ORDER : Anil K. Narendran, J. I.A.No.3 of 2023 This interlocutory application is one filed by Travancore Devaswom Board and its officials, respondents 1 to 4 in W.P.(C)No.41743 of 2022, seeking permission to draw samples from the stock of Aravana Prasadam kept sealed pursuant to the orders of this Court dated 11.01.2023, through the Food Safety Officers and send the same to analysis to any laboratory accredited by the Food Safety Authority of India to test whether Aravana Prasadam conforms to the food standards prescribed by the Food Safety and Standards Authority of India and safe for human consumption. 2. Along with the memo dated 07.02.2023 of the learned Central Government Counsel, report No.P.15017/15/2023-FSSAI/Legal dated 10.02.2023 of the Deputy Director, Food Safety Standards Authority of India, in response to I.A.No.3 of 2023 is placed on record, wherein it is stated that as per sub-section (2) of Section 26 of the Act the onus is on the food business operators, who have to comply with the provisions of the Act, Rules and Regulations. According to the conditions of licence at Annexure 3 of Food Safety and Standards (Licensing and Registration of Food Business) Regulations, 2011 raw material used by food business operators shall be of optimum quality. Therefore, any raw material used in the preparation of food shall comply with all the standards specified under the Food Safety Standard Regulations. Further as per Section 3(zz)(i) if the food article is composed of unsafe ingredients whether wholly or in part, the article of food is considered unsafe food. In the instant case, Cardamom used as a raw material of the end product, i.e., Aravana shall be of optimum quality. The Cardamom used for the preparation of Aravana has been declared unsafe vide Report dated 11.01.2023 due to the presence of pesticides which exceeds the Maximum Residue Limits (MRL) prescribed by the Food Safety and Standards Authority of India. MRLs of a pesticide for a food commodity, irrespective of the fact that it may be directly consumed or used as an ingredient in another food, is fixed while taking into consideration the overall dietary intake of pesticides through consumption of different food commodities to ensure the safety of food products. Therefore, unsafe raw materials shall not be used in the preparation of any article of food. 3. Therefore, unsafe raw materials shall not be used in the preparation of any article of food. 3. After the filing of this interlocutory application, the 2nd respondent herein, who is the 5th respondent-contractor in W.P.(C)No.41743 of 2022, filed a counter affidavit dated 14.02.2023 in the writ petition. The applicants/additional respondents 1 to 4 have filed an additional counter affidavit dated 15.02.2023 in the writ petition. 4. Heard the learned Standing Counsel for Travancore Devaswom Board for the applicants-respondents 1 to 4, the learned counsel for the 1st respondent-writ petitioner, the learned counsel for the 2nd respondent-contractor, the learned Senior Government Pleader for the State and its officials and the learned Central Government Counsel for the Central Government and Food Safety and Standards Authority of India. 5. The 1st respondent herein, who was the supplier of cardamom to the Travancore Devaswom Board, during the Mandala-Makaravilakku festival season of 1197 ME (2021-22), has filed W.P.(C)No.41743 of 2022, invoking the writ jurisdiction under Article 226 of the Constitution of India, seeking a writ of mandamus commanding the Travancore Devaswom Board to conduct an analysis of the cardamom, which was purchased after the cancellation of the tender conducted pursuant to Ext.P9 e-tender notification dated 12.10.2022, during Mandala-Makaravilakku festival season of 1198 ME (2022-23), at Government Analytical Laboratory, Thiruvananthapuram, under the supervision of this Court. The petitioner has also sought for a writ of certiorari to quash the proceedings of the Travancore Devaswom Board for local purchase of cardamom, at Sabarimala Devaswom, during Mandala-Makaravilakku festival season of 1198 ME (2022-23), as it was done without competition and newspaper advertisement. 6. The 2nd respondent herein, who is the 5th respondent in the writ petition, is supplying cardamom at Sabarimala, during Mandala-Makaravilakku festival season of 1198 ME (2022-23), pursuant to Ext.R1(A) notification dated 04.11.2022 issued by the Executive Officer, Sabarimala Devaswom, inviting quotations along with samples for supply of 15,000 kg. of cardamom at Sabarimala during Mandala-Makaravilakku festival season of 1198 ME (2022-23). The said notification is one issued after three successive e-tender notifications, i.e., Exts.P3, P6 and P9 notifications, for the supply of cardamom at Sabarimala, for the period from 01.11.2022 to 30.09.2023. 7. On 21.12.2022, when W.P.(C)No.41743 of 2022 came up for admission, the learned Standing Counsel for Travancore Devaswom Board took notice on admission for respondents 1 to 4. The said notification is one issued after three successive e-tender notifications, i.e., Exts.P3, P6 and P9 notifications, for the supply of cardamom at Sabarimala, for the period from 01.11.2022 to 30.09.2023. 7. On 21.12.2022, when W.P.(C)No.41743 of 2022 came up for admission, the learned Standing Counsel for Travancore Devaswom Board took notice on admission for respondents 1 to 4. Urgent notice by special messenger was ordered to the 5th respondent-contractor, the 2nd respondent in this interlocutory application, returnable by 23.12.2022. In W.P.(C)No. 41743 of 2022, this Court passed an order dated 23.12.2022, whereby the sample of cardamom supplied by the contractor was sent to the Government Analyst’s Laboratory, Thiruvananthapuram, for testing. As per the opinion of the Food Analyst in the certificate of the examination dated 28.12.2022, the sample contains the insecticide residues Fipronil, Tebuconazole and Imidacloprid to an extent of not less than 0.061 mg/kg, 0.792 mg/kg and 0.795 mg/kg respectively, which exceeds the MRL (Maximum Residue Limit) as per Regulation 2.3.1 of Food Safety and Standards (Contaminants Toxins and Residues) Regulations 2011, read with Note [Std/SP-02/Technical Matter/ 2021-22[E-4311] of FSSAI dated 21st April 2022] and is therefore unsafe as per Section 3(1)(zz)(iii)&(xii) of Food Safety and Standards Act 2006. 8. In the order dated 05.01.2023 in W.P.(C)No.41743 of 2022, this Court noticed that the opinion of the Food Analyst in Ext.R1(g) certificate of examination is with reference to Std/SP-02/Technical Matter/2021-22 [E-4311] of FSSAI dated 21.04.2022 of the Advisor (Science and Standards), Food Safety and Standards Authority of India, which deals with maximum residue limits for Spices and Culinary Herbs. The Executive Director (Compliance Strategy) of Food Safety and Standards Authority of India has issued a clarification dated 11.01.2021, regarding tolerance limit in cases of insecticides for which Maximum Residue Limits (MRLs) have not been fixed. In the said clarification, which is one issued with the approval of the Competent Authority, it is clarified that MRLs of 213 insecticides given in the Table and Tolerance Limit of 0.01 mg/kg mentioned in the Note pertain to agricultural commodities and the resultant physically processed foods only. The said MRLs and tolerance limit do not apply to the thermally and chemically processed foods. On 05.01.2023, the learned Central Government Counsel sought time to get instructions from the Food Safety and Standards Authority of India on Ext.R1(f) certificate of examination dated 28.12.2022, with specific reference to the clarification dated 11.01.2021. 9. The said MRLs and tolerance limit do not apply to the thermally and chemically processed foods. On 05.01.2023, the learned Central Government Counsel sought time to get instructions from the Food Safety and Standards Authority of India on Ext.R1(f) certificate of examination dated 28.12.2022, with specific reference to the clarification dated 11.01.2021. 9. By the order dated 06.01.2023 in W.P.(C)No.41743 of 2022, this Court directed the Food Safety Officer at Sannidhanam, under the Commissioner of Food Safety, Kerala, the 4th respondent herein, to collect samples of cardamom supplied by the contractor, the 2nd respondent herein, on 07.01.2023, in the presence of the Executive Magistrate, the Executive Officer, Sabarimala, and also the 2nd respondent-contractor or his authorised representative, after complying with the statutory requirements. The sample so taken were directed to be sent to the accredited laboratory of the Food Safety and Standards Authority of India at Kochi, through an officer authorised by the 4th respondent Commissioner of Food Safety, which shall be subjected to analysis on 07.01.2023 itself, with reference to the provisions under the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011 and also the Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011, and the test result shall be forwarded to the 7th respondent Food Safety and Standards Authority of India, from the accredited laboratory at Kochi. On receipt of the test result, the Executive Director, the Food Safety and Standards Authority of India, shall place the same before the Advisor (Quality Assurance) and the report/opinion of the said Authority shall be made available for the perusal of this Court on 09.01.2023. 10. In terms of the order dated 06.01.2023 in W.P.(C)No.41743 of 2022, another sample of cardamom supplied by the contractor, the 2nd respondent herein, was sent for testing to the accredited laboratory of the Food Safety and Standards Authority of India. Since facilities are not available in the primary accredited laboratory at Kochi, the sample was sent to a referral laboratory, i.e., Quality Evaluation Laboratory of the Spices Board at Kochi. In terms of the orders of this Court, the test report was forwarded to the Executive Director of the Food Safety and Standards Authority of India. Since facilities are not available in the primary accredited laboratory at Kochi, the sample was sent to a referral laboratory, i.e., Quality Evaluation Laboratory of the Spices Board at Kochi. In terms of the orders of this Court, the test report was forwarded to the Executive Director of the Food Safety and Standards Authority of India. On 11.01.2023, when W.P.(C)No.41743 of 2022 came up for consideration, the learned Central Government Counsel has placed on record, along with a memo dated 11.01.2023, the test report dated 10.01.2023 issued by the Quality Evaluation Laboratory of the Spices Board at Kochi and also the report dated 11.01.2023 of the Executive Director, Food Safety and Standards Authority of India. In the report of the Executive Director of the Food Safety and Standards Authority of India, the opinion by Advisor (QA) is extracted, as per which, in the tests conducted in the Quality Evaluation Laboratory, Spices Board, Kochi, 14 pesticides are found to be exceeding the MRL (Minimum Residual Limit) as specified under Food Safety and Standards (Contaminants, Toxins and Residues) Regulation, 2011. In addition, as per FSS (Contaminants, Toxins and Residues) Regulation, 2011, MRL/limit of six pesticides (Copper sulphate, copper oxychloride, Diafenthiuron, Fosetyl-Al, Monocrotophos and Quinalphos) specially for cardamom is defined. Out of above, two (Monocrotophos and Quinalphos) were tested by the Quality Evaluation Laboratory, in which the sample is exceeding the limit for Quinalphos. Tolerance limit of 0.01 mg/kg shall apply in cases of pesticides for which MRL have not been fixed. In view of the above, the sample is not conforming to regulation 2.3.1 of FSS (Contaminants, Toxins and Residues) Regulation, 2011 and amendments thereon. Therefore, the sample is unsafe as per Section 3(1)(zz)(xii) of the Food Safety and Standards Act, 2006. 11. The report dated 11.01.2023 of the Executive Director of the Food Safety and Standards Authority of India makes it explicitly clear that the sample of cardamom taken from the cardamom supplied by the 2nd respondent herein is not conforming to Regulation 2.3.1. of the Food Safety Standards (Contaminants, Toxins and Residues) Regulations, 2011 and the amendments thereon, which is unsafe as per Section 3(1)(zz)(xii) of the Food Safety and Standards Act, 2006. 12. of the Food Safety Standards (Contaminants, Toxins and Residues) Regulations, 2011 and the amendments thereon, which is unsafe as per Section 3(1)(zz)(xii) of the Food Safety and Standards Act, 2006. 12. On 11.01.2023, the learned Standing Counsel for Travancore Devaswom Board submitted that, in one ‘koottu’ for Aravana Prasadam, which consists of ingredients like rice, jaggery, etc., of approximately 350 kg, the quantity of cardamom is only 720 gms. Moreover, Aravana Prasadam is prepared in the plant by heating the ingredients at a temperature above 200 degrees. Since the end product, i.e., Aravana Prasadam, contains only a negligible quantity of cardamom, the fact that the cardamom supplied by the 2nd respondent herein contained pesticides exceeding the Maximum Residue Limit, will not make it unsafe for consumption, especially when it is prepared by heating the ingredients at a temperature above 200 degrees. The learned Standing Counsel submitted that Aravana Prasadam made with the cardamom supplied by the 2nd respondent herein may be ordered to be tested at the Government Analyst’s Laboratory, Thiruvananthapuram. 13. In the order dated 11.01.2023 in W.P.(C)No.41743 of 2022 this Court noticed that once the sample taken from the cardamom supplied by the 2nd respondent herein is found not conforming to Regulation 2.3.1. of the Food Safety Standards (Contaminants, Toxins and Residues) Regulations, 2011 and the amendments thereon, which is unsafe as per Section 3(1)(zz)(xii) of the Food Safety and Standards Act, 2006, the Travancore Devaswom Board cannot be permitted to sell Aravana Prasadam made using that cardamom to the devotees, even if in one ‘koottu’ for Aravana Prasadam, which consists of ingredients like rice, jaggery, etc., of approximately 350 kg., the quantity of cardamom is only 720 gms., and Aravana Prasadam is prepared in the plant by heating the ingredients at a temperature above 200 degrees. 14. In such circumstances, by the interim order dated 11.01.2023 in W.P.(C)No.41743 of 2022, this Court restrained the Travancore Devaswom Board from selling Aravana Prasadam made using the cardamom supplied by the 2nd respondent herein, to the pilgrims. This Court directed the Commissioner of Food Safety, the 4th respondent herein, through the Food Safety Officer at Sannidhanam, to take necessary steps to ensure that Aravana Prasadam made using the cardamom supplied by the 1st respondent contractor is not sold to the pilgrims. This Court directed the Commissioner of Food Safety, the 4th respondent herein, through the Food Safety Officer at Sannidhanam, to take necessary steps to ensure that Aravana Prasadam made using the cardamom supplied by the 1st respondent contractor is not sold to the pilgrims. Necessary steps in that regard were directed to be taken forthwith, without awaiting receipt of a copy of the order dated 11.01.2023. The learned Senior Government Pleader and the learned Standing Counsel for Travancore Devaswom Board were directed to communicate telephonically the directions contained in the order dated 11.01.2023 to the officers concerned forthwith. It was made clear that the order dated 11.01.2023 will not stand in the way of the Travancore Devaswom Board in making Aravana Prasadam without cardamom or after procuring cardamom, which meets the standards prescribed in the Regulations framed under the Food Safety and Standards Act, 2006, after obtaining test report from the Government Analyst’s Laboratory, Thiruvananthapuram. 15. On 13.01.2023, when W.P.(C)No.41743 of 2022 came up for consideration, the Commissioner of Food Safety, Kerala filed a compliance report, wherein it is stated that the Food Safety Squad inspected the Aravana Prasadam distribution counters situated near Aazhi and Malikappuram on 11.01.2023 and directed the Executive Officer, Sabarimala Devaswom, to stop the sale of the existing stock of Aravana Prasadam and accordingly the Devaswom Board authorities stopped the sale of Aravana Prasadam. The Food Safety Squad conducted a detailed inspection of the counters near Aazhi, Malikappuram and the godown situated at Malikappuram, old Annadana Mandapam. Based on the statement received from the Devaswom Authorities, a total stock of 6,65,159 cans bearing batch Nos.62 to 69 were found in various counters and adjacent godowns. Along with this, a stock of 800 gms. cardamom and a stock of 43.920 kg. cardamom powder were found in the Devaswom main stall. A spot mahazar was prepared and the godown was sealed and locked in the presence of witnesses and the key was handed over to the Executive Officer with a direction, entrusting him the sole responsibility of safe custody of 6,65,159 cans of Aravana Prasadam, 800 gms. of cardamom and 43.920 kg. of cardamom powder. Production of a fresh batch of Aravana Prasadam, (batch no.70) started at the Aravana Prasadam preparation plant without using cardamom, under the supervision of the Food Safety Special Squad. of cardamom and 43.920 kg. of cardamom powder. Production of a fresh batch of Aravana Prasadam, (batch no.70) started at the Aravana Prasadam preparation plant without using cardamom, under the supervision of the Food Safety Special Squad. At 3.30 a.m, on 12.01.2023, and sale of Aravana Prasadam with batch No.70 was resumed at the prasadam counter situated near Aazhi. All procedures ended at 4.00 p.m. on 12.01.2023. 16. On 13.01.2023, when W.P.(C)No.41743 of 2022 came up for consideration, compliance report filed by the Commissioner of Food Safety was placed on record. By the order dated 13.01.2023, the learned Senior Government Pleader was directed to get instructions as to the testing facilities available at the laboratory at Pamba, under the Food Safety Commissionerate, Kerala, and the learned Standing Counsel for Travancore Devaswom Board was directed to make available for the perusal of this Court, the entire files relating to the tender process pursuant to Exts.P3, P6 and P9 and also Ext.R1(a) notification dated 04.11.2022, on the next posting date. 17. On 17.01.2023, when W.P.(C)No.41743 of 2022 came up for consideration, the learned Standing Counsel for Travancore Devaswom Board produced the files relating to the tender process pursuant to Exts.P3, P6 and P9 and also Ext.R1(a) notification dated 04.11.2022. Registry was directed to keep the files in the safe custody of Registrar (Judicial) and the writ petition was ordered to be listed on 19.01.2023 for further consideration. 18. On 19.01.2023, when W.P.