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ASSESSING FOOD LAWS AND REGULATIONS:
A COMPARATIVE STUDY OF INDIA, UNITED KINGDOM &
THAILAND
COURSE: FOOD LAWS & LEGISLATION (APFE-614)
Study report submitted
under the guidance of
Er. Hena Imtiyaz & Er. Avanish Kumar
(Assistant Professors, Dept of Food Process Engg.)
by
Abdul Rehman (ID 16BTFT070)
in the
partial fulfilment
of
the award of degree
of
Bachelor of Technology in Food Technology
Department of Food Process Engineering
Vaugh Institute of Agricultural Engineering and Technology
Sam Higginbottom University of Agriculture, Technology and Sciences
May 2020
2
ACKNOWLEDGEMENTS
It is with immense pleasure I would like to express our deep sense of gratitude and sincere
thanks to all the people whose combined efforts results in completion of task.
To start with, I would like to present my deep gratitude to Er. Hena Imtiyaz & Er. Avanish
Kumar (Assistant Professors, Department of food Process Engineering, SHUATS) who
gave the opportunity to gain knowledge on food laws and regulations by drafting special report
on Comparative assessment of food laws in India, UK & Thailand.
I would also thank Prof. (Dr.) Sheen Moses (Head, Dept of Food Process Engineering,
SHUATS) and University Academic Council for giving their kind decision towards student
welfare in this crucial time when the whole world is suffering from pandemic with no positive
signs till date.
Lastly, I am obliged to my parents for their blessings & love and the support without which
this target could not be accomplished.
ABDUL REHMAN
3
ABSTRACT
Food regulations and standards in the leading countries are highly developed, and are perceived
to be more stringent, based on scientific risk management and proactive introduction of new
regulatory standards for previously unknown or unregulated hazards. Every nation needs an
effective food legislation and food control service to promote a safe, honestly presented food
supply, and to protect consumers from contaminated, adulterated, and spoiled foods.
Indian laws concerning standards of food and its manufacture, sale and import were overhauled
in the year 2006. Encompassed primarily in the Food Safety and Standards Act, 2006 (FSS
Act) and related Rules and Regulations, the laws were introduced stage wise from the year
2007 onwards. They intended for the FSS Act to take care of international practices and
envisaged a policy framework designed to eliminate multi departmental control and guide and
regulate persons engaged in manufacture, marketing, processing, handling, transportation,
import and sale of food.
The Food Safety Regulation (EC) No. 178/2002 in United Kingdom ascribes a crucial role to
consumer protection, setting forth the principles of transparency, traceability, and
responsibility of business operators; establishing a rapid alert system and crisis management
plan; and, most importantly, establishing the European Food Safety Authority (EFSA). EFSA
provides scientific opinions and scientific and technical assistance, establishes surveillance
procedures, promotes cooperation among food safety organisations, and plays a crucial role in
risk assessment and communication.
The main regulation controlling all foods in Thailand is the Food Act B.E. 2522 (1979) under
the regulation of US FDA. It provides the government and officials with the authority to control
domestic production and imports and exports of food products for sale, as well as provide the
criteria and penalties for food business in Thailand
Keywords: Food safety, Food Law, FSS Act India, EFSA, risk management, HACCP, US
FDA
4
TABLE OF CONTENTS
1. INTRODUCTION
1.1 FOOD LAWS & REGULATIONS IN INDIA
1.1.1 Food authorities
1.1.2 Law Applicable to Manufacturers, Sellers and Consumers
1.1.2.1 Licensing and Registration
1.1.2.2 Product Approval
1.1.2.3 Food Standards and Ingredients
1.1.2.4 Labelling
1.1.3 Import Related Provisions
1.1.3.1 Licenses
1.1.3.2 Ingredients
1.1.3.3 Labelling Requirements
1.1.4 Foreign Direct Investment (FDI) Policy
1.2 FOOD LAWS & REGULATIONS IN UK
1.2.1 Emergence
1.2.2 General objectives
1.2.3 Risk analysis principle
1.2.4 Precautionary principle
1.2.5 Transparency
1.2.6 Tasks, Structure, and Operation
1.3 FOOD REGULATIONS IN THAILAND
1.3.1 Food Act of B.E. 2522 (1979)
1.3.2 Food Additives Regulations
1.3.3 Food Pathogens Control Measures in Food Products
1.3.4 Packaging and Container Regulations
1.3.5 Labelling Requirements
2. REVIEW OF PREVIOUS STUDY
3. RESULTS & DISCUSSIONS
4. CONCLUSION
5. REFERENCES & CITIATIONS
5
INTRODUCTION
Over the last decade, there have been significant changes in the national and international
regulatory frameworks governing food control, food safety and food trade. The adoption of the
Codex Alimentarius as the source of international food standards by the World Trade
Organization Agreement on Sanitary and Phytosanitary Measures (SPS Agreement) in 1995
has been one of the most significant recent influences on food regulation worldwide, and can
be seen as an acknowledgment of the increasing globalization of food production and food
trade. Worldwide outbreaks of food-borne disease, with concomitant media attention and
outspoken consumer concerns, have also triggered unprecedented interest in food control and
food regulation and in the country level infrastructures which govern food safety. Equally, the
last decade has seen heightened interest in the intersections between food safety and other areas
of agriculture which have heretofore been treated separately, such as plant quarantine and
animal quarantine. Often these topics are combined under the heading “biosecurity”, which is
generally understood to mean protection from the environmental, economic and human health
risks of potentially harmful plant and animal pests and diseases, alien invasive species and
genetically modified organisms. In a number of countries, governments have vested food
safety, animal quarantine and plant quarantine authority in a single executive agency which
carries out inspections “from farm to fork” and aims to protect animal, plant and human life
and health.
FOOD SAFETY REGULATIONS IN INDIA
India Food Safety Regulations India’s food laws have had a revamping from the last few years.
It has focused on –
➢ Prevention of food adulteration;
➢ Regulation for providing hygienic conditions of processing/ manufacturing;
➢ Protection of the domestic agriculture and livestock sector from pests and diseases;
➢ Inform consumers about the products they eat (such as vegetarian or non-vegetarian,
maximum price to pay, etc.); and
➢ Provision of product specifications.
Like all other countries, as a requirement of WTO all food safety laws are applicable to the
Indian manufactures as well as foreign manufacturers, (national treatment). The “Food Safety
6
and Standards Act, 2006,” was enacted by the Government of India (GOI), constituted a Food
Safety Standards Authority of India (FSSAI) with the objective of consolidating various food
laws and establishing a single regulatory agency.
The Food Safety Authority of India, (FSSAI) was created to:
➢ Lay down food standards
➢ Effectively regulate the manufacture, import, storage, distribution, and sale of food to
ensure consumer safety and promote global trade
➢ Pool infrastructure, manpower, testing facilities, and
➢ Rationalize and strengthen the existing enforcement mechanism. FSSAI is responsible
for fruits, meat, milk products, processed, and novel foods. The salient features of the
Indian food safety laws are as follows, (FAIRS GAIN Report, 2010)
➢ A single regulatory authority, namely Food Standards and Safety Authority (FSSAI) of
India was created to ensure uniform regulatory regime and standards for products.
➢ Food Safety and Standards Regulations, 2010, which has been notified to the WTO and
has now been published in the Official Gazette of India (21st October, 2010). This
repeals a number of individual Acts and orders pertaining to quality and packaging of
food products.
➢ Indian exporters and importers conducting business in India are required to hold valid
FSSAI licence though no such restrictions are placed on companies exporting food
products to India.
➢ The food business operators who can be food processor, manufacturer, exporter, or
importer, shall ensure that the food meets all the standards laid under the FSSAI’s Food
Safety and Standards Regulations, 2010;
➢ On 1st December, 2004, the Department of Health (DOH) issued a gazette notification
that lists permitted food additives in fish and fish products and microbiological
requirements of seafood
Under the new regulations:
➢ Importers must furnish an import declaration in the prescribed bill of entry format,
disclosing the value of the imported goods. This must be accompanied by any import
license and phytosanitary certificate (in case of agricultural commodities), along with
documentation such as sales invoices and freight and insurance certificates. All
7
consignments are required to be inspected prior to clearance. The FSSAI has also
authorized its officers at Mumbai, Nhava Sheva, Haldia, Kolkata, and Chennai sea ports
to oversee the clearance process of imported food products;
➢ Customs officers inspect incoming consignments, draw samples, and forward the
samples to FSSAI port officers, who verify that the imported food product complies
with the Indian food laws. The FSSAI port officers take the samples and, based on the
regulations, send the samples for required tests to FSSAI approved labs. The FSSAI
port officers will issue a "No Objection Certificate", if lab analysis results show that the
imported food product is in compliance with the Indian food laws. Customs officers
will refer to the "No Objection Certificate" issued by the FSSAI port officers after
which the consignment is released for distribution and sale in India. If the consignment
does not comply with the Indian food law, then the FSSAI port officers inform the
customs officers to detain, reexport, or destroy the consignment.
➢ FSSAI maintains the procedures for sampling, testing, and clearance of imported foods
and all the rules and procedures as they were under the PFA Act, as amended). The
procedures for sampling and lab analysis are described in Chapter IX of Food Safety
and Standards Regulations, 2010.
Food Authorities
At the Central (federal) level, the Food Authority is comprised of senior government officials,
including those from the Departments of Agriculture, Food Processing, Health, Consumer
Affairs, and Commerce. The Food Authority is also comprised of representatives of the food
industry, consumer organisations,
food technologists/scientists, farmer organisations, and retailer organisations. The Food
Authority is supported by a Central Advisory Committee, various panels and a Scientific
Committee. The day to day activities of the Food Authority are carried out by a CEO and other
officers and employees. In addition to the authorities at the Federal level, each State has a
Commissioner of Food Safety/Health and Family Welfare and multiple officers known as
“Designated Officers” who, inter alia, are responsible for processing applications for and
issuing licenses. Each State also employs “Food Safety Officers” who oversee the active
sampling and seizure procedure, and forward the same to Food Analysts, also
8
appointed under the terms of the FSS Act. The Food Analysts use recognised and accredited
food laboratories for discharge of their duties.
Law Applicable to Manufacturers, Sellers and Consumers
• Licensing and Registration
Registration is required for Petty Food Business Operators, a category constituted, inter alia,
of food stall operators (even stalls of a temporary nature), itinerant vendors, those working
from home-based kitchens, road-side tea vendors, etc. The implementation of the registration
requirement for Petty Food Business Operators is an enormous practical challenge. Authorities
are attempting to regulate those who do not even have a temporary place of business but who
may move around on bicycles vending milk, or with their daily output of food produced in their
home kitchens and moving on foot. A vast majority of these vendors are illiterate, unaware of
the requirements of law, and have no access to newspapers or
other media where the Food Authority regularly advertises various facets of law for the
awareness of the public at large. Interestingly, the Licensing Regulations also seek to bring
within its purview arrangements made for religious gatherings. It is not unusual in India to
celebrate religious, or even personal, occasions by distributing food and/or beverages to the
less privileged. Nothing in the Licensing Regulations suggests that the registration requirement
is limited to places of worship which distribute food to the needy on a daily basis. While the
effort to implement the registration, requirement is laudable from the point of view of
controlling sanitary and hygiene conditions, even in the case of free distribution of food to the
poor, it remains to be seen if such a requirement can be strictly implemented by its officials
against individuals setting out to feed the poor. Separate from the registration process is the
license process which is applicable to those who are not Petty Business Operators (with
reference to the scale of operations). While a license for a food business is primarily obtained
at the State/local level where the business is operational, for specified businesses the license is
granted by at the Federal level—including for importers and food business operators operating
in two or more States.
Food business operators who manufacture any article of food containing ingredients or
substances or using technologies or processes, or a combination thereof, whose safety has not
been established through FSS Act and related regulations, or which do not have a history of
safe use, or food containing ingredients being introduced for the first time into the country need
9
to apply for product approval separately before applying for license. The Food Authority has
clarified the circumstances when a single or multiple licenses would be required for the same
premises. If the products being handled at a single premise can be treated as connected then
only one license will be required. According to the Food Authority, if processing of meat, milk,
fruits and vegetables is being undertaken in the same premises, separate licenses must be
obtained as each activity will be done in separate portions and the businesses are not connected.
However, where the premises have facilities for fruit and vegetable processing as well as a
store along with it, since these are connected activities, only one license would be required.
Indian food laws do not specify requirements for separate facilities for nuts and/or soy or other
ingredients which are known internationally to cause allergies, or labelling requirement
concerning traces of such ingredients—this may be due to a general perception that such
allergies are uncommon in the Indian population and/or the fact that there may be inadequate
data concerning the existence of such allergies in the Indian population.
• Product Approval
Foods for which standards are not prescribed under the FSS Act and related regulations or
which contain ingredients or substances whose safety has not been established, or which do not
have a history of use in India, need to apply for product approval separately before, applying
for license. The product approval requirements are either relatively relaxed or more arduous
depending on the category into which the food products fit. For instance, if the products do not
contain plants or botanicals or animal origin substances and the safety of the ingredients are
known and permitted under the applicable FSS regulations/Codex and other regulatory bodies
like the EU/USFDA/FSANZ the products would be granted approval as a matter of formality
with relative ease. However, if the products contain plants or botanicals or animal origin
substances irrespective of the safety of the ingredients being known and permitted under the
applicable FSS regulations/Codex and other regulatory bodies like the EU/USFDA/FSANZ,
the application form for such products is not only more detailed requiring exhaustive
information and documents, the timelines typically are extended before the approval or No
Objection Certificate (NOC) is granted. The NOC serves as an interim permission to place the
food in the market for a year during which time the product is assessed by the Scientific Panel
for safety. If the safety assessment is prolonged beyond a year, the NOC is extended. There is
a separate identified category of foods referred to as “traditional/ethnic” food which is treated
in a more relaxed fashion and is exempt from the requirement of product approval—these foods
10
range from traditional savouries such as spice fried dals (lentils/pulses) to indigenous sweets
such as gulab jamuns. While the FSS Act is intended to take care of international practices and
the Food Authority, when dealing with product approval, refers to acceptability under
international regulatory bodies such as EU/USFDA/FSANZ, there are certain challenges in
maintaining complete uniformity for well-established international products. For example, if
nutritional supplements are to be introduced into India, their acceptability in other regions for
years does not necessarily mean an automatic acknowledgment of safety and hence approval.
This is especially so in the case of added minerals and vitamins where the ICMR guidelines
stipulating Recommended Dietary Allowance (Indian RDA) are the sole acceptable standard
in India, and any deviations from the Indian RDA are liable to be rejected. No doubt, the Indian
RDA being based on Indian population should take precedence over any other country’s RDA.
However, even when one accepts the supremacy of the Indian RDA for the Indian population,
there are certain challenges in such universal implementation which may have been unforeseen
by the Food Authority.
The Food Authority does not clarify the treatment of products aimed at those who are outside
the mean population that the Indian RDA is based on. Any nutritional supplement for, say, the
elderly (whose nutritional requirement may merit additional vitamins or minerals) will fall
afoul of the Indian RDA (which are calculated on the basis of “men between 18–29 years of
age and weighing 60 kg with a height of 1.73 m with a BMI of 20.3 and who are free from any
disease and physically fit for active work”). There is no denying that with increases in age the
requirement for minerals and nutrients in the body change due to various factors such as loss
of appetite, difficulty in absorption due to medicine intakes, etc., and as
a result there may be a requirement for increased nutrient intake. Some examples of the
differences between the Indian RDA and the international RDA requirements follow:
• For Vitamin C the Indian RDA limit is 40 mg, while the limit prescribed in the
European Union Directive 90/496/EEC on nutrition labelling for foodstuffs as regards
recommended daily allowances, energy conversion factors, and definitions is 80 mg;
• For Vitamin B12 the Indian RDA limit is 1 μg, while the limit prescribed in the
European Union Directive 90/496/EEC on nutrition labelling for foodstuffs as regards
recommended daily allowances, energy conversion factors and definitions is 2.5 μg;
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• For Selenium the Indian RDA limit is 50 μg, while the limit prescribed in the European
Union Directive 90/496/EEC on nutrition labelling for foodstuffs as regards
recommended daily allowances, energy conversion factors, and definitions is 55 μg.
It may be more appropriate for the Food Authority to summarily reject products containing
vitamins and minerals beyond the Indian RDA limits ordinarily but make allowance for
variation on account of the target consumer. The reference to international guidelines would
have then perhaps be appropriate, relevant, and real, taking into account products aimed at a
specialised population in countries where the safe consumption of the products has been
established.
• Food Standards and Ingredients
Standards including permitted ingredients and quantities for ingredients are prescribed for
about 13 broad categories of foods (e.g.: dairy products, fats and oils, fruit and vegetable
products, cereals and cereal products, meat and meat products, fish and fish products, spices
and condiments, sweets and confectionary, sweetening agents, beverages, etc.). Each category
comprehensively covers specific food items totalling about 150 identified food and beverage
items ranging from globally identifiable items such as different types of cheese, chewing gums,
and chocolates to more locally relevant products, such as ghee (in the milk products category)
and jaggery (categorized under sweets and confectionary). Additionally, standards are
prescribed for food additives such as permitted colours, artificial sweeteners, preservatives,
anti-oxidants, emulsifying agents and anticaking agents. For example, only lecithin, ascorbic
acid, and tocopherols are generally permitted for use as anti-oxidants. Further, colouring agents
are classified into the following sub-categories:
(i) Natural Colouring Matters such as beta carotene, chlorophyll, saffron, curcumin,
caramel etc. are generally permitted to be used;
(ii) Inorganic Colouring Matters and pigments are generally not permitted for use
unless otherwise provided in for the Food Additive Regulations; and
(iii) Synthetic Food Colours such as ponceau, carnosine etc. are permitted to be used
only in specified food products.
Further, the Food Standard Regulations classifies ‘Preservatives’ into two classes as follows:
12
(i) Class I preservatives such as common salt, sugar, spices, vinegar, honey and edible
vegetable oils, etc., which can generally be used; and
(ii) Class II preservatives which are restricted for use in specified foods to specified
limits. There is also a restriction on using more than one Class II preservative even
in the foods where individual Class II preservatives are permitted.
The Flavouring Agents and Related Substances are permitted to be used subject to appropriate
labelling and are classified as follows:
(i) Natural Flavours and Natural Flavouring substances;
(ii) Nature-Identical Flavouring Substances; and
(iii) Artificial Flavouring Substances—covering those substances which have not been
identified in natural products intended for human consumption, either processed or
not.
At the opposite end of the requirements of specific standards is the category of Proprietary and
Novel Foods. This category covers all food for which standards have not specifically been
prescribed. However, regulatory restrictions concerning permissible ingredients and limits on
the use of certain other ingredients all apply to Proprietary Foods. The Food Standard
Regulations also identify the foods which can undergo irradiation, the minimum and maximum
doses of irradiation, and the facilities at which foods can undergo irradiation.
• Labelling
The food laws related to labelling are primarily contained in the Packaging and Labelling
Regulations which are read along with the LMPC Rules. The LMPC Rules provide for the
manner of packaging of commodities and the declarations to be made on packed commodities.
The LMPC Rules expressly provide that no person shall pre-pack, or cause or permit to be pre-
packed, any commodity for sale, distribution, or delivery unless the label is securely affixed
and the requisite declarations have been made on the package in which the commodity is pre-
packed.
The Packaging and Labelling Regulations stipulate certain mandatory information,
declarations, and specifications to be provided on the labels of every pre-packaged food
proposed to be imported, stored, and/or sold in India. As per LPMC Rules, separate labelling
requirement apply to wholesale packages which consist of multiple packages which can then
13
be retailed individually. Since the labelling requirement for retail packages are extensive, the
declarations for wholesale packages are more relaxed, requiring only the name and the address
of the manufacturer, importer (and in some instances the packer), the identity of the commodity
contained, and the total number or weight of the retail package (s) contained in the wholesale
package.
➢ “Vegetarian” or “Non-Vegetarian” Food Labelling
This requirement reflects the vast population of Indians who are vegetarian for religious
reasons. It is not only the use of meat products per se that require a food to be labelled “non-
vegetarian”, but even ingredients such as gelatine (which traditionally has been sourced from
animal products) would lead to a food item being labelled nonvegetarian”. Gelatine itself is a
standardised ingredient: i.e. standards are prescribed for it and special labelling requirement
(other than “non-vegetarian”) applies to the use of gelatine. The declaration to the effect that a
food is non-vegetarian or vegetarian is made by a symbol with the former being identified by
a brown colour filled circle inside a square with brown outline and the latter by similar symbol
in green colour. From a consumer information standpoint, both the Packaging and Labelling
Regulations as well as the LMPC Rules specify details such as, inter alia, the quantity
declaration being free from printed information on all its sides by specified space, the heights
of numerals made in the declarations, and the label’s proportion. in comparison to the principal
display panel (with the principal display panel being pretty much the entire package/container
of food). There are further requirements concerning the non-vegetarian or vegetarian symbols,
including the diameter of the sides of the square and size of the symbol in comparison to the
principal display panel, and for the symbol to be prominently displayed on the labels having a
contrasting background on the principal display panel, and being placed in close proximity to
the name or brand name of the products.
➢ Other Information, Declarations and Specifications Required to be Stated
In addition to the non-vegetarian or vegetarian declaration, some more India specific labelling
requirements include:
(i) the labelling language must be either English or Hindi
(ii) the format for declaration of maximum price at which the product may be sold to
the end consumer viz. ‘MRP Rs. . .. . .incl. of all taxes’ or Maximum or Max. retail
price. . .. . . inclusive of all taxes’ or in the form.
14
The Packaging and Labelling Regulations mandate the use of the International System of units
in declaring the net quantity of the commodity on the labels including kilogram and grams.
Other information, declarations and specifications required to be stated on the labels of foods
include:
➢ Name/description of the Food Product.
List of Ingredients—in the mode and manner prescribed including, but not limited to: listing
the name of the ingredients in descending order of their composition by weight or volume, as
the case may be; declaration of constituents of compound ingredients, etc.
Nutritional Information per 100 g or per serving of the product with specifics of kcal, protein,
carbohydrates from sugar, and fat.
In cases where a nutrition or health claim is made, depending on the kind of claim, a declaration
may need to be made concerning the amount of fatty “Non-Vegetarian Declaration” (brown)
“Vegetarian Declaration” (green) acids, monounsaturated fatty acids, and polyunsaturated
fatty acids and/or cholesterol and/or trans fatty acids.
Further standards are specified as to the amount of trans fats or saturated fats that may be
present in a product for a health claim of ‘trans-fat free’ or ‘saturated fat free’.
➢ Declaration Regarding Food Additives—under the following class titles together
with the specific names or recognised International Numerical Standards (INS):
Acidity Regulator, Acids, Anticaking Agent, Antifoaming Agents, Antioxidant, Bulking
Agent, Colour, Colour retention Agent, Emulsifier, Emulsifying Salt, Firming Agent, Flour
Treatment Agent, Flavour Enhancer, Foaming Agent, Gelling Agent, Glazing Agent,
Humectant, Preservative, Propellant, Raising Agent, Stabilizer, Sweetener, Thickener.
There are specific recommended declarations for the extraneous addition of colouring matters
related to the sub-category of the colouring matter used. If the statement is displayed along
with the name or INS number of the food colour, the colour used need not be declared in the
list of ingredients. Similarly, there are specific recommended declarations for the extraneous
addition of flavouring agents and also separately for cases where both colour and flavour are
used.
15
Instructions for use including for reconstitution, if necessary, to ensure correct utilization of
the product.
➢ Name and Complete Address of the Manufacturer and Packer. If the address of the
manufacturer and the manufacturing unit are different, both have to be specified. The
name and address of the packer is required when the manufacturer is not the packer.
In cases of contract manufacturing for some other manufacturer or company under the latter’s
brand name, the label will need to state the name and complete address of the manufacturing
or packing unit, as the case may be, and also the name and complete address of the brand name
owner for, and on whose behalf, the product is manufactured or packed.
➢ Contact Details of the person who can be contacted in case of consumer complaints.
➢ Lot/Code/Batch Identification, enabling tracking in manufacture and identification
after distribution: The date, month and year of manufacture, packing or pre-packing of
the product.
➢ Best Before and Use By Date in any one of the three specified formats.
➢ The net weight or number or measure of volume of contents which would need to
exclude the weight of wrappers and materials of the package.
➢ Additional and specified declarations need to be made for certain foods such as for
infant foods, irradiated foods, artificial sweeteners, food colours, edible oils, drinking
water, foods containing monosodium glutamate, etc.
The LMPC Rules and the Packaging and Labelling Regulations mandate clear and
unambiguous declarations including specifying instances where declarations must be printed
in a colour which contrasts the background. The LMPC Rules and the Packaging and Labelling
Regulations prescribe any description or presentation or labelling that is false, misleading or
deceptive or is likely to create an erroneous impression regarding the product’s character in
any respect. The aforesaid rules and regulations stipulate against use of words such as
“recommended by the medical profession” or any words which imply or suggest such
recommendation. They direct against declarations of quantity with words, or expressions which
may lead to exaggerated, misleading or inadequate impressions, such as the use of the
following words or phrases: ‘minimum’, ‘not less than’, ‘average’, ‘about’, ‘approximately’,
etc. The required declarations need to be printed on each label, as LMPC Rules do not permit
affixation of individual stickers on the package for altering or making declarations. The only
16
exception is that a sticker may be used for reducing the retail sale price of a commodity, as
long as such a sticker does not cover the original retail sale price stated on the package.
➢ Exemptions from Labelling Requirements: By Legal Provisions and by Practice
Packaging and Labelling Regulations prescribe, inter alia, limited and specific exemptions
from labelling requirements for packaged products if the surface area of the package is not
more than 100 square centimetres. There is additional relaxation for packages whose surface
area is less than 30 square centimetres. Certain exemptions also apply to a package which
qualifies as a ‘multi piece package’, i.e., it is a package containing two or more individually
packaged or labelled pieces of the same commodity of identical quantity, intended for retail
either in individual pieces or as a whole. While the aforesaid labelling exemptions are provided
in law, certain labelling requirements are routinely not enforced in practice, leading to a
perception that exemptions have been extended by the authorities. The risk of relying on such
practice is that at any point in time, the Food Authority, and hence other government
departments, may decide otherwise. This sudden decision could be the result of
economic/foreign policies which cannot be foreseen.
For example, the requirement to label beverages, especially imported alcoholic beverages had
not been enforced by the Food Authority for some time. However, as per recent reports there
are containers of imported Scotch whisky and wines pending clearance at customs since the
Food Authority had taken a decision to enforce labelling provisions for such beverages. While
European manufacturers and exporters have reportedly dug in their heels concerning labelling,
the recent stringent application may also be a direct response to the EU banning import into
Europe of Indian mangoes and other produce products.
The Indian authorities’ stance, that it does not matter what the US and EU prescribe since
Indian laws provide otherwise, while technically sound, does seem contrary to one of the
objects and reasons for the new Indian food laws— moving towards international practices. If
world over the consumer can be expected to know what Scotch whisky and wine are comprised
of, or at least not be the worse for wear without that knowledge, then the Indian labelling
requirements being made applicable to imported wines and whiskeys seems excessive.
➢ Trademarks Protection
17
Products of various food brands from across the world have become a common sight in the
marketplaces and dining rooms in India. The effective branding strategies for these products
are essential ensuring their distinctiveness and making them easily recognisable to consumers
and to help in achieving and sustaining a competitive market share. Given the appeal of these
global/Indian brands in the food sector, trademark protection has become a growing priority
for the major players in the food sector.
Trademarks can include words, logos, shapes (of the food product itself or its packaging),
slogans, specific colours and sounds. Some of the more well know food brands in India include
McDonalds, Coca Cola, Maggi, Dominos, Cadbury, and many others. In terms of the Trade
Marks Act, 1999, proprietors of these brands are afforded adequate protection against the
infringement of the rights in their respective brands. Below are some recent examples of
protection by the courts in India, of some well-known food brands:
1. Cadbury Ltd vs. Tims Foods Private Ltd
This suit was filed by Cadbury against Tims Food, seeking permanent injunction against Tims
Food from infringing Cadbury Dairy Milk ‘eclairs’ labels/ wrappers. The Court ruled that the
trade dress/wrapper adopted by Tims Foods was deceptively similar to that of Cadbury and
concluded that there had been undue enrichment to Tims Foods to the detriment of Cadbury.
Injunction was granted to Cadbury and it was awarded damages amounting to ₹ 500,000/-.
2. The Coca-Cola Company vs. K.M. Salim
The High Court of Delhi held, that when a trademark is identical to a registered trademark and
goods/services for which it is used are also identical to goods or services for which registration
has been granted, then the Court shall presume that it is likely to cause confusion on part of
public and therefore granted injunction to the Coca-Cola Company.
3. Heinz Italia vs. Dabur India Ltd.
Injunction was granted against marketing of a product under the brand ‘Glucose-D’, as the
brand was deceptively similar to ‘Glucon-D’, a registered trade mark of Heinz Italia.
Import Related Provisions
18
Pursuant to obtaining an Import–export Code (IEC) under the Export–import Policy of India
from the office of the Director General of Foreign Trade, importers may import food for which
there are few additional requirements as well as some relaxation of existing requirements.
• Licenses
As discussed above, all importers would require a license from the Food Authority at the
Federal level.
• Ingredients
The provisions of the FSS Act apply in totality with reference to the use of ingredients, and
restrictions for all imported food items.
• Labelling Requirements
A food item’s country of origin needs to be stated on the labels of imported foods. If a food
product has undergone processing in a second country which changes the nature of the food
product, then the country in which the processing is performed is considered to be the country
of origin for the purposes of labelling. In the case of imported foods, the name and address of
the importer in India is also required.
Foreign Direct Investment Policy as Applicable to the Food Industry
The Government of India in general permits investments in the food processing sector under
the “automatic route”, i.e., without the requirement for further approvals for investment.
However, there are certain categories of food products which are reserved for the micro and
small-scale sector where foreign direct investment is eligible for the automatic route only for
up to twenty-four per cent (24 %) foreign direct investment.
19
FOOD REGULATIONS IN UK
Food scarce of the 1990s, the Bovine Spongiform Encephalopathy (BSE) and the dioxin
contamination in Belgium made the European Commission (EC) to reanalyse its food safety
regulations. In 1997, the EC issued a green paper concluding that the earlier food legislations
fell short of meeting the needs of the consumers, producers, and manufactures of food products.
In 2000, recognizing the need for measures to deal with food, the Commission decided that an
independent European Food Safety Authority (EFSA) would be a best way to ensure food
safety (White Paper on Food Safety, 2000). It was decided to introduce the concept of scientific
risk-based assessment for decisions on regulations. Till then, the EU policy intent was to
eliminate trade barriers within the community and its goal was free flow of products (economic
gains) rather than safety assurance.
In 2002, the Council of the EU and the European Parliament adopted Regulation (EC) No.
178/2002, presenting the principles of General Food Law and creating the European Food
Safety Authority (EFSA). This made the decisions centrally controlled. EFSA is an
independent agency that provides scientific advice to member states and EU institutions. It
gathers data to help anticipate risks and issues opinions on matters relating to human nutrition
and health, animal welfare, plant health, and genetically modified organisms. It gives scientific
evaluation to food safety issues. The EFSA gives scientific risk assessments but does not handle
any of the risk management. Instead, the European institutions and the member states
themselves are responsible for risk management.
European Food Safety Authority (EFSA). EFSA provides scientific opinions and scientific and
technical assistance, establishes surveillance procedures, promotes cooperation among food
safety organisations, and plays a crucial role in risk assessment and communication. EFSA’s
first 10 years of activity has achieved a positive balance: despite the dramatic changes within
the EU, it has successfully adapted itself. The need for the harmonisation of food hygiene
requirements led to the adoption of the hygiene package and the HACCP system (Reg.
852/2004), as well as of specific hygiene rules applicable to products of animal origin (Reg.
853/2004). The conclusions drawn are encouraging: EU food law, by adopting harmonised
vertical rules and regulations common to all operators, has committed to ensuring common,
high quality standards. EU authorities’ capacity to promptly and effectively react to significant
food crises has led to one of the most developed systems worldwide, one that is functional for
20
operators and safe for consumers. Yet the need for rapid, repeated actions, is a constant
challenge, which certainly cannot be considered complete.
The general principles of food and feed law are outlined in the General Food
Law Regulation (Articles 5 to 10). They form a horizontal framework underpinning all Union
and national measures relating to food and feed. They cover all stages of the production,
processing and distribution of food as well as feed produced for (or fed to) food-producing
animals.
General objectives of food and feed law:
➢ Guarantee a high level of protection of human life and health and the protection of
consumers’ interests. Also guarantee fair practices in food trade, taking into account
animal health and welfare, plant health and the environment
➢ Ensure free movement of food and feed manufactured and marketed in the Union, in
accordance with the General Food Law Regulation
➢ Facilitate global trade of safe feed and safe, wholesome food by taking into account
international standards and agreements when developing Union legislation, except
where this might undermine the high level of consumer protection pursued by the
Union.
Risk analysis principle
The General Food Law Regulation establishes the principle of risk analysis in relation to food
and feed and establishes the structures and mechanisms for the scientific and technical
evaluations, which are undertaken by the European Food Safety Authority (EFSA).
Depending on the nature of the measure to be used, food law, and in particular measures
relating to food safety must be underpinned by strong science. The Union has been at the
forefront of the development of risk analysis principles and their subsequent international
acceptance. Food law is based on the three inter-related components of risk analysis:
• risk assessment
• risk management
21
• risk communication.
Risk assessment must be undertaken in an independent, objective and transparent manner
based on the best available science.
Risk management is the process of weighing policy alternatives in the light of results of a risk
assessment and, if required, selecting the appropriate actions necessary to prevent, reduce or
eliminate the risk. In the risk management phase, the decision makers need to consider a range
of other information in addition to the scientific risk assessment. These include, for example:
• most effective risk reduction actions
depending on the part of the food
supply chain where the problem
occurs
• feasibility of controlling a risk
• socio-economic effects
• environmental impact
• a wide range of other factors
legitimate to the matter under
consideration
Risk communication is the interactive exchange of information and opinion throughout the
risk analysis process among risk assessors, risk managers, consumers, feed and food
businesses, academics, other interested parties.
Precautionary principle
The precautionary principle (Article 7 of the General Food Law) refers to specific situations
where:
• there are reasonable grounds for concern that an unacceptable level of risk to health exists
• the available supporting information and data are not sufficiently complete to enable a
comprehensive risk assessment to be made.
When faced with these specific circumstances, decision makers or risk managers may take
measures or other actions based on the precautionary principle, while seeking more complete
scientific and other data. Such measures have to comply with the principles of non-
discrimination and proportionality and should be provisional until the time when more
comprehensive information concerning the risk can be gathered and analysed.
