Socio-economic analysis in REACH restriction dossiers for chemicals management: A critical review.

This paper offers a critical review of socio-economic analysis (SEA) in Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) restriction dossiers. We examine the conceptual setup of SEA and identify the methods used for impact assessment. Moreover, we analyse the outcomes of quantitative impact assessment across restriction dossiers and substance groups. We find that impact assessment has largely focused on economic and health impacts. Environmental, social, wider economic and distributional impacts have either been evaluated qualitatively or not at all. While this can be explained by the specific scope of the proposed restriction or by lacking data, we also observe a lack of approaches for environmental and health impact assessment. This underlines the need to develop integrated methods that transform information about chemical effects and risks into impacts and, ultimately, into benefits and damages. Furthermore, to strengthen the function of SEA as decision-support tool in REACH restriction procedures, a comparative SEA of at least two alternative restriction options should be the default. Electronic supplementary material The online version of this article (10.1007/s13280-019-01285-9) contains supplementary material, which is available to authorized users.

: Basic information of 24 REACH Annex XV restriction dossiers † (substance name, CAS number, submitting authority, SVHC classification), baseline scenario and risk management options (RMOs) specified by the dossier submitter, and regulatory decision adopted by the European Commission. RMO 4: Ban on Pb and its compounds in fashion jewellery which are used and placed on the market; RMO 5: Ban on Pb and its compounds in some fashion jewellery which are used and placed on the market; RMO 6 (proposed and preferred option): Restriction on the use and placing on the market of jewellery (fashion and precious) based on the Pb migration rate; RMO 7: Restriction on the use and placing on the market of jewellery (fashion and precious) based on the Pb content and the Pb migration rate.
Adoption of RMO 2, with modification as suggested by RAC/SEAC: Pb concentration being equal or greater than 0.05% by weight. Total annual amount of Hg in measuring devices for industrial and professional uses placed on the market (as approximation of the maximum emission potential) 13-63.4 t/y.

RMO 1 (proposed and preferred option):
Hg containing barometers, hygrometers, manometers, sphygmomanometers, strain gauges, tensiometers, thermometers and other non-electrical thermometric applications shall not be placed on the market after 18 months of restriction entering into force; Alternative RMOs defined for some measuring devices. Decrease of emissions to waste water from 2010 to 2015 due to assumed reduction in emissions from other sources than textiles in combination with improved WWTP's c , but increase of emissions from 2015 to 2031 due to an assumed growth in emissions from imported textiles. Emissions of NP/NPE to surface water are considered to remain relatively stable.

RMO 1 (proposed and preferred option):
Restriction of NP/NPE use in textile articles, or textile parts of articles, above a concentration limit of ≥ 0.01% by weight and with a transitional period of 5 years; RMO 2: NPE Limit value < 0.01% by weight for textile articles, or textile parts of articles, with a transitional period of 5 years.

RMO 1 (proposed and preferred option):
Modification of the current entry 23: Restriction on the placing of the market of paints containing Cd with concentration limit of ≤ 0.01%; RMO 2: Restriction on the placing of the market of paints containing Cd with concentration limit of ≤ 0.01%, with derogation for copper-based antifouling paint with concentration limit of ≤ 0.0175%.

RMO 1 (proposed option):
Continuation of the current derogation from prohibiting the manufacture, placing on the market and use of chrysotile fibres and of articles and mixtures containing these fibres with timelimited exemptions of national legislations (10 years). Exemption can be renewed; RMO 2 (preferred option): Derogation from prohibition with a fixed end date (2025) as specified in entry 6. Exemptions can principally be extended via a regular Annex XV restriction procedure.
RMO 3: Same as option 2, but additional specification of a volume constraint for the exemption.  A growing market of thermal paper  An expected 'spontaneous' decrease in the use of BPA in thermal paper  An already underway substitution of BPA by alternative developers in thermal paper

RMO 1 (proposed and preferred option):
Limitation of BPA in thermal paper to concentrations equal or smaller than 0.02% by weight, by either switching to substitute BPS f or to non-bisphenol alternatives. The transitional period proposed for the entry into force is 3 years; RMO 2: Limitation of the migration of BPA in thermal paper into coat thermal paper to avoid absorption by contact. Proposed restriction: MeOH shall not be placed on the market for supply to the general public as a constituent of windshield washing fluids (including windshield defrosters) in concentration ≥ 3.0% by weight, and -as an additive to denaturated alcohol (methylated spirit, denaturated alcohol, brennspiritus) in concentrations ≥ 3.0% by weight Adoption of the proposed restriction with stricter concentration limit (0.6% by weight) as proposed by SEAC. yes Current surface water emissions estimated at <5 t/y for D4 and <500 t/y for D5 (despite a high WWTP e removal efficiency). Releases are widely distributed in EU environment.

RMO 1 (proposed and preferred option):
Restriction on placing on the market and use of wash-off PCPs g containing > 0.1% w/w D4 or D5 with a compliance period of 2 years; RMO 2: Restriction on placing on the market and use of wash-off PCPs containing > 0.1% w/w D4 or D5 with a compliance period of 5 years. Based on an estimate of 5.2 million workers exposed to isocyanates in all sectors (construction chemicals, automotive repair, other sectors), with a prevalence of 10%, the estimated number of new cases of occupational asthma in the EU is 6,500 persons/y.

