SECTION 67A AMENDMENT OF APP203097
30 July 2017
1. Summary
Substances BioShield®75
ProShield®5000D
Amendment code APP203328
Type Minor or technical amendments to approvals under Section 67A of the Hazardous Substances and New Organisms Act 1996 (“the Act”) Purpose To make a minor or technical amendment to approvals HSR101212
and HSR101213: “To import BioShield®75 and ProShield®5000D for use as bound antimicrobial surface protectants”
Date request received 5 July 2017
Consideration date 27-30 July 2017
Considered by The Chief Executive1 of the Environmental Protection Authority (“the EPA”):
Decision Amendment is minor in effect
Approvals are amended Original application code APP203097
Approval codes HSR101212
HSR101213
1 The Chief Executive of the EPA has made the decision on this application under delegated authority in accordance with section 19 of the Act.
2. Background
2.1. Approvals for BioShield®75 (HSR101212) and ProShield®5000D (HSR101213) were granted on 12 February 2017. The purpose of the application (APP203097) was “to import
BioShield®75 and ProShield®5000D for use as bound antimicrobial surface protectants.”
2.2. These approvals have previously been amended to change the purpose statement from “To import BioShield®75 and ProShield®5000D for use as antimicrobial surface cleaners” to “To import BioShield®75 and ProShield®5000D for use as bound antimicrobial surface
protectants”.
2.3. On 5 July 2017, the EPA received a request from IndusCo Ltd to amend these approvals, in particular the purpose statement and decision, in order to include manufacture.
3. Eligibility
3.1. The EPA may amend any approval it has granted if it considers that the alteration is minor in effect or corrects a minor or technical error.
3.2. The change in wording of the purpose statement and decision to include manufacture fulfils the criterion of being minor in effect because there is no change in risk.
4. Amendment
4.1. The decision document for application APP203097, approval numbers HSR101212 and HSR101213 is modified. The purpose statement and paragraph 6.3 of the decision are modified to include the words “and manufacture”.
The purpose statement now states:
To import and manufacture BioShield®75 and ProShield®5000D for use as bound antimicrobial surface protectants
Paragraph 6.3 of the decision now states:
I have determined that the benefits of this substance outweigh any adverse effects.
Therefore, the import and manufacture of BioShield®75 and ProShield®5000D is approved with controls as listed in Appendix A and B.
5. Consideration
5.1. Pursuant to section 67A of the Act, the proposal to amend approvals HSR101212 and HSR101213 has been considered.
5.2. The amendment is considered to be minor in effect; therefore, the approvals have been amended.
Dr Allan L Freeth Date: 30 July 2017 Chief Executive, EPA
DECISION
Amended under section 67A on 22 March 2017 12 February 2017
Summary
Substance Name BioShield®75 and ProShield®5000D
Application code APP203097
Application type To import or manufacture for release any hazardous substance under Section 28 of the Hazardous Substances and New Organisms Act 1996 (“the Act”)
Application sub-type Section 28A(2)(a) – rapid similar – having a similar composition and similar hazardous properties to a substance that has been approved under the Act
Applicant IndusCo Ltd
Purpose of the application To import BioShield®75 and ProShield®5000D for use as bound antimicrobial surface protectants
Date application received 27 January 2017
Consideration date 10-12 February 2017
Considered by The Chief Executive1 of the Environmental Protection Authority (“the EPA”)
Decision Approved with controls
Approval code HSR101212 BioShield®75
HSR101213 ProShield®5000D
Hazard classifications BioShield®75 6.3B, 9.1C
ProShield®5000D 8.2C, 8.3A, 9.1B
1 The Chief Executive of the EPA has made the decision on this application under delegated authority in accordance with section 19 of the Act.
1. Background
1.1. BioShield®75 and ProShield®5000D are cleaning products containing 3-(trimethoxysilyl)-
propyldimethyloctadecyl ammonium at concentrations of 0.75% and 5.0% respectively. They are intended to be imported and used as both home use and commercial cleaning products.
