proposal for restriction of a substance in electrical … · proposal for restriction of a...

Substance Name: Bis(2-ethylhexyl)phthalate

EC Number(s): 204-211-0

CAS Number(s): 117-81-7

January 2014

ROHS ANNEX II DOSSIER DEHP

Proposal for restriction of a substance in electrical

and electronic appliances under RoHS

ROHS Annex II Dossier DEHP

January 2014 3

Contents

1 IDENTIFICATION, CLASSIFICATION AND LABELLING, LEGAL STATUS AND USE RESTRICTIONS ......................................................................... 5

1.1 Identification 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 restriction .......................................................... 8

2 USE OF DEHP ......................................................................... 10

2.1 Use and function of the substance ................................................... 10

2.2 Use of DEHP in EEE ............................................................................ 10

2.3 Quantities of DEHP used in EEE ....................................................... 10

3 HUMAN HEALTH ..................................................................... 12

3.1 Human health hazard .......................................................................... 12

3.2 Endpoints of concern ......................................................................... 12

3.2.1 Existing Guidance values ...................................................................... 17

4 ENVIRONMENT ....................................................................... 19

4.1 Environmental fate properties ........................................................... 19

4.2 Environmental hazard ......................................................................... 20

4.2.1 Eco-toxicity ............................................................................................ 20

4.2.2 Potential for secondary poisoning ......................................................... 20

4.3 Existing guidance values (PNECs) .................................................... 21

5 WASTE MANAGEMENT OF ELECTRICAL AND ELECTRONIC EQUIPMENT .................................................... 22

5.1.1 WEEE categories containing DEHP ..................................................... 22

5.1.2 Relevant waste materials/components containing DEHP ..................... 22

5.2 Waste treatment processes applied to WEEE containing DEHP .................................................................................................... 23

5.2.1 Treatment processes applied ................................................................ 23

5.2.2 DEHP flows during treatment of WEEE ................................................ 24

5.2.3 Treatment processes selected for assessment under RoHS ............... 27

5.3 Releases from the relevant WEEE treatment processes ................ 28

5.3.1 Shredding of WEEE .............................................................................. 28

5.3.2 Shredding of cables .............................................................................. 31

5.3.3 PVC-Recycling ...................................................................................... 32

5.3.4 Summary of releases from WEEE treatment ........................................ 33

6 EXPOSURE ESTIMATION ....................................................... 34

6.1 Human exposure ................................................................................. 34


4 January 2014

6.1.1 Exposure estimates of workers of EEE waste processing plants .....................................................................................................35

6.1.2 Monitoring of human exposure at EEE waste processing plants .....................................................................................................42

6.2 Environmental exposure ....................................................................44

6.2.1 Exposure estimates for the environment due to WEEE treatment ...............................................................................................45

6.2.2 Monitoring data: WEEE treatment sites/locations .................................49

7 IMPACTS ON WASTE MANAGEMENT ................................... 52

7.1 Impacts on WEEE management as specified by Article 6 (1) a .......................................................................................................52

7.2 Risks estimation for workers and neighbouring residents ............52

7.3 Risks estimation for the environment ...............................................53

8 ALTERNATIVES ...................................................................... 55

8.1 Availability of alternatives ..................................................................55

8.2 Hazardous properties of alternatives ................................................55

8.3 Conclusion on alternatives ................................................................58

9 DESCRIPTION OF SOCIO-ECONOMIC IMPACTS ................. 59

9.1 Approach and assumptions ...............................................................59

9.2 Impact on producers of plasticisers and plastics ...........................59

9.3 Impact on EEE producers ..................................................................60

9.4 Impact on EEE users ..........................................................................61

9.5 Impact on waste management ...........................................................62

9.6 Impact on administration ...................................................................62

9.7 Total socio-economic impact .............................................................62

10 RATIONALE FOR INCLUSION OF THE SUBSTANCE IN ANNEX II OF ROHS ............................................................ 64

11 REFERENCES ......................................................................... 70

12 ABBREVIATIONS .................................................................... 77

13 LIST OF TABLES ..................................................................... 78

14 LIST OF FIGURES ................................................................... 80


January 2014 5

1 IDENTIFICATION, CLASSIFICATION AND LABELLING, LEGAL STATUS AND USE RESTRICTIONS

1.1 Identification 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, 2008a)

Chemical name 1,2-Benzenedicarboxylic acid, bis(2-ethylhexyl) ester

EC number 204-211-0

CAS number 117-81-7

IUPAC name Bis(2-ethylhexyl)phthalate

Index number in Annex VI of the CLP Regulation

607-317-00-9

Molecular formula C24H38O4

Molecular weight range 390.6

Synonyms 1,2-Benzenedicarboxylic acid, bis(2-ethylhexyl) ester; Bis(2-ethylhexyl) 1,2-benzenedicarboxylate; Bis(2-ethylhexyl) o-phthalate; Bis(2-ethylhexyl) phthalate; Di(2-ethylhexyl) phthalate; Dioctyl phthalate; DOP (pseudo-synonym, incl. also other isomeric forms of the alcohol part); Phthalic acid dioctyl ester; Phthalic acid, bis(2-ethylhexyl) ester

Structural formula

Degree of purity app. 99.7%

Remarks --


6 January 2014

1.1.2 Physico-chemical properties

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

Table 2: Physico-chemical properties of DEHP (Source: ECHA, 2008a ;ECB, 2008)

Property Value

Physical state at 20°C and 101.3 kPa Colourless oily liquid

Melting/freezing point -55°C or -50°C

Boiling point 230°C at 5 mm Hg; 385°C at 1013 hPa

Vapour pressure 0.000034 Pa at 20°C

Water solubility 3 µg/l at 20°C

Partition coefficient n-octanol/water (log POW) 7.5

Dissociation constant --

Flashpoint 200°C

Autoignition temperature 370°C

Henry´s law constant 4.43 Pa m3/mol

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 the proper handling, including manufacture, use and transport of hazardous substances.

DEHP is listed in Annex VI to the CLP Regulation and is harmonised classified as Repr. 1B (H360FD) (Table 3) and labelled with GHS08 Dgr, H360FD.

In accordance with Directive 67/548/EEC DEHP is classified as Repr. Cat. 2; R60-61 (may impair fertility/may cause harm to the unborn child) and labelled with T R60, R61, S53, S45.

In addition to the harmonised classification DEHP has been self-classified as Lact. (H362), Aquatic Chronic 3 (H412), Aquatic Acute 1 (H400), Aquatic Chron-ic 1 (H410), Eye Irrit. 2 (HH319) by numerous manufactures and/or importers. Three notifiers have classified DEHP as Repr. 1A (H360) and one has classified the substance as Carc. 2 (H351). This information has been obtained from the C&L inventory provided by the European Chemicals Agency2.

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

RO

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Table 3: Harmonized classification of DEHP1

Index No International Chemical Identification EC No CAS No Classification Labelling

Spec. Conc. Limits, M-factors Notes

Hazard Class and Category Code(s)

Hazard statement code(s)

Pictogram, Signal Word Code(s)

Hazard statement code(s)

Suppl. Hazard statement code(s)

607-317-00-9

DEHP di-(2-ethylhexyl) phthalate bis(2-ethylhexyl) phthalate

204-211-0 117-81-7 Repr. 1B H360FD GHS08

Dgr

H360FD -- -- --

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 (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


8 January 2014

1.3 Legal status and use restriction

Registration, Evaluation, Authorisation and Restriction of Chemicals

(REACH) Regulation3,4

DEHP is included in Annex XIV - list of substances subject to authorisation - of the REACH Regulation. Specific authorisation for DEHP will be required for a manufacturer, importer or downstream user to place the substance on the mar-ket, use it in preparations or for the production of articles. DEHP cannot be placed on the market or used after 21 February 2015, unless an authorisation is granted for the specific use or the use (e.g. medical devices) is exempted from authorisation.

Furthermore, an Annex XV proposal has been submitted by Denmark for the four phthalates DEHP, BBP, DBP and DIBP. Within the report, Denmark pro-poses a ban on placing on the market articles intended for indoor use and in ar-ticles that may come into direct contact with the skin or mucous membranes containing one or more of these four phthalates in a concentration greater than 0.1 % by weight of any plasticised material (DEPA, 2011).

The RAC committee, however, considers that the proposed restriction is not jus-tified because the available data do not indicate that currently there is a risk from combined exposure to the four phthalates, due to already taken risk reduc-tion measures (ECHA, 2012c).

Specific restrictions for certain phthalates in toys and childcare articles are al-ready in force. DEHP is included in Annex XVII (restrictions on the manufacture, placing on the market and use of certain dangerous substances, preparation and articles) to the REACH Regulation (Annex XVII, group 51)5.

For three phthalates, including DEHP, the following restriction conditions have to be taken into consideration:

� in toys and childcare articles DEHP, Benzyl Butyl Phthalate (BBP) and Dibu-tyl-phthalate (DBP) shall not be used as substance or in mixtures in concen-trations greater than 0.1 % by weight of plasticised material;

� toys and childcare articles containing DEHP, Benzyl Butyl Phthalate (BBP) and Dibutyl-phthalate (DBP) in a concentration greater than 0.1 % by weight of plasticised material shall not be placed on the market.

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 Re-

gistration, Evaluation, Authorisation and Restriction of Chemicals ( ‘REACH’ ) 5 Commission Regulation (EC) No 552/2009 of 22 June 2009 amending Regulation (EC) No

1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Author-

isation and Restriction of Chemicals (REACH) as regards Annex XVII


January 2014 9

Food Contact Material Regulation6

In the European Union certain restrictions on the use of DEHP in food contact materials have been implemented.

DEHP can be used as plasticiser in repeated use materials and for articles con-taining non-fatty foods provided the migration of the plasticiser does not exceed the Substance Migration Limit (SML) of 1.5 mg/kg food.

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

Cosmetic Regulation7

The use of DEHP is prohibited in the production of cosmetic products. It is listed in Annex II – list of substances prohibited in cosmetic substances- to the Cos-metics Regulation.

Environmental quality standards8

Furthermore, the substance is listed in Annex I to the Directive on environmen-tal quality standards (2008/105/EC) in the field of water policy. The annual av-erage environmental quality standard (AA-EQS) value should not exceed 1.3 µg/l in inland and other surface waters.

DEHP is in the list of pollutants (Annex II) which should be recorded via the Eu-ropean Pollutant Release and Transfer Register.9

6 Commission Regulation (EC) No 10/2011 of 14th January 2011 on plastic materials and articles in-

tended to come into contact with food 7 Regulation (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of

30 November 2009 on cosmetic products 8 Directive 2008/105/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 De-

cember 2008 on environmental quality standards in the field of water policy 9 Regulation (EC) No 166/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of

18 January 2006 concerning the establishment of a European Pollutant Release and Transfer

Register and amending Council Directives 91/689/EEC and 96/61/EC


10 January 2014

2 USE OF DEHP

2.1 Use and function of the substance

DEHP is predominantly used (up to 97%) as a plasticiser in polymer products (mainly PVC). The content of DEHP in flexible polymer products varies, but is often up to 30%. Only a small percentage of DEHP is used as plasticiser in pol-ymers other than PVC and non-polymers (COWI, 2009).

In general, phthalates are not chemically bound to the polymer matrix and are therefore used as so-called external plasticisers.

The substance group can migrate from the plasticised polymers by e.g. extrac-tion with soapy water/oils, by evaporation and by diffusion.

2.2 Use of DEHP in EEE

The predominant use of DEHP in EEE is in flexible PVC in cables and wires.

Minor uses of DEHP include the following non polymer uses: in ceramics for electronics or as dielectric fluids in capacitors

10.

2.3 Quantities of DEHP used in EEE

Information on the overall consumption and production of DEHP in the EU is available from several studies conducted in the context of the application of the REACH Regulation.

DEHP was manufactured in the European Union in a volume of approximately 340.000 tonnes/year in 2007 (COWI, 2009) and the net use of DEHP in the EU was estimated to account for approximately 280,000 tonnes/year in 2007 (ECHA, 2009).

The use of DEHP as plasticiser has decreased in the EU from 1999 to 2005 from 42% to 21% (Cadogan, 2006). According to information made available by the plasticiser industry the current share of DEHP in the total European plasti-ciser market is 11%11. The market share of DEHP in total phthalates decreased from 2001 to 2010 from over 35% to less than 15% (vinylplus, 2013).

A large proportion of flexible PVC in general, and of cables and wires in particu-lar, is used for other uses than EEE. PVC-cables are also used for installations in buildings, industrial facilities and infrastructure).

On the basis of various different information sources (e.g. COWI, 2009, Anders-son, 2005; ECB, 2008; PlasticsEurope, 2007), the Danish Environmental Pro-

10 compare Ökoinstitut (2008); http://echa.europa.eu/web/guest/addressing-chemicals-of-

concern/authorisation/applications-for-authorisation 11 http://www.plasticisers.org/en_GB/plasticisers/low-phthalates

Main us of DEHP

in EEE

DEHP quantity in

European EEE


January 2014 11

tection Agency estimated in 2010 that the EEE marketed in the EU contain ap-proximately 5,000 to 20,000 t/y of DEHP (DEPA, 2010).

In 2010 9.4 Mio tonnes of EEE were placed on the market in the EU stat12). Assuming a plastic content in EEE of 30% of the appliances’ weight13, a 12% share of the EEE plastics being PVC14, a plasticiser content in PVC of 20-60%15, and a 11% share of DEHP within used plasticizers16 would lead to an assumption of 7,444 to 22,334 tonnes17.

For non-European markets, where REACH does not apply, it cannot be as-sumed that the same degree of reduction of DEHP has taken place during the previous years. As a considerable percentage of EEE is produced abroad, in the current assessment the upper value of the range estimated by DEPA is used: it is assumed that 20,000 tonnes of DEHP (present in EEE) are put on the market each year.

12Waste Electrical and Electronic Equipment (WEEE) statistics (env_waselee):

http://appsso.eurostat.ec.europa.eu/nui/show.do?dataset=env_waselee&lang=de; extracted

August 2011 13 See e.g. Schlummer et al (2007) 14 VKE, 2003 15 IPTS, 2013 16 DEPA, 2010 17 9,400,000 * 0.3 *0.2*0.12*0.11= 7,444 t // 9,400,000 * 0.3 *0.2*0.12*0.11= 22.334 t


12 January 2014

3 HUMAN HEALTH

3.1 Human health hazard

DEHP’s toxicity has been reviewed extensively in the recent past. For example, in the year 2008 an in-depth evaluation of the potential risk of DEHP to human and/or environmental health was performed within the EU risk assessment re-port series (ECB, 2008) and a re-evaluation considering a potential carcinogen-ic effect was carried out by the International Agency of Cancer Research in 2013 (IARC, 2013).

The main findings of the assessments are summarised in brief below. A more detailed description of the endpoints of concern is included in chapter 3.2.

