At the end of 2022, the European Commission published the draft of the revision of the packaging legislation aimed at reducing the environmental impact, raising perplexities from associations in the pharmaceutical sector.
New legislation on the horizon
On November 30th 2022 European Commission published the draft of a new regulation about recycling and reusing of packaging. The goal is to reduce the differences in labelling and recycling rates of packaging materials and their reuse between European countries, as well as increasing these percentage. Differences between member States can only lead to legal uncertainties, decreasing investments on environmental sustainability and on new business models linked to the circular economy. A trend that fits badly with the objectives of the UN 2030 Agenda and more generally with the environmental awareness being spread.
European Commission says environmental problems related to packaging are far from negligible. In fact, the packaging use, or we should say abuse, has increased by 20% in the last 10 years leading to an increase in the amount of waste generated by it, only partially offset by the recycling rate, growing at a slower rate. Compared to 2018, for example, plastic packaging waste is expected to increase by 46% by 2030 and 61% by 2040. There are also many environmental weaknesses related to packaging that have not been adequately addressed by the current legislation, dated 1994, such as redundant packaging, non-recyclable materials mixed with those that are, labels that do not help the consumer to practice proper separate collection and a very low percentage of recycled materials in plastic packaging. The draft of the future legislation therefore aims to work on these still unresolved issues that cause the failure to recycle technically recyclable materials or obtain recycled materials of too low quality to be reused effectively due to the practical difficulties or economic disadvantage of the operation.
The skepticism of pharmaceutical associations
The draft in the new legislation already provides for derogations for the pharmaceutical sector, aimed at ensuring high levels of protection of human and animal health and avoiding problems of availability and safety of medicines and medical devices. An example is the minimum content of recycled material in plastic packaging, widely used in the pharmaceutical sector. According to the draft, in fact, by January 1, 2030, plastic packaging must contain a minimum of 10% to a maximum of 35% of recycled material, depending on the type of plastic concerned; the percentage rises to 50-65% by January 1, 2040. But these deadlines do not apply to the pharmaceutical sector, for which the regulation would not come into force until 2035, so as to give companies time to adapt while remaining compliant with the other numerous rules to which they are subject. Furthermore, patient safety is also in first place for the European Commission: particular exemptions are in fact provided for packaging in contact with the product and in general in those cases in which it may preclude the safety of the drug or medical device.
Nevertheless, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has coldly welcomed the European Commission’s draft. The specificities of pharmaceutical production, the stringent regulations to which the sector is subject and the production continuity essential to guarantee drugs on the market, go badly with the new possible rules.
Pros and cons
The benefits of the draft regulation are concrete. Increasing the efficiency of recycling and reuse and stimulating models based on the circular economy is a way to decouple economic growth from the use of virgin raw materials with positive repercussions on biodiversity and in general on our health and that of our planet. The use of new raw materials, moreover, often implies a purchase linked to imports that make companies dependent on other countries and on fossil fuels necessary for their production and transport. And today more than ever the advantages of greater energy and economic independence are obvious, not only from an environmental point of view.
Of course, it remains to evaluate the negative impact of such a regulation, which poses very challenging logistical and temporal constraints, for the drug supply chain as well as for the other sectors involved. While the document continues the approval process, the discussion between industry associations and the European Commission is open. The new legislation would address many unresolved issues related to recycling and reuse of packaging materials: will the derogations provided for the pharmaceutical sector be sufficient?
The legislation in pills
The draft regulation on packaging and related waste, issued by the European Commission last November 30th, applies to all types of packaging and to all EU Member States. The legislation addresses many points left unresolved so far.
- Reduction of packaging waste compared to 2018 data: -5% by 2030, -10% by 2035 and -15% by 2040
- Reduction of packaging: minimum empty space ratios set for certain product categories and for transport packaging
- Prohibited packaging with strategies that create the impression of an increase in the volume of the product, such as the double bottom
- Restrictions for different categories of packaging, such as single-use packaging for fruits and vegetables
- From 1 January 2028 obligation to ensure that the deposit system meets certain minimum criteria and to establish deposit systems for single-use plastic and metal containers for beverages with a capacity of up to 3 litres
- Obligation for economic operators, including producers and final distributors, to comply with minimum re-use rates: for cold and hot drinks filled in takeaway outlets, 30% by 2030 and 95% by 2040; for ready-to-take away food 20% by 2030 and 75% by 2040. For alcoholic beverages, excluding wine and spirits, 20% by 2030 and 75% by 2040; for soft drinks, 20% by 2030 and 75% by 2040; for transport and grouped packaging, 20% by 2030 and 80% by 2040
- Exemption for wine and certain alcoholic beverages, milk and milk products
- Exemption for member States with a packaging collection rate of more than 90% in the two years prior to the entry into force of the legislation
- A minimum amount of recycled material is envisaged: in contact-sensitive plastic packaging 25% by 2030 and 50% by 2040, in single-use plastic beverage bottles 50% by 2030 and 65% by 2040, in other plastic packaging 45% by 2030 and 65% by 2040
- Possible temporary changes to these minimum contents if availability or excessive pricing issues justify it
- Negative list of packaging characteristics
- Pharmaceutical primary packaging exempted from the obligation until 1 January 2035
- Compostable packaging:
- Mandatory for certain uses, such as tea bags, coffee pods and lightweight plastic bags
- Mandatory instructions for sorting addressed to consumers harmonised at Community level, to be affixed also to bins
- Mandatory reuse label on the packaging and QR code that provides additional information on the reusability of the packaging, the collection system and the points where it takes place
- For voluntary labelling of recycled content, compliance with the calculation methodology and verification of the minimum content of recycled material
- Shoefield I., “Pharma industry “cautious” over EU packaging & recycling proposal. Pharma Intelligence”, december 2022
- Confindustria, “Proposta di regolamento del Parlamento europeo e del Consiglio sugli Imballaggi e sui rifiuti di imballaggio che modifica il regolamento (UE) 2019/1020 e abroga la direttiva 94/62/CE”, october 2022