committee for risk assessment (rac) committee for socio

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Committee for Risk Assessment (RAC)

Committee for Socio-economic Analysis (SEAC)

Opinion

on an Application for Authorisation for

Use of 1,2-dichloroethane: 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

ECHA/RAC/SEAC: AFA-O-0000006548-64-02/F

Consolidated version

Date: 17/01/2017

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu

Consolidated version of the

Opinion of the Committee for Risk Assessment

and Opinion of the Committee for Socio-economic Analysis

on an Application for Authorisation

Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (the REACH Regulation), and in particular Chapter 2 of Title VII thereof, the Committee for Risk Assessment (RAC) and the Committee for Socio-economic Analysis (SEAC) have adopted their opinions in accordance with Article 64(4)(a) and (b) respectively of the REACH Regulation with regard to an application for authorisation for:

Chemical name(s): 1,2-dichloroethane EC No.: 203-458-1 CAS No.: 107-06-2

for the following use: 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

Intrinsic property referred to in Annex XIV: Article 57 (a) of the REACH Regulation

Applicant:

GRUPA LOTOS S.A.

Reference number: 11-2120115210-81-0000

Rapporteur, appointed by the RAC: Elżbieta JANKOWSKA Co-rapporteur, appointed by the RAC: Sonja KAPELARI Rapporteur, appointed by the SEAC: Gary DOUGHERTY Co-rapporteur, appointed by the SEAC: Maria NORING This document compiles the opinions adopted by RAC and SEAC.

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PROCESS FOR ADOPTION OF THE OPINIONS On 19/02/2016 GRUPA LOTOS S.A. submitted an application for authorisation including information as stipulated in Articles 62(4) and 62(5) of the REACH Regulation. On 02/05/2016 ECHA received the required fee in accordance with Fee Regulation (EC) No 340/2008. The broad information on uses of the application was made publicly available at http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/applications-for-authorisation on 27/04/2016. Interested parties were invited to submit comments and contributions by 22/06/2016. No comments were received from interested parties during the public consultation in accordance with Article 64(2)). The draft opinions of RAC and SEAC take into account the responses of the applicant to the requests that the SEAC made according to Article 64(3) on additional information on possible alternative substances or technologies. The draft opinions of RAC and SEAC were sent to the applicant on 09/01/2017. On 17/01/2017 the applicant informed ECHA that they did not wish to comment on the opinions. The draft opinions of RAC and SEAC were therefore considered as final on 17/01/2017. ADOPTION OF THE OPINION OF RAC The draft opinion of RAC The draft opinion of RAC, which assesses the risk to human health arising from the use of the substance – including the appropriateness and effectiveness of the risk management measures as described in the application and, if relevant, an assessment of the risks arising from possible alternatives – was reached in accordance with Article 64(4)(a) of the REACH Regulation on 16/09/2016. The draft opinion of RAC was agreed by consensus. The opinion of RAC Based on the aforementioned draft opinion and in the absence of comments from the applicant, the opinion of RAC was adopted as final on 17/01/2017. ADOPTION OF THE OPINION OF SEAC The draft opinion of SEAC The draft opinion of SEAC, which assesses the socio-economic factors and the availability, suitability and technical and economic feasibility of alternatives associated with the use of the substance as described in the application was reached in accordance with Article 64(4)(b) of the REACH Regulation on 15/09/2016. The draft opinion of SEAC was agreed by consensus. The opinion of SEAC Based on the aforementioned draft opinion and in the absence of comments from the applicant, the opinion of SEAC was adopted as final on 17/01/2017.

http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/applications-for-authorisation

http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/applications-for-authorisation

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THE OPINION OF RAC The application included the necessary information specified in Article 62 of the REACH Regulation that is relevant to the Committee’s remit. RAC has formulated its opinion on: the risks arising from the use applied for, the appropriateness and effectiveness of the risk management measures described, the assessment of the risks related to the alternatives as documented in the application, the information submitted by interested third parties, as well as other available information. RAC confirmed that it is not possible to determine a DNEL for the carcinogenic properties of the substance in accordance with Annex I of the REACH Regulation.

RAC confirmed that the operational conditions and risk management measures described in the application limit the risk, provided that they are adhered to along with the suggested conditions and monitoring arrangements. THE OPINION OF SEAC The application included the necessary information specified in Article 62 of the REACH Regulation that is relevant to the Committee’s remit. SEAC has formulated its opinion on: the socio-economic factors and the availability, suitability and technical and economic feasibility of alternatives associated with the use of the substance as documented in the application, the information submitted by interested third parties, as well as other available information. SEAC took note of RAC’s confirmation that it is not possible to determine a DNEL for the carcinogenic properties of the substance in accordance with Annex I of the REACH Regulation. SEAC confirmed that there appear not to be suitable alternatives in terms of their technical and economic feasibility for the applicant. SEAC considered that the applicant's assessment of: (a) the potential socioeconomic benefits of the use, (b) the potential adverse effects to human health of the use and (c) the comparison of the two is based on acceptable methodology for socio-economic analysis. Therefore, SEAC did not raise any reservations that would change the validity of the applicant’s conclusion that overall benefits of the use outweigh the risk to human health, whilst taking account of any uncertainties in the assessment, provided that the suggested conditions and monitoring arrangements are adhered to.

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SUGGESTED CONDITIONS AND MONITORING ARRANGEMENTS

Additional conditions and monitoring arrangements for the authorisation:

None.

Conditions and monitoring arrangements for review reports:

a) The applicant has indicated that they have planned additional worker exposure measurements. The applicant shall include the task “regular, scheduled maintenance” as described in WCS 5 as part of these measurements. Measurements shall be undertaken according to standard sampling and analytical methods, where possible. The monitoring results shall be used in the review report to describe exposure of workers.

b) The applicant shall include all sources of release to the air (including fugitive emissions) in the exposure assessment in any authorisation review report submitted.

REVIEW Taking into account the information provided in the application for authorisation prepared by the applicant, the duration of the review period for the use is recommended to be 12 years.

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JUSTIFICATIONS

The justifications for the opinion are as follows:

1. The substance was included in Annex XIV due to the following property/properties:

Carcinogenic (Article 57(a))

Mutagenic (Article 57(b))

Toxic to reproduction (Article 57(c))

Persistent, bioaccumulative and toxic (Article 57(d))

Very persistent and very bioaccumulative (Article 57(e))

Other properties in accordance with Article 57(f):

2. Is the substance a threshold substance?

YES

NO

Justification:

1,2-Dichloroethane (EDC) has a harmonised classification as Carc. 1B with H350 according to Classification, Labelling and Packaging Regulation, (EC) 1272/2008.

Based on studies which show its genotoxic potential, the Risk Assessment Committee (RAC) has concluded that EDC should be considered as a non-threshold carcinogen with respect to risk characterisation (reference to the studies examined are included in the RAC document RAC/33/2015/09 Rev. 1 Final).

3. Hazard assessment. Are appropriate reference values used?

Justification:

RAC has established a reference dose-response relationship for the carcinogenic effect following exposure to EDC (RAC/33/2015/09 Rev. 1 Final). Based on experimental animal data (cited in the RAC document), a potentially increased risk of cancer occurring due to genotoxicity of the substance was noted.

In the absence of epidemiological studies on occupational exposure to EDC that would be useful in identifying any quantitative risk for humans, the dose-response estimations are based on the most relevant, robust study in experimental animals (development of mammary tumours in rats). A linear relationship between the exposure to each unit amount of EDC and the cancer risk was assumed.

The following cancer risk estimates were calculated by RAC and used by the applicant:

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Table 1: Dose-response relationship for carcinogenicity of 1,2-dichloroethane established by RAC (RAC/33/2015/09 Rev. 1 Final)*

Route of exposure Population Cancer risk for 1 unit

Inhalation Workers 6.0 × 10-7 per μg/m3

General population 3.45 × 10-6 per μg/m3

Dermal (for 50% dermal absorption)

Workers 2.1 × 10-6 per μg/kg bw/day

General population 6 × 10-6 per μg/kg bw/day

Oral General population 1.2 × 10-5 per μg/kg bw/day

* Risk calculation refers to 40 years of exposure for workers and lifetime exposure for general population.

In the socio-economic analysis (SEA) the remaining human health risks are evaluated based on the dose-response relationship adopted by RAC.

Are all appropriate and relevant endpoints addressed in the application?

The cancer risk was estimated using the dose-response curve developed by RAC for all relevant routes of exposure and exposed populations.

4. Exposure assessment. To what extent is the exposure from the use described?

Description:

Short description of the use

Grupa LOTOS is a downstream user of 1,2-dichloroethane (EDC), based in Gdańsk, Poland.

