impact assessment study into possible options for … · into possible options for adapting annex 1...

European Commission, DG ENV

Impact assessment study into possible options for adapting Annex 1 of the SEVESO II Directive into the GHS

Final Report

February 2010

European Commission, DG ENV

Impact assessment study into possible options for adapting Annex 1 of the SEVESO II Directive into the GHS

Final Report

February 2010

COWI A/S Parallelvej 2

DK-2800 Kongens Lyngby

Denmark Tel +45 45 97 22 11

Fax +45 45 97 22 12

www.cowi.com

Document no. 68535-G-Final_ report

Version 6

Date of issue1 09.04.2010

Prepared SOM, TSKY, MMS, FHHE

Checked MMS, SOM

Approved MMS

U:\LIH\COWI_Seveso II to GHS_impact assessment_final_09042010.doc .

Table of Contents

1 Executive summary 1

1.1 Health hazard 2

1.2 Physical hazards 10

1.3 Environmental hazards 11

1.4 Mixtures and solutions 11

1.5 Impacts of options 12

1.6 Overall assessment 14

2 Introduction 15

2.1 Background and objectives 16

3 Approach and input to the impact assessment 24

3.1 Approach to the impact assessment 24

3.2 Identification of impacts 25

3.3 Derogation rule and safety clause 28

3.4 Costs estimates related to Seveso II and to revisions of Annex 1 29

4 Impact assessment of translation of physical hazards 36

4.1 Overall assessment of physical hazards translation 36

4.2 Specific impact assessment of flammable aerosols 38

4.3 Other physical-chemical issues 47

5 Impact assessment of options related health hazards 49

5.1 Issues in translation of health hazards 49

5.2 Defining relevant alignment options 51

5.3 Impact assessment of health hazard options 64

5.4 Industry survey of relevant industries in France 90


6 Other hazards and issues in translation 95

6.1 Other hazards 95


6.3 Mixtures 96

7 Conclusions 100

7.1 Options by category 103

7.2 Physical hazards 107


7.4 Health hazard options 107

7.5 Impacts of overall adaption of Annex 1 112

Table of Appendices

Appendix A Questionnaire on substance for Member States

Appendix B Member State and industry survey: Overview of results

Appendix D Major accident potential assessment and scoring

Table of Figures

Figure 1-1 Illustration of difference between Seveso II health categories

and the CLP classifications ......................................................................... 3

Figure 1-2 Comparison of health hazard alignment options ..................... 6

Figure 1-2 Illustration of Option E and E* ............................................... 9

Figure 2-1 List of SEVESO establishments, based on SPIRS (as of

November 2009) ....................................................................................... 18

Figure 3-1 Analytical steps in assessment of alignment options ............ 24

Figure 5-1 Illustration of difference between Seveso II health categories

and the CLP classifications ....................................................................... 50

Figure 5-2 Overview of boundaries areas ............................................... 55

Figure 5-3 Impact Assessment Option A (IA Option A) ........................ 59

Figure 5-4 Impact Assessment Option B (IA Option B) ........................ 60

Figure 5-5 Impact Assessment Option C (IA Option C) ........................ 61

Figure 5-6 Impact Assessment Option D (IA Option D) ........................ 62

Figure 5-7 Comparison of health hazard alignment options ................... 62

Figure 5-2 Illustration of Option E and E* ............................................. 63

Figure 7-1 Comparison of health hazard alignment options ................. 109


Table of Tables

Table 1-1 Overview of alignment options for health hazards ......................... 5

Table 1-2 Overall assessment of health options .............................................. 7

Table 1-3 Overview of economic impacts (order of magnitude) - million

EUR per year ............................................................................................. 13

Table 3-1 Industry estimate of Seveso II costs (Estimates by FEA) ............. 32

Table 3-2 Overview of cost estimates in '000 EUR per year ........................ 34

Table 4-1 Initial assessment of alternatives for aerosols ............................... 40

Table 4-2 Suggested translation for aerosols ................................................. 41

Table 4-3 Description of FEA sample of establishments .............................. 42

Table 4-4 Impact of aerosol option ............................................................... 42

Table 4-5 Change in number of Seveso sites with option expressed as a

percentage ................................................................................................. 42

Table 4-6 Scaling of survey results for warehouses ...................................... 43

Table 4-7 Results of survey on French aerosol establishments ..................... 44

Table 4-8 Alternatives for pyrophoric solids ................................................. 47

Table 5-1 Number of critical substance in areas ........................................... 57

Table 5-2 Substance from Table 3.2 in Annex VI of 1272/2008 in area A5b

including Acute Toxic 3 (inhalation) ........................................................ 57

Table 5-3 Substance from Table 3.2 in Annex VI of 1272/2008 in area A8

including Acute Toxic 4 (inhalation) ........................................................ 58

Table 5-4 Overview of alignment options for health hazards ....................... 59

Table 5-5 Number of critical substance in areas ........................................... 65

Table 5-6 Important substances (candidates for named substances) ............. 66

Table 5-7 Impact of substances in areas A1 to A7 ........................................ 72

Table 5-8 Estimated impact on number of establishments ............................ 73

Table 5-9 Impact of substances in areas A1 to A7 ........................................ 73

Table 5-10 Estimated impact on number of establishments from named

substance scenario with 50% effect on scope reductions ......................... 74

Table 5-11 Estimated impact on number of establishments using 50 per

cent in scope due to health categories ....................................................... 74

Table 5-12 Estimated impact on number of establishments due to

increased effect on number of substances by a factor of 2 ....................... 75

Table 5-13 Estimated impact on number of establishments of the share of

T+ establishments with less than 50 tonnes up to 80 per cent .................. 75

Table 5-14 Estimated impact on number of establishments from all three

alternative assumptions combined ............................................................ 76

Table 5-15 Impact of options on number of establishments ................... 76

Table 5-16 Impact of options on number of establishments assuming that

a derogation rule and a safeguard clause are effective in maintaining scope

77

Table 5-17 Impact of options on number of establishments assuming that

named substance compensate 50% for a reduced area ............................. 77

Table 5-18 Overview of impacts of alternative alignment options - no

derogation rule/safety clause ..................................................................... 78

Table 5-19 Costs impacts of alternative alignment options .................... 81


Table 5-20 Sensitivity of the estimate of the costs of administrative

adaption - time requirement for applying differentiated exposure routes

and screening tool - € per year .................................................................. 82

Table 5-21 Sensitivity of the estimate of the costs of scope change in €

per year 83

Table 5-22 Sensitivity of the estimate of the costs of scope change

assuming the named substances can mitigate 50% of reduction in scope -

in € per year .............................................................................................. 83

Table 5-23 Sensitivity analysis: Estimate of cost impact assuming that

unit savings from reduced scope are only 20% of the unit costs from

increased scope - in € per year .................................................................. 84

Table 5-24 Major accident potential scoring of important substances by

area 89

Table 5-25 Impact of options measured as number of substances in on

major accident potential categories .......................................................... 89

Table 5-26 Description of industry survey .............................................. 92

Table 5-27 Use of identified substances .................................................. 93

Table 5-28 Impact of alternative options on number of establishments.. 93

Table 5-29 Impact of alternative options on number of establishments.. 94

Table 6-1 Alternative alignments for sodium hypochlorite .......................... 98

Table 7-1 Generic impact assessment steps ................................................ 100

Table 7-2 Overview of alignments by category .......................................... 103

Table 7-3 Overall assessment of health options .......................................... 110

Table 7-4 Overview of impacts of alternative alignment options - no

derogation rule/safety clause ................................................................... 110

Table 7-5 Overview of impacts of alternative alignment options - with

derogation rule/safety clause ................................................................... 111

Table 7-6 Economic impacts - million EUR per year ................................. 113

Abbreviations used

Acronym Description

IA Impact Assessment

CLP Classification, Labelling and Packaging of Substances and Mixtures

GHS Globally Harmonized System of Classification and Labelling of

Chemicals (GHS)

MARS Major Accident Reporting System

SPIRS SEVESO Plants Information Retrieval System

EU-VRI European Virtual Institute for Integrated Risk Management

TDDC Tetracholodibenzoparadioxin

MAHB Major Accident Hazards Bureau

GHS Globally Harmonised System

C&L Classification and labelling


SDS Safety data sheet

ILO International Labour Organisation

FEA European Aerosol Federation

HSE Health and Safety Executive

LPG Liquefied petroleum gas

DSD Dangerous Substance Directive

SRS Safety requirement specification

DPD Dangerous Preparations Directive

STOT Specific target organ toxicity

EEB European Environmental Bureau

AISE Association for Soaps, Detergents and Maintenance Products

CA Competent Authority

MS Member State

BLEVE Boiling liquid expanding vapor explosion

CFC Chloro-Fluoro-Carbon

SPIN Substances in Products in the Nordic Countries

NTP Normal temperature and pressure

TWG Technical working group

Seveso II Seveso II Directive

ATEX Explosive Atmospheres Directive

IPPC Integrated pollution prevention and control

Impact assessment of adapting Annex I of Seveso II I to CLP 1


1 Executive summary

This report includes analysis for a potential impact assessment of adopting

Annex 1 of the Seveso II Directive to the GHS1.

Seveso Directive In 1982, the first legislation to prevent and control major accidents at industrial

establishments – the so-called Seveso Directive (EU Directive 82/501/EEC) –

was adopted. On 9 December 1996, the Seveso Directive was replaced by

Council Directive 96/82/EC on the Control of major-accident hazards

involving dangerous substances, referred to as the Seveso II Directive. This

directive was extended by the Directive 2003/105/EC on 16 December 2003.

The Seveso II Directive applies to some thousands of industrial establishments

where dangerous substances are present in quantities exceeding the thresholds

in the directive. Thresholds are assigned to a list of named substances and to

generic categories of substances and preparations as defined by the

classification criteria in Directive 67/548/EC on Classification, packaging and

labelling of dangerous substances (DSD) and Directive 1999/45/EC on

Classification, packaging and labelling of dangerous preparations (DPD).

CLP legislation On 20 January 2009, the new Regulation on classification, labelling and

packaging of substances and mixtures (CLP) entered into force. It aligns

existing EU legislation with the United Nations Globally Harmonised System

of classification and labelling of chemicals (GHS). The CLP Regulation will

replace Directives 67/548/EEC (DSD) and 1999/45/EC (DPD) after a transi-

tional period. Substances must be classified according to the CLP as well as the

DSD from 1 December 2010, and from 1 June 2015 the CLP will repeal the

DSD/DPD for both substances and mixtures (currently called preparations). In

order to define the scope of the Seveso II Directive there is a need to amend the

Directive and identify appropriate CLP categories corresponding to the 10 haz-

ard categories currently referred to in Annex I Part 2.

Alignment Although the two classification systems are similar and cover approximately

the same hazards, the CLP introduces new hazard classes and categories. It uses

new criteria for classification as well as other cut-off values, and it applies a

different approach to classification of mixtures. Many of the hazard categories

correspond well with each other, but especially with regard to health hazards

where the boundaries for classification of acute toxicity in the CLP are different

1 The report presents the results of the work under service contract with DG Environment

070307/2008/508287/ETU/A3. 2 All illustrations of alternative options for the toxicity classification are based on the fig-



from the existing very toxic and toxic categories, it is necessary to look at dif-

ferent options for aligning the two systems while maintaining the scope of the

Directive and the regulatory effect to the extent possible. Alignment issues are

considered in relation to:

• Health hazards (acute toxicity)

• Physical hazards

• Environmental hazards

• Mixtures and solutions.

The main issue is with health hazards, where there is no simple one to one

translation for the acute toxicity categories. The impact assessment has there-

fore focused on the health hazards where alternative alignments have been

compared.

1.1 Health hazard

For health hazards, the classifications according to the DSD includes the cate-

gories of toxic (T) and very toxic (T+). The CLP legislation includes the cate-

gories of Acute Toxicity Category 1 to Category 4 (hereafter called Acute Tox

1 to Acute Tox 4).

Simple alignments The simple alignments would include two alternatives, one where T is

translated by Acute Tox 2 and one where T is translated into Acute Tox 2 and

3, while T+ in both alternatives is translated by Acute Tox 1.

The two simple alignments have some significant drawback. If T is translated

by Acute Tox 2 only, then it means a reduction in scope. The other simple

alignment with T translated by Acute Tox 2 and 3 would on the other hand in-

crease scope.

Figure 1-1 shows how the translations would impact on scope. Figure 1-1 com-

pares the existing classification and the CLP categories of Acute Tox 1 to 4. It

differentiates between exposure routes where the inhalation route is further sub-

divided into vapour, aerosol and gas inhalation. For example, Acute Tox 1 align

with the existing T+ for dermal, inhalation vapour and gas, while it includes

less with regard to the oral and the inhalation aerosol exposure routes.



Figure 1-1 Illustration of difference between Seveso II health categories and the

CLP classifications2

Comparison of toxicity

classifcations

T+ T XnEU

1 2 3 4Oral

mg/kg

1 2 3 4inhal.

vapour

mg/l

inhal.

aerosol

mg/l

1 2 3 4

2 3 4inhal. gas

mg/l

ppm

1 32 4Dermal

mg/kg

0 25 200

0 5 25 50 200 300

0

0,1

0

0

0

0,5

0,5 2 2.5

2

20050 400 1000

0,50,05 0,25 1

500 2000 25001000

10

Boundary

for old

legislation

1

Gyenes

Given that the simple alignments result in either a significant decrease or in-

crease in scope, alternative mitigations approaches have been investigated.

These mitigation approaches include:

• Differentiation by exposure (uptake) routes;

• Use of named substances;

• Use of screening tool/decision tree approach; and

• Expansion of the derogation rule.

Exposure routes The differentiation by uptake or exposure means that the translation would vary

across the alternative exposure routes. As it can be seen from Figure 1.1, the

differentiation can not completely remove the changes to scope. For the oral,

dermal and inhalation gas routes, the problem remains as excluding Acute Tox

3 means a reduction in scope while including Acute Tox 3 leads to an increase.

Another drawback of the differentiation along the exposure routes is that in-

formation on the Data Safety Sheet and/or product labels only covers the three

main routes oral, dermal and inhalation, while the sub-routes for inhalation will

require more data.

2 All illustrations of alternative options for the toxicity classification are based on the fig-

ure "Comparison of toxic properties" by Zsusanna Gyenes , see JRC Technical Report

55141



Named substances Another way to avoid reductions in scope would be include more named

substances in Annex 1. There is already a list of named substances in Annex 1

Part 1. These are mainly substances where certain specific conditions means

that thresholds different from what follows form the classification category

were more appropriate. Most notable, the higher thresholds for petroleum prod-

ucts have prevented all gas/service stations becoming Seveso sites.

The investigation has shown that it is difficult to identify a shortlist of sub-

stances that would have to be included if for example only Acute Tox 2 is in-

cluded as T. The potential list of substances to be included as named substances

in Annex 1 Part 1 is presented in Table 5.6. The attempt to narrow down a short

list with only the most relevant substances has not been successful and this ap-

proach seems to result in either that not all substances will be covered or that

the list will be very long including also less relevant substances.

Furthermore, using named substances means an unequal treatment of existing

and new substances. A list of named substances can only be identified from

existing substances while new substances will be treated more favourable.

It will also discriminate between the substances for there is a harmonised clas-

sification and all the self classified substances. It is not known how many estab-

lishments which are in scope of Seveso II due to self classification and it is

therefore difficult to assess how much effect this approach will have in prevent-

ing a reduced scope.

A third approach to mitigate the effect on scope would be to introduce a screen-

ing procedure. This could include criteria that would aim to maintain the cur-

rent scope. The screening should be included as part of Annex 1 and would

mean that for substances in category Acute Tox 3, industry would have to as-

sess the LD50/LC50 values to determine whether the substance would be inside

or outside scope.

A disadvantage of this option is that the screening will discriminate between

substances where the relevant LD/LC values are available and those where they

are not available. In the future, the classifications might no longer include the

information about the LD and LC values that are needed screen the substances.

As test will be guided to the new boundary values it might be difficult to de-

termine the status according the previous LD/LC boundary values.

Instead of a screening in of substances, a screening too option could be a

screening out approach. It could have a default to include for example Acute

Tox 3 for the oral route except when it can be shown that the LD50 is above 200

mg/kg.

Apart from discriminating between existing and new substance, a major disad-

vantage of this option is that it requires further analysis and data collection

from the operators.

A fourth alternative to mitigate changes in scope would be amending the cur-

rent derogation rule so that it could exclude establishments from coming within

Screening

tool/decision tree

Derogation rule/

safeguard clause



scope. Currently, the derogation rule is very limited in what it can grant of re-

duced obligations. If it would allow for excluding substances if it can shown

that there are no major accident hazard potential then such an amended deroga-

tion rule could be applied to avoid increasing scope when choosing a simple

alignment option.

The alternative mitigation options could be combined to form a large number of

potential alignment alternatives for the health hazards. Through a process of

assessing each of the mitigation alternatives and combining them with simple

alignment, four key representative options have been defined and selected.

Table 1-1 Overview of alignment options for health hazards

Option T+ T Differentiated

exposure routes

Use named

substances

Use screening

tool

Option A Acute 1 +

screening

Acute 2 + screening Yes No Yes

Option B Acute 1 Acute 2 + Acute 3 (inhalation aerosol) Yes Yes No

Option C Acute 1 Acute 2 + Acute 3 (oral, inhalation

aerosol and gas)

Yes Yes No

Option D Acute 1 Acute 2 + Acute 3 No No No

Option A Introducing a screening procedure that enables the current scope to be

maintained is at the expense of a more complicated procedure where additional

information about LD and LC values has to be gathered.

Option B This option is based on the differentiated exposure route approach. It is a

narrow option by only including Acute Tox 3 for inhalation aerosols. This op-

tion requires more named substances to cover for both the oral Acute Tox 3 and

inhalation gas Acute Tox 3.

Option C Similar to Option B, this option is based on the differentiated exposure routes.

It is more inclusive than Option B as it covers Acute Tox 3 for four out the five

exposure routes. There is a reduction due to the T+ to T for area A5 and an in-

crease in scope by including A2b. If named substances can compensate for the

changed threshold values for A5 substances, then Option C will result in net

increase in scope from the A2b area.

Option D This option is more precautionary and includes Acute Tox 3 for also the dermal

exposure route. This leads to an increase in scope and again if the named sub-

stance compensation for T+ to T is able to prevent a decrease in scope for area

A5, this option will lead to even further increase in scope.

A variation of C and D is C* or D* where Acute Toxicity 2 is included as T+

for the inhalation aerosol route. The Area A5 was identified as critical and the

identification of named substances will include a long list.

Selected options

Variation C* and D*



The options A to D are illustrated at Figure 1-2 below.

Figure 1-2 Comparison of health hazard alignment options

IA Option A to D

T+ T XnEU

1 2 3 4Oral

mg/kg

1 2 3 4inhal.

vapour

mg/l

inhal.

aerosol

mg/l

1 2 3 4

2 3 4inhal. gas

mg/l

ppm

1 32 4Dermal

mg/kg

0 25 200

0 5 25 50 200 300

0

0,1

0

0

0

0,5

0,5 2 2.5

2

20050 400 1000

0,50,05 0,25 1

500 2000 25001000

10

Boundary

to old

legislation

1

A1 A2

A5a

A3

A7A6

A4

A2b

Option A DB COption A B, C, and D

T+ T

A5b

A8

The impacts of each option have been assessed. The assessment has been semi-

quantitative using indicators. It is very difficult to estimate with any degree of

accuracy the impacts.

• The impacts have been assessed through the following indicators:

- For each of the "areas" shown on Figure 1-2, which could be either in

or out depending on the specific options, the number of substances

have been identified.

- A survey and other input from Member States on the number of im-

portant substances in each "area" have been used as indicator for im-

portant. Relative change in the number of substances included is used

as indicator for impact on number of establishments.

- The administrative effort is difficult to estimate. The change to CLP

and REACH will have some one-off costs for all industries. The dif-

ference in additional administrative effects between the alternative

alignment options can only very roughly be assessed.

- Assessment of the impact on the protection level based on a scoring of

substances that could change status. The scoring was based on the ma-

jor accident potential associated with each substance.

Assessment of

impacts



• Difficulties in assessing impacts on scope from alternative alignment op-

tions:

- Classification of a given substance can vary from company to com-

pany;

- Limited data on why companies have been covered by Seveso II (e.g.

how many fall within the scope due to health hazards is not known);

- Effect of changes in substance covered depends on many factors (e.g.

establishment already Seveso II site, the company response);

It is therefore not possible to determine exactly how many establishments could

come under scope or no longer by in scope as result of the options. The assess-

ment can only be semi-quantitative.

The options are described and impacts presented in the below table.

Table 1-2 Overall assessment of health options

Option Description Scope and

regulatory attention

Administrative

effort

Protection level

Option A Screening tool approach for boundary

areas of T+ and T

Maintain scope but

may discriminate

between existing

and new substances

Higher than other

options due to the

screening approach

No change com-

pared to current

level

Option B T+ to Acute 1 plus named substances

for missing Acute 2 areas

T to Acute 2 and Acute 3 for inhala-

tion aerosol

Named substances for missing Acute

3 areas

Possible reduction

in scope - depend

on degree of com-

pensation by named

substances

Slightly higher due

to differentiated

exposure routes

Protection level

varies with scope -

possible reduction

Option C T+ to Acute 1 plus named substances

for missing Acute 2 area

T to Acute 2 plus Acute 3 for oral

and inhalation (aerosol and gas)


3 area in dermal exposure route

Possible increase in

scope from more T

substance but re-

duction in scope

from T+ substances

having higher

thresholds

Slightly higher due

to differentiated

exposure routes

Protection level

varies with scope -

possible small in-

crease

Option D T+ to Acute 1 plus named substances


T to Acute 2 plus Acute 3 for all

uptake routes

Increase in scope No change com-

pared to current

level

Protection level

varies with scope -

increase

There is no simple conclusion as there are advantages and disadvantages asso-

ciated with each option. The overall conclusion is likely to depend very much

on whether an amended derogation rule and a safeguard clause are introduced.



Under this scenario, Option D seems to be most favourable. It will prevent any

decrease in scope and if there would be an increase where new sites will be

brought in though they represent no major accident hazard potential, the dero-

gation rule can prevent that from happening.

For the translation of T+ with Acute 1, the possible decrease in scope that re-

sults from the inhalation aerosol uptake route, the safeguard clause could mean

that if establishments are to fall out of scope they can be kept in.

The administrative costs are the least with this option as it is using a simple

alignment. The derogation process can resource demanding but it will only be

used if in situations where there is risk a significant increase and then by avoid-

ing unwanted increase in scope, it prevents additional costs.

Without the derogation rule, Option D could lead to significant increase in

scope. Under this scenario, Option C - possibly in the variant C* where T+ is

translated into Acute Tox 1 and 2 for the inhalation aerosol uptake route -

seems most favourable. Option C is reasonable close to the current scope,

though it could lead to an increase in scope with regards to the oral exposures

route and small decrease with the dermal route.

A specific issue that was identified in the assessment is that when T+ only is

being translated into Acute Tox 1 it would for one particular exposure route

mean that scope could be significantly reduced. This is due to the difference in

threshold values between T+ and T. There is not an easy solution to the prob-

lem. In the scenario without the derogation rule, where Option C is the pre-

ferred option, the variation C* could be considered. It could however result in

an increase in scope. With the derogation rule/safety clause in place and the

simple alignment Option D as the preferred option, the problem can only be

mitigated by using the safety clause. So if any establishments seem to fall out

of scope, the clause could be used to maintain scope.

In terms of protection level, the options vary in proportion to scope. If the op-

tion leads to a reduction in scope, the protection level is likely to be reduced

and if scope is increased so is the protection level. This assessment is based on

the approach with a scoring of individual substances. This scoring shows that

areas A1 to A7 all includes both high and low scored substances. Therefore

when increasing scope and including more high scored substances (those with

higher major accident potential) also lead to a number of low scored substances

to be included.

Other Options In principle a large number of alternative options could be defined. The

selected options were developed through a systematic process. However, some

aspects have only been identified as a result of the analysis of the selected op-

tions.

One dimension that was not integrated in the development of the options is the

importance of the health hazards related to the different exposure or uptake

routes. The inhalation route is the most serious in terms of potential health ef-

With derogation rule

and safeguard clause

Without derogation

rule and safeguard

clause

T+ for inhalation

aerosol

Protection level



fects, followed by the dermal exposure route while the oral exposure route is

the least important in the context of the Seveso II Directive.

The differentiation by sub-exposure routes described above was aimed at

achieving a more close one to one translation of the health categories and it

therefore includes the differentiation of the inhalation route in three sub-routes.

The analysis has shown that this approach leads to increased administrative

costs and it does not fully mitigate the impact on scope.

Option E and E* Instead an alternative option that combines the importance of the uptake routes

and the advantage of a simple alignment could be considered (Option E/E*).

Such an option would be to include:

Inhalation: Acute Toxicity Category 2 and 3;

Dermal:

Acute Toxicity Category 2 and 3; or

Acute Toxicity Category 2 only.

Oral: Acute Toxicity Category 2.

For the dermal exposure route, there is choice as whether to include Acute Tox-

icity Category 3 or not. Including Acute 3 brings in more substances and

thereby increases scope, while leaving out Acute 3 reduces scope.

Figure 1-3 Illustration of Option E and E*

IA Option E and E*

T+ T XnEU

1 2 3 4Oral

mg/kg

1 2 3 4inhal.

vapour

mg/l

inhal.

aerosol

mg/l

1 2 3 4

2 3 4inhal. gas

mg/l

ppm

1 32 4Dermal

mg/kg

0 25 200

0 5 25 50 200 300

0

0,1

0

0

0

0,5

0,5 2 2.5

2

20050 400 1000

0,50,05 0,25 1

500 2000 25001000

10

Boundary

to old

legislation

1

A1 A2

A5

A3

A7A6

A4

A2b

A8

T+ T

Option E, E* Option E E*



The impacts on scope of an option which differentiate between the main uptake

routes and include Acute Tox 3 for inhalation (and dermal) is different from

Option B to D as analysed above as it will mean a combination of increased and

decreased scope. There will be more substances included from inhalation

through the sub-exposure routes vapour and gas, while there will be a reduction

for the oral exposure route.

It is very difficult to establish the link between substances and establishments

as described in the analysis. Whether such a combination therefore will result in

a limited net impact is difficult to estimate. Using the simplified indicator ap-

proach which assumes a proportional relationship between number of sub-

stances and establishments, the net impact on scope of this option could be

moderate. In particular if Acute 3 is not included for the dermal route, the im-

pact on scope could be very limited.

The administrative effort of differentiating only between the three main expo-

sure routes will be limited as the information should be available at product la-

bels and in the SDSs. The impact on the protection level varies with scope.

Overall the alternative options E and E* could be relevant to consider as they

could results in a limited impact on scope - though based on a combination of a

decrease for oral (and dermal) exposure routes and an increase for inhalation

(and dermal) - and low administrative costs.

1.2 Physical hazards

One to one translation In terms of options for the categories related to physical hazards, in most cases

the translation is a one to one. The main exception regards the aerosols.

Aerosols The analysis of aerosols revealed the following:

• An estimate of the one-to-one translation based on average LPG or flam-

mable propellant content indicated a level around 30 per cent. This is used

to convert the LPG thresholds of 50/200 into aerosol thresholds of 150 and

500 tonnes.

• Surveys of the impact of the options with 150/500 based on total aerosol

quantity indicate either a small decrease or increase in scope.

• Some installations will fall outside the scope and some will fall within the

scope of the Seveso II Directive compared to the current situation.

• Overall, no major changes in scope are expected.

• The hazard potential posed by storage of aerosols is debatable. There are

differing views on whether large-scale storage poses a major-accident haz-

ard potential or not.

Impacts of Option E

and E*



• Overall, it is concluded that the impact of the proposed translation will be

limited, though new installations might fall within the scope of Seveso II.

1.3 Environmental hazards

One to one translation Considering the environmental hazard categories, in principle a one-to-one

translation is achieved with no impacts on substances classified as N; R50 and

N; R51/53.

• For some individual substances, the classification may change;

• Some substances may no longer require classification, and some sub-

stances not previously classified may now need classification;

• Overall, the scope is expected to remain unchanged.

1.4 Mixtures and solutions

The classification of mixtures according to CLP (GHS) can be stricter or less

strict than the classification according to the Preparations Directive.

Whether the result is an increase or a reduction in the scope or regulatory atten-

tion depends on the classification category and route, the actual LC50/LD50

value(s) of the ingredient(s) in relation to GHS classification boundaries and

the concentration of the classified ingredient(s) in the mixture.

The investigation of the impact of CLP on classification of mixtures and how it

will affect Seveso II indicates that scope can be change in either direction.

The rules for classification of mixtures are quite complex but example on both

more and less stringent classifications have been found.

The fact that when there is no data on one substance that is used in a mixture,

then the classification is more strict, means that as REACH over time will in-

crease the knowledge of substances, mixture classifications are likely to move

from strict to less strict classifications over time.

One of the effects is a modification in the environmental classification. Generic

concentration limits for classification of mixtures containing environmentally

hazardous substances have been removed and instead multiplying factors (M-

factors) for highly toxic components of mixtures have been introduced3.

Overall, it is not possible to predict the impacts of the transition to the CLP

with respect to scope changes. The combination of a derogation rule and a

3 The case of sodium hypochlorite has been brought forward as an example of an increase

in scope due to the use of the M-factor for the environmental classifications. The issue of

sodium hypochlorite will further analysed in the impact assessment of options to amend the

Seveso II Directive (study expected to be available late 2010).



safeguard clause could reduce the risk of any major scope change. This would

require that current derogation possibility is amended to cover more situations

and allow for exclusion of activities and establishments from scope of the

Seveso Directive.

1.5 Impacts of options

1.5.1 Economic impacts

Based on the above assessment of options, the following economic impacts

have been identified:

Cost for industry:

• Overall costs for reviewing existing inventories and reviewing and under-

standing the new Annex 1. This cost element is common for all three haz-

ard groups.

• Physical hazards: Only minor changes no economic impacts has been iden-

tified apart from the case of aerosols.

• Environmental hazards: One to one translation and no economic impacts

identified.

• Health hazards: Alternative alignment options that require some adminis-

trative effort to implement and potentially change scope. Change in scope

means a change in the number of establishments covered by the obligations

of the directive. They will either save the administrative costs related to

compliance with the directive or they will have to pay these additional

costs.

Costs for the CA:

• One-off costs of adapting to a revised Annex I;

• Costs or savings related to change in number of establishments.

The costs are shown as annual costs. It is important to emphasise that the esti-

mated values provide a rough order of magnitude estimate. The assessment is

subject to uncertainty as a set of assumptions has been applied to derive the

quantification of the impacts.



