These Regulations apply to those with an interest in the biocidal authorisation application process, particularly applicants.
When did it change?
These Regulations come into force on 31 December 2022.
What does it mean?
This Statutory Instrument addresses deficiencies in retained European Union (EU) law relating to biocidal products arising from the withdrawal of the UK from the European Union (EU Exit). It extends the legal deadlines that are in place for processing biocidal product authorisation applications by the HSE acting as competent authority.
The Instrument aims to ensure there is sufficient time to process applications and that biocidal products can remain legally on the market in Great Britain as intended by the legislative framework.
There are various stages to the process of considering applications such as informing the applicant of fees (invoicing), validating the application (following initial checks) and evaluating the application in order to decide whether to grant an authorisation. There are legal deadlines in place for each part of this process which the HSE or the applicant must meet.
Prior to the GB BPR (Great Britain Biocidal Products Regulation), biocidal products were able to be placed on the market under pre-existing national law. Article 89 of GB BPR permits biocidal products, which are currently allowed to be made available on the market under that pre-existing national law, to transition to authorisation under GB BPR. A period of three years is currently permitted for pre-existing national law to apply from the date of approval of the last active substance in that product. This timeframe would ordinarily allow sufficient time to process an application for authorisation of a biocidal product under GB BPR.
This Instrument puts in place a temporary extension for a period of five years to the legal deadlines by which affected biocidal product authorisation applications are required to be processed by HSE. Where biocidal products were previously authorised under pre-existing national law, the Instrument ensures they can continue to be placed on the market and used until they are authorised under GB BPR rather than being required to be removed from the market once three years has elapsed from when the last active substance in that biocidal product was approved.
The extension applies to the following classes of application:
Applications previously submitted to HSE prior to IP completion day and then resubmitted under transitional provisions in the GB BPR (inserted by the EU Exit statutory instruments) after IP completion day.
Applications submitted to HSE up to four years after IP completion day, where processing these applications relies on historical information to which HSE has lost access.
Once the 5-year deadline extensions lapse, the normal deadlines in GB BPR will apply and processing will return to the usual timeframes.
What’s changed?
These Regulations amend retained EU law relating to the applications for authorisation of biocidal products. In particular, they impose new deadlines within which certain actions must be taken by the competent authority in relation to an application for the authorisation of a biocidal product.
The Instrument also amends Article 89 of the Great Britain Biocidal Products Regulation (GB BPR) to ensure that where biocidal products are allowed to remain on the market and be used under pre-existing national law while they await authorisation under GB BPR, they may remain on the market and be used until such time they have been authorised under GB BPR in accordance with the extended deadlines.
The Instrument also inserts a new transitional arrangement into GB BPR – Article 95FA. This Article makes transitional provision for applications made to the UK competent authority under Article 4a of Commission Implementing Regulation (EU) No 414/2013 before Implementation Period (IP) completion day and in respect of which a decision was not made before IP completion day. Such applications must be resubmitted to the competent authority by 31 January 2023, in order to be considered for authorisation under GB BPR.
The Instrument is formally prospective but will have some retrospective effect – that is, this temporary future change will have some effect on past arrangements. Stakeholders with an interest in the biocidal authorisation application process, particularly applicants, would not have reasonably expected the legal deadlines to be extended after applications had been submitted.
See below for the full document: