Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.
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...
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
Source: The Onion, March 12, 1997
http://www.theonion.com/content/node/29938/print/
‘Taco Bell
Nineteen-year-old
Alicia Va...
What EFSA cannot do
• Be responsible for food safety legislation
• Take charge of food safety/quality controls,
labelling ...
NDA Panel & Working Groups
Infant Formulae
Dietary Reference
Values
Novel Foods
Food Allergy
Claims
Upper Levels
NDA Panel...
Regulation (EC) No 1924/2006 of the
European Parliament and of the Council
• Article 5: General conditions: The use of nut...
What EFSA can do
• Recital 17: A claim should be scientifically substantiated by
taking into account the totality of the a...
What EFSA was expected to do
• Recital 26: Health claims other than those
referring to the reduction of disease risk and t...
Health claims
a) Growth & development &
functions of body
b) Psychological & behavioural
functions
c) Slimming or weight c...
Advantages of Submission by Dossier
Allows:
1. Complete characterisation of the food which is
the subject of the claim
2. ...
ID
Food or Food constituent
Health
Relationship
Proposed wording
561 Xylitol-sweetened chewing
gum
Ears Xylitol is good fo...
The Citation Newsletter
Ezekiel 27.17 The Old Testament In: The Holy Bible.
ID 3668: “Panax ginseng (common name: Asian, K...
The Clarification Newsletter
Food:
Before: “Vitamins, minerals, lysine and/or taurine”
After: “Combination of different vi...
ID
Food or Food
constituent
Health Relationship Proposed wording
561 Xylitol-
sweetened
chewing gum
Ears
Clarification pro...
Article 13.1 is best suited to essential
nutrient claims
1. All essential nutrients are sufficiently
characterised.
2. Hea...
Calcium and nerve function
• Well established science
• But where is the evidence?
Milk Fever
How do we weigh sick cows?
Health claims
a) Growth & development &
functions of body
b) Psychological & behavioural
functions
c) Slimming or weight c...
Where did it all go wrong?
EC COM (2003) 0424
• Being based on long-established and non-
controversial science, health cla...
Health claims
a) Growth & development &
functions of body
b) Psychological & behavioural
functions
c) Slimming or weight c...
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 ...
Points to consider in determining whether a
study is pertinent to the claim:
5. Is the dosage and/or food matrix relevant ...
Five conditions of causality
• Ability to manipulate the effect
• Specificity of cause and effect
• Consistent association...
Concluding on a cause and
effect relationship
• A cause and effect relationship has been established
between the consumpti...
Conclusion on calcium and
neurotransmission
• The Panel considers that a cause and effect
relationship has been establishe...
EFSA health claims evaluation status
(31 July 2012)
Claim type Received Withdrawn Adopted
In
progress
Under
Validation
Chi...
Examples of positive health claims
evaluations (> 200)
Claim Food/constituent
LDL cholesterol and risk of heart
disease
Ph...
AFRIS. AsianFoodRegulationInformationService.
We have the largest database of Asian food regulations in the world and it’s...
Update on Nutrition Labeling and Claims Regulation in EU 2012
You’ve finished this document.
Download and read it offline.
Upcoming SlideShare
Nutrition Labeling & Claims EU 2012
Next
Upcoming SlideShare
Nutrition Labeling & Claims EU 2012
Next
Download to read offline and view in fullscreen.

