In June, the European Chemicals Agency (ECHA) announced its plan to revise the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation’s authorization process. The updates will improve clarity surrounding scientific opinion on authorizations, and introduce new requirements for making a submission.

These changes are the result of a recent European Court of Justice decision that overturned existing authorizations. The case is believed to be just one of many instances where companies have submitted non-compliant authorization dossiers.

Learn more about Assent’s REACH solution, and find out we can help you prepare for changes to the authorisation process.

Three Changes to the Authorization Process

There are three main components of the update. Perhaps the most important of these is the requirement that companies create a substitution plan for any Substances of Very High Concern (SVHCs) in their products. It has been commonly stated that the real purpose of REACH is not to take products off the market, but to drive the research, production and implementation of safe alternatives to hazardous substances. The update to the legislation urges companies to think about their requirements beyond a compliance-only approach, and submit a plan to show they intend to transition to compliant substances.

In order to create these plans, companies will need to perform analysis and testing to determine whether there are any existing substances that could be used as alternatives to harmful ones. The ECHA asserted that companies should list alternatives even if the proposed new substance is not a feasible option at the time.

The other two changes are related to the opinion texts provided by scientific bodies to show how conclusions regarding the authorizations were reached. The ECHA intends to revise the opinion formats used by testing bodies, such as the Committee for Risk Assessment (RAC) and the Socio-Economic Analysis Committee (SEAC), to be more clear and promote understanding.

To this end, opinion texts will also be standardised to support rapporteurs in building consistent, concise documents that stakeholders can access easily.

Build Authorization Requests With the Assent Compliance Platform

Companies need accurate, up-to-date information from their supply chain in order to create authorization requests. Supply chain due diligence automation can help you acquire the data to respond to these requirements cost-efficiently and accurately, allowing you to build comprehensive dossiers. The best-in-class Assent Compliance Platform can help you acquire this data, with a range of features that streamline due diligence and centralize all data under one secure roof.

To learn how our solutions can streamline your supply chain data collection and reporting processes, contact our experts today.

Dr. Raj Takhar
Regulatory & Sustainability Expert, Product Sustainability

Raj helps companies meet their product compliance challenges in an ever-changing regulatory landscape. He specializes in product compliance, chemical reporting, and program implementation in Europe.

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