Update on PPP Registration in GB
Update on PPP Registration in GB
Kerona Scientific was delighted to host Darren Flynn from the UK Chemical Regulation Division (CRD) as a speaker at the Dublin Plant Protection Product Symposium in November 2023. Darren gave a detailed update on Plant Protection Product (PPP) Registration in GB, including information on the approval of new active substances, the authorisation of biopesticides, the active substance renewal programme (ASRP), and the reactive reviews. Although the UK has left the EU in 2020, CRD continue to participate in projects with global regulatory authorities, e.g. OECD expert groups and maintains engagement with JMPR and EPPO. HSE is also exploring the possibility to work collaboratively with other regulatory authorities for the evaluation of new active substances and renewals.
The GB active substance authorisation process looks very similar to the EU process, as there has been a ‘lift and shift’ of Regulation (EC) No. 1107/2009. However, some functions previously provided by EU were re-patriated, e.g. the publication and public consultation, HSE conclusions of the authority/decision documents, and the decision-making process which involves DEFRA and is done within the UK/Devolved Governments. The new estimate for the whole process (application to approval) is now 2.5 – 3 years, instead of the 12 – 18 months suggested pre-Brexit. Even though the timeline has been extended compared to the initial estimate, this system allows for parallel processing of the active substance, the representative product, MRLs and harmonised C&L. On top of that, additional product applications can start being evaluated towards the end of the active substance approval process, when the endpoints are assured, and applicants do not have to wait for the approval of the active.
Regarding GB active substance renewal, the process proved to be more complex than originally anticipated, therefore CRD has been working closely with DEFRA and Devolved Governments to find a solution. To be able to deal with the future renewal programme demands, HSE is expanding their resources and meanwhile, approvals are being maintained. Expiry dates for 179 active substances due to expire before April 2025 were extended by up to 5 years in April 2023, with a further extension exercise being planned for early 2024, as required under Art 17(1).
The CRD is also focusing on reactive reviews of active substance according to Article 21 of Regulation (EC) 2009/1107, which states that approvals can be reviewed at any time, when there are indications that the substance no longer satisfies the approval criteria. So far, CRD has been focussing mainly on EU decisions, as these should be considered for NI anyway. However, new knowledge from any comparable regulator will be considered going forward, including positive assessments to support a similar decision in GB. Updated information in reactive reviews in GB can be found on the HSE website: https://www.hse.gov.uk/pesticides/pesticides-registration/active-substances/reviews.htm
Darren finished his presentation with important updates on both PPP and MRLs. The permission to import, place on the market and use seed treated with PPPs not authorised in GB is allowed until 31 December 2023. Similarly, the permits for parallel trade products have been withdrawn with final sale date of 30 June 2023 and use date of 30 June 2024. However, due to industry concerns, a new Statutory Instrument came into force on the 31st of December 2023, allowing treated seed to be imported, marketed and used until 1 July 2027.
(https://www.legislation.gov.uk/uksi/2023/1321/regulation/3/made#regulation-3-2)
This will subsequently give time to manufacturers to obtain GB authorisations of PPPs for use as seed treatments. In additions, holders of parallel trade permits valid as of 31 December 2022 will be able to apply to have their permits re-instated for two years, to allow time for applicants to seek product authorisations. It is important to remember that applications are required between 1 January and 1 April 2024 and the re-instated permits will be issued by 30 June 2024. Lastly, regarding NI MRLs, GB MRLs apply to goods moved from GB to NI under the NI retail movement scheme, for all other goods moved from GB to NI, the EU MRLs apply, and EU MRLs apply to crops grown in NI. Detailed information can be found on the HSE website: https://www.hse.gov.uk/pesticides/mrls/mrls-in-northern-ireland.htm
A copy of the slides from the Dublin PPP Symposium is available from the publications page at https://kerona.ie/product/dublin-ppp-symposium-2023-speakers-presentations/
If you need regulatory support with PPPs in the UK/EU, please contact the experts in Kerona Scientific at info@kerona.ie