Polycarbonate Resin&
Bisphenol A

Q&A
June 2003(Published)
January 2010 (Revised)

Polycarbonate Resin Manufacturing Group

This is a translation of the Japanese “Q&A”.

Introduction

The Polycarbonate Resin Manufacturers Group (PCMG) provides information on Environmental
Endocrine Disruptors (environmental hormones) on its website and pamphlets etc. This information isprovided to reassure our clients and consumers that polycarbonates are safe to use.
The PCMG is making every possible effort to distribute the most up to date information by exchanging
data with associated researchers and the mass media. The PCMG is also collecting any relevant informationfrom experiments and their resulting scientific data.

Environmental Endocrine Disrupter issues related to polycarbonate resin are not concerning the resin
itself but one of its constituents, namely bisphenol A. A Japanese translation of “Our Stolen Future”, a bookabout the endocrine disrupter effects of bisphenol A, was published in 1997. This publication caused great
concern among users and consumers of polycarbonates around 1998. Disquiet has largely subsided sincesafety information about polycarbonates has become publicly available.

The PCMG also organized the “PC/BPA Global Team” together with major polycarbonate resin andbisphenol A manufacturers in Europe, America and Japan. The group has been carrying out a number ofscientific tests and studies to obtain relevant safety data in order to better understand any effects ofbisphenol A.

It is to address any concerns about the safety of polycarbonates that we have produced this Q & A
brochure.

Polycarbonate Resin Manufacturers Group2

IndexPage
1. Polycarbonate resin and polycarbonate products:
Q1-1
Q1-2
Q1-3
Q1-4
Q1-5
Q1-6

Which companies manufacture polycarbonate resin? ………………………………………. 5
What is the production volume of polycarbonate resin? …………………………………. 6
What is the forecast of demand in the future?
What are the features of polycarbonate resin? …………………………………………… 7
What applications are polycarbonates used for?
How is polycarbonate produced? …………………………………………………………. 8
How are polycarbonate resin pellets for molding and extrusion produced? ……………… 9
How are polycarbonate products produced? ……………………………………………... 10

2. The relationship between polycarbonate resin and bisphenol A
Q2-1 Why does bisphenol A remain in polycarbonate products? ……………………………….. 11
Q2-2 Does bisphenol A increase during the production process of polycarbonate products? ….. 12
Q2-3 What methods are used to measure bisphenol A remaining in polycarbonate resin? …….. 13
Q2-4 What does “migration of bisphenol A from polycarbonate products” mean? ……………. 14
Q2-5 What methods are used to measure the amount of bisphenol A that migrates …………… 15
from polycarbonate products? How accurate and sensitive in the test?
Q2-6 How are the standards for polycarbonate used for food contact applications decided? …. 16
Q2-7 How much bisphenol A is migrated from polycarbonate products? ……………………… 18
Q2-8 Why is the migration amount of bisphenol A from polycarbonate products small? ……... 20
Q2-9 What kind of practices/methods have been employed when producing polycarbonate ….. 21
resin for food contact applications?
Q2-10 Does polycarbonate resin decompose and generate bisphenol A during use of ………….. 22
polycarbonate products?
Q2-11 Is bisphenol A migrated when food in a polycarbonate container is microwaved? ………. 23
3. About Bisphenol A
Q3-1
Q3-2
Q3-3
Q3-4
Q3-5
Q3-6
Q3-7
Q3-8
Q3-9

What is bisphenol A? ……………………………………………………………………... 25
I heard that even trace amounts of environmental hormones are hazardous. …………… 26
Is bisphenol A also hazardous?
How safe is bisphenol A? ………………………………………………………………… 30
What is the low-dose issue of bisphenol A? ……………………………………………… 32
What are the recent test results on the low-dose toxicity effects of bisphenol A? ……….. 34
We understand that the allowable intake level of bisphenol A is being reviewed ……….. 37
in Europe; how is it being treated in Japan?
How does bisphenol A accumulate? ……………………………………………………… 38
What is the biodegradability of bisphenol A? ……………………………………………. 39
The effects of bisphenol A on the cerebral nerve and immune system of ……………….. 40
fetuses/newborns have recently been reported; are these reports reliable?

34. Compliance of polycarbonate resin and its products with environmental conditions related tobisphenol A
Q4-1
Q4-2
Q4-3

Is bisphenol A discharged into the environment during the manufacturing process ……. 41of polycarbonate or the molding process of products?
Are there any precautions required for the disposal of polycarbonate products? ………. 42
It was reported that bisphenol A was detected in the rivers nearby plastic waste ……….. 43
disposal sites; is this attributable to polycarbonate products disposal?

5. The safety of polycarbonate products and response by polycarbonate manufacturers
Q5-1
Q5-2
Q5-3
Q5-4

In Europe and America, polycarbonate is being used for returnable milk bottles and ……….
water bottles. What are consumer reactions?
What do you think about the safety of polycarbonate tableware and baby bottles? …………
How are polycarbonate manufacturers coping with the environmental hormones …………
issue of bisphenol A in Japan?
How are you cooperating with overseas polycarbonate and bisphenol A manufacturers …….
in relation to the environmental hormone issue?

46
47
49
50

4

Which companies manufacture polycarbonate?

In Japan, the following six companies conduct the manufacturing, compounding and sales ofpolycarbonate plastics.
These companies, is the world's leading with a superior technology in manufacturing, quality
control and safety management.

Polycarbonate Companies in Japan
Idemitsu Kosan Co., Ltd.
● Sumika Styron Polycarbonate Ltd.
● Teijin Ltd.
● Mitsubishi Engineering-Plastics Corp.
● SABIC Japan LLC (Compounding)● Covestro Japan Ltd. (Compounding)●

Polycarbonate resin was developed in 1956 by Bayer in Germany. Later, companies in Europe, America
and those in Japan developed their own production technologies and began manufacturing polycarbonates.
The six Japanese polycarbonate resin manufacturers have organized the Polycarbonate Resin Manufacturers
Group to pursue the supply of high quality products. The group has been making efforts to improve their
quality control technologies and is solving the endocrine disrupter issue by conducting various tests andcollecting and releasing relevant information. In addition, the group is working closely with polycarbonate
resin manufacturers, bisphenol A manufacturers and related chemical industry associations in Europe andAmerica.

5What is the production volume of polycarbonate resin?
What is the forecast of demand in the future?

Global production volume of polycarbonate resin in 2001 was estimated at about 2.2 million
tons. Japan produced about 0.36 million tons and America, Europe and Asia excluding Japanproduced about 0.69, 0.78, 0.33 million tons, respectively.
Since polycarbonate has been used in various applications including electronics, OA
apparatus, automotive parts and building materials, medical equipment, daily necessities,
etc., its production ratio is increasing at an annual rate of more than 10%. It is expected to
grow further in the future.

Polycarbonate resin is one of the “5 major engineering
plastics.” These 5 plastics play an essential role invarious areas of our life, and the demand forpolycarbonate in particular is rapidly increasing. The
unique features and safety of this resin contribute to anincrease in global consumption. Thus, there are plans
to establish new plants and expand existing plants in
Asia.

Production
Volume(1,000t)(Table 1) Major Engineering Plastics’ Production in Japan (1990-2001)
PC
Polycarbonate
POM
Polyacetal
Polybutyleneterephthalate
PBTPA
Polyamide
m-PPE
Modified Polyphenyleneether

5 Major Engineering Plastics include Polycarbonate, Polyamide, Polyacetal, Modified PPE(Polyphenyleneether) and PBT (Polybutyleneterephthalate).
As engineering plastics have high mechanical strength, high physical strength and high heat resistance,these have been widely used for applications like automotive parts, machinery parts, andelectrical/electronic parts.

6

What are the features of polycarbonate resin? What applications arepolycarbonates used for?

Polycarbonate resin has very useful properties such as high impact resistance; high heat
resistance; weather resistance; high transparency; high gloss; and it is non-flammable. In
addition, Polycarbonate has excellent electrical properties and is safe and hygienic.

Polycarbonate resin is widely used in various industries and fields. Applications include CDs; opticalfibers; electric appliances; cameras; cellular phones; OQ equipment; electronics; optical equipment;
medical equipment; automobiles; goggles; baby bottles; school tableware; dome roofing (as a sheet); andwindows (replacing glass).

Properties and Applications of Polycarbonate
Transparent, Break ResistantProtective eyeglasses, sunglasses,
goggles, windows, automobile
lamp lenses, etc.
Transparent, Break Resistant,
Distortion ResistantCDs, CD-ROMs, MDs, etc.
Transparent, Lightweight, BreakResistant, Heat ResistantIron water tank, street lamp covers,
electric light covers, arcades,
garage roof, etc.

High Performance

Lightweight, Break ResistantHelmets, Automobile door handles, etc.

Lightweight, Heat Resistant,
Non-Flammable, Distortion ResistantPCs, cellular phone cases, camera parts,
watch parts, MD cases, etc.
Lightweight, Safe/Hygienic
Baby bottles, tableware,reusable water bottles, etc.

Polycarbonate Product• Transparent• Break ResistantProtective eyeglasses

7How is polycarbonate produced?

There are two polycarbonate manufacturing methods, the Solvent Method and the Melt
Method (Ester Interchange Method). The Solvent Method produces polycarbonate frombisphenol A and carbonyl dichloride, while the Melting Method produces polycarbonate frombisphenol A and diphenyl carbonate. The polycarbonates produced by both methods have
similar structures.

Synthesis by Solvent Method

Bisphenol A

Caustic Soda

Polycarbonate
Carbonyl Dichloride

Non-reacted bisphenol A and other by-products are removed in the separating and purifying stages of thesynthetic process. Non-reacted carbonyl chloride does not remain in the resin as it is removed after 100%
decomposition through reaction with caustic soda.
Synthesis by Melting Method

Bisphenol A

Diphenyl Carbonate

Remove Phenol

Polycarbonate

Non-reacted bisphenol A,diphenyl carbonate and the phenol of by-products, etc. are removed by deaerationin the molten polymerization stage.
Chemical name and chemical information on polycarbonate.
• Chemical name:• Official gazette serial number:• CAS No.:

poly-4, 4’isopropylidene-diphenyl carbonate
CDIL-SSL(7)-738
80-05-7

8

How are polycarbonate resin pellets for molding and extrusion produced?

