Implementation of GHS 7 - EPA · 2020-06-07 · Implementation of GHS 7 – Implications for hazardous substance approvals and group standards | June 2020 7 1. Executive Summary 1

Implementation of GHS 7

Implications for

hazardous substance

approvals and group

standards

Consultation Document 2

JUNE 2020

Implementation of GHS 7 – Implications for hazardous substance approvals and group standards | June 2020

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We seek public input

This document has been prepared by the Environmental Protection Authority (EPA) to inform affected

stakeholders and interested parties of proposals relating to applying the Globally Harmonized System

for Classification and Labelling of Chemicals, Revision 7 (the GHS 7).

In addition to updating all hazardous substance approvals and group standards to apply GHS 7

classifications, we are taking this opportunity to revoke a number of duplicate approvals, update the

controls on approvals issued before 1 December 2017, and make other minor amendments to a few

group standards.

These proposals are being consulted on to enable the public to comment and to provide relevant

information which will be taken into account in the decisions the EPA makes regarding this work. We

welcome your feedback.

You can make a submission online using the form available in the Public Consultations: Open for submission

area of the EPA website https://www.epa.govt.nz/public-consultations/open-consultations/GHS-

Implementation-Consultation-2/. The submission form includes the questions asked throughout this

consultation document.

If you are unable to enter your submission online, please contact us at [email protected] and we

will forward you a form to complete. You can also use this email address to ask any questions you have

on the submission process.

For more information on how to make a submission, see the consultation page on the EPA website

https://www.epa.govt.nz/public-consultations/open-consultations/.

Closing date for submissions

Please send your submissions to us no later than 5pm, 4 August 2020.

How we will consider your submissions

The EPA will review all submissions received and prepare a summary of submissions which will include

an analysis of how the comments provided have been considered. Submissions in relation to group

standards, and hazardous substance approvals to be reassessed under section 63C of the Hazardous

Substances and New Organisms Act 1996 (HSNO Act), will be considered by a decision-making

committee (DMC) appointed by the EPA.

Privacy

The Privacy Act 1993 establishes certain principles with respect to the collection, use, and disclosure of

information about individuals by various agencies, including the EPA.

Any personal information you supply when providing feedback will be used only in relation to the

matters covered by this document. We may also use your contact details for the purpose of requesting

your participation in customer surveys.

You have a right to access and correct any personal information held by us, by contacting the EPA

(contact details available https://www.epa.govt.nz/contact-information/ ).

https://www.epa.govt.nz/public-consultations/open-consultations/GHS-Implementation-Consultation-2/


mailto:[email protected]

https://www.epa.govt.nz/public-consultations/open-consultations/

https://www.epa.govt.nz/contact-information/


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You may request that your personal information (such as name and address) be withheld from publicly

available information.

Official Information

The Official Information Act 1982 (OIA) establishes principles with respect to the disclosure of

information held by government agencies, including the EPA. Any information you supply in the course

of providing feedback will be subject to the OIA and may be disclosed, upon request, to members of the

public.

Please advise if you consider that the information provided by you would fall within the grounds for

withholding information under the OIA.

If the EPA receives an OIA request that involves information marked confidential or commercially-

sensitive, we will make every effort to contact you to advise you that we have received an OIA request

and to give you an opportunity to let us know if you consider that there are grounds under the OIA to

withhold the information.

Disclaimer

The contents of this document do not reflect final EPA policy. Words and details that form part of these

proposals do not necessarily reflect settled terminology and may change in the process of drafting the

final EPA notices and group standards. This document does not alter the laws of New Zealand. All

reasonable effort has been made to ensure that the information provided in this publication is accurate,

up to date, and otherwise adequate in all respects. But this information is made available strictly on the

basis that the EPA does not accept any responsibility or liability to any person or entity that chooses to

rely on the information in this document.


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Contents

We seek public input 3

Privacy 3

Official Information 4

Disclaimer 4

1. Executive Summary 7

Structure of this document .................................................................................................10

2. Introduction 12

Background ........................................................................................................................12

This consultation document ...............................................................................................13

Proposals ...........................................................................................................................14

Māori interests....................................................................................................................15

Next steps ..........................................................................................................................15

3. Responses to the October 2019 - January 2020 consultation 16

4. Amendments to EPA notices 18

5. Updating HSNO approvals to apply GHS classifications 23

Reissuing or revoking individual substance approvals approved or reassessed before

1 December 2017...............................................................................................................23

Updating individual substance approvals approved or reassessed after 1 December 2017

...........................................................................................................................................25

Updating group standards ..................................................................................................26

6. Proposals 27

Proposal 1 – Proposed GHS classifications for all individual approvals............................27

Proposal 2 – Proposed “fate” for individual approvals .......................................................32

Proposal 3 – Proposed changes to group standards.........................................................36

Proposal 4 – Control mapping (individual approvals approved or reassessed before 1

December 2017) ................................................................................................................42

Proposal 5 – Remove requirement for signage on basis of terrestrial ecotoxicity hazards44

7. Responding to this document 46

Proposals and submission form .........................................................................................46

Hearing ...............................................................................................................................46

Posting and release of information ....................................................................................46


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Appendix 1. Glossary of Terms 47

Appendix 2. October 2019 consultation document 48

Appendix 3. Submissions analysis report from October 2019 consultation 48

Appendix 4. Exposure drafts of new and amended notices 48

Appendix 5. Proposed group standards 48

Appendix 6. Proposed classifications and fates of approved substances 48

Appendix 7. Proposed controls mapping spreadsheet 48


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1. Executive Summary

1. The Environmental Protection Authority (EPA) is updating New Zealand’s hazardous substance

classification system to apply Revision 7 (2017) of the Globally Harmonized System of Classification

and Labelling of Chemicals (GHS).

2. GHS is an internationally-agreed system developed by the United Nations (UN) to classify chemicals

and to communicate their hazards through labels and safety data sheets. Applying the GHS 7 will

ensure New Zealand has an internationally-aligned classification system that facilitates trade and

increases the effectiveness of chemicals management under the Hazardous Substances and New

Organisms Act 1996 (HSNO Act).

3. The EPA consulted on the intention to adopt GHS 7 in October 2019.

4. We are now requesting feedback on the next stage of the project which mainly involves updating

existing hazardous substance approvals and all group standards to convert their current HSNO

classifications to GHS classifications. In addition, we are taking this opportunity to revoke a number of

duplicate approvals, update the controls on approvals issued before 1 December 2017 to bring them

into line with the health and safety reforms that came into force on that date, and make other minor

changes to a few group standards.

Previous consultation

5. In October 2019, the EPA consulted on five specific proposals related to adopting GHS 7:

(1) to update the existing HSNO classification system by issuing a new EPA Hazard

Classification Notice that would incorporate the new GHS classification criteria

(2) regarding the GHS 7 building blocks, to:

not adopt acute toxicity Category 5 (HSNO 6.1E)

not adopt skin irritation Category 3 (HSNO 6.3B)

not adopt aspiration hazard Category 2

adopt all seven categories for aquatic toxicity, i.e. Acute 1–3 and Chronic 1–4

(HSNO 9.1A–D).

(3) to adopt the lower GHS 7 concentration cut-off values for the classification of mixtures

(4) to replace the current HSNO classification subclasses for terrestrial ecotoxicity (9.2, 9.3 and

9.4) and 9.1D biocides with a classification category “substances that are ecotoxic to the

terrestrial environment”, and to apply this classification only to agrichemicals and related

substances

(5) to include an additional two-year transitional period in the EPA Labelling, Safety Data

Sheets, and Packaging Notices to allow those impacted to make the necessary changes

resulting from updating to GHS 7 and the re-issuing of approvals.


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6. Our recommendations on these five proposals, which include some changes to the original proposals,

are summarised in section 3 of this document. A summary of the submissions received in response to

the October 2019 consultation, and a more detailed discussion on the recommendations and the

rationale supporting these, is provided in our submissions analysis report which is available in

Appendix 3.

7. Following our review of the submissions, the EPA proposes to progress with implementing GHS 7.

This will be achieved by issuing a new Hazard Classification Notice and revoking the current

Classification Notice, and Minimum Degrees of Hazard Notice. Consequential amendments will also

be made to the Labelling, Safety Data Sheets, Packaging, Disposal, Hazardous Property Controls and

Importers and Manufacturers Notices. These consequential amendments were described in the

October 2019 consultation document, and are further discussed in section 4 of this document.

Exposure drafts of the new Hazard Classification Notice, and the six amended notices are available in

Appendix 4. These drafts are being made available for information only, with the exception that we are

seeking feedback on one proposed change to the Hazardous Property Controls Notice (refer to

Proposal 5 in section 6).

8. The proposed date for the new Hazard Classification Notice and six amended notices to come into

force is April 2021. However, a transitional period of four years is proposed for the Labelling, Safety

Data Sheets, and Packaging Notices, meaning that compliance with these three notices will not be

mandatory for existing hazardous substance approvals or group standards until April 2025. Despite

this transitional period, we strongly advise companies to comply earlier if possible so that the benefits

of aligning internationally are achieved.

