1. Food Packaging Regulation
July 27, 2018
Innovation in Food & Beverage Packaging
Bengaluru
By - Sunil Adsule
Disclaimer: All the Images used herein are for representation purpose only
2. KNOWLEDGE SHARING PARADIGM
Image Courtesy: https://davidparker9.wordpress.com/
Key Stakeholders
• Consumer - Community
• Government - Regulators
• Packaging Manufacturers
• Packaging Converters
• Packaging User
Companies
• Plant / Equipment
Manufacturers
• Ancillary Industries
• Media
• N G Os
3. ❖Primary Function
o To protect food from contamination
o Preserving product integrity, safety
and quality through its desired
shelf life
o Maintain the hygienic conditions
❖Key Add-ons
o Branding - Labeling
o Traceability
o Silent Salesman
o Consumer education
What all a Food Packaging has to do !!!
4. • Packaging innovations driven
by
– Changing incomes and
demographic profiles
– Growing access to Internet and
Smartphones
– Growing Health and
Environmental Consciousness
– Technological Innovations
– Market Competition
598
1256
FY 15 FY 20
Indian Retail Industry
CAGR 16%
USD Bn
Fast growing Indian Retail Industry is demanding innovative &
attractive packaging solutions
Trends driving Food Packaging
5. • Packaged Drinking Water / Mineral water
– Clean drinking water at affordable price point
– Facilitated by plastic packaging development
– Ensured food safety as well as availability
• Retort pouches & Cans
– Development of multilayered retort pouches
ensured availability of food at any time of day
and year
– Products are safe in this formats for years!
• Affordable small pack sizes
– Recent FMCG innovation of Rs. 5/10 pack
ensured food availability at affordable price
point.
– Small size packs meant for quick snacking are
also acting portion control benefitting consumers
Packaging Changes driving Introduction of Food Categories
6. • Evolution of food industry giving better shelf-life &
increased consumption of packaged food fueled
packaging development
• With the increase in range of packaging materials,
heighted concerns of risk of food contamination
• Consumer protection is key driving force for Food
Regulators worldwide
• Therefore many countries developed system of
Packaging regulation to address food safety
Is my milk safe to drink?
Safety of Packaging in Foods
7. • Three pillars of Packaging safety are
– Toxicity of a substance/leachate
– Level of migration of the substance/leachate into a food &
– Level of exposure of that food
• To establish exposure, migration in food and food consumption is
required
• Regulatory Authorities apply conservative approaches to establish
exposure & to determine maximum migration levels
• The burden of ensuring safety RESTS WITH THE MANUFACTURER
Safety of Packaging – Key Issues
8. • Regulations to ensure:
– Safety of human health
– No change in composition of food in unacceptable way
– No change in odour, taste or texture
– Level Playing Field
• Considerable packaging waste is generated where recycling of plastics is prime
area from innovation and sustainability standpoint
• In light of efforts to lower burden on environment Food & Packaging Industry
needs to embrace 3R Approach
– Reduce – Reduce usage of packaging material
– Reuse – Develop Packaging solutions which are Reusable
– Recycle – Collect and recycle food packaging material
Why Have a Regulation
9. Regulation & Good Regulatory Practices (GRP)
• Any Measure or
Intervention
implemented under
Government Authority
• Acts to Control the
behavior of Individuals or
Groups that come within
the ambit of that
authority
Five Principles of GRP
• Good Governance
• Rigorous Impact
Assessment
• Scientific Basis and
Proportionality
• Open Consultation
• Minimal Restrictiveness
What is Regulation
10. • US FDA regulates food packaging materials including additives
• US FDA introduced Food Contact Notification – Jan 2001
– Submissions require information on composition, intended use, additive level, usage
temperature, type of food, data on migration
– Clearance in 120 days
• US FDA Code of Federal Regulations - 21 CFR
– Indirect Food Additives: General - Part 174
– Indirect Food Additives: Adhesives and Components of coatings - Part 175
– Indirect Food Additives: Paper and Paperboard Components - Part 176
– Indirect Food Additives: Polymers - Part 176
Global Regulatory Scenario – US FDA
11. • EU Regulations covers Food Contact Materials and Articles
– General requirements &
– Specific requirements – e.g. for Plastics
• Food Contact Materials & Articles include
– Food Packaging
– Cookware, Cutlery, Tableware
– Work surfaces in food establishments
– Food processing machinery and equipment
• Directive states manufacture of FCN and Articles
– under GMP to ensure no transfer of their constituents to food
• Labeling requirement
– Symbol under Directive 80/590/EEC
Global Regulatory Scenario - EU
12. • Directive 2002/72/EC sets migration limits
– Overall Migration 60 ppm
• Positive list of Permitted Monomers & Starting Substance
– Specific Migration Limits specified
• Testing Compliance for Migration limits
– Directives 82/711/EEC
Global Regulatory Scenario - EU
• EU Regulations:
– Regulation (EC) 2023/2006 - Good manufacturing practice for materials and articles intended to come into
contact with food
– Regulation (EU) 1934/2004 - Materials and articles intended to come into contact with food
– Regulation (EU) 10/2011 - Plastic materials and articles intended to come into contact with food
– Regulation (EC) 282/2008 - Recycled plastic materials and articles intended to come into contact with foods
– Council Directive (84/500/EEC) - The approximation of the laws of the Member States relating to ceramic
articles intended to come into contact with foodstuffs
– Regulation (EC) 1895/2005 – The restriction of use of certain epoxy derivatives in materials and articles
intended to come into contact with food
13. • Food & Drug Act & Regulations 23
– Prohibits use of packages that may impart harmful substances to their contents
• Premarket assessments by Food Directorate
– For finished products such as laminated film or a formulated product like plastic resin
– Suppliers of single additive – antioxidants, UV absorbers
• FD posts positive list of polymers – with Trade and Grade Names
Global Regulatory Scenario - Canada
15. Food Safety and Standards Authority of India (FSSAI ) established in 2008
www.fssai.gov.in
Food
Safety and
Standards
Act, 2006
Prevention of
Food Adulteration
Act, 1954
Fruit Products
Order, 1955
Meat Food
Products Order,
1973
Vegetable Oil
Products
(Control) Order,
1947
Edible Oils
Packaging
(Regulation)
Order, 1998
Solvent Extracted
Oil, Deoiled Meal,
and Edible Flour
(Control) Order,
1967
Milk and Milk
Products Order,
1992
Any other order
under Essential
Commodities Act,
1955 relating to
food
16. FSSAI - As per the Act’s Mandate
Scientific Risk Assessment to drive
Regulation & Rule Making Process
Pesticides and
Antibiotics Residues
Food Authority (Apex Body)
(As per Sections 4 & 5 – FSS Act 2006)
22 Member Body Headed by FSSAI Chairperson
(Final Arbiter of All Regulatory Issues)
Biological hazards
One Scientific Committee (As per Section 14 – FSS Act 2006)
Headed by Eminent Scientist, as SC Chair & Chairpersons of All Scientific Panels and Six
Independent Scientific Experts not belonging
or affiliated to any of the Scientific Panels are members
Food additives, flavourings,
processing aids and
materials in contact with
food
Contaminants in the
food chain
Genetically modified
organisms and foods
Labeling,
Advertising and
Claims
Functional foods,
nutraceuticals, dietetic
products and other similar
products
Method of
sampling and
analysis
Scientific Opinion / Risk
Assessment
Scientific Committee finally responsible for the general co-ordination
necessary to ensure consistency of the scientific opinion procedure
Final Output
Regulation / Rule
Eight Scientific Panels
17. Types of Packaging – Indian Context
Food
Packaging
Materials
Glass
Paper &
Cardboard
Metal
Plastics
Primary Packaging Secondary packaging Tertiary Packaging
Glass
7% Metal
15%
Plastic
s
42%
Paper
31%
Other
5%
Global break up of Packaging
materials
18. • Food Safety and Standards Authority of
India (FSSAI)
– Packaging and Labelling 2011
regulation has section on food
packaging
– Contains adopted Indian Standards on
plastics
– Contains specific milk, edible oil, fruit
and vegetables, canned meat and
Packaged Drinking water requirements
• Bureau of Indian Standards (BIS)
– Sectional committees covering
packaging standard
– General packaging standards for metal,
glass, plastics and paper
■ Limitations of FSSAI and BIS standards
– Packaging requirements defined
as part of labeling requirements
– FSSAI covers only limited
requirements for food packaging.
– Section lacks requirements for
glass, paper
– Many BIS standards generic
nature lack food application
– Many BIS standards need revision
in line with current developments
Indian Regulatory Framework
20. • Definitions – Food Grade, OML & SML, Primary
and Secondary Package
• General requirement applicable to all types of
packaging used for food
• Specific requirements defined
– Paper & board based
– Glass
– Metal &
– Plastics
• Schedules provides – list of BIS standards –
thereby made mandatory
• List of suggestive packaging material based on
food category
Draft FSSR – Packaging – Oct 2017
21. • OML – defined for plastics as 60 mg/kg or 10 mg/dm2 as per
IS 9845
• SML – unlike EU
– focuses on 7 heavy metals – Barium, Cobalt, Copper, Iron, Lithium,
Manganese, Zinc
• Schedule I – Paper and Board
• Schedule II – Metal and Metal Alloys
• Schedule III- Plastics
• Schedule IV – List of Suggestive Packaging Materials
Draft FSSR - Packaging
22. Milk & Milk
Products
Fruit &
Vegetable
Products
Sweets &
Confectionery
Cereal &
Cereal
Products
Meat &
Meat
Products
Beverages
Snacks
Food Packaging
Universe
Ref: Schedule IV – List of Suggestive Packaging Materials
23. Regulatory Focus: Shape of things to come !
CURRENT
• Container dimensions
• Material, Additives,
Printing ink, Adhesive
• Food Grade
• Migration
• Heavy Metals
FUTURE
• Biodegradable
• Reusability
• Recyclability
• Extended Producer
Responsibility
• Carbon footprint
• Ease of disposal
25. Packaging has already become a larger theatre than we thought and started creating
stories – grabbing headlines – most of which our industry does not deserve