rohs annex ii dossier for bbp

Substance Name: Benzyl butyl phthalate

EC Number(s): 201-622-7

CAS Number(s): 85-68-7

Vienna, October 2013

ROHS ANNEX II DOSSIER FOR BBP

Proposal for restriction of a substance in electrical and electronic

substances under RoHS

ROHS Annex II Dossier for BBP

Vienna, October 2013 3

CONTENTS

CONTENTS ........................................................................................... 3

1 IDENTIFICATION, CLASSIFICATION AND LABELLING ............................................................................... 5

1.1 Name, other identifiers and physico-chemical properties of the substance .................................................................................... 5

1.1.1 Name, other identifiers and composition of the substance ..................... 5

1.1.2 Physico-chemical properties ................................................................... 6

1.2 Classification and Labelling Status .................................................... 6

1.3 Legal status and use restrictions ........................................................ 8

2 USE OF THE SUBSTANCE ..................................................... 10

2.1 Use and function of BBP in general .................................................. 10

2.2 Use of BBP in EEE .............................................................................. 10

2.3 Quantities of BBP in EEE ................................................................... 10

3 HUMAN HEALTH ..................................................................... 11

3.1 Human health hazard assessment .................................................... 11

3.1.1 Endpoints of concern ............................................................................ 11

3.1.2 Existing Guidance values ...................................................................... 14

4 ENVIRONMENT ....................................................................... 16

4.1 Environmental fate properties ........................................................... 16

4.2 Environmental hazard ......................................................................... 17

4.2.1 Eco-toxicity studies ............................................................................... 17

4.2.2 Potential for secondary poisoning ......................................................... 18

4.2.3 Existing guidance values (PNECs) ....................................................... 18

5 WASTE MANAGEMENT OF ELECTRICAL AND ELECTRONIC EQUIPMENT .................................................... 19

5.1.1 WEEE categories containing BBP ........................................................ 19

5.1.2 Relevant waste materials/components containing BBP ....................... 19

5.2 Waste treatment processes applied to WEEE containing BBP ....................................................................................................... 19

5.2.1 Treatment processes applied ................................................................ 19

5.2.2 BBP flows during treatment of WEEE ................................................... 20

5.2.3 Treatment processes selected for assessment under RoHS ............... 22

5.3 Releases from the relevant WEEE treatment processes ................ 23

5.3.1 Shredding of WEEE .............................................................................. 23

5.3.2 Summary of releases from WEEE treatment ........................................ 26

6 EXPOSURE ESTIMATION ....................................................... 27

6.1 Human exposure ................................................................................. 27


4 Vienna, October 2013

6.1.1 Exposure estimates of workers of EEE waste processing plants Exposure estimates of workers of EEE waste processing plants ..................................................................................27

6.2 Environment exposure .......................................................................29

6.2.1 Exposure estimates for the environment due to WEEE treatment ...............................................................................................30

6.2.2 Monitoring data: WEEE treatment sites/locations .................................32

7 IMPACT AND RISK ESTIMATION ........................................... 33

7.1 Impacts on WEEE management as specified by Article 6(1) a .....................................................................................................33

7.2 Risks estimation for workers and neighbouring residents ............33

7.3 Risks estimation for the environment ...............................................33

8 ALTERNATIVES ...................................................................... 35

8.1 Availability of alternatives ..................................................................35

8.2 Hazardous properties of alternatives ................................................35

8.3 Conclusion on alternatives ................................................................37

9 SOCIO-ECONOMIC IMPACT ANALYSIS ................................ 38

9.1 Approach and assumptions ...............................................................38

9.2 Impact on producers of plasticisers and plastics ...........................39

9.3 Impact on EEE producers ..................................................................40

9.4 Impact on EEE users ..........................................................................40

9.5 Impact on waste management ...........................................................41

9.6 Impact on administration ...................................................................41

9.7 Total socio-economic impact .............................................................41

10 RATIONALE FOR INCLUSION OF THE SUBSTANCE IN ANNEX II OF ROHS ............................................................ 43

11 REFERENCES ......................................................................... 47

12 ABBREVIATIONS .................................................................... 50

13 LIST OF TABLES ..................................................................... 51

14 LIST OF FIGURES ................................................................... 52



1 IDENTIFICATION, CLASSIFICATION AND LABELLING

1.1 Name, other identifiers and physico-chemical properties of the substance

1.1.1 Name, other identifiers and composition of the substance

Table 1: Substance identity and composition (Source: ECHA, 2008)

Chemical name Benzyl butyl phthalate

EC number 201-622-7

CAS number 85-68-7

IUPAC name Benzyl butyl phthalate

Index number in Annex VI of the CLP Regulation

607-430-00-3

Molecular formula C19H20O4

Molecular weight range 312,35

Synonyms 1,2-benzenedicarboxylic acid, butyl phenylmethyl ester; benzyl-n-butyl phthalate; phthalic acid, butyl benzyl ester; Santicizer 160; Sicol 160; Unimoll BB

Structural formula

Degree of purity > 95.5% (w/w)

Remarks --



1.1.2 Physico-chemical properties

The physical chemical properties of BBP are summarised in Table 2.

Table 2: Physico-chemical properties of BBP (Source: ECHA, 2008)

Property Value

Physical state at 20°C and 101.3 kPa liquid

Melting/freezing point <-35°C

Boiling point 370°C at 10.10 hPa

Vapour pressure 0.00112 Pa at 20°C

Water solubility 2.8 mg/l

Partition coefficient n-octanol/water (log POW) Log Kow 4.84

Flashpoint 198°C (390°F)

Autoignition temperature 425°C

Density (25°C) 1.116 g/cm3

Henry´s law constant (calculated) 0.176 Pa*m3mol-1

1.2 Classification and Labelling Status

The Classification, Labelling and Packaging (CLP)1 regulation requires compa-nies to classify, label and package their substances and mixtures before placing them on the market.

The regulation aims to protect human health and the environment by means of labelling to indicate possible hazardous effects of a particular substance. It should therefore ensure a proper handling, including manufacture, use and transport of hazardous substances.

BBP is listed in Annex VI of the CLP Regulation and is harmonised classified as depicted in Table 3.

In accordance with Directive 67/548/EEC BBP is classified as Repr. Cat. 2; R61 (may cause harm to the unborn child); Repr. Cat. 3; R62 (possible risk of im-paired fertility); N; R50-53 (very toxic to aquatic organisms-may cause long-term adverse effects in the aquatic environment) and labelled with the symbols T,N and R61, R62, R50/53; S53, S45, S60, S61.

Additionally to the harmonised classification BBP is self-classified as Acute Tox. 3 (H331) by some manufactures and/or importers. This information has been obtained from the C&L inventory provided by ECHA.2

1 Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification,

labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006

2 for details see: http://echa.europa.eu/web/guest/information-on-chemicals/cl-inventory-database

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Table 3: Harmonised classification of BBP1

Index No

International Chemical Identifi-cation

EC No CAS No

Classification Labelling Spec. Conc. Limits, M-factors

Notes

Hazard Class and Category Code(s)

Hazard state-ment code(s)

Pictogram, Signal Word Code(s)

Hazard statement code(s)

Suppl. Hazard statement code(s)

607-430-00-3

BBP

benzyl butyl phthalate

201-622-7

85-68-7

Repr. 1B

Aquatic Acute 1

Aquatic Chronic 1

H360Df

H400

H410

GHS09

GHS08

Dgr

H360Df

H400

H410

-- -- --

1 Classification according to part 3 of Annex VI, Table 3.1 (list of harmonized classification and labelling of hazardous substances) of the CLP Regulation Regulation (EC) No 1272/2008 of the

European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and

1999/45/EC, and amending Regulation (EC) No 1907/2006



1.3 Legal status and use restrictions

REACH Regulation 3,4

BBP is included in Annex XIV - list of substances subject for authorisation - of the Regulation No. 1907/2006. Specific authorisation for BBP will be required for a manufacturer, importer or downstream user to place the substance on the market, use it in preparations or for the production of articles. BBP cannot be placed on the market or used after 21st of February 2015, unless an authorisa-tion is granted for the specific use or the use (e.g., medical devices) is ex-empted for authorisation.

Furthermore, there are specific restrictions for certain phthalates in toys and and childcare articles. BBP is included in Annex XVII (restrictions on the manu-facture, placing on the market and use of certain dangerous substances, prepa-ration and articles) of the Regulation No. 1907/2006 (Annex XVII, group 51).

Following restriction conditions have to be taken into consideration for three phthalates, including BBP:

� in toys and childcare articles BBP, Bis(2-ethylhexyl)phthalate (DEHP), and Dibutyl-phthalate (DBP) shall not be used as substance or in mixtures in con-centrations greater than 0.1 % by weight of plasticised material;

� toys and childcare articles containing BBP, DEHP, and DBP in a con-centration greater than 0.1 % by weight of plasticised material shall not be placed on the market.

Food Contact Material Regulation5

In the European Union certain restrictions on the use of BBP in food contact materials are implemented.

BBP can be only used as plasticiser in repeated use materials and articles. In single-use materials and articles contacting non-fatty foods BBP can be used with exemptions for articles containing foodstuffs for infant, baby and young children.

However, the migration of the plasticiser should not exceed the Substance Mi-gration Limit (SML) of 1.5 mg/kg food.

Furthermore it can be used as technical support agent in concentrations up to 0.1% in the final product.

3 Commission Regulation (EU) No 143/2011 of 17 February 2011 amending Annex XIV to Regula-

tion (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Eval-uation, Authorisation and Restriction of Chemicals (‘REACH’)

4 Corrigendum to Commission Regulation (EU) No 143/2011 of 17 February 2011 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Reg-istration, Evaluation, Authorisation and Restriction of Chemicals ( ‘REACH’ )

5 Commission Regulation (EC) No 10/2011 of 14th January 2011 on plastic materials and articles intended to come into contact with food



Cosmetic regulation6

BBP is prohibited to be used for the production of cosmetic products. It is listed in Annex II – list of substances prohibited in cosmetic substances- to the Cos-metic Regulation.

6 Regulation (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of

30 November 2009 on cosmetic products



2 USE OF THE SUBSTANCE

2.1 Use and function of BBP in general

BBP is used as plasticiser in minor concentrations in flexible polymers (e.g. PVC) as well as in some non-polymers (e.g., adhesives, paints, sealants, print-ing inks) (COWI, IOM and Entec, 2009). It is used together with other plasticis-ers to add special properties to the intermediate and end product including faster gelation of the polymer or hard and stain resistant surface of the polymer.

Phthalates are not bound chemically in the polymer matrix (external plasticis-ers). The substance group can therefore migrate from the plasticised polymer by e.g. extraction with soapy water/oils, by evaporation and by diffusion (DEPA, 2010).

2.2 Use of BBP in EEE

BBP is mainly used as plasticiser in PVC flooring. The usage in EEE has not been confirmed (DEPA, 2010).

