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PVC Environmental Frequently Asked Questions

What does 'PVC' stand for?
Polyvinyl chloride. PVC is commonly referred to as vinyl and the two names can be used interchangeably. Vinyl resin can be combined with a wide range of other materials such as plasticisers, stabilisers, lubricants and colorants depending on the requirements of the end product. Not all vinyl products use the same combination of materials.

How much manufactured chlorine goes into the PVC industry?
Worldwide, about 35% of chlorine produced is used in the PVC industry. Chlorine is one of the most commonly occurring elements. Man-made chlorine is vital to many industries producing valuable modern products.

Can people working in the PVC industry contract cancer from vinyl chloride monomer (VCM)?
Vinyl chloride monomer was found to be a carcinogenic substance in the early 1970s. Prolonged and high exposure among those working with the material in the PVC industry was found to cause a rare form of cancer, angiosarcoma of the liver. Once the link was discovered, industry and governments quickly took action to reduce the level of potential exposure. Exposure limits are now below one-thousandth of what they used to be, and no cases of the cancer are known to have been detected in workers joining the industry since that time.

Do VCM or PVC factories emit large amounts of dioxins into the environment?
No. Studies in Australia, the US, UK and the Netherlands have shown that only very small amounts of dioxin can be attributed to VCM or PVC production. Dioxin emissions in Europe and the US have halved in the last thirty years while PVC production has increased 300%. In Australia, it is estimated that 60-80% of dioxin emissions to air arise from agricultural burning off, residential wood combustion and bushfires. The manufacture in Australia of all chemicals based on chlorine (i.e. halogen chemicals) contributes less than 1% to the total. Read more in PVC and Dioxins.

Are dioxins present in the PVC that is used to make everyday products?
No. Dioxins have not been found in PVC polymer at the limits of detection, even using today’s highly advanced measurement techniques. Read more in PVC and Dioxins.

Is PVC cling film safe?
Yes. Plasticised PVC films have been a major contributor to food safety, having properties that both protect and preserve food. Any material used to package food may result in some transfer of its constituents to the foodstuff. The migration of plasticiser from PVC film is at levels which are considered harmless by international health and legislative authorities. All Australian-made films comply with Australian Standard for Plastics and Food Contact, AS 2070.

What are plasticisers and why does PVC require them?
To make PVC soft and flexible, plasticisers are added. A number of different products are used as plasticisers including categories of chemicals known as phthalates (or phthalate esters), citrates and adipates.

Environment groups claim that plasticisers used in PVC disrupt the human hormone system. If there’s any risk of this, should we still be using these substances in PVC?
Phthalate plasticisers have been used worldwide for over forty years and have been extensively studied for health effects. Phthalates are a group of chemicals, each having its own safety and toxicity profile although they can be grouped according to molecular weight into High Molecular Weight (HMW) and Low Molecular Weight (LMW) phthalates. It appears from scientific studies that phthalates generally do not have significant effects on the female hormone, oestrogen. Research has turned instead to the possibility of androgenic effects (that is, effects on the male hormone). Early studies suggest effects may be possible in laboratory animals fed high doses of LMW phthalates. There is some concern about some specific human exposures to DEHP, a LMW phthalate. Refer to the sections on phthalate plasticisers and plasticisers in toys for more detail.

Lead has been known to have been used in PVC products. Should we be concerned?
Lead compounds were traditionally used as heat stabilisers, primarily in rigid PVC such as pipes and gutters. They have been used safely for decades. The stabiliser is tightly bound into the PVC matrix limiting leaching from the surface of PVC and their use is not considered to have contributed significantly to lead in the environment. However, given the community's concern about lead as a toxic hevay metal, and the potential for workers to be exposed to lead in stabiliser manufacturing and use, the industry in Australia (and elsewhere) committed to phase out its use in PVC products. Refer to the section on PVC Stewardship for more detail about this commitment.

What happens when PVC products burn in building fires?
PVC has low flammability and rate of heat release due to its low organic/high chlorine content. Pure PVC will self-extinguish once the external heat or flame source is removed. Rigid PVC materials such as those used for pipe, vertical blinds and siding, are recognised for their excellent fire retardant properties. The fire properties of flexible PVC products depend on the quantity and composition of plasticiser added. Refer to the section on Fire Safety for more information.