2. Process and consultation
Application receipt
2.1. The application was formally received on 27 January 2017 under section 28 of the Act.
Information available for consideration
2.2. The information available for the consideration comprised:
the application form
confidential appendices to the application
the EPA staff advice memorandum.
2.3. I consider that I have sufficient information to assess the application.
Notification to government departments
2.4 In line with section 53(4) of the Act, WorkSafe New Zealand and the Ministry of Health were notified of the application on 27 January 2017. No comments were received.
Legislative criteria for the application
2.5 This application meets the criteria for rapid assessment under section 28A(2)(a) of the Act, as I consider that substances having similar compositions and similar hazardous properties have been approved.
2.6. In considering this application, I took into account the relevant sections of the Act, the Hazardous Substances Regulations and the Hazardous Substances and New Organisms (Methodology) Order 1998.
3. Hazardous properties, prescribed controls and exposure limits
Hazardous properties
3.1 The hazard classifications of BioShield®75 and ProShield®5000D were determined based on the information provided by the applicant and other available information. The hazard classifications are shown in Table 1.
Table 1: Hazard classifications of BioShield®75 and ProShield®5000D
Hazard BioShield®75 ProShield® 5000D
Skin irritancy/corrosivity 6.3B 8.2C
Eye corrosivity - 8.3A
Aquatic ecotoxicity 9.1C 9.1B
Prescribed controls
3.2 The hazard classifications of BioShield®75 and ProShield®5000D determine a set of prescribed controls specified by the Hazardous Substances Regulations under the Act.
3.3 The prescribed controls set the baseline for how the substance must be managed and include specifications on how the substance is to be packaged, labelled, stored, disposed of, transported, handled and used. The prescribed controls also set information requirements (e.g. safety data sheets), signage and emergency management. These controls form the basis of the controls specified in Appendices A and B.
Exposure limits
3.4 Several prescribed controls allow the EPA to set human health and environmental exposure values.
3.5 Control T1 allows the EPA to set ADE (Acceptable Daily Exposure), PDE (Potential Daily Exposure) and TEL (Tolerable Exposure Limit) values. No ADE value has been set for the active ingredient under control T1 previously. No ADE value has been set at this time because I consider that exposure to this substance is not likely to result in an appreciable toxic effect to people. Therefore, the criteria for setting an ADE value under regulation 11(1)(c) of the Hazardous Substances (Classes 6, 8 and 9) Regulations 2001 was not met. As no ADE value has been set, then no PDE or TEL value is required to be set.
3.6 Control T2 allows Workplace Exposure Standard (WES) values to be set for any component of a substance to limit the exposure of people to toxic substances in places of work. I have adopted and applied the WES values listed in the WorkSafe New Zealand Standard Workplace Exposure Standards and Biological Exposure Indices 8th Edition2 for all components of this substance in accordance with regulation 30(1)(a) of the Hazardous Substances (Classes 6,8 and 9) Regulations 2001, where applicable.
3.7 Control E1 allows the EPA to set Environmental Exposure Limit (EEL) values. As no EEL values are set at this time or have been previously set for this active ingredient, the default EEL of 0.1 µg/L of 3- (trimethoxysilyl)-propyldimethyloctadecyl ammonium chloride in water applies to this substance. The EEL only applies to 3-(trimethoxysilyl)-propyldimethyloctadecyl ammonium chloride because no other components in BioShield®75 and ProShield®5000D contribute to the ecotoxic classification.
2 Or any subsequent version of this Standard approved or endorsed by the EPA.
4. Risk and benefit assessment
Assessment of risks to human health and the environment
4.1 The risk assessment takes into account the hazardous properties, prescribed controls, the additional controls applied to the substances and other legislation such as the Land Transport Rule 45001, Civil Aviation Act 1990 and Maritime Transport Act 1994.
