Summary

PFAS compliance for food-contact packaging under the EU Packaging and Packaging Waste Regulation (PPWR) should be verified against the exact commercial packaging being placed on the EU market, using evidence that matches the specific legal limit being assessed. A generic “PFAS-free” or “no intentionally added PFAS” declaration cannot establish compliance by itself. From 12 August 2026, Article 5(5) applies three different concentration limits covering individual targeted PFAS, summed targeted PFAS and PFAS including polymeric PFAS. The European Commission's 2026 guidance recommends a stepwise analytical approach beginning with total fluorine screening, followed by further fluorine investigation and TOP analysis where relevant. Approval should focus on method fitness, analytical scope, reporting basis, sample representativeness and whether every result can be traced to the same commercial packaging configuration.

The PPWR Creates Three Different PFAS Compliance Decisions

Under Regulation (EU) 2025/40, food-contact packaging placed on the EU market from 12 August 2026 must not contain PFAS at or above the limits specified in Article 5(5):

• 25 ppb (25 µg/kg) for any individual PFAS measured by targeted PFAS analysis, excluding polymeric PFAS from quantification;
• 250 ppb (250 µg/kg) for the sum of PFAS measured as the sum of targeted PFAS analysis, where applicable with prior degradation of precursors, excluding polymeric PFAS;
• 50 ppm (50 mg/kg) for PFAS including polymeric PFAS.

When total fluorine exceeds 50 mg/kg, Article 5(5) also provides for evidence on the amount of fluorine measured as PFAS or non-PFAS so that the required technical documentation can be prepared.

These are three different evidence questions.

A laboratory report that addresses the individual-PFAS limit does not automatically demonstrate compliance with the polymer-inclusive 50 ppm limit. A broad fluorine result also does not identify which individual PFAS are present.

Quality approval becomes unreliable when these analytical boundaries are collapsed into a single “PFAS passed” conclusion.

Legal Limits and the Commission's Recommended Test Sequence Should Be Kept Separate

The legal limits come from Article 5(5). The analytical sequence currently recommended for enforcement comes from the European Commission's June 2026 PPWR guidance.

The distinction matters because the Commission states that there is currently no harmonised EU methodology for PFAS testing in food-contact packaging. Its guidance recommends a stepwise approach based on current analytical capability rather than establishing one exclusive statutory test method.

Step 1: Total Fluorine Screening

The Commission recommends total fluorine (TF) quantification as the first step.

If TF is below 50 mg/kg, the guidance states that the sample could be considered compliant under the recommended enforcement approach.

This does not make 50 mg/kg a separate legal “total fluorine limit.”

The Article 5(5) threshold is 50 mg/kg PFAS including polymeric PFAS. TF is being used as a broad screening measurement because fluorine can reveal material outside a conventional targeted PFAS panel.

That distinction should remain visible in internal specifications and approval records.

Step 2: Resolve Elevated Fluorine

When TF exceeds 50 mg/kg, the result should not immediately be interpreted as PFAS exceeding the PPWR limit.

The Commission guidance identifies methods such as pyrolysis-GC/MS for investigating whether fluorine is organic or inorganic. Article 5(5) requires appropriate evidence concerning fluorine measured as PFAS or non-PFAS when that information is requested for technical documentation.

The quality question at this stage is:

Has the source and regulatory relevance of the fluorine been adequately resolved?

An unexplained TF result above 50 mg/kg should remain an open approval issue.

At the same time, “organic fluorine” should not be treated as a complete molecular identification of every PFAS present. The analytical conclusion must stay within the capability of the method used.

Step 3: Address the 25 and 250 µg/kg Limits

For the lower targeted limits, the Commission guidance recommends direct TOP — total oxidizable precursors — analysis to check compliance with the 25 µg/kg and 250 µg/kg thresholds.

The legal text itself refers to targeted PFAS analysis and, for the summed threshold, precursor degradation where applicable.

This means an approval file should avoid the simplified statement:

“PPWR requires TOP testing.”

A more accurate conclusion is:

Article 5(5) establishes the concentration limits and analytical boundaries; the Commission currently recommends direct TOP analysis within its enforcement approach for checking the 25 and 250 µg/kg limits.

