Sunscreen Regulation

Australia TGA Webinar On Proposed Reforms To Sunscreen Regulation

Australia’s medicines regulator has released a webinar and slide deck explaining consultation proposals to tighten sunscreen testing, labelling, cosmetic SPF claims and manufacturing guidance, with feedback invited from industry and other stakeholders. If implemented, these options could materially raise expectations on SPF evidence, laboratory accreditation and product labelling for sunscreen sponsors and manufacturers in Australia, so teams should review the proposals and prepare for tighter oversight.

23 May 2026, 19:39tga.gov.auAustralia

NEN Publishes New SPF Measurement Standards NEN‑EN‑ISO 23675:2025 and NEN‑EN‑ISO 23698:2025

NEN has published two ISO-based sunscreen standards, NEN‑EN‑ISO 23675:2025 (in vitro SPF method) and NEN‑EN‑ISO 23698:2025 (hybrid in vitro/skin method), providing new alternatives to traditional in vivo SPF testing for cosmetic products. These harmonised methods give sunscreen manufacturers and laboratories more reproducible, ethically favourable approaches for substantiating SPF claims and may quickly become reference methods across the cosmetics sector.

24 Apr 2026, 12:11nen.nlNetherlands

China NIFDC Finalises Trial Technical Guidelines for Hair Dye, Perm and Sunscreen Cosmetics

China’s National Institutes for Food and Drug Control has issued six trial technical guidelines, effective 15 April 2026, standardising research and quality-control expectations for hair dye, hair perm and sunscreen cosmetics. These guidelines embed CSAR requirements into detailed study and dossier expectations, raising the evidentiary bar for safety, efficacy and labelling for special cosmetics sold in China.

22 Apr 2026, 21:04cosmetic.chemlinked.comChina

China NIFDC Finalizes Six Technical Guidelines for Hair Dye, Hair Perm and Sunscreen Cosmetics

On 15 April 2026, China’s NIFDC issued six trial technical guidelines and related Q&A documents on the research and quality control of hair dye, hair perm and sunscreen cosmetics. These guidelines clarify how special cosmetics dossiers under China’s CSAR framework should evidence safety, efficacy and quality, raising expectations for testing, documentation and lab practices for any brand targeting these product categories in the Chinese market.

22 Apr 2026, 20:55cosmetic.chemlinked.comChina

Australia TGA Opens Consultation On Improving Sunscreen Regulation

Australia has initiated a comprehensive consultation to modernize sunscreen regulations, focusing on SPF testing reliability, laboratory oversight, and ingredient standards. Businesses should anticipate stricter quality assurance mandates, updated manufacturing guidelines, and harmonized labeling requirements across therapeutic and cosmetic categories.

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 and quality of BuRO-NVWA risk assessments for 2023–2024, targeting PFAS, food supplements, and sunscreen efficacy. This validation strengthens the legal basis for risk-based enforcement and signals that these specific product categories remain high-priority targets for regulatory oversight.

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

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

Brazil is advancing legislation to reclassify sunscreens and insect repellents as essential goods, paving the way for significantly reduced tax rates. This fiscal shift will require manufacturers to recalibrate pricing strategies and tax compliance as these categories transition from luxury to essential status.

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

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

Vietnam is overhauling its cosmetic regulatory framework to align with ASEAN standards, introducing mandatory Good Manufacturing Practice certification and stricter pre-market notification. Businesses must audit manufacturing compliance and supply chain documentation to meet enhanced post-market surveillance and updated certification deadlines through 2027.

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

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

The EU has established a 1 mg/kg contamination limit for the banned plasticiser DnHexP in sunscreens, with market placement restrictions taking effect on 1 January 2027. Manufacturers must immediately audit UV filter supply chains and production processes to ensure technical compliance and mitigate significant reprotoxic exposure risks identified in recent biomonitoring studies.

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 federal court has allowed a class action to proceed against L'Oreal regarding foundation labels that allegedly mislead consumers about the duration of SPF protection. This ruling signals heightened litigation risk for manufacturers of cosmetic-OTC hybrids if essential safety instructions are obscured or separated from primary marketing claims on packaging.

3 Feb 2026, 16:57govinfo.govUnited States

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

The EU Scientific Committee on Consumer Safety is advancing the 13th revision of its Notes of Guidance to update technical standards for exposure and toxicokinetic assessments. These updates will raise the evidentiary requirements for cosmetic safety dossiers, requiring manufacturers to recalibrate testing protocols and risk assessment strategies to ensure continued compliance.

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

Australia TGA Issues Statement on Sunscreen Labelling Practices

Australia’s TGA has initiated a strict enforcement campaign against sunscreens with labelling that does not exactly match their official regulatory register entries. Companies must immediately verify registration alignment for all branded and white-label products to mitigate the risk of forced market withdrawals and significant 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 comprehensive amendments to its cosmetic regulations, headlined by a total phase-out of PFAS and stricter limits on UV filters. Businesses must initiate immediate formulation audits and supply chain reviews to manage staged market prohibitions and ensure alignment with updated ingredient schedules.

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 intensified enforcement against skincare manufacturers for failing to maintain quality unit oversight and comply with mandatory over-the-counter drug listing requirements. Companies must ensure that administrative registration is accurate to avoid triggering deep-dive inspections that expose broader manufacturing, impurity control, and supply chain vulnerabilities.

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%. This development offers manufacturers the first opportunity in decades to modernize US sunscreen formulations with a new UV filter, enhancing market competitiveness and product performance.

12 Dec 2025, 10:31federalregister.govUnited States

ECHA Publishes Initial Comments on Octocrilene Restriction Consultation

ECHA is moving forward with a REACH restriction on the UV filter octocrilene, with a public consultation period open until March 2026. The proposal forces a strategic review of product portfolios as manufacturers face multi-year reformulation timelines and the potential loss of global ingredient alignment.

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 mandated a safety assessment for Cresyl Methoxycinnamate as a potential new UV filter, with an SCCS opinion expected by October 2026. A positive outcome would expand the list of authorized UV filters in the EU, requiring formulators to align with specific concentration limits for future market access.

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

Denmark Submits CLH Intention for Oxybenzone for Endocrine Disrupting Classification

Denmark has formally notified its intention 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 bans or severe restrictions in cosmetics and consumer products, necessitating immediate reformulation planning and supply chain risk 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 trace levels, with a public consultation open until March 2026. This proposal necessitates immediate reformulation of UV-filter portfolios and supply chain assessments to meet the proposed two-year compliance deadline.

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