Union Authorisation: Experience and Top Tips by the German CA (Competent Authority)
Union Authorisation: Experience and Top Tips by the German CA (Competent Authority)
On the 28th and 29th of March 2023, Kerona Scientific held their third virtual Dublin Biocide Symposium dealing with key regulatory aspects relevant to the registration of products and active substances under the Biocidal Products Regulation (BPR, Regulation (EU) 528/2012). The first day of the symposium included presentations on EU biocide developments, Union Authorisation (UA), lab and field efficacy testing and data access.
Dr. Annika Cimdins-Ahne of the German CA, the Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (BAuA), gave a presentation on the “Applications for Union Authorisation: Experience and Top Tips by the German CA”. Annika began the presentation by explaining how UA is valid in all member states (MS) therefore, no mutual recognition (MR) is necessary with this type of application. However, for certain Product Types (PT) UA applications are not permitted. UA is also not applicable in the case of active substances that meet the exclusion criteria, or where there are no similar conditions of use across the European Union (EU). Consequently, it is important to send a “Pre-submission” request (UP-APP) to ECHA to check applicability prior to UA application (UA-APP).
Annika proceeded to give a synopsis of the IT tools R4BP3, SPC and IUCLID, which are used to make applications and facilitate communication between the applicant and the evaluating competent authority (eCA), MS, Commission and ECHA.
Annika then outlined the differences between NA (National Authorisation) and UA. Annika defined the documents to be submitted for a UA application as well as the additional documents in the case of a biocidal product family (PBF), as well as documents specific to Germany. She also provided evaluation timelines and steps after completion of the evaluation. She warned of the various issues that cause delays in the processing of the applications and gave advice on how to avoid these delays as well as key points on the letters of access (LoA).
Some of Annika’s top tips from the presentation are summarised below:
- Contact the eCA to schedule a pre-submission meeting in time!
- Read the note for Guidance on BPF concept: CA-July19-Doc4.2-Final_rev2
- Check fact sheets and templates provided on BAuA homepage: https://baua.de/EN/Topics/Safe-use-of-chemicals-and-products/Chemicals-law/Biocides/Authorisation-procedure.html
- Follow the ECHA practical guide on LoA “BPR Practical guides – special series of data sharing”
- For Germany: use the LoA template from the BAuA homepage
Some useful links are also provided – see the summary at the end of this blog.
If you missed the BP Symposium and would like to read all of Annika’s tips, a copy of the presentations is available for purchase on the publications section of the Kerona website at the link https://kerona.ie/product/dublin-biocides-symposium-2021-speakers-presentations/
If you need assistance with the registration of biocidal products in the EU, please do not hesitate to contact the biocidal products regulatory team at Kerona info@kerona.ie
Useful Links:
https://www.reach-clp-biozid-helpdesk.de/EN/Home/Home_node.html
Questions regarding product applications:
https://www.baua.de/EN/Topics/Safe-use-of-chemicals-and-products/Chemicals-law/Biocides/Biocides_node.html
https://www.baua.de/EN/Topics/Safe-use-of-chemicals-and-products/Chemicals-law/Biocides/Authorisation-procedure.html