As India’s processed food industry grows at a compounded 12% a year, companies are introducing a flurry of new flavours and products. Between 2012 and 2015, the industry tried to introduce nearly 4,500 products with completely new formulations.

In this two-part series, details how India’s food safety regime has failed to keep pace with the industry’s enormous expansion. The first part of the series details recent Comptroller and Auditor General’s findings on how between 2012-’16 the authorities allowed the sale of food proven to be dangerous. This second part looks at how, starting 2016, the Bharatiya Janata Party-led government has subverted food safety norms under the guise of improving ease of doing business.

When it comes to the safety of many processed food products Indians are eating, they are relying on an honour system: if manufacturers assure the government regulators that their products are safe, they will go to the market, no questions asked, without any scientific assessment of these claims.

This has been allowed under regulations that came into effect in January 2016, framed on the directions of the Prime Minister’s Office in August 2014, government records reviewed by show. The regulations were drafted by the Food Safety and Standards Authority of India, which is responsible for ensuring the food sold in the country is safe to consume. They were framed in consultation with the Union Ministry of Food Processing Industries, whose primary mandate is to promote processed food. The industry bodies such as the Federation of Indian Chambers of Commerce and Industry were consulted too.

Till the new regulations were introduced, the government had a single set of rules to regulate three kinds of foods: proprietary foods, novel products and health supplements. Proprietary foods use known ingredients in combinations that have not been tested for safety before; novel foods contain ingredients that have never been used previously; while health supplements constitute products such as multivitamins that supposedly improve health generally but do not cure any disease.

As the first part of this series showed, the Comptroller and Auditor General of India recently noted that between 2012-’16 these regulations had been diluted, bypassed and violated to allow even dangerous food products to be sold.

In 2014, the Bombay High Court scrapped the old regulations on procedural grounds – they had not been approved by Parliament and were being used merely as guidelines by the food safety authority, which kept changing them at its whim. The decision was subsequently upheld by the Supreme Court.

Business friendly steps

Instead of addressing the procedural problems, the Narendra Modi government in 2014 decided to improve “ease of business” conditions for the food processing industry by recasting the entire proprietary food safety regime just the way industry wanted. It brought in separate sets of regulations for proprietary foods, novel products and health supplements. The regulations for proprietary foods, the CAG found, were put in place in January 2016 without consulting scientists of the food safety authority.

The safety of a processed food product depends not only on the safety of its ingredients but also how the ingredients are mixed together – this is known as “combinatorial effect”. As an example, the first story in this series explained, caffeine and ginseng are safe to have separately, but when mixed in an energy drink they make for a dangerous cocktail.

But, the new regulations for ‘proprietary food products’ give the food processing industry the freedom to combine pre-approved ingredients in whichever ratio they wish, attest to the safety of these products and sell them.

Previously (at least on paper), scientific panels established by the food safety authority were required to examine whether such combination of different ingredients in new products were safe for humans before they were allowed into the market.

That is not all. A manufacturer now also gets to choose the category of standardised food it wants to label its product under. For each category of standardised food, such as dairy products, the food safety authority prescribes the additives that can be used and in what quantities. Additives are preservatives and other chemicals that go into processed food, in addition to the main ingredients.

Who benefits?

The food processing industry had long been complaining about the old safety regulations, claiming they were arbitrary. It got its wish for new regulations in August 2014. Records maintained by the food processing ministry show the principal secretary to the prime minister conducted a meeting on food safety regulations, which concluded: “Prior product approval shall not be necessary for proprietary products which use ingredients allowed in any standardized food or category. Similarly, no prior approval shall be required for food products using additives already permitted by FSSAI.”

Following directions from the Prime Minister’s Office, the food processing ministry prepared a detailed note on changing the rules in February 2015. It recommended that non-standardised foods that use already approved ingredients and additives should not be scrutinised: manufacturers certifying their safety would be good enough.

The Federation of Indian Chambers of Commerce and Industry chimed in to suggest that easier rules would help “facilitate continuity of Indian food processing business”. The chairperson of the food safety authority, Ashish Bahuguna asked that the industry association’s recommendations be read by all officials and experts formulating the new regulations.

A task force set up by the food safety authority also gave its report which made some recommendations along the lines the Prime Minister’s office had earlier decided.