Proposals included in this current consultation

9. A consequence of adopting GHS 7 is that all HSNO hazardous substance approvals need to be

updated to assign GHS 7 classifications as will be provided for in the new Hazard Classification

Notice. There are three types of approvals that need to be updated:

individual approvals approved or reassessed before 1 December 20171

individual approvals approved or reassessed after 1 December 2017

group standards reissued on or after 1 December 2017.

10. As part of this update process, we are planning to revoke 5,628 individual approvals as they are

covered by one or more group standards, meaning their individual approval is redundant2.

1 On this date many workplace controls were transferred out of the HSNO regime to the new Health and Safety at

Work (Hazardous Substances) Regulations.

2 The legal mechanism to revoke redundant approvals is provided by section 67B of the HSNO Act.


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11. We also intend to update the controls placed on substances approved before 1 December 2017 to

take account of the health and safety reforms implemented on this date.

12. This consultation document is seeking feedback on five proposals:

proposed GHS 7 classifications for all individual hazardous substance approvals, including

those that we are planning to revoke.

proposed “fate” of all individual hazardous substance approvals, i.e. whether we plan to

revoke or retain the approval. For each individual approval we propose to revoke, we will

identify which group standard(s) we consider could be used to manage that substance.

proposed changes to the group standards to apply the GHS 7 classifications.

updates to the controls placed on substances approved or reassessed before

1 December 2017.

to amend the Hazardous Property Controls Notice to no longer require signage for

agrichemicals on the basis of their terrestrial ecotoxicity hazards.

13. This consultation covers all hazardous substance approvals (other than containment or transhipment

approvals) in effect as of 1 January 2020. Approvals (including reassessment approvals) issued by the

EPA after this date are not included in this consultation and will be the subject of a later reassessment

under section 63C of the HSNO Act to apply the GHS 7 classifications.

Next steps

14. Submissions on the proposals included in this consultation document should be lodged with the EPA

by 5pm on 4 August 2020 to ensure your views can be taken into account in the EPA’s decisions

regarding this work.

15. At the close of the consultation period, the EPA will review each submission and prepare a

submissions analysis report. This report will provide a summary of the key themes of the submissions,

and our recommendations, taking into account the comments received. The report will be published on

the EPA website.

16. A decision-making committee (DMC) will be appointed and will review the submissions analysis report

and the EPA’s recommendations. The DMC will be asked to decide whether:

the individual approvals approved or reassessed after 1 December 2017 should be

updated under section 63C of the HSNO Act with the GHS 7 classifications proposed

the group standards should be revoked and new group standards issued as proposed

17. A hearing will be held if the DMC considers it is necessary, or if a submitter has asked to be heard.

18. Should we progress with the proposals in this consultation document, we would update all existing

HSNO approvals to convert their HSNO classifications to the GHS 7 classifications. This would entail:


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reissuing all individual hazardous substance approvals approved before 1 December 2017

to apply the GHS 7 classifications and to update their HSNO controls

updating all individual hazardous substance approvals approved after 1 December 2017 to

apply the GHS 7 classifications

revoking the redundant individual approvals which are covered by one or more group

standards

issuing a new set of group standards to apply the GHS 7 classifications and revoking the

existing 2017 group standards

19. These proposals would be taken forward alongside those described in the October 2019 consultation

document, and in line with the recommendations made following the close of that consultation,

including:

issuing a new Hazard Classification Notice and revoking the current Classification Notice

and Minimum Degrees of Hazard Notice

making consequential amendments to the Labelling Notice, Safety Data Sheets Notice,

Packaging Notice, Disposal Notice, Hazardous Property Controls Notice and Importers and

Manufacturers Notice.

Structure of this document

20. This document has been split into several parts:

Section 3. Recommendations following the October 2019 consultation

Section 4. Amendments to EPA notices

Section 5. Updating HSNO approvals to apply GHS classifications

o Reissuing or revoking individual substance approvals approved or reassessed before

1 December 2017

o Updating individual substance approvals approved or reassessed after 1 December 2017

o Updating group standards

Section 6. Proposals

o Proposal 1 – Proposed GHS classifications for all individual approvals

o Proposal 2 – Proposed “fate” for individual approvals

o Proposal 3 – Proposed changes to group standards

o Proposal 4 – Control mapping (individual approvals approved or reassessed before

1 December 2017)

o Proposal 5 – Remove requirement for signage on basis of terrestrial ecotoxicity

hazards

Section 7. Responding to this document


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Appendices:

o Appendix 1. Glossary of terms

o Appendix 2. October 2019 consultation document

o Appendix 3. Submissions analysis report from October 2019 consultation

o Appendix 4. Exposure drafts of new and amended notices

- Hazard Substances (Hazard Classification) Notice 2020 (new)

- Hazard Substances (Labelling) Notice 2017 (amended)

- Hazard Substances (Safety Data Sheets) Notice 2017 (amended)

- Hazard Substances (Packaging) Notice 2017 (amended)

- Hazard Substances (Disposal) Notice 2017 (amended)

- Hazard Substances (Hazardous Property Controls) Notice 2017 (amended)

- Hazard Substances (Importers and Manufacturers) Notice 2015 (amended)

o Appendix 5. Proposed group standards

o Appendix 6. Proposed classifications and fates of approved substances

o Appendix 7. Proposed controls mapping spreadsheet


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2. Introduction

21. This consultation document has been prepared to seek comments on the next stage of the EPA’s work

to adopt GHS 7. Proposals are put forward to update existing hazardous substance approvals and all

group standards to apply the GHS 7 classifications as set out in the new Hazard Classification Notice.

In addition, we are taking this opportunity to revoke a number of duplicate approvals, update the

controls on approvals issued before 1 December 2017, and make other minor changes to a few group

standards.

22. This document has been published on our website and sent to interested parties including the Ministry

for the Environment, the Ministry of Business, Innovation and Employment, WorkSafe, the Ministry of

Health, the Ministry for Primary Industries, and Customs.

Background

23. Hazardous substances in New Zealand are managed under several pieces of legislation with one of

the key ones being the Hazardous Substances and New Organisms Act 1996 (HSNO Act). The HSNO

Act sets the criteria that defines a substance as hazardous and provides a framework to assign

particular hazard classifications to those substances.

24. The hazard classification determines the nature and level of the controls that are placed on a

substance to manage any risks associated with those hazards. Many of these controls are set under

HSNO such as controls on importers and manufacturers at the top of the supply chain (e. g labelling,

safety data sheets, packaging controls), controls to protect the environment, controls on the disposal

of hazardous substances and controls to protect people in non-workplaces. Most HSNO controls are

set in EPA notices3.

25. Controls to manage the risks to people from hazardous substances used in the workplace are set

under the Health and Safety at Work Act 2015 (HSW Act), primarily in the HSW (Hazardous

Substances) Regulations and HSW (Major Hazardous Facilities) Regulations.

26. The GHS is an internationally-agreed system developed by the UN to classify chemicals based on

their physical, health and environmental hazards and to communicate their hazards through labels and

safety data sheets. The GHS was first published in 2003 and has been revised every two years since

then.

27. The current HSNO classification framework, implemented in 2001, was based on a pre-published

version of GHS and has not been updated since that time.

28. From October 2019 to January 2020, the EPA consulted on a proposal to adopt GHS 7. The

consultation sought comments on five specific proposals. Seventy-one submissions were received.

3 https://www.epa.govt.nz/industry-areas/hazardous-substances/rules-for-hazardous-substances/epa-notices-for-

hazardous-substances/

https://www.epa.govt.nz/industry-areas/hazardous-substances/rules-for-hazardous-substances/epa-notices-for-hazardous-substances/

https://www.epa.govt.nz/industry-areas/hazardous-substances/rules-for-hazardous-substances/epa-notices-for-hazardous-substances/


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29. Our recommendations on moving forward with these proposals are summarised in section 3 of this

document. A summary of submissions and a detailed discussion on the recommendations and the

rationale supporting these, is provided in the submissions analysis report which is available in

Appendix 3.

30. Following an analysis of the submissions received, we are proposing to proceed with implementing

GHS 7. This will be achieved by:

revoking the current Minimum Degrees of Hazard Notice 2017 and Classification Notice 2017 and

issuing a new Hazard Classification Notice 2020 that will incorporate the new GHS 7 classification

criteria by reference to the corresponding sections of the GHS 7 document.

31. Consequential amendments to give effect to the new Hazard Classification Notice will be made to the

other EPA notices, including the Labelling, Safety Data Sheets, Packaging, Disposal, Hazardous

Property Controls, and Importers and Manufacturers Notices.

This consultation document

Updating approvals to apply GHS

32. A consequence of adopting GHS 7 is that all hazardous substance approvals need to be updated to

convert their existing HSNO classifications to GHS 7 classifications. This consultation document seeks

feedback on the EPA’s proposals relating to updating these approvals.

33. There are three types of approvals that need to be updated:

individual approvals approved or reassessed before 1 December 20174 (8,935 approvals).

