If the dangerous substance is registered in quantities of 10 tonnes per year per registrant, an extended safety data sheet with exposure scenarios attached must be provided.
The exposure scenario describes how to control the exposure of humans and the environment to ensure its safe use.
KBU and exposure scenario
Unlike the main body of the safety data sheet, the format of the exposure scenario is not defined in REACH. The supplier may present this information in different ways and the recipients will receive the information in different formats, which makes it difficult to identify the relevant information.
ECHA and stakeholders have tried to harmonize the layout of the text and the sentences used and have recommended an exposure scenario format that includes the following four sections:
1. title section,
2. conditions of use affecting exposure,
3. exposure estimation,
4. guidance for downstream users to assess whether their use is within the limits of the exposure scenario.
1. Title section
The title section of an exposure scenario usually contains the following information:
a) the uses included in the exposure scenario,
b) the list of relevant tasks/activities included in the contributing scenarios under the exposure scenario,
c) the exposure scenario reference number assigned by the supplier.
2. Conditions of use affecting exposure
This section is the main part of the EC. It contains recommended operational conditions and risk management measures for each contributing scenario. These conditions and measures define the conditions of use of the substance that are safe to evaluate.
3. Exposure estimation
It gives the registrant the opportunity to provide information on:
a) the estimated exposure level using the exposure scenario,
b) risk characterization indicators (must be less than 1, which means that the risks are adequately controlled and the use is considered safe),
c) the methodology used to produce the exposure estimate.
4. Guidance for downstream users to assess whether their use is within the limits of the exposure scenario.
It provides advice to downstream users on how to verify that their use is included in the exposure scenario if their conditions of use do not exactly match the EC supplier.
We will discuss the individual sections in more detail in the following articles.
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