CHEMICAL SAFETY REPORT - Europa€¦ · Non-confidential version CHEMICAL SAFETY REPORT 19 . The feed (lube oil basestocks) is diluted (first dilution) to the extent required for

Non-confidential version CHEMICAL SAFETY REPORT i

CHEMICAL SAFETY REPORT

Substance Name: 1,2-dichloroethane

EC Number: 203-458-1

CAS Number: 107-06-2

Applicant(s):

Grupa LOTOS S.A.

Use applied for:

Use as an extraction solvent in the de-waxing of petroleum vacuum distillates and de-

asphalted oil and de-oiling of slack wax for the production of base oils and paraffinic waxes

EC number:

203-458-1

1,2-dichloroethane CAS number:

107-06-2

Non-confidential version CHEMICAL SAFETY REPORT 17

9. EXPOSURE ASSESSMENT.

9.0. Introduction.

Grupa LOTOS has one European refinery site (Gdansk, Poland) using EDC as solvent in the de-

waxing and de-oiling process.

The aim of the Lube Oil Complex which one of the part is 1300 De-waxing Unit is to obtain lube oil

basestocks (“base oils”) from crude oil vacuum distillate units by separating them according to

viscosity and boiling point specifications. One undesirable characteristic of these basestocks is the

presence of paraffin wax (high molecular weight hydrocarbons) which is responsible for poor flow

properties at ambient temperatures. The paraffin wax is removed in the de-waxing process in order to

obtain a finished oil with good pour point properties.

Grupa LOTOS uses a mixture of EDC and DCM to dilute the waxy raffinate in conjunction with

refrigeration to crystallize out the wax which is then filtered, i.e. in three main steps: crystallization,

filtration and solvent recovery. Through this de-waxing process, Grupa LOTOS generates three

grades of base oils and three grades of slack waxes.

De-waxing may be followed by a de-oiling stage, also taking place at the 1300 Unit. In the case of

de-oiling, slack wax (rather than vacuum distillate) is used as feedstock in the production line and

EDC-DCM is still used as a solvent. For the de-oiling of the slack wax, the process temperature is

raised and other operating parameters of the line are adjusted to allow a similar process of dilution,

crystallization, filtration and solvent recovery. This process generates hard paraffin waxes (in two

grades) and foot oils.

9.0.1. Process description.

In the de-waxing and de-oiling process EDC exists as the mixture together with the second chemical

compound, Dichloromethane (DCM). Only such mixture is considered as the solvent. The ratio of the

components is 30-50%EDC & 50-70%DCM. The mixture of EDC-DCM dissolves the oil in the feed

and splits the feed into the oil and wax. The solvent dewaxing process involves the removal of

naturally occurring waxes from feed by means of suitable solvent. Dewaxing is carried out in

presence of a solvent mixture consisting of EDC-DCM because the former is a wax anti-solvent

favouring the crystallization of wax necessary to obtain the desired pour point and the latter an oil

solvent which ensures complete solubility of the oil at the filtering temperature without excessive

dissolution of the wax. Summing up, the ECD is an anti-solvent of a wax while DCM completely

dissolves an oil at the filtration temperature without impact on the wax solubility. These selective

properties of the solvent components are the main characteristics of the solvent used. EDC exists

inside the unit in the circulation loop.

For EDC the de-waxing and de-oiling process can be divided into 5 main steps (see figure 1):

Feed and EDC (solvent) mixing; first dilution.

Cooling of the feed/solvent mixture.

Filtration of the dewaxed oil; second dilution.

Distillation of the solvent from the products and process water.

Drying of the solvent. The dried solvent is re-used (recirculated) in the process.

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Figure 1 – Process overview.

First dilution, pure solvent

Second dilution, pure solvent

Feed

Oil (deparafinate)+ solvent

Wax + solvent

Solvent-water

Solvent-water

Solvent-water

Solvent-water

Solvent-waterSolvent-waterSolvent-water

Solvent-water

Solvent-water

Solvent-water

Solvent-water

Solvent-w

ater

Solvent-w

ater

Solvent-w

ater

Solvent-w

ater

Pure S

olvent

Pure S

olvent

Pure S

olvent

Pure Solvent

Battery of the scraper chillers and coolers

Battery of the rotary drum

filters S1A-H

deparafinate+solvent

vessel V1 wa

x+

so

lve

nt

ve

ss

el V

2

distillation

columns for

wax C1 to C4

distillation

columns for

dewaxed oil

C5 to C9

Stripper water

treatment column C10

water/solvent

separation vessel

V7A-B

pure solvent

vessel V3A/BFeed and EDC

(solvent) mixing;

first dilution

Cooling down the

feed/Solvent

mixture

Filtration of the

dewaxed oil;

second dilution

Distillation of the

solvent from the

products

Distillation of the

solvent from the

process water

Drying of

the solvent

I

II

III IV

V

IV

C1

C2

C3

C4

C5

C6

C7

C8

C9

C10

V7B

V7A

V3A

V3B

Stripping st

eam

Wate

r

Wax

Dewaxed

Oil

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The feed (lube oil basestocks) is diluted (first dilution) to the extent required for cooling and filtration

by admitting fresh, pure solvent from vessel V3B. The mixture of feed/solvent is cooled in the battery

of the scraper chillers and coolers (up to -18°C) (see photo 1 and 2).

Photo 1 – Battery of the scraper chillers and coolers.

The cooled oil/solvent mixture is admitted to the continuously operating, gas-tight cellular drum

filters S1A-H (see photo 2).

Photo 2 – Battery of the rotary drum filters.

Each filter is designed to continuously filter the wax from the chilled solution of oil and solvent. The

filters drums are slowly rotated. The flow through the filtering medium is induced by vacuum applied

beneath the filtering medium through the filtrate piping. Wax is accumulate on the filter drum during

the pick-up or filtering portion of the cycle, and after emerging from the liquid is washed continuously

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by the solvent mixture. Wash solvent (second dilution) is introduced in such a manner as to provide

a continuous film of solvent over the wax cake in the washing zone. The wash solvent is drawn

through the wax cake to displace the oil solvent solution originally contained in the cake. Sprays and

drip pipes are installed in the filter for the application of this wash. The filtrate is sucked through the

filter cloth to the filtrate collector, vessel V1 (see photo 3). The crystallized paraffin is retained on the

filter cloth of the drum. The wax is releases from the drum at a point where it falls by gravity into the

wax discharging equipment. A smooth deflector blade is installed to direct the flow of wax to a spiral

scroll (screw conveyor) which moves the wax to the outlet nozzle. Next, the wax is transported via

slack wax screw conveyors to the slack wax collector, vessel V2.

Photo 3 – Vessel V1A/B, mixture of dewaxed oil and solvent.

The solvent-containing products, filtrate (deparafinate + solvent) and slack wax (wax + solvent)

obtained by filtration are freed from solvent in evaporating system with strippers. Three flash columns

and two strippers for filtrate and two flash columns and two strippers for slack wax solvent recovery

have been provided (see photo 4).

The vapours from filtrate flasher C5 and wax flasher C1 and vapours from C7 are condensed and

collected in the vessel V7B. The vapours from filtrate flasher C8 and wax flasher C3 and vapours

from C10 are condensed and collected in the vessel V7A. V7A works as separator of water from EDC

and V7B works as separator of water from DCM.

Both section V7A and V7B work full of liquid and the water is separated at the top. Water from V7

comes out of the top and is fed to the C10 water stripper where the remainder in the water solvent

is stripped and the free of solvent water is sent to the Waste Water Treatment unit.

The solvent from the V7B, containing only the solved water is pumped as the reflux to filtrate flasher

C5 where the traces of water are removed counter-currently to the rising solvent vapours by means

of seven valve trays. The dried solvent flows by gravity to the wash, pure solvent collector, vessel

V3A.

The solvent from the V7A, containing only the solved water is pumped as the reflux to filtrate flasher

C1 where the traces of water are removed counter-currently to the rising solvent vapours by means

of seven valve trays. The dried solvent flows by gravity to the wash, pure solvent collector, vessel

V3B.

The vapours from the filtrate flasher C6 are completely condensed and collected in the wash, pure

solvent collector V3A.

The vapours from the filtrate flasher C2 are completely condensed and collected in the wash, pure

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solvent collector V3B.

Pure solvent from the vessel V3A/B is used to first and second dilution in the de-waxing and de-oiling

process.

Photo 4 – Distillation part of the unit.

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9.0.2. Rigorous containment of the substance by technical means.

Production unit.

All equipment and processes from production units involving EDC are under closed systems. All of

the columns, vessels are equipped with the control systems i.e. level, pressure, temperature control

devices. The seals of the rotary equipment are mainly single but the process of replacing them with

the double-axial face seal with barrier fluid is under execution. The drained streams which contain

EDC are collected in the close drain vessel and are reprocessed in the unit. In case of emergency, the

equipment is connected to the buffer vessels T1, T2, T3, T5 located on the unit. The buffer vessels T1,

T2, T3, T5 are under filtration gas blanket.

Storage.

EDC are stored at the plant in four buffer vessels T1, T2, T3, T5 located on the unit (see photo 5).

The vessels are destined for storage of pure EDC after transportation, for storage of sent back mixture

of EDC/Dichloromethane during reduction of unit capacity or emergency situation and for

contaminated EDC with oil for further processing inside the unit. Around the vessels the protection

wall against the overflow is provided, in case of leakage.

All liquid transfer operations follow detailed written procedures to minimize the risks of accidental

leakage.

Photo 5 – buffer vessels of solvent T1, T2, T3, T5.

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9.0.3. Procedural and control technologies to minimise emission.

For the purpose of absorbing potential solvent vapours from the filter seals by oil a so-called ‘ECO

system’ is installed in the plant. It consists of an absorption tower, a vent gas blower and an oil cooler.

The absorber is a small column filled with a random packing.

In dewaxing and deoiling process the gaseous EDC is absorbed in the oil at the ECO System and is

recycled to the process, the drained liquid EDC, also dissolved in the oil, is collected in the closed

slop system and is recycled to the process.

All equipment is located outside building except rotary drum filters and gas compressors.

All equipment of Solvent De-waxing unit is connected to a general vent-gas balance vessel to ensure

regular pressure in the unit and to avoid releases (closed system) (see photo 6).

Photo 6 – Balance vessel of the internal gas (the close system).

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9.0.4. Cleaning and maintenance. General maintenance: The general maintenance of equipment is done over 3 weeks every 4 years. Before any

equipment is dismantled, the equipment is purged with solvent (DCM/EDC) until all wax is washed off. The

solvent is returned to the plant‘s feed (circulated in an enclosed system). Then the equipment is purged with

base oil in order to bind and flush out solvent completely. The base oil used for purging is returned to the plant‘s

feed (circulated in enclosed system) (see e.g. figure 2 – specific procedure for filters cleaning). The description

of the maintenance work to do as well as the specific risk management measure to follow are described in a

permit procedure. Personal Protective Equipment (PPE) is mandatory (inhalation full mask A2B2E2K2HgP3

and Chemical resistant gloves KCl 890 / Fluorocaoutchouc – see details page 20).

