chemical safety report (based on sections 9 and 10)

Chemical Safety Report____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Formulation CSR Hapoc GmbH & Co. KG 1

Chemical Safety ReportChemical Safety Report

(based on Sections 9 and 10)

Applicant: HAPOC GmbH & Co KG

Applied for by: HAPOC GmbH & Co KG

Substance(s): Chromium trioxide and its aqueous solutions

Name of use: Use of chromium trioxide in dissolved and solid form

to produce aqueous solutions of any composition for

industrial application.

Use number: 1



BASIS OF THE PERFORMED ANALYSIS FOR AUTHORISATION IN CSR, AOA AND SEA.............................................. 3

CONTEXT OF THE FULL APPLICATION FOR AUTHORISATION.................................................................................. 4

SUMMARY OF THE CSR ......................................................................................................................................... 7

1 SPECIFICATION OF THE USE FOR WHICH AUTHORISATION IS BEING REQUESTED ............................................... 9

1.1 EXPLANATIONS ON THE USE AND THE USERS .................................................................................................................. 9

1.1.1 Visual illustration of the requested use, using the example of a formulation based on liquid concentrate

............................................................................................................................................................................ 10

2 ESTIMATION OF EXPOSURES (AND THE ASSOCIATED CHARACTERISATION OF THE RISK SITUATION) ................13

2.1 OVERVIEW OF USES AND EXPOSURE SCENARIOS............................................................................................................ 13

2.1.1 Contributing scenario (1) controlling environmental exposure: environmental exposure when

formulating preparations (mixtures). ................................................................................................................. 14

2.1.2 Contributing scenario (2) controlling worker exposure for moving substances or mixtures from storage

containers to formulation plants........................................................................................................................ 16

2.1.3 Contributing scenario (3) controlling worker exposure when mixing chromium trioxide in liquid

formulations ....................................................................................................................................................... 19

2.1.4 Contributing scenario (5) controlling worker exposure when maintaining formulation plants ................ 21

2.1.5 Real exposure levels as a result of using risk minimisation measures....................................................... 23

2.1.6 Guidelines for downstream users to assess whether they are within the limits defined in the ES ............ 23

2.2 DISCHARGE INTO THE ENVIRONMENT ......................................................................................................................... 24

2.2.1 Limitation of the scope of assessment ...................................................................................................... 24

2.2.2 Discharge via exhaust air after cleaning by in-house exhaust air treatment plants ................................. 25

2.3 IMPACT ON HUMANS VIA THE ENVIRONMENT............................................................................................................... 29

3 EXPLANATIONS ON RISK ASSESSMENT RELATING TO THE TOXICOLOGICAL RISK AT THE WORKPLACE ..............30

3.1 GENERAL RISK ASSESSMENT OF CHROMIUM TRIOXIDE IN SURFACE FINISHING...................................................................... 30

3.2 OFFICIALLY RECOGNISED OCCUPATIONAL DISEASE INCIDENCE IN GERMANY RELATING TO CHROMIUM AND ITS COMPOUNDS AS THE

CAUSE ....................................................................................................................................................................... 30

3.3 INCIDENCE OF NEW CASES OF ILLNESS ACCORDING TO HUNT ........................................................................................... 33

3.4 CATEGORISATION OF COMPANIES BASED ON THE DOSE-RESPONSE RELATIONSHIP ................................................................ 36

3.4.1 Preliminary remarks on assessing risk according to a dose-response relationship ................................... 36

3.4.1.1 Critical assessment of the basis of the dose-response relationship..........................................................36

3.4.2 Application of the dose-response relationship .......................................................................................... 38

3.5 QUANTITATIVE RESULTS FROM APPLYING THE DOSE-RESPONSE RELATIONSHIP (DSR)........................................................... 39

4 ESTIMATION OF THE RISK BASED ON PHYSICO-CHEMICAL PROPERTIES ............................................................40

4.1 GENERAL INFORMATION ON RISK MANAGEMENT RELATING TO TOXICOLOGICAL HAZARDS ..................................................... 40

4.2 GENERAL INFORMATION ON RISK MANAGEMENT RELATING TO PHYSICO-CHEMICAL HAZARDS ................................................ 41

4.3 RISK TO CONSUMERS .............................................................................................................................................. 41

4.4 NOTES ON EXPOSURE DATA:..................................................................................................................................... 41

4.5 CONCLUSIONS ON RISK CHARACTERISATION: ................................................................................................................ 42

5 REFERENCES ......................................................................................................................................................43

6 FORMULATION OF THE FULL APPLICATION FOR AUTHORISATION ....................................................................45



Basis of the performed analysis for authorisation in CSR, AoA and SEA

1. The analysis performed for the application for authorisation relates to the typical use of a

surface-finishing service provider, which may result in various applications. The analysis

does not consider specific products, articles or their applications. In fact, priority is

given to the variable use of the substance by a surface-finishing service provider. This is

necessary because it is the use of chromium trioxide that should be authorised, and not the

final use of the surface-modified component or article (which, in the scope of this

application, does not contain the substance requiring authorisation). The latter are not

influenced or able to be selected or modified by the surface-finishing service provider, rather

they are always specified by the client.

2. This report essentially considers an individual company and its possibilities of identifying

and minimising its specific, operational risk. Otherwise the level of risk would depend

statistically on the current number of companies active across Europe and would therefore

vary with time. The regulation of this kind of overall risk cannot be achieved with individual

authorisations.

3. The present application uses predominantly official data, official measurements and

assessment criteria (e.g. dose-response relationship) and their recommendations and

guidelines. Using these specifications, the real observable risk as a result of using the

SVHC in the individual company is determined. This is the basis for evaluating the indirect

costs from the use scenario.

4. For the socio-economic assessment, both operating parameters and parameters in the

supply chains are used.

5. The applicant commits itself and the companies it supplies, to regularly document

compliance with the boundary conditions defined in this application, even during the review

period. This relates firstly, of course, to the risk level that needs to be adhered to and the

socio-economic minimum requirements. It is also obligatory to continuously document the

active development of measures to further minimise the risk as well as substitution options.

If the applicant receives the necessary authorisations, these obligations will become part of

the General Terms of Delivery.



Context of the full application for authorisation

for the

Use of chromium trioxide in dissolved and solid form to produce aqueous

solutions of any composition for industrial application with a maximum risk level

of 4:10 000

The risk assessment of the Chemical Safety Report (CSR) is broken down into two parts:

1. Presentation of the standard technical equipment for performing the use, which is a

traditional basic process engineering operation. It also contains a description of the

contributing exposure scenarios and the risk minimisation measures. In addition, it

contains statements on the company organisation and its impact on the risk situation.

2. The real operational risk is quantified in three ways in order to evaluate the plausibility of

the results by means of a comparison:

a. assessment of the real risk impact using official case numbers (using Germany

as an example);

b. evaluation using a WHO meta-study

c. evaluation using the ECHA-defined dose-response relationship for chromium

trioxide.

The following key results were found:

- Examples of real measurements in companies in recent years support the low exposure

concentrations, measurements fall significantly below (about a factor of 3 to 6) the

requested maximum level of 4:10 000 (equivalent to 0.1 µg/m³ chromium trioxide).

- Similar technical equipment may result in considerably different exposure doses,

depending on the production range, which makes it necessary to cap the maximum risk

for the application for authorisation.

- All three of the above-specified approaches to describe the risk yield comparable

quantitative levels of risk depending on the respective dose.

- The term ‘statistical first case limit’ was introduced to quantitatively compare different

risk scenarios; it describes the maximum number of exposed workers that have not

developed a statistically expected first case of illness in the company, in 50 years of

operation.

- The statistical first case limit in the present case of a maximum risk of 4:10 000 is at

least 2 000; i.e. only at a number of more than 2 000 exposed workers would a first case

of illness be statistically expected within 50 years of operation.



- As downstream users of the assessed use are generally SMEs or smaller, specialised

divisions of larger companies, this statistical first case limit is often far above the reality;

there are usually 1–20 exposed workers. As a logical consequence, it must be assumed

under the given conditions that no case of illness would be expected in more than 5 000

operating years.

- As a logical consequence, further risk minimisation measures beyond the defined risk

maximum or the reduction in the use as a result of non-issued authorisations under the

given conditions of this application, may not lead to a measurable result or a detectable

improvement in the risk situation and are therefore not useful.

Analysing the alternatives leads to the conclusion that the requested use cannot be replaced

independently because it is a requirement for specific technologies:

1. the analysis of the alternatives relates to a process that provides the starting chemicals for

the use of aqueous solutions of chromium trioxide (formulation);

2. the formulator itself has no option of reducing the risk by changing the substance because it

is precisely this substance that is needed and requested by their customers;

3. the formulator may become aware of new developments in their customers’ business as a

result of a reduction in requirement and therefore decrease in sales.

The core findings of the Socio-Economic Analysis (SEA) are expressed in the following:

- The requested use is a service for downstream users, which directly further utilises the

product of the use – an aqueous solution of chromium trioxide; the use does not have

any other intended purpose.

- It is not useful to specify an alternative because the subsequent uses require the

prepared solutions. It is not possible to conceive another way of producing the

substance than as a solution. It is also clear that it is pointless to look at alternative

substances.

- The estimations of the socio-economic disadvantages for the community are based on

the most favourable, i.e. lowest still plausible monetary losses for the community; these

estimations take into account the subsequent uses with which there is an existential

interrelationship. The requested use depends, in terms of socio-economics, directly on

the subsequent use situation.

- The socio-economic disadvantages for the community associated with the scenario of

non-use consist of three components:

o loss of profit to date = loss of taxable income for the community (time limited);



o loss of turnover to date = necessary subsistence of the affected former

employees by the community (time limited);

o loss of “added value” to the value-added chains in their form to date = decreased

added value of the finished products (permanent);

- The welfare costs of the usage scenario were calculated based on the ECHA-defined

dose-response relationship (see CSR); the assumed average costs of an illness

represent the worst case scenario as the absolute amount could not be made plausible

and therefore had to be set lower.

- The maximum risk level of 4:10 000 assumed in this application gives a ratio of at least

1:1 400 of welfare costs to socio-economic benefit. The annual welfare costs per worker

do not even exceed the value of EUR 15 even in the most unfavourable conditions.

Levels fall well below those specified as soon as the theoretical worst case scenario is

modified to the usual real situation; real measurements show far lower exposures and

therefore lower welfare costs.

- Even with minimal socio-economic advantages and maximum welfare costs of the use

scenario and assuming a maximum risk level, the socio-economic advantages of the use

scenario significantly exceed the disadvantages.



Summary of the CSR

The present dossier requests authorisation for the use



of 4:10 000

The risk assessment of the Chemical Safety Report (CSR) is broken down into two parts:

1. Presentation of the standard technical equipment to carry out the use, which is a

traditional basic process engineering operation. It also contains a description of the

contributing exposure scenarios and the risk minimisation measures. In addition, it

contains statements on the company organisation and its impact on the risk situation.

2. The real operational risk is quantified in three ways in order to evaluate the plausibility of

the results by means of a comparison:

a. assessment of the real risk impact using official case numbers (using Germany

as an example);

b. evaluation using a WHO meta-study;

c. evaluation using the ECHA-defined dose-response relationship for chromium

trioxide.

The following key results were found:

- Examples of real measurements in companies in recent years support the low exposure

concentrations, measurements fall significantly below (about a factor of 3 to 6) the

requested maximum level of 4:10 000 (equivalent to 0.1 µg/m³ chromium trioxide).

- Similar technical equipment may result in considerably different exposure doses,

depending on the production range, which makes it necessary to cap the maximum risk

for the application for authorisation.

- All three of the above-specified approaches to describe the risk yield comparable

quantitative levels of risk depending on the respective dose.

- The term ‘statistical first case limit’ was introduced to quantitatively compare different

risk scenarios; it describes the maximum number of exposed workers that have not

developed a statistically expected first case of illness in the company, in 50 years of

operation;

- The statistical first case limit in the present case of a maximum risk of 4:10 000 is at

least 2 000; i.e. only at a number of more than 2 000 exposed workers would a first case

of illness be statistically expected within 50 years of operation.

- As downstream users of the assessed use are generally SMEs or smaller, specialised

divisions of larger companies, this statistical first case limit is often far above the reality;



there are usually 1–20 exposed workers. As a logical consequence, it must be assumed

under the given conditions that no case of illness would be expected in more than 5 000

operating years.

- As a logical consequence, further risk minimisation measures beyond the defined risk

maximum or the reduction in the use as a result of non-issued authorisations under the

given conditions of this application, may not lead to a measurable result or a detectable

improvement in the risk situation and are therefore not useful.



1 Specification of the use for which authorisation is being requested

Authorisation is requested for the following use:



of 4:10 000

Preliminary note: the nomenclature is evidently not entirely consistent in the REACH legislation

and its regulations and guidelines. While the REACH Regulation refers to uses (Verwendungen)

that are to be authorised, the applicant is a user (Anwender). Similarly, the process categories

(PROC) refer to uses, although several of these could apply to the requested use. For this

reason, we are clarifying which definitions form the basis of the present application:

Use = general use of the chemicals being assessed in the authorisation application. This

corresponds to the terminology in the REACH Regulation and the Fee Regulation.

Application = specific technical application with regard to the effect intended in the finished

product. This differentiation is required because the substances in question generally no longer

exist in the finished product and therefore do not need to be considered.

Apparatus type = type and character of the technical equipment in which the technical

application of the basic use will be performed.

1.1 Explanations on the use and the users

Aqueous chromium trioxide solutions are used in many applications for the surface treatment of

structural components. However, the available raw material is a solid, generally flaky chromium

trioxide material.

Production companies need the solutions and the solid in the most diverse quantities, various

concentrations and with different additives, in some cases in very small additions. For this

reason, many companies use on-site formulation, i.e. mixing substances which is not possible

at the required level of precision if only small quantities are required.

Central production sites of supplier companies (‘formulators’) are cost-effective for various

reasons:

- by manufacturing larger batches, small additions can also be made with greater

accuracy;

- trained personnel produce the mixtures under defined routines;

- smaller useful quantities are filled under the same safety conditions;

- permanently set up mixing stations and safety devices ensure exposure is prevented;

- fewer, central formulation facilities ensure a minimum number of workers coming into

contact with chromium trioxide.



The substance is transported in secure, sealed containers, which enable extraction using

automated systems or pumping equipment.

1.1.1 Visual illustration of the requested use, using the example of a formulation based

on liquid concentrate

1 Provision of chromium (VI) solution as available on the market.

(uses solid chromium trioxide as a starting material, so is initially produced as a concentrate.)

2 Removing the original label as a result of modifying/formulating the present starting product.

3 Correct labelling of the finished product on the existing hazardous goods packaging.

4 The required starting quantity of the chromium trioxide solution is ordered directly from the manufacturer in the correct concentration and quantity.

Subsequent formulation takes place directly in the existing hazardous goods packaging (IBC).



5 Addition in accordance with the present formula of a defined quantity of a ready-made special additive using a rod pump.

6 Manual emptying of the residue of the special additive storage container into the IBC.

7 Pouring in a precisely defined quantity of deionised water in accordance with the formula using a calibrated production balance.

8 Mixing the poured water in the IBC using a rod pump.

9 Homogeneous mixing of the formulated solution using the previously used rod pump for a precisely defined period of time.



10 Taking out the produced solution using the existing rod pump to fill a measuring beaker.

11 Filling a plastic bottle as a retain sample for quality control purposes in the in-house quality lab and for traceability.

12 Removing the production aids. Sealing the IBC properly. Storage in a quarantine store until laboratory release of the retain sample following quality control.

13 Collecting the contaminated production aids and taking them to a dedicated cleaning area.

14 Correctly cleaning the production aids using water. The duration of the described batch production including cleaning the production aids takes about an hour on average.



Chromium trioxide is mixed with water directly upon the request of users of the solution, which

they need to treat the surface of other structural components. It is not a finished product but an

intermediate product within supply chains. There is no application of the solutions for the end

customers, i.e. the consumer sector.

For the further illustration of this application it is important to consider that the formulation of

aqueous solutions in accordance with the requested use directly depends on the demand of

downstream users that use these formulations/mixtures for production. Without this demand

there would be no need for formulation/mixing and it would not be performed.

2 Estimation of exposures (and the associated characterisation of the risk situation)

2.1 Overview of uses and exposure scenarios

Title of the requested use:



of 4:10 000.

The requested use can be performed in the most diverse containers and apparatus, in particular

in the most varying scales. The common factor in all procedures is that solid chromium trioxide

has to be dissolved in water because chromium trioxide is obtained as a solid (manufacture

outside of the EU). This occurs with stirring without using heat or other energy input.

Expediently, the containers in which the mixing takes place are largely closed to avoid losses

and therefore additional expense.

Considered processes:

Releases to the environment (Environmental Release Category)

ERC2: Formulation of preparations (mixtures).

Worker activities (process categories).

PROC01: Use in closed process, no likelihood of exposure.

PROC03: Use in closed batch process (synthesis or formulation).

PROC05: Mixing or blending in batch processes for formulation of preparations* and articles

(multistage and/or significant contact).

PROC08b: Transfer of substance or preparation (charging/discharging) from/to vessels/large

containers at dedicated facilities.



PROC09: Transfer of substance or preparation into small containers (dedicated filling line,

including weighing).

PROC 0: Other, maintenance.

Product Category

PC14: Metal surface treatment products, including galvanic and electroplating products.

PC15: Non-metal-surface treatment products.

PC 19: Chemical intermediate products

In particular, there are the following contributing scenarios:

(1) Contributing scenario controlling environmental exposure: exposure of the environment

as a result of the formulation of preparations (mixtures).

(2) Contributing scenario controlling worker exposure: worker exposure when moving

substances or mixtures from storage containers into formulation machinery.

(3) Contributing scenario controlling worker exposure when mixing chromium trioxide in

aqueous formulations.

(4) Contributing scenario controlling worker exposure when maintaining formulation plants.

2.1.1 Contributing scenario (1) controlling environmental exposure: environmental

exposure when formulating preparations (mixtures).

This section describes releases to the environment that may occur as a result of the use of

chromium trioxide to formulate preparations for surface treatment. These releases may occur as

emissions to waste water or to the atmosphere. The applicable environmental legislation

assumes that the risk to the environment and population is adequately controlled because the

emission values fall significantly below the permitted values. This principle also applies here.

