Biocidal Products Committee (BPC)

Opinion on the application for approval of the active substance:

Active chlorine released from hypochlorous acid

Product type: 3

ECHA/BPC/201/2018

Adopted

25 April 2018

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 Opinion of the Biocidal Products Committee
on the application for approval of the active substance active chlorine released
from hypochlorous acid for product type 3

In accordance with Article 89 of Regulation (EU) No 528/2012 of the European Parliament

and of the Council 22 May 2012 concerning the making available on the market and use of
biocidal products (BPR), the Biocidal Products Committee (BPC) has adopted this opinion on
the approval in product type 3 of the following active substance:

Common name: Active chlorine released from

hypochlorous acid

Chemical name of the releaser: Hypochlorous acid

EC No. of the releaser: 232-232-5

CAS No. of the releaser: 7790-92-3

Existing active substance

This document presents the opinion adopted by the BPC, having regard to the conclusions of
the evaluating Competent Authority. The assessment report, as a supporting document to
the opinion, contains the detailed grounds for the opinion.

Process for the adoption of BPC opinions

Following the submission of an application by PuriCore Europe Limited subsidiary of Realm

Therapeutics PLC and Aqualution Systems Ltd on 31 July 2007, the evaluating Competent
Authority Slovak Republic submitted an assessment report and the conclusions of its
evaluation to the Commission on 19 November 2010. In order to review the assessment
report and the conclusions of the evaluating Competent Authority, the Agency organised
consultations via the Technical Meeting (TM-I-2012), BPC (BPC-25) and its Working Groups
(WG-IV-2017, WG-I-2018). During the peer review the common name of the biocide was
changed from ‘Active Chlorine: manufactured by the reaction of hypochlorous acid and
sodium hypochlorite produced in situ’ to ‘Active chlorine released from hypochlorous acid’.
Revisions agreed upon were presented and the assessment report and the conclusions were
amended accordingly.
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Adoption of the BPC opinion

Rapporteur: Slovak Republic

The BPC opinion on the approval of the active substance active chlorine released from
hypochlorous acid in product type 3 was adopted on 25 April 2018.

The BPC opinion was adopted by consensus. The opinion is published on the ECHA webpage
at: http://echa.europa.eu/regulations/biocidal-products-regulation/approval-of-active-
substances/bpc-opinions-on-active-substance-approval.
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Detailed BPC opinion and background

1. Overall conclusion

The overall conclusion of the BPC is that the active chlorine released from hypochlorous acid
in product type 3 may be approved. The detailed grounds for the overall conclusion are
described in the assessment report.

2. BPC Opinion

2.1. BPC Conclusions of the evaluation

a) Presentation of the active substance including the classification and labelling of

the active substance

This evaluation covers the use of active chlorine released from hypochlorous acid (HOCl) in
product type 3. The active substance is generated by electrolysis of a diluted aqueous
solution of sodium chloride, by which chlorine is formed and undergoes rapid hydrolysis to
hypochlorous acid. The generated solution is bottled and forms the product 1.

Hypochlorous acid is very weak acid. Hypochlorous acid is known only in aqueous solution,
formed by the action of water on chlorine. Hypochlorous acid cannot be isolated in its pure
form and it is technically not feasible to determine most of the physico-chemical properties.

Data on hypochlorous acid are mainly based on data of recently performed studies on a
24% available chlorine solution (chlorine + hypochlorous acid + hypochlorite anion) and on
literature data, which also addresses those physical-chemical parameters which are
meaningful for hypochlorous acid. Specification for the reference source is established.

In summary, the physico-chemical properties of the releaser and biocidal product have been
evaluated and are deemed acceptable for the appropriate use, storage and transportation of
the active substance and biocidal product.

Validated analytical methods are available for the releaser hypochlorous acid and for the
active substance as manufactured.

Hypochlorous acid is not currently listed in Annex VI of Regulation 1272/2008. A

classification proposal is currently not available. Consequently, the submission of a CLH
dossier is required. However, it needs to be taken into account that hypochlorous acid
cannot be isolated in its pure form.

b) Intended use, target species and effectiveness

In PT 3, active chlorine released from hypochlorous acid is used as disinfection of cow´s

teats (professional use, 200-300 mg/L active chlorine), disinfection of animal feet in foot
baths (professional use, 35 mg/L active chlorine) and disinfection of areas in which animals
are housed by spraying (professional use, 200-300 mg/L active chlorine). The data on
active chlorine released from hypochlorous acid and the representative biocidal product
have demonstrated sufficient efficacy against the target species. Active chlorine released
from hypochlorous acid acts by non-specific oxidising mode of action.

