based on draft regulation proposed by FSSAI for recall management

1. Guidelines on Food Recall
Quality Control and Assurance

2. What is Food Recall
It is process of removing food products from market at any stage of the food chain, including that possessed
by consumer, which may pose threat to public health or food that violate the act or the rules or the
regulations

3. Why to recall food?
Any of the below mentioned situation can create recall situation:
 In case product is not wholesome or adulterated or contaminated
 In case product is not properly labeled
 In case of violation of rules and regulations

4. Instances of Recall
Case 1: BARRY Callebaut USA is recalling its Kroger brand Semi Sweet Chocolate Chips as they may contain undeclared allergen, milk protein.
Case 2: Kraft recalls chocolate on fears of salmonella By Mike Hughlett Tribune staff reporter October 5, 2007 Kraft Foods Inc. has recalled
288,000 packages of white chocolate baking squares on fears of salmonella contamination, the latest in a wave of U.S. food safety alerts and the third
chocolate-related salmonella warning in the past year. The Northfield-based food giant issued the recall late Wednesday for certain six-ounce packages
of Baker's Premium White Chocolate Baking Squares. The recall came after the U.S. Food and Drug Administration detected salmonella in some
packages of Baker's Premium, Kraft said. Salmonella is a bacterium that can cause fever, diarrhea, and abdominal cramps, and can create life
threatening infections in people with weakened immune systems.
Source: http://www.chicagotribune.com/business/chi-fri_kraft1005oct05,0,2726091.story

5. Highlights

6. Role and Responsibility
Role of the Food authority
 To monitor the progress and effectiveness of recall process carried out by FBO.
 To make sure recalled product is destroyed or suitably improved.
 Can review license of FBO in case of serious defect in the manufacturing
To provide termination of recall in case of effective process.
Role of the FBO
To take decision regarding recall.
 To create recall management team
To inform regulatory authority in case food product may pose threat to consumer
To inform all in food chain from raw material supplier to end consumer
To carry out recall process as per guidelines.
To prepare and submit recall effectiveness report to CEO, FSSAI

7. Food Recall Process [ based on FSS (Food
Recall Procedure) regulations, 2017]
Assemble recall management team
Notify the authority
Identify all products to
be recalled
Detain and segregate all products to be recalled which are in firm's control
Prepare and distribute recall notice. press release
Prepare distribution list
Verify recall
effectiveness
Control recalled products
Decision on recalled products
Fix cause of recall if problem occurred within facility. CAPA
Termination of Recall

8. Step 1: Assembling of Recall Management
Team
Recall
coordinator
Top
management
HRA
Regulatory
officer
Quality
Control and
Assurance
Sales
Supply chain
managers [
purchase
and
logistics]

9. Duties of Recall Management Team
 Assess overall problem
Notify relevant regulatory authority
 Evaluate the hazard in the food and extent of contamination
 Determine strategy to be followed
Make communication with those involved in food chain right from raw material supplier to end
consumer.
 Prepare recall distribution record.
 monitor effectiveness of recall and prepare recall effectiveness report.
Take decision on recall product.
Carry out root cause analysis to fix problem and avoid reoccurrence

10. Step 2: Inform the authority
Following information regarding recall must be provided to concerned regulatory authority:
• Detail of product: Name, MFD, Best before date, Batch code, quantity
• Nature of problem e.g., product defect, label issue etc.
• Distribution detail: Date of distribution, location wise quantity
• Label of affected product
•Quantity under manufacturer control
• Name and contact detail [ business and after hours]of company contact

11. Step 3: Identification of product to be
recalled
 Identification of product to be recalled- name, manufacturing date, batch, quantity produced
To determine whether any other batch or product exhibit same problem

12. Step 4: Segregation of products to be
recalled which are in firm control
 Assess quantity which are still under manufacturer control
 Assess storage location
 Assess location wise quantity
 control of segregated lot to prevent mix up with normal lot

13. Step 5: Prepare and distribute recall notice
Information to consumers-
 Through press release [in state’s local language] within 2 hours after recall decision.
 Submission of draft copy of recall to regulatory authority, if required.
 Hotline numbers must be made available for enquiries
Information within food chain: by written communication, phone, email, fax or combination
Content of Recall notice
• Name of FBO carrying out recall
• Product detail
• Reason of recall
• Health warning and action
• Do not consume message
• Distribution detail
• Action to be taken by consumer
• Contact detail for query

14. Step 6: Prepare distribution list
Prepared by FBO for effective management of recall process
 Identify accounts
Identify type of account: distributor, retailer etc
Prepare list of account: Name, address and contact detail
Assess quantity at each location

15. Step 7: Verify effectiveness of recall
FBO shall verify effectiveness of recall process
Must ensure that all accounts have stopped distribution and sale of recalled batch.
 Ensure affected lot returned to central location or major recovery site in case of widely
distributed product.
Prepare and submit recall effectiveness report to regulatory authority on weekly basis or as
specified.

16. Step 8: Control of recalled product
Must be kept separate with proper tagging.
Regular monitoring
Record keeping

17. Step 9: Decision on recalled product
Decide on action to be taken on recalled product e.g., correction, destruction
Find out if authority want to witness on verify the action taken
Record keeping

18. Step 10: Fix cause of recall
Put controls to prevent reoccurrence of similar problem in future

19. Termination of Recall
 FBO shall submit recall termination request along with recall effectiveness report to CEO, FSSAI
 CEO, FSSAI will verify the effectiveness of recall.
 If found effective- written notification for recall termination will be issued by Food authority to
company.
If not found effective- orders for further inspection, seizure or any other legal action against
FBO