Bisphenol a - an industrial chemical with adverse effects
An industrial chemical with
(German Federal Environment Agency)
Press Office, Wörlitzer Platz 1,
06844 Dessau-Roßlau, Germany
Updated version July 2010
Cover photo: Natalia Bratslavsky / Fotolia.de
derived from it. Within the scope of this programme
Bisphenol A was one of the first synthetic substances of
Member States assessed the risk to humans and the
which it was known that it can have a similar effect to
environment from substances used in large quantities.
that of the female sex hormone oestrogen. The British
In 2003, the European Commission published an initial
biochemists Edward Charles Dodds and Wilfrid Lawson
risk assessment for bisphenol A , as agreed among
[1; 2] searched in 1936 for chemicals that were able
the Member States. In 2008, the United Kingdom – the
to replace natural oestrogen in medical therapy. This
rapporteur Member State – supplemented and updated
female hormone was extremely expensive, since it had
the report with new information . The original as-
to be synthesized from the urine of pregnant mares.
sessment from 2003 and the addendum from 2008
In similar animal experiments carried out today with
have recently been merged into one document .
rats, whose ovaries have been removed, scientists have
Reference to EU risk assessment in the following text
identified bisphenol A as a substance with weak oestro-
concerns data collected in the merged reports.
genic activity. Nevertheless, bisphenol A did not pursue a career in pharmacy, since the same researchers soon
How and where does bisphenol A occur?
identified much more potent synthetic oestrogens, in-
Bisphenol A is found in many everyday products: in CDs
cluding, above all, diethylstilbestrol (DES) , which was and DVDs, in cash register receipts made of thermal used and misused as a drug in the following decades
paper and in plastic bowls. But what is bisphenol A, for
what purpose is it used and in what quantities? Box 1 explains its chemistry, production and subsequent pro-
No longer needed as a drug, bisphenol A found an
alternative career as industrial chemical, and it is
nowadays found in many everyday products. The hoped Products containing bisphenol A
for pharmacological blessing turned out, however, to
The substance is found in many technical appliances
be a problem, since bisphenol A affects our hormone
and household products that are made of very stable
system. How dangerous bisphenol A can be for hu-
plastics, so-called polycarbonates.
man health is presently the subject of dispute. While
Polycarbonates are produced from bisphenol A and
some scientists raise the alarm, others play down the
have great stability, toughness, stiffness and hardness,
issue. Is there something to the reports, how dange-
as a result of which they are shatter-resistant. In addi-
rous is bisphenol A, in which concentrations are hu-
tion, they are characterized by good electrical insula-
mans and the environment subject to exposure, and
tion properties and enhanced weather and radiation
how does the German Federal Environment Agency
resistance. Mobile telephones and motorcycle helmets,
(Umweltbundesamt – UBA) assess the risk?
for example, are made of polycarbonates. Furthermore, polycarbonates are employed in many areas as con-
With this background paper, the Federal Environment
structional materials; for example, for transparent
Agency (hereafter: also UBA) would like to describes
roof coverings, computer housings and water boilers.
what sort of a substance bisphenol A is, for what purpo-
Medical equipment (for example, dialysis equipment)
se it is used, how it takes effect, and how the UBA and
and food containers (for example, baby bottles) are also
others assess the risk to humans and the environment.
manufactured with polycarbonates. Finally, polycarbo-
In many cases this report draws on data from the
nates are characterized by a further property: though
Council Regulation (EEC) No. 793/93 on existing sub-
they are inflammable, they cease to burn after removal
stances and the Existing Substance Programme (ESP)
from an ignition source .
BOX 1 Explanation of the chemistry of bisphenol A
Chemical name: 2,2-Bis-(4-hydroxyphenyl)propane
C H O
As intermediate: polymerization to polycarbonate
Produced through condensation of two parts of phenol plastic and epoxy resins. In this process bisphenol A is and one part of acetone.
chemically converted into a polymer (plastic or epoxy resin) and at the same time firmly bonded in the
Commercial supplies of bisphenol A contain up to 16
different contaminants with a phenol structure. In the
As chemical: application as stabilizing agent and
light of total production in the EU of about 1.15 million colour development component. In this application, tonnes per year, this amounts to about 10,000 tonnes of bisphenol A is employed in its unchanged form, in contaminants.
which it is also present in the product.
BOX 2 Selection of products that are frequently manufactured with polycarbonate plastics or epoxy resins and can therefore contain bisphenol A [8; 9; 11]
• Safety glass (glassy polymers)• Parts for plugs and switches• Housings of electrical/electronic devices and equipment (for
example, mobile telephones, water boilers, coffee machines and computers)
• Optical storage media, such as CDs, DVDs and Blu-ray discsTM• Car parts (transparent plastic parts), such as reflectors• Bottles and containers for food and drinks• Spectacle glasses• Microwave-proof crockery, plastic cutlery and cooking utensils • Motorcycle helmets and shields• Medical equipment
• Floorings• Varnishes (for example, as coatings for household appliances
• Beverage cans and food cans (as inner coating)• Printed circuit boards in electronic products• Composite materials (e.g. for tennis rackets and surfboards)• Adhesives• Inner coatings for decontamination of drinking water con-
tainers and wastewater tanks and pipes .