Note the controls on these approvals also need to be updated to take account of the health

and safety reforms that came into force on 1 December 2017 (refer to paragraph 35).

individual approvals approved or reassessed after 1 December 2017 (138 approvals as of

1 January 2020)

group standards reissued on or after 1 December 2017 (208 group standards)

34. As part of the update process, we plan to revoke 5,628 of the 9,073 approvals as they are covered by

one or more group standards meaning their individual approval is redundant.

4 On this date many workplace controls were transferred out of HSNO to the new HSW (Hazardous Substances)

Regulations.


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Updating controls for approvals approved before 1 December 2017

35. New Zealand's health and safety system was significantly reformed in 2015 by the enactment of the

Health and Safety at Work Act 2015. On 1 December 2017, the HSW (Hazardous Substances)

Regulations came into force. Many workplace controls were transferred out of HSNO into these new

regulations. At the same time, many existing HSNO regulations were revoked and replaced by EPA

notices.

36. As a result of these regulatory changes, the controls listed in the approval documents of hazardous

substances approved before 1 December 2017 are no longer reflective of the current regulatory

requirements. As noted in paragraph 33, there are 8,935 such approvals, 5,623 of which we are

planning to revoke. The remaining 3,312 will be reissued to:

remove any HSNO workplace controls that were transferred to the HSW (Hazardous

Substances) Regulations on 1 December 2017

remove any HSNO controls that require compliance with the now revoked HSNO

regulations and instead require compliance with the new EPA notices

retain any HSNO section 77 or 77A control variations as relevant.

Proposals

37. The proposals on which we are specifically seeking your feedback are listed in Table 1 below:

Table 1. List of proposals

Proposal no. Proposal Reference

Proposal 1 To assign proposed GHS 7 classifications to all

individual hazardous substances approved or

reassessed before 1 January 2020, including those that

we are planning to revoke.

Refer to section 6 and

Appendix 6 (Classifications

and Fates spreadsheet)

Proposal 2 To propose “fates” (retain or revoke the approval) for all

individual hazardous substances approved or

reassessed before 1 January 2020.

Note for those individual approvals we plan to revoke,

we have included the name and approval number of the

relevant group standard(s) under which the substance

can be managed.


Appendix 6 (Classifications

and Fates spreadsheet)

Proposal 3 To update the 208 group standards to apply GHS 7

classification, and make minor changes to a few group

standards.


Appendix 5 (proposed group

standards)


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Proposal no. Proposal Reference

Proposal 4 To update the controls placed on substances approved

or reassessed before 1 December 2017 to take account

of the health and safety reforms implemented on

1 December 2017.


Appendix 7 (controls

mapping spreadsheet)

Proposal 5 To amend the Hazardous Property Controls Notice to

no longer require signage for agrichemicals on the

basis of their terrestrial ecotoxicity hazards.


Appendix 4 (exposure draft

of amended Hazardous

Property Controls Notice)

Māori interests

38. Having a robust, internationally-aligned classification system in Aotearoa to help protect people,

communities and the environment from the adverse effects of hazardous substances is consistent with

Māori environmental values and frameworks.

39. Our October 2019 consultation document was sent to Te Herenga, the EPA’s national network of

Māori environmental practitioners and kaitiaki. We are providing this consultation document to the

same network.

Next steps

40. When this consultation closes, the EPA will review each written submission and prepare a summary of

submissions. This summary will be available to all submitters and placed on our website. Submissions

in relation to group standards, and approvals to be reassessed under section 63C of the HSNO Act,

will be considered by a decision-making committee (DMC) appointed by the EPA.


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3. Responses to the October 2019 - January 2020 consultation

41. The October 2019 consultation document included five proposals associated with implementing

GHS 7. This first consultation document is available in Appendix 2.

42. Taking into account the comments received, the EPA has prepared recommendations on each of the

proposals. These are summarised in Table 2 below. A more detailed description of the proposals and

our rationale for each recommendation is provided in the submissions analysis report, available in

Appendix 3.

43. Our recommendations on the proposals included in the October 2019 consultation document will be

considered by the EPA Board when it meets to issue the relevant EPA notices later this year

(discussed in section 4 below).

Table 2. Summary of EPA recommendations on proposals in October 2019 consultation document

Proposal (October 2019 consultation document) EPA recommendation

To update the HSNO classification system by issuing a

new EPA Hazard Classification Notice that will

incorporate the GHS revision 7 by reference.

To progress with this proposal.

Regarding what building blocks to adopt, we proposed:

To not adopt acute toxicity Category 5 (HSNO

6.1E) (Proposal 2a)

To not adopt skin irritation Category 3 (HSNO

6.3B) (Proposal 2b)

To not adopt aspiration hazard Category 2

(Proposal 2c)

To adopt all seven categories for aquatic toxicity,

i.e. acute Categories 1–3 and chronic Categories

1–4 (which cover HSNO 9.1A–D) (Proposal 2d)

To progress with Proposal 2a as proposed.

To not adopt acute toxicity Category 5 (HSNO 6.1E)

To progress with Proposal 2b as proposed.

To not adopt skin irritation Category 3 (HSNO 6.3B)

To progress with Proposal 2c as proposed.

To not adopt aspiration hazard Category 2

To not progress with Proposal 2d as proposed.

We now recommend to not adopt aquatic toxicity

acute Categories 2 and 3, but adopt the other five

categories (i.e. acute Category 1 and chronic

Categories 1-4)

Where the GHS 7 provides for optional concentration

cut-off values for classification of mixtures, we proposed

to adopt the lower concentration cut-off values.

To progress with Proposal 3 as proposed.

To adopt the lower concentration cut-off values for

classification of mixtures.


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Proposal (October 2019 consultation document) EPA recommendation

To replace the current HSNO subclasses for

terrestrial ecotoxicity (9.2, 9.3 and 9.4) and 9.1D

biocides with a single category “substances that are

ecotoxic to the terrestrial environment” and to only

apply that classification category to agrichemicals and

related substances.

To progress with a slightly modified Proposal 4.

Specifically the new Hazard Classification Notice will

include a classification category “substances that are

hazardous to the terrestrial environment”. This category

will be subcategorised into:

hazardous to soil organisms

hazardous to terrestrial vertebrates

hazardous to terrestrial invertebrates

designed for biocidal action

These classifications will be applied only to agrichemicals,

and active ingredients used in the manufacture of

pesticides and veterinary medicines.

The current classification criteria for the 9.2, 9.3 and 9.4

categories will not be used. However, we are proposing to

retain the threshold criteria for ecotoxicity to soil

organisms, terrestrial vertebrates and terrestrial

invertebrates that are currently contained in the

Hazardous Substances (Minimum Degrees of Hazard)

Notice 2017. These criteria will be included in the new

Hazard Classification Notice.

To extend by two years the current transitional period

in the EPA Labelling Notice, Safety Data Sheets

Notice, and Packaging Notice, i.e. to implement a

transitional period for these notices that would expire

on 1 December 2023.

To extend the transitional period proposed in the

consultation document. We now propose to implement a

four year transitional period for compliance with the

Labelling Notice, Safety Data Sheets Notice, and

Packaging Notice starting from the date of GHS

implementation. With an intended implementation date of

April 2021, the transitional period would expire in April

2025. With the lead-in time industry has had regarding the

EPA’s intention to implement GHS, we consider this will

give industry ample time to design and prepare compliant

labels and safety data sheets.


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4. Amendments to EPA notices

44. EPA notices are legally binding regulatory instruments that are approved by the EPA Board. The

statutory requirements under section 76C of the HSNO Act for issuing and amending EPA notices

were included in the October 2019 consultation document. This included a description of the

anticipated costs and benefits of adopting GHS 7 and consideration of international best practices.

45. The current HSNO classification system is implemented via two EPA notices, the Minimum Degrees of

Hazard Notice and the Classification Notice. Implementing GHS 7 will be achieved by issuing a new

Hazard Classification Notice. The Minimum Degrees of Hazard Notice 2017 and current Classification

Notice 2017 will be revoked.

46. An exposure draft of the new Hazard Classification Notice was included in our October 2019

consultation document. That consultation document also included an indication of the consequential

amendments required to six other EPA notices as a result of implementing GHS 7, notably the

Labelling, Safety Data Sheets, Packaging, Disposal, Hazardous Property Controls, and Importers and

Manufacturers Notices.

47. Exposure drafts of the new Hazard Classification Notice5 and the six amended notices are provided in

Appendix 4. For each amended notice two documents are provided, a “clean” version and a second

version in tracked changes to indicate all proposed modifications, additions and deletions.

48. The consequential amendments mainly involve replacing the references to the existing HSNO

classifications with the GHS 7 classifications. However, for some notices, primarily the Labelling

Notice and the Hazardous Property Controls Notice, more significant changes to some clauses are

required to reflect GHS 7 becoming the new classification system. These are mainly due to changes to

the terrestrial ecotoxicity classifications and the proposal to apply these classifications only to

agrichemicals, and active ingredients used in the manufacture of pesticides and veterinary medicines.

49. One of the changes proposed to the Hazardous Property Controls Notice is significant enough that we

are seeking feedback on it (refer to Proposal 5). Other than this proposed amendment, we are not

formally requesting feedback on the other consequential changes to the EPA notices as a result of

adopting GHS 7. This opportunity was provided for in the October 2019 consultation document. The

exposure drafts of the EPA notices available in Appendix 4 are provided for information only.