Is PVC a danger to people in building fires?
The toxicity of building fire emissions from PVC is neither better nor worse than for many other common materials. The low flammability of many PVC products makes them an asset in a fire situation. When it does burn, PVC tends to produce heavy smoke. However, the most important products in any fire are heat and carbon monoxide. These are produced by all organic materials when they burn. Hydrogen chloride is produced when chlorine-containing materials, including PVC are burnt. It is a common irritant gas, and has a very pungent odour so is quickly detected. At the levels encountered in building fires, hydrogen chloride remains an irritant and is not lethal. To our knowledge, no building fire fatality has ever been attributed to PVC by building fire authorities. Refer to the section on Fire Safety for more information.

Do PVC products cause a waste problem?
Around 85% of PVC is used for long-life products which last for between 15 and 100 years. These are building materials such as window frames, water distribution and drainage pipes and electrical cable insulation and conduit. About 10% of products are used for between two and 15 years such as computer housing, car parts and furniture. Less than 5% is used for short-lived applications such as packaging and things that can only be used once like medical products. On the whole, PVC is not designed to be wasted and does not generate high waste volumes.

Does PVC pollute soil and groundwater when disposed of in landfills?
Studies examining whether PVC pollutes groundwater and soil in landfill show that PVC does not degrade in landfill and is not expected to add to the toxicity of leachate. Minute quantities of metal stabilisers may leach from PVC but the quantities are considered an insignificant contribution to heavy metal concentrations in landfill. Although vinyl chloride gas may be present in landfill, it is formed from the degradation of chlorinated hydrocarbons not from PVC.

Does the incineration of PVC cause the emission of large amounts of dioxins?
It has been demonstrated that PVC in the waste stream of properly operated incinerators has a negligible effect on the amount of dioxins emitted. Dioxin emissions are primarily the result of combustion temperature and efficiency of operation, both of which can be controlled with the use of modern incineration technology. In Australia, municipal waste incineration and halogen chemical manufacture contribute less than 1% to the total dioxin emissions to air. Read more in PVC and Dioxins.

Does PVC material contaminate the recycling of other plastics? Is PVC difficult to recycle?
The successful recycling of any polymer requires an homogenous and clean supply of the material, free from contamination by different types of polymer. This is true in the recycling of PVC and any other major plastic. PVC is as recyclable as any other plastic.

Over its life cycle, how does PVC compare to other materials? Can it be readily substituted for more environmentally benign materials?
Several life cycle, or cradle-to-grave studies have been completed for PVC in some of its major applications (see the section on Life Cycle Assessments). These indicate that the environmental performance of PVC in its major applications is as good, or better than alternative products. In some of its applications, there are few or no readily available alternative materials offering the same or improved beneficial properties. PVC is one of the most thoroughly tested of all materials. Where alternatives do exist, they may not have been subjected to the same degree of rigorous assessment.

How should decisions to select any material be made?
The PVC industry in Australia strongly supports the selection of all materials based on their merits in terms of performance, cost and environmental impact. Expert scientific opinion, where available, should form the basis for environmental comparisons. This principle of selection on merit is the cornerstone for the fair treatment of all materials and delivers benefits to industry and customers alike.

 

PVC Environmental Credentials

All materials and products have some impact on our environment regardless of whether they are 'natural' or 'synthetic'. How 'sustainable' a material or product is largely depends on how it is managed and used throughout its life cycle.

In any selection process, products should be assessed based on their merits in terms of fitness for purpose (performance), life cycle cost and life cycle impacts. In many applications, PVC is an ideal choice.

PVC is one of most well researched and tested materials in terms of environmental credentials. At least 60 reputable lifecycle assessments have been conducted on PVC since 1985 with half of these related to building applications. The weight of evidence from these studies confirms that PVC’s environmental credentials are sound compared to alternative materials. Review the section on Life Cycle Assessments for more information about evaluations of PVC.

