SlideShare uma empresa Scribd logo
1 de 32
ILSI SEA Region Nutrition Labeling Seminar, Thailand, August 2012 (www.ilsi.org/SEA _Region)
Updates on Nutrition Labelling and
   Claims Regulation in Europe

                    Sean (JJ) Strain
             President, The Nutrition Society
Professor of Human Nutrition and Director of the Northern
           Ireland Centre for Food & Health (UK)

                    jj.strain@ulster.ac.uk
Updates on Nutrition Labelling and
   Claims Regulation in Europe

• General considerations



• Weighing the evidence
Updates on Nutrition Labelling and
   Claims Regulation in Europe


• General considerations



• Weighing the evidence
‘Taco Bell
                                               Nineteen-year-old
                                               Alicia Vargas of
                                               Yuma, AZ, avoids
                                               getting pregnant
                                               with a delicious
                                               ContraceptiMelt’




Source: The Onion, March 12, 1997
http://www.theonion.com/content/node/29938/print/
What EFSA cannot do
• Be responsible for food safety legislation
• Take charge of food safety/quality controls,
  labelling or other such issues
• Act as a substitute for national authorities
NDA Panel & Working Groups

                         Safety and suitability
Safety
                                                         Safety
                         Infant Formulae
         Novel Foods
                                              Upper Levels
                        NDA Panel
Dietary Reference
                         21 Members
      Values                                  Food Allergy
                            Claims
   Scientific advice                                         Safety
                   Evaluation of scientific substantiation

                Supported by the EFSA Nutrition Unit
Regulation (EC) No 1924/2006 of the
    European Parliament and of the Council

• Article 5: General conditions: The use of nutrition
  and health claims shall only be permitted if the
  following conditions are fulfilled: (a) the
  presence, absence or reduced content in a food
  or category of food of a nutrient or other
  substance in respect of which the claim is made
  has been shown to have a beneficial nutritional
  or physiological effect claimed as established by
  generally accepted scientific evidence
What EFSA can do
• Recital 17: A claim should be scientifically substantiated by
  taking into account the totality of the available scientific
  evidence, and by weighing the evidence

• Recital 23: Health claims should only be authorised for use in
  the Community after a scientific assessment of the highest
  possible standard. In order to ensure harmonised scientific
  assessment of these claims, the European Food Safety
  Authority should carry out such assessments.

• Article 6: Nutrition and health claims shall be based on and
  substantiated by generally accepted scientific evidence
What EFSA was expected to do
• Recital 26: Health claims other than those
  referring to the reduction of disease risk and to
  children’s development and health, based on
  generally accepted scientific evidence, should
  undergo a different type of assessment and
  authorisation. It is therefore necessary to adopt
  a Community list of such permitted claims after
  consulting the European Food Safety Authority.
Health claims

                      Article 13                           Article 14
a) Growth & development &          Based on newly   Reduction of disease
functions of body                  developed        risk (risk factor
                                   scientific       reduction) and claims
b) Psychological & behavioural                      referring to children’s
                                   evidence or
functions                                           development and
                                   requesting
                                                    health
c) Slimming or weight control or   protection of
reduction in sense of hunger or    proprietary
increase in sense of satiety or    data
reduction of available energy
Based on generally accepted
                                   Article 13.5
scientific evidence
            Article 13.1
Advantages of Submission by Dossier
Allows:
1. Complete characterisation of the food which is
    the subject of the claim
2. Full description of the health relationship
    claimed and any underlying hypotheses
3. Clear indication of decision tree for collecting
    the pertinent studies
4. Case to be made for substantiation on the basis
    of the pertinent studies
5. Dialogue between Applicant and EFSA in order
    to clarify any issues arising
ID                                       Health
          Food or Food constituent                             Proposed wording
                                      Relationship
561   Xylitol-sweetened     chewing Ears               Xylitol is good for the health of
      gum                                              ears.
                                                       Maintains good health of the ears.




      Conditions of use
      -    Chewing gums with 65% xylitol. 2 pieces 3-5 times per day. The product may not
           contain sugars capable of fermentation and the requirements for other Finnish
           Dental Association recommendations must be fulfilled.
The Citation Newsletter

Ezekiel 27.17 The Old Testament In: The Holy Bible.
ID 3668: “Panax ginseng (common name: Asian, Korean ginseng)” and
“cognitive performance”
Full text: Judah and Israel gave you their finest wheat, fancy figs, honey, olive oil,
and spices in exchange for your merchandise.
Beck, L, The complete idiot’s guide to total nutrition for Canadians.
Hellmann J, 2006. Data in preparation – confidential. Intervention (n = 46). Study
finished in May 2006
Anonymous, 2007. Andenne Omega3 – Menu. Not published intervention trial,
realized from January to June 2007, Andenne, Belgium
Tea association, 2003. Classical drink as trend: tea consumption stable at a high
level. German tea industry satisfied with financial year. Press release
The Clarification Newsletter
Food:
Before: “Vitamins, minerals, lysine and/or taurine”
After: “Combination of different vitamins and minerals, lysine and/or argine
and/or taurine”
Before: “Carbohydrates from pasta”
After: “Pasta from different kinds of cereal grains, e.g. durum wheat, wheat,
barley, oat and rye. Except autoclaved products”
Before: “Green tea extract (Camelia sinesis)
After: “Green tea extract (Camelia senesis); People have always been plagued
by high blood pressure, which is triggered by the loss of elasticity in the…
Before: “Antioxidants”
After: “Antioxidants (Source of antioxidants from the list of health claims
given a positive opinion by EFSA)”
ID

          Food or Food
                                Health Relationship               Proposed wording
           constituent


561   Xylitol-           Ears                              Xylitol is good for the health of
      sweetened          Clarification provided            ears.
      chewing gum
                         Ears Clarification: Inhibits the Maintains good health of the
                         absorption of cholesterol.       ears.
                         Heart Health      and    artery
                         health

