**7. Commercial availability and legislation**

Some essential oils have been registered by the European Commission as flavouring agents to be used in foodstuff. In terms of legislation related to foodstuff, both the European Union (through European Food Safety Agency and its national branches) and the United States

Antimicrobial Activity of Condiments 127

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In several regions of the world traditional culinary habits and medicinal pratices use plants and herbs in daily routine. Modern conventional medicine is challenged today by the ever growing bacterial resistance to classic antibiotics. More research is necessary to ascertain the real therapeutic value of these products, but these natural resources must not be despised because

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caused by seasonal conditions, leading consequently to variable biological activity.

their clinical and economic value may be greater than has been supposed up to this day.

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**9. References** 

(through Food and Drug Administration) have been continually issuing and updating a number of regulations and list of food additives and supplements that have been authorised and considered safe for human consumption. In particular, some antimicrobial essential oils like cinnamon oil, clove oil, lemon grass oil and their respective active substances (cinnamaldehyde, eugenol and citral) have been generally recognized as safe (GRAS denomination) by the American FDA as food additives.

However, the classification of plant-based products as pharmacologically active substances or medicaments is less clear. They can only be included in foodstuff legislation if not proven as being medicaments. The main obstacle on the legal establishment of these molecules or mixtures originates from potential risks to the consumers health. The risks arise from any toxic effect, unknown to date. Several studies have to be performed on the metabolic effects, physical and chemical characterization of the molecules, microbiological studies, safety assays, and the cost of performing these experiments is high. This financial cost can be an excessive burden to small companies.

Medicaments are molecules with properties of treatment or prevention of human diseases, or with pharmacological, immunological or metabolic action. Plant-based medicaments are regulated, within European Union, by Directive 2004/24/CE. Each member country has to integrate onto their own legislation the contents of this Directive. It comprises not only antimicrobial herbs and plants, but any pharmacologically active vegetable product, in particular those utilized in Chinese traditional medicine and ayurvedic medicine. The European Commission issued it in order to establish concepts and regulate the trade. They define traditional plant-based medicaments as products, of vegetable origin, targeted to treat some illnesses, in use for at least 30 years (including 15 years of use within European Union borders) and that are to be employed without medical supervision and whose administration does not include injection or parenteral use. This usage must be proven by documentation. Some examples of species employed in the production of plant-based medicaments have already been listed along this chapter, as *Calendula officinalis*, *Echinea purpurea* or *Pimpinella anisum*.

Although being natural products (and sometimes with a long tradition of medicinal use), some of these substances may be harmful to patients and this is why European Union requires specific authorization for these products (which are included in general pharmaceutical legislation) to be placed in the market. The objective is to guarantee quality, safety and efficiency. Neverthless, taking in account the financial burden that some laboratory tests and clinical assays represent, the European Union has introduced a more simplified registration procedure without forgeting the forementioned requirements of quality, safety and efficiency. The companies that produce or trade the plant-based medicaments must present unquestionable documentation proving the innocuity to human health and the established therapeutic use (30 years of use and 15 years within European Union).