Additives and coloring agentg are added to polycarbonate resin (base polymer), synthesized
by the methods described in Q1-4, before particle-shaped molding materials, called pellets,
are made by melt-extrusion using an extruder.

An outline of the equipment for making
pellets is shown below.
The base polymer is mixed with additives,and coloring agents, then melted andextruded in a string-shape and cut into
particle-shapes called pellets using apelletizer. As shown in the photograph, thepellet is cylindrical, about 3 mm in diameterand about 3 mm in length.

Pellet Making Process
Polycarbonate resin (base polymer)
Additives
Coloring agentsweighing

MixingExtruding (pelletizer)

Mixed polycarbonate
Hopper
ExtruderDie

Pellets

Packaging (paperbag, etc.)

CutterPelletPellets

Cooling
Polycarbonate resinmaterial

9How are polycarbonate products produced?

Polycarbonate resin, in the form of pellets, is melted at a high temperature (280°C–300°C),
then injection-molded to make everyday products and industrial goods and parts. For
making sheets and films an extruder is used. Bottles are made by blow molding.

Injection Molding (Typical Molding Method):
Polycarbonate is a thermoplastic resin, which is asolid at normal temperatures, but melts at hightemperatures and solidifies at low temperatures. Molders
melt pellets at a high temperature before the sameamount as that of the weighed product is poured into amold under high pressure, then cooled and removed
from the mold. (Fig. 1 & 2)

Dry pellets
Melted at a high temperature (280-300°C)
Weighed, the amount needed to make the product
Poured into a mold under high pressure

Polycarbonate (Pellets)
Mold

Cooled (around 80°C)-solidified
Removed from the moldScrew

(Fig. 2)
Production Process of Polycarbonate Products

Product(Fig. 1)
Injection Molding

High Performance

Polycarbonate Product• Transparent• Break Resistant• Distortion Resistant
CD, CD-ROM

10

Why does bisphenol A remain in polycarbonate products?

In the polycarbonate production process, there is a stage to remove non-reacted bisphenol A
and other non-reacted substances, but they cannot be removed completely. That is why trace
amounts of bisphenol A remain in polycarbonate products.

In the process of polycarbonate production, for example, in the solvent method, it is necessary for bisphenol
A molecules to be brought into contact with carbonyl dichloride molecules. Immediately after the reaction
starts, the reaction of the bisphenol A and carbonyl dichloride proceeds rapidly. However, as the reaction
proceeds, the increasing presence of polycarbonate polymers reduces the frequency of bisphenol A andcarbonyl dichloride reactions. The reaction is accordingly slowed and finally stops. Therefore some trace
amounts of non-reacted bisphenol A and carbonyl dichloride remain in the polycarbonate.

BPA(Bisphenol A)

Carbonyl
Dichloride

Polycarbonate Resin

Non-Reacted
BPA(Fig. 3)
Molecular reaction during polycarbonate resin production process11

Does bisphenol A increase during the molding process of polycarbonate
products?

During the molding process of polycarbonate, bisphenol A may be generated when
decomposition occurs under temperatures higher than normal processing temperatures. It has
been confirmed in some cases that decomposition is enhanced by a formulating ingredientused in the processing stage. In other words, it may be possible that bisphenol A is generated
due to the decomposition of polycarbonate when something goes wrong in the processing
stage

The decomposition that may occur during the molding process is attributable to the following.
1) The moisture content in the polycarbonate resin is too high.
2) The temperature for the molding process is too high and/or the dwell time is too long.
3) Additives or coloring agents, or other compounding agents that may enhance decomposition are used.

To prevent decomposition in the molding stage, molding companies take the following
countermeasures.
1) Polycarbonate is preliminarily dried before molding so that the moisture in the material can be removed.
2) Appropriate processing temperatures are advised by polycarbonate manufacturers.
Processors set appropriate processing temperatures for each product based on the advice and carefully
manage production.
3) Polycarbonate manufacturers conduct preliminary tests so that only additives, coloring agents, etc. that
do not enhance decomposition are used. The Polycarbonate Resin Manufacturers Group provides
information for selecting proper additives, coloring agents, etc. as guidelines for processors who
independently add those agents.
High quality products are supplied by fully coping with the above circumstances when manufacturing
polycarbonate products. Naturally, there is no decomposition when polycarbonate products are handled
under normal conditions.

12What methods are used to measure the bisphenol A remaining in polycarbonate
resin?

Normally, measurement is performed by the method specified in Notification No. 370
issued by the Ministry of Health and Welfare (MHW). Basically, bisphenol A is separated
from polycarbonate resin, and this bisphenol A is measured using an analytical method
known as high-speed liquid chromatography. Measurement is expressed in units* of ppm
and ppb.

The measurement method (material quality tests) specified by Notification No. 370 issued by the MHW is
as follows. (Note: The name of MHW was changed to MHLW (Ministry of Health, Labor and Welfare)
1)
2)
3)
4)

Melt polycarbonate product in a specified amount of dichloromethane.
Instill the melted polycarbonate in acetone solvent to extract polycarbonate (polymer)
Separate polycarbonate (polymer) by centrifugal separator
Measure the amount of bisphenol A melted in acetone by high-speedliquid chromatography.

* Units: ppm: parts per million ( =1g in 1 ton)
ppb: parts per billion (=1g in 1000 tons)

High Performance

Polycarbonate Product• Transparent• Lightweight• Break Resistant• Heat ResistantIron Water Tank

• Lightweight• Break ResistantHelmets

13

What does “migration of bisphenol A from polycarbonate products” mean?

It means that a trace amount of bisphenol A that exists near the surface of a polycarbonate
container shifts to the contents, such as water, that is in contact with the product.
Since bisphenol A shifts into the contents, the word “migration” is used.

The following shows 3 ways that bisphenol A migration from a polycarbonate product may occur.
1) Bisphenol A that remains close to the surface of a polycarbonate resin and migrates (see Q2-7 and Q2-8).
2) When polycarbonate product is in contact with alkali and/or heated water, the polycarbonate at thesurface of the product decomposes (hydrolyzes), and thereby releases bisphenol A that migrates. Thisphenomenon varies, depending on temperature, time, etc. (see Q2-10).
3) When both 1) and 2) occur.

High Performance

Polycarbonate Product• Lightweight• High Heat Resistant• Distortion Resistant• Non-Flammable
Note PC Housing• Lightweight• Break Resistant
Automobile Door Handles

14

What methods are used to measure the amount of bisphenol A that migrates
from polycarbonate products? How accurate and sensitive in the test?

Measurement is performed by the test method specified in Notification No.370 issued by the
MHW (See Q2-3). The test method makes it possible to measure up to 0.5 ppm. There arecases where test measurements were able to detect up to 0.5-0.01 ppb under more stringent
conditions.

According to the test method specified by Notification No. 370（1959）and No. 18 (1994) issued by the
MHW, a polycarbonate product is immersed in the pseudo solvent shown in the table and allowed to migratebisphenol A under the conditions shown in the table before the bisphenol A migrated is calculated byhigh-speed liquid chromatography.
(Table 2)

Test
Material

Migration

BPA Migration Tests and Regulation
Ministry of Health and Welfare Notice No.18 (January, 1994) – Individual Standard forApparatus and Container/Wrapping made of Polycarbonate Resin
Compounds

Solvent

Condition

Cd and Pb
Heavy metals

Dichloromethane
4% acetic acidKMnO4 Consumption

Water

AminesDiphenylcarbonate
BPA(include
phenoland p-t-butyl phenol)
Evaporated residues

DichloromethaneRT
60℃ x 30min.
95℃ x 30min
60℃ x 30min.
95℃ x 30min
RT

Regulation (ppm)
Use at <100℃
Use at >100℃
< 100
< 100
<1
−
< 1
−
< 10
−
< 10
−
<1
< 1
< 500
< 500
< 500
< 500

25℃ x 60min.
60℃ x 30min.
60℃ x 30min.
95℃ x 30min
60℃ x 30min.
95℃ x 30min
60℃ x 30min.
95℃ x 30min
25℃ x 60min.
60℃ x 30min.
60℃ x 30min.
95℃ x 30min
60℃ x 30min.
95℃ x 30min

< 30
< 30
< 30
−
< 30
−
< 30
−
< 2.5
< 2.5
< 2.5
−
< 2.5
−

n-heptane
20% ethanol
Water
4% acetic acidKMnO4 Consumption

Water

BPA (include phenol
and p-t-butyl phenol)

n-heptane
20% ethanol
Water
4% acetic acid

< 30
< 30
−
< 30
−
< 30
−
< 10
−
−
−
< 2.5
−
< 2.5

15

How are the standards for polycarbonate resin used for food contact
applications decided?
The specification standard for plastics is regulated in accordance with the Food
Hygiene Law. Bisphenol A contained in polycarbonate products is specified to be
not more than 500 ppm in the material quality test standard and not more than 2.5
ppm in the migration test standard. The Polycarbonate Resin Manufacturers Group
independently established a self-standard for material quality test, that is not morethan 250 ppm.
Note) Material quality test standard: See Q2-3
Migration test standard: See Q2-5

Since it is not possible to establish a migration test standard from experiments on human beings, data on
daily intake not affecting long-term health (No Observed Effect Level) has been obtained from animal
experiments. Safety levels have been extrapolated from such data by converting figures for animals into
humans in view of safety, and 1/1000 of the figure thus obtained is treated as a safety coefficient.
The migration test standard of bisphenol A is common worldwide, but the Japanese standard is the strictest
level in the world, since Japan specifies the material quality standard in particular.
(Table 3) Comparison of Allowable Standards of Bisphenol A among the EU, U.S. and Japan
Standards of Bisphenol A
Material quality test
Migration test
EU
None
Migration standard: Allowable concentration, 3 mg/kg(EC instruction) (TDI*: 0.05 mg/kg/day)
U.S.

