Polyvinyl chloride, PVC, is a synthetic polymer that is still widely used in the production of packaging and materials that come into contact with food, including transparent films intended for wrapping them.
Over the decades, serious risks to human health associated with exposure to PVC have emerged and been recognized, as well as to the environment where it is often released and resists degradation.
However, politics continues to privilege private industrial interests over public health, while consumers are kept in the dark about the composition of plastic materials. Until when?
1) PVC, a success story
PVC, polyvinyl chloride, is a polymer made up of multiple repeating units (monomers) of vinyl chloride. Its first patent dates back to 1913, in Germany. And it is still, more than a century later, the third most produced plastic polymer worldwide (after polyethylene, PE, and polypropylene, PP).
The success of PVC’s popularity is linked to its low production costs, its lightness (weight/volume ratio) and its versatility which has allowed it to be used as an alternative to a series of materials, from rubber to glass, wood and metals, in an infinite variety of industrial applications. (1)
2) Side effects
The strong rigidity and poor flexibility of the base resin, in addition to the low thermal properties that hinder hot working, however, lead to the need to add numerous chemical additives to PVC. Which, in itself, is characterized by:
-high concentrations of chlorine and poor stability, which can cause emissions into the environment of hydrochloric acid and organic halogen compounds, dioxins and furans
-non-biodegradability. PVC is classified among non-biodegradable plastic polymers, which account for approximately 20-30% of the volume of solid urban waste to be disposed of.
The design of these polymers has in fact privileged the physical-mechanical properties for the intended uses. Without dealing with the dangers and poor environmental degradability, which are responsible for the so-called ‘white pollution’ from plastic.
3) PVC in commonly used materials and objects
Commonly used materials and objects which contain PVC are now predominantly subject to the regulation of General Product Safety Regulation (GPSR). (2) Such products include:
-materials and objects in contact with food, from transparent films to jar seals, food freezing bags, as well as various plastic packaging and tableware
-toys and articles made of plastic, including soft and inflatable ones (swimming pools, water sports accessories, trampolines)
-leatherette clothing and upholstery, shoes
-building materials, etc.
4) PVC in materials in contact with food, what are the rules?
The materials and objects in contact with food made of PVC and marketed in the European Union must comply with a series of rules, the structural reform is long overdue:
–Food Contact Materials Regulation (EC) No 1935/2004 (FCMR); to which are now added the responsibilities established in the General Product Safety Regulation (EU) No 2023/988;
–Good Manufacturing Practices (GMP) Regulation (EC) No 2023/2006, to ensure the absence of risks to consumer health, with specific regard to the migration of substances from ‘food contact materials’ to foods;
–Plastics Regulation (EU) No 10/2011. Severe restrictions are imposed on the use of vinyl chloride (PVC monomer), even in multilayer and multimaterial. The migration of this substance is not allowed and its presence in the finished product must be < 1 mg/kg.
Regarding the subject additives, There are only 18 restrictions or limitations in the EU on PVC intended for food contact materials. Some of them, such as epoxidized soya oil, have already been found not to comply with the general requirements, due to their migration into food. However, certain derogations are foreseen for additives authorised by national legislation and present in the provisional list (containing mainly biocides) until a decision by the Commission (3) while certain substances not present in the EU list may still be used, such as:
– polymerization process aids, colorants and solvents in the manufacture of plastic layers subject to national legislation;
– mixtures of authorised substances without chemical reaction of the components;
– natural or synthetic polymeric substances with a minimum molecular weight of 1.000 Da (excluding macromolecules obtained by microbial fermentation) capable of functioning as a structural component;
– unintentionally added substances or polymerization auxiliaries may be present.
5) Cancer risks, IARC assessments
International Agency for Cancer Research (IARC) has evaluated and included vinyl chloride monomer – used almost exclusively for the production of PVC – in Group 1 (evidence of carcinogenicity in humans and animals).
In fact, in numerous scientific studies, scientists have highlighted a possible increase in the risk of various tumors (i.e. liver, brain, lungs, skin) associated with exposure to vinyl chloride, especially among professional workers. (4)
Remarks tests were also conducted on PVC, whose evaluation by IARC – with classification in Group 3 (insufficient evidence) – dates back to 1987. (5) The release of the monomer in drinks and foods packaged or wrapped in PVC cannot obviously be excluded.
