ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
Application Code
HSR07035
Application Type
To import or manufacture for release any hazardous
substance under Section 28 of the Hazardous Substances
and New Organisms Act 1996
Applicant
Nufarm New Zealand Limited
Date Application Received
19 March 2007
Submission Period
02 April 2007 to 17 May 2007
Considered by
A Committee of the Authority (“the Committee”)
Purpose of the Application
Flutriafol and Imazalil sulphate: to approve for importation
for the purpose of formulating into fungicidal products
(category A).
1 Summary of decision
1.1
The application to import flutriafol for release is approved with controls in
accordance with the relevant provisions of the Hazardous Substances and New
Organisms Act 1996 (“the Act”), the HSNO Regulations and the HSNO
(Methodology) Order 1998 (“the Methodology”).
1.2
The application to import imazalil sulphate for release is approved with controls
in accordance with the relevant provisions of the Act, the HSNO Regulations and
the Methodology.
1.3
The substances have been given the following unique identifiers for the ERMA
New Zealand Hazardous Substances Register:
Flutriafol
Imazalil sulphate
2 Legislative criteria for application
2.1
The application was lodged pursuant to section 28. The decision was determined in
accordance with section 29, taking into account matters to be considered in that
section and additional matters specified under Part II of the Act. Unless otherwise
stated, references to section numbers in this decision refer to sections of the 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 19 March 2007.
3.2
In accordance with sections 53(1) and 53A, and clauses 2(2)(b) and 7, public
notification was made on 02 April 2007.
3.3
Submissions closed on 17 May 2007.
3.4
Various Government departments, Crown Entities and interested parties, including
the New Zealand Food Safety Authority (Agricultural Compounds and Veterinary
Medicines (ACVM) Group), the Ministry of Health and the Department of Labour
Work Place Group, 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.
3.4.1
3.5
No comments or submissions were received.
The Ministry of Health, the Department of Labour, the New Zealand Food Safety
Authority (Agricultural Compounds and Veterinary Medicines (ACVM) Group),
and the applicant were given the opportunity to comment on the Agency’s
Evaluation and Review report (the E&R Report) and the controls proposed therein.
3.5.1
No responses were received.
3.6
No external experts were used in the consideration of this application (clause 17).
3.7
Two waivers were issued to extend the time taken to complete the E&R Report to
the Authority.
3.8
The following members of the Authority considered the application (section
19(2)(b)): Professor George Clark (chair), Dr. Max Suckling, Dr. Manuka Henare
and Ms Helen Atkins.
3.9
The information available to the Committee comprised:
 the application; and
 the E&R Report including confidential appendices.
4 Consideration
Purpose of the application
4.1
The purpose of the application is to gain approval to import two pesticidal active
ingredients, flutriafol and imazalil sulphate, into New Zealand so they may be used
in the formulation of pesticide products in New Zealand.
ERMA New Zealand Decision: Application HSR07035
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Sequence of the consideration
4.2
In accordance with clause 24, the approach to the consideration adopted by the
Committee was to:
 establish the hazard classifications for the substances and derive the default
controls that are prescribed under section 77 for each classification.
 identify potentially non-negligible risks, costs, and benefits.
 assess the potentially non-negligible risks and costs. Risks were assessed in
accordance with clause 12, and costs in accordance with clause 13. The
adequacy of the default controls, prescribed under section 77, was considered
alongside the assessment of risks and costs to determine whether those
controls should be varied and identify where additional controls need to be
applied, under section 77A, to mitigate any unacceptable risks.
 undertake a combined consideration of all the risks and costs and determine
whether the combined risks and costs are negligible or non-negligible.
 consider (a) whether any of the non-negligible risks could be reduced by
varying the controls in accordance with sections 77 or 77A, and (b) the costeffectiveness of the application of controls in accordance with clause 35 and
sections 77 and 77A.
 assess the benefits associated with this application in accordance with clauses 9,
11, 13 and 14 and section 6(e).
 taking into account the risk characteristics established under clause 33, evaluate
the risks, costs and benefits in accordance with clause 34 and section 29 and
determine whether the application should be approved or declined.
 confirm and set the controls.
Hazard classifications
4.3
The Agency has classified flutriafol as follows:
Hazardous Property
Acute oral toxicity
Acute inhalation toxicity
Eye irritancy
Reproductive/ Developmental toxicity
Target organ toxicity
Aquatic ecotoxicity
Terrestrial vertebrate ecotoxicity
4.4
Classification
6.1C
6.1D
6.4A
6.8B
6.9B
9.1B
9.3B
The Agency has classified imazalil sulphate as follows:
Hazardous Property
Acute oral toxicity
Acute inhalation toxicity
Eye corrosivity
Target organ toxicity
Aquatic ecotoxicity
Terrestrial vertebrate ecotoxicity
ERMA New Zealand Decision: Application HSR07035
Classification
6.1D
6.1D
8.3A
6.9B
9.1A
9.3B
Page 3 of 21
Default controls
4.5
In the E&R Report, the Agency assigned default controls for flutriafol and imazalil
sulphate based on their hazardous properties as set out in the HSNO Regulations.
The default controls were used as a reference for evaluation of the application in
the E&R Report. The default controls are listed in Section 8 of the E&R Report
and have not been reproduced here.
Identification of the potentially non-negligible risks, costs and benefits
of flutriafol and imazalil sulphate
Potentially non-negligible risks
4.6
Following a review of the qualitative risk assessment carried out by the Agency, the
Committee is satisfied that:
 the risks posed to human health by both substances potentially range from
negligible to low;
 the risks posed to the environment by flutriafol and imazalil sulphate are
negligible;
 there are no significant risks to Māori cultural wellbeing, society and the
community; the market economy, or to New Zealand’s international obligations;
 the use of the substances will not breach the principles of the Treaty of
Waitangi.
Potentially non-negligible costs
4.7
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”. Accordingly, the
costs were assessed in an integrated fashion together with the risks in the Agency’s
assessment.
Potentially non-negligible benefits
4.8
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.
4.9
The Committee notes that the following benefits have been put forward by the
applicant:

That approval will enable New Zealand manufacturers to produce products
utilising these substances.

Imports of products containing these substances will be reduced allowing profits
to be kept within the country and may result in lower cost products due to
reductions in transport costs.

The creation of additional work within the chemicals industry and potential
enhancement of employment opportunities in this sector.
ERMA New Zealand Decision: Application HSR07035
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Assessment of the potentially non-negligible risks and costs of flutriafol
and imazalil sulphate
4.10
4.11
As indicated in Paragraph 4.6 above, the only potentially non-negligible risks
identified by the Committee are those that relate to human health. With respect to
these risks, the Committee is satisfied that:

the risks posed to public health are negligible as the substances are only intended
for use in the formulation of pesticides and they will not be widely available or
prevalent outside of the workplace;

the risks posed to occupational health are also negligible as, during handling of the
substances in the workplace, exposure to the substances is voluntary and
persons handling the substances will be aware of the hazards, the risks posed
and measures that need to be undertaken to ensure their own safety.
Accordingly, the Committee is satisfied that the overall level of risk associated with
the substances is negligible.
5 Controls
5.1
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.
Exposure Limits
Setting of exposure limits and application rates for flutriafol and imazalil sulphate
5.2
Control T1 relates to the requirement to limit public exposure to toxic substances
by the setting of Tolerable Exposure Limits (TELs), which are derived from
Acceptable Daily Exposure (ADE) values. The Authority has not previously set a
TEL for formulations containing flutriafol or imazalil sulphate or for the
components per se. Consequently, the Committee has not set any TEL values for
flutriafol and imazalil sulphate until implementation of a pending review of setting
such values under section 77B. The Committee notes that an MRL has been set by
the NZFSA for imazalil residues in citrus.
5.3
Control T2 relates to the requirement to limit worker exposure to toxic substances
by the setting of Workplace Exposure Standards (WESs). The Committee notes
that no WES values have been set for flutriafol and imazalil sulphate by the
Department of Labour and that there is insufficient data available to set such a
standard. Consequently, the Committee has not set any WESs for flutriafol and
imazalil sulphate at this time.
5.4
Control E1 relates to the requirements to limit exposure of non-target organisms in
the environment through the setting of Environmental Exposure Limits (EELs).
Following the enactment of the Hazardous Substances and New Organisms
(Approvals and Enforcement) Act 2005, the Authority is intending to review the
setting of EELs under section 77B. Consequently, the Committee has not set any
EELs for flutriafol and imazalil sulphate set at this time and has deleted the default
EEL water values.
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5.5
Control E2 relates to the requirement to set an application rate for class 9
substances that are sprayed onto an area of land (or air or water) and for which an
EEL has been set. The Committee notes that these substances are technical grade
substances intended for inclusion into pesticidal products and are not for
application in their own right. As such the Committee does not consider that
application rates are applicable to either substance and has deleted this control.
The Committee notes that application rates will be considered when approving
substances containing imazalil sulphate and/or flutriafol.
Additional controls under section 77A
5.6
Under section 77A, the Authority may impose as controls any obligations and
restrictions that it 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.
5.7
As no information has been provided regarding the manufacture of flutriafol or
imazalil sulphate the risks associated with their manufacture cannot be determined,
for example, the risk associated with manufacturing by-products. Consequently,
the Committee considers that this approval should be restricted to the importation
of the substances only. Accordingly, the Committee sets the following control for
both flutriafol and imazalil sulphate under section 77A(4)(c) as it considers that this
control will be more likely to achieve its purpose than any other control as no other
control manages this area of risk:
Flutriafol / Imazalil sulphate shall only be imported and shall not be manufactured in New
Zealand.
5.8
The Committee considers that the controls relating to the specification and
prohibition on use, consistent with Schedule 3 of the Hazardous Substances
(Chemicals) Transfer Notice (New Zealand Gazette Issue No. 72, 28 June 2006)
should be applied to flutriafol and imazalil sulphate. The Committee has set the
following controls, under section 77A(4)(c), as it considers the controls are more
likely to achieve their purpose than any other control because no other controls as
specified manage this area.
(1)
Prohibition on use of flutriafol and imazalil sulphate
(1)
No person may use flutriafol or imazalil sulphate for any purpose other than –
(a) for research and development; or
(b) as an ingredient or component in the manufacture of another substance or product.
(2)
Despite subclause (1)(a), research and development using flutriafol or imazalil sulphate
does not include investigation or experimentation in which the substance is discharged,
laid or applied in or to the outdoor environment.
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(2)
Specification of flutriafol and imazalil sulphate
(1)
Any person who (a) imports into New Zealand flutriafol or imazalil sulphate, which that person has
not previously imported; or
(b) had previously imported flutriafol or imazalil sulphate, but has since changed the
source of manufacture for that hazardous substance,
must provide to the Authority in writing the information required by subclauses (3)
and (4).
(2)
The information required by subclause (1) must be provided –
(a) prior to the substance being imported; and
(b) in the case of flutriafol or imazalil sulphate to which subclause (1)(b) applies –
(i) each and every time the source of manufacture is changed; and
(ii) include equivalent information for the substance that was supplied by the
previous source of manufacture, if such information has not previously been
provided to the Authority.
(3)
The information to be provided is (a) the name and address of the manufacturer of flutriafol or imazalil sulphate (as
appropriate);
(b) the specification of flutriafol or imazalil sulphate (as appropriate) including –
the manufacturer’s specifications including purity of the hazardous substance,
isomeric ratio where applicable, maximum impurity content and evidence to
support these, including details of analytical methods used. Where flutriafol or
imazalil sulphate is produced at more than one manufacturing site, this
information must be provided for each site separately;
(c) the identity of any impurity, its origin, and the nature of its relationship to the
active component when the impurity is present at a concentration of 10g/kg or
more;
(d) the identity of any impurity that is known to be of toxicological concern, its origin,
and the nature of its relationship to the active component when the impurity is
present at a concentration of less than 10g/kg.
(4)
Information on an impurity that is required under subclause (3) must include –
(a) its chemical name;
(b) its Chemical Abstract Service Registry number (if available); and
(c) its maximum concentration in the substance.
Variation of controls for flutriafol and imazalil sulphate
5.9
Under section 77, the default controls triggered for a substance may be varied.
Under section 77(3), controls may be substituted or added. Under section 77(4),
controls may be substituted or deleted. Under section 77(5), where a substance
triggers more than one hazard classification, controls may be combined.
5.10
The Committee considers that the following controls should be varied under
section 77(4)(a), as the adverse effects of the substances are less than the adverse
effects which would normally be associated with substances of the same hazard
classifications:
ERMA New Zealand Decision: Application HSR07035
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5.10.1
5.11
Control T3 relates to the requirement for keeping records of use of highly
toxic or corrosive substances if the application is in an area where
members of the public may be present, or where the substance is likely to
enter air or water and leave the place. This control is not considered
relevant because the use of flutriafol and imazalil sulphate is restricted to
use as ingredients in pesticidal formulations. Consequently, the
Committee has deleted control T3 for both flutriafol and imazalil
sulphate.
The Committee considers that the following controls should be varied, under
section 77(4)(b), for flutriafol and imazalil sulphate (as specified), as the variations
will not significantly increase the adverse effects of the substances:
5.11.1
Controls T6, E7 and AH1 relate to requirements for certain toxic and
ecotoxic substances to be under the control of an approved handler. The
Committee considers that, because of flutriafol’s relatively high acute
toxicity and limited lifecycle, controls T6 and E7 should be combined
and modified for flutriafol so that it must be secured when left
unattended. Accordingly, the Committee has substituted the following
control for Regulation 9 of the Hazardous Substances (Classes 6, 8, and 9
Controls) Regulations 2001 for flutriafol:
“Flutriafol, when left unattended, must be secured so that a person cannot gain access to
the substance unless that person has a key or other device used for operating locks.
5.12
5.11.2
Control E5 relates to requirements to keep records where certain ecotoxic
substances are applied for the purpose of causing biocidal action and the
substance is likely to leave that place. Due to the limited lifecycle of
imazalil sulphate and the use restriction proposed the Committee has
deleted this control for imazalil sulphate.
5.11.3
Controls E7 and AH1 relate to requirements for certain ecotoxic
substances to be under the control of an approved handler. The
Committee considers that these controls are not relevant to
imazalil sulphate, given that the substance is not used in a wide
dispersive manner and is consequently of a lesser risk to the environment.
Thus, the Committee has deleted these controls for imazalil sulphate.
5.11.4
Control TR1 relates to the requirements for a substance to be tracked. As
the lifecycles of the substances are limited, the Committee considers that
any risks arising throughout their lifecycles should be adequately managed
by other controls, such as packaging, labelling and emergency
management. Consequently the Committee has deleted control TR1 for
both flutriafol and imazalil sulphate.
The Committee has combined the following controls under section 77(5) as they
relate to the same requirements:
5.12.1
Controls T4 and E6 which relate to requirements for equipment used to
handle either flutriafol or imazalil sulphate.
ERMA New Zealand Decision: Application HSR07035
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5.12.2
Controls P13 and P15 which relate to requirements for packaging
flutriafol.
5.12.3
Controls P13, P14 and P15 which relate to requirements for packaging
imazalil sulphate.
5.12.4
Controls D4 and D5 which relate to requirements for disposal of
flutriafol and imazalil sulphate.
6 Overall evaluation of risks and costs
6.1
On the basis of the Agency’s risk assessment and the Committee’s subsequent
evaluation of these risks with the controls in place, it is the Committee’s opinion
that both flutriafol and imazalil sulphate pose:

negligible risks to human health because of their limited lifecycles and where the
exposure potential is greatest the risks are knowingly and voluntarily faced;

negligible risks to the environment given their limited lifecycle;

negligible risks to Māori in terms of obligations under the Treaty of Waitangi,
and to their culture and traditions with their ancestral lands, water, sites, wāhi
tapu, valued flora and fauna and other taonga;

negligible risks to society, community, the market economy or to New Zealand’s
international obligations.
7 Comparison of risks, cost and benefits
7.1
In assessing the risks, costs and benefits associated with approval of these
substances in New Zealand, the Committee considers that, because the risks are
negligible, the application may be considered under clause 26.
7.2
As the risks associated with substances are negligible and benefits have been
identified, the Committee is satisfied that it is evident that the benefits outweigh the
costs associated with them.
8 Recommendations
8.1
The Committee recommends that, should inappropriate or accidental use, transport
or disposal of either flutriafol or imazalil sulphate result in the contamination of the
environment or a body of water, 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.
ERMA New Zealand Decision: Application HSR07035
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9 Environmental User Charges
9.1
The Committee considers that the application of controls to flutriafol and imazalil
sulphate will provide 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 these substances as an alternative or
additional means of achieving effective risk management.
10 Decision
10.1
The Committee determines that:

Flutriafol has the following hazard classification:
Hazardous Property
Acute oral toxicity
Acute inhalation toxicity
Eye irritancy
Reproductive/ Developmental toxicity
Target organ toxicity
Aquatic ecotoxicity
Terrestrial vertebrate ecotoxicity

Classification
6.1C
6.1D
6.4A
6.8B
6.9B
9.1B
9.3B
Imazalil sulphate has the following hazard classification:
Hazardous Property
Acute oral toxicity
Acute inhalation toxicity
Eye corrosivity
Target organ toxicity
Aquatic ecotoxicity
Terrestrial vertebrate ecotoxicity
Classification
6.1D
6.1D
8.3A
6.9B
9.1A
9.3B

pursuant to section 29 and clause 26, the positive effects (benefits) of flutriafol
and imazalil sulphate are considered to outweigh the adverse effects (risks and
costs) associated with the substances throughout their lifecycles in New Zealand;

the application for importation and use of the hazardous substance, flutriafol, as
a component in the manufacture of other substances is thus approved with
controls as listed in Appendix 1;

the application for importation and use of the hazardous substance,
imazalil sulphate, as a component in the manufacture of other substances is
thus approved with controls as listed in Appendix 2.
10.2
In accordance with clause 36(2)(b), the Committee records that, in reaching this
conclusion, it has applied the balancing tests in section 29 and clause 26.
10.3
It has also applied the following criteria in the Methodology:
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











