Committee for Risk Assessment (RAC) Committee for Socio-economic Analysis (SEAC)

Transcription

1 Committee for Risk Assessment (RAC) Committee for Socio-economic Analysis (SEAC) Opinion on an Application for Authorisation for The use of chromium trioxide for functional chrome plating of piston rods for automotive and rail applications ECHA/RAC/SEAC: Opinion N AFA-O /D Consolidated version Date: 26/02/2018 Annankatu 18, P.O. Box 400, FI Helsinki, Finland Tel Fax echa.europa.eu

2 Consolidated version of the Opinion of the Committee for Risk Assessment and Opinion of the Committee for Socio-economic Analysis on an Application for Authorisation Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (the REACH Regulation), and in particular Chapter 2 of Title VII thereof, the Committee for Risk Assessment (RAC) and the Committee for Socio-economic Analysis (SEAC) have adopted their opinions in accordance with Article 64(4)(a) and (b) respectively of the REACH Regulation with regard to an application for authorisation for: Chemical name: chromium trioxide EC No.: CAS No.: for the following use: The use of chromium trioxide for functional chrome plating of piston rods for automotive and rail applications. Intrinsic property referred to in Annex XIV: Article 57 (a), (b) of the REACH Regulation Applicant: ZF Friedrichshafen AG Reference number: Rapporteur, appointed by the RAC: Co-rapporteur, appointed by the RAC: Rapporteur, appointed by the SEAC: Co-rapporteur, appointed by the SEAC: Susana VIEGAS Yvonne MULLOOLY Simon COGEN Derrick JONES This document compiles the opinions adopted by RAC and SEAC. 2

3 PROCESS FOR ADOPTION OF THE OPINIONS On 17/05/2017 ZF Friedrichshafen AG submitted an application for authorisation including information as stipulated in Articles 62(4) and 62(5) of the REACH Regulation. On 11/08/2017 ECHA received the required fee in accordance with Fee Regulation (EC) No 340/2008. The broad information on uses of the application was made publicly available at on 16/08/2017 Interested parties were invited to submit comments and contributions by 11/10/2017. The draft opinions of RAC and SEAC take into account the comments of interested parties provided in accordance with Article 64(2) of the REACH Regulation as well as the responses of the applicant. The draft opinions of RAC and SEAC take into account the responses of the applicant to the requests that the SEAC made according to Article 64(3) on additional information on possible alternative substances or technologies. The draft opinions of RAC and SEAC were sent to the applicant on 16/01/2018. On 26/02/2018 the applicant informed ECHA that they did not wish to comment on the opinions. The draft opinions of RAC and SEAC were therefore considered as final on 26/02/2018. ADOPTION OF THE OPINION OF RAC The draft opinion of RAC, which assesses the risk to human health and the environment arising from the use of the substance including the appropriateness and effectiveness of the risk management measures as described in the application and, if relevant, an assessment of the risks arising from possible alternatives was reached in accordance with Article 64(4)(a) of the REACH Regulation on 05/12/2017. The draft opinion of RAC was agreed by consensus. The opinion of RAC Based on the aforementioned draft opinion and in the absence of comments from the applicant, the opinion of RAC was adopted as final on 26/02/2018. ADOPTION OF THE OPINION OF SEAC The draft opinion of SEAC The draft opinion of SEAC, which assesses the socio-economic factors and the availability, suitability and technical and economic feasibility of alternatives associated with the use of the substance as described in the application was reached in accordance with Article 64(4)(b) of the REACH Regulation on 30/11/

4 The draft opinion of SEAC was agreed by consensus. The opinion of SEAC Based on the aforementioned draft opinion and in the absence of comments from the applicant, the opinion of SEAC was adopted as final on 26/02/

5 THE OPINION OF RAC The application included the necessary information specified in Article 62 of the REACH Regulation that is relevant to the Committee s remit. RAC has formulated its opinion on: the risks arising from the use applied for, the appropriateness and effectiveness of the risk management measures described, the assessment of the risks related to the alternatives as documented in the application, the information submitted by interested third parties, as well as other available information. RAC confirmed that it is not possible to determine a DNEL for the carcinogenic properties of the substance in accordance with Annex I of the REACH Regulation. RAC confirmed that there appear not to be any suitable alternatives that further reduce the risk. RAC confirmed that the operational conditions and risk management measures described in the application limit the risk, provided that they are adhered to along with the suggested conditions and monitoring arrangements. THE OPINION OF SEAC The application included the necessary information specified in Article 62 of the REACH Regulation that is relevant to the Committee s remit. SEAC has formulated its opinion on: the socio-economic factors and the availability, suitability and technical and economic feasibility of alternatives associated with the use of the substance as documented in the application, the information submitted by interested third parties, as well as other available information. SEAC took note of RAC s confirmation that it is not possible to determine a DNEL for the carcinogenic properties of the substance in accordance with Annex I of the REACH Regulation. SEAC confirmed that there appear not to be suitable alternatives in terms of their technical and economic feasibility for the applicant. SEAC considered that the applicant's assessment of: (a) the potential socioeconomic benefits of the use, (b) the potential adverse effects to human health of the use and (c) the comparison of the two is based on acceptable methodology for socio-economic analysis. Therefore, SEAC did not raise any reservations that would change the validity of the applicant s conclusion that overall benefits of the use outweigh the risk to human health, whilst taking account of any uncertainties in the assessment, provided that the suggested conditions and monitoring arrangements are adhered to. 5

