Chemical Safety Report

CHEMICAL SAFETY REPORT

Functional chrome plating with decorative character for sanitary applications (Use 1)

This document shall not be construed as expressly or implicitly granting a license or any rights to use related to any content or information contained therein. In no event shall applicant be liable in this respect for any damage arising out or in connection with access, use of any content or information contained therein despite the lack of approval to do so.

Substance Name: chromium trioxide

EC Number: 215-607-8

CAS Number: 1333-82-0

Applicants Identity: Aloys F. Dornbracht GmbH & Co. KG

Copy right protected - Property of Aloys F. Dornbracht GmbH & Co. KG - No copying / use allowed EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

9. EXPOSURE ASSESSMENT (and related risk characterisation) 9.0. Introduction This exposure assessment aims to provide reliable estimates of current work place exposure level at the applicant’s facility in Iserlohn Germany. Occupational work place exposure to hexavalent chromium [Cr(VI)] is regulated in most European countries. National Occupational Exposure Limits (OELs) across Europe respect a range of 8 hour Time Weighted Average (TWA) values between 1 µg/m3 and 50 µg/m3. The US Occupational Safety and Health Administration (OSHA) OEL is at 5 µg/m3. In 2014, France introduced a new OEL of 1 µg/m3. This is one of the most stringent OEL currently in place anywhere in the World and compliance requires substantial research and investment. In Germany, the evaluation standard is 1 µg/m3. Chromium (VI) compounds have been included in Annex I to Directive 2004/37/EC - carcinogens or mutagens at work, last amended by Directive (EU) 2017/2398 of the European Parliament and of the Council of 12 December 2017 with a transitional occupational exposure limit of 10 µg /m3 until January 2025 (after that 5 µg /m3). The Carcinogens and Mutagens Directive (2004/37/EC) requires each Member State to ensure employers reduce and replace use of hexavalent chromium substances, and the introduction of a new OEL in France provides one clear example of regulation by Member States to effect a reduction in workplace exposure to Cr(VI). Industry is proactively engaged in delivering continuous reduction through the development and implementation of appropriate RMMs. Best practice across the industry is continually improving, driven by general awareness of workplace hygiene and increasingly stringent regulatory requirements. This commitment to reducing exposure also reflects the widespread recognition that surface treatment including coating with Cr(VI) is critical for several industries and that alternatives are not available in the near-term. 9.0.1. Overview of uses and Exposure Scenarios

Tonnage information:

Assessed tonnage: 1-10 tonnes …. chromium trioxide/year [containing approximately 1-10 tonnes …. Cr(VI)]

The following table lists all the exposure scenarios (ES) assessed in this CSR.

Table 6. Overview of exposure scenarios and contributing scenarios Identifiers Market Titles of exposure scenarios and the related contributing Tonnage Sector scenarios (tonnes per year) ES1 – IW1 Use at industrial site – Functional chrome plating with decorative 1-10 character for sanitary applications [approx. 1-10 - Functional chrome plating with decorative character for sanitary Cr(VI)] applications (ERC 6b) - PROC 1: Delivery and storage of raw material - PROC 4: Connecting IBC to pumping system - PROC 4: Loading and unloading of jigs - PROC 2: Automatic plating lines - PROC 13: Manual plating process - PROC 8b: Sampling - PROC 8b: Concentration adjustment in baths with aqueous solution of CrO3 - PROC 28: Regular Maintenance - PROC 28: Rare Maintenance - PROC 8b: Waste and wastewater management Industrial end use at site: IW-#

CHEMICAL SAFETY REPORT 16

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

9.0.2. Introduction to the assessment

9.0.2.1. Environment

Scope and type of assessment

The current Chemical Safety Report (CSR) and the associated exposure scenarios are tailored to support the Application for Authorization (AfA) to continue use of chromium trioxide for the use of functional chrome plating with decorative character for sanitary applications after the sunset date in September 2017.

Chromium trioxide has been included in Annex XIV to Regulation (EC) No 1907/2006 ('REACH') due to its intrinsic properties as being carcinogenic (Carc. 1A) and mutagenic (Mut. 1B).

Following REACH, Article 62(4)(d), the CSR supporting an AfA needs to cover only those potential risks arising from the intrinsic properties specified in Annex XIV. Accordingly, only the potential human health risks related to the classification of chromium trioxide as a carcinogenic and mutagenic toxicant are considered in the current CSR. The dominating health effect resulting from the intrinsic hazardous properties of chromium trioxide is lung cancer due to inhalation of dust and/or aerosols.

Evaluation of any potential hazards to the environment is not required within the framework of this authorisation application. Health hazards may potentially relate to Cr(VI) exposure of the general population via the environment and are considered accordingly.

Measures to prevent or limit release of Cr(VI) to the environment are provided as best practice at facilities carrying out operations using chromium trioxide. During industrial surface treatment operations, prevention of releases of substances to the aquatic environment is a matter of good practice. In general, treatment technology (on-site or off-site) to reduce Cr(VI) to trivalent chromium [Cr(III)] in wastewater is generally highly effective, such that residual concentrations of Cr(VI) in effluent are very low and often non-detectable and may be considered negligible. The exact process of wastewater treatment at the site is further described in section 9.1.1. Solid and liquid waste containing Cr(VI) is collected and treated as hazardous waste where residual Cr(VI) can be effectively safely treated. In view of the RMMs in place at the production facilities, emissions to the aquatic environment associated with surface treatment operations are effectively prevented.

Due to its low volatility, chromium trioxide will not normally be present in air. Nevertheless, energetic processes (e.g. plating) can release chromium trioxide into air. All workspaces with potential release to air are equipped with exhaust ventilation systems to remove residual particulates: exhaust air is passed through wet scrubbers according to best available technique before being released to atmosphere. In Iserlohn, exhaust air is pumped from the chrome bath to an atmospheric evaporator where it is spread. The spread exhaust air is then transferred to the air scrubber where it is transferred from the gaseous to the liquid phase. The exhaust air 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 maintenance of the exhaust system, the atmospheric evaporator is almost maintenance-free with the exception of regular visual control for deposits. The air scrubber is low-maintenance, every four weeks a water exchange is performed. In case when maintenance is performed, the plating line needs to be shut down beforehand.

While emissions to air are therefore very low, they have been considered in this assessment as a factor potentially contributing to Cr(VI) exposure of humans via the environment. The scope and type of the assessment of the pathway “man via the environment” is discussed in section 9.0.2.2 below.

CHEMICAL SAFETY REPORT 17

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

Example of the exhaust system of the encapsulated plating lines.

Cr(VI) is neither directly nor indirectly released to soil due to adequate technical and organizational measures and therefore releases to soil are considered negligible.

Table 7. Type of risk characterisation required for the environment Protection target Type of risk characterisation Hazard conclusion (see section 7) Freshwater Not required Not relevant Sediment (freshwater) Not required Not relevant Marine water Not required Not relevant Sediment (marine water) Not required Not relevant Sewage treatment plant Not required Not relevant Air Not required Not relevant Agricultural soil Not required Not relevant Predator Not required Not relevant

Comments on assessment approach: In accordance with REACH, Article 62(4)(d), potential risks to the environment need not be considered.

9.0.2.2. Man via environment

Scope and type of assessment As discussed in 9.0.2.1., humans may potentially be exposed to chromium trioxide via the environment. Since strict emission control measures are implemented, releases to the aquatic environment (and also to soil), if any, are negligible, and the only relevant potential exposure path is inhalation, and expressed as Cr(VI).

CHEMICAL SAFETY REPORT 18

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

Table 8. Type of risk characterisation required for man via the environment Route of exposure Type of risk characterisation Hazard conclusion and type of effects (see RAC/27/2013/06 Rev.1) Inhalation: Local long- Quantitative Lung cancer: term ELR = 2.9E−02 per μg Cr(VI)/m³ for 70 years Oral: Local long-term For inhalation of particles: not needed. Assume all Intestinal cancer: inhaled material is respirable (worst case). ELR = 8.0E−04 per μg For food chain: Quantitative Cr(VI)/kg bw/d for 70 years

Comments on assessment approach: The risk assessment for humans exposed via the environment is restricted to inhalation of airborne residues of chromium trioxide. The oral route (swallowing of the non-respirable fraction) does not need to be explicitly considered since: (i) the exposure calculations (airborne concentrations) do not provide different particle size fractions (inhalable/thoracic/respirable); (ii) the excess lifetime risk (ELR) for intestinal cancer is one order of magnitude lower than that for lung cancer. The assessment of health impacts is therefore dominated by the potential risk of lung cancer due to inhalation of Cr(VI); (iii) the document on a reference dose-response relationship for Cr(VI) compounds (RAC/27/2013/06 Rev.1) states that “in cases where the applicant only provides data for the exposure to the inhalable particulate fraction, as a default, it will be assumed that all particles were in the respirable size range.” Therefore, in accordance with the above findings and provisions on the risk assessment for humans exposed via the environment, since it is assumed that all particles are in the respirable size range, no exposure via the oral route due to inhalation of particles needs to be considered. This constitutes a worst-case approach, since the potential lung cancer risk is an order of magnitude higher compared to the potential intestinal cancer risk, based on the dose-response relationships agreed by RAC. Food chain through drinking water and fish is assessed quantitatively.

