Lok Sabha Question No. 4535 (UNSTARRED), answered on 2019-07-19
Subject: Regulation under Food Safety and Standards Act
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Shashi Tharoor

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA UNSTARRED QUESTION NO. 4535 TO BE ANSWERED ON 19 TH JULY, 2019

## REGULATION UNDER FOO D SAFETY AND STANDAR DS ACT

## 4535. DR. SHASHI THAROOR:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

(a)  whether  the  Government  has  notified  all  regulations  as  required  by  the  Food  Safet Standards Act, if so, the details thereof and if not the reasons therefor along with t y which the said regulations is likely to be notified;

(b)  whether  the  Government  is  aware  that  majority  of  Food  Business  Operators  have  lic despite incomplete documentation;

(c) if so, whether the Government has taken steps to review, cancel or rei ssue these licenses and if so, the details thereof;

(d) whether the Government is aware that majority of State Food Laboratories (SFL) are accredited by National Accreditation Board for Testing and Calibration Laboratories; and

(e) if so, whether the Government has taken steps to accredit these SFLs, if so, the details t and if not, the reasons therefor?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE

## (SHRI ASHWINI KUMAR CHOUBEY)

(a): Government has notified all major regulations and guidelines required in implementa of Food Safety and Standards Act , 2006 which are detailed at Annexure .

(b) &(c): The  Food  Business  Operators,  while  applying  for  Food  Safety  and  Standards Authorityof  India  (FSSAI)  license  are  required  to  submit  certain  mandatory  documents prescribed under Annexure - 2 of Food Safety and Standards (Licensing and Registration of Food Businesses)  Regulations,  2011  as  applicable  to  their  Kind  of  Business(es).  The  Lice sing Authorities responsible for issuance of State/Central License issuelicense after verification of the documents submitted by the Food Business Operators.

(d)& (e):  Yes.  A  Central  Sector  Scheme  for  'Strengthening  of  Food  Testing  System  in  the Country Including  Provision  of  Mobile  Food  Testing  Labs'  has  been  rolled  out  by  the  Food Safety  and  Standards  Authority  of  India  (FSSAI)  with  an  outlay  of  Rs.  481.95  Crore  fo period 2016 - 17 to 2018 -19. One of the components of the Scheme is Capacity Building of Food Testing Laboratories so as to ensure that all the State Food Testing laboratories atta accreditation  and  bring  them  at  par  with  international  standards.  So  far,  8  Capacity Programs  have  been  organised  in  different  locations  so  as  to cover  all  State  Food  Testing Laboratories in which 264 laboratory personnel have participated. A panel of experts ha been constituted and shared with States/UTs to help them about NABL accreditation proc This  has  raised  the  total  number  of  NABL accredited  State  Food  Testing  Laboratories from 8 to 16.