50. Any other amendments to the notices that require policy changes will be the subject of future

consultations.

5 Note that we are now proposing to adopt the sub-categories for skin sensitisation Category 1a and 1b and respiratory

sensitisation Category 1a and 1b.


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51. A summary of the key changes to the EPA notices is provided in Table 3 below.

Table 3: Summary of changes required for EPA notices

EPA notice Summary of changes

Minimum Degrees of

Hazard Notice 2017

Notice to be revoked

Classification Notice 2017 Notice to be revoked

Hazard Classification

Notice 2020

New Hazard Classification Notice 2020 to be issued to give effect to the GHS 7

hazard classes/classifications.

Labelling Notice 2017 Notice to be amended to:

replace occurrences of existing HSNO classes/classifications with GHS 7

classes/classifications with minor changes to wording in relevant clauses and

tables as required.

remove clause on labelling elements for desensitised explosives as these are

now included within GHS 7.

replace the term “pesticide” and associated definition with the term

“agrichemical” and associated definition.

amend clauses relating to the labelling of agrichemicals to:

o take into account that the term “agrichemicals” is now used, which

covers a wider range of substances than the current term “pesticides”.

o reflect the new terminology for substances that are hazardous to the

terrestrial environment.

o include performance based requirements for the labelling of

agrichemicals that are hazardous to the terrestrial environment

(clause 19), which are equivalent to those that applied under the

Hazardous Substances (Identification) Regulations 2001.

make minor changes to improve consistency and readability.

make changes to transitional provisions.

remove the Schedule that provides the HSNO to GHS classification

correlations table as this is now included in the Hazard Classification Notice

2020.


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Safety Data Sheets Notice

2017

Notice to be amended to:

replace occurrences of existing HSNO classifications with GHS 7

classifications with minor changes to wording in relevant clauses and tables

as required.

make minor amendments to reflect GHS 7 becoming the new HSNO

classification system.

make minor changes to improve consistency and readability.


remove Schedule 2 that provides the HSNO to GHS classification correlations

table as this is now included in the Hazard Classification Notice 2020.

Packaging Notice 2017 Notice to be amended to:

replace occurrences of existing HSNO classifications with GHS 7

classifications with minor changes to wording in relevant clauses and tables

as required.


Disposal Notice 2017 Notice to be amended to:


classes/classifications, with minor changes to wording in relevant clauses as

required.

replace the term “packaging” with “container” in several clauses.

amend clause 9 (2)(b) to exclude skin and eye irritants.

add a definition of “bioaccumulative” by cross-referring to the definition in

Chapter 4.1, Table 4.1.1, Note 5 of the GHS Book.

change the definition of “rapidly degradable” to cross-refer to the definition in

Chapter 4.1, section 4.1.2.11.3 of the GHS Book.

Hazardous Property

Controls Notice 2017



classes/classifications with consequential changes to wording in relevant

clauses and tables as required.

replace the term “pesticide” and associated definition with the term

“agrichemical” and associated definition.

amend clauses related to the use of agrichemicals to:

o take into account that the term “agrichemicals” is now used, which

covers a wider range of substances than the current term “pesticides”.

o reflect the new terminology for substances hazardous to the terrestrial

environment.


21


delete the default qualification requirement for people applying class 9.2A,

9.3A and 9.4A agrichemicals. This requirement will now be added as an

additional control as relevant when an agrichemical that is hazardous to the

terrestrial environment is approved. All currently approved agrichemicals

that trigger the existing the qualification requirements solely on the basis of

their 9.2A, 9.3A and/or 9.4A classifications will be added to either Table 1 or

Table 3 of Schedule 9 of the Hazardous Property Controls Notice as

appropriate to maintain the status quo.

The default qualification requirements for people applying agrichemicals

classified as aquatic toxicity acute Category 1 or chronic Category 1 will be

retained.

delete the default requirement to keep a record of application when applying

class 9.2A, 9.3A and 9.4A agrichemicals. This requirement will now be

added as an additional control as relevant when an agrichemical that is

hazardous to the terrestrial environment is approved. All currently approved

agrichemicals that trigger the existing requirement solely on the basis of

their 9.2A, 9.3A and/or 9.4A classifications will be added to a new schedule

to the Hazardous Property Controls Notice to maintain the status quo

The default requirement to keep a record when applying agrichemicals

classified as aquatic toxicity acute Category 1 or chronic Category 1 will be

retained.

propose a change to the current signage requirement (clause 43). If this

proposal goes ahead, signage will no longer be triggered on the basis on

terrestrial ecotoxicity hazards (refer to Proposal 5 in section 6).

make minor changes to improve consistency, readability and correct any

obvious errors.

Importers and

Manufacturers Notice 2017


amend clause 10 (Information and certification requirements prior to

uplifting imported hazardous substances) to take account of GHS

terminology for explosive substances.

Timing of new notices coming into force

52. If the EPA Board approves the new Hazard Classification Notice, and six amended notices as

recommended, these will be issued later this year. The intention is for them to come into force in April

2021. However, we will publish these notices on our website later this year to provide all parties with

sufficient time to view them before they come into force.


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Transitional provisions

53. Taking into account submissions received on Proposal 5 in the October 2019 consultation document6,

a four year transitional period has been included in the Labelling Notice, Safety Data Sheets Notice,

and Packaging Notice. This means that for substances with an approval that is in force before the

date of GHS implementation (at this stage proposed to be April 2021), compliance with these three

notices will not be mandatory until April 2025. However, we strongly advise companies to comply

earlier if possible so that the benefits of aligning internationally are achieved. No transitional period will

be applied to the other EPA notices.

54. Substances approved after the date of GHS implementation, including reassessments, will be required

to comply with all EPA notices immediately upon approval.

6 The October 2019 consultation document is available in Appendix 2.


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5. Updating HSNO approvals to apply GHS classifications

55. As a consequence of adopting GHS 7, all EPA hazardous substance approvals need to be updated to

convert their current HSNO classifications to GHS 7 classifications. Three types of approvals need to

be updated:

individual approvals approved or reassessed before 1 December 20177

individual approvals approved or reassessed after 1 December 2017

group standards reissued on or after 1 December 2017.

56. The legal mechanism and process for updating each of these types of approvals is discussed further

below.

57. Note that we are not re-issuing containment approvals and transhipment approvals at this time. These

approvals are specific to certain individuals and companies and we will update these approvals after

communication with these parties.

Reissuing or revoking individual substance approvals approved or reassessed before 1 December 2017

58. There are 8,935 individual approvals8 that were approved or reassessed before 1 December 2017.

This was the date that the new health and safety regime came into force and which resulted in many

HSNO workplace controls being transferred out of HSNO into the new Health and Safety at Work

(HSW) legislation.

59. The approvals for these substances have not yet been reissued to bring their controls into line with the

new health and safety reforms of 1 December 2017. This update and reissue would need to occur

irrespective of any change in classification system. However, due to the timing of this current proposal

to update to GHS 7, the updating of controls and classification will be carried out at the same time.

60. The legal mechanism to reissue the approvals for substances approved or reassessed before

1 December 2017 is clause 4 of Schedule 7 of the HSNO Act. This Schedule gives the EPA one

opportunity to reissue these approvals to align them with the new health and safety regime without the

need to conduct a formal reassessment.

7 On this date many workplace controls were transferred out of HSNO to the new HSW (Hazardous Substances)

Regulations.

8 Approximately 7,200 of these substances were transferred into the HSNO regime between July 2001 and July

2006. The remainder are substances that were approved under Part 5 of the HSNO Act between July 2001 and

1 December 2017.


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61. Reissuing these approvals will:

update their classification to GHS 7 (refer to Proposal 1)

update their controls (refer to Proposal 4) to:

o remove any HSNO workplace controls that were transferred to the HSW (Hazardous


o remove any HSNO controls that require compliance with the now revoked HSNO


o retain any HSNO section 77 or 77A control variations as relevant.

62. Many of these hazardous substance approvals are effectively redundant as the substances are able to

be managed under one or more group standards. The reason for this duplication is that many

substances were individually approved before the EPA issued the initial suites of group standards in

2006. If the group standards had been issued a few years earlier, many of these individual approvals

would not have been issued.

63. We propose to revoke 5,623 of these redundant individual approvals. These comprise:

approximately 5,150 substances that were transferred to HSNO between July 2001 and

July 2006 in a series of Gazette (Transfer) Notices

approximately 470 substances that were approved under Part 5 of the Act between

July 2001 and 1 December 2017. Many of these are veterinary medicines that fit within the

scope of one of the three Veterinary Medicine group standards established in 2012.

64. The legal mechanism to revoke redundant individual approvals is provided by section 67B of the

HSNO Act. Section 67B allows the EPA to revoke an approval if the EPA is satisfied that a

corresponding approval9 to the same or substantially similar effect applies to the substance.

65. Where a decision is made to revoke an approval, it is proposed that revocation would take effect in

April 2021. In advance of this date, the EPA will publish the list of approvals to be revoked to provide

all parties with sufficient time to view the list before these approvals are legally revoked.

