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Evolution of food safety standards
Thursday, 16 September, 2021, 13 : 00 PM [IST]
Heramb Tadpatrikar
In 2015, headlines such as ‘Nestlé Withdraws Maggi Noodles in India after Food Scare' were splashed across national and international media. Indeed, initially six states and, subsequently, in June 2015, the national food safety regulator—the Food Safety and Standards Authority of India (FSSAI), banned Maggi Noodles nationwide.

The national ban was instituted after tests allegedly showed packets exceeded the legal limits for lead; additionally, FSSAI alleged that the product label falsely indicated no added monosodium glutamate (MSG). Nestlé recalled and destroyed over 25,000 tons of the product as a good will gesture but challenged FSSAI’s directive before the Bombay High Court (BHC).

The company contended that the ban orders violated principles of natural justice, that laboratories conducting the tests were not accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL), and that the Authority did not provide proper notification under the Food Safety and Standards Act, 2006 (FSSA).

Additionally, the company asserted that the test reports were unreliable because the products were tested after their expiration dates, not tested per intended use, and not sealed during the three-month testing period. On August 13, 2015, the BHC lifted the ban, directing Nestlé to prove within six weeks that the product was safe through retesting at three independent NABL accredited laboratories. Nestlé also agreed to remove ‘no added MSG' from its label.

Another issue that grabbed headlines in 2014-2015 was the impounding of imported goods as mislabelled that provided FSSAI-required information by covering global labels with stickers. There was no prior notice of this action and the use of such stickers had been standard past practice. Highly valuable consignments of chocolates, sauces, mayonnaise, edible oils, alcoholic and non-alcoholic beverages, among others, were thus stuck at the ports. Additionally, requirements frequently were imposed without consideration of the nature of the product. For example, FSSAI insisted on a list of ingredients even for single ingredient food products. While many importers re-exported their products, or withdrew from the Indian market, some approached the courts for relief.

FSSAI stance in the Maggi issue and FSSAI’s yo-yoing on product approval and labelling requirements impacted India’s investment and business environment. In the Nestlé case, it was argued that FSSAI did not provide a fair opportunity for a hearing and rectification (of the label) and that the ban was imposed in a non-transparent and arbitrary manner. Moreover, the Indian regulator failed to meet its own conditions—for example, while it mandated reports from NABL accredited labs, it relied on reports that did not fulfil these criteria.

Regarding product approval and labelling issues, companies had little choice but to seek relief from the courts. Courts have taken note of the implementation difficulties as well as the lacuna and penalties under FSSA, and have been providing relief to claimants while ordering reconsideration of the FSSA and its rules/regulations.

Indian Food Laws and Regulations
The events described above compelled the government and FSSAI to review the regulatory environment and administration of laws impacting food in India. Under India’s Constitution legislative powers are divided between the central government and the 29 states. ‘Foodstuffs including edible oil seeds and oils' and ‘Adulteration of foodstuffs and other goods' are subject to concurrent jurisdiction of Central Government and the states: Central Government passes the laws, and the states adopt and implement them. In the Maggi case discussed above, authorities in the state of Uttar Pradesh first tested and banned it, followed by five other states, and then the FSSAI banned it nationwide.

Prior to 2006, food regulation in India was governed by the Prevention of Food Adulteration Act, 1954 (PFA). FSSAI had the objective of shifting focus from just curbing food adulteration to an integrated science-based food law with a risk-based approach to food safety. FSSAI consolidated under its umbrella all older laws, rules, regulations, and orders related to food, providing food standards, and regulating and monitoring the manufacture, import, processing, distribution, and sale of food.

The Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply & Distribution) Act, 1992 (IMS ACT), Bureau of Indian Standards (BIS) requirements, the Legal Metrology Act, 2009 and Rules/Regulations thereunder and the Agricultural Produce (Grading and Marking) Amendment Act, 1986 with a risk-based approach to food safety continue to be applicable.

The implementation of the FSSA has been painfully slow and there were significant teething problems in operationalization of the FSSAI, and its Scientific Panels and Central Advisory Committee (CAC). Applications for product approval/standard setting filed under the erstwhile PFA regime were transferred to the FSSAI but were left unaddressed as the manner of assessment and rules were not in place. In 2008, FSSAI was established as an independent statutory authority under the Ministry of Health and Family Welfare (MoH). In 2011, the FSSAI Rules and six regulations were released.

The new regulatory regime raised significant concerns regarding FSSAI’s arbitrary and non-transparent procedures and frequent changes of regulatory requirements for food product approval, labeling, licensing, and import. The FSSA also lacked uniformity in implementation and harmonization with the internationally accepted Food Code standards established by the Codex Alimentarius Commission (Codex). Moreover, BIS and Legal Metrology have overlapping legal and regulatory requirements, which is a major barrier to providing an enabling environment for industry.

FSSAI is aided by the CAC, which has representatives from industry and government, ensuring close cooperation between FSSAI, enforcement agencies, and organizations operating in the field of food. The CAC also advises FSSAI on developing its work program, identifying potential risks, knowledge sharing, and other issues. The Scientific Committee provides FSSAI scientific opinions (currently there are sixteen panels on subjects such as labelling, additives, nutraceuticals, contaminants, milk products, water and beverages). FSSAI has also set up a Standards Review Panel to identify gaps in the existing Indian food standards as compared with international standards.