The applicant uses a mixture of EDC and dichloromethane (DCM) in a closed loop process to dilute a 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. In the case of de-oiling, slack wax (rather than vacuum distillate) is used as feedstock in the production line and EDC-DCM mixture 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 to occur. This process generates hard paraffin waxes (in two grades) and foot oils.

The applicant explains that the solvent mixture is circulated continuously, it is regenerated by distillation and re-fed into the process (i.e. recycled). The quantity of EDC present in the system is in the range of 100-1,000 tonnes. New quantities of solvent are added to the system when the quantity of the solvent is deemed insufficient. Therefore, while the annual throughput of the solvent through the system is high, the consumption of EDC is much lower, in the 10 to 100 t/a range.

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According to the applicant, the concentration of EDC in the products is well below 0.001% and therefore, workers in downstream life cycle stages or consumers are considered not to be exposed to the substance.

RAC accepts the applicant’s approach not to assess exposure for consumers.

Exposure scenario

The applicant describes one exposure scenario, concerning an industrial use at a single site involving potential exposure of workers as follows:

”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”

According to the applicant, the exposure scenario presented includes all relevant processes and tasks associated with the use of EDC that could result in either environmental or worker exposure. The exposure scenario comprises six worker contributing scenarios (WCS) and one environmental contribution scenario (ECS).

Workers exposure

The tasks performed are described in sufficient detail by the applicant. They are summarised in Table 2.

Table 2: Summary of worker contributing scenarios (WCS), process categories (PROC), risk management measures (RMMs) and operational conditions (OCs)

WCS Brief description

of the tasks

Duration/ frequency of

tasks

Number of workers

RMMs* and OCs

WCS 1

Production process including storage, transfers, recycling, waste transfers

(PROC 2)

Production process (de-waxing and de-oiling), including storage, transfers, recycling, waste transfers.

The tasks done by operators are facility supervision, control from the room panel control, visual control routines on unit.

Duration: 8 h/shift

Frequency: all year (F=1)

15 workers

Closed systems.

Control and emergency systems.

Good general ventilation – indoor.

Outdoor or indoor.

No sampling or other manual tasks.

WCS 2

EDC sampling for quality control

(PROC 8b)

Filling sampling bottle with mixture of solvents (250 ml of 100% EDC per sampling). Sending sample cylinder (hermetically

Duration: 5 min

Frequency: 1 event per 24 h (F=0.33)**

15 workers

The same as for WCS1

Closed loop sampling.

PPE: antistatic workwear, chemically resistant gloves KCl/nitrile.

Outdoor.

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closed) to laboratory.

WCS 3

Receipt of EDC by rail tank

(PROC 8b)

Taking sample from manhole of rail tank and sending to the laboratory.

Connecting/ disconnecting flexibles to rail tank.

Visual control during unloading (far-off road tank).

Duration: 3 h (5 min sampling, 5 min connecting/ disconnecting of flexibles, 170 min unloading)

Frequency: 1 event per 2 years (F=0.0021)**

2 workers

Fixed connection and hose steel connections.

Leak test after establishing the connection.

Purged with nitrogen gas.

Vapour recovery systems (80% effectiveness)***.

PPE: antistatic workwear and TYVEX, chemically resistant gloves KCl 890 / Fluorocaoutchouc, full face mask with absorber A2B2E2K2HgP3.

Outdoor.

WCS 4

Non routine maintenance and cleaning

(PROC 8b)

Small repairs in case of equipment dysfunction (e.g. pump).

The description of the maintenance work and specific risk management measures are described in a permit procedure.

Duration: 15 min

Frequency: 1 event per month (F=0.05)**

6 workers

Good general ventilation – indoor (3 ACH***).

PPE: antistatic workwear and TYVEX, chemically resistant gloves KCl 890 / Fluorocaoutchouc, full face mask with absorber A2B2E2K2HgP3.

Outdoor and indoor.

WCS 5

General maintenance and cleaning

(PROC 8b)


The description of the maintenance work and specific risk management measures are described in a permit procedure.

Duration: 6 h

Frequency: over 3 weeks every 4 years (F=0.022)**

6 workers

The same as for WCS4

Purged with solvent (DCM/EDC) first and with base oil afterwards.

Good general ventilation - indoor (3 ACH***).

PPE: antistatic workwear and TYVEX or TYCHEM , chemically resistant gloves KCl 890 / Fluorocaoutchouc, full face mask with absorber A2B2E2K2HgP3.

Outdoor or indoor.

WCS 6

Laboratory quality control

(PROC 15)

Quality control analysis in laboratory.

All handling EDC samples are done under fume cupboard

Duration: 20 min

Frequency: 1 event per 24 h (F=1)**

1 worker out of 38 laboratory workers

LEV (effectiveness 90%).

Good general ventilation.

PPE: antistatic workwear, chemically resistant gloves KCl/nitrile.

Indoor.

* Tasks are performed by trained and authorised persons (general and specific trainings on chemical risk handling). In addition, the applicant ensures that the workers are aware of an adequate use of PPE. The details of PPE used by workers: chemically resistant gloves KCl / nitrile (minimum layer thickness: 1.2mm, break

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through time 30-60 min, protection against splashes, effectiveness 95%), chemically resistant gloves KCl 890 / Fluorocaoutchouc (minimum layer thickness: <1.0mm, break through time 30 min, effectiveness 95%), full face mask with absorber A2B2E2K2HgP3 (effectiveness 95%), footwear, helmets, Tyvek workwear, eyewear.

** F = frequency correction factor: The calculation of F for WCS 2 it is 1 x 3 / 240 x 24 (one event in 24 hours, 240 days / year, i.e. only one of the 3 shift teams takes a sample); for WCS 3 it is 1 / 480 (one event / 480 days); for WCS 4 it is 12/240 (one event per month); for WCS 5 it is 1 x 21 / 240 x 4 (21 days in 4 years). For WCS 6, as there is no shift-work in the laboratory, no correction factor is needed.

*** Standard value used in the ART 1.5 modelling.

The production process in 1300 unit using EDC (WCS 1) is a continuous one, operating 24/7, all year (only 3 weeks every 4 years of maintenance break). There are five teams working in a 3-shift system, 15 employees in total. Each operator is able to perform any task and workers take turns in the tasks required.

Exposure estimation methodology:

A quantitative exposure assessment was carried out for inhalation and dermal exposure for workers.

For inhalation exposure assessment the applicant used two methods: air monitoring (personal sampling) for WCS 1, WCS 2 and WCS 6 and modelling (ART model – Advanced Reach Tool v.1.5) for WCS 3, WCS 4 and WCS 5.

Dermal exposure was modelled using RISKOFDERM v.2.0. In the CSR, modelled data were provided for WCS 2, WCS 3, WCS 4, WCS 5 and WCS 6, where, according to the applicant, there is potential for dermal exposure. There is no potential for dermal exposure in WCS 1.

Inhalation exposure:

According to the applicant, specific measurement campaigns were performed in October 2014 and October 2015 to assess inhalation exposure. The methodology used for these measurement campaigns is based on: CSN EN 689, BOHS NvvA sampling strategy guidance (2011), ECHA guidance R14 (2012) and ISO 16200 (NIOSH 1003) with a limit of quantification of 1 μg/sampler.

The applicant based the exposure assessment on the 90th percentile of 10 personal samples (six measurements conducted in 2014 and four conducted in 2015) for WCS 1 and on six measurements (three conducted in 2014 and three in 2015) for both WCS 2 and WCS 6.

For WCS 3, modelling data were provided for the three different activities performed: a) sampling of EDC on rail tank – duration 5 min; b) connection/disconnection flexibles – duration 5 min; c) road tank unloading – duration 170 min. Each activity was modelled separately. The resulting exposure concentration, corrected for RPE with 95% effectiveness for sampling and connecting/disconnecting flexibles, was summed up to cover all three tasks for WCS 3.

Regarding inhalation exposure for WCS 4, the applicant states that the duration for the activity is limited to 15 min. For the rest of the shift no exposure is considered. According to the applicant, the relevant activity for this contributing scenario in ART is ‘handling of contaminated objects with surface 1-3 m2 with a contamination of 10-90% of the surface’.

For general maintenance and cleaning operations (WCS 5), before equipment dismantling, the equipment is purged with solvent (DCM/EDC) until all wax is washed off. Then the

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equipment is purged with base oil in order to bind and flush out solvent completely. According to the applicant, the relevant activity in ART is described as ‘handling of contaminated objects with surface > 3 m2 with a contamination of 10-90% of the surface’. The applicant states that maintenance operations take between one and six hours. However, exposure calculation has been carried out for a worst-case scenario, considering a task duration of six hours.

