Biocidal Products

Information about Brexit from the conference “Biocides Day 2018” held on 24 October 2018 in Helsinki:

• Klaus Berend, European Commission: “Impact of Brexit” presentation available here.
• Andreas Herdina, European Chemicals Agency: “Impact of Brexit” presentation available here

Information about making biocidal products available on the market during the transition period (in accordance with Article 89, Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the use of and making biocidal products available on the market, or Section 13(1) and Section 14 of Act No. 324/2016 Coll.)

Biocidal products notified by a body settled in the territory of the United Kingdom cannot be made available on the market in the territory of the Czech Republic from ”Brexit date”. The Ministry of Health of the Czech Republic recommends that all companies making such products available on the market in the territory of the Czech Republic (e.g. distributors) contact their business partners before “Brexit date” and draw attention to the necessity of transferring notification to another body settled in the territory of one of the EU-27 member states.

Notification should be transferred in the CHLAP portal between two existing user accounts. A “Transfer Notification” function is available in the overview of each notification.

Another option is submitting a new notification, e.g. by the distributor itself, but it should be considered that in order to submit a notification the notifier must have the full composition of the biocidal product and access to all the mandatory information and documents (e.g. protocols on efficacy determination, Letter of Access to the efficacy data if they are issued for another person than the notifier is).

Useful references: Register of Chemicals and Products

Information about valid authorisations whose holder is a body settled in the territory of the United Kingdom

Authorisations issued to bodies settled in the territory of the United Kingdom for making biocides available on the market in the territory of the Czech Republic will cease to be valid from ”Brexit date”, unless otherwise agreed. In the interests to maintain sufficient chemical diversity and the availability of biocidal products on the market, the Ministry of Health of the Czech Republic recommends that all authorisation holders to transfer the relevant authorisations to another authorisation holder settled in an EU-27 member state. In order to transfer authorisation, an authorisation transfer application (NA-TRS request type) must be submitted through the biocidal products register (R4BP).

A 300 CZK fee is charged for each application in accordance with the Act on Administrative Fees. Processing of the application should take no longer than 30 days.

Useful references:

Supporting document (request for transfer is submitted on an NA-ADC form) 

Register for Biocidal Products (R4BP)

Instructions for submitting an application via Register for Biocidal Products  

Information about requests for national authorisation

Applications for a national authorisation (first authorisation, mutual recognition), where the applicant is a body settled in the territory of the United Kingdom, must ensure the transfer of an application to another body settled in the United Kingdom before “Brexit date”. In the case of applications for the first authorisation in accordance with Article 29 of Regulation (EU) No 528/2012 of the European Parliament and of the Council, the applicant must find a new reference member state that will finish the assessment.

The European Chemicals Agency updated the Register for Biocidal Products in October 2018. Some changes related to Brexit can now be done. More here.

Transfer requests can be consulted with Czech Competent Authority for Biocidal Products at the e-mail address biocidy@mzcr.cz.

Information about the simplified authorisation procedure

If the first authorisation was issued by the United Kingdom as the reference member state, the regulations for Biocidal products made available on the market in the territory of the Czech Republic based on the notification in accordance with Article 27 of Regulation (EU) No 528/2012 of the European Parliament and of the Council and the United Kingdom served as reference member state, notifications for such products cease to be valid from,”Brexit date”. The Biocides Regulation does not allow to transfer the first authorisation to another member state, and the authorisation holder must submit a repeat request for authorisation in accordance with Article 26 of Regulation (EU) No 528/2012 of the European Parliament and of the Council by submitting a new notification in accordance with Article 27 of the same regulation for other member states.

The Ministry of Health of the Czech Republic calls on all participants that make products available on the market in the Czech Republic in accordance with Article 27 of Regulation (EU) No 528/2012 of the European Parliament and of the Council where the first authorisation was issued by the relevant authorities of the United Kingdom to contact their business partners and check whether all the aforementioned steps have already been taken.

Information about active substances assessed for which the United Kingdom is the rapporteur member state

By agreement between the representatives of member states and the European Commission, all active substances where the United Kingdom is the rapporteur member state will be relocated to other EU-27 member states.

This decision will be implemented by a European Commission regulation amending Commission Delegated Regulation (EU) No 1062/2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to Regulation (EU) No 528/2012 of the European Parliament and of the Council. The relocation of active substances will not lead to a situation where some active substances cannot be used in biocidal products after ”Brexit date”.

Useful references:

European Commission Regulation amending the Commission Delegated Regulation (EU) No 1062/2014:

https://eur-lex.europa.eu/legal-content/CS/TXT/?uri=CELEX:32019R0157