However, it might be assumed that BBP is present in EEE in following applica-tions: synthetic leather, coated textile, flexible or rigid PVC sheets, printing inks, sealants and adhesives. These applications might be used in various product types including electric devices.

2.3 Quantities of BBP in EEE

The market for BBP has been decreasing over the last decades indicating that BBP is replaced by alternatives. The overall production in the EU in 2007 was below 18,000 t/y. 70% of the BBP is used in polymer production, mainly for PVC flooring. It is used in the flooring industry because of its properties to speed up production (faster gelation of polymer) and its properties to build a specific floor surface.

Information on the use of BBP in the EEE production is scarce.

For the purpose of the present assessment the BBP quantity entering the Euro-pean market via EEE was estimated as follows:

DEPA (2010) estimates the amount of BBP used in EEE produced within the EU to be 20 to 200 tonnes per year. When assuming that ten times as much of BBP containing EEE is imported than produced domestically the total amount of BBP coming into use annually within EEE would be some 2,000 t/y. Thus for the scenario-analysis it is assumed that 2,000 t/y of BBP are put on the market in the EU via EEE.

BBP quantity in

European EEE



3 HUMAN HEALTH

3.1 Human health hazard assessment

In the year 2007 an in-depth evaluation of potential risks of BBP to human and/or environment has been performed within the EU Risk assessment report series (details see ECB, 2007).

Following conclusions based on the hazard assessment have been drawn:

The acute toxicity of BBP in rodents is low. The oral LD50 ranged from 2.33 – 20.4 g/kg bw day in rats and were 4.17 g/kg bw/day and 6.16 g kg bw/day, for male and female mice, respectively. The outcome of toxicological studies re-vealed that the compound is not irritating to the skin and only slightly irritating to the eye. Data indicate that BBP does not possess sensitising potential.

Based on the present information BBP can be considered as a non-genotoxic

and non-carcinogenic substance.

Repeated dose toxicity studies with rodents indicate that BBP possess ad-verse effects on the liver and kidney. A NOAEL for oral exposure of 151 mg/kg bw and a NOAEL for the inhalative route of 218 mg/m3 have been deduced from a 13-week studies with laboratory rodents.

BBP is found to adversely affect the reproductive organs in rodents which may affect fertility. The developmental toxicity in offspring included prenatal mortality, reduced fetal weight, and malformed foetuses. Furthermore, the substance is found to be a developmental toxicant and to possess anti-androgen like proper-ties in experimental animal studies. The endpoints of concern are depicted in more detail in chapter 3.1.1.

3.1.1 Endpoints of concern

The present assessment takes into cognisance the previous the evaluation un-dertaken within the European risk assessment series (ECB, 2007).

Detail findings of individual studies are not discussed in the present report. In-stead, main findings of toxicological studies are depicted in Table 4.

The effect of BBP after repeated dose application to experimental animals has been investigated in several studies. Main target organs for BBP toxicity are the reproductive system, kidney and the liver.

Toxicological studies revealed that the most sensitive endpoints of BBPs toxicity profile are adverse effects on reproduction and development. In particular the male reproductive system has been identified as sensitive towards BBP.

The NOAEL of reproduction and developmental studies is in the range of 20 to 100 mg/kg bw.

For the endpoint fertility a NOAEL of 100 mg/kg bw/day has been deduced based on the study outcome of Nagao et al. (Nagoa et al., 2000). The NOAEL is based on adverse effects on fertility parameters, like atrophy of the testis, epidi-dymis, and seminal vesicle, and reduced reproductive organ weights have been observed in the F1 generation at 500 mg/kg bw/day.

Hazard assessment

in brief

Adverse effects on

reproduction and

developmental

system



For developmental effects a NOAEL of 50 mg/kg bw/day for the offspring based on adverse effects detected for anogenital distance (AGD) observed in the study of Tyl et al. (2004) has been deduced. The observed effect was dose-related in both F1 and F2 offspring.

Duty et al. (2003) evaluated in a human study the relation between semen qual-ity and exposure to phthalates. Altered semen quality parameters were associ-ated with high levels of mono butyl phthalate and/ mono benzyl phthalate in the urine. Due to co-exposure of various phthalates it is difficult to draw a conclu-sion that the altered semen quality was related only to BBP exposure.

An association between prenatal and postnatal exposure to phthalates and whether the exposure had any influence on reproductive organ development in newborn boys was studied in two epidemiological studies.

Results of an epidemiological study demonstrate an association between ma-ternal exposures to BBP as well as other phthalates and lower anogenital index (AGI) in boys (Swan et al., 2005). In another study only a marginal association was found between intake of milk contaminated with BBP and postnatal surge of reproductive hormones (SHBG, LH, testosterone and inhibin B) in new-born boys (Main et al., 2005).

A recent evaluation of epidemiological studies suggests that there is an asso-ciation between BBP childhood exposure and formation of asthma and eczema (Braun and Sathyanarayana, 2013).

BBP is in the EU EDS database listed as one of the 66 potentially endocrine substances with classification of high exposure concern (Annex 15)7. BBP has been classified as cat. 3 for wildlife, cat. 1 for Humans and Combined as cat. 1 (cat.1: Evidence for endocrine disruption in living organisms; cat. 2: Evidence of potential to cause endocrine disruption; cat.3: No evident scientific basis).

In vivo studies indicate that BBP possess an anti-androgen-like activity.

In a 13 week study with oral administration of BBP to Wistar rats in concentra-tions of 151, 381 and 960 mg/kg bw. a NOAEL of 151 mg/kg bw/day was de-rived. At the next dose level (381 mg/kg bw/day) adverse effects such as kidney weight increase, urinary pH decrease, histo-pathological changes in pancreas, gross pathological changes in the liver have been observed.

A NOAEL of 218 mg/m3 was derived from a 13 week inhalation study in Spra-gue-Dawley rats. At the applied dose of 789 mg/m3 adverse effects such as in-creased kidney and liver weight in male and female rats and a decrease in se-rum glucose in male rats have been detected.

7 List of 66 identified EDS substances with high, medium and low exposure concern:

http://ec.europa.eu/environment/archives/docum/pdf/bkh_annex_15.pdf

Evidences from

human studies

Endocrine

disruption

Repeated dose

toxicity

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Table 4: Examples of reproductive and repeated dose toxicity studies (cited in ECB, 2007)

Study type Species Application and exposure levels

Outcome LOAEL NOAEL Reference

Reproductive toxicity

Two generation study

Sprague-Dawley rats

Orally; by gavage

0, 20, 100 or 500 mg/kg bw/day

Atrophy of the testis, epidi-dymis, and seminal vesicle, and reduced reproductive organ weights in F1 genera-tion.

Increased serum follicle stimulation hormone (FSH) concentrations in F0 paren-tal.

- 100 mg/kg bw/day

(for effects on the re-productive organ).

20 mg/kg bw/day (al-tered hormone levels)

Nagao et al., 2000

Two generation study

Sprague-Dawley rats

Orally; in the diet

0, 50, 250, 750 mg/kg bw/day

Reduced anogenital dis-tance

250 mg/kg bw/day 50 mg/kg bw/day Tyl et al., 2004

Repeated dose toxicity

13 week study; re-peated dose toxicity study

Wistar rats Orally; in the diet

151, 381, 960 mg/kg bw/day

≥ 381 mg/kg bw/day in males:

Kidney weight increase, uri-nary pH decrease, histopa-thological changes in pan-creas, gross pathological changes in the liver

151 mg/kg bw/day in fe-males: Marginal increase in relative liver and cecum weight.

381 mg/kg bw/day 151 mg/kg bw/day Hammond et al., 1987

13 week repeated dose toxicity study

Sprague-Dawley rats

inhalative route

51, 218 and 789 mg/m3

Increased kidney and liver weight was reported at in male and female rats; a de-crease in serum glucose in male rats.

789 mg/m3 218 mg/m3 or 62.8 mg/kg bw/day

Monsanto (1982)



3.1.2 Existing Guidance values

An overview on derivation of national Occupational exposure limits (OELs) within the European member states as well as non member states is provided by the European Agency for Health and Safety at work (EU-OSHA website8). OELs and guideline values in different countries are between 0.5-5 mg/m3 (GESTIS9). No OEL for BBP has been derived by the European Scientific Committee on Occupational Exposure limits (SCOEL) so far10.

The tolerable daily intake (TDI), which is an estimate of the amount of a sub-stance in air, food or drinking water that can be taken in daily over a lifetime without appreciable health risk has been settled by the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) and is 0.5 mg/kg bw/day (EFSA, 2005). Likewise, as for the DNEL deri-vation the study of Tyl et al. (2004) and an assessment factor of 100 has been applied.

For the present assessment “Derived No Effect Levels” (DNELs), which have been critically deduced and reviewed within the European Risk assessment Committee in September 2013 (RAC, 2013) are going to be used for further risk characterisation. The outcome of the derivation of different DNELs is summa-rised in

Table 5.

The point of departure for the DNEL derivation of BBP has been derived from the study of Tyl et al. (2004), in which reduced anogenital distance has been observed. A NOAEL of 50 mg/kg/day was used as point of departure.

Assessment factors have been applied for inter- and intra-species difference. There are too many uncertainties to draw a conclusion whether humans are more, less or equal sensitive than rats, therefore default values for interspecies (default: 4x2.5) were used (RAC, 2013). Applying the overall assessment factor of 100 an oral DNEL of 0.5 mg/kg/day was derived by the RAC for the general population. The oral NOAEL rat was converted into a dermal corrected NOAEL by correct-ing for differences in absorption between routes (5% absorption is considered for the dermal route). Further correction for exposure during 5 days a week in-stead of 7 days a week has been applied to derive a dermal DNEL for workers. The oral NOAEL in rat (in mg/kg bw/day) was converted into an inhalatory cor-rected NOAEC (in mg/m3) by using a default respiratory volume for the rat cor-responding to the daily duration of human exposure (RAC, 2013). For the gen-eral population the exposure is considered to be 24 hrs/per day and for workers 8 hrs. Furthermore, for workers light work was considered for the estimation of the respiratory volume.

8 EU-OSHA: https://osha.europa.eu/en/topics/ds/oel/nomembers.stm 9 GESTIS-GefahrenSToffInformationsSystem – database of hazardous substances provided by In-

stitute for Occupational Safety and Health of the German Social Accident Insurance (IFA); http://limitvalue.ifa.dguv.de/Webform_gw.aspx

10 SCOEL: http://ec.europa.eu/social/main.jsp?catId=148&langId=en&intPageId=684

Occupational

exposure limits

Tolerable daily

intake

Derived no effect

level for BBP

Point of the

departure

Assessment factors

Oral DNEL

Dermal DNEL

DNEL inhalation



Table 5: Overview of the deduced derived no effect concentrations (DNELs) for BBP

(Source: RAC, 2013)11

Assessment Factors

Workers General population

(Adults& Children)

Interspecies, AF* 4 4

Interspecies, remaining differences 2,5 2,5

Intraspecies 5 10

Dose response 1 1

Quality of database 1 1

Applied Factor* 50 100

ORAL

Absorption (%) 100% 100%

NOAEL (not relevant) 50

DNELs ORAL in mg/kg/d (not relevant) 0.5

DERMAL


NOAEL (corrected) 1400 1000

DNELs DERMAL in mg/kg/d 28 10

INHALATION


Standard respiratory volume in m3/kg bw per day

0.38 1.15

LOAEC (corrected)1 123 43.5

DNECs INHALATION in mg/m3 9.9 1.7

*interspecies AF was not applied when calculation inhalation DNECs

11for details see:

http://echa.europa.eu/documents/10162/13579/rac_26_reference_dnels_bbp_en.pdf



4 ENVIRONMENT

An in-depth evaluation of BBP has been carried out in the frame of the Euro-pean risk assessment reports published in the year 2007 (ECB, 2007). Studies regarding the environmental fate properties of BBP and also adverse effects on environmental organism have been in detail reviewed and evaluated.

In the following section the environmental fate properties are and compared with the Persistence and Bio accumulative criteria (PBT criteria) settled down in Annex XIII of the REACH regulation, as well as with the criteria indicated in An-nex D of the Stockholm Convention (POPs criteria).

Predicted no effect concentrations (PNEC) which have been previously de-duced by within the EU RAR are depicted in chapter 4.2.3.

4.1 Environmental fate properties

There is evidence that BBP is readily biodegradable under aerobic conditions (fulfilling the 10 day window criterion). Under anaerobic conditions the bio-degration rate is slower (e.g., sediments or deeper soil or groundwater). Hy-drolysis and photolysis in water is likewise for other phthalates rather low.

There are two important steps in the metabolic pathway of aerobic or anaerobic biodegradation of phthalates, including BBP:

(1) the di-ester is hydrolysed into the mono-esters (monobutyl phthalate and monobenzyl phthalate) by esterases with low substrate specificity

(2) the mono-esters are converted into phthalic acid

Experimental data indicate a half-life for BBP in the atmosphere of app. 1.5 days. Studies indicate that primary biodegradation of BBP takes place, how-ever, with variable half-lives. Furthermore, data indicate that metabolites, mainly monoesters and phthalic acid, are formed. A comparison with the criteria de-termined in Annex XIII of the REACH regulation indicates that BBP does not ful-fill the P (Persistence) criteria.

The determined bio-concentration factors (BCFs) are in the range of 135-663 l/kg. For estimating the secondary poisoning the BCF value of 449 l/kg using 14C-labelled BBP was considered within the EU RAR, since this value covers the parent compound and also the mono-ester metabolites (MBuP and MBeP), which are supposed to have any impact on the organisms.

Biodegradation

Persistence

Bioaccumulation



Table 6: Summary of selected environmental parameters of BBP and comparison

with PBT and POPs criteria

Parameter Outcome PB criteria

(according REACH, Annex XIII)

POPs criteria (Stockholm Con-vention)

Surface water (river) (half-life)

0.5-3 ds 40 ds >60 ds

Log Kow 4.84 -- >5

Log Koc 10.5 l/kg -- --

Bio-concentration factor

135-663 l/kg >2000 l/kg >5000 l/kg

T Reprotoxic 1B substance meets the criteria for classification for CMR substances (categories 1A-1B)

toxicity or ecotoxicity data indicating po-tential to damage human health or

the environment

The present data indicate that BBP does not fulfil Persistence and/or Bioac-cumulation criteria stipulated in Annex XIII of the REACH regulation or criteria of Annex D of the International Stockholm Convention.

4.2 Environmental hazard

4.2.1 Eco-toxicity studies

To determine the possible adverse effects of BBP in the aquatic environment numerous short as well as long-term studies are available and summarised in the European Risk assessment report (ECB, 2007). A comparison of test results to that time revealed that the lowest NOAEC of 75 µg/l has been achieved from a 28-day study carried out with an invertebrate species (Mysidopis bahia), which has been considered as starting point for derivation of guidance values (“Predicted no effect concentration) within the EU RAR. However, within the EU RAR it was stated that further long-term toxicity data on fish should be available to determine possible endocrine effects in fish. A long-term fish study has been conducted in the year 2006-2008 and is published on the ECHA dissemination site. The data suggest four times higher sensitivity.

To determine the adverse effects on organisms in the aquatic sediments no ex-perimental data have been available, the equilibrium method has been used to estimate possible toxic effects and guidance values (ECB, 2007).

One acute toxicity earthworm test according to test guidelines has been per-formed to determine the possible adverse effects of BBP on the terrestrial

compartment. However, no LC50 could have been developed due to 100% sur-vival.

For the determination of toxic effects to the atmospheric compartment two separate phytotoxicity tests were carried out, in which no effects at the highest mean vapour concentration (5.7 µg/m3) have been detected.

Main conclusions on

ecotoxicity studies



4.2.2 Potential for secondary poisoning

Secondary poisoning is a phenomenon related to toxic effects which might oc-cur in higher members of the food chain resulting from ingestion of organisms from lower trophic levels that contain accumulated substances. Thus, chemicals which have bioaccumulation and biomagnification properties within the food chain may pose an additional threat.

An important factor to enter the food chain is the uptake of the substance by plants. Howver, data indicate that a more important route for phthalates con-tamination is the air-plant route, determined probably by the high log Kow and low valour pressure.

BBP has a Log Kow of 4.84 and measured BCF values in the range 135 – 663 l/kg. Therefore, an assessment of exposure through the food chain therefore becomes relevant.

Within the EU risk assessment series (ECB, 2007) a NOAEL of 50 mg/kg bw from a rat reproduction toxicity study (Tyl et al., 2004) is used for the derivation of the PNEC for prediators. Application of conversion factor of 20 and assess-ment factor of 30 a PNEC oral of 33 mg/kg in food has been deduced.

4.2.3 Existing guidance values (PNECs)

The predicted no effect concentration (PNEC) is the concentration below which exposure to a substance is not expected to cause adverse effects to species in the environment. Therefore the determination of these values is important for further characterisation of probable risks.

Based on the eco-toxicity studies PNECs (Predicted no effect concentrations) have been deduced (ECB, 2007).

Table 7 gives an overview of the PNECs for different compartments.

Table 7: Predicted no effect concentrations (PNECs) for different environment

compartments (Source: ECB, 2007)

Compartment NOAEL Safety factor PNEC

Aquatic Compartment

Surface water Marine

75 µg/l 75 µg/l

10 100

7.5 µg/l 0.75 µg/l

Freshwater-sediment* Marine-sediment*

--- --- 1.72 mg/kg wwt 0.17 mg/kg wwt

Soil* --- --- 1.39 mg/kg wwt

Secondary poisoning 50 mg/kg bw 30 conversion factor: 20

33 mg/kgfood (prediators)

*no experimental data available; PNEC derivation based on equilibrium partitioning method;



5 WASTE MANAGEMENT OF ELECTRICAL AND ELECTRONIC EQUIPMENT

5.1.1 WEEE categories containing BBP

According to DEPA (2010) no information on the use of BBP containing poly-mers, respectively PVC parts in individual EEE categories is available.

As explained in Chapter 2 BBP may be used in any type of EEE in applications such as synthetic leather and coated textile in straps, flexible or rigid PVC sheet, sealants, printing inks and adhesives.

5.1.2 Relevant waste materials/components containing BBP

Given the information on the use of BBP it is assumed that this amount, i.e. 2,000 t/a, will be contained in mixed “plastics” streams.

5.2 Waste treatment processes applied to WEEE containing BBP

5.2.1 Treatment processes applied

Initial treatment processes

Those WEEE which are separately collected, are either manually dismantled or shredded. These may be performed in large-scale ELV-shredders, in many cases combined with automated material sorting, or specific shredders (e.g. horizontal cross-flow shredders, plants for treatment of screens etc.).

In shredding processes BBP ends-up most probably in mixed plastics enriched fractions.

Given that BBP cannot be allocated to any easy to remove parts it is likely that also by dismantling BBP ends up also in an unspecific mixed fraction.

WEEE ending up in unsorted municipal waste is likely to be incinerated or land-filled. In MSW especially small appliances which are easily thrown into a waste bin are found.

A relevant share of the potential WEEE arising – be it as waste or as “used goods” - are supposed to be shipped to third countries. These WEEE may un-dergo dismantling, dumping or any kind of combustions process.

Main materials/

components

Treatment of

separately collected

WEEE

Treatment of WEEE

ending up in

unsorted MSW

Treatment of WEEE

exported



Subsequent treatment processes

Plastics containing fractions resulting from shredding of WEEE as well es from dismantling as the initial treatment are usually either:

� landfilled

� incinerated (incineration or co-incineration) in the form of mixed plastics en-riched fractions

For the production of solid recovered fuels required for co-incineration, PVC has to be removed to comply with limit values for Chlorine. Thus it is as-sumed that BBP is predominantly treated in waste incineration plants.

� or treated in further treatment processes for separation of materials, e.g. in so called post-shredder processes

Subsequent treatment of mixed plastics in third countries will be in many cases open burning or dumping.

5.2.2 BBP flows during treatment of WEEE

To evaluate which waste treatment processes are of relevance with regard to potential BBP released caused by WEEE and to estimate these releases the following scenario for the treatment of BBP containing WEEE was established.

It is assumed that the BBP-input into waste management by WEEE corre-sponds to the total quantity of BBP put on the European market via EEE12, i.e. 2,000 tonnes annually. Actual WEEE generation at a given time, e.g. based on models taking into account the life-time of particular equipment, was not con-sidered for the present assessment.

To estimate the flows of BBP entering individual treatment processes in particu-lar the following aspects were taken into account.

� the rate of separate collection of WEEE

� the rate of (illegal) shipment to third countries

� share of individual treatment processes applied to the relevant waste streams

The treatment scenario was established on the basis of European WEEE statis-tics (Eurostat, WEEE data for 2010), assumptions made by EC (2008b) and own estimations.

WEEE treated in WEEE treatment plants in the EU

44 %13 of the overall WEEE arising14 are treated in WEEE treatment plants in

the EU (i.e. 4.1 Mio t/a).

12 Based on 9.4 Mio EEE put on the market 2010 13 WEEE reported to be collected separately, including also 11% of WEEE (particularly large house-

hold appliances) not reported to be separately collected but treated by the same processes as the comparable appliances reported as being separately collected.