6) EC, Green Paper on PVC (2000)
The European Commission – in the Green Paper on environmental and health issues related to PVC (2000) – analysed the overall use of this polymer in the various production sectors (e.g. packaging, construction, furniture, household appliances). (6) The main critical issues found concern:
– environmental emissions and safety at work. PVC has a chemical structure similar to that of polyethylene, from which it differs by the presence of chlorine (about 57%). Its production, by means of suspension or emulsion of vinyl chloride, involves emissions of chlorine, ethylene and other substances used for the synthesis of monomers. Uniform rules on worker protection are therefore necessary; (7)
– toxicity of additives. Additives are added to PVC to provide the resin with the required properties. Many of these additives (stabilizers, plasticizers, lubricants, pigments, fillers), in addition to their intrinsic toxicity, can cause problems due to the presence of lead or cadmium;
– waste management. Already at the time of the Green Paper in question (2000), landfill disposal represented the primary fate of PVC at the end of its life. Its continued diffusion and the long periods that can elapse between use and disposal allowed us to predict a significant increase (+80%) of PVC waste in which a growth of up to 80% of waste was attributed in the 20 years that have since passed;
– import/export. PVC production, historically concentrated in a small group of industries in the USA, Japan and Europe, has then seen the rise of China and Egypt which have entered the market as top players in the sector. Added to the general issue of the environmental impact of transport are the risks of dumping, which have recently led the EU to apply provisional duties on PVC arriving from the USA and Egypt. (8)
7) European Parliament, resolution on PVC (2000)
The European Parliament of the time, in a resolution (2000) on the Green Paper mentioned above, called for the integration of this proposal with some elements not considered by the Commission:
– application of Life Cycle Assessment (LCA), for a complete assessment of the environmental impact of PVC compared with alternative materials;
– adoption of a draft horizontal strategy for the substitution of PVC;
– application of the ‘polluter pays’ principle to PVC;
– implementation of measures to ensure separate waste collection and the adoption of a recycling system similar to that provided for scrapped cars;
– implementation of bans on the use of lead and cadmium;
– mandatory labelling for plastic materials. (9)
8) Consumer safety and health, the overlooked risks
The Green Book of the Commission on environmental problems related to PVC (2000), it should be noted, was limited to considering the production of PVC and its various industrial uses. Focusing attention on their environmental impact and worker safety.
Public health risks associated with the overall exposure of humans to PVC have been completely overlooked. These risks deserve particular attention, considering:
-the extraordinary diffusion of this polymer in a large variety of products
-scientific evidence on serious dangers (carcinogenesis and mutagenesis, endocrine disruption, premature mortality, etc. See next paragraph 12).
9) European Commission, mild restrictions on heavy metals
23 years later the adoption of the Green Paper, the Commission adopted Regulation (EU) 2023/923 to introduce mild restrictions on the presence of lead in PVC polymers or copolymers, so as to prohibit their placing on the market in the case of concentrations > 0,1%. (10) The proposed regulation even contained some derogations for flexible and rigid PVC, which were later rejected by the European Parliament. (11) The implementation times of the new rules are also extended beyond measure, with broad derogations:
– ban on the placing on the market or use of lead (≥0,1%) in PVC, starting from 28 November 2024. 28 May 2025 for PVC containing recycled flexible PVC;
– marking ‘contains ≥ 0,1% lead’ for various articles (mainly in the construction sector, excluding drinking water pipes) containing recovered rigid PVC, with lead concentration < 1,5%, by 28 May 2033;
– these rules do not apply in any case to materials subject to specific regulations, such as the Food Contact Materials Regulation (EC) No 1935/2004.
Restrictions on the presence of cadmium were in turn introduced by Regulation (EU) No 494/2011.
10) EU Restriction Roadmap (2022)
EU Restriction Roadmap – presented by the von der Leyen Commission in the previous legislature, on 25.4.22, as seen – had in turn included PVC and its additives in the list of substances to be subjected to severe restrictions (12,13).
The program of the European Commission included among other things a priority list (Rolling List) of substances to be restricted, in the reform of the REACH regulation. PVC and additives were included in the list of substances ‘in an advanced stage of evaluation for the purpose of restriction proposals’ (‘Pool 1’).
