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Bio-Stimulant Registration

We act now for future

AGROCHEMICAL & PESTICIDES Bio-Stimulant Registration

We owe this to our future generations

Bio-stimulant is a substance or microorganism or a combination of both whose primary function when applied to plants, seeds or rhizosphere is to stimulate physiological processes in plants and to enhance its nutrient uptake, growth, yield, nutrition efficiency, crop quality and tolerance to stress, regardless of its nutrient content, but does not include pesticides or plant growth regulators which are regulated under the Insecticide Act, 1968.
In India, the use of bio-stimulants is regulated by the Fertiliser (Inorganic, Organic or Mixed) (Control) Order, 1985 which was further amended by Fertilizer (Inorganic, Organic or Mixed) Control Amendment Order, 2021 issued by Ministry of Agriculture and Farmers Welfare.

Pesticides and plant growth regulators listed under the Insecticide Act, 1968 (46 of 1968) are not included as bio-stimulants.

Bio-stimulants are categorised as a fertiliser. 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. If the product is already in the Indian market, the manufacturer/importer must first obtain the provisional certificate to be able to continue in the market. After this, testing must be done to obtain the data requirements to get Permanent registration.

CATEGORIES OF BIO-STIMULANTS

UNDER SCHEDULE VI

  • Botanical extracts, including seaweed extracts
  • Bio-chemicals
  • Protein hydrolysates and amino acids
  • Vitamins
  • Cell free microbial products
  • Antioxidants
  • Antiperspirants
  • Humic and fulvic acid and their derivatives

How
Mind Sync
Can Help?

We make a real difference by combining the skills and resources of our dedicated associates, from the field to our partner laboratories and regulatory services, to deploy pertinent solutions responding to all our clients’ needs. We have well-established working relationships with many competent authorities, which means we can support you to achieve product registrations effectively and efficiently.

QUICK ANSWERS

  • Application to be made first to the State Agricultural Department;
  • The State Agricultural Department will then issue Form G2;
  • With this Form G2, product wise application to be made to “The Controller of Fertiliser” at New Delhi in Form G1;
  • The Controller of Fertiliser will then issue product wise Provisional Registration in Form G3;
  • Permanent Registration- Every manufacturer/ importer of a bio-stimulant shall make an application to The Controller of Fertiliser in Form G with the study reports for specifying it as bio-stimulant in Schedule VI.
  • Name of responsible person and his/her acceptance on stamp paper (as per clause 24 of FCO 1985) on a non-judicial stamp paper duly notarised;
  • Duly filled application in the prescribed format;
  • Last 3 Years Sale details/ GST Data for the Last 3 Years / Stock, Production, Trade of the product for last 3 years duly verified by a Chartered Accountant;
  • Label of Product(s);
  • Self-Declaration affirming that no hazardous effect has been noticed on a non-judicial stamp paper duly notarised.
  • Form G2 issued by the State Agricultural Department; Last 3 Years Sale details/ GST Data for the Last 3 Years / Stock, Production, Trade of the product for last 3 years duly verified by a Chartered Accountant;
  • Product technical specifications, chemical composition;
  • Product Label;
  • Self-Declaration affirming that no hazardous effect has been noticed on a non-judicial stamp paper duly notarised;
  • Self-Declaration affirming that the product is available in the market prior to publication of the said Order;
  • Name of responsible person and his/her acceptance on stamp paper (as per clause 24 of FCO 1985) on a non-judicial stamp paper duly notarised;
  • KYC documents of the entity and the authorised person.

Respective State Governments
Controller of Fertiliser, New Delhi

Studies required for Permanent Registration

Data Studies to be undertaken
Chemistry

Chemical analysis from a GLP/NABL accredited lab:

  • Source- natural extracts of plant/microbe/animal/synthetic;
  • Product specification- Physical and Chemical properties of active ingredients and adjuvants, (if any);
  • Shelf-life claims;
  • Method of Analysis conforming to the specifications.

Bio-efficacy & Residue
  • Agronomic Bio-efficiency trials shall be conducted at National
    Agricultural Research System, including Indian Council of
    Agricultural Research (ICAR), State Agricultural Universities;
  • Bio-efficacy trials shall be conducted for 1 season for minimum 3 different doses at 3 agro-ecological locations.
Toxicity

Acute Toxicity:

  • Acute Oral (Rat)
  • Acute Dermal (Rat)
  • Acute Inhalation (Rat)
  • Primary Skin Irritation (Rabbit)
  • Eye Irritation (Rabbit)

Ecotoxicity (Aquatic):
  • Fish Acute Toxicity Test
  • Freshwater Alga and Cyanobacteria, Growth Inhibition Test
  • Fish Embryo Acute Toxicity (FET) Test
  • Daphnia Sp. Acute Immobilisation Test
  • Daphnia magna Reproduction Test
Ecotoxicity (Terrestrial):
  • Honeybees Acute Oral Toxicity Test
  • Honeybees Acute Contact Toxicity Test
  • Earthworm Acute Toxicity Test
  • Avian Acute Oral Toxicity Test
  • Toxicity to Bird
Heavy Metal Analysis
No bio-stimulant shall contain heavy metals content over and above the following maximum limit prescribed for various metals:
  • Cadmium (as Cd),
  • Chromium (VI) (as Cr),
  • Copper (as Cu) ,
  • Zinc (as Zn),
  • Lead (as Pb),
  • Arsenic (as As2O3)
Pesticide Analysis
The sample of the product along with an Affidavit by the manufacturer/ importer on a non-judicial stamp paper of Rs.10 stating that the product is not laced with pesticide beyond the permissible limit of 0.01 ppm.

Do you have any queries?

This information is in summary form and is therefore intended for general guidance only. It is not intended to be a substitute for detailed research or the exercise of professional judgment. Mind Sync does not accept any responsibility for loss occasioned to any person acting or refraining from action as a result of any information provided herein. On any specific matter, reference should be made to the appropriate advisor.

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