Key Developments
In the past year, there have been significant developments in this space. The MoH and FSSAI have aligned Indian standards with Codex. FSSAI has also attempted to transform itself into a facilitator and an enabler rather than a regulator de rigueur. The authority launched consumer outreach initiatives on diets for children with metabolic disorders, consumer empowerment mobile applications, and a food safety knowledge assimilation network, among others.

FSSAI is also partnering with organizations such as the Advertising Standards Council of India (ASCI) as well as stakeholders like the Confederation of Indian Industry (CII), Hindustan Unilever Ltd., Tata Trust, and PATH to address misleading advertisements, food fortification, and skill development. Significantly, FSSAI also established twenty-four standards and issued twenty-seven draft notifications soliciting comments from stakeholders.

1.    Standard for proprietary food and product approval
Food Safety and Standards (Approval of Non-Specified Food and Food Ingredients) Regulations, were issued for product approval for import, manufacturing, marketing, and distribution of ‘Proprietary Foods' in India. The draft includes approval based on ingredients as well as on recipes and establishes a simpler process for approvals. According to FSSAI, since 2014 premarket approval has been pending for about 2,500 products; given these regulatory changes about 90% of the product categories are now exempted from approval.

FSSAI released the standard for Proprietary Foods. However, there are some niggling concerns. First, it provides that proprietary foods may contain vitamins and minerals in quantities not exceeding one RDA of the respective micronutrients. Another major concern for industry is the prescription that “no health claims shall be made in respect of proprietary foods either on the product label or otherwise.”

2. Food additives
FSSAI finalised a list of 11,000 permissible food additives via final Gazette Notification thereby harmonizing horizontal standards for food additives used in certain food categories. Although industry welcomed the clarity these regulations provide, a few issues remain unaddressed including compliance timelines, further alignment with CODEX, and the lack of functional categories for additives.

3. Removal of zinc as a contaminant
After significant advocacy efforts from industry, zinc was removed from the list of contaminants. FSSAI recognised that zinc is a micronutrient required in small quantities for daily metabolism. The move supports nutrition in India, where micronutrient deficiency has a long history.

4. Food imports
FSSAI initiatives to facilitate trade and import of food items into the country includes increased appointments of Customs Officers, the operationalization of the Food Safety and Standards (Food Import), Regulations initiation of the Customs Single Window Interface for Facilitating Trade (SWIFT), and establishment of two committees to resolve food importer grievances.

The single omnibus draft Food Safety and Standards (Food Import), Regulations, consolidates guidelines on various aspects of food importation, such as labelling, clearance processes, restricted items, importation for tasting and exhibition, sampling, and inspection notes.

The detailed instructions on imports through SWIFT are a major change, since they replace multiple documentation and schedule requirements. The regulations also provide detailed packaging and labelling norms for imported food and a scheme for risk-based food import clearance with a special provision for post-clearance surveillance and inspection. Despite being a welcome move by FSSAI, the regulation suffers from several shortcomings, such as random checks on imported food, broad discretionary powers to Customs Officers to recommend license cancellations or suspensions, lack of timelines for inspection and sampling, and overall lack of implementation at the ground level.

5. Food for infants and children
Notification allowing supplementation of infant formula and follow-up-formula with docosahexaenoic acid (DHA) and arachidonic acid (ARA) was a hard-won victory for industry.

Comprehensive standards for infant food and complementary foods for children are also under development.

6. Nutraceuticals
Regulations for nutraceuticals in India have always been a grey area. The blurred line between drug and food supplements became apparent in 2009 when the National Pharmaceutical Pricing Authority (NPPA) opined that pharma firms were marketing drugs as food supplements to escape price controls. The question of whether health supplements are drugs or food supplements came before the Patna High Court10 and as per that court, a Sub-committee on Nutraceuticals was constituted by the Drugs Technical Advisory Board (DTAB) under MoH to analyse nutraceutical ingredients.

A few concerns have emerged with these regulations: They omitted or deleted some ingredients that have a history of safe consumption in India and the criteria for claims need to be harmonized with CODEX substantiation criteria. Moreover, prior approval may now be required for omitted nutraceuticals even where safety has been established in India or another country. This may act as an impediment to the introduction of innovative specialty food products in the country.

7. Food fortification
Food fortification is central to meeting the nutritional requirements of Indians, especially to address malnutrition in children and women. FSSAI adopted fortification standards for milk, edible oil, salt, rice, wheat flour, and flour. The regulations include standards on micronutrient content in fortified food as well as norms for quality assurance, packaging and labelling, and promotion.

FSSAI also released a Joint Declaration endorsing fortification of common foods including edible oil, milk, wheat flour, rice, and salt with vitamins and minerals. FSSAI is also likely to come up with fortification standards for packaged food products such as cereals and biscuits.

8. Foods with high fat, sugar, and salt
The report, which provided recommendations for consumers, FSSAI, and industry, addressed the critical role of food labelling as the primary interface between suppliers and consumers. FSSAI is preparing draft rules to ensure uniform display of levels of sodium, sugar, and fats, including cholesterol and trans-fat, in all packaged and processed food. FSSAI is also seeking to restrict disguised promotion of foods high in fat, salt, or sugar in schools and mass media with the help of the ASCI.

(The author is partner at Dimsum Wu)
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