      Conditions of use
      -     Chewing gums with 65% xylitol. 2 pieces 3-5 times per day. The product may
            not contain sugars capable of fermentation and the requirements for other
            Finnish Dental Association recommendations must be fulfilled.
Article 13.1 is best suited to essential
               nutrient claims
1. All essential nutrients are sufficiently
   characterised.
2. Health relationships are generally straight
   forward and well known.
3. In general, all have clear biochemical and
   physiological (functional) roles which often can
   be linked to clinical symptoms of deficiency and
   it is relatively simple to establish causality.
Calcium and nerve function

• Well established science



• But where is the evidence?
Nutrition Labeling & Claims EU 2012
Milk Fever
How do we weigh sick cows?
Health claims

                      Article 13                           Article 14
a) Growth & development &          Based on newly   Reduction of disease
functions of body                  developed        risk (risk factor
                                   scientific       reduction) and claims
b) Psychological & behavioural                      referring to children’s
                                   evidence or
functions                                           development and
                                   requesting
                                                    health
c) Slimming or weight control or   protection of
reduction in sense of hunger or    proprietary
increase in sense of satiety or    data
reduction of available energy
Based on generally accepted
                                   Article 13.5
scientific evidence
            Article 13.1
Where did it all go wrong?
       EC COM (2003) 0424

• Being based on long-established and non-
  controversial science, health claims that describe
  the role of a nutrient or other substance in growth,
  development and normal physiological functions of
  the body shall undergo a different type of
  assessment….
       EC 1924/2006

• Based on generally accepted scientific evidence….
Health claims

                      Article 13                           Article 14
a) Growth & development &          Based on newly   Reduction of disease
functions of body                  developed        risk (risk factor
                                   scientific       reduction) and claims
b) Psychological & behavioural                      referring to children’s
                                   evidence or
functions                                           development and
                                   requesting
                                                    health
c) Slimming or weight control or   protection of
reduction in sense of hunger or    proprietary
increase in sense of satiety or    data
reduction of available energy
Based on generally accepted
                                   Article 13.5
scientific evidence
            Article 13.1
Updates on Nutrition Labelling
and Claims Regulation in Europe

• General considerations


• Weighing the evidence
Points to consider in determining whether a
             study is pertinent to the claim:
1. Human dietary studies are central for the substantiation of
   the claim.

2. Does the study address the food constituent which has been
   characterised in the application?

3. Does the study address endpoints of relevance to the health
   relationship as defined in the application?

4. Is the study in the target population as indicated in the
   application or could it be extrapolated to the target
   population?
Points to consider in determining whether a
         study is pertinent to the claim:
5. Is the dosage and/or food matrix relevant to the proposed condition of
   use as defined in the application?

6. Are supportive studies in animals or in vitro relevant for the claimed
   effect?

7. The human studies meeting all of the criteria outlined in 1-5 together
   with the relevant supportive studies identified in 6 should be regarded
   as the pertinent studies on which to base the substantiation.

8. If the opinion might be favourable from the references provided a check
   should be performed to confirm whether the references reflect the
   totality of the evidence in the literature.
Five conditions of causality
• Ability to manipulate the effect
• Specificity of cause and effect
• Consistent associations with outcome
  measures
• Dose response relationship
• Plausible biological mechanism
Concluding on a cause and
              effect relationship
• A cause and effect relationship has been established
  between the consumption of the food and the beneficial
  physiological effect

• A cause and effect relationship has not been established
  between the consumption of the food and the beneficial
  physiological effect

• The evidence provided is insufficient to establish a cause
  and effect relationship between the consumption of the
  food and the beneficial physiological effect
Conclusion on calcium and
           neurotransmission
• The Panel considers that a cause and effect
  relationship has been established between
  calcium and normal muscle function and
  neurotransmission. However, the evidence
  provided does not establish that inadequate
  intake of calcium leading to impaired muscle
  function and neurotransmission occurs in the
  general EU population.
EFSA health claims evaluation status
                                                       (31 July 2012)
                                                                                                   In        Under
Claim type                              Received        Withdrawn             Adopted                      Validation
                                                                                                progress
                                                                             53 opinions
Children (Article 14)                      220               110              covering 60         0*          50
                                                                              applications

Disease risk reduction                                                       32 opinions
                                            58                23              covering 33         0**          2
(Article 14)                                                                  applications

New science/ proprietary                                                     61 opinions
                                           103                17              covering 62        18***         6
(Article 13.5)                                                                applications

Conditions of use (Article
                                            2                 0                     2              0           0
19)
                                                                                  148
Total applications                         383               150            opinions covering     18          58
                                                                            157 applications

Article 13.1 list of health                                                      2849                        1548
                                          4728               331                                   0
claims                                                                       (2776 published)               (on hold)

             * 0 in clock stop   ** 0 in clock stop   *** 0 in clock stop
Examples of positive health claims
                                  evaluations (> 200)

Claim                               Food/constituent
LDL cholesterol and risk of heart   Phytosterols, oat -glucan, replacing
disease                             saturated fats by unsaturated fats
Dental plaque and risk of caries    Sugar-free chewing gum
Body weight                         Meal replacements, VLCD
Bowel function                      Cereal fibres (wheat, barley, oat, rye)
Blood glucose after meals           Pectins, guar gum, resistant starch,
                                    sugar replacers
Blood pressure                      potassium, reduced sodium
Lactose digestion                   Yoghurt live bacterial cultures
Platelet aggregation                Water sol. tomato conc.