Non-routine maintenance (= maintenance only in case of dysfunction of equipment (e.g. pump), on average

once a month): In case of equipment dysfunction or equipment change, an operator from the plant unit is in

charge to connect secondary equipment (e.g. pump) when relevant. These actions are on/off valve actions. The

unit operators are not authorized to dismantle equipment. This task will be done by maintenance operators and

as for general maintenance, the equipment is flushed and purged. The description of the maintenance work to be

carried out, as well as the specific risk management measures to follow are described in a permit procedure.

Personal Protective Equipment is mandatory (inhalation full mask A2B2E2K2HgP3 and Chemical resistant

gloves KCl 890 / Fluorocaoutchouc – see details page 20). If no failure equipment detected, no cleaning or

maintenance is done on equipment (excepted general maintenance).

General and daily maintenance are done by Grupa LOTOS workshop operators (not same operators as in

production unit).

Figure 2 – shut down and cleaning of filters procedure.

Rotary drum filter preparation for repair procedure (with opening of the dome).

Stop the feed to the drum filter.

Wash the drum filter for 10 minutes using the solvent, than drain the filter and repeat the

action.

Blow off the solvent pipes to the drum filter using the nitrogen or air.

Blind the solvent pipes and mark the blinded location.

Fill the drum filter with the pure dewaxed oil in order to wash out the cloth filter to the main

filtrate line. Drain the rest of dewaxed oil with the small quantity of solvent to 1300V11.

Repeat the action. After that the filter is considered without the solvent.

Open the special Eco-system and start ventilation of rotary drum filter for 24 hours.

Open the dome of the filter and keep it open 12 hours for natural ventilation.

Check the oxygen and solvent vapour level.

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9.0.5. Organisational management measures.

The industrial site is under management system:

Health and safety: PN-N-18001.

Environmental Protection : PN-EN ISO 14001.

Quality assurance: PN-EN ISO 9001.

Procedures.

According to polish law and regulation (risk assessment on work positions), procedures are in place

to perform works under written permits including safety instructions. The good unsaved internal

practice is also applied in Lube Oil Complex. Those procedures are mainly analysed on employee

workplace safety and include:

trained, familiar with and aware of existing hazards and threats,

applying personal protection equipment,

safety exams before starting individual operations on the facilities,

responsibility for carrying out work,

safety meetings (before unusual activities if the contact with chemicals could be foreseen),

supervising works performed by contractors and their presence in the refinery,

involvement in improving safety culture (i.e. meetings once per quarter),

unit annual safety performance.

The main mandatory procedures in the 1300 De-waxing Unit are:

Permission for work on production facilities in explosive zone – GKL.48.01.00.00.

Safety Analysis – GKL.48.01.03.00.

Registry of people staying on production facilities – GKL.48.01.00.00.

Internal procedures for preparing equipment to regular repair and emergency procedure (see appendix 6 for information included in procedures).

Trained and authorised personnel

General training on risks for chemical are given each years for all operators involved in chemical

handling. Specific trainings on chemical risk handling are given regularly to all plant operators

handling EDC. All tasks involving EDC handling are done by competent and authorized operators.

(see appendix 8 for details on training process).

Figure 3 – production department trainings.

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9.0.6. Action plan to reduce EDC emissions.

Programme for improvements to the use of and exposure to EDC.

Background.

Grupa LOTOS has developed and is already implementing a long-term R&D plan which aims

to modernise the de-waxing/de-oiling unit and reduce EDC consumption and, consequently, worker

exposure to this SVHC substance. Part of this plan will be the intensification of exposure monitoring

which will in turn support the efforts of modernisation and exposure control improvement.

This programme is involving a diverse group of people within Grupa LOTOS, including process

engineers, maintenance engineers, lube oil block managers and investment project managers, along

with external experts. At present, 15 persons are involved. The programme also involves external

laboratories for emission monitoring, environmental and human health impact assessment (EIA

and HIA), and engineering companies analyse identification and selection of new equipment to

further reduce solvent losses.

Actions for the modernization of the plant and reduction of EDC consumption.

Grupa LOTOS has replaced dated or inefficient de-waxing and de-oiling equipment in the unit,

including: replacing parts of the rotary drum filters (shells, windows and seals); modernisation of

compressors; and, revamping of the turbo-compressor system. More actions are planned up before

the Sunset Date in 2017, as shown in table 1.

Table 1 - Planned modernisation actions of the de-waxing and de-oiling unit.

Equipment Scope of modernisation Planned Start – End

Rotary drum filters E,F,G

Replacing of the filter’s shell and windows and selection of new seals for windows. Execution of new type of filter lighting with new seal as the continuous improvement program.

New rotary drum filters

Replacing of existing rotary drum filters with new ones.

Pumps Replacing of pump seals with new double seals for those pumps relevant to EDC

Scraper chiller Replacing of scraper chiller seals with new double seals

Control valves Replacing of valves’ seals with new bellows seals

Pipelines Programme of pipelines measurement and selection of pipes in bad condition for replacement

Pipelines Replacement of identified pipes

A technical study is planned that will further assess some of these projects and more specifically:

Seals modifications in pumps, scraper coolers and scraper chillers.

Replacement of rotary filters.

It is expected that the entire process of modernisation will last an estimated 59 months; this includes

4 months for internal deliberations and decision-making and a further 55 months for delivering the

required production unit modifications. A preliminary valuation of the cost of the modernisation

programme is estimated at €10-100 million ( ).

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Other planned actions aimed at the reduction of EDC losses and exposure.

Engineering actions are supported by continuous organisational measures, such as reinforcing the

knowledge of the employees who directly manage EDC on the hazards and risks associated with the

substance and the information in the Safety Data Sheet (SDS). This will include the provision of

information on the classification of the substance as a SVHC and the REACH authorisation process

and requirements.

Furthermore, specific measures are planned for the improvement of awareness on exposure, the

collection of monitoring data that could be shared with the relevant authorities and the further

improvement of the controls on EDC exposure, where a need is identified.

Table 2 – Improvement plan on training.

Training At present Improvement plan

Periodic training 1 x year No changes

Discussion on research reports of

harmful factors - refresher training

on the risks associated with the use of

EDC.

2 x year No changes however note: to raise

the level of awareness about the

dangers during the EDC handling

if it is needed

Table 3 – Improvement plan on PPE.

PPE Process At present Improvement plan

Wearwork EDC unloading Antistatic + TYVEX TYCHEM

Non-routine

maintenance (small

repairs).

Antistatic + TYVEX TYCHEM

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Table 4 – Improvement plan on monitoring.

Place, stream Frequency Comment Frequency Comment

Process water at the inlet to sewer systemonce 2015 - 1 x week -

Oily rainwater on the border of the property

(from manhole/sump)

once 2015 - 1 x week -

Process water at the inlet to WWTPonce 2015 - 1 x week in the same days as in case of samples from

Lube Oil Compex with a certain time delay

Oily rainwater at the inlet to WWTPonce 2015 - 1 x week in the same days as in case of samples from

Lube Oil Complex with a certain time delay

Stream of treated sewage discharged

into the receiver (river M.Wisła)(process water and from time to time oily rainwater with sanitary

sewage when we have excess service water)

1 x month 1 x week

Receiver (river M.Wisła) below and above the

point of waste water discharge

1 x quarter 1 x quarter (no

changes)

in the same days as in case of samples from

WWTP with a certain time delay (it does not

concern receiver - it is separate measurement)

Improvement Plan

Marshal Office requirement

Ma

rtw

a W

isła

At present

Lu

be

Oil

Co

mp

lex

WW

TP

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Unloading EDC

during each

unloading (c.a. 1 x 2

years)

internal mesurement no changes

1 x year so far in 2014 and 2015 no changes at least in 2016 and 2017y

2 x year internal mesurement 2 x year (no

changes) and

also - see

comment

also after each:

- EDC unloading

- change/imrovement activity which can

result in emission reducing

- important step as filter/tank opening

before maintenance/repairing

2-3 x month according to the Annual Detail

Schedule, internal measurement

no changes -

once: 2013

once: 2014 - 2016

measurement of emission

factors according to PN-EN

15446:2008 "Niekontrolowana i

rozproszona emisja w sektorze

przemysłowym - Pomiar emisji

par wydobywających się z

nieszczelnych instalacji i

przewodów" (english version:

EN 15446:2008) - factors of EDC

emission determined in regard

to seals and flanges and than

estimated to 1300 Unit

1 x week firstly monitoring of emission points,

than sealing and then systematic

monitoring

once: 2016 imission from 1300 Unit:

detail measurement of fugitive emission

(volatile organic compounds) from 1300

Unit (specially EDC)

Around the emission point (1300 plant) and

fence of refinery from leewardbased on concentration measured around emission

point (theoretical emission calculated in the point of

emission = the middle of 1300 plant)

once: 2008

once: 2009

- 1 x 2 years immission around 1300 unit in refinery

area: 2016 and after modernisation

(after those 2 sessions additional internal

decision is needed)

Around the refinerypassive measurement of EDC concentration (gas)

and the contect of EDC in falling dust

once: 2015 - every year at least untill the modernization (than

additional internal decision is needed)

Workplace

Seals

AIR

fugi

tive

emis

sion

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9.0.7. Teams and employees involved in use of EDC.

The industrial site is producing in continuous process, 24/24, all year (general maintenance every 4

year, 3 weeks duration). As described above the processes using EDC are closed systems without

direct handling of EDC by operators except during sampling for quality control, raw material

unloading from rail tank, non-routine maintenance, general maintenance and laboratory quality

control. Then the exposure scenario will consist of 6 worker contributing scenarios:

WCS1 – Production process (de-waxing and de-oiling), including storage, transfers,

recycling, waste transfers (not covering sampling QC) (PROC 2). This WCS covers the

complete operators shift working in the plant production unit where EDC is used as described

above. The tasks done by operators are facility supervision, control from the room panel

control, visual control routines on unit.

There are 15 employees involved in Solvent dewaxing unit (i.e. three operating positions per

shift. Not the same operators are still working for the 1300 Unit. It means that an annual

exposure of EDC for every particular person can be less because of operators rotation

between all units of Lube Oil Complex. The value 15 operators is related to a required

operating positions).

Those employees are in 5 teams (3 operators by team). Per day (24/24): Team1 = shift 1: 6:00

to 14:00; Team2 = shift2: 14:00 to 22:00; Team3 = shift3: 22:00 to 6:00. Frequency of CS1 =

all year.

WCS2 – EDC sampling for quality control (PROC8b). This WCS covers the daily sampling in the unit

for QC.

This WCS2 is done by the same employees as in WCS1.

WCS3 – Reception of EDC from a rail tank (PROC 8b). This WCS covers the specific operation of the

rail tank EDC unloading. This operation is done every 2 years by Grupa LOTOS unloading team

operators, who are not involved in Lube Oil Complex. During an unloading road tank operation, 2

operators from unloading team are doing the tasks (sampling from manhole, connecting flexibles to rail

tank, disconnecting flexible after unload – see detailed description in chapter 9.1.4). The duration is

around 3 hours.

There are 2 employees in unloading operators team (not the same employees as in WCS1, WCS2,

WCS4, WCS5 and WCS6).

WCS4 – Non-routine maintenance and cleaning (PROC 8b). This WCS covers the specific

operation of small repairs in case of equipment dysfunction (e.g. pump) (see description in

chapter 9.1.5). This task is done only by maintenance operators (not the same employees as in

WCS1, WCS2, WCS3 and WCS6). There are 6 employees in the maintenance operator team

(same operators in WCS5).

WCS5 – General maintenance and cleaning (PROC 8b). This WCS covers the specific

operation of maintenance and cleaning of general equipment 3 weeks every 4 years (e.g.

reactors, vessels) (see description in chapter 9.1.5). This task is done only by maintenance

operators (not the same employees as in WCS1, WCS2, WCS3 and WCS6). There are 6

employees in the maintenance operator team (same operators in WCS4).

WCS6 – Laboratory quality control (PROC15). This WCS covers QC analysis in laboratory.

There are 38 employees in the laboratory. Only 1 employee involved during a WCS6

operation. The employees from WCS are not the same than employees from WCS1, WCS2,

WCS3, WCS4 and WCS5.

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9.0.8. Overview of uses and Exposure Scenarios.

Identifiers Market

Sector

Titles of exposure scenarios and the related contributing scenarios

ES1 – IW1 - Exposure scenario 1: Use as an extraction solvent in the de-waxing of

petroleum vacuum distillates and de-asphalted oil and de-oiling of slack

wax for the production of base oils and paraffinic waxes.

- Industrial use of processing aids in processes and products, not

becoming part of articles (ERC 4)

- WCS1: Production process including storage, transfers, recycling,

waste transfers (PROC 2).

- WCS2: EDC sampling for QC (PROC 8b).

- WCS3: Receive of EDC from rail tank (PROC 8b).

- WCS4: Non routine maintenance and cleaning (PROC 8b).

- WCS5: General maintenance and cleaning (PROC8b).

- WCS6: Laboratory QC (PROC 15).

Manufacture: M-#, Formulation: F-#, Industrial end use at site: IW-#, Professional end use: PW-#,

Consumer end use: C-#, Service life (by workers in industrial site): SL-IW-#, Service life (by

professional workers): SL-PW-#, Service life (by consumers): SL-C-#.)

9.0.9. Introduction to the assessment.

9.0.9.1. Environment.

Not applicable. Environment assessment is not subject to this CSR.

9.0.9.2. Workers.

Scope and type of assessment:

The scope of exposure assessment and type of risk characterisation required for workers are described

in the following table based on the hazard conclusions presented in the document RAC n° 33/2015/09

rev 1 final.

In June 2015 the RAC has published a reference dose response relationship for carcinogenicity of 1,2-

dichloroethane. This dose response relationship has also been used to calculate the excess risk on

cancer due to occupational exposure to 1,2-dichloroethane.

Table 5 – Excess risk calculation – workers.

Route Type of effect Type of risk

characterisation

Hazard conclusion (see RAC n° 33/2015/09 rev

1 final)

Inhalation

Systemic Long Term Semi-quantitative Excess risk = 6.0 x 10- 4 (mg/m3)-1 x concentration

(mg/m3)

Systemic Acute Not needed -

Local Long Term Not needed -

Local Acute Not needed -

Dermal Systemic Long Term Semi-quantitative Based on 50% absorption:

Excess risk = 2.1 x 10- 3 (mg/kg bw/day)-1 x dose

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characterisation

Hazard conclusion (see RAC n° 33/2015/09 rev

1 final)

(mg/kg bw/day)




Eye Local Not needed -

Comments on assessment approach related to toxicological hazard:

1,2-dichloroethane has been included into Annex XIV of the REACH regulation (list of substances

subject to authorisation) due to its intrinsic properties (carcinogenic substance; classification as carc

1B). According to Regulation (EC) No 1907/2006, Article 62 (4)(d), the CSR supporting an

application for authorisation needs to cover only those risks arising from the intrinsic properties

specified in Annex XIV. Therefore only the human health risks related to the classification of EDC as

a carcinogenic substance are addressed in this CSR.

Inhalation exposure assessment.

Worker Contributing scenario 1 (WCS1, general production process), Worker Contributing scenario 2

(WCS2, EDC sampling for QC) and Worker Contributing scenario 6 (WCS6, laboratory QC).

For those WCS, the inhalation exposure assessment for workers has been done with measured data

approach. A specific measurement campaign has been done in 2014 and 2015 based on:

CSN EN 689, BOHS NvvA sampling strategy guidance 2011 and ECHA guidance R14, 2012

for sampling strategy.

ISO 16200 (NIOSH 1003) “Workplace air quality – Sampling and analysis of volatile organic

compounds by thermic desorption/gas chromatography” for sampling and analytical requirements

(see appendix).

The sampling strategy has been based on specific on-site plant visit by Certified Industrial

Hygienist (IOHA certification). Similar Exposure Group (SEM) exposed to EDC have been

identified in each plant and linked with the Contributing Scenarios. At least a minimum of six

samples per SEM has been required as expected in the European reference CSN EN 689. The

sample collection technique has been personal air sampling – the sampling device is directly

attached to the employee within the worker’s breathing zone. It has been required from certified

laboratory to give a clear description of all technical conditions and tasks during the sampling

duration.

The measures and analysis has been done by certified laboratory in compliance with NIOSH 1003

requirements (SOCOTEC).

Worker Contributing scenario 3 (WCS3, rail tank unloading).

There are no existing measured data for this WCS, therefore a tier 2 model ART has been used as

main approach for inhalation exposure assessment. As the frequency of this activity is very low

(one every 2 years), with closed system equipment (see description in chapter 9.1.4), trained

operators and management system in place, regular measurement for this activity is considered by

Grupa LOTOS as not relevant. Also due to low frequency, it was not possible to schedule

measures campaign in 2014 for this study.

Worker Contributing scenario 4 (WCS4, non-routine maintenance) and 5 (WCS5, general annual

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maintenance).

There are no existing measured data for those WCSs, then a tier 2 model ART has been used as

main approach for inhalation exposure assessment. Scheduled maintenance is infrequent (one

every 4 years) and is only performed after equipment and pipe in-depth flushed and purged which

considerably reduces the residual quantity of solvent present in such equipment. Moreover only

trained workers are authorised to perform maintenance activities and management system covering

this activity is set up and regular internal/external audit is performed. Therefore regular

measurement for this activity is considered by Grupa LOTOS as not relevant.

The dose response relationship for EDC, as recommended by RAC, assumes a worker life time

exposure of 8 hours per day, 5 days per week during a working life of 40 years. When calculating the

excess risk due to inhalation exposure for the contributing scenarios (as Time Weighted Average

exposure over 8 hours), correction factors has been used to recalculate the exposure on a basis of 8

hours (e.g. if a measurement has been taken on 2 hours to cover a contributing scenario with a result

concentration of C1 (mg/m3), the exposure based on 8 hours will be: Exp1 (mg/m3) = C1*2/8). Such

factors considering less-than-shift duration of activities will be used in WCS3, WCS4, WCS5 and

WCS6 based on the fact that after exposure duration, the operators will no longer be involved in EDC

operations or process within the WCS assessed. For WCS4 (non-routine maintenance) and WCS5

(general maintenance), as the operators are the same (maintenance operators), the combined exposure

will be done in chapter 10. It is also the case for WCS1 and WCS2 (same operators from general

production).

The frequency of an activity is also taken into account for excess risk calculation. E.g for an activity

with a frequency of once each 6 months, the exposure result will be multiplied by a factor of

1/(5*4*6) (5 (five days/ week) multiplied by 4 (4 weeks/ month) multiplied by 6 (1 activity each 6

month)). As explained in the introduction of chapter 9.0.6 “Teams and employees involved in use of

EDC”, except for WCS1 and 2, and for WCS4 and 5, employees from a WCS are not working in

other WCSs.

When respiratory equipment is used during the task, an efficiency of 95% will be used to calculate the

real exposure. The 95% efficiency can be justified by the use of full mask with filters

A2B2E2K2HgP3 conforming with EN141 and EN 14387 (see appendix 7 for technical specifications

of PPE). Specific PPE is proposed and validated by EHS service. The PPE is available in the store-

room. The material is inspected once a year. The PPE availability is controlled by chief operator.

Audits are done to ensure good behaviour / PPE. The inhalation protective equipment (full mask) is

single use. After each use, the mask equipment is cleaned and tested by fire department. The

A2B2E2K2HgP3 filter is change after each use (the efficiency values are based on British Standards

Institution, London, 1997, American National Standards Institute, New York, 1992 and ART TNO

report 2009).

Calculation of exposure taking into account PPE:

PPE is worn during throughout the task : C real = C 33 * Effic.(0.05) PPE is worn partially during the task : C real = (C PPE * T PPE * Effic + C noPPE * T noPPE) / (TPPE

+ TnoPPE) C PPE and TPPE mean concentration and duration respectively when PPE used. C noPPE and TnoPPE mean concentration and duration respectively when no PPE used.

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Table 6 – overview of dermal and inhalation PPE used per WCS.

WCS Chemical Gloves

Mask and filters Workwear

Material

Minimum

layer

thickness

Break

through

time

Type of

Mask

Type of

filters

Sampling

EDC for QC

Chemical

resistant gloves

KCl/ nitrile

1.2 mm 30-60-

protection

against

splashes

none none Antistatic

Rail tank

unloading

Chemical

resistant gloves

KCl 890 /

Fluorocaoutchouc

< 1.0 mm 30 min. full face

mask with

absorber

A2B2E2K2

HgP3 (typ

EN 141 and

EN 14387)

Antistatic +

TYVEX *

Non-routine

maintenance

Chemical

resistant gloves

KCl 890 /

Fluorocaoutchouc


mask with

absorber

A2B2E2K2

HgP3 (typ

EN 141 and

EN 14387)

Antistatic +

TYVEX *

General

maintenance

Chemical

resistant gloves

KCl 890 /

Fluorocaoutchouc


mask with

absorber

A2B2E2K2

HgP3 (typ

EN 141 and

EN 14387)

Antistatic +

TYVEX or

TYCHEM **

Laboratory

QC of EDC

Chemical

resistant gloves

KCl/ nitrile

1.2 mm 30-60-

protection

against

splashes

none none Antistatic

* improvement plant: TYCHEM work wear instead of antistatic + TYVEX

** depending on operation and equipment.

Dermal exposure assessment.

The dermal exposure assessment has been done using Riskofderm V2.0 tier2 model with a 90th

percentile result.

As for liquids, results from Riskorfderm are given in µl, EDC density factor (1.244 g/cm3 at 20°C)

will be used to get the exposure results in mg. In the case of maintenance activity where EDC is

diluted with flushed oil the density factor of 1.244 g/cm3 will be kept as worst case value (instead of

value below 1 for oil). Body weight value of 70 kg will be used to get the final result in mg/kg/d.

The real dermal exposure duration is used for duration in Riskofderm.

When dermal equipment (gloves) is used during the task, an efficiency of 95% will be used to

calculate the actual exposure. The 95% efficiency can be justified by the use of protective gloves

satisfying the specifications of EU Directive 89/686/EEC and the standard EN 374 derived from it

(see table 6 and appendix 7 for technical specifications of PPE). Also specific PPE is proposed and

validated by EHS service. The PPE are available in the store-room. The PPE availability is controlled

by chief operator. Audits are done to ensure good behaviour / PPE. Specific trainings on PPE are

given regularly to all plant operators handling EDC.