Emissions to the waste water at a site are treated by an industrial sewage treatment plant to

reduce the environmental emissions. In the sewage treatment plant the Cr(VI) is reduced to

Cr(III). The addition of alkaline or sulphidic compounds causes the precipitation of water-

insoluble chromium (III) compounds, which are sent to a landfill site or are sent for incineration

or recycling. Emissions to local water treatment plants are prevented by suitable measures that

are agreed with the competent local authorities. Alternatively, the waste water containing

chromium (VI) is taken by approved waste organisations. These are methods of disposal that

are approved by the authorities.



Emissions to the atmosphere are prevented using air scrubbers or other suitable technical

equipment. The effectiveness is ensured by regular control measurements. The emission

values are significantly below the permitted values.

Product characteristics

Before the manufacture of the preparation, the substance is a non-dusting solid. The substance

has a high melting point (196 °C) and has low volatility. After manufacturing the formulation, the

substance is liquid.

Alternatively, the substance can also be used at a higher concentration (up to 750 g/l) as a

liquid, aqueous solution, to produce dilutions.

Used quantities

The lowest quantity used at the operating site is a few kilograms a year; the total quantity up to

a maximum of 1 000 tonnes a year. The concentration of the substance in the final preparation

is usually in the range 0.1 g/l to 750 g/l.

Frequency and duration of use

The frequency of exposure is generally a maximum of 240 days a year, with working days of 8

hours.

Environmental factors that are not influenced by risk management

Emissions to local water purification plants are prevented by suitable measures that are agreed

with the competent local authorities. In Germany, 0.1 mg/l output is permitted.

Other existing conditions of use that influence environmental exposure

Batch manufacturing, mixing and packaging the formulation are performed under strictly

controlled conditions to minimise releases. Emissions in the exhaust air are scrubbed before

release. Waste water from cleaning the plant, from apparatus and equipment is fed back into

the process and added to subsequent batches.

As part of structural measures, safe barriers are created that prevent the substance being

released to the environment.

Technical conditions and measures at a process level (source) to prevent releases

The formulation of preparations is performed as far as possible in a closed process under

exhaust and external supply air, which ensures the effectiveness of the exhaust, to minimise

potential releases.



Technical on-site conditions and measures to reduce the restriction of discharges,

exhaust air emissions and releases to the soil

Waste water is discharged to the on-site sewage treatment plant. The permitted or statutory

discharge conditions are reliably maintained; permitted emissions do not result in adverse

changes.

As part of structural measures, safe barriers are created that prevent the substance being

released to the environment.

Organisational measure to prevent and limit releases on site

Employees are extensively trained to prevent accidental releases. Emissions are monitored to

ensure that the air concentrations remain below the officially permitted emission values.

Conditions and measures relating to local waste water treatment plants

The degree of purification in standard treatment plants is at least 99 %. The maximum

throughput is considered in consultation with the competent authorities.

Conditions and measures relating to the external treatment of waste for disposal

Residues from the air scrubber are sent for external waste treatment or on-site waste water

treatment, or are reused in the manufacturing process. Sewage sludge is recycled, incinerated

or sent to a landfill site. Cr(III) residues are sent as solid waste to a landfill site, for incineration

or recycling.

Conditions and measures relating to the external recovery of waste

External recovery of chromium trioxide from waste or residual substances is not envisaged.

2.1.2 Contributing scenario (2) controlling worker exposure for moving substances or

mixtures from storage containers to formulation plants

Exposure of workers as a result of transferring substances or preparations (mixture)

from storage containers to formulation plants.

This section describes the possible worker exposure during the formulation of preparations with

chromium trioxide. Workers are most likely subject to exposure during the transfer of

substances or preparations from storage containers to formulation plants. Suitable personal

protective equipment is available and its use is regulated by operating instructions.




Before the manufacture of the preparation, the substance is non-dusting in the form of flakes.

The substance has a high melting point (196 °C) and has low volatility. After manufacturing the

formulation, the substance is liquid.


liquid, aqueous solution, to produce dilutions. The required starting quantity of the

chromium (VI) solution in this case is ordered directly from the manufacturer in the correct

concentration and quantity.

Subsequent formulation takes place directly in the existing hazardous goods packaging (e.g.

IBC).

Used quantity

The largest quantity used at the operating site is a few kilograms a year; the planned total

quantity is a maximum of 1 000 tonnes a year. The concentration of the substance in the final

preparation is usually in the range 0.1 g/l to 750 g/l.

Frequency and duration of use/exposure

The frequency of exposure is generally a maximum of 240 days a year, with working days of 8

hours.

Other existing conditions of use that influence worker exposure

Transferring chromium trioxide to the formulation plants is performed in the presence of local

exhaust ventilation. Personal protective equipment is used in accordance with operating

instructions to avoid the possibility of dermal exposure during the transfer process.


Transferring chromium trioxide to the formulation plants is performed in the presence of local

exhaust ventilation. The preparation is entirely enclosed in the formulation plant.



The mixing container is sealed as far as possible. The main opening is used whilst employing local exhaust ventilation (for example, a funnel-shaped exhaust device on the right-hand side). Notes: One can also see part of the suitable personal protective equipment that is to be worn in accordance with the operating instructions to prevent dermal risks.

Technical conditions and measures to control the substance distribution from source to

worker

Local exhaust ventilation is always present during the transfer process and, in accordance with

the operating instructions, should be switched on before starting work and checked that it is

functioning correctly. External supply air ensures the effectiveness of the exhaust.

Organisational measures to prevent/limit release

Workers are extensively trained on safe handling and the use of suitable personal protective

equipment. Staff medical checks mean that effects on health are constantly monitored.

Conditions and measures relating to personal protection, hygiene and health

assessment

Protective gloves with full protection, washable or disposable protective suits, safety

shoes/rubber boots and eye protection are worn in addition to respiratory protection if the

system is not completely closed. Local exhaust ventilation with external supply air that ensures

effectiveness is operated on site to guarantee minimum exposure.



Example of suitable personal protective equipment to prevent dermal risks and risks to eyes.

2.1.3 Contributing scenario (3) controlling worker exposure when mixing chromium

trioxide in liquid formulations

During mixing, the main opening remains open for inserting a stirrer/mixing unit. Exposure is prevented by means of local exhaust ventilation (funnel-shaped exhaust device on the left-hand side).

Worker exposure as a result of mixing chromium trioxide in liquid formulations

This section describes the possible exposure of workers who are involved in mixing chromium

trioxide in liquid formulations in formulation plants. Worker exposure is minimised because this

activity takes place in a highly controlled, virtually closed (see image above) system. In addition,

because workers are scarcely at the site of exposure during the process because of the long

stirring and mixing processes, a negligible exposure dose is assumed. Nevertheless, suitable



personal protective equipment is worn and local exhaust ventilation is used to reduce the

exposure potential.






liquid, aqueous solution, to produce dilutions.

Used quantity

The largest quantity used at the operating site is a few kilograms a year; the planned total

quantity is a maximum of 1 000 tonnes a year. The concentration of the substance in the final

preparation is usually in the range 0.1 g/l to 750 g/l.


Workers work in shifts of 8 hours per day and generally work up to 240 days a year. It is

expected that worker contact with chromium trioxide during the mixing processes is very low as

a result of using appropriate exhaust technology and personal protective equipment. As a result,

only a brief exposure at a low level of exposure is expected.


Mixing chromium trioxide in liquid formulations in formulation plants is performed in a highly

controlled, virtually closed system. Local exhaust ventilation with external supply air, which

ensures the effectiveness, is used to minimise inhalation exposure. The personal protective

equipment, the use of which is described in the operating instructions, is used to minimise the

potential for dermal exposure during the mixing process.


Mixing chromium trioxide in liquid formulations in formulation plants takes place under local

exhaust ventilation. The preparation is virtually entirely enclosed (see above image) in the

formulation plant. Worker exposure is not expected.

Technical conditions and measures to control the substance distribution from source to

worker

Local exhaust ventilation with external supply air, which ensures the effectiveness, is used

during the mixing process.





equipment. Staff medical checks mean that effects on health are constantly monitored.


assessment

Protective gloves, where applicable with temporary full protective effect, washable or disposable

protective suits, and safety shoes/rubber boots are worn. Local exhaust ventilation is used at

the site of the mixing process.

2.1.4 Contributing scenario (5) controlling worker exposure when maintaining

formulation plants

Worker exposure when maintaining formulation plants

This section describes the possible exposure of workers when maintaining formulation plants

that are used to manufacture solutions containing chromium trioxide. Workers perform activities

to correctly maintain the proper functioning of the formulation plants. These activities include

cleaning the formulation plants, sampling, and repairing the system. During this work, local

exhaust ventilation (with external supply air to ensure effectiveness) is used and suitable

personal protective equipment (use regulated in operating instructions) is worn by workers to

minimise the potential risk of exposure.





Used quantities

The substance is not used in this scenario, rather work is performed on the equipment. During

maintenance, the plant is roughly cleaned and contains no solution containing chromium

trioxide that is effective by inhalation.


Maintenance is performed in cycles of 1 to 4 times a month. Maintenance work does not take

longer than one shift, usually maintenance is complete within a few hours.




