The Food Safety and Standards Act, 2006
Food Safety and Standards (Food Recall Procudure) Regulation, 2017
The Food Safety and Standards Act, 2006
Official text
MINISTRY OF HEALTH AND FAMILY WELFARE
(Food Safety and Standards Authority of India)
NOTIFICATION
New Delhi, the 18th January , 2017
F. No. 1-59/FSSAI/2009.—Whereas the draft of the Food Safety and Standards (Food Recall Procedure)
Regulations, 2015, were published as required by sub-section (1) of 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. 1-
59/FSSAI/2009, dated the 22nd April 2015, 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 sixty 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 Gazette were made available to the public on the 29th May 2015;
And whereas the 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 (m) of sub-section (2) of section 92 read with sub-
section (4) of section 28 of the Food Safety and Standards Act, 2006, the Food Safety and Standards Authority of India
hereby makes the following Regulations, namely: -
Food Safety and Standards (Food Recall Procedure) Regulations, 2017.
CHAPTER-I
GENERAL
1. Short title and commencement.—(1) These regulations may be called as the Food Safety and Standards (Food
Recall Procedure) Regulations, 2017.
(2) They shall come into force on the date of their publication in the Official Gazette.
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) “food chain” for the purposes of these regulations includes food involved in manufacture, processing,
distribution, sale, import and export;
(c) “food recall” means the action to remove food from the market at any stage of the food chain, including
that possessed by consumers;
(d) “food recall plan” means the procedures and arrangements that a food business operator shall have in place
to retrieve food and food products from the food chain if a problem arises.;
(e) “food under recall” means the specific lot or batch or code number of food product that has been
determined by the Food Authority or the Commissioner of Food Safety of the State or Union territory or the
Food Business Operator as not in compliance with the Act or rules or regulations made thereunder;
(f) “recall alert” means any alert issued to the public by the Chief Executive Officer, Food Safety and
Standards Authority of India or the Commissioner of Food Safety of the State or Union territory or the Food
Business Operator under intimation to Chief Executive Officer, Food Safety and Standards Authority of
India and the concerned Commissioner(s) of Food Safety of the State(s) about the food under recall;
(g) “traceability” means the ability to follow the movement of a food article through specified stage(s) of its
production, processing and distribution;
(h) “unsafe food” means food as defined under clause (zz) of sub- section (1) of section 3 of the Act.
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(2) All other words and expressions used herein and not defined but defined in the Act, rules or regulations made
thereunder shall have the meanings assigned to the same in the Act, rules or regulations respectively.
CHAPTER-II
OBJECTIVES
3. Objectives of the food recall procedure.—(1) Ensure removal of food under recall from all stages of the food
chain in accordance with section 28 of the Act;
(2) ensure dissemination of information to concerned consumers and customers; and
(3) ensure retrieval, destruction or reprocessing of food under recall.
CHAPTER -III
SCOPE
4. Scope of the Food Recall Procedure.—These regulations shall apply to the food or food products that are determined
or prima facie considered unsafe and/or as may be specified by the Food Authority from time to time.
Explanation: Food articles which require the mandatory mention of statutory warnings related to consumption being
“injurious to health” may not be treated as unsafe food as part of any recall plan unless they are specifically determined
unsafe and injurious to health.
CHAPTER IV
FOOD RECALL PROCEDURE
5. Initiation of the food recall process.—(1) Every food business operator shall follow food recall procedure
including complete process of recall, post-recall report, and follow-up action in order to ensure the effectiveness
of the recall and prevent recurrence.
(2) The food business operator shall initiate a recall process to fulfill his responsibility in accordance with section 28
of the Act.
(3) The Chief Executive Officer, Food Safety and Standards Authority of India or the Commissioner of Food Safety
of the State or Union territory or both may direct the food business operator to initiate the recall process.
(4) The recall process shall also be initiated as a result of reports or complaints referred to the food business operator
from any stakeholder and if food business operator determines that there is a need to recall. In case the food
business operator does not respond to the complaint, the complainant or the consumer may inform the Chief
Executive Officer, Food Safety and Standards Authority of India or Commissioner of Food Safety of the State
or Union territory or both who will take steps to determine the need for recall and instruct the concerned food
business operator regarding the recall, who shall be bound by such instructions.
(5) It is the responsibility of all the food business operators in the entire food chain to implement the instructions
relating to food recall. Failure to do so shall render the food business operator liable to action as provided under
the Act or the rules or regulations made thereunder.
(6) When a food business operator refuses to undertake a recall directed by the Chief Executive Officer, Food Safety
and Standards Authority of India or Commissioner of Food Safety of the State or Union territory or where the
Chief Executive Officer, Food Safety and Standards Authority of India or Commissioner of Food Safety of the
State or Union territory has sufficient reasons to believe that additional measures would be required to make the
recall effective, or determines that a recall is ineffective, or has a reason to believe that unsafe food is continuing
to be manufactured by food business operator, the Chief Executive Officer, Food Safety and Standards Authority
of India or Commissioner of Food Safety of the State or Union territory will take appropriate action as provided
under the Act, rules or regulations made thereunder and the food business operator shall be liable for such action.
(7) A recall of imported food may also be initiated on the basis of reports of health and food authorities, or from
information received from such authorities or if it otherwise comes to the notice of the concerned authority.
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(8) The initiation of food recall shall not preclude the Chief Executive Officer, Food Safety and Standards Authority
of India or Commissioner of Food Safety of the State or Union territory from taking further regulatory action
against the concerned food business operator as may be required under the Act.
6. Operation of Food Recall System.—(1) The food business operator shall maintain the food distribution records
which include the names and addresses of suppliers and customers, nature of food, date of purchase, date of
delivery, lot number, batch code, pack size, brand name, date of manufacture, date of expiry and best before date,
and shall maintain such records for a period of one year from best before date or the expiry date, as applicable.
(2) In case of alcoholic beverages where declaration of best before date is exempted under food safety regulations,
one shall maintain records for a period of two years from date or month of supply from the manufacturer.
(3) The food business operator shall submit information as specified under Schedule I to the concerned Authority
immediately but not exceeding twenty-four hours from the time it comes to his notice that such food requires
recall in accordance with the provisions of these regulations and initiate the recall exercise, such information
alert(s) may be sent by quickest means of communication including fax, e-mail, and speed post. The
Commissioner of Food Safety of the State or Union territory shall inform the Chief Executive Officer, Food
Safety and Standards Authority of India within twenty-four hours of receipt of such information.
(4) The food business operator shall stop distribution of food under recall and also stop its production if necessary,
without waiting for any instructions from the Chief Executive officer, Food Safety and Standards Authority of
India or Commissioner of Food Safety of the State or Union territory so as to ensure that consumer safety is not
compromised and he shall contact everyone from the raw material vendor to the final consumer of the affected
food by written communication, phone, e-mail, fax, or a combination thereof, notify the suppliers and any other
relevant retailer or trade association and immediately identify all required product details along with any
additional details which would facilitate speedy identification and recall.
7. Food Recall plan.—(1) All food business operators engaged in the manufacture or importation or wholesale
supply of food regulated under the Act must have an up-to-date recall plan. The food retailers are not required to
have a food recall plan, unless they are also engaged in the manufacture or importation or wholesale supply of
food.
Provided that food businesses in the food service sector such as restaurants, caterers and takeaway joints are
exempted from having a recall plan unless they are running multi-outlet food business chains with integrated
manufacturing and distribution network.
(2) The food retailers and food businesses in the food service sector, which do not require to have a recall plan,
shall remove the recalled stock from shelves and return it to the manufacturer, importer or wholesaler and must
ensure that food under recall is separated and identified from other food until it is disposed of in accordance
with the instructions provided under the recall plan.
(3) The recalling food business operator(s) shall formulate a detailed recall plan as part of their food safety
management system as per the guidelines that may be framed by the food authority from time to time.
(4) At the time of actual recall being carried out, the food business operator shall submit the details of the
implementation of the food recall plan to the Chief Executive Officer, Food Safety and Standards Authority of
India and the Commissioner of Food Safety of the State or Union territory taking into account the food safety
aspects, supervise the recall, assemble data and report on the completion of recall.
(5) The food business operator(s) shall ensure effective implementation of the recall process as per the formulated
recall plan.
8. Recall communication.—(1) The food business operator initiating a food recall shall promptly inform food
business operator(s) in the food chain including consumers about the recall.
(2) Such recall communication shall be through written communication, phone, e-mail, fax, print media, electronic
media (TV or Radio or Internet or combination) or a combination thereof and in case of written communication it
shall be conspicuously marked “Food Recall”. The communication shall also be marked “urgent” and telephone
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calls or other personal communication shall be confirmed by one of the above methods and documented in an
appropriate manner.
(3) Every Food business operator in the food chain who receives a recall communication shall immediately carry out
the instructions detailed therein by the recall initiating food business operator and extend the recall to all
concerned stakeholders in accordance with sub-regulations (1) and (2) .
(4) The food business operator shall promptly inform the consumers in the affected area of the food recall through
press release, letters to the concerned parties or advertisements in the media and such press release, letter or
advertisement shall be in the form of ‘Food Recall Notice’ and shall contain the following information, namely:-
(a) Name of the Food Business Operator recalling the food;
(b) Name of the food, brand name, pack size, batch and code number, date of manufacture, used by date or
best before date;
(c) The contamination or violation in the food or reason for such recall;
(d) “do not consume message”;
(e) Health warning and action;
(f) The places or outlets where the food is found;
(g) The action to be taken by the consumer;
(h) Contact number for queries.
(5) The food business operator shall respond to queries if any from the Chief Executive Officer, Food Safety and
Standards Authority of India and Commissioner of Food Safety of the State or Union territory within twenty-
four hours of the receipt of the query. However detailed data, if required, may be submitted subsequently.
9. Recall status report.—(1) The food business operator shall determine whether the recall is progressing
effectively and shall submit periodic status reports to the Chief Executive Officer, Food Safety and Standards
Authority of India or Commissioner of Food Safety of the State or Union territory to inform them of the progress
of the recall. The frequency of such reports shall be submitted once in a week or as otherwise specified by the
Chief Executive Officer, Food Safety and Standards Authority of India or Commissioner of Food Safety of the
State or Union territory based on the relative urgency or gravity of the recall.
(2) Unless otherwise specified or not applicable in a given recall case, the recall status report shall contain the
information as specified in Schedule-II.
(3) Recall status reports are to be discontinued when the recall is terminated by the Chief Executive Officer, Food
Safety and Standards Authority of India or Commissioner of Food Safety of the State or Union territory or both,
as the case may be.
(4) The food business operator shall retain proper and complete documentation on food recall for inspection and
verification by the Chief Executive Officer, Food Safety and Standards Authority of India or Commissioner of
Food Safety of the State or Union territory or both, as the case may be.
10. Food recovery.—(1) The food business operator shall store the recovered food in an area which is separated
from any other food and is identified by a label plate including prominently that “RECALLED PRODUCT NOT
FIT FOR HUMAN CONSUMPTION”.
(2) The food business operator shall maintain accurate records of the recovered food including their lot number,
batch code, pack size, brand name, date of manufacture, date of expiry, best before date, and all related data.
Proper recording system shall be available to ensure that recalled food is retrieved and its details are recorded.
(3) The food business operator may correct or re-process the recovered food, if permitted by Chief Executive
Officer, Food Safety and Standards Authority of India. In all other cases, the food business operator shall ensure
16 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4]
disposal of such food in consultation with the Chief Executive Officer, Food Safety and Standards Authority of
India. A complete record of the disposal of such product shall be maintained.
11. Post-recall report.—(1) The food business operator shall submit a post-recall report to the Chief Executive
Officer, Food Safety and Standards Authority of India after completion of the recall process so as to enable the
assessment of adherence to the recall procedures.
(2) In addition, it is necessary for the food business operator to investigate the reasons that led to such recall and
taking action to prevent recurrence of the problem.
12. Termination of a recall.—(1) The food business operator may request termination of recall by submitting a
written request to the Chief Executive Officer, Food Safety and Standards Authority of India along with recall
status report or post-recall report certifying that the recall was effective. The request may be made in the form
specified in Schedule-III.
(2) A recall may be terminated when the Chief Executive Officer, Food Safety and Standards Authority of India
determines that it is reasonable to believe that the food under recall has been removed and/or disposed of in an
appropriate manner and that steps have been taken to ensure that such incidents do not recur and a written
communication shall be sent to the food business operator within two weeks of the request submitted by the food
business operator and food business operator can resume normal operations thereafter.
(3) In case of unsatisfactory reports, the Chief Executive Officer, Food Safety and Standards Authority of India may
consider further action like stepped-up inspection, seizure or any other legal action against the food business
operator.
13. Follow-up action.—The food business operators shall provide the Chief Executive Officer, Food Safety and
Standards Authority of India with a report as soon as a recall is completed, in any case not later than thirty days
after the completion of a recall, covering the following information, namely: -
(a) the circumstances leading to the recall;
(b) the action taken by the food business operator including details of any publicity;
(c) the extent of distribution of the relevant batch in the country and overseas;
(d) the results of the recall (quantity of stock returned, corrected, outstanding, etc.);
(e) the proposed method of disposal or otherwise of recalled stock with record of destruction and/or correction;
and
(f) the action proposed to be implemented in future to prevent a recurrence of the problem.
14. Responsibility of the food business operator.—(1) The food business operator shall have procedures and
systems in place to identify the food businesses to whom they have supplied their food.
(2) The food business operator shall collaborate with the Commissioner of Food Safety of the State or Union territory
or the Food Authority on action taken to avoid or reduce risks posed by the specific batch or lot or code of food,
which they supply or have supplied.
(3) The food business operator shall remove the food from sale or distribution, when requested by the Commissioner
of Food Safety of the State or Union territory or the Food Authority, as the case may be.
15. Responsibility of the Commissioner of Food Safety of the State or Union territory.—(1) The Commissioner
of Food Safety of the State or Union territory shall supervise the recall by the food business operator and inspect
the food business operator’s capability of recall after receiving the recall alert information and shall also be
responsible for the following, namely:-
(i) inspect the suspected or determined unsafe food after receiving complaint from the consumer, take
action as per the provisions of the Act and advise the food business operator, in consultation with the
Food Authority wherever required, to recall such food;
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(ii) to prepare and issue a media release for immediate use by the media in recalls involving consumers, and
where required, in consultation with the food business operator;
(iii) conduct audit checks when it is determined that the food business operator is unable to ensure the
effectiveness of its recall;
(iv) give instructions on the frequency of reporting the condition of recall, subject to the urgency of the case,
and to monitor the recall progress of the food business operator(s);
(v) supervise the food business operator in completion of recall and assess their recall report;
(vi) as for the foods imported into India which are recalled products in other markets or where Indian made
foods are subject to recall or rejection in country of export and returned to India, the Food Authority or
the Commissioner of Food Safety of the State or Union territory shall, in consultation with the
concerned food business operator, determine the fate of such products for disposal or reprocessing at
port or otherwise and shall review recall plan for the exported foods and advice the health authorities in
the importing countries about such recall.
(2) The Commissioner of Food Safety of the State or Union territory shall inform the Food Authority about the
execution of the above process and follow such instructions as the Food Authority may deem appropriate.
16. Responsibility of the Food Authority.—(1) The Food Authority shall guide and supervise the Commissioner of
Food Safety of the State or Union Territory in the execution of the Recall Plan and, where necessary, it may
assess the relevant reports submitted by the food business operator and give instructions as may be required.
(2) The Food Authority may establish a web based facility titled ‘Food Recall portal’ on its website with a unique
identification number assigned to each recall for monitoring and to provide information to the consumers about
such recall.
(3) The Food Authority may also publicise about the recall when it considers that the public need to be alerted about
the health hazard depending upon seriousness of the situation and it shall keep the concerned food business
operator(s) aware of the same.
Schedule – I
[See Regulation 6(3) ]
Food Recall Information
To
The CEO of the Food Authority,
The Commissioner of Food Safety of the State or Union territory _____
Sr.
No.
Subject Particulars
1. Name and Address of the food business
operator
2. Name, Designation and Contact details of
person who should be contacted
3. Identity of the implicated food (a) Name of the food
(b) Brand Name
(c) Date of Manufacturing
(d) Quantity of Food
affected
(e) Batch/Lot/Code
number
(f) FSSAI License /
Registration number
with a copy
18 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4]
Sr.
No.
Subject Particulars
4. Reason for Recall
5. Date and circumstances under which need
for food recall was discovered
6. Nature of violation of the provisions of
the Act, Rules or Regulations made
thereunder
7. Name, designation and address and
telephone number of person reporting
the problem
8. Has any testing been under taken; If yes,
results thereof
9. Total quantity food
produced/manufactured
10. Duration of food business for this product
11. Quantity of implicated product sold to the
food business operator/ individual in the
food chain with documentary proof
12. Copy of Recall Communication (if
already issued) otherwise proposed
communication and means/ proposed
means of communication
13. Action already taken and Proposed plan
for recall
14. Any other relevant information
* Please attach extra sheets, if space is insufficient
Signature and title
Date:
Schedule-II
[See Regulation 9 (2)]
FOOD RECALL STATUS REPORT FORMAT
Date: _____________
Food Authority’s Reference number for recall ___________________________
1. Name of the food
2. Name of the company
3. Brand Name:
4. Batch/Lot / Code Number:
5. Date of Mfg/ Packaging (PKD):
6. Phone:
7. Email address:
Attention CEO, FSSAI/Commissioner of Food Safety of the State or Union territory
I,________________, the authorised representative of …………..(Name of the Company) ______ hereby submit
the following Recall Status Report regarding the above-listed food:
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1. Quantity related details of the implicated product before recall initiation:
(a) Total quantity of food
manufactured:
(b) Total sold to Food Business
Operator/individual in
distribution channel:
(c) Total quantity of food to be
recalled:
(d) Details in case quantities in row
(a) and (c )are different, (reason
thereof)
2. Communication:
(a) Total number of Food Business
Operator /individual identified:
(b) Number of Food Business Operator /
individual notified:
(c) Method of notification (check all that
apply):
(i) Letter
(ii) Phone
(iii) Fax
(iv) Email
(v) Other(s): Please specify
3. Food business operator response:
(a) Total number of food business operator /
individual responding:
(b) Total number of food business operator /
individual not responding:
(c) Total quantity of food dispatched to Non-
responding food business operator/individual end:
(d) Number of packaged units and its
quantity sold to and returned by each
responding food business operator/
individual (as per traceability):
Sold Returned
Number Quantity Number Quantity
(i) Food business operator/ individual
(ii) Food business operator/ individual
(iii) Food business operator/ individual
(iv) Food business operator/ individual
(v) Food business operator/ individual
Add more, if required
Total
Quantity of implicated product accounted for (Total amount in custody of firm, including that recalled expressed
as percentage of total implicated product):
20 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4]
4. Effectiveness Checks:
(a) Total number required:
(b) Total number completed:
(c) Completion date:
5. Estimated Recall Completion Date: ____________________
6. Proposed method of disposal of recovered stock / record of destruction:
7. Actions proposed to avoid recurrence in future, if available at this point
Yours sincerely,
Signature and title
Food Business Operator
Note:
1. Provide cumulative information.
2. The final status report to be attached with the Recall termination request shall provide decided method of disposal /
records of destruction in point 6.
Schedule-III
[See Regulation 12 (1)]
FOOD RECALL TERMINATION REQUEST FORMAT
Date: ____________
To
The CEO, Food Authority ________
The Commissioner of Food Safety of the State or Union territory _________
Food Authority’s Reference No. for Recall: _________________________________
Food Business Operator Name & License No. & Registration No.: _______________________________________
Product Brand: ___________________
Food Name: __________
Date Code: ______________ Batch No. ______________ Manufacturing Date / Packaging Date __________
Best before / Expiry date ________________
Food Authority Contact: ______________________ Phone: _________________ Email: _____________
Ref: Request for Recall Termination
Attention CEO, FSSAI/Commissioner of Food Safety of the State or Union territory
I. ________________, the authorised representative of ………….(Name of the Company) state that the Company has
initiated a recall of the above-listed product/products on ____ (date)____ that extended to the ________ level. Proper
communications were made by phone, fax, email, mail and personal visits, and records of these communications have been
provided to your offices which are annexed along.
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2. All requested Status Reports have been filed (indicated if or not within the proper time-frames), and the latest
report is being submitted with this communication. _______ (Food Business Operator) _________ believes the above-
listed product has been successfully recalled.
3. In light of this executed recall, I hereby request that this food product recall be terminated.
4. The following Actions are proposed to avoid recurrence in future:
___________________
Signature
Name and designation of Authorised Signatory
Name of the company
PAWAN AGARWAL, Chief Executive Officer
[ADVT.-III/4/Exty./392/16(187O)]
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.
ALOK KUMAR
Digitally signed by ALOK
KUMAR
Date: 2017.01.24 16:03:52
+05'30'
GUIDELINES FOR FOOD RECALL
Introduction
Food on sale for human consumption must be wholesome, unadulterated,
uncontaminated, properly labelled and fit for human consumption. Violation of the
provisions in these regards may lead to regulatory action against the concerned FBO
under the Act, or rules and regulations made thereunder.
food recall
Food recalls are an appropriate method for removing or correcting marketed food
products and their labelling that violate the laws administered by the regulatory
authority. Recall can be defined as an action to remove food products from market at
any stage of the food chain, including that possessed by consumer, which may pose a
threat to the public health or food that violate the Act, or the rules or regulations
made thereunder. Recall of food product is in the common interest of the industry,
the government and in particular the consumer. Recalls afford equal consumer
protection but generally are more efficient and timely than formal administrative or
civil actions, especially when the product has been widely distributed.
Manufacturers and/or distributors should initiate a recall at any time to fulfil their
responsibility to protect the public health from products that present a risk of injury
or gross deception, or are otherwise defective. Firms may also initiate a recall
following notification of a problem by Food Authority or a state agency, in response
to a formal request by authority, or as ordered by Authority.
Purpose of this guideline
The purpose of this guide is to provide an overview of how to develop a recall plan
and how to implement that plan in the event of a recall. It will assist in identifying
products which are unsafe that violate the Act, or the rules or regulations made
thereunder and enable recall of the product(s) from the market place.
Role of the Food Authority
The Food Authority’s main role in a recall is to monitor the progress of the recall and
assess the adequacy of the action taken by the FBO in this regard. After a recall is
completed, the Food Authority will make sure that the product is destroyed or
suitably improved. Where the recall is related to serious defects in the manufacturing
process, the concerned authority may review the license of the FBO concerned.
The Food Authority will publicise the recall when it is of the opinion that the public
need to be alerted about a health hazard or that clarification of the situation needs to
be made to allay public worries.
In cases of public health emergencies, the Food Authority may, depending on the
available evidence, alert the public before a decision on recall has been reached.
Role of the industry
Food Business Operators carry the prime responsibility of implementing the recall,
and for ensuring compliance with the recall procedure at its various stages including
follow-up checks to ensure that recalls are successful and that subsequent batches of
the food products are safe for human consumption.
If a food business operator considers or has reason to believe that a food which has
processed, manufactured, distributed or imported is not in compliance with the food
safety requirements, it shall immediately initiate procedures to recall the food in
question from the market where the food has left the immediate control of that
initial food business operator and inform the competent authorities thereof. Where
the product may have reached the consumer, the operator shall effectively and
accurately inform the consumers of the reason for its recall, and if necessary, recall
food product from consumer that have already supplied to them.
A food business operator shall immediately inform the competent authorities if it
considers or has reason to believe that a food which it has placed on the market may
be unsafe for the consumers. FBO shall inform the competent authorities of the
action taken to prevent risks to the final consumer and shall not prevent or
discourage any person from cooperating, with national law and concerned
authorities, where this may prevent, reduce or eliminate a risk arising from a food.
Food business operators shall collaborate with the concerned authorities on action
taken to avoid or reduce risks posed by a food which they supply or have supplied.
Food recall plan
All food business operators as prescribed in the regulation 7 of Food Safety and
standards (Food Recall Procedure) regulations, 2017 must have an up to date recall
plan as provided in Annex (Model recall Plan)- I. At the time of recall being carried
out, the FBO shall submit their detailed recall plan to the CEO, FSSAI. A brief step by
step procedure and its description are as below.
Assemble the Recall Management Team
Notify the authority
Identify all products to be recalled
Detain and Segregate all products to be recalled which are in your firm's control
Prepare and distribute the information
of recall including Press Release
Prepare the Distribution List
Verify the effectiveness of the recall
Control the recalled product(s)
Decide what to do with the recalled product(s)
Fix the cause of the recall if the problem occurred at your facility
Conducting a recall plan
Step 1: assemble your recall management team
At the very beginning of the recall the FBO should initiate the formation of recall
management team and assign the recall duties to each person and should ensure that
all members of the recall management team are informed of the decision to conduct
a recall and each member knows their responsibilities during the recall.
The team should include people responsible for:
1. Decision making
2. Quality assurance / technical advisory
3. Media communication
4. Complaint investigation
5. Contacting accounts
6. Food Authority Contact
7. Legal Counsel
The management team document should contain the following:
RECALL MANAGEMENT TEAM
NAME ALTERNATE
PERSON
BUSINESS
PHONE
AFTER HOURS
PHONE
RESPONSIBILITIES DURING
RECALL
Step 2: Inform the authority
Inform the concerned regulatory authority at the earliest opportunity, after an incident
is identified that may lead to a recall and should be updated throughout the process.
The information should include the following:
a detailed description of the nature of the problem
the name, brand, size, lot code(s) affected
details of complaints received and any reported illnesses
the distribution of the product - local or national
when was the product distributed (specific dates)
label(s) of the product(s) which may be recalled
the total quantity of product manufactured and distributed
the name of your firm’s contact with the authority
the name and telephone number(s) for your firm’s after-hours contact
the detailed information is given under Schedule I of FSS (Recall Procedure)
Regulations, 2017
Step 3: identify all products to be recalled
It is the responsibility of FBO to ensure that all products which need to be recalled
are identified. In addition to those products directly affected by the problem, the FBO
should:
determine if any other codes, brands or sizes of the same product are affected
determine if any other products are affected
Step 4: detain and segregate products to be recalled which are in your firm's control
The FBO should ensure that all products to be recalled that are in your firm’s control
are not distributed and;
determine the locations of the recalled product(s) e.g. on-site, at the plant, off-
site storage
determine the amounts at each location
identify and segregate products to prevent distribution
Step 5: prepare and distribute the information of recall
Informing the Consumer: - Depending on the extent of the recall, the company
concerned should inform the consumer of the recall at the earliest possible moment.
Information dissemination may take the form of a press release, letter to the
concerned parties or paid advertisement in the media. Sufficient telephone hotline
service should be made available to deal with enquiries.
Information within the Food Chain: - The FBO shall inform everyone in the food
chain from the raw material vendor to the supplier and any other relevant retailer or
trade association of the affected food by written communication, phone, e-mail, fax,
or a combination of thereof.
The press release, letter or advertisement shall be in the form of ‘Food Recall Notice’
and shall contain the following information, namely: -
Name of the Food Business Operator recalling the food;
Name of the food, brand name, pack size, batch and code number, date
of manufacture, used by date or best before date;
The contamination or violation in the food or reason for such recall;
“do not consume message”;
Health warning and action;
The places or outlets where the food is found;
The action to be taken by the consumer;
Contact number for queries.
The FBO must:
complete the press release within two hours after being notified of the recall
submit a draft of the proposed Press Release, if required, to the concerned
Authority for approval
arrange for translation of the press release for concerned region
Step 6: prepare the distribution list
Keeping accurate distribution records allows to limit the recall to the specific
accounts that received the product being recalled. Using the distribution record
system, produce a product and lot code specific distribution list which:
identifies the accounts that received the recalled product
lists the accounts names and addresses, contact names
and telephone numbers
identifies the type of account e.g., manufacturer,
distributor, retailer
Step 7: verify the effectiveness of the recall
The food business operator should determine whether the recall is progressing
effectively and submit periodic status reports to the concerned authority to inform
the progress of the recall. FBO shall submit the periodic recall status report once in a
week or as otherwise specified by the concerned authority
To conduct an effective recall, the FBO should maintain the food distribution records
which include Name and address of suppliers and distributors, date of purchase of
raw material, batch code, lot number and complete traceability from Raw material to
finished good.
The FBO must;
verify that all accounts have stopped distributing and selling the
recalled product(s) product(s)
verify that the recalled product(s) have been returned to the
Step 8: control of the recalled product(s)
The product is to be recovered to a central site, or in the case of widely distributed
product, to major recovery sites. The recovered product must be stored in an area
which is separated from any other food product. Accurate records are to be kept of
the amount of recovered product and the batch codes of the product recovered.
It is the responsibility of the FBO to ensure that recalled products do not re-enter the
market.
separate and clearly identify recalled product(s)
reconcile quantities and monitor returned product(s)
record the recalled product(s) in Recalled Product
Records document
Step 9: decide what to do with the returned product
After recovery, products may be corrected or reprocessed before release to the
market if it is fit for human consumption. Otherwise the product is to be destroyed.
The action to be taken on the recalled product should be approved by the competent
Authority
decide on the action to be taken on the recalled product
e.g., correction, re-export, destruction
find out if the Authority wants to witness/verify that the
action has been taken
verify that the action has been effective
record the action taken for each product in your Recalled
Product Records document
Step 10: fix the cause of the recall
As the manufacturing firm that produced the unsafe product, it is your responsibility
for ensuring that all reasonable steps are taken to prevent similar recalls in the
future.
put controls in place or revise existing controls to
prevent similar problems in the future
protection, it is important that products which have been recalled are recorded so
that you know that the product has been controlled and has not market.
Description
Your recalled product records should contain:
a
Annexure-I
(Insert FBO Name) Recall plan
In the event that if any of our products, that presents a threat to the public health or food that
violate the Act and Rules and Regulations made there under __ (Insert name of FBO)
___will protect public health by facilitating the efficient, rapid identification and removal of
unsafe food from the distribution chain and, by informing consumers of the presence in the
market of such food.
There is a documented recall procedure in place and this will be periodically tested to ensure
that it is comprehensive and fit for purpose in its ability to remove an unsafe food from
consumers and/or the distribution chain.
Recall Procedure
Introduction
This procedure states the action/s __(Insert name of FBO)__ will take to effectively manage
the food recall in case the food does not meet the requirements of the hygiene, safety and
quality of food as well as protect the health of consumers
.
An effective product recall will ensure that the unsafe or food that violate the Act and Rules
and Regulations made there under is contained and either destroyed or rendered safe.
We will refer to and follow instructions when required which are laid out in the following
documents:
Food Safety and Standards (Food Recall Procedures) regulation, 2017
FSSAI Website (www.fssai.gov.in)
Guidelines for food recall plan
Roles and Responsibilities
It is our __(Insert name of FBO)__responsibility to effectively organise and manage the
recall of food that presents a threat to the public health or food that violate the Act and Rules
and Regulations made there under and to formulate a broad level recall plan as per FSSAI
guideline on recall plan.
The recall co-ordinator for the site is __(insert name)__who has been given authority from
management to make recall decisions on behalf of __(Insert name of FBO)__. When a recall
is initiated, our actions in recalling the affected food/s need to be co-ordinated with the
___(insert the name of concerned Authority)____
We shall notify ___(insert the name of concerned Authority)____ as soon as a recall is
likely to be initiated. It is our responsibility to manage the recall by clarifying the food safety
issue and the exposure (who and where risk exists), and to provide details on distribution and
the method of recall.
The Recall management team
The recall co-ordinator __(insert name)__ will initiate the formation of a recall management
team and will co-ordinate actions with ___(insert the name of Concerned
http://www.fssai.gov.in/
Authority)____and our marketing and distribution agents. Committee members will include
personnel from across our __(Insert name of FBO)__ Typically the committee would be like
(Insert name of FBO) RECALL PLAN
Company name: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Address: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Phone No. _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Products produced _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
RECALL MANAGEMENT TEAM
NAME ALTERNATE
PERSON
BUSINESS
PHONE
AFTER HOURS
PHONE
RESPONSIBILITIES DURING
RECALL
The recall management team is responsible for the management of all recall activities and to
adhere to this procedure. Duties of the recall management team are to:
assess the overall problem;
notify the relevant regulatory authority;
evaluate the hazard in the food and the extent of contamination;
determine a strategy to be followed;
make decisions about product still in manufacture or in storage;
notify insurers.
Recall Actions & Documentation
The recall management team shall reference and follow the actions outlined in the Safety and
Standards (Food Recall Procedures) regulation, 2017 when we become aware a product may
be unsafe or food that violate the Act and Rules and Regulations made there under. We will
ensure that records of all actions and decisions and who was responsible are recorded and
retained.
Decision to Recall
The decision to recall will be submitted to ___(insert the name of Concerned
Authority)____
Notification of a product recall
If the decision is taken to initiate a recall, we will notify:
Senior management of __ (Insert name of FBO) __, supply chain personnel
Food Authority.
Anyone that has received our product, including distributors, wholesalers,
retailers and caterers.
Consumers, via the media contacts included on our contact list.
The contact list must contain the contact details for the following:
The products recall committee and senior management and key company
personnel.
Suppliers of all ingredients.
Downstream Food Business Operator and business customers.
Sources of technical advice and support including laboratory facilities.
Regulatory Authorities.
Regaining control of affected stock
The recovered product/s will be stored in an area that is separated from any other food
products. Accurate records will be kept of the amounts recovered and the codes of the
product/s. If the recovered product/s is unfit for human consumption, it may be destroyed or
denatured under the supervision of the company management and/or the regulatory authority
where legally required.
If the food safety risk can be safely removed from the recovered product/s through relabelling
or reprocessing this may be done once it is clear that public health will be protected.
Recall Status report
Periodic status reports will be submitted to the CEO, FSSAI after the notification of the
recall for assessing the progress of the recall.
The frequency of such reports will be determined by the relative urgency/gravity of the
recall and will be specified by the concerned food authority for each recall. However, in
any case the reporting interval shall not be more than 1 week.
The recall status report should contain information specified under Schedule II of Food
Safety and Standards (Food Recall Procedure) Regulations, 2017.
Post recall report
Recall management team will submit post recall report to the CEO, FSSAI after the
completion of the recall to assess the effectiveness of the recall.
In addition, ........(insert the name of FBO) ... will investigate the reasons that led to such
recall and will take action to prevent recurrence of the problem.
Termination of a recall
........(insert the name of FBO) ... may request termination of the recall by submitting a
written request to the CEO, FSSAI along with the latest recall status report stating that
the recall was effective.
The recall will be terminated when the concerned food authority determines that all
reasonable efforts have been made in accordance with the recall strategy and it is
reasonable to assume that the food product subject to the recall has been removed and
proper disposition or correction has been made commensurate with the degree of
hazard of the recalled food product. Written notification that a recall is terminated will
be issued by the Food authority to the company.
In case of unsatisfactory reports, the concerned food authority may consider further
action like stepped-up inspection, seizure or any other legal action, against the
........(insert the name of FBO) ....
Follow up action
We…... (insert the name of FBO) ... will submit an interim report as soon as recall is
completed to the regulatory authorities within an agreed timeframe of the closure of the
recall in any case not later than thirty days after the completion of a recall. The final
report will include the elements outlined in the FSS (Food Recall Procedure)
Regulations, 2017.