0

Share

Update on Nutrition Labeling and Claims Regulation in EU 2012

Download to read offline

International Life Sciences Nutrition Labeling Seminar, Thailand, August 2012

Related Audiobooks

Free with a 30 day trial from Scribd

See all
  • Be the first to like this

Update on Nutrition Labeling and Claims Regulation in EU 2012

  1. 1. ILSI SEA Region Nutrition Labeling Seminar, Thailand, August 2012 (www.ilsi.org/SEA _Region)
  2. 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. 3. Updates on Nutrition Labelling and Claims Regulation in Europe • General considerations • Weighing the evidence
  4. 4. Updates on Nutrition Labelling and Claims Regulation in Europe • General considerations • Weighing the evidence
  5. 5. Source: The Onion, March 12, 1997 http://www.theonion.com/content/node/29938/print/ ‘Taco Bell Nineteen-year-old Alicia Vargas of Yuma, AZ, avoids getting pregnant with a delicious ContraceptiMelt’
  6. 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. 7. NDA Panel & Working Groups Infant Formulae Dietary Reference Values Novel Foods Food Allergy Claims Upper Levels NDA Panel 21 Members Supported by the EFSA Nutrition Unit Safety Safety and suitability Safety SafetyScientific advice Evaluation of scientific substantiation
  8. 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. 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. 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. 11. Health claims a) Growth & development & functions of body b) Psychological & behavioural functions c) Slimming or weight control or reduction in sense of hunger or increase in sense of satiety or reduction of available energy Based on generally accepted scientific evidence Article 13.1 Based on newly developed scientific evidence or requesting protection of proprietary data Article 13.5 Reduction of disease risk (risk factor reduction) and claims referring to children’s development and health Article 13 Article 14
  12. 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. 13. ID Food or Food constituent Health Relationship Proposed wording 561 Xylitol-sweetened chewing gum Ears Xylitol is good for the health of 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. 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. 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. 16. ID Food or Food constituent Health Relationship Proposed wording 561 Xylitol- sweetened chewing gum Ears Clarification provided Ears Clarification: Inhibits the absorption of cholesterol. Heart Health and artery health Xylitol is good for the health of 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.
  17. 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. 18. Calcium and nerve function • Well established science • But where is the evidence?
  19. 19. Milk Fever
  20. 20. How do we weigh sick cows?
  21. 21. Health claims a) Growth & development & functions of body b) Psychological & behavioural functions c) Slimming or weight control or reduction in sense of hunger or increase in sense of satiety or reduction of available energy Based on generally accepted scientific evidence Article 13.1 Based on newly developed scientific evidence or requesting protection of proprietary data Article 13.5 Reduction of disease risk (risk factor reduction) and claims referring to children’s development and health Article 13 Article 14
  22. 22. 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….
  23. 23. Health claims a) Growth & development & functions of body b) Psychological & behavioural functions c) Slimming or weight control or reduction in sense of hunger or increase in sense of satiety or reduction of available energy Based on generally accepted scientific evidence Article 13.1 Based on newly developed scientific evidence or requesting protection of proprietary data Article 13.5 Reduction of disease risk (risk factor reduction) and claims referring to children’s development and health Article 13 Article 14
  24. 24. Updates on Nutrition Labelling and Claims Regulation in Europe • General considerations • Weighing the evidence
  25. 25. 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?
  26. 26. 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.
  27. 27. 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
  28. 28. 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
  29. 29. 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.
  30. 30. EFSA health claims evaluation status (31 July 2012) Claim type Received Withdrawn Adopted In progress Under Validation Children (Article 14) 220 110 53 opinions covering 60 applications 0* 50 Disease risk reduction (Article 14) 58 23 32 opinions covering 33 applications 0** 2 New science/ proprietary (Article 13.5) 103 17 61 opinions covering 62 applications 18*** 6 Conditions of use (Article 19) 2 0 2 0 0 Total applications 383 150 148 opinions covering 157 applications 18 58 Article 13.1 list of health claims 4728 331 2849 (2776 published) 0 1548 (on hold) * 0 in clock stop ** 0 in clock stop *** 0 in clock stop
  31. 31. Examples of positive health claims evaluations (> 200) Claim Food/constituent LDL cholesterol and risk of heart disease Phytosterols, oat -glucan, replacing 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.
  32. 32. AFRIS. AsianFoodRegulationInformationService. We have the largest database of Asian food regulations in the world and it’s FREE to use. We publish a range of communication services, list a very large number of food events and online educational webinars and continue to grow our Digital Library. We look forward to hearing from you soon! www.asianfoodreg.com adrienna@asianfoodreg.com

International Life Sciences Nutrition Labeling Seminar, Thailand, August 2012

Views

Total views

265

On Slideshare

0

From embeds

0

Number of embeds

1

Actions

Downloads

6

Shares

0

Comments

0

Likes

0

×