ROHS ANNEX II DOSSIER DEHP

Transcription

1 ROHS ANNEX II DOSSIER DEHP Proposal for restriction of a substance in electrical and electronic appliances under RoHS Substance Name: Bis(2-ethylhexyl)phthalate EC Number(s): CAS Number(s): January 2014

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3 Contents 1 IDENTIFICATION, CLASSIFICATION AND LABELLING, LEGAL STATUS AND USE RESTRICTIONS Identification and physico-chemical properties of the substance Name, other identifiers and composition of the substance Physico-chemical properties Classification and Labelling Status Legal status and use restriction USE OF DEHP Use and function of the substance Use of DEHP in EEE Quantities of DEHP used in EEE HUMAN HEALTH Human health hazard Endpoints of concern Existing Guidance values ENVIRONMENT Environmental fate properties Environmental hazard Eco-toxicity Potential for secondary poisoning Existing guidance values (PNECs) WASTE MANAGEMENT OF ELECTRICAL AND ELECTRONIC EQUIPMENT WEEE categories containing DEHP Relevant waste materials/components containing DEHP Waste treatment processes applied to WEEE containing DEHP Treatment processes applied DEHP flows during treatment of WEEE Treatment processes selected for assessment under RoHS Releases from the relevant WEEE treatment processes Shredding of WEEE Shredding of cables PVC-Recycling Summary of releases from WEEE treatment EXPOSURE ESTIMATION Human exposure January

4 6.1.1 Exposure estimates of workers of EEE waste processing plants Monitoring of human exposure at EEE waste processing plants Environmental exposure Exposure estimates for the environment due to WEEE treatment Monitoring data: WEEE treatment sites/locations IMPACTS ON WASTE MANAGEMENT Impacts on WEEE management as specified by Article 6 (1) a Risks estimation for workers and neighbouring residents Risks estimation for the environment ALTERNATIVES Availability of alternatives Hazardous properties of alternatives Conclusion on alternatives DESCRIPTION OF SOCIO-ECONOMIC IMPACTS Approach and assumptions Impact on producers of plasticisers and plastics Impact on EEE producers Impact on EEE users Impact on waste management Impact on administration Total socio-economic impact RATIONALE FOR INCLUSION OF THE SUBSTANCE IN ANNEX II OF ROHS REFERENCES ABBREVIATIONS LIST OF TABLES LIST OF FIGURES January 2014

5 1 IDENTIFICATION, CLASSIFICATION AND LABELLING, LEGAL STATUS AND USE RESTRICTIONS 1.1 Identification and physico-chemical properties of the substance 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 CAS number IUPAC name Index number in Annex VI of the CLP Regulation Bis(2-ethylhexyl)phthalate Molecular formula C 24H 38O 4 Molecular weight range 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 -- January

6 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 Physical state at 20 C and kpa Melting/freezing point Boiling point Value Colourless oily liquid -55 C or -50 C 230 C at 5 mm Hg; 385 C at 1013 hpa Vapour pressure Pa at 20 C Water solubility 3 µg/l at 20 C Partition coefficient n-octanol/water (log P OW) 7.5 Dissociation constant -- Flashpoint 200 C Autoignition temperature 370 C Henry s law constant 4.43 Pa m 3 /mol 1.2 Classification and Labelling Status The Classification, labelling and packaging (CLP) 1 Regulation requires companies 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 Chronic 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 Agency 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 for details see: 6 January 2014

7 January Table 3: Harmonized classification of DEHP 1 Index No International Chemical Identification EC No CAS No Classification Labelling DEHP di-(2-ethylhexyl) phthalate bis(2-ethylhexyl) phthalate Hazard Class and Category Code(s) Hazard statement code(s) Pictogram, Signal Word Code(s) Repr. 1B H360FD GHS08 Dgr Hazard statement code(s) Suppl. Hazard statement code(s) Spec. Conc. Limits, M-factors H360FD 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 Notes ROHS Annex II Dossier DEHP

8 1.3 Legal status and use restriction Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation 3,4 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 market, 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 proposes a ban on placing on the market articles intended for indoor use and in articles 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 justified 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 reduction measures (ECHA, 2012c). Specific restrictions for certain phthalates in toys and childcare articles are already 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 Dibutyl-phthalate (DBP) shall not be used as substance or in mixtures in concentrations 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 4 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 Registration, Evaluation, Authorisation and Restriction of Chemicals ( REACH ) 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 Registration, 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, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII 8 January 2014

9 Food Contact Material Regulation 6 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 containing 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 Regulation 7 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 Cosmetics Regulation. Environmental quality standards 8 Furthermore, the substance is listed in Annex I to the Directive on environmental quality standards (2008/105/EC) in the field of water policy. The annual average 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 European Pollutant Release and Transfer Register. 9 6 Commission Regulation (EC) No 10/2011 of 14 th January 2011 on plastic materials and articles intended to come into contact with food Regulation (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products Directive 2008/105/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008 on environmental quality standards in the field of water policy 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 January

10 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 polymers 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. extraction with soapy water/oils, by evaporation and by diffusion. 2.2 Use of DEHP in EEE Main us 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 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 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 plasticiser 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 particular, is used for other uses than EEE. PVC-cables are also used for installations in buildings, industrial facilities and infrastructure). DEHP quantity in European EEE On the basis of various different information sources (e.g. COWI, 2009, Andersson, 2005; ECB, 2008; PlasticsEurope, 2007), the Danish Environmental Pro- 10 compare Ökoinstitut (2008); January 2014

