ARTICLE
23 October 2024

Understanding The Food Recall Procedure Regulations, 2017

SR
S.S. Rana & Co. Advocates

Contributor

S.S. Rana & Co. is a Full-Service Law Firm with an emphasis on IPR, having its corporate office in New Delhi and branch offices in Mumbai, Bangalore, Chennai, Chandigarh, and Kolkata. The Firm is dedicated to its vision of proactively assisting its Fortune 500 clients worldwide as well as grassroot innovators, with highest quality legal services.
Food safety is a paramount concern for consumers and regulators alike. As global trade expands and supply chains grow more complex, ensuring that the food on our plates is safe has become an essential function...
India Food, Drugs, Healthcare, Life Sciences

Food safety is a paramount concern for consumers and regulators alike. As global trade expands and supply chains grow more complex, ensuring that the food on our plates is safe has become an essential function of regulatory bodies. The Food Safety and Standards (Food Recall Procedure) Regulations, 20171 provide a structured framework for handling cases where food products may pose a risk to public health. A key feature of this framework is the food recall procedure, designed to protect consumers from unsafe food products.

One recent example2 of a precautionary recall highlights the critical role of these regulations. A well-known company, one of the world's largest exporters of Basmati rice, recently issued a voluntary recall of its popular product due to non-conformance with pesticide regulations. This recall demonstrates the necessity of having stringent guidelines and a well-defined process to manage food recalls efficiently.

Food Recalls: An Overview

Recalling food products is a measure that ensures public safety when products fail to meet regulatory standards. Recalls can happen at any stage of the supply chain, from the initial distribution to the point where products reach consumers. Whether initiated voluntarily by food business operators (FBOs) or directed by authorities, recalls prevent unsafe products from harming public health.

The Food Safety and Standards Act, 2006, lays down the legal foundation for regulating food safety in India. Under this Act, FBOs are responsible for ensuring the safety of their products. However, despite stringent regulations, situations may arise where products need to be withdrawn from the market. This is where the 2017 regulations come into play.

Key Provisions of the Food Recall Procedure Regulations, 2017

  1. Initiation of the Recall Process
    The Food Safety and Standards (Food Recall Procedure) Regulations, 2017 require FBOs to initiate a food recall in response to food safety risks. The FBO must ensure that the process complies with Section 28 of the Food Safety and Standards Act, 2006. This section mandates the recall of unsafe food products and imposes obligations on FBOs to notify authorities and consumers about the recall.

    The recall can be initiated either by the FBO itself or at the direction of the Chief Executive Officer (CEO) of the Food Safety and Standards Authority of India (FSSAI), or the Commissioner of Food Safety of a state or Union territory. In the event that an FBO fails to act, regulatory authorities have the power to intervene and mandate the recall.
  2. Responsibilities of Food Business Operators
    All FBOs in the food chain, from manufacturers to retailers, must implement the recall process. Failure to comply with recall instructions can result in severe penalties, including fines, legal action, or even imprisonment, as provided under the Food Safety and Standards Act. Moreover, the regulations obligate FBOs to maintain comprehensive distribution records, which must include details such as supplier and customer information, batch numbers, and expiration dates.
  3. Post-Recall Actions
    After initiating a recall, FBOs are required to submit a post-recall report and carry out follow-up actions. This ensures that the recall has been effective and that the affected product is no longer in circulation. The regulations also emphasize preventing future occurrences, with FBOs required to take corrective measures to avoid similar issues in the future.
  4. Recall Plan
    Under the regulations, FBOs engaged in manufacturing, importing, or wholesaling food must have a detailed recall plan as part of their food safety management system. The recall plan must outline the steps to be taken in case of a recall, including communication protocols, identification of affected batches, and methods for removing the product from the market.

    Interestingly, while retailers are not required to have a recall plan, the regulations make an exception for those involved in manufacturing, importing, or wholesaling food products. Additionally, food service establishments like restaurants are generally exempt unless they operate a multi-outlet chain with an integrated manufacturing and distribution network.
  5. Recall Communication
    Communication is crucial during a food recall. The regulations require FBOs to inform everyone involved in the food chain, including consumers, suppliers, and regulatory authorities. This communication can be conducted through various channels, such as written notices, emails, phone calls, and media announcements. The information disseminated must include key details such as the name of the recalled product, the contamination or violation, and instructions on what consumers should do.
  6. Food Recovery
    In cases of food recovery, FBOs are responsible for managing recalled products according to strict guidelines:
    • Recovered food must be stored in a designated area, separate from other food products, and clearly marked with a label stating, "RECALLED PRODUCT NOT FIT FOR HUMAN CONSUMPTION."
    • FBOs must maintain detailed records of the recovered food, including lot numbers, batch codes, pack sizes, brand names, dates of manufacture and expiry, and all relevant data. The system must ensure proper tracking and recording of the recalled products.
    • In certain situations, FBOs may correct or reprocess the recovered food, provided they receive permission from the FSSAI's Chief Executive Officer. If correction or reprocessing is not feasible, the FBO must ensure the proper disposal of the food in consultation with the FSSAI. A comprehensive record of the disposal process must be maintained.
  7. Consumer Protection and Public Health
    At the heart of the Food Recall Procedure Regulations is consumer protection. The recall process must prioritize public health and safety. For instance, the FBO must stop the distribution and production of the recalled product immediately upon becoming aware of the issue, even before receiving formal instructions from regulatory authorities.

    The regulations also mandate that consumers be promptly informed through press releases, advertisements, or direct communication. The communication must include critical details, such as a "Do Not Consume" message, health warnings, and steps consumers should take if they have purchased the recalled product.

Penalties for Non-Compliance

Failure to comply with the recall procedures can result in significant penalties for FBOs. The FSSAI and the Commissioner of Food Safety have the authority to take regulatory action if an FBO refuses to initiate a recall or if the recall is ineffective. These actions can range from monetary penalties to more severe consequences like suspension or cancellation of licenses.

Moreover, the recall of imported food products is not exempt from these regulations. Imported goods may also be subject to recalls based on reports from foreign health and food authorities.

Conclusion

The Food Safety and Standards (Food Recall Procedure) Regulations, 2017, play a critical role in ensuring that unsafe food products are swiftly removed from the market. As demonstrated by the recent precautionary recall of a popular Basmati rice product, the regulations provide a comprehensive framework for protecting consumers and maintaining trust in the food supply chain. For FBOs, compliance with these regulations is not only a legal obligation but also an ethical responsibility. By implementing a robust recall plan and adhering to the guidelines set forth by the FSSAI, FBOs can minimize the risks associated with unsafe food products and safeguard public health.

As the food industry grows and evolves, staying compliant with food safety regulations is more important than ever. With the ever-watchful eye of regulatory authorities and increasing consumer awareness, FBOs must remain proactive in ensuring that their products meet safety standards. A well-executed food recall can mitigate risks and preserve a brand's reputation, making it a vital component of any food business's risk management strategy.

Footnotes

1 F. No. 1-59/FSSAI/2009- Food Safety and Standards (Food Recall Procedure) Regulations, 2017

2 Available at https://www.zeebiz.com/companies/news-india-gate-basmati-rice-maker-recalls-packets-over-pesticide-concerns-shares-fall-over-15-318327

For further information please contact at S.S Rana & Co. email: info@ssrana.in or call at (+91- 11 4012 3000). Our website can be accessed at www.ssrana.in

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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