None

Migration standard: None
(TDI: 0.05 mg/kg/day)Japan

Not more than 500 ppm Migration standard: Not more than 2.5 ppm(TDI: 0.05 mg/kg/day)*TDI = Tolerable Daily Intake
High Performance

Polycarbonate Product• Lightweight• Safe/Hygienic

School Lunch Tableware

16

The regulation on bisphenol A migration is determined by the following method.
• No observed adverse effect level (NOAEL) in animal test: 50mg/kg/day- Test results in the U.S. and EU.
No adverse effect observed over a lifetime even with 50 mg bisphenol A per 1kg bodyweight per day.
• Conversion coefficient (safety coefficient) from animals to humans: 1/1,000- Normal safety coefficient is 1/100, but the U.S. Environmental Protection Agency (EPA)
set the stricter 1/1,000 coefficient.
• Human permissible intake per 1kg body weight per day (TDI):(50mg/kg/day)x(1/1,000)=0.05mg/kg/day<Bisphenol A migration regulation applies 1/1,000 of the amount for which safety was confirmed
in animal tests>

Daily maximum NOAEL inanimal test
50 mg (per 1 kg body weight)

Safetycoefficient

Human daily permissible
intake is 0.05 mg (per 1 kg
body weight)
If a person weighs 50 kg,
0.05 x 50 = 2.5 mg
When 2.5 mg is converted
into a concentration, it
becomes 2.5ppm. (When aperson eats 1 kg food/day
which was in contact withpolycarbonate tableware, etc.)• Permissible Bisphenol A intake for Japanese people (TDI): 2.5 mg/day(0.05 mg/kg/day) x 50 kg = 2.5 mg/day → Bisphenol A intake which has no adverse effect on an average
Japanese person even when ingested daily over a lifetime.
• Amount of food eaten a day which is in contact with polycarbonate tableware, etc: 1 kg
(Although according to statistical data, Japanese people eat 700g of food a day which is in contact withplastics. This was assumed to be 1kg and that all plastics in contact with foods are polycarbonate.)
2.5 mg/1 kg (1,000,000 mg) = 2.5 ppm (2.5 parts per million)→ Permissible Bisphenol A concentration in food when a person who weighs 50 kg eats 1 kg offood in contact with polycarbonate tableware in a day.
→ Migration test standard
In the U.S. and the EU, there are no material quality test regulations. In Japan, the MHW (current Ministryof Health, Labor and Welfare) established limits on bisphenol A at below 500ppm in order to ensure further
safety margins. This limit was established by their analysis and experimentation on products in the market.

17

How much bisphenol A is migrated from polycarbonate products?

Not more than 5–6 ppb under normal conditions.
Not more than 30–50 ppb when extreme conditions are present.

In view of the data so far confirmed, the amount of bisphenol A migrated from polycarbonate tableware andbaby bottles is approximately 5.5 ppb at most. According to the test results carried out by Yokohama
National University, there were 5.5 ppb of bisphenol A detected from polycarbonate baby bottles filled with
95˚C water and allowed to stand overnight, but there was no bisphenol A found in the same tests using waterof normal temperature.
(Table 4-1) Test Results of Bisphenol A Migration from Polycarbonate Products
Product

Research InstituteYokohama National Univ. (2)Baby Bottle

FDA (3)
British Ministry ofAgriculture, Fisheries andFood (4)National Institute of Health
Science (5)National Institute of Health
Science (5 specimens) (5)Saitama Prefecture(50 specimens each) (6)Tableware
Yokohama City
(5 specimens each) (7)Water Bottle

FDA (3)Returnable
BottleReturnable Bottle Assoc. (8)Test Condition
hot water 95°C,
left overnightwater 26°C,
left for 5 hrs
practical trial condition
milk, fruits juice,micro waved for 30sec.
hot water 95°C x 30min.
20% ethanol
60°C x 30 min.
hot water 95°C,
20% ethanoln-heptanes
hot water 95°C,
20% ethanol
4% acetic acidSee Q2-5, Table 2
water 80°C,
left for 30 min.
soup 80°C,
left for 30 min.
Olive oil 60°C,
left for 30 min.
immersed in water for 39
weeks
Alkali washing 15 times
See Q2-5, Table 2
Used over 100°C

Migration Amount

Detection Limit

3.1 ~ 5.5 ppb
0.2 ppb
Not detected
Not detected

2 ppb

Not detected

30 ppb

0.5 ppb
Not detected
Not detected ~ 5 ppb

0.2 ppb
0.5 ppb

Not detected ~ 1.9 ppb
Not detected ~ 11 ppb *1 ppb

Not detected ~ 1 ppb

0.5 ppb

Not detected

0.5 ppb

Not detected

10 ppb

Not detected

50 ppb

4.6 ~ 4.7 ppb

2 ppb

Not detected ~ 6 ppb

5 ppb* 23 ~ 67 ppb detected from only specific specimen

18.(1) Takashi Tatsuno, Hiroyuki Nakazawa: Endocrine Disrupter Chemicals & Food Contact Containers,
Yuki Publishing Co.
(2) Mainichi Newspaper, Morning edition of 9/26/1997(3) J.A. Biles. Et al: Journal of Agricultural and Chemistry, vol. 45,3541(4) Central Science Laboratory Report FD 97/08 MAFF R&D and Surveillance Report 253 (1997)(5) Hitoshi Kawamura: Food Hygienics (3), 206, (1998)(6) Saitama Prefecture Health & Welfare section: press release, 6/30/1998(7) Yokohama City Education Committee: press release, 8/31/1998(8) PC Returnable Bottle Association report, Agency of Environment (Ministry of Environment)(Table 4-2) Bisphenol A not Migrated at Normal Temperatures(Migration Test Data for Baby Bottles)

①
②
③
④
⑤
⑥

Unit: ppb
95°C water / left overnight
3.3
3.1
5.5
3.9
4.5
3.9

Normal temperature
Not detected (<0.2)
Not detected (<0.2)
Not detected (<0.2)
Not detected (<0.2)
Not detected (<0.2)
Not detected (<0.2)①-⑥ Baby bottles available in the market(Yokohama National University, Environmental Science Research Center,9/17/1997)

High Performance

Polycarbonate Product• Lightweight• Safe/Hygienic

Sealable Containers, Lunch Boxes,
Baby Bottle Steamers

19Why is the migration amount of Bisphenol A from Polycarbonate Products small?

The following reasons are offered:• Polycarbonate resin and bisphenol A attract each other.
• It is difficult for non-reacted bisphenol A contained in polycarbonate products to moveto the surfaces of the products

Polycarbonate and bisphenol A contained in polycarbonate products are quite similar when expressed by achemical formula. The only difference is that the molecular weight of polycarbonate resin is larger than thatof bisphenol A. They attract each other because of their similar structures. This kind of chemical
relationship is scientifically known as “favorable compatibility.” The Bisphenol A contained inpolycarbonate is like an “unwelcome houseguest who feels comfortable staying in a relative’s house and isreluctant to leave.”
Another reason that only trace amounts of bisphenol A migrates from polycarbonate products is thatpolycarbonate occurs in a state of intertwined long strings in which it is difficult for bisphenol A to exit (Fig.
4). In addition, since the molecular movement of polycarbonate ceases under normal temperatures (below
145˚C), bisphenol A contained in the polycarbonate finds it very difficult to move.
There was almost no detection in the migration test
data of polycarbonate products, and, if any, only 5
ppb or below were detected, corresponding to 1/500of the national specification standard.
Thus, it is assumed from the data that non-reacted
bisphenol A near the surface of the productmigrated.
It has also been reported that there is no further
migration from the polycarbonate products thatgenerated the trace amount of migration after being
washed several times.

Bisphenol A(Fig. 4) Illustration of Polycarbonate Inside(Fig. 5) Migration Findings of Bisphenol A after Repeated Washes

Tableware
Baby Bottles

Before
Wash
39.1
3.9

Remaining Bisphenol A:
599 ppm for Tableware
20 ppm for Baby Bottles
Detection Limit: 0.5 ppb

1st
Wash
26.3
0.5

2nd
Wash
3.4
N/D

3rd
Wash
2.4
N/D

Unit: ppb
4th
Wash
1.7
N/D

5th
Wash
1.5
N/D

N/D = Not Detected(Hitoshi Kawamura: Food Hygienics (Vol.39,No.3, 6/1998)

20

What kind of practices/methods have been employed when producing
polycarbonate resin for food contact applications?

Self-standards have been established for amounts of bisphenol A to be contained inpolycarbonate for food contact applications so that people can feel safe using thepolycarbonate products. Polycarbonate and other materials to be molded for food contact
applications are controlled by distinguishing methods.

The amount of bisphenol A to be contained in polycarbonate for food contact applications is independently
fixed at 1/2 of the material quality standard level, namely, below 250ppm, and is voluntarily managed.
The distinguishing methods (grade name, color number, etc.) have been implemented so that resin notdesignated for food contact applications are not delivered by mistake. In addition, additives that may
increase the contained amount of bisphenol A are carefully classified to prevent their erroneous use.

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21

Does polycarbonate resin decompose and generate bisphenol A during
use of polycarbonate products?

Yes, bisphenol A may be generated when polycarbonate is decomposed.
Thus, manufacturers that supply polycarbonate resin give usage precautions in theircatalogs and technical materials, advising against use under conditions in which it canbe decomposed (hydrolyzed).

Depending on conditions for use, polycarbonate is hydrolyzed and generates bisphenol A when it comes into
contact with hot water or alkaline chemicals. Thus, precautions are given in catalogs and technical materials
advising against use under the following conditions.
(1) Depending on temperature or time, polycarbonate is hydrolyzed when it comes into contact withalkaline solutions such as sodium hydroxide, ammonium, etc. Thus, its use is limited depending on the
pH level of a chemical solution, the temperature and the time.
(2) Polycarbonate is also gradually decomposed by hot water. There is no problem, however, in using it forbaby bottles, tableware, coffee servers, drinking water containers, etc. as long as the handlingprecautions are observed, but use in hot water over many hours is not advised.