11 tection Agency estimated in 2010 that the EEE marketed in the EU contain approximately 5,000 to 20,000 t/y of DEHP (DEPA, 2010). In Mio tonnes of EEE were placed on the market in the EU stat 12 ). Assuming a plastic content in EEE of 30% of the appliances weight 13, a 12% share of the EEE plastics being PVC 14, a plasticiser content in PVC of 20-60% 15, and a 11% share of DEHP within used plasticizers 16 would lead to an assumption of 7,444 to 22,334 tonnes 17. For non-european markets, where REACH does not apply, it cannot be assumed 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. 12 Waste Electrical and Electronic Equipment (WEEE) statistics (env_waselee): extracted August See e.g. Schlummer et al (2007) VKE, 2003 IPTS, 2013 DEPA, ,400,000 * 0.3 *0.2*0.12*0.11= 7,444 t // 9,400,000 * 0.3 *0.2*0.12*0.11= t January

12 3 HUMAN HEALTH 3.1 Human health hazard Hazard assessments in brief Acute toxicity/ Irritating and sensitising properties Mutagenicity and carcinogenicity 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 report series (ECB, 2008) and a re-evaluation considering a potential carcinogenic 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 LD 50 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 sensitizing 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 mechanism 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, postulate that the drawn conclusion that PPARα agonists (such as DEHP) pose no risks to humans should be re-examined (Guyton et al., 2009). Furthermore, other tumour sites (Leyding cell and pancreatic acinar cell tumours) have been observed in rodent studies, the significance of which for humans cannot be unambiguously clarified. The non-hepatic tumours may be mediated through mechanisms independent of peroxisome proliferation (NRC, 2008). A recent reevaluation 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 system in rodents of both sexes. Furthermore DEHP exposure has a negative impact 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 regard to further risk characterisation within the EU RAR. Reproductive and developmental effects 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 12 January 2014

13 as in repeated dose toxicity studies. Depending on the study design DEHP possesses 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 malformations 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). NOAEL used for DNEL derivation 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. Testicular 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 malformations. 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 biomonitored 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 exposure and female reproductive system are sparse (Lyche et al., 2009, Vanessa et al., 2013). Phthalate exposure: Review of human studies 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, methodological weakness), to draw any firm conclusion more information is needed. More studies are available investigating the effect of reproductive and developmental effects in males. Some epidemiological studies demonstrate an association between phthalate exposure and disturbance of normal sperm function, 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 angiogenital distance (AGD), which is an endpoint for hormonally regulated sex differentiation, has been confirmed for the first time in a human study conducted January

14 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 consistence 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 including asthma and eczema. Moreover, In some studies alterations in child behaviour has been associated to phthalate exposure (Braun et al. 2013, Jurewicz, 2011). Epidemiological studies and DEHP exposure Endocrine disruption Cancer Repeated dose toxicity A summary of recent epidemiological human studies and observations in humans 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 systems 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 influence 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 pathways 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 targets 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) incidence of tubule cell pigments, and (iv) incidence and/or severity of chronic progressive nephropathy. 14 January 2014

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

16 16 January 2014 Table 4 : Examples of key developmental and repeated-dose toxicity studies (Source: ECB, 2008) Study type Species Application and exposure levels Reproductive toxicity Three-generation study (according to OECD guideline 416) Continuous breeding study (GLP and guideline study) Repeated dose toxicity 2 years (according to GLP principles, comparable to guideline study) Crl:CD(SD) rats; males and females CD-1 mice; males and females F-344 rats, males and females Orally; in the diet. 1.5; 10; 30; 100; ; 7.500; ppm 0, 20, 200 or 600 mg/kg bw/day Orally; in the diet 0, 5.8, 28.9, or mg/kg/day, respectively, for males, and 0, 7.3, 36.1, or mg/kg/day, respectively, for females Outcome LOAEL(*) NOAEL(*) Reference 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 Dose-dependent decreased fertility; reduced number of litters and proportion of live pups; both sexes were effected Reduced weight of reproductive organs. 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. 14 mg/kg bw/day 4.8 mg/kg bw/day for testicular toxicity; 46 mg/kg/day for fertility Wolfe et al., mg/kg bw/day 20 mg/kg bw/day Lamb et al., mg/kg bw/day 29 mg/kg bw/day Moore, 1996 ROHS Annex II Dossier DEHP

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/m 3 (GESTIS, 2013). No OEL has been derived by the European Scientific Committee on Occupational Exposure limits for DEHP (SCOEL) so far. The German maximum workplace concentration value (MAK) for example is 10 mg/m 3. The threshold limit value (TLV) of the American Conference of Governmental Industrial Hygienists (ACGIH) is 5 mg/m 3 (IARC, 2013). The tolerable daily intake (TDI), which is an estimate of the amount of a substance 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 derivation the outcome of the study of Wolfe et al. (2003) was used as point of departure (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 observed 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 absorption between rats (70%) and humans (100%). Applying the overall assessment factor of 100 an oral DNEL of mg/kg/day was derived by the RAC for the general population. The oral NOAEL rat was converted into a dermal corrected NOAEL by correcting for differences in absorption between routes (5% absorption is considered for the dermal route). Further correction for exposure during 5 days a week instead 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 corrected NOAEC (in mg/m 3 ) by using a default respiratory volume for the rat corresponding to the daily duration of human exposure followed by a correction for differences in absorption between routes (70% oral absorption in rats, 75% inhalation 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 January