CHEMICAL SAFETY REPORT 19

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

9.0.2.3. Workers

Scope and type of assessment

The scope of exposure assessment and type of risk characterisation required for workers are described in the following table based on the hazard conclusions presented in section 5.11.

Table 9. Type of risk characterisation required for workers Route Type of effect Type of risk characterisation Hazard conclusion (see RAC/27/2013/06 Rev.1) Systemic long-term Not needed Systemic acute Not needed Not relevant Local long term Quantitative Lung cancer Inhalation ELR = 4.0E−03 per μg Cr(VI)/m³ for 40 years Local acute Not needed Not relevant Systemic long term Not needed Not relevant Systemic acute Not needed Not relevant Dermal Local long term Not needed Not relevant Local acute Not needed Not relevant Eye Local Not needed Not relevant

Comments on assessment approach related to toxicological hazard:

Chromium trioxide has been included into Annex XIV to REACH due to its intrinsic properties as being carcinogenic (Carc. 1A) and mutagenic (Mut. 1B).

Following REACH, Article 62(4)(d), the CSR supporting an AfA needs to cover only those potential risks arising from the intrinsic properties specified in Annex XIV. The dominating health effect resulting from the intrinsic hazardous properties of chromium trioxide is lung cancer due to inhalation of dust and/or aerosols.

Exposure estimates generated by ART 1.5., or measured values are given in terms of Cr(VI) and are expressed as 8 hour Time Weighted Average (TWA).

The oral route (mucociliary clearance and swallowing of the non-respirable fractions) is not taken into account for the same reasons as already explained in the context of “man via environment” (section 9.0.2.1 above). In accordance with the RAC document on the dose-response relationship (RAC/27/2013/06 Rev.1), it must be assumed that all particles are in the respirable size range. Hence, no exposure via the oral route needs to be considered.

Comments on assessment approach related to physicochemical hazard:

Not relevant – physicochemical hazards are not subject of this CSR.

CHEMICAL SAFETY REPORT 20

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

General information on risk management related to toxicological hazard:

The Exposure Scenarios specify OC and RMM employed by the Dornbracht facility carrying out good practice to minimise exposure. The site must ensure that the controls which they have in place provide an equivalent or better level of protection than those set out in the Exposure Scenario.

The following risk management measures are in place

• 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 Personal Protective Equipment (PPE).

Potential exposure of workers handling chromium trioxide is restricted to the lowest possible level.

Aqueous solutions of chromium trioxide are expected to entail only a low potential for generating mists, not requiring Respiratory Protective Equipment (RPE). However, in case of maintenance activities RPE is worn from the respective workers involved in the respective process. Nevertheless, protective clothing, chemical- resistant gloves, and goggles are mandatory for those tasks involving handling of the liquid formulation. Examples of gloves, respiratory protective equipment, goggles and safety clothing which are used at Dornbracht are shown below.

As already mentioned earlier, operators are trained in the safe use of PPE. For determining the efficiency of RPE, the German BG rule “BGR/GUV-R1902 was used because it provides a robust and consistent approach. Another approach could equally have been used. In any case, such approaches rely on the assigned protection factor (APF) for RPE that may or may not be based on actual workplace measurements under relevant or non-relevant conditions. The German BGs, especially its Institute for Occupational Safety and Health (IFA) is an internationally highly recognized Institute in the field of industrial hygiene. The BG rule was used as a reference with this in mind, but with full respect for the advice of other member states in this regard. As members will appreciate, the BG rule has published a comprehensive overview of respiratory protection devices and their APFs which refers to efficiencies of 96.6% (i.e. an APF of 30) in RPE in the workplace.

Based on national recommendations published for example by HSE3 or DGUV4, wearing times of RPE are determined based on results of the workplace/task specific risk assessments and limited by company specific guidelines, as appropriate. The results of the company specific risk assessments are documented, regularly reviewed and updated in accordance with Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work and Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC. In addition, the Council Directive 89/656/EEC on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace is followed. Workers are regularly trained accordingly, as already mentioned earlier. Compliance with these rules is controlled by supervisors. The training in the safe use of PPE is carried out during the yearly conducted health and safety instructions on site and includes e.g. the handling of goggles, gloves and respiratory equipment. New employees and trainees are trained every half-year.

2 http://publikationen.dguv.de/dguv/pdf/10002/r-190.pdf 3 British Control of Substances Hazardous to Health regulation (COSHH). http://www.hse.gov.uk/pUbns/priced/hsg53.pdf 4 German BG rule “BGR/GUV-R190”. http://publikationen.dguv.de/dguv/pdf/10002/r-190.pdf CHEMICAL SAFETY REPORT 21

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

Safety goggles (3M) Respiratory protective equipment (Polimask 230) (only used for rare maintenance activities)

Safety clothing (Tyvek 800) Safety gloves (e.g. Neox 094-300)

General information on risk management related to physicochemical hazard:

Not relevant – physicochemical hazards are not the subject of this CSR.

9.0.2.4. Consumers

Exposure assessment is not applicable as there are no consumer-related uses for chromium trioxide.

CHEMICAL SAFETY REPORT 22

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

9.1. Exposure scenario 1: Use at industrial site - Functional chrome plating with decorative character for sanitary applications

Functional chrome plating is an essential process to influence the properties of a substrate in a way that the finished product performs optimal under the conditions of use. In the sanitary sector, functional chrome plating is used to achieve a surface with a high durability in contact with aggressive and demanding environmental conditions and at the same time has a high aesthetic and decorative value.

The metallic chrome layer is applied as final coating on top of a multi-layer system and the combination of underplates is responsible for the final appearance (bright or matt) of the top coating as well as for the even surface. The underplates vary depending on the different functionalities required for the final product and the used substrate.

Functional chrome plating provides substantial flexibility to treat parts with a broad range of sizes and geometries and the ability to plate inner surfaces of parts. The final surface coating does not contain any Cr(VI). Chrome plated surfaces are therefore safe to handle, and can be both machined and readily assembled.

The form of application at the facility in Iserlohn is a process chain and can be divided in three sub-processes: the pre-treatment, the main process and the post treatment. The treatments are conducted in subsequent plating baths during a wet-in-wet process, without intermediate storage of products at any time of the process chain, except for the final drying step. Numerous rinsing steps are performed along the process chain to prevent the carry-over of substances from one bath into another, which would otherwise lead to interference with the subsequent process step. At Dornbracht four plating lines are in operation regarding the functional chrome plating, three automatic, but semi-closed lines and one manual line. The required time for surface coating of the parts is short which means a time range of a few minutes. Typical products that are produced by the facility in Iserlohn are shown below.

Examples of Dornbracht products

CHEMICAL SAFETY REPORT 23

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

Operating conditions and RMMs are specified to limit workers (inhalation and dermal) exposure to various components in the treatment solution and environmental exposure. LEV and partly encapsulation of baths during treatment are technical means to minimize concentrations of Cr(VI) and other components of treatment solutions in the workplace air. Personal Protective Equipment (PPE) like goggles, chemical resistant gloves and clothing is also specified to minimize potential dermal exposure. Equipment is maintained regularly. Workers are skilled and receive regular training with regards to chemical risk management and how to properly wear PPE5. Regular housekeeping and management systems are in place ensuring high standards of operational procedures.

According to the BG rule G15, mandatory preventive and follow-up occupational medical examinations for all employees including maintenance staff and HSE responsible workers with potential exposure to hexavalent chromium have been conducted in Iserlohn. A first follow-up examination must be conducted within 6-12 months and then every 12-24 months during employment. These examinations include, among others, general medical examination, pulmonary function test and biomonitoring. According to the current occupational physician in Iserlohn, the G15 occupational medical examinations were regularly carried out since 1992. Additionally, chromium has been tested in urine since 2014; since then the recommended value of 0.6 µg/l was exceeded only once, see table below and Annex CSR 1.

