Navigating Emerging Chemicals in SDS Documentation: PFAS, Microplastics, and Beyond

1. Documenting PFAS: The Regulatory Moving Target

Current PFAS Regulatory Status

Per- and polyfluoroalkyl substances (PFAS) represent one of the most challenging chemical groups for SDS authors in 2025. These "forever chemicals" have gained increased regulatory scrutiny due to their environmental persistence and potential health impacts. Key regulatory developments include:

• EPA Toxic Release Inventory (TRI): Reports for the 2024 Reporting Year due by July 1, 2025
• Toxic Substances Control Act (TSCA): Reporting for years 2011-2022 opening in November 2024
• Reporting thresholds: 100 pounds (45.4 kg) for TRI-listed PFAS compounds
• TSCA reporting: Now applies to any amount of certain PFAS manufactured or imported since 2011

The widespread distribution of PFAS compounds—found in approximately 30 percent of surface waters and 20 percent of drinking water tested in the US, as well as in over 95 percent of living organisms worldwide—has prompted increasingly stringent global regulations. For SDS authors, this regulatory flux means documentation must reflect not only current compliance requirements but also anticipate pending regulatory changes.

PFAS Documentation Strategies

Effective PFAS documentation requires specific approaches:

• Substance-specific tracking: Identify exactly which PFAS compounds are present using precise CAS numbers
• Cross-jurisdictional monitoring: Document varying regulatory status across different markets
• Precautionary classification: Apply conservative hazard classifications when toxicological data is limited
• Clear substance identification: Ensure Section 3 clearly identifies specific PFAS compounds, not just generic chemical families

For PFAS-containing products, documentation plans should address both immediate compliance needs and anticipate future regulatory changes, with clear timelines for implementing updates based on known implementation dates for the July 1, 2025 TRI reporting deadline and upcoming TSCA reporting requirements.

2. Microplastics: Standardization in Progress

Microplastics Documentation Challenges

Microplastics present unique documentation challenges due to evolving scientific understanding and inconsistent regulatory approaches. The scientific community has recognized the need for harmonized reporting guidelines to increase validity, reproducibility, and comparability of microplastic studies.

Key documentation challenges for microplastics include:

• Inconsistent definitions: Varying size thresholds and composition criteria across jurisdictions
• Evolving test methods: Non-standardized analytical techniques for identification and quantification
• Limited toxicological data: Incomplete understanding of human health and environmental impacts
• Regional regulatory differences: Varying approaches to classification and reporting requirements

Current Standardization Efforts

Efforts toward standardized documentation of microplastics include:

• Harmonized reporting protocols: Developing best practices for reporting materials and quality assurance protocols
• Standardized sample preparation: Consistent techniques for microplastic identification and characterization
• Classification frameworks: Efforts to establish consistent hazard classification approaches
• Exposure assessment methodologies: Standardized approaches to evaluating exposure risks

SDS authors should document which specific definition of "microplastic" is being applied in each section of the documentation, and clearly note when regional variations in classification or labeling requirements apply to ensure accurate hazard communication.

3. Substances of Unknown Hazard Classification

South Korea's Approach to Unknown Hazards

South Korea's Ministry of Environment recently added a definition for "new substances of unknown hazard classification" to its K-REACH regulations. For these substances, regulations now require:

• Assuming substances of unknown hazard are hazardous until proven otherwise
• Implementing appropriate protective measures despite data gaps
• Documenting the precautionary approach taken for unknown hazards

This precautionary approach aligns with the Globally Harmonized System (GHS) philosophy but requires SDS authors to make difficult judgments about appropriate hazard communication in the absence of definitive data.

GHS-Aligned Weight-of-Evidence Documentation

For substances with incomplete hazard profiles, the GHS hazard classification system accommodates weight-of-evidence approaches. Effective documentation requires:

• Explicit identification of data sources used (e.g., studies, models, analog data)
• Quality scores for each data source based on standardized reliability criteria
• Consideration of both positive and negative findings in the final classification
• Clear documentation of classification boundaries when data falls between defined categories

The GHS specifically notes that "both positive and negative results are assembled together in a single weight-of-evidence determination," making comprehensive documentation of all available data essential for compliance.

