ARTICLE
30 August 2024

Food Safety Bulletin

KC
Khaitan & Co LLP

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The Food Safety and Standards Authority of India (FSSAI) has informed through a press release dated 17 January 2024 that in a meeting with leading flight caterers and airlines...
India Food, Drugs, Healthcare, Life Sciences

January 2024

FSSAI directs airline caterers and airlines to comply with Food Safety Regulations

The Food Safety and Standards Authority of India (FSSAI) has informed through a press release dated 17 January 2024 that in a meeting with leading flight caterers and airlines, it has acknowledged the concerns of the passengers regarding lack of easily available information regarding in-flight food.

To effectively address the existing gap, the CEO of the FSSAI has directed all flight caterers and airlines to strictly comply with Sub-Regulation 5(10) (f) and 8(4) of the Food Safety and Standards (Labelling and Display) Regulations, 2020. These provisions would mandate the airline caterers and airlines to declare the date and time of manufacture on packed meals, as well as information pertaining to allergen, veg/non-veg logo etc. The FSSAI has further emphasised the need to address consumer grievances swiftly, and the need for robust resolution mechanism, corrective and preventive measures to minimise food safety incidents. These directions aim to improve transparency by providing passengers with detailed information about the nature, origin and manufacturing-related details of the food served during flights.

FSSAI uncovers stockpile of expired beer, takes swift action against violation of Food Safety and Standards Act, 2006 (FSSA)

The FSSAI, through a press release dated 18 January 2024 informed that it has conducted a joint inspection with the Customs Authority on 11 January 2024 at a public bonded warehouse. A Food Business Operator (FBO) was found storing 45 metric tonnes of expired beer from a popular brand, valued at INR 1 crore, in clear violation of the Food Safety and Standards Act, 2006. FSSAI has seized all expired products for further inspection. A detailed investigation is being conducted in accordance with the regulatory framework to take necessary punitive measures. FSSAI's timely intervention further emphasises its commitment to take adequate measures to ensure consumer safety and to hold FBOs, who violate food safety law, liable.

FSSAI engages in discussion with tea growers and planters in Assam to ensure safety and quality of tea production

To promote safe agricultural practices and to eliminate the usage of unauthorised pesticides in tea cultivation, the CEO of FSSAI addressed tea Growers and tea planters in Assam, as informed through a press release dated 19 January 2024.

The interactive discussion sessions centered around enhancing traceability and testing measures for raw materials, examining every batch of tea for pesticide residues and ensuring adherence to the Maximum Residue Limits (MRL) under the Food Safety and Standards Regulations, 2011. Collaboration with the Tea Board for joint inspection, sampling and testing was encouraged too. Measures such as usage of rapid testing kits were suggested to streamline effective pesticide testing. To further aid the battle against pesticide, FSSAI sought to continue extending financial assistance to Assam for upgrading laboratories used for pesticide testing. Such active collaboration between all stakeholders aims to promote safe, sustainable and quality driven tea production in the country.

February 2024

FSSAI adopts new approach to the usage of the term “ORS” in food products

The Office of the Comptroller General of Patents Designs and Trade Marks (CGPDTM) has allowed the FBOs to use the term “ORS” in their food package, in line with Section 17 of the Trade Marks Act, 1999. In such a backdrop, through an order dated 2 February 2024, the FSSAI has allowed the FBOs having valid trademarks for product names similar to 'ORS' to manufacture such products under their respective Trademark names by using the word “ORS” along with other prefix or suffix” as a whole.

All such FBOs has to provide a prominent declaration on their front of pack that “The product is NOT an ORS formula as recommended by WHO”, or likewise, to avoid confusing the consumers. The size of the font in the disclaimer must be at least 1.5mm for areas up to 100sqcm, 2mm for areas between 100-200sqcm, and 3mm for areas larger than 200sqcm. Further, a disclaimer on the front of the pack of the product i.e. “This is only a brand name or trademark of fancy name and does not represent its true nature” has to be mentioned in compliance with Regulation 4(7) of the FSS (Advertising and Claims) Regulations, 2018. FBOs are required to comply with the order w.e.f. from 1 April 2024. This order is aimed at eliminating consumer confusion and false and misleading information regarding the benefits of ORS.

FSSAI approves key amendments in its 43rd meeting

To facilitate ease of doing business, the FSSAI, in its 43rd meeting chaired by Union Health Secretary Apurva Chandra, has approved certain key amendments, as informed in a press release dated 5 February 2024. The amendments are aimed at simplifying food safety regulations under the concept of 'One Nation, One Commodity, One Regulator'.

These amendments have eliminated the need for BIS or AGMARK certification, making FSSAI certification the sole requirement for food products. Standards of Mead (Honey wine) and Alcoholic Ready-to-drink (RTD) beverages, revision of standards of milk fat products, standards for Haleem, etc., have been approved too. Additionally, comprehensive manuals for method analysis to ensure regulatory compliance have been adopted. Removing the requirement to obtain BIS or AGMARK certification would make regulatory compliance significantly simpler ensuring ease of doing business.

