D2.2 ILSs mapping

Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Research Executive Agency (REA). Neither the European Union nor the granting authority can be held responsible for them. 1 ILSs mapping /D2.2 WP2. ANIPH project baseline, T2.2-Setting the basis for ANIPH effective contribution to ILSs (Information & labelling system(s)) Authors: Rick Passenier (GO!PHA); Maximilian Lackner (GO!PHA); Saloni Sharma (GO!PHA); Anindya Mukherjee (GO!PHA); Alba Matamoros (KVC); Èvelyne Dussault (KVC); Juan Antonio Pavón Losada (KVC); Cristina Vera (KVC) ANIPH-Deliverable 2.2. ILSs Mapping. VF Funded by the European Union 2 Technical references Project Acronym ANIPH Project Title Avoiding the Negative Impacts produced by Plastic materials in Humanitarian contexts Project Coordinator ASOCIACION EMPRESARIAL DE INVESTIGACION CENTRO TECNOLOGICO DEL CALZADOY DEL PLASTICO DE LA REGION DE MURCIA CETEC Carmen Fernández: c.fer[email protected] Project Duration January 2025 – December 2028 (48 months) Deliverable No. D2.2 Dissemination level* PU - Public Work Package WP 2 - WP ANIPH project baseline Task T2.2 - Setting the basis for ANIPH effective contribution to ILSs Lead beneficiary 6 (GOPHA) Contributing beneficiary/ies 7 (KVC), 7.1 (KVC-ES) Due date of deliverable 30 September 2025 Actual submission date 03 October 2025 ● *PU – Public, fully open, e.g. web (Deliverables flagged as public will be automatically published in CORDIS project’s page) ● SEN – Sensitive, limited under the conditions of the Grant Agreement ● Classified R-UE/EU-R – EU RESTRICTED under the Commission Decision No2015/444 ● Classified C-UE/EU-C – EU CONFIDENTIAL under the Commission Decision No2015/444 ● Classified S-UE/EU-S – EU SECRET under the Commission Decision No2015/444 ANIPH-Deliverable 2.2. ILSs Mapping. VF Funded by the European Union 3 V Date Comments Author/Reviewer V0 02/09/2025 First draft of document Rick Passenier (GO!PHA), Alba Matamoros and Cristina Vera (KVC) V1 12/09/2025 Revised version based on the comments of the internal reviewer 1 Rick Passenier (GO!PHA), Alba Matamoros and Cristina Vera (KVC), Carmen Fernández Ayuso (CETEC), Marianna Kotzabasaki (AUA), Konstantina Filippou (AUA) V2 13/09/2025 Revised version based on the comments of the internal reviewer 2 Maximilian Lackner (GO!PHA), Cristina Blaya V3 19/09/2025 Final revision for approval by Coordinator Rick Passenier (GO!PHA), Saloni Sharma (GO!PHA) V4 30/09/2025 Pre-Final version for final approval Carmen Fernández Ayuso (CETEC), Rick Passenier (GO!PHA) VF 03/10/2025 Final version Carmen Fernández Ayuso (CETEC), Rick Passenier (GO!PHA) ANIPH-Deliverable 2.2. ILSs Mapping. VF Funded by the European Union 4 Table of Contents Table of Contents ................................................................................................................................. 4 List of Tables ......................................................................................................................................... 5 List of Figures ....................................................................................................................................... 5 List of Abbreviations ............................................................................................................................ 7 Executive Summary .............................................................................................................................. 9 Purpose .................................................................................................................................... 9 Key Findings ............................................................................................................................. 9 Relevance for ANIPH ................................................................................................................ 9 Next Steps .............................................................................................................................. 10 1. Introduction ................................................................................................................................... 11 1.1. Relevance of Information and Labelling Systems (ILS) ......................................................... 11 1.2. Goals of ILS in the ANIPH project .......................................................................................... 12 1.2.1. Understanding the current system .............................................................................. 12 1.2.2. Identifying gaps and inconsistencies ........................................................................... 12 1.2.3. Towards a usable and tailored system ........................................................................ 12 1.2.4. Recommendations for the field ................................................................................... 13 1.3. Scope and Boundaries of the Mapping Exercise ................................................................... 13 1.3.1. Scope ............................................................................................................................ 13 1.3.2. Boundaries ................................................................................................................... 14 1.4. Methodology ......................................................................................................................... 14 2. ILS Inventory ................................................................................................................................... 16 2.1. Map of the different information and labelling systems ...................................................... 16 2.2. Standards, Certification, and Substantiating Claims ............................................................. 16 2.2.1. European-level standards and certifications ............................................................... 17 2.2.2. International standards and certifications................................................................... 19 2.2.3. Certifications Bodies and Labelling Initiatives ............................................................. 20 2.3. Sector-specific ILSs (medical, humanitarian, packaging) ...................................................... 22 3. Overview of topics concerned with current ILS ............................................................................. 24 3.1. Environmental Dimensions ................................................................................................... 