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22

Is Bisphenol A migrated when food in a polycarbonate container is microwaved?

The amount of bisphenol A migrated into water is not more than 2 - 4 ppb (2 - 4 µg/L ) when apolycarbonate container (tableware) that contains water is heated by microwave oven in themost extreme conditions. This amount is about 1/500 of the standard migration level specified
in Notification No. 370 issued by the Ministry of Health and Welfare (current Ministry of
Health, Labor and Welfare).

Polycarbonate Resin Manufacturers Group conducted the following tests with microwave ovens. The
results obtained showed a trace amount of migration, in levels safe for use.
A. Repeated heating tests by microwave oven
1) Method
Sample:Polycarbonate tableware
A bowl of a volume of 187 cm³ (upper diameter, 12.5 cm, lower diameter,
7.5 cm and height, 4.5 cm)
The amount of bisphenol A contained in the bowl, 100-130 ppm.
Contents:
160 ml of water (80% of the container)
Heating conditions: The amount of bisphenol A migrated into the (hot) water was measured after
heating for 4 min. by microwave oven.
Test method:Same bowl was repeatedly heated for 4 minutes, changed with fresh watereach time. The migration amount was measured in each cycle.
Measurement method: GC/MS method
2) Results
The migration amount obtained after repeatedly microwaving the bowl up to 100 times is shown in
Fig.5. As with the results of normal migration tests, the initial amount was relatively high, but it
decreased after repeating several times, and tended to show a fixed level thereafter.

Migration
Amount(µg/L )

Number of Heatings(Fig. 5) Repeated heating by microwave oven – (0-100 times)

23

B. Heating time by microwave oven and migration amount
1) Test method• Five sheets of polycarbonate test specimen (6 cm x 4 cm x 0.3 cm) were placed in a glass
laboratory dish (180 mm diameter, 50 mm height) containing 540 ml distilled water andmicrowaved (rated power consumption: 840 W, rated high- frequency output: 400 W).
• The amounts of bisphenol A contained in the test specimens were purposely fixed at threelevels of 20 ppm, 100 ppm and 390 ppm.
• Measurement by GC/MS method.
2) Results
The results are shown in Table 6.
As shown in this table, the following tendencies are recognized.
• The longer the heating time, the larger the migrated amount• The greater the amount of bisphenol A in the test specimens, the greater the migrated amount.
Overall, the migration amount is about 3.64 µg/L (3.64 ppb), even under the most extreme
conditions, approximately 1/500 of the migration standard (2.5 ppm).

(Table 6) The influence of bisphenol A (BPA) content and heating time
Test specimen(BPA content)
Below 20 ppm
100 ppm
390 ppm

Migration amount (µg/L)
Heating time (3 min.)Heating time (5 min.)
0.35
0.83
0.80
0.74
1.52
3.64

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24What is bisphenol A?

Bisphenol A is a white, solid substance at room temperature (23°C) and a low volatile
substance having the physical properties of a high melting point and a high boiling point.
Extremely small amounts of Bisphenol A dissolve in water.
Bisphenol A is a chemical substance widely used for polycarbonate resin, epoxy resin,polyarlyate and polysulfone as a raw material (monomer).

Chemical name:2, 2-bis (4- hydroxyphenyl) propane

Molecular structure:

Typical properties:(Table 7) Bisphenol A’s Typical Properties
Substance Name

Melting Point(°C)

Boiling Point(°C)

Vapor Pressure(Pa)

Solubility
in Water (mg/L)

Bisphenol A

150

250-252

5x10-6120

Official gazette serial number:
CAS NO.:

CDIL – SSL (4) – 123
80-05-7

Bisphenol A is composed of phenol and acetone.

AcetonePhenolBisphenol A

Water

25

I heard that even trace amounts of environmental hormones are hazardous.
Is bisphenol A also hazardous?

Trace amounts of bisphenol A are not hazardous. Some reports claiming that even trace
amounts of bisphenol A are hazardous can be attributed to confusion with TBT (tributyl),
dioxin, DDT, PCB, etc.

Opinions that even trace amounts of bisphenol A are hazardous have resulted from confusion with TBT(tributyl, a coating paint for the bottom of boats to prevent shellfish adherence), extremely low
concentrations of which exhibit strong toxicity in aquatic creatures, as well as dioxin, DDT, PCB, etc.
The governments of a number of countries believe that bisphenol A in amounts migrated frompolycarbonate products causes no problems to human health. As shown in Table 8-1, no biologicalconcentration (an accumulation of hazardous substances in high concentrations through food linkage)occurs since environmental remnants or accumulations of bisphenol A are extremely low.
(Table 8-1) Comparison of Environmental Hormonal Properties
Environmental
Plant
DioxinDDT
TBT
PCB
Hormonal Properties
EstrogenStrength of hormonal
StrongWeak
StrongWeakModerate
actionIntake
Small
Small
Small
Small
Large
Accumulation
Large
Large
Large
Large
Small
Effects on wild
Reported
Reported
Reported
Reported
Reportedanimals

Bisphenol A
Weak
Small
Small
Not Reported[Policies & Programs of Ministry of Environment]
Strategic Programs on Environmental Endocrine Disrupters 1998 （SPEED’98）
The Exogenous Endocrine Disrupting Chemical Task Force established by the Environmental Agency（current Ministry of Environment）published an interim report (1998). In the report about 70 substances (orgroups of substances) are suspected of having endocrine disrupting effects. The number of these substances
is expected to increase in the process of future study and research. It is hoped that future study and research
will make it easy to identify the existence of such effects and measure the strength of disruptive effects.
It has to be noted that the restrictions and environmental monitoring were not implemented from thestandpoint of coping with endocrine disrupting effects. It is therefore necessary to review the present
restrictions and monitoring activities, while enhancing our scientific knowledge.
Chemicals Suspected of Having Endocrine Disrupting Effects” was revised to be 65 substances in the year
2000. There are some substances in the table that were selected based on scientific documents (not based on
scientific test results) and bisphenol A was categorized the same as dioxins, PCB, DDT that clearly havetoxicity.

26

Based on the table, 12 substances in 2000, 8 substances in 2001 and 8 substances in 2002 were selected as
the prioritized substances for risk assessment tests. Bisphenol A as one of 8 substances in 2001 was selected
and has being tested.

(Table 8-2) Chemicals Suspected of Having Endocrine Disrupting Effects
Substances
1. Dioxins and furans
2.
Polychlorinated(PCB)

biphenyl

3. Polybromobiphenyl (PBB)
4. Hexachlorobenzene (HCB)
5. Pentachlorophenol (PCP)
6. .2,4,5-Trichlorophenoxyaceticacid
7. 2,4-Dichlorophenoxyacetic acid
8. Amitrole
9. Ａtrazine
10. Alachlor
11. Simazine (CAT)12. Hexachlorocyclohexane,
Ethyl parathion
13. Carbaryl
14. Chlordane

Use(Ｕｎｉｎｔｅｎｄｅｄ product)
Heat medium, non-carbon paper

Fire retardant
Bactericide, organic synthetic raw
material
Antiseptic, herbicide, bactericide
Herbicide
Herbicide
Herbicide,disperse
hardener for resins
Herbicide
Herbicide
Herbicide
Insecticide,
Insecticide
Insecticide

15. Oxychlordane
16. trans-Nonachlor

Chlordane metabolite
Insecticide

17.1,2-dibromo- chloropropane
18. DDT

Insecticide
Insecticide

19. DDE and DDD
20. Kelthane (Dicofol)
21. Aldrin

Insecticide (DDT metabolite)
Acaricide
Insecticide

22. Ｅndrin

Insecticide

23. Dieldrin

Insecticide

24. Endosulfan (Benzoepin)
25. Heptachlor

Insecticide
Insecticide

26. Heptachlor epoxide
27. Malathion
28. Methomyl
29. Methoxychlor

Heptachlor metabolite
Insecticide
Insecticide
Insecticidedye,

Restrictions
APL, WDPCL, LCSMAD, POPs, PRTR ClassⅠ
stopped production in 1972,
LCERMCS Class I in 1974, WPCL, MPPL,WDPCL, EQSGWSWP, POPs, PRTR ClassⅠ
LCERMCS Class I in 1979
unregistered in Japan, POPs
Lapsed in 1990,
WPACPDSL, PRTR ClassⅠ
Lapsed in 1975,PDSCL, FSL
Registered, PRTR ClassⅠ
Lapsed in 1975,
FSL, PRTR ClassⅠ
Registered, PRTR
Registered, MPPL, PRTR ClassⅠ
Registered, WPCL, EQSGWSWP, WDPCL
Hexachlorocyclohexane lapsed and banned sales
in 1971, ethyl parathion lapsed in 1972
Registered, PDSCL, FSL, PRTR ClassⅠ
lapsed in 1968,
LCERMCS Class I in 1981, PDSCL, POPs
Nonachlor unregistered in Japan,
Heptachlor lapsed in 1972
Lapsed in 1980
lapsed and banned sales in 1971,
LCERMC Class I in 1981, FSL, POPs
Unregistered in Japan
Registered, FSL, PRTR
Lapsed in 1975,
LCERMC Class I in 1981, SAC, PDSCL､ POPs
Lapsed in 1975,
LCERMC Class I in 1981, CPAC, PDSCL, FSL,
POPs
lapsed in 1975,
LCERMC Class I in 1981, SPAC, PDSCL, FSL,HSCHPCL, POPsPDSCL, WPAC , PRTR Class I
lapsed in 1975,
LCERMC Class I in 1986, PDSCL, POPs
Registered, Food Sanitation Law , PRTR
Registered, PDSCLLapsed in 196027

