The Food Safety and Standards Act, 2006 (“Act”) was enacted in India for standardising, protecting and promoting public health through the regulation and supervision of food and the ways and means by which food is marketed and advertised. In the past few years, significant developments have taken place in the regulatory framework, particularly with regard to the enforcement of the provisions of the Food Safety framework and this piece, amongst other things, will focus on providing an insight into the manner in which the Food Safety Authorities test samples of food and the remedies available against an unexpected outcome of such testing under the legislative framework.
Liability of Food Business Operators
The Act provides a comprehensive definition of Food Business and Food Business Operator1 (“FBO”), which includes manufacturers, packers, wholesalers, distributors and sellers of food. Furthermore, the Act provides that an FBO has to ensure compliance with the food safety provisions under the Food Safety framework and provides that an FBO shall be held liable in case of contravention of the provisions under the Food Safety framework2 which includes but is not limited to the FBO's liability to ensure that expired food products are not sold, food(s) are stored properly and food safety is maintained, items are not unsafe or misbranded, and are properly labelled. Any violation of the provisions of the Act can lead to fines and also imprisonment, apart from causing serious reputational risks from the FBO's perspective, which takes painstaking and consistent efforts for years together (if not decades) to build.
Enforcement of the provisions
As a means to enforce such food safety and standards, the Food Safety Officer3 (“FSO”) is empowered to take a sample of any food, or any substance, which appears to him to be intended for sale or to have been sold for human consumption4. This power can be exercised at the discretion of the FSO.
Given the fact that most food items involve complicated supply chains, processing at various stages, industrial processes, and are essentially mixtures of various items and involve a high level of biochemistry, there are chances that one batch or for that matter, one localized sample might differ from another and may lead to adverse findings given the myriad of variables involved. Such adverse findings can lead to a cascading effect in terms of loss of goodwill and reputation in the market and exposure to prosecution.
Fortunately, the food safety and standards framework, being a self-contained code in itself, provides a relatively comprehensive mechanism for the collection of samples, testing and appeals to ensure that the tests carried out are not erroneous and that the principles of natural justice are followed. This enables appropriate checks and balances in respect of the draconian powers otherwise available to the authorities under the Act considering that the stakes are high as it concerns human health, safety and hygiene.
When an FSO collects a sample of food, they must adhere to the prescribed mechanisms5. While collecting the sample, the FSO shall inter alia ensure that sufficient amounts of a sample have to be collected in a manner so as to ensure that the sample is not tainted. The FBO from whom the food sample is collected, the manufacturer, the marketing company, etc. are notified of the sample collection (vide Form V-A6). Further, the sample is collected in front of a witness and the witness, as well as the FBO's signatures are obtained on various documents prepared at the time of sampling.
At the time of collecting the food sample, the FSO is required to divide the sample into four parts to send one sample for testing to the Food Analyst at a Food Safety and Standards Authority of India(“FSSAI”) notified laboratory for testing and the remaining three samples to the Designated Officer.
Recourse available to FBOs
As per Rule 2.4.5 of the Food Safety and Standards Rules, 2011 (“Rules”), the FBO has the right to send one part of the 3 remaining samples collected by FSO to a National Accreditation Board for Testing and Calibration (“NABL”) accredited/FSSAI Notified laboratory of its choice. However, it is relevant to note that this right has to be exercised and its application is not automatic. This provision when exercised properly, provides a FBO with an added layer of redundancy with respect to test results and ensures that errors in testing, if any, are highlighted.
Once the sample has been received by the Food Analyst, they have the power to analyse the food sample and prepare a report within 14 days of receiving such sample7. Based on the report of the Food Analyst, the Designated Officer has the power to make recommendations to the Commissioner of Food Safety for sanction to launch prosecution in case of any contravention punishable under the Act.
However, the food safety and standards framework provides a mechanism for appeal against the report of the Food Analyst under Section 46(4) of the Act read with Rule 2.4.6 of the Rules.
The Act provides:
“An appeal against the report of Food Analyst shall lie before the Designated Officer who shall, if he so decides, refer the matter to the referral food laboratory as notified by the Food Authority for opinion.”
The Rules provide:
“Appeal to the Designated Officer: 1. When an appeal as provided under subsection 4 of section 46 is preferred to the Designated Officer by the Food Business Operator against the report of the Food Analyst, the Designated Officer, shall if he so decides, within thirty days from the receipt of such appeal after considering the material placed before him and after giving an opportunity to Food Business Operator to be heard shall forward one part of the sample to the referral lab. Such appeal shall be in Form VIII which shall be filed within 30 days from the date of the receipt of the copy of the analysis report from the Designated Officer. Report of the referral laboratory shall be final in this regard.
- The Designated Officer shall forward one part of the sample under appropriate condition as specified for the product including transport, to retain the integrity of the sample. The cost of analysis of the sample shall be borne by the Food Business Operator. The remaining samples will also be safely kept under appropriate conditions to prevent deterioration.”
As can be seen, the above provisions provide an opportunity to the FBO to place on record its case and have the 3rd (third) part of the sample tested at a “Referral Laboratory”. This provision contemplates that in case the Designated Officer exercises his discretion to send the 3rd part of the sample to a “Referral Lab”, he is required to provide the FBO with an opportunity of hearing and must consider the materials placed on record and subsequently pass a reasoned order. The Courts have time and again held that such discretion by the Designated Officer cannot be exercised arbitrarily or capriciously and reasons for refusal, if any, have to be provided and an appeal under Form VIII cannot be dismissed in limine8.
In our experience, however, the Designated Officers usually decide appeals in a perfunctory manner and the opportunity of hearing given to the FBO is merely an eye-wash as a precursor to initiating prosecution. In view of such an approach, it is advisable for the FBO to be vigilant so that any action on the part of the Designated Officer to undermine the rights are dealt with appropriately and/or challenged before the appropriate court/ forum.
At this juncture, it becomes relevant to understand what a Referral Lab is. Referral Laboratory is defined under Rule 1.2.1(10) as “any of the laboratories established and/or recognized by the Food Authority by notification under sub section (2) of section 43 of the Act.”
The Food Safety and Standards (Laboratory and Sample Analysis) Regulations, 2011 shed further light on Referral Laboratories. At the time of the introduction of the Regulation, there were only a handful of Referral Labs. However, such labs would be linked to specific States wherein any successful appeal under Form VIII made in a particular State would be tested only at the specific Referral Laboratory that was prescribed, thereby restricting the choice of an FBO and monopolising the already dominant position of the authorities under the Act.
However, on 15 October 2020, the Regulation was amended and the nexus between States and specific referral laboratories was removed and the Regulation now only provides that the laboratories notified under Section 43(2) of the Act will be relevant for the definition of Referral Labs.
In case the Appeal under Form VIII is not filed or the sample fails at the Referral Laboratory, the Commissioner of Food Safety can proceed with prosecution. However, in case the sample is re-tested on Appeal and such re-testing before the Referral Lab returns a finding contrary to the finding of the Food Analyst, the report of the referral laboratory shall be final. Once the Commissioner decides to proceed with prosecution, a complaint is filed with the appropriate court and proceedings commence thereafter.
From the FBO's perspective, it is extremely important to analyse the entire chain of events minutely commencing from the stage of collection of the sample by FSO, the manner in which the sample was collected/ sealed/ stored, the labelling/ description/ representation of the product, nature of the product (ready to eat or raw material or intermediary), procedural compliances in the form of giving notices to all concerned, recording presence and signature of witnesses, etc. It may also be advisable for companies to arrange independent tests of samples carried out on random batches from time to time apart from other scientific evidence/ data to corroborate the claims/ position of the company. Needless to mention, such test methodology should be well established and widely accepted to add credibility and to enable companies to place reliance upon as may be necessary. Each of these stages are extremely critical as it may provide an opportunity to the FBO to challenge the action of the authorities under the Act at an appropriate stage so as to protect its interest.
Given that most companies invest substantially in building their reputation in the market and amongst their customers, any prosecution/ court proceedings can cause significant and irreparable damage to the goodwill and reputation of such companies and more importantly, the brand and the product concerned. In view of the increasing competition in the market and increasing focus on health, safety and hygiene of food products meant for human consumption, the role of quality control and checks cannot be overemphasised. However, the non-application of mind and mechanical manner of operation of certain authorities in gross abuse and misuse of the draconian powers vested under the Act also cannot be completely ruled out and the risks associated with operation in food business can only be attempted to be mitigated. Therefore, it is essential to utilize the relatively robust mechanism provided under the food safety framework and exercise the remedies provided therein. However, what is relevant and important is that one has to be vigilant and prompt in taking legal advice and swing into action without wasting much time in decision making/ liasioning/ representations as timing is critical to avoid any irreparable loss/ damage or being subjected to harassment in the form of unwanted prosecution.
1. See Section 3(1)(n) and (o) of the Act
2. See Section 26 and 27 of the Act
3. See Section 3(1)(t) of the Act
4. See Section 38 of the Act
5. Section 47 of the act read with Rule 2.4.1
6. See Rule 2.4.1 of the Rules
7. Section 46 of the Act
8. See Dharampal Satyapal Ltd. Vs State of Kerala [2014 SCC OnLine Ker 28567] and K.N.Jagadesan vs The Designated Officer [W.P.(MD).No.1880 of 2021] [Madras High Court]
The content of this document do not necessarily reflect the views/position of Khaitan & Co but remain solely those of the author(s). For any further queries or follow up please contact Khaitan & Co at firstname.lastname@example.org