The Packaging and Packaging Waste Regulation: what changes for economic operators from 12 August 2026

1. In summary

Regulation (EU) 2025/40, known by the acronym PPWR, has applied in all Member States since 12 August 2026. It replaces Directive 94/62/EC, which was in force for thirty-two years, and takes the form of a regulation, which means direct application, without transposition and without waiting for national legislation.

Its scope is total. It covers all packaging placed on the Union market, regardless of material and origin, and the entire life cycle, from design to waste management. No sector is excluded and no material is exempt.

In general terms, the regulation introduces five families of obligations. Sustainability requirements, covering substances present in packaging, recyclability, minimum recycled content, compostability, minimisation of weight and volume, and reuse. Labelling, marking and consumer information requirements. Documentary compliance obligations, with technical documentation and an EU declaration of conformity, distributed along the whole chain, from supplier to distributor. Direct restrictions on the use of certain packaging formats and reuse targets. And, finally, a reinforced extended producer responsibility regime, with mandatory national registration in each Member State where packaging is placed on the market.

Most substantive requirements have their own dates, staggered between 2028 and 2038. But a significant part of the obligations is enforceable straight away, and it is largely documentary. Hence a feature worth remembering: non-compliance, under this regulation, is rarely visible on the packaging. It is visible in the file.

The text that follows runs through the regime with the detail the subject demands, identifies what is already enforceable today, what is deferred, and what the current exposure to penalties is in Portugal.

2. The architecture of the regulation and the first trap

The regulation is organised into thirteen chapters and seventy-one articles, with thirteen annexes concentrating much of the technical content. It entered into force on 11 February 2025 and applies from 12 August 2026, under Article 71, with deferred application of Article 67(5) until 12 February 2029.

A hasty reading leads to two symmetrical errors. One is to conclude that nothing changes yet, because the most visible targets are set for 2030. The other is to conclude that everything changes today, because the regulation is applicable. Neither conclusion is accurate, and the distinction between them has immediate financial consequences.

Before that, however, there is a trap that usually goes unnoticed and which conditions any analysis. Article 70 repeals Directive 94/62/EC with effect from 12 August 2026, but keeps four sets of provisions in force for different periods.

Article 8(2) of the directive remains applicable until thirty months from the entry into force of the implementing act to be adopted under Article 12(6) of the regulation, which does not yet exist. Article 9(1) and (2) remains in force as regards the essential requirements of Annex II, point 1, first indent, until 31 December 2029. Article 5(2) and (3), Article 6(1)(d) and (e), and Article 6a remain in force until 31 December 2028. And Article 12(3a) to (3c) and (4) remains in force until 31 December 2028, with its own regime as regards the reporting of data to the Commission.

3. Who is liable: subjective qualification decides everything else

In professional practice, this is the question most often settled by intuition and most often settled badly. The regulation builds a system of actors with distinct and cumulative obligations.

Manufacturer

Article 3(1), point 13, defines a manufacturer as the person who manufactures the packaging or the packaged product. Point (a) adds, however, that where a natural or legal person has packaging designed or manufactured under its own name or trade mark, that person is the manufacturer, irrespective of whether another trade mark appears on the packaging or on the packaged product.

The rule has broad reach. Any company that specifies and orders packaging bearing its own brand identity becomes a manufacturer for the purposes of the regulation, even if it owns no packaging production facility whatsoever. The manufacturer bears the obligations of Article 15, the conformity assessment of Article 38 and the EU declaration of conformity of Article 39.

Point (b) contains an exception of limited scope but radical effect: in the case of a microenterprise within the meaning of Recommendation 2003/361/EC, as applicable on 11 February 2025, and where the packaging supplier is located in the same Member State, the manufacturer is the supplier. Establishing the size of the company and the location of its suppliers is therefore the first step in any serious diagnosis.

Producer

Article 3(1), point 15, defines producer by reference to the first making available within the territory of a Member State. This is the relevant figure for the purposes of extended producer responsibility.

