Myths Vs. Reality - VinylPlus Healthcare

Misinformation about polyvinyl chloride, known as PVC or vinyl, in healthcare and beyond is widespread. While NGOs often lead these narratives, other voices also contribute to spreading misconceptions. This page separates fact from fiction, debunking common myths with the latest evidence and research.

Myth

“The use of PVC-free materials such as silicone, polyolefins, polyethylene, polypropylene, polyethylene, or polyurethane represent a more precautionary approach. Using these substances where possible and appropriate reduces the use of potentially harmful plasticisers or additives and reduces the hazards associated with producing, using, and disposing of PVC medical devices.”

Health Care Without Harm Europe. (2023). Towards PVC-free healthcare: Reducing environmental impact and exposure to harmful chemicals. https://global.noharm.org/sites/default/files/documents-files/7382/2023-05-Towards-PVC-free-healthcare_0.pdf. p. 19

Reality

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.

According to the European Chemicals Agency (ECHA), risks from PVC 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 also demonstrate the safe recycling of PVC medical devices into durable healthcare applications such as wall covering.

DEHP-free vinyl solutions are now available, meeting stringent safety and quality standards for healthcare applications.

PVC stands out for its unique combination of flexibility, durability, and adaptability, which make it ideal for critical medical applications such as IV bags, tubing, and containers. These characteristics are challenging 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 issues with shape retention and durability during freezing and thawing cycles, which are critical 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, which require careful evaluation. For instance, the classified phthalate DIBP has been shown to migrate from PP- and PE-based products. It is possible that the DIBP originate from the catalyst mixture used in the production of these polymers.

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

PlastChem (2024). State of the science on plastic chemicals. https://plastchem-project.org

Tegengif. (2024). Report on plastic drinking bottles. https://www.tegengif.nl/wp-content/uploads/2024/09/report_plastic_drinking_bottles_2024.pdf

United Nations Environment Programme & Secretariat of the Basel, Rotterdam and Stockholm Conventions. (2023). Chemicals in plastics: A technical report. https://www.unep.org/resources/report/chemicals-plastics-technical-report

Myth

"PVC use in medical devices is known to carry health risks, and some alternatives have been designed, including PVC-free blood bags."

Health Care Without Harm. (2022). Plastics and health - An urgent environmental, climate and health issue. https://noharm-global.org/plastics_and_health. p. 7

Reality

Polyvinyl chloride (PVC or vinyl) has been used in medical devices for over 70 years with no observed adverse effects. On the contrary, vinyl-based medical applications have played an essential role in saving countless lives.

While alternative materials exist for many applications, they often lack PVC’s unique combination of safety, durability, and performance. In some cases, substitutions may introduce new chemical concerns or unintended risks that require further evaluation.

PVC remains the only material that meets the strict requirements for blood bags, ensuring that red blood cells can be safely stored for up to 49 days. This extended storage time is crucial for patient safety, particularly for individuals with rare blood types.

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

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

European Commission. (2004). Commission Directive 2004/33/EC, Annex IV, L 91/35. https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:091:0025:0039:EN:PDF

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

PlastChem. (2024). State of the science on plastic chemicals. https://plastchem-project.org

PVCfreeBloodbag. (n.d.). PVCfreeBloodbag. https://pvcfreebloodbag.eu

Tegengif. (2024). Report on plastic drinking bottles. https://www.tegengif.nl/wp-content/uploads/2024/09/report_plastic_drinking_bottles_2024.pdf

United Nations Environment Programme & Secretariat of the Basel, Rotterdam and Stockholm Conventions. (2023). Chemicals in plastics: A technical report. https://www.unep.org/resources/report/chemicals-plastics-technical-report

Myth

"Most vinyl chloride is used to make polyvinyl chloride (PVC) plastic, which poses significant health and environmental problems that have been known for over 50 years."

