**7. Probiotics and probiotic functional foods – Legislation and modern challenges**

fermented milk product with the typical bacterial cultures *Lactobacillus bulgaricus* and *Streptococcus thermophilus* (the standards of identity, published in the US Code of Federal

In Commission Regulation (Elf) No 432/2012 in the list of the permitted health claims made on foods, the only probiotic microorganisms included are *Lactobacillus bulgaricus* and *Streptococcus*

colony forming units, they improve

*thermophilus*. According to the claim, in doses over 108

Regulations).

lactose digestion [60].

**Figure 3.** Dr Stamen Grigorov

**Figure 2.** Prof. I. Metchnikoff

204 Immunopathology and Immunomodulation

According to the World Health Organization (WHO) and the Food and Agriculture Organi‐ zation (FAO), probiotics are live microorganisms which, when administered in adequate amounts, confer a health benefit on the host [65].

For the last decades, there has been a rapid growth in the application of probiotics among both people and animals. They are used in the production of fermented products (milk, cheese), as ingredients in adapted milk for babies and children, in bakery products or confectionery, or as material for the production of food additives. Another modern trend in agricultural science is the use of probiotics in animal breeding and poultry farming to reduce the disease rates with young animals, for maximum utilization of nutrition ingredients of fodder, and fast accumulation of muscle mass without treatment with hormonal preparations and antibiotics, as well as to increase the volume of additional products that animals and poultry give – eggs, milk, etc.

Probiotic microorganisms belong to the *Lactobacillus, Lactococcus, Bifidobacterium, Pediococcus,* or *Bacillus* family, with the microorganisms from Lactobacillus family being most frequently used as probiotics.

According to Claire M. Hassler from the Illinois University, the probiotics from the Lactoba‐ cillus family are functional ingredients contained in yogurt and other dairy products, which improve the health condition of the gastrointestinal tract. Many researches confirm the health benefits of probiotics for maintaining gastrointestinal health, avoiding infections through competitive suppression of the development of pathogenic strains, strengthening the immune system, prevention against colorectal cancer, reduction of serum cholesterol, relieving intolerance toward lactose, etc.

Probiotics have healthy effect if taken in specific quantities. According to the Japanese scientists, N. Ishibashi and S. Shimamura, the recommended quantity of live microorganisms in a probiotic product must be at least 107 live microorganisms per gram or per milliliter. According to other scientists, Gomez and Vinderola, the minimum required concentration of live cells in each gram probiotic product at the moment of consumption must be from 106 to 109 to have any favorable effect.

Today, the market offers a wide range of probiotic products and most of them are in dry forms. A number of factors have influence on the expiry periods of dried probiotic products and their subsequent effect when consumed. The creation of probiotic formulas with lasting durability of the strains and longer expiry periods still continues to be a challenge. Manufacturers of probiotic products constantly apply innovations, which aim to preserve the vitality of probiotic strains during the drying process (lyophilization), rehydration, when passing through the gastrointestinal tract and the strongly alternating pH in the stomach and biliary salts, and during their storage in the sales points. There are numerous researches of the molecular characteristics of probiotic strains and their health effects.

Companies apply different approaches to create new probiotic formulas with preserved vitality of the strains and useful effects. Some Korean and Japanese companies divide probiotic products into four generations:


Some scientists apply genetic manipulation of known strains to increase their durability. American companies test possible probiotic effects of known spore-carrying microorganisms from the Bacillus family.

Bulgarian manufacturers of probiotics coat the strains of lactic acid microorganisms with natural coating, which consist of ingredients of the food media aiming to raise their durability with the alternating pH and temperature. The Bulgarian scientist, Nikola Alexandrov and his fellow researchers, isolated for the first time in the world 8 completely natural probiotic strains from the Lactobacillus family from pure spring water in Bulgaria [62,63] [Figure 4].

**Figure 4.** Probiotics from spring water

For the last decades, there has been a rapid growth in the application of probiotics among both people and animals. They are used in the production of fermented products (milk, cheese), as ingredients in adapted milk for babies and children, in bakery products or confectionery, or as material for the production of food additives. Another modern trend in agricultural science is the use of probiotics in animal breeding and poultry farming to reduce the disease rates with young animals, for maximum utilization of nutrition ingredients of fodder, and fast accumulation of muscle mass without treatment with hormonal preparations and antibiotics, as well as to increase the volume of additional

Probiotic microorganisms belong to the *Lactobacillus, Lactococcus, Bifidobacterium, Pediococcus,* or *Bacillus* family, with the microorganisms from Lactobacillus family being most frequently

According to Claire M. Hassler from the Illinois University, the probiotics from the Lactoba‐ cillus family are functional ingredients contained in yogurt and other dairy products, which improve the health condition of the gastrointestinal tract. Many researches confirm the health benefits of probiotics for maintaining gastrointestinal health, avoiding infections through competitive suppression of the development of pathogenic strains, strengthening the immune system, prevention against colorectal cancer, reduction of serum cholesterol, relieving