RAC notes that the applicant used for both WCS 4 and WCS 5 an air exchange rate per hour of three in the model even though all equipment is located outside, except rotary drum filters and gas compressors.

For risk characterisation, the applicant used the 90th percentile not only for the exposure concentrations obtained by personal monitoring (WCS 1, WCS 2, WCS 6) but also for the values calculated by ART model (WCS 3, WCS 4 and WCS 5).

Table 3: Inhalation exposure

Worker Contributing

Scenario

Method of assessment

Exposure value, 8h

TWA (mg/m3)

Exposure value

(mg/m3) corrected for

RPE*

Exposure value

(mg/m3) corrected for

RPE* and frequency

WCS 1 (PROC 2)


Measured data:**

10 personal measurements

0.37 0.37 (no RPE used)

0.37

WCS 2 (PROC 8b)

EDC sampling for QC

Measured data:** 6 personal measurements

0.11 0.11 (no RPE used) 0.0363

WCS 3 (PROC 8b)


Modelled data: ART 1.5

0.66*** 0.66*** 0.0014

WCS 4 (PROC 8b)



33 1.7 0.085

WCS 5 (PROC 8b)



22 1.1 0.0242

WCS 6 (PROC 15)


Measured data:** 6 personal measurements

0.53 0.53 (no RPE used) 0.53

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* RPE is considered with 95% effectiveness.

** Measured data are presented as the 90th percentile of an 8 h TWA.

*** WCS3 consists in three activities: activity 1 (sampling of EDC on rail tank; 5 minutes): 78 mg/m³ without RPE, 3.9 mg/m³ with RPE; activity 2 (connection/disconnection flexibles; 5 minutes): 26 mg/m³ without RPE, 1.3 mg/m³ with RPE; activity 3 (road tank unloaded; 170 minutes): 1.7 mg/m³ without RPE (no RPE is used for activity 3).

Dermal exposure:

No dermal exposure is expected during the production process (WCS 1). The tasks performed by operators are: facility supervision, control from the room panel control, visual control routines on unit. Therefore dermal exposure for WCS 1 was not assessed by the applicant.

The 2 tier model RISKOFDERM v.2.0 was used to estimate exposure for all other WCSs, i.e. WCS 2, WCS 3, WCS 4, WCS 5 and WCS 6. The input parameters are provided in the annex to the CSR. For each contributing scenario, the same density value (1.244 g/cm3 at 20°C) was used as input – also in the case of maintenance activity, where EDC is diluted with flushed oil, factor of 1.244 g/cm3 was kept as worst case value (instead of value below 1 for oil). Body weight of 70 kg was used. The potential dermal exposure time related for each task was used for duration in RISKOFDERM. For all WCSs for which gloves are used (WCS 2 to WCS6), the applicant has considered their effectiveness to be 95%.

For risk characterisation the applicant used the 90th percentile values calculated with RISKOFDERM for WCS 2, WCS 3, WCS 4 WCS 5 and WCS 6.

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Table 4: Dermal exposure

Worker Contributing Scenario

Method of assessment

Exposure estimate (mg/kg bw/day)

Exposure estimates corrected for PPE* (mg/kg bw) per worker

Exposure estimates corrected for PPE* and frequency (mg/kg bw) per worker

WCS 1 (PROC 2)


Qualitative assessment 0 0 0

WCS 2 (PROC 8b)

EDC sampling for QC

Modelled data: RISKOFDERM v.2

0.0906 0.00453 0.0015

WCS 3 (PROC 8b)**



- 0.15 0.0003

WCS 4 (PROC 8b)



8.1 0.405 0.02025

WCS 5 (PROC 8b)



1.14 0.057 0.00125

WCS 6 (PROC 15)



1 0.05 0.05

* PPE is considered with 95% effectiveness.

** There is no dermal exposure during activity 3 (road tank unloading) but during activity 1 (sampling of EDC on rail tank: 2.8 mg/kg bw/d without PPE, 0.14 mg/kg bw/d with PPE) and activity 2 (connection/disconnection flexibles: 0.16 mg/kg bw/d without PPE, 0.008 mg/kg bw/d with PPE).

Combined exposure:

The applicant considered combined exposure due to the fact that some tasks described in separate worker contributing scenarios are performed by the same workers. Combined exposure is calculated for production process operators (WCS 1) who are also involved in the EDC sampling for quality control (WCS 2) and for maintenance operators performing non-routine maintenance and cleaning (WCS 4) and general maintenance and cleaning (WCS 5). Regarding production process and sampling, higher exposure values were obtained for production process (WCS 1) than for EDC sampling (WCS 2). Regarding maintenance operations, higher exposure values were estimated for non-routine (WCS 4)

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than general (WCS 5) maintenance and cleaning. Tasks of WCS 3 and WCS 6 are performed by workers which are not involved in tasks of other WCSs.

Uncertainties related to the exposure assessment for workers:

The inhalation exposure assessment provided by the applicant is based on results of measurements and modelled data. There are some minor uncertainties as to the exposure estimation methodology for workers because measured exposure levels are available only for WCS 1, WCS 2 and WCS 6 but not for WCS 3, WCS 4 and WCS 5. The applicant explained that as the WCS 2, WCS 3 and WCS 5 are performed with a relatively low frequency, it was difficult to perform measurements. Furthermore the applicant argued that general maintenance and cleaning (WCS 5) is only performed after that the equipment and pipes are thoroughly flushed and purged, which considerably reduces the residual quantity of solvent present in such equipment. However, although a higher tier modelling tool has been used to reduce uncertainty, measurement programmes could have been undertaken, especially during planned, routine maintenance. Taking into consideration the nature of the maintenance tasks, including workers being in the areas of the plant not designated as workstations, where ventilation may be impaired, and the fact that input parameters for modelling do not reflect the exposure situations accurately, RAC is of the opinion that use of measured data would significantly increase the reliability of the exposure assessment for regular maintenance tasks described in WCS 5. The need for measured exposure values is strengthened by the fact that maintenance seem to be the highest exposure tasks, the only ones for which RPE is needed to minimise the exposure.

Regarding the modelled data, RAC considers that the input data are in general reliable but notes that for maintenance operations, good ventilation with an air exchange rate of three was considered; this might be an overestimate for some tasks performed in a poorly ventilated plant area.

The dermal exposure assessment provided by the applicant is based on the modelling tool RISKOFDERM v.2.0. The applicant argues that the model was developed for substances and situations with significant dermal exposure, it does not cover the relevant activities related to this application and it was neither made for highly volatile substances like EDC nor datasets including such substances are included in the empirical database used to establish the model. Therefore, the assessment results may present some uncertainties. However, since the duration of the potential dermal exposure related to the task was used as an input parameter - which can be considered as a refined approach - RAC considers that the method used does not imply significant relevant uncertainties. In addition, the use of alternative modelling tool - ECETOC TRA - is also linked to significant uncertainties.

Environmental releases / Indirect exposure to humans via the environment

The applicant considered that “Industrial use of processing aids in processes and products, not becoming part of articles” (ERC 4) is the most appropriate environmental contributing scenario.

Estimation of releases

Releases to water

Wastewaters containing EDC arise from the de-waxing unit from two sources:

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− process water, − surface water run-off (paved areas of production area), termed “oiled rainwater”.

Wastewaters are initially treated within the de-waxing unit using a stripper column and then sent to the on-site wastewater treatment plant, which comprises chemical (flocculation) and biological treatment steps. Treated wastewater is then discharged to the Martwa Wisla river (referred to as discharge point 12).

Data on the concentration of EDC in wastewater during various stages of treatment was obtained for the Grupa Lotos site over the period 2010 – 2012 as part of PhD thesis research conducted by a student from the Gdańsk University of Technology, resulting in a series of publications1. Samples for VOC analysis, including EDC, were taken every two weeks with an analytical limit of detection (LoD) of 0.33 μg/L and a limit of quantification (LoQ) of 1 μg/L (analytical method DAI-GC-ECD). Whilst EDC was regularly detected in wastewater during the various treatment stages it was not detected in samples of final effluent after biological treatment (sampled from discharge point 12) on any occasion.

Since January 2015, the applicant reports that a new programme of regular monitoring (monthly flow proportional sampling) of the EDC concentration in treated effluent has been conducted at sample point 12 using an international standardised analytical method (PN-EN ISO 10301:2002) with an LoD of 1 μg/L. All analyses using this method report EDC concentrations below the LoD of 1 μg/L. In addition, samples taken in the receiving water (upstream and downstream of the discharge point - sample points 12a) and 12b) as part of this programme also result in reported concentrations of EDC below the LoD of 1 μg/L.

