EUROPEAN COMMISSION
DIRECTORATE-GENERAL
ENVIRONMENT
Directorate A – Green Economy
ENV.A.3 - Chemicals
CA-May14-Doc.4.2
56th 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 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.
Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 2 299 11 11
E-mail: ENV-BIOCIDES@ec.europa.eu
More than 300 hundred contributions were received. The analysis of these contributions
shows that there are 13 active substances1 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.
1
Active Chlorine* (2), Carbon dioxide* (3), Chlorine* (10), Chlorine dioxide* (37), Formaldehyde* (14),
Hydrogen peroxide* (7), Hypobromous acid (8), Hypochlorous acid (24), Monochloramine (8), Nitrogen*(2),
Ozone (7), Peracetic Acid* (17) and Sodium hypochlorite* (10)
2
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 guidance2

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.
2
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)
3
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:
4.

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.
CONCLUSION
Member States are invited to discuss the proposed approach.
4
Annex
Active substances and combinations of precursors identified through the stakeholder
consultation
Active substance3 (n4)
Combinations of precursors
Active Chlorine* (2)
Hypochlorous acid* and Sodium hypochlorite*
Sodium chloride
BCDMH* (1)
(Active bromine and active chlorine releaser)
None
Bromide activated Chloramine (BAC) (1)
Ammonium bromide and Sodium hypochlorite*
Bromine (1)
Sodium bromide* and Potassium bromide
Bronopol* (1)
(Formaldehyde releaser)
None
Calcium hydroxide* (1)
Calcium carbonate and Calcium oxide*
Calcium Magnesium Dihydroxide Oxide (1)
Dolomite and Calcium Magnesium Oxide
Calcium Magnesium Oxide (1)
Dolomite
Calcium oxide* (1)
Dolomite
Calcium percarbonate (1)
Calcium carbonate
Carbon dioxide* (3)
Oxalic acid and Water
Propane
Propane and Butane
Chlorine* (10)
5,5-Dimethylhydantoin and Sodium hypochlorite*
Ammonium carbamate (source of ammonia) and Sodium hypochlorite*
Cyanuric acid and Sodium hypochlorite*
Magnesium chloride hexahydrate and Potassium chloride
Not specified
Pentapotassium bis(peroxymonosulfate) bis(sulfate) and Sodium chloride
Sodium hypochlorite*
Titanium
Titanium and Silver*
Urea and Sodium hypochlorite*
Chlorine dioxide* (37)
Chlorine*
Hydrochloric acid and Sodium chlorite
Not specified
Sodium chlorate
Sodium Chlorate and Hydrogen Peroxide*
Sodium chloride and Hydrochloric acid
Sodium chlorite
Sodium chlorite and Acetic acid
Sodium chlorite and Boric acid
Sodium chlorite and Chlorine
Sodium chlorite and Citric acid
Sodium chlorite and Citric acid anhydrous
3
The * indicates that the substance is either approved/included in annex I of the BPR or supported under the
review programme.
4
Number of combinations of precursors.
5
Sodium chlorite and Disodiumperoxodisulfate
Sodium chlorite and Hydrochloric acid
Sodium chlorite and Hypochlorous acid
Sodium chlorite and Ion exchanger + catalyst
Sodium chlorite and L(+)-Lactic acid
Sodium chlorite and Lactic acid
Sodium chlorite and Organic acid (glycolic acid)
Sodium chlorite and Pentapotassium bis(peroxymonosulfate) bis(sulfate)
Sodium chlorite and Phosphoric acid
Sodium chlorite and Potassium peroxymonosulfate
Sodium chlorite and Sodium bisulfate
Sodium chlorite and Sodium bisulfate (sodium hydrogen sulfate)
Sodium chlorite and Sodium chloride
Sodium chlorite and Sodium chloride brine
Sodium chlorite and Sodium dichloro isocyanurate dihydrate
Sodium chlorite and Sodium hydrogensulfate
Sodium chlorite and Sodium hypochlorite*
Sodium chlorite and Sodium hypochlorite
Sodium chlorite and Sodium peroxodisulfate
Sodium chlorite and Sodium persulfate
Sodium chlorite and Sorbic acid
Sodium chlorite and Various, see comments
Tetrachlorodecaoxide (TCDO)* and Hydrochloric acid*
Tetrachlorodecaoxide (TCDO)* and Sulphuric acid
Troclosene sodium* and Citric acid*
Copper (Cu++)* (1)
Chelate formed from copper sulfate Pentahydrate, Citric Acid and Ammonia.
Copper (Cu++) and Silver (Ag+) (1)
Copper and Silver*
DBNPA* (1)
Not specified
DCDMH* (1)
(Chlorine releaser)
None
Diammonium peroxodisulfate (1)
Ammonium sulfate*
Dipotassium peroxodisulfate (1)
Potassium sulfate
Disodium peroxodisulfate* (1)
Sodium sulfate
DMDMH* (1)
(Formaldehyde releaser)
None
EDDM (DMO) (1)
(Formaldehyde releaser)
None
Formaldehyde* (14)
(benzyloxy)methanol*
1,3,5 Trialkyl, 1,3,5, Triazines * and EGForm*
cis CTAC*
CTAC*
DMDMH*
EDHO*
EGForm*
HHT*
HPT*
MBM*
Oxazolidin / MBO*
Paraformaldehyde
6
Sodium N-(hydroxymethyl)glycinate*
TMAD*
Glutaral* (1)
Reaction product of Glutaral and Tris(hydroxymethyl)aminomethane
HHT* (1)
(Formaldehyde releaser)
None
Hydrogen peroxide* (7)
Beta-d-glucose pentaacetate
Not specified and ?