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
clause 21 – the decision accords with the requirements 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 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.
Professor George Clark
Date: 29 August 2007
Chair
Substance Identifier
ERMA New Zealand Approval Code:
Flutriafol
HSR007834
Imazalil sulphate
HSR007835
ERMA New Zealand Decision: Application HSR07035
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Appendix 1: Controls for flutriafol
Note: The control explanations as listed below have been provided as guidance only and do not have legal standing.
Please refer to the regulations for the requirements prescribed for each control and the modifications listed set out in
section 5 of this document.
Control
Code1
Regulation2
Topic
Proposed variations
Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001
T1
11-27
Limiting exposure to toxic substances
Flutriafol
TELFLUTRIAFOL None set at this time.
T2
29, 30
Controlling exposure in places of
work
Flutriafol
WESFLUTRIAFOL None set at this time.
T4/E6
7
Requirements for equipment used to
handle hazardous substances
Controls T4 and E6 are combined
T5
8
Requirements for protective clothing
and equipment
T6 & E7
9
Approved handler requirements
T7
10
Restrictions on the carriage of
hazardous substances on passenger
service vehicles
E1
32-45
Limiting exposure to ecotoxic
substances
The following clause has been
substituted in place of Regulation 9 :
Flutriafol, when left unattended, must be
secured so that a person cannot gain access to
the substance unless that person has a key or
other device used for operating locks.
Flutriafol
EELFLUTRIAFOL None set at this time.
Hazardous Substances (Identification) Regulations 2001
I1
6, 7, 32-35,
36 (1)-(7)
General identification requirements
Regulation 6 – Identification duties of
suppliers
Regulation 7 – Identification duties of
persons in charge
Regulations 32 and 33 – Accessibility
of information
Regulations 34, 35, 36(1)-(7) –
Comprehensibility, Clarity and
Durability of information
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.
1
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Control
Code1
Regulation2
Topic
I3
9
Priority identifiers for ecotoxic
substances
I8
14
Priority identifiers for certain toxic
substances
I9
18
Secondary identifiers for all hazardous
substances
I11
20
Secondary identifiers for ecotoxic
substances
I16
25
Secondary identifiers for toxic
substances
I17
26
Use of Generic Names
I18
27
Use of Concentration Ranges
I19
29-31
Proposed variations
Revised cut-offs for component
labelling required by Regulation 25(e)
HSNO
Classification of
Component
Concentration
Cut-off for
Label (%)
6.5A, 6.5B
0.13
6.6A, 6.7A
0.1
6.6B
1
6.7B
1
6.8A, 6.8C
0.3
6.8B
3
6.9A, 6.9B
10
Alternative information in certain
cases
Regulation 29 – Substances in fixed
bulk containers or bulk transport
containers
Regulation 30 – Substances in multiple
packaging
Regulation 31 – Alternative
information when substances are
imported
I20
36(8)
Durability of information for class 6.1
substances
I21
37-39, 47-50
Documentation required in places of
work
Regulation 37 – Documentation duties
Identification of sensitising components may be required below the 0.1% level if a lower value has been used
for classification.
3
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Control
Code1
Regulation2
Topic
Proposed variations
of suppliers
Regulation 38 – Documentation duties
of persons in charge of places of work
Regulation 39 – General content
requirements for documentation
Regulation 47 – Information not
included in approval
Regulation 48 – Location and
presentation requirements for
documentation
Regulation 49 – Documentation
requirements for vehicles
Regulation 50 – Documentation to be
supplied on request
I23
41
Specific documentation requirements
for ecotoxic substances
I28
46
Specific documentation requirements
for toxic substances
I29
51-52
Duties of persons in charge of places
with respect to signage
I30
53
Advertising toxic substances
Hazardous Substances (Packaging) Regulations 2001
P1
5, 6, 7 (1), 8
General packaging requirements
Regulation 5 – Ability to retain
contents
Regulation 6 – Packaging markings
Regulation 7(1) – Requirements when
