The Impact of a ‘no-deal’ Brexit on the Regulation of Plant Protection Products in the UK

With the United Kingdom due to leave the European Union on 29th March 2019, businesses concerned with the registration of plant protection products must now look to see how they are affected if a withdrawal agreement is not in-place after exit day.

The terms of the UK’s departure from the EU are still unclear, meaning continued uncertainty for businesses. If a withdrawal agreement can be reached between the UK and EU there will be an implementation period during which the UK will comply with EU laws, and data sharing between the EU and the UK is expected to continue. However, with little time remaining there is an increasing possibility that an agreement will not be reached, forcing a ‘no-deal’ scenario.

With respect to plant protection products (PPPs), in a ‘no-deal’ scenario, the current EU regulatory regime will be converted into UK law and will remain very similar to the existing EU regime. When this happens, PPP applications for products intended for the UK market will need to comply with the new UK regulatory framework and must be submitted to the UK authority (Health and Safety Executive, HSE).

The UK government and HSE have issued guidance for business which outlines plans for the UK regulation of PPPs in a no-deal scenario and the necessary measures businesses will need to take in order to be prepared.[1], [2]

 

Maintaining continued access to the UK market under a ‘no-deal’ Brexit

Under a ‘no-deal’ scenario, applicants, authorisation holders, and approval holders will be able to be based anywhere in the world under the new UK PPP framework, as like the current EU framework. However, depending on the date of application approvals and authorisations, a number of different scenarios may be applicable:

• All current active substance approvals, PPP authorisations, and MRLs in place on the 29th March 2019 would remain valid in the UK and the EU after the exit date.
• Applications started before the 29th March 2019 but not yet approved, where the UK is acting as the zonal RMS, after exit day will be progressed to a UK only conclusion.
• Applications started before the 29th March 2019 but not yet approved, where the UK is a concerned MS, after exit day the UK authority (HSE) may need to consider the application as a standalone UK application.
• All PPP applications made after the 29th March 2019 will need to be submitted separately to the EU and/or as a standalone application made to the UK, depending on the intended product market.

Following a ‘no-deal’ Brexit, the UK would make its own decisions on active substance approvals and PPP authorisations, and will use its own assessments to set maximum residue levels (MRLs). Business will need to bear in mind that although the new UK system would remain as close as possible to the current EU system, some differences may exist and will become more prevalent over time as the two systems diverge.

Additionally, the UK government intends to develop a UK-wide active substance renewals programme after departure from the EU. To allow time for the necessary evaluations to be carried out, the expiry dates of any active substances and associated products due to expire within 3 years after the EU exit day will be extended by another 3 years.

 

Maintaining continued access to the EU market under a ‘no-deal’ Brexit

The UK will become a ‘third country’ meaning it is no longer a member of the EU. This will have the following implications for existing PPP activities concerning the UK:

• For ongoing applications started before 29th March 2019 but not approved before exit day, and are currently being assessed by the UK, applicants are advised to consider a change of rapporteur or evaluating member state if the product is intended for the EU market.

The rules on PPPs outlined by the European Commission (EC) following the withdrawal of the UK from the EU can be found here: https://ec.europa.eu/info/sites/info/files/file_import/plant_protection_products_en.pdf

 

Enviresearch is here to help

During this period of uncertainty, Enviresearch can offer expert regulatory advice and support to minimise the impact of Brexit on your business. We will continue to provide assistance with the preparation of active substance and plant protection product dossiers to support pesticide registrations under the existing EU framework, alongside the new UK national system if put in place. 

For further information on the impact Brexit may have on REACH, BPR and CLP view our other recent articles here: https://www.enviresearch.com/brexit.  You can contact our expert consultants to discuss your Brexit speicifc and general enquiries at This email address is being protected from spambots. You need JavaScript enabled to view it..

 

References

[1] https://www.gov.uk/government/publications/regulating-pesticides-if-theres-no-brexit-deal/regulating-pesticides-if-theres-no-brexit-deal
[2] http://www.hse.gov.uk/brexit/regulating-pesticides-no-deal.htm