From 12 August 2026, Reg. (EU) 2025/40 — PPWR repeals Directive 94/62/EC and introduces direct documentation obligations for anyone placing PPWR packaging on the EU market: technical file, Declaration of Conformity and PFAS prohibition for food-contact packaging.
The PPWR concept of “manufacturer” overturns common intuition: it is not who physically produces the box, but who fills it and affixes their own brand.
The deadlines extend to 2040, but the first operational milestone with direct consequences for non-compliance is 12 August 2026!
The PPWR, Packaging and Packaging Waste Regulation, Reg. (EU) 2025/40, does not update Directive 94/62/EC: it replaces it entirely as of 12 August 2026. This means that conformity with the old directive does not guarantee conformity with the new Regulation, and that the technical files prepared under the old regime must be entirely redone.
The most significant change does not concern materials or substance limits, but the structure of documentation responsibility: for the first time, whoever packages and places products on the market is directly required to prepare a technical file and a declaration of conformity for the packaging itself, regardless of whether the packaging was purchased from a third-party supplier.
Who is the “manufacturer” of packaging under the PPWR?
Art. 3 of Reg. (EU) 2025/40 defines the manufacturer of packaging as the natural or legal person who places it on the market under their own name or trade mark. The definition is entirely independent of the physical production process of the packaging.
In practice, a company that purchases boxes, bags, bottles or any other type of container from a supplier and fills them with its own product, affixing its own brand, is, in all respects, the manufacturer of the packaging for PPWR purposes. Not the supplier who printed the box. Not the producer of the base material. The manufacturer is whoever transformed that packaging into a consumer product identified with their own name.
This definition directly affects the following categories of operators:
- Manufacturing SMEs that package their own products (food, cosmetics, detergents, household articles, toys) and market them under their own brand;
- Importers that affix their own brand to packaged products purchased from non-EU suppliers, thereby becoming manufacturers of both the product and the packaging for regulatory purposes;
- Retailers with own-brand products (private label) whose products are packaged by contract manufacturers: the production contract does not transfer the PPWR documentation responsibility to the contractor if the brand on the packaging belongs to the retailer;
- Distributors that repackage bulk goods for retail or horeca channel resale.
The PPWR packaging Regulation covers four categories, each with specific requirements: sales packaging (primary, in direct contact with the consumer), grouped packaging (secondary), transport packaging (tertiary) and service packaging (bags, trays, takeaway boxes provided at the point of sale). The basic documentation obligations, technical file and DoC, apply across all categories.
PPWR packaging obligations from 12 August 2026
Five main requirements must be met by 12 August 2026 for all packaging placed on the EU market.
1. Chemical substance restrictions in packaging
Reg. (EU) 2025/40 establishes mandatory limits for two categories of hazardous substances, with distinct scopes of application.
Heavy metals — all packaging: the total concentration of lead (Pb), cadmium (Cd), mercury (Hg) and hexavalent chromium (Cr VI) in packaging or its components must not exceed 100 mg/kg by weight. The limit applies to all types of packaging regardless of material, category and end use. Verification is documentary and must be included in section 4 of the technical file.
PFAS — food-contact packaging: prohibited to place on the market food-contact packaging exceeding the following thresholds:
- 25 µg/kg (ppb) for each individual PFAS (measured by targeted analysis, excluding polymeric PFAS);
- 250 µg/kg (ppb) for the sum of all PFAS (excluding polymeric PFAS);
- 50 mg/kg (ppm) for total PFAS, including polymeric PFAS.
In operational terms, the Regulation provides that verification begins with total fluorine analysis. If the result is below 50 mg/kg, the material is considered compliant and no further analysis is required. If the value is equal to or above 50 mg/kg, targeted analysis of individual PFAS must be carried out to verify compliance with the 25 and 250 µg/kg thresholds. Analytical results must be documented in section 4 of the technical file.
2. Packaging technical file
The technical file is the central document of the PPWR compliance system. It is autonomous with respect to the technical file for the product contained in the packaging, must be prepared before the packaging is placed on the market and kept for at least 10 years. The mandatory 8-section structure is described in the table below.
3. Declaration of Conformity (DoC) for packaging
The Declaration of Conformity for packaging, governed by Annex VIII of the PPWR, is a formal and legally binding document, separate from the product DoC. Whoever signs it assumes full responsibility for the conformity of the packaging with the requirements of the Regulation. It must be drawn up or translated into the language of the Member State where the packaging is placed on the market. The topic is examined in detail in the dedicated section later in this article.
4. Packaging identification
On the packaging, or on accompanying documents where technically impossible, the name, registered trade mark and physical contact details of the manufacturer must be indicated. A web address is not sufficient: the Regulation requires verifiable physical contact details. The batch or serial number is also required for traceability purposes.
