Guide: Exposure scenario module

This article has been translated with machine translation.

Work efficiently with exposure scenarios and risk assessment in iChemistry

1. Introduction

The exposure scenario module in iChemistry helps your organisation manage the exposure scenarios that suppliers send along with safety data sheets for chemical products. The module is closely linked to the risk assessment module, and together they ensure that you take a structured approach to deciding on, documenting and signing off decisions about how your products are used in relation to the conditions set out in the exposure scenarios.

This guide covers the background to what an exposure scenario is, which products require one, how the exposure scenario module works in practice, how exposure scenarios are handled in the risk assessment, how Intersolia's update service works, and how to resolve the common message "Exposure scenario is included in the SDS".

2. What is an exposure scenario?

An exposure scenario is a document that describes how a chemical may be used and manufactured, so that the risks to human health and the environment are controlled throughout the product's life cycle. The exposure scenario forms part of the chemical safety assessment carried out under the EU's REACH chemicals legislation, and is primarily relevant to organisations operating within the EU/EEA and the UK.

2.1 Legal background

Exposure scenarios are mandatory when a manufacturer or importer registers a substance in volumes of more than ten tonnes per year, and the substance is also classified as hazardous or is a so-called PBT/vPvB substance (persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative, respectively). This means that exposure scenarios do not exist for all chemicals on the market – only for substances that meet these criteria.

2.2 Format

An exposure scenario can be provided in two ways:

• As a separate, stand-alone document attached to or sent together with the safety data sheet.
• Built into the safety data sheet itself, as an extended annex – in which case it is called an "extended safety data sheet" (eSDS).

For mixtures, the corresponding requirement applies when the mixture is classified as hazardous and contains at least one registered substance at a concentration that corresponds to a total registered volume of more than ten tonnes per year.

2.3 Practical guidance – how to check whether your use is covered

1. Check section 1.2 of the product's safety data sheet. This states which identified uses the exposure scenario covers.
2. Compare your actual handling of the product against the uses and risk-reducing measures described in the exposure scenario.
3. If your use is not covered, there are four main options: contact the supplier for clarification, adapt your use so that it is covered, switch to a supplier whose scenario covers the use, or carry out your own chemical safety assessment under REACH Article 37.

3. Which products require an exposure scenario?

Since not all chemical products are subject to the exposure scenario requirement, your organisation first needs to determine which products are relevant to work with. Intersolia offers an update service (see section 5) that helps obtain exposure scenarios from suppliers, but the service needs to be aimed at the right selection of products to be effective.

3.1 Selection criteria

A product should normally be included in the selection if it meets at least one of the following:

• The product contains only one substance (a single-component product).
• The product contains a substance with a REACH or UK REACH registration number.

Exposure scenarios can also occur for mixtures containing several substances, but this is not covered by the general selection criteria above and instead requires manual review on a case-by-case basis.

3.2 Legal requirements governing the selection

• REACH Article 14 requires that a chemical safety report be produced for substances registered at ten tonnes or more per year and per registrant.
• REACH Article 37 requires downstream users to identify and apply appropriate risk-reducing measures – with the exception of substances used in quantities of less than one tonne per year.

3.3 Recommended workflow when starting up

1. Sign a contract with Intersolia for the relevant add-on service.
2. Implementation and system configuration in iChemistry.
3. Building the organisation tree (departments and sub-departments).
4. Product inventory by department.
5. Digitising safety data sheets in the system.
6. Selecting products according to the criteria above.
7. Adding the selected products to a dedicated department or list.
8. Concluding the selection work with a final product count as the basis for the service.

4. The exposure scenario module – overview and workflow

The exposure scenario module is an add-on function in iChemistry that gives you a combined overview of all products with associated exposure scenarios, organised according to your department structure. The module is the natural starting point for systematically working through and documenting decisions on exposure scenarios.

4.1 How to find the module

Navigate to Tools > Exposure scenario in iChemistry. The list shows all products with associated exposure scenarios, sorted by how far the handling has progressed.

4.2 Three categories in the product list

• Unhandled exposure scenarios – marked with a flag and should be prioritised.
• Overarching decisions on exposure scenarios – decisions that apply to the product across several departments.
• Department-specific decisions on exposure scenarios – decisions that only apply to the selected department and its sub-departments.

4.3 Step by step: handling a decision

1. Click on a product in the list to open its decision page. Here you can see, among other things, where the product is inventoried and which risk assessments are linked to it.
2. Check the "Date received" field, which shows when the exposure scenario document was received from the supplier. If needed, you can attach additional documents.
3. Select the decision status from the drop-down menu, add a comment justifying the decision, and then choose to save it as a draft or sign the decision straight away.

4.4 Status values

4.5 Decision scope: overarching versus department

An overarching decision applies to the product across several departments at once, while a department-specific decision only applies to the department you are currently in and its sub-departments. Greyed-out rows in the list show decisions made in another department that still apply to your department – these can, if needed, be adapted locally for a sub-department by clicking "Adapt".