Mais conteúdo relacionado

Mais procurados

FSSAI REGULATIONS FOR THE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN I...
FSSAI REGULATIONS FOR THE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN I...FSSAI REGULATIONS FOR THE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN I...
FSSAI REGULATIONS FOR THE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN I...Swapnil Fernandes
 
REGULATORY CONSIDERATIONS IN JAPAN.pptx
REGULATORY CONSIDERATIONS IN JAPAN.pptxREGULATORY CONSIDERATIONS IN JAPAN.pptx
REGULATORY CONSIDERATIONS IN JAPAN.pptxAartiVats5
 
REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS A GLOBAL
REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS A GLOBALREGULATORY ASPECTS OF FOOD & NUTRACEUTICALS A GLOBAL
REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS A GLOBALKapilKumar198
 
Plasma master file
Plasma master filePlasma master file
Plasma master fileSridhar S
 
Plasma drug file and TSE/ BSE evaluation
Plasma drug file and TSE/ BSE evaluationPlasma drug file and TSE/ BSE evaluation
Plasma drug file and TSE/ BSE evaluationShoba Elangovan
 
GOOD AUTOMATED LABORATORY PRACTICE
GOOD AUTOMATED LABORATORY PRACTICEGOOD AUTOMATED LABORATORY PRACTICE
GOOD AUTOMATED LABORATORY PRACTICEjagrutivasava
 
Medical device regulation US, European Union and India
Medical device regulation  US, European Union and IndiaMedical device regulation  US, European Union and India
Medical device regulation US, European Union and IndiaCSIR-URDIP, NCL Campus, Pune
 
Changes to an approved NDA and ANDA Regulatory considerations for manufacturi...
Changes to an approved NDA and ANDA Regulatory considerations for manufacturi...Changes to an approved NDA and ANDA Regulatory considerations for manufacturi...
Changes to an approved NDA and ANDA Regulatory considerations for manufacturi...BhavikaAPatel
 
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Swapnil Fernandes
 
Drug Registration in ASEAN Countries.pptx
Drug Registration in ASEAN Countries.pptxDrug Registration in ASEAN Countries.pptx
Drug Registration in ASEAN Countries.pptxbhavuk11
 
IDE Application Process and Best Practices
IDE Application Process and Best PracticesIDE Application Process and Best Practices
IDE Application Process and Best PracticesCFTCC
 
Regulatory approval process for invitro diagnostics in us
Regulatory approval process for invitro diagnostics in usRegulatory approval process for invitro diagnostics in us
Regulatory approval process for invitro diagnostics in usVinod Raj
 
Labeling/Advertising and Promotion, Import/Export, and Enforcement Actions
Labeling/Advertising and Promotion, Import/Export, and Enforcement ActionsLabeling/Advertising and Promotion, Import/Export, and Enforcement Actions
Labeling/Advertising and Promotion, Import/Export, and Enforcement ActionsMichael Swit
 
International Medical Device Regulators Forum
International Medical Device Regulators ForumInternational Medical Device Regulators Forum
International Medical Device Regulators ForumSanthiNori1
 
Regulatory guidelines for the development of biologics in
Regulatory guidelines for the development of biologics inRegulatory guidelines for the development of biologics in
Regulatory guidelines for the development of biologics inJAYA PRAKASH VELUCHURI
 
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
 

Mais procurados (20)

FSSAI REGULATIONS FOR THE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN I...
FSSAI REGULATIONS FOR THE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN I...FSSAI REGULATIONS FOR THE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN I...
FSSAI REGULATIONS FOR THE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN I...
 
New EU Novel Food Regs - What Happens Next?
New EU Novel Food Regs - What Happens Next?New EU Novel Food Regs - What Happens Next?
New EU Novel Food Regs - What Happens Next?
 
REGULATORY CONSIDERATIONS IN JAPAN.pptx
REGULATORY CONSIDERATIONS IN JAPAN.pptxREGULATORY CONSIDERATIONS IN JAPAN.pptx
REGULATORY CONSIDERATIONS IN JAPAN.pptx
 
Medical Device Regulations - 510(k) Process
Medical Device Regulations - 510(k) ProcessMedical Device Regulations - 510(k) Process
Medical Device Regulations - 510(k) Process
 
REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS A GLOBAL
REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS A GLOBALREGULATORY ASPECTS OF FOOD & NUTRACEUTICALS A GLOBAL
REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS A GLOBAL
 
Plasma master file
Plasma master filePlasma master file
Plasma master file
 
Plasma drug file and TSE/ BSE evaluation
Plasma drug file and TSE/ BSE evaluationPlasma drug file and TSE/ BSE evaluation
Plasma drug file and TSE/ BSE evaluation
 
GOOD AUTOMATED LABORATORY PRACTICE
GOOD AUTOMATED LABORATORY PRACTICEGOOD AUTOMATED LABORATORY PRACTICE
GOOD AUTOMATED LABORATORY PRACTICE
 
Medical device regulation US, European Union and India
Medical device regulation  US, European Union and IndiaMedical device regulation  US, European Union and India
Medical device regulation US, European Union and India
 
RDA Europe Nodes
RDA Europe NodesRDA Europe Nodes
RDA Europe Nodes
 
Changes to an approved NDA and ANDA Regulatory considerations for manufacturi...
Changes to an approved NDA and ANDA Regulatory considerations for manufacturi...Changes to an approved NDA and ANDA Regulatory considerations for manufacturi...
Changes to an approved NDA and ANDA Regulatory considerations for manufacturi...
 
STED
STEDSTED
STED
 
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...
 
Drug Registration in ASEAN Countries.pptx
Drug Registration in ASEAN Countries.pptxDrug Registration in ASEAN Countries.pptx
Drug Registration in ASEAN Countries.pptx
 
IDE Application Process and Best Practices
IDE Application Process and Best PracticesIDE Application Process and Best Practices
IDE Application Process and Best Practices
 
Regulatory approval process for invitro diagnostics in us
Regulatory approval process for invitro diagnostics in usRegulatory approval process for invitro diagnostics in us
Regulatory approval process for invitro diagnostics in us
 
Labeling/Advertising and Promotion, Import/Export, and Enforcement Actions
Labeling/Advertising and Promotion, Import/Export, and Enforcement ActionsLabeling/Advertising and Promotion, Import/Export, and Enforcement Actions
Labeling/Advertising and Promotion, Import/Export, and Enforcement Actions
 
International Medical Device Regulators Forum
International Medical Device Regulators ForumInternational Medical Device Regulators Forum
International Medical Device Regulators Forum
 
Regulatory guidelines for the development of biologics in
Regulatory guidelines for the development of biologics inRegulatory guidelines for the development of biologics in
Regulatory guidelines for the development of biologics in
 
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...
 

