REACH: Background

REACH requires European Union 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 (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. If the substance is determined to be hazardous however (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, 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*.

In an attempt to simplify this process for companies in the lubricants supply chain, the ATIEL/ATC Generic Exposure Scenario Working Group has used the methods described in the European Chemicals Agency (ECHA) guidance on Information Requirements and Chemical Safety Assessments to condense several hundred different applications of lubricants and lubricant 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.

*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.