Enck, J. (14 December, 2023). EPA Begins Process to Prioritize Five Chemicals for Risk Evaluation Under Toxic Substances Control Act. Environmental Protection Agency. https://www.epa.gov/newsreleases/epa-begins-process-prioritize-five-chemicals-risk-evaluation-under-toxic-substances

Reality

Polyvinyl chloride (PVC or vinyl) is inert and non-toxic. This challenges the perception of PVC as inherently harmful. The European Chemicals Agency has noted that PVC resin production in Europe has significantly evolved, thanks to stringent environmental regulations and advancements in manufacturing technologies. This evolution has led to a substantial reduction in the environmental and health risks historically associated with PVC production.

Modern vinyl production methods in Europe have been refined to substantially reduce the generation of hazardous by-products. Compliance with the Industrial Emissions Directive (IED) and Best Available Techniques (BAT) Reference Documents (BREFs) has led to significant reductions in emissions. The industry has implemented effective measures to limit the formation and release of Persistent Organic Pollutants (POPs), and strict safety protocols are in place for managing Vinyl Chloride Monomer (VCM) and Ethylene Dichloride (EDC) to ensure their safe conversion into vinyl.

Since 1995, members of the European Council of Vinyl Manufacturers (ECVM) have been actively engaged in reducing environmental impacts. Voluntary charters exceed EU BAT reference standards, regulating releases of VOCs, EDC, VCM, dioxins, and hydrochloric acid in VCM and PVC production.

Through VinylPlus, the European vinyl industry has made a targeted effort to substitute unwanted additives in the last two decades. As a result, replacement of lead-based stabilisers was completed in 2015, and low molecular weight phthalates have been substituted to nearly 100% by safe alternatives.

References

European Chemicals Agency. (2023). Investigation report on PVC and PVC additives. https://echa.europa.eu/en/completed-activities-on-restriction

European Chemicals Agency. (n.d.). Substance information for 1,2-dichloroethane. https://echa.europa.eu/substance-information/-/substanceinfo/100.003.145

European Chemicals Agency. (n.d.). Substance information for Chloroethylene. https://echa.europa.eu/substance-information/-/substanceinfo/100.000.756

The European Council of Vinyl Manufacturers. (2019). ECVM Industry Charter for the Production of Vinyl Chloride Monomer and PVC. https://pvc.org/wp-content/uploads/2023/04/ECVM-charter-pages.pdf

European Commission. (2014). Best available techniques (BAT) reference document for the production of chlor-alkali. https://eippcb.jrc.ec.europa.eu/reference

OECD. (2009). ENV/JM/MONO(2009)1. Data Analysis of the Identification Of Correlations Between Polymer Characteristics and Potential for Health or Ecotoxicological Concern. https://www.oecd.org/env/ehs/risk-assessment/42081261.pdf

Myth

"Some materials, such as polyvinyl chloride (PVC), are not considered as eco-friendly as it is made by a chemical reaction, between chlorine, carbon, and ethylene, and causes the release of harmful chemicals, which harms the environment."

Olivia Friett (2022): Editor's Comment: Green and Bear It. Medical Plastics News International - Europe edition - Oct/Nov/Dec 2022. https://www.medicalplasticsnews.com/medical-plastics-resources/medical-plastics-news-europe/medical-plastics-news-international-europe-edition-octnov-de. p. 7

Reality

Myth

"... [PVC] is often only usable with the aid of toxic additives and cannot be recycled."

Stringer, R. (2023). Over the years... [LinkedIn post]. LinkedIn. https://www.linkedin.com/posts/ruth-stringer-1692621b_in-the-wake-of-the-recent-train-derailment-activity-7034572136056770560-YHaO

Reality

Additives in polyvinyl chloride (PVC or vinyl) and all other plastics are regulated by the EU REACH regulation. Under REACH, the responsibility lies with the industry to prove the safety of substances - the principle is no data, no market.

Some plasticisers which were previously used in vinyl have been identified as harmful and regulated under REACH: these are the low molecular weight phthalates. The European plasticiser industry has invested over 6 billion Euros over 25 years in developing safe alternatives to low molecular weight phthalates such as DEHP.

These alternatives, such as DINP, DIDP, DINCH, DEHT, BTHC, ATBC, DEHA, DEHCH and TOTM, have been subject to extensive testing under REACH. All toxicological data for these substances are available in the REACH dossiers.