6 SUGGESTED CONDITIONS AND MONITORING ARRANGEMENTS FOR REVIEW REPORTS The Applicant must continue to implement at least annual programmes of occupational exposure measurements relating to the use of Cr(VI) described in this application, consisting of personal and static air measurement as well as biomonitoring (as is currently the case). These monitoring programmes must be based on relevant standard methodologies or protocols and ensure a sufficiently low detection limit. The duration of sampling should be representative of all the tasks developed in the Worker Contributing Scenarios (WCS), (including tasks related to rare maintenance) with possible exposure to Cr(VI). The Applicant should include workers involved in WCS 7 (rare maintenance tasks) in the monitoring programme. The applicant should provide an analysis of the biomonitoring dataset, (including WCS 7), with sufficient contextual information on the workers involved in the sampling campaign, tasks performed and type of RPE/PPE worn to allow evaluation of the exposures. The information gathered in the monitoring programmes, including the biomonitoring data, shall be used by the Applicant to review the appropriateness and effectiveness of the risk management measures (RMMs) and operational conditions to further reduce workers exposure. The outcomes and conclusions of this review, including those related to the implementation of any additional RMMs, must be documented. The results of the monitoring and of the review of the OCs and RMMs must be maintained, be available to national enforcement authorities and included in any subsequent authorisation review report submitted. REVIEW Taking into account the information provided in the application for authorisation prepared by the applicant the duration of the review period for the use is recommended to be 12 years. 6

7 JUSTIFICATIONS The justifications for the opinion are as follows: 1. The substance was included in Annex XIV due to the following property/properties: Carcinogenic (Article 57(a)) Mutagenic (Article 57(b)) Toxic to reproduction (Article 57(c)) Persistent, bioaccumulative and toxic (Article 57(d)) Very persistent and very bioaccumulative (Article 57(e)) Other properties in accordance with Article 57(f): 2. Is the substance a threshold substance? YES NO Justification: Chromium trioxide has a harmonised classification as Carc. 1A; H350 and Muta. 1B; H340 according to Classification, Labelling and Packaging Regulation, (EC) 1272/2008. Based on studies which show its genotoxic potential, the Risk Assessment Committee (RAC) has concluded that chromium trioxide should be considered as non-threshold substance with respect to risk characterisation for carcinogenic effect of hexavalent chromium (reference to the studies examined are included in the RAC document RAC/27/2013/06 Rev. 1, agreed in RAC-27). 3. Hazard assessment. Are appropriate reference values used? Justification: RAC has established a reference dose-response relationship for carcinogenicity of hexavalent chromium (RAC/27/2013/06 Rev.1) which was used by the applicant. The molecular entity that drives the carcinogenicity of chromium trioxide (Cr(VI)) is the Cr(VI) ion, which is released when the substances solubilise and dissociate. Cr(VI) causes lung tumours in humans and animals by the inhalation route and tumours of the gastrointestinal tract in animals by the oral route. These are both local, site-of-contact tumours. There is no evidence that Cr(VI) causes tumours elsewhere in the body. Dose-response relationships were derived by linear extrapolation. Extrapolating outside the range of observation inevitably introduces uncertainties. As the mechanistic evidence is suggestive of non-linearity, it is acknowledged that the excess risks in the low exposure range might be an overestimate. 7

8 In the socio-economic analysis (SEA) the remaining human health risks are evaluated based on the dose-response relationship for carcinogenicity of hexavalent chromium (RAC27/2013/06 Rev.1). Are all appropriate and relevant endpoints addressed in the application? All endpoints identified in the Annex XIV entry are addressed in the application. 4. Exposure assessment. To what extent is the exposure from the use described? Description: Short description of the use ZF Friedrichshafen AG (ZF) is a downstream user of chromium trioxide Cr(VI) based in southwest Germany. This application for authorisation relates to functional chrome plating of piston rods. According to the applicant, Cr(VI) is needed to guarantee proper functioning of the damper system and with this the safe operation of a vehicle. ZF produces piston rods for automotive and rail vehicle damper systems in varying sizes(9 to 32mm). The process takes place in the applicant s facilities, at Eitorf and Schweinfurt. In 2015 ZF had 100-1,000 workers employed on the above mentioned two sites who were involved in the production of chrome plated piston rods. According to the applicant, the quantity of Cr(VI) used is below 100 tonnes per year. However, the majority of the Cr(VI) consumption at ZF is at the Schweinfurt site. In both facilities, functional chrome plating of piston rods can be divided into pre-treatment and main process. During pre-treatment, impurities are removed and the surface of the substrate is simultaneously activated (etching). In the main process, the actual chromium coating is created on the piston rod s surface. The pre-treatment and the main process are performed in consecutive Cr(VI)-containing plating baths where the parts are immersed in either an encapsulated or semi-closed 1 process and ZF operates encapsulated and semiclosed plating lines at their sites in Eitorf and Schweinfurt. The applicant claimed that both sites apply exactly the same procedures and emission controls. Because at the Schweinfurt site, the estimated air emission, as well as the estimated emission to wastewater, are higher than at Eitorf, the results for the Schweinfurt site are therefore used as a worst-case for assessing exposure. Exposure scenario The use is described in a single exposure scenario, concerning an industrial use at two sites as follows: Functional chrome plating of piston rods for automotive and rail applications The exposure scenario is comprised of eight Worker Contributing Scenarios (WCS) and one Environmental Contributing Scenario (ECS). According to the applicant, the exposure scenario includes all relevant processes and tasks associated with the use of Cr(VI) that could result in either environmental or human exposure. 1 For the meaning of the semi-closed please see a description of WCS 3 below. 8

