This bi-monthly newsletter updates readers on recent developments in food and metrology laws, highlighting key compliance requirements across industries. In this newsletter, we cover significant developments, including the introduction of a new business category for Direct Sellers under FoSCoS, re-operationalization of licensing regulations, and updates on standards for packaged drinking water. We also delve into FSSAI's latest projects addressing microplastic contamination, amendments to fortification regulations, and new initiatives for safeguarding food safety during the festive season. Each of these updates is crucial for food business operators to ensure compliance and stay informed on evolving standards.

1) Introduction of New Business Category for ‘Direct Sellers’ Under FoSCoS:

The Food Safety and Standards Authority of India (“FSSAI”) has introduced a new business category, i.e., Kind of Business ("KoB”) for the ‘Direct Sellers’ under the Food Safety Compliance System (“FoSCoS”), vide its notification dated July 16 2024.

The purpose of introducing a new category is to distinguish Direct Sellers from Retailers and establish specific guidelines for those engaged in direct selling activities.

A ‘Direct Seller’ is defined as an individual authorized by a Direct Selling Entity through a legally binding contract to operate independently on a principal-to-principal basis, as outlined in the Consumer Protection Act 2019 /the Direct Selling Rules 2021.

Eligibility for this new category is based on the Direct Seller's annual turnover. Those with an annual turnover of up to ₹12 lakhs must register, while those with turnovers between ₹12 lakhs and ₹20 crores must obtain a state license. Direct Sellers whose turnover exceeds ₹20 crores will require a central license.

The KoB permits the following Food Categories (FC):

a. 01: Dairy products and analogues, excluding products of food category 2.0

b. 02: Fats and oils and fat emulsions

c. 06: Cereals and cereal products derived from cereal grains, roots and tubers, pulses, legumes and pith or soft core of palm tree excluding bakery wares of food category 7.0

d. 07: Bakery products

e. 12: Salts, spices, soups, sauces, salads and protein products

f. 13: Foodstuffs intended for particular nutritional uses - Only 13.4., 13.5 and 13.6.

g. 14: Beverages, excluding dairy products

h. 15: Ready -to-eat-savories

i. 16: Prepared Foods

j. 18: Indian Sweets and Indian Snacks and Savories products

The above came into effect on July 10 2024.

2) Re-operationalization of Food Safety and Standards (Licensing and Registration of Food Business) Amendment Regulations, 2021:

The FSSAI has declared the re-operationalization of certain provisions of the Food Safety and Standards (Licensing and Registration of Food Business) Amendment Regulations, 2021.

The said regulation contains amendments to the following:

a. Section I- Licencing and Registration of E-Commerce Food Business Operator.

b. Section II- Documents to be enclosed for a new application for license to State/Central Licensing Authority for the restaurant.

c. Section III - Conditions of license for the restaurant.

d. Section IV - Part II of Schedule 4 relating to general requirements on Hygienic and sanitary practices to be followed by all food business operators for license.

e. Section V - Part IV of Schedule 4 relating to establishing a small slaughterhouse.

f. Section VI - Part V of Schedule 4 relating to good hygienic and manufacturing practices to be followed by licensing food business operators engaged in catering of food service operations.

Some of the key highlights are as follows:

1. Licensing and Registration of E-Commerce Food Business Operators(“FBOs”): The regulations introduce specific definitions for e-commerce food business models, including inventory-based and marketplace models.

Requirements: E-commerce FBOs must obtain licenses from the Central Licensing Authority and comply with all safety and quality standards.

2. Documents for New Applications: The documents required for new license applications have been updated to streamline the process for restaurants and other food businesses.

3. Conditions of License for Restaurants: Restaurants must adhere to specific conditions to maintain their licenses, ensuring compliance with food safety standards.

4. Fee and Charges: The fee structure and other charges for licensing and registration have been revised. Non-payment of fees can lead to action against the food business operator.

5. Testing and Inspection: Food businesses must implement mandatory testing and inspection protocols to ensure compliance with safety standards. The Food Authority may specify the periodicity and types of tests required.

6. Appointment of Food Safety Supervisors: FBOs are required to ensure the training of Food Safety Supervisors under the training programs of FSSAI. The Authority may also prescribe the requirements for training Food Safety Supervisor.

7. Compliance and Enforcement: The Food Authority may order periodic inspections of food businesses based on the risk associated with the food and the establishment.

8. Documentation and Records: E-commerce FBOs and other food businesses must maintain detailed records of their operations, including sourcing, storage, and distribution

The updated regulations aim to streamline the licensing and registration process, making it easier for food businesses to comply with legal requirements. By enforcing stringent testing and inspection protocols, the regulations ensure higher standards of food safety and quality. The focus on e-commerce FBOs ensures that food products sold online meet the same safety standards as those sold in physical stores, protecting consumers from substandard products.

