FAQ
What are plasticisers?
A plasticiser is a substance which when added to a material, usually a plastic, produces a product which is flexible, resilient, and easier to handle. Since the dawn of civilisation, water has been used to plasticise clay for the production of pottery and clay tablets. Also, lime has been used to promote the easier working of cements. Other early examples of plasticisers include the oils to plasticise pitch for caulking prehistoric boats and neatsfoot oil and sperm oil to soften leather.
Plasticisers must satisfy demanding technical and economic requirements which are best met by esters such as phthalates, adipates, trimellitates, etc. Ortho-phthalates, due to their technical performance, versatility, and cost effectiveness, are the most widely used.
Those esters as modern applications plasticisers are produced by reacting an alcohol (such as 2-ethylhexanol, isononyl alcohol or other longer chain oxoalcohols) with a substance providing an acid function such as e.g. phthalic anhydride, adipic acid, etc
What are phthalates?
Phthalates, more precisely ortho-phthalates, are a group of colourless, odourless liquids which are used as plasticisers (or softeners). They are produced by the simple reaction of alcohols with phthalic anhydride and the elimination of water. Both alcohols and phthalic anhydride are well known substances, which have been in use for a long time. Phthalates have very low volatility, do not readily dissolve in water and are not persistent in the environment. Their principal use is to soften polyvinyl chloride (PVC), also known as vinyl. Plasticised PVC is used in a wide range of durable applications such as flooring and wallcoverings, roofing membranes, electrical cable insulation, automotive applications, medical tubing, and blood-bags.
Are phthalates all the same?
Ortho-phthalate esters (Phthalates) are manufactured from alcohols ranging from methanol (C1) and ethanol (C2) up to iso-tridecanol (total carbon chain length C13), either with a straight carbon chain or with some branching. Different applications, differences in eco-/toxicological properties and different classification and labelling under CLP makes clustering in different groups reasonable.
Dimethyl- and Diethyl phthalate have a low molecular weight and are, based on their physical-chemical properties, not suitable to be used as plasticisers, but are used as solvents.
Phthalates with 3-6 carbon atoms in the longest straight chain in the alcohol backbones and also quite low molecular weight, are all toxic to reproduction and accordingly classified and labelled.
Phthalates with 7-13 Carbons in their longest straight carbon chain of the esterified alcohol are connected with a higher molecular weight. Those are are neither classified as toxic to reproduction nor as endocrine disruptors (EDs). Based on their higher molecular weights their volatility is much lower as compared to those with lower molecular weight. Further, depending on the adjacent matrix, their leaching/migration is significantly reduced. Accordingly, exposure of environment and humans is very low which is reflected in very low urinary metabolite concentrations seen in human biomonitoring and low environmental concentrations in different compartments.
What other products, apart from PVC, are phthalates used in?
More than 85% of all plasticisers are used in the production of flexible PVC (P-PVC = plasticized PVC). Ortho-phthalates are one of the most versatile types of plasticisers and they are used mainly in PVC. Phthalates such as Benzylbutyl- (BBP), Diisobutyl (DIBP) or Di-n-butyl phthalate (DBP) have been used used in rubber products, paints, printing inks, adhesives, and sealants.
Those plasticicers are altogether restricted under EU REACH, are substances of very high concern (SVHC) and are listed on the authorization list, i.e. their production and use in the EU would need specific authorisations. Alternatives to those are available on the European Market.
How many phthalates are used in Europe, and what are the principal ones?
In Western Europe, about one million tonnes of phthalates are produced each year. More than 900,000 tonnes are used to plasticise PVC. High molecular weight phthalates represent around 85% of all the ortho-phthalates currently produced in Western Europe. Nowadays, the most commonly used high molecular weight phthalates are diisononyl- (DINP), diisodecyl- (DIDP) and di(2-propyl-heptyl) phthalate (DPHP).
Use of low molecular weight (LMW) phthalates is decreasing in Europe, and they account for less than 11% of the total production, with di(2-ethylhexyl) phthalate (DEHP, also known as DOP) representing the highest remaining but decreasing volume and DEHP is only used in specific applications.
Are phthalates safe?
Phthalates are high-production volume chemicals which are widely used. Accordingly, the substances have undergone extensive testing for potential physical-chemical, health and environmental effects. In Europe, already 2 decades ago both, high and low molecular phthalates have been subject under the existing chemicals legislation to 10-year-long comprehensive scientific assessments which are published on the ECHA website.
For the high molecular weight (HMWs) phthalates (DINP, DIDP, DPHP, DIUP, and DTDP), the risk assessments concluded safe use of these substances.
They have all been registered under EU REACH and based on the available data they do not require classification for health and environmental effects, nor are they on the Candidate List for Authorisation.
Low molecular weight phthalates (DEHP, DBP, DIBP and BBP): Risk assessments have concluded on the available hazard data and have led to their classification and labelling as Category 1B Reproductive agents. Consequently, these phthalates are now on the REACH Candidate List for Authorisation.
Phthalates are found in many household items and some of these items contain more than 50% phthalates. Should this be a cause for concern?
The number of phthalates found in a finished product has little to do with potential exposure. There are many misconceptions about phthalates leaching out and easily dispersing from PVC products. This is actually quite a difficult process and would only happen if very abrasive detergents or solvents are used or if the articles are exposed to adverse conditions for an exceptionally long time.
