In situ guidance under the BPR and the case of ozone
During its 59th meeting held on 18-20 March 2015, the EU competent authorities (CA) for biocides have adopted the long awaited guidance document on the management of in situ generated active substances under the Biocidal Products Regulation 528/2012 (BPR). In situ generated substances are substances, which are generated at the place of use from one or more precursors.
In essence, the document consists of two main chapters – the first one covers the in situ substances as such, while the second one focuses on the active substance releasers, which are to be differentiated from the active substance. From companies' perspective, the most practical aspects of the guidance are the accompanying annexes, which are as follows:
- Annex I includes a list of the in situ generated active substances split into categories (presented in different columns). The first one refers to the combinations supported in the dossier under evaluation in the review programme; the second one lists the additional active substance combinations that are currently not supported and that might be supported in the future.
- Annex II relates to the relevant releasers – e.g. substances releasing halogen and substances releasing formaldehyde.
- Annex III explains the procedural steps for taking over the role of a participant in the review programme. What does this mean? Essentially,CAs agreed that as of now, when only a precursor has been notified and supported under the review programme (e.g. ammonium sulphate), it will be replaced by the name of the active substance generated in situ and that precursor (e.g. ammonium sulphate generating monochloramine). In parallel to this new practice, opportunity shall also be given to persons wishing to support this precursor being used as an active substance on its own or to support other active substances generated from this precursor to take over the role of participant and to submit an application under the review programme of existing active substances.
However, the guidance document makes it explicitly clear that this last option will only be open to existing active substance (precursor) / product-type combinations still under assessment under the current review programme.
The Member States also agreed that the next step was for the European Chemicals Agency (ECHA) to invite companies to take over this role of review programme participants for those substance/precursors/combinations, which have been redefined or renamed.
ECHA published its official invitation on 27 April 2015; therefore, market players have 12 months from this date to notify the Agency if they want their precursor-active substance system included in the review programme.
It is important to point out that the guidance in its final version, unlike its draft, does not include a discussion on the specific substances such as ozone, nitrogen or hydroxylradicals.
A separate note only on ozone was presented by the Commission at the CA meeting on 20-21 May 2015. The most controversial issue which can be highlighted in the document concerns ozone generated from oxygen or ozone itself, which were not supported under the review programme of existing active substances, as well as ozone generated from ambient air, water or pure oxygen not supplied with a view to generate ozone for a biocidal use, which was not within the scope of the Biocidal Products Directive 98/8/EC.
However, since both systems are now covered by the BPR, applications for the approval of ozone generated from oxygen as an active substance and its authorization as a biocidal product will have to comply with the transitional procedure envisaged in Article 93 of the BPR, if in situ generation of ozone based on these systems is to be used for biocidal purposes after the deadline of 1 September 2017, in accordance with Member States' national rules.
What this basically means is that the deadline for the submission of the dossier for the active substance approval is 1 September 2016 (Article 93 (a)) or 1 September 2017 at the latest (Article 93 (b)). Nevertheless, since the deadline for complying with Article 95 is in principle 1 September 2015, the CAs decided that market operators making available pure oxygen for the purpose of generating ozone will need a letter of access to the relevant data for Article 95 listing only when the evaluating Member State has accepted or validated a dossier which has been submitted to it for ozone generated from oxygen (i.e. when the new participant will be included on the Article 95 List). Companies making available ozone generated from ambient air, water or pure oxygen not supplied with a view to generate ozone for a biocidal use, will not have to comply with the provisions of Article 95, even after the submission of an application for the approval of ozone generated from oxygen, as in this case no biocidal product consisting of, containing or generating a relevant substance is made available on the market.
Clearly, there is a certain legal ambiguity between the two deadlines, since the application for approval of the active substance under Article 93 comes later in the time line compared to the time of being listed as a supplier under Article 95. It remains to be seen at the next CA meeting in September 2015 how the Member States will react to the Commission's note on ozone generated in situ, and if they will endorse the proposed approach.