MTE update on the EU Packaging and Packaging Waste Regulation. MTE has worked hard for specific derogations (contact sensitive packaging) and extended timelines to address the issue of packaging traceability, and the need for the recycling market (specifically plastics (chemical) recycling ) to mature and meet sector requirements.
To: STC, Circular Economy WG and TF PPWR
Dear members,
Please be informed that the Council (with 25 Member States in favour and two abstentions) has today finally approved the revised Packaging and Packaging Waste Regulation (PPWR) –
please see Council press release here and the finally adopted legal text here
We are now awaiting publication of the PPWR in the Official Journal of the EU, which will determine the important dates of entry into force and applicability of its provisions, i.e.:
- The new PPWR will enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
- It shall apply from 18 months from the date of entry into force of this Regulation. However, the amendments brought to the Single Use Products Directive (EU) 2019/904 via Article 67(5) of the new Packaging Regulation will apply from 48 months from the date of entry into force of this Regulation.
- Further transitional arrangements are set for the existing articles 5(2), 5(3), 6(1) points (d) and (e), 6a, 8(2), 9(1) and 9(2) with regard to Annex II, point1, first indent of the existing Packaging Directive 94/62/EC.
- By 8 years from the date of entry into force of this Regulation, the Commission shall carry out a general evaluation of the entire Regulation and table a report with amendments, if appropriate, to the EP and Council.
- To be noted that 1.1. 2028 and 1.1.2035 will be important interim dates for the evaluation of medtech specific derogations granted (please see next paragraph).
We recapture important gains of MedTech Europe and its members in the negotiation process and thank you once again for the joining of forces on this critical matter:
- Article 6.11 and 6.12 – 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 – 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 – 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 laid down in this 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.
- At trade fairs, exhibitions or similar events, Member States shall not prevent the showing of packaging which does not comply with this Regulation, provided that a visible sign clearly indicates that such packaging does not comply with this Regulation and that it is not for sale until it has been brought into conformity.