Semelhante a Nutrition Labeling & Claims EU 2012

From the design to validation of health claims. What about claims and food be...
From the design to validation of health claims. What about claims and food be...From the design to validation of health claims. What about claims and food be...
From the design to validation of health claims. What about claims and food be...comfoodforhealth
 
ScienceCafé Zeist: Voeding 10-11-11
ScienceCafé Zeist:  Voeding 10-11-11ScienceCafé Zeist:  Voeding 10-11-11
ScienceCafé Zeist: Voeding 10-11-11Science Café Zeist
 
Final functional foods backgrounder
Final functional foods backgrounderFinal functional foods backgrounder
Final functional foods backgrounderVanessa Alonso
 
Functional Foods: Their Role & Opportunities
Functional Foods:  Their Role & OpportunitiesFunctional Foods:  Their Role & Opportunities
Functional Foods: Their Role & Opportunitiessenaimais
 
Functional Foods and Nutraceuticals
Functional Foods and Nutraceuticals Functional Foods and Nutraceuticals
Functional Foods and Nutraceuticals Gaston Adoyo
 
From  Nutrigenomics to Systems Nutrition - The role of nutrition in metabolic...
From  Nutrigenomics to Systems Nutrition - The role of nutrition in metabolic...From  Nutrigenomics to Systems Nutrition - The role of nutrition in metabolic...
From  Nutrigenomics to Systems Nutrition - The role of nutrition in metabolic...Norwich Research Park
 
Functional foods health claims, regulations and
Functional foods  health claims, regulations andFunctional foods  health claims, regulations and
Functional foods health claims, regulations andSubhajit Majumdar
 
Lab Report On Biochemical Assessment
Lab Report On Biochemical AssessmentLab Report On Biochemical Assessment
Lab Report On Biochemical AssessmentLindsey Campbell
 
1-s2.0-S0002838X22001095.pdf
1-s2.0-S0002838X22001095.pdf1-s2.0-S0002838X22001095.pdf
1-s2.0-S0002838X22001095.pdfPutriNahrisaNst
 
Mintel_Kiwi_for_Irritable_Bowel_Syndrome_IBS
Mintel_Kiwi_for_Irritable_Bowel_Syndrome_IBSMintel_Kiwi_for_Irritable_Bowel_Syndrome_IBS
Mintel_Kiwi_for_Irritable_Bowel_Syndrome_IBSWayne Mulligan
 
An Analysis Of A Few Diets, Worldwide
An Analysis Of A Few Diets, WorldwideAn Analysis Of A Few Diets, Worldwide
An Analysis Of A Few Diets, WorldwideMartin Mongiello
 

Semelhante a Nutrition Labeling & Claims EU 2012 (20)

Update on Nutrition Labeling and Claims Regulation in EU 2012
Update on Nutrition Labeling and Claims Regulation in EU 2012Update on Nutrition Labeling and Claims Regulation in EU 2012
Update on Nutrition Labeling and Claims Regulation in EU 2012
 
From the design to validation of health claims. What about claims and food be...
From the design to validation of health claims. What about claims and food be...From the design to validation of health claims. What about claims and food be...
From the design to validation of health claims. What about claims and food be...
 
ScienceCafé Zeist: Voeding 10-11-11
ScienceCafé Zeist:  Voeding 10-11-11ScienceCafé Zeist:  Voeding 10-11-11
ScienceCafé Zeist: Voeding 10-11-11
 
Final functional foods backgrounder
Final functional foods backgrounderFinal functional foods backgrounder
Final functional foods backgrounder
 
Substantiate What One Claims: Claim Only What Has Been Substantiated
Substantiate What One Claims: Claim Only What Has Been SubstantiatedSubstantiate What One Claims: Claim Only What Has Been Substantiated
Substantiate What One Claims: Claim Only What Has Been Substantiated
 
Nutrition Labeling & Claims Thailand 2012
Nutrition Labeling & Claims Thailand 2012Nutrition Labeling & Claims Thailand 2012
Nutrition Labeling & Claims Thailand 2012
 
Functional Foods: Their Role & Opportunities
Functional Foods:  Their Role & OpportunitiesFunctional Foods:  Their Role & Opportunities
Functional Foods: Their Role & Opportunities
 
Functional Foods and Nutraceuticals
Functional Foods and Nutraceuticals Functional Foods and Nutraceuticals
Functional Foods and Nutraceuticals
 
functional food llegislation-introduction-1 lec.
functional food llegislation-introduction-1 lec.functional food llegislation-introduction-1 lec.
functional food llegislation-introduction-1 lec.
 
Integrative Pediatric Rheumatology: How to help parents make the best decisio...
Integrative Pediatric Rheumatology: How to help parents make the best decisio...Integrative Pediatric Rheumatology: How to help parents make the best decisio...
Integrative Pediatric Rheumatology: How to help parents make the best decisio...
 
From  Nutrigenomics to Systems Nutrition - The role of nutrition in metabolic...
From  Nutrigenomics to Systems Nutrition - The role of nutrition in metabolic...From  Nutrigenomics to Systems Nutrition - The role of nutrition in metabolic...
From  Nutrigenomics to Systems Nutrition - The role of nutrition in metabolic...
 
Functional foods health claims, regulations and
Functional foods  health claims, regulations andFunctional foods  health claims, regulations and
Functional foods health claims, regulations and
 
Lab Report On Biochemical Assessment
Lab Report On Biochemical AssessmentLab Report On Biochemical Assessment
Lab Report On Biochemical Assessment
 
1-s2.0-S0002838X22001095.pdf
1-s2.0-S0002838X22001095.pdf1-s2.0-S0002838X22001095.pdf
1-s2.0-S0002838X22001095.pdf
 
Coughlin_IFT Webinar_Caffeine Safety_November 2013
Coughlin_IFT Webinar_Caffeine Safety_November 2013Coughlin_IFT Webinar_Caffeine Safety_November 2013
Coughlin_IFT Webinar_Caffeine Safety_November 2013
 
Mintel_Kiwi_for_Irritable_Bowel_Syndrome_IBS
Mintel_Kiwi_for_Irritable_Bowel_Syndrome_IBSMintel_Kiwi_for_Irritable_Bowel_Syndrome_IBS
Mintel_Kiwi_for_Irritable_Bowel_Syndrome_IBS
 
White Lies
White LiesWhite Lies
White Lies
 
Nutraceutical ppt.
Nutraceutical ppt.Nutraceutical ppt.
Nutraceutical ppt.
 
