ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
14 October 2005
Application Code
HSR05059
Application Type
To import or manufacture any hazardous substance
under Section 28 of the Hazardous Substances and New
Organisms (HSNO) Act 1996
Applicant
Mark Bell-Booth Limited
Date Application Received
7 June 2005
Consideration Date
5 October 2005
Considered by
The Hazardous Substances Standing Committee of the
Authority
Purpose of the Application
To import or manufacture a range of large volume
veterinary medicines
1
Summary of Decision
1.1
The application to import or manufacture Olsson’s Bloatiq Molasses Block with Terric
(Olsson’s), FIL Emollient Salve, Ecovet, Uptite, Elthamol and Patten’s Milkeeze is
approved with controls in accordance with the relevant provisions of the Hazardous
Substances and New Organisms Act 1996 (the HSNO Act), the HSNO Regulations, and
the HSNO (Methodology) Order 1998 (the Methodology).
1.2
The substances have been given the following unique identifiers for the ERMA New
Zealand Hazardous Substances Register:
Olsson’s Bloatiq Molasses Block with Terric,
FIL Emollient Salve,
Ecovet,
Uptite,
Elthamol, and
Patten’s Milkeeze
1.3
ERMA New Zealand has adopted the European Union use classification system as the
basis for recording the nature and uses of substances approved. The following use
categories are recorded for these substances:
Main Category:
3
Non-dispersive use
Industrial category:
1
Agricultural industry
Function/Use category:
41
Pharmaceuticals
Subcategory: Veterinary medicines
2
Legislative Criteria for Application
2.1
The application was lodged pursuant to section 28 of the HSNO Act. The decision was
determined in accordance with section 29, taking into account additional matters to be
considered in that section and matters relevant to the purpose of the HSNO Act, as
specified under Part II of the HSNO Act. Unless otherwise stated, references to section
numbers in this decision refer to sections of the HSNO Act.
2.2
Consideration of the application followed the relevant provisions of the Methodology.
Unless otherwise stated, references to clauses in this decision refer to clauses of the
Methodology.
3
Application Process
3.1
The application was formally received on 7 June 2005.
3.2
In accordance with sections 53(1) and 53A, and clauses 2(2)(b) and 7, public
notification was made on 7 June 2005.
3.3
Submissions closed on 19 July 2005.
3.4
Various government departments (including the Ministry of Health and the Department
of Labour Work Place Group, and the New Zealand Food Safety Authority
(Agricultural Compounds and Veterinary Medicines Group), Crown Entities and
interested parties, which in the opinion of the Authority would be likely to have an
interest in the application, were notified of the receipt of the application (sections 53(4)
and 58(1)(c), and clauses 2(2)(e) and 5) and provided with an opportunity to comment
or make a public submission on the application.
3.5
No submissions were received.
3.6
In accordance with section 58, the Authority postponed the consideration of this
application on 12 August 2005, pending finalisation of the advice they sought from the
Agency of ERMA New Zealand.
3.7
No external experts were used in the consideration of this application (clause 17).
3.8
A public hearing was not required to be held.
ERMA New Zealand Decision: Application HSR05059
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3.9
The following members of the Hazardous Substances Standing Committee considered
the application (section 19(2)(b)): Professor George Clark (Chairperson), Mr Tony
Haggerty and Dr Manuka Henare.
3.10
The information available to the Committee comprised:
 The application, including confidential appendices
 The Evaluation and Review (E&R) Report.
 Additional comment from the Agency pertaining to emergency management
controls.
4
Consideration
Purpose of the Application
4.1
The purpose of the application is to import or manufacture a range of large volume
veterinary medicines.
Sequence of the Consideration
4.2
In accordance with clause 24, the approach adopted by the Committee was to:
 Establish the hazard classification for the substances and derive the default controls.
 Identify potentially non-negligible risks, costs, and benefits.
 Assess potentially non-negligible risks, costs, and benefits in the context of the
default controls and possible variations to those controls. Risks were assessed in
accordance with clause 12, and costs and benefits in accordance with clause 13.
 Consider and determine variations to the default controls arising from the
circumstances provided for in sections 77 (3), (4) and (5) and then consolidate
controls.
 Evaluate overall risks, costs, and benefits to reach a decision. The combined impact
of risks, costs and benefits was evaluated in accordance with clause 34, and the costeffectiveness of the application of controls was considered in accordance with
clause 35.
Hazard Classification
4.3
The Committee agreed with the hazard classifications determined by the Agency and
classifies the substances as follows:
Olsson’s Bloatiq Molasses Block with Terric
6.3A Skin Irritant
6.4A Eye Irritant
FIL Emollient Salve and Elthamol
9.1D Aquatic Ecotoxicity
Ecovet
3.1C Flammable Liquid
6.4A Eye Irritation
9.1D Aquatic Ecotoxicity
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Uptite
6.8B Reproductive/Developmental Toxicity
Patten’s Milkeeze
6.5B Skin Sensitisation
9.1D Aquatic Ecotoxicity
Default Controls
4.4
The Committee considered that the E&R Report correctly assigned default controls as
set out in the HSNO Regulations. The default controls were used as the reference for
subsequent consideration of the application; they are identified in the E&R Report
(Table 1, section 8) and are not reproduced here.
Identification of the Significant Risks, Costs and Benefits of the Substance
4.5
The Committee identified potentially non-negligible risks, costs and benefits with
reference to clauses 9 and 11, which incorporate relevant material from sections 2, 5, 6,
and 8.
Risks
4.6
The Committee reviewed the identification of risks made by the applicant and additional
risks identified in the E&R Report.
4.7
Olsson’s Bloatiq Molasses Block with Terric:
Olsson’s Bloatiq Molasses Block with Terric has not been classified as posing any
hazards to the environment. The Committee concludes that this substance does not pose
a risk to the environment.
The human health risks relate to skin irritation and eye irritation. For an effect to occur
to human health the substance would need to be splashed onto skin or into eyes. These
effects could occur throughout the life cycle.
4.8
FIL Emollient Salve and Elthamol:
The environmental risks for these substances relate to aquatic ecotoxicity. These risks
arise from potential spillage of the substances at any stage of their life cycle, resulting
in the substances entering a body of water and causing adverse effects on aquatic
organisms.
FIL Emollient Salve and Elthamol have not been classified as posing any hazards to
human health. The Committee concludes that these substances do not pose a risk to
human health.
4.9
Ecovet:
The environmental risks for this substance relate to aquatic ecotoxicity. These risks
arise from potential spillage of the substances at any stage of the life cycle, resulting in
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the substance entering a body of water and resulting in adverse effects on aquatic
organisms. Additionally, the substance is classified as a flammable liquid and
unintended ignition of the substance at any stage of its lifecycle may pose a risk to the
environment.
The human health risks relate to eye irritation. For an adverse effect to occur to human
health the substance would need to be splashed into eyes. This effect could occur
throughout the lifecycle. Additionally, the substance is classified as a flammable liquid
and unintended ignition of the substance at any stage of its lifecycle may pose a risk to
human health
4.10
Uptite:
Uptite has not been classified as posing any hazards to the environment. The
Committee concludes that this substance does not pose a risk to the environment.
The human health risk relates to reproductive/developmental toxicity. Exposure could
occur at any stage of the substance’s lifecycle in New Zealand. The potential adverse
effects are considered to be most relevant in situations where repeated exposure to the
substance occurs.
4.11
Patten’s Milkeeze:
The environmental risks for this substance relate to aquatic ecotoxicity. These risks
arise from potential spillage of the substance at any stage of the life cycle, resulting in
the substance entering a body of water and resulting in adverse effects on aquatic
organisms.
The human health hazard associated with this substance is skin sensitisation. For an
adverse effect to occur to human health the substance would need to be splashed onto
skin. This effect could occur at any stage during the substance’s lifecycle.
Costs
4.12
A “cost” is defined in Regulation 2 of the Methodology as “the value of a particular
adverse effect expressed in monetary or non-monetary terms”. The Methodology and
the HSNO Act both call for consideration of monetary and non-monetary costs (clause
13 and section 9).
4.13
The Committee is satisfied that there are no significant new or cumulative costs that will
result from the release of these substances.
Benefits
4.14
A “benefit” is defined in Regulation 2 of the Methodology as “the value of a particular
positive effect expressed in monetary or non-monetary terms”. Benefits that may arise
from any of the matters set out in clauses 9 and 11 were considered in terms of clause
13.
4.15
For these substances, the Committee agreed that the benefits put forward by the
applicant, as listed below, if realised, are likely to be significant.
ERMA New Zealand Decision: Application HSR05059
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

Recognising that similar products to the veterinary medicines included in this
application are currently on the market in New Zealand, the approval of these
substances will result in an increase in choice for the primary production sector,
without imposing additional costs
The nature and intended uses of the substances are such that dispersion into the
environment is unlikely and therefore it is unlikely that the substances will pose
any additional risk to the New Zealand environment.
Assessment of the Potentially Non-negligible Risks of the Substance
4.16
The risks assessed were those identified as potentially non-negligible. Risks were
considered in terms of the requirements of clause 12, including the assessment of
consequences and probabilities, the impact of uncertainty and the impact of risk
management.
4.17
The evidence available was largely scientific in nature and was considered in terms of
clause 25(1). This evidence comprised that provided by the applicant and additional
evidence set out in the E&R Report.
4.18
In assessing risk, the Committee gave particular consideration to risks arising from the
significant hazards of the substances i.e. ecotoxicity, and human health effects, and
examined the extent to which exposure to hazard would be mitigated by controls
(clauses 11 and 12).
4.19
The Committee established that risks to human health, the environment, to Māori, to
society, to the economy and to international obligations are negligible to low with the
controls in place.
Assessment of the Potentially Non-negligible Costs and Benefits
4.20
The Methodology and the HSNO Act both call for consideration of monetary and nonmonetary costs (clause 13 and section 9). The potentially non-negligible costs are
discussed in paragraphs 4.12 and 4.13. The Committee is satisfied that there are no
significant costs that will result from the release of these substances.
4.21
The potentially non-negligible benefits are discussed in paragraph 4.16. The Committee
is unable to place an expected value on the benefits (clause 13(b)) but is satisfied that
the ability of the substances to enter the market could give rise to the associated
benefits.
Establishment of the Approach to Risk in the Light of Risk Characteristics
4.22
Clause 33 requires the Authority, when considering applications, to have regard for the
extent to which a specified set of risk characteristics exist. The intention of this
provision is to provide a route for determining how cautious or risk averse the Authority
should be in weighing up risks and costs against benefits.
4.23
In accordance with clause 33, the Committee has established a cautious position in
weighing up risks and costs against benefits due to the potential for skin sensitisation
during the use and manufacture of Patten’s Milkeeze, the potential for
ERMA New Zealand Decision: Application HSR05059
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reproductive/developmental toxicity throughout the lifecycle of Uptite and the potential
for adverse effects to health through unintended ignition of Ecovet.
Overall Evaluation of Risks, Costs and Benefits
4.24
Having regard to clauses 22 and 34 and in accordance with the tests in clause 27 and
section 29, risks, costs and benefits were evaluated taking account of all proposed
controls including default controls plus proposed variations to the controls.
4.25
Clause 34 sets out the approaches available to the Authority in evaluating the combined
impact of risks, costs and benefits, i.e. weighing up risks, costs and benefits.
4.26
The Committee has decided that the substance poses negligible to low risk to the
environment, to human health, to Māori, to society, to the economy and to international
obligations. In accordance with clause 34, the Committee considers the most significant
risks associated with these large volume veterinary medicines primarily involve the
potential for skin sensitisation during the use and manufacture of Patten’s Milkeeze, the
potential for reproductive/developmental toxicity throughout the lifecycle of Uptite and
the potential for adverse effects to health through unintended ignition of Ecovet. As the
Agency considers it improbable and highly improbable that such adverse effects would
occur, and has assessed the risk posed to human health as low, the Agency considers
that level of risk associated with the veterinary medicines included in this application
are outweighed by the benefits
4.27
The Committee has assessed the substances included in this application, other than
Patten’s Milkeeze, Uptite and Ecovet as posing negligible to very low risks to the
environment and human health, and therefore considers that the overall the level of risk
associated with these substances are outweighed by the benefits.
Additional Controls under s77A
4.28
Under section 77A of the HSNO Act, the Authority may impose as controls any
obligations and restrictions that the Authority thinks fit. Before imposing a control
under this section, the Authority must be satisfied that, against any other specified
controls that apply to the substance:
(a) the proposed control is more effective in terms of its effect on the management, use
and risks of the substance; or
(b) the proposed control is more cost-effective in terms of its effect on the management,
use and risks of the substance; or
(c) the proposed control is more likely to achieve its purpose.
4.29
The following control is applied to each of the substances covered in this application:
4.30
“This substance shall only be used as a veterinary medicine.”
4.31
The Committee considers this control is necessary as the risk assessment has only taken
into account the intended use of these substances as veterinary medicines. The
application of the additional control to these substances is consistent with the approval
for the veterinary medicines transferred to the HSNO Act on 1 July 2005.
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4.32
The following additional control is applied to FIL Emollient Salve, Ecovet, Elthamol
and Patten’s Milkeeze:
4.33
The controls relating to stationary container systems, as set out in Schedule 8 of the
Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer
Notice (New Zealand Gazette Issue No 35, 26 March 2004, as amended by Issue No.
128, 1 October 2004, shall apply to this substance, notwithstanding clause 1(1) of those
schedules.
4.34
The Committee notes that, as a means of managing the risks from the veterinary
medicines included in this application, additional controls relating to stationary
container systems are necessary. These provisions are currently provided in Schedules
8 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances)
Transfer Notice 2004 (New Zealand Gazette of 26 March 2004, No. 35, as amended by
No. 128, 1 October 2004).
4.35
The Committee notes that the Authority has varied clause 100 of Schedule 8 for the
veterinary medicines transferred to the HSNO Act on 1 July 2005. The Committee
considers it appropriate that the same variation is applied to Schedule 8 for the
veterinary medicines included in this application. The variation is as follows:
4.36
Clause 100 shall apply to each veterinary medicine included in this application, as if
subclause (1) were omitted and the following substituted:
4.37
“(1) In this Part, existing stationary container system means a stationary container
system to which this Schedule applies that, immediately before 1 July 2005,—
(a) was being used to contain a substance described in Schedule 1 of the
Hazardous Substances (Veterinary Medicines) Transfer Notice 2005; or
(b) was designed to be used to contain a substance described in that Table, and
construction of the stationary container system to that design had
commenced.”
4.38
The Committee considers that these controls are relevant to these substances, and notes
that no other such controls have been specified under the Act. In accordance with
section 77A(4)(a) of the HSNO Act, the Agency is satisfied that imposing these
additional controls is more effective than any other specified controls in terms of their
effect on the management, use and risks of the substances included in this application.
4.39
The Committee has classified Ecovet as a 3.1C flammable liquid and considers that the
following control is applicable to this substance:
4.40
The controls relating to adverse effects of unintended ignition of class 2 and class 3.1
hazardous substances, set out in Schedule 10 of the New Zealand Gazette Notice of
Thursday, 25 March 2004, Issue Number 35, as amended by the New Zealand Gazette
Notice of Friday, 1 October 2004, Issue Number 128, shall apply to Ecovet, as
applicable, notwithstanding clause 1 of the schedule.
4.41
The Committee notes that, as a means of managing the risks from Ecovet, the Act
provides for regulations to be made, prescribing controls relating to adverse effects of
unintended ignition of class 2 and class 3.1 hazardous substances (section 75(1)(b)).
These provisions are currently in the form of controls on dangerous goods in Schedule
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10 of the New Zealand Gazette Notice of Thursday, 25 March 2004, Issue Number 35,
as amended by the New Zealand Gazette Notice of Friday, 1 October 2004, Issue
Number 128.
4.42
The Committee considers that controls relating to adverse effects of unintended ignition
of class 2 and class 3.1 hazardous substances, are necessary to manage Ecovet, and
noted that no other such controls have been specified under the HSNO Act.
Variation of Controls under Section 77
4.43
Under section 77(3), (4) and (5), the default controls determined by the hazardous
properties of the substance may be varied.
4.44
The applicant was given an opportunity to comment on the proposed controls as set out
in the E&R Report (clause 35(b)). No comments were received.
4.45
The Committee decided that the following variations should apply the substances
covered in this application:
4.46
Control T1 relates to limiting exposure to hazardous substances. The Committee notes
that this control is triggered for Patten’s Milkeeze, Ecovet and Uptite. For similar
veterinary medicines that were transferred to the HSNO Act on 1 July 2005 the
Authority omitted the requirement to set tolerable exposure limits (TELs). The
Committee considers that it is appropriate to be consistent with this approach for
Patten’s Milkeeze, Ecovet and Uptite, as it is improbable that human exposure will
result in an appreciable toxic effect. This control is deleted under section 77(4)(a).
4.47
Additionally, control T1 applies to Olsson’s. The Committee considers it highly
improbable that exposure to the substance will result in adverse effects to health. The
Committee considers that the requirements of Regulation 11(1)(c) are not met for this
substance and, therefore, no Acceptable Daily Exposure (ADE) value is required to be
set. Consequently no TEL is set for this substance and control T1 is considered not
applicable to Olsson’s.