If DEHP is a low phthalate of very high concern, shouldn’t it be banned in medical applications?
DEHP has been registered under the EU’s Chemicals Legislation REACH. It is classified as a Substance of Very High Concern (SVHC), therefore its uses are subject to Authorisation since 2015.
The use of DEHP in some medical applications is still in Europe, but upon an evaluation of possible alternatives, four new plasticisers have been added to the European Pharmacopoeia:
- DINCH (cyclohexane-1,2-dicarboxylic acid, diisononyl ester)
- BTHC (butyryl tri-n-hexyl citrate)
- TOTM (tris(2-ethylhexyl) trimellitate)
- DEHT (bis(2-ethylhexyl) terephthalate)
These plasticisers can be used for containers and tubing used in human blood and blood components and empty sterile containers of plasticised PVC for human blood and blood components. In addition, these plasticisers are used for the manufacture of tubes in sets for transfusion of blood and blood components. [They are also used in the manufacture of plasticised poly(vinyl chloride) tubes for sterile containers for human blood containing anticoagulant solution..
[1] 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. Link
Is it true that phthalates can leach out of plastic water and soda bottles?
No, this is not true. Phthalates do not leach out of water or soda bottles because bottles do not contain any phthalates. Such bottles are made from polyethylene terephthalate, a plastic material also known as PET. Despite the similarity in name, the polymer PET and phthalates are not the same.
Isn’t the plasticiser industry being complacent and insufficiently responsive in view of all these issues it faces?
The European plasticiser industry is very conscious of the genuine public concern which exists concerning the use of phthalates. The industry welcomes a responsible public debate and accepts that it has a responsibility to respond to public concern by ensuring that there is an open exchange of information about the performance of its products. Clearly, if there was evidence that any single product presented a serious risk to human health,
The plasticiser industry has undertaken massive efforts to show safe use of plasticisers in their intended uses and has further developed new plasticisers to substitute older products under scrutiny.
The industry is also fully committed to supporting and commissioning further scientific research to clarify potential hazards of plasticisers for human health and the environment. The study results are integral part of the respective REACH registrations and many of the studies are published in peer-reviewed scientific journals.
Health Misconceptions
Some low molecular weight ortho-phthalates are classified due to their eco-/toxicological profiles and have been under the spotlight in media and public debates. However, it is crucial to keep in mind that there are lots of different plasticisers with very different chemical structures and not all are the same. They differ in their eco-/toxicological profiles, applications and regulatory status. Using all-encompassing, generic terms such as “plasticisers” or “phthalates” in referring to health and environmental hazards and risks is simply not correct. Some of the conditions most commonly cited in association with plasticisers include:
Health Misconceptions: Asthma
Even in abraded particles that may be collected in the form of dust, plasticisers would remain tightly bound within the PVC matrix. If this were not the case, flexible PVC would not remain flexible and perform as intended. Essential applications such as wire and cable, where electrical safety is paramount, would crack and break rendering them unusable and potentially unsafe for consumers.
Reports linking exposure to phthalates and asthma are often based on finding an association, which does not mean causation.
In addition, recent scientific studies have concluded that plasticiser concentrations measured in household dust donot at all correlate to human exposure levels measured by urinary metabolites in human biomonitoring studies. Accordingly, content of plasticisers in dust in not suitable to determine human exposure or to conclude on indoor air quality1-4.
Therefore, it is not possible to draw any conclusions from levels of plasticisers in dust, especially it is not possible to assume any exceedance of safe exposure limits.
1 H. Fromme et al., “Occurrence of phthalates and musk fragrances in indoor air and dust from apartments and kindergartens in Berlin (Germany), Indoor Air 2003, 1-8.
2Kerstin Becker et al. “DEHP metabolites in urine of children and DEHP in house dust.” International Journal of Hygiene and Environmental Health 207 (2004), 409-417.
3Tobias Schripp et al. “Chamber studies on mass-transfer of di(2-ethylhexyl) phthalate (DEHP) and di-n-butylphthalate (DnBP) from emission sources into house dust”, Atmospheric Environment 44 (2010)
4ECPI Scientific Working Group Report 110301 – “Endocrine Data Evaluation Report” – March 2011.
Health Misconceptions: Carcinogenicity
None of the plasticisers used in flexible PVC consumer goods has been found to be carcinogenic for humans. Extensive research has shown that the liver tumours occurring in animal studies with some ortho-phthalates are not relevant to humans. Lack of relevance of these tumours has also been concluded in the respective EU risk assessments.
Health Misconceptions: Obesity
There have been studies and media reports claiming that obesity could be linked to exposure to phthalate plasticisers used in different application.
Today, only the non-classified DMP and DEP may be used in cosmetics or pharmaceutical products. Both, DMP and DEP are not classified as hazardous substances, nor are these two restricted in the EU.
DBP and DIBP are no more used in cosmetics and body care products in the European Union due to provisions of the European Cosmetics legislation, which prohibits the use of substances classified as carcinogenic, mutagenic or repro-toxic (CMR). Based on their physical-chemical properties other high molecular weight (HMW) ortho-phthalates are not used in these applications.
Obesity or diet? Levels and determinants of phthalate body burden – A case study on Portuguese children
When their BMI is increased this relates to increased caloric intake.