In India the Food Safety and Standards Authority of India (FSSAI) is the apex food regulator. It is empowered by and functions under the Ministry of Health and Family Welfare, Government of India. The FSSAI implements and enforces food regulations as prescribed in the Food Safety and Standards Act, 2006 (FSS Act). The FSS Act is an Act of Parliament, popularly known as the Food Act. Previous to the FSS Act there were a number of food legislations. All these have been consolidated into a homogenous whole in the FSS Act. The regulations of the FSS Act became effective in 2011 with FSSAI as its regulatory body. Though the Act continues to evolve it needs to be further harmonized with standards of international agencies for global parity.
Categorized as Standardized or Non-Standardized
In the FSSAI regulations, food products fall into two categories—standardized and non-standardized. The standardized food products are those for which standards are prescribed and do not require product approval prior to manufacture, sale, distribution, or import. The first time manufacturer or importer of standardized foods only requires an FSSAI license to begin a food business.
Non-standardized food products do not have standards as their safety parameters are either not known or not yet ascertained. Presently FSSAI has standardized only 380 articles of food in 16 categories so all other foods require product approval if they are not listed among these 380 food items. FSSAI is working to standardize another 12,000 more foods for which the process is nearing finalization in harmonization with Codex Alimentarius.
Traditional foods also do not require product approval as they are being consumed for centuries in India. The ingredients and preparation methods are well known and this guarantees their safety. If, however, traditional foods use any new ingredients or food additive or new technologies in preparation, they need product approval.
Foods Imported into India have to follow the FSS Act, Rules & Regulations If the food articles are standardized, the importer only needs a FSSAI license to import them. The importer also needs to comply with FSSAI regulations for sale and distribution of the food products.
If a new or unknown food article is introduced for import, it is considered non-standardized and requires product approval under the Section 22 of the FSS Act, 2006. The FSS Act, 2006 does not apply to foods being exported out of India. Exporters do not require FSSAI product approval as these food products are not sold to Indian consumers.
Non-standardized food products, awaiting product approval, are assessed for safety in four categories. To expedite product approval, a 90-day outer limit is now in place for completion of the application review process. However, if the product is referred to the Scientific Panel for further scrutiny, the time limit could be extended. The 90-day time limit has three, 30-day cycles that constitute the various application review stages. This facilitates applicants in tracking the application status at various stages of the approval process and on approval they can immediately apply for license.
What are the New Draft Regulations?
New Draft Regulations have been formulated by FSSAI. Of special interest is Section 22 of the FSS Act, which deals with “Nutraceuticals, Functional Foods, Novel Foods and Health Supplements.” For the first time regulations have been proposed for this category of foods. If these products propound nutritional or medicinal benefits they need to have sound scientific evidence. The products must not contain either steroids or psychotropic drugs. Ingredients like vitamins and minerals must conform to the recommended dietary allowances for Indians, as proposed by the Indian Council of Medical Research.
The existing process of product approval for the food articles governed under Section 22 of the FSS Act has been discontinued as updated on August 26, 2015 by FSSAI in response to the ruling by Honorable Supreme Court of India. The regulations on such food products are expected soon and the product approval may be reintroduced through a regulation.
Baskaran says
Gives complete insight on FSSAI rules & regulations
Dr. Saurabh Arora says
Thank you Baskaran, please feel free to ask any questions you have I will be happy to answer them here.
Deepika says
How do retailers control damages pertaining to poor delivery performance by vendors?
Kunal Tyagi says
What is the current process now to Import Health Supplements or to get product approval for existing product in market. Is FSSAI giving provisional NOC or it is not at all allowing any product approval for Imports or it is free flow to Import the health supplements into India.
Dr. Saurabh Arora says
Hi Kunal, There is a draft regulation on nutracuticals which should get formalized soon then it will be clear how to go about importing nutraceuticals.
Parul says
please confirm which nutraceutical products requires product approval or which requires only central license.
