PPWR now applies: what packaging manufacturers need in place
Regulatory briefing · 16 October 2026
Packaging
The EU Packaging Regulation now applies. Medical device packaging is not exempt. Northern Ireland is in.
Jonathan Phillips, Lead Auditor. 16 October 2026.
The Packaging and Packaging Waste Regulation (PPWR) is the EU law that sets rules for all packaging placed on the EU market.
It is Regulation (EU) 2025/40. It has applied since 12 August 2026. It applies directly in every Member State. There is no national transposition and no general postponement.
I am currently running a number of PPWR implementation projects for clients. This briefing sets out what applies now, what comes later, and the points most often missed.
In short: most PPWR duties apply now. Medical device packaging gets narrow exemptions only. Northern Ireland is in. Great Britain is out but has its own rules.
At a glance
PPWR replaced the Packaging Directive 94/62/EC on 12 August 2026.
It covers all packaging placed on the EU market, including packaging imported with a product.
Heavy metal limits, substances of concern and conformity documentation apply now.
The manufacturer signs an EU declaration of conformity for the packaging.
Packaging must carry identification and manufacturer details.
Sorting labels, recyclability grades and recycled content targets come later.
Medical device and IVD packaging gets narrow exemptions only.
Most PPWR product rules apply in Northern Ireland. EPR does not.
PPWR does not apply in Great Britain. UK packaging rules apply instead.
The PPWR authorised representative is not the MDR authorised representative.
What applies now Articles 5 and 15
From 12 August 2026, packaging placed on the EU market must meet these requirements:
Heavy metals: lead, cadmium, mercury and hexavalent chromium must not exceed 100 mg/kg combined in packaging or any packaging component.
Substances: substances of concern in packaging materials must be minimised.
PFAS: PFAS limits apply to food-contact packaging.
Conformity: the manufacturer carries out the conformity assessment (internal production control), draws up technical documentation and signs an EU declaration of conformity.
Identification: packaging must carry a type, batch or serial number and the manufacturer’s name and postal address. Where that is not possible, the information can go in a digital data carrier or an accompanying document. Importers add their own details.
Suppliers: suppliers of packaging and packaging materials must give the manufacturer the information needed to show conformity.
CE marking on packaging does not show PPWR compliance. Where a CE mark appears on packaging, it relates to the product inside. PPWR compliance is shown by the declaration of conformity.
Existing stock
Packaging already placed on the market before 12 August 2026 can stay in the supply chain. Packaging placed on the market after that date must comply, even if it was made earlier.
The Commission FAQ (second edition, August 2026) gives limited relief for existing stock. It does not need to be destroyed or relabelled. The identification details can be supplied in an accompanying document. The substance limits still apply.
What comes later
Several dates depend on Commission implementing or delegated acts. Some of those acts are late. Where an obligation is tied to an act, the date moves with it. The dates below are the earliest possible dates.
Labelling: harmonised sorting labels from 12 August 2028, or 24 months after the implementing act, whichever is later. The act is not yet adopted. The Commission plans it for late 2026, so the label date is likely to move.
Recyclability: packaging must meet recyclability performance grades A to C from 2030. Only grades A and B from 2038.
Recycled content: minimum recycled content targets for plastic packaging from 2030, or three years after the calculation act, whichever is later.
Empty space: a maximum 50% empty-space ratio for grouped, transport and e-commerce packaging from 2030.
Reuse: reuse targets for certain transport and sales packaging from 2030.
The 2030 requirements need design changes. Design changes take time, particularly where packaging is validated. Work on them should start now.
Medical devices and IVDs Articles 6, 7 and 12
Medical device and IVD packaging is not excluded from PPWR. The exemptions are narrow.
Contact-sensitive packaging of medical devices under Regulation (EU) 2017/745 and IVDs under Regulation (EU) 2017/746 is exempt from two requirements:
the recyclability requirements
the minimum recycled content targets for plastic packaging
Everything else applies. That includes heavy metals, substances of concern, identification details, technical documentation and the declaration of conformity.
