Application for granting an authorisation in accordance

Socio-Economic Analysis

SEA 4.2:10 000 HAPOC GmbH & Co. KG 1

Application for granting an authorisation in accordance with the REACH Regulation

for the

use of chromium trioxide in solid form and in aqueous solution of any composition to modify the

properties of surfaces made of brass, bronze, copper and other copper alloys for medical engineering,

aviation and automation products, at a maximum risk level of 4.2:10 000.

The present application shows the lack of alternatives for this use that are technically and economically

feasible. 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 European

society 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 50 regularly exposed workers, with a term

of 30 years until the next review. The statistical first case limit in this case is 1 900 years, more than

60 times the requested term.



Socio-Economic Analysis 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 solid form and in aqueous

solution of any composition to modify the properties of

surfaces made of brass, bronze, copper and other copper

alloys for medical engineering, aviation and automation

products at a maximum risk level of 4.2:10 000.

Use number: 6



Contents APPLICATION FOR GRANTING AN AUTHORISATION IN ACCORDANCE WITH THE REACH REGULATION ................................ 1 BASIS OF THE PERFORMED ANALYSIS FOR AUTHORISATION IN CSR, AOA AND SEA ............................................................ 4 CONTEXT OF THE FULL APPLICATION ................................................................................................................................. 5 SUMMARY OF THE SEA ...................................................................................................................................................... 9 1 OBJECTIVE AND SCOPE OF THE SOCIO-ECONOMIC ANALYSIS ................................................................................ 10

1.1 DEFINITION OF THE ‘APPLIED FOR USE’ SCENARIO (USE SCENARIO) .................................................................................................... 10 1.2 DEFINITION OF THE ‘NON-USE’ SCENARIO (PROHIBITED SCENARIO) ................................................................................................... 11

2 IMPACT ANALYSIS ................................................................................................................................................ 12 2.1 IMPACT ON HUMAN HEALTH AND THE ENVIRONMENT ....................................................................................................................... 12

2.1.1 Analysis based on the air-quality guidelines of WHO ........................................................................................................... 12 2.1.2 Illustrative study on risk minimisation measures .................................................................................................................. 13 2.1.3 Analysis based on the ʻdose-response relationshipʼ2) .......................................................................................................... 13

2.1.3.1 Discussion of the welfare costs for the incidence of illness ................................................................................................... 16 2.1.3.2 Illustrative representation of the absolute risk level ............................................................................................................. 16

2.2 ECONOMIC IMPACT .............................................................................................................................................................................. 18 2.2.1 Qualitative discussion of the socio-economic loss of the non-use scenario .......................................................................... 18 2.2.2 Illustrative quantitative estimation of the socio-economic benefit of the use scenario ........................................................ 20

2.2.2.1 Socio-economic benefit from the turnover – continuity of the company and securing the livelihood of the workers – sample calculation ................................................................................................................................................................................ 20 2.2.2.2 Socio-economic benefit from profit – contribution to the community ................................................................................. 21 2.2.2.3 Socio-economic benefit from the ‘added value’ from surface coating — inclusion in value-added chains .......................... 21 2.2.2.4 summary of the illustrative calculation ................................................................................................................................. 23 2.2.2.5 Explanations of the scenario analyses based on the dose categories with a maximum risk level of 4.2:10 000 ................... 23

Scenario 1: Socio-economic analysis of the maximum risk level of 2.4:10 000 ....................................................................... 24 Explanations on the data in the tables of the scenario analysis: ............................................................................................. 28

2.3 SOCIAL CONSEQUENCES ....................................................................................................................................................................... 30 2.4 EXTENDED ECONOMIC CONSEQUENCES ............................................................................................................................................... 32

3 CONSOLIDATING THE EXPECTED CONSEQUENCES ..................................................................................................... 33 3.1 COMPARISON OF THE IMPACT .............................................................................................................................................................. 33 3.2 ANALYSING THE UNCERTAINTY OF THE RESULT ................................................................................................................................... 35

4. CONCLUSIONS AND APPLICATION ............................................................................................................................. 35 4.1 CONCLUSIONS ....................................................................................................................................................................................... 35 4.2 APPLICATION ......................................................................................................................................................................................... 36

5. REFERENCES ............................................................................................................................................................. 37



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

1. The analysis performed for the application for authorisation refers specifically to the applications

needed to manufacture chromated brass, bronze, copper and other copper alloys. These

components are used in medical engineering, aviation and automation equipment. The use of

chromium trioxide for this application should be authorised.

2. The present application predominately uses official data, measurements and assessment criteria

(e.g. dose-response relationship) and their recommendations and guidelines. Using these

specifications, the real observable risk from using the SVHC in the individual company is

determined. This is the basis for evaluating the indirect costs from the use scenario.

3. For the socio-economic assessment, both operating parameters and parameters in the supply chain

are used.

4. The applicant commits itself and the companies supplied by the applicant, regularly to document

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

This relates first, of course, to the risk level that must be adhered to and the minimum socio-

economic requirements. It is also obligatory continuously to document the active development of

measures for further minimising the risk and the 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 the

use of chromium trioxide in solid form and in aqueous solution of any composition to modify the


aviation and automation products at a maximum risk level of 4.2:10 000.

The applicant defines conditions that a downstream user must fulfil in order to make use of the present

authorisation and to be supplied on this basis.

The applicant defines conditions that a downstream user must fulfil in order to make use of the present

authorisation and to be supplied on this basis. The applicant places particular value on a level playing

field. Furthermore, it wishes to provide documented evidence itself that the downstream users comply

with the framework conditions required for the authorisation. There should not be sole reliance on

national implementation.

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

1. Presentation of the standard technical equipment of the downstream user companies assessed

that carry out the use on their site. It also contains a description of the contributing exposure

scenarios and the risk minimisation measures. It also 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 numbers of official cases (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:

- In recent decades, the technical equipment of companies has changed a great deal because of

automation and risk management; modified company organisation has resulted in a great

reduction in the routine exposure period of workers;

- There are real measurements that show the low exposure concentrations;

- All three of the above ways of describing risk yield comparable quantitative levels of risk

depending on the dose.



- To compare different risk scenarios quantitatively, the term ‘statistical first case limit’ was

introduced; it describes the maximum number of exposed workers, which in 50 years of

operation, has not yet resulted in a statistically expected first case of illness in the company.

- the statistical first case limit in the present case of a maximum risk of 4.2:10 000 is at least 1 900;

i.e. only at a number of more than 1 900 exposed workers would a first case of illness be

statistically expected within 50 years of operation;

- As downstream users of the requested use are SMEs, this statistical first case limit is often far

above the reality; there are usually up to 20 exposed workers. As a logical consequence, it must

be assumed under the given conditions that no case of illness must be expected in more than

4 500 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.

When assessing other (parallel) technologies as alternatives to the requested use, the following was

found:

- The use of the aqueous solution of chromium trioxide for transparent chromium plating is a

technology that has been used for a long time. As a result of extensive experience, its use is

closely linked to the function of the finished product of an anaesthetic evaporator (Vapor) of the

client companies and therefore the finished product itself.

- The use of colourless chromium plating is a key part of the overall VAPOR product of the client

companies.

The first Vapor launched on the market was produced in 1960. This copper pot Vapor had, as the

name suggests, a copper pot, which was responsible for conducting heat to prevent the anaesthetic

cooling down, and to ensure the correct dose. This pot was the first part that was chromium plated

without colour.

