Frequently asked questions
Why do we need Extended-saftey-data-sheets
Extended safety data sheet covers all uses in the life cycle of the substance/raw material/product, from manufacture through to waste. The scenarios must cover company use and downstream customer uses for a product or substance. The e-SDS should contain the following:
Main Technical function of the substance and uses covered in exposure scenarios
Exposure threshold values for human health and environment, these are sometimes determined by your supplier.
Physicochemical data such as vapor pressure, biodegradability, and water solubility. Data is required to carry out exposure assessment.
Exposure Scenarios (ES) with advice on safe use. (E.g. Ensure that eyewash stations and safety showers are close to the workstation location., Remove and wash contaminated clothing before re-use.)
As part of safe use it should include information about risk management measures and waste management measures.
Product Regulatory Services can take an e-SDS provided by companies, some which can be 30 plus pages, and change it to a friendly version for the manufacturers. We can also make an additional 1-2 page document that has all the important information that would satisfy the inspector needs for safety precaution and allow the actual work force to understand the risk of the hazard being used with ease. This document is not meant to replace the e-SDS, just to make the e-SDS user friendly
Why do we need Extended-saftey-data-sheets
If a company exports or imports to the EU, that company must comply with REACH regulation (Registration, Evaluation, Authorization of chemicals). Under the Regulation these companies must have an extended-Safety-Data-Sheet, or e-SDS for each product being shipped into the EU. More countries are preparing to follow reach-like regulations and are going to start adopting needs for component based e-SDS.
What is an Exposure Scenario?
An exposure scenario is conditions that explains how the substance/product is manufactured/used during its life cycle. It also contains information on what manufacturer/importer controls are being used to contain exposures to human and environment.
If you are using a product not covered by one of the Exposure Scenarios presented by the supplier, either intensive testing is required to create an exposure scenario or a request must be submitted to the supplier to include the use the substance is going to be used for.
Can downstream users continue to use a substance, if it has not been (pre-)registered?
Downstream users can use substances, irrespectively of whether they have been (pre-)registered or not. In this regard use means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation. Placing on the market is however not to be regarded as a use.
Please note that for the use of substances (whether (pre-)registered or not) certain requirements related to restrictions, authorisation and risk management may apply. Guidance on how to comply with these requirements is provided in the Guidance for downstream users available on the ECHA website at:
What are my downstream user obligations when my use is not covered by the eSDS?
If as a downstream user you use the substance (as such or in a mixture) outside the conditions communicated to you in the extended safety data sheet (eSDS), or the use is not covered at all in the eSDS, you may choose one of the following options:
Adapt your conditions of use to those described in the eSDS.
Implement or recommend an exposure scenario which includes as a minimum the conditions described in the exposure scenario communicated to you. Make the use known to the supplier with the aim of making it an identified use based on the manufacturer's chemical safety assessment.
Perform your own chemical safety assessment for that particular use and record it in a Chemical Safety Report - CSR (if the total amount used is 1 tonne/year or more). Notify your use, including the information specified in Article 38(2) of the REACH Regulation to ECHA.
Switch to another supplier of the substance if that supplier covers your specific use in his eSDS.
If as a downstream user you receive information from your customers intended to make a use known you should forward this information to the supplier up the supply chain or assess if the use is covered in the existing exposure scenario for the mixture and eventually carry out your own downstream user Chemical Safety Assessment (CSA).
If as downstream user you hold information that puts into question the hazard or risk management information received from the supplier you need to communicate this information to the supplier.
What is REACH and where do I find more information about it?
REACH stands for the Regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals. The REACH Regulation entered into force on 1 June 2007 to streamline and improve the former legislative framework for chemicals of the European Union (EU). REACH also created the European Chemicals Agency (ECHA) which has a central co-ordination and implementation role in the overall process.
If there is any doubt whether your company needs to fufill the requirements of REACH, contact us for a free one time consulting call, We will discuss the requirements and whether they apply to your company.
To which territories does REACH apply?
REACH is a EU Regulation that directly applies in all Member States of the European Union. REACH also applies in Iceland, Liechtenstein and Norway.