4.48
Control T2 relates to controlling exposure in places of work through the setting of
WESs. The Committee notes that the following WES values have been set by The
Department of Labour (Occupation Health and Safety) for components of the large
volume veterinary medicines and adopts these WES values:
Olsson’s Bloatiq Molasses Block with Terric
•
Component B TWA = 100 ppm and 525 mg/m3
•
Component D TWA = 10 mg/m3
•
Component E TWA = 2 mg/m3
•
Component G TWA = 1 mg/m3
Ecovet
•
Component A TWA = 1,000ppm and 1,880 mg/m3
Patten's Milkeeze
•
Component C TWA = 5 mg/m3
•
Component C STEL = 10 mg/m3
ERMA New Zealand Decision: Application HSR05059
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4.49
The Committee notes that there are no WES values set for any components of Uptite
and in the absence of industrial hygiene data for this substance the Committee is unable
to calculate a WES value. The Committee deletes control T2 for Uptite as no WES for
this substance, or its components can be calculated.
4.50
Control T4 relates to the requirements for equipment used to handle hazardous
substances. The Committee notes that this control is triggered for Olsson’s and that this
control has been varied by the Authority for similar veterinary medicines transferred to
the HSNO Act on 1 July 2005, so that it does not apply at the stage at which they are
dispensed or administered to an animal. The Committee considers that this control
variation is equally applicable to Olsson’s as no equipment is used during the
administration of these substances to animals and it is very unlikely that the use of these
substances will lead to adverse effects to human health. Additionally, the risks posed by
this substance to users have been assessed as low. This control is varied so that it does
not apply at the stage at which Olsson’s is dispensed or administered to an animal under
section 77(4)(b).
4.51
Controls T4 and E6 both relate to requirements for equipment used to handle hazardous
substances. Both of these controls are triggered for Ecovet and Patten’s Milkeeze. These
controls are combined under section 77(5) for Ecovet and Patten’s Milkeeze.
4.52
Control T5 relates to the requirements for protective clothing and equipment. The
Committee notes that this control is triggered for Olsson’s. The Committee notes that
this control has been deleted by the Authority for similar veterinary medicines
transferred to the HSNO Act on 1 July 2005 at the stage at which they are dispensed or
administered to an animal. The Committee considers that this control is equally
applicable to Olsson’s as it is very unlikely that the use of this substance will lead to
adverse effects to human health. Additionally, the risks posed by this substance to users
have been assessed as low. This control is varied, under section 77(4)(b), so that it does
not apply to Olsson’s at the stage at which it is dispensed or administered to an animal.
4.53
Control T7 relates to restrictions on the carriage of hazardous substances on passenger
service vehicles and is triggered for Olsson’s. Given the nature of the product (15 kg
block), the likelihood of an adverse effect to health occurring, and consequent level of
the risk posed to health, the Committee considers that it appropriate to delete this
control under section 77(4)(a) for Olsson’s. This approach is consistent with the
previous approval of another molasses based block (ERMA New Zealand approval
code: HSR001519) used for bloat control in cattle.
4.54
Control T7 is applicable to Patten’s Milkeeze. The maximum quantity per package of
this substance that may be carried on a passenger service vehicle is 0.5 kg, which is
triggered by the skin sensitisation classification (6.5B). The Committee notes that this
maximum quantity has been varied to 1 kg by the Authority for similar veterinary
medicines that were transferred to the HSNO Act on 1 July 2005. Similarly, the
Committee has varied the maximum quantity for Patten’s Milkeeze, under section
77(4)(b). This variation is considered appropriate by the Committee, as the risk
assessment for this substance has identified that it is improbable that an incident would
occur during transport that would lead to adverse effects to health.
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4.55
Control I16 relates to secondary identifiers for toxic substances. The Committee notes
that this control applies to Olsson’s and has been varied by the Authority for similar
veterinary medicines transferred to the HSNO Act on 1 July 2005 so it applies as if the
substances were not skin or eye irritants. Similarly, the Committee has varied this
control in the same way, for Olsson’s, and noting that skin and eye irritation are the only
toxic thresholds triggered for Olsson’s deletes this control under section 77(4)(a). The
Committee considers the risk posed by this substance to human health as insignificant to
very low and does not consider that removing secondary identifiers will increase the
risk to human health.
4.56
Control I29 relates to signage requirements. This control is triggered for Patten’s
Milkeeze, Elthamol and FIL Emollient Salve. The Committee notes that the Authority
has varied regulation 52 (signage requirements) of the Hazardous Substances
(Identification) Regulations 2001 for similar veterinary medicines transferred to the
HSNO Act on 1 July 2005 so that the following substitution of words occurred:
“at every vehicular and pedestrian access to the building, and every vehicular and
pedestrian access to land where the building is located”
in subclause (1) were omitted and the following substituted:
", in the case of a building where milking animals are milked, at the primary human
entrance to the building, or in all other cases, at every vehicular and pedestrian access
to the building"
Additionally, where those hazardous substances are located in a building where milking
animals are milked, subclause (2) of regulation 52 was omitted. The Committee applies
the same variations to Patten’s Milkeeze, FIL Emollient Salve and Elthamol. The
Committee considers that the substitution of words makes the control relevant for the
intended use of the substances and the omissions of subclause (2), where Patten’s
Milkeeze, Elthamol and FIL Emollient Salve are located in a building where milking
animals are milked, will not increase the risk to the environment as it is considered
highly improbable that environmental exposure would occur at this stage of the
substances lifecycles.
4.57
Control E1 relates to the requirements to set an Environmental Exposure Limit (EEL).
The Committee notes that this control as been triggered for Patten’s Milkeeze, Ecovet,
Elthamol and FIL Emollient Salve, and that the Authority has deleted the requirement to
set an EEL for similar veterinary medicines transferred to the HSNO Act on 1 July
2005. The Committee has deleted this requirement for Patten’s Milkeeze, Ecovet,
Elthamol and FIL Emollient Salve under section 77(4)(a) as these substances have been
assessed as posing an insignificant risk to the environment throughout their lifecycles.
4.58
Controls D2, D4 and D5 are combined for Ecovet under section 77(5) as they all relate
to the disposal of the substance.
4.59
Controls D4 and D5 are combined under section 77(5) for Patten’s Milkeeze as they
both relate to the disposal requirements for these substances.
4.60
Controls codes P3 and P13 both relate to packaging requirements for Olsson’s. These
two controls are combined under section 77(5) for this substance.
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4.61
Control codes P3, P5 and P13 are combined for Ecovet as they all relate to packaging
requirements for the substance. The Committee varies the requirements of control P5 to
those of a 3.1D substance to reflect the United Nations Transport of Dangerous Goods
position applicable to this substance. Therefore, the requirements of Control P5 are not
applicable to Ecovet and packaging requirements for this substance are prescribed by
controls P3 and P13. Controls P3 and P13 are combined under section 77(5).
Recommendations
4.62
The Committee recommends that, should inappropriate or accidental use, transport or
disposal of the veterinary medicine included in this application result in the
contamination of waterways, the appropriate authorities, including the relevant iwi
authorities in the region, should be notified. This action should include advising them
of the contamination and the measures taken in response.
Environmental User Charges
4.63
The Committee considers that use of controls on the veterinary medicine included in
this application is an effective means of managing risks associated with this substance.
At this time no consideration has been given to whether or not environmental charges
should be applied to this substance as an alternative or additional means of achieving
effective risk management.
5
Decision
5.1
Pursuant to section 29 of the HSNO Act, the Committee has considered this application
to import hazardous substances made under section 28 of the HSNO Act.
5.2
The Committee is satisfied that the default controls, as varied in paragraphs 4.29 to
4.61, will be adequate to manage the adverse effects of the hazardous substances.
5.3
Having considered all the possible effects of the hazardous substances in accordance
with section 29 of the HSNO Act, pursuant to clause 27 of the Methodology, based on
consideration and analysis of the information provided, and taking into account the
application of controls, the view of the Committee is that the substances pose negligible
to low risks to the environment and to human health and safety, and it is concluded that
the benefits associated with the substances outweigh the risks and costs.
5.4
In accordance with clause 36(2)(b) of the Methodology the Committee records that, in
reaching this conclusion, it has applied the balancing tests in section 29 of the HSNO
Act and clause 27 of the Methodology.
5.5
It has also applied the following criteria in the Methodology:
 clause 9 - equivalent of sections 5, 6 and 8;
 clause 11 – characteristics of substance;
 clause 12 – evaluation of assessment of risks;
 clause 13 – evaluation of assessment of costs and benefits;
 clause 14 – costs and benefits accruing to New Zealand
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
5.6
clause 21 – the decision accords with the requirements of the HSNO Act and
regulations;
clause 22 – the evaluation of risks, costs and benefits – relevant considerations;
clause 24 – the use of recognised risk identification, assessment, evaluation and
management techniques;
clause 25 – the evaluation of risks;
clause 27 – risks and costs are outweighed by benefits;
clause 33 – risk characteristics;
clause 34 – the aggregation and comparison of risks, costs and benefits; and
clause 35 – the costs and benefits of varying the default controls.
The application for importation and manufacture of the hazardous substances Olsson’s
Bloatiq Molasses Block with Terric (Olsson’s), FIL Emollient Salve, Ecovet, Uptite,
Elthamol and Patten’s Milkeeze is thus approved, with controls as detailed in Appendix
1.
Professor George Clark
Date 14 October 2005
Chair Hazardous Substances Committee
ERMA New Zealand Approval Codes:
Olsson’s Bloatiq Molasses
Block with Terric:
FIL Emollient Salve:
Ecovet:
Uptite:
Elthamol:
Patten’s Milkeeze:
HSR001731
HSR001732
HSR001733
HSR001734
HSR001735
HSR001736
ERMA New Zealand Decision: Application HSR05059
Page 13 of 62
Appendix 1: List of Controls for the Large Volume
Veterinary Medicine Products Included in this
Application
Control Codes and Explanations for Olsson’s Bloatiq Molasses Black with Terric
Control
Code1
Regulation2
Explanation3
Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 -Toxic Property Controls
T2
29, 30
Controlling exposure in places of work
A workplace exposure standard (WES) is designed to protect persons in the
workplace from the adverse effects of toxic substances. A WES is an
airborne concentration of a substance (expressed as mg substance/m3 of air or
ppm in air), which must not be exceeded in a workplace and applies to every
place of work.
The following WES values apply to Olsson’s Bloatiq Molasses Block
with Terric:
Component B TWA = 100 ppm and 525 mg/m3
Component D TWA = 10 mg/m3
Component E TWA = 2 mg/m3
Component G TWA = 1 mg/m3
T4
7
Requirements for equipment used to handle hazardous substances
Any equipment used to handle Olsson’s Bloatiq Molasses Block with Terric
must retain and/or dispense the substance in the manner intended, i.e. without
leakage, and must be accompanied by sufficient information so that this can
be achieved.
This control does not apply to Olsson’s Bloatiq Molasses Block with
Terric when the substance is being dispensed or administered to an
animal.
T5
8
Requirements for protective clothing and equipment
Protective clothing/equipment must be employed when Olsson’s Bloatiq
Molasses Block with Terric is being handled. The clothing/equipment must
be designed, constructed and operated to ensure that the person does not
come into contact with the substance and is not directly exposed to a
concentration of the substances that is greater than the WES for that
substance.
The person in charge must ensure that people using the protective
clothing/equipment have access to sufficient information specifying how the
clothing/equipment may be used, and the requirements for maintaining the
clothing/equipment.
This control does not apply to Olsson’s Bloatiq Molasses Block with
1
Note: The numbering system used in this column relates to the coding system used in the ERMA New Zealand Controls Matrix. This links the
hazard classification categories to the regulatory controls triggered by each category. It is available from the ERMA New Zealand website
www.ermanz.govt.nz/resources and is also contained in the ERMA New Zealand User Guide to the HSNO Control Regulations.
2
These Regulations form the controls applicable to this substance. Refer to the cited Regulations for the formal specification, and for definitions
and exemptions. The accompanying explanation is intended for guidance only.
3
These explanations are for guidance only. Refer to the cited Regulations for the formal specification, and for definitions and exemptions.
ERMA New Zealand Decision: Application HSR05059
Page 14 of 62
Control
Code1
Regulation2
Explanation3
Terric when the substance is being dispensed or administered to an
animal.
Hazardous Substances (Identification) Regulations 2001
The Identification Regulations prescribe requirements with regard to
identification of Olsson’s Bloatiq Molasses Block with Terric in terms of:
 information that must be “immediately available” with the substance
(priority and secondary identifiers). This information is generally
provided by way of the product label
 documentation that must be available in the workplace, generally
provided by way of MSDS
 signage at a place where there is a large quantity of the substance.
I1
6, 7, 32-35, 36 General identification requirements
(1)-(7)
These controls relate to the duties of suppliers and persons in charge of
Olsson’s Bloatiq Molasses Block with Terric with respect to identification
(essentially labelling) (Regulations 6 and 7), accessibility of the required
information (Regulations 32 and 33) and presentation of the required
information with respect to comprehensibility, clarity and durability
(Regulations 34, 35, 36(1)-(7))
Regulation 6 – Identification duties of suppliers
Suppliers of Olsson’s Bloatiq Molasses Block with Terric must ensure it is
labelled with all relevant priority identifier information (as required by
Regulations 8-17) and secondary identifier information (as required by
Regulations 18-30) before supplying it to any other person. This includes
ensuring that the priority identifier information is available to any person
handling the substance within two seconds (Regulation 32), and the
secondary identifier information available within 10 seconds (Regulation
33).
Suppliers must also ensure that no information is supplied with the substance
(or its packaging) that suggests it belongs to a class or subclass that it does
not in fact belong to.
Regulation 7 – Identification duties of persons in charge
Persons in charge of Olsson’s Bloatiq Molasses Block with Terric must
ensure it is labelled with all relevant priority identifier information (as
required by Regulations 8 to 17) and secondary identifier information (as
required by Regulations 18 to 30) before supplying it to any other person.
This includes ensuring that the priority identifier information is available to
any person handling the substance within two seconds (Regulation 32), and
the secondary identifier information available within 10 seconds (Regulation
33).
Persons in charge must also ensure that no information is supplied with the
substance (or its packaging) that suggests it belongs to a class or subclass that
it does not in fact belong to.
Regulations 32 and 33 – Accessibility of information
All priority identifier Information (as required by Regulations 8 to 17) must
be available within two seconds, eg. on the label
All secondary identifier Information (as required by Regulations 18 to 30)
must be available within 10 seconds, eg. on the label.
ERMA New Zealand Decision: Application HSR05059
Page 15 of 62
Control
Code1
Regulation2
I9
18
I19
29-31
Explanation3
Regulations 34, 35, 36(1)-(7) – Comprehensibility, Clarity and Durability of
information
All required priority and secondary identifiers must be presented in a way
that meets the performance standards in these Regulations. In summary:
 any information provided (either written and oral) must be readily
understandable and in English
 any information provided in written or pictorial form must be able to be
easily read or perceived by a person with average eyesight under normal
lighting conditions
 any information provided in an audible form must be able to be easily
heard by a person with average hearing
 any information provided must be in a durable format i.e. the information
requirements with respect to clarity must be able to be met throughout
the lifetime of the (packaged) substance under the normal conditions of
storage, handling and use.
Secondary identifiers for all hazardous substances
This control relates to detail required for Olsson’s Bloatiq Molasses Block
with Terric on the product label. This information must be accessible within
10 seconds (Regulation 33) and could be provided on secondary panels on
the product label. The following information is required:
 an indication (which may include its common name, chemical name, or
registered trade name) that unequivocally identifies it, and
 enough information to enable its New Zealand importer, supplier, or
manufacturer to be contacted, either in person or by telephone, and
 in the case of a substance which, when in a closed container, is likely to
become more hazardous over time or develop additional hazardous
properties, or become a hazardous substance of a different class or
subclass, a description of each likely change and the date by which it is
likely to occur.
Alternative information in certain cases
Regulation 29 – Substances in fixed bulk containers or bulk transport
containers
This Regulation relates to alternative ways of presenting the priority and
secondary identifier information required by Regulations 8 to 25 when
Olsson’s Bloatiq Molasses Block with Terric is contained in fixed bulk
containers or bulk transport containers.
Regulation 29(1) specifies that for fixed bulk containers, it is sufficient
compliance if there is available at all times to people near the container,
information that identifies the type and general degree of hazard of the
substance.
Regulation 29(2) specifies that for bulk transport containers, it is sufficient
compliance if the substance is labelled or marked in compliance with the
requirements of the Land Transport Rule 45001, Civil Aviation Act 1990 or
Maritime Transport Act 1994.
Regulation 30 – Substances in multiple packaging
This Regulation relates to situations when Olsson’s Bloatiq Molasses Block
with Terric is in multiple packaging and the outer packaging obscures some
or all of the required substance information. In such cases, the outer
packaging must:
 be clearly labelled with all relevant priority identifier information i.e. the
hazardous properties of the substance must be identified, or
ERMA New Zealand Decision: Application HSR05059
Page 16 of 62
Control
Code1
I21
Regulation2
37-39, 47-50
Explanation3
 be labelled or marked in compliance with either the Land Transport Rule
45001, Civil Aviation Act 1990 or the Maritime Safety Act 1994 as
relevant, or
 in the case of an ecotoxic substance, it must bear the EU pictogram
“Dangerous to the Environment” (‘dead fish and tree’ on orange
background), or
 bear the relevant class or subclass label assigned by the UN Model
Regulations.
Regulation 31 – Alternative information when substances are imported
This Regulation relates to alternative information requirements for Olsson’s
Bloatiq Molasses Block with Terric that is imported into New Zealand in a
closed package or in a freight container and will be transported to their
destination without being removed from that package or container. In these
situations, it is sufficient compliance with HSNO if the package or container
is labelled or marked in compliance with the requirements of the Land
Transport Rule 45001.