30. Mirex
31. Nitrofen
32. Toxaphene (Camphechlor)
33. Tributyltin
34. Ｔｒｉｐｈｅｎｙｌｔｉｎ
35. Trifluralin
36. Alkyl phenol (from C5 to C9)
Nonyl phenol /Octyl phenol
37. Bisphenol A
38. Di-(2-ethylhexyl)phthalate
39. Butyl benzyl phthalate
40. Di-n-butyl phthalate
41. Dicyclohexyl phthalate
42. Diethyl phthalate
43. Benzo(a)pyrene
44. Dichlorophenol
45. Diethylhexyl adipate
46. Benzophenone
47. 4-Nitrotoluene
48. Octachlorostyrene
49. Aldicarb
50. Benomyl
51. Kepone (Chlordecone)
52. Manzeb (Mancozeb)
53. Maneb
54. Metiram
55. Metribuzin
56. Cypermethrin
57. Esfenvalerate
58. Fenvalerate
59. Permethrin
60. Vinclozololin
61. Zineb
62. Ziram
63. Dipentyl phthalate
64. Dihexyl phthalate
65. Dipropyl phthalate

Insecticide
Herbicide
Insecticide
Antifouling paints on ships,
antiseptic for fishnets
Antifouling paints on ships,
antiseptic for fishnets
Herbicide
Raw material for surface -active
agents decomposition productRaw material for resins
Plasticizer for plastics
Plasticizer for plastics
Plasticizer for plastics
Plasticizer for plastics
Plasticizer for plastics(Unintended product)
Dye intermediate
Plasticizer for plastics
Synthetic raw materials for
medical products, perfume, etc.
2,4-dinitrotoluene intermediate(By-product of organic chlorinecompound)Insecticide
Bactericide
Insecticide
Bactericide
Bactericide
Bactericide
Herbicide
Insecticide
Insecticide
Insecticide
Insecticide
Bactericide
Bactericide
Bactericide

Unregistered in Japan, POPs
Lapsed in 1982
Unregistered in Japan, POPs
LCERMC in 1990 (TBTO: Class I, the remaining
13 substances: Class II), PRTR
lapsed in 1990,
LCERMC Class II in 1990, PRTR
Registered , PRTR
MPPL, PRTR
Food Sanitation Law, PRTR
Monitoring substances in water environment,
PRTR
MPPL, PRTR
MPPL, PRTR
MPPL
MPPL
MPPL, PRTR

MPPL

Unregistered in Japan
Registered
Unregistered in Japan
Registered, PRTR
Registered, PRTR
Lapsed in 1975
Registered, FSL
Registered, PDCL, FSL, PRTR
Registered, PDSCLRegistered, PDSCL, FSL, PRTR
Registered, Food Sanitation Law
Lapsed in 1998
Registered, PRTR
Registered, PRTR
Not produced in Japan
Not produced in Japan
Not produced in Japan(1) Besides the above substances, cadmium, lead, and mercury are also suspected of having endocrine disrupting
effects.
(2) In the environmental investigation column, (2 indicates that the substance has been detected and indicates that it
has not been detected. Substances with no mark have not been investigated.
(3) The laws described in the restrictions column indicate that the substance is subject to restrictions under such laws.
(4) "Registered", "lapsed", "unregistered in Japan," "Soil-persistent Agricultural Chemicals," "Crop-persistent
Agricultural Chemicals," "Water-pollutant Agricultural Chemicals" are based on the Agricultural Chemicals
Regulation Law(5) POPs are residual organic pollutants specified in the "World Action Plan Concerning the Protection of the Marine
Environment by Conducting Environmental Protection Activities on Land".

28

(6) Abbreviated Word of Law, Regulation, Standard and Restriction
APL : Air Pollution Law,WDPCL : Waste Disposal and Public Cleaning Law
EQSASWP : Environmental Quality Standards for Air Pollution, Soil Pollution, and Water Pollutants
LCSMAD : Laｗ Concerning Special Special Measurers Against Dioxins

POPs: Persistent Organic Pollutants
PRTR: Pollutant Release and Transfer Register
LCERMCS : Law Concerning the Examination and Regulation of Manufacture, etc., of Chemical Substances
WPCL : Water Pollution Control Law
EQSGWSWP: Environmental Quality Standards for Groundwater, Soil Pollution, and Water Pollutants,
MPPL : Marine Pollution Prevention Law

WPACPDSL : Water-pollutant Agricultural Chemicals
PDSCL : Poisonous and Deleterious Substances Control Law,
FSL : Food Sanitation Law
WWL : Waterworks Law
SAC : Soil-persistent Agricultural Chemicals
CPAC : Crop-persistent Agricultural Chemicals
HSCHPL : Harmful Substance Containing Household Products Control Law

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How safe is bisphenol A?

The allowable intake of bisphenol A, agreed upon by the governmental organizations ofJapan, U.S. and Europe based on the accumulated scientific knowledge, is 0.05
mg/kg-bw/day. Any intake below this level is not hazardous even when this substance isconsumed everyday throughout life.
Bisphenol A (BPA) has been used safely as an industrial chemical for nearly 50 years. The effects of BPA
have been extensively studied by industry, government and academic research groups in short and long term
animal tests, including several reproduction and developmental studies, multi-generation exposure studies,and a cancer bioassay, all of which are part of the open scientific literature. Importantly, none of thevalidated research results suggest that BPA would cause adverse effects from exposure through consumer
products or normal industrial production and use.
Summary of the BPA organization team (http://www.bisphenol-a.org/team.html) is as follows.
Endocrine Disruption and Bisphenol A (1), (2)Effects have been observed in compromised laboratory animals given high doses of bisphenol A. However,reproduction and development are not affected by relatively high levels of bisphenol A in multi-generational
studies, which are designed to detect disruptions in normal hormone activity (doses are compared to theextremely low levels of possible consumer exposure).
Estrogenic Activity of Bisphenol A (3), (4), (5)Bisphenol A exhibits extremely weak hormonal activity in test tube assays and in the rat dose test.
The estrogenic activity of BPA (in vitro study) has a potency of 10,000 times less than estradiol.
In addition, estrogenic activity was observed in animals administered large doses of BPA or animals
exposed via only experimental routes of exposure
Reproductive and Developmental Toxicity (1), (2), (6), (7), (8), (9)Bisphenol A has been extensively studied for reproductive and developmental toxicity in experimental
animals and has not shown a reproductive or developmental toxicity that produced fetal morphologicalabnormalities. For risk assessment purposes, the lowest no effect level (NOEL) when considering all
studies for either maternal or fetal effects is 50 mg/kg/day. BPA does not cause reproductive or developmental effects at any realistic dose .
Carcinogenicity (7), (8), (9)Bisphenol A is not a carcinogen, that is, it does not cause or induce cancer in laboratory animals. One of themost thorough studies in this area was performed by the U.S. National Toxicology Program. Based on
lifetime exposure cancer bioassays, the authors found that "there was no convincing evidence that bisphenol
A was carcinogenic for rats or mice of either sex" (NTP, 1982).
The conclusion of the International Agency for Research on Cancer and the United States Environmental
Protection Agency's National Center for Environmental Assessment is, "BPA is not a carcinogenic risk tohumans."30

Metabolism (10)Bisphenol A is rapidly metabolized in live animals and extensively excreted in urine and feces. A study
conducted by The Society of the Plastics Industry shows that levels of bisphenol A in the blood were much
lower for oral doses than for other routes of administration, such as injection in the abdominal cavity or
under the skin. Bisphenol A has not been shown to accumulate in test animals.

(1) Ema M. Fujii, et al., Rat two-generation reproductive toxicity study of Bisphenol A, Reproductive Toxicoloty,
15(5) 502-523, September-October 2001
(2) Tyl, R.W. et al., Three-Generation Reproductive Toxicity Study of Dietary Bisphenol A in CD Sprague-Dawley
Rats”, Toxicological Science, 68, 121-146 (2002)(3) Dodds, E.C. and Lawson, W. 1936. Synthetic estrogenic agents without the phenanthrene nucleus. Nature 137: 996.
(4) A.V.Krishnan, et.al., Endocrinology. 132(6), 2278-2286 (1993)(5) S.R.Milligan, et.al., Environ. Health Perspect, 106.23-26 (1998)(6) Environ. Health Perspect, 105(Sup.1), 273-274 (1995)(7) BUA Report 203, Bisphenol A, p75-85 (December 1995)(8) SPI: Bisphenol A: Summary of the toxicology studies, estrogenicity data and an estimation of no-obseved-effectlevel (1995)(9) TR-215 Carcinogenisis Bioassay of Bisphenol A (1982)(10) L.H.Pottenger, et.al, Toxicological Sciences, 54, 3-18 (2000)

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31

What is the low-dose issue of Bisphenol A?

When bisphenol A, in doses far lower than the allowable intake, was repeatedly
administered to pregnant mice, prostatic hypertrophy and a low sperm counts wererecognized in juvenile mice Thus, a question about the conventional allowable intake wasraised by Dr. vom Saal, et al. of Missouri State University.
A number of researchers have carried out experiments with greater numbers of animals andaltered dosages; however, no abnormality has been replicated.
The U.S. NTP (National Toxicology Program) reviewed these reports and published theiropinions in spring 2001; these effects are not recognized as definitive phenomena that are
general or reproducible, and are problems to be studied. There are, however, reliablegrounds for suspecting the existence of low-dose effects of bisphenol A.

