Bombay High Court
Vital Nutraceuticals Private Limited vs Union Of India Through Secretary ... on 28 January, 2014
Author: V.M. Kanade
Bench: V. M. Kanade, Girish S. Kulkarni
1
WP2746.13
IN THE HIGH COURT OF JUDICATURE AT BOMBAY
ORDINARY ORIGINAL CIVIL JURISDICTION
WRIT PETITION NO. 2746 OF 2013
1. Vital Nutraceuticals Private Limited )
A company incorporated under the )
Companies Act, 1956 and a member of )
India Drug Manufacturers' Association a )
representative body of the Drugs )
Manufacturers (Pharmaceuticals) being
ig )
an institution formed by the )
manufacturers across the country )
registered under the Societies Registration )
Act, 1860 and having the registered Office )
at 102-B, 'A Wing', Poonam Chambers, Dr. )
Annie Besant Road, Worli, Mumbai 400 018 )
through its Director, Mr. Ganesh Vithal )
Kamath. )
)
2. Indian Drug Manufacturers' Associaiton )
a representative body of the Drugs )
Manufacturers (Pharmaceuticals) being an )
institution formed by the manufacturers )
across the country registered under the )
Societies Registration Act, 1860 and having )
its registered Office at 102-B, 'A Wing', )
Poonam Chambers, Dr. Annie Besant Road, )
Worli, Mumbai 400 018. )...Petitioners.
V/s
1. Union of India through Secretary Ministry )
of Health and Family Welfare, Government )
of India, (Department of Food) Nirman )
Bhavan, New Delhi - 110 011 )
::: Downloaded on - 13/02/2014 23:11:28 :::
2
WP2746.13
2. Food Safety and Standards Authority )
of India. FDA Bhavan, Near Bal Bhavan, )
Kotala Road, New Delhi-110 002. )....Respondents.
---
Mr. I. M. Chagla, Senior Counsel with Mr. Riyaz Chagla with
Mr. Rajeev Talasikar for the Petitioners.
Dr. G.R. Sharma with Mr. G.Hariharan with Mr. S.D. Bhosale
for Respondent No.1.
Mr. Mehmood Pracha with Mr. I.A. Khan i/b M/s. Legal Axis for
Respondent No.2.
----
CORAM: V. M. KANADE &
GIRISH S. KULKARNI, JJ.
Judgment reserved on: 22-01-2014
Judgment pronounced on : 28-1-2014
ORAL JUDGMENT: (Per V.M. Kanade, J.)
1. Heard.
2. Rule. Rule is made returnable forthwith. Respondents waive service. By consent of parties, matter is taken up for final hearing.
3. By this Petition which is filed under Article 226 of the Constitution of India, Petitioners, inter alia, are seeking an appropriate writ, order or direction for striking down or declaring as null and void all the the advisories which have been issued by Respondent No.2 and more particularly an ::: Downloaded on - 13/02/2014 23:11:28 ::: 3 WP2746.13 advisory dated 11/05/2013 primarily on the ground that Respondent No.2 does not have power or authority to issue these advisories which have an effect of amending Regulations which have been framed under section 92 of the Food Safety and Standards Act, 2006 and that they are illegal and without any statutory force; they being issued neither under section 92 of the Act nor having been in consonance with section 16(2) and 18(2)(d) of the Act.
4. On the other hand, it is contended by the learned Counsel appearing on behalf of Respondent No.2 that Respondent No.2 - Food Safety and Standards Authority of India has a power and authority to issue these Advisories by exercising power vested in it under sections 16(1) and 16(5) and under sections 18 and 22 of the Act and that they have been issued while exercising functions of the Chief Executive Officer under section 10 of the said Act. It is also contended that it is also in consonance with Regulation 2.1.2 and 2.1.7 of the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011.
FACTS:
5. Petitioner No.1 is a Private Limited Company incorporated under the provisions of the Companies Act, 1956 and is engaged in business of manufacture and supply ::: Downloaded on - 13/02/2014 23:11:28 ::: 4 WP2746.13 of foods for special dietary use, functional foods, nutraceuticals, health supplements, after obtaining requisite license under the erstwhile Act which was in force viz.
Prevention of Food Adulteration Act, 1954. This license was converted by issuance of fresh license under the provisions of the Food Safety and Standards Act, 2006 (hereinafter shall be referred to for the sake of brevity as "FSS Act, 2006")
6. Petitioner No.2 is a registered Association of drugs & pharmaceutical manufacturers in India and is a Society registered under the provisions of the Societies Registration Act, 1860. Respondent No.2 - Food Safety and Standards Authority is a body corporate having perpetual succession and a common seal and is established under section 4 of the FSS Act, 2006.
7. Petitioners have filed this Petition for quashing the instructions/directives termed as Advisories issued by Respondent No.2 to the various Food Officers under the Act and also Central & State Authorities and other Officers from time to time. These advisories have been issued by Respondent No.2 since 2010 and by the advisory dated 11/05/2013, the earlier advisories were superseded and, as such, the Petitioners therefore are now only challenging the advisory dated 11/05/2013.
::: Downloaded on - 13/02/2014 23:11:28 ::: 5WP2746.13 8 An affidavit-in-reply has been filed by Respondent No.2 dated 11/01/2014 and thereafter affidavit-in-rejoinder has been filed on behalf of the Petitioners on 20/01/2014.
REASONS:
9. Before taking into consideration the rival submissions, it would be relevant if the provisions of FSS Act, 2006 are taken into consideration. By virtue of the FSS Act, 2006 the Acts mentioned in the Second Schedule were repealed and the FSS Act, 2006 came into force with effect from 24/08/2006.
By this Act, the following Acts have been repealed.
"1. The Prevention of Food Adulteration Act, 1954 (37 of 1954)
2. The Fruit Products Order, 1955.
3. The Meat Food Products Order, 1973
4. The Vegetable Oil Products (Control) Order, 1947
5. The Edible Oils Packaging (Regulation) Order, 1998.
6. The Solvent Extracted Oil, De oiled Meal, and Edible Flour (Control) Order, 1967.
7. The Milk and Milk Products Order, 1992
8. Any other order issued under the Essential Commodities Act, 1955 (10 of 1955)"
The reason why the said Acts were repealed can be seen from the preamble of the new Act and also Statement of Objects and Reasons, which read as under:-
::: Downloaded on - 13/02/2014 23:11:28 ::: 6WP2746.13 "Statement of Objects and Reasons.-Multiplicity of food laws, standard setting and enforcement agencies pervades different sectors of food, which creates confusion in the minds of consumers, traders, manufacturers and investors. Detailed provisions under various laws regarding admissibility and levels of food additives, contaminants, food colours, preservatives, etc., and other related requirements have varied standards under these laws. The standards are often rigid and non-responsive to scientific advancements and modernisation. In view of multiplicity of laws, their enforcement and standard setting as well as various implementing agencies are detrimental to the growth of the nascent food processing industry and is not conducive to effective fixation of food standards and their enforcement.
2. In as early as in the year 1998, the Prime Minister's Council on Trade and Industry appointed a Subject Group on Food and Agro Industries, which had recommended for one comprehensive legislation on food with a Food Regulatory Authority concerning both domestic and export markets. Joint Parliamentary Committee on Pesticide Residues in its report in 2004 emphasised the need to coverage all present food laws and to have a single regulatory body. The Committee expressed its concern on public health and food safety in India. The Standing Committee of Parliament on Agriculture in its 12 th Report submitted in April, 2005 desired that the much-needed legislation on Integrated Food Law should be expedited.
3. As an ongoing process, 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. 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 ::: Downloaded on - 13/02/2014 23:11:28 ::: 7 WP2746.13 processing industry given its income, employment and export potential. 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 modernisation and convergence of regulations of Food Standards with the elimination of multi-level and multi-departmental control. Presently, the emphasis is on (a) responsibility with manufactures, (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.
4. In this background, the Group of Minsters constituted by the Government of India, held extensive delebrations and approved the proposed Integrated Food Law with certain modifications. The Integrated Food Law has been named as "The Food Safety and Standard Bill, 2005". The main objective of the Bill is to bring out a single statute relating to food and to provide for a systematic and scientific development of Food Processing Industries. It is proposed to establish the Food Safety and Standards Authority of India, which will fix food standards and regulate / monitor the manufacturing, import, processing, distribution and sale of food, so as to ensure safe and wholesome food for people. The Food Authority will be assisted by Scientific Committees and Panels in fixing standards and by a Central Advisory Committee in prioritization of the work. The enforcement of the legislation will be through the State Commissioner for Food Safety, his officers and Panchayati Raj / Municipal bodies.
5. The Bill, inter alia, incorporates the salient provisions of the Prevention of Food Adulteration Act, 1954 (37 of 1954) and is based on international legislations, instrumentalities and Codex Alimentaries Commission (which related to food safety norms). In a nutshell, the Bill takes care of International practices and invisages on overarching policy framework and provision of single window to guide and regulate persons engaged in manufacture, marketing, processing, handling, transportation, ::: Downloaded on - 13/02/2014 23:11:28 ::: 8 WP2746.13 import and sale of food. The main features of the Bill are:
(a) movement from multi-level and multi-
departmental control to integrated line of command;
(b) integrated response to strategic issues like noval / genetically modified foods, international trade;
(c) licensing for 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 officer;
(d) single reference point for all matters relating to Food Safety and Standards, regulations and enforcement;
(e) shift from mere regulatory regime to self-compliance through Food Safety Management Systems;
(f) responsibility on food business operators to ensure that food processed, manufactured, imported or distributed is in compliance with the domestic food laws; and
(g) provision for graded penalties depending on the gravity of offence and accordingly, civil penalties for minor offences and punishment for serious violations.
6. The abovesaid Bill is contemporary, comprehensive and intends to ensure better consumer safety through Food Safety Management Systems and setting standards based on science and transparency as also to meet the dynamic requirements of Indian Food Trade and Industry and International trade.
The Bill seeks to achieve the aforesaid
objectives."
10. Perusal of the said Statement of Objects and Reasons reveals that the intention of the legislature was to take care of International practices and also to provide for single window to guide and regulate persons engaged in ::: Downloaded on - 13/02/2014 23:11:28 ::: 9 WP2746.13 manufacture, marketing, processing, handling, transportation, import and sale of food. The Act, therefore, appears to have been brought into force to harmonize the interests of consumers and manufacturers to (1) ensure food safety; (2) protect the interest of the consumers;
(3) ensure safe and wholesome food for the people and, at the same time to ensure the growth of the nascent food processing industry.
Act, 2006.
11. It will be necessary to consider the Scheme of the FSS By virtue of the said Act, Food Safety and Standards Authority of India has been established. Chapter-II of the Act lays down the various authorities which have been established. It lays down the functions of the Food Authority as also the functions of Central Advisory Committee.
Chapter-III of the Act lays down general principles of food safety in section 18 of the said Act. Chapter-IV lays down the general provisions as to articles of food. Section 22 is in respect of genetically modified food, organic foods, functional foods, proprietary foods, etc and seeks to impose special responsibility on the food business operators.
Section 27 also prescribes the liability of manufacturers, packers, wholesalers, distributors and sellers. Section 28 envisages the procedure which has to be followed by the manufacturers for the purpose of recalling food products. Chapter-V deals with provisions relating to import. Chapter VI ::: Downloaded on - 13/02/2014 23:11:28 ::: 10 WP2746.13 deals with special responsibilities as to food safety. Chapter
-VII deals with the enforcement of the Act and the authorities which are responsible for the said enforcement. By virtue of Section 30, the duties of Commissioner of Food Safety of the State has been prescribed and Section 31 deals with licensing and registration of food business. The said Chapter also envisages situations where emergency prohibition notices could be issued and the prohibition orders could be passed by the authorities under the Act for the purpose of enforcement of the provisions of the Act. It also gives power to the authorities of search, seizure, investigation and prosecution. The procedure for launching the prosecution is laid down under section 42 of the Act. Chapter-VIII deals with analysis of food and prescribes the procedure for recognition and accreditation of laboratories, research institutions and referral food laboratory, appointment of the food analyst and functions of the food analyst. Chapter-IX deals with offences and penalties. Chapter-X is in respect of adjudication and food safety appellate tribunal and the power vested in the said appellate tribunal to adjudicate issues which are referred to it. Under section 76, appeal is provided to High Court. Chapter-XI deals with Finance Accounts, Audit and Reports and the last Chapter-XII deals with power of the Central Government to issue directions to the Food Authority and the procedure which is required to be followed in respect of taking approval from the Parliament in ::: Downloaded on - 13/02/2014 23:11:28 ::: 11 WP2746.13 respect of Rules and Regulations which are framed either by the Central Government or by the Food Authority. Section 97 deals with repeal and savings.
12. The relevant provisions which are germane for the purpose of deciding the issue raised in this Petition will be separately dealt with at the appropriate stage.
13. In the present case, the short issue which falls for consideration before this Court is : whether the advisories which have been issued by the Food Authority are without authority of law and whether the Food Authority has the power to issue these Advisories/directions without following the due procedure laid down under sections 92 and 93 of the FSS Act, 2006?
14. The contention of the Petitioners in this case is that the advisories which have been issued are without power and authority which can be exercised by the Food Authority and, therefore, are arbitrary, illegal and ultra vires the provisions of the FSS Act, 2006 and the Rules and Regulations framed thereunder.
15. A detailed affidavit-in-reply has been filed on behalf of Respondent No.2 and though in the reply it has not been stated what is the exact source of power vested in the Food ::: Downloaded on - 13/02/2014 23:11:28 ::: 12 WP2746.13 Authority for issuance of these advisories, it has been stated in the affidavit-in-reply that from conjoint reading of sections 10, 16(1), 16(5), 18, 22 as also section 29, power of the Food Authority in issuing these advisories can be seen. An affidavit-in-rejoinder has been filed on behalf of the Petitioner denying these contentions and averments which are made in the affidavit-in-reply.
16. Before we go into the rival contentions on the interpretation which is sought to be made by the learned Senior Counsel appearing on behalf of the Petitioners and the learned Senior Counsel appearing on behalf of the Respondents of the said provisions, it would be necessary to have a look at the advisories which have been issued.
Respondent No.2 - Food Authority was pleased to issue various advisories which have been mentioned as Press Note cum Advisory etc. from time to time. The first advisory which has been issued is dated 13/07/2010 and the last one is dated 11/5/2013. Since in the last advisory which has been issued, it is stated that the said advisory has been issued in supersession of earlier advisories, it may not be necessary to refer to and deal with earlier advisories which have been issued from time to time from 2010 to 2012. The Petition, therefore essentially challenges the advisory dated 11/05/2013 which has been put on the website of the Respondents. The said advisory/circular mentions the ::: Downloaded on - 13/02/2014 23:11:28 ::: 13 WP2746.13 subject as under:-
"Subject: Guidelines to be followed for product approval procedure."
In para 1 of the said advisory, it is stated that in view of feed back received from various stakeholders regarding the complexity and time lines for product approval and in order to streamline the product approval procedure with due consideration to the safety of food and public health, the food products for which the standards are not specified under the FSS Act, 2006, Rules and Regulations made thereunder will be granted product approval subject to the procedure which is to be followed. The procedure is referred to in para 1(a), 1(b), 1(c) and 1(d) and the other clauses of the said advisory. Clause 8 refers to the application fee of Rs 25,000/- which is payable in respect of each application. The product approval application form and the format of the affidavit are also annexed to the said advisory.
17. Mr. Chagla, the learned Senior Counsel appearing on behalf of the Petitioners submitted firstly that under the provisions of FSS Act, 2006 and the Rules and Regulations framed thereunder, the concept of prior product approval of products which are already in the market and in respect of existing products manufactured by Petitioner No.1 who had a ::: Downloaded on - 13/02/2014 23:11:28 ::: 14 WP2746.13 valid license under the erstwhile Food Adulteration Act was not envisaged under the provisions of the new Act and the Rules and Regulations framed thereunder. It is, therefore, submitted that the said concept of prior product approval was not in consonance with the provisions of the Act and the Rules and Regulations framed thereunder. It is submitted that the Food Authority has assumed the power to issue these Advisories and set up a new regime of obtaining prior product approval of existing products. He submitted that Petitioner No.1 was registered and was granted license under the Food Adulteration Act and was the manufacturer of products for the the last 10-15 years. He submitted that by virtue of the saving clause under section 97(3), existing licenses have been saved and, as such, there is no requirement under the new Act for such manufacturers to then apply for product approval of their existing products which are in the market before applying for registration under Regulation No.2.1.2 of the Food Safety and Standards (Licensing and Registration of Food Business) Regulations, 2011 which came into force from 01/08/2011 after it was published in the Government Gazette. It is submitted that the only way in which the Food Authority could bring into force the new procedure is by issuing the Regulation under section 16(2) of the Act after it is tabled before both the Houses of the Parliament as envisaged under section 93 of the said Act. The learned Senior Counsel appearing on ::: Downloaded on - 13/02/2014 23:11:28 ::: 15 WP2746.13 behalf of the Petitioners therefore submitted that the said procedure which has now been prescribed is illegal and without any authority of law.
