The manufacture and use of packaging across all supply chains are covered by Regulation (EU) 2025/40, which will enter into force on 12 August 2026 and aims to reduce the environmental impact of packaging, promote its recycling and reuse, and ensure a sustainable and harmonised European market. The transposition of Directive (EU) 2020/2184 via Legislative Decree No. 102 of 19 June 2025 updates the quality and safety requirements for drinking water. The measure amends Legislative Decree 18/2023 and introduces stricter limits for certain substances, whilst also redefining the requirements for materials in contact with drinking water. We interviewed Marco Pasqualini, Management Consultant, Trainer and Lead Auditor of Business Management Systems, on these issues.
You have been working in the sector as a management consultant for over thirty years now; how is your business organised today?
I have held roles of increasing responsibility and managerial scope within the packaging industry and related services, before specialising in regulatory and systems consultancy. I am a lead auditor for food safety and quality management systems, as well as for product standards relating to materials and articles intended to come into contact with food. I have published handouts and articles, contributed to the drafting of numerous application guidelines, and am involved in various working groups at the Italian Packaging Institute and within the food sector of AICQ.
What are your organisation’s current objectives?
We provide management consultancy services in the areas of quality management systems, risk management, regulatory compliance and training, with a particular focus on food safety, materials in contact with food, drinking water, sustainability and the environment. Our clients are primarily food manufacturers, large-scale retailers, food packaging manufacturers, and producers of food industry machinery and equipment. We establish partnerships to support technical, regulatory and systemic areas, building strong relationships with national and multinational companies, public and private bodies, as well as regulatory authorities. We support specialist training programmes with qualified instructors and conduct audits or assisted audits. Our work is characterised by curiosity, passion, in-depth analysis and openness to new perspectives. To tackle the challenges of the sector, we dedicate more than 10% of our time to study aimed at continuous professional development.
PACKAGING AND PACKAGING WASTE REGULATION
In 2025, the PPWR – the ‘Packaging and Packaging Waste Regulation’ – came into force. What are the obligations for businesses?
The European Union assigns businesses a central role in pursuing sustainable development, following the principles of the UN 2030 Agenda and the objectives of the European Green Deal. These tools guide the transition to a competitive, responsible, and inclusive economy, with particular attention to the environment and future generations. To achieve this vision, the European Union has developed an integrated regulatory framework aimed at ensuring coordinated management of the most significant risk areas, considering the needs and expectations of various stakeholders. Directive 62/1994/EC on packaging and packaging waste had given rise to conflicting interpretations and unequal treatment among operators in the single market. The European Commission has highlighted that approximately 50% of virgin cellulose and 40% of virgin plastics introduced into the EU market are destined for the packaging sector. Packaging production is growing faster than the Union’s GDP, accounting for almost 40% of municipal solid waste. In this context, the companies involved were invited to participate in the development of a new Regulation aimed at harmonizing the sector’s legislation. During consultations between the European Union and stakeholders, including companies, they expressed specific requests: the need for a stable and harmonized regulatory framework to ensure investment security, fair conditions to incentivize the production of sustainable packaging, and an efficient recycling system capable of improving the quality of secondary raw materials. To address these needs, the EU enacted Regulation No. 40/2025/EU (PPWR), a measure aimed at systematically addressing the challenges facing the packaging sector, in line with the companies’ objectives. The Regulation introduces uniform rules for every stage of the packaging life cycle, from environmental sustainability to labeling requirements, while maintaining principles such as extended producer responsibility and the prevention of packaging waste, ultimately replacing Directive No. 62/1994/EC. The PPWR requires companies to systematically document the actions taken to ensure and monitor compliance with essential sustainability requirements for packaging and waste in the EU.
Why does the PPWR leave plenty of room for interpretation?
The Commission has decided that a gradual tightening of the sustainability criteria for packaging is in line with the principle of proportionality. With this in mind, the PPWR introduces a progressive increase in targets and requirements, covering aspects such as the sustainability of recyclable packaging, derogations regarding the concentration limits of harmful substances in specific packaging materials, as well as other exceptions relating to the adoption of the new provisions. During the transition to the new targets, in order to address complex challenges in collaboration with stakeholders and in light of the latest scientific developments, the Commission has committed to publishing specific delegated acts or to acting through subsequent implementing acts. It should be emphasised that there is no regulatory gap. Indeed, until the publication of these acts or the adoption of new harmonised sectoral European technical standards, existing national legislation will continue to apply. The rules currently in force in Italy remain applicable as interpreted with reference to the PPWR in accordance with the correlation table set out in Annex XIII of the new Regulation.
