DuPont de Nemours International SARL

…1 24 April 2023 DuPont position on the draft Packaging and Packaging Waste Regulation Key messages: 1. Keep Regulation as the legal basis for the packaging legislation 2. Extend exemption of medical packaging from the recycled content targets in Art. 7 to the supply chain to include critical raw materials, parts, and components delivered to the medical and pharmaceutical industries. 3. Add digital label in Art. 11 to communicate sustainability characteristics such as the share of recycled content and reuse. 4. DuPont supports the use of mass balance in Art.

…characteristics such as the share of recycled content and reuse. 4. DuPont supports the use of mass balance in Art. 7 and the calculation of recycled content targets per economic operator Keep Regulation as the legal basis for the packaging legislation DuPont operates in 12 Member States in Europe and uses B2B packaging to deliver products and solutions to our customers in electronics, next generation automotive, water, personal protection, and industrial technologies. We source packaging materials globally and operate cross-borders in Europe. Recently, multiple Member States have adopted divergent national rules on packaging such as Spain (Spanish Decree 1055/2022 on Packaging and Packaging Waste, Spanish Plastic Tax), France (Anti- waste law for a circular economy, AGEC) and Italy (Legislative Decree no. 116 on packaging).

Tax), France (Anti- waste law for a circular economy, AGEC) and Italy (Legislative Decree no. 116 on packaging). The fragmented rules across 27 different Member States make it difficult for companies to comply in a timely and cost-efficient way and leverage the benefits of the EU Single Market. The consequence of non-compliance for packaging leads, in some cases, to business discontinuity or damaging customer relationship. In addition, the speed and complexity at which the divergent national rules have been adopted does not leave sufficient time for companies to organize themselves internally, to set up the organizational structure (resources and people) and acquire the competence to understand what data needs to be reported and how the design of the packaging needs to be changed. Ref.

…competence to understand what data needs to be reported and how the design of the packaging needs to be changed. Ref. Ares(2023)2891540 - 24/04/2023 2 24 April 2023 Divergent packaging requirements in different EU Member States create a patchwork of small and less impactful solutions. Instead, we believe that a harmonization of the rules can make a bigger cumulative impact for the Green Deal and the EU Circular Economy Strategy compared to individual national initiatives on circularity of packaging. Therefore, we strongly support “Regulation” as the legal basis for the packaging legislation. We believe that this will provide for the much-needed harmonization of packaging rules across Europe, more legal/compliance certainty for companies and will enable better cross-border trade within Europe. Extend exemption of medical packaging from the recycled content targets in Art.

…cross-border trade within Europe. Extend exemption of medical packaging from the recycled content targets in Art. 7 to the supply chain to include critical raw materials, parts, and components delivered to the medical and pharmaceutical industries. DuPont supplies materials for healthcare packaging applications to keep medical equipment and pharmaceuticals sterile throughout their lifecycle. The Company has been a trusted choice for medical device and pharmaceutical manufacturers as well as specialized sterile packaging suppliers worldwide for decades. As an important extension of that role, we are actively working to advance sustainability across the healthcare packaging value chain.

…extension of that role, we are actively working to advance sustainability across the healthcare packaging value chain. DuPont also supplies performance materials that impact a broad range of advanced healthcare applications in three key healthcare markets - biopharmaceutical processing, pharmaceutical solutions, and medical devices. DuPont welcomes the exemption of medical and medicine packaging from the recycled content targets in Art. 7. We would like to extend this exemption to investigational and research use only medical devices as well as critical raw materials, parts, and components delivered to the medical and pharmaceutical industries which must comply with specific requirements to preserve the quality of the product.

…and pharmaceutical industries which must comply with specific requirements to preserve the quality of the product. Amendment 1 Article 7, paragraph 3, point (b) European Commission Proposal Proposed Amendment (b) contact sensitive plastic packaging of medical devices covered by Regulation (EU) 2017/745; (b) contact sensitive plastic packaging of medical devices, or devices of similar applications used for research use only and 3 24 April 2023 investigational devices covered by Regulation (EU) 2017/745; Justification: The proposed amendments seek to extend the scope of the exemptions granted for medical technologies packaging under Article 6 and Article 7 to include similar applications for research use only and investigational devices.

…under Article 6 and Article 7 to include similar applications for research use only and investigational devices. It is necessary to ensure that packaging for investigational and research use only devices, are not subject to requirements that may impede their safe and effective use in clinical trials or research settings.

…are not subject to requirements that may impede their safe and effective use in clinical trials or research settings. Amendment 2 Article 7, paragraph 3, point (e) and (f) (new) European Commission Proposal Proposed Amendment (NEW) (e) sales packaging of supplies of medical technologies’ components, materials, and parts covered by Article 117 of Regulation (EU) 2017/745 (f) sales packaging of supplies, components, raw materials, converted materials, packaging materials, cleanroom clothing systems, accessories, and parts for the manufacture of medicinal products under Directive 2001/83/EC and under Regulation (EU) 2019/6 for veterinary medicinal products where such packaging is necessary to comply with specific requirements to preserve the quality of the medicinal product.

…such packaging is necessary to comply with specific requirements to preserve the quality of the medicinal product. Justification: These exemptions should also be extended to sales packaging of critical supplies of medical technologies’ components, materials, and parts covered by Medical Devices Regulation (MDR) Article 117 as well as for the manufacture of medicinal products under Directive 2001/83/EC and veterinary medicinal products under Regulation (EU) 2019/6. These materials, parts, and components delivered to the medical and pharmaceutical industries must comply with specific requirements to preserve the quality of the product. The packaging used to protect these products will have similar requirements and be part of the medical device conformity assessment and certification of medicinal or veterinary products.

…and be part of the medical device conformity assessment and certification of medicinal or veterinary products. By explicitly extending the scope of existing exemptions for medical technologies packaging, the amendment would ensure that these products remain available, and that patient safety is not compromised. Allow the use of digital label in Art. 11 to communicate sustainability characteristics DuPont uses global supply chains to source packaging. To comply with emerging national labelling requirements for B2B packaging, the company welcomes opportunity to use a digital label as an 4 24 April 2023 alternative to a physical label in order to communicate sustainability characteristics such as recycled content or reuse(e.g., Italian Legislative Decree no. 116 on packaging, CONAI guidance on the use of digital channels for labels).

…reuse(e.g., Italian Legislative Decree no. 116 on packaging, CONAI guidance on the use of digital channels for labels). Amendment 3 Article 11, paragraph 3 European Commission Proposal Proposed Amendment Where a unit of packaging covered by Article 7 is marked with a label containing information on the share of recycled content, that label shall comply with the specifications laid down in the relevant implementing act adopted pursuant to Article 11(5) and shall be based on the methodology pursuant to Article 7(7).

21 → 12

originalus šaltinis (PDF) ↗