18. On the other hand, the learned Counsel appearing on behalf of the Food Authority submitted that those manufacturers whose products fell in Schedule-1 of the FSS (Licensing and Registration of Food Business) Regulations, 2011 have to obtain licenses from the Central Agency or the State Agency. He submitted that the product which has been manufactured by the Petitioners fell in Category-VIII of Schedule-1 and, therefore, it was necessary to make an application under Regulation No.2.1.2 of the said Regulations, 2011. Secondly, he submitted that the Food Authority could establish that the action taken by it in issuing the said advisory was justified both on moral and legal ground. He submitted that he would first try to point out how the Food Authority was morally justified in issuing the said direction and at the end of his argument he would show the source of power which is exercised by the Food Authority in issuing the said advisory.
19. The learned Counsel appearing on behalf of the Respondents firstly submitted that various products were being dumped in the country and some of these products were manufactured by the Chinese manufacturers and that it ::: Downloaded on - 13/02/2014 23:11:28 ::: 16 WP2746.13 was brought to the notice of the Food Authority that the said products contained steroids which were harmful and the food was unsafe for human consumption. He then submitted that since the Act was at a nascent stage, it was not possible to formulate various Regulations in respect of all categories of food. He submitted that only in respect of 377 products, Regulations could be issued regarding various ingredients which were to be accepted. He submitted that, however, in respect of proprietary food and other categories of food, Regulations had not been framed and, therefore, in the interest of public at large and in order to ensure that food which was supplied to the consumer was not unsafe food, the Food Authority was constrained to issue these advisories. He then invited our attention to section 10 of the FSS Act, 2006 in respect of functions of the Chief Executive Officer. He then pointed out that under section 22 of the said Act no manufacturers could manufacture products mentioned in the said section. He submitted that Petitioner No.1 was manufacturing the products which have been mentioned in Section 22 of the said Act. He then submitted that section 16(1) of the said Act authorizes the Food Authority to regulate and monitor the activities in respect of manufacture, processing, distribution, sale and import of food products. He submitted that by virtue of the said section, Food Authority had a power to regulate and monitor not only the manufacturing activities but all types of ::: Downloaded on - 13/02/2014 23:11:28 ::: 17 WP2746.13 activities related to food product and, therefore, under the said provision the Food Authority had complete power and jurisdiction to issue such advisories. He then submitted that sub-section (2) of Section 16 clearly stated that without prejudice to the provisions of sub-section (1), the Food Authority may issue Regulations in respect of various items mentioned section 16(2)(a) to 16(2)(i). It is, therefore, submitted that in view of use of the word "may" in sub-
section (2), a discretion is vested in the Food Authority in preparing Regulations, though it is not necessary in view of provisions of section 16(1) which gives complete power and authority to the Food Authority to issue guidelines/regulations to all the manufacturers and food product operators. He submitted that the provisions of section 16(5) of the said Act clearly envisaged that the Food Authority could issue directions to the Commissioner of Food Safety and other authorities which are binding on them. He submitted that, therefore, in view of the said provisions, the Food Authority has the power to issue the impugned advisory.
20. On the other hand, Mr. Chagla, the learned Senior Counsel appearing on behalf of the Petitioners submitted that use of the word "may" in section 16(2) of the FSS Act, 2006 will have to be interpreted as "shall". He submitted that this is abundantly clear on the conjoint reading of ::: Downloaded on - 13/02/2014 23:11:28 ::: 18 WP2746.13 various provisions of the Act and more particularly sections 92 and 93 of the said Act which made it mandatory for the Food Authority to place the said Regulation before both the Houses of the Parliament as envisaged under section 93. It is submitted that so far as section 16(5) is concerned, the said section merely empowers the Food Authority to give directions to the Commissioner of Food. He, however, submitted that these directions could not be outside the purview of the Act and the Rules and Regulations framed thereunder.
21. Taking into consideration the said submissions, therefore, it will be necessary to have a look at the relevant provisions.
22. Section 10 of the said Act reads as follows:-
"10 - Functions of the Chief Executive Officer.-
(1) The Chief Executive Officer shall be the legal representative of the Food Authority and shall be responsible for--
(a) the day-to-day administration of the Food Authority;
(b) drawing up of proposal for the Food Authority's work programmes in consultation with the Central Advisory Committee;
(c) implementing the work programmes and the decisions adopted by the Food Authority;
(d) ensuring the provision of appropriate scientific, technical and administrative support for the Scientific Committee and the Scientific Panel;::: Downloaded on - 13/02/2014 23:11:28 ::: 19
WP2746.13
(e) ensuring that the Food Authority carries out its tasks in accordance with the requirements of its users, in particular with regard to the adequacy of the services provided and the time taken;
(f) the preparation of the statement of revenue and expenditure and the execution of the budget of the Food Authority; and
(g) developing and maintaining contact with the Central Government, and for ensuring a regular dialogue with its relevant committees.
(2) Every year, the Chief Executive Officer shall submit to the Food Authority for approval--
(a) a general report covering all the activities of the Food Authority in the previous year;
(b) programmes of work;
(c) the annual accounts for the previous year; and
(d) the budget for the coming year.
(3) The Chief Executive Officer shall, following adoption by the Food Authority, forward the general report and the programmes to the Central Government and the State Governments and shall have them published.
(4) The Chief Executive Officer shall approve all financial expenditure of the Food Authority and report on the Authority's activities to the Central Government.
(5) The Chief Executive Officer shall exercise the powers of the Commissioner of Food Safety while dealing with matters relating to food safety of such articles.
(6) The Chief Executive Officer shall have administrative control over the officers and other employees of the Food Authority."
Section 16 refers to the duties and functions of the Food Authority. Section 16 of the said Act reads as under:-
::: Downloaded on - 13/02/2014 23:11:28 ::: 20WP2746.13 "16 - Duties and functions of Food Authority.-
(1) 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. (2) Without prejudice to the provisions of sub-section (1), the Food Authority may by regulations specify--
(a) the standards and guidelines in relation to articles of food and specifying an appropriate system for enforcing various standards notified under this Act;
(b) the limits for use of food additives, crop contaminants, pesticide residues, residues of veterinary drugs, heavy metals, processing aids, myco-toxins, antibiotics and pharmacological active substances and irradiation of food;
(c) the mechanisms and guidelines for accreditation of certification bodies businesses;
engaged in certification of food safety management systems for food
(d) the procedure and the enforcement of quality control in relation to any article of food imported into India;
(e) the procedure and guidelines for accreditation of laboratories and notification of the accredited laboratories;
(f) the method of sampling, analysis and exchange of information among enforcement authorities;
(g) conduct survey of enforcement and administration of this Act in the country;
(h) food labelling standards including claims on health, nutrition, special dietary uses and food category systems for foods; and
(i) the manner in which and the procedure subject to which risk analysis, risk assessment, risk communication and risk management shall be undertaken.
(3) The Food Authority shall also--
(a) provide scientific advice and technical support to the Central Government and the State Governments in matters of framing the policy and rules in areas which have a direct or indirect bearing on food safety and nutrition;
(b) search, collect, collate, analyse and summarise relevant scientific and technical data particularly relating to--
(i) food consumption and the exposure of individuals to risks related to the consumption of food;
(ii) incidence and prevalence of biological risk;
(iii) contaminants in food;
(iv) residues of various contaminants;
(v) identification of emerging risks; and ::: Downloaded on - 13/02/2014 23:11:28 ::: 21 WP2746.13
(vi) introduction of rapid alert system;
(c) promote, co-ordinate and issue guidelines for the development of risk assessment methodologies and monitor and conduct and forward messages on the health and nutritional risks of food to the Central Government, State Governments and Commissioners of Food Safety;
(d) provide scientific and technical advice and assistance to the Central Government and the State Governments in implementation of crisis management procedures with regard to food safety and to draw up a general plan for crisis management and work in close co-operation with the crisis unit set up by the Central Government in this regard;
(e) establish a system of network of organisations with the aim to facilitate a scientific co-operation framework by the co-ordination of activities, the exchange of information, the development and implementation of joint projects, the exchange of expertise and best practices in the fields within the Food Authority's responsibility;
(f) provide scientific and technical assistance to the Central Government and the State Governments for improving co-operation with international organisations;
(g) take all such steps to ensure that the public, consumers, interested parties and all levels of panchayats receive rapid, reliable, objective and comprehensive information through appropriate methods and means;
(h) provide, whether within or outside their area, training programmes in food safety and standards for persons who are or intend to become involved in food businesses, whether as food business operators or employees or otherwise;
(i) undertake any other task assigned to it by the Central Government to carry out the objects of this Act;
(j) contribute to the development of international technical standards for food, sanitary and phyto-sanitary standards;
(k) contribute, where relevant and appropriate, to the development of agreement on recognition of the equivalence of specific food related measures;
(l) promote co-ordination of work on food standards undertaken by international governmental and non-governmental organisations;
(m) promote consistency between international technical standards and domestic food standards while ensuring that the level of protection adopted in the country is not reduced; and
(n) promote general awareness as to food safety and food standards. (4) The Food Authority shall make it public without undue delay--
(a) the opinions of the Scientific Committee and the Scientific Panel immediately after adoption;
(b) the annual declarations of interest made by members of the Food Authority, the Chief Executive Officer, members of the Advisory Committee and members of the Scientific Committee and Scientific Panel, as well as the declarations of interest if any, made in relation to items on ::: Downloaded on - 13/02/2014 23:11:28 ::: 22 WP2746.13 the agendas of meetings;
(c) the results of its scientific studies; and
(d) the annual report of its activities.
(5) 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 this Act;
(6) The Food Authority shall not disclose or cause to be disclosed to third parties confidential information that it receives for which confidential treatment has been requested and has been acceded, except for information which must be made public if circumstances so require, in order to protect public health."
The next section of the said Act ig which has been referred to by the learned Counsel appearing on behalf of the Respondents is section 18(1)(a) to section 18(1)(g) and sub-
section (2) of section 18 which read as under:-
"18 - General principles to be followed in administration of Act-
The Central Government, the State Governments, the Food Authority and other agencies, as the case may be, while implementing the provisions of this Act shall be guided by the following principles, namely:--
(1) (a) endeavour to achieve an appropriate level of protection of human life and health and the protection of consumers' interests, including fair practices in all kinds of food trade with reference to food safety standards and practices;
(b) carry out risk management which shall include taking into account the results of risk assessment, and other factors which in the opinion of the Food Authority are relevant to the matter under consideration and where the conditions are relevant, in order to achieve the general objectives of regulations;
(c) where in any specific circumstances, on the basis of assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure appropriate level of health protection may be adopted, pending further scientific information for a more comprehensive risk assessment;
(d) the measures adopted on the basis of clause (c) shall be proportionate and no more restrictive of trade than is required to achieve appropriate ::: Downloaded on - 13/02/2014 23:11:28 ::: 23 WP2746.13 level of health protection, regard being had to technical and economic feasibility and other factors regarded as reasonable and proper in the matter under consideration;
(e) the measures adopted shall be reviewed within a reasonable period of time, depending on the nature of the risk to life or health being identified and the type of scientific information needed to clarify the scientific uncertainty and to conduct a more comprehensive risk assessment;
(f) in cases where there are reasonable grounds to suspect that a food may present a risk for human health, then, depending on the nature, seriousness and extent of that risk, the Food Authority and the Commissioner of Food Safety shall take appropriate steps to inform the general public of the nature of the risk to health, identifying to the fullest extent possible the food or type of food, the risk that it may present, and the measures which are taken or about to be taken to prevent, reduce or eliminate that risk; and
(g) where any food which fails to comply with food safety requirements is part of a batch, lot or consignment of food of the same class or description, it shall be presumed until the contrary is proved, that all of the food in that batch, lot or consignment fails to comply with those requirements.
(2) The Food Authority shall, while framing regulations or specifying standards under this Act--
(a) take into account--
(i) prevalent practices and conditions in the country including agricultural practices and handling, storage and transport conditions;
and
(ii) international standards and practices, where international standards or practices exist or are in the process of being formulated, unless it is of opinion that taking into account of such prevalent practices and conditions or international standards or practices or any particular part thereof would not be an effective or appropriate means for securing the objectives of such regulations or where there is a scientific justification or where they would result in a different level of protection from the one determined as appropriate in the country;
(b) determine food standards on the basis of risk analysis except where it is of opinion that such analysis is not appropriate to the circumstances or the nature of the case;
(c) undertake risk assessment based on the available scientific evidence and in an independent, objective and transparent manner;
(d) ensure that there is open and transparent public consultation, directly or through representative bodies including all levels of panchayats, during the preparation, evaluation and revision of regulations, except where it is of opinion that there is an urgency concerning food safety or public health to make or amend the regulations in which case such consultation may be dispensed with:
Provided that such regulations shall be in force for not more than six months;::: Downloaded on - 13/02/2014 23:11:28 ::: 24
WP2746.13
(e) ensure protection of the interests of consumers and shall provide a basis for consumers to make informed choices in relation to the foods they consume;
(f) ensure prevention of--
(i) fraudulent, deceptive or unfair trade practices which may mislead or harm the consumer; and
(ii) unsafe or contaminated or sub-standard food."
The next relevant section of the said Act is section 22 which reads as under:-
"22 - Genetically modified foods, organic foods, functional foods, proprietary foods, etc-
Save as otherwise provided under this Act and regulations made thereunder, no person shall manufacture, distribute, sell or import any novel food, genetically modified articles of food, irradiated food, organic foods, 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.
Explanation.--For the purposes of this section,--
(1) "foods for special dietary uses or functional foods or nutraceuticals or health supplements" means:
(a) foods which are specially processed or formulated to satisfy particular dietary requirements which exist because of a particular physical or physiological condition or specific diseases and disorders and which are presented as such, wherein the composition of these foodstuffs must differ significantly from the composition of ordinary foods of comparable nature, if such ordinary foods exist, and may contain one or more of the following ingredients, namely:--
(i) plants or botanicals or their parts in the form of powder, concentrate or extract in water, ethyl alcohol or hydro alcoholic extract, single or in combination;
(ii) minerals or vitamins or proteins or metals or their compounds or amino acids (in amounts not exceeding the Recommended Daily Allowance for Indians) or enzymes (within permissible limits);
(iii) substances from animal origin;
(iv) a dietary substance for use by human beings to supplement the diet by increasing the total dietary intake;
(b) (i) a product that is labelled as a "Food for special dietary uses or functional foods or nutraceuticals or health supplements or ::: Downloaded on - 13/02/2014 23:11:28 ::: 25 WP2746.13 similar such foods" which is not represented for use as a conventional food and whereby such products may be formulated in the form of powders, granules, tablets, capsules, liquids, jelly and other dosage forms but not parenterals, and are meant for oral administration;
(ii) such product does not include a drug as defined in clause (b) and ayurvedic, sidha and unani drugs as defined in clauses (a) and
(h) of section 3 of the Drugs and Cosmetics Act, 1940(23 of 1940) and rules made thereunder;
(iii) does not claim to cure or mitigate any specific disease, disorder or condition (except for certain health benefit or such promotion claims) as may be permitted by the regulations made under this Act;
(iv) does not include a narcotic drug or a psychotropic substance as defined in the Schedule of the Narcotic Drugs and Psychotropic Substances Act, 1985(61 of 1985) and rules made thereunder and substances listed in Schedules E and EI of the Drugs and Cosmetics Rules, 1945;
(2) "genetically engineered or modified food" means food and food ingredients composed of or containing genetically modified or engineered organisms obtained through modern biotechnology, or food and food ingredients produced from but not containing genetically modified or engineered organisms obtained through modern biotechnology;
(3) "organic food" means food products that have been produced in accordance with specified organic production standards; (4) "proprietary and novel food" means an article of food for which standards have not been specified but is not unsafe:
Provided that such food does not contain any of the foods and ingredients prohibited under this Act and the regulations made thereunder."
Lastly, section 29 of the said Act reads as under:-
"29 - Authorities responsible for enforcement of Act-
(1) The Food Authority and the State Food Safety Authorities shall be responsible for the enforcement of this Act. (2) The Food Authority and the State Food Safety Authorities shall monitor and verify that the relevant requirements of law are fulfilled by food business operators at all stages of food business.
(3) The authorities shall maintain a system of control and other activities as appropriate to the circumstances, including public communication on food safety and risk, food safety surveillance and other monitoring activities ::: Downloaded on - 13/02/2014 23:11:28 ::: 26 WP2746.13 covering all stages of food business.
(4) The Food Safety Officers shall enforce and execute within their area the provisions of this Act with respect to which the duty is not imposed expressly or by necessary implication on some other authority.
(5) The regulations under this Act shall specify which of the Food Safety Officers are to enforce and execute them, either generally or in relation to cases of a particular description or a particular area, and any such regulations or orders may provide for the giving of assistance and information, by any authority concerned in the administration of the regulations or orders, or of any provisions of this Act, to any other authority so concerned, for the purposes of their respective duties under them. (6) The Commissioner of Food Safety and Designated Officer shall exercise the same powers as are conferred on the Food Safety Officer and follow the same procedure specified in this Act."