RMO 1 (proposed and preferred option):
Implementation of restrictive conditions of use, mainly affected are workers who are at high risk, exemptions for workers at low risk; RAC/SEAC opinions adopted, Commission decision-process still on-going.
2 Phenyl-Hg Exponential discounting, r = 4% applied to costs of restriction options 2010-2028 Discussion of parameter uncertainties (related to emission estimates, cost estimates, import of articles, benefits of the restriction) and scenario uncertainty (definition of Phenyl-Hg decline in baseline scenario, future trends on export markets).
No quantitative uncertainty assessment.

Hg in measuring devices
Exponential discounting, r = 4% applied to costs of restriction options 20 years Discussion of parameter uncertainty (release fractions, time period for SEA assessment, spill response, disposal of measuring devices, technical feasibility of alternatives).
Scenario analysis of compliance costs (high and low cost scenario) based on different estimates for mercury spill responses. 4 Phthalates (2012) No discounting applied. Not specified Discussion of parameter uncertainty (exposure estimates, risk characterisation ratio, biomonitoring data, migration of phthalates in articles, number of articles, number of importers, substitution costs).
Sensitivity analysis of substitution costs (variation of phthalate content in articles and of expected outcomes of the authorisation process).

5
Cr VI Exponential discounting of costs and benefits, r = 4% 20 years Sensitivity analysis of cost and benefit estimates (variation of prevalence of chromium allergies, expected effect of the proposed restriction, welfare and industry costs). Additional sensitivity analyses provided by SEAC.
6 DCB Exponential discounting of costs and benefits, r = 4%. 20 years Sensitivity analysis (variation of assumed shape of demand curve (linear, non-linear), different price elasticities of demand, value of capital equipment regarding different discount rates).
Exponential discounting of costs and benefits, with sensitivity analysis for assessing discounted lifetime productivity loss.

Lifetime
Discussion of legal and parameter uncertainties. Scenario analysis of exposure scenario (revealing a high and low value of expected IQ loss), and of expected compliance costs and benefits (high, medium and low values of additional testing costs, substitution costs, costs for re-design, lead content in consumer articles, reduction of lifetime earnings due to IQ loss, discount rate applied to lifetime earnings).

NP/NPE
Exponential discounting of costs, r = 4% 2010-2021 Discussion of scenario and parameter uncertainty. Scenario analysis of emission reduction capacity and cost estimates distinguishing high, mean and low parameter estimates.

years
Discussion of legal and parameter uncertainty (DALY b values, number of people exposed, cost estimates). Sensitivity analysis (variation of number of workers exposed (values not published)).

Cd in paints
No discounting applied.
---Discussion of uncertainty in estimates of Cd content.

Cd in artists' paints
Exponential discounting, using different discount rates for benefit (r = 3,5% and 2%) and cost estimates.

years
Explorative discussion of parameter uncertainty (Cd deposition, Cd concentrations in food categories, Cd concentrations in agricultural soils, effects of Cd exposure; scenario analysis of cost calculations (using different implementation time periods) and benefits (varying the values of the economic growth rate, the pure time preference rate, the length of the first generation in discounting, the direct cost growth rate and the monetary value per QALY c ).
12 CHRY Exponential discounting of costs and benefits, r = 4%. 2015-2025 Scenario analysis of costs (high and low cost estimates), assuming different rates of output and, production efficiency and time durability of the new technology.

13
DMFu No discounting applied. Not specified Discussion of parameter uncertainty (number of people exposed, probability to suffer from dermatitis, costs of the use of an alternative substance, medical costs, loss of productivity, refund costs of articles).
14 BPA Exponential discounting of benefits, using different discount factors for early and late benefits (r = 2% and 0%), exponential discounting of costs, r = 4%. Discussion of parameter uncertainty (number of people exposed, volume and trends of export and import flows, health and environmental risks of alternative formulations). Sensitivity analysis (variation of selected parameters of cost and benefit estimates). Discussion of main uncertainties (number of poisoning incidents, total number of spray products, threshold concentration value). Scenario analysis for consumer exposure, reformulation costs (conducted by SEAC).

21
Phthalates 2017 Exponential discounting of costs and benefits, r = 4%. 20 years Discussion of parameter uncertainties (material costs, testing costs, substitution costs, costs of recycling, human health impacts) and scenario uncertainties (future tonnage, transition time to alternatives). Scenario analysis (high and low tonnage value in baseline, high and low material and testing costs, high and low transition period on cost-effectiveness, impact of combined uncertainties on cost-effectiveness). Sensitivity analysis (variation of infertility cases on health damage costs).

22
Diisocyanates Exponential discounting of costs and benefits, r = 4%. 20 years Discussion of parameter uncertainties (prevalence of asthma, age of asthma sufferers) and uncertainty due to lack of knowledge (other health effects except asthma; sensitivity analysis of cost estimates assuming high and low values for test exemption costs and training options.

23
Pb-PVC Exponential discounting of benefits, r = 4% Year of implementation (2016) Sensitivity analysis of cost-effectiveness value, exploring the variation of the percentage of restriction-induced costs passed on to consumers on compliance costs and cost-effectiveness ratio.

24
PB in shot Exponential discounting of replacement costs, r = 4%.

year transitional period
Replacement period shotguns 50 and 20 years, respectively Discussion of parameter uncertainties (fraction of hunting taking place in wetlands, number of hunters involved in hunting on peatlands, number of guns to be replaced, lead emissions, annual number of waterbirds dying).
Scenario analysis (best, central and worst-case cost estimates and estimates of hunters affected).