Table 1-3 Overview of economic impacts (order of magnitude) -

million EUR per year

Type of impact Estimated cost

impact on industry

Estimated cost impact on

CA4

General adaption to new Annex 1

One off adjustments and review of

substance inventories etc (total costs)5

≈ 1.7 ≈ 0.4

Physical hazards

Change in scope due to aerosol option

(0-50 new establishments)

< 1 <0.1

Other categories No costs estimated No cost estimated

Environmental hazards No costs estimated No cost estimated

Health hazards

Administrative adaption (Option C or

D)

≈ 2 - 3 No cost estimated

Scope change (Option C or D) ≈ 0.5 - 4 ≈ 0.5

Total ≈ 5.2 - 9.7 ≈ 1

Source: Consultant's estimates

These cost estimates can be compared to the administrative costs of the Seveso

II Directive as presented in the recent study on existing administrative burdens

of selected EU directives. The study estimated the total annual administrative

costs for industry to be about EUR 52 million per year6.

The above estimated costs range of 5-10 million EUR per year can also be

compared to the estimated costs of the overall adaptation to the CLP due to re-

classification, re-labelling, changes to it systems etc7. The costs of overall tran-

sition to the CLP have been estimated to almost 500 million EUR though this

costs are for a larger population of industries than the around 10,000 Seveso II

establishments and it is a net present value for about 5-7 years transition period.

(It would be about 80 to 100 million if annualised at 4% over 5-7 years).

Net and gross impacts Establishments that are already Seveso II sites might not experience much cost

savings as a result of the changed status. They have already invested in safety

reports, safety systems and emergency plans and in physical modifications if

that were necessary. They will only save future updates of the plans. In terms of

4 The costs for CA in relation to scope changes are assumed to be around 10% of the cost

for industry per establishment for inspection etc. 5 One-off costs of 7.7 million EUR annualised over 5 years and a discount rate of 4%. One-

off costs for CAs at 1.8 million annualised over 5 years and 4%. 6 Final Report on Modules 3&4 for Environment Priority Area July 2009 - part of an

EU (DG ENT) project on baseline measurement and reduction of administrative costs

(which included the Seveso II Directive). 7 COM(2007) 355 final: Impact Assessment Related To The Implementation

of the GHS in Community Law

Costs in perspective



financial impacts on industry, there is likely to be asymmetric effects so the

cost savings for one establishment falling out of scope will not offset the addi-

tional costs for a new establishment coming into scope. The total aggregated

costs could therefore increase even if there is no net increase in the number of

establishments falling within scope.

1.5.2 Environmental impacts

The environmental impacts are those related to the protection level and the en-

vironmental hazards. As the scope with respect to the environmental hazard

categories are estimated to be more or less unchanged, there are no environ-

mental impacts from adapting Annex 1 of the Seveso II Directive to CLP.

1.5.3 Social impacts

The potential social impacts (in accordance with the EU IA definitions) could

include health impacts and employment effects due to the economic costs on

industry.

The considerations of the protection level indicate very limited impacts for

most of the health hazard options. Options C or D more or less maintain the

current scope, and therefore they also leave the protection level unchanged.

It is not possible to apportion the costs for industry to specific industries. The

data on Seveso II establishments does not allow for that. Overall, the annual

costs estimated at a range of 5 to 10 million EUR would if they were divided

among the entire 9700 establishments amount to between 500 and 1000 EUR

per establishment. Though there could be specific sites that will experience

one-off costs that are sufficiently high to affect their profitability, overall the

economic effects seems too be limited. Therefore, no employment impacts can

be identified.

1.6 Overall assessment

The assessment of impacts that could occur as a result of adapting Seveso II to

the CLP legislation has been based on a number of indicators. The overall as-

sessment is that changes in scope and regulatory attention are likely to be rela-

tively moderate. The magnitude of impacts depends, however on whether an

amended derogation rule and a safety clause are introduced. Due to the gradual

phase in of the CLP and REACH, classifications - in particular for mixtures -

could change over time. It is therefore difficult to predict the impacts. Having

increased flexibility through an amended derogation rule could prevent un-

wanted changes to scope. Therefore with a derogation rule, impacts are likely to

be less than without the rule.

Health impacts

Employment impacts



2 Introduction

This is the Draft Final Report on the project "Support to Impact Assessment of

Adapting Annex 1 of Seveso II into GHS".

The impact assessment study into possible options for adapting Annex I of

Seveso II to the CLP8 takes its starting point in the Terms of Reference (ToR)

produced by DG ENV, dated 6 June 2008. In response to this request for ser-

vices, COWI submitted a proposal in July 2008. COWI was selected to conduct

the IA, and the kick-off meeting with DG ENV was held in Brussels October

24 2008.

The DRAFT final report will serve as input for the Impact Assessment that is to

be drafted from DG ENV.

The report contains the following chapters:

• Chapter 1 Executive summary

• Chapter 2 Introduction (including background Seveso II and CLP)

• Chapter 3 Approach and input to the impact assessment

• Chapter 4 Impact assessment of alignment of categories related to physical

hazards

• Chapter 5 Impact assessment of alignment of categories related to health

hazards

• Chapter 6 Impact assessment of alignment of other categories and other

issues

• Chapter 7 Conclusions

The project on supporting the impacts assessment was undertaken in parallel to

the work of the Technical Working Group (TWG) on Seveso II and the GHS.

8 The Technical Specification for the project mentions GHS but given that GHS is now

implemented in the CLP, the relevant options are for adoption to CLP.



This impact assessment draws extensively on the work done in the TWG. Key

data and information have been provided by the members of the TWG.

It is important to note that options to be covered in the impact assessment are

not the same as the ones developed and agreed by the TWG. The options con-

sidered in this impact assessment incorporate many aspects from the TWG

definite options but they are organised differently.

2.1 Background and objectives

2.1.1 Seveso II

The goal of this chapter is to present background material that provides basic

information about the Seveso II Directive. This will include detailed informa-

tion about the establishments and industries that fall inside the scope of the Di-

rective, as well as more information of the formal background of the Seveso II,

namely the related regulation, CLP (CLP Regulation (EC) No 1272/2008 on

Classification, labelling and packaging of substances and mixtures from 16 De-

cember 2008) and the GHS classification.

Information about regulations is mainly documentation available online on the

European Commission's web pages (DG ENV in particular). The information

regarding industries and Seveso II establishments is based on previous studies

that have investigated the effectiveness of the Seveso Directive and enforce-

ment of Seveso II Directive. Further, these studies provide general insight into

some of the industries that fall under the Seveso II Directive including the char-

acteristics of the establishments, their administration of the Directive's imple-

mentation, the costs and the differences between being in the lower and upper

classification tiers.

The development of the Seveso II was initiated after the major accident in

Seveso, Italy in 1976. In short, the accident occurred at a manufacturing plant

for pesticides and herbicides. A vapour cloud containing tetracholodiben-

zoparadioxin (TCCD) was released from a reactor. As a consequence, more

than 600 persons were evacuated from their homes and more than 2000 treated

for dioxin poisoning. This accident gave name to the Directive. The first

Seveso Directive was adopted in 1982 (EU Directive 82/501/EC). On 9 De-

cember 1996, the Seveso directive was replaced by the Seveso II Directive

(Council Directive 96/82/EC) and extended by Directive 2003/105/EC. The

Seveso II Directive applies to some thousands of industrial establishments

where dangerous substances are present in quantities exceeding the thresholds

in the directive. Thresholds are assigned to a list of named substances and to

generic categories of substances and preparations as defined by the classifica-

tion criteria in Directive 67/548/EC on Classification, packaging and labelling

of dangerous substances (DSD) and Directive 1999/45/EC on Classification,

packaging and labelling of dangerous preparations (DPD).

Aim of the Directive The aim of the Seveso II Directive is twofold. The two aims are to prevent

major-accident hazards involving dangerous substances, and to limit the conse-

History of the

Seveso II Directive



quences of the accidents that do occur - both for people (health and safety is-

sues) and for the environment. The Directive addresses the risk of major acci-

dents through the quantities of dangerous substances that are present at an es-

tablishment. The first level (named lower tier) applies to the establishments

where the stored quantity of dangerous substances is equal to or above the

lower limit, but below the higher limit. The second level (named upper tier)

applies to the establishments holding a quantity of dangerous substances thathat

is equal to or higher than the the higher threshold limit. Establishments within

the lower and upper tier are named Seveso II establishments, and these estab-

lishments must follow the regulation and guidelines contained in the Seveso II

Directive. The Seveso II Directive does not cover nuclear safety, the transport

of dangerous goods by road, rail sea or air, intermediate storage outside estab-

lishments and the transport of dangerous substances by pipeline.

Sccope of the directive The directive sets out in Annex 1 Part 2 10 categories of dangerous substances

that are covered by the directive. For these categories the qualifying quantities

are included. Annex 1 Part 1 includes a list of named substances that can be

considered as exemptions from the general 10 categories of dangerous sub-

stances. They are exemptions where either higher or lower thresholds apply.

The list of named substances has been developed based on experience accidents

and practical considerations. For example, a number of petroleum products are

included with higher thresholds in order to avoid inclusion of the large number

of filling stations.

Annex 1 of the directive is the focus for this impact assessment as the 10 cate-

gories of dangerous substances have to be adapted to the new CLP classifica-

tion of substances.

A major accident The general definition of a major accident: 'major accident' shall mean an

occurrence such as a major emission, fire, or explosion resulting from uncon-

trolled developments in the course of the operation of any establishment cov-

ered by the Directive, and leading to serious danger to human health and/or

the environment, immediate or delayed, inside or outside the establishment, and

involving one or more dangerous substances (general definition of Article 3 of

the Directive, transcribed from Wettig & Porter 19999).

Measures To achieve the aims of the Directive, some measures have been put in place. On

one hand, the Directive sets forward a number of control measures to prevent

major accidents, and, on the other hand, the Directive sets forward control

measures to limit the consequences of a major accident. All Seveso II estab-

lishments must send a notification to the competent authority and establish a

major accident prevention policy. In addition, upper tier establishments must

draw up a safety report and establish a safety management system and an emer-

gency plan. 10

9 Wettig, J. & Porter, S. (1999) The SEVESO II Directive, February European Commission

10 Background information about the Seveso II Directive is from the DG ENV web page:

http://ec.europa.eu/environment/SEVESO/index.htm;



According to a summary of data from SPIRS, there are 9725 establishments

included in the Seveso II (November 2009). Out of these, 5227are included in

the lower tier, and 4496 are included in the upper tier.

Figure 2-1 List of SEVESO establishments, based on SPIRS (as of November 2009)

Country Total

number of plants

Upper Tier Lower Tier Not

known/ not applicable

Germany 2119 1071 1048

UK 1147 411 736

Italy 1117 519 598

France 1106 553 553

Spain 673 267 406

Netherlands 384 221 163

Sweden 379 199 180

Poland 366 158 208

Belgium 365 174 191

Romania 277 115 162

Finland 264 128 136

Czech Republic 190 115 75

Greece 189 83 106

Portugal 164 57 107

Austria 146 80 64 2

Hungary 144 64 80

Bulgaria 135 54 81

Denmark 121 31 90

Ireland 88 34 54

Slovakia 78 41 37

Latvia 63 30 33

Slovenia 60 23 37

Lithuania 53 19 34

Estonia 50 25 25

Luxembourg 21 8 13

Cyprus 16 10 6

Malta 10 6 4

TOTAL 9725 4496 5227 2

Source: SPIRS

Some of the more important sectors that are covered by the Seveso II Directive

have been described in more detail in a report from the SEVESO Inspection

Series - Enforcement of SEVESO II: An analysis of compliance drivers and

barriers in five industrial sectors. The findings reported in the report point to

http://ec.europa.eu/environment/SEVESO/legislation.htm, both accessed latest on 1 Octo-

ber 2009

Key sectors in

Seveso II



major differences in the 'Seveso II-structures' of the industries. Some of the

main characteristics are presented below:

Mineral oil refineries:

• Most, if not all, refineries are upper tier Seveso II establishments.

Pharmaceutical industry:

• Pharmaceutical plants can be small, medium-sized or large, consisting of

both plants in the upper and lower tiers

• The plants usually have a high compliance with Seveso II requirements -

as production generally follows Good Manufacturing Practices11.

• Usually, the unloading and storage of solvents is the reason why Seveso II

regulations apply to the pharmaceutical industry.

Fertilizer production

• The explosion at Toulouse, France, fertilizer plant demonstrated that fertil-

izer manufacturing can be dangerous and that large holdings of ammonium

nitrate pose a safety risk

• For international producers, compliance with technical rules is perceived

as more important than compliance with safety management system rules

• Reputation is not given a high priority.

Batch processing

• Wide variety of companies (in terms of size, types and number of products

they produce, type of substances handled, process complexity, and organ-

isational structure)

• Generally the sector has a positive compliance attitude.

LPG storage

• LPG storage comprises different types of activities including storage and

filling of aerosols.

• The LPG sector, and specifically the larger companies and multinationals,

is very familiar with safety regulations, as safety standards in this sector

were established decades ago. Consequently, regulations adopted by the

sector itself are often more readily accepted than regulation enforced by

regulatory authorities. Nonetheless, compliance levels with technical regu-

11 Good Manufacturing Practices is a worldwide standard for the control and management

of manufacturing and quality control testing of pharmaceutical products.



lation appear to be fairly high. Very small companies may be less knowl-

edgeable about safety but may adopt statutory regulation with less resis-

tance than large companies.

• The level of safety-related knowledge in this sector is higher among multi-

national companies than among small, local or regional companies.

The above characteristics were extracted by working groups established under

the auspices of the Seveso II regulatory framework, in the Seveso Inspection

Series - Volume 3. The working groups also discussed the pros and cons of

various, specific regulation of the Seveso II Directive.

Some of the major conclusions from the Seveso Inspections Series study were

that:

• ''Except for implementation of some rules and the direct or indirect use of

classical interventions, limited differences are found between Member

States.''

• "All Member States deal with multiple interpretations of rules, perform

joint inspections and cope with the associated challenges of coordination

and the (continuous) updating and improving of inspection methods."

• "Self-compliance, image and reputation are major drivers for many com-

panies, but this aspect is not yet integrated in authorities' enforcement

strategies"

• "A challenge lies in improving the clarity and enforceability of rules, for

example 'hard' versus 'soft' rules"

• "The level of knowledge and training of inspectors influences the probabil-

ity of inspection and the probability of violations being detected during in-

spections

• On a European level, it was recommended that the enforceability of legis-

lation should be a subject which legislators take into account"

• "Effective enforcement is often hampered by national level challenges,

such as resource limitations and lack of clear criteria for enforcing soft

rules"

• "Understanding the typical compliance profiles of different industrial sec-

tors may also assist inspectorates in developing more effective enforce-

ment strategies"

(SEVESO Inspection Series pp. 40-42)

Implementation

issues



2.1.2 GHS & CLP

CLP In 2008, the new Globally Harmonised System (GHS) of classification and

labelling of chemicals was introduced into EU legislation. The GHS was intro-

duced via the CLP Regulation (EC) No 1272/2008 on Classification, labelling

and packaging of substances and mixtures from 16 December 200812. The CLP

regulation aligns the classification and labelling rules in the EU to the Globally

Harmonised System of Classification and Labelling of Chemicals - a classifica-

tion that is agreed on the UN level.13

In practice, the scope of the CLP includes substances and mixtures including

C&L of plant protection products and biocides. The regulatory instrument guid-

ing this is the regulation based on Art. 95 of the EU Treaty dealing with har-

monisation of the internal market.14

GHS The background for adopting the new GHS classification is that countries

acquire information about dangerous substances mainly through Labelling or

Safety Data Sheet (SDS). However, existing laws or regulations in the area tend

to differ in terms of classification implying that labels or SDSs for the same

product differ across borders. Examples of different and misleading labelling of

dangerous substances are the varying labels previously instead of the new GHS

term 'danger' are 'toxic', harmful', non-toxic', hazardous', and 'not dangerous'

depending on the country.15 Therefore, recognition of the need for an interna-

tionally harmonized approach to classification and labelling spurred the devel-

opment of the GHS. The development of the GHS was also expressed e.g. via a

need to comply with the ILO Convention and Recommendation (1980-90s) on

the harmonization of systems of classification and labelling for the use of haz-

ardous chemicals at work, combined with increased global trade and the need

for safety systems nationally.

The GHS introduces new classification criteria, hazard symbols (pictograms)

and labelling phrases, while taking account of elements which are part of the

earlier EU legislation. This includes harmonized criteria for the classification of

substances and mixtures according to their physical, health and environmental

hazards; and harmonized hazard communication elements (including require-

ments for labels and safety data sheets). The GHS covers all hazardous chemi-

cals, although, the mode of application of its hazard communication elements

may vary by product category or stage in the lifecycle. Target audiences for the

12 The CLP regulation amends and repeals Directives 67/548/EEC and 1999/45/EC (pack-

aging and labelling of dangerous substances and preparations, respectively, and amending

Regulation (EC) No 1907/2006 entered into force on 20 January 2009) 13 http://ec.europa.eu/environment/chemicals/ghs/index_en.htm, accessed latest on 011009

14 Jensen-Korte, Dr. U. (2009) The main features of the CLP regulation, European Com-

mission, presentation at 'EU & world wide rules for classification, labelling & packaging of

chemicals, June 17th 2009 15 Jensen-Korte, Dr. U. (2009) The main features of the CLP regulation, European Com-

mission, presentation at 'EU & world wide rules for classification, labelling & packaging of

chemicals, June 17th 2009



GHS include consumers, workers, and emergency responders 16 17. The GHS is

not in itself legally binding, although its introduction via the CLP makes it le-

gally binding in the EU.

Some of the principles guiding the implementation of the GHS particularly im-

portant in the SEVESO context are to keep the scope of the SEVESO Directive

as close to the old EU system as possible, and to align as closely as possible to

the GHS format and terminology - applying terms such as mixtures and haz-

ardous instead of preparations and dangerous. Other principles are to apply the

general principles of the GHS and to introduce the GHS criteria for data inter-

pretation, classification and labelling. Another important issue is that the cur-

rent level of protection should be maintained.

CLP and Seveso II The CLP Regulation will replace Directives 67/548/EEC (DSD) and

1999/45/EC (DPD) after a transitional period. Substances must be classified

according to CLP as well as DSD from 1 December 2010 and from 1 June 2015

the CLP will replace DSD/DPD for both substances and mixtures (currently

called preparations). In order to define the scope of the Seveso II Directive

there is a need to amend the Directive and identify appropriate CLP categories

corresponding to the 10 hazard categories currently referred to in Annex I Part

2.

Although the two classification systems are similar and cover approximately

the same hazards, the CLP also introduces new hazard classes and categories.

To some extent, it uses other criteria for classification as well as other cut-off

values, and it uses a different approach for classification of mixtures. Many of

the hazard categories correspond well with each other, but especially with re-

gard to health hazards where the boundaries for classification of acute toxicity

in the CLP are different from the existing very toxic and toxic categories it is

necessary to look at different options for aligning the two systems while main-

taining the scope of the Directive and regulatory effect to the extent possible.

2.1.3 Objectives of the impact assessment

Annex 1 Annex 1 of the Seveso II Directive includes two parts, Part 1 contains a list of

named substances, while Part 2 contains the categories of dangerous sub-

stances.

Part 2 The objective of this study is to undertake an impact assessment that following

the EU IA guidance investigates alternative alignment options for the adaption

of Annex I of Seveso II Directive to the CLP legislation. The change in classi-

fication affects the categories of dangerous substances in Part 2 so the impact

16 United Nations Economic Commission for Europe (2007), The Globally Harmonized

System of Classification and Labelling of Chemicals (GHS), Historical Background AND

Purpose, Scope and Application 17 http://www.unece.org/trans/danger/publi/ghs/ghs_welcome_e.html, accessed latest

011009



assessment is focused on the options for aligning the categories in Annex 1 Part

2. More specifically, the alignment issues are considered in relation to:

• Physical hazards;

• Environmental hazards;

• Health hazards (acute toxicity); and

• Mixtures and solutions.

The study is focused on the areas where there is a choice is most important

which is in relation to the health hazards.



3 Approach and input to the impact assessment

3.1 Approach to the impact assessment

The impact assessment has followed the IA guidelines. Section 7.1 includes a

summary of all elements of the IA.

The key analytical parts of this impact investigate and compare alternative

alignment options for various hazard categories. The steps in assessment of the

options are presented in Figure 3-1 below.

Figure 3-1 Analytical steps in assessment of alignment options

Chapter 4, 5 and 6 presents the analyses which based on these steps cover the

alignment of the categories related to physical hazards, to health hazards and to

all other hazards and issues.



There are some general elements related to the last step, to identify and assess

impacts, and these generic issues are presented in this Chapter. Section 3.2 in-

cludes a discussion of the process of alignment and the resulting impacts while

Section 3.3 presents data and unit cost estimates related to the Seveso II re-

quirements.

3.2 Identification of impacts

3.2.1 The process of implementing the adapted Directive

The process of adapting Annex 1 of the Seveso II Directive to the CLP will in-

clude the following steps and elements:

1 Revised Directive is transposed in each MS and each CA revises na-

tional implementation and informs industry;

2 Companies review changes to determine if they are impacted and

submit a revised notification to the CA;

3 Companies where new establishments will be included under the Di-

rective due to adaption to CLP;

3.1 Avoidance activities so they are not included under the Directive:

a) Modify substance/mixture inventories to avoid coverage;

b) Supply change management;

c) Process modifications including substance substitution;

3.2 Possible inclusion of new industrial sectors subjected to the Seveso II

directive (due to inclusion of new substances or mixtures):

a) Safety reports etc;

b) Physical modifications to production or storage.

It means that there is likely to be some general activities that will the same in-

dependently of which options are chosen.

The costs of such activities should be considered in the overall assessment of

impacts, see Section 3.3.

3.2.2 Identification and assessment of impacts

The most important effect of alternative alignment options is the possible im-

pact on the scope of the Directive or the regulatory attention. Scope and regula-



tory attention are defined as follows in as defined in Trainor, M.T. et al

(2007)18:

• a change in the scope of installations regulated under Seveso II means in-

stances where an installation moves between being regulated under

SEVESO II and not being regulated under Seveso II, or vice versa; while

• a change in the regulatory attention of Seveso II for those installations that

are in scope, means instances where an installation moves between 'lower-

tier' and the more tightly regulated 'upper-tier' status or vice versa.

As mentioned above, companies that either move from the lower to the upper

tier or fall within the scope for the first time have to evaluate alternative re-

sponses or actions:

• Avoidance of any change in Seveso II status through process or supply

chain modifications;

• Compliance with the requirement of the directive, which could result in the

following type of activities:

- Preparation of notification and a major accident prevention policy

- Preparation of extensive safety report and a safety management sys-

tem with emergency plans etc.

- Technical modifications to manufacturing or storage facilities to re-

duce risks.

If the company decides to try to avoid falling within the scope or increased

regulatory attention the specific actions or responses could include:

• A reduction in hazardous materials inventories, which from the outset will

lower the potential hazard of the site and exclude them from Seveso II.

This adaption might foster a higher number of deliveries of a given sub-

stance, which in turn will mean a greater number of transport units on the

roads and the subsequent risk increase. Such risk tradeoffs will only be

identified not assessed as transportation risk is outside the scope of Seveso

II. This could transfer the issue up the supply chain. An example may be a

company that lowers its warehouse capacity and increases the number of

deliveries. This would imply that inventories increase elsewhere to just be-

low the qualifying quantity, perhaps at sites where the level of profession-

alism is lower. It could also lead to concentration of a few sites with large

inventories.

18 Trainor et al, 2007: DRAFT REPORT 31.3.07. Investigation into the Implications in

Terms of Acute Toxicity to People of the Classification Options for the EU SEVESO II

Directive when the EU Adopts the Globally Harmonised System of Classification and La-

belling of Chemicals (GHS) (Not available to the public)

Avoid change in

Seveso II status



• Substitution of the substances. The effect of this measure depends on re-

placement substances. In most cases, this will be an intentional, beneficial

and legitimate effect of the regulation.

If the companies choose to comply with the directive, they must comply with a

guideline, according to articles 6-7 and 9 of the Directive. Establishments that

fall under the Seveso II lower threshold (i.e. art. 6 and 7) must submit a notifi-

cation and a policy for major accident prevention to the competent authority.

The prevention policy must be implemented in the company.

Establishments that fall under article 9 (the high threshold) must present an ex-

tensive safety report with very detailed information about the establishment

demonstrating that a major-accident prevention policy and a safety manage-

ment system are in place, that adequate major-accident hazards have been iden-

tified, that adequate safety and reliability have been incorporated, that internal

emergency plans have been drawn up, and that they provide sufficient informa-

tion to the competent authority to enable decision making19.

The assessment of the safety situation and major accident scenarios could result

in a need for physical modifications to the establishment.

These measures might seem difficult to comply with, and a reaction from the

affected enterprises to the potential inclusion in Seveso II could be that of

avoidance. This implies that instead of complying and registering for becoming

a Seveso II establishment, some companies will seek to avoid this in any possi-

ble way.

In the subsequent section, the potential costs of each type of response to

changes in the Directive are analysed and quantified to the extent possible.

Protection level In addition to the net costs from changes in scope of the directive, scope

changes will also have impact on the protection level. The benefit from in-

creased protection level (or cost if scope is decreased) is difficult to quantify.

For some of the categories, a qualitative discussion is included, while for the

toxicity categories, an analysis of a number of substances that are either in-

cluded or excluded from scope has been performed. It based on scoring of the

major accident hazard potential attached to each substance.

3.2.3 Uncertainties

There are many uncertainties about what will happen and in particular in terms

of the specific consequences of the adaption of Annex 1 to the CLP. Therefore,

the overall assessment cannot be very specific and provide quantitative results.

Key uncertainties include:

19 Extracted from the article 6-7 and 9 of the Council Directive 96/82/EC, Seveso II Direc-

tive

Comply with change

in Seveso II status



• Classification of a given substance can vary from company to company;

• Limited data on why companies have been covered by Seveso II (e.g. how

many fall within the scope due to health hazards is not known);

• Effect of changes in substance covered depends on many factors (e.g. es-

tablishment already Seveso II site, the company response);

• Response of companies can mean more or less impact;

• Companies differ and the costs of compliance will vary significantly;

• Changes in protection level are very difficult to estimate.

All these factors mean that the assessment of impacts will be more qualitative

than quantitative and that specific differences across Member States and indus-

tries cannot be identified.

3.3 Derogation rule and safety clause

This impact assessment is focused on the impacts of changes to Annex 1. There

are however potential changes to the main body of the directive that would im-

pact on the assessments of the effect of the CLP on Annex 1. In it is current

version the Directive does only include a derogation rule with a narrow scope.

It allows for reduced requirements regarding the safety report.

It is not part of this impact assessment to consider how an amended derogation

rule could be defined20. Introduction of such a rule would however impact on

the translation of Annex 1 and the effect of the translation and therefore a brief

discussion of amending the derogation rule has been included.

The effects of the transition to the CLP and also the effects of REACH are dif-

ficult to predict. There could be reclassifications that will give rise undesirable

scope change in the Seveso II Directive. Hence, additional flexibility in the way

Annex 1 is applied could be useful. This could be relevant to have the option of

excluding activities or establishments where there is no major accident hazard

potential as well as having the option of including activities or establishments

where such a potential exists even though the classification categories do not

require it.

An amended derogation rule could be a provision to reduce the requirement for

establishments within scope or it could provide for a complete exclusion. For

the further assessment within this impact assessment, it is assumed that if an

amended derogation rule is put into place then it will allow for excluding estab-

lishments from coming into scope based on set of criteria. To provide for sym-

metric treatment of increase and decrease in scope, an amended derogation rule

20 Revisions to the Directive will be subject to a separate impact assessment.



should be accompanied by safeguard clause that would provide for including

establishments based on the same set of criteria.

The criteria would have to be developed though the starting point could be the

existing criteria for dispensations. They include references to physical form of

the substance, containment, location and quantities.

The use of an amended derogation rule and the corresponding safeguard clause

would require that Annex 1 would become subject to the Comitology proce-

dure. The effort on the part of the Member States and the Commission in rela-

tion to applying a derogation rule/safeguard clause is difficult to estimate.

These provisions are supposed to be used either to prevent unnecessary in-

creases or scope or unwanted reductions in protection levels. In either case they

will be used to prevent additional costs to either industry or society. There is a

likely to be a net benefit of applying these provisions.

Under the relevant hazard categories where the derogation rule or safety clause

is expected to be most relevant, there are specific discussions of how they will

impacts on the choice of alignment options.

3.4 Costs estimates related to Seveso II and to revisions of Annex 1

This section presents a number of estimates of the costs of Seveso II implemen-

tation and compliance.

Assessing the costs related to Seveso II poses a number of difficulties:

• Other health and safety legislation have overlapping requirements, and

some of activities to comply with the Seveso II might have been taken as a

result of such other legislation;

• There are wide variations between sites in the complexity of achieving

compliance;

• The implementation of Seveso II differs across Member States both in the

administrative process as well as in term of scope; and

• Companies might be able to adjust stocks of the Seveso II-relevant chemi-

cals to avoid falling within the scope of the Directive.

The last point relates to the avoidance activities and the costs of such activities

will generally not be estimated. If there is a change in scope, the costs related to

the administration and compliance will be estimated. Companies are assumed

to avoid coming into scope if that is less costly than coming into scope.



3.4.1 Costs of Adapting Annex 1 of Seveso II to CLP

Introduction of CLP will mean that companies will have to review the sub-

stances they use with regard to possible re-classification and re-labelling.

The impact assessment of the CLP21 has considered the possible one-off costs

that the transition to the GHS based CLP legislation will imply. The costs that

were quantified added up around 500 million EUR with some variation depend-

ing of the length of the transition period.

If the companies will include the necessary revisions regarding the new Seveso

Directive as part of transition process to CLP, the one-off costs caused specifi-

cally by the Seveso revision could be minimised.

In most cases, both companies and CAs will have to spend some time on re-

viewing the amendments to the Seveso II Directive to determine if these have

any impact on their status or the enforcement of the directive.

The costs of such reviews are difficult to estimate. Only purely illustrative cal-

culations can be used with the following assumptions:

• Each company spend one to three days on reviewing the substance and

mixture inventories (average 1.5 days) in addition to the CLP motivated

reviews;

• The number of non-Seveso II establishments that need make reviews in

order to determine if they might fall within scope is assumed to be 50% of

the number of Seveso II establishments;

• The total number of Seveso II establishments is approximately 9725 that

will need to review their inventories;

• An average annual day costs is assumed to be EUR 35022.

Using these assumptions, a rough estimate would suggest one off costs off

modifying the directive to be around EUR 7.6 million for industry. Assuming

that this one off costs is annualised over 5 years at 4%, the annual costs are

around EUR 1.7 million. Compared to the CLP transition costs, this is a rela-

tively small amount.