23. Before we deal with the said provisions, it will be necessary to also consider the repeal and savings clause in the FSS Act, 2006 under section 97(3). Section 97(3) reads as under:-
"97 - Repeal and savings.-
(1) With effect from such date as the Central Government may appoint in this behalf, the enactment and Orders specified in the Second Schedule shall stand repealed:
Provided that such repeal shall not affect:--
(i) the previous operations of the enactment and Orders under repeal or anything duly done or suffered thereunder; or
(ii) any right, privilege, obligation or liability acquired, accrued or incurred under any of the enactment or Orders under repeal; or
(iii) any penalty, forfeiture or punishment incurred in respect of any offences committed against the enactment and Orders under repeal; or
(iv) any investigation or remedy in respect of any such penalty, forfeiture or punishment, and any such investigation, legal proceedings or remedy may be instituted, continued or enforced and any such penalty, forfeiture or punishment may be imposed, as if this Act had not been passed:
(2) ..............
(3) Notwithstanding the repeal of the aforesaid enactment and Orders, the licences issued under any such enactment or Order, which are in force on the date of commencement of this Act, shall continue to be in force till the date of their expiry for all purposes, as if they had been issued under the ::: Downloaded on - 13/02/2014 23:11:28 ::: 27 WP2746.13 provisions of this Act or the rules or regulations made thereunder.
(4) .........."
Sub-clause (3) of section 97, therefore, clearly saves the licenses which have been issued under the old Act and it clearly states that the said licenses shall continue to be in force till the date of their expiry for all purposes as if they had been issued under the provisions of the said Act and rules and regulations made thereunder.
24. In the present case, Petitioners had obtained license under the old Act. The Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011 have been published in the Gazette of India on 01/08/2011 and, therefore, the said Regulations came into force on the publication of the said Regulations in the Gazette. The said Regulations lay down that the food business operators have to be registered or licensed in accordance with the procedures laid down under the said Regulations. Regulation 2.1.2 is in respect of license for food business. The said Regulation being relevant for deciding the contentions raised in this Petition, it would be profitable to reproduce the said Regulation.
"2.1.2 LICENSES FOR FOOD BUSINESS (1) Subject to Regulation 2.1.1, no person shall commence any food business unless he possesses a valid license. Provided that any person or Food Business Operator carrying on food business on the date of notification of these Regulations, under a license, registration ::: Downloaded on - 13/02/2014 23:11:28 ::: 28 WP2746.13 or permission, as the case may be, under the Acts or Orders mentioned in the Second Schedule of the Act shall get their existing license converted into the license/registration under these regulations by making an application to the Licensing/Registering Authority after complying with the safety requirements mentioned in the Schedule 4 contained under different Parts dependent on nature of business, within one year of notification of these Regulations. In case of difficulty, the licensing authority with the approval of the Food Safety Commissioner in the State will determine the advisability of applying any specific condition keeping in view the need to ensure safety of food and public interest. No license fee will have to be paid for the remaining period of the validity of the earlier license or registration granted under any of the said Acts or Orders.
Non-compliance with this provision by a Food Business Operator will attract penalty under section 55 of the Act. Provided further that any food business operator holding Registration/License under any other Act/Order as specified under schedule 2 of the FSS Act, 2006 with no specific validity or expiry date, and other wise entitled to obtain a license under these regulations, shall have to apply and obtain a Registration/License under these Regulations within one year from the date of notification by paying the applicable fees.
(2) Notwithstanding the provisions contained in Regulation 2.1.2(1) above or in any of the registration or license certificates issued under existing Acts or Orders mentioned in the second schedule of the Act, the Licensing Authority, if it has reason to believe that the Food Business Operator has failed to comply with all or any of the conditions of the existing registration or license or the safety requirements given in Schedule 4, may give appropriate direction to the Food Business Operator to comply with.
(3) License for commencing or carrying on food business, which falls under Schedule 1, shall be granted by the Central Licensing Authority, provided that Food Authority may through notification make such changes or modify the list given in the Schedule I as considered necessary.
(4) License for commencing or carrying on food business, which are not covered under Schedule 1, shall be granted by the concerned State/UT's Licensing Authority.
(5) The Food Business Operator shall ensure that all conditions of license as provided in Annexure 2 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. Provided that the Licensing Authority shall ensure periodical food safety audit and inspection of the licensed establishments through its own or agencies authorized for this purpose by the FSSAI.
Provided further that no person shall manufacture, import, sell, stock, exhibit for distribution or sale any article of food which has been subjected to the treatment of irradiation, except under a license obtained from Department of Atomic Energy under the Atomic Energy (Control of Irradiation of Food) Regulations, 1996."
::: Downloaded on - 13/02/2014 23:11:28 ::: 29WP2746.13 From the aforesaid Regulation, it can be seen that in view of sub-clause (3), license for commencing or carrying on food business which falls under Schedule-1, has to be granted by the Central Licensing Authority. In Schedule-2 of the said Regulations various forms and formats have been mentioned. Form-A is a Form which is to be filled in while applying for Registration/Renewal of Registration under the Food Safety and Standards Act, 2006. Form-B prescribes Application for License/Renewal of license under Food Safety and Standards Act, 2006. Annexure-2 to the said Schedule mentions the documents which are to be enclosed for new application for license to State/Central Licensing Authority and clause (6) mentions the list of food category desired to be manufactured . Clause (8) refers to Analysis report etc. License Format is referred to in Form-C. Form D-1 is the format of Annual Return which has to be submitted by the licensee. The said Regulations practically lay down the entire procedure for the purpose of either obtaining new license or for renewal of license in terms of Regulation 2.1.2 of the said Regulations.
25. Having seen the procedure for obtaining the license, we will have to revert back to the relevant sections reproduced hereinabove to see whether the Food Authority had the power or jurisdiction to issue the impugned advisory dated ::: Downloaded on - 13/02/2014 23:11:29 ::: 30 WP2746.13 11/05/2013.
26. After having perused the aforesaid provisions, in my view, there is no provision in the Act on the basis of which the Food Authority can trace the power to issue the advisory/guidelines/circular which has been challenged in this Petition. The affidavit-in-reply filed by the Respondents does not state that the Food Authority has a power to issue these advisories under section 16(1) of the FSSA, 2006 as has been argued across the bar by the learned Counsel appearing on behalf of the Respondents. The affidavit-in- reply refers to various sections which are reproduced hereinabove and it is stated that on conjoint reading of these sections, it can be seen that the Food Authority could issue these advisories in the interest of public at large.
Since it has been orally argued that section 16(1) gives power to the Food Authority to issue these advisories, it will be necessary to refer to section 16(1) and 16(2). If the language used in section 16(1) is taken into consideration, it is abundantly clear that the power has been given to the Food Authority to regulate and monitor various stages of manufacture, processing, distribution, sale and import of food products. Section 16(2) on the other hand begins with the phrase "Without prejudice to" the provisions of sub- section (1), the Food Authority may make the Regulations in respect of the matters prescribed in section 16(2)(a) to ::: Downloaded on - 13/02/2014 23:11:29 ::: 31 WP2746.13 section 16(2)(i). Here in this case, obviously, the words "Without prejudice to" whatever is stated in susb-section (1) have to be interpreted in the context in which they are used.
It obviously means that while making the Regulations, care should be taken that there is no sub-delegation of power or that power of the Food Authority is not diluted by sub- delegating its power or in other words by keeping the said power which is vested in it intact the Regulations have to be made by the Food Authority. On proper interpretation, therefore, of the said sub-section (2) of section 16, in our view, that by itself does not give an unbridled or unfettered power to the Food Authority to regulate or monitor various activities in food production. It is obvious that the said authority has to be within the power and procedure which is prescribed by the various provisions of the Act. A reference can also be made to the observations of noted Jurist Justice G.P. Singh in his Book Principles of Statutory Interpretation (11th Edition 2008) on page 355, which read as under:-
"........ A provision enacted 'without prejudice' to another provision has not the effect of affecting the operation of the other provision and any action taken under it must not be inconsistent with such provision1 1 ITO v. Gwalior Rayon Silk Manufacturing (Weaving) Co. Ltd, AIR, 1976 SC 43, p.
47........ AIR 2006 SC 1301 (construction of s.56 of FERA which commences with the words 'without prejudice').
::: Downloaded on - 13/02/2014 23:11:29 ::: 32WP2746.13 Section 16(2) on the other hand though mentions that the Food Authority may make Regulations, the said word "may' obviously will have to be interpreted as "shall" in view of the other provisions which are found in the statute viz Sections 92 and 93 of the said Act. The provisions of sections 92 and 93 clearly reveal that the said Regulation has to to be placed before both the Houses of the Parliament and only thereafter it would have statutory force. In this context, again, we can gainfully refer to the observations made by the noted Jurist Justice G.P. Singh in his Book on Principles of Statutory Interpretation (11th Edition, 2008) on page 450 which read as under:-
"The word 'may' may also be used in the sense of 'shall' or 'must' by the Legislature while conferring power of a high dignitary. 1 When the context shows that the power is coupled with an obligation, "the word 'may' which denotes discretion should be construed to mean a command".2 The use of the word 'may' in such cases is "out of deference to the high status of the authority on whom the power and the obligation are 1 State of U.P. Vs Jogendra Singh, AIR, 1963 SC 1618, p.1620:1964(2) SCR 197 2 Ibid: Rangaswami, Textile Commissioner vs. Sagar Textile Mills (P.) Ltd, AIR 1977 SC 1516, p. 1517: (1977) 2 SCC 578 ::: Downloaded on - 13/02/2014 23:11:29 ::: 33 WP2746.13 intended to be conferred and imposed". 1 It was, therefore, held that the words 'the Government may, in respect of a gazetted Government servant on his own request, refer his case to the Tribunal, 'in the context of Rule 4(2) of the U.P. Disciplinary Proceedings (Administrative Tribunal) Rules, 1947, conferred a power coupled with an obligation on the Governor to exercise the power when a request was made by a gazetted Government Servant in that behalf and that the Governor had no discretion in the matter.2 Rule 30 of the Rajasthan Minor Mineral Concession Rules, 1955, which is to the effect that 'a mining lease may be granted for a period of five years unless the applicant himself desires a shorter period', has been construed to confer no discretion on the Government to fix a period less than five years if the applicant did not desire a shorter period."
27. Similarly, the provisions of section 16(5) also do not give any unbridled power to the Food Authority to give any directions to the Commissioner or other authorities. The said 1 State of U.P. vs. Jogendra Singh, AIR 1963 SC 1618, p.1620 : 1964 (2) SCR 197. 2 Ibid ::: Downloaded on - 13/02/2014 23:11:29 ::: 34 WP2746.13 directions, therefore, have to be within the framework of law enacted by the Parliament and the Rules and Regulations framed thereunder. From the aforesaid provisions, therefore, it is clear that it is open for the Food Authority to issue guidelines or advisories which are within the framework of the law and these advisories or Regulations, in order to have force of law, have to be approved by both the Houses of Parliament.
28. In the present guidelines/circular/advisory case, perusal reveals that of the procedure said of product approval as envisaged in the said advisory does not find place at least in respect of existing manufacturers and in respect of the products which are already in the market. If the Food Authority or any of its Officers find that the general standards which are mentioned in various Regulations are not followed, it is always open for the Food Authority to take various steps as envisaged under the provisions of the Act and Regulations either (a) for issuing the prohibitory order for recalling the food products (b) for cancellation/suspension of license or (b) for launching a prosecution and taking other steps in order to ensure that the food which is manufactured, supplied and distributed by such manufacturers is wholesome food and is safe for the public consumption. Though a query was made by this Court as to whether the said advisory was issued only in respect of new products ::: Downloaded on - 13/02/2014 23:11:29 ::: 35 WP2746.13 which were to be introduced in market for the first time, the learned Counsel appearing on behalf of the Food Authority vehemently argued that all the manufacturers including existing manufacturers of all the products would have to apply for product approval in respect of the items which are mentioned in Schedule-1 of the Regulations.
29. In my view, there is much substance in the submissions made by the learned Senior Counsel appearing on behalf of the Petitioners. So far as the judgment on which reliance is placed in the affidavit-in-reply is concerned, the ratio of the said judgment will not apply to the facts of the present case. The aforesaid decision relates to the dispute concerning fixation of tariff by the Commission pursuant to the express power conferred on such Commission under the Adhra Pradesh Electricity Reforms Act (30 of 1998). In the facts of that case, the Apex court has affirmed the view taken by the High Court that regulatory Commission had fixed tariff in accordance with the provisions of the said Act. In the present case, however, the impugned advisories have been issued without complying with the mandatory provisions of the Act and whenever it is found that the decision has been taken without following the proper procedure and is contrary to the provisions of the Act, Courts have full power to interfere with such decisions. The said principle is quite well settled and it is not necessary to refer to various judgments ::: Downloaded on - 13/02/2014 23:11:29 ::: 36 WP2746.13 of the Apex Court. When a statutory authority is required to do a thing in a manner provided under the statute, the same must be done in that manner or not at all.
30. In this context it will be relevant to refer to Treaties on Administrative Law by H.W.R. Wade & C.F. Forsyth in Part V wherein it is observed as under:-
SURRENDER, ABDICATION, DICTATION Closely akin Power in the wrong hands to delegation and scarcely distinguishable from it in some cases, is any arrangement by which a power conferred upon one authority is in substance exercised by another. The proper authority may share its power with someone else, or may allow someone else to dictate to it by declining to act without their consent or by submitting to their wishes or instructions. The effect then is that the discretion conferred by Parliament is exercised, at least in part, by the wrong authority, and the resulting decision is ultra vires and void. So strict are the courts in applying this principle that they condemn some administrative arrangements which must seem quite natural and proper to those who make them......."::: Downloaded on - 13/02/2014 23:11:29 ::: 37
WP2746.13 Similarly, in the same Text, on the concept of delegated legislation particularly issuance of departmental circulars, the author has quoted paragraph from the judgment of Streatfield J.
"........ A judgment notable for its forceful language, as well as for its awareness of the wide constitutional implications, was delivered by Scott LJ who had formerly been chairman of the Committee on Minsiters' Powers and was inclined to deplore the failure to implement its report. He described some of the events as 'an example of the very worst kind of bureaucracy'. But the root of the trouble may well have been the difficulty of telling where legislation began and ended.
In a case of the same kind, where the requisition was held invalid for non-observance of the condition in the circular requiring notice to be given to the owner, Streatfield J said:
"Whereas ordinary legislation, by passing through both Houses of Parliament or, at least, lying on the table of both Houses, is thus twice based, this type of so-called legislation is at least four times cursed. First, it has seen neither House of Parliament; secondly, it is unpublished and is inaccessible even ::: Downloaded on - 13/02/2014 23:11:29 ::: 38 WP2746.13 to those whose valuable rights of property may be affected; thirdly, it is jumble of provisions, legislative, administrative, or directive in character, an sometimes difficult to disentangle one from the other; and, fourthly, it is expressed not in the precise language of an Act of Parliament or an Order in Council but in the more colloquial language of correspondence, which is not always susceptible of the ordinary cannons of construction."
In my view, present advisory goes beyond the scope of the Act and is contrary to the provisions of the Act itself since the process of product approval at least of old existing products which are in the market for decades is not envisaged under the Act and contention of Respondent No.2 that introduction of product approval is consistent with section 18 is misconceived. The impugned advisory instead of clarifying the Regulations has widened and overreached the scope of the Act and the Rules and Regulations framed thereunder. Even the power conferred by section 16(5) is restricted to the issuance of directions within the framework of the Act and such directions cannot exceed the scope of the Act or its purpose as provided under section 16(5).
31. After the old Act was repealed, existing licenses were ::: Downloaded on - 13/02/2014 23:11:29 ::: 39 WP2746.13 saved and by virtue of the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011, any person or Food Business Operator carrying on food business on the date of notification of these Regulations, under a license, registration or permission, as the case may be, under the Acts or Orders mentioned in the Second Schedule of the Act shall get their existing license converted into the license/registration under these regulations by making an application to the Licensing/Registering Authority under the said Regulation No.2.1.2. The form in which the said application is to be made has been specified in the forms which are annexed to the said Regulation of 2011. Perusal of these forms and the forms which are now annexed to the impugned advisory will reveal that several new factors have now been introduced bye-passing the Regulations which have approved the format in the Schedule annexed to the Regulations.
32. Apart from that, the said Advisory also requires the applicants to fill in the affidavit in the format which is prescribed in the advisory which is not contemplated even under the Regulations which have been approved by placing them before both the Houses of Parliament. If the Food Authority is permitted to carry out the exercise which is devised by the Authority, it would result in a chaotic situation where all the existing manufacturers who had valid license ::: Downloaded on - 13/02/2014 23:11:29 ::: 40 WP2746.13 for several decades will now be required under the garb of this advisory to obtain product approval even in respect of the existing products and till such time the product approval is not granted, they would be precluded from marketing the said products which have been in the market for sufficiently long time. Of course, it does not mean that the Food Authority does not have power to regulate/monitor the process of manufacture, distribution, sale etc and if it finds that certain products, after analysis, do not conform to the international standards or other standards which are to be found in sections 18 and 22, it can always take action which is permitted under the various provisions of the Act in order to ensure that such food items which are unsafe for human consumption are removed from the market. The main purpose of bringing this new Act into force was not only to effectively fix the food standards and to monitor them but also to ensure that rigid and non-responsive standards were required to be changed so that the food processing industry would not be faced with several difficulties.
