Indian Government Tightens Regulations for Biostimulants in Agriculture

The Government of India has taken a step towards ensuring the quality and safety of biostimulants used in agriculture. A new amendment, the Fertiliser (Inorganic, Organic or Mixed) (Control) (Third) Amendment Order, 2024, establishes a stricter regulatory framework for these emerging agricultural products.

Key Changes in the Amendment:

• In Clause 20 C, relating to Specifications in respect of Biostimulants, the term ‘tracer elements’ is added along with active ingredient.

• The new category, ‘Live micro-organisms excluding biofertilizers and biopesticides’ has been added to Schedule VI. The addition of this new category by the Ministry is a positive step for companies in this field. It paves the way for clearer regulations, increased market potential, and ultimately the development of beneficial products for Indian agriculture.

• Toxicity Testing: To support their claims, manufacturers can submit not only the name of the testing institute but also details of the relevant report or publication. Acute and ecotoxicity tests are required, with exemptions for specific categories such as protein hydrolysates and seaweed extracts. Only the manufacturer/importer should submit an affidavit to the effect that their product is non-toxic and shall be safely used as biostimulants.

• Stricter Testing: Manufacturers will need to submit detailed data on the product's composition, effectiveness on crops (bio-efficacy), and potential risks to the environment and human health (toxicity). As more data becomes available on a biostimulant's chemistry effectiveness on crops (bio-efficacy), it may be grouped with similar products and potentially exempted from some testing requirements for specific crops.

• Focus on Safety: The amendment raises the permissible limit for pesticide residues in biostimulants from 0.01 ppm to 1 ppm. It also exempts certain low-risk categories from submitting full toxicity data.

• Manufacturing/Import Restriction: Only approved biostimulants listed in Schedule VI can be manufactured or imported.

Impact:

This amendment is expected to:

• Increase farmer confidence in the quality and safety of biostimulants.

• Encourage the responsible development and marketing of effective biostimulant products.

• Streamline the regulatory environment for manufacturers and importers of biostimulants.

The increased focus on safety and efficacy testing may initially slow the introduction of new biostimulants. However, it is expected to benefit farmers in the long run by ensuring access to reliable and effective products that can improve their agricultural productivity These changes aim to ensure the safety, quality and efficacy of biostimulants used in Indian agriculture.

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