We received a note via email from our regular correspondent, Ferdinand Ebgelbeen, a chemical engineer working at plant in Belgium, who is also the spokesman for the Chlorine Chemistry Industry. The indented paragraphs are comments from a PVC opponent; Engelbeen's comments alternate. Bold typeface indicates editor's (E.L.) comments. RETURN TO PVC HOMEPAGE
Subj: Re: OEM: message on PVC toys (fwd) Date: 98-08-29 16:45:17 EDT From: Ferdinand.Engelbeen@ping.be (Ferdinand Engelbeen) To: TurnerToys@aol.com Dear OEM-ers, Some reaction on the continuous story of phthalates...
The Weinberg Group, described in the ENDS report entitled "Scientists criticise EU move to ban phthalates" is a third party consultancy hired by industry to find uncertainties and questions in science regarding product hazards and to keep restrictive action from occurring. This organization is by no means independent and unbiased and their scientific integrity is questionable.
I do not know how questionable the Weinberg Group is, but the scientists they asked to give their opinion in the phthalate question are not: [Prominent among them is Rinus Rijk of the Dutch TNO Food and Nutrition Research Institute, which is leading an international study to develop a reliable method of testing phthalate migration from children's toys to human saliva.] TNO in The Netherlands is one of the most respected research institutes in Europe. The named study is conducted for the consensus group, composed of the Dutch government, the PVC and phthalate producers and the Consumentenbond (Dutch consumers organisation heavily acting against PVC in all its forms!).
Secondly, the efforts being undertaken by companies such as Mattel and Exxon and the U.S. Department of Commerce to influence the European Union scientific process are by no means scientific. Documents obtained from the Department of Commerce demonstrate clear political goals in stopping EU action on phthalates in PVC toys. Nonetheless, there is absolutely no reason to believe that EU action on PVC toys would have any effect on this $22 billion industry. PVC toys make up less than 1% of all plastic toys.
That is not the point. The point is that PVC toys (and medical devices), containing phthalates, are safe or they are not. If they are not safe for their purpose, they must be banned. But no safe product should be banned, based on unscientific and only "political" motives.
PVC toys contain up to 50% by weight phthalate esters.
So do blood bags and other medical devices. There is as far as I know no problem at all, even not for dialysis patients... [See section on Phthalates on the PVC Home Page. Studies referred to cite large daily intake of phthalates by dialysis patients] Crystal glass contains up to 80% lead, that is no problem at all, as long as it doesn't dissolve too much... [Of course, lead content in crystal is a problem; pregnant women should not use such utensils. See section on lead toxicity on Home Page, especially cumulative effects] At any rate, in the public health field we have accepted results of animal testing to be applicable to humans for the past 50 years. Those who do not agree with this are often those who do not like the results of the animal tests. Based on lots of animal tests, all adverse effects of all phthalates tested until now had NOAEL's. The lowest NOAEL's were for peroxisome proliferation. That effect is not at all seen in primates, neither are excess cancer cases, including liver cancer. [Precisely the opposite is true. See section on Phthalates on PVC Home Page.] NOAEL's for other effects, including liver cancer in rats and mice, were orders of magnitude higher. Either one accepts scientific evidence, or one doesn't, but then we are going into purely speculative politics, not science. [See quotation from cited study regarding dosage of phthalates on PVC Home Page.]
These phthalate esters are not chemically bound to the polymer (even the toy and chemical industries do not dispute that) so that they can leach during normal toy use, even moreso when pressure, such as chewing is applied. The amounts of exposure have varied depending on the testing protocol, however, all of the testing protocols to date have demonstrated significant leaching of phthalates.
This is not true. Tests done in Germany for the Government (BGA) and by the TÜV for the toy industry  with the standard protocol, had migrations below TDI's or even below detection limits. So were the governmental tests in Belgium and Italy. All tests in all countries, except in Denmark and The Netherlands, were below TDI (TDI being 100-500 times below the lowest NOAEL in rats). But even the highest level found in one toy (7 of 10 were below TDI) in Denmark, was still 8.8 times below the NOAEL. E.g. for DINP, levels found were from below detection limit (0.16 microg/kg bw/day) up to 1,700 microg/kg bw/day) for the highest in the Danish test . As you can see the test method has definitely a large influence. That means that you need a reliable test that accurately simulates what happens in a child's mouth. That test will be ready within two months. So there is no hurry to take any measure. [We reprint that test in this website - see Dutch Government study attempts to replicate and quantify infant exposure to Phthalates from teething toys
The phthalate esters are the most abundant human made contaminants found in the environment. The U.S. Centers for Disease Control are in the process of initiating a wide spread screening of the U.S. population for phthalate levels (monoesters) as a result of finding high levels of phthalates in blood when testing for DDT (DDE) and PCBs. Even if the phthalates are only weakly toxic, human exposure, especially to infants who are ingesting phthalates in infant formula, could be great.
Daily ingestion of phthalates are partly measured and partly estimated from average food intake . Intake from air, food, water and soil for DEHP (the most abundant man-made phthalate) is app. 10 microg/kg bw/day. Even the highest amount of DEHP found in infant formulae wouldn't give more than 30% of the TDI which is 50 microg/kg bw/day. With that intake, 300 times below the NOAEL for peroxisome proliferation in rats, tenthousands of times below the NOAEL for all other effects, are phthalates still toxic???
