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REACH Generic Exposure Scenario

Members of ATC have been working together to develop and communicate information on use descriptors and generic exposure scenarios for common fuel applications for all those involved in the additised fuel supply chain.

1. Outline of Content and Update History

  1. Outline of Content and Update History Version 1 — posted November 2009
  2. Background and Objectives Version 1 — posted November 2009
  3. ATC FA GES Working Group “Workflow” Version 1 — posted November 2009
  4. Requirement for Exposure Scenarios Version 1 — posted November 2009
  5. How to Use this Information - General Version 1 — posted November 2009
  6. Information for Suppliers
    1. Step by Step Guide Version 1 — posted November 2009
    2. Additised Fuel Applications Table Version 1 — posted November 2009
    3. Additised Fuel Use Descriptions for Tier 1 Exposure Assessment Tables (ATC Fuels DUCC Table)
      1. Workers (Industrial/Professional) Version 1 — posted November 2009
      2. Consumers Expected 2012
      3. Environment Expected 2012
    4. Additional Guidance for Suppliers Expected 2010
  7. Information for Customers
    1. Step by Step Guide Version 1 — posted November 2009
    2. Additised Fuel Application Table Version 1 — posted November 2009
    3. Additised Fuel Use Descriptions for Tier 1 Exposure Assessment Table
      1. Workers (Industrial/Professional) Version 1 — posted November 2009
      2. Consumers Expected 2010
      3. Environment Expected 2010
  8. Generic Exposure Scenarios
    1. Fuel Use Group A Expected 2010
    2. Fuel Use Group K Expected 2010
    3. Additional Validation Information Supporting Use of GES Expected 2010
  9. Acronyms/Glossary Version 1 — posted November 2009
  10. Useful Links Version 1 — posted November 2009

2. Background and Objectives

Typical Additised Fuel Supply Chain Diagram

Members of ATC have been working together to develop and communicate information on use descriptors and generic exposure scenarios for common fuel applications to all those involved in the additised fuel supply chain.

The information provided in these web pages is designed to assist suppliers of additised fuel, especially EU manufacturers and/or importers of substances (or in mixtures) for this purpose and to our downstream users (customers). In particular it is aimed at substance manufacturers and importers who need to prepare Chemical Safety Assessments & Reports (CSA/CSR) for REACH registrations and to anyone developing extended Safety Data Sheets (eSDS) for fuel additives and finished additised fuel. Downstream users may wish to use this site to verify the types of fuel-related applications that are likely to be covered by registrants of substances present in additised fuel.

The objective of the ATC Fuel Additives Generic Exposure Scenario Working Group (ATC FA GES WG) in developing these Generic Exposure Scenarios (GES – see Glossary for definition) is to offer everyone in the additised fuel supply chain a useful standardised format, language, and terminology for their exposure scenario assessments. No one is obliged to follow these recommendations, but we believe that you will experience improved communication with your downstream users and/or your upstream suppliers. Similarly, it is expected that they will receive documents in a format and using a set of terms with which they are already familiar. Using these recommendations should also make it very much easier for you to develop Exposure Scenarios for your own products (if necessary) and prepare the extended Safety Data Sheet (eSDS). The goal of this project is therefore to standardise communication in the additised fuel supply chain and considerably reduce your workload by saving time and other resources.

The first version of these web pages was posted on November 2009. The information will be updated and expanded over the coming months.

In order to continually improve the information provided here, the ATC FA GES WG welcomes comments, questions and suggestions from trade organisations or individual companies involved in the additised fuel supply chain. Please send comments (clearly marked for the attention of the ATC FA GES WG) to: [email protected]


3. ATC Fuel Additive Generic Exposure Scenario Working Group – Workflow

The ATC FA GES WG has been active since September 2009, building on the experience and work product of the ATIEL/ATC GES WG which has produced equivalent guidance for lubricant applications. Progress to date and ongoing activities which will lead to updates to these web pages are summarised below.

