(1)      “Act” means the Food Safety and Standards Act, 2006 (34 of 2006);

(2)      “Food Authority” means the Food Safety and Standards Authority of India (FSSAI) established under section 4 of the Act;

(3)   Ayurveda Aahar means a food prepared in accordance with the recipes or ingredients and/or processes as per methods described in the authoritative books of Ayurveda listed under ‘Schedule A’ of these regulations. It also includes products which have other botanical ingredients in accordance with the concept of Ayurvedic Aahar but does not include Ayurvedic drugs or proprietary Ayurvedic medicines and medicinal products, cosmetics, narcotic or psychotropic substances, herbs listed under Schedule E of Drug and Cosmetic  Act, 1940 and Rules 1945 thereunder, metals based Ayurvedic drugs or medicines, bhasma or pishti and any other ingredients notified by the Authority from time to time.

    Explanatory note 1: Food is defined under Food Safety and Standards Act, 2006 and regulations made thereunder. Recipes and ingredients specified in the Schedule A authoritative books for promoting health and including those foods specified for consumption during or post specified diseases, disorders referred as pathya in Ayurveda.

    Explanatory note 2: Adoption of processes for cooking or preparation of Ayurveda Aahar specified or described in the Schedule A authoritative books for industrial scale manufacture and packing are permitted. Such adoptions shall be aimed to produce Ayurveda Aahar with quality and characteristics closely similar as specified in the books mentioned under Schedule A of these regulations.

Explanatory note 3: Any packed food item used in day to day life for dietary purpose such as pulses, rice, flour, vegetable without addition of Ayurveda Aahar ingredient(s) shall  not be covered under these regulations. Minimally processed food items involving cleaning, dedusting, polishing, dehusking, grading shall not fall under these regulations.

(4)   “Schedules” mean the schedules to these regulations.

(1)      No person shall manufacture or sale Ayurveda Aahar  intended for administration to infants up to the age of 24 months.

(2)   The manufacture of Ayurveda Aahar shall be established by Food Business Operators in accordance with the Schedule 4 of Food Safety and Standards (Licensing and Registration of Food Businesses) Regulation, 2011

(3)     FBOs may add or alter the recipes of Ayurveda Aahar by addition of one or more botanicals listed in ‘schedule IV’ of Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 subject to the following:

(i)  Such addition shall be based on adequate scientific rationale and as per Ayurvedic principles including for their levels of usage.

(ii)  Such addition shall be demonstrable for its presence in the final formulation by suitable analytical techniques

(4) Addition of vitamins, minerals and amino acids to Ayurveda Aahar shall not be permitted. However, natural vitamins and minerals if present in the Ayurveda Aahar may be declared on the label.

(5) Food Business Operators shall formulate Ayurveda Aahar in accordance with the categories and requirements specified in Schedule B of these regulations.

4. Additives: The products covered under these regulations shall contain only natural food additives as specified under schedule C of these regulations.

5. Contaminants: The products covered under these regulations shall conform to the safety requirements specified in Schedule D of these regulations. The raw materials used for manufacture of Ayurveda Aahar shall also meet the requirements specified in Schedule D of these regulations. 

6. Packaging: Ayurveda Aahar shall conform to the Food Safety and Standards (Packaging) Regulation, 2018.

7.  No person shall manufacture, pack, sell, offer for sale, market or otherwise distribute or import Ayurveda Aahar unless the product comply with the requirements laid down in these regulations.

8. The labelling, presentation and advertisement shall not claim that the Ayurveda Aahar has the property of preventing, treating or curing a human disease or refer to such properties.

9. Food Business Operator shall make claims in accordance with the Food Safety and Standards (Advertising and Claims) Regulation, 2018. Food Business Operators shall make claims as per description or indications specified for the recipe or ingredient in the authoritative books listed in Schedule A. Such claim statements should be factual, not misleading or exaggerated and be of a documented history of usage. Disease risk reduction and/or health benefits claims shall be pre-approved by the Food Authority.

10. Ayurveda Aahar whose standards are not specified under these regulations shall be manufactured for sale, exhibited for sale or stored for sale only after obtaining approval of such article of food from the Food Authority in accordance with the Food Safety and Standards (Approval for Non-Specific Food and Food Ingredients) Regulation, 2017.  

11.       Ministry of AYUSH shall establish a Expert Committee for providing recommendation to Food Authority on approval of claims and products as specified in sub-regulation 09 and 10 above.  Such Committee shall also empower to address concerns regarding registration/licensing/certification/laboratory accreditation/testing/quality issues related to Ayurveda aahar.

12. The labelling of Ayurveda Aahar shall be in accordance with the Food Safety and Standards (Labelling and Display) Regulations, 2020, and the specific labelling requirements provided in these regulations.

13. Every label of Ayurveda Aahar shall clearly specify the intended purpose, the target consumer group, recommended duration of use and other specific labelling requirements, namely:

a.       The words “AYURVEDA AAHAR” printed in the immediate proximity of the name or brand name of the product; and the logo as specified below in the front of the pack of the label:

b.      An advisory warning ‘ONLY  FOR DIETARY USE’ prominently written;

c.       A statement that the Ayurveda Aahar is not to be used as a substitute for a varied diet;

d.      A warning or any other precautions to be taken while consuming, known side effects, if any, contraindications, and published product or drug interactions, as applicable; and

e.       A statement that the product is required to be stored out of reach of children.

f.       A warning that the product is for oral consumption only and not for parenteral use

14. FBOs shall inform the licensing authorities in writing, if any of their existing food products duly licensed to be assigned as an Ayurveda Aahar and the licensing authority shall permit the same with applicable modifications including labelling as specified in these regulations. The Food Authority may specify  the validity period of such applications.

*Explanatory Note: Ingredients and recipes listed in the above original editions of authoritative books and those authoritative texts written and published before 1940 shall be considered for approval as Ayurveda aahar. Ingredients and recipes listed in appendix or annexure to the above authoritative texts in schedule A shall not be considered for approval as Ayurveda aahar.

Explanatory note 1: Mere adoption of the Ayurveda aahar format for suitability to offer it in pre-packaged condition including format conversion for reconstitution prior to use does not constitute change in format.

*Level basis scientific rationale

Table 1A. Process Hygiene Criteria