66. The remaining 3,312 individual approvals will be retained and reissued. Refer to Proposal 2 for further

discussion on how the EPA determined the “fates” of all individual approvals, including the criteria

used to make this determination.

67. A new approvals document will be issued for each reissued approval. This document will contain the

substance’s new GHS 7 classification and provide a list of all the HSNO controls that apply to the

reissued substance. It will also include the substance’s HSNO approval number, which will remain

unchanged. There will also be reference to relevant controls under the HSW (Hazardous Substances)

Regulations.

9 A corresponding approval must either be issued under Part 5 of the HSNO Act or be a group standard.


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Updating individual substance approvals approved or reassessed after 1 December 2017

68. Approvals issued after 1 December 2017 were issued under the new health and safety regime, i.e.

they needed to comply with the new EPA notices and HSW Hazardous Substances Regulations

immediately upon their approval rather than the old HSNO Regulations. However, they were classified

according to the existing HSNO classification system and therefore need to be updated to convert their

HSNO classifications to GHS 7 classifications (refer to Proposal 1).

69. This consultation covers the 138 individual approvals that were approved or reassessed between

1 December 2017 and 1 January 2020. We propose to retain 133 of these approvals, and revoke five

that we consider can be managed under a group standard.

70. Any new approvals issued or reassessed between 1 January 2020 and the date of GHS 7

implementation (at this stage proposed to be April 2021) will have their classifications updated prior to

GHS 7 implementation by a modified reassessment under section 63C.

71. The legal mechanism to assign GHS 7 classifications to substances approved or reassessed after

1 December 2017 is a modified reassessment as provided by section 63C of the HSNO Act. Section

63C(5) requires the EPA to:

do everything reasonably practicable on its part to consult with all persons who, in its

opinion, may be affected by the reassessment; and

give those persons a reasonable opportunity to make submissions and comments to the

Authority on the reassessment; and

consider all submissions and comments received.

72. Once public submissions are received, these will be considered by a decision-making committee

(DMC). The DMC is appointed for the purpose of assessing the approvals to be reassessed under

section 63C, and is given the powers the EPA has under the HSNO Act to reach a decision on

whether the approvals should be issued with the proposed classifications.

73. As part of the decision-making process, the DMC will also decide whether a hearing will be held in

relation to the reassessed approvals. This will depend on whether the DMC considers a hearing to be

necessary or whether a submitter has asked to be heard in the matter.

74. The DMC will then consider all the information before it, taking into account the matters in section 63C,

before making a determination.

75. A new approvals document will be issued for each updated approval. This document will contain the

substance’s new GHS 7 classification, and provide a list of all the HSNO controls that apply to that

substance. It will also include the substance’s HSNO approval number, which will remain unchanged.

There will also be reference to relevant controls under the HSW (Hazardous Substances) Regulations.


26

Updating group standards

76. The EPA reissued 208 group standards in 2017 to bring their controls into line with the new health and

safety regime, i.e. any substances covered by a group standard are now required to comply with the

new EPA notices, including the transitional provisions in those notices.

77. In order to implement the GHS 7 classifications, these reissued group standards now need to be

updated to replace their current HSNO classifications with GHS 7 classifications (refer to Proposal 3).

78. The legal mechanism to achieve this is provided by section 96B(4) of the HSNO Act which allows the

EPA to issue, amend or revoke a group standard either on its own initiative, or on application by any

person.

79. Public submissions will be considered by a DMC appointed for the purpose of assessing the proposed

group standards. It is given the powers the EPA has under the HSNO Act to reach a decision on

whether the group standards should be revoked and new group standards issued as proposed.

80. As part of the decision-making process, the DMC will also decide whether a hearing will be held in

relation to the proposed group standards. This will depend on whether the DMC considers a hearing to

be necessary or whether a submitter has asked to be heard in the matter.

81. The DMC will then consider all the information before it, taking into account the matters in sections

96B and 96C of the HSNO Act, before making a decision.

82. The proposed group standards are available in Appendix 5.


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6. Proposals

Proposal 1 – Proposed GHS classifications for all individual approvals

Proposal 1

To assign proposed GHS 7 classifications to all individual hazardous substances approved or

reassessed before 1 January 2020, including those that we are planning to revoke.

Background and rationale

83. The current HSNO hazard classification system is prescribed in the Minimum Degrees of Hazard

Notice and Classification Notice. This framework is based on a pre-published version of GHS and

comprises:

numbered classes indicating the intrinsic hazardous property of a substance

numbered subclasses indicating the type of hazard within that class of hazardous property

lettered categories indicating the degree of hazard of a substance.

84. To implement GHS 7, the current HSNO alpha-numeric numbering system will be discontinued and all

individual hazardous substance approvals will be updated to convert their current HSNO

classifications to GHS 7 classifications. This will be done for all individual approvals regardless of

when they were approved, including those we are proposing to revoke.

85. As discussed in Table 2 in Section 3, we are proposing to not adopt certain GHS building blocks,

notably acute toxicity Category 5, skin irritation Category 3, and aquatic toxicity acute Category 2 and

Category 3. As a result:

some substances have lost classification(s)

some substances are no longer hazardous under HSNO.

Process to map HSNO to GHS classifications

86. A correlation table showing the relationship between the current HSNO classifications and GHS 7

classifications is provided in Schedule 2 of the Hazard Classification Notice (refer to Appendix 4 for the

exposure draft of the new Hazard Classification Notice).

87. As the correlation table shows, the majority of HSNO classifications have a direct 1:1 correlation with

GHS 7 classifications. Assigning GHS 7 classifications in most cases was therefore straightforward. A

1:1 correlation exists for the following HSNO classifications:

Explosives substances (class 1)

Flammable aerosols of subclass 2.1.2

Flammable liquids of subclass 3.1


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Flammable solids in the subclasses flammable solid (4.1.1), self-reactive substances

(4.1.2), spontaneously combustible substances (4.2B and C), and solids that emit a

flammable gas when in contact with water (4.3)

Oxidising gases (class 5.1.2)

Organic peroxides (class 5.2)

Toxic substances in the subclasses skin irritation (6.3), eye irritation (6.4), skin and

respiratory sensitisation (6.5), mutagenicity (6.6), carcinogenicity (6.7), and

reproductive/developmental toxicity (6.8)

Corrosive substances (class 8).

88. However, there are a few classifications where there is not a direct 1:1 correlation between HSNO and

GHS 7. These are listed in Table 4 below, along with our approach for assigning GHS 7 classifications

in these cases.

89. In addition, a few classifications exist in GHS but there is no corresponding classification in HSNO.

These classifications are:

unstable explosives

non-flammable aerosols

gases under pressure.

Table 4. List of classifications that do not have a 1:1 HSNO:GHS correlation

HSNO classification GHS classification

Flammable gases (sub-class 2.1.1) The relevant GHS flammable gas classification was

assigned based on the HSNO classification and also

taking into account available information such as the

flammability range of the substance in air.

Liquid and solid desensitised explosives (sub-classes

3.2 and 4.1.3)

The relevant GHS classification was assigned “by

analogy” with the UN Transport of Dangerous Goods

classifications.

Pyrophoric liquids and solids (4.2A) Physical state information was used to determine

whether classification as a pyrophoric liquid or

pyrophoric solid is appropriate.

Oxidising liquids and solids (5.1.1) Physical state information was used to determine

whether classification as an oxidising liquid or an

oxidising solid is appropriate.


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HSNO classification GHS classification

Acute toxicity (subclass 6.1) The HSNO Category for acute toxicity directly

correlates to the GHS Category for acute toxicity, i.e:

HSNO 6.1A maps to GHS Category 1

HSNO 6.1B maps to GHS Category 2

HSNO 6.1C maps to GHS Category 3

HSNO 6.1D maps to GHS Category 4.

Supporting information that was used in the original

classification of substances was reviewed to

determine the appropriate exposure route and where

a 6.1E substance should be classified as aspiration

hazard or specific target organ toxicity – Category 3.

Specific target organ toxicity (sub-class 6.9) The HSNO Category for specific organ target toxicity

(STOT) exposure directly correlates to the GHS

Category, i.e. HSNO 6.9A maps to GHS Category 1

and HSNO 6.9B maps to GHS Category 2.

However, the HSNO 6.9 classification does not have

separate categories for repeated exposure or single

exposure.

It is noted that the majority of 6.9 classifications were

based on repeated exposure. The default position

was therefore to assign STOT-repeated exposure

(either Category 1 or 2 as relevant). If existing data

were available to indicate a STOT single exposure

was relevant, this classification was also assigned.

Aquatic ecotoxicity (sub-class 9.1) Supporting information relating to acute and chronic

toxicity data, bioaccumulation and degradability was

used to convert subclass 9.1 classifications into GHS

classifications for acute and chronic aquatic

ecotoxicity.

Terrestrial ecotoxicity (sub-classes 9.2, 9.3 and 9.4) Substances that meet the definition of “agrichemical”

in the new Hazard Classification Notice that are

currently classified in subclasses 9.2, 9.3, and 9.4

classifications were assigned the following terrestrial

ecotoxicity classifications as relevant:

hazardous to soil organisms

hazardous to terrestrial vertebrates

hazardous to terrestrial invertebrates.