What impact will the PPWR have on business operations?
This is a significant undertaking for all supply chains. All stakeholders in the relevant supply chains (producers, manufacturers, importers, and users of packaging) have specific responsibilities. Each party has an active role in managing the mandatory traceability of packaging and in preparing the new Declarations of Conformity. The manufacturer has the most onerous obligations; this role is defined by the PPWR as anyone who produces, or has designed or manufactured, packaging or packaged products under their own name or trademark, thus potentially being a producer or user of a product that owns the packaging design. The manufacturer is responsible for compliance with the essential environmental requirements established in Articles 5-11, fulfilling the labeling requirements set forth in Article 12, preparing a technical file in accordance with the provisions of Annex VII, and systematically assessing conformity to ensure that products adhere to these standards with a production system that ensures that series production remains compliant. Once these conditions have been verified, the manufacturer issues a declaration of conformity, identifying the product by a batch number. It also establishes procedures for managing any withdrawals or recalls, indicating the contact point for this purpose.
Do companies already have explanatory documents they can rely on?
The Italian Packaging Institute’s Guidelines for the Application of PPWR in Businesses will be published in the coming months. This document, developed with the input of all supply chains and stakeholders involved, will have a practical and operational focus. As the coordinator of this activity, I invite interested organizations to contact me to contribute to the project with useful and constructive contributions.
HIGH PERCENTAGES OF RECYCLED MATERIAL
Many fear that the high proportion of recycled raw materials required by the PPWR could lead to an imbalance between supply and demand, forcing manufacturers to import secondary raw materials from non-EU countries, thereby driving up costs. Are these concerns justified?
The Commission bases its findings on market data provided by the Extended Producer Responsibility (EPR) schemes in the Member States. This data indicates that the capacity for recycling packaging waste in the European Union is not being fully utilised: one third of packaging waste is not being recycled properly, whilst the volume of such waste is on the rise. This is largely attributable to a lack of technological innovation, insufficient outlet markets and the shortcomings of a fragmented and non-harmonised regulatory framework. These factors limit the economic viability of recycling activities and hinder the investment needed to develop advanced technologies and efficient logistics infrastructure. It therefore becomes difficult to ensure collection, sorting and recycling that produce high-quality secondary raw materials. The PPWR Regulation addresses these critical issues. It should not be forgotten, in this context, that importers from non-EU markets are subject to the same obligations as producers. Anyone placing products on the European single market must ensure that they comply with EU regulations. The same criterion applies to any imports of secondary raw materials and waste.
How might the high recyclability rates and recycled content requirements set out in the PPWR affect the safety of food packaging?
They can’t. The PPWR and other industry standards establish that packaging sustainability requirements apply without prejudice to other EU regulations on packaging, such as those concerning safety, quality, health protection, hygiene of packaged products, and transportation. In the event of a conflict between standards, health protection takes precedence over environmental sustainability requirements. Companies must, however, comply with the required requirements and justify any necessary exclusions.
Other issues raised by the PPWR include the reuse of pallet wrapping, the ban on single-use containers for certain products offered by the HoReCa sector, and the requirement to make tea bags and infusions and coffee pods compostable. Isn’t there a risk of sacrificing part of food safety for entirely residual environmental benefits?
I don’t think so. Here too, the priority is ensuring consumer safety. The responsibility of the manufacturer of materials or objects intended to come into contact with food remains unchanged. The MOCA technical field is highly regulated, and every material, including secondary raw materials, must meet rigorous purity standards and have a well-defined composition. These materials must be verified for compliance, including assessments of inertness (including sensory), chemical composition checks, and safety assessments through specific migration tests in predefined simulants. These tests identify constituents or degradation products that are potentially hazardous to consumer health.
The EU tends to penalize plastics, even though it’s not always easy and safe to replace plastic with alternative materials in the food sector. Do you share this view?