It is more difficult to estimate how much time each CA will use on such a one-

off review of the implications of the changes to the directive. Using the follow-

ing assumptions a rough estimate can be made:

21 COM(2007) 355 final] [SEC(2007) 853

22 Average annual gross earning in EU27 was EUR 31300 in 2006 based on Eurostat data.

It is assumed that there are about 235 working days per year, an overhead factor of 25%.

This gives a day rate of EUR 166. This work will be done by specialists with much higher

salaries. This is assumed to be at least twice and rounding the number, 350 per day is used.

CLP means review

of substances

One-off review for

all companies

One-off review for

all CAs



• Each MS would spend about 50 days to review the necessary changes to

the national implementation;

• The CAs would then use one day to review site-specific Seveso II permits

for 40% of all Seveso II establishments (i.e. about 3900);


This will result in a one off cost of about EUR 1.8 million.

The effort that the transition to the CLP legislation will imply could possibly be

reduced if more tools were available. Harmonised translation tables or even

electronic translation tools would reduce the administrative costs. They would

not include all the self classified substances but still could be a useful measure

to reduce the administrative burden.

Compliance costs Costs of compliance include:

• Costs to establishments (divided on initial cost and recurring cost);

• Cost to competent authorities (administrative costs - measured in time us-

age (days).

Our assessment has identified the following studies that include relevant infor-

mation and data regarding the cost of becoming and being a Seveso II. Sources

on cost information include:

• EU-VRi (2008) Study of the effectiveness of the Seveso II Directive,

August 2008;

• UK (2005) Regulatory Impact Assessment (final) of Seveso II;

• Nutek (2006) Näringslivets administrativa kostnader på miljöområdet; and

• The estimates presented by FEA at the 4th TWG meeting;

• Administrative burden study23.

In particular, a new study from EU-VRi (2008) presents estimates of the costs

to industry based on a survey. Estimates here suggest that costs for the safety

report are 'less than 10 person months' for the major part of the respondents

(62%). On average, the financial costs of the safety report ranges from EUR 20-

50 k 24. Implementation of the safety management systems are for the major

part of respondents (75%) estimated to 'less than 10 person months', the same

23 FINAL REPORT (2009) Measurement data and analysisas specified in the specific con-

tracts 5&6 on Modules 3&4under the Framework Contract n° ENTR/06/61Report on the

Environment Priority Area, EU PROJECT ON BASELINE MEASUREMENT AND

REDUCTION OF ADMINISTRATIVE COSTS. 24 EU-VRi (2008) Study of the effectiveness of the SEVESO II Directive, August, pp.46-47



goes for the costs of emergency plans (81% of respondents). The major part of

Competent Authorities (77%) did not have estimates on costs of administration.

A general observation was that approximately half of the respondents have not

estimated the costs of the Seveso II implementation.

A study of the English COMAH estimate 'costs to business …' of the existing

Seveso II requirements at GBP 42,000 (excl. control costs (present value over

appraisal period; incl. control costs equals GBP 160,000). An appraisal period

of five years (after which the safety report must be renewed), makes yearly

costs at GBP 11,070, which equals roughly EUR 13,179. These numbers are for

the lower tier of the COMAH - upper tier estimates range at GBP 255-268,000

(GBP 376,000 incl. control costs). The average GBP 261 500 translated into

Euro per year equals EUR 62,256. Non-recoverable costs to the competent Au-

thorities are estimated at GBP 1.5-1.6 million per year, and costs to local au-

thorities are estimated at GBP 9-37,900 per site over the appraisal period25.

A Nutek study (2006) estimates the total costs of implementing Seveso II in

Sweden at SEK 2,203,44026. The report divides the costs on population and to-

tal hours. Although, the study does not reveal the number of establishments in

Sweden, each cost of documentation demand can be divided by the population,

and subsequently summarised on the different types of documentation. The cal-

culation estimates cost per establishment ranging from SEK 13,350 to SEK

239,972, this equals EUR 1,298 - 23,328.

In sum, these three brief examples present an administrative compliance costs

ranging from EUR 1,298 - 13,179 for the lower tier and EUR 23,328 - 62,256

for the upper tier per year.

The FEA cost estimates are based on data from the survey conducted by Atkins

on behalf of the FEA. It should, however, be noted that estimates appear to be

somewhat high. The costs of an establishment (not manufacturing) included in

the Seveso II are displayed in the following table.

Table 3-1 Industry estimate of Seveso II costs (Estimates by FEA)

Lower tier Upper tier

Duty holder initial costs 197,000 568,000

Competent authority costs

(first five years)

10,000 61,000

Duty holder ongoing costs

(first five years)

30,000 183,000

Total costs 237,000 812,000

Total annual costs 50,000 180,000

Source: Atkins 2009 on behalf of FEA

25 UK (2005) Regulatory Impact Assessment (final) of SEVESO II

26 Nutek (2006) Näringslivets administrativa kostnader på miljöområdet



As the table displays, the costs of becoming a Seveso II establishment is EUR

227,000 including the initial costs and current expenses. In addition, the costs

to the competent authority are EUR 10,000 over five years. For the upper tier

establishments are about three times higher, at EUR 751,000 for the establish-

ments (including ongoing costs for five years), and EUR 61,000 for the Compe-

tent Authority over five years.

In January 2007, the EC launched an Action Programme to reduce the adminis-

trative burdens in the EU with a focus on the administrative cost from EU legis-

lation. The Programme has 13 priority areas of which one is the environment.

Within environment the Seveso II is one of the Directives selected for particu-

lar attention.27 The study has estimated that the Seveso II has a yearly adminis-

trative cost of EUR 52 million in total28.

The study has covered the following main activities:

• Written update of safety report (one every five years)

• Written update of internal emergency plan (updated every three years)

• Cooperation with inspectors (frequency not indicated)

• Notification of presence or changes in presence of dangerous substances

(5-10% of establishments every year)

Based on estimates of the time spend for each activity, the hourly salary for the

relevant staff, consultancy support, and the number of occurrences, the total

costs for each activity have been estimated. Update of safety reports is most

expensive at 19.7 million per year. The cost per establishment is therefore

around 22,000 EUR. Updating of internal emergency plans is estimated to costs

13.9 million EUR. With the occurrence of once every three years, the cost per

establishment is around 9,300 EUR. The estimated notification cost is around

8.1 million EUR and that is approximately 11,000 EUR per establishment.

Updating of safety reports and emergency plans are required by upper tier only

while notification is for all Seveso establishments. Using these data to estimate

the costs of the new establishment entering scope of Seveso II means that the

costs for a lower tier establishment will be around 11,000 EUR while the costs

for an upper tier will be around 42,000 EUR. Annualising these initial costs, the

lower tier establishment will have annual costs of 2,200 EUR while the cost for

upper tier establishments can be estimated to 10,400 EUR.

These costs are for update of plans etc and there less than what a company will

face first time it become within the scope of the Seveso II Directive.

27 http://ec.europa.eu/enterprise/policies/better-regulation/administrative-burdens/action-

programme/index_en.htm 28 Conclusions of a DG ENTR study as part of the Commission's programme of reducing

the administrative burdens of EU legislation (which included the Seveso II Directive) 2009

Administrative bur-

den study



Summary of costs The best estimate is the average of the identified sources (except the high

industry estimate); the low estimate is 50 per cent of the best estimate, while

the high estimate is three times higher.

The cost estimates includes only the administrative costs for industry. The ex-

tent to which companies will need to invest in protection measures and reorgan-

ising of storage facilities etc is not known. Therefore costs could be higher for

new establishments entering the scope of the directive. In general, the costs of

both safety plans and physical measures depend on whether safety management

systems already existing due to other types of legislation for example protection

of workers. However, the estimates presented here are the best available esti-

mates of the Seveso costs.

For upper tier establishments, the developing and updating the safety report is

the main cost component. This study assume the below average costs for upper

tier establishments. In case that scope is changed and more substances will be

included, the cost of the preparing or updating the safety report is likely to in-

crease. This effect has not been explicitly included as it is difficult to estimate

the exact impact on costs also considering the overall broad range of estimates

used to assess economic impacts29.

Table 3-2 Overview of cost estimates in '000 EUR per year

Source Lower tier Upper tier

EU-VRi (2008) 20-50 for safety report

UK (200x) 13 60

Nutek (2006) 1.3 23

FEA (2009) 50 180

Administrative Burden study (2009)1 2 10

Average used in IA 5-30 25-150

Low 2 15

Best 5 30

High 15 100

Note 1) This is for updates of reports and plans

Swedish establishments appear to have a comparatively lower cost compared to

the UK. Many reasons could pertain to this such as different ways of imple-

mentation or differences in method of estimating the costs. In general, the

safety reports were estimated to cost from EUR 20 to 50,000. These data pro-

29 The study assumes that an increased number of substances included under scope leads to

more establishments being covered. This might not always be the case instead the costs for

those already Seveso sites might increase leading to the same overall economic impact as

what follows from the applied assumption of more substances resulting in more establish-

ments.

Differences in cost

estimates



vide an initial insight into some of the costs that pertain to the implementation

of Seveso II, as well as some of the differences that accrue due to the Directive

and its implementation.

The EU-VRI report observes that the majority of respondents recognise that

Seveso II implementation differs greatly across borders, and even within a

given country (EU-VRI, p. 9). Some countries use second opinions to add to

the operators' assessment - in some cases this is a requirement (Spain), in other

cases a second opinion can be requested by the Authority (France, and in some

cases third parties are hired to make the actual inspections (Germany). Finally,

some have no such system of second opinion (Sweden). In al cases, the costs

are borne by the operator, however, based on the differences in implementation

costs will also differ across borders.

There are some data on country-specific costs from the Administrative Burden

study. They have based the cost estimation on data from six Member States

(CZ, FR, IT, LV, SK and ES). The country specific data show that there are

differences in the time estimate for the different requirements and the unit costs

(salary level) vary across Member States. There is a factor of up to 10 in the

unit costs while the time spend varies by a factor 2.

The majority of the costs of Seveso II compliance are man-hour costs. They

will vary with the price level in each Member State. It means that the relative

burden is likely to be of the same order of magnitude across MS measures as

costs per GDP.

Avoidance costs The costs to industry of avoiding being covered by an increased scope is more

difficult to estimate. It has not been possible to estimate these costs. Instead the

following argument is applied: If a company chooses to avoid being covered by

the directive, then it must be because it is cheaper than compliance. The esti-

mate of compliance costs is therefore an upper boundary for the estimate of

avoiding coverage by redefining activities.

Cost differences be-

tween MSs



4 Impact assessment of translation of physical hazards

4.1 Overall assessment of physical hazards translation

The translation of the Annex 1 categories for physical hazards into the CLP leg-

islation is generally characterised by one-to-one translations. Overall, there are

mainly technical issues related to the testing and characterisation of the hazards

involved in the translation of the physical hazards more than issues related to

differences in classification criteria and overlapping hazard categories in the

DSD/DPD and the CLP. Some of the issues are:

• Flammable liquids: This category includes liquids with a flashpoint of

60°C or less. The DSD/DPD includes three categories (extremely flamma-ble, highly flammable and flammable liquids). The limiting flashpoint cri-

teria for the different categories are not completely identical and may po-

tentially result in an increase in the scope for substances with a flashpoint

close to the limit for flammable substances in DSD and DPD (55°C). In addition to that Seveso II includes some notes on highly flammable liquids

(e.g. substances with R17)30 and extremely flammable gases and liquids.

• Flammable aerosols: New category and potential change in scope. This is

analysed separately below. Aerosols are any non-refillable receptacles con-

taining a gas compressed, liquefied or dissolved under pressure, with or

without a liquid, paste or powder, and fitted with a release device allowing

the contents to be ejected as solid or liquid particles in suspension in a gas,

as a foam, paste or powder or in a liquid state or in a gaseous state. Cur-

rently aerosol containers are for Seveso II purposes considered as having

two substances - the propellant and the contents. -the aggregation rule for

propellant and other components respectively applies. CLP introduces the

new classification category for flammable aerosols: Categories 1 and 2

based on test methods already used for aerosols.

• Self-reactive substances and mixtures and organic peroxides: Self-reactive

substances or mixtures are thermally unstable liquid or solid substances or

mixtures liable to undergo a strongly exothermic decomposition even

30 R17: Spontaneously flammable in air.



without participation of oxygen. They represent a new separate hazard

class in CLP and are tested and classified based on the same criteria as or-

ganic peroxides in both CLP and according to dangerous goods regulations

and are represent the same risk in a Seveso II context. In the DSD/DPD,

they may be assigned different R-phrases including R231, R332. In the CLP

they are divided in Type A-F substances. Type A and Type B substances

are assigned R2 or R3 in the DSD and some type C substances are as-

signed R2 as well. Organic peroxides Type C-F currently classified O;

R733 fall into CLP organic peroxides with an expected decrease in scope

for particularly Type C.

• Pyrophoric solids: This category has been discussed a new separate CLP

category which is described in section 4.3.1.

• Oxidising solids: These are solid substances or mixtures which, which

alone are not necessarily combustible, but may, generally by yielding oxy-

gen, cause or contribute to, the combustion of other material. The DSD

classification with risk phrases R8 or R9)34 comprise almost the same sub-

stances as the CLP class Oxidising solids. In the CLP, this hazard class has

three categories and depending on whether category 3 is included, the

scope may either increase or decrease slightly primarily because of differ-

ences in test methods applied to oxidising solids.

All other categories of physical hazards are not considered to cause any notable

changes in scope and therefore no specific impact assessment is done for these

other categories. In the Draft Interim report from the technical Working Group

on Seveso and GHS from April 2009, the Appendix includes the proposal (as of

April 2009 after TWG 4) for the Annex I part 2 for physical hazards. For each

hazard category in column 1, information explaining the entries and how they

were derived is included in a separate "motivation" column. For the physical

hazards not mentioned above, the motivations can be summarised as follows:

• Explosives: The current entries are already harmonised with CLP through

the ADR-classification (Classification of Dangerous Goods by Road) ex-

cept for unstable explosives which are covered under Seveso II, but may

not be transported and therefore are not included in ADR.

• Oxidising gases represent a straight translation from O; R8 in DSD to Oxi-

dising gases Category 1.

• Oxidising liquids represent a straight translation from O; R8 and O; R9 in

DSD to Oxidising Liquids Category 1, 2 and 3 in CLP.

31 R2: Risk of explosion by shock, friction, fire or other sources of ignition.

32 R3: Extreme risk of explosion by shock, friction, fire or other sources of ignition.

33 R7: May cause fire.

34 R8: Contact with combustible material may cause fire. R9: Explosive when mixed with

combustible material.



• Flammable gases represent a straight translation for Note 3(c) (2) in the

current Annex I Part 2. Gases classified with Fx; R12 in DSD correspond

to Flammable Gases Category 1 and 2 in CLP.

• Pyrophoric liquids represent a straight translation for the first indent of the

current Note 3(b)(1), since the classification F;R1735 corresponds directly

to Pyrophoric Liquids Category 1.

4.2 Specific impact assessment of flammable aerosols

4.2.1 Alternative translations

Currently aerosols are classified for Seveso II purposes based on the flammable

propellant and other flammable components respectively and compared to the

related thresholds. CLP introduces the new hazard class for flammable aero-

sols, Categories 1 and 2 based on test methods already used for aerosols.

The issues in relation to the classification of aerosols are:

• Should the treatment of aerosols be changed using that CLP introduces a

new hazard class or should the existing approach using the aggregation

rule be maintained?

• Should the Category 1 and 2 from the CLP be used or should the entries

for aerosols by based on whether the propellant is a flammable gas or not;

and

• What should be the thresholds for aerosols and should they be based on

actual contents of flammables or on average content?

New aerosol category Given that current situation regarding how aerosols are treated is not too clear

and the fact that aerosols in the future will be classified using the new CLP

categories, this suggests that the new categories should be used and a specific

aerosol category should be introduced.

There are then alternative options for how that could be done. Firstly, with re-

spect to the issue of using the CLP Category 1 and Category 2, it should be

noted that the CLP classification criteria for placing aerosols in either Category

1 or Category 2 are based on tests that are not conceptually relevant to the risk

in a Seveso II context but rather to the end-user.

More importantly, defining the aerosol entry based on CLP Category 1 and 2

classifications is not considered workable due to lack of information. If ware-

houses store flammable aerosols for consumers without a safety data sheet, in-

35 R17: Spontaneously flammable in air

CLP Category 1

and Category 2



formation on Category 1 and 2 is not available in the warehouse databases,

moreover, the transport documents do not provide the information.36

Instead the new aerosol entries should be based on a distinction between flam-

mable aerosols with or without flammable propellant, which is relevant in a

Seveso II context. It should be noted however, that this presupposes that infor-

mation about the propellant is available, but this is not always communicated in

the supply chain for consumer products. It is still considered the most workable

option for defining aerosol categories.

The next issue is to determine the relevant thresholds. They could be based on

the actual or an average content of flammable gas. Using the actual content

would imply a treatment of aerosols very close the current situation. The diffi-

culty is the lack of the appropriate information in some situations as mentioned

above. This information is not always available, making it difficult for any es-

tablishment to estimate the qualifying amount of flammables. In favour of this

option is that it will maintain current scope.

Using the thresholds for LPG of 50 and 200 tons that are the current qualifying

quantities for the flammables content would lead to a significant increase in

scope37. A proposal for the thresholds has been developed based on an assump-

tion of about 38 per cent flammable gas in an average canister38. Combined

with thresholds for LPG, the resulting thresholds are 150 and 500 tonnes with

flammable propellant and 5000/50000 tonnes with non-flammable propellant.

To sum up regarding the treatment of aerosols the following alternative options

should be considered:

• Continue with the current treatment of aerosols based on content of flam-

mables

• Introduce aerosol entries for flammable aerosols with flammable and non-

flammable gasses respectively based on actual content of flammables

• Introduce aerosol entries for flammable aerosols with flammable and non-

flammable gasses respectively based on average content of flammables

• Introduce aerosol entries for flammable aerosols based on CLP categories

1 and 2.

The next section includes an initial assessment of these main alternatives to de-

termine which alternatives should be further included and subject to the impact

assessment.

36 This is based on judgements from the TWG where both MS and industry representative

agreed on that this information is not available and the Category 1 and 2 distinction would

not be workable. 37 Assessment made by HSE (2009) in FLAMMABLE AEROSOL CANISTERS –

A UK discussion paper for the 5th Technical Working Group (TWG) meeting. 38 Analysis mad e by FEA as input to the TWG.

Flammable/

non-flammable

Actual or average

content of flamma-

bles



4.2.2 Initial assessment of alternatives options for aerosols

The starting point for the initial assessment is to consider whether an alternative

is implementable in practice, i.e. administrative feasible. Secondly, the aim of

the translation is to maintain current scope and therefore alternatives should be

evaluated in terms of whether they will maintain the current scope. Thirdly, us-

ing the categories and classifications offered by the CLP could be considered as

an advantages..

Assessment of the impact on scope might require a quantitative assessment so

the screening is based on a qualitatively assessment of the potential impact on

scope.

Table 4-1 Initial assessment of alternatives for aerosols

Administrative

feasible

Maintain

current scope

Use the CLP

classifications

Continue with the current treatment of

aerosols based on content of flamma-

bles

(No) Yes No

Introduce aerosol entries for aerosols

with flammable and non-flammable

gasses based on actual content of

flammables

No Yes Yes


with flammable and non-flammable

gasses based on average content of

flammables

Yes Yes? Yes


based on CLP categories 1 and 2

No Yes? Yes

Given that administrative feasibility is a precondition for the option to be ap-

plied, there is only one alternative that is relevant to consider further.

Preferred option The impact assessment will consider the alternative based on the average

content of flammable gases as the preferred option.



Table 4-2 Suggested translation for aerosols

Category Articles 6 & 7 Article 9

FLAMMABLE AEROSOLS *"Extremely flammable" or "Flamma-

ble" aerosols, containing flammable gases] 150 tonnes 500 tonnes

FLAMMABLE AEROSOLS *

"Extremely flammable" or "Flammable" aerosols not containing

flammable gases nor flammable liquids category 1]

5000 tonnes 50000 tonnes

* The legal wording still needs improvement. The classification needs to refer to the Aerosol Dispensers Directive

75./324/EEC in order to cover all aerosol products.

4.2.3 Identification of the impacts of preferred alternative

The key question to address in the assessment of the preferred alternative for

dealing with aerosols is whether it will lead to a change in scope or regulatory

attention.

The assessment is primarily based various data and information. There are two

surveys on the impact of the preference alternative. The FEA and the Ministère

de l'Ecologie, de l'Energie, du Développement durable et de la Mer have both

investigated the issue. The results of these investigations are shown below.

The Health and Safety Executive in the UK has also assessed the impact39.

Their review shows that a few establishments would move from lower to upper

tier and a few currently not in scope could become lower tier. This assessment

is however based on data for actual LPG content and an assumed total weight

of the canisters. It is therefore less useful for the impact assessment. Further-

more, the Netherlands have made an assessment which shows that analysed op-

tion will have limited impact on scope.

FEA survey of impact

The assessment conducted by the FEA is focused on the 150/500 tonnes

thresholds as a single category as this is the entry that will impact on the num-

ber of establishments.

Survey approach The FEA has made a survey of 90 establishments in the aerosol industry. This

means that 17 per cent of the industry is represented. It is not possible to make

an assessment of the representativeness of the sample.

The baseline for making this assessment is the current situation, and it is dis-

played in the table below.

39 HSE (2009) FLAMMABLE AEROSOL CANISTERS –

A UK discussion paper for the 5th Technical Working Group (TWG) meeting



Table 4-3 Description of FEA sample of establishments

Baseline - situation today

Not Seveso II Seveso II site,

lower tier

Seveso II site,

upper tier

Number of manufacturing sites

(including warehouses on manu-

facturing sites)

17 20 9

Number of warehouses (outside

manufacturing plants)

24 14 6

Total 41 34 15

Source: FEA 2009

Results The companies were asked to indicate whether they were above any of the

thresholds given the definition, and the findings are shown in the below table.

Table 4-4 Impact of aerosol option

Assessment of option with threshold 150/500

Not Seveso II Seveso II site,

lower tier

Seveso II site,

upper tier

Number of manufacturing sites

(including warehouse on manu-

facturing sites)

18 15 13

Number of warehouses (outside

manufacturing plants)

21 16 7

Total 39 31 20

Source: FEA 2009

A comparison of the current situation with the option with thresholds 150/500

tonnes for flammable aerosols shows some changes in the Seveso II status of

relevant sites (aerosol industry sites only). The percentage changes are dis-

played below.

Table 4-5 Change in number of Seveso sites with option expressed as a percent-

age

Changes in Seveso II sites

Lower tier manufacturing sites 25% decrease (lower tier � upper tier)

Lower tier warehouses 14% increase

Upper tier manufacturing sites 44% increase

Upper tier warehouses 17% increase

Source: FEA 2009

Any change in Seveso status is more critical for warehouses than for manufac-

turing sites. There is an increase of around 15 for warehouses, while for manu-



facturing sites the change is in regulatory attention where sites move from

lower to upper tier. The total impact in terms of number of sites being covered

by Seveso II is limited - there is an increase at around 5%.

In order to extrapolate the survey result to the whole of EU a set of assumptions

have to be applied.

The European aerosol industry is assumed to comprise 500 companies (ranging

from SMEs to multinationals) in 18 countries. There are no data on EU ware-

houses outside the industry with significant storage of aerosols. The second as-

sumption is that the distribution of warehouse and manufacturing sites in the

surveys can be applied to the 500 establishments in the European industry. This

means that it is possible to combine the results, and this paves the way for an

overall assessment of the European aerosol industry.

The table displays the distribution of establishments under the current situation

and with the preferred alternative.

Table 4-6 Scaling of survey results for warehouses

Current situation Preferred option Difference

Lower tier 90 103 13

Upper tier 40 46 6

Not Seveso II 120 101 -19

Total ~250 ~250 0

The above result assumes that the change is most critical to warehouses - in

contrast to the manufacturing sites where the survey indicates a change in regu-

latory attention so more lower tier sites become upper tier but no change in the

total number covered by the directive.

French survey of impact

The French ministry Ministère de l'Ecologie, de l'Energie, du Développement

durable et de la Mer has undertaken an assessment of the implication of the

aerosol option.

Survey approach The survey is based on:

• A list of establishments producing or storing aerosols including establish-

ments classified as Seveso sites because they are below thresholds. The list

includes 47 establishments

• Information based on safety reports, inspectors' knowledge and specific

inquiries

• Data on the actual content of flammable propellant.

Scaling of the as-

sessment



Results The survey results are summarised in the table below.

Table 4-7 Results of survey on French aerosol establishments

Today Alignment situation

Not Seveso II Lower tier Upper tier Total today

Not Seveso 12 0 0 12

Lower tier 2 15 3 20

Upper tier 0 4 11 15

Total with align-

ment option

14 19 14 47

Source: Ministère de l'Ecologie, de l'Energie, du Développement durable et de la Mer

This survey found that there will be a slight reduction in scope in terms of

number of lower and upper tier establishments. Lower tier will be reduced from

20 to 19 establishments while upper tier establishments will be reduced from 15

to 14.

Overall assessment of impact on scope

The two surveys give slightly different results. One suggests a small decrease in

scope while the other suggests small increase in scope. The French survey does

not distinguish between manufacturing and storing sites so it is not possible to

see the difference in impact on either type. The French survey is better docu-

mented with respect to estimation of the impacts.

Overall, using these surveys as indicators of the likely impact on scope that fol-

lows from the preferred alignment option/alternative suggests limited changes;

though a small increase in the number of establishments within scope can not

be ruled out.

4.2.4 Protection level considerations

The question about impact on protect levels is about whether aerosol cans in

large quantities may lead to disaster and foster rapid fire development that pre-

sents a major hazard to the emergency response crew and is capable of project-

ing hazards into surrounding areas. Additional concerns include toxic smoke,

polluted fire water and generation projectile hazards.

Cons Arguments against aerosols constitute major accident potentials:

4 The major con is that a large quantity of LPG stored in many small pres-

surized containers does not present the same hazard as the same quantity

stored in a single large pressure vessel. Most notably, a catastrophic pres-

sure vessel failure and instantaneous violent release of the entire inventory

(large BLEVE) cannot realistically be assumed to take place. Also, the po-

tential for large gas releases with late ignition, leading to flash fires several

hundreds of meters from the point of release is not conceivable. The cur-

rent lower-tier threshold for LPG is 50 tonnes. The very substantial haz-



ards for a 49 tonnes single LPG storage vessel, which would require an

evacuation zone of at least 500 m and is currently outside the scope of

Seveso II, are therefore not comparable to even larger inventories stored in

aerosol cans. Additionally, standard fire control regulation in most, if not

all, countries would mandate that such aerosol storage was compartmental-

ized in fire cells designed to prohibit entire inventory from being con-

sumed in a single event. The implication would be that if a bulk 49.9 ton-

nes LPG vessel is deemed out of scope in the existing Seveso l II legisla-

tion, then any aerosol storage inventory would be out of scope.

5 The emission of toxic smoke is not a property usually attributed to fires

involving LPG; as such fires due to efficient combustion (giving rise to

high thermal radiation intensities) do not generate much smoke. The toxic

smoke is likely to originate from simultaneous combustion of materials

other than LPG - i.e. the toxic smoke hazard originates in the combustion

of those other substances, not the LPG, which could be considered a trig-

ger only (along with many other potential triggers).

6 The generation of large quantities of polluted fire water is not related to

LPG, which due to its gaseous state at ambient conditions cannot pollute

fire water. The source of polluted fire water is the incomplete combustion

of other materials and wash-out of unburnt substances, harmful to the envi-

ronment. As with the smoke, LPG can be considered a trigger, only one

out of several, but not the source of the hazard itself.

7 Reports exist that an aerosol can projectile a hazard up to several hundreds

of meters, but projections are generally below 100 meters. While serious,

the hazard is incomparable to bulk storage. A cylinder type LPG bulk stor-

age tank is reported to have travelled 1,200 m in the 1984 Mexico City dis-

aster.

Pros Arguments for aerosol constituting a major accident potential:

1 As the French empirical review demonstrates, large inventories of aerosol

cans do present a "major hazard" potential, as defined in the Seveso II Di-

rective. It has not been possible to review whether such accidents pre-

dominately have happened at sites with manufacturing activities or also at

pure storage sites.

2 LPG as a named substance is already subjected to special terms (i.e. a

lower level of protection for the general public). The thresholds for flam-

mable compressed gasses are 10/50 tonnes, while for LPG (also a flamma-

ble compressed gas) the thresholds are substantially higher; 50/200 tonnes.

This special provision seem to have arisen from an administrative/political

desire to limit the number of LPG bulk storage Seveso II establishment not

the number of LPG aerosol establishments

3 The present situation with aerosol cans using LPG as propellant containing

flammable solvents is slightly ambiguous. Should the LPG and solvent

contents of the can be accounted for separately, as LPG and highly flam-



mable liquid respectively, using the aggregation rule, or should the mixture

be classified as LPG (but not as a flammable compressed gas). This ambi-

guity is undesirable.

4 The LPG threshold quantities have remained unchanged since the first

Seveso II Directive was launched in the early 1980s. At that time, CFC

was frequently used as propellant in aerosols, as it was a non-flammable

substance., CFCs were then phased out following the implementation of

the 1989 Montreal protocol. The phase-out of CFCs was largely made pos-

sible by substitution with LPG. It may therefore be argued that large-scale

storage of aerosol cans with LPG propellant is a relatively recent develop-

ment not reflected by the Seveso II legislation.

5 As a result of the above, large-scale storage of aerosol cans may now exist

in residential or other sensitive areas. These storage facilities fall outside

the scope of the Seveso II legislation, and consequently outside the scope

of EU formal land use planning provisions and EU formal emergency re-

sponse and evacuation planning provisions.

4.2.5 Conclusion on aerosol translation

The analysis of aerosols revealed the following:

• An estimate of average LPG or flammable propellant content in aerosol

cans indicated a level around 38 per cent. This is used to convert the LPG

thresholds of 50/200 into aerosol thresholds of 150 and 500 tonnes.

• Surveys of the impact of the options with 150/500 based on total aerosol

quantity indicate either a small decrease or increase in scope.

• Some installations will fall outside the scope and some will fall within the

scope of the Seveso II Directive compared to the current situation.

• Overall, no major changes in scope are expected.



ard potential or not.

• Overall, it is concluded that the impact of the proposed translation will be

limited, though it can not be ruled out that new installations might fall

within the scope of Seveso II.



4.3 Other physical-chemical issues

4.3.1 Pyrophoric solids

Background With regard to physical hazards it has been agreed to assess the impact of

including pyrophoric solids in the scope of the Directive.

The list of 13 substances identified as pyrophoric solids in the MARS database

(Ineris, 2nd TWG) is used for the assessment.