The finished housing part in the evaporators is a fixed component of the dosing unit.

- Alternatives were tested and, as a result of inadequate adhesion, pickling properties (cleaning)

and corrosion properties, were found to be unsuitable.

The experiences of parallel technologies are well documented, as these have been used for a long

time (20–30 years) and have secured their market share. They have grown according to the market



requirements and the requested functions, but cannot achieve the requirements requested in this

case.

- The risk potential of the use itself is negligible compared with the increased risk potential to

patients.

- In principle, a parallel technology should only therefore be considered in the field of medical

engineering if this technology can adequately reproduce the properties required by the user (at

least 98% of the levels achieved by the chromium coating is considered plausible), both in terms

of physical attainability and the physical values. This is also influenced by the economic

constraints of the finished product VAPOR.

- Overall it should be stressed that the available information on the parallel technologies being

discussed does not permit a transparent and clear assessment in all matters. In the majority of

cases, replacement with parallel technologies would be high risk in terms of actual feasibility.

The core findings of the socio-economic analysis (SEA) are expressed in the following:

- The requested use is used by specialised companies that perform a small step in a large supply

chain;

- As the analysis of alternatives does not yield any comprehensive alternatives, the non-use

scenario would be synonymous with the loss of the company in its previous form; this scenario

is therefore particularly likely as the finished products without the chromium trioxide-based

surface technology cannot achieve the necessary safety for the lives of patients.

- The socio-economic disadvantages of the non-use scenario for society consist of three

components:

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

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

the whole community (time limited);

o loss of ‘added value’ to the finished medical products in their form to date = decreased

added value of the finished products (permanent);

- the welfare costs of the use scenario were calculated based on the ECHA-defined dose-

response relationship; 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 4.2:10 000 assumed in this application gives a ratio of at least 1:1 900

of welfare costs to socio-economic benefit. The annual welfare costs per worker do not exceed

the value of EUR 15.75/year even in the most unfavourable conditions;



- 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 SEA

For a simpler overview of the following explanations, the core findings of the analysis are

summarised at the start:

- As the analysis of alternatives does not yield any technically and economically feasible

alternatives for the affected companies, the non-use scenario would be synonymous with the

loss of the company in its previous form.

- the estimations of the socio-economic disadvantages of the non-use scenario for the

community are based on the most favourable, i.e. lowest still plausible monetary losses for the

community;

- 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 whole community

(time limited);

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

the whole community (time limited);

o loss of ‘added value’ to the value-added chain in its form to date = decreased added

value of the finished products (permanent).

- the welfare costs of the use 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 level could not be made plausible and therefore had

to be set lower.

- the maximum risk level of 4.2:10 000 assumed in this application gives a ratio of at least

1:1 900 of welfare costs to socio-economic benefit.

The annual welfare costs per worker do not exceed the value of EUR 15.75/year even in the

most unfavourable conditions;

- 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.



1 Objective and scope of the Socio-Economic Analysis

1.1 Definition of the ‘applied for use’ scenario (use scenario)

The use scenario means an unmodified use of chromium trioxide and its aqueous solutions as is the

case to date according to the requested use. In doing so, consideration must be given to applying the

risk minimisation measures taken from the CSR as a minimum measure. Representative of the required

risk minimisation are the exposure and dose levels measured on site, which are considered maximum

levels. The exposure levels still need to be reported on a regular basis and recently also the ingested

dose by the company and authorities.

Use scenario: Use of chromium trioxide in solid form and in aqueous solution of any composition to modify the


aviation and automation products at a maximum risk level of 4.2:10 000.

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

the definitions that 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.

This use scenario (ʻapplied-useʼ scenario) includes the use of chromium trioxide to clean and pretreat

the surfaces of specialist medical devices. It relates to an anaesthetic evaporator made of brass or

bronze or other copper alloys. The surface treatment is – as will be shown – a requirement for the

quality-assured manufacture and permanently reliable function to avoid dosage deviations and therefore

incalculable risks for the health of patients.



Examples of these devices are the Vapor 2000 and the Vapor 3000. A Vapor is an unheated,

calibrated anaesthetic evaporator to enrich dry, medical fresh gases of an anaesthetic workstation

with a precisely dosed concentration of the vapour of a volatile anaesthetic. Vapor 2000 and Vapor

3000 are intended for use in anaesthetic workstations in hospitals and premises used for medical

purposes.

Vapor 2000 is suitable for operation on ships, taking into account specific handling instructions.

Vapor 2000 is suitable for use in the vicinity of strong magnetic fields (MRI scanners). Vapor 2000 is

suitable as a result of its material composition!

For these applications, the use scenario means that chromium trioxide may continue to be used beyond

the sunset date, to modify the surface properties of medical equipment made from copper alloys such

as brass or bronze with the requirements specified in the AoA and without any detriment to quality.

1.2 Definition of the ‘non-use’ scenario (prohibited scenario)

The non-use scenario means the

complete non-use of chromium trioxide in solid form and in aqueous solution of any composition to

modify the properties of surfaces made of brass, bronze, copper and other copper alloys for medical

engineering, aviation and automation products, at a maximum risk level of 4.2:10 000.

The reason for this ultimate non-use scenario is primarily found in the fact that the involved companies

have been optimising and coordinating their products and services for years. While equipment

manufacturers create the optimum mechanical and flow requirements for the optimum, maximum

protection for patients, the downstream user that uses the requested use provides support with the best-

possible surface properties. The former is primarily achieved through material selection (copper alloys

such as brass or bronze) and the design, the latter by the specific surface treatment in accordance with

the requested use. As the AoA has shown, the use of varying surface technologies on the used

materials leads to incalculable risks to patients in that the properties may result in disadvantageous

consequences with long-term use in anaesthesia.

In particular, the following restrictions are therefore associated with the non-use scenario:

1. loss of the technical use of chromium trioxide-based surface engineering to ensure the

optimum, stable properties of anaesthetic evaporators;

2. reduction in the long-term suitability of anaesthetic evaporators for permanent medical use,

therefore either a reduction in the market share of copper alloy-based equipment; therefore



either reduced market share of the components or relocation of manufacture to countries

outside of Europe;

3. incalculable risks for anaesthetic patients as a result of a reduction in the long-term stability

and reliability of the anaesthetic evaporators.

Consequently the non-use scenario would mean that the livelihood of the assessed supply chain

would be lost, which currently has a significant global market share.

As the analysis of alternatives has shown that no fundamentally alternative substances

or technologies can be used for the service of surface modification of plastics by chromium trioxide and

its aqueous solution for the applications defined in this application, it is assumed that for the components

that need surface modification, either solutions of diminished performance (efficiency, quality,

downtime, component reliability, economy etc.) need to be accepted for socio-economic reasons, or the

manufacture of these components needs to be dispensed with altogether. For the companies addressed

in this document, these options are not possible. The European Community would need to consider

company closures as a result of the non-use scenario and hope that other, inferior solutions (not

‘alternatives’ as they cannot replace the full extent of the provision!) provide scant replacement – the

consequences would be difficult to estimate – in particular there would be an increased risk to patients

of their physical integrity.

2 Impact analysis

2.1 Impact on human health and the environment

The Chemical Safety Report (CSR) of this application has shown that only discharge to the environment

from the operating sites that are employing the requested use needs to be taken into account because

the substance does not remain on the treated parts.

