Biostimulants

There has been significant regulatory and commercial attention in both Australia and New Zealand, as well as internationally, regarding the use of biostimulants in crop production

Products for Plant Growth

Biostimulants are nature-based products that enhance a plant’s inherent growth and resilience, distinct from traditional fertilizers or pesticides

Biostimulants are generally understood to be biologically based products which, when applied to soil or directly to crops, produce a beneficial effect on plant growth or resilience. They are distinct from nutrients, pesticides, or traditional soil conditioners, although claims are often made that they can partially substitute for these product categories.

Mode of action can vary: Biostimulants may act directly on plants by influencing growth regulation, stimulating the production of defence compounds, or improving tolerance to environmental stresses. Others act in the soil by competing with harmful microorganisms or enhancing the plant’s ability to access and absorb nutrients. Some biostimulants are microbial in nature and may be referred to as crop probiotics, while others include organic acids, seaweed extracts, or other natural or biological compounds.

Regulatory context in Australia

Three key legislative instruments regulate biostimulants in Australia:

Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code)
Biosecurity Act 2015
Gene Technology Act 2000

The Australian Pesticides and Veterinary Medicines Authority (APVMA), an independent statutory body, assesses and registers end-use agricultural and veterinary products under the Agvet Code. Regulatory oversight spans manufacture, distribution, retail sale, and post-market monitoring, including adverse experience reporting.

As part of the registration process, the APVMA ensures compliance with regulatory requirements relating to the active constituent, formulation, and labelling. Importantly, it requires that the product’s proposed use presents low or acceptable risk to human, animal, and plant health, while safeguarding trade. Scientific data must demonstrate that the claimed beneficial effects occur when the product is used as directed, and all labelling information must meet statutory standards.

Regulatory context in New Zealand

Hazardous Substances and New Organisms Act 1996 (HSNO), administered by the Environmental Protection Authority (EPA);
Agricultural Compounds and Veterinary Medicines Act 1997 (ACVM Act), administered by the Ministry for Primary Industries (MPI); and
Biosecurity Act 1993 for the import and release of biological materials.

In New Zealand, biostimulants are not subject to a single dedicated regulatory framework, but are regulated depending on product classification. Factors considered include whether a product is deemed a fertiliser, a plant growth regulator, or a biological agricultural compound.

Products that exert a growth regulatory effect may fall under the ACVM Act and require MPI approval before being imported, manufactured, or sold. Depending on composition, biostimulants containing living organisms or genetically modified components may also require an EPA HSNO assessment.

How ANZ Reg consultants can assist?

ANZ Reg provides consultancy support for regulatory submissions in both Australia and New Zealand. Our team of APVMA and ACVM regulatory specialists can:

Advise on product classification under relevant legislation;
Determine data requirements for registration;
Review the adequacy of existing study data;
Coordinate the generation of new studies (efficacy, residue, toxicology, or environmental fate); and
Prepare and submit regulatory dossiers in the required formats for APVMA or MPI/EPA evaluation.

We also assist with label compliance, agricultural and veterinary chemical registrations, listable products, and regulatory strategy to ensure timely market access.