under section 62 of the Hazardous Substances and New Organisms Act 1996

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Send by post to: Environmental Protection Authority, Private Bag 63002, Wellington 6140 OR email to: HSApplications@epa.govt.nz

Payment must accompany application; see our fees and charges schedule for details.

Application Form: HS8 Application for whether there are Grounds for a Reassessment of a

Hazardous Substance

under section 62 of the Hazardous Substances and New Organisms Act 1996

REASSESSMENT

Applicant:

International Copper Association Southeast Asia Limited (ICA SEA)

Date:

2^nd October 2018

APPLICANT CHECKLIST

Mandatory sections filled out Appendices enclosed

Fees enclosed

Signed and dated

OFFICE USE ONLY

Application code Date received

EPA contact Fees paid $ Application version no.

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Important

1. Before you fill in this application form, please talk to the EPA. We can help you scope and prepare your request.

2. We need all relevant information early on in the process. Quality information up front will speed up the process.

3. Any extra material that does not fit in the form should be clearly labelled and cross-referenced. If there is commercially sensitive information, it should be collated in a separate document.

4. All applicants must sign the form at the end of Part A and enclose the correct application fee. Please check the EPA’s current pricing policy: http://www.epa.govt.nz/about-us/fees/Pages/Hazardous-Substances-fees- schedule.aspx. We are unable to process applications that do not contain the correct fee.

5. Copies of all our application forms are available on our website: http://www.epa.govt.nz.

6. If you have any suggestions for improvements to this form, please contact our operations staff at the address below.

7. You can get more information at any time by telephoning, writing to, or calling in at our Wellington office. One of our staff members will be able to help you.

Environmental Protection Authority Private Bag 63002

Wellington New Zealand

Telephone: 64 4 916 2426 Facsimile: 64 4 914 0433

Email: HSApplications@epa.govt.nz http://www.epa.govt.nz

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1. Applicant details

This should be the organisation or person formally responsible for this application, and be located within New Zealand.

Name:

Address:

Phone:

Fax:

Email:

Service Address (if different from above): Same as above

1.2. Contact’s details (if different from above).

Name:

Address:

Phone:

Fax:

Email:

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2. Hazardous substance details

2.1. Name of substance (identify the substance as fully as possible).

If more than one substance is involved – for example, the active ingredient and the products – they should all be listed.

Property

Substance Name CAS Number IUPAC Name Molecular Formula

1 Copper, powder 7440-50-8¹ Copper Cu

2 Copper sulphate

pentahydrate 7758-99-8 Copper (II) sulphate CuSO4; 5H2O

3 Copper (II) oxide 1317-38-0 Copper (II) oxide CuO

4 Copper (I) oxide 1317-39-1 Copper (I) oxide Cu2O

5 Copper (II) oxychloride 1332-65-6 Dicopper chloride

trihydroxide Cu2Cl(OH)3

2.2. If the substance has been assessed by the authority, list the reference number(s) of the existing approval (from the authority’s register).

If more than one substance is involved, for example, the active ingredient and the products, they should all be listed.

Substance Name CAS Number HSNO Approval Number

1 Copper, powder 7440-50-8 HSR002948

2 Copper sulphate pentahydrate 7758-99-8 HSR003126

3 Copper (II) oxide 1317-38-0 HSR002766

4 Copper (I) oxide 1317-39-1 HSR002871

5 Copper (II) oxychloride 1332-65-6 HSR003766

In addition to the above, substances containing copper powder, coper sulphate pentahydrate, copper (II) oxide, copper (I) oxide, and/or copper (II) oxychloride

2.3. If the substance is covered by Parts XI to XV, list any reference numbers of registrations, licenses etc under the Explosives Act, Pesticides Act, Toxic Substances Act, Dangerous Goods Act or Animal Remedies Act.

1 Copper metal (also referred to as massive or elemental copper), as well as granulated copper and copper flakes, coated with aliphatic acids are also associated with this CAS Number.

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3. Grounds for reassessment

3.1. Please indicate which category applies.

More than one may be relevant.

Has significant new information relating to the effects of the substance become available?



