Aug 21, 2015

How legitimate is FSSAI’s product approval mechanism?

Companies have expressed unhappiness with FSSAI’s product approval procedures in the past
SC questioned the product approval process followed by the FSSAI.
New Delhi: The Supreme Court on Wednesday questioned the product approval process followed by the Food Safety and Standards Authority of India (FSSAI), delivering the second judicial rebuke to the food safety regulator within a week.
Sure, companies have expressed unhappiness with FSSAI’s product approval procedures in the past. But this was probably the first time the apex court has questioned the authority, which suffered a setback on 13 August when the Bombay high court set aside the regulator’s ban on the sale of Nestle India Ltd’s Maggi noodles.
Here’s how the country’s food regulator goes about approving food products and declareing them safe for consumption.
The producer or marketer of a product needs to submit an application – electronically or manually – with supporting documents and analysis reports from accredited laboratoties, along with an image of the pack.
FSSAI’s product committee scrutinizes the documents and approves or rejects them or seeks further documentation. The scrutiny process is complicated and entails about a dozen steps, according to the FSSAI’s website.
“A company seeking approval for a particular product or a variant of a product does not require submitting the sample of the product. So, FSSAI does not conduct tests before giving approval to a particular product,” aid an executive at a multinational packaged foods company requesting anonymity.
“The approval comes based on the documents and reports from accredited laboratories that the company submits along with the application,” the same executive said.
FSSAI chief executive officer Y.S. Malik did not respond to emails seeking comment. Malik also did not respond to official requests for a meeting.
According to executives at multi-national food and beverages companies, typically product approval takes about 18 months. The fee for product approval is Rs25,000 for every variant of any product. And, if rejected, a company can reapply for approval any number of times. The company needs to pay an additional Rs25,000 in case the new product approval application requires intervention by FSSAI’s scientific panel.
FSSAI has only set 377 standards for food items. If it wants to change increase the number of notified standards, the regulator would have had to go to Parliament for approval to introduce the new standards, said a lawyer who has recently represented a company in a food safety related case.
According to the lawyer, FSSAI has taken the short-cut called ‘product approval’ route by way of issuing advisories so that it does not require to seek approval from Parliament.
Between January 2010 and May 2013, the regulator issued nine different advisories changing earlier prescribed rules, according to the FSSAI website.
According to the Food Safety and Standards Act, every proprietary product, especially packaged food items – existing or new, ingredients and additives for which FSSAI does not have any notified standards-- need to be approved by FSSAI to ensure food safety.
Even for already approved products, minor compositional changes in ingredients require product approval. Similarly, approved products with changed claims on the label require approval. However, traditional ethnic foods (like chiwda, halwa, jalebi, rasaogolla, idli and dosa batter) are not required to get product approval provided they contain only the permitted quantity of food additives.
According to information available on the FSSAI website, the regulator has evaluated 14,000-15,000 product approval applications since January 2012.
According to a presentation by the FSSAI, the regulator’s job is to ensure safety of more than 2 billion meals per day in the country, bring about 35 million food and beverages outlets under licence and surveillance, enforce the new safety regulations uniformly across the wide spectrum of registered food vendors across the country. Apart from this, FSSAI looks into imported food items, their standards and labeling.
And to perform these tasks, the FSSAI has just about 30 people working at its headquarter in New Delhi.
Besides manpower, there are other issues. FSSAI conducts inspections and surveillances help of the state-level food authorities to ensure food safety. Here, the inspectors pick up random samples, and test those at laboratories which is limited to a network of four referral and about 86 local ones that have the regulator’s approval. It also needs laboratories for testing of imported packaged food and ingredients that FSSAI seizes at ports and airports.
Importers are not happy. “There’s no set standard, and FSSAI seem to be either too lethargic, or horribly short of manpower. It takes months to get clearance for a consignment if it gets stuck at FSSAI door,” said the owner of a Kolkata-based packaged tea company.
The firm was importing jasmine flowers that were to be used in producing jasmine tea packs. “Since it was imported from a different country and not from the usual one, FSSAI seized the consignment of $50,000 for inspection. We followed it up for about eight months (while the flowers would have just a few weeks of shelf life) and then let it go,” said the official.
The experience was more painful for the owner of a Delhi-based cheese company who was importing cheese worth $2.5 lakh last year. “FSSAI simply does not have the capacity to handle these. Surveillance is fine, but they should do it quickly so that the business does not suffer. As the cheese consignment was not kept in a cold store, and FSSAI kept it at the port for months, it was a complete waste. And our business suffered,” said the cheese company owner.
Both the importers said FSSAI do not have the cold store facilities, and most of the consumable products go waste because of the time that FSSAI takes.
FSSAI was set up under the Food Safety and Standard Act, 2006 that was passed by the Government in August 2011. The Act was brought in to create a single independent statutory body for food laws, standards and enforcement (that regulates standards for manufacturing, distribution, sale and import of all kinds of food in India),.
FSSAI asked the government for about Rs5,000 crore to scale up. But in the 12th five year plan (2012-17), the government allocated only Rs2,350 crore to it.

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