Workflow Step Status (November 2009)
1. Create a comprehensive list of all additised fuel applications (in industrial/professional and consumer settings) Complete
2. Assign high level ‘exposure determinants’ to all additised fuel applications Complete
3. Group applications by similar ‘exposure determinants’ Complete
4. Test groupings and generate ‘Additised Fuel use descriptions for Tier 1 Exposure Assessment’ (using standard terminology found in Guidance on Information Requirements and Chemical Safety Assessments) – see Section 6.3 and 7.3
a. Workers (industrial / professional), Complete
b. Consumers and In progress
c. Environmental Compartments In progress
5. Add use descriptions for other relevant life cycle stages:
a. Blending, Complete
b. Waste disposal In progress
6. Add information on typical operational conditions and risk management measures In progress
7. Publish initial information on ATC public website, including separate guidance for Suppliers and Downstream Users on their recommended use of this information Complete
8. Request feedback from the Suppliers and Downstream Users on potential gaps, errors and suggested amendments In progress
9. Create Generic Exposure Scenarios for grouped applications In progress
10. Use recommended tools (e.g. DPD+ Methodology) to validate the Generic Exposure Scenario for each grouped application In progress
11. Use recommended tools (e.g. ECETOC TRA) to characterise the risk for a typical fuel additive to demonstrate the use of the information by manufacturers/importers and to ensure validity of the process Not started
12. For each grouped application propose adequate risk modifiers for Tier 2 Exposure Assessment, where Tier 1 default values are shown to be inappropriate Not started

4. Requirement for Exposure Scenarios

REACH requires EU manufacturers and importers to register each of their chemical substances with the European Chemicals Agency (ECHA). Each registration must include a full toxicological assessment of the hazards that the substance presents to man and the environment, and for hazardous substances an assessment of risk to man and the environment. The risk assessment must cover the manufacturing process (if produced in the EU), each supported (i.e. Identified) use and its final disposal as waste. REACH refers to these risk assessments as Chemical Safety Assessments (CSA) and their output as a Chemical Safety Report (CSR).

All registered substances will be evaluated for their hazard. If a substance is determined to be non-hazardous an Exposure Scenario is not required. However, if the substance is determined to be hazardous (including a PBT or vPvB) then an Exposure Scenario will be required if the substance is produced and/or imported at 10 MT or greater.

The first stage in this process is the creation of an Exposure Scenario (ES) for each phase of the life cycle of the substance. The Exposure Scenario describes the life cycle phase being assessed (e.g. substance manufacture), breaking it down into individual process steps (also known as Contributing Scenarios), identifying the degree to which humans or the environment are exposed to the substance at each step and finally how that exposure can be controlled by applying appropriate Operational Conditions and Risk Management Measures. There will therefore be a separate Exposure Scenario for the manufacturing stage (if required), for each different Identified use of the substance and for the final disposal of the substance as waste [2].

In an attempt to simplify this process for companies in the additised fuel supply chain, the WG has used the methods described in the ECHA guidance on Information Requirements and Chemical Safety Assessments to condense numerous different applications of additised fuels and fuel additives to a much smaller number of generic uses. This was possible because many of these applications, though ostensibly different, are actually very similar in terms of human and environmental exposure and can therefore share the same set of Use Descriptors. Only applications utilising additised fuel were considered to be in scope by the ATC FA GES WG who expect another trade association to develop Exposure Scenarios for un-additised fuel streams (such as gasoline and diesel fuel).

[2] Although “wastes” are controlled under the European Waste regulations rather than by REACH, the CSA/CSR should include an assessment of the extent to which humans and the environment are exposed to the substance during final disposal.


5. How to Use this Information – General Guidance

The communication of uses according to the Use Descriptor System is an essential step in developing a Chemical Safety Assessment.In view of the complexity of the registration process (i.e. significant numbers of substances, manufacturers/importers and uses), a common framework is considered necessary to harmonize communication within the additised fuel supply chain to ensure effective and efficient information exchange on Identified Uses between Manufacturers/Importers and Downstream Users.

The following two sections advise on how Suppliers (Section 6) and Downstream Users (Section 7) within the additised fuel supply chain can use the information provided in these web pages (in conjunction with the ECHA guidance if necessary) to ensure that the registration dossiers of substances used in the additised fuel industry sector cover all the relevant Identified Uses and aid in the generation of Exposure Scenarios.

The guidance is divided between Suppliers and Downstream Users since it is anticipated that the information will be used differently depending on your position within the additised fuel supply chain. It is recognised that individual companies can be both a Supplier and a Downstream User and so might need access to both sections of this site.