4.2 The risk and benefit assessment:
considers the risks posed by BioShield®75 and ProShield®5000D
determines whether the risks are outweighed by the benefits
determines whether any variations or additions to the prescribed controls are required to manage the risks of this substance, and identifies controls that may not be applicable or necessary that can, therefore, be deleted.4.3 I consider that the prescribed controls and other legislative requirements, including those under the Land Transport Rule 45001, Civil Aviation Act 1990, Maritime Transport Act 1994 and Health and Safety at Work Act 2015, will reduce the risks of these substances to human health and the environment to negligible during the importation, transportation, storage and disposal of these substances.
4.4 The risks associated with BioShield®75 and ProShield®5000D during use arise from its hazardous properties and its proposed use pattern. I consider that with the prescribed controls in place the risks to human health during the use of BioShield®75 or ProShield®5000D are negligible.
4.5 I also consider that the risks to the environment from BioShield®75 and ProShield®5000D are negligible with the prescribed controls and the prohibition on application into or onto water in place.
Assessment of risks to Māori and their relationship to the environment
4.6 The potential effect of BioShield®75 and ProShield®5000D on the relationship of Māori to the environment has been assessed in accordance with sections 5(b), 6(d) and 8 of the Act. Under these sections all persons exercising functions, powers, and duties under the Act shall:
recognise and provide for the maintenance and enhancement of people and communities to provide for their cultural well-being, and
take into account the relationship of Māori and their culture and traditions with their ancestral lands, water, taonga and the principles of The Treaty of Waitangi (Te Tiriti o Waitangi).
4.7 In consideration of these obligations, the following sections address the impact of BioShield®75 and ProShield®5000D on Māori interests including kaitiakitanga (stewardship), taha hauora (human health), taiao (environment) and Te Tiriti o Waitangi.
4.8 I note that BioShield®75 and ProShield®5000D trigger several hazardous properties that give rise to the potential for cultural risk. Cultural risk includes any negative impacts to taonga species, the environment, and the general health and well-being of individuals and the community. In addition, the introduction and use of hazardous substances has the potential to inhibit the ability of Māori to fulfil their role as kaitiaki.
Taha hauora (human health)
4.9 I note that BioShield®75 and ProShield®5000D trigger several hazardous properties that give rise to the potential for cultural risk on human health e.g. skin and eye irritancy/corrosivity. For these reasons, BioShield®75 and ProShield®500D pose a risk to taha hauora, in particular, the dimensions of taha tinana (physical health and well-being) and taha whanaunga (the responsibility to belong, care for and share in the collective, including relationships and social cohesion).
Mahinga kai (food resources)
4.10 BioShield®75 and ProShield®5000D pose potential risk to aquatic vertebrates. This is a concern in respect of culturally significant species of fish that are an important food source for Māori. If
BioShield®75 or ProShield®5000D enter waterways, there is potential for these substances to
adversely affect taonga food species such as tuna (fresh water eels), inanga (whitebait), koura / kēwai (freshwater cray) or their prey species, for example, kōuraura (shrimp) and piriwai (mayfly). This substance may also potentially harm other culturally significant non-food species such as kōkopu (galaxiids) and toitoi (bullies).
Kupu whakatepe (conclusion)
4.11 In general, the introduction and use of hazardous substances has the potential to inhibit the ability of Māori to fulfil their role as kaitiaki. This is particularly relevant when considering the guardianship of waterways given the ecotoxic nature of some substances to aquatic species and potential risks to human health under prolonged exposure to some substances.
4.12 Based on the information provided, including the use pattern and the controls proposed to be assigned to BioShield®75 and ProShield®5000D, the risks to Māori culture or traditional relationships with the environment are likely to be negligible.
4.13 If BioShield®75 and ProShield®5000D are applied in the proposed manner, I consider that it would not breach the principles of The Treaty of Waitangi, particularly the principle of active protection.