(C)No.41743 of 2022 came up for consideration, we have perused the files handed over by the learned Standing Counsel for Travancore Devaswom Board. As per the relevant files, there were three e-tender notifications for procuring cardamom and other items during Mandala-Makaravilakku festival season of 1198 ME (2022-23), i.e., Exts.P3, P6 and P9 e-tender notifications. In terms of the tender conditions in those e-tender notifications, the sample of cardamom taken from each supplier was sent for analysis before the Government Analyst’s Laboratory, Thiruvananthapuram. On all three occasions, the samples failed to meet the requirements under the Food Safety and Standards (Contaminants, Toxins and Residues) Regulation, 2011, since they contained residues exceeding the Maximum Residue Limit (MRL) as per the said Regulations. It is thereafter that a decision has been taken by the Travancore Devaswom Board, whereby the Executive Officer, Sabarimala Devaswom was authorised to procure cardamom and also certain other items, by local purchase. It is thereafter that a decision has been taken by the Travancore Devaswom Board, whereby the Executive Officer, Sabarimala Devaswom was authorised to procure cardamom and also certain other items, by local purchase. Instead of going for local purchase, the Executive Officer published a notification at Sannidhanam, inviting quotations from suppliers. Based on that notification, four quotations were received including that of the 2nd respondent herein. Out of the four samples of cardamom sent for analysis before the Laboratory at Pamba, under the Food Safety Commissionerate, Kerala, two samples failed to meet the requirements under the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. Out of the suppliers of other two samples, the price quoted by the 2nd respondent herein was the lowest. 19. On 19.01.2023, the learned Standing Counsel for Travancore Devaswom Board submitted that since the price quoted by the 2nd respondent herein for supply of cardamom was the lowest, the Executive Officer placed the proposal of the 2nd respondent herein for supply of cardamom, before the Devaswom Commissioner for negotiation. The Devaswom Commissioner negotiated with the 2nd respondent herein and thereafter, the matter was placed before the Travancore Devaswom Board for further negotiation. The decision taken by the Board to accept the proposal of the 2nd respondent herein was communicated to the Executive Officer, through the Devaswom Commissioner. Based on that decision, the Executive Officer issued supply order to the 2nd respondent herein for supply of cardamom. In the order dated 19.01.2023, we noticed that, a perusal of the files relating to Exts.P3, P6 and P9 e-tender notifications and also Ext.R1(a) notification would show that a similar procedure has been followed in respect of other items as well, during the Mandala-Makaravilakku festival season of 1198 ME. 20. In terms of the direction contained in the order dated 13.01.2023, the Commissioner of Food Safety has submitted a report dated 17.01.2023 as to the testing facilities available at the laboratory at Pamba, under the Food Safety Commissionerate, Kerala. In the said report it is stated that this Court ordered in SSCR No.1 of 2012 that the production, making and handling of Aravana shall be in strict conformity with the contents of the report of the learned Ombudsman and the report of the Commissioner of Food Safety, Kerala. In the said report it is stated that this Court ordered in SSCR No.1 of 2012 that the production, making and handling of Aravana shall be in strict conformity with the contents of the report of the learned Ombudsman and the report of the Commissioner of Food Safety, Kerala. It was further ordered that testing labs shall be functional during the monthly pooja period also apart from Mandala-Makaravilakku season for a complete regulatory measure in place regarding the procurement of raw materials, manufacture, packing and handling of Aravana in Sabarimala. Having regard to the order passed in SSCR No.1 of 2012 and the report of the Joint Commissioner of Food Safety, this Court directed the Travancore Devaswom Board to ensure that the standards prescribed by the Food Safety Commissionerate, Kerala for preparation of Aravana are maintained scrupulously and in any case any batch of Aravana is found to be not conforming to the standards, the same shall not be distributed to the devotees. On the basis of the directions issued by this Court, two analytical laboratories were set up at Pamba and Sannidhanam, which are functional since 2012, under the control of the Commissioner of Food Safety, Kerala. Infrastructure for the analytical laboratories was provided by the Travancore Devaswom Board and technical and analytical staff were posted by the Commissioner of Food Safety. All raw materials for Aravana are being stored at Pamba godown and being analysed at the Analytical Laboratory at Pamba. The raw materials conforming to the standards alone are transported to Sannidhanam for the preparation of Aravana and Appam. If any re-examination is needed, the article will be analysed at Government Analyst’s Laboratory, Thiruvananthapuram for confirmation of test results. The prepared Aravana and Appam are being analysed at the Analytical Laboratory in Sannidhanam. As per the report dated 17.01.2023 of the Commissioner of Food Safety, Kerala, the Analytical Laboratory at Pamba has the facility to test the quality standards and synthetic food colour of raw materials used for preparation of prasadam, which includes Cardamom. In respect of Cardamom, the following parameters are being tested at Pamba. “1. Mould growth & Rodent contamination 2. Dead and living insects, Insect fragments 3. Extraneous matter 4. Empty and malformed capsules by count 5. Moisture 6. Total ash on dry weight basis 7. Volatile oil content on dry weight basis 8. Test for synthetic food colour 9. Insect damaged matter 10. “1. Mould growth & Rodent contamination 2. Dead and living insects, Insect fragments 3. Extraneous matter 4. Empty and malformed capsules by count 5. Moisture 6. Total ash on dry weight basis 7. Volatile oil content on dry weight basis 8. Test for synthetic food colour 9. Insect damaged matter 10. Immature and shrivelled capsules.” The equipment available in the analytical laboratories at Pamba to test the quality parameters for Aravana and that available at Sannidhanam to test the quality parameters for Aravana are furnished in the report dated 17.01.2023 of the Commissioner of Food Safety. 21. In the order dated 19.01.2023, we noticed that the facilities for testing cardamom and other items with reference to the requirements of the Food Safety and Standards (Contaminants, Toxins and Residues) Regulation, 2011, are not available at the Laboratory at Pamba, under the Food Safety Commissionerate, Kerala, where the testing parameters are with reference to the provisions under the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. When the samples of cardamom in respect of Exts.P3, P6 and P9 e-tender notifications failed to meet the requirements of the Food Safety and Standards (Contaminants, Toxins and Residues) Regulation, 2011, in the testing conducted at Government Analyst’s Laboratory, Thiruvananthapuram, even when it is decided by the Travancore Devaswom Board to go for local purchase for procuring cardamom and other items, before accepting the quotations by the suppliers, the Board should have ensured that the sample of cardamom meets the requirements of the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 and also the requirements under the Food Safety and Standards (Contaminants, Toxins and Residues) Regulation, 2011. 22. In the order dated 19.01.2023 in W.P.(C)No.41743 of 2022, we found that a proper food safety audit at Sabarimala is highly essential in order to ensure strict compliance of the statutory requirements of the Food Safety and Standards Act, 2006 and also the Rules and Regulations made thereunder, including the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 and the Food Safety and Standards (Contaminants, Toxins and Residues) Regulation, 2011. In such circumstances, by the order dated 19.01.2023, we directed Registry to register a suo motu proceedings in order to ensure strict compliance of the statutory requirements of the Food Safety and Standards Act, 2006 and also the Rules and Regulations made thereunder, including the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 and the Food Safety and Standards (Contaminants, Toxins and Residues) Regulation, 2011 at Sabarimala in the preparation of Aravana Prasadam, Appam Prasadam, etc., which is now pending consideration as DBP No.4 of 2023. 23. Food Safety and Standards Act, 2006 (for brevity, ‘the Act’) is enacted by Parliament to consolidate the laws relating to food and to establish the Food Safety and Standards Authority of India for laying down science-based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import, to ensure availability of safe and wholesome food for human consumption and for matters connected therewith or incidental thereto. 24. In Centre for Public Interest Litigation v. Union of India and others [ (2013) 16 SCC 279 ], the Apex Court held that any food article which is hazardous or injurious to public health is a potential danger to the fundamental right to life guaranteed under Article 21 of the Constitution of India. A paramount duty is cast on the States and its authorities to achieve an appropriate level of protection to human life and health which is a fundamental right guaranteed to the citizens under Article 21 read with Article 47 of the Constitution of India. 25. In Swami Achyutanand Tirth v. Union of India [ (2016) 9 SCC 699 ] the Apex Court noticed that some of the objectives of the Food Safety and Standards Act are as follows; (i) to consolidate the laws relating to food, (ii) to establish Food Safety and Standards Authority of India for laying down science-based standards for articles of food, (iii) to regulate their manufacture, storage, distribution, sale and import, (iv) to ensure availability of safe and wholesome food for human consumption. The Act, apart from making more stringent provisions (e.g. prescribing higher penalties, etc.) to curb food adulteration, also ushers in new concepts such as putting in place food safety management systems and food safety audits to realise its ultimate goal of ensuring the availability of safe and wholesome food for human consumption. The Act, apart from making more stringent provisions (e.g. prescribing higher penalties, etc.) to curb food adulteration, also ushers in new concepts such as putting in place food safety management systems and food safety audits to realise its ultimate goal of ensuring the availability of safe and wholesome food for human consumption. In order to ensure food safety, effective food safety systems implementation and to ensure that food producers and suppliers operate responsibly and supply safe food to consumers, the Act further stipulates (i) licensing for the manufacture of food products, which is presently granted by the Central agencies under various Acts and orders, would stand decentralised to the Commissioner of Food Safety and his office, (ii) single reference point for all matters relating to food safety and standards, regulations and enforcement, (iii) shift from mere regulatory regime to self-compliance through food safety management systems, (iv) responsibility on food business operators to ensure that food processed, manufactured, imported or distributed is in compliance with the domestic food laws. 26. Clause (a) of Section 3(1) of the Act defines ‘adulterant’ to mean any material which is or could be employed for making the food unsafe or sub-standard or mis-branded or containing extraneous matter. Clause (g) of Section 3(1) of the Act defines ‘contaminant’ to mean any substance, whether or not added to food, but which is present in such food as a result of the production (including operations carried out in crop husbandry, animal husbandry or veterinary medicine), manufacture, processing, preparation, treatment, packing, packaging, transport or holding of such food or as a result of environmental contamination and does not include insect fragments, rodent hairs and other extraneous matter. 27. Clause (j) of Section 3(1) of the Act defines ‘food’ to mean any substance, whether processed, partially processed or unprocessed, which is intended for human consumption and includes primary food to the extent defined in clause (zk), genetically modified or engineered food or food containing such ingredients, infant food, packaged drinking water, alcoholic drink, chewing gum, and any substance, including water used into the food during its manufacture, preparation or treatment but does not include any animal feed, live animals unless they are prepared or processed for placing on the market for human consumption, plants prior to harvesting, drugs and medicinal products, cosmetics, narcotic or psychotropic substances. As per the proviso to clause (f) of Section 3(1), the Central Government may declare, by notification in the Official Gazette, any other article as food for the purposes of this Act having regards to its use, nature, substance or quality. 28. Clause (k) of Section 3(1) of the Act defines ‘food additive’ to mean any substance not normally consumed as a food by itself or used as a typical ingredient of the food, whether or not it has nutritive value, the intentional addition of which to food for a technological (including organoleptic) purpose in the manufacture, processing, preparation, treatment, packing packaging, transport or holding of such food results, or may be reasonably expected to result (directly or indirectly), in it or its by-products becoming a component of or otherwise affecting the characteristics of such food but does not include ‘contaminants’ or substances added to food for maintaining or improving nutritional qualities. 29. Clause (n) of Section 3(1) of the Act defines ‘food business’ to mean any undertaking, whether for profit or not and whether public or private, carrying out any of the activities related to any stage of manufacture, processing, packaging, storage, transportation, distribution of food, import and includes food services, catering services, sale of food or food ingredients. Clause (o) of Section 3(1) defines ‘food business operator’ in relation to food business to mean a person by whom the business is carried on or owned and is responsible for ensuring the compliance of the Act, rules and regulations made thereunder. 30. Clause (q) of Section 3(1) of the Act defines ‘food safety’ to mean an assurance that food is acceptable for human consumption according to its intended use. Clause (u) of Section 3(1) defines ‘hazard’ to mean a biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect. Clause (y) of Section 3(1) defines ‘ingredient’ to mean any substance, including a food additive used in the manufacture or preparation of food and present in the final product, possibly in a modified form. Clause (zc) of Section 3(1) defines ‘manufacture’ to mean a process or adoption or any treatment for conversion of ingredients into an article of food, which includes any sub-process, incidental or ancillary to the manufacture of an article of food. Clause (zc) of Section 3(1) defines ‘manufacture’ to mean a process or adoption or any treatment for conversion of ingredients into an article of food, which includes any sub-process, incidental or ancillary to the manufacture of an article of food. Clause (zd) of Section 3(1) defines ‘manufacturer’ to mean a person engaged in the business of manufacturing any article of food for sale and includes any person who obtains such article from another person and packs and labels it for sale or only labels it for such purposes. 31. Clause (zd) of Section 3(1) defines ‘manufacturer’ to mean a person engaged in the business of manufacturing any article of food for sale and includes any person who obtains such article from another person and packs and labels it for sale or only labels it for such purposes. 31. Clause (zf) of Section 3(1) of the Act defines ‘misbranded food’, which reads thus; “(zf) ‘misbranded food’ means an article of food- (A) if it is purported, or is represented to be, or is being- (i) offered or promoted for sale with false, misleading or deceptive claims either- (a) upon the label of the package, or (b) through advertisement, or (ii) sold by a name which belongs to another article of food; or (iii) offered or promoted for sale under the name of a fictitious individual or company as the manufacturer or producer of the article as borne on the package or containing the article or the label on such package; or (B) if the article is sold in packages which have been sealed or prepared by or at the instance of the manufacturer or producer bearing his name and address but- (i) the article is an imitation of, or is a substitute for, or resembles in a manner likely to deceive, another article of food under the name of which it is sold, and is not plainly and conspicuously labelled so as to indicate its true character; or (ii) the package containing the article or the label on the package bears any statement, design or device regarding the ingredients or the substances contained therein, which is false or misleading in any material particular, or if the package is otherwise deceptive with respect to its contents; or (iii) the article is offered for sale as the product of any place or country which is false; or (C) if the article contained in the package- (i) contains any artificial flavouring, colouring or chemical preservative and the package is without a declaratory label stating that fact is not labelled in accordance with the requirements of this Act or regulations made thereunder or is in contravention thereof; or (ii) is offered for sale for special dietary uses, unless its label bears such information as may be specified by regulation, concerning its vitamins, minerals or other dietary properties in order sufficiently to inform its purchaser as to its value for such use; or (iii) is not conspicuously or correctly stated on the outside thereof within the limits of variability laid down under this Act.” 32. Clause (zk) of Section 3(1) of the Act defines ‘primary food’ to mean an article of food, being a produce of agriculture or horticulture or animal husbandry and dairying or aquaculture in its natural form, resulting from the growing, raising, cultivation, picking, harvesting, collection or catching in the hands of a person other than a farmer or fisherman. Clause (zr) of Section 3(1) defines ‘sale’ with its grammatical variations and cognate expressions, means the sale of any article of food, whether for cash or on credit or by way of exchange and whether by wholesale or retail, for human consumption or use, or for analysis, and includes an agreement for sale, an offer for sale, the exposing for sale or having in possession for sale of any such article, and includes also an attempt to sell any such article. 33. Clause (zu) of Section 3(1) of the Act defines ‘standard’, in relation to any article of food, to mean the standards notified by the Food Authority, i.e., the Food Safety and Standards Authority of India established under Section 4 of the Act. Clause (zw) of Section 3(1) defines ‘substance’ to include any natural or artificial substance or other matter, whether it is in a solid state or in liquid form or in the form of gas or vapour. As per clause (zx) of Section 3(1), which defines ‘sub-standard’, an article of food shall be deemed to be sub-standard if it does not meet the specified standards but not so as to render the article of food unsafe. 34. As per clause (zx) of Section 3(1), which defines ‘sub-standard’, an article of food shall be deemed to be sub-standard if it does not meet the specified standards but not so as to render the article of food unsafe. 