NSF certification, Standard for dietary supplementAtul Bhombe
Manufacturers, regulators and consumers look to NSF International for the development of public health standards and certification programs that help protect the world’s food, water, consumer products and environment. NSF is a global, independent organization, our standards team facilitates development of public health standards, and our service teams test, audit and certify products and services
The long awaited new novel food regulation has finally made its very welcome arrival to update and streamline the approach to gaining approval for new food and food ingredients in the EU. It’s main benefits are to clarify the scope and definitions, to introduce a centralised procedure and to introduce a notification process for “traditional foods from third countries”. Whilst it also introduces a generic “Union List”, it also allows proprietary submissions in some cases. Although the actual legal enactment is not until January 2018, there is so much to do in the meantime. January 2016 webinar now available on demand: http://www.intertek.com/knowledge-education/new-novel-food-regulation-transition-begins/
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
NSF certification, Standard for dietary supplementAtul Bhombe
Manufacturers, regulators and consumers look to NSF International for the development of public health standards and certification programs that help protect the world’s food, water, consumer products and environment. NSF is a global, independent organization, our standards team facilitates development of public health standards, and our service teams test, audit and certify products and services
The long awaited new novel food regulation has finally made its very welcome arrival to update and streamline the approach to gaining approval for new food and food ingredients in the EU. It’s main benefits are to clarify the scope and definitions, to introduce a centralised procedure and to introduce a notification process for “traditional foods from third countries”. Whilst it also introduces a generic “Union List”, it also allows proprietary submissions in some cases. Although the actual legal enactment is not until January 2018, there is so much to do in the meantime. January 2016 webinar now available on demand: http://www.intertek.com/knowledge-education/new-novel-food-regulation-transition-begins/
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
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.
REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS A GLOBALKapilKumar198
This presentation contains detailed information about the regulatory aspects of food and nutraceuticals a global prospective, which includes WHO guidelines on nutrition and NSF International.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
The recently enacted Food Safety Modernization Act is the greatest expansion of FDA’s food regulatory authority since the enactment in 1938 of the Federal Food, Drug, and Cosmetic Act. This presentation discuses the scope, impact and implementation of the Act. Presented by FDAImports.com Founder and CEO, Benjamin England.
For more on the Food Safety Modernization Act and how it affects companies, manufacturers and importers please visit:
http://www.fdaimports.com/FSMA
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
NSF International and its role in Dietary supplements & Nutraceutical industr...SyedArshiya4
This presentation will allow the reader to know about NSF international its history, mission, NSF Mark, role in Dietary supplements and Nutraceutical industries. It also give information on testing, inspection, certification of products.
plasma master file in European countries and requirements in letter of intent...Sanjay batra
it includes that what is plasma master file, principles, procedure to file PMF, strategy involved, administration information, certification procedure & inspection
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.
REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS A GLOBALKapilKumar198
This presentation contains detailed information about the regulatory aspects of food and nutraceuticals a global prospective, which includes WHO guidelines on nutrition and NSF International.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
The recently enacted Food Safety Modernization Act is the greatest expansion of FDA’s food regulatory authority since the enactment in 1938 of the Federal Food, Drug, and Cosmetic Act. This presentation discuses the scope, impact and implementation of the Act. Presented by FDAImports.com Founder and CEO, Benjamin England.
For more on the Food Safety Modernization Act and how it affects companies, manufacturers and importers please visit:
http://www.fdaimports.com/FSMA
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
NSF International and its role in Dietary supplements & Nutraceutical industr...SyedArshiya4
This presentation will allow the reader to know about NSF international its history, mission, NSF Mark, role in Dietary supplements and Nutraceutical industries. It also give information on testing, inspection, certification of products.
plasma master file in European countries and requirements in letter of intent...Sanjay batra
it includes that what is plasma master file, principles, procedure to file PMF, strategy involved, administration information, certification procedure & inspection
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.“
The benefits and risks associated with functional foods and nutraceuticals are presented in the presentation. Also, way-forward is captured in light of the risks.
This presentation covers (1) Social impact of tourism; (2) Effects of globalization on tourism development; (3) Sex tourism and exploitation of women; and (4) Trends and issues shaping tourism and hospitality development.
Explore the Association for Vertical Farming infographics surrounding the topic of Urban and Vertical Farming. For more information, visit the Vertical Farming website: https://vertical-farming.net/
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
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Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
Model Attribute Check Company Auto PropertyCeline George
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An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
We all have good and bad thoughts from time to time and situation to situation. We are bombarded daily with spiraling thoughts(both negative and positive) creating all-consuming feel , making us difficult to manage with associated suffering. Good thoughts are like our Mob Signal (Positive thought) amidst noise(negative thought) in the atmosphere. Negative thoughts like noise outweigh positive thoughts. These thoughts often create unwanted confusion, trouble, stress and frustration in our mind as well as chaos in our physical world. Negative thoughts are also known as “distorted thinking”.
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?
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.