9 Table 1: Contributing Scenarios presented in the CSR Contributing scenario ERC / PROC Name of the scenario ECS1 ERC 6b Functional chrome plating of piston rods for automotive and rail applications WCS 1 PROC 1 Delivery and storage of raw material (in solution) WCS 2 PROC 2 Functional chrome plating encapsulated plating line, closed process WCS 3 PROC 13 Functional chrome plating semi-closed plating process (only in Schweinfurt site) WCS 4 PROC 8b Sampling WCS 5 PROC 8b Adjustment in baths with aqueous solution of CrO3 WCS 6 PROC 28 Regular Maintenance WCS 7 PROC 28 Rare Maintenance WCS 8 PROC 8b Waste and wastewater management Worker exposure The worker exposure assessment has been limited to the inhalation of chromium trioxide containing dust and/or aerosols since the intrinsic hazardous properties of chromium trioxide is lung cancer due to inhalation. The applicant also assumed that all particles are in the respirable size range and, consequently, oral exposure was not assessed. Description of WCSs WCS 1: Delivery and storage of raw material (in solution) The CrO3 is delivered in a frost proof, heatable truck as an aqueous solution (the concentration of Cr(VI) in the mixture is below 30%) in sealed IBCs (Intermediate Bulk Containers) and is then stored in a locked, designated chemical storage cabinet. The sealed IBCs are transferred from the storage to the dosing station by a forklift. A maximum of two workers are involved in this task, one in each site. WCS 2: Functional chrome plating encapsulated, automated plating line, closed process In the encapsulated line, the jigs with the parts are moved in a predefined time through the different baths. The loading of the racks is conducted either by using a robot or by automated linear handling. The operator enters the encapsulated plant in the beginning of the first shift for a walk through and performs a few more walk-throughs per shift to undertake visual control assessments of the electrolyte. Additionally, the same operator conducts the visual control assessments of the plated rods and carries out preventive maintenance work inside the system, e.g. replacement of various small parts. In order to open the door of the housing, the operator has to press a specific request button that stops the plating activity inside and allows access into the area where baths are located. During the walk-through, the local exhaust ventilation is still in operation. Eight workers are involved in this WCS, four in each site. 9

10 WCS 3: Functional chrome plating semi-closed, automated plating process Functional chrome plating by dipping/immersion is conducted in sequential process steps within a series of tanks that contain treatment, cleaning, and other related solutions. Several tasks are involved including the manual loading of jigs with the parts to be plated. The jigs are automatically moved to the baths using a hoist. The jigs are automatically moved through the different baths in a closed trolley equipped with its own extraction. The plating steps include rinsing of parts, etching, chrome plating, and rinsing. Afterwards the jigs are automatically moved to a free position where parts are drained. Jigs are then manually unloaded from the racks by workers wearing gloves. After unloading, the treated parts are transported to the assembly line. The worker conducts a maximum of six control walks along the plating baths per shift. During the control walks, the local exhaust ventilation is still in operation. Ten workers are involved in the tasks of this WCS. WCS 4: Sampling Sampling is conducted for a limited time period (less than 5 min) when the automated plating lines are switched off but the LEV is still in operation. The worker enters the encapsulated or semi-closed plating lines production areas. One or more samples are drawn with a ladle at the bath(s) and then transferred in a closed flask to the laboratory. Workers are required to wear protective clothing, chemical resistant gloves and goggles. This task is performed once per week at Eitorf by laboratory technicians and daily in Schweinfurt by plant operators. Ten workers are involved in this WCS, five in each site. WCS 5: Adjustment in baths with aqueous solution of CrO3 This is done automatically. An IBC container is transferred from the storage to the dosing station of the respective plant by a forklift truck. A small plug is removed from the IBC and the IBC is equipped with a suction lance. Ten workers are involved in this WCS, five at each site. WCS 6: Regular Maintenance Regular maintenance is performed by plant operators from the plating department. Different tasks are undertaken for encapsulated lines and semi-closed lines. In the case of encapsulated lines, checks for tightness and leaks (piping, dosing pumps) and level monitoring of chemicals are performed. Once per week, numerous visual and tool-supported controls are done. Yearly, cleaning and greasing of several components is carried out The semi-closed lines maintenance implies that once per shift, the area around the semi-closed lines is cleaned manually with a brush and the plating lines are visually checked. Jigs are checked by visual control and with the help of tools once per month. The chromium and adjacent baths are checked, depending on the task, weekly, quarterly, twice a year or yearly. This includes the cleaning of chromic acid from baths and edges. The applicant clarified to RAC that the cleaning of chromic acid from the baths and edges is done using demineralised water once a week for a period of less than 10 minutes. Standard operating procedures are used, LEV is in operation during the activity and workers wear protective clothing. Seven workers are involved in this type of maintenance. 10