Environmental credentials of PVC include:

Resource Management
Over 50 per cent of PVC's feedstock is derived from salt, an abundantly available resource. The remaining 43% of feedstock - ethylene - comes from petroleum, which means that PVC consumes proportionately less non-renewable fossil fuels than traditional polymers. Salt is the source of chlorine in PVC

Relatively Low Energy Content
Because more than half its feedstock is derived from salt, PVC is considered to be one of the least energy intensive of all thermoplastics and it contributes to the relatively low embodied energy in PVC products compared to many other products.

Minimal Pollution
PVC is produced in Australia under regulated and environmentally acceptable manufacturing methods and well within international guidelines for PVC manufacturing. The local resin manufacturer and a number of downstream product manufacturers meet the Best Environmental Practice criteria, independently audited, for manufacturing PVC set by the Green Building Council of Australia's Green Star tool.

Emissions are low and the resin manufacturer publicly provides information on its environmental performance through annual community reports and corporate environment reports (see www.av.com.au).

Material Efficiency
Advances in vinyl formulations have made today’s vinyl products durable, low-maintenance and lightweight, all which translate into reduced use of other materials. For example, high pressure pipes made from oriented PVC (PVC-O) pipes have up to 50 per cent thinner walls while maintaining the same pressure compared to traditional PVC pipes or polyethylene.

Also, through factory and post-industrial recycling, there is little resource wastage during production.

Recycling
PVC is recyclable and recycling programs for PVC occur in Australia, diverting waste from landfill.Check out the pages on Recycling PVC for more detail.

Thermal performance
Vinyl has low thermal conductivity so it can contribute significantly to improving the energy efficiency performance of buildings and reducing greenhouse gas emissions as a result of heating and cooling.

Low maintenance
Vinyl products such as flooring, wall coverings and windows require very little maintenance over their lifespan – both an environmental and economical benefit. PVC windows and cladding, for example, do not require painting or varnishing. Abrasion and impact are not likely to damage PVC, reducing repair. The strength, durability and low maintenance of PVC means products need less frequent replacement, less materials for maintenance and may be made using less material than alternatives.

Competitive life cycle cost
Ease of installation of many PVC products compared to alternatives, greater durability and lower maintenance requirements also make PVC competitive on a life cycle cost basis. This was clearly shown in a

Total Cost of Ownership study in 2011 for key PVC application which found PVC a better option over the lifetime of the product than competing materials. For more detail visit www.pvcconstruct.org

Life Cycle Assessment - LCA Performance

How does one major material, such as PVC, compare on environmental grounds with alternative product performing a similar function? Such comparisons require a detailed 'cradle-to-grave' or ‘cradle to cradle’ assessment of product systems through all stages of their lives. Raw material extraction, product manufacture, use and ultimate disposal are all factors which need to be considered. These comparisons have come to be known as Life Cycle Assessments (LCAs).

LCAs are complex and are usually carried out by independent research organisations and LCA expert practitioners. Globally, at least 60 LCAs have been conducted on a range of PVC products since the mid 1980s. There is usually no clear ‘winner’ as all materials/products have strengths and weaknesses, but there are often some products that perform worse in all life cycle impact categories. To the best of our knowledge, assessments of PVC have never produced that outcome. The findings have generally been neutral to favourable for PVC.

LCA findings are of global interest and the Vinyl Council ensures the data is passed on to Australian industry and stakeholders. Many noteworthy reviews of PVC LCAs have been conducted and released. In particular:

  • the 2004 European Commission (EU) review 'Life cycle assessment of PVC and of principal competing materials'confirms that, in its major applications, PVC is as good an option as its competitors.

  • The Natural Step's evaluation of the sustainability of PVC across its life cycle found: 'Many life cycle analyses (LCAs) have been carried out upon various applications of PVC; probably more than for any other material. Inevitably they are of differing credibility, although the overall weight of them suggests that PVC is no more environmentally unacceptable or unsustainable than alternative materials (including "natural" ones) in the short to medium term.'
    Dr. MarkEverardet al., 2000, 2020 Vision Series No. 2: PVC and Sustainability

  • the Green Building Council of Australia (GBCA) conducted a comprehensive review and assessment of PVC and its use in building products. According to its final report,Background and Outcomes of the Green Star PVC Minimisation Credit Review(2010), it found that “the life cycle of PVC…had changed considerably over the past five years” as the industry addressed some of the historical concerns associated with the material's life cycle. GBCA went on to state that “…environmental and human health risks associated with PVC can be minimised by using best practices in the manufacturing and end-of-life management phases of the PVC life cycle.”

