According to the advisory issued under the Food Safety and Standards Act, 2006, food products covering a broad spectrum including 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 etc should apply for product approval. Rejecting the contentions of the petitioner, the Court stated that ample and nutritious food as a part of requirement of fulfillment of human rights was being achieved by the Food Authority and such an effort could not be scuttled on rigid technicalities. Right to safe and uncontaminated food was held to be a fundamental right under the constitution and that there was 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. The judge added that it was well settled that the right to livelihood encompasses the right to live with dignity i.e. to have a healthy life which is possible only if safe and wholesome food was available for human consumption and it cannot be overlooked. [Vital Nutraceuticals Private Limited vs. Union of India, Writ Petition No. 2746 of 2013, decided on February 4, 2014]1
Bombay High Court
IN THE HIGH COURT OF JUDICATURE AT BOMBAY
ORDINARY ORIGINAL CIVIL JURISDICTION
WRIT PETITION NO.2746 OF 2013
CORAM : V.M.KANADE AND
GIRISH S.KULKARNI, JJ.
Pronounced on : 4th February,2014
JUDGMENT : (PER: G.S.KULKARNI, J.)
1. I have had the privilege of going through the erudite judgment
of my learned brother Mr.Justice V.M.Kanade. Having deliberated over the
arguments advanced by the learned Counsel for contesting parties in the
light of the statutory provisions and authoritative pronouncement of the
Supreme Court, I deeply regret my inability to persuade myself to share the
view of my learned brother. Hence, this Judgment.
2. Rule. Rule is made returnable forthwith. By consent of
parties , heard finally.
3. By this petition filed under Article 226 of the Constitution of
India, two petitioners viz. Vital Nutraceuticals Private Ltd.-Petitioner no.1
and Indian Drug Manufacturers' Association-Petitioner no.2 having 690
members as listed in the Statement annexed at 'Exhibit C' to the petition,
have inter alia challenged the action of Respondent no.2 viz. Food Safety
and Standards Authority of India (hereinafter referred to as 'the Food
Authority') in issuing advisories in respect of various issues falling under the
Food Safety and Standards Act,2006 and more particularly the advisory
dated 11.5.2013 which lays down the guidelines to be followed for the
'Product Approval Procedure'. The challenge has been confined to this
advisory.
4. The facts relevant for adjudication of dispute in the present
proceedings are as under:-
The Parliament enacted the Food Safety and Standards
Act,2006 (hereinafter referred to as “FSS Act,2006”) repealing the
Prevention of Food Adulteration Act,1954, the Fruit Products Order,1955,
the Meat Food Products Order,1973, the Vegetable Oil Products (Control)
Order,1947, the Edible Oils Packaging (Regulation) Order,1998, the Solvent
Extracted Oil, De oiled Meal, and Edible Flour (Control) Order,1967, the
Milk and Milk Products Order,1992, any other orders issued under the
Essential Commodities Act,1955 relating food. All these repealed Acts and
Orders are enumerated in the Second Schedule of the FSS Act forming part
of the repeal provision being Section 97 of the FSS Act. The preamble of
the FSS Act recites that it is an Act to consolidate the laws relating to food
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and to establish the Food Safety and Standards Authority of India for laying
down science-based standards for articles of food and to regulate their
manufacture, storage, distribution, sale and import, to ensure availability of
safe and wholesome food for human consumption and for matters connected
therewith or incidental thereto.
5. The Statement of Objects and Reasons of the FSS Act inter-alia
sets out in detail that the then Member-Secretary, Law Commission of India,
was asked to make a comprehensive review of Food Laws of various
developing and developed countries and other relevant international
agreements and instruments on the subject. That after making an indepth
survey of the International scenario, the then Member- Secretary
recommended that the new Food Law be seen in the overall perspective of
promoting nascent food processing industry given its income, employment
and export potential. That it has been suggested that all acts and orders
relating to food be subsumed within the proposed integrated Food Law as
the international trend is towards modernization and convergence of
regulations of Food Standards with the elimination of multi-level and multidepartmental
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
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Analysis and Critical Control Point. It further recites that in this
background, the Group of Ministers constituted by the Government of India,
held extensive deliberations and approved the proposed Integrated Food
Law with certain modifications. The Integrated Food Law was named as
“The Food Safety and Standards Bill,2005”. That the main object of the
Bill was to bring out a single statute 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 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/
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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.”