FINDINGS:
33. In view of the aforesaid reasons, in my view, therefore, the said advisory so far as it makes compulsory even to existing manufacturers to obtain product approval before obtaining the license under Regulation 2.1.2 of the said ::: Downloaded on - 13/02/2014 23:11:29 ::: 41 WP2746.13 Regulations, 2011 is, therefore, ultra vires the provisions of the Act and the Rules and Regulations framed thereunder and, therefore, in my view, the Food Authority cannot issue such Advisories which are contrary to the provisions of the Act and the Rules and Regulations framed thereunder unless they are approved as per the provisions of sections 92 and
93.
34. It is clarified that the Food Authority can issue such Advisories which are within the confinement of the provisions of the FSS Act, 2006 and the Rules and Regulations framed thereunder.
35. In my view, this Petition will have to be allowed and is allowed. The impugned advisory dated 11/05/2013 so far as it relates to existing manufacturers who had licenses and registration prior to the present FSS Act, 2006 and Regulations of 2011 coming into force, are quashed and set aside.
(V.M. KANADE, J.)
36. At this stage, my learned brother Girish S. Kulkarni, J. expressed that he is unable to agree with the view taken by me and, therefore, he would like to give a differing judgment. He, however, needs some more time to deliver a differing judgment.
::: Downloaded on - 13/02/2014 23:11:29 ::: 42WP2746.13
37. Stand over for one week in order to enable my learned brother Girish S. Kulkarni, J. to deliver a differing judgment.
(GIRISH S. KULKARNI, J. ) (V.M. KANADE, J.) ORAL JUDGMENT: Per G.S.KULKARNI, J. (dissenting) Reserved on 28th January, 2014 Pronounced on 4th February, 2014
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 ::: Downloaded on - 13/02/2014 23:11:29 ::: 43 WP2746.13 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) ::: Downloaded on - 13/02/2014 23:11:29 ::: 44 WP2746.13 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 ::: Downloaded on - 13/02/2014 23:11:29 ::: 45 WP2746.13 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 ::: Downloaded on - 13/02/2014 23:11:29 ::: 46 WP2746.13 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 relating to food and to provide for a systematic and scientific development of Food Processing Industries. That it was proposed to establish the Food Safety and Standards Authority of India, which will fix food standards and regulate/monitor the manufacturing, import, processing, distribution and sale of food, so as to ensure safe and wholesome food for the people. That the Food Authority will be assisted by Scientific Committees and Panels in fixing standards and by a Central Advisory Committee in prioritization of the work. Thus, the main features of the Bill as enumerated in paragraph (5) and (6) of the Statement of Objects and Reasons are as follows:-
"5. The Bill, inter alia, incorporates the salient provisions of the Prevention of Food Adulteration Act,1954 (37 of 1954) and is based on international legislations, instrumentalities and Codex Alimentaries Commission (which related to food safety norms). In a nutshell, the Bill takes care of International practices and invisages on overarching policy framework and provision of single ::: Downloaded on - 13/02/2014 23:11:29 ::: 47 WP2746.13 window to guide and regulate persons engaged in manufacture, marketing, processing, handling, transportation, import and sale of food. The main features of the Bill are:
(a) movement from multi-level and multi-
departmental control to integrated line of command;
(b) integrated response to strategic issues like noval/ genetically modified foods, international trade;
(c) licensing for manufacture of food products, which is presently granted by the Central Agencies under various Acts and Orders, would stand decentralized to the Commissioner of Food Safety and his officer;
(d) single reference point for all matters relating to Food Safety and Standards, regulations and enforcement;
(e) shift from mere regulatory regime to self compliance through Food Safety Management Systems;
(f) responsibility on food business operators to ensure that food processed, manufactured, imported or distributed is in compliance with the domestic food laws; and
(g) provision for graded penalties depending on the gravity of offence and accordingly, civil penalties for minor offences and punishment for serious violations.
The abovesaid Bill is contemporary, comprehensive and intends to ensure better consumer safety through Food Safety Management Systems and setting standards based on science and transparency as also to meet the dynamic requirements of Indian Food Trade and Industry and International trade."::: Downloaded on - 13/02/2014 23:11:29 ::: 48
WP2746.13 Scheme of the FSS Act,2006.
6. On the aforesaid legislative background FSS Act,2006 was enacted and was brought into force at different dates as provided for in sub-section (3) of Section 1 which reads as under:-
1. Short title, extent and commencement-(3)
It shall come into force on such date as the Central Government may, by notification in the Official Gazette, appoint, and different dates may be appointed for different provisions of this Act and any reference in any such provision to the commencement of this Act shall be construed as a reference to the coming into force of that provision."
The provisions of Sections 16 and 18 (both inclusive), and the provisions of Section 81 to 86, 92 and 93 were brought into force on 18.11.2008.
7. Some of the provisions which are necessary to decide the moot issue in the present petition are reproduced ::: Downloaded on - 13/02/2014 23:11:30 ::: 49 WP2746.13 hereinbelow for the sake of convenience.
Section 3. Definitions - (1) In this Act, unless the context otherwise requires,-
--- --- --- --- --- ---
(j) "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 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"
Provided that 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;
(m) "Food Authority" means the Food Safety and Standards Authority of India established under section 4;
(n) "food business" means 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;
(o) "food business operator" in relation to food business means 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;::: Downloaded on - 13/02/2014 23:11:30 ::: 50
WP2746.13
(q) "food safety" means assurance that food is acceptable for human consumption according to its intended use;
(zc) "manufacture" means 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;
(zd) "manufacturer" means 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;
(zg) "notification" means a notification published in the Official Gasette;
(zj) "prescribed" means prescribed by rules made by the Central Government or the State Government, as the case be under this Act;
(zo) "risk assessment" means a scientifically based process consisting of the following steps: (I) hazard identification, (ii) hazard characterisation, (iii) exposure assessment, and (iv) risk characterisation;
(zu) "standard", in relation to any article of food, means the standards notified by the Food Authority;
(zz) "unsafe food" means an article of food whose nature, 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 ::: Downloaded on - 13/02/2014 23:11:30 ::: 51 WP2746.13 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, favoured 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 ig (xi) by virtue of its being mis-branded or sub-standard or food containing extraneous matter; or
(xii) by virtue of containing pesticides and other contaminants in excess of quantities specified by regulations."
The extensive nature of the definition clause indicates the various aspects with which the Act deals with the sole object to interalia ensure safety of food for human consumption.
8. Section 4 of FSS Act provides for establishment of Food Safety and Standard Authority of India (hereinafter referred to as "the Food Authority") which is impleaded as Respondent no.2 in the present petition. Sections 5 to 9 of ::: Downloaded on - 13/02/2014 23:11:30 ::: 52 WP2746.13 the FSS Act pertains to the composition of Food Authority and various aspects concerning its working. Section 10 for which reference attributed on behalf of respondent no.2 pertains to functions of the Chief Executive Officer which who shall be legal representative of the Food Authority responsible for day to day administration of Food Authority and it is his duty under the said provision to implement the work programme and the decisions adopted by the Food Authority and to inter alia ensure that the provision of appropriate scientific, technical and administrative support for the scientific committee and specific panel, and that of ensuring that the Food Authority carries out its task and in accordance with the requirements of its users in particular with regard to the adequacy of service provided and the time taken etc. Section 11 provides for establishment of Central Advisory Committee by the Food Authority. Section 12 provides for functions of Central Advisory Committee. Section 13 provides for scientific panels to be established by the Food Authority. Section 14 provides for Scientific Committee to be constituted by the Food Authority. Section 15 provides for ::: Downloaded on - 13/02/2014 23:11:30 ::: 53 WP2746.13 procedure for Scientific Committee and Scientific Panel. All these provisions show the different wings under which the Food Authority would function to attain the object of laying down science based standards for articles of foods and for regulating the manufacture and other incidental matters to ensure availability of safe and wholesome food for human being. Section 16 of the FSS Act provides for duties and functions of the Food Authority.
9. The provisions of Section 16, 18 and 22 on which much deliberation has taken place in the context of the present dispute are reproduced hereinbelow for the sake of convenience:-
"16. Duties and functions of Food Authority.
(1) 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.
(2) Without prejudice to the provisions of sub-section (1),the Food Authority may by regulations specify -
(a) the standards and guidelines in relation to articles of food and specifying an appropriate system for enforcing various standards notified under this Act;
(b) the limits for use of food additives, crop contaminants, pesticide residues, residues of veterinary drugs, heavy metals, processing aids, myco-toxins, antibiotics and pharmacological active substances and irradiation of food;::: Downloaded on - 13/02/2014 23:11:30 ::: 54
WP2746.13
(c) the mechanisms and guidelines for accreditation of certification bodies engaged in certification of food safety management systems for food businesses;
(d) the procedure and the enforcement of quality control in relation to any article of food imported into India;
(e) the procedure and guidelines for accreditation of laboratories and notification of the accredited laboratories;
(f) the method of sampling, analysis and exchange of information among enforcement authorities;
(g) conduct survey of enforcement and administration of this Act in the country;
(h) food labelling standards including claims on health, nutrition, special dietary uses and food category systems for foods; and
(i) the manner in which and the procedure subject to which risk analysis, risk assessment, risk communication and risk management shall be undertaken.
(3) The Food Authority shall also -
(a) provide scientific advice and technical support to the Central Government and the State Governments in matters of framing the policy and rules in areas which have a direct or indirect bearing on food safety and nutrition;
(b) search, collect, collate, analyse and summarise relevant scientific and technical data particularly relating to -
(i) food consumption and the exposure of individuals to risks related to the consumption of food;
(ii) incidence and prevalence of biological risk;
(iii) contaminants in food;
(iv) residues of various contaminants;
(v) identification of emerging risks; and
(vi) introduction of rapid alert system;
(c) promote, co-ordinate and issue guidelines for the development ::: Downloaded on - 13/02/2014 23:11:30 ::: 55 WP2746.13 of risk assessment methodologies and monitor and conduct and forward messages on the health and nutritional risks of food to the Central Government, State Governments and Commissioners of Food Safety;
(d) provide scientific and technical advice and assistance to the Central Government and the State Governments in implementation of crisis management procedures with regard to food safety and to draw up a general plan for crisis management and work in close co-operation with the crisis unit set up by the Central Government in this regard;
(e) establish a system of network of organisations with the aim to facilitate a scientific co-operation framework by the co-ordination of activities, the exchange of information, the development and implementation of joint projects, the exchange of expertise and best practices in the fields within the Food Authority's responsibility;
(f) provide scientific and technical assistance to the Central Government and the State Governments for improving co- operation with international organisations;
(g) take all such steps to ensure that the public, consumers, interested parties and all levels of panchayats receive rapid, reliable, objective and comprehensive information through appropriate methods and means;
(h) provide, whether within or outside their area, training programmes in food safety and standards for persons who are or intend to become involved in food businesses, whether as food business operators or employees or otherwise;
(i) undertake any other task assigned to it by the Central Government to carry out the objects of this Act;
(j) contribute to the development of international technical standards for food, sanitary and phyto-sanitary standards;
(k) contribute, where relevant and appropriate to the development of agreement on recognition of the equivalence of specific food related measures;
(l) promote co-ordination of work on food standards undertaken by international governmental and nongovernmental organisations;
(m) promote consistency between international technical standards and domestic food standards while ensuring that the level of ::: Downloaded on - 13/02/2014 23:11:30 ::: 56 WP2746.13 protection adopted in the country is not reduced; and
(n) promote general awareness as to food safety and food standards.
(4) The Food Authority shall make it public without undue delay-
(a) the opinions of the Scientific Committee and the Scientific Panel immediately after adoption;
(b) the annual declarations of interest made by members of the Food Authority, the Chief Executive Officer, members of the Advisory Committee and members of the Scientific Committee and Scientific Panel, as well as the declarations of interest if any, made in relation to items on the agendas of meetings;
(c) the results of its scientific studies; and
(d) the annual report of its activities;
(5) 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 this Act;
(6) The Food Authority shall not disclose or cause to be disclosed to third parties confidential information that it receives for which confidential treatment has been requested and has been acceded, except for information which must be made public if circumstances so require, in order to protect public health.
(emphasis supplied) Section 18. General principles to be followed in Administration of Act.
The Central Government, the State Governments, the Food Authority and other agencies, as the case may be, while implementing the provisions of this Act shall be guided by the following principles namely:-
(1) (a) endeavour to achieve an appropriate level of protection of human life and health and the protection of consumer's interests, including fair practices in all kinds of food trade with reference to food safety standards and practices;
(b) carry out risk management which shall include taking into account the results of risk assessment and other factors which in the opinion of the Food Authority are relevant to the matter under consideration and where the conditions are relevant, in order to ::: Downloaded on - 13/02/2014 23:11:30 ::: 57 WP2746.13 achieve the general objectives of regulations;
(c) where in any specific circumstances, on the basis of assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure appropriate level of health protection may be adopted, pending further scientific information for a more comprehensive risk assessment;
(d) the measures adopted on the basis of clause (c) shall be proportionate and no more restrictive of trade than is required to achieve appropriate level of health protection, regard being had to technical and economic feasibility and other factors regarded as reasonable and proper in the matter under consideration;
(e) The measures adopted shall be reviewed within a reasonable period of time, depending on the nature of the risk to life or health being identified and the type of scientific information needed to clarify the scientific uncertainty and to conduct a more comprehensive risk assessment;
(f) in cases where there are reasonable grounds to suspect that a food may present a risk for human health, then, depending on the nature, seriousness and extent of that risk, the Food Authority and the Commissioner of Food Safety shall take appropriate steps to inform the general public of the nature of the risk to health, identifying to the fullest extent possible the food or type of food, the risk that it may present, and the measures which are taken or about to be taken to prevent, reduce or eliminate that risk; and
(g) where any food which fails to comply with food safety requirements is part of a batch, lot or consignment of food of the same class or description, it shall be presumed until the contrary is proved, that all of the food in that batch, lot or consignment fails to comply with those requirements.
(2) The Food Authority shall, while framing regulations or specifying standards under this Act-
(a) take into account -
(i) prevalent practices and conditions in the country including agricultural practices and handling, storage and transport conditions; and
(ii) international standards and practices, where international standards or practices exist or are in the process of being formulated, unless it is of opinion that taking into account of such ::: Downloaded on - 13/02/2014 23:11:30 ::: 58 WP2746.13 prevalent practices and conditions or international standards or practices or any particular part thereof would not be an effective or appropriate means for securing the objectives of such regulations or where there is a scientific justification or where they would result in a different level of protection from the one determined as appropriate in the country;
(b) determine food standards on the basis of risk analysis except where it is of opinion that such analysis is not appropriate to the circumstances or the nature of the case;
(c) undertake risk assessment based on the available scientific evidence and in an independent, objective and transparent manner;
(d) ensure that there is open and transparent public consultation, directly or through representative bodies including all levels of panchayats, during the preparation, evaluation and revision of regulations, except where it is of opinion that there is an urgency concerning food safety or public health to make or amend the regulations in which case such consultation may be dispensed with :
Provided that such regulations shall be in force for not more than six months;
(e) ensure protection of the interests of consumers and shall provide a basis for consumers to make informed choices in relation to the foods they consume;
(f) ensure prevention of -
(i) fraudulent, deceptive or unfair trade practices which may mislead or harm the consumer; and
(ii) unsafe or contaminated or sub-standard food.
(3) The provisions of this 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 or products of crops produced by a farmer at farm level or a fisherman in his operations. (emphasis supplied) Section 22. Genetically modified foods, organic foods, functional foods, proprietary foods, etc :
Save as otherwise provided under this Act and regulations made thereunder, no person shall manufacture, distribute, sell or import any novel food, genetically modified articles of food, ::: Downloaded on - 13/02/2014 23:11:30 ::: 59 WP2746.13 irradiated food, organic foods, 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.