Suitable protective gloves, possibly with temporary full protection, washable or disposable

protective suits, safety shoes/rubber boots and eye protection are also worn in addition to

respiratory protection for protection in the event of accidental contact, if the system is not

completely closed, for example during cleaning and maintenance work that is required for the

functioning of the formulation plants. Local exhaust ventilation is used to minimise the inhalation

exposure. External supply air ensures the effectiveness.


As already mentioned, precautions are taken when manufacturing solid preparations and

articles to minimise the exposure. Local exhaust ventilation is used, the effectiveness of which

is ensured by external supply air. Workers who are involved with cleaning and maintaining

formulation plants wear suitable personal protective equipment (with respiratory protection as

required) to prevent dermal and inhalation contact with the substance if exposure is possible.

Technical conditions and measures to control the distribution from source to worker

When cleaning and maintaining the closed formulation plants, workers wear suitable personal

protective equipment, including gloves, washable or disposable protective suits, safety

shoes/rubber boots and eye protection, to prevent accidental contact. All activities are

performed under controlled conditions with local exhaust ventilation to minimise the possibility of

inhalation exposure. External supply air ensures the effectiveness of the exhaust ventilation.



equipment. Staff medical checks mean that effects on health are monitored to ensure that the

exposure does not exceed acceptable levels and that the effectiveness of the protective

measures taken is sufficiently high.


assessment

Protective gloves with protection of greater than 90 %, washable or disposable protective suits,

safety shoes/rubber boots and eye protection are worn in addition to respiratory protection if the

system is not completely closed. Local exhaust ventilation with external supply air operates

when formulations are being manufactured.



2.1.5 Real exposure levels as a result of using risk minimisation measures

The following lists the results of a current exposure measurement when performing the

requested use in accordance with the production conditions described and presented in

sections 6.1.1 to 6.1.4:

Company(anonym-

ised)

Exposure level (without information on dose)[µg/m³] Cr(VI)

2014

o p

Measurement was taken to the left and right of the production tank at the operator position

Work procedures taken into account with the personal measurement:

- Preparation (10 min)- Manufacturing formulation and

mixing (60 min)- Cleaning/rinsing (10 min)

Formulator <0.017<0.015 (when rinsing)

<0.036

Measurement strategy (quoted from the report): ‘The aim was to measure the inhalation exposure of those involved, particularly in relation to chromium (VI), when formulating a chromium solution (chromium trioxide, author comment). We also took a personal air sample from the respiratory area of the affected worker, and a stationary measurement from the work area.’

Real, measured exposure level in a company that employs the requested use in accordance

with the descriptions of the exposure scenarios and risk minimisation measures from 6.1.1 to

6.1.4 (o=fixed measurement, p=personal measurement).

2.1.6 Guidelines for downstream users to assess whether they are within the limits

defined in the ES

Release to the environment:

The following conditions must be met to ensure work within the limits of the exposure scenario:

• Discharge into the atmosphere after air scrubbing must be below 0.05 mg/m³.

• If an on-site sewage treatment plant is used, the sewage sludge must not reach

unsealed soil.

• If an on-site sewage treatment plant is used, the emissions into the surface water

must not exceed 1 kg Cr(III) per day.



• Residues from air scrubbing must be sent for external waste treatment, on-site

sewage treatment or for recycling in the production process.

• Cr(III) residues are sent as solid waste to a landfill site, for incineration or recycling.

These are methods of disposal that are approved by the authorities.

Worker exposure:

The following conditions must be met to ensure work within the limits of the exposure scenario:

• formulation weighing, charging, mixing and manufacturing takes place in closed

operating areas.

• Weighing and charging chromium trioxide into the reactor vessel is performed in the

presence of local exhaust ventilation (LEV) with external supply air.

• Local exhaust ventilation with external supply air should be present in the weighing

and charging areas and in the reactor vessel housing during activities including cleaning,

general reactor maintenance, mixing activities and manufacturing formulations.

• Workers must always wear suitable personal protective equipment (e.g. protective

gloves, eye protection, safety shoes/rubber boots and washable or disposable safety

suits). The use must be stipulated in operating instructions.

• In areas with dermal exposure, protective gloves of sufficient protection and washable

or disposable protective suits must be worn.

• Regular health monitoring takes place to establish the possible exposure.

Consequently, the effectiveness of the implemented safety measures can be reviewed

and any need for optimisation determined.

2.2 Discharge into the environment

2.2.1 Limitation of the scope of assessment

Only the possibility of discharge via exhaust air is discussed for the intended use of chromium

trioxide to formulate aqueous solutions in accordance with the requested use.

Discharge via sludge is not possible because the substance is entirely converted from the solid

state to the dissolved state via simple solution. This means that only rinsing solutions of very

low concentrations result, which are treated by reducing to Cr(III) compounds. There is no

indirect or direct discharge of solutions containing chromium trioxide.



2.2.2 Discharge via exhaust air after cleaning by in-house exhaust air treatment plants

The German immission control legislation is initially determined by European legislation.

Several regulations of the EEC (Rome Treaty) and secondary community legislation give

essential requirements for national immission control legislation. The German federal regulation

for the immission control legislation, the Bundesimmissionsschutzgesetz (BlmSchG) [Federal

Immission Control Act], with its now 36 legal regulations, can be used as an example of national

implementation.

The federal regulations include general administrative provisions, particularly the technical

instructions on maintaining air purity (TA Luft) and on the protection against noise (TA Lärm)

based on Article 48 BImSchG or Article 16 Gewerbeordnung (GewO) [Trade, Commerce and

Industry Regulation Act] (old version) in conjunction with Article 66 II BImSchG. Administrative

provisions are only actually effective within public authorities. However, a legally binding effect

is being discussed for TA Luft and TA Lärm. Previous jurisdiction viewed the technical

instructions as an anticipated expert opinion. From this perspective, there would not be any

legally binding effect. It served merely as a decision-making aid. Today, the prevailing

jurisdiction recognises the technical instructions as having a binding character. For this reason

the limit values applicable in TA Luft16) also apply to the present analysis. As amended on

24 July 2002, in Section 5.2.7.1.1 for chromium (VI) compounds (specified as chromium) it

defines limit values in the exhaust gas as ‘requirements to provide protection against harmful

effects on the environment’:

maximum mass flow: 0.15 g/h

maximum mass concentration: 0.05 mg/m³

These values are the starting point of dispersion calculations for chromate under various

dispersion conditions.22) The report compares calculation results using fictitious presumptions

with calculation results of real, measured exhaust gas values.

The following illustrative results should be discussed (22), page 9, 10):

http://www.juraforum.de/lexikon/rechtsprechung

http://www.juraforum.de/lexikon/ta-luft

http://www.juraforum.de/lexikon/verwaltungsvorschrift

http://www.juraforum.de/lexikon/verwaltungsvorschrift

http://www.juraforum.de/gesetze/bimschg/66-fortgeltung-von-vorschriften

http://www.juraforum.de/gesetze/gewo/

http://www.juraforum.de/gesetze/gewo/

http://www.juraforum.de/gesetze/bimschg/48-verwaltungsvorschriften

http://www.juraforum.de/lexikon/laerm



Distance from receptor point

Fictitious example calculation Real exhaust gas measurements

V = 50 000 Nm³/h, humidity 50 %, exhaust gas concentration C = 0.05 mg/m³ Cr

V = 50 000 Nm³/h, humidity 50 %, exhaust gas concentration C = 0.011 mg/m³ = 11 µg/m3 Cr

m ng/m³ ng/m³

50 34.625 8.345

100 30.496 7.003

200 12.792 2.874

300 6.806 1.519

500 2.917 0.647

1000 0.890 0.197

Dispersion results, worst case (= maximum mass flow)

Distance from receptor point

Fictitious example calculations Real exhaust gas measurements

V = 5 000 Nm³/h, humidity 20 %, exhaust gas concentration C = 0.05 mg/m³ Cr

V = 5 000 Nm³/h, humidity 50 %, exhaust gasconcentration C = 0.05 mg/m³ Cr

V = 6 000 Nm³/h, humidity 2 %, exhaust gas concentration C = 0.003 mg/m³ = 3jµg/m3 Cr

m ng/m³ ng/m³ ng/m³

50 6.673 6.449 0.124

100 4.108 4.048 0.184

200 1.472 1.462 0.084

300 0.746 0.743 0.045

500 0.308 0.307 0.019

1000 0.092 0.091 0.006

Dispersion results, best case (= low mass flow)



Firstly, please note that the calculations do not take into account a reduction in concentration as

a result of chemical reactions in the environment, for example, reduction to Cr(III) compounds.

As the compounds are discharged to the environment in a humid environment (chromium

trioxide is not gaseous, but is transported in an aerosol), they are expected to rapidly reduce via

omnipresent carbon compounds. The mass concentrations that occur in real life in the

environment of the receptor point may therefore be significantly lower and subside much more

quickly. It is scarcely possible to measure these levels as a result of the extremely low

concentrations in the nano and picogram range.

