epa update report: benzyl alkonium chlorides ......staff update report for reassessment of benzyl...

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 [email protected]

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


epa.govt.nz [email protected] iii

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.

mailto:[email protected]


epa.govt.nz iv [email protected]

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


epa.govt.nz [email protected] v

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



epa.govt.nz [email protected] 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.


https://www.epa.govt.nz/assets/FileAPI/hsno-ar/APP203921/APP203921_Final_Reassessment_Application_Form.pdf

https://www.epa.govt.nz/assets/FileAPI/hsno-ar/APP203921/APP203921_Final_Reassessment_Application_Form.pdf


epa.govt.nz 2 [email protected]

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

https://www.epa.govt.nz/database-search/hsno-application-register/view/APP203921



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-




6.3A, 6.4A

HSR005672

Benzyl-C12-18-




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-


chloride, ≥ 1 % but < 3% in


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


https://www.unece.org/trans/danger/publi/ghs/ghs_rev07/07files_e.html



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.



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/


https://echa.europa.eu/information-on-chemicals/cl-inventory-database/-/discli/details/129661

https://echa.europa.eu/registration-dossier/-/registered-dossier/20277/



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.

epa update report: benzyl alkonium chlorides ......staff update report for reassessment of benzyl...

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