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90. GHS 7 classifications were assigned to all relevant substances using an automated process that

applied a series of rules based on the substance’s existing HSNO classifications, the correlation table,

classification criteria from both classification systems, and where necessary took into account the

relevant available information in the EPA approvals database for each substance.

91. The outputs from the automated process were reviewed by a subject matter expert focusing on

classifications that were not 1:1. These were then further reviewed by a member of the EPA GHS

Project Team.

92. Importantly, no new data or information was sought or assessed in determining the GHS 7

classifications10. Any changes to the hazard classification of a substance beyond those necessary to

implement the GHS 7 classification system are outside the scope of the legal authority to reissue

approvals under Schedule 7 of the HSNO Act. Any such changes would require a formal

reassessment under the HSNO Act.

List of proposed GHS classifications

93. Proposed GHS 7 classifications have been assigned to all individual approvals approved or

reassessed as at 1 January 2020:

GHS 7 classifications assigned to approvals that will be reissued or reassessed will

become the legal classifications for those substances

GHS 7 classifications assigned to approvals that will be revoked, and subsequently

managed under a group standard, are provided for information only and are not mandatory.

94. The proposed GHS 7 classifications for all individual approvals (excluding containment and

transhipment) are provided in the Classifications and Fates spreadsheet. This spreadsheet is available

in Appendix 6 and includes the following information:

HSNO approval number

approval name of the substance

current HSNO classification

proposed GHS 7 classification for the substance.

10 Other than for desensitised explosives and flammable gases.


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Question 1

Do you have any comments regarding any proposed GHS 7 classification assigned to any

individual hazardous substance approval?

Please note that we are only seeking comments on the accuracy of the mapping of existing HSNO

classifications to GHS 7 classifications. Evaluation of new data that may change the existing

HSNO hazard classification of a substance is outside the scope of the legal authority to reissue

approvals under Schedule 7 of the HSNO Act. This would require a formal reassessment under

the HSNO Act.

If you have any comments on any proposed GHS 7 classification, please provide the name and

approval number of the relevant substance(s) and describe your comments in detail.


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Proposal 2 – Proposed “fate” for individual approvals

Proposal 2

To propose “fates” (retain or revoke the approval) for all individual hazardous substances

approved or reassessed before 1 January 2020.

Note for those individual approvals we plan to revoke, we have included the name and approval

number of the relevant group standard(s) under which the approval can be managed.


95. Many individual hazardous substance approvals are effectively redundant as the substances are able

to be managed under one or more group standards. We are therefore proposing to revoke these

approvals.

96. The remaining individual approvals will be retained and either reissued using Schedule 7 or updated

using section 63C of the HSNO Act. The existing HSNO approval numbers will also be retained.

97. As at 1 January 2020, a total of 9,073 individual approvals have been issued including reassessments.

Of these:

3,445 individual approvals are proposed to be retained, of which:

o 3,312 were approved or reassessed before 1 December 2017 and will be reissued

o 133 were approved or reassessed after 1 December 2017 and will be updated under

section 63C11

5,628 individual approvals are proposed to be revoked. As noted earlier, indicative GHS

classifications have also been proposed for these approvals.

11 Section 63C of the HSNO Act provides the legal mechanism to assign GHS 7 classifications to these approvals

using a specific form of modified reassessment. The EPA may reassess a hazardous substance approval under

section 63C without publicly notifying the reassessment but as required by section 63C(5) must—

(a) do everything reasonably practicable to consult with all persons who may be affected by the

reassessment; and

(b) give those persons a reasonable opportunity to make submissions and comments on the reassessment;

and

(c) consider all submissions and comments received.


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Criteria for determining the fate of individual approvals

98. For each individual substance approval, we have proposed one of three fates:

revoke the approval (refer below for criteria used to make this determination)

reissue individual approvals issued before 1 December 2017 where the substance is not

able to be managed under an existing group standard(s), or it was considered appropriate

to retain the individual approval for reasons such as discussed in paragraph 104. As

discussed in Section 5, the reissued approvals will also have their controls updated, as well

as applying the GHS 7 classification system

update any individual approval issued after 1 December 2017 to apply the GHS 7

classification system. This update will be achieved by a modified reassessment under

section 63C.

Substance approvals proposed to revoke

99. The overarching consideration before proposing to revoke an individual substance approval was

whether the substance could be managed under one or more existing group standards. However, we

are proposing to retain some substances that meet this criterion due to consideration of other factors.

These are discussed in paragraph 104.

100. Examples of individual approvals proposed for revocation include:

substances that fit the scope (both in terms of hazard and use) of one or more existing

group standards

class 4 or class 5 substances with hazard classifications that fit the scope of one of the

class 4 or class 5 group standards

certain dangerous goods of low regulatory concern that were transferred in the Hazardous

Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice No 35,

2004

many pesticide and veterinary medicine active ingredients that fit the scope of the Active

Ingredients for the Manufacture of Agricultural Compounds Group Standard.

101. Of note is that some individual approvals proposed for revocation have control variations or additions

that will cease to exist when the individual approval is revoked. Currently, where a substance can be

managed under either an individual approval or a group standard, people can comply with either.

However, we are seeking feedback on whether there are any specific individual approvals proposed for

revocation that should be retained due to unique controls on that approval (refer to Question 2 in the

green box below).

102. Additionally, with the decision to not adopt certain GHS building blocks, some substances will no

longer be hazardous under HSNO. Such approvals are not able to be revoked under section 67B as

part of the reissue process. We will update the status of these approvals at a later date.


34

Substance approvals proposed to retain

103. We propose to retain (either reissue or update as relevant) individual approvals that do not fit the

scope of any of the current group standards. These comprise:

substances with high hazard classifications. There are no group standards that

accommodate the following hazard classifications: all class 1 classifications, 3.1A, all 3.2

classifications, all 4.1.2 classifications, all 4.1.3 classifications, 4.2A, 4.3A, 5.1.1A, 5.2A,

6.1A (with the exception of the group standards for agricultural compound and

pharmaceutical active ingredients), and 8.2A

some class 4 or class 5 substances with certain combinations of other high hazard

classifications

pesticide formulations

veterinary medicine formulations that have dispersive uses or otherwise do not fit the

Veterinary Medicine group standards (for example, feed additives)

active ingredients used in the manufacture of agricultural compounds that do not meet the

scope of the Active Ingredients for Use in the Manufacture of Agricultural Compounds

Group Standard

vertebrate toxic agents

fumigants.

104. There are some substances that we consider are best regulated by retaining their individual substance

approval, even though they could potentially be managed under a group standard. In these cases,

people will retain the option of whether to comply with the approval or the group standard (noting that

the classification assigned to the approval will be the mandatory classification) as provided for in

section 96E of the HSNO Act. These include:

most dangerous goods and scheduled toxic substances that were transferred in the

Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer

Notice No 35, 2004.

certain substances of significant regulatory interest, for example being listed on the EU

REACH12 list of “substances of very high concern”, substances that have specific transport

requirements, common high volume chemicals, and substances that are specifically

mentioned by name in the HSW Regulations.

12 Registration, Evaluation, Authorisation and Restriction of Chemicals. A European Union regulation adopted on

18 December 2006 (Regulation (EC) No 1907/2006)


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List of proposed fates

105. Proposed “fates” have been identified for all individual approvals in force as at 1 January 2020. These

are outlined in the Classifications and Fates spreadsheet available in Appendix 6. The spreadsheet

includes the following information:

HSNO approval number

approval name of the substance

proposal for whether the approval is to be revoked or retained (reissued or reassessed).

106. Where an approval is proposed to be revoked, we have provided the name and approval number of a

group standard that we consider the substance is covered by. However, we acknowledge that other

group standards could also be applicable. Importers or manufacturers are free to self-assign the

substance to any other group standard they consider is appropriate.

107. In such cases, the importer or manufacturer must, in accordance with the requirement in all group

standards, keep a record of the information they used to self-assign the substance. The record must

contain enough information to allow for independent verification that the substance meets the scope of

that group standard.

108. If an importer or manufacturer agrees with our assessment that a substances fits within the scope of

the group standard identified in the Classifications and Fates spreadsheet, this spreadsheet can serve

as the record of self-assignment. However, an importer or manufacturer must keep a record of the

relevant section(s) of this spreadsheet as evidence that the group standard requirement has been

met.

Question 2

Do you have any comments regarding our proposal to revoke any specific individual approval?

For example:

Do you consider that an individual approval proposed for revocation should be retained due to

its unique controls, e.g. a specific use restriction control, or an exemption from certain default

controls?

Do you have concerns that the substance does not fit in the group standard identified in the

Classifications and Fates spreadsheet and cannot fit in any other group standard?

If so, please provide the name and approval number of the relevant substance(s) and describe

your comments in detail.

Question 3

Do you have any comments regarding our proposal to retain any specific individual approval?

If so, please provide the name and approval number of the relevant substance(s) and describe

your comments in detail.


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Proposal 3 – Proposed changes to group standards

Proposal 3

To update the 208 group standards to apply GHS 7 classifications.