Most importantly, there are alternative plastics and other materials such as cloth and wood that can be used to replace PVC in toys. Some of these include polyethylene and ethylene vinyl acetate.
Cloth and wood, nice breeding grounds for bacteria and fungi, have to be treated by nasty chemicals (pentachlorophenol...) to prevent them of being biodegraded. [This is a clearly nonsensical statement! Cloth or wood toys are not treated with preservatives - they are not used outdoors! And, of course, they are washable.] Or you can paint wood (whith phthalate ester [!] based and sometimes lead coloured oilpaints...). Wood (dust) itself is a proven human carcinogen and contains natural chemicals that can leak from that toys which induce sex changes in fish...[Really!! You don't get wood dust from wood toys. And the cancer-causing effects of wood dust are associated ONLY with inhalation over a very long time, a situation occurring almot exclusively in wood-products manufacturing facilities. The carcinogenic nature of wood is not chemical based, as with the substances used in plastics; it is due to the mechanical irritation of the dust collecting in the lungs.] PE needs chemicals against oxydation and sun-ray attack (nonylphenol...). Rubber (recommended by Greenpeace) contains nitrosamines from the manufacturing process (and sometimes phthalates!)... Which one do you like to give to your (grand)children? A few months ago rubber baby soothers had to be withdrawn from the market in Belgium because of too high nitrosamine content. I haven't heard of any action of the EC to withdraw all rubber toys and other child care articles from the market, neither of Greenpeace actions against rubber manufacturers...[These statements are true, and have been overlooked in the present debate on PVC. Most polymer substitutes have additives that will undoubtedly be found to be harmful, when finally they are investigated with the thoroughness with which we have examined PVC.]
These plastics are not only less polluting throughout their production, use and disposal,...
I do challenge you or anybody else to find ONE scientific report to prove this. I am in the posession of more than ten realistic life cycle analyses, not made for the PVC industry, where PVC is compared with alternatives, including PE, PET, wood, steel, glass, aluminium,... for different purposes, where it is always amongst, if not the least polluting material(s) .
Meanwhile children continue to be exposed to phthalates, which could result in possible adverse health effects.
As far as I know, a NOAEL is a NO observed adverse effect level, in this case for rats. That doesn't give a 100% safety for humans. There is still maybe a 1% chance that some adverse effect was not detected. In the case of phthalates the NOAEL gives already a >99.9% safety margin for non-peroxisome endpoints, including oestrogenic, fertility, reproduction, sperm count, carcinogenic, teratogenic,.... effects. The TDI gives a 99.999% probability that NO adverse effects will occur sooner or later. And as far as I know, no adverse effects have been seen in children, including dialysis patients, after more than 40 years of phthalate intake... [Not true! See PVC Home Page] What more proof of safety do you want?
In the case of DINP, this means that a range of toxicological endpoints may have not even been examined yet.
Which one do you miss? And what endpoints have been tested yet for the additives (or ingredients) of "safer" alternatives?
In the case of PVC toys and phthalate exposure, the debate needs to move from one based on acceptable levels of risk or acceptable daily intakes, which is uncertain, contentious, and based on limited knowledge to one based on the availability of safer alternatives, which is much more certain.
What makes you certain that the alternatives are safer? Testing for acceptable daily intake of the migrating ingredients or just belief?
In the end, if this debate over an acceptable exposure level is to continue, the toy industry could take on some responsibility by, at a minimum, labelling their toys - that they contain a potentially toxic chemical that can leach during use.
I could agree with the first point, if that wouldn't be abused by some groups as a stigma to create fears amongst the public, just to reach their target, which has nothing to do with public health. And for the second point, do you label food and warn mothers also for salt, or worse, alcohol before breast feeding, as potentially harmfull to fatal poisons, which they are if taken in huge quantities? [Yes! At least in the U.S., we do just that!] Btw, Greenpeace was reprimanded by the Dutch Advertising Code Council for their advert, calling PVC-toys toxic . Even laymen do see the difference between "toxic" and "maybe" (but probably not) harmfull...
As Alvin Weinberg (no relationship to the other group, I believe) states, these are issues of "trans-science" which must be resolved through public policy.
As you mean by "public policy" political decisions, even these must be based on science, not the politics of the moment. That means that before you switch from a known (extremely low) risk to any alternative with unknown risk, that you should test the alternative as thoroughly as you have done for the first one. I am pretty certain that you will find some unpretty surprises... Sincerely, Ferdinand Engelbeen Chairman Chlorophiles Oude Ertbrandstraat 12 B-2940 Stabroek Belgium Tel.&fax: +32-3-664.46.63 if problems with faxes: call +32-3-664.46.63 - wait for beep - 48. http://www.ping.be/chlorophiles/ Ferdinand.Engelbeen@ping.be References:  ENDS report June 16, 1998.  Untersuchung von PVC-Spielzeugen auf Weichmacher (Investigation of PVC toys on softeners), TÜV Rheinland, 22 December 1997.  Phthalate migration from soft PVC toys and child-care articles, opinion expressed at the CSTEE third plenary meeting, Brussels, 24 April 1998, EU Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE).  See: http://www.ping.be/chlorophiles/Eng/PVCLCAc.html  See: http://www.ping.be/chlorophiles/Eng/ChlorineRCC2.html
RETURN TO PVC HOMEPAGE