The reform systemic implementation of the REACH regulation and several other promises contained in the EU Restrictions Roadmap have remained unfulfilled, as seen.
11) European Commission, 2022 report
A relationship with the European Commission (2022) was drawn up to assess the role of PVC in the context of EU policies. Green New Deal, with particular regard to Circular Economy Action Plan (CEAP), Sustainable Chemicals Strategy and Zero Pollution Action Plan. The situation described is not very different from what is reported in the Green Paper. Except to underline the importance of banning unwanted substances, such as additives, as a necessary condition to ‘improve’ recycling, which is still stuck at the mechanical type (14,15).
The different options of ‘complete ban’ or ‘no implementation’ can both significantly impact aspects of sustainability in the Union, as they affect the promotion of research and innovation on alternative materials and the reduction of risks to human health and the environment. The Commission also takes care to take into account the economic interests of the industries in the sector in continuing to use the century-old toxic polymer, under the pretext of protecting employees and consumers who could suffer from increased costs and lower efficiency of the alternatives.
12) ECHA Report
THROW – European Chemistry Agency – has in turn drawn up a report on PVC and its additives, in order to verify the presence of potential risks for human health and the environment following the most recent scientific data. The main risks linked to PVC, according to ECHA, concern:
-vinyl chloride and dichloroethane (EDC), carcinogenic, used for the manufacture of the polymer
-67 additives (i.e. stabilizers, plasticizers and flame retardants), among the over 470 substances used in PVC, present carcinogenic, mutagenic and reprotoxic (CMR) risks
-polychlorinated dioxins and furans (PCDD/Fs), carcinogenic and genotoxic, generated following combustion and also residues in the dust produced in production processes
-microplastics released into the environment.
Restrictive measures are identified by ECHA as a priority – to reduce the emission of microparticles into the environment – and urgent, to mitigate the problems of water contamination. ECHA therefore recommends restricting the use of permitted additives, managing PVC waste according to the framework directive, tightening exposure limits for operators, encouraging the development of sustainable products as foreseen by the EU Ecodesign Regulation. (16)
13) Civil society, joint action against PVC
Civil society – through the associations and initiatives European Environmental Bureau (EEB), ClientEarth, Zero Waste Europe and Health Care Without Harm (HCHW) – is calling for a complete ban on PVC by 2030. (17) Two reports are highlighted that offer further insights into the serious critical issues of this polymer – PVC – Problem Very Clear. It is noted that the ECHA evaluation failed to consider the risks associated with industrial applications of PVC in various sectors (i.e. medical devices). In addition to the problem of waste, including industrial waste, still incinerated or buried; (18)
– ‘Bye bye’ to PVC in food packaging – once and for all. Food packaging produced with PVC contains as many as 229 chemical substances, many of which are very dangerous to health, which can migrate into food. (19)
Both reports indicate the need and urgency of:
-introduce efficient and safe recycling processes, in a circular economy logic that respects the environment
-replace PVC – in various items such as bottles, jar seals, films, labels and various packaging – with less problematic materials. Cellulose and bioplastics – adds the writer (20,21) – rather than polyethylene (PE), even low density (LDPE), followed by polypropylene (PP) and polyethylene terephthalate (PET).
14) Provisional conclusions
Time has come to relegate to history the toxic chemicals that in the name of great results continue to poison humans, animals and ecosystems. From glyphosate to dicamba, PFAS and PVC.
The PVC case is exemplary because its replacement is possible in many cases, as shown in the aforementioned reports of civil society associations (see paragraph 13 above), without requiring particular efforts or costs.
Industrial operators and retailers can no longer rely on the scarcity and obsolescence of rules to refrain from taking responsibility for the safety of the products they manufacture and distribute. (2)
Customers, on the other hand, cannot tolerate the silence on the composition of plastic materials in food packaging and materials in contact with food. And they will be able to recognize the value of those that are ‘PVC-free’.
