Demystifying the SEA
It has been said that an economist is: “Someone who solves a problem you didn’t know you had, in a way you don’t understand.”
In the context of REACH Authorisation, however, the problem is, in most instances, quite clear: stop using the Annex XIV substance and face the economic consequences of that, or try to prepare an Authorisation application while justifying the continued use of the substance on socio-economic grounds. The complexity and nuance of undertaking such a task, coupled with the pressure from the potential consequences of not doing it correctly, could mean that it might be more prudent to allow an experienced practitioner to do it for you. Nevertheless, in this newsletter we try to demystify the SEA
Where to Start?
1. Definition of the relevant supply chain
The relevant supply chain can be identified by determining the material flow related to inputs to and outputs from the uses covered by the authorisation application and economic flows through affected markets. Supply chains are case specific but they usually include suppliers, the applicant, distributors, customers and possibly even consumers.
2. Definition of the in-use scenario
This is the baseline scenario; business as usual, and describes the situation that would arise if no regulatory action was taken. A proper in-use scenario should include an historical trend, current situation and future forecast of the business for all relevant players in the supply chain. The focus on the applicant is, of course, the most significant.
3. Definition of the non-use scenario
This is the scenario in which an authorisation application for use of a substance is not granted and you must stop using it. How would you and the relevant actors in the supply chain react? Credibility is hugely important when defining a non-use scenario. If it is not credible then it might be questioned, weakening your argument for authorisation.
4. Definition of the impacts
What kind of impacts the non-use scenario causes in the relevant supply chain in terms of human health, environmental, economic, social and wider economic impacts? These should be expressed, when possible, quantitatively. Monetisation is the key which enables the comparison between the in-use and non-use scenario in the analysis phase. Correct and reliable monetisation can prove to be very tricky.
5. Analysis
Last but not least is the analysis where the focus is in the differences between the in-use and non-use scenarios i.e. comparing the risks against the benefits of a granted authorisation in monetary terms.
Sometimes the goalposts can change; meaning that more information is required for example, if there is an additional SVHC property of your substance. The hot topic at the moment is how to manage human health and environmental impacts with endocrine disrupting and other environmentally hazardous substances. As we speak ECHA is preparing Q&As which may clarify what approach can be taken. Before the publication we can only say for certain that a well justified non-use scenario, monetised benefits of continued use, qualitative information on releases, together with quantified releases and environmental concentrations, description and justification of risk management measures should be enough to conclude that benefits outweigh the risks.
Our Support:
Our extensive experience of having prepared SEAs in all of our authorisation applications makes possible to help you cope with today’s demanding REACH Authorisation challenges.
Need support? Write us an email to: sales@reachlaw.fi. We would be happy to assist you.
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