Explanation.- For the purposes of this section,-
(1) "foods for special dietary uses or functional foods or nutraceuticals or health supplements" means:
(a) foods which are specially processed or formulated to satisfy particular dietary requirements which exist because of a particular physical or physiological condition or specific diseases and disorders and which are presented as such, wherein the composition of these foodstuffs must differ significantly from the composition of ordinary foods of comparable nature, if such ordinary foods exist, and may contain one or more of the following ingredients, namely:-
(i) plants or botanicals or their parts in the form of powder, concentrate or extract in water, ethyl alcohol or hydro alcoholic extract, single or in combination;
(ii) minerals or vitamins or proteins or metals or their compounds or amino acids (in amounts not exceeding the Recommended Daily Allowance for Indians) or enzymes (within permissible limits);
(iii) substances from animal origin;
(iv) a dietary substance for use by human beings to supplement the diet by increasing the total dietary intake;
(b) (i) a product that is labelled as a "Food for special dietary uses or functional foods or nutraceuticals or health supplements or similar such foods" which is not represented for use as a conventional food and whereby such products may be formulated in the form of powders, granules, tablets, capsules, liquids, jelly and other dosage forms but not parenterals, and are meant for oral administration;
(ii) such product does not include a drug as defined in clause (b) and ayurvedic, sidha and unani drugs as defined in clauses (a) and
(h) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and rules made thereunder;
(iii) does not claim to cure or mitigate any specific disease, disorder or condition (except for certain health benefit or such promotion claims) as may be permitted by the regulations made under this Act;::: Downloaded on - 13/02/2014 23:11:30 ::: 60
WP2746.13
(iv) does not include a narcotic drug or a psychotropic substance as defined in the Schedule of the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985) and rules made thereunder and substances listed in Schedules E and EI of the Drugs and Cosmetics Rules, 1945;
(2) "genetically engineered or modified food" means food and food ingredients composed of or containing genetically modified or engineered organisms obtained through modern biotechnology, or food and food ingredients produced from but not containing genetically modified or engineered organisms obtained through modern biotechnology;
(3) "organic food" means food products that have been produced in accordance with specified organic production standards;
(4) "proprietary and novel food" means an article of food for which standards have not been specified but is not unsafe:
Provided that such food does not contain any of the foods and ingredients prohibited under this Act and regulations made thereunder. (emphasis supplied) Chapter V of the FSS Act pertains to the provisions in relation to food import. Chapter VI of the FSS Act pertains to special responsibilities as to food safety under which Section 26 provides for responsibilities of the Food Business Operator. Chapter VIII provides for enforcement of the Act, under which Section 29 provides that the Food Safety and State Food Safety Authorities who shall be responsible for enforcement of the Act.
10. Section 31 provides for licensing and registration of ::: Downloaded on - 13/02/2014 23:11:30 ::: 61 WP2746.13 food business and stipulates that no person shall commence or carry on any food business except under a licence. Sub-
section (2) of Section 31 exempts a petty manufacturer who himself manufactures or sells any article of food or a petty retailer, hawker, itinerant vendor or a temporary stall holder or small scale or cottage or such other industries relating to food business or tiny food business operator. However, it provides that they shall register themselves with such authority and in such manner as may be specified by Regulations, without prejudice to the availability of safe and wholesome food for human consumption or affecting the health of the consumers. Sub-section (3) of this section provides that any person desirous to commence or carry on any food business shall make an application for grant of a license to the Designated Officer in such manner containing such particulars and fees as may be specified by regulations.
Sub-section 4 provides that the Designated Officer on receipt of an application under sub-section (3), may either grant the license or after giving the applicant an opportunity of being heard and for reasons to be recorded in writing, refuse to ::: Downloaded on - 13/02/2014 23:11:30 ::: 62 WP2746.13 grant a license to any applicant, if he is satisfied that it is necessary so to do in the interest of public health and shall make available to the applicant a copy of the order. Proviso to sub-section (4) stipulates that if a license is not issued within two months from the date of making the application or his application is not rejected, the applicant may start his food business after expiry of the said period and in such a case, the Designated Officer shall not refuse to issue a license but may, if he considers necessary, issue an improvement notice, under section 32 and follow procedures in that regard. Sub-Section 8 of Section 31 provides for an appeal against the order of rejection for the grant of license which shall lie to the Commissioner of Food Safety. Proviso to sub-section 9 stipulates that if an application for renewal of a license is made before the expiry of the period of validity of the license, the license shall continue to be in force until orders are passed on the application.
11. Section 91 provides for the powers of the Central Government to make rules inter-alia on the various matters ::: Downloaded on - 13/02/2014 23:11:30 ::: 63 WP2746.13 which are provided under sub-section 2 of the said provision.
Section 92 of FSS Act provides for power of the Food Authority to make regulations inter-alia on the matters which are provided under sub-section 2 which enumerates under clauses (a) to (v) of sub-section (2) to notify standards and guidelines in relation to articles of food meant for human consumption, under sub-section (2) of Section 16. Section 93 provides for laying down rules and regulations before Parliament. Section 97 is the repeal and saving clause. Sub-
section (3) of Section 97 provides that notwithstanding the repeal of the aforesaid enactment and orders, the licenses issued under any such enactment or order, which are in force on the date of commencement of the FSS Act, shall continue to be in force till the date of their expiry for all purposes, as if they had been issued under the provisions of the FSS Act or the rules or regulations made thereunder.
12. In exercise of powers conferred by Clause (e) of sub-section (2) of Section 92 read with Section 16 FSS Act, the Food Authority has made the Food Safety and Standard ::: Downloaded on - 13/02/2014 23:11:30 ::: 64 WP2746.13 (Food Products Standards and Food Additives) Regulations,2011 (hereinafter referred to as "the Food Products Standard Regulations"). These regulations have come into force on 5.8.2011 except certain regulations as mentioned in Regulation 1.1.2 which are notified to come into force after six months from 5.8.2011. The proviso to Regulation 1.1.2 stipulates that whenever the standards given in these regulations are at variance with any of the provisions of the licenses already granted, Food Business Operator shall comply with the provisions of these regulations within six months from the date of commencement of these regulations. These regulations extensively deal with safety aspect in relation to food and food products standards.
13. Further, the Food Authority in exercise of the powers conferred under Clause (o) of sub-section (2) of Section 92 read with Section 31 of the FSS Act has made the Food Safety Standards (Licensing & Registration of Food Business) Regulations,2011. These regulations are brought into force on 5.8.2011 and inter alia provide for various matters in regard to the licensing and registration of food business (hereinafter referred to as "the Licensing and Registration Regulations"). Regulation 2.1 provides for ::: Downloaded on - 13/02/2014 23:11:30 ::: 65 WP2746.13 registration and licensing of food business. Regulation 2.1.1 provides for registration of petty food business. Regulation 2.1.2 provides for licence for food business and stipulates that subject to Regulation 2.1.1 no person shall commence any food business unless he possesses a valid license. It further provides that any person or Food Business Operator carrying on food business on the date of notification of these Regulations, under a license, registration or permission, as the case may be, under the Act or Orders mentioned in the Second Schedule of the Act shall get their existing license converted into the license/registration under these regulations by making an application to the Licensing/Registering Authority after complying with the safety requirements mentioned in the Schedule 4 dependent on nature of business, within one year of the notification of Licensing and Registration Regulations. It provides that in case of difficulty, the licensing authority with the approval of the Food Safety Commissioner in the State will determine the advisability of applying any specific condition keeping in view the need to ensure safety of food and public interest. It further provides that no license fee will have to be paid for the remaining period of the validity of the earlier license or registration granted under any of the said Acts or Orders. It further provides that non-compliance with this provision by a Food Business Operator will attract penalty under section 55 of the Act. In the proviso to the said Regulation, it is stipulated that any food business operator holding ::: Downloaded on - 13/02/2014 23:11:30 ::: 66 WP2746.13 Registration/License under any other Act/Order as specified under Second schedule of the FSS Act, 2006 with no specific validity or expiry date, and otherwise entitled to obtain a license under these regulations, shall have to apply and obtain a Registration/License under these Regulations within one year from the date of notification by paying the applicable fees. Sub-clause (2) of Regulation 2.1.2 provides that notwithstanding the provisions contained in Regulation 2.1.2(1) or in any of the registration or license certificates issued under existing Acts or Orders mentioned in the second schedule of the Act, the Licensing Authority, if it has reason to believe that the Food Business Operator has failed to comply with all or any of the conditions of the existing registration or license or the safety requirements given in Schedule 4, may give appropriate direction to the Food Business Operator to comply with the said requirements. Sub-regulation (3) of Regulation 2.1.2 provides that License for commencing or carrying on food business, which falls under Schedule 1, shall be granted by the Central Licensing Authority, provided that Food Authority may through notification make such changes or modify the list given in the Schedule I as considered necessary. Sub-regulation (4) of this Regulation provides that License for commencing or carrying on food business, which are not covered under Schedule 1, shall be granted by the concerned State/UT's Licensing Authority. Schedule 1 which concerns with Regulation 2.1.2 (3) provides for ::: Downloaded on - 13/02/2014 23:11:30 ::: 67 WP2746.13 list of businesses falling under the purview of Central Licensing Authority.
Item VIII of this Schedule concerns all food business operators manufacturing any article of food containing ingredients or substances or using technologies or processes or combination thereof whose safety has not been established through these regulations or which do not have a history of safe use or food containing ingredients which are being introduced for the first time into the country.
14. The Food Authority in exercise of powers conferred under clause (k) of Sub-section (2) of Section 92 read with Section 23 of FSS Act has also made Food Safety and Standards (Packaging and Labelling) Regulations,2011, which inter alia provide for various matters pertaining to packaging and labelling of food products.
15. After considering the aforesaid scheme of the FSS Act and the Regulations framed thereunder, it is necessary to refer to the various actions which the Food Authority has taken under the FSS Act. The Food Authority from time to time has issued various "advisories" in respect of different food products. These advisories are annexed to the writ petition. It would be relevant to mention about the nature of the said advisories issued from time to time so as to appreciate the concern of the Food Authority. Briefly the ::: Downloaded on - 13/02/2014 23:11:30 ::: 68 WP2746.13 advisories are issued on the following issues:-
(I) Advisory on the products containing Steroid/ steroid like substances marketed as dietary supplement, which inter alia states that steroid containing products present a risk of acute liver injury to product users. In addition, steroids may cause other serious long-term adverse health consequences in people including children. These may include male infertility, masculinisation of women, breast enlargement in males, short stature in children, adverse effects on blood lipid profile and increased risk of heart attack and stroke and death. It is stated that general public is advised to understand the risk involved in usage of such products and refrain from using such products. A list of such 65 products is annexed to the said advisory.
(II) Advisory on standards for honey and prohibition of antibiotics.
(III) Advisory on Chemicals present in fruits and vegetables and their health effects.
(IV) Advisory on sale of contaminated milk in the country.
(V) Advisory on ban on import of diary products from China.
(VI) Advisory on misbranding/misleading claims.
(VII) Advisory on issue of licensing of milk and milk products.
(VIII) Advisory on refused gelatine contaminated with clostridium difficile from US FDA.::: Downloaded on - 13/02/2014 23:11:30 ::: 69
WP2746.13 (IX) Advisory on iron fillings in tea.
(X) Advisory on use of stearic acid as lubricant in sugar based/ sugar free confectionery, lozenges and chewing gum/ bubble gum.
(XI) Advisory on licensing/Registration of Alcoholic Drinks.
(XII) Advisory on outbreak of salmonellosis in the USA and New Zealand linked to Tahini Sesame Paste from Turkey;
(XIII) Advisory on use of glazing agents Shellac, Beeswax (white and yellow), gum arabic and pectin in chocolates at GMP level.
(XIV) Advisory on the procedure adopted by Food Authority for approval of proprietary products/ ingredients already being manufactured under licenses of erstwhile Acts/Orders. dated 22.3.2012.
16. Apart from specific advisories issued in respect of different food products, the Food Authority had issued the following advisories:-
Sr.no Date Subject of Advisories
1. Advisory regarding renewal/transfer of
licence during transition period
2. 5.7.2011 Appointment of food Inspectors
employed by the Municipal
Corporations/Councils, as the Food
Safety Officer and Designated officer
under the provisions of Food Safety &
3. 1.3.2012 Standards Act,2006.
::: Downloaded on - 13/02/2014 23:11:30 :::
70
WP2746.13
Issue of licensing of FBO at Airports &
4. 24.1.2012 Ports
5. 23.3.2012 Issue of State/Central Licensing -
Clarification on jurisdiction.
6. 2.4.2012 Guidelines related to Food Import
Clearance Process by FSSAI's
authorized officers.
FSMS Plan/Certificates
It may be mentioned that no dispute has been raised by the Petitioners on the aforesaid advisories.
17. However, the area of dispute is on the advisories on "Product Approval". The following are the advisories issued by the Food Authority in regard to the "Product Approval":-
(I) Advisory dated 23.4.2012 which states that in continuation to the advisories on Product Approval No.P.15025/219/2011-PA/FSSAI and No.P.15025/24/2012-PA/FSSAI, it is clarified that provisional NOC will be issued for one year in case of existing license holders/importers for ::: Downloaded on - 13/02/2014 23:11:31 ::: 71 WP2746.13 proprietary food products/ingredients and also for new products/ingredients which have had a proven record for safety for human consumption in other countries. It states that products/ingredients which are absolutely new and have never been used in any country and their safety assessment has not been carried out shall not be issued a provisional NOC. Their applications will be forwarded to the Scientific Panel/ Scientific Committee. It states that manufactures of traditional foods and local cuisine like Atta, Suji, Dal, savouries like Samosa, Bhujia, Gulabjamun etc. which are most commonly used by the consumers need not submit their applications for product approval as a proprietary food. It is further stated that the applicant shall submit the applications for product approval in the prescribed format with the fees of Rs.25,000/- (non refundable) with soft copies and gist of the dossiers irrespective of number of products/ingredients for which the dossiers and applications have been submitted for single category.
(II) Advisory dated 10.9.2012.:- This advisory is issued in regard to the details of the licenses issued without "Product Approval" (cases where Product Approval was requested). It states that this advisory is issued in continuation with the Statutory Advisory issued on 4.7.2012 regarding issuance of licenses for proprietary foods without product approval. It states that FSS Act,2006 stipulates that all manufactures/processors/importers who ::: Downloaded on - 13/02/2014 23:11:31 ::: 72 WP2746.13 will be introducing any such new product which is not as per the approved list of products under FSS Regulations, need to obtain product approval. In this regard, the State Food Safety Commissioner is requested to provide details of all such cases where licenses were issued for such products. It states that the cases where licenses were issued for such products which were not approved and product approval was required from Central Authority as per Section 22, may be sent to FSSAI so that further action can be taken. All such products will have to be granted provisional NOC or referred to the Panel as per procedure for further action. It further provides that after obtaining product approval, licenses may be issued by the State or Central authorities as per the production capacity/turnover (as the case may be). It is stated that till the time product has not been approved by FSSAI and FBO is working on the NOC, the FBO needs to take Central License. It is stated that this is necessary as the product is only provisionally allowed and is not an approved product and will thus be covered under Section 22.
(III) Advisory issued on 30.1.2012:- By this advisory the Food Authority has stated that the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations,2011, provide a list of food businesses falling under provision of Central Licensing Authority. It is stated that it covers all food business operators manufacturing any article of ::: Downloaded on - 13/02/2014 23:11:31 ::: 73 WP2746.13 food containing ingredients or substances or using technologies or processes or combination thereof whose safety has not been established through these regulations or which do not have a history of safe use or food containing ingredients which are being introduced for the first time into the country. It is stated that they need to apply for Product Approval at FSSAI Headquarters before applying for Licence. A copy of the application format is annexed to the said advisory.
(IV) Advisory issued on 14.2.2012:- This advisory is issued for clarification relating to Product Approval Procedure. It is stated that the applicants should apply for the approval of each product/ingredient separately for new product/ingredient Approval in the prescribed format and applications should be addressed to Director (PA), Food Safety and Standards Authority of India, FDA Bhavan, Kotla Road, New Delhi-110002.
It is clarified that for obtaining product approval the Food Business Operator will make an application in the prescribed format with an initial payment of non refundable INR 25000 in the form of Demand Draft drawn in favour of Senior Account Officer, FSSAI towards initial screening of the application by the "Approval Screening Committee". The Approval Screening Committee will decide whether the product is falling under the Category A or Category B. It is stated that in case of Category A the Approval Screening ::: Downloaded on - 13/02/2014 23:11:31 ::: 74 WP2746.13 Committee will deliberate and decide for the approval or rejection of the same on the basis of the information submitted by the applicant. It is stated that in case it requires further assessment in respect of safety etc. the application will come in Category-B and the matter will be assessed by the scientific panel/expert group and thereafter scientific committee for the approval or rejection of the same for which additional payment of INR 25000 (non refundable) to be remitted by the applicant.
(V) Advisory issued on 22.3.2012. It pertained to procedure adopted by FSSAI for approval of proprietary products/ingredients already being manufactured under licenses of erstwhile Acts/Orders. This advisory records decisions of the Food Authority taken to facilitate the ongoing trade of the food and inter alia states that the applicant may submit the application in the prescribed format with the fees (non refundable) and include all the documents and scientific justification of the safety of the product being manufactured and also may submit the evidence such as license obtained under erstwhile Acts and Orders for manufacturing of such product. It further states that existing licence holders under the earlier Acts, Regulations and Orders may apply for conversion to FSS licence in respect of products already under manufacture but whose safety assessment has not been carried out. It is stated that in such cases the ::: Downloaded on - 13/02/2014 23:11:31 ::: 75 WP2746.13 Product Approval Division on receipt of completed application will give NOC for issuance of a provisional FSS license for a period of one year or till the risk assessment process is completed whichever is earlier. It is stated that an importer of proprietary products/ingredients shall also submit the application to the product approval division with the prescribed fees, required data and the evidence that applicant was in the trade of import of such products till the date of filing the application. It is stated that on receipt of the application, Product Approval Division will proceed in the same manner as provided in respect of existing licence holder under the old Act and orders. It is stated that provisional license shall be issued subject to such other conditions as may be necessary to ensure safety and public health.