The acute toxicity of DEHP is low. The oral LD50 is >20g/kg bw in rats and >40g/kg bw in mice. Toxicological studies have revealed that the compound is only very slightly irritating to the skin and eye but not corrosive and not sensitiz-ing to the skin.

DEHP lacks mutagenic potential in vitro and in vivo. However, carcinogenicity studies reveal that DEHP induces liver tumours in rats and mice. It has been hypothesised that the liver tumours are induced by a non-DNA reactive mecha-nism involving peroxisome proliferation. Therefore, the mechanism by which DEHP induces hepatocellular tumours in rodents was supposed to be of minor relevance for humans (IARC, 2000). Authors of a recent review, however, pos-tulate that the drawn conclusion that PPARα agonists (such as DEHP) pose no risks to humans should be re-examined (Guyton et al., 2009). Furthermore, oth-er tumour sites (Leyding cell and pancreatic acinar cell tumours) have been ob-served in rodent studies, the significance of which for humans cannot be unam-biguously clarified. The non-hepatic tumours may be mediated through mecha-nisms independent of peroxisome proliferation (NRC, 2008). A recent re-evaluation of DEHP’s carcinogenic properties carried out by the International Agency of Research on Cancer (IARC) with consideration of new available data revealed that DEHP is classified as possible carcinogen to humans group 2B (IARC, 2013).

Outcomes of repeated dose toxicity and developmental and reproductive

toxicity studies are in more detail depicted in the following section.

3.2 Endpoints of concern

DEHP possess adverse effects on the reproductive and developmental sys-

tem in rodents of both sexes. Furthermore DEHP exposure has a negative im-pact on testis, kidney and liver as observed in repeated dose toxicity studies.

Detailed findings of individual studies are presented in the EU risk assessment report (ECB, 2008) and are not discussed in the present assessment. Instead, Table 4 below depicts studies which have been identified as key studies in re-gard to further risk characterisation within the EU RAR.

DEHP exposure affects the reproduction in rodents of both sexes and induces developmental effects in off-springs. Severe toxic effects to the testis have been observed in developmental toxicity studies with experimental animals, as well

Hazard assessments

in brief

Acute toxicity/

Irritating and

sensitising

properties

Mutagenicity and

carcinogenicity

Reproductive and

developmental

effects


January 2014 13

as in repeated dose toxicity studies. Depending on the study design DEHP pos-sesses different severe adverse effects on fertility, decreased weight of male reproductive organ and histopathological changes in the testis.

Developmental effects due to DEHP exposure have been observed in various studies, including intra-uterine death, developmental delay and structural mal-formations and variations (for details see ECB, 2008). Testicular toxicity and developmental toxicity, observed in different animal species and at relatively low dose levels are considered relevant to humans.

An evaluation by the of existing studies revealed that the three-generation study carried out by Wolfe et al. (Wolfe et al., 2003) is the most appropriate further risk characterisation (ECB, 2008, RAC, 2013). The study has been considered for the derivation of the derived no effect level (DNEL) recently carried out by the risk assessment committee (see chapter 3.2.1) (RAC, 2013).

Based on this study, in which DEHP was administered orally with the diet to Sprague Dawley rats, a NOAEL of 4.8 mg/kg bw/ day was established. Testicu-lar toxicity at this dose level has been observed in the F0 generation. The NOAEL for fertility effects in this study is 46 mg/kg bw. Adverse effects include impaired fertility and altered sperm and litter parameters.

The rat seems to be the most sensitive species to DEHP induced malfor-mations. Irreversible testicular damage was detected in male pups exposed in utero and during suckling already at very low dose levels (LOAEL = 3.5 mg/kg bw/day) (Arcadi et al., 1998). In comparison, the lowest NOAEL observed in studies carried out with mice for developmental toxicity is 20 mg/kg bw (Lamb et al., 1987).

Human health effects from phthalates at low environmental doses or at biomoni-tored levels are under debate. Reviewing articles summarising human toxicity and epidemiological data indicate knowledge and/or data gaps and the need for further investigations (Lyche et al., 2009, Vanessa et al., 2013, Jurewicz et al., 2011). Especially, studies identifiying the relationship between phthalate expo-sure and female reproductive system are sparse (Lyche et al., 2009, Vanessa et al., 2013).

Recently a systematic review of studies investigating the relationship of phthalate exposure and reproductive and developmental effects in females has been published (Vanessa, 2013). The authors state, that the epidemiological studies carried out so far have several drawbacks (e.g., small sample size, methodolog-ical weakness), to draw any firm conclusion more information is needed.

More studies are available investigating the effect of reproductive and devel-

opmental effects in males. Some epidemiological studies demonstrate an as-sociation between phthalate exposure and disturbance of normal sperm func-tion, such as fewer motile sperm, low sperm concentration and motility, sperm malformations and increased DNA damage (Lyche et al., 2009, Jurewicz et al., 2011). Further study outcomes show that phthalate exposure adversely affects the level of reproductive hormones (e.g., luteinizing hormone, free testosterone, sex hormone-binding globulin), anogenital distance and thyroid function (Lyche et al., 2009, Jurewicz et al., 2011).

The observation from rodent studies that phthalate exposure alter the angi-ogenital distance (AGD), which is an endpoint for hormonally regulated sex dif-ferentiation, has been confirmed for the first time in a human study conducted

NOAEL used for

DNEL derivation

Phthalate exposure:

Review of human

studies


14 January 2014

by Swan et al. (2005). Concentrations of four prenatal measured urinary phthalate metabolites were inversely related to ADG. In a review contacted by Swan et al. (2008) it is also depicted that recent human findings are in consist-ence with the anti-androgenic action that have been demonstrated for phthalates in animal studies.

Furthermore, epidemiological studies indicate a relationship between childhood phthalate exposure (e.g, through house dust) and risk of allergic diseases in-cluding asthma and eczema. Moreover, In some studies alterations in child be-haviour has been associated to phthalate exposure (Braun et al. 2013, Jurewicz, 2011).

A summary of recent epidemiological human studies and observations in hu-mans related to DEHP exposure and adverse impact is given in a report of the Californian Environmental Protection Agency (OEHHA, 2009).

The authors, of the report concluded, that the evidence for adverse effects in humans regarding DEHP impact on adverse effects on male reproductive sys-tems are less conclusive, as the outcome of experimental animal data. Although less intensively studied, there is evidence that DEHP has an adverse impact on the female reproductive system. Adverse effects observed, include reduction of numbers or corpora lutea, delayed vaginal opening, increase in ovarian and uterine weights.

In vitro as well as in vivo studies demonstrate that DEHP has an impact on the endocrine system. DEHP is supposed to exert an anti-androgenic effect (ECB, 2008). There is evidence from experimental animal studies that DEHP has an impact on thyroid glands, nervous and immune system, as well as on the onset of obesity. These effects are supposed to be related with DEHPs potential to in-fluence the endocrine system.

DEHP is in the EU EDS database listed as one of the 66 potentially endocrine substances with classification of high exposure concern (EC, 2000). DEHP 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).

A recent evaluation of the International Agency for Research on Cancer (IARC) revealed that DEHP is possibly carcinogenic to humans (Group 2B). In animal experiments there is clear evidence that DEHP induces tumours (in particular hepatic tumours). Relevance for the tumour development in humans cannot be ruled out. It has been demonstrated that multiple molecular signals and path-ways in several cell types and not only a single molecular event plays a role in the hepatic tumour development (IARC, 2013).

Repeated dose toxicity studies identified testis, kidney and liver as the main tar-gets of DEHPs toxicity. The NOAEL for kidney toxicity is 29 mg/kg/day in the males and 36 mg/kg/day in females, derived from a chronic 2-year study in rats (Moore, 1996).

The effects on the kidneys include increased (i) absolute and relative kidney weights, (ii) incidence and severity of mineralization of the renal papilla, (iii) in-cidence of tubule cell pigments, and (iv) incidence and/or severity of chronic progressive nephropathy.

Epidemiological

studies and DEHP

exposure

Endocrine

disruption

Cancer

Repeated dose

toxicity


January 2014 15

In the liver, hepatomegaly due to hepatocyte proliferation, peroxisome prolifera-tion and hepatocellular tumours are observed in experimental animals, but the hepatic effects are not believed to be relevant for humans.

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Table 4 : Examples of key developmental and repeated-dose toxicity studies (Source: ECB, 2008)

Study type Species Application and exposure levels

Outcome LOAEL(*) NOAEL(*) Reference

Reproductive toxicity

Three-generation study (according to OECD guideline 416)

Crl:CD(SD) rats; males and females

Orally; in the diet.

1.5; 10; 30; 100; 300 1.000; 7.500; 10.000 ppm

Testicular toxicity as well as developmental toxicity including:

Decreased absolute and relative testis weight in F0, F1 and F2 animals

Small and aplastic testis; testis seminiferous tubular atrophy

Decrease in size of epidymidis, seminal vesicles and prostate

Decrease in the pregnancy indices and number of pups

14 mg/kg bw/day

4.8 mg/kg bw/day for testicular toxicity;

46 mg/kg/day for fertility

Wolfe et al., 2003

Continuous breeding study (GLP and guideline study)

CD-1 mice; males and females

0, 20, 200 or 600 mg/kg bw/day

Dose-dependent decreased fertility; reduced number of litters and proportion of live pups; both sexes were effected

Reduced weight of reproductive organs.

200 mg/kg bw/day 20 mg/kg bw/day Lamb et al., 1987

Repeated dose toxicity

2 years

(according to GLP principles, comparable to guideline study)

F-344 rats, males and females

Orally; in the diet

0, 5.8, 28.9, 146.6 or 789.0 mg/kg/day, respectively, for males, and 0, 7.3, 36.1, 181.7 or 938.5 mg/kg/day, respectively, for females

Increased absolute and relative kidney weight

Dose dependent effects to kidney. More severe kidney lesions were observed at the highest dose level

Further effects:

Increased liver weight (males) and peroxisome proliferation

Alteration of pituitary gland, testes and spermatogenesis;

Changes in the kidneys, testes, and pituitary were not reversible upon cessation of exposure

Hepatocarcinogenicity in both sexes.

147 mg/kg bw/day 29 mg/kg bw/day Moore, 1996


January 2014 17

3.2.1 Existing Guidance values

An overview on the 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, 2013). OELs and guideline values in different countries are between 3-10 mg/m3 (GESTIS, 2013). No OEL has been derived by the European Scientific Commit-tee on Occupational Exposure limits for DEHP (SCOEL) so far. The German maximum workplace concentration value (MAK) for example is 10 mg/m3. The threshold limit value (TLV) of the American Conference of Governmental Indus-trial Hygienists (ACGIH) is 5 mg/m3 (IARC, 2013).

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 0.05 mg/kg bw/day (EFSA, 2005). Likewise, as for the DNEL deri-vation the outcome of the study of Wolfe et al. (2003) was used as point of de-parture (POD).

The “Derived No-Effect Level” (DNEL) is the level of exposure to the substance above which humans should not be exposed.

For the present assessment DNELs, which have been critically analysed within the European risk assessment committee (RAC, 2013) are used for further risk characterisation.

In Table 5 the different determined DNELs by the RAC for oral, inhalative and dermal exposure are depicted.

The POD of 4.8 mg/kg bw for DEHP has been derived from a three generation study the of Wolfe et al. (2003), in which testicular toxicity has been observed. The POD is regarded as conservative, since low incidences have been ob-served at the LOAEL.

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).

The corrected NOAEL has been deduced by adjusting differences in oral ab-sorption between rats (70%) and humans (100%). Applying the overall assess-ment factor of 100 an oral DNEL of 0.034 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 followed by a correction for differences in absorption between routes (70% oral absorption in rats, 75% in-halation absorption in humans) (RAC, 2013). For children a 100% absorption instead of 75% absorption for adults has been assumed.

Occupational

exposure limits

Tolerable daily

intake

Derived no effect

level for DEHP

Point of departure

Assessment factors

Oral DNEL

Dermal DNEL

DNEL inhalation


18 January 2014

Table 5: Overview of the deduced DNELs for DEHP (Source: RAC, 2013)18

Assessment

Factors

Workers General population

(Adults& Children)

Interspecies 4 4

Interspecies, remaining differences 2.5 2.5

Intraspecies 5 10

Dose response (LOEAL to NAEL) 1 1

Quality of database 1 1

Applied Factor* 50 100

ORAL

Absorption (%) 100% 100%

NOAEL corrected (not relevant) 3.36

DNELs ORAL in mg/kg/d (not relevant) 0.034

DERMAL

Absorption (%) 5% 5%

NOAEL (corrected) 94.1 67.2

DNELs DERMAL in mg/kg/d 1.882 0.672

INHALATION

Absorption (%) 75% 75% (Adults)

100% (Children)

Standard respiratory volume in m3/kg

bw per day

0.38 1.15

NOAEC (corrected) 11.0 3.90 (Adults)

2.92 (Children)

DNECs INHALATION in mg/m3 0.88 0.16 (Adults)

0.12 (Children)

* interspecies assessment factor was not applied when calculation inhalation DNECs

Within the EU risk assessment report the risk characterisation was based on the Margin of Safety approach. It has been concluded that the margin of safety is not sufficient and that there are concerns for testicular effects, fertility, toxicity to kidneys, on repeated exposure and developmental toxicity as a consequence of inhalation and dermal exposure during production, processing and industrial end-use of preparations or materials containing DEHP.

The conclusion was further that there is a need for limiting the risks; risk reduc-tion measures which are already applied shall be taken into account.

18 more details on DNEL derivation are described in following ECHA document

http://echa.europa.eu/documents/10162/13579/rac_24_dnel_dehp_comments_en.pdf

Outcome of EU risk

assessment (2008)


January 2014 19

4 ENVIRONMENT

Within the frame of the EU risk assessment series an in-depth characterisation of DEHP has been published in the year 2008 (ECB, 2008).

In the following section the environmental fate properties of DEHP are de-scribed as well as a summary of the results of eco-toxicity studies is given

Predicted no effect levels depicted in chapter 4.3 have been previously deduced by EU RAR (ECB, 2008).

4.1 Environmental fate properties

DEHP is readily biodegradable based on standard experimental biodegradation tests. Photodegradation of DEHP is important in the atmosphere. However, it is assumed to be of little importance in water and soil. No hydrolyses of DEHP in water takes place. The main degradation product of DEHP is Mono(2-ethylhexyl)phthalate (MEHP).

Experimental data indicate a half-life for DEHP in surface water of 50 days and 300 days in aerobic sediments. Anaerobic conditions and low temperature re-duce the degradation rate. A low to moderate biodegradation rate is seen in studies with agricultural soil. Because of the slow degradation capacity under anaerobic conditions and the lipophilic nature of DEHP, the compound is often found in high concentrations in sediment.

