EU Parliament Stricter Than Council on Medicines and Medical Devices Packaging
The EU Parliament's Environment, Public Health and Food Safety committee takes a compromise position with regards to the Packaging and Packaging Waste Directive (PPWD). Medicines and medical devices should be exempt, but only until 2035, at which point the European Commission should check whether the development of materials and the recycling process have progressed, and may adjust this exemption accordingly.
The European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) wants medicines and medical devices to be exempt from new packaging rules proposed within the Packaging and Packaging Waste Directive.
However, only until 2035, at which point the European Commission should check whether the development of materials and the recycling process have progressed, and may adjust this exemption accordingly.
Having lobbied for exemption, the German Medicines Manufacturers' Association, BAH, described the Parliament’s position as “important,” as suitable alternatives to plastic medicine blister packs “are not available.”
“The packaging of medicinal products and medical devices must fulfill extensive safety requirements,” the association commented. “Therefore, it is important that these product groups are exempted from the recycling obligation at least until 2035, as suitable materials are currently not available.”
In its response to the commission’s PPWD consultation process, Haleon also pointed out that there is currently “no technically recyclable solution commercially available at scale that ensures the quality, safety and efficacy” of medicinal products. (Also see "Haleon Supports EU Packaging Proposals but Has ‘Serious Concerns’ About Timings" – HBW Insight, April 18, 2023.)
Today, medicines are packaged in not-recyclable materials such as polyethylene (PE) with an aluminum barrier layer or PVC/PVdC, the company explained. Alternative recyclable materials with an equivalent barrier are still 10 to 15 years away for consumer healthcare products, it added.
Technological progress may mean the exemption will be lifted in 2035, most likely with an additional transitional period, BAH noted. “We are already supporting our members on this path,” it said.
MIDDLE GROUND
With its 2035 review, ENVI is taking a position somewhere between the commission and the EU Council within the PPWD trilogue negotiations process, which was expected to wrap up so that the directive could be published in the EU Official Journal in September 2024.The commission’s original proposal states that all packaging should be recyclable by 2030, with special provisions for medicines packaging, which would need to also be recyclable by 2035.
The EU Council then amended these proposals to “exclude from the obligation of a minimum recycled content in plastic packaging” the “outer packaging of human and veterinary medicinal products … in cases where it has to comply with specific requirements to preserve the quality of the medicinal product.”
Touch-sensitive plastic packaging for medical devices and in-vitro diagnostic devices should also be exempt, according to the council. (Also see "Medicines and Medical Devices Should Be Exempt from New Plastic Packaging Rules Says EU Council" – HBW Insight, Jan. 10, 2024.)
ENVI’s proposal, which offers some hope to medicines and medical devices manufacturers that the exemption might continue after 2035 if no viable alternatives are found, will need to be formally accepted by the EU Parliament and go back to the EU Council for approval.
However, BAH said that “due to the political agreement, adoption is very likely.”
SUPPLEMENTS: NO EXEMPTION
Food supplements will still feel the full force of the PPWD when it comes into effect, except for contact-sensitive packaging for baby food and other foods for special medical purposes, which under ENVI’s interpretation would benefit from the same exemption as medicines and medical devices.
“Manufacturers of food supplements must ensure that their packaging meets the recyclability requirements from 1 January 2030,” BAH explained. “Packaging materials that are not at least 70% recyclable may no longer be placed on the European market.
“By 1 January 2038, the minimum requirement will rise to 80%,” the association continued. “Therefore, the recyclability determines the sales authorization of products such as food supplements.”
