Regulatory Standards for Zinc Oxide in Cosmetics Across Regions

Zinc oxide (ZnO) is a widely used inorganic ingredient in cosmetics and personal care, valued for its broad-spectrum UV protection, skin-protectant properties, and white pigmenting capacity. Because ZnO is used in both “cosmetics” and in certain over-the-counter (OTC) drug categories (notably sunscreens and skin protectants) in some markets, regulatory standards vary by region and product type. This article explains what’s permitted and under what conditions, covering concentration limits, nanoparticle-specific rules, aerosol restrictions, labeling, and approval pathways across the EU, US, Japan, China, and ASEAN.

Below, we define the regulatory frameworks, compare key limits and conditions, unpack nano-specific safety expectations, and discuss market and compliance implications. We conclude with a forward look at harmonization and practical recommendations for both large and smaller manufacturers.

What counts as “regulatory standards” for ZnO?

Regulatory standards for zinc oxide in cosmetics include: maximum permitted concentrations, which product categories can contain ZnO (e.g., UV filters in sunscreens), nano-scale restrictions and testing expectations, ingredient listing and labeling duties (including [nano] where applicable), notification/registration or premarket authorization requirements, and evidence standards (e.g., SPF/UVA testing, safety assessments, PIF or dossier).

EU Regulatory Framework

The EU regulates cosmetics under Regulation (EC) No 1223/2009. Zinc oxide is an approved UV filter up to 25% in both non-nano (bulk) and nano forms, subject to specific nano conditions and an inhalation restriction. The EU applies a “precautionary principle” and a robust premarket rule-set for nanomaterials in cosmetics.

Key pillars

Legal basis and Annexes: ZnO is listed as a permitted UV filter in Annex VI of Regulation (EC) No 1223/2009, as amended by Commission Regulation (EU) 2016/621 (maximum 25% m/m).
Nano authorization and restrictions: The nano-form of ZnO is permitted as a UV filter at up to 25%, but not in applications that may lead to exposure of the end-user’s lungs by inhalation (e.g., spray/aerosol). INCI labeling must include [nano] for nanomaterials per Article 19.
Safety opinions: The European Commission’s Scientific Committee on Consumer Safety (SCCS) has concluded ZnO (nano) is safe as a UV filter up to 25% for dermal use, excluding applications with possible inhalation exposure (SCCS opinions underpinning the 2016 amendment). The SCCS has also published dedicated guidance on how to assess nano safety in cosmetics.
Evidence and product file: A Product Information File (PIF) with a Cosmetic Product Safety Report (CPSR) by a qualified safety assessor is mandatory; nanomaterial use must be captured in the PIF and label. CPNP notification applies.

Illustrative EU compliance steps for a ZnO sunscreen

Confirm ZnO spec matches Annex VI conditions (including any applicable nano characteristics).
Conduct safety assessment and compile PIF/CPSR.
Perform SPF/UVA testing per accepted standards (e.g., ISO 24444, ISO 24443), substantiate claims.
Notify via CPNP; ensure INCI labelling includes [nano] if applicable.
Avoid aerosolized formats that could lead to inhalation exposure with nano ZnO.

US FDA Regulations

In the United States, zinc oxide has three distinct regulatory contexts: color additive (cosmetics), OTC skin protectants, and OTC sunscreens. The US tends to apply a risk-based approach, relying on monographs and performance-based testing for OTC drugs.

Key pillars

Color additive for cosmetics: Zinc oxide is permanently listed for use in cosmetics (including the eye area) under 21 CFR 73.2991 (exempt from certification). This governs ZnO as a colorant in cosmetics.
OTC skin protectants: Under 21 CFR Part 347, ZnO (1–25%) is an allowed active for skin protectant drug products (e.g., diaper rash). Products must meet the applicable drug facts labeling and compliance with the monograph conditions.
OTC sunscreens: FDA regulates sunscreens as OTC drugs, not cosmetics. Under the modernized OTC framework (CARES Act, 2020), FDA’s September 2021 proposed order on sunscreens indicates zinc oxide (and titanium dioxide) are GRASE active ingredients when formulated and labeled per conditions; 21 CFR 201.327 sets SPF/broad-spectrum testing and labeling requirements. Companies must comply with performance testing and Drug Facts labeling for sunscreens.

Practical US distinctions

Cosmetics vs. drugs: Makeup with ZnO as a colorant is regulated as a cosmetic; sunscreen claims (sunburn protection, SPF) trigger OTC drug status and more stringent requirements, including SPF/UVA testing, Drug Facts, and facility drug listing.
Nano: The US has no horizontal nano labeling requirement for cosmetics; however, FDA expects safety to be substantiated. For spray/aerosol products, companies should consider inhalation risk and relevant FDA guidance.

