Migration of bisphenol A from cash register receipts and baty dummies

Migration of bisphenol A from cash

Carsten Lassen, Sonja Hagen Mikkelsen and

Ulla Kristine Brandt

COWI A/S

Survey of Chemical Substances in Consumer

Products, No. 110 2011

The Danish Environmental Protection Agency will, when opportunity

offers, publish reports and contributions relating to environmental

research and development projects financed via the Danish EPA.

Please note that publication does not signify that the contents of the

reports necessarily reflect the views of the Danish EPA.

The reports are, however, published because the Danish EPA finds that

the studies represent a valuable contribution to the debate on

environmental policy in Denmark.

Content

PREFACE 5

SUMMARY 7

1 INTRODUCTION 11

1.1 IDENTIFICATION OF THE SUBSTANCE 11

1.2 BPA IN THERMAL PAPER 11

1.3 BPA IN POLYCARBONATE 12

1.4 PREVIOUS STUDIES 13

1.4.1 BPA in thermal paper 13

1.4.2 BPA in polycarbonate 15

2 MAPPING 17

2.1 CASH REGISTER RECEIPTS 17

2.1.1 Information from suppliers and manufacturers 17

2.2 BABY DUMMIES 19

2.1.1 Information from manufacturers and retailers 20

2.2.1 Dummies sold via the Internet 20

2.3 SUMMARY 20

3 EXPOSURE SCENARIOS 23

3.1 CALCULATION OF CONSUMER EXPOSURE 23

3.2 CASH REGISTER RECEIPTS 23

3.2.1 Determination of exposure parameters for consumer exposure 26

3.3 BABY DUMMIES 30

3.3.1 Dermal exposure 30

3.3.2 Oral exposure 32

4 ANALYSES 35

4.1 COLLECTION, METHODS OF ANALYSES AND TEST DESIGN 35

4.1.1 Cash register receipts 35

4.1.2 Dummy shield 37

4.2 RESULTS OF ANALYSIS 38

4.2.1 Cash register receipts 38

4.2.2 Shield on baby dummies 43

5 HEALTH ASSESSMENT 45

5.1 BASIS OF THE TOXICOLOGICAL ASSESSMENT 45

5.1.1 Effect levels and DNEL 45

5.1.2 Absorption of BPA after dermal exposure 46

5.2 CASH REGISTER RECEIPTS 47

5.2.1 Exposure 47

5.2.2 Health risk assessment 48

5.3 DUMMIES 51

5.3.1 Exposure 51

5.3.2 Health risk assessment 53

5.4 SUMMARY AND CONCLUSION 54

REFERENCES 57

APPE

NDIX 1 KOEHLER’S ASSORTMENT OF THERMAL PAPER 61

APPENDIX 2 MITSUBISHI’S ASSORTMENT OF THERMAL PAPER63

APPENDIX 3 DUMMIES SOLD IN DANISH INTERNET SHOPS 65

Preface

Bisphenol A (BPA) has been classified an endocrine disruptor, but the experts

disagree on which concentrations it would take before these effects occur. The

substance has great political and public attention especially because BPA is in

food packaging and baby bottles. A preliminary ban has been imposed in

Denmark against BPA in materials touching food for the 0-3 year-olds and

EU has just agreed on a ban against BPA in baby bottles for the 0-1 year-olds.

Exposure of consumers and cashiers from BPA in cash register receipts made

of thermal paper has until recently not had much attention and is not included

in the EU risk assessment of BPA. Within the last 6 months new information

and data have been published causing doubt whether migration of BPA from

receipts could have damaging health effects.

This study has been initiated by the Danish Environmental Protection Agency

with the aim of:

 illustrating whether migration of bisphenol A from receipts creates a

health problem for Danish consumers and

 illustrating whether migration of bisphenol A from the shield of baby

dummies on the Danish market constitutes a health risk for the 0-3 year-

olds.

The project has been carried out in autumn 2010. During the project period a

number of studies have been published reviewing the possible migration of

BPA in cash register receipts. Studies which have been available before 12

November 2010 are included in the discussion of the results of this study.

Steering committee

The project

has been followed by a steering committee with following mem-

bers:

Karina L. Vintersborg, Danish Environmental Protection Agency (Chairman)

Shima Dobel, Danish Environmental Protection Agency

Carsten Lassen, COWI

Sonja Hagen Mikkelsen, COWI

Project group

The study

was made by a team consisting of Carsten Lassen (project man-

ager), Sonja Hagen Mikkelsen and Ulla Kristine Brandt, COWI A/S. Analysis

of BPA in products and release of BPA from the products have been carried

out by Danish Technological Institute with Ulla Christensen as contact per-

son.

Summary

Based on an analysis of consumers’ exposure to bisphenol A (BPA) emitted

from cash register receipts and other receipts of thermal paper, the daily up-

take of BPA from these sources has been calculated in a realistic worst case

scenario to be approx. 0.24 mg BPA. In this scenario it is assumed that the

receipts are touched with humid fingers and that 50% of the quantity left on

the skin is absorbed. With this scenario the exposure will be approx. 1/5 of the

Derived No Effect Level (DNEL). As a worst case scenario has been used,

the actual exposure of the general consumer in most cases will be considerably

lower. A realistic worst case scenario for cashiers also shows a calculated up-

take below the DNEL value.

Based on analyses of migration of BPA from baby dummies with a shield of

polycarbonate, the maximum daily uptake of BPA has been calculated to be

far below the level where damaging health effects are expected.

The aim of this study is to illustrate to which extent releases of bisphenol A

(BPA) from cash register receipts constitutes a health problem for Danish

consumers and to investigate whether the releases of bisphenol A from the

shield of baby dummies made of polycarbonate is a health risk for 0-3 year old

children.

BPA in cash register receipts ticket

Based

on contacts with Danish suppliers of cash register receipts it is assumed

that 90% of cash register receipts in Denmark are made of thermal paper. It is

also assumed, based on general EU figures, that 70-80% of the receipts are

made of thermal paper containing BPA. BPA is used as a developer in the

process of colouring the paper when heated.

12 printed cash register receipts have been analysed in this study covering re-

ceipts from different types of shops, cash point machines and a library. Apart

from this, a test sample of a sticker from weighing vegetables in a supermarket

has been analysed. The content of BPA in 7 out of 12 analysed cash register

receipts varied from 8,700 to 17,000 mg/kg (see Table 1). There is no corre-

lation between the quantity of BPA in the cash register receipts and the mi-

grating quantity. The concentrations found are in accordance with what has

been found in other surveys. Based on Swedish studies and information from

suppliers of thermal paper, it is estimated that thermal paper containing BPA

is also used for a number of other purposes such as tickets, boarding cards,

queue tickets, parking tickets and various printer and recorder papers.

Bisphenol S (BPS) was found in three of the cash register receipts. BPS is

typically used instead of BPA in more resistant receipts from cash point ma-

chines and shops where it is expected that the receipt could be saved for many

years. Two contained neither BPA nor BPS, but the actual substances were

not determined. There are several types of thermal paper on the market where

the developers are not based on phenol chemicals, but it has not been possible

to find out which developers are used instead.

In order to e

xamine to which extent consumers are exposed to BPA from the

receipts, analyses were carried out of the migration of BPA to artificial sweat

and of the quantity released to fingers when handling the tickets.

Immersion of the cash register receipts in artificial sweat for 5 seconds showed

a migration from the receipts of 7-21µg BPA/cm

, equivalent to 10-37% of the

content of BPA in the receipts. There were no relation between the content of

BPA in the receipt and the migrated quantity, and none of the cash register

receipts were significantly different from the others in regard to releases of

BPA from the receipt.

Based on this test, four cash register receipts were selected for at test imitating

a realistic handling situation of a receipt. The tests showed significant differ-

ences in the migrated quantities depending on whether the fingers were dry

(with natural humidity), humid or with lotion. The average quantity of BPA

left on the fingers in the three situations was 11, 103 and 28 µg BPA respec-

tively. The values equal results from a Swiss study published in 2010.

Table 1

Content of BPA in cash register receipts, exposure to fingers and artificial sweat

Content of BPA BPA exposure

to artificial

sweat, 5 sec

BPA exposure to fingers, µg Place of sampling

mg/kg µg/cm

µg/cm

** Dry fingers Humid

fingers

Fingers with

lotion

Petrol station 1

(payment machine)

1.4 0.011 n.a. n.a. n.a. n.a.

Petrol station 2

(payment machine)

b.d. * b.d. n.a. n.a. n.a. n.a.

Furniture chain b.d.* b.d. n.a. n.a. n.a. n.a.

Toy shop 8,700 46 13 4.6 21 n.a.

Supermarket chain 1 9,300 61 11 5.4 240 n.a.

Supermarket chain 2 11,000 51 19 30.0 64 26

Discount super market 1 17,000 77 21 5.3 88 30

Discount super market 2 10,000 48 13 n.a. n.a. n.a.

Bank (cash machine) b.d * b.d n.a. n.a. n.a. n.a.

Library 9,700 53 13 n.a. n.a. n.a.

Discount super market 3 14,000 64 7 n.a. n.a. n.a.

Hardware store 37 0.19 n.a. n.a. n.a. n.a.

Supermarket chain, sticker b.d * b.d * n.a. n.a. n.a. n.a.

Average ** 11,400 57 14 11 103 28

* Contained BPS, quantity of BPS not determined.

** The two lowest values of 1.4 and 37 mg/kg (0.011 and 0.19 µg/cm

) are not included when

calculating the average.

n.a. Not analysed.

b.d. Below the detection limit for bisphenol A, which in this study is 0.1 mg/kg.

Based on the listed exposed scenarios it was calculated how much BPA a con-

sumer could be exposed to in a realistic worst case scenario. For this scenario

the results of migration to humid fingers were used, which in average was 9

times higher than the measured migration to dry fingers. In the scenario it was

taken into account that the consumer handles the cash register receipts several

times.

The calculated exposure

was compared to a so-called DNEL value. The

DNEL (Derived No Effect Level) has been determined based on animal tests

and illustrates the exposure level, below which no effects are expected. At the

comparison it was taken into account that the consumer is also exposed to

BPA from other sources.

There is some uncertainty to which extent BPA deposed on the skin is actu-

ally absorbed in the body. The EU risk assessment for BPA assumed for its

calculations that only 10% is absorbed, whereas later studies indicate that it

could be a larger quantity and calculations in this study have been made as-

suming that 10% and 50%, respectively, is absorbed.

In order to assess whether there could be a risk related to the exposure, a so-

called Risk Characterization Ratio (RCR) is made by dividing the calculated

internal dose (uptake) with a DNEL value, which designates the level below

which no effects are expected to occur. If the RCR is below 1, the exposure is

assessed to cause no risk. The RCR for the worst case scenario for consumers,

where it is assumed that 50% is absorbed, was calculated to 0.14. If, at the

same time, cumulative exposure from dietary intake is included, the total

RCR will be 0.19. For cashiers a total RCR of 0.79 was calculated. In the cal-

culations it has not been taken into account that BPA on the fingers probably

reduces the amount of BPA left on the skin from the next touch. In a Swiss

study where this effect was taken into account and migration data to more dry

fingers are also included, a considerably lower absorption was calculated than

in the worst case scenarios in this study. As worst case scenarios are used here,

and the RCR values are below 1, it is estimated that with the present knowl-

edge on he effects of BPA there will be no significant risk related to the han-

dling of the cash register receipts.

BPA in baby dummies made of polycarbonate

Polycarbona

te is made by a polymerization of BPA and the final polycarbon-

ate contains small quantities of BPA which is not polymerized. According to

information from suppliers of baby dummies it is estimated that shield and

ring in 10-20% of the dummies on the Danish market are made of polycar-

bonate. The part is diminishing, as other plastic types are used, such as poly-

propylene or co-polyester.

In analyses of BPA exposure from dummies’ shield to artificial sweat and sa-

liva, the migration to both media was below the detection limit for 6 out of 8

examined dummies. For one dummy, migration was above the detection limit

to both media, whereas for one dummy only migration to saliva was found.

In an exposure scenario where it is assumed that the baby has the dummy in

the mouth 7.75 hours a day and assuming that 50% of the amount migrated to

the skin is absorbed, the total RCR value is calculated to 0.0069 which is far

below 1. The results confirm a previous result from a large study of 2 year-

old’s exposure to chemical substances published by the Danish EPA in 2009.

Conclusion

The result

s of this survey thus signify that there is no immediate health risk

related to the use of BPA based cash register receipts and baby dummies. No

matter the results it is worth noticing that BPA has been classified as an endo-

crine system disruptor with the hazard statement ”Suspected of damaging fer-

tility“. The substance is also listed on the Danish EPA’s “List of undesirable

substances”, a signal list and guidance to companies about problematic sub-

stances and use of which should be reduced or terminated in the long term.

Alternatives

to cash register receipts are available, but it has not been investi-

gated to which extent the alternative developers are better from an environ-

mental and health perspective and the costs of changing to the alternatives is

unknown. The alternatives are probably more expensive today because they

are niche products, but this may change with an increased demand for the

alternatives. Parts of the Danish retail trades have informed, that the price for

paper with the alternative developer bisphenol S is approximately twice as ex-

pensive as BPA based paper, while thermal paper without phenol-chemistry is

claimed to be four times the price for paper with BPA. At present the health

risks of papers with alternative developers is unknown. Alternatives to baby

dummies made of polycarbonate today account for a major part of the mar-

ket.