General information on risk management related to irritation classification. A qualitative assessment was carried out with respect to eyes, skin and respiratory irritation

classification (moderate hazard, H319, H335, H315) based on OC/RMMs from ECHA, part E, Table

E.3.1. When those OC/RMM are applied, the qualitative assessment concludes to safe use:

- Containment as appropriate;

- Minimise number of staff exposed;

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- Segregation of the emitting process;

- Effective contaminant extraction;

- Good standard of general ventilation;

- Minimisation of manual phases;

- Avoidance of contact with contaminated tools and objects;

- Regular cleaning of equipment and work area;

- Management/supervision in place to check that the RMMs in place are being used correctly and OCs

followed;

- Training for staff on good practice;

- Good standard of personal hygiene;

- Substance/task appropriate gloves;

- Skin coverage with appropriate barrier material based on potential for contact with the chemicals;

- Substance/task appropriate respirator;

- Optional face shield;

- Eye protection.

9.0.9.3. Consumers.

No consumer assessment has been made, as there is no consumer related use for the substance,

resulting in exposure for consumers.

9.0.9.4. Man via environment.

Scope and type of assessment

The scope of exposure assessment and type of risk characterisation required for man via environment

is based on the hazard conclusions presented in the document draft RAC n° 33/1015/09 rev 1 and is

described in the following table. The risk assessment of man via the environment is mainly based on

the potential exposure of the general population via air as well as indirect oral exposure through

consumption of drinking water and/or various crops/food potentially contaminated with EDC

following its industrial emission at Grupa LOTOS industrial facility. Local and regional risk

assessment are conducted so to ensure all potential emissions are taken into account.

Table 7 - Type of risk characterisation for man via the environment.


characterisation

Hazard conclusion (see RAC n°33/2015/09 rev1)

Inhalation

Systemic Long Term Semi-quantitative According to the draft RAC conclusion, the excess

risk is calculated as follows:

Excess risk = exposure (µg/m3) x 3.45 10-6




Total

exposure

Systemic long term Semi quantitative The excess risk is calculated as follows:

Excess risk = exposure (µg/kg bw/d) x 1.2 x 10 -5




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1,2-dichloroethane CAS number:107-06-2


9.1 Exposure scenario 1: Use as an extraction solvent in the de-waxing ofpetroleum vacuum distillates and de-asphalted oil and de-oiling of slackwax for the production of base oils and paraffinic waxes.

9.1.1. Environmental contributing scenario 1: Use as an extraction solvent in the de-waxing of petroleum vacuum distillates and de-asphalted oil and de-oiling of slack waxfor the production of base oils and paraffinic waxes.

9.1.1.1. Exposure and risks for the environment and man via the environment.

A release factor for each environmental compartment is used to determine the fraction of the tonnagethat will be released to each environmental compartment i.e. water, air, soil. The Environmental ReleaseCategory (ERC) 4 i.e. industrial use of processing aids (solvent) in process and products, not becomingpart of articles is used to determine the default parameters used for the initial release rate calculation.The release estimation may then be refined using specific on-site data as Risk Management Measures(RMM) and Operational Conditions (OC) as well as measure data of the emission in air and wastewaters if available. Specific RMM are considered in this assessment as standard practice, theireffectiveness is known and controlled on-site. These abatement techniques are defined using the CEFICRMM library and their efficiencies are defined by the EU BREF Documents if needed. The use of suchabatements is supported by the compliance to the Industrial Emissions Directive (Directive 2010/75/EUof the European Parliament and of the Council of 24 November 2010 on industrial emissions, integratedpollution prevention and control).

The on-site specific RMMs, defined with the best available technologies (BAT referenced in EU BREFDocuments), are each assigned with a quantitative measure of release reduction and are used in thequantitative assessment in association with the initial default release factors to determine the actualrelease factor when needed.

When analytical results in influent/effluents or in the air phase as close as possible from the emissionsource are available, these will be used to back calculate the removal efficiency in the air phase or inthe wastewaters.

At its industrial site of the Grupa LOTOS, EDC is used as de-oiling and de-waxing solvent at theirunique site in Poland (Grupa LOTOS S.A.; ul. Elbląska 135; 80-718 Gdańsk, Poland).

9.1.1.1.1 Conditions of use.

The conditions of use for the industrial production using EDC is indicated in the following table forassessment of the impact of the general population via the environment.

Conditions of use of EDC at Grupa LOTOS facility

Amount used, frequency and duration of use (or from service life)

• In the system there is ca. tonnes of EDC. Annual amount used in the circulation loop at asite continuous process corresponding to ca. tonnes/year.

• Annual tonnage of substance consumed at site used for risk assessment: see mass balance“chapter 9.1.1.1.3. Releases”.

• Emission day: 344 operating days every three or four years (3 weeks of annual maintenance break).For risk assessment purposes 344 operating days will be used as it represents a worst case situation.

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9.1.1.1.2. Monitoring data.Monitoring data of the concentration of EDC in waste waters out of the production plant.

The discharge in waste waters through the different units is described below.

In summary, the waste waters; the process waters (used directly in the process) and oiled rainwaters(coming from paved production areas) are discharged into the river Martwa Wisła (see below discharged points “12”) whereas the drainage waters coming from the refinery’s drainage system

Conditions and measures related to sewage treatment plant

• Onsite STP discharge to a channel (Rozwójka) discharging to the river Martwa Wisła (close to Gdańsk) directly discharging down to the sea. Because the river Martwa Wisła is a dead arm of the Vistula river discharging directly to the sea, it is estimated that the discharge is down directly to theBaltic Sea.

• Discharge rate of onsite wastewater treatment plant: in 2014 13380 m3/d (value used for riskassessment); in 2015 3116.9 m3/d

• Receiving surface water flow rate (Martwa Wisła): dilution 10 (default value)

Other conditions affecting environmental exposure

Expected for distillation solvent recovery unit (80 to 130°C), all the process phases are under ambienttemperature or low temperature (-4°C after the first dilution, -18°C after second dilution). The sealsof the rotary equipment are mainly single but the process of replacing them with the double-axial faceseal with barrier fluid is under execution. All transfers (storage tank, mixing vessels, filtration,distillation) are automatized and under panel control and alarms. In case of emergency all the unit isconnected with a secure unit tank storage. All equipment is outside building excepted rotary drumfilters.

Conditions and measures related to treatment of waste

Air treatment:

All equipment of de-waxing and de-oiling facility unit is connected to a general vent-gas balancevessel (Gasometer tank) to ensure regular pressure in the unit and to avoid direct releases.

Waste Water treatment:

After condensers and water/solvent separation vessel, waste water is treated in a stripper column. Afterthis stripper column treatment the water is sent to the general chemical waste water treatment unitplant.

- Water stripping column treatment

o Unique number for CEFIC library of RMM / OC: E13.19 (no default value defined; maximum

achievable removal efficiency 99.5%)

o BAT Reference Document ‘Common Waste Water and Waste Gas Treatment/Management

Systems in the Chemical Sector’, page 126

- On-site chemical (flocculation) and biological WWTP

o Unique number for CEFIC library of RMM / OC : E13.21 (no default value for non-

biodegradable compounds)

o BAT Reference Document ‘Common Waste Water and Waste Gas Treatment/Management

Systems in the Chemical Sector’, page 138 (efficiency based on COD measurement and

therefore not directly applicable to EDC)

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lowering the groundwater level under the production site and rain waters (from paved non production

area) are discharged into a channel called Rozwójka (discharged point “1”) which also discharged into

the river Martwa Wisła (see below):

Figure 4 - Discharge points at Grupa LOTOS Facility

The different processes are summarized below.

Figure 5 - Concentrations of 1,2-DCA and DCM (μg · L-1) at different locations in the petrochemical

plant. Sampling points 1–3 are located at the dewaxing unit, whereas points 4–9 are at the WWTP.

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Table 8 - Description of sampling points and measured water temperature.

The monitoring of the EDC concentration in the effluents is showing the following results according

to the published results):

The inlets of the waste water treatment plant contains EDC up to few hundreds µg/L as well as

samples collected in drainage waters. No EDC concentration in the discharged waters were

determined.

The analytical technique performance and the sampling events are indicated below:

Analytical method DAI-GC-ECD (see reference 1)

Limit of quantification 1 µg/L

Limit of detection 0.33 µg/L

Blank concentration < LOD

Recovery 96%

Accuracy 3.90%

Reproducibility 5%

Sample collection 9 grab

Sampling frequency and pattern Every two weeks/once a month

In addition, there is a monitoring in place organised by the plant every month showing the same

results i.e. less than LOD with the same method as above.

Reference 1: Tobiszewski M., Namieśnik J. (2011); Determination of chlorinated solvents in industrial

water and wastewater by DAI-GC-ECD; Anal. Bioanal. Chem 399: 3565-3572.

Monitoring data of the concentration of EDC potentially released in the air phase

The potential release of EDC in the air phase in the vicinity of the industrial plant may be estimated

using modelling. It is anticipated that modelling may represent a worst case situation and in general

some default assumptions are used. However in order to refine and get more accurate data of the

concentrations of EDC following its potential release in the air phase, a monitoring program was set

up. Objective was to measure the concentration of EDC both in gaseous form and in the atmospheric

deposit.

Measurement set up

The following trapping agents were used:

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Atmospheric deposit: Bergerhoff gauges samples;

Gaseous concentration: Radiello passive tubes.

The analytical method is based on GC-MS methodology (see below for reference).

Reference text

Comment

Normative reference NF X43-014

« Determination of the total

atmospheric deposition »

Bergerhoff gauges samples

HS/GC/MS EDC analyses following NF ISO

11423-1 and NF EN ISO 10301

Internal method

Passive tubes sampling.

GC/MS EDC Analysis

Radiello passive tubes

Methodology

The sampling strategy was developed jointly between Grupa LOTOS, SOCOTEC and CEHTRA and

provides three sampling areas in residential areas. These areas are represented on the map below

(numbers 1, 2 and 3).

Three locations have been chosen up taken into account the wind directions (see below the wind

roses) i.e. mainly direction East and South and West of the production plant.

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Figure 6 - Design of the air sampling devices.

Each area has been equipped with 9 Bergerhoff gauges (3 gauges by 3 times repeated trials) and 3Radiello passive tubes.

Area / point number 1 2 3Point nameGPS Location 54°20’50,01’’ N /

18°42’46,86’’ E54°21’15,24’’ N /18°44’59,70’’ E

54°20’22,27’’ N /18°44’17’’ E

Figure 7 - The different sampling points of the setting up of the Bergerhoff and Radiello samplings.