Transparency
22
Food safety and protection of consumer interests are of great concern to the general public,
non-governmental organisations, professional associations, international trading partners and
trade organisations. Therefore, transparency of decision-making is of paramount
importance. The General Food Law Regulation provides for the mechanisms necessary to
increase consumer confidence in food law:
• Effective public consultations during the preparation, evaluation and revision of food and
feed law
• Obligation on public authorities to inform the general public, where there are reasonable
grounds to suspect that a food or feed may present a risk for human or animal health.
Tasks, Structure, and Operation
EFSA’s main task is to ensure constant, competent, and independent technical advice and
scientific support in the matter of food safety by collecting and analysing data either collected
by it or brought to its attention. As specified in the Regulation “The Authority should be an
independent scientific source of advice, information and risk communication in order to
improve consumer confidence”. In performing its duties, the Authority must also: offer
scientific advice, together with scientific and technical support on human nutrition; formulate
scientific opinions on any issue related to the health and welfare of animals, and to the health
of vegetables; and formulate scientific opinions on non-food and non-feed products that may
be traced back to genetically modified organisms. Therefore, it is a fundamental reference for
the new system, capable of supporting the preparation, definition, and implementation of food
legislation, also through a coordination of roles among the competent bodies of the different
Member States and the Community bodies.
Article 23 of Regulation No. 178/2002 clarifies and lists the tasks of the Authority, by
establishing that the latter must:
(a) provide scientific and technical assistance and advice;
(b) provide opinions on the subject matter;
(c) search for, collect, collate, analyse, and summarise scientific and technical
data in the fields within its mission;
(d) contribute to collaboration amongst the different organisations operating
in the fields within its mission and create a European network; and
(e) identify and communicate emerging risks.
23
FOOD REGULATIONS IN THAILAND
The laws and regulations governing the Thai food industry are confined to the scope of the
Food Act B.E. 2522 (1979). The Food Act authorizes the Ministry of Public Health’s Food and
Drug Administration (FDA) to implement and administer the Food Act.
Under the Act, all establishments producing food for sale or importing food for sale must be
licensed by the Food Bureau of the FDA. The application and granting of licenses must be in
accordance with the principles, procedures or conditions prescribed in the Ministerial
regulations, which are periodically elaborated, modified, and issued by the FDA’s Food
Bureau.
Food Act of B.E. 2522 (1979)
The Food Act of B.E. 2522 (1979) remains in effect. The Act defines the word “food” as edible
items and those which sustain life including:
(A) Substances that can be eaten, drunk, dissolved in the mouth or induced into the body by
mouth, no matter in what form, but not including medicine, psychotropic and narcotic
substances.
(B) Substances intended for use or to be used as ingredients in the production of food including
food additives, coloring, and flavoring materials.
The Food Act classifies food into four categories as listed below:
1. Specifically-controlled foods: Under this category, product registration is required.
Legal provisions are established regarding standard quality, specifications, packaging
and labeling requirements, as well as other aspects of good manufacturing practices.
2. Standardized foods: Foods produced under this category must adhere to quality
standards as defined in the regulations. This category was created to standardize the
production of locally produced food from small-scale or household industries in order
to provide consumers the ability to differentiate such products by qualitative attributes
and to encourage food producers on attaining hygienic quality of their products.
3. Foods required to bear standardized labels: This category is less-restrictive than the
first two categories, as foods under this category pose a lower risk to consumers’
24
health and does not have to follow specific quality standards for manufacturing.
However, products must bear standardized labels that provide consumer information.
4. General foods: Consists of raw, cooked, preserved, non-preserved, processed or non-
processed foods that are not listed in the above categories. Although registrations are
not required, general food products are controlled and monitored based on hygiene,
safety, labelling and advertisements.
The following food production categories are also subject to additional regulations. These
include: quality standards for food containers, plastic containers, and feeding bottles.
Prohibited Food and Substances
1. Substances prohibited in foods:
• Calcium iodate or potassium iodate except to be used to adjust the nutrition that
relates to iodine deficiency as approved by the Thai Food and Drug Administration.
• Nitrofurazone
• Formaldehyde, formaldehyde solution and paraformaldehyde
• Methyl alcohol or methanol except for use as processing aids for export purpose.
2. Foods prohibited to be manufactured, imported, or sold:
(i) Brominated vegetable oil
(ii) Salicylic acid
(iii) Boric acid
(iv) Borax
(v) Potassium chlorate
(vi) Coumarin, or 1,2-
benzopyrone, or 5,6-benzo-
alpha-pyrone, or cis-o-
coumaric acid anhydride, or
o-hydroxycinnamic acid,
lactone
(vii) Dihydrocoumarin, or
benzodihydropyrone, or 3,4-
dihydrocoumarin, or
hydrocoumarin
(viii) Diethylene glycol, or
dihydroxydiethyl ether, or
diglycol, or 2,2’-oxybis-
25
ethanol, or 2,2’-
oxydiethanol
(ix) Dulcin or 4-
ethoxyphenylurea or para-
phenetolcarbamide
(x) AF-2 or 2-(2-furyl)-3-(5-
nitro-2-furyl) acrylamide or
furylfuramide
(xi) Potassium bromate
(xii) Formaldehyde,
formaldehyde solution and
paraformaldehyde
(xiii) Melamine and its analogues,
specifically cyanuric acid
(xiv) Foods in which substance
no. 1-13 is used as
ingredient.
(xv) Genetically modified foods
containing Cry9C DNA
Sequence and foods
containing such genetically
modified food.
(xvi) Ready-to-eat gelatin and
jelly, containing
glucomannan or konjac
flour packed in small
containers with a diameter
or diagonal width no larger
than 4.5 cm.
(xvii) All kinds of puffer fish and
foods containing puffer fish
meat as an ingredient.
(xviii) Food containing objects
other than food packed
inside food packages, except
for the purposes of food
quality or standard
preservation such as
desiccator, oxygen absorber,
etc., and in separate
packages, seasonings or
consuming accessories
(such as plastic spoons,
chopsticks, measuring
spoons, etc.) Objects other
than food may be packed
with food packages, but
only if they do not pose a
risk to humans or mislead
consumers that those objects
can be eaten.
(xix) Partially hydrogenated oils
and foods contain partially
hydrogenated oils
3. Food prohibited to be imported or sold:
26
Foods with expiration dates or suitable periods of consumption, which have lapsed as stated in
the label:
• Infant food and food of continuous formula for infants and children.
• Supplementary food for infants and children.
• Modified food for infants and modified milk of follow-up formula for infants and
children
• Cultured milk
• Cow’s milk that has been pasteurized, for example, pasteurized fresh milk, recombined
pasteurized milk, flavored pasteurized milk and pasteurized milk products, etc.
• Food with special objectives.
Regulatory Procedures
While some of the following information does not specifically apply to U.S. exporters, the
following will be levied upon importers of U.S. products. The principles of regulatory
procedures for food involve the following aspects.
• Pre-marketing Control
Activities at this stage are the responsibility of the Food Bureau in the Thai FDA.
a) Establishing food standards and manufacturing requirements: Food manufacturing
standards and practices must meet the minimum acceptable requirements as
established by the Subcommittee on Food Standards and Local Manufacturing
Requirements.
b) Issuance of Food manufacturing licensing.
c) Issuance of Food Import license.
d) Food product registration.
e) Food labeling: Imported food products, which are categorized as specifically-
controlled foods, standardized foods, and foods that are required to display labels
27
according to the specific requisites of each category. Details on the labeling
requirements are provided in Section 2.
f) Nutrition labeling: Nutrition labeling is required for some products.
g) Good Manufacturing Practices (GMP)
h) Under Ministerial Notification No. 193, B.E. 2543 (2000), Method of Food
Manufacturing and Equipment for Manufacturing Food and Food Storage,
Thailand requires domestic manufacturers and foreign suppliers for 61 types of
products must adhere to GMP. These include:
• Infant food and follow-up
formula food for infants and
children
• Supplementary food for
infants and children
• Modified milk for infants
and follow-up formula
modified milk for infants
and children
• Ice
• Drinking water in sealed
containers
• Beverages in sealed
containers
• Food in sealed containers
• Cow’s milk
• Cultured milk
• Ice cream
• Flavored milk
• Other milk products
• Food additives
• Food colors
• Food enhancers
• Sodium cyclamate and food
containing sodium
cyclamate
• Food for weight control
• Tea
• Coffee
• Fish sauce
• Remaining solution from
Mono Sodium Glutamate
production
• Natural mineral water
28
• Vinegar
• Fat and oil
• Peanut oil
• Cream
• Butter oil
• Butter
• Cheese
• Ghee
• Margarine
• Semi-processed food
• Some particular kinds of
sauces
• Palm oil
• Coconut oil
• Electrolyte drinks
• Soybean milk in sealed
containers (except
manufacturers which are not
recognized as having a
factory conforming to the
Factory Laws)
• Chocolate
• Jam, jelly, marmalade in
sealed containers
• Food for special purposes
• Alkaline-preserved eggs
• Royal jelly and royal jelly
products
• Products from the hydrolysis
or fermentation of soybean
protein
• Honey (except
manufacturers which are not
recognized as having a
factory conforming to the
Factory Laws)
• Fortified rice with vitamins
• Husked rice flour
• Brine for cooking
• Sauce in sealed containers
• Bread
• Gum and candy
• Processed gelatin and jelly
desserts
• Foods packed together with
material intended for quality
control purposes
• Garlic products
• Some meat products
29
• Flavoring agents
• Foods containing aloe vera
• Frozen foods
• A prepared set of ready to
cook food, which separated
ingredients
• Bakery products
• Meat products as per the
Ministry of Public Health
no. 243 Re: Meat products
• Noodle made from rice flour
Food Additives Regulations
Food additives are substances which normally are not used as food or essential ingredients of
food, whether or not such substances have food value, but which are added for the benefits of
production technology, packing, storage or improve the quality or standards or the nature of
food. They also include substances mixed with food for the purposes stated earlier.
Food additives are specified as specifically-controlled food of which the quality or standards
are defined. Use of food additives must follow the set objectives for the specified kinds of food
and maximum permissible quantity, food additive functional classes categorized according to
CODEX as listed below:
• Acid
• Acidity regulator
• Anticaking agent
• Antifoaming agent
• Antioxidant
• Bulking agent
• Color
• Color retention agent
• Emulsifier
• Emulsifying salt
• Firming agent
• Flavor enhancer
• Flour treatment agent
• Foaming agent
• Gelling agent
• Glazing agent
• Humectant
• Preservative
• Propellant
• Raising agent
• Stabilizer
• Sweetener
• Thickener
30
Use of food additives for purposes other than stated must be petitioned for the FDA’s approval.
Any food additives not listed below, but are available under CODEX (GSFA) are generally
acceptable by the Thai FDA.
Pesticides and Other Contaminants
Food containing pesticide residues and contaminants are enforced by the Ministry of Public
Health’s Food and Drug Administration (FDA). Thai FDA establishes regulations and imposes
maximum residue limits (MRLs) based on the MRL standards established by the National
Bureau of Agricultural Commodity & Food Standards (NBACFS). In addition, the Department
of Agriculture (DOA) in the Ministry of Agriculture and Cooperatives (MOAC) controls the
use of agricultural chemicals.
Food Containing Pesticide Residues
The tolerance levels for residues allowed in foodstuffs are defined as Extraneous Residue
Limits (ERL) and Maximum Residue Limits (MRL). However, a zero tolerance level is set for
toxic substances in agriculture which are officially prohibited under the Notification of
Ministry of Agriculture and Cooperatives, except for the established Extraneous Maximum
Residue Limit.
• Food Containing Contaminants
According to Ministerial Notification No. 98 of B.E. 2529 (1986) and Ministerial Notification
No. 273 of B.E. 2546 (2003), food shall not contain contaminants with more than the following
specifications.
31
The Thai FDA requires that all food products must be free of the following chemicals and their
metabolites as stipulated in Ministry of Public Health’s Notification No. 299 B.E. 2549 (2006)
Re: Prescribed Standards for Some Chemical Contaminations in Foods (2nd Edition). A list of
chemicals under this regulation include the following:
• Chloramphenicol and its salts
• Nitrofurazone and its salts
• Nitrofurantoin and its salts
• Furazolidone and its salts
• Furaltadone and its salts
• Malachite green and its salts
Food Pathogens Control Measures in Food Products
Importers of 38 types of products listed under the Ministry of Public Health’s Notification No.
364 Re: Food Standards as Regards Pathogens B.E. 2556 (2013) must present a lab analysis
report during the food product registration process to ensure that imported products are
pathogen free or their presence does not exceed maximum specified limits stated in the
notification. The Thai FDA accepts lab analyses reports issued by government laboratories
from the country of origin, government laboratories in Thailand, private laboratories accredited
by the Thai government or laboratories accredited by international accreditation agencies.
• Yeast and Mould Level in Foods
In September 2010, the Thai FDA revised and set new tolerance levels for yeast and mold in
six food categories: beverages in sealed containers, coffee, tea, chocolate, weight control foods,
and electrolytes. The background of the notification and the established tolerance levels for
yeast and mold in foods are available in GAIN report TH0144.
32
Packaging and Container Regulations
The Thai FDA requires that all packaging and containers of food must comply with Ministerial
Notification No. 92, B.E. 2528 (1985) and No. 295, B.E. 2548 (2005). The guidelines on
packaging and containers are as follows:
(A) A container must:
• Be clean
• Not emit any heavy metal or other substances that would contaminate food in
a volume to be harmful to health
• Free of germ contamination
• Emit no food contaminating color.
(B) Containers which are made from ceramic or enameled metal must conform to subsection
(A) and meet lead and cadmium standards as described in Schedule 2 of the Ministerial
Notification No. 92 (B.E. 2528) Re: Prescription of Quality or Standard for Food Containers,
Use of Food Containers, and Prohibition of Use of Things as Food Containers.
(C) Containers which are made of plastic must conform to not only the quality or standard in
subsection (A), but also the quality or standard in Schedule 1 of the Ministerial Notification
No. 92 (B.E. 2528) Re: Prescription of Quality or Standard for Food Containers, Use of Food
Containers, and Prohibition of Use of Things as Food Containers.
(D) Plastics in the form of sheets or bags which are used as food containers must not be made
from used plastic and must not have coloring except for: a) laminate plastic, only the layer
that’s not in direct contact with the food; and b) plastic which is used for packing shelled fruits.
(E) Plastic containers of milk, milk products, and other products similar to milk products (such
as soybean milk and coconut milk) must be made from Polyethylene, Ethylene, 1-Alkene
Copolymerized resin, Polypropylene, Polystyrene or Polyethyleneterephthalate.
(F) Use of containers that have previously been used to pack or wrap fertilizers, hazardous
substances or any substance likely to be harmful to humans is prohibited.
33
(G) Use of containers that have been made to pack other products, which are not food, that bear
a design or statement that may mislead to the actual contents of a particular food is prohibited.
Ministerial Notification No. 310, B.E. 2551 (2008) lists additional measures prohibiting objects
other than food to be packed into food packaging (See GAIN report TH8082). The major
revision of this notification is as follows:
• Objects other than food shall not be packed inside food packages, except for the
purposes of food quality or standard preservation such as desiccators, oxygen
absorber, etc., in separate packages; seasonings or consuming accessories (such as
plastic spoon, chopsticks, measuring spoon, etc.).
• Objects other than food may be packed with the food packages, but only if they do
not pose a risk to humans or mislead consumers that those objects can be eaten.
Labeling Requirements
• Standard Labeling
Imported food products or domestic food products are required to display labels. For imported
foods, a Thai label must be applied where needed prior to entry and be affixed to every single
item of the food product prior to marketing. Failure to apply the label before entry will lead to
product seizure by the Thai FDA. The Thai FDA only requires pre-approved labels for
specifically-controlled foods. For other foods, the food manufacturers or food importers are
responsible to prepare a product label that complies with the Ministerial Notification No. 367
B.E. 2557 Re: Food Labeling of Prepackaged Food, which is the new food labeling law for all
prepackaged foods that became effective on December 3, 2014.
• Labelling of Modified Milk for Infants
In order to promote the importance of maternal milk and the benefits received from drinking
maternal milk for both infants and small children, the Thai FDA requires producers and
importers of modified
milk and modified milk of uniform formula for infant and children to display the following
statements on the label:
➢ The best food for infants is maternal milk owing to its full nutritional content.
34
➢ Modified milk for infants should be recommended by a physician, nurse or
nutritionist.
➢ Incorrect preparation or mixture will be hazardous for infants.
• Labeling of Cow’s Milk
Exporters must follow new labeling requirements stated under the Ministry of Public Health
Notification No. 350 Re: Cow’s Milk that governs the display and declaration statements of
certain types of cow’s milk on food labels. However, for other general labeling requirements,
the exporter can refer to the Ministry of Public Health Notification No. 194 Re: Food Labels.
• The Use of the Term “Premium” on Food Labels
The Thai Food and Drug Administration (FDA) requires food manufacturers or importers of
products which use the term “premium” on their products’ labels to meet a certain set of quality
standards and specific characteristics as stipulated under Ministry of Public Health Notification
No. 365 Re: Expression of the term “Premium” on food labels. To export products that display
the term “premium” on food labels, an exporter must submit the required documents to the
Thai Food and Drug Administration to prove that their product meets the criteria listed in the
notification. (See GAIN report TH3099).
Nutrition Labelling
The regulations on nutrition labelling are based on the Ministerial Notification No. 182 of B.E.
