FULL PAPER ON

FOOD REGULATORY SCENARIO: A PARADIGM SHIFT

By,
Prasanna Kumar M.R and Bharath.R
Jr MBA (ABM)

DEPARTMENT OF AGRICULTURAL MARKETING, COOPERATION

AND BUSINESS MANAGEMENT
 FOOD REGULATORY SCENARIO: A PARADIGM SHIFT
Bharath R1* and Prasanna Kumar2*
Agmaco Student, Dept. of Ag. Marketing & Business Management
UAS, GKVK, Bangalore – 560065
*Email: bharath.ramaiah@gmail.com and prasu_mk612@yahoo.co.in

Every country has its own food laws. Its is important for every
manufacturer, exporter or importers adhere to the rules of the land for food
products as it effects health of population. In India multiple regulations for food
have been enacted at different points of time to supplement each other. This
incremental approach has led to incoherence and inconsistency in the food sector
regulatory scenario. The Food Safety and Standards Act, 2006 is a new statute
that integrates eight different existing food laws, and is a major transformation
that ensures to bring paradigm shift in the food regulatory scenario of the
country. Severe penalties are provided for any violation of these laws. This
could also result in bad publicity and in worst case closure of the plant. Hence its
is important for the manufacturer, importers and exporters to adhere to these
laws. The Indian food industry appreciates the benefits of the Act and look
forward to its effective implementation.

Topic : Food laws and regulations

 FOOD REGULATORY SCENARIO:
A PARADIGM SHIFT

Introduction:

The food processing industry is one of the largest sectors in India in terms
of production, growth, consumption and export. Food processing industry
is widely recognized as the 'sunrise industry' in India and is of enormous
significance for India’s development because of the vital linkages and
synergies that it promotes between the two pillars of the economy,
namely Industry and Agriculture. As the country moves on the path of
development, agricultural sector evolves from traditional level farming to
commercial agriculture producing high value and processed products.

The Indian food regulations comprise various food laws that have been
enacted at different points of time, and are under the ambit of various
ministries of Government of India (GOI). Historically, these were
introduced to complement and supplement each other in ensuring total
food safety and quality. As a result the food sector in India is governed by
a number of different statutes rather than a single comprehensive
enactment. Each ministry has prescribed its set of rules and standards
under relevant acts and orders often creating confusing and sometimes
contradictory signals to the industry.

The multiplicity of ministries and administering authorities at both the

central and state level has resulted in a complex regulatory system that is
not well integrated adding an additional burden on the food industry. In
general, this regulatory system resulted in a lack of comprehensive,
integrated food law under single regulatory authority that ensures public
health, safety, and also specifies quality norms for meeting the globally
recognized standards.
Important parameters of food Laws are:

 Shelf life of the products

 Permissible limits of chemical/additives  in foods
 Quality and specification of  packaging
 Labelling
 Manufacturer details
 Local and international standards - health certificates
 General Hygiene
 Proper export /Import Documents
 Laws for storage and transportation.

Important Food laws and regulation in India 

 
Foods laws are enacted by various ministries through parliament apart
from central government laws various states have their own food laws.
Following are the important Acts enacted by Government of India:

 Food Safety and Standards Act, 2006

 Prevention of Food Adulteration Act (PFA) 1954 and Rules (Ministry
of Health & Family Welfare)
 The Standards of Weights and Measures Act, 1976
 Standards of Weights and Measures (Packaged Commodities) Rules,
1977
 Agriculture Produce (Grading & Marking) Act (Ministry of Rural
Development).
 Essential Commodities Act, 1955(Ministry of Food & Consumer
Affairs)
 Fruit Products Order (FPO), 1995
 Meat Food Products Order, 1973 (MFPO)
 Milk and Milk Products Order, 1992
  The Infant Milk Substitutes, Feeding Bottles and Infant Foods
(Regulation of Production, Supply and Distribution) Act, 1992 and
Rules 1993
 The Insecticide Act, 1968
 Export (Quality Control and Inspection) Act, 1963
 Environment Protection Act, 1986; Pollution Control (Ministry of
Environment and Forests)
 Industrial Licenses, BIS Act, 1986
 VOP (Control) Order -1947
 SEO (Control) Order -1967

Food safety laws:

In India multiple regulations for food have been enacted at different

points of time to supplement each other. This incremental approach has
lead to incoherence and inconsistency in the food sector regulatory
scenario. A number of committees, including the Standing Committee of
Parliament on Agriculture in its 12th Report submitted in April 2005, have
emphasized the need for a single regulatory body and an integrated food
law.

To this effect, The Food Safety and Standards Act, 2006 consolidated
eight laws governing the food sector and established the Food Safety and
Standards Authority (FSSA) to regulate the sector. The Food Safety and
Standards Act, 2006, aimed to integrate the food safety laws in the
country in order to systematically and scientifically develop the food
processing industry and shift from a regulatory regime to self-compliance.

However, the key problem that industry anticipates from implementation

of the Act is the initial phase of disorder that will be introduced. FICCI
survey has identified implementation bottlenecks in food safety
laws as the third critical area of concern for the food processing
sector, with 28.51% of weighted responses. The small and medium
scale industries that do not vigorously keep track of the regulatory
changes will find it difficult to identify the procedural and compliance
changes brought by the Act.

Food Safety and Hygiene Standards in India

Safety and hygiene is very important area in any food industry. Food
factories should have basic good housekeeping and hygiene standards as
any lack in this area would result in very poor performance of the
business. This is also important as the Consumers are very sensitive to
foreign body complaints or anything which might affect individuals’
health. State governments have imposed strict quality parameter for
ingredients and their storage practices. Food safety in bakery industry has
certain features which are different from other food factories. The
consumers have become educated on food safety standards and health
safety, and as a result Governments have responded with more laws on
food safety. 

The Food Safety and Standards Act, 2006:

Following pressure from the industry and stakeholders for a single

regulatory body and an integrated modern food law, the then Prime
Minister of India in 2002 constituted a task force to review India’s food
and agro industries management policy. The task force made wide-
ranging recommendations among which one of the major
recommendations was the consolidation of the various food laws under
one umbrella, setting up a food regulatory authority somewhat akin to
U.S. Food and Drug Administration, urgent need to align Indian food
standards to international standards, and that the government and
industry should work together to ensure that India is well represented and
fully heard in international forums like Codex Alimentarius Commission.
The Bill was introduced in the LokSabha (Lower house) on August 25,
2005, and was referred to the Parliamentary Standing Committee (PSC)
on Agriculture for further review and scrutiny. The PSC presented its
report to the Parliament on February 21, 2006.  The LokSabha passed the
Bill after incorporating the PSC’s recommendations on July 26, 2006. The
Bill, as passed by LokSabha was presented in the RajyaSabha (Upper
house) on the July 31, 2006.  The Bill was passed on the August 2, 2006.
The President of India signed the Bill on August 23, 2006 and was finally
enacted as, The Food Safety and Standards Act, 2006 (No. 34 of 2006).
The GOI notified the enactment in the official gazette on August 24, 2006.

The Food Safety and Standards Act, 2006 (the Act) has 12 chapters
containing 101 sections and two schedules. The Act incorporates the
salient provisions of the Prevention of Food Adulteration Act 1954, and is
based on international legislations, instrumentalities and Codex
Alimentarius Commission. This Act with its three tier structure (an apex
food safety and standards authority, a central advisory committee and
various scientific panels and committees) is expected to lay more
emphasis on science based and participatory decisions while adopting the
contemporary approach in both standard setting and implementation.

Salient features of the Act

This presentation provides a brief overview of the salient features of the

Act.
 The Act integrates eight different food related statutes by moving
from multi-level, multi-departmental control to a single line of
command.
 The Act establishes the Food Safety and Standards Authority of
India (FSSAI) as an apex regulatory authority consisting of a
Chairperson and 22 members.
 The Act prescribes general provisions for the following articles of
food:
 Food additives / processing aids are to be added only in
accordance with provisions / regulations under the Act;
 Foods are not to contain any insecticides or pesticides residues,
veterinary drugs residues, antibiotic residues, solvent residues,
pharmacological active substances and micro-biological
contaminants in excess of limits prescribed under the regulation;
 Regulations to be made for the manufacture, distribution or trade
of any novel foods, genetically modified foods,irradiated foods,
organic foods, foods for special dietary uses, functional foods,
nutraceuticals, health supplements, proprietary foods, etc.
 The Act provides the general administrative principles to be followed
by the Central Government, State Governments, and FSSAI while
implementing the provisions of this Act.
 The Act prohibits advertisements which are misleading or deceiving
or contravenes the provisions of this Act, and prohibits unfair trade
practices.
 All imports of articles of food are subject to this Act.  No person
shall import any unsafe or misbranded or sub-standard food or food
containing extraneous matter.
 The Act impose the responsibility on the food business operator to
ensure that the articles of food satisfy the requirements of this Act
at all stages of production, processing, import, distribution and sale
within the businesses under his control.
 The Act also imposes certain liabilities on the manufacturers,
packers, wholesalers, distributors and sellers if an article of food
fails to meet the requirements of this Act.
 The Act compels the establishment of food recall procedures.
 The FSSAI and the State Food Safety Authorities are responsible for
the enforcement of this Act. The Act establishes a general authority
line for the efficient enforcement of the Act.
  The Act compel licensing and registration of food business. Small
business operators and temporary stall holders are exempted from
the license but need to get their businesses registered with the local
municipality.
 The Act provides general provisions relating to offences and
penalties for failure to comply with the requirements of this Act. The
Act makes provision for graded penalties where offenses like
manufacturing; storing or selling misbranded or sub-standard food
is punished with a fine, and more serious offences with
imprisonment.

FSSAI Constitution

The FSSAI consists of a chairperson and 22 members, of which one-third

shall be women. In their endeavor to carry out provisions of the Act, the
FSSAI shall be assisted by Central Advisory Committee (CAC), Scientific
Panels (SPs) and Scientific Committee (SC) each with specific
responsibilities for drawing up proposals for the FSSAI’s work program,
prioritization of work, identifying potential risks, pooling of knowledge,
ensuring co-operation between the FSSAI and the enforcement agencies,
and other functions as specified by the regulations.

