EU Packaging Regulation 2025/40 Is Now Applicable: What It Means for Cosmetics, Food and Pharma

On 12 August 2026, the way packaging is regulated across the European Union changed at the root. Regulation (EU) 2025/40, known as the Packaging and Packaging Waste Regulation or PPWR, became applicable and began replacing Directive 94/62/EC, the framework that had governed EU packaging since 1994. For any company that places packaging on the EU market, whether a cosmetics brand, a food manufacturer or a pharmaceutical exporter, this is not a minor labelling update. It is a shift from a patchwork of national rules to a single, directly binding rulebook.

For Canadian and other non-EU exporters the change carries a sting in the tail. The new definition of a producer is broad enough to capture importers and, in some cases, distributors, which means obligations can land on parties that never physically made a box or a bottle. This article explains what the PPWR requires from 12 August 2026, what comes later, and what companies selling into the EU should be doing now.

Executive summary

The PPWR is a regulation, not a directive, so it applies directly in all 27 Member States without national transposition. Most of its provisions became applicable on 12 August 2026, replacing Directive 94/62/EC. It sets harmonised rules on packaging design, restricted substances, recyclability, minimisation and labelling, and it introduces producer registration and extended producer responsibility with a deliberately broad definition of who counts as a producer.

• Regulation (EU) 2025/40 entered into force on 11 February 2025 and most provisions apply from 12 August 2026.
• Article 5 restricts substances in packaging, including a combined limit on lead, cadmium, mercury and hexavalent chromium, plus limits on PFAS in food-contact packaging.
• All packaging placed on the market must be recyclable, and packaging must be minimised to what is necessary.
• Harmonised labelling, producer registration and extended producer responsibility apply, with several later deadlines in 2030 for recycled content and format bans.
• The producer definition is broad. Importers and some distributors can be producers, so non-EU exporters must check where the obligation actually falls.

What is the PPWR?

The PPWR is Regulation (EU) 2025/40 on packaging and packaging waste. It was published in the Official Journal in December 2024, entered into force on 11 February 2025, and most of its provisions became applicable on 12 August 2026. From that date it replaces Directive 94/62/EC, although a limited number of rules continue to apply during the transition. Because it is a regulation, it takes effect directly in every Member State without each country writing its own version.

The aim is to cut packaging waste and make all packaging recyclable, while ending the fragmented national rules that made EU-wide packaging compliance a country-by-country exercise. The scope is wide. It covers primary, secondary and transport packaging, e-commerce packaging, and even items many companies never thought of as packaging, such as sticky labels affixed to fruit and vegetables and the permeable bags used for tea and coffee.

Why a regulation replacing a directive matters

Under the old directive, each Member State transposed the rules into national law, so requirements and enforcement varied across the bloc. A regulation removes that discretion. The same text binds a company in Germany, France and Ireland in the same way on the same date. For compliance teams this cuts both ways: one rulebook is simpler to follow, but a single mistake in packaging design now has EU-wide consequences rather than a national one.

This is the same direct-effect logic the EU has applied elsewhere in its recent regulatory overhauls, including the pharmaceutical space we cover in our guide to the revised EU variations framework. The table below sets out the practical differences between the old directive and the new regulation.

Key requirements from 12 August 2026

The PPWR mixes obligations that apply immediately with others phased in later. From 12 August 2026 the core design, substance, minimisation and labelling duties apply, along with producer registration and extended producer responsibility. Recycled-content minimums and certain format bans arrive from 1 January 2030. Knowing which deadline attaches to which obligation is the first step in a realistic implementation plan.

Restricted substances: heavy metals and PFAS

Article 5 is the provision most likely to force a material change. It caps the sum of lead, cadmium, mercury and hexavalent chromium at 100 mg/kg across all packaging, and it introduces limits on per- and polyfluoroalkyl substances, known as PFAS, in food-contact packaging. For food and cosmetics companies that use coated papers, moulded fibre or certain barrier materials, this is a supply-chain and specification question that has to be answered before product ships.

The compliance discipline here is familiar to anyone who manages container closure systems, which we discuss in our review of the FDA container closure systems draft guidance. You need declarations and documentation from your material suppliers, you need to confirm that what is in your packaging actually meets the limits, and you need a record you can produce on request. Under the PPWR the manufacturer of the packaging or packaged product must carry out a conformity assessment and draw up a declaration of conformity, so the mechanics of product regulation are now being applied to packaging itself.

Labelling, the producer register and extended producer responsibility

The PPWR introduces the first harmonised EU packaging labelling. Packaging must carry material-composition information through standardised pictograms, defined by Commission implementing acts, and may also carry a QR code that tells consumers how to sort each component. Reusable packaging must be labelled as reusable. Separately, producers must register in a national register of producers and take on extended producer responsibility, which means financial contributions toward the cost of managing packaging waste.

Because each Member State keeps its own register, a company that sells across the bloc may need to register in several countries, or all of them, depending on where it first makes packaging available. Manufacturers must also mark packaging with an identifying type, batch or serial number and provide contact details, which brings packaging into line with the traceability expectations already applied to many regulated products.

Who counts as a producer, and why non-EU companies are caught

The PPWR uses a broad definition of producer. It covers not only the company that makes the packaging, but also the importer and, in various scenarios, the distributor. A party that makes packaging available in a Member State for the first time, or that unpacks packaged products in a Member State without being the end user, can be a producer with full registration and extended producer responsibility obligations. That is how the rules reach beyond EU manufacturers.

