On 13 September 2017, the Commission published a “notice to business operators” on the impact of the United Kingdom withdrawal on the policy webpage of the Directorate General for Health and Food Safety. Simultaneously, it released a set of Q&As to be found on the same webpage. They provide similar information as that to be found on the ECHA webpages. The Commission updated its information on 23 October 2018. In addition, on 17 June 2020, the Commission published a notice to stakeholders on biocidal products.

• Commission questions and answers on biocides 
• Commission notice to stakeholders on biocidal products

According to Article 3 of the BPR, an authorisation holder must be established within the European Union. By virtue of the EEA Agreement as well as the Mutual Recognition Agreement with Switzerland, an authorisation holder can also be established in Iceland, Liechtenstein, Norway or Switzerland. Companies established in United Kingdom, except for Northern Ireland, cannot be holders of such authorisations. 

Companies established in Northern Ireland can maintain their product authorisations in EU Member States or Union authorisations, as per the IE/NI Protocol (see Q&As 1703-1710).

The United Kingdom withdrawal does not have any effect to the validity of the approval of these active substances. The approval of these active substances is a decision taken at EU level.

Yes, but the application will have to be submitted in an EU Member State (or an EEA country or Switzerland). Contrary to the case of a product authorisation, applicants for the approval of an active substance or Annex I inclusion are not "holders"/"owners" of an approval and do not need to be established in the EU/EEA/Switzerland. Third country entities can undertake such submissions. However, being located in an EU Member State (or an EEA country or Switzerland) or having a local representative may facilitate the dialogue with the various bodies during the processing of the applications.

The data sharing mechanism under Articles 62 and 63 of the BPR is still be available to such companies, for the purposes of the BPR; for example, where a United Kingdom-based company intends to submit an application for active substance approval – and it requires vertebrate data for its application.

In this connection, it should be stressed that it is a legal obligation for companies to make an inquiry to the Agency in the case of vertebrate data (see Article 62(2)(a) of the BPR).

Yes, but the application has to be submitted to a Competent Authority in an EU Member State (or an EEA country or Switzerland). Applicants for the approval of an active substance, Annex I inclusion or technical equivalence do not need to be established in the EU therefore third country entities can apply.

Yes. Data protection applies to all information submitted for the purposes of the BPR or its predecessor, the Biocidal Products Directive.

The BPR does not set any specific requirement regarding the location of the manufacturing site(s) of active substances or biocidal products. Therefore, manufacturing can take place in so-called “third countries”, including the United Kingdom. You do not need to take any action to continue complying with the BPR. However, shipments to the EU/EEA/Switzerland from the UK of this active substance/biocidal product are importations which has consequences from the viewpoint of other sectorial legislations (e.g. the PIC Regulation, customs).

In Northern Ireland (NI), the BPR Regulation continues to apply. This means that shipments to the EU/EEA/Switzerland of active substances/biocidal products from NI are not treated as importations for the purposes of the BPR Regulation. Please refer to Q&As 1703-1710 for further details.

The BPR does not set any specific requirement regarding the location of the manufacturing site(s) of treated articles, which can be manufactured in third countries. Treated articles manufactured in third countries can be placed on the EU/EEA/Switzerland market if they meet the conditions of the BPR, in particular Articles 58 and 94. However, shipments to the EU/EEA/Switzerland of this treated article from the UK are importations, which has consequences from the viewpoint of other sectorial legislations (e.g. customs).

In Northern Ireland (NI), the BPR Regulation continues to apply. This means that shipments to the EU/EEA/Switzerland of treated articles from NI will not be treated as importations for the purposes of the BPR Regulation. Please refer to Q&As 1703-1710 for further details.

Any treated article placed on the EU/EEA market is subject to the provisions of the BPR, in particular Articles 58 and 94. Shipments from the United Kingdom (Great Britain) to the EU of a treated article are considered as an import and, consequently, placing on the market of such treated article. If the treated article was placed on the United Kingdom market before the end of the transition period, it is expected to be compliant with the BPR already, and there should be no specific consequences as regards to compliance with the BPR (i.e. active substance approved in the EU/EEA, proper labelling information etc.). 

In Northern Ireland, the BPR Regulation continues to apply. This means that shipments of a treated article from Northern Ireland to the EU are not considered as an import for the purposes of the BPR Regulation. Please refer to Q&As 1703-1710 for further details.

As of the withdrawal date, the United Kingdom can no longer act as a leading authority in processes at Union level and, therefore, it can no longer be a reference MS (refMS) in above indicated processes.

For those applications which were submitted before the UK withdrawal date, the services of the European Commission and ECHA are working in a coordinated manner with EU Members States, EEA countries and Switzerland in order to try to identify new refMSs. The MSs at CA level and the coordination group will explore the possibilities to identify new refMSs.

Where it will not be possible to reach an agreement on identifying a new refMS, the pending process will be terminated.

Thus, the applicants are invited to actively try to identify a new refMS for pending sequence cases by themselves.

If the application for an above mentioned process was submitted after the UK withdrawal date it should be rejected by the relevant cMS(s). The applicant will need to find a new refMS and submit a new application. 

