The success of the REACH regulation is largely dependent on the chemical industry’s ability and willingness to identify the intrinsic properties of the chemicals placed on the EU market, document these properties and effectively communicate the information to all players in the supply chain. It therefore suffices to say that the defining industry obligation under the regulation is to accurately register information on chemicals to stakeholders in the industry.
With accurate information, the industry can then file a registration dossier to the ECHA, the agency tasked with the implementation of the EU chemicals legislations. Several practices including data sharing obligations, have been put in place to ensure quality chemical information. But, even with exhaustive chemical information exchange among the industry players, the absence of a comprehensive and accurate Chemical Safety Report (CSR) for substances manufactured or imported in annual quantities from 10 tonnes, will mean that a registration dossier will be considered incomplete.
To enhance compliance with the REACH regulation, the ECHA has published several documents to guide the industry in preparing complete CSRs. A key process in the preparation of a CSR is the chemical safety assessment, as it is from the assessment that information to be used in the CSR will be identified.
Annex 1 of the REACH regulation provides the parameters upon which a chemical safety assessment shall be done in order to prepare a CSR. The assessments must cover:human health hazards, physicochemical hazards, environmental hazards and the PBT/vPvB assessment . For substances that meet the requirements of article 58(1) of the CLP regulation, the registrant will additionally perform an exposure assessment and risk characterization.
The objective of the human health hazard assessment is to determine chemical levels which are safe to human health, leading to the appropriate labeling of the chemicals for safe handling. Assessment of the physicochemical hazard determines the explosivity, flammability and oxidising potential of the chemical, which are all instrumental in classification and labeling.
Environmental hazard assessment is important as it sets the lowest concentration effect of the chemical on the environment as well as enabling the registrant to document the chemical’s environmental impact including degradation and bioaccumulation. Annex VIII of the REACH regulation outlines the conditions that substances classified as PBT/vPvB should meet. PBT/vPvB assessments characterize the potential emissions from a substance, a vital piece of information for the chemical’s Safety Data Sheet.
The benefit of the exposure assessment includes determining the lowest chemical concentrations to which humans and the environment can be exposed. It delves into the entire life cycle of the chemical, ending in the simulation of exposure scenario(s) and the Exposure Estimation.
The risk characterization assessment emerges from a chemical’s exposure scenario and considers the estimated number of people exposed to the chemical; both workers in the production sites and other players in the supply chain including the final consumers of the chemical.
All these assessments must be included in the CSR, all of which fall under section B of a standard CSR format, as prescribed by the ECHA. Other information found in the same section includes substance identity together with its physical and chemical properties, as well as its manufacture and use.
Section A of the CSR covers: a summary of risk management measures and a declaration that the risk management measures have been implemented and communicated.
You can get more information on how to prepare as CSR from ECHA’s guidance on CSRs. Assent Compliance can also assist your organization in preparing a CSR.
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