VinylPlus Healthcare brings together the European PVC value chain to support safe, reliable and more sustainable healthcare applications.
This FAQ addresses common health, technical, environmental and regulatory questions related to PVC in medical devices, pharmaceutical packaging and wider healthcare applications.
All answers are based on European regulatory frameworks, scientific assessments, and published research. For further information, explore our Knowledge Hub.
General
What is vinyl?
Vinyl is short for polyvinyl chloride and is made from salt and ethylene. Also known as PVC, it is one of the most widely used plastics in the world, with applications across various industries.
Vinyl is the most used plastic in building & construction, such as window frames, water pipes, flooring, and cables. In healthcare, it is essential for a wide range of disposable medical devices, pharmaceutical packaging, hospital infrastructure, emergency and rescue equipment, and more.
For more information about vinyl’s history, production, physical properties and the industry’s sustainable development, visit pvc.org and vinylplus.eu.
What is PVC?
PVC is short for polyvinyl chloride and is made from salt and ethylene. Also known as vinyl, it is one of the most widely used plastics in the world, with applications across various industries.
PVC is the most used plastic in building & construction, such as window frames, water pipes, flooring, and cables. In healthcare, it is essential for a wide range of disposable medical devices, pharmaceutical packaging, hospital infrastructure, emergency and rescue equipment, and more.
For more information about PVC’s history, production, physical properties and the industry’s sustainable development, visit pvc.org and vinylplus.eu.
Is PVC and vinyl the same?
The terms PVC and vinyl are both short for polyvinyl chloride, but their usage has varied geographically and over time.
Traditionally, PVC has been the standard term in Europe and technical industries, especially in applications like pipes, cables, and medical devices.
Vinyl has been more commonly used in North America, particularly for consumer and construction products such as flooring, wall coverings, and vinyl siding.
In recent years, "vinyl" has become more widely used globally. However, in technical, industrial, and regulatory contexts, "PVC" remains the standard term.
Is PVC toxic?
No. Polyvinyl chloride (PVC or vinyl) is an inert and non-toxic material that has been used safely for decades in various applications, including healthcare, construction, and consumer products.
Medical-grade vinyl meets strict regulatory standards and is widely used for blood bags, tubing, and other medical devices due to its safety, durability, and compatibility with sterilisation processes.
Additionally, vinyl products comply with stringent regulations such as the EU REACH framework, ensuring that only safe and approved additives are used.
At the end of its life, vinyl products can be recycled through mechanical, physical and chemical processes or safely incinerated in energy recovery facilities.
Why is vinyl used in medical applications?
Proven Performance in Healthcare
There are very specific reasons why certain plastics are used for specific medical applications. Vinyl (PVC) was first introduced in the 1950s, replacing fragile glass containers for blood storage. Since then, its unique properties have made it the material of choice for a wide range of medical devices and healthcare products.
More recently, vinyl demonstrated its value during the COVID-19 pandemic, being used in both traditional medical devices and innovative solutions. Its durability, weather resistance, and fire retardancy made it the ideal material for temporary testing and vaccination centers. Vinyl-based inflatable hoods for ventilators, gowns, gloves, and visors also played a key role in protecting healthcare workers.
Key Material Benefits
VersatilityVinyl’s versatility allows for the manufacturing of mono-material devices that combine both flexible and rigid parts. This simplifies production and enhances recyclability, which is already in place in many hospitals worldwide.
Strength & DurabilityVinyl retains flexibility, strength, and durability across a range of temperatures, including low-temperature environments where other materials may become brittle. For example, vinyl gloves provide strong protection against tearing, reducing the risk of contamination and offering a safe alternative to latex for allergy-prone users.
Biocompatibility & Chemical StabilityVinyl is highly biocompatible and hemocompatible, properties that can be further enhanced through surface modifications. It also maintains chemical stability, making it ideal for conveying a variety of medical liquids without leaching or degrading.
Resistance to Kinking & TransparencyVinyl medical tubing provides an optimal balance of transparency, flexibility, and anti-kinking properties. This makes it a preferred choice for IV lines, catheters, and respiratory tubing, where clear visibility and uninterrupted flow are essential.
Compatibility with SterilisationPlasticised, flexible vinyl medical devices can be easily sterilised using methods such as:
- Steam autoclave
- Radiation (electron beam or gamma rays)
- Ethylene oxide
Rigid, unplasticised vinyl medical devices can be sterilised using low-temperature steam (60 to 80°C), radiation, or ethylene oxide.
Welding & ProcessingVinyl is one of the few materials that can be welded using **high-frequency (HF) welding**, in addition to heated tool and vibration welding. This enables strong, durable bonds without the need for adhesives, making it ideal for the processing of collection bags, oxygen tents, and emergency and rescue equipment.
Cost EfficiencyVinyl offers unmatched cost-effectiveness. A shift to alternative materials could result in a price increase of 30%, making vinyl a financially sustainable choice for hospitals and healthcare providers.
How does the lifecycle of PVC compare to PVC-free alternatives?
There is a common assumption that PVC-free alternatives are more sustainable, but lifecycle data does not always support this claim. According to the European Chemicals Agency (ECHA), there is a lack of comprehensive life cycle assessment (LCA) data confirming that PVC-free alternatives perform better in terms of environmental impact.
Vinyl (PVC) products, including those used in healthcare, are generally easy to recycle mechanically and can also be processed through dissolution (physical recycling) or chemical recycling when needed. The European PVC industry is pioneering recycling schemes for medical devices VinylPlus® Med and pharmaceutical packaging VinylPlus® PharmPack. In contrast, many PVC-free alternatives lack comparable recycling pathways, often ending up in landfills or incineration or requiring more resource-intensive recycling technologies.
Additionally, PVC is one of the most resource-efficient plastics, made largely from alt (57%) and ethylene (43%), whereas many PVC-free alternatives are derived from ~100% fossil-based feedstocks. The long lifespan of PVC products, especially in hospital infrastructure, reduces the need for frequent replacement, further minimising environmental impact over time.
Without full LCA data on PVC-free alternatives, claims of superior sustainability remain unverified. As sustainability efforts evolve, expanding mechanical and chemical recycling for PVC remains a key strategy for improving circularity while ensuring product safety and performance.
References
European Chemicals Agency. (2023). Appendix C to the investigation report on PVC and PVC additives. European Chemicals Agency. https://echa.europa.eu/documents/10162/17233/rest_pvc_investigation_report_appendix_c_en.pdf
European Chemicals Agency. (2023). Investigation report on PVC and PVC additives. https://echa.europa.eu/documents/10162/17233/rest_pvc_investigation_report_en.pdf
Production
Is PVC resin production safe?
