Management of product authorisation for in situ cases

Management of product authorisation for in situ cases

The ‘CA-July19-Doc.4.1-Final’ note agreed by Member States’ Competent Authorities for biocidal products for the management of product authorisation for in situ cases was revised in June 2024. The Netherlands has requested to amend the documents according to ‘CA-Sept24-Doc.7.4’ which was discussed during the 105th meeting of representatives of Member States’ Competent Authorities on the 26 and 27th of September.  

According to the note, under the first indent of the definition of biocidal product under Article 3, the formulation containing the precursor will be authorised as a biocidal product. When authorising in situ generated biocidal products, three case-types can be considered:  

• Case-type 1: the in situ biocidal products involve an in situ generation system (IGS) only based on the mixing of two or more [formulations containing the] precursors without using a device  

• Case-type 2: the in situ biocidal products involve an IGS based on one or more [formulations containing the] precursors used in a device 

• Case-type 3: the in situ biocidal products involve an IGS based on any substance or mixture that contains one or more catalyst(s) generating after activation free radicals. To be identified as a case-type 3, the following elements should be present: 

1.  the radicals have to be generated from components present in the immediate environment of the substance or mixture such as air and water 
2.  the catalyst plays a key role in the in situ generation. Hence, the radical generation is solely triggered by the activated catalyst 
3.  the biocidal product is the substance or mixture containing the catalyst, and it is what is placed on the market 

The main change suggested by The Netherlands is using  the word ‘substance’ under Case-type 3 instead of ‘coating’ as mentioned in the previous document ‘CA-June24-Doc.7.3.b’.  

Under the second indent of the definition of a biocidal product under Article 3 (1) (b), the active substance (a.s.) generated in situ will be authorised as a biocidal product and the following case type (Case-type 4) should be considered: 

• Case-type 4: the in situ biocidal products involve an IGS generating an in situ a.s. from a [formulation containing the] precursor not placed on the market for biocidal purposes and using a device or from catalyst(s) not falling under case-type 3 

The note also explains further how the definition of a single biocidal product under Article 3(1)(r) of the BPR and the definition of a ‘biocidal product family’ (BPF) under Article 3(1)(s) must be combined with the specificities of the different case-types to decide if the in situ generated products belong to a family or not. The variability of the concentration of active and non-active substances depends on the settings of the devices and other parameters. Therefore, this is considered as a non-intended variation.  

Kerona Scientific can support you with your biocidal product authorisation, whether this is for a single product or a BPF. Please get in touch with the Kerona team at info@kerona.ie or give us a call at +353 1 849 5284.