24 3.2. Social Dimensions ................................................................................................................. 25 3.3. Economic Dimensions ........................................................................................................... 25 3.4. Technical Dimensions ............................................................................................................ 26 ANIPH-Deliverable 2.2. ILSs Mapping. VF Funded by the European Union 5 4. ILS gap analysis ............................................................................................................................... 27 4.1. Overview of gaps that form adoption barriers ..................................................................... 27 5. ILS components relevant for ANIPH products and specification of data points ........................... 29 5.1. Key Data Requirements for ANIPH Materials and Products ................................................. 29 5.2. Priority SSbD Indicators for ILS Alignment ............................................................................ 30 5.3. Technical Specifications for Feedstocks and Additives ......................................................... 30 6. Strategy to further obtain relevant data/information in other WPs ............................................. 32 6.1. WP4 and WP5 – Safety and Performance of Materials ........................................................ 32 6.2. WP8 and WP11 – Safety and Performance of Products ....................................................... 33 6.3. WP9 – Safety and Performance of the End-of-life System ................................................ 34 7. ILSs from the Consumer Perspective ............................................................................................. 35 7.1. Consumer awareness & understanding of ILSs .................................................................... 35 7.2. Consumer perception & attitudes towards ILSs ................................................................... 36 7.3. Consumer behaviour towards ILSs........................................................................................ 38 7.4. Communication Needs for ILSs ............................................................................................. 39 8. Conclusion ...................................................................................................................................... 41 List of References ............................................................................................................................... 43 List of Tables Table 1. Selected CEN standards related to ANIPH BBpPs and packaging. 17 Table 2. Selected International standards related to ANIPH BBpPs and packaging 20 Table 3. Environmental aspects in current ILS 23 Table 4. Social aspects in current ILS 24 Table 5. Economic aspects in current ILS 24 Table 6. Technical aspects in current ILS. 25 Table 7. Overview of identified gaps in current ILS 26 Table 8. Key data requirements for ANIPH materials and products 28 Table 9. Priority SSbD indicators relevant for ANIPH. 29 Table 10. Technical specifications for feedstocks and additives 30 Table 11. Data contribution from WP4 and WP5 31 Table 12. Data contribution from WP8 and WP11 32 ANIPH-Deliverable 2.2. ILSs Mapping. VF Funded by the European Union 6 Table 13. Data contribution from WP9 33 List of Figures Figure 1. Methodological flow of the ILS mapping exercise. 14 Figure 2. ILS relations to product, system, and user specifics. 15 ANIPH-Deliverable 2.2. ILSs Mapping. VF Funded by the European Union 7 List of Abbreviations Acronym Full Form ANIPH Avoiding the Negative Impacts produced by Plastic materials in Humanitarian contexts (EU project) ASTM American Society for Testing and Materials BBpPs Biobased biodegradable plastics products CEN European Committee for Standardization DoA Description of Action DPP Digital Product Passport ESPR Ecodesign for Sustainable Products Regulation FTC Federal Trade Commission GCD Green Claims Directive ILS Information & labelling system(s) ISO International Organization for Standardization LCA Life Cycle Assessment MDR Medical Device Regulation MSF Médecins Sans Frontières ANIPH-Deliverable 2.2. ILSs Mapping. VF Funded by the European Union 8 OECD Organisation for Economic Co-operation and Development PHA Polyhydroxyalkanoates PQ Prequalification PPWR Packaging and Packaging Waste Regulation REACH Registration, Evaluation, Authorisation and Restriction of Chemicals SSbD Safe and Sustainable by Design UDI Unique Device Identifier UNHCR United Nations High Commissioner for Refugees VFA Value for Action WHO World Health Organization WP Work Package ANIPH-Deliverable 2.2. ILSs Mapping. VF Funded by the European Union 9 Executive Summary This deliverable provides a systematic mapping of existing Information and Labelling Systems (ILS) relevant to biobased and biodegradable plastic products (BBpPs), with a focus on their application in medical wound care products and packaging for humanitarian contexts. The work forms part of ANIPH Work Package 2, task 2.2 and establishes the foundation to information and labelling system for subsequent activities on Safe and Sustainable by Design (SSbD), data generation, and policy contribution. Purpose The objective was to identify which standards, certifications, tests, and labels currently apply to BBpPs and medical packaging, to assess their coverage of environmental, social, economic, and technical aspects, and to define how ANIPH can contribute to their future development. The mapping provides clarity on existing requirements, highlights inconsistencies, and identifies how and where data should be recovered from. The focus is on the EU. Key Findings ● Comprehensive technical coverage exists for safety, sterility, and some performance tests through EU Medical Device Regulation (MDR), EN, ISO, and ASTM standards. ● Environmental coverage is relatively strong for controlled biodegradation and compostability, but weak for real-world disposal scenarios such as open burning or unmanaged landfills, which are common in humanitarian settings. ● Socio-economic aspects are underrepresented in current ILS. Procurement frameworks seldom integrate sustainability criteria, cost-performance data for BBpPs is scarce, and existing labels are not always accessible to low-literacy or multilingual user groups. ● Systemic barriers include inconsistent terminology across standards (EN, ISO, ASTM, national), limited transparency in certification schemes, and a lack of