Home > Compliance requirements for FRK Manufacturers

Here are the compliance requirements in India for manufacturers of Fortified Rice Kernels (FRK), premix for FRK, and associated equipment, as of recent regulations/orders.

Key Regulatory Frameworks:

1. FSSAI (Food Safety and Standards Authority of India) — under the Food Safety and Standards Act, 2006; its regulations, rules and orders.
2. BIS (Bureau of Indian Standards) — especially standards relevant to FRK, fortified rice, premix, and equipment.
3. Standard Operating Procedures (SoP) under the Ministry of Consumer Affairs / Food & Public Distribution.

Major Compliance Obligations for FRK Manufacturers:

Here are the main requirements FRK / premix / equipment manufacturers must comply with:

License / Registration: All FRK manufacturers and premix-for-FRK manufacturers must hold an FSSAI License (Central or State). Registration certificates are no longer sufficient or new registrations will not be granted for FRK / premix. Existing FBOs with Registration Certificates had a transition period of three months to shift to License status.

Testing & Quality Control: Every batch of FRK and premix must be tested for required parameters under the Food Safety & Standards Regulations. The test must be done through FSSAI-notified laboratories. A Certificate of Analysis (CoA) should be obtained (from third-party, NABL-accredited labs) for premix and finished FRK. Test reports for each batch must be uploaded on the FoSCoS portal. Also, a self-declaration is required with details such as source of iron used and blending ratio.

Traceability: FRK / premix raw materials should be procured only from FSSAI-licensed vendors, along with lab reports from FSSAI-notified labs. Full batch-wise record-keeping: production, raw material usage, sales etc. Use of FoRTrace application integrated with FoSCoS to enable traceability for FRK / premix / fortified rice.

Standards (Product, Equipment, Premix): FRK, fortified rice, and premix have to meet nutritional, physical, microbiological, packaging standards laid by BIS / FSSAI. For example: BIS standard IS 17782:2021 for FRK specification. Equipment used for manufacturing FRK must comply with IS 17853:2022 (specification for equipment for manufacturing FRK). Premix raw materials (vitamin & mineral salts) must comply with permitted sources, stored properly, etc.

Good Manufacturing Practices, Hygiene, and Safety Systems: GMP, GHP (Good Hygiene Practices), Hazard Analysis and Critical Control Points (HACCP), Quality Management Systems (e.g. ISO 22000) are expected. Clean storage, controlled moisture, avoid contamination etc.

Sampling & Audits: FSSAI has guidelines for sampling of FRK, fortified rice, and VMP (Vitamin Mineral Premix). (aifpa.net) * Occasional third‑party audits proposed/required by authorities (e.g. NIFTEM) to assess compliance on QC, hygiene, GMP etc.

Packaging, Labelling, Logo: Comply with labelling requirements under FSSAI labelling regulations. Use of the +F logo on packaging of fortified rice; FRK packaging / labelling per applicable standards.

Shelf-life & Storage: FRK should have a shelf life of minimum 12 months when delivered under the scheme. Storage conditions: moisture, temperature control, hygienic conditions.

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