34. Clause (zz) of Section 3(1) of the Act defines ‘unsafe food’, which reads thus; “(zz) ‘unsafe food’ means an article of food whose name, substance or quality is so affected as to render it injurious to health:- (i) by the article itself, or its package thereof, which is composed, whether wholly or in part, of poisonous or deleterious substances; or (ii) by the article consisting, wholly or in part, of any filthy, putrid, rotten, decomposed or diseased animal substance or vegetable substance; or (iii) by virtue of its unhygienic processing or the presence in that article of any harmful substance; or (iv) by the substitution of any inferior or cheaper substance whether wholly or in part; or (v) by addition of a substance directly or as an ingredient which is not permitted; or (vi) by the abstraction, wholly or in part, of any of its constituents; or (vii) by the article being so coloured, flavoured or coated, powdered or polished, as to damage or conceal the article or to make it appear better or of greater value than it really is; or (viii) by the presence of any colouring matter or preservatives other than that specified in respect thereof; or (ix) by the article having been infected or infested with worms, weevils or insects; or (x) by virtue of its being prepared, packed or kept under insanitary conditions; or (xi) by virtue of its being misbranded or substandard or food containing extraneous matter; or (xii) by virtue of containing pesticides and other contaminants in excess of quantities specified by regulations.” 35. Section 16 of the Act deals with duties and functions of Food Authority, i.e., the Food Safety and Standards Authority of India established under Section 4 of the Act. As per sub-section (1) of Section 16, it shall be the duty of the Food Authority to regulate and monitor the manufacture, processing, distribution, sale and import of food so as to ensure safe and wholesome food. As per sub-section (2) of Section 16, without prejudice to the provisions of sub-section (1), the Food Authority may by regulations specify the matters enumerated in clauses (a) to (i). As per sub-section (2) of Section 16, without prejudice to the provisions of sub-section (1), the Food Authority may by regulations specify the matters enumerated in clauses (a) to (i). Such regulations may specify, as per clause (a), the standards and guidelines in relation to articles of food and an appropriate system for enforcing various standards notified under this Act; and as per clause (b), the limits for use of food additives, crop contaminants, pesticide residues, residues of veterinary drugs, heavy metals, processing aids, mycotoxins, antibiotics and pharmacological active substances and irradiation of food. As per sub-section (5) of Section 16, the Food Authority may, from time to time give such directions, on matters relating to food safety and standards, to the Commissioner of Food Safety, who shall be bound by such directions while exercising his powers under the Act. 36. Section 18 of the Act deals with general principles to be followed in the administration of the said Act. As per Section 18, the Central Government, the State Governments, the Food Authority and other agencies, as the case may be, while implementing the provisions of the Act shall be guided by the principles enumerated in clauses (a) to (g) of sub-section (1). While framing regulations or specifying standards under the Act, the Food Authority shall take into account the matters enumerated in clauses (a) to (f) of sub-section (2). As per sub-section (3) of Section 18, the provisions of the Act shall not apply to any farmer or fisherman or farming operations or crops or livestock or aquaculture, and supplies used or produced in farming of products of crops produced by a farmer at farm level or a fisherman in his operations. 37. Section 19 of the Act deals with use of food additives or processing aid. As per Section 19, no article of food shall contain any food additive or processing aid unless it is in accordance with the provisions of the Act and regulations made thereunder. 37. Section 19 of the Act deals with use of food additives or processing aid. As per Section 19, no article of food shall contain any food additive or processing aid unless it is in accordance with the provisions of the Act and regulations made thereunder. As per the Explanation to Section 19, for the purposes of this Section, ‘processing aid’ means any substance or material, not including apparatus or utensils, and not consumed as a food ingredient by itself, used in the processing of raw materials, foods or its ingredients to fulfil a certain technological purpose during treatment or processing and which may result in the non-intentional but unavoidable presence of residues or derivatives in the final product. 38. Section 20 of the Act deals with contaminants, naturally occurring toxic substances, heavy metals, etc. As per Section 20, no article of food shall contain any contaminant, naturally occurring toxic substances or toxins or hormones or heavy metals in excess of such quantities as may be specified by regulations. Section 21 of the Act deals with pesticides, veterinary drugs residues, antibiotic residues and micro-biological counts. As per sub-section (1) of Section 21, no article of food shall contain insecticides or pesticide residues, veterinary drugs residues, antibiotic residues, solvent residues, pharmacologically active substances and micro-biological counts in excess of such tolerance limits as may be specified by regulations. As per sub-section (2) of Section 21, no insecticide shall be used directly on an article of food except fumigants registered and approved under the Insecticides Act, 1968. As per the Explanation to Section 21 of the Act, for the purposes of this Section, ‘pesticide residue’ means any specified substance in food resulting from the use of a pesticide and includes any derivatives of a pesticide, such as conversion products, metabolites, reaction products and impurities considered to be of toxicological significance and also includes such residues coming into food from the environment; and ‘residues of veterinary drugs’ include the parent compounds or their metabolites or both in any edible portion of any animal product and include residues of associated impurities of the veterinary drug concerned. 39. Section 22 of the Act deals with genetically modified foods, organic foods, functional foods, proprietary foods, etc. 39. Section 22 of the Act deals with genetically modified foods, organic foods, functional foods, proprietary foods, etc. As per Section 22 of the Act, save as otherwise provided under the Act and regulations made thereunder, no person shall manufacture, distribute, sell or import any novel food, genetically modified articles of food, irradiated food, organic food, foods for special dietary uses, functional foods, neutraceuticals, health supplements, proprietary foods and such other articles of food which the Central Government may notify in this behalf. As per Explanation (4) to Section 22, ‘proprietary and novel food’ means an article of food for which standards have not been specified but is not unsafe. As per the proviso to Section 22, such food does not contain any of the foods and ingredients prohibited under the Act and the regulations made thereunder. 40. Section 26 of the Act deals with responsibilities of food business operator. As per sub-section (1) of Section 26, every food business operator shall ensure that the articles of food satisfy the requirements of the Act and the rules and regulations made thereunder at all stages of production, processing, import, distribution and sale within the businesses under his control. Section 26 of the Act reads thus; “26. Responsibilities of the food business operator.- (1) Every food business operator shall ensure that the articles of food satisfy the requirements of this Act and the rules and regulations made thereunder at all stages of production, processing, import, distribution and sale within the businesses under his control. (2) No food business operator shall himself or by any person on his behalf manufacture, store, sell or distribute any article of food- (i) which is unsafe; or (ii) which is misbranded or sub-standard or contains extraneous matter; or (iii) for which a licence is required, except in accordance with the conditions of the licence; or (iv) which is for the time being prohibited by the Food Authority or the Central Government or the State Government in the interest of public health; or (v) in contravention of any other provision of this Act or of any rule or regulation made thereunder. (3) No food business operator shall employ any person who is suffering from infectious, contagious or loathsome disease. (3) No food business operator shall employ any person who is suffering from infectious, contagious or loathsome disease. (4) No food business operator shall sell or offer for sale any article of food to any vendor unless he also gives a guarantee in writing in the form specified by regulations about the nature and quality of such article to the vendor: Provided that a bill, cash memo, or invoice in respect of the sale of any article of food given by a food business operator to the vendor shall be deemed to be a guarantee under this section, even if a guarantee in the specified form is not included in the bill, cash memo or invoice. (5) Where any food which is unsafe is part of a batch, lot or consignment of food of the same class or description, it shall be presumed that all the food in that batch, lot or consignment is also unsafe, unless following a detailed assessment within a specified time, it is found that there is no evidence that the rest of the batch, lot or consignment is unsafe: Provided that any conformity of a food with specific provisions applicable to that food shall be without prejudice to the competent authorities taking appropriate measures to impose restrictions on that food being placed on the market or to require its withdrawal from the market for the reasons to be recorded in writing where such authorities suspect that, despite the conformity, the food is unsafe.” 41. Section 27 of the Act deals with liability of manufacturers, packers, wholesalers, distributors and sellers. As per sub-section (1) of Section 27, the manufacturer or packer of an article of food shall be liable for such article of food if it does not meet the requirements of the Act and the rules and regulations made thereunder. Section 27 of the Act reads thus; “27. Liability of manufacturers, packers, wholesalers, distributors and sellers.- (1) The manufacturer or packer of an article of food shall be liable for such article of food if it does not meet the requirements of this Act and the rules and regulations made thereunder. Section 27 of the Act reads thus; “27. Liability of manufacturers, packers, wholesalers, distributors and sellers.- (1) The manufacturer or packer of an article of food shall be liable for such article of food if it does not meet the requirements of this Act and the rules and regulations made thereunder. (2) The wholesaler or distributor shall be liable under this Act for any article of food which is- (a) supplied after the date of its expiry; or (b) stored or supplied in violation of the safety instructions of the manufacturer; or (c) unsafe or misbranded; or (d) unidentifiable of manufacturer from whom the articles of food have been received; or (e) stored or handled or kept in violation of the provisions of this Act, the rules and regulations made thereunder; or (f) received by him with knowledge of being unsafe. (3) The seller shall be liable under this Act for any article of food which is- (a) sold after the date of its expiry; or (b) handled or kept in unhygienic conditions; or (c) misbranded; or (d) unidentifiable of the manufacturer or the distributors from whom such articles of food were received; or (e) received by him with knowledge of being unsafe.” 42. Section 91 of the Act deals with power of Central Government to make rules; Section 92 deals with power of Food Authority, i.e., the Food Safety and Standards Authority of India established under Section 4 of the Act, to make regulations; and Section 94 deals with power of State Government to make rules. As per Section 92(1) of the Act, the Food Authority may, with the previous approval of the Central Government and after previous publication, by notification, make regulations consistent with the Act and the rules made thereunder to carry out the provisions of this Act. As per clause (e) of sub-section (2) of Section 92, such regulations may provide for standards and guidelines in relation to articles of food meant for human consumption under sub-section (2) of Section 16; as per clause (i) of sub-section (2) of Section 92, limits of quantities of contaminants, toxic substances and heavy metals, etc. under Section 20; and as per clause (j) of sub-section (2) of Section 92, tolerance limits of pesticides, veterinary drugs residues, etc., under Section 21. 43. under Section 20; and as per clause (j) of sub-section (2) of Section 92, tolerance limits of pesticides, veterinary drugs residues, etc., under Section 21. 43. In exercise of the powers conferred by clauses (i) and (j) of sub-section (2) of Section 92 read with Sections 20 and 21 of Food Safety and Standards Act, 2006 (34 of 2006), the Food Safety and Standards Authority of India made Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011. Regulation 1.2. deals with definitions. Clause 1 of sub-regulation 1.2.1. defines ‘crop contaminant’ to mean any substance not intentionally added to food, but which gets added to articles of food in the process of their production (including operations carried out in crop husbandry, animal husbandry and veterinary medicine), manufacture, processing, preparation, treatment, packing, packaging transport or holding of articles of such food as a result of environmental contamination. Chapter 2 of the Regulations deals with contaminants, toxins and residues. Regulation 2.1. deals with metal contaminants; Regulation 2.2. deals with crop contaminants and naturally occurring toxic substances; and Regulation 2.3. deals with residues. 44. Sub-regulation 2.3.1. of Food Safety and Standards (Contaminants, Toxins and Residues) Regulations deals with restriction on the use of insecticides. As per clause (1) of Sub-regulation 2.3.1., the expression ‘insecticide’ shall have the meaning assigned to it in the Insecticides Act, 1968. As per clause (2), subject to the provisions of clause (3), no insecticides shall be used directly on articles of food. As per the proviso to clause (2), nothing in this regulation shall apply to the fumigants which are registered and recommended for use as such on articles of food by the Registration Committee constituted under Section 5 of the Insecticides Act. As per clause (3), the insecticide specified in column (2) of the table shall not exceed the Maximum Residue Limits (MRL) prescribed in column (4), for the article of food specified in column (3) of the said table. The Maximum Residue Limits (MRL) of insecticides specified in the said table for cardamom read thus; Sl.No. Name of Insecticides Food Maximum Residue Limits (MRL) in mg/kg 43. Copper Oxychloride (Copper determined as elemental copper) Cardamom $ 44. Copper Sulphate (Copper determined as elemental copper Cardamom $ 52. Diafenthiuron Cardamom 0.5 93. Fosetyl-Al Cardamom 0.2 129. Monocrotophos Cardamom 0.5 163. The Maximum Residue Limits (MRL) of insecticides specified in the said table for cardamom read thus; Sl.No. Name of Insecticides Food Maximum Residue Limits (MRL) in mg/kg 43. Copper Oxychloride (Copper determined as elemental copper) Cardamom $ 44. Copper Sulphate (Copper determined as elemental copper Cardamom $ 52. Diafenthiuron Cardamom 0.5 93. Fosetyl-Al Cardamom 0.2 129. Monocrotophos Cardamom 0.5 163. Quinalphos Cardamom 0.01 $: The limit shall be for copper in the regulations 2.1 metal contaminants of the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011 and as amended from time to time. Note: Tolerance limit of 0.01 mg/kg shall apply in cases of pesticides for which MRL have not been fixed. 45. In exercise of the powers conferred by clause (e) of sub-section (2) of Section 92, read with Section 16 of the Food Safety and Standards Act, the Food Safety and Standards Authority of India made the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. Regulation 2.9 deals with salt, spices, condiments and related products. Sub-regulation 2.9.2 deals with cardamom (elaichi), which reads thus; 2.9.2 Cardamom (Elaichi): 1. Cardamom (Chhoti Elaichi) Whole means the dried capsules of nearly ripe fruits of Elettaria cardamomum L. Maton Var. Minuscula Burkill. The capsules may be light green to brown or pale cream to white when bleached with sulphur dioxide. It shall have characteristic flavour free from any foreign odour, mustiness or rancidity. It shall be free from mould, living and dead insects, insect fragments, rodent contamination. Thrip marks alone should not lead to the conclusion that the capsules have been infested with insects. The product shall be free from added colouring matter and other harmful substances. It shall conform to the following standards:- (i) Extraneous matter Not more than 1.0% by weight (ii) Empty and malformed capsules by count Not more than 3.0% by count (iii) Immature and shrivelled capsules Not more than 3.0% by weight (iv) Moisture Not more than 13.0% by weight (v) Total ash on dry basis Not more than 9.5% by weight (vi) Volatile oil content on dry basis Not less than 3.5% by v/w (vii) Insect damaged matter Not more than 1.0% by weight 2. Cardamom (Chhoti Elaichi) seeds means the decorticated seeds separated from the dried capsules of nearly ripe fruits of Elettaria Cardamomum L. Maton var miniscula Burkill. Cardamom (Chhoti Elaichi) seeds means the decorticated seeds separated from the dried capsules of nearly ripe fruits of Elettaria Cardamomum L. Maton var miniscula Burkill. The seeds shall have characteristic flavour free from foreign odour, mustiness or rancidity. It shall be free from mould, living and dead insects, insect fragments, rodent contamination. The product shall be free from added colouring matter and any other harmful substances. It shall conform to the following standards:- (i) Extraneous matter Not more than 2.0% by weight (ii) Light seeds Not more than 3.0% by weight (iii) Moisture Not more than 13.0% by weight (iv) Total ash on dry basis Not more than 9.5% by weight (v) Volatile oil content on dry basis Not less than 3.5% by v/w (vi) Insect damaged matter Not more than 1.0% by weight Explanation.—Light seeds mean seeds that are brown or red in colour and broken immature and shrivelled seeds. 