Sunscreen Regulation

Australia TGA Opens Consultation On Improving Sunscreen Regulation

Australia’s TGA has launched a consultation to modernize sunscreen regulation, targeting SPF testing reliability, laboratory oversight, and ingredient standards. Manufacturers should prepare for stricter quality assurance requirements, updated GMP guidance, and harmonized labeling rules between therapeutic and cosmetic products.

28 Mar 2026, 20:27tga.gov.auAustralia

Netherlands Submits Advisory Council Evaluation Of BuRO-NVWA Risk Assessments 2023–2024 To Parliament

Dutch authorities have validated the scientific independence of BuRO-NVWA risk assessments for 2023–2024, covering priority topics like PFAS in food and sunscreen efficacy. This confirmation strengthens the legal and scientific basis for future NVWA enforcement actions and signals heightened regulatory focus on these specific substance and product categories.

19 Mar 2026, 08:34open.overheid.nlNetherlands

Brazilian Chamber CCJ Approves Bill to Classify Repellents and Sunscreens as Essential Goods

Brazil is advancing legislation (PLP 11/2024) to classify sunscreens and insect repellents as essential goods, enabling significantly lower tax rates. This fiscal reclassification aims to reduce consumer prices and requires manufacturers to prepare for shifts in pricing strategy and tax compliance.

9 Mar 2026, 18:39camara.leg.brBrazil

Viet Nam Proposes Decree on Management of Cosmetics (WTO TBT Notification G/TBT/N/VNM/393)

Vietnam has proposed a comprehensive new regulatory framework for cosmetics, aligning national requirements with ASEAN standards and mandating CGMP compliance. Businesses must prepare for stricter pre-market notification, mandatory Good Manufacturing Practice certification, and enhanced post-market surveillance for high-risk categories.

9 Mar 2026, 14:47members.wto.orgVietnam

Germany (UBA) Reports Widespread MnHexP Exposure in Children and Adolescents

The EU has codified a strict 1 mg/kg contamination limit for the banned plasticiser DnHexP in sunscreens, effective 1 January 2027, following widespread detection in biomonitoring studies. Manufacturers using the UV filter DHHB must urgently audit supply chains and production processes to ensure compliance with this technical feasibility threshold and mitigate reprotoxic exposure risks.

24 Feb 2026, 19:21umweltbundesamt.deGermanyEuropean Union

US District Court (N.D. Cal.) Partially Allows Class Action Over L'Oreal 24-Hour SPF Foundation Claims

A California court has partially allowed a class action to proceed against L'Oreal over "24H" foundation claims that potentially mislead consumers regarding SPF protection duration. This ruling highlights significant litigation risk for cosmetic-OTC hybrids where long-wear marketing and SPF reapplication instructions are not clearly and concurrently visible on primary packaging.

3 Feb 2026, 16:57govinfo.govUnited States

EU SCCS Methodologies Working Group Continues 13th Revision of Notes of Guidance

The EU SCCS is advancing the 13th revision of its Notes of Guidance, updating methodologies for exposure modelling, toxicokinetics, and CMR substance assessments. These changes will redefine the technical benchmarks for cosmetic safety dossiers, requiring firms to align their testing and risk assessment strategies with new scientific standards.

30 Jan 2026, 18:40health.ec.europa.euEuropean Union

Australia TGA Issues Statement on Sunscreen Labelling Practices

Australia’s TGA has intensified enforcement against non-compliant sunscreen labelling, declaring products with mismatched ARTG entries as unlawful for supply. Companies must immediately audit "white-labelled" or customized products to ensure registration alignment, as the regulator signals a shift toward aggressive market withdrawals and civil penalties.

29 Jan 2026, 19:16tga.gov.auAustralia

New Zealand EPA Implements Updated Cosmetic Products Rules, Including PFAS Phase-Out

New Zealand has implemented major amendments to its cosmetic regulations, effective January 1, 2026, including a landmark phase-out of PFAS and tighter restrictions on UV filters. Businesses must initiate immediate supply chain audits to manage the transition toward total PFAS elimination and ensure compliance with updated ingredient schedules aligned with EU standards.

24 Jan 2026, 08:32epa.govt.nzNew Zealand

US FDA Issues Warning Letter To Private Label Skin Care Inc Over CGMP And OTC Drug Listing Violations

The FDA has issued a warning letter to a skincare manufacturer for significant CGMP violations and failure to register over-the-counter (OTC) drug products. This enforcement highlights the agency's rigorous focus on quality unit accountability and demonstrates that administrative listing failures can trigger deep-dive inspections into manufacturing and impurity controls.

