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In situ generated active substances – September 2016 deadline

In situ generated active substances – September 2016 deadline

In situ generated biocidal active substances are active substances generated from one or more precursors at the place of use. Until now, active substance evaluation has not consistently considered both the precursors and the generated active substance, so active substances generated in situ have been redefined to specify the precursors from which the active substance is generated. In addition, the approval of such biocidal active substance requires evaluation of potential risk of the generated active substance and their precursor(s) in the context of each product type as well. Sale or use of a biocidal product containing or consisting of a precursor needs biocidal product authorisation.

Types of in situ biocides:

  • Release of active substances from a single precursor, e.g. formaldehyde releasers
  • Chemical reaction of substances in aqueous solutions, e.g. chloramine generation
  • Active substance formed from commodity or environmental sources using specific equipment, e.g. ozone from air

Several in situ generated active substances/product type combinations are not supported under the review programme, so these companies (precursor supplier, biocidal product formulator, manufacturer of the generated equipment, product user) can now notify ECHA to have their precursor-active substance system included in the review programme in order to be able to continue using it in Europe. The deadline for this application is by 1 September 2016. If this new system is not notified before this date, the derogation lasts only until 1 September 2017.

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.

Please check the most updated, but not exhaustive, list of precursor(s)/active substance/product type combinations (Annex I) that are available or used on the EU market. Some of the combinations are already supported in the review programme but others are not. Please confirm if your precursor(s)/active substance/product type combinations is/are currently supported in the review programme. If not, you will have to notify to ECHA your intention to be a participant in the review program and submit a proper application under the Biocide Regulation for both the active substance and the precursor/s. If this submission is done before 1 September 2016 the biocidal product, i.e. the precursor(s) generating the active substance, can be maintained on the market.

Please contact us for further information and assistance on this matter, we will be pleased to help you.

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