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TRANSCRIPT
Prabodh Halde
Convener Regulatory Committee SEA India
Head Regulatory Marico ltd.
Changing Food Regulations in India- The
Impact on Oil Industry
Malaysian Palm Oil Council
What we will cover
Indian Food & Oil Industry
Market Trends
Regulatory requirements
Impact on Food Business Operators (FBOs)
Way forward
•Indian Food & Oil Industry
3
Indian Economy
Today India is one of the biggest agro based country with strong
economical growth, with a $ 800 billion GDP, growing at 6% annually (7% in 20012-13), is the world's 12th largest and one of its fastest growing economies
Though it is number one in Agricultural production, our Processing rates are far below compared to other developed countries.
Increasing middle class segment gives opportunity to food processing
sector and thus it is called as rising sector.
New FSSAI act has also provided huge opportunity in various sectors including Nutraceutical and functional food
4
M Dr. A.P.J Abdul Kalam
Hon’ble Ex. President INDIA 2020 a Vision for the new Millenium ( Chapter 4 Food, Agriculture &
Processing )
India At A Glance
India will be world power in Food & Agriculture by 2020
5
Indian Vegetable Oil Industry
India has shown steady growth of 5% /yr in demand of edible oils over last 13 years.
Per capita consumption : 13.3kg Vs 24 Kg of world’s average.
In respect of volume Palm,Soya bean Oil and Mustard are three largest oils consumed in India Palm -46% Soyoil – 16% Mustard – 14%
Imports are steadily increasing from 3% in year 1992 to 63% in year 2013-14.
6 Source: SEA and ICRA Analysis
Indian Oil Industry The oil seed productivity in India is low at 950 to 1000 kg per
hector ( 1/3 rd of world’s average)
The Production of oil seeds is stagnated at around 27 Million MT/yr and edible oil demand is increasing by 0.8 to 0.9 Million MT per year.
During 2012-13 – India has imported 10.38 Million MT of edible oils ( Refined and Crude) 78% Palm ( Refined/Crude) and 10% of Soy & Sun
7 Source: SEA and ICRA Analysis
8
0
10
20
30
40
50
60
70
80
90
100
Qty
Edible oil status
Domestic Veg. Oil Availability
Import of Edible Oil
Self Sufficiency (%)
Source: SEA and ICRA Analysis
Indian Oil Industry
•Regulatory Scenario
9
Food Legislation – Milestones in India
1899 : States’ / Provinces’ own food laws with difference in standards for the same commodity -- Conflicts in inter provincial trade.
1943 : Central Advisory Board for Central Legislation
1954 : Central Legislation – Prevention of Food Adulteration Act, 1954. Rules and Standards framed under the Act 1955.
2006: FOOD SAFETY & STANDARDS ACT – 2006
2011 : FSS Rules and Regulations 2011
2012 – FSS Import Regulations
Present Food Regulatory/Certification
System
FOOD LAWS (INDIA)
MANDATORY
VOLUNTARY
COMPULSORY AGMARK/BIS
FSSAI/LM
BIS/AGMARK
FSMS/HACCP
PH:PIM 12
DEFINITION OF FOOD UNDER FSSA ACT, 2006
Food means any substance, whether processed, partially
processed or unprocessed, which is intended for human
consumption and includes primary food to the extent defined in
clause (zx), genetically modified or engineered food or food
containing such ingredients, infant food, packaged drinking water,
alcoholic drink, chewing gum, and any substance, including water
used into the food during its manufacture, preparation or treatment
but does not include any animal feed, live animals unless they are
prepared or processed for placing on the market for human
consumption, plants prior to harvesting, drugs and medicinal
products, cosmetics, narcotic or psychotropic substances:
12
PH:PIM 13
FSSA, 2006
Food Safety and Standards Bill piloted by MOFPI, passed by parliament in Monsoon
session and approved by President in September, 2006
FSSAI has repealed the following Regulations :
FSSAI The Prevention
of Food Adulteration
Act, 1954(37 of 1954).
The Fruit Products Order,
1955.
The Meat Food Products Order,
1973,
The Edible Oils Packaging
(Regulation) Order, 1998.
The Vegetable Oil Products
(Control) Order, 1947.
The Milk and Milk Products Order, 1992.