DEHP is found to bio-accumulate in aquatic organisms. The highest bioaccumu-lation factor (BCF) value was observed for invertebrates e.g. 2,700 for Gam-marus. The BCF for fish is 840. Monitoring data for different trophic levels, indi-cate that DEHP does not bio-magnify.

Due to the high log Kow value of DEHP (7.5), the substance is expected to be strongly adsorbed to organic matter and to be present in the solid organic com-partments of the environment.

The log Koc for DEHP is 5.2. Hence, DEHP will be strongly adsorbed to the or-ganic matter (e.g., sewage treatment plant material). Due to its high affinity to organic matter only a limited bioaccumulation of DEHP in plants is expected. The outcome of environmental studies confirms this assumption with measured BCF values ranging between 0.01 and 5.9.

Biodegradation

Persistence

Bioaccumulation


20 January 2014

Table 6: Selected environmental parameters in comparison with PBT and POPs criteria

Parameter Outcome PBT criteria (according REACH, Annex XIII)

POPs criteria (Stockholm Convention)

Half-lives Surface water Aerobic sediments

50 ds 300 ds

40 ds

120 ds

>60 ds

>180 ds

Log Kow 7.5 -- >5

Log Koc 5.2 -- --

Bio-concentration factor

840 (bio-concentration tests with fish) 2700 (Grammarus)

>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 potential to damage human health or the environment

Overall, DEHP does not fulfil neither all Persistence, Bioaccumulative and Toxic (PBT- criteria) criteria stipulated in Annex XIII of the REACH regulation nor all criteria of Annex D of the international Stockholm Convention. But as can be seen above it is a borderline case and has the potential to bio-accumulate.

4.2 Environmental hazard

4.2.1 Eco-toxicity

Studies carried out to determine possible adverse effects to the aquatic organ-

ism indicate that DEHP does not possess any adverse effects at concentrations below the water solubility. Also the highest tested concentration of 1,000 mg/kg dwt, did not show any adverse outcome on sediment organisms under the test conditions.

There is only one valid study, which investigates possible adverse effects of DEHP on microorganism (respiration in activated sludge). No effects were ob-served up to the highest doses tested (2.01 mg/l).

For the atmosphere no studies are reported from which a guidance value (see chapter 4.3) could be derived (ECB, 2008.

The studies on soil organism have demonstrated no adverse effects due to DEHP exposure up to the highest concentration tested. Therefore, for the terrestrial

compartment a NOAEC of ≥ 130 mg/kg dwt has been deduced.

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 bio-magnification properties within the food chain may pose an additional threat.

Main conclusion of

eco-toxicity studies


January 2014 21

A NOEC of 33mg/kgfood for mammalian predators has been determined in the frame of the EU RAR (ECB, 2008). The NOEC is based on the study of Wolfe et al. (2003), in which testicular damage in rats has been observed (details see Table 7). For effects on reproduction in birds a NOEC of 1,700 mg/kgfood has been observed.

DEHP has shown an effect on fish exposed to DEHP via the diet, a NOAEC of 160 mg/kgfood has been determined for the aquatic compartment.

4.3 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 possible risks.

Based on the eco-toxicity studies PNECs have been deduced within the EU risk assessment report (ECB, 2008).

Therefore, it might be that PNEC values would vary considering toxicity studies not present at that time point.

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

Table 7: Deduced predicted no effect concentrations (PNECs) (Source: ECB, 2008)

Compartment NOEC Safety factor PNEC

Aquatic Compartment > 1000 mg/kg dwt 10 > 100 mg/kg dw

Atmosphere -- -- no PNEC derivation

Terrestrial Compartment >130 mg/kg dw 10 > 13 mg/kg dw

Secondary poisoning 33 mg/kg

1700 mg/kg

--

10

100

--

3.3 mg/kgfood (mammalians) 17 mg/kgfood (birds) 16 mg/kgfood (fish)

Secondary

poisoning

PNECs for different

compartments


22 January 2014

5 WASTE MANAGEMENT OF ELECTRICAL AND ELECTRONIC EQUIPMENT

5.1.1 WEEE categories containing DEHP

DEPA (2010) has already compiled an overview on the possible presence of DEHP containing parts in the 10 WEEE categories specified in Annex I to the WEEE Directive. Due to its generic use being wires and cables DEHP contain-ing parts are found in any kind of WEEE (Table 8).

Table 8: Possible presence of DEHP in the 10 WEEE categories as specified by Annex I

to the WEEE Directive (Source: DEPA, 2010)

5.1.2 Relevant waste materials/components containing DEHP

According to DEPA (2010) no information is available on the share of DEHP used in cables and wires compared to that in other applications in EEE (e.g. appliance´s feet). However for consumer electronics and large household appli-ances, it was estimated that at least half of the DEHP quantity is contained in in-ternal and external cables. These two EEE categories constitute more than half of total EEE. Information is also available on the amounts of use of DEHP in the EU (80% in cables, 20% in others19) , However it cannot be concluded that this is representative for WEEE entering the European market.

For the purpose of the present assessment it is assumed that 50% of DEHP used in EEE are contained in the fraction “cables” (i.e. 10,000 tonnes). The remaining 10,000 tonnes will be a part of mixed “plastics” streams.

19 E.g. from UK EA (2011)

Main materials/

components


January 2014 23

5.2 Waste treatment processes applied to WEEE containing DEHP

5.2.1 Treatment processes applied

5.2.1.1 Initial treatment processes

From WEEE, which are separately collected, external cables are in many cases manually removed as a first treatment step. The removal can take place either at the collection site or as an initial treatment step at installations for treatment of particular WEEE categories, such as installations for the treatment of cooling and freezing appliances or screens.

Further PVC parts, e.g. gaskets in refrigerators, will either be manually removed or separated after any shredding process and end-up most probably in mixed, plastics enriched fractions.

Mixed small WEEE will most likely undergo mechanical separation in a shred-

der process. These may be performed in large-scale metal shredders, in many cases combined with automated material sorting, or in shredders dedicated to WEEE (e.g. horizontal cross-flow shredders).

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 combustion process.

5.2.1.2 Subsequent treatment processes

The cables derived from dismantling are supposed to be treated in so-called cable shredders. These are usually cutting mills combined with some sorting technique, including air separation, sieving, vibration desks or wet density sepa-ration. The main aim of a cable shredder is to recover the metals .The obtained non-metal fraction is composed of the various polymers of which cables can be composed of: including PVC20, PE20, HDPE, VPE and rubber and a minor part of metals.

Mixed plastics fractions from cable shredding are either incinerated (MSW-incineration) land-filled or mechanically recycled.

The latter comprises several physical steps including cutting, shredding, sorting, contaminants separation, floating, melting, extrusion, injection moulding etc. Usually such processed plastic waste is admixed with virgin plastics of the same type for producing new articles, or used on its own for alternative (usually lower value) articles. According to VinylPlus (2013) recycled flexible PVC is predominantly used for the following applications: materials used in the con-struction sector (outdoors and indoors, floors), road equipment, footwear. Fur-ther products are mats, garden hoses etc.

20 According to Bipro (2002) approximately 60% are PVC, 30% PE

Treatment of

separately collected

WEEE

Treatment of WEEE

ending up in

unsorted MSW

Treatment of WEEE

shipped to third

countries

Treatment of cables

Treatment of

plastics from cable

shredding


24 January 2014

Plastics containing fractions resulting from shredding of WEEE are usually ei-ther:

� Land-filled

� 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 DEHP 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

Treatment of cables in third countries can also be open burning and smoulder-ing.

5.2.2 DEHP flows during treatment of WEEE

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

It is assumed that the DEHP-input into waste management by WEEE corre-sponds to the total quantity of DEHP put on the European market via EEE21, i.e. 20,000 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 DEHP entering individual treatment processes in par-ticular 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 using European WEEE statistics (Eu-rostat, WEEE data for 201022), assumptions made by EC (2008b) based on fig-ures for 2005 and on own estimations.

WEEE treated in WEEE treatment plants in the EU

44 %23 of the overall WEEE arising24 are treated in WEEE treatment plants in

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

21 Based on 9.4 Mio EEE put on the market 2010 22 Eurostat: Waste Electrical and Electronic Equipment (WEEE) statistics (env_waselee); extracted

August 2013 23 WEEE reported to be collected separately, including also 11% of WEEE (particularly large

household appliances) not reported to be separately collected but treated by the same process-

es as the comparable appliances reported as being separately collected.

Treatment of

shredder residues

Treatment of cables

in third countries

Waste management

scenario for DEHP

containing WEEE

Assumptions


January 2014 25

Taking into account also the composition of WEEE that are reported to be sepa-rately collected (Eurostat, WEEE- statistics25) 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% manual dismantling, 70% shredder)

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

Furthermore, it is assumed that of all WEEE being separately collected as an in-itial treatment (before shredding or manual dismantling) 80% of the cables are cut off.

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-ated26.

WEEE whose fate is unknown

41 % of the overall WEEE arising (3.9 Mio t/a) are unaccounted and are as-sumed to be shipped to third countries to an unknown degree.

Re-use of WEEE

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

Treatment of cables

It is assumed that the whole quantity of the cables removed manually from WEEE is treated in cable shredders. Assuming an average content of cables in WEEE of 2%27 this amount is approximately 66,000 tonnes of cables28.

COWI (2009) estimate that DEHP containing wastes are predominantly inciner-ated or landfilled but not recycled. However, indication is given that recycling of PVC waste resulting from cables will increase. VinylPlus report about 80.000 t of waste PVC cables being recycled in 2010. In 2012 88,400 t were recycled

24 For the purpose of the present assessment the WEEE arising is seen equal to the amounts put

on the market 25 The shares of individual categories in the amounts reported to be separately collected were used 26 See for example EEA (2013) 27 Derived from figures for small WEEE in Salhofer & Tesar (2011) 28 4,100,000*0,8*0,02 = 65,600


26 January 2014

(Vinylplus, 2013) Information to which extent these cables stem from WEEE is currently not available29.

For the purpose of the current assessment it is assumed that one third of PVC resulting from shredding of cables is incinerated, one third is landfilled and one third is sent to mechanical recycling.

Treatment of shredder residues

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

It is assumed that 2/3 of shredder residues, respectively mixed plastics enriched fractions are landfilled and one third is incinerated.

Based on the material composition of WEEE and the estimates described in Chapter 2.3 “Quantities of DEHP used in EEE” an average DEHP content in WEEE of 0.213 % is assumed30. Half of the contained DEHP is in cables, half in other parts31.

Based on these assumptions the following DEHP quantities entering the indi-vidual treatment processes were estimated (see Table 9 below).

29 What is known is the compostion of the cable waste airising. According to a modeling tool devel-

oped by the European Plastic converters in 2012 250,000 tonnes were cables from building ap-

plications. Less than 170,000 tonnes were cables from E&E 30 20.000 tonnes of DEHP are contained in 9.4 Mio tonnes of EEE � average DEHP concentration

in WEEE = 0.213% 31 Information on the shares of DEHP containing cables and of other DEHP containing other PVC

parts broken down per individual WEEE categories is not available

DEHP input into

WEEE treatment

processes


January 2014 27

Table 9: Estimated quantities of DEHP entering the main treatment processes for WEEE

and secondary wastes derived thereof (in tonnes per year)

WEEE (20,000) Secondary wastes

Separately collected

WEEE

WEEE in unsorted

MSW

WEEE shipped

out of the EU

Cables derived from

pre-treatment

Shredder residues

Secondary wastes from uncontrolled

WEEE treatment in

third countries

(incl. )

Re-Use 400c

Manual dismantling 2,550a

Shredding (and automated sorting)

3,750b 3,520

f

Landfilling (EU) 1,716d 1,173g 2,475h

Incineration (EU) 858e 1,173g 1,238i

Mechanical recycling (regrinding, pelletizing, extrusion etc.)

1,173g

Uncontrolled treatment in third countries (dismantling, dumping, smouldering, open burning)

8,200j

a...20,000 t * 0.44 * 0.29

b...20,000 t * 0.44 * 0.71 without DEHP contained in 80% of cables cut off from WEEE before shredding (2,500 t) �

c…2% of 20,000 t

d…20,000 t * 0,13 * 0.66

e…20,000 t * 0,13 * 0.33

f…20,000 t * 0.44 * 0.5 * 0.8

g…3,520 t / 3 (PVC from cable shredding)

h…3750 t * 2/3

i…3750 t *12/3

j…20,000 t * 0.41

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 processes were selected as most relevant for the present risk assessment:

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

� Mechanical treatment of cables in “cable shredders”, because it is a well de-fined process carried out at large number of installations. There is a consid-erable generation of cables from other waste sources than WEEE, including cables for domestic installations or cables for information and power system cables. Separate treatment of WEEE cables is possible in principle and the

Relevant processes


28 January 2014

effects of DEHP containing WEEE cables can be evaluated seperately (in a scenario).

� Recycling processes for PVC, because recycling of PVC, including PVC de-rived from WEEE-cables, is considered an increasing activity. Drivers are the European PVC industry´s voluntary commitment to increase PVC recycling (VinylPlus 2013) and legally binding recycling targets for several waste streams.

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.

� Land-filling, because WEEE and materials derived thereof are not the main source for DEHP in the landfilled waste usually.

� Incineration under controlled conditions, because WEEE and materials de-rived thereof are not the main source for DEHP in the incinerated waste usu-ally. 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 DEHP.

5.3 Releases from the relevant WEEE treatment processes

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

5.3.1 Shredding of WEEE

The most important route of DEHP from shredding of WEEE or plastics materi-als 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 BAT-Reference Document for the Waste Treatment Industries (BREF WTI) (IPPC, 2006) generic emission levels for dust (PM) associated to the use of BAT are in the range of 5-20 mg/Nm3. However, treatment of metal wastes, including WEEE, in shredders has been included in-to the scope of IED-Directive recently. Information on the actual dust emissions from shredders under current operational conditions is scarce32.

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 fines. This is based on an assumption 18% generation of fines/dust from materials treated in a shredder and an emission factor of the dry material of 1 g/kg

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

(BDSV, 2012)

Less relevant

processes

Info on releases


January 2014 29

In order to estimate DEHP releases via diffuse emissions of dust during ma-nipulating material streams at sites where WEEE are shredded, the following assumptions were made:

� The total input of DEHP into WEEE shredders was estimated to account for 3,750 t/a (compare DEHP flows in Table 9)

� 90% of the DEHP input into a shredder are transferred to fluff/fines/dust33

� 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)34

The total quantity of DEHP emissions via diffuse dust emissions from sites, where WEEE are shredded, is estimated to range from 338 kg/a to 3,375

kg/a35. The actual order of magnitude will depend on the degree to which BAT

for preventing diffuse emissions from handling of shredded materials including e.g. encapsulation of aggregates or wettening of materials is applied.