A sterile barrier pouch is contact-sensitive packaging and is exempt from recyclability grading. The shipper carton around a box of devices should be assessed on its own, not assumed to be exempt.
There is also labelling relief where there is no space on the device packaging because of MDR or IVDR labelling requirements. The position should be documented for each packaging format.
The MDR or IVDR technical documentation does not cover the packaging under PPWR. PPWR has its own documentation requirements.
Northern Ireland Windsor Framework
Under the Windsor Framework, most PPWR product requirements apply to packaging placed on the Northern Ireland market. That includes the substance limits, conformity requirements and labelling.
Some provisions do not apply in Northern Ireland. These include extended producer responsibility, deposit return schemes, reuse and refill targets and Member State targets. Northern Ireland stays within the UK packaging EPR scheme.
Great Britain
PPWR does not apply to packaging placed on the market in England, Scotland or Wales. Packaging in Great Britain follows UK rules:
Product rules: the Packaging (Essential Requirements) Regulations 2015 set minimisation, recoverability and heavy metal limits. These pre-date PPWR and are based on the old EU directive.
UK EPR: producers register and report packaging data. Larger producers pay disposal fees. From the 2026–27 year, fees vary with a recyclability rating.
Plastic tax: Plastic Packaging Tax applies to plastic packaging with less than 30% recycled plastic.
Deposit return: a deposit return scheme for drinks containers is expected from 1 October 2027.
UK packaging EPR and Plastic Packaging Tax also apply in Northern Ireland. A business supplying Northern Ireland can therefore face PPWR product requirements and the UK schemes at the same time. A business supplying Great Britain, Northern Ireland and the EU needs a clear position for each market.
The PPWR authorised representative Article 45(3)
A producer established in another Member State or outside the EU, supplying packaging or packaged products directly to end users, must appoint an authorised representative for extended producer responsibility in that Member State.
This is not the same role as the authorised representative under Article 11 of the MDR or IVDR. The two appointments are separate and can be held by different companies.
In December 2025 the Commission proposed suspending this obligation until 2035. On 5 October 2026 the European Parliament’s environment committee voted to limit any suspension to EU-based micro and small enterprises. A plenary vote is anticipated. The Council has not agreed a position. Until an amending act is published in the Official Journal, the obligation applies.
What to do now
List every packaging specification, layer by layer: primary, sales, grouped and transport.
Identify the PPWR manufacturer and producer for each specification and each market. These are not always the same company as the device manufacturer.
Request supplier information by specification: materials, weights, heavy metal results and substances of concern.
Build the technical documentation and declaration of conformity.
Record any exemption claimed, and the reasoning for it.
Check Northern Ireland, Great Britain and EPR obligations separately for each market.
Plan the 2030 design changes now, including any re-validation.
If you would like help, please contact us. We can:
run a PPWR gap check against your current packaging
build your packaging inventory and supplier information requests
prepare technical documentation and declarations of conformity
assess exemptions for medical device and IVD packaging
set out your Northern Ireland and Great Britain market positions
This briefing is for general information and is not legal advice. Several implementing and delegated acts are still to be adopted and may change what is required. ■
Sources
Regulation (EU) 2025/40 on packaging and packaging waste, OJ L, 22 January 2025. European Commission, PPWR Frequently Asked Questions, second edition, August 2026. Commission Notice C/2025/946 on the application of Regulation (EU) 2025/40 in respect of Northern Ireland. DAERA, Packaging and Packaging Waste. House of Commons Library briefing CBP-10352, 29 July 2026. Commission proposal COM(2025) 982 and European Parliament procedure file 2025/0395(COD).
Jonathan Phillips is Managing Director of B.S. Partnership Ltd, Cardiff, and EU-UK Authorised Representative Ltd, Belfast. This page reflects the legislative position as at 16 October 2026.