18 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 Intraspecies 5 10 Dose response (LOEAL to NAEL) 1 1 Quality of database 1 1 Applied Factor* ORAL Absorption (%) 100% 100% NOAEL corrected (not relevant) 3.36 DNELs ORAL in mg/kg/d (not relevant) DERMAL Absorption (%) 5% 5% NOAEL (corrected) DNELs DERMAL in mg/kg/d INHALATION Absorption (%) 75% 75% (Adults) 100% (Children) Standard respiratory volume in m 3 /kg bw per day NOAEC (corrected) (Adults) 2.92 (Children) DNECs INHALATION in mg/m (Adults) 0.12 (Children) * interspecies assessment factor was not applied when calculation inhalation DNECs Outcome of EU risk assessment (2008) 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 reduction measures which are already applied shall be taken into account. 18 more details on DNEL derivation are described in following ECHA document 18 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 described 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 reduce 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 bioaccumulation factor (BCF) value was observed for invertebrates e.g. 2,700 for Gammarus. The BCF for fish is 840. Monitoring data for different trophic levels, indicate that DEHP does not bio-magnify. Biodegradation Persistence Bioaccumulation 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 compartments of the environment. The log Koc for DEHP is 5.2. Hence, DEHP will be strongly adsorbed to the organic 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. January

20 Table 6: Selected environmental parameters in comparison with PBT and POPs criteria Parameter Outcome PBT criteria (according REACH, Annex XIII) Half-lives Surface water Aerobic sediments 50 ds 300 ds 40 ds 120 ds Log Kow >5 Log Koc Bio-concentration factor 840 (bio-concentration tests with fish) 2700 (Grammarus) POPs criteria (Stockholm Convention) >60 ds >180 ds >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 Eco-toxicity Main conclusion of eco-toxicity studies Studies carried out to determine possible adverse effects to the aquatic organism 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 observed 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, 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 Potential for secondary poisoning Secondary poisoning is a phenomenon related to toxic effects which might occur 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. 20 January 2014

21 A NOEC of 33mg/kg food 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/kg food has been observed. Secondary poisoning 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. PNECs for different compartments 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 mg/kg food (mammalians) 17 mg/kg food (birds) 16 mg/kg food (fish) January

22 5 WASTE MANAGEMENT OF ELECTRICAL AND ELECTRONIC EQUIPMENT 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 containing 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) Relevant waste materials/components containing DEHP Main materials/ components 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 appliances, it was estimated that at least half of the DEHP quantity is contained in internal 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 others 19 ), 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) 22 January 2014

23 5.2 Waste treatment processes applied to WEEE containing DEHP Treatment processes applied 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. Treatment of separately collected WEEE 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 shredder 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 landfilled. 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 undergo dismantling, dumping or any kind of combustion process. Treatment of WEEE ending up in unsorted MSW Treatment of WEEE shipped to third countries 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 separation. 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 PVC 20, PE 20, HDPE, VPE and rubber and a minor part of metals. Mixed plastics fractions from cable shredding are either incinerated (MSWincineration) 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 construction sector (outdoors and indoors, floors), road equipment, footwear. Further products are mats, garden hoses etc. Treatment of cables Treatment of plastics from cable shredding 20 According to Bipro (2002) approximately 60% are PVC, 30% PE January

24 Treatment of shredder residues Plastics containing fractions resulting from shredding of WEEE are usually either: Land-filled incinerated (incineration or co-incineration) in the form of mixed plastics enriched 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 assumed 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 Treatment of cables in third countries can also be open burning and smouldering DEHP flows during treatment of WEEE Waste management scenario for DEHP containing 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 corresponds to the total quantity of DEHP put on the European market via EEE 21, 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 considered for the present assessment. To estimate the flows of DEHP entering individual treatment processes in particular 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 (Eurostat, WEEE data for ), assumptions made by EC (2008b) based on figures for 2005 and on own estimations. WEEE treated in WEEE treatment plants in the EU Assumptions 44 % 23 of the overall WEEE arising 24 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 Eurostat: Waste Electrical and Electronic Equipment (WEEE) statistics (env_waselee); extracted August 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 processes as the comparable appliances reported as being separately collected. 24 January 2014

25 Taking into account also the composition of WEEE that are reported to be separately collected (Eurostat, WEEE- statistics 25 ) 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 initial 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 incinerated 26. WEEE whose fate is unknown 41 % of the overall WEEE arising (3.9 Mio t/a) are unaccounted and are assumed 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 cables 28. COWI (2009) estimate that DEHP containing wastes are predominantly incinerated or landfilled but not recycled. However, indication is given that recycling of PVC waste resulting from cables will increase. VinylPlus report about t of waste PVC cables being recycled in In ,400 t were recycled For the purpose of the present assessment the WEEE arising is seen equal to the amounts put on the market The shares of individual categories in the amounts reported to be separately collected were used See for example EEA (2013) Derived from figures for small WEEE in Salhofer & Tesar (2011) 28 4,100,000*0,8*0,02 = 65,600 January

