Safety assessment of phthalates

Safety assessment of phthalates - Vinyl Council Australia

In common with any situation where chemicals are used in the manufacture of consumer products, phthalates use has been, and continues to be, closely studied to ensure safety. The health and environmental concerns have been extensively examined since the 1980s.

As a plasticiser to make the polymer flexible, the phthalate compound is not tightly bound into the polymer matrix. Consequently, phthalates may migrate from a product during use. In the general population, phthalate migration from everyday products is not considered a risk – the chemicals do not accumulate in tissue and they are rapidly metabolised.

The phthalates most thoroughly reviewed are DEHP, particularly its use in medical devices, (Plasticisers in medical devices) DINP and DIDP. DINP and DIDP are used in applications such as cable sheathing, flooring and toys.

DINP, DIDP and DBP Assessments

The European Commission has completed comprehensive risk assessments on all major phthalates. In April 2006, the European Union formally published its risk assessments for DINP and DIDP. The assessments confirmed that these plasticisers are not classified as hazardous and pose no risks to human health or the environment from their current use. These comprehensive assessments mark the end of a 10 year process of scientific evaluation by regulators.

Information on these risk assessments can be found at the websites: www.dinp-facts.com/RA and www.didp-facts.com/RA.

The EU’s risk assessment of lesser used, DBP, has also been published. It recommended some additional occupational exposure safety measures to be taken.

DEHP Assessments

In 2008, the European Commission’s risk assessment of DEHP was finalised and published. It confirmed that DEHP poses no risk to the general population and that no further measures need to be taken to manage the substance in any of its key end-use applications.

The risk assessment concluded that existing control measures for adult exposure to DEHP were adequate; however, it suggested a need to reduce exposure to children from DEHP in toys and childcare articles. The implementation of Directive 2005/84/EC which prohibits the use of DEHP in toys and child-care articles in Europe from January 2007 reduces this risk. Restrictions are in place in some other overseas jurisdictions for the use of phthalates in toys (About PVC > PVC in our Lives > Toys ) and children’s articles.

The European risk assessment reported that the level of DEHP breakdown products measured in human urine showed that the intake of DEHP is low and is not a concern for the general population. It found use of DEHP was safe in a large variety of indoor and outdoor applications.

The European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) was asked to evaluate the exposure to DEHP for the general population and patients during medical procedures. In its published Opinion the Committee found there is reason for some concern for prematurely born male neonates although follow-up studies after high DEHP exposures in neonates do not indicate there is an effect of DEHP on the development of the human male reproductive system.

The Opinion also said that some other patient groups with relatively high DEHP exposures, including male foetuses of pregnant women may also result in some risk. The Committee noted that alternatives to DEHP-plasticised PVC medical devices exist; however, it pointed out that as it may be difficult to obtain the same functionalities in certain medical devices as with those made of DEHP-plasticised ones, the risk and benefits of using alternatives should be carefully evaluated on a case by case basis.

More detail about the DEHP risk assessment can be found at www.dehp-facts.com/RA

Phthalates, like all other chemicals will be subject to the implementation of the new European chemical regulatory process, REACH.

In Australia, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is conducting a long-term assessment on phthalates use. Please see the next section for more detail.