3. Cardamom (Chhoti Elaichi) powder means the powder obtained by grinding dried seeds of Elettaria Cardamomum L. Maton var miniscula Burkill without addition of any other substance. It may be in the form of small pieces of seeds or in finely ground form. It shall have characteristic flavour free from foreign odour, mustiness or rancidity. It shall be free from mould, living and dead insects, insect fragments, rodent contamination. The powder shall be free from added colouring matter and other harmful substances. It shall conform to the following standards:- (i) Moisture Not more than 11.0% by weight (ii) Total ash on dry basis Not more than 8.0% by weight (iii) Ash insoluble in dilute HCl on dry basis Not more than 3.0% by weight (iv) Volatile oil content on dry basis Not less than 3.0% by v/w 4. Large Cardamom (Badi Elaichi) whole means the dried nearly ripe fruit (capsule) of Amomum subulatum Roxb. The capsule shall have characteristic flavour free from foreign odour, mustiness and rancidity. It shall be free from mould, living and dead insects, insect fragments, rodent contamination. The product shall be free from added colouring matter and any harmful substance. Large Cardamom (Badi Elaichi) whole means the dried nearly ripe fruit (capsule) of Amomum subulatum Roxb. The capsule shall have characteristic flavour free from foreign odour, mustiness and rancidity. It shall be free from mould, living and dead insects, insect fragments, rodent contamination. The product shall be free from added colouring matter and any harmful substance. It shall conform to the following standards:- (i) Extraneous matter Not more than 1.0% by weight (ii) Empty and malformed capsules by count Not more than 2.0% by count (iii) Immature and shrivelled capsules Not more than 2.0% by weight (iv) Moisture Not more than 12.0% by weight (v) Ash insoluble in dilute HCl on dry basis Not more than 2% by weight (vi) Total ash on dry basis Not more than 8% by weight (vii) Volatile oil content of seeds on dry basis Not less than 1.0 % by v/w (viii) Insect damaged matter Not more than 1.0% by weight 5. Large Cardamom (Badi Elaichi) seeds means the seeds obtained by decortication of capsules of Amomum subulatum Roxb. It shall have characteristic flavour free from foreign odour, mustiness and rancidity. It shall be free from mould, living and dead insects, insect fragments, rodent contamination. The product shall be free from added colouring matter and other harmful substances. It shall conform to the following standards:- (i) Extraneous matter Not more than 2.0% by weight (ii) Light seeds/Brown/Red seeds Not more than 3.0% by weight (iii) Moisture Not more than 12.0% by weight (iv) Total ash on dry basis Not more than 8.0% by weight (v) Ash insoluble in dilute HCl on dry basis Not more than 2.0% by weight (vi) Volatile oil content on dry basis Not less than 1.0% by v/w (vii) Insect damaged matter Not more than 1.0% by weight 6. Large Cardamom (Badi Elaichi) powder means the powder obtained by grinding seeds of Amomum subulatum Roxb, without the addition of any other substance. It may be in the form of small pieces of seeds or in finely ground form. The powder shall have characteristic flavour free from off flavour, mustiness and rancidity. It shall be free from mould, living and dead insects, insect fragments, rodent contamination. The powder shall be free from added colouring matter and any harmful substance. It may be in the form of small pieces of seeds or in finely ground form. The powder shall have characteristic flavour free from off flavour, mustiness and rancidity. It shall be free from mould, living and dead insects, insect fragments, rodent contamination. The powder shall be free from added colouring matter and any harmful substance. It shall conform to the following standards:- (i) Moisture Not more than 11.0% by weight (ii) Total ash on dry basis Not more than 8.0% by weight (iii) Ash insoluble in dilute HCl on dry basis Not more than 2.0% by weight (iv) Volatile oil content on dry basis Not less than 1.0% by weight 46. Regulation 2.12 of the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 deals with proprietary food. Regulation 2.12 reads thus; “2.12: Proprietary food 2.12.1: For the purpose of these regulations.- (1) Proprietary food means an article of food that has not been standardised under these regulations, but does not include novel foods, foods for special dietary uses, foods for special medical purposes, functional foods, nutraceuticals, health supplements and such other food articles which the Central Government may notify in this behalf: Provided that any deviation in quality parameters of a standardised food, as specified in the Food Safety and Standards Regulations made under the Food Safety and Standards Act, 2006 shall not qualify the resultant product as a proprietary food. (2) Proprietary food shall contain only those ingredients other than additives which are either standardised or permitted for use in the preparation of food products under the Food Safety Standards and Regulations and those food or ingredients mentioned in the Indian Food Composition Tables (IFCT), 2017, National Institute of Nutrition, except the ingredients which may be specified by the Authority from time to time and those specified under prohibition of hunting in the Indian Wildlife Protection Act, 1972 (53 of 1972): Provided that a proprietary food may also contain vitamins and minerals in quantities not exceeding one Recommended Dietary Allowance of the respective micronutrients. (3) Proprietary food shall use only such additives and at such levels, as specified for the category or sub-category under Appendix A of these regulations, to which the food belongs. Such category or sub-category shall be clearly mentioned on the label along with the generic name, nature and composition of the proprietary food. (3) Proprietary food shall use only such additives and at such levels, as specified for the category or sub-category under Appendix A of these regulations, to which the food belongs. Such category or sub-category shall be clearly mentioned on the label along with the generic name, nature and composition of the proprietary food. (4) Proprietary food shall comply with the microbiological requirements as specified in Appendix B of these regulations. If no microbiological standards are specified for any foods or food categories in Appendix B of these regulations, proprietary foods falling under such food categories shall not contain any pathogenic microorganism at a level that may render the food product unsafe. (5) Proprietary food shall also comply with the provisions, as applicable, of all other Regulations made under the Food Safety and Standards Act, 2006. No health claims shall be made in respect of proprietary foods either on the product label or otherwise, unless it is substantiated by adequate and scientific evidence. (6) The Food Business Operator shall be fully responsible for safety of the proprietary food in respect of human consumption.” 47. Prepared foods fall under category 16.0 in Appendix A of the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. Category 16.0 in Appendix A reads thus; “16.0 Prepared foods.- These foods are not included in the other food categories (1-15) and shall be considered on a case by case basis. Prepared foods are mixtures of multiple components (e.g. meat, sauce, grain, cheese, vegetables); the components are included in other food categories. Prepared foods require minimal preparation by the consumer (e.g. heating, thawing, rehydrating) e.g. pav-bhaji, ready to eat dishes, biryani, curried rice, sandwiches (filling with egg/chicken/vegetarian sandwiches, etc.), burgers, fish burgers, pizza, etc. Provisions for additives will be listed in this food category in these regulations only if the additive is needed: (i) solely to have a technological function in the prepared food as sold to the consumer; or (ii) at a use level that has an intentional technological function in the prepared food that exceeds the use level that can be accounted for by carry over from the individual components.” 48. Going by the definition in clause (j) of Section 3(1) of the Act, ‘food’ means any substance, whether processed, partially processed or unprocessed, which is intended for human consumption and includes primary food to the extent defined in clause (zk), genetically modified or engineered food or food containing such ingredients, infant food, packaged drinking water, alcoholic drink, chewing gum, and any substance, including water used into the food during its manufacture, preparation or treatment. Clause (n) of Section 3(1) of the Act defines ‘food business’ to mean any undertaking, whether for profit or not and whether public or private, carrying out any of the activities related to any stage of manufacture, processing, packaging, storage, transportation, distribution of food, import and includes food services, catering services, sale of food or food ingredients. Clause (o) of Section 3(1) defines ‘food business operator’ in relation to food business to mean a person by whom the business is carried on or owned and is responsible for ensuring the compliance of this Act, rules and regulations made thereunder. A plain reading of the provisions referred to above would make it explicitly clear that Aravana and cardamom falls within the sweep of ‘food’ defined in clause (j) of Section 3(1) of the Act. The wider definition of ‘food business’ in clause (n) of Section 3(1) of the Act takes within its sweep any of the activities related to any stage of manufacture, processing, packaging, storage, transportation, distribution of food or import carried out by an undertaking, whether for profit or not and whether public or private, including food services, catering services, sale of food or food ingredients. A plain reading of clause (n) of Section 3(1) of the Act would make it explicitly clear the activities of the Travancore Devaswom Board related to the manufacture, processing, packaging, etc., of Aravana fall within the definition of ‘food business’. Therefore, the Travancore Devaswom Board falls within the sweep of ‘food business operator’ defined in clause (o) of Section 3(1) of the Act, in relation to the said food business, and the Board is responsible for ensuring the compliance of the Act, Rules and Regulations made thereunder. 49. Therefore, the Travancore Devaswom Board falls within the sweep of ‘food business operator’ defined in clause (o) of Section 3(1) of the Act, in relation to the said food business, and the Board is responsible for ensuring the compliance of the Act, Rules and Regulations made thereunder. 49. In V.G.K.Menon v. State of Kerala [ 1998 (1) KLT 981 ], a decision relied on by the learned Standing Counsel for Travancore Devaswom Board, a learned Judge of this Court was dealing with a petition filed under Section 482 of the Criminal Procedure Code, 1973 to quash the prosecution proceedings in S.T.No.175 of 1997 on the file of the Judicial First Class Magistrate Court, Ranni, which was instituted based on a complaint made by the Food Inspector, Ranni alleging an offence punishable under Section 16(1)(a) of the Prevention of Food Adulteration Act, 1954, against the President and Members of the Travancore Devaswom Board. On 08.01.1997, the Food Inspector inspected four tanks in Sabarimala in which ghee is stored for preparation of Appam and Aravana. He obtained 450 ml. of ghee from the Store Superintendent of Sabarimala Devaswom, on payment of Rs.45/-as its cost. He divided the ghee into three portions, packed and sealed it as per Rules and sent one sample to the Public Analyst. On receipt of a report that the sample does not conform to the standards prescribed for ghee under the Prevention of Food Adulteration Rules, complaint was filed before the Magistrate Court, impleading the Store Superintendent as the 1st accused, the Executive Officer of the Devaswom as the 2nd accused and the President and two Members of the Travancore Devaswom Board as accused Nos.3 to 5 and the Devaswom Board itself as the 6th accused. After referring to the provisions under clause (xiii) of Section 2 of the said Act, which define ‘sale’, and the provisions under Section 16(1)(a), the learned Single Judge held that storing of an adulterated article of food for purposes other than for sale would not constitute an offence under Section 16(1)(a). The Food Inspector can take samples only if the article is kept for sale. The ghee purchased by the Food Inspector was not for sale nor for preparation of an article of food intended for sale. The Food Inspector can take samples only if the article is kept for sale. The ghee purchased by the Food Inspector was not for sale nor for preparation of an article of food intended for sale. Therefore, the learned Single Judge held that the Food Inspector has no authority to collect a sample and for that reason the supply of sample of ghee and payment of its cost cannot amount to sale for the purpose of the said Act. 50. We are in disagreement with the proposition laid down by the learned Single Judge in V.G.K.Menon [ 1998 (1) KLT 981 ] that an offence under Section 16(1)(a) of the Prevention of Food Adulteration Act is not attracted, since Appam and Aravana prepared by the Travancore Devaswom Board is not an article of food intended for sale and that, Appam and Aravana are distributed from Sabarimala as prasadam and therefore, what is paid by the devotees is only their offering. In Sabarimala, Appam and Aravana Prasadam are sold to devotees on payment of the price fixed by the Travancore Devaswom Board, from time to time. As already noticed, the wider definition of ‘food business’ in clause (n) of Section 3(1) of the Act takes within its sweep any of the activities related to any stage of manufacture, processing, packaging, storage, transportation, distribution of food or import carried out by an undertaking, whether for profit or not and whether public or private, including food services, catering services, sale of food or food ingredients. A plain reading of the provisions under clause (j) of Section 3(1) of the Food Safety Standards Act, which defines the term ‘food’, clause (n) of Section 3(1) of the Act, which defines the term ‘food business’, and clause (zr) of Section 3(1) of the Act, which defines the term ‘sale’ would lead to an irresistible conclusion that the manufacturing, processing, packaging, storing and sale of Appam and Aravana Prasadam at Sabarimala by the Travancore Devaswom Board will fall within the sweep of ‘food business’ as defined in clause (n) of Section 3(1) of the Act and ‘sale’ as defined in clause (zr) of Section 3(1) of the Act. 51. Clause (q) of Section 3(1) of the Act defines ‘food safety’ to mean an assurance that food is acceptable for human consumption according to its intended use. 51. Clause (q) of Section 3(1) of the Act defines ‘food safety’ to mean an assurance that food is acceptable for human consumption according to its intended use. The wider definition of ‘ingredient’ in clause (y) of Section 3(1) of the Act takes within its sweep, any substance, including a food additive used in the manufacture or preparation of food and present in the final product, possibly in a modified form. The term ‘manufacture’ defined in clause (zc) of Section 3(1) of the Act takes within its sweep a process or adoption or any treatment for conversion of ingredients into an article of food, which includes any sub-process, incidental or ancillary to the manufacture of an article of food. The wider definition of the term ‘manufacturer’ in clause (zd) of Section 3(1) of the Act takes within its sweep not only a person engaged in the business of manufacturing any article of food for sale but also any person who obtains such article from another person and packs and labels it for sale or only labels it for such purposes. 52. Clause (zz) of Section 3(1) of the Act defines the term ‘unsafe food’ to mean an article of food whose name, substance or quality is so affected in any one of the manners enumerated in clauses (i) to (xii) as to render it injurious to health. Clause (iii) of clause (zz) of Section 3(1) deals with an article of food whose name, substance or quality is so affected by virtue of its unhygienic processing or the presence in that article of any harmful substance as to render it injurious to health. Clause (xii) of clause (zz) of Section 3(1) deals with an article of food whose name, substance or quality is so affected by virtue of containing pesticides and other contaminants in excess of quantities specified by regulations as to render it injurious to health. 53. In exercise of the powers conferred by clause (o) of sub-section (2) of Section 92 read with Section 31 of Food Safety and Standards Act, 2006 the Food Safety and Standards Authority of India made Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011. Regulation 2.1. deals with registration and licensing of food business. 53. In exercise of the powers conferred by clause (o) of sub-section (2) of Section 92 read with Section 31 of Food Safety and Standards Act, 2006 the Food Safety and Standards Authority of India made Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011. Regulation 2.1. deals with registration and licensing of food business. In view of the statutory mandate of Regulation 2.1., all food business operators in the country will be registered or licensed in accordance with the procedures laid down in the said Regulations. Regulation 2.1.1. provides registration even for petty food business. Regulation 2.1.2. deals with licence for food business. As per Regulation 2.1.2., subject to Regulation 2.1.1, no person shall commence any food business unless he possesses a valid licence. As per clause (5) of Regulation 2.1.2., the food business operator shall ensure that all conditions of licence as provided in Annexure 3 of Form B in Schedule 2 and safety, sanitary and hygienic requirements provided in the Schedule 4 contained under different Parts depending on nature of business are complied with at all times. As per the first proviso to clause (5), the Licensing Authority shall ensure periodical food safety audit and inspection of the licensed establishments through its own or agencies authorised for this purpose by the Food Safety Standards Authority of India. Annexure 3 of the Regulations deals with conditions of licence. As per condition No.9, all food business operators shall ensure that the source and standards of raw material used are of optimum quality at all times during the course of its food business. 54. In the instant case, initially, pursuant to the order of this Court dated 23.12.2022 in W.P.(C)No.41743 of 2022, the sample of cardamom supplied by the 2nd respondent herein was sent for testing to the Government Analyst’s Laboratory, Thiruvananthapuram. The certificate of the examination dated 28.12.2022 issued by the Food Analyst in the Government Analyst’s Laboratory contains the opinion of the Food Analyst, which reads thus; “Opinion: The said sample contains the insecticide residues Fipronil, Tebuconazole and Imidacloprid to an extent of not less than 0.061 mg/kg, 0.792 mg/kg and 0.795 mg/kg respectively which exceeds the MRL (Maximum Residue Limit) as per Regulation 2.3.1. of Food Safety and Standards (Contaminants, Toxins and Residues) Regulations 2011, read with Note:-[Tolerance limit of 0.01 mg/kg shall apply in cases of Pesticides for which MRL have not been fixed & File No. Std/SP-02/Technical Matter/2021-22[E-4311] of FSSAI dated 21st April 2022] and is therefore unsafe as per Section 3(1)(zz)(iii)&(xii) of Food Safety and Standards Act 2006.” 55. Thereafter, in terms of the order dated 06.01.2023 in W.P.(C)No.41743 of 2022, another sample of cardamom supplied by the contractor, the 2nd respondent herein, was sent for testing to the accredited laboratory of the Food Safety and Standards Authority of India. Since facilities are not available in the primary accredited laboratory at Kochi, the sample was sent to a referral laboratory, i.e., Quality Evaluation Laboratory of the Spices Board at Kochi. In terms of the orders of this Court, the test report was forwarded to the Executive Director of the Food Safety and Standards Authority of India. On 11.01.2023, when W.P.