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Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment Etc.) (EU Exit) Regulations 2019

Synopsis

This regulation may apply a UK-only system under the Biocidal Products Regulation. This regime would only be introduced if the UK leaves the EU without a deal or with a deal that does not involve continued cooperation with ECHA.

All active substance and product approvals prior to Exit Day would be transferred to the UK regime. Ultimately biocides and biocidal products would need to be included on an approved UK list to place them on the market.

 
 
 

Summary

The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 will amend the Biocidal Products Regulation (EU) No 528/2012 in the event the UK leaves the EU without a deal.

The 2019 regulations would come into force on Exit Day.

What would be amended?

No deal Brexit and the Biocidal Products Regime

In the event of a no deal Brexit, the HSE would establish a UK biocidal product approval system.

All active substance and product approvals prior to Exit Day would be transferred to the UK regime. Existing approvals would remain valid until the expiry date(s) set. Information supporting this authorisation would need to be submitted to the HSE within two years of Exit Day.

Applications for UK Authorisation

New or expired biocidal products and active substances would need a UK-specific approval to supply them to the UK market. This would require an application to be submitted to the HSE. Information required would be the same as submitted to ECHA.

Applications for UK authorisation would need to be submitted by UK established companies.

Products and substances subject to ongoing applications on Exit Day could be transferred to the HSE to obtain national authorisation.

EU Authorisations

Authorisations to supply active substances and biocidal products in the EU, EEA and Switzerland would need to be submitted via ECHA.

UK List of Approved Active Substance Suppliers

An approved active substance supplier list (mirroring the ‘Article 95’ list under the Biocidal Products Regulation) would be established for the UK on Exit Day.

All existing entries from the EU list would be transferred to this UK list initially. However, all suppliers would need to submit substance information to the HSE to remain on it after two years following Exit Day.

Fees

The Health and Safety and Nuclear (Fees) Regulations 2016 will be amended to add fees payable for applications under the Biocidal Products Regulation.

GUIDANCE

The HSE has published no-deal scenario guidance for the Biocidal Products regime.

 

 

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