Results of the urinary analysis 2014-2017 year No of examinations Average result in ug/1 2014 24 0.35 2015 52 0.08 2016 18 0.18 2017 21 0.10

In terms of the efficiency of installed critical RMM such as LEV, measuring presents unique challenges because switching off the LEV during mechanical processing of parts, which is necessary for this measurement, often results in unacceptable or, at best, undesirable release of various substances to the workplace. For this reason, as well as due to the absence of any requirement for this data for regulatory or other purpose until now, this data does not generally exist. Functionality of the LEV systems at all plating units is controlled electronically. LEV systems are well maintained, examined and tested according to German legislation. All users are trained and instructed. Employees are required to use the LEV provided and to report any defects observed. Supervisors are required to keep a record of regularly checks on their LEV systems.

Environment contributing scenario(s): Use at industrial site - Functional chrome plating with decorative character for sanitary ERC6b applications Worker contributing scenario(s): Delivery and storage of raw material PROC 1 Connecting IBC to pumping system PROC 4 Loading and unloading of jigs PROC 4 Automatic plating lines PROC 2 Manual plating process PROC 13 Sampling PROC 8b Concentration adjustment in baths with aqueous solution of CrO3 PROC 8b Regular Maintenance PROC 28 Rare Maintenance PROC 28 Waste and wastewater management PROC 8b

5 The work safety specialist conducts work safety training with all new employees upon employment and with all workers at least one time a year based on the standard operating procedures and the risk assessment. Of special emphasis is the handling of chromic acid and the correct use of PPE to ensure a safe handling of this material. The training will be documented and signed by both, the employee and the coach, and the document will then be archived. CHEMICAL SAFETY REPORT 24

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

Subsequent service life exposure scenario(s):

Not relevant.

Explanation on the approach taken for the ES

Occupational exposure estimates are based on measured data and/or on modelled data. Inhalation exposure has been estimated using the exposure model ‘Advanced REACH Tool 1.5’ or ‘ART’6. ART is a second tier model calibrated to assess exposure to inhalable dust, vapours, and mists; this Exposure Scenario is within the scope of ART. The figures obtained by modelling are considered to be worst-case estimates. Where the sample size and sampling strategy is adequate, the risk characterisation relies on the measured exposure values; in other cases, the results of the exposure modelling were used as adequate measurement data were not available.

The detailed Exposure Scenario has been developed based on information provided by the site. The site provided details of the conditions under which the activity was carried out as well as the duration and frequency of each task. This information was verified during a site visit.

The frequency of a specific activity in the worker sub-scenarios is expressed as daily activity unless otherwise stated.

Any releases to the aquatic environment are essentially negligible. Chromium trioxide is contained within the preparation and the water used to rinse out the equipment is collected and recycled or disposed of in specialist facilities. Reductive treatment of any wastewater containing Cr(VI) additionally ensures negligible release of Cr(VI) to water. This is reflected in the environmental contributing scenario below.

6 The use ART for workers exposure assessment under REACH is described in ECHA’s updated Guidance on Information Requirements and chemical safety assessment R.14, Vers. 2, May 2010. Background information for ART are provided in: Fransman W., Cherrie J., van Tongeren M., Schneider T., Tischer M., Schinkel J., Marquart H., Warren, N.D., Spankie S., Kromhout H., Tielemans E. Development of a mechanistic model for the Advanced REACH Tool (ART). Version 1.5, January 2013. CHEMICAL SAFETY REPORT 25

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

9.1.1. Environmental contributing scenario 1: Use at industrial site - Functional chrome plating with decorative character for sanitary applications

Cr(VI) releases to the environment are carefully controlled by Dornbracht and monitored by regulators.

Air emissions relating to local exhaust ventilation or extraction systems are passed through gas scrubbing filters to remove particulates prior to release to atmosphere. Dornbracht regularly monitors and reports Cr(VI) emissions as part of permit conditions. The measurements are conducted by an accredited and certified external institute. These measured data have therefore been used, in line with the applicable models and guidance, to determine the local concentration of Cr(VI) in air, and exposure to man via the environment, as set out below.

There is only very low release of Cr(VI) to the aquatic environment, if any. Water in scrubbers is recycled and occasionally replaced, with resulting material being treated as waste in accordance with relevant waste management regulations.

The wastewater is already separated in the electroplating by type and composition and distributed to the respective collection tanks. The tanks are connected via pumps with the wastewater pre-treatment plant. The tank for "alkaline concentrates" is emptied as required by a tanker via a suction line for external disposal. For the treatment of the wastewater from the other tanks there are two batch containers available. By means of the system control, the batches are filled. The process of filling is automatically interrupted when the set level in the batch is reached. During the filling process, the plant operator takes care that the level measurement is not affected by foaming in the batch. If necessary, defoamer must be added. After filling, the pre-set detoxification program starts automatically. It starts with the reduction of possibly existing hexavalent chromium. When the set parameters have been reached, the plant operator uses the existing rapid test to check whether the entire content of hexavalent chromium has been reduced. The treatment program stops when the operator confirms the success of the chromium reduction after the rapid test.

The subsequent precipitation of the metal ions then happens again automatically. After the treatment and a subsequent sedimentation phase, the treatment program stops again. The plant operator takes a sample and carries out the prescribed analyses. The analysis values can be entered under the menu item "Special". Only if all values meet the legal requirements, the treatment program can be continued. Then the withdrawal of the clear phase into a tank starts followed by pumping out the thin sludge from the tank bottom. The thin sludge is withdrawn from the lowest point of the batch and pumped into a tank. If the aforegoing sedimentation has proceeded without disruption, between 1,000 and 1,500 liters of thin sludge accumulate per treated batch. The sludge is now drained, and the resulting filter cake is removed discontinuously and filled in the lid well in front of the wastewater treatment plant.

As part of the post-treatment, the treated water free of solids is acidified in a tank and passed through an additional filter in the selective exchangers. Upon removal of residual metals in the selective exchangers, the water flows into a tank for automatic adjustment of the pH value to the discharge value between 6.5 and 9.5. From this tank, the water flows through an overflow to the final inspection.

All components of the wastewater treatment plant are built on material that complies with the German Federal Water Resources Act (WHG coated flooring). An example of the waste water treatment plant can be seen below on the pictures.

Waste materials containing Cr(VI) are classified and treated as hazardous wastes according to EU and German regulations. Furthermore, reductive treatment of any liquid waste containing Cr(VI) additionally ensures that there is, if any, negligible release of Cr(VI) to wastewater.

When the solution in the chromium tanks must be replaced completely, the solution is pumped into a separate IBC (specifically for collection) and then disposed as hazardous waste by an external waste management company (licenced contractor).

Dornbracht is permitted to release 0.1 mg Cr(VI)/l in wastewater.

CHEMICAL SAFETY REPORT 26

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

Wastewater treatment plant

9.1.1.1. Conditions of use

Amount used, frequency and duration of use (or from service life) • Daily use at site: tonnes/day • Annual use at a site: tonnes/year • Percentage of EU tonnage used at regional scale: = 100 % Conditions and measures related to sewage treatment plant • Municipal STP: Yes [Effectiveness Water: 0.148%] • Discharge rate of STP: >= 2E3 m3/d • Application of the STP sludge on agricultural soil: Yes Conditions and measures related to treatment of waste (including article waste) • Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.) Other conditions affecting environmental exposure • Receiving surface water flow rate: >= 1.8E4 m3/d

CHEMICAL SAFETY REPORT 27

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

9.1.1.2. Releases Recent point source emission data were provided and reflect potential Cr(VI) emission to air. All of the results of four consecutive measurements at each emission source in 2017 were below the detection limit. These data were used to estimate Clocalair,ann, the estimated annual average concentration in air, 100 m from point source, for the assessment of Man via Environment according to the Technical Guidance document R. 16, 2012. The fact that all measurement results were below the detection limit was not considered for the estimation as worst-case approach.

The PECregionalair,ann was estimated in EUSES2.1.2. The following assumptions have been used for estimation:

Table 10. Parameters for estimating PECregionalair Tonnage Release factor* Regional fraction** [as Cr(VI)] (%) (%) 1-10 0.035 100 %

* The release factor was estimated using tonnage and PEClocal information, provided by the site in Iserlohn ** Percentage of tonnage used at regional scale

9.1.1.2.1. Exposure estimate for man via the environment - air

The air exposure concentrations are reported in the following table.