Based on the results of animal experiments on the reproductive toxicity of bisphenol A as well as on general
toxicity, the allowable intake that causes no problems even when taken continuously everyday is specified tobe 0.05 mg/kg body weight/day in humans. According to this level, the safety standards for foodstuffs isregulated in Japan, Europe and America. Nonetheless, Dr. vom Saal et. al. of Missouri State University hasreported results of experiments in which there are abnormalities such as prostatic hypertrophy and adecrease in the sperm count in juvenile mice after repeated administration of 1/2000 to 1/20,000 of theallowable intake (20 µg/kg bodyweight/day, 2 µ/kg bodyweight/day) to pregnant mice.1)
Since the above results differ from conventional toxicological findings, a number of researchers havecarried out large-scale experiments as follows.
• Reproduction experiments in mice conducted in MPI research laboratories in the U.S.(SeeQ3-5, (1))• Two-generation study in rats in welfare scientific studies (See Q3-5, (2))• Three-generation study in rats conducted by the U.S RTI (Research Triangle Institute) (SeeQ3-5, (3))
Since a variety of investigational results have been reported, the Environmental Protection Agency (EPA)
has requested the National Toxicology Program (NTP) affiliated with the National Institute ofEnvironmental Health Science (NIEHS) for specialist advice on the low-dose issue. In response to theabove request, the NTP held a Peer Review Panel in October 2000.
Government officials from the U.S., Canada and Japan (35 in total) and about 170 NGO members of the
U.S. Consumers’ Federation as well as the Chemical Industry Associations, environmental protection
organizations (WWF, etc.) of Japan, the U.S. and Europe joined this Peer Review Panel.
1) Nagel, S.C., F.S. vomSaal, et al. (1997), “Relative binding affinity-serum modified access assay predicts therelative in vivo bioactivity of xenoestrogens bisphenol A and octylphenol.” Environmental Health Perspective 105(1): 70–76

32

The official opinion of the NTP summarizing the results of this Peer Review Panel are as follows.
(Original English-language text in the NTP 2001 “The National Toxicology Program Endocrine Disrupters
Low-Dose Peer Review Final Report, August 2001”)
There is credible evidence that low dose of BPA can cause effects on specific endpoints.
However, due to the inability of other credible studies in several different laboratories to observe low dose
effects of BPA, and the consistency of these negative studies, the Sub-panel is not persuaded that a low dose
effect of BPA has conclusively been established as a general or reproducible finding.
In addition, for those studies in which low dose effects have been observed, the mechanism(s) remains
uncertain (i.e., hormone related or otherwise) and the biological relevance is unclear.

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What are the recent test results on the low-dose toxicity effects of Bisphenol A?

The following are the reported results of the studies on the low dose effects that wereconducted during a period from 1998 to 2002.
No abnormality due to low doses was recognized in any of the following experiments.
(1) Reproduction tests of the Dr. vom Saal’s experimental results by the U.S. MPI
More reliable tests were carried out by increasing the number of mice.
(2) Two-generation proliferative toxicity tests by the Ministry of Health, Labor andWelfareProliferative toxicity tests up to the second generation of rats were carried out.
(3) Three-generation tests by Dr. Tyl of the U.S. RTI
Proliferative and general toxicity tests up to the third generation of rats in a wide
range of dose were carried out, this gained a reputation for being a highly reliable
test.

(1) The results of reproduction experiments conducted by MPI, an U.S. official safety researchorganization
The U.S Society of the Plastic Industry (SPI) and European Chemical Industry Association (CEFIC)
conducted the reproduction tests by consigning to MPI in relation to Dr. vom Saal’s experiments. (Table 9-1)
No similar abnormalities were reproduced in the results although the number of mice was increased in theexperiments.
The above results were disclosed in the following academic journal:“Cagen, S.Z., J.M. Waechter, et al. Normal Reproductive Organ Development CF-1 Mice following
Prenatal Exposure to Bisphenol A” Toxicological Science 50,36-44 (1999)
From Japan, the Bisphenol-A Safety Committee of Japanese Manufacturers, the Polycarbonate Resin
Manufacturers Group of Japan and the Epoxy Resin Manufacturers Association in Japan also participated in
the research activities.
(2) The results of the two-generation experiments in the welfare scientific research.
The Ministry of Health, Labor and Welfare (former Ministry of Health and Welfare) consigned the National
Institute of Health Sciences to carry out tests on the proliferate toxicity of bisphenol A in two-generations ofrats. (Table 9-2)
No definite changes conceivably due to the effects of bisphenol A were recognized using the same low oral
dose administered in the experiments carried out by Dr. vom Saal, on the conditions of genital organs,reproductive functions and hormonal dynamics over the two generations.

34

The results of the above experiments were released in the following academic journal:
Ema M, Fujii S, Furujawa M, Kiguchi M, Harazono A; Rat two-generation reproductive toxicity study ofbisphenol A, Reproductive Toxicology, 15(5) 502-523, September-October 2001

(3) The results of the three-generation experiments carried out by Dr. Tyl et. al. of RTI
Bisphenol A in the same low to high doses as in the experiments carried out by Dr. vom Saal wereadministered from parent to child to grandchild to great-grandchild of animals in an attempt to obtain moredetails. (Table 9-3)
In addition to ordinary indicators (life or death, body weight, feed intake, general conditions, weights ofmajor organs, eyes examination, parity, proliferative index, etc.), other indicators for investigating hormonal
effects (examinations of sexual maturity period, mating season, genital organs, sperm, etc.) were studied, noabnormality due to low doses was recognized, since the amount relating of proliferative toxicity was 50
mg/kg-bodyweight/day and the same of general toxicity was considered to be above 5
mg/kg-bodyweight/day.
The above results are released in the following academic journal:“Tyl, R.W., C.B. Myers, et al. Three-Generation Reproductive Toxicity Study of Dietary Bisphenol A in CD
Sprague-Dawley Rats”, Toxicological Science, 68, 121-146 (2002)(Table 9-1) Low dose Tests on Bisphenol A (MPI Research vs. vom Saal Research)
Assignment to Study and Parameters measured
Dose Level （µg/Kg/Day）
Gestation Days
Number of Mice at each Dose level
Total Number of Mice
Number of Pups
Number of Tested Mice
Measurement of Sex Development
Parameters measured and
Body weight
Results
Brain
Epididymis
Right caudal epididymis
KidneyLiver
Preputial gland Kidney
Prostate
Seminal vesicle
TestisSperm

SPI/CEFIC(MPI Research USA)
0/0.2/2/20/200
11-17
28
112
100
309
90 days of age
No Effects
No Effects
No Effects
No Effects
No Effects
No Effects
No Effects
No Effects
No Effects
No Effects
No Effects

vom Saal(Missouri Univ. USA)
0/2/20
11-17
7
14
14
14
108 days of age
−
−
−
−
−
−
−
Effect on weight−−
Effect on daily sperm
production

35

(Table 9-2) Low dose Tests on Rat Two Generation Reproductive Toxicity Study ofBisphenol A
Summary of Tests
Dose Level
Dosing Method
Number of RatsParameters measured

Results

To determine the low-dose effects of Bisphenol A(BPA) in two-generation (F0/F1/F2)
reproduction, BPA were given to male and female rats.
0/0.2/2/20/200µg/Kg/Day
dose BPA solved in water once daily by gastric intubations
25 male and 25 female / group
Parents of F0/F1/F2/F3
Body weigh, Organ weight and Brain, Heart, Lung, Liver. Prostate,Thymus Testis,
etc., Gestation, Lactation period, Vaginal opening, Sperm and parameters, General
toxicity , etc.
*No changes in epididymal sperm count/montility in Fo/F1 males.
*No necropsy findings or effects on organ weight including the reproductive organs in
any generation.
*No histopathologic evidence in any organs including the reproductive organs of both
sexes.
*No significant changes/effects indicated in reproductive or developmental
parameters at dose of BPA between 0.2 and 200µg/Kg/Day(Table 9-3) Three Generation Reproductive Toxicity Study of Dietry Bisphenol A in CD
Sprague-Dawley Rats
Summary of Tests
Dose Level andDosing Method
Number of RatsParameters
measured

Results

To determine the low-dose effects of Bisphenol A(BPA) in two-generation(F0/F1/F2/F3) reproduction, BPA was given to male and female rats.
0/0/015/0/3/4.5/75/750/7500 ppm (〜0.001/0.02/0.3/5/50/500 mg/Kg/day)dose BPA in diet
30 male and 30 female / group
Parents of F0/F1/F2/F3
Body weigh, Organ weight and Brain, Heart, Lung, Liver, Prostate, Thymus, Testis, etc.,
Gestation, Lactation period, Vaginal opening, Sperm and parameters, General toxicity ,etc.
*at 500 mg/Kg/day(7500ppm)
No effects on reproductive organ histopathology and function
Reduced body weight and reduced number of off-spring in F1/F2/F3.
*at 50 mg/Kg/day(750ppm)
Slightly reduced body weight*at 5 mg/Kg/day(75ppm)
No effects in any parameters*No adverse Effect level (NOAEL)
Adult systemic NOAEL = 5 mg/Kg/day(75ppm)
Reproductive and postnatal NOAEL = 50 mg/Kg/day(750ppm)

36

We understand that the allowable intake level of bisphenol A is being reviewed
in Europe; how is it being treated in Japan?

We think that the latest data used for reviewing the allowable intake level in Europe are not
relevant to the alteration of the allowable intake level (0.05 mg/kg-bodyweight/day) whichis the basis of the existing migration standard, specified in the Notification No. 370 issued
by the Ministry of Health and Welfare (current Ministry of Health, Labor and Welfare) inJapan.
As for the review by the European SCF (Science Committee on Food), the migration ofbisphenol A from a polycarbonate product is far less than the post-review allowable intake
level and thus the safety recommendations for the use of tableware, baby bottles and otherfood-contact containers will remain unchanged.

The following are the European SCF’s comparison between post-review allowable intake levels ofbisphenol A and the former ones.
Item
Inactive amount

Safety ratio(an indefinite coefficient)

Tolerable Daily intake(TDI)

SCF’s Review
5 mg/kg-bw/day(an inactive amount obtained ingeneral toxicity tests up to thethird generation, conducted by Dr.
Tyle)
500
(10: difference by animal species
10: difference by individuals
5: uncertainty of database)0.01 mg/kg-bw/day(treated as temporary TDI)

Conventional level
25 mg/kg-bw/day

same as left

0.05 mg/kg-bw/day

For example, suppose the migration standard for individual specifications of polycarbonate stipulated in
Notification No. 18 issued by the Ministry of Health and Welfare is used as the basis for revision, themigration standard will become as follows.
0.01 mg/kg-bw/day x 50 kg (human body weight) ÷ 1 kg/day (daily food intake) = 0.5 ppm
In other words, one fifth of 2.5 ppm, which is the existing migration standard
Even when the migration standard becomes 0.5 ppm, there will be no effective reason to change procedures,
since the migration amount from a polycarbonate product is far less than this level (ND-0.01ppm).

37

How does Bisphenol A accumulate?

Bisphenol A is not considered to accumulate in vivo, and so does not cause biologicalconcentration through the food-chain.