Assessment of risks to society, the community and the market economy
4.14 I have not identified any risks to society, communities or the market economy from the approval of BioShield®75 and ProShield®5000D.
New Zealand’s international obligations
4.15 I have not identified any international obligations that may be impacted by the approval of BioShield®75 and ProShield®5000D.
Assessment of benefits
4.16 These substances provide another tool to control bacteria, mould, fungi and viruses on surfaces. I consider that this would provide health benefits to the community as a whole.
4.17 I am satisfied that the availability of BioShield®75 and ProShield®5000D will provide beneficial economic effects for some businesses with the potential for flow-on effects to local communities and the New Zealand economy, including improved consumer choice and greater market competition.
5 Variation and cost-effectiveness of prescribed controls
Modification of controls under section 77 and 77A of the Act
5.1 Section 77 of the Act allows the prescribed controls to be substituted, added and/or deleted where:
the adverse effects identified for a substance are different from those which would usually be associated with substances with the same hazard classification
the adverse effects cannot be identified for a substance because of the scientific and technical uncertainty in the available information
the benefits of the substance are retained without significantly increasing the adverse effects.
5.2 Section 77A of the Act also allows the EPA to add, vary, substitute, combine or delete controls if such changes are more effective or more cost-effective with respect to managing the use and risks of the substance, or are more likely to achieve their purpose than the prescribed controls.
5.3 I have varied the controls for BioShield®75 and ProShield®5000D as outlined in Table 2 and 3 respectively
Table 2: Justification for the addition of controls and modification to prescribed controls BioShield®75 (see Appendix A for controls)
Control Justification
E2 Maximum application rate, frequency and number of applications per year
Control E2 relates to restrictions on the use of substances in application areas. The default controls require the EPA to set an application rate for a class 9 substance that is to be sprayed on an area of land (or air or water) and for which an EEL has been set. As the substance is not intended for application to an area of land, this control has been deleted.
EM12 Emergency management requirements
This control specifies the emergency management requirements for secondary containment of liquid hazardous substances (or those likely to liquefy in a fire) and pooling substances. However, this control does not allow for dispensation where it is unnecessary for any pipework associated with the stationary container systems to have secondary containment. I have, therefore, varied the emergency management controls to address this.
I consider that the risks associated with the containment of substances which are not class 1 to 5 substances (i.e. do not ignite or explode) are different to those associated with class 1 to 5
Control Justification
substances. Consequently, the secondary containment requirements can be reduced. I consider that these reduced secondary containment measures are adequate to manage the risks of a spillage of BioShield®75, as this substance does not ignite or explode. Therefore, the proposed variation is more cost-effective in terms of managing the risks of the substance.
Water The environmental risk assessment indicates that restrictions on use and application of this substance are necessary to mitigate the risk of death or adverse effects that could present to organisms in the environment. Accordingly, I consider that the application of controls addressing these potential risks will be more effective than the prescribed controls with respect to their effects on the management, application and risks of this substance.
Schedule 8 SCHEDULE 8 OF THE HAZARDOUS SUBSTANCES (DANGEROUS GOODS AND SCHEDULED TOXIC SUBSTANCES) TRANSFER NOTICE 2004
The prescribed controls do not address the risks associated with storage or use of substances within stationary container systems (e.g. tanks). These risks include the potential failure of primary
containment resulting in a large spill of the substance into the environment I have added an additional control. To mitigate the risk when this substance is stored in bulk without consideration of the
equipment it is contained in or the location of that equipment.
Table 3: Justification for the addition of controls and modification to prescribed controls for ProShield®5000D (see Appendix B for controls)
Control Justification
E2 Maximum application rate, frequency and number of applications per year
Control E2 relates to restrictions on the use of substances in application areas. The default controls require the EPA to set an application rate for a class 9 substance that is to be sprayed on an area of land (or air or water) and for which an EEL has been set. As the substance is not intended for application to an area of land, this control has been deleted.
