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The UKs withdrawal from the EU

BPR

I understand that the Commission has also published information on the impact of the UK 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 UK 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 UK(Great Britain)-based company is the holder of a product authorisation in an EUMember State, EEA or Switzerland or of a Union authorisation under the BPR. What effect will 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. Therefore, by the end of the transition period, you will need to transfer the authorisation to a new holder established within an EUMember State or one of the aforementioned countries. You can trigger the amendment of your existing authorisation by means of an administrative change requiring prior notification before implementation (see point 3 in section 1 of Title I in the Annex to Commission Implementing Regulation (EU) No 354/2013 on changes of biocidal products).

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

What effect will the UK withdrawal have with regard to active substances that were originally evaluated by the UK and subsequently approved by the European Commission or an EU Member State?

The UK withdrawal will 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.

My non-EU/EEA/Switzerland company is listed as a supplier under Article 95 of the BPR and established outside the EU. My EU/EEA representative is established within the United Kingdom(Great Britain). What effect will the end of the transition period have on my company’s interests?

According to Article 95(1) and (2) of the BPR, substance or product suppliers listed in the Article 95 list must be established within the European Union. Therefore, you will need to appoint a new representative established within the Union (or EEA countries or Switzerland) and communicate this to ECHA in due time, so that the information on the list is updated before the end of the transition period.

For non-EU/EEA/Switzerland companies that were included on the Article 95 list based on an application for Article 95 inclusion (AS-ACC) the change of representative needs to be reflected in R4BP 3 by transferring the respective Article 95 asset in R4BP 3 to the new representative established within the Union through an AA-TRS application. To be processed, the application needs to include a “request for correction” form (duly filled and signed by the non-EU/EEA/Switzerland company and the former representative) and a letter of appointment of the new representative.

For non-EU/EEA/Switzerland companies that were included on the Article 95 list on other grounds shall inform ECHA of the appointment of representative by submitting the aforementioned documents through the ECHA contact forms.

We recommend doing this two months before the end of the transition period.

In Northern Ireland, the BPR Regulation continues to apply after the transition period. This means that substance or product suppliers on the Article 95 list or representatives of non-EU/EEA/Switzerland companies can continue to be based in Northern Ireland. Please refer to Q&As 1703-1710.

Will my UK(Great Britain)-based company still be able to submit requests for active substance approval or inclusion of a substance on Annex I, after the end of the transition period?

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.

Will ECHA still grant UK(Great Britain)-based companies a right to refer to tests or studies on vertebrates that were submitted to ECHA or to a competent authority in connection with a previous application under the BPR or Directive 98/8/EC, also after the end of the transition period?

The data sharing mechanism under Articles 62 and 63 of the BPR will still be available to such companies, for the purposes of the BPR; for example, where a UK(Great Britain)-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).

Will my UK(Great Britain)-based company still have an access and possibility to submit applications for active substances, Annex I inclusion or technical equivalence via the R4BP 3 submission tool?

Yes, but the application will have 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.

Will the substance or product-specific data owned by my UK(Great Britain)-based company remain protected by the data protection rules of the BPR after the end of the transition period?

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

The manufacturing site of the active substance / biocidal product that my EU-based company is placing on the EU/EEA market is located in the United Kingdom (Great Britain). Do we need to be concerned about the end of the transition period?

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 UK (Great Britain) even after the end of the transition period. You will not need to take any action to continue complying with the BPR. However, shipments to the EU/EEA/Switzerland of this active substance/biocidal product will be, as of the end of the transition period, importations, which has consequences from the viewpoint of other sectorial legislation (e.g. the PIC Regulation, customs).

In Northern Ireland, the BPR Regulation continues to apply after the end of the transition period. This means that shipments to the EU/EEA/Switzerland of active substances/biocidal products will not be treated as importations for the purposes of the BPR Regulation. Please refer to Q&As 1703-1710 for further details.

The manufacturing site of a treated article that my EU-based company is placing on the EU/EEA market is located in the United Kingdom (Great Britain). Do we need to be concerned?

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 will be, as of the end of the transition period, importations, which has consequences from the viewpoint of other sectorial legislation (e.g. customs).

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

What will happen to treated articles that are manufactured outside the EU/EEA and first imported into the UK(Great Britain) before the end of the transition period, and made available on the EU/EEA market after that date?