Documentation required in places of work
These controls relate to the duties of suppliers and persons in charge of
places of work with respect to provision of documentation (essentially
Material Safety Data Sheets) (Regulations 37, 38 and 50); the general content
requirements of the documentation (Regulation 39 and 47); the accessibility
and presentation of the required documentation with respect to
comprehensibility and clarity (Regulation 48).
These controls are triggered when Olsson’s Bloatiq Molasses Block with
Terric is held in the workplace in quantities equal to or greater than 50 kg
Regulation 37 – Documentation duties of suppliers
A supplier must provide documentation containing all relevant information
required by Regulations 39 to 48 when selling or supplying to another person
a quantity of a Olsson’s Bloatiq Molasses Block with Terric equal to or
greater than 50 kg, if the substance is to be used in a place of work and the
supplier has not previously provided the documentation to that person.
Regulation 38 – Documentation duties of persons in charge of places of work
The person in charge of any place of work where Olsson’s Bloatiq Molasses
Block with Terric is present in quantities equal to or greater than those
specified in Regulation 38 (and with reference to Schedule 2 of the
Identification Regulations), must ensure that every person handling the
substance has access to the documentation required for each hazardous
substance concerned. The person in charge must also ensure that the
documentation does not contain any information that suggests that the
substance belongs to a class or subclass it does not in fact belong to.
Regulation 39 – General content requirements for documentation
The documentation provided with Olsson’s Bloatiq Molasses Block with
Terric must include the following information:
 the unequivocal identity of the substance (eg. the CAS number, chemical
name, common name, UN number, registered trade name(s))
 a description of the physical state, colour and odour of the substance
 if the substance’s physical state may alter over the expected range of
workplace temperatures, the documentation must include a description of
ERMA New Zealand Decision: Application HSR05059
Page 17 of 62
Control
Code1
Regulation2
Explanation3
the temperatures at which the changes in physical state may occur and
the nature of those changes.
 in the case of a substance that, when in a closed container, is likely to
become more hazardous over time or develop additional hazardous
properties, or become a hazardous substance of a different class, the
documentation must include a description of each likely change and the
date by which it is likely to occur
 contact details for the New Zealand supplier/manufacturer/importer
 all emergency management and disposal information required for the
substance
 the date on which the documentation was prepared
Regulation 47 – Information not included in approval
This Regulation relates to the provision of specific documentation
information (eg. as provided on an MSDS). If information required by
Regulations 39 to 46 was not included in the information used for the
approval of the substance by the Authority, it is sufficient compliance with
those Regulations if reference is made to that information requirement along
with a comment indicating that such information is not applicable to that
substance.
Regulation 48 – Location and presentation requirements for documentation
All required documentation must be available to a person handling the
substance in a place of work within 10 minutes. The documentation must be
readily understandable by any fully-trained worker required to have access to
it and must be easily read, under normal lighting conditions, at a distance of
not less than 0.3m.
Regulation 49 – Documentation requirements for vehicles
This Regulation provides for the option of complying with documentation
requirements as specified in the various Land, Sea and Air transport rules
when the substance is being transported.
I28
46
Regulation 50 – Documentation to be supplied on request
Notwithstanding Regulation 37 above, a supplier must provide the required
documentation to any person in charge of a place of work (where a hazardous
substance is present) if asked to do so by that person.
Specific documentation requirements for toxic substances
The documentation provided with Olsson’s Bloatiq Molasses Block with
Terric must include the following information:
 its general degree and type of toxic hazard
 a full description of the circumstances in which it may harm human
beings
 the kinds of harm it may cause to human beings
 a full description of the steps to be taken to prevent harm to human
beings
 a summary of the available acute and chronic (toxic) data used to define
the (toxic) subclass or subclasses in which it is classified
 the symptoms or signs of injury or ill health associated with each likely
route of exposure
 the dose, concentration, or conditions of exposure likely to cause injury
or ill health
ERMA New Zealand Decision: Application HSR05059
Page 18 of 62
Control
Code1
Regulation2
Explanation3
 any WESs set by the Authority.
Hazardous Substances (Packaging) Regulations 2001
P1
5, 6, 7 (1), 8
General packaging requirements
These controls relate to the ability of the packaging to retain its contents,
allowable packaging markings with respect to design approvals, factors
affecting choice of suitable packaging, and compatibility of the substance
with any previous contents of the packaging.
Regulation 5 – Ability to retain contents
Packaging for Olsson’s Bloatiq Molasses Block with Terric must ensure that,
when the package is closed, there is no visible release of the substance, and
that it maintains its ability to retain its contents in temperatures from –10oC
to +50oC. The packaging must also maintain its ability to retain its remaining
contents if part of the contents is removed from the package and the
packaging is then re-closed. The packaging in direct contact with the
substance must not be significantly affected or weakened by contact with the
substance such that the foregoing requirements cannot be met.
Regulation 6 – Packaging markings
Packages containing Olsson’s Bloatiq Molasses Block with Terric must not
be marked in accordance with the UN Model Regulations unless:
 the markings comply with the relevant provisions of that document, and
 the packaging complies with the tests set out in Schedule 1, 2 or 3
(Packaging Regulations) respectively, and
 the design of the packaging has been test certified as complying with
those tests.
Regulation 7(1) – Requirements when packing hazardous substance
 When packing Olsson’s Bloatiq Molasses Block with Terric, account
must be taken of its physical state and properties, and packaging must be
selected that complies with the requirements of Regulation 5, and
Regulations 9 to 21.
Regulation 8 – Compatibility
Olsson’s Bloatiq Molasses Block with Terric must not be packed in
packaging that has been previously packed with substances with which it is
incompatible unless all traces of the previous substance have been removed.
Regulation 9A and 9B – Large Packaging
Large packaging may be used to contain hazardous substances in New
Zealand if it has been constructed, marked and tested as a large package as
provided in Chapter 6.6 of the 13th revised edition of the UNRTDG, 2003.
P3 and
P13
9 and 19
“Large Packaging” does not include:
 a tank, tank wagon or transportable container (as defined in the
Hazardous Substances (Tank Wagons and Transportable Containers)
Regulations 2004, or
 a stationary container system, a stationary tank or a tank (as defined in
the Hazardous substances (Dangerous Goods and Scheduled Toxic
Substances) Transfer Notice 2004.
Packaging requirements for substances packed in limited quantities
When Olsson’s Bloatiq Molasses Block with Terric is packaged in limited
ERMA New Zealand Decision: Application HSR05059
Page 19 of 62
Control
Code1
Regulation2
Explanation3
quantities of 400 kg or less, there is provision for it to be packaged to a
lesser performance standard than normally required (as specified in Schedule
4 of the Packaging Regulations).
Any Olsson’s Bloatiq Molasses Block with Terric that is offered for sale in a
package of less than 2.5kg must be in child resistant packaging (i.e. toxic
substances liable to be in homes). However, if the substance is for use in a
place of work to which children do not have access, this requirement is not
mandatory.
PS4
Schedule 4
This schedule describes the minimum packaging requirements that must be
complied with for this substance.
Hazardous Substances (Disposal) Regulations 2001
D4
8
Disposal requirements for Olsson’s Bloatiq Molasses Block with Terric
Olsson’s Bloatiq Molasses Block with Terric must be disposed of by:
 treating the substance so that it is no longer a hazardous substance,
including depositing the substance in a landfill, incinerator or sewage
facility. However, this does not include dilution of the substance with
any other substance prior to discharge to the environment; or
 exporting the substance from New Zealand as a hazardous waste.
D6
10
Disposal requirements for packages
This control gives the disposal requirements for packages that contained
Olsson’s Bloatiq Molasses Block with Terric and are no longer to be used for
that purpose. Such packages must be either decontaminated/treated or
rendered incapable of containing any substance (hazardous or otherwise) and
then disposed of in a manner that is consistent with the disposal requirements
for the substance. In addition, the manner of disposal must take into account
the material that the package is manufactured from.
D7
11, 12
Disposal information requirements
These controls relate to the provision of information concerning disposal
(essentially on the label) that must be provided when selling or supplying a
quantity of Olsson’s Bloatiq Molasses Block with Terric that exceeds 0.1 kg.
D8
13, 14
Information must be provided on appropriate methods of disposal and
information may be supplied warning of methods of disposal that should be
avoided, i.e. that would not comply with the Disposal Regulations. Such
information must be accessible to a person handling the substance within 10
seconds and must comply with the requirements for comprehensibility,
clarity and durability as described in Regulations 34-36 of the Identification
Regulations (code I1).
Disposal documentation requirements
These controls relate to the provision of documentation concerning disposal
(essentially in a MSDS) that must be provided when selling or supplying a
quantity of a hazardous substance that exceeds 50 kg.
The documentation must describe one or more methods of disposal (that
comply with the Disposal Regulations) and describe any precautions that
must be taken. Such documentation must be accessible to a person handling
the substance at a place of work within 10 minutes and must comply with
the requirements for comprehensibility and clarity as described in
Regulations 48(2), (3) and (4) of the Identification Regulations (code I21).
ERMA New Zealand Decision: Application HSR05059
Page 20 of 62
Control
Code1
Regulation2
Explanation3
Hazardous Substances (Emergency Management) Regulations 2001
EM1
6, 7, 9-11
Level 1 emergency management information: General requirements
These controls relate to the provision of emergency management information
(essentially on the label) that must be provided with Olsson’s Bloatiq
Molasses Block with Terric when present in quantities equal to or greater
than 0.1 kg.
Regulation 6 describes the duties of suppliers, Regulation 7 describes the
duties of persons in charge of places, Regulation 9 describes the requirement
for the availability of the information (10 seconds) and Regulation 10 gives
the requirements relating to the presentation of the information with respect
to comprehensibility, clarity and durability. These requirements correspond
with those relating to secondary identifiers required by the Identification
Regulations (code I1, Regulations 6, 7, 32–35, 36(1)-(7)).
EM6
8(e)
EM8
12-16, 18-20
Regulation 11 provides for the option of complying with the information
requirements of the transport rules when the substance is being transported.
Information requirements for toxic substances
The following information must be provided when Olsson’s Bloatiq
Molasses Block with Terric is present in quantities equal to or greater than
0.1 kg:
 a description of the first aid to be given
 a 24-hour emergency service telephone number.
Level 2 emergency management information requirements
These controls relate to the duties of suppliers and persons in charge of
places of work with respect to the provision of emergency management
documentation (essentially Material Safety Data Sheets). This
documentation must be provided where Olsson’s Bloatiq Molasses Block
with Terric is sold or supplied, or held in a workplace, in quantities equal to
or greater than 50 kg.
Regulations 12 and 13 describe the duties of suppliers, regulation 14
describes the duties of persons in charge of places of work, regulation 15
provides for the option of complying with documentation requirements of the
transport rules when the substance is being transported, and regulation 16
specifies requirements for general contents of the documentation.
Regulation 18 prescribes location and presentation requirements for the
documentation, i.e. it must be available within 10 minutes, be readily
understandable, comprehensible and clear. These requirements correspond
with those relating to documentation required by the Identification
regulations (code I21).
Controls under section 77A
This substance shall only be used as a veterinary medicine.
ERMA New Zealand Decision: Application HSR05059
Page 21 of 62
Control Codes and Explanations for FIL Emollient Salve and Elthamol
Control
Code4
Regulation5
Explanation6
Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 - Ecotoxic Property Controls
E6
7
Requirements for equipment used to handle hazardous substances
Any equipment used to FIL Emollient Salve or Elthamol must retain and/or
dispense the substance in the manner intended, i.e. without leakage, and must
be accompanied by sufficient information so that this can be achieved.
Hazardous Substances (Identification) Regulations 2001
The Identification Regulations prescribe requirements with regard to
identification of FIL Emollient Salve and Elthamol in terms of:
 information that must be “immediately available” with the substance
(priority and secondary identifiers). This information is generally
provided by way of the product label
 documentation that must be available in the workplace, generally
provided by way of MSDS
 signage at a place where there is a large quantity of the substance.
I1
6, 7, 32-35, 36 General identification requirements
(1)-(7)
These controls relate to the duties of suppliers and persons in charge of
hazardous substances with respect to identification (essentially labelling)
(Regulations 6 and 7), accessibility of the required information (Regulations
32 and 33) and presentation of the required information with respect to
comprehensibility, clarity and durability (Regulations 34, 35, 36(1)-(7))
Regulation 6 – Identification duties of suppliers
Suppliers of FIL Emollient Salve or Elthamol must ensure it is labelled with
all relevant priority identifier information (as required by Regulations 8-17)
and secondary identifier information (as required by Regulations 18-30)
before supplying it to any other person. This includes ensuring that the
priority identifier information is available to any person handling the
substance within two seconds (Regulation 32), and the secondary identifier
information available within 10 seconds (Regulation 33).
Suppliers must also ensure that no information is supplied with the substance
(or its packaging) that suggests it belongs to a class or subclass that it does
not in fact belong to.
Regulation 7 – Identification duties of persons in charge
Persons in charge of FIL Emollient Salve or Elthamol must ensure it is
labelled with all relevant priority identifier information (as required by
Regulations 8 to 17) and secondary identifier information (as required by
Regulations 18 to 30) before supplying it to any other person. This includes
ensuring that the priority identifier information is available to any person
handling the substance within two seconds (Regulation 32), and the
secondary identifier information available within 10 seconds (Regulation
33).
Persons in charge must also ensure that no information is supplied with the
4
Note: The numbering system used in this column relates to the coding system used in the ERMA New Zealand Controls Matrix. This links the
hazard classification categories to the regulatory controls triggered by each category. It is available from the ERMA New Zealand website
www.ermanz.govt.nz/resources and is also contained in the ERMA New Zealand User Guide to the HSNO Control Regulations.
5
These Regulations form the controls applicable to this substance. Refer to the cited Regulations for the formal specification, and for definitions
and exemptions. The accompanying explanation is intended for guidance only.
6
These explanations are for guidance only. Refer to the cited Regulations for the formal specification, and for definitions and exemptions.
ERMA New Zealand Decision: Application HSR05059
Page 22 of 62
Control
Code4
Regulation5
Explanation6
substance (or its packaging) that suggests it belongs to a class or subclass that
it does not in fact belong to.
Regulations 32 and 33 – Accessibility of information
All priority identifier Information (as required by Regulations 8 to 17) must
be available within two seconds, eg. on the label
All secondary identifier Information (as required by Regulations 18 to 30)
must be available within 10 seconds, eg. on the label.
I9
18
I11
20
I19
29-31
Regulations 34, 35, 36(1)-(7) – Comprehensibility, Clarity and Durability of
information
All required priority and secondary identifiers must be presented in a way
that meets the performance standards in these Regulations. In summary:
 any information provided (either written and oral) must be readily
understandable and in English
 any information provided in written or pictorial form must be able to be
easily read or perceived by a person with average eyesight under normal
lighting conditions
 any information provided in an audible form must be able to be easily
heard by a person with average hearing
 any information provided must be in a durable format i.e. the information
requirements with respect to clarity must be able to be met throughout
the lifetime of the (packaged) substance under the normal conditions of
storage, handling and use.
Secondary identifiers for all hazardous substances
This control relates to detail required for FIL Emollient Salve and Elthamol
on the product label. This information must be accessible within 10 seconds
(Regulation 33) and could be provided on secondary panels on the product
label. The following information is required:
 an indication (which may include its common name, chemical name, or
registered trade name) that unequivocally identifies it, and
 enough information to enable its New Zealand importer, supplier, or
manufacturer to be contacted, either in person or by telephone, and
 in the case of a substance which, when in a closed container, is likely to
become more hazardous over time or develop additional hazardous
properties, or become a hazardous substance of a different class or
subclass, a description of each likely change and the date by which it is
likely to occur.
Secondary identifiers for ecotoxic substances
This control relates to the additional label detail required for FIL Emollient
Salve and Elthamol. This information must be accessible within 10 seconds
(Regulation 33) and could be provided on secondary panels on the product
label. The following information must be provided:
 an indication of the circumstances in which it may harm living organisms
 an indication of the kind and extent of the harm it is likely to cause to
living organisms
 an indication of the steps to be taken to prevent harm to living organisms
Alternative information in certain cases
Regulation 29 – Substances in fixed bulk containers or bulk transport
containers
This Regulation relates to alternative ways of presenting the priority and
secondary identifier information required by Regulations 8 to 25 when
ERMA New Zealand Decision: Application HSR05059
Page 23 of 62
Control
Code4
Regulation5
Explanation6
substances are contained in fixed bulk containers or bulk transport
containers.
Regulation 29(1) specifies that for fixed bulk containers, it is sufficient
compliance if there is available at all times to people near the container,
information that identifies the type and general degree of hazard of the
substance.
Regulation 29(2) specifies that for bulk transport containers, it is sufficient
compliance if the substance is labelled or marked in compliance with the
requirements of the Land Transport Rule 45001, Civil Aviation Act 1990 or
Maritime Transport Act 1994.
Regulation 30 – Substances in multiple packaging
This Regulation relates to situations when FIL Emollient Salve or Elthamol
is in multiple packaging and the outer packaging obscures some or all of the
required substance information. In such cases, the outer packaging must:
 be clearly labelled with all relevant priority identifier information i.e. the
hazardous properties of the substance must be identified, or
 be labelled or marked in compliance with either the Land Transport Rule
45001, Civil Aviation Act 1990 or the Maritime Safety Act 1994 as
relevant, or
 in the case of an ecotoxic substance, it must bear the EU pictogram
“Dangerous to the Environment” (‘dead fish and tree’ on orange
background), or
 bear the relevant class or subclass label assigned by the UN Model
Regulations.
