Executive Summary

Inclusion of HBCDD, DEHP, BBP, DBP and additive use of TBBPA in annex IV of the Commission's recast proposal of the RoHS Directive

In response to the European Commission's 2009 proposal for a re-cast of the RoHS Directive on restrictions of certain hazardous chemical in electrical and electronic equipment (EEE), Denmark finds it relevant to consider the proposal of the inclusion of the following five substances under the proposed Directive's Article 4 (1) and Annex IV, rendering their respective use in electrical and electronic equipment restricted in the European Union:

Hexabromocyclododecane (HBCDD)
Bis (2-ethylhexyl) phthalate (DEHP)
Butyl benzyl phthalate (BBP)
Dibutyl phthalate (DBP)
Additive use of tetrabromo bisphenol A (TBBPA)

Certain aspects relevant to the inclusion in the RoHS Directive of these substances were assessed in a previous study by Öko-institut e.V. (Gross et al., 2008) for the European Commission, DG Environment. The report suggested all the substances for inclusion in the list of restricted substances in the RoHS Directive.

HBCDD, DEHP, BBP and DBP are (November 2009) included in the draft list of substances recommended by ECHA for inclusion in the list of substances subject to authorisation in Annex XIV of REACH. HBCDD has been proposed based on PBT properties (persistent, bioaccumulative and toxic) and the three others based on toxicity to reproduction.

The present study supplements the existing assessment with an assessment of socioeconomic impacts of the inclusion of these substances under the RoHS Directive.

An overview of possible types of socioeconomic impacts of inclusion of the substances under the RoHS Directive is given in the table 0.1 overleaf. Within the limits of this study, only selected impacts have been assessed further. Focus is on the estimation of the main net socioeconomic costs or benefit to the EU whereas the distributional effects (that some stakeholders have benefits while others have costs) are only described briefly.

Basically, the assessment compares:

The net costs to the society - expressed in terms of increased material costs (raw material cost, research and development (R&D) and investment in new tools and techniques) and increased costs of RoHS compliance (only assessed qualitatively).

with:
The benefits to human health and the environment of substitution - expressed in terms of differences in key environmental and health effects of the alternatives compared to the effects of the substances.

In order to set the estimated costs in perspective it may be relevant to look up some of the estimates in the Commission’s Impact Assessment for the recast of the RoHS Directive.

According to the Impact Assessment yearly administrative costs (in particular verification of compliance) make up approximately 67% of total costs, while the share of technical costs amounts to 33% (expected to drop to 12% in the future). The most important administrative cost is compliance verification, which is an ongoing expense. There are few data and many uncertainties about actual cost impact of the RoHS Directive, but the Commission estimated the total costs to be in the range of 165 to 23,000 million €/year, corresponding to 0.042 to 5% of the total turnover of EU companies affected by RoHS. Total turnover in EU companies in the EE sector is approximately 400.000 million €/year.

Estimation of benefits of reduced health and environment impacts by substituting the substances is still very immature and incomplete, and a quantitative assessment of these benefits has been beyond the limits of this study. For the comparison between the substances and alternatives, data on key effects have been summarised on the basis of existing reviews. The key effects considered are carcinogenicity, mutagenicity and toxicity to reproduction (CMR properties), as well as persistence, bioaccumulation, and toxicity (PBT properties). For most alternatives data are missing for some of the key effects, which is a common problem in socioeconomic assessment of substitution of chemicals as full data sets are normally not available for alternatives to substances considered for restriction. The question is whether the available data are considered sufficient for demonstrating that the alternatives most probably are less problematic than the substances considered for restriction.