Epoxy resins are also produced from bisphenol A.
mon colour development component in thermal paper
Epoxy resins are fluid. With the addition of hardeners
they react into hard, indissoluble and chemical-resi-stant plastics. They are predominantly used in the form
In PVC plastics, bisphenol A serves the purpose of inter
of resin adhesives, coating resins and casting resins for
alia retarding the ageing of soft PVC (for instance, in
surface coatings, including the inner coatings of metal
high-temperature cables and tyres). It is also employed
packaging (such as beverage and food cans) [9; 11].
as a stabilizer in brake fluids, thereby enhancing both
In the production of polycarbonates and epoxy resins
useful life and durability .
bisphenol A is chemically converted in such a way that
long chains and nets – so-called polymers – are formed
In the application of bisphenol A as an additive the sub-
from the individual molecules. Polymerized bisphenol
stance is not chemically bonded. It is therefore more
A is chemically bonded, but can be released under
easily released from products such as thermal paper or
certain conditions (See Chapter: „How does bisphenol
PVC products . Bisphenol A is contained in these pro-
A enter the human body?"). Occasionally, all of the
ducts, however, in comparatively small quantities. The
bisphenol A is not chemically converted in produc-
share of bisphenol A in thermal paper, for example, is
tion processes. Products made of these materials can
1 % [6; 9]. In soft PVC, such as cables, bisphenol A can
therefore contain unbonded bisphenol A residues. The
account for 0.5 % of the employed plasticizer ,;
content is, however, small; it lies in the case of polycar-
the actual concentration in the product is accordingly
bonates in the ppm range (that is, parts per million),
in most cases less than 0.1 %.
which means that the bisphenol A content accounts for just a few millionths of the product) .
A further special application is in dentistry. Here, fillings and sealing materials (similar to epoxy resin,
Besides conversion to polymer polycarbonate or epoxy
and known as dental composites) are produced from
resin bisphenol A is also used as an additive; for examp-
substances such as bisphenol A glycidyl methacrylate
le, for coating thermal paper, in the production and
(bis-GMA) and bisphenol A -dimethacrylate (bis-DMA),
processing of PVC (polyvinylchloride) plastics as well as
which are based on bisphenol A. Bisphenol A itself is
in brake fluids.
not used [9; 15]; it can, however, be released during or after dental treatment .
Thermal papers are special papers, with which the di-rect transfer of heat during printing leads to a chemical Bisphenol A is also a starting material for tetrabromo-reaction and, as a result, to blackening of the paper
bisphenol A (TBBPA), which is employed as a flame re-
. Bisphenol A serves here as developer substance
tardant . In the environment, TBBPA can reconvert to
alongside the actual dye. It is worldwide the most com-
bisphenol A (reductive halogenization) , .
BOX 3 Selection of products in whose manufacture bisphenol A can
amounts to around 1 million tonnes, of which more
than 90% are used as plasticizers in the production of
• Thermal paper (e.g. fax paper,
soft PVC . Consumption of flame retardants in the
cash register receipts) [6; 9; 13]
EU amounted in the year 2006 to 465.500 tonnes .
• Electrical and electronic
products (treatment of envelop-
Figure 1 shows application of bisphenol A in the EU
ment materials or electronic
(reference period: 2005/2006 ). The largest share
components with TBBPA as flame
is further processed in Europe to polycarbonates and
retardant) [6; 9]
epoxy resins (865,000 and 192,000 thousand tonnes
• Brake fluid 
per year, respectively, a total of 1.06 million tonnes per
• Rubber and PVC products, such
year). All other applications total about 23,000 tonnes
as high-temperature cable (as a
per year. In comparison to major applications this is
stabilizer) [6; 9]
only a small share, but regarded in absolute terms it
• Dental fillings and sealing
is still a lot, namely 600 40-tonne HGVs. It includes
materials, braces, prostheses (as
thermal paper coating (about 1,900 tonnes per year
starting material for composites)
and PVC (polyvinylchloride) processing (a total of 1,800
tonnes per year). Usage for the production of pheno-plast casting resins, unsaturated polyesters, brake flu-
Box 3 displays a selection of products, in the manuf-
ids, tyres and other applications  amount to 19,700
acture of which bisphenol A can be employed as an
tonnes per year. 65,000 tonnes per year are exported
additive, or that are possibly furnished with TBBPA as a
from the EU.
Outside the EU, bisphenol A serves as starting material
Environmental and consumer protection associations
for the production of tetrabromobisphenol A (TBBPA).
have also detected bisphenol A or bisphenol A deriva-
Approximately 6,500 tonnes of this substance are im-
tives in aluminium bottles, beverage cans (beer cans)
ported each year into the EU, and tens of thousands of
with plastic inner coatings [18; 19], swimming aids, gar-
tonnes enter the EU  each year in products treated
den hoses and nail varnish .
with flame retardants. Since TBBPA can be converted in the environment into bisphenol A, this substance has
Quantities produced and applied
to be taken into account in the assessment as a possible
In 2006, the chemicals industry produced worldwide
source of bisphenol A .
