Binding requirements from August 12, 2026

The entry into force of the regulation imposes compliance with the first fundamental requirements:

• Prevention and reduction of packaging mass: Binding criteria for the reduction at source of packaging weight and volume become operational, forcing the design of solutions that reduce the material used to the strict minimum, without compromising product safety.
• Mandatory recyclability criteria: Fundamental design requirements for recycling (Design for Recycling) come into force. All packaging must be formally assessed and classified based on its intrinsic recyclability.
• Restrictions on hazardous substances (PFAS): The ban on placing food-contact packaging containing per- and polyfluoroalkyl substances (PFAS) above permitted thresholds on the market becomes operational.
• Presence of heavy metals: The restriction already provided for by the old directive is integrated into the new regulatory framework, which sets the maximum limit for the sum of concentration levels of lead (Pb), hexavalent chromium (Cr VI), cadmium (Cd), and mercury (Hg) at 100 mg/kg.
• Mandatory Declaration of Conformity (DoC): Manufacturers will have to implement conformity assessment procedures and draw up a DoC for the items placed on the market, certifying compliance with the new environmental and safety standards.

The Roadmap of subsequent deadlines

The August deadline represents the initial watershed of an extremely tight multi-year roadmap:

• By the end of 2028: The obligation to include standardized European symbols on all packaging to facilitate separate waste collection (Harmonized environmental labelling) kicks in.
• January 1, 2030: from this date, the most restrictive targets of the regulation come into force, which include:
  • Recyclability at scale: the obligation to guarantee effective recyclability on an industrial scale for all packaging.
  • Recycled content: the introduction of mandatory minimum quotas of post-consumer recycled material in plastic packaging.
  • Bans on single-use: the banning of specific types of single-use packaging, particularly for formats used in the HoReCa sector.
  • Stop to overpackaging: the imposition of a maximum limit of 50% empty space for packaging, including that intended for e-commerce.

The interpretative framework: Guidelines and FAQs from the Commission

The institutional clarifications that arrived on March 30, 2026, with the Guidelines and FAQs of the European Commission, are currently the main technical reference to resolve application doubts. The most relevant points concern:

• Distinction between Manufacturer and Producer: Institutional clarifications have outlined the boundaries of responsibilities. The Manufacturer (whoever designs or places their brand on the packaging) is responsible for technical compliance and design at the EU level, while the Producer (whoever first places the packaging on the market of a specific State) is responsible for local EPR obligations and costs.
• Scope of packaging application: Precise definition of which specific items fall or do not fall within the scope of application of the regulation, going beyond the purely indicative nature of Annex I.
• PFAS thresholds and exemptions: Operational details on the application of bans for food-contact packaging.

Operational strategies: how to manage the transition now

The approaching deadline requires immediate action from companies on several fronts:

• Integration of requirements into R&D processes: Weight/volume reduction criteria and Design for Recycling must be the starting point of the design process, modifying purchasing flows from the very first stages of eco-design.
• Supply Chain involvement and qualification: It becomes essential to start screening and monitoring the supply chain. Partner companies must be requested to provide the appropriate technical documentation and the structured data flows necessary to guarantee and track the compliance of the final product.
• Creation of the Technical File: It is necessary to promptly structure the technical documentation required by Annex VII of the regulation. This documentary structure constitutes the legal prerequisite and objective evidence supporting the Declaration of Conformity, which the manufacturer is obliged to have and make available to the competent authorities for the necessary checks.

Conclusions

Regulation (EU) 2025/40 marks a point of no return for the entire packaging supply chain.
In a context where sustainability becomes a harmonized and binding legal obligation, regulatory compliance ceases to be a cost and transforms into the fundamental pillar for protecting business and ensuring business continuity in the EU market.

ECHA’s Universal Restriction Proposal (UPR)

The ECHA (European Chemicals Agency) Background Document clarifies the scope of the REACH restriction proposal, officially presented in January 2023 by the authorities of five Member States: Germany, the Netherlands, Denmark, Norway, and Sweden. The goal is to restrict approximately 10,000 PFAS substances, preventing their release throughout the entire product life cycle.
Given the ubiquitous nature of these substances, the global restriction affects a very wide range of industrial sectors:

• Textiles and Clothing: Technical fabrics and water-repellent treatments.
• Electronics and Semiconductors: Critical components for hardware and infrastructure.
• Transport (Automotive and Aerospace): Seals, cables, and hydraulic fluids.
• Energy: Solar panels and hydrogen technologies.
• Consumer Products: Non-stick cookware, cosmetics, and firefighting foams.
• FCM (Food Contact Materials): Barrier treatments for paper and cardboard, plastics, rubbers.

It is important to emphasize that REACH is already intervening with concrete measures on specific subclasses. An example is Regulation (EU) 2024/2462 which limits the use of perfluorohexanoic acid (PFHxA), its salts and related substances (Entry 79 – Annex XVII). From October 10, 2026, the ban on placing on the market will take effect for various applications, including paper and cardboard in contact with food.