26 (Vinylplus, 2013) Information to which extent these cables stem from WEEE is currently not available 29. 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. DEHP input into WEEE treatment processes 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 % is assumed 30. Half of the contained DEHP is in cables, half in other parts 31. Based on these assumptions the following DEHP quantities entering the individual 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 developed by the European Plastic converters in ,000 tonnes were cables from building applications. Less than 170,000 tonnes were cables from E&E 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 26 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 Re-Use Manual dismantling Shredding (and automated sorting) Separately collected WEEE 400 c 2,550 a WEEE in unsorted MSW WEEE shipped out of the EU Cables derived from pretreatment 3,750 b 3,520 f Shredder residues Landfilling (EU) 1,716 d 1,173 g 2,475 h Incineration (EU) 858 e 1,173 g 1,238 i Mechanical recycling (regrinding, pelletizing, extrusion etc.) Uncontrolled treatment in third countries (dismantling, dumping, smouldering, open burning) 8,200 j 1,173 g Secondary wastes from uncontrolled WEEE treatment in third countries (incl. ) 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 * 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 defined process carried out at large number of installations. There is a considerable 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 January

28 Less relevant processes effects of DEHP containing WEEE cables can be evaluated seperately (in a scenario). Recycling processes for PVC, because recycling of PVC, including PVC derived 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 determination 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 derived thereof are not the main source for DEHP in the incinerated waste usually. Furthermore a well functioning emission control is assumed. Treatment processes under uncontrolled conditions, because WEEE and materials 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 selected processes are summarized Shredding of WEEE Info on releases The most important route of DEHP from shredding of WEEE or plastics materials thereof is considered to be via emissions of dust. Emissions from shredders are typically abated by dust removal in a cyclone and a wet scrubber. According to the 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/nm 3. However, treatment of metal wastes, including WEEE, in shredders has been included into the scope of IED-Directive recently. Information on the actual dust emissions from shredders under current operational conditions is scarce 32. 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/nm 3 for German shredders have been reported (BDSV, 2012) 28 January 2014

29 In order to estimate DEHP releases via diffuse emissions of dust during manipulating material streams at sites where WEEE are shredded, the following assumptions were made: Assumptions concerning diffuse emissions 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/dust % of fluff/fines/dust are emitted diffusely via PM10 (under dry conditions, watering of the material and other measures for prevention of diffuse emissions 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/a 35. 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/nm 3. Furthermore, an exhaust air flow of 20,000 Nm 3 /h 36, and a treatment quantity of 60 t WEEE per hour 37 were assumed. Furthermore, it was assumed that the concentration of DEHP in dust is the same as in the processed WEEE (1.3 g/kg 38 ). Based on these assumptions 39 the total DEHP releases via residual dust emissions 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: Estimates of diffuse emissions Assumptions concerning channelled emissions Estimates of channelled emissions Releases per installation and day Typical daily WEEE throughput in a large-scale metal shredder is 250 tonnes 40 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) RFair: 0.09 to 0.9 g/kg E.g. described by Ortner (2012) 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) Resulting RFair: g/kg Capacities of typical large scale-metal shredders: t/h, assumption 7 working hours per day January

30 Further considerations Workplace description mechanical treatment of WEEE 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 assumed that not all of those installations are equipped with efficient dust prevention 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 process, 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 considered improvable. Figure 2: Manual sorting of disintegrated WEEE (Source: Umweltbundesamt, 2008) 30 January 2014

31 For the further mechanical treatment of mixed shredder residues different options are realized. Installations exist where the mostly encapsulated aggregates are operated outdoors or partly encased. Thus material manipulation by workers is carried out outdoors or in partly encased places with natural ventilation. Figure 3: Installation for further treatment of mixed shredder fractions (Source: Umweltbundesamt, 2008) Other installations have fully encapsulated grinding and sorting aggregates situated in a closed building with indoor air extraction. The manipulation of the material is carried out both, indoors and outdoors 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 estimate total diffuse and residual guided emissions. Total releases 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 processing of cables the following assumption was made: The daily throughput in a cable shredder is 32 tonnes 41 Based on the resulting daily DEHP input per installation of 1,701 kg 42 and using the release factors for DEHP as illustrated above 43 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 Releases per installation and day 41 Information on throughputs of cable shredders is available for example by is available from Umweltbundesamt (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 : g/kg; RF air diffuse: 0.09 to 0.9 g/kg January

32 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, preparation, melting, pelletizing, transfer and storage and through polymer processing by calendaring, extrusion, injection moulding etc. to form the final plastic products. Assumptions concerning total releases Estimates of total releases 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 lifecycle stages 2b Extrusion-compound (Formulation Compound) and 2f Injection 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. According 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 following 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 Assumption of releases per installation and day 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 cables 44 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 nonmetal 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 recycled: 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. 32 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 Estimates of releases per installation and day Downstream uses (injection moulding/extrusion) Releases to air: 30 g/d Releases to waste water: 30 g/d 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) Shredding (and automated sorting) of WEEE 338 3, Shredding of cables 317 3, Recycling of PVC Air (gaseous) Water (waste water) Formulation Injection moulding extrusion Total 938 6, Table 11: Estimated local DEHP releases from WEEE treatment processes in the EU (in g per installation and day) Air (particulates) diffuse Air (particulates) Shredding (and automated sorting) of WEEE Shredding of cables 153-1, Recycling of PVC Air (gaseous) Water (waste water) Formulation Injection moulding extrusion January

34 6 EXPOSURE ESTIMATION 6.1 Human exposure Humans are exposed to DEHP via use of consumer products and indirect environmental exposure or due to occupational exposure. For the general population, food is considered as major source of DEHP exposure. General population Breast milk Monitoring studies demonstrate that DEHP is found in almost all dietary products. 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 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 adolescents and 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 extent 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 ( 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 different 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 Finland (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 corresponding monoesters, and further to secondary metabolites, which are absorbed 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 compounds 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; Saravanabhavan, 2013). 34 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 assumptions and calculations provided in the chapter waste treatment and releases 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 established 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. ECETOC TRA 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 indicated explicitly by the uses and processes which can be selected, as the TRA tool is intended for industrial processes like manufacture or formulation. Limitations Therefore the most appropriate processes to describe the exposure conditions of waste treatment processes have been chosen 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 processes 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) RCR- Risk Characterisation Ratio January

