The FSSAI has issued Food Recall Guidelines in addition to the Food Safety and Standards (Food Recall Procedure) Regulation, 2017.
Food on sale for human consumption must be wholesome, unadulterated, uncontaminated and properly labeled. Any violation of these provisions can lead to regulatory action against the concerned FBO under the Act, or Rules and Regulations made thereunder.
The food recall is a procedure used for removing or correcting marketed food products and their labeling if they violate any food law of the Regulatory Authority of the FSSAI. A recall is defined as the action taken to remove food products from the market at any stage in the food chain if it poses a threat to the health of consumers or violates any food laws. Food that is in the possession of the consumers may also be removed. The food recall is exercised in the interest of the industry, the government and most particularly the consumer. Food recalls are more efficient than administrative action if foods have been widely distributed.
- Manufacturers and/or distributors should voluntarily initiate a recall as part of their responsibility to protect 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 Guideline
- This guideline has been outlined with the purpose of helping FBOs develop a recall plan that will help them implement the plan if a recall is required.
- It will assist in identifying products that are unsafe or that violate the Act, or the rules or regulations made thereunder and enable recall of the product(s) from the marketplace.
Role of the Food Authority in a Recall
- monitor the progress of the recall
- assess the adequacy of the action taken by the FBO in this regard
- After recall, the Food Authority will ensure proper destruction of products of suitable improvement the
- In case of manufacturing defect, the concerned authority may review the license of the FBO concerned
- publicise the recall if the public needs to be alerted about a health hazard or to clarify the situation to allay public worries
- alert the public about impending recall in case of public health emergencies and depending on the available evidence
Role of the industry
Food Business Operators carry the prime responsibility of
- implementing the recall
- ensuring compliance with the recall procedure at various stages
- follow-up checks to ensure that recalls are successful
- ensure subsequent batches of the food products are safe for human consumption
- If an FBO considers or has reason to believe that a processed, manufactured, distributed or imported food 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 the initial FBO and inform the competent authorities thereof.
- Where the product has reached the consumer, the FBO shall effectively and accurately inform the consumers of the reason for its recall, and if necessary, recall food product from the consumer if it is in their possession
- FB 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.
- FBOs 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
As prescribed regulation 7 of Food Safety and Standards (Food Recall Procedure) Regulations, 2017 all FBOs 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 the 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 a distribution list
- Verify Effectiveness of recall
- Control recalled products
- Decide what to do with recalled products
- Fix the cause of the recall if it occurred at your facility
Step 1 Assemble recall team and inform them of the recall decision and assign recall duties. Outline the responsibilities as follows
- Decision making
- Quality assurance / technical advisory
- Media communication
- Complaint investigation
- Contacting accounts
- Food Authority Contact
- Legal Counsel
Prepare a document with the name, business phone number, after hours, alternative person and responsibilities of each team member.
Step 2 Inform Authorities
Inform the regulatory authorities at the earliest opportunity and keep them updated throughout the recall process. Give the following information
- 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 products to be recalled
All products that need to be recalled must be identified and also determine if
- whether other codes, brands or sizes of the same product are affected
- if any other products are affected
Step 4 identify, detain and segregate products to be recalled which are in your firm’s control and are not re-distributed so determine the
- location of the recalled product(s) e.g. on-site, at the plant, offsite storage
- the amount in each location
Step 5 prepare and distribute the information of recall
- Inform the consumer through
- press release
- letter concerned parties
- a paid advertisement in the media
- sufficient telephone hotline service should be made available to deal with inquiries
- Information within the food chain must be given through written communication, phone, fax, e-mail or in combination to
- Raw material vendor
- Retailer or trade association
The press release, letter or advertisement shall be in the form of ‘Food Recall Notice’ and shall contain the following information
- 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 a 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
- A 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
Accurate distribution records will allow you to identify who received the product and so prepare 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, the retailer
Step 7 Verify the effectiveness of the recall
FBO must determine whether the recall is progressing effectively and submit periodic status reports (like once a week or as determined by concerned authority) to the concerned authority to inform the progress of the recall.
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 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.
Step 8 control of the recalled product(s)
The recovered product must be
- directed to a central site, or in the case of widely distributed product, to major recovery sites
- stored in an area which is separated from any other food product
- Accurate records must 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 releasing 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 the responsibility of FBO to
- ensure 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
Annexure 1 contains the detailed outlines the detailed communication and forms that can be utilized for various recall procedures
(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 thereunder __ (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.
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 violates the Act and Rules and Regulations made thereunder 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 organize 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 thereunder and to formulate a broad level recall plan as per FSSAI guideline on recall plan.
The recall coordinator 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 coordinated 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 coordinate actions with ___ (insert the name of Concerned 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|
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 the 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 violates the Act and Rules and Regulations made thereunder.
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 relabeling 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 a the 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.