APPLICATION FORM
CHEMICAL PESTICIDES
To obtain approval for the import or
manufacture of chemical pesticides
under section 28 of the Hazardous Substances and New Organisms Act 1996
Send by post to: Environmental Protection Authority, PO Box 131, Wellington 6140 OR email to: hsinfo@epa.govt.nz
Name of the mixture(s) to be approved
Applicant
Date
OFFICE USE ONLY
Application Code
Date received
EPA Contact
Application Version No
www.epa.govt.nz
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Import or Manufacture a Hazardous Substance Chemical Pesticides
Completing this application form
1. This application form is approved under the Hazardous Substances and New Organisms Act 1996, but is only to
be used by Dow AgroSciences for up to 5 applications for approval to import or manufacture a hazardous
substance. This application form must not be used for any other application under the Hazardous Substances
and New Organisms Act 1996.
2. It is recommended that you contact an Applications Advisor at the Environmental Protection Authority (EPA) as
soon as possible. An Applications Advisor can help you scope and prepare your application.
3. Prior to submitting this application, you may make an informal Status of Substance (SOS) advice request to the
EPA (www.epa.govt.nz/hazardous-substances/about/SOS). Please note that SOS advice from the EPA is not
mandatory, is only informal and cannot be relied on.
4. If you supply any information relating to your application to the EPA, this will be held by the EPA on your behalf
and will not be publicly released until your application has been formally lodged. Such information may be
returned or deleted on request. You may provide this information electronically if you wish.
5. Please ensure that you obtain all appropriate permissions for the use of any data that you have used or
provided in this application form, if you are not the owner of such data.
6. This application form may be used to seek approvals for more than one hazardous substance, if the substances
and uses are of a similar nature.
7. Unless otherwise indicated, all sections of this form must be completed for the application to be progressed.
8. Any extra material that does not fit in the application form must be clearly labelled, cross-referenced, and
included as appendices to the application form.
9. Please add additional rows/tables where needed.
10. The application form may be completed manually or electronically; however, the form must be signed manually.
You may print the application form to do this, then scan and submit the application form by email or by post.
11. This form should be directed to:
Environmental Protection Authority
20 Customhouse Quay
P O Box 131
Wellington 6140
New Zealand
Telephone: 64 4 916 2426
Facsimile: 64 4 914 0433
E-mail: hsinfo@epa.govt.nz
www.epa.govt.nz
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Import or Manufacture a Hazardous Substance Chemical Pesticides
Commercially sensitive information
12. Commercially sensitive information should be placed in the confidential section of the application and a crossreference made to that information in the body of the application.
13. Once you have formally lodged your application with the EPA, any information you have supplied to the EPA in
respect of your application is subject to the Official Information Act 1982 (OIA). If a request is made for the
release of information that you have claimed is confidential, this will be considered in a manner consistent with
the OIA and section 57 of the HSNO Act. You may be required to provide further justification for your claim of
confidentiality.
Definitions
Active ingredient(s)
Component of a mixture responsible for the pesticidal effect of the mixture.
Approved EPA customer
In order to be recognised by the EPA as an “Approved EPA customer”, the applicant
must have: submitted more than one application per month over the last six months;
and no history of delay in making payment at the time of presenting an application.
Biopesticide
Biopesticides are certain types of pesticides derived from such natural materials as
animals, plants, bacteria, and certain minerals. Biopesticides fall into three major
classes:
 Microbial pesticides consist of a microorganism (e.g., a bacterium, fungus, virus or
protozoan) as the active ingredient. Microbial pesticides can control many different
kinds of pests, although each separate active ingredient is relatively specific for its
target pest[s]. For example, there are fungi that control certain weeds, and other
fungi that kill specific insects.
 The most widely used microbial pesticides are subspecies and strains of Bacillus
thuringiensis, or Bt. Each strain of this bacterium produces a different mix of
proteins, and specifically kills one or a few related species of insect larvae. While
some Bt's control moth larvae found on plants, other Bt's are specific for larvae of
flies and mosquitoes. The target insect species are determined by whether the
particular Bt produces a protein that can bind to a larval gut receptor, thereby
causing the insect larvae to starve.
