The amendment modifies the long-standing Fertiliser Control Order (FCO), 1985, strengthening requirements related to biosafety testing, field trials, product approval, and farmer guidance before nano fertilizers can be manufactured and marketed.

The move comes as nano fertilizers ultra-small nutrient particles designed to improve nutrient use efficiency and reduce fertilizer consumption gain attention globally as a potential tool to improve crop productivity while lowering environmental impacts.

Under the new provisions, manufacturers seeking authorization for nano fertilizers must now submit bio-toxicity and safety data generated by laboratories accredited under Good Laboratory Practices (GLP) or the National Accreditation Board for Testing and Calibration Laboratories (NABL). These studies must follow guidelines issued by India's Department of Biotechnology and must accompany the application submitted to the relevant state authority when seeking authorization to manufacture or sell nano fertilizers.

The amendment also revises the duration of initial product notification. Previously valid for three years, the initial notification period for nano fertilizers has been reduced to two years. During this period, manufacturers must conduct multi-location agronomic trials across at least three agro-climatic zones covering two crops and one season each. These trials are intended to validate field performance under different growing conditions before broader commercialization.

To continue selling a product beyond the initial notification, companies will now be required to submit extensive post-notification trial data covering at least ten crops across two seasons in three agro-climatic zones, conducted by either the Indian Council of Agricultural Research (ICAR) or State Agricultural Universities (SAUs). If the manufacturer fails to submit this evidence within two years of the initial notification, the approval will lapse automatically and no extension will be granted.

The amendment also introduces a new regulatory clause, Clause 20 DA that creates a formal framework for approving nano fertilizers. Under this clause, the government may notify product specifications for nano fertilizers for a maximum validity of five years, provided the products meet general standards outlined in Schedule VII of the FCO.

Manufacturers seeking approval under this new framework must submit an application using a newly introduced Form G-5, along with detailed reports on multi-location agronomic trials, biosafety testing, toxicity analysis, and product quality assessments. These evaluations must be conducted through ICAR institutions, state agricultural universities, or NABL-accredited laboratories.

The order also introduces several operational obligations for companies manufacturing nano fertilizers. Manufacturers must provide crop-specific package-of-practice guidelines to farmers, print safety precautions and usage instructions on product labels or leaflets, and ensure that training programs are conducted for farmers on safe usage of nano fertilizers.

In addition, the package of practice must specify fertilizer application recommendations that combine 75 percent of the recommended dose of conventional fertilizers with 25 percent nano fertilizer, based on positive trial outcomes.

To strengthen quality control, the government has also mandated that each production batch must be tested by an NABL-accredited laboratory before distribution, and batch numbers must be printed clearly on containers or labels, particularly for products packaged in containers smaller than five litres.

The amendment further clarifies that regulatory approval will be granted on a product-specific basis rather than company-wide approval, meaning that each nano fertilizer formulation must undergo independent evaluation.

Manufacturers wishing to sell approved nano fertilizers in individual states must also submit biosafety, toxicity, and quality reports from accredited laboratories when applying for state-level sale permission under Clause 8 of the FCO.

India has been actively exploring nano fertilizers as part of its broader effort to improve nutrient efficiency and reduce dependence on large volumes of conventional fertilizers. The updated regulatory framework aims to ensure that emerging nano-based products meet rigorous safety and performance standards before reaching farmers.

By tightening testing requirements, mandating large-scale field validation, and introducing clearer approval procedures, the government is attempting to balance innovation in fertilizer technology with stronger regulatory oversight as nano fertilizers begin to enter mainstream agricultural use.

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