That distinction reduces the risk of turning regulatory guidance into a requirement that the Regulation itself does not expressly prescribe.

Method Fitness Matters as Much as the Reported Number

Article 35 adds an important quality requirement that can easily be missed when attention stays on the three PFAS thresholds.

For verification of requirements including Article 5, tests, measurements and calculations must use methods that are reliable, accurate and reproducible, take recognised state-of-the-art methods into account, and produce results considered to have low uncertainty.

A result below a regulatory threshold has limited approval value when the laboratory method cannot adequately support a decision at that concentration.

The review should therefore include:

• analytical scope and targeted PFAS list;
• quantification capability relative to the decision being made;
• treatment of precursors where relevant;
• coverage or treatment of polymeric PFAS;
• sample preparation;
• calculation and reporting basis;
• laboratory treatment of uncertainty;
• units and conversion basis;
• identification of the tested packaging.

No universal laboratory LOQ should be invented from the PPWR. The appropriate method must instead be demonstrably fit for the compliance conclusion being drawn.

A result very close to a limit deserves more scrutiny than a simple “< limit” label suggests. Quality teams should examine how measurement uncertainty, quantification capability and reporting conventions affect the decision before converting the analytical result into an unconditional approval.

Check What the Concentration Is Actually Based On

Two reports expressed in µg/kg or mg/kg are not automatically comparable.

Before a result is compared with an Article 5(5) threshold, confirm what the reported mass basis represents.

The tested object may be:

• the complete finished package;
• a paper or polymer substrate;
• one coating layer;
• an adhesive;
• an ink or primer;
• a film;
• a raw material;
• an analytical extract.

A PFAS result for a barrier-coating concentrate cannot silently become a result for the finished food-contact package.

The opposite assumption can also create problems. A low result for one upstream raw material does not demonstrate that no relevant fluorine source enters through inks, adhesives, surface treatments or other converting steps.

The basic approval question should be written explicitly:

Which physical packaging configuration and mass basis does this concentration describe?

If the answer is unclear, direct comparison with the PPWR threshold should be held until the reporting basis is resolved.

A Supplier Declaration Is Supporting Evidence, Not the Final Test Result

Statements such as:

• “PFAS-free”;
• “no intentionally added PFAS”;
• “fluorine-free”;

do not describe the same evidence.

A declaration of no intentional PFAS use may be useful for reviewing formulation knowledge. It does not, by itself, demonstrate that the applicable Article 5(5) concentration limits are met.

The most relevant declaration checks for this page are limited to:

• the exact commercial grade or packaging component;
• the PFAS definition used;
• formulation or product revision;
• manufacturing source where relevant;
• the period covered by the statement.

Broader questions concerning version control, supplier declarations and PFAS data governance are better treated separately under PFAS product tracking and change control.

For PPWR approval, the declaration should help explain the analytical evidence. It should not replace it.

Development Samples, Pilot Runs and Commercial Packaging Carry Different Risks

One of the easiest ways to create a technically correct but commercially weak approval file is to test a sample that does not represent the packaging ultimately placed on the market.

Development Sample

A development sample can determine whether the proposed material route is worth continuing.

Its main risks are incomplete converting history, laboratory-applied coatings, non-commercial cure conditions, provisional raw materials and a formulation that may still change.

A passing development sample supports continued evaluation. It does not automatically qualify future production.

Pilot or Trial Production

Pilot production is more useful for identifying fluorine sources introduced by the real converting process.

At this stage, review whether commercial:

• substrates;
• coatings;
• adhesives;
• inks;
• process aids;
• heat-seal layers;
• production conditions

match the intended final construction.

A pilot result becomes weak evidence if the formulation or converting route changes before launch.

Commercial Batch

Commercial approval should be tied to the production configuration actually being placed on the market.

The risk shifts from initial material selection toward equivalence and change control:

• Is the tested structure the current structure?
• Are commercial components equivalent to those represented in the test?
• Has a coating, ink, adhesive or production source changed?
• Does the technical documentation still represent series production?

Article 15 requires manufacturers to maintain conformity in series production and reassess where relevant changes could affect conformity.

A historical passing result should not remain permanently attached to a packaging code after changes that could alter the PFAS evidence basis.