 Plant-Incorporated-Protectants (PIPs) are pesticidal substances that plants produce
from genetic material that has been added to the plant. For example, scientists can
take the gene for the Bt pesticidal protein, and introduce the gene into the plant's
own genetic material. Then the plant, instead of the Bt bacterium, manufactures the
substance that destroys the pest. The protein and its genetic material, but not the
plant itself, are regulated by EPA.
Chemical pesticide
Any chemical mixture of substances intended for preventing, destroying or controlling
any pest, including vectors of human or animal disease, unwanted species of plants or
animals causing harm during or otherwise interfering with the production, processing,
storage, transport or marketing of food, agricultural commodities, wood and wood
products or animal feedstuffs, or substances which may be administered to animals for
the control of insects, arachnids or other pests in or on their bodies. The term includes
mixtures intended for use as a plant growth regulator, defoliant, desiccant or agent for
thinning fruit or preventing the premature fall of fruit. Also used as substances applied
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Import or Manufacture a Hazardous Substance Chemical Pesticides
to crops either before or after harvest to protect the commodity from deterioration
during storage and transport. Subclasses of pesticides include: herbicides,
insecticides, fungicides, rodenticides, pediculicides, and biocides.
Containment
Has the same meaning as in the HSNO Act
Emergency
Has the same meaning as in section 46 of the HSNO Act
Hazardous substance
Has the same meaning as in the HSNO Act
Industrial chemical
Chemicals developed or manufactured for use in industrial operations or
research by industry, government, or academia. These chemicals are not
primarily manufactured for the specific purpose of producing human
casualties or rendering equipment, facilities, or areas dangerous for human
use.
Mixture
Means a hazardous substance as defined in the HSNO Act.
Reference substance
Mixture already approved under the HSNO Act.
Relabelling
Action of changing the label of a mixture intended to be imported in New Zealand to
meet the EPA criteria in terms of information content for New Zealand. This action can
also occur when the mixture is repacked into final market packaging or packaging of
different sizes.
Repackaging
Transfer of a mixture from one container to another without a change in composition of
the mixture or the labelling content, for sale or distribution.
Safety Data Sheet (SDS)
Requirements for documentation for hazardous substances in places of work set out in
Part 2 of the Hazardous Substances (Identification) Regulations 2004 and as more
particularly described in the Approved Code of Practice under the HSNO Act 1996,
Preparation of Safety Data Sheets, HSNO CoP 8-1 09-06, New Zealand Industry
Council, September 2006.
Special emergency
Means a special emergency declared under section 49B of the HSNO Act.
Substance
Has the same meaning as in the HSNO Act.
Veterinary medicine
(A) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention
of disease in/on animals (other than man); and (B) articles (other than food) intended
to affect the structure or any function of the body of animals (other than man); and
articles intended for use as a component of any articles specified in clause (A) or (B).
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Import or Manufacture a Hazardous Substance Chemical Pesticides
1. Applicant and Manufacturer(s) details
1. Please make sure to include any commercially sensitive information in the confidential section of this form.
1.1. Applicant1
Company Name:
Contact Name:
Job Title:
Physical Address:
Postal Address (provide only if not the same as the physical):
Phone (office and/or mobile):
Fax:
Email:
1.2. New Zealand agent or consultant (if applicable)
Company Name:
Contact Name:
Job Title:
Physical Address:
Postal Address (provide only if not the same as the physical):
Phone (office and/or mobile):
Fax:
Email:
1 All
formal correspondence/invoice will be sent to the contact person for the application identified in this sub-section.
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1.3. Manufacturer(s) details (for the active ingredient)
Company Name:
Contact Name:
Job Title:
Actual site of manufacture (address):
Physical Address:
Postal Address (provide only if not the same as the physical):
Phone (office and/or mobile):
Fax:
Email:
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2. Information about the application
2.1. Purpose statement of the application
1. This will be published on the EPA public register.
2. Briefly describe the mixture to be imported or manufactured for release and the purpose for which you wish to release the mixture.)
Maximum of 255 characters including spaces and punctuation.
Example: to seek approval under the HSNO Act to import or manufacture <name of the mixture> intended to be used as
<function of mixture> for the control of <use of the mixture>
2.2. Executive summary
1. Complete the following table.
2. Include any commercially sensitive information in the confidential section of this form.
Name of mixture
Name of active ingredient
Physical description
Hazardous properties
Use
Significant risks
2.3. Type of application
1. Tick the box(es) that best describe your application.
Does the proposed mixture have a similar composition and similar hazardous properties to a Reference
Substance?
