ACVM 1-3 Agricultural chemical product data sheet

Approvals Operations Group
Regulation and Assurance
Ministry for Primary Industries
Pastoral House, 25 The Terrace
PO Box 2526, Wellington, New Zealand 6140
Tel: 04 894 2550, fax: 04 894 2566
Email: [email protected]
Agricultural Chemical Product Data Sheet
ACVM 1-3 (August 2014)

This form is to be completed by the Registrant or their nominated New Zealand Agent/Consultant.

Registration (section 21) of a non-exempt ACVM trade name product is required to avoid committing an offence (section 8) under the
Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997.

Under section 10 of the ACVM Act, you must fill out this form as part of your application to register a trade name product. Use the
Agricultural Chemical Product Data Sheet Guide (on the website) to help you.

For new registrations: Send this completed form, all required supporting documentation, and the separate completed application form
(ACVM 1-1) electronically to [email protected].

For variations and updates to this document: You must inform the Ministry for Primary Industries of any changes to the contents of this
document. Complete the variation section on ACVM 1-1, make changes to the relevant page(s) of this PDS, and send electronically to
[email protected].

Refer to the Privacy Act 1993 and Official Information Act 1982 notices at the end of this form regarding collection of information by the
Ministry for Primary Industries.
Part A: General Information
A1 Trade Name of the Agricultural Chemical
See guideline for wording of trade name and list of prohibited substances.
Trade Name
Reg Number (if assigned)
A2 Registrant Information
See guideline.
Registrant’s Full Legal Name
Overseas applicants, provide Companies Act
reference number
Street/Physical Address (for service)
Postal Address (for communication)
Contact Name
Tel
Mobile
Email
Read “Identification Table” on page 1 of guideline before completing this footer. (Ignore ACVM Use table.)
Reg No
Trade Name
P
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Registrant or Authorised Person’s Signature
Date
A3 New Zealand Agent
Complete only if you have appointed an agent in New Zealand (This is compulsory for overseas companies.)
See guideline.
Name of Organisation/Company
Street/Physical Address (for service)
Postal Address (for communication)
Contact Name
Tel
Mobile
Email
A4 New Zealand Consultant
Complete only if a New Zealand consultant is managing the registration process for you. Note that a Letter of
Authorisation is required. See guideline.
Name of Organisation/Company
Street/Physical Address (for service)
Postal Address (for communication)
Contact Name
Tel
Mobile
Email
Reg No
Trade Name
P
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Date
A5 Product Type
See guideline.
A6 Formulation Type
See guideline.
A7 Overseas Regulatory Status
See guideline.
General Information that is Part of the Product and Manufacturing Specifications
A8 Label Information
Provide an electronic copy of the label. See guideline.
A9 Shelf Life of the Formulated Product
List the shelf life in months.
A10 Pack Sizes and Ranges
See guideline.
Reg No
Trade Name
P
ACVM Use
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Date
Part B. Product and Manufacturing Specifications-Commercially Sensitive Information
B1 Active Ingredient Manufacturer/Formulator
See guideline.
Active Ingredient
Manufacturer’s/
Formulator’s Name
Site Address
Postal Address (if different)
B2 Active Ingredient Minimum Purity and Impurities
See guideline.
Active Ingredient
Reg No
Manufacturer/Formulator
Trade Name
P
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% Minimum
Purity
Impurity and %
Registrant or Authorised Person’s Signature
Date
B3 Formulation Details
See guideline.
Ingredient Name
(Common or Chemical)
CAS
Number
Quantity
(g/kg or g/L)
Function
Specific gravity
Other information about formulation (for example, overage, isomers)
Reg No
Trade Name
P
ACVM Use
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Date
B4 Manufacturer(s)/Formulator(s) of the Formulated Product
See guideline.
Company name
Street address of manufacturing site
Manufacturing step/
Function
Provide details of the main company responsible for ‘release for supply’ of this product
Company Name
Site Address
Postal Address
(if different)
Reg No
Trade Name
P
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Date
B5 Manufacturing Process
State typical batch size or range
Provide a flowchart (either within this box or as an electronic attachment to this document) representative
of the manufacturing process from beginning of the process until release.
Reg No
Trade Name
P
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B6 Specifications of the Formulated Product
Release Specifications
See guideline.
Parameter
Range (include units if
applicable)
Method
Range (include units if
applicable)
Method
Expiry Specifications
See guideline.
Parameter
Reg No
Trade Name
P
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Date
B7 Packaging Details
See guideline.
Reg No
Trade Name
P
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B8 Distribution Process (if applicable)
Complete only if storage and/or transport require special conditions, such as refrigeration, or if there are
restrictions on who may purchase the product. See guideline.
Reg No
Trade Name
P
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B9 Biosecurity Authorisation
Complete if the product contains an ingredient(s) originating from an organism. See guideline.
Has biosecurity authorisation been granted? (put an X next to correct
answer)
NA
Yes
If Yes, provide details or name of Import Health Standard in space below
Does the product contain a viable new organism, including genetically
modified organisms (GMOs)?
If Yes, then complete box below.
No
Yes
Provide the following additional details if the product contains viable new organisms.

systematic name and strain of the bacteria, protozoa, fungi, Rickettsia, nematode or virus and the taxonomic
description of the agent, serotype, strain or mutant

common name or alternative and superseded names

composition of the unformulated material, microbiological purity, nature and identity of any culture media,
impurities and content of extraneous organisms

viability of an organism (that is, live, attenuated, killed or inactivated).
B10 HSNO Approval
HSNO status must be obtained before registration will be issued. See guideline.
Status of a Substance to the EPA under the
Hazardous Substances and New Organisms Act 1996
SOS #
EPA Approval Code: HSR
Self-determination that the trade name product is nonhazardous
Reg No
Trade Name
P
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Registrant or Authorised Person’s Signature
Date
Part C: Statement and Notices
Applicant Statement
I confirm that:

I am authorised to make this application as the registrant OR a person with legal authority to act on behalf of
the registrant noted in section A2; and

the information supplied in and with this application is truthful and accurate to the best of my knowledge; and

I understand that, if this product is registered, any change to the information provided in this application must
go through the ACVM Group’s ‘variation to registration’ process or I will be in breach of the product’s
registration conditions.
Name
Tel
Signature
Email
Date
Collection of Information
Collection of Personal Information
Pursuant to Principle 3 of the Privacy Act 1993, we advise that:

This information is being collected for the purpose of registering an agricultural chemical as a trade name product under the ACVM
Act; and

The recipient of this information, which is the agency that will collect and hold the information, is the Ministry for Primary Industries,
PO Box 2526, Wellington 6140; and

Some of the information being collected will be displayed on a public register; and

The collection of information is authorised under section 10 of the ACVM Act; and

The provision of this information is necessary in order to process this application for registration; and

The supply of this information is voluntary; and

Failure to provide the requested information is likely to result in a return of the application form to the applicant, and in accordance
with the ACVM Act, may ultimately result in a refusal to register the product; and

Under Principles 6 and 7 of the Privacy Act 1993, you have the right of access to, and correction of, any personal information which
you have provided.
Collection of Official Information
All information provided to the Ministry for Primary Industries is official information and may be subject to a request made under the
Official Information Act 1982.
If a request is made under that Act for information you have provided in this declaration, the Ministry for Primary Industries will consider any
such request, taking into account its obligations under the Official Information Act 1982 and any other applicable legislation.
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