11 WCS 7: Rare Maintenance The tasks are performed by maintenance staff accompanied by the plant operator. In the same way as in WCS 6, standard operating procedures are used for different tasks in the case of encapsulated and semi-closed lines. For encapsulated lines, checking the anodes and cathodes and emptying the baths are performed twice a year. For cleaning and repair the chromium plating frame is removed from the bath. The intake is shut off and the heating of the bath is turned off. Membrane pumps are used to pump out the tanks to a buffer tank. Anodes are removed and cleaned. Getting into the chromium bath is only allowed according to instructions and with the use of Personal Protective Equipment (PPE). Rare maintenance can last 4 hours and when the LEV is off Respiratory Protective Equipment (RPE) is used. Additionally, the demister is maintained. For the semi-closed lines, maintenance of the scrubber is performed in different intervals. The tasks include, among others, the cleaning and changing of the filter and the yearly cleaning of the demister. The chromium and adjacent baths are regularly checked, including the inspection and changing of bath contacts. The worst case scenario for unplanned and rare maintenance is the possible demolition of a motor when a jig has accidentally plunged. A maximum of twenty one workers are engaged in this type of maintenance. WCS 8: Waste and wastewater management The process is fully automated and enclosed. Only sampling is performed manually and is executed before discharge of the treated effluent to the water, under national licence. Six workers are enrolled in this WCS. Description of RMMs/OCs in place According to the applicant, workers receive regular training with regard to chemical risk management and the safe use of PPE. The applicant also stated that regular housekeeping and management systems are in place ensuring high standards of operational procedure. The applicant also explained that the encapsulated chrome plating system (WCS 2) is installed above acid-resistant flooring and it is not operational when the doors are open. The system is equipped with a specific extraction system with filters and operated under negative pressure. Additionally, the piston rods are automatically loaded and unloaded into and from the jigs. The applicant clarified that the same type of flooring is installed in the semi-closed lines (WCS 3). The jigs are automatically moved through the different baths in a closed trolley equipped with its own extraction system. The jigs are then manually unloaded from the racks. Baths contain mist suppressants and are covered when not in use. Additionally, all the baths containing chromium trioxide or other hazardous substances are equipped with local exhaust ventilation during the treatment process. Moreover, in order to keep unauthorized staff away from the plating lines, the lines are secured via a lockable fence. Only authorized personnel wearing PPE have access to the semi-closed plating area. The applicant also clarified RPE is only used when LEV is turned off. Nevertheless, protective clothing, chemical-resistant gloves, and goggles are mandatory for tasks involving handling of the liquid formulation and unloading of jigs. 11

12 The applicant also indicated that mandatory preventive and follow-up occupational medical examinations for all employees including maintenance staff and health and safety responsible workers with potential exposure to hexavalent chromium have been conducted in the Schweinfurt site. A first follow-up examination has to be conducted within 6-12 months and then every months during employment. These examinations include, among others, general medical examination, pulmonary function test, and biomonitoring. After installation of the encapsulating line, examinations were ceased. However, a decision was made in 2016 to reintroduce the examinations and the biomonitoring program. Therefore, the latest biomonitoring data have been collected in Eitorf in December Exposure estimation methodology: Inhalation exposure: The exposure assessment for inhalation exposure provided by the applicant is based on a qualitative assessment (WCS 1), on results of workplace air monitoring campaigns for WCS 2 and WCS 3 (static and modelling) and on modelling for WCS 4, WCS 5, WCS 6, WCS 7 and WCS 8 using ART, version 1.5. In WCS 1, the applicant assumed that no exposure is expected considering the conditions of this task. RAC can agree with the applicant s assessment that exposure to chromium trioxide related to the delivery and storage of the solution is negligible. The exposure assessment for WCS 2 and WCS 3 is based on static and personal sampling developed at both sites with at least a 2 hour sampling period, which is considered by the applicant as representative of the full-shift. On RAC s request, the applicant clarified that sampling is undertaken by a certified institute and 2 hours was determined as sufficient time to be representative of the shift. The method used for analysis was the IFA 6665 and in some measurements, the sampling was performed using the method IFA For WCS 2, functional chrome plating in encapsulated plating lines, after a request for clarification by RAC, the applicant explained that eight of the static sampling results obtained on the 2 sites (2 from one site and 6 from the other) have sufficient sampling volume to show exposure levels below 1 μg Cr(VI)/m 3. The mean value of the samples obtained by static sampling (0.38 μg/m³) was considered by the applicant as best representing the whole dataset. The applicant justified their claim with more recent personal sampling performed from March and April 2017, with longer sampling times that followed the same trend of results. The applicant confirmed during the trialogue that measurements were below the LOD and they used 50% of the LOD for exposure estimation. Regarding WCS 3, functional chrome plating in semi-closed plating lines, all sampling results were below the LOD. In a more detailed manner, the applicant summarized the data and stated that two of the static sampling results had sufficient sampling volumes to provide results below 1 μg Cr(VI)/m 3 (< 0.6 and < 0.7 μg Cr(VI)/m 3 ). Additionally, the applicant mentioned that these values were confirmed by recent personal sampling with longer sampling time and considered that the available data set demonstrates negligible exposure potential for operators and therefore a value of 0.33 μg/m³ is used for exposure assessment as worst case assumption. The applicant also stated that the measured values already consider the effectiveness of the Local Exhaust Ventilation (LEV) in place. 12

