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Sheila Storey

REGISTRATION REQUIREMENTS FOR BIOPRODUCTS

In the last few decades, there has been a call to move away from traditional, highly toxic agricultural inputs to safer, less toxic products. As such, there has been a greater emphasis on research into and development of biological products. This has led to a flood of new products available to producers that are often confusing to the user. Sheila Storey from Nemlab says producers have to make sure that bioproducts are registered before taking out the credit card.

Registration requirements in South Africa

In South Africa, any product used as an agricultural input must be registered for such use under Act 36 of 1947. Although both biostimulants and biopesticides are governed under the same Act, they fall under different groups and as such have different registration requirements. Biostimulants are categorised as a Group 3 fertilizer and guidelines for registration of this group were published in June 2019. Biopesticides, also known as biological remedies, are classified as agricultural remedies and guidelines for the registration of these products were published in June 2015. NB. A product can be both a biostimulant and a biopesticide. If this is the case, it should be registered as such i.e. it should have 2 registration numbers.

 These products follow the same guidelines as traditional fertilizers and pesticides however some specific guidelines apply to these products. The following paragraphs highlight the guidelines relevant to the use of the product as obtained from “Guidelines for registration of Group 3 fertilizers June 2019” and “Guidelines on the data required for registration of biological/biopesticides remedies in South Africa June 2015”.

Biostimulants

All microorganisms and metabolites contained within the product must:

  • be identified using scientifically accepted procedures.
  • be deposited in Agricultural Research Council (ARC) culture collection or reputable culture collections in South Africa.
  • contain passport data or “microbes voucher”.
  • be accompanied by an approved risk assessment indicating that the microbes that are not yet released in the South African environment are not potentially harmful to humans, plants, animals or the environment.

If the product is manufactured in South Africa, the following is required:

  • An import permit if an imported microorganism is used during the development of a product.
  • A mass release permit issued by the Directorate of Plant Health or Department of Environmental Affairs.
  • The accession number assigned to the microbe by the manufacturer of the product and the origin of the microbial culture.

If the product is imported into South Africa all valid permits must be submitted. These include

  • An import permit for trials
  • A letter giving the applicant permission for commercialization of the organism
  • A mass release permit
  • Receipt of purchase with details of microbe collections name, country, genus and species identification (with up to date nomenclature)

Bionematicides

All microorganisms and metabolites contained within the product must be identified using scientifically accepted procedures. Should include where it was isolated.

  • be deposited in Agricultural Research Council (ARC) culture collection or reputable culture collections in South Africa
  • be accompanied by an approved risk assessment indicating that the microbes that are not yet released in the South African environment are not potentially harmful to humans, plants, animals or the environment.

Other requirements include:

  • A mass release permit issued by the Directorate of Plant Health or Department of Environmental Affairs.
  • The country of origin and all valid permits if the organism is to be sourced from another country. This includes a letter from a recognised authority, giving the applicant permission for commercialization of the organism.
  • If the organism is sourced locally, details of its source such as GPS coordinates or the name of the district, farm, forest or stand is required.
  • Reports on the shelf life of the formulated product. The product should remain viable for at least six months
  • The formulation should not exceed contaminants ≥ 100,000 cfu/g or ml/or not exceed limits set by the Department of Health.
  • Any known metabolites i.e. primary/secondary must be reported.

The specific requirements for the labels of each type of product are highlighted in the infographics, download it here: Registration requirements_Bioproducts

Also, watch a video with Sheila here.

Additional reading: Know your bioproducts.

Video and pictures by Carme Naude.

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