Regulatory Aspects Related to Plant Sterol and Stanol Supplemented Foods

Abstract This chapter reviews regulatory frameworks for plant sterol containing functional foods in various jurisdictions including Europe, North America, South America, Asia and, Australia/New Zealand. Included is a discussion on approval of plant sterols as novel food ingredients in some countries, as well as details on the type of health claims permitted in the marketing and sale of foods enriched with plant sterols within each jurisdiction. Based on the abundance of clinical trial data, many countries around the world have now approved the use of claims relating the cholesterol-lowering effect of plant sterols, further attesting to their value as functional food ingredients.

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Cardiovascular Safety of Plant Sterol and Stanol Consumption

Journal of AOAC International ◽

10.5740/jaoacint.sgesilbernagel ◽

2015 ◽

Vol 98 (3) ◽

pp. 739-741 ◽

Cited By ~ 5

Author(s):

Guenther Silbernagel ◽

Iris Baumgartner ◽

Winfried März

Keyword(s):

Plant Sterol ◽

Functional Foods ◽

Cardiovascular Health ◽

Low Density Lipoprotein ◽

Density Lipoprotein ◽

Plant Sterols ◽

Lipoprotein Cholesterol ◽

Low Density ◽

Low Density Lipoprotein Cholesterol ◽

Safety Issues

Abstract Plant sterols and stanols as components of functional foods are widely used for cholesterol lowering. The regular intake of these functional foods is associated with a decrease in low density lipoprotein cholesterol of about 10 % and an increase in plasma plant sterol or stanol concentrations by about a factor of 2. There is no doubt that a decrease in low density lipoprotein cholesterol is beneficial to cardiovascular health. However, due to the concomitant increase in circulating plant sterols safety issues associated with the intake of plant sterol containing functional foods have been raised. Herein, we will review and evaluate those arguments raised against the use of plant sterols and stanols.

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Simulation of prospective phytosterol intake in Germany by novel functional foods

British Journal Of Nutrition ◽

10.1079/bjn20041364 ◽

2005 ◽

Vol 93 (3) ◽

pp. 377-385 ◽

Cited By ~ 21

Author(s):

Karolin Kuhlmann ◽

Oliver Lindtner ◽

Almut Bauch ◽

Guido Ritter ◽

Brigitte Woerner ◽

...

Keyword(s):

Dairy Products ◽

Plant Sterol ◽

Functional Foods ◽

Plant Sterols ◽

Blood Cholesterol ◽

The Novel ◽

Consumption Data ◽

Food Applications ◽

Food Market ◽

Serving Size

A blood cholesterol-lowering margarine containing plant sterolesters was the first functional food placed on the European food market pursuant to the regulation (EC) 258/97. In the following years nine further applicants submitted the request to add plant sterol compounds to dairy products, cheeses, bakery products, sausages, plant oils and other products. The European Scientific Committee on Food (SCF) declared a precautionary intake limit of 3 g plant sterols per d by multiple dietary sources. Using the consumption data of the German National Food Consumption Study, carried out from 1985 to 1988 with 23 209 participants, we hypothetically added 0·3–2 g plant sterols to usual daily servings of ten different food products, selected from the novel food applications. We calculated the prospective plant sterol intake regarding each kind of enriched food and by stepwise accumulation of different functional foods in three enrichment scenarios. Within our enrichment context we find a phytosterol intake satiation, if multiple plant sterol-enriched foods are eaten. An enrichment amount of 2 g plant sterols per proposed food serving size results in an intake maximum of 13 g/d.

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10 Years of Functional Foods in Europe

International Journal for Vitamin and Nutrition Research ◽

10.1024/0300-9831.78.6.253 ◽

2008 ◽

Vol 78 (6) ◽

pp. 253-260 ◽

Cited By ~ 4

Author(s):

Paul Walter

Keyword(s):