14 For the purpose of the present assessment the WEEE arising is seen equal to the amounts put on the market

Treatment of

shredder residues

Treatment of

plastics in third

Waste management

scenario for BBP

containing WEEE

Assumptions



Taking into account also the composition of WEEE that are reported to be sepa-rately collected (Eurostat, WEEE- statistics15) it is assumed that this amount is composed of:

� 61% (2.5 Mio t/a) large household appliances (assumption treatment: 80% shredder process; 20% manual dismantling)

� 7% (0.29 Mio t/a) small household appliances (assumption treatment: 100% shredder)

� 17% (0.7 Mio t/a) IT&T appliances incl screens (assumption treatment: 70% dismantling, 30% shredder)

� 15% (0.65 Mio t) thereof are consumer electronics incl. screens (assumption 30% dismantling, 70% shredder)

Thus for separately collected WEEE an overall share of 71% of shredding and a 29% of manual dismantling are assumed.

WEEE contained in unsorted MSW

13 % of the overall WEEE arising is not separately collected but ends up with unsorted MSW (i.e. 1.2 Mio t/a).

It is assumed that two thirds of MSW in the EU are landfilled, one third inciner-ated16.

WEEE shipped out of the EU

41 % of the overall WEEE arising (3.9 Mio t/a) are assumed to be shipped to third countries.

It is assumed that these are dumped or subjected to combustion.

Re-use of WEEE

A small share of an estimated 2% of WEEE being re-used is neglected within the present assessment.

Treatment of shredder residues

It is assumed that the total quantity of BBP entering WEEE shredder processes is transferred to shredder residues.

It is assumed that 2/3 of shredder residues resp. mixed plastics enriched frac-tions are landfilled and one third 1/3 is incinerated.

Treatment of mixed plastics fractions from manual dismantling

It is assumed that the total quantity of BBP entering WEEE dismantling is trans-ferred to any mixed fraction.

15 The shares of individual categories in the amounts reported tob e separately collected were used 16 See for example EEA (2013)



It is assumed that 2/3 of these fractions are landfilled and one third 1/3 is incin-erated. There is little indication that such mixed fractions are further separated for recycling of particular polymers.

Taking into consideration the material composition of WEEE and the estimates described in Chapter 2.3Fehler! Verweisquelle konnte nicht gefunden wer-

den. “Quantities of BBP used in EEE” an average BBP content of 0.021 % in WEEE is assumed.

Based on these assumptions the following BBP quantities entering the individu-al treatment processes were estimated (see Table 8 below).

Table 8: Estimated quantities of BBP entering the main treatment processes for WEEE and secondary wastes

derived thereof (in tonnes per year)

WEEE Secondary wastes

Separately collected

WEEE

WEEE in unsorted wastes

WEEE shipped out

of the EU

Mixed plastics derived from dismantling

Shredder residues

Secondary wastes from uncontrolled WEEE treat-ment in third

countries (incl. )

Re-Use 40

Manual dismantling 255

Shredding (and auto-mated sorting)

625

Landfilling (EU) 172 169 413

Incineration (EU) 86 84 206

Uncontrolled treat-ment in third countries (dismantling, dump-ing, burning)

820

5.2.3 Treatment processes selected for assessment under RoHS

In order to focus on those processes where risks for workers or the environment are most likely to be expected, the following process was selected as most rele-vant for the present risk assessment:

� Treatment of WEEE in shredders, because it is applied to BBP containing parts of WEEE at several stages in the overall treatment chain at a large number of installations/locations.

The following treatment processes were NOT selected for a quantitative risk de-termination within this assessment:

� Manual dismantling, because - as there is neither a mechanical nor a thermal treatment – releases to air, water and soil are considered to be low (Specific information on releases from / exposure through manual dismantling is not available).

� Landfilling, because WEEE and materials derived thereof are not the main source for BBP in the landfilled waste usually.

BBP input into

WEEE treatment

processes

Relevant processes

Less relevant

processes



� Incineration under controlled conditions, because WEEE and materials de-rived thereof are not the main source for BBP in the incinerated waste usual-ly. Furthermore a well functioning emission control is assumed.

� Treatment processes under uncontrolled conditions, because WEEE and ma-terials derived thereof are not the main source for BBP.

5.3 Releases from the relevant WEEE treatment processes

In the following information on and estimates of DEHP releases from the se-lected processes are summarized.

5.3.1 Shredding of WEEE

The most important route of BBP from shredding of WEEE or plastics materials thereof is considered to be via emissions of dust.

Emissions from shredders are typically abated by dust removal in a cyclone and a wet scrubber. According to the BREF WTI (2006) generic emission levels for dust (PM) associated to the use of BAT are in the range of 5-20 mg/Nm3. How-ever, treatment of metal wastes, including WEEE, in shredders has been in-cluded into the scope of IED-Directive recently. Information on the actual dust emissions from shredders under current operational conditions is scarce17.

From EC (2007) estimates of the quantities of diffuse emissions of dust are available. They estimate an overall annual release of PM10 from European car shredders of 2,100 tonnes resulting from manipulation of fluff and fines18.

In order to estimate BBP releases via diffuse emissions of dust during manipu-lating material streams at sites where WEEE are shredded, the following as-sumptions were made:

� The total input of BBP into WEEE shredders was estimated to account for 625 t/a (compare BBP flows in Table 8)

� 90% of the BBP input into a shredder are transferred to fluff/fines/dust19

� 0.1% of fluff/fines/dust are emitted diffusely via PM10 (under dry conditions, watering of the material and other measures for prevention of diffuse emis-sions will reduce the percentage by one order of magnitude)

The total quantity of BBP emissions via diffuse dust emissions from sites, where WEEE are shredded, is estimated to range from 56 kg/a

20 to for 562 kg/a21. The

actual order of magnitude will depend on the degree to which BAT for prevent-

17 Dust concentrations between 1.3 and 18.7 mg/Nm3 for German shredders have been reported

(BDSV, 2012) 18 based on an assumption of 18% generation of fines/dust from materials treated in a shredder and

an emission factor of the dry material (g/kg) of 1 g/kg 19 Assumption based on Morf et al. (2004) 20 RFair…0.09 g/kg 21 RFair…0.9 g/kg

Info on releases

Assumptions

concerning diffuse

emissions

Estimates of diffuse

emissions



ing diffuse emissions from handling of shredded materials including e.g. encap-sulation of aggregates or wettening of materials is applied.

Having in mind that not all shredders in the EU apply BAT, the estimation of BBP being emitted after de-dusting is based on the upper value for BAT-AELs, i.e. 20 mg/Nm3. Furthermore, an exhaust air flow of 20,000 m3/h22 and a treat-ment quantity of 60 t WEEE per hour23 were assumed.

Furthermore, it was assumed that the BBP concentration in dust is the same than in the processed EEE.

Based on these assumptions24 the BBP via residual dust emissions is estimated to account for 2.06 kg/a.

In order to estimate the BBP emissions per installation25

and day processing of WEEE in large-scale metal shredders was used as a reference. The following assumption was made:

� Typical daily WEEE throughput in a large-scale metal shredder is 250 tonnes26

Based on the resulting daily BBP input per installation of 53 kg and using the re-lease factors for BBP as illustrated above the following BBP releases per instal-lation and day are estimated:

� 4.7 to 47 g of BBP are emitted diffusely via particulates

� 0.17 g of BBP are emitted after de-dusting.

In general there is a tendency to further process mixed shredder residues with the aim to recover valuable metals and also to achieve legally binding recycling targets. In order to obtain recyclable metal-rich concentrates, several automated sorting techniques are used. These include also various types of mechanical treatments, such as shredding, milling, etc., where dust is generated. It is as-sumed that not all of those installations are equipped with efficient dust preven-tion techniques. Additional BBP releases via dust from processing of shredder residues in such installations are likely.

Emissions to water and soil from shredding are considered to be negligible.

Treatment of WEEE in large-scale metal shredders is a highly automated pro-cess, where workers primarily manipulate the material outdoors using various work machines, partly sitting in closed cabins.

22 E.g. described by Ortner (2012) 23 Umweltbundesamt (2008) 24 RFair = 0.0033 g/kg 25 According to EC (2007) there are 220 large scale shredders in the EU-25 26 Capacities of Austrian ELV-shredders: 25 – 60 t/h, assumption 7 working hours per day

Assumptions

concerning

channeled

emissions

Estimates

channelled

emissions

Releases per

installation and day

Further

considerations

Workplace

description

mechanical

treatment of WEEE

Vienna, October 2013

Figure 1: Large-scale metal shredder plant (Source: Umweltbundesamt, 2008)

Other mechanical processes where WEEE are treated cross flow shredders or special drums may be completedthe disintegrated appliances along a conveyer belt. The air at these indoor work places may be sucked or not. Usuallyprevention of dust inhalation, however, the practical implementation is consiered improvable.

Figure 2: Manual sorting of disintegrated WEEE (Source: Umweltbundesamt, 2008)

For the further mechanical treatment of mixed shredder residues different otions are realized. Installations exist where the gates are operated outdoors or partly encased. Thus material manipulation by workers is carried out outdoors or in ption.


shredder plant (Source: Umweltbundesamt, 2008)

cal processes where WEEE are treated including e.g. horizontal cross flow shredders or special drums may be completed by manual sorting of the disintegrated appliances along a conveyer belt. The air at these indoor work places may be sucked or not. Usually workers are required to use masks for prevention of dust inhalation, however, the practical implementation is consid-

Manual sorting of disintegrated WEEE (Source: Umweltbundesamt, 2008)

mechanical treatment of mixed shredder residues different op-tions are realized. Installations exist where the – mostly encapsulated – aggre-gates are operated outdoors or partly encased. Thus material manipulation by workers is carried out outdoors or in partly encased places with natural ventila-


25



Figure 3: Installation for further treatment of mixed shredder fractions (Source:

Umweltbundesamt, 2008)

Other installations have fully encapsulated grinding and sorting aggregates sit-uated in a closed building with indoor air extraction. The manipulation of the ma-terial is carried out both, indoors and outdoors.

5.3.2 Summary of releases from WEEE treatment

Table 9: Estimated total BBP releases from WEEE treatment processes in the EU (in

kg per year)

Air (particulates) dif-fuse

Air (particulates) channeled

Shredding (and automated sorting) of WEEE

56 - 562 2.06

Total 58 - 564

Table 10: Estimated local BBP releases from WEEE treatment processes in the EU (in

g per installation and day)

Air (particulates) dif-fuse

Air (particulates) channelled

Shredding (and automated sorting) of WEEE

4.7 - 47 0.17



6 EXPOSURE ESTIMATION

6.1 Human exposure

Humans are exposed to BBP via use of consumer products, indirect envi-ronmental exposure and/or due to occupational exposure. BBP has been found in air, water and soil and dietary products. Thus, human exposure can be through contaminated air, water, soil and food.

For the general population, the diet is considered as major source of BBP expo-sure. BBP in food might originate from the environment, food processing and/or food packaging.