13 During the trialogue the applicant explained that sampling performed for WCS 3 was done near the baths to follow a worst case approach. Additionally, the Applicant explained the calculations made to obtain the mean values of WCS 2 and WCS 3. For WCS 4 to WCS 8 no measured data were available and only modelled data was provided. However as WCS 4-5 is undertaken by the plant operators, and no adjustment for frequency was made for WCS 2 and WCS 3, the exposure during the WCS 4-5 along with the exposure during the daily tasks performed as part of WCS 6 is covered in the plant operator exposure assessment for WCS 2 and WCS 3. Input parameters for the model including OCs and RMMs have been provided in the CSR. For WCS 6 and WCS 7 (maintenance tasks), 2 sub-scenarios were defined for each WCS. These sub-scenarios consider different tasks. For WCS 7 no measured data was supplied even though this task is undertaken for a period of 4 hours without LEV (but with RPE). The applicant mentioned that, in one of the production sites, indirect exposure of bystanders is considered low since there is physical separation (by a rolling door) between the semiclosed plating lines and the encapsulated plating line and the general production. Table 2: OCs, RMMs and exposure assessment per WCS Description Duration & Freq. RMM Exposure assessment WCS 1 Delivery and storage of raw material (in solution) 20 min / day Storage cabinet with secondary containment and with an extraction system or in locked racks above secondary containment (coated flooring). Qualitative 0 μg/m 3 WCS 2 Functional chrome plating encapsulated plating line, closed process < 8 h / day Plant not operational when doors are open, during plant operators walk through. LEV PPE 0.38 μg/m³ Mean value obtained by static sampling from both sites WCS 3 Functional chrome plating semiclosed plating process < 8 h / day General ventilation: 5 air changes per hour LEV Separate room. PPE 0.33 μg/m³ Mean value obtained by static sampling from both sites WCS 4 Sampling Duration: < 8 min. Frequency: Eitorf - 1 / week, Schweinfurt - daily GMV: 10 ACH LEV (Fixed capturing hood 90%reduction) PPE μg/m³ ART 90 th perc. WCS 5 Adjustment in baths with aqueous solution of CrO3 Duration of activity: < 10 min Frequency of activity: < 1 time/week Automated PPE 0.14 μg/m³ ART 90 th perc. Adjusted for freq. (0.2) μg/m³ 13

14 WCS 6 Sub-scenario 1 Regular Maintenance 30 min / day for daily maintenance GMV: 3 ACH Fixed capturing hood (90.00 % reduction) PPE μg/m³ ART 90 th perc. Value used for risk assessment: 0.1 μg/m³ WCS 6 Sub-scenario 2 Regular Maintenance < 2h / week for the less frequent maintenance activities. GMV: 3 ACH Fixed capturing hood (90.00 % reduction) PPE 0.22 μg/m³ ART 90 th perc. Adjusted for freq. (0.2) μg/m³ Value used for risk assessment: 0.1 μg/m³ WCS 7 Sub-scenario 1 Rare Maintenance Duration of activity: < 4 hours Frequency of activity: < 1 time / month GMV: 3 ACH LEV (Fixed capturing hood % reduction) PPE 0.13 μg/m³ ART 90 th perc. Adjusted for freq. (0.05) μg/m³ Value used for risk assessment: μg/m³ WCS 7 Sub-scenario 2 Rare Maintenance Duration of activity: < 7 hours Frequency of activity: < 2 times / year GMV: 3 ACH PPE + RPE 2.4 μg/m³ ART 90 th perc. Adjusted for freq. (0.008) and RPE APF 30 (0.033) μg/m³ APF μg/m³ Value used for risk assessment: μg/m³ WCS 8 Waste and wastewater management < 10 min / day PPE All sludge is treated as hazardous waste & incinerated μg/m³ ART 90 th perc. - PPE: Protective clothing ((DuPont, Tychem C, Modell CH5), chemical-resistant gloves (Ansell, Bi-Colour, EN374), and goggles (Uvex Pheos). - RPE: Mask MOLDEX FFP3 APF 30 = 96.67% reduction following the German BG rule GMV-General mechanical ventilation - The values used for risk assessment are depicted in bold Dermal exposure: The applicant has not assessed dermal exposure in accordance with the RAC reference document which states that there are no data to indicate that dermal exposure to Cr(VI) compounds presents a potential cancer risk to humans (RAC27/2013/06 Rev. 1). The applicant did confirm that chemical resistant gloves are used when unloading rigs at the semi enclosed line and staff are trained in the safe use of PPE. Combined exposure: According to the applicant, workers in the functional chrome plating process at the sites may have some combinations of tasks (site specific). 14