Table 11. Cr(VI) exposure concentrations in air, 100 meter from point source

No of Sites Reporting Year Exposure estimate (mg/m3) 1 2017 3.24E-07

3 The exposure concentration of 3.24E-07 mg/m is used as worst-case estimate of Clocalair,ann. 3 The PEClocalair,ann of 3.24E-07 mg/m is estimated as sum of Clocalair,ann and PECregionalair and used as the basis for risk characterisation for man via the environment. Based on the dose-response relationship for lung cancer mortality derived by the RAC, considering a 70 year exposure time (24h/day, 7d/week), the following excess lifetime lung cancer mortality risk for the general population is derived based on the estimated exposure: 9.4E-03 per 1000 exposed. As the mechanistic evidence is suggestive of non-linearity, it is acknowledged by RAC that excess risks inferred in the low exposure range [i.e. below an exposure concentration of 1 µg Cr(VI)/m³] might be an over-estimate.

9.1.1.2.2. Exposure estimate for man via the environment – water Hexavalent chromium emission to wastewater in Iserlohn were on average around 0.01 mg/L in 2017, leading to a release fraction (in % of tonnage used) of 8.46E-03.

Table 12. Contribution to oral intake for man via the environment from local contribution

Type of food Estimated daily dose Concentration in food Drinking water 4.301E-7 mg/kg bw/day 1.505E-5 mg/L Fish 3.494E-8 mg/kg bw/day 2.127E-5 mg/kg ww Leaf crops 5.259E-5 mg/kg bw/day 0.003 mg/kg ww Root crops 2.015E-8 mg/kg bw/day 3.672E-6 mg/kg ww Meat 7.091E-10 mg/kg bw/day 1.649E-7 mg/kg ww Milk 1.322E-8 mg/kg bw/day 1.649E-6 mg/kg ww

CHEMICAL SAFETY REPORT 28

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

A) Calculation for drinking water and fish

Sum of estimated dose Drinking Water and Fish:

Drinking water 4.3E-7 mg/kg bw/day Fish 3.494E-8 mg/kg bw/day Total 4.65E-7 mg/kg bw/day

Accounting for the transformation of Cr(VI) to Cr(III) with a reduction factor of 97% (see EU RAR 2005): 4.65E-7 mg/kg bw/day x 0.03 = 1.39E-8 mg/kg bw/day = 1.39E-5 μg/kg bw/day

Based on the dose-response relationship for intestinal cancer risk derived by the RAC, considering a 70 year exposure time (24h/day, 7d/week), the following excess lifetime intestinal cancer risk for the general population is derived based on the estimated exposure: 1.12E-05 per 1000 exposed.

CHEMICAL SAFETY REPORT 29

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

9.1.2. Worker contributing scenario 1: Delivery and storage of raw material (PROC 1)

Chromium trioxide is delivered as diluted solution in sealed IBCs 600 and is then stored in a locked, designated chemical storage rack with secondary containment and with an extraction system on so called WHG coated flooring (in compliance with the German Federal Water Resources Act). The sealed IBCs are transferred from the storage to the nearby dosing station of the plant by a forklift. In order to not store more than one IBC with chromium trioxide in the storage rack in parallel, the delivery of the IBC’s is controlled respectively. …………………..chromium trioxide is delivered to the Dornbracht site in Iserlohn. There is no potential for exposure. Access to the storage cabinet is restricted to authorised, trained personnel only. A maximum of one worker is engaged in this activity. Exemplary pictures of the storage racks and the secured access system can be seen below.

Locked, designated chemical storage rack for the storage of chromium trioxide solution in IBCs.

Secured access system to the locked chemical storage rack for authorized personnel.only

CHEMICAL SAFETY REPORT 30

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

9.1.2.1. Conditions of use

Method Product (article) characteristics ▪ Substance in a mixture Qualitative Concentration of Cr(VI): < 25 % Amount used (or contained in articles), frequency and duration of use/exposure ▪ Duration of activity: < 20 min Qualitative Technical and organisational conditions and measures ▪ Containment: Closed system (minimal contact during routine operations) Qualitative ▪ Local exhaust ventilation: No Qualitative ▪ Occupational Health and Safety Management System: Advanced* Qualitative Conditions and measures related to personal protection, hygiene and health evaluation ▪ Respiratory Protection: No Qualitative Other conditions affecting workers exposure ▪ Place of use: Indoor Qualitative ▪ Process temperature: Room temperature Qualitative * Advanced Health and Safety management systems is terminology referred to within exposure assessment models such as ECETOC TRA. Such models assume that a significant reduction in exposure can be achieved through use of Health and Safety management systems and assume this to be the default for industrial operations. This can be seen to reflect the fact that companies have a duty of care to their employees through general Health and Safety at Work legislation, as well as via more specific legislation, such as the Carcinogens Directive (2004/37/EC) and the Chemical Agents at Work Directive (98/24/EC). There is no standard definition of this term but, based on regulatory requirements, it can be considered to include: • Requirement to ensure only workers essential for repairs shall be permitted to work in the affected area, and only with appropriate protection. The exposure may not be permanent and shall be minimised. • Requirement to ensure if a temporary, planned higher exposure is unavoidable (e.g. maintenance), the employer shall consult workers/representatives on the measures to minimise exposure, and provide appropriate prevention, together with access control. • Provision of appropriate hygienic circumstances for workers free of charge o Prohibition of eating/drinking/smoking in contamination risk areas o Appropriate protective clothing o Separate storage places for working/protective clothing and for street clothes o Appropriate and adequate washing and toilet facilities o Cleaned, checked and maintained protective equipment, stored in a well-defined place. • Provision of appropriate training on potential risks to health, precautions to prevent exposure, hygiene requirements, protective equipment, clothing and incidents. • Requirement to inform on objects containing carcinogens or mutagens, and label them clearly and legibly, together with warning and hazard signs. • Requirement to inform workers and/or representatives on abnormal exposures as quickly as possible.

CHEMICAL SAFETY REPORT 31

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

9.1.2.2. Exposure and risks for workers

The exposure concentrations and risk characterisation ratios (RCR) are reported in the following table.

Table 13. Exposure concentrations and risks for workers Route of exposure and type Exposure concentration Risk characterisation of effects Inhalation, local, long-term 0 µg/m3 Based on the dose-response relationship for lung cancer mortality derived by the RAC, considering a 40 year working life (8h/day, 5d/week), the following excess lifetime lung cancer mortality risk up to age 89 is derived based on the estimated exposure: 0 per 1000 exposed workers

Conclusion on risk characterisation There is no potential for exposure. The qualitatively determined exposure estimate of 0 µg Cr(VI)/m³ is used as the basis for risk characterisation. An excess lifetime lung cancer risk of 0 per 1000 exposed workers is estimated based on the above exposure estimate and the RAC dose-response relationship for lung cancer mortality.

CHEMICAL SAFETY REPORT 32

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

9.1.3. Worker contributing scenario 2: Connecting IBC to pumping system (PROC 4)

Chromium trioxide is delivered as aqueous solution in IBC containers and either stored (see WCS 1) or transported directly by a forklift to the dosing station which is part of the wastewater treatment area. First, a small plug is removed from the IBC. Then the IBC is equipped with a suction lance that is secured against unauthorized removal and a splash guard. The pictures below represent the area where the IBC’s are placed.

In a later step (see WCS 7), the aqueous solution is pumped over from the IBC containers to the dosing station for filling of 25l jerry cans. These are used for the transport of chromium trioxide to the baths for concentration adjustment.

For purpose of the exposure assessment, it is assumed that the connection of the IBC to the pumping system takes less than one minute duration. In the applicants’ facility, one laboratory worker is engaged in this activity.