PVC resin is made by combining ethylene and hydrogen chloride or chlorine, to produce ethylene dichloride (EDC). EDC is then converted into vinyl chloride monomer (VCM). VCM is polymerised into PVC at high temperature and pressure. Both EDC and VCM are hazardous substances that require proper handling. The process of converting EDC and VCM into PVC takes place in a closed system, with no exposure to humans and the environment.
In Europe, strict regulations exist to protect workers and the environment. Additionally, the safe handling of EDC and VCM is part of the voluntary charter that European PVC raw material producers, members of ECVM (the European Council of Vinyl Manufacturers), have signed up to, and plants undergo regular third-party audits to verify compliance with legislative requirements.
Emissions limit values are set based on Best Available Techniques of the Industrial Emissions Directive. For these reasons, ECHA (the European Chemicals Agency) has concluded in its Investigation Report on PVC and PVC additives that “the operational conditions and risk management measures implemented in the VCM/PVC industry are adequate and effective to control the risk for workers from EDC and VCM,” and that “the levels of residual ECD/VCM in PVC articles seem to be appropriately controlled in Europe.”
Beyond EDC and VCM, the PVC industry also controls the emission of other chemicals: there are no relevant emissions of chloroform, hexachlorobutadiene, or PCBs from European VCM plants. VCM plants do not use or emit any CCl4. The emissions of dioxins and furans are regulated by the Industrial Emissions Directive, and dioxin/furans emission data are collected yearly by ECVM, showing a constant downward trend.
References
European Council of Vinyl Manufacturers. (2019, updated 2023). ECVM Industry Charter for the Production of Vinyl Chloride Monomer & PVC. https://pvc.org/sustainability/industry-responsible-care/ecvm-charter/
European Chemicals Agency. (2023). Investigation report on PVC and PVC additives. https://echa.europa.eu/documents/10162/17233/rest_pvc_investigation_report_en.pdf
How is VCM regulated in the production of PVC for healthcare applications?
Vinyl chloride monomer (VCM) is strictly regulated in Europe, ensuring its safe use in polyvinyl chloride (PVC or vinyl) used for healthcare applications.
VCM is a key raw material in the production of PVC resin, but it is completely consumed during polymerisation, meaning it is not present in any significant amounts in the final PVC products used in healthcare applications. European regulations, including REACH and the Industrial Emissions Directive, ensure strict controls on VCM handling, worker safety, and environmental emissions.
References
European Council of Vinyl Manufacturers. (2019, updated 2023). ECVM Industry Charter for the Production of Vinyl Chloride Monomer & PVC. https://pvc.org/sustainability/industry-responsible-care/ecvm-charter/
European Chemicals Agency. (2023). Investigation report on PVC and PVC additives. https://echa.europa.eu/documents/10162/17233/rest_pvc_investigation_report_en.pdf
Use
Do vinyl medical devices contain hazardous substances?
PVC or vinyl itself is an inert and non-toxic material, and all additives used in vinyl medical devices are strictly regulated under EU REACH, ensuring their safety. The principle of REACH is "no data, no market," meaning manufacturers must provide extensive safety data before substances can be used.
Some legacy plasticisers, such as low molecular weight (LMW) phthalates like DEHP, have been identified as harmful and have been phased out to nearly 100%. The European plasticiser industry has invested over €6 billion in developing safe alternatives like DINCH, DEHT, BTHC, and TOTM, which are not classified as Substances of Very High Concern (SVHC) and meet EU Medical Device Regulation (MDR) requirements. These alternatives have been thoroughly tested under REACH and are also approved for use in food contact materials.
The transition away from DEHP is already well underway, but certain critical applications, such as blood bags, still rely on DEHP due to its proven ability to extend blood shelf life. The industry is working closely with European blood banks to develop DEHP-free alternatives that do not compromise patient safety before the sunset date in 2030.
Additionally, biomonitoring studies on key plasticisers show that exposure levels across all sources remain safely within conservative limits. These safety thresholds are set with a significant margin of safety—often 100 times lower than the doses proven to have no effect in extensive animal studies—ensuring robust protection of human health.
Independent bodies such as EFSA, ANSES, and national environmental agencies in Denmark and Sweden have assessed and confirmed the safety of modern plasticisers. Manufacturers are required to update safety data regularly, ensuring that any new findings are incorporated into regulatory frameworks.
Overall, vinyl medical devices comply with the highest safety standards, and continuous innovation ensures that any potential risks are addressed while maintaining essential performance for healthcare applications.
References
Danish Environmental Protection Agency (2014). Alternatives to classified phthalates in medical devices. https://www2.mst.dk/Udgiv/publications/2014/03/978-87-93178-27-4.pdf
European Commission. (2023). Commission Regulation (EU) 2023/2482 of 13 November 2023 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards the substance bis(2-ethylhexyl) phthalate (DEHP) in medical devices. Official Journal of the European Union, L 2023/2482, 14 November 2023. http://data.europa.eu/eli/reg/2023/2482/oj
European Commission (2023). Commission Regulation (EU) 2023/1627 of 10 August 2023 amending Annex I to Regulation (EU) No 10/2011 as regards the authorisation of the substance bis(2-ethylhexyl)cyclohexane-1,4- dicarboxylate (FCM No 1079) (Text with EEA relevance). Official Journal of the European Union, L 201, 4-6. http://data.europa.eu/eli/reg/2023/1627/oj
European Directorate for the Quality of Medicines & HealthCare (EDQM). (2016). The European Pharmacopoeia revised its general chapters on plasticised PVC materials. https://www.edqm.eu/en/-/the-ph.-eur.-revised-its-general-chapters-on-plasticised-pvc-materials
European Plasticisers. (2016, March 18). No further regulatory risk management action needed for DEHTP and DINCH, ANSES confirms. https://www.plasticisers.org/news/no-further-regulatory-risk-management-action-needed-for-dehtp-and-dinch-anses-confirms/
Harmon, P., E Otter, R. (2022). A review of common non-ortho-phthalate plasticisers for use in food contact materials. Food and Chemical Toxicology, 164, 112984. https://doi.org/10.1016/j.fct.2022.112984
Kasper-Sonnenberg, M., Pälmke, C., Wrobel, S., Brüning, T., Murawski, A., Apel, P., Weber, T., Kolossa-Gehring, M., & Koch, H. M. (2024). Plasticizer exposure in Germany from 1988 to 2022: Human biomonitoring data of 20 plasticizers from the German Environmental Specimen Bank. Environment International, 109, 109190. https://doi.org/10.1016/j.envint.2024.109190
Swedish Chemicals Agency (2015). Phthalates which are toxic for reproduction and endocrine-disrupting – proposals for a phase-out in Sweden. https://www.kemi.se/download/18.6df1d3df171c243fb23a98ed/1591454109598/report-4-15-phatalates.pdf
Do vinyl medical devices leach hazardous substances to patients and healthcare workers?
