Management of in situ
generated active substances in the context of the BPR
1.
Purpose
of the document
This document is a follow up to previous discussions concerning the management under Directive 98/8/EC and now Regulation (EU) No 528/2012 of in situ generated active
substances and proposes a way forward.
The purpose of this
document is however not to address the case of products, which may benefit from
the transitional measure laid down in Article 93 of the BPR but to clarify
which active substances and precursors are supported - or could be taken over -
under the review programme.
2.
background
At the 52nd CA meeting, the Commission presented a paper CA-July13-Doc.5.1.l proposing a Way forward on the management of in situ
generated active substances in the context of the BPR.
During the discussions of that paper, some concerns arose that the
proposed approach could eventually lead to a substantial increase to the number
of active substance /product-type combinations to be examined under the review
programme. It was therefore agreed to gather more information with a view to
have an informed discussion concerning the impact of the different policy
options.
Against that background, the Commission initiated a wide
consultation of stakeholders to identify the combination of precursors/active
substances currently made available or used on the EU market.
More than 300 hundred contributions were received. The analysis of
these contributions shows that there are 13 active substances
that can be generated in situ from 150 possible combinations of precursors (see
Annex for full details).
As there are still 230 active substances included in the review
programme, approving each active substance / precursor(s) combination as
foreseen under the BPD would lead to a significant increase of the number of
active substance /product-type combinations to be examined under the review
programme.
3.
proposed
way forward
In view of the outcome of the stakeholder consultation, which
confirms the concerns expressed regarding the possible implication on the
review programme of the approach foreseen under the BPD, the Commission
considers that an alternative approach must be considered for the sake of
simplification and efficiency.
The
Commission therefore proposes that under the BPR the eventual approval of an
active substance, which can be generated in situ, shall not refer to the
precursors used for the generation of the active substance, when more than a
single combination of precursors can be used to generate the active substance.
This shall
however not apply to active substance releasers, such as formaldehyde
releasers, which shall continue to be listed in accordance with the practice
developed under the BPD (e.g. Aluminium phosphide releasing phosphine).
If this principle is endorsed, the following approach is then proposed.
1. For substances, which can be
generated in situ, the review programme will now only identify the active
substance supported by the participant(s).
When a precursor was notified and supported under the review programme
for generating a specific active substance (i.e. ammonium sulphate to generate
monochloramine), the name of the precursor will be replaced by the name of the
active substance. In parallel to this modification, opportunity shall also be
given to persons wishing to support this precursor for 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.
2. This opportunity shall only be open to existing active substance
(precursor) / product-type combinations still under assessment under the
current review programme.
The opportunity has already been given to persons interested to support
existing active substance (precursor) / product-type combinations withdrawn
from the review programme to take them over, as it covered any possible
precursors of the substance, and no additional opportunity should thus be given
to support them again under the review programme.
Likewise, it is considered that for substances already included in
Annex I, matters have already been clarified.
3. Persons wishing to support the same existing active substance / product type combination shall submit a joint application.
4. Regarding the timing for the taking over of the role of participants, this
will be done in accordance with the provisions of the new Review Regulation",
in particular with those relating to the review of authoritative guidance
·
At
the latest 12 months after publication of the new approach, which will contain
the names of precursors no longer supported (e.g. ammonium sulphate) and those
of active substances supported instead (e.g. monochloramine), any person
wishing to take over the role of participant for that precursor to be used as
an active substance or for any other active substance to be generated from that
precursor shall submit a declaration of interest to the Commission through the
R4BP.
·
Upon
verifying that the conditions of the taking over are fulfilled, the Agency will
make that information publicly available.
·
Within
6 months from that publication, any person with an interest to take over the
role of participant for the active substance shall notify the Agency through
the R4BP.
·
Within
two years of the acceptance of the notification by the Agency, applications for
approval or inclusion in Annex I shall be submitted.
·
Precursors/active
substances for which an application will have been received and accepted will
be allowed to remain on the market until a decision is taken on their approval.
5. If no application is submitted at
the expected submission date, if the notification is rejected by ECHA, if the
application is rejected by ECHA or by the evaluating Competent Authority, or if
it is withdrawn by the participant no
additional possibility will be given to support the active substance.
If another person wishes to support that active substance, it would
have to be done under the normal procedure of Article 7(1) of the BPR. Until
that active substance is approved, it will not be possible to make it available
on the market or use a biocidal product containing or generating it.
6. Regarding the precursors, these will have to be assessed at the time of product authorisation
and shall be considered as any other non-active substance of the biocidal
products. If they meet the criteria to be regarded as a substance of concern,
relevant data will then need to be submitted.
7. For those precursors, for which
data will have been submitted and assessed under the review programme, the
conclusions of the assessment could be re-used at the time of product
authorisation, with a view to facilitate
that process.
8. Regarding Article 95, as amended, it shall apply in the following way:
·
For
active substances already under assessment, the provisions apply as for
any other existing active substance, meaning that biocidal products containing or
generating the active substance can only remain on the market after 1st
September 2015 if a dossier or a letter of access to the dossier on the active
substance has been submitted to ECHA under Article 95.
·
For
other active substances intended to be supported under the proposed
procedure for taking over, as well as for those for which a dossier will be
submitted pursuant to Article 93 of the BPR, as amended, provisions of Article
95 will apply when a dossier to require the approval of the active substance
will have been submitted and considered as complete.
·
Where
the biocidal product takes the form of a combination of precursors, which are
made available on the market, with a view to generate the active substance in
situ, there will obviously be no active substance supplier in the meaning of
Article 95. In those cases, the product supplier shall then be listed upon
submission of a dossier on the active substance or of a letter of access
to such a dossier.
4.
Conclusion
Member States are invited to discuss the
proposed approach.