(VI) Advisory issued on 6.8.2012. By this advisory, it is stated that Section 22 of FSS Act, 2006 read with Sections 16 and 18 of FSS Act, and as per Schedule 1 the Food safety and Standards (Licensing and Registration of Food Businesses) Regulations,2011 provide that all food business operators manufacturing any article of food containing ingredients or substances or using technologies or processes or combination thereof whose safety has not been established through these regulations or which do not have a history of safe or food containing ingredients which are being introduced for the first time into the country need to apply for product approval before applying for ::: Downloaded on - 13/02/2014 23:11:31 ::: 76 WP2746.13 licence. It states that the applicant may make application in prescribed format with the fees of Rs.25,000/- (non refundable) with soft copies of dossier alongwith a Executive Summary documents etc. It also states that provisional NOC will be issued for one year in case of existing licence holders/ importers for proprietary food products/ ingredients and also for new products/ ingredients which have had a proven record for safety for human consumption in other countries. It further states that the products/ ingredients which are absolutely new and have never been used in any country and their safety assessment has not been carried out shall not be issued a provisional NOC. It states that their applications will be forwarded to the Scientific Panel/Scientific Committee. It clarifies that manufacturers of traditional food and local cuisine like Atta, Suji, Dal Savouries like Somasa, Bhujia, Gulabjamun etc., which are most commonly used by the consumers need not submit their applications for product approval as a proprietary food. It is stated that application complete in all respect shall be placed before Product Approval Screening Committee on a weekly basis for consideration and on the basis of NOC issued by the Product Approval Screening Committee, Central/State Licensing Officer will issue licence for manufacturing on the basis of turnover of the company, and that the import licence shall be issued by the Central Designated Officer. It further states that all license holders who were issued licenses previously under the Acts or ::: Downloaded on - 13/02/2014 23:11:31 ::: 77 WP2746.13 Orders mentioned in the Second Schedule of the FSS Act shall be allowed to continue with their business including import for which such licences have been issued while there application for Product Approval in the prescribed format are processed for issuance of an NOC or final approval.
(VII) Advisory issued on 26.10.2012. This advisory is issued to clarify the Product Approval advisory dated 6.8.2012 and more particularly paragraph 4 of the said advisory.
(VIII) Advisory issued on 26.10.2012. This advisory inter alia states that Product Approval Division of Food Safety and Standards Authority of India issued provisional NOC for a period of one year or till the outcome of risk assessment of the product whichever is earlier to various manufacturer/importer subject to the conditions that the applicant shall get the product/ingredient approval with proof of safety provided by the applicant in stipulated time. It is stated that if the final product approval is negative and not granted/cancelled the NOC must be withdrawn. It is stated that Licensing Section must be informed about the recalling of the product from the market and not introduce such product which is available with the FBOs and possibly cancellation of license. It is stated that Food Safety Commissioner as well as the concerned DO's will be informed for ::: Downloaded on - 13/02/2014 23:11:31 ::: 78 WP2746.13 cancellation, recall and to stop continued release of the product in market. It is stated that the State Government issuing the licence on the basis of NOC, should be informed to carry out these three operations and report compliance to the Food Authority.
(IX) Advisory dated 11.12.2012. This advisory provides for a procedure regarding new product approval. It is inter alia stated that several advisories relating to procedures for obtaining Product Approval before application for license have been issued and published by Food Authority on website and for which several queries and concerns were received from the Food Business Operators regarding the complexity and time lines for product approval. It is stated that further to streamline the product approval procedure and the licensing of these foods in a timely manner with due consideration to the safety of foods and public health as well as for the smooth continuance of trade a detailed procedure is set out.
It is stated that all advisories and clarifications regarding product approval issued previously will be superseded with the new procedure referred as "New Product Approval Procedure". Detail guidelines were set out in paragraph (1) to paragraph (3), inter alia in regard to grant of product approval licensing conditions and fees. Paragraph 1 of these guidelines which is of relevance which reads as under:-
::: Downloaded on - 13/02/2014 23:11:31 ::: 79WP2746.13 "1. Foods or food categories covered under the NPA procedure and required to obtain product approval:
a. Proprietary Foods that have been granted license under previous Acts/ Orders (PFA, MMPO, MFPO etc.) and have been in the market prior to 31 st March,2011 or new food products intended to be placed on the market and do not contain Novel Foods, Functional Foods, Food Supplements, Irradiated Foods, Genetically Modified Foods, Foods for Special Dietary Uses or extracts or concentrates of botanicals, herbs or of animal sources shall be granted product approval under the following condition:
i.
ig The FBO has provided a complete list of ingredients and food additives as mentioned on the label (Copy of label to be attached for products in market) and ii. The FBO has provided the category number as applicable under the Indian Food Category Code. iii. Where the application is in accordance to conditions as in 1(a) above and in the format (Format 1a)
-FSSAI shall grant Product Approval and the FBO may proceed to obtaining a license as provided under paragraph (2) below b. Foods labelled as proprietary foods, whether licensed under previous Act/Orders or are intended to be placed on the market and contain Novel Foods, Functional Foods, Food Supplements, Irradiated Foods, Genetically Modified Foods, Foods for Special Dietary Uses or extracts or concentrates of botanicals, herbs or of animal sources shall be apply for product approval and grant of provisional NOC as provided under paragraph (2) below.
c. Foods products requiring product approval shall be made in the application form as provided by FSSAI (Format 1b). Furthermore i. Safety documentation is required for all ingredients except for vitamin and minerals or food additives approved under FSSR 2011 or Codex (JECFA) ::: Downloaded on - 13/02/2014 23:11:31 ::: 80 WP2746.13 ii. The FBO shall also declare the category under which he intends to market the product as specified under Section 22 - namely food supplement, food for special dietary uses, functional food etc. or any other recognised under international regulations."
ADVISORY UNDER CHALLENGE.
(X) Advisory dated 11.5.2013. This advisory which from its contents appear to incorporate several traits of the earlier advisories on product approval (supra) has been issued in superceding of all earlier advisories in regard to Product Approval. It sets out the guidelines to be followed by the Food Authorities for product approval procedure. The challenge of the petitioners is confined to this final advisory and therefore, the contents of the same are required to be considered in detail as under:-
It is stated in this advisory that the earlier advisories relating to procedure for Product Approval were posted on the website of the Food Authority and that a feed back on the same was received from various stake holders regarding the complexity and time lines for product approval. It is stated that to streamline the product approval procedure with due consideration to the safety of food and public health, in supersession of earlier advisories, food products for which the standards are not specified under FSS Act 2006, Rules and Regulations made thereunder will be granted product approval. It is stated that the procedure as set out in paragraphs 1 to ::: Downloaded on - 13/02/2014 23:11:31 ::: 81 WP2746.13 9 would come into force with immediate effect. The relevant portions of this advisory read as under:-
"1(a) Food products where the safety of its ingredients present are known and are permitted under FSS Regulation,2011/Codex and other regulatory bodies like EU/FSANZ/USFDA etc. and the food product does not contain plants or botanicals or substances from animal origin will be granted product approval. The application in form 1(a) alongwith the affidavit to be submitted by the Food Business Operator (FBO) for the product approval shall be accompanied by following documents:
i Complete list of ingredients (specify the level of its use) ii. Copy of the label for products in the market/ to be placed in the market.
iii.ig Category number of the product as applicable under the Indian Food Category Code.
After scrutiny of the application and documents and on the condition that the documents submitted by the FBO are satisfactory, Product Approval Division (PAD) shall grant the product approval.
1(b) Food products where the safety of its ingredients present are known and are permitted under FSS Regulation, 2011/Codex and other regulatory bodies like EU/FSANZ/USFDA etc. and the food product contain ingredients including plants or botanicals or substances from animal origin shall be considered for Product approval/NOC. PA will be given to all products where safety assessment is completed. NOC will be granted to food products in market where license has been granted under previous Act/Orders. The application in form 1(b) along with the affidavit to be submitted by the Food Business Operator (FBO) for the product approval will be accompanied by following documents: i. Complete list of ingredients (specify the level of its use) ii. copy of the label for products in the market/ to be placed in the market.
iii. Category number of the product under the Indian Food Category Code.
1(c) Food products falling under category 1(b) above prima facie where safety of the ingredients is insufficient to make a safety determination would be referred to respective Scientific Panels. Product approval shall be granted/denied on the basis of risk assessment.
1(d) Products for which the safety of its ingredients and their ::: Downloaded on - 13/02/2014 23:11:31 ::: 82 WP2746.13 conditions of use as stated therein and published by FSSAI or products whose ingredients are standardized or permitted under FSSR 2011 will not require further safety assessment except for authorization of the ingredients contained therein. The application in form 1(d) along with the affidavit to be submitted by the Food Business Operator (FBO) for the product approval will be accompanied by following documents:
i. Complete list of ingredients (specify the level of its use) ii. Copy of the label for products in the market/ to be placed in the market.
iii. Category number of the product under the Indian Food Category Code.
iv. Copy of PA/NOC issued by FSSAI.
2. Safety data wherever required should be provided for all the ingredients.
3. The use of minerals/ vitamins/ proteins/ metals/ amino acids/ their compounds should not exceed the Recommended Daily Allowance for Indians. In this regard, FBO shall follow the guidelines issued by Indian Council of Medical Research (ICMR) / National Institute of Nutrition (NIN)/ World Health Organization (WHO)/ Food and Agriculture Organization (FAO)
4. In case of rejection of application under the approval procedure, the product under reference shall be recalled as per the provisions laid down in FSS (Licensing and Registration of Food Businesses) Regulations 2011."
This advisory has been annexed with the forms of affidavit and other details which are required to be provided by the Food Business Operators.
18. After considering the aforesaid details of the various advisories on Product Approval, it is necessary to have a look at the other materials as produced by the Petitioners. The petitioners have annexed to the writ petition, application/letter of one of the members of Petitioner no.2 which appear to have been filed on 14.11.2012 addressed to the Food Authority ::: Downloaded on - 13/02/2014 23:11:31 ::: 83 WP2746.13 being an application for approval of new product viz. ENERGYA Flexi Food & ENERGYA Forti Food which are described to be dietetic products under category 13.6 as health supplement. A prescribed application with fees of Rs.25,000/- was paid by the said company to seek product approval alongwith necessary information. Thereafter, by another letter, further documents were submitted by the said company to seek a product approval.
In reply to the same, the Food Authority addressed a letter dated 23.9.2013 in respect of one of the products submitted for approval namely "Enbergya Fortifood (Mango Flavour)". The Food Authority stated that the application for product approval of the said product was examined and discussed in the 71st Product Approval & Scientific Committee meeting held on 10.9.2013 wherein it was recommended by the 'Product Approval and Scientific Committee' that NOC may not be issued to the said product as the product has large number of vitamins and minerals and the case may be forwarded to Scientific Panel for Functional Foods, Nutraceuticals, Dietetic Products and other similar products, and hence, a fresh application was requested to be submitted as per the prescribed format.
19. The petitioners have also annexed a letter of the Food Authority dated 8.10.2013 which is a reply to an application under RTI by which information is given by the Food Authority that the application fees of ::: Downloaded on - 13/02/2014 23:11:31 ::: 84 WP2746.13 Rs.25,000/- for approval of Nutraceuitical product has not been prescribed under the Food Safety and Standards Act, Rules and Regulations made thereunder, but however, it has been prescribed in the guidelines issued for product approval issued under Section 16(5) of Food Safety and Standards Act,2006. It is also stated that additional fee of Rs.25,000/- for referring the application to Scientific Panel has not been charged since 5.9.2013.
20. On the conspectus of the aforesaid facts and the legal position as envisaged under the FSS Act and the relevant Regulations, we have heard Mr.I.M.Chagla, learned Senior Counsel alongwith Mr.Riyaz Chagla learned Counsel appearing on behalf of the Petitioners, Dr. G.R.Sharma alongwith Mr. G.Hariharan learned Counsel appearing on behalf of Respondent no.1 and Mr.Mehmood Pracha alongwith Mr.I.A.Khan learned Counsel appearing on behalf of Respondent no.2 who is contesting the writ petition.
21. On behalf of the Petitioners, the following submissions are made in support of the challenge as raised in the petition:-
::: Downloaded on - 13/02/2014 23:11:31 ::: 85WP2746.13 (I) That Food Authority does not have any authority, power or jurisdiction under the Food Safety and Standards Act,2006 (hereinafter referred to as 'FSSA') read with Rules and Regulations framed thereunder to issue the impugned advisory dated 11th May,2013 providing for product approval.
That Respondent no.2 cannot act in the absence of a specific power conferred on it under the Food Safety and Standards (Food Products Standards & Food Additives) Regulations,2011 and Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations,2011. It is submitted that these regulations confer specific power and authority in regard to licensing and registration of food businesses. It is submitted that the concept of product approval in no manner is contemplated under these Regulations and hence, the impugned advisory is per se arbitrary and illegal, being contrary to the provisions of the Act, Rules and Regulations.
(II) It is submitted that the Food Authority being a ::: Downloaded on - 13/02/2014 23:11:31 ::: 86 WP2746.13 delegate empowered to frame regulations under Section 92 of the Act, is duty bound to exercise powers in the manner prescribed by law and in no other manner. It is submitted that the Food Authority has already framed the FSS (Licensing and Registration of Food Businesses) Regulations,2011. It is submitted that a procedure for licensing and registration has been set out under Regulation 2.1 and in its various sub-regulations. It is submitted that the clauses of these regulations no where provide for a product approval to be obtained by the manufacturers who are holding a valid licence and who are already manufacturing the food products under an existing license.
It is submitted that in view of the specific provisions of these Regulations, such other procedure to seek a product approval cannot be imposed on such category of manufacturers. It is further submitted that the only method to adopt such a procedure is to frame regulations to that effect in exercise of the powers conferred on the Food Authority under Section 92 and Section 93 read with Section 16(2) of the FSS Act. It is further submitted that the ::: Downloaded on - 13/02/2014 23:11:31 ::: 87 WP2746.13 impugned advisory is per-se beyond the purview and scope of the regulations, hence ultra vires.
(III) It is submitted that the impugned advisory is infringing the rights of the petitioners as guaranteed under Articles 14, 19(1)(g) and 300A of the Constitution of India inasmuch as the Petitioners who are food manufactures are unwarrantably required to undergo the procedure of product approval as a condition for renewal of the licence or to conduct the Food Businesses, which is wholly unwarranted in view of the fact that the Petitioners are already holding a valid licence to undertake manufacturing of food products.
(IV) In support of the aforesaid submissions Mr.I.M.Chagla, learned Senior Counsel appearing on behalf of the petitioners has made elaborate submissions and has taken the Court through various provisions of Food Safety and Standards Act,2006, the Rules and the different Regulations framed thereunder and various averments as made in the writ petition.
::: Downloaded on - 13/02/2014 23:11:31 ::: 88WP2746.13
22. On behalf of the Food Authority Mr.Mehmood Pracha learned Counsel has made extensive submission on varied of issues of food safety and the endeavour of the Food Authority to make wholesome food available to the consumers. The Food Authority has filed an affidavit in reply to the writ petition opposing the reliefs in the writ petition.
The learned Counsel appearing on behalf of Food Authority has contended that the advisories issued from time to time are well within the framework and powers vested under the FSS Act and serve as a guiding factor as to how and in what manner the particular issue is to be dealt with depending upon different products for which that particular advisory has been issued. It is submitted that any order passed in the writ petition would amount to a very precarious situation as the advisories are released in consonance with the Statute for laying down science based standard 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. It is stated that the object of ::: Downloaded on - 13/02/2014 23:11:31 ::: 89 WP2746.13 FSSAI is to ensure availability of safe and wholesome food for human consumption. It is stated that there are 377 existing standards which are present in the regulations and in that all proprietary food items which are not standardised have to be assessed for their safety and for some of them standards need to be developed. It is stated that in order to address these items and facilitate industry and food processing units in the country, an administrative system was put in place to ensure that all non-standardised food is screened for safety.