Asian Markets (Japan, China, ASEAN)

Japan

Japan regulates cosmetics and quasi-drugs under the PMD Act. Most high-SPF sunscreens are quasi-drugs with positive lists of UV filters and standardized test methods specified in Ministry of Health, Labour and Welfare (MHLW) notifications.

Status: Zinc oxide is permitted as a UV filter in sunscreens (quasi-drugs) and as a cosmetic colorant, subject to MHLW standards and notifications. Final concentration limits and testing requirements are determined under the relevant quasi-drug frameworks and approvals.
Nano: Japan does not mandate an EU-style [nano] ingredient label; regulators expect safety justification for particle size distributions and coatings in quasi-drug applications. Applicants should be prepared to provide nanomaterial characterization and dermal safety evidence.

China

China’s Cosmetic Supervision and Administration Regulation (CSAR, 2020) and the Safety and Technical Standards for Cosmetics (STSC) govern ingredient lists and safety.

Status: The STSC positive list for sunscreen agents includes zinc oxide with a maximum permitted concentration of 25% (dermal use).
Nano: CSAR requires special attention to nanomaterials; NMPA has issued guidelines on safety assessment of cosmetics containing nanomaterials. As in the EU, uses that may result in inhalation exposure face heightened scrutiny or restriction.
Registration/filing: Sunscreen products and new ingredients follow registration or filing pathways, with safety and efficacy substantiation (including SPF/UVA testing per Chinese standards).

ASEAN

The ASEAN Cosmetic Directive (ACD) and ASEAN Cosmetic Scientific Body (ACSB) updates closely align with EU Annex structures.

Status: Zinc oxide is listed as a permitted UV filter in Annex VII (mirroring EU) at up to 25%.
Nano and aerosols: ASEAN adopts EU-like conditions on aerosol/inhalation restrictions for nano ZnO in many implementations. The 2024-02 ACSB updates consolidate ongoing alignment with EU safety positions.
Market entry: The ACD uses a notification and responsible person model; companies must hold a Product Information File locally and conform to ASEAN labeling and claims standards.

Table 1. At-a-glance regulatory status for zinc oxide in cosmetics/sunscreens

Region	Legal basis	Category	Max conc.	Nano allowed	Aerosol/spray with nano
EU	Reg. (EC) 1223/2009; Reg. (EU) 2016/621	UV filter (cosmetic)	25%	Yes, with [nano] labeling	Not permitted if lung exposure likely
US	21 CFR 73.2991 (cosmetics), 21 CFR 347 (skin protectant), Sunscreen Proposed Order (2021) + 21 CFR 201.327	Cosmetic colorant; OTC drugs	Colorant: GMP; Skin protectant: 1–25%; Sunscreen: ZnO GRASE conditions	No specific nano label	Spray products require safety justification; follow labeling/testing
Japan	PMD Act; MHLW Standards/Notifications	Cosmetics and quasi-drugs	Per QD standards/approvals	Allowed with justification	Inhalation risks evaluated case by case
China	CSAR (2020); STSC (latest)	UV filter (cosmetic)	25%	Allowed with nano assessment	Restricted where inhalation exposure could occur
ASEAN	ACD + ACSB Updates	UV filter (cosmetic)	25%	Generally aligned with EU	Generally not allowed for inhalable formats

Safety Considerations: Bulk vs. Nano, Inhalation, Environment

Bulk vs. nano: The benefits of zinc oxide include broad-spectrum UV protection via scattering and absorption. The nano form (typically ~20–100 nm with coatings) increases transparency while maintaining UV efficacy. EU and SCCS assessments support dermal safety at up to 25% for nano ZnO in sunscreens when formulated to minimize penetration and photoreactivity; however, inhalation exposure poses additional risk.
Inhalation: EU explicitly prohibits nano ZnO in applications that may lead to lung exposure. OECD and SCCS emphasize tailored inhalation risk assessment for aerosol/spray products. The US requires companies to ensure sprays are safe for intended use; inhalation toxicology should be part of product development if fine particles are generated.
Environmental fate: Regulatory and scientific bodies are increasingly evaluating the environmental impact of ZnO, especially nanoparticulate forms, addressing dissolution to zinc ions, aquatic toxicity, and fate in wastewater/biosolids. Policymakers and companies should monitor evolving guidance (e.g., UNEP/OECD reports) and pursue coatings/formulations that reduce bioavailability and environmental release.