4.6 Tips and best practice

• Make sure you are on the correct department in iChemistry to also see archived decisions for that department.
• Prioritise products flagged as unhandled – they require an active decision.
• Take advantage of the fact that linked SDS and risk assessment documents are directly accessible from the product list, so you don't need to search in several systems.
• Let sub-departments create local adaptations when their use differs from the overarching decision, instead of creating entirely new, unrelated decisions.

5. Exposure scenario in the risk assessment

In addition to the stand-alone exposure scenario module, exposure scenarios are also handled directly in the risk assessment module, in cases where a product with an associated exposure scenario is included in a risk assessment. The status column "Assessment type" shows whether the decision was made at product level ("Product") or within the risk assessment itself.

5.1 Where in the risk assessment does this happen?

Navigate to Tools > Risk assessment > To do > Exposure scenario. When a product in the risk assessment has an associated exposure scenario, a red flag is shown in the final step of the risk assessment, which must be handled before the risk assessment can be completed.

5.2 Step by step in the final step of the risk assessment

1. Assess whether the current activity/product use is covered by the exposure scenario.
2. Make a decision via the drop-down menu based on the assessment.
3. Add a comment justifying the decision, and attach any supporting investigation documents.
4. Confirm the handling by clicking "Done".

5.3 Three possible scenarios

• Already handled: a green check mark is shown, and there is an option to make a new, activity-based decision about that specific use.
• Department decision already made: a separate field is shown for making an activity-specific compliance assessment based on the overarching department decision.
• No scenario linked: the status becomes "Possibly not required" and is marked green.

6. The update service for exposure scenarios

The update service is an add-on service from Intersolia that makes it easy to monitor the status of your products' exposure scenarios. Status is shown collectively in the overview function in iChemistry, giving you a quick picture of where each product stands in the process.

6.1 The four status groups

6.2 The process's status phases

1. Waiting stage: the product is queued for an update while supplier contact is initiated.
2. Awaiting supplier response.
3. Completed: the process is marked as finished once the update is complete.

6.3 Possible outcomes when an exposure scenario is obtained

• No exposure scenario is available from the supplier.
• The supplier states that an exposure scenario is not mandatory for the product.
• An existing version you already have is the latest one.
• The exposure scenario is included in the safety data sheet (see section 7).
• The exposure scenario exists as an attachment.
• The exposure scenario is only available in a foreign language.

6.4 Good to know

Different language versions of an exposure scenario count as separate documents and can therefore have different statuses. This explains why the number of products in each status group sometimes doesn't add up as expected.

Organisations can limit update requests to specific departments for relevant products. This type of custom configuration is set up via Intersolia's customer service.

7. Common issue: "Exposure scenario is included in the SDS"

A message that many users encounter in iChemistry is "Exposure scenario is included in the SDS" when they click on a product's exposure scenario. The message can seem confusing, as it isn't always clear how to proceed.

7.1 Why the message appears

Intersolia's SDS department continuously asks suppliers for updated safety data sheets and exposure scenarios. In some cases the supplier sends a separate document for the exposure scenario, but in other cases the supplier replies that the scenario is already built into the safety data sheet itself – which is exactly what the message in iChemistry indicates. Since you then only see a regular safety data sheet without a clearly separated exposure scenario section, it can seem as though the document is missing.

7.2 Recommended action

1. Contact the supplier and request a separate exposure scenario document that describes your specific work task.
2. Send the document you receive from the supplier to Intersolia's SDS department at sds.se@cs-environment.com, and they will update the material in the system for you.

8. Summary – recommended way of working

To work efficiently with exposure scenarios in iChemistry, the following order of work is recommended:

1. Make sure you have made a correct product selection according to the criteria in section 3, possibly with the help of Intersolia's update service.
2. Follow the status in the update service's overview to see which products are awaiting a supplier response, are handled, or require action.
3. Work systematically through unhandled exposure scenarios in the exposure scenario module (Tools > Exposure scenario), and make and sign decisions at the right organisational level – overarching or per department.
4. Let the risk assessment module capture activity-specific assessments when a product with an associated exposure scenario is included in a risk assessment (Tools > Risk assessment > To do > Exposure scenario).
5. If the message "Exposure scenario is included in the SDS" is shown: request a separate document from the supplier and send it to the SDS department for updating.
6. Always document decisions with a clear comment, so that the reasoning is traceable for future follow-up and for other departments affected by the same product.

Sources

This guide is compiled from the following articles in Intersolia's knowledge base:

• The exposure scenario module
• Overview – update service for exposure scenarios
• Exposure scenario in the risk assessment
• Exposure scenario is included in the SDS
• Selection of products that require an exposure scenario
• What is an exposure scenario?