Having in mind that not all shredders in the EU apply BAT, the estimation of DEHP 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 Nm3/h36, and a treatment quantity of 60 t WEEE per hour37 were assumed. Furthermore, it was assumed that the concentration of DEHP in dust is the same as in the pro-cessed WEEE (1.3 g/kg38).

Based on these assumptions39 the total DEHP releases via residual dust emis-sions are about 24.8 kg/a

In order to estimate the DEHP emissions per installation 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 tonnes40

Based on the resulting daily DEHP input per installation of 325 kg and using the release factors for DEHP as illustrated above the following DEHP releases per installation and day are estimated:

� 29 to 292 g of DEHP are emitted diffusely via particulates

� 2.1 g of DEHP are emitted after de-dusting

33 Assumption based on Morf et al. (2004) 34 EC (2007) 35 RFair: 0.09 to 0.9 g/kg 36 E.g. described by Ortner (2012) 37 Umweltbundesamt (2008) 38 20,000 t / 9,400,000 t*0.6 (80% of cables containing of 50% of DEHP are assumed to be removed

from the WEEE before shredding) 39 Resulting RFair:0.0066 g/kg 40 Capacities of typical large scale-metal shredders: 25 – 60 t/h, assumption 7 working hours per

day

Assumptions

concerning diffuse

emissions

Estimates of diffuse

emissions

Assumptions

concerning

channelled

emissions

Estimates of

channelled

emissions

Releases per

installation and day


30 January 2014

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 DEHP 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.

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

Other mechanical 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-ered improvable.

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

Further

considerations

Workplace

description

mechanical

treatment of WEEE


January 2014 31

For the further 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-tion.

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 Shredding of cables

Detailed information on emissions or measures taken for prevention of emission of particulates from cable shredders is not available.

Thus the same release factors used for shredding of WEEE are used to esti-mate total diffuse and residual guided emissions.

It is estimated that 317 to 3,170 kg/a of DEHP are emitted via diffuse emissions and 23.2 kg/a after the de-duster.

In order to estimate the DEHP releases per installation and day from pro-cessing of cables the following assumption was made:

� The daily throughput in a cable shredder is 32 tonnes41

Based on the resulting daily DEHP input per installation of 1,701 kg42 and using the release factors for DEHP as illustrated above43 the following DEHP releases per installation and day are estimated:

� 153 to 1,532 g of DEHP are emitted diffusely

� 11.2 g of DEHP are emitted after de-dusting

41 Information on throughputs of cable shredders is available for example by is available from Um-

weltbundesamt (2008): 4 t/h to 12 t/h: Assumption: 8 working hours per day 42 10,000 t / 188,000 t of cables (2 % of 9,400,000 t) * 32 t 43 RFair channeled :0.0066 g/kg; RF air diffuse: 0.09 to 0.9 g/kg

Total releases

Releases per



32 January 2014

5.3.3 PVC-Recycling

Possible releases of DEHP during recycling of PVC derived from cables (or other PVC parts) may occur in particular through shredding, cleaning, prepara-tion, melting, pelletizing, transfer and storage and through polymer processing by calendaring, extrusion, injection moulding etc. to form the final plastic products.

For estimation of the releases from recycling of PVC in the present assessment the same release factors as applied for estimating the releases from the lifecy-cle stages 2b” Extrusion-compound” (Formulation � Compound) and 2f “Injec-

tion moulding/extrusion” (Downstream processing of PVC compound, where no raw materials are handled and no formulation takes place) by the EU-RAR on DEHP (ECB, 2008) are used. Furthermore, as assumed in the RAR for DEHP 50% of the releases were aligned to the air, the other 50% to waste water. Ac-cording to the RAR downstream processing of PVC-compound is assumed to be performed at a large number of small factories connected to a sewage treatment plant.

According to the RAR the total release factor for the process “2b” is 0.03%. The total release factor for “2f” is 0.01%.

Based on a total annual DEHP input into recycling processes of 1,173 t the fol-lowing total releases are estimated:

Formulation � Compound

� Releases to air: 176 kg/a

� Releases to waste water: 176 kg/a

Downstream uses (injection moulding/extrusion)

� Releases to air: 59 kg/a

� Releases to waste water: 59 kg/a

In order to estimate the DEHP releases from PVC recycling per installation

and day the following assumptions were made:

� 9 installations of an average size are involved in the formulation of PVC from WEEE cables44

� 9 installations of an average size are involved in the downstream use of PVC from WEEE cables

� Operation days per year: 220 (ECHA, 2012b, plastic recycling sector)

44 Basis for the assumption: The material composition of cables: two thirds of the cable are non-

metal fraction, 60% of that fraction is PVC (Bipro, 2002, Umweltbundesamt, 2008) � PVC-share

of cables: 39,6%. Thus from the 66,176 tonnes of cables being shredded (9,400,000 t * 0,02

*0,44 * 0,8) 26,205 tonnes of PVC result. One third thereof is assumed in the scenario to be re-

cycled: � appr. 8,700 tonnes. According to IPTS (2013) about 50,000 plastic converters process

about 46 Mio tonnes per year �average annual capacity of plastics converters of 1,000 tonnes.

� 9 plants of average size are involved in the treatment of appr. 8,700 tonnes of PVC.

Assumptions

concerning total

releases

Estimates of total

releases

Assumption of

releases per



January 2014 33

Based on a daily DEHP input per installation of 592 kg the following releases per installation and day are estimated:

Formulation � Compound

� Releases to air: 89 g/d

� Releases to waste water: 89 g/d

Downstream uses (injection moulding/extrusion)

� Releases to air: 30 g/d

� Releases to waste water: 30 g/d

5.3.4 Summary of releases from WEEE treatment

Table 10: Estimated total DEHP releases from WEEE treatment processes in the EU (in

kg per year)

Air (particulates) diffuse

Air (particulates)

Air (gaseous)

Water (waste water)

Shredding (and automated sorting) of WEEE 338 – 3,375 24.8

Shredding of cables 317 – 3,170 23.2

Recycling of PVC

Formulation 176 176

Injection moulding extrusion 59 59

Total 938 – 6,828 235

Table 11: Estimated local DEHP releases from WEEE treatment processes in the EU (in

g per installation and day)

Air (particulates) diffuse

Air (particulates)

Air (gaseous)

Water (waste water)

Shredding (and automated sorting) of WEEE 29 - 292 2.1

Shredding of cables 153 - 1,532 11.2

Recycling of PVC

Formulation 89 89

Injection moulding extrusion 30 30

Estimates of

releases per



34 January 2014

6 EXPOSURE ESTIMATION

6.1 Human exposure

Humans are exposed to DEHP via use of consumer products and indirect envi-ronmental exposure or due to occupational exposure. For the general popula-tion, food is considered as major source of DEHP exposure.

Monitoring studies demonstrate that DEHP is found in almost all dietary prod-ucts. DEHP in food might originate from the environment, food processing or food packaging. The dietary intake estimation for different regions of the world is in the range of 0.673- 21 µg/kg bw for adults (BfR, 2012; Fromme, 2007, Guo, 2012; Schecter, 2013).

DEHP oral exposure estimation via food consumption recently carried out by the BfR are between 10.1 to 21.3 µg/kg bw for adults, 6-15 µg/kg bw for adoles-cents and 6.5-15.1 µg/kg bw for children (BfR, 2012).

Children are additionally exposed to DEHP because of mouthing of toys and other consumer products (approx. 0,9-10,8 µg/kg bw) and to an even higher ex-tent due to ingestion of household dust (2,3-4,7 µg/kg bw).

In comparison, the inhalative exposure is approximately 10 fold less than the oral exposure. Also the dermal exposure is estimated to be low. There might be some significant dermal entry from wearing plastic shoes containing DEHP (2.4-10.3 µg/kg bw) (BfR, 2012).

Human breast milk can be a source of DEHP exposure for nursing babies. DEHP and metabolites were detected in human breast milk in numerous differ-ent bio-monitoring studies (e.g., Mortensen et al., 2005, Zimmermann et al., 2012, Main et al., 2006, Latini et al., 2009, Hines et al., 2009). Study outcomes indicate that DEHP concentrations in breast milk vary. A study conducted in Fin-land (n=65) and Denmark (n=65) showed a median concentrations of 13 µg/l and 9.5 µg/l, respectively and a concentration range of 1.5-1,410 µg/l (Main, 2006). In contrast, in a recent study the median DEHP levels of 30 human milk samples were lower (2.3 µg/l) (Zimmermann, 2012).

Phthalates are metabolized and excreted quickly and do not have the potential to accumulate in the body. Ingested phthalate di-esters are hydrolysed to corre-sponding monoesters, and further to secondary metabolites, which are ab-sorbed and oxidized in the body. To a large amount DEHP is excreted via the urine as glucuronide conjugate.

Within bio-monitoring studies DEHP and its metabolites (e.g., Mono-2-ethylhexyl phtahalate - MEHP) are determined in urine samples. These com-pounds are present in all studies conducted so far. Large scale studies have been performed for example in the U.S.A. or in Canada (see CDC, 2009; Sara-vanabhavan, 2013).

General population

Breast milk


January 2014 35

6.1.1 Exposure estimates of workers of EEE waste processing plants

The exposure estimation performed within this assessment is based on the as-sumptions and calculations provided in the chapter waste treatment and releas-es of DEHP.

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 (ECHA, 2013a) 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 DEHP, where exposure mainly occurs through dermal uptake and inhalation of dust (see chapter 5.3)

� shredding of cables containing DEHP, where exposure mainly occurs through dermal uptake and inhalation of dust (see chapter 5.3)

� recycling of WEEE containing DEHP, including formulation and use

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, 2010RCR- Risk Characterisation Ratio

Further selected input parameters: professional use of solid substance with high or medium dustiness, 8 hours activity (>than 4 hours), outdoors, no respiratory protection or gloves (dermal PPE - personal protective equipment). Further 100% of substance in the preparation (>25%) has been applied. The results were then corrected taking into account the calculated average DEHP content of EEE (Chapter 2.3) and information on transfer of DEHP to dusts from WEEE shredding (see Chapter 5.3.1). Thus the estimate of an average content of DEHP in the dust of WEEE shredders is 0.13% (see explanation Chapter 5.3.1)

ECETOC TRA

Limitations

RCR- Risk

Characterisation

Ratio


36 January 2014

and in dust of cable shredders is 5.3%45. In table 12 the results of the assess-ment are summarized. Concentrations are given in µg/m3.

Table 12: Results of the ECETOC-TRA model for exposure and risk of shredding

PROC WEEE shredders Cable shredders

Parameter

PROC

Process

category

Long-term

Inhalative

Exposure

Estimate (µg/m3)

Long-term

Dermal Exposure

Estimate

(µg/kg/day)

Long-term

Inhalative

Exposure

Estimate (µg/m3)

Long-term

Dermal Exposure

Estimate

(µg/kg/day)

conc. solid 24a 2100 2830 2100 2830

conc. solid 24b 3500 2830 3500 2830

conc. solid 24c 14000** 2830 14000** 2830

DEHP conc. 24a 2.73 3.68 111.30 149.91

DEHP conc. 24b 4.55 3.68 185.50 149.91

DEHP conc. 24c 18.20 3.68 742.00 149.91

DNEC/DNEL

880 1880 880 1880

*RCR 24a 0.003 0.002 0.13 0.08

*RCR 24b 0.005 0.002 0.21 0.08

*RCR 24c 0.021 0.002 0.84 0.08

*RCR: Risk Characterization 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. The total RCR, the sum of inhalative and dermal RCR is 0.21, 0.29 and 0.92 for the three defined exposure conditions (24a,b,c).

Inhalation exposure on the basis of monitoring data was estimated to be 0.051 mg/m3 (95th percentile; n=18) i.e. 51 µg/m3 respectively and dermal exposure on the basis of modelling was estimated to be 0.135 mg/kg bw/d (i.e. 135 µg/kg bw /day) (FoBiG, 2013). These data are within the range of the calculated sce-nario above. Whereas inhalation exposure is slightly overestimated (concentra-tions calculated for 24a are twice the 95 th percentile of measurements but with-in the same order of magnitude, calculated dermal exposure data are very close to the measurements (149 versus 135 µg/kg BW/day). The monitoring data provided further evidence that a worker can be exposed to DEHP concentra-tions above the DNEL during specific tasks. The overall RCR calculated by FoBig is 0.13, which is close to the scenario with the lowest calculated RCR of 0.2.

Concluding, individual measurements (three sites, 16 personal shift average samples) demonstrate that the used method delivers values which are reliable.

4510,000 t / 9,400,000 t / 0,02

Monitoring data

Plastic recyclers

Europe


January 2014 37

Taking into consideration that other hazardous substances are present in the WEEE shredders risk for shredder workers cannot be excluded.

6.1.1.2 Exposure estimates: Recycling: formulation

In the frame of the ROHS review project the ECETOC TRA tool was used to provide estimates for human exposure for recycling processes.

Several process categories relevant for formulation (PROC1, PROC 2, (closed process indoors) PROC3, PROC4, PROC 8a-b (transfer processes), PROC 14 (production of preparations and articles) all indoors were selected. A content of 5-25% of DEHP in the preparation was chosen as input parameter46.

It is assumed that the substance is dispersed in a solid matrix. Due to the lim-ited information on the actual practices in PVC recycling different scenarios were calculated. The first scenario describes appropriate exposure conditions, low dustiness, taking into account LEV (local extract ventilation) for PROC 2, 3,4,8,14,21 and gloves (APF5) for all processes. The table below shows that there is no risk expected under these conditions.

The scenario calculated below takes LEV into consideration.

46 out of the options: <1%, 1-25%, >25%


38 January 2014

Table 13: Results of the ECETOC-TRA model for long term exposure to DEHP : rec.form

PROCESS

Long-term

Inhalative

Exposure

Estimate

(mg/m3)

Long-term

Dermal Ex-

posure Es-

timate

(mg/kg/day)

Risk Characteri-

sation Ratio -

Long-term In-

halation

Risk Characteri-

sation Ratio -

Long-term

Dermal

Risk Characteri-

sation Ratio -

Long-term Total

Exposure

PROC 1 0,006 0,004 0,001 0,002 0,003

PROC 2 0,006 0,165 0,001 0,088 0,089

PROC 2 0,001 0,016 0,000 0,009 0,009

PROC 3 0,006 0,008 0,001 0,004 0,005

PROC 3 0,006 0,008 0,001 0,004 0,005

PROC 3 0,060 0,082 0,010 0,044 0,054

PROC 4 0,300 0,823 0,049 0,438 0,486

PROC 8a 0,030 0,165 0,005 0,088 0,092

PROC 8b 0,003 0,082 0,000 0,044 0,044

PROC 14 0,006 0,041 0,001 0,022 0,023

However, as using protective equipment is not always the case, table 14 shows the results assuming the same scenario as above, but without using gloves by workers. Dermal and total risk ratios are considerably higher compared to the first scenario. For PROC 4 they are above 1.

