. EU Updates Cosmetic Ingredient Lists with CMR Substances
On May 12, 2025, the European Commission adopted Regulation (EU) 2025/877, amending Annexes II (banned) and III (restricted) of Regulation (EC) No 1223/2009 to include newly classified carcinogenic, mutagenic, or reprotoxic (CMR) substances under CLP Regulation (EC) No 1272/2008. The regulation takes effect on September 1, 2025.
5. EU Proposes Further Cosmetic Ingredient List Revisions
On May 21, 2025, the EU notified the WTO (G/TBT/N/EU/1140) of plans to amend Regulation (EC) No 1223/2009, updating:
- Annex II (banned)
- Annex III (restricted)
- Annex IV (permitted colorants)
- Annex V (permitted preservatives)
The changes incorporate CMR substances identified in the June 2024 update to CLP Regulation Annex VI, with adoption expected in Q1 2026.
6. EU Plans "Animal Testing-Free" Roadmap by Q1 2026
On May 27, 2025, EU Executive Vice-President Séjourné announced that the Commission will finalize an action roadmap by Q1 2026 in response to the European Citizens' Initiative (ECI) "Save Cruelty-Free Cosmetics." The plan aims to integrate New Approach Methodologies (NAMs) into 15 legislative areas, including REACH, to phase out animal testing.
7. UK Proposes Restrictions on Benzophenone-3 in Cosmetics
On May 8, 2025, the UK submitted a WTO notification (G/TBT/N/GBR/102) to tighten limits on benzophenone-3 in cosmetics. If approved, the rules will take effect on January 21, 2026, with a 6-month sell-through period for non-compliant products.
8. UK SAG-CS Issues Final Opinion on Formaldehyde Releasers
In May 2025, the UK's Scientific Advisory Group on Chemical Safety (SAG-CS) finalized its opinion (SAG-CS Opinion 16), recommending a labeling threshold of 10 ppm (0.001%) for formaldehyde-releasing preservatives in leave-on and rinse-off products.
9. UK SAG-CS Approves Homosalate in Sunscreens
The SAG-CS (Opinion 17) confirmed that homosalate is safe in sunscreens at concentrations up to 10%.
10. UK SAG-CS Raises Concerns Over 4-MBC
In its preliminary opinion (SAG-CS Opinion 18), the group found insufficient data to confirm the safety of 4-methylbenzylidene camphor (4-MBC) in sunscreens due to potential genotoxicity and endocrine disruption risks.
II. North American Cosmetics Regulatory Updates
1. California Proposes Listing 12 Acids/Bases as Candidate Chemicals
On April 24, 2025, California's DTSC moved to add 12 acids and bases to its Candidate Chemicals List, citing risks of skin burns, eye damage, and reproductive toxicity. The comment period has closed.
2. Canada Updates Cosmetic Ingredient Hotlist
On May 14, 2025, Health Canada proposed revisions to its Hotlist, including 3 new ingredients and updates to 4 existing entries.
3. FDA Refuses 83 Cosmetic Shipments in April 2025
The U.S. FDA rejected 83 batches of cosmetics from 14 countries, primarily due to:
- Unapproved drug claims
- Non-compliant colorants
- Labeling violations
Top non-compliant origins: China (17 refusals), Portugal (12), Canada/India (9 each). Non-compliant products face rejection or destruction if corrective actions fail.
III. South American Cosmetics Regulatory Updates
1. Brazil Clarifies Rules for Cosmetic Registration Supplements
On May 29, 2025, Anvisa announced that addenda to cosmetic registration dossiers will only be accepted before technical review begins. The rule takes effect on June 9, 2025.
IV. Asian Cosmetics Regulatory Updates
1. Taiwan (China) Publishes Testing Methods for Fragrances & Preservatives
- April 10, 2025: Released methods for 15 fragrance ingredients.
- May 21, 2025: Issued Method (6) for 15 preservatives.
2. Thailand Imposes New Rules on Titanium Dioxide in Powders
Effective April 21, 2025, Thai FDA requires stricter controls on powdered titanium dioxide (≥1% inhalable particles ≤10 μm) in:
- Loose powders/pressed cosmetics
- Spray/aerosol products
Manufacturers must document compliance in Product Information Files (PIFs).
3. Indonesia Revises Cosmetic Safety & Efficacy Assessment Rules
On April 29, 2025, BPOM proposed streamlined submission requirements, including a "fast-track" assessment pathway and clearer timelines.
4. Thailand Launches e-Certificate System for Health Products
Since May 1, 2025, Thai FDA has mandated electronic certification for cosmetics, foods, and medical devices via its e-Submission platform.
5. Malaysia Digitizes Halal Certification
From May 5, 2025, JAKIM issues e-Cert halal approvals via MYeHALAL, with printed certificates available for a fee.
6. Vietnam Drafts Modernized Cosmetics Regulation
On May 15, 2025, Vietnam's MoH released a Cosmetics Management Decree (draft), covering notification, production, imports, PIFs, labeling, recalls, and more.
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revision for all the information.