The FSSAI has issued a notification dated 30 June 2021 regarding the draft Food Safety and Standards (Ayurveda Aahar) Regulations 2021. FSSAI has also invited objections and suggestions, which must be sent according to the format available on the following webpage www.fssai.gov.in and may be addressed to Chief Executive Officer, Food Safety and Standards Authority of India, Food and Drug Administration Bhawan, Kotla Road, New Delhi – 110002. The objections and comments may also be submitted online or emailed to regulation@]fssai.]gov.in within 60 days from 5 July 2021 (date of uploading).
These regulations may be called as the Food Safety and Standards (Ayurveda Aahar) Regulations, 2021.
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.
- General requirements
(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.
- Additives: The products covered under these regulations shall contain only natural food additives as specified under schedule C of these regulations.
- 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.
- Packaging: Ayurveda Aahar shall conform to the Food Safety and Standards (Packaging) Regulation, 2018.
- No person shall manufacture, pack, sell, offer for sale, market or otherwise distribute or import Ayurveda Aahar unless the product complies 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.
- 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.
- 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.
- Ministry of AYUSH shall establish an 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.
- 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.
- 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
- 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.
List of authoritative books for Ayurveda Aahar
*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.
Definition related to Ayurveda Aahar is as provided in Food Safety and Standards (Ayurveda Aahar) Regulations, 2020.
Stage where the Microbiological Standards shall apply:
The microbiological standards with respect to the products categories specified as Process Hygiene Criteria indicate the acceptable functioning of the production process. These are not to be used as requirements for releasing the products in the market. These are indicative values above which corrective actions are required in order to maintain the hygiene of the process in compliance with food law. These shall be applicable at the end of the manufacturing process. The Microbiological Standards as Food Safety Criteria define the acceptability of a batch/lot and shall be met in respect of the products at the end of the manufacturing process and the products in the market during their shelf- life.
Action in case of unsatisfactory result:
In case of non-compliance in respect of process hygiene criteria, the FBO shall:
- check and improve process hygiene by implementation of guidelines in Schedule 4 of FSS (Licensing and Registration of Food Businesses) Regulations; and,
- ensure that all food safety criteria are complied with.
Sampling Plan and Guidelines
For Regulator: The sampling for different microbiological standards specified above shall be ensured aseptically at manufacturing units and/or at retail points, as applicable, by a trained person with specialized knowledge in the field of microbiology following guidelines in the Food Safety and Standards (Food Products and Food Additives) Regulations, 2011 and ISO: 707 (Latest version). The samples shall be stored and transported in frozen condition at -18°C(±2°C) or under refrigerated conditions at 2-5°C as applicable except for the products that are recommended to be stored at room temperature by the manufacturer to enable initiation of analysis within 24 hours of sampling.
Preservatives shall not be added to sample units intended for microbiological examination. The desired number of sample units as per sampling plan given in Tables above shall be taken from same batch/lot and shall be submitted to the notified laboratories. Three sets, each containing ‘n’ number of samples (n as defined in the sampling plan egg if n=5, then total no. of samples to be drawn is 15) shall be drawn. Each of these three sets shall be tested in three different accredited laboratories. The final decision shall be based on the results of three accredited laboratories. In the case of Food Safety Criteria, the results from all the three laboratories should indicate compliance with the specified criteria. There will be no provision for retesting or resampling for microbiological testing. The testing in laboratory shall be ensured as per the methods given in the table “reference test methods”
For FBO: Food Business Operator (FBO) shall perform testing as appropriate as per the microbiological standards specified in the tables above to ensure verification of compliance with the microbiological requirements. FBO shall decide themselves subject to minimum prescribed under FSSR (Licensing and Registration of Food Businesses), the necessary sampling and testing frequencies to ensure compliance with the specified microbiological requirements. FBO may use analytical methods other than those described in “reference test methods” given below for in-house testing only. However, these methods shall not be applicable for regulatory compliance purpose.
The terms n, c, m and M used in this standard have the following meaning:
n = Number of units comprising a sample.
c = Maximum allowable number of units having microbiological counts above m for 2- class sampling plan and between m and M for 3- class sampling plan.
m = Microbiological limit that separates unsatisfactory from satisfactory in a 2- class sampling plan or acceptable from satisfactory in a 3-class sampling plan.
M = Microbiological limit that separates unsatisfactory from satisfactory in a 3-class sampling plan.
Source : FSSAI