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Some plastic components, e.g. certain softeners, have a similar chemical structure to the naturally occurring sexual hormones oestrogen and testosterone. There are fears that these substances, also known as "xenohormones", can deceive the human body into thinking that sexual hormones are present. Hormones act as chemical messengers and even in very small concentrations control highly sensitive metabolic and developmental processes. Since scientists have found that some plastic components show similar effects to sexual hormones, the concern has been correspondingly high.
The best-known example, the chemical Bispehnol A, demonstrates clearly how widely the opinions of the experts differ. Bisphenol A has a similar chemical structure to the female sexual hormone oestrogen. Researchers at the European Food Safety Authority (EFSA) have come to the conclusion that current exposures to Bisphenol A do not present a health risk. Other scientists have issued warnings that in small children and pregnant women in particular, even tiny concentrations might impair their health. Note the use of the word “might” here - there is as yet no proof.
However, in line with the precautionary principle, Bisphenol A has been banned from baby bottles since 2011. In the toy sector, too, there have been statutory restrictions since 2014, but below the threshold (0.1 milligrams per litre artificial saliva) its use is basically still permitted. Nevertheless many manufacturers are responding to pressure from consumers by testing their products and advertising them as BPA-free.
However, simply excluding Bisphenol A does not mean the issue of hormonally active agents has been settled once and for all. Other hormonally active agents have been detected in plastics, including some of the products used to replace Bisphenol A. According to a highly regarded study by scientists at the University of Texas, for example, hormonally active agents were detected in most Bisphenol A substitutes tested (Source: http://www.ehjournal.net/content/13/1/41).
It is not that easy for toy manufacturers to guarantee that the products do not contain any hormonally active agents. For a lot of materials and additives there is simply not enough data available about their endocrine effects. Without the appropriate tests, many manufacturers cannot give any accurate information as to whether their products are actually free of hormonally active agents. In order to be sure that a product does not contain any hormonally active agents, a direct analysis of each sample must be made. It should be noted here that some hormonally active agents only arise when plastics are heated during processing.
The OFI (Austrian Research Institute for Chemistry and Technology) have tested a wide range of different baby and toddler toys from rubber ducks, through plastic building bricks and dolls and finally wooden toys and cuddly animals. The test methods simulated putting the toy in the toddler's mouth and the extract was then tested for hormonally active agents using highly sensitive cell culture tests and chemical trace analysis.
"Although we did observe that the hormonally active softeners phthalates, e.g. diethylhexylphthalate (DEHP), which have fallen into disrepute, are now hardly used at all, we still detected an endocrine effect in some toys", said project leader Dr. Christian Kirchnawy, who investigated the detection of hormonally active agents in plastics in his doctoral thesis. Alongside certain substances now used to replace the softener phthalate, other hormonally active agents were detected in the toys. However, in some samples, the origin of the endocrine activity observed remained unclear.
Mr Kirchnawy added that "It is often very difficult to detect the hormonally active agents since a great many substances are responsible for endocrine effects which were not actively used to produce the toy but got into the product accidentally, for example waste products or by-products of the polymerisation process." He has no time for the perpetually given advice: "Avoid plastic toys," as “in the majority of the plastic samples tested, we did not detect any hormonally active agents, even using the most highly sensitive methods."
And what is more, he continued, the issue of hormonally active agents cannot simply be restricted to plastic toys. Previous OFI tests have shown that apart from toys made of soft PVC, textiles (e.g. cuddly animals) were also affected.
Do manufacturers of toys in which hormonally active agents are detected have to fear legal consequences? At the moment there are no generally valid regulations. There are some bans and thresholds for individual hormonally active agents such as Bisphenol A and phthalates, but as yet there are no general rules as to how to deal with the issue. The only thing that is clearly regulated is that health must not be endangered.
The bans on BPA in packaging and baby products are justified by the endocrine activity and the resulting uncertainty in the toxicological assessment. But this does not enable us to draw any conclusions about how other hormonally active agents will be dealt with in future. Pressure from the public played a decisive role in the BPA bans imposed. There is (as yet) no such pressure in connection with less well-known hormonally active agents.
Environmental and consumer protection organisations vehemently demand general regulation at European level about how to treat "endocrine disruptors", i.e. hormonally active agents that have a harmful effect on humans or the environment. An agreement is still a long way off.
Even in the absence of statutory requirements, more and more manufacturers are testing their toys. The OFI, in close cooperation with industry, has developed and validated appropriate analysis methods to detect hormonally active agents. The OFI experts base their methods on a combination of chemical trace analysis (GC-MS/FID and HPLC-MS³) and biological tests.
The effects of hormones on the human body are simulated on human cells grown in culture vessels. This enables scientists to detect not only the known endocrine disruptors such as Bisphenol A or phthalates, but also previously unknown hormonally active agents. Toy manufacturers can consequently prove that their products are free of hormonally active agents according to state-of-the-art technology. Additional information on packaging also creates greater transparency for the consumer.
Product safety is an important aspect in the toy industry. Make use of the opportunity offered by the Spielwarenmesse® to listen to the advice given by national and international institutes on test methods and safety requirements in the Testing & Inspecting Center.
About the author
Dr. Johannes Mertl, expert on in-vitro analysis at the OFI (Austrian Research Institute for Chemistry and Technology), has developed methods to test food packaging, toys and medical products for hormonally active agents, skin tolerance and allergenic potential. The combination of biological and chemical methods has proven successful in detecting chemical substances as well as biological effects.