Pyrophoric solids are solid substances or mixtures which, even in small quanti-

ties, may ignite within five minutes after contact with air. Test methods for this

substance category are identical in the DSD and CLP, but in the DSD/DPD,

pyrophoric solids and liquids are subsumed under the highly flammable cate-

gory and assigned risk phrase R17. Pyrophoric solids are not currently included

in Seveso II. In the CLP, they are classified in a single category based on a

similar test method as that used for R17.Under the transport of dangerous goods

rules, both solids and liquids are assigned packing group I (very dangerous sub-

stances).

Assessment 13 substances potentially classified as pyrophoric substances under the CLP

have been identified. Three of these substances are currently outside the Seveso

II scope whereas 10 have properties from one or more Seveso II entries. For 6

of the 10 substances, the regulatory attention will increase if thresholds similar

to pyrophoric liquids are applied for the solids (50 tonnes and 200 tonnes).

Because pyrophoric substances may pose a risk considered relevant in the

Seveso II context and because inclusion is not expected to have any significant

impact on industry, it has been suggested to include the solids together with the

pyrophoric liquids in the scope of Seveso II. Only a few substances are ex-

pected to be affected by the inclusion.

The alternatives are to either include pyrophoric solids as separate entry or to

leave them out as is the case today.

Table 4-8 Alternatives for pyrophoric solids

Advantage Disadvantages

Leave pyrophoric solids out as

today

Maintain current

scope

Less complete use

of CLP categories

May possibly cause

an accident

Include category on pyrophoric

solids with thresholds similar to

liquids.

Maybe small in-

crease in protection

level

Increase in scope

though not possible

quantify the impacts



Concerning pyrophoric substances, they may reasonably be considered efficient

sources of ignition, an initiator of fires even in small quantities, along with a

diverse range of other initiators. However, the effects are likely to be localised.

Whether a major-accident will result will depend on the presence of other sub-

stances with a major-hazard potential.



5 Impact assessment of options related health hazards

5.1 Issues in translation of health hazards

The translation of the health hazards is the area where the CLP categories devi-

ate most from the current classification criteria under DSD. It is not possible to

achieve a one to one translation and a number of options for alternative align-

ments need to be assessed.

Currently Seveso II operates with two categories for toxicity: T+ for very toxic

substance and T for toxic substances. The CLP introduces more categories;

acute toxicity Category 1 to Category 4 (called Acute 1, Acute 2, Acute 3 and

Acute 4). The first three are potentially relevant for Seveso II.

To help in understanding the differences a graphical presentation has been de-

veloped40 which illustrates the translation issues. The figure shows the bounda-

ries of the new Acute 1 to 4 compared to the existing T+ and T by exposure

route. It is based on the LD50 and LC50 values.

The grey dotted line represents the 1:1 translation from the EC classification

rules in the Directive 67/548/EEC and the GHS based rules implemented by the

CPL Regulation. It is therefore clear that the difficulty of translation is due

situations where:

• Acute 1 does not match T+ as for the oral and inhalation aerosol exposure

routes. 2

• Acute 2 (and Acute 3) do not match T as for the oral, dermal and inhala-

tion gas exposure routes.

The impact assessment is focused on defining and analysing alternative options

for how align the health categories of very toxic and toxic.

40 By Herbert Bender BASF and Zsuzsanna Gyenes JRC.



Figure 5-1 Illustration of difference between Seveso II health categories and the

CLP classifications


classifcations

T+ T XnEU

1 2 3 4Oral

mg/kg

1 2 3 4inhal.

vapour

mg/l

inhal.

aerosol

mg/l

1 2 3 4

2 3 4inhal. gas

mg/l

ppm

1 32 4Dermal

mg/kg

0 25 200

0 5 25 50 200 300

0

0,1

0

0

0

0,5

0,5 2 2.5

2

20050 400 1000

0,50,05 0,25 1

500 2000 25001000

10

Boundary

for old

legislation

1

Gyenes

The differences between exposure or uptake routes and the fact that for some

routes the alignment is straightforward have led to considerations of alignment

options that differentiates between exposure routes.

With regard to the classifications T+; R3941 and T; R39 of Directive

67/548/EEC it was decided by the TWG that these classifications should be

aligned with Category 1 of the CLP class Specific Target Organ Toxicity - Sin-

gle Exposure (STOT-SE). The proposed qualifying quantities are 50 and 200

tonnes for the lower and higher tier, respectively. This means that lower thresh-

olds will be assigned to those substances classified as T+ under the current

rules. These are however very few and only one such substance is included in

CLP Annex VI Table 3.2.

With regard to the classification T; R4842 (in combination with R-phase for up-

take route) it has been agreed to remove it from the scope of the Directive as it

has never been the intention to include health hazards from prolonged expo-

sure.

41 R39 is used in combination with exposure route, e.g.: R39/23: Toxic: danger of very

serious irreversible effects through inhalation or R39/26: Very Toxic: danger of very

serious irreversible effects through inhalation. 42 R48 is used in combination with exposure route, e.g.: Toxic: danger of serious damage to

health by prolonged exposure through inhalation



5.2 Defining relevant alignment options

The possible alignment options have been developed in the following way.

The starting point is the simple alignment options using the CLP health hazard

categories for acute toxicity to replace the T+ and T categories from the DSD.

The second step is then to consider more complex alignment options where

various mitigation options are applied to limit the changes to scope of the Di-

rective that would result from the simple alignments.

The impact assessment work has drawn on the work in TWG including sugges-

tions on options and estimates of the effect of options. The options set out here

are different from the ones developed by the TWG.

5.2.1 Simple alignments

These generic options can be combined in different ways. Based on the identi-

fication of the areas around the boundaries, the simple alignment options for

translation include the following options:

Simple alignment 1:

• For translation of T+: Acute 1;

• For translation of T: Acute 2;

Simple alignment 2:

• For translation of T+: Acute 1;

• For translation of T: Acute 2 + Acute 3;

Simple alignment 3:

• For translation of T+: Acute 1 + Acute 2;

• For translation of T: Acute 3;

The illustration at Figure 5-1 shows how the simple alignments potentially re-

sults in significant changes to the current scope of the Directive. The first of the

simple alignment options includes only Acute 2 for translation of T. This will

significantly reduce scope.

The second simple alignment option with T translated by Acute 2 and 3 will on

the other hand results in an increase in scope regarding T.

For both the two first simple alignments, the translation of T+ with Acute 1 im-

plies a reduction in scope; the third simple alignment will increase scope for

both the translation of T+ and T.



In order to avoid these changes to scope, a number of mitigation measures can

be used. They are discussed in turn in the following sections.

5.2.2 Differentiation by exposure routes

he differentiation by uptake or exposure means that the translation would vary

across the alternative exposure routes. As it can be seen from Figure 1.1, the

differentiation can not completely remove the changes to scope. For oral, der-

mal and inhalation through the gas route, the problem remains as excluding

Acute 3 means reduction in scope while including Acute 3 leads to an increase.

The drawback of the differentiation along the exposure routes is that informa-

tion on the Data Safety Sheet and/or product labels only covers the three main

routes oral, dermal and inhalation, while the sub-routes for inhalation will re-

quire more data.

Options that differentiate between exposure routes will deviate less from the

current scope compared to the simple alignment options. The additional admin-

istrative effort to apply the differentiation should be considered. Companies

will have to check if a substance is classified for more than one uptake route to

determine its status. Information on for example labels will typically give the

classification by exposure route but only for oral, dermal and inhalation. The

differentiation on the three sub-inhalation routes will require more information

so that companies will have to investigate each substance.

5.2.3 Named substances

Another way to avoid reductions in scope would be include more named sub-

stances in Annex 1. There is already a list of named substances in Annex 1 Part

1. These are mainly substances where certain specific conditions means that

thresholds different from the standard category was useful. Most notable, the

higher thresholds for petroleum products that prevent all gas/service stations to

be a Seveso site.

Using named substances could be useful way of preventing a reduced scope. In

particular in cases where there are only few substances and they can easily be

identified. The investigation has however identified serious drawback of the

approach using named substances to mitigate reductions in scope.

Disadvantages The main disadvantages include:

• The investigation has shown that it is difficult to identify a shortlist of sub-

stances that would have to be included if for example only Acute 2 is in-

cluded as T. The potential list is included in Table 5.3.

• The attempt to narrow down a short list with only the relevant substances

has not been successful and this approach seems to result in either that not

all substances will be covered or that the list will be very long including

also less relevant substances.

Three main exposure

routes

Sub-route for inhala-

tion

Advantages and dis-

advantages

Named substances in

Annex 1 Part 1



• Furthermore, using named substances means an unequal treatment of exist-

ing and new substances. A list of named substances can only be identified

from existing substances while new substances will be treated more fa-

vourable.

Options that include named substances to compensate for less inclusive

boundaries will deviate less from current scope than the alignment options

without named substances. Given the above listed disadvantages, this approach

seems less attractive and it is a only a second best approach to mitigate the pos-

sible scope changes.

5.2.4 Screening tool/decision tree

A third approach to mitigate the effect on scope would be to introduce a screen-

ing procedure. This could include criteria that would aim to maintain the cur-

rent scope. The screening should be included as part of Annex 1 and would

mean that for substances in category Acute 3, industry would have to assess the

LD50/LC50 values to determine whether the substance would be inside or out-

side scope.

The screening could be set up as either a screening in or a screening out proce-

dure. Screening in would be when for T only Acute 2 would be included as de-

fault and Acute 3 only included when the screening based on the LD50/LC50

would show that the substance should be in. Screening out would happened

when Acute 3 would included as default and substances would tested so deter-

mine if they should be excluded.

The advantage of this approach is that is possible to keep close to current scope,

but only for substances where the relevant LD/LC values are available.

The disadvantages of this option for mitigation scope changes include:

• The screening approach will discriminate between substances where the

relevant LD/LC values are available and those where they are not avail-

able. In the future, the classifications might no longer include the informa-

tion about the LD and LC values that are needed screen the substances. As

test will be guided to the new boundary values it might be difficult to de-

termine the status according the previous LD/LC boundary values.

• It will also require data collection and analysis on the side of the operators.

They would have to search for the relevant LD/LC values for all sub-

stances in Acute 3 and it is therefore a substantial additional effort that

would be required.



5.2.5 Derogation rule/safeguard clause

The derogation rule is described in Section 3.3.

In relation to the alignment options for the health hazards, a derogation rule

could work in way that in situation where it can be demonstrated that there are

not major accident hazard potential, a substance or an activity/industry can be

exempted fully or partly from the Seveso II requirements.

How that would affect the impacts of the alignment options depends on how the

derogation rule would be defined. If it would allow for full dispensation from

the Seveso II requirement then it could be used to maintain scope.

The derogation rule could be combined with the simple alignment option where

T is translated by Acute 2 and Acute 3. Then the rule would work somewhat

similar to the screening out procedure with main difference that only if there

would an increase in the number of establishments coming under scope, the

derogation process would be relevant. Inclusion of new substances will in many

cases not have any impacts as the companies using the substances are already

Seveso establishments.

The safety clause could be combined with another of the simple alignment. If

only Acute 2 was in to replace the T category, then the safeguard clause could

be applied to prevent this from reducing scope.

The option where the an alignment that includes both Acute 2 and 3 are com-

bined with derogation rule has the advantages that it will only initiate the ad-

ministrative procedure if it turns out there will be an increased number of estab-

lishments under scope with no major accident potential. Going the other way by

selecting a less demanding simple alignment, scope would be decreased and the

clause would then have to be applied.

5.2.6 Other options

In order to deal with the differences between the DSD and CLP classification

systems, the following generic alignment options can be defined:

• Alignment with cut-off points similar to T and T+ without any reference to

CLP.

• Alignments with decision tree approach

No reference to CLP An option with no reference to the CLP and using the cut-off points similar to

DSD categories of T+ and T would be quite similar to the screening approach.

It would require companies to investigate the LD50/LC50 values and therefore

be subject to the same disadvantages.

Decision tree approach An decision tree alignment options would include a ranking of the exposure

routes so that the determination of the status on given substance would start off

from one of the exposure routes for example inhalation gas. If classification



would be available, the next exposure route would be examined and so on. This

option is different in structure from the other options. The available data has

not allowed for any specific assessment of this option in terms of how it could

affect scope. The main disadvantages is that it requires the sub-exposure routes

to be applied and therefore it will have the same or higher administrative costs.

5.2.7 Assessment of boundary areas

The areas defined by the boundaries of the alignment options and the grey dot-

ted line representing the 1:1 translation are the areas relevant for the impact as-

sessment.

Figure 5-2 Overview of boundaries areas

3


classifcations

T+ T XnEU

1 2 3 4Oral

mg/kg

1 2 3 4inhal.

vapour

mg/l

inhal.

aerosol

mg/l

1 2 4

2 3 4inhal. gas

mg/l

ppm

1 32 4Dermal

mg/kg

0 25 200

0 5 25 50 200 300

0

0,1

0

0

0

0,5

0,5 2 2.5

2

20050 400 1000

0,50,05 0,25 1

500 2000 25001000

10

Boundary

for old

legislation

1

Gyenes

A1 A2

A5

A3

A7A6

A4

A2b

A8

A5b

In order to estimate the impact of alternative alignment options, for example the

effect of including Acute 3 oral exposure in the translation of T, it is important

to know which substances are in the area marked A2b. Below each of marked

areas are characterised.

Area 1 Only few substances are considered Seveso II-relevant in this area and it has

therefore been agreed to add relevant named substances with appropriate

thresholds to Annex I Part 1 in the amended Directive. The disadvantage of us-

ing the named substances approach is that substances with LD50's in this area

which become Seveso II-relevant in the future will follow higher thresholds.

This area will not be specifically addressed in the impact assessment as it is not

expected to be significant



Area 2 Area 2 represents a large number of substances and leaving them out of the

Directive would have a major impact on the scope of the Directive and the level

of protection.

Area 2b Area 2b representing the Acute Toxic 3 (oral) substances not currently covered

by the Directive also contains a relatively large group of substances and could

extend the scope of the Directive considerably. Implications of including Area

2b in the Directive is therefore an important focus for the impact assessment.

Area 3 Area 3 (Acute Toxic 3 (dermal) has not been found to contain many Seveso II-

relevant substances and could therefore be managed by named substances. Five

substances have been suggested for the Annex I Part 1.

Area 4 This area includes many substances and would result in an increased scope of

the directive. It is expected that a number of detergents would be relevant for

this area which could increase the scope of the Directive considerably.

Area 5 This area includes substances which could reduce the scope or regulatory

attention of the Directive if T+ is aligned with Acute Toxic 1 (inhalation aero-

sol) only. Inclusion of named substances is considered, though identifying a

short list of the most relevant substances has proved very difficult.

Area 5b This area includes substances which could increase the scope or regulatory

attention of the Directive if T+ is aligned with Acute Toxic 1 and 2 (inhalation

aerosol). However, it has not been possible to identify which substances of

relevance for industry are covered under this area (LC50: 0.25 - 0.5 mg/L).

Area 6 Gaseous substances are a particular problem in relation to alignment with GHS

classification criteria because GHS classifications are based on 4hr LC50's ex-

pressed as volume fraction (molecules per volume) whereas the EC classifica-

tion system uses mass fractions (mass per volume). Alignment therefore de-

pends on the molecular weight of the substance. It has been considered to in-

clude named substances to cover Area 6 and 7. Substances of significance have

been identified and suggested for Annex I part 1 in the Directive.

Area 7 The area includes only few substances which are not expected to have a major

impact on either scope or regulatory attention. It has therefore been considered

to include the full Acute Toxic 3 (inhalation gas) category in the Directive.

The importance of each area is measures by the number of substances belong-

ing to each area. Based on the gross list of harmonised classifications, the fol-

lowing number of substances has been identified.

Area 8 This area includes substances which could increase the scope or regulatory

attention of the Directive if T is aligned with Acute Toxic 2 and 3 (inhalation

vapour). Based on first preliminary assessment, the number could be significant

(potentially 50-100 substances). The industrial importance of those substances

is not known.



Table 5-1 Number of critical substance in areas

Area Number of substances in each area

A1 2

A2 22

A2b 48

A3 5

A4 95

A5 26

A5b 14

A6 6

A7 2

A8 Potentially significant number

Note: Some additional substances were identified by a member state ((A2 plus 7, A2b plus

1, A4 plus 2, A6 plus 6, and a7 plus 1 substance). These are displayed in the table 5.8 be-

low, with the remark 'not initially on list'.

Critical substances in Area A5b and Area 8 have not been identified as these

two areas were not included in the questionnaire to the Member States. Instead,

a preliminary check against the harmonised classifications in Table 3.2 in An-

nex VI of Regulation 1272/2008 provides the following information:

Area A5b: Without specific information about the physical form and the LC50

values for those substances assigned R23 (Toxic by inhalation), Area A5b can

not be separated from Acute Tox. Cat 3 substances listed in Annex VI. How-

ever, as a preliminary indication of the potential number of possible candidates

were filtered from the list using the R-phrase R23 as criterion. After that sub-

stances covered by other entries with similar or lower thresholds were filtered

out and finally substances covered by entries with higher thresholds were fil-

tered out with the following result:

Table 5-2 Substance from Table 3.2 in Annex VI of 1272/2008 in area A5b includ-

ing Acute Toxic 3 (inhalation)

Filter Number of substances

Substances assigned R23 and not T+ 188

Substances covered by other entries with similar or

higher thresholds filtered out

161

Substances covered by other entries with higher

thresholds filtered out

54

Substances specifically identified in A5b 14



Area A8: Without specific information about the physical form and the LC50

values for those substances assigned R20 (Harmful by inhalation), Area A8 can

not be separated from Acute Tox. Cat 4 substances listed in Annex VI. How-

ever, as a preliminary indication of the potential number of possible candidates

were filtered from the list using the R-phrase R20 as criterion. After that sub-

stances covered by other entries with similar or lower thresholds were filtered

out and finally substances covered by entries with higher thresholds were fil-

tered out with the following result:

Table 5-3 Substance from Table 3.2 in Annex VI of 1272/2008 in area A8 includ-

ing Acute Toxic 4 (inhalation)

Filter Number of substances

Substances assigned R20 243

Substances covered by other entries with similar or

higher thresholds filtered out

151

Substances covered by other entries with higher

thresholds filtered out

73

For A8 it is expected the most of the identified substances will fall outside the

area.

Based on this initial assessment of each of key areas around the boundaries be-

tween the existing and the new classification, a set of combined options have

been defined.

5.2.8 Selected options

A limited number of selected options have been defined combining the simple

alignment options, the result of the assessment of the alternative mitigation

measures and the semi-quantitative analysis of the boundary areas.

The four selected options cover most relevant combination of simple and more

complex alignment.

In principle the effects of the alignment options can be evaluated under differ-

ent scenarios. One is to assume that named substances is not applied for Option

B and C so there would be no compensation for reduced scope and alternatively

to assume that named substances are used to compensate for reductions in

scope. Similarly, the options can be evaluated with or without the derogation

rule/safeguard clause in place.

In the following they are referred to as IA Options A - D.

• Option A: Current scope using screening of Acute 2 and 3 for relevant ex-

posure routes;



• Option B: Acute 1 for T+ and possible named substances and Acute 2 for

T combined with possible named substances;

• Option C: Acute 1 for T+ and possible named substances and Acute 2 and

3 for T (except for dermal and inhalation vapour where only Acute 2 is in-

cluded);

• Option D Acute 1 for T+ and Acute 2 and 3 for T.

Table 5-4 Overview of alignment options for health hazards

Option T+ T Differentiated

exposure routes

Use named

substances

Use screening

tool

Option A Acute 1 Acute 2 Yes No Yes (Acute 2

for T+ and

Acute 3 for T)

Option B Acute 1 Acute 2 + Acute 3 (inhalation aerosol) Yes Yes No

Option C Acute 1 Acute 2 + Acute 3 (oral, inhalation aerosol

and gas)

Yes Yes No

Option D Acute 1 Acute 2 + Acute 3 No No No

IA Option A This option reflects an alignment using a screening tool and can be illustrated

as shown in Figure 4-2. This option basically preserves the current scope of the

directive.

Figure 5-3 Impact Assessment Option A (IA Option A)

IA option A

T+ T XnEU

1 2 3 4Oralmg/kg

1 2 3 4inhal.

vapourmg/l

inhal.

aerosol

mg/l

1 2 3 4

2 3 4inhal. gas

mg/l

ppm

1 32 4Dermal

mg/kg

0 25 200

0 5 25 50 200 300

0

0,1

0

0

0

0,5

0,5 2 2.5

2

20050 400 1000

0,50,05 0,25 1

500 2000 25001000

10

Boundary for old

legislation

1

Gyenes

A1 A2

A5

A3

A7A6

A4

A2b



Under this option, T+ translates into Acute Toxicity Category 1 for all exposure

routes, and T translates into Category 2. The screening tool is used to identify

substances in Areas A1, A2, A3, A5 and A6. This option allows for a total

alignment close to the present requirements. On the other hand, it will not be

easy to implement as potential Seveso II establishments will have to obtain in-

formation about the acute toxicity endpoints. The implications of this particular

information retrieval will be addresses in the impact assessment.

IA Option B This option reflects an alignment with Acute 2 and for inhalation aerosol also

with Acute 3. It deviates from the simple alignments by differentiation by ex-

posure route.

If the named substances approach is used, then there should be named

substances for Acute 3 with regard to the oral, dermal and gas exposure routes.

It is illustrated in Figure 5-4.

Figure 5-4 Impact Assessment Option B (IA Option B)

IA Option B

T+ T XnEU

1 2 3 4Oralmg/kg

1 2 3 4inhal.

vapourmg/l

inhal.

aerosol

mg/l

1 2 3 4

2 3 4inhal. gas

mg/l

ppm

1 32 4Dermal

mg/kg

0 25 200

0 5 25 50 200 300

0

0,1

0

0

0

0,5

0,5 2 2.5

2

2

0

0

50 400 1000

0,50,05 0,25 1

500 2000 25001000

10

Boundary

to old

legislation

1

Gyenes

A1 A2

A5

A3

A7A6

A4

A2b

T+ translates into Category 1 for all exposure routes. This option will result in a

decrease in the scope/regulatory attention represented by Area A2 and a reduc-

tion in scope/regulatory attention represented by Areas A3 and A6.

Mitigating the reduction in scope by using named substances will require a

considerable extension of Annex I Part 1.

IA Option C This option is similar to Option B in using the differentiated exposure routes.

The difference is that here Acute 3 is included for both the oral and the inhala-

tion gas exposure routes as illustrated in Figure 4-4. Option B and C are options

that take the simple alignments and add the differentiated exposure routes, ex-



cept for the dermal route as the analysis of the area A3, see Table 5-1, has

shown that it includes very few substances.

Figure 5-5 Impact Assessment Option C (IA Option C)

IA Option C and C*

T+ T XnEU

1 2 3 4Oral

mg/kg

1 2 3 4inhal.

vapour

mg/l

inhal.

aerosol

mg/l

1 2 3 4

2 3 4inhal. gas

mg/l

ppm

1 32 4Dermal

mg/kg

0 25 200

0 5 25 50 200 300

0

0,1

0

0

0

0,5

0,5 2 2.5

2

20050 400 1000

0,50,05 0,25 1

500 2000 25001000

10

Boundary

to old

legislation

1

A1 A2

A5

A3

A7A6

A4

A2b

This option will result in an increase in the scope/regulatory attention repre-

sented by Area A2b and Area A7.

Variation C* A variation to Option C, C*, is to include Acute Toxicity 2 for inhalation

aerosol in T+. For all the options, T+ has been translated with Acute 1 only.

The substances in area A1 and A5 are still included but now under T which has

different qualifying quantities. Variations marked * indicates that Acute 2 for

inhalation aerosols are included with T+ thresholds.

IA Option D This option reflects a precautionary alignment and is illustrated in Figure 4-5. It

includes Acute 2 and 3 for T and Acute 1 for T+.

This option represents a simple alignment with no differentiation by exposure

routes. This option represents an option that is easy to manage for industry as

no further information is required besides the label information.

It is therefore administratively more simple that Option A to C. The option that

will expand the scope/regulatory attention of the Directive - except what may

be a reduction related to substances in Area A1 and A5.



Figure 5-6 Impact Assessment Option D (IA Option D)

IA Option D

T+ T XnEU

1 2 3 4Oral

mg/kg

1 2 3 4inhal.

vapour

mg/l

inhal.

aerosol

mg/l

1 2 3 4

2 3 4inhal. gas

mg/l

ppm

1 32 4Dermal

mg/kg

0 25 200

0 5 25 50 200 300

0

0,1

0

0

0

0,5

0,5 2 2.5

2

20050 400 1000

0,50,05 0,25 1

500 2000 25001000

10

Boundary

to old

legislation

1

Gyenes

A1 A2

A5

A3

A7A6

A4

A2b

A comparison of the four selected alignment options is shown below.


IA Option A to D

T+ T XnEU

1 2 3 4Oral

mg/kg

1 2 3 4inhal.

vapour

mg/l

inhal.

aerosol

mg/l

1 2 3 4

2 3 4inhal. gas

mg/l

ppm

1 32 4Dermal

mg/kg

0 25 200

0 5 25 50 200 300

0

0,1

0

0

0

0,5

0,5 2 2.5

2

20050 400 1000

0,50,05 0,25 1

500 2000 25001000

10

Boundary

to old

legislation

1

A1 A2

A5a

A3

A7A6

A4

A2b


T+ T

A5b

A8



Option E and E* Instead an alternative option that combines the importance of the uptake routes

and the advantage of a simple alignment could be considered (Option E/E*).

Such an option would be to include:

Inhalation: Acute Toxicity Category 2 and 3;

Dermal:

Acute Toxicity Category 2 and 3; or

Acute Toxicity Category 2 only.

Oral: Acute Toxicity Category 2.

For the dermal exposure route, there is choice as whether to include Acute Tox-

icity Category 3 or not. Including Acute 3 brings in more substances and

thereby increases scope, while leaving out Acute 3 reduces scope.

Figure 5-8 Illustration of Option E and E*

IA Option E and E*

T+ T XnEU

1 2 3 4Oral

mg/kg

1 2 3 4inhal.

vapour

mg/l

inhal.

aerosol

mg/l

1 2 3 4

2 3 4inhal. gas

mg/l

ppm

1 32 4Dermal

mg/kg

0 25 200

0 5 25 50 200 300

0

0,1

0

0

0

0,5

0,5 2 2.5

2

20050 400 1000

0,50,05 0,25 1

500 2000 25001000

10

Boundary

to old

legislation

1

A1 A2

A5

A3

A7A6

A4

A2b

A8

T+ T

Option E, E* Option E E*



5.3 Impact assessment of health hazard options

The impact assessment has covered the following impact:

• Effect of options on scope and regulatory attention. This gives the effect on

the number of establishments in lower and upper tier respectively; and

• Effect on protection level.

The effect on the number of establishments is the main driver for the economic

impacts on industry and CAs, while the impact on the protection level ad-

dresses the health effects (social impacts according to EU IA categorisation)

and environmental effects.

5.3.1 Impact on scope and regulatory attention

The impact assessment builds on the following:

• A questionnaire based survey to all MSs on identification of the most im-

portant substances with the areas A1 to A7 (see Appendix B);

• An industry survey providing quantities of the substances in the areas A2

to A5 in one Member State (France); and

• SPIN database with substance use in the Nordic countries.

There are few data on the use of substances in establishments and therefore, the

impact assessment is based on the above sources which provide indications on

the likely impacts of the options.

Questionnaire The lists of substances indentified for each area are included in Appendix C.

The lists have been drawn up based on the harmonised classifications. The lists

where submitted to Member States and industry representatives to identify the

importance of each substance with respect to industrial use, including high-

volume use and use by many establishments.

MS and industry experts were asked to rank substance according to industrial

importance (see Appendix B for example of questionnaire). The ranking was

from 1 to 3 where 1= important (high volumes and/or many users), 2= maybe

important (medium volumes and some users) and 3= not important (small vol-

umes and few users).

SPIN database The Nordic SPIN database includes substances used in the Nordic countries. It

use to investigate two issues: Firstly, the database was searched for information

on substances registered in total amounts of more than 100,000 tonnes and

1,000,000 tonnes respectively from 2005 to 2007 to see if it included Seveso II-

relevant substances not captured by the lists identified by the TWG. It should

be stressed that the volume levels selected are only an indication of potential

Seveso II sites. However, no additional substances with health hazards relevant

for Seveso II were identified.



Secondly, the database was search to extract quantities for all the substances in

the area A2 to A7. Substances identified under each area were checked against

the SPIN database to test the likely relevance for the Scandinavian countries.

For example 15 of the 22 substances relevant for area 2b were identified in the

database, with potassium hydroxide representing the highest volume. Other

substances were reported in relatively low volumes. Based on the reported data,

the substances were ranked from 1 to 3 similar to the ranking made by MS and

industry experts.

Based on answers from about six Member States and using the Nordic product

database (SPIN) indications of the more relevant substances were compiled; see

Appendix D that includes the complete ranking.

The conclusion in terms of substances identified as most critical is shown in the

tables below. Firstly, the overall results so far is the following regarding the

number of substances.

Table 5-5 Number of critical substance in area43s

Area Number of substances in each area (see

figure below)

Number of critical substances identified

through questionnaire

A1 2 Not included in review

A2 22 9

A2b 48 12

A3 5 1

A4 95 21

A5 26 4

A6 7 6

A7 2 1

Note: Some additional substances were identified by a member state ((A2 plus 7, A2b plus

1, A4 plus 2, A6 plus 6, and a7 plus 1 substance). These are displayed in the table 5.8 be-

low, with the remark 'not initially on list'.

Table 5.7 above for example shows that extending the scope to include A2B

(oral exposure route with 200< LD50 < 250) will increase the number of sub-

stances as will the inclusion of A4 (dermal exposure with 400 < LD50).

In addition to identifying the specific, critical substances in each area, Member

States have provided rough estimates of the potential number of establishments

that could be affected.

Table 5.8 below shows the typical uses and the importance as indicated by

Member States. This list is the best estimate for named substances under the

relevant areas, A1, A2, A3, A5 and A6. The investigation has shown that it is

43 The areas A5b and A8 were only identifying late in the process and therefore not in-

cluded in the survey.

Results of question-

naire



generally not the same substances that are important across on the Member

States that have reviewed the list. It there uncertain to what extent this short list

will mitigate possible reduction in scope. The alternative is to expand the list

and include all the substances that were identified in the relevant areas.

