Food Regulations: Balancing Safety with Innovation Agenda For - - PowerPoint PPT Presentation

Agenda For Growth: Indian Beverage Industry – Leveraging International Practices

Food Regulations: Balancing Safety with Innovation

Indian Beverage Association April 12, 2013 Joseph Lewis

No Commodity Production/Yr (m MT) 1 Milk 105 2 Tea 0.9 2 Rice 104 2 Fruits & Vegetables 150 3 Food grains 230 3 Fish 7

ABUNDANTLY BLESSED . . .

52% cultivable land (11% world average) 15 major climates 46 of 60 soil types exist

http://www.indiainbusiness.nic.in/industry-infrastructure/industrial-sectors/food-process.htm

India . . A leading producer

300 billion US$ (2013).

• No. 1 Growth

Sector – 7.5% annual

And yet Innovation is a Challenge

 ACIDITY REGULATOR  JECFA: ADI ‘NOT LIMITED’ (1965)  Codex Table 3: in accordance with GMP

Permission to add:

• SODIUM BI CARBONATE (INS 500ii)
• Cooking Soda

Technological Challenge

Tomato Soup

• 2. Standardization: Twofold Effect

Tomato Chutney  Std 2.3.42: Mango Chutney TSS 50%  Std 2.3.41 ‘ Fruit & Vegetable Chutney’  Fruit Chutney TSS 50%  Vegetable Chutney TSS 25%  Hot & Sour (Spicy) TSS 25%

Stan 160-1987: Mango Chutney (Codex)  Creates a mindset of exclusive appropriation.  Illegalizes an honestly labelled product  Imposes its specifications

PROPRIETARY FOODS. . .

 It is not a ‘category of foods’ sharing certain attributes e.g.  Food Supplements  Foods for Special Dietary Uses  It represents an enabling ‘provision’ in food law  to develop and market food products  in an unencumbered manner  Within the applicable regulations.

Access to markets speed to Market

If Product Development is about . . .

Then we need . . . ENABLING REGULATIONS

Food safety & standards act 2006

 FSSA – AN ENABLING FOOD LAW  COMPATIBLE WITH INTERNATIONAL ACTS  HARMONIZE WITH FSSA  RE- CALIBRATE FOCUS

KEY FINDINGS OF THE FICCI 2010 SURVEY % Harmonization with International Regulations (Food Additives, Food Category System, Labeling) 92 Appreciates consolidation of multiple Food Laws 86 Lack of transparency (PFA) 76 Standards are not risk based (PFA) 66 Inconsistent application of regulations by Enforcement Agencies (PFA) 67 * About 1/3rd Industry unaware of FSSA 2006

INDUSTRY EXPECTATIONS

FSSA - Mandate

 The Act requires while framing regulations to:

 Determine food standards on the basis of risk analysis

[18(2)(b)]

 Undertake risk assessment in an independent, objective

and transparent manner [18(2)(c)]

 Carry out risk management which shall include taking into

account the results of risk assessment . . .[18(1)(b)]

It is harmonized . . .

What is ‘ harmonization’ ?

Harmonization: Shift from ‘ text’ to ‘context

1.

ADI not specified : Lower Risk

• Added in accordance with ‘ GMP’
• 170 food additives

R I S K A N A L S I S 2. ADI specified: Higher Risk

• Max levels of use specified
• Food Specified

3. Food Category System

• ‘hierarchical’ allotment

Harmonization – Text or context?

 EU

 Permitted in all foodstuffs, (listed in Annex 1)  Following the ‘ quantum sati's’ principle,

 Australia – Schedule 2 additives may be added – In accordance with GMP  US FDA – Prior Sanctioned – Additives in use prior to 1958 – GRAS – Self Affirmation R I S K A N A L S I S

PRODUCT APPROVAL

Risk Based Separation: Regulate Accordingly

 Aberration: Schedule 1 (VIII)  Notify each food category separately  Retain Proprietary Foods – a provision Unpack Section 22

Freedom to innovate

 Innovate with ‘ Predictability’

 Science based (Evidence)

 Transparent Process

WE ALL WANT SCIENCE BASED . . . “ Washington is a town where people say they

are for science-based decision making until the

• verwhelming scientific consensus leads to a

politically inconvenient conclusion.”

Sherwood Boehlert: Chairman: House Science Committee, US

THANK YOU