3.8 million tonnes of bisphenol A . This corresponds to almost 100,000 40-tonne HGVs, the largest that are
How does bisphenol A enter the human body?
permitted on our roads. Lined one behind the other,
According to present knowledge, we take in bisphenol
the line of HGVs would be around 1,900 kilometres
A primarily by way of food . And how does the sub-
long, somewhat longer than the distance from Rome
stance get into food?
to Hamburg. In 2005/2006 almost one-third of world production (1.15 million tonnes) was accounted for by
Bisphenol A can be found in cans, namely in their
the then 15 Member States of the European Union (EU); inner coating. From there the substance can get into Germany accounting for around 70% of European pro-
food. This happens by means of the chemical process
duction (840,000 tonnes of bisphenol A ). By com-
of hydrolysis, by which bisphenol A is released through
parison, other chemicals that are also produced and
chemical reaction with water from the bonded (poly-
consumed in large quantities in the EU are phthalates
mer) form . How much of the substance is freed
and flame retardants. Annual production of phthalates
heavily depends on the can-material production pro-
Figure 1 Application of bisphenol A (annual production quantity in 2005/2006 in the EU: 1.15 million tonnes. Database: )
Epoxy resin (18%)
Other (incl. coating of thermal paper, additive PVC processing, synthetic resins) (2%)
cess. In food from cans with a coated inner surface,
even pipe materials coated with expoxy resin constitute
chemical measurements have shown bisphenol A con-
no relevant source of human exposure to bisphenol A.
centrations of between 5 and 38 µg/kg (micrograms per kilogram) of can content. In canned meat even higher
Besides pure bisphenol A, phenolic contaminants in
concentrations have occasionally occurred .
technical grade bisphenol A could also contribute to the effect (see Box 1). They are structurally similar and
Tests with polycarbonate containers have also shown
therefore presumably have an oestrogenic effect. In
that bisphenol A can be released, for instance, through
total, they amount to 10,000 tonnes per year in the EU.
hot water . Detergent residues encourage the re-
Since toxicological analyses are mostly carried out with
lease of bisphenol A, the quantity depending on tem-
the pure chemical, the risk they represent for human
perature, heating duration and water hardness ,
health cannot be reliably assessed.
as well as on the detergents used . In this case, bisphenol A is probably not detached from the plastic;
Conclusion: Since materials containing polycarbona-
the plastic decomposes in the course of time and sets
tes are in widespread use and bisphenol A is variedly
bisphenol A free [28; 31].
employed, practically every person comes into contact with the substance. Different studies assess the median
People who receive intensive medical care are much
daily intake of adults and children at between 0.03 and
more exposed to the chemical than the general popu-
0.07 micrograms per kilogram body weight and day
lation. High exposure was particularly found during
(µg/kg bw/day) , . For bottle-fed infants the value
dialysis treatment and in newborn intensive care units
is 0.8 µg/kg bw/day . Scientists have identified the
[32; 33]. Increased concentrations of bisphenol A in the
highest daily intake by children as 7 µg/kg bw/day 
human body have also been measured at workplaces in
(median implies that half of the investigated samples
the production and processing of bisphenol A .
were below the stated values).
Bisphenol A virtually does not occur in drinking wa-
Available data on human exposure indicates that as yet
ter. Its concentrations in Germany's surface waters
not all sources of exposure have been identified, and
are already rather low, with annual means of 0.5 µg/L
that besides oral intake there are probably other intake
and maxima of 5 µg/L (see section: "Concentrations in
the environment"), and this is further reduced in the course of drinking water abstraction and treatment.
How does bisphenol A enter the environment?
This is confirmed by a study which found only one-
As a rule, bisphenol A enters the environment by way
thousandth of these concentrations in bank-filtered
of wastewater, primarily through discharge into water
water from the Danube and in drink-ing water from
bodies. A large proportion comes from businesses that
Lake Constance (0.0003 – 0.002 µg/L) .
produce and process bisphenol A. At the top of the list are manufacturers of polycarbonates and epoxy resins
Nearly the same is true for the release into drinking
. Furthermore, companies that produce and recycle
water of BPA from tech-nical storage systems and de-
thermal paper or process PVC plastics discharge bisphe-
vices for the distribution of drinking water that are
nol A into the environment .
coated with epoxy resin for corrosion protection. These coatings mainly consist of BPA that is polymerised and
With the wastewater flow bisphenol A is then fed eit-
therefore strongly bound. Results from studies carried
her into the wastewater treatment plants of the compa-
out by the Federal Environment Agency and elsewhere
nies or into municipal sewage treatment plants.
show that when properly and professionally applied, the coating - after the system is first put into service -
Insofar as wastewater plants are supplied with sufficient
causes no release of BPA into drinking water or at most
oxygen (aerobic conditions), microorganisms can easi-
a release as low as to result in concentrations well be-
ly degrade bisphenol A in water. This is confirmed by
low 1 µg/L.
different laboratory tests, according to which the sub-stance degrades almost completely within 2 – 17 days
BPA concentrations above 30 µg/L were occasional-
[5; 6; 37]. If too little oxygen is available (anaerobic
ly measured only where excessive heating (> 70°C)
conditions), however, the bisphenol A content reduces
occurred in coated hot-water pipes. In one case, con-
either not at all or extremely slowly [38; 39]. Practical
centrations of up to 280 µg/l were reached. This was
experience also confirms that wastewater treatment
a hot-water pipe system which had not been properly
plants eliminate bisphenol A with varied success. An
and professionally installed and oper-ated and in which investigation at different wastewater treatment plants bisphenol A could accumulate in a circulation system.
in Germany produced degradation rates of between 61
Such problems can be avoided through the selection
and 98 per cent . Studies from Canada show, too,
of suitable materials (the UBA publishes a list of tested
that degradation in wastewater treatment plants can
and therefore suitable materials ) and by commissio-
vary greatly. They established an average degradation
ning qualified pipe installers. Under these conditions,
rate of 68 % . Degradation rates depend on the
method of wastewater treatment and the performance
Report calculated an average water concentration of
of the treatment plant. Should purified wastewater still
0.01 µg per litre (median: 50th percentile). Statistically,
contain bisphenol A, the substance is discharged from
in 5 % of all European waters concentrations of more
wastewater plants into water bodies. Here it is further
than 0.35 µg/l are to be expected (statistical 95th per-
degraded under aerobic conditions. Varied evidence of
centile). Sediment concentration is on average (median)
bisphenol A in sediments shows, however, that the che-
6 µg/kg sediment (related to wet weight). 5% of all se-
mical is still not completely degraded and that residues
diments contain, from a statistical point of view, more
remain in water bodies.
than 98 µg bisphenol A per kilogram sediment.
