If you are importing or manufacturing a pesticide, veterinary medicine, or other hazardous substance for use in New Zealand, you must ensure it's approved. If it's not, apply for approval here.
How to apply
It is recommended that you contact one of our advisors as early in the application process as possible. They will help you with any questions you have during the preparation of your application. Contact us:
- by phone (within New Zealand): 0800 429 7827 (0800 HAZSUBS)
- email: HSapplications@epa.govt.nz
The application form to use depends on the type of substance that you are applying for an approval for. Download the appropriate form below and send the completed and signed application to us.
- Veterinary medicine application form (docx 406KB)
- Pesticide application form (docx 418KB)
- Hazardous substances (other than pesticides and veterinary medicines) application form (docx 390KB)
Any confidential information should accompany the application form in a 'Confidential Appendix for all hazardous substances applications' form:
For more information about the application process and the information to support your application, see below.
Note: If your substance is already approved to be imported into or manufactured in New Zealand, or if your substance does not have hazardous properties, you do not need to apply for an approval.
Data requirements for assessments of active ingredients
When we, the EPA, assess a new hazardous substance for use in New Zealand, we need information. We need to know about the physical and chemical properties, toxicological effects, the environmental fate and the ecotoxicological effects of the substance to support the decision.
We use this information to consider the benefits of using the substance and we weigh these alongside the risks and the cost.
For more information about the approach we use for evaluating the risk, cost and benefit of a hazardous substance, including technical appendices about the modelling approach:
For chemical pesticides, the following document gives our data requirements in a checklist format (mandatory and conditional requirements):
Please contact us (at HSapplications@epa.govt.nz) to check the data requirements for applications for substances other than chemical pesticides (e.g. a new veterinary medicine, pure chemical, or biological pesticide).
While gathering data to support your application, remember that new studies may not be the only way of meeting the data requirements. In some cases it may be possible to justify waiving a specific data requirement or a read across from a similar substance(s).
However, if a type of information is required by us, and it is not available, you should explain why. If you consider that a study is not needed then you must include a justification for waiving this data requirement with your application.
Guidance on using read-across data (pdf 144KB)
If you are uncertain about what information is needed for your application, please get in touch by email:
Impurities of active ingredients
The active ingredients in pesticides can contain manufacturing impurities that show additional, or more severe, toxic and/or ecotoxic properties compared to the active ingredient.
Limits for these toxicologically relevant impurities have often been established by overseas organisations, such as the Australian Pesticides and Veterinary Medicines Authority (APVMA) and/or the Joint FAO/WHO Meeting on Pesticide Specifications (JMPS).
When toxicologically relevant impurities are identified for active ingredients in pesticides, a control may be applied to the substance to limit the amount of the impurity that may be present.
In most cases these limits will be in line with those established by the APVMA or JMPS. However, we may at times set limits for other toxicologically relevant impurities where this is considered appropriate.
Components of concern (excluding active ingredients)
Our risk assessment of pesticides is primarily based on an assessment of the risks from the active ingredient. However, frequently other components in a substance may also be of potential concern.
Examples include components classified as Carcinogenic, Mutagenic or Reproductive toxicants (referred to as ‘CMR substances’), or components which have been banned for use in pesticides overseas due to human health or environmental concerns.
Controls on these components
Such substances are often subject to restrictive regulations overseas, and we also place extra controls on them, because of the potential severity of the hazards they present. This is particularly the case when the substance is expected to have wide dispersive use or where the general public are likely to be exposed to the substance.
Reformulating the substance or adding additional controls, in some cases
In some cases this has led to recommendations that an applicant reformulates the substance to eliminate the component of concern, where this is achievable.
In other cases, additional controls have been applied to the substance to manage the potential adverse effects. We will contact applicants to discuss options with them when such situations arise.
In addition to CMR substances, we may also take action over components with other hazard classifications where there are concerns over their risks to human health or the environment.
Examples of components of concern include:
- Naphthalene (CAS 91-20-3) in hydrocarbon solvents (classified as a suspected human carcinogen, 6.7B)
- The solvent 1-methyl-2-Pyrrolidinone (NMP, CAS 872-50-4) (classified as a known or presumed reproductive toxicant, 6.8A)
- Nonylphenol ethoxylates (e.g. CAS 9016-45-9) (potential PBT (persistent/bioaccumulative/toxic) and endocrine disruptor).
In all these cases it is known that alternative substances are available that can be used in their place.
If you have an existing approval containing a non-active ingredient component that is a CMR, or otherwise of concern, and you are interested in reformulating to eliminate that component, then we would encourage you to contact an EPA Advisor to discuss the possibility of making an application.
The process: Rapid Assessment applications and Full Assessment applications
Once we have received your application, we will assess the pathway and determine if your substance is eligible for rapid assessment or will undergo a full assessment.
Rapid assessment application
Each form provides you with the opportunity to identify whether you think your substance is eligible for a rapid assessment as per section 28A of the HSNO Act.
To be eligible for a hazardous substance approval by rapid assessment, a substance must meet one of the following criteria:
- It has a similar composition and similar hazardous properties to a substance that already has a HSNO approval (rapid similar).
- Its hazardous properties meet the criteria for low hazard (least degrees of hazard).
- It has been formulated so that one or more of its hazardous properties has a lesser degree of hazard than a substance that already has a HSNO approval (rapid reduced).
Please note the decision to process an application through a rapid pathway is discretionary and we will make this decision during the pathway assessment.
The statutory processing time for a rapid application is 10 working days from formal receipt of the application to when the paperwork goes to the decision maker and these applications are not publicly notified.
Full assessment application
If an application to release a hazardous substance is not eligible for rapid assessment, then it will proceed as a non-notified or notified application. If there is likely to be significant public interest in the application, it will be publicly notified. An Advisor can assist you with any questions you have during the preparation of your application, including providing advice on consultation requirements.
You will need to undertake consultation with Māori if risks of significance to Māori are identified either in your application form or by the EPA staff.
Category A, B or C applications
Hazardous substance applications are classed as category A, B or C depending on the complexity of the application and the amount of information required. The complexity of the application increases from category A to category C. For example category C applications require a comprehensive information package, involve a full quantitative risk assessment and are usually reserved for active ingredients that are new to New Zealand.
Once the application is formally received the statutory timeframes are dependant on whether the application is notified or not, with non-notified and notified applications having 30 working days and 100 working days timeframes, respectively.