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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.

My UK-based company is the holder of a product authorisation in an EU-27 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 in 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. You will therefore need to transfer the authorisation to a new holder established within an EU-27 Member State or one of the afore-mentioned countries before the UK withdrawal. 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).

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?

The European Commission and our Agency, in cooperation with the EU-27 Member States, will prepare the groundwork for a handover of such pending cases.

My UK-based company is listed as a supplier according to Article 95 of the Biocidal Products Regulation. With a view to the UK withdrawal, what do we need to do?

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 representative established within the Union (or the EEA countries or Switzerland) and communicate this to ECHA (by submitting a “request for correction”) in due time, so that the information on the list is updated before the date of the UK withdrawal from the EU. Otherwise, the UK supplier will be removed from the Article 95 list, and biocidal products from this source would no longer be allowed to be made available on the EU market.

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 (by means of a “request for correction”) in due time, so that the information on the list is updated before the date of the UK withdrawal from the EU.

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-27 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.

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 its withdrawal, the UK will become such a “third country”.

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-27-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” (such as the United Kingdom will be after the date of its withdrawal). 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 UK withdrawal date, importations, which has consequences from the viewpoint of other sectorial legislation (e.g. the PIC Regulation, customs).

The manufacturing site of a treated article that my EU-27-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 UK withdrawal date, importations, which has consequences from the viewpoint of other sectorial legislation (e.g. customs).

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-27 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 UK withdrawal, 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-27, proper labelling information etc.). However, shipments to the EU of this treated article will be, as of the UK withdrawal date, importations, which has consequences from the viewpoint of other sectorial legislation (e.g. customs).

Currently, the UK is acting as evaluating Competent Authority (eCA) or reference Member State (refMS) in an on-going regulatory procedure related to my company (e.g. active substance approval, renewal of an active substance approval, Union authorisation, simplified authorisation procedure, mutual recognition 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). What effect will the UK withdrawal have on the pending process?

According to the BPR, the role of evaluating Competent Authority (eCA) or reference Member State (refMS) is attributed to (the Competent Authority of) a Member State. Through the EEA Agreement as well as the Mutual Recognition Agreement with Switzerland, this is extended to further include Iceland, Liechtenstein, Norway, and Switzerland. As a business operator affected by an ongoing procedure for which the UK is currently acting as eCA/refMS, you are advised carefully monitor the UK authority’s progress and take the relevant actions. For example, if you see clear indications that the UK authority will not conclude the procedure by the date of the UK withdrawal, you may consider changing to another evaluating Member State. The services of the European Commission and our Agency will work with the EU-27 Member States, EEA countries and Switzerland to establish a coordinated approach to ensure a timely agreement and technical transfer of the file in case such a change is needed. We will also communicate the agreements reached on such transfers. This will be particularly relevant for the review programme of existing active substances for which the Commission Delegated Regulation (EU) No 1062/2014 assigned the United Kingdom as evaluating Member State in a legally binding manner.

My company benefits from an authorisation issued by a EU-27 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-27 Member State will remain valid in these EU-27 Member States.

After the date of UK withdrawal, will an EU-27 Member State still be able to issue a national BPR authorisation on the basis of the recognition of a UK authorisation?

No. This will no longer be possible.

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?

Until the withdrawal date, the UK remains a member of the European Union, with all the rights and obligations that derive from membership. Thus, you may still choose the UK as eCA/refMS. However, with a view to the timing of the UK withdrawal, you should carefully take into account the timelines that are to be expected for concluding the respective regulatory procedure and take the relevant actions. For example, if you recognise a risk that the authority may not conclude the procedure by the date of the UK withdrawal, it may be preferable to choose another eCA/refMS in order to avoid having to seek a change to another eCA/refMS at a later stage.

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. 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. The services of the European Commission will work with Members States, EEA countries and Switzerland to establish a coordinated way forward so that the Commission and our Agency can provide clear indications to prospective applicants, in due course.

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?

Yes. 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-27-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-27-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. 
My company handles a low risk biocidal product, authorised in the UK via the simplified procedure. May we notify the placing on the market of that product to EU-27 countries after the UK withdrawal?
No. The BPR will no longer apply to the UK after the UK withdrawal. Therefore, your company will need another country to grant a new authorisation of the product via the simplified procedure, prior to the UK withdrawal (i.e., either an EU-27 Member State, an EEA country, or Switzerland). 
Will my UK-based company’s accounts in R4BP 3 remain accessible beyond the date of UK withdrawal 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 or active substance approval submissions). 

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-based company.

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