Important
for manufacturers and suppliers of biocidal active "chlorine
dioxide"!
At the
meeting on April 27 in the BauA Dortmund was informed that a change will take
place in the list referred to in Article 95. "Chlorine Dioxide"
should be replaced by "Chlorine Dioxide generated from sodium chlorite by
..." In order for the listed manufacturers and suppliers of Sodium
chlorite are also included in the list referred to in Article 95.
Wichtig für
Hersteller und Lieferanten des bioziden Wirkstoffes „ Chlordioxid“!
Auf der Tagung der BauA am 27.April in Dortmund wurde
mitgeteilt, dass eine Änderung in der Liste nach Artikel 95 erfolgen wird. „
Chlorine Dioxide“ soll ersetzt werden durch „Chlorine Dioxide generated from
sodium chlorite by…“ Damit sind die gelisteten Hersteller und Lieferanten von
Sodium Chlorite ebenfalls in der Liste nach Artikel 95 erfasst.
http://echa.europa.eu/regulations/biocidal-products-regulation/in-situ-generated-active-substances
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.
No comments:
Post a Comment