Table 14: ECETOC TRA calculation recycling formulation: without gloves

PROCESS

Long-term

Inhalative

Exposure

Estimate

(mg/m3)

Long-term

Dermal Ex-

posure Es-

timate

(mg/kg/day)

Risk Characteri-

sation Ratio -

Long-term In-

halation

Risk Characteri-

sation Ratio -

Long-term

Dermal

Risk Characteri-

sation Ratio -

Long-term Total

Exposure

PROC 1 0,006 0,021 0,001 0,011 0,012

PROC 2 0,006 0,823 0,001 0,438 0,439

PROC 2 0,001 0,082 0,000 0,044 0,044

PROC 3 0,006 0,041 0,001 0,022 0,023

PROC 3 0,006 0,041 0,001 0,022 0,023

PROC 3 0,060 0,411 0,010 0,219 0,229

PROC 4 0,300 4,114 0,049 2,188 2,237

PROC 8a 0,030 0,823 0,005 0,438 0,443

PROC 8b 0,003 0,411 0,000 0,219 0,219

PROC 14 0,006 0,206 0,001 0,109 0,110


January 2014 39

To calculate a worst case scenario it has been assumed that all processes are performed indoors with high dustiness, without LEV and without PP (gloves). The results are depicted in table 15. It is clearly visible that under inappropriate working conditions there is a risk for workers (numbers in bold). For PROC 4 the total RCR rises up to almost 10.


40 January 2014

Table 15: Results of the ECETOC-TRA model for long term exposure to DEHP,

recycling without LEV and PP

PROCESS

Long-term

Inhalative

Exposure

Estimate

(mg/m3)

Long-term

Dermal Ex-

posure Es-

timate

(mg/kg/day)

Risk Char-

acterisa-

tion Ratio

- Long-

term In-

halation

Risk Charac-

terisation Ra-

tio -Long-

term Dermal

Risk Character-

isation Ratio -

Long-term To-

tal Exposure

PROC 1 0,006 0,021 0,00 0,01 0,01

PROC 2 0,600 0,823 0,10 0,44 0,54

PROC 2 0,600 0,823 0,10 0,44 0,54

PROC 3 0,600 0,411 0,10 0,22 0,32

PROC 3 0,600 0,411 0,10 0,22 0,32

PROC 3 0,600 0,411 0,10 0,22 0,32

PROC 4 15,000 4,114 2,44 2,19 4,62

PROC 8a 30,000 8,229 4,87 4,38 9,25

PROC 8b 15,000 8,229 2,44 4,38 6,81

PROC 14 6,000 2,057 0,97 1,09 2,07

6.1.1.3 Exposure estimates: Recycling: use

Several process categories relevant for industrial use of recycled material (PROC 2, (closed process indoors) PROC3, PROC4, PROC 6 (calendaring) PROC 8a-b (transfer processes), PROC 14 (production of preparations and ar-ticles) and PROC 21(low energy manipulation of articles: cutting, welding, glu-ing) all indoors were selected. A content of 5-25% of DEHP in the preparation was used as input parameter. It is expected that the substance is dispersed in a solid matrix. Due to the limited information on the actual practices in PVC recy-cling different scenarios were calculated. The first scenario describes appropri-ate exposure conditions, low dustiness, taking into account LEV (local extract ventilation) for all processes, but without PP (gloves). PP would improve the RCRs, what would be preferable for PROC 6 (Calendaring). Table 16 below gives an overview on estimated concentrations and RCRs.

The scenario calculated below takes LEV into consideration


January 2014 41

Table 16: Results of the ECETOC-TRA model for long term exposure to DEHP : recy-

cling use with LEV, but no PP

Process

Long-term Inhalative Exposure Estimate (mg/m3)

Long-term Dermal

Exposure Estimate

(mg/kg/day)

RCR - Long-term

Inhalation

RCR -Long-term

Dermal

RCR - Long-term Total Exposure

PROC 2 0,001 0,08 0,000 0,04 0,04

PROC 3 0,01 0,04 0,001 0,02 0,02

PROC 4 0,03 0,41 0,005 0,22 0,22

PROC 6 0,01 1,65 0,001 0,88 0,88

PROC 8a 0,03 0,82 0,005 0,44 0,44

PROC 8b 0,00 0,41 0,000 0,22 0,22

PROC 14 0,01 0,21 0,001 0,11 0,11

PROC 21 0,06 0,17 0,01 0,09 0,10

Assuming that the dustiness is low but no LEV and PP is present the following concentrations and RCRs were estimated.

Table 17: Results of the ECETOC-TRA model for long term exposure to DEHP: rec. use

Process

Long-term Inhalative Exposure Estimate (mg/m3)

Long-term Dermal

Exposure Estimate

(mg/kg/day)

RCR - Long-term

Inhalation

RCR -Long-term

Dermal

RCR - Long-term Total Exposure

PROC 2 0,01 0,82 0,00 0,44 0,44

PROC 3 0,06 0,41 0,01 0,22 0,23

PROC 4 0,30 4,11 0,05 2,19 2,24

PROC 6 0,06 16,46 0,01 8,75 8,76

PROC 8a 0,30 8,23 0,05 4,38 4,43

PROC 8b 0,06 8,23 0,01 4,38 4,39

PROC 14 0,06 2,06 0,01 1,09 1,10

PROC 21 0,60 1,70 0,10 0,90 1,00

It is stated in the RAR that for the scenario of industrial end-use of products containing DEHP relatively high work temperatures, aerosol generation and considerable skin contact might occur. There is some uncertainty to which ex-tent these conditions are covered by the ECETOC TRA model.

Information about exposure conditions in recycling (formulation and use) pro-cesses is not publically available so far. The European recycling industry has submitted a request for authorisation for recycled soft PVC containing DEHP in accordance to REACH. The envisaged authorisation covers the use of recyclate pellets/regranulate in compounding and in converting into articles (through pro-cesses such as extrusion, compression and injection moulding etc..). The au-thorisation dossiers will be assessed by the European Chemicals Agency Risk

Authorisation

request for soft PVC

containing DEHP


42 January 2014

Assessment Committee (RAC) and the Socio Economic Assessment Commit-tee (SEAC) and their opinion is expected by September 2014.

6.1.2 Monitoring of human exposure at EEE waste processing plants

Several studies indicate that workers of industries, where DEHP is manufac-tured or used, have higher DEHP and/or DEHP metabolites concentration com-pared to controls (ECB, 2008). A recent study reports biological monitoring data in six French factories. Clear evidence of occupational exposure of workers in the factories was documented. Urinary levels were significantly higher in the exposed versus unexposed workers and significantly higher in the post-shift ex-cretion compared to the pre-shift urinary concentrations (Gaudin et al. 2011).

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 treatment plants in Europe in the peer-reviewed literature.

The European Plastic Converters submitted dossiers for authorisation of soft PVC containing DEHP under REACH. These dossiers cover the use of recy-clate pellets/regranulate in compounding and in converting into articles (through processes such as extrusion, compression and injection moulding etc..) to the European Chemicals Agency. These dossiers contain human biomonitoring da-ta according to EuPc (communication during stakeholder consultation). The au-thorisation dossiers will be assessed by the European Chemicals Agency Risk Assessment Committee (RAC) and the Socio Economic Assessment Commit-tee (SEAC); their opinion is expected by September 2014.

The European Plastic Recyclers provided data on three shredder sites in Eu-rope: a total of 16 personal shift average samples derived from personal sam-pling measurements (of seven workers) at 3 sites. DEHP was analysed in in-halable and respirable durst. The maximum shift average measured was 0.18 mg DEHP/m3, with peaks at specific tasks of 1.3 mg DEHP/m3, clearly exceed-ing the DNEC of 0.88 mg DEHP/m3 derived by the RAC (Risk Assessment Committee of ECHA). However all other measurements were well below the DNEC and those specific tasks were defined as worst case scenario at one site handling the final product (separated and milled PVC with handling virgin DEHP in the same workroom (FoBig, 2013)).

It has to be considered, that the sites, which participated in this study voluntari-ly, may not be a representative sample for all European sites. Photographs pro-vided demonstrate good personal protective measures and working conditions.

Finally the monitoring data support the estimates provided in the previous chap-ter (6.1.1.1); concentrations are within the same range, suggesting that direct handling and transfer processes lead to higher exposure concentrations.

One recently published human study could demonstrate that plastic waste recy-cling plant workers had statistically higher levels of urinary 8-hydroxy-2-deoxy-guanosine levels, a marker of oxidative stress to DNA and possible risk for can-cer. A multivariate analysis of data revealed that working history has been a risk

General monitoring

of industries using

DEHP

Monitoring WEEE

treatment

Authorisation

process soft PVC

containing DEHP

EuPC Monitoring

Monitoring data,

third countries


January 2014 43

factor for higher levels of the marker. The study was carried out with 181 work-ers and 160 farmers in Hunan Province, China. In the study also the DEHP lev-els were to a great extent higher in the environment (soil and water) at the recy-cling sites than at reference site (see Table 32). The authors relate the ob-served adverse outcome on DNA marker to DEHP exposure of workers (Wang et al., 2011).

However, it can be reasonable assumed, that these workers are co-exposed to various kinds of substances present in plastic waste and therefore a conclusion that these observed adverse outcomes are only related to DEHP exposure is hard to draw. To date, no further study confirms the outcome of the aforemen-tioned study.


44 January 2014

6.2 Environmental exposure

To define background levels in industrial, urbanized and rural regions numerous monitoring studies have been conducted in different parts of the world. The available monitoring data have been summarised within the EU RAR (ECB, 2008). Higher exposure levels were detected in samples of urban and/or indus-trial areas.

Releases of DEHP to the environment occur over the whole life-cycle as a re-sult of production, transport, formulation, processing of PVC and non-polymers. Furthermore, plasticisers are not chemically bound to the matrix. Thus, DEHP will to some extent be released from articles during its use and after its final dis-posal.

In air samples DEHP has been found in the gas, solid (particles) and water (rain water) phase. The concentrations ranged between 0.3 to 300 ng/m3. Higher values have been measured in industrial areas.

The reported levels of DEHP range between < 0.1 up to 21 µg/l in river waters. In marine surface waters the level was below 0.1 µg/l in samples without known contamination source. Samples taken from point source areas with known DEHP sources were higher contaminated.

Majority of monitoring studies have been carried with agricultural soil. Very high levels were detected in a study in which agricultural soil samples were taken from a field amended for 25 year with high amount of sewage treatment plant (STP) sludge (Vikelsøe et al., 1999). Study outcome demonstrates that DEHP is very slowly degraded, since high levels were detected after cessation of sewage and fertiliser application. Furthermore, high exposure levels were found in deeper soil layers.

DEHP concentrations of surface sediments from river and lakes are in the range of 0.04 to 21 mg/kg dwt. Higher levels have been observed in areas close to processing sites.

Table 18: Monitoring levels of DEHP in different environmental compartments (Source:

ECB, 2008)

Compartment Concentration levels

Air 0.3-300 ng/m3

Water River water Marine surface water

< 0.1 up to 21 µg/l1 < 0.1 µg/l

Soil

Agricultural soil Agricultural soil (application of STP sludge) Soil (without known DEHP source)

0.08-2.7 mg/kg dw

0.12 up to 3,4003

< 0,025 and 0.17 mg/kg dwt

Sediment 0.04 and 21 mg/kg dwt2

1 industrial and highly urbanized sites having the highest levels

2 levels above have been detected i polluted regions;

3 very high concentrations have been detected in agricultural soil in which high amounts of sewage

sludge (17 tonnes dwt/ha . year) have been applied for long time period (25 yrs); STP; sewage

treatment plant

Air samples

Water samples

Soil

Sediment


January 2014 45

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 scenarios which have been defined as most relevant: shredding, cable shred-ding and recycling formulation and recycling use.

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 19.

Table 19: 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 with 10 day window

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

6.2.1.1 Exposure estimates: Shredding

Overall Shredding

Additional input parameters for the shredder scenario are given in table 20. As a worst case scenario in total 0.294 kg47 were taken as local emissions to the air as presented in table in chapter 5.3.3. 3,750 t/a (table 9) as total input of DEHP in WEEE shredders was taken as production volume.

47 292 +2,1 g

EUSES

Limitations

EUSES Input

parameters


46 January 2014

Table 20: Selected EUSES input parameters: overall shredding

Descriptor input

Production volume 3,750

Fraction of the EU production volume in the region 10

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

Local emissions to air during episode 0.294 kg (max.)

Local STP input Bypass STP

The derived local PECs are given in Table 21 below.

Table 21: Results of environmental assessment using EUSES: overall shredding

DEHP concentrations and PECs result unit

Concentration in air during emission episode 81.70 ng/m3

Annual average concentration in air, 100 m from point source 81.70 ng/m3

Local PEC in surface water during emission episode (dissolved) 42.90 ng/l

Annual average local PEC in surface water (dissolved) 42.90 ng/l

Local PEC in fresh-water sediment during emission episode 49.50 µg/kg wwt

Local PEC in seawater during emission episode (dissolved) 7.84 ng/l

Annual average local PEC in seawater (dissolved) 7.84 ng/l

Local PEC in marine sediment during emission episode 9.05 µg/kg wwt

Local PEC in agric. soil (total) averaged over 30 days 363 µg/kg wwt


Local PEC in grassland (total) averaged over 180 days 384 µg/kg wwt

Local PEC in groundwater under agricultural soil 387 ng/l

Further the risk of secondary poisoning has been evaluated; the calculated con-centrations in fish are summarized in Table 22.

Table 22: Results of PECs for secondary poisoning: overall shredding

DEHP concentrations and secondary poisoning result unit

Concentration in fish for secondary poisoning (freshwater) 36 µg/kg wwt

Concentration in fish for secondary poisoning (marine) 6.58 µg/kg wwt

Concentration in fish-eating marine top-predators 6.58 µg/kg wwt

Concentration in earthworms from agricultural soil 98.3 mg/kg

Exposure estimates: Cable Shredding

Additional input parameters for the cable shredder scenario are given in table 23. As a worst case scenario in total 1,54 kg were taken as local emissions to the air as presented in table 12 chapter 5.3.3. 3,520 t/a as total input of DEHP in WEEE shredders was taken as production volume.

Overall Shredding:

Input parameters

Shredding: PECs

Shredding: PECs

secondary

poisoning


January 2014 47

Table 23: Selected EUSES input parameters: cable shredding

Descriptor input

Production volume 3,520

Fraction of the EU production volume in the region 10

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

Local emissions to air during episode 1.7 36 kg (max.)