As for accumulation, 28% of bisphenol A was excreted into urine and 56% into feces, 8 days after a single
oral administration of bisphenol A, labeled with 14C, in male rats, while it was reported that no in vivo
accumulation was recognized 8 days after administration.1) 2) It was also confirmed by the additional tests on
the existing chemical substances carried out by the Ministry of Economy, Trade and Industry that theconcentration coefficient in the accumulation in aquatic creatures was 5.1 ~ 68. Since the judgment basis as
to whether or not the biological concentration exists is 100, it is conceivable that no biological accumulation
exists in aquatic creatures as the accumulation level is lower than the above standard.
Even when bisphenol A is taken into vivo, it changes to glucuronides in the liver. In addition, as residual
time in vivo is about 6 hours, bisphenol A is easily excreted with urine and feces.
1) Knaak J. B.,; Sullivan L. J., “Metabolism of bisphenol A in the rat, Toxicol. Appl Pharmacol”, 8, 175-184,
19662) Sangyo Keizai Shimbun, Evening edition dated August 20, 1998

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38

What is the biodegradability of Bisphenol A?

Bisphenol A decomposes in acclimated active sludge. It is also decomposed inriver water.

It has been confirmed that bisphenol A does not decompose under the test conditions specified by CDIL
(Chemical Drug Inspection Law), but decomposes in acclimated active sludge and also in river water. It isalso reported that bisphenol A at the concentration of 3 mg/L decomposed within 4 days and remained
concentrated below 0.1 mg/L.1)*When active sludge, a mud-like substance that contains microorganisms and protozoa, mixed with factory
waste and sewage, is aerated, organic substances are oxidatively decomposed by microorganisms andpartially incorporated in microorganisms before the waste is purified. Acclimated active sludge is active
sludge that is acclimated with bisphenol A for easier decomposition.
1) “Aromatics,” vol. 5, No. 3–4 (1998), p 46–62

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Arcade39

The effects of bisphenol A on the cerebral nerve and immune systemof fetuses/newborns have recently been reported; are these reports reliable?

The results of these studies on bisphenol A have been reported, but since the review of its
evaluation methods has just started, we have no confirmation as to whether or not thissubstance has such effects. The effects may be clarified, however, by future investigations.
Polycarbonates have been used in various applications since their inception, as no adverse
effects have been reported, they are safe to use.

At the 4th International Symposium on Environmental Endocrine Disrupters, sponsored by the Ministry ofEnvironment and held in December 2001, Mr. Yoichiro Kuroda of Tokyo Metropolitan Institute for
Neuroscience made the following comments in Session 1 (Effects on the Brain and Behavioral
Development).
“The data obtainable by the toxicological and epidemiological investigations enabling us to answer such
pivotal questions as “what kinds of chemical substances are responsible for which abnormalities of the brain
functions in developmental stage” are extremely limited. The research to investigate the behavioral
abnormalities of the next generation in experimental animals needs significantly more work and year-unit
periods in addition to there being more than several hundred chemical substances yet to be studied. Thus,
assay systems for actual screening are required.”In the experimental results currently being reported, there are a number of case studies under conditions ofintake such as injections directly to the brain or joint administration with a narcotic, which are extremely
different from actual conditions and actual daily life.

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Cellular Phone Keys40

Is bisphenol A discharged into the environment during the manufacturing
process of polycarbonate resin or the molding process of products?

During the manufacturing process of polycarbonate resin, wastewater is allowed to bedischarged after bisphenol A has been processed by an activated sludge. Bisphenol A is notdischarged during the course of the molding process of polycarbonate products.

It has been confirmed by testing whether or not bisphenol A is discharged into the environment during eachmanufacturing process of polycarbonate resin.
1) Manufacturing process of polycarbonate
During the manufacturing process of polycarbonate resin using the solvent method, non-reacted bisphenol A
is collected for repeated use. The collected waste water is processed with activated sludge, further treated for
active carbon adsorption and ozone treatment, etc. before bisphenol A is decomposed and removed foremission.
When the melting method is employed, bisphenol A is not discharged into the environment sincepolycarbonate resin is manufactured in closed facilities.
Incidentally, the concentration of bisphenol A was below 0.01 ppm, the same as other sea level areas, when
it was measured in the sea nearby a polycarbonate resin manufacturing plant.
2) Manufacturing process of pellets for molding materials
An attempt was made to analyze whether or not bisphenol A was contained in the cooling water during theprocess of cooling the string-shaped resin extruded as shown in an illustration (an outline of a pellet
manufacturing apparatus) in Q1-5. No bisphenol A was detected in the cooling water which was collectedduring the manufacturing process. Thus, bisphenol A is not discharged during the process of manufacturing
pellets for molding materials.
3) Process of molding a productAs shown in Fig. 1 (injection molding) referred to in Q1-6, melted polycarbonate resin injected into a moldbecomes a product when hardened. Thus, bisphenol A is not discharged into the environment during thisprocess and other molding processes.

41

Are there any precautions required for the disposal of polycarbonate
products?

No precautions in particular. You can dispose of polycarbonate products as plastic waste inaccordance with the regulations specified by local governments.

The Waste Disposal Law classifies disposal sites into three categories, namely stabilized disposal sites,
controlled disposal sites, and secluded disposal sites. Plastic waste including polycarbonate products areburned in an incinerator or disposed of at a stabilized disposal site. “Embers” of incinerated plastic wastes
are disposed of at a controlled disposal site.

(Table 10) Kinds of Industrial Waste Disposal Facilities
Disposal Site
Stabilized Disposal Site

Controlled Disposal Site

Secluded Disposal

Disposal & Management• Industrial waste having no risk of
becoming hazardous when covered
with rainwater kept for a long
period, and no risk of polluting the
nearby environment• Employ sealing structure for thebottom of the landfill, using clay,
vinyl & rubber sheets, etc. to prevent
ground water from being polluted byleaching• Provide gutter on the landfill
to prevent entry of rain water.
Sewage disposal facilities
for drainage from the landfill.
• Industrial
waste
containing
hazardous substances over the
regulated level

Disposable Industry Waste
Plastics, rubbers, metals, glass,ceramics, construction materials,
etc.

Cinder, sludge, wood, paper,
textiles, animal feces and urine,
animal corpses, dust/mullock, etc.

Products which have serious
effects on human health and theenvironment.
Hg, Cd, Pb, Organic Phosphate,
Cr(VI), As, Se, CN-compounds,
PCB, and their compounds

42

It was reported that bisphenol A was detected in the rivers nearby plastic waste
disposal sites; is this attributable to polycarbonate products disposal?

We don’t think it is attributable to the disposal of polycarbonate, since polycarbonate waste
makes up an insignificant amount of total plastic waste, and so the migrated amount ofbisphenol A is not significant.

According to the Plastic Waste Management Institute’s investigation in 2000, it was assumed that theamount of land filled plastics was 3,070.000 tons out of 10,980,000 tons of all plastics used domestically.
(the investigation material in 2000)
Approximately 200,000 tons of polycarbonate was used domestically in 2000. Suppose half the above
amount was disposed of, it is only 2% of the total plastics used in land fill. Polycarbonate waste was hardly
found in landfill sites. Besides, as the migration amount of bisphenol A from a polycarbonate product is a
trace amount, we don’t think it is attributable to polycarbonate disposal.
The migration of bisphenol A from plastic wastes and the amount of bisphenol A detected from rivers aredescribed in many reports on the investigations carried out by publicly established research organizations
and universities.
Table 11.1) and Table 12. 2) show the results of measurement of migrated bisphenol A from plastic products.
It is clear that more migrates from electric cord (PVC), synthetic leather, sheet, etc. than the extremely small
amounts that migrate from polycarbonate products (storage containers, CDs).
Investigations carried out by the Kanagawa Environmental Research Center, the Environmental Monitoring
Laboratory, etc. found that bisphenol A was detected in high concentrations from leachate from waste
plastic disposal sites. [Table 13] 3) However, since it is not conceivable that polycarbonate products in large
quantities were disposed of in these disposal sites, polycarbonate is unlikely to be the source of discharge ofbisphenol A.
We think the specific sources of discharge and environmental countermeasures for reduction will be
developed, as the respective administrative authorities are now carrying out broader investigations on thesource of discharge of bisphenol A.

1) Takashi Yamamoto, Akio Yasuhara: Migration of bisphenol A from waste plastics,
at the 7th Meeting of Japan Society for Environmental Chemistry. P252-253, 1998
2) Tsutomu Imaoka, Yusou Hotehama: Migration of bisphenol A from waste plastic system materials,
at the 2nd study meeting of the Japan Society of Waste Management Experts, P 1011–1013, 2001
3) Hiromi Sakamoto, Hiroshi Fukui, at the study meeting of 11th Japan Society of Waste Management Experts,
p1098-1100, 2000

43

(Table 11) Plastics supplied for the experiments and the migrated bisphenol A.
Material
Aspect
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17

Name

storage container, transparent
film, black
wiring plug, grayelectric cord, graysheet, whitewiring plug, white
synthetic leather, graywiring plug, blue
synthetics, graysheet, translucent
film, translucent
wiring plug, blacksynthetic leather, graywiring plug, green
IC boardCDpipe, gray

Migration Test (water)
BPA content(ng/g)

polycarbonate
not known
not known
pvc
not known
not known
not known
not known
not known
not known
not known
not known
not known
not known
phenol resin
polycarbonate
pvc

Duration
(day)

4.2
9.1
3.3
1980
N.D.
N.D.
9810
N.D.
N.D.
168
N.D.
77
139000
N.D.
67.7
23.3
10.7

12
14
14
14
13
13
13
14
14
14
13
13
14
14
14
14
14

Migration(µg/L)

1.1
1.6
1.4
700
N.D.
N.D.
2250
N.D.
N.D.
26
N.D.
18
12300
N.D.
10.1
6.0
3.0

(Table 12) The results of migration tests on waste plastics and plastic materials
Melted plastic block in A city
Melted plastic block in B city
PC pellet
PC (ball point pen body)Ball point pen grip
CD w/print
CD w/o print
Soft PVC pellet
Hard PVC pellet
PVDC wrapping film
PVC pipe
PVC cover (electric cord)
PVC garden hose
PVC sheet (1)PVC sheet (2)PC sheet (1)TPO sheet
HDPE sheet

142.1
516.1
0.6
57.4
39.8
9.0
28.8
42.3
8.2
2.0
0.1
25.3

2048.01284.0

84.1
0.0
0.5
0.1
0

100

200

300

400

500

600

700

BPA Migration (µg/kg)

44

(Table 13) Migration of bisphenol A from terminal waste disposal sites

Bisphenol A concentration(µg/L)

Sites Tested

Start of landfill
What landfilled
Waste Landfilled in 1997
(m3)
Landfill Site Capacity (m3)
Total Waste Landfilled in2000 (m3)

D Site
1st phase 1993~
2nd phase 1999~
Incineration ash

E Site1986~
Incineration ash
Crushed waste

F Site
1st phase 1984~
2nd phase 1998~
Incineration ash
Crushed waste(No BPA detected at Site H)

G Site1988~

H Site1997~

Incineration ash
Crushed waste

Incineration ash

-

5,211

1,655

8,366

1,018

25,500155,170456,000

158,700

200,000

11,239109,412211,574

143,168

1,222

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45

Polycarbonate resin has been used for returnable milk bottles and drinking
water bottles in Europe and America. What are consumer reactions?

