functional food llegislation-introduction-1 lec

Lithuanian University of Health Sciences

FUNCTIONAL FOOD DEVELOPMENT AND LEGISLATION (I)

Prof. Dalia Sekmokiene

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

Logotip of FOSHU (Japan)

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.

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.

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.

How is area of health claims regulated?

Physiological function of foods is are of health claims regulation

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.

Main functional food ingredien

Dietary fiberOligosacharidesPeptides and proteinsVitamins and mineralsPolyolsFatty acidsHerbal extractsLactic acis bacteriaAntioxidants

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.

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.

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”.

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.

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.

IFT (Institute of Food Technologist) Expert Panel Report

2. Demonstrate efficacy and determine the intake level necessary to achieve the desired effect.

IFT (Institute of Food Technologist) Expert Panel Report

3. Demonstrate safety at efficacious levels.

4. Develop a suitable food matrixfor the bioactive component.

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.

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).

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.

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.

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.

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).

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.

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.

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.

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;

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

(b) the nutrients or other substances it (i) contains, (ii) contains in reduced or increased

proportions, or (iii) does not contain;

‘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;

‘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;

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.

LIST OF EDA HEALTH CLAIMSUNDER ARTICLE 13 REGULATION EC No

1924/2006ON NUTRITION AND HEALTH CLAIMS MADE

ON FOODS

4 september 2007

LIST OF EDA HEALTH CLAIMSUNDER ARTICLE 13 REGULATION EC No 1924/2006ON 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

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.

Validation of claims and safety aspects

Same regulatory aspects of functional foods have Finland, UK and Netherlands

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

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.

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”.

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.

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

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.

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.

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.

THANK YOU FOR YOUR ATTENTION