Chemical Safety Data Sheet

Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulations profoundly affect the way companies conduct business in the European Union (EU).

REACH introduced new information requirements for the conditions of the safe use of chemicals/mixtures in the supply chain. The new requirements apply only to substances/mixtures meeting the criteria for hazardous classification, as per the amended version of the EU system of Classification, Labeling, and Packaging (CLP) regulation for chemical substances and mixtures (EC Regulation 1272/2008).

The Safety Data Sheet (SDS) and Extended Safety Data Sheet (eSDS) provide a mechanism for transmitting appropriate safety information on substances and mixtures covering crucial end-to-end Regulatory information on areas like trade, storage, accidents, hazardous classification, and disposal.

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 by the exposure scenarios of the substances.

If the exposure scenarios of the substances do not cover the uses of the mixtures, formulators will have several possible follow-up tasks. At least one (01) actor in the supply chain must conduct the exposure assessment, risk characterization, and identification of the conditions for safe use; if there is no exemption, Art. 37.4 is applicable.

The SDS will be extended for the substance/mixture with detailed exposure scenarios, which describe the operational conditions and risk management measures to control the risks for all identified uses.

Hence, eSDS = SDS + Exposure Scenario, which is to be supplied, if a hazardous substance is registered in a quantity ≥ 10 tonnes per year per registrant.

There are two (02) approaches for identifying the correct information to append. These have seen the light with the industry’s collaborative efforts toward defining new processes for meeting new obligations. The approaches are:

• Bottom-up Approach/Safe Use of Mixture Information (SUMI): This approach starts with the users at the bottom of the supply chain. It is a qualitative method used for conveying information regarding the safe use and preventive measures to be followed by downstream users. The downstream users of the chemical coordination group led the development of this approach.
• Top-down Approach/Lead Component Identification (LCID): This is a quantitative approach that 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 to the greatest hazards.

These approaches are a major step for communicating safe use information for hazardous substances and mixtures down the supply chain. REACH does not specify when information from eSDS must be incorporated into the communication. However, it does mandate that SDSs must be updated promptly, “without delay.”

Companies should now evaluate their procedures to ensure that they are addressing the new information flow in the eSDS as well as in the annexes or SUMIs that their suppliers provide. Enforcement authorities continue to demonstrate patience with respect to the timeline obligations of REACH, as it is evident that the industry is making good progress and working diligently toward implementing new processes for compliance with this complex, new set of requirements.

Freyr’s experts, with due diligence, can provide you with support in the generation of eSDS for hazardous chemicals and mixtures.