No, vinyl medical devices do not pose a risk of hazardous substance leaching under normal use. Several factors ensure the safety of vinyl medical devices:
- Regulatory compliance: PVC, another word for vinyl, itself is inert and non-toxic, and medical-grade PVC meets strict EU safety regulations, including REACH and MDR.
- Minimal migration: Additives are firmly integrated into the vinyl matrix, significantly reducing the risk of leaching.
- Safer plasticisers: The substitutes for low molecular weight phthalates used today have very different molecular structures, leading to lower migration and a significantly reduced risk of adverse effects.
- Independent evaluations: Agencies such as EFSA, ECHA, and ANSES have assessed and confirmed the safety of modern plasticisers used in medical vinyl.
- Biomonitoring data: Studies on key plasticisers show that exposure levels across all sources remain well within conservative safety limits, which are often set 100 times lower than doses proven to have no effect in extensive animal studies.
- Proven safety in healthcare: Vinyl medical devices have been used in critical applications like blood bags, IV tubing, and respiratory equipment for decades, with long-term monitoring demonstrating their reliability.
Through strict regulatory oversight, advanced material formulations, and real-world data, vinyl medical devices remain a safe and trusted choice for healthcare applications.
References
Danish Environmental Protection Agency (2014). Alternatives to classified phthalates in medical devices. https://www2.mst.dk/Udgiv/publications/2014/03/978-87-93178-27-4.pdf
European Commission. (2023). Commission Regulation (EU) 2023/2482 of 13 November 2023 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards the substance bis(2-ethylhexyl) phthalate (DEHP) in medical devices. Official Journal of the European Union, L 2023/2482, 14 November 2023. http://data.europa.eu/eli/reg/2023/2482/oj
European Commission (2023). Commission Regulation (EU) 2023/1627 of 10 August 2023 amending Annex I to Regulation (EU) No 10/2011 as regards the authorisation of the substance bis(2-ethylhexyl)cyclohexane-1,4- dicarboxylate (FCM No 1079) (Text with EEA relevance). Official Journal of the European Union, L 201, 4-6. http://data.europa.eu/eli/reg/2023/1627/oj
European Directorate for the Quality of Medicines & HealthCare (EDQM). (2016). The European Pharmacopoeia revised its general chapters on plasticised PVC materials. https://www.edqm.eu/en/-/the-ph.-eur.-revised-its-general-chapters-on-plasticised-pvc-materials
European Plasticisers. (2016, March 18). No further regulatory risk management action needed for DEHTP and DINCH, ANSES confirms. https://www.plasticisers.org/news/no-further-regulatory-risk-management-action-needed-for-dehtp-and-dinch-anses-confirms/
Harmon, P., E Otter, R. (2022). A review of common non-ortho-phthalate plasticisers for use in food contact materials. Food and Chemical Toxicology, 164, 112984. https://doi.org/10.1016/j.fct.2022.112984
Kasper-Sonnenberg, M., Pälmke, C., Wrobel, S., Brüning, T., Murawski, A., Apel, P., Weber, T., Kolossa-Gehring, M., & Koch, H. M. (2024). Plasticizer exposure in Germany from 1988 to 2022: Human biomonitoring data of 20 plasticizers from the German Environmental Specimen Bank. Environment International, 109, 109190. https://doi.org/10.1016/j.envint.2024.109190
Swedish Chemicals Agency (2015). Phthalates which are toxic for reproduction and endocrine-disrupting – proposals for a phase-out in Sweden. https://www.kemi.se/download/18.6df1d3df171c243fb23a98ed/1591454109598/report-4-15-phatalates.pdf
Can DEHP be substituted in all medical devices?
The substituion of DEHP with safe alternatives has already been successfully implemented in nearly all medical applications. However, blood bags remain a challenge. Since the 1950s, PVC (vinyl) plasticised with DEHP has been the only material proven to preserve blood for up to 49 days, ensuring availability for patients with rare blood types, which are often found among minority groups.
The industry is working closely with European blood banks to develop DEHP-free blood bags that maintain blood quality and safety without compromising supply, ahead of the 2030 sunset date for DEHP in medical devices.
References
American National Red Cross. (n.d.). Diversity in blood types. https://www.redcrossblood.org/donate-blood/blood- types/diversity.html
European Commission. (2023). Commission Regulation (EU) 2023/2482 of 13 November 2023 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards the substance bis(2-ethylhexyl) phthalate (DEHP) in medical devices. Official Journal of the European Union, L 2023/2482, 14 November 2023. http://data.europa.eu/eli/reg/2023/2482/oj
ISBT Regional Congress. (2023). Abstracts of the 33rd Regional Congress of the ISBT, Gothenburg, Sweden, 17-21 June 2023, Vox Sanguinis, 118(S1), 6-118. https://doi.org/10.1111/vox.13433
VCM is a key raw material in the production of PVC resin, but it is completely consumed during polymerisation, meaning it is not present in any significant amounts in the final PVC products used in healthcare applications. European regulations, including REACH and the Industrial Emissions Directive, ensure strict controls on VCM handling, worker safety, and environmental emissions.
References
European Council of Vinyl Manufacturers. (2019, updated 2023). ECVM Industry Charter for the Production of Vinyl Chloride Monomer & PVC. https://pvc.org/sustainability/industry-responsible-care/ecvm-charter/
European Chemicals Agency. (2023). Investigation report on PVC and PVC additives. https://echa.europa.eu/documents/10162/17233/rest_pvc_investigation_report_en.pdf
Why is DEHP still used in blood bags?
DEHP continues to be used in blood bags for several reasons, which are closely tied to recent regulatory developments, patient safety considerations, and the challenges faced by the industry in transitioning to alternatives:
- Regulatory Extension for DEHP Use: The European Commission's amendment (EU 2023/2482) to the REACH regulation (EC No 1907/2006) extends the sunset date for the use of DEHP in medical devices to July 1, 2030. This aligns with the transitional periods specified in the Medical Device Regulation (MDR), providing additional time for the industry to adapt to DEHP-free alternatives. The original sunset date for DEHP under REACH was set for May 2025.
