http://echa.europa.eu/regulations/biocidal-products-regulation/approval-of-active-substances/existing-active-substance?panel=notification-procedure#notification-procedure
Vorhandener
Wirkstoff
The Review Programme is the name
commonly used for the work programme for the examination of existing biocidal
active substances contained in biocidal products. The programme was set up by
the European Commission under the Biocidal Products Directive (BPD) and
continues under the Biocidal Products Regulation (BPR).
Existing active substances are those
substances which were on the market on 14 May 2000 as an active substance of a
biocidal product (for purposes other than scientific or product and process-orientated
research and development). The existing active substances which were accepted
to be examined in the Review Programme were those which were identified as such
and for which a notification was accepted, as set out in Annex II to Commission
Regulation (EC) No 1451/2007.
The detailed rules for the Review
Programme have been adapted to the provisions of the BPR in the new Review
Programme Regulation (EU) No 1062/2014, which repeals and replaces
Commission Regulation (EC) No 1451/2007.
The transitional provisions laid down in
Article 89 of Regulation (EU) No 528/2012 allow biocidal products containing an
active substance included in the Review Programme (for a given product-type) to
be made available on the market and used, subject to national rules, until
three years after the date of their approval (shorter timeframes apply in case
of non-approval).
In Annex II part 1 of the Review
Programme Regulation, the active substances which are under evaluation are
listed.
In addition, the Review Programme
Regulation adapts the processes for the evaluation of a dossier to align them
to those described in the BPR for new active substances or in Regulation (EU)
No 88/2014 for the amendment of Annex I.
Furthermore, the Review Programme
Regulation provides a defined role for ECHA and sets out procedures on how to
join or replace a participant in the Review Programme by mutual agreement, how
to withdraw as a participant, how to take over the role of participant in
certain situations and introduces the possibility to add substance/PT
combinations to the Review Programme, under certain conditions.
The Review Programme is foreseen to be
completed by 2024.
Changes
of elements of the Review Programme
Change in participant for a
substance/product-type combination
New combinations of
substance/product-type in the Review Programme
Taking over the role of participant
following substance identity redefinition
ECHA's open invitations
Notification
procedure
To ensure that no substance is unduly
maintained or included in the Review Programme without subsequently being
evaluated, interested companies have twelve months to make a notification of
essential data regarding the substance. Once the notification is declared
compliant by ECHA, a participant has two yearsto submit an
application.
The fee to be paid to the Agency per
notification of a substance/product-type(s) combination is 10 000 Euros,
according to the Fee Regulation (EU) No 564/2013. This fee will be deducted
from the application fee for approval of the active substance/product-type
combination.
Application
for approval or inclusion in Annex I
See
also
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