The re-operationalized regulations will come into effect on May 11, 2024, although full enforcement will only begin once the final amendment regulations are notified in the Gazette of India. In the interim, food business operators are expected to comply with the updated standards. Non-compliant businesses may face improvement notices, encouraging them to align with the new regulations.

3) FSSAI Omits Sub-Regulation (4) Of Regulation 7 Under the Food Safety and Standards (Fortification of Foods) Regulations, 2018:

On July 19 2024, the FSSAI issued a directive regarding the omission of sub-regulation (4) of regulation 7 under the Food Safety and Standards (Fortification of Foods) Regulations, 2018. 

This regulation, notified on August 2, 2018, required that all packages of iron-fortified food products carry a label advising individuals with Thalassemia to consume such products under medical supervision and warning those with Sickle Cell Anemia against consuming them.

The Ministry of Health and Family Welfare (“MoHFW”) formed a committee chaired by the Director General of the Indian Council of Medical Research (ICMR) to review the advisory on Thalassemia and Sickle Cell Anemia. Based on the committee's recommendations, the MoHFW approved the report and sent it to the FSSAI for further action. During the 44th meeting of the Food Authority, the report was reviewed, and it was decided to omit sub-regulation (4) of regulation 7.

This decision has been implemented immediately. The removal of this labelling requirement is part of FSSAI's ongoing efforts to update food safety standards in accordance with scientific recommendations and public health needs.

4) FSSAI Re-operationalizes Standards for Packaged Drinking Water:

The FSSAI has re-operationalized the Draft Food Safety and Standards (Food Product Standards and Food Additives) Amendment Regulations, which set permissible limits for Total Dissolved Solids ("TDS"), Calcium, and Magnesium in Packaged Drinking Water (excluding Mineral Water). This directive follows previous directions issued in May 2022, with modifications in June 2022 and January 2023 and a re-operationalization in March 2024.

Although the Food Authority approved the final amendment regulations during its 42nd meeting, their official notification in the Gazette of India is still pending. To ensure FBOs can continue producing Packaged Drinking Water, FSSAI has decided to re-operationalize the relevant standards from July 1 2024.

The permissible limits are:

• TDS: 75 to 500 mg/l
• Calcium (as Ca): 10 to 75 mg/l
• Magnesium (as Mg): 5 to 30 mg/l

This directive is issued under Sections 18(2)(d) and 16(5) of the Food Safety and Standards Act, 2006, to maintain standards while the formal approval process is completed.

5) Clarification on the Use of ‘Non-standardized Ingredients’ in Fruit Juices:

On July 31, 2024, the FSSAI issued a clarification regarding the selling and marketing of fruit juices containing non-standardized ingredients.

This advisory was issued after it was brought to the knowledge of the FSSAI that a few manufacturers were adding non-standardized ingredients, 'Deionized apple juice concentrate' in their fruit juices, which is not a permitted ingredient under the Food Safety Regulations.   

FSSAI has again directed all the FBOs to seek approval for any such non-specified food items or ingredients under the Food Safety and Standards (Approval for Non-Specific Food and Food Ingredients) Regulations, 2017.

Furthermore, the FBOs are directed to ensure that the claims made on product labels and in advertisements comply with the labelling and advertising standards outlined in the Food Safety and Standards (Advertising & Claims) Regulations, 2018, and the Food Safety and Standards (Labelling & Display) Regulations, 2020.

6) Extension for pre-printed packaging material Reconstituted Fruit Juices Labelled as “100 % Fruit Juices”:

The FSSAI has extended the deadline for the use of pre-printed packaging materials for reconstituted fruit juices labelled as "100% Fruit Juices." Initially, an advisory issued on June 3, 2024, had set the deadline for August 31 2024. However, this extension allows food business operators more time to comply with the new labelling requirements.

In response to numerous stakeholder requests, the FSSAI has extended the deadline for using pre-printed packaging materials for reconstituted fruit juices labelled as “100% Fruit Juices” to December 31, 2024. Additionally, products manufactured before this new deadline can continue to be sold through all distribution channels until the end of their respective shelf lives. This extension provides food business operators additional time to comply with the updated labelling requirements.

All FBOs are required to adhere to this revised timeline.

7) FSSAI Launches Project to Tackle Microplastic Contamination in Indian Food, (18.08.24):

On August 18, 2024, the FSSAI initiated a project to address the growing concern of microplastic contamination in Indian food. Launched in New Delhi, the project, titled "Micro-and Nano-Plastics as Emerging Food Contaminants: Establishing Validated Methodologies and Understanding the Prevalence in Different Food Matrices," seeks to develop and validate methods for detecting micro and nano-plastics in food products while assessing their prevalence and exposure levels across the country.

