hazardous substance approvals and group standards

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Implementation of GHS 7

Implications for

hazardous substance approvals and group standards

Consultation Document 2

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/ ).

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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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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/

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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.

Refer to section 6 and 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.

Refer to section 6 and 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.

Refer to section 6 and 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.

Refer to section 6 and 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:

 replace occurrences of existing HSNO classes/classifications with GHS 7 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

 replace occurrences of existing HSNO classes/classifications with GHS 7 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.

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 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 Substances) Regulations on 1 December 2017

o remove any HSNO controls that require compliance with the now revoked HSNO regulations and instead require compliance with the new EPA notices

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.

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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.

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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

hazardous substance approvals and group standards

Implementation of GHS 7

Implications for