1 Introduction

1.1 Identification of the substance

This study concerns the following substance:

Chemical name: 4,4'-isopropylidenediphenol

Synonym: Bisphenol A; BPA

CAS No: 80-05-7

EINECS No:

BPA structure:

Polycarbonate struc-

ture (polymerised

BPA):

201-245-8

Hazard class and

category codes:

Repr. 2

STOT SE 3

Eye Dam. 1

Skin Sens. 1

Hazard codes and

statements:

H361f: Suspected of damaging fertility

H335: May cause respiratory irritation

H318: Causes serious eye damage

H317: May cause an allergic skin reaction

1.2 BPA in thermal paper

BPA is used

for coating of thermal paper where print is developed by the heat

impact from a print head. The colour is developed by the reaction between a

pigment and a developer which often is BPA, but could also be bisphenol S

(BPS) or other substances. The composition of thermal paper is illustrated

below by two manufacturers. It should be noted that “print” in the first ex-

ample is not the print caused by thermal impact, but can be a pre-print e.g. of

a ticket where the date is printed subsequently with a thermal printer in the

layer indicated as “thermal coat”. Magnetic stripes do not normally appear on

thermal paper used for receipts, but for example on certain types of tickets.

The thermo coating containing BPA is only on one side of the paper. The pa-

per can have a topcoat above the thermal BPA-containing layer.

Illustration from thermal paper manufacturer Mitsubishi HiTec Paper Flensburg GmbH

Illustration fra termopapirproducent Papierfabrik August Koehler AG. Gul firkant 'Color developer'

illustrerer en phenol-fremkalder, der kan være BPA.

Thermal paper can be used for cash register receipts, paper for certain print-

ers, tickets, lottery tickets, stickers and fax paper. Suppliers of thermal paper

point out the following qualities of thermal print: soundless, reliable, low cur-

rent costs, no use of toner or ink, easy to use, no solvents and compact printer

unit. Another quality, often mentioned in connection with e.g. tickets, is that it

is practically impossible to change the print without trace.

Manufacturers of thermal paper are organised in the European Thermal Pa-

per Association (ETPA) which in 2003 organised all manufacturers of ther-

mal paper in EU except one. In 2003, ETPA assessed that 70-80% of all

thermal paper sold in EU contained BPA (DEFRA, 2003). ETPA was con-

tacted in connection with this study, but the association did not know whether

it still applies that 70-80% of the thermal paper on the European market con-

tains BPA (ETPA, 2010).

In the beginning of 2000, approx. 1,400 tons BPA were used for production

on 105,000 tons thermal paper (Møller & Helveg, 2004). On average the pa-

per contains approx 13,000 mg BPA/kg. The latest version of EU’s risk as-

sessment of BPA states that in 2005/2006 1,890 tons BPA were used for pro-

duction of 168,000 tons thermal paper (EC, 2010). This is an increase of 35%

compared to Møller & Helveg’s figures from 2000. Based on these figures the

paper contains approx. 11,000 mg/kg on average.

Until recently the primary focus related to BPA in thermal paper was releases

by recycling of the paper as discussed in the EU Risk Assessment of BPA

(EC, 2010).

1.3 BPA in polycarbonate

BPA

is used as monomer for production of e.g. polycarbonate plastic and ep-

oxy. In the production the substance is polymerised and a stable matrix is cre-

ated. By the polymerisation there will be a small part left of the monomer

which does

not polymerise. The release of bisphenol A is mainly due to re-

lease of free monomers not bound in the matrix.

1.4 Previous studies

A n

umber of previous studies have been undertaken of the release of BPA

from cash register receipts and dummy shields. As the results of these previ-

ous studies will be part of the discussion of the results in this study they will

be briefly reviewed here.

1.4.1 BPA in thermal paper

Swiss study of release of BPA from cash register receipts

Release

of BPA from receipts was recently examined by the food control au-

thorities in the Swiss canton Zürich (Biedermann et al., 2010). 13 different

thermal papers were examined in total and 11 of the samples BPA was found

in concentrations of 8,000-17,000 mg BPA/kg, which is in accordance with

the EU average for thermal paper as indicated above. 10 of the 13 thermal

paper samples were cash register receipts and 9 samples included BPA. BPA

was also found in 2 samples of print paper, whereas there was no BPA in a

trolley ticket. The receipt samples were collected randomly from shops and

tickets for thermal print were identified based on their ability to darken when

heated. In the article it is not indicated how many of the collected receipts are

made of thermal paper. No information about manufacturers/suppliers of re-

ceipts seems to have been collected and it is thus difficult to say how represen-

tative the samples are.

The transfer to fingers was examined by holding the paper for 5 seconds with

a movement where the thumb touched the backside at the same time as the

forefinger and the long finger pressed against the BPA-containing top of the

paper. Transfer to the fingers was measured by extracting BPA from the fin-

gers by dipping them in ethanol and move them slightly for 30 sec. The re-

ceipt was only touched with one hand to imitate the movement when a cashier

takes a receipt out of the printer and gives it to the client. Control tests

showed that by extraction with ethanol, approx. 95% of the BPA released to

the fingers could be extracted.

It can be seen from the results that the transfer differs very much between the

two sides which corresponds with the fact that only one side contains BPA. By

touching the front of the paper, 2.2 µg BPA was transferred to the fingers,

whereas only 0.2 µg BPA was transferred from the backside. The authors

suggest that transfer from the back is due to contamination.

The results show that more than 1.1 µg BPA (interval: 0.2-6 µg) was trans-

ferred on average to each of the two fingers if the skin was dry and more than

10 times more if the skin was wet. The result was more or less the same

whether the receipt was held for 5 sec. or 60 sec. whereas the release was less

if the receipt only was held for 1 sec.

Some of the results, also important for the interpretation of the results of the

present study, are shown in the table below.

Table 1.1

Transfer of BPA to two fingers depending on how the receipt is held and time

(Biedermann

et al.

, 2010)

Method BPA transfer to two fingers

(µg)

Average (µg)

Holding the receipt for 1 sec. 0.4; 0.3 0.35

Holding the receipt for 5 sec.

- standard conditions (in the test) 1.2; 0.9; 1.5; 1.1 1.18

- low pressure 0.7; 0.2 0.45

- pulling the receipt through fingers 0.6; 0.7 0.65

Holds the receipt for 60 sec. 1.5; 0.7 1.10

The quantity that could be extracted did not increase significantly if the re-

ceipts were handled several times in a row which implies that BPA on the skin

prevents additional release from the receipt to the fingers. Based on this, the

authors conclude that persons at a cashier desk would have more or less the

same quantity on their fingers all the time.

Studies of to which extent BPA was absorbed in the skin showed that BPA

applied as a solution in ethanol apparently was absorbed by the skin so that

after 90 minutes only 5 and 40% of the applied dose could be extracted de-

pending on the applied concentration. The authors note that the fact that

BPA cannot be extracted not necessarily means that it has been absorbed in

the body. BPA transferred by handling receipts seems to behave differently, as

after 2 hours 88% could still be extracted from the fingers. The results also

showed that BPA is not very efficiently removed from fingers by washing

them. However, the low number of samples makes this part of the study very

uncertain.

The results are discussed further in chapter 5 in relation to the results of the

present study.

American studies of BPA in cash register receipts

n American study of BPA in receipts for the Environmental Working Group

in 2010 showed that 16 of the 36 collected receipts contained BPA in concen-

trations from 8,000 to 30,000 ppm mg/kg (Lunder et al., 2010). The study

also showed that 0.7-3.8% of the content of BPA could be wiped off the re-

ceipts with a wet paper cloth. The study does not mention to which extent the

paper had a top coat. Another study carried out by Warner Babcock Institute

for Green Chemistry found concentrations of 3,000 to 17,000 mg/kg in 8 out

of 10 receipts made of thermal paper (Mendum et al., 2010).

Swedish study of BPA in thermal paper

In 20

10 a study was made in Sweden of BPA in thermal paper used for vari-

ous purposes. The analysis of cash register receipts were made by different

families collecting receipts over a certain period. Pooled samples were taken of

the receipts and based on the analysis, it can not be concluded that all receipts

contained BPA.

BPA was found in all samples in concentrations varying from 5,000 mg/kg to

32,000 mg/kg with an average of 15,800 mg/kg. It is expected that a similar

content of BPA would be found in Denmark in thermal paper for similar uses.

The study also points out that BPA migrates from the thermal paper to e.g.

notes and lining in wallets. Up to 2,000 mg/kg was found in the lining of a

wallet and

up to 86 mg/kg in 20 kr. notes. It can thus be concluded that there

is also a certain exposure of BPA to these secondary sources even though the

total exposure for secondary sources must be assumed to be low compared to

the exposure to primary sources.

Table 1.2

Test results for BPA in thermal paper (Östberg & Noaksson, 2010).

Description BPA (mg/kg) BPA (%]

Receipts - family 1 14,000 1.4

Receipts - family 2 18,000 1.8

Receipts - family 3 14,000 1.4

Receipts - family 4 9,500 0.95

Receipts – wallet 1 19,000 1.9

Receipts – wallet 2 11,000 1.1

Parking tickets 32,000 3.2

Labels 5,000 0.5

Queue tickets 16,000 1.6

Cash point receipts 19,000 1.9

Print from local authority 16,000 1.6

Air tickets 5,800 0.58

Train ticket 14,000 1.4

Bus ticket 23,000 2.3

Game ticket 18,000 1.8

Medico technical paper slip 18,000 1.8

1.4.2 BPA in polycarbonate

As men

tioned previously, BPA is only released from polycarbonate by migra-

tion of free un-reacted monomers not bound in the matrix.

Norwegian studies of BPA release from baby bottles made of polycarbonate

shows that babies’ intake of BPA via infant formulae is less than the quantities

set by the food authorities as the tolerable daily intake.

BPA in the shield of baby dummies

A previous survey of dummies for

the Danish EPA published in 2009 showed

that the shield of dummies most often consist of hard plastic made of polycar-

bonate or polypropylene (Tønning et al., 2009). More than 30 different

dummies were identified in the survey by shop visits and searching on internet

shops. Out of the 21 products, for which information about the plastic type in

the shield could be achieved, 10 had a shield of polycarbonate whereas the

rest had shields of polypropylene. Because of the large number of products

and retailers it was not possible to determine the market share for each prod-

uct and thus not possible to demonstrate whether dummies with shield of

polycarbonate also represented approx. 50% of the total sale of dummies.

5 dummies were tested in the study, all with shields made of polycarbonate.

The BPA content was by a GC/MS determined at 1,000-1,900 mg/kg

whereas quantitative analysis with GC/MS of two of the shields showed a

concentration of approx. 106 and 280 mg/kg.

Analysis of

BPA migration to artificial sweat and saliva for 7.75 hours from

two dummies showed a migration of 7 mg/kg material to one of the media in

one of the tests, whereas the migration in the other tests were below the detec-

tion value. By using the value of 7 mg/kg it could be calculated that BPA from

dummies potentially could contribute with approx. 15% of the child’s daily

intake of BPA from different sources. When calculating the uptake via the

skin it was assumed, in correspondence with the EU’s Risk Assessment for

BPA, that only 10% of the BPA that is applied to the skin is absorbed in the

body.

2 Mapping

2.1 Cash register receipts

There are a number of Danish companies selling paper for cash register re-

ceipts. Basically there are two types: thermal paper and paper printed differ-

ently. The products are sold as receipt rolls, paper rolls, thermal paper rolls,

thermal paper, thermal rolls and cash register rolls.

The aim of the mapping has been to answer two questions:

1 To which extent are receipts used in Denmark based on thermal pa-

per?

2 To which extent do receipts of various types of thermal paper contain

BPA?

Selection and provision of test material

The working group

has contacted suppliers of receipts. The suppliers have

been identified via searching on the Internet and by contacting a few, large

grocery chains like Danish Supermarket and FDB as they represent a large

part of the total use of receipts.

The two most important suppliers of thermal paper were contacted by phone

and asked to give their best estimate to the above questions based on their

own deliveries and knowledge of the market.

2.1.1 Information from suppliers and manufacturers

One supplier informed that the

company has approx. 50% of the market share

of thermal paper in Denmark. The company assesses that today approx. 80%

of receipt paper on the Danish market is thermal paper and that the share is

increasing. The company also stated that there are different qualities of ther-

mal paper which differs by different types of coating. The company primarily

works with three different qualities, but approx. 99% of the paper to the Dan-

ish market is sold in a standard quality containing BPA in top coating. A

stronger coating can be used if a longer durability of the print is desired, or if

you want the receipt to be more resistant to e.g. grease.

The other large supplier says that between 85-95% of the receipts on the Dan-

ish market are made of thermal paper. The company also estimates that nearly

all thermal paper on the Danish market contains BPA. New products are

however coming up where the more expensive bisphenol S (BPS) is used in-

stead of BPA because the producers try to meet an increasing demand for

BPA-free products. According to the company there are several different

qualities but only few qualities are used in Denmark most is standard quality.