PPWR PFAS Approval Decision Table

The table is deliberately structured around decisions rather than documents.

Having a TF report, a declaration and a targeted PFAS report is not sufficient when those documents answer different questions or refer to different versions of the packaging.

Migration Testing Answers a Different Food-Contact Question

Existing food-contact approval files often contain migration testing, which can make migration reports appear to be convenient PFAS compliance evidence.

The measurement objective is different.

Migration testing evaluates transfer under specified conditions. Article 5(5) establishes concentration limits for PFAS contained in the packaging. A satisfactory migration result therefore does not directly replace the concentration evidence needed for the PPWR PFAS assessment.

Migration data may still be required under the broader EU food-contact framework.

For PFAS approval under Article 5(5), use each test only for the conclusion it was designed to support.

Technical Documentation Should Show the Entire Approval Chain

Article 5(6) requires compliance with the PFAS requirements to be demonstrated in technical documentation prepared in accordance with Annex VII.

The PPWR also requires conformity assessment before packaging is placed on the market, followed by the EU Declaration of Conformity where conformity has been demonstrated. Suppliers must provide information and documentation necessary for manufacturers to demonstrate packaging and packaging-material conformity.

For PFAS review, the useful chain is:

commercial packaging identity → current construction → analytical sample → method → reporting basis → result → applicable PPWR limit → conformity decision

This sequence is more useful than counting the number of certificates in the file.

A laboratory report may be analytically sound and still be insufficient for approval because its sample cannot be connected to the commercial package.

A Major Approval Risk Is the Gap Between Analytical Evidence and the Commercial Package

Industry discussion around PPWR PFAS compliance naturally concentrates on analytical technique: total fluorine, TOP, targeted PFAS panels and methods for resolving fluorine.

Those questions matter. The less visible risk is the connection between what the supplier knows, what the laboratory measured and what the company intends to place on the EU market.

My assessment is that PPWR PFAS verification is strongest when quality teams deliberately keep these three questions separate:

What does the supply chain know about the composition?

A declaration, formulation review or component statement can support this question.

What did the laboratory actually measure?

The answer depends on analyte scope, sample preparation, method fitness, mass basis and uncertainty.

Which commercial packaging does the conformity decision cover?

This requires identity, configuration, production equivalence and controlled documentation.

Weak approval files often arise when evidence from one layer is used to answer another. A supplier statement becomes a substitute for concentration testing. A coating test becomes a finished-package conclusion. A development result survives several formulation revisions without reassessment.

For R&D, quality, production and procurement teams, the practical implication is straightforward: requesting more certificates is less useful than identifying which unresolved decision each additional test or document must close.

When PFAS Approval Should Remain Open

The final decision can follow a short sequence.

Confirm that the packaging falls within the Article 5(5) food-contact scope and identify the exact commercial construction.

Map each of the three PFAS limits to evidence capable of addressing that limit.

Verify that the analytical method, reporting basis and quantification capability are suitable for the intended decision.

Where TF exceeds 50 mg/kg, resolve the fluorine evidence rather than assuming that all measured fluorine represents PFAS.

Check whether targeted and precursor-related evidence supports the 25 and 250 µg/kg decisions, and whether polymeric PFAS has been adequately addressed for the 50 mg/kg boundary.

Reconcile the tested sample with the development, pilot and commercial packaging versions.

Approval should remain open when:

• the tested article or mass basis is unclear;
• the method cannot support the regulatory decision being claimed;
• elevated fluorine remains unexplained;
• targeted PFAS or precursor scope is insufficiently defined;
• polymeric PFAS coverage is unresolved;
• different reports relate to different packaging revisions;
• a commercial material or converting change has invalidated the evidence basis.

Projects replacing fluorinated barrier systems can treat material selection as a separate qualification task; PFAS-free barrier coating selection addresses that decision independently from PPWR evidence review.

For material and documentation inquiries related to PFAS-free packaging projects, provide the packaging component or raw material, intended food-contact use, target market, current specification, available PFAS documentation, sample requirement and relevant commercial configuration through the RFQ. ChemicalCell can discuss relevant material specifications, samples and available supplier documentation without treating a raw-material review as a substitute for the packaging manufacturer's PPWR conformity assessment.