36 and in dust of cable shredders is 5.3% 45. In table 12 the results of the assessment are summarized. Concentrations are given in µg/m 3. Table 12: Results of the ECETOC-TRA model for exposure and risk of shredding Parameter PROC WEEE shredders Cable shredders PROC Process category Long-term Inhalative Exposure Estimate (µg/m 3 ) Long-term Dermal Exposure Estimate (µg/kg/day) Long-term Inhalative Exposure Estimate (µg/m 3 ) Long-term Dermal Exposure Estimate (µg/kg/day) conc. solid 24a conc. solid 24b conc. solid 24c 14000** ** 2830 DEHP conc. 24a DEHP conc. 24b DEHP conc. 24c DNEC/DNEL *RCR 24a *RCR 24b *RCR 24c *RCR: Risk Characterization Ratio The comparison of exposure levels with hazard thresholds lead to the risk characterization. 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). Monitoring data Plastic recyclers Europe Inhalation exposure on the basis of monitoring data was estimated to be mg/m 3 (95th percentile; n=18) i.e. 51 µg/m 3 respectively and dermal exposure on the basis of modelling was estimated to be mg/kg bw/d (i.e. 135 µg/kg bw /day) (FoBiG, 2013). These data are within the range of the calculated scenario above. Whereas inhalation exposure is slightly overestimated (concentrations calculated for 24a are twice the 95 th percentile of measurements but within 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 concentrations 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 ,000 t / 9,400,000 t / 0,02 36 January 2014

37 Taking into consideration that other hazardous substances are present in the WEEE shredders risk for shredder workers cannot be excluded 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 parameter 46. It is assumed that the substance is dispersed in a solid matrix. Due to the limited 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% January

38 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 Exposure Estimate (mg/kg/day) Risk Characterisation Ratio - Long-term Inhalation Risk Characterisation Ratio - Long-term Dermal 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 Risk Characterisation Ratio - Long-term Total Exposure 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 Exposure Estimate (mg/kg/day) Risk Characterisation Ratio - Long-term Inhalation Risk Characterisation Ratio - Long-term Dermal 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 Risk Characterisation Ratio - Long-term Total Exposure 38 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. January

40 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 Exposure Estimate (mg/kg/day) Risk Characterisation Ratio - Longterm Inhalation Risk Characterisation Ratio -Longterm Dermal 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 Risk Characterisation Ratio - Long-term Total Exposure 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 articles) and PROC 21(low energy manipulation of articles: cutting, welding, gluing) 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 recycling different scenarios were calculated. The first scenario describes appropriate 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 40 January 2014

41 Table 16: Results of the ECETOC-TRA model for long term exposure to DEHP : recycling use with LEV, but no PP Process Long-term Inhalative Exposure Estimate (mg/m3) Long-term Dermal Exposure Estimate (mg/kg/day) RCR - Longterm Inhalation RCR - Long-term Dermal RCR - Longterm 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 - Longterm Inhalation RCR - Long-term Dermal RCR - Longterm 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 extent these conditions are covered by the ECETOC TRA model. Information about exposure conditions in recycling (formulation and use) processes 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 processes such as extrusion, compression and injection moulding etc..). The authorisation dossiers will be assessed by the European Chemicals Agency Risk Authorisation request for soft PVC containing DEHP January

42 Assessment Committee (RAC) and the Socio Economic Assessment Committee (SEAC) and their opinion is expected by September Monitoring of human exposure at EEE waste processing plants General monitoring of industries using DEHP Monitoring WEEE treatment Authorisation process soft PVC containing DEHP Several studies indicate that workers of industries, where DEHP is manufactured or used, have higher DEHP and/or DEHP metabolites concentration compared 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 excretion 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 recyclate 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 data according to EuPc (communication during stakeholder consultation). The authorisation dossiers will be assessed by the European Chemicals Agency Risk Assessment Committee (RAC) and the Socio Economic Assessment Committee (SEAC); their opinion is expected by September EuPC Monitoring Monitoring data, third countries The European Plastic Recyclers provided data on three shredder sites in Europe: a total of 16 personal shift average samples derived from personal sampling measurements (of seven workers) at 3 sites. DEHP was analysed in inhalable and respirable durst. The maximum shift average measured was 0.18 mg DEHP/m 3, with peaks at specific tasks of 1.3 mg DEHP/m 3, clearly exceeding the DNEC of 0.88 mg DEHP/m 3 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 voluntarily, may not be a representative sample for all European sites. Photographs provided demonstrate good personal protective measures and working conditions. Finally the monitoring data support the estimates provided in the previous chapter ( ); 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 recycling plant workers had statistically higher levels of urinary 8-hydroxy-2-deoxyguanosine levels, a marker of oxidative stress to DNA and possible risk for cancer. A multivariate analysis of data revealed that working history has been a risk 42 January 2014

43 factor for higher levels of the marker. The study was carried out with 181 workers and 160 farmers in Hunan Province, China. In the study also the DEHP levels were to a great extent higher in the environment (soil and water) at the recycling sites than at reference site (see Table 32). The authors relate the observed 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 aforementioned study. January

