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07 March 2019
What do the draft regulations say?
Decision-making powers transferred to Secretary of State
Prompt and efficient decisions
Health and Safety Executive to replace ECHA
Fees and charges
Grandfathering of BPR authorisations
UK chemicals strategy?
Draft regulations have been laid before Parliament to ensure that regimes governing biocidal products, hazardous chemicals and chemical classification can continue to operate after Brexit.
Further legislation to ensure that EU rules on chemicals, biocidal products and genetically modified organisms will continue to operate under UK law after Brexit have been laid before Parliament. It follows hot on the heels of similar legislation creating a 'UK REACH' and a UK chemicals agency (more details to be found here) and there are some common themes, as we explore in this note. The draft Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 were laid before Parliament on 21 January 2019. As with the draft regulations creating a UK REACH, these rules will only come into force on exit day in the absence of an EU-UK deal, but whether or not a deal is reached before or after 29 March 2019, the draft regulations provide us with an insight into the approach government is taking to the regulation of chemicals after Brexit.
The draft regulations address the following areas of EU chemicals regulation:
The draft regulations also cover the regime for the control of genetically modified organisms, although that is not the subject of this note.
Although each particular regime covered by the draft regulations requires specific amendments in order to function appropriately after Brexit, there are a number of common themes. Many of these common themes are also present in the draft regulations creating a UK REACH and it is worth comparing our comments here with the more detailed analysis in our UK REACH article. The main points to note are as follows:
Similarly to the proposed functioning of 'UK REACH', under the draft regulations the decision-making powers previously held by the European Commission will be transferred to the Secretary of State (with the consent of devolved administrations as appropriate). A good example is the approval, or non-approval, of an active substance under the BPR. Although this mirrors the Secretary of State's role under other regulatory regimes, it raises an obvious question about whether such decisions will become more politicised, and the parallel regimes create a significant potential for divergence between UK and EU decisions.
The current EU regimes make use of the EU's delegated decision-making arrangements in order to run efficiently and provide legal certainty to businesses. This allows the regulatory regime to keep pace with scientific understanding, without being held back by the much slower timescales involved in amending the law. To resolve this at UK level, the government has provided ministers with the ability to agree to a recommendation and then issue a subsequent decision to this effect, without the need to pass statutory instruments through Parliament. The idea is that this approach will enable the UK to more easily follow the volume and pace of scientific and technical changes. Whether this is palatable to the UK Parliament remains to be seen.
Where the European Chemicals Agency ('ECHA') previously undertook functions acting as the 'Agency' on behalf of the UK, these functions are to be transferred to the Health and Safety Executive ('HSE'). HSE's functions will include undertaking technical equivalence assessments under the amended BPR and dealing with notifications made by manufacturers and importers under the amended CLP Regulation.
At face value, it makes sense to pass these roles to the HSE, as the HSE will also be operating as the UK Agency under UK REACH. However, given the large amount of work the HSE will be required to carry out when it is required to deal with the re-submission of large amounts of data under a 'UK REACH', this move only increases the concerns about the resourcing pressures for the HSE. As with UK REACH, there are also questions over the potential for significant divergence between the decisions of the EU and the UK, with two separate agencies coming to different conclusions on near-identical facts under near-identical regulatory regimes.
There is currently a system of variable fees and charges depending on the size of the organisation involved under most EU chemicals regulations. However, under the draft regulations it is proposed that HSE will impose fees proportionate to the actual cost of its interventions. This is consistent with the well-established policy of HSE setting fees at a level whereby they are able to recover the full costs of its regulatory activities.
Once the UK has left the EU, the HSE will need to evaluate applications for national authorisations and make decisions on behalf of the UK.
Biocidal product authorisations and active substance approvals that were in place before exit day will continue to be valid after exit until their normal expiry date (provided that, for product authorisations, the company is established within the UK within 12 months of exit day).
Where applications were made to HSE before exit day but no decision on authorisation or approval has been taken by exit day, provision is made for the data supporting the application to be resubmitted to HSE within defined deadlines. This is necessary so that HSE can continue to process the applications and take a UK decision on authorisation or approval after access to the EU databases containing the data supporting applications is lost. Where such deadlines are not met, applications would be cancelled and affected products would need to be removed from the market (subject to a period of grace for disposal of existing stocks).
These draft regulations are largely consistent with previous implementing legislation published ahead of Brexit. They attempt (as far as possible) to preserve the status quo. As the UK looks to chart its own course after Brexit, its strategy for the future of chemicals regulation is yet to be seen. This strategy has been promised by DEFRA as one component of its 25 Year Environment Plan and, while we don't yet have a date for the strategy, the broad expectation is that it will appear this year.
For further information on this topic please contact Simon Tilling at Burges Salmon LLP by telephone (+44 117 939 2000) or email (email@example.com). The Burges Salmon LLP website can be accessed at www.burges-salmon.com.
This article has been reproduced in its original format from Lexology – www.Lexology.com.
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