The study has shown that the adverse effect on the environment can be ignored by adhering to the

applicable maximum emission values (see CSR of this application). For this reason, the following

assessment is restricted to the impact on people in the workplace.

2.1.1 Analysis based on the air-quality guidelines of WHO The Air Quality Guidelines (AQG) of the WHO2) in section 6.4 give a detailed risk assessment as a

result of Cr(VI) exposure. On page 140, for example, data from Norway is presented in detail, which is

based on an average workplace concentration of 100 µg/m³ (equating to an average lifetime exposure

of 6.9 µg/m³). A comparison group from the same companies was not subjected to chromium VI

exposure (i.e. working hours exposure = 0) and showed a lung cancer risk that was reduced by a factor



of 8.5. It is generally assumed that the lifetime dose and the risk of illness are linearly related11), whereby

the maximum dose for the control group may have been 6.9 µg/m³/8.5 = 0.81

µg/m³ (to be precise we would have to refer to an equivalent ‘dose’ because the risk factor for the

control group that could trigger an illness cannot be distinguished). If you compare the determined risk

of illness in Norway with the workplace level long accepted as being harmless by the Employers’

Liability Insurance Associations in Germany (at least below this value no further risk minimisation

measures were required and no further verification measurements taken) of 5 µg/m³ (equating to an

average lifetime exposure of 0.63 µg/m³ for workers with more than 40 years of work1), then the risk

of the worker developing an illness for all companies with a concentration of < 5 µg/m³ is in the range

of the control group from Norway (0.63 µg/m³ corresponds to the ‘Norwegian’ 0.81

µg/m³). Accordingly, we cannot assume an increased risk of developing an illness. On the contrary, the

observed risk level (including additional risk contribution!) corresponds to the general risk of illness of

the general population, as was determined in the study for Norway.

2.1.2 Illustrative study on risk minimisation measures Several studies on the dose-response relationships have been carried out in the past few decades. In

an early study by Sorahan et. al from 1987,5) the authors also discussed in detail the impact of official

limit values and subsequently improved plant structures. The data material is evaluated right at the

start. It is noted that already in the early 1970s, by introducing a TLV (threshold limit value) of

0.05 mg/m³ (50 µg/m³!!) and subsequently improving conditions in companies, no chrome ulcers or

asthma were reported. In particular, the implicitness of exhaust ventilation over baths was mentioned.

This relates to minimum standards that are recognised across Europe and are no longer questioned.

This result supports the statement also contained in this application that with modern standards and

exposure levels below 50 µg/m³ (in Germany even below 5 µg/m³) no tangible increased risk of illness

can be established in companies (see CSR).

2.1.3 Analysis based on the ʻdose-response relationshipʼ2) The operational risk has already been presented in detail in the CSR. In the following, the monetised

value of the risk of the ̒ use scenarioʼ should be established for affected companies: The dose-response

relationship according to2) defines the following correlation:

1 Calculation: 5 µg/m³ x 240 work days/365 days x 40 years of work/70 years of life x 8 h/24 h = 0.63 µg/m³



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

Excess lifetime (up to age 89) lung cancer risk estimates for workers exposed at different 8h-TWA concentrations of Cr(VI) for 40 years

In the CSR, dose categories are derived from this relationship that report the risk for various exposure

situations and exposure periods:

Definition of categories for companies of different dose situations (in each case the maximum assessment interval is used to calculate the probability coefficients); basis = requirements of the dose-response relationship: 40 years, 8 h/d, 5 d/week) similar presentation to …..

Dose categories (maximum risks)

Duration of exposure

a b c

Level of exposure

(as chromium trioxide)

< 0.5 h 0.5–2 h 2–8 h

A <= 0.42 µg/m³ < 0.000105 <= 0.00042 <= 0.00168

B 0.42–1.0 µg/m³ ≤ 0.00025 ≤ 0.001 ≤ 0.004

The highlighted dose categories are crucial to the present application and will be analysed in more

detail in the following:



Using the respective base risk, the corporate risk can be expressed in monetary units. The following

table reports the derived annual statistical probabilities for the relevant categories:

Annual probability of occurrence (= probability of triggering lung cancer) and ‘statistical first case limit’ of a new case of lung cancer depending on the dose category calculation: (duration of exposure (h)/8 h)* exposure level (µg/m³) * 4 : 1 000 : 40 years

category

Max. exposure duration (h/d)

Max. exposure level (µg/m³)

Probability per year per worker

statistical first case limit > 50 years at ...

Aa 0.5 0.42 0.00000263 > 7694 exposed workers

Ab 2 0.42 0.0000105 > 1904 exposed workers

Ba 0.5 1.0 0.00000625 > 3200 exposed workers

Statistical first case limit = the maximum number of exposed workers, which in 50 years of

operation, has not yet resulted in a statistically expected first case of illness in the company

In accordance with the presentation of the German BAuA3) we use a value of approx. EUR 1.5

million as a base level, which produces the following monetised risk levels per year:

Annual probability of occurrence (= probability of triggering lung cancer) and annual welfare costs depending on the dose category

category Max. exposure duration (h/d)

Max. exposure level (µg/m³)

Probability per year per worker

Annual statistical welfare costs per exposed worker (€)

Aa 0.5 0.42 0.00000263 3.94

Ab 2 0.42 0.0000105 15.75

Ba 0.5 1.0 0.00000625 9.38

calculation formula of the last column: (0.004 * (exp. level in µg/m³/1µg/m³) * (max. exp. duration in

h/8h) * EUR 1 500 000) / 40 years



2.1.3.1 Discussion of the welfare costs for the incidence of illness

Even if the value of EUR 1.5 million was accepted as a basis for monetisation, it is worth considering

the plausibility. This is particularly with a view to considering whether higher levels could be assumed

in certain circumstances.

For 2012 in 6) the number of new cases of lung cancer expected in the then 27 EU Member States

was estimated to be approx. 300 000 (this figure appears plausible because Germany alone has

approx. 50 000 new cases a year12) adjusted to the population, the value for Europe of six times that

of Germany is easily explained). This estimate may also apply today as a good assumption of the

annual number of new cases of illness.

At an assumed cost factor of EUR 1 500 000 per case, an overall expenditure can therefore be

calculated for the then 27 EU Member States of EUR 450 000 000 000 (EUR 450 billion). According

to 7) , in 2013 the gross domestic product of the EU was about EUR 16 000 billion. Consequently,

according to these details, about 2.8% of the gross domestic product of the EU would solely be used

for the welfare costs of the new cases of lung cancer occurring annually. This high proportion can be

legitimately questioned. Even higher assumptions in each case are implausible.

2.1.3.2 Illustrative representation of the absolute risk level

The absolute risk level resulting from the dose-response relationship (DSR) can be illustrated as

follows:

If you assume 5 µg/m³ as the maximum level of exposure that, according to previous handling, all

companies need to stay below (otherwise their type approval with no risk minimisation measures would

be called into question, at least in Germany), then the ELCR (exceeded life cancer risk) is 0.02.