44 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 industrial areas. Releases of DEHP to the environment occur over the whole life-cycle as a result 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 disposal. Air samples Water samples Soil Sediment 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/m 3. 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 ng/m 3 Water River water Marine surface water Soil Agricultural soil Agricultural soil (application of STP sludge) Soil (without known DEHP source) < 0.1 up to 21 µg/l 1 < 0.1 µg/l mg/kg dw 0.12 up to 3,400 3 < 0,025 and 0.17 mg/kg dwt Sediment 0.04 and 21 mg/kg dwt industrial and highly urbanized sites having the highest levels 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 44 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 evaluation 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 calculate predicted environmental concentrations, the so called PECs for the scenarios which have been defined as most relevant: shredding, cable shredding 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 Assessment mode Assessment type Additional: Physical chemical properties Chemical class for Koc -QSAR Biodegradability Industry category Use category Use pattern input Interactive Local scale Predators exposed via the environment Physical chemical parameters Ester Fraction of the main local source 0.02 Number of emission days per year 220 readily-biodegradable with 10 day window 4: Electrical/Electronic engineering industry 47: Softeners Waste treatment EUSES Limitations EUSES Input parameters Exposure estimates: Shredding Overall Shredding Additional input parameters for the shredder scenario are given in table 20. As a worst case scenario in total kg 47 were taken as local emissions to the air as presented in table in chapter ,750 t/a (table 9) as total input of DEHP in WEEE shredders was taken as production volume ,1 g January

46 Overall Shredding: Input parameters 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 kg (max.) Local STP input Bypass STP The derived local PECs are given in Table 21 below. Shredding: PECs Table 21: Results of environmental assessment using EUSES: overall shredding DEHP concentrations and PECs result unit Concentration in air during emission episode ng/m 3 Annual average concentration in air, 100 m from point source ng/m 3 Local PEC in surface water during emission episode (dissolved) ng/l Annual average local PEC in surface water (dissolved) ng/l Local PEC in fresh-water sediment during emission episode 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 agric. soil (total) averaged over 180 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 concentrations in fish are summarized in Table 22. Shredding: PECs secondary poisoning 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 ,520 t/a as total input of DEHP in WEEE shredders was taken as production volume. 46 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 kg (max.) Local STP input Bypass STP Cable Shredding: Input parameters The derived local PECs are given in Table 24 below. Table 24: Results of environmental assessment using EUSES: cable shredding DEHP concentrations and PECs result unit Annual local PEC 0,28 µg/m 3 Local PEC in surface water during emission episode (dissolved) ng/l Annual average local PEC in surface water (dissolved) ng/l Local PEC in fresh-water sediment during emission episode µg/kg wwt Local PEC in seawater during emission episode (dissolved) 7.36 ng/l Annual average local PEC in seawater (dissolved) 7.36 ng/l Local PEC in marine sediment during emission episode 8.49 µg/kg wwt Local PEC in agric. soil (total) averaged over 30 days 390 µg/kg wwt Local PEC in agric. soil (total) averaged over 180 days 391 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 Cable Shredding: PECs Further the risk of secondary poisoning has been evaluated; the calculated concentrations in fish are summarized in Table 25. 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 fish for secondary poisoning (marine) 6.18 µg/kg wwt Concentration in fish-eating marine top-predators 6.18 µg/kg wwt Concentration in earthworms from agricultural soil 101 mg/kg Shredding: PECs secondary poisoning January

48 Exposure estimates: Recycling Recycling: input formulation 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 The derived local PECs are given in Table 27 below. Recycling: PECs formulation Table 27: Results of environmental assessment using EUSES: recycling formulation DEHP concentrations and PECs result unit Concentration in air during emission episode ng/m 3 Annual average concentration in air, 100 m from point source ng/m 3 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) ng/l Annual average concentration in seawater (dissolved) ng/l Local PEC in seawater during emission episode (dissolved) ng/l Annual average local PEC in seawater (dissolved) 30.5 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 Further the risk of secondary poisoning has been evaluated; the calculated concentrations in fish are summarized in Table 28. Recycling: formulation: Secondary poisoning 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 fish for secondary poisoning (marine) µg/kg wwt Concentration in fish-eating marine top-predators 3.11 µg/kg wwt Concentration in earthworms from agricultural soil 187 mg/kg 48 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 Recycling: use input parameters The derived local PECs are given in Table 30 below. Table 30: Results of environmental assessment using EUSES: recycling use DEHP concentrations and PECs result unit Concentration in air during emission episode 8.34 ng/m 3 Annual average concentration in air, 100 m from point source 5.03 ng/m 3 Concentration in surface water during emission episode (dissolved) 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) ng/l Annual average concentration in seawater (dissolved) 10 ng/l Local PEC in seawater during emission episode (dissolved) ng/l Annual average local PEC in seawater (dissolved) ng/l Local PEC in marine sediment during emission episode 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 Recycling: use PECs Further the risk of secondary poisoning has been evaluated; the calculated concentrations in fish are summarized in Table 31. Table 31: Results of PECs for secondary poisoning: recycling use Recycling: use Secondary poisoning DEHP concentrations secondary poisoning result unit Concentration in fish for secondary poisoning (freshwater) µg/kg wwt Concentration in fish for secondary poisoning (marine) 4.82 µg/kg wwt Concentration in fish-eating marine top-predators 1.45 µg/kg wwt Concentration in earthworms from agricultural soil 64.4 mg/kg Monitoring data: WEEE treatment sites/locations No monitoring studies near WEEE treatment plants in Europe are available. January

