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The Food Safety and Standards Authority of India (FSSAI) on October 04, 2016 published 2 draft regulations related to “fortification of food” and “approval of non-specified food and food ingredients”.

Fortification of food

This draft regulation has been provisionally titled “Food Safety and Standards (Fortification of Foods) Regulations, 2016”.

The main highlights of the legislation are as follows:

- The manufacturer of food fortified with micronutrients shall not add them below levels as specified by this legislation.
- The manufacturer is also obligated towards quality assurance and should be able to provide evidence of compliance by getting the product tested in a FSSAI recognized lab in addition to updated record keeping.
- Specific packaging and labeling requirements apply to these foods in addition to compliance with  provisions of Food Safety and Standards (Packaging and Labeling) Regulations, 2011:

Every package of fortified food shall carry the words “fortified with ………… (name of the fortificant)” on the label. Every package of food, fortified with Iron shall carry a statement “Not recommended for people with Thalassemia and people on low iron diet”.

The legislation also specifies the standards for fortification of: salt, vegetable oil, milk, vanaspati, atta, maida and rice

Approval of Non-specified food and food ingredients

This draft regulation has been provisionally titled “Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2016”.

Those articles of food or food ingredients which have not been permitted to be manufactured, sold, stored, distributed or imported under any other regulation shall require pre-approval from the authorities. Types of such articles of food include:

- Novel foods or foods containing novel ingredients not having a history of human consumption in the country.
- Food ingredients with a history of human consumption in the country but not specified in any other Regulation under the Act.
- New additives and processing aids.
- Foods manufactured or processed with the use of novel technology.

The approval shall be granted by FSSAI when the manufacturer or importer submits an application to FSSAI with the supporting documents as specified as per the regulation.

At the outset, the supporting documents shall include extensive evidence on: Composition and Source of the ingredient,  Documentary evidence for the regulatory status of the ingredient, Functional and intended use of the product/ ingredient Certificate of analysis from a 3rd party NABL or FSSAI recognized laboratory , Proposed label for the product, Method for manufacture, Specific conditions of storage, History of product consumption, Safety studies, Regulatory status of the product in other countries with level of consumption permitted.

Posted by Selerant RSA on Oct 14, 2016

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