Yes
No
Has the proposed mixture been formulated so that 1 or more of its hazardous properties has a lesser degree of
hazard than a Reference Substance?
Yes
If you have answered yes to either of the above questions, please identity the Reference Substance:
Name of Reference Substance
EPA approval number
Use patterns of Reference Substance
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HSR00XXXX
No
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Import or Manufacture a Hazardous Substance Chemical Pesticides
Does the proposed mixture have 1 or more hazardous properties, and does each hazardous property have the
least degree of hazard for that property?
Yes
No
If you have answered yes to the above question, please identify each of the hazardous properties and each
applicable degree of hazard:
Is the active ingredient new to New Zealand?
Yes
No
Yes
No
Is the substance that is the subject of this application is also the subject of:
a. an innovative medicine application as defined in section 23A of the Medicines Act 1981.
b. an innovative agricultural compound application as defined in Part 6 of the Agricultural Compounds and
Veterinary Medicines Act 1997.
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Yes
No
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Import or Manufacture a Hazardous Substance Chemical Pesticides
3. Identity of the hazardous substance(s)
1. Include any commercially sensitive information in the confidential section of this form.
2. Provide details on the active ingredient(s) as well as the mixture in this section.
3.1. Identity of the active ingredient(s):
1. Copy and paste information if necessary.
Active ingredient (Common name):
Chemical name (IUPAC):
Chemical name (CA):
Molecular formula:
Structural formula:
Manufacturer’s development codes:
CIPAC No:
CAS No:
Function:
Herbicide
Fungicide
Insecticide
Other (specify):
FAO Specification (including year of publication):
Yes
Plant growth regulator
No
Minimum purity of the active ingredient as manufactured (g/kg):
3.2. Specification of purity of active ingredient(s)
1. Include the acceptable range for each minimum purity of the active ingredient(s) as manufactured (g/kg)
2. Indentify, quantify and report any impurities where the toxicology and ecotoxicology is known and of no concern and which are
present at a concentration of 10 g/kg or more
3. Indentify, quantify and report any impurities of toxicological/residue concern present at any level, including those present at less than
10 g/kg (1%)
4. Indentify, quantify and report any impurities where the toxicology and ecotoxicology is unknown and which are present at any level
Details of significant impurities must include:
Name:
CAS number:
Structural formula:
Quantity (S.I. units) :
Maximum allowable limits :
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3.3. Analytical profile of batches and validated analytical methods for the active ingredient(s)/Test
procedures
1. This can be provided as full reports. It is acceptable to only provide the Australian Pesticides and Veterinary Medicines Authority
(APVMA) reference when the source of the active ingredient has already been approved in Australia.
3.4. International regulatory status of the active ingredient(s)
Regulatory status
Jurisdiction
Never
approved
Pending
Approved
Restricted
Not
renewed
Comment*
Australia
Canada
Europe
Japan
New Zealand
USA
Other
jurisdictions
(specify below)
*For
instance specify here under which regulation(s)/directive(s)
When restricted or not renewed, explanations should be provided:
3.5.
Identity of the mixture
Manufacturer’s development codes:
Unique name for public register:
Function
Herbicide
Fungicide
Insecticide
Vertebrate toxic agent
Fumigant
Other (specify)
Active ingredient(s) content (g/kg or L and % w/w): g/kg or L
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% (w/w)
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3.6.
International regulatory status of the mixture2
Regulatory status
Jurisdiction
Never
approved
Pending
Approved
Restricted
Not
renewed
Comment*
Australia
Canada
Europe
Japan
USA
Other
jurisdictions
specify below
*For
instance specify here under which regulation(s)/directive(s)
2
The mixture intended to be imported/manufactured in New Zealand must be identical to the mixture already approved in other
jurisdictions. Contact the EPA for further information if needed.
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3.7.
Composition details of the mixture
1. Full composition details must be supplied.
Full details are provided below
I have arranged for the owner of the mixture details who granted the rights to handle the approval of the mixture
in New Zealand to provide details to the EPA using a copy of this page.