Even under unfavourable conditions, the real exhaust gas measurements at the receptor point

amount to a mass concentration in the wind direction of below 10 ng/m3, even at a distance of

50 m from the receptor point, i.e. from the exhaust air outlet. In cases of lower mass flow and

total exhaust air volume — such as would be expected from SMEs in the surface treatment

industry — levels are far below this value. The level is between 1.0 ng/m³ and 1.5 ng/m³ even

beyond 50 m. Beyond 100 m the level generally drops below 1 ng/m³, i.e. the mass

concentration already reaches picogram levels.

Risk minimisation measure for discharge to the environment via exhaust air: chromium exhaust air scrubber



Table 2. Risk characterisation relating to the environment

Scope of protection Type of risk Hazard assessmentFresh water Chromium trioxide, as a compound

that is readily water soluble, is rapidly reduced in the environment to non-hazardous Cr(III) species. As a result of low exposure outside of the assessed plants, it is not expected to have a negative impact on drinking water/fresh water.

The basis is hard limits (Germany: Cr (total) = 0.5 mg/l, Cr(VI) = 0.1 mg/l), which are maintained at non-hazardous concentrations via external and on-site control.

Disposed of as non-critical Cr(III) compounds.

No significant risk can be established as levels demonstrably comply with specified limit values.

Sediment (fresh water)Chromium trioxide, as a result of its rapid reduction to Cr(III), cannot usually be incorporated permanently as sediment.

In addition, existing regulations and both internal and third-party monitoring prevent considerable quantities of the substance being transferred to the environment.

Disposed of as non-critical Cr(III) compounds.

Negligible

Sea water Similar to fresh water Negligible

Sediment (sea water) Similar to fresh water sediment Negligible

Municipal sewage treatment

The substance does not reach the municipal sewage treatment plants because there are just two key waste strategies in the companies of the applicant:

1. On-site treatment by reduction to Cr(III) compounds

2. Disposal of liquids containing chromium trioxide by certified waste disposal companies

Compounds are not discharged to open water as a result of statutory provisions.

irrelevant

Air Emissions are regularly checked and maintained at a low level as a result of prescribed exhaust air purification plants. National air limit values (Germany: Cr(total) = 1 mg/m³, Cr(VI) = 0.05 mg/m³) ensure non-critical release. In addition, possible

By verifying compliance with limit values, no risk can be established.



traces in the environment are rapidly reduced to non-critical Cr(III).

Agricultural soil As a result of the rapid reduction in organically enriched soils, the compound has a short retention time; there is no accumulation for the same reason.

irrelevant

Evaluation of the approach:

It may be noted that the chemical behaviour of chromium trioxide makes it impossible for the

compound to accumulate in the environment. In addition, strict emission specifications (e.g.

BlmSchG in Germany) prevent the general release of considerable quantities. Both factors

mean that an appreciable impact on the environment is reliably prevented.

2.3 Impact on humans via the environment

In the preceding section, we estimated the risk levels for the general population using

dispersion calculations. If you use the dose-response relationship2) for chromium trioxide to

assess the risk, for 1 ng/m³ this gives a risk of 12:1 000 000 (corrected to 52 weeks, 7

days/week and 16 hours/day presence in the affected area). Even for large-scale plants the risk

is below 12:100 000.

The risk levels only apply to residents that are directly affected, i.e. for the general population

that is permanently resident in the immediate vicinity (< 500 m) of the operating sites and is

present for the majority of the day.

Beyond this limit, the risk quickly falls by a factor of 10 or more. Therefore, a risk level of

12:1 000 000 to 12:10 000 000 maximum must be assumed.

In the adjacent area in question, there are only isolated residential areas. Predominantly, the

plants are operated in commercial areas or mixed-use zones, in which the general population is

not affected.

Overall therefore, despite the relatively high number of companies processing chromium

trioxide, only a fraction of the total population is affected by the aforementioned emissions,

particularly as the risk also drops significantly even at a short distance from the receptor point

due to the reactivity of chromium trioxide into non-hazardous chromium (III) compounds.

It appears that the standard, legislative exhaust gas conditions eliminate the risk of discharge

into the environment. To balance the established additional risk of 12:1 000 000 to

12:10 000 000, for example, in Germany — as shown later — there is a basic, omnipresent risk

of the general population developing lung cancer of 50 000:80 000 000 = 12:19 200.



3 Explanations on risk assessment relating to the toxicological risk at the workplace

3.1 General risk assessment of chromium trioxide in surface finishing

The following section intends to estimate the level of the real additional risk from exposure with

chromium trioxide in surface-finishing companies, focusing on electroplating, focusing on

companies in the VECCO e.V. consortium. Officially available data and comparative data from

VECCO e.V. companies form the basis of this risk assessment.

As explained in the prioritisation and in the Annex XV document, the assessed risk can be

reduced to respiratory intake and therefore to the disease of lung cancer. All other possible

diseases caused by the effect of chromium trioxide can be ignored. The exposure scenarios

described in the preceding sections and their assessment also reach the same conclusion.

The aim of the assessment must be to establish the additional risk that is expected for the

affected worker group beyond the general risk of the general population. A similar approach

forms the basis of the study by Seidler et al.,17) which ultimately resulted in establishing the

dose-response relationship.

The following section uses various data to best measure the quantitative values of this

additional risk.

3.2 Officially recognised occupational disease incidence in Germany relating to

chromium and its compounds as the cause

The Zentrum der Krebsregisterdaten [Centre for Cancer Registry Data] at the Robert Koch

Institute (RKI) regularly publishes information on the incidence of disease in Germany based on

the Bundeskrebsregisterdatengesetz (BKRG, 2009) [Federal Cancer Registry Data Act]. It can

be viewed at http://www.krebsdaten.de/Krebs/EN/Home/homepage_node.html.

In particular, data is recorded on the annual incidence of new cases of lung cancer in the

German population.

http://www.krebsdaten.de/Krebs/EN/Content/Cancer_sites/Lung_cancer/lung_cancer_node.html

In 2008, about 50 000 new cases of lung cancer were diagnosed. In 2012, the estimated

number was virtually the same so this can be used as the average expected value of frequency

of annual new cases.

At around 80 million citizens, the risk of developing lung cancer can therefore be estimated as

having a probability of approximately 50 000:80 000 000 = 1:1 600 = 4:6 400. The risk is

therefore approx. 0.625 per thousand per citizen and year.

This result should be compared with the probability of developing lung cancer as a result of

chromium trioxide exposure at the workplace. Generously, the Bundesministerium für Arbeit

http://www.krebsdaten.de/Krebs/EN/Content/Cancer_sites/Lung_cancer/lung_cancer_node.html

http://www.krebsdaten.de/Krebs/EN/Home/homepage_node.html



und Soziales [German Federal Ministry for Labour and Social Affairs] publishes an annual

report on the incidence of occupational illness in Germany: ‘Sicherheit und Gesundheit bei der

Arbeit — Unfallverhütungsbericht Arbeit’ [Safety and health at work — occupational accident

prevention report] (also abbreviated to Suga). As an example, Suga from 20105) and 201221)

were consulted which, in numerous tables, reported on factors such as the incidence of new

cases of occupational illness (page 77 ff). For example, Section TC2 (page 104 ff) presents

data on officially recognised cases of occupational illness.

Unfortunately, the data is only reported in categories. Consequently, category (BK-Nr.) 1103

contains all diseases that could be caused by chromium and its compounds. Reference is not

given solely to chromium trioxide or to a single disease (e.g. lung cancer).

Nevertheless, it can already be seen that throughout German industry in 2008 to 2012 only

14, 16, 13, 21 and 23 cases of disease respectively were recognised — which, however, in no

way relates to lung cancer triggered by chromium dioxide (page 104 or 106)! This is all the more

remarkable because these years would have to account for possible long-term effects of the

high exposures from the 1970s and earlier.

Upon enquiring at the REACH helpdesk we learnt that the data in Suga, similarly to that of the

Annex XV document on chromium trioxide, came from the data pool of the DGVU (Deutscher

Unfallversicherungsverband [German accident prevent association]). The Suga was created by

the same institute as the Annex XV document for chromium trioxide, the BAuA (Bundesanstalt

für Arbeitssicherheit und Arbeitsmedizin [Federal Institute for Occupational Safety and

Health])1),21).

Upon further enquiry, detailed data was reported on the values of category (BK-Nr.) 1103 for

2008 to 2012.19), 20)

In the provided tables no direct link could be found to chromium trioxide or lung cancer.

However, (Table 4, column ‘U’) the description ‘82239 other operators of metal surface

treatment and coating machinery, enamellers, electroplaters, metal’, included electroplating but

not exclusively. In this category for 2008 to 2010 there was a single case of recognised

occupational illness as a result of chromium and its compounds. It should also be noted

that the type of illness and the type of operation in which it occurred is not recorded in the

available data. Two further cases were reported for 2011 and 2012.

However, overall in 2008 to 2010 in all sectors of German industry, 18 malignant tumours

occurred in an environment where chromium and its compounds were used (rows 23–25,

column F: ‘C34.9 malignant growth in the bronchus or lungs, n.e.i.’5)), in 2011 and 2012 there

were 16 in total (row 21–23, column F21)).