Contamination of municipal sewage plants can be
A government monitoring programme concerned with
explained with the example of recycled paper: waste
substance concentrations in selected rivers from 2002
paper that is used for the manufacture of recycled pa-
to 2007, in accordance with the EU Water Framework
per also contains, despite thorough sorting processes,
Directive , confirmed these results: On average,
thermal paper. This, in turn, contains bisphenol A. The
0.05 µg/l bisphenol A (median) was found in the waters
proportion of thermal paper in processed paper is on
under investigation. Merely in five of 1,230 samples
average just about 0.1%, but, depending on the end
was no bisphenol A found. In the investigated German
product, it can fluctuate greatly . One possible end
flowing waters the highest concentration was 5.2 µg/l,
product is recycled toilet paper. With wastewater it en-
on yearly average a maximum of 0.49 µg/l (2007, yearly
ters municipal sewage plants and brings with it bisphe-
average value of the measuring station with the high-
nol A, which, in the case of insufficient degradation,
est values). The federal states carried out the required
then enters into water bodies. The relevance of this
measurements in the period from 2006 to 2008.
mass flow is still unclear.
These measurements substantiate the occurrence of
Bisphenol A residues can also remain in sludge that
bisphenol A in the environment. Since single data coll-
is produced in paper recycling. If this sludge is used
ections are involved, and no time series, the measure-
for farmland fertilization, as is common in certain
ments do not allow an assessment of the concentration-
European countries, bisphenol A enters into the soil.
time course. Assignment to individual sources is also
In Germany and Austria this sludge is burnt. Sewage
difficult. For the EU Risk Assessment Report [5; 6] expec-
sludge from municipal sewage plants, which is also
ted water and sediment concentrations were therefore
used in Germany as a fertilizer, might also contain
calculated on the basis of data on degradation and
bisphenol A. The Federal Environment Agency, howe-
distribution in the environment. The values thus cal-
ver, has no measurements concerning this at its dispo-
culated are 0.03 µg/l on average and 1.47 µg/l at most
in water. Measured environmental concentrations are therefore, in part, above the calculated values. As far as
Furthermore, bisphenol A can enter the environment
sediment is concerned, the EU Risk Assessment Report
through the use of products made of PVC (for examp-
calculated 0.52 µg bisphenol A per kilogram sediment
le, external cables). The EU Risk Assessment Report on
on average and 24 µg/kg sediment at most.
bisphenol A makes certain assumptions in this respect
. The quantity that is discharged into the environ-
What is the effect of bisphenol A on humans and the
ment cannot, however, be reliably estimated.
Concentrations in the environment
Mechanisms of hormone action
Evidence for the presence of bisphenol A in water bo-
The mechanisms of hormone action induced by bisphe-
dies and river sediments has been provided since the
nol A is in the focus of public attention (for example:
1970s (inter alia [41-43]). Scientific publications as well
[20; 45; 46]). Substances interfere with the hormonal
as government monitoring programmes have confir-
system can – if they enter the body in a sufficient con-
med the widespread occurrence of bisphenol A in wa-
centration – change the hormone system, disrupt em-
ter bodies in recent years.
bryonal development and impair reproduction . In science, such substances are named environmental hor-
The EU Risk Assessment Report consolidates numerous
mones or endocrine disrupters . In the same way
scientific publications concerning the occurrence
as natural hormones, many of these substances attach
of bisphenol A in European waters during the years
to „docking sites" (receptors) for natural sex hormones
1997 to 2005 . It took into account several hundred
and activate or hinder these receptors. As a result they
measuring stations in 13 countries. Bisphenol A was
influence processes that are normally triggered by na-
detected in half of the measurements (detection limits,
tural hormones (for example, sexual development). Fish,
depending on method, between 0.1 and 0.00004 µg/l).
for example, can feminize when they ingest substances
The highest concentration, 43 µg/l, was measured in
that activate the receptor of the natural female sex hor-
a Norwegian water body that is located close to an in-
dustrial centre. From the data, the EU Risk Assessment
In the case of bisphenol A, investigations show that it
(see Box 4). The hormonal systems of these organisms,
strengthens the effect of female sex hormones and wea-
however, are as yet insufficiently researched to enable
kens male sex and thyroid hormones [49; 50]. In certain unequivocal statements on the mechanisms of action.
test systems, in particular with non-genomic effects that are imparted by way of the membrane oestrogen
Can bisphenol A affect our health?
receptor, bisphenol A has an effect that is almost just
The European Food Safety Authority (EFSA) is of the
as strong as that of the natural female sex hormone
opinion that bisphenol A does not represent a risk to
human health. This assessment is based on studies with rodents that are regarded as highly relevant. Their re-
With humans, the oestrogen-type effect is triggered
sult: Harmful effects relevant to the assessment below
only by a free, non-metabolized substance. Though
an intake of 5 milligrams per kilogram body weight per
bisphenol A is rapidly metabolized – in part, already in
day cannot be established. According to EFSA, the daily
the intestine – to bisphenol A glucuronide and bisphe-
human intake remains well below the tolerable daily
nol A sulphate, in human tissues such as testicles and
intake of 50 µg per kilogram body weight derived from
the placenta the active form of bisphenol A can be
studies with rodents. On the other hand, numerous
released . Almost all studies that investigate human
authors report of the effect of much lower doses of
blood have found relevant concentrations of non-meta-
bisphenol A on reproductive health parameters and
bolized bisphenol A .