FSSA overrides the Indian Penal Code 1860, barring simultaneous proceedings under both the legislations: The Supreme Court of India

The Supreme Court of India, in its judgment dated 21 February 2024, in Ram Nath v. The State of Uttar Pradesh and Others [Criminal Appeal No. 472/2012], has held that, if an accused is charged with food adulteration under the Indian Penal Code, 1860 (IPC), then prosecution under the same cannot sustain further due to the overriding power of Section 89 of the FSSA.

The accusation was that the appellant, despite not having a license to sell mustard oil, continued to do so. Further, allegations of adulteration of mustard oil, edible oil, and rice bran oil was made against the appellant. An FIR came to be lodged against the appellant under Section 272 and 273 of the IPC. The appellant filed a petition under Section 482 of the Criminal Procedure Code, 1973 (CrPC) to quash proceedings under the IPC, in view of overriding effect of the FSSA. However, the Allahabad High Court dismissed the petition. The Appellant challenged the Allahabad High Court order, where the petition filed by him under Section 482 of the CrPC was dismissed. The appellant contended that the FSSA, as a special law, would override other food-related laws. Reliance was placed on the Allahabad High Court decision in Pepsico Holding India Private Limited v. State of UP[2010 SCC OnLine All 1708] (subject matter of an appeal before the Supreme Court), where the Court held that, post the FSSA coming into effect, prosecution under the IPC cannot be sustained.

The Supreme Court perused Section 3(zz) of the FSSA, which provides the definition of “unsafe food” and noted that the concept of unsafe food under the FSSA Act is much more comprehensive than adulteration under the IPC. If an offence under Section 272 and 273 is made out, then offences under Section 59 would naturally be attracted. The court, agreeing with the appellant's arguments, held that the prosecution under the IPC cannot be carried forward because Section 89 of the FSSA gives the statute's provisions an overriding effect over any other law that pertains to food-related matters within the scope of the FSSA. Hence, the Apex Court allowed the appeal and set aside the impugned Allahabad High Court order, affirming the special character of the FSSA.

FSSAI directs Time-bound processing of applications for Licenses marked for inspections

The FSSAI has noted that Designated Officers (DO) are regularly marking license applications for pre-licensing inspection, even though such inspection is not mandatory in those cases. Such pre-licensing inspection in non-mandatory cases are leading to delay in processing license applications and grant of license.

To remedy the situation, vide advisory dated 21 February 2024, FSSAI has noted that, pre-license inspections are mandatory for certain categories like milk , meat, fish and its products, fortified rice kernels, and slaughterhouses, in view of its regulatory order dated 02 May 2022. The FSSAI has further advised the DOs to not conduct pre-license inspections for non-mandatory cases unless they can justify the reason in writing. Additionally, the FSSAI has directed that, if an inspection is not conducted within 15 days of marking, the application should be recalled for reprocessing and license shall be granted. It has further urged the authorities to monitor licensing application pendency and ensure adherence to timelines. This advisory by the FSSAI would ensure that licensing applications are not held up because of a pre-licensing inspection in non-mandatory cases.

March 2024

FSSAI issues direction to all notified laboratories regarding testing of Pesticide in Tea Samples

To curb the usage of harmful pesticides during the course of tea production, the FSSAI, vide a direction dated 4 March 2024 has issued directions to all notified laboratories to test 6 noted pesticides in tea samples. The laboratories have been instructed to test tea samples for the noted pesticides named Cypermethrin, Acephate, Imidacloprid, Acetamiprid, Dinotefuran and Fipronil in addition to the existing 20 banned pesticides and other pesticides banned for tea as per the FSS (Contaminants, Toxins and Residues) Regulations, 2011. The FSSAI has also specified a tolerance limit of 0.01 mg/kg for these 6 pesticides which the notified laboratories must adhere to while testing tea samples.

FSSAI clarifies the Food Safety Licensing Requirements for In-Flight Catering

The FSSAI has recently conducted an inspection to examine the food supply chain for providing food to in-flight passengers and found some discrepancies. To address the situation, the FSSAI has issued certain clarifications vide an advisory dated 07 March 2024. The advisory has discussed the appropriate kind of business endorsements and licensing requirements that must be followed by flight kitchen operators and in-flight food service providers like airlines to ensure compliance with the FSSAI Regulations. The advisory has also clarified that flight kitchen operators should include ''Food Services [Caterer]'' in their FSSAI License, and If they use their own vehicles to transport food, they do not need a separate ''Trade/Retail – [Transporter]'' endorsement. If not, the transporter must get a separate FSSAI license for their vehicles.

