It is independent, non-profit and non-governmental organisation

1. National Sanitation Foundation(NSF)
Certification,
and Standards for
Food and Dietary Supplements
Under the guidance of
Dr. Lakshmi Prasanthi Nori
Professor
Department of Regulatory Affairs
Presented by:
Bandaru Mani Sai Durga
1st M. Pharmacy (Regulatory Affairs)
Reg no: 222301
Shri Vishnu College of Pharmacy
MRA 204T
UNIT 2

2. INTRODUCTION HISTORY OBJECTIVES CERTIFICATION
PROCESS OF
CERTIFICATIO
N
NSF
STANDARDS
FOR DIETARY
SUPPLEMENTS
STANDARDS
FOR DIETARY
SUPPLEMENT
DIETARY
SUPPLEMENTS
CLAIMS
LABELING
NSF FOOD
SAFETY
STANDARDS
CONTENTS

3. NSF Certification Mark
• Formation : 1944
• Type : Testing, inspection, certification, training, and
consulting
• Legal status : Not-for-Profit
• Purpose : Improve and protect human health worldwide.
• Headquarters : Ann Arbor, Michigan, United States
• Region served : 150 countries
• President and CEO : Pedro Sancha
• Staff : 1,200 (2011)
• Website : www.nsf.org

4. INTRODUCTION
• It is an independent, not-for-profit, non- governmental
organization, is dedicated to being the leading global provider of
public health and safety risk management solutions while serving the
interests of all stakeholders.
• NSF accredited third-party certification provides all stakeholders –
industry, regulators, users and the general public – assurance that a
certified product, material, component or service complies with the
technical requirements of the referenced standard.

5. • NSF has developed more than 80 public health and safety American
National Standards which include over 12,000 food safety
requirements and over 3000 water quality requirements.
• NSF operates more than 165,000 square feet (15,300 m2) of
laboratory space and serves companies in more than 150 countries
worldwide.

6. HISTORY
• NSF International was founded in 1944 as the National Sanitation
Foundation.
• NSF developed the first standards for the sanitation of soda fountain
and luncheonette equipment in the early 1950s.
• To develop uniform, consensus-based national standards, NSF bring
together regulators, industry, consumers and public health experts.
• In 2022, they changed name from NSF International to NSF

8. S.no YEAR PROGRAMME
1. 1944 Walter Snyder, Henry Vaughan and Nathan Sinai found the National Sanitation Foundation (NSF) in
the University of Michigan School of Public Health.
2. 1952 • NSF establishes the Council of Public Health Consultants.
• They introduce NSF Standards 1 and 2, the first food equipment standards.
3. 1960 Standard 9 is developed, and the pool, spa and hot tub products certification programme begins.
4. 1965 The plastics piping and wastewater treatment programme begin.
5. 1967 NSF Testing Laboratories becomes a not-for-profit corporation.
6. 1980 NSF develops the first national standard for water treatment chemicals (NSF 61) following the
passage of the Safe Drinking Water Act.
HIGHLIGHTS OF NSF HISTORY

9. S.no YEAR PROGRAMME
7. 1984 • The bottled water programme begins.
• NSF establish the Health Advisory Board.
8. 1985 NSF begins expansion outside the United States by opening its European headquarters in Brussels, Belgium.
9. 1991 • ISO 9000 programme begins.
• NSF receive accreditation by the American National Standards Institute (ANSI).
10. 1996 • NSF-ISR is established as a wholly owned subsidiary of NSF.
• NSF is designated a Collaborating Center on Drinking Water Safety and Treatment by the World Health
Organization (WHO).
11. 1999 We establish the Center for Public Health Education at NSF.
12. 2001 We begin helping businesses manage food safety across the supply chain with the acquisition of Cook &
Thurber, LLC.
NSF launches a testing and certification programme for dietary supplements.
HIGHLIGHTS OF NSF HISTORY