Any treated article placed on the EU/EEA market is subject to the provisions of the BPR, in particular Articles 58 and 94. After the end of the transition period, shipments from the United Kingdom (Great Britain) to the EU of a treated article will be considered as an import and, consequently, placing on the market of such treated article. If the treated article was placed on the UK 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 after the transition period. This means that shipments of a treated article from Northern Ireland to the EU will not be considered as an import for the purposes of the BPR Regulation. Please refer to Q&As 1703-1710 for further details.

The UK was acting as the reference Member State (refMS) in procedures in sequence (mutual recognition of a biocidal product authorisation in accordance with Articles 33 and 34 of the BPR, applications for minor or major changes under Commission Implementing Regulation (EU) No 354/2013) and renewal of product authorisations under Commission Delegated Regulation (EU) No 492/2014) related to my company’s product and the process is not yet finalised. What effect does the UK withdrawal have on the pending process?

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. 

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

No. There will not be any such effect. The authorisation granted by each EU Member State will remain valid in these EU Member States. However, the authorisation holder has to be established in the EU, EEA country, or Switzerland before the end of the transitional period.

If your company is based in Northern Ireland you do not need to take action.

In Northern Ireland, the BPR Regulation continues to apply after the transition period. 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 is currently considering to submit an application under the BPR for which the UK authorities could act as evaluating Competent Authority (eCA) or reference Member State (refMS). How should we proceed?

Since the withdrawal date, the United Kingdom can no longer act as an eCA/refMS. This also applies during the transition period.

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

Yes. After the withdrawal, the United Kingdom can no longer act as an eCA.

This also applies during the transition period. 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 UK acted as the reference Member State (refMS). Can my company choose another competent authority as refMS?

Since the withdrawal date, the United Kingdom can no longer act as a refMS. This also applies during the transition period. 

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.

An EU Member State has granted my EU/EEA-based company a biocidal product authorisation based on mutual recognition of a UK biocidal product authorisation. Will my company’s product authorisation be affected by the UK withdrawal?

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 UK withdrawal from the EU will not affect the validity of your company’s product authorisation, even if your national authorisation is based on the mutual recognition of a UK authorisation. 

My EU/EEA-based company is listed under Article 95 of the BPR as a supplier of a listed active substance for which we had purchased a letter of access (LoA) from a UK(Great Britain)-based company. Will the end of the transition period affect my company’s listing under Article 95 of the BPR?

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

Will my UK(Great Britain)-based company’s accounts in R4BP 3 remain accessible after the end of the transition period, or will ECHA delete them?

Yes, you will continue to have access, as non-EU companies have access to R4BP 3. UK(Great Britain)-based companies will be 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.

Therefore, until the end of the transition period, the above-mentioned existing products could continue being made available on the market and used in accordance with the provisions of Article 89(2) and (3), provided that the applicant submits a new application 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, before the end of the transition period.

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 would the end of the transition period have on these notifications?

As of the end of the transition period, the authorisation granted by the United Kingdom ceases to be 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.

If you want to keep your product on the market of the notified Member States, your company will need to obtain a new authorisation of the product via the simplified procedure, from an EU Member State, an EEA country or Switzerland prior to the end of the transition period, and then you will have to notify the other relevant Member States, EEA countries or Switzerland.

The UK is acting as the Competent Authority in a regulatory procedure for the UK market related to my company’s product (e.g. national authorisations of biocidal products in accordance with Article 29 of the BPR, simplified authorisations of biocidal products in accordance with Article 26 of the BPR, renewals of biocidal products, in accordance with Article 31 of the BPR same biocidal product under Commission Implementing Regulation (EU) No 414/2013 or changes under Commission Implementing Regulation (EU) No 354). What effect does the end of the transition period have on the pending process?

Under the Withdrawal Agreement, the BPR and related legislation continues to apply to the UK during the transition period. Your pending application is not impacted if it is completed during this period. After the end of the transition period, UK national law will apply and you will need to contact the UK authorities for further information. 

Also note that mutual recognition of a UK authorisation by EU Member States is not possible since the withdrawal date – see Q&A [the one below this one]. 

In Northern Ireland, BPR continues to apply after the end of the transition period. Please see Q&A 1703-1710.

Can I still apply for mutual recognition of a biocidal product authorisation in accordance with Articles 33 and 34 of the BPR in an EU/EEA country of a UK national authorisation?

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.

If a referral is submitted for my product in the context of an ongoing process for mutual recognition in sequence of an authorisation or a process of an application for administrative, major and minor changes of an authorisation, for which the United Kingdom (UK) 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. 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.

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