Consumers have continued to use these products as before the endocrine issue wasraised.

In Europe, polycarbonate resin is used mainly in Germany and Holland for returnable milk bottles andmineral water, etc. In Germany, polycarbonate bottles have been used for 9 years complying with thegovernment basic policy for not increasing “one-way bottles.”A representative German dairy company made the following statement. (Report released in relation with thereuse-model business consigned by the Ministry of Environment in 1997).
1) Milk bottles and other tableware that meet the specifications of the U.S.FDA are used. Dairy products
containers made of polycarbonate were investigated in the U.S. in 1990, and as a result, it wasannounced that they have no adverse effects on the health of babies given dairy products contained in
the polycarbonate bottles.
2) Polycarbonate is adopted as it has high heat resistance and does not absorb original food tastes.
3) The same returnable bottle is used roughly 50 times.
Because of the above safety features, polycarbonate bottles are used for returnable milk bottles.
As for drinking water bottles, 20-liter bottles are widely used in both Europe and America. Many people
have seen these transparent bottles atop water coolers.
No other material is better than a rigid polycarbonate bottle, which even when filled with 20-liters ofmineral water is still light enough to be set on a water cooler. As the bottle is transparent, the remaining
amount can be seen at a glance.

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46

What do you think about the safety of polycarbonate tableware and baby
bottles?

These
products
safeMigration
to use. amount of bisphenol A from polycarbonate baby bottles andThey aresafe toareuse.
The
Food Hygiene
issuedby theset
MHW)
migrationlevelsfromtablewareis belowLaw
1/50(Notificationlevel of the No.370
migration
standardby thesetFood
HygieneLaw.
polycarbonate products into food below 2.5 ppm (2500ppb). (See Q2-5)
The maximum migration level of bisphenol A detected from tableware and baby bottles used
under normal conditions is 50 ppb. (See Q2-7)
50 ppb ÷ 2500 ppb = 0.02 (below 1/50 level under normal conditions)

Polycarbonate resin is a high-performance plastic characterized by its transparency, light weight, durability,
impact resistance, strength and heat resistance. Food-contact products such as tableware, baby bottles,
water bottles, reusable food containers made of polycarbonate resin are safe to use and have numerous
benefits.
According to the Expert Report on Endocrine Disrupting Substances of the Ministry of Welfare (currently
the Ministry of Health, Labor and Welfare) 2002, “No reproducible experimental results have been obtained
and at this point of time, it is doubtful whether we can conclude that there are endocrine disrupting effects inthe low-dose range”
In Japan, Ministries and local government agencies do not prohibit the production and sale food-contact
products made of polycarbonate resin. Consequently PC tableware and PC baby bottles are produced andmarketed in the Japanese market.



Polycarbonate Tableware
Japan Industry Union of Plastic Housewares Manufacturers (JIUPHM) made “The Production
Guidelines on Polycarbonate Tableware and The Notes on Use of Polycarbonate Tableware” in 1999.



Polycarbonate Baby Bottles
Japan Conference of Baby Bottle Manufacturers (JCBM) made the production guidelines and the notes
for safe use (in 2000) in response to the requests of the Bureau of Public Health Tokyo Metropolitan
Government as below.
・“The Production Guidelines on Polycarbonate Baby Bottles” describes how to produce hygienic
products with less bisphenol A.
・“The Notes on Use of Polycarbonate Baby Bottles for Consumers” and “The Notes on Use of
Polycarbonate Baby Bottles for Maternity Hospital and Facilities” describes their safe andhygienic use.

* Production Guidelines for PC baby bottle manufacturers（in Japanese).
http://www.kenkou.metro.tokyo,jp/shokuhin/news/1999/000223-2.html

47

* Notes on use of PC Baby bottles for consumers and maternity hospitals（in Japanese).
http://www.kenkou.metro.tokyo,jp/shokuhin/news/1999/000223-3.html
http://www.kenkou.metro.tokyo,jp/shokuhin/news/1999/000223-4.html

Polycarbonate tableware and baby bottles are manufactured under strict process controls as well as quality
controls covering the materials and products. They are safe to use when observing the relevant precautionsof the respective products.
* We are supplying safer materials to be used for food-related products including baby bottles through astrict independent control standard, and observance of the specification standard in Notification No. 370
issued by the Ministry of Health, Labor and Welfare in accordance with the Food Hygiene Law.
* As for tableware, we are promoting a safer molding method through compliance with the precautions forhandling and the molding process guidelines established by the Japan Industry Union of Plastic House
ware Manufactures.
* We are also promoting the safe production of baby bottles through compliance with the precautions forhandling and the production guidelines established by the five companies’ liaison assembly on baby
bottles.
It is important to remember the advantages of polycarbonate tableware and baby bottles, which cannot be
equaled by other materials.
* Polycarbonate tableware has the following advantages.
• Does not break when dropped or used with other tableware• Light and easy to carry• Easy to wash as it sinks in water and is easy to sterilize in boiling water• Heat resistant• Can hold and carry hot food such as soup because it insulates heat
• Available in colorful designs* Polycarbonate baby bottles have the following advantages.
• Safe as they don’t break like glass products• Light and easy to carry• Heat resistant• Easy to sterilize in boiling water• Transparent and easy to see remaining contents

48

How are polycarbonate manufacturers coping with the environmental
hormones issue of Bisphenol A in Japan?

The manufacturers supplying polycarbonate have organized the Polycarbonate Resin
Manufacturers Group to conduct safety-related tests and collect domestic and overseas data
/information on safety. The group published Q & A sheets as well as set up a web-site, etc.
and thereby keeps on providing the manufacturers and consumers of polycarbonate productswith up-to-date information. They are also doing all they can to liaise with relevantorganizations to disseminate the most up to date information.

Global efforts to tackle the issue are described in Q5-4, but domestically we are making every possible effort
to collect technical information concerning safety through cooperation with the following organizations.
(1) Japan Chemical Industry Association (JCIA)
JCIA is participating in investigation, collection and exchange of information on common chemical
substances, as well as taking part in relevant lectures and international conferences, etc. JCIA is also
conducting international activities such as LRI (Long-range Research Initiative) and Responsible Care
Activities.
(2) BPA/PC/EX Committee
The committee, which consists of the BPA Safety Committee of Japanese Manufacturers, the Polycarbonate
Resin Manufacturers Group and the Epoxy Resin Industry Association, is working on common issues.
The BPA Safety Committee of Japanese Manufacturers is organized by the following 4 BPA manufacturing
companies and conducts investigation and research activities on the safety of bisphenol A.
• Idemitsu Kosan Co., Ltd.
• Nippon Steel Chemical Co., Ltd.
• Mitsui Chemicals, Inc.
• Mitsubishi Chemical Corporation

The Polycarbonate Resin Manufacturers Group’s webside(P-Magazine) discloses news on polycarbonate
resin, polycarbonate products and bisphenol A as well as technical data and safety information.
Please visit (P-Magazine) http://www.polycarbo.gr.jp/49How are you cooperating with overseas polycarbonate and bisphenol A
manufacturers in relation to the environmental hormone issue?

We organized the PC/BPA Global Team in cooperation with polycarbonate and bisphenol
manufacturers in Europe and America in an attempt to collect/exchange information
concerning the environmental hormone issue and to collect /analyze scientific data obtained
from various tests. From a common point of view, we are reporting relevant information topolycarbonate manufacturers, consumers and also to each country’s government.

It is required for bisphenol A and polycarbonate manufacturers worldwide to fully cooperate with each otherto cope with the endocrine disrupter issue, not only in Japan but also in all other countries in the world.
In view of the above concept, in late 2000 the leaders of the business departments of the bisphenol A andpolycarbonate manufacturers met together and reached an agreement to globally respond to the issue. Undera “Leadership Team” consisting of the principals, a “Science Team” is working on scientific investigationsof the effects on aquatic creatures, animals, human beings, etc. and a “PR/Advocacy Team” is working oncollection and disclosure of the required information.

(1) Companies and organizations participating in the PC/BPA Global TeamJapan:

Polycarbonate Resin Manufacturers Group (polycarbonate resin)
Bisphenol-A Safety Committee of Japanese Manufacturers (bisphenol A)

Europe and America:
SABIC Innovative Plastics (polycarbonate resin, bisphenol A)
Bayer MaterialScience (polycarbonate resin, bisphenol A)
Dow Chemical (polycarbonate resin, bisphenol A)
Sunoco (bisphenol A)(2) Major scientific tests conducted by PC/BPA Global Team• Bisphenol A low-dose test in mice (Reproduction test by Dr. vom Saal of Missouri State University)• Bisphenol A low-dose test for multi generation in rats by Dr. Tyl• Bisphenol A risk assessment test in mice, snails, fishes in response to the request by the European
Parliament (on-going)50