6 Jan 2026, 08:19fda.govUnited States

US FDA Proposes to Add Bemotrizinol to OTC Sunscreen Monograph

The US FDA has proposed adding bemotrizinol to the OTC sunscreen monograph as a safe and effective active ingredient at concentrations up to 6%. If finalized, this expansion of the permitted UV filter palette will allow manufacturers to introduce new sunscreen formulations to the US market for the first time in decades.

12 Dec 2025, 10:31federalregister.govUnited States

ECHA Publishes Initial Comments on Octocrilene Restriction Consultation

ECHA is advancing a REACH restriction on the UV filter octocrilene, signaling a major shift for the cosmetics industry as regulators target environmental and endocrine risks. Businesses face complex reformulation challenges and the potential loss of global product alignment, requiring long-term strategic planning for alternative ingredient sourcing.

11 Dec 2025, 10:37echa.europa.euEuropean Union

China Announces 48 Cosmetic Products Found Non-Compliant in 2025 Sampling

China’s NMPA has flagged 48 cosmetic product batches for non-compliance following national sampling inspections in late 2025. Heightened enforcement targeting formulation consistency and ingredient authorization signals a need for stricter supply chain oversight and rigorous registration alignment for the Chinese market.

18 Nov 2025, 09:29nmpa.gov.cnChina

European Commission Requests SCCS Safety Assessment of Cresyl Methoxycinnamate as New UV Filter in Cosmetics

The European Commission has initiated a safety assessment for Cresyl Methoxycinnamate as a new UV filter, with an SCCS opinion expected by October 2026. This process signals a potential expansion of authorized UV filters in the EU, offering formulation opportunities while establishing strict concentration limits for market access.

10 Nov 2025, 16:20health.ec.europa.euEuropean Union

Denmark Submits CLH Intention for Oxybenzone for Endocrine Disrupting Classification

Denmark has initiated a proposal to classify the UV filter oxybenzone as an endocrine disruptor for human health and the environment under EU CLP. This classification would likely trigger automatic restrictions or bans in cosmetics and consumer products, requiring manufacturers to prioritize reformulation and supply chain impact assessments.

15 Oct 2025, 15:08echa.europa.euEuropean Union

ECHA Proposes EU-Wide Restriction on Octocrilene in Cosmetics

ECHA has proposed a REACH restriction to limit Octocrilene in cosmetics to below 0.001% w/w, with a public consultation open until March 2026. Businesses must accelerate reformulation efforts and supply chain assessments for UV-filter portfolios to align with the proposed two-year transition window.

24 Sept 2025, 14:22echa.europa.euEuropean Union

HSE Technical Report Confirms Aquatic Toxicity Classification of 2-Ethylhexyl (2E)-3-(4-Methoxyphenyl)acrylate

The UK HSE has recommended a high-potency aquatic toxicity classification for the common UV filter 2-ethylhexyl (2E)-3-(4-methoxyphenyl)acrylate. Companies should prepare for mandatory labeling updates and potential supply chain shifts as GB CLP aligns with EU-level environmental hazard assessments.

22 Sept 2025, 08:38hse.gov.ukUnited Kingdom

Australia Consults on Sunscreen Ingredient Restrictions Under Poisons Standard

Australia is proposing new concentration limits and usage restrictions for homosalate, oxybenzone, and benzophenone in sunscreens, with a decision process continuing through late 2025. Manufacturers should prepare for potential reformulations and updated labeling requirements as the TGA aligns its sunscreen safety standards with international regulatory trends.

25 Aug 2025, 10:49eping.wto.orgAustralia

FDA Warns Supergoop Over Misbranded Sunscreen Mousse

The FDA has issued a warning letter to Supergoop! for marketing a sunscreen mousse that falls outside authorized OTC monograph dosage forms (August 2025). This enforcement signals a strict stance on non-standard delivery systems, requiring brands to ensure all OTC product formats have explicit regulatory authorization to avoid market withdrawal.

14 Aug 2025, 15:38fda.govUnited States

SAG-CS Confirms 10% Homosalate Use Safe in Sunscreen Products

The UK Scientific Advisory Group on Chemical Safety (SAG-CS) has concluded that homosalate is safe for use as a UV filter in sunscreens at concentrations up to 10%. This confirms a regulatory divergence from the EU's stricter 0.5% limit, allowing for higher concentrations in the UK but requiring distinct formulation management for cross-border compliance.

21 May 2025, 09:16gov.ukUnited Kingdom