Regulation 31 – Alternative information when substances are imported
This Regulation relates to alternative information requirements for FIL
Emollient Salve or Elthamol that is imported into New Zealand in a closed
package or in a freight container and will be transported to their destination
without being removed from that package or container. In these situations, it
is sufficient compliance with HSNO if the package or container is labelled or
marked in compliance with the requirements of the Land Transport Rule
45001.
I21
37-39, 47-50
Documentation required in places of work
These controls relate to the duties of suppliers and persons in charge of
places of work with respect to provision of documentation (essentially
Material Safety Data Sheets) (Regulations 37, 38 and 50); the general content
requirements of the documentation (Regulation 39 and 47); the accessibility
and presentation of the required documentation with respect to
comprehensibility and clarity (Regulation 48).
These controls are triggered when FIL Emollient Salve or Elthamol is held in
the workplace in quantities equal to or greater than 50 kg.
Regulation 37 – Documentation duties of suppliers
A supplier must provide documentation containing all relevant information
required by Regulations 39 to 48 when selling or supplying to another person
a quantity of FIL Emollient Salve or Elthamol equal to or greater than 50 kg,
if the substance is to be used in a place of work and the supplier has not
previously provided the documentation to that person.
ERMA New Zealand Decision: Application HSR05059
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Control
Code4
Regulation5
Explanation6
Regulation 38 – Documentation duties of persons in charge of places of work
The person in charge of any place of work where FIL Emollient Salve or
Elthamol is present in quantities equal to or greater than those specified in
Regulation 38 (and with reference to Schedule 2 of the Identification
Regulations), must ensure that every person handling the substance has
access to the documentation required for each hazardous substance
concerned. The person in charge must also ensure that the documentation
does not contain any information that suggests that the substance belongs to a
class or subclass it does not in fact belong to.
Regulation 39 – General content requirements for documentation
The documentation provided with FIL Emollient Salve and Elthamol must
include the following information:
 the unequivocal identity of the substance (eg. the CAS number, chemical
name, common name, UN number, registered trade name(s))
 a description of the physical state, colour and odour of the substance
 if the substance’s physical state may alter over the expected range of
workplace temperatures, the documentation must include a description of
the temperatures at which the changes in physical state may occur and
the nature of those changes.
 in the case of a substance that, when in a closed container, is likely to
become more hazardous over time or develop additional hazardous
properties, or become a hazardous substance of a different class, the
documentation must include a description of each likely change and the
date by which it is likely to occur
 contact details for the New Zealand supplier/manufacturer/importer
 all emergency management and disposal information required for the
substance
 the date on which the documentation was prepared
Regulation 47 – Information not included in approval
This Regulation relates to the provision of specific documentation
information (eg. as provided on an MSDS). If information required by
Regulations 39 to 46 was not included in the information used for the
approval of the substance by the Authority, it is sufficient compliance with
those Regulations if reference is made to that information requirement along
with a comment indicating that such information is not applicable to that
substance.
Regulation 48 – Location and presentation requirements for documentation
All required documentation must be available to a person handling the
substance in a place of work within 10 minutes. The documentation must be
readily understandable by any fully-trained worker required to have access to
it and must be easily read, under normal lighting conditions, at a distance of
not less than 0.3m.
Regulation 49 – Documentation requirements for vehicles
This Regulation provides for the option of complying with documentation
requirements as specified in the various Land, Sea and Air transport rules
when the substance is being transported.
Regulation 50 – Documentation to be supplied on request
Notwithstanding Regulation 37 above, a supplier must provide the required
ERMA New Zealand Decision: Application HSR05059
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Control
Code4
Regulation5
I29
51-52
Explanation6
documentation to any person in charge of a place of work (where a hazardous
substance is present) if asked to do so by that person.
Duties of persons in charge of places with respect to signage
These controls specify the requirements for signage, in terms of content,
presentation and positioning at places where FIL Emollient Salve or
Elthamol is held in quantities exceeding 10 000 kg.
Signs are required:
 at every entrance to the building and/or location (vehicular and
pedestrian) where hazardous substances are present
 at each entrance to rooms or compartments where hazardous substances
are present
 immediately adjacent to the area where hazardous substances are located
in an outdoor area.
The information provided in the signage needs to be understandable over a
distance of 10 metres and be sufficient to:
 advise that the location contains hazardous substances
 describe the general type of hazard of each substance (e.g. flammable)
 where the signage is immediately adjacent to the hazardous substance
storage areas, describe the precautions needed to safely manage the
substance (eg. a 'No Smoking' warning near flammable substances).
The following variation to control I29 applies to FIL Emollient Salve
and Elthamol:
The following words
“at every vehicular and pedestrian access to the building, and every
vehicular and pedestrian access to land where the building is located”
in subclause (1) of Regulation 52 are omitted and the following
substituted:
", in the case of a building where milking animals are milked, at the
primary human entrance to the building, or in all other cases, at every
vehicular and pedestrian access to the building"
Where FIL Emollient Salve or Elthamol is located in a building where
milking animals are milked, subclause (2) of regulation 52 does not
apply
Hazardous Substances (Packaging) Regulations 2001
P1
5, 6, 7 (1), 8
General packaging requirements
These controls relate to the ability of the packaging to retain its contents,
allowable packaging markings with respect to design approvals, factors
affecting choice of suitable packaging, and compatibility of the substance
with any previous contents of the packaging.
Regulation 5 – Ability to retain contents
Packaging for FIL Emollient Salve and Elthamol must ensure that, when the
package is closed, there is no visible release of the substance, and that it
maintains its ability to retain its contents in temperatures from –10oC to
+50oC. The packaging must also maintain its ability to retain its remaining
contents if part of the contents is removed from the package and the
packaging is then re-closed. The packaging in direct contact with the
substance must not be significantly affected or weakened by contact with the
ERMA New Zealand Decision: Application HSR05059
Page 26 of 62
Control
Code4
Regulation5
Explanation6
substance such that the foregoing requirements cannot be met.
Regulation 6 – Packaging markings
Packages containing FIL Emollient Salve or Elthamol must not be marked in
accordance with the UN Model Regulations unless:
 the markings comply with the relevant provisions of that document, and
 the packaging complies with the tests set out in Schedule 1, 2 or 3
(Packaging Regulations) respectively, and
 the design of the packaging has been test certified as complying with
those tests.
Regulation 7(1) – Requirements when packing hazardous substance
 When packing FIL Emollient Salve or Elthamol, account must be taken
of its physical state and properties, and packaging must be selected that
complies with the requirements of Regulation 5, and Regulations 9 to 21.
Regulation 8 – Compatibility
FIL Emollient Salve and Elthamol must not be packed in packaging that has
been previously packed with substances with which it is incompatible unless
all traces of the previous substance have been removed.
Regulation 9A and 9B – Large Packaging
Large packaging may be used to contain FIL Emollient Salve or Elthamol in
New Zealand if it has been constructed, marked and tested as a large package
as provided in Chapter 6.6 of the 13th revised edition of the UNRTDG, 2003.
P3
9
“Large Packaging” does not include:
 a tank, tank wagon or transportable container (as defined in the
Hazardous Substances (Tank Wagons and Transportable Containers)
Regulations 2004, or
 a stationary container system, a stationary tank or a tank (as defined in
the Hazardous substances (Dangerous Goods and Scheduled Toxic
Substances) Transfer Notice 2004.
Packaging requirements for substances packed in limited quantities
When substances of FIL Emollient Salve or Elthamol are packaged in
quantities of 400 kg or less, there is provision for them to be packaged to a
lesser performance standard than normally required (as specified in Schedule
4 of the Packaging Regulations).
In addition, there is provision that packages containing less than 0.5 L of FIL
Emollient Salve or Elthamol do not have to comply with the drop test
performance standard contained in Schedule 4 provided the packaging
complies with the requirements of regulations 5(1) (a), (b) and (e), and there
is a warning statement on the outside of the package that the package may
not withstand a drop of 0.5 m [Regulation 9 (3), (4), and (5)].
PS4
Schedule 4
This schedule describes the minimum packaging requirements that must be
complied with for this substance.
Hazardous Substances (Disposal) Regulations 2001
D5
9
Disposal requirements for ecotoxic substances
FIL Emollient Salve and Elthamol must be disposed of by:
 treating the substance so that it is no longer a hazardous substance,
ERMA New Zealand Decision: Application HSR05059
Page 27 of 62
Control
Code4
Regulation5
D6
10
D7
11, 12
D8
13, 14
Explanation6
including depositing the substance in a landfill, incinerator or sewage
facility. However, this does not include dilution of the substance with
any other substance prior to discharge to the environment; or
 discharging the substance to the environment provided that after
reasonable mixing, the concentration of the substance in any part of the
environment outside the mixing zone does not exceed any EEL
(environmental exposure limit) set by the Authority for that substance; or
 exporting the substance from New Zealand as a hazardous waste
Disposal requirements for packages
This control gives the disposal requirements for packages that contained FIL
Emollient Salve or Elthamol and are no longer to be used for that purpose.
Such packages must be either decontaminated/treated or rendered incapable
of containing any substance (hazardous or otherwise) and then disposed of in
a manner that is consistent with the disposal requirements for the substance.
In addition, the manner of disposal must take into account the material that
the package is manufactured from.
Disposal information requirements
These controls relate to the provision of information concerning disposal
(essentially on the label) that must be provided when selling or supplying a
quantity of FIL Emollient Salve or Elthamol that exceeds 1.0 kg.
Information must be provided on appropriate methods of disposal and
information may be supplied warning of methods of disposal that should be
avoided, i.e. that would not comply with the Disposal Regulations. Such
information must be accessible to a person handling the substance within 10
seconds and must comply with the requirements for comprehensibility,
clarity and durability as described in Regulations 34-36 of the Identification
Regulations (code I1).
Disposal documentation requirements
These controls relate to the provision of documentation concerning disposal
(essentially in a MSDS) that must be provided when selling or supplying a
quantity of FIL Emollient Salve or Elthamol that exceeds 50.0 kg.
The documentation must describe one or more methods of disposal (that
comply with the Disposal Regulations) and describe any precautions that
must be taken. Such documentation must be accessible to a person handling
the substance at a place of work within 10 minutes and must comply with
the requirements for comprehensibility and clarity as described in
Regulations 48(2), (3) and (4) of the Identification Regulations (code I21).
Hazardous Substances (Emergency Management) Regulations 2001
EM1
6, 7, 9-11
Level 1 emergency management information: General requirements
These controls relate to the provision of emergency management information
(essentially on the label) that must be provided with any FIL Emollient Salve
or Elthamol when present in quantities equal to or greater than 1.0 kg.
Regulation 6 describes the duties of suppliers, Regulation 7 describes the
duties of persons in charge of places, Regulation 9 describes the requirement
for the availability of the information (10 seconds) and Regulation 10 gives
the requirements relating to the presentation of the information with respect
to comprehensibility, clarity and durability. These requirements correspond
with those relating to secondary identifiers required by the Identification
Regulations (code I1, Regulations 6, 7, 32–35, 36(1)-(7)).
ERMA New Zealand Decision: Application HSR05059
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Control
Code4
Regulation5
EM7
8(f)
EM8
12-16, 18-20
Explanation6
Regulation 11 provides for the option of complying with the information
requirements of the transport rules when the substance is being transported.
Information requirements for ecotoxic substances
The following information must be provided with FIL Emollient Salve or
Elthamol when present in quantities equal to or greater than 1.0 kg:
 a description of the parts of the environment likely to be immediately
affected by it:
 a description of its typical effects on those parts of the environment
 a statement of any immediate actions that may be taken to prevent the
substance from entering or affecting those parts of the environment.
Level 2 emergency management information requirements
These controls relate to the duties of suppliers and persons in charge of
places of work with respect to the provision of emergency management
documentation (essentially Material Safety Data Sheets). This
documentation must be provided where FIL Emollient Salve or Elthamol are
sold or supplied, or held in a workplace, in quantities equal to or greater than
50 kg.
Regulations 12 and 13 describe the duties of suppliers, regulation 14
describes the duties of persons in charge of places of work, regulation 15
provides for the option of complying with documentation requirements of the
transport rules when the substance is being transported, and regulation 16
specifies requirements for general contents of the documentation.
EM11
EM12
25-34
35-41
Regulation 18 prescribes location and presentation requirements for the
documentation, i.e. it must be available within 10 minutes, be readily
understandable, comprehensible and clear. These requirements correspond
with those relating to documentation required by the Identification
regulations (code I21).
Level 3 emergency management requirements – emergency response
plans
These Regulations relate to the requirement for an emergency response plan
to be available at any place (excluding aircraft or ships) where FIL Emollient
Salve or Elthamol is held (or reasonably likely to be held on occasion) in
quantities greater than 10 000 kg.
The emergency response plan must describe all of the likely emergencies that
may arise from the breach or failure of controls. The type of information that
is required to be included in the plan is specified in Regulations 29 to 30.
Requirements relating to the availability of equipment, materials and people
are provided in Regulation 31, requirements regarding the availability of the
plan are provided in Regulation 32 and requirements for testing the plan are
described in Regulation 33.
Level 3 emergency management requirements – secondary containment
These Regulations relate to the requirement for a secondary containment
system to be installed at any fixed location where FIL Emollient Salve or
Elthamol are held in quantities equal to or greater than 10 000 kg.
Regulation 37 prescribes requirements for places where hazardous
substances are held above ground in containers each holding up to 60L or
less. Regulation 38 prescribes requirements for places where hazardous
substances are held above ground in containers each holding between 60L
and 450L. Regulation 39 prescribes requirements for places where
ERMA New Zealand Decision: Application HSR05059
Page 29 of 62
Control
Code4
Regulation5
EM13
42
Explanation6
hazardous substances are held above ground in containers each holding more
than 450L. Regulation 40 prescribes requirements for places where
hazardous substances are held underground. Regulation 41 prescribes
requirements for secondary containment systems that contain substances of
specific hazard classifications, eg. there is a requirement to prevent
substances from coming into contact with incompatible materials, and a
requirement to exclude energy sources when class 1, 2, 3, 4 or 5 substances
are contained).
Level 3 emergency management requirements – signage
This control relates to the provision of emergency management information
on signage at places where FIL Emollient Salve or Elthamol is held at
quantities equal to or greater than 10 000 kg.
The signage must advise of the action to be taken in an emergency and must
meet the requirements for comprehensibility and clarity as defined in
Regulations 34 and 35 of the Identification Regulations.
Controls under section 77A
This substance shall only be used as a veterinary medicine.
The controls relating to stationary container systems, as set out in Schedule 8 of the Hazardous Substances
(Dangerous Goods and Scheduled Toxic Substances) Transfer Notice (New Zealand Gazette Issue No 35, 26
March 2004, as amended by Issue No. 128, 1 October 2004, shall apply to this substance, notwithstanding
clause 1(1) of that schedule.
Clause 100 shall apply to this substance, as if subclause (1) were omitted and the following substituted:
“(1) In this Part, existing stationary container system means a stationary container system to which this
Schedule applies that, immediately before 1 July 2005,—
(a) was being used to contain a substance described in Schedule 1 of the Hazardous Substances
(Veterinary Medicines) Transfer Notice 2005; or
(b) was designed to be used to contain a substance described in that Table, and construction of the
stationary container system to that design had commenced.”
ERMA New Zealand Decision: Application HSR05059
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Control Codes and Explanations for Ecovet
Control
Code7
Regulation8
Explanation9
Hazardous Substances (Classes 1 to 5 Control Regulations) Regulations 2001 - Flammable Property
Controls
F1
7
General test certification requirements for all class 1 to 5 substances
Where a test certificate is required for a hazardous substance location
holding Ecovet, that test certificate must be issued by an approved test
certifier and must typically be renewed yearly. However, the Authority can,
on request by the persons required to obtain the test certificate, extend the
time period to three years.
F3
55
General limits on flammable substances
Where Ecovet is present at a place for longer than 18 hours, and in a
quantity that exceeds those stated directly below, Ecovet must be held at a
hazardous substance location or transit depot as appropriate.
Quantity beyond which this control applies for closed containers:
500 L in containers greater than 5 L
1 500 L in containers up to and including 5 L.
Quantity beyond which this control applies when use occurring in open
containers;
250 L in containers greater than 5 L
250 L in containers up to an including 250 L.
F5
58, 59
Requirements for hazardous atmosphere zones for class 2.1.1, class 2.1.2
and class 3.1 substances.
There is a requirement to establish a hazardous atmosphere zone wherever
Ecovet is present in the following quantities:
100 L (closed)
25 L (decanting)
5 L (open occasionally)
1 L (if in an open container for continuous use)
The zone must comply with either of the AS/NZS Standards as listed in
Regulation 58(a)-(b) or with an ERMA approved code of practice.
F6
60-70
Regulation 59 discusses the application of other legislation with respect to
electrical systems located within a hazardous atmosphere zone. Specifically,
any controls placed on electrical systems or electrical equipment within a
hazardous atmosphere zone must be consistent with any controls on such
systems/equipment set under other legislation if they are relevant to that
specific location. This is to ensure that any potential ignition sources from
electrical system or electrical equipment are protected or insulated to an
extent that is consistent with the degree of hazard.
Requirements to reduce the likelihood of unintended ignition of class
2.1.1, class 2.1.2 and class 3.1 substances.
