The document provides an overview of functional food development and legislation. It discusses key topics such as the definition of functional foods, common functional food ingredients and their properties, regulations around health claims for functional foods, and guidelines for developing and marketing new functional food products. The document also reviews the functional food framework in the EU and provides examples of regulatory bodies that evaluate evidence to support claims about functional foods and their health benefits.

1. Lithuanian University of Health Sciences
 FUNCTIONAL FOOD DEVELOPMENT AND
LEGISLATION (I)
 Prof. Dalia Sekmokiene

2. Summary of subject
 Functional food conception, definition and terms.
 Functional food using and production experience in EU and other
countries.
 Functional food ingredients, their physiological and technological
properties. Classification of functional food ingredients: dietary fiber,
vitamins and antioxidants, herbal extracts and their components, fatty
acids, prebiotic and probiotic.
 Technological rules of creation of functional food products.
Reglamentation of functional food, health claims.
 Functional food ingredients and products quality.
 Research position about non traditional diet theories and possibilities
to adjust this experience in the functional food and dietary supplement
producing.

3. Introduction
Diet is a major focus of public health strategy aimed
atmaintaining optimum health throughout life, preventing
earlyonset of chronic diseases as well as promoting
healthierageing.
The growing demand for healthy foods is stimulating
theinnovation and new product development internationally.
Food industry has a central role in facilitating healthiereating
practices through the provision and promotion ofhealthy
foods.
Continuously increasing consumers health consciousnessand
expenditure are socio-economic factors responsible for the
expanding worldwide interest in functional foods.

4. Objectives
 Objectives: acquaint students with functional food
conception and legal terms, functional food
ingredients. Train about functional food regulation,
safety, quality assessment, methods of quality
measurement. Introduce about functional food
creation general technological principles, general
theoretical knowledge and practical proficient about
functional food production, health claim regulation,
control assessment and safety.

5. Abbreviations:
 A - Activity
 S - settlement of a seminar topic
 E - exam
 JI - Joint Assessment
 JI = Ax0,2 + Sx0,5 + Ex0, 3
 Activity -lab and lecture attendance, timely defense seminars assessed 10x0, 2.
 From the evaluation (10 points) minus the 1 point for the following:
 -omission without a valid reason, no laboratory work;
 -omission, without reason, two lectures;
 -non-timely preparing for the workshop;
 -a negative assessment;
 The seminar grade is to defend the seminar evaluation Sx0.5.
 The examination must be passed to a positive grade (at least 5 Scores).
 IF the activity and student symposia collected at least 5 points and the rating it is
satisfied, the test can not identify the student.

6. Accepted capacity
 After completing the subject, students should
be able to: to dig for information about
functional food ingredients, general
technologies in Lithuania and other counties,
functional food legislation, regulation.
 Must be able to control functional food safety
and quality. Functional food consumption,
targeted selection should contribute to public
health and reduce the likelihood of morbidity.

7. Lectures:
 1. Functional food – introduction: functional food
concept, definition and functional food terms.
 2. Functional food development and legislation.
Nutrition and health claims made on foods
(according Regulation (EC) No 1924/2006).
Conditions for the use of nutrition and health claims,
scientific substantiation for claims.
 3.Functional food ingredients, theirs physiological
and technological functions. Different groups of
functional food ingredients, databases, singularity of
rare ingredients.

8. Lectures:
 4. Properties, health claims and usage of
prebiotics and probiotics
 5. Nutritive fiber definition. Plant fiber and its
properties. Fiber technological properties and
therapeutic efficacy. Fatty acids.
 6. Peptide and protein functional properties.
Food products containing biologically active
proteins

9. Lectures:
 7.Plant extracts and their active substances.
Functional food ingredients of plant origin,
their appliance for products development.
 8. Functional dairy production: technology,
safety.
 9. Functional meat products.

10. Practical works and seminars:
1. Regulation on nutrition and health claims (EC 1924/2006) .
2. Funkcional milk products labeling analysis (according HN 119
and EC 1924/2006), labeling of probiotics and prebiotics.
3. Vitamins in food labeling, regulation 1925/2006 analysis..
4. Seminar for students on the topic.
5. Seminar for students on the topic.
6. Seminar for students on the topic.
7. Seminar for students on the topic
8. Seminar for students on the topic.
9. Nutrition and health claims validation and analysis (EC353/2008).
10. Workshop: non-animal origin funkcional food production
technologies. Nutrition claims for theese products.

11. History
The history of functional foods is quite
short and related to the general rise in
health-oriented thinking. The term
functional food was first introduced in
Japan in 1987.

12. History
 In 1991, the concept of Foods for Specified
Health Use (FOSHU) was established. Foods
identified as FOSHU must be approved by
Minister of Health and Welfare after the
submission of comprehensive science-
based evidence to support the claim for the
foods when they are consumed as part of an
ordinary diet.

13. Logotip of FOSHU (Japan)

14. Definition
 No universally accepted definition for functional foods exist
Functional foods are food items
consumed as part of the daily diet and
have specific physiological effect over
and above normal nutritional
requirements.