- Patient Safety and Validation: Ensuring patient safety is paramount. The transition to DEHP-free blood bags requires comprehensive evaluations and validation processes. The alignment of the DEHP sunset date with the MDR transitional period allows for thorough testing and validation of approximately 18 million blood bag sets annually. This is crucial to ensure patient safety during the transition to non-DEHP materials.
- Challenges in Transitioning to DEHP-Free Alternatives: Despite the existence of promising alternatives like DEHT, BTHC, and DINCH, the industry faces significant challenges in moving away from DEHP:
- Reclassification Under MDR: Blood bag sets containing anticoagulant solutions are being reclassified from class IIb to class III, indicating a stricter regulatory classification.
- Complex Regulatory Environment: Navigating the landscape shaped by various directives, regulations, and the recent amendment adds complexity to the transition.
- National Validation of Non-DEHP Sets: Each non-DEHP blood bag set requires national validation, a process that can be time-consuming and resource-intensive.
- Operational and Manufacturing Challenges: The COVID-19 pandemic has exacerbated operational difficulties, and there are complexities in manufacturing both DEHP and non-DEHP products. Ensuring a stable supply of blood bags during this transition is critical to avoid potential shortages.
- Ensuring Comprehensive Validation: The extended timeline ensures that all non-DEHP blood products undergo the required validations at both national and local levels. This step is essential for maintaining the safety and efficacy of these medical devices.
In summary, the continued use of DEHP in blood bags is influenced by the need to ensure patient safety, comply with regulatory requirements, address the challenges in transitioning to DEHP-free alternatives, and manage operational and manufacturing complexities. The industry, with VinylPlus Healthcare partner RENOLIT Healthcare in a leading role, is actively working towards adopting safer alternatives, but this transition must be carefully managed to maintain the high standards of safety and efficacy required for medical devices.
References
Chartois, A., Aoustin, L., Rivery, E., Colombat, M., Acquart, S., & Bigey, F. (2023). In vitro evaluation of red cell concentrates and plasma prepared and stored in non-DEHP bags from whole blood collected in full non-DEHP in-line system. Vox Sanguinis, Volume 118(Issue S1), 6-118. https://doi.org/10.1111/vox.13433
European Commission. (2023). Commission Regulation (EU) 2023/2482 of 13 November 2023 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards the substance bis(2-ethylhexyl) phthalate (DEHP) in medical devices. Official Journal of the European Union, L 2023/2482, 14 November 2023. http://data.europa.eu/eli/reg/2023/2482/oj
European Parliament and Council of the European Union. (2023). Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. Official Journal of the European Union. http://data.europa.eu/eli/reg/2023/607/oj
L Lasocka, J., Goczynska, P., Potocka, E., Rosiek, A., & Lachert, E. (June 2023). Evaluation of containers with innovative PVC plasticizer used for 42-day storage of BCR-AS. Vox Sanguinis, Volume 118 (Issue S1), 6-118. https://doi.org/10.1111/vox.13433
Lagerberg, J., Go, M., Vlaar, R., Klei, T. (June 2023). Comparison of the in vitro quality of red cell concentrates, prepared from whole blood collected in DINCH-PVC and stored in BTHC-, DEHT- and DINCH-PVC storage bags. Vox Sanguinis, Volume 118(Issue S1), 6-118. https://doi.org/10.1111/vox.13433
How far is the development of non-DEHP PVC blood bags?
Historically, the use of DEHP as a plasticiser in PVC blood collection systems, including bags and tubing, has been integral for maintaining the stability and integrity of red blood cells (RBCs), which is crucial for effective blood transfusions. The updated EU Medical Device Regulation and the REACH regulation now mandate the phase-out of DEHP from blood bags before 1 July 2030.
RENOLIT Healthcare, a VinylPlus® Healthcare partner and leading film producer for blood bags and other medical applications, is at the forefront of this transition. Early test results of blood bags using a prototype non-phthalate PVC film, called RENOLIT Bloodprotect 42Plus, show RBC haemolysis level (0.17 ± 0.1 %) with no significant difference to DEHP (0.16 ± 0.2 %) after 42 days of storage, when using conventional SAG-M storage solution, thereby exceeding the performance of the current DEHP replacements DINCH, DEHT, and BTHC.
By changing to PAGGS-M solution, Dutch national blood organisation Sanquin has found hemolysis rates comparable to DEHP for red blood concentrate (RCC) collected in DINCH plasticised collection bags and stored for 42 days in blood bags plasticised with DINCH, DEHT, or BTHC. The French Blood Establishment (EFS) has found that RCCs stored in a PVC/Citrate/PAGGS-M storage bag for 49 days were compliant with French quality requirements, as were plasma prepared and stored in a DINCH plasticised PVC container.
It will be a long-term endeavour to turn the RENOLIT prototype or other solutions to reality. Nonetheless, a game-changing DEHP-free blood bag is on the horizon.
References
Chartois, A., Aoustin, L., Rivery, E., Colombat, M., Acquart, S., & Bigey, F. (2023). In vitro evaluation of red cell concentrates and plasma prepared and stored in non-DEHP bags from whole blood collected in full non-DEHP in-line system. Vox Sanguinis, Volume 118(Issue S1), 6-118. https://doi.org/10.1111/vox.13433
European Commission. (2023). Commission Regulation (EU) 2023/2482 of 13 November 2023 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards the substance bis(2-ethylhexyl) phthalate (DEHP) in medical devices. Official Journal of the European Union, L 2023/2482, 14 November 2023. http://data.europa.eu/eli/reg/2023/2482/oj
European Parliament and Council of the European Union. (2023). Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. Official Journal of the European Union. http://data.europa.eu/eli/reg/2023/607/oj
L Lasocka, J., Goczynska, P., Potocka, E., Rosiek, A., & Lachert, E. (June 2023). Evaluation of containers with innovative PVC plasticizer used for 42-day storage of BCR-AS. Vox Sanguinis, Volume 118 (Issue S1), 6-118. https://doi.org/10.1111/vox.13433
Lagerberg, J., Go, M., Vlaar, R., Klei, T. (June 2023). Comparison of the in vitro quality of red cell concentrates, prepared from whole blood collected in DINCH-PVC and stored in BTHC-, DEHT- and DINCH-PVC storage bags. Vox Sanguinis, Volume 118(Issue S1), 6-118. https://doi.org/10.1111/vox.13433
Are PVC-free blood bags available on the market, or will they be soon?