2541 (1998) and No. 219 of B.E. 2544 (2001). Nutritional labeling is mandatory for the
following types of food:
• Foods making a specific nutritional claim.
• Foods that make use of nutritional values in sales promotions.
• Foods that specifically target a group of consumers (e.g. students, executives, elderly
people, etc.)
• Other foods which may be specified by the Thai FDA, including potato chips, corn
chips, extruded snack foods, biscuits/crackers, assorted wafers as per Ministerial
Notification No. 305. Effective as of December 18, 2007, the Thai FDA requires
35
nutrition labeling for five groups of processed foods by displaying information that
states “Should take less and exercise for a better health.” Details of the notification are
discussed in GAIN Report TH7136.
• Exemptions of these nutrition labeling regulations (as defined in Ministerial
Notification No. 182) are infant foods, supplementary foods for infants and children,
and other types of food for which labeling requirements have been otherwise regulated;
food not directly sold to consumers; and food packed in small containers which will be
repacked and sold in a larger container. Nutrition labeling must be presented in Thai
and a foreign language is optional. The standard U.S. nutrition fact panel is not
acceptable as Thai Recommended Daily Intakes may not be identical to the United
States. In addition, differences may exist in serving size and reference amount.
In Thailand, the Food Act of B.E.2522 (1979) is the main law aimed at protecting and
preventing consumers from health hazards occurring from consumption of food. The Act
prohibits unsafe food from being produced, imported and distributed in Thailand. The Act
divides unsafe food into four categories based on the causes that make the food unsafe to
consumers:
(1) impure food,
(2) adulterated food,
(3) substandard food and
(4) other foods which prescribed by the
minister.
Other areas covered by the Act include control of packaging and labelling as well as restrictions
on advertisement.
The Food and Drug Administration under Ministry of Public Health is responsible for the
execution of the Act. The Act empowers the Ministry of Public Health to promulgate
ministerial regulations, to appoint the Food Committee and competent officers, and to set up
other activities in order to carry out the provisions of the Act. Along with the Food Act of B.E.
2522 (1979).
The ministerial regulations describe the procedures for applications of manufacturing licenses,
i mport licenses, and registration including the rates of fees, the identification card of the
36
competent officers and the labelling of food products for exports. The Food Act B.E. 2522
(1979) classifies foods into three main categories as follows:
• Specially Controlled Foods—Registrations are required for foods in this category.
Legal provisions are related to food standard quality, specifications, packaging, and
labelling requirements, as well as other aspects of good manufacturing practices. The
Food Committee may make recommendations to the Minister of Public Health
specifying specially controlled foods.
• Standardized Foods—Standard foods do not require registration but their quality and
labelling have to meet the standard requirements as specified in the Notification of
the Ministry of Public Health.
• Other Foods—Foods, raw or cooked, preserved or non-preserved, processed or non-
processed, if not listed under category 1 or 2 will be considered as general foods.
Although registrations are not required, general food products are controlled and monitored
with regard to hygiene, safety, labelling and advertisement. Foods in this category may be
subdivided into (a) foods that must bear standard labels and (b) other general foods.
The control measures for each category of foods differ; with measures for “Specially
Controlled Foods” being strictly controlled. Before producing or importing such foods, the
application for product registration is required. For standardized foods, the application for such
permission is not required, but they must be produced up to the prescribed quality or standard.
For labelled foods, however, the main objective is to control the labelling in order to avoid
misleading or cheating of consumers.
The Food and Drug Administration (FDA) of the Ministry of Public Health and the Provincial
Offices of Public Health is responsible for the enforcement of the Food Act as well as legal
food control operations with the support of food analytical services of the Department of
Medical Sciences, Ministry of Public Health. The FDA also has the responsibility to ensure
that the development of food safety control measures corresponds with international standards.
37
Table: Acts in various areas of food safety in Thailand
38
REVIEW OF PREVIOUS STUDY
Modern food safety policy came into being at the turn of the twentieth century in response to
scandals in the meat packing and food processing industries (Sinclair 1906). A second
generation of policy is emerging now, also driven by scandals and crises of trust, including the
early 1990s’ E. coli outbreak in the United States and the BSE scandal of the late 1990s in the
UK. Behind the current crises lie economic and technological transformations in both food and
the food supply system. Institutions are rushing to catch up with the implications these changes
have for public health risks.
The first generation of food safety law was characterized by command and control forms of
safety regulation. Policy was nationally focused and relied on early twentieth-century industrial
management practices such as continuous line inspection, visual product inspection, and
detailed specification of approved hygiene practices. At the heart of this second generation of
food safety policy is an emerging global consensus on the need for a preventive, public health
focused policy that fosters integrated management of foodborne hazards from farm-to-fork.
This consensus calls for use of modern science-based risk management instruments that
enhances efficiency by more accurately targeting public actions and by allowing firms
flexibility in how they achieve public health goals rather than relying on narrowly prescriptive
command and control policies. While the broad vision for this second generation of policy is
clear, much of the detail has yet to be worked out. Economists have a significant role to play
in this process.
Indian food regulations under the Ministry of Food Processing Industries was set up in July,
1988 to give an impetus to development of Food Processing Sector in the Country. The
Ministry is concerned with formulation and implementation of the policies and plans for the
food processing industries within the overall national priority and objectives. The Ministry has
taken a number of initiatives to promote investment in food processing sector. The Food safety
and standards (FSS) rules required under the Food Safety and Standards Act, 2006 (FSSA) are
being framed by the 23-member Food Safety and Standards Authority (FSS Authority). Under
the act the FSS authority would function as an apex body to implement the rules. The objective
of FSSA is to consolidate the laws relating to food, establish FSS Authority for laying down
science-based standards for articles of food, regulate the manufacture, storage, distribution,
sale and import of food products, and ensure availability of safe and wholesome food for human
consumption.
39
The Indian food processing industry is regulated by several laws which govern the aspects of
sanitation, licensing and other necessary permits that are required to start up and run a food
business. The legislation that dealt with food safety in India was the Prevention of Food
Adulteration Act, 1954 (hereinafter referred to as "PFA"). The PFA had been in place for over
five decades and there was a need for change due to varied reasons which include the changing
requirements of our food industry.
(Source: Indian Laws Governing the Food Industry in India – Revisited Vinay Vaish)
The first hand literature is provided by the existing piece of legislature, the Food Safety and
Standards Act, 2006. This act has consolidated the laws relating to food and to establish the
Food Safety and Standards. This act has triggered the new era in food legislations. The
discussion, food safety summits, commentaries, conference proceedings, workshops, and
debates on while formulation if this act had helped to understand the approach, methodology
and mechanism of it. The previous legislations, cases had further helped to understand the key
issues before the government to bring the new one. The rules passed under the FSS Act, 2006
also helps to understand the administrative and procedural mechanism for regulations.
Apart from the same, the literature available on World Health Origination webpage is very
important as it give the global standards and developments. The guidelines provided by various
nations are also very helpful.
From 1958 to the mid-1990s, the focus of European food law was to reduce barriers to creating
an integrated internal market for foods (van der Meulen and van der Velde 2008; Alemanno
2006). Uncertainty about product content, not food safety was viewed as the major barrier to a
single food market. The BSE crisis and other foodborne illness crises of the mid- to late 1990s
changed this perspective (van der Meulen and van der Velde 2008). The nature of BSE—a
fatal, neurodegenerative disease related to scrapie in sheep—and the way that crisis was
handled had a significant impact on subsequent legislative reform. At the time it was identified,
the British government maintained that BSE, like scrapie, was not transmissible to other species
(Prusiner 1991). By the late 1980s, transmission among cattle was traced to the presence of
animal offal and bone meal in cattle feed. Britain banned this practice in1988 and the EU
banned importation of beef offal from Britain. Scientific evidence began to mount that BSE
was being transmitted to humans (Krapohl 2008). Britain continued to maintain that this was
not the case until March 1996 (van der Meulen and van der Velde 2008). The European
40
Commission (EC) banned export of cattle and cattle products from the UK several days later.
A 1996 EU Committee of Inquiry found that the structure of EU food safety governance that
allowed domination of decisions by a single member state, politicization of science, and lack
of transparency contributed to the inability of the EU to respond to the crisis quickly (European
Parliament 1997). Subsequent European food safety crises contributed to pressure for
immediate action (van der Meulen and van der Velde 2008; Holland and Pope 2004).
Recommendations for structural change followed quickly in the form of a Green Paper in April
1997 and a White Paper on food safety in January 2000 (EC 1997, EC 2000).
The White Paper laid out a roadmap for EU legislative reform guided by five central principles:
clearly defined food safety responsibilities for all actors; traceability of food, feeds, and food
ingredients to their sources; risk analysis as the framework for science-based policy;
transparency and separation of scientific analysis from risk management; and use of the
precautionary principle to guide risk management (Halkier and Holmes 2006). To reduce the
role of economic interests in food safety policy decisions, responsibility for risk assessment
and scientific advice would lie with a new European Food (Safety) Authority and responsibility
for risk management would lie with the European Commission. A set of 84 legislative and
policy initiatives was outlined. The goal was to make European food law more coherent and
comprehensive and to strengthen enforcement and make it more consistent across countries
(van der Meulen and van der Velde 2008).
Several studies have examined the European food safety policy reform movement of the 1990s
from the perspectives of law, political science, public administration, and sociology, but few
from an economic perspective (Halkier and Holm 2006; Ansell and Vogel 2006; Alemanno
2006; Vos and Wendler 2006). The most fundamental change in the E.U. system has been
recognition of the central role that food safety and consumer protection play in integration of
the European food market and with this adoption of risk analysis as a structure to shape and
bring transparency to conflicts between the goals of integration and maintenance of diverse
food cultures and other local and national values (Alemanno 2006). The EFSA has
responsibility for conducting scientific assessment of new food safety policy, but national
competent authorities do as well. While both the EC and national authorities are required to
take account of EFSA scientific assessment, they are not bound by it. While many food safety
issues are now addressed by EU-wide regulation, not all are and in the absence of EU-wide
regulation, food is deemed safe and marketable across the EU if it meets the national safety
41
requirements. As Alemanno points out “a claim by a domestic food authority that a certain
good is safe or unsafe is likely to involve not only an assertion about science, but also about
the willingness of this country to bear or not bear the level of risk considered acceptable in
order to continue or reject a certain local tradition” (Alemanno 2006: 254). Of course, national
decisions may also be driven by a desire to protect local economic interests. In the case of
conflicting scientific opinion, it will be up to the European Court to determine the balance
between local, national and Europe-wide interests. It remains to be seen what balance is
ultimately worked out between national and EU concerns.
Elements of National Food Safety Policy in UK
• farm-to-table food safety authority lies with Food Standards Agency
• GFL food and feed law implemented by FSA
• emphasis on public health and consumers
• risk management lies with an agency
• risk assessment with agency committees
Source: UK House of Commons 1999; HM Treasury 2003; Slorach 2008; interview with
Derrick Jones, chief economist FSA, 2009
Globalization has brought many benefits to consumers, including more varied and nutritious
food supplies throughout the year, but it has also complicated management of both infectious
and noninfectious foodborne hazards. In developing countries, globalization has helped
increase incomes. Globalization has also fostered industrialization and urbanization, which can
strain capacity for adequate sanitation and safe food handling (Kaferstein et al. 1997; WHO
2002). It can also lead to more rapid spread of foodborne disease. Poor sanitation in developing
countries can result in contamination of food exports to developed countries, as happened in
the 1996 Cyclosporiasis outbreak in the United States associated with Guatemalan raspberries
(Katz et al. 1999; Calvin et al. 2003). But trade may also spread foodborne pathogens. between
developed countries, as in the spread of BSE from Britain to Japan in 2001, or from developed
to developing countries (McCluskey et al. 2005).
Food safety policy has a long history of using risk analysis to guide public decisions. A study
by U.S. Food and Drug Administration (FDA) toxicologists in the mid-1950s introduced safety
42
factors to establish acceptable daily intake of food additives on the basis of acute toxicity, an
approach still applied today (Lehman and Fitzhugh 1954).
Broader government commitments to greater economic integration have had and will continue
to have significant impact on food safety policy. The General Agreement on Trade and Tariffs
(GATT), negotiated in the wake of World War II, has and continues to provide the cent legal
structure for international trade. Its goal is to liberalize trade through successive rounds of
negotiation guided by the principals of equal treatment for trading partners, transformation of
nontariff barriers to tariffs, and negotiation to reduce tariffs over time (GATT 1947, Art. I).
GATT recognizes limited exceptions to its general requirements. One of the most important is
the exception for actions required to protect health (GATT 1947, Art. XX).
43
RESULTS & DISCUSSIONS
Every nation needs an effective food legislation and food control service to promote a safe,
honestly presented food supply, and to protect consumers from contaminated, adulterated, and
spoiled foods. Generally, the food law is divided into two parts: a basic food act and
regulations. The Act itself sets out broad principles, while regulations contain detailed
provisions. The principles or general provisions to be included in food law are primarily: basic
purposes and scope, definitions of basic concepts, inspection, enforcement, biological and
chemical contaminants, packaging and labelling, and procedures for the preparation and
amendment of the regulations for implementation of the law. Food law is based on scientific
studies. Harmonization of Food Law on the international level is a worldwide trend from the
late twentieth century. The introduction of integrated food law provides the much required ‘one
law-one regulator’ platform for raising the food safety standards of India to match global
standards. Its speedy and effective implementation is quickly warranted to put India onto the
global food map. This would require an enabling implementation environment focused on
creation of transparency, awareness creation, capacity building, product traceability,
developing right infrastructure and extensive R&D capacity so as to match the dynamically
changing requirements of food safety and standards. Over a period of time the developed
importing countries have been making changes in their regulatory policies which are consumer
centric. The comparison of the regulatory regimes of the selected economies shows that the
regulations of EU have been stringent since 2002 with the adoption of traceability and
precautionary principles. In Thailand, there are a number of variations in the rules and
regulations governing specific categories and types of food, the general guidance by setting out
the general penalties and repercussions in regard to noncompliance in the areas are as follows:
Compliance area Penalty
Product registration Subject to imprisonment of not more than 2 years or a
fine of not more than THB 20 000, or both
Variations in product registration Subject to imprisonment of not more than 1 year or a fine
of not more than THB 10 000, or both
Manufacturing Subject to imprisonment of not more than 3 years and a
fine of not more than THB 30 000, or both
Advertising Subject to imprisonment of not more than 3 years and a
fine of not more than THB 30 000, or both
Labelling Subject to a fine of not more than THB 30 000
44
CONCLUSION
Every nation needs an effective food legislation and food control service to promote a safe,
honestly presented food supply, and to protect consumers from contaminated, adulterated, and
spoiled foods. Harmonization of Food Law on the international level is a worldwide trend from
the late twentieth century. The laws discussed of the select economies are essentially dynamic
in nature and have evolved from over time in the interest of consumer. The experience of each
of the select nations show that in totality their different levels of strictness is likely to entail
different set of issues for the exporters.
Organizations such as the Bureau of Indian Standards and the Regulatory body- FSSAI, in
principle endeavour to include various groups of stakeholders in the standards setting process.
Also, the inherent structure of technical committees, their composition at national and
international level gives us a glimpse into the different actors shaping this process. India’s pace
of development is challenged by restrictions on the importation of food into developed
countries on the grounds of food safety. The country’s food safety regime needs more effective
implementation to meet best practice internationally. Alignment of India’s food standards with
international norms of food safety will both increase and stimulate domestic production and
economic development, while protecting consumers at home – and widen the overseas
consumption base.
Till 1990s the policy emphasis was on free flow of products rather than safety measures. With
the onset of certain epidemic instances lead to rethinking on the food safety regulations. EFSA
was constituted in 2002 with task providing scientific advises, including risk management,
operation of the Rapid Alert System. Quick dissemination of information and networking of
national agencies. The national food safety legislations within EU were harmonized with an
emphasis on the following areas so as to cover the entire food chain with respect to the food
policy. A comprehensive integrated approach was followed which included stages like feed
production, primary production, processing storage, transportation and retail stores, to clearly
attribute primarily compliance responsibility to industry produces and supplier, strengthening
of enforcement at all borders, Introduction of precautionary principle which meant that there
could be new regulations put even if there was an imminent danger perceived, empowerment
to take rapid , effective safeguard measures to deviance, like the RASFF, dissemination of
information regarding food safety policy information to consumers, unification of food safety
across EU and strengthening of National Surveillance and control system, to evaluate the
45
efficacy of law enforcing agency, taking into account the best practices like the codex,
introduction of concept of traceability through record keeping of the ingredients through proper
maintenance of records, risk analysis was made the foundation of food safety system, building
a robust and integrated data base on issues relating to food safety.
Thai food regulations have evolved for over 100 years to improve the quality and safety of food
products. Thai nutrition label policy follows the international Codex Alimentarius guidelines.
A good impact on dietary behaviour, and eventually on health and nutrition, remains the elusive
goal. Thai food label regulation has changed in parallel with social change and economic
development for the past century, while the country underwent a transition from a traditional
subsistence agricultural society to a modern manufacturing middle income state. The evolution
of the Thai food industry and rules that govern domestic and international trade have interacted
with economic development in prosperous ways creating lots of export opportunities to various
destination round the globe.
46
REFERENCES
• FAO/WHO (1976). Guidelines for Developing an Effective National Food Control
System. Rome: FAO.
• Food and Drug Administration, 1979. Food Act B.E. 2522 (1979), Bangkok.