(C)No.41743 of 2022 came up for consideration, the learned Central Government Counsel has placed on record, along with a memo dated 11.01.2023, the test report dated 10.01.2023 issued by the Quality Evaluation Laboratory of the Spices Board at Kochi and also the report dated 11.01.2023 of the Executive Director, Food Safety and Standards Authority of India. The report of the Executive Director of the Food Safety and Standards Authority of India is reproduced hereunder; “In pursuance to the order dated 06.01.2023 of the Honb'le High Court of Kerala, the opinion by Advisor (QA), is as given as below: The report of Quality Evaluation Laboratory (QEL), Spices Board, Kochi has been scrutinized and the following is observed: Total 95 pesticides, were tested in which 14 pesticides are found to be exceeding the MRL (Minimum Residual Limit) as specified under Food Safety and Standards (Contaminants, Toxins and Residues) Regulation, 2011. In addition, it may be noted that as per FSS (Contaminants, Toxins and Residues) Regulation, 2011, MRL/limit of six pesticides (Copper sulphate, copper oxychloride, Diafenthiuron, FosetylAl, Monocrotophos and Quinalphos) specially for cardamom is defined. Out of above, two (Monocrotophos and Quinalphos) were tested by QEL, Kochi in which the sample is exceeding the limit for Quinalphos. Tolerance limit of 0.01 mg/kg shall apply in cases of pesticides for which MRL have not been fixed. Out of above, two (Monocrotophos and Quinalphos) were tested by QEL, Kochi in which the sample is exceeding the limit for Quinalphos. Tolerance limit of 0.01 mg/kg shall apply in cases of pesticides for which MRL have not been fixed. The details of 14 pesticides which are exceeding the MRL as follows: Sl.No. Pesticide Test result(mg/kg) Maximum Residue Limit (MRL) in mg/kg as per FSSR 1 Carbendazim 0.17 0.01 2 Chlorpyrifos 0.41 0.01 3 Cyfluthrin (isomers) 0.73 0.01 4 Cyhalothrin lambda 0.14 0.01 5 Cyhalothrin gamma 0.16 0.01 6 Cypermethrin (isomers) 1.10 0.01 7 Diothiocarbamates (Total) 14.04 0.01 8 Hexaconazole 0.09 0.01 9 Imidacloprid 1.09 0.01 10 Metalaxyl 0.04 0.01 11 Quinalphos 0.75 0.01 12 Tebuconazole 0.18 0.01 13 Fipronil 0.06 0.01 14 Thiamethoxam 0.30 0.01 In view of the above, the sample is not conforming to regulation 2.3.1 of FSS (Contaminants, Toxins and Residues) Regulation, 2011 and amendments thereon. Therefore the sample is unsafe as per section 3(1)(zz)(xii) of the Food Safety and Standards Act, 2006. (underline supplied) 56. In the report dated 11.01.2023 of the Executive Director, Food Safety and Standards Authority of India, it has been categorically stated that the sample of cardamom taken from the cardamom supplied by the 2nd respondent herein-contractor is not conforming to Regulation 2.3.1. of the Food Safety Standards(Contaminants, Toxins and Residues) Regulations, 2011 and the amendments thereon, which is unsafe as per Section 3(1)(zz)(xii) of the Food Safety and Standards Act, 2006. When the contract between the Travancore Devaswom Board and the 2nd respondent herein-contractor is for the supply of 15,000 kg cardamom, in terms of the tender conditions and also the statutory mandate of the Regulations made under the Food Safety and Standards Act, 2006, the cardamom supplied by the contractor has to meet the requirements of the relevant Regulations. If the cardamom supplied by the 2nd respondent herein-contractor does not meet the Maximum Residue Limits (MRLs) prescribed under the Regulations, it is unsafe as per Section 3(1)(zz)(xii) of the Food Safety and Standards Act, 2006, as found in the report dated 10.01.2023 of the Executive Director, Food Safety and Standards Authority of India. 57. If the cardamom supplied by the 2nd respondent herein-contractor does not meet the Maximum Residue Limits (MRLs) prescribed under the Regulations, it is unsafe as per Section 3(1)(zz)(xii) of the Food Safety and Standards Act, 2006, as found in the report dated 10.01.2023 of the Executive Director, Food Safety and Standards Authority of India. 57. As per sub-section (1) of Section 26, every food business operator shall ensure that the articles of food satisfy the requirements of the Act and the Rules and Regulations made thereunder at all stages of production, processing, import, distribution and sale within the businesses under his control. In view of the provisions under Section 26 of the Act, the Travancore Devaswom Board, which falls within the sweep of ‘food business operator’ as defined in clause (o) of Section 3(1) of the Act, in relation to the manufacture, processing, packing, etc., of Aravana, which falls within the sweep of ‘food business’ as defined in clause (n) of Section 3(1) of the Act, has to ensure that Aravana satisfy the requirements of the Act and the Rules and Regulations made thereunder at all stages of production, processing, import, distribution and sale, etc. Therefore, the Travancore Devaswom Board has to ensure that cardamon and other ingredients used for Aravana satisfy the requirements of the Act and the Rules and Regulations made thereunder. The statutory mandate of clause (i) of sub-section (2) of Section 26 is that no food business operator shall himself or by any person on his behalf manufacture, store, sell or distribute any article of food which is unsafe. In view of the provisions under sub-clause (xii) of clause (zz) of Section 3(1) of the Act, ‘unsafe food’ means an article of food whose name, substance or quality is so affected as to render it injurious to health by virtue of containing pesticides and other contaminants in excess of quantities specified by regulations. Therefore, once it is found that the sample of cardamom is not conforming to Regulation 2.3.1. Therefore, once it is found that the sample of cardamom is not conforming to Regulation 2.3.1. of the Food Safety Standards (Contaminants, Toxins and Residues) Regulation, 2011 and amendments thereon and as such it is unsafe as per the provisions in sub-clause (xii) of clause (zz) of Section 3(1) of the Act, the Travancore Devaswom Board cannot store, sell or distribute Aravana made using that cardamom, since the said article of food falls within the sweep of ‘unsafe food’, as defined in the said sub-clause. 58. The learned Standing Counsel for Travancore Devaswom Board and also the learned counsel for the 2nd respondent herein-contractor would contend that the Maximum Residue Limits (MRLs) of a pesticide for a food commodity is fixed taking into consideration overall dietary intake of pesticide through consumption of different food commodities to ensure safety of food products. There is no uniform fixation of MRLs. The Consortium of Curry Powder Manufacturers of Kerala submitted various representations before the Food Safety Standards Authority of India pointing out the difficulty in complying with the default MRLs (0.01 mg/kg) of pesticides and requesting to review the existing default MRLs in spices. The Joint Director (Science and Standards), Food Safety Standards Authority of India, in continuation of letter vide File No.Std/SP-02/T-1 dated 10.06.2020, informed the Food Safety Commissioner, Kerala, vide Ext.R5(i) letter vide File No.Std/SP-02/T-1 dated 04.09.2020 that the matter has been referred to the Scientific Panel on Pesticide Residues for detailed risk analysis and fixation of MRLs of pesticides in spices on the basis of the data provided by All India Network Project on Pesticide Residues, Indian Council of Agricultural Research (ICAR). Since the Scientific Panel in its 61st meeting has taken up the issue and the fixation of MRLs of pesticides in spices has been initiated, the Food Safety Commissioner, Kerala was advised to wait on the proceedings till the finalization of MRLs. Based on Ext.R5(i) letter, the Consortium of Curry Powder Manufacturers of Kerala submitted Ext.R5(j) representation dated 15.09.2020 before the Food Safety Commissioner, Kerala and also the Designated Officers, with a request to defer all proceedings, including prosecution proceedings, till the finalization of MRLs. A copy of letter vide File No.Std/SP-02/T-1 dated 04.09.2020 of the Joint Director (Science and Standards), Food Safety Standards Authority of India is marked as Ext.R1(i) in the counter affidavit filed by the Travancore Devaswom Board. A copy of letter vide File No.Std/SP-02/T-1 dated 04.09.2020 of the Joint Director (Science and Standards), Food Safety Standards Authority of India is marked as Ext.R1(i) in the counter affidavit filed by the Travancore Devaswom Board. The learned Standing Counsel for Travancore Devaswom Board and also the learned counsel for the 2nd respondent herein-contractor would contend that, when detailed risk analysis for fixation of MRLs of pesticides in spices by the Scientific Panel constituted by the Food Safety Standards Authority of India, by virtue of the provisions under Section 13 of the Act, is still going on the Food Safety Commissioner, Kerala and also the Designated Officers are bound by the advisory issued by the Joint Director (Science and Standards), Food Safety Standards Authority of India vide Ext.R1(i)/R5(i) letter dated 04.09.2020, which is having statutory force in view of the provisions under sub-section (5) of Section 16 of the Act. As of now the default MRLs (0.01 mg/kg) has been kept in abeyance particularly in respect of spices. The Executive Director (Compliance Strategy), Food Safety Standards Authority of India, vide Ext.R1(g) letter dated 11.01.2021 clarified, with reference to the Note to Regulation 2.3.1., that the MRLs of 213 pesticides given in the table and tolerance limit of 0.01mg/kg specified in the Note pertain to agricultural commodities and the resultant physically processed foods only. The said MRLs and tolerance limits do not apply to the thermally and chemically processed foods. Vide Ext.R1(h) order dated 21.04.2022 of the Advisor (Science and Standards), Food Safety Standards Authority of India, vide Ext.R1(h) order dated 21.04.2022 it was decided that in case of spices and culinary herbs the MRLs specified by Codex would be adopted till such time MRLs are specified for those commodities based on filed trial data. In the absence of Codex MRLs, the MRLs specified by the regulatory authorities of the exporting countries shall be considered for compliance. Therefore, the test reports, i.e., certificate of examination dated 28.12.2022 issued by the Food Analyst, Government Analyst’s Laboratory, Thiruvananthapuram and the test report dated 10.01.2023 issued by the Quality Evaluation Laboratory of the Spices Board at Kochi, which are issued contrary to the advisory in Ext.R1(i)/R5(i) letter dated 04.09.2020, have no legs to stand. Therefore, the test reports, i.e., certificate of examination dated 28.12.2022 issued by the Food Analyst, Government Analyst’s Laboratory, Thiruvananthapuram and the test report dated 10.01.2023 issued by the Quality Evaluation Laboratory of the Spices Board at Kochi, which are issued contrary to the advisory in Ext.R1(i)/R5(i) letter dated 04.09.2020, have no legs to stand. That being so, the prohibition on the sale of Aravana based on those test reports, on the suspicion of being unsafe, is legally impermissible, and Aravana may be subjected to chemical analysis to ascertain whether it is fit for human consumption. 59. Along with the memo filed by the learned Central Government Counsel, letter vide File No.Std/SP-02/Technical Matter/2021-22[E-4311] dated 30.08.2022 issued by the Joint Director (Science and Standards), Food Safety and Standard Authority of India to the Commissioner of Food Safety, Kerala; order vide File No. Std/SP-02/Technical Matter/2021-22[E-4311] dated 30.08.2022 issued by the Advisor (Science and Standards), Food Safety and Standard Authority of India; and order vide File No.Std/SP-02/TechnicalMatter/2021-22[E-4311]dated 21.04.2022 issued by the Advisor (Science and Standards), Food Safety and Standard Authority of India are placed on record. 60. Order vide File No. Std/SP-02/Technical Matter/2021-22[E-4311] dated 21.04.2022 issued by the Advisor (Science and Standards), Food Safety and Standard Authority of India reads thus; “Subject: Maximum Residue Limits (MRLs) for Spices and Culinary Herbs- reg. Food Safety and Standards Authority of India fixes the MRLs of pesticides on different food commodities based on the field trial data submitted by pesticide manufacturers received through Central Insecticides Board and Registration Committee (CIB & RC), Directorate of Plant Protection Quarantine & Storage, Ministry of Agriculture and Farmers Welfare. These MRLs are notified under Food Safety and Standards (Contaminants, Toxins and Residues) Regulation, 2011. 2. In India, in case of Spices and Culinary Herbs, MRLs are not specified for most of the pesticides due to lack of filed trial data. However, globally many regulators have specified MRLs of pesticides for these food commodities. 3. Considering the importance of the issue and based on the Scientific Opinion, it has been decided that in case of spices and culinary herbs the MRLs specified by Codex would be adopted till such time MRLs are specified for these commodities based on the field trial data. Further, in the absence of Codex MRLs, MRLs specified by the regulatory authorities of the exporting countries shall be considered for compliance. 4. Further, in the absence of Codex MRLs, MRLs specified by the regulatory authorities of the exporting countries shall be considered for compliance. 4. This issues with the approval of Competent Authority.” 61. Order vide File No. Std/SP-02/Technical Matter/2021-22[E-4311] dated 30.08.2022 issued by the Joint Director (Science and Standards), Food Safety and Standard Authority of India reads thus; “Subject: Maximum Residue Limits (MRLs) for Spices and Culinary Herbs- reg. This is in continuation of the order dated 24th April, 2022 (Annexed) related to subject above. 2. In India, in case of Spices and Culinary Herbs, MRLs are not specified for most of the pesticides due to lack of filed trial data as endorsed by CIB & RC. 3. Considering the importance of the issue, the principle mentioned in the order 24th April, 2022 for specifying the MRL of pesticides is hereby extended to domestically produced Spices and Culinary Herbs with the following modifications- i. In case of pesticides registered with CIB & RC (and MRLs fixed by FSSAI) for other commodities and MRLs are specified by Codex/EU/USA/Japan/FSANZ for any of these registered pesticides in case of spices and culinary herbs, the MRL fixed by Codex/EU/USA/Japan/FSANZ will apply. ii. In case of those pesticides not registered with CIB & RC, even if MRLs are fixed for specific spice or culinary herbs as per Codex/EU/USA/Japan/FSANZ, the default MRL of 0.01 mg per Kg [or Below Detection Limit (BDL)] shall apply. 4. This issues with the approval of Competent Authority.” 62. Letter vide File No. Std/SP-02/Technical Matter/2021-22[E-4311] dated 30.08.2022 issued by the Joint Director (Science and Standards), Food Safety and Standard Authority of India to the Commissioner of Food Safety, Kerala, reads thus; “Subject: Fixation of Maximum Residue Limits (MRLs) of pesticide in spices-reg. Ref:- Letter No. Std/SP-02/T-1 dated 4th September, 2020. Sir, This is in continuation of the letter dated 4th September, 2020 regarding the review of the fixation MRLs on spices. 2. Please find the enclosed order issued by FSSAI for your reference and necessary action. In view of this, the letter dated 4th September, 2020 issued by this Division will not be valid anymore. 3. This issues with the approval of Competent Authority.”(underline supplied) 63. 2. Please find the enclosed order issued by FSSAI for your reference and necessary action. In view of this, the letter dated 4th September, 2020 issued by this Division will not be valid anymore. 3. This issues with the approval of Competent Authority.”(underline supplied) 63. We find that the arguments advanced by the learned Standing Counsel for Travancore Devaswom Board and the 2nd respondent herein-contractor, relying on Ext.R1(i)/R5(i) letter dated 04.09.2020 of the Joint Director (Science and Standards), Food Safety and Standards Authority of India, is absolutely untenable, since the said letter has already been withdrawn, as evidenced by the letter vide File No. Std/SP-02/Technical Matter/2021-22[E-4311] dated 30.08.2022 issued by the Joint Director (Science and Standards). 64. Insofar as the arguments advanced by the learned counsel for the 2nd respondent herein-contractor relying on Regulation 2.12 of the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, which deals with proprietary food, we notice that, as per clause (1) of Regulation 2.12, proprietary food means an article of food that has not been standardised under these regulations, but does not include novel foods, foods for special dietary uses, foods for special medical purposes, functional foods, neutraceuticals, health supplements and such other food articles which the Central Government may notify in this behalf. As per the proviso to clause (1), any deviation in quality parameters of a standardised food, as specified in the Food Safety and Standards Regulations made under the Food Safety and Standards Act shall not qualify the resultant product as a proprietary food. In view of the provisions under clause (2) of Regulation 2.12, proprietary food shall contain only those ingredients other than additives which are either standardised or permitted for use in the preparation of food products under the Food Safety Standards and Regulations and those food or ingredients mentioned in the Indian Food Composition Tables (IFCT), 2017, National Institute of Nutrition, except the ingredients which may be specified by the Authority from time to time and those specified under prohibition of hunting in the Indian Wildlife Protection Act, 1972. Insofar as the arguments advanced by the learned counsel for the 2nd respondent herein-contractor relying on category 16.0 in Appendix A of the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, we notice that, prepared foods under Category 16.0 in Appendix A are mixtures of multiple components (e.g. meat, sauce, grain, cheese, vegetables); the components are included in other food categories. Prepared foods require minimal preparation by the consumer (e.g. heating, thawing, rehydrating) e.g. pav-bhaji, ready to eat dishes, biryani, curried rice, sandwiches (filling with egg/chicken/vegetarian sandwiches, etc.), burgers, fish burgers, pizza, etc. Therefore, we find absolutely no merits in the arguments advanced by the learned counsel for the 2nd respondent herein-contractor relying on clause (1) of Regulation 2.12 and category 16.0 in Appendix A of the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. 