15. Definition
 A food can be regarded as ‘functional’ if it is
satisfactorily demonstrated to affect
beneficially one or more target functions in
the body, beyond adequate nutritional effects
in a way which is relevant to either an
improved state of health and well-being
and/or reduction of risk of disease.

16. Definition
 The fundamental reguirements for a product
to be designated as functional are:
 It is food - not a capsule or powder wchich is
derived from naturally occuring substances;
 It can and should be consumed as a part of
the daily diet;
 When ingested, its particular function is to
regulate a specified body process.

17. How is area of health claims
regulated?
Physiological function of foods is
are of health claims regulation

18. How is area of health claims
regulated?
 Functional Foods are claimed to have
specified health enhansing effect which can
be caused by different components-
ingredients.

19. Main functional food ingredien
Dietary fiber
Oligosacharides
Peptides and proteins
Vitamins and minerals
Polyols
Fatty acids
Herbal extracts
Lactic acis bacteria
Antioxidants

20. Functional food
 Some states regulations defin that as
functional food may be oat products, wheat
brain, some vegetable products, flaxeed
products and others. They are not enriched
by ingredients, but naturally have many
useful componenets.

21. How is area of health claims
regulated?
 Many academic, scientific and regulatory
organizations are actively working on ways to
establish the scientific basis to support claims for
functional ingredients or the foods containing them.
 Any regulatory framework will need to protect
consumers from false and misleading claims and to
satisfy the needs of industry for innovation in product
development, marketing and promotion.

22. How is area of health claims
regulated?
 In the US, “reduction of risk of disease”
claims have been permitted since 1993 for
certain foods. Health claims are authorized
by the US Food and Drug Administration
(FDA) on the basis of “the totality of publicly
available scientific evidence and where there
is significant scientific agreement amongst
qualified experts that the claims are
supported by the evidence”.

23. IFT (Institute of Food Technologist)
Expert Panel Report
 New IFT (USA) Expert panel report provides
a comprehensive review of functional foods
and a seven-step process for designing,
developing and marketing them.

24. IFT (Institute of Food Technologist)
Expert Panel Report
All seven steps will be undertaking for each
new functional food ingredient .
1. Identify the relationship between the
food component and the health benefit.

25. IFT (Institute of Food Technologist)
Expert Panel Report
2. Demonstrate efficacy and
determine the intake level
necessary to achieve the
desired effect.

26. IFT (Institute of Food Technologist)
Expert Panel Report
3. Demonstrate safety at
efficacious levels.
4. Develop a suitable food matrix
for the bioactive component.

27. IFT (Institute of Food Technologist)
Expert Panel Report
5. Demonstrate sufficiency of the
scientific evidence for efficacy.
6. Communicate benefits for
consumer.
7. Conduct in-market confirmation of
efficacy and safety.

28. European legal framework of function
foods and health claims
 Because of increasing interest in the concept
of “Functional Foods” and “Health Claims”,
the European Union set up a European
Commission Concerted Action on
Functional Food Science in Europe
(FUFOSE).

29. European legal framework of function
foods and health claims
 FUFOSE programme was coordinated by the
International Life Sciences Institute (ILSI) Europe
and the aim was to develop and establish a science-
based approach to the evidence needed to support
the development of food products that can have a
beneficial effect on an identified physiological
function in the body, that can improve an individual’s
state of health and well-being and/or reduce the risk
of disease.
 The FUFOSE project looked at nine areas of science
and health.

30. European legal framework of function
foods and health claims
 The EU Concerted Action supports the
development of two types of health claims
relevant to functional foods, which must
always be valid in the context of the whole
diet and must relate to the amounts of foods
normally consumed.

31. European legal framework of function
foods and health claims
These are:
1. TYPE A: “Enhanced function” claims that refer to
specific physiological functions and biological
activities beyond their established role in growth,
development and other normal functions of the
body.
This type of claim makes no references to a
disease or a pathological state, e.g. certain non-
digestible oligosacharides improve the growth of a
specific bacterial flora in the gut.

32. European legal framework of function
foods and health claims
2. TYPE B “Reduction of disease-risk” claims that
relate to the consumption of food or food
component that might help reduce the risk of a
specific disease or condition because of specific
nutrients or non-nutrients contained within it (e.g.
folate can reduce a woman’s risk of having a child
with neural tube defects, and sufficient calcium
intake may help to reduce the risk of osteoporosis
in later life).

33. Validation of claims and safety aspects
 The FUFOSE conclusions and principles
need to be implemented. Therefore, a new
EU commission Concerted Action
programme, the Process for the
Assessment of Scientific Support for Claims
on Foods (PASSCLAIM) projects is aiming to
resolve some of the ongoing issues of
validation, scientific substantiation of claims
and communication to the consumer.

34. Validation of claims and safety aspects
 The project started with and will build upon the
principle that “Enhanced function” and “Reduced risk
of disease” claims should not be based on well
designed studies using appropriately identified,
characterized and validated biomarkers.
 PASSCLAIM aims to establish common criteria to
assess the scientific substantiation of health-claims,
providing the framework to prepare scientific
dossiers supporting claims.