Point (c) contains the rule whose application I most often find unidentified. A person established in a Member State or in a third country who makes packaged products available for the first time within the territory of another Member State, directly to end users, is a producer in that other Member State. Two autonomous and cumulative obligations follow: registration in the national register of each of those Member States, under Article 44(2), and the appointment, by written mandate, of an authorised representative for extended producer responsibility in each of them, under Article 45(3).

The remaining actors

Chapter IV allocates specific obligations to importers, in Article 18, distributors, in Article 19, fulfilment service providers, in Article 20, and suppliers of packaging and packaging materials, in Article 16. Article 17 governs the authorised representative and Article 22 the identification of economic operators.

Article 21 deserves particular attention, as it determines the cases in which the manufacturer's obligations become applicable to importers and distributors. It is the classic mechanism of harmonisation legislation: whoever places packaging on the market under its own name or trade mark, or modifies packaging already placed on the market in such a way that compliance may be affected, assumes the position of manufacturer. In private-label distribution chains, this rule redistributes liability in ways that are not always reflected in the contracts in force.

4. What is already enforceable

Three blocks, and none of them depends on delegated or implementing acts still to be adopted.

Substances present in packaging

Article 5(1) imposes a general duty to minimise the presence and concentration of substances of concern, including as regards emissions and the outcomes of waste management and the adverse impact arising from microplastics.

Article 5(4) sets a determinate quantitative limit: the sum of the concentration levels of lead, cadmium, mercury and hexavalent chromium resulting from substances present in packaging or packaging components may not exceed 100 mg/kg.

Conformity assessment and EU declaration of conformity

Article 38 refers the conformity assessment against the requirements of Articles 5 to 12 to the procedure in Annex VII, which contains a single module, module A, designated internal production control.

This is self-assessment. There is no involvement of a notified body, no third-party certification and no conformity marking to be affixed to the packaging. The regime is therefore more demanding, not less, because it concentrates responsibility entirely on the operator.

Annex VII imposes four obligations. To draw up technical documentation making it possible to assess conformity and comprising an analysis and assessment of the risks of non-compliance, with a general description of the packaging and its intended use, design and manufacturing drawings, materials of the components, a list of the harmonised standards or common specifications applied, a qualitative description of the assessments provided for in Articles 6, 10 and 11 and test reports. To ensure that the manufacturing process and its monitoring guarantee conformity with that documentation. To draw up in writing a declaration of conformity for each packaging type. And, where applicable, to transfer the record-keeping obligations to an authorised representative.

The EU declaration of conformity follows the model in Annex VIII, which requires a unique identification number for the packaging and a description allowing it to be traced. Under Article 39(2), it must be kept permanently up to date and drawn up or translated into the languages required by each Member State where the packaging is placed or made available. The retention period is five years after placing on the market, rising to ten years for reusable packaging.

Upstream information

Article 16(1) obliges suppliers of packaging and packaging materials to provide the manufacturer with all information and documentation necessary to demonstrate conformity, including the Annex VII technical documentation required under Articles 5 to 11, in a language easily understood by the manufacturer and on paper or in electronic form. Paragraph 2 adds that, in the case of contact-sensitive packaging, the documentation required by the applicable Union acts forms part of that delivery.

This is not a supplier's option nor a matter for commercial negotiation. From a practical standpoint it is the most effective instrument available to operators right now, and it remains largely unused. A letter to the supplier, expressly invoking this rule and setting a deadline, is a zero-cost measure with immediate effect, both in obtaining the information and in building evidence of due diligence.

5. Sustainability requirements and the timetable that conditions investment

Structural packaging decisions are not taken in the year of the deadline. Procurement cycles, line changes, material qualification and graphic redesign all require several years of anticipation.

Recyclability

Article 6(1) provides that all packaging placed on the market must be recyclable. Paragraph 2 defines recyclability by two cumulative conditions: design for material recycling, so that the resulting secondary raw materials are of sufficient quality to substitute primary raw materials, and the possibility of separate collection, sorting without affecting other waste streams and recycling at scale.

Paragraph 3 expresses recyclability in performance grades A, B or C, in accordance with Annex II, Table 3. From 1 January 2030, or twenty-four months after the entry into force of the delegated acts under paragraph 4, whichever is the later, only packaging that is recyclable within the thresholds of grades A, B or C may be placed on the market. And from 1 January 2038, only grades A or B.

