1) ECHA-Guidance of the Biocidal Product Regulation
http://echa.europa.eu/documents/10162/15623299/biocides_guidance_active_substance_suppliers_en.pdf
The base of the Twin Oxide-technology are the Combinations some substances the following list 2).
2)
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.
More than 300 hundred contributions were received. The analysis of
these contributions shows that there are 13 active substances[1]
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.
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 guidance[2]
·
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.
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:
·
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.
4.
Conclusion
Member States are invited to discuss the
proposed approach.
Annex
Active substances and combinations of precursors
identified through the stakeholder consultation
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
|
|
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
|
|
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
|
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*
|
|
Mix
of Ammonium sulfate and Diammonium hydrogenorthophosphate and Potassium
hypochlorite
|
|
Mix
of Ammonium sulfate and Diammonium hydrogenorthophosphate and Sodium
hypochlorite*
|
|
Nitrogen*
(2)
|
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)
|
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.
|
Peracetic
Acid* (17)
|
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
|
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
|
[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] 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] 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.
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