Owner of the mixture
details
Physical address
Postal address
Provide only if not the same
as the physical
Postal address
Phone
Switchboard number
Fax
E-mail
For every ingredient in the mixture, each column must be completed
CAS
number3
Ingredient name4
Function5
Concentration
(g/L or g/kg) –
Min and Max
Concentration
(%) – Min and Max
Total weight/weight (solids) or weight/volume (liquids)
Specific gravity (liquids only)
3
When applicable
Including purity details where relevant, e.g. 95% purity, sufficient to give 100 g/L. Trade names cannot be used on their own. If
trade name products are used as an ingredient, provide full mixtures of all trade name products used, or arrange to have
complete mixtures sent directly to the EPA by the supplier.
5 The purpose of the ingredient in the mixture (e.g. solvent, binder, preservative etc Do not use ‘inert’)
4
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3.8.
Manufacturing, importation, transport, packaging and disposal of the mixture6 in New Zealand
Manufacturing
Is your mixture likely to be manufactured in New Zealand?
Yes
No
Sea
Air
Importation
Will your mixture be imported into New Zealand by air and/or sea?
Will your mixture be imported in bulk containers or packaged ready for sale?
Bulk Containers
Packaged ready for sale
If your mixture will be imported in bulk containers, please describe the containers (50 char. max.):
Will repackaging of your mixture be carried out in New Zealand?
Yes
No
Will relabelling of your mixture be carried out in New Zealand?
Yes
No
Please provide any additional relevant information relating to the importation of your mixture (50 char. max.):
Transport
How will your mixture be transported within New Zealand?
Road
Sea
Rail
Air
Please provide any additional information relating to transport of your mixture (50 char. max.):
UN Number:
UN Transport Hazard Classes:
UN Packing Group Number (UN Model Regulations 7):
Marine Pollutant (IMDG Code8):
Packaging
Pack sizes:
6
When it is intended to import/manufacture an active ingredient only, an approval for the active ingredient must be granted first.
Contact the EPA for further information.
7 UN Model Regulations means Model Regulations annexed to the Recommendations on the Transport of Dangerous Goods,
United Nations, 2011 (17th edition)
8 IMDG Code means the International Maritime Dangerous Goods Code, International Maritime Organisation, 2010 (2010
edition)
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Type of packaging:
Type of closure (consider opening size, type of cap, child resistant packaging):
Please provide any additional information relating to the packaging of your mixture:
Disposal
Disposal of empty or damaged packaging, absorbents and other materials:
Detailed instructions for safe disposal of the mixture and its packaging:
3.9.
Manufacturing process of the mixture
1. Attach a copy of the flowchart. It should include typical batch size
3.10. Detail of mixture calculations proposed by the applicant for mixture classification purpose
1. Complete if relevant
3.11. Safety Data Sheet for active ingredient(s) and other ingredients
3.12. Draft New Zealand Safety Data Sheet for the mixture and overseas Safety Data Sheet
1. Complete only if already approved.
3.13. Draft New Zealand label for the mixture
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4. Intended uses of the mixture
4.1. Indicate the intended uses of the mixture.
1. Fill in the table where and as appropriate
Crop and/or
situation (a)
Use
pattern
(b)
Pests or
group of
pests
controlled
(c)
Mixture
Application
Type
Method
and
(d-f)
Conc of
a.i.
(g)
Application rate per
treatment
Number
kind
Growth
stage &
season
(h-i)
(j)
(k)
Min
max
Possible
intervals
between
application
s – days
(minimum)
kg
a.i./hL
min
max
water
L/ha
min
max
kg
a.i./ha
Remarks (l)
min
max
a
Where relevant, the use situation should be described (e.g. fumigation of soil)
b
Outdoor or field use (F), glasshouse application (G), bait station (B), indoor application (I) or other to be specified.
c
e.g. biting and sucking insects, soil borne insects, foliar fungi, weeds
d
e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR)
e
CropLife international, 2008. Technical Monograph no 2, 6th edition. Catalogue of pesticide mixture types and international coding system
f
All abbreviations used must be explained
g
g/kg or g/l or others and to be expressed as acid equivalent when appropriate.
h
Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench, aerial, etc
i
Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plant - type of equipment used must be indicated. If spraying include droplet size spectrum
j
growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell (ISBN 3-8263-3152-4), including where relevant, information on season at time of application
k
Indicate the minimum and maximum number of application possible under practical conditions of use
l
Remarks may include: Extent of use/economic importance/restrictions
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4.2.