It is this second threshold, and not that of 2030, that should guide fundamental decisions on materials, combinations and components. The design-for-recycling criteria are set out in delegated acts that the Commission must adopt by 1 January 2028.

Minimum recycled content

Article 7 applies exclusively to the plastic parts of packaging. Contrary to what is frequently claimed, there is no recycled fibre target for paper or board.

From 1 January 2030, or three years after the implementing act under paragraph 8, whichever is the later, the following are required, calculated as an average per manufacturing plant and per year: 30 % for contact-sensitive packaging whose main component is PET, excluding beverage bottles; 10 % for contact-sensitive packaging made of other plastics, with the same exclusion; 30 % for single-use plastic beverage bottles; and 35 % for other plastic packaging. From 2040, those figures rise to 50 %, 25 %, 65 % and 65 %.

Paragraph 3 imposes sourcing requirements on the recycled material, and paragraph 4 provides for narrowly circumscribed exemptions, essentially in the field of medicinal products and medical devices.

Minimisation, compostability and reuse

Article 10(1) requires, by 1 January 2030, that packaging be designed so as to reduce weight and volume to the minimum necessary to ensure its functionality. Paragraph 2 prohibits the placing on the market of packaging that fails to meet the performance criteria of Annex IV and of packaging with features whose only purpose is to increase the perceived volume of the product, including double walls, false bottoms and unnecessary layers.

The Commission must request the European standardisation organisations, by 12 February 2027, to draw up harmonised standards setting maximum limits for weight and volume and, where appropriate, for wall thickness and empty space, for the most common types and formats.

Article 9(1) requires that, by 12 February 2028, permeable tea, coffee or other beverage bags and pods, and sticky labels affixed to fruit and vegetables, be compatible with the standard for composting in industrially controlled conditions. Rigid capsules are not covered by this obligation.

Article 11 sets the criteria for reusable packaging, complemented by Article 27 and Annex VI as regards reuse systems. An informal return circuit does not, without more, constitute a reuse system for the purposes of the regulation, which matters to anyone seeking to have their circuits count towards the targets.

6. Labelling, marking and environmental claims

Article 12(1) requires, from 12 August 2028 or twenty-four months after the implementing acts under paragraphs 6 and 7, whichever is the later, marking with a harmonised label based on pictograms concerning the constituent materials. Transport packaging and packaging covered by deposit and return systems are excluded, except in the case of e-commerce packaging.

The same paragraph allows operators, in addition to the harmonised label, to affix a QR code or another standardised, open digital data carrier with information on the destination of each separate component, in order to facilitate sorting. Packaging containing substances of concern, by contrast, must be marked using standardised, open and digital technologies.

Article 12(8) prohibits the display of labels, marks, symbols or inscriptions liable to mislead or confuse as regards the sustainability requirements, other packaging characteristics or the waste management options for which the regulation provides harmonised labelling. Paragraph 9 establishes that the identification of compliance with extended producer responsibility obligations is to be effected solely by means of a symbol affixed within a QR code or another standardised, open digital marking technology.

To this is added Article 14, on environmental claims, which dovetails with the unfair commercial practices regime. Sustainability communication that cannot be demonstrated has ceased to be a reputational risk and has become an autonomous legal risk.

7. Format restrictions and reuse targets

Article 24(1) requires that, by 1 January 2030 or three years after the entry into force of the implementing acts under paragraph 2, whichever is the later, operators filling grouped packaging, transport packaging or e-commerce packaging ensure a maximum empty space ratio of 50 %. The calculation methodology is a matter for an implementing act due by 12 February 2028. Until then, any calculation is conjectural.

Article 25(1) prohibits, from 1 January 2030, the placing on the market of packaging in the formats and uses listed in Annex V, which sets out six situations:

• single-use plastic grouped packaging designed as convenience packaging at the point of sale, with grouping and shrink films given as examples;
• single-use plastic packaging for less than 1.5 kg of fresh pre-packed fruit and vegetables, with the possibility of reasoned national exemptions, including on the grounds of the need to separate organic from conventional produce;
• single-use plastic packaging for food and beverages served and consumed in the hotel and catering sector;
• single-use plastic packaging for individual portions of condiments, sauces, cream, sugar and seasonings in the same sector, with exceptions;
• single-use packaging in the accommodation sector intended for individual guests;
• very lightweight plastic carrier bags, with exceptions on hygiene grounds and for loose foods.