5. EPR system alignment
Operators already registered with a national EPR scheme for packaging are already in the extended producer responsibility system. However, the PPWR packaging Regulation redefines the requirements that national EPR schemes must meet, including updated calculation methods, collection and recycling targets by material category and eco-modulation obligations for contributions based on packaging recyclability. Registration with the national EPR scheme is a necessary but not sufficient condition: it is necessary to verify that the declared packaging categories, the quantities placed on the market and the contribution system are aligned with the new PPWR requirements.
The PPWR technical file: 8-section structure
The technical file is not a standardised form: it is a structured dossier that demonstrates, in a verifiable manner, the conformity of the packaging with the requirements of the Regulation. The 8 mandatory sections are as follows:
| # | Section | Required content |
|---|---|---|
| 1 | Identity of the economic operator | Name, registered trade mark and physical contact details of the manufacturer. If the manufacturer is established outside the EU, also indicate the authorised representative in the Union with reference to the written mandate. |
| 2 | Description of the packaging | Type of packaging (category: primary, secondary, tertiary, service), function, dimensions, weight, main materials. Photographs or technical drawings of the various components. |
| 3 | Material composition | List of all materials and components with percentages by weight, origin (virgin or recycled) and relevant technical specifications. |
| 4 | Conformity with substance restrictions | Documentation demonstrating compliance with limits for hazardous substances (including PFAS for food-contact packaging according to the 3-step approach). Supplier declarations, safety data sheets, laboratory tests where applicable. |
| 5 | Tests and test results | Laboratory reports, technical calculations or other evidence supporting conformity with the essential requirements of the Regulation. |
| 6 | Presumption of conformity | Reference to the harmonised EN standards applied, where available and recognised under the PPWR. In the absence of updated harmonised standards, alternative conformity documentation. |
| 7 | Recyclability and reusability | Documentation demonstrating compliance with recyclability targets or, for reusable packaging, with the reusability requirements applicable to the specific category and time frame. |
| 8 | Declaration of Conformity (DoC) | Copy of the DoC drawn up pursuant to Annex VIII of the PPWR, signed by the responsible party. Must be in the language of the Member State where the packaging is placed on the market. |
Note on harmonised standards EN 13428/13430: these standards were the basis for the presumption of conformity with Directive 94/62/EC. With the PPWR, they lose their automatic presumption of conformity status until they are updated and cited in the Official Journal of the EU as harmonised standards under the new Regulation. In the meantime, conformity must be demonstrated through the technical documentation in section 5 of the file.
The packaging Declaration of Conformity: who is the responsible party?
The packaging DoC is an autonomous document with respect to the product DoC. A company placing a CE-marked packaged product on the market — for example a household appliance or a toy — must prepare both the product DoC (under the applicable sector directives) and the packaging DoC under Annex VIII of the PPWR. The two documents coexist and cover distinct regulatory obligations.
The Regulation identifies the parties who may sign the packaging DoC:
- The packaging manufacturer (whoever places it on the market under their own name or brand), who is the primarily responsible party;
- The manufacturer’s authorised representative in the EU, where the manufacturer is established outside the European Union and has issued a specific written mandate that includes signing the DoC among the delegated responsibilities.
EPR registration: PPWR conformity is not automatic
National EPR schemes for packaging have been operational in EU Member States for decades and cover the vast majority of operators placing packaging on the national market. Registration with the national scheme and payment of the environmental contribution continue to be the basic requirement for packaging EPR.
The PPWR packaging Regulation does not replace national EPR schemes, but redefines the requirements they must meet by the date of application of the Regulation. The main changes concern: EU-level harmonised reporting, updated criteria for calculating recycling targets by material category, eco-modulation of contributions based on packaging recyclability and traceability of volumes placed on the market.
It is therefore necessary to verify that one’s EPR registration correctly reflects all packaging categories actually placed on the market, the actual quantities for the last 12 months and any need to update periodic declarations. Operators handling food-contact packaging must also separately verify conformity with the PFAS prohibition, a requirement that national EPR schemes do not certify.
