Bisphenol a - an industrial chemical with adverse effects

BISPHENOL A
Massenchemikalie mit
BISPHENOL A
An industrial chemical with
Published by:
Umweltbundesamt
(German Federal Environment Agency)
Press Office, Wörlitzer Platz 1,
06844 Dessau-Roßlau, Germany
Updated version July 2010
Design: UBA
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 [5], 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 [6]. 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 [7]. 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) [3], 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 [10].
BOX 1 Explanation of the chemistry of bisphenol A Chemical name: 2,2-Bis-(4-hydroxyphenyl)propane
Molecular formula: 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 polymer matrix.
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] Polycarbonate plastics
• 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 Epoxy resins
• 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 [12].
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 [5]. 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 [9]. 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 [9],[14]; 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) [9].
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 [16].
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- [13]. Bisphenol A serves here as developer substance tardant [5]. In the environment, TBBPA can reconvert to alongside the actual dye. It is worldwide the most com- bisphenol A (reductive halogenization) [5], [17].
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 [23]. Consumption of flame retardants in the cash register receipts) [6; 9; 13] EU amounted in the year 2006 to 465.500 tonnes [24].
• 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 [6]). 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 [5] 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 [6] 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.
flame retardant.
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 [25] each year in products treated den hoses and nail varnish [20].
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 [6].
3.8 million tonnes of bisphenol A [21]. 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 [6]. 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 [22]). 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 [26]. 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: [6]) Polycarbonate (80%) 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 [27].
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 [28]. 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 [29], health cannot be reliably assessed.
as well as on the detergents used [30]. 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) [35], [36]. For bottle-fed infants the value dialysis treatment and in newborn intensive care units is 0.8 µg/kg bw/day [35]. Scientists have identified the [32; 33]. Increased concentrations of bisphenol A in the highest daily intake by children as 7 µg/kg bw/day [36] human body have also been measured at workplaces in (median implies that half of the investigated samples the production and processing of bisphenol A [6].
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 pathways [22].
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) [34].
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 [6]. 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 [6].
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 [37]. 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 [12]) and by commissio- vary greatly. They established an average degradation ning qualified pipe installers. Under these conditions, rate of 68 % [40]. 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 [44], 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 [6]. 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 [5]. 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 [47]. In science, such substances are named environmental hor- The EU Risk Assessment Report consolidates numerous mones or endocrine disrupters [48]. 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 [6]. 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- mone oestrogen.
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 [67,68] [51].
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 [52]. 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 [53].
development [55]. 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 period [55a].
American Environmental Protection Agency (EPA) [54]. 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 same effect.
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 [54])
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 Retarded hatching 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 [6], [64]. 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 [28]. 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 [59]. 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 [65]. In March 2010 Denmark enacted a tem- their contemporaries [60]. porary ban on products that can release bisphenol A and have contact to food for children [66]. 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) [63]. 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 [67].
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 [68]. 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 [69]. The assessment of the The results of these investigations are not easy to as- US National Toxicology Program [70] 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 [70].
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 [71]. 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 [6] comes to the conclusion that calculated Evaluation and Authorisation of Chemicals) [74] 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 [73]. 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 [22]. 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)
Companies
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)
Companies
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
environment
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
[72], 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 viously underestimated. 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 [1] Dodds E.C., Lawson W. (1935). Molecular structure [16] Vandenberg L.N., Hauser R., Marcus M., Olea N., in relation to oestrogenic activity. Compounds wi- Welshons V.W. (2007). Human expo-sure to bisphe- thout a phenanthrene nucleus. Proceedings of the nol A (BPA). Reprod Toxicol 24: 139-177. Royal Society 125 (839): 222-232. [17] Voordeckers J.W., Fennell D.E., Jones K., Häggblom [2] Dodds E.C., Lawson W. (1936). Synthetic estrogenic M.M. (2002).
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