35. Validation of claims and safety aspects
 The PASSCLAIM Consensus Document
assist to make science base related to claims
on foods and prepare ES regulation.
 Regulation EC No 1924/2006 on nutrition
and health claims made on foods.

36. Regulation EC No 1924/2006 on nutrition
and health claims made on foods
 ‘claim’ means any message or
representation, which is not mandatory under
Community or national legislation, including
pictorial, graphic or symbolic representation,
in any form, which states, suggests or implies
that a food has particular characteristics;

37.  nutrition claim’ means any claim which states,
suggests or implies that a food has particular
beneficial nutritional properties due to:
 (a) the energy (calorific value) it
 (i) provides,
 (ii) provides at a reduced or increased rate, or
 (iii) does not provide; and/or

38.  (b) the nutrients or other substances it
 (i) contains,
 (ii) contains in reduced or increased
proportions, or
 (iii) does not contain;

39.  ‘health claim’ means any claim that states,
suggests or implies that a relationship exists
between a food category, a food or one of its
constituents and health;

40.  ‘reduction of disease risk claim’ means
any health claim that states, suggests or
implies that the consumption of a food
category, a food or one of its constituents
significantly reduces a risk factor in the
development of a human disease;

41. Regulation EC No 1924/2006 on nutrition
and health claims made on foods
 Scientific substantiation for claims
 1. Nutrition and health claims shall be based
on and substantiated by generally accepted
scientific data.
 2. A food business operator making a
nutrition or health claim shall justify the use
of the claim.

42. LIST OF EDA HEALTH CLAIMS
UNDER ARTICLE 13 REGULATION EC No
1924/2006
ON NUTRITION AND HEALTH CLAIMS MADE
ON FOODS
4 september 2007

43. LIST OF EDA HEALTH CLAIMS
UNDER ARTICLE 13 REGULATION EC No 1924/2006
ON NUTRITION AND HEALTH CLAIMS MADE ON FOODS
 Content
 The document is organized in three parts giving (1)
an overview of the health claims covered in this
document, (2)
 the actual information about the health claims and
(3) the translation of the examples of wordings into
different
 European languages in the annex.
 The overview contains - for each health claim -
information on the health relationship, the conditions
of use, the

44. Validation of claims and safety aspects
 Although there is no European legislation
regarding safety of functional foods as such,
the food safety aspects are already covered
by existing EU regulations.

45. Validation of claims and safety aspects
 Same regulatory aspects of functional foods
have Finland, UK and Netherlands

46. The Finish Law on health Claims
 The Finnish Law on Food allowed three
types of health related claims:
 Nutritional facts
 Claims related to vital functions
 Claims related to lowering the risk of disease

47. The Finish Law on health Claims
 Using a nutritional fact in marketing is an
implication that the product contains a
nutritious ingredients (fibre, vitamins,
proteins) and is a part of healthy diet.

48. The Finish Law on health Claims
 Claims related to vital function are claims that are
connected to a specific health effect. According to
the Finish regulation, it is allowed to use claims
relating to good health, dental health, weight, blood
pressure, cholesterol level.
 In all cases, misleading or insufficient information is
strictly forbidden.
 Examples of claims relating to vital functions are
“xylitol is good for teeth” or “bacterium LGG
improves good health”.

49. The Finish Law on health Claims
 Claims related to lowering the risk of
disease are allowed in very limited cases.
Health claims must to be based on scientific
criteria.

50. Health claims according to the Finnish
Law on Food
HELATH CLAIMS IN
RELATION TO
ACCORDING TO THE
FINNISH LAW
EXAMPLE
Nutritional facts Allowed with
substantive evidence
Contains added vitamin
and calcium
Vital functions Allowed with
substantive scientific
evidence
Helps to balance the
stomach functioning
Lowering the risk of
disease
Allowed in limited
cases with unbiased,
reputable scientific
evidence
Regular use lowers the
risk of dental caries
Preventing or curing
disease
Forbidden Prevents osteoporosis

51. Functional Food in Lithuania
 Lithuania produce many food products, which
can be regarded as functional: dairy products
with prebiotics and probiotics, whey drinks
with ω-3 fatty acids, mineral water with L-
carnitine, cereals with vitamins, minerals and
others.

52. Functional Food in Lithuania
 Lithuanian Veterinary academy with
collaboration with Lithuanian Food Institute
provides scientific and methodical assistance
to functional food related enterprises
promoting quality and safety of Lithuanian
food products seeking integration into the
common EU market.

53. Functional Food in Lithuania
 The fundamental and applied research is focused on the
following problems of functional food science and
technology:
 Development of the scientific and technological principles for
the manufacture of functional food products;
 Developing of national food law regarding functional food
products (conception of functional food products and
requirements for functional food products).
 Creation of a data base of functional food and its ingredients;
 Implementation of joint research projects and teaching
consumers and producers.

54.  THANK YOU FOR YOUR ATTENTION