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Thermoplastics > Polycarbonate > e-books

THE POLYMER BOOKSHOP®
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Engineering plastics news PC Applications

Two titles in this webpage:
1-Polycarbonate. e-book
2-BPA Polycarbonate. The health issues.

Polycarbonate
From chemistry to marketing
ISBN 9078546026

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The "Advanced course" version (ISBN:9789078546092), which does not include a patent survey, costs 55.
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For information contact Deny Kyriacos, President & CEO, GEM-Chem.
e-mail: dk@GEM-Chem.net, phone: +32-2-7710649

Dr.Kyriacos has worked at Upjohn (Polyurethanes), GE (Engineering thermoplastics) and
ICI (Polyurethanes) in international TS, Sales and Marketing.
He holds a B.Sc.(Distinction, Honours, University award in Chemistry) from Alexandria,
a M.Sc.course,(ICI scholarship award) in Polymer Technology and, a Ph.D. from
Loughborough in the UK.
Deny Kyriacos is the founder of DK Business Group and GEM-Chem.

Deny Kyriacos: LinkedIn profile

GEM-Chem compose and publish e-books and data bases
on Polymer Science, Engineering, Technology and Marketing
GEM-Chem initiate, develop, market and direct new projects on company
organisation, international marketing, engineering, technology and science


BISPHENOL A POLYCARBONATE.
The story of the health issue from 1995 until 2015.

An ongoing health issue is related to the liberation of bisphenol A (BPA) and eventually CO2 from BPA-polycarbonate subjected to hot water treatment.
BPA is suspected to have estrogenic (hormone disrupting) properties.
Animal studies suggest that BPA might enhance the susceptibility of individuals in developing certain cancers.
During development, exposure to estrogens may also disrupt the normal growth and function of reproductive tissues as well as the brain.
Scientists at the University of Missouri-Columbia have reported that the prostates of some mice exposed to 2 ppb (parts per billion) BPA were larger than normal, though no cancers were detected.

The estimated dietary intake of BPA from polycarbonate is less than 0.0000125mg per kilogram body weight per day.
This level is more than 4000 times lower than the maximum acceptable quantity of 0.05mg BPA per kilogram body weight per day as, initially established by the U.S. Environmental Protection Agency (Ref: www.bisphenol-a.org)
Babies' BPA intake from polycarbonate bottles is set at 0.035 mg/day for a 1 to 2 month old baby and 0.05mg day for a 4 to 6 month old baby.

Early tests on the migration of BPA from baby bottles failed to detect traces of the chemical [Ref: Mountfort, K.A. et al., (1997), Food Addit Contam,14(6-7),737-40].
It has been shown, later, that BPA, indeed migrates from polycarbonate cups in contact with boiling water [Kawamura, Y. et al.(2001)Shokuhin Eiseigaku Zasshi, 42(1), 13-7].
Toxicologists of the Prefectural University of Kumamoto, Japan, (Ref: K. Arizono. 1999. Journal of Health Science 45:39) tested 10 different brands of polycarbonate baby bottles from the US, Germany, Japan, Korea, Malaysia, and the Philippines.
The test consisted in putting the polycarbonate materials in contact with hot water (90C) for 30 minutes and then measuring how much BPA was extracted.
Brand new baby bottles, lost between 1 and 3.5 ppb, BPA. Used but relatively clear bottles lost as much as 6.5 ppb. Very worn and heavily scratched bottles leached between 10 and 28 ppb of BPA.
Tests carried out in 2002, indicated that the migration of BPA from polycarbonate remained undetectable when polycarbonate packaging is in contact with water, fruit juices and baby food.

According to EU directives (2002/72) the minimum allowed migration of BPA is 0.6mg/Kg [Ref:European Commission, Scientific Committee on Food (2002) Opinion of the Scientific Committee on Food on Bisphenol A. SCF/CS/PM/3936 Final, 3 May 2002]
Tests carried out by the UK Food Standards Agency in 2003 indicated that the migration of BPA from polycarbonate in contact with different foodstuff did not exceed 0.029mg/Kg.
The migration of BPA from tableware made from polycarbonate was set at 50µg/Kg.

In 2003, the European Chemicals Bureau [European Chemicals Bureau (2003) European Risk Assessment Report of Bisphenol A. Volume 37] declared that the information available on the migration of BPA from polycarbonate packaging to food was not conclusive.
According to experimental work carried out by the Consumer and Food Product authority in 2005 (Report no. ND050410) all new and used baby bottles were analysed for the migration of BPA according to European standard EN 14350-2.
In nearly all tested baby bottles no migration of BPA was detected in distilled water nor in 3% aq. acetic acid solution.
From all tested samples, only 4 used baby bottles showed traces of migration of BPA in distilled water (below 0.0050 mg/L). These migrations were far below the Dutch specific migration limit(SML) of BPA of 3 mg/kg (planned to become 0.6 mg/kg). They are also ten times lower than the SML of the European standard of 0.03 mg/kg.

