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EPA Update Report: benzyl alkonium chlorides reassessment (APP203921)
26 March 2020
Staff update report for reassessment of benzyl alkonium chlorides (APP203921)
epa.govt.nz ii info@epa.govt.nz
Overview
A modified reassessment under section 63A of the Hazardous Substances and New Organisms Act
(the Act) covering benzyl alkonium chlorides (BACs) and substances which contain BACs.
Substance Benzyl alkonium chlorides
Application code AP203921
Application type To modify an existing approval for a hazardous substance under
Section 63A of the Hazardous Substances and New Organisms Act
1996 (the Act)
Applicant Environmental Protection Authority
Purpose of the application To reassess benzyl alkonium chlorides
Date application formally received 11 December 2019
Submission period 19 December 2019 – 27 February 2020
Submissions Two (2) submissions were received:
Datachem
Diversey
Information requests and time
waivers
No time or information waivers were applied to this application
Consideration date 9 April 2020
Staff update report for reassessment of benzyl alkonium chlorides (APP203921)
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Executive summary
The Environmental Protection Authority (EPA) submitted an application for reassessment to update
the hazard classification of a number of benzyl alkonium chlorides (BACs) and substances containing
BACs. Revised hazard classifications were proposed in the application, which were based on
information contained in overseas regulatory reviews (United States, Canada, Australia) and
databases (Europe). The resulting changes to prescribed controls arising from the revised hazard
classifications were also presented. The application was formally received on 11 December 2019.
It was decided that the application for reassessment would be progressed as a publicly notified,
modified reassessment in accordance with section 63A of the Hazardous Substances and New
Organisms Act 1996 (the Act).
The public notification period was open from 19 December 2019 until 27 February 2020. Two
submissions were received.
This document contains summaries of the submissions, and the EPA’s responses.
The EPA considers that there is an overall positive effect in making the proposed changes to the
approvals and no significant adverse effects. With the appropriate controls in place, the risks are
considered to be negligible, whereas the benefits are non-negligible. As the positive effects outweigh
the adverse effects, it is recommended that the decision-making committee approves the modified
reassessment.
This document recommends substances subject to this reassessment be updated as per the
application form, taking into account the corrections contained herein. Please note that this is not a
decision and is only one of a range of information sources that the decision-making committee will use
when considering the application.
Staff update report for reassessment of benzyl alkonium chlorides (APP203921)
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The Reassessment Process
STEP TWO: Reassessment application
Public submissions
Formal receipt of application
Gathering information
STEP ONE: Grounds for reassessment
Evaluation of submissions
Consideration
Decision
Hearing
Staff update report for reassessment of benzyl alkonium chlorides (APP203921)
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Contents
Overview ..................................................................................................................................ii
Executive summary .........................................................................................................................iii
The Reassessment Process ............................................................................................................iv
Contents ..................................................................................................................................v
1 This document and background ............................................................................................1
2 Process, consultation, and notification .................................................................................1 Receipt of application .......................................................................................................................... 1 Scope of application ............................................................................................................................ 1 Notification of application .................................................................................................................... 1 Response from other government agencies ........................................................................................ 1
3 Submissions............................................................................................................................2 Submissions received ......................................................................................................................... 2 WorkSafe advice ................................................................................................................................. 4
4 Corrections to information in the application form ...............................................................5
5 Overall evaluation and recommendation ...............................................................................6
Staff update report for reassessment of benzyl alkonium chlorides (APP203921)
epa.govt.nz info@epa.govt.nz 1
1 This document and background
1.1 This document is the Update Report for the modified reassessment of benzyl alkonium
chlorides (BACs). The purpose of the Update Report is to provide responses to issues raised in
submissions, and to provide an update to the proposals detailed in the application for
reassessment document.1
1.2 The Environmental Protection Authority (EPA) reviewed the classification of BACs and
substances which contain BACs. The proposed revisions were based on regulatory reviews
undertaken by authorities in the US, Canada, and Australia, and information held in European
Chemicals Agency (ECHA) databases.