Other intended uses
1. Provide details on any other intended uses of the mixture (that have not already been identified in the above table) for the time for
which the mixture is in existence from (and including) its manufacture or importation to its disposal.
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5. HSNO hazard classifications of the mixture
5.1. Identify the HSNO hazard classification of the mixture
1. Fill in the table where and as appropriate
Hazard Class/Subclass
Mixture
classification
Remarks9
Class 1 Explosiveness
Class 2, 3 & 4 Flammability
Class 5 Oxidisers/Organic Peroxides
Subclass 8.1 Metallic corrosiveness
Subclass 6.1 Acute toxicity (oral)
Subclass 6.1Acute toxicity (dermal)
Subclass 6.1 Acute toxicity (inhalation)
Subclass 6.1 Aspiration hazard
Subclass 6.3/8.2 Skin irritancy/corrosion
Subclass 6.4/8.3 Eye irritancy/corrosion
Subclass 6.5A Respiratory sensitisation
Subclass 6.5B Contact sensitisation
Subclass 6.6 Mutagenicity
Subclass 6.7 Carcinogenicity
Subclass 6.8 Reproductive/ developmental toxicity
Subclass 6.8 Reproductive/ developmental toxicity
(known or presumed or suspected)
Subclass 6.8 Reproductive/ developmental toxicity (via
lactation)
Subclass 6.9 Target organ systemic toxicity10
Subclass 9.1 Aquatic ecotoxicity
Subclass 9.2 Soil ecotoxicity
9
10
Justification to be provided
Identify classification for single and/or repeat dose target organ toxicity for oral, dermal or inhalation routes
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Subclass 9.3 Terrestrial vertebrate ecotoxicity
Subclass 9.4 Terrestrial invertebrate ecotoxicity
NA: Not Applicable --> For instance when testing is technically not possible: testing for a specific endpoint may be
omitted, if it is technically not possible to conduct the study as a consequence of the properties of the substance: e.g. very
volatile, highly reactive or unstable substances cannot be used, mixing of the substance with water may cause danger of
fire or explosion or the radio-labelling of the substance required in certain studies may not be possible.
ND: No Data or poor quality data (according to Klimisch criteria11) --> There is a lack of data.
No: Not Classified based on actual relevant data available for the substance --> The data is conclusive and indicates the
threshold for classification is not triggered.
5.2. Please provide information on the identification and assessment of positive 12 and adverse effects13 of
the mixture on the environment, to the extent that this has not already been provided in the above
table:
11
Klimisch, H-J., Andrear, M., & U. Tillmann, 1997. A systematic approach for evaluating the quality of experimental
toxicological and ecotoxicological data. Reg. Toxicol. Pharmacol. 25, 1–5 (1997)
12 Positive effects can include any benefits associated with the importation and manufacture of the mixture.
13 Adverse effects can include any risks and costs associated with the importation and manufacture of the mixture.
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6. Other Information
1. Add any further information you wish to include in this application to this section.
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7. Confidential section
1. At any time the EPA can require you to justify the confidentiality claimed for the information in this section.
2. Please see details in notes on page 3 of this form.
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8. Checklist
Core documentation
Comments/justifications
Covering letter
Yes
All sections of the application form completed
Yes
Commercially sensitive information as part of the
confidential section
Yes
No
Not applicable
Copies of additional references attached
Yes
No
Not applicable
Relevant correspondence
Yes
No
Not applicable
Draft label
Yes
No
Not applicable
Draft Safety Data Sheet
Yes
No
Not applicable
Yes
No
Accountability/Administration
Approved EPA customer
If yes:
Applicant:
Agent:
Application hard copy signed and dated and sent to
the EPA
Yes
Electronic copy of application e-mailed to the EPA
Yes
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9. Signature
I request the EPA to waive any legislative information requirements (i.e. concerning the information that shall
be supplied in my application) that my application does not meet (tick if applicable).
I have completed this application to the best of my ability and, as far as I am aware, the information I have
provided in this application form is correct.
Signed (applicant or person authorised to sign on behalf of the applicant)
Name:
March 2012 EPA0154
Date