PPWR deadlines from 2026 to 2040
The provisions of the PPWR packaging Regulation enter into force progressively over 15 years. The full timeline is essential for planning product and process adjustments in advance:
| Date | Obligation | Entities involved |
|---|---|---|
| 12 August 2026 | General application. Substance obligations (heavy metals, PFAS, BPA, CMR). Conformity assessment (Module A). Technical file and declaration of conformity. Manufacturer identification on packaging. EPR registration. | Manufacturers, importers |
| 12 August 2028 | Harmonised labelling for separate collection: pictograms and material codes defined by the Commission, mandatory on each packaging unit. | Manufacturers, importers |
| 12 February 2029 | Mandatory QR code on each packaging unit, providing access to: material composition, recyclability class, separate collection instructions, reusability indication. | Manufacturers, importers |
| 1 January 2030 | Recyclability: all packaging classified in classes A, B or C according to DfR (Design for Recycling) criteria defined by the Commission. | Manufacturers, importers |
| 1 January 2030 | Recycled content: first mandatory thresholds for plastic packaging (PET bottles: 30%; other plastic packaging: 10-35%, depending on category). | Manufacturers of plastic packaging |
| 1 January 2030 | Minimisation: prohibition of double walls, false bottoms and excessive empty space (50% limit for grouped and transport packaging). | Manufacturers, importers |
| 1 January 2030 | Prohibition on placing 6 categories of single-use packaging on the market (see section 8.2). | Manufacturers, importers |
| 1 January 2038 | Recyclability: only classes A (high recyclability) and B (medium recyclability) permitted. Class C is eliminated. | Manufacturers, importers |
| 1 January 2040 | Recycled content: second mandatory thresholds for plastic packaging (PET bottles: 65%; other plastic packaging: 50-65%, depending on category). | Manufacturers of plastic packaging |
Market surveillance and risk profile for operators
Reg. (EU) 2025/40 is directly applicable in all Member States without national transposition. Member State market surveillance authorities are competent for controls. The national penalty regime will be defined by a specific implementing act before the date of application and must provide for “effective, proportionate and dissuasive” sanctions, with the possibility of confiscating non-compliant packaging and prohibiting its placement on the market.
On the operational side, documentary non-conformity with the PPWR packaging Regulation exposes operators to risks that go beyond monetary penalties: customs holds for packaging imported from third countries and sales interruption in the event of a market withdrawal ordered by the authority. Operators with the greatest risk exposure are importers of packaged products from non-EU countries, SMEs in the food-contact sector with packaging potentially affected by the PFAS prohibition, and brand owners who have packaging produced by contractors.
Frequently Asked Questions (FAQ)
Who is considered the “manufacturer” of packaging under the PPWR?
Under Art. 3 of Reg. (EU) 2025/40, the manufacturer of packaging is the natural or legal person who places it on the market under their own name or trade mark. In practice, whoever fills or packages the product is the manufacturer of the packaging for PPWR purposes, regardless of who physically produced the box or bag.
What must the PPWR packaging technical file contain?
The PPWR technical file is structured in 8 sections: identity of the responsible operator, technical description of the packaging, material composition with percentages by weight, documentation on conformity with substance restrictions (including the 3-step PFAS approach for food-contact packaging), test results, applied harmonised EN standards, documentation on recyclability or reusability, and a copy of the DoC. The technical documentation and the declaration of conformity must be kept for 5 years from the date the packaging is placed on the market for single-use packaging, and for 10 years for reusable packaging.
Does the PPWR packaging DoC replace the product Declaration of Conformity?
No. The Declaration of Conformity for packaging under Annex VIII of the PPWR is an autonomous document, separate from the product DoC. A company placing a CE-marked packaged product on the market must prepare both the product DoC (under the applicable sector directives) and the packaging DoC under the PPWR. The two documents cover distinct regulatory obligations.
Is packaging compliant with the old Directive 94/62/EC automatically compliant with the PPWR?
No. Reg. (EU) 2025/40 repeals Directive 94/62/EC as of 12 August 2026. Conformity with the old directive does not guarantee conformity with the new regulation, which introduces additional requirements not previously in place: PFAS prohibition for food-contact packaging, structured technical file, mandatory DoC and progressive recyclability targets. A specific assessment against the PPWR is required.
How does the 3-step approach work for verifying PFAS compliance in food-contact packaging?
The official DG ENV 2026 FAQs on the PPWR describe a graduated approach: Step 1, documentary verification via supplier declarations on the absence of intentional PFAS addition; Step 2, qualitative screening analysis on the finished product to detect total fluorine; Step 3, quantitative confirmatory analysis on individual suspected PFAS substances. It is not necessary to carry out all three steps if the previous one gives a negative result, but each step performed must be documented in the technical file.
Does the PPWR also apply to service packaging provided at the point of sale?
Yes. Reg. (EU) 2025/40 covers four categories of packaging: sales packaging (primary), grouped packaging (secondary), transport packaging (tertiary) and service packaging, i.e. bags, trays, takeaway boxes and similar items provided at the point of sale. The technical file and DoC are mandatory for all categories from 12 August 2026; reusability requirements apply in a differentiated manner by category.
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