65. As already noticed, in view of the provisions under Section 26 of the Act, the Travancore Devaswom Board, which falls within the sweep of ‘food business operator’ as defined in clause (o) of Section 3(1) of the Act, in relation to the manufacture, processing, packing, etc., of Aravana, which falls within the sweep of ‘food business’ as defined in clause (n) of Section 3(1) of the Act, has to ensure that Aravana satisfy the requirements of the Act and the Rules and Regulations made thereunder at all stages of production, processing, import, distribution and sale, etc. Therefore, once it is found that the sample of cardamom is not conforming to Regulation 2.3.1. of the Food Safety Standards (Contaminants, Toxins and Residues) Regulation, 2011 and amendments thereon and as such it is unsafe as per the provisions in sub-clause (xii) of clause (zz) of Section 3(1) of the Act, the Travancore Devaswom Board cannot store, sell or distribute Aravana made using that cardamom, since the said article of food falls within the sweep of ‘unsafe food’, as defined in the said sub-clause. Therefore, no purpose will be served by sending Aravana made using that cardamom for analysis at any laboratory accredited by the Food Safety and Standards Authority of India. 66. In the result, the applicants/respondents 1 to 4 in the writ petition are not entitled to the relief sought for in this interlocutory application and the same is accordingly, dismissed. Therefore, no purpose will be served by sending Aravana made using that cardamom for analysis at any laboratory accredited by the Food Safety and Standards Authority of India. 66. In the result, the applicants/respondents 1 to 4 in the writ petition are not entitled to the relief sought for in this interlocutory application and the same is accordingly, dismissed. The learned Senior Government Pleader to get instructions from the additional 7th respondent Commissioner of Food Safety, Kerala on the disposal of a total stock of 6,65,159 cans of Aravana, which is kept in a sealed godown after preparing a mahazar on 11.01.2023. List on 03.04.2023. ORDER : Anil K. Narendran, J. I.A.No.3 of 2023 This interlocutory application is one filed by Travancore Devaswom Board and its officials, respondents 1 to 4 in W.P.(C)No.41743 of 2022, seeking permission to draw samples from the stock of Aravana Prasadam kept sealed pursuant to the orders of this Court dated 11.01.2023, through the Food Safety Officers and send the same to analysis to any laboratory accredited by the Food Safety Authority of India to test whether Aravana Prasadam conforms to the food standards prescribed by the Food Safety and Standards Authority of India and safe for human consumption. 2. Along with the memo dated 07.02.2023 of the learned Central Government Counsel, report No.P.15017/15/2023-FSSAI/Legal dated 10.02.2023 of the Deputy Director, Food Safety Standards Authority of India, in response to I.A.No.3 of 2023 is placed on record, wherein it is stated that as per sub-section (2) of Section 26 of the Act the onus is on the food business operators, who have to comply with the provisions of the Act, Rules and Regulations. According to the conditions of licence at Annexure 3 of Food Safety and Standards (Licensing and Registration of Food Business) Regulations, 2011 raw material used by food business operators shall be of optimum quality. Therefore, any raw material used in the preparation of food shall comply with all the standards specified under the Food Safety Standard Regulations. Further as per Section 3(zz)(i) if the food article is composed of unsafe ingredients whether wholly or in part, the article of food is considered unsafe food. In the instant case, Cardamom used as a raw material of the end product, i.e., Aravana shall be of optimum quality. Further as per Section 3(zz)(i) if the food article is composed of unsafe ingredients whether wholly or in part, the article of food is considered unsafe food. In the instant case, Cardamom used as a raw material of the end product, i.e., Aravana shall be of optimum quality. The Cardamom used for the preparation of Aravana has been declared unsafe vide Report dated 11.01.2023 due to the presence of pesticides which exceeds the Maximum Residue Limits (MRL) prescribed by the Food Safety and Standards Authority of India. MRLs of a pesticide for a food commodity, irrespective of the fact that it may be directly consumed or used as an ingredient in another food, is fixed while taking into consideration the overall dietary intake of pesticides through consumption of different food commodities to ensure the safety of food products. Therefore, unsafe raw materials shall not be used in the preparation of any article of food. 3. After the filing of this interlocutory application, the 2nd respondent herein, who is the 5th respondent-contractor in W.P.(C)No.41743 of 2022, filed a counter affidavit dated 14.02.2023 in the writ petition. The applicants/additional respondents 1 to 4 have filed an additional counter affidavit dated 15.02.2023 in the writ petition. 4. Heard the learned Standing Counsel for Travancore Devaswom Board for the applicants-respondents 1 to 4, the learned counsel for the 1st respondent-writ petitioner, the learned counsel for the 2nd respondent-contractor, the learned Senior Government Pleader for the State and its officials and the learned Central Government Counsel for the Central Government and Food Safety and Standards Authority of India. 5. The 1st respondent herein, who was the supplier of cardamom to the Travancore Devaswom Board, during the Mandala-Makaravilakku festival season of 1197 ME (2021-22), has filed W.P.(C)No.41743 of 2022, invoking the writ jurisdiction under Article 226 of the Constitution of India, seeking a writ of mandamus commanding the Travancore Devaswom Board to conduct an analysis of the cardamom, which was purchased after the cancellation of the tender conducted pursuant to Ext.P9 e-tender notification dated 12.10.2022, during Mandala-Makaravilakku festival season of 1198 ME (2022-23), at Government Analytical Laboratory, Thiruvananthapuram, under the supervision of this Court. The petitioner has also sought for a writ of certiorari to quash the proceedings of the Travancore Devaswom Board for local purchase of cardamom, at Sabarimala Devaswom, during Mandala-Makaravilakku festival season of 1198 ME (2022-23), as it was done without competition and newspaper advertisement. 6. The 2nd respondent herein, who is the 5th respondent in the writ petition, is supplying cardamom at Sabarimala, during Mandala-Makaravilakku festival season of 1198 ME (2022-23), pursuant to Ext.R1(A) notification dated 04.11.2022 issued by the Executive Officer, Sabarimala Devaswom, inviting quotations along with samples for supply of 15,000 kg. of cardamom at Sabarimala during Mandala-Makaravilakku festival season of 1198 ME (2022-23). The said notification is one issued after three successive e-tender notifications, i.e., Exts.P3, P6 and P9 notifications, for the supply of cardamom at Sabarimala, for the period from 01.11.2022 to 30.09.2023. 7. On 21.12.2022, when W.P.(C)No.41743 of 2022 came up for admission, the learned Standing Counsel for Travancore Devaswom Board took notice on admission for respondents 1 to 4. Urgent notice by special messenger was ordered to the 5th respondent-contractor, the 2nd respondent in this interlocutory application, returnable by 23.12.2022. In W.P.(C)No. 41743 of 2022, this Court passed an order dated 23.12.2022, whereby the sample of cardamom supplied by the contractor was sent to the Government Analyst’s Laboratory, Thiruvananthapuram, for testing. As per the opinion of the Food Analyst in the certificate of the examination dated 28.12.2022, the sample contains the insecticide residues Fipronil, Tebuconazole and Imidacloprid to an extent of not less than 0.061 mg/kg, 0.792 mg/kg and 0.795 mg/kg respectively, which exceeds the MRL (Maximum Residue Limit) as per Regulation 2.3.1 of Food Safety and Standards (Contaminants Toxins and Residues) Regulations 2011, read with Note [Std/SP-02/Technical Matter/ 2021-22[E-4311] of FSSAI dated 21st April 2022] and is therefore unsafe as per Section 3(1)(zz)(iii)&(xii) of Food Safety and Standards Act 2006. 8. In the order dated 05.01.2023 in W.P.(C)No.41743 of 2022, this Court noticed that the opinion of the Food Analyst in Ext.R1(g) certificate of examination is with reference to Std/SP-02/Technical Matter/2021-22 [E-4311] of FSSAI dated 21.04.2022 of the Advisor (Science and Standards), Food Safety and Standards Authority of India, which deals with maximum residue limits for Spices and Culinary Herbs. 8. In the order dated 05.01.2023 in W.P.(C)No.41743 of 2022, this Court noticed that the opinion of the Food Analyst in Ext.R1(g) certificate of examination is with reference to Std/SP-02/Technical Matter/2021-22 [E-4311] of FSSAI dated 21.04.2022 of the Advisor (Science and Standards), Food Safety and Standards Authority of India, which deals with maximum residue limits for Spices and Culinary Herbs. The Executive Director (Compliance Strategy) of Food Safety and Standards Authority of India has issued a clarification dated 11.01.2021, regarding tolerance limit in cases of insecticides for which Maximum Residue Limits (MRLs) have not been fixed. In the said clarification, which is one issued with the approval of the Competent Authority, it is clarified that MRLs of 213 insecticides given in the Table and Tolerance Limit of 0.01 mg/kg mentioned in the Note pertain to agricultural commodities and the resultant physically processed foods only. The said MRLs and tolerance limit do not apply to the thermally and chemically processed foods. On 05.01.2023, the learned Central Government Counsel sought time to get instructions from the Food Safety and Standards Authority of India on Ext.R1(f) certificate of examination dated 28.12.2022, with specific reference to the clarification dated 11.01.2021. 9. By the order dated 06.01.2023 in W.P.(C)No.41743 of 2022, this Court directed the Food Safety Officer at Sannidhanam, under the Commissioner of Food Safety, Kerala, the 4th respondent herein, to collect samples of cardamom supplied by the contractor, the 2nd respondent herein, on 07.01.2023, in the presence of the Executive Magistrate, the Executive Officer, Sabarimala, and also the 2nd respondent-contractor or his authorised representative, after complying with the statutory requirements. The sample so taken were directed to be sent to the accredited laboratory of the Food Safety and Standards Authority of India at Kochi, through an officer authorised by the 4th respondent Commissioner of Food Safety, which shall be subjected to analysis on 07.01.2023 itself, with reference to the provisions under the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011 and also the Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011, and the test result shall be forwarded to the 7th respondent Food Safety and Standards Authority of India, from the accredited laboratory at Kochi. On receipt of the test result, the Executive Director, the Food Safety and Standards Authority of India, shall place the same before the Advisor (Quality Assurance) and the report/opinion of the said Authority shall be made available for the perusal of this Court on 09.01.2023. 10. In terms of the order dated 06.01.2023 in W.P.(C)No.41743 of 2022, another sample of cardamom supplied by the contractor, the 2nd respondent herein, was sent for testing to the accredited laboratory of the Food Safety and Standards Authority of India. Since facilities are not available in the primary accredited laboratory at Kochi, the sample was sent to a referral laboratory, i.e., Quality Evaluation Laboratory of the Spices Board at Kochi. In terms of the orders of this Court, the test report was forwarded to the Executive Director of the Food Safety and Standards Authority of India. On 11.01.2023, when W.P.(C)No.41743 of 2022 came up for consideration, the learned Central Government Counsel has placed on record, along with a memo dated 11.01.2023, the test report dated 10.01.2023 issued by the Quality Evaluation Laboratory of the Spices Board at Kochi and also the report dated 11.01.2023 of the Executive Director, Food Safety and Standards Authority of India. In the report of the Executive Director of the Food Safety and Standards Authority of India, the opinion by Advisor (QA) is extracted, as per which, in the tests conducted in the Quality Evaluation Laboratory, Spices Board, Kochi, 14 pesticides are found to be exceeding the MRL (Minimum Residual Limit) as specified under Food Safety and Standards (Contaminants, Toxins and Residues) Regulation, 2011. In addition, as per FSS (Contaminants, Toxins and Residues) Regulation, 2011, MRL/limit of six pesticides (Copper sulphate, copper oxychloride, Diafenthiuron, Fosetyl-Al, Monocrotophos and Quinalphos) specially for cardamom is defined. Out of above, two (Monocrotophos and Quinalphos) were tested by the Quality Evaluation Laboratory, in which the sample is exceeding the limit for Quinalphos. Tolerance limit of 0.01 mg/kg shall apply in cases of pesticides for which MRL have not been fixed. In view of the above, the sample is not conforming to regulation 2.3.1 of FSS (Contaminants, Toxins and Residues) Regulation, 2011 and amendments thereon. Therefore, the sample is unsafe as per Section 3(1)(zz)(xii) of the Food Safety and Standards Act, 2006. 11. Tolerance limit of 0.01 mg/kg shall apply in cases of pesticides for which MRL have not been fixed. In view of the above, the sample is not conforming to regulation 2.3.1 of FSS (Contaminants, Toxins and Residues) Regulation, 2011 and amendments thereon. Therefore, the sample is unsafe as per Section 3(1)(zz)(xii) of the Food Safety and Standards Act, 2006. 11. The report dated 11.01.2023 of the Executive Director of the Food Safety and Standards Authority of India makes it explicitly clear that the sample of cardamom taken from the cardamom supplied by the 2nd respondent herein is not conforming to Regulation 2.3.1. of the Food Safety Standards (Contaminants, Toxins and Residues) Regulations, 2011 and the amendments thereon, which is unsafe as per Section 3(1)(zz)(xii) of the Food Safety and Standards Act, 2006. 12. On 11.01.2023, the learned Standing Counsel for Travancore Devaswom Board submitted that, in one ‘koottu’ for Aravana Prasadam, which consists of ingredients like rice, jaggery, etc., of approximately 350 kg, the quantity of cardamom is only 720 gms. Moreover, Aravana Prasadam is prepared in the plant by heating the ingredients at a temperature above 200 degrees. Since the end product, i.e., Aravana Prasadam, contains only a negligible quantity of cardamom, the fact that the cardamom supplied by the 2nd respondent herein contained pesticides exceeding the Maximum Residue Limit, will not make it unsafe for consumption, especially when it is prepared by heating the ingredients at a temperature above 200 degrees. The learned Standing Counsel submitted that Aravana Prasadam made with the cardamom supplied by the 2nd respondent herein may be ordered to be tested at the Government Analyst’s Laboratory, Thiruvananthapuram. 13. In the order dated 11.01.2023 in W.P.(C)No.41743 of 2022 this Court noticed that once the sample taken from the cardamom supplied by the 2nd respondent herein is found not conforming to Regulation 2.3.1. 13. In the order dated 11.01.2023 in W.P.(C)No.41743 of 2022 this Court noticed that once the sample taken from the cardamom supplied by the 2nd respondent herein is found not conforming to Regulation 2.3.1. of the Food Safety Standards (Contaminants, Toxins and Residues) Regulations, 2011 and the amendments thereon, which is unsafe as per Section 3(1)(zz)(xii) of the Food Safety and Standards Act, 2006, the Travancore Devaswom Board cannot be permitted to sell Aravana Prasadam made using that cardamom to the devotees, even if in one ‘koottu’ for Aravana Prasadam, which consists of ingredients like rice, jaggery, etc., of approximately 350 kg., the quantity of cardamom is only 720 gms., and Aravana Prasadam is prepared in the plant by heating the ingredients at a temperature above 200 degrees. 14. In such circumstances, by the interim order dated 11.01.2023 in W.P.(C)No.41743 of 2022, this Court restrained the Travancore Devaswom Board from selling Aravana Prasadam made using the cardamom supplied by the 2nd respondent herein, to the pilgrims. This Court directed the Commissioner of Food Safety, the 4th respondent herein, through the Food Safety Officer at Sannidhanam, to take necessary steps to ensure that Aravana Prasadam made using the cardamom supplied by the 1st respondent contractor is not sold to the pilgrims. Necessary steps in that regard were directed to be taken forthwith, without awaiting receipt of a copy of the order dated 11.01.2023. The learned Senior Government Pleader and the learned Standing Counsel for Travancore Devaswom Board were directed to communicate telephonically the directions contained in the order dated 11.01.2023 to the officers concerned forthwith. It was made clear that the order dated 11.01.2023 will not stand in the way of the Travancore Devaswom Board in making Aravana Prasadam without cardamom or after procuring cardamom, which meets the standards prescribed in the Regulations framed under the Food Safety and Standards Act, 2006, after obtaining test report from the Government Analyst’s Laboratory, Thiruvananthapuram. 15. On 13.01.2023, when W.P.(C)No.41743 of 2022 came up for consideration, the Commissioner of Food Safety, Kerala filed a compliance report, wherein it is stated that the Food Safety Squad inspected the Aravana Prasadam distribution counters situated near Aazhi and Malikappuram on 11.01.2023 and directed the Executive Officer, Sabarimala Devaswom, to stop the sale of the existing stock of Aravana Prasadam and accordingly the Devaswom Board authorities stopped the sale of Aravana Prasadam. The Food Safety Squad conducted a detailed inspection of the counters near Aazhi, Malikappuram and the godown situated at Malikappuram, old Annadana Mandapam. Based on the statement received from the Devaswom Authorities, a total stock of 6,65,159 cans bearing batch Nos.62 to 69 were found in various counters and adjacent godowns. Along with this, a stock of 800 gms. cardamom and a stock of 43.920 kg. cardamom powder were found in the Devaswom main stall. A spot mahazar was prepared and the godown was sealed and locked in the presence of witnesses and the key was handed over to the Executive Officer with a direction, entrusting him the sole responsibility of safe custody of 6,65,159 cans of Aravana Prasadam, 800 gms. of cardamom and 43.920 kg. of cardamom powder. Production of a fresh batch of Aravana Prasadam, (batch no.70) started at the Aravana Prasadam preparation plant without using cardamom, under the supervision of the Food Safety Special Squad. At 3.30 a.m, on 12.01.2023, and sale of Aravana Prasadam with batch No.70 was resumed at the prasadam counter situated near Aazhi. All procedures ended at 4.00 p.m. on 12.01.2023. 16. On 13.01.2023, when W.P.(C)No.41743 of 2022 came up for consideration, compliance report filed by the Commissioner of Food Safety was placed on record. By the order dated 13.01.2023, the learned Senior Government Pleader was directed to get instructions as to the testing facilities available at the laboratory at Pamba, under the Food Safety Commissionerate, Kerala, and the learned Standing Counsel for Travancore Devaswom Board was directed to make available for the perusal of this Court, the entire files relating to the tender process pursuant to Exts.P3, P6 and P9 and also Ext.R1(a) notification dated 04.11.2022, on the next posting date. 17. On 17.01.2023, when W.P.