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European Safety Data Sheets
With the implementation of REACH, all of our Safety Data Sheets in Europe have been revised. To help you understand the changes we have produced an interactive guide. The questions and answers below provide further guidance on specific points.
If you would like to understand the structure of Europe's Safety Data Sheets and identify the specific changes that have been made, link to our interactive guide.
Further guidance is included in the questions and answers below.
Updated Safety Data Sheets have been sent to customers, but if you would like to make a search now, link to our Safety Data Sheet finder.
1) What is an Exposure Scenario?
An ‘Exposure Scenario’ describes how a substance may be handled to control exposures to both human health and the environment. The full REACH definition for an Exposure Scenario is as follows:
‘Exposure Scenario’ means the set of conditions, including operational conditions and risk management measures, that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment.
2) When are Exposure Scenarios required under REACH?
Exposure Scenarios (ESs) are required to be developed for the identified uses of substances that are sold in quantities of more than 10 tonnes per year and are classified as dangerous. If safe use can be demonstrated, the associated ESs will be appended to the extended-Safety Data Sheet (e-SDS). Those uses for which safe use cannot be demonstrated will be identified as ‘unsupported uses’ and also reported in the SDS.
Where appropriate, Shell has prepared ESs for the identified uses of our products as part of the development of our substance Chemical Safety Assessments. These ESs are currently being incorporated into an update to our Safety Data Sheets, known as an extended-Safety Data Sheet (e-SDS).
In defining ‘use’ Shell has applied the ECHA Guidance on information requirements and chemical safety assessment, Chapter R12: Use descriptor system.
3) What should customers do on receipt of an SDS containing Exposure Scenarios?
When customers receive an updated SDS for a product requiring ESs, they will need to identify the relevant ES(s) for their particular uses. In addition, they will need to review the ESs to check whether their local situation is consistent with the operating conditions and risk management measures identified in the ES for the demonstration of safe use.
If a Downstream User’s (DU) use, or the conditions of use, does not appear to be covered, the DU has 12 months (REACH Article 37) from the receipt of the e-SDS to contact the supplier to request that they consider including their use/use conditions in their registration. In Shell, we have tried to be comprehensive and it is likely that some alignment on the identification of use is necessary rather than an actual gap.
4) If a product is classified as dangerous, why is there no exposure scenario on the eSDS?
- for substances
The risk management measures for preventing the health hazards associated with the physico-chemical properties of a substance - such as those classified as R65/H304 (Harmful: may cause lung damage if swallowed/May be fatal if swallowed and enters airways) or R66/EUH066 (Repeated exposure may cause skin dryness or cracking) - are the same regardless of the type of exposure scenario.
For R65 classified substances, precautions are needed against ingestion and for R66 precautions against skin contact. In these cases, the advised risk management measures are included within the main sections of the SDS as they are applicable in all circumstances when handling these substances.
- for mixtures
For our mixtures, an exposure scenario is only required when we receive information that causes us to change the risk management measures or classification based on new hazard information or when we have received all the exposure scenarios for the risk determining substances.
5) Why are no registration numbers included on an eSDS?
Polymers and other substances exempt from REACH registration do not require a registration number.
For mixtures, there is no requirement to add registration numbers to our eSDS for all components. We will be adding the substance specific element of the registration numbers of the hazardous components in our eSDS when we re-issue the eSDS. For the eSDS of a mixture containing no hazardous substances, or containing hazardous substances below the level that triggers a classification of the mixture, then no registration numbers are required.
6) Why is only one registration number on the eSDS if the product contains many components?
Please refer to the answer to Question 5.
7) Why did I receive an eSDS when I have not purchased this product for a while?
This is because we have revised our eSDS and all customers who have received the product in the last 12 months automatically receive an update.