The European Commission has confirmed the special status of pharmaceutical packaging under the European Packaging and Packaging Waste Regulation (PPWR). Accordingly, primary pharmaceutical packaging is exempt from the requirements regarding recyclability and recycled content. However, by 2035 the Commission intends to review whether the exemptions concerning recyclability remain justified.
The Commission justifies the exemptions on the grounds of the special regulatory requirements for medicinal products. The packaging of a medicinal product is an integral part of its marketing authorisation, with patient safety at the core. Therefore, such packaging is exempt from the recyclability and recycled content requirements of Regulation (EU) 2025/40.
Exceptions will be reviewed in 2035
However, at least part of this special status is not permanently fixed. The Commission has announced that by 2035 it will review whether the exemptions from the recyclability requirements – including those for medicinal products – should be revised.
The statement was done in response to a parliamentary question. This dealt, among other things, with the issue of how more sustainable pharmaceutical packaging can be promoted and regulatory hurdles regarding changes to already approved medicinal product packaging can be addressed.
According to the Commission, existing EU pharmaceutical law already provides mechanisms that allow the European Medicines Agency to evaluate post-authorisation changes according to their nature and potential impact on the medicinal product. The Commission is monitoring developments and potential approaches that enable sustainability objectives and regulatory requirements to be reconciled.
EU funds more sustainable packaging solutions
Furthermore, the Commission points to research projects under Horizon Europe. Among other things, the SolRec2 project has developed prototypes and recycling strategies for e-paper labels, pharmaceutical blister packs, and waste from laminate packaging. Other projects deal with the circular economy, alternatives to single-use solutions, and bio-based materials. The development of new packaging materials is also to be supported in future within the framework of European research programmes.
Source: EU Commission