EM12 Emergency management requirements
This control specifies the emergency management requirements for secondary containment of liquid hazardous substances (or those likely to liquefy in a fire) and pooling substances. However, this control does not allow for dispensation where it is unnecessary for any pipework associated with the stationary container systems to have secondary containment. I have, therefore, varied the emergency management controls to address this.
I consider that the risks associated with the containment of substances which are not class 1 to 5 substances (i.e. do not ignite or explode) are different to those associated with class 1 to 5
substances. Consequently, the secondary containment requirements can be reduced. I consider that these reduced secondary containment measures are adequate to manage the risks of a spillage of ProShield®5000D, as this substance does not ignite or explode. Therefore, the proposed variation is more cost-effective in terms of managing the risks of the substance.
Water The environmental risk assessment indicates that restrictions on use and application of this substance are necessary to mitigate the risk of death or adverse effects that could present to organisms in the environment. Accordingly, I consider that the application of controls addressing these potential risks will be more effective than the prescribed controls with respect to their effects on the management, application and risks of this substance.
Control Justification
Schedule 8 SCHEDULE 8 OF THE HAZARDOUS SUBSTANCES (DANGEROUS GOODS AND SCHEDULED TOXIC SUBSTANCES) TRANSFER NOTICE 2004
The prescribed controls do not address the risks associated with storage or use of substances within stationary container systems (e.g. tanks). These risks include the potential failure of primary
containment resulting in a large spill of the substance into the environment I have added an additional control. To mitigate the risk when this substance is stored in bulk without consideration of the
equipment it is contained in or the location of that equipment.
Assessment of control modifications
5.4 I consider that the modifications to the controls under section 77A of the Act fulfil the legislative criteria of being, relative to the prescribed controls:
more effective with respect to their effect on the management, use, and risks of the substance,
more cost-effective in terms of their effect on the management, use, and risks of the substance
more likely to achieve their purpose.
5.5 I have incorporated these controls into Appendices A and B of this document.
Review of controls for cost-effectiveness
5.6 I consider that the proposed controls, provided they are complied with, are the most cost-effective means of managing the identified potential risks associated with this substance.
5.7 The applicant was provided an opportunity to comment on the controls as set out in this decision and no concerns were raised.
6 Decision
6.1 I have considered the effects of this substance throughout its life cycle and the controls that may be imposed on this substance.
6.2 Having considered the composition, hazardous properties and use of BioShield®75 and ProShield®5000D, I am satisfied that it meets the criteria for rapid assessment under section 28A(2)(a) as a substance having a similar composition, and similar hazardous properties have been approved under the Act.
6.3 I have determined that the benefits of this substance outweigh any adverse effects. Therefore, the import of BioShield®75 and ProShield®5000D is approved with controls as listed in Appendix A and B.
Dr Allan L Freeth Date: 12 February 2017
Chief Executive, EPA
Amendment March 2017
Amendment to change the wording of the purpose statement. The purpose statement is now: “To import BioShield®75 and ProShield®5000D for use as bound antimicrobial surface protectants”
Dr Allan L Freeth Date: 22 March 2017
Chief Executive, EPA
Appendix A: Controls applying to BioShield®75
Please refer to the Hazardous Substances Regulations3 for the requirements prescribed for each control.
Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001
Code Regulation Description Variation
T1 11 – 27 Limiting exposure to toxic substances through the setting of ADE, PDE or TEL values
No TEL, ADE or PDE values are set for any component of this substance at this time.
T2 29, 30 Controlling exposure in places of work through the setting of WES values
The EPA adopts as WES values for this substance, and each component of this substance, any applicable value specified in WorkSafe New Zealand’s Workplace Exposure Standards and Biological Exposure Indices Document; 8th Edition;
June 20164.
