Short title and commencement: –

1.1 These Regulations may be called the “Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2016”

1.2 They shall come into force with effect from the date of their final publication in official gazette.

2. Definitions: – Unless the context otherwise requires, —

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

2.2 “Approval” in the context of these regulations means permission to manufacture, distribute, sell or import any article of food and food ingredients, intended directly or indirectly for human consumption, that has not been permitted under any other regulation made under the FSS Act, 2006.

2.3 All other words and expressions used herein and not defined, but defined in the Act or rules and regulation made thereunder, shall have the meaning as assigned to the same in the Act, Rules or Regulations

3. Scope: –

3.1 Only such article of food or food ingredients which have not been permitted to be manufactured, stored, sold, distributed or imported under any other Regulation under the Act shall require prior approval for being manufactured, stored, sold, distributed or imported under the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2016. Such articles of foods and food ingredients shall include:

 Novel foods or foods containing novel ingredients not having a history of human consumption in the country

 Food ingredients with a history of human consumption in the country but not specified in any other Regulation under the Act

 New additives and processing aids

 Foods manufactured or processed with the use of novel technology.

3.2 The provisions in these Regulations shall be read in conjunction with provisions of other Rules and Regulations made under the Act

4. Procedure for grant of approval: –

4.1 The manufacturer or importer shall submit an application as per Annexure I & II along with requisite documents and fee to the Food Safety and Standards Authority of India (FSSAI).

4.2 FSSAI shall scrutinize the application along with the supporting documents and other information enclosed as per annexure I & II. The applicant may be asked to provide additional supporting documents, data or clarifications, if required.

4.3 Based on the safety assessment of the food product, the Chief Executive Officer of the FSSAI, or an Officer authorized by him, may either grant approval or reject the application.

4.4 Where approval is granted, the FBO shall submit certificate of analysis of the product on parameters relating to chemical, nutritional, microbiological, heavy metals, pesticide residues and naturally occurring toxicants to FSSAI.

4.5 The FBO may file an appeal before the Chairperson, FSSAI against any decision of rejection of his application.

4.6 The FBO may file review petition before the Central Government against the decision of the Chairperson, FSSAI and the decision thereon of the Government shall be final.

4.7 FSSAI may, for reasons to be recorded in writing revoke or suspend any approval granted to any FBO which shall be a binding on the FBO.

4.8 FSSAI may specify the amount of application fee and review this amount from time to time.

4.9 In the event of any health risk coming to the knowledge of the FBO in respect of the food for which approval has been given under this regulation, the FBO shall immediately suspend the import, manufacture, sale, or distribution of the said article of food and take steps to recall the same under intimation to FSSAI as per the procedure laid down in the Food Safety and Standards (Food Recall) Regulation, 2016. 3

4.10 All the Food Safety Officers or Designated Officers shall immediately inform the Food Safety and Standards Authority of any complaint received regarding safety of food approved by the FSSAI under these Regulations.

For More detail visit:  http://www.fssai.gov.in/Portals/0/Pdf/Draft_Notice_Comments_Food_Approval_04_10_2016.pdf