The Solvent Extracted Oil, De oiled Meal, and
Edible Flour (Control) Order,
1967
Any other order issued under the
Essential Commodities Act, 1955 (10 of 1955). relating to
food.,
Legislative Frame
FSSAI 2006
FSS RULES
2011
FSS
REGULATION 2011
FSS
Import Regulation
2011
PH:PIM
Objectives of FSSA
W
• To consolidate the laws relating to food
• To establish food safety and standards authority of India for laying down science based standards for articles of food.
H • To regulate the manufacture, storage, distribution, sale
and import of food products
Y • To ensure availability of safe and wholesome food for
human consumption
PH:PIM 18
Salient features Defines the concept of “substandard”
and “unsafe food”;
emphasizes on the need on risk
assessment; not trade restrictive
Provisions relating to functional and
novel food
Prescribes graded penalties for
offenses/violations
Improvement notices
PH:PIM 19
Regulatory Mechanism
Central Advisory Committee
Scientific Panels
Scientific Committees
Food Saftey Authority and the
State Foods Safety Machinery
PH:PIM
Where is the emphasis :
Minimum Effective
Legislation
Legislation should not
restrict competition
Include non regulatory measures
Innovations for Consumer Choice &
Health
Science base legislation
Risk Analysis
Evidential Analysis
Enforcement to enablement
Graded penalties
Risk
Science base standards Risk base system
Risk = Hazard X Exposure
PH:PIM
Critical Shifts – PFA to FSSA
Adulteration Safety
Several Authorities Single Authority
Prescriptive Standards General Standards
Inspection /Control Monitoring & Surveillance
•Impact on Oil Industry
23
General Impact
All Big manufacturing facilities will need to be licensed by Central Licensing Authority FSSAI
All importers need to take import license from FSSAI.
Small players /warehouses/distributors will need to obtain a valid license/Registration from State Licensing Authority
New Products and Proprietary foods need Product approval
All the licensed establishments will be subject to periodical inspections and food safety audits by respective licensing authorities
FSMS Plan and Food Recall process
General Impact
Reduction in court cases by adjudication process
Agmark & Legal Metrology will continue as it is.
New Import regulations.
New food categorization systems.
Food Additive approval system.
New section of food categorization : Section 22 Functional food and Nutraceuticals More scope for product innovation
New documents of label claims & Claim substantiations.
Licensing and Registration of Food Business
Central Licensing
Authority
State Licensing
Authority Registering
Authority
Designated Officer
appointed by the Chief
Executive Officer of the
Food Authority of India
in his capacity of Food
Safety Commissioner
Food Safety Officer or
any official in Panchayats, Municipal
Corporation or any other local body in an area, notified as such
by the State Food Safety Commissioner
for the purpose of registration
Designated Officers
appointed under
Section 36(1) of the
Act by the Food Safety
Commissioner of a
State or UT for the
purpose of licensing
and monitoring.
Schedule 4 Requirements : GMP/GHP
1. Location and Surrounding
2. Layout and Design of Food Establishment Premises
3. Equipment
4. Facilities
5. Food Operations and Control
6. Management and Supervision
7. Food testing Facilities
8. Audit, documentation and Records
9. Sanitation and Maintenance of Establishment Premises
10. Personal Hygiene
11. Product Information and Consumer Awareness
12. Training
Food Categorization
Food
Standard Food Proprietary
Food
Novel Food/organic food/GM food
Food for specific
nutrition
Health Supplement
FSDU
Pre Market Approval required
Restricted category
Product Approval System
•Form 1D
•If already approved by FSSAI
•Partly approval by TC
•1 B
•With botinicals/animal parts
•NOC then approval
•1A
•Direct Approval
•Simple and easy
•1 C
•Novel ingredients
•New products
Safety not
sufficient
Safety proven as
per FSS /EU/USFDA
/NZ
Approved by FSSAI/CODE
X
Safety Proven
20 Months
3 Months
Application received by FSSAI
Internal expert
Scientific panel
Scientific committee
Food Authority
Legal Ministry
Draft Notificatio
n
Final Notificatio
n
Risk Base Approach R
egul
atio
ns
Safety Low
High
High
Novel foods FSDU New Foods
Traditional Foods Regular foods Common Foods
2%
98%
18 Main Categories
1 – 16 E.g. Fats & Oils,
Cereals & pulses, etc.