Yes (go to question 3.2)

Has another substance with similar or improved beneficial effects and reduced adverse effects become available?

Has information showing a significant change of use of the substance become available?

Has information showing a significant change in the quantity of the substance manufactured or imported become available?

Other?

3.2. Provide details of the significant new information relating to the effects of the substance. (Include the date and some of the information.)

Further information?



Yes No

The current New Zealand classifications for copper powder and the inorganic copper compounds listed above are notably different than the hazard data accepted by the Organization for Economic Co-operation and Development (OECD) would indicate. According to the OECD Cooperative Chemicals Assessment Programme, stakeholders could apply for a chemical assessment by submitting a Screening Information Dataset (SIDS) Initial Assessment Profile (SIAP) to the OECD Cooperative Chemicals Assessment Meeting (CoCAM). In May 2014, the International Copper Association (ICA), on behalf of the copper industry, submitted the SIAP of copper and inorganic copper compounds to the OECD Secretariat. After four months of discussion and modification in accordance with member

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countries’ comments, the revised SIAP, which indicates that copper in both the massive and power forms should not be classified for human health hazards, was approved at the OECD CoCAM 6.

The SIAP covers copper massive and powder, coated copper flakes and several inorganic copper compounds, as assessed under the industry’s European Union (EU) Voluntary Risk Assessment, approved by the EU Chemicals Agency (ECHA) and peer reviewers in 2008. While the SIAP does not provide definitive classifications, its conclusions regarding the copper-related human health and environmental hazards are, in fact, aligned with the classification decisions that have been made under the European Union’s Regulation of the Classification, Packaging, and Labelling (CLP) of Substances and Mixtures. Therefore, this compendium of recent scientific information (i.e., the SIAP) forms a sufficient basis for the EPA to consider initiation of the reassessment process for copper and inorganic copper compounds.

The SIAP (Appendix 1) and a comparison of the GHS classifications adopted by New Zealand against those indicated in the SIAP (Appendix 2) are for EPA’s review. A table that reflects the proposed classifications and the justification for changing those classifications is also included at the end of this application. If grounds for

reassessment are established, more detailed information will be provided regarding the recommended levels of classification.

We note that copper(I) oxide has also been included as one of many substances in EPA’s 2013 Classification Report for Antifouling Paints. We would like to ensure that our requested copper reassessment does not conflict with the 2013 Antifouling Paint update, so we welcome EPA’s guidance on how to ensure that the two

classifications for copper(I) oxide are harmonized.

Commercially sensitive information? Yes



No

3.3. Provide details of the information relating to the effects of the new substance (include the date and some of the information). The beneficial and adverse effects of the new substance should be compared with those of the substance.

Further information? Yes



No



No

3.4. Provide details of the significant change of use of the substance (include the former use and information on how this change has come about).



No



No

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3.5. Provide details of the significant change in the quantity of the substance manufactured or imported.



No



No

3.6. Provide details of other reasons requesting a reassessment.



No



No

3.7. Provide any other information relevant to the request for reassessment.



No



No

4. Declaration

2^nd October 2018

Signature of applicant or person Date authorised on behalf of applicant

Name:

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Schedule 1 Substances for reassessment

This schedule lists all the substances proposed for reassessment under this application. Current classifications and proposed classifications are given. The following table also includes the justification for the proposed changes. If grounds for reassessment are established, more detailed information will be provided regarding the recommended levels of classification.

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Substances affected

Approval numbers Current classification Proposed classification

Justification for change

Copper, powder CAS No. 7440-50-8

HSR002948 Human Health Hazards:

6.1B (acute toxic), 6.1B (oral and inhalation), 6.4A (eye irritation), 6.5B (skin sensitization), 6.6A (mutagenicity), 6.9B (target organs/system), 6.9B (oral and inhalation)

Environmental Hazards:

9.1A (ecotoxicity for aquatic environment),

9.1A (fish), 9.1A (crustacean), 9.1A (algal), 9.2D (soil),

9.3A (terrestrial vertebrates)

Human Health Hazards:

No classification

Environmental Hazards:

May pose a hazard for the aquatic environment depending on the release/bioaccessibility of copper ions and on the conditions of the receiving environment (pH, hardness, presence and type of organic matter, anions and competing cations)

By using the read-across approach via other forms of copper and

inorganic copper compounds, the new information supports that copper powder does not pose a hazard to human health (pages 3-15 of the SIAP). We, therefore, suggest removing the acute toxicity, eye irritation, skin sensitization, mutagenicity, and specific target organ toxicity classifications of copper powder.