15 The applicant stated that the highest combined exposure estimate would arise from the combination of WCS 2 (or alternatively, WCS 3), 4, 5, 6, and 7 which results in a combined exposure estimate of 0.52 μg Cr(VI)/m³. In section 6 the single cancer risk estimates for each WCS are listed as well as the combined exposure for WCS 2 to WCS 7. Uncertainties related to the worker exposure assessment: RAC addressed a number of perceived uncertainties in its questions to the applicant, related to: a) the robustness of the exposure assessment, b) the exposure of maintenance staff, c) the specifications and effectiveness of RPE, d) the duration of sampling for air measurements, and e) the necessity for providing contextual information to allow interpretation of the presented biomonitoring data. The responses given by the applicant were generally satisfactory and this section therefore only deals with any remaining uncertaitnies. The lack of monitoring data for WCS 7, undertaken by maintenance staff, is a notable source of uncertainty, since the workplace risk management measures such as ventilation and the duration of the tasks can greatly influence the level of exposure. After RAC s request for additional information related with maintenance WCSs, the applicant informed that they plan to include maintenance tasks in the future workplace measurement program. RAC requested the available biomonitoring data to complement the air monitoring dataset. The applicant presented data for each year (from 2012 to 2016) and the percentage of workers that obtained values of total Cr in urine below and higher than 0.6 μg/l. However, the applicant did not provide sufficient contextual information on the data (e.g. specific tasks performed before biomonitoring, group of workers involved in the sample campaign - maintenance or plating workers). During the trialogue, RAC requested additional information such as if the maintenance workers were enrolled in the biomonitoring campaigns and what were the locations of the workers that participated in the sampling campaigns. The Applicant clarified in their written answer that the workers of WCS 6 (regular maintenance) are included in the biomonitoring. The applicant also explained that the results are provided to the workers in writing (confidential) and if the measurement exceeded the guidance value, then remeasurements are conducted. If these re-measurements again exceed the guidance value, the line manager will be informed to discuss necessary provisions. However, the applicant explained that due to confidentially issues it is not possible to provide additional data. RAC acknowledges the applicant s good practice of implementing a biomonitoring programme and the use of the data to determine and reduce workers exposure. RAC also acknowledges that the occupational air monitoring and modelling dataset is robust and shows that the exposure is properly controlled. This conclusion reduces the above-mentioned uncertainty from the lack of contextual information on biomonitoring. Still, a summary analysis of the biomonitoring including contextual data should be included in the review report and made available to relevant national enforcement authorities (on request). 15

16 Environmental releases / Indirect exposure to humans via the environment The applicant considered that Industrial use of reactive processing aids (no inclusion into or onto article (ERC 6b) 2 is the most appropriate Environmental Release Category (ERC). RAC considers it likely that conversion products of Cr(VI) will be found in the surface layer and therefore notes that according to ECHA guidance on use description (R.12), processes where the substance, or its transformation products, are included into or onto an article are intended to be captured by ERC 5 3 (Use at industrial site leading to inclusion into/onto article). Estimation of releases The applicant stated that the majority of the Cr(VI) consumption is at the Schweinfurt site. Therefore, the estimated air and wastewater emissions are higher in Schweinfurt than in Eitorf. Considering this, the applicant used data from the Schweinfurt site as a worst-case approach. Release to air The applicant pointed out that due to its low volatility, chromium trioxide will not normally be present in the air. Nevertheless, energetic processes such as plating can release chromium trioxide into the air. To avoid this, the applicant informed that all workplaces with potential for release to air are equipped with exhaust ventilation systems to remove residual particulates. After that, the exhaust air is passed through wet scrubbers according to best available technique (minimum 99 % removal efficiency) before being released to the atmosphere. The applicant clarified that in Schweinfurt, exhaust air is pumped from the chrome bath to an atmospheric evaporator (volume flow according to the manufacturer: 9,000 m³ - 13,100 m³). The exhaust air is then transferred to the air scrubber (volume flow according to the manufacturer: 9,000 m³ - 13,100 m³) where it is transferred from the gaseous to the liquid phase. The exhaust air of the scrubber is then sucked into a condensate separator by a fan and is being released to the atmosphere via the roof. In case of the occurrence of any disturbances, the plating line is shut down via a feedback mechanism. Regarding the maintenance of the exhaust system, the atmospheric evaporator is more or less maintenance-free with the exception of regular visual control for deposits. Additionally, the applicant mentioned that the air scrubber is low-maintenance. In the case maintenance is performed, the plating line needs to be shut down beforehand. The applicant also indicated that the exhaust system installed in Eitorf is similar to the one in Schweinfurt and, therefore, the efficiencies are expected to follow the same trend and can be comparable. In the case of the semi-closed plating lines, the exhaust system is comparable to the one described for the encapsulated plating lines. In order to recover chromic acid and to clean the chromium containing exhaust air, each of the semi-closed lines is equipped with a 2 In recently revised ECHA guidance on use description (December 2015) ERC 6b refers to use of reactive processing aid at industrial site (no inclusion into or onto article). The previous version of R.12 referred to ERC 6b as Industrial use of reactive processing aids. The default worst-case release factors for environmental compartments for this ERC are unchanged as a result of this revision and are outlined in ECHA guidance on environmental exposure assessment (R.16). 3 In recently revised ECHA guidance on use description (December 2015) ERC 5 refers to use at industrial site leading to inclusion into/onto article). The previous version of R.12 referred to ERC 5 as Industrial inclusion into or onto a matrix. The scope of the ERC includes processes where the substance or its transformation products are included into or onto articles. The default worst-case release factors for environmental compartments for this ERC are unchanged as a result of this revision and are outlined in ECHA guidance on environmental exposure assessment (R.16). 16