Based on the observation that EDC is consistently not detected in treated wastewater, the applicant proposed that releases to water were based on a concentration of EDC in treated wastewater of 0.33 μg/L, which is equivalent to the LoD reported by the PhD research (Tobiszewski and Namieśnik, 2011). Combined with the discharge rate of the on-site wastewater treatment plant (13,380 m3/day, based on 2014 data) the applicant calculates a release of EDC to water of 9.27 g/day.

Releases to air

The applicant states that all equipment in the de-waxing and de-oiling unit is connected to a general vent-gas balance vessel to ensure regular pressure in the unit and to avoid direct releases of EDC to air. In the absence of information on releases from relevant point sources, the applicant estimated potential releases of EDC into air from the de-waxing unit by measuring the ambient concentration of EDC at three residential locations surrounding the Grupa Lotos site in 2015. Sampling was for EDC in both gaseous (Radiello passive tubes and GC/MS EDC analysis) and atmospheric deposit form (NF X43-014 - Bergerhoff gauge samples HS/GC/MS EDC analyses following NF ISO 11423-1 and NF EN ISO 10301). The sampling locations were chosen taking into account the prevailing wind direction i.e. mainly East and South and West of the production plant. RAC notes that these measurements will take into account any contribution to overall emissions from fugitive emissions, which according to the applicant’s simple mass balance calculations, could be very significant e.g. >>1 tonne/year (precise estimated figure claimed by the applicant as

1 Tobiszewski M, Tsakovski S, Simeonov V, Namieśnik J. Chlorinated solvents in a petrochemical wastewater treatment plant: An assessment of their removal using self-organising maps. Chemosphere 87 (2012) 962–968; Tobiszewski M, Tsakovski S, Simeonov V, Namieśnik J. Surface water quality assessment by the use of combination of multivariate statistical classification and expert information. Chemosphere 80 (2010) 740–746; Tobiszewski M, Namieśnik J. Determination of chlorinated solvents in industrial water and wastewater by DAI–GC–ECD. 2011. Analytical and Bioanalytical Chemistry (2011) 399:3565–3572; Tobiszewski M, Namieśnik J. Distribution of volatile organohalogen compounds in petrochemical plant water streams. 2012. Chemistry and Ecology (2012) 29(2):1-7.

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confidential).

EDC concentrations in air at each of the measurement points were all below the LoD (0.43 μg/m3). Similarly, the results of the deposition analyses at each of the three sites were all below their respective LoDs (0.966 μg/m2/day, 1.066 μg/m2/day and 0.733 μg/m2/day). The applicant based their assessment of indirect exposure to the general population via inhalation (PEClocal, air) on the results of the atmospheric monitoring (i.e. 0.43 μg/m3). The applicant also used the results of the measurements in air to back-calculate an atmospheric release factor for the use of EDC at the Grupa Lotos site.

RAC notes that the method used by the applicant to back-calculate the release factor may not be reliable as it relies on the empirical relationship used in the EUSES model to estimate the ambient concentration in air 100 m from a point source from the amounts released. As each of the EDC sample points were approximately 500 m from the de-waxing unit, back-calculating using the same relationship is likely to underestimate the release factor. On RAC´s request (during the trialogue), the applicant provided further information to support their approach. Whilst RAC recognises the efforts of the applicant to provide further justification for their proposed methodology, RAC does not consider that the additional modelling information provided supports the applicant’s proposed approach. On the contrary, the additional modelling clearly demonstrates that concentrations 100 m from the site will be markedly different from those at 500 m. As such, RAC does not consider that the release factor provided for the atmospheric compartment is reliable.

Nevertheless, RAC considers that the PEClocal, air derived by the applicant from atmospheric monitoring data is reliable and appropriate for assessment of indirect exposure to humans via the environment, not least because it integrates releases from the de-waxing unit from both point and fugitive sources.

Table 5: Releases to the environment

Release Release rate Justification

Water Emission in water equivalent to 9.27 g/day

The above release factor is calculated using EUSES 2.1.2 leading to a concentration of EDC in the STP effluents of 0.33 μg/L Discharge rate: 13,380 m3/day (2014)

Air Equivalent emission in the air phase: 1.55 kg/day

The release is based on measured concentration of 0.43 μg/m3 i.e. the LoD of the measured concentration in the air phase.

Soil 0 No release of contaminated sludge onto agricultural soils.

Exposure estimation methodology:

The applicant provided an assessment of indirect exposure to humans via the environment at both local and regional scales based on EUSES modelling (version 2.1.2).

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Table 6: Summary of indirect exposure to humans via the environment

Uncertainties related to the assessment of exposure to humans via the environment:

The applicant’s estimate of release to water was based on an assumed concentration in wastewater of 0.33 µg/L. This value was the LoD of the analytical method used in monitoring conducted as part of PhD research undertaken between 2010 – 2012 (Tobiszewski and Namieśnik 20112) and the observation at all EDC analyses in final effluent were below this concentration. Recent measurements, conducted according to an internationally standardised method that had a moderately greater LoD of 1 µg/L, also consistently report EDC concentrations in wastewater below the LoD. RAC would have preferred that the applicant’s assessment was based on the most recent (standardised) data available, rather than the historical (unstandardised) data. However, RAC notes that use of ½ of the LoD of the recent data (which is a common method to account for data reported below a reporting limit in environmental monitoring datasets) would have resulted in an EDC concentration of 0.5 µg/L, rather than the value of 0.33 µg/L used by the applicant, which is not markedly different. RAC therefore considers the uncertainties related to releases to wastewater to be low and that the applicant’s assessment is acceptable for risk and impact assessment.

The applicant’s estimate of indirect exposure to the general population via the atmosphere was based on measured data that appear to be appropriate and reliable. The measured dataset for atmospheric emissions incorporates potential fugitive emissions. RAC therefore considers that there are no significant uncertainties in the atmospheric exposure estimate (PEClocal, air) used in the applicant’s assessment of indirect exposure to human via the environment. However, RAC notes that the applicant’s approach to calculate the atmospheric release factor for the use is uncertain and, given the information provided by the applicant in their mass balance on the potential scale of fugitive emissions, the value of 1.55 kg/day reported could be a significant underestimate.

RAC acknowledges that assessment of indirect exposure to humans via the environment using default assumptions via EUSES is in general conservative, particularly at the local scale and could lead to an overestimation of risk (and number of statistical cancer cases). However, RAC notes that the use of measured data to estimate PEClocal, air will reduce these uncertainties.

Protection target and units

Exposure estimate, EUSES, local scale

Exposure estimate, EUSES, regional scale

General population – Inhalation (mg/m3)

3.97 × 10-4 2.59 × 10-8

General population – Oral (mg/kg bw/day)

2.50 × 10-6 1.08 × 10-10

2 Tobiszewski M., Namieśnik J. (2011); Determination of chlorinated solvents in industrial water and wastewater by DAI-GC-ECD; Anal. Bioanal. Chem 399: 3565- 3572.

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Conclusion

RAC considers that for both workers exposure and human exposure via the environment:

− The description of use provided allows conclusions related to exposure situations to be drawn.

− The methodology used and the information provided, related to exposure resulting from the use applied for, is considered to be sufficient to use in a risk assessment and in the risk characterisation.

− Concerning workers’ exposure via inhalation, the applicant provided measured data for three of the six WCSs. There are no measurements for maintenance activities and rail tank unloading, leading to some relatively minor uncertainties, applicable especially to the maintenance activities.

− The releases to water are well characterised and uncertainties are considered to be minor.

− The applicant’s estimate of PEClocal, air, derived from monitoring data, is considered to be reliable. However, derivation of the release factor is uncertain and, based on the applicant’s mass balance, could have resulted in a significant underestimation of fugitive losses from the site.

− Overall, the uncertainties identified are considered to be relatively minor and do not invalidate the applicants’ exposure assessment.

5. If considered a threshold substance, has adequate control been demonstrated?

YES

NO

NOT RELEVANT, NON THRESHOLD SUBSTANCE

Justification:

Non-threshold substance.

6. If adequate control is not demonstrated, are the operational conditions and risk management measures described in the application appropriate and effective in limiting the risk?

YES

NO

Justification:

Evaluation of the risk management measures

Regarding the RMMs in place, RAC concludes that the production process is carried out in a closed system which minimises the potential of exposure to workers and the environment. For those activities where the applicant identifies potential for exposure, a high level of occupational health and safety practices are claimed to be in place. In addition, the applicant implemented management systems: health and safety (PN-N-

18

18001) environmental protection (PN-EN ISO 14001) and quality assurance (PN-EN ISO 9001).

