What are inhibitors?
There is no common definition used internationally to describe inhibitors. Therefore, the Ministry for Primary Industries (MPI) has developed the following definition which is in the Order in Council (OIC) declaring compounds that could be used as inhibitors as agricultural compounds.
An inhibitor substance is defined as having the purposes of mitigating the adverse environmental, sustainability, or climate change impacts of an agricultural activity if it is:
- used or intended for use in the direct or indirect management of plants or animals, or
- to be applied to a place on or in which there are plants or animals, or
- to be applied to the feed or water of plants or animals.
For the purposes of this definition, the "inhibitor substance" is the active ingredient in the product that achieves the inhibitor effect.
ACVM Act and inhibitors
In 2021, the Government agreed after public consultation that regulatory oversight of inhibitors needed strengthening to manage residues in primary produce, risks to trade in primary produce, and food safety. The ACVM Act was considered the most appropriate regulatory regime for this.
Read about the consultation on the regulation of inhibitors used in agriculture
Substances that can be used as active ingredients in inhibitor products have been included on a list of substances declared to be agricultural compounds by OIC under the ACVM Act.
The OIC will come into effect on 18 July 2022. It provides an interim regulatory pathway for inhibitor products to get registered. This means any inhibitor product containing one or more of the substances on the OIC list can only be imported, manufactured, sold, or used if it is first authorised under the ACVM Act.
The ACVM (Exemptions and Prohibited Substances) Regulations have been amended to provide a 2-year transitional period for inhibitor products that are for sale in New Zealand at the time the OIC commences (18 July 2022). This transitional period allows a company to apply for registration of their inhibitor product within the 2-year period, while keeping their product on the market. We encourage companies to apply for registration as soon as they are ready within this period.
There are some substances that can be used as an agricultural compound for other therapeutic or animal management purposes that also act as an inhibitor. These compounds will continue to be subject to the ACVM Act and its regulations for their agricultural compound use. Where such products make an inhibitor claim, the claim will be subject to the ACVM Act and Regulations if their inhibitor substance is listed in the OIC.
What you need to do to sell your product as an inhibitor
This will depend on whether the substance in the product is listed in the OIC or not. Only those products containing substances on the OIC list will be subject to the ACVM Act and Regulations when used as an inhibitor.
Regardless of the status of the inhibitor under the ACVM Act, or whether it contains an active ingredient included on the OIC list, it may already be subject to other legislation, including the Hazardous Substances and New Organisms Act 1996 (HSNO Act). The HSNO Act is administered by Environmental Protection Authority (EPA).
Hazardous substances – Environmental Protection Authority
If you have questions relating to inhibitors and the HSNO Act, email the EPA at HS.Applications@epa.govt.nz
What you need to do if your inhibitor product does not contain a substance on the OIC list
It is the intention to make all inhibitor products subject to the ACVM Act and require registration. An amendment to the ACVM is being sought to enable this.
Inhibitor products containing substances that are not on the OIC list will continue as status quo, meaning they are not subject to the ACVM Act and its regulations when used solely as an inhibitor. If a product contains a substance used as both an agricultural compound and an inhibitor and is not on the OIC list, they will remain subject to the ACVM Act and its regulations for the agricultural compound purpose only.
Note: Inhibitor products may be subject to other legislation such as the HSNO Act, even if it is not on the OIC list.
Hazardous substances – Environmental Protection Authority
If you have questions relating to inhibitors and the HSNO Act, email the EPA at HS.Applications@epa.govt.nz
What to do if your inhibitor product contains a substance on the OIC list
If your inhibitor is on the market at the time the OIC commences (18 July 2022), then you will have 2 years to obtain registration. You can apply for registration at any time in that 2-year period. After the 2-year period, if not already registered, the product cannot be imported, manufactured, sold, or used until it is registered.
For those inhibitor products that are not on the market at the time the OIC commences, an authorisation will be required under the ACVM Act before it can be imported, manufactured, sold, or used.
The 2 main types of authorisation required are:
- registration (for sale on the market), or
- provisional registration or research approval (for conducting research trials; note that products approved by provisional registration or research approval are not permitted to be sold on the market).
If you are unsure which type of authorisation is required, email approvals@mpi.govt.nz
How to apply for an authorisation for your inhibitor product
Inhibitors will be categorised as either agricultural chemicals or veterinary medicines based on how the inhibitor will be used.
Agricultural chemical-based inhibitors: These are inhibitors applied to pasture or feed crops, or crops that may be used as animal feed. This would include the situation where animals would graze the treated crop as forage.
Veterinary medicine-based inhibitors: These are inhibitors administered directly to the animal, such as a vaccine, in-feed or in-water treatment, or bolus.
For guidance on authorisation requirements (registration and research) for an inhibitor product, see:
Agricultural chemicals: making, selling, and using
Veterinary medicines and the ACVM Act 1997
Guidance documents will cover such matters as general requirements, chemistry and manufacturing, residues, and target animal and plant safety.
If you are unsure of which category an inhibitor falls within, email approvals@mpi.govt.nz
Proving your product works (efficacy)
Efficacy information will be required to support the label claim as part of the registration process for inhibitors. This is a new area of regulation, so there are no specific efficacy guidance documents for inhibitors. However, work is underway to develop them.
Until the efficacy guidance documents have been developed, MPI's ACVM team will take a pragmatic approach to assessing efficacy information for an inhibitor. We've taken this approach with other novel products, so it is not unusual to work with new or unfamiliar data submitted to support an ACVM application. It may be beneficial for applicants to discuss this with the ACVM team before submitting an application for registration, regardless of whether they are planning or have completed efficacy trial work.
Who to contact
If you have questions about inhibitors and the ACVM Act, email approvals@mpi.govt.nz
