Q&As

The UKs withdrawal from the EU

BPR

I understand that the Commission has also published information on the impact of the United Kingdom withdrawal on companies with obligations under the Biocidal Product Regulation (BPR). Where can I find that information?

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.

My United Kingdom-based company is the holder of a product authorisation in an EU Member State, EEA or Switzerland or of a Union authorisation under the BPR. What effect does the end of the transition period have on our authorisation?

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).

What is the effect of the United Kingdom withdrawal with regard to active substances that were originally evaluated by the United Kingdom and subsequently approved by the European Commission or an EU Member State?

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.

Can my United Kingdom-based company submit requests for active substance approval or inclusion of a substance on Annex I?

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.

Does the substance or product-specific data owned by my United Kingdom-based company remain protected by the data protection rules of the BPR?

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

My EU based company benefits from an authorisation issued by an EU Member State prior to the United Kingdom withdrawal date on the basis of the recognition of a United Kingdom authorisation. Is my authorisation affected by the United Kingdom withdrawal?

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.

After the end of the transitional period, will an EU Member State still be able to issue a national biocidal product authorisation on the basis of the mutual recognition of a UK authorisation granted before the UK withdrawal?

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.

My company needs to submit an application for renewal of an approval of our active substance for which the United Kingdom acted as the evaluating Competent Authority (eCA) during the first approval procedure. Can my company choose another competent authority as eCA?

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.

My company needs to apply for a change or renewal of a product authorisation granted in a mutual recognition procedure in which the United Kingdom acted as the reference Member State (refMS). Can my company choose another competent authority as refMS?

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.

Do my United Kingdom-based company’s accounts in R4BP 3 remain accessible, or will ECHA delete them?

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).

What is the effect of the withdrawal of the United Kingdom on ongoing applications for processes in parallel (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) for which the United Kingdom was the reference Member State?

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.

In case an application for mutual recognition in parallel or for Union authorisation is terminated and a new application has to be submitted, how would this affect the legal status of the existing products on the market with regard to Article 89(2) and (3) of the BPR?

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.

My company notified to a number of Member States, under Article 27(1) of the BPR, a biocidal product authorised in the United Kingdom via the simplified procedure. What effect does the end of the transition period have on these notifications?

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.