Dancing: Alternative Therapies
Dancing: Alternative TherapiesDancing: Alternative Therapies
Dancing: Alternative Therapies
 
An Analysis Of A Few Diets, Worldwide
An Analysis Of A Few Diets, WorldwideAn Analysis Of A Few Diets, Worldwide
An Analysis Of A Few Diets, Worldwide
 

Mais de Asian Food Regulation Information Service

Interpretation of Administrative Measure on Health Food Registration Filing, ...
Interpretation of Administrative Measure on Health Food Registration Filing, ...Interpretation of Administrative Measure on Health Food Registration Filing, ...
Interpretation of Administrative Measure on Health Food Registration Filing, ...Asian Food Regulation Information Service
 

Mais de Asian Food Regulation Information Service (20)

Hong kong Dietary Guideline for Adults
Hong kong Dietary Guideline for AdultsHong kong Dietary Guideline for Adults
Hong kong Dietary Guideline for Adults
 
Wine Tourism
Wine TourismWine Tourism
Wine Tourism
 
Food Tourism
Food TourismFood Tourism
Food Tourism
 
Trends and Issues in Tourism and Hospitality
Trends and Issues in Tourism and HospitalityTrends and Issues in Tourism and Hospitality
Trends and Issues in Tourism and Hospitality
 
Vertical Farming inforgraphic
Vertical Farming inforgraphicVertical Farming inforgraphic
Vertical Farming inforgraphic
 
Interpretation of Administrative Measure on Health Food Registration Filing, ...
Interpretation of Administrative Measure on Health Food Registration Filing, ...Interpretation of Administrative Measure on Health Food Registration Filing, ...
Interpretation of Administrative Measure on Health Food Registration Filing, ...
 
Food Allergens
Food AllergensFood Allergens
Food Allergens
 
Food Labelling Regulations and Challenges in ASEAN
Food Labelling Regulations and Challenges in ASEANFood Labelling Regulations and Challenges in ASEAN
Food Labelling Regulations and Challenges in ASEAN
 
Developing a Functional Food Product - Part 2
Developing a Functional Food Product - Part 2Developing a Functional Food Product - Part 2
Developing a Functional Food Product - Part 2
 
Developing a Functional Food Product - Part 1
Developing a Functional Food Product - Part 1Developing a Functional Food Product - Part 1
Developing a Functional Food Product - Part 1
 
Food Safety Audit and Assessment
Food Safety Audit and AssessmentFood Safety Audit and Assessment
Food Safety Audit and Assessment
 
Meeting the Food Traceability Challenge
Meeting the Food Traceability ChallengeMeeting the Food Traceability Challenge
Meeting the Food Traceability Challenge
 
Cold Chain Management
Cold Chain ManagementCold Chain Management
Cold Chain Management
 
Strengthening Regulation of Recycling of Waste Cooking Oils
Strengthening Regulation of Recycling of Waste Cooking OilsStrengthening Regulation of Recycling of Waste Cooking Oils
Strengthening Regulation of Recycling of Waste Cooking Oils
 
Revision of Drinking Water Quality Standards in Japan
Revision of Drinking Water Quality Standards in JapanRevision of Drinking Water Quality Standards in Japan
Revision of Drinking Water Quality Standards in Japan
 
Food Regulations in Indonesia
Food Regulations in IndonesiaFood Regulations in Indonesia
Food Regulations in Indonesia
 
Regulatory Perspectives on GM Food in Indonesia
Regulatory Perspectives on GM Food in IndonesiaRegulatory Perspectives on GM Food in Indonesia
Regulatory Perspectives on GM Food in Indonesia
 
Veterinary Drug Control - Pakistan
Veterinary Drug Control - PakistanVeterinary Drug Control - Pakistan
Veterinary Drug Control - Pakistan
 
Animal Quarantine and Certification Services
Animal Quarantine and Certification ServicesAnimal Quarantine and Certification Services
Animal Quarantine and Certification Services
 
Improving the Effectiveness of Online Advertising
Improving the Effectiveness of Online AdvertisingImproving the Effectiveness of Online Advertising
Improving the Effectiveness of Online Advertising
 

Último

Ultra structure and life cycle of Plasmodium.pptx
Ultra structure and life cycle of Plasmodium.pptxUltra structure and life cycle of Plasmodium.pptx
Ultra structure and life cycle of Plasmodium.pptxDr. Asif Anas
 
Clinical Pharmacy Introduction to Clinical Pharmacy, Concept of clinical pptx
Clinical Pharmacy  Introduction to Clinical Pharmacy, Concept of clinical pptxClinical Pharmacy  Introduction to Clinical Pharmacy, Concept of clinical pptx
Clinical Pharmacy Introduction to Clinical Pharmacy, Concept of clinical pptxraviapr7
 
In - Vivo and In - Vitro Correlation.pptx
In - Vivo and In - Vitro Correlation.pptxIn - Vivo and In - Vitro Correlation.pptx
In - Vivo and In - Vitro Correlation.pptxAditiChauhan701637
 
The basics of sentences session 10pptx.pptx
The basics of sentences session 10pptx.pptxThe basics of sentences session 10pptx.pptx
The basics of sentences session 10pptx.pptxheathfieldcps1
 
General views of Histopathology and step
General views of Histopathology and stepGeneral views of Histopathology and step
General views of Histopathology and stepobaje godwin sunday
 
Practical Research 1: Lesson 8 Writing the Thesis Statement.pptx
Practical Research 1: Lesson 8 Writing the Thesis Statement.pptxPractical Research 1: Lesson 8 Writing the Thesis Statement.pptx
Practical Research 1: Lesson 8 Writing the Thesis Statement.pptxKatherine Villaluna
 
