1. Management of product authorisations for in situ generated AS : where are we?
CA-July18-doc.4.5 5th July - Brussels

2. Clarification about the chemical identity of the precursors that could be authorised
The precursor and its sources should be described at the approval stage
The active substance(s), impurities, and by-products should be identified at the approval stage
Compliance with standard might provide enough information on the quality of precursors proposed for authorisation

3. There is a need to further clarify the articulation between the assessment of the approval of the AS and the assessment for the product authorisation
It should be clarified what additionnal assessment is needed at the autorisation stage compared to the assessment for the AS approval

4. Section 4.4 of the CA note should remain
Catalysts
Clarification is needed on how catalysts are taken into account in the assessment of the generation process
Section 4.4 of the CA note should remain
Information on parameters determining the in situ generation are important for the authorisation condition and should be described in the SPC

5. Section 4.5 on mixtures of precursors
Case 1
Authorisation granted to Pa + Pb
Case 2
+ Pb Authorisation granted to Pa
Pb = chemical placed on the market with non-biocidal purposes (e.g. strong acid)
Case 1 : First indent of the definition of Biocidal Product would apply as the precursor is the BP
Case 2 : Second indent of the definition of Biocidal Product would apply as the active substance is the BP
Pa +Pb Pa