• Food safety & Standards Act, FSSAI 2011
• Food Standards Agency (FSA), 2007. Guidance notes for food business operators on
food safety, traceability, product withdrawal and recall. July 2007. UK Food Standards
Agency, London, UK. Available at:
www.food.gov.uk/multimedia/pdfs/fsa1782002guidance.pdf.
• United States Department of Agriculture, Foreign Agricultural Services, Thailand Food
and Agricultural Import Regulations and Standards Report, FAIRS Annual Country
Report
CITIATIONS
• Alemanno, A., 2007. Trade in food: regulatory and judicial approaches in the EC and
the WTO. Cameron May, Cambridge, UK.
• Alemanno, A., 2008. The European Food Safety Authority at five. European Food and
Feed Law Review 1: 2-24.
• Ansell and Vogel, The Contested Governance of European Food Safety, UC Berkeley
Working Papers (2006)
• Calvin et al., Produce, food safety, and international trade (2003)
• Codex Alimentarius Commission, August 18, 2016. Codex Members and Observers
from: http://www.fao.org/fao-who-codexalimentarius/members-observers/en/.
• Debra Holland, Helen Pope, EU Food Law and Policy (2004)
• European Commission (EC), 2010. Guidance on the implementation of Articles 11, 12,
14, 17, 18, 19 and 20 of Regulation (EC) No 178/2002 on General Food Law.
Conclusions of the Standing Committee on the Food Chain and Animal Health, 26
January 2010. Brussels, Belgium. Available at:
http://ec.europa.eu/food/food/foodlaw/guidance/docs/guidance_rev_8_en.pdf.
• GATT 1947. The General Agreement on Tariffs and Trade (GATT 1947)
• Halkier and Homes, Shifting responsibilities for food safety in Europe: An introduction
(2006)
47
• Kaferstein et al., Foodborne Disease Control: A Transnational Challenge, World Health
Organization, Geneva, Switzerland (1997)
• Krapohl, S. (2008) Risk Regulation in the Single Market. The Governance of
Pharmaceuticals and Foodstuffs in the European Union
• Lehman AJ, Fitzhugh OG. 1954. 100-Fold margin of safety. Assoc Food Drug Officials
US Q Bull. 18:33–35.
• McCluskey et al., Reducing Chronic Absenteeism: An Assessment of an Early Truancy
Initiative (2005)
• Prusiner, Jun 14;252(5012):1515-22. Molecular biology of prion diseases (1991)
• Upton Sinclair, The Jungle, Penguin books, 2006 (1906)
• Van der Meulun, B.M.J. and Van der Velde, M., 2008, European Food Law Handbook,
Wageningen Academic Publishers, Wageningen, the Netherlands

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Assessment of food laws in India, UK and Thailand

  • 1. ASSESSING FOOD LAWS AND REGULATIONS: A COMPARATIVE STUDY OF INDIA, UNITED KINGDOM & THAILAND COURSE: FOOD LAWS & LEGISLATION (APFE-614) Study report submitted under the guidance of Er. Hena Imtiyaz & Er. Avanish Kumar (Assistant Professors, Dept of Food Process Engg.) by Abdul Rehman (ID 16BTFT070) in the partial fulfilment of the award of degree of Bachelor of Technology in Food Technology Department of Food Process Engineering Vaugh Institute of Agricultural Engineering and Technology Sam Higginbottom University of Agriculture, Technology and Sciences May 2020
  • 2. 2 ACKNOWLEDGEMENTS It is with immense pleasure I would like to express our deep sense of gratitude and sincere thanks to all the people whose combined efforts results in completion of task. To start with, I would like to present my deep gratitude to Er. Hena Imtiyaz & Er. Avanish Kumar (Assistant Professors, Department of food Process Engineering, SHUATS) who gave the opportunity to gain knowledge on food laws and regulations by drafting special report on Comparative assessment of food laws in India, UK & Thailand. I would also thank Prof. (Dr.) Sheen Moses (Head, Dept of Food Process Engineering, SHUATS) and University Academic Council for giving their kind decision towards student welfare in this crucial time when the whole world is suffering from pandemic with no positive signs till date. Lastly, I am obliged to my parents for their blessings & love and the support without which this target could not be accomplished. ABDUL REHMAN
  • 3. 3 ABSTRACT Food regulations and standards in the leading countries are highly developed, and are perceived to be more stringent, based on scientific risk management and proactive introduction of new regulatory standards for previously unknown or unregulated hazards. Every nation needs an effective food legislation and food control service to promote a safe, honestly presented food supply, and to protect consumers from contaminated, adulterated, and spoiled foods. Indian laws concerning standards of food and its manufacture, sale and import were overhauled in the year 2006. Encompassed primarily in the Food Safety and Standards Act, 2006 (FSS Act) and related Rules and Regulations, the laws were introduced stage wise from the year 2007 onwards. They intended for the FSS Act to take care of international practices and envisaged a policy framework designed to eliminate multi departmental control and guide and regulate persons engaged in manufacture, marketing, processing, handling, transportation, import and sale of food. The Food Safety Regulation (EC) No. 178/2002 in United Kingdom ascribes a crucial role to consumer protection, setting forth the principles of transparency, traceability, and responsibility of business operators; establishing a rapid alert system and crisis management plan; and, most importantly, establishing the European Food Safety Authority (EFSA). EFSA provides scientific opinions and scientific and technical assistance, establishes surveillance procedures, promotes cooperation among food safety organisations, and plays a crucial role in risk assessment and communication. The main regulation controlling all foods in Thailand is the Food Act B.E. 2522 (1979) under the regulation of US FDA. It provides the government and officials with the authority to control domestic production and imports and exports of food products for sale, as well as provide the criteria and penalties for food business in Thailand Keywords: Food safety, Food Law, FSS Act India, EFSA, risk management, HACCP, US FDA
  • 4. 4 TABLE OF CONTENTS 1. INTRODUCTION 1.1 FOOD LAWS & REGULATIONS IN INDIA 1.1.1 Food authorities 1.1.2 Law Applicable to Manufacturers, Sellers and Consumers 1.1.2.1 Licensing and Registration 1.1.2.2 Product Approval 1.1.2.3 Food Standards and Ingredients 1.1.2.4 Labelling 1.1.3 Import Related Provisions 1.1.3.1 Licenses 1.1.3.2 Ingredients 1.1.3.3 Labelling Requirements 1.1.4 Foreign Direct Investment (FDI) Policy 1.2 FOOD LAWS & REGULATIONS IN UK 1.2.1 Emergence 1.2.2 General objectives 1.2.3 Risk analysis principle 1.2.4 Precautionary principle 1.2.5 Transparency 1.2.6 Tasks, Structure, and Operation 1.3 FOOD REGULATIONS IN THAILAND 1.3.1 Food Act of B.E. 2522 (1979) 1.3.2 Food Additives Regulations 1.3.3 Food Pathogens Control Measures in Food Products 1.3.4 Packaging and Container Regulations 1.3.5 Labelling Requirements 2. REVIEW OF PREVIOUS STUDY 3. RESULTS & DISCUSSIONS 4. CONCLUSION 5. REFERENCES & CITIATIONS
  • 5. 5 INTRODUCTION Over the last decade, there have been significant changes in the national and international regulatory frameworks governing food control, food safety and food trade. The adoption of the Codex Alimentarius as the source of international food standards by the World Trade Organization Agreement on Sanitary and Phytosanitary Measures (SPS Agreement) in 1995 has been one of the most significant recent influences on food regulation worldwide, and can be seen as an acknowledgment of the increasing globalization of food production and food trade. Worldwide outbreaks of food-borne disease, with concomitant media attention and outspoken consumer concerns, have also triggered unprecedented interest in food control and food regulation and in the country level infrastructures which govern food safety. Equally, the last decade has seen heightened interest in the intersections between food safety and other areas of agriculture which have heretofore been treated separately, such as plant quarantine and animal quarantine. Often these topics are combined under the heading “biosecurity”, which is generally understood to mean protection from the environmental, economic and human health risks of potentially harmful plant and animal pests and diseases, alien invasive species and genetically modified organisms. In a number of countries, governments have vested food safety, animal quarantine and plant quarantine authority in a single executive agency which carries out inspections “from farm to fork” and aims to protect animal, plant and human life and health. FOOD SAFETY REGULATIONS IN INDIA India Food Safety Regulations India’s food laws have had a revamping from the last few years. It has focused on – ➢ Prevention of food adulteration; ➢ Regulation for providing hygienic conditions of processing/ manufacturing; ➢ Protection of the domestic agriculture and livestock sector from pests and diseases; ➢ Inform consumers about the products they eat (such as vegetarian or non-vegetarian, maximum price to pay, etc.); and ➢ Provision of product specifications. Like all other countries, as a requirement of WTO all food safety laws are applicable to the Indian manufactures as well as foreign manufacturers, (national treatment). The “Food Safety
  • 6. 6 and Standards Act, 2006,” was enacted by the Government of India (GOI), constituted a Food Safety Standards Authority of India (FSSAI) with the objective of consolidating various food laws and establishing a single regulatory agency. The Food Safety Authority of India, (FSSAI) was created to: ➢ Lay down food standards ➢ Effectively regulate the manufacture, import, storage, distribution, and sale of food to ensure consumer safety and promote global trade ➢ Pool infrastructure, manpower, testing facilities, and ➢ Rationalize and strengthen the existing enforcement mechanism. FSSAI is responsible for fruits, meat, milk products, processed, and novel foods. The salient features of the Indian food safety laws are as follows, (FAIRS GAIN Report, 2010) ➢ A single regulatory authority, namely Food Standards and Safety Authority (FSSAI) of India was created to ensure uniform regulatory regime and standards for products. ➢ Food Safety and Standards Regulations, 2010, which has been notified to the WTO and has now been published in the Official Gazette of India (21st October, 2010). This repeals a number of individual Acts and orders pertaining to quality and packaging of food products. ➢ Indian exporters and importers conducting business in India are required to hold valid FSSAI licence though no such restrictions are placed on companies exporting food products to India. ➢ The food business operators who can be food processor, manufacturer, exporter, or importer, shall ensure that the food meets all the standards laid under the FSSAI’s Food Safety and Standards Regulations, 2010; ➢ On 1st December, 2004, the Department of Health (DOH) issued a gazette notification that lists permitted food additives in fish and fish products and microbiological requirements of seafood Under the new regulations: ➢ Importers must furnish an import declaration in the prescribed bill of entry format, disclosing the value of the imported goods. This must be accompanied by any import license and phytosanitary certificate (in case of agricultural commodities), along with documentation such as sales invoices and freight and insurance certificates. All
  • 7. 7 consignments are required to be inspected prior to clearance. The FSSAI has also authorized its officers at Mumbai, Nhava Sheva, Haldia, Kolkata, and Chennai sea ports to oversee the clearance process of imported food products; ➢ Customs officers inspect incoming consignments, draw samples, and forward the samples to FSSAI port officers, who verify that the imported food product complies with the Indian food laws. The FSSAI port officers take the samples and, based on the regulations, send the samples for required tests to FSSAI approved labs. The FSSAI port officers will issue a "No Objection Certificate", if lab analysis results show that the imported food product is in compliance with the Indian food laws. Customs officers will refer to the "No Objection Certificate" issued by the FSSAI port officers after which the consignment is released for distribution and sale in India. If the consignment does not comply with the Indian food law, then the FSSAI port officers inform the customs officers to detain, reexport, or destroy the consignment. ➢ FSSAI maintains the procedures for sampling, testing, and clearance of imported foods and all the rules and procedures as they were under the PFA Act, as amended). The procedures for sampling and lab analysis are described in Chapter IX of Food Safety and Standards Regulations, 2010. Food Authorities At the Central (federal) level, the Food Authority is comprised of senior government officials, including those from the Departments of Agriculture, Food Processing, Health, Consumer Affairs, and Commerce. The Food Authority is also comprised of representatives of the food industry, consumer organisations, food technologists/scientists, farmer organisations, and retailer organisations. The Food Authority is supported by a Central Advisory Committee, various panels and a Scientific Committee. The day to day activities of the Food Authority are carried out by a CEO and other officers and employees. In addition to the authorities at the Federal level, each State has a Commissioner of Food Safety/Health and Family Welfare and multiple officers known as “Designated Officers” who, inter alia, are responsible for processing applications for and issuing licenses. Each State also employs “Food Safety Officers” who oversee the active sampling and seizure procedure, and forward the same to Food Analysts, also
  • 8. 8 appointed under the terms of the FSS Act. The Food Analysts use recognised and accredited food laboratories for discharge of their duties. Law Applicable to Manufacturers, Sellers and Consumers • Licensing and Registration Registration is required for Petty Food Business Operators, a category constituted, inter alia, of food stall operators (even stalls of a temporary nature), itinerant vendors, those working from home-based kitchens, road-side tea vendors, etc. The implementation of the registration requirement for Petty Food Business Operators is an enormous practical challenge. Authorities are attempting to regulate those who do not even have a temporary place of business but who may move around on bicycles vending milk, or with their daily output of food produced in their home kitchens and moving on foot. A vast majority of these vendors are illiterate, unaware of the requirements of law, and have no access to newspapers or other media where the Food Authority regularly advertises various facets of law for the awareness of the public at large. Interestingly, the Licensing Regulations also seek to bring within its purview arrangements made for religious gatherings. It is not unusual in India to celebrate religious, or even personal, occasions by distributing food and/or beverages to the less privileged. Nothing in the Licensing Regulations suggests that the registration requirement is limited to places of worship which distribute food to the needy on a daily basis. While the effort to implement the registration, requirement is laudable from the point of view of controlling sanitary and hygiene conditions, even in the case of free distribution of food to the poor, it remains to be seen if such a requirement can be strictly implemented by its officials against individuals setting out to feed the poor. Separate from the registration process is the license process which is applicable to those who are not Petty Business Operators (with reference to the scale of operations). While a license for a food business is primarily obtained at the State/local level where the business is operational, for specified businesses the license is granted by at the Federal level—including for importers and food business operators operating in two or more States. Food business operators who manufacture any article of food containing ingredients or substances or using technologies or processes, or a combination thereof, whose safety has not been established through FSS Act and related regulations, or which do not have a history of safe use, or food containing ingredients being introduced for the first time into the country need
  • 9. 9 to apply for product approval separately before applying for license. The Food Authority has clarified the circumstances when a single or multiple licenses would be required for the same premises. If the products being handled at a single premise can be treated as connected then only one license will be required. According to the Food Authority, if processing of meat, milk, fruits and vegetables is being undertaken in the same premises, separate licenses must be obtained as each activity will be done in separate portions and the businesses are not connected. However, where the premises have facilities for fruit and vegetable processing as well as a store along with it, since these are connected activities, only one license would be required. Indian food laws do not specify requirements for separate facilities for nuts and/or soy or other ingredients which are known internationally to cause allergies, or labelling requirement concerning traces of such ingredients—this may be due to a general perception that such allergies are uncommon in the Indian population and/or the fact that there may be inadequate data concerning the existence of such allergies in the Indian population. • Product Approval Foods for which standards are not prescribed under the FSS Act and related regulations or which contain ingredients or substances whose safety has not been established, or which do not have a history of use in India, need to apply for product approval separately before, applying for license. The product approval requirements are either relatively relaxed or more arduous depending on the category into which the food products fit. For instance, if the products do not contain plants or botanicals or animal origin substances and the safety of the ingredients are known and permitted under the applicable FSS regulations/Codex and other regulatory bodies like the EU/USFDA/FSANZ the products would be granted approval as a matter of formality with relative ease. However, if the products contain plants or botanicals or animal origin substances irrespective of the safety of the ingredients being known and permitted under the applicable FSS regulations/Codex and other regulatory bodies like the EU/USFDA/FSANZ, the application form for such products is not only more detailed requiring exhaustive information and documents, the timelines typically are extended before the approval or No Objection Certificate (NOC) is granted. The NOC serves as an interim permission to place the food in the market for a year during which time the product is assessed by the Scientific Panel for safety. If the safety assessment is prolonged beyond a year, the NOC is extended. There is a separate identified category of foods referred to as “traditional/ethnic” food which is treated in a more relaxed fashion and is exempt from the requirement of product approval—these foods