The advisory further provides that Airlines should get one FSSAI License for their Head Office and include ‘'Food Services [Caterer]'' in it. No separate licenses are needed for different states. If they sell pre-packaged food, they should add ‘'Trade/Retail – [Retailer]'' to the same license. If they are manufacturing or importing pre-packaged food under their brand, they need a manufacturing or Importer License. If they store food or conduct any food business outside the flight, they need a separate FSSAI License for those premises. The advisory also requires flight kitchen operators and in-flight food Services to adhere to the FSS (Labelling and Display) Regulations, 2020. flight operators are required to include the FSSAI License / Registration number on all receipts/invoices. Flight operators must ensure passengers know the FSSAI license number of the caterer/manufacturer and the flight operator. Packaging must include the caterer's name, FSSAI License number, date and time of packaging, and use by date and time.

The advisory has clarified that passengers should be informed about FSSAI's Food Safety Connect App for reporting any food-related complaints.

FSSAI designates Authorized Officers for Food Import Clearance

The FSSAI is required to regulate the import of food products in India to ensure food safety. To ensure that a robust mechanism is in place to ensure that only safe foods are being imported into India, FSSAI decided to review the Points of Entry notified for food import, in terms of infrastructure, volume of food being imported, testing facilities etc. In this background, the FSSAI, vide a notification (uploaded on 7 March 2024), has notified Authorised Officials (FSSAI and Customs Officials) at 155 Points of Entry, under Section 25 read with 47(5) of FSSA and Regulation 13(1) of FSS (Import) Regulations, 2017, for their respective jurisdictions.

FSSAI provides Revised List of Laboratories for Food Fortification Testing

In an attempt to ensure quality and safety of fortified rice products, the FSSAI, vide an order dated 7 March 2024, has provided a revised list of laboratories for testing micronutrients in various food fortification products. Annexure 1 lists 44 laboratories capable of testing micronutrients like Iron, Vitamin B12 and Vitamin B9 in “Fortified Rice (FR)”. Annexure 2 lists 22 laboratories for testing these micronutrients in “Fortified Rice Kernels (FRK)”. Annexure 3 lists 10 laboratories for testing micronutrients in “vitamin-mineral premix for (FRK)”. The recognition and validity of these listed laboratories are governed by FSSAI guidelines. This order supersedes a previous order issued in November 2023.

FSSAI mandates implementation of Fortified Rice Traceability Application (FoRTrace)

Recognizing the complexities in Rice Fortification which involves multiple stakeholders and challenges in transparency, quality control, and traceability, the FSSAI has taken proactive steps. Vide an order dated 8 March 2024, FSSAI has mandated that manufacturers of premix for Fortified Rice Kernels and Fortified Rice must upload lab test reports of each batch on the Food Safety Compliance System (FoSCoS) portal. This should include details of the iron source and blending ratio used.

To further streamline the process, FSSAI has integrated the Fortified Rice Traceability (FoRTrace) application within FoSCoS. This platform allows various stakeholders involved in Rice Fortification, such as premix producers, fortified rice kernel manufacturers, and sellers, to record production, raw material usage, and sales data. This integration will enhance end-to-end traceability in the rice fortification value chain. FSSAI has urged States and Union Territories to adopt the FoRTrace portal to strengthen the quality of fortified rice. They have been requested to instruct food businesses to upload relevant data and to procure only from those who comply with the traceability system. This move is expected to significantly improve the quality and traceability of fortified rice in the market.

FSSAI provides directions Revising Nutrient Limits in Infant Food Regulations

The FSSAI has recognised the need to ensure the right nutritional content in infant food products. The Food Safety and Standards (Food for Infant Nutrition) Amendment Regulations, 2022, which sets new limits for certain micronutrients, is still being finalized. Considering this, the FSSAI has issued a direction on 12 March 2024, re-operationalising the revised limits for selenium, manganese, iron, and biotin in certain infant food products.

This direction has been issued after considering feedback from stakeholders who expressed difficulties in reformulating and manufacturing infant food while adhering to the levels of manganese, selenium, biotin, and iron. This direction, ensuring re-operationalisation, would continue to implement the revised permissible levels for these micronutrients in foods like infant formula and complementary foods, as detailed in Annexure 1, from October 2023 until the regulations are officially notified. This move will help avoid any disruption in the industry and ensure that infant food products continue to meet the necessary nutritional standards.

FSSAI directs regulations for Packaged Drinking Water Standards (other than mineral water)

Maintaining the quality of packaged drinking water is crucial for public health. However, the amended Food Safety and Standards (Food Product Standards and Food Additives) Amendment Regulations, which set new limits for total dissolved solids, calcium, and magnesium, are approved but still awaiting notification. To avoid any compliance disruption, the FSSAI, vide a direction dated 12 March 2024, has re-operationalised a provision pertaining to permissible limit of Dissolved Solids, Calcuim and Magnesium. The re-operationalisation will take effect from 1 January 2024.