How to Manage Cross-Selling in Odoo 17 Sales
How to Manage Cross-Selling in Odoo 17 SalesHow to Manage Cross-Selling in Odoo 17 Sales
How to Manage Cross-Selling in Odoo 17 SalesCeline George
 
How to Use api.constrains ( ) in Odoo 17
How to Use api.constrains ( ) in Odoo 17How to Use api.constrains ( ) in Odoo 17
How to Use api.constrains ( ) in Odoo 17Celine George
 
What is the Future of QuickBooks DeskTop?
What is the Future of QuickBooks DeskTop?What is the Future of QuickBooks DeskTop?
What is the Future of QuickBooks DeskTop?TechSoup
 
UKCGE Parental Leave Discussion March 2024
UKCGE Parental Leave Discussion March 2024UKCGE Parental Leave Discussion March 2024
UKCGE Parental Leave Discussion March 2024UKCGE
 
HED Office Sohayok Exam Question Solution 2023.pdf
HED Office Sohayok Exam Question Solution 2023.pdfHED Office Sohayok Exam Question Solution 2023.pdf
HED Office Sohayok Exam Question Solution 2023.pdfMohonDas
 
The Stolen Bacillus by Herbert George Wells
The Stolen Bacillus by Herbert George WellsThe Stolen Bacillus by Herbert George Wells
The Stolen Bacillus by Herbert George WellsEugene Lysak
 
Prescribed medication order and communication skills.pptx
Prescribed medication order and communication skills.pptxPrescribed medication order and communication skills.pptx
Prescribed medication order and communication skills.pptxraviapr7
 
Easter in the USA presentation by Chloe.
Easter in the USA presentation by Chloe.Easter in the USA presentation by Chloe.
Easter in the USA presentation by Chloe.EnglishCEIPdeSigeiro
 
AUDIENCE THEORY -- FANDOM -- JENKINS.pptx
AUDIENCE THEORY -- FANDOM -- JENKINS.pptxAUDIENCE THEORY -- FANDOM -- JENKINS.pptx
AUDIENCE THEORY -- FANDOM -- JENKINS.pptxiammrhaywood
 
Practical Research 1 Lesson 9 Scope and delimitation.pptx
Practical Research 1 Lesson 9 Scope and delimitation.pptxPractical Research 1 Lesson 9 Scope and delimitation.pptx
Practical Research 1 Lesson 9 Scope and delimitation.pptxKatherine Villaluna
 
Maximizing Impact_ Nonprofit Website Planning, Budgeting, and Design.pdf
Maximizing Impact_ Nonprofit Website Planning, Budgeting, and Design.pdfMaximizing Impact_ Nonprofit Website Planning, Budgeting, and Design.pdf
Maximizing Impact_ Nonprofit Website Planning, Budgeting, and Design.pdfTechSoup
 
PISA-VET launch_El Iza Mohamedou_19 March 2024.pptx
PISA-VET launch_El Iza Mohamedou_19 March 2024.pptxPISA-VET launch_El Iza Mohamedou_19 March 2024.pptx
PISA-VET launch_El Iza Mohamedou_19 March 2024.pptxEduSkills OECD
 

Último (20)

Ultra structure and life cycle of Plasmodium.pptx
Ultra structure and life cycle of Plasmodium.pptxUltra structure and life cycle of Plasmodium.pptx
Ultra structure and life cycle of Plasmodium.pptx
 
Clinical Pharmacy Introduction to Clinical Pharmacy, Concept of clinical pptx
Clinical Pharmacy  Introduction to Clinical Pharmacy, Concept of clinical pptxClinical Pharmacy  Introduction to Clinical Pharmacy, Concept of clinical pptx
Clinical Pharmacy Introduction to Clinical Pharmacy, Concept of clinical pptx
 
In - Vivo and In - Vitro Correlation.pptx
In - Vivo and In - Vitro Correlation.pptxIn - Vivo and In - Vitro Correlation.pptx
In - Vivo and In - Vitro Correlation.pptx
 
The basics of sentences session 10pptx.pptx
The basics of sentences session 10pptx.pptxThe basics of sentences session 10pptx.pptx
The basics of sentences session 10pptx.pptx
 
General views of Histopathology and step
General views of Histopathology and stepGeneral views of Histopathology and step
General views of Histopathology and step
 
Practical Research 1: Lesson 8 Writing the Thesis Statement.pptx
Practical Research 1: Lesson 8 Writing the Thesis Statement.pptxPractical Research 1: Lesson 8 Writing the Thesis Statement.pptx
Practical Research 1: Lesson 8 Writing the Thesis Statement.pptx
 
How to Manage Cross-Selling in Odoo 17 Sales
How to Manage Cross-Selling in Odoo 17 SalesHow to Manage Cross-Selling in Odoo 17 Sales
How to Manage Cross-Selling in Odoo 17 Sales
 
How to Use api.constrains ( ) in Odoo 17
How to Use api.constrains ( ) in Odoo 17How to Use api.constrains ( ) in Odoo 17
How to Use api.constrains ( ) in Odoo 17
 
What is the Future of QuickBooks DeskTop?
What is the Future of QuickBooks DeskTop?What is the Future of QuickBooks DeskTop?
What is the Future of QuickBooks DeskTop?
 
UKCGE Parental Leave Discussion March 2024
UKCGE Parental Leave Discussion March 2024UKCGE Parental Leave Discussion March 2024
UKCGE Parental Leave Discussion March 2024
 
HED Office Sohayok Exam Question Solution 2023.pdf
HED Office Sohayok Exam Question Solution 2023.pdfHED Office Sohayok Exam Question Solution 2023.pdf
HED Office Sohayok Exam Question Solution 2023.pdf
 
The Stolen Bacillus by Herbert George Wells
The Stolen Bacillus by Herbert George WellsThe Stolen Bacillus by Herbert George Wells
The Stolen Bacillus by Herbert George Wells
 
Prescribed medication order and communication skills.pptx
Prescribed medication order and communication skills.pptxPrescribed medication order and communication skills.pptx
Prescribed medication order and communication skills.pptx
 
Easter in the USA presentation by Chloe.
Easter in the USA presentation by Chloe.Easter in the USA presentation by Chloe.
Easter in the USA presentation by Chloe.
 