IBC at dosing station

9.1.3.1. Conditions of use

Method Product (article) characteristics/substance emission potential ▪ Substance product type: Liquid ART 1.5 ▪ Concentration of Cr(VI) in mixture:< 25% ART 1.5 ▪ Process temperature: Room temperature ART 1.5 ▪ Vapour pressure of substance: < 0.01 Pa ART 1.5 ▪ Viscosity: Low ART 1.5 Activity emission potential ▪ Duration of activity: < 1 min ART 1.5 ▪ Frequency of activity: every 1-2 months (assessment factor of 0.05) ART 1.5 ▪ Primary emission source located in the breathing zone of the worker: Yes ART 1.5 ▪ Activity class: Handling of contaminated objects ART 1.5 ▪ Situation: Activities with treated/contaminated objects (surface <0.1 m²) ART 1.5

CHEMICAL SAFETY REPORT 33

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

Method ▪ Contamination level: Contamination 10-90 % of surface ART 1.5 Surface contamination ▪ Process fully enclosed? No ART 1.5 ▪ Effective housekeeping practices in place? Yes ART 1.5 Dispersion ▪ Work area: Indoors ART 1.5 ▪ Room size: 300 m3 ART 1.5 Technical and organisational conditions and measures – localised controls ▪ Primary: No localized controls (0.00 % reduction) ART 1.5 ▪ Secondary: No localized controls (0.0 % reduction) ART 1.5 ▪ Ventilation rate: Only good natural ventilation ART 1.5 Conditions and measures related to personal protection, hygiene and health evaluation ▪ Respiratory Protection: No ART 1.5

9.1.3.2. Exposure and risks for workers

Table 14. Exposure concentrations and risks for worker Route of exposure and type of Exposure concentration Risk characterisation effects Inhalation, local, long-term 6.3E-03 µg/m³ (ART 1.5 prediction, 90th percentile value) Further adjusted for frequency 3.15E-04 µg/m³ Based on the dose-response relationship for (factor 0.05) lung cancer mortality derived by the RAC, considering a 40 year working life (8h/day, 5d/week), the following excess lifetime lung cancer mortality risk up to age 89 is derived based on the estimated exposure: 1.26E-03 per 1000 exposed workers

Conclusion on risk characterisation The modelled exposure estimate7 of 3.15E-04 µg Cr(VI)/m³ is used as the basis for risk characterization. The estimate is based on several conservative assumptions regarding exposure. An excess lifetime lung cancer risk of 1.26E-03 per 1000 exposed workers is estimated based on the above exposure estimate and the RAC dose-response relationship for lung cancer mortality. As the mechanistic evidence is suggestive of non-linearity, it is acknowledged by RAC that excess risks inferred in the low exposure range [i.e. below an exposure concentration of 1 µg Cr(VI)/m³] might be an over-estimate.

7 ART print-out see Annex CSR 3 CHEMICAL SAFETY REPORT 34

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

9.1.4. Worker contributing scenario 3: Loading and unloading of jigs (PROC 4)

The loading and unloading of jigs in general is the same process at the manual and automatic plating lines. Jigs are manually loaded before the treatment and unloaded after the treatment followed by individual quality checks. Regarding the automatic plating process, the transportation of the jigs after loading and before unloading to and from the plating line is carried out automatically. In case of the manual plating process, the transportation of jigs is done manually. Exposure to Cr(VI) cannot occur directly, but through secondary sources (i.e. automatic and manual plating lines in the same work space). However, the distances to the chromium baths are about 15m (manual line) to 20m (automatic line) from the loading station and about 2m (manual line) to 6m (automatic line) from the unloading station. (see site plan below)

In the applicants’ facility, 19 workers are engaged in this activity ( ).

The pictures below show examples of the loading and unloading area of the plating lines.

Loading area at the automatic line in Iserlohn Loading area at the manual line in Iserlohn

Unloading area at the automatic line in Iserlohn Unloading area at the manual line in Iserlohn

CHEMICAL SAFETY REPORT 35

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

Site plan of automatic plating lines at Dornbracht in Iserlohn

9.1.4.1. Conditions of use

Method Product (article) characteristics ▪ Concentration of Cr(VI) in mixture: < 20 % Measured data Amount used (or contained in articles), frequency and duration of use/exposure ▪ Duration of activity: < 8 hours Measured data Technical and organisational conditions and measures ▪ Mechanical ventilation (> 2 ACH) Measured data ▪ Containment: No Measured data ▪ Local exhaust ventilation: Yes Measured data ▪ Occupational Health and Safety Management System: Advanced Measured data Conditions and measures related to personal protection, hygiene and health evaluation ▪ Respiratory Protection: No Measured data Other conditions affecting workers exposure ▪ Place of use: Indoor Measured data ▪ Room size: 35,000 m3 Measured data ▪ Process temperature (for liquid): Room temperature Measured data

9.1.4.2. Exposure and risks for workers No workplace measurement data are available for loading and unloading. However, recent measurements according to the German Ordinance on Hazardous Substances and the Technical Rule for Hazardous Substances (TRGS) 402 in form of static sampling are available since 2011 from the plating lines as worst-case assumption (see also WCS 4 and 5). All sampling results were below the respective detection limit, see Annex CSR 3. The samples were taken at the exit of the lines or directly at the top of the baths.

Altogether, the available measurement data and the enclosure of the system during the plating process show very low exposure potential for workers engaged in loading and unloading. Therefore, a worst-case assumption was carried out.

Taking 50% of the detection limit as exposure value, the mean value of these samples is 0.17 µg Cr(VI)/m³ and the 90th percentile is 0.25 µg Cr(VI)/m³. Hence, the latter one is used for risk assessment as a worst-case assumption.

CHEMICAL SAFETY REPORT 36

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

Conclusion on risk characterisation The exposure estimate based on measured data from static sampling at the plating lines (90th percentile) of 0.25 µg Cr(VI)/m³ is used as the basis for risk characterisation. An excess lifetime lung cancer risk of 1.0 per 1000 exposed workers is estimated based on the above exposure estimate and the RAC dose-response relationship for lung cancer mortality. As the mechanistic evidence is suggestive of non-linearity, it is acknowledged by RAC that excess risks inferred in the low exposure range [i.e. below an exposure concentration of 1 µg Cr(VI)/m³] might be an over-estimate.

CHEMICAL SAFETY REPORT 37

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

9.1.5. Worker contributing scenario 4: Automatic plating lines (PROC 2)

Three automatic lines are operated at the Iserlohn site, one conventional automatic plating line and two flexible working, robot-based plating lines.

All lines are partially encapsulated (side walls) with an open top (see pictures below) and installed on acid- resistant flooring which complies with the German Federal Water Resources (WHG coated flooring). Every single system is equipped with a separate exhaust system; therefore, it’s operated under negative pressure. The plating system is not in operation when doors are open.

The parts are plugged outside the lines manually onto jigs corresponding to the requirements of the parts. (see WCS 3) Then the racks are picked up by the charging system and automatically guided from bath to bath, the parts are dipped in via automatic rack systems, controlled by a program. The operators of the systems do not work on the open baths and are always outside the lines except for control and refilling operations; in this case the lines are not working, but the exhaust air ventilation is still running.

The plating process is divided in three major steps, the pre-treatment (degreasing and activation), the main chrome plating process and the post treatment (rinsing and chromium reduction). Following the plating process, the parts are unloaded manually by an operator and checked for quality.

The encapsulated plating lines are mapped in the layouts at the end of the present worker contributing scenario. There is no residual of Cr(VI) on the finished product.

A maximum of two operators per system and shift are engaged in this activity.

Encapsulated plating lines (“Gavaroline”)

Encapsulated plating line (“Varioline”)

CHEMICAL SAFETY REPORT 38

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

9.1.5.1. Conditions of use

Method Product (article) characteristics ▪ Concentration of Cr(VI) in mixture: < 20% Measured data Amount used (or contained in articles), frequency and duration of use/exposure ▪ Duration of activity: < 8 hours Measured data Technical and organisational conditions and measures ▪ Mechanical ventilation (> 2 ACH) Measured data ▪ Containment: Closed system (continuous process with occasional controlled Measured data exposure) ▪ Local exhaust ventilation: Yes Measured data ▪ Occupational Health and Safety Management System: Advanced Measured data Conditions and measures related to personal protection, hygiene and health evaluation ▪ Respiratory Protection: No Measured data Other conditions affecting workers exposure ▪ Place of use: Indoor Measured data ▪ Room size: 35,000 m3 Measured data ▪ Process temperature: 40°C Measured data

9.1.5.2. Exposure and risks for workers

Recent measurements according to the German Ordinance on Hazardous Substances and the Technical Rule for Hazardous Substances (TRGS) 402 in form of static sampling are available since 2011. All sampling results were below the respective detection limit, see Annex CSR 3. The samples were taken at the exit of the lines or directly at the top of the baths.

Altogether, the available measurement data and the enclosure of the system during the plating process show very low exposure potential for operators engaged in activities at the automatic plating lines. Taking 50% of the detection limit as exposure value, the mean value of these samples is 0.17 µg Cr(VI)/m³ and the 90th percentile is 0.25 µg Cr(VI)/m³. The latter value is used for risk assessment.

Conclusion on risk characterisation The exposure estimate based on measured data of 0.25 µg Cr(VI)/m³ is used as the basis for risk characterisation. An excess lifetime lung cancer risk of 1.0 per 1000 exposed workers is estimated based on the above exposure estimate and the RAC dose-response relationship for lung cancer mortality. As the mechanistic evidence is suggestive of non-linearity, it is acknowledged by RAC that excess risks inferred in the low exposure range [i.e. below an exposure concentration of 1 µg Cr(VI)/m³] might be an over-estimate.