Local STP input Bypass STP


Table 24: Results of environmental assessment using EUSES: cable shredding


Annual local PEC 0,28 µg/m3

Local PEC in surface water during emission episode (dissolved) 40.30 ng/l

Annual average local PEC in surface water (dissolved) 40.30 ng/l

Local PEC in fresh-water sediment during emission episode 46.50 µg/kg wwt



Local PEC in marine sediment during emission episode 8.49 µg/kg wwt



Local PEC in grassland (total) averaged over 180 days 457 µg/kg wwt

Local PEC in groundwater under agricultural soil 0.41 µg/l


Table 25: Results of PECs for secondary poisoning: cable shredding

DEHP concentrations and secondary poisoning result unit

Concentration in fish for secondary poisoning (freshwater) 33.8 µg/kg wwt



Concentration in earthworms from agricultural soil 101 mg/kg

Cable Shredding:

Input parameters

Cable Shredding:

PECs

Shredding:

PECs secondary

poisoning


48 January 2014

6.2.1.2 Exposure estimates: Recycling

Table 26: Additional input parameters for the recycling formulation scenario

Descriptor input

Production volume 1173

Fraction of tonnage released to air 0.5

Fraction of tonnage released to waste water 0.5

Fraction of tonnage released to surface water 0

Local STP input Use STP


Table 27: Results of environmental assessment using EUSES: recycling formulation




Concentration in surface water during emission episode (dissolved) 0.49 µg/l

Annual average concentration in surface water (dissolved) 0.30 µg/l

Local PEC in surface water during emission episode (dissolved) 0.50 µg/l

Annual average local PEC in surface water (dissolved) 0.31 µg/l

Local PEC in fresh-water sediment during emission episode 0.58 mg/kgwwt

Concentration in seawater during emission episode (dissolved) 49.40 ng/l

Annual average concentration in seawater (dissolved) 29.80 ng/l



Local PEC in marine sediment during emission episode 0.06 mg/kgwwt

Local PEC in agric. soil (total) averaged over 30 days 1.03 mg/kgwwt

Local PEC in agric. soil (total) averaged over 180 days 1.02 mg/kgwwt

Local PEC in grassland (total) averaged over 180 days 0.40 mg/kgwwt

Local PEC in groundwater under agricultural soil 1.09 µg/l


Table 28: Results of PECs for secondary poisoning: recycling formulation

DEHP concentrations secondary poisoning result unit

Concentration in fish for secondary poisoning (freshwater) 131 µg/kg wwt



Concentration in earthworms from agricultural soil 187 mg/kg

Recycling: input

formulation

Recycling:

PECs formulation

Recycling:

formulation:

Secondary

poisoning


January 2014 49

The scenario: recycling –use is described in the following:

Table 29: Additional input parameters for the recycling use scenario

Descriptor input

Fraction of tonnage released to air 0.5

Fraction of tonnage released to waste water 0.5

Fraction of tonnage released to surface water 0

Local STP input Use STP


Table 30: Results of environmental assessment using EUSES: recycling use




Concentration in surface water during emission episode (dis-solved)

166 ng/l

Annual average concentration in surface water (dissolved) 100 ng/l

Local PEC in surface water during emission episode (dissolved) 174 ng/l

Annual average local PEC in surface water (dissolved) 108 ng/l

Local PEC in fresh-water sediment during emission episode 201 µg/kgwwt

Concentration in seawater during emission episode (dissolved) 16.60 ng/l

Annual average concentration in seawater (dissolved) 10 ng/l



Local PEC in marine sediment during emission episode 20.10 µg/kgwwt

Local PEC in agric. soil (total) averaged over 30 days 350 µg/kgwwt

Local PEC in agric. soil (total) averaged over 180 days 347 µg/kgwwt

Local PEC in grassland (total) averaged over 180 days 138 µg/kgwwt

Local PEC in groundwater under agricultural soil 370 µg/l


Table 31: Results of PECs for secondary poisoning: recycling use

DEHP concentrations secondary poisoning result unit

Concentration in fish for secondary poisoning (freshwater) 48.20 µg/kg wwt



Concentration in earthworms from agricultural soil 64.4 mg/kg

6.2.2 Monitoring data: WEEE treatment sites/locations

No monitoring studies near WEEE treatment plants in Europe are available.

Recycling: use

input parameters

Recycling:

use PECs

Recycling:

use Secondary

poisoning


50 January 2014

Only few environmental monitoring studies are available. All of them were car-ried out in China.

Measured concentrations in air samples of e-waste dismantling sites are in the range between 164.87 to 191.82 ng/m3. DEHP exposure levels at e-waste dis-mantling sites were 2-fold higher compared to concentrations detected at con-trol areas (80.62 to 97.68 ng/m3) (Gu et al., 2010).

In the study of Wang et al. (2011) water samples have been analysed for the presence of DEHP at plastic waste recycling sites (sampling year 2008).

Mean DEHP exposure level in drinking water was 14.2 µg/l. The concentrations of DEHP in pond water and in industry water were 135.68 µg/l and 42.43 µg/l, respectively. Compared to the reference site the levels in well water were 18-fold and in pond water even 367-fold higher compared to the levels detected at reference site.

Wang et al. (2011) analysed DEHP in cultivated soil at plastic waste recycling sites. The mean concentration in the samples was 13.07 mg/kg. Mean DEHP concentration in soil was 16-fold higher compared to the reference site.

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 are in the range of 12.5 to 46.6 mg/kg indicating very high exposure levels. DEHP, DBP and DEP were the major phthalates accounting for 94% of total phthalates.

In the study of Ma et al. (2012) carried out in east China the PAE concentration levels of six target pollutants (DMP, DEP, DnBP, BBP, DEHP, DnOP) in soils ranged from 0.31 to 2.39 mg/kg. The total PAEs concentarion levels are lower compared to the aforementioned study. The most abundant PAE in soil is DEHP (approximately 80-90%).

Furthermore, results of the examination of Ma et al. (2012) indicate that PAEs concentration levels in soil samples are dependent on the kind of vegetables cultivated on the soil. It has been demonstrated that PAEs are removed by plants. The removal rate is in the range between 1.24 to 88% and is depended on the plant variety and the cultivation method.

The PAEs concentrations in the cultivated plant samples ranged from 1.81 to 5.60 mg/kg dw (Ma et al., 2012). 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.

Results from environmental monitoring studies are only available from China. DEHP concentration levels measured in environmental compartments in e-waste areas are higher than at reference site or sites without known DEHP source.

An overview of the environmental monitoring studies carried out in China is de-picted in Table 32.

Air

Water

Soil

Plant

Conclusion

RO

HS

Annex II D

ossier DE

HP

January 2014 51

Table 32: Environmental monitoring data from sites near to e-waste plants

Samples DEHP concentration Country Sampling area Remarks Reference

Air

Ambient fine particles (PM 2,5)

exposed site (summer): 164.87 ng/m3 (mean) exposed site (winter): 191.82 ng/m3 (mean) reference site (summer): 80.62 ng/m3 (mean) reference site (winter): 97.68 ng/m3 (mean)

China E-waste dismantling area

The mean concentration of DEHP is about 2 fold higher in the exposed site vs. reference site.

Gu et al., 2010

Water

Well water exposed site: 0.31-87.69 µg/l (mean: 14.20 µg/l)

reference site: 0.27-2.26 µg/l (mean: 0.79 µg/l)

China Plastic waste recycling site

Well water might be used as drinking water. Mean levels were significant higher in the recycling than at reference site. The levels are 18 fold higher. Sampling year was 2008.

Wang et al., 2011

Pond water exposed site: 0.31-429.89µg/l (mean: 135.68 µg/l)

reference site: 0.23-0.47 µg/l (mean: 0.37 µg/l)


Mean levels were significant higher in the recycling than at reference site. The levels are 367-fold higher. Sampling year was 2008.

Wang et al., 2011

Industry water exposed site: 0.36-161.85 µg/l (mean: 42.43 µg/l)

reference site: -


Mean levels were significant higher in the recycling than at reference site. Sampling year was 2008.

Wang et al., 2011

Soil

Agricultural soil exposed site: 0.85-37.23 mg/kg (mean: 13.07 mg/kg) reference site: n.d. – 5.81 mg/kg (mean: 0.81mg/kg)


Mean levels are 16 fold higher than at the reference site. Sampling year was 2008.

Wang et al., 2011

Soil exposed site: 0.31-2.39 mg/kg* China E-waste recycling site Depending on kind of vegetables cultured on soils the phthalic acid ester varies.

Ma et al., 2012

Soil exposed site: 12.56 to 46.67 mg/kg** China E waste Severely contamination of soils Liu et al., 2010

Plants

Various kinds of vegetables

exposed site: 1.81-5.177 mg/kg dw* China E-waste recycling site Higher concentrations have been detected in root or stem vegetables.

Ma et al., 2012

* concentration range of target phthalic acid esters (DMP, DEP; DnBP, BBP, DEHP, DnOP), approximately 80-90% of PAEs in soil samples is DEHP; ** total phthalic acid esters (PAEs)


52 January 2014

7 IMPACTS ON WASTE MANAGEMENT

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

According to REACH, Annex XIV, the placing on the market of DEHP for a use or use by himself by a manufacturer, importer or downstream user is not al-lowed unless an authorization is granted for a particular use. Furthermore ac-cording to Annex XVII to REACH DEHP is restricted in toys and childcare arti-cles. Thus it is expected that recycling possibilities for PVC will be reduced due to the presence of DEHP in WEEE plastics.

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 DEHP would stay in the recycling loop for many cycles. A closed loop recycling of PVC from cables and wires is technically not possible due to metal contaminations.

Wastes with a DEHP content of 0.5% are considered hazardous in accordance to the European list of waste (fulfillment of criterion H10, reprotoxic48

).

Considering a plasticiser-content in PVC of 20-60%49, and a 20% share of DEHP within used plasticisers50 the DEHP-concentration in PVC in WEEE ca-bles is as a minimum 4%51. Assuming a 40%-share of PVC in cables52 it can be seen that both, cables as such and any non-metal fractions resulting from shredding of cables, would have to be classified as hazardous waste. Based on 66,000 tonnes of cables from WEEE being mechanically treated and a non-metal fraction of 44,000 tonnes52 a generation of min. 110,000 t/a53 of hazard-ous wastes arise54.

7.2 Risks estimation for workers and neighbouring residents

Within the RAR following assumption on risk of workers have been drawn:

For the scenario of industrial end-use of products containing DEHP, it is as-sumed that relatively high work temperatures, aerosol generation and consider-able skin contact occur.

There is concern for the testicular effects, fertility, toxicity to kidneys, on repeat-ed exposure, and developmental toxicity for workers as a consequence of inha-

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

classified as R60, R61 at a total concentration ≥ 0,5 % mean that H10 is fulfilled 49 IPTS, 2013 50 DEPA, 2010 51 Minimum DEHP content in PVC: 20% of 20% �4% 52 The material composition of cables: two thirds of the cable are non-metal fraction, 60% of that

fraction is PVC (Bipro, 2002, Umweltbundesamt, 2008) 53 66,000 t + 44,000 t 54 The fact that soft PVC waste is in general not handled as hazardous waste although a criterion

for hazardous waste according to 2000/532/EC are fulfilled is not further considered

Recycling

possibilities

DEHP remaining in

the recycling loop

Generation of

hazardous waste


January 2014 53

lation and dermal exposure. There is no concern for the acute toxicity, irritation and sensitising effects, carcinogenicity, and mutagenicity.

Conclusion (iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account.

There is still few quantitative and qualitative information available on technical control measures and personal protective equipment used during production and processing. The exposure estimation using the ECETOC TRA tool shows very clearly that with adequate ventilation (LEV) and personal protection measures such as gloves risks can be minimized, whereas under inappropriate conditions risks for workers are expected. Also for workers and neighbouring residents in third countries a risk can be expected.

7.3 Risks estimation for the environment

In order to assess if the DEHP exposure of the herein described scenarios pose a risk to the environment the PECs were compared with the derived PNEC. In general if the ratio of the predicted environmental concentration to the concen-tration 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 33 the PNEC and the PECs of the different scenarios are depicted.

Table 33: PEC/PNEC ratios for the different scenarios

PECs PNECs PECs

Compartment shredding cable shredding

rec-form rec-use

Aquatic compartment

EQSwater* (µg/l) 1.3 0.042 0.043 0.49 0.1

freshwater sediment (mg/kg)

>100 0.05 0.05 0.06 0.2

Terrestrial compartment

soil (mg/kg) >13 0.3 0.47 1.02 0,06

Secondary poisoning

fish freshwater mg/kg 16 0,03 0,03 0,1 0.05

birds (mg/kg) 17 98.3 103 187 64.4

Mammalian (mg/kg) 3.3 98.3 103 187 64.4

* EQS: Environmental Quality Standard: as priority pollutant of the European Water framework

directive an EQS of 1.3µg/l has been derived; No PNEC has been derived within the RAR;

PEC /PNEC ratios exceeding 1:

Secondary poisioning PNEC PEC/PNEC

birds (mg/kg) 17 5.78 6.06 11.00 5.78

Mammalian (mg/kg) 3.3 29.79 31.21 56.67 29.79

According to the estimated exposure conditions based on the EUSES model for waste treatment, with specific input data there is no risk for sediment and soil.

PECs


54 January 2014

No PNEC for the aquatic compound had been derived. Regarding secondary poisoning, however there is a risk for mammalians and birds, which prey on earthworms. There might be limitations of this method due to above described shortcomings and an overestimation for the estimated secondary poisoning val-ue for earthworms from agricultural soil but it strongly suggests a risk. Also in the RAR for birds eating mussels and for mammalians eating earthworms the conclusion (iii) had been reached: There is a need for limiting the risks; risk re-duction measures which are already applied shall be taken into account. This conclusion applied to the processing of polymers containing DEHP.


January 2014 55

8 ALTERNATIVES

8.1 Availability of alternatives

Several alternative assessments for DEHP, DBP and BBP were conducted re-cently (for details see Lowell Center, 2011; Maag et al., 2010; DEPA, 2011, COWI, 2009). Potential alternatives, possible hazardous adverse effects and technical properties of these alternatives are comprehensively summarised in these reports.

Beside other supposed less hazardous phthalate compounds, non-phthalate al-ternatives (e.g., Di-isononyl-cyclo-hexane-1,2dicarboxylate – DINCH; Alkyl-sulphonic phenylester - ASE), other petroleum based materials and bio-based plastics are listed. For some alternatives there is a lack of data regarding the hazardous potential to human health and environment.

The use of DEHP has stronglgeneraly declined within the last decades, indicat-ing that suitable and technically feasible alternatives are available (COWI, 2009).

According to DEPA (2010) the use of DEHP is not deemed necessary in electri-cal and electronic equipment (EEE). They further state that it cannot be ruled out completely that some niche productions for specialised purposes in some EEE may have difficulties in substituting DEHP, although no such evidence has been encountered.

Today, the most used alternatives in EEE are Di-isononyl phthalate (DINP) and di-disodecyl phthalate (DIDP). According to one manufacturer, DIDP constitutes about 80% of the current plasticiser consumption for cables in the EU (DEPA, 2011), indicating that for cables and wires DEHP is used to a minor extent.

