Exposure Scenario

CEPRA srl proposes services for editing and evaluating exposure scenarios attached to the SDS under REACH.

• Predisposing and evaluating exposure scenarios for substances
• Preparation and evaluation of exposure scenarios for blends in accordance with the principles of USE MAPS (SUMI)

An extended safety data sheet, with exposure scenarios attached, has to be supplied if a hazardous substance is registered in a quantity above 10 tonnes per year per registrant.

An exposure scenario refers to an identified use, or group of similar identified uses. Exposure scenarios may include a number of “contributing scenarios”. A contributing scenario describes each contributing activity within the identified use.

The uses are divided into:

• industrial uses;
• professionals uses
• consumer uses

FORMAT OF EXPOSURE SCENARIO

Unlike the main body of the safety data sheet, the format of the exposure scenario is not defined in REACH. ECHA and stakeholders have worked to harmonise the layout and the phrases used, and recommend a format for the exposure scenario which includes the following four sections:

• Title section;
• Conditions of use affecting exposure;
• Exposure estimation;
• Guidance to downstream users to evaluate if their use is within the boundaries of the exposure scenario.

The exposure scenarios will have for substances, many of which later end up in the formulation of mixtures. For dangerous mixtures can:

• Provide consolidated safe use information for the mixture as an annex to the safety data sheet; or
• Incorporate consolidated safe use information for the mixture in the main body of the safety data sheet, mainly in Section 8; or
• Attach relevant exposure scenarios for the ingredient substances as an annex to the safetydata sheet.

When you receive an extended safety data sheet it means that the exposure scenarios are attached, so you need to:

1. identify the exposure scenario describing the identified use of the substance
2. check whether the identified use and conditions of use described are consistent with the use and the conditions of use in practice. (It may happen to have the same use but different conditions of use, and then you need to prove if you fall or not in this exposure scenario.)

When you receive a safety data sheet, check if a registration number is provided in Section 1.1 (for substances) or 3.2 (for mixtures). If so, you have 12 months to implement the conditions of use included in any exposure scenarios received for your use or to take appropriate actions.

1. TITLE SECTION gives following information:

- Uses covered by the exposure scenario: This information gives a brief description of the scope of the exposure scenario in the ES name. It may provide information on the life cycle stage (e.g. use at industrial site) and market information (e.g. use in paints, use in manufacturing of electric appliances). The short title may also include additional elements such as technical process and level of containment.

- List of applicable tasks/activities covered by contributing scenarios within the exposure scenario: This information includes the name of the contributing scenario and the assigned use descriptors.

- The reference number of the exposure scenario

- The information in the Title Section usually includes use descriptors

They include information on:

• Life cycle stage: such as formulation or re-packing, use at industrial sites, widespread use by professional workers;
• Market sector: such as Product Category (PC) Sector of Use (SU) or the Article Category (AC);
• Application or process type: Process Category (PROC);
• The type of release to the environment: Environmental Release Category (ERC).

2. CONDITIONS OF USE AFFECTING EXPOSURE

This section is the core of the ES. It presents the recommended operational conditions (OCs) and risk management measures (RMMs) for each contributing scenario. These define the “conditions of use” of the substance that have been assessed as being safe.

The “operational conditions” (OCs) are a set of information on the use of a substance. They describe the types of activities to which the exposure scenario relates: how much, how often and for how long a substance is used and in which types of process, at which temperatures it is used etc. The parameters that influence the exposure level are included in the exposure scenario you receive.

The term “risk management measure” (RMM) means an activity or device that reduces or avoids the exposure of humans and the environment to a substance during its use. Risk management measures applied in industrial uses include local exhaust ventilation (LEV), personal protective equipment (PPE), waste gas incinerators or onsite and municipal waste (water) treatment.

If the exposure scenario contains several contributing scenarios, section 2 will include the operational conditions and risk management measures related to each contributing scenario

3. EXPOSURE ESTIMATION gives information ob:

• The estimated level of exposure when the exposure scenario is applied;
• The “risk characterisation ratio” (this has to be less than 1 to indicate that risks are properly controlled, and the use is considered safe);
• The methodology used to develop exposure estimation.

Exposure estimation software is used to predict exposures to workers, consumers or the environment for a given set of conditions of use. The risk characterisation ratio is obtained by dividing the exposure estimates by corresponding threshold levels (i.e. DNEL for human health or PNEC for the environment).

4. GUIDANCE FOR DOWNSTREAM USERS TO EVALUATE IF THEIR USE IS WITHIN THE BOUNDARIES OF THE ES includes advice to the downstream users on how they can verify that their use is covered by the exposure scenario if their conditions of use do not match the supplier’s ES exactly.

One of the verification methods is known as ‘scaling’.

The information provided by the supplier should include:

• Scaling method: this could be a mathematical formula, a link to a website with a scaling tool or a reference to the exposure estimation tool used by the supplier for the assessment;
• Scalable parameters: these are the operational parameters which can be scaled;
• Boundaries of scaling: this indicates to what extent the parameters could be changed.

Scaling can only be applied if the supplier has used a modelling tool to estimate the exposure to humans and the environment.

When your conditions of use differ from those indicated in the exposure scenario, the estimated exposure levels and the risk characterisation ratio may also differ.

To apply scaling you should:

• Check your use against the exposure scenario and/or contributing scenario received from your supplier;
• Identify the conditions (parameters) that differ;
• Check if differing parameters are identified as scalable parameters by the supplier;
• Input your parameters in the scaling tool received from the supplier;
• Check the resulting level of exposure (or RCR) and compare it with the level of exposure (or RCR) in the corresponding contributing scenario, given in Section 3 of the ES.

To conclude that the use is covered by the ES, the resulting level of exposure after scaling is applied has to be the same or lower than the level of exposure indicated in Section 3 of the ES (for the corresponding contributing scenario).

If the supplier does not support scaling, or scaling shows that the exposure level has increased from that in the supplier exposure scenario, you have the following options:

• Implement the conditions in the exposure scenario; or
• Ask your supplier to cover your use; or
• Perform a downstream user chemical safety assessment.

Scaling cannot be applied if the registrant has based the assessment on measured exposure data.

If as a registrant, you have used a modelling tool to estimate the exposure to humans and the environment then provide details of the tool here, or a simplified mathematical method that could be applied by the downstream user if you deem scaling appropriate.

CEPRA srl is able to draw even SDS in accordance with the regulations of the major markets outside the EU in order to facilitate your import / export activities (China, Korea, South America, Canada, USA ...).

Contact us for more information.