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ILSI SEA Region Nutrition Labeling Seminar, Thailand, August 2012 (www.ilsi.org/SEA _Region)
                   Seminar and Workshop on Nutrition Labeling, Claims and
                        Communication Strategies for the Consumer
                                           August 29-31, 2012
                                           Bangkok, Thailand

                                    Organized and Sponsored by
                         ILSI SEA Region / ILSI Thailand Country Committee
                                             Co-organized by
                           Food Science and Technology Association of Thailand


                         Session 1
        Nutrition Labeling and Claims: Regulatory
               Updates and Future Directions
      Nutrition Labeling and Claims: INDIA Updates.
                          Dr Anantha Narayana,
                   Retired Director, Regulatory Affairs,
      Unilever Research India, Bangalore. dba.narayana@gmail.com

                                             ILSI.BKK.12.DBA.                              1
Nutrition Labeling and Claims: INDIA Updates.

              Coverage of Presentation
• Transitions of Food regulations from PFA to FSSA.
• Labeling requirements, current status,& issues
• Nutrition and Health Claims-current status for foods
• Food Supplements, FSDU’s, Infant Foods, Novel
  Foods &others
• Industry demands for N&H Claims.
• Need for Clarity and role of bodies like ILSI/Codex.


                        ILSI.BKK.12.DBA.                 2
Transitions of Food regulations from PFA to FSSA.
                                           • Notified FSSA Rules -
                                           6thAugsut,2011.
                                           • Labeling and Claims
                                           regulations not yet fully
                                           reviewed .
                                           • Retained most of the
                                           Regulations related to
                                           Labeling-over 20 years
& 20 or
                                           experience and insights.
more
                                           • Standard Foods
Regulations                                • Proprietary Foods
related to                                 • Food Supplements, FSDU’s,
foods                                      Infant Foods, Novel Foods
                                           &others
                                               INDIAN FOOD CODE PUBLISHED-
                                                   9th July,2012.
                        ILSI.BKK.12.DBA.                               3
www.fssai.gov.in




                   ILSI.BKK.12.DBA.   4
What governs labeling of foods
• Right to Information on foods –what it is, what it is
  made up of, how to use, how much to use, nutrition
  information, storage information, and so on.
• Right to information on “durability”
• Right to know about any thing that I need to take
  care.
• How much/how many are in the packet and what do
  I pay for it.
• Foods Regulations/Weight & Measures regulations.
• Genetically Modified/Organic/Natural
• 3rd Party Guidance/Certifications

                        ILSI.BKK.12.DBA.                  5
Standard foods
 • For those where the FSSA Rules provide standards.
                                            3                                        2
>300 Std foods.                                                                              1




     Disclaimer: Label scans shown are only as examples, taken at random, speaker does not
     endorse or own these in any way.    ILSI.BKK.12.DBA.                                    6
Proprietary Foods




Disclaimer: Label scans shown are only as examples, taken at random, speaker does not
endorse or own these in any way.    ILSI.BKK.12.DBA.                                    7
Foods –Advisories

                               •Specific Advisories
                        • Vulnerable populations
                        • Allergens
                        • GMO (?)
                        • Irradiated foods
                        • Permitted
                        sweeteners/preservatives/Color
                        & Flavors (Natural-NI-
                        Synthetic)/stabilizers…. In some
                        cases even qty.




     ILSI.BKK.12.DBA.                                 8
Indian Foods Labeling- need review
• 2 Committees under FICCI and CII have debated the need for and
  contours of the reviews needed.
• DS Chadha Committee has given their recommendations.
• ILSI had also organized a discussion on labeling.
                       • Reasons for review:
•   Information overload.
•   Repetitive information.
•   Too many information to be boxed.
•   Nutrition labeling – Do the Consumer really understand?
    ;RDA’s Indian Vs US – confusions
•   Clear Categories- Advisory in Place & Food/Health
    Supplements regulations yet to come out

                               ILSI.BKK.12.DBA.                    9
Nutrition and Health Claims-current status for foods
• Status Quo continues-as it was during PFA regime.
• Consultations and Discussions in Scientific Panels-On
• Most Drafts discussed revolve around/adopt/build
  on CODEX Guidelines for Nutrition & Health Claims.
• Regulations on –Nutraceuticals/Food
  Supplements/FSDU’s/Novel Foods are in the offing.
• Pre approved Claims have not been notified so far.
• Discussions on oversight of Claims under way-
• A 3 TIER approach is under consideration- During
  Licensing; oversee through Advertising Standards
  Council of India[ASCI]; and FSSAI retaining final
  authority
                        ILSI.BKK.12.DBA.                10
Definition of Nutrition Claim/s
Nutrition claim means any representation which states, suggests
   or implies that a food has particular nutritional properties
    - Include energy value, protein, fat and carbohydrates, vitamins
    and minerals
    - What does not constitute nutrition claims:
      Mandated - Listing of Ingredients - Nutrition Panel - QUID
Nutrient content claim is a nutrition claim that describes the
   level of a nutrient contained in a food. (Examples: “source of
   calcium”; “high in fibre and low in fat”.)