Table 2. Nano-specific regulatory expectations

Aspect	EU	US	Japan	China	ASEAN
Definition/label	[nano] on INCI; Article 2(1)(k), Article 19	No specific label	No horizontal “nano” label	Nano noted in dossiers; ingredient info platform	No unified label; country practice varies
Premarket action	If nano not listed in Annexes: Art. 16 notification; ZnO nano is listed in Annex VI	Not applicable for cosmetics; OTC drugs follow monograph/proposals	Quasi-drug approvals may require nano characterization	NMPA technical guideline for nano safety; registration/filing includes nano info	Notification + PIF; follow ACSB guidance
Inhalation control	Explicit restriction for nano ZnO	Case-by-case; ensure safe use	Case-by-case	Restricted if inhalation exposure possible	Generally aligns with EU restriction

Market Implications: Compliance Costs, Innovation, Consumer Trends

Compliance costs rise with regulatory stringency (Regulatory stringency → increases → compliance costs). Nano characterization, particle coating stability, and inhalation risk assessments add complexity. EU PIF/CPSR work and US OTC testing (SPF/UVA and labeling under 21 CFR 201.327) are major cost drivers.
Innovation trade-offs: While nano ZnO improves aesthetics (lower whitening), stringent aerosol restrictions and documentation can slow adoption in sprays. Companies may invest in microfine but non-nano grades or hybrid filters to balance performance and compliance (Nano restrictions → protect → consumer safety).
Consumer trends: Demand for “mineral” sunscreens is strong, with sensitivity-conscious and reef-care messaging. However, environmental scrutiny is increasing, pushing brands to substantiate “reef-friendly” claims and consider coatings that mitigate ion release.
Large vs. small companies: Large firms benefit from in-house regulatory and toxicology capabilities, easing burdens for nano dossiers and multi-region filing. Smaller manufacturers may favor bulk ZnO or outsource testing and regulatory strategy to avoid protracted development timelines.

Table 3. Documentation and testing touchpoints by region

Requirement	EU (cosmetic UV)	US (cosmetic colorant)	US (OTC sunscreen)	Japan (quasi-drug sunscreen)	China (cosmetic UV)
Safety assessment	CPSR in PIF; nano rationale	Cosmetic safety substantiation	Full OTC safety per monograph; nano justification	QD dossier with safety, including nano	Dossier per CSAR/STSC; nano technical report
Performance	SPF/UVA per ISO; claims substantiation	N/A	SPF/Water resistance per 21 CFR 201.327	Per MHLW test standards	Per Chinese GB/industry standards
Labeling	INCI + [nano]; UV filter compliance	INCI; no nano flag	Drug Facts; active ZnO listed; warnings	Per QD labeling rules	Ingredient label per CSAR; nano disclosed in filing
Premarket	CPNP notification	No premarket approval	Monograph compliance; listing	QD approval	Registration/filing

Cross-Regional Comparison: Precaution vs. Risk-based

The EU’s precautionary principle translates to a preemptive control of nano materials: explicit annex entries, [nano] labeling, and aerosol restrictions.
The US risk-based approach focuses on performance and safe use conditions (e.g., SPF/UVA testing), with nano addressed through general safety expectations rather than horizontal labeling rules.
Japan and China blend both approaches: structured positive lists and approvals (Japan QD, China STSC/CSAR) and growing nano-specific guidance.

Future Outlook: Harmonization and Emerging Technologies

Harmonization: ASEAN continues to align with EU Annexes; China updates the STSC regularly and has expanded guidance on nano safety; the US continues to refine OTC frameworks via the CARES Act process. Over time, dossiers demonstrating minimal penetration, low photoreactivity, and controlled airborne particle profiles may enable more consistent acceptance.
Testing and analytics: Improved in vitro, in silico tools for nanoparticle characterization, photostability, and dissolution to zinc ions will streamline assessments. The SCCS guidance and OECD nano test frameworks are maturing, fostering comparability.
Sustainability: Brands are investing in more inert coatings, optimized particle size distributions, and packaging that reduces environmental release. Life cycle assessments and wastewater fate studies are increasingly part of ESG and regulatory narratives.

Conclusion

Zinc oxide is broadly permitted up to 25% as a UV filter across the EU, China, and ASEAN and is recognized by FDA as a GRASE sunscreen active in the US, with nano forms acceptable for dermal use but restricted in inhalable formats. To comply, brands must choose the right grade (bulk vs. nano), align SPF/UVA testing with regional standards, and meet labeling and documentation requirements (e.g., EU [nano], US Drug Facts, China CSAR/STSC). As a dedicated zinc oxide manufacturer, Global Chemical supplies consistent bulk and nano cosmetic grades alongside complete technical dossiers (TDS, SDS, CoA, particle size/coating data) and regulatory guidance to streamline EU, US, Japan, China, and ASEAN launches. Contact Global Chemical for samples and a region-ready compliance and documentation bundle.