No. There is no such effect. The authorisation granted by each EU Member State remains valid in these EU Member States. 

In Northern Ireland, the BPR Regulation continues to apply. Please refer to Q&As 1703-1710 for further details.

No. For mutual recognitions in sequence, a concerned Member State (cMS) may proceed to grant a national product authorisation in accordance with Article 33(3) of the BPR provided that the mutual recognition takes place of a national authorisation granted in a Member State and  the applicant has chosen a new (EU-27/EEA/Switzerland) Reference Member State (RefMS).

For mutual recognitions in parallel, see Q&A 1545.

Yes, you should, as, the United Kingdom can no longer act as an eCA.

This implies that one of the EU Member States, EEA countries and Switzerland has to act as eCA. Article 13(3) of the BPR does not require that the eCA for the first approval shall be the eCA for the renewal, although it is usually recommended as a means to streamline the process. The mentioned provision requires that, when you submit your application for renewal, you shall indicate the name of the competent authority that you propose for evaluating your application for renewal and provide written confirmation that that competent authority agrees to do so.

To achieve a smooth process, the services of the European Commission have agreed with the EU Member States, EEA countries and Switzerland on the new evaluating competent authority from among the competent authorities of the EU Member States.

Yes, you should, as the United Kingdom can no longer act as a refMS.

Both the Commission Implementing Regulation (EU) No 354/2013 and the Commission Delegated Regulation (EU) No 492/2014 allow the authorisation holder to choose another refMS for the change, as well as the renewal procedure. You will, however, need to submit within the application a written confirmation that the new competent authority agrees to act as refMS.

No. Your company has rights stemming from the national product authorisation granted by the authorities of the concerned Member State. As any such decision authorising a biocidal product on a national market is a national one, the United Kingdom withdrawal from the EU does not affect the validity of your company’s product authorisation, even if your national authorisation is based on the mutual recognition of a United Kingdom authorisation.

No. Data owners granting letters of access do not need to be EU/EEA-based.

Yes, you continue to have access, as non-EU companies have access to R4BP 3. United Kingdom-based companies are able to perform the same actions allowed for other non-EU companies (e.g. technical equivalence, active substance approval submissions, applications for Annex I inclusion of active substances).

As of the withdrawal date, the United Kingdom can no longer act as a leading authority in processes at Union level and, therefore, it can no longer be a reference MS (refMS) in above indicated processes. This also applies during the transition period.

The services of the European Commission and ECHA are working in a coordinated manner with EU Members States, EEA countries and Switzerland in order to try to identify the new refMSs for those applications which were submitted before the UK withdrawal date. The MSs at CA level and the coordination group will explore the possibilities to identify new refMSs. 

If the application for an above mentioned process was submitted after the UK withdrawal date it should be rejected by the relevant cMS(s). The applicant will need to find a new refMS and submit a new application.

With the submission of the initial application assessed by the United Kingdom the applicant fulfilled its legal obligation laid down in the second subparagraph of Article 89(3) of the BPR. As a consequence, the existing products currently benefit from the provisions in Article 89(2) of the BPR provided that the applicant submitted a new application by 31 December 2020 for mutual recognition in parallel (to a new refMS of its choice and to the same Member States concerned in accordance with Article 34(1) and (2) of the BPR, respectively) or a new application for Union authorisation in accordance with Article 43(1) of the BPR.

The authorisation granted by the United Kingdom is no longer valid. Therefore, in accordance with Article 17(1) of the BPR, the products notified in the other Member States can no longer be made available on the market nor used.

United Kingdom national law applies, and you need to contact the United Kingdom authorities for further information. 

Also note that mutual recognition of a United Kingdom authorisation by EU Member States is not possible since the withdrawal date – see Q&A 1719.

In Northern Ireland, BPR continues to apply. Please see Q&A 1703-1710.

As of the withdrawal date, the United Kingdom has become a third country and can no longer act as a leading authority in processes at Union level and, therefore, it can no longer be a reference MS (refMS) in mutual recognition processes. Accordingly, you cannot apply for mutual recognition (e.g. mutual recognition of a biocidal product authorisation in accordance with Articles 33 and 34 of the BPR, renewal of product authorisations under Commission Delegated Regulation (EU) No 492/2014 or applications for minor or major changes under Commission Implementing Regulation (EU) No 354/2013) of a UK authorisation. 

If the application for an above-mentioned process was submitted after the UK withdrawal date it should be rejected by the relevant concerned Member State(S) (cMS(s)). The applicant will need to find and submit a new application to a new reference Member State, in order to obtain the authorisation.

As of the withdrawal date, the United Kingdom can no longer act as a leading authority in processes at Union level. Therefore, it can no longer be a reference MS (refMS) and cannot address the issues raised by the initiating concerned Member State (cMS). 
The only possibility to resolve the referral would be that a competent authority of an EU Member State/EEA country/Switzerland agrees to act as the new refMS.

Where it will not possible to reach an agreement on identifying a new refMS, the ongoing process will be terminated. 

Thus, the applicants are invited to proceed with the new sequence applications only when a new refMS is found by them.