The dietary daily intake of BBP has been estimated to be 0.0003 mg/kg bw/day for adults and 0.00083 mg/kg bw/day for children based on a total diet study (MAFF, 1996a, as cited in ECB, 2007, ECHA, 2008).

Additionally, the general population might be exposed through inhalation of in-door air due to the presence of BBP in PVC and non-PVC polymeric material. The maximal exposure concentration for the general population from intake of BBP from indoor air has been estimated to be 0.000083 mg/mg/kg bw/day (California Environmental Protection Agency, 1992, as cited in ECHA, 2008). For children there might be an additional exposure through intake of BBP from baby equipment and children toys (worst case: 0.00095 mg/kg bw/day) (ECHA, 2008).

6.1.1 Exposure estimates of workers of EEE waste processing plants Exposure estimates of workers of EEE waste proc-essing plants

The exposure estimation performed within this assessment is based on the as-sumptions and calculations provided in the chapter waste treatment and re-leases of BBP.

Within the frame of the process of registration of substances under REACH several guidance documents and supporting tools for exposure estimation have been introduced.

One of these tools, the TRA (Targeted Risk Assessment) tool has been estab-lished and developed by ECETOC to align with the expectations contained in Chapters R12-R16 of the Technical Guidance on Information Requirements and Chemicals Safety Assessment by ECHA and is frequently used by industry and also integrated in the Chesar tool, which is provided by ECHA.

Within this assessment the TRA tool 3.0. has been used to estimate exposure of workers.

Two scenarios have been selected as relevant regarding exposure due to waste management operations (see chapter 5.2.).

• shredding of WEEE containing BBP, where exposure mainly occurs through dermal uptake and inhalation of dust (see chapter 5.3)

General population

ECETOC TRA



One limitation of the TRA model is that waste treatment processes are not indi-cated explicitly by the uses and processes which can be selected, as the TRA tool is intended for industrial processes like manufacture or formulation.

Therefore the most appropriate processes to describe the exposure conditions of waste treatment processes have been chosen.

6.1.1.1 Exposure estimates: Shredding

As described above no process category for shredding is available. In order to select exposure conditions which are comparable with shredding- processes the process category 24: “high (mechanical) energy work-up of substances bound in materials and/or articles” has been selected. Further description of these pro-cesses is given in the REACH guidance document R.12: “substantial thermal or kinetic energy applied to substance by hot rolling/forming, grinding, mechanical cutting, drilling or sanding. Exposure is predominantly expected to be to dust” (ECHA, 2010).

No explanation on the differences of the subcategories 24 a, b, c is given in the R12 guidance nor in the ECETOC guidance (ECETOC, 2012); therefore all three subcategories have been selected.

Further selected input parameters: professional use of solid substance with high dustiness, 8 hours activity (>than 4 hours), outdoors, no respiratory protection or gloves (dermal PPE - personal protective equipment). Further 100% of sub-stance in the preparation (>25%) has been applied. The results were then cor-rected taking into account the calculated average BBP content of EEE (Chapter 2.3) and information on transfer of BBP to dusts from WEEE shredding (see Chapter 5.3.1). Thus the estimate of an average content of BBP in the dust of WEEE shredders is 0.021%. In table 9 the results of the assessment are summarized.

Table 11: Results of the ECETOC-TRA model for exposure and risk of shredding

Parameter PROC

Process

category

Long-term Inhalative Exposure Estimate (ppm for volatiles) / (µg/m3 for solids)

Long-term Inhalative Exposure Es-timate (µg/m3)

Long-term Dermal Ex-posure Esti-mate (µg/kg/day)

conc. solid 24a 2100 2100 2830

conc. solid 24b 3500 3500 2830

conc. solid 24c 14000 14000 2830

BBP 24a 0,44 0,44 0,59

BBP 24b 0,74 0,74 0,59

BBP 24c 2,94 2,94 0,59

DNEC/DNEL 9900 9900 28000

*RCR 24a 0,00004 0,00004 0,00004

*RCR 24b 0,00007 0,00007 0,00007

*RCR 24c 0,00030 0,00030 0,00030

*RCR: Risk Characterization Ratio

Limitations

RCR- Risk

Characterisation

Ratio



The comparison of exposure levels with hazard thresholds lead to the risk char-acterization. Dividing the exposure concentration by the derived hazard value (here: DNEC or DNEL) gives the risk characterization ratio (RCR): a RCR above 1 indicates a risk for human health for the mentioned concentration and route of exposure. By comparison of the derived exposure concentrations with the DNELs respectively DNECs derived by the RAC committee it can be seen that no risk is expected.

6.1.1.2 Monitoring of human exposure at EEE waste processing plants

Due to our knowledge there is no human bio-monitoring study investigating phthalate and/or phthalate metabolite concentrations in biological matrices of workers or neighbouring residents of WEEE plants.

6.2 Environment exposure

BBP might be released to the environment during its whole production and sub-sequent life-cyle, including its disposal. Their major releases into the environ-ment are the emissions into water and air (ECB, 2007).

To define background levels in industrial, urbanized and rural regions monitor-ing studies have been conducted. Monitoring data are summarised in the EU RAR (ECB, 2007). Higher exposure levels were detected in samples of urban and/or industrial areas.

Few monitoring studies have been carried out to determine the concentrations of BBP in the air. The BBP exposure concentrations are between 0.25 to 8 ng/m3. Higher values have been measured in areas of flooring and sealing plants (up to 403 ng/m3). The levels nearby these BBP sources varied depend-ing on factors such as sampling time, weather condition and facilities of the in-dustry (e.g., new installed “droplet” tap). Deposition of BBP in the air has been measured in studies carried out in Denmark. The observed deposition rate indi-cates that most of the BBP released to the air is deposited rather than de-graded.

Numerous studies have been conducted determining concentration levels of BBB in influents and effluents of sewage treatment plants. Lower exposure lev-els in the effluents indicate absorption of BBP to the sewage sludge. Effluents and waste water concentration of BBP from different diffuse sources (such as hospital, wash hall for technical equipment, kindergarden, paint and paintspray industries) are in the range of < 0.3-320 µg/l. Levels found in river and surface water are comparable low. Most of the samples show levels of BBP of less than 1 µg/l. Exemptions are samples taken from industrial sites.

BBP exposure level data in freshwater and marine sediment indicate higher levels of BBP in industrial areas. High concentration levels have been found in the samples taken from the Rhine (average concentration: 178 µg/kg wwt). Re-spresentative studies (27 different location) sides in the Netherlands showed levels of BBP in the of range of < 4-78 µg/kg dwt. Monitoring data indicate a widespread exposure of BBP to the environment.

Air samples

Aquatic

compartment

Freshwater and

marine sediment



BBP soil concentrations of studies reported in the EU RAR (ECB, 2007) are in the range of < 0.0001-0.4 mg/kg dwt. The highest concentrations (> 0.1 mg/kg dwt) are found close to BBP emitting sites and waste sites. Soil which was heavily contaminated sludge had BBP concentrations in the range of 0.007-0.051 mg/kg dwt.

Sludge from sewage treatment plants contained BBP concentrations in the range of < 0.14-1.4 mg/kg dwt.

Table 12: Summary of monitoring levels of BBP in different environmental compartments

(Source: ECB, 2007)

Compartment Concentration levels

Air

� without known BBP source � flooring plant � sealant plant

0.25-8 ng/m3

4 up to 403 ng/m3 1-38 ng/m3

deposition of BBP from air: � country site � urban site

11.2 µg/m2/year 45.9 µg/m2/year

Aquatic compartment

sewage treatment plant: � influents � effluent effluents from different industries waste water from different sources river/lake surface water

n.d – max. 560 µg/l n.d. – max. 34 µg/l < 0.3-106 µg/l 0.5 – 320 µg/l < 0.010-13.9 µg/l

Sediment

freshwater and marine sediment � without any known BBP source � industrial area

n.d.-78 µg/kg dwt up to 320 µg/kg wwt

Soil/sludge

soil sludge

< 0.0001-0.4 mg/kg dwt < 0.14-1.4 mg/kg dwt

1 exposure concentration vary depending on sampling conditions (e.g. time of sampling, weather

conditions, installation of new “droplet” tap)

6.2.1 Exposure estimates for the environment due to WEEE treatment

EUSES 2.0 has been designed to be a decision-support system for the evalua-tion of the risks of substances to man and the environment of new and existing substances and biocides. Within this assessment EUSES 2.1. was used to cal-culate predicted environmental concentrations, the so called “PECs” for the scenario shredding, which has been identified as most relevant.

In contrary to the ECETOC-TRA system described previously it is possible to select the scenario “waste treatment”. However, no applicable emission tables and no special scenario to be selected are integrated in EUSES so far, giving some limitations. However, the calculated releases (chapter 5.3) were used as input for local emissions. In order to ensure transparency are the selected input parameters summarized in Table 13.

Soil

EUSES

Limitations



Table 13: Selected EUSES input parameters

Descriptor input

Assessment mode Interactive

Assessment type Local scale

Additional: Predators exposed via the environment

Physical chemical properties Physical chemical parameters

Chemical class for Koc -QSAR Ester

Biodegradability readily-biodegradable

Industry category 4: Electrical/Electronic engineering industry

Use category 47: Softeners

Use pattern Waste treatment

Fraction of the main local source 0.02

Number of emission days per year 220

Table 14: Selected EUSES input parameters: shredding

Descriptor input

Production volume 625

Fraction of the EU production volume in the region 10

Fraction of tonnage released to air 1 (~100%)

Local emissions to air during episode 0.047 kg (max.)

Local STP input Bypass STP

Table 15: Results of environmental assessment using EUSES: shredding

BBP concentrations and PECs result unit

Concentration in air during emission episode 13.1 ng/m3

Annual average concentration in air, 100 m from point source 7.88 ng/m3

Local PEC in surface water during emission episode (dis-solved)

1.22 ng/l

Annual average local PEC in surface water (dissolved) 1.22 ng/l

Local PEC in fresh-water sediment during emission episode 47.5 ng/kg wwt

Local PEC in seawater during emission episode (dissolved) 0.243 ng/l

Annual average local PEC in seawater (dissolved) 0.243 ng/l

Local PEC in marine sediment during emission episode 9.48 ng/kg wwt

Local PEC in agric. soil (total) averaged over 30 days 55.8 ng/kg wwt

Local PEC in agric. soil (total) averaged over 180 days 55.8 ng/kg wwt

Local PEC in grassland (total) averaged over 180 days 63.3 ng/kg wwt

Local PEC in groundwater under agricultural soil 1.79 ng/l

EUSES Input

parameters



Table 16: Results of PECs for secondary poisoning: overall shredding

BBP concentrations and secondary poisoning result unit

Concentration in fish for secondary poisoning (freshwater) 2,19 ng/kg wwt

Concentration in fish for secondary poisoning (marine) 0,437 ng/kg wwt

Concentration in fish-eating marine top-predators 0,437 ng/kg wwt

Concentration in earthworms from agricultural soil 361 ng/kg

6.2.2 Monitoring data: WEEE treatment sites/locations

No monitoring data to determine BBP exposure levels are present in European countries near WEEE plants.