2 Process, consultation, and notification
Receipt of application
2.1 This reassessment application was received on 11 December 2019.
Scope of application
2.2 The EPA’s Chief Executive considered the content of the application and decided to use the
EPA’s discretionary power in section 63A(1) of the Act to proceed with the application as a
modified reassessment. It was decided that the scope of the modified reassessment would
include an assessment of the hazard classifications of the substances, and controls under the
Act.
Notification of application
2.3 The Acting General Manager Hazardous Substances and New Organisms decided not to use
the EPA’s discretionary power in section 63A(4) of the Act to target the consultation on this
application, and it was publicly notified in accordance with section 53 of the Act.
2.4 The submission period began on 19 December 2019.
2.5 The submission period closed on 27 February 2020, in line with the statutory time frame of 30
working days.2
Response from other government agencies
2.6 The Ministry for the Environment, the Ministry of Health, the Agricultural Compounds and
Veterinary Medicines group (ACVM) of the Ministry for Primary Industries, and the Ministry of
Health were advised of the application and notified of the submission period. WorkSafe New
Zealand’s (WorkSafe) comments on this reassessment application are also included in Section
3. No other comments were received.
1 https://www.epa.govt.nz/assets/FileAPI/hsno-
ar/APP203921/APP203921_Final_Reassessment_Application_Form.pdf
2 HSNO Act s 59 (1)(c). Note working days under the Act do not include a day in the period commencing on 20
December in any year and ending with 15 January in the following year.
Staff update report for reassessment of benzyl alkonium chlorides (APP203921)
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3 Submissions
Submissions received
3.1 Two submissions were received.
3.2 The submissions in their entirety are available in the application register3 on the EPA website.
These have been summarised below, and responded to as necessary.
Datachem submission
3.3 In their submission, Datachem expressed concern with how BACs have been classified
previously. Datachem highlighted that BACs were classified inconsistently and erroneously, and
that incorrect data in the EPA chemical classification and information database (CCID) was
being used by importers and manufacturers to self-classify mixtures which contain BACs. This
results in cleaning chemicals being sold to the general public with incorrect labelling and
incorrect safety data sheets (SDS), and accordingly the general public not being aware of the
hazardous nature of the substances. Overall Datachem were in support of the classification
review, with special attention to:
making BAC classifications consistent with international findings,
making available the same information to manufacturers of hazardous substances which
contain BACs for classification of mixtures,
increasing the public’s awareness of the hazardous nature of these substances.
EPA response
3.4 The concerns raised by Datachem are noted and considered to be addressed by proceeding
with the reassessment. No information was provided in the submission which would affect the
hazard classifications proposed in the application. Accordingly, no proposed hazard
classifications are affected.
Diversey submission
3.5 Diversey submitted that they were in support of the classifications of BACs in Table 7 of the
application form (BACs with individual approvals) as these classifications align with Safe Work
Australia classifications and/or National Industrial Chemicals Notification and Assessment
Scheme (NICNAS) assessments.
3.6 Diversey was opposed to corrosivity classifications proposed for approvals for low concentration
dilutions of BACs, e.g. HSR006977, HSR005673, and HSR005672. Diversey suggested that
the corrosivity classifications for these substances were not aligned with the thresholds set out
in GHS Guidance (7th revised edition, UN New York and Geneva). Accordingly, the submitter
suggests that the substances be classified as in Table 1, where the hazard classification of
each of the approvals would be based on BAC concentration within the same approval.