alignment between labels and actual waste management infrastructure. Relevance for ANIPH For wound care products and packaging in humanitarian operations, these gaps highlight the need for a tailored ILS framework that integrates: ANIPH-Deliverable 2.2. ILSs Mapping. VF Funded by the European Union 16 standards, a presumption of conformity applies. Standards demonstrate compliance and support the implementation of legal mandates, as well as substantiating information shared about product features voluntarily as general sector and/or global practice. ● Certification Schemes and labelling: Proving conformity to standards is displayed by getting labels or certificates from accredited bodies. Certification bodies like TÜV Austria and DIN CERTCO are trusted and accredited for carrying out specific tests detailed in standards to issue labels and certificates and demonstrate compliance. ● Substantiating Claims: Claims regarding marketing, environmental, and health performance, whether a regulatory requirement or voluntarily shared, increasingly require backing with scientific data and proof of conformity. 2.2.1. European-level standards and certifications At the European level, regulatory and standardisation frameworks apply both to medical products and to their packaging. For wound care products in humanitarian contexts, both layers are relevant. The Medical Device Regulation (MDR 2017/745) sets the baseline for the medical product 1 . It requires that labels include safety information, traceability, and instructions for correct use and disposal. It also specifies that information must be comprehensible to both professional and nonprofessional users, which is particularly relevant in emergency and humanitarian settings. [1] The new Packaging and Packaging Waste Regulation (PPWR), currently under preparation for implementation, will specify technical requirements for compostable packaging. It addresses design requirements, recyclability, and mandatory labelling obligations to align with the principles of a circular economy. The regulation introduces harmonised disposal and material identification labels across the EU, aiming to reduce consumer confusion and improve waste management. [5] The EU Ecolabel is a voluntary certification scheme that can apply to a wide range of products, including packaging. While it is not specific to medical products, it provides principles for 1 In the European Union, the classification of medical devices is governed by the Medical Device Regulation (MDR) (EU) 2017/745, which has been fully applicable since 26 May 2021 (it replaced the old Medical Devices Directive 93/42/EEC and Active Implantable Medical Devices Directive 90/385/EEC). Medical devices are divided into four risk-based classes: 1. Class I – Low risk; Examples: bandages, non-invasive instruments, spectacles. 2. Class IIa – Low-to-medium risk; Examples: hearing aids, infusion pumps, dental fillings, surgical gloves. 3. Class IIb – Medium-to-high risk; Examples: ventilators, anesthesia machines, bone fixation plates. 4. Class III – Highest risk; Examples: pacemakers, heart valves, implantable defibrillators, breast implants. ANIPH-Deliverable 2.2. ILSs Mapping. VF Funded by the European Union 17 transparency and verifiable claims (e.g. biodegradability, recyclability) that may serve as a reference when designing sustainable wound care packaging. [6] The EU Green Claims Directive (GCD) could act as a complementary framework to the Medical Device Regulation (MDR) and Packaging and Packaging Waste Regulation (PPWR) to substantiate voluntary claims with clear, scientifically-backed evidence by an independent, accredited thirdparty. The European Committee for Standardization (CEN) develops technical standards that primarily concern packaging materials. For example, EN 13432 defines requirements for packaging recoverable through composting and biodegradation. [7] Table 1. Selected CEN standards related to ANIPH BBpPs and packaging. Standard Focus Relevance for ANIPH EN 13432 (2000) Compostability and biodegradability of packaging Ensures claims about compostable packaging are verifiable; relevant for disposal of wound care packaging in contexts with composting options. It is the most common standard. EN 14995 (2006) Compostability of nonpackaging plastics Extends compostability testing beyond packaging; relevant for product components or accessories in BBpPs. EN 15593 (2008) Hygiene management in packaging production Ensures sterile packaging production; transferable to medical packaging safety. EN 17033 (2018) Biodegradable plastics in soil (mulch films) Provides test methods and biodegradation benchmarks; useful for assessing degradation under uncontrolled disposal conditions. EN 13427 (2004) and related standards Packaging and environment (prevention, reuse, recycling, recovery) Framework for sustainable packaging design; aligns with EU waste directives, relevant for policy and procurement of BBpPs. Comment: For biobased carbon content, the most relevant standard, based on the radiocarbon method, is ASTM D6866 ”Standard Test Methods for Determining the Biobased Content of Solid, Liquid, and Gaseous Samples Using Radiocarbon Analysis”. ANIPH-Deliverable 2.2. ILSs Mapping. VF Funded by the European Union 18 2.2.2. International standards and certifications At the international level, several standardisation organisations define requirements relevant to information and labelling of biobased and biodegradable plastic products (BBpPs). These include the International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM International), and the Organisation for Economic Co-operation and Development (OECD). Each provides methods and frameworks that support comparability of data, certification schemes, and product claims. ISO Standards ● Medical products: ISO 15223-1 [8] specifies symbols to be used on medical device labels, packaging, and information supplied, to create global consistency in safety and use instructions. ISO 11607-1 and ISO 11607-2 [9] cover requirements for packaging of terminally sterilized medical devices, including design, materials, and validation of sterile barriers. ● Packaging and environmental aspects: ISO 17088 [10] specifies procedures and requirements for compostable plastics, while ISO 14855-1 and ISO 14855-2 [11] define methods for determining ultimate aerobic biodegradability of plastics under controlled composting conditions. ISO 14021 [12] covers environmental labels and self-declared claims, such as “compostable” or “biodegradable,” and provides guidelines to avoid misleading