  • The Australian Plastics and Chemicals Industries Association (PACIA) commissioned Australia's pre-eminent scientific organisation, CSIRO, to conduct an independent review and report on whether or not PVC building products were any more harmful to the environment than alternative materials. After a thorough review of the scientific evidence the CSIRO concluded that:‘The adverse environmental effects of using PVC in building products are very small, and no greater than those for other materials.’
    R Smith, 1996, The environmental aspects of the use of PVC in building products,CSIRO

  • Updated editions of the CSIRO review were published in 1998 and 2001, the latest of which states: 'It can be concluded from the evidence sighted in this and preceding reports that the possible adverse human health and environmental effects of using PVC in building products is not greater than those of other materials.'
    P. Coghlan, 2001,A discussion of some of the scientific issues concerning the use of PVC. An update of the CSIRO report "The environmental aspects of the use of PVC in building products, Second Edition, 1998'CSIRO Molecular Science
Monday, 05 June 2017 00:51

Sustainability - Recycling

Recycling

PVC is relatively easy to recycle - if it can be recovered in sufficient quantities and quality.

The best quality is when plastics are well sorted by type. At the the Vinyl Council, we urge people to be super-separators, whether they are involved in our medical recycling program or recycling pipe, cable, banners and flooring, or any other of the many PVC products in the market. The better your sorting, the better the outcome!

In this section you can see the strategy and programs of the the Council and find recyclers who may take your material or sell recyclate to you.

Manufacturers already have high levels of recycling within their businesses, feeding offcuts and their own material back into their own production process. And most will take recyclate - but only if it is 'clean' and not contaminated by other materials.

So when arranging recycling, make sure it is:

  • Free from contamination by other materials ie dirt, other plastics, metals
  • In sufficient quantities to make collection and reprocessing worthwhile
  • Reliable supply, ie ongoing basis, not once only.
  • The material has to be reasonable, consistent quality because recyclers/reprocessors want to:
    • replace virgin PVC in new products
    • replace 'filler' or other material in other products.

Remember, recycling only works if there is someone who wants to take your material because it has a value for using in new products - otherwise it ends up in landfill.

You can contact us with your queries and opportunities for PVC recycling, reprocessing and new product developments.

 

Monday, 05 June 2017 00:46

Sustainability - Stewardship

PVC Stewardship

Product stewardship is an approach to managing the impacts of different products and materials through their life cycle, including end-of-life.

To us at the Vinyl Council of Australia (VCA), it means "the shared management of the health, safety and environmental aspects of PVC products through their life cycle" .

The aim of the Australian PVC Stewardship Program (the Program) is to enable raw material suppliers, products manufacturers and distributors to be joint stewards of the safe and beneficial production, use and disposal of PVC products. All are to share in the management of health, safety and environmental aspects of PVC products throughout their entire life cycle.

The Program supports the Australian PVC industry to work as one to address issues. We see this as a great advantage for our industry, and an important way to foster innovation. It provides a level playing field for all Signatories to progress towards our common objective of a more sustainable industry.

A short history of the PVC Stewardship Program

The VCA was created in 1998 as the peak body representing the Australian PVC industry. In 2001, VCA commissioned the CSIRO to review the life cycle of PVC products and highlight potential concerns. The CSIRO's findings, followed by an extensive stakeholder consultation, formed the basis of the PVC Stewardship Program, a voluntary initiative launched in the following year.

Today, over 40 companies are Signatories to the Program, representing the majority of the Australian PVC industry. These companies include manufacturers of PVC resin, additives and end-products, PVC compounders and product importers. All major PVC applications are represented in the Program, including companies manufacturing or importing packaging, cables, windows, flooring, pipes, formwork, medical products, and profiles.

