AnimalhealthEurope

Position paper April 2023 AnimalhealthEurope position paper on the proposal for a regulation on Packaging and Packaging Waste - COM (2022) 677 final. AnimalhealthEurope is the voice of the animal health industry. Together we protect the health and welfare of over one billion animals across Europe, including both farm and companion animals. The veterinary sector not only protects animal health but also contributes to protect public health and to the production of safe, affordable and sustainable food. We would like to take this opportunity to comment on the proposal for a regulation of the European Parliament and of the Council on Packaging and Packaging Waste (PPWR) (COM (2022)677final).

…regulation of the European Parliament and of the Council on Packaging and Packaging Waste (PPWR) (COM (2022)677final). Environmental sustainability is a very important societal objective, therefore AnimalhealthEurope aligns with the goals of the European Commission concerning the proposed PPWR such as harmonising national measures on packaging and the management of packaging waste, providing a high level of environmental protection and preventing the production of packaging waste. AnimalhealthEurope is fully committed to reduce waste and increase recyclability provided the availability and the quality - and hence safety and efficacy - of animal health products are not compromised. AnimalhealthEurope will also promote reuse of packaging items where technically possible and within the limits of supply chain feasibility.

…also promote reuse of packaging items where technically possible and within the limits of supply chain feasibility. General comments AnimalhealthEurope welcomes the proposal for a Regulation as a way to increase the harmonisation across Member States. However, we remain concerned that many provisions in the text would allow Member States to introduce specific and divergent national requirements which may present challenges for availability and the single market. The proposed targets on packaging minimisation, recycled content, reuse, and packaging formats restrictions should be assessed on their ability to deliver the best environmental outcome and with respect to quality, hygiene, health and safety requirements for medicines. While also ensuring the availability and supply of medicines.

…hygiene, health and safety requirements for medicines. While also ensuring the availability and supply of medicines. We strongly call on the co-legislators to strengthen the Commission’s proposal on the basis of robust data and life cycle analyses. While a clear timeframe for the adoption of secondary legislation is missing in many instances, a number of requirements will have to be implemented 12 months after the entry into force of the Regulation. We call on the establishment of exemptions for Ref. Ares(2023)2839730 - 21/04/2023 Position paper April 2023 2 www.animalhealtheurope.eu products that have already been packaged before the entry into force of the requirements (e.g. transitional periods and rules on exhaustion of stocks), as well as to ensure legal certainty for economic operators, including clear timeline for the adoption of secondary legislation.

…to ensure legal certainty for economic operators, including clear timeline for the adoption of secondary legislation. Specific comments For outer packaging and package leaflet of animal health products: AnimalhealthEurope members are already developing processes to reduce volume of packaging items, to design them for recycling and are starting to use recycled materials where possible. However, these changes will require time for the necessary development and approval as well as robustness in supply chains and availability of the required packaging materials. In some cases, the technology and/or alternatives are not available or not at sufficient scale/quantity to ensure supply. Also, we strongly support using e-leaflets (electronic pack leaflets) as soon as the necessary systems and IT tools (e.g.

…we strongly support using e-leaflets (electronic pack leaflets) as soon as the necessary systems and IT tools (e.g. Union Product Database) are in place and fully operational and there is alignment with medicines regulatory agencies and other stakeholder. The use of electronic leaflets in replacement of paper leaflets can contribute to reducing the global ecological footprint caused by the manufacture of veterinary medicines and the availability of electronic leaflets can also improve usage of products and accessibility of product information to the end user as well as support packaging minimisation. This will dramatically reduce waste. Finally, it is also recognised by PPWR that outer packaging, which is necessary to preserve the quality of the medicinal product, should be exempted from article 7.

…packaging, which is necessary to preserve the quality of the medicinal product, should be exempted from article 7. In the same order of ideas, exemption from article 6 should be extended in cases where secondary packaging is quality critical and has to comply with specific requirements to preserve the quality of the product. AnimalhealthEurope believes that the exemption should also include other materials that are not necessarily in direct contact with the product as sold but will contact the product before it is used, e.g. multidose livestock vaccines usually have a supplied sterile draw off tube assembly. This assembly is by necessity made of multiple materials due to the properties (flexibility, strength, etc) and key for use of the product. For immediate packaging: AnimalhealthEurope welcomes that the immediate packaging is exempted from recyclability requirements (article 6).

…welcomes that the immediate packaging is exempted from recyclability requirements (article 6). Unfortunately, this exemption is limited until 1 January 2035. The scientific rationale for this decision for exemption (Recital 24) is: “In order to protect human and animal health and safety, due to the nature of the packaged products...” In some cases, recycling of primary packaging has inherent risks due to the product toxicity, be that to humans or the environment (e.g. wastewater from rinsing). Or it has multiple components that cannot easily be separated for recycling (e.g. pre-filled syringes, coated stoppers, o-rings, plastic-aluminium flip-off caps or multi-layer blister packs).

(e.g. pre-filled syringes, coated stoppers, o-rings, plastic-aluminium flip-off caps or multi-layer blister packs). For these animal health products (as with some human health products alike) there will need to be an extension or open-ended exemption until technology can be developed to manage and mitigate these risks and challenges, the deadline needs to be replaced by a technological review timepoint. The intrinsic epidemiological, physiological and/or toxicological nature of the Veterinary Medicinal Product (VMP), active substance or other animal health product, that are in direct contact with the VMP or other animal health Position paper April 2023 3 www.animalhealtheurope.eu product, could compromise the objective of recyclability of packaging and go against the objectives of article 6.