It is stated that the Product Approval (PA) is sought by Food Business Operators for all products which do not have prescribed standards as per FSSR and it is towards this endeavour the Food Safety Authority has issued guidelines from time to time which have been modified for simplification for use by stake holders and with active participation of all concerned with an intention to achieve objective and scope by the statute. It is stated that had there been no advisories issued by the Food Authority, it could have led to chaotic situation where there would not have been uniformity in approach and stake holders in particular will not be aware of ::: Downloaded on - 13/02/2014 23:11:31 ::: 90 WP2746.13 the procedure and requirements under the statute. It is further submitted that the Food Safety Authority under the regime of the present Act and Regulations framed thereunder is at nascent stage and is evolving day by day. It is stated that the approach of the Authority has been transparent keeping abreast the scope and object of the Act and Rules and Regulations framed thereunder and to promote general awareness as to food safety and food standards. It is further submitted that from time to time the Food Authority has taken into consideration the feedback, suggestions etc. from the stake holders and accordingly formulated and issued various orders and advisories etc. for making the Food Authority model consumer friendly which would help in achieving the basic object of safe and secured food for the public at large. It is submitted that a duty has been cast upon the Food Authority to promote, co-ordinate, issue guidelines for development of risk assessment methodologies and to monitor, conduct and forward messages on the health and nutritional risks of food to all concerned. It is further submitted that no actions, policy ::: Downloaded on - 13/02/2014 23:11:32 ::: 91 WP2746.13 decisions, powers exercised, etc. impugned in the present petition can be termed as arbitrary or bad-in-law. It is stated that till date no representation whatsoever by any of the petitioners has been made and hence, on the lack of any representation being made, the petition is liable to be dismissed on that count. It is therefore, submitted that the Advisories issued are consistent with the provisions of the Act and are issued in view of the powers conferred under Act with an intention to achieve object and scope under the Statute, and hence, they are neither unconstitutional nor illegal or impossible to perform. It is further submitted that the advisories are neither unconstitutional nor illegal or impossible to perform as they have been issued after consultation and taking into consideration international practice under the subject. It is submitted that it is based on international legislations, instrumentalities and Codex Alimentarius Commission which is related to food safety standards and norms which are taken as reference points in the framework of WTO. It is submitted that the advisories are issued in the larger public interest to inter alia ensure ::: Downloaded on - 13/02/2014 23:11:32 ::: 92 WP2746.13 better food safety to set and regulate standards based on science and transparency including fair practices in all kinds of food trade with reference to food safety, standards and practice. It is further submitted that the advisories are issued with an intention to achieve object and scope of the Statute and for betterment of public at large and are laying principles for the officials of Food Business Operators (for short "FBO's") and are based on powers conferred on the Authority under Section 16 and 18 of the Act. It is further submitted that the object of FSS Act is to eliminate danger to human life from the sale of unsafe food and to ensure that what is sold is wholesome food. It is stated that the Food Authority was established in the year 2008 and is in force with effect from 5.8.2011 and that in last two years the Food Authority has initiated central licensing, operationalised its regional / sub-regional import officers and on-line licences and registration system and food import control system. It is submitted that it has also constituted scientific aiding and nine scientific panels as per the provisions of the Act. It is submitted that the task of regulating food and establishing ::: Downloaded on - 13/02/2014 23:11:32 ::: 93 WP2746.13 enforcement structure is onerous, but the authority is doing its best not only to achieve the goals and ensure safe food but also to set science based standard for food items. It is submitted that the Act has been made fully operational with effect from 5.8.2011 and is still in its nascent stage and Regulations in number of areas are yet to be framed.
23. It is further submitted on behalf of the Food Authority that under the FSS Act it is responsibility of the Food Authority to promote consistency with the relevant international standards and that this would facilitate availability of safe food to the consumer. It is stated that the standard and other guidelines adopted by Codex Alimentaries Commission, United Nations, another Governments, set up of FAO/WHO are the relevant international standards and also reference of the framework of WTO. It is submitted that in exercise of the said powers / duties the Food Authority has already started process of review and harmonizing the standards as well as laid down new standards consisting with Codex Standards and other ::: Downloaded on - 13/02/2014 23:11:32 ::: 94 WP2746.13 international based products. It is stated that as per Point VIII of Schedule I of the Licence Regulations, licence to all Food business Operators manufacturing any article of food containing ingredients or substance or using technologies or processes or combination thereof whose safety has not been established through these regulations or which do not have a history of safe use or food containing ingredients which are being introduced for the first time into the country are being issued by Central Licensing Authority. It is submitted that safety of said products is not determined and relevant regulations regarding safety of such product are under process, and that the product in question cannot be left unregulated. It is stated that accordingly for monitoring manufacture, distribution, storage and sale or import of such food so as to ensure safe and wholesome food for human consumption the process of product approval is framed which is consistent with the provisions and that it is consistent with the provisions of Sections 16 and 18. It is further stated that under provisions of Section 82(2) of the FSS Act the Food Authority under recommendation of Central ::: Downloaded on - 13/02/2014 23:11:32 ::: 95 WP2746.13 Advisory committee has power to specify a graded fee from licensed food business operator, accredited laboratories or food safety auditors to be charged by the Commissioner of Food Safety. It is submitted that in pursuance of the provisions under Section 82(2) of the FSS Act, the Central Advisory Committee in its 8th meeting has recommended that any unit manufacturing novel food, genetically modified food, irradiated food, organic foods, nutraceuticals, proprietary foods etc. have to apply for product approval in the prescribed format before obtaining Central license. It is submitted that for the risk assessment, the Food Authority has constituted the Scientific Panels/Committees which are its risk assessment bodies and these panels/committees meet on regular basis to consider various applications of FBO's and every such single meeting costs about Rs.2.50 to Rs.3 lakhs on a conservative estimate. It is therefore, submitted that impugned advisories are issued following the procedure prescribed under the Act. It is submitted that in fact the enforcement of the Act may also require the Food Authority to issue Advisories/guidelines from time to time ::: Downloaded on - 13/02/2014 23:11:32 ::: 96 WP2746.13 consistent with the provisions of the Act for smooth and transparent implementation of the Act. In the affidavit of the Food Authority, it is also submitted that the intention of the legislature in making the provision of sub-section 3 of Section 97 and accordingly framing of regulation 2.1.2 (1) of the Licensing Regulations by the Food Authority was to have such provisions to facilitate shifting of food business operators (FBO) into new regime with new license number and thus a provision was kept that he need not to pay license fee till the date an old license was valid. It is stated that this would facilitate a proper data base of FBOs whose licenses are going to expire within one year of transition period and that the FBO has to renew his license before the existing license expires. It is further submitted that during this period of transition State as well as Central authorities are also undergoing administrative changes and were adjusting to the procedural changes under the FSS Act. It is submitted that the staff is inadequate in most of the State and despite best efforts there is lack of clarity among FBOs. It is stated that expectation of non compliance in PFA (Prevention of Food ::: Downloaded on - 13/02/2014 23:11:32 ::: 97 WP2746.13 Adulteration Act) continued and that Schedule IV of the licensing regulations provides for good manufacturing practices and that new Act has provision of FSMS plan. It is stated that Food Business Operators are not prepared at this point of time and may take time for adjusting to the new expectations. Reference in that regard is made in Regulation 2.1.7(6) which provides that Food Business Operator having valid certificate of an accredited food safety auditor or from an agency accredited by Food Authority or any other organisation notified by food Authority for this purpose will not be normally required to be inspected before renewal of license, provided that the Designated Officer may order an inspection before renewal if considered necessary for reasons to be recorded in writing. It is submitted that FSS Act has been made fully operational from 5.8.2011 and still it is in nascent stage and hence there is nothing arbitrary or illegal in the Food Authority undertaking Product Approval. It is submitted that the same is issued in the larger public interest and for the ultimate safety of human health so that wholesome food is available for human consumption and ::: Downloaded on - 13/02/2014 23:11:32 ::: 98 WP2746.13 hence the Food Authority is also morally correct in insisting on a product approval. It is submitted that the implementation of the Act, Rules and Regulations primarily rests with the Government of different States/ Union Territories and the role of the Food Authority is to monitor and coordinate with the States/U.T. Governments for efficient implementation of the Act. It is stated that the advisories and guidelines issued by the FSSAI from time to time were to guide the stake-holders and food Authority/ State Government officers responsible for ;the implementation of the Act for the sake of uniformity and transparency in application of the Rules, Regulations and Procedures. It is stated that the advisories and guidelines issued by the Food Authority are consistent with the provisions of the Act, Rules and Regulations made thereunder.
24. On the aforesaid rival submissions, the question which arises for consideration is as to whether the impugned advisory dated 11.5.2013 providing for a product approval procedure has been issued by the Food Authority under valid ::: Downloaded on - 13/02/2014 23:11:32 ::: 99 WP2746.13 authority and powers under the FSS Act.
25. To answer the said question, the provisions of Section 16, 18 and 22 of the Act are required to be carefully examined. Section 22 provides for genetically modified goods, organic foods, functional foods, proprietary foods etc. and stipulate that save as otherwise provided under the FSS Act and regulations made thereunder, no person shall manufacture, distribute, sell or import any novel food, genetically modified articles of food, irradiated food, organic foods, foods for special dietary uses, functional foods, neutraceuticals, health supplements, proprietary foods and such other articles of foods which the Central Government may notify in this behalf. The explanation under the said provision defines as to what is meant by "Food for special dietary uses or functional foods or nutraceuticals or health supplements". Explanation (4) to Section 22 of the Act defines "proprietary and novel food" which means an article of food for which standards have not been specified but is not unsafe. Proviso to Section 22 of the Act defines that ::: Downloaded on - 13/02/2014 23:11:32 ::: 100 WP2746.13 such food does not contain any of the foods and ingredients prohibited under this Act and the regulations made thereunder.
26. The provisions of Section 22, therefore, indicates that the category of foods as falling under the said provisions are fully controlled in respect of its manufacture, distribution, sale or import except as otherwise provided under the Act and the regulation which may be made, they cannot be dealt in any manner. The effect of this provision is that no Food Business Operator would be permitted to manufacture, distribute, sale or import any novel food, genetically modified articles of food, irradiated food,organic foods, 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, unless the Act or the Regulations made thereunder otherwise so permit. The embargo as created by the said provision is not only to manufacture but also for distribution, sale or import of such category of food. The intention of the said ::: Downloaded on - 13/02/2014 23:11:32 ::: 101 WP2746.13 provision appears to be that right from the manufacture of such food till it reaches the consumer only if so made permissible by the concerned Authorities from the point of view of food safety and its effects on the human body.
27. To consider the operation of Section 22 and its implementation at the hands of the Authorities, the effect of the provisions of Sections 16 and 18 is also required to be examined. Section 16 defines duties and functions of Food Authority. Relevant provisions being Sub-sections (1), (2), (5) of Section 16 reads as under:-
"16. Duties and functions of Food Authority-
(1) 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.
(2) Without prejudice to the provisions of sub-section (1), the Food Authority may by regulations specify-
(5) 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 this Act;"
(emphasis supplied) A plain reading of Sub-Section (1) Section 16 of the Act indicates that it is ::: Downloaded on - 13/02/2014 23:11:32 ::: 102 WP2746.13 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. The provision, therefore, encompasses a duty and an obligation on the Food Authority to exercise complete control and monitoring on matters of manufacture, processing, distribution, sale and import with an object to ensure safe and wholesome food. The words 'to regulate' and 'monitor' are of considerable significance inasmuch as the Food Authority would have all the powers to control and monitor such of the attributes of manufacture, processing, distribution, sale and import of food which would be ultimately made available for human consumption.
28. Further it is apparent that the duty which is being imposed by sub-section (1) of Section 16 of the Act on the Food Authority to regulate and monitor manufacture, processing, distribution, sale and import of food so as to ensure safe and wholesome food, is distinct and independent, for the reason that sub-section (2) which begins with the words "without prejudice to the provisions of sub-section (1), the Food Authority may by regulations specify", indicate that the Legislature in making the provisions of sub-section (2) has consciously kept sub-section (1) uninfluenced by the contents of the said subsequent provision. This indicates that, an unfettered duty is cast on the Food Authority to regulate and monitor the manufacture, ::: Downloaded on - 13/02/2014 23:11:32 ::: 103 WP2746.13 processing, distribution, sale and import with the ultimate object to ensure safe and wholesome food for human consumption which has been kept undisturbed by the subsequent provisions of this section, the intention being that the said powers are required to be exercised by the Food Authority to achieve the object of providing safe and wholesome food. In order to enable the Food Authority to exercise its functions in that direction, the Legislature has also made a further provision in the nature of sub-section (5) of Section 16 which provides that 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 this Act. This indicates that in exercise of this power, the Food Authority can make such directions on matters pertaining to the administration of the Act that is relating to food safety and standards to be issued from time to time i.e. in different situations which may or may not be contemplated under the Regulations. It is, therefore, difficult to accept the contentions of the petitioners that the Food Authority is without any authority and power to issue advisories as also the impugned advisory dated 11.5.2013 which has the intention to bring about a regime of approved Food Products available for human consumption. It is contended on the part of the Food Authority that the advisories are issued with an intention to achieve the objective and scope of the Statute and are for betterment of the public at ::: Downloaded on - 13/02/2014 23:11:32 ::: 104 WP2746.13 large and that they are the guiding principles for officials, FBO (Food Business Operators) and other persons etc. concerned and dealing with the Statute and are based on the powers conferred on the Food Authority under Sections 16 and 18, and that the Food Authority in issuing the impugned advisory is competent to act in exercise of powers under Section 16. There is considerable substance in the submission made by the learned Counsel for the Food Authority. In my opinion, in view of the clear provisions of Section 16 sub-section (1) and sub-section (5), it would not be correct to say that the Food Authority is without any power and authority to provide for a Product Approval so as to achieve the object and purpose of the Act and that whatever food product which is ultimately available for human consumption is only a product which is approved and nothing less. If such is an object of the Food Authority to bring a regime of only approved food product to be made available in the market, it cannot be said that the Food Authority is acting arbitrarily. If the Petitioners' contention is accepted that the Food Authority does not have an authority to issue the impugned advisory, the very object to bring about a regime of approved products available for human consumption would stand defeated as also, the provisions of Section 16(1) and 16(5) would be rendered meaningless. The Legislature has abundantly clothed the Food Authority with powers to perform its duty to ensure safe and wholesome food for human consumption by providing in no ::: Downloaded on - 13/02/2014 23:11:32 ::: 105 WP2746.13 unclear terms with every aspect not only in regard to the manufacture but in processing, in distribution, in sale, in import, with an object to ensure safe and wholesome food. The intention of the legislature is apparent from the plain reading of sub-section (1) of Section 16 which just cannot be overlooked. Furthermore the provisions of sub-section (5) permits and empowers the Food Authority from time to time to give such directions "on the matters relating to food safety and standards". If due meaning as is projected by the words used in both these provisions is overlooked, the functioning of the Food Authority to attend the object of providing safe and wholesome food and to achieve food safety and its standard can seriously be jeopardized. The Food Authority therefore would be entitled and justified to act under the mandate of the said legislative provisions and by such exercise of its powers is authorised to issue the impugned advisories. It therefore cannot be said that such action is in any manner without authority in that regard.
29. Apart from the aforesaid position, Section 18 of FSS Act provides for general principles to be followed in administration of the Act by the 'Central Government', 'State Government' and the 'Food Authority' and other agencies, as the case may be, while implementation of the provisions of the Act. This provision stipulates that the said Authorities would be guided ::: Downloaded on - 13/02/2014 23:11:32 ::: 106 WP2746.13 by the following principles as envisaged in sub-section (1) of Section 18:-
"(1) (a) endeavour to achieve an appropriate level of protection of human life and health and the protection of consumers' interests, including fair practices in all kinds of food trade with reference to food safety standards and practices;
(b) carry out risk management which shall include taking into account the results of risk assessment, and other factors which in the opinion of the Food Authority are relevant to the matter under consideration and where the conditions are relevant, in order to achieve the general objectives of regulations;
(c) where in any specific circumstances, on the basis of assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure appropriate level of health protection may be adopted, pending further scientific information for a more comprehensive risk assessment;
(d) the measures adopted on the basis of clause (c) shall be proportionate and no more restrictive of trade than is required to achieve appropriate level of health protection, regard being had to technical and economic feasibility and other factors regarded as reasonable and proper in the matter under consideration;
(e) the measures adopted shall be reviewed within a reasonable period of time, depending on the nature of the risk to life or health being identified and the type of scientific information needed to clarify the scientific uncertainty and to conduct a more comprehensive risk assessment;
(f) in cases where there are reasonable grounds to suspect that a food may present a risk for human health, then, depending on the nature, seriousness and extent of that risk, the Food Authority and the Commissioner of Food Safety shall take appropriate steps to inform the general public of the nature of the risk to health, identifying to the fullest extent possible the food or type of food, the risk that it may present, and the measures which are taken or about to be taken to prevent, reduce or eliminate that risk; and
(g) where any food which fails to comply with food safety requirements is part of a batch, lot or consignment of food of the same class or description, it shall be presumed until the contrary is proved, that all of the food in that batch, lot or consignment fails to comply with those requirements."
It is, therefore, apparent that the entire endeavour of the Food Authority is to ::: Downloaded on - 13/02/2014 23:11:32 ::: 107 WP2746.13 achieve an appropriate level of protection of human life and health and the protection of consumers' interests, including fair practices in all kinds of food trade with reference to food safety standards and practices. This includes determination of harmful effect on health to be identified to ensure appropriate level of health protection and all scientific steps be taken in that regard. Wherever there are reasonable grounds to suspect that certain food may present a risk of human health then depending upon the nature and seriousness and to the extent of that risk, it is mandatory that the Authorities are required to take appropriate steps to protect the health and every possible measure in relation to that as is clear from the reading of the aforesaid principles enshrined in sub-section (1) of Section 18. Hence, while implementing the provisions of the Act, if the Food Authority is undertaking an exercise to have a Product Approval so as to ascertain the ingredients of a product in the method as envisaged by it, irrespective of the fact that it is a licensed product, it cannot be said that the Food Authority is acting in any manner contrary to the said substantive provisions of the Act, which in fact casts duty and obligation to achieve not only Food Safety and Standards but the ultimate object of protecting the human livelihood which would otherwise be seriously affected if unsafe and sub-standard or dangerous food is left for consumption of the innocent people who will be hardly aware of the hazardous nature of ingredients of such food.
