Frequently Asked Questions about phthalates and plasticisers
FAQ of the Federal Institute for Risk Assessment (BfR) and the Federal Environment Agency (UBA)
FAQ of the Federal Institute for Risk Assessment (BfR) and the Federal Environment Agency (UBA)
Phthalates are compounds of phthalic acid (1,2-Benzenedicarboxylic acid) with various alcohols (phthalic acid esters).
Phthalates are used mainly as plasticisers for plastics. Their addition is required to give the inherently hard and brittle plastic polyvinyl chloride (PVC) elastic properties and allows it to be used as a soft plastic. The chemical industry produces about one million tonnes of phthalates in Western Europe every year. More than 90% go into the production of soft PVC. They are used, for example, in cables, films, floor coverings, hoses, wallpaper, and sports and leisure articles.
Different phthalates have different effects on the organism. Some representatives of this group are known as endocrine disruptors due to their ability to cause damage to health through changes in the hormone system. Some phthalates may, for example, affect male fertility. For instance, the Member States of the European Union (EU) have classified the phthalates DEHP, DBP and BBP as toxic to reproduction. Di(2-propylheptyl)phthalate (DPHP) has been shown in animal tests to damage vital endocrine glands, the thyroid gland and the pituitary gland (Hypophysis). The latter controls important bodily functions and regulates the body’s endocrine system. With DINP and DIDP, the principal concern is liver toxicity. The different phthalates have been assigned different limit values to protect the health of consumers. In some products, the use of some phthalates is also prohibited.
To date, EU assessments have in all cases referred to individual substances. The possible interaction of two or more phthalates has not been evaluated. In recent times, however, the prevailing opinion has been that phthalates should be assessed as a group because of their potentially cumulative effect.
Phthalates are not chemically tightly bound in soft PVC. They can escape from products as vapour or migrate into other materials – especially fats and oils – when they come into contact with them. Such migrations take place when foodstuffs are packaged in materials made of soft PVC. Phthalates can also get into food during processing, for example, when oil is passed through pipes containing phthalates. Phthalates get into house dust in particular as a result of mechanical impacts – e.g. from floor coverings – and through deposition, e.g. from wallpaper.
Phthalates can now be detected everywhere in the environment. According to the EU, around 95% of DEHP escapes into the environment during product use and disposal and only about 5% during production and finishing.
The Federal Institute for Risk Assessment BfR has estimated DEHP intake as a means of representing that of the other phthalates. To this end, data on the consumption behaviour of children, adolescents and adults in Germany, as well as the various absorption pathways via 37 groups of foodstuffs, toys, consumer products from plastic such as shoes, cosmetics, textiles, household dust and the interior air in cars were taken into account.
The result: Consumers mainly ingest DEHP orally - the main source of ingestion is food. The quantities of DEHP ingested from the various sources are usually so low that there is no health risk. They are below the amount that can be ingested without risk on a daily basis for a lifetime without any occurrence of harmful effects.
Children, especially infants, may be more intensely exposed to DEHP than adolescents and adults. They ingest plasticisers not only through food, but also increasingly via house dust, as well as the many objects that they put in their mouths. Studies in the context of the children and the environment survey of the UBA showed that metabolites of phthalates could be detected in almost all urine samples in the period 2003 to 2006. In 1.5% of children the concentration was so high that it was no longer possible with a sufficient degree of certainty to exclude the possibility of an impact on health. These results confirmed the exposure estimates of the BfR from the year 2012. According to these, in the worst-case scenario a health risk might arise, especially when foods with very high long-term levels of DEHP are consumed.
Added to the exposure to DEHP is exposure to other phthalates which can have similar effects and can thus increase the health risk.
The Federal Environment Agency conducts regular studies in which the degradation products of phthalates are measured in urine samples taken from children and adults. In the Federal environmental specimen bank, degradation products of phthalates were detected in almost all urine samples. These results concur with studies conducted in other industrialised countries.
