In 2021, every EU citizen generated around three times their body weight in packaging waste. Thereby, the Germans occupy an uncomfortable second place among the EU’s packaging waste producers and are therefore well above the average. And it is steadily increasing: the total amount of packaging waste in the EU was 66 million tonnes in 2009, rising to 84 million tonnes in 2021. By contrast, the recycling rate fell by three percentage points between 2017 and 2021 (source: Eurostat).
This trend is now set to end – a new regulation on packaging and packaging waste (PPWR), which aims to reduce the volume of waste and increase the recycling rate, is awaiting final adoption by the Council. To this end, manufacturers and distributors are to be held more accountable. If the PPWR comes into force, we will have to fundamentally rethink the matter of packaging – even medical technology will not be able to avoid changes.
PPWR at a glance
Back in 2020, the EU paved the way for a revision of European waste legislation with the Circular Economy Action Plan. In April 2024, the EU Parliament voted in favour of the PPWR. Formal approval by the Council is now pending before the law is expected to be published in the Official Journal of the EU at the beginning of 2025 and enter into force 20 days later. It will apply 18 months after entry into force. During the same period, the Commission will issue implementing acts to regulate the specific handling of individual content.
As it is a regulation, the PPWR applies directly in every member state. It applies to all companies based in the EU and to companies that import products into the EU. This means that the medical technology sector is also affected. However, there are some exceptions and transitional provisions in the small print, which are discussed below.
The most important regulations summarised
- Requirements for substances in packaging: The use of lead, cadmium, mercury and hexavalent chromium in packaging will be limited and the ECHA is to review further bans. Material compliance is therefore becoming even more important.
- Recyclable packaging: Progressive minimum standards are set for the recyclability of packaging, with which eco-modulated fees are calculated.
- Minimum proportion of recycled materials: The use of recycled materials, particularly for plastic packaging, is to be increased through progressive minimum quotas.
- Reduction of packaging waste: Packaging must be designed according to specific design criteria in such a way that volume and weight are reduced. Certain packaging is subject to a maximum proportion of empty space.
- Reusable packaging: The use of reusable packaging, especially for transport packaging, is regulated by minimum quotas.
- Labelling and information obligations: Environmental labels are harmonised at European level and labelling obligations are imposed on economic operators.
- Use of authorised representatives: Companies that ship packaging material to EU member states and are based outside the EU must designate an authorised representative.
- Declarations of conformity: Economic operators must make declarations of conformity in a national register and draw up technical documentation.
- Extended manufacturer obligations: Packaging manufacturers must contribute financially to the life cycle costs of packaging.
Exemptions for medical technology
Name Image: Primary packaging of medical devices
Article 6 sets out requirements for the recyclability of packaging. Secondary raw materials produced must be of sufficient quality compared to the source material so that they can be used as a substitute for primary raw materials. In three categories, the recyclability of packaging will be raised in stages by 2038 with minimum specifications. Medical devices in accordance with Regulation (EU) 2017/745 and in-vitro diagnostics in accordance with Regulation (EU) 2017/746 are exempt from this regulation until 1 January 2035. After this date, their applicability will be reviewed again.
Article 7 stipulates a minimum percentage of recycled material in various types of plastic packaging from 2030, which will be increased in stages. Contact-sensitive plastic packaging for medical devices, products intended exclusively for research purposes and test products covered by Regulation (EU) 2017/745 as well as in-vitro diagnostics in accordance with Regulation (EU) 2017/746 are exempt from this regulation. Contact-sensitive packaging is defined as packaging that is used for products that fall within the scope of Regulations (EU) 2017/745 – MDR and (EU) 2017/746 – IVDR, among others. The extent to which the various packaging levels up to the shipping box are affected should be checked accordingly.
Article 11 sets out requirements for the labelling of packaging. A harmonised system is adopted by means of an implementing act. For example, labelling is prescribed for the material composition, compostability, reusability and recycled content of the packaging.
Furthermore, content must be retrievable via a QR code or other digital data carrier. If other Union law – for example the MDR – stipulates that information on the packaged product must be provided by means of a data carrier, a single data carrier must be used to provide the information required for the packaged product and for the packaging.
Article 11 shall not apply to the primary packaging and the outer packaging within the meaning of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) if there is no space on the packaging due to other labelling requirements within the meaning of the above-mentioned legislation or if the labelling of the packaging could compromise safe use.
The extent to which Article 11 will be compatible with the UDI code or may not be applicable due to safety concerns will only be determined on the basis of the implementing regulation on this topic, which is still to be finalised.
The outlook for a new era of packaging
With the new PPWR, the traceability of packaging throughout its life cycle must be guaranteed. It is best to ask yourself the question now: Do you know the entire path of your packaging – even before a product is stored in it? Some exceptions have been made for medical technology, but our industry will not be able to avoid adapting the design of packaging at all.
We will be happy to support you in the identification and implementation of new sustainability regulations, the design of sustainable products and the competent training of your staff with our portfolio of services relating to sustainable medical technology.
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