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On October 11, 2022, the Food Safety and Standards Authority of India (FSSAI) published the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) First Amendment Regulations, 2022 (hereinafter the new Regulations) to replace the 2017 version. The new Regulations comes into force on the promulgation date.
Major Changes
The procedure for the grant of prior approval is detailed.
In India, no person shall manufacture or import any non-specified food or food ingredient, except with the prior approval of FSSAI. Non-specified food or food ingredient refers to food or food ingredient (including additive, processing aid, and enzyme) that have not been specified under the Food Safety and Standard Act, 2006.
The whole procedure specified in the new Regulations is summarized below. The amendment mainly adds some new requirements (remarked in red), including the detailing of timelines and the request of post-market surveillance data. In addition, the procedure for food business operators to file appeal or review petition is complemented with details.
Procedures for Granting Prior Approval of FSSAI
The application form is perfected.
FORM 1, the application form given in the Regulations, is revised as well. Amendments include:
a more systematical classification of non-specified food and food ingredient;
detailed requirements for products claiming health benefits;
the request for some extra information, such as a copy of the proposed product prototype label as well as the name, address, and contact details of the manufacturer or processing premise, etc.
Moreover, the new Regulations offers two formats for applicants to provide the summary of data for safety and for health benefit claims, respectively.
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