PREAMBLE
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 subsection
(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
Regulation - 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.
Regulation - 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.
(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
Regulation - 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
CHAPTER-III SCOPE
Regulation - 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
Regulation - 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.
(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.
Regulation - 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.
Regulation - 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.
Regulation - 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 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.
Regulation - 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.
Regulation - 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 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.
Regulation - 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.
Regulation - 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.
Regulation - 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.
Regulation - 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.
Regulation - 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;
(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.
Regulation - 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-II
[See
Regulation 9 (2)]
FOOD
RECALL STATUS REPORT FORMAT
Date:___________________
Food Authority's
Reference number for recall__________________
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1.
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Name of the food
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2.
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Name of the company
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3.
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Brand Name:
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4.
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Batch/Lot / Code Number:
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5.
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Date of Mfg/ Packaging (PKD):
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6.
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Phone:
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7.
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Email address:
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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:
(1) Quantity related
details of the implicated product before recall initiation:
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(a)
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Total quantity of food manufactured:
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(b)
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Total sold to Food Business
Operator/individual in distribution channel:
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(c)
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Total quantity of food to be
recalled:
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(d)
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Details in case quantities in row (a)
and (c )are different, (reason thereof)
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(2) Communication:
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(a)
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Total number of Food Business
Operator /individual identified:
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(b)
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Number of Food Business Operator /
individual notified:
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(c)
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Method of notification (check all
that apply):
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(i)
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Letter
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(ii)
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Phone
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(iii)
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Fax
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(iv)
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Email
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(v)
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Other(s): Please specify
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(3) Food business
operator response:
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(a)
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Total number of food business
operator / individual responding:
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(b)
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Total number of food business
operator / individual not responding:
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(c)
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Total quantity of food dispatched to
Non-responding food business operator/individual end:
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(d)
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Number of packaged units and its
quantity sold to and returned by each responding food business operator/
individual (as per traceability):
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Sold
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Returned
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Number
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Quantity
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Number
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Quantity
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(i)
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Food business operator/ individual
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(ii)
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Food business operator/ individual
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(iii)
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Food business operator/ individual
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(iv)
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Food business operator/ individual
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(v)
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Food business operator/ individual
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Add more, if required
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Total
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(4) Effectiveness Checks:
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(a)
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Total number required:
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(b)
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Total number completed:
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(c)
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Completion date:
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(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
(1)
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.
(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