Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regulations profoundly affect the way companies do business in the European Union (EU).
REACH introduced new information requirements on the conditions for the safe use of chemicals or mixtures in the supply chain. The new requirements apply only to substances or mixtures meeting the criteria for hazardous classification per the EU system of Classification, Labeling, and Packaging (CLP) Regulation forchemical substances and mixtures (EC Regulation 1272/2008), as amended.
The SDS and eSDS provide a mechanism for transmitting appropriate safety information on substances and mixtures covering end-to-end crucial Regulatory information covering areas like trade, storage, accidental, hazardous classification, and disposal.
Formulators must check whether the foreseeable uses of their customers are covered by the exposure scenarios which they receive.
An eSDS for a substance supplied to formulators would contain exposure scenarios if the exposure assessment was mandatory for the registration of the substance. Formulators must assess whether the foreseeable uses of the customers are covered in the exposure scenarios of the substances.
If the exposure scenarios of the substances do not cover the uses of the mixtures, the formulator has several possible follow-up tasks. At least one actor in the supply chain must do the exposure assessment, risk characterization, and identification of the conditions of safe use if there is no exemption Art. 37.4 is applicable.
The SDS will be extended for the substance or mixture with detailed exposure scenarios, which describe the operational conditions and risk management measures to control the risks for all identified uses.
Hence, Extended Safety Data Sheet = Safety Data Sheet + Exposure Scenario, which is to be supplied, if a hazardous substance is registered in a quantity ≥ 10 tonnes per year per registrant.
There exist two (02) approaches for identifying the correct information to append. These have seen the light with industry’s collaborative efforts to define new processes for meeting the new obligations. The approaches are:
- Bottom-up Approach/Safe Use of Mixture Information (SUMI): The approach starts with the users at the bottom of the supply chain. It is a qualitative method to convey the information regarding the safe use and preventive measures to be followed by the downstream users. The Downstream Users of Chemicals Co-ordination group led the development of this approach.
- Top-down Approach/Lead Component Identification (LCID): It is a quantitative approach and starts with the data from the substance supplier at the top of the supply chain. When no SUMI is available, the LCID method calculates the components in a mixture that contribute the greatest hazards.
These approaches are a major step for communicating safe use information for hazardous substances and for mixtures down the supply chain. REACH does not specify when information from eSDS must be incorporated into the communications. However, REACH requires that SDSs must be updated “without delay”.
Companies should now evaluate their procedures to ensure that they are addressing the new flows of information in the eSDS as well as in the annexes or SUMIs that their suppliers provide. Enforcement authorities continue to demonstrate tolerance regarding timeline obligations of REACH as it is evident that the industry is making good progress and working diligently towards implementing new processes for compliance with this very complex and new set of requirements.
Freyr’s experts, with due diligence, can provide support in the generation of eSDS for hazardous chemicals and mixtures.
Preparation & Management of eSDS
- Identification of Exposure Scenario (ES) parameters based on eSDS or CSR of the substance or the hazardous component present in the mixture
- Identification of use conditions for ES
- Identification of parameters/values with respect to the use of models and specific information from the evaluation process
- Interpretation of the parameters and applying practical occupational conditions/risk management measures
- Compatible formatting as per the best industrial practices