109. In 2017, the EPA reissued the 208 group standards to bring their controls into line with the new health

and safety regime that took effect on 1 December 2017. This work entailed:

removing the old HSNO workplace controls that were transferred to the HSW (Hazardous

Substances) Regulations

requiring compliance with the new EPA notices rather than the old HSNO Regulations

(noting that a four-year transitional period was provided for the Labelling Notice, Safety

Data Sheets Notice and Packaging Notice).

110. However, the reissued group standards still refer to the existing HSNO classification system and

therefore need to be updated to take account of adopting GHS 7.

Discussion

Consequential changes as a result of implementing GHS 7

111. The key changes we are proposing to make to the group standards as a result of implementing GHS 7

are to:

update each group standard to refer to GHS 7 classifications rather than HSNO

classifications

change the name of selected group standards, notably:

o The names of group standards that currently have a HSNO classification in their

name (e. g Toxic 6.1, Toxic 6.7) have been changed to use the GHS hazard class (e.

g acutely toxic, carcinogenic)

o The order of hazards in the names of some group standards that allow multiple

primary hazards has been changed to reflect the order that hazards are listed in the

GHS book

o The names of “Gas under pressure mixtures” group standards have been changed to

“Gases under pressure mixtures”

o The word “non-flammable” has been inserted into the name of non-flammable aerosol

group standards.

make minor changes to some definitions for clarity and consistency

add aerosol Category 3 as a mandatory primary hazard to non-flammable aerosol group

standards


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amend all the “Gases Under Pressure Mixtures” group standards to clarify that these group

standards apply to “gases under pressure” as defined in the Act.

add the classifications “hazardous to soil organisms”, “hazardous to terrestrial vertebrates”,

and “hazardous to terrestrial invertebrates” to the list of permitted subsidiary hazards in

selected group standards. This is to give effect to the proposal that these classifications will

be applied only to agrichemicals, and active ingredients used in the manufacture of

pesticides and veterinary medicines. The selected group standards are:

o Active Ingredients for Use in the Manufacture of Agricultural Compounds Group

Standard

o Veterinary Medicines Group Standards

o Agricultural Compounds Special Circumstances Group Standard

o Animal Nutritional and Animal Care Products Group Standard

o Fertilisers Group Standards

o Straight-chained Lepidopteran Sex Pheromone Group Standard13

o Additives, Process Chemicals and Raw Materials Group Standards14

add the classification “designed for biocidal action” to the list of permitted subsidiary

hazards in selected group standards. This is to give effect to the proposal that this

classification will be applied only to agrichemicals, and active ingredients used in the

manufacture of pesticides and veterinary medicines. The selected group standards are:

o Active Ingredients for Use in the Manufacture of Agricultural Compounds Group

Standard

o Veterinary Medicines Group Standards

o Agricultural Compounds Special Circumstances Group Standard

o Straight-chained Lepidopteran Sex Pheromone Group Standard 15.

Other changes

112. In addition to the consequential changes outlined above, we are also proposing to amend a small

number of group standards to either correct existing errors or make them more workable. Details of

the relevant issue, and proposed amendment to remedy the problem in each case, are outlined in

Table 5 below.

13 The hazard classifications permitted in this group standard are listed by exclusion rather than inclusion.

The three terrestrial ecotoxicity classifications will not be listed as excluded hazards.

14 These classifications will only be applied to agrichemicals and active ingredients used in the manufacture of

agrichemicals.

15 The hazard classifications permitted in this group standard are listed by exclusion rather than inclusion.

“Designed for biocidal action” will not be listed as an excluded hazard.


38

Table 5. Other proposed changes to selected group standards

Current issue Proposed amendment

There are currently no group standards that allow for substances

that are corrosive to metal (8.1A), but not corrosive to the skin.

This is because the classification 8.1A is listed as a subsidiary

hazard in corrosive group standards (which must be 8.2B or

8.2C skin corrosives) and is not a permitted hazard in any other

group standard.

To add metallic corrosive Category 1 as an

optional primary hazard in corrosive group

standards. Note that there are only a small

number of substances affected by making

this change.

When the original group standards were issued in July 2006, all

“Compressed Gas Mixtures” group standards that permitted 6.1B

or 6.1C substances in them included a clause restricting sale or

supply to workplaces only.

When the group standards were reissued on 1 December 2017,

this clause was inadvertently omitted from “Gas Under Pressure

Mixtures (Toxic [6.1], Flammable, Corrosive) Group Standard

2017 - HSR002539”.

To add the sales restriction clause back into

group standard HSR002539.

The specific wording of the clause is “A

substance covered by this Group Standard

must only be sold or supplied for use in a

place of work where members of the public

do not have access to the substance”.

There is a cross-referencing error in the Dental Products

(Subsidiary Hazard) Group Standard 2017 – HSR002558.

Specifically, there is a cross-referencing error in clause 1 (3) in

Schedule 1, which relates to labelling requirements for oral

hygiene products. The current clause is:

(3) in addition to the requirements in subclause (2) for oral

hygiene products containing or releasing hydrogen

peroxide, there must be on the label the precautionary

statement: “If irritation occurs, discontinue use”.

The cross-reference to subclause (2) should be subclause (1).

To correct the cross-referencing error in

clause 1 (3) in Schedule 1 in group standard

HSR002558.


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Current issue Proposed amendment

The three veterinary medicine group standards use both the

terms “active ingredient” and “veterinary medicine active

ingredient” in various clauses. The new Hazard Classification

Notice also uses the term “active ingredient”, and it is defined

differently from the definition in the veterinary medicine group

standards.

In order to reduce confusion, we are proposing to amend the

three veterinary medicine group standards to use the term

“veterinary medicine active ingredient” exclusively, including in

the definition.

The three affected group standards are:

Veterinary Medicines (Limited Pack Size, Finished Dose)

Group Standard 2017 – HSR100757

Veterinary Medicines (Non-dispersive Closed System

Application) Group Standard 2017 – HSR100758

Veterinary Medicines (Non-dispersive Open System

Application) Group Standard 2020 – HSR100759

To amend all relevant clauses in the three

veterinary medicine group standards to use

the term “veterinary medicine active

ingredient” rather than “active ingredient”.

In addition, clause 8 of group standards

HSR100758 and HSR100759 is reworded to

remove the double negative. The proposed

new wording of the clause is:

This Group Standard excludes any veterinary

medicine that contains a veterinary medicine

active ingredient that—

does not have an approval under

section 28A or section 29 of the Act: or

is not an ingredient in a veterinary

medicine that has an approval under

section 28A or section 29 of the Act.

Proposed Group standards

113. The proposed group standards are available in Appendix 5. For each proposed group standard two

documents are provided, a “clean” version and a second version in tracked changes to indicate all

modifications, additions and deletions.


40

Question 4

Do you have any comments regarding the list of proposed GHS 7 classifications included in the

scope section of any group standard?

If so, please describe your comments in detail.

Question 5

Do you have any comments regarding any of the proposed name changes of any group standard?


Question 6

Do you have any comments regarding any of the proposed changes to the definitions in any group

standard?


Question 7

Do you have any comments regarding the proposal to add aerosol Category 3 as a mandatory

primary hazard to the “non-flammable aerosol” group standards?


Question 8

Do you have any comments regarding the proposed amendment to the “Gases Under Pressure

Mixtures” group standards to clarify that these group standards apply to “gases under pressure” as

defined in the Act?


Question 9

Do you have any comments regarding the proposal to add the classifications “hazardous to soil

organisms”, “hazardous to terrestrial vertebrates” and “hazardous to terrestrial invertebrates” to the

list of permitted subsidiary hazards in selected group standards?


Question 10

Do you have any comments regarding the proposal to add the classification “designed for biocidal

action” to the list of permitted subsidiary hazards in selected group standards?



41

Question 11

Do you have any comments regarding the proposal to add metallic corrosive Category 1 as an

optional primary hazard in corrosive group standards?


Question 12

Do you have any comments regarding the proposal to add the sales restriction clause back into

the Gas Under Pressure Mixtures (Toxic [6.1], Flammable, Corrosive) Group Standard 2017

(HSR002539)?


Question 13

Do you have any comments regarding the proposal to correct the cross-referencing error in

clause 1 (3) in Schedule 1 of the Dental Products (Subsidiary Hazard) Group Standard 2017

(HSR002558)?


Question 14

Do you have any comments regarding the proposed changes to the three veterinary medicine

group standards regarding the more consistent use of the term “veterinary medicine active

ingredient”, and the proposed changes to the wording of clause 8 in HSR100758 and

HSR100759?


Question 15

Do you have any other comments regarding any of the proposed changes to any of the group

standards?



42

Proposal 4 – Control mapping (individual approvals approved or reassessed before 1 December 2017)

Proposal 4

To update the controls placed on substances approved or reassessed before 1 December 2017

to take account of the health and safety reforms implemented on 1 December 2017.


114. New Zealand's health and safety system was significantly reformed in 2015 by the enactment of the

Health and Safety at Work Act 2015. On 1 December 2017, the HSW (Hazardous Substances)

Regulations came into force, with many workplace controls being transferred out of HSNO into these

new regulations. At the same time, many existing HSNO regulations were revoked and replaced by a

suite of EPA notices.

