FSSAI issued the First Amendment to the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations 2017.

FSSAI, vide notification dated 11 October 2022, amended the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017. These regulations are now called the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) First Amendment Regulations, 2022, which will be effective from the date of their publication in the Official Gazette. The following amendments are added to the said regulations.

1. Regulation 4 is related to the "Procedure for grant of prior approval". The manufacturer/importer must apply for a grant in Form-I, along with documents and fees. After the Food Authority scrutinises the application, they may appoint an expert committee to examine the application. The Authority may either approve or reject the application, as per FORM-II. The FBO must conduct and produce the post-market surveillance data to the Authority. If the application gets rejected, the FBO can appeal to the CEO and Chairperson.
2. Form-I is the application form for approval of non-specified food and food ingredient.
3. General Information should contain the applicant's name, contact number, email, organisation name, address, license number, nature of business, justification of the name, product category, source of food ingredients (genus and species of animal, botanical or micro-biological source) and functional benefits.
4. The manufacturer must have a Certificate of Analysis from the NABL /ILAC. In addition, other documents like manufacturing flow sheets, regulatory status, agreement copy, risk assessment/ safety information, claim support documents, copy of proposed prototype, and post-marketing surveillance data are needed.
5. Additional information related to Novel food/ingredients, New additives, New processing aids, including enzymes and the Nature of microbe Bacterium/Yeast/Fungi/Algae.
6. Annexure A states the Format for providing a summary of safety (pre-clinical toxicology) investigations.
7. Annexure-I contains details to be provided in a summary of in-vitro data.
8. Annexure B displays the Format for providing a summary of data for health benefit claims related to in-vitro, in-vivo data, meta-analyses and human study data.
9. Form II is the approval/rejection form issued by Food Authority to indicate the application status.