The Vinyl Council recognises that PVC products add significant benefit to society, including environmental benefit, as a function of their excellent performance, durability and affordability.

Monday, 05 June 2017 00:44

Sustainability

Sustainability

Most of us use polyvinyl chloride (PVC, or vinyl) everyday.

Through the Vinyl Council of Australia, the Australian PVC industry shares information about the health, safety and environmental performance of PVC at every stage of its life cycle. This dialogue is an important way for all stakeholders, including the community at large, to help achieve our goal of a sustainable industry.

Through the Council-led PVC Stewardship Program, companies report on the processes operating at their plants and on their products. The Vinyl Council also receives data on the latest global scientific developments. We endeavour to present research findings in a balanced manner and to update information as new scientific findings are published. We provide information and invite dialogue as part of meeting our commitments within our PVC Stewardship Program.

This section includes information on

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Please This email address is being protected from spambots. You need JavaScript enabled to view it. if you have any queries or would like to meet with us to discuss the vinyl life cycle.

Monday, 05 June 2017 00:42

About Vinyl - Innovative PVC

Innovative PVC

Innovation opens doors to Advanced Manufacturing techniques for vinyl
Australian manufacturer and Vinyl Council member, Chemson Pacific has developed an innovative world first thermoplastic PVC formulation, designed specifically for the Advanced Manufacturing sector and associated 3D printing technologies.
Read More...

Go Trenchless with Fusible PVC pipes
Probably the most significant issues for pipeline systems are those of corrosion, breaks and leaks. The use of trenchless technologies to repair and replace old piping infrastructure will become increasingly important and is expected to become the most widely accepted technology by the major utilities in the US.

A new generation of PVC continuous trenchless pipelines has been used successfully in New Zealand, the US, Canada and Hawaii and is now available to engineers in Australia from Iplex Pipelines.
Read More...

Major worldwide sporting venues again use PVC to meet sustainability goals
When creating new stadiums and sporting venues, a positive trend for designers, architects and builders is to create spaces that are environmentally sustainable, both during major events and in the years to follow.

Arup Associates’ showcase stadium for the 2022 FIFA World Cup in Doha, Qatar is said to be the world’s most sustainable football arena. Alongside photovoltaic cells and solar collection to power the artificial climate control, the stadium used a newly developed PVC fabric to help deliver a carbon neutral venue.
Read More...

Product Enquiries

The Vinyl Council of Australia is an industry organisation whose purpose is to advance the sustainability and development of the Australian PVC industry.

The Vinyl Council does not directly sell or market any branded products or raw material, although our members may be engaged in such activity.

The Vinyl Council cannot provide information on prices, quotations, product availability, or other trade enquiries.

We are happy to respond to enquiries about the generic properties of PVC or PVC applications and the environmental aspects of PVC where such information is not provided on our website.

Monday, 05 June 2017 00:37

About Vinyl - Using Vinyl

Using Vinyl

Most of us use polyvinyl chloride (PVC, or vinyl) everyday.

Around our homes, PVC is used in a wide range of products: pipes for our fresh water, drainage pipes, floor coverings, window frames, cabling, toys, pool membranes, kitchen cabinetry, wall cladding and food packaging.

PVC is equally useful at work where you will find PVC in furniture, stationery and in the equipment we use.

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Not only can PVC be made into rigid or flexible products, it can be made as either a coloured or transparent material. Other properties are:

  • Cost effective.
  • Durability.
  • Resistant to light.
  • Heat resistant.
  • Low maintenance.
  • Flame retardant.
  • Recyclable.
  • Low electrical conductivity.
  • Impervious to water and many other liquids.
  • Hygienic and easily cleaned.

Not surprisingly, PVC is the one of the most common plastics and has been in wide scale use for over 60 years. It is one of the most researched and thoroughly tested materials in the world. It meets Australian and international standards for safety and health for the applications for which it is used.

Plasticisers for Flexibility

Plasticisers are a range of substances with varying chemistries and molecules used to make things soft and flexible. Some examples of plasticiser use are described in the table below.