50 Only few environmental monitoring studies are available. All of them were carried out in China. Air Water Soil Plant Conclusion Measured concentrations in air samples of e-waste dismantling sites are in the range between to ng/m 3. DEHP exposure levels at e-waste dismantling sites were 2-fold higher compared to concentrations detected at control areas (80.62 to ng/m 3 ) (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 µg/l and 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 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 depicted in Table January 2014

51 January 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) Water Well water Pond water Industry water Soil Agricultural soil exposed site (summer): ng/m 3 (mean) exposed site (winter): ng/m3 (mean) reference site (summer): ng/m3 (mean) reference site (winter): ng/m3 (mean) exposed site: µg/l (mean: µg/l) reference site: µg/l (mean: 0.79 µg/l) exposed site: µg/l (mean: µg/l) reference site: µg/l (mean: 0.37 µg/l) exposed site: µg/l (mean: µg/l) reference site: - exposed site: mg/kg (mean: mg/kg) reference site: n.d mg/kg (mean: 0.81mg/kg) China China China China China E-waste dismantling area Plastic waste recycling site Plastic waste recycling site Plastic waste recycling site Plastic waste recycling site The mean concentration of DEHP is about 2 fold higher in the exposed site vs. reference 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 Mean levels were significant higher in the recycling than at reference site. The levels are 367-fold higher. Sampling year was Mean levels were significant higher in the recycling than at reference site. Sampling year was Mean levels are 16 fold higher than at the reference site. Sampling year was Soil exposed site: mg/kg* China E-waste recycling site Depending on kind of vegetables cultured on soils the phthalic acid ester varies. Gu et al., 2010 Wang et al., 2011 Wang et al., 2011 Wang et al., 2011 Wang et al., 2011 Ma et al., 2012 Soil exposed site: to mg/kg** China E waste Severely contamination of soils Liu et al., 2010 Plants Various kinds of vegetables exposed site: 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) ROHS Annex II Dossier DEHP

52 7 IMPACTS ON WASTE MANAGEMENT 7.1 Impacts on WEEE management as specified by Article 6 (1) a Recycling possibilities DEHP remaining in the recycling loop Generation of hazardous waste 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 allowed unless an authorization is granted for a particular use. Furthermore according to Annex XVII to REACH DEHP is restricted in toys and childcare articles. 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 value 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, reprotoxic 48 ). Considering a plasticiser-content in PVC of 20-60% 49, and a 20% share of DEHP within used plasticisers 50 the DEHP-concentration in PVC in WEEE cables is as a minimum 4% 51. Assuming a 40%-share of PVC in cables 52 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 nonmetal fraction of 44,000 tonnes 52 a generation of min. 110,000 t/a 53 of hazardous wastes arise 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 assumed that relatively high work temperatures, aerosol generation and considerable skin contact occur. There is concern for the testicular effects, fertility, toxicity to kidneys, on repeated exposure, and developmental toxicity for workers as a consequence of inha 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 IPTS, 2013 DEPA, 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 52 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 concentration which is expected to pose no risk is higher than 1 a risk can be expected and risk reduction measures should take place. In table 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 Aquatic compartment rec-form rec-use EQSwater* (µg/l) freshwater sediment (mg/kg) Terrestrial compartment > soil (mg/kg) > ,06 Secondary poisoning fish freshwater mg/kg 16 0,03 0,03 0, birds (mg/kg) Mammalian (mg/kg) PECs * 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) Mammalian (mg/kg) 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. January

54 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 value 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 reduction measures which are already applied shall be taken into account. This conclusion applied to the processing of polymers containing DEHP. 54 January 2014

55 8 ALTERNATIVES 8.1 Availability of alternatives Several alternative assessments for DEHP, DBP and BBP were conducted recently (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. Alternative assessments Beside other supposed less hazardous phthalate compounds, non-phthalate alternatives (e.g., Di-isononyl-cyclo-hexane-1,2dicarboxylate DINCH; Alkylsulphonic 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, indicating that suitable and technically feasible alternatives are available (COWI, 2009). DEHP in EEE According to DEPA (2010) the use of DEHP is not deemed necessary in electrical 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. Examples of alternatives 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 articles 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 sector 55. Di-isononyl phthalate (DINP) was assessed within the European Risk assessment 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 restricted. 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. Phthalate compounds used as alternatives 55 for further details on alternatives see Maag et al., 2010, COWI, 2009 January

