Porady dla firm / Pytania i odpowiedzi

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.

Please note that this reply does not yet take into account the impact of the Protocol on Northern Ireland which will become applicable as from the end of the transition period. The reply will be amended in due course accordingly

My UK-based company is the holder of a product authorisation in an EU Member State or of a Union authorisation under the BPR. What effect will the UK withdrawal 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 EU Member State or one of the afore-mentioned 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).

Please note that this reply does not yet take into account the impact of the Protocol on Northern Ireland which will become applicable as from the end of the transition period. The reply will be amended in due course accordingly.

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.

What effect will the UK withdrawal have on substances that are currently in their notification / subsequent application phase with the UK providing the evaluating Competent Authority (eCA), or for which the application for renewal of approval is normally expected to be submitted in the UK, in case the procedure will not be completed by the time of the UK withdrawal?

For existing active substances in the Review Programme,  the Commission Delegated Regulation (EU) 2019/227 applies. New evaluating competent authorities from among the competent authorities of the remaining 27 Member States have been already appointed, and are in charge of the evaluation of the concerned application since 30 March 2019.

According to the  provisions of the Withdrawal Agreement, during the transition period, a competent authority of the United Kingdom cannot act as evaluating competent authority for any application for approval of active substance/product-type combination. For active substances under assessment outside the Review Programme (ex: new active substance), and for the renewal of approval of already approved active substances for which the UK was the previous evaluating Competent Authority, the European Commission and the EU Member States have agreed on the new evaluating competent authority from among the competent authorities of the EU Member States . Applicants have already been informed.

 

My non-EU company is listed as a supplier under Article 95 of the BPR and established outside the EU. My EU representative is established within the United Kingdom. What effect will the UK withdrawal 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 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 company and the former representative) and a letter of appointment of the new representative.

For non-EU 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.

Please note that this reply does not yet take into account the impact of the Protocol on Northern Ireland which will become applicable as from the end of the transition period. The reply will be amended in due course accordingly.

 

My non-EU company is listed as a supplier under Article 95 of the BPR and established outside the EU. My EU representative is established within the United Kingdom. What effect will the UK withdrawal 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 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 in 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 company and the former representative) and a letter of appointment of the new representative.

Non-EU companies that were included on the Article 95 list on other grounds shall inform ECHA of the appointment of representative by submitting the afore mentioned documents through the ECHA contact forms.

We recommend submitting a “request for correction” one month before the UK withdrawal enters into force.

Please note that this reply does not yet take into account the impact of the Protocol on Northern Ireland which will become applicable as from the end of the transition period. The reply will be amended in due course accordingly.

Will my UK-based company still be able to submit requests for active substance approval or inclusion of a substance on Annex I, after the UK withdrawal?

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. 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.

Please note that this reply does not yet take into account the impact of the Protocol on Northern Ireland which will become applicable as from the end of the transition period. The reply will be amended in due course accordingly.

Will ECHA still grant UK-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 UK withdrawal?

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-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-based company still have an access and possibility to submit a dossier via the R4BP 3 submission tool?

Yes. Companies based in third countries have access to R4PB 3 for certain processes, e.g., active substance approval, notifications and submissions. Upon the end of the transition period, the UK companies are regarded as being located in a “third country”.

Please note that this reply does not yet take into account the impact of the Protocol on Northern Ireland which will become applicable as from the end of the transition period. The reply will be amended in due course accordingly.

Will the substance or product-specific data owned by my UK-based company remain protected by the data protection rules of the BPR after the UK withdrawal?

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. Do we need to be concerned about the UK withdrawal?

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 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 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).

Please note that this reply does not yet take into account the impact of the Protocol on Northern Ireland which will become applicable as from the end of the transition period. The reply will be amended in due course accordingly.

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. 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 market if they meet the conditions of the BPR, in particular Articles 58 and 94. However, shipments to the EU 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).

Please note that this reply does not yet take into account the impact of the Protocol on Northern Ireland which will become applicable as from the end of the transition period. The reply will be amended in due course accordingly.

What will happen to treated articles that are manufactured outside the EU and first imported into the UK before the UK withdrawal, and made available on the EU market after the UK withdrawal?

Any treated article placed on the EU market is subject to the provisions of the BPR, in particular Articles 58 and 94. 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, proper labelling information etc.). However, shipments to the EU 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).

Please note that this reply does not yet take into account the impact of the Protocol on Northern Ireland which will become applicable as from the end of the transition period. The reply will be amended in due course accordingly.

My 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.

Please note that this reply does not yet take into account the impact of the Protocol on Northern Ireland which will become applicable as from the end of the transition period. The reply will be amended in due course accordingly.

After the date of UK withdrawal, will an EU Member State still be able to issue a national BPR authorisation on the basis of the recognition of a UK authorisation?

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

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 applicant has chosen a new (EU-27/EEA/Switzerland) Reference Member State (RefMS) by the UK withdrawal date.

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.

The services of the European Commission and ECHA have been working in a coordinated manner with EU Members States, EEA countries and Switzerland in order to identify new refMSs for some products of the product-types 8 and 18 for which authorisation holders had to apply for renewal before the end of 2018. The name of those refMSs has been directly communicated to the relevant holders.  For other products the MSs at CA level and coordination group will explore the possibilities to identify new refMSs.  

An EU Member State has granted my EU-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-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-based company. Will the UK withdrawal from the EU affect my company’s listing under Article 95 of the BPR?

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

Will my UK-based company’s accounts in R4BP 3 remain accessible beyond the date of the UK withdrawal and 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-based companies will be able to perform the same actions allowed for non-EU companies (e.g., submission for Article 95 listings, active substance approval submissions, or submission of notifications following an open invitation for notification). 

Will ECHA continue to grant my UK-based company access to all the information in its R4BP 3 account after the UK withdrawal?

UK-based companies will still have access to their data in R4BP 3.

Can a UK-based company continue to submit applications via R4BP 3 after the UK withdrawal?

A UK-based company can continue to act as a ‘case owner’ in R4BP 3. This means that it will be able, among other things, to submit applications/notifications and monitor the progress of a given case. For instance, UK-based companies can continue to request active substance approvals (or renewals of approval) after the UK withdrawal. However, it is worthwhile recalling here that a biocidal product authorisation can only be granted to an EU (or EEA/Switzerland) based company.

Please note that this reply does not yet take into account the impact of the Protocol on Northern Ireland. ECHA will in due course amend the reply accordingly.

What is the effect of the withdrawal of the United Kingdom on ongoing applications for mutual recognition in parallel for which the United Kingdom is the reference Member State?

As of the withdrawal date, the United Kingdom can no longer act as reference Member State. This also applies during the transition period.

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.

Please note that this reply does not yet take into account the impact of the Protocol on Northern Ireland which will become applicable as from the end of the transition period. The reply will be amended in due course accordingly.

My company notified to a number of Member States, under Article 27(1) of the BPR, a low risk biocidal product authorised in the United Kingdom via the simplified procedure. What effect would the withdrawal of the United Kingdom 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.

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