FSSAI notifies a List of Permitted Processing Aids in the various Food Products

Many processing aids have been approved by the Working Groups and Scientific Panels and are in the process of being notified after the approval of the Food Authority. However, considering the time consuming nature of the same, the FSSAI, vide a direction dated 14 March 2024, has issued a list of permitted processing aids for use in food products, along with their intended functions and specified maximum residue levels on a provisional basis. This list has addressed enzymes, solvents, microbial control agents and other processing aids. Further, the FSSAI has directed all the Commissioner of Food Safety and Central Licensing Authorities to not take punitive action on the FBOs in the meantime, for using any processing aids which has been permitted vide this direction.

FSSAI issues clarification on licensing of “Edible Dried Fruits/Vegetable Seeds” businesses

The FSSAI has received representations regarding categorization of “Watermelon seeds” under the Food Safety and Standards Regulation (FSSR). However, there exists no specific standard for Watermelon seeds or any other Edible dried fruits/Vegetable Seeds under the FSSR. To plug the gap, FSSAI, vide an order dated 15 March 2024, has confirmed that it will add two product names, ‘'Edible Dried Fruits/Vegetable Seeds'' under the FoSCoS for licensing Edible Dried Fruits/Vegetable seeds, as an interim measure. Food businesses have been allowed to apply under the General Manufacturing category until specific standards are notified. This move will help streamline the licensing process and provide clear guidelines for dealing with edible dried fruits/vegetable seeds.

FSSAI notifies requirement of Integrated Veterinary Health Certificate for import of Milk and Milk Product Imports into India

Due to representations from stakeholders, the implementation of an integrated veterinary health certificate, which includes both FSSAI's food safety requirements and the Department of Animal Husbandry and Dairying's (DAHD) sanitary requirements, has faced delays. To address the situation, the FSSAI, vide an order dated 19 March 2024, has extended the deadline for the implementation of this integrated certificate to 30 June 2024. Imported consignments of milk and milk products will now require this integrated certificate only if the bill of lading or health certificate issuance is after this date.

FSSAI monitors the sale of food items during festivals season

The FSSAI has noted that, during festival seasons, demand for certain food articles goes up significantly, which enables certain FBOs to sell adulterated food, coupled with poor storage and handling, leading to contamination. The FSSAI has specifically flagged food poisoning issues linked with Kuttu Atta.

To address this problem, the FSSAI, vide an order dated 21 March 2024, has instructed all State/UT Food Safety Commissioners and Regional Directors to monitor manufacturers and sellers of food items commonly consumed during festivals. It has recommended conducting frequent inspections and sampling of these products to ensure they meet standards and are safe for consumption. Further, sensitisation need of FBOs have been pointed out by the FSSAI too, to eliminate unscrupulous practices. 

FSSAI issues guidelines to check adulteration of milk and milk products like khoya, sweets etc. during festival time

The FSSAI has considered the increase of demands in Milk and Milk Products, and scope of potential adulteration and unscrupulous activities. To mitigate the risk, the FSSAI, vide an order dated 21 March 2024, has instructed all Food Safety Authorities to strictly monitor milk and milk products like khoya and sweets during the upcoming festive period through special drives. Authorities have been told to vigilantly oversee production and selling of these items by conducting frequent enforcement and deploying “Food Safety Vehicles” in major markets and known adulteration hotspots to enforce standards and assure safe consumption of festive foods. This effort by FSSAI emphasizes the importance of tackling adulteration while boosting consumer sentiments.

April 2024

FSSAI provides clarification regarding categorization of ‘‘Health Drinks / Energy Drinks'' on E- Commerce website

The FSSAI has observed that certain beverages, licensed as ‘"Proprietary Foods"' and labeled under categories like ''Dairy Based Beverage'' or ''Cereal Based Beverage Mix'', have been inaccurately listed on e-commerce platforms as ''Health Drink'' or ‘'Energy Drink''. To rectify this, FSSAI, through an advisory, has clarified the correct categorization of these beverages. According to FSSAI rules, only drinks standardized under regulations as ''Carbonated'' or ‘'Non-Carbonated Water Based Flavored Drinks'' can be labeled as ''Energy Drink'' under the FSS (Food Product Standards and Food Additives) Regulations 2011. Furthermore, ''Health Drink'' is not a defined category under the FSSA or its rules/regulations. FSSAI has instructed all FBOs to correct such miscategorized drink listings and place them accurately under the regulated classifications.

FSSAI notifies the requirement of registration of Foreign Food Manufacturing Facilities

The FSSAI, vide an order dated 10 October 2022, had mandated registration of foreign food manufacturing facilities (FFMF) producing milk and milk products, meat and meat products including poultry and fish, egg powder, infant food and nutraceuticals.

In extension of the same, the FSSAI, vide an order dated 4 April 2024 has mandated registration of such FFMFs that export these items to India. These overseas food manufacturers have to register on FSSAI's 'ReFoM' portal providing details through the competent authority of exporting countries. The order extends the deadline for registration of existing nonregistered FFMFs to 31 August 2024. After this date, only imports from registered foreign businesses will be permitted.