56 DINP possess hepatotoxic effects. There are some disagreements related to its anti-androgenic potential. Even though DINP has shown anti-androgenic effects, 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 assessment 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 restricted. This measure was re-evaluated in the year 2013 by ECHA (ECHA, 2013) and no alteration of existing restriction of DINP and DIDP foreseen related to entry 52 in Annex XVII to REACH. Non-phthalate compounds Alkylsulphonic phenylester (ASE): ASE possess low acute toxicity and no irritating, 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 indicate any adverse effects up to doses of 530 mg/kg bw. However, the study dates back to 1956 and lacks good reporting. Therefore a clear conclusion might not be drawn. Di-isononyl-cyclohexane-1,2-dicarboxylate (DINCH) has not shown any adverse 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 mg/kg bw/ day. DINCH and ASE might be appropriate alternatives for DEHP regarding their toxic profile. According to EchoStar DINP, is a substitute for DEHP based on current practice (comment, stakeholder consultation, October 2013). 56 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 selfclassification (SC)* Phthalates 1,2-benzene-dicarboxylic acid, di-c8-10-branched alkyl esters, C9-rich/ di- isononyl phthalate (DINP) 1,2-Benzene-dicarboxylic acid, di-c9-11- branched alkyl esters, C10-rich/ di- isodecyl phthalate (DIDP) / / Significant in-creases of incidence of spon-giosis hepatis together with other signs of hepatotoxicity in rats. Disagreement regarding relevance of spongiosis hepatits in humans. endocrine disruptor** 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) No toxic effects towards fish, invertebrates or algae. Low bioaccumulation properties. no HC; SC: Aquatic Acute 1, Repr. 2, Skin Irrit. 2; Eye Irrit. 2 (for CAS ) no HC; SC: Aquatic Acute 1, Aquatic Chronic 1, Acute Tox 4 (for CAS ) no HC; SC: Skin Irrit. 2; Eye Irrit. 2 (for CAS: ) no HC; SC: Aquatic Acute 1, Aquatic Chronic 1, Aquatic Chronic 2, Skin Irrit. 2; Eye Irrit. 2 (for CAS ) Non-phthalates Di-isononyl-cyclohexane- 1,2dicarboxylate (DINCH) Alkylsulphonic phenylester (ASE) 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 mg/kg bw/day) Has not comprehensively studied for toxic effects. Not readily biodegradable. Data indicate moderate bioaccumulation potential. Not readily biodegradable and potential for bioaccumulation Data on aquatic organism indicate low toxicity. no HC; no SC no HC; SC: aquatic chronic 4 * indicated in the Classification and Labelling (C&L) inventory from ECHA (available at: ** 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. January

58 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/m 3 ) General population DNEL dermal (mg/kg) General popu-lation DINP 1 Liver toxicity DIDP 1 Liver toxicity ASE 2 Liver toxicity n.d. DINCH 2 Kidney toxicity n.d. DEHP 3 Testicular toxicity source ECHA, 2013b, 2 preliminary DNELs (COWI), 2009, 3 RAC, 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 substitutes 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. 58 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 assumptions 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 Effect on life time of EEE Assumption Consumption of plasticiser in t/y 20,000 Number of affected plastic producers 400 Negligible effect In the following the impact of Scenario B (ban of DEHP) is compared to Scenario 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 socioeconomic impacts. 9.2 Impact on producers of plasticisers and plastics The DEHP substitution costs will mainly fall at the PVC processors and formulators. For coatings and other integrated composite parts, the EEE manufacturers may act as PVC processors themselves, and may need to be involved in reformulation of the PVC plastisols (suspension of PVC particles in a plasticiser) or compounds used. The plasticiser producers will normally be involved in the substitution, 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 January

60 volume may be implied. Costs for research in using alternatives for new applications 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 electronics, 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 degree by compliance with the RoHS legislation compared to their larger competitors, 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 For the 20,000 tonnes of DEHP to be replaced in European EEE this gives 7.1 million per year in additional material and investment costs. With respect to jobs it is expected that the higher turnover of the plasticiser and plastic industry in Scenario B will create some additional jobs in this sector. In scenario B (ban of 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 electronics, IT equipment, and toys etc., but also for other EEE groups. 60 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 include: 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 several comments of the stakeholder process on the restriction of hazardous substances under ROHS stress these additional costs, none of them provide factual data on the level of these costs 56. 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). Therefore 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 billion in 2010 (Eurostat 2013), the additional costs of 8.2 million (see Table 37) below) correspond to % 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 somewhat 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 plasticisers. 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, BVMed (2013): BVMed Comment RoHS2: Study for the Review of the List of Restricted Substances - 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, Edma & Eucomed (2013): no title, January

62 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 existing equipment DINCH containing plastics can be treated as well as DEHP containing 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 manufacturers, importers and the authorities. The presence of DEHP cannot be determined by simple XRF screening, therefore sampling, extraction and laboratory 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 turnover 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 environmental (chemical analysis) industry. 62 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 plastics 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 creating 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 Additional investment costs for changing to other plasticiser in /kg Additional raw material + investment costs for DEHP or its alternative in /kg Additional raw material + investment costs for DEHP or its alternative in /y ,100,000 7,100,000 Additional costs for EEE producer in /y 0 no data available - Additional costs for waste treatment in /y 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. January

64 10 RATIONALE FOR INCLUSION OF THE SUBSTANCE IN ANNEX II OF ROHS Hazardous potential Nature and reversibility of the adverse effects Substance of very high concern DEHP is a substance of very high concern because of its toxicity to the reproductive system, the kidney and the liver. Data from animal studies and occupational exposure clearly demonstrate its adverse effects. Especially the effects on unborn babies are of major concern as they are believed to be long lasting effects. DEHP releases during WEEE treatment WEEE treatment compared to other waste treatment processes Releases from WEEE treatment compared to total DEHP releases The majority of environmental releases of DEHP from relevant WEEE treatment processes 57 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 products which remain in the environment after their use are estimated. In a scenario where emissions of particulates at shredder plants and cable shredders 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, incineration plants and uncontrolled treatment of WEEE i.e. treatment of WEEE in shredders, cable shredders and recycling of PVC In general, RAR DEHP provides little information on releases of DEHP containing products once they have become waste. 64 January 2014

65 Table 38: Summary of total DEHP emissions (Source: Table 3.37 of the RAR for DEHP, EC, 2008) January