The PVC-Free Blood Bag Project (2011-2018), a part of the EU’s Life+ Environmental Programme, aimed to produce a PVC-free blood bag that met the required specifications, including CE labeling. This aim was not achieved: Gulliksson et al. (2016) found that the novel polyolefin blood storage bag failed to maintain acceptable hemolysis levels within the conventional 42-day storage period.
Since the conclusion of the project in 2018, there has been a notable lack of progression towards a market-ready PVC-free blood bag. This stagnation can be attributed to the absence of continued interest or involvement from commercial partners, blood banks, and other stakeholders in further developing or commercialising the technology.
References
Gulliksson, H., Meinke, S., Ravizza, A., Larsson, L., & Höglund, P. (2016). Storage of red blood cells in a novel polyolefin blood container: A pilot in vitro study. Vox Sanguinis. https://doi.org/10.1111/vox.12472
DEHP-free plasticisers for medical devices have been developed. But aren’t all plasticisers alike?
A common concern with plasticisers is their potential to migrate, leach, or evaporate, as they are physically blended into the PVC (vinyl) matrix rather than chemically bound. However, not all plasticisers behave the same way.
The observed adverse effects of DEHP and other low molecular weight (LMW) phthalates result from their specific molecular structures, which lead to higher migration rates. In contrast, medically approved DEHP-free plasticisers such as DINCH, DEHT, BTHC, and TOTM are significantly more stable, migrating far less and staying firmly embedded within the material under normal conditions.
Biomonitoring studies on key DEHP substitutes show that exposure levels across all sources remain safely within conservative limits. These safety thresholds are set with a significant margin of safety—often 100 times lower than the doses proven to have no effect in extensive animal studies—ensuring robust protection of human health.
References
Kasper-Sonnenberg, M., Pälmke, C., Wrobel, S., Brüning, T., Murawski, A., Apel, P., Weber, T., Kolossa-Gehring, M., & Koch, H. M. (2024). Plasticizer exposure in Germany from 1988 to 2022: Human biomonitoring data of 20 plasticizers from the German Environmental Specimen Bank. Environment International, 109, 109190. https://doi.org/10.1016/j.envint.2024.109190
What has the industry done to prove the safety of the DEHP substitutes before introducing them on the market?
The producers have thoroughly tested alternative plasticisers, with development beginning years before the implementation of REACH. Under the EU chemicals regulation REACH—considered the strictest in the world—industry must demonstrate the safety of any substance before it can be used on the market. REACH requires chemical manufacturers to register substances with the European Chemicals Agency, providing comprehensive safety data.
For medical devices, which are specifically regulated under the Medical Device Regulation (MDR), manufacturers must conduct a benefit-risk analysis for each intended application. Safe use assessments for medical devices include extensive testing covering acute toxicity, skin and eye irritation, sensitisation, repeat-dose toxicity, genotoxicity, carcinogenicity, reproductive and developmental toxicity, and endocrine disruption.
Since many plasticisers have dual-use applications, their full environmental impact is also assessed under REACH requirements, ensuring a high level of protection for both human health and the environment.
References
European Parliament and Council of the European Union. (2017). Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Official Journal of the European Union. Retrieved from http://data.europa.eu/eli/reg/2017/745/2025-01-10
European Chemicals Agency. (n.d.). ECHA CHEM. https://chem.echa.europa.eu/
European Chemicals Agency. (n.d.). Registered substances. https://echa.europa.eu/information-on-chemicals/registered-substances
We don’t know the long-term consequences of the DEHP substitutes. Shouldn’t we use the precautionary principle and avoid using the substances, in particular in medical devices that are used on newborns or other vulnerable humans?
The four plasticisers used in medical devices as listed in the European Pharmacopoeia (DINCH, BTHC, TOTM, and DEHT) have been used for more than 20 years. No adverse effects have been observed. In addition to the studies undertaken to satisfy the REACH information requirements, DINCH, BTHC, and DOTP have been subject to repeat dose toxicity testing on the intravenous route – for a time period that is sufficient to do a safety assessment for medical applications.
Furthermore, REACH obliges registrants to update the dossiers if new evidence of environmental and health effects becomes available. ECHA can also review any dossier at any time to check if the information is correct.
Additionally, under the EU Medical Device Regulation (MDR), all plasticisers used in medical devices must undergo rigorous safety and benefit-risk assessments to ensure they meet stringent patient safety requirements.
References
European Chemicals Agency. (n.d.). ECHA CHEM. https://chem.echa.europa.eu/
European Chemicals Agency. (n.d.). Registered substances. https://echa.europa.eu/information-on-chemicals/registered-substances
European Chemicals Agency. (n.d.). Understanding REACH. https://echa.europa.eu/da/regulations/reach/understanding-reach
European Directorate for the Quality of Medicines & HealthCare (EDQM). (2016). The European Pharmacopoeia revised its general chapters on plasticised PVC materials. https://www.edqm.eu/en/-/the-ph.-eur.-revised-its-general-chapters-on-plasticised-pvc-materials
European Parliament and Council of the European Union. (2017). Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Official Journal of the European Union. http://data.europa.eu/eli/reg/2017/745/2025-01-10
Are there any third-party bodies such as government agencies that have assessed the safety of the DEHP substitutes?
- The substitutes are not classified as hazardous according to the CLP Regulation
- DINCH and DEHT were subject to PACT and REACH compliance checks by ECHA. For some other substances minor formal requirements need to be completed to comply with increase production volumes under REACH
- Listed for medical applications by the European Pharmacopoeia
- Meet requirements of the EU Medical Device Regulation
- Evaluated by the European Food Safety Authority (EFSA)
- Evaluated by the French Agency for Food, Environmental and Occupational Health & Safety (ANSES)
- Evaluated by the Danish Environmental Protection Agency
- Evaluated by the Swedish Chemicals Agency
- Evaluated by the European Commission’s Scientific Committee on Emerging and Newly-Identified Health Risks (SCENIHR)
- Toxicity Reviews by the US Consumer Product Safety Commission
- Assessment by the Australian Inventory of Chemical Substances (AICS)
- Peer-reviewed publications by the US NSF (health advisory board chaired by the US EPA)
How does the European Pharmacopoeia ensure impartiality in the inclusion of plasticisers and other substances?
Concerns regarding the European Pharmacopoeia's decision-making process are understandable, given its significant role in establishing standards for medicines. The European Directorate for the Quality of Medicines & Healthcare (EDQM) oversees the European Pharmacopoeia. The EDQM is a directorate of the Council of Europe, an organisation distinct from the European Union, dedicated to upholding human rights, democracy, and the rule of law. Here's how the EDQM ensures impartiality in its decision-making process:
Transparent and Rigorous Process: The procedure for adding substances to the European Pharmacopoeia is designed to be both transparent and based on scientific evidence. Each proposed addition undergoes a thorough review to ensure its safety, quality, and efficacy.