Therefore, in accordance with the dose-response relationship, of 1 000 workers over the course of

89 years of life, statistically about 20 workers develop an illness. This value can be converted for easier

assessment. Per worker in the company, 0.02/40 = 0.0005 = 4:8 000 cases of lung cancer will

(statistically) develop annually. The risk of a new case of lung cancer for the general population is

12:19 200 = 4:6 400 (derived in the CSR of this application). This scenario (≤ 5 µg/m³), however, based

on the real measurements that were referenced in the CSR, is no longer encountered in current

companies that undertake the prescribed risk minimisation measures.



The risk assessment that is strictly related to individual companies can therefore be justified because

1. the individual operational risks are independent of other, even similar companies and

2. only a company employing the use can evaluate and influence its own risk situation.

In a standard company as considered in this application, there are no more than 20 workers that are

employed in exposure locations. Several companies have fewer than five regularly exposed workers.

Companies with long-standing surface-finishing operations sometimes have just single workers.

Assuming 20 full-time exposed workers gives an annual statistical number of 0.01 cases of lung cancer.

In other words, this type of company would statistically operate for 1/0.01 = 100 years before a first case

of lung cancer was triggered. Companies with fewer workers and lower exposure levels have

correspondingly lower risks (see the CSR for further examples!). If higher illness rates are observed,

the reasons are to be found in companies with elevated exposure, which ought to have been rectified

or prevented by supervisory authorities — these kinds of breaches of the rules that were applicable in

the past are not intended to be the subject of this application! Otherwise, additional risk factors (e.g.

smoking) shall be assumed to have a particular impact. This may also include a disregard for hygiene,

which workers would need to observe on the grounds of occupational health and safety requirements.

This correlation makes the low ‘welfare costs’ determined in the companies being considered plausible

and evident and clearly shows that the risk from chromium trioxide in a company using chromium

trioxide-based solutions to modify plastic surfaces that is managed correctly and is aware of its

responsibility to implement the risk minimisation measures that have been explained in the CSR could

be further reduced. This can be objectively assessed by the assumed dose categories (see CSR).

Overall, it should be noted that even a complete ban on chromium trioxide in surface engineering can

have no measurable effect at the current exposure levels because only individual cases are known at

present whose causes potentially lie in locally elevated dose intakes, which should have been prevented

by the authorities. For this reason, a complete ban (non-use scenario) is not considered to be conducive

to achieving the objective especially as the consequences would be economically significant (see

below). A partial approval that specifies individual uses and companies would — as was previously the

case — not be able to reliably prevent the occurrence of individual cases until such time that elevated

dose intakes are prevented by strict official measures.

The risk from the SVHC chromium trioxide is, as operational practice highlights, evidently at the

previously standard maximum accepted concentration of

5 µg/m³ lowered to an observable limit. The companies considered here fall below this exposure level

by at least a factor of 10. And the risk level is further substantially reduced by organisational



developments in terms of the exposure period (see above table). Negative effects in everyday working

life will not be observed, which is confirmed by the annual reports on accidents and occupational illness

in Germany (see the CSR for this application).

2.2 Economic impact

2.2.1 Qualitative discussion of the socio-economic loss of the non-use scenario As already explained in the analysis of alternatives (AoA) and in the Chemical Safety Report (CSR),

the companies considered here correspond to the 1:1 type.

As a 1:1 provider, the surface finisher works specifically on the specifications of a certain product

group, in this case that of medical products. The naturally achievable surface properties and the effect

of the solution containing chromium trioxide on the surface (e.g. cleaning) are the basis of the service.

The 1:1 provider collaborates closely with customers, who formulate the requirements of their products

into precise specifications and therefore define the specific effect of the requested use for as flawless

as possible a function of their products. The surface finisher uses the solutions containing chromium

trioxide to fulfil the binding specifications of the

customers. Yet the downstream user keeps its business model flexible, to address new markets,

customers and requirements, and so it can react quickly.



Service-Dienstleister für Oberflächenbearbeitung

1:1 Typus = Einbindung in feste

Wertschöpfungsketten

Surface-finishing service provider

1:1 type = inclusion in fixed value-added chains

Behörden Authorities

direkte Einflüsse (Regularien, Verordnungen, etc.) direct influences (rules, regulations, etc.)

Wertschöpfung Added value

Lieferant des Lieferanten (z.B. M/I) supplier of the supplier (e.g. M/I)

Lieferant / Formulierer Supplier/formulator

Oberflächenbearbeiter Surface processor

direkter Kunde Direct customer

Kunde des Kunden Customer of the customer

Auftrag Order

Spezifikation Specification

Bedarf Requirement

indirekte Einflüsse (Lobbyismus) Indirect influences (lobbying)

NGOs NGOs

The diagram illustrates that manufacturing by a downstream user in the 1:1 case depends exclusively

on the usability of alternative substances or technologies for customers. However, as the analysis of

Illustration for involving a downstream user of the present application in supply chains and

markets



alternatives has shown, there is no possible substitution, which means that not issuing the authorisation

for the requested use would also mean discontinuing the equipment (copper alloy-based anaesthetic

evaporators). The downstream user would lose the surface treatment and the components would need

at a minimum to be manufactured outside of the EU or would be discontinued without replacement. The

latter case would be associated with a massive loss of turnover for the customers.

2.2.2 Illustrative quantitative estimation of the socio-economic benefit of the use scenario As already shown, the non-use scenario for chromium trioxide for the surface-finishing companies being

considered would lead to a loss of technology and thereby of the entire manufacturing, including the

manufacturing of unmachined parts. The following estimation assumes that the non-use scenario is

limited at least to the loss of orders and revenue.

In the following, we illustrate which components make up the socio-economic benefit of the use scenario.

The quantitative values are estimated without limiting the general validity, concentrating on German

values; at appropriate points in the estimation we have supplemented comparative values of other

European countries. Subsequently, scenarios were analysed using the various components (see below

table), which enable a more detailed assessment of the impact under different conditions.

It must be considered that the underlying 1:n service providers support diverse scenarios. Naturally,

clients, the order situation, turnover and production quantity are subject to considerable fluctuation in

terms of time.

2.2.2.1 Socio-economic benefit from the turnover – continuity of the company and securing the livelihood of the workers – sample calculation

The turnover of a company is the basis of its existence. The costs that arise in terms of production

consist essentially of material and energy costs, and personnel costs.

The turnover is used to generate all workers’ pay and consequently ensures jobs and the private and,

above all, familial livelihood of the workers. Without any turnover, there are no jobs and the general

public (= the European Community) would become responsible for ensuring subsistence. Every country

has its own solidarity mechanisms.

At this point an estimation should be made of what the socio-economic benefit is for jobs to be secured

by the use scenario.

Depending on the geographic location, type of company and sector, training, in-house responsibility,

shift practices and professional experience, the gross wages in Germany of the affected employees are

between EUR 8.50/h and EUR 20.00/h (to compare: the wages in England are between GBP 6.50 and

GBP 11.57, i.e. approx. EUR 9.00–16.00). Average working hours can be assumed to be 168 h per



month. For an assumed 13 monthly wages, this gives an amount of EUR 18 564 to EUR 43 680 per

year.

Other factors include (German regulations) the employers’ social security contributions, which take a

factor of 1.25 (in England 1.138), which means the full expenditure per worker can be estimated at

EUR 22 277 to EUR 52 416 per year. These amounts are used both for the daily support of the workers

and their families and also as a solidarity fee for pension contributions, unemployment benefit and the

health system; other components include private pensions and – not to be forgotten – private

consumption. All these amounts have an economic benefit to the European Community and would

cease completely in the event of the loss of a job.