However, the authority’s chief executive officer at the time opposed easing the rules, the records show. YS Malik opposed the food industry’s demand to ignore the combinatorial effect of the ingredients in proprietary foods even as he promised to regularise and speed up the existing system. “ (Industry’s) argument appears to be based on the premise that the concept of combinatorial effect does not operate qua the use of such ingredients on the end food product,” he said in an open letter to the industry in May 2015. “This is a misnomer. It is not necessary that food ingredients, which are reckoned as safe individually, shall also remain safe when produced in combinations.”

He added: “Most of the FBOs – Food Business Operators – especially the aggrieved ones appear to be swearing by the Hon’ble Prime Minister’s ‘Make in India’ initiative conveniently forgetting that it is also accompanied by the words ‘Zero Defect and Zero Effect’.”

By September 2015, Malik had been transferred out, in what was seen as a reaction to the food safety authority taking strong action over the alleged contamination in Nestle’s Maggi noodles, a proprietary food product.

The new leadership of the food authority aligned its opinion to be in congruence with that of the food processing industry. The new regulations came into operation in January 2016, even before they were formally notified. To do this the government used a clause of the food law that it can only use in a matter of “urgency concerning food safety or public health”, the CAG pointed out. The new regulations were eventually notified in October 2016, with a few minor changes.

'Prior product approval shall not be necessary for proprietary products which use ingredients allowed in any standardized food or category. Similarly, no prior approval shall be required for food products using additives already permitted by FSSAI'. Photo credit: Reuters

Food authority’s defence

Responding to detailed questions from, the food authority said, “Proprietary foods are made from standardised ingredients or ingredients which are allowed in standardised products. Any product prepared by using such ingredients is expected to be safe unless there is specific scientific evidence to the contrary.”

The authority failed to point out that, unlike proprietary food items, standardised food products are made from mixing known ingredients in ratios that have been approved after scientific assessment.

The food safety authority’s current CEO, Pawan Kumar Agarwal, defended the changes. In a telephonic conversation, he said: “From your questions, it seems they are being dictated to you.”

Informed that’s queries were based on government documents, he questioned the source of the documents. “The person who has given you the documents, he or she has vested interests,” he claimed.

In a written reply to, the food authority separately added, “It is the responsibility of the Food Business Operator to comply with these standards to manufacture safe food. It may be pointed out that similar responsibility is also assigned to Food Business Operators who manufacture standardised products for which no separate product approval is required.”

It also claimed “the regulation relating to proprietary food was notified after intensive deliberations and it covers all applicable provisions as stipulated in the [Food Safety and Standards Act] and the Regulations, hence the safety of the food is not compromised.”

The Prime Minister’s Office did not respond to written questions. The food authority claimed it had done away with the old rules not on orders from the Prime Minister Office’s but because they had been rejected by the courts. It failed to mention that the Bombay High Court had rejected the previous rules merely for procedural reasons and it had not prescribed what the new regulations should be.

Justifying the relaxation of safety norms for proprietary foods, Agarwal offered the example of the traditional sweet dish, kheer. “Earlier we were into recipes,” he said. “Now we don’t want to get into recipes. Take, for example, kheer. Your milk is safe and your sugar is safe. What would be the quantity in which you mix them together, we do not want to get into.”

However, home-made kheer is a traditional recipe that the food law does not cover. The law covers processed and packaged food that companies produce by mixing chemicals and ingredients in new ways and ratios.

Standards elsewhere

India is not the only country that has to deal with new processed foods for which standards do not exist. The European Union has some of the strictest regulations governing such foods. Any food or food ingredient that has not been consumed within the European Union member countries before 1997, when the first novel food regulations were implemented, is not permitted to be sold without scrutiny of all scientific information pertaining to its safety.

In the United States, scrutiny of the product itself is not required but each ingredient and additive is scientifically assessed for use in a specific food product or class of food products. Food companies are required to either provide strong evidence that the ingredient has been traditionally and widely consumed in the US and widely considered safe by food safety experts. If not, it has to the prove that the ingredient is new and the company has conducted enough scientific research to establish its safety. Even after the product is approved, citizens can ask for greater scrutiny of the ingredients. Additionally, the US Food and Drug Administration has a well-established programme to continually monitor the sale and health effects of new ingredients. Even then, the US system is considered relatively weak because at times it allows dangerous ingredients to be sold without deeper scrutiny.

India’s new regulations, which are even easier on the industry than those in the US, were drafted with inputs from the US-India Business Council.

Read the first part of this series here.