Consequences for biocidal products
On 31 January 31st 2020 the United Kingdom (UK) left the European Union. What does this mean for applications and authorisations for biocidal products? Various biocidal products derive their authorisations from assessments preformed by another EU member state. What are the consequences if this assessment is (or was) performed by the UK’s Competent Authority (CA)?
Brexit consequences for various authorisations
On October 23th 2018, the EU published a document on the consequences of Brexit for biocidal product authorisations. The consequences for the various authorisations are listed below.
Applications for existing and new active substances and Union applications:
These have now been reclassified at the initiative of the Commission.
Mutual recognition in sequence
From January 31st 2020, the United Kingdom can no longer act as a eCA/refMS. Applicants should take this into account when they intend to apply for mutual recognition in sequence in the Netherlands. The file needs to be handed over to another Member State taking up the role as eCA/refMS before an application for mutual recognition in sequence can be submitted to the Ctgb.
National applications or applications for renewal with the UK as RMS of the original authorisation
From January 31st 2020, the United Kingdom can’t act as the eCA/refMS for the renewal. Applicants need to find another Member State taking up the role as eCA/refMS before an application for renewal can be submitted via R4BP. In 2020/2021 the Ctgb will accept a very limited number of applications for renewal as an eCA because of the high workload of the Ctgb. As such, applicants are requested to include the Ctgb as a CMS in a grouped submission.
A simplified authorisation in the Netherlands that is based on an authorisation in the UK will no longer be valid in the Netherlands from January 31st 2020. These products must be removed from the Dutch market at the latest on January 31st 2020.
The Regulation stipulates that the Netherlands has 60 days to complete an application for parallel trade of a product. The parallel trade permit is valid for 10 years. After that, a new permit must be applied for. However, this will no longer be possible on the basis of the UK authorisation.
Article 95 list:
From January 31st 2020 on, there is no legal ground for bioicdal product authorizations in the EU-27 Member States if the supplier of the active substance or of the product is not included in the Article 95 list at that time. Timely amendments to the inclusion in the Article 95 list, or modification of the supplier to one that is established in the EU-27, EEA or Switzerland are the responsibility of the industry. Modification of the Article 95 list are processed by ECHA. Changes of a supplier in an authorized biocidal product must be requested with a change to the authorization at the Ctgb.
Brexit does not affect the regulations regarding treated articles.