Probiotics have healthy effect if taken in specific quantities. According to the Japanese scientists, N. Ishibashi and S. Shimamura, the recommended quantity of live microorganisms in a probiotic product must be at least 107 live microorganisms per gram or per milliliter. According to other scientists, Gomez and Vinderola, the minimum required concentration of live cells in each gram probiotic product at the moment of consumption must be from 106

Today, the market offers a wide range of probiotic products and most of them are in dry forms. A number of factors have influence on the expiry periods of dried probiotic products and their subsequent effect when consumed. The creation of probiotic formulas with lasting durability of the strains and longer expiry periods still continues to be a challenge. Manufacturers of probiotic products constantly apply innovations, which aim to preserve the vitality of probiotic strains during the drying process (lyophilization), rehydration, when passing through the gastrointestinal tract and the strongly alternating pH in the stomach and biliary salts, and during their storage in the sales points. There are numerous researches of the molecular

Companies apply different approaches to create new probiotic formulas with preserved vitality of the strains and useful effects. Some Korean and Japanese companies divide probiotic

**•** Second generation – probiotic microorganisms with single synthetic coating, which protects

to

products that animals and poultry give – eggs, milk, etc.

characteristics of probiotic strains and their health effects.

**•** First generation – probiotic microorganisms without coating

them when passing through the gastrointestinal tract

used as probiotics.

109

intolerance toward lactose, etc.

206 Immunopathology and Immunomodulation

to have any favorable effect.

products into four generations:

Research in this field will have major importance for the manufacturers of probiotics, who want to achieve longer term of durability and better health effect of their probiotic products. These researches are also extremely important for the end consumers who demand highquality functional products to improve the quality of their life.

#### **8. Probiotic functional foods**

The oldest concept of functional foods was created by the father of medicine – Hippocrates. He wrote, "Let food be your medicine and medicine – your food."

Food's major role is to provide sufficient nutritive substances, which will satisfy the need for food of the human organism. Today, nutrition science faces new challenges far beyond the concept of food insufficiency.

There are both socioeconomic changes taking place in the world and changes in the demo‐ graphic structure of population – growing number of elderly people and increase of the expenses for healthcare. Therefore, governments, researchers, health experts, and the foodstuff industry, in general, direct their efforts to identification and creation of functional foods, which may improve the health of the local population, reduce the risk of diseases with social impact, such as cardiovascular diseases, cancer, osteoporosis, and improve the quality of life for the people. In combination with healthy living, the daily use of these functional foods may have positive impact for the health of both working people in active age and their families and for the elderly. This will result in the sharp reduction of the expenses for healthcare and in the optimization of physical and mental health of the population.

Nowadays scientific evidences proved that some foods and food ingredients have favorable physiological and psychological effects beyond the supply with major food substances. Modern researches focus on the identification of the biologically active components in food, which maintain human health and reduce the risk of diseases. It has been found that many traditional foodstuffs, such as eggs, milk, whole-wheat food, fruits, vegetables, soya, etc. contain components of potential benefit for health. Apart from these foods, there are new products that have been developed to increase or combine these useful components because of their benefits or desired physiological effects.

Functional foods are foods that are consumed as part of the normal nutrition process. They have useful effects when consumed in normal quantities within the dietary regime. Functional food could be:


Functional food may be addressed to the overall population or separate groups identified in terms of age (e.g., children or adults), genetic and enzyme modifications (intolerance toward gluten, lactose intolerance), functional status (pregnancy, for example), etc. Functional foods must be in conformity with the overall significance of nutrition – potential interrelations with other food substances and ingredients or possible undesired effects, including allergies and intolerance.

The foundations of the modern science of functional foods were laid in Japan during the 1980. The concept of food of specific health use (FOSHU) was established in 1991. Foods defined as FOSHU are approved by the Minister of Health and Social Cares of Japan after providing detailed and sufficient scientific evidence. Such foods are consumed as part of the standard diet [66]. In USA, the requirements for "reduction of the risk of diseases" for specific foods were made binding by law in 1993. The opinions and conclusions related to health are subject to approval by the Food and Drugs Agency on the base of scientific evidence and their goal is to help consumers by providing information about healthy nutrition, thus avoiding the risk of diseases [67]. In the European Union, the development and the approval of functional foods is regulated by a special organization to the European Commission known as FUFOSE (Functional Food Science in Europe) in cooperation with the European ILSI (International Life Science Institute), which works mainly on issues referring to the harmonization of the legislation in the field of functional foods in the EU Member States. This European Commission has developed two types of health requirements for functional foods: "increased function" and "reduction of the risk of disease" [60]. In Bulgaria, the permit for the production of food with special designation is given by the Bulgarian Food Safety Agency (BFSA) after provision of scientific evidence to the Ministry of Health of the Republic of Bulgaria [63, 67].

The biggest challenge before the scientists in the field of nutrition now and in the future is to research the interrelations between a given food or food ingredient and the improved health and reduced risk of various diseases. The provision of accessible and detailed information for the qualities of the functional foods is of exceptional importance for the consumers' choice of food.