The primary purposes of the project are to develop standard protocols for micro/nano-plastic analysis, conduct intra- and inter-laboratory comparisons, and generate critical data on microplastic exposure levels among consumers.

A recent report from the Food and Agriculture Organization (“FAO”) has revealed the presence of microplastics in common food items such as sugar and salt, underscoring the global scope of this issue. However, the report emphasizes the necessity for region-specific data to thoroughly comprehend the health implications, especially in India.

By examining the level of microplastic contamination in Indian food, this initiative aims to guide the creation of regulations and safety standards to safeguard public health. The study's results will also enhance the global understanding of microplastic contamination, highlighting Indian research as a crucial component of the international effort to tackle this environmental issue.

8) FSSAI Re-operationalizes Labelling and Display Amendment Regulations 2022 regarding non-retail containers, minimally processed food, and the warning statements related to pan masala:

The FSSAI, by exercising its powers under Section 92 of the Food Safety and Standards Act, 2006, has re-operationalized certain provisions of the Food Safety and Standards (Labelling and Display) Amendment Regulations 2022, vide its direction issued on August 30 2024.

These regulations pertain to labelling requirements for non-retail containers, minimally processed food, and the warning statements related to pan masala. The original draft regulations were first operationalized on 17th June 2022 and subsequently re-operationalized on January 6, 2023, October 17, 2023, and June 5, 2024.

The Food Authority approved the final version of the amendment regulations, excluding the tolerance limit provision, during its 43rd meeting. However, since the final notification process is still ongoing, FSSAI has decided to re-operationalize the previously mentioned provisions starting from June 5, 2024. This re-operationalization excludes the tolerance limit requirement, which sets a compliance threshold of ±20% for the declared nutrient values on food labels.

9) FSSAI Re-operationalizes Draft Regulations on Health Supplements and Nutraceuticals

The FSSAI has once again re-operationalized the provisions of the draft Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Foods) Regulations, 2022, vide its direction dated August 30 2024.

As the finalization of these draft regulations is expected to take additional time, FSSAI has decided to continue with the re-operationalization of the provisions outlined in the June 5, 2024, direction. This step will ensure that the regulatory framework remains in effect while the formal notification process continues.

The re-operationalized regulations will take effect from July 1, 2024. The directive has been issued with the approval of the Competent Authority under the powers vested by Section 18(2)(d) read with Section 16(5) of the Food Safety and Standards Act, 2006. This follows a previous direction issued on June 5, 2024, which had initially re-operationalized the draft regulations.

10) Tatkal Issuance of License and Registration Nationwide:

The FSSAI has extended the provision for the instant (Tatkal) issuance of licenses and registrations for certain categories of food businesses across India.

This instant registration provision was launched on July 1 2024; however, initially, this facility was available in selected regions, including Assam, Delhi, Gujarat, Jammu & Kashmir, and Kerala. This provision is now available nationwide, with the exception of Chandigarh, Himachal Pradesh, and Meghalaya. Implementation in these excluded states and Union Territories will occur after incorporating state-specific requirements.

The instant issuance will continue to apply to specific categories of food businesses, such as wholesalers, distributors, retailers, transporters, storage without atmospheric control, importers, food vending agencies, direct sellers, merchant-exporters, petty retailers of snacks and tea shops, and hawkers (itinerant/mobile food vendors). The process remains subject to the conditions outlined in the July 1 2024 order.

To assist food business operators, a set of Frequently Asked Questions (FAQs) on the instant license and registration provision is available on the homepage of the FoSCoS portal.

The above extension took effect on August 31, 2024.

11) FSSAI Initiates Special Drives to Combat Adulteration of Sweets, Savories, and Dairy Products During Festive Season

To ensure the safety and quality of such products, FSSAI has called for preventive measures through special surveillance and enforcement drives conducted by Food Safety Officers and Designated Officers in their respective jurisdictions.

In light of the upcoming festive season, the FSSAI has issued a directive to curb the adulteration of high-demand products such as sweets, savories, milk, and milk products like ghee, khoya, and paneer.

The initiative urges all food safety officials to maintain heightened vigilance during the festive season and conduct frequent enforcement and surveillance activities to prevent adulteration.

Additionally, where available, the Food Safety on Wheels (FSW) units are suggested to be deployed in prominent markets or in response to specific intelligence to ensure that food items adhere to established safety and quality standards.

12) Draft Amendment to Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011: 

The FSSAI has proposed draft amendments to the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. These amendments are proposed under the Authority conferred by Section 92(2)(e), read with Section 16 of the Food Safety and Standards Act, 2006. They are being published for public consultation as required under Section 92(1) of the said Act.

