The Food Safety and Standards Authority of India (FSSAI) has the authority to issue advisories, including the impugned advisory dated 11.5.2013, which provides for a product approval procedure for food businesses. This authority is derived from Sections 16(1), 16(5), and 18 of the Food Safety and Standards Act, 2006 (FSS Act), which empower the FSSAI to regulate and monitor the manufacture, processing, distribution, sale, and import of food to ensure safe and wholesome food for human consumption.

G.S. Kulkarni, J.

1. I have had the privilege of going through the erudite judgment of my learned brother Mr. Justice V.M. Kanade. Having deliberated over the arguments advanced by the learned Counsel for contesting parties in the light of the statutory provisions and authoritative pronouncement of the Supreme Court, I deeply regret my inability to persuade myself to share the view of my learned brother. Hence, this Judgment.

2. Rule. Rule is made returnable forthwith. By consent of parties , heard finally.

3. By this petition filed under Article 226 of the Constitution of India, two petitioners viz. Vital Nutraceuticals Private Ltd.-Petitioner no.1 and Indian Drug Manufacturers' Association-Petitioner no.2 having 690 members as listed in the Statement annexed at 'Exhibit C' to the petition, have inter alia challenged the action of Respondent no.2 viz. Food Safety and Standards Authority of India (hereinafter referred to as 'the Food Authority') in issuing advisories in respect of various issues falling under the Food Safety and Standards Act,2006 and more particularly the advisory dated 11.5.2013 which lays down the guidelines to be followed for the

'Product Approval Procedure'. The challenge has been confined to this advisory.

4. The facts relevant for adjudication of dispute in the present proceedings are as under:-

The Parliament enacted the Food Safety and Standards Act,2006 (hereinafter referred to as “FSS Act,2006”) repealing the Prevention of Food Adulteration Act,1954, the Fruit Products Order,1955, the Meat Food Products Order,1973, the Vegetable Oil Products (Control) Order,1947, the Edible Oils Packaging (Regulation) Order,1998, the Solvent Extracted Oil, De oiled Meal, and Edible Flour (Control) Order,1967, the Milk and Milk Products Order,1992, any other orders issued under the Essential Commodities Act,1955 relating food. All these repealed Acts and Orders are enumerated in the Second Schedule of the FSS Act forming part of the repeal provision being Section 97 of the FSS Act. The preamble of the FSS Act recites that it is an Act 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.

5. The Statement of Objects and Reasons of the FSS Act inter-alia sets out in detail that the then Member-Secretary, Law Commission of India, was asked to make a comprehensive review of Food Laws of various developing and developed countries and other relevant international agreements and instruments on the subject. That after making an indepth survey of the International scenario, the then Member- Secretary recommended that the new Food Law be seen in the overall perspective of promoting nascent food processing industry given its income, employment and export potential. That it has been suggested that all acts and orders relating to food be subsumed within the proposed integrated Food Law as the international trend is towards modernization and convergence of regulations of Food Standards with the elimination of multi-level and multi-departmental control. That presently, the emphasis was on (a) responsibility with manufacturers, (b) recall, (c) genetically modified and functional foods, (d) emergency control, (e) risk analysis and communication and (f) food safety and good manufacturing practices and process control, viz. Hazard Analysis and Critical Control Point. It further recites that in this background, the Group of Ministers constituted by the Government of India, held extensive deliberations and approved the proposed Integrated Food Law with certain modifications. The Integrated Food Law was named as “The Food Safety and Standards Bill,2005”. That the main object of the Bill was to bring out a single statute re