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Results

Atmospheric depositions

Point number 1 2 3Point namePoint reference PT1-E1/E2/E3 PT2-E1/E2/E3 PT3-E1/E2/E3Exposure period from 26/10/2015 14:40 27/10/2015 09:40 26/10/2015 14:00to 10/11/2015 11:00 10/11/2015 10:15 10/11/2015 09:30Exposure time (days) 14,85 14,02 14,81Exposure surface (m²) 0,00622 0,00622 0,00622Average EDC amount collected (µg) <0,267 <0,275 <0,204Average exposure (µg/m²/day) <2,9 <3,2 <2,2

* All values are below the LOQ (calculated on the basis of 1 µg/L), no peak has been detected. As theLOD is 0.33µg/L, the average exposure used for risk assessment is therefore:

Point Number 1 2 3Average exposure (µg/m2/day) < LOD (0.966) < LOD (1.066) <LOD (0.733)

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Diffusive concentrations

Point number 1 2 3Point namePoint reference PT1-E1/E2/E3 PT2-E1/E2/E3 PT3-E1/E2/E3Exposure period from 26/10/2015 14:40 27/10/2015 09:40 26/10/2015 14:00to 10/11/2015 11:00 10/11/2015 10:15 10/11/2015 09:30Exposure time (days) 14,85 14,02 14,81Average concentration (µg/m3) <1,3 <1,4 <1,3

* All values are below the LOQ, no peak has been detected. The LOD is 0.43µg/m3

Point Number 1 2 3Average concentration(µg/m3)

< LOD (0.43) < LOD (0.43) <LOD (0.43)

Conclusion.The EDC collected in Bergerhoff gauges is very low, under limit of quantification and even limit ofdetection. Considering that collected EDC might have been evaporated from the gauges, the passivetubes positioned near gauges would have adsorbed this EDC in gaseous form.As concentrations of EDC on passive tubes are also low, it confirms that no detectable EDC depositoccurs during the 2 weeks campaign.We can conclude that diffusive EDC amount emitted by unit 1300 is so low that the EDC concentrationsin plant surrounding area (in selected sampling sites) were under limit of detection.

9.1.1.1.3. Releases.

There is in place an improvement plan in order to reduce (among others) the fugitive emission in theair phase. The table below is showing the mass balance of EDC per year.

Tonnes / year CommentEDC Tonnes involved per year : In the system there is ca. tonnes

of EDC, Annual amount used in thecirculation loop at a site continuousprocess corresponding to ca.tonnes/year.

EDC Tonnes purchased in 2015:

neutralisation: Based on calculationsolubilizing and corrosion(corrosion products FeCl3 from sediments)

It is estimated value every 4 years (the lastone comes from 2013)

in water before treatment Based on measurement (Tobiszewski M.,from 2010 to 2011.)

in water after treatment Based on measurement (Tobiszewski M.,from 2010 to 2011.)

into finished products estimation

in hydrocarbons slops estimationin air - fugitive emission estimation

– unpredictable sporadic incident This is estimated value which is still underdevelopment according to IMPROVEMENTPLAN.

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• comes from sporadic defected work of:rotary equipment single seals, controlvalve seals

• leakage that comes from corrosion indrum filters and pipelines

• leak at flanges• data t/y based on the emission

measured in 2002 year concerns theemission of EDC when the 1300 Unitwas in better technical condition

Table 9 - Local release rate of EDC in the different environmental compartments following its industrialuse at Grupa LOTOS facility.

Release Release factor estimationmethod

Explanation / Justification

Water ERC based Initial release factor: 100% (ERC 4)Initial local release rate: 42.82 kg/day (14 730 kg.year-1/344operating days)Final local release factor:Emission in water equivalent to 9.27 10-3 kg/dJustification: the above release factor is calculated using EUSES2.1.2 leading to a concentration of EDC in the STP effluents of0.33 µg/L

Air ERC based Initial release factor: 100% (ERC 4)Initial local release rate: 42.82 kg/dayFinal local release factor:Equivalent Emission in the air phase: 1.55 kg/dJustification: The release factor is back calculated using EUSESbased on measured concentration of 0.43 µg/m3 i.e. the LOD ofthe measured concentration in the air phase. The release factorbased on total deposition flux during the emission episode wouldlead to a higher concentration in air, what is not observed.

Soil ERC based Initial release factor: 5% (ERC 4)Final release factor: 0Local release rate: 0 kg/day. No release of contaminated sludgeonto agricultural soils.

Following the calculation of the theoretical release factors based on measured data, the potentialcontamination of the different environmental and biological media are calculated using EUSESsoftware.

The indirect exposure of the general population is assessed on two spatial scales: locally near a pointsource of the substance, and regionally using averaged concentrations over a larger area. In the localassessment, all food products are derived from the vicinity of one point source, in the regionalassessment, all food products are taken from the regional model and certainly represent a worst casesituation. These two scenarios (local and regional scale) are considered appropriate and conservativeenough for the first approach to indicate possible concern for further evaluation if necessary.

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Exposure via the environmental compartments.

The exposure concentrations of EDC related to the potential exposure of the general population

through environment is calculated with EUSES software (version 2.1.2).

The input values related to EDC and its physicochemical properties are extracted from the registration

dossier and from literature. These are summarized below:

Table 10 - EDC-physicochemical data, environmental properties and environmental partition

coefficients used as input values in EUSES software and related environmental partition coefficients.

End points Values Reference

Molecular weight 98.96 g/mol REACH Dossier

Melting point -35.35 °C REACH Dossier

Boiling point 83.6 °C REACH Dossier

Vapour pressure at 25°C 1.02 104 Pa REACH Dossier

Octanol-water partition coefficient 1.45 (log10) REACH Dossier

Water solubility at 25°C 7.9 103 mg/L REACH Dossier

Organic carbon-water partition

coefficient

33 L/kg Chiou, C.T., L.J. Peters, and V.H. Freed. 1979. A

physical concept of soil-water equilibria for non-

ionic organic compounds. Science. 206:831-832

Henry's law constant at 25 [oC] 128 Pa.m3.mol-1 Calculation

Bioconcentration factor for fish 2 Evaluated by the report: Intermedia Transfer

Factors for Contaminants found at Hazardous

Waste Sites DCA from Risk Science Program,

Univ. California, Dec. 1994.

Rate constant for abiotic degradation

in STP

0 Default value (EDC is not classified as

biodegradable)

Rate constant for hydrolysis in surface

water (DT50; 25°C)

1000 days (default

value)

Default.

Rate constant for photolysis in surface

water (DT50)

1000 days Default.

Total rate constant for degradation in

bulk surface water (DT50)

430 days Evaluated by the report: Intermedia Transfer



Univ. California, Dec. 1994.

Rate constant for degradation in air

(DT50)

41.9 days Simulated by AOP Program v.1.92.

Rate constant for biodegradation in

soil (DT50)

110 days Evaluated by the report: Intermedia Transfer



Univ. California, Dec 1994

Total rate constant for degradation in

bulk sediment

0 Used as default.

Table 11 - Set up of parameters used for risk assessment using EUSES.

Parameters Values Comments

Fraction of EU production volume for

region

20 % -

Fraction of EU Tonnage for region

(private use)

0% -

Fraction connected to sewer systems 100% -

STP: Mode of aeration Surface -

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Exposure in air and surface water.

The detailed calculation outcome is indicated in Appendix 5 and a summary is given hereafter.

The exposure concentrations calculated with EUSES are reported in the following tables with the

main results. The calculated concentration in air and in surface water is indicated below:

Predicted environmental concentration of EDC (PECs) in air and surface waters

Regional PEC in air (total): 2.59 10-08 mg/m3

Annual average local concentration in air, 100 m from point source: 3.97 10-04 mg/m3

Regional PEC in surface water (total): 7.4 10-09 mg/L

Annual average local PEC in surface water (dissolved): 3.32 10-05 mg/L

Exposure via drinking water.

There is no possibility to contaminate drinking water from the two discharged points:

- the ROZWÓJKA river which flows into the Martwa Wisła and

- the MARTWA WISŁA river, which is not a regular river – its waters are salty so it cannot be used

as drinking water.

Following emission in air of EDC, the re-deposition in soil in the form of aerosol bound or gaseous

form may occur. The deposition is calculated using the software OPS (included also in the EUSES

software) subsequently in the pore water (calculated by dividing the concentration in soil by the soil

adsorption coefficient).

The concentration of the tested substance in drinking water is estimated by the maximum of the

concentration in the soil pore water following re-deposition onto soil and the concentration in surface

waters. In the present case the highest calculated concentration is calculated from the concentration of

EDC in the soil pore waters.

The resulting calculated concentrations in soil and in waters are indicated below:

Regional PEC in agricultural soil (total): 9.1 10-10 mg/kg

Local concentration in agricultural soil over 180 days: 6.67 10-05 mg/kg

Regional PEC in pore water (agricultural soils): 1.29 10-09 mg/L

Local PEC in pore water of agricultural soil: 9.61 10-05 mg/L

Local PEC in groundwater under agricultural soil: 9.61 10-05 mg/L

Local concentration in drinking water: 9.61 10-05 mg/L

Exposure via food consumption.

Assessing concentrations in food products (in this context fish, leaf crops, root crops, meat and dairy

products) is based on the estimated bio-transfer from soil and air to plants. The major

physicochemical parameter impacting the concentration into the different media is the bio-

concentration value (BCF). EDC is typically a compound with low bioaccumulation potential and

secondary poisoning is excluded. Plant products form a major part of the food products for humans

and cattle. Contamination of plants will therefore have significant influence on the exposure of

humans.

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Total daily intake for the general population.

The total daily intake of humans can be estimated from the daily intake rate of each medium by

summing the contribution of each medium (drinking water, milk, meat, crops etc.) and using daily

human doses.

The following results are then obtained:

Daily human doses (LOCAL)

Daily dose through intake of drinking water 2.75 10-06 [mg.kg-1.d-1]

Daily dose through intake of fish 1.01 10-07 [mg.kg-1.d-1]

Daily dose through intake of leaf crops 3.37 10-07 [mg.kg-1.d-1]

Daily dose through intake of root crops 6.69 10-07 [mg.kg-1.d-1]

Daily dose through intake of meat 1.88 10-10 [mg.kg-1.d-1]

Daily dose through intake of milk 3.51 10-09 [mg.kg-1.d-1]

Daily dose through intake of air 1.13 10-04 [mg.kg-1.d-1]

Local total daily intake for humans 1.17 10-04 [mg.kg-1.d-1]

Daily human doses (REGIONAL)

Daily dose through intake of drinking water 1.06 10-10 [mg.kg-1.d-1]

Daily dose through intake of fish 2.43 10-11 [mg.kg-1.d-1]

Daily dose through intake of leaf crops 2.20 10-11 [mg.kg-1.d-1]

Daily dose through intake of root crops 9.01 10-12 [mg.kg-1.d-1]

Daily dose through intake of meat 1.18 10-14 [mg.kg-1.d-1]

Daily dose through intake of milk 2.20 10-13 [mg.kg-1.d-1]

Daily dose through intake of air 7.40 10-09 [mg.kg-1.d-1]

Regional total daily intake for humans 7.56 10-09 [mg.kg-1.d-1]

The main fraction of the daily intake is being represented on the local scale on the exposure to

contaminated air originating mainly from direct emission in the air phase.

Based on these values, the risk assessment can then be finalized using the toxicological end points of

EDC. Exposure to the general population via the environment is considered to be of low concern, for

the local and regional assessment when: - all Life Cancer Risks (LCRs) < 10-6.

The following risk assessment outcome is then obtained.

The exposure concentrations as calculated with EUSES 2.1.2 are reported in the following table

together with the risk assessment outcome.