The entire socio-economic contribution from the turnover therefore amounts to EUR 22 277 to

EUR 52 416 per worker per year.

2.2.2.2 Socio-economic benefit from profit – contribution to the community

The companies affected by a potential non-use scenario not only generate economically viable turnover,

but the aim of commercial activities is to achieve a surplus (profit). The purpose of this profit in each

case is specific to the company. However, all companies are obliged to pay tax; in Germany this

concerns business tax, corporation tax and several others, which would no longer be paid, at least for

a period of time in the event of the disappearance of a company. These taxes, in addition to property

tax, are the single most important source of income for local governments. For this reason, they should

be estimated quantitatively to evaluate the community’s loss of revenue as a result of their loss.

An example invoice from the CDU in Tübingen (10)) shows the fiscal burden being taxed at approx.

30%. This 30% is taken as a plausible average value in the following (minimum in England is approx.

20%).

Companies in the affected electroplating industry generally generate a turnover of between EUR 80 000

and EUR 200 000 per worker per year (see 4) page 5; the electroplating companies that process

chromium trioxide are at the upper limit of the turnover of the sector 25.61, which also includes other

surface-engineering technologies). Both the turnover and the profit margin depend on the economy and

cannot therefore be reliably estimated. In this case an average profit ratio of 4–6% before taxes should

be assumed (4), page 5, return on sales). The expected tax revenue is therefore calculated using the

30% assumed above to be EUR 2 832 to EUR 7 080 per year and per worker.

2.2.2.3 Socio-economic benefit from the ‘added value’ from surface coating — inclusion in value-added chains

For most technical devices, surface engineering is a pre-requisite for its long-term functionality,

longevity and the producibility of tools, parts, machines and everyday objects.



In the present case the proportion of affected companies in the value-added chain comes from the

surface treatment of medical anaesthetic evaporators using chromium trioxide-based solutions. Without

the relevant surface treatment, the components cannot be used. According to the AoA, there is no

alternative that can fulfil both the medically safe use and also protect patients. Consequently both work

steps are intrinsically linked. Regulatory measures affect both manufacturing sectors equally.

Qualitatively, the consequences can be described as follows:

Firstly, the lack of equivalent alternatives may result in large portions of the supply chains, including raw

part machining, being outsourced outside of the scope of REACH (i.e. to non-EU countries).

Secondly, we can assume that the current, chromium trioxide-based technologies could be replaced;

however, they would be replaced by lesser-quality or more expensive technologies. Otherwise they

would already be available on the market, would have been identified in the AoA, or they would have

technically and/or commercially displaced the established technology. However, above all the risk for

the health of the anaesthetised patients is incalculable; for as the analyses in the AoA have shown,

surfaces processed using other methods are quickly corroded, which would first be indirectly visible as

a result of the effect on patients. The resulting dose deviations quickly result in irreparable harm to

patients or to their premature awakening from anaesthesia – an experience that anyone would certainly

wish to avoid!

For safety purposes, the equipment would need to be removed from operation at regular and frequent

intervals, transferred to a lab and tested, and any necessary repairs carried out. It should be generally

assumed that both the qualitative deterioration and the increase in costs for testing etc. must be at least

5% – otherwise the technologies would already be on the market. This 5% can be justified, for example

by

- increased energy requirement

- increased raw material requirement

- higher reject rates

- lower service life

- greater expenditure on recycling and waste treatment

- requirement of highly qualified workers

- increased treatment times

- testing and repair costs

- and much more.

These amounts would always be estimated annually and are estimated quantitatively in the attached

table. The consequences of any harm to the health of patients was not estimated as this could only be



based on speculation – reliable estimations would only be possible following broad field trials. However,

the applicant assumes that a potential massive acute harm to humans should be unconditionally

excluded – otherwise REACH would result in an arbitrary exchange of risks. The explanations should

therefore be viewed as additional assessments that should not lead us to lose sight of the acute patient

risk.

2.2.2.4 summary of the illustrative calculation

The previous illustration resulted in three components of the socio-economic benefit of the ‘applied-

for use’ scenario or of the expected loss in the event of the ‘non-use’ scenario.

The contributions from the turnover and profit, compared with the amount from the ‘added value’, will

not be incurred on a permanent basis. It should be assumed that workers will take up new employment

within a standard time period and that this employment has the same monetary terms.

To estimate the total socio-economic benefit, an assumption needs to be made as to how long it would

take the former workers to take up new employment. Once again, highly heterogeneous geographic but

also person-specific influences take effect. It is generally easier to teach younger workers than older

workers; on the other hand the surface-coating profession is highly specialised and the available

positions correspondingly rare. Switching to another profession is generally associated with a reduction

in salary because of the lack of training.

An average 300 workdays of unemployment should be assumed.

We still need to determine the time period to which this amount needs to be allocated so that it can be

compared with the exposure over a person’s working life and be normalised to annual values. In the

absence of other data, an average remaining working life of 15 years is assumed.

More detailed calculations are possible using the enclosed table (see Annex). It is subject to the

following scenario analyses, which are based on the categorisation of companies in accordance with

the CSR, section 7.5 of this application. Additional informative data is listed in the enclosed calculation

table.

2.2.2.5 Explanations of the scenario analyses based on the dose categories with a maximum risk level of 4.2:10 000

The presented scenario explains the calculations based on the maximum risk level assumed in this

application of 4.2:10 000. Further calculation tables are enclosed in a separate file as an Annex. These

enable further scenario analyses to be performed:



Scenario 1: Socio-economic analysis of the maximum risk level of 2.4:10 000

1 Basic data for calculation Values 3 Application Category Ab

4

Exposure concentration (µg/m³) 0.42 5 Number of exposed workers (only for illustration)

5 6 Number of workers affected by the non-use scenario

25 7 Daily exposure period (h)

2 8 Mean proportion of the total value added to supply chains

5% 9 Social security factor

1.2 10 Return on sales

5.00% 11 Relative deterioration of non-use scenario

5.00% 12 Average business tax contribution

30% 13 Medical expenses for the community (per incident of

illness)

€1,500,000.00 14 Result from the calculations below:

15 Annual welfare costs per exposed worker

€15.75 16 Ratio socio-economic benefit : welfare costs (min.)

25,642 17 Ratio socio-economic benefit : welfare costs (max.)