statements. ASTM Standards ASTM is another body which creates American standards. Sometimes the ASTM standards are also internationally recognized and adopted. ● ASTM D6400 [13] defines requirements for labelling plastics as compostable in municipal or industrial facilities. ● ASTM D5338 [14] provides a test method for determining aerobic biodegradation of plastic materials under controlled composting conditions. ● ASTM D6954 [15] outlines a standard guide for exposing and testing plastics that degrade in the environment by a combination of oxidation and biodegradation. US FDA ● Humanitarian Device Exception [16]: Label must state that federal approval is only indicative of device/product’s humanitarian use, not its effectiveness. ANIPH-Deliverable 2.2. ILSs Mapping. VF Funded by the European Union 19 OECD Guidelines OECD test guidelines are primarily designed for chemical testing but are widely used in the context of BBpPs. Of particular relevance are biodegradation tests such as OECD 301 (ready biodegradability) and OECD 302 (inherent biodegradability) [17]. These guidelines are often referenced by certification bodies as they provide internationally recognized methods for assessing environmental fate. International standards provide a system of methods and requirements that complement European frameworks. For medical wound care packaging, ISO standards on symbols and sterile barrier systems are directly applicable to ensure usability and compliance in international humanitarian operations. For environmental aspects, ISO, ASTM, and OECD biodegradation standards provide the basis for claims about compostability or degradability, which must be verified before such claims are communicated in humanitarian contexts. 2.2.3. Certifications Bodies and Labelling Initiatives A variety of certification bodies and eco-labels exist for BBpPs. These are often operated by independent certification bodies, industry associations, or NGOs. They are widely used on packaging and consumer products, and in some cases extend to medical packaging materials. Certification Bodies: ● TÜV Austria (OK Compost / OK Biodegradable / OK Compost Home) [18] o Certifies compostability under industrial or home conditions. o “OK Biodegradable” variants exist for soil, marine, and freshwater environments. ● DIN CERTCO (Germany) o Operates certification for compostable plastics based on EN 13432 and related standards. o Includes labels for biobased carbon content (measured against C14 analysis). [19] ● BPI Certification (North America) [20] o Biodegradable Products Institute certification, based on ASTM standards. o Widely used for consumer packaging, recognised in municipal composting facilities. Voluntary labelling Initiatives: ● EU Ecolabel (voluntary, public scheme) [21] o Covers a wide range of products, including packaging, with strict environmental performance criteria. ANIPH-Deliverable 2.2. ILSs Mapping. VF Funded by the European Union 20 ● USDA Certified Biobased [22] o The U.S federal voluntary label indicates that the product has been certified by the US Department of Agriculture (USDA) to contain the percent biobased content as shown on the label. ● Blue Angel (Germany) [23] o Environmental label covering paper, plastics, and packaging, focusing on recyclability and reduced environmental impact. Table 2. Selected International standards related to ANIPH BBpPs and packaging [18-23]. Standard Focus Relevance for ANIPH Requirement / Voluntary ISO 152231:2021 Symbols on medical device labels Ensures wound care packaging carries globally recognised safety/use symbols. MDR, FDA Requirement ISO 116071/2:2019 Packaging for sterilised medical devices Defines sterile barrier system requirements; critical for medical packaging. MDR, FDA Requirement ISO 17088:2021 Specifications for compostable plastics Provides baseline for claims on compostability of packaging materials. EU (PPWR) requirement ensure proper EoL management ISO 148551/2 Biodegradability in composting Standard test methods; relevant for validating ANIPH product claims. Voluntary ISO 14021:2016 Environmental selfdeclared claims Prevents misleading terms (“biodegradable”, “compostable”) in labels. Voluntary ASTM D640021 Labelling compostable plastics Widely used outside the EU; relevant for international acceptance of ANIPH packaging. Supporting ANIPH-Deliverable 2.2. ILSs Mapping. VF Funded by the European Union 21 ASTM D533821 Biodegradation test method Aligns with ISO biodegradation methods; comparability check required. Supporting ASTM D695418 Plastics degrading by oxidation + biodegradation Covers materials exposed to open environments; relevant for uncontrolled disposal. Supporting OECD 301/302 Ready and inherent biodegradability Referenced in many ecolabels; useful benchmarks for ANIPH end-of-life pathways. Supporting Other notable labels include ÖKOTEX [24] and EMAS [25]. These are broader and hence not detailed further. 2.3. Sector-specific ILSs (medical, humanitarian, packaging) There are sector-specific frameworks that guide information and labelling practices in health and humanitarian contexts. These are crucial for ANIPH, since wound care products and their packaging must meet medical safety requirements while also being usable in low-resource emergency environments. Medical Device Labelling ● EU Medical Device Regulation (MDR 2017/745) [1] requires labelling of all medical devices with: o Safety and risk information. o Traceability codes (UDI – Unique Device Identifier). o Clear instructions for professional and non-professional users. ANIPH-Deliverable 2.2. ILSs Mapping. VF Funded by the European Union 22 ● ISO 15223-1 and ISO 20417 provide globally harmonised symbols and requirements for medical device information, ensuring labels are recognisable across regions. [8] Humanitarian Procurement Frameworks ● WHO and UNICEF procurement guidelines specify product information requirements for wound care products and infection prevention materials. [26] ● UNHCR and Médecins Sans Frontières (MSF) logistics standards include instructions on packaging, labelling, and shelf-life communication for medical supplies in emergencies. [27] ● Emphasis is placed on: o Rapid identification of product type and expiry. o Durability of labels under extreme conditions (heat, humidity, transport). o Multilingual or symbol-based instructions for diverse user groups. Packaging Initiatives in Healthcare ● Sterility and hygiene: Packaging must maintain barrier properties and be labelled with sterilisation method, expiry, and handling precautions (ISO 11607). [9] ● Waste management guidance: Labels increasingly include instructions for segregation. [28] ANIPH-Deliverable 2.2. ILSs Mapping. VF Funded by the European Union 23 3. Overview of topics concerned with current ILS Current ILS address a range of dimensions. They include environmental, social, economic, and technical aspects. Their practical value depends on local context. 