packing hazardous substance
Regulation 8 – Compatibility
Regulation 9A and 9B – Large
Packaging
P3
9
Packaging requirements for substances
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Control
Code1
Regulation2
Topic
Proposed variations
packed in limited quantities
P13
P15
19, 21
Packaging requirements for TNL 2339
PG3
Schedule 3
The tests in Schedule 3 correlate to
the packaging requirements of UN
Packing Group III (UN PGIII).
PS4
Schedule 4
This schedule describes the minimum
packaging requirements that must be
complied with when a substance is
packaged in limited quantities
Controls P13 and P15 are combined
Hazardous Substances (Disposal) Regulations 2001
D4
D5
8
9
Disposal requirements for TNL 2339
D6
10
Disposal requirements for packages
D7
11, 12
Disposal information requirements
D8
13, 14
Disposal documentation requirements
Controls D4 and D5 are combined
Hazardous Substances (Emergency Management) Regulations 2001
EM1
6, 7, 9-11
Level 1 emergency management
information: General requirements
EM6
8(e)
Information requirements for toxic
substances
EM7
8(f)
Information requirements for ecotoxic
substances
EM8
12-16, 18-20
Level 2 emergency management
documentation requirements
EM11
25-34
Level 3 emergency management
requirements – emergency response
plans
EM13
42
Level 3 emergency management
requirements – signage
Hazardous Substances (Personnel Qualification) Regulations 2001
AH1
4-6
Approved Handler requirements
Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004
Regulations 4 to 43
where applicable
The Hazardous Substances (Tank Wagons and Transportable Containers)
Regulations 2004 prescribe a number of controls relating to tank wagons and
transportable containers and must be complied with as relevant.
Section 77A Additional Controls
Flutriafol shall only be imported and shall not be manufactured in New Zealand.
(1)
Prohibition on use of flutriafol
(1)
No person may use flutriafol for any purpose other than –
(a) for research and development; or
(b) as an ingredient or component in the manufacture of another substance or product.
ERMA New Zealand Decision: Application HSR07035
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Control
Code1
Regulation2
Topic
Proposed variations
(2)
Despite subclause (1)(a), research and development using flutriafol does not include investigation or
experimentation in which the substance is discharged, laid or applied in or to the outdoor
environment.
(2)
Specification of flutriafol
(1)
Any person who (a) imports into New Zealand flutriafol, which that person has not previously imported; or
(b) had previously imported flutriafol, but has since changed the source of manufacture for that
hazardous substance,
must provide to the Authority in writing the information required by subclauses (3) and (4).
(2)
The information required by subclause (1) must be provided –
(a) prior to the substance being imported; and
(b) in the case of flutriafol to which subclause (1)(b) applies –
(i) each and every time the source of manufacture is changed; and
(ii) include equivalent information for the substance that was supplied by the previous
source of manufacture, if such information has not previously been provided to the
Authority.
(3)
The information to be provided is (a) the name and address of the manufacturer of flutriafol (as appropriate);
(b) the specification of flutriafol (as appropriate) including –
the manufacturer’s specifications including purity of the hazardous substance, isomeric
ratio where applicable, maximum impurity content and evidence to support these,
including details of analytical methods used. Where flutriafol is produced at more than
one manufacturing site, this information must be provided for each site separately;
(c) the identity of any impurity, its origin, and the nature of its relationship to the active
component when the impurity is present at a concentration of 10g/kg or more;
(d) the identity of any impurity that is known to be of toxicological concern, its origin, and the
nature of its relationship to the active component when the impurity is present at a
concentration of less than 10g/kg.
(4)
Information on an impurity that is required under subclause (3) must include –
(a) its chemical name;