development . Due to varied criticism of the stu-dies, however, low-dose effects on individual organs
The mechanisms of hormone action induced by
and fertility were not taken into account by European
bisphenol A also cause damage in animals (for ex-
authorities for the assessment. The Federal Government
ample fish and birds). This is confirmed in numerous
commented on this in detail during the last legislative
studies, which have been condensed in a report of the
American Environmental Protection Agency (EPA) . They show that in different animal species bisphenol
These investigations do, however, point to possible ef-
A attaches to the receptor for female sex hormones
fects of bisphenol A (for example, certain changes in
(oestrogenic receptor), activates it and triggers effects
behaviour), which are not recorded in studies that con-
that are to be expected with such an effect mechanism
form to standardized test procedures.
(for example, malformation of the reproductive organs). More than 100 investigations with rats and mice indi-The results of a number of studies are summarized in
cate that low concentrations of bisphenol A affect beha-
Box 4. In comparison to the highly-potent natural sex
viour, learning ability and certain brain structures, in
hormone oestradiol, however, concentrations 100 to
particular in the offspring of exposed animals. Prostate
10,000 times higher would be necessary to trigger the
enlargement, reduced sperm concentrations and early
puberty were also observed in laboratory animals [26; 55]. These studies support the hypothesis that bisphe-
The effects observed with insects, snails and crustaceans nol A could affect sex-specific brain and organ develop-(for example, effect on egg production or the timing
of hatching) indicate that bisphenol A has an adverse effect on the hormone-controlled reproductive system
With no other chemical is the quality of studies the
BOX 4 Summary of the results of different studies on the mechanisms of hormone action induced by bisphenol A of bisphenol A (modified in
accordance with )Organism group
Observed effects in the organism
Activation of the oestrogen
receptor, effects on thyroid hormones
Attachment to the oestrogen
Malformation of reproductive organs
Activation of the oestrogen
Malformation of reproductive organs,
decline in sperm quality, retardation of sperm maturity, shifting of the gender ratio
Not clearly known
Increased egg production, malformation of the reproductive organs of females and males
Not clearly known
Increased egg production
Not clearly known
subject of such controversial debate as in the case of
Assessment Report on bisphenol A.
bisphenol A. Not only investigations that establish health effects of low doses in test animals, but also
The findings in the EU Risk Assessment Report on
studies that find no adverse effects are contested. One
bisphenol A, as well as unconsidered, unverified effects
example is the discussion concerning the latest study
are displayed in Box 5.
from Ryan et al. [56-58]
Assessment of risks for humans
Bisphenol A leads in isolated cases to sensitization
The assessment of possible health risks from bisphe-
in humans, which indicates an allergenic potential.
nol A have been the subject of controversial debate
Different studies have recently described how links exist for years. The EU Risk Assessment Report on bisphe-between exposure to bisphenol A and development
nol A, in accordance with the EU Existing Substances
disorders and illnesses. For example, men who work in
Programme (ESP), comes to the conclusion – as does
factories that process bisphenol A increasingly suffer
the European Food Safety Authority – that there is no
from erectile and ejaculation problems as well as from
cause for concern on the part of European consumers
libido disorder. This is all the more striking since the
that a health hazard exists when products containing
content of bisphenol A in the blood of the men in que-
bisphenol A are properly used , . The Federal
stion was on average just 5% of the level that is regar-
Institute for Risk Assessment (BfR), which is responsible
ded by the European Food Safety Authority as harmless. for food safety and consumer protection in Germany, At the same time, the bisphenol A content in the blood
shares this view.
of the workers was more or less in the range that was found in a number of German children and adolescents Individual European countries do not, however, rule . On the other hand, no reproductive disorders were out health risks from the chemical. Against the back-es-tablished in woman that have occupational contact
drop of uncertainties in the EU Risk Assessment Report,
to bisphenol A .
these countries stress the necessity to introduce further precautionary legal measures. Due to the effects on
The daughters of women who were subject to higher
reproduction Norway intends to restrict the content
exposure to bisphenol A during pregnancy display at
of bisphenol A in consumer products to 0.0025% by
two years of age a more aggressive behaviour than
weight . In March 2010 Denmark enacted a tem-
their contemporaries .
porary ban on products that can release bisphenol A and have contact to food for children . This con-
Those sections of the American general population that cerns food packaging, children‘s beakers and children‘s are subject to greater exposure to bisphenol A suffer
more frequently from diabetes and respiratory illnesses [61; 62]. Similarly, higher concentrations of bisphenol A In France, in March 2010, the Senate unanimously have been found in the bodies of women suffering from passed a bill that prohibits drink bottles manufactured endometriosis (endometrial excrescences) . It is
on the basis of bisphenol A. Before enactment, the bill
unclear, however, whether increased bisphenol A values requires the assent of the National Assembly, the se-are the cause or the consequence of these illnesses.
cond chamber of the French parliament .