AUDIENCE THEORY -- FANDOM -- JENKINS.pptx
AUDIENCE THEORY -- FANDOM -- JENKINS.pptxAUDIENCE THEORY -- FANDOM -- JENKINS.pptx
AUDIENCE THEORY -- FANDOM -- JENKINS.pptx
 
Personal Resilience in Project Management 2 - TV Edit 1a.pdf
Personal Resilience in Project Management 2 - TV Edit 1a.pdfPersonal Resilience in Project Management 2 - TV Edit 1a.pdf
Personal Resilience in Project Management 2 - TV Edit 1a.pdf
 
Practical Research 1 Lesson 9 Scope and delimitation.pptx
Practical Research 1 Lesson 9 Scope and delimitation.pptxPractical Research 1 Lesson 9 Scope and delimitation.pptx
Practical Research 1 Lesson 9 Scope and delimitation.pptx
 
Maximizing Impact_ Nonprofit Website Planning, Budgeting, and Design.pdf
Maximizing Impact_ Nonprofit Website Planning, Budgeting, and Design.pdfMaximizing Impact_ Nonprofit Website Planning, Budgeting, and Design.pdf
Maximizing Impact_ Nonprofit Website Planning, Budgeting, and Design.pdf
 
PISA-VET launch_El Iza Mohamedou_19 March 2024.pptx
PISA-VET launch_El Iza Mohamedou_19 March 2024.pptxPISA-VET launch_El Iza Mohamedou_19 March 2024.pptx
PISA-VET launch_El Iza Mohamedou_19 March 2024.pptx
 
Finals of Kant get Marx 2.0 : a general politics quiz
Finals of Kant get Marx 2.0 : a general politics quizFinals of Kant get Marx 2.0 : a general politics quiz
Finals of Kant get Marx 2.0 : a general politics quiz
 