These regulations prescribe controls to reduce the likelihood of unintended
ignition of Ecovet. Controls are prescribed with the aim of covering all
foreseeable circumstances in which unintended ignition could take place, and
include:
 placing limits on the proportion of flammable vapour to air to ensure that
7
Note: The numbering system used in this column relates to the coding system used in the ERMA New Zealand Controls Matrix. This links the
hazard classification categories to the regulatory controls triggered by each category. It is available from the ERMA New Zealand website
www.ermanz.govt.nz/resources and is also contained in the ERMA New Zealand User Guide to the HSNO Control Regulations.
8
These Regulations form the controls applicable to this substance. Refer to the cited Regulations for the formal specification, and for definitions
and exemptions. The accompanying explanation is intended for guidance only.
9
These explanations are for guidance only. Refer to the cited Regulations for the formal specification, and for definitions and exemptions.
ERMA New Zealand Decision: Application HSR05059
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Control
Code7
F11
Regulation8
76
Explanation9
the proportion of flammable vapour to air will always be sufficiently
outside the flammable range, so that ignition cannot take place, and
 ensuring that there is insufficient energy available for ignition. This
energy could be in the form of either temperature or ignition energy (e.g.
a spark). Accordingly, the controls provide two approaches to ensure
that there is insufficient energy for ignition:
(1) keeping the temperature of the substance, or the temperature of
any surface in contact with the substance, below 80% of the autoignition temperature of the substance, and
(2) keeping sources of ignition below the minimum ignition energy,
either by removal of the ignition source from any location where
flammable substances are handled, or by protecting the “general”
mass of flammable material from the ignition source, e.g. by
enclosing any ignition sources in an enclosure that will not allow
the propagation of the flame to the outside; or using flameproof
motors especially designed to prevent ignition energy escaping.
It should be noted that any person handling any quantity of Ecovet under any
of regulations 63(4), 65, 67 and 69 must be an approved handler for that
substance, i.e. the trigger quantities that typically activate approved handler
requirements do not apply [Regulation 60(2)].
Segregation of incompatible substances
In order to reduce the likelihood of unintended ignition of Ecovet, there is a
requirement to ensure that the substance does not come into contact with any
incompatible substance or material. There is also a requirement that packages
of incompatible substances are held separately.
Ecovet is incompatible with all class 1, 2, 4 and 5 substances and class
3.2 substances.
F12
77
This regulation does not apply to substances that are located on a vehicle,
ship or aircraft if they are segregated in accordance with the Land Transport
Rules, the Maritime Rules or the Civil Aviation Rules as relevant.
Requirement to establish a hazardous substance location if flammable
substances are present
There is a requirement to establish a hazardous substance location where
Ecovet is present in quantities greater than those specified directly below
and held for a period exceeding 18 hours.
Quantity beyond which this control applies for closed containers:
500 L in containers greater than 5 L
1 500 L in containers up to and including 5 L.
Quantity beyond which this control applies when use occurring in open
containers;
250 L in containers greater than 5 L
250 L in containers up to an including 250 L.
Within such zones, there is a requirement for the person in charge to:
 notify the responsible enforcement authority of the locality and capacity
of the hazardous substance location
 where relevant, ensure that the substances will be under the control of an
approved handler and that the requirements of regulation 56 are met
ERMA New Zealand Decision: Application HSR05059
Page 32 of 62
Control
Code7
Regulation8
F14
81
Explanation9
 ensure that any location test certification requirements are met
 ensure that a site plan is available for inspection
 establish and manage a hazardous atmosphere zone when required (as
prescribed by regulation 58)
Test certification requirements for facilities where class 2.1.1, 2.1.2 or
3.1 substances are present
There is a test certification requirement when Ecovet is present at any
hazardous substance location in quantities above the following:
Quantity beyond which this control applies for closed containers:
500 L in containers greater than 5 L
1 500 L in containers up to and including 5 L.
Quantity beyond which this control applies when use occurring in open
containers;
250 L in containers greater than 5 L
250 L in containers up to an including 250 L.
F16
83
That test certificate must be issued by an approved test certifier and must
demonstrate compliance with a number of specified controls, including:
 ensuring that the responsible enforcement authority has been notified of
the locality and capacity of the hazardous substance location
 approved handler requirements
 security requirements
 hazardous atmosphere zone requirements, including controls on
electrical systems and electrical equipment
 segregation of incompatible substances
 signage requirements
 emergency management requirements, including fire-fighting equipment,
emergency response plans and secondary containment
 ensuring that a site plan is available for inspection
Controls on transit depots where flammable substances are present
Transit depots are places designed to hold Ecovet (in containers that remain
unopened) for a period of up to three days, but for periods that are more than
18 hours.
Whenever Ecovet is held at a transit depot in quantities exceeding the levels
specified below there is a requirement for the person in charge to:
 notify the responsible enforcement authority of the locality and capacity
of the hazardous substance location
 where relevant, ensure that the substances will be under the control of an
approved handler
 ensure that any road vehicle loaded with containers of class 2, 3 or 4
substances is not less than 3 m from any other vehicle or container
containing compatible hazardous substances, and not less than 5 m from
any other vehicle or container containing incompatible hazardous
substances,
 ensure that containers of class 2, 3 or 4 substances held in the transit
depot (but not loaded onto a vehicle) are not less than 5 m from
containers of incompatible substances
 ensure that all class 2, 3 or 4 substances remain in their containers and
the containers remain closed
 ensure the safety of any electrical equipment
ERMA New Zealand Decision: Application HSR05059
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Control
Code7
Regulation8
Explanation9
 comply with any signage requirements
 comply with relevant parts of other Acts and Regulations, eg. Electricity
Act 1992, HSE (Mining Underground Regulations) 1999 or Civil
Aviation Rules.
Quantity beyond which this control applies for closed containers:
500 L in containers greater than 5 L
1 500 L in containers up to and including 5 L.
Quantity beyond which this control applies when use occurring in open
containers;
250 L in containers greater than 5 L
250 L in containers up to an including 250 L.
Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 -Toxic Property Controls
T2
29, 30
Controlling exposure in places of work
A workplace exposure standard (WES) is designed to protect persons in the
workplace from the adverse effects of toxic substances. A WES is an
airborne concentration of a substance (expressed as mg substance/m3 of air
or ppm in air), which must not be exceeded in a workplace and applies to
every place of work.
The following WES value applies to Ecovet:
Component A TWA = 1,000ppm and 1,880 mg/m3
T4 and E6 7
Requirements for equipment used to handle hazardous substances
Any equipment used to handle Ecovet must retain and/or dispense the
substance in the manner intended, i.e. without leakage, and must be
accompanied by sufficient information so that this can be achieved.
T7, F2
10, 8
Restrictions on the carriage of hazardous substances on passenger
service vehicles
In order to limit the potential for public exposure to Ecovet, the maximum
quantity per package of Ecovet permitted to be carried on passenger service
vehicles is 1.0 L.
Hazardous Substances (Identification) Regulations 2001
The Identification Regulations prescribe requirements with regard to
identification of Ecovet in terms of:
 information that must be “immediately available” with the substance
(priority and secondary identifiers). This information is generally
provided by way of the product label
 documentation that must be available in the workplace, generally
provided by way of MSDS
 signage at a place where there is a large quantity of the substance.
I1
6, 7, 32-35, 36 General identification requirements
(1)-(7)
These controls relate to the duties of suppliers and persons in charge of
Ecovet with respect to identification (essentially labelling) (Regulations 6
and 7), accessibility of the required information (Regulations 32 and 33) and
presentation of the required information with respect to comprehensibility,
clarity and durability (Regulations 34, 35, 36(1)-(7))
Regulation 6 – Identification duties of suppliers
Suppliers of Ecovet must ensure it is labelled with all relevant priority
identifier information (as required by Regulations 8-17) and secondary
identifier information (as required by Regulations 18-30) before supplying it
to any other person. This includes ensuring that the priority identifier
information is available to any person handling the substance within two
seconds (Regulation 32), and the secondary identifier information available
ERMA New Zealand Decision: Application HSR05059
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Control
Code7
Regulation8
Explanation9
within 10 seconds (Regulation 33).
Suppliers must also ensure that no information is supplied with the substance
(or its packaging) that suggests it belongs to a class or subclass that it does
not in fact belong to.
Regulation 7 – Identification duties of persons in charge
Persons in charge of Ecovet must ensure it is labelled with all relevant
priority identifier information (as required by Regulations 8 to 17) and
secondary identifier information (as required by Regulations 18 to 30) before
supplying it to any other person. This includes ensuring that the priority
identifier information is available to any person handling the substance
within two seconds (Regulation 32), and the secondary identifier
information available within 10 seconds (Regulation 33).
Persons in charge must also ensure that no information is supplied with the
substance (or its packaging) that suggests it belongs to a class or subclass
that it does not in fact belong to.
Regulations 32 and 33 – Accessibility of information
All priority identifier Information (as required by Regulations 8 to 17) must
be available within two seconds, eg. on the label
All secondary identifier Information (as required by Regulations 18 to 30)
must be available within 10 seconds, eg. on the label.
I5
I9
11
18
Regulations 34, 35, 36(1)-(7) – Comprehensibility, Clarity and Durability of
information
All required priority and secondary identifiers must be presented in a way
that meets the performance standards in these Regulations. In summary:
 any information provided (either written and oral) must be readily
understandable and in English
 any information provided in written or pictorial form must be able to be
easily read or perceived by a person with average eyesight under normal
lighting conditions
 any information provided in an audible form must be able to be easily
heard by a person with average hearing
 any information provided must be in a durable format i.e. the information
requirements with respect to clarity must be able to be met throughout
the lifetime of the (packaged) substance under the normal conditions of
storage, handling and use.
Priority identifiers for flammable substances
This requirement specifies that Ecovet must be prominently identified as
being flammable. In addition, the following information must be provided:
 an indication of whether the substance is a gas, aerosol, liquid or solid
 if a flammable liquid, information must be provided on its general degree
of hazard (eg. flammable)
This information must be available to any person handling the substance
within two seconds (Regulation 32) and can be provided by way of signal
headings or commonly understood pictograms on the label.
Secondary identifiers for all hazardous substances
This control relates to detail required for Ecovet on the product label. This
information must be accessible within 10 seconds (Regulation 33) and could
be provided on secondary panels on the product label. The following
ERMA New Zealand Decision: Application HSR05059
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Control
Code7
Regulation8
I11
20
I13
22
I19
29-31
Explanation9
information is required:
 an indication (which may include its common name, chemical name, or
registered trade name) that unequivocally identifies it, and
 enough information to enable its New Zealand importer, supplier, or
manufacturer to be contacted, either in person or by telephone, and
 in the case of a substance which, when in a closed container, is likely to
become more hazardous over time or develop additional hazardous
properties, or become a hazardous substance of a different class or
subclass, a description of each likely change and the date by which it is
likely to occur.
Secondary identifiers for ecotoxic substances
This control relates to the additional label detail required for Ecovet. This
information must be accessible within 10 seconds (Regulation 33) and could
be provided on secondary panels on the product label. The following
information must be provided:
 an indication of the circumstances in which it may harm living
organisms
 an indication of the kind and extent of the harm it is likely to cause to
living organisms
 an indication of the steps to be taken to prevent harm to living organisms
Secondary identifiers for flammable substances
This control relates to the additional label detail required for Ecovet. This
information must be accessible within 10 seconds (Regulation 33) and could
be provided on secondary panels on the product label. The following
information must be provided:
 an indication of its general type and degree of flammable hazard (eg.
flammable liquid)
 an indication of the circumstances in which it may be ignited
unintentionally
 an indication of the likely effect of an unintentional ignition
 an indication of the steps to be taken to prevent an unintentional ignition.
Alternative information in certain cases
Regulation 29 – Substances in fixed bulk containers or bulk transport
containers
This Regulation relates to alternative ways of presenting the priority and
secondary identifier information required by Regulations 8 to 25 when
substances are contained in fixed bulk containers or bulk transport
containers.
Regulation 29(1) specifies that for fixed bulk containers, it is sufficient
compliance if there is available at all times to people near the container,
information that identifies the type and general degree of hazard of the
substance.
Regulation 29(2) specifies that for bulk transport containers, it is sufficient
compliance if the substance is labelled or marked in compliance with the
requirements of the Land Transport Rule 45001, Civil Aviation Act 1990 or
Maritime Transport Act 1994.
Regulation 30 – Substances in multiple packaging
This Regulation relates to situations when Ecovet are in multiple packaging
and the outer packaging obscures some or all of the required substance
information. In such cases, the outer packaging must:
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Control
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I21
Regulation8
37-39, 47-50
Explanation9
 be clearly labelled with all relevant priority identifier information i.e. the
hazardous properties of the substance must be identified, or
 be labelled or marked in compliance with either the Land Transport Rule
45001, Civil Aviation Act 1990 or the Maritime Safety Act 1994 as
relevant, or
 in the case of an ecotoxic substance, it must bear the EU pictogram
“Dangerous to the Environment” (‘dead fish and tree’ on orange
background), or
 bear the relevant class or subclass label assigned by the UN Model
Regulations.
Regulation 31 – Alternative information when substances are imported
This Regulation relates to alternative information requirements for Ecovet
that are imported into New Zealand in a closed package or in a freight
container and will be transported to their destination without being removed
from that package or container. In these situations, it is sufficient
compliance with HSNO if the package or container is labelled or marked in
compliance with the requirements of the Land Transport Rule 45001.
Documentation required in places of work
These controls relate to the duties of suppliers and persons in charge of
places of work with respect to provision of documentation (essentially
Material Safety Data Sheets) (Regulations 37, 38 and 50); the general
content requirements of the documentation (Regulation 39 and 47); the
accessibility and presentation of the required documentation with respect to
comprehensibility and clarity (Regulation 48).
These controls are triggered when Ecovet is held in the workplace in
quantities equal to or greater than 5 L.
Regulation 37 – Documentation duties of suppliers
A supplier must provide documentation containing all relevant information
required by Regulations 39 to 48 when selling or supplying to another person
a quantity of Ecovet equal to or greater than 5 L, if the substance is to be
used in a place of work and the supplier has not previously provided the
documentation to that person.
Regulation 38 – Documentation duties of persons in charge of places of work
The person in charge of any place of work where Ecovet is present in
quantities equal to or greater than those specified in Regulation 38 (and with
reference to Schedule 2 of the Identification Regulations), must ensure that
every person handling the substance has access to the documentation
required for each hazardous substance concerned. The person in charge must
also ensure that the documentation does not contain any information that
suggests that the substance belongs to a class or subclass it does not in fact
belong to.
Regulation 39 – General content requirements for documentation
The documentation provided with a Ecovet must include the following
information:
 the unequivocal identity of the substance (eg. the CAS number, chemical
name, common name, UN number, registered trade name(s))
 a description of the physical state, colour and odour of the substance
 if the substance’s physical state may alter over the expected range of
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Control
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Regulation8
Explanation9
workplace temperatures, the documentation must include a description of
the temperatures at which the changes in physical state may occur and
the nature of those changes.
 in the case of a substance that, when in a closed container, is likely to
become more hazardous over time or develop additional hazardous
properties, or become a hazardous substance of a different class, the
documentation must include a description of each likely change and the
date by which it is likely to occur
 contact details for the New Zealand supplier/manufacturer/importer
 all emergency management and disposal information required for the
substance
 the date on which the documentation was prepared
Regulation 47 – Information not included in approval
This Regulation relates to the provision of specific documentation
information (eg. as provided on an MSDS). If information required by
Regulations 39 to 46 was not included in the information used for the
approval of the substance by the Authority, it is sufficient compliance with
those Regulations if reference is made to that information requirement along
with a comment indicating that such information is not applicable to that
substance.
Regulation 48 – Location and presentation requirements for documentation
All required documentation must be available to a person handling the
substance in a place of work within 10 minutes. The documentation must be
readily understandable by any fully-trained worker required to have access to
it and must be easily read, under normal lighting conditions, at a distance of
not less than 0.3m.
Regulation 49 – Documentation requirements for vehicles
This Regulation provides for the option of complying with documentation
requirements as specified in the various Land, Sea and Air transport rules
when the substance is being transported.
I25
43
I28
46
Regulation 50 – Documentation to be supplied on request
Notwithstanding Regulation 37 above, a supplier must provide the required
documentation to any person in charge of a place of work (where a
hazardous substance is present) if asked to do so by that person.
Specific documentation requirements for flammable substances
The documentation provided with Ecovet must include the following
information:
 its general degree and type of hazard
 a full description of the circumstances in which it may be ignited
unintentionally
 the likely effect of an unintentional ignition
 a full description of the steps to be taken to prevent an unintentional
ignition
 its lower and upper explosive limits, expressed as volume percentages in
air or its flash point (and flash point methodology) and auto-ignition
temperature
Specific documentation requirements for toxic substances
The documentation provided with Ecovet must include the following
information:
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Control
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Regulation8
I29
51-52
Explanation9
 its general degree and type of toxic hazard (e.g. eye irritant)
 a full description of the circumstances in which it may harm human
beings
 the kinds of harm it may cause to human beings
 a full description of the steps to be taken to prevent harm to human
beings
 if it will be a liquid during its use, the percentage of volatile substance in
the liquid formulation, and the temperature at which the percentages
were measured
 a summary of the available acute and chronic (toxic) data used to define
the (toxic) subclass or subclasses in which it is classified
 the symptoms or signs of injury or ill health associated with each likely
route of exposure
 the dose, concentration, or conditions of exposure likely to cause injury
or ill health
 any WESs set by the Authority.
Duties of persons in charge of places with respect to signage
These controls specify the requirements for signage, in terms of content,
presentation and positioning at places where Ecovet is held in quantities
exceeding 1 000 L.