What are the effects of bisphenol A on aquatic and soil
In its report published in 2008, the US Food and Drug
Administration (FDA) took the view that there were
Scientists have thoroughly investigated how different
no health risks . It has, however, recently revised
aquatic and soil organisms react to bisphenol A. The
its opinion. Due to concern that even in small doses
results of their studies are summarized in the EU Risk
bisphenol A could damage health, the FDA is taking
Assessment Report on bisphenol A [5; 6] and displayed
reasonable steps to reduce human exposure. It intends,
in particular, to reduce the bisphenol A content in children‘s food and bottles . The assessment of the
The results of these investigations are not easy to as-
US National Toxicology Program  also expressed
sess. They show unequivocally that bisphenol A impairs
„some concern" regarding adverse effects on the brain
the sexual development and reproduction of different
and behaviour, as well as on the prostate glands of
animal species. It is unclear, however, at which con-
foetuses, infants and children. It expressed „minimal
centrations these effects occur. Isolated tests provide
„concern" over other health effects in these sections of
indications that the development and reproduction
the population .
of frogs, snails and fish are impaired even by very low concentrations of bisphenol A. Since these tests have
Individual EU Member States, Canada and several states
methodical failings, the EU Risk Assessment Report did
in the USA regard measures as necessary. In several ci-
not include their findings. The tests imply, however,
ties and states in the USA, bans on baby bottles that re-
that the effect of bisphenol A on aquatic and soil orga-
lease bisphenol A are in force or the subject of legislati-
nisms is possibly underestimated in the current EU Risk
ve procedures (inter alia Chicago, Minnesota, Michigan,
BOX 5 Effects on aquatic organisms [5; 6] The concentrations are listed, at which no effects were observed (no observed effect concen-tration, NOEC) in the test, as well further indications that were not taken into account in the EU Risk Assessment Report for bisphenol A.
16 – 3.640 µg/lIndications that sperm quality is already reduced at 1.75 µg/l
60.4 µg/lIndications from one test that the gender ratio might already be shifted at 2.3 µg/l
Insects and crustaceans
100 – 3,146 µg/l
EC10* = 2.1 µg/l Indications that effects on reproduction already occur with considerably lower concentrations (factor 10 - 1000)* EC10 can serve as a substitute for NOEC, and describes the concentration at which effects are shown in 10% of animals
Algae and aquatic plants
1,360 and 7,800 µg/l
Further species (cnidarians and sponges)
42 and 1,600 µg/l
Soil organisms (earthworms, springtails, plants)
20 to more than 100 mg/kg soil
California, Connecticut and Washington). Canada has
clusions. Due to the mechanisms of hormone action
banned baby bottles containing bisphenol A . The
and high toxicity for aquatic organisms, both countries
Canadian Government explained its ban with the pre-
plan measures – on the basis of national legislation – to
cautionary principle, and announced further research
reduce the discharge of bisphenol A into the environ-
projects to close existing knowledge gaps.
ment [40; 65].
Assessment of risks to the environment
What happens next?
The updated EU Risk Assessment Report on bisphenol
The EU Chemicals Regulation REACH (Registration,
A of 2008  comes to the conclusion that calculated
Evaluation and Authorisation of Chemicals)  impo-
concentrations in the environment are well below the
ses an obligation on manufacturers and importers of
levels at which effects on soils and aquatic organisms
chemicals. It requires that companies that manufactu-
are to be expected. The risk is held to be tolerable; no
rer or import bisphenol A assess the risks for humans
measures have to be taken to reduce concentrations (so-
and the environment of all intended uses of bisphenol
called „risk reduction measures") in the environment
A. By the end of 2010 they must document their assess-
ment in a chemical safety report and, at the same time, look into the indications of underestimation of risk rai-
The Risk Assessment reveals, however, some uncertain-
sed by the United Kingdom. It is the duty of companies
ties. The United Kingdom summarized them at the con-
to describe the conditions under which bisphenol A
clusion of work in the Existing Substances Programme
can be safely used over its entire life cycle. Where ne-
cessary, they have a duty to apply and recommend risk reduction measures.
• Further information is necessary, in order to clarify
whether bisphenol A has an effect on aquatic orga-
The chemical safety report together with other infor-
nisms at lower concentrations than previously assu-
mation enable the authorities to decide whether they
med. (see Box 5).
regard additional measures for the protection of hu-
• Concentrations measured in the environment pro-
mans and the environ-ment to be necessary. Differences
vide indications that the values calculated for the
between REACH and the Regulation on Existing Sub-
Risk Assessment underestimate the exposure of
stances , as well as the duties of companies and autho-
water bodies (see chapter: „Concentrations in the
rities, are displayed in Box 6. A harmonised position
exists on further action on the part of the Federal
Government [55a; 74a].
Japan also comes to the data-based conclusion that bisphenol A represents no risk to the environment, and that no regulatory measures are necessary . Norway and Canada, however, reached different con-
Federal Environment Agency evaluation of risks to human
in particular, to products that come into contact with
food. For these products there are additional regulatory
The overall picture provided by available studies on the
options beyond chemicals law (REACH).
effects of and exposure to bisphenol A reveals indica-
As far as regulatory options are concerned, a distinc-
tions of possible risks to human health. There are pre-
tion has to be made between food packaging materials
sently still distinct gaps in knowledge and uncertainties and products, such as baby bottles, which come into with regard to certain aspects of risk assessment. In the direct contact with food, and other articles that inevi-view of the Federal Environment Agency it is therefore
tably come into contact with the mucous membranes
justified to consider precautionary measures to reduce
of the mouth, such as dummies.
the exposure of those sections of the population that
Legal specifications for both groups of products mainly
on account of their sensitivity and exposure are prima-
result from European legislation. National measures
rily at risk.
may only be introduced when permitted by European law.