6. Information for Suppliers

6.1 Step by Step Guide

It is expected that suppliers to the additised fuel supply chain will be aware of approximately 80% of the uses of their substances/products. The ATC FA GES WG therefore recommends that EU manufacturers and/or importers responsible for the registration of substances and formulators adopt the CEFIC/FECC-endorsed “top-down” communication workflow for Identified Uses and associated Exposure Scenarios. The following steps should help you to establish the Identified Uses which you may be asked to cover in your registration dossier for substances you manufacture or import (or pass up the supply chain to the manufacturer/importer if you are a formulator).

Step 1: Identify the additised fuel applications (family and specific application) in which your substance/product is used (e.g. Diesel Fuel / Gas Oil) by referring to the Additised Fuel Application Table (Section 6.2). Make a note of the Grouping (A or K) that has been allocated by the WG to each application. For example:

FUEL APPLICATION

ATC FUEL USE GROUP

Family

Specific application

Diesel Fuel / Gas Oil

Power generation

K

Step 2: Refer to the spreadsheet titled Additised Fuel Use Descriptions in DUCC format’ in Section 6.4 and identify the Use Descriptors - Sector of Use (SU), Process Category (PROC), Product Category (PC) and Environmental Release Category (ERC) - that have been assigned to the Additised Fuel Use Groups you selected.

Additional information to assist with the construction of Exposure Scenarios for workers is given in the ‘Additised Fuel Use Description for Tier 1 Exposure Assessment’ Table (Section 6.3.1) Similar information for consumer uses and environmental release will be given in sections 6.3.2 and 6.3.3 in a future update to these web pages.

Step 3: Confirm within your own organisation that you intend to develop Exposure Scenarios covering these Identified Uses in your registration dossier, or that this will be included by the substance manufacturer/importer if you are a formulator.

Step 4: Communicate the Identified Uses and Exposure Scenarios you intend to support (or your supplier intends to support) to your Downstream Users as soon as possible and at the latest by the end of November 2009 for substances to be registered by 01 December 2010. The deadline for communicating use for substances with a registration deadline of June 2013 or June 2018 is 12 months prior to the relevant registration deadline.

Suppliers to the additised fuel industry should note that all substances used in fuel applications will need to be registered for the Identified Uses allocated to Group A and Group K.

6.2 Additised Fuel Applications Table

Download ATC Fuel Applications Download ATC Fuel Applications

6.3 Additised Fuel Use Description for Tier 1 Exposure Assessment Tables

6.3.1 Workers (Industrial/Professional)

Download ATC Fuels DUCC Table Download ATC Fuels DUCC Table

6.3.2 Consumers

Expected 2010

6.3.3 Environment

Expected 2010

6.4 Additional Guidance for Suppliers

Expected 2010


7. Information for Customers/Downstream Users

7.1 Step by Step Guide

It is expected that suppliers to the additised fuel supply chain will be aware of approximately 80% of the uses of their substances/products. The ATC FA GES WG therefore recommends that EU manufacturers and/or importers responsible for the registration of substances and formulators adopt the CEFIC/FECC-endorsed “top-down” communication workflow for Identified Uses and associated Exposure Scenarios. It is the intention of the ATC FA GES WG members to cover, and/or encourage their suppliers to cover, the supported additised fuel applications and Use descriptors included in the Fuel Applications Table (Section 7.2) and the Fuel Use Description for Tier 1 Exposure Assessment Tables (Section 7.3) in their registration dossiers.

The following steps should help you identify whether your use of a substance/product supplied to you has been assessed as part of this project and assigned a set of Fuel Use Descriptors by the WG:

Step 1: Refer to the Fuel Application Table (Section 7.2) to confirm that your application is listed.

Step 2: Refer to the Additised Fuel Use Description for Tier 1 Exposure Assessment Tables (Section 7.3.1) to identify the Sector of Use (SU), Product Category (PC), Process Category (PROC), and Environmental Release Category (ERC) that has been assigned. (Note that additional information on exposure criteria will be provided in section 7.3.2 and 7.3.3 in a future update to these web pages).

Step 3: If your additised fuel application is covered by the provided Use Descriptors, there is no need to take further action since it is likely that your Use will be covered by the upstream suppliers in their registration dossier.
If your additised fuel application is not adequately described by Steps 1-3 then it is recommended that you contact your Supplier as soon as possible if you want the manufacturer/importer to include your specific use in their registration dossier. In accordance with REACH you, as a Downstream User, can ask the manufacturer/importer (even if it is by way of your supplier who may be a formulator) to include your use in the registration dossier.