Active chlorine has bactericidal, fungicidal, yeasticidal, sporicidal and virucidal activity.

1
Originally, the dossier for active chlorine released from hypochlorous acid was submitted under the Biocidal
Products Directive as part of the dossier on active chlorine generated from sodium chloride by electrolysis. During
the peer review it was conclude however that these are distinct active substances. Consequently, the original
dossier was split in two: active chlorine generated from sodium chloride by electrolysis and active chlorine released
from hypochlorous acid.
 6 (11)

The resistance of pathogens to active chlorine is not very probable. Resistance of pathogens
to active chlorine is not higher than that of other active substances with a general mode of
action (oxidation). There is no need for specific resistance management strategies for active
chlorine based disinfectants. They do not differ from those that have already been proposed
for other disinfectants with general mode of action, i.e. strict respect for recommended
concentration use, strict respect for expiration time period, rotation of disinfectants.

c) Overall conclusion of the evaluation including need for risk management

measures

Human health

The toxicological profile of active ahlorine (as an equilibrium of chlorine, hypochlorous acid
and sodium hypochlorite) generated through electrolysis is linked to that of sodium
hypochlorite, hypochlorous acid and chlorine gas. Based on the available toxicological data
covering the standard information requirements for biocides and some observational human
data it was concluded that the only evident toxicological concern is the eye, skin and
respiratory tract irritating potential of sodium hypochlorite solutions. Consequently the
exposure and risk assessment is carried out for local effects only, as potential local irritation
effects would be dominant compared to potential systemic effects. As the relevant use
concentrations are below the reference values for local dermal effects and local oral effects,
risks via the dermal and oral route can be excluded independent from use pattern.
However, potential repiratory exposure depends on the use pattern. Respective exposure
estimates are provided and compared to the established acceptable exposure concentration
(AEC). Assuming the intended uses as described within this report the risk appears
acceptable for all scenarios without specific risk mitigation measures.

A preliminary risk assessment for potential disinfection by-products (DBP) is based on

chlorate as representative potentially critical DBP. This assessment indicates an acceptable
risk if just the concentration of chlorate as given in the identity of the substance is
considered. However, assuming that all of the active chlorine is converted to chlorate (as
representative DBP) it would lead to a borderline to acceptable human worker health risk for
the animal foot/hoof bath applications or unacceptable risk for all other scenarios.
Consequently, more data and a refined assessment are necessary at product authorisation
stage.

A risk assessment for dietary exposure to chlorate as stable metabolite of hypochlorite is

based on an EFSA agreed MRL of 0.01 mg/kg food for chlorate and available BPC draft
guidance for dietary risk assessment. Considering just the concentration of chlorate as
given in the substance identity, the exposure is likely to remain below the MRL. However
considering full conversion of available chlorine to chlorate, MRLs above the EFSA agreed
value of 0.01 mg/kg food commodity would result from all scenarios.
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The table below summarises the exposure scenarios assessed.

Summary table: human health scenarios

Scenario Primary or secondary exposure and Exposed group Conclusion
description of scenario

Primary inhalation and dermal exposure while

Teat cleaning cow teats by spraying with active
disinfection chlorine solution (50 mL) each time the teat Professional users Acceptable
cup is removed from the teat.

Active chlorine solution (50 mL) is dosed

Disinfection of automatically into the water supply to give a
animal feet in 35 mg/L solution. Primary inhalation and
Professional users Acceptable
foot baths dermal exposure while This solution is then
transferred to the footbath

Primary inhalation and dermal exposure while

Spraying of
active chlorine solution is sprayed by the
animal houses Professional users Acceptable
professional using a lance

Exposure to
Primary inhalation and dermal exposure during
IBC containing
mixing and loading Professional users Acceptable
b.p.

Secondary inhalation exposure of bystanders

Bystanders
exposed to active chlorine when they are Bystander Acceptable
present during use under PT3.