Signs are required:
 at every entrance to the building and/or location (vehicular and
pedestrian) where hazardous substances are present
 at each entrance to rooms or compartments where hazardous substances
are present
 immediately adjacent to the area where hazardous substances are located
in an outdoor area.
The information provided in the signage needs to be understandable over a
distance of 10 metres and be sufficient to:
 advise that the location contains hazardous substances
 describe the general type of hazard of each substance (e.g. flammable)
 where the signage is immediately adjacent to the hazardous substance
storage areas, describe the precautions needed to safely manage the
substance (eg. a 'No Smoking' warning near flammable substances).
Hazardous Substances (Packaging) Regulations 2001
P1
5, 6, 7 (1), 8
General packaging requirements
These controls relate to the ability of the packaging to retain its contents,
allowable packaging markings with respect to design approvals, factors
affecting choice of suitable packaging, and compatibility of the substance
with any previous contents of the packaging.
Regulation 5 – Ability to retain contents
Packaging for Ecovet must ensure that, when the package is closed, there is
no visible release of the substance, and that it maintains its ability to retain its
contents in temperatures from –10oC to +50oC. The packaging must also
maintain its ability to retain its remaining contents if part of the contents is
removed from the package and the packaging is then re-closed. The
packaging in direct contact with the substance must not be significantly
affected or weakened by contact with the substance such that the foregoing
requirements cannot be met.
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Control
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Regulation8
Explanation9
Regulation 6 – Packaging markings
Packages containing Ecovet must not be marked in accordance with the UN
Model Regulations unless:
 the markings comply with the relevant provisions of that document, and
 the packaging complies with the tests set out in Schedule 1, 2 or 3
(Packaging Regulations) respectively, and
 the design of the packaging has been test certified as complying with
those tests.
Regulation 7(1) – Requirements when packing hazardous substance
 When packing Ecovet, account must be taken of its physical state and
properties, and packaging must be selected that complies with the
requirements of Regulation 5, and Regulations 9 to 21.
Regulation 8 – Compatibility
Ecovet must not be packed in packaging that has been previously packed
with substances with which it is incompatible unless all traces of the
previous substance have been removed.
Regulation 9A and 9B – Large Packaging
Large packaging may be used to contain Ecovet in New Zealand if it has
been constructed, marked and tested as a large package as provided in
Chapter 6.6 of the 13th revised edition of the UNRTDG, 2003.
P3, P5,
P13
9
“Large Packaging” does not include:
 a tank, tank wagon or transportable container (as defined in the
Hazardous Substances (Tank Wagons and Transportable Containers)
Regulations 2004, or
 a stationary container system, a stationary tank or a tank (as defined in
the Hazardous substances (Dangerous Goods and Scheduled Toxic
Substances) Transfer Notice 2004.
Packaging requirements for substances packed in limited quantities
When Ecovet is packaged in quantities of 450 L or less, there is provision
for it to be packaged to a lesser performance standard than normally required
(as specified in Schedule 4 of the Packaging Regulations).
In addition, there is provision that packages containing less than 0.5 L of
Ecovet do not have to comply with the drop test performance standard
contained in Schedule 4 provided the packaging complies with the
requirements of regulations 5(1) (a), (b) and (e), and there is a warning
statement on the outside of the package that the package may not withstand a
drop of 0.5 m [Regulation 9 (3), (4), and (5)].
Any Ecovet that is offered for sale in a package of less than 2.5 L must be in
child resistant packaging (i.e. toxic substances liable to be in homes).
However, if the substance is for use in a place of work to which children do
not have access, this requirement is not mandatory.
PS4
Schedule 4
This schedule describes the minimum packaging requirements that must be
complied with for this substance.
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Control
Code7
Regulation8
Explanation9
Hazardous Substances (Disposal) Regulations 2001
D2, D4
6, 8 and 9
Disposal requirements for Ecovet
and D5
As provided by section 77(5), the disposal requirements for toxic, ecotoxic
and flammable substances have been combined. These substances must be
disposed of by:

treating the substance so that it is no longer a hazardous substance.

exporting the substance from New Zealand as a hazardous waste

treatment can include controlled burning providing the performance
requirements as set out in regulation 6 (3)(b) of the Disposal Regulations
for protecting people and the environment are met, and the burning
operation does not exceed any TELs or EELs

treatment includes discharge into the environment as waste, or depositing
in a landfill, provided the discharge location is managed so that
 the substance will not at any time come into contact with any
substances with explosive or oxidising properties, and

there is no ignition source in the vicinity of the disposal site, and
 in the event of an accidental fire, harm to people or the environment
does not occur – the performance requirements for this are set out in
regulation 6 (3)(b) of the Disposal Regulations, and
D6
10
D7
11, 12
D8
13, 14
 after reasonable mixing, the concentration of the substance in any
part of the environment outside the mixing zone does not exceed any
TELs or EELs set by the Authority for that substance However, this
does not include dilution of the substance with any other substance prior
to discharge to the environment
Disposal requirements for packages
This control gives the disposal requirements for packages that contained
Ecovet and are no longer to be used for that purpose. Such packages must be
either decontaminated/treated or rendered incapable of containing any
substance (hazardous or otherwise) and then disposed of in a manner that is
consistent with the disposal requirements for the substance. In addition, the
manner of disposal must take into account the material that the package is
manufactured from.
Disposal information requirements
These controls relate to the provision of information concerning disposal
(essentially on the label) that must be provided when selling or supplying a
quantity of Ecovet that exceeds 0.1 L.
Information must be provided on appropriate methods of disposal and
information may be supplied warning of methods of disposal that should be
avoided, i.e. that would not comply with the Disposal Regulations. Such
information must be accessible to a person handling the substance within 10
seconds and must comply with the requirements for comprehensibility,
clarity and durability as described in Regulations 34-36 of the Identification
Regulations (code I1).
Disposal documentation requirements
These controls relate to the provision of documentation concerning disposal
(essentially in a MSDS) that must be provided when selling or supplying a
quantity of Ecovet that exceeds 5.0 L.
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Control
Code7
Regulation8
Explanation9
The documentation must describe one or more methods of disposal (that
comply with the Disposal Regulations) and describe any precautions that
must be taken. Such documentation must be accessible to a person handling
the substance at a place of work within 10 minutes and must comply with
the requirements for comprehensibility and clarity as described in
Regulations 48(2), (3) and (4) of the Identification Regulations (code I21).
Hazardous Substances (Emergency Management) Regulations 2001
EM1
6, 7, 9-11
Level 1 emergency management information: General requirements
These controls relate to the provision of emergency management information
(essentially on the label) that must be provided with Ecovet when present in
quantities equal to or greater than 0.1 L.
Regulation 6 describes the duties of suppliers, Regulation 7 describes the
duties of persons in charge of places, Regulation 9 describes the requirement
for the availability of the information (10 seconds) and Regulation 10 gives
the requirements relating to the presentation of the information with respect
to comprehensibility, clarity and durability. These requirements correspond
with those relating to secondary identifiers required by the Identification
Regulations (code I1, Regulations 6, 7, 32–35, 36(1)-(7)).
EM6
8(e)
EM7
8(f)
EM8
12-16, 18-20
Regulation 11 provides for the option of complying with the information
requirements of the transport rules when the substance is being transported.
Information requirements for toxic substances
The following information must be provided when Ecovet is present in
quantities equal to or greater than 0.1 L:
 a description of the first aid to be given
 a 24-hour emergency service telephone number.
Information requirements for ecotoxic substances
The following information must be provided with Ecovet when present in
quantities equal to or greater than 1.0 L:
 a description of the parts of the environment likely to be immediately
affected by it:
 a description of its typical effects on those parts of the environment
 a statement of any immediate actions that may be taken to prevent the
substance from entering or affecting those parts of the environment.
Level 2 emergency management information requirements
These controls relate to the duties of suppliers and persons in charge of
places of work with respect to the provision of emergency management
documentation (essentially Material Safety Data Sheets). This
documentation must be provided where Ecovet is sold or supplied, or held in
a workplace, in quantities equal to or greater than 5.0 L.
Regulations 12 and 13 describe the duties of suppliers, regulation 14
describes the duties of persons in charge of places of work, regulation 15
provides for the option of complying with documentation requirements of the
transport rules when the substance is being transported, and regulation 16
specifies requirements for general contents of the documentation.
Regulation 18 prescribes location and presentation requirements for the
documentation, i.e. it must be available within 10 minutes, be readily
understandable, comprehensible and clear. These requirements correspond
with those relating to documentation required by the Identification
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Control
Code7
Regulation8
EM9
17
EM10
21-24
EM11
EM12
EM13
25-34
35-41
42
Explanation9
regulations (code I21).
Specific documentation requirements for flammable and oxidising
substances and organic peroxides
There is an additional requirement for Ecovet that a description be provided
of the steps to be taken to control any fire involving the substance, including
the types of extinguishant to be used.
Fire extinguishers
Every place (including vehicles) where Ecovet is held in a place of work in
quantities exceeding 500 L, must have the specified number of fire
extinguishers (two) (Regulation 21). The intention of these general
requirements is to provide sufficient fire-fighting capacity to stop a fire
spreading and reaching hazardous substances, rather than providing
sufficient capacity to extinguish any possible fire involving large quantities
of hazardous substances.
Each fire extinguisher must be located within 30m of the substance, or, in a
transportation situation, in or on the vehicle (Regulation 22). The
performance measure for an extinguisher is that it must be capable of
extinguishing a fully ignited pool of flammable liquid (50mm deep and at
least 6m2 in area), before the extinguisher is exhausted, and when used by
one person (Regulation 23).
Level 3 emergency management requirements – emergency response
plans
These Regulations relate to the requirement for an emergency response plan
to be available at any place (excluding aircraft or ships) where Ecovet is held
(or reasonably likely to be held on occasion) in quantities greater than 10 000
L.
The emergency response plan must describe all of the likely emergencies that
may arise from the breach or failure of controls. The type of information that
is required to be included in the plan is specified in Regulations 29 to 30.
Requirements relating to the availability of equipment, materials and people
are provided in Regulation 31, requirements regarding the availability of the
plan are provided in Regulation 32 and requirements for testing the plan are
described in Regulation 33.
Level 3 emergency management requirements – secondary containment
These Regulations relate to the requirement for a secondary containment
system to be installed at any fixed location where Ecovet is held in quantities
equal to or greater than 10 000L.
Regulation 37 prescribes requirements for places where Ecovet is held above
ground in containers each holding up to 60L or less. Regulation 38
prescribes requirements for places where hazardous substances are held
above ground in containers each holding between 60L and 450L. Regulation
39 prescribes requirements for places where hazardous substances are held
above ground in containers each holding more than 450L. Regulation 40
prescribes requirements for places where hazardous substances are held
underground. Regulation 41 prescribes requirements for secondary
containment systems that contain substances of specific hazard
classifications.
Level 3 emergency management requirements – signage
This control relates to the provision of emergency management information
on signage at places where Ecovet is held at quantities equal to or greater
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Control
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Regulation8
Explanation9
than 1 000 L.
The signage must advise of the action to be taken in an emergency and must
meet the requirements for comprehensibility and clarity as defined in
Regulations 34 and 35 of the Identification Regulations.
Controls under section 77A
This substance shall only be used as a veterinary medicine.
The controls relating to stationary container systems, as set out in Schedule 8 of the Hazardous Substances
(Dangerous Goods and Scheduled Toxic Substances) Transfer Notice (New Zealand Gazette Issue No 35, 26
March 2004, as amended by Issue No. 128, 1 October 2004, shall apply to this substance, notwithstanding
clause 1(1) of that schedule.
Clause 100 shall apply to this substance, as if subclause (1) were omitted and the following substituted:
“(1) In this Part, existing stationary container system means a stationary container system to which this
Schedule applies that, immediately before 1 July 2005,—
(a) was being used to contain a substance described in Schedule 1 of the Hazardous Substances
(Veterinary Medicines) Transfer Notice 2005; or
(b) was designed to be used to contain a substance described in that Table, and construction of the
stationary container system to that design had commenced.”
The controls relating to adverse effects of unintended ignition of class 2 and class 3.1 hazardous substances,
set out in Schedule 10 of the New Zealand Gazette Notice of Thursday, 25 March 2004, Issue Number 35, as
amended by the New Zealand Gazette Notice of Friday, 1 October 2004, Issue Number 128, shall apply, as
applicable, notwithstanding clause 1 of the schedule.
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Control Codes and Explanations for Uptite
Control
Code10
Regulation11
Explanation12
Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 -Toxic Property Controls
T4
7
Requirements for equipment used to handle hazardous substances
Any equipment used Uptite must retain and/or dispense the substance in the
manner intended, i.e. without leakage, and must be accompanied by
sufficient information so that this can be achieved.
T5
8
Requirements for protective clothing and equipment
Protective clothing/equipment must be employed when Uptite is being
handled. The clothing/equipment must be designed, constructed and operated
to ensure that the person does not come into contact with the substance and is
not directly exposed to a concentration of the substances that is greater than
the WES for that substance.
The person in charge must ensure that people using the protective
clothing/equipment have access to sufficient information specifying how the
clothing/equipment may be used, and the requirements for maintaining the
clothing/equipment.
Hazardous Substances (Identification) Regulations 2001
The Identification Regulations prescribe requirements with regard to
identification of Uptite in terms of:
 information that must be “immediately available” with the substance
(priority and secondary identifiers). This information is generally
provided by way of the product label
 documentation that must be available in the workplace, generally
provided by way of MSDS
 signage at a place where there is a large quantity of the substance.
I1
6, 7, 32-35, 36 General identification requirements
(1)-(7)
These controls relate to the duties of suppliers and persons in charge of
Uptite with respect to identification (essentially labelling) (Regulations 6 and
7), accessibility of the required information (Regulations 32 and 33) and
presentation of the required information with respect to comprehensibility,
clarity and durability (Regulations 34, 35, 36(1)-(7))
Regulation 6 – Identification duties of suppliers
Suppliers of Uptite must ensure it is labelled with all relevant priority
identifier information (as required by Regulations 8-17) and secondary
identifier information (as required by Regulations 18-30) before supplying it
to any other person. This includes ensuring that the priority identifier
information is available to any person handling the substance within two
seconds (Regulation 32), and the secondary identifier information available
within 10 seconds (Regulation 33).
Suppliers must also ensure that no information is supplied with the substance
(or its packaging) that suggests it belongs to a class or subclass that it does
not in fact belong to.
10
Note: The numbering system used in this column relates to the coding system used in the ERMA New Zealand Controls Matrix. This links the
hazard classification categories to the regulatory controls triggered by each category. It is available from the ERMA New Zealand website
www.ermanz.govt.nz/resources and is also contained in the ERMA New Zealand User Guide to the HSNO Control Regulations.
11
These Regulations form the controls applicable to this substance. Refer to the cited Regulations for the formal specification, and for definitions
and exemptions. The accompanying explanation is intended for guidance only.
12
These explanations are for guidance only. Refer to the cited Regulations for the formal specification, and for definitions and exemptions.
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Control
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Regulation11
Explanation12
Regulation 7 – Identification duties of persons in charge
Persons in charge of Uptite must ensure it is labelled with all relevant priority
identifier information (as required by Regulations 8 to 17) and secondary
identifier information (as required by Regulations 18 to 30) before supplying
it to any other person. This includes ensuring that the priority identifier
information is available to any person handling the substance within two
seconds (Regulation 32), and the secondary identifier information available
within 10 seconds (Regulation 33).
Persons in charge must also ensure that no information is supplied with the
substance (or its packaging) that suggests it belongs to a class or subclass that
it does not in fact belong to.
Regulations 32 and 33 – Accessibility of information
All priority identifier Information (as required by Regulations 8 to 17) must
be available within two seconds, eg. on the label
All secondary identifier Information (as required by Regulations 18 to 30)
must be available within 10 seconds, eg. on the label.
I9
18
I16
25
Regulations 34, 35, 36(1)-(7) – Comprehensibility, Clarity and Durability of
information
All required priority and secondary identifiers must be presented in a way
that meets the performance standards in these Regulations. In summary:
 any information provided (either written and oral) must be readily
understandable and in English
 any information provided in written or pictorial form must be able to be
easily read or perceived by a person with average eyesight under normal
lighting conditions
 any information provided in an audible form must be able to be easily
heard by a person with average hearing
 any information provided must be in a durable format i.e. the information
requirements with respect to clarity must be able to be met throughout
the lifetime of the (packaged) substance under the normal conditions of
storage, handling and use.
Secondary identifiers for all hazardous substances
This control relates to detail required for Uptite on the product label. This
information must be accessible within 10 seconds (Regulation 33) and could
be provided on secondary panels on the product label. The following
information is required:
 an indication (which may include its common name, chemical name, or
registered trade name) that unequivocally identifies it, and
 enough information to enable its New Zealand importer, supplier, or
manufacturer to be contacted, either in person or by telephone, and
 in the case of a substance which, when in a closed container, is likely to
become more hazardous over time or develop additional hazardous
properties, or become a hazardous substance of a different class or
subclass, a description of each likely change and the date by which it is
likely to occur.
Secondary identifiers for toxic substances
This control relates to the additional label detail required for Uptite. This
information must be accessible within 10 seconds (Regulation 33) and could
be provided on secondary panels on the product label. The following
information must be provided:
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Control
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Regulation11
I17
26
I18
I19
27
29-31
Explanation12
 an indication of its general type and degree of toxic hazard (eg. suspected
human reproductive or developmental toxicant)
 an indication of the circumstances in which it may harm human beings
 an indication of the kinds of harm it may cause to human beings, and the
likely extent of each kind of harm
 an indication of the steps to be taken to prevent harm to human beings
 the name and concentration of Component C (6.8B)
Use of Generic Names
This control provides the option of using a generic name to identify specific
ingredients (or groups of ingredients) where such ingredients are required to
be listed on the product label as specified by Regulations 19(f) and 25(e) and
(f).