Table 0.1
Impacts and costs elements of including the substances under the RoHS Directive

Stakeholders	Impact elements	Cost elements	Benefit elements
Manufacturers of the substance	Impact on producers of the substance	Decreased sale of the substance
	Impact on producers of alternatives	Costs of increasing the capacity for producing the alternatives	Income from increased sale of alternatives
Polymer converters (including formulators and some EEE manufacturers)	Impacts on polymer converters	One-time costs of adjusting polymer formulation and adapting/changing the process line
		Increased costs of polymers, flame retardants or plasticisers
	Impacts on working environment		Reduced costs of health effects from exposure to the substance and associated risk reduction efforts
EEE manufacturers	Impacts on EEE manufacturers	Increased costs of flame retarded plastic parts
		Administrative compliance costs of implementing RoHS
	Impacts on working environment		Reduced costs of health effects from exposure to the substance and associated risk reduction efforts
Consumers	Health impacts from exposure to the substance		Reduced costs of health effects from exposure to the substance
	Impacts on the price of EEE	Increased costs of EEE
Society	Impacts on public environmental enforcement	Costs for additional chemical analyses for compliance control
	Impacts on the environment		Reduced costs of environmental and health effects from exposure to the substance

HBCDD
The main concern regarding HBCDD is its persistence and toxicity in the environment as well as possible developmental neurotoxicity effects.

As regards human toxicity the main effect of concern is developmental neurotoxicity from exposure of the newborn child (neonatal exposure). The EU Risk Assessment Report concludes that there is a need for further information. The substance is currently not included in the list of classified substances. HBCDD is persistent in the environment and bio-accumulate and meets the PBT criteria.

The main application of HBCDD in EEE is as flame retardant in HIPS plastic used for closures and structural parts of different types of EEE. The total volume used for manufacturing processes within the EU is about 1,100 tonnes; no data are available on import/export with articles. HBCDD may as well be used in foams of EPS or XPS plastics in some EEE, but no actual use in EEE has been identified. The HBCDD has traditionally been used together with antimony trioxide (ATO), which is classified carcinogenic, but some HCBDD-based flame retardants, that can be used without ATO, have been introduced.

The use of HBCDD in EEE is not deemed essential as technically suitable alternative substances and materials are available and already used extensively today. The main alternatives are either HIPS with other brominated flame retardants (BFRs) or copolymers with phosphor esters.

Costs - At EU level the total incremental costs at the production level of replacing the HBCDD in HIPS in all EEE (both within and outside the scope of the RoHS Directive) are likely in the range of 1-10 million €/year if HBCDD is replaced with other BFRs and 5-25 million €/year if the HIPS/HBCDD is replaced by copolymers with non-halogenated flame retardants. The costs may decrease over the years as result of a larger market for the alternatives.

The main extra administrative costs is deemed to be related to compliance control, where the extra costs would mainly comprise the costs of analysis, as sampling and sample preparation will be done by the control of the flame retardants already restricted in RoHS.

Benefits - The available data indicates that a number of alternatives exists which do not meet the PBT criteria, and in this respect would probably be more environmentally friendly than HBCDD. The major uncertainly relates to data on human toxicity. Many of the alternatives have some demonstrated potential health effects. For most of the substances the available data do not indicate that the alternatives should be more problematic than the HBCDD as regards human health, but data are missing for critical endpoints.

DEHP
The main concern as to DEHP is its possible effect on reproduction. According to the EU Risk Assessment Report DEHP is bioaccumulative but is not considered a PBT substance or a vPvB (very persistent and very bioaccumulative) substance. With regard to CMR effects, DEHP raises concerns based on reproduction toxicity studies showing testicular effects, effects on fertility, toxicity to kidneys, on repeated exposure and developmental toxicity. DEHP is classified toxic to reproduction.

DEHP is mainly used in EEE as a plasticiser of flexible PVC used for wires, plugs, tubes and a number of other parts. It may in principle be found in nearly any EEE in small amounts. The exact consumption for EEE is not known, but it is likely that EEE marketed in the EU contain some 5,000-20,000 t/y of DEHP.

The use of DEHP in EEE is not deemed essential as technically suitable alternatives are available and already used extensively today. The main alternatives, which in recent years have taken over the major part of the former DEHP consumption, are the phthalates DINP and DIDP. If DEHP is restricted in EEE these alternatives will most likely take over a major part of the remaining uses. A number of non-phthalate alternatives are marketed, however, the price of these alternatives are in general somewhat higher.

Costs - It is estimated that the incremental material costs (at manufacturing stage) would be 0.5-2 million €/y (European prices) if DINP is used to substitute for DEHP in all EEE. In this case the R&D costs are assumed to be relatively low. The total costs of shifting to the cheapest of the non-phthalate plasticisers is higher and would likely be in the range 1-6 million €/y. Here R&D costs are higher. The actual costs depend on the share of the total EEE within the scope. The costs may decrease over the years as result of a larger market for the alternatives.

