A change in governance usually results in updates to legislation; which in turn impacts on business and the broader community - often bringing with it an administrative burden. In these instances, preparation is key. The sooner you're informed about a relevant legislative update, the sooner you can align your business processes and staffing to accommodate it. Let's take a look at a recent Brexit example to see how knowledge of your applicable legislation is critical to success - especially when legislation changes.
In preparing for all eventualities, including a ‘no-deal’ Brexit, the UK government has published a Guidance document setting out information to enable producers, registers, importers and exporters of chemicals to make informed decisions in the event of a ‘no-deal’ Brexit.
The main piece of legislation regulating the UK chemical industry is the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), which is implemented by the European Chemicals Agency (ECHA). REACH requires EU companies to register chemicals with ECHA before placing them on the market.
Should the UK leave the EU without a deal, companies with substances registered under REACH would no longer be able to sell into the European Economic Area (EEA) market without transferring their registrations to an EEA-based organisation.
The Government has stated that it will establish a UK regulatory framework and build domestic capacity to deliver the functions currently performed by ECHA. The domestic legislation will aim at preserving REACH as far as possible and allow the UK Government to monitor and evaluate chemicals in the UK. The Health and Safety Executive (HSE) would act as the lead UK regulatory authority from the day the UK leaves the EU. In terms of the Guidance document, UK Companies registered with REACH would no longer be able to sell into the EEA market without transferring their registrations to an EEA-based organisation, and UK downstream users, currently importing chemicals from an EEA country, would face new registration requirements.
Ensuring continued access to UK market and maintaining existing standards for human health and the environment
In order to ensure continued access to the UK market and maintain existing standards of protection for human health and the environment, the UK Government have outlined its intention to:
- transfer existing REACH registrations held by UK-based companies directly to the UK’s replacement for REACH
- set up a transitional "light-touch" notification process for UK companies importing chemicals from the EEA before the UK leaves the EU that do not hold a REACH registration
- carry into the UK system all existing authorisations to continue using higher-risk chemicals held by UK companies.
What UK companies need to do
Companies with existing EU REACH registrations would have to validate their existing registration with the HSE by opening an account on the UK IT system (currently being tested) and provide information on their existing registration within 60 days of the UK leaving the EU. These companies would have two years from the day the UK leaves the EU to provide the HSE with the full data package that supported their original EU registration and is held on the ECHA IT system. Companies wishing to maintain EEA market access would need to refer to guidance on the ECHA website. As an example, the Guidance document states that existing UK registrants would need to transfer their registrations to an appropriate EEA-based entity (such as an affiliate or an Only Representative (OR)) or develop new working relationships with their EEA customers. This would require action before the UK leaves the EU.
Companies wishing to register new chemicals for the EEA market after the UK leaves the EU would need to register those with ECHA as they do now, but would need to do so via their EU customers or an OR. Further guidance on how to do this can be found on the ECHA website.
Companies that imported chemicals from the EEA before the UK leaves the EU without an EU REACH registration would need to notify the UK authority and provide data on the chemicals within 180 days of the UK leaving the EU. This would be an interim arrangement for those importers who would need to move to full registration at a later date following a review of this approach. These companies would be responsible for identifying appropriate risk management measures and recommending them to their customers.
Companies wanting to place new chemicals on both the EEA and UK markets would have to make a registration to ECHA and a registration to the UK. The information and data package needed would be the same for both.
Please note: This correspondence is not intended to be, and does not constitute, legal advice or opinion.
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