Murthhy says
Is there any process or regulation to sell homemade foods? Any licenses required for selling homemade food online?
Dr. Saurabh Arora says
Dear Murthhy, if your annual sale will be less than 12 lakhs you have to register and if it is ore than 12 you have to take a lic.
kumar says
i just need to supply manufactured local traditional foods from one state to other states through online process.do i need to register for that or have to opt for license. does i need to register a company . kindly help me.
thanks
Dr. Saurabh Arora says
Hi Kumar you will need a license/registration for doing this.
Namrata Singh says
Please share the current problems related with food safety in India and its implementation, prevalent even after the enactment of the new FSS Act. And what suggestions and recommendations would you give to solve them?
Dr. Saurabh Arora says
Hi, namrata there are a million answers to your question but the most important is that there is a need to increase the level of awareness with both food businesses and consumers about food safety and its importance.
Tamanna says
As Namrata asked, could you please tell us the current problems withe Food Safety and Standards in India and how it would be best to solve them?
Minal says
Are there any guidelines on how much flavour (nature identical and or artifical) can be used per 500gms of product?
Diwakar says
Dear Dr Saurabh,
We looking for any food safety norm required food pet food manufacturing. Which agency looks after manufacturing/packing/processing of pet food for dog, cat etc.
Waiting for reply
Remsy THARAKAN says
No agency in India is currently looking on Petfood Manufacture/packaging etc. Please correct me if there is any recent regulation from FSSAI?
Dr. Pradeep Visen says
Hello Dr. Saurabh,
Going back to Mr. Kunal Tyagi’s question, it means, at present, we can import finished nutraceuticals, without prior product approval, for marketing, following guidelines of labels, claims etc. Is it applicable?
Thanks & regards
Dr. Pradeep Visen
Former scientist, CDRI, Lucknow
Director, Nutra-V Natural Care Pvt. Ltd., Lucknow
Saeed says
Dear Sir, Please advice. Which one is the current FSSAI India “Food Additives (Preservatives, Colors) & Standards” standard already in force. Will you please provide link.
Pravesh Chaubey says
Dear Saeed,
FSSAI released new notification and amend the existing standards for additives with following standards.
http://www.fssai.gov.in/Portals/0/pdf/Gazette_Notification_Additive_Harmonization_16_09_2016.pdf
Thanks
Pravesh
Radha says
Dear Sir,
I make masala products and sell to friends and relatives. Planning to introduce the products online and to nearby stores…pls guide me if I need to apply for food safety license and criteria to obtain it.
Pream Madarasinghe says
Dear Sir, Please advice.
Following enzymes were mentioned with GM resources, under the FSSAI Regulations
1100(iv) alpha-Amylase from Bacillus megaterium expressed in Bacillus subtilis
1100(v) alpha-Amylase from Bacillus stearothermophilus expressed in Bacillus subtilis
For the above GM enzymes, would they be considered as Standardized Food Additive – no need to register?”
Please advice.
Thank you.
Pream Madarasinghe-Sri Lanka
Ananthanarayanan Padmanabhan says
We manufacture Ricinolic acid (RA) from castor oil ( after a hydrolysis process).t.
RA is listed as a fatty acid – INS No. 570.
Since castor oil is vegetable oil, am I right in saying that castor oil does not require product approval, as it is not listed as a commodity in fssai ac
Vinay Poojari says
Your comment is awaiting moderation.
Hi, I wanted to know if I own a Hotel which includes lodging and ancillary services & wherein I have outsourced the entire F & B function to a 3rd Party Vendor who has registered for FSSAI License for all products provided by him for the aforementioned hotel including packaged drinking water and other products which are provided to Customers as per package plan for the Room + Food.
Would I require to register or even apply for an FSSAI license being the Hotel Owner?
varsha Singh says
Is there any regulatory body in India that deals with nutritive value/ production/ marketing of pet food ?