3.1. Environmental Dimensions ILS places strong emphasis on environmental performance, particularly for biobased and biodegradable plastics. Standards and certifications cover: ● Biodegradability and compostability under controlled conditions. ● Recyclability and recycling material codes. ● Life-cycle indicators such as biobased origin. ● End-of-life pathways, aligned with available infrastructure. Table 3. Environmental aspects in current ILS Aspect Typical ILS standard or requirement Example certifier or label Relevance for ANIPH Biodegradability and compostability EN 13432, ISO 17088, ASTM D6400, FTC Green Guides (US) DIN CERTCO, BPI, OK Compost Key for wound care packaging claims; must be validated under realistic disposal conditions. Relevant in case industrial or home composting facilities exist; limited applicability in humanitarian settings. Recyclability PPWR Blue Angel, recycling codes Useful in regions with established collection/recycling; less practical in emergency contexts without infrastructure. Carbon content Biobased content certification DIN CERTCO Supports SSbD and transparency; relevant for reporting and procurement. ANIPH-Deliverable 2.2. ILSs Mapping. VF Funded by the European Union 24 3.2. Social Dimensions Social aspects receive less attention in current ILS, but some frameworks address usability and accessibility. Table 4. Social aspects in current ILS Aspect Typical ILS Coverage Relevance for ANIPH Symbol use ISO 15223-1, CE Mark (in MDR) [29] Essential for multilingual humanitarian contexts, CE mark is often used in international procurement too. Acceptability WHO/UNICEF procurement, EU ESPR (Digital Product Passport) Ensures trust and adoption by field workers and endusers. For visibility and integrity of product information 3.3. Economic Dimensions Economic dimensions are embedded in procurement frameworks or eco-label criteria rather than standalone standards. ● Procurement requirements: Standards and certifications are often mandatory in tenders. ● Market influence: Labels influence buyer decisions and credibility. Table 5. Economic aspects in current ILS Aspect Typical ILS Coverage Relevance for ANIPH Procurement criteria WHO PQ/UNICEF specs, EU tenders Determine eligibility for humanitarian supply chains. Market influence EU Ecolabel, Blue Angel, MDR CE Mark, ESPR Digital Product Passport (DPP), EU Green Claims Directive Boosts credibility and supports wider adoption. Claims Substantiation EU Green Claims Directive, FTC Green Guides (US) Provides evidence of device feature/property claims ANIPH-Deliverable 2.2. ILSs Mapping. VF Funded by the European Union 25 3.4. Technical Dimensions Technical requirements form the most developed part of current ILS, especially for medical devices and packaging. ● Safety and sterility: Core requirement in medical frameworks. ● Toxicology and material testing: Addressed through OECD and ISO standards. ● Performance validation: Includes barrier properties, shelf life, and usability. ● Traceability: Unique identifiers and coding systems for medical supply chains. Table 6. Technical aspects in current ILS. Aspect Typical ILS Coverage Relevance for ANIPH Safety & sterility MDR, ISO 11607 Critical for wound care packaging. Toxicology OECD, ISO, REACH Needed for Safe-and-Sustainable-by-Design evaluation. Performance ASTM, EN ISO packaging tests Ensures products function reliably under stress conditions. Traceability MDR UDI Supports accountability and logistics in humanitarian operations. Aspect Typical ILS Coverage Relevance for ANIPH Safety & sterility MDR, ISO 11607 Critical for wound care packaging. Toxicology OECD, ISO, REACH Needed for Safe-and-Sustainable-by-Design evaluation. Performance ASTM, EN ISO packaging tests Ensures products function reliably under stress conditions. Traceability MDR UDI Supports accountability and logistics in humanitarian operations. ANIPH-Deliverable 2.2. ILSs Mapping. VF Funded by the European Union 32 Traceability Unique Device Identifier (UDI) coding integration (MDR CE Mark, FDA Clearance) Enables global recognition and logistics tracking. 6.2. WP8 and WP11 – Safety and Performance of Products The data requirement from WP8: ‘small scale manufacturing of ANIPH products and biodegradation/properties predictive assessment at product level (wound dressing + packaging)’ and WP11: ‘safe and sustainable end-of-life and safety assessment at product level’ focuses on validation of wound dressing product and packaging characteristics and performance under realworld humanitarian and healthcare conditions. ● Usability and acceptability by health workers and end-users. ● Performance under emergency conditions (heat, humidity, transport stress). Table 12. Data contribution from WP8 and WP11 Aspect Data Generated Relevance for ILS Usability User feedback on clarity of labels, handling Adapt labelling for low-literacy or stressed environments. Acceptability Perception by health workers, patients Guides trust and adoption of labelled claims. Field performance Function under transport, climate, storage Ensures instructions reflect actual conditions of use. ANIPH-Deliverable 2.2. ILSs Mapping. VF Funded by the European Union 33 6.3. WP9 – Safety and Performance of the End-of-life System The data requirement from WP9: ‘end-of-life assessment (biodegradation and recyclability validation) in lab, simulated and real conditions’ focuses on safety and performance of the end-oflife system. ● Disposal pathways and actual end-of-life behaviours. Table 13. Data contribution from WP9 Aspect Data Generated Relevance for ILS End-of-life Observation of disposal practices Provides evidence for realistic wasterelated labelling. ANIPH-Deliverable 2.2. ILSs Mapping. VF Funded by the European Union 34 7. ILSs from the Consumer Perspective ILSs are frameworks that help consumers choose, use, and dispose of products, including more (or less) sustainable products [31], [32]. The Circular Economy Action Plan highlights the need to ensure that a product labelled as ‘biodegradable’ does not mislead consumers and lead them to dispose of it in a manner that causes plastic littering or pollution due to unsuitable environmental conditions or insufficient degradation time [2]. As such, ANIPH aims to address the lack of sufficiently developed or tailored ILSs for BBpPs to favour their adoption and inform consumers. The present chapter aims to review the literature concerning consumer awareness and understanding, perception and attitudes, and behaviour as well as communication needs related to ILSs in the specific context of sustainable health-related packaging. It aims to inform an approach that fosters social acceptability of BBpPs by consumers, including health care professionals, social care professionals, and citizens. It covers literature from 1981 to 2025. Sources were selected from academic databases (i.e., Scopus, Web of Science, PubMed) and institutional reports (i.e., European Commission, OECD). Complementary grey literature (e.g., industry white papers, etc.) was also included to capture emerging trends and applied perspectives. 