10. S.no YEAR PROGRAMME
13. 2002 NSF introduce a dietary supplement GMP (Good Manufacturing Practice) registration programme.
14. 2003 NSF develops NSF/ANSI 173, the first American National Standard for dietary supplements.
15. 2004 We introduce Certified for Sport®, an athletic banned substances certification programme recognised by
major sports organisations such as the NFL, MLB and their player associations, PGA, LPGA and the
Canadian Centre for Ethics in Sport (CCES).
16. 2005 NSF launches a presence in Asia-Pacific with NSF Shanghai Co. Ltd. in the People's Republic of China.
17. 2007 NSF acquires David Begg Associates and enters the pharmaceutical and biotech industries.
18. 2008 We begin an environmental sustainability programme to help businesses improve the environmental
performance of products, operations, systems and supply chains.
HIGHLIGHTS OF NSF HISTORY

11. S.no YEAR PROGRAMME
19. 2010 NSF launches a certification programme to verify the quality, safety and performance of automotive
aftermarket parts.
20. 2011 NSF introduce a home product certification programme to test and certify home kitchen products and
appliances.
21. 2014 NSF introduces a cosmetics programme, providing cosmetic manufacturers with auditing, training, product
testing and certification services.
22. 2019 NSF earn LEED Gold® certification for the labs and office space at our Ann Arbor headquarters.
23. 2022 Pedro Sancha is appointed President and CEO of NSF.
HIGHLIGHTS OF NSF HISTORY

12. NSF Logo Evolvement

13. OBJECTIVES
• Primary Objective of NSF is to help improve the safety and quality
of food ,water consumer products and the environment.
• Development of public health standards by testing, inspecting and
certifying products and systems.
• To provide wide range of education, training and advisory to
manufacturers and stake holders.

14. CERTIFICATION
• The NSF Certification Mark indicates that the product meets quality
and safety standards.
• NSF Certification Requirements:
• NSF developed NSF/ANSI standard 173
• To help protect consumers by testing for contaminants and certifying
that NSF certified supplements contain the ingredients listed on label
and nothing else.

17. PROCESS OF CERTIFICATION
Label
Claim
Review
Toxicology
Review
Contaminant
Review
Facility
Audits
Ongoing
Monitoring

18. NSF standards for Dietary Supplements
• A dietary supplement is a manufactured product intended to
supplement one's diet by taking a pill, capsule, tablet, powder or
liquid. A supplement can provide nutrients either extracted from food
sources or that are synthetic in order to increase the quantity of their
consumption.
• The class of nutrient compounds includes vitamins, minerals, fiber,
fatty acids and amino acids.

19. NSF standards for Dietary Supplements
NSF follows the American National Standards Institute (ANSI) standards
development process.
Provides test methods and evaluation criteria for Dietary Supplements.
• To determine ingredients in the products are accurately identified.
• The amount of each dietary ingredient and/or marker constituent must be stated
on the labels of products other than proprietary blends, which must be labelled by
common name in line with the Merck Index or, when available, in accordance
with the relevant regulatory agency instructions.

20. STANDARDS FOR DIETARY SUPPLEMENT
1. Formulation submission
• The manufacturer should submit complete formulation information,
which includes :
• The composition of the formulation( (in percent or parts by weight for
each ingredient in the formulation including excipients).
• The reaction process, if applicable.
• The component ID number, chemical/ material name, trade name and
supplier(s) for each chemical present in the formulation.
• A list of known or suspected impurities associated with the finished
product.

21. 2. Labeling and requirements
• The product label shall declare,
• The identity of dietary ingredient and/or maker constituent included in
product.
• The Quantity of each dietary ingredient and/or marker constituent.
• Must be labeled by common name according to Merck Index or in
accordance with a regulatory agency guidance.

22. 3. Product requirements
• Earlier products were generally verified by testing laboratories, but
some aspects are need to be audited.
• Now products verified by auditing and/or the testing is performed by
client.

