In situ generated active substances
Biocidal active substances are called in situ generated active substances if they are generated from one or more precursors at the place of use. The approval of such substance requires evaluation of the generated active substance and of the precursor(s) it is generated from, in the context of each product type(PT). Some examples of these combinations are:
- Active chlorine generated from sodium chloride by electrolysis;
- Active chlorine generated from potassium chloride by electrolysis;
- Active bromine generated from sodium bromide and sodium hypochlorite;
- Hydrogen peroxide generated from sodium percarbonate by dissolution in water.
While many in situ generated active substances are included in the Review Programme, the submission of data on the precursors has not been consistent (e.g. data on several precursors were provided in a single dossier), and consequently precursors have not been consistently evaluated.
The European Commission prepared a proposal that aims at defining the in situ generated active substances currently in the review programme by reference to the precursor(s) supported in the dossier under evaluation and to the substance generated. As a result, addition combinations have been introduced to ensure that all the combinations currently placed on the market are adequately evaluated. This proposal was discussed and endorsed by the Member States at their 58th meeting on 12-14 November 2014.
The Commission proposal therefore contains a list of precursor(s)/active substance/PT combinations known to be made available or used on the EU market. Some of the combinations are already supported in the Review Programme but others are not. To keep their biocidal products on the market companies will in some cases need to take action as further explained below.
What will happen next with the in situ generated substances?
- ECHA will publish in its website the finalised Commission list. The list will contain the combinations not currently supported in the Review Programme. If companies wish to take over the role of a participant under the review programme for these combinations they need to make a notification, and subsequently submit an application.
- Some combinations are not eligible for inclusion in the Review Programme (because the active substance was not originally notified, or because the combination is only supported for other PTs) but companies will have the possibility to benefit from the transitional provision of Article 93 of the BPR and submit an application for the approval of the in situ generated active substance. If this submission is done before 1 September 2016 the product, i.e. the precursor(s) generating the active substance, can be maintained on the market.
If a precursor(s)/active substance combination is relevant for more product types (PTs) with some of them falling under the first application route (i.e. taking over the role of a participant under the review programme) while others under the second (Article 93), applicants can decide to apply for the approval of all the combinations through a single submission choosing one of the two application routes.
Do I need to make an application for Article 95 for an in situ generated active substance and its precursor?
Combinations not currently in the Review Programme: The list published by the Agency under Article 95 of the BPR, is a list of "relevant substances". A substance is only "relevant" when the complete substance dossier has been submitted and accepted or validated by a Member State under the BPR or the BPD (Directive 98/8/EC).
Therefore, once the application for the active substance approval, which shall include the information required by Annex II or, for dossiers submitted under the BPD the information required by Annex IIA or IVA and where relevant IIIA, has been accepted or validated by the Member State, the applicant will be included in the Article 95 list for the precursor(s)/active substance/PT combination.
However, where the application has not yet been validated, the substance is not "relevant" and the requirement to comply with Article 95(2) i.e. the obligation for a supplier to be on the list for products to be made available after 1 September 2015, does not apply. In practice, this means that for the additional precursor(s)/active substance/product type (PT) combinations that are introduced as a result of the redefinition of the in situ generated active substances currently in the review programme the deadline of 1 September 2015 will not apply, and the obligations under Article 95 will only apply at a later date i.e. when the approval application is validated.
Combinations already in the Review Programme: The 1 September 2015 deadline applies for combinations currently in the Review Programme. The current entries will be renamed on the Article 95 list to clearly indicate both the active substance and its precursor(s).
Where a combination is there, the alternative supplier of that combination will need to apply to be on the list and be listed by 1 September 2015.