115. As a result of these regulatory changes, the controls listed in approval documents for substances

approved before 1 December 2017 are no longer correct. As noted earlier in this document, we are

proposing to revoke 5,623 of these individual approvals as their approval is essentially redundant16.

The remaining 3,312 will be reissued to:

remove any HSNO workplace controls that were transferred to the HSW (Hazardous


remove any HSNO controls that require compliance with the now revoked HSNO


retain any HSNO section 77 or 77A control variations as relevant.

Discussion

116. We have created a controls mapping spreadsheet that shows the relationship between the original set

of controls that were assigned to approvals issued before 1 December 2017 and the new set that will

apply once the 3,312 approvals have been reissued.

117. This spreadsheet contains four tabs:

The first tab lists all the (default) HSNO controls that existed before 1 December 2017 and

which of the following legislative instruments those controls were transferred to:

o the HSW (Hazardous Substances) Regulations 2017

o a Safe Work Instrument made under the HSW Act

o an EPA notice.

16 A further five individual approvals that were issued after 1 December 2017 will also be revoked.


43

The second tab lists the control variations or additions on substances approved before

1 December 2017 that have been transferred to one of the legislative instruments listed

below. These additional / varied controls will no longer need to be identified as unique

controls in the substance approval. However, all control variations or additions not

transferred to one of these legislative instruments will be retained on the individual

approval.

o the HSW (Hazardous Substances) Regulations 2017

o a Safe Work Instrument made under the HSW Act

o an EPA notice.

The third tab lists new HSNO requirements in EPA notices that did not exist under the old

HSNO Regulations. Once reissued, substances will need to comply with these new

provisions, along with all the other notice provisions, subject to any transitional provisions.

The fourth tab lists new requirements in the HSW (Hazardous Substances) Regulations

2017 that did not exist under the old HSNO Regulations. All substances, including those

that had not been reissued, were required to comply with these regulations from

1 December 2017, with the exception of a few regulations that came into force in 2018 or

2019.

118. Note that the controls mapping spreadsheet is for information only. A legal approval document will be

issued for each reissued approval that contains a full set of HSNO controls that apply to that

substance. Reference will also be made to relevant HSW requirements.

119. The controls mapping spreadsheet is available in Appendix 7.

Question 16

Do you have any comments regarding the controls mapping spreadsheet?



44

Proposal 5 – Remove requirement for signage on basis of terrestrial ecotoxicity hazards

Proposal 5

To amend the Hazardous Property Controls Notice to no longer require signage for

agrichemicals on the basis of their terrestrial ecotoxicity hazards.


120. Signage is currently required for all class 9 substances (i.e. substances that are hazardous to the

aquatic and/or terrestrial environment) if they are stored above certain threshold quantities as listed in

Schedule 8 of the Hazardous Property Controls Notice. Different threshold quantities are set for

various classifications, depending on their degree of hazard.

121. As noted in Table 2 of this document, the updated classification system will provide for the following

four sub-categories of substances that are hazardous to the terrestrial environment.

hazardous to soil organisms (currently 9.2A-D)

hazardous to terrestrial vertebrates (currently 9.3A-C)

hazardous to terrestrial invertebrates (currently 9.4A-C)

designed for biocidal action (currently captured under 9.1D)

122. Due to the way we have “rolled up” these classifications, we are unable to replicate the current

threshold quantities that trigger the signage requirement for class 9.2A-D, 9.3A-C and 9.4A-C hazards.

Discussion

123. We therefore need to reconsider the approach for signage requirements for substances with terrestrial

ecotoxicity hazards. Of note is that after April 2021, these classifications will only be applied to

agrichemicals and pesticide and veterinary medicine active ingredients.

124. After considering different options, we propose to no longer require signage for substances on the

basis of their terrestrial ecotoxicity hazards. Our reasons for this are:

Deleting this requirement will only affect agrichemicals with terrestrial ecotoxicity hazards

that do not have any other notable hazards. If the substance is also hazardous to the

aquatic environment, acutely toxic, corrosive, or has any physical hazards at all, it will still

require signage. Of the thousands of agrichemicals we have approved, only 59 are affected

by this proposal.

This type of signage is required for sites storing large quantities of substances (the current

range of threshold quantities that triggers the signage control for terrestrial ecotoxicity

hazards is 100 – 10,000L) – it is not related to situations involving use of the substances.

These signs are primarily for emergency management purposes, the main purpose of

which is to warn emergency responders of the hazards presented by the substances stored


45

on the site. The relevance of information on terrestrial ecotoxicity hazards in such

situations is uncertain. For the other hazards, the basis for these signs is often the

HAZCHEM emergency response system that is contained in emergency response

handbooks. This system does not include hazards to the terrestrial environment.

Substances with terrestrial ecotoxicity hazards do not trigger the requirement for

emergency response plans or secondary containment, both of which are also emergency

management controls. It is somewhat inconsistent for signage to be required in the

absence these other controls.

Removing this control as a default requirement will not preclude the ability of the EPA to

add it to any substance approval, under section 77 of the HSNO Act, if deemed warranted

following the risk assessment of the substance.

Question 17

Do you agree with our proposal to amend the Hazardous Property Controls Notice to no longer

require signage for agrichemicals on the basis of their terrestrial ecotoxicity hazards?

Please provide a detailed rationale in your response.


46

7. Responding to this document

Proposals and submission form

125. The EPA is seeking your views on the proposals presented in this consultation document. This

document includes questions to help you provide feedback. Your contribution to this consultation is

important as it will enable the EPA to make more informed decisions on the proposals in this

consultation document.

126. This consultation document will be available for public comment until 5pm, 4 August 2020.

127. You can make a submission online using the form available in the Public Consultations: Open for

submission area of the EPA website https://www.epa.govt.nz/public-consultations/open-

consultations/GHS-Implementation-Consultation-2/. The submission form includes the questions

asked throughout this consultation document.

128. If you are unable to enter your submission online, please contact [email protected].

Hearing

129. If you have made a submission in respect of an individual approval that was granted or reassessed

after 1 December 2017, or on any proposed updates to a group standard, you are able to indicate in

your submission if you wish to be heard at a hearing. A hearing will be held if the DMC considers it is

necessary or if a person had asked to be heard.

Posting and release of information

130. The EPA will post all, or parts of, any written submission on its website at www.epa.govt.nz. By

making a submission, it is implied that you consent to such publication, unless you clearly specify

otherwise in your submission.



mailto:[email protected]

http://www.epa.govt.nz/


47

Appendix 1. Glossary of Terms

Active ingredient means the ingredient or ingredients in a formulated product that is/are primarily

responsible for the biological or other effects that make the product an agrichemical, and is distinct from

other ingredients of the formulated product such as adjuvants or additives

Agrichemical means a substance used or intended for use in the direct management of plants and

animals, or to be applied to the land, place, or water on or in which the plants and animals are

managed, for the purposes of —

(a) managing or eradicating pests, including vertebrate pests; or

(b) maintaining, promoting, or regulating plant or animal health, productivity, performance or

reproduction; or

(c) enhancing the effectiveness of an agrichemical used for the treatment of plants or animals;

or

(d) mitigating environmental, sustainability, or climate change impacts; and

for the avoidance of doubt:

(a) includes any veterinary medicine, pesticide adjuvant, fertiliser, plant growth regulator,

fumigant or domestic pesticide, and

(b) excludes any timber treatment chemical, antisapstain chemical and antifouling paint.

Classifications and Fates Spreadsheet is a spreadsheet that lists the proposed GHS 7 classifications

and proposed fates (whether the approval will be revoked or retained) of the 9,073 individual approvals

(available in Appendix 6)

DMC means the HSNO decision-making committee

GHS means the Globally Harmonised System of Classification and Labelling of Chemicals, Seventh

revised edition, 2017, published by the United Nations

HSNO Act means the Hazardous Substances and New Organisms Act 1996

HSW Act means the Health and Safety at Work Act 2015

HSW (Hazardous Substances) Regulations means the Health and Safety at Work (Hazardous

Substances) Regulations 2017

REACH - Registration, Evaluation, Authorisation and Restriction of Chemicals. A European Union

regulation adopted on 18 December 2006 (Regulation (EC) No 1907/2006)


48

Appendices 2-7 can be found on our Public Consultations: Open for submission page of the EPA

website, under Implementing the Globally Harmonized System of Classification and Labelling of

Chemicals (GHS) – Consultation 2, https://www.epa.govt.nz/public-consultations/open-

consultations/GHS-Implementation-Consultation-2/

Appendix 2. October 2019 consultation document

Appendix 3. Submissions analysis report from October 2019 consultation

Appendix 4. Exposure drafts of new and amended notices

Appendix 5. Proposed group standards

Appendix 6. Proposed classifications and fates of approved substances

Appendix 7. Proposed controls mapping spreadsheet



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Implementation of GHS 7 - EPA · 2020-06-07 · Implementation of GHS 7 – Implications for hazardous substance approvals and group standards | June 2020 7 1. Executive Summary 1