7.1. Consumer awareness & understanding of ILSs The current lack of standardisation of ILSs for sustainable products contributes to consumer confusion [33], [34] This is reflected in a European survey that found that while 71% of respondents expressed a desire to purchase more sustainable products, the majority of them were unable to correctly identify which packaging options were more environmentally friendly [35]. In the context of the food industry, an analysis of the German retail food market demonstrated how most of a set of 14 labels and claims about the sustainability of products were not accurate, transparent, or comprehensible [36]. These sustainability claims were substantiated by a puzzling variety of data sources and methodologies displayed on products. This lack of accuracy, transparency, and comprehensibility adds to consumers’ difficulty in understanding environmental attributes such as recyclability or biodegradability. In the context of health care, even if consumers prefer bio-based plastic medical devices over conventional medical devices, many of them have incorrect associations with bio-based plastic products (e.g., only 55.3% of all participants in a survey selected ‘Made from biomass’) [37]. In medical packaging, ILSs must adhere to strict regulatory requirements (e.g., Regulation (EU) 2017/745 on medical devices [1]) in addition to being ANIPH-Deliverable 2.2. ILSs Mapping. VF Funded by the European Union 35 understandable to consumers – health professionals, social care professionals and non-professional users alike – who may have little time and cognitive resources to read and interpret ILSs. In the context of medical products, a lack of understanding can have more serious consequences, especially for non-professional users [38], [39]. Home users are often elderly or informal caregivers who may struggle with interpreting technical instructions or graphics on labels. Generally, users with adequate literacy levels do not do well when interpreting auxiliary labels: only 37% were found to give correct interpretations [39]. A study aiming to develop easy-to-understand prescription auxiliary labels assessed existing labels and concluded that they were also hard to comprehend for adults with low literacy: less than 50% ‘excellent’ interpretations were given for the labels, except for two of them [40]. For the new labels the authors designed, the use of graphics, increased font size, and coloured background most improved understanding. The authors recommended not to use text that exceeds a sixth-grade level to meet the needs of consumers with low literacy. Indeed, accessibility is a recurrent concern that should be taken into consideration when designing ILSs that support consumers in making informed choices. Elderly users and users with disabilities often face barriers in interpreting packaging despite regulatory efforts, highlighting the need for ILSs that are tailored to real-life cognitive and visual capacities of different user groups [41]. The integration of virtual smart labelling and QR codes that redirect to audio descriptions and other mobile-supported features is helpful, especially when combined with a human-centred design approach [42], [43]. 7.2. Consumer perception & attitudes towards ILSs ILSs do more than conveying information to users. They influence how consumers think about their choices and evaluate products, in turn impacting the market [32], [44]. Labels can highlight values like protecting the environment, shaping consumer perception and attitudes [45]. Even when pursuing similar values, ILSs may differ in standards and the resonance they achieve among their target consumers. They can vary in how strict they are, what values they focus on, and how much trust people have in them [32], [46] As such, a label is only useful if people believe it is trustworthy. That trust depends on who is responsible for the certification, how effectively it is disseminated to society, how clear standards are, and how carefully products are inspected. There is growing interest in sustainability issues among consumers, with positive consequences on the perception of and attitudes towards eco-labels [47] For instance, a large-scale field experiment in fashion e-commerce found that eco-labels can have a positive effect on consumer purchases [48]. Consumers seemed to perceive those labels as a positive extrinsic cue. Nonetheless, some labelling factors impact willingness to pay for some non-medical products. First, a meta-analysis demonstrated that participants in 35 discrete choice experiments reported a willingness to pay ANIPH-Deliverable 2.2. ILSs Mapping. VF Funded by the European Union 36 more for foods with an eco-label, especially when a product had an organic label compared with other more specific environmental sustainability labels [49]. This might be because organic labels have a much longer history compared with other environmental sustainability labels, increasing consumer trust and familiarity with organic labels. This shows that the perceived legitimacy of the institution behind the label can impact consumer perception and attitude. Claims supported by public authorities, standardised certification schemes, or reputable associations are perceived as more trustworthy [50]. Unclear affiliations or marketing-driven icons tend to cause scepticism. Without standardised ILSs, consumers must learn or interpret new icons with each product [33], [34]. Detailed, transparent labelling strengthens consumers’ perceptions of product safety and brand responsibility, particularly in food and health care contexts [51]. To this effect, standardisation at the EU level has been called for by