3 See the files with the prefix SUBMISSION at the below link.
https://www.epa.govt.nz/database-search/hsno-application-register/view/APP203921
Staff update report for reassessment of benzyl alkonium chlorides (APP203921)
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Table 1: Suggested classifications submitted by Diversey for diluted BAC mixtures
Approval
number
Diversey’s suggested
substance identifiers
Submitted
classification
Current
substance
identifiers
Hazard classification
proposed by EPA in
the application form
HSR006977
Benzalkonium chloride, ≥
3% but < 5% in a non
hazardous diluent
6.3A, 8.3A
Benzalkonium
chloride, >1 - 5%
in a non
hazardous diluent
8.2B, 8.3A,
9.1A (all), 9.3C Benzalkonium chloride ≥
1% but < 3% in a non
hazardous diluent
6.3A, 6.4A
HSR005673
Benzyl-C12-16-
alkyldimethylammonium
chloride, ≥ 3% but < 5% in
a non hazardous diluent
6.3A, 8.3A
Benzyl-C12-16-
alkyldimethylamm
onium chloride,
>1 - 10% in a non
hazardous diluent
6.1E (all), 6.1E (oral), 8.2B, 8.3A,
9.1A (all), 9.3C Benzyl-C12-16-
alkyldimethylammonium
chloride, ≥ 1% but < 3% in
a non hazardous diluent
6.3A, 6.4A
HSR005672
Benzyl-C12-18-
alkyldimethylammonium
chloride, ≥ 3% but < 5% in
a non hazardous diluent
6.3A, 8.3A
Benzyl-C12-18-
alkyldimethylamm
onium chloride,
>1 - 10% in a non
hazardous diluent
6.1E (all), 6.1E (oral), 8.2B, 8.3A,
9.1A (all), 9.3C
Benzyl-C12-18-
alkyldimethylammonium
chloride, ≥ 1 % but < 3% in
a non hazardous diluent
6.3A, 6.4A
EPA response
3.7 The submission appears to rely on Table 3.2.3 of the UN GHS guidance (7th revised edition, UN
New York and Geneva)4 to support the proposal that the lower cut off for Skin Corrosive should
be raised to ≥5%.
3.8 In the case of Chapter 3.2, when classifying mixtures based on composition of “relevant
ingredients”, there is a table for mixtures when additivity is used (Table 3.2.3) and a table for
mixtures when using additivity is not appropriate (Table 3.2.4).
3.9 Paragraph 3.2.3.3.4 defines which “relevant ingredients” should not be assessed using
additivity. In the case of the BAC reassessment this paragraph is relevant as BAC is a
surfactant which triggers skin corrosivity (category 1).
4 See Part 3. https://www.unece.org/trans/danger/publi/ghs/ghs_rev07/07files_e.html
Staff update report for reassessment of benzyl alkonium chlorides (APP203921)
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3.10 Therefore, in mixtures containing BAC the cut off in Table 3.2.4 for “other” is relevant for the
BAC content and the mixture is skin corrosive category 1 at concentrations ≥1%.
3.11 The conclusion for the eye damage/corrosion situation is essentially equivalent to that for skin
corrosivity discussed above. Again, the submission appears to rely on Table of 3.3.3 of the UN
GHS guidance to support the proposal that the lower cut off for eye corrosive should be raised
to ≥3%.
3.12 In the case of Chapter 3.3, when classifying mixtures based on composition of “relevant
ingredients”, there is a table for mixtures when additivity is used (Table 3.3.3) and a table for
mixture when using additivity is not appropriate (Table 3.3.4).
3.13 The paragraph 3.3.3.3.4 defines which “relevant ingredients” should not be assessed using
additivity. In the case of the BAC reassessment this paragraph is relevant as BAC is a
surfactant which triggers eye damage/corrosion (category 1).
3.14 Therefore, in mixtures containing BAC the cut off in Table 3.3.4 for “other” is relevant and the
mixture is eye corrosive category 1 at concentrations ≥1%.
3.15 Both the skin and eye corrosivity classifications for the substances in Table 8 of the application
form were determined using the 1% threshold for the BAC component. Accordingly, there is no
change to the proposed hazard classifications for HSR006977, HSR005673, and HSR005672
as listed in Table 8 of the application form.
WorkSafe advice
3.16 WorkSafe provided advice relating to the work place health and safety aspects of the BAC
reassessment. This report is available in its entirety on the EPA website. Some points are
summarised below.
3.17 WorkSafe notes that changes to hazard classifications of these substances will in turn have an
effect on the controls prescribed in the Health and Safety at Work (Hazardous Substances)
Regulations 2017.
3.18 WorkSafe considers that compliance with the Health and Safety at Work (Hazardous
Substances) Regulations and Health and Safety at work (General Risk and Workplace
Management) Regulations will be adequate to reduce the risks associated with the use of these
substances in the workplace.
Staff update report for reassessment of benzyl alkonium chlorides (APP203921)
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4 Corrections to information in the application form
4.1 Two substances in Table 7 of the application form were misclassified. The acute dermal toxicity 6.1D (dermal) classification was assigned to two
substances, despite reference to an endpoint which would trigger a 6.1C (dermal) classification. This affects the overall acute toxicity classification and
associated prescribed controls referenced for HSR002952, but does not change these matters for HSR003776 which also triggers a 6.1C acute toxicity
classification via the oral route. The corrections are summarised in Table 2.
Table 2: Excerpts from Table 7 in the reassessment application with corrections
CAS Name Approval number
Current classification
Proposed classification
Justification Effect on controls
8001-54-5 Benzalkonium chloride
HSR002952 6.1C (all), 6.1C (oral), 6.1D (dermal), 8.2C, 8.3A, 6.5A, 6.5B, 6.9B (all), 6.9B (dermal), 9.1A (all), 9.1A (fish), 9.1A (crustacean), 9.1 (algae), 9.3B
6.1D (all) 6.1C (all), 6.1D (oral), 6.1D (dermal) 6.1C (dermal), 8.2B, 8.3A 9.1A (all), 9.1A (fish), 9.1A (crustacean), 9.1A (algae), 9.3B
Acute oral toxicity: LD50 = 304.5 mg/kg bw (US EPA) equivalent to 6.1D Acute dermal toxicity: LD50 = 930 mg/kg bw (NICNAS) equivalent to 6.1D 6.1C Skin irritation/corrosivity: Skin Corr. 1B (C&L Inventory5), equivalent to 8.2B Eye irritation/ corrosivity: Eye Dam. 1 (C&L Inventory5), indicates the substance is corrosive to ocular tissue equivalent to 8.3A
Remove: HPC-2 HSW13-5 No change
121-54-0 Benzethonium chloride
HSR003776 6.1C (all), 6.1C (oral), 6.1D (dermal), 6.1D (inhalation), 8.2C, 8.3A, 9.1A (all), 9.1B (fish), 9.1B (crustacean), 9.1A (algae), 9.3B
6.1C (all), 6.1C (oral), 6.1D (dermal) 6.1C (dermal), 8.2B, 8.3A 9.1A (all), 9.1A (fish), 9.1A (crustacean), 9.1A (algae), 9.3B
Acute oral toxicity: LD50 = 295 mg/kg bw (ECHA registered substances database6) equivalent to 6.1C Acute dermal toxicity: LD50 = 930 mg/kg bw (US EPA) equivalent to 6.1D 6.1C Skin irritation/ corrosivity: Study data in ECHA registered substances database6 indicates 8.2B Eye irritation/ corrosivity: Study data in ECHA registered substances database6 indicates the substance is corrosive to ocular tissue equivalent to 8.3A
No change
5 https://echa.europa.eu/information-on-chemicals/cl-inventory-database/-/discli/details/129661
6 https://echa.europa.eu/registration-dossier/-/registered-dossier/20277/
Staff update report for reassessment of benzyl alkonium chlorides (APP203921)
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5 Overall evaluation and recommendation
5.1 Taking account of the application form and the content of this report, it is considered that all
effects associated with the reassessment have been taken into account, in accordance with
section 63A(6)(a) of the Act.
5.2 It is considered that the revised proposals take into account best international practices and
standards for the safe management of hazardous substances in accordance with section
63A(6)(b) of the Act.
5.3 As a result of the above considerations, it is recommended that the decision-making committee
approves the modified reassessment, with the implementation of the proposed changes to the
hazard classifications and associated controls as set out in the application, with the
modifications described above.
Recommended