Table 12 - Risk assessment of the potential contamination of the general population from the

environment.

Protection target Risk characterization local Risk characterization regional

Man via

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Protection target Risk characterization local Risk characterization regional

Environment –

Inhalation and total

exposure

CLR exposure via air = 1.37 10-06

CLR total exposure = 1.40 10-06

CLR exposure via air = 8.94 10-11

CLR total exposure = 9.07 10-11

CLR: Cancer life risk

Conclusion

From the measurements of the measured concentration in the air phase as well as the deposit over a

two weeks campaign, it is clear that the major contributor of the potential risk towards the general

population is the potential release in the air phase from the industrial production involving EDC at the

Grupa LOTOS site. Although in the present monitoring study of concentration of EDC in the air

phase no EDC peak was observed, risk assessment based on the limit of quantification is considered

as a worst case situation and an improvement of the analytical methods in terms of detection will

improve the results of the risk characterization.

EC number:

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9.1.2. Worker contributing scenario 1: Production process including storage, transfers,

recycling, waste transfers (PROC 2).

As described in the introduction of chapter 9.0, the processes using EDC are closed systems without

direct handling of EDC by operators except during EDC sampling for QC (not covered by WCS1 but

covered by WCS2, see next chapter).

The contributing scenario WCS1 covered all phases where EDC is used or transferred in closed

system equipment: storage tank, crystallisation vessels, filters, distillation reactors, recovered EDC

storage tanks.

9.1.2.1. Conditions of use.

Product characteristics

• 1,2-dichloroethane – liquid

Amount used, frequency and duration of use/exposure

• The industrial sites are producing in continuous process, 24/24, all year (only 3 weeks every 4 years

maintenance break). As described below the processes using EDC are closed systems without direct handling

except during QC sampling (see WCS2).

Technical and organisational conditions and measures

• All equipment and processes from production units involving EDC is under closed systems. All of the

columns, vessels are equipped with the control systems i.e. level, pressure, temperature control devices. The

seals of the rotary equipment are mainly single but the process of replacing them with the double-axial face

seal with barrier fluid are under execution. The drained streams which contain EDC are collected in the close

drain vessel and are reprocessed in the unit. In case of emergency, the equipment is connected to the buffer

vessels located on the unit. The buffer vessels are under filtration gas blanket.

• Local exhaust ventilation: none

Conditions and measures related to personal protection, hygiene and health evaluation

• Dermal Protection: No (except during sampling for QC, see WCS2 below) - see material and justification in

chapter 9.0.9.2

• Respiratory Protection: none

Other conditions affecting workers exposure

• Place of use: Indoor (good general ventilation) and outdoor

•Trained and authorized person: General training on risks for chemical are given each years for all operators

involved in chemical handling. Specific trainings on chemical risk handling are given regularly to all plant

operators handling EDC. All tasks involving EDC handling are done by competent and authorized operators.

9.1.2.2. Exposure and risks for workers.

The WCS1 (PROC2) is covering a full shift operation (8 hours). The operator functions are described

below:

Employees working in the units using EDC = 15.

i.e. three operating positions per shift. Not the same operators are still working for the 1300 Unit.

It means that an annual exposure of EDC for every particular person can be less because of

operators rotation between all units of Lube Oil Complex. The value 15 operators is related to a

required operating positions.

Description of the shifts working in the unit using EDC :Those employees are in 5 teams (3 operators by team). Per day (24/24): Team1 = shift 1: 6:00 to 14:00;

Team2 = shift2: 14:00 to 22:00; Team3 = shift3: 22:00 to 6:00. Frequency of WCS1 = all year. The

tasks done by operators are facility supervision, control from the room panel control, visual control

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routines on unit.

Operators from this WCS1 are not the same operators working in WCS3 (unloading road tank), WCS4

(non-routine maintenance), WCS5 (general maintenance) and WCS6 (laboratory). Operators from

WCS1 are the same operators as those working in WCS2 (sampling for QC) – see chapter 10 for

combined exposure.


As described in chapter 9.0.9.2, a specific measurement campaign has been conducted in October

2014 and October 2015 by an external certified laboratory, SOCOTEC Industries. A total of 10

measurements (6 in 2014, 4 in 2015) have been used for exposure calculation (see details in appendix

2). The 90th percentile result is 0.37 mg/m3 (recalculate on TWA 8h).

Other existing data: measured campaigns have been done in 2009, 2010 and 2013 by internal

laboratory (1 measured point every year). The results are: 2009, <5 mg/m3; 2010, <7.1 mg/m3, 2013,

<5 mg/m3 (EDC results on TWA 8h). Grupa LOTOS conclusions on those results are: “Since EDC

concentration is below 0.1 Highest Acceptable Level (Polish regulation) there is no necessity to do

further measurements according to Polish regulations. However Grupa LOTOS does such

measurements every 2-3 years.” Due to high LoQ (technical analyses not communicated), those

results can’t be taken into account in exposure calculation.


The dermal exposure will occur only during the QC sampling task (see WCS2 below).

No dermal exposure is expected during the other tasks in WCS1 (closed system).

Table 13 - Exposure concentrations and risks for workers.

Route of

exposure and

type of effects

Exposure concentration

(Time Weighted Average 8

hour exposure)

Correction factor

for frequency

Risk characterisation

Inhalation,

systemic, long-

term

0.37 mg/m3 **

(measured data 90th percentile, see

appendix 2)

Frequency: 1*

Excess cancer risk:

2.22 E-4

Dermal,

systemic, long-

term

- -

Combined routes,

systemic, long-

term

Excess cancer risk:

2.22 E-4

* Frequency: activity takes place on daily basis; correction factor = 1.

** no RPE used by operators.

Conclusion on risk characterisation

The derived excess cancer risks for systemic, long term effects due to inhalation and dermal contact

are considered to be the lowest achievable risks, following the minimisation principle described in

conditions of use and risk management measures of this contributing scenario.

EC number:

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9.1.3. Worker contributing scenario 2: EDC sampling from quality control (PROC 8b).





• amount = 250 ml of 100% EDC per sampling.

• frequency = 1 per day.

• duration < 5 minutes.


• Containment: closed system – closed loop sampling



• Dermal Protection: Yes (chemically resistant gloves KCl/ nitrile conforming to EN374 with specific activity

training) (Dermal: 95%) – see material and justification on page 20.

• Respiratory Protection: none


• Place of use: Outdoor

•Trained and authorized person: General training on risks for chemical are given each year for all operators



Photo 7 – EDC Sampling.

Operator opens valves on the inlet and outlet of sampling bottle. When pressure on manometer no

longer increase, sampling bottle is full with mixture of solvents. Operator closes valves and

disconnects the bottle from the system. He leaves the sampling bottle in the box situated on the

entrance of the production unit, from where are taken by laboratory worker (sorter) to laboratory.

__________________________________________________________________________________

EC number:

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The WCS2 is covering a specific operation of EDC sampling for quality control. A sampling of EDC

(100%) is done for quality control purposes at a frequency of 1 per day (24h). The location is outside.

250 ml of EDC are sampled in a sample cylinder from the closed loop sampling (vent and non-return

valves, flexible hoses with quick disconnect coupling for better operator safety) (closed sampling

process, see photo 7). After filling, the sample cylinder (hermetically closed) is sent to laboratory. The

sampling duration is less than 5 minutes.

Operators from this WCS2 are not the same operators working in WCS3 (unloading road tank),

WCS4 (non-routine maintenance), WCS5 (general maintenance) and WCS6 (laboratory).

Operators from WCS2 are same operators as those working in WCS1 – see chapter 10 for combined

exposure.


During the 2014 and 2015 campaign (see WCS1), 6 measures were done during the specific QC

sampling task (see details in appendix 2). The 90th percentile result is 0.11 mg/m3 (recalculate on

TWA 8h). No respiratory protective equipment is used during the sampling task.


The dermal exposure will occur during the QC sampling task (1 per day, duration 5 min, flask 250 ml,

closed loop sampling, outside, gloves efficiency 95%).

Justification of Riskofderm inputs (see details in appendix 4, table 4.I): the most relevant Riskofderm

existing activity to cover sampling is “filling, mixing or loading”. “Rare contact” and “Light contact”

have been chosen because the operator is not in direct contact with EDC during sampling (closed loop

sampling) and there is no potential for splashing during this operation. The use rate is 0.1 l/min which

is representative of sampling flask operation. The duration is 5 minutes. The 90th percentile result is

4.53 E-3 mg/kg/d (using PPE 95% efficiency).

Table 14. Exposure concentrations and risks for workers.

Route of

exposure and

type of effects


(Time Weighted Average 8 hour

exposure)

Correction

factor for

frequency


Inhalation,

systemic, long-

term

0.11 mg/m3 **

(measured data 90th percentile, see

appendix 2)

Frequency: 0.33*

Excess cancer risk:

2.18 E-5

Dermal,

systemic, long-

term

4.53 E-3 mg/kg/d ***

(Riskofderm, 90th percentile)

Frequency: 0.33*

Excess cancer risk:

3.15 E-6

Combined routes,

systemic, long-

term

Excess cancer risk:

2.50 E-5

* Frequency: sampling task is one each 24 hours (all year). As there are 3 shifts per 24 hours, the frequency

correction factor is 0.33.

** no RPE used by operators

*** PPE used during the full task then 95% for dermal have been used to recalculate exposure (see justification

chapter 9.0.9.2)

Inputs data and results used in Riskofderm for dermal exposure calculation: see appendix 4.

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EC number:

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9.1.4. Worker contributing scenario 3: Receive of EDC from rail tank (PROC 8b).



• 1,2-dichloroethane – liquid Quantitative measures


• Every 2 years, tonnes of EDC are unloaded from rail tank to storage tank. The

complete duration of this operation is less than 3 hour. 2 operators are doing the

work which consists of:

- opening the manhole on the top of rail tank and taking a sample with a

dedicated cane. The flask of 200 ml is hermetically sealed after sampling

and sent to laboratory – sampling duration < 5mins.

- connecting the flexibles from road tank to storage tank (previously purged

with nitrogen gas) – duration 2 mins

- Visual control during unloading (far-off road tank, >20 m) - duration <

170mins

- Disconnecting the flexibles (previously purged with nitrogen gas – no

residual EDC expected) – duration 2 mins.


• Containment: fixed connection and hose steel connections. Fixed connection and

hose steel connections with gas offtake at a safe point / transfer to general vent gas

treatment system – no direct emission to atmosphere.

• Assurance of leak-proofness by leak test after establishing the connection and

complete capture of the residual quantities by inert gas into the flexibles



• Dermal Protection: Yes (chemically resistant gloves KCl 890 / Fluorocaoutchouc

conforming to EN374 with specific activity training) (Dermal: 95%) – see material

and justification in chapter 9.0.9.2

• Respiratory Protection: Yes, full face mask A2B2E2K2HgP3 [Effectiveness

Inhal: 95%] during sampling and connection/disconnection.


• Place of use: Outdoor

•Trained and authorized person: Connection and transfer is done by employees

competent, trained and authorized for EDC unloading tank operations.

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Photo 8 – unloading EDC flexibles.

Photo 9 – Personal Protective Equipment during unloading operations.