PVC Uses for plasticiserNon PVC Uses for plasticiser
Labels Fragrance bases for perfumery and cosmetic products
Coatings Personal care products
Flooring Adhesives
Automotive Parts Paints
Cable & wire sheathing / insulation Cellulose acetates
Hoses Household cleaning products
Gaskets Printing inks
Film and Sheets Textiles and other leather treatments
Toys Solvents
Inflatable Items Polypropylene and fibreglass manufacture
Carpet backing  

 

The most common plasticisers include esters such as adipates, azelates, benzoates, citrates, cyclohexanoates, orthophthalates, terephthalates and trimellitates. They are produced by reacting an alcohol with an acid.

Today there are around 50 plasticisers in commercial use. Globally, approximately six million tonnes of plasticisers are consumed every year, with the major use being flexible PVC applications. Plasticisers transform the physical properties of PVC as well as other polymers, creating a wide range of flexible and durable applications. Orthophthalates are the most widely consumed type of plasticiser.

Global Plasticiser MarketGlobal Plasticiser Use






What are orthophthalates?
Orthophthalates (“phthalates”) are a group of chemical plasticisers that are commonly added to PVC and other materials to make them flexible. They may be found in every day PVC products such as electrical cables, hoses and flooring, as well as life-saving medical devices including intravenous tubing and blood bags. They are also used in non-PVC industries and processes such as coatings, rubber products, adhesives and sealants.

Different phthalates for different uses
Phthalates are broadly divided into two groups – ‘high’ and ‘low’ according to their molecular weight and the number of carbon atoms in the backbone of the molecular chain. The groups have very different applications, toxicological properties, classification and legal requirements.


DEHP, or Bis(2-ethylhexyl) phthalate molecular structure (C6 carbon backbone)

High molecular weight phthalates
Globally, high molecular weight (HMW) phthalates (C7-C13 carbon backbone) are recognized as being safe for use in all current applications. DINP, or diisononyl phthalate, is an example of a HMW phthalate that has been used for decades in a wide range of products such as flooring, toys and roofing membranes.

Low molecular weight phthalates
The use of low molecular weight (LMW) phthalates (C3-C6 carbon backbone) is generally restricted, with some exceptions for DEHP, or Bis(2-ethylhexyl) phthalate, in medical devices. DEHP plays a vital role in medical products such as blood bags, IV fluid bags, and providing exceptionally good flexibility to tubing to ensure efficient flow of fluids and drugs.

Non-phthalate plasticisers
The plasticiser industry has responded to media attention and consumer concerns about phthalates. Ongoing innovation in plasticizer science has led to alternative solutions, such as bio-based plasticisers, becoming available to manufacturers. However, while non-phthalate plasticisers show promise, they will still need to undergo extensive risk assessment and scientific scrutiny.

Human health and phthalates
After 50+ years of use, there is no empirical evidence that phthalates cause harm to human health. They are metabolised and excreted quickly and are not bio accumulative. Phthalates have become one of the most studied groups of chemicals in industrial use. Since the 1970s, they have been scrutinized to understand their potential to cause serious health impacts including endocrine disruption and cancer in humans. Two types of studies have caused concern:

Studies measuring phthalate metabolites in human urine - The presence of phthalate metabolites in human urine has been associated with health effects such as diabetes and low fertility. However, correlation does not mean causation, and there are no definitive causal links between phthalate exposure and human health impact.

Studies on rodents exposed to phthalates – Rodents exposed to high doses of LMW phthalates have demonstrated health impacts . However, the impact is not replicated in marmoset primate studies (a species thought to better reflect human metabolic pathways). DEHP exposure in marmosets has demonstrated no adverse effects, even after exposure in-utero, which suggests adverse findings of rodent studies can be considered a worst-case scenario.

Three factors are important in determining the level of risk:

  • Life-stage during exposure: male foetuses and neonates appear to be a sensitive sub-population;
  • Dose delivered e.g. extracted from product during a medical procedure; and
  • Route of exposure (i.e. oral, intraveneous, skin etc) as this influences the circulating concentration of the active metabolite.