Article 29 sets the reuse targets. Paragraph 1 requires, from 1 January 2030, that at least 40 % of transport and sales packaging used for transport, including pallets, boxes, trays, crates, drums, canisters, wrappings and straps, be reusable, with an indicative target of 70 % in 2040. Paragraph 2 requires full reuse for transport between sites of the same operator or between the operator and linked or partner enterprises. Paragraph 3 likewise requires full reuse where delivery is made to another economic operator in the same Member State. Paragraph 4 provides for relevant exemptions, notably for dangerous goods, for tailor-made packaging, for flexible formats in direct contact with food and feed and, expressly, for cardboard boxes.

8. Market surveillance: the mechanism already operating

Article 66 added Regulation (EU) 2025/40 to Annex I of Regulation (EU) 2019/1020 on market surveillance and compliance of products. The consequence is substantial and frequently overlooked: market surveillance powers apply to packaging, including requests for information, inspection, restriction, withdrawal, recall and prohibition of making available.

Chapter IX of the regulation develops the procedure applicable at national level to packaging presenting a risk, in Article 58, the Union safeguard procedure, in Article 59, the treatment of compliant packaging presenting a risk, in Article 60, controls on packaging entering the Union market, in Article 61, and formal non-compliance, in Article 62.

These are administrative supervisory measures. They do not depend on the existence of a national penalty regime, do not presuppose fault and take immediate effect on the goods. For many operators, the relevant risk is not the fine. It is a consignment immobilised at destination, in the middle of the season.

9. Penalties: the framework in force and what lies ahead

Article 68(1) requires Member States to lay down, by 12 February 2027, the rules on penalties applicable to infringements of the regulation, which must be effective, proportionate and dissuasive. Paragraph 2 expressly requires that penalties for infringement of Articles 24 to 29 include fines. Portugal has not yet adopted that regime, and the deadline has not yet expired.

It would be comfortable to conclude from this that breach of the regulation is currently immaterial under domestic law. It is not. And it is worth knowing the figures, because they are what correctly orders compliance priorities.

The environmental route

The core conduct, which consists in placing on the market packaging that does not meet the essential requirements, is prohibited by Article 88(3) of Decree-Law No 152-D/2017 and classified as a serious environmental administrative offence by Article 90(2) of the same instrument. The prohibitions in Article 88(1) and (2), concerning membership of a management system, entry in the register and markings, follow the same regime.

The applicable ranges are set out in Article 22(3) of Law No 50/2006. For natural persons, from EUR 2,000 to EUR 20,000 in cases of negligence and from EUR 4,000 to EUR 40,000 in cases of intent. For legal persons, from EUR 12,000 to EUR 72,000 in cases of negligence and from EUR 36,000 to EUR 216,000 in cases of intent.

In addition to fines there are the ancillary sanctions of Article 30, applicable to serious and very serious offences and lasting up to three years from the final decision. The list includes seizure and forfeiture of objects to the State, prohibition on exercising professions or activities whose exercise depends on a public title or authorisation, deprivation of the right to national or Community benefits or subsidies, deprivation of the right to take part in conferences, fairs or markets, deprivation of the right to take part in auctions or public tenders, closure of the establishment, termination or suspension of licences, permits or authorisations, loss of tax benefits, credit and financing lines, sealing of operating equipment, imposition of damage prevention and restoration measures, publication of the conviction and seizure of animals. Where there is obstruction of closure, sealing or restoration measures, interruption of the electricity supply may also be requested.

For companies whose activity depends on shipping calendars, industrial licensing, public support or presence at trade events, several of these ancillary sanctions have a greater economic impact than the fine itself.