Functional Foods ◽

Special Functions ◽

Scientific Evidence ◽

Biologically Active ◽

Health Claims ◽

Food Ingredients ◽

Disease States ◽

Consensus Document ◽

Main Emphasis ◽

Health And Disease

In 1999, the Scientific Concepts of Functional Foods in Europe: Consensus Document was published. In the last ten years the main emphasis of progress has been in the following areas: Functions of Food: It has become very clear that a large part of the known functions of vegetables, fruits and grains are not only due to the well known vitamins and minerals, but that a large variety of other non-nutritive biologically active compounds in these foods have also specific actions on human health. An increasing number of these food ingredients are now known. Claims relevant to Functional Foods: In a European Commission Concerted Action lead by ILSI Europe, the Assessment of Scientific Support for Claims on Foods (PASSCLAIM) led to criteria to assess the scientific evidence to support claims on foods. The relative strengths and limitations of types of scientific approaches and data that are relevant to different health and disease states as well as providing guidance on the interpretation of the criteria are also described. Legislation: The new European Regulation on Nutrition and Health Claims made on Foods entered into force on January 19, 2007. The regulation sets out conditions for their use, establishes a system for their scientific evaluation, and will create European lists of authorised claims. This process will be the most important development for the acceptance of foods with special functions in Europe.

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Cross-Sectional Study of Plant Sterols Intake as a Basis for Designing Appropriate Plant Sterol-Enriched Food in Indonesia

Nutrients ◽

10.3390/nu13020452 ◽

2021 ◽

Vol 13 (2) ◽

pp. 452

Author(s):

Drajat Martianto ◽

Atikah Bararah ◽

Nuri Andarwulan ◽

Dominika Średnicka-Tober

Keyword(s):

Low Income ◽

Plant Sterol ◽

Functional Foods ◽

Significant Risk ◽

Plant Sterols ◽

Blood Cholesterol ◽

Food Sources ◽

Consumption Pattern ◽

Cross Sectional ◽

Cholesterol Lowering

Coronary heart disease (CHD) is one of the leading causes of mortality in many low-income and middle-income countries, including Indonesia, with elevated blood cholesterol level being one of significant risk factors for this condition. The problem should be addressed by combining healthy lifestyle and diet, where functional foods having a cholesterol-lowering activity could play a significant role. A group of compounds that had been proven to show cholesterol-lowering ability are plant sterols. To develop more suitable functional foods that could substantially contribute to hypercholesterolemia prevention in Indonesian population, up-to-date data about plant sterols dietary intake are required, and were not available until this research was done. This study aimed to estimate daily plant sterols intake and to determine the consumption pattern of foods containing plant sterols in rural and urban area of Bogor, West Java, Indonesia. The research was conducted with a cross-sectional design, with 200 respondents. The study revealed that the level of plant sterols intake in Bogor reached on average 229.76 mg/day and was not significantly different between urban and rural area. Cereals, vegetables, and fruit products were the main food sources of plant sterols in both areas. In addition, a list of several surveyed food items possible to be enriched with plant sterols was developed within the study. These results provide baseline data to develop functional foods fortified with plant sterols suitable for the Indonesian needs and taste. However, further studies are needed to confirm efficacy and safety of introducing such phytosterol-enriched products into a habitual diet, especially considering possible long-term side effects of plant sterol treatment.

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Moving beyond the “LDL hypothesis”

VASA ◽

10.1024/0301-1526/a000451 ◽

2015 ◽

Vol 44 (5) ◽

pp. 333-340 ◽

Cited By ~ 7

Author(s):

Christian Werner ◽

Ulrich Laufs

Keyword(s):

Ldl Cholesterol ◽

Causal Relation ◽

Low Density Lipoprotein ◽

Density Lipoprotein ◽

Clinical Trial Data ◽

Randomised Clinical Trial ◽

Trial Data ◽

Low Density Lipoprotein Cholesterol ◽

Genetic Studies ◽

Statin Drug

Abstract. Summary: The term “LDL hypothesis” is frequently used to describe the association of low-density lipoprotein cholesterol (LDL-cholesterol, LDL-C) and cardiovascular (CV) events. Recent data from genetic studies prove a causal relation between serum LDL-C and CV events. These data are in agreement with mechanistic molecular studies and epidemiology. New randomised clinical trial data show that LDL-C lowering with statins and a non-statin drug, ezetimibe, reduces CV events. We therefore believe that the “LDL-hypothesis” has been proven; the term appears to be outdated and should be replaced by “LDL causality”.

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