The draft regulation is titled as, ‘the Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2024’. The following amendments are proposed under the said new regulations:

In the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, Appendix A, under the heading “IV. Use of Food Additives in Food Products”,—

In Table 1, against the entries relating to Food Category System 1.2.1.1: Fermented milks (plain) not heat treated after fermentation, after the entry ‘No additives permitted’, the following shall be inserted, namely:—

Table 1

Dairy products and analogues, excluding products of category 2.0.

In Table 1, against the entries relating to Food Category System 1.7: Dairy-based desserts, after the food additive “TOCOPHEROLS” in column (3), and the entries relating thereto, the following shall be inserted, namely:—

Table 1
Dairy products and analogues, excluding products of category 2.0.

The said draft regulations will be taken into consideration after the expiry of the period of sixty days from the date on which copies of the Gazette containing this notification are made available to the public. These drafts were published on August 21 2024, in the gazette notification.

13) Draft Amendment to the Food Safety and Standards (Fortification of Foods) Regulations, 2018:

With prior approval from the Central Government, the Food Safety and Standards Authority of India intends to amend the Food Safety and Standards (Fortification of Foods) Regulations, 2018. This draft regulation is published under the authority granted by clause (e) of sub-section (2) of section 92 of the Food Safety and Standards Act, 2006 (34 of 2006), as required by sub-section (1) of section 92 of the same Act, for public information.

These regulations may be called the Food Safety and Standards (Fortification of Foods) Amendment Regulations, 2024.

In the Food Safety and Standards (Fortification of Foods) Regulations, 2018, the sub-regulation (4) of regulation 7 will be omitted. The said sub-regulation provides that every package of food fortified with Iron shall carry a statement: "People with Thalassemia may take under medical supervision, and persons with Sickle Cell Anaemia are advised not to consume iron-fortified food products”.

After the amendment, the requirement stipulated under sub-regulation 4 will become redundant.

14) Draft Amendment to the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011

Vide notification dated September 18 2024, notice is given to public that the draft regulations to amend the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011. The said draft amendment will be considered after the expiry of sixty days from the date on which copies of the Gazette containing this notification are published and made available to the public.

Essentially, the draft regulation proposes adding 219 additional pesticides to the list of restricted substances; it includes recommended Maximum Residue Limits (“MRL”) for each newly listed pesticides. The amendments also specify updated maximum limits for various contaminants, toxic substances, and residues that food products may contain.

Objections and or suggestions, which may be received concerning the said draft regulations before the expiry of the period so specified, will be considered by the Food Safety and Standards Authority of India.

15) The Mega Food Event:

The World Food India 2024 was organized by the Ministry of Food Processing Industries. This was 3rd edition of this mega food event, held from September 19 to 22, 2024, and concluded on September 22. The Mega Food Event was supported by nine Ministries/Departments of the Government of India, 8 associated bodies, and 26 States.

The event brought together manufacturers, producers, food processors, buyers, investors, policymakers, and global organizations, offering a comprehensive platform for collaboration across the food industry.

16) Ministry of Food Processing Industries to Address Industry’s GST Concerns with GST Council:

The Ministry of Food Processing Industries has proposed to take up the food industry’s concerns regarding Goods and Services Tax (“GST”) with the GST Council.

The aforesaid issue is discussed during the meeting held between food industry leaders and the government. During this meeting, discussion was held on key issues, including taxation, ease of doing business, and misleading advertisements and to promote the food processing sector at the state level to position India as a global food product hub.

The forum also discussed other key issues which included the MRL for chemicals, challenges under the Production-Linked Incentive (“PLI”) scheme, and concerns over the export of ‘maida’ (refined flour), as wheat exports remain banned and the issues of inverted-duty structure and aligning PLI schemes with global market realities.

17) Introduction of various schemes by the Ministry of Food Processing Industries (MoFPI):

The Minister of State for Food Processing Industries has shared certain information about the various schemes concerning the Food industry, in a recent statement to the Lok Sabha.

The Ministry of Food Processing Industries (“MoFPI”) is taking significant steps to enhance the food processing sector in India. The proposed schemes, such as the Pradhan Mantri Kisan SAMPADA Yojana (PMKSY), the Production Linked Incentive Scheme for Food Processing Industry (PLISFPI), and the Prime Minister Formalization of Micro Food Processing Enterprises (PMFME) scheme, aim to modernize infrastructure, improve supply chains, increase farmer incomes, create jobs, reduce waste, boost food processing, and enhance exports.

In addition to these schemes, MoFPI is also supporting research and development through partnerships with institutions such as the Council of Scientific & Industrial Research (CSIR) and the National Institutes of Food Technology, Entrepreneurship & Management (NIFTEM) in Kundli and Thanjavur.

Contributors to the newsletter:

• Sidhartha Srivastava, Partner
• Yasmeen Sabir, Principal Associate