This data does not confirm the often assumed significantly elevated risk in electroplating

businesses. It cannot be assumed from this data that the electroplating use of chromium trioxide



necessarily leads to a considerable incidence of illness; it is not certain whether the individual,

reported cases of the higher-level field 82239 occurred in electroplating; neither has this been

explicitly stated by any of the involved authorities (DGUV, BAuA, BMAS). Even if more workers

are employed in other sectors, this cannot be used here as an explanation because it is officially

documented that in a maximum of three years, one incident of an occupational illness can be

assumed for 3 (years) x 4 500 employees. As it is not known to which exposure the recognised

incidences of illness were subjected, it is not possible to make a clear statement. However, it is

known18) that in some companies (not just electroplating) there was obviously very high

exposure. This results in a disproportionate risk, which explains the individual cases. Even

outside of electroplating, the Annex XV document1) on pages 26 and 29 reports significantly

excessive exposure levels despite the lower number of official measurements. For the

remaining companies, it cannot be excluded that the far lower exposures already ensure

reasonable risk management.

The presented correlations make it necessary to consider the risk in relation to the operation, as

the few observed incidents of illness can very likely be attributed to large upward deviations of

exposure to high levels.

Nevertheless, if we assume that the occupational illness incident specified in the Suga report

may be lung cancer in the electroplating industry that uses chromium trioxide, then the

prevailing risk in this industry from 2008 to 2010 can be estimated as follows:

According to the Annex XV report, about 45 000 workers are employed in the German metal

treatment industry. For Europe, this calculation of the BAuA assumes a 10 % proportion of

installations in the surface-treatment industry that uses chromium trioxide (1), page 15). If we

also accept this estimation for Germany, these assumptions result in about 4 500 employees

that are exposed to chromium trioxide exposure in surface engineering.

This number of workers is compared with a single officially recognised case of illness in 3 years,

accordingly the risk is 1: (3 x 4 500) = 1:13 500 or 0.074 per thousand per worker and year.

Accordingly, this direct calculation results in an overall lower risk of illness at work than in the

general population. This result can be attributed to the low number of cases and thereby the

large statistical confidence interval. Nevertheless, it can be concluded that the additional risk of

developing chromium trioxide-induced lung cancer in German operations of the electroplating

industry that process chromium trioxide can only represent a fraction of the general risk —

otherwise a larger proportion would be observed.



In the further explanations, the following facts must be noted, which corroborate the next

results:

- for 150 000 new incidents of lung cancer in Germany in three years, the prevention of a

single case — if it actually was related to the relevant case of lung cancer triggered by

the surface-treatment industry that uses chromium trioxide — could not be statistically

determined by restricting the use of chromium trioxide in the surface-treatment industry

in the future. Even a complete ban could not provide any measurable or demonstrable

result. Should only individual uses be approved, the impact of the measure could not be

determined because this individual case would not be reliably avoided and would not be

statistically demonstrable.

- It should be noted that this risk of occupational illness materialised under strict

regulations within Germany. The German Employers’ Liability Insurance Associations

did not consider it necessary to regularly monitor a company in the relevant time period

once its measured chromium trioxide air concentration was below 5 µg/m.3 No further

measures were considered necessary. The specified value corresponded to 10 % of the

limit value that applied for a long time in Germany of 50 µg/m³. In addition, long-term

consequences (especially typical in the form of lung cancer) from the years of possible

high exposure (before 1990) could apparently not be established and is therefore not

expected in future either.

For the further considerations it appears plausible therefore, as a result of this official

and real, practical data on recognised occupational illnesses, that the observed or non-

observed incidence of illness is attributed to compliance with the maximum level of

5 µg/m3 in the air. Even at this value the risk is minimised as it is generally known that

individual companies, despite regular monitoring, are significantly above this permitted

maximum value (5 µg/m3)! The statements from this risk assessment should therefore be

considered as particularly supported.

3.3 Incidence of new cases of illness according to Hunt

According to the OECD study by Hunt, A3) the following general value (‘unit risk factor’, URF)

can be assumed for the lung cancer rate for pure exposure to chromium trioxide (page 32 1):

�� = 0.012��[��70��ℎ��1 µ� �³⁄ ��]URF = 0.012 cancers [per person in 70 years at 1 (µg)/m³ air concentration]

1

it should be noted that the use of the ‘unit risk’ factor is based on experience with other kinds of exposure of a general kind (for example ozone). The source cited by Hunt also states that the unit risk analysis is hardly necessary for concentrations < 0.8 µg/m³. For this reason, the determined values are used for a precautionary estimation and therefore for a qualitative comparison with the values derived later from the dose-response relationship.



In words: if a person is exposed to a chromium trioxide concentration of 1 µg/m³ continuously

for 70 years, their risk of developing cancer is assessed as being 0.012:1 or about 1:80 or

1.2 %.

If this value is corrected for the standard working hours in Germany, it is reasonable to assume

the following:

● working lifetime = 40 years

● annual number of work days = 240 days = 46 weeks á 5 days

● shift working time = 8 (exposure) hours

Which calculates to a probability based on the hours of work of

��,1µ� = 0.012�� ×40

70×240

365×8

24= 0.0015��

URFwork,1 µg = 0.012 cancers × 40/70 × 240/365 × 8/24 = 0.0015 cancers

If you consider that for a long time a value of 5 µg/m³ was recognised to be the risk threshold

(i.e. the German Employers’ Liability Insurance Associations did not deem any further risk

minimisation measures to be necessary) and therefore the value can be assumed to be the

target quantity of the ‘worst case’, this gives the following risk value (a linear risk increase is

assumed):

��,5µ� = 0.0015�� × 5 = 0.0075��

URFwork,5 µg = 0.0015 cancers × 5 = 0.0075 cancers

For persistent chromium trioxide exposure at the workplace of 5 µg/m³ in the air, there is a risk

of 0.75 % or 1: 133 for an individual worker to develop lung cancer over the course of their life.

The calculated value can be converted to the risk per year.

��,5µ�,�� = 0.0075�� ÷ 40 = 1.875 × 10�4��/�

URF5 µg,annual = 0.0075 cancers ÷ 40 = 1.875 × 10-4 cancers/a



For companies of different sizes and exposure situations, the following risk factors (= triggered

incidence of illness per year) can therefore be calculated:

0.1 µg/m³ 0.5 µg/m³ 1 µg/m³ 2.5 µg/m³ 5 µg/m³

10 exp. W 0.000038 0.000188 0.00038 0.00094 0.00188

25 exp. W 0.000094 0.00046 0.00094 0.0024 0.0046

50 exp. W 0.000188 0.00094 0.00188 0.0046 0.0094

100 exp. W 0.00038 0.00188 0.0038 0.0094 0.0188

150 exp. W 0.00056 0.0028 0.0056 0.014 0.028

250 exp. W 0.00094 0.0046 0.0094 0.024 0.046

500 exp. W 0.00188 0.0094 0.0188 0.046 0.094

triggered incidence of illness (calculated from Hunt's URF) per year (exp. W = exposed

workers), at 8 hours exposure

By way of illustration, the number of operating years can be calculated, after which a statistical

incident of illness is likely to occur in the various operational situations:

10 exp. W 25 exp. W 50 exp. W

100 exp.

W

150 exp.

W

250 exp.

W

500 exp.

W

0.1 µg/m³ 26 316 10 639 5 319 2 632 1 786 1 064 532

1 µg/m³ 2 632 1 064 532 263 179 107 53

5 µg/m³ 532 218 107 53 36 22 11

Duration (operating time in years) until the occurrence of an incident of illness (calculated

from Hunt's URF); ‘statistical first case limit’.

Expressed in words this means that each worker that is exposed on a long-term basis at work to

an exposure of 5 µg/m³ chromium trioxide has a risk of developing lung cancer in the current

year of URF = 0.0001875. For approximately 5 333 workers, the risk becomes 1; even at a

maximum level of 50 (exposed) workers in an electroplating company (which in practice,

can be virtually ruled out) there is therefore a risk of just approx. 0.01 that an incident of

lung cancer will be triggered per year — this corresponds to one (statistical) case in

approx. 100 years (see table above). The green highlighted fields in the above table identify

all those cases in which illness is expected to occur in a company size that corresponds to the



standard electroplating companies. You can see that every statistically expected qualifying

period until the first case of illness is far beyond the expected period of company existence!

If we assume 4 500 workers in the Federal Republic of Germany (see Annex XV document),

then this calculation gives far fewer than one single incident of lung cancer per year, which

confirms the results of Suga.

The safety measures of the formerly applicable regulations implemented, for example, in

VECCO e.V. companies have an impact (see the chronological development of the table in

2.1.2.3) and reduce the risk to an extent that is barely measurable. In any case, for this risk too,

even a complete ban on chromium trioxide would not produce any measurable effect compared

with the general rate of illness.

3.4 Categorisation of companies based on the dose-response relationship

3.4.1 Preliminary remarks on assessing risk according to a dose-response relationship

Authorising a substance use in accordance with REACH requires looking at the situation from

the perspective of the applicant company — this becomes clear in Article 60(4). The risk, based

on the use, is accordingly use and company specific. Company management, process

management and plant facilities are then of key importance.

The dose-response curve2) also changes the perspective. An equal (maximum) exposure level

for all SVHC-exposed workers is no longer assumed, instead consideration is given to the

disease-triggering dose! Consequently, the exposure time is also taken into account to assess

the likelihood of a negative impact on health.