The workshop on the assessment of bisphenol A, which was organized by the Federal Environment Agency
European regulations on food packaging and storage
in March 2009, recommended that all available data
products are by and large final. There is therefore little
be drawn on by the authorities for the assessment of
legislative leeway for German legislators. Efforts to-
the substance. The numerous studies that have been
wards lowering upper limits on the presence of bisphe-
published in renowned journals provide a consistent
nol A in food packaging and storage containers made
picture. Their findings should be properly considered
of plastic, such as bottles, have therefore to be initially
in addition to the few investigations that have been
undertaken at the European level.
carried out in accordance with the principles of good laboratory practice .
If the EU cannot reach agreement on a common ap-proach, Member States still have the opportunity to
In these studies, the intake of bisphenol A is consi-
take provisional measures regarding food packaging
derably below the quantity that the European Food
and storage products. That could be the case if Member
Safety Authority assesses to be a risk to health; these
States come to the conclusion, on the basis of new in-
quantities are nevertheless able to cause serious adverse formation or through the reevaluation of existing infor-effects in animals.
mation, that human health could be endangered. New information and knowledge concerning bisphenol A
Although gaps in knowledge exist with regard to risk
must therefore be examined, to establish whether this
assessment and level of exposure, from our scientific
requirement is met. Separate national regulations can
point of view there are sufficient grounds for concern.
only endure if the European Commission adopts the
The Federal Environment Agency is therefore in favour
of precautionary action and restrictions on the use of certain products that contain bisphenol A. This applies,
BOX 6 Duties of authorities and companies (comparison of the Regulation on Existing Substances and REACH)
Council Regulation (EEC) No. 793/93 on existing substances (repealed on 01.06.2008)
Submit available information and comment on
Assess the risk to humans and the environment
assessments of authorities
of selected substances that are produced in large quantities (including bisphenol A) and decide, where appropriate, on necessary measures to reduce risks.
REACH Regulation (EEC) No. 1907/2006 (since 01.06.2007)
Assess the risk to humans and the environment
Reevaluation of selected risk assessments. Decide
under their own responsibility, determine possibly
whether risk reduction measures are necessary that go
necessary measures for the reduction of risk, apply
beyond those applied by companies. Possible measures
such measures and pass on relevant information to
are restrictions on individual uses or authorization.
downstream users. The objective is to guarantee safe
A restriction can be effected if a substance poses
use throughout the entire life cycle of a substance.
an unacceptable risk to human health or the environment. For authorization, the authorities must identify the substance community wide in accordance with certain criteria as a substance of very high concern (SVHC).
In contrast to measures concerning food packaging
must be to reduce the discharge of bisphenol A into
products and storage containers (for example, bottles),
the environment as far as possible.
in the case of articles such as dummies national bans cannot be enacted; at the most, more stringent upper limits can be imposed.
Until the introduction of far-reaching legal regulations, the product responsibility of manufacturers is particu-larly important. The debate on the risks of bisphenol A had the effect in the USA that the five largest manuf-acturers of baby bottles voluntarily renounced the use of polycarbonates. We propose that in discussions with manufacturers the attempt be made to achieve the same level of protection for small children, initially on a voluntary basis in Germany. The chances are not bad, since some of the American companies are also the largest suppliers in Germany.
Federal Environment Agency evaluation of risks to the
In the view of the Federal Environment Agency, the
EU Risk Assessment Report, in accordance with the
Regulation on Existing Substances, describes the risks
of bisphenol A to the environment [5; 6], as well as the
uncertainties associated with the assessment in the esti-
mation of environmental concentrations and adverse
effects on the reproductive system of different animals
, in a well-founded and balanced manner. Due to
uncertainties, available information does not at present
enable final assessment of the risks to the environ-
ment; it does indicate, however, that the risk to the en-
vironment is probably underestimated.
In accordance with REACH, the responsibility now lies with manufacturers and users of bisphenol A. Their chemical safety assessment must cover, by 2010, all cur-rent uses and therefore go beyond the previous assess-ment in accordance with the EU Existing Substances Programme. In their chemical safety assessment com-panies must take into consideration the high measured environmental concentrations described in the Chapter „How does bisphenol A enter the environment", and clear up the related uncertainties documented by the United Kingdom. The effects on snails and fish must also be reevaluated as soon as new data becomes avai-lable.
As soon as the registration dossier is available, the Federal Environment Agency will check company results. Particular attention will be paid to the assess-ment of exposure, and to new data on bisphenol A and aquatic organisms. The Federal Environment Agency will then decide whether, from a scientific point of view, additional legal measures in accordance with the REACH Regulation are necessary for risk reduction and, where appropriate, propose such measures. The Federal Environment Agency advises manufacturers, importers and users of bisphenol A to replace potentially proble-matic products with safer alternatives. The objective
a consistent picture, so that despite uncertainties and
Bisphenol A is found in many everyday products. The
gaps in knowledge concerning risk assessment and the
largest portion of manufactured bisphenol A is conver-
level of exposure there is a need for action. The UBA
ted into stable plastics (polycarbonate and epoxy re-
is therefore in favour of precautionary action and re-
sins). Under certain conditions, the chemical can be re-
strictions on the use of certain products that contain
leased from consumer products – from can coatings, for bisphenol A. instance – and enter the human body by way of food or through the skin, from thermal paper for example. In
The EU also regards the risk to the environment as to-
the human body the substance can act like the female
lerable. Calculated concentrations in the environment
sex hormone oestrogen.
are noticeably below the level at which effects on soil and aquatic organisms are to be expected. At the same
Bisphenol A also enters into the water cycle and thus
time, different studies provide evidence that the risk to
the bodies of aquatic organisms. Measurements in re-
aquatic and sediment organisms has possibly been pre-
cent years have confirmed the presence of bisphenol A
in many water bodies. The substance originates mainly from the wastewater treatment plants of companies
Under the terms of the European Chemicals Regulation
that produce and process bisphenol A.