Sea water
Sodium hydroxide
Sodium percarbonate
sodium sulfate
Sulphuric acid
Hydroxylradical (•OH) (3)
Hydrogen peroxide*
Water
Water particles from ambient air
Hypobromous acid (HOBr) (8)
BCDMH* and Water
Bromine chloride (stabilized)
Sodium bromide*
Sodium bromide* and Hydrogen Peroxide*
Sodium bromide* and Hypochlorous acid
Sodium bromide* and Ozone
Sodium bromide* and Pentapotassium bis(peroxymonosulfate) bis(sulfate)*
Sodium bromide* and Sodium hypochlorite*
Hypochlorous acid (24)
BCDMH* and Water
Calcium Hypochlorite*
Calcium Hypochlorite* and Water
Chlorine gas
DCDMH* and Water
DCEMH* and Water
Pentapotassium bis(peroxymonosulfate) bis(sulfate)*
Pentapotassium bis(peroxymonosulfate) bis(sulfate)* and Sodium chloride
Pentapotassium bis(peroxymonosulfate) bis(sulfate)* and Troclosene sodium
Potassium chloride and Water
Sea water
Sodium bromide* and Sodium hypochlorite
Sodium chloride
Sodium chloride and Sodium bromide
Sodium chloride and Water
Sodium dichloroisocyanurate dihydrate*
Sodium dichloroisocyanurate dihydrate* and Water
Sodium hypochlorite*
Sodium hypochlorite* and Water
Symclosene*
Symclosene* and Water
Troclosene sodium*
Troclosene sodium* and Water
Troclosene sodium, dihydrate* and Water
Methylene glycol (1)
DMDMH* and Water
7
Monochloramine (8)
Ammonia and Chlorine*
Ammonia and Sodium hypochlorite*
Ammonium sulfate* and Sodium chloride
Ammonium sulfate* and Sodium hypochlorite*
Diammonium hydrogenorthophosphate and Sodium hypochlorite*
Liquid ammonia and Sodium hypochlorite*
Nitrogen* (2)
Mix of Ammonium sulfate and Diammonium hydrogenorthophosphate and Potassium
hypochlorite
Mix of Ammonium sulfate and Diammonium hydrogenorthophosphate and Sodium
hypochlorite*
Ambient air
Not specified
Ozone (7)
Not specified
Oxygen
Oxygen and Ambient air
Oxygen and Water
Propane
Titanium dioxide
Water and Deionized water
Pentapotassium bis(peroxymonosulfate)
bis(sulfate)* (1)
Peracetic Acid* (17)
May be used directly. As an oxidising agent, it may also react with other substances to form
further active substances. In particular it may react with halide ions to generate hypohalous
acids.
1,3-Diacetyloxypropan-2-yl acetate and Hydrogen Peroxide*
Acetic acid and disodium carbonate compound with hydrogen peroxide (2:3)
Acetic acid and Hydrogen Peroxide*
Acetyltriethylcitrate and Hydrogen Peroxide*
D-sorbitol Hexaacetate and Hydrogen Peroxide*
Methylacetate and Hydrogen Peroxide*
N-acetylcaprolactam and Hydrogen Peroxide*
Pentaacetylglucose and Hydrogen Peroxide*
Tetra-acetylethylenediamine (TAED) and Disodium carbonate compound with Hydrogen
peroxide
Tetra-acetylethylenediamine (TAED) and Hydrogen Peroxide*
Tetra-acetylethylenediamine (TAED) and Percarbonate
Tetra-acetylethylenediamine (TAED) and Sodium carbonate peroxyhydrate
Tetra-acetylethylenediamine (TAED) and Sodium perborate
Tetra-acetylethylenediamine (TAED) and Sodium perborate monohydrate
Tetra-acetylethylenediamine (TAED) and Sodium percarbonate
Tetra-acetylethylenediamine (TAED) and Water
various, see comments
Performic acid (1)
Hydrogen peroxide* and Formic acid*
Peroxyacetic acid (1)
Acetic acid* and Hydroperoxide
Phosphine (2)
Aluminium phosphide* and Water
Magnesium phosphide and Water
Plasmacluster ion (1)
Oxygen and Water in the air
Polymeric form of the 3-(trihydroxysilyl)
propyldimethyloctadecyl ammonium chloride
(1)
3-(trihydroxysilyl) propyldimethyloctadecyl ammonium chloride and 3-(trimethoxysilyl)
propyldimethyloctadecyl ammonium chloride (AEM 5772)
Potassium Percarbonate (1)
potassium carbonate
Silver ion (Ag+) (1)
Elemental silver* and Silver nitrate
Sodium chlorite (1)
Hydrochloric acid
Sodium hypobromite (1)
Sodium hypochlorite* and Sodium bromide
8
Sodium hypochlorite* (10)
Chlorine and Caustic soda
Chlorine and Caustic soda solution
Chlorine and sodium hydroxide
Not specified
Salt (sodium chloride) Low Bromide salt/ Ultra low Bromide salt
Sea water
Sodium chloride
Sodium chloride and Potassium chloride
Sodium chloride and Sea water
Sodium chloride and Water
Sodium hypochlorite and hydrogen peroxide
(1)
Sodium chloride and Water
Sodium perborate (1)
Sodium tetraborate decahydrate*
Sodium percarbonate (1)
Sodium carbonate
Sulfur dioxide* (1)
Sulfur
9