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A substance becomes a substance of very high concern (SVHC) when it meets one or more of the criteria such as carcinogenic, mutagenic, toxicity for reproduction, PBT; and/or if there is scientific evidence of possible serious effects to human health or the environment. Once this type of substance is identified, one of the possible Risk Management Options open to the authorities is Authorisation, meaning that any user of the substance must apply for a specific permission for that use.

The Chemical Safety report is one of the elements required when assessing the safe use of an SVHC in an Authorisation application. It describes the uses applied for covering the properties of the Annex XIV listing and includes a chemical safety assessment (CSA).

The CSA consists of the evaluation of all available information with the purpose of assessing the risks arising from the use of the substance covering all the life cycle stages of the use of the substance, from procurement to waste, as such or in a mixture.

An evaluation of exposure is developed, including consideration for any Risk Management Measures (RMMs) like technical controls, operational conditions and use of personal protective equipment (PPE), etc. that are in place for the process to avoid or reduce the human exposure. Furthermore, the Environmental exposure identifies the environmental emissions that should be minimised using technical controls, operational controls and suitable waste management measures. Moreover, an assessment of the likelihood of exposure to humans via the environment is also included when this is considered necessary.

This information will be reported in exposure scenarios which aid the authorities in deciding if there is safe use of the substance and/or products containing the substance by demonstrating the controls in place. Consequently, the information reported in the CSR is crucial for a successful Authorisation application.

In summary, an accurate assessment on how the chemical is used will be documented in the CSR and it will serve to prove safe use of the substance and/or products containing the substance.

What can be done to ensure an effective assessment?

During the course of the assessment, questions like:  Is the substance in general suitable to be widely used by untrained workers in small business and by consumers? Which types of exposure controls are needed at work places to handle the substance safely? or How much of a substance can be used per day at an industrial site without onsite pre-treatment of wastewater? will facilitate the elaboration of more precise conditions and allow the refinement of exposure estimations. Likewise, in many cases, the use of the substance is geographically spread across Europe and the identification of all the sites where it is used is critical. Therefore, efforts need to be put in the understanding the What, Where and How your supply chain makes use of the SVHC substance or SVHC containing mixture.

Potential consequences for your business due to inappropriate CSRs

It needs to be understood that substances on the Authorisation list are considered the worst of the worst in terms of potential negative impacts to humans or the environment from exposure. For these SVHC substances, in our experience, the authorities have strict interpretations of what they will think are suitable risk management measures, and will always s augment these with their own suggestions in their opinion.

A chemical safety report is, consequently, key to demonstrating to the authorities that all measures in place by you and your supply chain are sufficient to mitigate any risks from the hazard. A CSR that has been prepared correctly for an Authorisation application reduces the uncertainty in the eyes of the authorities and strengthens the case for a positive decision on Authorisation.

Furthermore, from a practical point of view, the CSR is the basis for the compilation of the extended Safety Data Sheet (e-SDS) that should be updated and distributed to your supply chain on granting of an Authorisation.  It is, therefore, not only important for you that the CSR is prepared properly, but also for your downstream supply chain.

Once completed, what benefits can we get from a CSR?

Adherence to the RMMs in the CSR will contribute to the safe use and handling of SVHC substances, ensuring your workers, the public and the environment are protected from potentially hazardous and negative effects.  It can also act as a baseline from which additional RMMs can be added, ensuring continuous development in the safe use of such substances within your processes.  

Furthermore, the exposure scenarios contained within the CSR should be appended to the extended safety data sheet (e-SDS) which allows for communication of the risks and hazards along the supply chain, when required.

In short, this document will help you to maintain and manage your product and processes safely, while giving the authorities confidence that you are doing everything in your power to ensure the minimization of risks from the use requiring Authorisation.