Association of the European Self-Care Industry

Association of the European Self-Care Industry 7 avenue de Tervuren Tel : + 32 2 735 51 30 [email protected] 1040 Brussels, Belgium Fax : + 32 2 735 52 22 www.aesgp.eu Packaging policies fit for environment protection and circular economy: the specificities of pharmaceutical packaging created for patient safety AESGP position on Packaging and Packaging Waste Directive Review In light of the current impact assessment conducted by the European Commission to support the review of Directive 94/62/EC on Packaging and Packaging Waste which regulates the placing on the market of packaging as well as packaging waste prevention and management, AESGP would like to share some specificities of medicinal products’ packaging. The protection of the environment is indeed paramount and all stakeholders have a role to play.

…products’ packaging. The protection of the environment is indeed paramount and all stakeholders have a role to play. Medicines are not exempt of this responsibility and Pharmaceutical Industry has long worked on optimizing packaging, where possible, to suit the patient needs and their safety. The pharmaceutical industry has been answering to global environmental concerns and has set up an eco-pharmaco-stewardship project which includes a campaign to raise awareness about the correct disposal of medicinal products in the various EU Member States.

…a campaign to raise awareness about the correct disposal of medicinal products in the various EU Member States. Packaging and labelling for medicines is heavily regulated for the safety of patients When thinking of packaging and labelling of medicinal products, many considerations are taken into account, so that these support the safe use and convey the appropriate information to patients, as well as ensure the protection of medicines properties, ideally throughout a long shelf-life. Quality management systems are in place which take into account the following elements: ▪ the requirements of the European and national authorities and the relevant legislation; ▪ the characteristics of the medicine itself; ▪ the production process; ▪ the ability to support proper information and safe use of medicines; ▪ the particular manufacturers’ quality policies.

…ability to support proper information and safe use of medicines; ▪ the particular manufacturers’ quality policies. The use of GMP and quality control ensure the quality of the final product to the patient. Packaging processes and equipment need validation/qualification in the same way as any other part of processing within a pharmaceutical facility. In the production chain, quality control for packaging contains several critical points which ensure safety of the final product. Studies on possible extractables and leachables1 that could damage the performance of a product, for instance, will limit the variety of contact material that can be used. Primary packaging materials have been in the focus of such investigations for a long time as the contact time between the medicine itself and packaging material is rather long.

…investigations for a long time as the contact time between the medicine itself and packaging material is rather long. In the very rare cases where packaging is defective, because it can create problems and have serious consequences, systems are in place for detection and may result in, e.g., medicines being recalled. Directive 2001/83/EC sets up requirements for the primary packaging. A description of the container and the closure system(s) including the identity of each immediate packaging material and their specifications shall be provided in the Marketing authorization application. The specifications shall 1 The kind of leachable you would have to look for can vary from organic oligomers and catalyst residues to heavy metals. Ref. Ares(2021)139333 - 07/01/2021 AESGP Press release on EU Pharmaceutical Strategy | Page 2 of 3 include description and identification.

- 07/01/2021 AESGP Press release on EU Pharmaceutical Strategy | Page 2 of 3 include description and identification. Non-pharmacopeial methods (with validation) shall be included where appropriate. For non-functional outer packaging materials, only a brief description shall be presented. Secondary packaging has to be provided to the authorities as mock-up before approval. Also, both packaging and labelling of medicinal products need to portray essential legal information and legal safety features, under precise rules such as wording and legibility sizes. The European Medicines Agency's scientific guidelines on the packaging of medicinal products help medicine developers prepare marketing authorisation applications for human medicines. There are several guidelines including on plastic primary packaging materials.

…applications for human medicines. There are several guidelines including on plastic primary packaging materials. This one in particular requires packing material data from extraction studies, interaction studies (which include sorption and migration studies) as well as toxicological information and documentation. Pharmaceutical industry already optimises packaging to keep (direct and indirect) environmental impact and costs to a minimum Pharmaceutical companies have worked to ensure that packaging is reduced to a possible minimum under continuous improvement and optimization processes, to prevent overpackaging and to avoid waste.

…possible minimum under continuous improvement and optimization processes, to prevent overpackaging and to avoid waste. This optimisation of the packaging material is a compromise between the size of the contents, its stability during the supply-chain, safety (e.g., child-proof measures) and the regulatory requirements at both national and European level on packaging and labelling information. By keeping each pack to a minimum volume and weight, Pharmaceutical Industry can optimize transport of great quantities of product with reduced transport carbon footprint and reduced costs on distribution. Reflection is ongoing to improve recyclability of packaging materials for pharmaceuticals. Medicines already have adapted pack sizes according to their different uses The principles of appropriate use of medicines are taken into consideration when presenting a range of pack sizes for a medicine.