Dario Dongo and Andrea Adelmo Della Penna
Footnotes
(1) Alim A. et al. (2022) A Review of Nonbiodegradable and Biodegradable Composites for Food Packaging Application. Journal of Chemistry 7670819 https://doi.org/10.1155/2022/7670819
(2) Dario Dongo, Alessandra Mei. General Product Safety Regulation, at the starting line in the European Union. The ABC. GIFT (Great Italian Food Trade). 13.5.23
(3) https://food.ec.europa.eu/system/files/2016-10/cs_fcm_legis_additives-prov-list.pdf
(4) IARC (2008) 1,3-Butadiene, Ethylene Oxide and Vinyl Halides (Vinyl Fluoride, Vinyl Chloride and Vinyl Bromide). IARC Monographs on the Evaluation of Carcinogenic Risks to Humans Volume 97 https://tinyurl.com/bd87372t
(5) IARC (1987) Overall Evaluations of Carcinogenicity: An Updating of IARC Monographs Volumes 1–42. IARC Monographs Supplement 7 https://tinyurl.com/mpmbht3x
(6) European Commission. Green Paper – Environmental issues of PVC https://tinyurl.com/5cz632s8
(7) European Parliament resolution on the Commission Green Paper on environmental issues of PVC (COM(2000) 469 – C5-0633/2000 — 2000/2297(COS)) https://tinyurl.com/4k23ws7e
(8) Directive 2004/37/EC defines limit values for carcinogens, mutagens or toxic substances that may be inhaled by professional workers. The limit for vinyl chloride monomer is 2,6 mg/m3 at standard conditions and 1 ml/m3 by volume of air, for a reference period of 8 hours.
(9) Commission Implementing Regulation (EU) 2024/1896 imposing a provisional anti-dumping duty on imports of certain polyvinyl chloride (PVC) originating in Egypt and the United States of America https://tinyurl.com/r4u8vp52
(10) Commission Regulation (EU) 2023/923 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards lead and its compounds in PVC https://tinyurl.com/2y3d5xcp
(11) European Parliament resolution on the draft Commission regulation amending Annex XVII to Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) as regards lead and its compounds (D063675/03 — 2019/ 2949(RPS)) https://tinyurl.com/2ftsew9x
(12) Commission Staff Working Document. Restrictions Roadmap under the Chemicals Strategy for Sustainability. https://ec.europa.eu/docsroom/documents/49734
(13) European Commission Communication. Chemicals Strategy for Sustainability Towards a Toxic-Free Environment. COM/2020/667 final https://tinyurl.com/3wnw5pxs
(14) European Commission, Directorate-General for Environment (2022). The use of PVC (poly vinyl chloride) in the context of a non-toxic environment – Final report https://data.europa.eu/doi/10.2779/375357
(15) European Commission (2022). The use of PVC in the context of a non-toxic environment. Annex to the report https://data.europa.eu/doi/10.2779/229448
(16) ECHA’s completed activities on restriction. ‘PVC and PVC additives’ Section https://echa.europa.eu/completed-activities-on-restriction
(17) EU has ‘legal duty’ to ban PVC, NGOs tell European Commission. European Environmental Bureau (EEB). 13.6.24 https://eeb.org/eu-has-legal-duty-to-ban-pvc-ngos-tell-european-commission
(18) Client Earth, Zero Waste Europe, EEB, Health Care Without Harm, #wechoosereuse. PVC – Problem Very Clear https://www.clientearth.org/media/oauld0pq/pvc-problem-very-clear.pdf
(19) Zero Waste Europe. Bye Bye to PVC in food packaging once and for all. July 2024 https://tinyurl.com/7rkbyvpe
(20) VTT develops transparent cellulose film to replace traditional plastic in food packaging. VTT Finland. 6.6.22 https://tinyurl.com/3vxru8a7
(21) José J. Benitez, Pedro Florido-Moreno, José M. Porras-Vázquez, Giacomo Tedeschi, Athanassia Athanassiou, José A. Heredia-Guerrero, Susana Guzman-Puyol (2024). Transparent, plasticized cellulose-glycerol bioplastics for food packaging applications. International Journal of Biological Macromolecules. https://doi.org/10.1016/j.ijbiomac.2024.132956
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
Graduated in Food Technologies and Biotechnologies, qualified food technologist, he follows the research and development area. With particular regard to European research projects (in Horizon 2020, PRIMA) where the FARE division of WIISE Srl, a benefit company, participates.