The WCS3 is covering a specific operation of rail tank EDC unloading. WCS3 is done by unloading

operator team (frequency once every 2 years).The task covering WCS3 is done in less than 3 hours.

After an EDC unloading rail tank operation, the operator will no longer be exposed to EDC for the 4

remaining hours of the working day (in general in charge of other chemical unloading operations).

Operators from this WCS3 are not the same operators working in WCS1, WCS2, WCS4, WCS5 and

WCS6.


As there is no measurement data regarding WCS3, a tier 2 model assessment approach using

Advanced Reach Tool (V1.5) has been used (see all details of ART inputs in appendix 3). In ART we

have used 3 activities (equivalent to operation phases during the task) to cover the complete task of

road tank unloading:

EC number:

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- Activity 1 = sampling of EDC on rail tank – duration 5 mins.

- Activity 2 = connection/disconnection flexibles – duration 5 mins (total duration connecting

and disconnecting)

- Activity 3 = road tank unloaded – duration 170 mins.

(No exposure period = 300 min – other tasks during the day – no EDC).

Justification of inputs used in ART model:

Activity 1. Emission source located in the breathing zone of the worker. The activity class is transfer of

falling liquid with a flow of 0.1 to 1 l/min which is relevant for bottle sampling with a cane. Splash

loading has been chosen with no localised controls and no containment (worst case). The predicted 90th

percentile exposure during the 5 mins of activity 2 is 78 mg/m3 (result without PPE efficiency). The

exposure result considering PPE efficiency 95% will be 3.9 mg/m3 for activity 1.

Activity 2. Emission source located in the breathing zone of the worker. During this phase the

operator is connecting/disconnecting a flexible hose, and so handling of a contaminated object

is a more appropriate activity class in this case. The complete surface of connection of the

flexible is between 0.1 and 0.3 m2. As the flexible hoses are purged with nitrogen gas, the

ART input “contamination <10% of surface” is relevant. No localised controls and no

containment chosen in ART (worst case). The predicted 90th percentile exposure during the 5 mins of activity 2 is 26 mg/m3 (result without PPE

efficiency). The exposure result considering PPE efficiency 95% will be 1.3 mg/m3 for activity 2.

Activity 3. During this phase, the operator is far away from the road tank (>20 m). The ART

activity class is bottom loading with a 100-1000 l/min. The general control measures “vapour

recovery systems” has been chosen as there is gas offtake at a safe point / transfer to general

vent gas treatment system – no direct emission to atmosphere. The predicted 90th percentile exposure during the 170 mins of activity 2 is 1.7 mg/m3 (result without

PPE efficiency as no inhalation PPE used for activity 3).

The predicted 90th percentile exposure for the unloading road tank (activity 1, 2 and 3) of 180 min is:

(Expo act1 x t1 + Expo act2 x t2 + Expo act3 x t3)/(t1+t2+t3) = (3.9x5 + 1.3x5 + 1.7x170) / 180 =

1.75 mg/m3.

The predicted 90th percentile 8h based exposure result from ART is 0.66 mg/m3 for WCS3.


As described above there are three main phases during the unloading operation: sampling,

connecting/disconnecting of flexible hoses and unloading. We can consider that during the unload

phase there is no dermal exposure as the operator is only doing a visual inspection. Regarding

sampling and connecting/disconnecting flexible hose phases, the tier2 model Riskofderm has been

used for dermal exposure assessment. Justification of Riskofderm inputs (see details in appendix 4): Activity 1 – sampling rail tank from manhole. The most relevant Riskofderm existing activity to cover

sampling is “filling, mixing or loading”. “More than rare contact” and “more than light contact” have

been chosen because the operator is in direct contact with the sampling cane and there is potential for

splashing during this operation. The input “significant amounts of aerosols or splashes” is also chosen.

The use rate is 0.1 l/min witch is representative of sampling flask operation. The exposure duration is 5

minutes. The 90th percentile result of activity 1 is 0.14 mg/kg/d (using PPE 95% efficiency).

Activity 2 – connection/disconnection of flexible hoses. In Riskofderm model there is no specific

activity covering connection/disconnection of flexible hoses. From the 6 existing activity (filling-

mixing-loading, wiping, dispersion with hand tool, spraying, immersion, mechanical treatment),

“filling-mixing-loading” is the most relevant. As the flexible hoses are purged with nitrogen gas before

connecting or disconnecting operation, we can consider a use rate (“product handled per min”) of 0.05

l/min as worst case (covering the potential but not expected residual EDC). “Light contact” has been

chosen as the operator is handling purged flexible hoses. “More than rare contact” has been chosen as a

worst case situation. The input “no significant amounts of aerosols or splashes” also chosen as no

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splashes or aerosol expected due to nitrogen purge. The dermal exposure duration is 5 minutes

(potential dermal exposure only during connecting/disconnecting flexible hoses). The 90th percentile

result of activity 2 is 8.0 E-3 mg/kg/d (using PPE 95% efficiency).

The total dermal exposure (covering activity 1, 2 and 3) is: (0.14 + 8.0E-3) = 0.15 mg/kg/d (using

PPE 95% efficiency).


Route of

exposure and

type of effects



exposure)

Correction

factor for

frequency


Inhalation,

systemic, long-

term

0.66 mg/m3 **

(tier 2 ART model, 90th

percentile)

Frequency: 0.0021*

Excess cancer risk:

8.32 E-7

Dermal,

systemic, long-

term

0.15 mg/kg/d**

(Riskofderm, 90th percentile)

Frequency: 0. 0021*

Excess cancer risk:

6.61 E-7

Combined routes,

systemic, long-

term

Excess cancer risk:

1.49 E-6

* Frequency: activity takes place every 2 years (240d); correction factor = 0.0021

** PPE used during the full task then 95% efficiency for inhalation and 95% for dermal exposures have been

used to recalculate exposure (see justification chapter 9.0.9.2)

Input data and results used in Riskofderm for dermal exposure calculation: see appendix 4.





EC number:

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107-06-2


9.1.5. Worker contributing scenario 4: Non routine maintenance and cleaning (PROC

8b).

This contributing scenario addresses non-routine equipment maintenance (e.g. small repairs, pump

dismantlement, filter change). These activities in general last no more than 15 minutes. They are

typically undertaken with a frequency of once per month as maximum.





• The non-routine maintenance frequency is around once per month.


Non-routine maintenance (= maintenance only in case of dysfunction of equipment (e.g. pump), on an

average of once a month): In case of equipment dysfunction or equipment change, operator from the plant unit

is in charge of connecting secondary equipment (e.g. pump) when relevant. These actions are on/off valve

actions. The unit operators are not authorized to dismantle equipment. This task will be done by maintenance

operators and as for general maintenance, the equipment is flashed and purged. The description of the

maintenance work to be accomplished as well as the specific risk management measures to follow are

described in a permit procedure. Personal Protective Equipment is mandatory (inhalation full mask

A2B2E2K2HgP3 and Chemical resistant gloves KCl 890 / Fluorocaoutchouc - see details page 20). If no

failure equipment detected, no cleaning or maintenance is done on equipment (except general maintenance).



• Dermal Protection: Yes (chemically resistant gloves KCl 890 / Fluorocaoutchouc conforming to EN374 with

specific activity training) (Dermal: 95%) – see material and justification in chapter 9.0.9.2

• Respiratory Protection: Yes, full face mask A2B2E2K2HgP3 [Effectiveness Inhal: 95%]


• Place of use: Indoor – good general ventilation

•Trained and authorized persons: General training on risks for chemical are given each years for all operators



Photo 10 – example of non-routine maintenance – seal replacement.

To take control valve to non-routine maintenance (for example seal replacement), mechanics unscrew six screws

on each flange (sign with red line) of the valve. Then mechanics clean the flange surface with brush and put the

new seal and recap the flange with screws. Possibility to contact with EDC is minimized by proper preparation

of control valve by operators according to internal procedures.

__________________________________________________________________________________________

EC number:

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The WCS4 is covering a specific operation of non-routine maintenance. WCS4 is done by

maintenance operators. The maintenance duration is 15 minutes per day. The frequency is on an

average of once a month. Maintenance operators from WCS4 are not the same operators working in

WCS1, WCS2, WCS3 and WCS6, but they are the same operators as WCS5 (combined exposure

results in chapter 10).


As there are no existing measurement data regarding non routine maintenance operations, a tier 2

model assessment approach using Advanced Reach Tool (V1.5) has been used (see all details of ART

inputs in appendix 3): in ART we have used 1 activity (equivalent to operation phases during the task)

to cover the complete task of maintenance:

o Activity 1 = maintenance – duration 15 mins (No exposure period = 465 mins)

Justification of inputs used in ART model: the ART input “main component” (50 to

90% EDC in the residual liquid) will be used to cover situations where the equipment

cannot be fully flushed. For maintenance operation it has to be considered that

emission source is located in the breathing zone of the worker (ART input). The

relevant activity description from ART for maintenance is handling of contaminated

objects with surface 1 to 3 m2 with a contamination of 10 to 90 % of surface (e.g.

dismantlement of pump equipment). No localised controls and no containment are

relevant ART inputs for maintenance operations. The small repair tasks of CS3 take

place in the production unit which correspond to large workroom.

The predicted 90th percentile full shift (8h) exposure result from ART is 33 mg/m3 (result without PPE

efficiency). The exposure result considering PPE efficiency 95% is 1.7 mg/m3.


The tier2 model Riskofderm has been used for dermal exposure assessment.

Justification of Riskofderm inputs (see details in appendix 4): in Riskofderm model there is no

specific activity covering maintenance operations. From the 6 existing activity (filling-mixing-

loading, wiping, dispersion with hand tool, spraying, immersion, mechanical treatment), “filling-

mixing-loading” is the more relevant for maintenance purpose. Also “More than rare contact” and

“more than light contact” have been chosen because the operator is in direct contact with the inside

part of the equipment. The input “significant amounts of aerosols or splashes” also chosen. As the CS

is covering small equipment maintenance the potential residual EDC handled rate will be less than 0.1

l/min (less than 1.5 litters of residual EDC handled during the 15 min task). The exposure duration is

15 minutes. The 90th percentile result is 4.05 E-1 mg/kg/d (using PPE 95% efficiency).


Route of

exposure and

type of effects



exposure)

Correction

factor for

frequency


Inhalation,

systemic, long-

term

1.7 mg/m3 **

(tier 2 ART model, 90th percentile)

Frequency: 0.05*

Excess cancer risk:

5.10 E-5

Dermal,

systemic, long-

term

4.05 E-1 mg/kg/d **

(Riskofderm, 90th percentile))

Frequency: 0.05*

Excess cancer risk:

4.26 E-5

EC number:

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Combined routes,

systemic, long-

term

Excess cancer risk:

9.36 E-5

* Frequency: activity takes place once per month (12/240); correction factor = 0.05

** PPE used during the full task then 95% efficiency for inhalation and 95% for dermal exposure have been

used to recalculate exposure (see justification chapter 9.0.9.2)

Input data and results used in Riskofderm for dermal exposure calculation: see appendix 4.


The derived excess cancer risks for systemic, long term effects due to inhalation and dermal contact are

considered to be the lowest achievable risks, following the minimisation principle described in conditions of use

and risk management measures of this contributing scenario.