FSSAI's Regulatory Framework for Pesticide Residues in Spices and Herbs

The FSSAI, vide an order dated 8 April 2024 has outlined a revised methodology for establishing MRL of pesticides in spices and culinary herbs. In the absence of local data, interim MRLs has to be adopted from Codex standards. If Codex levels do not exist, limits set by major importing countries has to be used. Furthermore, a default limit of 0.1 mg/kg has been prescribed for unregistered pesticides or those without established norms. This framework allows for the regulation of pesticide residues in spices and culinary herbs using international standards as interim measures, in the absence of any local field trial data.

FSSAI provides guidelines for food businesses operating from Shared Workspaces

The FSSAI has received representation from FBOs who are operating from shared workspaces and are providing documents such as work orders/work contract with the shared workspace, while applying for licenses. To address such challenges, the FSSAI, vide an advisory dated 12 April 2024, has provided guidance for food business operators seeking licenses while operating from shared workspaces.

Valid lease, rent or other agreements with the shared workspace provider can be submitted by the FBOs as proof of occupancy alongside their authorized representative's permanent address. If the FBO already possesses certificates from other Governmental Agencies, then an additional document such as GST/PAN/TAN or CIN has to be enclosed. However, this alternative licensing pathway has been limited to office-related functions or record-keeping tasks and does not cover on-site food storage. Moreover, licensing authorities may request further clarification from applicants if food storage is suspected at the shared facility location. A self-declaration acknowledging all legal compliance responsibilities is required as part of the license application process.

FSSAI provides clarification on the requirement of document for Proof of Premises for the purpose of making licensing application through FoSCoS

The FSSAI has noticed a need for clarification regarding the documents that can be used as proof of premises for licensing applications. To provide clarification, the FSSAI, vide an advisory dated 12 April 2024, has specified the documents that can be submitted as proof of premises when applying for a new food business license via the FoSCoS portal.

 Acceptable documents include sale deed/rent agreement valid for 6 months from application, proof of address issued by government authorities, premises registration documents, property tax receipt within 1-year, valid insurance/fire certificate of premises, and utility bills not older than 3 months or any other documents issued by a government or a government nominated agency. The submitted documents must reflect the correct business operator name and details. Further, it has been clarified that the FBOs hold responsibility for obtaining NOCs/permissions from other Governmental agencies whenever required.

FSSAI clarifies with regard to display of information such as declaration of calorific value, allergen, nutritional information etc. by Food Service Establishments

The FSSAI noted that it has received representations vis-à-vis misrepresentation of “Display of Information” by licensing authorities. To address the same, the FSSAI, vide a clarification dated 12 April 2024, has outlined the requirements for displaying nutritional information under the Food Safety Standards (Labelling and Display) Regulations, 2020.

The FSSAI has mandated that outlets must display calorie and nutrition details on their menus. However, they have the flexibility to display allergen and vegetarian/non-vegetarian labels on menus or handouts. E-commerce food platforms have also been directed to facilitate the uploading and display of such information by registered businesses. Licensing authorities have been advised to comply with these provisions and ensure no unnecessary penalty for establishments making reasonable efforts to provide the required information. This clarification will guide food service establishments and licensing authorities in correctly implementing the regulations.

May 2024

FSSAI introduces option to cancel pending license modification applications on FoSCoS portal

Previously, FBOs could only have one pending modification at a time in their license or registration, leading to delays and limiting their ability to keep their details up to date. To remedy the situation, the FSSAI, vide an advisory dated 16 May 2024, has introduced a new provision on FoSCoS. This provision allows FBOs to cancel a modification application filed earlier and submit an updated application, instead of waiting for the previous one to be processed. The new provision aims to provide more flexibility to FBOs to keep their license and registration details up to date by allowing them to apply modifications as and when required.

FSSAI alerts Fruit Traders to ensure compliance with Prohibition of Calcium Carbide in Fruit Ripening

The FSSAI has identified a significant health risk associated with the use of calcium carbide for artificially ripening fruits like mangoes. To address the risk, the FSSAI, vide a press release dated 18 May 2024, has issued a stern warning to fruit traders to strictly adhere to the ban on using calcium carbide. Instead of calcium carbide, it has permitted the use of ethylene gas as an alternative ripening agent, provided it is used as per the stated guidelines. Ethylene gas can be utilized at levels up to 100 parts per million (100 μl/L), with the exact concentration varying based on the type of crop, its variety, and its stage of maturity.

FSSAI has also advised food safety departments to vigilantly enforce the ban on carbide and take stringent action against violators. The Authority aims to protect consumers by eliminating hazardous substances while encouraging standardized protocols for ripening that utilizes natural hormone ethylene to ensure uniform and safe maturity of produce.

June 2024

FSSAI directs FBOs to remove the claim of 100% Fruit Juices from the label and advertisement of fruit juices

The FSSAI has noticed that numerous FBOs have been incorrectly promoting different kinds of reconstituted fruit juices as 100% fruit juices, whereas there is no provision in the Food Safety and Standards (Advertising and Claims) Regulations, 2018, allowing such a claim.