Table 5-6 Important substances (candidates for named substances)

Area Substance Uses Importance

A1 Ergocalciferol (vitamin D2)

(50-14-6)

Not included in the survey Not included in the survey

A2 Epichlorohydrin (106-89-8)

Oxide resins, others; paper industry; a

chemical intermediate used primarily in the

manufacturing of epoxy resins and syn-

thetic glycerol

Rated 1 by three respondents -

one indicates two establish-

ments (plus industry and SPIN

data)

Cadmium oxide (1306-19-0) Electroplating, painting, glass, battery, vit-

reous enamel, making all kinds of alloy and

the raw materials for making cadmium salt

Rated 1 by one (not initially on

the list)

Dimethyl sulphate (77-78-1) Intermediate. Chemical synthesis Rated 1 by one (not initially on

the list)

Acrylamide (79-06-1) Water-soluble polymers used as additives

for water treatment, enhanced oil recovery,

flocculants, papermaking aids, thickeners,

soil conditioning agents, sewage and waste

treatment, ore processing, and permanent

press fabrics.


the list)

Methyl chloroacetate (96-34-

4)

Used in the manufacture of medicines and

pesticides


the list)

Methyl iodide (74-88-4)

Methyl iodide is used as an intermediate in

the manufacture of some pharmaceuticals

and pesticides


the list)

Sodium nitrite (7632-00-0) Colour fixative and preservative in meats

and fish; manufacturing diazo dyes, nitroso

compounds, and other organic compounds;

in dyeing and printing textile fabrics and

bleaching fibres; in photography; as a labo-

ratory reagent and a corrosion inhibitor; in

metal coatings for phosphatising and det-

inning; and in the manufacture of rubber

chemicals.


the list)

Ammonium Dichromate (as

Cr VI) (7789-09-05)

Used as a strong oxidiser Rated 1 by one (not initially on

the list)

A2B Nickel sulphate hexahydrate

(10101-97-0)

Mineral manufacturing; manufacturing of

fabricated metal products, except machin-

ery and equipment

Rated 1 by one (plus SPIN)

Potassium hydroxide (1310-

58-3)

Fertilizer production, household chemical

products; fine chemicals; glue production,

chemical synthesis, maintenance (mineral

industry); used in paint and varnish remov-

Rated 1 by four (plus SPIN data)

Some/many establishments




ers, drain cleaners, degreasing agents and

dairy pipeline cleaners.

Sodium sulphide (1313-82-2) Leather manufacturing; fine chemicals;

water treatment (mineral industry)

Rated 1 by two (plus SPIN)

One respondent indicated few

establishments

1,3-Propanediol, 2-bromo-2-

nitro- (52-51-7)

Preservatives; Adhesive, Paint Rated 1 by one (many estab-

lishments, small volumes, high

importance)

Sodium thiocyanate (Com-

ponent) (540-72-7)

Solvent for acrylic fibre manufacture. Pho-

tochemical bleach. Used in pesticides

Rated 1 by one

Aniline (62-53-3) Pigments and dyes; rubber manufacturing,

industrial solvent, varnishes; others

Rated 1 by two (plus industry) -

many establishments

didecyldimethylammonium

chloride (7173-51-5)

Biocide Rated 1 by one

Methyl acrylate (96-33-3) Plastics, paints, solvents, others; Used as

a monomer or co-monomer in making

acrylic and modacrylic fibres

Rated 1 by two - many estab-

lishments

m-cresol (108-39-4) Many industries; used in disinfectants, in

resins, as a raw material for photographic

developers, in ore flotation, in fumigation

compounds, in explosives, in phenol, as an

insecticide, as a wood preservative, in de-

greasing compounds, in paintbrush clean-

ers and as an additive to lubricating oils. It

is also used as an intermediate in the

manufacture of chemicals, dyes, plastics

and antioxidants. It is used in the manufac-

ture of antiseptics, phosphate esters, her-

bicides and perfumes, as a solvent, as an

engine and metal cleaner and in the textile

industry

Rated 1 by two (plus industry) -

many establishments

Hexylamine (111-26-2) intermediate for pesticides, surfactants,

corrosion inhibitors, dyes, rubber chemi-

cals, pharmaceuticals

Rated 1 by one

Ethylacrylate (140-88-5) Plastics, paints, solvents, others; Interme-

diate for polymers and other chemicals.

Rated 1 by two - many estab-

lishments (plus comment)

Dimethyl disulphate (624-92-

0)

Organosulphur compounds are widely

used in refineries, steam crackers, aro-

matic extraction and petrochemical manu-

facturing


the list)




A3 Formaldehyde (50-00-0) No information Indicated through French survey

Rated one by one in the survey

(by the UK, additional sub-

stance)

2-methylpyridine; 2-picoline

109-06-8

Intermediate used in agrochemicals, indus-

trial chemicals; pharmaceuticals; organic

synthesis,

Indicated through French survey

Rated 2 by one

A4 1-chloro-2,3-epoxypropane

(106-89-8)

Chemical intermediate used primarily in the

manufacture of epoxy resins and synthetic

glycerol. It is also used in the production of

elastomers, polyamines, water treatment

chemicals flame retardants and a variety of

glycidyl derivatives.


2,3-epoxypropyl methacry-

late; glycidyl methacrylate

(106-91-2)

Basic plastic (also used in maintenance

product (mineral industry))

Rated 1 by one

Cyclohexanone (108-94-1) Organic dyes, resins, caprolactam; Produc-

tion of organic peroxides for reinforced

plastics (also used in maintenance product

(mineral industry)); an industrial solvent

and as activator in oxidation reactions

Rated 1 by three (one respon-

dent indicate two establish-

ments)

Phenol; carbolic acid; mono-

hydroxybenzene; phenyl

alcohol (108-95-2)

Plastics, organic synthesis, others; adhe-

sive (also used in maintenance product

(mineral industry))

Rated 1 by three (plus SPIN) -

many establishments

Diethylamine (109-89-7) Corrosion inhibitor and intermediate in the

production of rubber, resins, dyes and

pharmaceuticals.

Rated 1 by one

Morpholine (110-91-8) Manufacturing of ethanol based fuels Rated 1 by one

2-butoxyethanol; ethylene

glycol monobutyl ether butyl

cellosolve (111-76-2)

Paints, others; Glue and paint production

(also used in maintenance product (mineral

industry)); a solvent in paints and surface

coatings


many establishments

Triethylamine 121-44-8) Catalytic solvent in chemical synthesis,

polyurethane foams, rubber, dyes, pesti-

cides, herbicides

Rated 1 by one

Cresol (1319-77-3) Used to dissolve other chemicals, such as

disinfectants and deodorizers, and to make

specific chemicals that kill insect pests.

Rated 1 by one (plus industry)

Sodium dodecyl sulphate

(151-21-3)

Basic plastic; Anionic surfactant for house-

hold products and in gas hydrate or meth-

ane hydrate formation reactions.

Rated 1 by two

Isododecane (31807-55-3 ) Solvent used in chemical synthesis, paints

etc

Rated1 by one

2-aminopropane; isopro-

pylamine (75-31-0)

Solvent, synthetic agent Rated 1 by one (plus SPIN)

Tert-Butyl hydroperoxide

(75-91-2)

Basic plastic and reinforced plastics indus-

try

Rated by one

Isoprene (stabilized); 2- Isoprene is used as a chemical intermedi- Rated 1 by one




methyl-1,3-butadiene (78-79-

5)

ate to manufacture primarily polymers

Acrylic acid (79-10-7)

Production of acrylates; basic plastic (also

used in maintenance product (mineral in-

dustry))

Rated 1 by three

.alpha.,.alpha.-

dimethylbenzyl hydroperox-

ide; cumene hydroperoxide

(80-15-9)

Reinforced plastics industry - many estab-

lishments (also used in maintenance prod-

uct (mineral industry))

Rated 1 by one

hexamethylene diisocyanate

(822-06-0)

Plastics, others Rated 1 by one - many estab-

lishments

o-cresol (95-48-7) PU foams, others - many establishments Rated 1 by one - many estab-

lishments

Maleic anhydride (108-31-6) A highly versatile chemical intermediate

essential to the production of a multitude of

products


the list)

1, 3 - dichloropropene (542-

75-6)

Used as a solvent in polystyrene manufac-

ture as well as SBR Latex Production.

Used in fungicides for agriculture, garden

and health service use. Used in pesticide

products and as a soil fumigant/ nemati-

cide.


the list)

A5

1,4-dichlorobut-2-ene (764-

41-0)

Intermediate in preparation of nylon Rated 1 by one

Phosphorus trichloride

(7719-12-2)

PCl3 is important indirectly as a precursor

to PCl5, POCl3 and PSCl3


Iodine (7553-56-2) Chemical synthesis, pharmaceutical indus-

try (also used as laboratory chemical (min-

eral industry))

Rated 1 by one

Sulphuric acid mist (7664-

93-9)

Fertilizer production, for leather manufac-

turing, water treatment; chemical synthesis,

glass polishing, manufacturing, paint pro-

duction


many establishments

Methanesulphonyl chloride

(124-63-0) No information


2-(Dimethylamino)ethyl acry-

late (2439-35-2)

Bis(2-chloroethoxy)methane is a syn-

thetic organic compound, chiefly used

on site in the production of polysulfide

polymers.(Solvent; intermediate for

polysulfide rubber)


Rated 2 by one

Ethyl chloroformate (541-41-

3)

Pharmaceuticals industry, and also

used as an intermediate for the pro-

duction of peroxide chemicals, dyes,

crop protection chemicals and plastics.


(Rated 2 by one)

Chlorothalonil (1897-45-6)

Used in consumer products, building

materials or furnishings that contribute

to indoor air pollution. Used in pesti-

cide products. Chlorothalonil is used to


Rated 2 by two.




kill fungal diseases in crops (fungi-

cide).

Vitamin D3 (67-97-0) Nutritional supplement Indicated through French survey

Phosphorus oxychloride

(10025-87-3)

The most important use for phosphoryl

chloride is in the manufacture of tri-

arylphosphate esters such as triphenyl

phosphate and tricresyl phosphate.

These esters have been used for many

years as flame retardants and plasti-

cisers for PVC. Many other uses.


Rated 2 by two

Hydrogen fluoride (7664-39-

3)

No information Indicated through French survey

A6 Sulphur dioxide (7446-09-5) Sulphur dioxide is sometimes used as a

preservative in alcoholic drinks, or dried

fruit such as apricots and raisins, due to its

antimicrobial properties. The preservative

is used to maintain the appearance of the

fruit rather than prevent rotting.


the list)

Ethylene oxide (75-21-8) Used as an intermediate in the production

of ethylene glycol and other chemicals, and

as a sterilant for foodstuffs and medical

supplies.


the list)

Acetic anhydride (108-24-7) Used for acetylation of alcohols and

amines.


the list)

Cyclohexanone (108-94-1) Industrial solvent and as activator in oxida-

tion reactions


the list)

Tert-butyl acrylate (1663-39-

4)

Used in rigid and semi-rigid acrylic plastics. Rated 1 by one (not initially on

the list)

Pentane - 2, 4, dione (123-

54-6)

A colourless to slightly yellow liquid with a

pleasant odour. It is used in the manufac-

turing of colours, paints, varnishes, resins,

inks, dyes, pharmaceuticals, and other

chemicals, as a pesticide, and as an addi-

tive to gasoline


the list)

A7 Ammonia (7664-41-7) Most important use is in the production of

nitric acid.


the list)

Assessment of impacts of each area

This section includes an assessment of the implication of alternative options for

each of areas A1 to A7.

Indicator approach The assessment is based on a developed indictor of the effect of including or

excluding each of the "boundary" areas. In order derive a quantitative estimate

of the impacts of the options, the ratios between the number of industry-



relevant substances in each area and total T+ or T industry relevant substances

are calculated.

This indicator is then used as input to estimate the effect on the number of es-

tablishments. This requires some further assumptions. If one option will in-

crease the number of substance by 10% it can not be assumed that the number

of establishments will increase by 10%. The following factors should be con-

sidered:

• What is the share of companies that are covered by Seveso due to the

health hazard categories?

• What is the share of establishments that can avoid coming into scope for

example through supply chain modification?

• For substances moving from T+ to T, those establishments that use the

substances in more than 50 tons will still be within scope, so what is that

share?

• Some options could include named substance as a compensation so what is

the effect of named substances?

Critical assumptions These factors should be considered to allow the estimate of how changes in the

number of substances within the toxic category can be transformed to an esti-

mate of the change in the number of establishments that are within scope.

The share of establishments that fall within the scope of Seveso II due to usage

of substances in toxic and very toxic categories is not known. It is important for

the estimation of the impact of the health hazard options, the more establish-

ments that coming into the scope of Seveso II due to these categories, the more

effect will the choice of option have and vice versa if the share is low. A rough

estimate is that the share of establishments falling within the scope due to

health hazards is about 30 per cent.

The lower thresholds for substances classified as very toxic makes it plausible

to assume that T+ category accounts for more than the T category. It is assumed

that T+ accounts for 70 per cent of the establishments coming into scope of

Seveso due to toxicity categories and toxic category T accounts for the residual

30 per cent.

It is recognised that companies often are able to modify their behaviour and

thereby avoid coming within scope of the Seveso II. This could reduce the im-

pact of any change to the classifications. In this indicator approach we will not

make a correction for this factor. The estimation will be done as percentage

change compared to the existing number of establishments. It must be assumed

that the current number already incorporates such behaviour and therefore mak-

ing a further correction would be to double-count this element.

T+ to T thresholds The last factor to consider regards establishments that are in due to the T+

category and the 5/20 tonnes thresholds. It is assumed that 50 per cent of the

Importance of health

hazards

Avoidance of Seveso

II



establishments falling within the scope due to the T+ category store less than 50

tonnes. These establishments will fall outside the scope if substances in A1 and

A5 would go from the T+ thresholds of 5/20 to the T thresholds of 50/200.

Results By applying these assumptions, the resulting impact on the number of

establishments can be estimated. It cannot be sufficiently stressed that this is

just an estimate. However, sensitivity analyses show that the assumptions have

to be radically changed to make a significant impact on the number of estab-

lishments.

The first step in the indicator approach is to estimate the impact of each area.

Number of substance in each area compared to total number of substances

within T+ and T which are estimated to about 21 and 87 substances respec-

tively.

Table 5-7 Impact of substances in areas A1 to A7

Area Number of substances Net effect

T+ T T+ T

A1 2 -10%

A2 9 -10%

A2b 12 14%

A3 1 -1%

A4 21 24%

A5 4 -19%

A6 6 -7%

A7 1 1%

Total number of substances 21 87

Source: Consultant's estimate

The net effect indicated in the table is the measured as increased or decreased

number of T+ or T substances. For example, the 14 per cent for A2b indicates

that if A2b is included then the number of T substances will increase by 14 per

cent.

To derive at the estimate for number of additional establishments the

assumptions described above are applying. It is assumed that 30% of estab-

lishments are in scope due to the heath hazards and that 30% of that is for the

T, the toxic category. This then reduces the 14% to 1. 2%. The impact on the

number of establishments of application of the above is shown in Table 5-15

below.



Table 5-8 Estimated impact on number of establishments

Absolute effect on no of establishments Relative effect in %

Lower tier Upper tier Total Lower tier Upper tier

A1 -60 -45 -105 -1.1% -1.0%

A2 -49 -42 -91 -0.9% -0.9%

A2b 65 56 121 1.2% 1.2%

A3 -5 -5 -10 -0.1% -0.1%

A4 114 98 211 2.2% 2.2%

A5 -119 -90 -209 -2.3% -2.0%

A6 -32 -28 -60 -0.6% -0.6%

A7 5 5 10 0.1% 0.1%


The analysis shows that impacts are relatively moderate. Inclusion of area A2b

which is to include Acute 3 for the oral exposure route will increase the number

of establishments with about 1%. The reduction of number of establishments

resulting from the change in thresholds for area A5 (where substances are going

from T+ to T for the inhalation aerosol exposure route could be somewhat

higher - up to two percentage or more.

The effect of named substances is difficult to assess. It is only possible to in-

clude all identified substances in the areas but not those that are self classified.

The lists based on the harmonised classification are only used as indicators for

the importance of each area. There is no information about how many estab-

lishments are within scope due to self classified substances.

In order to understand what could be the effect of using named substances to

compensate for any reduction in scope, a scenario has been defined where it is

assumed that naming substances would remove 50 per cent of the decrease in

scope for the relevant areas. The effects are shown in Table 5-9 and Table 5-10.

Table 5-9 Impact of substances in areas A1 to A7

Area Number of sub-

stances

Effect of named

substances

Net effect

T+ T T+ T

A1 2 100% 0%

A2 9 50% -5%

A2b 12 14%

A3 1 50% -1%

A4 21 24%

A5 4 50% -10%

A6 6 50% -3%

Named substances

scenario



Area Number of sub-

stances

Effect of named

substances

Net effect

A7 1 1%

Total number of

substances 21 87


Table 5-10 Estimated impact on number of establishments from named substance

scenario with 50% effect on scope reductions



A1 0 0 0 0.0% 0.0%

A2 -24 -21 -45 -0.5% -0.5%

A2b 65 56 121 1.2% 1.2%

A3 -3 -2 -5 -0.1% -0.1%

A4 114 98 211 2.2% 2.2%

A5 -60 -45 -105 -1.1% -1.0%

A6 -16 -14 -30 -0.3% -0.3%

A7 5 5 10 0.1% 0.1%


Sensitivity analysis The following sensitivity analysis has been made:

• The share of establishments falling within the scope of Seveso II due to the

health categories up from 30 per cent to 50 per cent

• The impact on number of substances increases by a factor of 2

• The share of T+ establishments with less than 50 tonnes up to 80 per cent

• All three alternative assumptions combined.

The results are shown in the below tables.

Table 5-11 Estimated impact on number of establishments using 50 per cent in

scope due to health categories



A1 -99 -75 -174 -1.9% -1.7%

A2 -81 -70 -151 -1.6% -1.6%

A2b 108 93 201 2.1% 2.1%

A3 -9 -8 -17 -0.2% -0.2%





A4 189 163 352 3.6% 3.6%

A5 -199 -150 -348 -3.8% -3.3%

A6 -54 -47 -101 -1.0% -1.0%

A7 9 8 17 0.2% 0.2%

Table 5-12 Estimated impact on number of establishments due to increased effect

on number of substances by a factor of 2



A1 -119 -90 -209 -2.3% -2.0%

A2 -97 -84 -181 -1.9% -1.9%

A2b 130 112 241 2.5% 2.5%

A3 -11 -9 -20 -0.2% -0.2%

A4 227 195 422 4.3% 4.3%

A5 -238 -180 -418 -4.6% -4.0%

A6 -65 -56 -121 -1.2% -1.2%

A7 11 9 20 0.2% 0.2%

Table 5-13 Estimated impact on number of establishments of the share of T+ estab-

lishments with less than 50 tonnes up to 80 per cent



A1 -87 -72 -158 -1.7% -1.6%

A2 -49 -42 -91 -0.9% -0.9%

A2b 65 56 121 1.2% 1.2%

A3 -5 -5 -10 -0.1% -0.1%

A4 114 98 211 2.2% 2.2%

A5 -173 -144 -317 -3.3% -3.2%

A6 -32 -28 -60 -0.6% -0.6%

A7 5 5 10 0.1% 0.1%



Table 5-14 Estimated impact on number of establishments from all three alterna-

tive assumptions combined



A1 -289 -240 -528 -5.5% -5.3%

A2 -162 -140 -302 -3.1% -3.1%

A2b 216 186 402 4.1% 4.1%

A3 -18 -16 -34 -0.3% -0.3%

A4 379 326 704 7.2% 7.2%

A5 -577 -480 -1057 -11.0% -10.7%

A6 -108 -93 -201 -2.1% -2.1%

A7 18 16 34 0.3% 0.3%

The sensitivity analysis has shown that unless the assumptions are all changed

in the same direction, the overall impacts on the number of establishments are

moderate.

5.3.2 Impacts on options

The impact of the options area estimated as the sum of the results of each of the

areas. The resulting impacts measured as changes to the net number of estab-

lishments could therefore include the fact that some establishments are left out

of scope while other are included giving a limited net effect.

Table 5-15 Impact of options on number of establishments

Option Number of establishments % change in no of establishments

Lower tier Upper tier Lower tier Upper tier

Option A 0 0 0.0% 0.0%

Option B -206 -136 -3.3% -3.0%

Option C -54 -34 -1.1% -0.9%

Option D 65 68 1.1% 1.4%

Based on the approach chosen, Option A which applies a screening tool to en-

sure that the current scope is maintained will therefore have no impact. Option

B which is a simple alignment using Acute 1 for T+ and Acute 2 for T (for

relevant exposure routes, see Section 5.1 for details) will imply some reduction

in scope.

Option C that uses Acute 2 and 3 for T will only entail a minor net reduction in

the scope. Behind that result is the combination of an increase from the inclu-

sion of area A2b and a decrease from the use of only Acute 1 for T+ - area A5.



The variation of C, Option C* which includes Acute 2 inhalation aerosol as T+

implies a slight increase in scope from Area A2b. The effect on this is similar

to assume that named substances mitigate 100% of the possible reduction in

scope, see Table 5.11.

Option D will lead to an increase in scope and as the area A8 has not been as-

sess the results shown here is an underestimation of the possible increased

scope resulting from this option.

The consequences of having an amended derogation rule and safety clause de-

pends on how they will be designed and applied. In principle these provision

could limit the deviations from the current scope. Potentially they could prevent

any change in scope. In such case the there would be no change in the number

of establishments for any of the for options.

Table 5-16 Impact of options on number of establishments assuming that a deroga-

tion rule and a safeguard clause are effective in maintaining scope



Option A 0 0 0,0% 0,0%

Option B 0 0 0,0% 0,0%

Option C 0 0 0,0% 0,0%

Option D 0 0 0,0% 0,0%

The results for four options could be sensitive to some of the key assumptions

that have been applied. The main assumption to test in a sensitivity analysis is

the assumption that named substances compensate for about 50% of the effect

of leaving out one of boundary areas.

Table 5-17 Impact of options on number of establishments assuming that named

substance compensate 50% for a reduced area



Option A 0 0 0.0% 0.0%

Option B -103 -68 -1.7% -1.5%

Option C 8 13 0.0% 0.2%

Option D 124 113 2.3% 2.4%

If it is assumed that all relevant T+ and T substances can be identified and in-

cluded as named substances, then Option B will maintained scope while Option

C will imply a minor increase in scope. The more precautionary alignment in

Option D will lead to a more significant increase in scope.

Derogation rule sce-

nario

Named substance

scenario



Naming of substances is probably going to be more difficult that first envis-

aged.

5.3.3 Scope impact - short and long term

The discussion has so far been addressing the more immediate impact on the

scope compared to the current situation.

In the longer term, the impacts would be different. New substances will be clas-

sified according to the CLP categories and the testing of the substances will be

target to the LD/LC values at the boundaries between the CLP categories and

not those around T+ and T.

For new substances being self classified by industry, there will be limited in-

centive to identify those new substances which has a major hazard accident po-

tential if they are not within scope based on their CLP classification.

This means in relation to the mitigation approaches:

• Named substances: This approach will not take new substances into ac-

count unless there is a new revision process to identify additional sub-

stances to be included as named substances.

• Screening tool: This approach will discriminate between substances where

there are LD/LC values for the boundaries T+ and T and those without. If a

"screening in" approach is applied then future substances are less likely to

be included in scope of the Seveso II.

• Derogation rule/safety clause: The long term effects depend on the align-

ment option. If the alignment option is inclusive as Option D with Acute 3

included, then it will maintain scope also in the long term. Substances are

by default included and the derogation rule will prevent an unnecessary in-

crease in scope. Substances with no major accident hazard potential are

likely to be identified by industry if they would lead to new installations

could come within scope.

The conclusions regarding the four options are:

Table 5-18 Overview of impacts of alternative alignment options - no derogation

rule/safety clause

No derogation rule With derogation rule

Scope (short term) Scope (long term) Scope (short term) Scope (long term)

Option A No change Reduced No change Reduced

Option B Reduced Reduced No change Reduced

Option C Slightly decreased Slightly reduced No change Slightly Reduced

Option D Increased Increased No change No change



Without the amended derogation rule in place Option C results in overall fewer

changes to scope, while with an amended derogation rule it is Option D that

best maintains scope.

5.3.4 Administrative aspects of options

The options that are based on the differentiated exposure routes will require

more effort in collecting data to assess the three inhalation exposure routes.

This information will not be displayed at the typical product label.

Similarly, the screening tool will require an additional effort to investigate the

status of the substances with an Acute 2 or an Acute 3 classification.

The exact resource requirement for these approaches depends on many factors

and as they are not applied current, the resource requirements can only be esti-

mated based on a rough expert judgement.

The resource needs when choosing one of the options with differentiated expo-

sure routes (Option A, B and C) can be estimated based on the following as-

sumptions:

• Each company spend three and half days on reviewing their substances by

exposure routes to determine their Seveso II classifications44;

• The relevant number of Seveso II establishments is assumed to be 30% of

total number of 9725 Seveso II establishments. 30% is that assumption for

the share that is within scope due to health hazards.

• The number of non-Seveso II establishments that need apply the screening

procedure to check whether they might fall within scope is assumed to be

50% of the number of Seveso II establishments;


Based on these assumptions, a rough estimate is the there is one-off costs of

having to collect additional information to determine classification by exposure

routes and thereby determine the Seveso II status of 5.4 million EUR. If this

cost is annualised over 5 years and with 4% discount rate, the annualised costs

are 1.2 million EUR.

44 This is based on an average of 27 substances per establishment and using around one

hour per each substance. The average number of substances is estimated based on the

French industry survey. 45 Average annual gross earning in EU27 was EUR 31300 in 2006 based on Eurostat data.



salaries. This is assumed to be at least twice and rounding the number, 350 per day is used.

Administrative costs

for differentiated

exposure routes



This is an order of magnitude estimate. First of all the average number of sub-

stances that each establishment need to review is not known and also the num-

ber of establishments both currently Seveso II sites and non-Seveso sites that

need to review the substances could vary from the above assumptions.

The screening tool option requires a process to determining whether a certain

substance belongs to either of the toxicity categories. Option A Screening tool -

see Section 4.2.1 for detailed description - will require either of the following

procedures:

• A committee dealing with substances and producing lists of substances that

have been analysed using the screening tool

• Applied by industry as part of their self classification.

A committee would require that Member States can agree on such a set-up and

that resources can be allocated. It would only be possible to review the sub-

stances that have been identified and/or classified. All self-classified substances

as well as new future substances would not be covered by this procedure.

The most practical way to implement the option would be to incorporate the

screening process in the Annex 1 and make it a requirement that companies use

it for self classification.

In case a screening or decision tool approach should be chosen, it should be

part of the Annex 1, as a procedure to apply by industry.

To roughly assess the possible resource requirement for the screening tool, the

following assumptions can be applied:

• Each company spend three and half days on applying the screening tool

procedure46;

• The relevant number of Seveso II establishments is assumed to be 30% of

total number of 9725 Seveso II establishments. 30% is that assumption for

the share that is within scope due to health hazards.

• The number of non-Seveso II establishments that need apply the screening

procedure to check whether they might fall within scope is assumed to be

50% of the number of Seveso II establishments;


46This is based on an average of 27 substances per establishment and using around one hour

per each substance. The average number of substances is estimated based on the French

industry survey. 47 Average annual gross earning in EU27 was EUR 31300 in 2006 based on Eurostat data.



Administrative pro-

cedures and costs for

the screening tool



Based on these assumptions, a rough estimate is the there is one-off costs of

applying the screening tool of 5.4 million EUR. If this cost is annualised over 5

years and with 4% discount rate, the annualised costs are 1.2 million EUR.

This is an order of magnitude estimate. First of all the average number of sub-

stances that each establishment need to review is not known and also the num-

ber of establishments both currently Seveso II sites and non-Seveso sites that

need to review the substances could vary from the above assumptions.

5.3.5 Cost impact of options

The estimation of the individual costs elements provides only order of magni-

tude values. There are many factors that can influence the costs and the avail-

able information does not allow for a more accurate assessment.

The costs impacts are summarised in the Table 5-19. The displayed costs in-

clude under the heading General adaption:

• A one-off adaption to the CLP that is common for all alignment options

(see Section 3.4.1);

• The above described costs for differentiated exposure routes (Option A to

C) and the screening tool (Option A only).

Under the heading Change in scope, the costs for either reduced or increased

number of establishments are included, see Section 3.4.1 for the unit costs and

Table 5-15 for the assumption about the number of establishments.

Table 5-19 Costs impacts of alternative alignment options

Annual costs

General adaption Change in scope Total

Option A 4,100,000 - 4,100,000

Option B 2,900,000 -5,100,000 -2,200,000

Option C 2,900,000 -1,300,000 1,600,000

Option D 1,700,000 2,400,000 4,100,000

Without introduction of named substances or derogation rule/safety clause, Op-

tion B and C result in a reduced scope and therefore costs savings are dis-

played. If the reduction in scope is mitigated for example by introduction of an

amended derogation rule and a safety clause, the change in scope could be

minimised the general administrative adaption costs will be the main cost ele-

ments.

salaries. This is assumed to be at least twice and rounding the number, a day rate of 350

EUR is used.

Comparison of

options



Which of the alignment option that comes out as the most preferred will thus

depend on whether the derogation rule will be amended or not.

• With no derogation rule/safety clause:

- In this scenario, Option C seems most favourable. It is closest to main-

tain scope and less administrative costs than the screening tool option

A.

• With a derogation rule/safety clause:

- In this scenario Option D comes out most favourable. It is a simple

alignment that requires the least administrative effort and with the

derogation rule the increase in scope can be avoided.

The cost assessment provides an order of magnitude estimate. With regard to

the effort of understanding the new classification and their specific Seveso II

impacts, they main uncertainty is how long time each establishment need to

spend on reviewing the substance inventories with respect to the new CLP clas-

sifications and the revised Annex I definitions.

Administrative costs In relation to the differentiated exposure routes and the screening tool, the

assumption is the average time per establishment is about 3.5 days based on

estimate of around 25 substances and 1 hour per substance. This is very much a

guesstimate; the time need could probably vary between 1 day and a week.

Table 5-20 Sensitivity of the estimate of the costs of administrative adaption - time

requirement for applying differentiated exposure routes and screening

tool - € per year

1 day 3.5 days 5 days

Option A 2,400,000 4,100,000 5,200,000

Option B 2,100,000 2,900,000 3,400,000

Option C 2,100,000 2,900,000 3,400,000

Option D 1,700,000 1,700,000 1,700,000

With regard to the impacts on scope, the sensitivity in terms of number of es-

tablishments was described in Section 5.3.2 above. The unit cost could also

vary and there could be an asymmetry between decreases and increases in

scope.

Sensitivity on cost

assessment

Unit costs for scope

change



The sensitivity of the unit costs is shown in Table 5-21.

Table 5-21 Sensitivity of the estimate of the costs of scope change in € per year

Low Medium High

Option A - - -

Option B -1,200,000 -5,100,000 -15,400,000

Option C -300,000 -1,300,000 -3,900,000

Option D 500,000 2,400,000 7,100,000

Named substances If it is assumed that named substances can partly mitigate the reduction in

scope that follows from all but Option D, the cost impacts will be as displayed

below.