T4 7 Requirements for equipment used to
handle substances
T7 10 Restrictions on the carriage of toxic or corrosive substances on passenger service vehicles
E1 32 – 45 Limiting exposure to ecotoxic
substances through the setting of EEL values
E6 7 Requirements for equipment used to
handle substances
Hazardous Substances (Identification) Regulations 2001
Code Regulation Description Variation
I1 6, 7, 32 – 35, 36(1) – (7)
Identification requirements, duties of persons in charge, accessibility, comprehensibility, clarity and durability
I3 9 Priority identifiers for ecotoxic substances
I9 18 Secondary identifiers for all hazardous substances
I11 20 Secondary identifiers for ecotoxic substances
3 The regulations can be found on the New Zealand Legislation website: http://www.legislation.co.nz
4 Or any subsequent version of this Standard approved or endorsed by the EPA.
Code Regulation Description Variation I16 25 Secondary identifiers for toxic
substances
I19 29 – 31 Additional information requirements, including situations where substances are in multiple packaging
I21 37 – 39, 47 – 50
General documentation requirements
I23 41 Specific documentation requirements for ecotoxic substances
I28 46 Specific documentation requirements for toxic substances
I29 51, 52 Signage requirements
Hazardous Substances (Packaging) Regulations 2001
Code Regulation Description Variation
P1 5, 6, 7(1), 8 General packaging requirements P3 9 Criteria that allow substances to be
packaged to a standard not meeting Packing Group I, II or III criteria P13 19 Packaging requirements for toxic
substances
PS4 Schedule 4 Packaging requirements as specified in Schedule 4
Hazardous Substances (Disposal) Regulations 2001
Code Regulation Description Variation
D4 8 Disposal requirements for toxic and corrosive substances
D5 9 Disposal requirements for ecotoxic substances
D6 10 Disposal requirements for packages D7 11, 12 Information requirements for
manufacturers, importers and suppliers, and persons in charge D8 13, 14 Documentation requirements for
manufacturers, importers and suppliers, and persons in charge
Hazardous Substances (Emergency Management) Regulations 2001
Code Regulation Description Variation
EM1 6, 7, 9 – 11 Level 1 information requirements for suppliers and persons in charge EM6 8(e) Information requirements for toxic
substances
EM7 8(f) Information requirements for ecotoxic substances EM8 12 – 16, 18 –
20
Level 2 information requirements for suppliers and persons in charge EM11 25 – 34 Level 3 emergency management
requirements: duties of person in charge, emergency response plans EM12 35 – 41 Level 3 emergency management
requirements: secondary containment
The following subclauses are added after subclause (3) of regulation 36:
(4) For the purposes of this regulation, and regulations 37 to 40, where this substance is contained in pipework that is installed and operated so as to manage any loss of containment in the pipework it—
(a) is not to be taken into account in determining whether a place is required to have a secondary containment system; and (b) is not required to be located in a
secondary containment system.
(5) In this clause, pipework—
(a) means piping that—
(i) is connected to a stationary container; and
(ii) is used to transfer a hazardous substance into or out of the stationary
container; and
(b) includes a process pipeline or a transfer line.
The following subclauses are added at the end of regulation 37:
(2) If pooling substances which do not have class 1 to 5 hazard classifications are held in a place above ground in
Code Regulation Description Variation
containers each of which has a capacity of 60 litres or less—
(a) if the place’s total pooling potential is less than 20,000 litres, the secondary containment system must have a capacity of at least 25% of that total pooling potential:
(b) if the place’s total pooling potential is 20,000 litres or more, the secondary containment system must have a capacity of the greater of—
(i) 5% of the total pooling potential; or
(ii) 5,000 litres.
(3) Pooling substances to which subclause (2) applies must be segregated where appropriate to ensure that leakage of one substance may not adversely affect the container of another substance.