The RMMs applied by the applicant include the following:

− All equipment and processes from production units involving EDC are under closed systems and are equipped with control systems.

− Around the buffer vessels for storage of EDC a protection wall against overflow is provided, in case of leakage. All liquid transfer operations follow detailed written procedures to minimise the risks of accidental leakage.

− For the purpose of absorbing potential solvent vapours from the filter seals, a so-called ‘ECO System’ is installed in the plant. All equipment is located outside the building except the rotary drum filters and gas compressors. All equipment of the 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).

− Before any equipment is dismantled for general maintenance, the equipment is purged with solvent (DCM/EDC) until all wax is washed off. In case of equipment dysfunction or equipment change during non-routine maintenance, an operator from the plant unit is in charge to connect secondary equipment (e.g. pump) when relevant.

− Work is performed under written permits according to safety procedure developed on the basis of risk assessment on work positions.

− General training on risks related to handling of chemicals are given each year for all operators, including specific trainings on risk resulting from handling of EDC. All tasks involving potential of exposure to EDC are done by competent and authorised operators.

− PPE is proposed and validated. It is available in the storage room. The availability is controlled by chief operator. Audits are implemented to ensure appropriate handling and use of PPE.

RAC considers that the implemented RMMs and OCs described in the application are appropriate and effective in limiting the risk to workers and the general population, provided that they are adhered to.

Risk characterisation

The applicant has estimated cancer risk according to the RAC reference dose-response relationship for carcinogenicity of 1,2-dichlorethane (RAC/33/2015/09 Rev. 1, Final) due to oral, inhalation and dermal exposure of workers and general population.

Workers

Based on exposure for 40 years of exposure (8h/d, 5d/week), the excess lifetime cancer mortality risk according to the RAC reference dose-response relationship is 6.0 × 10-7 per µg EDC/m3 for the inhalation exposure and 2.1 × 10-6 per µg EDC/kg bw/day for the dermal route of exposure.

The inhalation exposure assessment was based on measured (WCS 1, WCS 2 and WCS 6) and modelled data (WCS 3, WCS 4 and WCS 5). The dermal exposure for WCS 2, WCS 3,

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WCS 4, WCS 5 and WCS 6 was based on modelling whereas the dermal exposure for WCS 1 was estimated by qualitative assessment.

Table 7: Excess risk estimates for 40 years exposure for workers calculated by the applicant

WCS

Dermal route Inhalation route Cancer risk for combined exposure routes

Corrected exposure estimates (mg/kg bw/day)

Excess cancer risk

Corrected exposure estimates (mg/m3)

Excess cancer risk

WCS 1 0 0 0.37 2.22 × 10-4 2.22 × 10-4

WCS 2 0.0015 3.15 × 10-6 0.0363 2.18 × 10-5 2.50 × 10-5

WCS 3 0.0003 6.61 × 10-7 0.0014 8.32 × 10-7 1.49 × 10-6

WCS 4 0.02025 4.26 × 10-5 0.085 5.10 × 10-5 9.36 × 10-5

WCS 5 0.00125 2.63 × 10-6 0.0242 1.45 × 10-5 1.71 × 10-5

WCS 6 Exempted from authorisation

Table 8: Excess risk estimates for combined, shift-long exposure for workers calculated by the applicant

Contributing scenario

Exposed group Excess cancer risk

Excess cancer risk (combined exposure)

WCS 1 Production process and EDC sampling for QC (N=15)

2.22 × 10-4 2.47 × 10-4

WCS 2 2.50 × 10-5

WCS 3 Receipt of EDC by rail tank

(N=2) 1.49 × 10-6 1.49 × 10-6

WCS 4 Non routine and general maintenance and cleaning

(N=6)

9.36 × 10-5 1.11 × 10-4

WCS 5 1.71 × 10-5


RAC agrees with the methodology used by the applicant to calculate the risk and with the results obtained. Based on the available data, RAC is in the opinion that it is reasonable to assume that dermal and inhalation combined exposure to all workers across the site and all activities results in an individual excess risk level for carcinogenicity of 2.47 × 10-

4.

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RAC considers that the applicant´s risk assessment is sufficiently thorough; for half of the WCSs, measured data is available and for the other WCS, a higher tier modelling tool was used to estimate exposure concentration. However, RAC does not agree with the applicant that regular measurements for WCS 5 (general maintenance) are not relevant. RAC proposes that the applicant should perform measurements of exposure during planned maintenance activities, to facilitate the assessment of exposure in authorisation review.

Indirect exposure to humans via the environment

Based on RAC’s reference dose-response relationship for a lifetime exposure (24 h/d, 7 d/week), the excess lifetime cancer mortality risk is 3.45 × 10-6 per µg EDC /m3 for the inhalation exposure and 1.2 × 10-5 per µg EDC/kg bw/d for the oral route. Table 9 below presents the exposure and risks related to exposure to humans via the environment as calculated by the applicant.

Table 9: Excess risk estimates for man via the environment calculated by the applicant

Protection target and units

Local scale Regional scale

Exposure estimate

Excess cancer risk

Exposure Estimate

Excess cancer risk

Man via Environment – Inhalation (mg/m3)

3.97 × 10-4 1.37 × 10-6 2.59 × 10-8 8.94 × 10-11

Man via Environment – Oral (mg/kg bw/day)

2.50 × 10-6 3.00 × 10-8 1.08 × 10-10 1.30 × 10-12

Man via Environment -

Combined

- 1.40 × 10-6 - 9.07 × 10-11

RAC notes that the applicant, on the basis the mass balance calculations presented in the CSR, considers that fugitive emissions may contribute significantly to overall releases of EDC to the environment and has implemented an action plan (continuous improvement programme) to reduce EDC exposure of workers and the general population via the environment.

This plan, described in the CSR, comprises both actions aiming at identification of source of EDC losses from the de-waxing and de-oiling equipment and replacement of equipment, as necessary, to reduce losses. RAC notes that the applicant has already begun replacing equipment such as pipelines and pump seals and has plans to replace existing drum filters up to and beyond the EDC sunset date in 2017. Although RAC notes that the applicant’s approach to estimating indirect exposure already integrates any potential contribution from fugitive emissions, RAC welcomes this action plan.

RAC considers that these estimates of cancer risks are reliable. RAC agrees with the applicant that the major source of indirect exposure and the associated risks to the general population via the environment are emissions of EDC into air. In addition, RAC also agrees

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with the applicant that refinement of the analytical method for air measurements would improve the assessment.

Conclusion

− The RMMs are appropriate and effective in limiting the risks to workers and the general population. However, as releases to air are the major contributor to indirect exposure of the general population, RAC welcomes the applicant’s plan to modernise the de-waxing and the de-oiling equipment. RAC acknowledges also planned upgrading of / changes to the training of workers with regards to occupational safety and health and continuation of the monitoring programme. It is accepted that these activities are intended to facilitate the further improvement of the risk management measures and operational conditions at the site.

− RAC considers that the estimates of excess cancer risk for workers and for indirect exposure to humans via the environment are sufficient to allow a health impact assessment and RAC agrees with the methodology and values presented by the applicant.

− RAC considers that a further refinement regarding exposure estimates for planned maintenance operations would be beneficial, to confirm the level of inhalation exposure to EDC for workers during general maintenance operations. The measurements taken during maintenance would increase the reliability of the exposure assessment for inhalation for workers.

− Overall, while the uncertainties related to the assessment of the risk for workers and humans via the environment are considered to be low, they do exist in relation to the areas mentioned above.

7. Justification of the suitability and availability of alternatives

7.1 To what extent is the technical and economic feasibility of alternatives described and compared with the Annex XIV substance?

Description:

Summary of the analysis of alternatives undertaken by the applicant

In their analysis of alternatives, the applicant considered four alternative processes and a range of alternative solvents or solvent combinations.

Alternative processes:

The alternative processes considered are listed below:

• Cold Settling – a passive process in which the oil-feedstock is stored in barrels or tanks during cold winter months and the wax is allowed to settle.

• Catalytic dewaxing – a process in which the waxes are selectively removed by chemically converting them to smaller hydrocarbons.

• Static crystallisation – a fractional crystallisation technique that employs special equipment to minimise ‘trapping’ of the oils in the wax crystals

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• Wax sweating – a fractional crystallisation process similar to the static crystallisation process that employs different equipment. It is generally less efficient than static crystallisation.

The consideration of these processes by the applicant was somewhat superficial and all were rejected with little detailed justification. However, in the case of cold settling and wax sweating their dismissal would appear to be reasonable. This is because cold settling requires ambient temperatures to be low and is therefore reliant on meteorological factors outside of the applicant’s control. As such it cannot be considered as a long-term solution capable of replacing the use of EDC. The wax sweating process has been superseded by the static crystallisation process, and as this improved process is unsuitable, it can be concluded that the older wax sweating process will also be unsuitable. Therefore its dismissal can also be accepted.