Nutrient comparative claim is a claim that compares the
   nutrient levels and/or energy value of two or more foods.
   (Examples: “reduced”; “less than”; “fewer”; “increased”; “more
   than”.)

                                      ILSI.BKK.12.DBA.                 11
Definition of Health Claim/s
Health claim any representation that states, suggests or
   implies of relationship between
   - a Food or
   - a Constituent of that Food &
   - Health
Health claims include
   - Nutrient function claims - a nutrition claim that describes
    the physiological role of the nutrient in growth, development
    and normal functions of the body
    - Other function claims - Specific beneficial effects of food
    consumption on normal functions or biological activities of
    the body
    - Reduction of disease risk claims - Linking consumption of a
    food to the reduced risk of developing a disease or health-
    related condition
                                     ILSI.BKK.12.DBA.               12
Industry demands for N&H Claims
• Industry has worked under an expert committee
  under Federation of Indian Chamber of Commerce&
  Industries –FICCI-Foods Panel.
• Submitted draft Guidelines- Aligned with Codex
  Guidelines.
  –   Notify Guidelines
  –   No-premarket approval steps(except for novel foods)
  –   Notification of pre-approved claims list
  –   Oversee through ASCI.
  –   Time bound review process, where required


                           ILSI.BKK.12.DBA.                 13
Need for Clarity and role of bodies like ILSI/Codex.




                       ILSI.BKK.12.DBA.                14
www.ascionline.org




ILSI.BKK.12.DBA.             15
Need for Clarity and role of bodies like ILSI/Codex.

• What level of Scientific Evidence /review process
•  Would Human Intervention studies in India be made
  mandatory?
• Would Clinical trials have to follow GCP Guidelines
  that are published for Drugs ?
• Would there be need for and a process for getting
  FSSAI’s approval for Human Intervention Studies to
  be conducted in India?
• Recognition of would history of use data on many
  botanicals known and used in India for centuries.

                          ILSI.BKK.12.DBA.                 16
Breaking News
• The Scientific Panel on Labeling & Claims have
  finalized “Draft Guidelines for Labeling and
  Claims” in its meeting held on 9th August,2012
• Time to study and send inputs to FSSAI as
  soon as it is put up for Comments.



         THANK YOU FOR A PATIENT
                HEARING.
                     ILSI.BKK.12.DBA.          17

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Nutrition Labeling & Claims India 2012

