illev Pharma East has a highly educated and dedicated team of international experts with many years of experience in Pharmaceutical industry.

26 January 2023

European Green Deal – draft regulation on packaging and packaging waste and impact on medicines



In November 2022 the EU Commission published its proposal for a new Regulation on EU packaging and packaging waste framework (Regulation of the European Parliament and of the Council on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC). The Regulation which will have major implications for the entirety of the packaging and waste management chain:

  • new minimum mandatory recycling targets across all packaging;
  • new member state recycling targets;
  • new mandatory reuse and refill targets;
  • new reporting and labelling obligations;
  • seeming recognition of chemical recycling as counting towards targets.

The EU is seeking to introduce wide-ranging new requirements for the recycling and re-use of packaging materials to lessen the impact of packaging on natural resources and reduce Europe’s dependence on raw materials and fossil fuels. The draft legislation sets out minimum recycled content targets, minimum reuse and refill targets, mandates packaging recyclability, requires the implementation of deposit return schemes, sets out requirements for biodegradable packaging, reporting and labelling requirements, and appears to allow the use of chemical recycling in recycling targets as long as its end output is not used for fuel or backfilling applications. The Regulation repeals the existing Packaging and Packaging Waste Directive 1994 (European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste), and, if passed in its current form, would provide affected businesses and EU Member States with more certainty on EU-wide packaging rules by addressing perceived gaps in the existing framework. The new Regulation would apply to all packaging sold and used in the EU as well as all packaging waste generated within the EU.


Changes proposed to the existing framework

The draft Regulation proposes some significant changes to the current EU packaging and packaging waste framework:

  • Recyclable packaging: the Regulation would stipulate a high threshold for what is considered to be ‘recyclable packaging’, requiring packaging to be designed for recycling at scale and to be sorted easily (amongst other requirements). The Regulation would also allow the Commission, through delegated acts, to introduce a new grading system to assess recyclability design, ranking packaging from A to E in line with specific design for recycling criteria and performance grades; Grade A being the highest (design for recycling criteria of a unit of packaging is higher or equal to 95% in terms of weight of the unit of packaging.) The lower the grade, the higher the fees producers will have to pay through Extended Producer Responsibility obligations.
  • ‘Empty space’ packaging: Although the broad definition of ‘packaging’ remains materially the same as in the Directive, the Regulation would capture new assemblies of packaging. For example, it seeks to reduce packaging with excessive ‘empty space’, including space filled by materials such as bubble wrap, air cushions, foam fillers or polystyrene to reduce the amount of packaging used. The Regulation would require that packaging be designed so that its weight and volume is reduced to the minimum necessary. Economic operators, who supply products to a final distributor or end user, will be required to ensure that each unit is scaled down to its minimum size and meets the new ‘empty space ratio’ limit of 40%, defined as the difference between the volume of packaging and the volume of the product within the packaging (i.e. no more than 40% of the total volume of packaging can be empty space). Whilst all packaging producers will need to re-assess their packaging methodology, if the Regulation is passed, ecommerce businesses are specifically highlighted in the draft Regulation as a focus area.
  • Restrictions and bans on certain packaging formats: The draft Regulation contains new prohibitions on:
    • the use of ‘superfluous’ packaging which does not fulfil a packaging function (e.g. cardboard boxes containing toothpaste containers);
    • packaging formats which are misleading to consumers such as packaging which creates the impression of increased product volume. While the draft Regulation accepts that marketing remains a packaging function, marketing does not in and of itself justify additional packaging weight and volume; and
    • Specific packaging formats including single use packaging for condiments, packaging in expanded polystyrene (such as food containers), single-use mini-bar bottles, and single-use miniature soaps, shampoo bottles and body lotions (which are often used in hotels). Note that the Single-Use Plastics Directive already bans certain types of plastic packaging.
  • QR codes to track reusability. The draft Regulation proposes mandatory QR codes (or other type of digital carrier) to provide consumers with more information on the product’s packaging reusability and to show collection points for recycling. The Regulation also envisages a time where the use of QR codes could facilitate the tracking and calculation of rotations of the plastic through the recycling system. This would place more information in the hands of consumers and require manufacturers to ensure that they are closely involved in the journey of packaging through-out its life-cycle.

Impact on pharmaceutical industry

While the pharmaceutical industry will be as affected as any other by the new rules, it would enjoy some limited exemptions under the current proposals. As of 1st of January 2030, the draft regulation says that plastic parts in packaging must contain a minimum percentage of recycled content recovered from post-consumer plastic waste (10-35% depending on the type of plastic). The percentages will rise to 50-65% from 1st of January 2040.


However, the minimum recycled plastic content requirements will not apply to immediate packaging as defined in Article 1 of Directive 2001/83/EC of the European Parliament and of the Council and in Article 4(25) of Regulation (EU) 2019/6 of the European Parliament and of the Council, which are in direct contact with the medicinal product, as well as contact sensitive plastic packaging of medical devices covered by Regulation (EU) 2017/745 of the European Parliament and of the Council and of in vitro diagnostics medical devices covered by Regulation (EU) 2017/746 of the European Parliament and of the Council. These exemptions should apply until 1st of January 2035. The draft Regulation states that the derogations, which will be in place until 2035, are necessary to ensure »a high level of human and animal health protection in accordance with requirements in Union legislation and to avoid any risk to the security of supply and to the safety of medicines and medical devices safety”.


Regulation will require specific labelling on packaging (Article 11 Labelling of packaging) containing information on its material composition in order to facilitate consumer sorting, packaging reusability, QR code or other type of data carrier giving access to the relevant information facilitating its re-use and that code shall facilitate the tracking of the packaging and the calculation of trips and rotations. This could present challenges to pharmaceutical manufacturers, mainly due to lack of space on packaging materials and technical reasons (primary packaging in contact with medicine).


The European pharmaceutical industry federation, EFPIA, has expressed caution over EU proposals to require more recycling and re-use of packaging materials. Pharmaceutical sector is one of the most highly regulated in Europe and the world, operating within an evidence-based framework to maintain the highest standards that ensured packaging never compromises patient safety or product effectiveness. Therefore, a need to carefully consider the requirements set for the sector to ensure continuous supply of medicines on the EU market will be necessary.


Next steps

After the publication of Regulation, it is up to the European legislators, the European Parliament and the Council, to adopt their respective positions under the ordinary legislative procedure. The legislators hope to reach an agreement by early 2024 to avoid a delay in adoption. There has already been pushback by some Member States and industry against strict reuse requirements. Separate to this, the Commission has also published an EU policy framework yesterday on biobased, biodegradable and compostable plastics. The communication, which does not contain specific legislative proposals, looks to create a coherent policy framework for these plastics through the use of existing legislation and standards. The framework identifies advantages to these plastics, such as waste prevention and the decoupling of fossil carbon from chemical processes, whilst also acknowledging several challenges to increased use of these materials, including labelling and contamination issues.