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5 August 2025

Food Safety Bulletin - February 2025

KC
Khaitan & Co LLP

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India Food, Drugs, Healthcare, Life Sciences

FSSAI Notifies Draft Labelling Amendment Regulations 2025 for Public Comments

The Food Safety and Standards Authority of India (FSSAI), vide Gazette Notification dated 17 February 2025 has issued the Draft Food Safety and Standards (Labelling and Display) Amendment Regulations, 2025, proposing important updates to labelling norms to enhance transparency and consumer awareness.

Key changes include a requirement that the percentage contribution per serving to the Recommended Dietary Allowance (RDA) for added sugar, saturated fat and sodium, be displayed in bold letters with a larger font size on nutrition labels. Additionally, all milk and milk products will need to carry a specified logo, with minimum size standards for clarity on the main display panels. For coffee-chicory mixtures, mandatory declarations must be shown prominently on the front of packs in capital letters within a rectangular box.

This draft highlights FSSAI's commitment to improving labelling requirements to protect consumer interests and encourage informed choices.

FSSAI mandates timely update of Form IX Nominee Details; Auto-Approval Enabled for Non-Form C Modifications

The FSSAI, vide order dated 18 February 2025, directed all Food Business Operators (FBOs) to ensure timely updates of Form IX nominee details, as required under Rule 2.5.2 of the Food Safety and Standards Rules, 2011. It has been observed that many FBOs fail to inform the Licensing Authority when the designated nominee leaves the organisation or changes, resulting in outdated compliance records.

Under sub-regulation 2.1.9(1) of the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011, food businesses must inform authorities about any changes in their operations. This includes updates in product categories, layout, or other license-related information. Failure to follow these rules can result in penalties under Section 58 of the Food Safety and Standards Act, 2006 (FSS Act).

To help with compliance, the FSSAI has set a new rule starting on 12 February 2025. This rule allows food businesses to change Non-Form C details, including Form IX nominee information, through the Food Safety Compliance System (FoSCoS) without needing prior approval or review from the Licensing Authority. These changes can be made at no cost.

Food businesses must ensure they follow these rules closely and keep accurate records with the Authority at all times.

FSSAI Directs Referral Laboratories to Adhere to NABL Scope for Testing Referral Samples

The FSSAI, vide order dated 25 February 2025, reiterated that as per Clause 9.1(a) of the Food Safety and Standards (Recognition and Notification of Laboratories) Regulations, 2018, all referral food laboratories must conduct testing strictly within the valid NABL-accredited scope under ISO/IEC 17025 standards and within the approved premises.

The FSSAI has emphasised that only the parameters clearly included in a laboratory's NABL accreditation will be tested in referral samples. This is to ensure compliance with regulations and quality standards. Additionally, all referral laboratories listed under Section 43(2) of the FSS Act must test only those parameters specifically stated by Designated Officers (DOs) or Authorised Officers (AOs) in Form VIA.

Laboratories must strictly follow the notified scope, and any deviation may be seen as non-compliance with FSSAI's regulations.

FSSAI Launches Holi Anti-Adulteration Drive 2025 to Ensure Food Safety and Quality

In view of the Holi festival, and the anticipated surge in demand for sweets, milk and milk products, snacks and other festive food items, the FSSAI, vide order dated 28 February 2025, has directed all States, Union Territories and Regional Offices to undertake a special enforcement drive to curb adulteration and sale of substandard products.

Under the Holi Anti-Adulteration Drive 2025, enforcement officials, including designated officers, food safety officers and central food safety officers, are instructed to carry out targeted inspections and collect samples in their areas. They should pay special attention to products like milk, ghee, khoya, paneer, sweets, snacks, edible oils, cereals and similar items. Adjustments will be based on local consumption patterns.

Authorities are also directed to use Food Safety on Wheels (FSW) mobile units and station officers at key locations, such as borders, markets and hotspots. This will help with immediate testing and enforcement when needed. The goal is to enhance surveillance and enforcement, preventing adulteration and ensuring the safety and quality of festive food products during Holi.

FSSAI Issues Revised Procedure for Approval of Rapid Food Testing Kits and Methods

The FSSAI, vide order dated 28 February 2025, has issued updated guidelines superseding its earlier notice dated 31 October 2023 regarding the approval of Rapid Analytical Food Testing (RAFT) kits, equipment and methods. Under the revised procedure, manufacturers and method developers must submit applications exclusively through the online RAFT Portal (https://raft.fssai.gov.in) along with all required validations and supporting documents.

Applications will only be accepted from commercial manufacturers, including international manufacturers or their authorised Indian subsidiaries. Validation of kits and methods is required according to national or international guidelines. This must include single laboratory validation and a collaborative ring trial involving multiple laboratories.

Incomplete applications will have up to 2 chances to provide clarifications or missing information within the given timelines. If they do not, the applications will be rejected. Each application must relate to a single kit or method and include the required processing fee. Applications for general laboratory equipment or parameters not specified under Food Safety and Standards Regulations will not be accepted.

Manufacturers must also apply for renewal of RAFT certificates through the portal at least 60 days before they expire. This directive aims to simplify and standardise the approval process for rapid food testing tools that are essential for ensuring food safety compliance. It seeks to improve the process for approving and renewing rapid food testing kits, equipment and methods through an online system.

FSSAI Issues Draft Regulations Mandating Import Certificates for Vegan Foods

Vide Gazette Notification dated 28 February 2025, the FSSAI has released the Draft Food Safety and Standards (Vegan Foods) Amendment Regulations, 2025, proposing mandatory certification requirements for imported vegan food products. Under the draft, no vegan food shall be imported into India without a certificate issued by the recognised authority of the exporting country, in the prescribed Form-I format included with the draft notification.

The amendment modifies regulation 5(3), strengthening compliance measures to ensure authenticity and safety of vegan foods entering the Indian market. Stakeholders and the public are invited to submit objections or suggestions to the CEO, FSSAI, before the regulations are finalised.

This draft regulation reflects the FSSAI's continued focus on enhancing transparency and consumer confidence in vegan food imports.

March 2025

FSSAI Directs Karnataka Authorities to Act Against Use of Plastic in Idli Preparation

Vide press release dated 1 March 2025, the FSSAI issued a directive to the Karnataka State Food Safety Department as a result of constant plastic sheet usage in the steaming of idlis in certain restaurants. The FSSAI has taken cognisance of the same and has demanded immediate reports and strict enforcement action against specific FBOs that are in violation of the food safety norms.

The FSSAI noted that continued practice as mentioned above can provide for serious health risks, largely because of chances of contamination from substances like bisphenol A (BPA) and phthalates. FSSAI CEO G. Kamala Vardhana Rao emphasised that only food-grade, safe materials should be used in food preparation processes.

FSSAI Waives Registration Fees for Anganwadi Centres and Introduces Dedicated Category Under Food Services

Vide order dated 12 March 2025, invoking powers under Section 16(5) of the FSS Act, the FSSAI has directed that all Anganwadi Centres under the Integrated Child Development Services (ICDS) scheme shall be registered under a new Kind of Business (KoB) category titled "Anganwadi [ICDS] Centres" within the food services sector.

To help deliver extra nutrition to pregnant and lactating women and children up to six years old, FSSAI has removed registration fees for both new applications and renewals by Anganwadi Centres. Registrations will last for five years, and shorter durations cannot be chosen.

The fee waiver starts from the date of the order. However, fees paid for applications already submitted and awaiting processing will not be refunded. A user manual for registration in this new category is available on the FoSCoS website.

This order has the effect to make it easier and more affordable for Anganwadi Centres to register by eliminating fees and establishing a specific business category under Food Services.

FSSAI Notifies First Amendment to Packaging Regulations Allowing Use of Recycled PET

Vide Gazette Notification dated 28 March 2025, the FSSAI has issued the Food Safety and Standards (Packaging) First Amendment Regulations, 2025. This amendment introduces measures to promote sustainable packaging solutions. It updates the Food Safety and Standards (Packaging) Regulations, 2018 by allowing the use of recycled polyethylene terephthalate (PET) for packaging, storing, carrying, and dispensing food products. However, this is only permitted if it meets the national standards and guidelines set by the Authority.

The change comes after a lengthy public consultation that began in May 2022, where feedback was gathered from stakeholders. With the amendment taking effect immediately upon publication in the Official Gazette, food businesses must adapt to these new requirements to stay compliant.

This initiative shows FSSAI's dedication to ensuring food safety while supporting environmentally friendly packaging practices in India's food industry.

April 2025

FSSAI Reclassifies Food Grade Packaging as Critical in Inspection Checklists

Vide an order dated 3 April 2025, the FSSAI has issued an order that reclassifies food grade packaging material from non-critical to critical on inspection checklists for various food businesses. This includes general manufacturing, dairy, meat, fish and catering operations.

Effective immediately, the revised checklists state that all packaging materials that come into contact with food must be food grade, in good condition and come with a Certificate of Conformity from a NABL-accredited laboratory, as required by the FSS Packaging Regulations. The scoring for this compliance requirement has increased from 2 to 4 points, highlighting its greater significance in ensuring food safety.

Other checklist provisions remain the same, and the updates have been added to the FoSCoS system. This directive is issued under Section 16(5) of the FSS Act.

Supreme Court Pushes FSSAI for Timely Action on Front-of-Pack Labels

Vide order dated 9 April 2025, the Supreme Court of India disposed a public interest litigation filed by 3S and Our Health Society. The case aimed to require clear Front-of-Pack Warning Labels (FOPNL) on packaged food products that show sugar, salt and saturated fat content. The FSSAI reported that a draft amendment for the Indian Nutrition Rating (INR) system was introduced in September 2022, receiving over 14,000 comments from stakeholders. An Expert Committee was formed to review the feedback and make recommendations. The Court instructed the Expert Committee to complete its report within 3 months. This would allow the necessary regulatory changes to be made. The Court set a date for compliance afterward.

May 2025

FSSAI Directs Vigilance Against Use of Unauthorized Ripening Agents in Fruits

In an order dated 16 May 2025, FSSAI has instructed all State Food Safety Commissioners and Regional Directors to step up inspections and enforcement against the illegal use of unauthorized ripening agents, such as calcium carbide and ethephon solution, in fresh fruits. This is particularly crucial for mangoes, bananas, and papayas. Calcium carbide, commonly referred to as "masala," is banned under Regulation 2.3.5 of the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011. Despite this ban, it is still widely misused, which poses serious health risks, including cancer.

The order emphasizes the need for greater vigilance in fruit markets, mandis, and storage areas. It mandates the use of strip paper tests to detect acetylene and calls for the prosecution of violators under Section 59, along with other relevant provisions of the FSS Act. FSSAI also reminded that ethephon can only be used indirectly, following the prescribed procedures. The agency warned against the use of synthetic colors and non-permitted wax coatings.

The order shall have an effect of protecting consumer health by reducing the use of illegal chemicals and unsafe practices in fruit ripening and handling.

FSSAI Mandates Closure Reports for Expired Licenses and Registrations

FSSAI, vide order dated 16 May 2025, has directed all Food Business Operators (FBOs) whose FSSAI License or Registration expired during FY 2024-25 to file a mandatory Closure Report. This report must confirm either the end of food business activities under the expired license or registration, or detail whether a new license or registration has been obtained. FBOs must also explain the reasons for not renewing.

In the future, submitting this information through the Food Safety Compliance System (FoSCoS) portal will be required immediately upon expiry in all cases. This change aims to improve transparency and traceability. Operating a food business with an expired license is a violation of Section 31 of the FSS Act. It can lead to penalties of up to RIO lakhs under Section 63. FBOs should make sure their contact details on FoSCoS are up to date. A user manual has been shared to help with submissions.

FSSAI Implements Agreement with Bhutan for Mutual Recognition of Food Safety Certification

FSSAI, vide office order dated 19 May 2025 has announced the start of an Agreement signed on 21 March 2024 between the Ministry of Health and Family Welfare, Government of India (through FSSAI), and the Bhutan Food and Drug Authority (BFDA), Ministry of Health, Royal Government of Bhutan. This Agreement recognizes the official controls that BFDA exercises over Bhutanese Food Business Operators as equivalent to the requirements of FSSAI. From now on, food shipments imported into India from approved Bhutanese establishments will be eligible for clearance if they are accompanied by a Health Certificate issued by BFDA's competent authority. The order includes sample certificates, details of authorized signatories, and a revised list of 117 approved establishments. All customs and FSSAI officials have been instructed to grant NOCs for compliant shipments based on these certificates. The intention behind the order is to simplify cross-border food trade with Bhutan by accepting BFDA-issued health certificates for imports into India.

FSSAI Consults Stakeholders on Fixed Renewal Cycles and Extended Validity for Licenses

Vide a notice dated 20 May 2025, FSSAI has released a Consultation Paper suggesting changes to the licensing system under sub-regulation 2.1.7 of the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011.

Right now, Food Business Operators (FBOs) can choose a license validity that ranges from 1 to 5 years. This choice creates different expiry dates and can lead to administrative challenges, especially for operators managing multiple units in different States and Union Territories. To address this issue, FSSAI has proposed two options based on feedback from stakeholders. First, Food Business Operators (FBOs) could choose a renewal date that works for them. Second, FSSAI may consider offering a longer license validity, up to 10 years, for certain categories under the Trade/Retail head. Stakeholders can submit their comments and suggestions within 30 days using the provided Google Form link.

The notice seeks to improve convenience, regulatory clarity, and administrative efficiency by introducing uniform renewal cycles and longer validity periods for FSSAI licenses.

FSSAI Prohibits Misleading Use of "100%" on Food Labels and Promotional Content

The FSSAI, vide an advisory dated 28 May, 2025, directed all Food Business Operators (FBOs) to stop using the term "100%" on food product labels, packaging, and promotional materials. Despite its growing popularity, the FSS Act and its accompanying rules and regulations do not define the term. Its use has been discovered to be unclear and deceptive, which could give customers a distorted sense of superiority or purity over rival goods. The Food Safety and Standards (Advertising and Claims) Regulations, 2018's Regulations 10(7) and 4(1) are cited in the directive. These regulations stipulate that claims must be accurate, clear, and non-misleading, and they must not disparage other manufacturers.

June 2025

FSSAI Extends Validity of NOC for Imported Alcoholic Beverages Bottled in Origin and in Bulk

Vide order dated 13 June 2025, invoking powers under Regulation 14(2) of the Food Safety and Standards (Import) Regulations, 2017, FSSAI has granted validity period of 365 days to the No Objection Certificate (NOC) issued for imported consignments of alcoholic drinks (bottled in origin or in bulk) with over 10% alcohol content and without date of expiration.

For consignments in the customs areas of the ports beyond this 365-day period, importers can apply for visual inspection for revalidation upon payment of the stipulated fee. The move is aimed at ensuring ease of doing business in the importation of alcohol while ensuring food safety regulation. The order overrides all earlier instructions issued on this issue.

FSSAI Notifies Comprehensive Amendments to Alcoholic Beverages Regulations, 2025

Vide Gazette Notification dated 23 June 2025, FSSAI announced the Food Safety and Standards (Alcoholic Beverages) First Amendment Regulations, 2025. These changes update and expand the rules governing alcoholic products under the FSS Act. They will come into effect on 1 January 2026.

The amendment broadens the scope of the 2018 regulations by introducing official definitions and standards for various types of beverages. It defines Ready-to-Drink (RTD) Alcoholic Beverages for the first time. These include flavoured drinks with an alcohol content between 0.5% and 15% by volume (ABV). These products are made with either spirits or mixed alcoholic bases and may include allowed flavours, additives, juices, or spices. The amendment also clarifies that carbonated RTD beverages must meet the updated CO₂ standards laid out in a revised Table-4, which is now called Requirements for Alcoholic RTD Beverages, which lays out the new ABV range.

The revisions in regulations also includes a revision to Regulation 2.2, which now classifies Indian or Country Liquors into two categories: Plain and Blended. This provides clearer legal recognition and quality standards for traditional Indian spirits. The amendment includes Honey Wine (Mead) and Nitro Craft Beer in the statutory standards, ensuring their growing presence in the Indian market does not go unnoticed.

Overall, this regulatory update represents a policy change aimed at improving the legal framework for alcoholic beverages in India.

The content of this document does not necessarily reflect the views / position of Khaitan & Co but remain solely those of the author(s). For any further queries or follow up, please contact Khaitan & Co at editors@khaitanco.com.

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