The alternatives are neither identified as Substances of Very High Concern (SVHC) under REACH nor classified in the Classification, Labelling and Packaging Regulation (CLP).

The four alternatives DINCH, DEHT, BTHC and TOTM are also approved for medical devices and have therefore undergone a special test regime. ATBC, DEHA, DINCH, DEHT, ESBO, DEHCH and TOTM are approved for food contact materials.

It is worth noting that several of the alternatives have been used for over 20 years in many critical applications without adverse effects being observed. 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.

Independent assessments by regulatory bodies such as the European Chemicals Agency (ECHA), the European Food Safety Authority (EFSA), and national agencies in France, Denmark, and Sweden have confirmed the safety of these substances for medical use.

The transition to these safe plasticisers ensures that medical-grade vinyl remains a reliable material for critical healthcare applications, such as IV bags, dialysis equipment, and respiratory masks, while addressing concerns related to older additives.

To further enhance transparency and sustainability, the industry has introduced the Additive Sustainability Footprint (ASF) methodology. ASF is a peer-reviewed, science-based tool used to assess the environmental and health impacts of additives used in vinyl products.

This methodology ensures that all new plasticisers and stabilisers undergo rigorous evaluation across their entire lifecycle, from production to end-of-life. ASF has been validated by life cycle assessment (LCA) experts and contributes to the industry’s commitment to continuous improvement in safety and sustainability.

Rigid and flexible polyvinyl chloride (PVC or vinyl) can be mechanically recycled several times without losing its technical properties. This is possible because the recycling process does not measurably decrease the chain length of PVC molecules.

Since 2000, more than 8.8 million tonnes of vinyl have been recycled and reused in new products in Europe through VinylPlus®. Since 2022, this also includes PVC medical devices, which are collected and recycled through VinylPlus® Med. The VinylPlus® PharmPack project is engaged in improving the circularity of PVC-based pharmaceutical blister packaging. All recycling figures are validated by third party.

References

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

Everard, M., & Blume, R. (2019). Additive Sustainability Footprint: Rationale and pilot evaluation of a tool for assessing the sustainable use of PVC additives. Journal of Vinyl and Additive Technology, 26(2), 196–208. https://doi.org/10.1002/vnl.21733

Fumire, J. & Tan, S.R. (2012). How much recycled PVC in PVC pipes? Plastic Pipes Conference XVI, Barcelona. https://pvc.org/how-much-recycled-pvc-in-pvc-pipes

Harmon, P., & 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

Leadbitter, J., & Bradley, J. (1997). Closed Loop Recycling Opportunities for PVC. IPTME Symposium, Loughborough University, 3-4 November 1997. https://pvc.org/closed-loop-recycling-opportunities-for-pvc

VinylPlus (2021). Progress Report 2021. https://vinylplus.eu/wp-content/uploads/2021/06/VinylPlus-Progress-Report-2021_WEB_sp-1.pdf. p. 12

VinylPlus. (n.d.). Additive Sustainability Footprint. https://www.vinylplus.eu/sustainability/our-contribution-to-sustainability/additive-sustainability-footprint

Myth

"When recycling PVC, the toxic chemicals will remain in the new products."

Health Care Without Harm Europe (2022): Training on Circular Economy in Healthcare. Bristol, 9-10 November 2022. https://www.linkedin.com/posts/dominika-maria-ja%C5%9Bkowiak-executive-mba-907a251b2_training-sustainable-video-activity-7001290288723816448-DUZH?utm_source=share&utm_medium=member_desktop.

Reality

Myth

"PVC's versatility ... is only due to the many, various additives used. Often toxic and used in high concentrations, these additives provide the desired characteristics for the products’ application e.g. rigidity/flexibility or opaque/transparent. Achieving the desired functionality of PVC products is therefore associated with serious chemical risk."

Health Care Without Harm Europe. (2021). The polyvinyl chloride debate: Why PVC remains a problematic material. https://noharm-europe.org/sites/default/files/documents-files/6807/2021-06-23-PVC-briefing-FINAL.pdf. p. 6