The following subclauses are added at the end of regulation 38:
(2) If pooling substances which do not have class 1 to 5 hazard classifications are held in a place above ground in containers 1 or more of which have a capacity of more than 60 litres but none of which have a capacity of more than 450 litres—
(a) if the place’s total pooling potential is less than 20,000 litres, the secondary containment system must have a capacity of either 25% of that total pooling potential or 110% of the capacity of the largest container,
whichever is the greater:
(b) if the place’s total pooling potential is 20,000 litres or more, the secondary containment system must have a capacity of the greater of—
(i) 5% of the total pooling potential; or
Code Regulation Description Variation
(ii) 5,000 litres
(3) Pooling substances to which subclause (2) applies must be segregated where appropriate to ensure that the leakage of one substance may not adversely affect the container of another substance.
EM13 42 Level 3 emergency management
requirements: signage
Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004
Code Regulation Description Variation
Tank Wagon
4 – 43, as applicable
Controls relating to tank wagons and transportable containers
Additional controls
Code Section of
the Act Control
Water 77A This substance must not be applied into or onto water Stationary
Container Systems
Schedule 8 SCHEDULE 8 OF THE HAZARDOUS SUBSTANCES (DANGEROUS GOODS AND SCHEDULED TOXIC SUBSTANCES) TRANSFER NOTICE 2004
This schedule prescribes the controls for stationary container systems. The requirements of this schedule are detailed in the consolidated version of the Hazardous Substances (Dangerous Goods and Schedule Toxic Substances) Transfer Notice 2004, available from http://www.epa.govt.nz/Publications/Transfer- Notice-35-2004.pdf
The following clause replaces Clause 1 of Schedule 8 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004:
This Schedule applies to every stationary container system that contains, or is intended to contain the substance
Appendix B: Controls applying to ProShield®5000D
Please refer to the Hazardous Substances Regulations5 for the requirements prescribed for each control.
Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001
Code Regulation Description Variation
T4 7 Requirements for equipment used to
handle substances
T5 8 Requirements for protective clothing and equipment
T7 10 Restrictions on the carriage of toxic or corrosive substances on passenger service vehicles
E1 32 – 45 Limiting exposure to ecotoxic
substances through the setting of EEL values
E6 7 Requirements for equipment used to
handle substances
Hazardous Substances (Identification) Regulations 2001
Code Regulation Description Variation
I1 6, 7, 32 – 35, 36(1) – (7)
Identification requirements, duties of persons in charge, accessibility, comprehensibility, clarity and durability
I2 8 Priority identifiers for corrosive substances
I3 9 Priority identifiers for ecotoxic substances
I9 18 Secondary identifiers for all hazardous substances
I10 19 Secondary identifiers for corrosive substances
I11 20 Secondary identifiers for ecotoxic substances
I17 26 Use of generic names
I18 27 Requirements for using concentration ranges
5 The regulations can be found on the New Zealand Legislation website: http://www.legislation.co.nz
Code Regulation Description Variation I19 29 – 31 Additional information requirements,
including situations where substances are in multiple packaging
I21 37 – 39, 47 – 50
General documentation requirements
I22 40 Specific documentation requirements for corrosive substances
I23 41 Specific documentation requirements for ecotoxic substances
I29 51, 52 Signage requirements
I30 53 Advertising corrosive and toxic substances
Hazardous Substances (Packaging) Regulations 2001
Code Regulation Description Variation
P1 5, 6, 7(1), 8 General packaging requirements P3 9 Criteria that allow substances to be
packaged to a standard not meeting Packing Group I, II or III criteria P14 20 Packaging requirements for corrosive
substances
P15 21 Packaging requirements for ecotoxic substances
PG3 Schedule 3 Packaging requirements equivalent to UN Packing Group III
Hazardous Substances (Disposal) Regulations 2001
Code Regulation Description Variation
D4 8 Disposal requirements for toxic and corrosive substances
D5 9 Disposal requirements for ecotoxic substances
D6 10 Disposal requirements for packages D7 11, 12 Information requirements for
manufacturers, importers and suppliers, and persons in charge
Code Regulation Description Variation D8 13, 14 Documentation requirements for
manufacturers, importers and suppliers, and persons in charge
Hazardous Substances (Emergency Management) Regulations 2001
Code Regulation Description Variation
EM1 6, 7, 9 – 11 Level 1 information requirements for suppliers and persons in charge EM2 8(a) Information requirements for
corrosive substances EM7 8(f) Information requirements for
ecotoxic substances EM8 12 – 16, 18 –
20
Level 2 information requirements for suppliers and persons in charge EM11 25 – 34 Level 3 emergency management
requirements: duties of person in charge, emergency response plans EM12 35 – 41 Level 3 emergency management
requirements: secondary containment
The following subclauses are added after subclause (3) of regulation 36:
(4) For the purposes of this regulation, and regulations 37 to 40, where this substance is contained in pipework that is installed and operated so as to manage any loss of containment in the pipework it—
(a) is not to be taken into account in determining whether a place is required to have a secondary containment system; and (b) is not required to be located in a
secondary containment system.