3.4.1.1 Critical assessment of the basis of the dose-response relationship

The dose-response relationship is an attempt to quantitatively link the risk of illness as a result

of the use or exposure of an SVHC with the ingested dose. It was derived from a study17) that as

a meta-study re-evaluated epidemiological data from different sources. Several studies were

rejected for various reasons and the conclusions taken from two remaining studies. The

observed cohorts in these studies came from Cr(VI) production, however, not from a surface

engineering use, for example. Thus, observations are related to dusty substances, however, not

to aerosols, which typically occur in individual surface-treatment applications.

The subsequent evaluation (potentially only as a result of legally prescribed access) of the data

of the German MEGA database that forms the basis of the Annex XV document, suggests, for

example, that systematic measurement differences between the official measurements taken by

German Employers’ Liability Insurance Associations are apparently caused by the sampling

systems used.24) The statistical evaluation of the same data has also shown a large



measurement uncertainty,24) which hardly allows a correct assessment of the effective

exposures, at least below 1 µg/m³.

In addition, measurement results within Europe are difficult to compare. For example, the

measurement locations are not uniformly defined. The German Employers’ Liability Insurance

Associations generally measure next to the emitting plant section whereas in surface

engineering in England measurements are taken 30 cm above the surface of the bath.

Differences are unavoidable and the measurement above the surface of the bath certainly does

not produce a value relating to workplace exposure.

If you then consider the different types of exposure (dust vs. aerosol), the applicability of the

study17) for the use in surface engineering may be questionable.

In April 2014, another detailed consideration on the available epidemiological data or studies

was published.25) The author was the same institution that had prepared the Annex XV

document on Cr(VI), and who ordered and coordinated the study.17) After the uncertainties were

illustrated in detail in 26), this detailed justification of national technical regulations for hazardous

substances also led to questionable results. The risk 4:1 000 equates to an exposure of 1 µg/m³

over 40 working years. However, this value is not derived. Instead, the value is taken25), page 31

from a study by Birk et al. 27), which was explicitly excluded by 17) because it gave no air

measurements and is characterised by 25) itself as having uncertainties and deficiencies.

Nevertheless, 17) is the basis for the European evaluation (the dose-response relationship).

As an applicant therefore, we find ourselves in the situation that there are officially accepted

studies that exclude and contradict each other. These contradictions can be found in most of

the studies on the subject.

In 25) this contradiction is apparently resolved by the fact that all studies — irrespective of their

specific deficiencies — correlate the risk 4:1 000 to the exposure value 1 µg/m³. This correlation

is not conclusive anywhere. The conclusion would be more scientifically probable if any of the

studies had recorded the sought-after value. It is more likely that some kind of average value of

the background emission is specified, potentially at the threshold of measurement? Above all,

the fact is that the exposure levels in low ranges (< 5 µg/m³) cannot be compared with any

incidence of illness, as already shown. Epidemiological predictions are therefore not possible

while toxicological findings have apparently reached their limits. Evidently, it is difficult to use

laboratory experiments for predictions when real conditions deviate too far from the laboratory

parameters.

The defined dose-response relationship should therefore be considered as a kind of ‘emergency

solution’. It can be regarded as a way of interpreting the overall results of the literature studies

and can therefore form a basis for discussion, however, it may not be considered conclusive

and must also be regarded in particular as a starting point for targeted investigations. This is

particularly clear in a recently published overview from the International Agency for Research on



Cancer (IARC).29) This reports (page 152) measurements from different industries and

technologies. It is amazing that even measurements in the milligram range (!) are noted. These

kind of values cannot be used as the basis for assessing the risk of exposures that are more

than a thousand times lower.

If you follow the dose-response relationship then the values determined in 29) would immediately

trigger illness; for according to the dose-response relationship, the risk from an exposure

concentration of 250 µg/m³ assumes a value of 1, i.e. every exposed person would develop lung

cancer with 40 years of exposure. From 10 mg/m³ this would occur in the first year, from

500 mg/m³ already in the first week. In 29), however, values up to 25 000 mg were reported even

in 1990–2000 which, according to this interpretation, would certainly have meant that any

exposed person would develop lung cancer. However, it is not reported that unexpectedly high

numbers of people suffering illness were observed.

With this in mind, the applicant accepts the dose-response relationship and uses it as the basis

for the present CSR of the application. The applicant commits to actively supporting the

generation of scientifically meaningful results (see section 1.4.1). However, on the current

basis, the applicant considers it imperative to carefully consider the economic

consequences of any restrictive measures because the level of the real risk and the

actual impact of any measures cannot obviously be reliably and quantitatively

determined — especially in the typically applicable concentration ranges of < 5 µg/m³.

The requested use is a sum of different applications that may vary greatly in chronological and

quantitative use. This flexibility is essential to the business model of a surface-finishing service

provider. They process third-party components and modify their surface characteristics in the

most diverse form, using chromium trioxide in various applications. Different companies offering

this type of service can only be differentiated in their exposure or dose. Therefore, the actual

increased risk for the worker cannot — as shown — be reliably defined at the specified level of

exposure <= 5 µg/m³. For this reason, the application relates to the current ongoing discussion

and is based on a maximum dose for the requested review period. After the review period a

new application will be necessary for the hopefully recognised, meaningful and representative

studies on the actually observed elevated risk in using chromium trioxide in aerosol form.

3.4.2 Application of the dose-response relationship

The dose-response curve, irrespective of its quantitative correctness, logically raises the

question of from what level of exposure illness could result from exposure periods that arise in

practice. In this case it is a suitable starting point for discussing the possible risk, perhaps

providing a rough estimation even if it cannot be quantitatively reliably determined. It provides

the option of estimating for individual companies whether there is a real statistical risk of illness



in a given operation during the assumed duration of the existence of the company or the

production plant that carries chromium trioxide. As explained initially, company management,

process management and plant facilities then become important because via the three target

parameters ‘number of exposed workers’, ‘exposure period’ and ‘exposure level’, the risk can be

directly influenced by risk minimisation measures.

In the following explanations, the following principle is therefore used as a logical consequence

of the risk assessment: if the necessary time to trigger an illness at a given dose in the

reasonably assumed operating period (this application assumes a maximum of 50 operating

years; therefore 10 years longer than the assumed duration of exposure of the dose-response

relationship) of the use is not achieved, it is possible to have an adequately controlled risk, if not

entirely likely; for during the operating period there is no reason to suppose that workers will

develop an illness during their lifetime! We call this statistical circumstance ‘statistical first case

limit’.

The following explanations will therefore establish the necessary conditions for the requested

application, to ensure the ‘statistical first case limit’. Measures to further reduce this ‘statistical

first case limit’ are not appropriate because it is not possible to measurably check the effect of

the measures.

3.5 Quantitative results from applying the dose-response relationship (DSR)

The dose-response relationship according to ECHA9) defines the following correlation:

Excess lifetime (up to age 89) lung cancer risk estimates for workers

exposed at different 8h-TWA concentrations of Cr(VI) for 40 years

TWA Cr(VI) exposure concentration(μg/m³)

Excess lung cancer risk in EU workers(x10-3)

25 100 12.5 50 10 40 5 20

2.5 10 1 4

0.5 2 0.25 1 0.1 0.4 0.01 0.04



The dose-response relationship makes it possible to calculate values for the annual probability

of triggering a new case of illness. In addition, the values from the ‘dose-response relationship’

should be corrected with the standard company duration and level of exposure and divided by

40 (40 = maximum timespan of a possible disease development. This produces the following

table:

In 6.1.5 the measurement results were reported from the real implementation of the requested

use; the following table lists the probability of occurrence and the ‘statistical first case limit’:

Exposure level (without information on dose) [µg/m³] Cr(VI)

2014

fixed personal

<0.017<0.015 (when rinsing)

<0.036

Probability of occurrence per year per exposed worker(exposure duration/8 )* exposure level * 4: 1 000 : 40 years

<0.0000017<0.0000015

<0.0000036

Example of the ‘statistical first case limit’ for a company with 10 exposed workers (operating years)

>5.9 x 104 = 59 000 years>6.7 x 104 = 67 000 years

>2.8 x 104 = 28 000 years

Real risk assessment of the requested use using real measured exposure level; assumed maximum exposure period = 8 hours/day

4 Estimation of the risk based on physico-chemical properties

Chromium trioxide has oxidising properties in just the solid state. The vast proportion of

chromium trioxide and chromates are handled in the liquid, dissolved physical form, which does

not cause any further physico-chemical hazards.

4.1 General information on risk management relating to toxicological hazards

The handling of chromium trioxide and related substances is regulated by diverse legislation,

which is implemented in companies in a similar way. Structural features are dependent upon the

respective specific circumstances in terms of space requirement and the necessary workflow.



In general, three risk management strategies should be followed:

1. Protection against dermal contact

2. Protection against inhalation

3. General hygiene at work

At the same time, routine and extraordinary operating situations must be considered. The latter

includes, for example, scheduled and unscheduled cleaning work.

In relation to point 1. Protection against dermal contact

Companies have general and specific operating instructions on handling hazardous substances.

They are derived from, and take into account the information in the supplier's safety data

sheets. The basis of the measures are hazard assessments (see the appendix for an example).

Further requirements are specified in the exposure scenarios (see above).