::: Downloaded on - 13/02/2014 23:11:32 ::: 108WP2746.13
30. In the present case, the Advisories which are issued are in respect of a category of food falling under Section 22 of FSS Act which creates a bar on any person who manufacture, distribute, sale or import any novel food, genetically modified articles of food, irradiated food, organic foods, 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, which can be so dealt only otherwise provided under the Act and the Regulations made thereunder. If the category of foods as specified under Section 22 more particularly in Explanation (1), is sought to be monitored, controlled or regulated for the purpose of product approval by issuance of advisories by the Food Authority and that if such power to monitor, control or regulate is available under Section 16(1) read with Section 16(5) and the provisions of Section 18, it cannot be said that the Food Authority is acting arbitrarily or without any authority and power.
31. It is then contended on behalf of the petitioners that the Regulations framed under the Act do not provide for the concept of Product Approval. It is further contended that the petitioners have valid licences and therefore, to subject the petitioners to have a Product Approval as a condition ::: Downloaded on - 13/02/2014 23:11:32 ::: 109 WP2746.13 for renewal of their licenses or for registration of Food Business Operators, is an act which is outside the purview of the Licensing Regulations. It is contended that the impugned action on the part of the Food Authority to seek Product Approval from the existing licenced food manufacturers is ultra vires to the provisions of the Act and the Regulations. It is also contended that there is clear violation of Regulation 2.1.2 by imposing a procedure of product approval under the impugned advisory dated 11.5.2013. It is contended on behalf of the petitioners that such a procedure for product approval necessarily ought to have formed part of the regulations as contemplated under the provisions of sub-section (2) of Section 16 of the FSS Act. It is contended that this would entail exercise of powers by the Food Authority as per the requirements of Section 92 and Section 93 of the Act in as much as once such regulations are made they would be required to be placed before both the Houses of Parliament and then after the procedure as contemplated under Section 93 is followed, on the approval of both houses of Parliament such a rule would come into effect. It is contended that in view of this requirement of Section 92 and Section 93 the concept of product approval as being envisaged under the impugned advisory is rendered arbitrary and illegal and without any authority. These contentions on behalf of the Petitioners cannot be accepted. I have already observed hereinbefore that Section 16 sub-section (2) which provides that the Food ::: Downloaded on - 13/02/2014 23:11:32 ::: 110 WP2746.13 Authority 'may' by regulations specify different norms as contemplated in clauses (a) to (e) of Sub-section (2) would not bring about any embargo to the operation of Section 16 Sub-section (1). In other words, there is no fetter on the exercise of powers by the Food Authority under Section 16 Sub-
section (1) read with the provisions of Sub-section (5). Furthermore, Section 18 lays down the principles to be followed in the administration of the Act by various authorities including the Food Authority. A cumulative reading of these provisions leaves no manner of doubt that the provisions of Sections 92 and 93 cannot in any manner affect the exercise of the independent powers of the Food Authority as conferred under Section 16 sub-section (1) and sub-section (5) and Section 18. This contention on the part of the petitioners therefore, cannot be accepted. Depending on the situation prevailing from time to time, the Food Authority can always frame regulations for effective administration and management of the Act and to further the purpose and object it desires to achieve. However, it cannot be countenanced that only because the regulations are silent on the issue of product approval the Food Authority is rendered powerless to achieve its object to have 'approved food' available for human consumption which is of paramount consideration. Further it cannot be accepted that the subordinate legislation can control the operation of the substantive provisions. A licence is a creature of a Statute and necessarily involves compliance of all the ::: Downloaded on - 13/02/2014 23:11:32 ::: 111 WP2746.13 standards of food safety so as to conform from time to time the standards in relation to various ingredients as set down by all Food Authority. A licence holder cannot take a position contrary to this that a product approval is not acceptable to him when he has already subjected himself to Regulations 2.1.2. If an action is initiated by the Food Authority to achieve the purpose and object of the Act to provide safe and wholesome food products the licence provisions which are subservient to the substantive provisions cannot be taken recourse by the Petitioners to contend that in the absence of Regulations, the Food Authority would be without any authority and power to fulfill the requirements of Section 22 as sought to be achieved by the Food Authority by exercise of powers under Section 16(1) and Section 16(5) read with Section 18 of the FSS Act. Another aspect which is important in the present context is to appreciate that what is being dealt by the Petitioners is food having a direct nexus to the life and livelihood of a person. It is well settled that right to livelihood includes right to live with dignity.
Consumption of any substandard food would definitely affect the health of a person. In this context, the mandate of Article 21, Article 39 clause (e) and
(f) read with Article 47 of the Constitution cannot be overlooked. These constitutional provisions recognize the human right to have safe and wholesome food apart from the provisions of the FSS Act. If inferior and substandard food is supplied in the market, it would not only affect the ::: Downloaded on - 13/02/2014 23:11:32 ::: 112 WP2746.13 Society at large but it would definitely take away these valuable constitutional requirements. Hence, the submissions on the part of the petitioners that in the absence of specific Regulations or specific provisions in the Act the concept of Product Approval cannot be issued by the Food Authority, is devoid of any merit. Thus the right to do business in food under a licence cannot be placed on such high pedestal that it would take away the mandate of Article 21 read with Article 39 (e) and (f) and Article 47 of the Constitution. The licence to deal in food business necessarily would contemplate the fulfillment of the requirement of the said Constitutional mandate which is sought to be fulfilled by the Food Authority by bringing about a regime of 'approved food' to be made available for human consumption by introducing the concept of product approval.
Therefore, the petitioners' contention that in the absence of regulations qua product approval the Food authority cannot function is misconceived and cannot be accepted as this would defeat the purpose and object of the Act and the Constitutional requirement as aforesaid. The legislature has strengthened the hands of the Food Authority with sufficient provisions as discussed hereinabove and if such an authority and power is exercised while issuing the impugned advisory, the Food Authority is justified in so doing and this action cannot be said to be an illegal action or ultra virus the Act or regulations framed thereunder. It is for the Food Authority which is an ::: Downloaded on - 13/02/2014 23:11:32 ::: 113 WP2746.13 expert body to determine the requirements which are necessary to fulfill its objects for providing food safety and availability of wholesome food for human consumption. It would be inappropriate to accept a situation that due to want of some regulations to be framed, the Food Authority would be crippled to exercise its powers and duties that are reposed in it by the mandate of section 16 (1)(5), Section 18 and Section 22 of the Act read with the requirement to achieve the mandate of Article 21 read with section 39
(e) and (f) and Article 47 of the Constitution. The contention of the petitioners that powers must be exercised in a manner it is conferred and in no other manner therefore cannot be accepted in the present context.
It is further clear that the Food Authority had issued the first Advisory on the 'Product Approval' on 30.1.2012 and thereafter has been consistently insisting on the product approval requirement as is clear from the subsequent advisories dated 14.2.2012, 22.3.2012, 6.8.2012, 10.9.2012, 26.10.2012, 26.10.2012, 11.12.2012, 5.2.2013, and 11.5.2013. Further nothing is placed on record by the petitioners to show any resistance on the part of any of the petitioners on the product approval procedure. In fact it appears from the documents annexed as Exhibit E to the Writ Petition that in fact application for product approval was made. It therefore, appears from the record that the petitioners have not seriously disputed the Advisories issued from time to time and in fact have accepted the same. If such is the ::: Downloaded on - 13/02/2014 23:11:32 ::: 114 WP2746.13 conduct on the part of the petitioners in showing their willingness to the concept of product approval, it deserves to be appreciated, as it would be a step on the part of the Food manufacturers to support the cause of healthy and wholesome food available to the society of which they are an integral part. Strangely the conduct of the petitioners appears to be an absolute paradox as seen from the legal issues as raised in the present petition.
Moreover, in such a situation, a demand for mandamus as per the requirement of law cannot stand and the petition ought to fail on this count as well. As observed above the Food Authority is not immobilized in the absence of regulations from functioning under the statute. There is no embargo on the powers of the Food Authority to fill in the gaps in the regulations. It is very well within its powers to issue the impugned Advisory as per the mandate of Section 16 sub-section (1) read with sub-section (5) to achieve the object and principles enumerated under Section 18 of the Act.
Only on such exercise of power, Section 16 (1), (5) and Section 18 become meaningful. It cannot be said that if such an exercise is undertaken the same becomes inconsistent with the provisions of the Act or regulations. It is clear that the guidelines under the impugned Advisory are eminently issued in public interest and towards the fulfillment of the object and purpose of the Act. Once such an authority has been conferred on the Food Authority to carry out the policy and purpose of the Act, it cannot be accepted that the ::: Downloaded on - 13/02/2014 23:11:32 ::: 115 WP2746.13 authority has acted arbitrarily or the impugned action on the part of the Food Authority to issue the Advisory dated 11.5.2013 is ultra vires.
32. It was then contended on behalf of the petitioners that the word "may" appearing in Section 16(2) shall be read as "shall" inasmuch as it would be obligatory on the Food Authority to have Regulations framed in respect of any product approval as being sought by impugned advisory or in other words the impugned advisory not being contemplated under the regulations, the same becomes ultra vires and illegal. In my opinion, this argument cannot be accepted for the reasons that the context in which the word "may" has been referred, cannot be read to be "shall" as desired by the petitioners, inasmuch as the provisions of sub-section (2) of Section 16 in no manner can influence the operation of the provision of sub-section (1) of Section 16 which confers independent power on the Food Authorities to do several acts so as to ensure safe and wholesome food, read with further specific power as conferred under sub-section (5) of Section 16. It is well settled that the word "may" can never be construed as mandatory if such construction is to defeat the purpose and object of the Act or if such construction would lead to unjust result. If such construction as contended by the Petitioner is accepted it would defeat the paramount purpose and object for which the legislation stands. Even if the word "may" is construed to be ::: Downloaded on - 13/02/2014 23:11:32 ::: 116 WP2746.13 "shall" as used in sub-section (2) of Section 16 (which does not in my view), it cannot abdicate the operation, object and the rigour of sub-section (1) of section 16 as also sub-section (5) of section 16. It is further not acceptable that only because the regulations do not contemplate a procedure for product approval, the Food Authority is abdicated of its power to bring out a regime of only approved products available for human consumption which it can fulfill from the abundant powers as available under Sections 16(1), 16(5) read with Sections 18 and 22. Such construction as contended on behalf of the petitioners in the present context would defeat the substantive provisions of the FSS Act.
33. The learned Counsel for the Food Authority has drawn the attention of the Court to the recent judgment of the Supreme Court (referred at page 25 of the Affidavit in reply of the Food Authority) in the case of "Centre for Public Interest Litigation Vs. Union of India & Ors. (NOW reported in AIR 2014 SC 49)". In the context of an issue dealing with the harmful effect of soft drinks on human health and in considering the provisions of FSS Act on various principles of food safety as enshrined in Section 18 and other provisions of the Act, the Supreme Court has held that 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 ::: Downloaded on - 13/02/2014 23:11:32 ::: 117 WP2746.13 fundamental right guaranteed to the citizens under Article 21 read with Article 47 of the Constitution of India. It is 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 read with Article 47 of the Constitution of India. It is held that the provisions of FSS Act and the Rules and Regulations framed thereunder are required to be interpreted and applied in the light of the Constitutional principles and an endeavour has to be made to achieve appropriate level of protection of human life and health.
It is held that considerable responsibility is cast on the Authorities as well as other officers functioning under the Act to achieve the desired results. It is also held that the parties are also obliged to maintain a system of control and other activities as appropriate to the circumstances, including public communication on food safety and risk, food safety surveillance and other monitoring activities covering all stages of food business. It would be profitable to reproduce the relevant paragraphs of the said judgment of the Supreme Court in the present context.:-
"19. Article 21 of the Constitution of India guarantees the right to live with dignity. The right to live with human dignity denies the life breach from the Directive Principles of the State Policy, particularly clauses (3) and (f) of Article 39 read with Article 47 of the Constitution of India.
Article 47 reads as follows:-
"47. Duty of the State to raise the level of nutrition and the standard of living and to improve public health. The State shall regard the raising of the level of nutrition and the standard of living of its people and the improvement of public health as among its primary duties and, in particular, the State shall ::: Downloaded on - 13/02/2014 23:11:32 ::: 118 WP2746.13 endeavour to bring about prohibition of the consumption except for medicinal purposes of intoxicating drinks and of drugs which are injurious to health."
20. Article 12 of the International Covenant on Economics, Social and Cultural Rights,1966 reads as follows:-
"12-(1) The States Parties to the present Covenant recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.
(2) The steps to be taken by the States Parties to the present Covenant to achieve the full realization of this right shall include those necessary for:
(a) The provision for the reduction of the still birth-rate and of infant mortality and for the healthy development of the child;
(b) The improvement of all aspects of environmental and industrial hygiene;
ig (c) The prevention, treatment and control of epidemic, endemic, occupational and other diseases;
(d) The creation of conditions which would assure to a medical service and medical attention in the event of sickness."
21. We may emphasize 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.
22. We are, therefore, of the view that the provisions of the FSS Act and PFA Act and the rules and regulations framed thereunder have to be interpreted and applied in the light of the Constitutional Principles, discussed above and endeavour has to be made to achieve an appropriate level of protection of human life and health. Considerable responsibility is cast on the Authorities as well as the other officers functioning under the above-mentioned Acts to achieve the desired results. Authorities are also obliged to maintain a system of control and other activities as appropriate to the circumstances, including public communication on food safety and risk, food safety surveillance and other monitoring activities covering all stages of food business.
23. Enjoyment of life and its attainment, including right to life and human dignity encompasses, within its ambit availability of articles of food, without insecticides or pesticides residues, ::: Downloaded on - 13/02/2014 23:11:32 ::: 119 WP2746.13 veterinary drugs residues, antibiotic residues, solvent residues, etc. ---- --- --- ----" (emphasis supplied)
34. It is thus seen from the aforesaid binding principles as laid down by the Supreme Court that it is not only a statutory requirement for the food Authorities to have a regime of safe food products to be made available to the consumer but a constitutional requirement emanating from the provisions of Article 21 read with Article 39 and 47 of the Constitution of India.
35. It cannot be overlooked that if a discipline to recognize access to ample and nutritious food as a part of requirement of fulfillment of human rights is being achieved by the Food Authority, such an effort cannot be scuttled on such rigid technicalities as canvassed by the Petitioners. In the present context, human rights are paramount and food is a vital issue affecting human rights at all levels. It is well settled that right to livelihood would encompasses right to live with dignity i.e. to have healthy life which is possible only if safe and wholesome food is available for human consumption. It cannot be overlooked that the issue of food safety and right to have wholesome food is a matter of national as well as international concern. A right to safe food being part of the right to livelihood is the requirement of Article 21 of Constitution of India as held by the Supreme ::: Downloaded on - 13/02/2014 23:11:32 ::: 120 WP2746.13 Court. Therefore, there is nothing improper on the part of the Food Authority to bring about a regime to have a concept of Product Approval for existing licence holders or in relation any food business.
36. In view of the foregoing reasons, the impugned food advisory dated 11.5.2013 as also the other food advisories issued from time to time are clearly within the ambit of the authority and power conferred on the Food Authority under the provisions of Section 16(1) read with Section 16(5) and Sections 18 and 22 of FSS Act and further the Food Authority is justified in having the concept of Product Approval which in fact is a recognition and implementation of the mandate of human rights and right to livelihood as falling under Article 21 read with clauses (e) and (f) of Article 39 and Article 47 of the Constitution.
37. In these circumstances, the writ petition fails and is accordingly rejected.
38 No order as to costs.
(GIRISH S.KULKARNI, J.) ::: Downloaded on - 13/02/2014 23:11:32 ::: 121 WP2746.13 In view of difference of opinion between us on the issue involved in this matter, the following order is passed:-
ORDER Office is directed to place this matter before the Hon'ble Chief Justice so that the issues framed below can either be referred to a third judge or larger Bench:-
(1) Whether the impugned Advisories which have been issued by Respondent No.2 have the force of law and are within the ambit and scope of the power conferred on Respondent No.2 - Food Authority under the provisions of the said Act and the Rules and Regulations framed thereunder?
(2) Whether Respondent No.2 - Food Authority had the power and authority to issue these Advisories under section 16(1) read with section 16(5) read with sections 18 and 22 of the said Act without following the procedure laid down under sections 92 and 93 of the Act of placing the Advisories/Regulations before both the Houses of Parliament?
(GIRISH S. KULKARNI, J.) (V.M. KANADE, J.)
::: Downloaded on - 13/02/2014 23:11:32 :::