Release approvals

If you are importing or manufacturing a pesticide, veterinary medicine, or other hazardous substance for use in New Zealand, you will need to apply for a release approval.

If your substance is not hazardous you do not need an approval.

Approved substances

If your substance is already approved to be imported into New Zealand, you do not need to apply for an approval.

Information about how to check whether your substance already has an individual approval

Information about how to check whether your substance falls under a Group Standard

Release approval application forms

The application form you need to use depends on the substance you are applying for an approval for.

Any confidential information should accompany the application form in a 'Confidential Appendix for all hazardous substances applications' form.

Confidential Appendix for all hazardous substance applications (docx 360KB)

Data requirements for chemical pesticides containing active ingredients Plus

The requirements identify the information needed for the assessment of:

  • a new active ingredient
  • a new plant protection product containing a new active ingredient
  • for any relevant metabolites of the active ingredient

in relation to identification, physical-chemical properties, toxicological effects, environmental fate and ecotoxicological effects.

The requirements state which information is always needed, and which is only conditionally required.

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, all endpoints that are indicated as ‘required’ should be addressed and if a study is not considered to be needed then a justification for waiving this data requirement must be provided.

Guidance

We can advise you about the data requirements for your application for a new substance that contains a new active ingredient, other than a chemical pesticide, (for example a new veterinary medicine, pure chemical, or biological pesticide).

Data requirements for Hazardous Substances applications (docx 412KB)

Guidance on using read-across data (pdf 144KB)

Update: June 2019

Data requirements for chemical pesticides containing active ingredients have now been updated. Changes are highlighted in yellow throughout the document.

No significant new information is required compared to previous versions. Changes provide more accurate/specific information on what type of data is required or conditionally required on either the active ingredient or the formulation containing it.

If you are uncertain about what information is needed for your application then please get in touch.

Email: HSApplications@epa.govt.nz

Impurities of active ingredients Plus

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) Plus

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.

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.

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 Plus

You will need to download the appropriate form below and send the completed and signed application to us, along with the confidential appendix. It is recommended that you contact an Advisor at the EPA as early in the application process as possible. An Advisor can assist you with any questions you have during the preparation of your application.

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.

Read our guidance on consultation with Māori for applicants

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.