Public Consultation: Before a substance is added, its draft monograph is published in "Pharmeuropa" for public consultation. This allows stakeholders from various sectors, including NGOs, industry representatives, healthcare professionals, and the general public, to provide feedback, ensuring a broad range of perspectives are considered.
Expert Groups: The expert groups, which draft and review the monographs, are primarily composed of experts nominated by member states. These experts are selected based on their knowledge and experience, and they operate with a commitment to public health. While they may consult with industry representatives for specific technical insights, the final decision-making power rests with the experts.
Conflict of Interest Policies: All members involved in the decision-making process, including those in expert groups, are required to declare any potential conflicts of interest. This ensures that decisions are made without any undue influence from external parties.
Regular Reviews: Even after a substance is added, its monograph is subject to regular reviews to ensure it remains up-to-date with the latest scientific knowledge. If new evidence emerges about a substance's safety or efficacy, the monograph can be revised or withdrawn.
In summary, the EDQM, under the auspices of the Council of Europe, has robust mechanisms in place to ensure that the addition of substances to the European Pharmacopoeia is impartial and based on sound scientific principles. The primary commitment is always to the safety and well-being of patients. For more information, you can visit the official EDQM website at edqm.eu.
Isn’t it better to replace vinyl altogether to avoid plasticisers?
Plasticisers are among the most extensively researched substances. While some low molecular weight (LMW) phthalates have been linked to adverse health and environmental effects, others have not. In response, the chemical industry has developed safe alternatives with well-documented toxicological profiles. These alternative plasticisers have now replaced LMW phthalates in Europe by nearly 100%.
Some advocate phasing out PVC (vinyl) in favour of materials that do not require plasticisers. However, avoiding plasticisers does not necessarily mean avoiding additives altogether. Plastics rely on a number of chemicals in their production processes. Some alternatives to PVC also contain additives or manufacturing residues, some of which may migrate from products and pose potential health risks, depending on the substance and level of exposure.
A 2022 study prepared for the European Commission’s Directorate-General for Environment (DG ENV) explicitly identifies the risk of regrettable substitution, where replacing PVC with other materials may introduce new health or environmental concerns. The European Chemicals Agency (ECHA) has also highlighted gaps in the assessment of alternative plastics and their additives, noting that no quantitative comparison of health and environmental risks between PVC and alternative materials was available.
A recent example is the phthalate DIBP, classified as toxic to reproduction, which has been found to migrate at trace levels from polypropylene (PP) and polyethylene (PE) drinking bottles following repeated dishwashing. One possible source is residues from catalyst systems used during production.
As a result, replacing vinyl with other plastics does not automatically guarantee safer outcomes. Material choices should be based on scientific evidence, considering chemical composition, potential exposure and the overall health and environmental impacts of the alternatives.
References
European Chemicals Agency. (2023). Investigation report on PVC and PVC additives. https://echa.europa.eu/documents/10162/17233/rest_pvc_investigation_report_en.pdf
European Chemicals Agency. (2023). Appendix C to the investigation report on PVC and PVC additives. https://echa.europa.eu/documents/10162/17233/rest_pvc_investigation_report_appendix_c_en.pdf
European Commission, Directorate-General for Environment, (2022). The use of PVC (poly vinyl chloride) in the context of a non-toxic environment: final report, Publications Office of the European Union. https://data.europa.eu/doi/10.2779/375357
Wiesinger, H., Wang, Z., & Hellweg, S. (2021). Deep dive into plastic monomers, additives, and processing aids. Environmental Science & Technology, 55(13), 9339–9351. https://doi.org/10.1021/acs.est.1c00976
Cuthbertson, A. A., et al. (2024). Characterization of polymer properties and identification of additives in commercially available research plastics. Green Chemistry, 26, 7067–7090. https://doi.org/10.1039/d4gc00659c
Tian, L., Skoczynska, E., den Boer, A., & Bayen, S. (2025). Impact of dishwashing on the chemical mixtures leaching from reusable plastic bottles. Journal of Food Composition and Analysis, 148, 108371. https://doi.org/10.1016/j.jfca.2025.108371
Are PVC-free medical devices safer for patients and health workers?
The claim that PVC-free or halogen-free materials represent a more precautionary approach in healthcare overlooks the progress and advantages associated with modern polyvinyl chloride (PVC or vinyl) medical devices.
Over the past decades, the vinyl industry has undergone a significant transformation, addressing concerns about production, additives, and end-of-life management.
According to the European Chemicals Agency (ECHA), risks from PVC resin production are appropriately managed. The agency also finds that modern municipal waste incineration plants can process PVC waste as safely as other common waste types, without issues related to dioxins or acid gases. Pilot projects further demonstrate the safe recycling of PVC medical devices into durable healthcare applications such as wall coverings.
DEHP-free PVC solutions are now widely available, meeting stringent safety and quality standards for healthcare applications.
PVC stands out for its unique combination of flexibility, durability, and adaptability, making it ideal for critical medical applications such as IV bags, tubing, and containers. These characteristics are difficult to replicate in alternative materials without introducing new technical or safety issues. Hospitals and healthcare providers have reported performance challenges with some alternatives, such as problems with shape retention and durability during freezing and thawing cycles, which are essential for certain medical procedures.
Furthermore, transitioning away from PVC entirely can result in supply chain disruptions, validation challenges, significant cost increases in medical devices, and a potential reduction in access to essential healthcare products. For instance, PVC remains the only material approved for use in blood bags due to its unique properties, enabling the separation of blood components essential for life-saving treatments and medications. Additionally, PVC allows red blood cells to be stored for up to 49 days, a critical advantage for blood banks that rely on extended storage, particularly for rare blood types often found among minority populations.
Studies have also highlighted the risk of regrettable substitution when alternatives introduce their own health or environmental risks, requiring careful evaluation. For example, the classified phthalate DIBP has been found to migrate from polypropylene (PP) and polyethylene (PE) products, possibly originating from catalyst mixtures used in their production.