The economic route

Failures relating to the producer register and the appointment of an authorised representative fall under Article 91 of Decree-Law No 152-D/2017, which refers to the Legal Regime of Economic Administrative Offences. Article 18(b) of that regime sets, for a serious offence, a fine of EUR 650 to EUR 1,500 for a natural person, EUR 1,700 to EUR 3,000 for a microenterprise, EUR 4,000 to EUR 8,000 for a small enterprise, EUR 8,000 to EUR 16,000 for a medium-sized enterprise and EUR 12,000 to EUR 24,000 for a large enterprise.

Classification is made, under Article 19, exclusively by the number of employees on 31 December of the calendar year preceding that in which the infringement came to light. Where size cannot be determined, the range for medium-sized enterprises applies. Article 22 doubles the minimum and maximum limits where the offender causes harm to the health or safety of persons or property, or derives from the infringement a calculable economic benefit exceeding the maximum limit of the fine. Ancillary sanctions are set out in Article 28, with a maximum duration of two years.

Food contact materials

The PFAS ban may also find indirect sanction cover. Article 3 of Decree-Law No 175/2007 classifies as a serious economic administrative offence the breach of the technical rules of Regulation (EC) No 1935/2004, including its Articles 3 and 4 and the specific measures adopted under Article 5, with its own ancillary sanctions in Article 4 and investigative competence vested in ASAE. The cover is not automatic, but is triggered whenever the presence of the substance also infringes that regulation or the positive list of Regulation (EU) No 10/2011.

The asymmetry, and what follows from it

10. Portugal: two gaps of a different nature

As things stand there is no national instrument implementing the regulation, and it is important to distinguish two situations that are not equivalent.

The first concerns the designation of the competent authority. Article 40(1) requires Member States to designate one or more authorities responsible for the application and enforcement of the obligations of Chapter VIII and also of Article 6(10), Article 29(1) to (7) and (9), and Articles 30 to 34. Paragraph 3 set 12 July 2025 as the deadline for notification to the Commission. Portugal does not appear on the published list. This is not a formality: it is to the competent authority that the producer register, the authorisation to fulfil extended responsibility and the prior notification of the placing on the market of innovative packaging are addressed.

The second concerns the penalty regime under Article 68, whose deadline expires only on 12 February 2027. Here there is no failure to comply.

Neither of these gaps affords protection. The environmental fines are in force. European market surveillance applies by virtue of the reference in Article 66. And enforcement takes place, to a large extent, in the market of destination, where several Member States have already designated their authorities. For operators with intra-Community activity, the national gap is irrelevant.

11. Six questions that measure exposure

Experience with harmonisation instruments suggests that a useful diagnosis does not begin with reading the regulation. It begins with six concrete questions, which the company must be able to answer without hesitation and in writing.

• First. Is the company a manufacturer within the meaning of Article 3(1), point 13(a), in respect of which packaging, and does it benefit from the exception in point (b)?
• Second. In which Member States is there direct making available to the end user and, in each of them, is there entry in the national register and an authorised representative appointed by written mandate?
• Third. How many packaging types exist in the portfolio, and for how many of them is there Annex VII technical documentation and a declaration of conformity issued by type, rather than by brand or by product?
• Fourth. Is there a supplier declaration, per food-contact component, on the PFAS thresholds of Article 5(5) and on the heavy metals limit of paragraph 4?
• Fifth. Which components accompany the packaging — seals, capsules, glues, inks, adhesives and decorative elements — and what is the foreseeable effect of each on the recyclability performance grade?
• Sixth. Which supply contracts in force contain no clause securing compliance with Article 16, and which distribution contracts fail to allocate the liability arising from Article 21?

A company that answers these six questions with confidence has the essentials settled for 2026 and a solid basis for 2030. A company that hesitates on two or more very probably has exposure that has not yet been identified, and whose quantification requires analysis of the specific case.

12. Closing note

For most operators, the PPWR is not an instrument of immediate rupture. It is an instrument of anticipation, with a markedly documentary initial period and a substantive core that matures between 2028 and 2038.

The management consequence is simple to state. Those who treat the period now beginning as a phase of documentary organisation will reach the following dates without disruption and with room to choose. Those who postpone will make the same changes in less time, with a smaller pool of compliant suppliers and no capacity to negotiate on price.