  • 1. ILSI SEA Region Nutrition Labeling Seminar, Thailand, August 2012 (www.ilsi.org/SEA _Region) Seminar and Workshop on Nutrition Labeling, Claims and Communication Strategies for the Consumer August 29-31, 2012 Bangkok, Thailand Organized and Sponsored by ILSI SEA Region / ILSI Thailand Country Committee Co-organized by Food Science and Technology Association of Thailand Session 1 Nutrition Labeling and Claims: Regulatory Updates and Future Directions Nutrition Labeling and Claims: INDIA Updates. Dr Anantha Narayana, Retired Director, Regulatory Affairs, Unilever Research India, Bangalore. dba.narayana@gmail.com ILSI.BKK.12.DBA. 1
  • 2. Nutrition Labeling and Claims: INDIA Updates. Coverage of Presentation • Transitions of Food regulations from PFA to FSSA. • Labeling requirements, current status,& issues • Nutrition and Health Claims-current status for foods • Food Supplements, FSDU’s, Infant Foods, Novel Foods &others • Industry demands for N&H Claims. • Need for Clarity and role of bodies like ILSI/Codex. ILSI.BKK.12.DBA. 2
  • 3. Transitions of Food regulations from PFA to FSSA. • Notified FSSA Rules - 6thAugsut,2011. • Labeling and Claims regulations not yet fully reviewed . • Retained most of the Regulations related to Labeling-over 20 years & 20 or experience and insights. more • Standard Foods Regulations • Proprietary Foods related to • Food Supplements, FSDU’s, foods Infant Foods, Novel Foods &others INDIAN FOOD CODE PUBLISHED- 9th July,2012. ILSI.BKK.12.DBA. 3
  • 4. www.fssai.gov.in ILSI.BKK.12.DBA. 4
  • 5. What governs labeling of foods • Right to Information on foods –what it is, what it is made up of, how to use, how much to use, nutrition information, storage information, and so on. • Right to information on “durability” • Right to know about any thing that I need to take care. • How much/how many are in the packet and what do I pay for it. • Foods Regulations/Weight & Measures regulations. • Genetically Modified/Organic/Natural • 3rd Party Guidance/Certifications ILSI.BKK.12.DBA. 5
  • 6. Standard foods • For those where the FSSA Rules provide standards. 3 2 >300 Std foods. 1 Disclaimer: Label scans shown are only as examples, taken at random, speaker does not endorse or own these in any way. ILSI.BKK.12.DBA. 6
  • 7. Proprietary Foods Disclaimer: Label scans shown are only as examples, taken at random, speaker does not endorse or own these in any way. ILSI.BKK.12.DBA. 7
  • 8. Foods –Advisories •Specific Advisories • Vulnerable populations • Allergens • GMO (?) • Irradiated foods • Permitted sweeteners/preservatives/Color & Flavors (Natural-NI- Synthetic)/stabilizers…. In some cases even qty. ILSI.BKK.12.DBA. 8
  • 9. Indian Foods Labeling- need review • 2 Committees under FICCI and CII have debated the need for and contours of the reviews needed. • DS Chadha Committee has given their recommendations. • ILSI had also organized a discussion on labeling. • Reasons for review: • Information overload. • Repetitive information. • Too many information to be boxed. • Nutrition labeling – Do the Consumer really understand? ;RDA’s Indian Vs US – confusions • Clear Categories- Advisory in Place & Food/Health Supplements regulations yet to come out ILSI.BKK.12.DBA. 9
  • 10. Nutrition and Health Claims-current status for foods • Status Quo continues-as it was during PFA regime. • Consultations and Discussions in Scientific Panels-On • Most Drafts discussed revolve around/adopt/build on CODEX Guidelines for Nutrition & Health Claims. • Regulations on –Nutraceuticals/Food Supplements/FSDU’s/Novel Foods are in the offing. • Pre approved Claims have not been notified so far. • Discussions on oversight of Claims under way- • A 3 TIER approach is under consideration- During Licensing; oversee through Advertising Standards Council of India[ASCI]; and FSSAI retaining final authority ILSI.BKK.12.DBA. 10
  • 11. Definition of Nutrition Claim/s Nutrition claim means any representation which states, suggests or implies that a food has particular nutritional properties - Include energy value, protein, fat and carbohydrates, vitamins and minerals - What does not constitute nutrition claims:  Mandated - Listing of Ingredients - Nutrition Panel - QUID Nutrient content claim is a nutrition claim that describes the level of a nutrient contained in a food. (Examples: “source of calcium”; “high in fibre and low in fat”.) Nutrient comparative claim is a claim that compares the nutrient levels and/or energy value of two or more foods. (Examples: “reduced”; “less than”; “fewer”; “increased”; “more than”.) ILSI.BKK.12.DBA. 11
  • 12. Definition of Health Claim/s Health claim any representation that states, suggests or implies of relationship between - a Food or - a Constituent of that Food & - Health Health claims include - Nutrient function claims - a nutrition claim that describes the physiological role of the nutrient in growth, development and normal functions of the body - Other function claims - Specific beneficial effects of food consumption on normal functions or biological activities of the body - Reduction of disease risk claims - Linking consumption of a food to the reduced risk of developing a disease or health- related condition ILSI.BKK.12.DBA. 12
  • 13. Industry demands for N&H Claims • Industry has worked under an expert committee under Federation of Indian Chamber of Commerce& Industries –FICCI-Foods Panel. • Submitted draft Guidelines- Aligned with Codex Guidelines. – Notify Guidelines – No-premarket approval steps(except for novel foods) – Notification of pre-approved claims list – Oversee through ASCI. – Time bound review process, where required ILSI.BKK.12.DBA. 13
  • 14. Need for Clarity and role of bodies like ILSI/Codex. ILSI.BKK.12.DBA. 14
  • 16. Need for Clarity and role of bodies like ILSI/Codex. • What level of Scientific Evidence /review process • Would Human Intervention studies in India be made mandatory? • Would Clinical trials have to follow GCP Guidelines that are published for Drugs ? • Would there be need for and a process for getting FSSAI’s approval for Human Intervention Studies to be conducted in India? • Recognition of would history of use data on many botanicals known and used in India for centuries. ILSI.BKK.12.DBA. 16
  • 17. Breaking News • The Scientific Panel on Labeling & Claims have finalized “Draft Guidelines for Labeling and Claims” in its meeting held on 9th August,2012 • Time to study and send inputs to FSSAI as soon as it is put up for Comments. THANK YOU FOR A PATIENT HEARING. ILSI.BKK.12.DBA. 17