Receipts with a 'top coat' are used in cash point machines, at some petrol sta-

tions, but also in furniture chains that have a long guarantee on many prod-

ucts and shops where you sell long-lasting consumer goods. The company

states that primarily BPS is used in qualities where long durability is required.

The technical reason why BPS is used in these qualities has not been investi-

gated.

Both

of the leading suppliers import thermal paper which they cut and pack

for the retail business or sell to small suppliers. The companies receive the

majority of the coated paper from the following four large manufacturers of

quality paper; primarily from the two first:

1. Papierfabrik August Koehler AG, Oberkirch, Germany

2. Mitsubishi HiTec Paper, Flensborg, Germany

3. Jujo Thermal Ltd. Kauttua, Finland

4. Kanzan Spezialpapiere GmbH, Dueren, Germany

A large internet supplier of receipt rolls estimates that approx 90% of the re-

ceipt rolls on the Danish market are made of thermal paper and that the ma-

jority contain BPA. The company estimates there are maximum 10 different

qualities of thermal paper on the Danish market.

An examination of the product lists for thermal paper on August Koehler’s

and Mitsubishis’ homepages confirm that there are different qualities of ther-

mal paper for receipts ref. Appendix 1 and 2. The qualities are characterised

by their sensitivity (how easy to print) and their durability.

At Koehler they have three different qualities of thermal paper for receipts:

1. Paper with standard sensitivity that can last for minimum 7 years.

2. Paper with high sensitivity that can last for minimum 8 years

3. Paper with medium sensitivity that can last for minimum 5 years

At Mitsubishi they have seven different qualities of thermal paper for receipts:

1. Paper with low sensitivity that can last minimum 10 years

2. Paper with standard sensitivity that can last minimum 5 years

3. Paper with standard sensitivity that can last minimum 7 years

4. Paper with standard sensitivity that can last minimum 25 years

5. Paper with high sensitivity that can last minimum 5 years

6. Paper with high sensitivity that can last minimum 10 years

7. Paper with high sensitivity that can last minimum 12 years

A leading supplier explains that a quality with high sensitivity can be used at a

fast printer with a very precise result. The less heat required developing col-

our on the paper, the more sensitive it is. The contacted companies explain

that BPA is important for the sensitivity of the thermal paper, but they are not

aware whether the paper with high sensitivity contains more BPA.

thermal paper quality with high durability has a coating protecting against

grease and UV radiance. Thermal paper can be identified from non-thermal

paper by scratching a nail tip over the paper. If it is thermal paper the nail will

leave a colour line as the heat from the scratch is sufficient to develop the col-

our.

One of the leading suppliers estimates that the use of thermal paper for re-

ceipts in Denmark is 1,000 to 1,200 tons per year. 2/3 is used in daily food

chains and the rest in other sectors such as selected goods stores (e.g. furni-

ture stores), restaurants, petrol stations, libraries, hospitals, etc. When testing

the receipts it turned out that approx. 60% of the receipts contain BPA (Table

4.1), but the actual percentage is probably larger as it by the collection has

aimed at covering many different types of receipts. The questioned suppliers

estimate that the majority of receipts made of thermal paper contain BPA. In

this study it will be assumed that the Danish market equals the EU average

where 70-80% of the thermal paper contains BPA. Based on the estimates and

figures of the average content of BPA in thermal paper 11,000 – 13,000

mg/kg (ref. section 1.2,), it is estimated that the total content of BPA in re-

ceipts used in Denmark is between 9 and 12 tons BPA a year.

Alternative developers

Analysis of

the receipts (section 4.2.1) revealed that some types of thermal

paper types do not contain BPA or BPS. Both Jujo Thermal and Kanzan Spe-

zialpapiere deliver thermal paper without the two substances, but it has not

been possible to get information about which developers are used.

Jujo Thermal describes the paper types on their website where they inform

that phenol-chemicals are not used in the paper, i.e. the paper neither contains

BPA nor BPS (Jujo, 2010). An example of the types without phenols,

AP62KJ-R, is listed to have 25 years ”image stability” and may be used for

receipts, labels, bank receipts, parking tickets and medical purposes.

2.2 Baby dummies

As mentione

d in the previous mapping, baby dummies are sold in many types

of shops: baby care shops, pharmacies, groceries, daily food stores, internet

shops, etc. A mapping of the market for dummies was made in relation to an-

other test in 2008/2009 (ref. section 1.4) and it has thus not been the intention

to repeat this mapping.

In order to have an indication of whether there have been major changes in

the last years in relation to plastic in the shields, a search was made on the

supply of dummies in Danish internet shops. A few key manufactur-

ers/importers of dummies with consumer facts (Danish: varefakta) registered

with the Danish Institute for Informative Labelling (Dansk Varefakta Nævn)

were contacted. Altogether they are representing more than 30 different labels

including ”Apotekets” (from the pharmacies) and Matas.

Phase 2 of the internet search included purchase of dummies with a shield of

polycarbonate representing a representative sample of manufacturers of

dummies sold by different shops, including internet shops.

2.1.1 Information from manufacturers and retailers

Only two of the three manufacturers of labelled dummies have contributed to

the study as the third and smallest supplier have stopped the production and

the product will no longer be marketed.

The largest Danish manufacturer estimates that 10-20% of the shields on

dummies on the Danish market are made of polycarbonate today and that the

share is decreasing. The company assess that this is due to a large pressure

and wish from both politicians and consumers to find alternatives to polycar-

bonate. When contacted, less than 5% of the company’s own products were

made of polycarbonate and this share is also decreasing. The company is out-

phasing polycarbonate entirely and plans not to use it at all by the end of

2010. Tritan

copolyester is used an alternative to polycarbonate, but it is

not as suitable as it is more fragile, less heat-resistant and not apt for print.

A Danish distributor of dummies from a leading international manufacturer

says that this manufacturer also have used the alternative Tritan

copolyester

since February 2010.

2.2.1 Dummies sold via the Internet

study of dummies sold on the Internet in view of identifying dummies with

shield of polycarbonate for this study showed that in this market segment still

is a major part of the dummies have a shield of polycarbonate (ref. appendix

3).

Out of 15 types of dummies where the plastic type of the shield was specifi-

cally indicated, 10 were made of polycarbonate. These 10 dummies were pro-

duced by 7 different manufacturers in Denmark, Sweden, USA, Germany

and Austria. It should, however, be noted that a major part of these are sup-

plied as dummies with the possibility of having the child’s name printed on

them (MyDummy) and that polycarbonate apparently is very suitable when

names should be printed on the dummy.

2.3 Summary

The study

shows that the largest Danish suppliers of cash register receipts as-

sess that approx. 90% of cash receipts used in Denmark is based on thermal

paper. The usage is increasing and several large stores are about to change

from non-thermal paper to thermal paper. Furthermore the study indicates

that BPA is used in thermal coating on the major part of receipts. For papers

with long durability some manufacturers are now using BPS. In some types of

receipts other developers are used, but it has not been possible to find out

which substances are used.

In Denmark, use of thermal paper for receipts is estimated to be between

1,000 and 1,200 tons a year. According to the contacted companies, the Dan-

ish market is dominated by two large suppliers having a market share of more

than 90%.

There are approx. 10 different qualities of receipts on the Danish market, dif-

ferentiating by different sensibility and durability. The content of BPA is im-

portant for a visible print on the receipt.

According to a leading supplier of dummies, dummies of

polycarbonate rep-

resent 10-20% of the market. The market is actually moving away from

dummies made of polycarbonate replaced by dummies of copolyester. An

internet search shows that there are still many types of dummies on the mar-

ket made of polycarbonate. As dummies made of polycarbonate are particu-

larly good for print it is assumed that the sale via the internet not necessarily is

representative for the entire market as there are relatively many dummies sold

via the internet.

3 Exposure scenarios

3.1 Calculation of consumer exposure

Exposure scenarios are developed in line with the REACH guidance ‘Guid-

ance on Information Requirements and Chemical Safety Assessment. Chapter R.15

- Consumer exposure estimation’, version 2 from April 2010 (ECHA, 2010a).

Algorithms and formulae for dermal exposure are based on the models shown

in section R.15.3.2.2 on dermal exposure and scenarios involving non-volatile

substances migrating from an article and R.15.3.3 on oral exposure. The for-

mulae are here modified to include results of analysis of BPA migrating to sa-

liva and sweat simulants. The potential uptake per time unit (internal dose) of

BPA from exposure to cash register receipts and dummies is compared to the

DNEL (Derived No Effect Level) for BPA.

3.2 Cash register receipts

The exp

osure calculations involve calculating the amount of substance which

will migrate from the surface of a product in contact with skin. As outlined in

the guidance document, the essential parameters used for this model are:

 Weight fraction compound: the fraction of the compound in the total

product

 Amount of product: the total amount of product applied to the skin

 The surface area of the exposed skin

 The migration rate of the substance absorption

 The contact time of the substance absorption

 Skin contact factor, a factor that can be used to account for the fact that

the product is only partially in contact with the skin.

The dermal load is then calculated using the following equation (Equation

3.1):

where is the weight of the receipt. is the share of BPA in the re-

ceipt and

is the rate BPA migrates from the receipt to sweat. is

the area in contact with the skin in those cases where the skin in only partly in

contact with the receipt. The default value for

is 1. is the time

the skin contacts the receipt.

The used parameters are explained in Table 3.1.

Tier 1 exposure scenario

For a Tier 1 assessment (first rough assessment of potential risks) of the ex-

posure from

cash register receipts, the migration of BPA from collected re-

ceipts to a sweat simulant was measured and used for the calculation of the

dermal load.

By using the migration of BPA (Migr.) to a sweat simulant per surface and

time unit the dermal load is calculated based on the following equation:

where the measured migration to sweat per surface and time unit is consid-

ered equivalent to the amount of BPA migrating to the skin:

The Tier 1 model probably result in a considerable overestimation of the ex-

posure as the amount of BPA which can be extracted from the submerged

receipt is expected to exceed the amount of BPA which can migrate to the

fingers when handling the receipt, even when the fingers are humid.

The external

dermal dose (dermal exposure of the skin) in mg per kg body-

weight is then calculated based on migration data to the sweat simulant:

which is equivalent to:

If you include absorption through skin in the formula, the internal dermal

dose (what is absorbed and may be taken in the blood veins) of BPA mg per

kilo bodyweight is calculated as:

Parameters and symbols used in the formula that here are used for the dermal

exposure scenarios are explained in Table 3.1.

Table 3.1

Explanation of symbols used in exposure scenario for skin (based on ECHA, 2010

Input parameter Description Unit

prod

Amount of product used mg

prod

Weight fraction of substance in prod-

uct

mg/mg product

migr

Rate (fraction) of substance migrating

to skin per time unit

mg/mg/t

Migr. Amount of substance migrating to

skin per skin area and time unit

mg/cm

Extr. Amount extracted from exposed fin-

gers per area and time unit

mg/cm

contact

Fraction of product in contact with

skin (default = 1)

/cm



contact

Contact duration between article and

skin

Contact area between product and

skin

der

Dermal concentration of substance on

skin

mg/cm

BW Body weight kg

n No of incidents per day d-1

abs

* Dermal absorption %

Output parameter Description Unit

der

Dermal load on skin due to migration mg/cm

der

Dermal dose per day and body weight mg/kg bw/d



* For a Tier 1 estimation, a dermal absorption of 100% is normally used.

Realistic worst case scenario

A more realistic worst case scenario is based on measurements of BPA ex-

tracted from a known skin area exposed to receipt for a typical handling time.

In this case the equation for the dermal load is as follows:

The external

dermal dose in mg per kg bodyweight is then calculated based

on data from analysis of the amount of BPA extracted from the fingers using

the following equation:

If you include the absorption through the skin in the formula, the internal

dermal dose in mg per kg bodyweight is calculated as:

As illustrated exposure will depend on the migration of BPA in the receipt,

how long time receipt is in contact with the skin (contact duration), how many

times during the day the person is in contact with thermal paper/receipts (fre-

quency) and the area of the fingers in contact with the receipts.

3.2.1 Determination of exposure parameters for consume

r exposure

In the exposure scenario for cash register receipts the parameters “duration of

contact”, “frequency of incidents per day” and “surface of exposed skin”

were determined as follows:

Duration of contact

Duration

of contact has been set based on observations of consumer behav-

iour in a large supermarket. 25 random customers were observed and on av-

erage they held their receipt for 11 seconds in the shop. Nine of the 25 cus-

tomers didn’t want to take the receipt. The 16 customers who took the receipt

on average held their receipts for 17 seconds. For some of the time they held it

with two hands; for some of the time they held it in only one hand. Two cus-

tomers held it for 55 and 66 seconds, respectively, most of the time with one

hand. The customers that chose to take the receipt all kept it. They didn’t

throw it out but put it in their pocket, bag or purse. These customers will

most likely be in contact with the receipt one or two times more when it is

disposed of and/or archived. We assume that the customers are in contact

with the receipt for a shorter period the second time they handle the receipt

(e.g. to throw it out).

Based on these observations a standard handling was determined representing

both the handling in the shop and the subsequent handling when the receipt is

thrown out or archived (and later thrown out). In this scenario the receipt is

held with both hands for about 10 sec. where the fingers move over the re-

ceipt while it is checked and then folded. When folding the receipt, the BPA-

containing side is turned out so all fingers are in contact with this side during

folding.