17 separate horizontal exhaust air system including an evaporator and a scrubber. The three steps of exhaust air treatment comprise cooling of the electrolyte, scrubbing, and additional rinsing. Based on written clarifications following RAC ś request, the Applicant stated that for one site, emissions measurement reports are available for each year since The estimated value in the CSR ( mg/m 3 ) is the mean value for the years 2013 to 2016 based the highest reported emission values. At the other site, the value of mg/m 3 is the mean value of the measurements conducted in 2012 at all three emission sources and on the available measurements from 2013/2015, because not each of the point sources has been monitored in those years. All the mean values were based on the highest reported emission, therefore RAC agrees that a worst case approach was used. During the trialogue and after being requested by RAC, the Applicant provided further explanations and shared a detailed table with measurements which clarified the calculations. The Applicant explained in a written answer that the values were converted first into g/year using the total hours of operation and afterwards to kg/d. The emission at 100 m distance from point source was calculated using the relevant factor from the ECHA guidance document ( ). On a follow-up question by the RAC Rapporteurs on why there have not been measurements for all chimneys all of the given years, the Applicant clarified that according to the existing air emission licence, the frequency of measuring depends on the outcome of the first round of measurements, and the Applicant is only required to conduct these measurements every 3 years. Additionally, a justification was requested related to the differences in values observed across the chimneys, but no further explanations were provided. However, the Applicant emphasized that a worst-case approach was applied for the calculations and the maximum level from the emission measurements were used instead of the mean value. Release to water The Applicant explained that at both sites Cr(VI) containing wastewater from the chrome plating lines is first pumped to a specific collection tank and reduced to Cr(III). It is then, together with the residual concentrates and the rinsing water from the ion exchangers, passed through to the neutralization processes where the ph is adjusted in two steps (rough and fine neutralization). The following steps comprise the flocculation and clarification where the sludge is settled and pumped from the bottom of the tank to the sludge collection tank. The overflow is re-pumped into the rough neutralization tank or the flocculation tank. The purified water flows through the final control shaft where it is automatically monitored for ph value, chromium content, and turbidity, then directed to the on-site sewer system, and through the storm water sewage system into the nearest river, e.g. into the river Main in Schweinfurt. The Applicant also clarified that the water in the scrubbers is recycled and occasionally replaced, with resulting material being treated as waste in accordance with relevant waste management regulations. As stated by the Applicant, both sites are permitted to release 0.1 mg Cr(VI)/l based on national/local regulation. Cr(VI) content in wastewater is monitored before release to the public sewage system. The Applicant also mentioned that Cr(VI)emission to wastewater in 2014 and 2015 were on average around mg/l and 0.03 mg/l. After RAC s request, the Applicant also presented an example of the range of values of 6 measurements performed in These values ranged from < 0.01 to 0.05 mg/l. 17

18 On RAC s request, the Applicant also clarified that at the Schweinfurt site, Cr(VI) content in wastewater has to be determined and documented twice a week and at the Eitorf site 6 times/year. The analysis is conducted by accredited, certified external laboratories and with a detection limit for Cr(VI) of 0.01mg/l. Additionally, each wastewater discharge is monitored internally for Cr(VI) content. The average emission values were multiplied with the total yearly wastewater amounts for the sites and set in relation to the yearly amount of Cr(VI) used at the sites to estimate the release fraction to wastewater. The applicant s worst case assessment was based on the site with the largest use of Cr(VI). The Applicant also confirmed that there is a municipal STP for both sides, where the effluents are treated before their release to the different rivers. Release to soil The Applicant claimed that there are no direct releases of Cr(VI) to the soil. The sludge, resulting from the WWTP, after being thickened and drained is disposed of by an external service provider and handled as hazardous waste (i.e. incineration with only ash disposal to landfill). Regional exposure The exposure to man via the environment from regional exposure and the related RCRs are presented in the table below. The exposure concentration via inhalation is equal to the PEC air based on EUSES. Table 3: Regional exposure to man via the environment Route Regional exposure Risk characterisation Inhalation mg/m³ Based on the dose-response relationship for lung cancer mortality derived by the RAC, considering a 70 year exposure time (24 h/day, 7 d/week), the following excess lifetime lung cancer mortality risk for the general population is derived based on the estimated exposure: per 1,000 exposed. Oral Negligible The exposure to man via the environment from local exposure is presented in the table below. 18