While concerns have been raised about the potential impact of short term, high exposure of male foetuses and neonates to DEHP during critical medical care procedures, the benefits of the medical devices are generally considered by regulatory authorities to outweigh the risks of use.

Human exposures to the phthalates of most concern are generally thousands of times lower than the lowest adverse effect levels for these phthalates, even in the most sensitive animal species.

“…Studies in humans did not report significant adverse association between DEHP exposure and parameters of reproductive system function or development in adults or neonates.”
National Industrial Chemicals Notification and Assessment Scheme (NICNAS), Australia, 2010

“…DEHP-containing plasticized PVC devices are important for many treatments…they are justified because of the benefits of these procedures.”
Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), Europe, 2014

Regulations on plasticiser use

HMW phthalate plasticisers
The use of the HMW (“high”) phthalates such as DINP, DIDP and DnOP, is not restricted in Australia. Comprehensive risk assessment reports on DINP, DIDP and DnOP conducted by the Australian chemical regulatory authority, NICNAS, found these phthalates safe for existing uses. In Europe, HMW phthalates are not classified and don’t require authorization for use under the region’s REACH legislation. Some jurisdictions (Europe, United States, Canada) have imposed precautionary restrictions on the use of DINP and DIDP for toys and childcare articles that can be placed in the mouth.

Regulatory overview in Australia 

 Regulatory Situation for Phthalates in Australia pa 2019 Update p1

Information sources for table above: NICNAS 

LMW phthalate plasticisers
DEHP is currently approved for use in medical devices across most jurisdictions. An exception is France, where its use in medical tubing for peadiatric and maternity wards has been restricted from July 2015. LMW (“low) phthalates have generally been restricted in toys, childcare articles and cosmetics for several years in the US, Canada and Europe. To date, eleven LMW phthalates classified as Category 1B reproductive agents have been identified as Substances of Very High Concern (SVHC) and placed on the REACH Candidate List. The European Union generally appears to be encouraging an orderly move to alternative plasticisers, particularly in medical devices, adding suitable alternatives to the list of allowed additives under EU Pharmacopoeia.

While there are no restrictions on the use of DEHP in Australian medical devices, it is banned in Australian cosmetic products and is limited to a concentration of 1% in children’s plastic products.

Across the United States, Canada and Europe, all agencies have stated that when considering limiting the use of DEHP in particular medical devices and/or procedures, it is important to consider benefits, as the health benefits of the medical procedures might outweigh any risks. A recent Danish study1 on the feasibility of non-phthalate alternatives has found that the technical applicability of DEHP substitutes requires further assessment to ensure patient safety and appropriate disease treatment.

Read more about LMW phthalate use in PVC medical devices.

Non-phthalate plasticisers
Regulation for non-phthalate plasticisers is relatively new as global understanding of the safety and efficacy of these alternatives develops. There are currently no restrictions on non-phthalate plasticizer use in Australia and some are already registered for use in Europe. The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) published the following Preliminary Opinion on the safety of medical devices containing DEHP-plasticized PVC or other plasticizers on neonates and other groups possibly at risk in September 2014: “The potential for replacement of DEHP in these products should be considered against their efficiency in the treatment, as well as the toxicological profile and leaching properties of the alternative materials. There is a strong need to develop and collect data on the toxicological profile and exposure of alternative materials.”

The future for responsible plasticiser use in Australia
Phthalate plasticisers continue to play an important, monitored and safe role in modern life. The Vinyl Council of Australia takes the community’s environmental and human health concerns seriously. We continue to advocate for sound science and the safe use of PVC products.

Our PVC Stewardship Program supports the innovation and improvement of manufacturing processes and products in our sector. The safe and sustainable use of additives is a core requirement for Program signatories. Signatories must report when they are using low phthalates and support regulatory authorities in measures that encourage the market to cease the use of low phthalate plasticisers in an application where credible scientific authorities show evidence of unacceptable health or environmental impacts.

Compliance with the Best Practice PVC verification scheme requires products to be free of low phthalates.

For more information on phthalates, please visit plasticisers.org.

1 Danish Ministry of the Environment, Environmental Protection Agency, Alternatives to classified phthalates in medical devices Environmental Project No. 1557, 2014.