Lok Sabha Question No. 357 (UNSTARRED), answered on 2019-11-19
Subject: Application of New FPIs
Ministry: FOOD PROCESSING INDUSTRIES
Asked by: Amol Ramsing Kolhe, Sunil Dattatray Tatkare, Subhash Ramrao Bhamre, Supriya Sadanand Sule, Kuldeep Rai Sharma, A.K.P. Chinraj

## GOVERNMENT OF INDIA MINISTRY OF FOOD PROCESSING INDUSTRIES

## LOK SABHA UNSTARRED QUESTION No. 357

ANSWERED ON 19 TH  NOVEMBER, 2019

## APPLICATION OF NEW FPIs

357. DR. AMOL RAMSING KOLHE: SHRI SUNIL DATTATRAY TATKARE: DR. SUBHASH RAMRAO BHAMRE: SHRIMATI SUPRIYA SULE: SHRI KULDEEP RAI SHARMA: SHRI A.K.P. CHINRAJ:

Will the Minister of FOOD PROCESSING INDUSTRIES be pleased to state:

- (a) the time duration taken to give approval for a new product put up by entrepreneurs in the field of Food Processing Industry;
- (b) the details of number of applications of food processing unit pending with the competent authorities during each of the last three years and the current year;
- (c) whether there is a big problem in getting a new product approved by entrepreneurs in the field of Food Processing Industry, if so, the details thereof and the reasons therefor;
- (d) whether the Government has devised any solution to the problem of delays faced by the entrepreneurs  in  obtaining  product  approval  from  the  authorities  concerned,  if  so,  the details thereof and if not, the corrective steps taken in this direction; and
- (e) the other steps taken by the Government to expedite the clearance of approvals?

## ANSWER

## THE MINISTER OF STATE FOR FOOD PROCESSING INDUSTRIES (SHRI RAMESWAR TELI)

- (a): Food Safety and Standards Authority of India (FSSAI) under Ministry  of Health and Family  Welfare,  has  the  mandate  for  dealing  with  the  matters  relating  to  Food  Safety  and Standards.

As per information provided by FSSAI, the Food Safety and Standards

(Approval of non-specified food and food ingredients) Regulations, 2017 were notified in  the Gazette  of  India  on  11th  September,  2017  for  the  approval  of  non-specified  food/  food ingredients  including  novel  food  /food  ingredients.  The  time  duration  taken  to  grant  a  new product approval under the said Regulations is  approximately 4 to 6 months from the date of submission of the application depending on the completeness of the information submitted by the applicant. However, it may take a longer time, if sufficient information on safety and efficacy of the product is not available.

- (b): The details of the applications received under the said regulations, as   per information shared by FSSAI, are as follows:

| (i)   | Total Number of applications received till date:   |   290 |
|-------|----------------------------------------------------|-------|
| (ii)  | Number of applications processed and disposed of:  |   174 |
| (iii) | Number of applications that is under process:      |   116 |

The year-wise break up of pending 116 applications under process is as below:

I. 2017: 03

II.2018: 40

III.2019:

73

(c): FSSAI  has  informed  that  as  per  requirements  of  the  Food  Safety  and  Standards (Approval  of  non-specified  food  and  food  ingredients)  Regulations,  2017,  any  new  product approval application needs to provide complete information regarding its safety and efficacy. These new products need to undergo risk assessment process before approval and placing the same in the market.  The  absence  of  safety  data  and  efficacy  data  regarding  the  product  will hamper grant of new product approval.

- (d) & (e): To reduce the burden of product approval and facilitate the clearance of new food products, FSSAI took various measures. These include:
- (i ) amendment to Regulation 2.12 on proprietary food under the Food Safety and Standards (Food Products and Food Additives) Regulations, 2011.

This amendment shifted the clearance of new foods from recipe based approach to the ingredient based approach on the principles that a food would be safe for human consumption if the standardized ingredients are used in preparation of such food. This has resulted in a drastic reduction in the need of product approval.

- (ii) The list of permissible food additives has also been increased under these regulations. In addition, several new product standards/regulations have also been developed.
- (iii) The Food Safety and Standards (Food or Health Supplements, Nutraceuticals, Foods for Special Dietary Uses, Foods for Special Medical Purpose, Functional Foods and Novel Food) Regulations, 2016 covering eight categories of food, namely, Health Supplements, Nutraceuticals, Foods for Special Dietary Uses, Foods for Special Medical Purposes, Specialty Foods containing plants or botanicals, Foods containing probiotics, Foods containing prebiotics and  Novel  Foods  have  been  notified  which  has  further  reduced  the  need  for  any  product approval.
- (iv) A separate Expert Committee has been constituted to examine the applications received under the Food Safety and Standards (Approval of non- specified food and food ingredients) Regulations, 2017 to facilitate and expedite the process of approval.

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