industry and consumer organisations alike to foster consistency and ease of use [52]. Second, this meta-analysis also found that a combination of text and logo was linked with higher willingness to pay than those employing one or the other. Third, a discrete choice experiment found that participants showed higher willingness to pay for products that employed multi-level labels, hinting at a preference for colourful multi-levels labels and their perceived benefits over binary black-and-white design [51]. Nevertheless, there is a caveat to this finding: participants also preferred products with a multi-level label that were negatively evaluated over products with no label, hinting at a limited effectiveness of eco-labels. Consumers may perceive colourful multi-level labels as better even when they reflect a negative health or environmental evaluation. Finally, the use of multiple labels can backfire as demonstrated by market research into extra-virgin olive oil using a discrete choice experiment [53]. It found that, while the use of two labels had a positive interaction effect, the use of three labels led to label exhaustion, impairing consumer understanding, diminishing the perceived value of verified attributes, and in turn decreasing willingness to pay. In the context of medical products, including wound dressings, packaging and ILSs have the potential to shape attitudes towards product safety and sustainability as interfaces between the producer and the consumer [43]. There are several factors that can influence consumer perception and attitudes of sustainable medical products. First, packaging that integrates labels with inclusive design elements (i.e., design of products that are accessible to and usable by as many people as possible without special adaptation or specialised design [54]) such as large fonts, tactile cues, colour coding, and audio-readable QR codes tends to be more widely accepted across diverse user groups [42]. This is particularly relevant for elderly users, users with visual impairments, and users with low literacy. Ease of manipulation (i.e., opening, resealing, etc.) also contributes to the perception of the packaging as helpful rather than obstructive. Then, ambiguity and inconsistency between messages communicated on labels of BBpPs, such as when they indicate recyclability ANIPH-Deliverable 2.2. ILSs Mapping. VF Funded by the European Union 37 despite the material not being accepted in local waste streams, or when a product has an outer compostable layer but a non-recyclable sterile inner pouch [33] can lead to scepticism over BBpPs. Efforts should be made to improve the clarity and reliability of communications to consumers regarding the source of the material, how the waste is processed, and how to dispose of the material [33], [55]. Ideally, those communications would also include information about availability of alternatives and their implications (e.g., fossil plastic products; eco-labels may be more effective when they are contrasted against negative labels for products that are environmentally harmful [56]) to promote informed decisions, and targeted information about local waste management systems so that consumers know how to dispose of the product and are not left with the impression that biodegradability equates license to litter in the open environment when proper waste management is available. 7.3. Consumer behaviour towards ILSs Despite growing attitudinal support for sustainable consumption, sustainable behavioural change among consumers remains limited [57]. A persistent challenge in sustainable consumption is the gap between expressed intention and behaviour. For example, while over 70% of consumers reported preferring sustainable packaging options, this does not consistently affect their purchasing patterns [35]. The behavioural reasoning theory helps explain this gap, showing that even positive attitudes towards sustainability must overcome competing reasons against sustainable behaviour (e.g., cost, habit, perceived risk, etc.) to influence intention and innovation adoption [58]. According to this theory, behaviour is shaped by intention which is shaped by beliefs and values, reasons for and against the behaviour, and motives (i.e., attitude, subjective norm, perceived control). This section investigates key barriers and enablers to translating consumer attitudes into action. In health care, consumers may agree that eco-friendly products are preferable yet still choose cheaper or more familiar options, particularly under time pressure or when dealing with medical uncertainty [33], [34]. Importantly, purchasing decisions are not only made by health care professionals or end users: medical providers and health care centres significantly shape the availability, affordability, and perceived legitimacy of products, thereby influencing how end users interact with, and trust medical devices [59]. Unclarity of ILSs is a primary barrier for behavioural change. If consumers struggle to interpret terms like “compostable” or “biocompatible,” their likelihood of using the information in decision-making drops. In health-related packaging, this becomes even more salient due to the stressful context of use (e.g., emergency wound dressing changes). Labels that provide concise, well-positioned information [43] and avoid technical jargon are more likely to lead to behaviour change [60]. Moreover, the presence of many labels can lead ANIPH-Deliverable 2.2. ILSs Mapping. VF Funded by the European Union 38 to a sense of saturation resulting in selective inattention where important safety or disposal instructions are ignored. Cognitive load increases with each additional claim, especially under time pressure. Many factors can shift behaviour to be more sustainable. First, social influence has an impactful effect on behaviour as consumers are influenced by the presence, expectations, and behaviours of social others [57]. For instance, through social identities, consumers can be encouraged to engage in sustainable actions if other in-group members (e.g., neighbours, colleagues, etc.) also perform them [61], [62]. Interventions based on peer influence or social proof such as caregiver testimonials linked to ILSs can increase uptake of sustainable choices. Second, habit is another critical component of sustainable behaviour change: many common habits like resource use and disposal of products are strongly habitual [57]. Since breaking habits is viewed as effortful, making an action easier to do is a good strategy to encourage sustainable habit formation [63]. Requiring less sorting of recyclables and placing recyclable bins in an accessible and visible space in health care environments would be useful contextual cues for increasing sustainable habit formation in addition to clear disposal instructions in ILSs [64]. Finally, tangibility is another useful component [57]: communications that relate to more proximal consequences of sustainable behaviours for a given neighbourhood, city, or region can make action and outcomes seem more tangible and relevant (e.g., highlighting current issues like extreme weather [65] [66]. 