53,025 18

19 Official data

20 Gross domestic product (GER) 2013 [€] exchange rate on

02.04.2015

3,357,768,000,000

https://en.wikipedia.org/wiki/List_of_countries_by_GDP_(nominal)




21 Gross domestic product (EU) 2013 [€] exchange rate on

02.04.2015

16,043,974,000,000 22 Medical expenses for the community (per incident of

illness)

1,500,000 23 Number of new cases of lung cancer, annual

(GER)

50,000 24 Welfare costs, annual (GER)

75,000,000,000 25 Proportion of GDP (GER)

2.23% 26 Number of new cases of lung cancer, over 40 years

(GER)

2,000,000 27 Welfare costs, over 40 years (GER)

3,000,000,000,000 28 Number of new cases of lung cancer,

annual (EU)

300,000 29 Welfare costs, annual (EU)

450,000,000,000 30 Proportion of GDP (EU)

2.80% 31 Number of new cases of lung cancer, over 40

years (EU)

12,000,000 32 Welfare costs, over 40 years (EU)

18,000,000,000,000 33 Risk assessment

34 Risk level according to the dose-response

relationship

0.00042 35 Additional risk of illness caused by

exposure/worker per year

1.05E-05 36 Additional risk of illness caused by exposure

per year in company

5.25E-05 37 Number of statistical new cases in 40

years

2.10E-03 38 Risk assessment for workers and

company

39 Welfare costs/worker and year





€15.75 40 Welfare costs of the company/year

78.75 41 Proportion of annual welfare costs (GER)

0.0000001050% 42 Proportion of annual welfare costs (EU)

0.0000000175% 43

44 Socio-economic assessment

45 Socio-economic benefit from turnover

46 Number of monthly wages

13 47 Min. hourly wage

€8.50 48 Max. hourly wage

€22.60 49 Mean hourly wage

€15.55 50 Mean number of hours worked per

month

168 51 Social security factor

120.0% 52 Min. annual cost of

labour = sum of socio-economic benefits from min. turnover

per year

EUR 22 276.80 53 Max. annual cost of

labour = sum of socio-economic benefits from max. turnover per year

€59,230.08 54 Socio-economic benefit from profit

55 Average company contributions (business tax etc.)

30.00% 56 Min. turnover per worker

€80,000.00 57 Max. turnover per worker

€165,000.00



58 Return on sales

5.00% 59 Min. annual contributions per worker

€1,200.00 60 Max. annual contributions per worker

€2,475.00 61 Annual socio-economic loss as a result of reduced total added value

62 Min. turnover per worker

€80,000.00 63 Max. turnover per worker

€165,000.00 64 Mean proportion of the total value added to supply chains

5.00% 65 Min. added value per worker in the supply chains

€1,600,000.00 66 Max. added value per worker in the supply chains

€3,300,000.00 67 Non-use scenario relative deterioration

5.00 % 68 annual socio-economic loss as a result of reduced total added value per worker

min

€80,000.00 69 annual socio-economic loss as a result of reduced total added value per worker

max

€165,000.00 70 Total socio-economic benefit from the use scenario

71 Average duration of unemployment (days)

300 72 Average duration of unemployment (years)

0.82 73 Remaining service life (years)

25 74 Minimum socio-economic annual contribution from turnover and profit

€771.84 75 Maximum socio-economic annual contribution from turnover and profit

€2,028.66



76 Min. annual socio-economic loss as a result of reduced total added value

€80,000.00 77 Max. annual socio-economic loss as a result of reduced total added value

€165,000.00 78 Minimum annual socio-economic benefits from the use scenario per worker

€80,771.84 79 Maximum annual socio-economic benefits from the use scenario per worker

€167,028.66 80 minimum annual socio-economic benefits from the use scenario

€2,019,296.00 81 maximum annual socio-economic benefits from the use scenario

€4,175,716.50 82 Average value per worker

€123,900.25 83 Factor of affected workers to exposed workers

5 84 Ratio socio-economic benefit : welfare costs (min.)

25,642 85 Ratio socio-economic benefit : welfare costs (max.)

53,025

Explanations on the data in the tables of the scenario analysis:

Row Explanation 4 Maximum exposure concentration that was assumed for the dose category

5 Number of exposed workers; this value is used for the scenario variation to generate absolute values; the

assessment criteria remain the results related to the workers to preserve comparability 6 Number of workers who would be affected by the non-use scenario, this relates both to surface

coaters and to their customers 7 maximum daily exposure period that was determined according to the dose categories defined in the CSR;

this selection ensures that the worse-case scenario is assessed in every category 8 Mean proportion of the overall value-added chain, i.e. which proportion of the total value of the surface-

finished components is omitted in the coating 9 Social security factor, i.e. how high the proportion of social security of the total labour costs is; 1.2 equates to a

proportion of 20 % 10 return on sales, i.e. surface engineering profit 11 Relative deterioration of the non-use scenario = minimum deterioration based on the fact that there is no 100%

alternative; fixed rate 12 Average business tax rate 13 Welfare costs per hypothetical illness; assumed value, the plausibility of which is discussed in detail in this text.



14-17 Results of calculations for the key assessment criteria: annual absolute welfare costs per worker, maximum

and minimum ratio of socio-economic benefit to welfare costs 20 Gross domestic product for Germany from 2013 21 Gross domestic product of the EU from 2013 22 Cost of illness to society (per case of illness), as was determined in the Socio-Economic Analysis. The value

comes from a public publication and was evaluated in the SEA as part of a plausibility assessment

(Section 2.1.3.1). 23 Mean number of new cases of lung cancer annually in Germany, as published by the national cancer registry of the

Robert Koch Institute 24 Total sum of the annual welfare costs based on new cases of lung cancer for the whole of Germany 25 Proportion of welfare costs based on new annual cases of lung cancer of the gross domestic product of Germany 26 Number of new cases of lung cancer in Germany, as published by the national cancer registry of the Robert

Koch Institute, over 40 years 27 Total sum of the welfare costs based on new cases of lung cancer for the whole of Germany, over 40 years 28 Average number of new cases of lung cancer annually in the EU6) 29 Total sum of the annual welfare costs based on new cases of lung cancer for the whole of the EU 30 Proportion of welfare costs based on new annual cases of lung cancer of the gross domestic product of the EU 31 Number of new cases of lung cancer in the EU over 40 years 32 Total sum of the welfare costs based on new cases of lung cancer for the whole of the EU, over 40 years 34 Risk level according to the dose-response relationship related to the assumed exposure level from row 4 35 Additional risk of triggering illness per year; equates to the value from the dose-response curve divided by the

assumed 40 years of work (see also the table in section 2.1.3) 36 Additional risk of triggering illness per year for a single case of illness in the company, based on the

number of exposed workers assumed in 5 37 Statistically expected value of new cases of lung cancer over 40 years 39 Result of welfare costs per worker and year 40 Total welfare cost of the company per year; equivalent to the product of 27 and 5 41 Proportion of annual company welfare costs of the entire welfare costs for Germany in the same period 42 Proportion of annual company welfare costs of the entire welfare costs for the EU in the same period 46 Assumed number of monthly wages per year paid at the standard wage 47 Minimum hourly wage 48 Assumed maximum hourly wage of workers in the affected companies 49 Mean value of the hourly wage from 35 and 36 50 Assumed mean number of hours worked per month 51 Factorised employer contribution to the social systems; multiplication of pay by this factor results in the

additional financial resources to be paid by the employer for the good of the general public 52 Minimum sum of the socio-economic benefit from turnover per year per worker 53 Maximum sum of the socio-economic benefit from turnover per year per worker 55 average company contributions (business tax etc.) in accordance with

http://bdi.eu/media/presse/publikationen/marketing10) 56 Minimum turnover per worker in accordance with the customer file of the Sparkasse

Finanzgruppe (Savings Bank Finance Group), surface finishing and heat treatment, industry

report, page 16

http://bdi.eu/media/presse/publikationen/marketing10)

http://bdi.eu/media/presse/publikationen/marketing10)



57

Maximum turnover per worker in accordance with the customer file of the Sparkasse