…of appropriate use of medicines are taken into consideration when presenting a range of pack sizes for a medicine. According to European Commission guidelines, the appropriate range of pack sizes is decided in accordance with the duration of the treatment in the given indication and in accordance with the posology in the summary of product characteristics and not in accordance with local traditions or prescription habits. Some pack sizes are adapted to short courses of treatment, as they aim at episodical symptoms. This is already the case for many OTC medicines, preventing waste of left-over medicines and privileging availability for convenience of use. Fractioning industrial packaging brings added challenges to environment and patients Solutions that aim at fractioning the industrial packaging of medicines do not bring any benefit to environmental concerns of package reduction.

…the industrial packaging of medicines do not bring any benefit to environmental concerns of package reduction. Individual dose dispensing systems usually take up human resources and costs of operating a professional technical service, with charges that need to be borne by the patient or health system payer (e.g., insurer). Moreover, these systems will involve repackaging and use of extra material resources as well as the reprinting of labels and patient information material, to abide to European legislation that protects patients and consumers. Opening and repackaging medicines is time consuming and, when not done under good pharmaceutical practices, can be a source of contamination, product deterioration, safety, non-observance and medication errors.

…practices, can be a source of contamination, product deterioration, safety, non-observance and medication errors. The legal requirements to provide a patient information leaflet and other information material could also involve printing at the point of sale (e.g. pharmacy) where a printing operation may have a stronger environment impact than when it is levied by the manufacturer. Disposal of medicines is #MedsDisposal In accordance with Article 127b of Directive 2001/83/EC, Member States shall ensure that appropriate collection systems are in place for medicinal products that are unused or have expired. European countries have thus transposed the requirement and have special medication disposal schemes in place in order to prevent pharmaceutical residues from building up in water courses.

…medication disposal schemes in place in order to prevent pharmaceutical residues from building up in water courses. Where take-back schemes are in place, Product Responsibility Organizations ensure the collection of expired and unused AESGP Press release on EU Pharmaceutical Strategy | Page 3 of 3 medicines and often make use of reverse logistics through the medicine’s distribution channels. According to the different models in place according to Member-State these products can be domestically sorted for the recyclable parts and then collected or directed to triage and recycling after collection. Ultimately, non-recyclable or contaminated medicine waste will be routed to incineration for the return of energetic value.

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Association of the European Self-Care Industry 7 avenue de Tervuren Tel : + 32 2 735 51 30 [email protected] 1040 Brussels, Belgium Fax : + 32 2 735 52 22 www.aesgp.eu AESGP Response to the Feedback Procedure on the Commission Proposal for a Regulation on Packaging and Packaging Waste AESGP, the Association of the European Self-Care Industry, represents the manufacturers of non- prescription medicines, food supplements, and self-care medical devices in Europe, an area also referred to as “self-care” or “consumer healthcare” products. AESGP welcomes the opportunity to provide feedback on the Commission Proposal for a Regulation on Packaging and Packaging Waste (PPWR).

…opportunity to provide feedback on the Commission Proposal for a Regulation on Packaging and Packaging Waste (PPWR). Given its transversal application to all packaging, AESGP recognizes the clear implications it will have on the Self-Care sector and looks forward to having an open and transparent dialogue with all relevant stakeholders to achieve a framework that proactively addresses the adverse impact of packaging and packaging waste on the environment and human health. GENERAL CONSIDERATIONS AND COMMENTS • AESGP welcomes the choice of a Regulation as a legal instrument and an internal legal market basis (Article 114 TFEU) to encourage effective harmonisation between Member States, thus facilitating an effective EU circular economy.

TFEU) to encourage effective harmonisation between Member States, thus facilitating an effective EU circular economy. Maintaining the legal market basis in its entirety is crucial to prevent market fragmentation and the establishment of barriers hindering the free movement of packaged goods, including consumer healthcare products, within the EU. In this context, we are concerned that certain provisions (e.g. Article 4) will allow Member States to maintain or introduce specific requirements at the national level. • Several provisions in the proposal depend on the adoption of implementing and delegated acts.

…at the national level. • Several provisions in the proposal depend on the adoption of implementing and delegated acts. In some cases, such as in Article 6 (4), which refers to the official methodology to calculate packaging recyclability and complying with the design for recycling criteria, and which is to be adopted through a delegated act, no specific timelines are provided for the adoption of the secondary legislation. To ensure legal certainty and promote transparency for economic operators, and considering the strict requirements that must be met by consumer healthcare products to guarantee their safety, quality, and efficacy, we call for the inclusion of clear timelines regarding the adoption of secondary legislation, where not specified.