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 subsection
(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
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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 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
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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;
(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 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
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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 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
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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 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;
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(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
(vi) introduction of rapid alert system;
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(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 cooperation
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 protection adopted in the country is not reduced; and
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(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
achieve the general objectives of regulations;
(c) where in any specific circumstances, on the basis of
assessment of available information, the possibility of harmful
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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
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;
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(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,
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
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nutraceuticals or health supplements” means:
(a) foods which are specially processed or formulated to satisfy
particular dietary requirements which exist because of a particular
physical or physiological condition or specific diseases and
disorders and which are presented as such, wherein the
composition of these foodstuffs must differ significantly from the
composition of ordinary foods of comparable nature, if such
ordinary foods exist, and may contain one or more of the
following ingredients, namely:-
(i) plants or botanicals or their parts in the form of powder,
concentrate or extract in water, ethyl alcohol or hydro alcoholic
extract, single or in combination;
(ii) minerals or vitamins or proteins or metals or their compounds
or amino acids (in amounts not exceeding the Recommended
Daily Allowance for Indians) or enzymes (within permissible
limits);
(iii) substances from animal origin;
(iv) a dietary substance for use by human beings to supplement
the diet by increasing the total dietary intake;
(b) (i) a product that is labelled as a “Food for special dietary uses
or functional foods or nutraceuticals or health supplements or
similar such foods” which is not
represented for use as a conventional food and whereby such
products may be formulated in the form of powders, granules,
tablets, capsules, liquids, jelly and other dosage forms but not
parenterals, and are meant for oral administration;
(ii) such product does not include a drug as defined in clause (b)
and ayurvedic, sidha and unani drugs as defined in clauses (a) and
(h) of section 3 of the Drugs
and Cosmetics Act, 1940 (23 of 1940) and rules made thereunder;
(iii) does not claim to cure or mitigate any specific disease,
disorder or condition (except for certain health benefit or such
promotion claims) as may be permitted by the regulations made
under this Act;
(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
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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 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
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food for human consumption or affecting the health of the consumers. Subsection
(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 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.
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11. Section 91 provides for the powers of the Central Government
to make rules inter-alia on the various matters 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 (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
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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
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
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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 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
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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. Subregulation
(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 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
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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
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
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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.
(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
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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.
4.
5.
6.
5.7.2011
1.3.2012
24.1.2012
23.3.2012
2.4.2012
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.
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”:-
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(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
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
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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
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
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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
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
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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 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
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assessment has not been carried out. It is stated that in such cases the
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
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introduced for the first time into the country need to apply for product
approval before applying for 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
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licenses previously under the Acts or 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
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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:-
“1. Foods or food categories covered under the NPA
procedure and required to obtain product approval:
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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)
ii. The FBO shall also declare the category
under which he intends to market the product as
specified under Section 22 – namely food supplement,
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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 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
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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
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
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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
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.
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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
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.
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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:-
(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
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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 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
impugned advisory is per-se beyond the purview and scope of the
regulations, hence ultra vires.
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(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.
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
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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 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
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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 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 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
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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 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
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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
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
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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 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,
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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 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
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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 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 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
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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 stakeholders
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 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,
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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 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,
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sale or import of such category of food. The intention of the said 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
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
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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,
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
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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 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
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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 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
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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 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
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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 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
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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.
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
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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 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
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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 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 Subsection
(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
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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 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
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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 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
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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 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,
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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
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
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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
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
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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 “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
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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
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.
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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
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 birthrate
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.
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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,
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
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.)
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