One reason given for dismissing the other two techniques is that neither can be used as replacements for both de-waxing (of the oil feed) and de-oiling (of the waxes recovered). For static crystallisation, the process is applied to a slack wax feedstock and in the applicant’s plant this feedstock is generated using EDC. Thus, introduction of this technique would not eliminate the need to use EDC and its dismissal as a viable option can be accepted.

Whilst the catalytic dewaxing process cannot be used for both processes presented in the application, it is technically possible for de-waxing alone. The applicant rejected this technique on technical grounds as it would remove the wax products from the applicant’s portfolio and reduce the range of Group I oils they produce. Although these factors can be viewed as economic arguments, it remains the case that this technique cannot produce the same range of products as the solvent-based techniques employed by the applicant. In response to questions, the applicant clarified that the process would also require significant investment and whilst the process is capable of producing other product streams (e.g., diesel fuels) these would be insignificant when compared against their current production of fuels by other processes. In addition, the applicant claimed that any Group II oils produced would also require numerous approval certificates (e.g., for Original Equipment Manufacturer approved oil formulations). Although these arguments can be viewed as (partly) economic, if one accepts that the technical requirements are to produce both high-purity waxes and a range of Group I lubricating oils, then catalytic dewaxing can be rejected as technically infeasible.

Alternative solvents:

The applicant has performed a somewhat limited search for alternative solvents. However, solvent dewaxing is a ‘mature’ process (> 80 years old) and one in which it is likely that any possible solvents that would be viable for use industrially would have been previously identified. A literature search would thus most likely identify any previously considered potential alternative solvents. To supplement this literature search, the applicant initiated an in-house research program in 2014 to look at potential drop-in replacement solvents and has previously undertaken work to evaluate some of the alternative solvents included in the open literature (work undertaken in 1993, 1994 and 2009). The literature search identified 17 alternative solvents or solvent combinations and the in-house research identified a further 17 halogenated solvents (the full list of halogenated solvents investigated is confidential).

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The in-house research focussed on identification of solvents with very similar properties to EDC (i.e., halogenated C1-C3 aliphatic hydrocarbons; boiling point > 40 °C). None of the halogenated solvents identified were found to be suitable alternatives as they were: of a similar hazard profile to EDC (e.g., CMR Cat 1A/1B); controlled under the Montreal Protocol; not available in appropriate quantities (unregistered); registered for intermediate uses only; or some combination of these. Given these shortcomings, they were not investigated further.

For the alternative solvents identified through the literature, a range of factors were considered in order to create a shortlist of potentially viable alternatives. These included:

• The physico-chemical properties of the solvents (e.g., water solubility, density, boiling point, cloud point, chemical & thermal stability);

• The properties and quality of the oils and waxes isolated (e.g., oil content in the wax; pour point and viscosity index of the oils, product purity);

• Process compatibility (e.g., number of dilution and filtration stages, operating pressure);

• Evidence of commercial usage; and • Hazardous properties of the solvents.

Table 4.1 in the applicant’s Analysis of Alternatives gives the list of solvents considered. Through the consideration of the factors identified above, most of the solvents could be eliminated as possible alternatives. Entries 4, 8, 9, 10 and 15 involve the use of solvents with CMR properties (benzene or trichloroethylene) and can be dismissed as they would offer no reduction in risk compared to the use of EDC. Entries 5, 6, 7, 11, 13, & 14 are not included in the latest “Best available techniques Reference” (BREF) Document for solvent dewaxing and there is no evidence that they have ever been used commercially. The applicant therefore dismissed these potential alternatives from further assessment. Entries 12, 16 & 17 were included in the previous research work in 1993 and 1994 and were dismissed by the applicant due to the poor quality of the oils and waxes obtained. As propane (entry 1 in Table 4.1) is normally a gas at standard atmospheric pressure and temperature, its use as a de-waxing/de-oiling solvent would require equipment designed to operate at higher pressures. This would require a complete rebuild of the applicant’s de-waxing and de-oiling unit and it was therefore dismissed by them as a viable alternative. After applying all these considerations the applicant identified two options for further analysis: the Methyl ethyl ketone (MEK)/Methyl isobutyl ketone (MIBK) combination and the MEK/Toluene combination. A summary of these conclusions is presented below.

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Table 10: list of solvents/solvent combinations considered by the applicant

# Solvent Reason for exclusion 1 Propane Dismissed – High pressures - extensive rebuild

required 2 Methyl ethyl ketone (MEK) –

Methyl isobutyl ketone (MIBK)

Taken forward for further analysis

3 MEK – Toluene Taken forward for further analysis 4 Acetone-benzene CMR 5 Acetone-propene Old/obsolete (not in BREF) 6 Acetone-DCM Old/obsolete (not in BREF) 7 DCM Old/obsolete (not in BREF) 8 Benzene CMR 9 Benzene-toluene CMR 10 Sulphur dioxide-benzene CMR 11 MEK Old/obsolete (not in BREF) 12 MIBK Tested 1993/1994 - poor quality products with

applicant’s feedstocks 13 Urea, with DCM Old/obsolete (not in BREF) 14 MEK-DCM Old/obsolete (not in BREF) 15 Trichloroethylene CMR 16 Acetone-toluene Tested 1993/1994 - poor quality products with

applicant’s feedstocks 17 MEK-Tert-butyl methyl ether

(MTBE) Tested 1993/1994 - poor quality products with applicant’s feedstocks

In the applicant’s further analysis of the Methyl ethyl ketone (MEK)/Methyl isobutyl ketone (MIBK) combination and the MEK/Toluene combination they present information on the performance of solvents when used to dewax/de-oil their feedstocks. The MEK/MIBK solvent combination failed to produce oils that would meet the required quality standards. The MEK/Toluene combination was able to produce oils that met some of the technical criteria, but failed on others (e.g., viscosity).

Technical feasibility

Alternative technologies:

As described above, none of the alternative technologies can be considered as viable replacements for the use applied for, as none can produce the same range and quality of products.

Alternative solvents:

Neither of the two shortlisted solvent combinations was found to be a suitable alternative for EDC in the use applied for. For the MEK/MIBK solvent combination, the product quality criteria were not met and a theoretical implementation of this technology would require extensive redesign of the applicant’s plant. For the MEK/Toluene combination some of the product quality criteria could be met, but to achieve this - additional processing is required. As the MEK/Toluene combination came closest in performance to the existing process, it was chosen as the basis of the non-use scenario.

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Overall, given the applicant’s product range (including specialty products), the nature of their feedstocks, the design of their plant and the performance of the alternatives identified, there are currently no alternative solvents or techniques that are technically feasible for the applicant.

Economic feasibility

The applicant has found that both shortlisted potential alternative solvent combinations are technically infeasible and, therefore, their economic feasibility does not need to be addressed in detail. However, they did create a non-use scenario based on the theoretical implementation of a MEK-Toluene based process.

Moving to this technology would require a complete redesign of the plant. The estimated costs of this would be in the hundreds of millions of euros.

Overall, none of the potential alternatives are economically feasible as replacements for EDC in the use applied for.

Conclusion

The description and discussion regarding both technical and economic feasibility provided by the applicant are sufficiently detailed and supported to allow for an assessment. SEAC assessed this data and concurs with the conclusions reached, both in terms of the alternative solvents and alternative techniques. The applicant indicated that they will continue to monitor developments regarding alternative solvents or processes.

7.2 Are the alternatives technically and economically feasible before the sunset date?

YES

NO

Justification:

The analysis of alternatives (AoA) undertaken by the applicant demonstrates that there are currently no suitable alternatives to the use of EDC in the de-waxing of petroleum vacuum distillates and de-asphalted oil and de-oiling of slack wax for the production of base oils, paraffinic waxes and a range of specialities. Whilst there are some shortcomings, the AoA was sufficiently extensive and thorough to allow for an assessment of the alternatives. It is supported by relevant experimental investigations and a degree of previous research.

The overall conclusion drawn by the applicant is accepted by SEAC.

Conclusion

Based on its scrutiny of the analysis of alternatives, SEAC concurs with the assessment made by the applicant, which states that no technically and economically feasible alternatives to EDC will be available by the sunset date.

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7.3 To what extent are the risks of alternatives described and compared with the Annex XIV substance?

Description:

Grupa LOTOS described the efforts made to identify alternatives.

