TeRiFiQ Conference
Reducing salt, fat and sugar in everyday foods – Results from TeRiFiQ EU project and opportunities for food industry
27 October 2015 ♦ Milan EXPO, Italy
A Global Perspective on Food Health Claims Nutrasource
On Wednesday, August 21st, Pulse Canada hosted an expert panel workshop in Toronto on the potential for a health claim related to Lentils and Post-prandial Glycaemia in Toronto. Invited delegates to the workshop included over 30 representatives from the pulse industry, food industry, academia as well as and regulatory experts. The purpose of the workshop was to provide a forum in which to discuss a systematic literature review that was conducted in 2012 by Nutrasource Diagnostics Inc (NDI) with respect to achieving a health claim related to lentils and short term blood sugar control in Canada, the US or the EU.
Krista Coventry from NDI presented a background on the regulatory frameworks in Canada, the US, the EU and Australia/New Zealand.
Submitting a food product to obtain a health claim is a very complex process.
Institut Kurz is specialized in preparation of dossiers for Health Claim applications according to EU-Ordinance 1924.
If you want your food product to have a health claim, Institut Kurz does it for you.
Contact us: info@institut-kurz.com
www.institut-kurz.com
A Global Perspective on Food Health Claims Nutrasource
On Wednesday, August 21st, Pulse Canada hosted an expert panel workshop in Toronto on the potential for a health claim related to Lentils and Post-prandial Glycaemia in Toronto. Invited delegates to the workshop included over 30 representatives from the pulse industry, food industry, academia as well as and regulatory experts. The purpose of the workshop was to provide a forum in which to discuss a systematic literature review that was conducted in 2012 by Nutrasource Diagnostics Inc (NDI) with respect to achieving a health claim related to lentils and short term blood sugar control in Canada, the US or the EU.
Krista Coventry from NDI presented a background on the regulatory frameworks in Canada, the US, the EU and Australia/New Zealand.
Submitting a food product to obtain a health claim is a very complex process.
Institut Kurz is specialized in preparation of dossiers for Health Claim applications according to EU-Ordinance 1924.
If you want your food product to have a health claim, Institut Kurz does it for you.
Contact us: info@institut-kurz.com
www.institut-kurz.com
Presentation to the San Diego Regulatory Affairs Network (SDRAN) RAC Review course; August 2011; covering:
♦ Basics
♦ New Dietary Ingredients
♦ Claims Allowed
♦ GMPs and Other Regulatory Requirements
♦ Adverse Events
Analyzing the Dietary Supplement Health and Education Act and other related r...AJHSSR Journal
The research introduces the policy of Dietary Supplement Health and Education Act (DSHEA) and relevant regulations and backgrounds with quantitative data analysis. Studying case studies of Dietary Supplement Health Educational Act (DSHEA) might address Food and Drug Administration (FDA) accountabilities and improvements.
The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments.
The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.
The FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs.
These include sanitation requirements on interstate travel and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction.
FSSAI REGULATIONS FOR THE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN I...Swapnil Fernandes
- Nutraceutical market has shown steady increase in the last decade.
- The import, manufacture and marketing regulations for nutraceuticals in India have been streamlined with the updation of the FSSAI regulations 2016.
- RDA’s are a collection of values to express a person's nutrient need based on their life stage & gender.
- The RDA recommendations for the Indian population has been provided by the ICMR on the basis of scientific studies and subsequent data generated.
IN THIS SUMMARY
The United States Food and Drug Administration (FDA) has significant reach in the American economy, ranging from medicines and medical devices to items on the grocery store shelves. Since its inception in 1906, the agency has faced a variety of technical and political challenges. Looking ahead, the FDA faces many new demands that could enlarge the agency’s already expansive mandate. New responsibilities may include the cost of medicine, consumers’ pursuit of perfection through drugs, consumer lifestyles, tobacco, and counterterrorism. As the nature of public health changes over time, it is inevitable that the FDA’s scope and responsibilities will change as well. In Inside the FDA, Fran Hawthorne explains the history of the FDA, how its processes work, and what the future may hold for this government agency.
SUBSCRIBE TODAY
http://www.bizsum.com/summaries/inside-fda
Presentation to the San Diego Regulatory Affairs Network (SDRAN) RAC Review course; August 2011; covering:
♦ Basics
♦ New Dietary Ingredients
♦ Claims Allowed
♦ GMPs and Other Regulatory Requirements
♦ Adverse Events
Analyzing the Dietary Supplement Health and Education Act and other related r...AJHSSR Journal
The research introduces the policy of Dietary Supplement Health and Education Act (DSHEA) and relevant regulations and backgrounds with quantitative data analysis. Studying case studies of Dietary Supplement Health Educational Act (DSHEA) might address Food and Drug Administration (FDA) accountabilities and improvements.
The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments.
The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.
The FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs.
These include sanitation requirements on interstate travel and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction.
FSSAI REGULATIONS FOR THE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN I...Swapnil Fernandes
- Nutraceutical market has shown steady increase in the last decade.
- The import, manufacture and marketing regulations for nutraceuticals in India have been streamlined with the updation of the FSSAI regulations 2016.
- RDA’s are a collection of values to express a person's nutrient need based on their life stage & gender.
- The RDA recommendations for the Indian population has been provided by the ICMR on the basis of scientific studies and subsequent data generated.
IN THIS SUMMARY
The United States Food and Drug Administration (FDA) has significant reach in the American economy, ranging from medicines and medical devices to items on the grocery store shelves. Since its inception in 1906, the agency has faced a variety of technical and political challenges. Looking ahead, the FDA faces many new demands that could enlarge the agency’s already expansive mandate. New responsibilities may include the cost of medicine, consumers’ pursuit of perfection through drugs, consumer lifestyles, tobacco, and counterterrorism. As the nature of public health changes over time, it is inevitable that the FDA’s scope and responsibilities will change as well. In Inside the FDA, Fran Hawthorne explains the history of the FDA, how its processes work, and what the future may hold for this government agency.
SUBSCRIBE TODAY
http://www.bizsum.com/summaries/inside-fda
In Spring 2013, we are on the precipice of dramatic, disruptive change in the health field that offers an unprecedented opportunity and challenge to transform health care and population health.
We know that traditional public health approaches along with more and better health care are not enough to improve health outcomes, equity, and cost. We must also:
- implement sustainable, fundamental "upstream" changes that address the root causes of disease and disability; and
- transform the way we deliver health care to ensure access to quality, affordable health care for all.
Enjoy this Bright Spot presentation from Lucia Sayre of Health Care Without Harm, which was presented at the 2013 Annual Leadership Conference, co-sponsored by the Center for Health Leadership (CHL) and the California Pacific Public Health Training Center (CALPACT) at UC Berkeley's School of Public Health.
To learn more about this event, please visit:
http://calpact.org/index.php/en/events/leadership-conference
Learn more about CALPACT:
http://calpact.org/
Learn more about the CHL:
http://chl.berkeley.edu/
Updates on Nutrition Labeling and Claims Regulations in Thailand by Tipvon Parinyasiri, Director of Bureau of Food, Thai Food and Drug Administration.
Presented at the 9th Seminar on Nutrition Labeling, Claims and Communication Strategies, August 4 ~ 5 August, Manila, Philippines.
Updates on Nutrition Labeling and Claims Regulations in Malaysia by Norrani Eksan, Food Safety and Quality Division, Ministry of Health Malaysia
Presented at the 9th Seminar on Nutrition Labeling, Claims and Communication Strategies, August 4 ~ 5 August, Manila, Philippines.
Anlässlich des 10-jährigen Bestehens der AGES und der 5-jährigen Kooperation mit dem deutschen Bundesinstitut für Risikobewertung (BfR) fanden zwei Spezialveranstaltungen zum Thema Nahrungsergänzungsmittel (NEM) statt, bei der die bisher umfassendste Erhebung zum Thema im deutschen Sprachraum exklusiv präsentiert wurde. Risiken und Nutzen von NEM wurden aus Sicht der Lebensmittel- & Arzneimittelsicherheit, Risikobewertung & Risikokommunikation, die den Verbraucherinteressen gerecht wird, betrachtet. Anbei die Dokumentation der beiden Fachtagungen mit den Vorträgen und Präsentationen:
1. AGES-BfR-Forum "Nahrungsergänzungsmittel: Nutzen und Risiko", 30. Mai 2012 (AGES, Wien)
http://www.ages.at/ages/ages-akademie/stakeholderveranstaltungen/wien-nahrungsergaenzungsmittel/
14. BfR-Forum Verbraucherschutz Nahrungsergänzungsmittel "Notwendig, Luxus oder gesundheitliches Risiko?", 10./11. Oktober 2012 (BfR, Berlin)
http://www.bfr.bund.de/de/veranstaltung/14__bfr_forum_verbraucherschutz__nahrungsergaenzungsmittel_-129397.html
This is concise comparative analysis of health food drinks in India. The deck contains briefs on health food and Health food drinks followed by analysis of major HFD Brands in India and their marketing approaches. The deck concludes with challenges, opportunities and key success factors in the Indian Health Food drinks Industry.
Bringing Your Supplements, Medical Foods and Pharmaceutical Drugs to MarketNutrcapnetwork
With companies in nutrition and health & wellness making crucial product development and marketing decisions, a clear picture of regulatory tracks for supplements, medical foods and drugs is essential. Co-hosted by Nutritional Capital Network and Todd Harrison, Co-Chair, Food, Dietary Supplements and Cosmetics Practice of Venable LLP, NCN's law firm sponsor.