CHEMICAL SAFETY REPORT 39

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

CHEMICAL SAFETY REPORT 40

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

9.1.6 Worker contributing scenario 5: Manual plating process (PROC 13)

For small series, Dornbracht operates one manual line (“Flexline”) at the Iserlohn site.

In the manual plating line, single parts or small series (1 – 6 parts) are processed. The parts to be treated are first attached to racks and dipped into the appropriate bath for degreasing. Then, the parts are rinsed and pickled. The material to be treated is immersed in nickel, chromium or copper filled bath. In principle, the metal parts to be plated are processed applying the same steps as in the automatic lines.

The work area between the individual baths is on grate floors. The pictures below give an example of this working place. The baths are exhausted above the bath surface and fed to the central exhaust ventilation unit. The volume flow of the exhaust ventilation is 12.000 m3/h.

Employees ensure proper production having one operator who is responsible for attaching and removing the parts on and from the racks, and another one for dipping them into the baths. The bath control and the necessary concentration adjustment of the baths is done manually by the plating operator. The level controls are carried out at predetermined intervals. A maximum of three workers per shift are engaged in this activity.

Manual plating line at Dornbracht site in Iserlohn

CHEMICAL SAFETY REPORT 41

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

9.1.6.1. Conditions of use

Method Product (article) characteristics ▪ Concentration of Cr(VI) in mixture: < 20% Measured data Amount used (or contained in articles), frequency and duration of use/exposure ▪ Duration of activity: < 8 hours Measured data Technical and organisational conditions and measures ▪ Mechanical ventilation (> 2 ACH) Measured data ▪ Containment: No Measured data ▪ Local exhaust ventilation: Yes Measured data ▪ Occupational Health and Safety Management System: Advanced Measured data Conditions and measures related to personal protection, hygiene and health evaluation ▪ Respiratory Protection: No Measured data Other conditions affecting workers exposure ▪ Place of use: Indoor Measured data ▪ Room size: 35,000 m3 Measured data ▪ Process temperature: 40°C Measured data

9.1.6.2. Exposure and risks for workers

Recent measurements according to the German Ordinance on Hazardous Substances and the Technical Rule for Hazardous Substances (TRGS) 402 in form of static sampling are available since 2011. All sampling results except one in 2013 were below the respective detection limit, see Annex CSR 3.

The most recent measurement from 2018 was a high-volume sampling with 45,000 l and resulted in < 0.012 Cr(VI)/m³. The mean value of all measurement results since 2011 is 0.38 µg Cr(VI)/m3 and since 2015 0.18 µg Cr(VI)/m3 (90 percentile 0.25 µg Cr(VI)/m3), taking 50% of the detection limit as exposure estimate.

Altogether, the available measurement data show low exposure potential for operators and therefore a value of 0.25 µg/m³ is used for risk assessment.

The measured values below already consider the effectiveness of LEV (reflected by the measured values).

Conclusion on risk characterisation The exposure estimate based on measured personal sampling data of 0.25 µg Cr(VI)/m³ is used as the basis for risk characterisation. This is likely a worst-case estimate because all static sampling data except one were below the LOD. An excess lifetime lung cancer risk of 1.0 per 1000 exposed workers is estimated based on the above exposure estimate and the RAC dose-response relationship for lung cancer mortality. As the mechanistic evidence is suggestive of non-linearity, it is acknowledged by RAC that excess risks inferred in the low exposure range [i.e. below an exposure concentration of 1 µg Cr(VI)/m³] might be an over-estimate.

CHEMICAL SAFETY REPORT 42

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

9.1.7. Worker contributing scenario 6: Sampling (PROC 8b)

The sampling is different for the automatic and the manual plating process.

Regarding the automatic plating line, there is a plug installed at the backside of the system, where a sample can be taken directly from the chromium bath. The respective worker wears acid-resistant gloves while filling one or more closed flasks manually.

In contrast, at the manual plating station, the worker who is equipped with acid-resistant gloves, safety goggles and an acid-resistant protection blanket, takes one or more samples using a beaker and then transfers it into a closed flask. The samples are then brought to the laboratory. During sampling, the plating line is switched off, but the local exhaust ventilation is still in operation. This activity is carried out once per week per plating line and is about five minutes duration. A maximum of three workers are engaged in this activity.

As worst case, sampling at the manual plating line was used for risk assessment.

Sampling at the manual line

9.1.7.1. Conditions of use

CHEMICAL SAFETY REPORT 43

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

Method ▪ Volume flow: < 0.1 L/min ART 1.5 ▪ Process fully enclosed: No ART 1.5 ▪ Effective housekeeping practices in place?: Yes ART 1.5 Dispersion ▪ Work area: Indoors ART 1.5 ▪ Room size: 35,000 m³ (3000 m³ used in ART) ART 1.5 Technical and organisational conditions and measures – localised controls ▪ Primary: Fixed capturing hood (90.00 % reduction) ART 1.5 ▪ Secondary: No localized controls (0.0 % reduction) ART 1.5 ▪ Ventilation rate: Mechanical ventilation (> 2 ACH) ART 1.5 Conditions and measures related to personal protection, hygiene and health evaluation ▪ Respiratory Protection: No ART 1.5

9.1.7.2. Exposure and risks for workers

Table 15. Exposure concentrations and risks for worker Route of exposure and type Exposure concentration Risk characterisation of effects Inhalation, local, long-term ART model output 0.0058 µg/m³ (90th percentile value) Further adjusted for frequency 1.16E-03 µg/m³ Based on the dose-response relationship for (frequency factor of 0.2 lung cancer mortality derived by the RAC, applied) considering a 40 year working life (8h/day, 5d/week), the following excess lifetime lung cancer mortality risk up to age 89 is derived based on the estimated exposure: 4.64E-03 per 1000 exposed workers

Conclusion on risk characterisation The modelled exposure estimate (ART)8 of 1.16E-03 µg Cr(VI)/m³ is used as the basis for risk characterisation. The estimate is based on several conservative assumptions regarding exposure. An excess lifetime lung cancer risk of 4.64E-03 per 1000 exposed workers is estimated based on the above exposure estimate and the RAC dose-response relationship for lung cancer mortality. As the mechanistic evidence is suggestive of non-linearity, it is acknowledged by RAC that excess risks inferred in the low exposure range [i.e. below an exposure concentration of 1 µg Cr(VI)/m³] might be an over-estimate.

8 ART print-out see Annex CSR 3 CHEMICAL SAFETY REPORT 44

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

9.1.8 Worker contributing scenario 7: Concentration adjustment in baths with aqueous solution of CrO3 (PROC 8b)

The concentration adjustment is carried out at both types of plating lines (automatic and manual) in the same way but is divided in two parts: the filling on the one hand and the adjustment at the baths on the other hand. (see pictures below) Therefore, two sub-scenarios are performed for the risk assessment.

When the concentration of chromium trioxide in the baths has to be adjusted, the chromium containing solution is dosed into a 25l jerry can. This is done at the dosing station (open, ventilated booth) in the wastewater treatment plant and then the jerrycan is brought to the respective plating line.

At the plating lines, the jerry can is connected to a pumping station which is, in case of the automatic lines, at the back side or, in case of the manual plating line, at the front side of the system. The re-filling of the chromium baths is then carried out automatically. It is assumed as a worst case that concentration adjustment takes place once per week.

A maximum of two workers per shift s are engaged in this activity.

Jerry can connected to chromium bath (automatic Filling of jerry can at the dosing station lines)

CHEMICAL SAFETY REPORT 45

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

9.1.8.1. Conditions of use

9.1.8.1.1. Filling of jerrycan Method Product (article) characteristics/substance emission potential ▪ Substance product type: Liquid ART 1.5 ▪ Concentration of Cr(VI) in mixture: 25 % ART 1.5 ▪ Process temperature: Room temperature ART 1.5 ▪ Vapour pressure of substance: < 0.01 Pa ART 1.5 ▪ Viscosity: Low ART 1.5 Activity emission potential ▪ Duration of activity: < 5 min ART 1.5 ▪ Frequency of exposure: 1 time /week (factor of 0.2 applied) ART 1.5 (extended) ▪ Primary emission source located in the breathing zone of the worker: Yes ART 1.5 ▪ Activity class: Falling liquids ART 1.5 ▪ Situation: Transfer of liquid product with flow of 1 - 10 l/minute ART 1.5 ▪ Containment level: Handling that reduces contact between product and adjacent air ART 1.5 ▪ Loading type: Splash loading, where the liquid dispenser remains at the top of the ART 1.5 reservoir and the liquid splashes freely Surface contamination ▪ Process fully enclosed? No ART 1.5 ▪ Effective housekeeping practices in place? Yes ART 1.5 Dispersion ▪ Work area: Indoors ART 1.5 ▪ Room size: 300 m3 ART 1.5 Technical and organisational conditions and measures – localised controls ▪ Primary: No localized controls (0.0 % reduction) ART 1.5 ▪ Secondary: No localized controls (0.0 % reduction) ART 1.5 ▪ Ventilation rate: 3 air changes per hour (ACH) ART 1.5 Conditions and measures related to personal protection, hygiene and health evaluation ▪ Respiratory Protection: No ART 1.5