(b) its Chemical Abstract Service Registry number (if available); and
(c) its maximum concentration in the substance.
ERMA New Zealand Decision: Application HSR07035
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Appendix 2: Controls for imazalil sulphate
Note: The control explanations as listed below have been provided as guidance only and do not have legal standing.
Please refer to the regulations for the requirements prescribed for each control and the modifications listed set out in
section 5 of this document.
Control
Code4
Regulation5
Topic
Proposed variations
Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001
T1
11-27
Limiting exposure to toxic substances
Imazalil sulphate
TELIMAZALIL SULPHATE
time.
T2
29, 30
None set at this
Controlling exposure in places of
work
Imazalil sulphate
Controls T4 and E6 are combined
T4/E6
7
Requirements for equipment used to
handle hazardous substances
T5
8
Requirements for protective clothing
and equipment
T7
10
Restrictions on the carriage of
hazardous substances on passenger
service vehicles
E1
32-45
Limiting exposure to ecotoxic
substances
WESIMAZALIL SULPHATE
time.
None set at this
Imazalil sulphate
EELIMAZALIL SULPHATE
time.
None set at this
Hazardous Substances (Identification) Regulations 2001
I1
6, 7, 32-35,
36 (1)-(7)
General identification requirements
Regulation 6 – Identification duties of
suppliers
Regulation 7 – Identification duties of
persons in charge
Regulations 32 and 33 – Accessibility
of information
Regulations 34, 35, 36(1)-(7) –
Comprehensibility, Clarity and
Durability of information
I2
8
Priority identifiers for corrosive
substances
I3
9
Priority identifiers for ecotoxic
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.
4
ERMA New Zealand Decision: Application HSR07035
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Control
Code4
Regulation5
Topic
Proposed variations
substances
I8
14
Priority identifiers for certain toxic
substances
I9
18
Secondary identifiers for all hazardous
substances
10
19
Secondary identifiers for corrosive
substances
I11
20
Secondary identifiers for ecotoxic
substances
I16
25
Secondary identifiers for toxic
substances
I17
26
Use of Generic Names
I18
27
Use of Concentration Ranges
I19
29-31
Revised cut-offs for component
labelling required by Regulation 25(e)
HSNO
Classification of
Component
Concentration
Cut-off for
Label (%)
6.5A, 6.5B
0.16
6.6A, 6.7A
0.1
6.6B
1
6.7B
1
6.8A, 6.8C
0.3
6.8B
3
6.9A, 6.9B
10
Alternative information in certain
cases
Regulation 29 – Substances in fixed
bulk containers or bulk transport
containers
Regulation 30 – Substances in multiple
packaging
Regulation 31 – Alternative
information when substances are
imported
I20
36(8)
Durability of information for class 6.1
substances
I21
37-39, 47-50
Documentation required in places of
work
Identification of sensitising components may be required below the 0.1% level if a lower value has been used
for classification.
6
ERMA New Zealand Decision: Application HSR07035
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Control
Code4
Regulation5
Topic
Proposed variations
Regulation 37 – Documentation duties
of suppliers
Regulation 38 – Documentation duties
of persons in charge of places of work
Regulation 39 – General content
requirements for documentation
Regulation 47 – Information not
included in approval
Regulation 48 – Location and
presentation requirements for
documentation
Regulation 49 – Documentation
requirements for vehicles
Regulation 50 – Documentation to be
supplied on request
I22
40
Specific documentation requirements
for corrosive substances
I23
41
Specific documentation requirements
for ecotoxic substances
I28
46
Specific documentation requirements
for toxic substances
I29
51-52
Duties of persons in charge of places
with respect to signage
I30
53
Advertising toxic substances
Hazardous Substances (Packaging) Regulations 2001
P1
5, 6, 7 (1), 8
General packaging requirements
Regulation 5 – Ability to retain
contents
Regulation 6 – Packaging markings
Regulation 7(1) – Requirements when
packing hazardous substance
Regulation 8 – Compatibility
ERMA New Zealand Decision: Application HSR07035
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Control
Code4
Regulation5
Topic
Proposed variations
Regulation 9A and 9B – Large
Packaging
P3
9