  • 10. 10 range from traditional savouries such as spice fried dals (lentils/pulses) to indigenous sweets such as gulab jamuns. While the FSS Act is intended to take care of international practices and the Food Authority, when dealing with product approval, refers to acceptability under international regulatory bodies such as EU/USFDA/FSANZ, there are certain challenges in maintaining complete uniformity for well-established international products. For example, if nutritional supplements are to be introduced into India, their acceptability in other regions for years does not necessarily mean an automatic acknowledgment of safety and hence approval. This is especially so in the case of added minerals and vitamins where the ICMR guidelines stipulating Recommended Dietary Allowance (Indian RDA) are the sole acceptable standard in India, and any deviations from the Indian RDA are liable to be rejected. No doubt, the Indian RDA being based on Indian population should take precedence over any other country’s RDA. However, even when one accepts the supremacy of the Indian RDA for the Indian population, there are certain challenges in such universal implementation which may have been unforeseen by the Food Authority. The Food Authority does not clarify the treatment of products aimed at those who are outside the mean population that the Indian RDA is based on. Any nutritional supplement for, say, the elderly (whose nutritional requirement may merit additional vitamins or minerals) will fall afoul of the Indian RDA (which are calculated on the basis of “men between 18–29 years of age and weighing 60 kg with a height of 1.73 m with a BMI of 20.3 and who are free from any disease and physically fit for active work”). There is no denying that with increases in age the requirement for minerals and nutrients in the body change due to various factors such as loss of appetite, difficulty in absorption due to medicine intakes, etc., and as a result there may be a requirement for increased nutrient intake. Some examples of the differences between the Indian RDA and the international RDA requirements follow: • For Vitamin C the Indian RDA limit is 40 mg, while the limit prescribed in the European Union Directive 90/496/EEC on nutrition labelling for foodstuffs as regards recommended daily allowances, energy conversion factors, and definitions is 80 mg; • For Vitamin B12 the Indian RDA limit is 1 μg, while the limit prescribed in the European Union Directive 90/496/EEC on nutrition labelling for foodstuffs as regards recommended daily allowances, energy conversion factors and definitions is 2.5 μg;
  • 11. 11 • For Selenium the Indian RDA limit is 50 μg, while the limit prescribed in the European Union Directive 90/496/EEC on nutrition labelling for foodstuffs as regards recommended daily allowances, energy conversion factors, and definitions is 55 μg. It may be more appropriate for the Food Authority to summarily reject products containing vitamins and minerals beyond the Indian RDA limits ordinarily but make allowance for variation on account of the target consumer. The reference to international guidelines would have then perhaps be appropriate, relevant, and real, taking into account products aimed at a specialised population in countries where the safe consumption of the products has been established. • Food Standards and Ingredients Standards including permitted ingredients and quantities for ingredients are prescribed for about 13 broad categories of foods (e.g.: dairy products, fats and oils, fruit and vegetable products, cereals and cereal products, meat and meat products, fish and fish products, spices and condiments, sweets and confectionary, sweetening agents, beverages, etc.). Each category comprehensively covers specific food items totalling about 150 identified food and beverage items ranging from globally identifiable items such as different types of cheese, chewing gums, and chocolates to more locally relevant products, such as ghee (in the milk products category) and jaggery (categorized under sweets and confectionary). Additionally, standards are prescribed for food additives such as permitted colours, artificial sweeteners, preservatives, anti-oxidants, emulsifying agents and anticaking agents. For example, only lecithin, ascorbic acid, and tocopherols are generally permitted for use as anti-oxidants. Further, colouring agents are classified into the following sub-categories: (i) Natural Colouring Matters such as beta carotene, chlorophyll, saffron, curcumin, caramel etc. are generally permitted to be used; (ii) Inorganic Colouring Matters and pigments are generally not permitted for use unless otherwise provided in for the Food Additive Regulations; and (iii) Synthetic Food Colours such as ponceau, carnosine etc. are permitted to be used only in specified food products. Further, the Food Standard Regulations classifies ‘Preservatives’ into two classes as follows:
  • 12. 12 (i) Class I preservatives such as common salt, sugar, spices, vinegar, honey and edible vegetable oils, etc., which can generally be used; and (ii) Class II preservatives which are restricted for use in specified foods to specified limits. There is also a restriction on using more than one Class II preservative even in the foods where individual Class II preservatives are permitted. The Flavouring Agents and Related Substances are permitted to be used subject to appropriate labelling and are classified as follows: (i) Natural Flavours and Natural Flavouring substances; (ii) Nature-Identical Flavouring Substances; and (iii) Artificial Flavouring Substances—covering those substances which have not been identified in natural products intended for human consumption, either processed or not. At the opposite end of the requirements of specific standards is the category of Proprietary and Novel Foods. This category covers all food for which standards have not specifically been prescribed. However, regulatory restrictions concerning permissible ingredients and limits on the use of certain other ingredients all apply to Proprietary Foods. The Food Standard Regulations also identify the foods which can undergo irradiation, the minimum and maximum doses of irradiation, and the facilities at which foods can undergo irradiation. • Labelling The food laws related to labelling are primarily contained in the Packaging and Labelling Regulations which are read along with the LMPC Rules. The LMPC Rules provide for the manner of packaging of commodities and the declarations to be made on packed commodities. The LMPC Rules expressly provide that no person shall pre-pack, or cause or permit to be pre- packed, any commodity for sale, distribution, or delivery unless the label is securely affixed and the requisite declarations have been made on the package in which the commodity is pre- packed. The Packaging and Labelling Regulations stipulate certain mandatory information, declarations, and specifications to be provided on the labels of every pre-packaged food proposed to be imported, stored, and/or sold in India. As per LPMC Rules, separate labelling requirement apply to wholesale packages which consist of multiple packages which can then
  • 13. 13 be retailed individually. Since the labelling requirement for retail packages are extensive, the declarations for wholesale packages are more relaxed, requiring only the name and the address of the manufacturer, importer (and in some instances the packer), the identity of the commodity contained, and the total number or weight of the retail package (s) contained in the wholesale package. ➢ “Vegetarian” or “Non-Vegetarian” Food Labelling This requirement reflects the vast population of Indians who are vegetarian for religious reasons. It is not only the use of meat products per se that require a food to be labelled “non- vegetarian”, but even ingredients such as gelatine (which traditionally has been sourced from animal products) would lead to a food item being labelled nonvegetarian”. Gelatine itself is a standardised ingredient: i.e. standards are prescribed for it and special labelling requirement (other than “non-vegetarian”) applies to the use of gelatine. The declaration to the effect that a food is non-vegetarian or vegetarian is made by a symbol with the former being identified by a brown colour filled circle inside a square with brown outline and the latter by similar symbol in green colour. From a consumer information standpoint, both the Packaging and Labelling Regulations as well as the LMPC Rules specify details such as, inter alia, the quantity declaration being free from printed information on all its sides by specified space, the heights of numerals made in the declarations, and the label’s proportion. in comparison to the principal display panel (with the principal display panel being pretty much the entire package/container of food). There are further requirements concerning the non-vegetarian or vegetarian symbols, including the diameter of the sides of the square and size of the symbol in comparison to the principal display panel, and for the symbol to be prominently displayed on the labels having a contrasting background on the principal display panel, and being placed in close proximity to the name or brand name of the products. ➢ Other Information, Declarations and Specifications Required to be Stated In addition to the non-vegetarian or vegetarian declaration, some more India specific labelling requirements include: (i) the labelling language must be either English or Hindi (ii) the format for declaration of maximum price at which the product may be sold to the end consumer viz. ‘MRP Rs. . .. . .incl. of all taxes’ or Maximum or Max. retail price. . .. . . inclusive of all taxes’ or in the form.
  • 14. 14 The Packaging and Labelling Regulations mandate the use of the International System of units in declaring the net quantity of the commodity on the labels including kilogram and grams. Other information, declarations and specifications required to be stated on the labels of foods include: ➢ Name/description of the Food Product. List of Ingredients—in the mode and manner prescribed including, but not limited to: listing the name of the ingredients in descending order of their composition by weight or volume, as the case may be; declaration of constituents of compound ingredients, etc. Nutritional Information per 100 g or per serving of the product with specifics of kcal, protein, carbohydrates from sugar, and fat. In cases where a nutrition or health claim is made, depending on the kind of claim, a declaration may need to be made concerning the amount of fatty “Non-Vegetarian Declaration” (brown) “Vegetarian Declaration” (green) acids, monounsaturated fatty acids, and polyunsaturated fatty acids and/or cholesterol and/or trans fatty acids. Further standards are specified as to the amount of trans fats or saturated fats that may be present in a product for a health claim of ‘trans-fat free’ or ‘saturated fat free’. ➢ Declaration Regarding Food Additives—under the following class titles together with the specific names or recognised International Numerical Standards (INS): Acidity Regulator, Acids, Anticaking Agent, Antifoaming Agents, Antioxidant, Bulking Agent, Colour, Colour retention Agent, Emulsifier, Emulsifying Salt, Firming Agent, Flour Treatment Agent, Flavour Enhancer, Foaming Agent, Gelling Agent, Glazing Agent, Humectant, Preservative, Propellant, Raising Agent, Stabilizer, Sweetener, Thickener. There are specific recommended declarations for the extraneous addition of colouring matters related to the sub-category of the colouring matter used. If the statement is displayed along with the name or INS number of the food colour, the colour used need not be declared in the list of ingredients. Similarly, there are specific recommended declarations for the extraneous addition of flavouring agents and also separately for cases where both colour and flavour are used.
  • 15. 15 Instructions for use including for reconstitution, if necessary, to ensure correct utilization of the product. ➢ Name and Complete Address of the Manufacturer and Packer. If the address of the manufacturer and the manufacturing unit are different, both have to be specified. The name and address of the packer is required when the manufacturer is not the packer. In cases of contract manufacturing for some other manufacturer or company under the latter’s brand name, the label will need to state the name and complete address of the manufacturing or packing unit, as the case may be, and also the name and complete address of the brand name owner for, and on whose behalf, the product is manufactured or packed. ➢ Contact Details of the person who can be contacted in case of consumer complaints. ➢ Lot/Code/Batch Identification, enabling tracking in manufacture and identification after distribution: The date, month and year of manufacture, packing or pre-packing of the product. ➢ Best Before and Use By Date in any one of the three specified formats. ➢ The net weight or number or measure of volume of contents which would need to exclude the weight of wrappers and materials of the package. ➢ Additional and specified declarations need to be made for certain foods such as for infant foods, irradiated foods, artificial sweeteners, food colours, edible oils, drinking water, foods containing monosodium glutamate, etc. The LMPC Rules and the Packaging and Labelling Regulations mandate clear and unambiguous declarations including specifying instances where declarations must be printed in a colour which contrasts the background. The LMPC Rules and the Packaging and Labelling Regulations prescribe any description or presentation or labelling that is false, misleading or deceptive or is likely to create an erroneous impression regarding the product’s character in any respect. The aforesaid rules and regulations stipulate against use of words such as “recommended by the medical profession” or any words which imply or suggest such recommendation. They direct against declarations of quantity with words, or expressions which may lead to exaggerated, misleading or inadequate impressions, such as the use of the following words or phrases: ‘minimum’, ‘not less than’, ‘average’, ‘about’, ‘approximately’, etc. The required declarations need to be printed on each label, as LMPC Rules do not permit affixation of individual stickers on the package for altering or making declarations. The only
  • 16. 16 exception is that a sticker may be used for reducing the retail sale price of a commodity, as long as such a sticker does not cover the original retail sale price stated on the package. ➢ Exemptions from Labelling Requirements: By Legal Provisions and by Practice Packaging and Labelling Regulations prescribe, inter alia, limited and specific exemptions from labelling requirements for packaged products if the surface area of the package is not more than 100 square centimetres. There is additional relaxation for packages whose surface area is less than 30 square centimetres. Certain exemptions also apply to a package which qualifies as a ‘multi piece package’, i.e., it is a package containing two or more individually packaged or labelled pieces of the same commodity of identical quantity, intended for retail either in individual pieces or as a whole. While the aforesaid labelling exemptions are provided in law, certain labelling requirements are routinely not enforced in practice, leading to a perception that exemptions have been extended by the authorities. The risk of relying on such practice is that at any point in time, the Food Authority, and hence other government departments, may decide otherwise. This sudden decision could be the result of economic/foreign policies which cannot be foreseen. For example, the requirement to label beverages, especially imported alcoholic beverages had not been enforced by the Food Authority for some time. However, as per recent reports there are containers of imported Scotch whisky and wines pending clearance at customs since the Food Authority had taken a decision to enforce labelling provisions for such beverages. While European manufacturers and exporters have reportedly dug in their heels concerning labelling, the recent stringent application may also be a direct response to the EU banning import into Europe of Indian mangoes and other produce products. The Indian authorities’ stance, that it does not matter what the US and EU prescribe since Indian laws provide otherwise, while technically sound, does seem contrary to one of the objects and reasons for the new Indian food laws— moving towards international practices. If world over the consumer can be expected to know what Scotch whisky and wine are comprised of, or at least not be the worse for wear without that knowledge, then the Indian labelling requirements being made applicable to imported wines and whiskeys seems excessive. ➢ Trademarks Protection
  • 17. 17 Products of various food brands from across the world have become a common sight in the marketplaces and dining rooms in India. The effective branding strategies for these products are essential ensuring their distinctiveness and making them easily recognisable to consumers and to help in achieving and sustaining a competitive market share. Given the appeal of these global/Indian brands in the food sector, trademark protection has become a growing priority for the major players in the food sector. Trademarks can include words, logos, shapes (of the food product itself or its packaging), slogans, specific colours and sounds. Some of the more well know food brands in India include McDonalds, Coca Cola, Maggi, Dominos, Cadbury, and many others. In terms of the Trade Marks Act, 1999, proprietors of these brands are afforded adequate protection against the infringement of the rights in their respective brands. Below are some recent examples of protection by the courts in India, of some well-known food brands: 1. Cadbury Ltd vs. Tims Foods Private Ltd This suit was filed by Cadbury against Tims Food, seeking permanent injunction against Tims Food from infringing Cadbury Dairy Milk ‘eclairs’ labels/ wrappers. The Court ruled that the trade dress/wrapper adopted by Tims Foods was deceptively similar to that of Cadbury and concluded that there had been undue enrichment to Tims Foods to the detriment of Cadbury. Injunction was granted to Cadbury and it was awarded damages amounting to ₹ 500,000/-. 2. The Coca-Cola Company vs. K.M. Salim The High Court of Delhi held, that when a trademark is identical to a registered trademark and goods/services for which it is used are also identical to goods or services for which registration has been granted, then the Court shall presume that it is likely to cause confusion on part of public and therefore granted injunction to the Coca-Cola Company. 3. Heinz Italia vs. Dabur India Ltd. Injunction was granted against marketing of a product under the brand ‘Glucose-D’, as the brand was deceptively similar to ‘Glucon-D’, a registered trade mark of Heinz Italia. Import Related Provisions
  • 18. 18 Pursuant to obtaining an Import–export Code (IEC) under the Export–import Policy of India from the office of the Director General of Foreign Trade, importers may import food for which there are few additional requirements as well as some relaxation of existing requirements. • Licenses As discussed above, all importers would require a license from the Food Authority at the Federal level. • Ingredients The provisions of the FSS Act apply in totality with reference to the use of ingredients, and restrictions for all imported food items. • Labelling Requirements A food item’s country of origin needs to be stated on the labels of imported foods. If a food product has undergone processing in a second country which changes the nature of the food product, then the country in which the processing is performed is considered to be the country of origin for the purposes of labelling. In the case of imported foods, the name and address of the importer in India is also required. Foreign Direct Investment Policy as Applicable to the Food Industry The Government of India in general permits investments in the food processing sector under the “automatic route”, i.e., without the requirement for further approvals for investment. However, there are certain categories of food products which are reserved for the micro and small-scale sector where foreign direct investment is eligible for the automatic route only for up to twenty-four per cent (24 %) foreign direct investment.