Table 5-22 Sensitivity of the estimate of the costs of scope change assuming the

named substances can mitigate 50% of reduction in scope - in € per

year

Low Medium High

Option A - - -

Option B -600,000 -2,600,000 -7,700,000

Option C 100,000 400,000 1,300,000

Option D 900,000 4,000,000 12,000,000

Net and gross impacts Establishments already Seveso II sites might not experience much cost savings

as a result of the changed status. They have already invested in safety reports,

safety systems and emergency plans and in physical modifications if that were

necessary. They will only save future updates of the plans. In terms of financial

impacts on industry, there is likely to be asymmetric effects so the cost savings

for one establishment falling out of scope will not offset the additional costs for

a new establishment coming into scope. The total aggregated costs could there-

fore increase even if there is no net increase in the number of establishments

falling within scope.

A sensitivity analysis is presented in below table where the costs are estimated

using the assumption that the annual saving is only about 20% of the costs.

In this case the annual costs of all options except Option A will increase.



Table 5-23 Sensitivity analysis: Estimate of cost impact assuming that unit savings

from reduced scope are only 20% of the unit costs from increased scope

- in € per year

EUR per year Low Medium High

Option A - - -

Option B -200,000 -1,000,000 -3,000,000

Option C 300,000 1,300,000 3,900,000

Option D 1,100,000 4,800,000 14,500,000

5.3.6 Changes in level of protection

The questionnaire survey identified a gross list of substances for which the

status under the Seveso II Directive may change. The survey also identified a

subset of this gross list for which the industrial importance is judged to be "par-

ticularly important". It is relevant to attempt to assess the actual major-accident

significance of the substances in this subset, i.e. their relative contribution to

the level of protection offered to the general public by the Seveso II Directive.

This information is important in the evaluation of the potential impact of any

decision to include or exclude the substances from the scope of Seveso II.

The Seveso II Directive is a regulatory regime aimed at a limited number of

industrial sites that "in true process safety terms" represent high priority haz-

ards. The purpose is to concentrate regulatory attention on sites that pose the

highest risk. Sites not covered by Seveso II are meant to be proportionately

controlled by general provisions on health, safety and the environment, which

are not specific to "major-accident hazards". The definition of a "major acci-

dent" in the original Seveso Directive (82/501/EEC) was an accidental event

that could cause harm to the general public outside the industrial premises. This

definition has been modified in the Seveso II Directive also to include harm to

employees. However, the review and qualified discussion in this section of the

extent to which a substance may cause a "major accident" will lean on the

original meaning of this concept.

There is no generally accepted methodology to assess the major-accident poten-

tial of a dangerous substance. As earlier work [Wood 2009] has noted, the haz-

ard potential of substances with toxic properties is very difficult to capture in a

generic way. The major-accident potential is not only "substance-dependent",

i.e. dependent on toxicity (exposure route, persistence and type of effect) and

physical-chemical properties that determine emission potential (with volatility

as the most important parameter). The major-accident potential is also "sce-

nario-dependent", i.e. dependent on the specific and often unique conditions at

the local site that determine the potential for an accidental release of a danger-

ous substance, which may affect the surroundings of the site. An example is a

toxic substance that is not volatile at normal temperatures, but may be subjected

to elevated temperatures, perhaps accidentally, at which it may become volatile.

Non-volatile substances may also be pressurized, or mixed with non-toxic sub-

stances that may cause it to be pressurized, for instance during an accidental



mixing scenario, after which it may be released as a spray/mist/aerosol through

overpressure venting devices, enabling it to reach the surroundings. The idea

that major-accident potential cannot be captured by substance-properties alone

is also evident in Article 1 of the first Seveso Directive (82/501/EEC), which

included a combination of specific types of "industrial installations" and spe-

cific substances in its scope.

A relatively simple and traditional approach is to use past experience as guid-

ance, i.e. simply to assess the major-accident potential of a substance from its

accident history. The availability of a large number of reported accidents in-

volving a particular substance is considered a strong and reliable indicator for a

high major-accident potential. It is more difficult to assess the significance of

the absence of a clear accident history. However, if a substance has been used

in considerable quantities over a prolonged period of time, an absence of an

accident history may reasonably be interpreted as strongly indicative of a low

major-accident potential.

A second parameter in the assessment of a substance's major-accident potential

would relate to exposure - the ability to reach the surroundings of an industrial

site. Experience has clearly shown that atmospheric dispersion is the most sig-

nificant mechanism for projecting danger to the surroundings of an industrial

installation. For instance, the twenty most commonly reported chemicals in the

database over US chemical accidental releases comprise 13 gasses and two

highly volatile liquids (Kleindorfer et al. 2000). Volatility is therefore a very

important parameter in an assessment of a substance's major-accident potential.

A third parameter in the assessment if a substance really represents "high prior-

ity hazards" would be the magnitude of the quantities that are present on a site.

This severity parameter is defined in the qualifying quantities for upper or

lower tier coverage in Seveso II and is beyond the scope of the present discus-

sion of major-accident potential.

Using the approach outlined above, the major-accident potential of a substance

could be assessed on two parameters, accident history and volatility, for which

arbitrary scores major-accident potential, could be assigned using a matrix.

Experience parameter (accident history)

Accident reports are notoriously difficult to interpret; at times it is even diffi-

cult to determine the extent to which the substances reported were relevant for

the accident causality. An assessment of the strength of the evidence is there-

fore necessary. The accident history parameter will be assessed using the fol-

lowing scale:

0. No relevant reported accidents identified

1. Unlikely - Some reported accidents, but unclear if substance is involved in

causality or harmful effect - involvement is judged as unlikely



2. Possible - Some reported accidents, but unclear if substance is involved in

causality or harmful effect - involvement is judged as possible

3. Probable

3a - Some reported accidents, but unclear if substance is involved in cau-

sality or harmful effect - involvement is judged as probable

3b - Some reported accidents with off-site impact, but unclear if substance

is involved in causality or harmful effect - involvement is judged as prob-

able

4. 4 - Evident

4a - Some reported accidents, it is evident that substance is involved in

causality or harmful effect

4b - Some reported accidents with off-site impact, it is evident that sub-

stance is involved in causality or harmful effect

5. Obvious - Many reported accidents with off-site impact, obvious high major

accident potential

NA - No reported accidents identified but there are reservations if an absence of

evidence can be taken as evidence of absence of major-accident potential, e.g.

due to lack of information on usage patterns.

Exposure parameter (volatility)

1. Solid phase, e.g. particles, at NTP (normal temperature and pressure). Acci-

dental release scenarios that could cause the substance to affect may affect

the surroundings of the site are considered unlikely or very rare

2. Liquid at NTP - high boiling point (201+). Accidental release scenarios that

could cause the substance to affect may affect the surroundings of the site are

considered unlikely

3. Liquid phase at NTP - medium boiling point range (101-200). Accidental

release scenarios that could cause the substance to affect may affect the sur-

roundings of the site are considered possible but improbable

4. Volatile liquids

4a - Volatile liquid (75-89) at NTP. Accidental release scenarios that could

cause the substance to affect may affect the surroundings of the site are

considered possible but not common

4b - Volatile liquid at (50-74) NTP. Accidental release scenarios that

could cause the substance to affect may affect the surroundings of the site

are considered possible



4c - Volatile liquid at (26-49) NTP. Accidental release scenarios that could

cause the substance to affect may affect the surroundings of the site are

considered probable

5. Gas (-25) at NTP. Accidental release scenarios that could cause the substance

to affect may affect the surroundings of the site are considered likely

NA - not enough information to assess exposure parameter.

Matrix assigning major-accident potential score

Based on expert judgement the following arbitrary major-accident potential

scores have been assigned to each combination of experience parameter and

exposure parameter. The scores reflect that readily available empirical evidence

of an accident history is highly significant for the major-accident potential

score. Such scores can always be debated but they are thought to provide a fair

and somewhat cautious assessment of the major-accident potential.

Major-accident potential matrix and numerical score

Experience parameter (accident history)

Probable Evident Obvious

0 - none 1 - unlikely 2 - possible 3a - on site 3b - off site 4a - on site 4b - off site 5 - off site NA - Lack of info

Exposure

parameter

1 - solid

unlikely 0 1 20 50 90 95 100 100 5

2 - liquid high BP

unlikely 0 5 30 60 95 95 100 100 10

3 - liquid medium BP

possible but improbable 2 5 40 75 95 95 100 100 20

4a - volatile liquid

low probability 5 5 50 80 95 100 100 100 40

4b - volatile liquid

possible 10 20 60 80 95 100 100 100 50

4c - volatile liquid

probable 20 30 75 90 95 100 100 100 80

5 - gas

likely 50 75 90 95 100 100 100 100 90

NA -

Lack of info 25 40 75 90 100 100 100 100 75

Methodology

The accident history parameter will be scored based on

• A free-text search in EU's Major Accident Reporting System (MARS)

based on the CAS number of the substance. Because public access to the

MARS data has recently been restricted, it was necessary to carry out the

search on an in-house copy of the MARS registrations from 2006.

• A free-text search in the Accident Database that is provided commercially

by the UK Institution of Chemical Engineers (IChemE). The search is

based on its common substance name, or in case of name ambiguities, al-

ternative common names.

• A Google search of the Internet for "X accident" where x is the common

substance name. Typically, the first fifty search results have been re-

viewed.



The sequence of this search procedure has not been strictly maintained, and the

search has been terminated when sufficient information was available to assign

a high accident-history score.

The exposure parameter has been scored based on readily available information

on phase and volatility primarily obtained from searching the Internet.

Interpretation ambiguities arising over the course of the work

Several interpretation ambiguities have arisen during the data collection phase.

All the substances identified in the questionnaire survey have been included

due to different aligning criteria for toxicity. A complication may arise if a sub-

stance presents a positive accident history but when the observed dangers are

not associated with the toxic properties of the substance.

The formaldehyde case is instructive here. Formaldehyde is included in the

survey due to it being an A3 substance [and phenol an A4 substance], both

based on dermal toxicity. However, formaldehyde is used in large quantities in

the phenol-formaldehyde process that produces a common industrial binder

(resin). The phenol-formaldehyde process has a long track record of so-called

run-away incidents, in which an extremely rapid temperature and pressure ex-

cursion leads to a violent explosion of the reaction vessel. The accidents are

reported to have had consequences for the general public. The substance clearly

has a major -accident potential, the concern being reactivity, not necessarily

toxicity. Yet, there is no generic Seveso II category for "reactivity hazards" and

formaldehyde is thus included in Seveso II for its toxic (dermal) properties.

Because inclusion in the Seveso II regulatory regime triggers a requirement to

carry out a formal risk identification (and risk assessment) involving all dan-

gerous substances on the site, irrespective of their quantity, a diligently carried

out analysis will also identify the reactivity issue. This is an unintended effect

of the Seveso II requirements, but it nevertheless is important for the level of

protection the current Directive offers the general population.

Similar arguments can be pursued for other substances, e.g. maleic anhydride

(accident history points to hazards to due to chemical incompatibilities), cyclo-

hexanone (accident history points to hazards to due to flammable properties),

nitrite and sulphide salts (accident history points to hazards to due to evolution

of toxic gas when accidental mixing with incompatible chemicals).

Following this level of reasoning, there has been no attempt to reduce or other-

wise modify the experience score, even if concerns other than toxicity effects

are dominant in the accident history of a substance that is included solely for

toxic properties. The reasoning is in line the with the basic approach in the

scores of the major-accident potential matrix - that readily available empirical

evidence of an accident history is highly significant for the major-accident po-

tential score



Results

The scores fall in two major and somewhat extreme categories, those which are

hardly any concern (48 per cent), and those which definitely are a concern (38

per cent), and a small group (13 per cent) in between.

The below table relates the scoring to the areas A2 to A7. The categorisation

has been done by grouping the scores into high (above 70), medium (between

30 and 70) and low (less than 30). For the areas of substances indentified as

most relevant (see Section 5.3.1) the number within each of the three categories

of major accident potential scores has been calculated.

Table 5-24 Major accident potential scoring of important substances by area

High Medium Low Total

A2 4 0 7 11

A2b 1 1 18 20

A3 1 0 0 1

A4 7 1 13 21

A5 2 0 2 4

A6 4 0 2 6

A7 1 0 0 1

The scoring of the manor accident potential provides a rough assessment pro-

tection level. The substances that have been identified in the questionnaire

could for example be included through other classification categories or there

could be other considerations relevant for specific substances.

Given the assumption and approach used for this assessment, the results of the

scoring can be summarised for the four options.

Table 5-25 Impact of options measured as number of substances in on major

accident potential categories

Option High Medium Low

Baseline 11 0 11

Option A 11 0 11

Option B 5 0 2

Option C 12 1 29

Option D 20 2 42

An option that includes more of high-scored substances should have a higher

protection level. On the other hand, including many substances with a low



score means higher costs of compliance with no associated benefit. It should be

stressed that this is just a rough indicator of the protection level.

5.3.7 Impacts of option E and E*

The impacts on scope of an option which differentiate between the main uptake

routes and include Acute Tox 3 for inhalation (and dermal) is different from

Option B to D as analysed above as it will mean a combination of increased and

decreased scope. There will be more substances included from inhalation

through the sub-exposure routes vapour and gas, while there will be a reduction

for the oral exposure route.















5.4 Industry survey of relevant industries in France

This section includes a description of a industry survey undertaken in France. It

provides quantitative results regarding the use of the substances in boundary

areas and it also allows using to aggregation rule to the overall effects.

The results are compared to the broader more qualitative Member State survey

which is the foundation for the indicator analysis presented above.

Based on the high level of information held by the French central authority and

the French tradition for industry consultation and high response rates to indus-

try surveys, the Ministère de l'Ecologie, de l'Energie, du Développement dura-

ble et de la Mer made a quantitative assessment of the use of the substance in

the selected areas A2 to A5.

The process involved:

• Discussion with panel of industry representatives to select type of indus-

tries relevant for the assessment;



• Selection of 100 companies which has been estimate to be most relevant

with respect to the use of the substance in question - pre-survey meeting

with industry representatives to determine the selection;

• Survey including 216 substances covering the A2 to A5 areas;

• Response rate of 94 per cent;

• The results are indications of the maximum stock of each of the substances

for all 94 companies; and

• The survey allows for assessing each of areas, each substance and also to

apply the aggregation rule for all the substances included in the selected

areas.

The findings were analysed to inform the impact assessment. The following

reservations apply to the survey:

• The survey only covers one Member State;

• The companies included are considered to be representative, though it is

not possible to make a statistical assessment of the representativeness;

• The respondents include also non-Seveso II sites but may be less represen-

tative of non-Seveso II sites;

• The substances considered are only a subset of all relevant substance and

mixtures.

Despite these reservations, the survey provides an opportunity to make a quan-

titative analysis of the impact on the number of establishments, which is the

key parameter for evaluation of the impact of the alternative options for transla-

tion of the health categories into GHS.

45 per cent of establishments belong to the upper tier category, 20 per cent are

in the lower tier category, and the rest - 35 per cent - are non-Seveso II estab-

lishments.



Table 5-26 Description of industry survey

Category No of establishments %

Upper tier 42 45%

Lower tier 19 20%

Non Seveso II 14 15%

No information but likely to be non Seveso II 7 7%

Do not store any substance 12 13%

Total number of establishments 94 100%

Source: Ministère de l'Ecologie, de l'Energie, du Développement durable et de la Mer

Table 5-18 shows the number of establishments using the substances in each of

the areas above the Seveso II upper and lower tier thresholds.

The table shows that based on this sample there is no widespread use of sub-

stances in the area A2b. In A2, the use is more widespread pointing to an option

that includes the entire Acute 3 under the oral exposure route.

For the dermal exposure routes A3 and A4, the survey indicates that leaving A3

out would imply a minor reduction in scope, while including A4 would lead to

a significant increase in scope.

Finally, the area A5 is very toxic being translated into Acute 1 leaving area A5

out of the T+ category. The substances in A5 will be part of T as they are Acute

2 but the thresholds for both upper and lower tiers are higher, from 5/20 to

50/200 tonnes. The change in threshold values seems to have a significant im-

pact on the number of establishments falling under the lower and upper thresh-

olds. This impact is caused by many establishments using the substances in

volumes between 5 and 50 tonnes.

It should be noted that the description in Table 5-18 is based on the use of the

substances in each area. As establishments use other substance not included in

the survey, they might be Seveso II establishments even if they only use limited

volumes of the A2 to A5 substances.



Table 5-27 Use of identified substances

Area Tonnes Below thresholds

Lower Tier

Higher Tier

Total no. of establishments using sub-stance

A2 379 38 1 0 39

A2b 6,149 57 11 4 72

A3 2,289 28 4 1 33

A4 31,474 56 21 7 84

A5 as T+ 20,159 54 24 19 97

A5 as T 20,159 54 10 6 70

Source: Ministère de l'Ecologie, de l'Energie, du Développement durable et de la Mer and

consultant's calculations

Using these data and the aggregation rule it is possible to analyse the alternative

options for the translation of the health hazards.

Table 5-28 Impact of alternative options on number of establishments

Option Non-Seveso Lower Tier Upper Tier

Current Seveso II (incl. A2, A3, A5 low thresholds, A6) 56 8 18

Option A (incl. A2, A3, A5 low thresholds, A6) 56 8 18

Option B (incl. A2, A2b, A5 high thresholds) 72 4 6

Option C (incl. A2, A2b, A5 high thresholds, A6, A7) 61 14 7

Option D (incl. A2, A2b, A3, A4, A5 high thresholds, A6, A7) 46 17 19

Note: Options 2 and 3 will be similar in this survey as it does not include any of the A6 and

A7 substances.



The calculations show that compared to the current situation, most options will

reduce the scope due to the effect of A5, the inhalation aerosol exposure route

with LC50 values between 0.05mg/l and 0.25 mg/l, now being under T qualify-

ing quantities of 50/200 instead of 5/20 tonnes.

Option A denotes the alignment requiring a screening tool to determine the ex-

clusion of A2b and the inclusion of A3. Options 2 and 3 include A2b and ex-

clude A3. Option D is the more precautionary route that includes A3 and A4.

Option D will increase the scope compared to the other options by including A4

covering substances that are generally of no concern.

A5 includes about 26 substances of which sulphuric acid accounts for more

than 90 per cent of the volume in this survey. If this substance is included as a

named substance maintaining its current thresholds of 5/20 tonnes, the impact

on scope is reduced. The table below shows the effect of this modification.



Table 5-29 Impact of alternative options on number of establishments

Option Non-Seveso Lower Tier Upper Tier

Current Seveso (incl. A2, A3, A5 low thresholds, A6) 56 8 18

Option A (incl. A2, A3, A5 high thresholds, A6) 56 8 18

Option B (incl. A2, A2b, A5 high thresholds) 64 4 14

Option C (incl. A2, A2b, A5 low thresholds, A6, A7) 59 8 15

Option D (incl. A2, A2b, A3, A4, A5 high thresholds, A6, A7) 46 15 21

Note: Options 2 and 3 will be similar in this survey as they do not include any of the A6

and A7 substances.



In order to eliminate the effect of area A5 changing to the higher qualifying

quantities, more named substances are required. In the specific case of this sur-

vey, additionally 8 substances should be included in the named list (see Table

5-6 where they are indicated) based on the total volumes applied in the sur-

veyed companies being above 5 tonnes. These substances are additional to the

ones identifying as most important in the general questionnaire survey (also

presented in Table 5-6).

The results of the survey do in general confirm the results of the questionnaire.

The key findings from the French industry survey are:

• The prepossessed alignment for T+ with Acute 1 could potentially reduce

the scope with regard to the inhalation aerosol exposure route;

• Naming some of substances that change from T+ to T thresholds could

mitigate some of the decrease in scope;

• The area A2b which is included in Option C does not seem to increase

scope very much opposite to what was the indication in the other survey;

• Option D with precautionary alignment of T with Acute 3 for all exposure

routes seems to increase scope;

The reservations relating to the findings include first of all the fact that estab-

lishments might be included in the scope based on other substance or based on

physical-chemical or environmental hazards. The above results are therefore

most relevant as indicators of the differences between options.

Though there are differences with respect to the results of industry survey and

the broader and more qualitative questionnaire, the use of the indicator based

on the questionnaire is supported. The differences also illustrate that there are

variations in use patterns across Member States.



6 Other hazards and issues in translation

6.1 Other hazards

Annex I Part 2 to Seveso II includes one entry, category 10((i) and (ii)), which

is not covered by the aggregation rule in Note 4:

• 10. ANY CLASSIFICATION not covered by those given above in combi-

nation with risk phrases:

(i) R14: 'Reacts violently with water' (including R14/15)

(ii) R29: 'in contact with water, liberates toxic gas'.

The TWG has during its 6th meeting in November 2009 suggested moving

10(i) as a separate entry to the group of health hazards and 10(ii) as a separate

entry to the group of physical hazards and also included these entries in the ag-

gregation rule.

This means that the scope is widened with regard to the aggregation rule. As

this was introduced late in the process and just before finalisation of this report

it has not been possible to carry out a detailed assessment of the potential im-

pact of this change.

When checking the CAS numbers against Annex VI Table 3.1 in Regulation

1272/2008, 41 substances can be identified which are assigned EUH014. Of

these substances 26 are covered by other entries and out of the 26 substances, 7

have higher thresholds. In the Nordic SPIN database information is confidential

for 7 substances indicating a low number of establishments. With regard to the

remaining substances, only one is registered in more than 1000 kg and only in

one of the Nordic countries. Most of the 26 substances are only registered in

one or two countries.

A similar check for EUH029 identified 13 substances in Annex VI Table 3.1 in

Regulation 1272/2008 of which 12 substances were covered by other entries

with lower thresholds. The remaining substance was also assigned EUH014. In

SPIN this was registered in one country in more that 1000 kg but less than 5000

kg in 2007.



Data from the SPIN database does therefore not indicate any significant impact

on establishments in the Nordic countries of including this classification in the

aggregation rule.


In terms of the environmental hazard categories, a one-to-one translation is in

principle achieved with no impacts on substances classified as N; R50 and N;

R51/53.

• For some substances the classification may change



• In general the scope is expected to remain unchanged.

6.3 Mixtures

In the Seveso II Directive the definition of dangerous substances is as follows:

"dangerous substances shall mean a substance, mixture or preparation listed

in Annex 1, Part 1, or fulfilling the criteria laid down in Annex 1, Part 2, and

present as a raw material, product, by-product, residue or intermediate, includ-

ing those substances which it is reasonable to suppose may be generated in the

event of accident".

In Annex I it is further explained that "Mixtures and preparations shall be

treated in the same way as pure substances provided they remain within con-

centration limits set according to their properties under the relevant Directives

given in Part 2, Note 1, or their latest adaptation to technical progress, unless a

percentage composition or other description is specifically given".

The classification of mixtures according to CLP (GHS) can be more strict or

less strict than the classification according to the Preparations Directive.





In a report on the potential Effects of the Proposed GHS Regulation from the

Commission Services from 200648 some of the issues related to mixtures are

referred:

• The number of mixtures within a defined LD50/LC50 range may change,

depending on the method used to derive the classification under CLP

(GHS). Migration of individual mixtures to lower or upper toxicity ranges

48 Analysis of the Potential Effects of the Proposed GHS Regulation on Its Downstream

Legislation, Commission Services, August 2006



may occur. (Mixtures can be classified based on calculation rules (deviat-

ing from DPD), test results (similar to DPD) and bridging principles allow-

ing the classification of mixtures on the basis of data on similar tested mix-tures and information on individual hazardous ingredient substances.)

• When calculating the classification of a mixture with unknown ingredients

using the formula 3.1.3.6.2.3 for the calculation, the result will be more se-

vere the higher the percentage of unknown ingredients. This can also result

in mixtures being classified which were not classified under DPD. It is

however expected that this situation will be resolved over the years when

sufficient information on the ingredients is available and the additivity

formula in 3.1.3.6.1 can be used.

The UK HSE has made a study on some mixture examples demonstrating ex-

amples of resulting reduction and scope and the opposite:

The scope and/or regulatory attention could potentially be reduced for sites

holding mixtures containing:

• Ingredients classified as GHS Acute Tox. 1 with LD(C)50 values close to

GHS classification boundary and with concentration(s) above, but close to,

the 7% (non-gaseous ingredients) or 1% (gaseous) concentration limit or

• Ingredients classification as Acute Tox. 2 with LD(C)50 values close to up-

per classification boundary and with concentration(s) greater than but close

to the 25% (non-gaseous) or 5% (gaseous) concentration limit or.

• Acute Tox. 3 oral or inhalation as dust/mist ingredients LD(C)50 values

close to upper classification boundary and with concentration(s) greater

than but close to the 25% (non-gaseous) or 5% (gaseous) concentration

limit.

The scope and/or regulatory attention could potentially be increased for sites

holding mixtures containing:

• Non-gaseous Acute Tox. 1 ingredients present at <7% and with very low

LD(C)50 values (<0.35 mg/kg for the oral route, <3.5 mg/kg for the dermal

route, <0.035 mg/l/4h for inhalation of vapours, <0.035 mg/l/4h for inhala-

tion of dusts/mists) or

• Gaseous Acute Tox. 1 ingredients present at <1% and with an LC50 value

of <1 ppm/4h.

Acute Tox. 3 oral ingredients present at <25% and with LD50 values in the

range 50 – 75 mg/kg. The general conclusion is however, that it is not very

likely that the CLP regulation should lead to an increase in scope and/or regula-

tory attention as a result of the mixture rules introduced with CLP.

However, a modification in the environmental classification, not related to

alignment options, has caused some concern. This is due to the removal of ge-



neric concentration limits for classification of mixtures containing environmen-

tally hazardous substances and introduction of multiplying factors (M-factors)

for highly toxic components of mixtures. (Generic concentration limits (25%,

2.5% and 0.25%) were introduced by the DPD to define classification of the

preparation based on the concentration of the individual substances and their

environmental classification.)

'M-factor' means a multiplying factor. It is applied to the concentration of a

substance classified as hazardous to the aquatic environment acute category 1

or chronic category 1, and is used to derive by the summation method the clas-

sification of a mixture in which the substance is present. The concept of M-

factors has been established to give increased weight to substances that are

classified as very toxic for the aquatic environment when classifying mixtures

containing these substances. It is estimated that 20 - 40 substances are affected

in terms of classification of mixtures that contain them49.

6.3.1 Sodium hypochlorite

The case of sodium hypochlorite has been brought forward by the industry. An

industry survey has shown that potentially, a number of companies could be

affected of the modification in the classification.

In case of sodium hypochlorite, which has a concentration limit of 25 per cent

according to DSD, the CLP introduced M-factor will result in a classification of

the mixture already at 2.5 per cent active chlorine based on M-factor 10.

The reason for the possible reduction of the concentration limit could instead of

being the result of the M-factor approach be the results of a general re-

classification of the substance due to new test data on the effects.

Assessment The inclusion of additional sites is not related to any translation option.

However, an alternative alignment option that could be applied would be to

give this substance a specific entry.

Table 6-1 Alternative alignments for sodium hypochlorite

Advantages Disadvantages

Do nothing No additional adminis-

trative effort

Potentially many new sites

and with limited major

accident hazard potential

Create separate entry Maintain current scope Administrative costs

49 Enhesa Flash 48 - July 2009.



AISE has estimated that between 20 and 130 new establishments will be af-

fected by changes to the Seveso II Directive. This is a potentially high number

of additional sites. According to industry many of these sites will be ones that

stores sodium hypochlorite in small containers.

The issue of how to treat sodium hypochlorite will be further investigated in the

impact assessment of options for amending the Seveso II Directive50.

6.3.2 Conclusion on mixtures and solutions

The classification of mixtures according to CLP (GHS) can be stricter or less

strict than the classification according to the Preparations Directive.





The investigation of the impact of CLP on classification of mixtures and how it

will affect Seveso II indicates that scope can be change in either direction.

The rules for classification of mixtures are quite complex but example on both

more and less stringent classifications have been found.

The fact that when there is no data on one substance that is used in a mixture,

then the classification is more strict, means that as REACH over time will in-

crease the knowledge of substances, mixture classifications are likely to move

from strict to less strict classifications over time. In the impact study of intro-

ducing the GHS, it was estimated that by 2015 only around 33% of all mixtures

would be correctly classified51.

50 Based an general review of the Directive, the European Commission is considering alter-

native options to amend the Directive. A study to support the impact assessment and where

the sodium hypochlorite issue will be covered is expected later in 2010. 51 RPA (2006) Impact Assessment of Implementing the GHS: Work Package 1



7 Conclusions

The Seveso II Directive is potentially the piece of EU legislation which is most

affected by the change in classification criteria introduced with the CLP Regu-

lation of 16 December 2008 (1272/2008/EC). With a limited list of named sub-

stances the coverage of the Directive is largely determined by the generic clas-

sification categories for substances and preparations outlined in the Substance

Directive (DSD) (67/548/EEC) and the Preparations Directive (DPD)

(1999/45/EC). With the minimum classification applied when translating An-

nex I to the DSD to Annex VI table 3.1 in the CLP not all substances hazardous

to health are categorised correctly according to their toxicological properties

and this may result in reduced regular attention under Seveso II or even that

some establishments will fall out of scope.

Identification of possible options for aligning the criteria for classification and

the classification categories with the CLP has been closely linked to the discus-

sions in the Technical Working Group on Seveso II and GHS. Furthermore,

input from the participants with regard to identification of the most important

substances relevant for the industry and likely to be affected by the change has

provided valuable input for the impact assessment.

The goal is to maintain the scope and regular attention of the Directive to the

extent possible as well as the level of protection - while maintaining the generic

classification categories intact. The options addressed in the impact assessment

have therefore been selected considering the hazard potential of the substances,

their relevance for industry, the quantities used and the number of establish-

ments likely to be covered by the requirements.

The impact assessment is summarised in the below table.

Table 7-1 Generic impact assessment steps

1. Identifying the Problem Brief answers/comments

Describe the nature and extent

of the problem

The Seveso II Directive sets up rules for the safety in relation to major

accident hazards at industrial sites across EU. The classification system

for substances and mixtures are being changed and therefore the prob-

lem is: How to adapt the Annex I of the Seveso II Directive to the new EU

classification system for substances and mixtures - the CLP legislation.

See Chapter 2 for details on Seveso II and CLP

Identify the key players and af- About 9725 Seveso II regulated installations (e.g. companies using dan-



fected population gerous substances in production, manufacturers of dangerous sub-

stances, warehouses where substances are stored, etc.)

The potentially increased number of industrial establishments that might

fall under a revised Seveso II Directive

International manufacturers of Seveso II regulated substances as they

will have to comply with EU legislation

National Seveso II regulators and enforcement bodies

EU citizens if there are changes to the protection level and similarly for

the environment and eco systems, where changes to the protection level

could impact.

See Chapter 2 for details on Seveso II establishments

Establishing the drivers and un-

derlying causes

Alignment to the International GHS classification system which is used as

basis for classification in related Legislation such as REACH. The GHS

has been implemented into EU law through the CLP Regulation (EC) No

1272/2008 on Classification, labelling and packaging of substances and

mixtures from 16 December 2008.

