Draft Food Safety and Standard Rules, 2011 published on 19.1.2011
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
New Delhi, dated the 19th January, 2011
G.S.R. 39(E) — The following draft Food Safety and Standard Rules, 2011 which the central Government proposes to make,
in exercise of the powers conferred by section 91 of Food Safety and Standards Act, 2006 (34 of 2006), read with the
sections 5, 7, 30, 36, 37, 38, 39, 40, 41, 43, 45, 46, 47, 68, 70, 71, 73, 74, 75, 76, 77, 78, 81, 82, 83 and 84, the notification of the
Government of India no SO 1855 (E) dated 29th July, 2010, is hereby pre-published for the information of the persons likely
to be affected thereby; and notice is hereby given that the said draft will be taken into consideration after expiry of a period
of 30 days from the date of this Gazette notification is made available to the public.
Objections or suggestions, if any, may be addressed to the CEO, Food Safety and Standards Authority of India,
FDA Bhawan, Kotla road, New Delhi – 110002
Any objections or suggestions which may be received from any person in respect of the said draft before the date
so specified will be taken into consideration by the Central Government.
DRAFT FOOD SAFETY AND STANDARDS RULES, 2011
1.1: Title and commencement
1.1.1: These rules may be called the Food Safety and Standards Rules, 2010.
1.1.2: They shall come into force on the date of their publication in the official Gazette.
1.2.1: In these rules, unless the context otherwise requires,
1. “Act” means the Food Safety and Standards Act, 2006 (Act 34 of 2006) ;
2. “Adjudicating Officer” means the Adjudicating Officer appointed under sub-section (1) of section 68 of the
3. “Advocate” means a person who is entitled to practice the profession of law under the Advocates Act, 1961
(25 of 1961)
4. “Appellate Tribunal” means the Food Safety Appellate Tribunal constituted under section 70 of the Act.
5. “Authorised Officer” means an officer authorized by the Food Authority referred in the sub-section (5) of
section 47 of the Act.
6. “Inquiry” means the inquiry referred to in section 68.
7. “Licensing Authority” means the Designated Officer appointed under section 36 of the Act for the local area
and includes any other officer so appointed for the purpose of granting license by the Commissioner of Food Safety
8. “Notified laboratory” means any of the laboratories notified by the Food Authority under sub-sections (1)
and (2) of section 43 of the Act.
9. “Presiding Officer” means a person appointed as Presiding Officer of the Appellate Tribunal under section
70 of the Act.
10. “Referral laboratory” means any of the laboratories established and/or recognized by the Food Authority
by notification under sub section (2) of section 43 of the Act.
11. “Registrar” means the Registrar of the Appellate Tribunal and includes an officer of such Appellate
Tribunal who is authorized by the Presiding Officer to function as Registrar
12. “Registry” means the registry of the Appellate Tribunal
13. “Rules” means the Food Safety and Standards Rules, 2010.
38 THE GAZETTE OF INDIA EXTRAORDINARY [PART II—SEC. 3(i)]
ENFORCEMENT STRUCTURE AND PROCEDURES
2.1 – Qualification and duties
2.1.1: Commissioner of Food Safety:
1. Qualification: No person below the rank of Commissioner and Secretary to State Government shall be
eligible to be appointed as the Commissioner of Food Safety.
2. Powers and Duties: Powers and duties of the Commissioner of Food Safety shall be as provided in the
section 30 (2) of Food Safety and Standards Act, 2006.
2.1.2: Designated Officer
(i) The Designated Officer shall be a whole time Officer, not below the rank of Sub-Divisional Officer or
equivalent and shall possess degree in Science or at least one of the educational qualifications prescribed for
the Food Safety Officer under these Rules.
(ii) Notwithstanding anything mentioned above, persons having been appointed as food Inspector
having qualification prescribed under the PFA Rules, 1955 or Local Health Authority shall be eligible for
appointment as Designated Officer, subject to fulfilling such other conditions as may be prescribed for the
post of Designated Officer by the State Government; and
(iii) Undergo training as may be specified by the Food Authority, within a period of two years.
1. Powers and duties:
(i) The powers and duties of the Designated Officer shall be as mentioned in section 36 (3) of FSS Act,
(ii) The Designated Officer shall, in addition to the powers specified in Section 36 (3) of FSS Act, 2006,
also ensure the refund of fee for analysis paid by the purchaser as per the provision of Section 40 (1), besides
the cost of the sample
(iii) The Designated Officer shall ensure the timely disposal of redundant samples, in the manner
contemplated for the seized materials, in consultation with Commissioner of Food Safety
(iv) Without prejudice to anything contained in the aforesaid Rules, the Designated Officer shall have
all administrative powers which may include suspension, cancellation or revocation of the license of the Food
Business Operator in case any threat or grave injury to public, has been noticed in the report of the Food
Provided that while taking such administrative action the procedure described in the Act and Regulations
shall be followed.
2.1.3: Food Safety Officer
1. Qualification: Food Safety Officer shall be a whole time officer and shall, on the date on which he is so appointed possesses the following:
(i) a degree in Food Technology or Dairy Technology or Biotechnology or Oil Technology or Agricultural Science or Veterinary Sciences or Bio-Chemistry or Microbiology or Masters Degree in Chemistry from a
recognized University, or
(ii) any other equivalent/recognized qualification notified by the Central Government, or
(iii) graduate in medicine and has received training in food safety, sampling and surveillance approved
for the purpose by the Central Government or State Government; and
(iv) has successfully completed training, for a specified period in food safety, food inspection and sampling under an Institute or Institution approved for the purpose by the Food Authority.
Provided that, on the date of commencement of these Rules, a person who has already been appointed as a Food Inspector under the provisions of Prevention of Food Adulteration Act, 1954, may perform the duties of the Food Safety Officer if notified by the state/Central government if the officer fulfils such other conditions as may be
prescribed for the post of Food Safety Officer by the State Government.
Provided further that the State Government may, in cases where a Medical Officer of health administration of
local area has been performing the function of food Inspector under the Prevention of Food Adulteration Act, 1954,
assign the powers and duties of Food Safety Officer to such Medical Officer in charge of health administration of that area.
Provided also further that no person who has any financial interest in the manufacture, import or sale of any
article of food shall be appointed to be a Food Safety Officer under this rule Provided also further that he/she shall undergo a specialized training laid down by the Food Authority within
a period of two years from the commencement of these rules.
2. Powers and Duties:
(i) Without prejudice to the powers conferred on him under section 38 of the Act, where the Food Safety
Officer is of the opinion or he has reason(s) to be recorded in writing that in the given situation it is not possible to
comply with the provision of section 38 (1) (c) or the proviso to section 38(1) for reasons like non availability of the
Food Business Operator, the Food Safety Officer may seize the adulterant or food which is unsafe or sub-standard
or mis-branded or containing extraneous matter, may seal the premises for investigation after taking a sample of
such adulterant or food for analysis.
(ii) Where the Food Safety Officer is of the opinion or he has reason(s) to believe that any person engaged in
selling, handling or manufacturing any article of food is suffering from or harbouring the germs of any infectious
disease, he may cause such person to be examined by a qualified medical professional duly authorized by the
Provided that where such person is a female, she shall be examined by a qualified lady medical professional
duly authorized by the Designated Officer.
If on such examination the qualified medical professional certifies that such person is suffering from any such
disease, the Designated Officer, on the recommendation of the Food Safety Officer may by order in writing direct
such person not to take part in selling or manufacturing any article of food.
Provided further that in emergency, in the interest of public health, the Food Safety Officer may direct such
person to suspend food related operations, while informing the Designated Officer simultaneously.
(iii) Furthermore, it shall be the duty of the Food Safety Officer
(a) To inspect, as frequently as may be prescribed by the Designated Officer, all food establishments
licensed for manufacturing, handling, packing or selling of an article of food within the area assigned to him;
(b) To satisfy himself that the conditions of licenses are being complied with by each of the Food
Business Operators carrying on business within the area assigned to him and report to the Designated
(c) To procure and send for analysis if necessary, samples of any article of food which he has reason to
suspect are being manufactured, stocked or sold or exhibited for sale in contravention of the provisions of the
Act, or rules and regulations framed thereunder
(d) To draw samples for purposes of surveillance, survey and research, which shall not be used for
(e) To investigate any complaint which may be made to him in writing in respect of any contravention of
the provisions of the Act, or rules framed thereunder;
(f) To maintain a data base of all Food Business within the area assigned to him;
(g) To recommend issue of improvement notices to the Food Business Operator whenever necessary;
(h) To maintain a record of all inspections made and action taken by him in the performance of his duties,
including the taking of samples and seizure of stocks, and to submit copies of such records to the Designated
Officer as directed in this regard;
(i) To make such inquiries and inspections as may be necessary to detect the manufacture, storage or
sale of articles of food in contravention of the Act or rules framed thereunder;
(j) To stop and inspect any vehicle suspected to contain any unsafe food or food which does not
comply with the provisions of this Act and rules, intended for sale or delivery for human consumption;
(k) To recommend to the Designated Officer giving specific grounds, suitable action in regard to licenses
issued to any Food Business Operator, if on inspection the Food Safety Officer finds that the Food Business
Operator had violated the conditions for grant of license;
(l) To carry out food safety surveillance to identify and address the safety hazards
(m) To respond to incidents of food poisoning in his area and to send report to and assist the Designated
Officer to enable him to initiate corrective action;
(n) To facilitate preparation of Food safety plans for Panchayat and Municipalities in accordance with
the parameters and guidelines given in Schedule IV of Chapter 3 of Regulations.
(o) To detain imported packages which are suspected to contain articles of food, the import or sale of
which is prohibited;
(p) To coordinate with the Food Business Operators within his area of operation and facilitate the
introduction of food safety systems by the Food Business Operators.
(q) To perform such other duties, as may be entrusted to him by the Designated Officer or Food Safety
Commissioner having jurisdiction in the local area concerned.
2.1.4: Food Analyst
1. Qualification: A person shall not be qualified for appointment as Food Analyst under the Act unless she/
(i) Holds a Master’s degree in Chemistry or Biochemistry or microbiology or Dairy Chemistry or Food
Technology, Food and Nutrition or holds Bachelor of Technology in Dairy/Oil or holds degree in 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 recognized and notified by the Central government for such purposes and has not
less than three years experience in the analysis of food; and
(ii) Has been declared qualified for appointment as a Food Analyst by a board appointed and notified by
Notwithstanding the above, any person who has been declared qualified for appointment as
Public Analyst by the board constituted under Prevention of Food Adulteration Act, 1954 shall be
eligible for holding the post of Food Analyst.
Provided that a person who is a Public Analyst under the provisions of Prevention of Food
Adulteration Act, 1954 on the date of commencement of these Rules, may hold office of the Food
Analyst subject to the terms and conditions of service applicable to him/her even though he/she does
not fulfill the qualification prescribed above.
(i) The Food Analyst shall analyse or cause to be analysed the article of food sent to him for analysis.
In analyzing the article of food, the Food Analyst shall follow such instructions and shall adhere to such
procedure as adopted by the Food Authority from time to time. The report of analysis shall be signed by the
(ii) After completion of analysis of article of food, the Food Analyst shall send his report to the Designated
Officer, the Purchaser of article of food, as the case may be, in Form VII A.
2.2 – Procedure of taking extracts of documents and matters connected therewith
2.2.1: Manner of taking extracts
1. Where the Food Safety Officer has seized any books of account and other documents in exercise of powers
conferred upon him under sub-section (6) of section 38 of the Act, he shall return the same to the person from whom
they were seized within a period not exceeding thirty days from the date of such seizure
Provided that before returning the books of account and other documents, the Food Safety Officer shall be
entitled for copies thereof or extracts there from, as the case may be.
2. On receipt of such communication from the Food Safety Officer, the person from whom the books of
account and documents were seized shall provide the copies or extracts as the case may be, duly authenticated by
the Food Business Operator.
3. The extracts shall be taken by the Food Safety Officer or by any person authorized by him.
4. The person making the extracts shall not in any manner cause dislocation, mutilation, tampering or damage
to the records in the course of making extracts.
5. The person making extracts shall not make any marking on any record or paper.
1. The extracts or the copies referred to in Rule 2.2.1 above, shall be initialled on each page of such extracts
or copies by the person from whom the books of account and other documents were seized and such extracts or
copies so authenticated shall be provided to the Food Safety Officer, accompanied by an Affidavit in Form I of the
person from whom the books of account and other documents were seized, certifying the authenticity of such
extracts or copies.
2.3 – Seizure of articles of food by the Food Safety Officer and matters connected therewith
2.3.1.: Form of receipt for article of food seized by a Food Safety officer– For every article of food seized
under clause (b) of sub-section 1 of Section 38 of the Act, a receipt in Form II shall be given by the Food Safety
Officer to the person from whom the article of food was seized.
2.3.2 Form of order/bond not to dispose of the stock: Where the Food Safety Officer keeps any article of food
in the safe custody of the Food Business Operator under clause (c) of sub-section (1) of Section 38 of the Act.
1. he shall, after affixing the seal, on the article of food, make an order to the Food Business Operator in
Form III and the Food Business Operator shall comply with such an order, and
2. he may require the Food Business Operator to execute a bond in Form IV.
2.4: Sampling and Analysis
2.4.1: Procedure for taking sample and manner of sending it for analysis –
The Food Safety Officer while taking sample of food for analysis under clause A of Sub Section 1 of Section
38 and Section 47 (except 47 (5)) of the Act, shall also follow the procedure specified hereunder, namely ;-
1. Ensure the presence of at least two witnesses at the time of lifting of the samples
2. Obtain the signatures from the witnesses in all the forms and documents prepared
3. Serve the notice in Form V A to the business operator then and there
4. in case the food business operator discloses that the product has been obtained from the manufacturer,
the distributor or supplier, a notice shall be given to such manufacturer, distributor or supplier,
5. in case where the sample is drawn from an open container, the person drawing the sample shall also
draw a sample from a container in original condition of the same article bearing the same declaration, if such
container is available, and intimate the same to the Food Analyst.
6. Where a Food Safety Officer or the purchaser takes a sample of an article of food for analysis, he shall
pay, the cost of such sample, to the person from whom the sample is taken, calculated at the rate at which the
article is sold to the public.