(5) In this clause, pipework—
(a) means piping that—
(i) is connected to a stationary container; and
(ii) is used to transfer a hazardous substance into or out of the stationary
container; and
(b) includes a process pipeline or a transfer line.
Code Regulation Description Variation
The following subclauses are added at the end of regulation 37:
(2) If pooling substances which do not have class 1 to 5 hazard classifications are held in a place above ground in containers each of which has a capacity of 60 litres or less—
(a) if the place’s total pooling potential is less than 20,000 litres, the secondary containment system must have a capacity of at least 25% of that total pooling potential:
(b) if the place’s total pooling potential is 20,000 litres or more, the secondary containment system must have a capacity of the greater of—
(i) 5% of the total pooling potential; or
(ii) 5,000 litres.
(3) Pooling substances to which subclause (2) applies must be segregated where appropriate to ensure that leakage of one substance may not adversely affect the container of another substance.
The following subclauses are added at the end of regulation 38:
(2) If pooling substances which do not have class 1 to 5 hazard classifications are held in a place above ground in containers 1 or more of which have a capacity of more than 60 litres but none of which have a capacity of more than 450 litres—
(a) if the place’s total pooling potential is less than 20,000 litres, the secondary containment system must have a capacity of either 25% of that total pooling potential or 110% of the capacity of the largest container,
whichever is the greater:
(b) if the place’s total pooling potential is 20,000 litres or more,
Code Regulation Description Variation
the secondary containment system must have a capacity of the greater of—
(i) 5% of the total pooling potential; or
(ii) 5,000 litres
(3) Pooling substances to which subclause (2) applies must be segregated where appropriate to ensure that the leakage of one substance may not adversely affect the container of another substance.
EM13 42 Level 3 emergency management
requirements: signage
Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004
Code Regulation Description Variation
Tank Wagon
4 – 43, as applicable
Controls relating to tank wagons and transportable containers
Additional controls
Definitions
Unless defined below, terms used in the controls have the same meaning as defined in the Act or regulations made under the Act.
Code Section of
the Act Control
Water 77A This substance must not be applied into or onto water Stationary
Container Systems
Schedule 8 SCHEDULE 8 OF THE HAZARDOUS SUBSTANCES (DANGEROUS GOODS AND SCHEDULED TOXIC SUBSTANCES) TRANSFER NOTICE 2004
This schedule prescribes the controls for stationary container systems. The requirements of this schedule are detailed in the consolidated version of the Hazardous Substances (Dangerous Goods and Schedule Toxic Substances) Transfer Notice 2004, available from http://www.epa.govt.nz/Publications/Transfer- Notice-35-2004.pdf
The following clause replaces Clause 1 of Schedule 8 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004:
This Schedule applies to every stationary container system that contains, or is intended to contain the substance
Term Definition Water
Means water in all its physical forms, whether flowing or not, and whether over or under ground, but does not include water in any form while in a pipe, tank or cistern or water used in the dilution of the substance prior to application.