(C)No.41743 of 2022 came up for consideration, the learned Standing Counsel for Travancore Devaswom Board produced the files relating to the tender process pursuant to Exts.P3, P6 and P9 and also Ext.R1(a) notification dated 04.11.2022. Registry was directed to keep the files in the safe custody of Registrar (Judicial) and the writ petition was ordered to be listed on 19.01.2023 for further consideration. 18. On 19.01.2023, when W.P.(C)No.41743 of 2022 came up for consideration, we have perused the files handed over by the learned Standing Counsel for Travancore Devaswom Board. Registry was directed to keep the files in the safe custody of Registrar (Judicial) and the writ petition was ordered to be listed on 19.01.2023 for further consideration. 18. On 19.01.2023, when W.P.(C)No.41743 of 2022 came up for consideration, we have perused the files handed over by the learned Standing Counsel for Travancore Devaswom Board. As per the relevant files, there were three e-tender notifications for procuring cardamom and other items during Mandala-Makaravilakku festival season of 1198 ME (2022-23), i.e., Exts.P3, P6 and P9 e-tender notifications. In terms of the tender conditions in those e-tender notifications, the sample of cardamom taken from each supplier was sent for analysis before the Government Analyst’s Laboratory, Thiruvananthapuram. On all three occasions, the samples failed to meet the requirements under the Food Safety and Standards (Contaminants, Toxins and Residues) Regulation, 2011, since they contained residues exceeding the Maximum Residue Limit (MRL) as per the said Regulations. It is thereafter that a decision has been taken by the Travancore Devaswom Board, whereby the Executive Officer, Sabarimala Devaswom was authorised to procure cardamom and also certain other items, by local purchase. Instead of going for local purchase, the Executive Officer published a notification at Sannidhanam, inviting quotations from suppliers. Based on that notification, four quotations were received including that of the 2nd respondent herein. Out of the four samples of cardamom sent for analysis before the Laboratory at Pamba, under the Food Safety Commissionerate, Kerala, two samples failed to meet the requirements under the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. Out of the suppliers of other two samples, the price quoted by the 2nd respondent herein was the lowest. 19. On 19.01.2023, the learned Standing Counsel for Travancore Devaswom Board submitted that since the price quoted by the 2nd respondent herein for supply of cardamom was the lowest, the Executive Officer placed the proposal of the 2nd respondent herein for supply of cardamom, before the Devaswom Commissioner for negotiation. The Devaswom Commissioner negotiated with the 2nd respondent herein and thereafter, the matter was placed before the Travancore Devaswom Board for further negotiation. The decision taken by the Board to accept the proposal of the 2nd respondent herein was communicated to the Executive Officer, through the Devaswom Commissioner. Based on that decision, the Executive Officer issued supply order to the 2nd respondent herein for supply of cardamom. The decision taken by the Board to accept the proposal of the 2nd respondent herein was communicated to the Executive Officer, through the Devaswom Commissioner. Based on that decision, the Executive Officer issued supply order to the 2nd respondent herein for supply of cardamom. In the order dated 19.01.2023, we noticed that, a perusal of the files relating to Exts.P3, P6 and P9 e-tender notifications and also Ext.R1(a) notification would show that a similar procedure has been followed in respect of other items as well, during the Mandala-Makaravilakku festival season of 1198 ME. 20. In terms of the direction contained in the order dated 13.01.2023, the Commissioner of Food Safety has submitted a report dated 17.01.2023 as to the testing facilities available at the laboratory at Pamba, under the Food Safety Commissionerate, Kerala. In the said report it is stated that this Court ordered in SSCR No.1 of 2012 that the production, making and handling of Aravana shall be in strict conformity with the contents of the report of the learned Ombudsman and the report of the Commissioner of Food Safety, Kerala. It was further ordered that testing labs shall be functional during the monthly pooja period also apart from Mandala-Makaravilakku season for a complete regulatory measure in place regarding the procurement of raw materials, manufacture, packing and handling of Aravana in Sabarimala. Having regard to the order passed in SSCR No.1 of 2012 and the report of the Joint Commissioner of Food Safety, this Court directed the Travancore Devaswom Board to ensure that the standards prescribed by the Food Safety Commissionerate, Kerala for preparation of Aravana are maintained scrupulously and in any case any batch of Aravana is found to be not conforming to the standards, the same shall not be distributed to the devotees. On the basis of the directions issued by this Court, two analytical laboratories were set up at Pamba and Sannidhanam, which are functional since 2012, under the control of the Commissioner of Food Safety, Kerala. Infrastructure for the analytical laboratories was provided by the Travancore Devaswom Board and technical and analytical staff were posted by the Commissioner of Food Safety. All raw materials for Aravana are being stored at Pamba godown and being analysed at the Analytical Laboratory at Pamba. The raw materials conforming to the standards alone are transported to Sannidhanam for the preparation of Aravana and Appam. All raw materials for Aravana are being stored at Pamba godown and being analysed at the Analytical Laboratory at Pamba. The raw materials conforming to the standards alone are transported to Sannidhanam for the preparation of Aravana and Appam. If any re-examination is needed, the article will be analysed at Government Analyst’s Laboratory, Thiruvananthapuram for confirmation of test results. The prepared Aravana and Appam are being analysed at the Analytical Laboratory in Sannidhanam. As per the report dated 17.01.2023 of the Commissioner of Food Safety, Kerala, the Analytical Laboratory at Pamba has the facility to test the quality standards and synthetic food colour of raw materials used for preparation of prasadam, which includes Cardamom. In respect of Cardamom, the following parameters are being tested at Pamba. “1. Mould growth & Rodent contamination 2. Dead and living insects, Insect fragments 3. Extraneous matter 4. Empty and malformed capsules by count 5. Moisture 6. Total ash on dry weight basis 7. Volatile oil content on dry weight basis 8. Test for synthetic food colour 9. Insect damaged matter 10. Immature and shrivelled capsules.” The equipment available in the analytical laboratories at Pamba to test the quality parameters for Aravana and that available at Sannidhanam to test the quality parameters for Aravana are furnished in the report dated 17.01.2023 of the Commissioner of Food Safety. 21. In the order dated 19.01.2023, we noticed that the facilities for testing cardamom and other items with reference to the requirements of the Food Safety and Standards (Contaminants, Toxins and Residues) Regulation, 2011, are not available at the Laboratory at Pamba, under the Food Safety Commissionerate, Kerala, where the testing parameters are with reference to the provisions under the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. When the samples of cardamom in respect of Exts.P3, P6 and P9 e-tender notifications failed to meet the requirements of the Food Safety and Standards (Contaminants, Toxins and Residues) Regulation, 2011, in the testing conducted at Government Analyst’s Laboratory, Thiruvananthapuram, even when it is decided by the Travancore Devaswom Board to go for local purchase for procuring cardamom and other items, before accepting the quotations by the suppliers, the Board should have ensured that the sample of cardamom meets the requirements of the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 and also the requirements under the Food Safety and Standards (Contaminants, Toxins and Residues) Regulation, 2011. 22. In the order dated 19.01.2023 in W.P.(C)No.41743 of 2022, we found that a proper food safety audit at Sabarimala is highly essential in order to ensure strict compliance of the statutory requirements of the Food Safety and Standards Act, 2006 and also the Rules and Regulations made thereunder, including the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 and the Food Safety and Standards (Contaminants, Toxins and Residues) Regulation, 2011. In such circumstances, by the order dated 19.01.2023, we directed Registry to register a suo motu proceedings in order to ensure strict compliance of the statutory requirements of the Food Safety and Standards Act, 2006 and also the Rules and Regulations made thereunder, including the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 and the Food Safety and Standards (Contaminants, Toxins and Residues) Regulation, 2011 at Sabarimala in the preparation of Aravana Prasadam, Appam Prasadam, etc., which is now pending consideration as DBP No.4 of 2023. 23. Food Safety and Standards Act, 2006 (for brevity, ‘the Act’) is enacted by Parliament to consolidate the laws relating to food and to establish the Food Safety and Standards Authority of India for laying down science-based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import, to ensure availability of safe and wholesome food for human consumption and for matters connected therewith or incidental thereto. 24. 24. In Centre for Public Interest Litigation v. Union of India and others [ (2013) 16 SCC 279 ], the Apex Court held that any food article which is hazardous or injurious to public health is a potential danger to the fundamental right to life guaranteed under Article 21 of the Constitution of India. A paramount duty is cast on the States and its authorities to achieve an appropriate level of protection to human life and health which is a fundamental right guaranteed to the citizens under Article 21 read with Article 47 of the Constitution of India. 25. In Swami Achyutanand Tirth v. Union of India [ (2016) 9 SCC 699 ] the Apex Court noticed that some of the objectives of the Food Safety and Standards Act are as follows; (i) to consolidate the laws relating to food, (ii) to establish Food Safety and Standards Authority of India for laying down science-based standards for articles of food, (iii) to regulate their manufacture, storage, distribution, sale and import, (iv) to ensure availability of safe and wholesome food for human consumption. The Act, apart from making more stringent provisions (e.g. prescribing higher penalties, etc.) to curb food adulteration, also ushers in new concepts such as putting in place food safety management systems and food safety audits to realise its ultimate goal of ensuring the availability of safe and wholesome food for human consumption. In order to ensure food safety, effective food safety systems implementation and to ensure that food producers and suppliers operate responsibly and supply safe food to consumers, the Act further stipulates (i) licensing for the manufacture of food products, which is presently granted by the Central agencies under various Acts and orders, would stand decentralised to the Commissioner of Food Safety and his office, (ii) single reference point for all matters relating to food safety and standards, regulations and enforcement, (iii) shift from mere regulatory regime to self-compliance through food safety management systems, (iv) responsibility on food business operators to ensure that food processed, manufactured, imported or distributed is in compliance with the domestic food laws. 26. Clause (a) of Section 3(1) of the Act defines ‘adulterant’ to mean any material which is or could be employed for making the food unsafe or sub-standard or mis-branded or containing extraneous matter. 26. Clause (a) of Section 3(1) of the Act defines ‘adulterant’ to mean any material which is or could be employed for making the food unsafe or sub-standard or mis-branded or containing extraneous matter. Clause (g) of Section 3(1) of the Act defines ‘contaminant’ to mean any substance, whether or not added to food, but which is present in such food as a result of the production (including operations carried out in crop husbandry, animal husbandry or veterinary medicine), manufacture, processing, preparation, treatment, packing, packaging, transport or holding of such food or as a result of environmental contamination and does not include insect fragments, rodent hairs and other extraneous matter. 27. Clause (j) of Section 3(1) of the Act defines ‘food’ to mean any substance, whether processed, partially processed or unprocessed, which is intended for human consumption and includes primary food to the extent defined in clause (zk), genetically modified or engineered food or food containing such ingredients, infant food, packaged drinking water, alcoholic drink, chewing gum, and any substance, including water used into the food during its manufacture, preparation or treatment but does not include any animal feed, live animals unless they are prepared or processed for placing on the market for human consumption, plants prior to harvesting, drugs and medicinal products, cosmetics, narcotic or psychotropic substances. As per the proviso to clause (f) of Section 3(1), the Central Government may declare, by notification in the Official Gazette, any other article as food for the purposes of this Act having regards to its use, nature, substance or quality. 28. Clause (k) of Section 3(1) of the Act defines ‘food additive’ to mean any substance not normally consumed as a food by itself or used as a typical ingredient of the food, whether or not it has nutritive value, the intentional addition of which to food for a technological (including organoleptic) purpose in the manufacture, processing, preparation, treatment, packing packaging, transport or holding of such food results, or may be reasonably expected to result (directly or indirectly), in it or its by-products becoming a component of or otherwise affecting the characteristics of such food but does not include ‘contaminants’ or substances added to food for maintaining or improving nutritional qualities. 29. 29. Clause (n) of Section 3(1) of the Act defines ‘food business’ to mean any undertaking, whether for profit or not and whether public or private, carrying out any of the activities related to any stage of manufacture, processing, packaging, storage, transportation, distribution of food, import and includes food services, catering services, sale of food or food ingredients. Clause (o) of Section 3(1) defines ‘food business operator’ in relation to food business to mean a person by whom the business is carried on or owned and is responsible for ensuring the compliance of the Act, rules and regulations made thereunder. 30. Clause (q) of Section 3(1) of the Act defines ‘food safety’ to mean an assurance that food is acceptable for human consumption according to its intended use. Clause (u) of Section 3(1) defines ‘hazard’ to mean a biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect. Clause (y) of Section 3(1) defines ‘ingredient’ to mean any substance, including a food additive used in the manufacture or preparation of food and present in the final product, possibly in a modified form. Clause (zc) of Section 3(1) defines ‘manufacture’ to mean a process or adoption or any treatment for conversion of ingredients into an article of food, which includes any sub-process, incidental or ancillary to the manufacture of an article of food. Clause (zd) of Section 3(1) defines ‘manufacturer’ to mean a person engaged in the business of manufacturing any article of food for sale and includes any person who obtains such article from another person and packs and labels it for sale or only labels it for such purposes. 31. Clause (zd) of Section 3(1) defines ‘manufacturer’ to mean a person engaged in the business of manufacturing any article of food for sale and includes any person who obtains such article from another person and packs and labels it for sale or only labels it for such purposes. 31. Clause (zf) of Section 3(1) of the Act defines ‘misbranded food’, which reads thus; “(zf) ‘misbranded food’ means an article of food- (A) if it is purported, or is represented to be, or is being- (i) offered or promoted for sale with false, misleading or deceptive claims either- (a) upon the label of the package, or (b) through advertisement, or (ii) sold by a name which belongs to another article of food; or (iii) offered or promoted for sale under the name of a fictitious individual or company as the manufacturer or producer of the article as borne on the package or containing the article or the label on such package; or (B) if the article is sold in packages which have been sealed or prepared by or at the instance of the manufacturer or producer bearing his name and address but- (i) the article is an imitation of, or is a substitute for, or resembles in a manner likely to deceive, another article of food under the name of which it is sold, and is not plainly and conspicuously labelled so as to indicate its true character; or (ii) the package containing the article or the label on the package bears any statement, design or device regarding the ingredients or the substances contained therein, which is false or misleading in any material particular, or if the package is otherwise deceptive with respect to its contents; or (iii) the article is offered for sale as the product of any place or country which is false; or (C) if the article contained in the package- (i) contains any artificial flavouring, colouring or chemical preservative and the package is without a declaratory label stating that fact is not labelled in accordance with the requirements of this Act or regulations made thereunder or is in contravention thereof; or (ii) is offered for sale for special dietary uses, unless its label bears such information as may be specified by regulation, concerning its vitamins, minerals or other dietary properties in order sufficiently to inform its purchaser as to its value for such use; or (iii) is not conspicuously or correctly stated on the outside thereof within the limits of variability laid down under this Act.” 32. Clause (zk) of Section 3(1) of the Act defines ‘primary food’ to mean an article of food, being a produce of agriculture or horticulture or animal husbandry and dairying or aquaculture in its natural form, resulting from the growing, raising, cultivation, picking, harvesting, collection or catching in the hands of a person other than a farmer or fisherman. Clause (zr) of Section 3(1) defines ‘sale’ with its grammatical variations and cognate expressions, means the sale of any article of food, whether for cash or on credit or by way of exchange and whether by wholesale or retail, for human consumption or use, or for analysis, and includes an agreement for sale, an offer for sale, the exposing for sale or having in possession for sale of any such article, and includes also an attempt to sell any such article. 