Nutrition Labeling & Claims EU 2012

  • 1. ILSI SEA Region Nutrition Labeling Seminar, Thailand, August 2012 (www.ilsi.org/SEA _Region)
  • 2. Updates on Nutrition Labelling and Claims Regulation in Europe Sean (JJ) Strain President, The Nutrition Society Professor of Human Nutrition and Director of the Northern Ireland Centre for Food & Health (UK) jj.strain@ulster.ac.uk
  • 3. Updates on Nutrition Labelling and Claims Regulation in Europe • General considerations • Weighing the evidence
  • 4. Updates on Nutrition Labelling and Claims Regulation in Europe • General considerations • Weighing the evidence
  • 5. ‘Taco Bell Nineteen-year-old Alicia Vargas of Yuma, AZ, avoids getting pregnant with a delicious ContraceptiMelt’ Source: The Onion, March 12, 1997 http://www.theonion.com/content/node/29938/print/
  • 6. What EFSA cannot do • Be responsible for food safety legislation • Take charge of food safety/quality controls, labelling or other such issues • Act as a substitute for national authorities
  • 7. NDA Panel & Working Groups Safety and suitability Safety Safety Infant Formulae Novel Foods Upper Levels NDA Panel Dietary Reference 21 Members Values Food Allergy Claims Scientific advice Safety Evaluation of scientific substantiation Supported by the EFSA Nutrition Unit
  • 8. Regulation (EC) No 1924/2006 of the European Parliament and of the Council • Article 5: General conditions: The use of nutrition and health claims shall only be permitted if the following conditions are fulfilled: (a) the presence, absence or reduced content in a food or category of food of a nutrient or other substance in respect of which the claim is made has been shown to have a beneficial nutritional or physiological effect claimed as established by generally accepted scientific evidence
  • 9. What EFSA can do • Recital 17: A claim should be scientifically substantiated by taking into account the totality of the available scientific evidence, and by weighing the evidence • Recital 23: Health claims should only be authorised for use in the Community after a scientific assessment of the highest possible standard. In order to ensure harmonised scientific assessment of these claims, the European Food Safety Authority should carry out such assessments. • Article 6: Nutrition and health claims shall be based on and substantiated by generally accepted scientific evidence
  • 10. What EFSA was expected to do • Recital 26: Health claims other than those referring to the reduction of disease risk and to children’s development and health, based on generally accepted scientific evidence, should undergo a different type of assessment and authorisation. It is therefore necessary to adopt a Community list of such permitted claims after consulting the European Food Safety Authority.
  • 11. Health claims Article 13 Article 14 a) Growth & development & Based on newly Reduction of disease functions of body developed risk (risk factor scientific reduction) and claims b) Psychological & behavioural referring to children’s evidence or functions development and requesting health c) Slimming or weight control or protection of reduction in sense of hunger or proprietary increase in sense of satiety or data reduction of available energy Based on generally accepted Article 13.5 scientific evidence Article 13.1
  • 12. Advantages of Submission by Dossier Allows: 1. Complete characterisation of the food which is the subject of the claim 2. Full description of the health relationship claimed and any underlying hypotheses 3. Clear indication of decision tree for collecting the pertinent studies 4. Case to be made for substantiation on the basis of the pertinent studies 5. Dialogue between Applicant and EFSA in order to clarify any issues arising
  • 13. ID Health Food or Food constituent Proposed wording Relationship 561 Xylitol-sweetened chewing Ears Xylitol is good for the health of gum ears. Maintains good health of the ears. Conditions of use - Chewing gums with 65% xylitol. 2 pieces 3-5 times per day. The product may not contain sugars capable of fermentation and the requirements for other Finnish Dental Association recommendations must be fulfilled.
  • 14. The Citation Newsletter Ezekiel 27.17 The Old Testament In: The Holy Bible. ID 3668: “Panax ginseng (common name: Asian, Korean ginseng)” and “cognitive performance” Full text: Judah and Israel gave you their finest wheat, fancy figs, honey, olive oil, and spices in exchange for your merchandise. Beck, L, The complete idiot’s guide to total nutrition for Canadians. Hellmann J, 2006. Data in preparation – confidential. Intervention (n = 46). Study finished in May 2006 Anonymous, 2007. Andenne Omega3 – Menu. Not published intervention trial, realized from January to June 2007, Andenne, Belgium Tea association, 2003. Classical drink as trend: tea consumption stable at a high level. German tea industry satisfied with financial year. Press release
  • 15. The Clarification Newsletter Food: Before: “Vitamins, minerals, lysine and/or taurine” After: “Combination of different vitamins and minerals, lysine and/or argine and/or taurine” Before: “Carbohydrates from pasta” After: “Pasta from different kinds of cereal grains, e.g. durum wheat, wheat, barley, oat and rye. Except autoclaved products” Before: “Green tea extract (Camelia sinesis) After: “Green tea extract (Camelia senesis); People have always been plagued by high blood pressure, which is triggered by the loss of elasticity in the… Before: “Antioxidants” After: “Antioxidants (Source of antioxidants from the list of health claims given a positive opinion by EFSA)”
  • 16. ID Food or Food Health Relationship Proposed wording constituent 561 Xylitol- Ears Xylitol is good for the health of sweetened Clarification provided ears. chewing gum Ears Clarification: Inhibits the Maintains good health of the absorption of cholesterol. ears. Heart Health and artery health Conditions of use - Chewing gums with 65% xylitol. 2 pieces 3-5 times per day. The product may not contain sugars capable of fermentation and the requirements for other Finnish Dental Association recommendations must be fulfilled.
  • 17. Article 13.1 is best suited to essential nutrient claims 1. All essential nutrients are sufficiently characterised. 2. Health relationships are generally straight forward and well known. 3. In general, all have clear biochemical and physiological (functional) roles which often can be linked to clinical symptoms of deficiency and it is relatively simple to establish causality.
  • 18. Calcium and nerve function • Well established science • But where is the evidence?
  • 21. How do we weigh sick cows?
  • 22. Health claims Article 13 Article 14 a) Growth & development & Based on newly Reduction of disease functions of body developed risk (risk factor scientific reduction) and claims b) Psychological & behavioural referring to children’s evidence or functions development and requesting health c) Slimming or weight control or protection of reduction in sense of hunger or proprietary increase in sense of satiety or data reduction of available energy Based on generally accepted Article 13.5 scientific evidence Article 13.1
  • 23. Where did it all go wrong? EC COM (2003) 0424 • Being based on long-established and non- controversial science, health claims that describe the role of a nutrient or other substance in growth, development and normal physiological functions of the body shall undergo a different type of assessment…. EC 1924/2006 • Based on generally accepted scientific evidence….
  • 24. Health claims Article 13 Article 14 a) Growth & development & Based on newly Reduction of disease functions of body developed risk (risk factor scientific reduction) and claims b) Psychological & behavioural referring to children’s evidence or functions development and requesting health c) Slimming or weight control or protection of reduction in sense of hunger or proprietary increase in sense of satiety or data reduction of available energy Based on generally accepted Article 13.5 scientific evidence Article 13.1
  • 25. Updates on Nutrition Labelling and Claims Regulation in Europe • General considerations • Weighing the evidence
  • 26. Points to consider in determining whether a study is pertinent to the claim: 1. Human dietary studies are central for the substantiation of the claim. 2. Does the study address the food constituent which has been characterised in the application? 3. Does the study address endpoints of relevance to the health relationship as defined in the application? 4. Is the study in the target population as indicated in the application or could it be extrapolated to the target population?
  • 27. Points to consider in determining whether a study is pertinent to the claim: 5. Is the dosage and/or food matrix relevant to the proposed condition of use as defined in the application? 6. Are supportive studies in animals or in vitro relevant for the claimed effect? 7. The human studies meeting all of the criteria outlined in 1-5 together with the relevant supportive studies identified in 6 should be regarded as the pertinent studies on which to base the substantiation. 8. If the opinion might be favourable from the references provided a check should be performed to confirm whether the references reflect the totality of the evidence in the literature.
  • 28. Five conditions of causality • Ability to manipulate the effect • Specificity of cause and effect • Consistent associations with outcome measures • Dose response relationship • Plausible biological mechanism
  • 29. Concluding on a cause and effect relationship • A cause and effect relationship has been established between the consumption of the food and the beneficial physiological effect • A cause and effect relationship has not been established between the consumption of the food and the beneficial physiological effect • The evidence provided is insufficient to establish a cause and effect relationship between the consumption of the food and the beneficial physiological effect
  • 30. Conclusion on calcium and neurotransmission • The Panel considers that a cause and effect relationship has been established between calcium and normal muscle function and neurotransmission. However, the evidence provided does not establish that inadequate intake of calcium leading to impaired muscle function and neurotransmission occurs in the general EU population.
  • 31. EFSA health claims evaluation status (31 July 2012) In Under Claim type Received Withdrawn Adopted Validation progress 53 opinions Children (Article 14) 220 110 covering 60 0* 50 applications Disease risk reduction 32 opinions 58 23 covering 33 0** 2 (Article 14) applications New science/ proprietary 61 opinions 103 17 covering 62 18*** 6 (Article 13.5) applications Conditions of use (Article 2 0 2 0 0 19) 148 Total applications 383 150 opinions covering 18 58 157 applications Article 13.1 list of health 2849 1548 4728 331 0 claims (2776 published) (on hold) * 0 in clock stop ** 0 in clock stop *** 0 in clock stop
  • 32. Examples of positive health claims evaluations (> 200) Claim Food/constituent LDL cholesterol and risk of heart Phytosterols, oat -glucan, replacing disease saturated fats by unsaturated fats Dental plaque and risk of caries Sugar-free chewing gum Body weight Meal replacements, VLCD Bowel function Cereal fibres (wheat, barley, oat, rye) Blood glucose after meals Pectins, guar gum, resistant starch, sugar replacers Blood pressure potassium, reduced sodium Lactose digestion Yoghurt live bacterial cultures Platelet aggregation Water sol. tomato conc.