Over bewezen en onbewezen gezondheidsclaims, en over de echte risico’s van onze voeding.
Deze avond vertelt prof. Verhagen over zin en onzin in onze voeding. “Gelukkig is nu in de wet geregeld dat gezondheidsclaims op voedingsmiddelen wetenschappelijk bewezen moeten zijn. Veel onzinclaims zullen hierdoor op termijn verdwijnen. De schappen zullen er straks weliswaar anders uitzien, maar niet leger worden.”
En hij vertelt dat onze voeding nog nooit zo veilig is geweest. “De echte gezondheidsrisico’s van onze voeding zit niet in allerlei chemische stofjes, maar in te veel eten en vooral in verkeerd eten. Meer nog: een snufje risico hoort er bij. Een beetje risico kan wellicht nodig zijn net als op andere terreinen.“
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014R0536&from=EN
the ppt describes in detail the translational research and path of the drug from lab to bed side, CONSORT guidelines, DCGI guidelines, CTR-I, the GCP principles, medical ethics, sample size estimation for RCT, RCT designs including cross over design and factorial design, Randomized permuted blocks, blinding and matching.
Dr. Piotr Iwanowski - 6th Clinical Research ConferenceStarttech Ventures
Ομιλία - Παρουσίαση: Dr. Piotr Iwanowski, National Board Member, Polish Association for Good Clinical Practice (GCPpl) & Associate VP Clinical Research Europe, Wockhardt Bio AG
Τίτλος Παρουσίασης: «The Five Things Changing the Landscape of Clinical Research»
At our second Annual Health Law Year in P/Review event, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine welcomed experts discussing major developments during 2013 and what to watch out for in areas including the Affordable Care Act, medical malpractice, FDA regulatory policy, abortion, contraception, intellectual property in the life sciences industry, public health policy, and human subjects research.
The secrets behind "reduced-in" pizza (PLEASURE project) by Alain Le Bail, ON...Yohan Lecuona
TeRiFiQ Conference
Reducing salt, fat and sugar in everyday foods – Results from TeRiFiQ EU project and opportunities for food industry
27 October 2015 ♦ Milan EXPO, Italy
Flavour release and perception in reformulated foods -towards a better unders...Yohan Lecuona
TeRiFiQ Conference
Reducing salt, fat and sugar in everyday foods – Results from TeRiFiQ EU project and opportunities for food industry
27 October 2015 ♦ Milan EXPO, Italy
Less fat, salt and sugar in sauces by Peter Wilde, IFRYohan Lecuona
TeRiFiQ Conference
Reducing salt, fat and sugar in everyday foods – Results from TeRiFiQ EU project and opportunities for food industry
27 October 2015 ♦ Milan EXPO, Italy
Less fat and sugar in muffins and madeleines by Markus Stieger, WURYohan Lecuona
TeRiFiQ Conference
Reducing salt, fat and sugar in everyday foods – Results from TeRiFiQ EU project and opportunities for food industry
27 October 2015 ♦ Milan EXPO, Italy
Less fat and sodium in sausages by Rune Rødbotten, NOFIMAYohan Lecuona
TeRiFiQ Conference
Reducing salt, fat and sugar in everyday foods – Results from TeRiFiQ EU project and opportunities for food industry
27 October 2015 ♦ Milan EXPO, Italy
Less sodium content and better fat in cheeses by Jean-René Kerjean, ACTALIAYohan Lecuona
TeRiFiQ Conference
Reducing salt, fat and sugar in everyday foods – Results from TeRiFiQ EU project and opportunities for food industry
27 October 2015 ♦ Milan EXPO, Italy
Introduction to TeRiFiQ by Christian Salles, INRAYohan Lecuona
TeRiFiQ Conference
Reducing salt, fat and sugar in everyday foods – Results from TeRiFiQ EU project and opportunities for food industry
27 October 2015 ♦ Milan EXPO, Italy
TeRiFiQ: Reducing Salt, Fat & Sugar in Everyday Foods.
Collaborative Project coordinated by INRA and funded by the European Union's Seventh Framework Programme Under Grant Agreement nr. 289397.
Roti Bank Hyderabad: A Beacon of Hope and NourishmentRoti Bank
One of the top cities of India, Hyderabad is the capital of Telangana and home to some of the biggest companies. But the other aspect of the city is a huge chunk of population that is even deprived of the food and shelter. There are many people in Hyderabad that are not having access to
At Taste Of Middle East, we believe that food is not just about satisfying hunger, it's about experiencing different cultures and traditions. Our restaurant concept is based on selecting famous dishes from Iran, Turkey, Afghanistan, and other Arabic countries to give our customers an authentic taste of the Middle East
Ang Chong Yi Navigating Singaporean Flavors: A Journey from Cultural Heritage...Ang Chong Yi
In the heart of Singapore, where tradition meets modernity, He embarks on a culinary adventure that transcends borders. His mission? Ang Chong Yi Exploring the Cultural Heritage and Identity in Singaporean Cuisine. To explore the rich tapestry of flavours that define Singaporean cuisine while embracing innovative plant-based approaches. Join us as we follow his footsteps through bustling markets, hidden hawker stalls, and vibrant street corners.