EC number:

203-458-1


107-06-2


9.1.6. Worker contributing scenario 5: General maintenance and cleaning (PROC 8b).

This contributing scenario addresses annual large maintenance activities with full plant equipment

shut down.





• The general maintenance duration is 3 weeks every 4 years.


General maintenance: The general maintenance of equipment is done over 3 weeks every 4 years. Before any

equipment dismantling, the equipment is purged with solvent (DCM/EDC) until all wax is washed off. The

solvent is returned to the plant‘s feed (circulated in enclosed system). Then the equipment is purged with base

oil in order to bind and flush out solvent completely. The base oil used for purging is returned to the plant‘s

feed (circulated in enclosed system). The description of the maintenance work to do as well as the specific risk

management measure to follow are described in a permit procedure. Personal Protective Equipment is

mandatory (inhalation full mask A2B2E2K2HgP3 and Chemical resistant gloves KCl 890 / Fluorocaoutchouc

- see details page 20).



• Dermal Protection: Yes (chemically resistant gloves KCl 890 / Fluorocaoutchouc conforming to EN374 with

specific activity training) (Dermal: 95%) – see material and justification in chapter 9.0.2.2

• • Respiratory Protection: Yes, full face mask A2B2E2K2HgP3 [Effectiveness Inhal: 95%]


• Place of use: Indoor (good general ventilation) or outdoor

•Trained and authorized person: General training on risks for chemical are given each years for all operators



9.1.6.2. Exposure and risks for workers

The WCS5 is covering a specific operation of general maintenance. WCS5 is done by maintenance

operators. The maintenance duration is 1 to 6 hours maximum per day (the maximum duration of 6 h

will be used in exposure assessment as worst case). The general maintenance equipment is done over

3 weeks every 4 years (equivalent to 3.8 days per year = frequency of 0.016).

Maintenance operators from WCS5 are not the same operators working in WCS1, WCS2, WCS3 and

WCS6, but they are the same operators than WCS4 (combined exposure results in chapter 10).


As there is no existing measurement data regarding maintenance operations, a tier 2 model assessment

approach using Advanced Reach Tool (V1.5) has been used (see all details of ART inputs in appendix

3): in ART we have used 1 activity (equivalent to operation phases during the task) to cover the

complete task of maintenance:

o Activity 1 = maintenance – duration 360 mins (No exposure period = 120 mins)

Justification of inputs used in ART model: as before any dismantling, the equipment is fully

flushed and purged, the potential residual EDC will be extremely small (0.1 to 0.5 % - in the

equipment, residual % of EDC in the waste resulting from flushed and purged operation) (ART

input). For maintenance operation it has to be considered that emission source is located in the

breathing zone of the worker (ART input). The relevant activity description from ART for

EC number:

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maintenance is handling of contaminated objects with surface > 3 m2 with a contamination of 10

to 90 % of surface (e.g. opening equipment for vessel inspection). No localised controls and no

containment are relevant ART inputs for maintenance operations. Any size workrooms ART

input has been chosen to cover all workroom size cases.

The predicted 90th percentile full shift (8h) exposure result from ART is 22 mg/m3 (result without PPE

efficiency). The exposure result considering PPE efficiency 95% is 1.10 mg/m3.



Justification of Riskofderm inputs (see details in appendix 4): in Riskofderm model there is no

specific activity covering maintenance operations. From the 6 existing activity (filling-mixing-

loading, wiping, dispersion with hand tool, spraying, immersion, mechanical treatment), “filling-

mixing-loading” is the more relevant for maintenance purpose. Also “More than rare contact” and

“more than light contact” have been chosen because the operator is in direct contact with the inside

part of the equipment. The input “significant amounts of aerosols or splashes” also chosen. As the

equipment is flushed before any dismantlement or handling, we can consider a use rate (“product

handled per min”) of 0.05 l/min of EDC as relevant (covering the potential but not expected residual

EDC).

Duration used in Riskofderm: as formerly described, the full equipment is purged and flushed prior

maintenance campaign. 2 equipment are opened per shift during maintenance operation. Due to the

vapour pressure of EDC, dermal exposure could not exceed 2min per opened equipment (estimated

time for EDC to evaporate) in a worst case situation where release of EDC is present in the equipment

after purge and flush (not expected). Considering that only part of the equipment is in contact with

EDC and could lead to dermal exposure, a maximum of 4 minutes of dermal exposure per day is

considered for the assessment of WCS5 dermal exposure as a worst case duration (2min / equipment -

2 equipment opened per day max).

The 90th percentile (see justification in chapter 9.0) result is 5.70 E-2 mg/kg/d (using PPE 95%

efficiency).


Route of

exposure and

type of effects



exposure)

Correction

factor for

frequency


Inhalation,

systemic, long-

term

1.10 mg/m3 **

(tier 2 ART model, 90th percentile)

Frequency: 0.022*

Excess cancer risk:

1.45 E-5

Dermal,

systemic, long-

term

5.70 E-2 mg/kg/d **


Frequency: 0.022*

Excess cancer risk:

2.63 E-6

Combined routes,

systemic, long-

term

Excess cancer risk:

1.71 E-5

* Frequency: activity takes place 21 days every 4 years; correction factor = 0.022

** PPE used during the full task then 95% efficiency for inhalation and 95% for dermal have been used to

recalculate exposure (see justification chapter 9.0.9.2)


EC number:

203-458-1


107-06-2



The derived excess cancer risks for systemic, long term effects due to inhalation and dermal contact are

considered to be the lowest achievable risks, following the minimisation principle described in conditions of use

and risk management measures of this contributing scenario.

EC number:

203-458-1


107-06-2


9.1.7. Worker contributing scenario 6: Laboratory quality control (PROC 15).





• The EDC sampled (see WCS2) is analysed for quality control purpose at the service laboratory. This

operation is done every day (1 sample), duration <20 mins. All handling EDC samples are done under fume

cupboard. This equipment is certified and controlled each year.


• Local exhaust ventilation: Yes- All handling EDC samples are done under fume cupboard. This equipment is

certified and controlled each year.


• Dermal Protection: Yes (chemically resistant gloves KCl/ nitrile conforming to EN374 with specific activity

training) (Dermal: 95%) – see material and justification in chapter 9.0.9.2

• Respiratory Protection: No


• Place of use: Indoor – good general ventilation

•Trained and authorized person: General training on risks for chemical are given each years for all operators.

Specific trainings on chemical risk handling are given regularly to all laboratory operators handling EDC. All

tasks involving EDC handling are done by competent and authorized operators.


The WCS6 is covering a specific operation of laboratory quality control. This operation is done once a

day (1 sample each 24 h, < 250 ml). The complete duration is less than 20 minutes. Since 2015, the

number of analysed parameters in the laboratory has been changed. The analysis of turbidity is no

longer carried out which brings the laboratory task involving EDC to less than 20 minutes instead of

several hours before 2015. WCS6 is done by laboratory operators (38 employees in total, only 1

operator involved during a WCS6 operation).

Laboratory operators from WCS6 are not the same operators working in WCS1, WCS2, WCS3,

WCS4 and WCS5.


During the 2014 and 2015 campaign, 6 measures have been done during the specific laboratory QC

task by an external certified laboratory, SOCOTEC Industries (see details in appendix 2). The 90th

percentile result is 0.53 mg/m3 (recalculate on TWA 8h) (no RPE used during the task).



Justification of Riskofderm inputs (see details in appendix 4): the most relevant Riskofderm existing

activity to cover laboratory activity is “filling, mixing or loading”. “Rare contact” has been chosen as

the operator is not in direct contact with the substance (flask handling). “more than light contact” have

been chosen to cover the potential splashes during this operation (worst case). But as the operation is

done in laboratory, the input “significant amounts of aerosols or splashes” has not been chosen (no).

The use rate is 0.1 l/min which is representative of laboratory operation. The duration is 20 minutes.

The 90th percentile result is 0.05 mg/kg/d (using PPE 95% efficiency).

EC number:

203-458-1


107-06-2



Route of

exposure and

type of effects



exposure)

Correction

factor for

frequency


Inhalation,

systemic, long-

term

0.53 mg/m3 **

(measures data, 90th percentile)

Frequency*: 1 Excess cancer risk:

3.18 E-4

Dermal,

systemic, long-

term

0.05 mg/kg/d ***


Frequency*: 1 Excess cancer risk:

1.05 E-4

Combined routes,

systemic, long-

term

Excess cancer risk:

4.23 E-4

* Frequency: activity takes place on daily basis; correction factor = 1.

** no RPE used during the task

*** PPE 95% for dermal have been used to recalculate exposure (see justification chapter 9.0.2.2)






EC number:

203-458-1


107-06-2


10. RISK CHARACTERISATION RELATED TO

COMBINED EXPOSURE.

10.1. Human health

10.1.1. Workers WCS1 and WCS2.

As described in chapter 9, there is combined exposure resulting from worker activities from WCS1

“production process” and WCS2 “EDC sampling for QC” (same operators).

Route of exposure and type of effects Risk characterisation

Inhalation, systemic, long-term for WCS1 Excess cancer risk for WCS1:

2.22 E-4

Dermal, systemic, long-term for WCS1 Excess cancer risk for WCS1:

-

Combined routes, systemic, long-term for WCS1 Excess cancer risk for WCS1:

2.22 E-4

Inhalation, systemic, long-term for WCS2

Excess cancer risk for WCS2:

2.18 E-5

Dermal, systemic, long-term for WCS2 Excess cancer risk for WCS2:

3.15 E-6


2.50 E-5

Combined routes, systemic, long-term for

WCS1 and WCS2

Excess cancer risk for WCS1 and WCS2:

2.47 E-4

EC number:

203-458-1


107-06-2


10.1.2. Workers WCS4 and WCS5.

As described in chapter 9, there is combined exposure resulting from worker activities from WCS4

“non-routine maintenance and cleaning” and WCS5 “general maintenance and cleaning” (same

maintenance operators).

Route of exposure and type of effects Risk characterisation


5.10 E-5 Dermal, systemic, long-term for WCS4 Excess cancer risk for WCS4:

4.26 E-5


9.36 E-5


1.45 E-5 Dermal, systemic, long-term for WCS5 Excess cancer risk for WCS5:

2.63 E-6


1.71 E-5

Combined routes, systemic, long-term for

WCS4 and WCS5

Excess cancer risk for WCS4 and WCS5:

1.11 E-4

10.1.3. Consumer.

Not applicable, as there is no consumer related use for the substance.

EC number:

203-458-1


107-06-2


10.2. Environment (combined for all emission sources)

Environment

Not relevant.

Man via environment

The risk assessment of man via the environment is mainly based on the potential exposure of the

general population via air as well as indirect oral exposure through consumption of drinking water

and/or various crops/food potentially contaminated with EDC following its industrial emission at

Grupa LOTOS industrial facility. Local and regional risk assessment were conducted so to ensure

all potential emissions are taken into account. (See table below).

Regional exposure to man via environment

Route Regional exposure Risk characterisation

Inhalation 2.59 10-08 mg/m3 Excess of risk 8.94 10-11

Combined routes 7.56 10-09 mg/kg/d Excess of risk 9.07 10-11