REACH, manufacturers and users of bisphenol A are obliged to exercise their own responsibility. They have
Is there a risk to humans and the environment? Are le-
to describe the conditions under which bisphenol can
gal measures therefore necessary for protection against
be safely used over its entire life. Where necessary, they
have to apply risk reduction measures for this purpose.
Numerous studies have shown that bisphenol A dis-
On the basis of such information the Federal
rupts the hormonal system of mammals and aquatic
Environment Agency will re-evaluate the assessment of
organisms. There are analyses that prove that even in
risk to the environment from bisphenol A. The Federal
low concentrations the chemical has a negative effect
Environment Agency will then decide whether from a
on sexuality, and that also establish a connection with
scientific point of view additional legal measures are
the occurrence of diabetes and respiratory illnesses.
necessary, which should be recommended to the EU for
Moreover, there are indications that bisphenol A can
risk reduction in the environment. At the same time,
influence the development of mental abilities and be-
possible product-related regulations for consumer pro-
haviour, as well as encourage aggression and hinder
ducts should be considered. As a basic principle, the
learning. The scientific findings that are presently avai-
Federal Environment Agency recommends that the con-
lable are, however, not without inconsistencies. Many
tent of bisphenol A in products be further restricted. In
studies are the subject of controversial debate among
addition, the Agency advises manufacturers, importers
and users of bisphenol to use alternative substances that pose less risk to human health and the environ-
Studies have also established that with certain animal
ment in all areas of use that significantly contribute
species (snails, for example) bisphenol A, even in very
to exposure. This way, an important contribution can
low concentrations, disrupts reproduction. The evaluati-
be made to product responsibility in the case of a sub-
on of these results is contested, however, since many of
stance for which precautionary protection of humans
the tests have methodical failings.
and the environment is advisable.
In accordance with Council Regulation (EEC) No. 793/93 on existing substances, and within the scope of the EU Existing Substances Programme, Member States have assessed the risk of bisphenol A for humans and the environment. The result was that the majority of Member States concluded that with proper use of products containing bisphenol A there was no cause for concern about health risks. The European Food Safety Authority (EFSA) also came to the same con-clusion. However, not all EU countries came to such an unequivocal conclusion. Denmark and France, for instance, have enacted further precautionary measu-res for certain products, while Canada has banned baby bottles containing bisphenol A on precautionary grounds. From the point of view of the German Federal Environment Agency (UBA) there are sufficient grounds for concern. Numerous studies present on the whole
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 ASSEMBLÉE NATIONALE. (2010). PROPOSITION DE
LOI ADOPTÉE PAR LE SÉNAT, tendant à suspendre la commercialisation de biberons produits à base
Level 4 Potential Conservation Area (PCA) Report Site Code Site Class Site Alias Network of Conservation Areas (NCA) NCA Site ID NCA Site Code NCA Site Name 7,960.00 Feet 8,600.00 Feet 2,621.28 Meters Centrally located in Jefferson County, this site includes a rich forested area in the montane zone with steep and rugged topography. It includes a number of small first order streams that flow north into Casto Creek which follows Kennedy Gulch. The north-facing slopes and drainages contain a diverse array of plant species including many state rare plants. The habitats are varied with willow carrs and wet meadows dominating the vegetation along Casto Creek. The willow community is very thick in some areas along Casto Creek especially further from the roadway. Coyote Creek, one of the north-facing drainages, is an excellent example of a lightly impacted first order stream. The north-facing aspect has likely contributed to the very high biodiversity of the drainage. Blue spruce (Picea pungens), thinleaf alder (Alnus incana) and mature quaking aspen (Populus tremuloides) are the dominant tree species along the drainage. The intact floodplain of the upper reaches of Coyote Creek was especially rich in herbaceous growth with a very low presence of non-native plants. The upland vegetation consists of forested hillsides with ponderosa pine ( Pinus ponderosa), Douglas-fir (Pseudotsuga menziesii) and a rich herbaceous layer in the moist shady areas that included Canada violet (Viola rydbergii), Fendler's waterleaf (Hydrophyllum fendleri), starry false lily of the valley (Maianthemum stellatum), musk-root (Adoxa moschatellina), fairy slipper orchid (Calypso bulbosa), Hall's ragwort (Ligularia bigelovii var. hallii), roughleaf ricegrass (Oryzopsis asperifolia), Rocky Mountain sedge (Carex saximontana), blue clematis (Atrogene occidentalis), Hudson Bay anemone (Anemone multifida subsp. globosa), alpine milkvetch (Astragalus alpinus), wood lily (Lilium philadelphicum) and beautiful cinquefoil (Potentilla pulcherrima). The most common upland soils are the Grimstone-Hiwan-Rock outcrop complex, 30-70 percent slopes with lesser amounts of Legault-Hiwan stony loamy sands, 15-30 percent and Rogert-Herbman-rock outcrop complex, 30-70 percent slopes. The soils in the wetland areas and along Casto Creek drainage consist of Rosane-Venable fine sandy loams, 0-3 percent slopes. The soils along Coyote Creek consist largely of Kittredge-Venable complex with 0-5 percent slopes (USDA NRCS 2008). The geology consists of igneous granitic rocks that are 1, 350-1,480 million years old (Tweto 1979).
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