…we call for the inclusion of clear timelines regarding the adoption of secondary legislation, where not specified. In addition, we believe it is of importance to include a general clause that applies in situations where the secondary legislation is not adopted within the specified timelines and provides for additional transitional period(s) for economic operators corresponding to the delay of the secondary legislation. Ref. Ares(2023)2888344 - 24/04/2023 Association of the European Self-Care Industry AESGP Feedback on COM Proposal for a Regulation on PPWD 24/04/2023 | Page 2 of 6 • With reference to sectorial legislation applying to consumer healthcare products1, strict and high requirements relating to packaging are established primarily to ensure safety and efficacy.

…products1, strict and high requirements relating to packaging are established primarily to ensure safety and efficacy. Consequently, requirements introduced by the EU’s horizontal regulatory framework for packaging and packaging waste must be coherent with existing requirements detailed in sectorial legislation, without creating any conflicts. SPECIFIC CONSIDERATION AND COMMENTS • Recyclable Packaging – Article 6 The regulation requires that packaging shall be recyclable by 2030, and medicines packaging, as well as contact sensitive packaging of medical devices, by 2035. Packaging is considered recyclable if it meets specific performance grades for a design-for-recycling (DfR). The recycling rate of the packaging must be above 70% (level A-D), packaging with performance grade E, where less than 70% of the packaging is recyclable, will be banned from 2030.

A-D), packaging with performance grade E, where less than 70% of the packaging is recyclable, will be banned from 2030. Timelines Although the overall ambitions of the proposal are commendable, there are serious concerns about the timelines established in the proposal. DfR guidelines must be based on science and established in close collaboration with relevant stakeholders. Regular reviews of the DfR guidelines must be done to consider scientific and societal developments. Connecting recyclability grades to proportionate EPR fees will be one of the main drivers for packaging recyclability. According to the proposal, the performance grades will be established by secondary legislation. This legislation must be in force by 2025 to meet the 2030/2035 targets because it would take 3-5 years to fully roll out a commercially available packaging solution.

…the 2030/2035 targets because it would take 3-5 years to fully roll out a commercially available packaging solution. We strongly encourage the Commission to reconsider the timelines or alternatively specify them together with industry, once the secondary legislation has been established, with a minimum of 5 years to comply for non-pharmaceutical packaging and 10 years for pharmaceutical packaging. Where there is no technically recyclable solution commercially available at scale that ensures the quality, safety and efficacy of the product, we encourage the EU to help fund innovation to speed up the development of new solutions. For example, cold and flu medicines are packaged in non-recyclable materials such as polyethylene (PE) with an aluminium barrier layer or PVC/PVdC.

…are packaged in non-recyclable materials such as polyethylene (PE) with an aluminium barrier layer or PVC/PVdC. Alternative recyclable materials which could provide an equivalent barrier are not commercially available today and it is expected to take 10-15 years for these to arrive to the market for consumer healthcare products. 1 Non-prescription medicines are subject to Directive 2001/83/EC. Self-care medical devices are subject to Regulation (EU) 2017/745 on medical devices. Food supplements are subject to Directive 2002/46/EC relating to food supplements and other legislative acts applicable to food in general, such as Regulation 178/2002 laying down the general principles and requirements of food law.

…to food in general, such as Regulation 178/2002 laying down the general principles and requirements of food law. Association of the European Self-Care Industry AESGP Feedback on COM Proposal for a Regulation on PPWD 24/04/2023 | Page 3 of 6 Medical devices Concerning medical devices, packaging made of non-plastic materials, such as glass and paper, are commonly used. Accordingly, the exemption for medical devices in Article 6 (10) (b) should not be limited to contact sensitive plastic packaging but instead, extend to cover all packaging materials, thus being material neutral. On that basis, additional time should be granted before recyclability requirements become applicable should be granted. Small size packaging collection and sorting A lot of healthcare products are supplied in small size packaging such as tablet blisters and single dose sachets due to regulatory requirements.

…are supplied in small size packaging such as tablet blisters and single dose sachets due to regulatory requirements. Even if these were made from recyclable materials, this packaging size is not always collected, sorted, and recycled across Member States. This translates into this type of packaging not being detected in sorting facilities and being counted as “non-recyclable”, despite being fully designed-for-recycling. Economic operators supplying products to the market can ensure they are recyclable but have no control over the collection, sorting, and effective recycling of small healthcare packaging. This must be matched by innovation in recyclability so that, for example, small size packaging can be collected, sorted, and recycled. If packaging of medicinal products is recyclable due to its material properties (according with Art.

…and recycled. If packaging of medicinal products is recyclable due to its material properties (according with Art. 6) but cannot be covered by the recycling infrastructure due to its size, the producer should not be unduly burdened within the framework of the EPR. • Minimum Recycled Content in Plastic Packaging – Article 7 Article 7 requires that a plastic packaging component contains a certain proportion of recycled plastic by 2030 and 2040. The requirement applies “per unit” of packaging. In the case of pharmaceuticals and medical devices, packaging material must meet extensive quality and safety standards, which can only be achieved through long term safety and stability testing.

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