The new information shows that solubility and

transformation/dissolution of various copper-bearing materials, plus the characteristics of the receiving environment, are the key elements for evaluating environmental hazards of inorganic substances. The SIAP concludes that these factors must be integrated in effects and risk

characterisation (pages 15-20 of the SIAP). We, therefore, propose to reclassify copper powder accordingly.

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Copper sulphate pentahydrate CAS No. 7758-99-8

HSR003126 Human Health Hazards:

6.1D (acute toxic), 6.1D (oral),

6.3A (skin irritation), 6.4A (eye irritation), 6.5B (skin sensitization), 6.9B (target organs/system), 6.9B (oral)

9.1A (fish), 9.1A (crustacean), 9.1A (algal),

9.3C (terrestrial vertebrates)

- Acute toxicity by oral route - Eye irritation

May present a hazard for the environment depending on the release/bioaccessibility of copper ions and on the conditions of the receiving environment (pH, hardness, presence and type of organic matter, anions and competing cations)

The new information does not support the classification of this substance as a skin irritant or sensitizer (pages 3-15 of the SIAP). The new information also demonstrates that there is no evidence to indicate that this substance presents hazards for repeat dose toxicity from oral exposure. We, therefore, suggest removing the skin irritation, skin sensitization, and specific target organ toxicity classifications of copper sulphate pentahydrate.

characterisation (pages 15-20 of the SIAP). We, therefore, propose to reclassify copper sulphate pentahydrate accordingly.

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affected classification Copper (II) oxide

CAS No. 1317-38-0

6.1D (acute toxic), 6.1D (oral), 6.4A (eye irritation), 6.9B (target organs/system), 6.9B (oral)

9.1A (fish), 9.1A (crustacean),

Human Health Hazards:

No classification

By using the read-across approach via other forms of copper and

inorganic copper compounds, the new information supports that copper (II) oxide does not pose a hazard to human health (pages 3-15 of the SIAP). We, therefore, suggest removing the acute toxicity, eye irritation, and specific target organ toxicity classifications of copper (II) oxide.

characterisation (pages 15-20 of the SIAP). We, therefore, propose to reclassify copper (II) oxide accordingly.

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Copper (I) oxide CAS No. 1317-39-1

6.1D (acute toxic), 6.1D (oral), 6.1D (inhalation), 6.4A (eye irritation),

6.9B (target organs/system), 6.9B (oral),

6.9B (inhalation)

9.1A (fish), 9.1A (crustacean), 9.1A (algal),

- Acute toxicity by oral route - Acute toxicity by inhalation route - Eye irritation

The new information demonstrates that there is no evidence that this substance presents hazards for repeat dose toxicity from oral and inhalation exposures (pages 3-15 of the SIAP). We, therefore, suggest removing the specific target organ toxicity classifications of copper (I) oxide.

characterisation (pages 15-20 of the SIAP). We, therefore, propose to reclassify copper (I) oxide accordingly.

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affected classification Copper (II) oxychloride

CAS No. 1332-65-6

6.1D (acute toxic), 6.1D (oral),

6.5B (skin sensitization), 6.9B (target organs/system), 6.9B (oral)

9.1A (fish), 9.1A (crustacean),

- Acute toxicity by oral route - Acute toxicity by inhalation route

Human Health Hazards

The new information does not support the classification of this substance as a skin sensitizer. The new information also demonstrates that there is no evidence that this substance presents hazards for repeat dose toxicity from oral exposures (pages 3-15 of the SIAP). We, therefore, suggest removing the skin sensitization and specific target organ toxicity classifications of copper (II) oxychloride.

characterisation (pages 15-20 of the SIAP). We, therefore, propose to reclassify copper (II) oxychloride accordingly.