Duties and functions of the FSSAI

 Framing of regulations to lay down the standards and guidelines in

relation to the articles of food, and specifying appropriate system of
enforcing various standards thus notified.
 Laying down mechanisms and guidelines for accreditation of
certification bodies engaged in certification of food safety
management system for food businesses.
 Laying down procedure and guidelines for accreditation of
laboratories and notification of the accredited laboratories.
  Provide scientific advice and technical support to central
government and state governments in framing policy and .
 Prescribe the food-labeling standards including claims on health,
nutrition, special dietary uses and food category systems for foods.
 Prescribe the procedure subject to which risk analysis, risk
assessment, risk communication and risk management shall be
undertaken.
 Creating an information network across the country to disseminate
rapid, reliable and objective information about food safety and
issues of concern.
 Provide training programs for persons who are involved or intend to
get involved in food businesses.
 Contribute to the development of international technical standards
for food, sanitary and phyto-sanitary standards.
 Promote general awareness about food safety and food standards.
 Promote co-ordination & consistency of work on food standards
undertaken by international governmental & non-governmental
organizations.

Status on enforcement of the Act:

The administrative control of the Act is assigned to the Ministry of Health

and Family Welfare.   On September 5, 2008, the GOI notified the
establishment of FSSAI consisting of a chairman and members who in
turn will initiate the rule making process. Certain provisions of the Act are
enforced steadily and are notified by the GOI. FSSAI constituted the SC
and SPs, and established its administrative process.

An amendment to the Act, called the Food Safety and Standards

(Amendment) Act, 2008 (No. 13 of 2008) was recently enacted. This is an
amendment providing an exemption to the members of FSSAI from the
purview of office of profits and the age restriction to a maximum of 62
years. FSSAI is steadily drafting the draft guidelines and regulations for
public consultation.

Key benefits of the Act:

 One of the major benefits of implementation of the Act will be the

consolidation of the existing eight laws relating to food and
establishment of the FSSAI.
 Foods for special dietary uses or nutraceuticals or functional foods
or health supplements is a category that has been specifically
defined in the Act, a feature which was not there in existing food
laws.
 The implementation of the Act is anticipated to facilitate and
promote the development of new products thus enabling the growth
of the industry and innovation.

Key issues, and anticipated implementation problems:

 The key problem that industry anticipates from implementation of

the Act is the initial phase of disorder that will be introduced.
 The small and medium scale industries that do not very vigorously
keep track of the regulatory changes will find it difficult to identify
the procedural and compliance changes brought by the Act.
 Industry is also apprehensive that during the transition phase,
uncertainty will prevail till the food processing industries and the
regulators can come to a common platform.
 A comprehensive study report prepared for MOFPI reported that
majority of the laboratories in India do not have accreditation, and
only few laboratories are fully equipped to cater the domestic and
export regulatory testing needs of the food industry as heavy
penalties for non-conformances is emphasized.
  The report also emphasized a greater need of manpower
development and up gradation of the laboratories in terms of
infrastructure and sophisticated equipments.
 With the advent of the Act that will levy heavy penalties for non-
conformances, a need for accredited laboratories is of paramount
importance.
 Industry anticipate that shortage of testing laboratories and
equipment might hamper the implementation of the Act, and GOI
may also find it difficult to identify, recruit and then continually train
people for the accredited laboratories.
 The immediate adoption of international standards, without
preparing the domestic food industry will pose challenges for the
effective implementation of the Act.
 The Act also mentions certain terms like 'Food Safety Management
System' whose definition calls for adoption of 'Good Manufacturing
Practices', 'Good Hygienic Practices' and 'Hazard Analysis and
Critical Control Point'.
 The Act excludes plants prior to harvesting and animal feed from its
purview.
 Though standards are specified for water used as an input in
manufacture/preparation of food, the Act does not require any
specific standards for potable water.

Conclusion

The food sector in India has been governed by multiple laws enacted at
different points of time to complement and supplement each other under
different ministries.

The Food Safety and Standards Act, 2006 is a major transformation that
has happened after decades and ensures to bring a paradigm shift in the
food regulatory scenario of the country. As part of the process of
consolidation, the eight contradicting and overlapping food laws in the
country would stand repealed on commencement of this Act. This unified
Act will enable unidirectional compliance and address the need for a single
regulatory body. In the new Act, called the Food Safety and Standards
Act, 2006, the emphasis is more on an advisory role than policing. The
new law also brings about a single window license system.

Implementation of the Act is a mammoth task not only for the food
processing industries but also for the GOI to incorporate the proposed
changes in the existing structure and functioning of the government
machinery. To fully realize the benefits of the Act, FSSAI needs to
maintain total transparency in rule framing. Involvement of industry and
other stakeholders at the earliest stages of rule framing and transparent
public consultation, directly or through representative bodies, during the
preparation, evaluation and revision of food law is essential for setting of
sound scientific standards.