  • 19. 19 FOOD REGULATIONS IN UK Food scarce of the 1990s, the Bovine Spongiform Encephalopathy (BSE) and the dioxin contamination in Belgium made the European Commission (EC) to reanalyse its food safety regulations. In 1997, the EC issued a green paper concluding that the earlier food legislations fell short of meeting the needs of the consumers, producers, and manufactures of food products. In 2000, recognizing the need for measures to deal with food, the Commission decided that an independent European Food Safety Authority (EFSA) would be a best way to ensure food safety (White Paper on Food Safety, 2000). It was decided to introduce the concept of scientific risk-based assessment for decisions on regulations. Till then, the EU policy intent was to eliminate trade barriers within the community and its goal was free flow of products (economic gains) rather than safety assurance. In 2002, the Council of the EU and the European Parliament adopted Regulation (EC) No. 178/2002, presenting the principles of General Food Law and creating the European Food Safety Authority (EFSA). This made the decisions centrally controlled. EFSA is an independent agency that provides scientific advice to member states and EU institutions. It gathers data to help anticipate risks and issues opinions on matters relating to human nutrition and health, animal welfare, plant health, and genetically modified organisms. It gives scientific evaluation to food safety issues. The EFSA gives scientific risk assessments but does not handle any of the risk management. Instead, the European institutions and the member states themselves are responsible for risk management. European Food Safety Authority (EFSA). EFSA provides scientific opinions and scientific and technical assistance, establishes surveillance procedures, promotes cooperation among food safety organisations, and plays a crucial role in risk assessment and communication. EFSA’s first 10 years of activity has achieved a positive balance: despite the dramatic changes within the EU, it has successfully adapted itself. The need for the harmonisation of food hygiene requirements led to the adoption of the hygiene package and the HACCP system (Reg. 852/2004), as well as of specific hygiene rules applicable to products of animal origin (Reg. 853/2004). The conclusions drawn are encouraging: EU food law, by adopting harmonised vertical rules and regulations common to all operators, has committed to ensuring common, high quality standards. EU authorities’ capacity to promptly and effectively react to significant food crises has led to one of the most developed systems worldwide, one that is functional for
  • 20. 20 operators and safe for consumers. Yet the need for rapid, repeated actions, is a constant challenge, which certainly cannot be considered complete. The general principles of food and feed law are outlined in the General Food Law Regulation (Articles 5 to 10). They form a horizontal framework underpinning all Union and national measures relating to food and feed. They cover all stages of the production, processing and distribution of food as well as feed produced for (or fed to) food-producing animals. General objectives of food and feed law: ➢ Guarantee a high level of protection of human life and health and the protection of consumers’ interests. Also guarantee fair practices in food trade, taking into account animal health and welfare, plant health and the environment ➢ Ensure free movement of food and feed manufactured and marketed in the Union, in accordance with the General Food Law Regulation ➢ Facilitate global trade of safe feed and safe, wholesome food by taking into account international standards and agreements when developing Union legislation, except where this might undermine the high level of consumer protection pursued by the Union. Risk analysis principle The General Food Law Regulation establishes the principle of risk analysis in relation to food and feed and establishes the structures and mechanisms for the scientific and technical evaluations, which are undertaken by the European Food Safety Authority (EFSA). Depending on the nature of the measure to be used, food law, and in particular measures relating to food safety must be underpinned by strong science. The Union has been at the forefront of the development of risk analysis principles and their subsequent international acceptance. Food law is based on the three inter-related components of risk analysis: • risk assessment • risk management
  • 21. 21 • risk communication. Risk assessment must be undertaken in an independent, objective and transparent manner based on the best available science. Risk management is the process of weighing policy alternatives in the light of results of a risk assessment and, if required, selecting the appropriate actions necessary to prevent, reduce or eliminate the risk. In the risk management phase, the decision makers need to consider a range of other information in addition to the scientific risk assessment. These include, for example: • most effective risk reduction actions depending on the part of the food supply chain where the problem occurs • feasibility of controlling a risk • socio-economic effects • environmental impact • a wide range of other factors legitimate to the matter under consideration Risk communication is the interactive exchange of information and opinion throughout the risk analysis process among risk assessors, risk managers, consumers, feed and food businesses, academics, other interested parties. Precautionary principle The precautionary principle (Article 7 of the General Food Law) refers to specific situations where: • there are reasonable grounds for concern that an unacceptable level of risk to health exists • the available supporting information and data are not sufficiently complete to enable a comprehensive risk assessment to be made. When faced with these specific circumstances, decision makers or risk managers may take measures or other actions based on the precautionary principle, while seeking more complete scientific and other data. Such measures have to comply with the principles of non- discrimination and proportionality and should be provisional until the time when more comprehensive information concerning the risk can be gathered and analysed. Transparency
  • 22. 22 Food safety and protection of consumer interests are of great concern to the general public, non-governmental organisations, professional associations, international trading partners and trade organisations. Therefore, transparency of decision-making is of paramount importance. The General Food Law Regulation provides for the mechanisms necessary to increase consumer confidence in food law: • Effective public consultations during the preparation, evaluation and revision of food and feed law • Obligation on public authorities to inform the general public, where there are reasonable grounds to suspect that a food or feed may present a risk for human or animal health. Tasks, Structure, and Operation EFSA’s main task is to ensure constant, competent, and independent technical advice and scientific support in the matter of food safety by collecting and analysing data either collected by it or brought to its attention. As specified in the Regulation “The Authority should be an independent scientific source of advice, information and risk communication in order to improve consumer confidence”. In performing its duties, the Authority must also: offer scientific advice, together with scientific and technical support on human nutrition; formulate scientific opinions on any issue related to the health and welfare of animals, and to the health of vegetables; and formulate scientific opinions on non-food and non-feed products that may be traced back to genetically modified organisms. Therefore, it is a fundamental reference for the new system, capable of supporting the preparation, definition, and implementation of food legislation, also through a coordination of roles among the competent bodies of the different Member States and the Community bodies. Article 23 of Regulation No. 178/2002 clarifies and lists the tasks of the Authority, by establishing that the latter must: (a) provide scientific and technical assistance and advice; (b) provide opinions on the subject matter; (c) search for, collect, collate, analyse, and summarise scientific and technical data in the fields within its mission; (d) contribute to collaboration amongst the different organisations operating in the fields within its mission and create a European network; and (e) identify and communicate emerging risks.
  • 23. 23 FOOD REGULATIONS IN THAILAND The laws and regulations governing the Thai food industry are confined to the scope of the Food Act B.E. 2522 (1979). The Food Act authorizes the Ministry of Public Health’s Food and Drug Administration (FDA) to implement and administer the Food Act. Under the Act, all establishments producing food for sale or importing food for sale must be licensed by the Food Bureau of the FDA. The application and granting of licenses must be in accordance with the principles, procedures or conditions prescribed in the Ministerial regulations, which are periodically elaborated, modified, and issued by the FDA’s Food Bureau. Food Act of B.E. 2522 (1979) The Food Act of B.E. 2522 (1979) remains in effect. The Act defines the word “food” as edible items and those which sustain life including: (A) Substances that can be eaten, drunk, dissolved in the mouth or induced into the body by mouth, no matter in what form, but not including medicine, psychotropic and narcotic substances. (B) Substances intended for use or to be used as ingredients in the production of food including food additives, coloring, and flavoring materials. The Food Act classifies food into four categories as listed below: 1. Specifically-controlled foods: Under this category, product registration is required. Legal provisions are established regarding standard quality, specifications, packaging and labeling requirements, as well as other aspects of good manufacturing practices. 2. Standardized foods: Foods produced under this category must adhere to quality standards as defined in the regulations. This category was created to standardize the production of locally produced food from small-scale or household industries in order to provide consumers the ability to differentiate such products by qualitative attributes and to encourage food producers on attaining hygienic quality of their products. 3. Foods required to bear standardized labels: This category is less-restrictive than the first two categories, as foods under this category pose a lower risk to consumers’
  • 24. 24 health and does not have to follow specific quality standards for manufacturing. However, products must bear standardized labels that provide consumer information. 4. General foods: Consists of raw, cooked, preserved, non-preserved, processed or non- processed foods that are not listed in the above categories. Although registrations are not required, general food products are controlled and monitored based on hygiene, safety, labelling and advertisements. The following food production categories are also subject to additional regulations. These include: quality standards for food containers, plastic containers, and feeding bottles. Prohibited Food and Substances 1. Substances prohibited in foods: • Calcium iodate or potassium iodate except to be used to adjust the nutrition that relates to iodine deficiency as approved by the Thai Food and Drug Administration. • Nitrofurazone • Formaldehyde, formaldehyde solution and paraformaldehyde • Methyl alcohol or methanol except for use as processing aids for export purpose. 2. Foods prohibited to be manufactured, imported, or sold: (i) Brominated vegetable oil (ii) Salicylic acid (iii) Boric acid (iv) Borax (v) Potassium chlorate (vi) Coumarin, or 1,2- benzopyrone, or 5,6-benzo- alpha-pyrone, or cis-o- coumaric acid anhydride, or o-hydroxycinnamic acid, lactone (vii) Dihydrocoumarin, or benzodihydropyrone, or 3,4- dihydrocoumarin, or hydrocoumarin (viii) Diethylene glycol, or dihydroxydiethyl ether, or diglycol, or 2,2’-oxybis-
  • 25. 25 ethanol, or 2,2’- oxydiethanol (ix) Dulcin or 4- ethoxyphenylurea or para- phenetolcarbamide (x) AF-2 or 2-(2-furyl)-3-(5- nitro-2-furyl) acrylamide or furylfuramide (xi) Potassium bromate (xii) Formaldehyde, formaldehyde solution and paraformaldehyde (xiii) Melamine and its analogues, specifically cyanuric acid (xiv) Foods in which substance no. 1-13 is used as ingredient. (xv) Genetically modified foods containing Cry9C DNA Sequence and foods containing such genetically modified food. (xvi) Ready-to-eat gelatin and jelly, containing glucomannan or konjac flour packed in small containers with a diameter or diagonal width no larger than 4.5 cm. (xvii) All kinds of puffer fish and foods containing puffer fish meat as an ingredient. (xviii) Food containing objects other than food packed inside food packages, except for the purposes of food quality or standard preservation such as desiccator, oxygen absorber, etc., and in separate packages, seasonings or consuming accessories (such as plastic spoons, chopsticks, measuring spoons, etc.) Objects other than food may be packed with food packages, but only if they do not pose a risk to humans or mislead consumers that those objects can be eaten. (xix) Partially hydrogenated oils and foods contain partially hydrogenated oils 3. Food prohibited to be imported or sold:
  • 26. 26 Foods with expiration dates or suitable periods of consumption, which have lapsed as stated in the label: • Infant food and food of continuous formula for infants and children. • Supplementary food for infants and children. • Modified food for infants and modified milk of follow-up formula for infants and children • Cultured milk • Cow’s milk that has been pasteurized, for example, pasteurized fresh milk, recombined pasteurized milk, flavored pasteurized milk and pasteurized milk products, etc. • Food with special objectives. Regulatory Procedures While some of the following information does not specifically apply to U.S. exporters, the following will be levied upon importers of U.S. products. The principles of regulatory procedures for food involve the following aspects. • Pre-marketing Control Activities at this stage are the responsibility of the Food Bureau in the Thai FDA. a) Establishing food standards and manufacturing requirements: Food manufacturing standards and practices must meet the minimum acceptable requirements as established by the Subcommittee on Food Standards and Local Manufacturing Requirements. b) Issuance of Food manufacturing licensing. c) Issuance of Food Import license. d) Food product registration. e) Food labeling: Imported food products, which are categorized as specifically- controlled foods, standardized foods, and foods that are required to display labels
  • 27. 27 according to the specific requisites of each category. Details on the labeling requirements are provided in Section 2. f) Nutrition labeling: Nutrition labeling is required for some products. g) Good Manufacturing Practices (GMP) h) Under Ministerial Notification No. 193, B.E. 2543 (2000), Method of Food Manufacturing and Equipment for Manufacturing Food and Food Storage, Thailand requires domestic manufacturers and foreign suppliers for 61 types of products must adhere to GMP. These include: • Infant food and follow-up formula food for infants and children • Supplementary food for infants and children • Modified milk for infants and follow-up formula modified milk for infants and children • Ice • Drinking water in sealed containers • Beverages in sealed containers • Food in sealed containers • Cow’s milk • Cultured milk • Ice cream • Flavored milk • Other milk products • Food additives • Food colors • Food enhancers • Sodium cyclamate and food containing sodium cyclamate • Food for weight control • Tea • Coffee • Fish sauce • Remaining solution from Mono Sodium Glutamate production • Natural mineral water
  • 28. 28 • Vinegar • Fat and oil • Peanut oil • Cream • Butter oil • Butter • Cheese • Ghee • Margarine • Semi-processed food • Some particular kinds of sauces • Palm oil • Coconut oil • Electrolyte drinks • Soybean milk in sealed containers (except manufacturers which are not recognized as having a factory conforming to the Factory Laws) • Chocolate • Jam, jelly, marmalade in sealed containers • Food for special purposes • Alkaline-preserved eggs • Royal jelly and royal jelly products • Products from the hydrolysis or fermentation of soybean protein • Honey (except manufacturers which are not recognized as having a factory conforming to the Factory Laws) • Fortified rice with vitamins • Husked rice flour • Brine for cooking • Sauce in sealed containers • Bread • Gum and candy • Processed gelatin and jelly desserts • Foods packed together with material intended for quality control purposes • Garlic products • Some meat products
  • 29. 29 • Flavoring agents • Foods containing aloe vera • Frozen foods • A prepared set of ready to cook food, which separated ingredients • Bakery products • Meat products as per the Ministry of Public Health no. 243 Re: Meat products • Noodle made from rice flour Food Additives Regulations Food additives are substances which normally are not used as food or essential ingredients of food, whether or not such substances have food value, but which are added for the benefits of production technology, packing, storage or improve the quality or standards or the nature of food. They also include substances mixed with food for the purposes stated earlier. Food additives are specified as specifically-controlled food of which the quality or standards are defined. Use of food additives must follow the set objectives for the specified kinds of food and maximum permissible quantity, food additive functional classes categorized according to CODEX as listed below: • Acid • Acidity regulator • Anticaking agent • Antifoaming agent • Antioxidant • Bulking agent • Color • Color retention agent • Emulsifier • Emulsifying salt • Firming agent • Flavor enhancer • Flour treatment agent • Foaming agent • Gelling agent • Glazing agent • Humectant • Preservative • Propellant • Raising agent • Stabilizer • Sweetener • Thickener
  • 30. 30 Use of food additives for purposes other than stated must be petitioned for the FDA’s approval. Any food additives not listed below, but are available under CODEX (GSFA) are generally acceptable by the Thai FDA. Pesticides and Other Contaminants Food containing pesticide residues and contaminants are enforced by the Ministry of Public Health’s Food and Drug Administration (FDA). Thai FDA establishes regulations and imposes maximum residue limits (MRLs) based on the MRL standards established by the National Bureau of Agricultural Commodity & Food Standards (NBACFS). In addition, the Department of Agriculture (DOA) in the Ministry of Agriculture and Cooperatives (MOAC) controls the use of agricultural chemicals. Food Containing Pesticide Residues The tolerance levels for residues allowed in foodstuffs are defined as Extraneous Residue Limits (ERL) and Maximum Residue Limits (MRL). However, a zero tolerance level is set for toxic substances in agriculture which are officially prohibited under the Notification of Ministry of Agriculture and Cooperatives, except for the established Extraneous Maximum Residue Limit. • Food Containing Contaminants According to Ministerial Notification No. 98 of B.E. 2529 (1986) and Ministerial Notification No. 273 of B.E. 2546 (2003), food shall not contain contaminants with more than the following specifications.
  • 31. 31 The Thai FDA requires that all food products must be free of the following chemicals and their metabolites as stipulated in Ministry of Public Health’s Notification No. 299 B.E. 2549 (2006) Re: Prescribed Standards for Some Chemical Contaminations in Foods (2nd Edition). A list of chemicals under this regulation include the following: • Chloramphenicol and its salts • Nitrofurazone and its salts • Nitrofurantoin and its salts • Furazolidone and its salts • Furaltadone and its salts • Malachite green and its salts Food Pathogens Control Measures in Food Products Importers of 38 types of products listed under the Ministry of Public Health’s Notification No. 364 Re: Food Standards as Regards Pathogens B.E. 2556 (2013) must present a lab analysis report during the food product registration process to ensure that imported products are pathogen free or their presence does not exceed maximum specified limits stated in the notification. The Thai FDA accepts lab analyses reports issued by government laboratories from the country of origin, government laboratories in Thailand, private laboratories accredited by the Thai government or laboratories accredited by international accreditation agencies. • Yeast and Mould Level in Foods In September 2010, the Thai FDA revised and set new tolerance levels for yeast and mold in six food categories: beverages in sealed containers, coffee, tea, chocolate, weight control foods, and electrolytes. The background of the notification and the established tolerance levels for yeast and mold in foods are available in GAIN report TH0144.
  • 32. 32 Packaging and Container Regulations The Thai FDA requires that all packaging and containers of food must comply with Ministerial Notification No. 92, B.E. 2528 (1985) and No. 295, B.E. 2548 (2005). The guidelines on packaging and containers are as follows: (A) A container must: • Be clean • Not emit any heavy metal or other substances that would contaminate food in a volume to be harmful to health • Free of germ contamination • Emit no food contaminating color. (B) Containers which are made from ceramic or enameled metal must conform to subsection (A) and meet lead and cadmium standards as described in Schedule 2 of the Ministerial Notification No. 92 (B.E. 2528) Re: Prescription of Quality or Standard for Food Containers, Use of Food Containers, and Prohibition of Use of Things as Food Containers. (C) Containers which are made of plastic must conform to not only the quality or standard in subsection (A), but also the quality or standard in Schedule 1 of the Ministerial Notification No. 92 (B.E. 2528) Re: Prescription of Quality or Standard for Food Containers, Use of Food Containers, and Prohibition of Use of Things as Food Containers. (D) Plastics in the form of sheets or bags which are used as food containers must not be made from used plastic and must not have coloring except for: a) laminate plastic, only the layer that’s not in direct contact with the food; and b) plastic which is used for packing shelled fruits. (E) Plastic containers of milk, milk products, and other products similar to milk products (such as soybean milk and coconut milk) must be made from Polyethylene, Ethylene, 1-Alkene Copolymerized resin, Polypropylene, Polystyrene or Polyethyleneterephthalate. (F) Use of containers that have previously been used to pack or wrap fertilizers, hazardous substances or any substance likely to be harmful to humans is prohibited.
  • 33. 33 (G) Use of containers that have been made to pack other products, which are not food, that bear a design or statement that may mislead to the actual contents of a particular food is prohibited. Ministerial Notification No. 310, B.E. 2551 (2008) lists additional measures prohibiting objects other than food to be packed into food packaging (See GAIN report TH8082). The major revision of this notification is as follows: • Objects other than food shall not be packed inside food packages, except for the purposes of food quality or standard preservation such as desiccators, oxygen absorber, etc., in separate packages; seasonings or consuming accessories (such as plastic spoon, chopsticks, measuring spoon, etc.). • Objects other than food may be packed with the food packages, but only if they do not pose a risk to humans or mislead consumers that those objects can be eaten. Labeling Requirements • Standard Labeling Imported food products or domestic food products are required to display labels. For imported foods, a Thai label must be applied where needed prior to entry and be affixed to every single item of the food product prior to marketing. Failure to apply the label before entry will lead to product seizure by the Thai FDA. The Thai FDA only requires pre-approved labels for specifically-controlled foods. For other foods, the food manufacturers or food importers are responsible to prepare a product label that complies with the Ministerial Notification No. 367 B.E. 2557 Re: Food Labeling of Prepackaged Food, which is the new food labeling law for all prepackaged foods that became effective on December 3, 2014. • Labelling of Modified Milk for Infants In order to promote the importance of maternal milk and the benefits received from drinking maternal milk for both infants and small children, the Thai FDA requires producers and importers of modified milk and modified milk of uniform formula for infant and children to display the following statements on the label: ➢ The best food for infants is maternal milk owing to its full nutritional content.
