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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.
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).
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.
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.
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.
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.
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.
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).
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”.
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” (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 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).
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).
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.
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.
No. This will no longer be possible.
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.
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.
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.
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).