CA-March15-Doc.5.1-Final
Revised on 23 June 2015
59th meeting of representatives of Members States Competent
Authorities for the implementation of Regulation 528/2012 concerning the making
available on the market and use of biocidal products
Management
of in situ generated active substances in the context of the BPR
1.
Purpose of the document
This document provides details of the management of in situ generated active substances under Regulation (EU) No 528/2012 as agreed at
the 59th CA meeting.
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, it was
pointed out that the proposed approach could 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 contributions were received.
After several consultations and a workshop held
on 15 October 2014 with participation of Member States and stakeholders, it was
concluded that it would be better to consider as many precursors as possible at
the substance approval stage, despite the potential workload implied, with a
view however to make the product authorisation process more efficient
afterwards.
The analysis however confirms the initial
concern that such an approach would entail a significant number of re-submissions.
On some substances, it seems nevertheless possible to perform an assessment
that could cover various precursors at the same time. Therefore, a compromised
approached was agreed for certain substances, such as chlorine dioxide.
From that analysis, it also appears that some of
the precursors/active substances combinations currently placed on the market were
not supported under the review programme (e.g. monochloramine), or are
supported for different product-types than the ones for which they are used.
3.
way forward
Section 3.1 addresses the situation of in situ
generated active substances, whilst section 3.2 brings clarification regarding
active substance releasers, as these should be clearly distinguished from in
situ generated active substances. Lastly, the case of specific substances such
as ozone, nitrogen or hydroxylradicals remains to be addressed.
3.1.
Substances
generated in situ
In situ generated active substances can be
defined as substances, which are generated at the place of use from one or more
precursors.
Review
programme
All applications under evaluation in the review
programme include a dossier on the active substance and a dossier on a
representative biocidal product, which for in situ generated active substances
will be the precursor(s).
For all substances generated in situ, the active
substance shall be defined by reference to the precursor(s) supported in the
dossier under evaluation and to the substance generated.
This may in certain cases lead to a
re-definition of the substance, as originally notified, and/or to the creation
of additional entries, when data on several precursors were provided in a
dossier, or when multiple dossiers have been submitted for a substance (e.g. chlorine dioxide to be redefined as Chlorine
dioxide generated from sodium chlorite by electrolysis and as chlorine
dioxide generated from sodium chlorate and hydrogen peroxide in the presence of
a strong acid)[1].
For those substances to be redefined, Article
13, 14 and 17 of Regulation (EU) No 1062/2014[2] (hereafter referred as the
Review Programme Regulation) shall apply and persons affected by the substance
re-definition shall be given the possibility to take over the role of
participant[3].
Upon receiving information from ECHA that
notifications to take over the role of participant have been found compliant,
the Commission will amend part 1 of Annex II of the Review Programme Regulation
so that in situ generated active substances are described as indicated in Annex
I of this document.
Substance approval
At the time of the substance
approval, the Commission implementing Regulation would then refer to the
precursor(s) supported in the dossier and to the active substance that will be
generated from this(ese) precursor(s), including when relevant the generation
method.
Article 95
Likewise, the list published by
ECHA shall be updated and in situ generated active substances supported under
the review programme shall be described as indicated in Annex I of this
document.
Current participants in the
review programme will be listed as substance/product suppliers.
Other companies will be added to
the list provided they submit their own dossier, or an LoA to such a dossier.
In the case of in situ generated
active substances, the dossier or LoA will need to cover data on both the in
situ generated active substance and the precursor(s), which form the
representative product, supported in the dossier under evaluation.
Suppliers of substances to be used as precursors for the in
situ generation of active substances included in the review programme have to
submit to ECHA their own dossier on the precursor(s) and the in situ generated
active substance, or a letter of access to such a dossier, in so far as the
precursor(s) placed on the market and the active substance generated from this(ese)
precursor(s) are the same as the ones
supported under the review programme[4]. These suppliers will have to be listed by 1
September 2015.
It is to be noted though that, as
Article 95(2) refers to biocidal products, substances made available on the market
without any indication (e.g. butane in the form of gas canisters) that they can
be used as precursors for the in situ generation of an active substance would
not be covered, although they might be used for that purpose. Such substances
could therefore still be used during the transitional period provided for under
Article 93 of the BPR. However, beyond this transitional period, such a use of
a substance will be considered as use of a biocidal product and would not be
allowed unless that biocidal product is authorised.
In addition, the additional
precursor(s)/active substance combinations listed in the fourth column of Annex
I would initially not be included in the Article 95 list (as no “complete
substance dossier” according to Article 95(1) would have been submitted). Consequently,
the deadline of 1 September 2015 does not apply to suppliers of these
additional precursor(s)/active substance combinations. However, as soon as a
“complete substance dossier” has been submitted under Article 13 of the Review
Programme Regulation or Article 93 of the BPR and accepted, the substance would
be included in the Article 95 list and consequently Article 95(2) would apply.
Technical equivalence
It is acknowledged that a
comparison of the chemical composition and hazard profile of the in situ
generated active substances would be technically difficult, if not impossible,
to achieve, as it may in particular be challenging to establish a reference
source.
