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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. The Commission updated its information on 23 October 2018.
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.
We recommend submitting a “request for correction” one month before the UK withdrawal enters into force.
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.
Yes. Data protection applies to all information submitted for the purposes of the BPR or its predecessor, the Biocidal Products Directive.
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.
As of the withdrawal date, the United Kingdom can no longer act as an eCA/refMS. This also applies if a withdrawal agreement is concluded since the United Kingdom cannot act as eCA/refMS during the transition period.
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.
The services of the European Commission and ECHA have been working in a coordinated manner with EU-27 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.
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).
As of the withdrawal date, the United Kingdom can no longer act as the eCA. This also applies if a withdrawal agreement is concluded since the United Kingdom cannot act as eCA/refMS during the transition period. The services of the European Commission have been working in a coordinated manner with EU-27 Members States, EEA countries and Switzerland in order to identify new eCAs for concerned existing active substances. The European Commission will adopt and publish, before the withdrawal date, an amendment to the Review Programme Regulation listing the existing active substances and the eCAs that will assess them. The name of the new eCAs has already been directly communicated to the participants in the Review Programme. The services of the European Commission have also identified new eCAs for the assessment of pending applications for approval of those active substances that are not subject to the Review Programme Regulation (e.g. new active substances). The name of those eCAs has also been directly communicated to applicants and will be made known on the ECHA's website.
As of the withdrawal date, the United Kingdom can no longer act as reference Member State. This also applies if a withdrawal agreement is concluded since the United Kingdom cannot act as eCA/refMS during the transition period.
Therefore, where the United Kingdom is currently acting as refMS, you are advised to carefully monitor the UK authority’s progress and take the relevant actions. For example, if you see indications that the UK authority will not conclude the procedure by the withdrawal date, you may consider changing to another evaluating Member State. In this case, the new refMS will continue handling the relevant tasks referred to in Article 34 of the BPR.
The services of the European Commission and ECHA have been working in a coordinated manner with EU-27 Members States, EEA countries and Switzerland in order to identify new refMSs for some on-going applications. The name of those refMSs has been directly communicated to the relevant applicants.
However, where no Member State takes over the role of refMS, there could be different consequences depending on the procedural stage at which the application is by the withdrawal date:
- Where the United Kingdom as refMS has entered, before the withdrawal date, the elements referred to in Article 34(5) of the BPR in R4BP (i.e. the agreed summary of biocidal product characteristics (SPC) and the final assessment report, together with any agreed terms or conditions imposed on the making available on the market or use of the biocidal product), the cMSs may proceed to grant the national product authorisation in accordance with Article 34(6) of the BPR.
- Where the current refMS (i.e. the United Kingdom) has not entered, before the withdrawal date, in R4BP the above-mentioned elements, the applicant will need to submit a new application for mutual recognition in parallel to a new refMS of his choice and to the relevant cMSs in accordance with Article 34(1) and (2) of the BPR, respectively.
With the submission of the initial application assessed by the United Kingdom the applicant fulfilled his 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, 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 his 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 withdrawal date.
As of the withdrawal date 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-27 Member State, an EEA country or Switzerland prior to the withdrawal of the United Kingdom, and then you will have to notify the other relevant Member States, EEA countries or Switzerland.