19 Table 4: Local releases to the environment Release Release factor Release per year Release estimation method and details Air 0.018%* Eitorf mg/m 3 (mean value for 2013 to 2016) Schweinfurt mg/m 3 (mean value of the measurements conducted in 2012 and 2013/2015) ** Release factor based on the annual use of Cr(VI) Water Eitorf mg/l Schweinfurt mg/l Cr(VI) emission to wastewater in 2014 and 2015 were on average around mg/l in Eitorf and 0.03 mg/l Schweinfurt. These values were multiplied with the respective total yearly wastewater amount of the sites and set in relation to the yearly amount of Cr(VI) used at the sites to estimate the release fraction to wastewater. Soil * The release factor was estimated using tonnage and PEClocal information, provided by the site in Schweinfurt. ** Considered several years because not all the point sources have been monitored every year. Exposure estimation methodology: The Applicant provided an assessment of indirect exposure to humans via the environment at local scale based on EUSES modelling, version Table 5: Summary of indirect exposure to humans via the environment Protection target General population Inhalation (mg/m 3 ) General population Oral (mg/kg bw/day) Exposure estimate, EUSES, local scale * Drinking water Fish consumption Total ** * Estimated as the sum of Clocal air(annual average value) and PEC regional air and used as the basis for risk characterisation for man via the environment. **Accounting for the transformation of Cr(VI) to Cr(III) with a reduction factor of 97% (EU RAR 2005) 19

20 The Applicant considered the inhalation and oral exposure routes for exposure of the general population. Exposure via the oral route, however, has only been taken into account for drinking water and fish consumption. RAC acknowledges that Cr(VI) will transform rapidly in the environment to Cr(III) under most environmental conditions. This has been previously discussed in the EU RAR for chromate substances (EU RAR 2005). This will reduce the potential for indirect exposure to humans to Cr(VI) via the environment, particularly from the oral route of exposure. Accordingly, the EU RAR only assessed oral exposure to Cr(VI) as result of exposure from drinking water and the consumption of fish, rather than using the standard food basket approach that also includes contributions to oral exposure from the consumption of arable crops (root and leaf), meat and milk. RAC notes that the Applicant considers that the use is consistent with the environmental release category (ERC) 6b Use of reactive processing aid at industrial site (no inclusion into or onto article). Accordingly to ECHA guidance on use description (R.12) uses where a substance or its transformation products are included into or onto an article at industrial sites, such as the use described in this application, are intended to be captured by ERC 5. The default release factor to air for ERC 5 (50%) is considerably greater than the default release factor to air for ERC 6b (0.1%). However, since monitoring data are available, the choice of the initial release factor does not have any impact on the applicant s exposure assessment. Uncertainties related to the assessment of exposure to humans via the environment: RAC notes the efforts made by the Applicant to calculate the regional indirect exposure of humans via the environment. RAC acknowledges that Cr(VI) will transform in the environment to Cr(III), which has been previously described in the EU RAR for chromate substances (EU RAR 2005). This will reduce the potential for indirect exposure to humans via the environment after release and for the oral route of exposure (on this basis, the EU RAR only included oral exposure from drinking water and the consumption of fish). In view of this, RAC notes that the exposure estimates generated most likely overestimate the actual exposure. Conclusion RAC considers that: - The description of use provided allows conclusions to be drawn related to exposure of workers and the environment; - The methodology used and the information provided, related to exposure resulting from the use applied for, are sufficient for use in the risk assessment; - RAC considers that the representativeness of the exposure assessment would be greater if based on measured data for, particularly, WCS 7 (rare maintenance); better contextual information on biomonitoring of workers would also assist any review report submitted by the applicant; - Estimates of local release to air and water are considered adequate, as they are based on measured data which is available for both sites. Overall, the uncertainties identified are considered to be relatively minor and do not invalidate the Applicant s exposure assessment. 20

21 5. If considered a threshold substance, has adequate control been demonstrated? YES NO NOT RELEVANT, NON THRESHOLD SUBSTANCE 6. If adequate control is not demonstrated, are the operational conditions and risk management measures described in the application appropriate and effective in limiting the risk? YES NO Justification: Evaluation of the Risk Management Measures RAC notes that plating occurs in either an encapsulated process or a semi-closed process. Both processes are equipped with LEV. For the semi-closed baths partial coverage of the baths is used during treatment as a technical means to minimize concentrations of Cr(VI). Regarding the LEV in place, the Applicant mentioned that the functionality of the LEV systems at all plating units is controlled electronically, that the systems are well maintained,that all users are trained and instructed to use the LEV correctly and to report any defects observed. Additionally, the Applicant informed that supervisors are required to keep a record of regular checks on their LEV systems. In the CSR the Applicant did not provide the frequency or the type of verifications done to the LEV systems. After RAC s request for additional information the Applicant clarified that for the encapsulated lines, a lip extraction is integrated in the installation and efficiency is checked weekly by volumetric flow measurements and tested externally one time per year. The semi-closed plating lines are also equipped with lip extraction and efficiency is checked weekly by volumetric flow measurements. According to information in the CSR, access to all chrome plating areas is restricted to authorised personnel, Standard Operating Procedures (SOPs) are in place and workers receive regular training with regards to chemical risk management and how to properly wear the PPE. The Applicant also stated that protective clothing, chemical-resistant gloves, and goggles are mandatory for those tasks involving handling of the liquid formulation. Additionally, Respiratory Protection Equipment (RPE) is available for workers in WCS 7 (during the performance of specific tasks). After being requested by RAC, additional information was given regarding the RMMs and OC in place for some specific tasks developed in WCS 6 and WCS 7. If the task has to be developed without LEV under hot process conditions (worst case scenario) the workers have to use RPE without exceeding 60 minutes until a break in the work occurs. However, this can happen several times until the tasks have been concluded. 21