Agri Min issues draft rules for registration of bio-stimulants

New Delhi The agriculture ministry has come out with draft guidelines specifying efficacy data and trial reports required for registration of various categories of bio-stimulants under Schedule-VI of the FCO Amendment order 2021.

It is mandatory for a person who wants to manufacture or import any bio-stimulant to list such bio-stimulant under Schedule VI of the Fertiliser (inorganic, organic or mixed) Control Amendment Order 2021, also called the FCO Amendment order. India is one of the few countries to define separate regulations for bio-stimulants. In 2021, the government notified bio-stimulant regulation through the FCO Amendment Order. As per this order, bio-stimulants will have to be first registered and prove efficacy before hitting the market.

As per the draft guidelines for registration of bio-stimulants released on June 12, stakeholders should ensure that the data submitted along with the application for registration is authentic, replicable, utilizable and of good quality. The complete study reports should be submitted.

The requirement for registration usually includes data and information on proposed application; data on identity of the bio-stimulants (identity, composition, analysis and quality); data to assess risk to humans and the environment; data to assess efficacy of the product; its packaging (as per the material used by the applicant) and labelling requirements (contents to be defined from time to time).

Manufacturers are also required to submit the data on chemistry, bio-efficacy trials, and toxicity. Trials are necessary for each of the product for its registration.