Secondary (indirect) exposure to children and adults can occur from touching freshly
treated surfaces after spraying of an animal house. However, the exposure concentrations
are 0.03% which is below the dermal reference value of 1%. Consequently, there is no
concern for the child from indirect exposure (touching freshly treated surfaces after
disinfection of an animal house) to available chlorine. Potential bystander exposure would
be lower compared to the primary exposure and is therefore also considered acceptable.

Environment

The sum of the hypochlorite ion, hypochlorous acid and chlorine is defined as active chlorine
or available chlorine. For the chemical reactivity in an aqueous solution with the same active
chlorine concentrations and the same pH conditions, it is irrelevant whether active chlorine
is generated from either chlorine gas, calcium hypochlorite, sodium hypochlorite, or from
sodium chloride by electrolysis. Therefore, all studies investigating hypochlorite aqueous
solutions were used for the evaluation and assessment of active chlorine. For the water
component algae were the most sensitive species in long term testing. No toxicity data were
available for sediment and soil organisms, so the thresholds for these comparments were
calculated from data for aquatic organisms using the equilibrium partitioning method. Active
chlorine is highly reactive: it reacts rapidly with organic matter in the sewer, sewage
treatment plant (STP), surface water and soil. Where organic matter is present, it acts as a
highly reactive oxidizing agent. Subseqently, active chlorine degrades rapidly in all
compartments. Degradation was taken into account between release to the facility drain and
inflow into the STP and in the STP. Degradation during the disinfection process and after
release of effluent from the STP was not taken into account when calculating emissions.
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Aggregated risk assessment has been performed and no unacceptable risk was identified.
Degradation was considered for the compartments surface water, sediment and soil.

Disinfection by-products are formed due to the use of active chlorine, for example in the
STP. The risk to the environment from exposure to disinfection by-products was not
evaluated due to the absence of guidance.

The table below summarises the exposure scenarios assessed.

Summary table: environment scenarios

Scenario Description of scenario including environmental Conclusion
compartments
Disinfectant for Terminal disinfection of animal housing with emission Acceptable
animal housing via waste water to Sewage Treatment Plant (STP) and
to manure. Compartments assessed: STP, air, surface
water, sediment, soil and groundwater
Disinfectant for Disinfection of cow teat-dips with emission via waste Acceptable
teat-dips water to Sewage Treatment Plant (STP) and to
manure. Compartments assessed: STP, air, surface
water, sediment, soil and groundwater
Disinfectant for Disinfection of footwear and animal feet with emission Acceptable
animal feet via waste water to Sewage Treatment Plant (STP) and
to manure. Compartments assessed: STP, air, surface
water, sediment, soil and groundwater

While degradation was assumed in the sewer the risks for surface water and sediment were
acceptable. No unacceptable risks were identified for the soil compartment and for
groundwater. For the air compartment the volatilisation of hypochlorite from the STP was
considered. As the predicted concentrations were very low the risks for air were considered
acceptable.

Overall conclusion

The risk from the use of the biocidal product for professionals and for the environment is
acceptable for all intended use scenarios. More data and a refined risk assessment for
disinfection-by-products needs to be provided at product authorisation stage. The MRL
setting and dietary risk assessment needs to be reviewed at product authorisation stage.
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2.2. Exclusion, substitution and POP criteria

2.2.1. Exclusion and substitution criteria

The table below summarises the relevant information with respect to the assessment of
exclusion and substitution criteria:

Property Conclusions

CMR properties Carcinogenicity (C) no classification Active

required chlorine
released
Mutagenicity (M) no classification from
required hypochlorous
acid does not
Toxic for no classification fulfil criterion
reproduction (R) required (a), (b) and
(c) of Article
5(1)

PBT and vPvB properties Persistent (P) or not applicable Active

very Persistent chlorine
(vP) released
from
Bioaccumulative not applicable hypochlorous
(B) or very acid does not
Bioaccumulative fulfil criterion
(vB) (e) of Article
5(1) and
Toxic (T) not applicable does not fulfil
criterion (d)
of Article
10(1)

Endocrine disrupting An assessment according to the latest ED criteria2 has not

properties been undertaken. However, there was no evidence of
specific effects on endocrine tissues and organs. A decision
on whether or not active chlorine released from
hypochlorous acid fulfils criterion (d) of Article 5(1) cannot
be made.