Only three monitoring studies measuring phthalate acid ester (PAE) levels in different environmental compartments have been carried out in China.

The monitoring studies indicate overall higher burden of phthalic acid esters (PAEs) of electronic waste recycling sites in China. Due to limitation of data presentation and that one study is only available in Chinese language, no exact BBP concentrations levels could be deviated from these studies.

Ma et al. (2012) has measured the total phthalic acid ester (PAE) (DEHP, DMP, DEP, DnBP, BBP, DnOP) in different environmental samples from an electronic waste recycling site in east China, in which the PAEs pollutants ranged from 0.31 – 2.39 mg/kg and 1.81-5.77 mg/kg in soil and plant samples, respectively.

Results indicate that PAEs concentration in soil samples are depended on the kind of vegetables (e.g., combination of carrot, soybean, cauliflower, radish and pak choi or alfalfa) cultivated on soil and indicate that PAEs are removed by plants in a different order of magnitude. Thus, highest concentration levels (2.39 mg/kg) of PAEs were found in fallow plots with no growing plants.

The measurement of PAEs in plant samples revealed high loadings. The con-centrations ranged from about 1.81-5.60 mg/kg dw. The results demonstrate that leafy vegetables have lower capacities to accumulate PAEs than root or stem vegetables. The highest concentration has been observed in edible parts of radish roots.

A further study carried out by Liu et al. (2010) determined phthalic acid esters (PAE) in soil samples from e-waste recycling cites in China. The total PAEs concentration found in the soil samples were even higher than those detected in the study of Ma et al. (2012) and were in the range of 12.5 to 46.6 mg/kg soil.

Total PAEs measured in particular matter in air samples are twice higher com-pared to urban areas as demonstrated in the study of Gu et al. (2010). Total phthalate concentrations were 216.41 ng/m3 at summertime and 326.6 ng/m3 at wintertime. Compared to 106.16 ng/m3 at summertime and 197.08 ng/m3 at reference site.



7 IMPACT AND RISK ESTIMATION

7.1 Impacts on WEEE management as specified by Article 6(1) a

Taking into account restrictions of BBP (e.g. according to REACH) it is assumed that recycling possibilities for BBP containing PVC may be reduced due to the presence of BBP in plastics derived from WEEE.

Under current operational conditions PVC is used for the production of low val-ue articles (shoe soles, hoses etc.). Thus it is not assumed that BBP would stay in the recycling loop for many cycles. A closed loop recycling of PVC from ca-bles and wires is technically not possible due to metal contaminations.

Wastes with a BBP content of 0.5% are considered hazardous in accordance to the European list of waste (fulfillment of criterion H10, reprotoxic27

).

As information on amounts of BBP actually contained in particular material streams resulting from the treatment of WEEE no estimation can be drawn on the degree of prevention of hazardous wastes due to restriction of BBP in EEE.

7.2 Risks estimation for workers and neighbouring residents

Shredding of WEEE has been identified as most relevant treatment procedure regarding BBP exposure. Exposure estimates using the ECETOC TRA model show that under the assumptions taken no risk for workers from shredder plants are expected.

From third countries phthalic ester pollution has been reported leading to con-tamination of food stuff and it is to be expected that workers and neighbouring residents of WEEE treatment sites are exposed to considerable levels of BBP and other toxic phthalates. There is cause of concern due to reprotoxicity and endocrine disrupting effects for neighbouring residents. Furthermore it can be expected that there is a risk for workers and neighbouring residents due to un-controlled combustion. Symptoms from vapours from very hot material are eye irritation, headache, drowsiness, and convulsions. Long term effects due to ex-posure to hazardous incineration products can be expected.

7.3 Risks estimation for the environment

In order to assess if the BBP exposure of the herein described scenarios pose a risk to the environment the PECs have been compared with the corresponding PNECs. In general if the ratio of the predicted environmental concentration to the concentration which is expected to pose no risk is higher than 1 a risk can be expected and risk reduction measures should take place. In table 17 the PECs and PNECs are depicted.

27 According to 2000/532/EC one or more substances toxic for reproduction of category 1 or 2 clas-

sified as R60, R61 at a total concentration ≥ 0,5 % mean that H10 is fulfilled

BBP remaining in

the recycling loop

Generation of

hazardous waste



Table 17: comparison of PNECs with estimated PECs

Compartment PNEC PEC

surface water 7.5 µg/l 1.22 ng/l

freshwater sediment 1.72mg/kg 47.5 ng/l

soil 1.39 mg/kg 55.8ng/l

fish freshwater mg/kg 33 mg/kg 2.19 ng/m

birds (mg/kg) 33 mg/kg 0.437 ng/kg

Mammalian 33 mg/kg 361 ng/kg

According to the estimated exposure conditions based on the EUSES model for waste treatment, with specific input data for local emissions there is no risk for the environment for BBP from shredder plants expected. Concentrations are in the nanogramm scale whereas PNECs, derived from the RAR lay in the micro-gram scale. The estimation of predicted environmental concentrations derived within this assessment has certain limitations, monitoring data would be advan-tageous.

PECs



8 ALTERNATIVES

8.1 Availability of alternatives

Recently, several phthalate alternative assessments have been conducted summarizing potential alternatives and its possible hazardous adverse effects, as well as its technical properties in order to determine feasible substitutes. Be-side other supposed less hazardous phthalate compounds, non-phthalate alter-natives (e.g., Di-isononyl-cyclo-hexane-1,2dicarboxylate – DINCH; Alkylsul-phonic phenylester - ASE), other petroleum based materials and bio-based plastics (for details see Lowell Center, 2011; Maag et al., 2010, DEPA; 2011, COWI, 2009) are summarized. However, still there is lack of data for some al-ternatives regarding specific aspects of hazardous potential to human health and environment.

The outcome of alternative assessment for application of BBP in EEEs carried out by DEPA (2010) re-vealed that: “The use of BBP in EEE is not deemed es-sential as technically suitable alternatives are available and already used today for similar applications as the possible applications in EEE, however for some specific non-polymer applications substitution may be particular difficult” (DEPA, 2010).

The use of BBP has strongly declined within the last decades, indicating that suitable and technically feasible alternatives are present and already applied (COWI, 2009).

The principal alternatives to BBP appear to be di-benzoates such as dipropyl-ene glycol dibenzoate (DGD) and the mixed di-benzoates product Benzoflex 2088, which have been increasingly used in the vinyl flooring business (the main application of BBP) (DEPA, 2010).

Furthermore, glycerol triacetate (GTA) may also be a technically suitable alter-native, especially for non-polymer applications. Alkyl-sulfonic phenylester (ASE) as primary plasticiser used instead of BBP may reduce the need for adding a gelling aid like BBP. ASE is however currently somewhat more expensive than BBP.

There might be further other alternatives to BBP, such as the from a toxici-cological view point very suitable substitute Di-isononyl-cyclohexane-1,2dicarboxylate (DINCH) (for details see COWI, 2009).

8.2 Hazardous properties of alternatives

In the following some key characteristics for some selected possible alternatives used in EEE applications are summarised (for further details on alternatives see COWI, 2009).

Dipropylene glycol di-benzoate (DGD) has been reviewed within the alterna-tive assessment carried out by COWI in the year 2009 (COWI, 2009). The as-sessment of the hazardous properties is based on the information from manu-facturers of Benzoflex ® 9-88 containing up to 100% DGD. Benzoflex ® 9-88 has low acute toxicity potential. Also the data of the repeated dose toxicity stud-ies indicate a low toxic potential (deduced NOAEL 1000 mg/kg bw/day based

Alternative

assessments

BBP in EEE

Examples of

alternatives



on decreased body weight, effects on liver, spleen, caecum). Data of two-generation studies suggest a NOAEL of 500 mg/kg bw/day.

Based on the currently available data a low toxic potential of DGD can be as-sumed, which indicates that DGD is a suitable alternative for BBP.

Glyceryl triacetate (GTA) possess a low acute toxicity and the NOAEL (oral) for repeated dose toxicity is 1000 mg/kg bw/day. The outcome of combined re-peat dose and reproductive/developmental toxicity screening test in rats re-vealed no adverse effects on reproductive parameters, or maternal or foetal tox-icity to concentrations up to 1000 mg/kg bw/day. Data on glyceroyl triacetate toxicity studies suggest low toxic potential.

Alkylsulphonic phenylester (ASE): Data of the developmental toxicity study did not indicate any adverse effects up to doses of 530 mg/kg bw. However, the study dates back to 1956 and lacks good reporting. Therefore a clear conclu-sion might not be drawn. ASE possess low acute toxicity and no irritating, sensi-tising or mutagenic potential has been identified (DEPA, 2011). Based on the evaluation of COWI (2009) the most critical endpoint is the liver toxicity LOAEL 55.4 mg/kg bw/day.

Di-isononyl-cyclohexane-1,2-dicarboxylate (DINCH) has not shown any ad-verse effects in reprotoxicity studies in concentrations up to 1000 mg/kg bw/day (animal species: rat and rabbits). The most critical endpoint of DINCH has been observed to be kidney with a LOAEL of 107.1 mg/kg bw/ day (COWI, 2009).



Table 18: Summary of most relevant concerns for identified alternatives, which might be used in the EEE sector (for

details see COWI, 2009)

Substance Name CAS Number Human health concerns Environmental health concerns

Harmonised (HC) and/or self-classification (SC)*

Dipropylene glycol dibenzoate (DGD)

27138-31-4 Data indicate low acute toxicity. NOAEL of 1000 mg/kg bw/day observed in repeated dose toxicity studies indicate low re-peated dose toxicity.

Data do not allow to draw firm conclusion on biodegradable pro-perties. DGD possess moderately bioaccumu-lative properties. Ecotoxicity data indi-cates toxic effects to aquatic organism.

no HC; SC: Aquatic Chronic 2; Aquatic Chronic 3; Eye Irrit. 2; Repr. 2

Glycerol triacetate (GTA)

102-76-1 Data indicate low acute toxicity with LD50 values above 2000 mg/kg bw. No maternal or fetal toxicity or adverse effects on repro-duction have been ob-served in combined re-peat dose and reproduc-tive/developmental toxicity studies.

Substance is readily biodegradable and pos-sesses low bioaccumu-lation potential. Fur-thermore toxic effect seen in studies with bi-ota is low.

no HC; SC: Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1

Alkylsulphonic phenylester (ASE)

91082-17-6 Has not comprehensively studied for toxic effects.