…could compromise the objective of recyclability of packaging and go against the objectives of article 6. Moreover, according to Annex II, of Regulation 2019/6 (the relevant sectorial legislation), the immediate packaging of active substances and finished products are fully described and assessed, as well as having specific compendial requirements. Immediate packaging is defined in Annex II as an integral part of the product (e.g. composition, labelling, stability studies of the materials used) and as part of the set of requirements to be presented to the EMA (European Medicines Agency) or National Competent Authorities in the approval process of a VMP being released to the market (i.e. part of the data submission dossier).

Authorities in the approval process of a VMP being released to the market (i.e. part of the data submission dossier). Annex II requires a complete and detailed set of technical documentation (including packaging) necessary for demonstrating the quality, safety, efficacy and environmental safety of the product. The environmental risk assessment, amongst other, addresses the potential exposure of the environment arising from the disposal of unused product or other waste product. Furthermore, Article 117 of Regulation 2019/6, requires member states to ensure that appropriate systems are in place for the collection and disposal of unused, and waste from veterinary medicinal products.

…systems are in place for the collection and disposal of unused, and waste from veterinary medicinal products. AnimalhealthEurope believes that this exemption should be permanent and not limited in time and extended to other animal health products in addition to VMPs, these include diagnostic products, veterinary devices and feed additives which are all critical in supporting animal health. While it is acknowledged these do not all have sectorial specific legislation, they do often contain substances of environmental risk that require special disposal and/or are made of combinations of materials that cannot easily be separated for recycling. Packaging is an integral part of the product and therefore must be addressed under its respective legislation.

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originalus šaltinis (PDF) ↗

…9th January 2026 Page 1 of 2 AnimalhealthEurope comments to EC consultation on COMMISSION DELEGATED DECISION supplementing Regulation (EU) 2025/40 of the European Parliament and of the Council by exempting certain economic operators that use pallet wrappings and straps from the 100% reuse requirements of these packaging formats Draft Act setting exemptions for pallet wraps and straps. General objective: AnimalhealthEurope call the European Commission to take into consideration the need for further discussion with industry on specific needs for Veterinary Medicinal Products (VMPs) and ensuring continued availability of the products on the markets. Our proposed input towards the exemption for straps and wrapping is provided below:

…of the products on the markets. Our proposed input towards the exemption for straps and wrapping is provided below: 1. Acknowledgment of targeted exemptions The Animal Health Industry welcomes the Commission’s targeted exemption for pallet wrappings and straps. This measure reflects a pragmatic understanding of operational realities and environmental objectives. It will help maintain supply chain integrity for large-volume shipments while reducing unnecessary complexity.

It will help maintain supply chain integrity for large-volume shipments while reducing unnecessary complexity. 2. Need for additional time and guidance While supporting the overarching goals of PPWR, the Animal Health pharma Industry requires extended transition periods and clear guidance to implement reuse targets for cross-border packaging. Our products often involve very specific and specialized handling and compliance with veterinary regulations and/or Pharmacopeia guidelines, making immediate adaptation very challenging. A phased approach will be critical to avoid disruptions in product availability and ensuring proper customer service.

A phased approach will be critical to avoid disruptions in product availability and ensuring proper customer service. 3. Sector-Specific Challenges Animal Health products present unique logistical and regulatory constraints that complicate reuse requirements, e.g: • Temperature-Sensitive Vaccines Challenge: Strict cold chain (2–8°C and lower) must be maintained at all times. Reusable packaging must be validated for temperature control, and single-use insulation or cooling elements cannot be easily reused without compromising efficacy. • Sterile Injectable VMPs Challenge: Sterility and tamper-evident seals are essential. Reuse introduces contamination risks, requiring costly redesign and validation. • Pharma actives, Hazardous or Controlled Substances Example: Sedatives, euthanasia solutions, cytotoxic agents Ref. Ares(2026)229894 - 09/01/2026 9th January 2026 Page 2 of 2 Challenge:…

…solutions must be robust, easy to clean, and compatible with diverse logistics routes.

…long- haul transport. Reusable solutions must be robust, easy to clean, and compatible with diverse logistics routes. 4. Request for Impact Assessment and Cost Analysis We urge the Commission to conduct a granular impact assessment on the cost and competitiveness of implementing reuse targets in Animal Health. While the Deloitte study provides a useful baseline, further analysis is needed to: • Quantify compliance costs for specialized packaging. • Assess implications for companies and global competitiveness. • Identify feasible reuse models without compromising product integrity.

…for companies and global competitiveness. • Identify feasible reuse models without compromising product integrity. 5. Advocate for Industry Dialogue and Regulatory Flexibility We recommend ongoing engagement between the Commission and Animal Health stakeholders to monitor implementation and address emerging challenges. Regulatory flexibility is essential, including: • Extended transition periods for complex product categories. • Alternative compliance pathways for products with validated safety and sterility requirements. • Periodic review mechanisms to adapt requirements based on technological progress and risk assessments. Conclusions The Animal Health Pharma Industry fully supports the environmental objectives of PPWR but emphasizes the need for a specific to the needs, phased and risk-based approach that safeguards product integrity, animal health, and customer service.…

originalus šaltinis (PDF) ↗