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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
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Formulation CSR Hapoc GmbH & Co. KG 2
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
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Formulation CSR Hapoc GmbH & Co. KG 3
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.
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Formulation CSR Hapoc GmbH & Co. KG 4
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.
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Formulation CSR Hapoc GmbH & Co. KG 5
- 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);
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Formulation CSR Hapoc GmbH & Co. KG 6
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.
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Formulation CSR Hapoc GmbH & Co. KG 7
Summary of the CSR
The present dossier requests authorisation for the use
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 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;
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Formulation CSR Hapoc GmbH & Co. KG 8
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.
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Formulation CSR Hapoc GmbH & Co. KG 9
1 Specification of the use for which authorisation is being requested
Authorisation is requested for the following use:
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
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.
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Formulation CSR Hapoc GmbH & Co. KG 10
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).
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Formulation CSR Hapoc GmbH & Co. KG 11
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.
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Formulation CSR Hapoc GmbH & Co. KG 12
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.
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Formulation CSR Hapoc GmbH & Co. KG 13
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:
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 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.
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Formulation CSR Hapoc GmbH & Co. KG 14
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.
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Formulation CSR Hapoc GmbH & Co. KG 15
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.
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Formulation CSR Hapoc GmbH & Co. KG 16
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.
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Formulation CSR Hapoc GmbH & Co. KG 17
Product characteristics
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.
Alternatively, the substance can also be used at a higher concentration (up to 750 g/l) as a
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.
Technical conditions and measures at a process level (source) to prevent releases
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.
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Formulation CSR Hapoc GmbH & Co. KG 18
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.
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Formulation CSR Hapoc GmbH & Co. KG 19
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
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Formulation CSR Hapoc GmbH & Co. KG 20
personal protective equipment is worn and local exhaust ventilation is used to reduce the
exposure potential.
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 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
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.
Other existing conditions of use that influence worker exposure
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.
Technical conditions and measures at a process level (source) to prevent releases
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.
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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, 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.
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.
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.
Frequency and duration of use/exposure
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.
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Other existing conditions of use that influence worker exposure
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.
Technical conditions and measures at a process level (source) to prevent releases
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.
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 monitored to ensure that the
exposure does not exceed acceptable levels and that the effectiveness of the protective
measures taken is sufficiently high.
Conditions and measures relating to personal protection, hygiene and health
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.
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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.
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• 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.
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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):
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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)
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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
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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.
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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.
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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
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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
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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.
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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.
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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
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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
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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
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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
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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
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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
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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.
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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.
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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).
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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
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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
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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.