To remedy the situation, vide an advisory dated 3 June 2024, FSSAI has directed all FBOs to remove any claims of '100% fruit juice' from labels and advertisements of reconstituted fruit juices by 01 September 2024. This is because many companies were incorrectly denoting juices as 100% fruit even when the major ingredient was water, or the labelled fruit was present in low quantities. FBOs has to clearly state if a juice is 'reconstituted' and whether nutritive sweeteners exceed 15gm/kg to be labelled as 'sweetened'. This aims to protect public health by ensuring accurate information is provided to consumers as per food safety standards.

FSSAI provides a list of Referral food laboratories for testing of fortificants

The FSSAI, vide an order dated 3 June 2024, has notified a list of referral food laboratories approved to test samples of Fortified Rice, Fortified Rice Kernel and Vitamin-Mineral Premix for Fortified Rice Kernel that fail primary testing. Annexures A, B and C of the notification provide the names of laboratories that have valid NABL accreditation to test for key fortificants like iron, folic acid and vitamin B12 in these different food items. This recent FSSAI order dated 3 June 2024 updates and supersedes the previous referral laboratory list issued in November 2023.

FSSAI issue Notice regarding FSSAI-NABL Integrated Assessment

The FSSAI, vide a notice dated 3 June 2024, has outlined directions to all notified food testing laboratories regarding mandatory accreditation under the FSSAI-NABL Integrated Assessment. Notified laboratories have been instructed to obtain this integrated accreditation before the expiry of their current NABL approval or 31 March 2024, whichever is earlier, to maintain their recognition. Those who do not apply to NABL for the assessment within three months will face administrative actions as per regulations.

FSSAI issues direction for re-operationalisation of FSS (Labelling and Display) Amendment Regulations, 2022 related to Labelling Requirements of non-retail container, minimally processed food, tolerance limit, warning statement related to pan masala etc.

The draft Food Safety and Standards (Labelling and Display) Amendment Regulations, 2022 is in the process of finalisation, but the notification of the same would take some time. To address the gap, the FSSAI, vide a direction dated 5 June 2024, has re-operationalised certain provisions of the Food Safety and Standards (Labelling and Display) Amendment Regulations, 2022, related to labelling requirements of non-retail container, minimally processed food, tolerance limit, warning statement related to pan masala etc.

Regulation 10 outlines labelling requirements for non-retail food containers. It mandates the display of specific information either on the container or an attached label. This includes the food's name, FSSAI logo and license number, date marking and storage instructions (if necessary), Lot No./Batch No./Code No., and the manufacturer or packer's name and address (including the country of origin for imports).

If a container used for food transportation cannot carry a label, the required information has to be provided in accompanying documents or other suitable means and be easily traceable to the food in the containers. The containers should also carry a statement indicating they're not meant for direct sale to consumers. For pan masala, any warning statement should be clearly readable or audible in related advertisements.

FSSAI issues direction for re-operationalisation of draft FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose and Prebiotic and Probiotic Food) Regulations, 2022

Noting that the final notification of the draft FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose and Prebiotic and Probiotic Food) Regulations, 2022 (2022 Regulations) would take some time, the FSSAI, vide a direction dated 5 June 2024, has issued direction for re-operationalisation of the certain provisions of the Regulations, superseding the FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 (2016 Regulations).

The 2022 Regulations outline the general and labelling requirements applicable to all food categories. They also provide specific requirements for certain categories, including Health Supplements, Nutraceuticals, Foods for Special Dietary Use (FSDU), Food for Special Medical Purpose, and Prebiotic and Probiotic Foods. The schedules relevant to various categories under the Regulations can be found in Annexure 2. Annexure 3 contains the list of additives and their purity criteria. The 2022 Regulations also include supplement guidelines for kids above the age of two, which is an improvement over the 2016 Regulations. The 2022 Regulations also cover new formats such as drops, gummies, chewable and mouth dissolving strips etc.

FSSAI issues direction for re-operationalisation of FSS (Licensing and Registration of Food Business) Amendment Regulations, 2021

After noting that the final notification of the amendment regulations will take some time, the FSSAI has issued a direction dated 5 June 2024, re-operationalising the FSS (Licensing and Registration of Food Business) Amendment Regulations, 2021.

While enforcement of these Regulations would commence only after the final notification, the FSSAI noted that the amendment in Sub-Regulation 2.1.9. has already come into force, which changes the fee for issuing an amended license due to modification, expansion or change in premises after grant of license, from one year license fee to INR 1,000 along with differential amount of annual fee in case of upgradation of license. Further, improvement notices under Section 32 of the FSSA can be issued to the FBOs, in case they are not following general hygienic and sanitary practices, as per Schedule 4.

FSSAI invites comments on the fraft Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2024 related to standards for ultra-pasteurization, Whey Protein Concentrate and Whey Protein Isolate, Textured soy protein, High Fructose Corn Syrup (HFCS), Saffron, Juniper berries etc

The FSSAI has sought to amend the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, by introducing the draft Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2024 (draft regulations)dated 5 June 2024, and has invited public comments and suggestions.