Packaging requirements for substances
packed in limited quantities
P13
P14
P15
19
20
21
Packaging requirements for imazalil
sulphate
PG3
Schedule 3
The tests in Schedule 3 correlate to
the packaging requirements of UN
Packing Group III (UN PGIII).
PS4
Schedule 4
This schedule describes the minimum
packaging requirements that must be
complied with when a substance is
packaged in limited quantities
Controls P13, P14 and P15 are
combined
Hazardous Substances (Disposal) Regulations 2001
D4
D5
8
9
Disposal requirements for TNL 2339
D6
10
Disposal requirements for packages
D7
11, 12
Disposal information requirements
D8
13, 14
Disposal documentation requirements
Controls D4 and D5 are combined
Hazardous Substances (Emergency Management) Regulations 2001
EM1
6, 7, 9-11
Level 1 emergency management
information: General requirements
EM2
8(a)
Information requirements for
corrosive substances
EM6
8(e)
Information requirements for toxic
substances
EM7
8(f)
Information requirements for ecotoxic
substances
EM8
12-16, 18-20
Level 2 emergency management
documentation requirements
EM11
25-34
Level 3 emergency management
requirements – emergency response
plans
EM13
42
Level 3 emergency management
requirements – signage
Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004
Regulations 4 to 43
where applicable
The Hazardous Substances (Tank Wagons and Transportable Containers)
Regulations 2004 prescribe a number of controls relating to tank wagons and
transportable containers and must be complied with as relevant.
Section 77A Additional Controls
Imazalil sulphate shall only be imported and shall not be manufactured in New Zealand.
(1)
Prohibition on use of imazalil sulphate
ERMA New Zealand Decision: Application HSR07035
Page 20 of 21
Control
Code4
Regulation5
Topic
Proposed variations
(1)
No person may use imazalil sulphate for any purpose other than –
(a) for research and development; or
(b) as an ingredient or component in the manufacture of another substance or product.
(3)
Despite subclause (1)(a), research and development using imazalil sulphate does not include
investigation or experimentation in which the substance is discharged, laid or applied in or to the
outdoor environment.
(2)
Specification of imazalil sulphate
(1)
Any person who (a) imports into New Zealand imazalil sulphate, which that person has not previously imported;
or
(b) had previously imported imazalil sulphate, but has since changed the source of manufacture
for that hazardous substance,
must provide to the Authority in writing the information required by subclauses (3) and (4).
(2)
The information required by subclause (1) must be provided –
(a) prior to the substance being imported; and
(b) in the case of imazalil sulphate to which subclause (1)(b) applies –
(i) each and every time the source of manufacture is changed; and
(ii) include equivalent information for the substance that was supplied by the previous
source of manufacture, if such information has not previously been provided to the
Authority.
(3)
The information to be provided is (a) the name and address of the manufacturer of imazalil sulphate (as appropriate);
(b) the specification of imazalil sulphate (as appropriate) including –
the manufacturer’s specifications including purity of the hazardous substance, isomeric
ratio where applicable, maximum impurity content and evidence to support these,
including details of analytical methods used. Where imazalil sulphate is produced at
more than one manufacturing site, this information must be provided for each site
separately;
(e) the identity of any impurity, its origin, and the nature of its relationship to the active
component when the impurity is present at a concentration of 10g/kg or more;
(f) the identity of any impurity that is known to be of toxicological concern, its origin, and the
nature of its relationship to the active component when the impurity is present at a
concentration of less than 10g/kg.
(4)
Information on an impurity that is required under subclause (3) must include –
(a) its chemical name;
(b) its Chemical Abstract Service Registry number (if available); and
(c) its maximum concentration in the substance.
ERMA New Zealand Decision: Application HSR07035
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