Other non-phthalate plasticisers exist, e.g. ASE (Alkylsulphonic phenylester) and DINCH (Di-isononyl-cyclohexane-1,2-dicarboxylate) (DEPA, 2010). ASE and DINCH are used for sensitive applications such as toys, medical care arti-cles and for food contact materials.

No detailed data about the market share of used alternative plasticizers in EEEs is present.

8.2 Hazardous properties of alternatives

Table 34 summarizes the most relevant concerns of selected alternatives used in the EEE sector55.

Di-isononyl phthalate (DINP) was assessed within the European Risk as-sessment series (ECB, 2003a). Based on the current legislation the use of DINP in toys and childcare articles which can be placed in the mouth is re-stricted. This measure was re-evaluated in the year 2013 by ECHA (ECHA, 2013) and no alterations of existing restriction of DINP and DIDP are foreseen related to entry 52 in Annex XVII to REACH.

55 for further details on alternatives see Maag et al., 2010, COWI, 2009

Alternative

assessments

DEHP in EEE

Examples of

alternatives

Phthalate

compounds used

as alternatives


56 January 2014

DINP possess hepatotoxic effects. There are some disagreements related to its anti-androgenic potential. Even though DINP has shown anti-androgenic ef-fects, these are seen at much higher concentrations compared to DEHP, DBP and BBP (DEPA, 2011). Anti-androgenic effects were also recently confirmed by ECHA (ECHA, 2013b).The most sensitive endpoint is the hepatotoxic effect of DINP.

Di-disodecyl phthalate (DIDP) was assessed within the European Risk as-sessment series (ECB, 2003b). Based on the current legislation the use of DINP in toys and child care articles which might be placed in the mouth is re-stricted. This measure was re-evaluated in the year 2013 by ECHA (ECHA, 2013) and no alteration of existing restriction of DINP and DIDP foreseen relat-ed to entry 52 in Annex XVII to REACH.

Alkylsulphonic phenylester (ASE): ASE possess low acute toxicity and no ir-ritating, sensitising 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). A developmental toxicity study did not in-dicate 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 conclusion might not be drawn.

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 o 107.1 mg/kg bw/ day.

DINCH and ASE might be appropriate alternatives for DEHP regarding their tox-ic profile.

According to EchoStar DINP, is a substitute for DEHP based on current practice (comment, stakeholder consultation, October 2013).

Non-phthalate

compounds


January 2014 57

Table 34: Summary of most relevant concerns of alternatives for DEHP used in the EEE

sector (for details see ECHA, 2013; DEPA, 2011)

Substance Name CAS Number Human health concerns Environmental health concerns

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

Phthalates

1,2-benzene-dicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich/

di-“isononyl” phthalate

(DINP)

68515-48-0/

28553-12-0

Significant in-creases of inci-dence of spon-giosis hepatis together with other signs of hepatotoxicity in rats. Disagreement regarding relevance of spongiosis hepatits in humans.

endocrine disruptor**

No toxic effects towards fish, invertebrates or algae.

no HC; SC: Aquatic Acute 1, Repr. 2, Skin Irrit. 2; Eye Irrit. 2 (for CAS 68515-48-0)

no HC; SC: Aquatic Acute 1, Aquatic Chronic 1, Acute Tox 4 (for CAS 28553-12-0)

1,2-Benzene-dicarboxylic acid, di-C9-11- branched alkyl esters, C10-rich/

di-“isodecyl” phthalate

(DIDP)

68515-49-1/

26761-40-0

Significant increases of incidence of spongiosis hepatis together with other signs of hepatotoxicity in rats. Disagreement regarding relevance of spongiosis hepatits in humans.

Reprotoxic effects. Decrease in survival incidences (NOAEL: 33 mg/kg bw/day)

Low bioaccumulation properties.

no HC; SC: Skin Irrit. 2; Eye Irrit. 2 (for CAS: 68515-49-1)

no HC; SC: Aquatic Acute 1, Aquatic Chronic 1, Aquatic Chronic 2, Skin Irrit. 2; Eye Irrit. 2 (for CAS 26761-40-0)

Non-phthalates

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).

Critical endpoint has been the kidney toxicity (NOAEL 107.1 mg/kg bw/day)

Not readily bio-degradable. Data indicate moderate bioaccumulation potential.

no HC; no SC

Alkylsulphonic phenylester (ASE)

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

Not readily biodegradable and potential for bioaccumulation Data on aquatic organism indicate low toxicity.

no HC; SC: aquatic chronic 4

* 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)

** According to ECHA, 2013b reveals DINP anti-androgenic properties

The DNELs for DINP and DIDP deduced by ECHA (ECHA, 2013), as well as the preliminary DNELs deduced by COWI 2009 are summarized in Table 35.

For comparison the DNELs for DEHP, which were estimated recently by the RAC (RAC, 2013) are also listed in Table 14.

The DNELs for DEHP are lower compared to possible used alternatives within the EEE sector.


58 January 2014

Table 35: Deduced DNELs for general population for DINP, DIDP, DINCH, ASE and DEHP

(ECHA, 2013b; COWI, 2009)

Phthalate Critical endpoint DNEL oral (mg/kg) General population

DNEC inhalative (mg/m3)

General population DNEL dermal (mg/kg) General popu-lation

DINP1 Liver toxicity 0.075 0.35 1.88

DIDP1 Liver toxicity 0.075 0.35 1.88

ASE2 Liver toxicity 0.055 0.78 n.d.

DINCH2 Kidney toxicity 0.53 1.87 n.d.

DEHP3 Testicular toxicity 0.034 0.16 1.67

1 source ECHA, 2013b,

2 preliminary DNELs (COWI), 2009,

3 RAC, 2013

8.3 Conclusion on alternatives

Detailed assessments on possible alternatives were carried out recently (Maag et al.; 2010, COWI; 2009, DEPA, 2011).

Beside the hazard profile also the use and technical feasibility of possible sub-stitutes were determined. The mentioned pieces of work come to the conclusion that the use of less harmful alternatives to DEHP is possible and already in place. The use of DEHP in EEE is not deemed essential, however, some niche application cannot be ruled out.


January 2014 59

9 DESCRIPTION OF SOCIO-ECONOMIC IMPACTS

9.1 Approach and assumptions

The socio-economic analysis is based on two scenarios:

� In Scenario A the present legislation is not changed and DEHP may continue to be used in EEE (no ban of DEHP).

� In Scenario B the use of DEHP in EEE is banned. DEHP is replaced in PVC (and other plastics) by the plasticiser DINCH (Di-isononyl-cyclohexane-1,2dicarboxylate). DINCH may be the least expensive phthalate-substitute available.

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:

� The selection of DEHP or of DINCH as its alternative does not have an effect on the life time of the EEE or its usability.

� It is assumed that 20,000 t/y of DEHP are put on the market in the EU as part of EEE.

� It is assumed that about 400 companies use DEHP as plasticiser when producing plastics for EEE in the EU.

Table 36 summarises the described frame assumptions.

Table 36: Frame assumptions of the Socio Economic Analysis regarding a ban of DEHP

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 20,000

Number of affected plastic producers 400

In the following the impact of Scenario B (ban of DEHP) is compared to Scenar-io A (no ban of DEHP) 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 DEHP substitution costs will mainly fall at the PVC processors and formula-tors. For coatings and other integrated composite parts, the EEE manufacturers may act as PVC processors themselves, and may need to be involved in refor-mulation of the PVC plastisols (suspension of PVC particles in a plasticiser) or compounds used. The plasticiser producers will normally be involved in the substitution, because they act as advisors for the processors and formulators in the formulation of the polymer/plasticiser system. The alternative plasticisers are already developed and marketed, but costs for increasing the production


60 January 2014

volume may be implied. Costs for research in using alternatives for new applica-tions will be furthered to the customers (DEPA 2010).

Both DEHP and DINCH 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, DEHP containing parts may be produced by themselves or by subcontracting PVC processing companies 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 DEHP a one-to-one replacement of DEHP with DINCH will be possible and it is not expected that small and medium sized enterprises (SMEs) will be affected more than the general industry in the sectors in question with respect to the technical compliance. The plasticiser 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 DEHP is about 1 €/kg and of DINCH is 1.3 €/kg, so that by a DEHP ban additional material costs of 0.3 €/kg of plasticiser would occur. In addition DEPA (2010) estimates investment costs to be small. As no number is given by DEPA for the investment costs when switching from DEHP 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 of 0.05 €/kg of replaced DEHP.

In sum the material and investment costs for replacing 1 kg of DEHP by DINCH are estimated to be 0.35 €. For the 20,000 tonnes of DEHP to be replaced in European EEE this gives 7.1 million € per year in additional material and in-vestment 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 DEHP) 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.


January 2014 61

Additional costs which need to be covered by the EEE producers in addition to the above discussed material costs when banning the use of DEHP may in-clude:

� Costs for proving that the components of the EEE-products are DEHP free � Costs for developing, testing and approving alternative plasticiser.

To some extent the costs for proving DEHP freeness are taken into account by the administrative costs, discussed in the chapter below.

The level of development, testing and permitting costs very much depend on the availability of suitable, already tested and approved alternatives. While sev-eral comments of the stakeholder process on the restriction of hazardous sub-stances under ROHS stress these additional costs, none of them provide factu-al data on the level of these costs56. The strong decline in the use of DEHP in the last decades, indicate that for most applications suitable and technically feasible alternatives are available, tested and approved (COWI, 2009). There-fore no costs for developing, testing and approving alternative plasticisers for EEE producers are taken into account in this analysis.

As compared to the turnover of the EU electrical equipment industry of 279 bil-lion € in 2010 (Eurostat 2013), the additional costs of 8.2 million € (see Table 37) below) correspond to +0.003 % and is so small that no influence on the market needs to be feared.

9.4 Impact on EEE users

The major impact on EEE users, is the additional costs which are to be borne by the EU industrial and private consumers. It is to be expected that a some-what higher price of the EEE draws on the competitive position of the European industry as a whole causing some jobs to be lost. On the other hand, jobs are created as an essential part of the additional costs are spent for the benefit of European plastic producers and environmental industry.

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

56 SEMI Europe (2013): Feedback – Consultation on draft ROHs Annex II dossiers for HBCDD,

DEHP, BB, DBP.

EFRA (2013): RoHS questions on HBCD by Austrian UBA, 29.11.2013.

BVMed (2013): BVMed Comment – RoHS2: Study for the Review of the List of Restricted Sub-

stances - Consultation on draft ROHs Annex II dossiers for HBCDD, DEHP, BB, DBP.

Orgalime (2013): RoHS2: Study for the Review of the List of Restricted Substances - Consultation

on draft ROHs Annex II dossiers for HBCDD, DEHP, BB, DBP. Brussels, 29.11.2013

Edma & Eucomed (2013): no title, 29.11.2013


62 January 2014

9.5 Impact on waste management

For details on impacts of DEHP in EEE on waste management refer to Chapter 7.1.

In total the benefits for the waste management sector of banning DEHP in EEE can be summarized as:

� Reduced environmental and health impacts

� Possible increased PVC recycling potential

� Reduction in the generation of hazardous wastes

For the waste management sector no substitution costs occur, as with the exist-ing equipment DINCH containing plastics can be treated as well as DEHP con-taining plastics.

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 DEHP cannot be de-termined by simple XRF screening, therefore sampling, extraction and laborato-ry analysis (gas chromatography followed by mass spectroscopy) is required.

The price of an analysis of DEHP in a flexible PVC is in Denmark is reported to be about 160 € DEPA (2010).

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

� DEPA (2010) estimates that the additional costs for proving that the produced plastics is DEHP free is 160 €.

� 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 DEHP ban, the costs for the EU as a whole would be 1.1 million € 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

The total economic costs of a DEHP ban and replacement by DINCH (Scenario B) are estimated to lie with 8.2 million € annually (see Table 37).

The total effect on jobs is expected to be small. While some jobs are 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 environ-mental (chemical analysis) industry.


January 2014 63

With respect to the benefits, however, the impact of the DEHP ban is big:

� Increase in the competitive position of environmentally friendly industry

� Globally reduced environmental and health impacts during DEHP and plas-tics production

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

� Possibly increased recycling potential for PVC.

In total the ban of DEHP in EEE would create limited additional costs while cre-ating substantial additional benefits for health, environment and economy.

Table 37: Scenario Management Tableau of the Socio Economic Analysis regarding a ban of DEHP as plasticiser for

materials in EEE (electrical and electronic equipment)

Scenario A – no ban of DEHP

Scenario B – ban of DEHP

Difference of Scenarios (B-A)

Plasticiser used in EEE plastics DEHP DINCH

Additional raw material costs of plasticiser in €/kg 0 0.3 0.3

Additional investment costs for changing to other plasticiser in €/kg

0 0.05 0.05

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

0 0.35 0.35

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

0 7,100,000 7,100,000

Additional costs for EEE producer in €/y 0 no data available -

Additional costs for waste treatment in €/y 0 0 0

Additional administrative costs in €/a 1,120,000 1,120,000

Total additional costs for final consumers 0 8,220,000 8,220,000

Benefits Increase in the competitive position of environmentally friendly industry

Reduced environmental and health impacts during plasticiser and plastics production in the EU and abroad

Reduced environmental and health impacts during the use and especially the waste phase

1 As the ban becomes effective only gradually due to an adequate transition period and as plastics

containing DEHP 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.


64 January 2014

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

Hazardous potential

Nature and reversibility of the adverse effects

DEHP is a substance of very high concern because of its toxicity to the reproduc-tive system, the kidney and the liver. Data from animal studies and occupational exposure clearly demonstrate its adverse effects. Especially the effects on un-born babies are of major concern as they are believed to be long lasting effects.

DEHP releases during WEEE treatment

The majority of environmental releases of DEHP from relevant WEEE treatment processes57 are releases to air. The total annual releases are estimated to be 0.9 to 6.8 tonnes. A minor part is released to waste water (235 kg/a) 58.

The RAR for DEHP (EC, 2008) estimates releases from paper recycling, car shredders, incineration and municipal landfills. In addition, releases from prod-ucts which remain in the environment after their use are estimated.

In a scenario where emissions of particulates at shredder plants and cable shred-ders are successfully prevented, DEHP releases to air from WEEE treatments (0.9 t/a) are lower compared to releases to air from other waste treatment and disposal processes (20 t/a). However, in a scenario where only a few measures for preventing dust emissions from shredders are taken, the WEEE treatment processes contribute with 6.8 t/a DEHP considerably to these releases.

Given that the WEEE material streams are mechanically treated several times during the whole treatment process, it is expected that the actual releases might even be higher.

The RAR identifies landfills as the most relevant waste treatment process with respect to DEHP releases to water (15 t/a). Estimated releases from WEEE treatment are comparably low (0.2 t/a). Also, the contribution of disposed of WEEE to DEHP releases from landfills is low. According to COWI (2009), the overall DEHP input into landfills is 195,000 t/a. DEHP entering landfills via WEEE is estimated to be approximately 5,360 t/a.

