Substances that are added to food to maintain or improve the safety, freshness, taste, texture, or appearance of food are known as Food additives.
One of the most important aspects for the production of nutritional supplements are the technologies and production sources to ensure their quality and safety . On a global scale, the trend for know-how clearly stands out, that food supplements are closer to medicinal products, which further distances them from standard food supplements. Therefore, quality control during production is strengthened, applying the same standards that are applied in pharmaceutical products.
Regarding the raw materials, the sources for obtaining nutritional supplements are again similar to medicines - animal, plant, mineral, microbiological cultures, and we can also obtain nutritional supplements synthetically, for example, vitamins.
On a global scale, the market for nutritional supplements is becoming more and more attractive for companies from various sectors, and pharmaceutical, biotechnology and food companies are beginning to enter it vigorously.
This naturally leads to the diversification of nutritional supplements, and numerous and varied products with mixed characteristics of food, medicinal and cosmetic products, etc., begin to appear.
The types of nutritional supplements are numerous and varied. They are classified according to many characteristics and subdivided according to the usefulness they bring, according to the demand for certain supplements, etc. Some of the most sought-after and sold supplements worldwide are the following:
Chondroprotectors - glucosamine, chondroitin, hyaluronic acid
Cardioprotectors-Lycopene, Omega-3 EMC, co-Q10
Soy isoflavonoids (resemble female sex hormones that the egg produces)
Eye protectors – lutein and zeaxanthin
Minerals – Ca and Mg
Herbs - green tea, ginkgo biloba, ginseng, garlic
Nutritional supplements according to blood type:
Blood group "A" - the organism in which the production of sugars is of the simplest type, characteristic of this blood group, has adapted to eating mostly meat. If people with blood group "0" eat more meat, they will take enough fat-soluble vitamins, vitamin C and iron, but nevertheless they should also take supplements from the Vitamin B group to avoid the negative effect of a larger amount of meat intake (arthritis)
Blood group "A" - people with blood group "A" have the genetic code of herbivores. The body of these people receives enough vitamins and minerals, but a deficiency of iron and some other vitamins may occur.
Blood group "B" - the carriers can accept all types of food and can consume larger amounts of meat than blood group "A". Only they can satisfy themselves with milk and milk products.
Blood group "AB" - they take enough vitamins and minerals, however, it is good for them to take more vitamin C, because they have a low level of stomach acidity
Markets can be subdivided according to the degree of development of:
Emerging markets - they lack a legal base and regulation, dedicated specialized distribution channels, specialized consultants and informed consumers .
Developing markets - they have basic regulation, specialized distribution and consultants, increased consumer interest and the need for more information channels .
Mature markets - precise regulation, clearly defined specialized distribution channels, medical specialists-consultants, maximally informed consumers
In emerging markets, there is a high risk in the use of dietary supplements of low utility for their consumers. The health risks in these markets are throughout the chain of production and sale of the products. In developing markets, we have a moderate risk in the use to a moderate benefit for consumers. The risks to health are significantly reduced, but still the issues with the control of sources for extracting food additives, quality control for storage, transportation, labeling control, advertising problems and the possibility of competent professional consultancy for their safe and effective use have not been solved. .In mature markets, there is the lowest risk versus the highest benefit of their use, due to the high levels of control achieved throughout the production and marketing chain.Medical professionals in these markets have a high level of competence.
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Clinical studies are the most important, as they provide a solid practical basis and evidence for the action, safety in use and effectiveness of nutritional supplements. The studies are carried out according to the rules of good clinical practice established in the study of medicinal products, namely - double-blind , placebo-controlled, crossover, randomized and multicenter studies on a sufficiently large number of people. But still too few manufacturing companies go through clinical studies and study their absorption in the human body.
The GMP certificate is a project of the National Food Additives Association in the USA. Its purpose is to contribute to greater credibility in the industry. It represents a system of rules for the production of pharmaceutical products and nutritional supplements and monitors the correct implementation of the production process so that the final result is at a high level. Its presence on a given product guarantees that all requirements are met. The certificate is a standard that emphasizes all stages of production, which are:
Way of raw material and high quality
Supplier quality systems
Use of modern technologies
Way of controlling
Hygiene of the premises
Water and air systems
Highly qualified staff
During the last few years, rapid growth rates have been noticed in the sales of nutritional supplements - between 8-10%. In the fast-moving commercial network, some types of nutritional supplements are freely sold, such as vitamins, minerals, probiotics, etc. There are also specialized alternative networks for the sale of nutritional supplements - drugstores, health and diet food stores. Network marketing has a significant share of sales, but their sales are difficult to monitor, as they do not go through the commercial network. The market is to be regulated through new regulations and directives, which are expected to be adopted by the European Union within a few years.