However, this communication has to be completed at least 12 months before the respective registration deadline and meaning that for substances with a 1st December 2010 registration deadline this has to be completed by end November 2009 at the latest.

If you decide not to make your particular use known to the manufacturer/importer, or the manufacturer/importer has already informed you that they will not support a particular use because it is deemed not safe, then you may have to develop your own CSA for this use and inform ECHA (see Guidance for Downstream Users), assuming you would like to continue the particular use.

Please note that the process described above is also a feedback loop that will help in the development of the Additised Fuel Applications Table. The ATC FA GES WG has used their best endeavours to ensure that this table covers all the different applications of additised fuel and fuel additives but it is understood that language and nomenclature may differ between individual companies across this sector and so identification of your specific use in the table may be problematic. If you are unable to identify your specific use in the table and you would like to see your particular application included in this project then you should contact your supplier for further discussions.

7.2 Additised Fuel Applications Table

Download ATC Fuel Applications Download ATC Fuel Applications

7.3 Additised Fuel Use Description for Tier 1 Exposure Assessment Tables

7.3.1 Workers (Industrial/Professional)

Download ATC Fuels DUCC Table Download ATC Fuels DUCC Table

7.3.2 Consumers

Expected 2010

7.3.3 Environment

Expected 2010


8. Generic Exposure Scenario for Additised Fuel Use Groups A and K

Expected 2010


9. Acronyms/Glossary

List of acronyms used and what they mean:

Acronym Title Description
SU Sector of Use Describes the area of use, (e.g. manufacture, public domain, private use, etc.) and also the type of industry (e.g. large scale chemical manufacture)
ES Exposure Scenario Covers the set of conditions [usually based around a Process Category (PROC code) for workers, Product Category (PC Code) or Article Category (AC) for consumers or Environmental Release Category (ERC) for the environment] that describe how a substance can be safely used, and which include the necessary operational conditions (OCs) and risk management measures (RMMs) which the M/I considers should be implemented to control the risks to human health and the environment associated with the use. An ES is specific to a substance or product.
GES Generic Exposure Scenario Describes the necessary operational conditions (OCs) and risk management measures (RMMs) which should be implemented to control the risks to human health and the environment associated with the use (or uses) of a group of substances/products with a similar risk profile within a general area of industry (and may extend across several PROCs, PCs/ACs or ERCs). By definition, it aggregates the individual Exposure Scenarios for the various tasks and activities that constitute the general use of the substance/product within a specific sector. It is developed by M/Is in partnership with DU associations.
UD Use Descriptor The term used in REACH to describe the PROCs, PCs, ERCs and SUs.
PROC Process category How the substance is being used (e.g. spraying in industrial settings or applications).
PC Product category Type of product (e.g. hydraulic fluid).
AC Article category Type of article (e.g. rubber product: tyres).
ERC Environmental release category A conservative set of exposure conditions that is intended to ensure that releases to the environment from an use (e.g. industrial use of substances in closed systems) do not represent a cause for concern
SPERC Specific ERC An ERC, developed by industry, and based on realistic data and assumptions for a particular use.
OC Operational conditions What happens during manufacture or use (e.g. pumped transfer from closed mixing vessel to drum)
RMM Risk management measures Actions taken to reduce exposure to an identified hazard (e.g. use of closed vessel to prevent exposure to vapours)
ECETOC European Centre for Ecotoxicology and Toxicology of Chemicals ECETOC is a scientific forum for chemical companies to harness their specialist expertise to research, review and assess the ecotoxicology and toxicology of chemicals.
ECETOC TRA ECETOC Targeted Risk Assessment A tiered (step-wise) approach for calculating the exposure to (and risks from) chemicals that might reasonably be expected from defined circumstances of use addressing exposure to consumers, workers and the environment.
DUCC Downstream Users of Chemicals Co-ordination Group Informal platform of European associations which represent “downstream” industries ranging from cosmetics and detergents to aerosols, paints, adhesives, photographic and construction chemicals and chemical distributors industries.

10. Useful Links


11.Q&A

Under development