For a Canadian cosmetics or food brand exporting into the EU, this means the obligation may sit with your EU importer or EU-based entity, but the documentation, conformity and design responsibility flows back to you. Importers cannot place non-compliant packaging on the market, and they will demand the evidence from you before they will. This is the packaging counterpart to the market-access work we describe for cosmetics GMP and ISO 22716: the rules apply wherever your product lands, and a clean file is what keeps your goods moving.

What non-EU companies should do now

The practical first move is a packaging portfolio review: map every pack format you sell into the EU against the Article 5, 6, 10 and 12 requirements, and identify where obligations fall on you versus your EU importer. From there, gather supplier declarations, plan any material substitutions early, and build the registration and labelling changes into your production schedule. Getting packaging right on the line is its own discipline, as we show in our look at packaging line clearance, and a PPWR change touches artwork, specification and changeover control at once.

PPWR compliance checklist

Use this checklist to test your packaging against the PPWR. Any item you cannot tick is a gap to close.

• You have mapped every pack format sold into the EU and identified whether you, your importer or your distributor is the producer for each.
• You hold supplier declarations confirming the combined heavy-metal limit of 100 mg/kg and, for food-contact packaging, the PFAS limits under Article 5.
• Each packaging item is recyclable within the meaning of Article 6, and you can show the design basis for that claim.
• Packaging weight, volume and empty space have been reviewed against the Article 10 minimisation duty.
• Artwork carries the harmonised material pictograms and disposal information, and reusable packaging is labelled as reusable.
• You have registered in the producer register of each Member State where you are a producer, and you report the quantities placed on the market.
• A conformity assessment and declaration of conformity exist for your packaging, with the supporting technical file.
• You have a 2030 plan for recycled-content minimums under Article 7 and the format bans under Article 25 and Annex V.

Common mistakes

• Assuming a directive-era national compliance file still covers you, when the regulation now binds directly and adds new duties.
• Believing that because you do not manufacture packaging you are not a producer. Importers and some distributors are producers under the PPWR.
• Treating the PFAS and heavy-metal limits as a labelling issue rather than a material and supplier-specification issue that may need substitution.
• Registering in one Member State and assuming it covers the whole EU, when each country keeps its own producer register.
• Leaving recycled-content and format changes to 2029, when material and supplier redesign takes far longer than a year.

Frequently asked questions

When does the EU Packaging Regulation apply?

Regulation (EU) 2025/40 entered into force on 11 February 2025, and most of its provisions became applicable on 12 August 2026, replacing Directive 94/62/EC. Some obligations, such as minimum recycled content and certain single-use format bans, apply later, from 1 January 2030.

Does the PPWR apply to non-EU companies?

Yes, in effect. Packaging placed on the EU market must comply regardless of where it was made. The producer definition captures importers and some distributors, so a non-EU exporter's EU importer will require compliant packaging and documentation, and the design and conformity responsibility flows back to the exporter.

What does the PPWR say about PFAS?

Article 5 introduces limits on per- and polyfluoroalkyl substances in food-contact packaging, alongside a combined limit of 100 mg/kg for lead, cadmium, mercury and hexavalent chromium. Companies using coated or barrier materials should confirm compliance with their suppliers before shipping.

Is the PPWR a regulation or a directive, and why does it matter?

It is a regulation. Unlike the directive it replaces, it applies directly in every Member State without national transposition, so the same rules bind companies across the EU on the same date. That removes country-by-country variation but also means a design error has EU-wide consequences.

Do I need to register in every EU country?

Each Member State maintains its own register of producers. You must register where you are a producer, which may be one country or several depending on where you first make packaging available. Companies selling across the bloc should check their obligations in each market rather than assume one registration suffices.

What are the main 2030 deadlines under the PPWR?

From 1 January 2030, plastic parts of packaging must contain a minimum percentage of recycled content, between 10% and 35% depending on the packaging type, and certain single-use plastic packaging formats listed in Annex V are banned. These require material and supply-chain planning well before the deadline.

How MFLRC can help

MF License and Regulatory Consultants helps cosmetics, food and pharmaceutical companies place compliant packaging on the EU market. Through our regulatory affairs, licensing and import and export services, we run packaging portfolio gap assessments against the PPWR, map where producer obligations fall, review supplier declarations for the Article 5 substance limits, and build the conformity documentation, labelling changes and registration plan you need. We support food and beverage and consumer-goods exporters through the full change, from specification to declaration of conformity.

If you place packaging on the EU market and are not sure whether you are a producer under the PPWR, that uncertainty is itself the risk. We map your obligations and build the file that keeps your product moving.

Conclusion

The PPWR is one of the most far-reaching packaging changes the EU has made in three decades. It replaces a flexible directive with a binding regulation, sets hard limits on what packaging can contain, and reaches non-EU companies through a broad producer definition. Most of it applies now, from 12 August 2026, with the heavier material changes landing in 2030. The companies that treat the 2030 deadlines as distant risk being caught short, because packaging redesign, supplier substitution and multi-country registration take time. A structured gap assessment today is the difference between a controlled transition and a scramble at the border.

Sources and references

• Regulation (EU) 2025/40 on packaging and packaging waste, EUR-Lex (Official Journal)
• Packaging and packaging waste, summary of EU legislation, EUR-Lex
• Packaging waste, European Commission, Environment