References
American National Red Cross. (n.d.). Diversity in blood types. https://www.redcrossblood.org/donate-blood/blood-types/diversity.html
European Chemicals Agency. (2023). Investigation report on PVC and PVC additives. https://echa.europa.eu/documents/10162/17233/rest_pvc_investigation_report_en.pdf
European Commission, Directorate-General for Environment, (2022). The use of PVC (poly vinyl chloride) in the context of a non-toxic environment: final report, Publications Office of the European Union. https://data.europa.eu/doi/10.2779/375357
Wiesinger, H., Wang, Z., & Hellweg, S. (2021). Deep dive into plastic monomers, additives, and processing aids. Environmental Science & Technology, 55(13), 9339–9351. https://doi.org/10.1021/acs.est.1c00976
Cuthbertson, A. A., et al. (2024). Characterization of polymer properties and identification of additives in commercially available research plastics. Green Chemistry, 26, 7067–7090. https://doi.org/10.1039/d4gc00659c
Tian, L., Skoczynska, E., den Boer, A., & Bayen, S. (2025). Impact of dishwashing on the chemical mixtures leaching from reusable plastic bottles. Journal of Food Composition and Analysis, 148, 108371. https://doi.org/10.1016/j.jfca.2025.108371
Are cables, flooring, and other vinyl-based products safe for healthcare environments?
Yes, PVC or vinyl products used in healthcare settings meet strict safety regulations. Fire safety is a key benefit – PVC is naturally self-extinguishing and does not contribute to flame spread, making it a reliable choice for hospital infrastructure such as flooring and wall covering, medical cables, and power cords. Additionally, modern PVC formulations for cables and other products are designed to minimise smoke and acidity in fires, reducing potential corrosive effects on equipment and infrastructure.
Further, vinyl indoor products comply with the EU Construction Products Regulation (CPR), which sets strict requirements for emissions of toxic gases, volatile organic compounds (VOCs), and hazardous particles.
As an example, the release of VOCs from vinyl is often lower than from other materials. Vinyl flooring can achieve classifications such as M1 and Emission dans l'air intérieur, which are only given to products that guarantee a good indoor climate. Off-gassing from vinyl flooring is below 10 μg/m³ after 28 days, and many vinyl floors are even below the detection limit. In comparison, emissions from lacquered floors and linoleum are 25 μg/m³ and 100 μg/m³, respectively. It is also well known that formaldehyde can off-gas from the glue in laminate flooring, just as it is naturally occurring in wood.
References
Babrauskas, V. (1992). Heat release rate: The single most important variable in fire hazard. Fire Safety Journal, 18(3), 255–272. https://doi.org/10.1016/0379-7112(92)90019-9
Cardelli, C. (2023). FRLS PVC compounds and their role in reducing smoke and toxicity.
Cardelli, C. (2024). PVC cables standards in Europe and beyond. PVC4Cables Conference 2024, Prague. https://pvc4cables.org/wp-content/uploads/2024/12/cardelli_standards_2024.pdf
Delchiaro, et al. (2024). Toxicity of PVC cable compounds during combustion compared to halogen-free alternatives. PVC4Cables Conference 2024, Prague. https://pvc4cables.org/wp-content/uploads/2024/12/sarti_2024.pdf
European Parliament and Council of the European Union. (2011). Regulation (EU) No 305/2011 of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC (Text with EEA relevance). EUR-Lex. https://data.europa.eu/eli/reg/2011/305/oj
Godt Arbejdsmiljø (2024). Gulvtyper – fordele og ulemper. https://www.godtarbejdsmiljo.dk/stoej-lys-luft/raadgivere/krav_til_materialer/gulvtyper-_-fordele-og-ulemper
Hirschler, M. (2006). Acidity is a poor representation of smoke corrosivity and is totally inadequate as a representation of smoke toxicity. https://citeseerx.ist.psu.edu/document?repid=rep1&type=pdf&doi=8a3c0b2110638d8bb351105ca451efaf22f10031
Hirschler, M. (2006). Fire safety, smoke toxicity and acidity. https://citeseerx.ist.psu.edu/document?repid=rep1&type=pdf&doi=8a3c0b2110638d8bb351105ca451efaf22f10031
Circularity & End-of-Life
Is it safe to incinerate medical PVC waste?
Incineration of vinyl or PVC in modern incineration plants is safe and well-regulated, ensuring the effective destruction of contaminants. In many cases, the thermal energy produced from incineration is recovered for electricity and district heating.
Advanced flue gas cleaning technologies neutralise emissions such as hydrochloric acid (HCl), keeping them within strict EU environmental standards.
Studies confirm that removing PVC from the waste stream does not eliminate dioxin formation, as combustion conditions play the most significant role.
According to the European Chemicals Agency, European incinerators can safely handle waste containing up to 2% PVC without smoke cleaning or corrosion issues.
References
European Chemicals Agency. (2023). Investigation report on PVC and PVC additives. https://echa.europa.eu/documents/10162/17233/rest_pvc_investigation_report_en.pdf. p. 12
Swedish Environmental Protection Agency (1999). Life cycles assessments and solid waste - Guidelines for solid waste treatment and disposal in LCA (AFR-REPORT 279). AFN, Swedish Environmental Protection Agency. https://p2infohouse.org/ref/37/36473.pdf
Themelis, N. J. (2010). Chlorine sources, sinks, and impacts in WTE power plants. Proceedings of the 18th Annual North American Waste-to-Energy Conference, Paper No: NAWTEC18-3577, pp. 77-84. https://doi.org/10.1115/NAWTEC18-3577
Are dioxins and acid gases released when incinerating medical PVC waste?
Incineration of vinyl or PVC in modern incineration plants is safe and well-regulated, ensuring the effective destruction of contaminants. In many cases, the thermal energy produced from incineration is recovered for electricity and district heating.
Advanced flue gas cleaning technologies neutralise emissions such as hydrochloric acid (HCl), keeping them within strict EU environmental standards.
Studies confirm that removing PVC from the waste stream does not eliminate dioxin formation, as combustion conditions play the most significant role.
According to the European Chemicals Agency, European incinerators can safely handle waste containing up to 2% PVC without smoke cleaning or corrosion issues.
References
European Chemicals Agency. (2023). Appendices A and B to the investigation report on PVC and PVC additives. https://echa.europa.eu/documents/10162/17233/rest_pvc_investigation_report_appendix_a_b_en.pdf. p. 7
Swedish Environmental Protection Agency. (1999). Life cycle assessments and solid waste - Guidelines for solid waste treatment and disposal in LCA (AFR-REPORT 279). AFN, Swedish Environmental Protection Agency. https://p2infohouse.org/ref/37/36473.pdf
Themelis, N. J. (2010). Chlorine sources, sinks, and impacts in WTE power plants. Proceedings of the 18th Annual North American Waste-to-Energy Conference, Paper No: NAWTEC18-3577, pp. 77-84. https://doi.org/10.1115/NAWTEC18-3577
Can PVC products used in hospitals be recycled?