Frequency

The frequency of contact with receipts containing

BPA has been estimated by

extrapolating data on payment card transactions and the payment methods in

a large Danish supermarket chain as described below.

A large Danish supermarket chain has provided information on number of

transactions where credit cards are used as payment method. Information

about total number of payment card transactions in Denmark is based on in-

formation from Nets (previously PBS), data on the Danish population are

from Statistics Denmark and the two largest suppliers of receipts have pro-

vided an estimate of the percentage of receipts based on thermal paper. The

percentage of receipts of thermal paper containing BPA is based on general

EU data as it is assumed that these data also apply for the Danish market.

Obviously there can be variations in the pattern of payment methods in differ-

ent sectors. Customers who shop in stores selling expensive consumer goods

more often use credit cards as payment whereas customers in small newspa-

per stands rather pay cash. Using data from a large supermarket chain is con-

sidered to give a good average picture of the payment patterns in Danish

stores in the absence of more precise data. Parameters and results from the

calculation of how many receipts the consumers handle annually can be seen

in Table 3.2.

Based on the above, the total number of receipts with BPA used in Denmark

is estimated at 1,220 million a year. Alternatively the number can be estimated

based on the total tonnage of thermal paper rolls delivered, estimated by a

leading supplier at 1,000-1,200 tonnes per year. In a recent Swedish study of

BPA in

thermal paper, the average weight of 47 randomly sampled cash regis-

ter receipts is reported to be 0.55 gramme (Östberg, T. & E. Noakson ,

2010). Using this average weight and assuming that 75% of 1,000-1,200 tons

thermal paper contains BPA, the total number of BPA-containing receipts can

be estimated at 1,355 – 1,627 million. This alternative estimate indicates that

1,220 million receipts in Table 3.2. are probably not far from the actual num-

ber and the uncertainty of this estimate is probably lower than the uncertainty

on other parameters used for estimating the total number of handled receipts.

In addition to when the receipts are received, the receipt will be handled again

at least once when it is disposed of. It is possible to imagine many different

scenarios for the disposal and/or archiving. Some people save all their receipts

in a binder, others keep them in their wallet until it is full and then throw most

of them out and keep a few. Before the receipts are disposed of, the customer

often checks it again and all received receipts will be handled twice. Here it is

roughly assumed that those consumers who carefully check the receipts and

keep them, on average handles each receipt 2.5 times.

Some consumer groups receive more receipts than the average consumer.

Women with children at an age where they do not shop themselves receive

considerably more receipts than the average. It is here roughly estimated that

these consumers receive twice as many receipts as the average consumer, and

they thus handle about 3.6 receipts a day (ref. Table 3.2).

Besides cash register receipts the consumer will also be exposed to BPA in

thermal paper used for other applications: library receipts, queue tickets, la-

bels, parking tickets, boarding pass etc. It has not been possible to obtain data

on use of thermal paper for all these applications. It has been roughly assumed

that the consumer group “women with children” on average handle one of

these receipts/ tickets a day.

Table 3.2

Parameters used for calculating the frequency i.e. number of events receipts handled

per day

Credit card transactions:

Danish credit card transactions in 2009 * 828 million

Internet transactions * 45 million

- here of Dankort/Visa Dankort * 38 million

Dankort as % of total 83%

Number of Dankort transactions less internet transactions 790 million

Number of transactions assuming that Dankort transactions

represent 83% of total

952 million

Data for supermarket chain:

- card transactions per year 125 million

- transactions per year 237 million

- card transactions in percent of all transactions 53%

Estimated number of transactions (receipts)

in Denmark

1,807 million

Receipts:

Share of receipts made of thermal paper **** 90%

Share of receipts made of thermal paper containing BPA 75%

Estimated number of receipts with BPA-containing thermal

paper

1,220 million

Receipts per inhabitants:

Population in Denmark above the age of 12 in 2009 4.7 million

BPA-containing receipts per consumer above 12 years, per year 259

BPA-containing receipts per consumer above 12 years per day 0.7

Number of times each receipt is handled 2.5

BPA-containing receipts handled per consumer above 12 years

per day

1.8

Factor for consumers handling more than the average 2

BPA-containing receipts handled per consumer per day in the

group handling relatively many receipts.

3.6

BPA-containing receipts handled per consumer per day in the

group of consumers handling relatively many receipts – includ-

ing thermal paper used for other purposes

4.6

* Total number of card transactions in Denmark in 2009 was 3,038 million, but according

to Nets (personal contact) the main part of these transactions are not payments in

shops in Denmark. There are only data for transactions with Dankort.

Source: NETS, 2010.

*** Source: Statistics Denmark.

**** Source: Leading suppliers of receipts.

Contact area between product and skin

The contact area between the cash register receipt and skin highly depends

how the receipt is handled. When checking the receipts the customer will usu-

ally touch the receipts several times at different parts of the surface.

Consequently the touched part of the receipts will be larger than the part of

the skin touching the receipts. The touched surface has been estimated by let-

ting two persons handle four receipts after their fingers had been blackened

with ink. The test was illustrating two different scenarios. In scenario 1, the

cus

tomer receives the receipt, looks at it briefly and throws it away. In sce-

nario 2 the customer examines the receipt more closely before folding it and

putting it in the purse. Scenario 2 is the scenario used later in connection with

studies of how large quantities of BPA migrating from the receipt to the fin-

gers.

As the receipts have BPA on the upper side only, it is of great importance for

the exposure whether the receipt is folded with the upper side or the lower

side against the finger pads. In scenario 2 the receipt is folded with the upper

side turning outside in touch with the finger tips.

In scenario 1 where it primarily was the thumb, which was in contact with the

receipt but touched it several places, the blackened part of the upper side was

on average 8.3 cm

. The total surface of thumbs having been in contact with

the receipt was smaller. In scenario 2 where the receipt was folded, was on

average 46 cm

of the blackened upper side. The major part of this area, how-

ever, was touched for much less than 5 seconds.

The results of the Swiss study indicate that even though the receipt is handled

several times it does not result in a significantly higher amount of BPA on the

skin. It is therefore assumed that migration of BPA to the skin is proportional

with the skin area being in touch with the receipt. The area of the finger pads

being in touch with the receipt is different from person to person, but typi-

cally approx. 10 cm

of the finger pads (on 8 fingers) will be in contact with

receipt when it is checked and folded with the front side turning out.

The parameters used in the two scenarios are shown in Table 3.3.

Scenario for

cashier workers

Focus of this study is exposure of the consumers, but as the cashiers are also

exposed to BPA in receipts, a variation of the scenario has been made with

values that are assessed to be representative for a cashier’s handling of the re-

ceipts. No studies have been made in order to determine the parameters. A

cashier in a supermarket roughly handles approx. 100 receipts a day (equiva-

lent to one transaction each 4.5 min.) and the receipt is handled with one

hand for 5 seconds.

Table 3.3

Parameters for the exposure scenarios for exposure of consumers and cashiers to BPA

in cash register receipts

Parameters for exposure scenarios Value Source

Total migration from re-

ceipt to sweat simulant in

mg/cm

for 5 seconds

Migr

Total

0.14*10

-3

Measured value

Migr , mg/cm

/sec.

Migr. 2.8*10

-3

Calculated based on measured

value

Duration of contact, sec.

per incident

contact

Consumers: 10

Cashiers: 5

Consumers - based on observa-

tions

Cashiers – Rough estimate

Fraction product in contact

with skin, cm

/cm

contact

1 Default value

Frequency, number of inci-

dent per day

Consumers: 4.6

Cashiers: 100

Consumers: worst case based

on calculations of total number

of receipts per year in Denmark.

Cashiers: rough estimate

Surface of finger pads

being in contact with the

receipts, cm2 A

skin

Consumer: 10

Cashier: 5

Consumers: Worst case based

on observations. Cashiers:

Rough estimate based on as-

sumption that cahiers only han-

dle the receipt with one hand.

Dermal absorption, %

abs

10 / 50

Dermal absorption of 10% as in

the EU risk assessment (EU,

2010) and 50% as indicated in a

later study (ref. section 5.1.2,

Zalko

et al

, 2011)

Body weight of consumer

and cashier, kg

BW 60

Average body weight of a grown

woman

3.3 Baby dummies

In the

previous study of 2 year-olds’ exposure to BPA from dummies with

shield of polycarbonate it has been assumed that the child is exposed via sweat

and saliva for 7.75 hours a day (Tønning et al, 2009). This value was deter-

mined as a worst case based on British and German studies of babies’ dummy

behaviour. The reason was that children, when they use the dummy, partly

will be in contact with the shield when they have the dummy in their mouth,

partly will be in contact with shield and ring when they handle the dummy.

Often the children touch the dummy when they have it in the mouth. When

they have the dummy in the mouth a part of the shield will be in contact with

saliva from the mouth and a part of this saliva will be swallowed. There will

also be part of the shield that is in contact with the skin around the mouth.

The child can use the dummy when it sleeps, during the night and during the

day and it can use the dummy for comfort. We assume that, as in the previous

study, the baby has oral contact with approx 25% of the surface of the shield

(approx. 50% of the part facing the mouth) and has dermal contact with

approx. 25% of shield and ring (if the dummy has a ring) but so that the ma-

jor contact is between face and shield.

3.3.1 Dermal exposure

In this sce

nario the exposure calculation involves an estimation of the same

essential parameters used for the calculation of the dermal exposure from

BPA in cash register receipts.

For dummies only the

worst case scenario has been made based on migration

of BPA from the dummy shield to a simulant sweat.

The exposure will depend on the amount of BPA in the dummy shields and

handle, the migrating to sweat, the contact duration, the area of the shield in

contact with the skin and the absorption of the substance.

According to the guidance document, the dermal load is calculated as follows:

with

being the weight of the dummy, the fraction of BPA in the

shield and

the rate of BPA migrating from the pacifier to sweat.

is the contact area between the skin and the shield (surface of the shield) and

is the share of this area in contact with the skin. is the period

the skin is in contact with the dummy.

When results of analysis of the migration (Migr.) of BPA per surface unit

from the shield to simulant sweat are available for a period equivalent to the

contact period, the formula for dermal exposure is as follows:

where the measured Migr. is equivalent to:

The external dermal dose can then be calculated as:

And the absorbed (internal) dermal dose in mg per kg body weight can then

be calculated based on the following formula:

Where

is the surface of the skin in contact with the dummy’s shield,

is the part of the shield in contact with the skin, n is number of con-

tacts with the shield per day,

is the absorption through the skin and BW

is the body weight for the baby using the dummy.

For the exposure assessment two calculations are made where it is assumed

that the dermal absorption is 10% in line with the EU risk assessment and 50%

based on new studies as mentioned in the section on cash register receipts.

Parameters used in the dermal exposure scenario are shown in Table 3.3 3.4.

Table 3.4

Parameters for dermal exposure scenario for BPA in baby dummies

Parameter Value Source

Total amount migrating to

sweat per kg or cm

over 7.75

hours

Migr

Total

4.17 g/27.8 cm

shield (0.15)

Based on analysis of migration

from a 27.8 cm

shield for 7.75

hours

Migration to sweat, g/cm



hour

Migr. 0.019

Based on total migration divided

by with 7.75 hours

Contact duration, hours T

contact

7.75 (Tønning

et al,

, 2009)

Fraction of contact area for

skin, cm

/cm

contact

Default – 1 cm

skin touches 1

of the shield

Surface of exposed skin, cm

skin

6.95

The exposed skin surface is set to

equal 25% of the shield. (Tønning

et al,

, 2009)

Dermal absorption, %

abs

10 / 50

Dermal absorption of 10% as in

the EU risk assessment (EU,

2010) and 50% as indicated by a

later study (Zalko

et al.

, 2011)

Body weight, kg

BW 4.5

Body weight of a 1-2 month old

baby

Incidents per day

n 1

One contact incident lasting 7.75

hours is estimated as worst case

(Tønning

et al,

, 2009)

3.3.2 Oral exposure

Oral expos

ure is the result of swallowing saliva containing BPA migrated from

the dummy to the saliva. Oral exposure expressed as the internal dose will de-

pend on the amount of BPA migrating to the saliva and the amount of saliva

swallowed during use of the dummy.

The amount of BPA migrating to the saliva will be determined in an analysis

where the shield of a pacifier is submerged in a saliva simulant and the

amount of BPA migrated to the saliva simulant is measured over a time period

of 7.75 hours. It was decided to let the migration tests (for both sweat and sa-

liva simulant) follow the same period of time as used for contact period in the

exposure scenario to avoid any uncertainty about changes in the migration

rate over time.

It is assumed that BPA can migrate to an exposed area around the mouth cor-

responding to 25% of the surface of the shield.

It is assumed that the absorption is 100% and that the total amount of BPA

migrating to the saliva from 25% of the surface of the shield will be ingested

by the child.

When the migration of BPA from the shield to the saliva (Migr.) per surface

unit is analysed for a given time period, the formula for the daily internal dose

is calculated as follows:

For the worst case scenario, the body weight of a 1-2 month old baby of 4.5

kg is chosen.

Table 3.5

Parameters for oral exposure scenario of BPA in baby dummies

Parameter Value Source

Surface of shield, cm

shield

27.8 Analysis

Fraction of surface in con-

tact with saliva, cm

/cm

contact

0.25

25% of shield surface

(Tønning

al.