## AREAS OF REGULATIONS UNDER THE FOOD SAFETY AND STANDARDS ACT, 2006

## 1. Regulations framed

| Section 92 (2) of the Act   | Section 92 (2) of the Act   | Section 92 (2) of the Act                                                                                                           | Related Regulations framed                                                                                                                           |
|-----------------------------|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sr. No.                     | Reference Section           | Suggested areas                                                                                                                     | and notified.                                                                                                                                        |
| 1.                          | 92 (2) (a)                  | Salaries and other conditions of service of officers and other employees of the Food Authority under sub-section (3) of section 9;  | Food Safety and Standards Authority of India (Salary, Allowances and other Conditions of service of Officers and Employees) Regulations, 2013        |
| 2.                          | 92 (2) (b)                  | Rules of procedure for transaction of business under subsection (5) of section 11                                                   | Food Safety and Standards Authority of India (Procedure for Transaction of Business of Central Advisory Committee) Regulations, 2010. (2 Amendments) |
| 3.                          | 92 (2) (c)                  | Other functions of Central Advisory Committee under sub-section (2) of section 12                                                   | Food Safety and Standards Authority of India (Procedure for Transaction of Business of Central Advisory Committee) Regulations, 2010. (2 Amendments) |
| 4.                          | 92 (2) (d)                  | Procedure of Scientific Committee and Panels under subsection (4) of section 15;                                                    | Food Safety and Standards (Transaction of Business and Procedures for the Scientific Committee and Scientific Panels) Regulations, 2016              |
| 5.                          | 92 (2) (e)                  | Notifying standards and guidelines in relation to articles of food meant for human consumption under sub-section (2) of section 16; | Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. (57 Amendments)                                            |
| 6.                          | 92 (2) (f)                  | Procedure to be followed by Food Authority for transaction of business at its meeting under sub- section (1) of Section 17          | Food Safety and Standards (Transaction of Business) Regulations, 2010.(1 Amendment)                                                                  |
| 7.                          | 92 (2) (h)                  | Limits of additives under section 19;                                                                                               | Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011                                                             |
| 8.                          | 92 (2) (i)                  | Limits of quantities of contaminants, toxic substance and heavy metals etc. Under section 20;                                       | Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011. (14 Amendments)                                                     |
| 9.                          | 92 (2) (j)                  | Tolerance limit of pesticides, veterinary drugs residues, etc under section 21;                                                     | Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011. (14 Amendments)                                                     |
| 10.                         | 92 (2) (k)                  | The manner of marking and labelling of foods under section 23;                                                                      | Food Safety and standards (Packaging and Labeling) regulation, 2011. (8 Amendments) Revised Food Safety and Standards (Labelling and Display)        |

| Section 92 (2) of the Act   | Section 92 (2) of the Act   | Section 92 (2) of the Act                                                                                                                                                                                                                             | Related Regulations framed                                                                                                               |
|-----------------------------|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Sr. No.                     | Reference Section           | Suggested areas                                                                                                                                                                                                                                       | and notified. Regulations, 2019 has beendraft                                                                                            |
| 11.                         | 92 (2) (l)                  | Form in which guarantee shall be given under sub-section (4) of section 26;                                                                                                                                                                           | Food Safety and Standards (Licensing and Registration of Food Businesses) Regulation, 2011-covered under sub- regulation 2.1.14 (form E) |
| 12.                         | 92 (2) (m)                  | Conditions and guidelines relating to food recall procedures under subsection (4) of section 28;                                                                                                                                                      | Food Safety and Standards (Food Recall Procedure) Regulations, 2017                                                                      |
| 13.                         | 92 (2) (n)                  | Regulations relating to functioning of Food Safety Officer under subsection (5) of section 29;                                                                                                                                                        | Food Safety and Standards Rules, 2011                                                                                                    |
| 14.                         | 92 (2) (o)                  | Notifying the registering authority and the manner of registration; the manner of making application for obtaining license, the fees payable therefore and the circumstances under which such license may be cancelled or forfeited under section 31; | Food Safety and Standards (Licensing and Registration of Food Businesses) Regulation, 2011 (3 Amendments)                                |
| 15.                         | 92 (2) (p)                  | The respective areas of which the Designated Officer shall be in- charge for food safety administration under subsection (1) of section 36;                                                                                                           | Orders issued by FSSAI and State Authorities from time to time for respective areas.                                                     |
| 16.                         | 92 (2) (q)                  | Procedure in getting food analysed, details of fees etc., under sub-section (1) of section 40;                                                                                                                                                        | Food Safety and Standards (Laboratory and Sampling Analysis) Regulation, 2011, (1 Amendment)                                             |
| 17.                         | 92 (2) (r)                  | Functions, procedure to be followed by food laboratories under sub-section (3) of section 43;                                                                                                                                                         | Food Safety and Standards (Laboratory and Sampling Analysis) Regulation, 2011, (1 Amendment)                                             |
| 18.                         | 92 (2) (s)                  | Procedure to be followed by officials under sub-section (6) of section 47;                                                                                                                                                                            | Food Safety and Standards Rules, 2011 and Food Safety and Standards (Import) Regulations, 2017.                                          |
| Section of 22 the Act       | Section of 22 the Act       | Section of 22 the Act                                                                                                                                                                                                                                 | Related regulations framed and notified.                                                                                                 |
| Sr. No.                     | Reference Section           | Suggested areas                                                                                                                                                                                                                                       | Related regulations framed and notified.                                                                                                 |
| 19.                         | 22(1)                       | Foods for special dietary uses or functional foods or Nutraceuticals                                                                                                                                                                                  | Food Safety and Standards (Health Supplements,                                                                                           |