Substitution may result in slightly raised prices for flexible PVC parts in the EEE. For most EEE, the flexible parts which may contain DEHP comprise only a minor fraction of the equipment/product and represent only a minor part of the total production price of the product. Increases in consumer prices for the individual EEE as a result of a restriction of DEHP use in EEE are therefore expected to be small, but a restriction may impact a large share of all EEE.

Extra administrative costs are estimated to be related to compliance control, where the extra costs would comprise the costs of both sample preparation and analysis. The price of analysis for DEHP, DBP and BBP is nearly the same as for analysis of DEHP only.

Benefits - Available data for the alternatives indicate that with regard to human health effects less problematic alternatives exist. This conclusion is primarily based on data for repeated dose toxicity and existing reproductive toxicity data and it should be stressed that most of these alternatives are not fully investigated with regard to reproductive toxicity and in particular with regard to carcinogenicity. The environmental assessment of non-phthalate alternatives does not lead to the same conclusion, as most of the alternatives according to a recent (not yet published) study for the Danish EPA must be considered as more problematic for the environment than DEHP.

With regard to the phthalates DINP and DIDP, both substances show reproductive toxicity but at higher doses compared to DEHP. Also from an environmental point of view the two alternatives seem to provide a choice for more environmentally friendly alternatives based on the conclusions in the EU risk assessment reports.

DBP and BBP
The main concern as to DBP and BBP is the substances’ possible effect on reproduction and possible long-term adverse effects in the aquatic environment.

The substances are with regard to human health classified as toxic to reproduction. According to the EU Risk Assessments DBP and BBP are bioaccumulative and toxic to aquatic organisms, but not persistent in the environment. DBP and BBP are therefore not considered PBT substances or vPvB substances. With regard to CMR effects the Risk Assessments conclude, based on the available studies, that DBP and BBP are not considered genotoxic and are also not carcinogenic to humans.

The consumption of DBP for EEE production in the EU is likely in the range of 50-500 t/y mainly as secondary plasticiser in PVC and in adhesives and other non-polymer applications. The consumption of BBP for EEE production in the EU is likely in the range of 20-200 t/y; the BBP may be used in flexible or rigid PVC, sheets, adhesives, sealants and other non-polymer applications. The plasticisers may be present in a low percentage of products within all product categories. It has not been possible to fully confirm that DBP and BBP are currently used in the manufacture of EEE.

The use of DBP and BBP in EEE is not deemed essential as technically suitable alternatives are available and already used today for similar applications as the possible applications in EEE, however for some specific non-polymer applications substitution may be particular difficult. All available data indicate that alternatives exist, for example DGD, Benzoflex 2088 and ASE. For PVC softening, omitting the use of these secondary plasticiser may also be technically possible, although probably with increased PVC processing expenses as a consequence.

Costs - For most EEE, the parts which may contain DBP or BBP comprise only a minor fraction of the equipment/product and thus also only a minor part of the total production price of the product. Price differences between the substances and alternatives are approximately the same as for DEHP. As the consumption of the substances is only a few percent of the consumption of DEHP the increases in consumer prices for EEE, as a result of a restriction of the use of DBP and BBP use in EEE, are therefore expected to be minimal.

The main extra administrative costs are estimated to be related to compliance control, where the extra costs would comprise the costs of sample preparation and analysis. The price of analysis for DEHP, DBP and BBP is nearly the same as for analysis of DEHP. The scattered use of DBP and BBP in non-polymer applications in EEE may result in relatively high costs of compliance control, as relatively many samples have to be taken. For non-polymer applications compliance control will be particular difficult and will imply control of materials not otherwise controlled for other RoHS substances.

Benefits - Available data for the alternatives indicate that with regard to human health effects, less problematic alternatives exist. This conclusion is primarily based on data for repeated dose toxicity and existing reproductive toxicity data and it should be stressed that most of these alternatives are not fully investigated with regard to reproductive toxicity and in particular with regard to carcinogenicity.