A total of 34 potential alternative solvents and four solventless technologies are identified by the applicant. According to the applicant, only two alternatives merit further consideration: the mixture of MEK-MIBK (methyl ethyl ketone - methyl isobutyl ketone) and the mixture of MEK-Toluene. Both mixtures are identified in the relevant Best Available Techniques Referenced document (EIPPCB, 2015) and the latter is a widely used technology.

The applicant described the hazards (see table below) and the risks of all of the three substances included in the alternative mixtures in detail. They provided comprehensive information about the hazards considering several pieces of literature. They also provided a thorough analysis of risks for workers and the environment and compared the risks with the risks related to the use of EDC.

Table 11: Harmonised classification of the assessed alternative substances according to Regulation (EC) No. 1272/2008

Substance Toxicity to humans Remarks

MEK

Flam. Liq. 2, H225 Eye Irrit. 2, H319 STOT SE 3, H336 EUH066

MIBK

Flam. Liq. 2, H225 Eye Irrit. 2, H319 Acute Tox. 4*, H332 STOT SE 3, H336

MIBK is identified by IARC as possibly carcinogenic to humans (Group 2B).

Toluene

Flam. Liq. 2, H225 Asp. Tox. 1, H304 Skin Irrit. 2, H315 STOT SE 3, H336 Repr. 2, H361d*** STOT RE 2*, H373**

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7.4 Would the available information on alternatives appear to suggest that substitution with alternatives would lead to overall reduction of risk?

YES

NO

NOT APPLICABLE

Justification:

Conclusion

The applicant provided a detailed comparison of the risks related to EDC and the components of the two alternatives MEK-MIBK and MEK-Toluene. Based on these quantitative assessments, the alternative solvent mixtures seem to be advantageous with regard to human health effects. Environmental risks are considered to be in the same range for the alternative mixtures compared to EDC. The applicant is aware of the fact that IARC has identified MIBK as a suspect carcinogenic substance with no evidence for genotoxicity. However, according to the applicant, the alternative solvent mixtures MEK-MIBK and MEK-Toluene would reduce overall risk when compared to EDC.

RAC notes that both alternative substance combinations are identified in the relevant Best Available Techniques Referenced document (EIPPCB, 2015) and agrees with the applicant´s assessment.

7.5 If alternatives are suitable (i.e. technically, economically feasible and lead to overall reduction of risk), are they available before the sunset date?

YES

NO

NOT RELEVANT

Justification:

The applicant has not identified a suitable alternative to replace EDC in the current process.

8. For non-threshold substances, or if adequate control was not demonstrated, have the benefits of continued use been adequately demonstrated to exceed the risks of continued use?

YES

NO

NOT RELEVANT, THRESHOLD SUBSTANCE

Justification:

Additional statistical cancer cases estimated by RAC

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The estimated number of additional statistical cancer cases was calculated using the excess risk value presented in section 6 and the estimation of the number of exposed people provided by the applicant. It reflects the expected statistical number of cancer cases for an exposure over the working life of workers and entire life for general population.

Table 12: Estimated additional statistical cancer cases for workers directly exposed (40 years exposure)

Contributing scenario

Exposed group Excess

cancer risk

Estimated statistical cancer cases (dermal and

inhalation exposure)

WCS 1 Production process and EDC sampling for QC

(N=15) 2.47 × 10-4 3.71 × 10-3

WCS 2

WCS 3 Receipt of EDC by rail

tank (N=2) 1.49 × 10-6 2.98 × 10-6

WCS 4 Non routine and general maintenance and cleaning (N=6)

1.11 × 10-4 6.66 × 10-4 WCS 5


Total estimated cancer cases 4.38 × 10-3

Table 13: Estimated additional statistical cancer cases for indirectly exposed workers and general population (lifetime exposure)

Exposure route Scale Number of people

exposed

Estimated statistical cancer

cases

Inhalation and oral Local - inhabitants

50 7.00 × 10-5

Inhalation and oral* Local- workers

700 2.15 × 10-4

Inhalation and oral Regional 3,092,210 2.80 × 10-4

Total estimated cancer cases 5.65 × 10-4

* The inhalation and oral exposure for indirectly exposed workers is adjusted to 8 hours a day and 240 days/year.

The applicant assumed that at the local scale a maximum of 50 inhabitants and ca. 700 workers may be indirectly exposed to EDC whereas at the regional scale 3,092,210

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inhabitants might be exposed indirectly to EDC. The applicant states that the density of the population in Poland is not as high as in Western Europe therefore they did not base their risk assessment on the number of inhabitants (20 million) used by the EUSES software.

RAC agrees with the calculations made by the applicant.

Costs of continued use (HH)

Use scenario

Human health risks were evaluated by the applicant based on the dose-response relationship adopted by RAC for cancer risk linked to EDC exposure. In order to estimate the excess cancer risk per worker over the review period, the applicant has divided the figures by 40, and then multiplied by 20 years – the length of the review period requested. Five different exposure scenarios have been used to calculate the number of excess fatal and non-fatal cancer cases for workers at the two sites. Estimates of total cancer fatality and survival rate were derived by the applicant from the GLOBOCAN 2012 database for Poland (all cancer types were considered, excluding non-melanoma skin cancer). These fatality and survival rates were used to divide the total number of statistical cancer cases into fatal and non-fatal cases. In total 23 workers are expected to be exposed, therefore the number of statistical excess fatal cancer cases is 1.36 × 10-3, while the number of excess statistical non-fatal cancer cases is estimated at 8.23 × 10-4 for an assessment period of 20 years, i.e. 2.19 × 10-3 cases in total over 20 years (requested review period).

The health impact estimates have been monetised, using a value of €5,000,000 to estimate the health impact costs associated with mortality due to cancer, and €396,000 to estimate the health impact associated with non-fatal cancer (costs per case). The applicant applied these values to the estimated numbers of fatal and non-fatal cancer cases, and discounted over 20 years at a rate of 4%.

The applicant has also considered the risk for the general population. A 1,000 metres radius is assumed for the site, where a total of 50 inhabitants potentially exposed. The number of workers exposed via the environment are estimated at 700 and are assumed to be potentially exposed for 8 hours a day and 240 days per year. Regional exposure has been estimated, assuming a total of 3 million inhabitants potentially exposed within 40,000 km2. This figure is lower than the default 20 million in the ECHA guidance; however, its use can be justified as the applicant’s plant is based on the shores of the Baltic Sea and a significant proportion of this area is uninhabited. In addition, the population density in the area is lower than that used for the default figure. The figure represents a realistic population for the regional area. Local residents have been extracted to avoid double-counting. The excess fatal cancer cases for humans exposed via the environment is estimated at 9.4 × 10-5 and the excess non-fatal cancer cases 5.68 × 10-5 over 20 years, i.e. 1.51 × 10-4 statistical cases in total over 20 years.

The same estimates of total cancer fatality and survival rate and assumptions used for workers statistical cancer cases have been used to estimate and monetise the statistical cancer cases for the general population.

In summary, the present value of the human health impact (workers and humans exposed via the environment) for the continued use scenario is €5,190 where the major part is related to worker exposure.

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The approach taken by the applicant is accepted by SEAC to be used for valuation of mortality and morbidity effects. The assessment of health impacts follows the ECHA guidance to health benefits valuation, using the aggregation of the willingness to pay for fatal risk reduction.

Environmental impacts

The applicant has also considered the environmental impacts related to the continued use of EDC. The applicant considers these impacts as insignificant when it comes to surface water and air. The applicant further states that measures and standards at the site adequately manage the environmental risk. Although SEAC has not thoroughly evaluated the statements made by the applicant, SEAC accepted them and notes that these impacts do not affect the conclusion on the benefits-risks assessment.

Non-use scenario

Human health and environmental impacts

The applicant assumes that any risk from EDC to workers, or the general public, at the sites will cease as the EDC-based production will stop in case of a non-authorisation. Effects on workers and the population in the non-EU site in case of a relocation, have not been taken in consideration by the applicant. It is also assumed that any impact on the environment from EDC-releases will cease. The applicant estimates that there will be an increased effects on global warming, due to increased diesel-powered rail transports of imported goods amounting to a discounted value of €3 million for the period 2018-2037. Although SEAC has not thoroughly evaluated the statements made by the applicant, SEAC accepted them and notes that these impacts do not affect the conclusion on the benefits-risks assessment.

In summary, SEAC considers that the approach and assumptions used to derive the health benefits of “non-use” are, in general, clear, transparent and based on standard assessment practices, such that the estimates derived are robust and valid.

Benefits of continued use (cost of non-use scenario)

The applicant has identified four non-use scenarios:

1) Switch to an alternative solvent at the sunset date; 2) Shut the 1300 Unit down. The remaining units in the Gdańsk refinery would

continue operations as normal; 3) Shut the Lube Oil Complex down. The remaining units in the Gdańsk refinery would

continue operations as normal; 4) Shut the entire Gdańsk refinery down.

