Biocides product and active substance fact sheets
HSE have published a series of fact sheets for businesses that want to gain, or maintain, access to the GB market after 31 December 2020.
The fact sheets provide information which will be useful to those who may be impacted by the changes, such as:
- Current UK biocides authorisation holders
- New and ongoing product authorisation applications
- Companies supporting active substance(s) for approval
- Article 95 suppliers
Each fact sheet provides guidance on what action you need to take and when you need to do it.
What are the requirements of the Biocidal Products Regulation in Great Britain (GB BPR)?
The existing EU Biocidal Products Regulation (EU BPR) has been copied into GB law and amended to enable it to operate effectively in GB.
This means that most aspects of EU BPR will continue in the same way under the new GB Biocidal Products Regulation (GB BPR) that came into force at 11pm on 31 December 2020.
HSE (GB)'s biocides website has been updated and contains details of the GB BPR requirements for biocidal products in GB.
HSE (GB)'s updated Brexit guidance highlights the main differences between EU BPR and GB BPR as well as the things that are unchanged.
GB application forms and IT systems
HSE can no longer access data and information in the EU databases and IT systems.
Applications for GB product authorisation, active substance approval and GB Article 95 suppliers should be made direct to HSE (not via R4BP) using our application forms and systems.
Details of each of the application processes including application forms and supporting documents can be found on the following sections of HSE's website:
- GB product authorisation - www.hse.gov.uk
- GB active substance approval - www.hse.gov.uk
- GB Article 95 suppliers - www.hse.gov.uk
A list of all the GB BPR application forms and templates can be found on HSE (GB)'s resources webpage.
HSE will accept the EU version of the applicable supporting document e.g. the draft Product Assessment Report (PAR), Summary of Product Characteristics (SPC) (including meta SPC) and active substance draft Risk Assessment Report (RAR) for applications that need to be resubmitted in GB.
HSE continues to charge fees for processing and evaluating applications.
The fee levels are the same under GB BPR as they were under EU BPR.
HSE will not charge for receiving and handling the resubmission of data or applications due to loss of access to EU databases and IT systems. Fees to evaluate the resubmitted data or application will be applied as normal.
What are the requirements of the Biocidal Products Regulation in Northern Ireland?
The EU Biocidal Products Regulation (EU BPR) is still applicable in Northern Ireland.
Authorisations previously granted for the United Kingdom are still valid in Northern Ireland.
Authorisation holders must:
- continue to comply with the terms and conditions for the biocidal products as outlined in their certificate of authorisation and
- be established in the EU or Northern Ireland
New Union authorisations granted under EU BPR by the EU Commission are applicable in Northern Ireland (but not Great Britain).
Pending Union applications submitted under EU BPR are still valid in Northern Ireland.
For all other pending product authorisation application types (e.g. National Authorisation, Mutual Recognition etc.) please contact HSE at NI.Biocides@hse.gov.uk to confirm you wish to proceed with the application for access to the market in Northern Ireland.
All biocidal products supplied in Northern Ireland must comply with the EU BPR e.g.
- EU BPR Article 95 supplier
- Advertisement requirements
- Record keeping requirements
You should also check your duties to classify, label and notify poison centres etc. under general chemical laws (such as the Classification, Labelling and Packaging of Substances and Mixtures Regulation).
Businesses who want to supply a biocidal product in Northern Ireland should contact HSE at NI.Biocides@hse.gov.uk until website guidance is available.
Stakeholder webinar recording available
HSE and the Department for Environment, Food and Rural Affairs (Defra) hosted a virtual stakeholder event on 20 January.
The webinar covered actions organisations need to take to keep their business moving now that the UK Transition period has ended and how the new GB regulatory regimes for chemicals impacts their work.
You can watch the session on biocides at the link below: