FSSAI has proposed a draft regulation which explains the procedure to be followed in case there is a need to recall food. Objections and suggestions have been invited till up to 60 days after notification in the Official Gazette which FSSAI could take into considerations if these are provided within the specified time. Once approved and published in the Official Gazette then these regulations would be called Food Safety and Standards (Food Recall Procedure) Regulations, 2015.
“Recall” means and refers to action taken to remove ‘unsafe food’ under recall from distribution, sale and consumption as appropriate. Unsafe food is defined under Section 3 (1) (zz) of the Act.
In order to carry out recall procedure it is important to first understand certain definitions that will be used in the FSSAI proposed regulations.
“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/UT or the Food Business Operator, as unsafe food causing injury or liable to cause injury to health or even death.
“Public warning” means any alert issued to the public by the Food Authority; or the Commissioner of Food Safety of the State/UT or the Food Business Operator with the approval of the Food Authority that the food being recalled is unsafe and injurious to health.
“Recalling food business operator” is the manufacturer, importer or company engaged in wholesale supply and/ or distribution or the brand owner, who has the primary responsibility to recall unsafe food.
“Recall plan” means a written set of procedures, practices and actions to be put in place by the food business operator for food recall.
The Objectives of the Food Recall Procedure
- The main objective of the food recall procedure is to offer guidelines to FBOs so that they can carry out food recall process using global identification systems like barcode and other instruments like email, paper, fax etc.as these are communications that facilitate fast removal of the food under recall from the distribution chain and also inform consumers, when necessary, about the presence of such food in the market and ensure that unsafe food is contained and destroyed or rendered safe.
- FBOs will establish a written ‘Recall Plan’ for executing the food recall process in case any food is determined to be unsafe so that the heath of consumers is protected at all times.
- Once the regulations come into force complete guidelines will be available for;
i) recall process
ii) post-recall report
iii)closure of the recall process and follow-up action
These are important proceedings that will ensure that the recall has been effective and will help to prevent a recurrence.
It is for this reason that all food business operators who manufacture or import food or wholesale suppliers of food are required to have an up – to – date recall plan.
- A recall plan must be in writing and must be made available to Food Authority or the Commissioner of Food Safety of the State/UT on request.
- All FBOs will have to comply with the recall plan that has been developed when it recalls food and the recall plan shall be integrated into the business.
- Recall plan will be part of the annual audit of the food business.
Some FBOs are exempted from recall plan and these are
- food service sector such as restaurants,
- caterers and
- takeaway joints
- food retailers
However, these outlets must not be running multi-outlet food business chains with integrated manufacturing and distribution network. In case a recall is ordered by any FBO who is a manufacturer, importer or wholesaler, then these food service FBOs have to also remove stock from shelves and return it to the manufacturer, importer or wholesaler. They need to 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.
In the case of alcoholic beverages, pan masala, supari, the mandatory mention of warning “consumption of alcohol/ pan masala/ supari is injurious to health” may not be treated as unsafe food as part of any recall plan unless the beverage or food is determined unsafe as per the classification of recall making it injurious to health or even causing death.
Food Recall Procedure
A recall process will only be initiated if there are any reports or complaints from multiple sources with reference to a particular FBO. The reports or complaints may be from manufacturers, wholesalers, importer, exporter, distributor, retailers, consumers, media, government agencies and Food Authority or the Commissioner of Food Safety of the State/UT. However before recall, these reports or complaints shall be reviewed by the Food Authority in consultation with the FBO in accordance with the guidelines. If any FBO does not respond to the complaint, the complainant or the consumer may report the matter to the Commissioner of Food Safety of the State/UT or the Food Authority who will take steps to determine the need for recall and instruct the concerned FBO accordingly to initiate the recall.
All other FBOs in the entire distribution chain will be required to implement the instructions that come from the recalling food business operator and will be required to conduct the recall and provide information on the distribution of the food to the recalling food business operator or the Commissioner of Food Safety of the State/UT or the Food Authority. Any failure on the part of the part of any FBO to implement the recall procedure once ordered will be liable to action as per the Act. The State Food Authority or Food Authority can also take appropriate action if it finds that a recall is not effective or if it finds that the violation is continuing.
Any recall of food that is manufactured overseas may also be initiated on reports of health authorities, or from information received directly from such authorities or others. Export units will also need to have a recall plan especially if the food products are directed to local consumers in India. Additionally, food imported into country will be checked by port authority and concerned food safety officer to ensure that the food has not been rejected or recalled any market, so that it is not disbursed in local market as unsafe food.
Operation of Food Recall System
An FBO must maintain
- food distribution records which include the names and addresses of suppliers and customers
- the nature of food and date of purchasing and delivery, lot No. or batch code, pack size, brand name, date of manufacture and best before date, and
- all records will need to be maintained for a period of one year or the expiry of shelf life of food, whichever is later.
The recalling FBO needs to
- Submit a recall alert notification as specified to the State Food Authority or Food Authority immediately and within 24 hours from the time it comes into notification that food is unsafe and recall exercise shall be immediately initiated.
- To ensure speedy communication, such alert(s) may be sent by using all possible means of communication including fax, e-mail, or by speed post.
- The State Food Authority shall inform of such recall alerts to Food Authority within twenty four hours of receipt of such information.
- The recalling food business operator shall stop production of food under recall and/or stop distribution, without waiting for any instructions from the Food Authority or the Commissioner of Food Safety of the State/UT so as to ensure that consumer safety is not compromised.
- All distributors of the affected food need to be contacted by written communication, phone, e-mail, fax, or a combination of all and all suppliers need to be notified so the food is immediately identified, so recovery can be quick.
- The recalling food business operator may resume distribution of the identified food under recall after obtaining clearance from the State Food Authority or Food Authority, as the case may be.
- The food business operator shall conduct the recall in accordance with the recall plan submitted to the State Food Authority or Food Authority without waiting for the response of the State Food Authority or Food Authority. However, the suggestions received from any of these Authorities at any stage, shall be duly taken into account while executing the recall plan.
- The recalling FBO has to provide a recall status report to the Commissioner of Food Safety of the State/UT or the Food Authority about the progress of the recall and its effectiveness. These status reports can be terminated only on the nod from State Food Authority or the Food Authority
- All recovered food needs to be stored in an area which is separated from any other food and is identified by a label plate with prominently written “RECALLED PRODUCT”.
- Accurate reports are to be maintained of the recovered food and their lot No. or batch code, pack size, brand name, date of manufacture, best before date, unique product code number (EAN or UPC code), etc. Proper recording system shall be available to ensure that recalled food is retrieved and its details are recorded.
- The food may be reprocessed if appropriate and safe or completely destroyed in consultation with the State Food Authority or its representative. A complete record of the disposal of such product shall be maintained.
- A post recall report needs to be submitted by the FBO which states the completion of the recall process and the effectiveness of the recall, with a follow up investigation so the problem does not recur.
A food recall can be terminated after the Commissioner of Food Safety of the State/UT or the Food Authority receive a termination application from the FBO and determine that the food under recall has been removed and proper disposition or correction has been made in the processing of the food.