CA-July13-Doc.5.1.l
EUROPEAN COMMISSION
DIRECTORATE-GENERAL
ENVIRONMENT
Directorate A – Green Economy
ENV.A.3 - Chemicals
WAY FORWARD ON THE 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 the document "CA-May12-Doc.6.2a Final post CA Active substances generated in situ" agreed during the 46th CA meeting in May 2012
concerning the governance under the Biocidal Products Directive of active substances
generated in situ from precursors.
It intends to propose a way forward on the management of in situ generated active
substances in the context of the BPR.
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
The question of active substances generated in situ, of their precise identification and of
how to manage them and their precursors in the context of the review programme, Annex
I listing and transitional measures was already the subject of several discussions.
These discussions lead to the endorsement of document CA-May12-Doc.6.2a (available
on CIRCABC) providing the following guidance:

Products supplied with the intention to be used as biocidal products fall within
the scope of the Biocidal Products Directive ('BPD') unless otherwise excluded,
for example by Article 1(2) of the BPD, and such products need to be authorised.

Biocidal active substances that are not directly supplied to the user but are
formed in-situ at the place of intended use are, in many cases, also within the
current scope of the BPD and therefore need to be evaluated.

When the use falls within the scope of the BPD, the in-situ generated active
substance and any precursor(s) supplied with a biocidal intention should be listed
in the Annex I entry of the BPD.

The dossier and the assessment report need to contain the appropriate
information on both precursor and in-situ generated active substances in order to
properly assess the safe production and use of the biocidal product.
The document also pointed out that the Annex I listing should indicate the active
substance generated in-situ, as well as any precursors placed on the market with a
biocidal intention. The means of generation could also, where relevant, be included in the
Annex I listing.
As a general rule, the Annex I or IA entry or entries should indicate the in-situ generated
active substance and list the different precursors supplied with a biocidal claim which
have been assessed and found acceptable.
Different precursors generating the same active substance may have been the subject of
different evaluations under the review programme, which will be finalised at different
times. In consequence, it will often be appropriate to list those precursor/active substance
combinations in different Annex I-entries. The same is true for active substances that can
be placed on the market either directly as biocidal products, or indirectly via in-situ
generation, which could therefore have separate Annex I-entries.
Ideally, to facilitate evaluations and bring clarity to the legal status of precursors and insitu generated active substances, both the in-situ generated active substance and its
precursor(s) should have been notified under the requirements of the First Review
Regulation (EC) No 1896/2000 and included in the Annex II of the (new) Second Review
Regulation (EC) No 1451/2007.
However, the interpretation of the applicable rules has varied between Member States,
and may not have corresponded to the present guidance. Therefore, during the review
programme, flexibility is required from all parties involved when it is clear, either from
the submitted dossier or the Annex I inclusion, which precursor(s) and in-situ generated
active substances are covered by the notification or the evaluation.
There are cases where only the precursor(s) was notified, and not the in-situ generated
active substance. In these cases, this notification should be honoured, and the precursor
giving rise to the in-situ generated active should be allowed to remain on the market until
a decision is made regarding its Annex I listing.
A real-case example is monochloramine generated in-situ from ammonium sulphate and
sodium hypochlorite, placed on the market for biocidal purposes. Monochloramine is the
active substance; however this substance was not notified. One precursor, ammonium
sulphate, although having no direct biocidal activity, was notified. Sodium hypochlorite,
an active substance itself, was notified and is supported. In this instance, the Commission
services in charge of biocidal products have taken the view that that monochloraminegenerating products containing ammonium sulphate could remain on the market until a
decision has been taken regarding the Annex I inclusion, as ammonium sulphate had been
notified.
Also, there are cases where only the in-situ generated active substance was notified, and
not the precursor(s). In these cases, this notification should be honoured and the
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precursor(s) should be allowed to remain on the market until a decision is made on
Annex I listing for the active substance generated in-situ from the precursor(s).
A real-case example is peracetic acid generated in-situ from tetraacetylethylenediamine
(N,N′-ethylenebis[N-acetylacetamide]) (TAED) and sodium percarbonate. Peracetic acid
is the active substance generated in-situ, and was notified. The precursors, TAED and
sodium percarbonate were only identified, not notified. In this instance, Member States
should allow the continued marketing of the precursors for the purpose of the in-situ
generation of the active substance until a decision is made on Annex I listing for the
active substance generated from the precursors.
However with the coming into application of the BPR and the fact that all products made
available on the market or used and generating an active substance will fall within the
scope of the BPR, there is a need to clarify matters further, in particular for those
companies, which may have to submit an application under Article 931 to support product
generating substances in situ, when such products were not covered by the BPD (e.g.
propane gas canisters to generate CO2 for the purpose of repelling mosquitoes, even if
they are not supplied with the intention to be used as biocidal products).
3.
PROPOSED WAY FORWARD
As stated above, the current approach is that the approvals of such active substances
should indicate the in-situ generated active substance and list the different precursors
which can generate the active substance, provided these have been assessed and found
acceptable.
This principle will be taken over under the BPR and the eventual approval of an active
substance generated in situ will describe the “precursor(s) – active substance” system and
will only cover the precursors assessed and found acceptable during the active substance
evaluation.
Taking into account the need to clarify the situation of active substances generated in
situ, the following approach is proposed.
1. For substances generated in situ, the review programme will now clearly identify
both the active substance and precursor(s) supported by the participant(s).
2. When an active substance was notified and supported under the review
programme, but without any indication on the precursors that can be used to
generate it (i.e. the peracetic acid, chlorine dioxide cases), the opportunity shall be
given to persons wishing to support specific precursors not covered by the dossier
currently under examination to submit an application to require the approval of
this active substance also generated from that(these) precursor(s).
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As stated in the introduction, 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.
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Conversely, when a precursor was notified and supported under the review
programme for generating a specific active substance (i.e. the ammonium sulphate
case), the opportunity shall also be given to persons wishing to support this
precursor for generating other active substances or, where relevant, for being used
as an active substance on its own to submit an application under the review
programme of existing active substances.
3. 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.
4. Persons wishing to support the same precursor or existing active substance /
product type combination shall submit a joint application.
5. There is a need to clarify what is currently under assessment and supported
by participants. As a consequence, the Commission will contact all
participants in the review programme2 to invite them to indicate in particular
whether:

one or more precursor(s) are currently under assessment as part of the
dossier submitted for the active substance; or

the substance listed is in fact a precursor and the dossier submitted covers
this precursor and an active substance.
6. Participants will have to respond within a month following sending of the
communication, giving accurate information concerning the identity of the
precursor and active substance supported. In parallel, Rapporteur Member States
can also check in the dossier submitted by participants.
7. Responses received from this consultation will allow the Commission to clarify
what precursors and active substances are supported in the review programme
and to give other persons the possibility to take over the role of participant
for precursors or, where relevant, active substances not supported by the current
participant(s) in the review programme. This will be done through a withdrawal
notice.
8. Similar process and timings as in the " Draft Regulation XXX/2013 amending
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Through the R4BP, in which all contact details of participants are now available.
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Regulation (EC) No1451/2007 as regards additional active substances of the
biocidal products to be examined under the review programme" 3 will be
followed as from the moment the Commission publishes a withdrawal notice
(Article 3a(4) of that Regulation).

These persons will have 3 months after that publication in order to send a
declaration of intention to notify their intention to take over the role of
participant;

These persons will have to submit a notification to ECHA within 18
months after the publication of the withdrawal notice. That notification
should contain information requested in table II of Regulation No
1896/2000, and a proof that the precursor/active substance was marketed
in the EU for generating an active substance(s) before the date of
publication of the withdrawal notice;

ECHA will provide an opinion to the Commission whether the
notification can be accepted;

Where a notification can be accepted, the Commission will modify the
review programme Regulation to specify which additional
precursors/active substances will be covered by the review programme;

An application to require the approval of
i. active substances already notified in Regulation (EC) No
1451/2007 but for their generation from other precursors than the
ones currently supported, or
ii. other active substances but generated by precursors already
notified under Regulation (EC) No 1451/21007,
will have to be submitted 2 years after the date when the Commission
modified the review programme Regulation;

The evaluating Competent Authority shall be the same as the one for the
active substance/precursors currently under examination;

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.
9. As a withdrawal notice would therefore already have been published for taking
them over, no additional possibility will be given to support a precursor/active
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The regulation aims at giving the opportunity to support an AS/PT combination to person who failed to
notify or support an active substance with the objectively justified belief that it was not in the scope of
the BPD or that the use was attributed to another product-type (see the Appendix of the present
document)
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substance 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.
If another person wishes to support that precursor/active substance, it would have
to be done under the normal procedure of Article 7(1) of the BPR. Until that
precursor is approved, it will not be possible to place it on the market and use it in
biocidal products.
10. The future Regulation that will amend or repeal Regulation (EC) No
1451/2007, needed for its adaptation with the entry into application of the
BPR, will establish the above mentioned provisions.
11. The provisions of Article 95, as modified by the future amendments of the
BPR (see document Proposal COM/2013/0288 final - 2013/0150 (COD) of 16th
May 2013) will apply in the following way:

For active substances already under assessment and their relevant
supported precursors (ie. precursors supported by current participants), the
provisions apply as for any other existing active substance, meaning that
biocidal products containing the precursor(s) and generating the active
substance can only remain on the market after 1st September 2015 if a
dossier or a letter of access to a dossier has been submitted to ECHA
under Article 95.

For precursors or other active substances intended to be supported under
the proposed procedure, provisions of Article 95 will apply when a dossier
to require the approval of the active substance and the additional
precursor(s), will have been submitted and considered as complete.
Taking into account the above-mentioned proposals, a realistic timing for the
implementation of these provisions could be the following one:
a. Adoption of a Regulation modifying/repealing Regulation
No1451/2007, and establishing the whole procedure: January 2014
(EC)
b. Communication from the Commission to participants in the review
programme in order to have a feedback from participants who currently
supports precursors: September 2013
c. Deadline for these participants to respond to the Commission: November
2013
d. Verification of submitted information by these participants: before 1st
January 2014
e. Publication of a withdrawal notice by the Commission: January 2014
f. Deadline for making a declaration of intention to notify a precursor (3
months after publication of the withdrawal notice): March 2014
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g. Deadline for submitting the notifications (18 months after the publication
of the withdrawal notice): June 2015
h. Deadline for ECHA to give its opinion on the acceptance of the
notifications: August 2015 or October 2015 (in case the applicant has to
complete its notification)
i. For notifications with a positive opinion of ECHA, adoption of a decision
to include these precursors in the notified list of active substances in the
review programme: December 2015
j. Deadline for applicants to submit their application to request the approval
of these precursors (2 years after the date of inclusion into the notified list
of substances in the review programme): December 2017
4.
CONCLUSION
Member States are invited to discuss the proposed approach, which is based on the one
already endorsed for nanomaterials.
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