(Regulations 19(f) and 25(e) and (f) specify a requirement to list on the
product label, the name and concentration of Component C)
Use of Concentration Ranges
This control provides the option of providing concentration ranges for those
ingredients whose concentrations are required to be stated on the product
label as specified by Regulations 19(f) and 25(e) and (f).
(Regulations 19(f) and 25(e) and (f) specify a requirement to list on the
product label, the name and concentration of Component C)
Alternative information in certain cases
Regulation 29 – Substances in fixed bulk containers or bulk transport
containers
This Regulation relates to alternative ways of presenting the priority and
secondary identifier information required by Regulations 8 to 25 when
substances are contained in fixed bulk containers or bulk transport
containers.
Regulation 29(1) specifies that for fixed bulk containers, it is sufficient
compliance if there is available at all times to people near the container,
information that identifies the type and general degree of hazard of the
substance.
Regulation 29(2) specifies that for bulk transport containers, it is sufficient
compliance if the substance is labelled or marked in compliance with the
requirements of the Land Transport Rule 45001, Civil Aviation Act 1990 or
Maritime Transport Act 1994.
Regulation 30 – Substances in multiple packaging
This Regulation relates to situations when Uptite is in multiple packaging
and the outer packaging obscures some or all of the required substance
information. In such cases, the outer packaging must:
 be clearly labelled with all relevant priority identifier information i.e. the
hazardous properties of the substance must be identified, or
 be labelled or marked in compliance with either the Land Transport Rule
45001, Civil Aviation Act 1990 or the Maritime Safety Act 1994 as
relevant, or
 in the case of an ecotoxic substance, it must bear the EU pictogram
“Dangerous to the Environment” (‘dead fish and tree’ on orange
background), or
 bear the relevant class or subclass label assigned by the UN Model
Regulations.
ERMA New Zealand Decision: Application HSR05059
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Control
Code10
I21
Regulation11
37-39, 47-50
Explanation12
Regulation 31 – Alternative information when substances are imported
This Regulation relates to alternative information requirements for hazardous
substances that are imported into New Zealand in a closed package or in a
freight container and will be transported to their destination without being
removed from that package or container. In these situations, it is sufficient
compliance with HSNO if the package or container is labelled or marked in
compliance with the requirements of the Land Transport Rule 45001.
Documentation required in places of work
These controls relate to the duties of suppliers and persons in charge of
places of work with respect to provision of documentation (essentially
Material Safety Data Sheets) (Regulations 37, 38 and 50); the general content
requirements of the documentation (Regulation 39 and 47); the accessibility
and presentation of the required documentation with respect to
comprehensibility and clarity (Regulation 48).
These controls are triggered when Uptite is held in the workplace in
quantities equal to or greater than 3.0 kg.
Regulation 37 – Documentation duties of suppliers
A supplier must provide documentation containing all relevant information
required by Regulations 39 to 48 when selling or supplying to another person
a quantity of Uptite equal to or greater than 3.0 kg, if the substance is to be
used in a place of work and the supplier has not previously provided the
documentation to that person.
Regulation 38 – Documentation duties of persons in charge of places of work
The person in charge of any place of work where Uptite is present in
quantities equal to or greater than those specified in Regulation 38 (and with
reference to Schedule 2 of the Identification Regulations), must ensure that
every person handling the substance has access to the documentation
required for each hazardous substance concerned. The person in charge must
also ensure that the documentation does not contain any information that
suggests that the substance belongs to a class or subclass it does not in fact
belong to.
Regulation 39 – General content requirements for documentation
The documentation provided with Uptite must include the following
information:
 the unequivocal identity of the substance (eg. the CAS number, chemical
name, common name, UN number, registered trade name(s))
 a description of the physical state, colour and odour of the substance
 if the substance’s physical state may alter over the expected range of
workplace temperatures, the documentation must include a description of
the temperatures at which the changes in physical state may occur and
the nature of those changes.
 in the case of a substance that, when in a closed container, is likely to
become more hazardous over time or develop additional hazardous
properties, or become a hazardous substance of a different class, the
documentation must include a description of each likely change and the
date by which it is likely to occur
 contact details for the New Zealand supplier/manufacturer/importer
 all emergency management and disposal information required for the
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Control
Code10
Regulation11
Explanation12
substance
 the date on which the documentation was prepared
 the name, concentration and CAS number of Component C.
Regulation 47 – Information not included in approval
This Regulation relates to the provision of specific documentation
information (eg. as provided on an MSDS). If information required by
Regulations 39 to 46 was not included in the information used for the
approval of the substance by the Authority, it is sufficient compliance with
those Regulations if reference is made to that information requirement along
with a comment indicating that such information is not applicable to that
substance.
Regulation 48 – Location and presentation requirements for documentation
All required documentation must be available to a person handling the
substance in a place of work within 10 minutes. The documentation must be
readily understandable by any fully-trained worker required to have access to
it and must be easily read, under normal lighting conditions, at a distance of
not less than 0.3m.
Regulation 49 – Documentation requirements for vehicles
This Regulation provides for the option of complying with documentation
requirements as specified in the various Land, Sea and Air transport rules
when the substance is being transported.
Regulation 50 – Documentation to be supplied on request
Notwithstanding Regulation 37 above, a supplier must provide the required
documentation to any person in charge of a place of work (where a hazardous
substance is present) if asked to do so by that person.
I28
46
Specific documentation requirements for toxic substances
The documentation provided with Uptite must include the following
information:
 its general degree and type of toxic hazard
 a full description of the circumstances in which it may harm human
beings
 the kinds of harm it may cause to human beings
 a full description of the steps to be taken to prevent harm to human
beings
 a summary of the available acute and chronic (toxic) data used to define
the (toxic) subclass or subclasses in which it is classified
 the symptoms or signs of injury or ill health associated with each likely
route of exposure
 the dose, concentration, or conditions of exposure likely to cause injury
or ill health.
Hazardous Substances (Packaging) Regulations 2001
P1
5, 6, 7 (1), 8
General packaging requirements
These controls relate to the ability of the packaging to retain its contents,
allowable packaging markings with respect to design approvals, factors
affecting choice of suitable packaging, and compatibility of the substance
with any previous contents of the packaging.
Regulation 5 – Ability to retain contents
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Control
Code10
Regulation11
Explanation12
Packaging for Uptite must ensure that, when the package is closed, there is
no visible release of the substance, and that it maintains its ability to retain its
contents in temperatures from –10oC to +50oC. The packaging must also
maintain its ability to retain its remaining contents if part of the contents is
removed from the package and the packaging is then re-closed. The
packaging in direct contact with the substance must not be significantly
affected or weakened by contact with the substance such that the foregoing
requirements cannot be met.
Regulation 6 – Packaging markings
Packages containing Uptite must not be marked in accordance with the UN
Model Regulations unless:
 the markings comply with the relevant provisions of that document, and
 the packaging complies with the tests set out in Schedule 1, 2 or 3
(Packaging Regulations) respectively, and
 the design of the packaging has been test certified as complying with
those tests.
Regulation 7(1) – Requirements when packing hazardous substance
 When packing Uptite, account must be taken of its physical state and
properties, and packaging must be selected that complies with the
requirements of Regulation 5, and Regulations 9 to 21.
Regulation 8 – Compatibility
Uptite must not be packed in packaging that has been previously packed with
substances with which it is incompatible unless all traces of the previous
substance have been removed.
Regulation 9A and 9B – Large Packaging
Large packaging may be used to contain Uptite in New Zealand if it has been
constructed, marked and tested as a large package as provided in Chapter 6.6
of the 13th revised edition of the UNRTDG, 2003.
“Large Packaging” does not include:
 a tank, tank wagon or transportable container (as defined in the
Hazardous Substances (Tank Wagons and Transportable Containers)
Regulations 2004, or
 a stationary container system, a stationary tank or a tank (as defined in
the Hazardous substances (Dangerous Goods and Scheduled Toxic
Substances) Transfer Notice 2004.
P3
9
PS4
Schedule 4
Packaging requirements for substances packed in limited quantities
When Uptite is packaged in quantities of 400 kg or less, there is provision
for it to be packaged to a lesser performance standard than normally required
(as specified in Schedule 4 of the Packaging Regulations).
This schedule describes the minimum packaging requirements that must be
complied with for this substance.
Hazardous Substances (Disposal) Regulations 2001
D4
8
Disposal requirements for toxic and corrosive substances
Uptite must be disposed of by:
ERMA New Zealand Decision: Application HSR05059
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Control
Code10
Regulation11
D6
10
D7
11, 12
D8
13, 14
Explanation12
 treating the substance so that it is no longer a hazardous substance,
including depositing the substance in a landfill, incinerator or sewage
facility. However, this does not include dilution of the substance with
any other substance prior to discharge to the environment; or
 exporting the substance from New Zealand as a hazardous waste.
Disposal requirements for packages
This control gives the disposal requirements for packages that contained
Uptite and are no longer to be used for that purpose. Such packages must be
either decontaminated/treated or rendered incapable of containing any
substance (hazardous or otherwise) and then disposed of in a manner that is
consistent with the disposal requirements for the substance. In addition, the
manner of disposal must take into account the material that the package is
manufactured from.
Disposal information requirements
These controls relate to the provision of information concerning disposal
(essentially on the label) that must be provided when selling or supplying a
quantity of Uptite that exceeds 0.1 kg.
Information must be provided on appropriate methods of disposal and
information may be supplied warning of methods of disposal that should be
avoided, i.e. that would not comply with the Disposal Regulations. Such
information must be accessible to a person handling the substance within 10
seconds and must comply with the requirements for comprehensibility,
clarity and durability as described in Regulations 34-36 of the Identification
Regulations (code I1).
Disposal documentation requirements
These controls relate to the provision of documentation concerning disposal
(essentially in a MSDS) that must be provided when selling or supplying a
quantity of Uptite that exceeds 3.0 kg.
The documentation must describe one or more methods of disposal (that
comply with the Disposal Regulations) and describe any precautions that
must be taken. Such documentation must be accessible to a person handling
the substance at a place of work within 10 minutes and must comply with
the requirements for comprehensibility and clarity as described in
Regulations 48(2), (3) and (4) of the Identification Regulations (code I21).
Hazardous Substances (Emergency Management) Regulations 2001
EM8
12-16, 18-20
Level 2 emergency management information requirements
These controls relate to the duties of suppliers and persons in charge of
places of work with respect to the provision of emergency management
documentation (essentially Material Safety Data Sheets). This
documentation must be provided where Uptite is sold or supplied, or held in
a workplace, in quantities equal to or greater than 3.0 kg.
Regulations 12 and 13 describe the duties of suppliers, regulation 14
describes the duties of persons in charge of places of work, regulation 15
provides for the option of complying with documentation requirements of the
transport rules when the substance is being transported, and regulation 16
specifies requirements for general contents of the documentation.
Regulation 18 prescribes location and presentation requirements for the
documentation, i.e. it must be available within 10 minutes, be readily
understandable, comprehensible and clear. These requirements correspond
ERMA New Zealand Decision: Application HSR05059
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Control
Code10
Regulation11
Explanation12
with those relating to documentation required by the Identification
regulations (code I21).
Controls under section 77A
This substance shall only be used as a veterinary medicine.
ERMA New Zealand Decision: Application HSR05059
Page 52 of 62
Default Control Codes and Explanations for Patten’s Milkeeze
Control
Code13
Regulation14
Explanation15
Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 -Toxic Property Controls
T2
29, 30
Controlling exposure in places of work
A workplace exposure standard (WES) is designed to protect persons in the
workplace from the adverse effects of toxic substances. A WES is an
airborne concentration of a substance (expressed as mg substance/m3 of air or
ppm in air), which must not be exceeded in a workplace and applies to every
place of work.
T4 and E6
7
T5
8
The following WES values apply to Patten's Milkeeze:
Component C TWA = 5 mg/m3
STEL = 10 mg/m3
Requirements for equipment used to handle hazardous substances
Any equipment used Patten’s Milkeeze must retain and/or dispense the
substance in the manner intended, i.e. without leakage, and must be
accompanied by sufficient information so that this can be achieved.
Requirements for protective clothing and equipment
Protective clothing/equipment must be employed when Patten’s Milkeeze is
being handled. The clothing/equipment must be designed, constructed and
operated to ensure that the person does not come into contact with the
substance and is not directly exposed to a concentration of the substances
that is greater than the WES for that substance.
The person in charge must ensure that people using the protective
clothing/equipment have access to sufficient information specifying how the
clothing/equipment may be used, and the requirements for maintaining the
clothing/equipment.
T7
10
Restrictions on the carriage of hazardous substances on passenger
service vehicles
In order to limit the potential for public exposure to Patten’s Milkeeze the
maximum quantity per package of Patten’s Milkeeze permitted to be carried
on passenger service vehicles is 1 kg.
Hazardous Substances (Identification) Regulations 2001
The Identification Regulations prescribe requirements with regard to
identification of Patten’s Milkeeze in terms of:
 information that must be “immediately available” with the substance
(priority and secondary identifiers). This information is generally
provided by way of the product label
 documentation that must be available in the workplace, generally
provided by way of MSDS
 signage at a place where there is a large quantity of the substance.
I1
6, 7, 32-35, 36 General identification requirements
(1)-(7)
These controls relate to the duties of suppliers and persons in charge of
Patten’s Milkeeze with respect to identification (essentially labelling)
(Regulations 6 and 7), accessibility of the required information (Regulations
13
Note: The numbering system used in this column relates to the coding system used in the ERMA New Zealand Controls Matrix. This links the
hazard classification categories to the regulatory controls triggered by each category. It is available from the ERMA New Zealand website
www.ermanz.govt.nz/resources and is also contained in the ERMA New Zealand User Guide to the HSNO Control Regulations.
14
These Regulations form the controls applicable to this substance. Refer to the cited Regulations for the formal specification, and for definitions
and exemptions. The accompanying explanation is intended for guidance only.
15
These explanations are for guidance only. Refer to the cited Regulations for the formal specification, and for definitions and exemptions.
ERMA New Zealand Decision: Application HSR05059
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Control
Code13
Regulation14
Explanation15
32 and 33) and presentation of the required information with respect to
comprehensibility, clarity and durability (Regulations 34, 35, 36(1)-(7))
Regulation 6 – Identification duties of suppliers
Suppliers of Patten’s Milkeeze must ensure it is labelled with all relevant
priority identifier information (as required by Regulations 8-17) and
secondary identifier information (as required by Regulations 18-30) before
supplying it to any other person. This includes ensuring that the priority
identifier information is available to any person handling the substance
within two seconds (Regulation 32), and the secondary identifier information
available within 10 seconds (Regulation 33).
Suppliers must also ensure that no information is supplied with the substance
(or its packaging) that suggests it belongs to a class or subclass that it does
not in fact belong to.
Regulation 7 – Identification duties of persons in charge
Persons in charge of Patten’s Milkeeze must ensure it is labelled with all
relevant priority identifier information (as required by Regulations 8 to 17)
and secondary identifier information (as required by Regulations 18 to 30)
before supplying it to any other person. This includes ensuring that the
priority identifier information is available to any person handling the
substance within two seconds (Regulation 32), and the secondary identifier
information available within 10 seconds (Regulation 33).
Persons in charge must also ensure that no information is supplied with the
substance (or its packaging) that suggests it belongs to a class or subclass that
it does not in fact belong to.
Regulations 32 and 33 – Accessibility of information
All priority identifier Information (as required by Regulations 8 to 17) must
be available within two seconds, eg. on the label
All secondary identifier Information (as required by Regulations 18 to 30)
must be available within 10 seconds, eg. on the label.
Regulations 34, 35, 36(1)-(7) – Comprehensibility, Clarity and Durability of
information
All required priority and secondary identifiers must be presented in a way
that meets the performance standards in these Regulations. In summary:
 any information provided (either written and oral) must be readily
understandable and in English
 any information provided in written or pictorial form must be able to be
easily read or perceived by a person with average eyesight under normal
lighting conditions
 any information provided in an audible form must be able to be easily
heard by a person with average hearing
 any information provided must be in a durable format i.e. the information
requirements with respect to clarity must be able to be met throughout
the lifetime of the (packaged) substance under the normal conditions of
storage, handling and use.
I9
18
Secondary identifiers for all hazardous substances
This control relates to detail required for Patten’s Milkeeze on the product
label. This information must be accessible within 10 seconds (Regulation 33)
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Control
Code13
Regulation14
I11
20
I16
25
I17
26
I18
I19
27
29-31
Explanation15
and could be provided on secondary panels on the product label. The
following information is required:
 an indication (which may include its common name, chemical name, or
registered trade name) that unequivocally identifies it, and
 enough information to enable its New Zealand importer, supplier, or
manufacturer to be contacted, either in person or by telephone, and
 in the case of a substance which, when in a closed container, is likely to
become more hazardous over time or develop additional hazardous
properties, or become a hazardous substance of a different class or
subclass, a description of each likely change and the date by which it is
likely to occur.
