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Biocidal Products Regulation

In-situ generated a.s.

What data on precursors are expected to support the assessment of active substances generated in situ?

Guidance is under development and subject to consultation with the Member State competent authorities.

How can I prepare a dossier in IUCLID for the active substance and the precursor(s), including waiving of data?

To submit Annex II data for precursors for each precursor of an in situ active substance, you have to create a separate substance dataset in IUCLID.

Depending on the properties of a substance, you should use the corresponding dataset template in IUCLID for either a "BPR Substance of concern" (if the precursor is considered a substance of concern) or "BPR Basic information" (substance) to insert the required data.

If a study has been waived according to the specific rules for waiving data requirements in Article 21 of the BPR, then you must identify this in an endpoint study record.

For further information, see ECHA's Biocides Submission Manual Technical guide: using IUCLID MANUAL (Annex II) at the following link: http://echa.europa.eu/documents/10162/14938692/bsm_01_using_iuclid_en.pdf

How can I report the conditions under which the in situ generated active substances are created?

You need to provide a comprehensive description of the generation process. This should include the generation conditions as pH value, concentrations of the precursors and all parameters that impact the generation and reaction schemes of each single step in the chemical reaction from the precursors to the in situ generated active substance (i.e. including the active constituents and impurities.

Impurities may comprise by-products, unreacted precursors (starting materials) and constituents of secondary or incomplete reactions).

You should report this information under the section "2.8 Method of manufacture" of the data package on the active substance generated in situ, i.e. in the respective "BPR active substance information" dataset template in IUCLID.

How can I derive reference specifications and reference sources (technical specifications)?

You can normally derive the reference specification from the five-batch analysis. However, for in situ generated active substances, reliable analytical information might not be achievable. Therefore, you should calculate the concentration of each constituent (active constituent, impurities) in a stoichiometric way based on the precursors and their applied concentrations.

This calculation should indicate the chemical species and their concentrations generated in situ, but it cannot be regarded as the reference specification of the active substance. The specification will be defined through the composition of the precursors.

You should report this information under Sections 2.9 and 2.10 Specification of purity and identity of impurities of the data package on the active substance generated in situ, i.e. in the respective “BPR active substance information” dataset template in IUCLID.

A five-batch analysis is not required for the in situ generated active substance if the generated substance is not stored or isolated. However, for the precursors, certificates of analyses might be acceptable.

If the in situ generated substance is stored, even for a short time, sampling seems to be possible and therefore a five-batch analysis has to be provided. (ref. Section 2.11 Analytical profile of Annex II to the BPR.)

 

Is a risk assessment for the precursors needed or is hazard assessment sufficient for the precursors?

Both risk assessment and hazard assessment are required for precursors.

Further guidance is under development.

 

Do I have to assess the efficacy of precursors?

You have to provide the efficacy data for the active substance generated in situ. Depending on the system, you could approach assessing the efficacy in different ways. The manufacturer of the in situ generated active substance is best placed to provide ways of demonstrating the substance efficacy. That includes, for example, testing on the pure active substance together with evidence that a corresponding concentration is achieved with the in situ generation system.

This further implies that you have to provide information on the storage stabilities of the precursors necessary to generate the in situ active substances.

Do I need to assess the substitution and exclusion criteria for the precursors?

According to the competent authority meeting document (CA-Nov15-Doc.5.5), only the properties of the in situ generated active substance are considered to define whether the exclusion, substitution and Annex I listing criteria are met during the approval process. However, please note that an in situ generated active substance includes active constituents and impurities, where impurities may comprise in situ generation reaction by-products, unreacted precursors (starting materials) and constituents of secondary or incomplete reactions.

Link to CA-Nov15-Doc.5.5
https://circabc.europa.eu/d/a/workspace/SpacesStore/a0cb1d57-9287-4cd2-975e-e473b411cb5f/CA-Nov15-Doc.5.5%20-%20Final%20-%20Classification%20and%20in%20situ%20generated%20AS.doc

What needs to be classified?

As the harmonised classification plays a key role in assessing the exclusion or substitution criteria, the active substance generated in situ must be classified. 

A harmonised classification will be proposed by the evaluating competent authority (eCA) on the in situ generated active substance.

When the eCA considers that it has appropriate information on the precursors, they may also submit a CLH dossier for the precursors to ECHA to establish or amend the harmonised C&L. This can later help in the product authorisation stage, and could be important for product authorisation. (See competent authority meeting document CA-Nov15-Doc.5.5)

Warnings resulting from the classification of the active substance generated in situ should be added in the instructions of use accompanying the products placed on the market, i.e. the precursors.

Link to CA-Nov15-Doc.5.5

https://circabc.europa.eu/d/a/workspace/SpacesStore/a0cb1d57-9287-4cd2-975e-e473b411cb5f/CA-Nov15-Doc.5.5%20-%20Final%20-%20Classification%20and%20in%20situ%20generated%20AS.doc

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