PFAS Compliance Guide: Technical Analysis for Product Compliance Specialists

As a product compliance specialist, you face a pivotal challenge with the rapidly evolving PFAS regulatory landscape. This technical guide unpacks the specific compliance requirements, testing protocols, and documentation needs to maintain market access as these "forever chemicals" come under unprecedented regulatory scrutiny.

Regulatory framework analysis

REACH comprehensive restriction proposal

The joint proposal from Germany, Netherlands, Denmark, Sweden, and Norway represents the most expansive chemical restriction in REACH history. For compliance specialists, several critical aspects require attention:

Current status:

• Consultation yielded 5,600 comments, highlighting previously unaddressed sectors
• ECHA's scientific committees (RAC and SEAC) are developing opinions
• Provisional conclusions reached for consumer mixtures, cosmetics, ski wax, metal plating, and petroleum/mining
• Assessment ongoing for industrial applications (batteries, fuel cells, medical devices, semiconductors)
• Draft legislation expected late 2025

Compliance implications:

• Affects approximately 10,000 PFAS substances
• Prohibition of manufacture, use, and marketing with potential derogations
• Substance-specific concentration limits likely
• Potentially different enforcement timelines for different sectors
• Testing and documentation requirements expected to be substantial

Packaging and Packaging Waste Regulation (PPWR)

Effective 11 February 2025 with implementation by 11 August 2026, this regulation establishes precise analytical thresholds:

Specific limit values:

• 25 parts per billion (ppb) for individual targeted PFAS
• 250 ppb for sum of targeted PFAS measured
• 50 parts per million (ppm) for total PFAS including polymeric PFAS

Analytical considerations:

• Detection limits will challenge standard analytical techniques
• Targeted PFAS list requires identification of specific compounds
• Total PFAS analysis includes polymeric forms, requiring specialized techniques
• Laboratory capability assessment essential for compliance validation

PFHxA Restriction

Coming into effect 10 October 2026, with variable transition periods of 18 months to 5 years, this targeted restriction has differentiated requirements:

Scope parameters:

• Limits perfluorohexanoic acid, its salts and related substances
• 25ppb for PFHxA individually, 1000ppb for related substances
• Applies to specific product categories: consumer textiles, food packaging, consumer mixtures, cosmetics, firefighting foams
• Excludes semiconductors, batteries, fuel cells for green hydrogen

Compliance timeline:

• Different transition periods for different applications
• Earliest restrictions apply to readily substitutable uses
• Technical documentation must demonstrate necessity for extended transition period products

French national ban

Effective 27 February 2025, with broader textile restrictions by 2030:

Product categories:

• Cosmetics
• Ski waxes
• Clothing and footwear
• Waterproofing agents
• All textiles (by 2030) with limited essential use exceptions

Market access implications:

• Non-compliance means immediate market withdrawal from France
• No transitional periods for initial categories
• Compliance documentation must be France-specific
• Essential use applications require justification documentation

Analytical testing protocols for compliance validation

Current analytical challenges

PFAS compliance presents unique analytical complexities:

• Ultra-low detection limits (parts per billion)
• Thousands of PFAS compounds with varying structures
• Matrix effects in complex products
• Limited standardized methods
• Variable laboratory capabilities

Recommended testing approach

1. Total Organic Fluorine (TOF) screening

• Combustion Ion Chromatography (CIC) for initial screening
• Detects both known and unknown PFAS
• Less expensive than targeted analysis
• Can establish "fluorine-free" status at higher detection limits
• Not sufficient for precise regulatory limits

2. Targeted PFAS analysis

• Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)
• Identifies and quantifies specific PFAS compounds
• Required for compliance with substance-specific limits
• Must include regulated PFAS relevant to your products
• Method detection limits must achieve regulatory thresholds

3. Total Oxidizable Precursor (TOP) assay

• Converts PFAS precursors to measurable terminal compounds
• Captures transformation products not detected in standard analysis
• Increasingly referenced in regulatory frameworks
• Provides more comprehensive PFAS assessment

Laboratory selection criteria

When selecting analytical partners, evaluate:

• Accreditation for PFAS testing (ISO 17025)
• Demonstrated ability to achieve required detection limits
• Experience with your specific product matrices
• Participation in proficiency testing programs
• Clear reporting with uncertainty measurements
• Capability to provide legally defensible results

Documentation requirements for market access

Technical documentation file

Prepare a PFAS-specific technical file containing:

• Material composition declarations from suppliers
• Analytical test reports from accredited laboratories
• List of PFAS substances searched for in analysis
• Method detection limits and laboratory certifications
• Supplier certifications of PFAS-free status
• Documentation of alternatives assessment
• Risk assessment for any PFAS used under derogation

Supply chain management tools

Standardized supplier questionnaire

Create a PFAS-specific supplier questionnaire covering:

• Intentionally added PFAS in materials
• PFAS used in manufacturing processes
• Known impurities or contamination risks
• Analytical evidence of PFAS content
• Alternative materials development roadmap

Contractual requirements

Update supplier agreements to include:

• Maximum PFAS content specifications
• Testing and certification requirements
• Change notification requirements
• Compliance representations and warranties
• Indemnification for non-compliance

Material declaration standards

Utilize standardized formats:

• IEC 62474 for electrical/electronic products
• IMDS for automotive applications
• BOMcheck for cross-industry applications
• Adapt to include specific PFAS declarations

Compliance risk assessment methodology

Product portfolio screening

Develop a risk-based approach to your product portfolio:

High-risk products (prioritize for immediate action)

• Products with known PFAS content
• Applications specifically named in regulations
• Products targeting vulnerable populations
• High-volume or flagship products
• Products for French market (earliest deadline)

Medium-risk products

• Products with uncertain PFAS status
• Products from suppliers with limited transparency
• Applications similar to regulated categories
• Products with complex supply chains

Lower-risk products

• Products with documented PFAS-free status
• Simple products with well-characterized supply chains
• Products outside named regulatory categories
• Products with established alternatives

Risk mitigation strategies

1. Testing strategy

• Complete testing for high-risk products
• Screening tests for medium-risk products
• Documentation review for lower-risk products
• Regular monitoring for all categories

2. Reformulation prioritization

• Identify products requiring immediate reformulation
• Establish technical requirements for alternatives
• Develop compliance timeline aligned with regulations
• Create transition plan with staged implementation

3. Regulatory monitoring

• Establish alerts for ECHA opinion publications
• Track member state implementations
• Monitor enforcement activities
• Participate in industry associations addressing PFAS

Compliance timeline and milestone planning

Critical dates for compliance planning

Recommended implementation roadmap

Q2 2025:

• Complete PFAS inventory across product portfolio
• Establish testing protocols with analytical partners
• Develop supplier communication strategy
• Create technical documentation template

Q3-Q4 2025:

• Complete high-risk product testing
• Initiate reformulation of non-compliant products
• Prepare for 2026 implementation deadlines
• Update compliance documentation system

2026:

• Implement packaging compliance for PPWR
• Complete transition for PFHxA-affected products
• Establish monitoring program for compliance
• Prepare for longer-term transition deadlines

Derogation application process

For products that cannot be reformulated within regulatory timelines, preparation for derogation applications will be critical:

Documentation requirements

• Technical impossibility demonstration
• Alternatives assessment with performance gap analysis
• Socio-economic impact analysis
• Emission minimization plan
• Time-bound substitution roadmap

Application strategy

• Identify truly critical uses without alternatives
• Gather performance data demonstrating necessity
• Document research efforts toward alternatives
• Prepare for public consultation defense
• Consider industry consortium approaches

International compliance considerations

While primarily focused on EU regulations, compliance specialists must consider:

• UK REACH divergence possibilities
• US EPA regulations under TSCA
• Nordic countries' accelerated restrictions
• California and other state-level restrictions
• Global harmonization efforts (SAICM)

Technical compliance resources

Analytical methods

• ASTM D7968: Standard Test Method for Determination of Perfluorinated Compounds in Soil
• CEN/TS 15968: Determination of PFOS in selected articles
• EPA Method 537.1: PFAS in Drinking Water
• EN 17497: PFAS in textiles

Industry guidance

• OECD Portal on PFAS
• ECHA guidance on PFAS restriction
• EUROFINS PFAS Testing Capabilities Guide
• SGS PFAS Compliance Solutions

Conclusion

As a product compliance specialist, your role in navigating PFAS regulations is pivotal to maintaining market access. By systematically addressing the analytical, documentation, and risk management aspects outlined in this guide, you can develop a robust compliance strategy that protects your company while supporting the transition to safer alternatives.

This evolving regulatory landscape demands vigilance, with regular reassessment as final opinions and legislation emerge. Companies that establish comprehensive compliance programs now will be best positioned to manage the implementation deadlines ahead with minimal market disruption.

Source: This technical analysis is based on regulatory information regarding PFAS restrictions in the European Union and France.