The applicant considered that the most likely scenario is a combination of the second and third scenarios. This implies that the de-waxing/de-oiling unit is shut down together with a number of other units. Other units would be affected but continue operating as would the plant in general. SEAC considers this to be a realistic non-use scenario.

A present value based on EBITDA (Earnings before interest, taxes, depreciation and amortization) in the order of hundreds of millions of euros (2018–2037) is expected to be lost over the requested review period of 20 years. The use of EBITDA will lead to an overestimation of the lost profits; however, as the risks are low this overestimation is

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unlikely to affect the ratio of the costs to benefits to any great extent. On this basis the applicant was not asked to recalculate the figures.

The applicant was questioned on the degree to which the claimed profits could be maintained over the 20 year review period requested. They provided market-analysis research that demonstrates that whilst the total market for Group I oil is in decline (due principally to a switch away from Group I oils for light automotive use), there remains a demand for Group I oils for heavy-duty vehicles and marine engines. Coupled with the decline in demand is a decrease in global production capacity. This decrease is principally due to the closure of MEK/Toluene units whose output is focused on the lower viscosity Group I oils. The EDC/DCM units are able to produce the higher viscosity oils that remain in demand. Thus, it can be expected that the applicant’s profits could remain fairly stable for some time to come as they gain an increased share of the declining market. To further support the claimed profits they performed a sensitivity analysis in which they see a 5% drop in EBITDA each year from 2018. The recalculated figures for EBITDA remain in the order of hundreds of millions of euros and so do not affect the cost/benefit ratio.

Since the applicant uses a relatively small volume of EDC, the effects on EDC suppliers and suppliers of other raw materials are expected to be limited. Service suppliers will also be affected, but the magnitude has not been assessed by the applicant. Further, the applicant states that there may be effects on consumers, these are not quantified though. Impacts on downstream users have been estimated at hundreds of millions of euros for the whole period, including higher prices and price increases for logistics. The applicant also underlines the additional costs for reformulation and approval costs for customers. These costs have not been quantified. Neither has increased costs due to lost agreements with the applicant been quantified.

The social impacts are assessed in terms of the number of jobs lost because of the closedown3, both at the applying company and at affiliate companies as well as supporting operators. Redundancy payments for workers at the applying firm are estimated at less than €1 million. Redundancy payments are of distributional character and are not further considered by SEAC.

In general, SEAC considers the applicant’s approach to assessing the economic and social impacts to be based on a sound methodological foundation, which correctly identifies those costs estimated from the perspective of the applicant.

The applicant also considers other impacts, such as impacts on upstream suppliers and downstream users. However, since there are uncertainties related to these estimates, and the figures cannot be validated, they are not considered in the analysis by SEAC.

The profit losses assessed above represent impacts on the applicant. SEAC notes, however, that whilst profits expected from the use applied for would be irrecoverably lost, it is likely that the applicant, or another actor, would make use of the production factors in a second-best use. This means that what matters here, are the opportunity costs of not being able to use the substance applied for and it is likely that at least parts of the profit lost to the applicant will be compensated for elsewhere. Thus, SEAC notes that, from a societal point of view, there may be gains to other actors in the market and that some of the losses incurred by the applicant might therefore be distributional in nature. SEAC therefore considers the profit losses to be an overestimate of the net impacts to the society

3 Estimated by the applicant at 159 workers in Lotos companies and 10 external contractors.

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even though still valid for the applicant itself. Nonetheless, SEAC agrees with the applicant’s conclusion that the benefits of continued use outweigh the risks.

In sum, even considering the uncertainties and potential overestimation of Lotos’ profit losses, these will certainly outweigh the health benefits of the “non-use” scenario.

Conclusion

In order to compare the benefits and costs of continued use, the applicant provided discounted monetary figures. Overall, given the relatively small human health impacts associated with the applicant’s use of EDC, the costs of continued use are small, whilst the benefits of continued use are relatively substantial. As such, the benefits of continued use of EDC exceed the risks of continued use. SEAC considers any uncertainties to be minor, such that they would not affect the overall conclusion.

SEAC consider the conclusion that benefits outweigh the risks of continued use to be robust.

9. Do you propose additional conditions or monitoring arrangements

YES

NO

Description for additional conditions and monitoring arrangements for the authorisation:

None.

Description of conditions and monitoring arrangements for review report:

a) The applicant has indicated that they have planned additional worker exposure measurements. The applicant shall include the task “regular, scheduled maintenance” as described in WCS 5 as part of these measurements. Measurements shall be undertaken according to standard sampling and analytical methods, where possible. The monitoring results shall be used in the review report to describe exposure of workers.

b) The applicant shall include all sources of release to the air (including fugitive emissions) in the exposure assessment in any authorisation review report submitted.

Justification:

a) The applicant provided measured data for worker inhalation exposure for three Worker Contributing Scenarios out of six. There is no measured data available for WCS 4 and WCS 5 (small repairs and general maintenance), leading to some uncertainties in the worker exposure assessment that should be addressed in any review report for this use.

b) The applicant’s mass balance calculations indicate that fugitive emissions may contribute significantly to overall releases of EDC to the environment (>> 1 t/a). These data are used to support the implementation of the applicant’s “EDC action plan” to identify and prevent losses of EDC at source. Whilst RAC acknowledges the

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applicant’s ongoing efforts in this regard, and notes that the assessment of indirect exposure was based on measured data that integrates potential fugitive losses, it notes that there is considerable variability in the applicant’s various estimates of fugitive losses of EDC. For example, the estimate from the mass balance (>> 1 t/a) differ markedly from the estimate back-calculated from ambient monitoring data (1.55 kg/day). As such, RAC considers that the applicant should refine their understanding of fugitive losses of EDC from this use and ensure that these are appropriately described in any exposure scenario included in a review report for this use.

10. Proposed review period:

Normal (7 years)

Long (12 years)

Short (…. _years)

Other:

Justification:

In identifying the review period SEAC took note of the following considerations:

RAC’s advice:

RAC does not offer any advice concerning the length of the review period.

Socio economic considerations

The exposure level described results in low human health impact (monetised costs in the order of €5,190 over 20 years). In contrast, the socio-economic benefits of continued use are high (in the order of hundreds of millions of euros over 20 year). This risk/benefit situation may change in the near future as the applicant implements further adaptations and maintenance to the plant aimed at reducing releases and thereby reducing exposures and consequently the health impact. These figures have not been adjusted to account for the shorter review period being recommended by SEAC (i.e., 12 years) as it will not affect the ratio of costs to benefits.

Despite making a thorough search, the applicant has not been able to identify an alternative solvent for the use applied for that is able to produce the same range and quality of products. Should any alternative solvent or process become available, the costs to build a new plant are significantly higher than the monetised human health impacts of the continued use of EDC.

The applicant has made a significant investment in the existing plant, which is well maintained and could be operational for several more decades (very long investment cycle).

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These arguments support a long review period.

The applicant has applied for a 20 year review period, but did not provide a robust justification for this in their initial application. In response to questions from SEAC and in the trialogue, they provided further arguments aimed at supporting this review period. In summary the arguments for a longer review period are:

• The applicant’s desire to maintain their current operations; • An expectation that no new solvent or technology will emerge for a process that is

recognised in the industry BREF guidance as one of the best available techniques and for which major research activity has largely ceased;

• The anticipation that new plant will be needed for any technology that did emerge; and

• A continuing demand for their products (which is supported by relevant market analysis).

Some of these arguments have a merit; in particular, the possibility that an alternative technique will be found in 12 years seems remote. Solvent dewaxing and de-oiling was originally invented in the 1920’s and reached ‘maturity’ in the 1990’s. It can be anticipated that a viable alternative could take up to 7 years to develop and then a further 12-13 to implement (in line with the theoretical implementation of a MEK/Toluene process). This would support a 20 year review period.

Factors indicating that such a long review period could be inappropriate are:

• Despite the market analysis the conditions could be radically different in the next decade;

• Other processes to produce similar products from alternative feedstocks could emerge that would make the solvent dewaxing/de-oiling process obsolete process.

Based on the above considerations and on SEAC’s view on how the length of review period would be established (SEAC/20/2013/03), a review period of longer than 12 years cannot be recommended by SEAC, unless criteria for such period are established. Therefore, SEAC recommends a 12 year review period for this use.

11. Did the Applicant provide comments to the draft final opinion?

YES

NO

11a. Action/s taken resulting from the analysis of the Applicant’s comments:

YES

NO

NOT APPLICABLE

committee for risk assessment (rac) committee for socio

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