17 - Products not covered into category 1-16
99 - Substances added to food which are ‘not for direct consumption as food’ e.g. vitamins, minerals, additives etc
Food Categorization Structure
1.0 Dairy products and analogues 2.0 Fats and oils, and fat emulsions
3.0 Edible ices, including sorbet 4.0 Fruits and vegetables
5.0 Confectionery
6.0 Cereals and cereal products 7.0 Bakery products
8.0 Meat and meat products 9.0 Fish and fish products
10.0 Eggs and egg products 11.0 Sweeteners
12.0 Salts, spices, soups, sauces, salads and protein products
13.0 Foodstuffs intended for particular nutritional uses
14.0 Beverages 15.0 Ready-to-eat Savories
16.0 Prepared Foods 17.0 Others
18 Food Categories
99.0 Substances added to food
Every container in which vanaspati, margarine, bakery shortening,
Blended edible vegetable oils, mixed fat spread and refined
vegetable oil is packed shall bear;
The name/ description of the contents, “Free from Argemone oil”
The mass/ volume of the contents
Name and business particulars of the producer
Net weight of the contents in the container
Batch no, Month and Year of Manufacture
AGMARK if applicable
Labeling Of Edible Oils And Fats
Nutritional Labeling
Nutrition Information
Amount per 100g /Per serving of product
Energy # kcal
Protein # g
Carbohydrates Sugars
# g
Saturated fatty acids Polyunsaturated fatty acids Monounsaturated fatty acids Trans fatty acids Cholesterol
# g # g # g # g # mg
Principal Display Panel (PDP)
PDP- that part of the container/package which is intended or likely to be
displayed or presented or shown or examined by the customer under normal
and customary conditions of display, sale or purchase of the commodity
contained therein
All Mandatory label information shall be given on the PDP
All information required on label shall either be
Grouped together at one place
OR
Pre printed info. at one place and online info. in
another place
Manner Of Declaration
•Regulations for Oils and Fats
36
Regulations related to Fats and Oils
4.4.2 : labeling of edible oils and Fats
1 to 11 section
5.2.2.: Oils
Section 1 to 24
5.2.3 : Intersterified Vegetable Fat
5.2.4 : Partially Hydrogenated Soybean oil
5.2.5 : Edible Fats : Total 10
Regulations related to Fats and Oils
5.2.6 : Margarine and Fat Spreads
5.2.7 : Hydrogenated Vegetable Oils
VANASPATI
BAKERY SHORTENING
FSSAI Requirements
1. Requirement : Employ at least one technical person to
supervise the production process. (The person supervising the production
process shall possess at least a degree in Science with Chemistry/Bio Chemistry/Food
and Nutrition/ Microbiology or a degree or diploma in food technology/ Dairy
technology/ dairy microbiology/ dairy chemistry/ dairy engineering /oil technology
/veterinary science /hotel management & catering technology or any degree or diploma
in any other discipline related to the specific requirements of the business from a
recognized university or institute or equivalent.)
2. Requirement : No producer or manufacturer of vegetable oil, edible oil and
their products shall be eligible for license under this Act, unless he has own
laboratory facility for analytical testing of samples
3. The equipment are made of stainless steel /galvanised iron/ non corrosive
materials.
Challenges in meeting Conditions of Licensing
Requirement : No edible oil is sold/distributed/offered for
sale/dispatched or delivered for purpose of sale unless it is
packed, marked and labelled in the manner specified in the
regulations
Requirement : The food products are bought/sold by the
manufacturer/importer/distributor only from or to
licensed/registered vendors and records are maintained
Challenges - FSSA licensing
REFERENCE PARAMETERS
SPECS
OR
LIMITS
FREQUENCY
Regulation 2.2.1(1) Crop Contaminants
Once in six
months
Aflatoxin 30 ppm
Regulation 2.2.1(2) NOTS
Agaric acid 100 ppm
Hydrocyanic acid 5 ppm
Hypericine 1 ppm
Saffrole 10 ppm
Regulation 2.1.1 Metal Contaminants
Lead 0.5 ppm
Copper 30 ppm
Arsenic 1.1 ppm
Tin 250 ppm
Zinc 50 ppm
Cadmium 1.5 ppm
Mercury 1 ppm
Methyl mercury 0.25 ppm
Regulation 2.3.1 Insecticides
Phenthoate 0.01 ppm
Phorate 0.03 ppm
Claim Classification
Label claims
Nutrition Claim
Nutrient Content Claim
Nutrient Comparative
Claim
Health Claim
Nutrient Function
Claim
Other Function
Claim
Disease risk reduction
claim
Important Definitions
Misbranded Food : Food article with
with false, misleading or deceptive claims
Imitation
False information about origin/manufactuer
Added with non permitted additives
Not declared the additives
Sub Standard food:
If it does not meet the specific standards but not so as to render the article of food unsafe
Important Definitions Contaminant : Present in the food as a result of
production/manufacturing and not included insects/rodent and
extraneous matter.