Finanzgruppe (Savings Bank Finance Group), surface finishing and heat treatment, industry

report, page 16

58 Return on sales in accordance with the customer file of the Sparkasse Finanzgruppe (Savings Bank

Finance Group), surface finishing and heat treatment, industry report, page 5 59 minimum charges of a company per worker 60 maximum charges of a company per worker 64 mean proportion of the total added value of the supply chains in accordance with the customer file of the

Sparkasse Finanzgruppe (Finance Group), surface finishing and heat treatment, industry report, page 16 65 minimum added value per worker in the supply chains 66 maximum added value per worker in the supply chains 67 Percentage reduction in added value as a result of the non-use scenario 68 Minimum annual socio-economic loss as a result of reduced total added value per worker = product 69 Maximum annual socio-economic loss as a result of reduced total added value per worker = product 71 Assumed average duration of unemployment (days) 72 Average duration of unemployment (years), alternatively calculated from 59

73

assumed remaining working life (years) per worker, to correctly allocate the consequences of the period of

unemployment; this factor has no influence on the loss of added value; the estimate takes into account the

information from 5) 74 Minimum socio-economic annual benefit of the use scenario from turnover and profit 75 Maximum socio-economic annual benefit of the use scenario from turnover and profit 76 Minimum annual socio-economic loss as a result of reduced total added value 77 Maximum annual socio-economic loss as a result of reduced total added value 78 Minimum annual socio-economic benefits from the use scenario per worker 79 Maximum annual socio-economic benefits from the use scenario per worker

80

Minimum annual socio-economic benefits from the use scenario (with regard to the exposed workers); the value

does not take into account any other workers who may be affected — therefore the value should be considered a

minimum value

81

Maximum annual socio-economic benefits from the use scenario (with regard to the exposed workers); the value

does not take into account any other workers who may be affected — therefore the value should be considered a

minimum value 82 Average value per worker, purely informational value 83 Ratio of number of affected workers to exposed workers; denominator 84 Minimum ratio of the socio-economic benefit of the use scenario to the general costs of the use scenario 85 Maximum ratio of the socio-economic benefit of the use scenario to the general costs of the use scenario

2.3 Social consequences

In 2.2 it was clear that the non-use scenario for the surface processing of the described anaesthetic

evaporator for the surface-treatment companies would mean, at least predominantly, the loss without

replacement of the associated manufacturing facilities. In the same vein, the associated jobs would be



superfluous. This would result in the customers of the surface engineering industry and/or the raw part

manufacturers moving to non-EU countries, for reasons of logistics and cost. This risk increases as the

affected medical equipment has a predominant, global market share. Should, therefore, the technology

of chromium trioxide-based surface finishing of components that is established and accepted in Europe

no longer be available, both the surface processing and the raw part manufacture would be a loss to

Europe's competitiveness.

Many of the affected employees are surface-engineering specialists and it would be difficult for them to

acquire equivalent occupations. The video in the following link shows how specialised the training is,

and a second video by Lufthansa Technik illustrates the significance and the demands – particularly

with regard to handling hazardous substances. Rejecting the approval would – as already explained –

inevitably result in plant closures. This then reduces the range of potential employers. A simultaneous

increase in the number of ‘specialised’ professionals (i.e. professionals limited to the surface

engineering industry) seeking work will lead to a reduction in the hourly wages in the medium term. For

economic reasons, the remaining employers can and will select those who are prepared to accept

(wage) concessions from a pool of specialist personnel.

In addition, it is highly likely that these few ‘remaining’ specialist positions will cause workers to relocate,

which takes them out of their usual personal and familial environment — to say nothing of the moving

costs or expenses for potentially having to run two households.

Long-term unemployment, which could be expected by many of those affected because of their greater

age, leads to depression and to the affected EU citizens losing their motivation and belief in an

independent future. Even if they are re-employed after a few years, their performance, from experience,

is permanently reduced.

Re-employment is generally associated with changing their geographic location, which means that the

entire family loses their social connection — personally, at school and also professionally. This difficult

social situation adversely affects the performance of all family members, which may lead to poor

performance at school and friction within the family. Psychosomatic illnesses are a frequently observed

consequence that has medium to long-term effects from a business and economic perspective.

For young people, the loss of the recently learnt and acquired profession is particularly demotivating

because they are torn away in the middle of their professional development. Understandably they

rapidly lose their belief in a future secured by a permanent job. In addition, the mass phenomenon of

youth unemployment is now unmanageable in many countries. To lose your own job in this situation

confirms the lack of confidence in the economic system of the EU. In addition to decreased motivation

to strengthen their social and professional position, those affected also lose confidence in the EU itself!

The consequences of widespread unemployment, particularly among young people, such as

aggression and hostility to the system as well as political disenchantment – the current

https://www.youtube.com/watch?v=RgBt__Xl9C4

https://www.youtube.com/watch?v=Y_z9sxuDw1w



demonstrations as part of the official opening of the new European Central Bank in Frankfurt am Main

(on 18.3.2015) send a clear signal. New cases can be following in the media daily.

In many EU countries a further, thoughtless handling of economic stability and security would be

irresponsible. There would have to be an extremely important and objective reason that could be

proved. Measures would have to objectively lead to clearly measurable results. Neither factor — as has

been shown in detail — exists for the present case of the non-use scenario for chromium trioxide.

2.4 Extended economic consequences

In the REACH process for authorisation there is an uncertainty in the decision-making process that is

inherent in the system as there is a lack of clear criteria for the Commission to make a decision, and

therefore a prediction. Affected companies therefore lose the confidence of their customers who can no

longer gauge the reliability of long-term business relationships. Order losses or a lack of orders could

already be observed once the substance was included in the candidate list, and this has intensified.

The Commission has established this itself in its report on REACH in 2012. By not granting the

authorisation, the last customers will turn away from EU companies to recover planning reliability at the

usual terms (technically and economically). This is made that much easier when the end products of chromium trioxide-based surface finishing can be imported into the EU without restriction! Studies have been carried out on this that clearly highlight this risk14).

Even now it can be observed that investment in surface treatment or subsequent processes that depend

on it, has been withheld8). Without authorisation or insufficiently approved technologies, this investment

will permanently fail to materialise. The further development of the anaesthetic evaporators would also

be affected.

REACH uncertainty and the lack of planning reliability makes the EU increasingly uninteresting for

foreign investors. The inflow of capital to the EU domestic market will therefore be reduced. Other

regions that are not affected by REACH will be able to successfully use this investment. It is precisely

the development, the acquisition of expertise and global distribution of high-quality medicinal products

that are of interest to all regions of the world.

The only reaction could be public investment — however, the permanent financial exchange internally

will not cause the domestic market to grow but will at best result in a reallocation. In the long term the

economy cannot benefit if its competitiveness and external appeal do not increase. This is even more

fatal, as it could be clearly shown that these likely consequences of a non-use scenario for chromium



trioxide would remain without any measurable positive impact on job security, the protection of the environment and consumer protection (see CSR)

3 Consolidating the expected consequences 3.1 Comparison of the impact

Consolidating 2.1 to 2.3 permits a good comparison between the overheads of the assumed risk and

the socio-economic benefit of the use scenario.

category Maximum factor

socio-economic

benefit/welfare costs

Minimum factor

socio-economic

benefit/welfare costs

Category Aa 212,100 102,567 Category Ab 53,025 25,642 Category Ba 89,082 43,078



The following diagrams illustrate the ratios:

maximaler Faktor sozioökonomischer Nutzen /

welfare costs

maximum factor socio-economic benefit/welfare

costs

Kategorie Aa Category Aa

Kategorie Ab Category Ab

Kategorie Ba Category Ba

It is evident that the socio-economic benefit far exceeds the value of the maximum assumed risk. The

factor is at least 25 000 times the value!

