Brexit: Implications for business
Following the end of the Transition Period on 31 December 2020, Great Britain is no longer part of the EU scheme for regulating biocides.
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 stand-alone regime – the GB Biocidal Products Regulation (GB BPR) came into force at 11pm on 31 December 2020.
This page highlights the main differences between EU BPR and GB BPR as well as the things that are unchanged. It also provides clear guidance on what action you need to take and when you need to do it. We advise you to check back regularly and subscribe for free email updates.
This page addresses the situation in GB only. Find out about the specific implications for Northern Ireland.
Similarities between EU BPR and GB BPR
Active substance approvals/product authorisations
Existing active substance approvals and UK product authorisations (including essential use authorisations and R&D permits) are valid in GB. You will need to ensure your company has a base in the UK and you may need to submit supporting data or other information to HSE (that has previously been submitted to the European Chemicals Agency (ECHA)) within prescribed timescales. This will be the same information as was previously submitted as HSE can no longer access the EU databases and IT systems where this information was held. HSE will not charge additional fees for receiving this data/information, however we will continue to charge fees for evaluating it. You will need to continue to meet any existing conditions such as post-authorisation requirements in GB as well as in the EU, the European Economic Area (EEA) and Switzerland.
- Active substances that were already in the EU Review Programme on 31 December 2020 are intended to be included in the GB Review Programme. For your active substance to be evaluated under the Gb Review Programme, you will need to submit your full application to HSE within prescribed timescales. Further information can be found in our fact sheets.
- Where an active substance / product type combination had previously been considered to be outside the scope of the BPR, but new guidance or an Article 3(3) decision is published which confirms it is within scope, you will continue to be able to submit a declaration of interest in notifying the active substance / product type combination for review.
Declarations of interest that were considered compliant under the EU Review Regulation on or before 31 December 2020 are considered compliant under the GB Review Regulation.
Time periods for submitting declarations of interest that had not expired on or before 31 December 2020 remain valid under the GB Review Regulation.
Further information on submitting declarations of interest can be found in our fact sheets.
- Where an active substance is redefined during a review, or the original participant withdraws their support, you will continue to be able to make a notification to take over support of that active substance / product type combination.
Notifications that were considered compliant under the EU Review Regulation on or before 31 December 2020 are considered compliant under the GB Review Regulation. To remain compliant, you will need to resubmit your notification to HSE within prescribed timescales.
Open invitations to notify that had not expired on or before 31 December 2020 remain valid under the GB Review Regulation and the same deadline to notify applies.
Further information on submitting notifications can be found in our fact sheets.
A GB version of the Article 95 List has been established and operates in the same way as the EU Article 95 List. Companies that were already on the EU list on 31 December 2020 are included in the GB list. To remain on the list, you will need to submit supporting information to HSE within prescribed timescales. This will be the same information as was previously submitted to ECHA, for example, an active substance dossier or a letter of access. Companies submitting a letter of access will only be able to remain on the GB Article 95 List if the data owner(s) have submitted the relevant data to HSE within the prescribed timescales. All companies will also have to ensure they are established in the UK.
Further information on how to remain on the GB Article 95 List can be found in our fact sheets.
HSE continues to charge fees for processing applications and the levels are the same under GB BPR as they were under EU BPR. If you want to have a biocidal product authorised in both the EU (including the EEA and Switzerland) and GB, you will have to apply separately to HSE and ECHA. This means you will have to pay both sets of fees.
Under GB BPR there are some new activities for HSE to carry out that it will need to charge for. These are activities that were done by ECHA under EU BPR, such as technical equivalence assessments, and were already charged for by ECHA.
There will be no fees for the resubmission of data or applications due to loss of access to EU databases and IT systems, however fees will still apply to the evaluation work that HSE carries out on these applications.