The draft regulations aim to enhance food product and additive standards. This includes renaming ‘"nutritive sweeteners"' as "'sweeteners'", modifying the permissible levels of alcoholic acidity in maize and ragi flour, and setting new standards for products such as flattened rice and rice flour. The proposed amendments also seek to revise standards for canned seafood, fish pickles, and edible salts. Additionally, the draft regulations addresses issues pertaining to beverages, food additives, and microbiological standards. Following the date of publication, the public has been given a sixty-day period to review and provide feedback on these proposed changes. The link for submitting online comments can be found here.

FSSAI uploads the draft Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2024 for public comment

The FSSAI has uploaded the draft Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2024 (draft regulations) on 10 June 2024, amending the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 for public comment.

The draft regulations has defined canned fishery products and their packaging requirements. These products, which include finfish, crustaceans, and molluscs, are processed to ensure sterility and packed in suitable mediums like oil or water. The raw materials used should be fresh and fit for consumption. The final product should be free from foreign materials and meet specific weight requirements. It should also comply with existing Food Safety and Standards regulations. The product should only use permitted food additives and be prepared according to the FSSA. Packaging should be rust-free, sealed, and comply with the Food Safety and Standards (Packaging) Regulations, 2018 and Food Safety and Standards (Labelling and Display) Regulations, 2020.

The draft regulations has also laid down the standard for Edible Rock Salt, Edible Black Salt, Flattened Rice & Rice Flour. The draft regulations propose changes to the definition and standards for non-alcoholic beverages, specifically carbonated water and beverages. Carbonated beverages will now refer to drinks containing water that meet the standards for Packaged Drinking Water or mineral water under the FSSA with added carbon dioxide under pressure. The term 'water' will be replaced with 'beverages' in certain contexts. A new definition for Carbonated Water is also proposed, which refers to a product with water that meets certain standards, with added carbon dioxide. The link for submitting online comments can be found here.

FSSAI issues order to use only approved test methods to analyse fortifying agents in rice kernels

The FSSAI, vide an order dated 11 June 2024, has mandated that all approved testing laboratories, which are authorized to test fortifying agents (Iron, Vitamin B9, and Vitamin B12) in Fortified Rice, Fortified Rice Kernel, and Vitamin-Mineral premix for fortified rice kernel, has to only use FSSAI-approved testing methods.

These laboratories are required to integrate these FSSAI-approved methods into their existing procedures within a four-month timeframe from the date of this order. Laboratories that do not adhere to the aforementioned instructions will be delisted or removed from the approved list of laboratories for testing fortificants such as Iron, Vitamin B9, and Vitamin B12 in Fortified Rice (FR), Fortified Rice Kernels (FRK), and Premix for FRK.

FSSAI issue directions to FBOs to prohibit sell/food recall in respect of unsafe food samples

The FSSAI, vide a direction dated 18 June 2024, has issued directions to the Commissioner of Food Safety in all states and all Regional Director of FSSAI to ensure swift removal of unsafe food from the market.

FSSAI has noted that State Food and Drug Authorities (FDAs) regularly take food samples for testing. If a primary lab report deems a sample as unsafe, FSSAI has instructed Designated Officers (DOs) or Central Licensing Authorities (CLAs) to immediately stop the FBOs from selling such unsafe products or initiate food recall. Food can be recalled in cases where the FBO files an appeal against the primary lab report and the Referral Laboratory also deems the food to be unsafe, or in cases when the FBO does not prefer an appeal under Section 46(4) of the FSSA. The FSSAI has the authority to instruct the FBOs to withdraw unsafe food from the market and carry out required actions as per the Regulation 5(3) of the Food Safety & Standards (Food Recall Procedure) Regulations, 2017, read with Section 18 of the FSSA.

FSSAI publishes draft notification of Food Safety and Standards (Alcoholic Beverages) Amendment Regulations, 2024

The FSSAI has uploaded the draft Food Safety and Standards (Alcoholic Beverages) Amendment Regulations, 2024 (draft AB regulations) dated 13 June 2024 for public comment. The draft AB regulations include an amendment to Table 2 of the Food Safety and Standards (Alcoholic Beverages) Regulations, 2018, specifically regarding the maximum limit of ethyl acetate in alcoholic beverages. The current maximum limit of ethyl acetate in alcoholic beverages is 0.2 g/l of absolute alcohol, but the proposed amendment will increase it to 3.0 g/l of absolute alcohol. The link for online comment can be found here. Comments, if any, must be made within 60 days of publication of the draft.

FSSAI issues notice seeking public comments on manuals recommended by scientific committee on methods of sampling & analysis

The FSSAI, vide notice dated 26 June 2024, has sought public comments on the manuals recommended by the scientific committee. The manuals are (a) Manual of method of Analysis of Foods- Metals & Minerals, (b) Manual of Methods of Analysis of Foods- Sweets & Confectionary including Sweetening agent.