The problems in the market of nutritional supplements are related to the lack of sufficient resources and special bodies to control the registration, quality, safety and effectiveness of nutritional supplements, as well as advertising and information channels to reach consumers. The procedure of registration of nutritional supplements additives does not match European standards and turned out to be too liberal and high-risk compared to the old registration regime, which required laboratory tests for product quality.Facilitated and simplified admission of any type of nutritional supplements to consumers based only on the presentation of documents by the manufacturer raises the question of how objective and impartial the manufacturer can be regarding the quality and effectiveness of his own product. There is also a lack of sufficient competence and interest on the part of of specialists to this type of product. Consequently, it is not possible to provide professional consultation and assistance to users in choosing a suitable nutritional supplement.In the labeling, presentation and advertising of dietary supplements, properties to prevent, treat or cure disease are attributed or implied, as well as refer to such health-related properties. "Health claim" means a claim that states , creates the impression or suggests that there is a relationship between a given category of food, an individual food or one of its ingredients and health. "Claim to reduce the risk of developing a certain disease" means a health claim that states, creates the impression or implies that the consumption of a given category of food, an individual food or some of the ingredients, significantly reduces a certain risk factor for the development of a disease in humans.
These two claims cannot be made to nutritional supplements, they can only be made to dietary foods for special medical purposes, after the relevant operator has provided evidence of this .
- Dietary supplements are often advertised in the media, with a "health claim" or "claim to reduce the risk of developing a certain disease" being attributed to them, which misleads people that a food will have a positive effect on their health;
- The name of the food supplement is written only in Latin;
- The label of the product does not say that it is a "food supplement";
- Nutrients or substances with a nutritional or physiological effect are written on the product label, without declaring their quantities, or if they are declared, the quantities are not those that should be contained in the recommended dose of the product for daily intake;
- On the label for the manufacturer of nutritional supplements produced on the territory, companies that do not have a production site are recorded.
The gradual imposition of the concept of maintaining optimal health will continue to increase the areas of application and use of nutritional supplements, which will lead to a stable and continuous growth in their production and sales. Due to the increased expectations and requirements for nutritional supplements worldwide, it will continue to increase and guarantee their quality, effect and non-status by all possible mechanisms. Control over their sources, raw materials, extraction technologies, processing, transport, production cycle, packaging, labels, advertising and marketing practices will continue to be strengthened and will become increasingly precisely regulated. An additional contribution to this will be provided by market monitoring by independent bodies such as state and non-governmental organizations.associations of manufacturers and importers of nutritional supplements, consumer associations, medical experts and end users.
Regarding the future development of the food supplements market, what is needed in the market is the further development, unification and harmonization of Bulgarian legislation and regulatory mechanisms in accordance with the latest changes in European legislation and the best European practices.
In order for the market to quickly and successfully reach an average European level of market maturity, it is necessary to be aware of the huge benefits and significant health risks that these products hide. Targeted efforts are needed on the part of all those who carry out the activity in the market - producers, traders, healthcare specialists, consumers and government institutions, in order to guarantee maximum safe and effective use of nutritional supplements and their valuable contribution to the health status of the population.
The GMP certificate is part of the regulation of the pharmaceutical business, which is subject to similar control already in the development activity and on the way to the consumer. GMP is rarely commented on, as no original formulas are developed, and trials are conducted by well-trained teams funded by foreign companies and subject to control by the Medicines Executive Agency.
The current normative basis of GMP is the Law on Medicines and Pharmacies in Human Medicine. The inspectors do not issue a certificate, but an inspection report, in which they reflect the facts established by them in accordance with GMP and their recommendations. Sooner or later, factories that produce pharmaceutical products without strictly following GMP requirements will be closed for the safety of citizens. Achieving GMP is a condition to maintain its traditional markets and expand its sales. At the moment, the pursuit of sales in the European Union and the USA is a matter of prestige, not economic benefit. By implementing GMP , we will guarantee the quality and safety of food products.
With supplements, there is no price regulation and pharmacies are free to determine prices and promotions independently or together with the manufacturer. In this way, they choose their pricing policy and are more or less attractive than the competition. The products that appear on the market pose a danger to consumers. as food supplements, but they do not meet the regulatory requirements and have a potentially misleading purpose. These are the so-called dangerous foods. That is why it is necessary to create the same and transparent conditions for entering the market by observing precisely regulated conditions in relation to food additives, an example of such conditions is the so-called GMP certificate, which is expedient to be accepted by the Ministry of Agriculture and Food, which currently issues the regulatory documents for food additives.