Extraneous matter : Not unsafe
Unsafe food : Means article of food whose nature, substance or
quality is so affected as to render it injurious to health.
Injury : It includes impirement,whether permanent or
temporary
Classification of offences
Oils & Fats
Mis branding
Sub standard
Unsafe
Court case
Adjudication
Penalties
Order by Adjudication
Officer
Petty Manufacturer
Other FBO’s
Punishable with Fine
Compounding u/s. 69
Enforcement
Appeal to Appellate Tribunal
Prosecution
Commissioner
Enforcement
Appeal to High Court
Punishable with imprisonment
with/without fine Case filed
Court order
Penalties
Penalty for substandard food Rs 5 lacs
Penalty for misbranded food Rs 3 lacs
Penalty on misleading advertisement Rs 10 lacs
Food containing extraneous matter Rs 1 lac
Penalty for failure to comply with food safety officer
Rs 2 lacs
Penalty for unhygienic processing of food Rs 1 lacs
Punishment for unsafe food six months to 10 yrs of
imprisonment
Chapters in the Regulation
Clause No. FSSA RULES
1 General
2 Food Authority and Transaction of Business
3 Licensing and Registration of Food Business
4 Packing and Labeling Regulations
4.1 Packing
4.2 Labeling
4.3 Manner of Declaration
4.4 Restrictions on manner of Labeling
4.7 Notices
5 Food Product Standards
All the food product standards
6 Substances added in food
7 Prohibition and Regulation of Sales
8/9/10 Contaminants Toxins and Residues /Laboratory /Guarantee Appendix A/B/C
Standards for Food Colors
Justice Dispensation System under the Act
ADJUDICATING COURTS
For Misbranding and sub standard
food For unsafe Food
Fine Fine with
Punishment
Recent regulatory Changes
Recent Notifications
FSSA Logo and License number is compulsory on label
Labels of all edible vegetable oils and processed and packaged foods with declared shelf life must bear- (i) Total trans fat content & (ii) Total saturated fat content
Recent Notifications
Standard for vanaspati, bakery shortening, Margarines & interesterified fats have been revised to exclude maximum level of melting point.
Maximum Level of Trans fatty acid in above items fixed at 10 percent.
Enzymatic process allowed for Interesterification of vanaspati and interesterified vegetable fat.
Palm Stearin has been included in the list of permitted edible oils/Fats for Vanaspati
Conclusion
There is a sustainable growth in demand for edible oils in India at a rate of minimum 5% annually
Due to stagnancy in domestic production most of the demand would be met through imports.
Due to change in life style and enhanced purchasing capacity of Indian consumers, there is additional need for specialty fats and new classes of edible oils/fats
Conclusion
The changed regulations envisage wider control on Food Safety including imported foods and Nutraceuticals & Health supplements.
Proprietary foods / New products required product approval from FSSAI, which will be granted upon appropriate risk assessment and product evaluation.
Packaged Food items including imported will have to comply with stringent label declarations
A Separate import clearance system has been put in place wherein each consignments will have to be cleared for its quality specifications and label declarations through chain of NABL Labs.
The new régime of regulations will facilitate further inflow of Palm base oils/Fats
Oil Industry need Support and Nurturing
Synergy in Policy
Procedures ( Path) should be very clear
Positive Participations from all across
Consumer Safety
Consumer safety is priority
No Over loading consumers
WHAT WE NEED
HOPES OF GOOD TOMORROW
