European Packaging Waste Legislation Repeals the Directive and Applies in Mid-2026

By Roxana Cernescu and Evangeline Loh

The European legislation on packaging waste (Regulation (EU) 2025/40) was adopted late last year (December 19, 2024) and published in the Official Journal of the European Union (OJEU) in January (January 22, 2025), repealing Directive 94/62/EC. Most provisions start to apply on August 12, 2026.

Directive 94/62/EC was concise. Regulation 2025/40 has 188 recitals, 71 definitions, 71 articles, and 13 annexes. The responsibilities of the manufacturer are identified in Article 15.

Manufacturers need to assess the regulatory requirements, and yes, this also applies to medical device and in vitro diagnostic (IVD) packaging and packaging waste. Additionally, aligned with our commentary, a previous directive was transformed into a regulation.

Is Regulation 2025/40 part of the New Legislative Framework (NLF)?

Regulation 2025/40 has elements of the NLF. Recital 108 states “coherence with other Union law” and “conformity assessment procedure should be an internal production control module” of Decision 768/2008/EC. Recital 109 discusses CE marking: no CE marking required as a measure of compliance with this legislation.

A declaration of conformity and technical documentation are expected.

There are conformity assessment bodies that can be engaged (Article 36(2)) and packaging in compliance with standards published in the OJEU presumes compliance with the requirements: Articles 5-12, 24, and 26 (Article 36(3)).

Regulatory technical documentation

Directive 94/62/EC doesn't explicitly delineate regulatory documents. Regulation 2025/40 requires a Declaration of Conformity (Article 39, Annex VIII). This can be drawn up as one single EU Declaration of Conformity for all applicable EU legislation or a “dossier made up of relevant EU declarations of conformity” (Article 39(3)).

It should not be difficult for a manufacturer of medical devices or IVDs to understand the technical documentation requirements described in Annex VII, Module A (2), as it meets expectations for technical documentation per Annex II of the Medical Devices Regulation (2017/745, MDR) and In Vitro Diagnostic Devices Regulation (2017/745, IVDR).

Requirements for packaging

Substances in packaging (Article 5) are a consideration. The European Commission (EC) with the European Chemicals Agency (ECHA) need to report on substances in packaging (December 31, 2026). The REACH Regulation (EC) 1907/2006 applies. Packaging needs to be recyclable (Article 6), note exclusions to contact-sensitive packaging for medical devices and IVDs (Article 6(11)(b) and (c)). Labeling of packaging is prescribed in Article 12.

For more information on the requirements of Regulation  2025/40, review the UL Solutions synopsis.

Concluding remarks

Regulation 2025/40 represents a significant revision from Directive 94/62/EC and a move towards the circular economy.

CE marking is not required, but evidence of compliance through the Declaration of Conformity is required.

This legislation reminds manufacturers of medical devices and IVDs that it is important to perform a comprehensive regulatory assessment to understand all the applicable legislation.