The regulatory precedent: Denmark and the Netherlands

It is essential to highlight that for cellulosic FCMs, the restriction path has already begun at the national level. Denmark, a pioneer in this field, introduced a ban on the use of PFAS in paper and cardboard materials in contact with food as early as July 2020. Similarly, the Netherlands implemented specific restrictions in 2022 limiting the use of these substances in paper and cardboard.

Restrictions of Regulation (EU) 2025/40 (PPWR)

While the REACH process continues, the packaging sector already has its limits defined in the new Regulation (EU) 2025/40 (PPWR). Article 5, Paragraph 5, stipulates that starting from August 12, 2026, food contact packaging cannot be placed on the market if it exceeds the following concentration limit values:

• 25 ppb (µg/kg) for individual PFAS measured by targeted analysis.
• 250 ppb (µg/kg) for the sum of measured PFAS.
• 50 ppm (mg/kg) for total PFAS content, including polymeric ones.

The 50 ppm limit serves as a critical threshold for screening. If the total fluorine content exceeds 50 mg/kg, the manufacturer or importer must provide documentary evidence (or second-level analysis) demonstrating whether this value is attributable to PFAS or non-PFAS substances.

Compliance Strategy and Supply Chain Management

Compliance is no longer just a matter of laboratory testing, but of rigorous technical-regulatory management:

• Supplier Audits: Identify intentional addition and the presence of precursors or processing aids (PPA – Polymer Processing Aids).
• Documentary Update: The technical file (Annex VII of the PPWR) must be integrated with objective evidence of compliance.
• Unintentional Contamination: Particular attention should be paid to cellulosic materials and Recommendation (EU) 2019/794 on the risks of migration from cross-contamination or recycled paper.

Conclusions

The transition to “PFAS-free” materials represents a structural change for the entire supply chain. The technical complexity of these substances and their widespread presence necessitate an accurate mapping of materials and constant dialogue with raw material suppliers.
Anticipating the analysis of one’s packaging against the requirements of August 12, 2026, is not only an act of legal compliance but a necessary step to ensure product safety and transparency toward the consumer. In a constantly evolving regulatory context, the correct interpretation of technical data and the constant updating of technical files remain the pillars for effective and conscious risk management.

What Are Microplastics and Why Are They Everywhere

By microplastics (MP), we mean plastic polymer particles with dimensions smaller than 5 millimeters. An even greater concern is posed by nanoplastics, invisible to the naked eye, with dimensions smaller than 100 μm, capable of crossing our body’s protective barriers, including the brain and placenta.

MP are divided into:

• Primary MP: Released directly into the environment (e.g., microbeads in cosmetics, synthetic fibers released from washing clothes, tire wear).
• Secondary MP: Derived from the fragmentation of larger plastic objects, which constitute the majority (up to 81%) of plastic pollution in the oceans.

Their resistance to biodegradation makes them persistent in every environmental matrix: air, soil, drinking water and, consequently, in the food chain. Recent Italian studies have confirmed their presence even in consumer products such as cheeses, highlighting how close the problem has come to our plates.

Reporting Obligations and Pellet Management (Reg. 2025/2365)

The European Union has taken a decisive path to limit the dispersion of microplastics intentionally added to products (as provided for by the REACH restriction). Beyond gradual bans, the focus is now shifting to the transparency and responsibility of producers.

The Reporting Deadline (ECHA)

The crucial point for many companies is the imminent Annual Reporting obligation for intentionally added microplastics:

• Start: The obligation to report environmental data collected in the 2025 calendar year will begin starting from May 31, 2026.
• Platform: Reporting must take place through the ECHA IUCLID platform.
• What to report: Companies must communicate the identity of the polymer, the estimated quantity released into the environment, and any applicable derogations.

In parallel, Regulation (EU) 2025/2365 establishes binding obligations for economic operators to prevent and contain the dispersion of plastic pellets at all stages of the supply chain, reducing microplastic pollution. The provisions will come into force at successive deadlines starting from December 16, 2025, with the main compliance deadlines scheduled for December 17, 2027.

REACH and Microplastics: Classification and Detection for Compliance

To correctly fulfill REACH obligations related to microplastics, it is essential to address two interconnected levels of complexity:

1. Correct Regulatory Classification: The first crucial step is determining if a substance falls under the REACH definition of a polymer and, consequently, the definition of a microplastic subject to restriction, as established by Regulation (EU) 2023/2055 (which introduced restriction 78 in Annex XVII). The application of these decision criteria is complex and requires deep technical-regulatory expertise.
2. Material Analysis and Characterization: In addition to classification, it is indispensable to proceed with analysis for the quantification and identification of the chemical composition of microplastics and nanoplastics. This process requires advanced instrumentation and methodologies. Precise knowledge of the chemical composition of polymers is fundamental for developing targeted and effective mitigation strategies, in line with the environmental protection goals of Regulation 2023/2055.

The complexity of the upcoming deadlines requires timely planning: mapping your polymers and implementing accurate monitoring systems is the first essential step to successfully managing this transition.