. 2009)

Contact duration, hours T

contact

7.75 (Tønning

et al.

. 2009)

Total amount migrating to

saliva per cm

over 7.75

hours, g/cm

/7.75 time

Migr

Total

0.049

Calculated based on analysis of

migration from 27.8 cm

shield

for 7.75 hours

Migration rate to saliva,

g/cm

/ hour

Migr. 0.0063

Calculated based on total migra-

tion (divided by 7.75 hours)

Oral absorption, %

abs

100

It is assumed that the child swal-

lows all the saliva containing BPA

Body weight, kg

BW 4.5

Body weight of a 1-2 month old

baby has been selected for the

scenario

Incidents per day

n 1

One contact incident lasting 7.75

hours is estimated as worst case

(Tønning

et al.

. 2009)

4 Analyses

4.1 Collection, methods of analyses and test design

4.1.1 Cash register receipts

Collection of cash register receipts

Bas

ed on information from the suppliers on where it can be expected to find

receipts of different qualities of thermal paper, 12 printed receipts was col-

lected from the following shops or places:

 Shops representing groceries: grocery chains, discount supermarkets and a

toy shop.

 Shops that are expected to use receipts with long durability: a furniture

chain and a hardware store.

 Machines that are expected to use weather resistant paper qualities (e.g.

with top coat): two cash machines at petrol stations and a cash withdrawal

machine in a bank.

 A library.

Furthermore, there has been collected one sample of a sticker from the weigh-

ing of vegetables in a supermarket.

At the collection is has been envisaged that the receipts were printed with at

least 6-10 transaction lines. A total of 7 receipts have been collected from each

of the collection points.

Disposable gloves were used at the sample collection to avoid cross contami-

nation of the tests.

Analyses of content

subsample of each type of receipt was weighed and the surface measured.

The subsamples were selected so they represent an average receipt with 6-10

printed lines.

BPA was extracted from the sample by immersing the sample in methanol at

60C for one night. The extracts were subsequently diluted with methanol,

deuterium labeled internal standard BPA-dx was added and analysed by use

of reverse phase HPLC.

For each analysis series, two control samples of low and high concentration

level were included to verify the calibration.

In order to verify the presence of BPA, the tests were analysed with GC/MS.

In this analysis it was also qualitatively determined whether the sample con-

tained BPS, but the BPS concentration was not quantified.

For all samples a double determination was made (applies for all analysis), i.e.

for each test two analyses of extraction fluid/contact fluid were carried out.

Analysis of migration to sweat

Based on the results of the analyses of the content all 7 samples containing

BPA were selected for migration analysis.

A subsample of each of the 7 types of receipts was weighed and the surface

are was measured. As with the analysis of the content the subsamples were

taken so they represented an average receipt with 6-10 printed lines. The

sample was immersed in 20 ml sweat simulant, pre-heated to 37 C for 5 sec-

onds. It was ensured that the entire surface was exposed to the contact media.

The sample was not shaken during the immersion.

For the migration tests an extraction time of 5 sec. were used which is some-

how shorter than what the average time a receipt is handled. The short time

was chosen to avoid that the receipt began to dissolve and the migration thus

would be unrealistically high.

The used sweat simulant is described in DS/EN ISO 105-E04 and consist of

1-histidine monohydrochloride-1-hydrate, sodium chloride, sodium dihydro-

gen phosphate and sodium hydroxide for adjustment of pH to pH 5.5. The

simulant has previously been used for migration analysis in other of DEPA’s

consumer projects.

A part sample of the contact media was diluted with methanol added deute-

rium labelled internal standard of BPA-dx and the sample was analysed by

reverse phase HPLC.

Analyses of migration to fingers

It is a

ssumed that the exposure of the consumer primarily will be through fin-

ger pads via sweat and tests were made of how much BPA was migrated to

the fingers when handling BPA-containing receipts.

The test method follows the method used in the Swiss study (Biedermann et

al., 2010), however the handling of the receipts in the present study corre-

sponded to a consumer’s handling of the receipts. In the Swiss study focus

was on the cashier’s handling of the receipt.

Before the first test and between all the tests the hands were washed with hot

water and soap and air-dried. The fingers were then moved for a while to ob-

tain a natural humidity on the surface.

The receipt was held with both hands and handled with hands’ thumb, fore-

finger, long finger and ring finger. The fingers moved down over the receipt

for 5 sec. and then the receipt was folded with the front (with BPA) outwards.

The folding took 5 more seconds. During the folding where the fingers all the

time were in contact with the BPA-containing front there was a light pressure

for each folding.

The forefinger, long finger and ring finger were then dipped for 30 seconds in

ethanol in a Petri dish to extract the BPA from the fingers. The fingers were

moved slowly during the extraction and rinsed afterwards with ethanol col-

lected in the dish. This was repeated with the two thumbs. In the Swiss study

various extraction methods were used and the result was that a satisfactory

extraction could be achieved by lowering in ethanol for 30 sec. (95% recovery

in recovery tests).

One time

during the test an extraction was carried out of possible leftovers of

BPA on the fingers after being washed by dipping the fingers for 30 sec. in

ethanol with subsequent rinse in the same way as after handling the receipts.

When testing with humid fingers the fingers were moistened with sweat simu-

lant. There were no visible drops on the fingers, but they were shiny. The re-

ceipts became visibly humid (dark) where they were handled the first time,

but after the first handlings there were no longer a visible effect of the han-

dling. The fingers were in the test more humid than normally when sweating

on a hot summer day or after a run. As the humidity changed very fast be-

cause the liquid was absorbed by the skin there has been made no attempt to

quantify the degree of humidity.

When testing fingers with hand lotion, a lotion labelled ”Derma Helse,

Decuderm u/parfume, hudneutral, specialpleje” was used. A limited amount

of lotion was put on, drying in so the fingers were shiny without being very

greasy. There were no visible marks on the receipts after touching.

Recovery and analyses of intake to the skin

To te

st the recovery of BPA, two fingers were dipped in a known amount of

BPA diluted in water and the fingers were subsequently dipped in ethanol for

30 sec. for the extraction of BPA. The aim of the test was to show to which

extent the amounts that were extracted from the fingers after handling of the

receipts correspond to the amounts that actually migrated. Two tests were

carried out where 1.9 and 9.5 µg BPA, respectively, were applied to two fin-

gers. As BPA is difficult to dissolve in water a dilution was made in ethanol,

which subsequently was diluted with water so that the diluted solution con-

tained 0.3% ethanol. As it was not possible to make a sufficiently high solution

of BPA so that the 9.5 µg BPA could be put on once it was necessary to put it

on 5 times with the evaporation of water in between the applications.

Before the extraction it was ensured that the water had evaporated which was

approx. 1 min. after the application of the 9.5 µg BPA. With this method

there is a risk that there has already been an uptake of BPA in the skin. At the

tests with handling of the receipts an extraction was made immediately after

the handling (which took 10 sec.) and there is thus a possibility that the ex-

traction in the tests with the receipts are better than at the recovery tests.

A similar test was made where extraction of the applied BPA was made after

two hours.

4.1.2 Dummy shield

Purchase

8 types of

dummies made of polycarbonate were purchased representing 8

different manufacturers. Six of the dummies were bought via the Internet

whereas the two others were bought in daily groceries shops.

Analyses of content

There has been made

no analyses of the content of the dummies. BPA are

free monomers in polycarbonate and it should be expected that the concentra-

tion is at same level as found in previous studies. In the study of 2-year-old’s

exposure to chemical substances (Tønning et al., 2009) concentrations of 106

and 280 mg BPA/kg, respectively, were found in two dummy shields.

Scalding

Before the analysis all dummies were scalded for 5 min in boiling water and

the dummies were left for 7 days before the analyses. By leaving the dummies

for a week any potential diffusion of the BPA to the surface of the dummies

after the scalding would be taken into account.

Analyses of migration to saliva and sweat

Before the

analyses the shield was removed from the dummies, the shield was

weighed and the surface area measured. The intact

shields were lowered in

the contact media of a saliva simulant and a sweat simulant for 7h45 min at

37C. The contact media were heated to 37C before the products were im-

mersed.

A single extraction for each dummy shield was made with the selected contact

media.

A subsample of the contact media was diluted with methanol with deuterium

labelled internal standard of BPA-dx and analysed by reverse phase HPLC.

For each analysis two control tests were included at low and high concentra-

tion level for the verification of the calibration. The contact media was added

a known concentration of BPA and BPA-dx in order to demonstrate the re-

covery of BPA.

The used artificial sweat simulant is described in DS/EN ISO 105-E04 and

consists of 1-histidinmonohydrochloride-1-hydrate sodium chloride, sodium

dihydrogen phosphate and sodium hydroxide for the adjustment of pH to pH

5.5.

For migration analyses with saliva a simulant of artificial saliva was used. The

used saliva simulant is described in a JRC rapport (JRC, 2001). The artificial

saliva consists of calcium chloride, magnesium chloride, potassium carbonate,

potassium chloride, potassium phosphate, sodium chloride and hydrochloric

acid for adjustment of pH to pH 6.8. The stimulant has been used before in

DEPA’s consumer projects.

4.2 Results of analysis

4.2.

1 Cash register receipts

Analysis of content of BPA in cash register receipts

The results

of the analysis of BPA in receipts and migration to artificial sweat

are shown in Table 4.1. The area is indicated as the area of the receipt, i.e. the

area is the

BPA-containing front.

The analyses of the content show that 9 of the 12 receipts contained BPA, but

two of these contained BPA in such small quantities that it probably derives

from a cross contamination.

The content of BPA in the 7 receipts with high BPA content varies from

8,700 to 17,000 mg BPA/kg. The two receipts containing most BPA are from

to discount supermarkets and contained 17,000 and 14,000 mg BPA/kg re-

spectively. Lower values were found in five receipts from a discount super-

market, two grocery chains, a library and a toy shop. These receipts contained

between 8,700 and 11,000 mg BPA/kg. The average value for the 7 receipts

were 11,400 which is slightly lower than the average values found in the

Swedish, S

wiss and American studies referred to in section 1.4. In these stud-

ies the

following average values were found: 15,000 mg/kg (Sweden), 12,500

mg/kg (USA) and 13,500 mg/kg (Swiss).

There is no direct connection between the content of BPA in mg/kg and in

µg/cm

. The receipt from the grocery chain 1 has a higher content of BPA per

kilo paper than the receipt from daily goods chain 2 whereas the opposite ap-

plies when looking at BPA per cm

. It is thus two different paper qualities.

In three of the 12 receipts the concentration of BPA was below the detection

limit of 0.1 mg/kg. A subsequent GC/MS analyses showed the presence of

BPS (bisphenol S) in these receipts, but there have been made no quantitative

analyses of BPS. These receipts are from a bank (cash withdrawal machine),

petrol station (payment machine) and a furniture store. This confirms infor-

mation from receipt suppliers that thermal paper for these purposes is often

coated and contains BPS instead of BPA.

Two of the BPA-containing receipt had a far lower content of BPA of 37 and

0.28 mg BPA/kg, respectively. These receipts are from a hardware store and

petrol station. The low content of BPA in the two receipts, and the fact that

the GC/MS analyses did not reveal presence of BPS, may be why another de-

veloper is used in these receipts. BPS has only been made analysed qualita-

tively. The quantities of BPA equals the amounts which the Swedish survey

showed could be migrated from BPA-containing receipts to notes. By sam-

pling and analyses new clean gloves have been used for each test and cross

contamination should consequently not be possible. The receipts give a colour

reaction with the test method used to verify whether it is thermal paper or not.

The receipts could be cross contaminated from the manufacturers who also

manufacture BPA-containing paper. The suppliers have confirmed that the

thermal paper originates from the Finnish manufacturer Jujo and the Ger-

man-Japanese manufacturer Kanzan. Jujo states at their website that in certain

types of the company’s thermal paper phenol based developers are not used.

As expected based on information from suppliers, the receipts with long du-

rability from payment and cash withdrawal machines or from a furniture

chain and hardware store did not contain BPA. The fact that 5 out of 12 sam-

ples did not contain BPA cannot be used to conclude that there will only be

BPA in 60% of receipts made of thermal paper on the Danish market. By se-

lecting the receipts it has been deliberately tried to get a large coverage and

cover most of the applications where special thermal paper is used. The major

part of the tonnage is for receipts for groceries and these receipts all contained

BPA. As there is no information indicating that the Danish market differs

considerably from the EU market it has been assumed that 70-80% of the re-

ceipts of thermal paper used in Denmark contain BPA equivalent to the latest

known EU average.

Analyses of migration of BPA from cash register recei

pts to artificial sweat

Analyses of migration of BPA from receipts to artificial sweat showed that 18

to 37% of the total content of BPA was migrated to the contact media within 5

seconds. Migration varied from 7 to 21 µg/cm

with an average of 14 µg/cm

There was no linear correlation between the content of BPA in the receipts

and the migration rate. None of the receipts differed from the others with a

considerably lower migration rate indicating a topcoat on top of the BPA-

containing surface. This is in correspondence with information from the sup-

pliers that thermal paper with top-coat typically contains BPS as a developer.