9.1.8.1.2. Adjustment of bath Method Product (article) characteristics/substance emission potential ▪ Substance product type: Liquid ART 1.5 ▪ Concentration of Cr(VI) in mixture: 25 % ART 1.5 ▪ Process temperature: Room temperature ART 1.5 ▪ Vapour pressure of substance: < 0.01 Pa ART 1.5 ▪ Viscosity: Low ART 1.5 Activity emission potential ▪ Duration of activity: < 5 min ART 1.5 ▪ Frequency of exposure: 1 time /week (factor of 0.2 applied) ART 1.5 (extended) ▪ Primary emission source located in the breathing zone of the worker: Yes ART 1.5

CHEMICAL SAFETY REPORT 46

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

Method ▪ Activity class: Falling liquids ART 1.5 ▪ Situation: Transfer of liquid product with flow of 1 - 10 l/minute ART 1.5 ▪ Containment level: Open process ART 1.5 ▪ Loading type: Splash loading, where the liquid dispenser remains at the top of the ART 1.5 reservoir and the liquid splashes freely Surface contamination ▪ Process fully enclosed? No ART 1.5 ▪ Effective housekeeping practices in place? Yes ART 1.5 Dispersion ▪ Work area: Indoors ART 1.5 ▪ Room size: 35,000 m3 (3000 m³ used in ART) ART 1.5 Technical and organisational conditions and measures – localised controls ▪ Primary: Fixed capturing hood (90.00 % reduction) ART 1.5 ▪ Secondary: No localized controls (0.0 % reduction) ART 1.5 ▪ Ventilation rate: Mechanical ventilation (> 2 ACH) ART 1.5 Conditions and measures related to personal protection, hygiene and health evaluation ▪ Respiratory Protection: No ART 1.5

9.1.8.2. Exposure and risks for workers

Table 16. Exposure concentrations and risks for worker Route of exposure and type Exposure concentration Risk characterisation of effects Inhalation, local, long-term ART model output 0.3 µg/m³ (90th percentile value) Further adjusted for frequency 0.06 µg/m³ Based on the dose-response relationship for (factor 0.2) lung cancer mortality derived by the RAC, considering a 40 year working life (8h/day, 5d/week), the following excess lifetime lung cancer mortality risk up to age 89 is derived based on the estimated exposure: 0.24 per 1000 exposed workers

Conclusion on risk characterisation The modelled exposure estimate (ART 1.5)9 of 0.06 µg Cr(VI)/m³ is used as the basis for risk characterisation (worst case). The estimate is based on several conservative assumptions regarding exposure. An excess lifetime lung cancer risk of 0.24 per 1000 exposed workers is estimated based on the above exposure estimate and the RAC dose-response relationship for lung cancer mortality.

9 ART print-out see Annex CSR 3 CHEMICAL SAFETY REPORT 47

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

9.1.9. Worker contributing scenario 8: Regular Maintenance (PROC 28)

Regular maintenance of the automatic and the manual plating lines is strictly controlled and documented with the help of maintenance plans. Regular maintenance is performed by plant operators from the plating department. Adequate PPE is worn e.g. protective clothing, chemical-resistant gloves and goggles during this activity. Regarding the automatic plating lines (Gavaroline and Varioline), there is an additional maintenance of the air scrubber which is carried out every 2-3 months for the rinsing module and every third month for the plating modules (chromium- and nickel-based). Maintenance rates are chosen depending on the manufacturer information. The maintenance of the modules themselves comprises a visual check of the baths, pipes, pumps, filter systems, exhaust pipes and drip pans which is done every month. Here, the components are checked regarding tightness and impurities. During the afore mentioned maintenance steps, the plating lines are switched off, but the local exhaust ventilation is still in operation. The exhaust ventilation system is maintained approximately every second year. For the manual plating process (Flexline) the maintenance of the air scrubber, the plating modules and the exhaust ventilation system is carried out in the same periods than for the automatic plating lines. For purpose of this exposure assessment, it is assumed that regular maintenance work is performed by up to three plant operators, while other maintenance work is performed by maintenance staff (see WCS 9: Rare Maintenance). A maximum duration of 2 hours is anticipated for the monthly maintenance activities.

9.1.9.1. Conditions of use

Method Product (article) characteristics/substance emission potential ▪ Substance product type: Liquid ART 1.5 ▪ Concentration of Cr(VI) in mixture: < 20% ART 1.5 ▪ Process temperature: Above room temperature ART 1.5 ▪ Vapour pressure of substance: < 0.01 Pa ART 1.5 ▪ Viscosity: Low ART 1.5 Activity emission potential ▪ Duration of activity: < 2 hours ART 1.5 ▪ Frequency of activity: 1 time/month (factor o0f 0.05 applied) ART 1.5 (extended) ▪ Primary emission source located in the breathing zone of the worker: Yes ART 1.5 ▪ Activity class: Activities with relatively undisturbed surfaces (no aerosol formation) ART 1.5 ▪ Situation: Open surface 1 - 3 m² ART 1.5 Surface contamination ▪ Process fully enclosed? No ART 1.5 ▪ Effective housekeeping practices in place? Yes ART 1.5 Dispersion ▪ Work area: Indoors ART 1.5 ▪ Room size: 35,000 m3 (3000 m³ used in ART) ART 1.5 Technical and organisational conditions and measures – localised controls ▪ Primary: Fixed capturing hood (90.00 % reduction) ART 1.5 ▪ Secondary: No localized controls (0.0 % reduction) ART 1.5 ▪ Ventilation rate: Mechanical ventilation (> 2 ACH) ART 1.5 Conditions and measures related to personal protection, hygiene and health evaluation ▪ Respiratory Protection: No ART 1.5

CHEMICAL SAFETY REPORT 48

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

9.1.9.2. Exposure and risks for workers

Table 17. Exposure concentrations and risks for worker Route of exposure and type Exposure concentration Risk characterisation of effects Inhalation, local, long-term ART model output 0.14 µg/m³ (90th percentile value) further adjusted for 0.007 µg/m³ Based on the dose-response relationship for frequency lung cancer mortality derived by the RAC, (frequency factor considering a 40 year working life (8h/day, 0.05) 5d/week), the following excess lifetime lung cancer mortality risk up to age 89 is derived based on the estimated exposure: 0.028 per 1000 exposed workers

Conclusion on risk characterisation The modelled exposure estimate (ART 1.5)10 of 0.007 µg Cr(VI)/m³ is used as the basis for risk characterisation (worst case). The estimate is based on several conservative assumptions regarding exposure. An excess lifetime lung cancer risk of 0.028 per 1000 exposed workers is estimated based on the above exposure estimate and the RAC dose-response relationship for lung cancer mortality.

10 ART print-out see Annex CSR 3 CHEMICAL SAFETY REPORT 49

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

9.1.10. Worker contributing scenario 9: Rare Maintenance (PROC 28)

Similar to the regular maintenance, rare maintenance of the automatic and manual plating lines which is done by maintenance staff is strictly controlled and documented with the help of maintenance plans. If required, external experts will be consulted. Adequate PPE like protective clothing, chemical-resistant gloves, goggles, RPE in case LEV is switched off is worn.

One time per year the rinsing baths are emptied and cleaned, which needs around 2 hours per line. The chrome baths are emptied and cleaned in the same way. The content of the chrome bath is pumped into intermediate containers, which are situated next to the plating line. Sludge on the bottom of the bath is removed and disposed into special containers. Afterwards, the Cr(VI) sludge is disposed by an external, specialised company. The plating lines are switched off, but the local exhaust ventilation is still in operation. Following the cleaning process, the bath is refilled with the chromium solution. The composition of the bath is analysed and adjusted, if necessary (see WCS 6 and 7). Operators wear full protective equipment during this task.

A maximum of three operators are engaged in the cleaning of the rinsing baths11.

