The EU Packaging and Packaging Waste Regulation (EU) 2025/40 (PPWR) has applied in full since 12 August 2026. All four categories of export packaging — food, pharmaceutical, medical device and tobacco — fall within its scope, but each is primarily governed by a different piece of legislation, and each has a different set of exemptions.
Between July and September 2026, new EU regulations significantly reshaped compliance for food contact materials (FCM). Key changes include a full ban on bisphenol A in single-use FCM, PPWR restrictions limiting PFAS in food packaging, updated purity rules for plastic FCM, and formal PET bottle recycled-content calculation guidelines including chemical recycling. Exporters must now back every shipment with updated Declarations of Conformity, mandatory BPA test reports (1 µg/kg detection limit), and documented PFAS screenings. Furthermore, recent RASFF data highlights bisphenol S, mineral oil, formaldehyde, and primary aromatic amine migrations as top compliance risks requiring routine testing.
Under the EU Packaging and Packaging Waste Regulation (PPWR), "Producer" is an Extended Producer Responsibility (EPR) role assigned to manufacturers, importers, or distributors who first place packaging on a Member State’s market. Producers face strict registration, fee, and reporting obligations. Non-EU sellers must appoint an Authorized Representative, while platforms like Amazon verify compliance.
PPWR imposes on all companies placing packaging on the EU market a full chain of obligations spanning substances, design, and recyclability. Medical device companies are no bystanders — although, given the special nature of their products, the primary packaging in direct contact with the product enjoys certain relaxations with regard to "recyclability" and "recycled content," core responsibilities such as minimization, hazardous substances, labeling, EPR, and the Declaration of Conformity apply in full. There is therefore no such thing as a complete exemption for medical device packaging under the PPWR framework.
The EU Packaging and Packaging Waste Regulation (PPWR, Regulation (EU) 2025/40), will become mandatorily applicable across the entire EU from August 12, 2026, replacing the 94/62/EC Directive that has been in force for nearly 30 years. PPWR is upgraded into a directly applicable regulation and it imposes full-chain requirements on all packaging placed on the EU marke
On 12 August 2026, the EU Packaging and Packaging Waste Regulation (PPWR, Regulation (EU) 2025/40) will become fully mandatory. This is not a "recommendatory" guidance document. It is a regulation with direct legal force, uniformly applicable to all EU Member States. From that date onwards, packaging that fails to meet requirements – including excessive heavy metals, non-compliant PFAS levels, incomplete EPR registration, or missing mandatory labels – may face product delisting, customs detention, heavy fines, or even exclusion from the EU market.
On June 5, 2026, the European Commission published the Guidance Document on the Packaging and Packaging Waste Regulation (PPWR).
Contact Us
