Environment

SPERCs may be used in various environmental safety assessment tools described below.

1. ECETOC-TRA and EASY TRA: Insert the relevant uses, tonnage, PNECs and substance properties into the tool, along with the correct selection of SPERCs. When this step is complete, select advanced batch calculations in the ECETOC TRAv3 tool to generate exposure estimates and the environmental Risk Characterisation Ratios (RCR)..
2. Chesar: The IUCLID substance data file must be imported to Chesar, complete with the required Chesar input. Identify the appropriate uses and enter tonnage for each stage in the life-cycle. Select the correct SPERC identified from the CEFIC use map, and select the ‘assessment’ mode to calculate emissions and exposure per use.
3. Petrorisk: SPERCS, SubSPERCS, and ERCs are pre-defined in this tool and linked to uses. You only need to enter the use and tonnage.
4. EUSES: Look up the release fractions from the appropriate (Sub)SPERC and insert values into relevant fields under the section, ‘Release fractions and emission days’.

The output of these tools is a series of Risk Characterisation Ratios (RCRs), based on predicted environmental concentrations (PECs) / predicted no effect concentrations (PNECs), for individual environmental compartments. If RCRs are less than one, the OCs and RMMs used in the assessment describe conditions of safe use and the associated narrative ES remains valid.

If the RCR is greater than one, then additional Risk Management Measures (RMM) or more stringent Operating Conditions (OC) are necessary. The result of these interventions should lead to an RCR less than one.

Some explanation of the values found in a SPERC and how they may be used are as follows:

• SPERC title – Identifier, mapped to GES title and ERC(s) that can be used for reference in REACH related documents, such as exposure scenarios, and is also the title of the corresponding SPERC fact sheet.
• SPERC code – Informs user of which SPERC to select within the assessment tool (eg. ECETOC TRA, CHESAR)
• Maximum/Typical site tonnage (Msperc) – Site tonnage upon which local scale exposure assessments may be based. May be overwritten with own use rate.
• Number of emission days per year – Typical/default frequency of use. Used to derive annual tonnage from daily amount and vice versa.
• Release to air (%) before risk management measures (RMM) – Estimate of proportion of substance released to air from process, compared to amount used. For some SPERCs, multiple values are given, based on vapour pressure. User needs to select relevant release fractions based on own substance properties.
• Efficiency of air emission control– Assumed onsite risk management measure removal efficiency for substance released from process to air.
• Release to air (%) – Remaining percentage of substance released to air compared to substance used, after removal by RMMs.
• Release to wastewater (%) – Estimate of proportion of substance released to wastewater from process, compared to amount used. For some SPERCs, multiple values are given, based on water solubility. User needs to select relevant release fractions based on own substance properties. Note, wastewater RMM removal efficiencies and subsequent release fractions are typically substance- and site-specific, and therefore are not explicitly assumed in the SPERC.
• Release to soil (%) – Estimate of proportion of substance released to soil from process, compared to amount used. RMMs are not assumed.

• The value for Emission Days is linked to MSPERC and ECHA’s Chapter R-16 guidance on Environmental Exposure Assessment. If MSPERC is not applicable for an assessment (i.e., when Regional tonnage is less than MSPERC), the assessor should confirm the appropriate value for Emission Days is included in the assessment
• There are two sets of Release Fractions to Air: i) ‘prior to RMMs’ and ii) ‘with RMMs’. For the purpose of assessment the Release Fraction ‘with RMMs’ should be used, however, communication in the Exposure Scenario should be consistent with the assumptions made (i.e., release from the process is driven by the Release Fractions ‘prior to RMMs’ with the implementation of some RMM removal efficiency for air, that provides a final Release Fraction ‘with RMMs’.
• For many industrial use SPERCs, Release Fractions to Wastewater have been developed using the concept of substance solubility and wastewater volume generated during the process. A critical assumption to this method is that no free product is releases in the effluent stream. This is an important boundary condition that may or may not have implications on RMMs (i.e., whether or not oil-water separation is required onsite), and thus should be explicitly communicated in the Exposure Scenario.
• It is a default assumption when using SPERCs that offsite/municipal wastewater treatment is applicable. In the ECETOC TRA model, some pre-defined SPERCs also have built-in typical onsite removal efficiencies. This is not the case for the pre-loaded ESIG/ESVOC SPERCs because we did not want to be prescriptive of what efficiencies are achievable onsite. Consequently, if the assessment using an ESIG/ESVOC SPERC results in RCRs > 1, it is possible to refine the wastewater release fractions to simulate onsite RMM removal efficiencies. This is achieved by first defining the required onsite removal efficiency: REonsite = 1 – 1/RCRrisk-determining, where RCRrisk-determining is the highest RCR that is driving the risk. The release fraction for wastewater is then reduced by the fraction of REonsite, which results in a new release fraction that is used to re-run the assessment. In order to re-run the assessment, the assessor will no longer be able to select from the pre-defined dropdown list of SPERCs, but will instead have to enter the SPERC data manually into the OECD approach section of the tool and run a surrogate assessment
• It is important to note that if an assessment results in RCRs > 1, it may not always be due to wastewater releases (e.g., it may be an endpoint that is air release driven). In either case, it will be the responsibility of the assessor to determine how to implement this refinement approach (i.e., reduction of air release fraction and/or wastewater release fractions). Furthermore, for communication purposes, the assessor will have to explicitly indicate the process related release fractions, calculated onsite RMM removal efficiencies used, and the applicable offsite/municipal RMM removal efficiency. To assist in this step, results from the TRA model can be summarized into a concise aggregated table using a ‘Transcription’ tool that has been developed and is available for use from ECETOC TRA.