On 24 April, the plenary of the European Parliament approved the final provisional agreement on the Packaging and Packaging Waste Regulation (PPWR).
The EP’s endorsement of the following elements of the agreement reached with the Council:
- Article 6.11 and 6.12 (renumbered) – recyclability/recycling of scale:
- A material neutral approach is enacted for the following medtech specific derogation from newly introduces recyclability and recycling of scale requirements until (at least) 1 January 2035:
- contact sensitive packaging of medical devices covered by Regulation (EU) 2017/745; and
- contact sensitive packaging of in vitro diagnostic medical devices covered by Regulation (EU) 2017/746.
- By 1 January 2035, the Commission shall review the exceptions under paragraph 11 taking into account, at least, the evolution of sorting and recycling technologies and practical experience gained by the economic operators and Member States. On this basis, it shall assess the appropriateness of their continuity and, where necessary, present a legislative proposal.
- A material neutral approach is enacted for the following medtech specific derogation from newly introduces recyclability and recycling of scale requirements until (at least) 1 January 2035:
- Article 7.4 (renumbered) – recycled content: The newly introduced minimum recycled content requirements in plastic packaging shall, among other, not apply for:
- contact sensitive plastic packaging of medical devices, devices exclusively destined for research use and investigational devices covered by Regulation (EU) 2017/745; and
- contact sensitive plastic packaging of in vitro diagnostic medical devices covered by Regulation (EU) 2017/746.
By 1 January 2028, the Commission shall assess the need for derogations from the minimum percentage laid down in paragraph 1, points (b) and (d), for specific plastic packaging, or for the revision of the derogation established under paragraph 4 for specific plastic packaging.
- Article 15.11 (renumbered) – labelling: An exemption from obligations on manufacturers regarding conformity assessment and technical documentation requirements for “custom-made transport packaging for configurable medical devices and medical systems that are to be used in industrial and healthcare environments”.
- Article 4 – free movement: Packaging shall only be placed on the market if it complies with the new Regulation.
- Member States shall not prohibit, restrict or impede the placing on the market of packaging that complies with the sustainability, labelling and information requirements set out in Articles 5 to 12.
- If Member States choose to maintain or introduce national sustainability requirements, or information requirements additional to those laid down in this Regulation, those requirements shall not conflict with those of the Regulation and the Member States shall not prohibit, restrict or impede the placing on the market of packaging that complies with this Regulation for reasons of non-compliance with those national requirements.
The EP press release can be found here.
Next steps:
- As a final formal step, the Council now needs to formally approve the agreement before it can be published in the Official Journal of the EU and enter into force.
- The new Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the EU. It shall apply as of 18 months from the date of entry into force.