Not readily bio-degradable and poten-tial for bioaccumulation Data on aquatic organ-ism indicate low toxicity.

no HC; SC: aquatic chronic 4

Di-isononyl-cyclohexane-1,2dicarboxylate (DINCH)

166412-78-8 No effects on fertility or development have been observed in doses up to 1000 mg/kg bw/day(rat)

Not readily bio-degradable. Data indi-cate moderate bioac-cumulation potential.

no HC; no SC

* indicated in the Classification and Labelling (C&L) inventory from ECHA (available at:

http://echa.europa.eu/web/guest/information-on-chemicals/cl-inventory-database)

8.3 Conclusion on alternatives

Detailed assessments on possible alternatives have been carried out previously (Maag et al.; 2010, COWI; 2009, DEPA; 2010). Beside the hazard profile also the use and technical feasibility of possible substitutes has been determined.

Based on these assessments, it can be concluded that the use of less harmful alternatives to the hazardous BBP is possible and already in place. The use of BBP in EEE is not deemed essential, however, some niche application cannot be ruled out.



9 SOCIO-ECONOMIC IMPACT ANALYSIS

9.1 Approach and assumptions

The socio-economic analysis is based on two scenarios:

� In Scenario A the present legislation is not changed and BBP may continue to be used in electrical/electronic equipment (no ban of BBP).

� In Scenario B the use of BBP in EEE is banned. For the purpose of the socio-economic analysis BBP is replaced in PVC (and other plastics) by the plasti-ciser GTA (Glycerol triacetate). While GTA may not be the most appropriate alternative in all cases, it at least can replace BBP in some applications and serve here as a basis for estimating the orders of magnitude of the costs of replacing BBP in EEE by an available non-phthalate-substitute.

The data used in this socio-economic analysis have been mainly presented by DEPA (2010).

Some of the assumptions used in the socio-economic analysis are valid for both scenarios and thus for the frame assumptions of this analysis. Following as-sumptions are taken:

1) The selection of BBP or of GTA as its alternative does not have an effect on the life time of the EEE or its usability.

2) DEPA (2010) estimates the amount of BBP used in EEE produced within the EU to be 20 to 200 tonnes per year. When assuming that ten times as much of BBP containing EEE is imported than produced domestically the total amount of BBP coming into use annually within EEE would be some 2,000 t/y. Thus for the scenario-analysis it is assumed that 2,000 t/y of BBP are put on the market in the EU as part of EEE.

Table 19 summarises the described frame assumptions.

Table 19: Frame assumptions of the Socio Economic Analysis regarding a ban of BBP

as plasticiser of plastics used in EEE (electrical and electronic equipment)

Parameter Assumption

Effect on life time of EEE Negligible effect

Consumption of plasticiser in t/y 2,000

In the following the impact of Scenario B (ban of BBP) is compared to Scenario A (no ban of BBP) from the point of view of the different stakeholders along the life cycle before summing up the difference of the 2 scenarios’ socio-economic impacts.



9.2 Impact on producers of plasticisers and plastics

The BBP substitution costs will mainly fall at the processors and formulators of PVC and other potentially BBP containing materials such as sealants or glues. For coatings and other integrated parts, the EEE manufacturers may act as PVC processors themselves, and may need to be involved in reformulation of the PVC plastisols (suspension of PVC particles in a plasticiser) or compounds used. The plasticiser producers will normally be involved in the substitution, be-cause they act as advisors for the processors and formulators in the formulation of the polymer/plasticiser system. The alternative plasticisers are already devel-oped and marketed, but costs for increasing the production volume may be im-plied. One of the alternatives to using BBP is to simply omit its use. This may result in increased production time and thereby potentially increased production prices. All substitution costs are expected to ultimately be furthered to the end customers. (DEPA 2010).

Both BBP and GTA are examples of plasticisers produced by relatively large/multinational European based companies.

Production of EEE is substantial in the EU. However, a large part of the total end-user consumption of EEE is imported as finished goods from outside the EU. This is notably the case for small household appliances, consumer elec-tronics, IT equipment, and toys etc., but also for other EEE groups.

For EU based EEE producers, BBP containing parts may be produced by them-selves or by subcontracting PVC processing or non-polymer formulator compa-nies in the EU as well as on the world market.

More than 400 manufacturers in the EU produce plasticised PVC products/parts of types, which may be of relevance for EEE. It is, however, not known how many of these actually produce EEE parts and how many are small or medium sized enterprises (SMEs).

For most applications of BBP a one-to-one replacement of BBP with GTA or plasticisers cheaper than GTA will be possible. It is not expected that small and medium sized enterprises (SMEs) will be affected more than the general indus-try in the sectors in question with respect to the technical compliance. The plas-ticiser companies offering the alternatives are large companies, and they serve as general customer advisers when it comes to adjusting polymer formulations and production setup.

Previous studies have clearly indicated that SMEs are affected to a greater de-gree by compliance with the RoHS legislation compared to their larger competi-tors, mainly due to the additional administrative burden (DEPA 2010).

DEPA (2010) estimates that the material price of BBP is about 1 €/kg. The price of GTA is 1.5 €/kg (DEPA 2010), so that by a BBP ban additional material costs of 0.5 €/kg of plasticiser would occur. In addition DEPA (2010) estimates in-vestment costs to be small. As no number is given by DEPA (2010) for the in-vestment costs when switching from BBP to an alternative, it is assumed that the same material cost to investment cost ratio applies as with the substitution of HBCDD that is 85 to 15. This results in investment costs 0f 0.09 €/kg of re-placed BBP.



In sum the material and investment costs for replacing 1 kg of BBP by GTA are estimated to be 0.59 €. For the 2,000 tonne of BBP at a maximum to be re-placed in European EEE this gives 1.2 million € per year in additional material and investment costs.

With respect to jobs it is expected that the higher turnover of the plasticiser and plastic industry in Scenario B will create some additional jobs in this sector.

In scenario B (ban of BBP) the health impact on the workers of the plasticiser and plastics industry are expected to recede, in the EU but also abroad.

9.3 Impact on EEE producers

Production of EEE is substantial in the EU. However, a large part of the total end-user consumption of EEE is imported as finished goods from outside the EU. This is notably the case for small household appliances, consumer elec-tronics, IT equipment, and toys etc., but also for other EEE groups.

As the service of the plastic used in EEE does not change when switching from BBP as plasticiser to GTA, for example, no major effect is expected for the EEE producers. Only when they are also plastic producers, they are affected as de-scribed above.

For most EEE, the parts which may contain BBP comprise only a minor fraction of the equipment/product and thus also only a minor part of the total production price of the product. If used at all for this equipment, BBP and alternatives are only used in small concentrations, further decreasing importance of the secon-dary plasticisers' price in this context. Also, considerable fractions of the flexible PVC and other materials used in EEE may already be formulated with other specialty plasticisers instead of BBP. Increases in consumer prices for EEE as a result of a restriction of BBP use in EEE are therefore expected to be minimal or even negligible.

As compared to the turnover of the EU electrical engineering industry of 411 bil-lion € in 2008, the additional (worst case) costs of 1.4 million € (+0.0003 %) is so small that no influence on the market needs to be feared.

9.4 Impact on EEE users

Increases in consumer prices for EEE as a result of a restriction of BBP use in EEE and thus any negative effects on consumers are expected to be minimal or even negligible.

The main consumer benefit lies in the lower health risk of alternative plasticis-ers.



9.5 Impact on waste management

As BBP is to a large extent used in smaller parts, their treatment when disposed off will follow the EEE products they are parts of, and a change in plasticiser will likely not in itself form the basis of changes in the solid waste handling scheme for EEE. No changes in solid waste handling costs are expected as a conse-quence of prohibiting the use of BBP in EEE (DEPA 2010).

9.6 Impact on administration

According to DEPA (2010) extra compliance costs are related to the addition of one new substance under RoHS are expected to be minimal for companies which have already implemented RoHS, that is, most relevant companies.

The main extra costs are estimated to be related to control; both by the manu-facturers / importers and the authorities. The presence of BBP cannot be de-termined by simple XRF screening, therefore sampling, extraction and labora-tory analysis (gas chromatography followed by mass spectroscopy) is required.

The additional costs of a BBP analysis of in flexible PVC in addition to a BBP analysis in Denmark is reported to be about 30 € (DEPA 2010).

For non-polymers parts like adhesives and paints, it may be necessary to take extra samples – if possible at all – in order to analyse for the presence of BBP (and eventually other regulated phthalates). There is at the moment no simple “rule-of-thump” telling where the substances could most likely be found and they are probably present at a very low frequency (DEPA 2010).

The administrative costs for Scenario B (ban of BBP) are estimated as follows:

� Assuming that BBP will be banned, too, and that BBP-freeness needs to be tested as frequently as BBP-freeness, DEPA (2010) estimates that the addi-tional costs for proving that the produced plastics is BBP free is 30 €.

� When assuming that for the EU as a whole 7,000 test per year (that is 250 tests per EU Member State and year) are sufficient to control a BBP ban, the costs for the EU as a whole would be 210,000 € annually.

The administrative costs, however, are not lost costs, as they increase the turn-over of the EU chemical analysis industry.

9.7 Total socio-economic impact

It is not clear if BBP is used at all in EEE in Europe. Therefore this socio-economic analysis is kind of a “worst-case” analysis, showing the costs of re-placing BBP, if substantial amounts of BBP happen to be used in European EEE.

The total economic costs of a BBP ban and replacement by GTA (Scenario B) are estimated to lie with 1.4 million € annually (see Table 20).



The total effect on jobs is expected to be very small. While few jobs may be lost in the industries using EEE (caused by the marginally increased prices of EEE), some jobs are created with producers of the alternative plasticisers and the en-vironmental (chemical analysis) industry.

With respect to the benefits, however, the impact of the BBP ban may be big (as compared to a scenario in which considerable amounts of BBP are still used in EEE):

� Increase in the competitive position of environmentally friendly industry

� Globally reduced environmental and health impacts during BBP and plastics production

� Reduced environmental and health impacts during use and especially during the waste and recycling phase.

In total the ban of BBP creates limited additional costs while creating additional benefits for health, environment and economy.

Table 20: Scenario Management Tableau of the Socio Economic Analysis regarding a ban of BBP as plasticiser for

materials in EEE (electrical and electronic equipment)

Scenario A – no ban of BBP

Scenario B –

ban of BBP

Plasticiser used in EEE plastics BBP GTA

Additional raw material costs of plasticiser in €/kg 0 0.5

Additional investment costs for changing to other plas-ticiser in €/kg

0 0.09

Additional raw material + investment costs for BBP or its alternative in €/kg

0 0.59

Additional raw material + investment costs for BBP or its alternative in €/y

0 1,200,000

Additional costs for EEE producer in €/y 0 0

Additional costs for waste treatment in €/y 0 0

Additional administrative costs in €/a 210,000

Total additional costs for final consumers 0 1,410,000

Benefits Increase in the competitive position of environmentally friendly industry

Reduced environmental and health impacts during plasticiser and plas-tics production in the EU and abroad

Reduced environmental and health impacts during the use and espe-cially the waste phase

1 As the ban becomes effective only gradually due to an adequate transition period and as plastics containing BBP will stay in the

system due to the lifetime of the products and plastics recycling, the benefits for environment and health during the use and waste

phase will materialise only gradually.



