Food Safety and Standards (First Amendment) Rules, 2022

MINISTRY OF HEALTH AND FAMILY WELFARE

(Department of Health and Family Welfare)

NOTIFICATION

New Delhi, the 16th January, 2023

G.S.R. 33(E).—Whereas in exercise of the powers conferred by section 91 of Food Safety and Standards Act, 2006 (34 of 2006), the draft of certain rules, namely, the Food Safety and Standards (First Amendment) Rules, 2020, was published vide notification of the Government, of India, Ministry of Health and Family Welfare vide number G.S.R. 535(E), dated the 27th August, 2020, in the Gazette of India, Extraordinary, Part II, Section 3, Sub­section (i), inviting objections and suggestions from persons likely to be affected thereby, within a period of thirty days from the date on which the copies of the Official Gazette containing the said notification were made available to the public;

And whereas the copies of the said Official Gazette were made available to the public on the 27th August, 2020;

And whereas the objections and suggestions received from the public in respect of the said draft regulations have been considered by the Central Government;

Now, therefore, in exercise of the powers conferred by section 91 of the said Act, the Central Government hereby makes the following rules further to amend the Food Safety and Standards Rules, 2011, namely: –

1. (1) These rules may be called the Food Safety and Standards (First Amendment) Rules, 2022.

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

2. In the Food Safety and Standards Rules, 2011(hereinafter to be referred as the said rules), in rule 2.1, –

1. in sub-rule 2.1.2 relating to ‘Designated Officer’, –

(a) in clause 1 relating to qualification, –

(i) for sub-clause (i), the following clause shall be substituted, namely: –

“(i) The Designated Officer shall be a whole time Officer, not below the rank of Sub-Divisional Officer or equivalent and shall possess a Bachelor’s or Master’s or Doctorate degree in Science with chemistry as one of the subjects or shall possesses at least one of the educational qualifications prescribed for the Food Safety Officers under these rules or who has possessing not less than five years of experience as Food Safety Officers or has not less than seven years combined experience as Food Safety Officer and Food Inspector of which minimum four years as Food Safety Officer after commencement of the Food Safety and Standards Act:

Provided that the Commissioner of Food Safety may with the previous approval of the State Government, confer a Sub-Divisional Officer of the area, additional charge as Designated Officer for same period as may be specified by the Food Authority.

Provided further that the Chief Executive Officer may confer any officer of the Central Government with additional charge as Designated Officer for the area outside the jurisdiction of State Government or Union territory Government”

(ii) sub-clause (ia) shall be omitted;

(iii) in sub-clause (ii), the proviso shall be omitted;

(iv) in sub-clause (iii), in item (a), after the words “as Local Health Authority”, the words “or appointed as Food Safety Officer having qualification prescribed under these rules” shall be inserted;

(b) in clause 2 relating to powers and duties, the sub-clause (iia) shall be omitted;

(2) in sub-rule 2.1.3 relating to ‘Food Safety Officer’,-

(a) in clause 1 relating to qualification, –

i. for sub-clause (i), the following shall be substituted, namely:-

“(i) a Bachelor’s or Master’s or Doctorate degree in Food Technology or Dairy Technology or Biotechnology or Oil Technology or Agricultural Science or Veterinary Sciences or Bio-Chemistry or Microbiology or Chemistry or medicine from a recognized University, or”

ii. in sub-clause (ii), for the words “notified by the Central Government,” the words “notified by the Food Authority with the prior approval of the Central Government,” shall be substituted.

(b) in clause 4 relating to powers and duties, in sub-clause (iii), after item (d), the following sub-clause shall be inserted, namely: –

“(dd) examine the label of any article of food to be sent for analysis in accordance with the requirements of labelling, advertisement and claims as specified in the regulations made under the Food Safety and Standards Act and send the report of non-compliance, if found, to the Designated officer for scrutiny so as to take further proceedings as per the provisions of the Food Safety and Standards Act, or rules made thereunder.”

(3) in sub-rule 2.1.4 relating to ‘Food Analyst’, in clause 1 relating to qualification, for sub-clause (i), the following shall be substituted, namely:-

“(i) holds a Bachelor’s or Master’s or Doctorate degree in Chemistry or Biochemistry or microbiology or Dairy Chemistry or Agriculture Science or Animal Science or Fisheries Science or Biotechnology or Food safety or Food Technology, Food and Nutrition or Dairy Technology or Oil Technology or Veterinary Sciences from a university established in India by law or is an associate of the Institution of Chemists (India) by examination in the section of Food Analysts conducted by the Institution of Chemists (India) or any other equivalent qualification notified by the Food Authority with the prior approval of the Central Government and has not less than three years’ experience in the analysis of food; and”

(4) In the said rules, in rule2.4 relating to ‘Sampling and analysis,-

(a) in sub-rule 2.4.1 relating to Procedure for taking sample and manner of sending it for analysis, –

(i) after clause 7, the following clause shall be inserted;

“7(a) Mask all the information relating to the Food Business Operator in the label of the sample including brand or trade name and bar code suitably and provide a code number.”

(ii) in clause 8, after the words “containing the samples” the words “and prepackaged samples” shall be inserted.

(iii) in clause 9, after sub-clause (i), the following proviso shall be inserted, namely, –

“Provided that, in case of samples drawn for microbiological analysis, surveillance, import clearance, investigation of complaint and food safety emergency response, the requirement of four parts of a samples shall not apply and number of parts of a samples for such condition shall be as specified in the following Table.

TABLE

S.No.	Condition of sampling	Number of parts of samples
1	Microbiological analysis	As specified in Appendix B of Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011
2	Surveillance	As per the surveillance plan by the Food Authority or State Food Authority.
3	Import clearance	As specified in the Food Safety and Standards (Food import) Regulations, 2017.
4	Food safety emergency incidents	Less than the mandated number of parts of the sample subject to reasons along with the evidence to be recorded in writing.
5	Any other cases	Less than the mandated number of parts of the sample subject to reasons along with the evidence to be recorded in writing”

(b) in sub-rule 2.4.2,-

(i) in clause (2)for “Central/State Government,” the words “ Food Authority” shall be substituted.

(ii) for clause 7, the following shall be substituted, namely: –

“7. The manual of the method of analysis, as amended or adopted by the Authority from time to time, shall be used for analysing the samples of food articles, provided that in case the method for analysing any parameter is not available in the manual, the Food Laboratory may adopt a validated method of analysis prescribed by AOAC/ International Organization for Standardization (ISO) / Pearson’s/ Jacob/ International Union of Pure and Applied Chemistry/ Food Chemicals CODEX/ Bureau of Indian Standards/ Woodmen/ Winton-Winton/ Joslyn or any other internationally recognized regulatory agencies.”.”

(5) in sub-rule 2.4.6 relating to Appeal to the Designated Officer, after clause 2, the following clause shall be inserted, namely: –

“3. The certificate of analysis in the Form XI duly signed by the Director of the Referral Laboratory shall be forwarded within fourteen days of receipt of sample :

Provided that in case the Referral Laboratory is unable to analyse the sample within fourteen days of its receipt, the Referral Laboratory shall inform the Designated Officer and the Commissioner of Food Safety giving reasons and specifying the time to be taken for analysis.”

(6) for Form VA , the following Form shall be substituted, namely:-

“FORM V A

(See rule 2.4.1. (3))

Form of Notice to the Food Business Operator

To………………………………………

Dear Sir/s/ Madam:

I have this day taken the samples of food from premises/shop/market of……………………….. situated at……………………….. as specified below to have the same analysed by the Food Analyst for _______.

Details of food:

Batch number if available:

Parameter to be tested:

1. As per the Food Safety and Standards Authority of India Standards for the specific products

2. Any additional test to be performed if any

Place: (Sd/-) Food Safety Officer/
Date: Authorized
Officer.

Address:

Acknowledgement:

Sign of Food Business Operator

Witnesses

Witnesses”

(7) for Form VI , the following Form shall be substituted, namely:-

“FORM VI

(See rule 2.4.1(11))

MEMORANDUM TO FOOD ANALYST

Date: _____

From: ……………..

……………..

To

Food Analyst

………………
……………..

MEMORANDUM

(See rule 2.4.1(11))

1. The sample specified below is being forwarded herewith for analysis under ___ of ___ of section ____ of Food Safety and Standards Act, 2006 (34 of 2006).

(i) Code Number

(ii) Date of collection

(iii) Name, Nature of articles submitted for analysis

(iv) Name, Nature and quantity of preservative, if any, added to the sample.

(v) quantity and number of sample(vi) Special request with reason

(vii)any additional relevant information

(viii) Parameter to be tested (a) As per the Food Safety and Standards Authority of India Standards for the specific products (b) Any additional test to be performed if any

2. A copy of this memo and specimen impression of the seal used to seal the packet of sample are being forwarded separately by post or courier or hand delivery (strike out whichever is not applicable)

(Sd/) Food Safety Officer Address:

Address:”

(8) for Form VII A, the following Form shall be substituted, namely:-

“Form VII A

Report of the Food Analyst

[ See rule 2.4.2(5) and 2.4.4 (6)]

Report No._______.

Certified that I__ (name of the Food Analyst) duly appointed under the provisions of Food Safety and Standards Act, 2006 (34 of 2006), for _____ (name of the local area) received from _______* a sample of ____, bearing Code number and Serial Number _____ of Designated Officer of _____ area* on (date of receipt of sample) for analysis.

The condition of seals on the container and the outer covering on receipt was as follows:

I found the sample to be ………………….. (category of the sample) falling under Regulation No.____ of _____________ . The sample **was in a condition fit for analysis and has been analysed on _____ (give date of starting and completion of analysis) and the result of its analysis is given below/** was not in a condition fit for analysis for the reason given below:

……………………………………………………………………….

…………………………………….

Analysis report

(i) Sample Description

……………………………….

(ii) Physical Appearance

……………………………….

Sl. No.	Quality characteristics	Nature of method of test used	Result	Prescribed standards as per a. As per provisions of the Act, and the rules and regulations made thereunder b. As per label declaration for proprietary food
1.
2.
3.
4.
5.
6.

Opinion***

Signed this _____ day of ______ 20

(Sd/-) Food Analyst.

Address:

* Give the details of the senders

** Strike out whichever is not applicable

***When opinion and interpretation are included, document the basis upon which the opinions or interpretations have been made.

(9) After Form X , the following Form shall be inserted, namely:-

“FORM XI

(See rule 2.4.6(3))

CERTIFICATE OF ANALYSIS BY THE REFERRAL FOOD LABORATORY

Certificate No. ………………………….

Certificate that the sample , bearing number ……..purporting to be a sample/of……………… was received on…………………………………………………………………………………………………………………… with Memorandum No. ……….. Dated ………………. From …………. [Name of the Court] for analysis. The condition of seals on the container and the outer covering on the receipt was as follows:

I ………………………………………………………………………………………………………….. (name of the Director)_ …………………………………………. found the sample to be ………………………………………………………………….. (Category of food sample) ………………….. falling under Regulation No. of Food Safety and Standards(Food Products and Food Additive) Regulations, 2011. The sample was in a condition fit for analysis and has been analyzed on (Give date of starting and completion of analysis) . and the result of its analysis is given below /*was not in a condition fit for analysis for the reasons given below:—

Reason: —

……………………………………………………………………………………

Analysis Report: —

(i) Sample Description: — ……………………………………………………………………………………

(ii) Physical Appearance: — …………………………………………………………………………………….

(iii) Label: — …………………………………………………………………………

Sl.No.	Quality Characteristics	Characteristics Name of the Method of the test used Results Prescribed Standards as per:- (a) As per Food Safety and Standards (Food Products and Food Additive) Regulations, 2011 (b) As per label declaration for proprietary foods (c) As per the provisions of the Act and Regulations, for both above
1.
2.
3.
4.
5.
6.

Opinion **

Place:

(Signature)

Date:

Director Referral Food Laboratory

(Seal)

* Strike out whichever is not applicable.

** When opinion and interpretation are included, document the basis upon which the opinions/interpretations have been made.

[F. No.P.15025/13/2019-FR]

Dr. MANDEEP K. BHANDARI, Jt. Secy.

Note.- The principal rules were published in the Gazette of India, Extraordinary, Part-II, Section 3, Sub-section (i), vide notification number G.S.R. 362(E), dated the 5th May, 2011 and last amended vide notification number G.S.R. 1516(E), dated the 13th December, 2017.