23. Product
Requirements
Raw Materials Finished product
1. Identity Verified using test methods,
based on manufacturer’s claim.
• Manufacture must ensure that the
finished product shall contain each of
dietary ingredient declared on label.
• Dietary supplements should meet GMP
requirements.
2. Quantity Quantity of marked constituent shall
verified when declared on Certificate
of Analysis.
Verification tests performed to confirm
quantity of dietary ingredient.
3. Contaminants
a. Metals
• Arsenic content not more than
5ppm
• Cadmium content not more than
0.3ppm
• Chromium content not more than
2ppm
• Lead content not more than
10ppm
• Inorganic Arsenic not more than
0.01mg/d
• Cadmium not more than 0.006mg/d
• Chromium not more than 0.02mg/d
• Lead not more than 0.02mg/d
• Mercury not more than 0.02mg/d

24. Product Requirements Raw Materials Finished product
b. Pesticides • Manufacture should screen for particles or use a certified
organizational ingredients as demonstrated in GMP audit .
• Must taken care of absence of banned pesticides.
c. Microbiological pesticides Afllatoxins not greater than
20ppb
Finished product in liquid form
with alcohol must not contain
pseudomonas auroginosa .

25. DIETARY SUPPLEMENTS CLAIMS
1.Health Claims :
• Health claims show a link between a food or substance and a disease
or health-related condition.
2.Structure /Function Claim:
• It refer to the supplement's effect on the body's structure or function,
including its overall effect on a person's well-being.
3.Nutrient Content Claim:
• Nutrient content claims describe the level of a nutrient in a food or
dietary supplement.

26. LABELING
• Serving Size :Size is normally stated per tablet, per capsule, per
packet or per teaspoonful.
• International unit (IU) :This is a unit of measurement, frequently
used for vitamins A and D. Defined individually for each substance.
• MG and MCG :These are common units of measurement for
minerals and some vitamins, such as vitamin C.
• Daily value (DV) :The daily value, or DV, is the average amount of
the vitamin or mineral needed to meet the nutritional requirements
of a person of at least age four.

27. NSF FOOD SAFETY STANDARDS
NSF manages food safety across the supply chain by testing, auditing,
certification and regulatory compliance. NSF is a pioneer in food safety for
over 75 years.
Exploration Solution Areas:
• Food Safety Audits and Certification
• Food and Beverage Product Certification
• Food Equipment and Appliances
• Management Systems

28. Supplier
Assurance
Audit
Agricu-
luture
and
Farmin
g
Manufacturi-
ng,
Packaging
and
Distribution
Certifications
Seafood Supply
Chain
Sustainabili-
ty
Import
Supplier
Certification
Switch
your
Certifica-
tion to
NSF
Food Safety Audits and Certification

29. Food and Beverage Product Certification
• Non-GMO Verification
• Organic Certification
• Plant based Certification
• Vegan Certification
• Raised without Antibiotics Certification
• Gluten-free Certification
• Kosher Certification
• Honey Traceability and Authenticity Certification
• Bottled Water and Packaged Ice Certification

30. Food Equipment and Appliances
• Nonfood Compounds and Chemical Registration and Certification
• Home Products and Appliances Certification
• Food Equipment Certification
• HACCP Compliance Verification for EU and Indian markets
• Field Labeling
• Food Contact Materials Testing
• Food Equipment Pre-evaluation
• Electrical Safety

31. Management Systems
Quality
Management
System
ISO 9001
FSSC 22000
Certification
Environmental,
Occupational Health
and Safety
Management System
ISO 14001
RCMS
Certification
ISO45001/O
HAS 18001
Information
Security
Management
Systems
ISO/IEC 27001 ISO/IEC20000-1

32. Conclusion
NSF certification for dietary supplements provides assurance of safety,
quality, and compliance with industry standards. The certification
verifies accurate labeling, absence of contaminants, and adherence to
Good Manufacturing Practices. Choosing NSF-certified supplements
ensures confidence in their quality and transparency.

33. QUESTIONS
1. What is NSF? Write the process certification?
2. What are the standards of dietary supplement?

34. References
• https://www.slideshare.net/AtulBhombe/nsf-certification-
standard-for-dietary-supplement?from_search=0
• https://www.mpofcinci.com/blog/nsf-food-safety-guidelines-for-
equipment-manufacturers/
NSF | The Public Health and Safety Organization
• NSFhttps://www.nsf.org