FSSAI issues notice for inviting stakeholders' comments on the Basic Food Import Clearance Fee (BFICF)

The FSSAI, vide notice dated 27 June 2024, has sought comments from stakeholders on the Basic Food Import Clearance Fee (BFICF). BFICF has to be paid by the Importer or the Customs house agent, upon arrival of the food consignment at the port.

Initially, this BFICF is set at INR 8,400 plus applicable GST for each Bill of Entry (BoE), and this fee is revenue neutral. Under the BFICF provision, each importer has to pay a standard basic fee to FSSAI for each Bill of Entry, regardless of whether it is referred by ICEGATE for FSSAI scrutiny or not. FSSAI has stated that the BFICF will include visual inspection fee, testing fee, and other fees as determined by the Food Authority from time to time, regardless of the items/testing in the specific Bill of Entry referred to FSSAI.

Before implementing the BFICF, the FSSAI has sought comments from the stakeholders. Comments are to be submitted by 15 July 2024 and is to be sent to import@fssai.gov.in.

July 2024

FSSAI launches provision for instant issuance of license/registration for certain categories of food business

To facilitate ease of doing business, the FSSAI has introduced a provision for instant ('Tatkal') issuance of licenses/registrations for specific categories of food businesses, vide a notification dated 1 July 2024. This instant issuance applies to select types of businesses and certain food product categories, as detailed in Annexure-1.

The range of eligible businesses spans from importers to small-scale retailers and hawkers, with some restrictions on specific food categories like meat and fish. The verification process for proprietorship firms is conducted through GST and AADHAAR. For Partnership or Registered firms, verification is carried out using CIN/GST and AADHAAR. Petty FBOs are registered after verification through PAN and AADHAAR, with specific conditions applicable for different categories. Further, Applicants has to declare that they do not hold a valid license/registration for the same premises and that their license/registration has not been suspended or cancelled within the past three months. They must also upload photographs of their business unit, particularly showing the entrance/front face of the unit. These instant licenses/registrations are valid for one year and can be renewed following existing procedures. The full annual fee must be paid at the time of application.

The instant issuance scheme is initially being implemented in Assam, Delhi, Gujarat, Jammu & Kashmir, and Kerala from June 2024. Applicants can apply through the FoSCoS portal homepage, with a user manual available under the 'User Manual/Guidance Document' tab for guidance.

FSSAI approves the proposal to display nutritional information labelling of total sugar, salt and saturated fat in bold letters and bigger font size

In an attempt to empower the consumers to better understand the nutritional value of the food they are consuming, the FSSAI, vide a press release dated 6 July 2024, has communicated that it has approved a proposal to highlight nutritional information about Total Sugar, Salt, and Saturated Fat on packaged food labels using bold letters and larger font size, in the 44th meeting of the authority. The labels will need to also display the percentage (%) contribution to Recommended Dietary Allowances (RDAs) for total sugar, total saturated fat, and sodium content in bold letters.

The amendment will also help in the fight against Non-Communicable Diseases (NCDs) and promote public health. Prioritising the development of distinct and understandable labelling requirements would contribute significantly to the worldwide efforts to fight Non-Communicable Diseases (NCDs).

FSSAI introduces new Kind of Business (KoB) for Direct Sellers in FoSCoS

Through earlier orders dated 8 July 2019 and 19 September 2019, the FSSAI gave exemptions to direct sellers from registration, where the main entity took up the responsibility of compliance with the Regulations. However, in other cases, direct sellers were required to obtain registration under the “Retailer” KoB, as per their eligibility. Subsequently, the FSSAI received representations from stakeholders, considering which, it noted that model of direct sellers and traditional retail businesses are different. Keeping this in mind, vide a notification dated 16 July 2024, the FSSAI has introduced a new KoB for Direct Sellers under FoSCoS.

The notification defines direct seller as an individual who, through a legally enforceable written contract, is appointed or authorized directly or indirectly by a Direct Selling Entity. These individuals conduct direct selling activities on a principal-to-principal basis, in accordance with the Consumer Protection Act, 2019 and the Direct Selling Rules, 2021, including any subsequent amendments. The eligibility criteria for different licenses are based on the annual turnover of the business. Businesses with an annual turnover up to INR 12 Lakhs are eligible for registration. Those with an annual turnover exceeding INR 12 Lakhs but not more than INR 20 Crore are eligible for a state license. Businesses with an annual turnover above INR 20 Crore are required to obtain a central license.

The food categories that are allowed are Fats, oils, and their emulsions, Bakery products, Salts, spices, soups, sauces, salads, and protein products etc.

The documentation required for registration and licensing includes two documents (a photograph and a government ID) for registration. For licensing, five documents are required as per the FSSAI order dated 19 March 2021. In addition, direct sellers are obligated to provide a copy of their agreement with the direct selling entity.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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