The objective of the German Environmental Specimen Bank is, among other things, to verify the effectiveness of measures already in force and, where applicable, to propose new ones in order to improve the protection of the population and the environment from harmful phthalates. The studies show that the exposure to some phthalates of young adults in Germany has declined in the last twenty years. In contrast to this, exposure to DINP, which is used as a substitute for DEHP, increased fourfold. During the mid-90s the measured values for DEHP, BBP and DBP reached their maximum. The DIBP concentration did not change over the twenty-year measurement period.
More information about the phthalate measurements of the German Environmental Specimen Bank.
Some phthalates are prohibited in certain consumer products due to their harmful properties.
The reprotoxicity of the phthalates DEHP, DBP and BBP means that they have generally been banned in the EU since 2005 in childcare articles and toys. Other phthalates of concern which are often used as alternatives to those already mentioned, such as DINP, DIDP and DNOP (di-n-octylphthalate), in toys and baby articles which children put in their mouths are not permitted.
Phthalates which have been classified as reprotoxic may in accordance with the EU chemicals regulation REACH not be added to mixtures, such as paints, adhesives and fragrances, which are sold to the general public.
As far as the use of phthalates in plastic food packaging is concerned, certain limits apply to their migration to food; on the other hand, certain usage restrictions, such as bans on their use or regulations prohibiting their contact with fatty foods and infant and toddler food, are in force.
The EU cosmetic directive bans the use of some phthalates, including DEHP, BBP and DBP, in cosmetics.
Phthalates used to be used in food packaging, such as twist-off lids or clingfilm. From these they would migrate into the food. In 2005 the BfR recommended that DEHP should be no longer used in materials for food packaging. Since 2007 far-reaching restrictions have been in place on the use of certain reprotoxic phthalates – such as DEHP – in relation to their use as plasticisers in food packaging. Other plasticisers or phthalates with less harmful properties are used instead in the manufacture of food packaging.
There are numerous phthalates which are safer from a toxicological point of view, such as DINP and DIDP, which can be used as an alternative to reprotoxic phthalates. These alternative substances have a higher TDI (tolerable daily intake), i.e. the amount that can be ingested daily for a lifetime without risk to health is significantly higher than is the case with the phthalate DEHP. This also applies to numerous plasticisers made of other substance classes such as epoxidised soya bean oils, adipates, citrates, adipic polyesters or cyclohexanoates. Health assessments were conducted for all these substances, for instance, in the context of their use in plastics designed for contact with food, from which limit values for their harmless migration into food were derived.
In Germany, it is the supervisory authorities of the Länder which are responsible for monitoring the prohibitions. These mostly form part of the environmental or consumer protection ministries of the respective federal states.
With consumer products, consumers have the opportunity to ask the manufacturer, importer or retailer whether reproductive harmful phthalates are included. The UBA has provided an appropriate query form at Reach-info. Consumers need to state only the bar code on the product. A response must be forthcoming within 45 days. This right to information is enshrined in the EU chemicals regulation REACH. This applies irrespective of whether there is an intention to buy the product.
All staple foods, such as fats, bread, fruit, vegetables and milk or dairy products, can contain plasticisers. Consumers may not know whether a foodstuff is contaminated. This can be determined only by a laboratory test. In general, foods contain no harmful concentrations.
The BfR recommends that consumers who want to further reduce their intake of the plasticiser DEHP should have a varied diet, prepare fresh food, eat few ready meals and switch brands more often, because, depending on the manufacturer, the same products may contain varying amounts of DEHP.
Floors and carpets should be cleaned regularly to reduce the level of binding of the chemical to house dust. It is important also to ensure that infants put only those things in their mouths that are manufactured and designed for the purpose. Although DEHP is prohibited in toys, the substance is occasionally found in such products. This is shown by alerts issued by the European rapid alert system RAPEX. Older toys sold before the enactment of the ban can also represent a potential source of ingestion.