33. Clause (zu) of Section 3(1) of the Act defines ‘standard’, in relation to any article of food, to mean the standards notified by the Food Authority, i.e., the Food Safety and Standards Authority of India established under Section 4 of the Act. Clause (zw) of Section 3(1) defines ‘substance’ to include any natural or artificial substance or other matter, whether it is in a solid state or in liquid form or in the form of gas or vapour. As per clause (zx) of Section 3(1), which defines ‘sub-standard’, an article of food shall be deemed to be sub-standard if it does not meet the specified standards but not so as to render the article of food unsafe. 34. As per clause (zx) of Section 3(1), which defines ‘sub-standard’, an article of food shall be deemed to be sub-standard if it does not meet the specified standards but not so as to render the article of food unsafe. 34. Clause (zz) of Section 3(1) of the Act defines ‘unsafe food’, which reads thus; “(zz) ‘unsafe food’ means an article of food whose name, substance or quality is so affected as to render it injurious to health:- (i) by the article itself, or its package thereof, which is composed, whether wholly or in part, of poisonous or deleterious substances; or (ii) by the article consisting, wholly or in part, of any filthy, putrid, rotten, decomposed or diseased animal substance or vegetable substance; or (iii) by virtue of its unhygienic processing or the presence in that article of any harmful substance; or (iv) by the substitution of any inferior or cheaper substance whether wholly or in part; or (v) by addition of a substance directly or as an ingredient which is not permitted; or (vi) by the abstraction, wholly or in part, of any of its constituents; or (vii) by the article being so coloured, flavoured or coated, powdered or polished, as to damage or conceal the article or to make it appear better or of greater value than it really is; or (viii) by the presence of any colouring matter or preservatives other than that specified in respect thereof; or (ix) by the article having been infected or infested with worms, weevils or insects; or (x) by virtue of its being prepared, packed or kept under insanitary conditions; or (xi) by virtue of its being misbranded or substandard or food containing extraneous matter; or (xii) by virtue of containing pesticides and other contaminants in excess of quantities specified by regulations.” 35. Section 16 of the Act deals with duties and functions of Food Authority, i.e., the Food Safety and Standards Authority of India established under Section 4 of the Act. As per sub-section (1) of Section 16, it shall be the duty of the Food Authority to regulate and monitor the manufacture, processing, distribution, sale and import of food so as to ensure safe and wholesome food. As per sub-section (2) of Section 16, without prejudice to the provisions of sub-section (1), the Food Authority may by regulations specify the matters enumerated in clauses (a) to (i). As per sub-section (2) of Section 16, without prejudice to the provisions of sub-section (1), the Food Authority may by regulations specify the matters enumerated in clauses (a) to (i). Such regulations may specify, as per clause (a), the standards and guidelines in relation to articles of food and an appropriate system for enforcing various standards notified under this Act; and as per clause (b), the limits for use of food additives, crop contaminants, pesticide residues, residues of veterinary drugs, heavy metals, processing aids, mycotoxins, antibiotics and pharmacological active substances and irradiation of food. As per sub-section (5) of Section 16, the Food Authority may, from time to time give such directions, on matters relating to food safety and standards, to the Commissioner of Food Safety, who shall be bound by such directions while exercising his powers under the Act. 36. Section 18 of the Act deals with general principles to be followed in the administration of the said Act. As per Section 18, the Central Government, the State Governments, the Food Authority and other agencies, as the case may be, while implementing the provisions of the Act shall be guided by the principles enumerated in clauses (a) to (g) of sub-section (1). While framing regulations or specifying standards under the Act, the Food Authority shall take into account the matters enumerated in clauses (a) to (f) of sub-section (2). As per sub-section (3) of Section 18, the provisions of the Act shall not apply to any farmer or fisherman or farming operations or crops or livestock or aquaculture, and supplies used or produced in farming of products of crops produced by a farmer at farm level or a fisherman in his operations. 37. Section 19 of the Act deals with use of food additives or processing aid. As per Section 19, no article of food shall contain any food additive or processing aid unless it is in accordance with the provisions of the Act and regulations made thereunder. 37. Section 19 of the Act deals with use of food additives or processing aid. As per Section 19, no article of food shall contain any food additive or processing aid unless it is in accordance with the provisions of the Act and regulations made thereunder. As per the Explanation to Section 19, for the purposes of this Section, ‘processing aid’ means any substance or material, not including apparatus or utensils, and not consumed as a food ingredient by itself, used in the processing of raw materials, foods or its ingredients to fulfil a certain technological purpose during treatment or processing and which may result in the non-intentional but unavoidable presence of residues or derivatives in the final product. 38. Section 20 of the Act deals with contaminants, naturally occurring toxic substances, heavy metals, etc. As per Section 20, no article of food shall contain any contaminant, naturally occurring toxic substances or toxins or hormones or heavy metals in excess of such quantities as may be specified by regulations. Section 21 of the Act deals with pesticides, veterinary drugs residues, antibiotic residues and micro-biological counts. As per sub-section (1) of Section 21, no article of food shall contain insecticides or pesticide residues, veterinary drugs residues, antibiotic residues, solvent residues, pharmacologically active substances and micro-biological counts in excess of such tolerance limits as may be specified by regulations. As per sub-section (2) of Section 21, no insecticide shall be used directly on an article of food except fumigants registered and approved under the Insecticides Act, 1968. As per the Explanation to Section 21 of the Act, for the purposes of this Section, ‘pesticide residue’ means any specified substance in food resulting from the use of a pesticide and includes any derivatives of a pesticide, such as conversion products, metabolites, reaction products and impurities considered to be of toxicological significance and also includes such residues coming into food from the environment; and ‘residues of veterinary drugs’ include the parent compounds or their metabolites or both in any edible portion of any animal product and include residues of associated impurities of the veterinary drug concerned. 39. Section 22 of the Act deals with genetically modified foods, organic foods, functional foods, proprietary foods, etc. 39. Section 22 of the Act deals with genetically modified foods, organic foods, functional foods, proprietary foods, etc. As per Section 22 of the Act, save as otherwise provided under the Act and regulations made thereunder, no person shall manufacture, distribute, sell or import any novel food, genetically modified articles of food, irradiated food, organic food, foods for special dietary uses, functional foods, neutraceuticals, health supplements, proprietary foods and such other articles of food which the Central Government may notify in this behalf. As per Explanation (4) to Section 22, ‘proprietary and novel food’ means an article of food for which standards have not been specified but is not unsafe. As per the proviso to Section 22, such food does not contain any of the foods and ingredients prohibited under the Act and the regulations made thereunder. 40. Section 26 of the Act deals with responsibilities of food business operator. As per sub-section (1) of Section 26, every food business operator shall ensure that the articles of food satisfy the requirements of the Act and the rules and regulations made thereunder at all stages of production, processing, import, distribution and sale within the businesses under his control. Section 26 of the Act reads thus; “26. Responsibilities of the food business operator.- (1) Every food business operator shall ensure that the articles of food satisfy the requirements of this Act and the rules and regulations made thereunder at all stages of production, processing, import, distribution and sale within the businesses under his control. (2) No food business operator shall himself or by any person on his behalf manufacture, store, sell or distribute any article of food- (i) which is unsafe; or (ii) which is misbranded or sub-standard or contains extraneous matter; or (iii) for which a licence is required, except in accordance with the conditions of the licence; or (iv) which is for the time being prohibited by the Food Authority or the Central Government or the State Government in the interest of public health; or (v) in contravention of any other provision of this Act or of any rule or regulation made thereunder. (3) No food business operator shall employ any person who is suffering from infectious, contagious or loathsome disease. (3) No food business operator shall employ any person who is suffering from infectious, contagious or loathsome disease. (4) No food business operator shall sell or offer for sale any article of food to any vendor unless he also gives a guarantee in writing in the form specified by regulations about the nature and quality of such article to the vendor: Provided that a bill, cash memo, or invoice in respect of the sale of any article of food given by a food business operator to the vendor shall be deemed to be a guarantee under this section, even if a guarantee in the specified form is not included in the bill, cash memo or invoice. (5) Where any food which is unsafe is part of a batch, lot or consignment of food of the same class or description, it shall be presumed that all the food in that batch, lot or consignment is also unsafe, unless following a detailed assessment within a specified time, it is found that there is no evidence that the rest of the batch, lot or consignment is unsafe: Provided that any conformity of a food with specific provisions applicable to that food shall be without prejudice to the competent authorities taking appropriate measures to impose restrictions on that food being placed on the market or to require its withdrawal from the market for the reasons to be recorded in writing where such authorities suspect that, despite the conformity, the food is unsafe.” 41. Section 27 of the Act deals with liability of manufacturers, packers, wholesalers, distributors and sellers. As per sub-section (1) of Section 27, the manufacturer or packer of an article of food shall be liable for such article of food if it does not meet the requirements of the Act and the rules and regulations made thereunder. Section 27 of the Act reads thus; “27. Liability of manufacturers, packers, wholesalers, distributors and sellers.- (1) The manufacturer or packer of an article of food shall be liable for such article of food if it does not meet the requirements of this Act and the rules and regulations made thereunder. Section 27 of the Act reads thus; “27. Liability of manufacturers, packers, wholesalers, distributors and sellers.- (1) The manufacturer or packer of an article of food shall be liable for such article of food if it does not meet the requirements of this Act and the rules and regulations made thereunder. (2) The wholesaler or distributor shall be liable under this Act for any article of food which is- (a) supplied after the date of its expiry; or (b) stored or supplied in violation of the safety instructions of the manufacturer; or (c) unsafe or misbranded; or (d) unidentifiable of manufacturer from whom the articles of food have been received; or (e) stored or handled or kept in violation of the provisions of this Act, the rules and regulations made thereunder; or (f) received by him with knowledge of being unsafe. (3) The seller shall be liable under this Act for any article of food which is- (a) sold after the date of its expiry; or (b) handled or kept in unhygienic conditions; or (c) misbranded; or (d) unidentifiable of the manufacturer or the distributors from whom such articles of food were received; or (e) received by him with knowledge of being unsafe.” 42. Section 91 of the Act deals with power of Central Government to make rules; Section 92 deals with power of Food Authority, i.e., the Food Safety and Standards Authority of India established under Section 4 of the Act, to make regulations; and Section 94 deals with power of State Government to make rules. As per Section 92(1) of the Act, the Food Authority may, with the previous approval of the Central Government and after previous publication, by notification, make regulations consistent with the Act and the rules made thereunder to carry out the provisions of this Act. As per clause (e) of sub-section (2) of Section 92, such regulations may provide for standards and guidelines in relation to articles of food meant for human consumption under sub-section (2) of Section 16; as per clause (i) of sub-section (2) of Section 92, limits of quantities of contaminants, toxic substances and heavy metals, etc. under Section 20; and as per clause (j) of sub-section (2) of Section 92, tolerance limits of pesticides, veterinary drugs residues, etc., under Section 21. 43. under Section 20; and as per clause (j) of sub-section (2) of Section 92, tolerance limits of pesticides, veterinary drugs residues, etc., under Section 21. 43. In exercise of the powers conferred by clauses (i) and (j) of sub-section (2) of Section 92 read with Sections 20 and 21 of Food Safety and Standards Act, 2006 (34 of 2006), the Food Safety and Standards Authority of India made Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011. Regulation 1.2. deals with definitions. Clause 1 of sub-regulation 1.2.1. defines ‘crop contaminant’ to mean any substance not intentionally added to food, but which gets added to articles of food in the process of their production (including operations carried out in crop husbandry, animal husbandry and veterinary medicine), manufacture, processing, preparation, treatment, packing, packaging transport or holding of articles of such food as a result of environmental contamination. Chapter 2 of the Regulations deals with contaminants, toxins and residues. Regulation 2.1. deals with metal contaminants; Regulation 2.2. deals with crop contaminants and naturally occurring toxic substances; and Regulation 2.3. deals with residues. 44. Sub-regulation 2.3.1. of Food Safety and Standards (Contaminants, Toxins and Residues) Regulations deals with restriction on the use of insecticides. As per clause (1) of Sub-regulation 2.3.1., the expression ‘insecticide’ shall have the meaning assigned to it in the Insecticides Act, 1968. As per clause (2), subject to the provisions of clause (3), no insecticides shall be used directly on articles of food. As per the proviso to clause (2), nothing in this regulation shall apply to the fumigants which are registered and recommended for use as such on articles of food by the Registration Committee constituted under Section 5 of the Insecticides Act. As per clause (3), the insecticide specified in column (2) of the table shall not exceed the Maximum Residue Limits (MRL) prescribed in column (4), for the article of food specified in column (3) of the said table. The Maximum Residue Limits (MRL) of insecticides specified in the said table for cardamom read thus; Sl.No. Name of Insecticides Food Maximum Residue Limits (MRL) in mg/kg 43. Copper Oxychloride (Copper determined as elemental copper) Cardamom $ 44. Copper Sulphate (Copper determined as elemental copper Cardamom $ 52. Diafenthiuron Cardamom 0.5 93. Fosetyl-Al Cardamom 0.2 129. Monocrotophos Cardamom 0.5 163. The Maximum Residue Limits (MRL) of insecticides specified in the said table for cardamom read thus; Sl.No. Name of Insecticides Food Maximum Residue Limits (MRL) in mg/kg 43. Copper Oxychloride (Copper determined as elemental copper) Cardamom $ 44. Copper Sulphate (Copper determined as elemental copper Cardamom $ 52. Diafenthiuron Cardamom 0.5 93. Fosetyl-Al Cardamom 0.2 129. Monocrotophos Cardamom 0.5 163. Quinalphos Cardamom 0.01 $: The limit shall be for copper in the regulations 2.1 metal contaminants of the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011 and as amended from time to time. Note: Tolerance limit of 0.01 mg/kg shall apply in cases of pesticides for which MRL have not been fixed. 45. In exercise of the powers conferred by clause (e) of sub-section (2) of Section 92, read with Section 16 of the Food Safety and Standards Act, the Food Safety and Standards Authority of India made the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. Regulation 2.9 deals with salt, spices, condiments and related products. Sub-regulation 2.9.2 deals with cardamom (elaichi), which reads thus; 2.9.2 Cardamom (Elaichi): 1. Cardamom (Chhoti Elaichi) Whole means the dried capsules of nearly ripe fruits of Elettaria cardamomum L. Maton Var. Minuscula Burkill. The capsules may be light green to brown or pale cream to white when bleached with sulphur dioxide. It shall have characteristic flavour free from any foreign odour, mustiness or rancidity. It shall be free from mould, living and dead insects, insect fragments, rodent contamination. Thrip marks alone should not lead to the conclusion that the capsules have been infested with insects. The product shall be free from added colouring matter and other harmful substances. It shall conform to the following standards:- (i) Extraneous matter Not more than 1.0% by weight (ii) Empty and malformed capsules by count Not more than 3.0% by count (iii) Immature and shrivelled capsules Not more than 3.0% by weight (iv) Moisture Not more than 13.0% by weight (v) Total ash on dry basis Not more than 9.5% by weight (vi) Volatile oil content on dry basis Not less than 3.5% by v/w (vii) Insect damaged matter Not more than 1.0% by weight 2. Cardamom (Chhoti Elaichi) seeds means the decorticated seeds separated from the dried capsules of nearly ripe fruits of Elettaria Cardamomum L. Maton var miniscula Burkill. Cardamom (Chhoti Elaichi) seeds means the decorticated seeds separated from the dried capsules of nearly ripe fruits of Elettaria Cardamomum L. Maton var miniscula Burkill. The seeds shall have characteristic flavour free from foreign odour, mustiness or rancidity. It shall be free from mould, living and dead insects, insect fragments, rodent contamination. The product shall be free from added colouring matter and any other harmful substances. It shall conform to the following standards:- (i) Extraneous matter Not more than 2.0% by weight (ii) Light seeds Not more than 3.0% by weight (iii) Moisture Not more than 13.0% by weight (iv) Total ash on dry basis Not more than 9.5% by weight (v) Volatile oil content on dry basis Not less than 3.5% by v/w (vi) Insect damaged matter Not more than 1.0% by weight Explanation.—Light seeds mean seeds that are brown or red in colour and broken immature and shrivelled seeds.