Yes, both flexible and rigid PVC/vinyl products can be recycled mechanically several times without significant loss of technical properties.
Single-use medical devices made of non-contaminated PVC (vinyl) can be collected and recycled through initiatives such as those run by VinylPlus Healthcare, which transform discarded PVC medical products into new, high-quality applications for the healthcare sector. The VinylPlus® PharmPack project aims to enhance the circularity of rigid PVC films used in pharmaceutical packaging by improving recycling pathways.
Beyond medical devices, much of hospital infrastructure, including pipes, windows, flooring, and even emergency structures, is made from durable PVC. These products have been successfully recycled through VinylPlus® since 2000, contributing to a well-established circular economy for PVC.
Can PVC pharmaceutical blister packaging be recycled?
Yes. Mechanical recycling of pre-consumer PVC blister packaging waste is already well-established in Europe.
The VinylPlus® PharmPack project aims to enhance the circularity of rigid PVC films used in pharmaceutical packaging by improving recycling pathways. This involves collecting post-consumer waste for established mechanical recycling and demonstrating that high-quality recyclate can be recovered from advanced physical recycling technologies that can be used for new PVC films.
How does the EU Packaging and Packaging Waste Regulation apply to pharmaceutical blister packaging?
Pharmaceutical packaging is not entirely exempt from the EU Packaging and Packaging Waste Regulation (PPWR), but important exemptions recognise its specific safety and quality requirements.
Immediate pharmaceutical packaging, including blister packs in direct contact with medicines, is exempt from the PPWR’s recyclability requirements. It is also exempt from the minimum recycled-content requirements applying to plastic packaging. Certain outer pharmaceutical packaging is exempt as well where this is necessary to preserve the quality of the medicinal product. Similar exemptions apply to contact-sensitive packaging for medical devices and in-vitro diagnostic medical devices.
These exemptions recognise that patient safety and the quality and performance of medicines and medical devices must remain paramount. They do not prevent the development of voluntary recycling solutions. Through VinylPlus® PharmPack, the European PVC value chain is developing mechanical and dissolution-based recycling routes for PVC pharmaceutical blister packaging.
The European Commission is required to review the recyclability exemptions by 1 January 2035, taking account of developments in sorting and recycling technologies and practical experience.
Is PVC compatible with chemical recycling?
Yes. One option is pyrolysis, where multiple companies are actively developing processes to include PVC (vinyl) in mixed plastic waste streams, typically ranging from 3% to 10% PVC.
A VinylPlus-led project demonstrated that a waste stream containing 10% PVC can successfully yield pyrolysis oil suitable for use in a steam cracker, ultimately serving as feedstock for new plastics. This confirms that PVC/vinyl can be processed through chemical recycling alongside other plastics, supporting circular economy goals.
References
VinylPlus. (2026). Advanced Recycling. https://www.vinylplus.eu/commitment-in-action/innovation/advanced-recycling/
Is it safe to recycle plastic waste, including used medical devices, from healthcare settings?
Yes. Recycling plastic waste from healthcare settings is safe when strict hygiene protocols are followed. VinylPlus Healthcare's recycling activities focus on collecting clean, non-contaminated vinyl waste, operating under strict guidelines similar to deposit return schemes for bottles.
The risk of contamination is minimal because the collected devices:
- Have not been in contact with infectious materials
- Are used in controlled medical environments, such as elective surgeries
Clear hospital guidelines, posters, and intensive staff training ensure that only approved vinyl medical waste is placed in dedicated bins. Strict hygiene procedures protect hospital staff, waste handlers, and recyclers, ensuring safety throughout the process.
Are PVC-free alternatives safer from a waste management perspective?
There is a perception that so-called PVC-free alternatives are inherently safer for waste management. However, other plastics such as polyethylene (PE), polypropylene (PP), polyurethane (PU or PUR), polystyrene (PS), polyethylene terephthalate (PET), low-density polyethylene (LDPE), and high-density polyethylene (HDPE) each present significant environmental and health challenges.
Research indicates that burning PE, PP, PS, PET, and HDPE at low temperatures or under open-fire conditions releases volatile organic compounds (VOCs), aldehydes, polycyclic aromatic hydrocarbons (PAHs), and persistent free radicals, some of which are carcinogenic or toxic. Additionally, PU alternatives may emit highly toxic substances such as isocyanates when incinerated under controlled conditions. When burned openly or at low temperatures, PU can release other extremely hazardous gases, including hydrogen cyanide and phosgene.
Replacing vinyl with other plastics does not eliminate environmental concerns and may introduce new challenges for health and environment. According to the ECHA and the European Commission’s Directorate-General for Environment (DG-ENV), some PVC-free alternatives have technical drawbacks that could compromise patient safety, while their life cycle impacts remain largely unknown. With increasing scrutiny on chemicals in all plastics, material safety should be assessed based on scientific evidence rather than assumptions, ensuring patient safety and performance remain the top priorities.
Instead of calling for PVC-free alternatives, efforts should support and expand initiatives already led by VinylPlus, focused on increased collection, novel sorting technologies, and advancements in recycling to further enhance the sustainability of medical vinyl. Physical recycling methods like dissolution can recover high-quality vinyl from complex waste streams, while chemical recycling techniques, including pyrolysis, hold potential for converting vinyl waste into valuable raw materials, even when mixed with other plastics.
References
European Chemicals Agency. (2023). Appendix C to the investigation report on PVC and PVC additives. European Chemicals Agency. https://echa.europa.eu/documents/10162/17233/rest_pvc_investigation_report_appendix_c_en.pdf
European Commission, Directorate-General for Environment, (2022). The use of PVC (poly vinyl chloride) in the context of a non-toxic environment: final report, Publications Office of the European Union. https://data.europa.eu/doi/10.2779/375357
Pathak, G., Nichter, M., Hardon, A., Moyer, E., Latkar, A., Simbaya, J., Pakasi, D., Taqueban, E., & Love, J. (2023). Plastic pollution and the open burning of plastic wastes. Global Environmental Change, 80, 102648. https://doi.org/10.1016/j.gloenvcha.2023.102648
Valavanidis, A., Iliopoulos, N., Gotsis, G., & Fiotakis, K. (2008). Persistent free radicals, heavy metals and PAHs generated in particulate soot emissions and residue ash from controlled combustion of common types of plastic. Journal of Hazardous Materials, 156(1–3), 277–284. https://doi.org/10.1016/j.jhazmat.2007.12.019