9.1.10.1. Conditions of use

Method Product (article) characteristics/substance emission potential ▪ Substance product type: Liquid ART 1.5 ▪ Concentration of Cr(VI) in mixture: < 20% ART 1.5 ▪ Process temperature: Room temperature ART 1.5 ▪ Vapour pressure of substance: < 0.01 Pa ART 1.5 ▪ Viscosity: Low ART 1.5 Activity emission potential ▪ Duration of activity: < 8 h (2h per line) ART 1.5 ▪ Frequency of activity: 1 time/year (adjustment factor of 0.005 applied) ART 1.5 (extended) ▪ Primary emission source located in the breathing zone of the worker: Yes ART 1.5 ▪ Activity class: Handling of contaminated objects ART 1.5 ▪ Activities with treated/contaminated objects (surface 1- 3 m²) ART 1.5 ▪ Level of contamination: Contamination 10-90% of surface ART 1.5 Surface contamination ▪ Process fully enclosed? No ART 1.5 ▪ Effective housekeeping practices in place? Yes ART 1.5 Dispersion ▪ Work area: Indoors ART 1.5 ▪ Room size: 35,000 m3 (3000 m³ used in ART) ART 1.5 Technical and organisational conditions and measures – localised controls ▪ Primary: Fixed capturing hood (90.00 % reduction) ART 1.5 ▪ Secondary: No localized controls (0.0 % reduction) ART 1.5 ▪ Ventilation rate: Mechanical ventilation (> 2 ACH) ART 1.5

11 This worst-case scenario would imply that all four plating lines would need rare maintenance at the same time and that this maintenance would be conducted simultaneously during the same shift by three workers. CHEMICAL SAFETY REPORT 50

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

Method Conditions and measures related to personal protection, hygiene and health evaluation ▪ Respiratory Protection: Yes ART 1.5 (extended) During maintenance, half-face mask with P3 filter is used (APF 30 according to the German BG rule BGR/GUV-R190)

9.1.10.2. Exposure and risks for workers

Table 18. Exposure concentrations and risks for worker Route of exposure and type Exposure concentration Risk characterisation of effects Inhalation, local, long-term ART model output 0.17 µg/m³ (90th percentile value) further adjusted for 8.5E-04 µg/m³ frequency (frequency factor 0.005) Further adjusted for 2.81E-05 µg/m³ Based on the dose-response relationship for RPE (factor 0.033) lung cancer mortality derived by the RAC, considering a 40 year working life (8h/day, 5d/week), the following excess lifetime lung cancer mortality risk up to age 89 is derived based on the estimated exposure: 1.12E-04 per 1000 exposed workers

Conclusion on risk characterisation The modelled exposure estimate (ART 1.5)12 of 2.81E-05 µg Cr(VI)/m³ is used as the basis for risk characterisation (worst case). The estimate is based on several conservative assumptions regarding exposure. An excess lifetime lung cancer risk of 1.12E-04 per 1000 exposed workers is estimated based on the above exposure estimate and the RAC dose-response relationship for lung cancer mortality.

12 ART print-out see Annex CSR 3 CHEMICAL SAFETY REPORT 51

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

9.1.11. Worker contributing scenario 10: Waste and wastewater management (PROC 8b)

Subsequently to the plating process, process waste as well as wastewater arises.

The process waste (e.g. sludge which is waste resulting from cleaning activities) is stored in closed containers. These containers are further collected by licensed waste management companies for treatment, incineration and disposal of incineration residues at licensed landfills.

Regarding the wastewater, very low amounts of Cr(VI), if at all, are released from wastewater treatment systems, where residual Cr(VI) is reduced to Cr(III). Resulting Cr(III) is then precipitated and disposed to licensed waste management companies.

This is a fully automatic and enclosed process. Additionally, the sampling step before discharging the waste water to the public sewage system (carried out through a manhole) is a short-term activity and the concentration of Cr(VI) is very low (see 9.1.1.). Hence, there is no potential of inhalation exposure from the wastewater treatment systems. This is demonstrated by the modelled scenario below. One worker is engaged in this activity.

9.1.11.1. Conditions of use

Method Product (article) characteristics/substance emission potential ▪ Substance product type: Liquid ART 1.5 ▪ Concentration of Cr(VI) in mixture: minute ART 1.5 ▪ Process temperature: Room temperature ART 1.5 ▪ Vapour pressure of substance: < 0.01 Pa ART 1.5 ▪ Viscosity: Low ART 1.5 Activity emission potential ▪ Duration of activity: < 10 min ART 1.5 ▪ Primary emission source located in the breathing zone of the worker: Yes ART 1.5 ▪ Activity class: Falling liquids ART 1.5 ▪ Situation: Transfer of liquid product with flow of 0.1 - 1 l/min ART 1.5 ▪ Loading type: Splash loading, where the liquid dispenser remains at the top of the ART 1.5 reservoir and the liquid splashes freely Surface contamination ▪ Process fully enclosed? No ART 1.5 ▪ Effective housekeeping practices in place? Yes ART 1.5 Dispersion ▪ Work area: Indoors ART 1.5 ▪ Room size: Any size workroom ART 1.5 Technical and organisational conditions and measures – localised controls ▪ Primary: No localized controls (0.0 % reduction) ART 1.5 ▪ Secondary: No localized controls (0.0 % reduction) ART 1.5 ▪ Ventilation rate: Only good natural ventilation ART 1.5 Conditions and measures related to personal protection, hygiene and health evaluation ▪ Respiratory Protection: No ART 1.5

CHEMICAL SAFETY REPORT 52

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

9.1.11.2. Exposure and risks for workers

Table 19. Exposure concentrations and risks for worker Route of exposure and type Exposure concentration Risk characterisation of effects Inhalation, local, long-term ART model output 0.0023 µg/m³ Based on the dose-response relationship for (90th percentile value) lung cancer mortality derived by the RAC, considering a 40 year working life (8h/day, 5d/week), the following excess lifetime lung cancer mortality risk up to age 89 is derived based on the estimated exposure: 0.009 per 1000 exposed workers

Conclusion on risk characterisation The modelled exposure estimate (ART 1.5)13 of 0.0023 µg Cr(VI)/m³ is used as the basis for risk characterisation (worst case). The estimate is based on several conservative assumptions regarding exposure. An excess lifetime lung cancer risk of 0.009 per 1000 exposed workers is estimated based on the above exposure estimate and the RAC dose-response relationship for lung cancer mortality.

13 ART print-out see Annex CSR 3 CHEMICAL SAFETY REPORT 53

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

10. RISK CHARACTERISATION RELATED TO COMBINED EXPOSURE 10.1. Human health 10.1.1. Workers

Workers in the functional chrome plating process at the sites may have some combinations of tasks (site- specific).

The highest combined exposure estimate would arise from the combination of WCSs 4 (or alternatively, WCS 5), 6, 7, 8 and 9 which results in a combined exposure estimate of 0.32 μg Cr(VI)/m³.

Worker Exposure Contributing Concentration Scenario (µg CrVI/m³) (WCS 4 0.25)

WCS 5 0.25

WCS 6 1.16E-03

WCS 7 0.06

WCS 8 0.007

WCS9 2.81E-05

∑ 0.32 (Combined exposure estimate)

In this case, an excess lifetime lung cancer risk of 1.27 per 1000 exposed workers is estimated based on the above exposure estimate and the RAC dose-response relationship for lung cancer mortality.

10.1.2. Consumer

Not relevant as there is no consumer use.

10.2. Environment (combined for all emission sources) 10.2.1. All uses (regional scale)

10.2.1.1. Regional exposure

Environment

The regional predicted environmental concentration (PEC regional) and the related RCRs when a PNEC is available are presented in the table below.

The PEC regional have been estimated with EUSES.

CHEMICAL SAFETY REPORT 54

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EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0

Table 20. Predicted regional exposure concentrations (Regional PEC)

Protection target Regional PEC RCR Freshwater Not relevant Not relevant Sediment (freshwater) Not relevant Not relevant Marine water Not relevant Not relevant Sediment (marine water) Not relevant Not relevant Air 2.58E-16 mg/m³ Not relevant Agricultural soil Not relevant Not relevant

Man via environment

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.

Table 21. Regional exposure to man via the environment

Route Regional exposure Risk characterisation Inhalation 2.58E-16 mg/m³ Based on the dose-response relationship for lung cancer mortality derived by the RAC, considering a 70 year exposure time (24h/day, 7d/week), the following excess lifetime lung cancer mortality risk for the general population is derived based on the estimated exposure: 7.48E-12 per 1000 exposed. Oral Negligible

10.2.2. Local exposure due to all wide dispersive uses

Not relevant as there are not several wide dispersive uses covered in this CSR.

10.2.3. Local exposure due to combined uses at a site

Not relevant as there are no combined uses at a site.

CHEMICAL SAFETY REPORT 55

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