| Section 92 (2) of the Act   | Section 92 (2) of the Act   | Section 92 (2) of the Act                                                                                                                                                                                                         | Related Regulations framed                                                                                                                                                                                                                                                                                                                                                        |
|-----------------------------|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sr. No.                     | Reference Section           | Suggested areas                                                                                                                                                                                                                   | and notified.                                                                                                                                                                                                                                                                                                                                                                     |
|                             |                             | or health supplements                                                                                                                                                                                                             | Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016                                                                                                                                                                                                                                                 |
| 20.                         | 22(2)                       | Genetically engineered or modified food                                                                                                                                                                                           | Food Safety and Standards (Genetically Modified and Engineered Foods) Regulations, 2019 (Currently under process of draft notification)                                                                                                                                                                                                                                           |
| 21.                         | 22(3)                       | Organic Food                                                                                                                                                                                                                      | Food Safety and Standards (Organic Food) Regulations, 2017                                                                                                                                                                                                                                                                                                                        |
| 22.                         | 22(4)                       | Proprietary and Novel food                                                                                                                                                                                                        | Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011. Food Safety and Standards (Health Supplements, Nutraceuticals, and Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016. Food Safety and Standards (Approval for non-specified food and food ingredients) Regulations, 2017 |
| Section 16 (2) of the Act   | Section 16 (2) of the Act   | Section 16 (2) of the Act                                                                                                                                                                                                         | Related Regulations framed                                                                                                                                                                                                                                                                                                                                                        |
| Sr. No.                     | Reference Section           | Suggested areas                                                                                                                                                                                                                   | and notified.                                                                                                                                                                                                                                                                                                                                                                     |
| 23.                         | 16(2) (a)                   | The standards and guidelines in relation to articles of food and specifying an appropriate system for enforcing various standards notified under this Act;                                                                        | [Remarks: Area already covered in Section 92(2)(e)]                                                                                                                                                                                                                                                                                                                               |
| 24.                         | 16 (2) (b)                  | The limits for use of food additives, crop contaminants, pesticide residues, residues of veterinary drugs, heavy metals, processing aids, myco-toxins, antibiotics and pharmacological active substances and irradiation of food; | [Remarks: Already covered in Sections 92(2)(h), 92(2)(i) and 92(2)(j)]                                                                                                                                                                                                                                                                                                            |
| 25.                         | 16 (2) (c)                  | The mechanisms and guidelines for accreditation of certification bodies engaged in certification of food safety                                                                                                                   | Food Safety and Standards(Food Safety Auditing) Regulations, 2018                                                                                                                                                                                                                                                                                                                 |

| Section 92 (2) of the Act   | Section 92 (2) of the Act   | Section 92 (2) of the Act                                                                                                 | Related Regulations framed and notified.                                                                                                                                                                                  |
|-----------------------------|-----------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sr. No.                     | Reference Section           | Suggested areas                                                                                                           | Related Regulations framed and notified.                                                                                                                                                                                  |
|                             |                             | management systems for food businesses;                                                                                   |                                                                                                                                                                                                                           |
| 26.                         | 16 (2) (d)                  | The procedure and the enforcement of quality control in relation to any article of food imported into India               | Food Safety and Standards (Import) Regulations, 2017. (1 Amendment)                                                                                                                                                       |
| 27.                         | 16 (2) (e)                  | The procedure and guidelines for accreditation of laboratories and notification of the accredited laboratories;           | Food Safety and Standards(Recognition and Notification of Laboratories) Regulations, 2018.                                                                                                                                |
| 28.                         | 16 (2) (f)                  | The method of sampling, analysis and exchange of information among enforcement authorities;                               | Food Safety and Standards Rules, 2011. Manuals of the Methods of Analysis and Sampling approved by the Food Authority                                                                                                     |
| 29.                         | 16 (2) (h)                  | Food labelling standards including claims on health, nutrition, special dietary uses and food category systems for foods; | [Remarks: Labelling already covered in Section 92(2)(k)] Food Safety and Standards (Advertising and Claims) Regulations, 2018 and Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011 |

## 2.  Regulations not framed

| Sections 16 and 92 of the Act   | Sections 16 and 92 of the Act   | Sections 16 and 92 of the Act                                                                                                                 | Remarks                                                                                                                                                                                                                                       |
|---------------------------------|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sr. No.                         | Reference Section               | Suggested areas                                                                                                                               |                                                                                                                                                                                                                                               |
| 30.                             | 16 (2) (g)                      | Conduct survey of enforcement and administration of this Act in the country                                                                   | Regulations need not to be framed as this section envisaging about the process of conducting survey of enforcement and administration of this Act in the country. The same is proposed to be deleted in the proposal of amendment in the Act. |
| 31.                             | 92 (2) (g)                      | Making or amending regulations in view of urgency concerning food safety or public health under clause (d) of sub- section (2) of section 18. | The Law Ministry suggested that there is no necessity to frame regulations under this clause as the power has already been given in section 18 (2) (d).                                                                                       |
| 32.                             | 92 (2) (t)                      | Financial regulations to be adopted by the Food Authority                                                                                     | This would be taken up after amendment of the Act so as to                                                                                                                                                                                    |

| in drawing up its budget under sub-section (2) of section provide for creation of   | corpus.   |
|-------------------------------------------------------------------------------------|-----------|

## 3. Regulations framed in other areas

| Sections 16 and 92 of the Act   | Sections 16 and 92 of the Act   | Sections 16 and 92 of the Act                                                                                                                | Remarks                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          |
|---------------------------------|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sr. No.                         | Reference Section               | Suggested areas                                                                                                                              |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |
| 33.                             | 92 (2) (v)                      | Any other matter which is required to be, or may be, specified by regulations or in respect of which provision is to be made by regulations. | Food Safety and Standards (Prohibition and Restriction for sale) Regulations, 2011. (5 Amendments) Food Safety and Standards (Approval for non-specified food and food ingredients) Regulations, 2017 Food Safety and Standards (Packaging) Regulations, 2018 Food Safety and Standards (Recovery and Distribution of Surplus Food) regulations, 2019 (currently under process of final notification) Food Safety and Standards (Safe and Wholesome Food for School Children) Regulations, 2019. (currently under process of draft notification) |

## 4. Guidelines/ orders issued

| Sections 16 and 92 of the Act   | Sections 16 and 92 of the Act   | Sections 16 and 92 of the Act                                                                                                                     | Related guidelines/ Orders framed and notified.                                                                                                                                                                                |
|---------------------------------|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sr. No.                         | Reference Section               | Suggested areas                                                                                                                                   |                                                                                                                                                                                                                                |
| 34.                             | 16 (2) (i)                      | The manner in which and the procedure subject to which risk analysis, risk assessment, risk communication and risk management shall be undertaken | Manual for development of food regulations have been framed. FSS (Import) Regulations, 2017. Covers Risk Management system in Food import clearance (Operational in ICEGATE)                                                   |
| 35.                             | 92 (2) (u)                      | Issue guidelines or direction for participation in Codex meeting and preparation of response to Codex matters;                                    | Guideline for preparation of national response or national view point to codex and participation in codex meeting & guidelines for codex contact point, national codex committee, and nation shadow committee issued by FSSAI. |