Additional data are provided by the following experiments. Eighteen different brands of polycarbonate baby bottles sold in Europe were collected. Migration of BPA was determined by placing a polycarbonate bottle filled with water in a microwave oven and heating to 100C. The level of BPA in the water was then determined by gas chromatography/mass spectrometry. Migration of BPA into water ranged from less than 0.1 to 0.7 µg/l. The data show that during three microwave-heating cycles of a baby bottle made from polycarbonate, microwave radiation had no effect on the migration of BPA in water.
All levels found were well below the SML of 0.6 mg/kg specified for BPA in the European Commission Directive 2004/19/EC. [Ref: Ehlert, K. A. et al., Food Additives & Contaminants, Part A: Chemistry, Analysis, Control, Exposure & Risk Assessment (2008), 25(7), 904-910]
A BPA migration study at 70C on polycarbonate baby and reusable water bottles sold in Canada was carried out using isotope dilution, solid phase micro-extraction and gas chromatography/mass spectrometry. The test, which used whole bottles instead of pieces cut from bottles, showed that BPA migration from PC bottles heated at 70C increased over time. BPA migration levels in water were 228-521 micrograms/l [Ref: Cao, Xu-Liang et al.,Journal of Agricultural and Food Chemistry (2008), 56(15), 6378-6381]. Finally, alkali washing solutions at concentrations similar to those used in dishwashers contained BPA in concentrations just above 100 µg/l. [Ref: Biedermann-Brem, Sandra et al.,European Food Research and Technology (2008), 227(4), 1053-1060].

In 2008 the government of Canada enacted legislation to ban the import, sale and advertising of polycarbonate baby bottles (Ref: www.chemicalsubstanceschimiques.gc.ca)
The FDA pointed out that the action was taken "out of an abundance of caution," and that Canadian scientists haven't found any proof of harm to babies with typical exposure to bisphenol A.
However, an independent subcommittee reviewed the FDA draft report, at the FDA's request, and posted the following criticisms:
1-Some studies were excluded without enough explanation.
2-Uncertainty in bisphenol A research wasn't mentioned enough.
3-The FDA's margins of safety for bisphenol A are inadequate.
4-More attention should have been paid to infants' exposure to bisphenol A.

In May 2008, Minnesota banned the use of bisphenol A in baby bottles and sippy cups.
The state joined Suffolk County, N.Y., which earlier in the year enacted a similar ban.
Other bans have been proposed in Connecticut, Michigan, New York, California, Chicago and Schenectady County, N.Y
In August 2009, and, after examining several studies carried out on animals, the Department of Public Health (DPH, www.mass.gov/dph) in the US state of Massachusetts has warned parents not to use products containing BPA for either infant formula or milk. The Massachusetts action followed passage of the new US food safety bill, which called on the Food and Drug Administration to complete its review of BPA by the end of 2009.

In October 2009, the German environmentalist group BUND called for a ban on BPA in products for children. BUND and its Austrian partner Global 2000 said their tests found BPA in the nipples of baby bottles, with concentrations as high as 100-2300 mg/kg, in the shields of the bottles. BUND assumed that BPA had migrated from the PC shield into the rubber nipple.