10 RATIONALE FOR INCLUSION OF THE SUBSTANCE IN ANNEX II OF ROHS

Hazardous potential

Nature and reversibility of the adverse effect

BBP is a substance of very high concern due to effects on fertility, reproductive organs, development and endocrine activity. Furthermore, the substance is found to be a developmental toxicant. Effects reported in the studies included a decreased anogenital distance, increases in male offspring with reproductive tract malformations, as well as effects on testicular migration.

BBP releases from WEEE treatment

The bigger part of environmental releases of BBP from relevant WEEE treat-ment processes28 are releases to the air. The total annual releases are esti-mated to account for 0.06 – 0.56 tonnes.

COWI (2009) provides a summary of total releases of BBP during the individual use phases (see Table 21):

BBP releases from handling of materials at sites where WEEE are shredded were found to be a major source of emissions to air from waste treatment op-erations. The calculated releases (0.06 to 0.56 t/a) are higher than releases to air by other disposal operations (0.02 t/a), even in a scenario where sufficient measures for prevention of dust emissions are taken (0.06 t/a).

Taking into account that material streams derived from WEEE may be sub-jected to mechanical treatment processes several times during the overall treatment chain, the actual releases are expected to be even higher.

Furthermore, additional amounts of BBP are expected to be emitted from land-fills (predominantly to waste water), incineration plants (predominantly to air) and uncontrolled treatments caused by WEEE.

Compared to the overall releases of BBP to air (50 t/a) releases resulting from handling of materials at sites where WEEE are shredded are low.

28 i.e. treatment of WEEE in shredders

Substance of very

high concern

WEEE treatment

compared to other

waste treatment

processes

Releases from

WEEE treatment

compared to total

BBP releases



Table 21: Total releases of BBP (Source: COWI, 2009, Table 0-1)

Exposure of workers

Under the assumptions taken within this assessment the exposure to BBP of workers at sites where WEEE are shredded in the EU is low; however monitor-ing data are missing. Up to about 7,000 workers are potentially exposed within the European Union.

Based on an estimated number of 450 installations in the EU where WEEE and materials derived thereof are treated mechanically and assuming 5 to 15 work-ers per installation29, the estimated number of workers exposed to BBP ranges between 2,250 to 6,750.

Risk for human health

Under the assumptions taken within this assessment it is expected that there is no risk for human health of workers at WEEE shredding plants due to BBP ex-posure.

In third countries, due to unsafe working conditions a risk from BBP exposure is expected. Also neighboring residents are presumable exposed and at risk.

The assessment of endocrine disruptors in the regulatory context in the Euro-pean Union is currently under discussion. As it is not possible to establish a threshold for adverse effects of genotoxic carcinogens it is under debate if this is possible for endocrine disrupters. Taking this into consideration release and exposure towards endocrine disrupters such as BBP should be minimized.

Exposure of the environment

Under the assumptions taken within this assessment the exposure of the envi-ronment to BBP due to handling of WEEE-materials at shredder plants is low; however monitoring data are missing.

Risk for the environment

Under the assumptions taken within this assessment it is expected that there is no risk for the environment due to BBP exposure.

29 Estimation based on Umweltbundesamt (2008)



Main influencing factors within the risk assessment

Regarding the establishment of the waste management scenario and determi-nation of environmental releases there are 2 major factors:

� The annual quantities of BBP actually contained in the collected WEEE are influenced by various factors, including the actual BBP put on the European market via EEE, the lifespan of EEE, the actual WEEE collection.

� The degree of applying measures for preventing diffuse emissions when handling materials derived from shredded WEEE affects the estimated BBP releases considerably. However, there is no information available on the ac-tual implementation of such measures.

The environmental exposure estimation is based on EUSES, which does not address waste treatment specifically yet. Thus, appropriate scenarios were de-fined, emissions and releases calculated and then used as input parameters.

Impact on waste management

The extent to which material recycling/recovery is affected:

Taking into account restrictions of BBP (e.g. according to REACH) it is expected that recycling possibilities for plastics containing BBP will be reduced due to the presence of BBP in plastics derived from WEEE.

The extent to which BBP remains in the recycling loop

Under current operational conditions PVC is used for the production of low val-ue articles (shoe soles, hoses etc.). Thus it is not expected that BBP contained in PVC stays in the recycling loop for many cycles. A closed loop recycling of PVC from cables and wires is technically not possible due to metal contamina-tions.

The amount of hazardous waste which is generated in the course of

processing WEEE

Wastes with a BBP content of 0.5% are considered hazardous in accordance to the European list of waste.

As information on amounts of BBP actually contained in particular material streams resulting from the treatment of WEEE no estimation can be drawn on the degree of prevention of hazardous wastes due to a potential restriction of BBP in EEE.

Available Alternatives

Detailed assessments on possible alternatives were carried out recently (Maag et al.; 2010, COWI; 2009, ECHA; 2013, DEPA, 2010). Beside the hazard profile also the use and technical feasibility of possible substitutes were determined. The mentioned pieces of work come to the conclusion that substitution of BBP by less harmful substances (e.g. GTA) is possible and already in place. The use of BBP in EEE is not deemed essential, however, some niche application can-not be ruled out.



Socio-economic impact analysis

In total the ban of BBP in EEE would create limited additional costs (1.4 million € annually) while creating additional benefits for health, environment and econ-omy.

The total effect on jobs is expected to be very small. While few jobs may be lost in the industries using EEE (caused by the marginally increased prices of EEE), some jobs are created with producers of the alternative plasticisers and the en-vironmental (chemical analysis) industry.

With respect to the benefits, however, the impact of the BBP ban may be big (as compared to a scenario in which considerable amounts of BBP are still used in EEE):

� Increase in the competitive position of environmentally friendly industry

� Globally reduced environmental and health impacts during BBP and plastics production

� Reduced environmental and health impacts during use and especially during the waste and recycling phase.

As it is not clear, if BBP is used in EEE in Europe at all the socio-economic analysis can be seen as a kind of a “worst-case” analysis, showing the costs of replacing BBP, if substantial amounts of BBP happen to be used in European EEE.

Draft Conclusion:

It is recommended to include BBP in Annex II to the RoHS-Directive because:

� a risk for workers and neighboring residents in third countries is ex-pected

� a risk for the environment in third countries is expected

� BBP releases to air from sites where WEEE are shredded are higher com-pared to BBP releases from any other disposal operation

� alternatives with less negative properties are available and technically and economically feasible (e.g. GTA)

� the socio-economic analysis revealed limited additional costs but considera-ble additional benefits when restricting BBP in EEE.

For the maximum concentration of BBP per homogenous material to be tolerated in EEE a value of 0.1 weight % is proposed.



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www.plasticseurope.de/cust/documentrequest.aspx?DocID=46028



12 ABBREVIATIONS

ASE ................... Alkylsulphonic phenylester

BBP .................... Benzyl Butyl Phthalate

CAS .................... Chemical Abstract Service

CMR ................... Carcinogenic, Mutagenic and toxic to Reproduction

BBP .................... Bis (2-ethylhexyl) phthalate

DEHP ................ Bis(2-ethylhexyl)phthalat

BBP .................... Dibutyl phthalate

DGD ................... Dipropylene glycol dibenzoate

DINCH ................ Di-isononyl-cyclo-hexane-1,2dicarboxylate

EEE .................... Electrical and electronic equipment

GTA .................... Glycerol triacetate

PBT .................... Persistent, bio accumulative, toxic

PVC .................... Polyvinyl chloride

RAR ................... Risk assessment report

REACH .............. Registration, Evaluation, Authorisation and Restriction of Chemical

Substances

RoHS ................. Restriction of hazardous substances

SVHC ................. Substance of Very High Concern

vPvB ................... Very persistent and very bioaccumulative

WEEE ................ Waste of electrical and electronic equipment

WPP ................... Waste processing plant



13 LIST OF TABLES

Table 1: Substance identity and composition (Source: ECHA, 2008) ............. 5

Table 2: Physico-chemical properties of BBP (Source: ECHA, 2008) ............. 6

Table 3: Harmonised classification of BBP1 ..................................................... 7

Table 4: Examples of reproductive and repeated dose toxicity studies (cited in ECB, 2007) ......................................................................... 13

Table 5: Overview of the deduced derived no effect concentrations (DNELs) for BBP (Source: RAC, 2013) ........................................... 15

Table 6: Summary of selected environmental parameters of BBP and comparison with PBT and POPs criteria .......................................... 17

Table 7: Predicted no effect concentrations (PNECs) for different environment compartments (Source: ECB, 2007) ........................... 18

Table 8: Estimated quantities of BBP entering the main treatment processes for WEEE and secondary wastes derived thereof (in tonnes per year) ............................................................................... 22

Table 9: Estimated total BBP releases from WEEE treatment processes in the EU (in kg per year) ................................................................. 26

Table 10: Estimated local BBP releases from WEEE treatment processes in the EU (in g per installation and day) ........................................... 26

Table 11: Results of the ECETOC-TRA model for exposure and risk of shredding ......................................................................................... 28

Table 12: Summary of monitoring levels of BBP in different environmental compartments (Source: ECB, 2007) ................................................ 30

Table 13: Selected EUSES input parameters .................................................. 31

Table 14: Selected EUSES input parameters: shredding ................................ 31

Table 15: Results of environmental assessment using EUSES: shredding .... 31

Table 16: Results of PECs for secondary poisoning: overall shredding .......... 32

Table 17: comparison of PNECs with estimated PECs ................................... 34

Table 17: Summary of most relevant concerns for identified alternatives, which might be used in the EEE sector (for details see COWI, 2009) ................................................................................................ 37

Table 18: Frame assumptions of the Socio Economic Analysis regarding a ban of BBP as plasticiser of plastics used in EEE (electrical and electronic equipment) ................................................................ 38

Table 19: Scenario Management Tableau of the Socio Economic Analysis regarding a ban of BBP as plasticiser for materials in EEE (electrical and electronic equipment) ............................................... 42

Table 20: Total releases of BBP (Source: COWI, 2009, Table 0-1) ................ 44



14 LIST OF FIGURES

Figure 1: Large-scale metal shredder plant (Source: Umweltbundesamt, 2008) ................................................................................................ 25

Figure 2: Manual sorting of disintegrated WEEE (Source: Umweltbundesamt, 2008) ................................................................ 25

Figure 3: Installation for further treatment of mixed shredder fractions (Source: Umweltbundesamt, 2008) ................................................. 26

rohs annex ii dossier for bbp

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