See Chapter 2 for details on CLP and GHS

Is the problem in the Union's

remit to act? Does it pass the

necessity and value added test?

Yes it makes sense to harmonise at the EU level with the CLP which is

EU level legislation for classification.

Develop a clear baseline A baseline in the traditional understanding can not be defined. As the

basis for the current Seveso II classification will cease to exist in the fu-

ture one of the specific options for adopting Annex 1 to the GLS has to be

selected. The current Seveso II legislation will be used to define current

scope of the Directive so all options are assessed against current scope.

2. Define the objectives Brief answers/comments

Set objectives that correspond

to the problem and its root

causes

The Seveso adaptation to GHS will as a minimum have the objective to

remain status quo in terms of 'the prevention of major accidents which

involve dangerous substances, and the limitation of their consequences

for man and the environment, with a view to ensuring high levels of pro-

tection throughout the Community in a consistent and effective manner.'

See Chapter 2.1. Background and objectives

Establish objectives at a number

of levels from general to specific

To reduce the risk of major accidents through implementation of preven-

tive measures related to handling and storage of dangerous substances.

In case of accidents to reduce the impact and consequences for man and

environment through prevention measures.

Specifically:

• to ensure that the swift of reference from the current EU legisla-

tion to the CLP regulation does not by any means narrow the

scope of the Seveso II

• to ensure that the alignment , meaning the level of protection

should be maintained

• the scope to be kept as close as possible to the existing EU sys-

tem

• the new Annex should be easily manageable in the long term,

e.g. CLP categories should be kept intact

See Chapter 2.1. Background and objectives and Chapter 3.

Ensure if objectives are coher-

ent with existing EU policies and

Relevant EU policies and strategies:

• EU Sustainable Development Strategy (EU SDS), concerning



strategies 'sustainable consumptions & production, conservation and man-

agement of natural resources, public health

• Integrated Product Policy

• Waste Policies

• Transport of dangerous substances

• Occupational health and safety

• Integrated Pollution and Prevention Control Directive (IPPC)

See Chapter 2.1. Background and objectives

3. Develop main policy options Brief answers/comments

Identify policy options (content

and delivery mechanisms)

It is with regard to health hazards that alternative options need to be con-

sidered, while most other Seveso categories can be translated into CLP

in one to one alignments. The main choice is between alignments options

that:

• Use a screening approach/tool to effectively maintain scope

• Use fewer CPL categories leading to a reduction in scope which is

potentially can be compensated with named substances or

• Use more CLP categories leading to a potential increase in scope

Check the proportionality princi-

ple

Na

Begin to narrow down the range

through screening for technical

and other constraints, and

measuring against criteria of

effectiveness, efficiency and

coherence

The assessment of options includes all relevant generic options and

through a screening based on efficiency criteria which focus the number

of options by removing the options leading to most significant deviation

from current scope without offering other benefits.

Draw up a shortlist of potentially

valid options for further analysis

The short list includes four options for health hazard categories and the

preferred option for other categories. For the majority of categories no

options are defined as the alignment is one to one.

4. Analyse the impacts of the

options

Brief answers/comments

Identify direct and indirect eco-

nomic, social and environmental

impacts and how they occur

(causality)

The economic impacts are additional costs to industry from potentially

review of Seveso status and for new establishments coming into scope.

The costs include the administrative costs of becoming a Seveso site.

Costs of physical modifications of the site have not been estimated.

Health (social effects) and environmental effects are related to the protec-

tion level.

Identify who is affected (also

outside EU) and in which way

All industry sectors currently regulated by Seveso could be affected - no

new sectors have been identified.

Assess the impacts against the

baseline in qualitative and as far

as possible in quantitative and

monetary terms

Economic impacts have been quantified; health and environmental im-

pacts are only qualitatively described. The range of most likely economic

impacts is additional costs in the range of EU 2-5 million per year.

Identify and assess administra-

tive burden/simplification bene-

fits

The estimated economic impacts are mainly increased administrative

burdens.

Consider the risks and uncer-

tainties in the policy choices,

including obstacles to transposi-

tion/compliance

The assessment is based on few quantitative data. There is limited

knowledge about how many establishments will be affected and a rough

indicator approach has been applied.



5. Compare the options Brief answers/comments

Weigh-up the positive and nega-

tive impacts for each options on

the basis of the criteria clearly

linked to the objectives

The advantages and disadvantages of the alternative options have been

described.

The choice of option depends on whether an amended derogation rule

would be introduced. An amended derogation rule would allow for exclud-

ing substances that has no major accident hazard potential.

Where feasible display aggre-

gated and disaggregated results

Data is presented aggregated for the EU27. Best estimate for the impact

on individual Member States is by apportioning the total costs by share of

establishments in each Member State.

Present comparisons between

options by categories of impacts

of affected stakeholders

The advantages and disadvantages of the alternative options have been

described.

Identify, where possible and

appropriate, a preferred option

An option called Option C has been identified as the preferred option in

scenario whether the derogation rule is not amended. If the derogation

rule is amended, Option D which is a simple alignment that translate T

with Acute Toxicity Category 2 and 3.

6. Outline policy monitoring and

evaluation

Brief answers/comments

Identify core progress indicators

for the key objectives of the

possible intervention

Not considered relevant for the translation of the Seveso II Directive into

the GHS. This is only relevant for the directive as such and will not be

considered in this impact assessment.

Provide a broad outline of pos-

sible monitoring and evaluation

arrangements

Not considered relevant for the translation of the Seveso II Directive into

the GHS. This is only relevant for the directive as such and will not be

considered in this impact assessment.

7.1 Options by category

Most of the categories in Annex 1 can be adapted to the CLP with limited or

not change in scope. Table 5.1 presents an overview of all categories. The sub-

sequent sections describe the detailed impact assessment category by category.

For the hazards where no change in scope or in regulatory attention is expected,

a qualitative assessment has been made. A more comprehensive assessment has

been developed for aerosols and health hazards.

Table 7-2 Overview of alignments by category

Hazard category

Category Articles 6 & 7 Article 9 Change in scope

PHYSICAL HAZARDS

P1 OXIDIZING GASES

Oxidising gases, Category 1 50 tonnes 200 tonnes No change

P2 OXIDIZING LIQUIDS AND SOLIDS

Oxidising Liquids Category 1, 2 or 3, or

Oxidising solids, Category 1, 2 and 3

50 tonnes 200 tonnes Slight increase in scope



P3 EXPLOSIVES (see note 2)

- Unstable explosives or

- Explosives, Division 1.1, 1.2, 1.3, 1.5 or 1.6,

or

- Substance or mixture having explosive prop-

erties according to method A.14 of Regulation

EC No 440/200852 (see note 3) and do not

belong to the hazard classes Organic peroxides

or Self-reactive substances or mixtures

10 tonnes 50 tonnes No change

P4 EXPLOSIVES (see note 2)

Explosives, Division 1.4 (See note 4) 50 tonnes 200 tonnes No significant change

P5 FLAMMABLE GASES

Flammable gases, Category 1 or 2 10 tonnes 50 tonnes No change

P6 Flammable AEROSOLS *(see note 5.1)

“Extremely flammable” or “Flammable” aero-

sols, containing flammable gases

150 tonnes 500 tonnes Moderate change, see specific

assessment

P7 FLAMMABLE AEROSOLS *(see note 5.1)

“Extremely flammable” or “Flammable” aero-

sols, not containing flammable gases nor

flammable liquids category 1

5000 tonnes 50000 tonnes Moderate change, see specific

assessment

P8 FLAMMABLE LIQUIDS

- Flammable liquids, Category 1 or

- Flammable liquids, Category 2 or 3 main-

tained at a temperature above their boiling

point, (see note 6)

10 tonnes 50 tonnes No significant change


- Flammable liquids, Category 2 or 3 where

particular processing conditions, such as high

pressure or high temperature may create major-

accident hazards, or

- Other liquids with a flash point ≤ 60°C,

where particular processing conditions, such as

high pressure or high temperature, may create

major-accident hazards (see note 6)



Flammable liquids, Categories 2 or 3not cov-

ered by P8 and P9

5.000 tonnes 50.000 tonnes No significant change

P11 SELF-REACTIVE SUBSTANCES AND

MIXTURES and ORGANIC PEROXIDES

Self-reactive substances and mixtures, Type A

or B or


52 Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation

(EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evalua-

tion, Authorisation and Restriction of Chemicals (REACH)



organic peroxides, Type A or B

P12 SELF-REACTIVE SUBSTANCES AND

MIXTURES and ORGANIC PEROXIDES

Self-reactive substances and mixtures, Type C,

D, E or F or

organic peroxides, Type C, D, E, or F

50 tonnes 200 tonnes Decrease in scope for Type C

P13 PYROPHORIC LIQUIDS

Pyrophoric liquids, Category 1 50 tonnes 200 tonnes No change

P14 - Substances and mixtures with hazard state-

ment EUH014 100 tonnes 500 tonnes No significant change expected

PYROPHORIC SOLIDS

Pyrophoric solids, Category 1 It was agreed during the 6th TWG meeting not to include pyrophoric substances.

HEALTH HAZARDS

Option A: Simple alignment with screening tool

H1 ACUTE TOXIC

Acute toxic - category 1

Compensation: named substances

5 tonnes 20 tonnes

General:

Oral: →

Dermal: →

Inhal, vapour: →

Inhal, dust: →↓

Inhal, gas: →

H2 ACUTE TOXIC



General:

Oral: →

Dermal: →

Inhal, vapour: →

Inhal, dust: →

Inhal, gas: →

ACUTE TOXIC

Acute toxic - category 3 50 tonnes 200 tonnes Screening tool

Option B: Simple alignment

H1 ACUTE TOXIC

Acute toxic, category 1

Named substances for oral and inhalation

exposure routes

5 tonnes 20 tonnes

General:

Oral: ↓

Dermal: →

Inhal, vapour: →

Inhal, dust: ↓

Inhal, gas: →

H2 ACUTE TOXIC


Acute toxic - category 3 only for inhalation

aerosol exposure route


General:

Oral: ↓

Dermal: ↓

Inhal, vapour: →

Inhal, dust: →



Named substances for oral, dermal and

inhalation exposure routes

Inhal, gas: ↓

Option C Central option

H1 ACUTE TOXIC



exposure routes

5 tonnes 20 tonnes

General:

Oral: ↓

Dermal: →

Inhal, vapour: →

Inhal, dust: ↓

Inhal, gas: →

H2 ACUTE TOXIC


Acute toxic - category 3 only for inhalation

aerosol exposure route


General:

Oral: ↓

Dermal: ↓

Inhal, vapour: →

Inhal, dust: →

Inhal, gas: ↓

Option D Precautionary alignment

H1 ACUTE TOXIC



exposure routes

5 tonnes 20 tonnes

General:

Oral: ↓

Dermal: →

Inhal, vapour: →

Inhal, dust: ↓

Inhal, gas: →

H2 ACUTE TOXIC


Acute toxic - category 3 50 tonnes 200 tonnes

General:

Oral: ↓

Dermal: ↑

Inhal, vapour:↑

Inhal, dust: ↑

Inhal, gas: →

STOT

H3 SPECIFIC TARGET ORGAN TOXICITY -

Single Exposure

STOT Category 1


H4 - Substances and mixtures with hazard state-ment EUH029

50 tonnes 200 tonnes No significant change expected

ENVIRONMENT

E1 Hazardous to the aquatic environment in cate-

gory

Acute 1 or Chronic 1

100 tonnes 200 tones No change

E2 Hazardous to the aquatic environment in cate-

gory

Chronic 2




7.2 Physical hazards

Aerosols Regarding alternative alignment for categories related to the physical hazards

the main issue is with aerosols. The analysis of aerosols has shown:

• An estimate of the one-to-one translation based on average LPG or flam-

mable propellant content has indicated a level around 38 per cent. This is

used to convert the LPG thresholds of 50/200 into aerosol thresholds of

150 and 500 tonnes.

• Surveys of the impact of the options with 150/500 tonnes based on total

aerosols quantify indicates either a small decrease or increase in scope.

• Some establishments will fall outside the scope and some will fall inside

the scope compared to the current situation

• Overall, no major changes to the scope are expected



ard potential or not

• Overall, it is concluded that impact of the proposed translation is limited,

though there could be new installations coming under Seveso II.


In terms of the environmental hazard categories, a one-to-one translation is in

principle achieved with no impacts on substances classified as N; R50 and N;

R51/53.

• For some substances the classification may change



• In general the scope is expected to remain unchanged.

7.4 Health hazard options

For health hazards, the classifications according to the DSD includes the cate-

gories of toxic (T) and very toxic (T+). The CLP legislation includes the cate-

gories of Acute Toxicity Category 1 to Category 4 (hereafter called Acute 1 to

Acute 4).

Simple alignments The simple alignments would include two alternatives, one where T is

translated by Acute 2 and one where T is translated into Acute 2 and 3, while

T+ in both alternatives is translated by Acute 1.



The two simple alignments have some significant drawback. If T is translated

by Acute 2 only, then it means a reduction in scope. The other simple align-

ment with T translated by Acute 2 and 3 would on the other hand results in an

increase in scope.

A number of approaches to mitigate the change in scope that results from the

simple alignments have been assessed. They include:

• Differentiated exposure routes (include or exclude the CLP categories by

the five exposures routes: oral, dermal and inhalation (vapour, aerosols and

gas));

• Named substances (include the most important substances in Annex I Part

1);

• Screening tool (screen substances in if they are within the T+ and T

boundaries based on LD50/LC50 values);

• Amend the derogation rule and safety clause so that substances can be ex-

cluded or included based on criteria for the major accident hazard poten-

tial)

Final options The alternative mitigation options could be combined to large number of

alternative alignment alternatives for the health hazards. Through a process of

assessing the each of the mitigation approaches and the simple alignment op-

tions, four key options have been defined. These options are illustrated at Fig-

ure 1-2 below.

Mitigation of scope

change




IA Option A to D

T+ T XnEU

1 2 3 4Oral

mg/kg

1 2 3 4inhal.

vapour

mg/l

inhal.

aerosol

mg/l

1 2 3 4

2 3 4inhal. gas

mg/l

ppm

1 32 4Dermal

mg/kg

0 25 200

0 5 25 50 200 300

0

0,1

0

0

0

0,5

0,5 2 2.5

2

20050 400 1000

0,50,05 0,25 1

500 2000 25001000

10

Boundary

to old

legislation

1

A1 A2

A5a

A3

A7A6

A4

A2b


T+ T

A5b

A8

The assessment of the options has described in Chapter 5 are summarised in the

below table.

There is no simple conclusion as there are advantages and disadvantages asso-

ciated with each option. The overall conclusion is likely to depend very much

on whether an amended derogation rule and a safeguard clause are introduced.

If an amended derogating rule would be introduced, Option D seems to be most

favourable. It will prevent any decrease in scope and if there would be an in-

crease where new sites will be brought in though they represent no major acci-

dent hazard potential, the derogation rule can prevent that from happening.

For the translation of T+ with Acute 1, the possible decrease in scope that re-

sults from the inhalation aerosol uptake route, the safeguard clause could mean

that if establishments are to fall out of scope they can be kept in.

The administrative costs are the least with this option as it is using a simple

alignment. The derogation process can resource demanding but it will only be

used if in situations where there is risk a significant increase and then by avoid-

ing unwanted increase in scope, it prevents additional costs.

Assessment of

impacts

With derogation rule

and safeguard clause



Table 7-3 Overall assessment of health options

Option Description Scope and

regulatory attention

Administrative

effort

Protection level

Option A Screening tool approach for boundary

areas of T+ and T

Maintain scope but

may discriminate

between existing

and new substances

Higher than other

options due to the

screening approach

No change com-

pared to current

level

Option B T+ to Acute 1 plus named substances

for missing Acute 2 areas

T to Acute 2 and Acute 3 for inhala-

tion aerosol


3 areas

Reduction in scope

- depend on degree

of compensation by

named substances

Slightly higher due

to differentiated

exposure routes

Protection level

varies with scope -

possible reduction

Option C T+ to Acute 1 plus named substances


T to Acute 2 plus Acute 3 for oral

and inhalation (aerosol and gas)


3 area in dermal exposure route

Possible increase in

scope from more T

substance but re-

duction in scope

from T+ substances

having higher

thresholds

Slightly higher due

to differentiated

exposure routes

Protection level

varies with scope -

possible increase

Option D T+ to Acute 1 plus named substances


T to Acute 2 plus Acute 3 for all

uptake routes

Increase in scope No change com-

pared to current

level

Protection level

varies with scope -

increase

Without the derogation rule, Option D could lead to significant increase in

scope. Under this scenario, Option C - possibly in the variant C* where T+ is

translated into Acute 1 and 2 for the inhalation aerosol uptake route - seems

most favourable. Option C is reasonable close to the current scope, though it

could lead to an increase in scope with regards to the oral exposures route and

small decrease with the dermal route.

The difference between having the derogation rule in place or not is illustrated

in the next two tables. They summarise the key elements of the assessment of

the options.

Table 7-4 Overview of impacts of alternative alignment options - no derogation

rule/safety clause

Scope (short term) Scope (long term) Administrative costs Protection level

Option A No change Reduced High No change

Option B Reduced Reduced Medium Reduced

Option C Slightly decreased Reduced Medium Slightly increased

Option D Increased Increased Low Increased

Without derogation

rule and safeguard

clause



With no derogation rule/safety clause, Option C is the most preferred option.

The reduction in scope in the short term could be partly mitigated with named

substances. Option D risks leading to a significant increase scope.

With an amended derogation rule/safety clause, it assumed that the changes in

scope can be avoided and as Option D has low administrative costs because it

does not differentiate by exposures routes and protect against future reductions

in scope, this option is the most preferred option.

Table 7-5 Overview of impacts of alternative alignment options - with derogation

rule/safety clause

Scope (short term) Scope (long term) Administrative costs Protection level (long

term)

Option A No change Reduced High Reduced

Option B No change Reduced Medium Reduced

Option C No change Reduced Medium Reduced

Option D No change No change Low No change

In terms of protection level, the options vary in proportion to scope. If the op-

tion leads to a reduction in scope, the protection level is likely to be reduced

and if scope is increased so is the protection level. This assessment is based on

the approach with a scoring of individual substances. This scoring shows that

areas A1 to A7 all includes both high and low scored substances. Therefore

when increasing scope and including more high scored substances (those with

higher major accident potential) also lead to a number of low scored substances

to be included.

The alternative options E and E* has been defined as result of the analysis of

Option A to D. They are different in that they differentiate between the main

uptake routes and include Acute Tox 3 for inhalation (and dermal)

In terms of impacts E and E* will be different from Option B to D as analysed

above as they will mean a combination of increased and decreased scope. There

will be more substances included from inhalation through the sub-exposure

routes vapour and gas, while there will be a reduction for the oral exposure

route.








Protection level

Impacts of Option E

and E*










7.5 Impacts of overall adaption of Annex 1

The impact of the translation and adaption of Annex 1 as such will depend on

the choice of alignments for the individual hazard categories.

7.5.1 Economic impacts

Based on the above assessment of options, the following economic impacts

have been identified:

Cost for industry:

• Overall costs for reviewing existing inventories and reviewing and under-

standing the new Annex 1. This cost element is common for all three haz-

ard groups.

• Physical hazards: Only minor changes no economic impacts has been iden-

tified apart from the case of aerosols.

• Environmental hazards: One to one translation and no economic impacts

identified.

• Health hazards: Alternative alignment options that require some adminis-

trative effort to implement and potentially change scope. Change in scope

means a change in the number of establishments covered by the obligations

of the directive. They will either save the administrative costs related to

compliance with the directive or they will have to pay these additional

costs.

Costs for the CA:

• One-off costs of adapting to a revised Annex I;

• Costs or savings related to change in number of establishments.

The costs are shown as annual costs. It is important to note that the estimated

values provide a rough order of magnitude estimate.



Table 7-6 Economic impacts - million EUR per year

Type of impact Estimated cost

impact on industry

Estimated cost impact on

CA53

General adaption to new Annex 1

One off adjustments and review of

substance inventories etc (total

costs)54

≈ 1.7 ≈ 0.4

Physical hazards

Change in scope due to aerosol option

(0-50 new establishments)

< 1 <0.1

Other categories No costs estimated No cost estimated

Environmental hazards No costs estimated No cost estimated

Health hazards

Administrative adaption (Option C or

D)

≈ 2 - 3 No cost estimated

Scope change (Option C or D) ≈ 0.5 - 4 ≈ 0.5

Total ≈ 5.2 - 9.7 ≈ 1

Source: Consultant's estimates

These cost estimates can be compared to the administrative costs of the Seveso

II Directive as presented in the recent study on administrative burdens of se-

lected EU directives. The study estimated the total annual administrative costs

for industry to about EUR 52 million. They can also be compared to the esti-

mated costs of the overall adaptation to the CLP due to re-classification, re-

labelling, changes to it systems etc. The costs of transition to the CLP have

been estimated to almost 500 million EUR.

Net and gross impacts Establishments that are already Seveso II sites might not experience much cost

savings as a result of the changed status. They have already invested in safety

reports, safety systems and emergency plans and in physical modifications if

that were necessary. They will only save future updates of the plans. In terms of

financial impacts on industry, there is likely to be asymmetric effects so the

cost savings for one establishment falling out of scope will not offset the addi-

tional costs for a new establishment coming into scope. The total aggregated

costs could therefore increase even if there is no net increase in the number of

establishments falling within scope.

53 The costs for CA in relation to scope changes are assumed to be around 10% of the cost

for industry per establishment for inspection etc. 54 One-off costs of 7.7 million EUR annualised over 5 years and a discount rate of 4%.

One-off costs for CAs at 1.8 million annualised over 5 years and 4%.

Costs in perspective



7.5.2 Environmental impacts

The environmental impacts are those related to the protection level and the en-

vironmental hazards. As the scope with respect to the environmental hazard

categories are estimated to be more or less unchanged, there are no environ-

mental impacts from adapting Annex 1 of the Seveso II Directive to CLP.

7.5.3 Social impacts

The potential social impacts (in accordance with the EU IA definitions) could

include health impacts and social knock-on effects from the economic impacts

on industry.

Health impacts The considerations of the protection level indicate very limited impacts for

most of the health hazard options. Options C or D more or less maintain the

current scope, and therefore they also leave the protection level unchanged.

Employment impacts It is not possible to apportion the costs for industry to specific industries. The

data on Seveso II establishments does not allow for that. Overall, the annual

costs estimated at a range of 5 to 10 million EUR would if they were divided

among the entire 9700 establishments amount to 500 to 1000 EUR per estab-

lishment. Though there could be specific sites that will experience one-off costs

that are sufficiently high to affect their profitability, overall the economic ef-

fects seems too be low. Therefore, no social effects, for example employment

impacts, can be identified.



Appendix A Questionnaire on substance for Member States

Questionnaire to Member States

Please assess the area 2b substances with respect to industrial importance and use.

For those assessed as important indicate which industries uses the susbtance and make judgement on the number of establishments.

Area 2b (Oral Cat 3 LD50 200-300 mg/kg) CAS number Industrial

importance of

substances

(1, 2 or 3)

Used in which

industries?

Many/some/few/n

ot known number

of

estiablishments

Comments

benzyldimethylamine 103-83-3

4-(Diethylamino)-2-butyn-1-ol 10575-25-4

m-cresol 108-39-4

N,N'-Methylenediacrylamide 110-26-9

Hexylamine 111-26-2

1-Methylpyrrolidine 120-94-5

(potassium hydroxide) 1310-58-3

9-[2-(Ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-

2,7-dimethylxanthylium ethyl sulphate 26694-69-9

3,7-Dihydro-1,3-dimethyl-1H-purine-2,6-dione, sodium3485-82-3

Phenethylamine 64-04-0

.alpha.,.alpha.-Bis[4-(dimethylamino)phenyl]-4-

(phenylamino)naphthalene-1-methanol 6786-83-0

1-Ethylpiperidine 766-09-6

Dibutyltin dilaurate 77-58-7

Sodium bromate 7789-38-0

Quinoline 91-22-5

3,4-Dimethoxyphenylacetonitrile 93-17-4

3-Methoxybenzenethiol 15570-12-4

Mangannitrat 10377-66-9

Cyclohexylamin 108-91-8

Ethylacrylat 140-88-5

Fenthion 55-38-9

Glycerol-alpha-Chlorhydrin 96-24-2

Other substance - insert name



Industrial importance of substance Important 1 High volume and/or many users

Maybe important 2 Medium volumes and some users

Not important 3 Small volumes and few users



Appendix B Member State and industry survey: Overview of results

Area A2:

T / Cat 3 oral

(LD50 50-200 mg/kg)

CAS num-

ber MS

1

MS

2

MS

3

MS

4

MS

5 MS 6

SPIN

data Industry

N,n'-di-sec-butyl-1,4-fenyleendiamine 101-96-2 3 3 3 3 3

Tributylamine 102-82-9 3 2 3 3 3

3-mercaptopropionic acid 107-96-0 3 2 3 3 3

1,4-Naphthoquinone - Several suppliers 130-15-4 3 2 3 3 3

Ethyltriphenylphosphonium acetate 35835-94-0 3 3 3 3 3

1,1'-(p-Tolylimino)dipropan-2-ol 38668-48-3 3 3 3 3 3

Thimerosal 54-64-8 3 3 3 3 3

Methyloranje 547-58-0 3 3 3 3 3

Methyl-p-benzoquinone 553-97-9 3 3 3 3 3

Triphenylstibine 603-36-1 3 3 3 3 3

o-Phthalaldehyde 643-79-8 3 3 3 3 3

Vanadiumoxytrichloride 7727-18-6 3 3 3 3 no data

Dibutyltin oxide 818-08-6 3 3 3 3 3

N,N-Dimethylbutylamine (N,N-dimethtyl-n-butylamine

ex. OXEA)

927-62-8 3 3 3 3 no data

B 109, 5% in styrene 3 3

Not

found no data

C5-Wittigester halogenide (C5WE) 3 3

Not

found no data

UNIREZ 550 (Inactive) 3 3

Not

found no data

N-(2-(4-amino-N-ethyl-m-

toluidino)ethyl)methaansulfonamidesesquisulfaat ? 3 3

Not

found no data

Natriumchloriet (bedoelen ze 'sodium chloride, CAS

7647-14-5) ? 1 1 1 1 no data

Rhodate(3-), tri-.mu.-bromohexabromodi-, tripotas-

sium ? 3 3

Not

found no data

Methanesulfonamide, N-[2-[(4-amino-3-methylphenyl)

ethylamino]ethyl]-,sulfate (2:3), dihydrate ? 3 3 3 no data

Epichlorohydrin 106-89-8 3 1 3 1 1 1 1

Cadmium oxide 1306-19-0 1

Dimethyl sulphate 77-78-1 1

Methylene bis(thiocyanate) 6317-18-6 2

Acrylamide 79-06-1 1

Methyl chloroacetate 96-34-4 1

Methyl iodide 74-88-4 1

Sodium nitrite 7632-00-0 1

Ammonium Dichromate (as Cr VI) 7789-09-05 1

Potassium dichromate 7778-50-9 2

Sodium chromate 7775-11-3 2

2, 3 - dichloropropene 542-75-6 2

1,2,3 - trichloropropane 96-18-4 2

Area 2b:

Xn / Cat 3 Oral

(LD50 200-300 mg/kg)

CAS num-

ber MS

1

MS

2

MS

3

MS

4

MS

5 MS 6

SPIN

data Industry

Methanesulfonamide, N-[2-[(4-amino-3-methylphenyl) ? 3 3 3 No data



ethylamino]ethyl]-,sulfate (2:3), dihydrate

Nickel sulfate hexahydrate 10101-97-0 3 2 1 2 1

Nickel(II)sulfate hexahydrate (1:1:6)

10101-97-

0? 3 2 1

4-Dimethylaminopyridine 1122-58-3 3 2 3 3 3

1,2-dihydroxybenzene; pyrocatechol ** 120-80-9 3 3 3 2 3

Potassium hydroxide 1310-58-3 1 1 3 1 1 1

Lithium hydroxide (anhydrous) 1310-65-2 3 3 3 2 2

Lithium hydroxide monohydrate 1310-66-3 3 3 2 3 3

Sodium sulphide 1313-82-2 2 3 3 1 1 1

Imidazole 288-32-4 3 2 3 3 3 3

Benzaldehyde, 2,4-dihydroxy-, oxime

349660-72-

6 3 3 3 No data

1,3-Propanediol, 2-bromo-2-nitro- 52-51-7 3 2 3 1 2 2

Ethyl-2-bromopropionate (BPE) 535-11-5 3 3 3

Not

found No data

Sodium thiocyanate (Component) 540-72-7 3 3 3 1 2

Trimethyl benzyl ammonium chloride 56-93-9 3 3 3 2 3

2-mercaptoethanol 60-24-2 3 2 3 2 No data

Aniline 62-53-3 3 1 3 1 3 1

Cyclohexanol, 2-amino- ** 6850-38-0

3 3

3 -

Not

found

No data

Cyclohexanol, 2-amino-, (1R,2R)-rel- ** 6982-39-4

3 3

3 -

Not

found

No data

didecyldimethylammonium chloride 7173-51-5 3 3 3 1 2 No data

2,2,2-trifluorethanol 75-89-8 3 3 3 3 No data

1,3-Dibromo-5,5-dimethylhydantoin 77-48-5 3 3 3 3 3

Sodium metaperiodate 7790-28-5 3 2 3 3 3

Jeffamine D-2000 9046-10-0 3 2 3 3 2

Methyl acrylate 96-33-3 3 1 3 1 3

Triethylborium 97-94-9 3 3 3 3 3

benzyldimethylamine 103-83-3 3 3 3 3 No data

4-(Diethylamino)-2-butyn-1-ol 10575-25-4 3 3 3 3 No data

m-cresol 108-39-4 3 1 3 1 2 1

N,N'-Methylenediacrylamide 110-26-9 3 3 3 3 3

Hexylamine 111-26-2 3 3 3 1 No data

1-Methylpyrrolidine 120-94-5 3 3 3 2 3

Potassium hydroxide 1310-58-3 1 1 3 1 - 1 No data

9-[2-(Ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-

dimethylxanthylium ethyl sulphate 26694-69-9 3 3 3 3

3,7-Dihydro-1,3-dimethyl-1H-purine-2,6-dione, sodium 3485-82-3 3 3 No data

Phenethylamine 64-04-0 3 3 3 No data

.alpha.,.alpha.-Bis[4-(dimethylamino)phenyl]-4-

(phenylamino)naphthalene-1-methanol 6786-83-0 3 3 3 3

1-Ethylpiperidine 766-09-6 3 3 3 No data

Dibutyltin dilaurate 77-58-7 3 2 3 3 3

Sodium bromate 7789-38-0 3 3 3 2 3

Quinoline 91-22-5 3 2 3 3 3 3

3,4-Dimethoxyphenylacetonitrile 93-17-4 3 3 3 3

3-Methoxybenzenethiol 15570-12-4 3 3 3 No data

Mangannitrat 10377-66-9 3 3 3 3



Cyclohexylamin 108-91-8 3 2 3 3 3

Ethylacrylat 140-88-5 3 1 3 1 2

Fenthion 55-38-9 3 2 3 2 No data

Glycerol-alpha-Chlorhydrin 96-24-2 3 3 3 2 2

Bis (chloromethyl) ether 542-88-1 3

Epichlorohydrin 106-89-8 1

Methyl bromide 74-83-9 2

Dimethyl disulphate 624-92-0 1

Bis (2-chloroethoxy) methane 111-91-1 2

Nickel sulphate 7786-81-4 2

Dicyclohexylamine 101-83-7 3

Dibutylamine 111-92-2 2

2 - chlorobuta- 1, 3 - diene 126-99-8 2

Area A3:

T / Cat 3 Dermal

(LD50 200-400 mg/kg)

CAS num-

ber MS

1

MS

2

MS

3

MS

4

MS

5 MS 6

SPIN

data Industry

2-methylpyridine; 2-picoline 109-06-8 3 3 2 3

Piperidine 110-89-4 3 2 2 3

Bis(2-dimethylaminoethyl)(methyl)amine 3030-47-5 3 3 2 2

3-(2-Ethylhexyloxy)propylamine 5397-31-9 3 3 3 3

1,1-dichloroethylene 75-35-4 3 3 3 2 2

Acrolein 107-02-8 2

Formaldehyde 50-00-0 1

Cyclohexamine 108-91-8 3

2 - chlorobuta -1, 3, - diene 126-99-8 2

Area A4:

Xn / Cat 3 Dermal

(LD50 400-1000 mg/kg)

CAS num-

ber MS

1

MS

2

MS

3

MS

4

MS

5 MS 6

SPIN

data Industry

Cyclohexanemethylamine 3218-02-8 3 3 3 No data

2-Aminoethyldiethylamine 100-36-7 3 3 3 3 No data

2-diethylaminoethanol; N,N-diethylethanolamine 100-37-8 3 2 3 2 2

Cyclohexyl(methyl)amine 100-60-7 3 3 3 3 3

4-Ethylmorpholine 100-74-3 3 3 3 3 3

Tripropylamine 102-69-2 3 3 3 3 3

Benzyldimethylamine 103-83-3 3 3 3 2 2

1-Naphthalenemethanamine, .alpha.-methyl-, (S)- 10420-89-0 3 3 3 No data

2-Ethylhexylamine 104-75-6 3 3 3 3 3

3-aminopropyldiethylamine; N,N-diethyl-1,3-

diaminopropane 104-78-9 3 3 3 3 3

Bis(2-ethylhexyl)amine 106-20-7 3 3 3 3 3

P-toluidine; 4-aminotoluene 106-49-0 3 3 3 3 3

Isobutyl acrylate 106-63-8 3 2 3 2 3

1-chloro-2,3-epoxypropane 106-89-8 3 2 3 1 1

2,3-epoxypropyl methacrylate; glycidyl methacrylate 106-91-2 3 3 3 1 3 3

Propylamine 107-10-8 3 2 3 3 3

Cyclohexylamine 108-91-8 3 2 3 3 3

Cyclohexanone 108-94-1 3 1 3 1 1 2

Phenol; carbolic acid; monohydroxybenzene; phenyl

alcohol 108-95-2 3 1 3 1 - 1 1

3-Methylpyridine 108-99-6 3 3 3 2 No data

butylamine 109-73-9 3 2 3 2 3



Malononitrile 109-77-3 3 3 3 3 3

Diethylamine 109-89-7 3 2 3 1 2

Pentylamine 110-58-7 3 3 3 3 3

But-2-yne-1,4-diol; 2-butyne-1,4-diol 110-65-6 3 2 3 3 3

Morpholine 110-91-8 3 2 3 1 2 2

Hexylamine 111-26-2 3 3 3 3 No data

Butyl isocyanate 111-36-4 3 3 3 2 3

2,2'-iminodiethylamine; diethylenetriamine 111-40-0 3 2 3 2 2

2-butoxyethanol; ethylene glycol monobutyl ether bu-

tyl cellosolve 111-76-2 3 1 3 1 1 1

Di-n-butylamine 111-92-2 3 3 3 2 3

3,6-diazaoctanethylenediamin; triethylenetetramine 112-24-3 3 2 3 2 2

2-hexyloxyethanol; ethylene glycol monohexyl ether; n-

hexylglycol 112-25-4 3 3 3 2 3

Ethyl(1-naphthyl)amine 118-44-5 3 3 3 3 No data

4-Diethylaminobenzaldehyde 120-21-8 3 3 3 3 No data

1,2-dihydroxybenzene; pyrocatechol 120-80-9 3 3 3 3 3

Triethylamine 121-44-8 3 2 3 1 2

Cresol 1319-77-3 3 2 3 1 2 1

Butyl(ethyl)amine 13360-63-9 3 3 3 2 No data

1-naphthylamine 134-32-7 3 3 3 3 3

2-piperazin-1-ylethylamine 140-31-8 3 2 3 3 2 2

Dipropylamine 142-84-7 3 3 3 3 3

Sodium dodecyl sulphate 151-21-3 3 2 3 1 1 2

3,3'-(Methylimino)bispropiononitrile 1555-58-4 3 3 3 3 No data

2-Methyl-3-butenenitrile 16529-56-9 3 3 3 2 No data

Cyclohexanemethanamine, .alpha.-methyl-, (.alpha.S)- 17430-98-7 3 3 3 No data

Aluminium tri-sec-butanolate 2269-22-9 3 3 3 3 3

2-(Dimethylamino)ethyl acrylate 2439-35-2 3 3 3 2 3

Diaminotoluene, technical product - mixture of 4-

methyl-m-phenylene diamine and 2-methyl-m-

phenylene 25376-45-8

3 3 3 2 3

L-.alpha.-Methylbenzylamine 2627-86-3 3 3 3 2 No data

1-Butanol, 3-amino- 2867-59-6 3 3

not

found No data

N,N,N',N'-Tetramethyl-2,2'-oxybis(ethylamine) 3033-62-3 3 3 3 2 3

Isododecane 31807-55-3 3 3 3 1 2

2-Octanamine, (2R)- 34566-05-7 3 3 3 3 No data

Crotonic acid 3724-65-0 3 3 3 2 3

N-[3-(Dimethylamino)propyl]-N,N',N'-

trimethylpropane-1,3-diamine 3855-32-1 3 3 3

not

ofund 3

D-.alpha.-Methylbenzylamine 3886-69-9 3 3 3 3 3

R-(+)-1-(1-Naphthyl)ethylamine 3886-70-2 3 3 3 No data

N,N-Diethyl-2-propynylamine 4079-68-9 3 3 3 3 3

N-Methylisopropylamine 4747-21-1 3 3 3 No data

(R)-.alpha.-Cyclohexanemethylamine 5913-13-3 3 3 3 No data

1-Butanol, 3-amino-, (3R)- 61477-40-5 3 3 No data

DL-.alpha.-methylbenzylamine 618-36-0 3 3 3 No data

Diethyl sulphate 64-67-5 3 3 3 3 3

Thioglycolic acid 68-11-1 3 3 3 3 3

Cyclohexanol, 2-amino- 6850-38-0 3 3 No data

Benzenesulfonic acid, C10-16-alkyl derivs. 68584-22-5 3 3 3 2 2

Tetrahydro-2,5-dimethoxyfuran 696-59-3 3 3 3 3 3



Cyclohexanol, 2-amino-, (1R,2R)-rel- 6982-39-4 3 3 No data

2-Pyrrolidinone, 5-ethenyl- 7529-16-0 3 3 No data

2-aminopropane; isopropylamine 75-31-0 3 3 3 1 1

Tert-Butyl hydroperoxide 75-91-2 3 3 3 1 2 2

Propylidynetrimethanol 77-99-6 3 3 3 2 2

Isoprene (stabilized); 2-methyl-1,3-butadiene 78-79-5 3 3 3 1 3

Acrylic acid 79-10-7 3 1 3 1 - 1 2

Methyl chloroformate 79-22-1 3 3 3 2 3

Isobutyric acid 79-31-2 3 3 3 3 3

.alpha.,.alpha.-dimethylbenzyl hydroperoxide; cumene

hydroperoxide 80-15-9 3 3 3 1 3 3

1,1,3,3-Tetramethylguanidine 80-70-6 3 3 3 3 3

hexamethylene diisocyanate 822-06-0 3 1 3 3 3

4-Methylimidazole 822-36-6 3 3 3 3 3

1-vinyl-2-pyrrolidone 88-12-0 3 3 3 3 3

2-tert-Butylphenol 88-18-6 3 3 3 3 3

Salicylaldehyde 90-02-8 3 3 3 3 3

N,N-Dimethylbutylamine 927-62-8 3 3 3 3 No data

2-Ethyl-4-methylimidazole 931-36-2 3 3 3 3 3

o-cresol 95-48-7 3 1 3 2 2 1

2-Chloroaniline 95-51-2 3 3 3 No data

Allyl methacrylate 96-05-9 3 3 3 3 3 2

Acetic acid, chloro-, methyl ester 96-34-4 3 3 3 2 3 2

1-Methylpyrrole 96-54-8 3 3 3 3 3

2-Diisopropylaminoethanol 96-80-0 3 3 3 3 No data

2-furaldehyde 98-01-1 3 3 3 3 2 2 2

Nicotinamide 98-92-0 3 3 3 3 3

1,1,1,3,3,3-Hexamethyldisilazane 999-97-3 3 3 3 3 3

Calcium dipropionate 4075-81-4 2

Benzene (1 - methylethyl) - oxidised polyphenyl residues 68333-89-1 2

2 -methylpyridine 109-06-8 2

Propylene diamine 78-90-0 3

Ethyl acrylate 140-88-5 1

3, 6, 9 - tri azaundecamethylene 112-57-2 2

Hydroquinone 123-31-9 2

Maleic anhydride 108-31-6 1

Methacrylic acid 79-41-4 2

Chlorocresol 59-50-7 2


1, 2, 3 - trichloropropane 96-18-4 2

Area A5:

Tx / Cat 2 Inhalation, aerosol/dust/mist

(LC50 0.05-0.25 mg/L)

CAS num-

ber MS

1

MS

2

MS

3

MS

4

MS

5 MS 6

SPIN

data Industry

1,1,2,2-tetrabromoethane 79-27-6 3 3 3 3 3

3,5,5-Trimethylhexanoyl chloride 36727-29-4 3 3 3 3 3

1,4-dichlorobut-2-ene 764-41-0 3 3 3 1 No data

Chloroacetaldehyde 107-20-0 3 3 3 3 3

Trichloronitromethane;

chloropicrin

76-06-2 3 3 3 2 3

Phosphorus trichloride 7719-12-2 3 2 3 1 1

2-methylaziridine;

propyleneimine

75-55-8 3 3 3 3 3



2-(Dimethylamino)ethyl acrylate 2439-35-2 3 3 3 2 3

Sodium dichromate anhydrate 10588-01-9 3 3 3 2 3 1

Vitamin D2 Pulver 50-14-6 3 3 3 3 3 1

Vitamin D3 Pulver 67-97-0 3 3 3 3 3 2

Dihexylamine 143-16-8 3 3 3 2 No data

Chlorothalonil 1897-45-6 3 2 3 2 3

Chloromethyl ethyl ether 3188-13-4 3 3 3 3 3

Ethyl chloroformate 541-41-3 3 3 3 2 3

Methyl chloroformate 79-22-1 3 3 3 2 3

O,O – diethylphosphorochloridothioate 01-04-2524 3 3 3 No data

O,O – dimethylphosphorochloridothioate 2524-03-0 3 3 3 3

Peracetic acid 79-21-0 3 2 3 2 2

Tetraethyl lead 78-00-2 3 3 3 2 3

Thioglycolic acid 68-11-1 3 3 3 2 3

Dimethylaminosulphonyl chloride 13360-57-1 3 3 3 3 No data

Phosphorus oxychloride 10025-87-3 3 2 3 2 3

Iodine 7553-56-2 3 2 3 1 2 2

Phosphorus pentoxide 1314-56-3 3 2 3 3 2 2

Sulphuric acid mist 7664-93-9 1 2 3 1 1 1

Area A6:

T / Cat 3 Inhalation, gas

(LC50 500 ppm - 2.0 mg/L/4 hr)

CAS num-

ber MS

1

MS

2

MS

3

MS

4

MS

5 MS 6

SPIN

data Industry

Chlorotrifluoroethylene 00079-38-9 3 3 3 3 No data

Sulphur dioxide 7446-09-5 1

Ethylene oxide 75-21-8 1

Diisopropylamine 108-18-9 2

Acetic anhydride 108-24-7 1

Methylamine 74-89-5 2

Cyclohexanone 108-94-1 1

2 - dimethylaminoethanol 108-01-0 -

Cyclohexanol 108-93-0 -

Tert-butyl acrylate 1663-39-4 1

Ethylenediamine 107-15-3 2

Pentane - 2, 4, dione 123-54-6 1

3 Aminopropyldimethylamine 109-55-7 2

3, 5, 5 - titrimethylcyclohex - 2 - enone 78-59-1 2

Cyclohexamine 108-91-8 3


Area A7:

Xn / Cat 3 Inhalation gas

(LC50 2.0 mg/L/4 hr - 2500 ppm)

CAS num-

ber MS

1

MS

2

MS

3

MS

4

MS

5 MS 6

SPIN

data Industry

Hexafluoroisobutene 00382-10-5 3 3 3 No data

Hexafluoro-1,3-Butadiene 00685-63-2 3 3 3 No data

Ammonia 7664-41-7 1

Methyl formate 107-31-3 2

4 - methylpentan - 2 - one 108-10-1 3

Methacrylic acid 79-41-4 2



Appendix D Major accident potential assessment and scoring

Area Substance Uses Importance Experience Exposure Score Comment

A2 Natriumchloriet (bedoelen ze 'so-dium chloride, CAS 7647-14-5)

Water treatment (ionite filter regeneration); Chlorine, PVC, Inorganic chemistry, chlorine pro-duction, foods, road treatment, others

Rated 1 by four respondents - many estab-lishments

4a 1 95

Sodium chlorite 7758-19-2 TAD 2: (3098) public swimming pool formation of Cl2 with reaction w acid 42 injured (4b) (culprit hypochlorite?) MARS 2: a) env release, fish kill, b) mix incompat explosion (=4a) Gsearch municipal water treatment tank explosion, subst incompat (3a) Exp judg 4a

Epichlorohydrin (106-89-8)

Eoxide resins, others; Paper industry; a chemi-cal intermediate used primarily in the manufac-ture of epoxy resins and synthetic glycerol

Rated 1 by three respondents - one indicate two establishments (plus industry and SPIN data)

4b 3 100

TAD 16: a) tank expl, incompatability b) (8472) storage tank explosion, incom-patible chemical, motorways closed (=4b), c) transport acc evac 1200 people enough data for 4b bp 116 (3)

Cadmium oxide (1306-19-0)

electroplating, painting, glass, battery, vitreous enamel, making all kinds of alloy and the raw ma-terials for making cad-mium salt

Rated 1 by one (not initially on the list)

0 1 0

TAD 0 MARS 0 expert judgement =0

Dimethyl sulphate (77-78-1)

Intermediate. Chemical synthesis

Rated 1 by one (not initially on the list) 2 3 40

TAD 4: a) reactor explosion (=2) MARS 1 (minor release) Bp 188 (=3)

Acrylamide (79-06-1)

water-soluble polymers used as additives for water treatment, en-hanced oil recovery, flocculants, papermak-ing aids, thickeners, soil conditioning agents, sewage and waste treatment, ore process-ing, and permanent press fabrics.


0 3 2

TAD "acrylamide" 0 MARS 0 bp 125 (=3) expert judgement =0

Methyl chloroace-tate (96-34-4)

Used in the manufacture of medicines and pesti-cides


0 3 2

TAD "methyl chloroacetate" 1: reactor overheats and emits fumes MARS 0 Gsearch empty Bp 130 expert judgement =0

Methyl iodide (74-88-4)

Methyl iodide is used as an intermediate in the manufacture of some pharmaceuticals and pesticides


3a 4c 90

TAD "methyl iodide" 2: lab explosion MARS 0. Gsearch - After an industrial accident, an exposed chemical plant worker de-veloped symptoms of central nervous system poisoning and died Bp 42.5 (4c) Assume 3a

Sodium nitrite (7632-00-0)

colour fixative and pre-servative in meats and fish; manufacturing di-azo dyes, nitroso com-pounds, and other or-ganic compounds; in dyeing and printing tex-tile fabrics and bleaching fibers; in photography; as a laboratory reagent and a corrosion inhibi-tor; in metal coatings for phosphatizing and det-inning; and in the manu-


3b 1 90

TAD "sodium nitrite" 7, incompatibility, produces NOx MARS 0. exp judgement 3b in theory, the reaction product (the con-cern) is comprised separately by Seveso.




facture of rubber chemi-cals.

Ammonium Di-chromate (as Cr VI) (7789-09-05)

Used as a strong oxi-diser

Rated 1 by one (not initially on the list) 2 1 20

TAD 2: a) expl in dryer, two fatalities, b) expl and smal fire exp judg =2

A2B Nickel sulfate hexahydrate (10101-97-0)

Mineral manufacturing; Manufacture of fabri-cated metal products, except machinery and equipment


0 1 0

TAD "nickel sulfate hexahydrate" 0 MARS 0 exp judgm =0

Potassium hydrox-ide (1310-58-3)

Fertilizer production, household chemical products; fine chemi-cals; Glue production, Chemical synthesis, Maintenance (mineral industry); used in paint and varnish removers, drain cleaners, degreas-ing agents and dairy pipeline cleaners.

Rated 1 by four (plus SPIN data)

0 1 0

MARS 1 irrelevant TAD 16 irrelevant exp judg =0

Some/many establishments

Sodium sulphide (1313-82-2)

Leather manufacturing; fine chemicals; Water treatment (mineral indus-try)

Rated 1 by two (plus SPIN)

3a 1 50

TAD 6: a) generation of H2S MARS 0 it is the reaction product that is the con-cern, not the Na2S

One respondent indicated few establishments

1,3-Propanediol, 2-bromo-2-nitro- (52-51-7)

Preservatives; Adhesive, Paint

Rated 1 by one (many estab-lishments, small volumes, high importance)

0 1 0 expert judgement =0

Sodium thiocy-anate (Component) (540-72-7)

Solvent for acrylic fibre manufacture. Photo-chemical bleach. Used in pesticides

Rated 1 by one

0 1 0

TAD 0 MARS 0 expert judgement =0

Aniline (62-53-3) Pigments and dyes; rub-ber manufacture, indus-trial solvent, varnishes; others

Rated 1 by two (plus industry) - many estab-lishments

4a 3 95

TAD 44: most are irrelevant. a) major leak cause env damage, b) (5539) re-lease of 2.5t from plant caused toxic cloud drifting over ship (=4b), c) exo-therm explosions, dyestuff plants MARS 0. Bp 184

didecyldimethyl-ammonium chlo-ride (7173-51-5)

Biocide Rated 1 by one 0 1 0 expert judg =0

Methyl acrylate (96-33-3)

Plastics, paints, sol-vents, others; Used as a monomer or co-monomer in making acrylic and modacrylic fibres

Rated 1 by two - many estab-lishments

0 4a 5

TAD 3: little relevance MARS 0 Gseach - exp and fire of storage tank bp 81 exp judg =0

m-cresol (108-39-4) Many industries; used in disinfectants, in resins, as a raw material for photographic develop-ers, in ore flotation, in fumigation compounds, in explosives, in phenol, as an insecticide, as a wood preservative, in degreasing compounds, in paintbrush cleaners and as an additive to lubricating oils. It is also used as an intermediate in the manufacture of

Rated 1 by two (plus industry) - many estab-lishments

0 2 0 see cresol




chemicals, dyes, plastics and antioxidants. It is used in the manufacture of antiseptics, phos-phate esters, herbicides and perfumes, as a sol-vent, as an engine and metal cleaner and in the textile industry

Hexylamine (111-26-2)

intermediate for pesti-cides, surfactants, cor-rosion inhibitors, dyes, rubber chemicals, phar-maceuticals

Rated 1 by one

0 3 2

TAD 0 MARS 0 bp 131 (=3) exp judg =0

Ethylacrylat (140-88-5)

Plastics, paints, sol-vents, others; Intermedi-ate for polymers and other chemicals.

Rated 1 by two - many estab-lishments (plus comment) 0 4a 5 assume similar to ethyl acrylate

Dimethyl disul-phate (624-92-0)

Organosulfur com-pounds are widely used in refineries, steam-crackers, aromatic ex-traction and petrochemi-cal manufacturing


0 3 2

TAD 0 MARS 1: irrelevant Bp 109 exp judg =0

A3 Formaldehyde (50-00-0)

Na Rated 1 by one (not initially on the list)

4b 4a 100

MARS a) runaway 4b, b) expl 4b, enough for 4b Bp 96°C

A4 1-chloro-2,3-epoxypropane (106-89-8)

chemical intermediate used primarly in the manufacture of epoxy resins and synthetic glycerol. It is also used in the production of elas-tomers, polyamines, water treatment chemi-cals flame retardants and a variety of glycidyl derivatives.


4b 3 100

Double entry - also row 3 TAD "epichlorohydrin" -16 - a) expl 4a, b) incompat 4b, c) rail acc 1200 evac - enough for 4b Bp 116°C

2,3-epoxypropyl methacrylate; gly-cidyl methacrylate (106-91-2)

Basic plastic (also used in maintenance product (mineral industry))

Rated 1 by one

0 3 2

TAD "methacrylate" 17 results - none relevant MARS 0, Gsearch "epoxypropyl methacrylate accident" 0 BP 189

Cyclohexanone (108-94-1)

Organic dyes, resins, caprolactam; Production of organic peroxides for reinforced plastics (also used in maintenance product (mineral indus-try)); an industrial sol-vent and as activator in oxidation reactions

Rated 1 by three (one respondent indicate two establishments)

4a 3 95

double entry TAD 4, a) confined entry, b) expl =4a MARS 4a expl+1

Phenol; carbolic acid; monohy-droxybenzene; phenyl alcohol (108-95-2)

Plastics, organic synthe-sis, others; adhesive (also used in mainte-nance product (mineral industry))

Rated 1 by three (plus SPIN) - many estab-lishments

4b 3 100

TAD "phenol" 141. MARS a) =4a, b) resin runaway =4b, enough for 4b Bp 182°C

Diethylamine (109-89-7)

Corrosion inhibitor and intermediate in the pro-duction of rubber, res-ins, dyes and pharma-ceuticals.

Rated 1 by one

3a 2 60

TAD "diethylamine" 0 MARS 0, Gsearch "diethylamine accident" a) "VanChem in Lockport, NY in June 1997. Five injured" =4a (fumes) pauvre results, expert judgement =3a Bp 56°C

Morpholine (110-91-8)

Manufacturing of ethanol based fuels

Rated 1 by one

0 3 2

TAD "morpholine" 0. MARS 0. Gsearch 0 Bp 129°C




2-butoxyethanol; ethylene glycol monobutyl ether butyl cellosolve (111-76-2)

Paints, others; Glue and paint production (also used in maintenance product (mineral indus-try)); a solvent in paints and surface coatings


0 3 2

TAD "butoxyethanol" 0 MARS a) fire =2 now try "butylglycol" TAD "butylglycol" 0 TAD "butyl glycol" 1: spill Gsearch "butylglycol accident" very pauvre, expert judgm=0 BP 171 °C

Triethylamine 121-44-8)

Catalytic solvent in chem synthesis, polyurethane foams, rubber, dyes, pesticides, herbicides

Rated 1 by one

2 2 30

TAD "triethylamine" 1: USSR derail accident, 3,000 people evac (unclear, dubious) MARS 0 Gsearch ""triethylamine accident" a) runaway =2, (could be =1) Bp 90 °C

Cresol (1319-77-3) Used to dissolve other chemicals, as disinfec-tants and deodorizers, and to make specific chemicals that kill insect pests.

Rated 1 by one (plus industry)

0 2 0

TAD "cresol" 10: a) transportation acci-dents, b) spill soaking worker Gsearch is mostly empty expert judgement =0 Bp 90°C

Sodium dodecyl sulphate (151-21-3)

Basic plastic; Anionic surfactant for household products and in gas hy-drate or methane hydrate formation reactions.

Rated 1 by two

0 1 0

TAD "dodecyl sulfate" 0 MARS 0, Gsearch empty =0 powder

Isododecane (31807-55-3 )

Solvent used in chemical synthesis, paints etc

Rated1 by one 0 1 0 expert judgement =0

2-aminopropane; isopropylamine (75-31-0)

Solvent, synthetic agent Rated 1 by one (plus SPIN)

0 4c 20

TAD "isopropylamine" 0 MARS 0 Gsearch empty expert judgment =0 Bp 34°C

Tert-Butyl hydrop-eroxide (75-91-2)

Basic plastic and rein-forced plastics industry

Rated by one

4a 4a 100

TAD 20: a) fire and explosion (=2), b) reactor explosion (=4a) MARS 1 (=1) expert judg =4a Bp 89

Isoprene (stabi-lized); 2-methyl-1,3-butadiene (78-79-5)

Isoprene is used as a chemical intermediate to manufacture primarily polymers

Rated 1 by one

3b 4c 95

TAD 5: a) massive internal vessel expl =3b, b) VCE =4a, c) expl MARS 0. unclear how stabilized subst should be rated, exp judg =3b Bp 34 (=4c)

Acrylic acid (79-10-7)

Prod.of acrylates; basic plastic (also used in maintenance product (mineral industry))

Rated 1 by three

4b 3

TAD 23: a) large storage tank over-heats, evac (=4b) (polym reac) MARS 0. exp judg =4b (but not toxic) Bp 141 (=3)

.alpha.,.alpha.-dimethylbenzyl hydroperoxide; cumene hydroper-oxide (80-15-9)

Reinforced plastics in-dustry - many estab-lishments (also used in maintenance product (mineral industry))

Rated 1 by one

4a 3 95

TAD " cumene hydroperoxide" 18: a) expl (decomp) =4a, storage tank expl =4a, c) runaways MARS 0. Bp 153 (=3)

hexamethylene diisocyanate (822-06-0)

Plastics, others Rated 1 by one - many estab-lishments

2 2 30

TAD "diisocyanate" 15: a) subst incom-pat, reactor expl =2, other results irrele-vant MARS 0. Gsearch pauvre, exp judg =2 Bp 255 (=2)

o-cresol (95-48-7) PU foams, others - many establishments

Rated 1 by one - many estab-lishments 0 2 0 similar to cresol

Maleic anhydride (108-31-6)

A highly versatile chemi-cal intermediate essen-tial to the production of a multitude of products


4b 3 100

TAD "maleic anhydride" 13 MARS 2: a) reactor runaway =4b Bp 200 =3

1, 3 - dichloropro-pene (542-75-6)

Used as a solvent in polystyrene manufacture

Rated 1 by one (not initially on 0 3 2

TAD "dichloropropene" 0 MARS 0.




as well as SBR Latex Production. Used in fun-gicides for agriculture, garden and health ser-vice use. Used in pesti-cide products and as a soil fumigant/ nemati-cide.

the list) Gsearch - transport acc with minor con-sequences exp judg =0 Bp 108 =3

A5 1,4-dichlorobut-2-ene (764-41-0)

Intermediate in prepara-tion of nylon

Rated 1 by one

0 2 0

TAD "dichloro-2-butene" 0, MARS 0. try 1,4-Dichloro-2-butene: also empty incl Gsearch Bp only @ vac

Phosphorus tri-chloride (7719-12-2)

PCl3 is important indi-rectly as a precursor to PCl5, POCl3 and PSCl3


4b 4b 100

TAD 6, a) 4b, b) road transport =4b, c) runaway =4a MARS 1: exothermic reaction w water, fire and HCl mist offsite Bp 73°C

Iodine (7553-56-2) Chemical synthesis, Pharmaceutic industry (also used as laboratory chemical (mineral indus-try))

Rated 1 by one

1 3 5

TAD 5, a) 1, b) 1, c) 2 (release) MARS 0, Gsearch "iodine accident -nuclear -131 -radioactive" 0 Bp 183°C

Sulphuric acid mist (7664-93-9)

Fertilizer production, for leather manufacturing, water treatment; Chemi-cal synthesis, Glass polishing, Manufactur-ing, Paint production


4b 3 100

MARS a) 1, b) cloud 4b, c) 1, d) 1, e) 4b, enough for 4b classification. Unclear if subst already covered by SO3 or H2SO4

A6 Sulphur dioxide (7446-09-5)

Sulphur dioxide is some-times used as a pre-servative in alcoholic drinks, or dried fruit such as apricots and raisins, due to its antim-icrobial properties. The preservative is used to maintain the appearance of the fruit rather than prevent rotting.

Rated 1 by one (not ini-tially on the list)

5 5 100 TAD 11382, 8934, 11330 ad libitum

Ethylene oxide (75-21-8)

Used as an intermediate in the production of eth-ylene glycol and other chemicals, and as a ster-ilant for foodstuffs and medical supplies.


4a 5 100

TAD 392 (explosion) several in MARS, fires and explosions, also one w serious skin burns

Acetic anhydride (108-24-7)

Used for acetylation of alcohols and amines.


4a 3 95

TAD 15, a) 5t release =2, b) hydrolysis - vapour, contractor =4a, c) several trans-portation accidents leading to evac =4a/4b MARS 0, Gsearch returns several, skin, inhal, explosion www.ncbi.nlm.nih.gov/pubmed/7999282

Cyclohexanone (108-94-1)

Industrial solvent and as activator in oxidation reactions


4a 3 95

double entry TAD 4, a) confined entry, b) expl =4a MARS 4a expl+1

Tert-butyl acrylate (1663-39-4)

Used in rigid and semi-rigid acrylic plastics.


1 3 5

TAD 5, spills, fire, no toxic MARS 0, Gsearch empty, Bp only avail at vac, but flash at 11°C

Pentane - 2, 4, dione (123-54-6)

A colorless to slightly yellow liquid with a pleasant odor. It is used in the manufacture of colors, paints, varnishes, resins, inks, dyes, phar-maceuticals, and other chemicals, as a pesti-cide, and as an additive


0 3 2

TAD "pentanedione" 0, MARS 0 Bp 140, try 2,4-pentanedione, TAD 0, MARS 0, Gsearch nil




to gasoline

A7 Ammonia (7664-41-7)

Most important use is in the production of nitric acid.


5 5 100 obvious

impact assessment study into possible options for … · into possible options for adapting annex 1...

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