Independent of the extent to which emission prevention measures have been implemented at WEEE treatment plants, the contribution of the WEEE treatment processes to the overall releases of DEHP to air (546 t/a, see Table 38 below) is low. In addition, releases of DEHP are also expected from landfills, incinera-tion plants and uncontrolled treatment of WEEE.

57 i.e. treatment of WEEE in shredders, cable shredders and recycling of PVC 58 In general, RAR DEHP provides little information on releases of DEHP containing products once

they have become waste.

Substance of very

high concern

WEEE treatment

compared to other

waste treatment

processes

Releases from

WEEE treatment

compared to total

DEHP releases


January 2014 65

Table 38: Summary of total DEHP emissions (Source: Table 3.37 of the RAR for DEHP,

EC, 2008)


66 January 2014

Exposure of workers

Based on an estimated number of 450 installations in the EU where WEEE and materials derived thereof are treated mechanically59 and assuming 5 to 15 workers per installation60, the estimated range of workers exposed to DEHP re-leases ranges between 2,250 to 6,750.

Based on an estimated number of 9 installations where recycled PVC is formu-lated from WEEE and 9 installations where recycled PVC is further processed and made into articles, and taking into account an average of 25 employees in the plastics processing sector, the number of workers affected by DEHP expo-sure is estimated to be 450.

Human health risk

The European risk assessment report on DEHP concludes that there is a need for limiting the risks from use of DEHP at workplaces. Several risk reduction measures have been taken so far. For waste treatment activities only limited in-formation on working conditions and risks for workers is available. Single meas-urements at shredding facilities operated by Plastics Recyclers Europe found concentrations below the DNEC and DNEL with short exceedances during spe-cific tasks (i.e. loading activities (FoBig, 2013)). These measurements, although limited, are in line with the results of ECETOC modelling for shredder facilities. It can be concluded that specific working tasks in shredding and recycling facili-ties may lead to exposure concentrations above the reference value (DNEC) derived by the Risk Assessment Committee (RAC) of the European Chemicals Agency. Therefore, it can be assumed that a possible health risk for workers cannot be excluded.

Under comparably unsafe working conditions, e.g. in third countries, a risk from DEHP exposure expected for workers and residents in the neighbourhood is even more likely. These health effects include: repeated dose toxicity effects on kidney and testes, as well as effects on fertility and development. Future gener-ations might be affected.

An assessment of endocrine disruptors within the regulatory framework of the European Union is currently under discussion. As it is not possible to establish a threshold for the adverse effects of genotoxic carcinogens, the possibility of es-tablishing such a threshold for endocrine disrupters is under debate. Therefore, releases of and exposure to endocrine disrupters such as DEHP should be min-imized.

59 This estimate is based on the following information: 220 (EC, 2012b) to 232 (IPTS, 2007) large-

scale shredder plants are operated in the EU. According to information available from Austria

(Umweltbundesamt, 2008) and France (contribution to stakeholder consultation, WEEE Forum)

there are at least as many mechanical treatment plants for WEEE as there are other large-scale

shredders. Other stakeholders who participated in the project estimated that there were at least

100 installations. The total number of mechanical treatment plants was therefore estimated to be

450. 60 Estimation based on Umweltbundesamt (2008)

Workers in

mechanical

treatment of WEEE

Workers in plastics

recycling


January 2014 67

Environmental exposure

DEHP is a widespread environmental pollutant, found in the food chain and in the human diet. Environmental exposure resulting from the mechanical treat-ment of WEEE and recycling of WEEE plastics has been estimated using the EUSES. 2.1 system for the evaluation of substances. Environmental monitoring data on WEEE sites in Europe are lacking. Monitoring data on comparable in-dustrial processes show elevated concentrations of DEHP in the surrounding environment. Studies conducted in specific non-European countries have shown environmental contamination with DEHP near WEEE treatment sites. DEHP degrades slowly and has a potential for bioaccumulation.

Risk for the environment

The predicted environmental concentrations in earthworms - even if overesti-mated by the EUSES system - predict a risk to mammalians and birds due to secondary poisoning; this is in line with other industrial processes where DEHP is used.

Main influencing factors within the risk assessment

There are 3 major factors influencing the result of the risk assessment:

� The annual quantities of DEHP contained in the collected WEEE depend on: the actual DEHP quantities put on the European market via EEE, the lifespan of EEE, the actual WEEE collection rate.

� The degree to which measures for preventing dust emissions are applied when handling materials derived from shredded WEEE affects the estimated DEHP releases considerably. However, there is no information available on the actual implementation of such measures.

� The risk for workers depends on the use of local exhaust ventilation and whether personal protective equipment is used, e.g. gloves. Data on the ac-tual working conditions at WEEE treatment plants are sparse.

The environmental exposure estimate is based on EUSES which (as yet) does not address waste treatment specifically. Thus, appropriate scenarios were de-fined, and emissions and releases were calculated and used as input parame-ters.

Impact on waste management

The extent to which material recycling/recovery is affected

Taking into account the regulations pertaining to the use of DEHP (e.g. under REACH) it is expected that the recycling possibilities for PVC will be reduced due to the presence of DEHP in WEEE plastics.

The extent to which DEHP remains in the recycling loop

Currently recycled PVC is used for the production of low value articles (shoe soles, hoses etc.). Thus it is not expected that DEHP will stay in the recycling loop for long.


68 January 2014

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

processing WEEE

Wastes with a DEHP content of 0.5% are considered hazardous. Assuming a separating and shredding rate of 80% for all WEEE cables, the estimated amount of hazardous waste generated per year is 110,000 tonnes61.

Available Alternatives

Detailed assessments on possible alternatives were carried out recently (Maag et al.; 2010, COWI; 2009, ECHA; 2013). Besides the hazard profiles of such substitutes, their use and technical feasibility were also determined. The results of these assessments show that the substitution of DEHP by less harmful sub-stances (e.g. ASE, DINCH) is possible and already being done. The use of DEHP in EEE is not considered to be essential. However, some niche applica-tions cannot be ruled out.

Socio-economic impacts

In total, a ban on DEHP in EEE would create limited additional costs while cre-ating substantial additional benefits for health, environment and the economy.

The overall impact on jobs/employment is expected to be small. While some jobs are expected to be lost in industries where EEE is used (due to a marginal increase in prices for EEE), some new jobs are likely to be created in the pro-duction of alternative plasticisers and in the environmental (chemical analysis) sector.

With respect to the benefits, however, the impact of a DEHP ban is expected to be substantial:

� Increase in the competitive position of an environmentally friendly industry

� Global reduction of environmental and health impacts from DEHP and plas-tics production

� Reduction of the environmental and health impact from the use of DEHP-containing EEE and especially of impacts arising during the waste and recy-cling phase

61 60,000 tonnes of cable and 40,000 tonnes of plastic fractions resulting from the mechanical

treatment of cables.


January 2014 69

Conclusion:

It is recommended that DEHP should be included in Annex II to the RoHS-Directive. A restriction of DEHP under RoHS is considered to be an appropriate measure to reduce any negative effects arising from - or on - WEEE manage-ment because:

� A risk for the environment (secondary poisoning of mammalians and birds) must be expected from the relevant WEEE treatment processes (i.e. the handling of materials at shredder sites, shredding of cables and recycling of PVC derived from WEEE). Occupational exposure estimates for workers in WEEE treatment plants indicate that exceedances of safe exposure levels derived by the risk assessment committee of the European Chemicals Agen-cy are possible. Therefore, a risk for workers cannot be excluded.

� DEHP releases from sites for the mechanical treatment of WEEE and cables and from PVC recycling are relevant contributors to the overall releases to air from treatment of DEHP containing wastes in a scenario where measures for preventing dust emissions are insufficient.

� There are considerable negative impacts on waste management (reduced recycling possibilities due to regulations for DEHP, generation of considera-ble amounts of hazardous waste).

� alternatives with less negative properties are available and technically and

economically feasible (e.g. ASE or DINCH)

� the socio-economic impact analysis indicates that a restriction of DEHP would have several benefits, including reduced risks and a less negative im-pact on waste management. Additional costs would be incurred in some sec-tors, i.e. by producers of chemicals and in the production of EEE.

The proposed maximum concentration value of DEHP to be tolerated in EEE is 0.1 weight % per homogenous material. Given the level of risk identi-fied when assuming a DEHP concentration in PVC of a few % it can be ex-pected that a maximum concentration of 0.1 weight % will lead to significantly reduced risks.

� alternatives with less negative properties are available and technically and

economically feasible (e.g. ASE or DINCH)

� the socio-economic impact analysis indicates, that a restriction of DEHP would have several benefits, including reduced risks and less negative im-pacts on waste management. Additional costs would be incurred in some sectors, i.e. producers of chemicals and production of EEE.

The proposed maximum concentration value of DEHP to be tolerated in EEE is 0.1 weight % per homogenous material. Given the level of risk identi-fied when assuming a DEHP concentration in PVC of a few % it can be ex-pected that a maximum concentration of 0.1 weight % will lead to significantly reduced risks.


70 January 2014

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January 2014 77

12 ABBREVIATIONS

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

BAT AEL ............. BAT associated emission level

BAT .................... Best available technique

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

BCF .................... Bio-concentration factor

BREF WTI .......... Reference document on best available techniques for the waste treat-

ments industries

bw ....................... Body weight

DBP .................... Dibutyl phthalate

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

DIDP ................... Di-disodecyl phthalate

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

DINP ................... Di-isononyl phthalate

DNEL .................. Derived no effect level

dwt ...................... Dry weight

ECETOC TRA .... European Centre for Ecotoxicology and Toxicology of Chemicals: (in-

dustry association for developing science in human and environmental

risk assessment of chemicals) Targeted Risk Assessment

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

EUSES ............... The European Union System for the Evaluation of Substances

HDPE ................. High density polyethylene

LD ....................... Lethal dose

MOS ................... Margin of safety

MSW ................... Municipal solid waste

NOAEC ............... No observed adverse effect concentration

NOAEL ............... No observed adverse effect level

PAE .................... Phthalic acid esters

PE ....................... Polyethylene

PM ...................... Particular matter

PNEC ................. Predicted no effect concentration

POD .................... Point of departure

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

RFair ................... Release factor to air

TDI ...................... Tolerable daily intake

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


78 January 2014

13 LIST OF TABLES

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

Table 2: Physico-chemical properties of DEHP (Source: ECHA, 2008a ;ECB, 2008) ............................................................................................................ 6

Table 3: Harmonized classification of DEHP1 ..................................................... 7

Table 4 : Examples of key developmental and repeated-dose toxicity studies (Source: ECB, 2008) .................................................................................. 16

Table 5: Overview of the deduced DNELs for DEHP (Source: RAC, 2013) ..... 18

Table 6: Selected environmental parameters in comparison with PBT and POPs

criteria ......................................................................................................... 20

Table 7: Deduced predicted no effect concentrations (PNECs) (Source: ECB, 2008) .......................................................................................................... 21

Table 8: Possible presence of DEHP in the 10 WEEE categories as specified by Annex I to the WEEE Directive (Source: DEPA, 2010) .............................. 22

Table 9: Estimated quantities of DEHP entering the main treatment processes for WEEE and secondary wastes derived thereof (in tonnes per year) 27

Table 10: Estimated total DEHP releases from WEEE treatment processes in the EU (in kg per year) ............................................................................... 33

Table 11: Estimated local DEHP releases from WEEE treatment processes in the EU (in g per installation and day) ......................................................... 33

Table 12: Results of the ECETOC-TRA model for exposure and risk of shredding .................................................................................................... 36

Table 13: Results of the ECETOC-TRA model for long term exposure to DEHP : rec.form ...................................................................................................... 38

Table 14: ECETOC TRA calculation recycling formulation: without gloves ...... 38

Table 15: Results of the ECETOC-TRA model for long term exposure to DEHP, recycling without LEV and PP .................................................................... 40

Table 16: Results of the ECETOC-TRA model for long term exposure to DEHP : recycling use with LEV, but no PP ............................................................. 41

Table 17: Results of the ECETOC-TRA model for long term exposure to DEHP: rec. use ....................................................................................................... 41

Table 18: Monitoring levels of DEHP in different environmental compartments (Source: ECB, 2008) .................................................................................. 44

Table 19: Selected EUSES input parameters ................................................... 45

Table 20: Selected EUSES input parameters: overall shredding ...................... 46

Table 21: Results of environmental assessment using EUSES: overall shredding .................................................................................................... 46

Table 22: Results of PECs for secondary poisoning: overall shredding ........... 46

Table 23: Selected EUSES input parameters: cable shredding ........................ 47


January 2014 79

Table 24: Results of environmental assessment using EUSES: cable shredding .................................................................................................................... 47

Table 25: Results of PECs for secondary poisoning: cable shredding ............. 47

Table 26: Additional input parameters for the recycling formulation scenario .. 48

Table 27: Results of environmental assessment using EUSES: recycling formulation .................................................................................................. 48

Table 28: Results of PECs for secondary poisoning: recycling formulation ...... 48

Table 29: Additional input parameters for the recycling use scenario .............. 49

Table 30: Results of environmental assessment using EUSES: recycling use 49

Table 31: Results of PECs for secondary poisoning: recycling use .................. 49

Table 32: Environmental monitoring data from sites near to e-waste plants .... 51

Table 33: PEC/PNEC ratios for the different scenarios .................................... 53

Table 34: Summary of most relevant concerns of alternatives for DEHP used in the EEE sector (for details see ECHA, 2013; DEPA, 2011) ...................... 57

Table 35: Deduced DNELs for general population for DINP, DIDP, DINCH, ASE

and DEHP (ECHA, 2013b; COWI, 2009) .................................................. 58

Table 36: Frame assumptions of the Socio Economic Analysis regarding a ban of DEHP as plasticiser of plastics used in EEE (electrical and electronic equipment) ................................................................................................. 59

Table 37: Scenario Management Tableau of the Socio Economic Analysis regarding a ban of DEHP as plasticiser for materials in EEE (electrical and electronic equipment) ................................................................................. 63

In addition, releases of DEHP are also expected from landfills, incineration plants and uncontrolled treatment of WEEE.Table 38: Summary of total DEHP emissions (Source: Table 3.37 of the RAR for DEHP, EC, 2008) .. 65


80 January 2014

14 LIST OF FIGURES

Figure 1: Large-scale metal shredder plant (Source: Umweltbundesamt, 2008) .................................................................................................................... 30

Figure 2: Manual sorting of disintegrated WEEE (Source: Umweltbundesamt, 2008) .......................................................................................................... 30

Figure 3: Installation for further treatment of mixed shredder fractions (Source: Umweltbundesamt, 2008) .......................................................................... 31

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