1. Management of product authorization for in situ cases (IGS)
77th CA meeting – 14 March 2018 Reference : CA-March18-Doc th CA meeting –

2. General overview Recall the main principles of the proposed approach
Presentation of the comments received
Acceptable comments that will be integrated in new version
Debatable comments requiring further reflection
View of the CAs on the comments
Proposed next steps

3. The proposed approach
Gather information on the concentration range of the technical active substance(s) generated by referring to standards for:
Precursor(s) quality
Generation process
Realistic worst case condition(s) under which the IGS may be used
Define the 'performance envelope' of the IGS
Data in accordance with the BPR provisions should be produced by the applicant on sample(s) representing the 'performance envelope' to assess the risks and efficacy of the technical AS generated.
Similar IGS BP could be grouped under a IGS BPF.
Authorisation holder (AH)notifies:
each product falling in the composition range of the BPF (Article 17.6)
the reference to the standards used to describe the performance envelope

4. Comments received from CAs
For inclusion in a revised version of the note
Make reference to the 'generation process' instead of the 'device settings'
Clarification of the concept of similarity
Availability of standards?
Exclude bottled biocidal products from the scope
Alignment to the definitions proposed in the BPC WG recommendations
Use the terminology of Article 19.2(a) – realistic worst case condition(s) of use
Information submitted should be sufficient to demonstrate that the relevant criteria of Article 19 are met
Deletion of the section referring to the diffusion of room disinfectant.

5. Comments received Further discussion/reflection with MS
Information requirements for both the precursors and the technical AS should fulfil the same provisions i.e. those of Annex II, Title 1
Should catalysts be considered as precursors as they are not consumed and are therefore not part of the risk assessment of the AS?
Further clarification with ECHA
Demonstration of the technical equivalence of an active substance generated from a source different from the reference precursor
Synergies between substance approval and product authorization when precursors are authorized

6. Views of the CAs Questions on the approach
Information requirements for precursors when they are the biocidal products? Annex II or Annex III
Should catalysts be regarded as precursors?
Reference to international of national standard? (question raised at the meeting)
Others?
How to manage the authorisation of IGS?
Case of precursors combination
Precursors [A+B] placed on the market for biocidal purposes.
Precursor A placed on the market for biocidal purposes. Precursors B placed on the market for non-biocidal purposes:
Specification for precursor B (e.g. any relevant standard) is defined in the SPC. Only precursors B compliant with the standard could be used in the IGS.
Case of orphan devices
How to minimize the number of orphan devices?
Communication campaign to raise awareness
Current users or manufacturers to take the role of AH

7. Next steps Reactions in writing until 15.06.2018 to SANTE-Biocides
Revision of the draft note based on the comments received.
Consultation of ECHA.
Presentation of a revised note at the next CA meeting.
In line with the principles agreed, ECHA could describe which data requirements would be required to grant an IGS authorisation. Member States cooperation is welcome.