It might however be possible to
establish technical specifications or to refer to existing standards, such as CEN
standards. These technical specifications could be established either for the
active substance itself or its precursors, as appropriate, at the time of the
substance approval.
It will then have to be ensured
and demonstrated at the time of product authorisation that the precursors or
the active substances, as appropriate, meet the agreed specifications.
Finally, when an in situ generated active
substance may also be placed on the market itself (e.g. peracetic acid),
specifications would still have to be established in order to allow the
establishment of technical equivalence in those cases where the active
substance itself is placed on the market.
Article
93
Several in situ generated active substances are
either not supported under the review programme or are supported for different
product-types than the ones for which they are used.
Those in situ generated active substances will
therefore not be able to benefit from the provisions of Article 13 of the Review
Programme Regulation, which can only cover what was already within the scope of
the BPD.
They could however benefit from the provisions
of Article 93 as precursors for the in situ generation of active substances
were not considered to be in the scope of the Directive in so far as no claim
was made that these precursors could be used for a biocidal purpose.[5]
Article
13 of the Review Programme Regulation vs. Article 93 of the BPR
For some in situ generated active substances,
submissions of applications could be done for some product-types on the basis
of Article 13 of the Review Programme Regulation, for others on the basis of
Article 93 of the BPR.
This would happen in cases where the re-defined
precursor(s)/active substance combination is supported under the review
programme for greater number of product-types than those in use for the
precursor(s)/active substance, for which the role of participant is to be taken
over (see for instance active chlorine).
In such cases, for the sake of simplification,
the applicant may decide to group all product-types together and use only one
application route (i.e. Article 13 of the Review Programme Regulation or
Article 93 of the BPR).
Consortium
Specific
precursor(s)/active substance combinations may be supported individually. This
does however not rule out that a consortium could be set up to support
different generation systems through the same application. This could be of
interest for monochloramine, peracetic acid or active bromine.
Biocidal
products
For in situ generated active substances, the
biocidal product which is subject to authorisation before it can be supplied or
used is either:
- the substance(s) or mixture(s) generating the
active substance; or
- the active substance generated from substances
or mixtures, which cannot themselves be authorised as biocidal products.[6]
3.2.
Active
substance releasers
Active substance releasers are
substances which upon use release a substance, which has a biocidal activity.
For such substances, no other precursor is required, the reaction is taking
place under certain conditions and not necessarily at the place of use.
The substance released and the
substance releaser shall be regarded as the active substance and be managed as such.
Furthermore, the name of the
active substance will be the combination of the names of the substance released
and of the substance releaser (e.g. Formaldehyde released
from N,N'-methylenebismorpholine).
This name will be used for the
substance approval as well as for the purpose of Article 95 listing.
Technical equivalence
The requirement to proof
technical equivalence at product authorisation applies to biocidal products
containing active substance releasers.
Technical equivalence shall
confirm the similarity, as regards the chemical composition and hazard profile,
of the active substance releasers being compared.
Article 95
The list will refer to the name
of the active substance releaser and the substance released.
Current participants in the
review programme will thus be listed under the combination of the active
substance releaser and the substance released.
Other companies will be added to
the list provided they have their own dossier on the active substance, or a
letter of access to such a dossier.
4.
Conclusion
The principles of this note were
endorsed at the 58th CA meeting and the annexes finalised at the 59th
CA meeting after a final consultation between the Commission services, the
evaluating competent authorities and the participants concerned.
In accordance with Article 14 of
Regulation (EU) No 1062/2014, the European Chemicals Agency will now publish an
open invitation to take over the role of participant for those
substance/precursor/product-type combinations, which have been the subject of a
redefinition, as described in Article 13 of that Regulation.
Furthermore, it shall be noted
that the list of substances described in the fourth column of the tables in
Annex I and II is not exhaustive and that there might be other active substance/precursor/product-type
combinations placed on the market, which might be eligible for a taking over
pursuant to Article 14 of Regulation (EU) No 1062/2014 or for which
applications can be submitted pursuant to Article 93 of the BPR.
However, for new systems (i.e.
active substance/precursor/product-type combinations which were not made
available on the market on 1 September 2013), the active substance will need to
be approved and the biocidal product authorised before such new systems can be
made available on the market.
Finally, for the purpose of
product authorisation, it shall be recalled again that any company can be
authorisation holder. It may thus be either the company supplying the
precursors, the company manufacturing the devices in which these precursors
will be used, or the company using the device with a view to generate the
active substance.
[1] Further details of the proposed
re-definitions are provided in Annex I (in column 3 of the tables).
[2] Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014
on the work programme for the systematic examination of all existing active
substances contained in biocidal products referred to in Regulation (EU) No
528/2012 of the European Parliament and of the Council (Text with EEA relevance
) OJ L 294, 10.10.2014, p. 1–34
[3] Further details on the process are provided in Annex III.
[4] These are listed in the third column of Annex I of this document.
[5] Those precursor/active substance combinations which could benefit
from the provisions of Article 93 of the BPR are listed in the last column of
the tables provided in Annex I.
[6] This would apply to ozone generated from ambient air, active
chlorine generated from sea water.
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