In November 2009 the US National Institutes of Health (NIH, www.nih.gov) spent 30 million USD on tests spanning over two years to determine the effects of BPA exposure on human behaviour, obesity, diabetes, reproductive disorders, asthma, cardiovascular diseases and various cancers.
Another BPA study, on rats, completed on November 2009 by the US Environmental Protection Agency (EPA, www.epa.gov) found no adverse effects on the endocrine system from low exposure to the chemical.
In December 2009, The British Plastics Federation (BPF) has reassured members of the public on the safety of Bisphenol-A (BPA) following the launch of a campaign by Breast Cancer UK to ban the use of BPA in baby bottles.
In January 2010, researchers from the Peninsula Medical School and the University of Exeter, UK, have reported evidence on a link between Bisphenol A exposure and cardiovascular disease.
However the story does not stop here.
On January 15, 2010, the FDA changed its view that BPA is safe in food-contact applications at its current levels. The FDA said that it was "taking reasonable steps to reduce human exposure to BPA in the food supply" because some studies have raised concerns "about the potential effects of BPA on the brain, behavior, and prostate gland in fetuses, infants, and young children."
By mid February 2010, a study by the Organisation for Economic Co-operation and Development (OECD) concluded that Bisphenol A has no effect on the nervous system (Ref: Journal of Toxicological Sciences)
In March 2010, the government of Canada has prohibited the use of BPA-polycarbonate baby bottles.(Ref: Canada Gazette Part II, Mar. 2010)
In May 2010 a ban on manufacturing, importing, exporting and selling "baby bottles made of BPA-based products" has been approved in France by a majority of deputies in the assembly
. A few days later Vermont has become the sixth state - and fourth in 2010 - to pass a ban on the use of bisphenol A in baby bottles and 'sippy' cups used by young children
In August 2010 Canada has added BPA to its register of toxic substances, making it the first country in the world to establish the ban countrywide. The decision follows research that showed that 91% of Canadians had BPA in their urine
In October 2010, an EFSA (European Food and Safety Authority) research, initiated by the European Commission, concluded that "they could not identify any new evidence which would lead them to revise the current Tolerable Daily Intake for BPA of 0.05 mg/kg body weight set by EFSA in its 2006 opinion and re-confirmed in its 2008 opinion
However, in November 2010, an American study of more than 200 Chinese factory workers has found a link between plastic feedstock BPA in urine and potential reproduction problems such as decreased sperm vitality and count.
A European ban on baby bottles containing BPA has been imposed by the European Commissions from June 2011 over fears that BPA could harm the immune system of infants.
By the end of May 2011 the Chinese Ministry of Health issued a health notice banning the manufacture of bottles containing BPA. In addition, starting 1 September, imports of bottles containing BPA were prohibited.
Delaware has become the ninth state to enact a ban on baby bottles that contain bisphenol A. The ban which went into effect in July 1, 2012 applies to all bottles and cups that can be filled with food or liquids and are intended for use by children under the age 4.
In October 2012, the French Senate adopted a law that bans the use of bisphenol A in food contact packaging, effective January 1, 2015.
And the story continues.
In April 2013, the environmental agency of California has added BPA to its official list of toxic chemicals.
A study carried out at Stanford University in October 2013 has shown that BPA exposure dramatically increases the risk of pregnant women suffering a miscarriage.
In June 2014, the European Commission has decided to set a migration limit of 0.1 mg/l in toys for children up to the age of 3 years and in any toys intended to be placed in the mouth. The limit was taken from European Standard EN 71-9:2005+A1:2007, which is implemented by the European toy industry to control the content of BPA in toys.
The European Food Safety Authority (EFSA) has proposed a lower tolerable daily intake (TDI) for BPA. The TDI for BPA is currently 0.05 mg/kg/bw/day, which EFSA is now proposing to reduce to 0.005 mg/kg/bw/day (bw = body weight) Astonishingly, in January 2015, the European Food Safety Authority (EFSA) has concluded that there is no health risk to consumers of any age group from current exposure levels to BPA after it completed a comprehensive evaluation of current data.
And, even more, in September 2015, the French Constitutional Council has ruled it was unconstitutional for the nation to ban the manufacture and export of BPA-based food contact materials out of France.
Conclusions
Since the introduction of BPA-polycarbonate baby bottles in the market, millions of humans have probably been repeatedly fed in the early stages of their lives with milk which was in contact with polycarbonate.
To my knowledge there is no study on the effect this has had on them developing BPA induced cancers.
In any event most basic experiments suggest that BPA migrates from BPA-polycarbonate to boiling water. Furthermore, the probability of BPA affecting negatively one's health, even if infinitesimal, cannot be disregarded. As a result serious concerns have risen on the contamination of food or water which came into contact with BPA-PC
Advantage has been taken of these concerns for developing plastics alternatives to polycarbonate bottles which eventually have been marketed, loudly and clearly as being......... BPA free.


For information contact Deny Kyriacos, President & CEO, GEM-Chem,
E-mail: dk@GEM-Chem.net, phone: +32-2-7710649

Dr.Kyriacos has worked at Upjohn, GE and ICI in international TS, Sales and Marketing.
He holds a B.Sc.(Distinction, Honours, University award in Chemistry) from Alexandria,
a M.Sc.course,(ICI scholarship award) in Polymer Technology and, a Ph.D. from
Loughborough in the UK.
Deny Kyriacos is the founder of DK Business Group and GEM-Chem.

Deny Kyriacos: LinkedIn profile

GEM-Chem compose and publish e-books and data bases
on Polymer Science, Engineering, Technology and Marketing
GEM-Chem initiate, develop, market and direct new projects on company
organisation, international marketing, engineering, technology and science

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