The same data requirements that you are used to for EU BPR also apply to GB BPR, including UK specific national requirements. You can continue to use the same format for your applications as you use in the EU, the EEA and Switzerland. Where there is no GB-specific guidance, HSE will use relevant technical guidance for EU BPR, as the two sets of legislation are very similar, but decisions taken using this guidance will apply only in GB. Future decisions taken in the EU, the EEA and Switzerland will not automatically apply in GB.
The data protection periods applied to data supporting active substance approvals and product authorisations granted under GB BPR will be the same as those under EU BPR. Data which has already been granted protection under EU BPR will not gain any additional protection from supporting active substance approvals or product authorisations under GB BPR.
Food and feed derogations
Existing food and feed derogations remain valid in GB.
Differences between EU BPR and GB BPR
GB will take all its own decisions and will no longer participate in any of the EU decision making or the work sharing between EU Member States, the EEA and Switzerland. GB will no longer have access to EU systems so cannot gain access to information previously submitted under those systems, unless publicly available, or share information in that way with EU Member States, the EEA and Switzerland.
GB will have the right to take different decisions to the EU, the EEA and Switzerland and will develop its own Review Programme of existing active substances. GB will no longer be participating in the EU Review Programme but may take into account evaluations done by other regulators, including the EU, the EEA and Switzerland. Where this is considered appropriate, it will need to be demonstrated that those regulators are evaluating to the same standards as GB.
For active substance approval in GB you will need to submit a stand-alone GB application - active substances. HSE cannot accept invitations to become the evaluating Competent Authority (eCA) for active substances on behalf of the EU, the EEA and Switzerland.
Partial evaluations done by HSE under EU BPR prior to 01 January 2021 are considered valid under GB BPR and will not be restarted. Evaluation of applications that were pending on 31 December 2020 will continue under GB BPR from where we left off, once the application has been resubmitted.
HSE will continue to consider any adverse data brought to its attention and take appropriate action.
Active substance approvals which have been granted under EU BPR prior to 01 January 2021 will be considered approved under GB BPR with the same terms and conditions / restrictions. Consequently, GB may still be able to rely on assessments of Technical Equivalence which have been undertaken by ECHA prior to 01 January 2021. However, this would be dependent on the degree and quality of information which is made available to HSE.
Applications for new technical equivalence assessments in GB after 31 December 2020 will be dependent on the level of information relating to the reference source which is available to HSE to make a decision.
Further guidance on the assessment of technical equivalence after 31 December 2020 will be provided in due course.
For product authorisation in GB you will need to submit a stand-alone GB application - product authorisation (eg for a GB national authorisation or GB simplified authorisation).
HSE cannot accept:
- invitations to become the evaluating Competent Authority (eCA) for Union authorisation or simplified authorisation on behalf of the EU, the EEA and Switzerland
- applications as the reference Member State (rMS) for mutual recognition applications within the EU, the EEA and Switzerland
- applications for mutual recognition of authorisations in EU Member States (including the EEA and Switzerland) as a ‘concerned Member State’ – it is not possible for GB to mutually recognise a product authorisation granted by a country in the EU, the EEA or Switzerland after 31 December 2020
- applications for simplified notification of authorisations valid in EU Member States (including the EEA and Switzerland) – it is not possible for a product granted simplified authorisation by a country in the EU, the EEA or Switzerland after 31 December 2020, to be made available on the market in GB without a separate GB simplified authorisation
For EU authorisation after 31 December 2020 you are advised to contact another country in the EU, the EEA or Switzerland. A list of Competent Authorities and their contact details can be found on the ECHA website . If you would like to contact ECHA a webform is available.
Pending product applications that are not completed on or before 31 December 2020 will need to be resubmitted to HSE. Partial evaluations done by HSE under EU BPR prior to 01 January 2021 are considered valid under GB BPR and will not be restarted. Evaluation of applications that were pending on 31 December 2020 will continue under GB BPR from where we left off, once the application is resubmitted. Further information on resubmitting pending product applications to HSE can be found in our fact sheets.