FSSAI issues Gazette Notification on Food Recall Procedure

\In April 2015 the FSSAI had first proposed a draft regulation on Food Recall Procedure. The draft regulation was made available to the public for their comments suggestions and objections. After taking into consideration the suggestions of stakeholders the FSSAI has issued the final notification for food recall procedure regulation on 18 January 2017 and will be known as Food Safety and Standards (Food Recall Procedure) Regulation -2017.  Chapter I of these regulations defines the various terms related to food recall like food chain, food recall plan, food under recall, traceability, recall alert, unsafe food etc. Chapter II outlines the objective which is to ensure

• removal of food under recall from all stages of the food chain in accordance with Section 28 of the Act
• dissemination of information to concerned consumers and customers
• retrieval, destruction or reprocessing of food under recall

Chapter III outlines the scope of the food recall procedure. It states that these recall procedures will apply to food or food products that are

• determined or are prima facie considered unsafe
• and also as may be specified by the Food Authority from time to time

Foods not to be considered unsafe Any food articles that 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 outlines the recall procedure If a recall is required then Food Business Operators (FBOs) will fulfil their responsibility in accordance with Section 28 of the Act. 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 carry out the recall process which has been initiated as a result of complaints and reports. FBO must follow the full procedure and complete process of recall so that it is fully effective. In case the FBO does not respond to the recall consumers may inform  CEO FSSAI or Commissioner of Food Safety of the State or Union territory or both who will then take steps to determine the need for recall and instruct the concerned FBO regarding the recall and the FBO will be bound by such instructions. If anyone along the food chain fails to do so they too could be liable to action under the Act, rules and regulations. Similarly a recall of imported food can also be initiated on the basis of reports of health or food authorities. The Chief Executive Officer, Food Safety and Standards Authority of India or Commissioner of Food Safety of the State or Union territory can take appropriate action under the Act, rules and regulations if they have reason to believe that

• additional measures would be required to make the recall ineffective
• unsafe food is continuing to be manufactured by the FBO
• the FBO will be liable for such action 

Operation of Food Recall System The food business operator shall maintain the food distribution records for a period of one year from best before or expiry date. It will include

• 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
• for alcoholic beverages records for a period of two years from date or month of supply from the manufacturer

FBO must report to the Authority through fax, e-mail and speed post immediately but not exceeding twenty-four hours from the time it comes to his notice that such food requires recall. Before instructions come from the Food Authority the FBO must

• stop the distribution of food under recall
• 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, relevant retailers or trade associations and immediately identify all required product details along with any additional details which would facilitate speedy identification and recall 

Food Recall plan 

• All food business operators engaged in the manufacture or import or wholesale supply of food regulated under the Act must have an up-to-date recall plan.
• Food retailers are not required to have a food recall plan.
• 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.
• Food retailers and food service sector businesses, however, need to remove the recalled stock from shelves and return it to the manufacturer, importer or wholesaler and keep it identified and separate.
• Recall plan must be part of their Food Safety Management System (FSMS) and submit details at the time of food recall, supervise the recall, assemble data and report on the completion of recall and ensure effective implementation.

 Recall Communication (Format in Schedule II) Any FBO recalling food must immediately inform consumers through written communication, phone, e-mail, print media, press release, TV, radio, internet or a combination of these. It must be in the format provided by FSSAI as ‘FOOD RECALL NOTICE.’ It must have

• 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
• Health warning and action along with “do not consume message”
• The places or outlets where the food is found
• The action to be taken by the consumer
• Contact number for queries

Recall status report (Schedule II) FBO must periodically submit the recall status reports to the Food Authority to determine the effectiveness of the report according to the format given in Schedule II of these regulations. All documentations on food recall need to be maintained for inspection and verification. Food recovery requirements  

• FBO must 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”
• The food may be corrected or re-processed if permitted by the CEO FSSAI or disposed appropriately.
• Accurate record must be maintained of the recovered food including lot number, batch code, pack size, brand name, date of manufacture and expiry date, best before date in a proper recording system.

A post recall report must also be filed with the CEO FSSAI to assess the adherence of the recall and to take action to prevent recurrence. FBOs can request for a termination of recall by submitting a written report to CEO FSSAI along with recall status report and post recall report. The CEO can terminate the recall it is determined that the recall has been carried out appropriately and there is no recurrence. Schedule III contains the food recall termination request format. Follow up action The food business operators shall provide the CEO FSSAI a report as soon as a recall is completed or not later than thirty days after the completion of a recall. It should cover

• circumstances leading to the recall
• action taken by FBO including details of any publicity
• extent of distribution of the relevant batch in the country and overseas
• results of the recall (quantity of stock returned, corrected, outstanding, etc.)
• proposed method of disposal or correction of recalled stock with record of destruction and/or correction
• proposed action to be implemented in future to prevent a recurrence of the problem.

The regulation also outlines the responsibility of the

• FBO
• Commissioner of Food Safety of the State or Union territory
• Food Authority

Food recall Information is to be provided as per table below (schedule I) and addressed to: The CEO of the Food Authority, The Commissioner of Food Safety of the State or Union territory……..

Sr. No

                         Subject

              Particulars

Name and Address of the food business operator

Name, Designation and Contact details of person who should be contacted

Identity of the implicated food

a)

Name of the food

b)

Brand name

c)

Date of manufacturing

d)

Quantity of affected food

e)

Batch/lot/code number

f)

FSSAI license/registration number

Reason of recall

Date and circumstances under which need for food recall was discovered

Nature of violation of the provisions of the Act, Rules or Regulations made thereunder

Name, designation and address and telephone number of person reporting the problem

Has any testing been under taken; If yes, results thereof

Total quantity food produced/manufactured

Duration of food business for this product

Quantity of implicated product sold to the food business operator/ individual in the food chain with documentary proof

Copy of Recall Communication (if already issued) otherwise proposed communication and means/ proposed means of communication

Action already taken and Proposed plan for recall

Any other relevant information

Signature and title