Biostimulants - DTS Regulatory Consultants

There has been a lot of activity both within Australia & New Zealand and internationally regarding the use of biostimulants in crop production.

Biostimulants are generally regarded as biologically based products that when applied to either soil for crop production or to a crop directly, produce a corresponding desirable effect in that crop. They are not considered to be nutrients, pesticides or soil improvers, however often claimed to replace these products in part.

They can work directly with the plant itself, often inducing plant growth regulation, to elicit production of plant defence compounds or increase tolerance of environmental stresses. Alternatively they may work within soil by such means as competing with harmful microorganisms, and or providing a means to more easily absorb nutrients. Many biostimulants are bacterial organisms and so often called crop probiotics. Other examples include organic acids, seaweed extracts and other biological compounds.

There are three main pieces of Australian legislation that need to be considered with respect to biostimulants:
+ The Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code);
+ The Biosecurity Act 2015; and
+ The Gene Technology Act 2000

The APVMA as an independent statutory authority assesses and registers end use products in accordance with the AgVet code. The APVMA also becomes involved during the manufacture, distribution up to the point of retail sale and any adverse experiences.

As part of the registration process the APVMA ensures that all regulatory requirements relating to the active constituent, end use product or label have been complied with and that its use will be of low or acceptable risk to plant, animal or human life or endanger trade. The data demonstrating that the use of the product as per recommendations has the desired beneficial effect is reviewed as is the information contained on the label.

DTS can assist with agricultural chemical registrations, veterinary product registrations, listable products(pool products or joint health products) and label compliance.

Our team of APVMA registration consultants are able to provide advice on what data is required, review the suitability of existing data, co ordinate the generation of data and collate all the necessary information in the format required to meet regulatory submission requirements.