With regard to endocrine disruptive effects DBP and BBP are on the EU list of substances with clear evidence of endocrine disrupting effects whereas none of the alternatives are on the list. Data for endocrine disrupting have not been available for evaluation in the recent Danish EPA assessment.

As for the environmental assessment of the alternatives the picture is not as clear, but three substances seem at least to be less problematic compared to DBP and BBP and these are DEGD, DINA, and GTA. The available data indicate that a number of alternatives exist which do not meet the PBT criteria, but for which more details and evaluation are necessary to conclude about their environmental effects compared to DBP. However, based on the Danish EPA assessment, DINA and GTA appear to be more environmentally friendly compared to DBP whereas the other 8 substances have positive responses for more than one of the effects: persistence, bioaccumulation and toxicity.

With regard to the overall assessment, the uncertainty concerning human health effects of alternatives, in particular reproductive toxicity and carcinogenicity, needs to be considered.

Additive use of TBBPA
The main concern regarding TBBPA is its toxicity in the aquatic environment and possible effects of breakdown products in the environment.

According to the EU Risk Assessment, TBBPA does not meet the criteria for being a CMR, a vPvB or a PBT substance. TBBPA is not on the Candidate List of SVHC substances currently proposed for inclusion in Annex XIV of REACH. When used additively TBBPA is used in conjunction with antimony trioxide (ATO) which is classified for carcinogenicity.

The main application of TBBPA used additively in EEE is in acrylonitrile-butadiene-styrene (ABS) plastic used for closures and structural parts of different types of EEE. The total content of additively used TBBPA in EEE marketed in the EU is estimated at some 8,000 tonnes/year assuming that 20% of the 40,000 tonnes/year in marketed EEE is used additively.

The additive use of TBBPA is not deemed essential as technically suitable alternative substances and materials are available and already used extensively today. The main alternatives for ABS/TBBPA/ATO systems are ABS with other brominated flame retardants and ATO or co-polymers (e.g. PC/ABS, PS/PPE, HIPS/PPO) with phosphate esters.

Costs - The prices of alternatives are typically 10-50% higher than ABS/TBBPA/ATO systems and it is estimated that the total incremental costs at the production level of replacing additively used TBBPA in all EEE may likely be some 5-30 million €/year depending on the actual alternatives being introduced (European prices). The costs may decrease over the years as result of a larger market for the alternatives.

The main extra administrative costs is estimated to be related to compliance control, where the extra costs would mainly comprise the costs of analysis as the sampling and sample preparation would be done in any case for control of the PBDEs in the parts.

Benefits - A number of alternatives to TBBPA exist which may potentially be less problematic than TBBPA, but data on the alternatives are missing for critical endpoints (e.g. carcinogenicity). Phosphate esters have been evaluated as promising alternatives to deca-BDE, but considering that TBBPA is neither a CMR, a vPvB nor a PBT substance, it may be considered necessary to have a more robust basis for decision on its inclusion in the RoHS directive.

RoHS vs. authorisation or restriction under REACH
HBCDD, DEHP, BBP and DBP are as mentioned included in the current draft list of substances recommended by ECHA for inclusion in the list of substances subject to authorisation under REACH.

The authorisation procedures only concern placing on the market or use of substances and do not address the import of articles containing the substances. In the case authorization is not granted for the application of the substances in EEE, European manufacturers will not be allowed to use the substances for manufacturing of EEE, whereas imported articles will not be affected.

If ECHA considers that the risk from the substances in articles (e.g. EEE) is not adequately controlled, the Agency shall prepare a dossier in relation to introduction of further restrictions and inclusion of the substances in Annex XVII of REACH. The restrictions specified in the Annex XVII concern placing on the market, manufacturing and uses of the substance on its own, in a mixture or in an article. The restriction would consequently also apply to imported EEE. By the restriction procedure a consumer safety can be achieved similar to the safety that can be achieved by inclusion of the substances in the list of prohibited substances in the RoHS Directive. The time perspective for a possible restriction in REACH of the use of the substances in EEE is unknown as no experience exist, but the procedure would probably take significantly more time than inclusion of the substances in Annex IV of the recast RoHS Directive.