If it is assumed tha

t approx. 10 cm

of the receipt is handled for 5 seconds it

can be calculated that approx. 140 µg BPA are migrated by each event.

In the Swiss study, 41 µg BPA on average was migrated to fingers when the

receipts were handled for 5 seconds with wet fingers. If, as in the present

study, it is assumed that the receipt is handled with 8 fingers it corresponds to

a migration of 164 µg BPA.

The measured migration was thus of the same size as found in the Swiss study

when the receipts were handled with entirely wet fingers. As it is not usual to

handle the receipts with wet fingers, 4 of the receipts were selected for further

analyses in a more realistic exposure situation.

Table 4.1

Test results of BPA content in cash register receipts and migration to artificial sweat

BPA content BPA migration

to artificial

sweat

Place of sample Id-nr.

mg/kg µg/cm

** µg/cm

/5 sec

Migration

in % of

content **

Petrol station 1 (payment ma-

chine)

B1 1.4 0.011 n.a. n.a.

Petrol station 2 (payment ma-

chine)

B2 < d.l.* < d.l. n.a. n.a.

Furniture chain B3 < d.l.* < d.l. n.a. n.a.

Toy shop B4 8,700 46 13 28

Grocery chain 1 B5 9,300 61 11 18

Grocery chain 2 B6 11,000 51 19 37

Discount supermarket 1 B7 17,000 77 21 27

Discount supermarket 2 B8 10,000 48 13 27

Bank (cash withdrawal machine) B9 < d.l.* < d.l. n.a. n.a.

Library B10 9,700 53 13 25

Discount supermarket 3 B11 14,000 64 7 10

Hardware store B12 37 0.19 n.a. n.a.

Grocery chain, sticker K1 < d.l. < d.l. n.a. n.a.

Average *** 11,400 57 14 25

* Contained BPS. BPS content is not quantified.

** Area of one side of the receipt.

*** The two lowest values of 1.4 and 37 mg/kg (0.011 and 0.19 µg/cm

) are not included

when calculating the average.

"< d.l." The concentration is below detection limit of 0.1 mg/kg per receipt.

n.a. Not analysed.

Analyses of migration of BPA from cash receipts to fingers

Based on the analyses of migration to sweat the following receipts were se-

lected for further analyses of migration of BPA to fingers: B4, B5, B6 and B7.

Receipts B6 had the highest migration to artificial sweat – the two others were

randomly chosen.

The test results of BPA migration to fingers are shown in Table 4.2. The av-

erage amount migrated to dry fingers (with some natural humidity) were

measured to be 11.3 µg BPA to 8 fingers. There was a considerable variation

a one of the figures was approx. 5 times higher than the others. In the Swiss

study

there was an average migration of 1.13 µg BPA (variation from 0.2 to 6

µg BPA) per finger under standard conditions (slightly oily fingers). If it is

assumed that the receipt is handled by 8 fingers (as in the handling situation,

used in the present study) 9.04 µg BPA would migrate to the skin if the Swiss

results were used.

The results for dry fingers in this study consequently correspond quite well

with the results under standard conditions in the Swiss study.

Migration was approx. 9 times higher when the fingers were humid. On aver-

age 103 µg BPA migrated to 8 humid fingers. There was a considerable varia-

tion with a factor 10 between the lowest and the highest value. The high varia-

tion may partly be due to different degree of humidity on the fingers. As con-

siderable variations in the measurement for dry fingers and sweat simulant

were seen as well there seems to be a considerable degree of mere chance. The

calculated average is consequently encumbered with a considerable uncer-

tainty. The 90% confidence interval on the average can be calculated to be 25-

181 µg BPA.

In the Swiss study the migration to wet fingers was about 35 times higher than

the migration to dry fingers (standard conditions) and the migration to humid

fingers about 15 times higher. The differences compared to the results of the

present study could very well be due to differences in moistness, but also be a

coincidence due to the low number of samples in both studies.

The migration to fingers with hand lotion was approx. 2.5 times the migration

to dry fingers. The Swiss study found that the migration was 9 times higher to

fingers with lotion than at standard conditions. The lower effect of the lotion

seen in the present study could very well be an effect of the fact that fingers

were covered with less lotion than in the Swiss study.

The extraction of BPA from fingers before start of the experiment showed in

the first two tests that 0.07 µg BPA and 0.16 µg BPA could be extracted from

fingers after they have been washed. After the wash upon handling the cash

indicate that BPA is absorbed in the skin and is not washed off. The 0.27 µg

BPA equals 5% of the lowest value measured after handling of the receipts

and 0.3% of the average value for migration of BPA from receipts to humid

fingers which is used in the exposure calculations. This illustrates that even

after thorough washing of fingers with soap there will still be some BPA left

on the skin and also that there have been a risk of transfer a smaller amount of

BPA from one test to the next. The test sequence was dry fingers, humid fin-

gers and fingers with hand lotion so it was not possible to transfer BPA from

the tests with high migration rates of BPA to tests with small migration rates.

Table 4.2

Test results of migration of BPA from cash register receipt to 8 fingers after han-

dling the receipt

Migration after handling receipt

µg BPA *

Place of sample Id-

no.

Dry fingers Humid fin-

gers

Fingers with lotion

Toy shop B4 4.6 21 n.a.

Grocery chain 1 B5 5.4 240 n.a.

Grocery chain 2 B6 30.0 64 26

Discount super market 1 B7 5.3 88 30

Average 11 103 28

n.a. Not analysed.

* At the handling the receipt was touched for 10 sec. and was in contact with

approx. 10 cm

of the skin.

Recovery and absorption in the skin

The results

of the recovery tests showed that after adding a known amount of

BPA 80% and 45% of the applied quantity, respectively, could be extracted.

The low value of 45% of the applied quantity is from the test where 9.7 µg

BPA was applied to 2 fingers. In order to add a sufficient large amount, BPA

was applied as 5 drops where each drop could dry before the next drop was

applied. It took approx. 6 minutes from test start till BPA was extracted from

the fingers. There will be a larger possibility that BPA can be absorbed in the

skin in this test than in the tests with the receipts where the extraction started

10 sec. after the first handling of the cash register receipts. It is thus estimated

that the test where 1.5 µg BPA was applied as one droplet and extracted after

approx. 1 min. gives a more realistic picture of how much of the BPA mi-

grated from the receipts will be extracted. In the test with 1.5 µg BPA there

was a recovery of 80%. In the Swiss study with a similar extraction of 30 sec.

in ethanol, 95% of the applied BPA was retrieved immediate after it had been

applied, 83% after 5 min. and approx 40% after 20 min. and there were no

major change during the period from 20 min. to 2 hours. In those tests the

applied BPA were diluted in ethanol. Tests where the BPA was applied di-

luted in ethanol gave in the present study only a recovery of approx. 50% im-

mediate after the ethanol had vaporized (data not shown) and the test was

therefore repeated with BPA diluted in water which is more like the actual ex-

posure situation.

After 2 hours, 32% and 20%, respectively, of the applied amount could be ex-

tracted. It is far less than found in the Swiss study where 88% of the applied

amount could still be extracted from fingers after 2 hours upon handling a

receipt. When BPA had been applied diluted in ethanol, 40% and 5% could be

extracted depending on the used concentration. The differences may be due

to the fact that in the present test, the fingers were relatively dry without lotion

or oil, whereas the fingers in the Swiss study were slightly oily, but additional

studies would be necessary to clarify the reason for the difference.

The recovery tests indicates that the measured migration of BPA from the re-

ceipts are less than the actual migration, but considering the relatively large

uncertainty on the average values, and the uncertainty as a consequence of

differences in time between adding BPA and extraction, this difference will

not be adjusted. The tests demonstrate that the applied BPA relatively fast is

absorbed in the skin, so it cannot be extracted with ethanol. After 2 hours,

68% and 80%, respectively, of the applied quantity of BPA could not be ex-

tracted. To

what extent the BPA, which is absorbed by the skin will be taken

into the body will be discussed as part of the health assessment in Section 5.2.

Table 4.3

Result of recovery tests

Extraction after addition Extraction after 2 hours Applied BPA to 2 fin-

gers, µg

Extracted BPA,

µg

Extracted in %

of applied BPA

Extracted quan-

tity, µg BPA

Extracted in %

of applied BPA

1.9 1.5 80% 0.6 32%

9.7 4.4 * 45% 1.9 20%

* As BPA had to be applied 5 times, there were approx. 5 min. from start to the fingers were

immersed in ethanol for extraction.

4.2.2 Shield on baby dummies

The result

s of BPA migration from the shield of dummies to artificial sweat

and saliva are shown in Table 4.4.

Migration of

BPA above the detection limit was found to both saliva and

sweat from one of the shields whereas from another shield only migration to

saliva was found. In both cases the concentration in the artificial saliva was

only slightly above the detection limit of 0.1 mg/kg, whereas it was approx. 5

times the detection limit in the artificial sweat.

The only dummy (S5) for which migration to sweat was measured was de-

signed without a ring.

At a previous analysis of migration of BPA from 2 dummies, carried out as a

part of a large study of 2-year-olds’ exposure to chemical substances migra-

tion above the detection limit was only found in one test (Tønning et al.,

2009). In this test the migration was 7 mg/kg material to sweat from one of

the dummies which is approx. 50 times higher than the values found in this

study. In the previous study migration to saliva above the detection limit was

not demonstrated in any of the tests.

Table 4.4

Test results of BPA migration from dummies’ shield to sweat and saliva

Migration of BPA to sweat Migration of BPA to saliva Id-nr. Weight

shield

Surface of

shield

mg BPA

/kg shield

µg BPA

/cm

shield

Total migra-

tion

µg BPA

mg BPA

/kg shield

µg BPA

/cm

shield

Total migra-

tion

µg BPA

S2 - - < d.l. < d.l. < d.l. < d.l. < d.l. < d.l.

S3 - - < d.l. < d.l. < d.l. < d.l. < d.l. < d.l.

S4 7.36 32.0 < d.l. < d.l. < d.l. 0.12 0.028 0.89

S5 8.53 27.8 0.49 0.15 4.17 0.16 0.049 1.36

S6 - - < d.l. < d.l. < d.l. < d.l. < d.l. < d.l.

S7 - - < d.l. < d.l. < d.l. < d.l. < d.l. < d.l.

S8 - - < d.l. < d.l. < d.l. < d.l. < d.l. < d.l.

S9 - - < d.l. < d.l. < d.l. < d.l. < d.l. < d.l.

"< d.l." means below detection limit which is 0.1 mg/kg shield.

5 Health assessment

5.1 Basis of the toxicological assessment

5.1.1 Effect levels and DNEL

Basi

cally the risk assessment is made by comparing the calculated exposure in

a realistic worst case scenario with the Derived No Effect Level (DNEL)

which indicates the exposure level below which no damaging health effects are

expected.

The risk assessment in this project is based on NOAEL (No Observed Ad-

verse Effect Level) derived from the critical effect. REACH applies a DNEL

value calculated based on NOAEL (or similar) and relevant assessment fac-

tors (AF – a kind of correction factors) for calculating the risk.

The DNEL value is derived for bisphenol A (BPA) based on NOAEL ad-

justed by a number of different assessment factors. The assessment factors to

be used depend on which study NOAEL is based on (ECHA, 2010b).

The endpoint-specific DNEL (the value is determined in relation to certain

organs where effects are seen) is based on the following equation:

NOAEL

corr

is the corrected NOAEL value, i.e. the carefully selected NOAEL-

value which the DNEL value is calculated from (ECHA, 2010b).

The assessment factors applied are listed in the table below. The assessment

factors have been established on the basis of the principles in the REACH

guidelines.

Table 5.1

Assessment factors applied for determination of DNEL

Parameter Value Assessment factor

Interspecies Allometric scaling. Corrections for differ-

ences in metabolic rate per kg body

weight.

AS:

4 for rats

7 for mice

Interspecies Remaining differences between different

species

2.5

Intraspecies Individual differences 10

Dose-response LOAEL to NOAEL if LOAEL is applied

because NOAEL is not established

A NOAEL of 5 mg/kg bw/day is based on studies of two generations of ro-

dents where the critical effects were changes in body weight and organ weight

(in breed and adult rats) and liver effects (in mice) (Tyl et al., 2001, Tyl et

al., 2006) as recommended in the updated Scientific Opinion of bisphenol A

from 2010 (EFSA Journal 2010; 8(9):1829).

The total assessment factor is 175 based on a factor of 2.5 for general inter-

species differences, 7 for allometric scaling between mice and humans and 10

for intra

species differences. The assessment factor for rats has not been used

as it is not considered relevant here.

DNEL for bisphenol A is thus 0.029 mg/kg bw/day (NOAEL/AF).

This DNEL will be used for comparison with the estimated dermal and oral

exposure. EFSA has also taken into account the results of later toxicity studies

showing low-dose effects in rodents, e.g. a neurotoxicity study indicating an

effect on learning in male rat offspring in a test following OECD TG 426, and

concluded that these tests did not give reasons to reconsider the NOAEL used

for establishing the TDI. In general, the opinion of EFSA is that the BPA-

related low-dose effects in rats have not been demonstrated in a robust and

reproducible way and thus do not allow a conclusion regarding the toxicologi-

cal relevance for humans. This is also due to the fact that toxic kinetics differs

among the species (how the substances are taken into the body and what hap-

pens to them) and that BPA is less bio-available in humans compared to ro-

dents.