  • 34. 34 ➢ Modified milk for infants should be recommended by a physician, nurse or nutritionist. ➢ Incorrect preparation or mixture will be hazardous for infants. • Labeling of Cow’s Milk Exporters must follow new labeling requirements stated under the Ministry of Public Health Notification No. 350 Re: Cow’s Milk that governs the display and declaration statements of certain types of cow’s milk on food labels. However, for other general labeling requirements, the exporter can refer to the Ministry of Public Health Notification No. 194 Re: Food Labels. • The Use of the Term “Premium” on Food Labels The Thai Food and Drug Administration (FDA) requires food manufacturers or importers of products which use the term “premium” on their products’ labels to meet a certain set of quality standards and specific characteristics as stipulated under Ministry of Public Health Notification No. 365 Re: Expression of the term “Premium” on food labels. To export products that display the term “premium” on food labels, an exporter must submit the required documents to the Thai Food and Drug Administration to prove that their product meets the criteria listed in the notification. (See GAIN report TH3099). Nutrition Labelling The regulations on nutrition labelling are based on the Ministerial Notification No. 182 of B.E. 2541 (1998) and No. 219 of B.E. 2544 (2001). Nutritional labeling is mandatory for the following types of food: • Foods making a specific nutritional claim. • Foods that make use of nutritional values in sales promotions. • Foods that specifically target a group of consumers (e.g. students, executives, elderly people, etc.) • Other foods which may be specified by the Thai FDA, including potato chips, corn chips, extruded snack foods, biscuits/crackers, assorted wafers as per Ministerial Notification No. 305. Effective as of December 18, 2007, the Thai FDA requires
  • 35. 35 nutrition labeling for five groups of processed foods by displaying information that states “Should take less and exercise for a better health.” Details of the notification are discussed in GAIN Report TH7136. • Exemptions of these nutrition labeling regulations (as defined in Ministerial Notification No. 182) are infant foods, supplementary foods for infants and children, and other types of food for which labeling requirements have been otherwise regulated; food not directly sold to consumers; and food packed in small containers which will be repacked and sold in a larger container. Nutrition labeling must be presented in Thai and a foreign language is optional. The standard U.S. nutrition fact panel is not acceptable as Thai Recommended Daily Intakes may not be identical to the United States. In addition, differences may exist in serving size and reference amount. In Thailand, the Food Act of B.E.2522 (1979) is the main law aimed at protecting and preventing consumers from health hazards occurring from consumption of food. The Act prohibits unsafe food from being produced, imported and distributed in Thailand. The Act divides unsafe food into four categories based on the causes that make the food unsafe to consumers: (1) impure food, (2) adulterated food, (3) substandard food and (4) other foods which prescribed by the minister. Other areas covered by the Act include control of packaging and labelling as well as restrictions on advertisement. The Food and Drug Administration under Ministry of Public Health is responsible for the execution of the Act. The Act empowers the Ministry of Public Health to promulgate ministerial regulations, to appoint the Food Committee and competent officers, and to set up other activities in order to carry out the provisions of the Act. Along with the Food Act of B.E. 2522 (1979). The ministerial regulations describe the procedures for applications of manufacturing licenses, i mport licenses, and registration including the rates of fees, the identification card of the
  • 36. 36 competent officers and the labelling of food products for exports. The Food Act B.E. 2522 (1979) classifies foods into three main categories as follows: • Specially Controlled Foods—Registrations are required for foods in this category. Legal provisions are related to food standard quality, specifications, packaging, and labelling requirements, as well as other aspects of good manufacturing practices. The Food Committee may make recommendations to the Minister of Public Health specifying specially controlled foods. • Standardized Foods—Standard foods do not require registration but their quality and labelling have to meet the standard requirements as specified in the Notification of the Ministry of Public Health. • Other Foods—Foods, raw or cooked, preserved or non-preserved, processed or non- processed, if not listed under category 1 or 2 will be considered as general foods. Although registrations are not required, general food products are controlled and monitored with regard to hygiene, safety, labelling and advertisement. Foods in this category may be subdivided into (a) foods that must bear standard labels and (b) other general foods. The control measures for each category of foods differ; with measures for “Specially Controlled Foods” being strictly controlled. Before producing or importing such foods, the application for product registration is required. For standardized foods, the application for such permission is not required, but they must be produced up to the prescribed quality or standard. For labelled foods, however, the main objective is to control the labelling in order to avoid misleading or cheating of consumers. The Food and Drug Administration (FDA) of the Ministry of Public Health and the Provincial Offices of Public Health is responsible for the enforcement of the Food Act as well as legal food control operations with the support of food analytical services of the Department of Medical Sciences, Ministry of Public Health. The FDA also has the responsibility to ensure that the development of food safety control measures corresponds with international standards.
  • 37. 37 Table: Acts in various areas of food safety in Thailand
  • 38. 38 REVIEW OF PREVIOUS STUDY Modern food safety policy came into being at the turn of the twentieth century in response to scandals in the meat packing and food processing industries (Sinclair 1906). A second generation of policy is emerging now, also driven by scandals and crises of trust, including the early 1990s’ E. coli outbreak in the United States and the BSE scandal of the late 1990s in the UK. Behind the current crises lie economic and technological transformations in both food and the food supply system. Institutions are rushing to catch up with the implications these changes have for public health risks. The first generation of food safety law was characterized by command and control forms of safety regulation. Policy was nationally focused and relied on early twentieth-century industrial management practices such as continuous line inspection, visual product inspection, and detailed specification of approved hygiene practices. At the heart of this second generation of food safety policy is an emerging global consensus on the need for a preventive, public health focused policy that fosters integrated management of foodborne hazards from farm-to-fork. This consensus calls for use of modern science-based risk management instruments that enhances efficiency by more accurately targeting public actions and by allowing firms flexibility in how they achieve public health goals rather than relying on narrowly prescriptive command and control policies. While the broad vision for this second generation of policy is clear, much of the detail has yet to be worked out. Economists have a significant role to play in this process. Indian food regulations under the Ministry of Food Processing Industries was set up in July, 1988 to give an impetus to development of Food Processing Sector in the Country. The Ministry is concerned with formulation and implementation of the policies and plans for the food processing industries within the overall national priority and objectives. The Ministry has taken a number of initiatives to promote investment in food processing sector. The Food safety and standards (FSS) rules required under the Food Safety and Standards Act, 2006 (FSSA) are being framed by the 23-member Food Safety and Standards Authority (FSS Authority). Under the act the FSS authority would function as an apex body to implement the rules. The objective of FSSA is to consolidate the laws relating to food, establish FSS Authority for laying down science-based standards for articles of food, regulate the manufacture, storage, distribution, sale and import of food products, and ensure availability of safe and wholesome food for human consumption.
  • 39. 39 The Indian food processing industry is regulated by several laws which govern the aspects of sanitation, licensing and other necessary permits that are required to start up and run a food business. The legislation that dealt with food safety in India was the Prevention of Food Adulteration Act, 1954 (hereinafter referred to as "PFA"). The PFA had been in place for over five decades and there was a need for change due to varied reasons which include the changing requirements of our food industry. (Source: Indian Laws Governing the Food Industry in India – Revisited Vinay Vaish) The first hand literature is provided by the existing piece of legislature, the Food Safety and Standards Act, 2006. This act has consolidated the laws relating to food and to establish the Food Safety and Standards. This act has triggered the new era in food legislations. The discussion, food safety summits, commentaries, conference proceedings, workshops, and debates on while formulation if this act had helped to understand the approach, methodology and mechanism of it. The previous legislations, cases had further helped to understand the key issues before the government to bring the new one. The rules passed under the FSS Act, 2006 also helps to understand the administrative and procedural mechanism for regulations. Apart from the same, the literature available on World Health Origination webpage is very important as it give the global standards and developments. The guidelines provided by various nations are also very helpful. From 1958 to the mid-1990s, the focus of European food law was to reduce barriers to creating an integrated internal market for foods (van der Meulen and van der Velde 2008; Alemanno 2006). Uncertainty about product content, not food safety was viewed as the major barrier to a single food market. The BSE crisis and other foodborne illness crises of the mid- to late 1990s changed this perspective (van der Meulen and van der Velde 2008). The nature of BSE—a fatal, neurodegenerative disease related to scrapie in sheep—and the way that crisis was handled had a significant impact on subsequent legislative reform. At the time it was identified, the British government maintained that BSE, like scrapie, was not transmissible to other species (Prusiner 1991). By the late 1980s, transmission among cattle was traced to the presence of animal offal and bone meal in cattle feed. Britain banned this practice in1988 and the EU banned importation of beef offal from Britain. Scientific evidence began to mount that BSE was being transmitted to humans (Krapohl 2008). Britain continued to maintain that this was not the case until March 1996 (van der Meulen and van der Velde 2008). The European
  • 40. 40 Commission (EC) banned export of cattle and cattle products from the UK several days later. A 1996 EU Committee of Inquiry found that the structure of EU food safety governance that allowed domination of decisions by a single member state, politicization of science, and lack of transparency contributed to the inability of the EU to respond to the crisis quickly (European Parliament 1997). Subsequent European food safety crises contributed to pressure for immediate action (van der Meulen and van der Velde 2008; Holland and Pope 2004). Recommendations for structural change followed quickly in the form of a Green Paper in April 1997 and a White Paper on food safety in January 2000 (EC 1997, EC 2000). The White Paper laid out a roadmap for EU legislative reform guided by five central principles: clearly defined food safety responsibilities for all actors; traceability of food, feeds, and food ingredients to their sources; risk analysis as the framework for science-based policy; transparency and separation of scientific analysis from risk management; and use of the precautionary principle to guide risk management (Halkier and Holmes 2006). To reduce the role of economic interests in food safety policy decisions, responsibility for risk assessment and scientific advice would lie with a new European Food (Safety) Authority and responsibility for risk management would lie with the European Commission. A set of 84 legislative and policy initiatives was outlined. The goal was to make European food law more coherent and comprehensive and to strengthen enforcement and make it more consistent across countries (van der Meulen and van der Velde 2008). Several studies have examined the European food safety policy reform movement of the 1990s from the perspectives of law, political science, public administration, and sociology, but few from an economic perspective (Halkier and Holm 2006; Ansell and Vogel 2006; Alemanno 2006; Vos and Wendler 2006). The most fundamental change in the E.U. system has been recognition of the central role that food safety and consumer protection play in integration of the European food market and with this adoption of risk analysis as a structure to shape and bring transparency to conflicts between the goals of integration and maintenance of diverse food cultures and other local and national values (Alemanno 2006). The EFSA has responsibility for conducting scientific assessment of new food safety policy, but national competent authorities do as well. While both the EC and national authorities are required to take account of EFSA scientific assessment, they are not bound by it. While many food safety issues are now addressed by EU-wide regulation, not all are and in the absence of EU-wide regulation, food is deemed safe and marketable across the EU if it meets the national safety
  • 41. 41 requirements. As Alemanno points out “a claim by a domestic food authority that a certain good is safe or unsafe is likely to involve not only an assertion about science, but also about the willingness of this country to bear or not bear the level of risk considered acceptable in order to continue or reject a certain local tradition” (Alemanno 2006: 254). Of course, national decisions may also be driven by a desire to protect local economic interests. In the case of conflicting scientific opinion, it will be up to the European Court to determine the balance between local, national and Europe-wide interests. It remains to be seen what balance is ultimately worked out between national and EU concerns. Elements of National Food Safety Policy in UK • farm-to-table food safety authority lies with Food Standards Agency • GFL food and feed law implemented by FSA • emphasis on public health and consumers • risk management lies with an agency • risk assessment with agency committees Source: UK House of Commons 1999; HM Treasury 2003; Slorach 2008; interview with Derrick Jones, chief economist FSA, 2009 Globalization has brought many benefits to consumers, including more varied and nutritious food supplies throughout the year, but it has also complicated management of both infectious and noninfectious foodborne hazards. In developing countries, globalization has helped increase incomes. Globalization has also fostered industrialization and urbanization, which can strain capacity for adequate sanitation and safe food handling (Kaferstein et al. 1997; WHO 2002). It can also lead to more rapid spread of foodborne disease. Poor sanitation in developing countries can result in contamination of food exports to developed countries, as happened in the 1996 Cyclosporiasis outbreak in the United States associated with Guatemalan raspberries (Katz et al. 1999; Calvin et al. 2003). But trade may also spread foodborne pathogens. between developed countries, as in the spread of BSE from Britain to Japan in 2001, or from developed to developing countries (McCluskey et al. 2005). Food safety policy has a long history of using risk analysis to guide public decisions. A study by U.S. Food and Drug Administration (FDA) toxicologists in the mid-1950s introduced safety
  • 42. 42 factors to establish acceptable daily intake of food additives on the basis of acute toxicity, an approach still applied today (Lehman and Fitzhugh 1954). Broader government commitments to greater economic integration have had and will continue to have significant impact on food safety policy. The General Agreement on Trade and Tariffs (GATT), negotiated in the wake of World War II, has and continues to provide the cent legal structure for international trade. Its goal is to liberalize trade through successive rounds of negotiation guided by the principals of equal treatment for trading partners, transformation of nontariff barriers to tariffs, and negotiation to reduce tariffs over time (GATT 1947, Art. I). GATT recognizes limited exceptions to its general requirements. One of the most important is the exception for actions required to protect health (GATT 1947, Art. XX).
  • 43. 43 RESULTS & DISCUSSIONS Every nation needs an effective food legislation and food control service to promote a safe, honestly presented food supply, and to protect consumers from contaminated, adulterated, and spoiled foods. Generally, the food law is divided into two parts: a basic food act and regulations. The Act itself sets out broad principles, while regulations contain detailed provisions. The principles or general provisions to be included in food law are primarily: basic purposes and scope, definitions of basic concepts, inspection, enforcement, biological and chemical contaminants, packaging and labelling, and procedures for the preparation and amendment of the regulations for implementation of the law. Food law is based on scientific studies. Harmonization of Food Law on the international level is a worldwide trend from the late twentieth century. The introduction of integrated food law provides the much required ‘one law-one regulator’ platform for raising the food safety standards of India to match global standards. Its speedy and effective implementation is quickly warranted to put India onto the global food map. This would require an enabling implementation environment focused on creation of transparency, awareness creation, capacity building, product traceability, developing right infrastructure and extensive R&D capacity so as to match the dynamically changing requirements of food safety and standards. Over a period of time the developed importing countries have been making changes in their regulatory policies which are consumer centric. The comparison of the regulatory regimes of the selected economies shows that the regulations of EU have been stringent since 2002 with the adoption of traceability and precautionary principles. In Thailand, there are a number of variations in the rules and regulations governing specific categories and types of food, the general guidance by setting out the general penalties and repercussions in regard to noncompliance in the areas are as follows: Compliance area Penalty Product registration Subject to imprisonment of not more than 2 years or a fine of not more than THB 20 000, or both Variations in product registration Subject to imprisonment of not more than 1 year or a fine of not more than THB 10 000, or both Manufacturing Subject to imprisonment of not more than 3 years and a fine of not more than THB 30 000, or both Advertising Subject to imprisonment of not more than 3 years and a fine of not more than THB 30 000, or both Labelling Subject to a fine of not more than THB 30 000
  • 44. 44 CONCLUSION Every nation needs an effective food legislation and food control service to promote a safe, honestly presented food supply, and to protect consumers from contaminated, adulterated, and spoiled foods. Harmonization of Food Law on the international level is a worldwide trend from the late twentieth century. The laws discussed of the select economies are essentially dynamic in nature and have evolved from over time in the interest of consumer. The experience of each of the select nations show that in totality their different levels of strictness is likely to entail different set of issues for the exporters. Organizations such as the Bureau of Indian Standards and the Regulatory body- FSSAI, in principle endeavour to include various groups of stakeholders in the standards setting process. Also, the inherent structure of technical committees, their composition at national and international level gives us a glimpse into the different actors shaping this process. India’s pace of development is challenged by restrictions on the importation of food into developed countries on the grounds of food safety. The country’s food safety regime needs more effective implementation to meet best practice internationally. Alignment of India’s food standards with international norms of food safety will both increase and stimulate domestic production and economic development, while protecting consumers at home – and widen the overseas consumption base. Till 1990s the policy emphasis was on free flow of products rather than safety measures. With the onset of certain epidemic instances lead to rethinking on the food safety regulations. EFSA was constituted in 2002 with task providing scientific advises, including risk management, operation of the Rapid Alert System. Quick dissemination of information and networking of national agencies. The national food safety legislations within EU were harmonized with an emphasis on the following areas so as to cover the entire food chain with respect to the food policy. A comprehensive integrated approach was followed which included stages like feed production, primary production, processing storage, transportation and retail stores, to clearly attribute primarily compliance responsibility to industry produces and supplier, strengthening of enforcement at all borders, Introduction of precautionary principle which meant that there could be new regulations put even if there was an imminent danger perceived, empowerment to take rapid , effective safeguard measures to deviance, like the RASFF, dissemination of information regarding food safety policy information to consumers, unification of food safety across EU and strengthening of National Surveillance and control system, to evaluate the
  • 45. 45 efficacy of law enforcing agency, taking into account the best practices like the codex, introduction of concept of traceability through record keeping of the ingredients through proper maintenance of records, risk analysis was made the foundation of food safety system, building a robust and integrated data base on issues relating to food safety. Thai food regulations have evolved for over 100 years to improve the quality and safety of food products. Thai nutrition label policy follows the international Codex Alimentarius guidelines. A good impact on dietary behaviour, and eventually on health and nutrition, remains the elusive goal. Thai food label regulation has changed in parallel with social change and economic development for the past century, while the country underwent a transition from a traditional subsistence agricultural society to a modern manufacturing middle income state. The evolution of the Thai food industry and rules that govern domestic and international trade have interacted with economic development in prosperous ways creating lots of export opportunities to various destination round the globe.
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