4. Navigating Threshold Reporting Requirements for Emerging Chemicals

Global Variations in Emerging Chemical Thresholds

One of the most significant challenges for SDS authors is understanding and tracking the varying threshold reporting requirements for emerging chemicals across different jurisdictions:

South Korea's K-REACH Updates (2025)

• Notification threshold for production/import of new substances increased from 0.1 tons/year to 1 ton/year (effective January 1, 2025)
• Additional information requirements about new substances take effect August 7, 2025, including:
  • Substance name/CAS number
  • Purity and molecular formula
  • Structural formula
  • Identified impurities
  • Annual manufacturing/import volume
  • Intended use
  • Hazard classification/labeling
  • Scientific justification for hazard determinations

EU REACH Update on Emerging Contaminants

• Expanded reporting requirements for substances of very high concern (SVHCs)
• Enhanced requirements for persistent, mobile, and toxic (PMT) substances
• Stricter documentation for endocrine disrupting chemicals

Implementation Timelines and Compliance Windows

The phased implementation of new reporting requirements adds another layer of complexity for SDS authors. In South Korea, while the notification tonnage threshold change took effect on January 1, 2025, additional information requirements will be implemented starting August 7, 2025.

For global manufacturers and importers, tracking these implementation dates across multiple jurisdictions requires systematic monitoring of regulatory calendars across all relevant markets.

5. SDS Documentation Strategies for Emerging Chemicals

Substance-Specific Documentation Plans

For emerging chemicals of concern, develop substance-specific documentation plans that include:

• Regulatory status matrix: Current classification requirements across all relevant jurisdictions
• Monitoring protocol: Specific regulatory sources to monitor for each substance
• Update triggers: Events that necessitate SDS revision (e.g., threshold changes, new toxicity data)
• Implementation timeline: Schedule for incorporating known regulatory changes

Modular Documentation Architecture

Implementing a modular SDS architecture is particularly valuable for emerging chemicals with evolving regulatory status:

• Core substance data module: Physical/chemical properties, intrinsic hazards
• Regulatory classification modules: Jurisdiction-specific classification requirements
• Exposure control modules: Protection measures by exposure scenario
• Transportation modules: Mode-specific transport requirements

This approach allows targeted updates to specific modules when regulations change without requiring complete document revision. For microplastics specifically, this modular approach is particularly valuable given the lack of globally consistent definitions and regulatory frameworks.

Transparent Uncertainty Communication

For emerging chemicals with limited toxicological data, transparent communication of uncertainty becomes essential. SDS authors should:

• Clearly document the basis for hazard classifications, including any assumptions
• Identify data gaps that affect classification confidence
• Document when precautionary approaches have been applied due to limited data
• Provide context for hazard statements based on available evidence

For substances of unknown hazard classification, such as those defined in South Korea's updated regulations, a precautionary approach may be warranted—assuming potential hazards and recommending appropriate protective measures until more definitive data becomes available.

6. Future Trends in Emerging Chemical Documentation

Looking ahead, several key trends will impact SDS documentation for emerging chemicals:

• Enhanced precautionary principle application: Increasing regulatory emphasis on assuming hazards for substances with limited data
• Harmonization of reporting frameworks: Greater standardization of classification approaches for novel substances
• Expanded substance groups under regulation: More chemical families joining PFAS and microplastics as specifically regulated groups
• Enhanced transparency requirements: Greater regulatory emphasis on documenting the basis for classifications
• Integration of sustainability considerations: Incorporating information on environmental persistence and bioaccumulation

SDS authors should monitor these trends to anticipate documentation requirements for emerging chemicals of concern.

Conclusion: Building Resilience in Emerging Chemical Documentation

Successfully documenting emerging chemicals in today's rapidly evolving regulatory environment requires:

• Substance-specific regulatory monitoring across all relevant jurisdictions
• Precautionary approaches to hazard classification when data is limited
• Transparent documentation of the basis for hazard classifications
• Awareness of varying threshold requirements and implementation dates
• Flexible documentation structures that accommodate regulatory evolution

By implementing these approaches, SDS authors can maintain compliant documentation for emerging chemicals of concern like PFAS and microplastics, even as regulatory frameworks continue to evolve at an accelerating pace.