FOOD SAFETY AND STANDARDS (APPROVAL FOR NON-SPECIFIED FOOD AND FOOD INGREDIENTS) REGULATIONS, 2017

PREAMBLE

Whereas the draft of the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017 were published as required under section 92 of the Food Safety and Standards Act, 2006 (34 of 2006), vide notification of the Food Safety and Standards Authority of India number F.No. 12/PA Regulation/Dir (PA)/FSSAI-2016, dated the 31st January, 2017, in the Gazette of India, Extraordinary, Part III, Section 4, inviting objections and suggestions from the persons likely to be affected thereby, before the expiry of the period of thirty days from the date on which the copies of the Gazette containing the said notification were made available to the public;

And whereas copies of the said Gazette were made available to the public on 9th February, 2017;

And whereas objections and suggestions received from the public in respect of the said draft regulations have been considered by the Food Safety and Standards Authority of India;

Now, therefore, in exercise of the powers conferred by clause (v) of sub- section (2) of section 92 of the said Act, the Food Safety and Standards Authority of India hereby makes the following regulations, namely:-

Regulation - 1Short title and commencement.--

(1)     These regulations may be called the 'Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017.'

(2)     They shall come into force on the date of their publication in the Official Gazette.

Regulation - 2. Definitions.--

(1)     In these regulations, unless the context otherwise requires: -

(a)      "Act" means the Food Safety and Standards Act, 2006 (34 of 2006);

(b)      "Approval" means a permission to manufacture or import any article of food or food ingredients, intended directly or indirectly for human consumption, that has not been specified under any other regulations made under the Act;

(c)      "Food Authority" means the Food Safety and Standards Authority of India established under section 4 of the Act;

(d)      "Non-specified food" means any food other than proprietary food or food ingredients, including additives, processing aids and enzymes for which standards have not been specified in any regulation made under the Act.

(2)     The words and expressions used herein and not defined, but defined in the Act or rules or regulations made thereunder, shall have the meaning as assigned to them in the Act, rules or regulations.

Regulation - 3. Prior approval for manufacture, storage, sale, distribution, import, etc.--

(1)     No person shall manufacture or import any non-specified food or food ingredient, as the case may be, except with the prior approval of the Food Authority.

(2)     The provisions of these regulations are in addition to, and not in derogation of, any other rules or regulations made under the Act.

Regulation - 4. Procedure for grant of prior approval.--

(1)     The manufacturer or importer of non-specified food shall submit an application in FORM - I of these regulations along with necessary documents and fee to the Food Authority.

(2)     The Food Authority shall scrutinize the application and information provided by the applicant.

(3)     The Food Authority may direct the applicant to submit additional supporting documents, data or clarifications, if required.

(4)     The Food Authority may either grant approval or reject the application, as per FORM-II, on the basis of the safety assessment of the article of food.

(5)     Where approval is granted, the food business operator shall submit to the Food Authority, a certificate of analysis in respect of the chemical, physical, microbiological and nutritional parameters of the food manufactured or imported.

(6)     The food business operator may file an appeal before the Chairperson, Food Authority against any decision of rejection of his application.

(7)     A food business operator, who is aggrieved by the decision of the Chairperson, Food Authority may file review petition to be placed for consideration in the meeting of the Food Authority.

(8)     The Food Authority may, for reasons to be recorded in writing, suspend or revoke any approval granted to any food business operator.

(9)     The Food Authority may review from time to time, the amount of fee for filing an application.

(10)   If a food business operator has reason to believe that the food for which the approval has been granted poses any risk to health, he shall immediately suspend the manufacture, import, sale, or distribution of such article of food and take steps to recall the same under intimation to Food Authority in accordance with the provisions of the Food Safety and Standards (Food Recall) Regulations, 2017.

(11)   Food Safety Officers and Designated Officers shall immediately inform the Food Authority of any complaint received regarding safety of any product approved by the Food Authority under these regulations.

(12)   The food business operator shall, after grant of approval apply for license as per the procedure specified in the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011.