NEW DELHI: Nutraceuticals and health and dietary supplements such as fortified foods and energy drinks will no longer be considered proprietary food by India's regulator, according to revised rules, and they will likely have to be approved as a separate category.
The Food Safety and Standards Authority of India (FSSAI) has amended regulations to fix loopholes in the definition of proprietary food, under which approval had been sought for several nutraceutical and
health supplements as proprietary foods.
According to the FSSAI's new regulations uploaded on its website on January 25, proprietary food is now defined as "...an article of food that has not been standardised under these (Food Safety and Standards) regulations, but does not include any novel food, food for special dietary use, functional food, nutraceutical, health supplement and such other articles of food which the Central Government may notify in this behalf."
The regulations specify that "the Food Business Operator shall be fully responsible for the safety of the proprietary food."
The Food Safety and Standards Authority of India (FSSAI) has amended regulations to fix loopholes in the definition of proprietary food, under which approval had been sought for several nutraceutical and
health supplements as proprietary foods.
According to the FSSAI's new regulations uploaded on its website on January 25, proprietary food is now defined as "...an article of food that has not been standardised under these (Food Safety and Standards) regulations, but does not include any novel food, food for special dietary use, functional food, nutraceutical, health supplement and such other articles of food which the Central Government may notify in this behalf."
The regulations specify that "the Food Business Operator shall be fully responsible for the safety of the proprietary food."
"Proprietary food shall use only such additives as specified for the category to which the food belongs and such category shall be clearly mentioned on the label along with its name, nature and composition," according to the regulations known as the Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2016.
"Nutraceuticals and food supplements will now have to be approved under the regulations for nutraceuticals," an FSSAI official said.
India's nutraceuticals market is estimated to cross $6.1 billion by 2020 from $2.8 billion, according to a study by the Associated Chambers of Commerce & Industry of India and market research firm RNCOS in August. Nutraceuticals can be classified as dietary supplements, including vitamins and minerals, and functional food and beverages such as those fortified with omega fatty acids and probiotics and energy and sports drinks.
Following the controversy over the regulator's ban of Nestle's Maggi instant noodles, which the Bombay High Court lifted in August, and the product approval process, which was quashed by the Supreme Court in the same month, the Ministry of Health and Family Welfare had said that the government plans to review and amend the Food Safety and Standards Rules, 2011.
The food regulator recently uploaded a list of 8,000 approved additives after setting new standards for them, the food categories in which they can be used and their permissible limits. It is also preparing new standards for product approval.
"Nutraceuticals and food supplements will now have to be approved under the regulations for nutraceuticals," an FSSAI official said.
India's nutraceuticals market is estimated to cross $6.1 billion by 2020 from $2.8 billion, according to a study by the Associated Chambers of Commerce & Industry of India and market research firm RNCOS in August. Nutraceuticals can be classified as dietary supplements, including vitamins and minerals, and functional food and beverages such as those fortified with omega fatty acids and probiotics and energy and sports drinks.
Following the controversy over the regulator's ban of Nestle's Maggi instant noodles, which the Bombay High Court lifted in August, and the product approval process, which was quashed by the Supreme Court in the same month, the Ministry of Health and Family Welfare had said that the government plans to review and amend the Food Safety and Standards Rules, 2011.
The food regulator recently uploaded a list of 8,000 approved additives after setting new standards for them, the food categories in which they can be used and their permissible limits. It is also preparing new standards for product approval.
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