4.2 General information on risk management relating to physico-chemical hazards

Solid chromium trioxide and chromates are stored separately to combustible substances in their

own storage rooms.

4.3 Risk to consumers

The substance is only used in production sites. There is no consumer use. There is therefore no

risk.

4.4 Notes on exposure data:

The described measures mean that workplace exposure can be reliably maintained far below

5 µg/m3. This value suggests that the risk is reasonably controlled (see also 7)).

In 8), some other conclusions are drawn and the author suggests a clearly identifiable risk.

However, the latter is only possible at elevated levels of exposure as a result of not properly

implementing the statutory provisions in terms of exhaust air management and protective

measures. By observing the applicable provisions, exposure can be controlled to a low-risk

range.



4.5 Conclusions on risk characterisation:

The section ‘Quantitative results from applying the dose-response relationship’ showed that

adhering to a maximum exposure level of 5µg/m3 results in a well documented and controlled

real risk at the workplace. Applications in companies that feature lower levels of exposure and

also low periods spent in the exposure area have a significantly reduced risk.

Furthermore, the environmental protection measures, especially exhaust air and waste

regulations, are suitable for preventing the risk to the environment and subsequently for

[workers]. The low quantities that cannot be sent for processing do not represent any

appreciable risk.

Overall, it can be noted that the risk minimisation measures provided and presupposed in this

dossier ensure reasonable control of the risk in every respect.

Consumers do not come into contact with the SVHC. There is therefore no risk to consumers.

The described measures mean that workplace exposure can be reliably maintained far below

0.1 µg/m3. Measurements are taken according to regulations with standard operational

equipment (see following table).

In this case, in addition to a personal measurement, two site-specific measurements were taken during the entire potential exposure period. The measuring equipment was positioned in each case in relation to the exposure (exposure formulation and exposure cleaning).



5 REFERENCES

1) PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE AS A CMR CAT 1 OR 2, PBT, vPvB OR A SUBSTANCE OF AN EQUIVALENT LEVEL OF CONCERN, Annex XV Document August 2010

2) APPLICATION FOR AUTHORISATION: ESTABLISHING A REFERENCE DOSE RESPONSE RELATIONSHIP FOR CARCINOGENICITY OF HEXAVALENT CHROMIUM, RAC/27/2013/06 Rev. 1, 2013/12/04

3) Hunt, A. (2011), ‘Policy Interventions to Address Health Impacts Associated with Air Pollution, Unsafe Water Supply and Sanitation, and Hazardous Chemicals’, OECD Environment Working Papers, No 35, OECD Publishing. http://www.oecd.org/env/tools-evaluation/49453368.pdf

4) http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1007816/pdf/brjindmed00156-0034.pdf

5) http://www.baua.de/de/Publikationen/Fachbeitraege/Suga-2010.pdf?__blob=publicationFile&v=7

6) BG ETEM [German employers’ liability insurance association for the energy, textile, electrical, and media products sector] study or presentation

7) Annex XV document

8) WHO Regional Publications, European Series, No 91, 2nd Edition, 2000

9) http://www.euro.who.int/__data/assets/pdf_file/0005/74732/E71922.pdf

10) EN 374; http://www.anselleurope.com/industrial/index.cfm?chemical=!EN!86!0&lang=DE; http://www.rotert-os.de/produkte/gesundheit/handschutz.htm

11) http://www.dguv.de/ifa/Praxishilfen/Schutzhandschuhe-gegen-chemische-und-biologische-Einwirkungen/Kennzeichnung-und-Normung/index.jsp

12) Integrated prevention and reduction of environmental pollution fact sheet on the best available technologies for the surface treatment of metals and plastics, September 2005, with selected chapters in German translation

13) Hazard assessment

14) Assignment table for companies that provided the hazardous substance measurements

15) http://www.gesetze-im-internet.de/bundesrecht/abwv/gesamt.pd

16) http://www.bmub.bund.de/fileadmin/bmu-import/files/pdfs/allgemein/application/pdf/taluft.pdf

17) Seidler study

18) http://epaper.industriemagazin-verlag.at/11718/Factory_0614,7.html

19) Information table Gravemeyer 2008–2010

20) Information table Gravemeyer 2011–2012

21) http://www.baua.de/de/Publikationen/Fachbeitraege/Suga-2012.html;jsessionid=F70CF2783819413A0F5D9F08D87326B4.1_cid353

22) Attached file ‘2015-02-13 Chromate calculations report’

23) (Operating instructions)

24) Kauermann study on MEGA data, in preparation

25) http://www.baua.de/de/Themen-von-A-Z/Gefahrstoffe/TRGS/pdf/910/910-Chrom-VI.pdf?__blob=publicationFile&v=2, justification for TRGS 910

26) Pesch, B.; Weiss, T.; Pallapies, D.; Schlüter, G.; Brüning, T. Letter to the editor. Re.: Seidler, A.; Jähnichen, S.; Hegewald, J.; Fishta, A.; Krug, O.; Rüter L.; Strik, C.; Hallier, E.; Straube, S.: Systematic review and quantification of respiratory cancer risk for occupational exposure to hexavalent chromium, Int Arch Occup Environ Health (2013), in press. DOI 10.1007/s00420-013-0887-4

http://www.baua.de/de/Themen-von-A-Z/Gefahrstoffe/TRGS/pdf/910/910-Chrom-VI.pdf?__blob=publicationFile&v=2

http://www.baua.de/de/Themen-von-A-Z/Gefahrstoffe/TRGS/pdf/910/910-Chrom-VI.pdf?__blob=publicationFile&v=2

http://www.baua.de/de/Publikationen/Fachbeitraege/Suga-2012.html;jsessionid=F70CF2783819413A0F5D9F08D87326B4.1_cid353

http://www.baua.de/de/Publikationen/Fachbeitraege/Suga-2012.html;jsessionid=F70CF2783819413A0F5D9F08D87326B4.1_cid353

http://epaper.industriemagazin-verlag.at/11718/Factory_0614,7.html

http://www.bmub.bund.de/fileadmin/bmu-import/files/pdfs/allgemein/application/pdf/taluft.pdf

http://www.bmub.bund.de/fileadmin/bmu-import/files/pdfs/allgemein/application/pdf/taluft.pdf

http://www.gesetze-im-internet.de/bundesrecht/abwv/gesamt.pdf

http://www.dguv.de/ifa/Praxishilfen/Schutzhandschuhe-gegen-chemische-und-biologische-Einwirkungen/Kennzeichnung-und-Normung/index.jsp

http://www.dguv.de/ifa/Praxishilfen/Schutzhandschuhe-gegen-chemische-und-biologische-Einwirkungen/Kennzeichnung-und-Normung/index.jsp

http://www.rotert-os.de/produkte/gesundheit/handschutz.htm

http://www.anselleurope.com/industrial/index.cfm?chemical=!EN!86!0&lang=DE

http://www.euro.who.int/__data/assets/pdf_file/0005/74732/E71922.pdf

http://www.baua.de/de/Publikationen/Fachbeitraege/Suga-2010.pdf?__blob=publicationFile&v=7

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1007816/pdf/brjindmed00156-0034.pdf

http://www.oecd.org/env/tools-evaluation/49453368.pdf

http://www.oecd.org/env/tools-evaluation/49453368.pdf



27) Birk, T., Mundt, K.A., Dell, L.D., Luippold, R.S., Miksche, L., Steinmann-Steiner-Haldenstaett, W., Mundt, D.J.: Lung cancer mortality in the German chromate industry, 1958 to 1998. J. Occup. Environ. Med. 48 (2006a) 426-433

28) V. Handke, C. Kamburow, ‘Umweltstandards für thermische Solarkollektoren unter besonderer Berücksichtigung der selektiven beschichtung ihrer Absorberoberflächen’ [Environmental standards for thermal solar collectors taking into account the selective coating of their absorber surfaces], Institut für Zukunftsstudien und Technologiebewertung [Institute for Futures Studies and Technology Assessment ], Werkstattbericht Nr. 97, ISBN 978-3-929173-97-0, Berlin, June 2009

29) ‘A Review of Human Carcinogens. C. Metals, Arsenic, Fibres and Dusts — Part Nickel and Nickelcompounds’, IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Volume 100 (C); International Agency for Research on Cancer (IARC), 2012



6 Formulation of the full application for authorisation

for the

Use of chromium trioxide in dissolved and solid form to produce

aqueous solutions of any composition for industrial application with a

maximum risk level of 4:10 000

The present application shows the lack of alternatives for this use. In addition it shows the

possibility of reliably and reasonably keeping the risk of using the SVHC, chromium trioxide, at a

very low level in accordance with the above definition of use. In addition, in its socio-economic

analysis, the application shows that the benefits of the use scenario for the European

community outweigh the statistically expected economic expenditure from the welfare costs

resulting from the risk of illness.

The application is aimed at the approval of technical implementations that take into account the

above use, that fall under a specific risk limit — the statistical first case limit defined in the

application — and that demonstrate regular monitoring of key parameters.

Authorisation is requested for companies with no more than 2 000 regularly exposed workers,

with a term of 25 years until the next review. The statistical first case limit in this case is

50 years, more than double the requested term. In real companies the exposure is significantly

lower, as has been shown.

chemical safety report (based on sections 9 and 10)

Documents