5.1.2 Absorption of BPA after dermal exposure

In the

EU risk assessment of BPA (EC, 2010) it is assumed that only 10% of

the dose applied to the skin is absorbed in the body liquids. The percentage is

based on an unpublished draft report (In Vitro Technologies, 2001), where 5

and 50 mg BPA/cm

were applied to skin samples, respectively. It should be

noted that the applied quantities are approx. 1000 times larger than the

amounts applied to the skin when handling cash register receipts.

A recent survey of BPA’s ability to penetrate the skin gave a similar result

(Kaddar et. al, 2008). In the study the penetration to pig skin was examined

using a so-called ”Franz cell”. Skin that had been frozen was used in the

study. After 2, 5 and 10 hours of exposure the intake of BPA to the skin was

3, 6.9 and 11.4% of the applied dose, respectively. The BPA that penetrated

the skin surface mainly accumulated in the dermis. After 10 hours 65% of the

applied BPA was still on the skin surface. The test lasted 10 hours because

this is the maximum period the workers handle BPA in their working envi-

ronment. The authors assume that hereafter BPA is removed from the skin.

In a new French study, diffusion and metabolism of BPA have been examined

using skin cultures and viable human skin explants and short-term cultures of

skin from pig ears (Zalko et al., 2011). BPA was effectively absorbed in both

skin model with 68% absorbed in pig ears skin and 46% in the viable human

explants. BPA was extensively metabolised in both models whereas the same

did not apply if the samples had been made non-viable by freezing. The most

important metabolites was BPA mono glucuronide and BPA mono sulphate

which totals 73% and 27% in skin from pig ears and the human explants, re-

spectively. The authors note that some of the metabolites have less estrogenic

activity than BPA so that the metabolism to some extent may be considered as

detoxification. At the same time it is also possible that the BPA conjugates are

transformed to BPA before or when they reach the target organs. The authors

conclude that the study demonstrates that BPA is readily absorbed and is me-

tabolized in the skin and that contact with the free monomer contributes to

the human exposure to BPA. The trans-dermal absorption (absorption trough

skin) was not determined in this test.

Based

on this information it is assumed that dermal absorption may account

for 50% of the applied amount and not only 10% as considered in the EU risk

assessment. Both absorption factors are used in the calculations.

5.2 Cash register receipts

5.2.1 Exposure

Exposure of consumers

In order to c

alculate the internal dermal exposure of consumers (the amount

absorbed in the body via the skin) values for total migration to the skin per

unit area and time are used as well as exposed skin surface and exposure time

per event, number of events and a factor for the dermal absorption.

For the Tier 1 scenario the average measured migration for 5 seconds was

0.014 mg/cm

corresponding to a migration rate of 0.0028 mg/cm

/sec. The

calculation, based on studies of migration to sweat, is a first rough assessment

of the potential exposure which is refined with the realistic worst case sce-

nario.

In the realistic worst case scenario used in this study, the average migration to

humid fingers based on analysis were 103 µg/kg for an exposure of 10 cm

fingers) for 10 seconds corresponding to a migration rate of 0.00103

mg/cm

/sec.

Parameters and results of the dermal exposure scenarios are shown in Table

5.2. The maximum internal dose D

der, int,

in the worst case scenario for consum-

ers has been calculated to be 0.004 mg/kg bw/d equivalent to a dose of 0.24

mg/d for a 60 g person. The formula for calculation of D

der, int,

is shown in sec-

tion 3.2.

Table 5.2

Input and output parameters for dermal exposure scenarios for cash register receipts

Input

parameter

Tier 1 scenario

based on migra-

tion to sweat

simulant

Realistic worst case

scenario based on

measured migra-

tion to humid fin-

gers

Realistic worst

case scenario for

cashiers based

on measured

migration to hu-

mid fingers

Unit

Migr. 0.0028 0.00103 0.00103 mg/cm

contact

(default)

1 1 1 cm

/cm

contact

10 10 5 s

skin

10 10 5 cm

BW 60 60 60 kgbw

N 4.6 4.6 100 d

-1

abs

* 10/50 10/50 10/50 %

Output

parameter

Unit

der

0.028 0.028 0.0103 mg/cm

der

0.021 0.021 0.0079 mg/kgbw/d

der, int

* 0.0021/0.0107 0.0021 / 0.0107 0.0008 / 0.004 mg/kgbw/d

* D

der, int

is calculated based on 10% uptake and 50% uptake.

When calcul

ating the dermal exposure of cashiers based on a very conserva-

tive scenario as shown in Table 5.2, assuming that the person have humid fin-

gers all

day and 100 individual contact events where the receipt is touched for

5 seconds with a contact surface of 5 cm

. Based on these assumptions the

internal dermal load is calculated at 0.0043 mg/kg bw/day and 0.0215 mg/kg

bw/day for 10% and 50% uptake respectively.

In relation to the exposure of the consumer it is reasonable to assume that

each event is independent on the previous event, but this do not seem to be

the case for cashiers handling a large number of receipts daily. The key ques-

tion is whether BPA on the skin surface limits additional intake of BPA to skin

from the receipts that are handled after each other. This will be discussed fur-

ther in the health risk assessment.

5.2.2 Health risk assessment

Consu

mers

The risk characterisation ratio, RCR, shows the relation between the calcu-

lated absorption of the substance (the internal dose) and the DNEL which is

the exposure level below which no damaging health effects are expected.

When RCR is below 1, the exposure is considered not to cause any risk. In

order to consider other sources for exposure and that the RCR should be cal-

culated based on the total exposure to BPA, an estimate have been made of

other contributions to the BPA-load.

In the EU risk assessment report (EC, 2010) is presented some conservative

estimates of the average consumer exposure in the EU via the diet. The esti-

mates are shown in Table 5.3. The daily intake of BPA with food is estimated

at 1.5 µg/kg

bw/day). For a person of 60 kg this corresponds to 90 µg

BPA/day. An oral intake rate of 100% has been used.

Table 5.3

Conservative estimate of total dietary exposure of adults to BPA (EU risk assessment).

Age of

consumer

Source of exposure

Dietary exposure to BPA based on conservative

migration value in µg/kg bw/day

Adult

3 kg canned

foods/beverages

1.25

Adult

Migration from polycar-

bonate tableware and stor-

age containers

0.25

Adult

Potential dietary exposure

from all sources

1.5

Risk characterisation

RCR

diet

DNEL: 0.029 mg/kg

bw/day

0.052

RCR is calculated for the two consumer exposure scenarios based on a dermal

absorption rate of 10% and 50% respectively and the results are shown in

Table 5.4. The Tier 1 estimation for consumer exposure is shown as well.

can be seen from Table 5.4, that the RCR for exposure of receipt is well

below 1

for both the Tier 1 estimate and the two consumer exposure scenar-

ios where the exposure is based on very conservative assumptions.

When calcul

ating RCR from exposure to both food and cash register receipts

(RCR

total

) for the two worst case consumer scenarios, RCR is still below 1

(0.08 and 0.19, respectively) and based on these assumptions the exposure of

BPA to receipts is not considered to constitute a risk.

Furthermore, it can be seen from Table 5.4 that the RCR

dermal

in the worst case

scenario is of the same magnitude as the RCR

diet

based on conservative as-

sumptions of the average consumer exposure of BPA in food in the EU. The

results show that the exposure to cash register receipts potentially may result

in absorption of the same magnitude as intake with food. Based on new stud-

ies of the relation between absorption of BPA and BPA-concentration in

blood serum in mice and monkeys, American scientists conclude that a level

of non conjugated BPA (i.e. BPA not bound to other substances) in blood

serum of approx. 2 ng/ml serum, which has been found in several studies of

humans, indicates that the total exposure of BPA from different sources are

considerably higher than previously assumed (Taylor et al., 2010). BPA in

receipts may potentially be one of the sources which previously have been un-

derestimated.

Table 5.4

Calculation of RCR for BPA exposure to consumers in receipts and food

Output parameter Tier 1 scenario

estimate based on

migration to

sweat simulant

Realistic worst case sce-

nario based on meas-

ured migration to wet

fingers

Unit

der

0.028 0.0103 mg/cm

der

0.021 0.0079 mg/kgbw/d

der, int

0.0021 / 0.0107 0.0008 / 0.004 mg/kgbw/d

DNEL 0.029 0.029 mg/kgbw/d

RCR

dermal

0.07 / 0.37 0.03 / 0.14 -

RCR

diet

0.052 0.052 -

RCR

total

0.13 / 0.42 0.08 / 0.19 -

Other sources of exposure relevant for consumers are considered in the EU

risk assessment report, e.g. dermal exposure to epoxy resin based adhesives,

oral exposure to dental fissure sealants, and exposure to humans via the envi-

ronment. For all endpoints (i.e. specific organs where effects are seen) as-

sessed in the EU risk assessment the conclusion was that exposure from these

sources are very low.

Cashiers

The dermal RCR is calculated for two very conservative cashier scenarios

based on a dermal uptake of 10% and 50% respectively and the results are

shown in Table 5.5. As in the consumer scenarios, the contribution from die-

tary exposure is added and the combined RCR has been calculated.

Table 5.5

Calculation of the risk characterisation ratio for BPA exposure to cashiers

Output parameter worst case scenario for

cashiers

Unit

der

0.0052 mg/cm

der

0.043 mg/kgbw/d

der, int

0.0043 / 0.0215 mg/kgbw/d

DNEL 0.029 mg/kgbw/d

RCR (D

der

/ DNEL) 0.15 / 0.74 -

RCR

diet

0.052 -

RCR

total

0.2 / 0.79 -

As it can be seen from the table, RCR

total

is less than 1 for both the scenario

with 10% and the scenario with 50% dermal absorption rate.

As mentioned previously, it is a key question for the exposure of the cashiers

to what extent BPA on the skin surface limits the uptake of BPA from cash

the amount of BPA on the skin does not increase by contact with additional

receipts. In a test with standard conditions the average amount of BPA trans-

ferred to the skin of one finger was 1.2 µg BPA. After touching 10 receipts the

average quantity transferred was 1.0 µg BPA. There was no effect of touching

a receipt for 60 sec. instead of 5 sec. On this basis the authors conclude that

the cashiers somehow maintain a constant amount of BPA on the fingers. A

test showed that 2 hours after touching the thermal paper the amount ex-

tracted was 88% of the quantity that could be extracted immediately after

touching the receipt. This could indicate that the absorption via the skin is not

a fast process but as only one test was made, the result is considered to be

very uncertain. Based on the results the authors assume that there will con-

stantly be approx. 3 µg BPA per finger and that 27% of this is taken up in 2

hours, i.e. a constant absorption rate of 0.41µg BPA per finger. During a

working day of 10 hours where the receipts are touched with 10 fingers the

total BPA uptake is estimated at 41 µg BPA. If the hands are not washed be-

fore going home additionally 30 µg BPA will be left on the fingers which could

also be resorbed. The total uptake under standard conditions (moisturized

skin) has been estimated at 71 µg BPA/day. This amount is considerably

lower than the amount calculated in the present study (up to 1,290 µg

BPA/day) which is partly due to the fact that the present study considers a

worst case situation where the receipts are touched with humid hands and

each event are considered independent of the previous event.

Whether BPA is absorbed further in the body is uncertain, but the results of

the Swiss study shows that BPA after a while can no longer be washed off

which gives the substance plenty of time to be absorbed via the skin or me-

tabolized. This is also in accordance with the results of this study showing that

only a small amount of the applied BPA can be extracted from fingers after 2

hours.

A new American study of BPA concentration in urine from 389 pregnant

women found the highest average values for different occupational groups in a

group of cashiers (Braun et al., in press). The average value (geometric mean)

for 17 cashier workers were 2.8 µg BPA/g creatine whereas the value for

workers in the health sector and office workers was 2.1 µg BPA/g creatine.

Due to the large variation the differences were not at a 95% significant level

even when data were

adjusted for socio-economic factors. The authors also

mention that the results should be interpreted cautiously. Apart from cashier

work a high content of BPA in urine was positively associated with the intake

of canned vegetables, exposure to tobacco smoke and to high molecular

weight phthalates.

There is no doubt that cashiers potentially have a higher exposure to BPA

than consumers as they are in contact with a significantly more cash register

receipts during a day. However, it is not clear to what extent the number of

contact events influence the total uptake of BPA as there is some indication

that the skin is saturated at a certain point, but there is no available informa-

tion about the actual uptake via the skin over time.

Although the combined RCR in this scenario is closer to the DNEL than in

the consumer scenarios the conclusion, based on this very conservative esti-

mate, is that the exposure does not cause any concerns with regard to the risk

for cashiers.

5.3 Dummies

5.3.1 Exposure

In order to c

alculate the worst case internal dermal and oral exposure of chil-

dren between 0 and 3 years, the total dermal and oral load per handling event

are calculated based on migration per unit area of the shield and time. The

body weight of a 1-2 month old baby of 4.5 kg is used for calculation.

The migration to sweat was measured at 0.15 g/cm

per 7.75 hour corre-

sponding to 0.019 g/cm

/h (shield S5).