Evidently, even for the most unfavourable dose ratios assumed in this application, the socio-economic

benefit far exceeds the overheads.



3.2 Analysing the uncertainty of the result

In all areas of calculations, the most unfavourable ratios are assumed that are plausible for the applicant,

in particular:

- maximum exposure times in all dose categories,

- maximum exposure levels in all dose categories,

- maximum share in the supply chains’ added value, therefore lowest ‘leverage’,

- relatively high costs of individual illnesses (see section 2.1.3.1),

- etc.

Despite constantly focusing on the worst-case scenario, the socio-economic benefit of the use scenario

significantly outweighs the assumed overheads even under the most unfavourable dose category for

the use scenario.

4. Conclusions and application 4.1 Conclusions

The socio-economic benefit of the use scenario significantly exceeds the risk, which was expected

based on the low level of risk and the extensive workplace risk minimisation measures developed over

many years in the surfacing industry.

The explanations in the CSR show that the results of just a partial rejection of the requested use cannot

be measured because only individual cases of occupational illnesses can be assumed and observed.

A complete ban on the use, however, would be excessive because only a tiny fraction of the assumed

new cases of illness can be attributed to the use in electroplating (in Germany potentially 1–2 cases out

of a total of 50 000 a year!). In addition, it can be plausibly assumed that the observed cases are a result

of exposures and doses that are far above the doses specified in this application for companies and

which should not be permitted with strict official enforcement. In the Annex XV document13) on chromium

trioxide, measurements of 10–20 µg/m³ are referred to on page 21; these values are far above those

measured in actual companies. The values from the Annex XV document (2010, measurements from

years prior to 2006!) must be considered outdated and obsolete, particularly as they do not take into

consideration any change over time. The continued optimisation of the risk minimisation measures and

modified company organisation has now achieved significant reductions in exposure.



An authorisation should therefore be granted provided that continuous risk minimisation measures are

demonstrated that ensure the risk is managed to below a maximum threshold of 4.2:10 000.

4.2 Application

For the

Use of chromium trioxide in solid form and in aqueous solution of any composition to modify the properties

of surfaces made of brass, bronze, copper and other copper alloys for medical engineering, aviation and

automation products at a maximum risk level of 4.2:10 000.

in accordance with the following table

dose category

Statistical first case limit

> 50 years at more than ...

Number of exposed workers

less than ...

Ratio of the socio-economic benefit to

overheads

Annual statistical

welfare costs per exposed worker

(€)

category > 7,694 exposed workers 50 102 567–212 100 3.94

Aa

Category

Ab > 1,904 exposed workers 25 642–53 025 15.75

Category

Ba > 3200 exposed workers 43 078–89 082 9.38

Requested use for the authorisation of various dose categories and rounded ratio of the socio-economic benefit to overheads of the use scenario, indicating the annual welfare costs of the use scenario per worker

and the explanations of this application, we apply for authorisation with a review period of 30 years.

The reasons for this term can be summarised as follows:

- for a maximum of 50 exposed workers at the described level of exposure, an

illness will be triggered statistically only after more than 1 904 operating years;

consequently the term is just a sixtieth of the time until a statistically expected first case

of illness; thus the maximum risk is assumed to be 4.2:10 000, which in many cases is

far above the reality;



- as the analysis of alternatives has shown, there are no applicable alternatives for

the specified technology with the same or better scope of performance. The development

of alternative methods has not been widely successful in past decades. However, for as

long as there is no alternative on the market, customers need legal certainty.

- From the applicant's perspective, the extremely low risk levels justify a 25-year

review period, as otherwise the economic risk for the affected individual companies would

be disproportionate.

5. References

1) removed, as declared to be confidential 2) http://www.euro.who.int/data/assets/pdf_file/0005/74732/E71922.pdf 3) http://www.reach-clp-biozid-helpdesk.de/de/Veranstaltungen/pdf/2010/101025/101025-5-

Hutoran.pdf?__blob=publicationFile&v=2 4) Customer file of the Sparkasse Finanzgruppe 10/2014, surface finishing and heat

treatment, industry report 5) Age distribution analysis of ABAS workforces – a look to the future

(http://www.beschaeftigungsfaehigkeit-sichern.de/publikationen/externes_material/abas- broschuere.pdf) 2006

6) http://www.iarc.fr/en/media-centre/iarcnews/pdf/Ferlay%20J_EJC_2013.pdf, page 1382, Table 5

7) https://en.wikipedia.org/wiki/List_of_countries_by_GDP_(nominal) 8) http://www.sueddeutsche.de/wirtschaft/-milliarden-paket-wie-juncker-europas-wachstum-

foerdern-will-1.2237219 9) FERI EuroRating Services, industry rating for Germany, surface finishing and heat treatment,

2008 economic sectors No: 25.61, 1st quarter 2015 10) http://bdi.eu/media/presse/publikationen/marketing 11) RAC/27/2013/06 Rev.1 (Agreed at RAC-27), APPLICATION FOR AUTHORISATION:

ESTABLISHING A REFERENCE DOSE RESPONSE RELATIONSHIP FOR CARCINOGENICITY OF HEXAVALENT CHROMIUM, http://echa.europa.eu/documents/10162/13579/rac_carcinogenicity_dose_response_crvi_e n.pdf

12) http://www.krebsdaten.de/Krebs/DE/Content/Cancer_sites/Lung_cancer/lung_cancer_node.html

13) Proposal for Identification of a substance as a CMR CAT 1 or 2, PBT, vPvB or a substance on an equivalent level of concern, chromium trioxide, 2010

14) Enhancement of the REACH requirements for (imported) articles, Options for improvement of the chemicals regulation, Martin Führ, Julian Schenten, Andreas Hermann, Dirk Bunke, Umweltbundesamt (German Federal Environment Agency), 2015

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

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

http://www.reach-clp-biozid-helpdesk.de/de/Veranstaltungen/pdf/2010/101025/101025-5-Hutoran.pdf?__blob=publicationFile&v=2

http://www.reach-clp-biozid-helpdesk.de/de/Veranstaltungen/pdf/2010/101025/101025-5-Hutoran.pdf?__blob=publicationFile&v=2

http://www.beschaeftigungsfaehigkeit-sichern.de/publikationen/externes_material/abas-broschuere.pdf

http://www.beschaeftigungsfaehigkeit-sichern.de/publikationen/externes_material/abas-broschuere.pdf

http://www.iarc.fr/en/media-centre/iarcnews/pdf/Ferlay%20J_EJC_2013.pdf


http://www.sueddeutsche.de/wirtschaft/-milliarden-paket-wie-juncker-europas-wachstum-foerdern-will-1.2237219

http://www.sueddeutsche.de/wirtschaft/-milliarden-paket-wie-juncker-europas-wachstum-foerdern-will-1.2237219

http://bdi.eu/media/presse/publikationen/marketing

http://echa.europa.eu/documents/10162/13579/rac_carcinogenicity_dose_response_crvi_en.pdf

http://echa.europa.eu/documents/10162/13579/rac_carcinogenicity_dose_response_crvi_en.pdf

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



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