South Africa regulates both biopesticides and biostimulants under the Fertilizers, Farm Feeds, Seeds and Remedies Act 36 of 1947, which was amended in 2015 to include biopesticides and in 2019 to include biostimulants. The competent authority for registration is the Department of Agriculture, Forestry and Fisheries (now the Directorate of Agricultural Inputs Control for biopesticides).

Registration can be held by a legal entity or local distributor, and the process is conducted in English.

Local efficacy trials are required for both product types. The time to approval is up to 20 months for biostimulants, with a validity period of 3 years, with the possibility of renewal.

The core South African law that governs the registration, importation, manufacturing, sale and use of biostimulants when they are marketed as agricultural products is the **Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act (Act 36 of 1947)**. It was amended in 2019 to include biostimulants. These are comprised in “group 3 fertilisers”. This core legislation establishes regulatory controls for registration, importation, manufacture, sale, labeling and sterilization of agricultural inputs in the Union of South Africa. It defines key terms, mandates registration and inspection, prescribes conditions for packaging and invoicing, and authorizes penalties for noncompliance.

Group 3 Fertilizers are defined as natural or synthetic substances or organisms that improve plant growth, yield, or soil condition, including biofertilizers, biostimulants, seaweed, organic acids, and moisture absorption products, but excluding agricultural remedies with pesticidal claims.

Biostimulant products need registration/authorisation prior to marketing. The registration holder can be a legal entity or a local distributer. The registration process is handled in English.

Registration requirements comprise a dossier with product analysis, efficacy trials on representative crops and statistical validity at 95% confidence, safety data, as well as a scientific report by a registered professional. Efficacy data for one crop in a grouping can support claims for the whole group, but a minimum of three trials is needed; extrapolation for unlisted crops requires motivation and supporting data.

In case you have a biostimulant containing microorganisms, you are required to provide microbial identification via gene sequencing, risk assessment, proof of culture deposit, quality control, shelf life studies (minimum 6 months), and quantification of colony forming units (CFU) per organism. In addition, and not to a great surprise, microbial products must meet strict contamination thresholds (\<10^5 CFU/g or mL for most contaminants), be free of human pathogens (e.g., E. coli, Salmonella), and provide certificates of analysis for harmful elements.

Labelling requirements comprise concentration, main ingredient, viable unit counts (CFU, spores, etc.), genus and species of microbes, shelf life, and comply with SANS 1268 and fertilizer regulations.

Furthermore, in case of microbial products, there are other permits required, such as concerning import (in case the microorganisms are not present in South Africa), and what they call a permit for “mass release”, with additional documentation for imported or locally manufactured organisms and notification of production facilities.

The Competent Authority is the Department of Agriculture, Forestry and Fisheries (www.daff.gov.za).

Need help? Just reach out to us. Your target is our mission !

Next in line: Turkey

We wish you a great day,

The sciBASICS Team.