7.4. Communication Needs for ILSs This last section aims to provide actionable recommendations to design ILSs so that they positively impact consumer awareness and understanding, consumer perception and attitudes, and consumer behaviour. First, to increase consumer awareness and understanding across consumer groups of different abilities, ILSs should: ● Include accurate, transparent, and comprehensible sustainability claims, claims for a product class should be substantiated by the same data sources and methodologies. ● Establish correct associations with bio-based plastic medical devices (e.g., ‘made from biomass’. ● Use graphics, increased font size, and coloured background in addition to avoiding text that surpasses a sixth grade reading level. ● Integrate virtual smart labelling and QR codes that redirect to audio descriptions and other mobile-supported features. ANIPH-Deliverable 2.2. ILSs Mapping. VF Funded by the European Union 39 ● Elaborate on the absence of persistent microand nanoplastics when biobased and biodegradable alternatives and substitutes like PHA are used, particularly in the critical context of healthcare. Second, to improve consumer perception and attitudes, ILSs should: ● Use a simple, standardised certification scheme with institutional backing to boost consumer trust and familiarity and prevent them having to relearn new ILSs for different products. ● Include a logo along with text. ● Avoid the use of more than two labels to avoid label exhaustion that diminishes the perceived value of verified attributes. ● Be combined with packaging that follows inclusive design principles ● Provide clear and reliable information regarding the source of the material, how the waste is processed, and how to dispose of the material, as well as information about availability of alternatives to promote informed decisions. ● Provide localised information about waste management systems so that consumers know how to dispose of the product. Lastly, to bridge the gap between consumer intention and behaviour, ILSs should: ● Be supported by dissemination strategies to medical providers and health care centres as the latter can influence availability, affordability, and perceived legitimacy of BBpPs. ● Provide concise, well-positioned, and direct instructions that enable appropriate behaviour and avoid technical jargon and excessive use of labels to prevent instructions from being ignored. ● Capitalise on social influence by having professional consumers influence other professional and non-professional consumers around them to engage in more sustainable behaviour. ● Facilitate new habit formation by being combined with waste management systems that require less sorting of recyclables and that provide the appropriate bins placed in visible locations in health care environments. ● Capitalise on tangibility by relating to BBpPs’ sustainability in terms of minimisation of adverse proximal environmental consequences. ANIPH-Deliverable 2.2. ILSs Mapping. VF Funded by the European Union 40 8. Conclusion The mapping of information and labelling systems (ILS) shows that a wide range of standards, certification schemes, and eco-labels already exist at European and international levels. These provide a useful foundation for assessing biobased and biodegradable plastic products (BBpPs), including wound care packaging. However, the review also reveals limitations. Current ILSs are largely oriented towards conventional consumer packaging or controlled industrial contexts and do not fully address the specific requirements of medical devices or the realities of humanitarian settings. Three main areas of gaps have been identified. On the technical side, there is insufficient standardisation for PHA materials and their additives, and existing biodegradation tests focus on industrial conditions rather than open or low-infrastructure environments. On the environmental side, gaps remain in harmonised life-cycle data and in accounting for realistic end-of-life pathways such as open dumping or burning, which are common in crisis situations. The socio-economic dimension is underrepresented, with limited integration of procurement criteria, low awareness of BBpPs among buyers, and insufficient attention to accessibility and comprehensibility of labels for diverse user groups. These gaps are reinforced by systemic issues such as inconsistent claims across regions, lack of transparency in certification, and poor alignment with local waste management infrastructure. For the ANIPH project, these findings highlight the need for a tailored ILS framework that integrates Safe and Sustainable by Design (SSbD) indicators, technical specifications, environmental performance, and user-centred communication. The outputs of this mapping exercise provide the baseline for subsequent work packages. WP4 will generate robust safety and performance data, WP9 will validate usability and end-of-life aspects in real humanitarian contexts, and WP11 will support the translation of results into standardisation and policy. This deliverable therefore plays a bridging role. It establishes the reference point for evaluating BBpPs against existing ILS, identifies where new evidence is required, and frames the design of a system that can communicate safety, sustainability, and usability in an integrated way. The outcomes will directly feed into D11.5 (Final ANIPH contributions to ILSs), which will consolidate the project’s recommendations for standardisation and labelling frameworks, and D12.1 (Final report on policy briefs/recommendations), which will translate these findings into policy-oriented ANIPH-Deliverable 2.2. ILSs Mapping. VF Funded by the European Union 41 guidance. Together, these contributions will support the development and adoption of safe and sustainable wound care products and packaging solutions for humanitarian contexts, reinforcing both environmental responsibility and societal value. ANIPH-Deliverable 2.2. ILSs Mapping. VF Funded by the European Union 48