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) Regulation, 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.
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
Assemble the Recall Management Team
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) Regulation,
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
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
(The CEO, FSSAI [in case of Central License] or The Commissioner of Food Safety of
the State/UT [in case of State License]).
We shall notify (The CEO, FSSAI [in case of Central License] or The Commissioner of
Food Safety of the State/UT [in case of State License]) 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 (The CEO, FSSAI [in case of Central
Annexure-I
(Insert
FBO
Name)
License] or The Commissioner of Food Safety of the State/UT [in case of State License])
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 Food
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 (The CEO, FSSAI [in case of Central License]
or The Commissioner of Food Safety of the State/UT [in case of State License])
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) Regulation, 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) Regulation, 2017.
