Bombay

Hig

h Court

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 )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 - 03/04/2014 11:12:49 :::

Bombay

Hig

h Court

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: 22-01-2014Judgment 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 - 03/04/2014 11:12:49 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:49 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:49 :::

Bombay

Hig

h Court

5

WP2746.13

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 - 03/04/2014 11:12:49 :::

Bombay

Hig

h Court

6

WP2746.13

“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 12th

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 - 03/04/2014 11:12:49 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:49 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:49 :::

Bombay

Hig

h Court

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.

11. It will be necessary to consider the Scheme of the FSS

Act, 2006. 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 - 03/04/2014 11:12:49 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:49 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:49 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:49 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:49 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:49 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:49 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:49 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:49 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:49 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:49 :::

Bombay

Hig

h Court

20

WP2746.13

“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 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

::: Downloaded on - 03/04/2014 11:12:49 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:49 :::

Bombay

Hig

h Court

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 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 - 03/04/2014 11:12:49 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:49 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:50 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:50 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:50 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:50 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:50 :::

Bombay

Hig

h Court

29

WP2746.13

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 - 03/04/2014 11:12:50 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:50 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:50 :::

Bombay

Hig

h Court

32

WP2746.13

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 1972 Ibid: Rangaswami, Textile Commissioner vs. Sagar Textile Mills (P.) Ltd, AIR 1977

SC 1516, p. 1517: (1977) 2 SCC 578

::: Downloaded on - 03/04/2014 11:12:50 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:50 :::

Bombay

Hig

h Court

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 case, perusal of the said

guidelines/circular/advisory reveals that procedure 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 - 03/04/2014 11:12:50 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:50 :::

Bombay

Hig

h Court

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

Power in the wrong hands

Closely akin 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 - 03/04/2014 11:12:50 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:50 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:50 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:50 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:50 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:50 :::

Bombay

Hig

h Court

42

WP2746.13

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 28 th January, 2014

Pronounced on 4 th 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 - 03/04/2014 11:12:50 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:50 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:50 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:50 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:50 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:50 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:50 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:50 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:50 :::

Bombay

Hig

h Court

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

(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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 notrepresented 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 Drugsand 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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 i ssue of licensing of milk and milk products .

(VIII) Advisory on r efused gelatine contaminated with clostridium

difficile from US FDA.

::: Downloaded on - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 u se 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.

2.

3.

5.7.2011

1.3.2012

Advisory regarding renewal/transfer of licence during transition period

Appointment of food Inspectors employed by the Municipal Corporations/Councils, as the Food Safety Officer and Designated officer under the provisions of Food Safety & Standards Act,2006.

::: Downloaded on - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

70

WP2746.13

4.

5.

6.

24.1.2012

23.3.2012

2.4.2012

Issue of licensing of FBO at Airports & Ports

Issue of State/Central Licensing – Clarification on jurisdiction.

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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

79

WP2746.13

“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 31st 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. 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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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. 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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:51 :::

Bombay

Hig

h Court

85

WP2746.13

(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 - 03/04/2014 11:12:52 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:52 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:52 :::

Bombay

Hig

h Court

88

WP2746.13

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 - 03/04/2014 11:12:52 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:52 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:52 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:52 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:52 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:52 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:52 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:52 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:52 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:52 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:52 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:52 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:52 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:52 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:52 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:52 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:52 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:52 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:52 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:52 :::

Bombay

Hig

h Court

108

WP2746.13

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 - 03/04/2014 11:12:52 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:52 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:52 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:53 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:53 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:53 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:53 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:53 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:53 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:53 :::

Bombay

Hig

h Court

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;

(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 - 03/04/2014 11:12:53 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:53 :::

Bombay

Hig

h Court

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 - 03/04/2014 11:12:53 :::

Bombay

Hig

h Court

121

WP2746.13

In view of difference of opinion between us on the issue involved in

this matter, the following order is passed:-

O R D E R

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 - 03/04/2014 11:12:53 :::