Respiratory sensitisation No classification required. Active chlorine released from

properties hypochlorous acid does not fulfil criterion (b) of Article 10(1)

Concerns linked to critical Active chlorine released from hypochlorous acid does not
effects fulfil criterion (e) of Article 10(1)

Proportion of non-active Active chlorine released from hypochlorous acid does not
isomers or impurities fulfil criterion (f) of Article 10(1)

2
Regulations, Commission delegated regulation (EU) 2017/2100 of September 2017 setting out criteria for
determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European
Parliament and Council
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Consequently, the following is concluded:

Active chlorine released from hypochlorous acid does not meet the exclusion criteria laid
down in Article 5 of Regulation (EU) No 528/2012.

Active chlorine released from hypochlorous acid does not meet the conditions laid down in
Article 10 of Regulation (EU) No 528/2012, and is therefore not considered as a candidate
for substitution. The exclusion and substitution criteria were assessed in line with the “Note
on the principles for taking decisions on the approval of active substances under the BPR”
and in line with “Further guidance on the application of the substitution criteria set out
under article 10(1) of the BPR” agreed at the 54th and 58th meeting respectively, of the
representatives of Member States Competent Authorities for the implementation of
Regulation 528/2012 concerning the making available on the market and use of biocidal
products. This implies that the assessment of the exclusion criteria is based on Article 5(1)
and the assessment of substitution criteria is based on Article 10(1) (a, b, d, e and f).
However, the exclusion criteria were not assessed in line with the criteria laid down in the
Annex of Regulation (EU) No 2017/2100 which apply as of 7 June 2018.

2.2.2. POP criteria

POP criteria are not applicable to inorganic substances, such as active chlorine released
from hypochlorous acid.

2.3. BPC opinion on the application for approval of the active substance active
chlorine released from hypochlorous acid in product type 3

In view of the conclusions of the evaluation, it is proposed that active chlorine released from
hypochlorous acid shall be approved and be included in the Union list of approved active
substances, subject to the following specific conditions:

1. Specification established for hypochlorous acid (as dry weight min 90.87% w/w)
releasing active chlorine, which is placed on the market as biocidal product (bottled).
Hypochlorous acid is the predominant species at pH 3.0 - 7.4.

2. The authorisations of biocidal products are subject to the following condition(s):

a. The product assessment shall pay particular attention to the exposures, the risks
and the efficacy linked to any uses covered by an application for authorisation, but
not addressed in the Union level risk assessment of the active substance.

b. For products that may lead to residues in food or feed, the need to set new or to
amend existing maximum residue levels (MRLs) in accordance with Regulation
(EC) No 470/2009 or Regulation (EC) No 396/2005 shall be verified, and any
appropriate risk mitigation measures shall be taken to ensure that the applicable
MRLs are not exceeded.

Since no CLP proposal is available, it cannot be concluded, if the active substance fulfils the
criteria according to Article 28 (1) to enable inclusion in Annex I of Regulation (EU) No
528/2012.
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2.4. Elements to be taken into account when authorising products

1. The following recommendations and risk mitigation measures have been identified
for the uses assessed. Authorities should consider these risk mitigation measures
when authorising products, together with possible other risk mitigation measures,
and decide whether these measures are applicable for the concerned product:

a. Disinfectant by-products are formed as a consequence of the use of active

chlorine. An assessment of the risks of Disinfectant by-products will be performed
at product authorisation stage.

b. The EFSA Panel on Contaminants in the Food Chain identified a potential concern
related to exposure of infants and young children to chlorate via food and drinking
water (EFSA Scientific Opinion on “Risks for public health related to the presence
of chlorate in food”; EFSA Journal 2015; 13:4135). The Commission is considering
approaches to address chlorate residues in food in the context of the legislation on
drinking water and/or food hygiene. Any action proposed by the Commission
should be taken into account at product authorisation.

c. An assessment of the risk in food and feed areas may be required at product
authorisation where use of the product may lead to contamination of food and
feeding stuffs.

2.5. Requirement for further information

Sufficient data have been provided to verify the conclusions on the active substance,
permitting the proposal for the approval of active chlorine released from hypochlorous acid.

However, further study is required:

- A new 5-batch analysis of the company Aqualution Systems Ltd should be provided to
the evaluating Competent Authority (Slovakia) as soon as possible but not later than
6 months before the date of approval of the active substance.

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