Packaging is a key element for progress; it makes products available in space and time, while meeting required safety requirements. The choice of packaging depends on the specific needs of the product. Therefore, there is no single ideal packaging or material, but rather the design solution that best meets a given need. Data provided by management systems and Member States confirm this premise. They indicate that by weight, plastic packaging waste accounts for approximately half of total paper and cardboard packaging waste, yet only 40% of plastic packaging is recycled, less than half compared to 87% for paper and cardboard packaging. The worst results in the EU are for wooden packaging, which is subject to specific regulations and part of a supply chain that uses a raw material with a lower environmental impact. Plastic is therefore the focus of particular attention, as it is characterized by ambitious quantitative targets aimed at bringing it into line with the recycling averages of other packaging materials.
By 2028, environmental labeling for packaging will be harmonized. Are there already indications of this?
The European Union’s Joint Research Centre (JRC) has developed a background document for the EU Commission, consisting of a factual summary report. The document is the result of a targeted consultation with stakeholders regarding harmonized EU labels for separate waste collection, within the framework of the Packaging and Packaging Waste Regulation. The report contains a preliminary proposal for further development. Until 2028, all packaging placed on the EU market must continue to be labeled with a two-level minimum information requirement: on the one hand, to facilitate the recovery system, the application of the alphanumeric labeling established by Decision 129/1997/EC is required; on the other hand, to allow consumers to dispose of them correctly, indications based on existing EN standards, such as UNI EN ISO 14021, are provided. Any further labelling or environmental declaration will be subject to the provisions of Directive (EU) 2024/825, which introduces specific harmonised rules to combat unfair or misleading commercial practices towards consumers, including those resulting from misleading environmental claims (greenwashing).
THE NEW WATER DECREE
2025 also saw the approval of Legislative Decree 102/2025 on the quality of water intended for human consumption, which updates and supplements Legislative Decree 18/2023, implementing Directive (EU) 2020/2184 (Drinking Water Directive) to protect human health. What changes does this have for water managers and for the safety of water used by the food industry?
The decree introduces significant regulatory innovations, particularly regarding materials and articles intended to come into contact with water throughout its entire lifecycle: collection, treatment, distribution, and tap delivery. The Drinking Water Directive, reformulated in 2021, increases the quality standards of water intended for human consumption, with particular attention to emerging pollutants, such as PFAS and microplastics. It also promotes regulatory harmonization for materials and products used in contact with water. Water is considered a public good of strategic importance, managed through concessions granted to drinking water operators. The hygiene, health, and compliance requirements for materials and products intended to come into contact with drinking water were defined and consolidated with the publication of the minimum standards in the Official Journal of the European Union in April 2024. These detailed standards are divided into three implementing decisions and three delegated regulations.
Are there any new mandatory requirements?
The new harmonized regulatory framework introduces mandatory requirements for product and process compliance, involving drinking water operators, including internal distribution operators (GIDI), responsible for drinking water distribution and treatment plants within private companies, and companies operating in the sector of materials and objects intended to come into contact with drinking water (MOCAP). This latter technical sector includes, for example, manufacturers of cementitious materials, rubber or metal alloy pipes, valves, tanks, filtration systems, and taps. From December 2026, all these supply chains will have to comply with new regulatory requirements relating to MOCAP compliance. The new provisions establish methods and rules for various aspects: the creation and management of a positive list of authorised starting substances, compositions, and constituents for the manufacture of materials and products intended to come into contact with drinking water for human use (Decision (EU) 2024/367); the definition of methodologies for testing and approving starting substances, compositions, and constituents to be included in the European positive lists (Decision (EU) 2024/365); the determination of methodologies for testing and approving final materials used in products intended to come into contact with drinking water (Decision (EU) 2024/368); the procedure for including new substances in the positive list of substances, compositions, or constituents suitable for the manufacture of materials or products in contact with drinking water (Regulation (EU) 2024/369); The definition of product conformity assessment procedures and the rules for designating assessment bodies (Regulation (EU) 2024/370); the introduction of harmonized specifications for the marking of products intended for contact with drinking water (Regulation (EU) 2024/371). Companies in the sector must act quickly to understand the new regulatory framework and organize themselves to ensure the compliance of materials and products with the introduced provisions. At the same time, it will be necessary to qualify and monitor suppliers to ensure their compliance with the new EU regulations. Implementation will begin on December 31, 2026. We are ready.