Secondary identifiers for ecotoxic substances
This control relates to the additional label detail required for Patten’s
Milkeeze. This information must be accessible within 10 seconds
(Regulation 33) and could be provided on secondary panels on the product
label. The following information must be provided:
 an indication of the circumstances in which it may harm living organisms
 an indication of the kind and extent of the harm it is likely to cause to
living organisms
 an indication of the steps to be taken to prevent harm to living organisms
Secondary identifiers for toxic substances
This control relates to the additional label detail required for Patten’s
Milkeeze. This information must be accessible within 10 seconds
(Regulation 33) and could be provided on secondary panels on the product
label. The following information must be provided:
 an indication of its general type and degree of toxic hazard (eg. skin
sensitiser)
 an indication of the circumstances in which it may harm human beings
 an indication of the kinds of harm it may cause to human beings, and the
likely extent of each kind of harm
 an indication of the steps to be taken to prevent harm to human beings
 the name and concentration of Component A
Use of Generic Names
This control provides the option of using a generic name to identify specific
ingredients (or groups of ingredients) where such ingredients are required to
be listed on the product label as specified by Regulations 19(f) and 25(e) and
(f).
(Regulations 19(f) and 25(e) and (f) specify a requirement to list on the
product label, the name and concentration of Component A)
Use of Concentration Ranges
This control provides the option of providing concentration ranges for those
ingredients whose concentrations are required to be stated on the product
label as specified by Regulations 19(f) and 25(e) and (f).
(Regulations 19(f) and 25(e) and (f) specify a requirement to list on the
product label, the name and concentration of Component A)
Alternative information in certain cases
Regulation 29 – Substances in fixed bulk containers or bulk transport
containers
This Regulation relates to alternative ways of presenting the priority and
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Control
Code13
Regulation14
Explanation15
secondary identifier information required by Regulations 8 to 25 when
substances are contained in fixed bulk containers or bulk transport
containers.
Regulation 29(1) specifies that for fixed bulk containers, it is sufficient
compliance if there is available at all times to people near the container,
information that identifies the type and general degree of hazard of the
substance.
Regulation 29(2) specifies that for bulk transport containers, it is sufficient
compliance if the substance is labelled or marked in compliance with the
requirements of the Land Transport Rule 45001, Civil Aviation Act 1990 or
Maritime Transport Act 1994.
Regulation 30 – Substances in multiple packaging
This Regulation relates to situations when Patten’s Milkeeze is in multiple
packaging and the outer packaging obscures some or all of the required
substance information. In such cases, the outer packaging must:
 be clearly labelled with all relevant priority identifier information i.e. the
hazardous properties of the substance must be identified, or
 be labelled or marked in compliance with either the Land Transport Rule
45001, Civil Aviation Act 1990 or the Maritime Safety Act 1994 as
relevant, or
 in the case of an ecotoxic substance, it must bear the EU pictogram
“Dangerous to the Environment” (‘dead fish and tree’ on orange
background), or
 bear the relevant class or subclass label assigned by the UN Model
Regulations.
I21
37-39, 47-50
Regulation 31 – Alternative information when substances are imported
This Regulation relates to alternative information requirements for hazardous
substances that are imported into New Zealand in a closed package or in a
freight container and will be transported to their destination without being
removed from that package or container. In these situations, it is sufficient
compliance with HSNO if the package or container is labelled or marked in
compliance with the requirements of the Land Transport Rule 45001.
Documentation required in places of work
These controls relate to the duties of suppliers and persons in charge of
places of work with respect to provision of documentation (essentially
Material Safety Data Sheets) (Regulations 37, 38 and 50); the general content
requirements of the documentation (Regulation 39 and 47); the accessibility
and presentation of the required documentation with respect to
comprehensibility and clarity (Regulation 48).
These controls are triggered when Patten’s Milkeeze is held in the workplace
in quantities equal to or greater than 3.0 kg.
Regulation 37 – Documentation duties of suppliers
A supplier must provide documentation containing all relevant information
required by Regulations 39 to 48 when selling or supplying to another person
a quantity of Patten’s Milkeeze equal to or greater than 3.0 kg, if the
substance is to be used in a place of work and the supplier has not previously
provided the documentation to that person.
Regulation 38 – Documentation duties of persons in charge of places of work
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Control
Code13
Regulation14
Explanation15
The person in charge of any place of work where Patten’s Milkeeze is
present in quantities equal to or greater than those specified in Regulation 38
(and with reference to Schedule 2 of the Identification Regulations), must
ensure that every person handling the substance has access to the
documentation required for each hazardous substance concerned. The person
in charge must also ensure that the documentation does not contain any
information that suggests that the substance belongs to a class or subclass it
does not in fact belong to.
Regulation 39 – General content requirements for documentation
The documentation provided with Patten’s Milkeeze must include the
following information:
 the unequivocal identity of the substance (eg. the CAS number, chemical
name, common name, UN number, registered trade name(s))
 a description of the physical state, colour and odour of the substance
 if the substance’s physical state may alter over the expected range of
workplace temperatures, the documentation must include a description of
the temperatures at which the changes in physical state may occur and
the nature of those changes.
 in the case of a substance that, when in a closed container, is likely to
become more hazardous over time or develop additional hazardous
properties, or become a hazardous substance of a different class, the
documentation must include a description of each likely change and the
date by which it is likely to occur
 contact details for the New Zealand supplier/manufacturer/importer
 all emergency management and disposal information required for the
substance
 the date on which the documentation was prepared
 the name, concentration and CAS number of Component A
Regulation 47 – Information not included in approval
This Regulation relates to the provision of specific documentation
information (eg. as provided on an MSDS). If information required by
Regulations 39 to 46 was not included in the information used for the
approval of the substance by the Authority, it is sufficient compliance with
those Regulations if reference is made to that information requirement along
with a comment indicating that such information is not applicable to that
substance.
Regulation 48 – Location and presentation requirements for documentation
All required documentation must be available to a person handling the
substance in a place of work within 10 minutes. The documentation must be
readily understandable by any fully-trained worker required to have access to
it and must be easily read, under normal lighting conditions, at a distance of
not less than 0.3m.
Regulation 49 – Documentation requirements for vehicles
This Regulation provides for the option of complying with documentation
requirements as specified in the various Land, Sea and Air transport rules
when the substance is being transported.
Regulation 50 – Documentation to be supplied on request
Notwithstanding Regulation 37 above, a supplier must provide the required
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Control
Code13
Regulation14
I28
46
I29
51-52
Explanation15
documentation to any person in charge of a place of work (where a hazardous
substance is present) if asked to do so by that person.
Specific documentation requirements for toxic substances
The documentation provided with Patten’s Milkeeze must include the
following information:
 its general degree and type of toxic hazard
 a full description of the circumstances in which it may harm human
beings
 the kinds of harm it may cause to human beings
 a full description of the steps to be taken to prevent harm to human
beings
 a summary of the available acute and chronic (toxic) data used to define
the (toxic) subclass or subclasses in which it is classified
 the symptoms or signs of injury or ill health associated with each likely
route of exposure
 the dose, concentration, or conditions of exposure likely to cause injury
or ill health
 any WESs set by the Authority.
Duties of persons in charge of places with respect to signage
These controls specify the requirements for signage, in terms of content,
presentation and positioning at places where Patten’s Milkeeze is held in
quantities exceeding 10 000 kg.
Signs are required:
 at every entrance to the building and/or location (vehicular and
pedestrian) where hazardous substances are present
 at each entrance to rooms or compartments where hazardous substances
are present
 immediately adjacent to the area where hazardous substances are located
in an outdoor area.
The information provided in the signage needs to be understandable over a
distance of 10 metres and be sufficient to:
 advise that the location contains hazardous substances
 describe the general type of hazard of each substance (e.g. flammable)
 where the signage is immediately adjacent to the hazardous substance
storage areas, describe the precautions needed to safely manage the
substance (eg. a 'No Smoking' warning near flammable substances).
The following variation to control I29 applies to Patten’s Milkeeze:
The following words:
“at every vehicular and pedestrian access to the building, and every
vehicular and pedestrian access to land where the building is located”
in subclause (1) of Regulation 52 are omitted and the following
substituted:
", in the case of a building where milking animals are milked, at the
primary human entrance to the building, or in all other cases, at every
vehicular and pedestrian access to the building"
Where Patten’s Milkeeze is located in a building where milking animals
are milked, subclause (2) of regulation 52 does not apply.
Hazardous Substances (Packaging) Regulations 2001
ERMA New Zealand Decision: Application HSR05059
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Control
Code13
P1
Regulation14
5, 6, 7 (1), 8
Explanation15
General packaging requirements
These controls relate to the ability of the packaging to retain its contents,
allowable packaging markings with respect to design approvals, factors
affecting choice of suitable packaging, and compatibility of the substance
with any previous contents of the packaging.
Regulation 5 – Ability to retain contents
Packaging for Patten’s Milkeeze must ensure that, when the package is
closed, there is no visible release of the substance, and that it maintains its
ability to retain its contents in temperatures from –10oC to +50oC. The
packaging must also maintain its ability to retain its remaining contents if
part of the contents is removed from the package and the packaging is then
re-closed. The packaging in direct contact with the substance must not be
significantly affected or weakened by contact with the substance such that
the foregoing requirements cannot be met.
Regulation 6 – Packaging markings
Packages containing Patten’s Milkeeze must not be marked in accordance
with the UN Model Regulations unless:
 the markings comply with the relevant provisions of that document, and
 the packaging complies with the tests set out in Schedule 1, 2 or 3
(Packaging Regulations) respectively, and
 the design of the packaging has been test certified as complying with
those tests.
Regulation 7(1) – Requirements when packing hazardous substance
 When packing Patten’s Milkeeze, account must be taken of its physical
state and properties, and packaging must be selected that complies with
the requirements of Regulation 5, and Regulations 9 to 21.
Regulation 8 – Compatibility
Patten’s Milkeeze must not be packed in packaging that has been previously
packed with substances with which it is incompatible unless all traces of the
previous substance have been removed.
Regulation 9A and 9B – Large Packaging
Large packaging may be used to contain Patten’s Milkeeze in New Zealand
if it has been constructed, marked and tested as a large package as provided
in Chapter 6.6 of the 13th revised edition of the UNRTDG, 2003.
P3
9
PS4
Schedule 4
“Large Packaging” does not include:
 a tank, tank wagon or transportable container (as defined in the
Hazardous Substances (Tank Wagons and Transportable Containers)
Regulations 2004, or
 a stationary container system, a stationary tank or a tank (as defined in
the Hazardous substances (Dangerous Goods and Scheduled Toxic
Substances) Transfer Notice 2004.
Packaging requirements for substances packed in limited quantities
When Patten’s Milkeeze is packaged in quantities of 400 kg or less, there is
provision for it to be packaged to a lesser performance standard than
normally required (as specified in Schedule 4 of the Packaging Regulations).
This schedule describes the minimum packaging requirements that must be
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Control
Code13
Regulation14
Explanation15
complied with for this substance.
Hazardous Substances (Disposal) Regulations 2001
D4 and
8 and 9
Disposal requirements for Patten’s Milkeeze
D5
Patten’s Milkeeze must be disposed of by:
 treating the substance so that it is no longer a hazardous substance,
including depositing the substance in a landfill, incinerator or sewage
facility. However, this does not include dilution of the substance with
any other substance prior to discharge to the environment; or
 exporting the substance from New Zealand as a hazardous waste.
D6
10
Disposal requirements for packages
This control gives the disposal requirements for packages that contained
Patten’s Milkeeze and are no longer to be used for that purpose. Such
packages must be either decontaminated/treated or rendered incapable of
containing any substance (hazardous or otherwise) and then disposed of in a
manner that is consistent with the disposal requirements for the substance. In
addition, the manner of disposal must take into account the material that the
package is manufactured from.
D7
11, 12
Disposal information requirements
These controls relate to the provision of information concerning disposal
(essentially on the label) that must be provided when selling or supplying a
quantity of Patten’s Milkeeze that exceeds 1.0 kg.
Information must be provided on appropriate methods of disposal and
information may be supplied warning of methods of disposal that should be
avoided, i.e. that would not comply with the Disposal Regulations. Such
information must be accessible to a person handling the substance within 10
seconds and must comply with the requirements for comprehensibility,
clarity and durability as described in Regulations 34-36 of the Identification
Regulations (code I1).
D8
13, 14
Disposal documentation requirements
These controls relate to the provision of documentation concerning disposal
(essentially in a MSDS) that must be provided when selling or supplying a
quantity of Patten’s Milkeeze that exceeds 3.0 kg.
The documentation must describe one or more methods of disposal (that
comply with the Disposal Regulations) and describe any precautions that
must be taken. Such documentation must be accessible to a person handling
the substance at a place of work within 10 minutes and must comply with
the requirements for comprehensibility and clarity as described in
Regulations 48(2), (3) and (4) of the Identification Regulations (code I21).
Hazardous Substances (Emergency Management) Regulations 2001
EM1
6, 7, 9-11
Level 1 emergency management information: General requirements
These controls relate to the provision of emergency management information
(essentially on the label) that must be provided with Patten’s Milkeeze when
present in quantities equal to or greater than 1.0 kg.
Regulation 6 describes the duties of suppliers, Regulation 7 describes the
duties of persons in charge of places, Regulation 9 describes the requirement
for the availability of the information (10 seconds) and Regulation 10 gives
the requirements relating to the presentation of the information with respect
to comprehensibility, clarity and durability. These requirements correspond
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Control
Code13
Regulation14
EM6
8(e)
EM7
8(f)
EM8
12-16, 18-20
Explanation15
with those relating to secondary identifiers required by the Identification
Regulations (code I1, Regulations 6, 7, 32–35, 36(1)-(7)).
Regulation 11 provides for the option of complying with the information
requirements of the transport rules when the substance is being transported.
Information requirements for toxic substances
The following information must be provided when Patten’s Milkeeze is
present in quantities equal to or greater than 1.0 kg:
 a description of the first aid to be given
 a 24-hour emergency service telephone number.
Information requirements for ecotoxic substances
The following information must be provided with ecotoxic substances when
present in quantities equal to or greater than 1.0 kg:
 a description of the parts of the environment likely to be immediately
affected by it:
 a description of its typical effects on those parts of the environment
 a statement of any immediate actions that may be taken to prevent the
substance from entering or affecting those parts of the environment.
Level 2 emergency management information requirements
These controls relate to the duties of suppliers and persons in charge of
places of work with respect to the provision of emergency management
documentation (essentially Material Safety Data Sheets). This
documentation must be provided where Patten’s Milkeeze is sold or supplied,
or held in a workplace, in quantities equal to or greater than 3.0 kg.
Regulations 12 and 13 describe the duties of suppliers, regulation 14
describes the duties of persons in charge of places of work, regulation 15
provides for the option of complying with documentation requirements of the
transport rules when the substance is being transported, and regulation 16
specifies requirements for general contents of the documentation.
EM11
EM12
25-34
35-41
Regulation 18 prescribes location and presentation requirements for the
documentation, i.e. it must be available within 10 minutes, be readily
understandable, comprehensible and clear. These requirements correspond
with those relating to documentation required by the Identification
regulations (code I21).
Level 3 emergency management requirements – emergency response
plans
These Regulations relate to the requirement for an emergency response plan
to be available at any place (excluding aircraft or ships) where Patten’s
Milkeeze is held (or reasonably likely to be held on occasion) in quantities
greater than 1 000 kg.
The emergency response plan must describe all of the likely emergencies that
may arise from the breach or failure of controls. The type of information that
is required to be included in the plan is specified in Regulations 29 to 30.
Requirements relating to the availability of equipment, materials and people
are provided in Regulation 31, requirements regarding the availability of the
plan are provided in Regulation 32 and requirements for testing the plan are
described in Regulation 33.
Level 3 emergency management requirements – secondary containment
These Regulations relate to the requirement for a secondary containment
system to be installed at any fixed location where Patten’s Milkeeze is held
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Control
Code13
EM13
Regulation14
42
Explanation15
in quantities equal to or greater than 1 000 kg.
Regulation 37 prescribes requirements for places where hazardous
substances are held above ground in containers each holding up to 60L or
less. Regulation 38 prescribes requirements for places where hazardous
substances are held above ground in containers each holding between 60L
and 450L. Regulation 39 prescribes requirements for places where
hazardous substances are held above ground in containers each holding more
than 450L. Regulation 40 prescribes requirements for places where
hazardous substances are held underground. Regulation 41 prescribes
requirements for secondary containment systems that contain substances of
specific hazard classifications, eg. there is a requirement to prevent
substances from coming into contact with incompatible materials, and a
requirement to exclude energy sources when class 1, 2, 3, 4 or 5 substances
are contained).
Level 3 emergency management requirements – signage
This control relates to the provision of emergency management information
on signage at places where Patten’s Milkeeze is held at quantities equal to or
greater than 10 000 kg.
The signage must advise of the action to be taken in an emergency and must
meet the requirements for comprehensibility and clarity as defined in
Regulations 34 and 35 of the Identification Regulations.
Controls under section 77A
This substance shall only be used as a veterinary medicine.
The controls relating to stationary container systems, as set out in Schedule 8 of the Hazardous Substances
(Dangerous Goods and Scheduled Toxic Substances) Transfer Notice (New Zealand Gazette Issue No 35, 26
March 2004, as amended by Issue No. 128, 1 October 2004, shall apply to this substance, notwithstanding
clause 1(1) of that schedule.
Clause 100 shall apply to this substance, as if subclause (1) were omitted and the following substituted:
“(1) In this Part, existing stationary container system means a stationary container system to which this
Schedule applies that, immediately before 1 July 2005,—
(a) was being used to contain a substance described in Schedule 1 of the Hazardous Substances
(Veterinary Medicines) Transfer Notice 2005; or
(b) was designed to be used to contain a substance described in that Table, and construction of the
stationary container system to that design had commenced.”
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