Ang Chong Yi Navigating Singaporean Flavors: A Journey from Cultural Heritage...
Health claim dossier: opportunities for SMEs and lessons learnt by Alfonso Siani, EFSA
1. Health claim dossier: opportunities for SMEs
and lessons learnt
Alfonso Siani, MD
Institute of Food Sciences, CNR
Chair, EFSA Standing Working group on Claims
2. 2
Claims substantiated by
Reg. (EC) No 1924/2006
“Health claims should only be authorised for use in the Community
after a scientific assessment of the highest possible standard”
MAIN CRITERIA FOR HEALTH CLAIMS
Reg. (EC) No 1924/2006
“generally accepted scientific evidence”
“totality of the available scientific data”
“weighing the evidence”
3. 3
Reg. (EC) No 1924/2006
“In order to ensure a harmonised scientific assessment of
these claims, EFSA should carry out such assessments”
NDA Panel applies a single standard of evidence for
substantiation of all health claims
NDA Panel adopts scientific opinions
EFSA’S ROLE
Reg. (EC) No 1924/2006
AUTHORISATION: by Commission/Member States,
European Parliament scrutiny
EU Register of Claims (http://ec.europa.eu/nuhclaims/)
4. 4
HEALTH CLAIMS
Regulation (EC) 1924/2006
Art.13.1
Generally
accepted
scientific
evidence
Art.13.5
Newly developed
scientific data /
proprietary data
Art.14
Reduction of
disease
Risk
Children’s
development &
health
List Claims Applications
5. 5
subjects with a disease cannot be the target population for
health claims made on food
function claims cannot refer to a disease
disease risk reduction claims cannot refer to the reduction of
the risk of a disease, but should refer to the reduction of a risk
factor for disease
The NDA Panel considers that the target population for health
claims made on food is the general population or
subgroups thereof defined on the basis of age, gender,
physiological conditions and/or lifestyle (e.g. children, men,
post-menopausal women, adults performing endurance
exercise)
REGULATORY REQUIREMENTS
Main title
6. 6
Human data are central
Claim definition
1. Is the food/constituent defined and characterised?
2. Is the claimed effect defined and is it a beneficial
physiological effect, and can it be measured in vivo in
human?
Substantiation
3. Is a cause and effect relationship established between
the consumption of the food/constituent and the claimed
effect?
for the target group and under the proposed conditions
of use
SCIENTIFIC ASSESSMENT
3 main questions
Main title
7. 7
Selection/review of pertinent human studies:
central for substantiation
Review of supportive studies on biological
plausibility (e.g. mechanisms that explain the
effect of the food)
Weighing the evidence - combining the
relevant human studies + other studies to
conclude on substantiation
SCIENTIFIC ASSESSMENT
Steps
Main title
9. 9
Applications on Article 13.5 and Article 14
health claims: 460 received
Art 13.1 list: finalised except botanicals
(1548 on hold)
HEALTH CLAIMS (STATUS 22/09/2015)
10. 10
Issues arising while reviewing scientific
evidence for health claims
Delays in evaluation process
Reasons for clock stops requesting
supplementary information
(from 109 clock stop letters to applicants)
HEALTH CLAIM APPLICATIONS
11. 11
Main title
Characterisation
of the food
constituents
12%
Claimed effect &
target population
13%
Studies
submitted
for
substantiation of
claims
75%
Reasons
for clock stops
12. 12
Main title
Study
participants
8%
Study products
vs. controls
9%
Outcomes
13%
Sample
size/power
calculation
5%
Randomisation
5%
Blinding
3%
Statistics
23%
Result
reporting
14%
Others
20%
Questions on studies submitted
for substantiation of claims
13. 13
MIS-REPORTING OF STUDIES
Main title
Published papers may not accurately represent
what was done and what was the outcome
incomplete reporting, e.g. subject selection,
enrolment, randomisation, retention and drop
outs; statistical analyses
selective reporting of outcomes, subgroup
analyses – mainly favourable outcomes
reported
EFSA may request additional information from the
applicant, including full study report for key studies
14. 14
General
Preparation and presentation of applications (revised 2011)
General scientific guidance for stakeholders (public consultation
Jul-August; finalisation Dec 2015)
Specific
Gut, immune (public consultations; finalisation Dec 2015)
Bone, joints, skin, oral
Appetite, body weight, blood glucose
Antioxidants, cardiovascular
Physical performance
Neurological, psychological function
CLAIMS GUIDANCE