The maximum migration to saliva was measured at 0.049 g/cm

per 7.75

hour corresponding to 0.0063 g/cm

/h (shield S5).

The input and output parameters for dermal scenario are shown in Table 5.6.

Table 5.6

Input and output parameters for dermal exposure scenario for dummies

Input parameter worst case scenario

for dermal exposure

based on migration to

sweat simulant

Unit

Migration to sweat Migr.

0.019 g/cm

Fraction of contact

with saliva

contact

0.25

/cm

Contact

duration

contact

7.75

Surface of shield

shield

27.8 cm

Dermal absorption

factor

abs

10 / 50

Body weight of a 1-

2 month old baby

4.5

Events per day, n Events per day, n 1 d

-1

Output

parameter

Unit

Dermal load L

der

0.00015 mg/cm

Dermal dose

der

0.00023 mg/kgbw/d

Internal dermal

dose

der, int

0.000023 / 0.00012

mg/kgbw/d

* For most dummies the surface would also include a ring, but this dummy was designed

without a ring, but the shield had a relatively large surface that could be in contact with

skin.

** D

der, int

is calculated based on 10% uptake and 50% uptake.

The input and output parameters for the oral scenario are shown in Table 5.7.

Table 5.7

Input and output parameters for the oral exposure scenario for dummies

Input parameter worst case scenario for

oral exposure based on

migration to saliva

simulant

Unit

Migration to saliva Migr.

0.0063 g/cm

Fraction of contact

area for saliva

contact

0.25 cm

/cm

Contact

duration

contact

7.75

Hour

Surface of shield S

shield

27.8 cm

Oral absorption F

abs

100 %

Body weight of a 1-2

month old baby

BW 4.5 Kg

Events per day n 1 d

-1

Output

parameter

Unit

Oral load L

oral

0.000049 mg/cm

Oral dose

oral

0.00008 / 0.00003 mg/kgbw/d

Internal oral dose D

oral, int

0.00008 / 0.00003 mg/kgbw/d

5.3.2 Health risk assessment

In the

EU Risk Assessment Report (EC, 2010) the daily oral intake of BPA

with food is estimated at 8 µg/kg bw/day) for a 1-2 month old baby of 4.5 kg

corresponding to 35 µg BPA/day. RCR

diet

is based on intake of BPA from

baby bottles made of polycarbonate.

The calculated RCR

diet

is shown in Table 5.8 and this is added to the total

dermal and oral RCR for dummies to provide a more complete picture of the

potential exposure and risk.

The risk characterisation ratio is calculated for the two scenarios based on mi-

gration of BPA to sweat and saliva simulant. A calculation of the total expo-

sure has also been made considering other sources. The internal dermal expo-

sure is calculated based on a dermal uptake of 10% and 50% respectively and

the results are shown in Table 5.9.

Table 5.8

Conservative estimate of total dietary exposure of a 1-2 month old baby to BPA

Age of

consumer

Source of exposure

Dietary exposure to BPA based on conservative

migration value in µg/kg bw/day

1-2 month old

baby

Infant feeding bottles

Risk characterisation

RCR(diet)

DNEL: o.o29 mg/kg

bw/day

0.276

It can be seen in Table 5.9 that RCR for both dermal and oral exposure and

the combined RCR is considerably below 1 based on a conservative estimate.

In comparison, the estimated oral intake with food, in this case from polycar-

bonate baby bottles, is considerably higher.

When

RCR for intake with food, which is much higher than the RCR calcu-

lated based on exposure to BPA in dummies, is added the total RCR is 0.28

no matter which absorption factor is used.

Table 5.9

Calculation of the risk characterization ratio for BPA exposure to children

Output parameter worst case scenario

for dermal exposure

based on migration to

sweat simulant

worst case scenario for

oral exposure based on

migration to saliva simu-

lant

Unit

der

0.00015 0.000049 mg/cm

der

0.00023 0.00008 mg/kgbw/d

der, int

0.000023 / 0.00012 0.00008 mg/kgbw/d

DNEL 0.029 0.029 mg/kgbw/d

RCR

dermal

(sweat) 0.0008 / 0.002 -

RCR

oral

(saliva) - 0.0026

RCR

oral+dermal

0.0034/0.0046

RCR

diet

0.276

RCR

total

0.279 / 0.281

5.4 Summary and conclusion

The result

s of this study show that there is no immediate health risk related to

use of BPA-containing cash register receipt and baby dummies.

For exposure to BPA in receipts, RCR is far below 1 for worst case scenario

exposure of consumers and according to the REACH guidelines for consumer

exposure there is thus no relevant risk related to the exposure.

Exposure to cashier workers the highest RCR is still below 1. However, small

changes in the assumptions will make it above 1. The calculated exposure

with worst case scenario is by far higher than the exposure found in an earlier

Swiss study where the exposure was not estimated for a worst case situation,

but rather a typical situation and where it is also taken into account that the

skin at a certain time is saturated so smaller amounts of BPA migrate to the

skin. When RCR is still below 1 with the used worst case scenario it should

then be concluded that there seems to be no health risk for cashier workers.

The calculated exposure to BPA in dummies is far below the exposure to

BPA in baby bottles and the calculated RCR for exposure to BPA in dummies

only contributes insignificantly to the total RCR when other sources are in-

cluded.

The health assessment is based on a NOAEL value based on existing knowl-

edge, but lately there have been results questioning whether health effects may

occur at smaller doses than previously considered. The European Food Safety

Authority, EFSA has concluded that new studies of low-dose effects of BPA

do not give sufficient documentation that exposure from these doses could

cause effect at humans and concluded that the no-observed-adverse-effect

level (NOAEL) of 5 milligram/kg body weight/day identified in the previous

evaluation in 2002, remains. At the moment the suspicion of effects from

small doses of BPA cannot be rejected, but in this study NOAL is set as rec-

ommended by EFSA.

matter the results of this study it is worth to note that BPA has been classi-

fied as an endocrine system disruptor with the hazard classification Repr.2,

H361f: ”Suspected of damaging fertility“. The substance is also on the Dan-

ish EPA’s “List of undesired substances”, a signal list and guidance to com-

panies about problematic substances and use which should be reduced or

terminated in the long term. Alternatives to cash register receipts are available,

but it has not been investigated to what extent the alternative developers are

better than BPA from an environmental and health perspective and the costs

of changing to the alternatives is unknown. Parts of the Danish retail trades

have informed, that the price for paper with the alternative developer bisphe-

nol S is approximately twice as expensive as BPA based paper, while thermal

paper without phenol-chemistry is claimed to be four times the price for paper

with BPA. At present the health risks of papers with alternative developers is

unknown. Alternatives to baby dummies made of polycarbonate today ac-

count for the major part of the market.

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Appendix 1 Koehler’s assortment of

thermal paper

POS = point of scale

Appendix 2 Mitsubishi’s assortment

of thermal paper

Appendix 3 Dummies sold in Danish

internet shops

As part of Phase 1 in this project a search was carried out for Danish internet

shops (or internet departments of other shops) selling dummies. This search

was made in the beginning of September 2010. It is not a thorough mapping

as the intention of the mapping was mainly to identify a sufficient number of

labels with a shield of poly carbonate.

The following internet suppliers and range of dummies were found at the

search:

Light grey background: Shield material not listed.

Dark grey background: Shield of poly carbonate.

White background: Entire dummy made of latex or shield of polypropylene

Net shop Product name Material Web address Comment/

Labelling

www.vismaa.dk/group

.asp?group=6

Hevea Sut Latex (the whole

dummy)

http://www.vismaa.

dk/group.asp?grou

p=6

European standard

EN 1400

www.superbest.dk NUK (Germany),

anatomic dummy,

Classic

shield: ?, nipple:

latex

http://www.superbe

st.dk/produkt/nuk-

classic-sovesut-06-

European standard

EN 1400

www.superbest.dk BIBS dummy with

valve

shield: polypropyl-

ene, nipple: latex

http://www.superbe

st.dk/produkt/rund-

sut-str2-dreng-

pastel

European standard

EN 1400

www.bambino-

mam.se/dk

NAM (Austria) Mini shield: polypropyl-

ene, nipple: latex

http://www.bambino

mam.se/dk/bambin

omam/show.php?id

=25245

BPA free

www.bambino-

mam.se/dk

NAM (Austria)

Classic

shield: polypropyl-

ene, nipple: latex

http://www.bambino

mam.se/dk/bambin

omam/show.php?id

=25247

www.bambino-

mam.se/dk

NAM (Austria) Air

og Air Maxi Sut

shield: polycarbon-

ate, nipple: latex or

silk teat

http://www.bambino

mam.se/dk/bambin

omam/show.php?id

=25249

www.babyshoppen.co

Nûby™ (USA) shield: ?, nipple:

silicone

http://www.babysho

ppen.com/shop/2-

stk-anatomisk-

EU product safety

directive

2001/95/EC, has

CE label, PVC and

Net shop Product name Material Web address Comment/

Labelling

347p.html phthalate free

www.babyshoppen.co

Tolico (Denmark) shield: polycarbon-

ate, nipple: latex

http://www.babysho

ppen.com/shop/3-

stk-anatomisk-

350p.html

EU Standard EN

1400, PVC and

phthalate free

www.dreamchild.dk Chicco Latex (the whole

dummy)

http://www.dreamch

ild.dk/default.asp?n

umr=9016&vari=Mi

ni%200

Contains no aller-

gens nor carcino-

gens

www.dreamchild.dk AVENT (Phillips)

Sensitive

shield: ?, nipple:

silicone

http://www.dreamch

ild.dk/default.asp?n

umr=9016&vari=Mi

ni%200

BPA free

www.dreamchild.dk Pussycat shield: polypropyl-

ene, nipple: latex

http://www.dreamch

ild.dk/default.asp?n

umr=9016&vari=Mi

ni%200

Dansk Varefakta

(Danish informative

labelling)

www.helsebixen.dk BornFree™ shield: ?, nipple:

silicone

http://www.helsebix

en.dk/shop/sutter-

flasker-m-m-

337c1.html

100% free of

bisphenol A, PVC

and phthalates

www.navnesutten.dk Deluxe name

dummy

shield: polycarbon-

ate, nipple: latex

http://www.navnesu

tten.dk/Products.as

px?SalesArticleID=

2072

EU Standard EN

1400, free of PVC

and phthalate

www.navnesutten.dk NIP (Germany) shield: polycarbon-

ate, nipple: latex

http://www.navnesu

tten.dk/Products.as

px?SalesArticleID=

7072

EU Standard EN

1400, free of PVC

and phthalate

www.navnesutten.dk AVENT (Phillips)

Freeflow

shield: polycarbon-

ate, nipple: silicone

http://www.navnesu

tten.dk/Products.as

px?SalesArticleID=

4073

EU Standard EN

1400, free of PVC

and phthalate

www.navnesutten.dk Esska (Sweden),

Anatomisk

shield: polycarbon-

ate, nipple: latex

http://www.navnesu

tten.dk/Products.as

px?SalesArticleID=

5016

EU Standard EN

1400, free of PVC

and phthalate

www.navnesutten.dk Esska (Sweden),

Ellipse, flat

shield: polycarbon-

ate, nipple: latex

http://www.navnesu

tten.dk/Products.as

px?SalesArticleID=

EU Standard EN

1400, free of PVC

and phthalate

www.navnesutten.dk Esska (Sweden),

Happy, flat

shield: polycarbon-

ate, nipple: latex

http://www.navnesu

tten.dk/Products.as

px?SalesArticleID=

EU Standard EN

1400, free of PVC

and phthalate

www.navnesutten.dk Nûby (USA), Air,

flat

shield: polycarbon-

ate, nipple: silicone

http://www.navnesu

tten.dk/Products.as

px?SalesArticleID=

EU Standard EN

1400, free of PVC

and phthalate

Net shop Product name Material Web address Comment/

Labelling

paradisvej.com Elodie Details

(Sverige)

shield: ?, nipple:

silicone

http://paradisvej.co

m/product.asp?pro

duct=3801

EU standard EN-

1400

www.detbedstetilbaby

.dk

Apotekets Sut shield: ?, nipple:

latex

http://www.detbedst

etil-

baby.dk/sider/apote

kets-

narresut_97.aspx

Dansk Varefakta

(Danish informative

labelling), EU stan-

dard 1400

www.babysam.dk MEDA narresut ? http://www.babysa

m.dk/meda-

narresut-i-love-

mom.aspx

www.babysam.dk Disney narresut shield: ?, nipple:

silicone

http://www.babysa

m.dk/disney-

narresut-

silikone.aspx

www.babysam.dk Round dummies shield: ?, nipple:

silicone

http://www.babysa

m.dk/basic-

sutter.aspx

baby-vest.dk Avent Naturally shield: ?, nipple:

silicone

http://baby-

vest.dk/diverse-

tilbehoer-

100/flasker-og-

sutter-131/avent-

narresut-0-3-mdr-

430.html

Dansk Varefakta

(Danish informative

labelling)

www.matas.dk Narresut shield: ?, nipple:

latex

http://www.matas.d

k/graviditet+boern/b

aby-

+smaaboernstilbeh

oer/sutter/narresut+

2+stk+til+drenge.as

px?categoryid=635

&productid=3452

Dansk Varefakta

(Danish informative

labelling)