**6. Legal aspects of the herbal extracts use in foods and safety data**

The new Regulation (EC) N°1334 of the European Parliament and of the Council on flavorings and certain food ingredients with flavoring properties for use in and on foodstuffs entered into force in 2009 [138].

The new Regulation stipulates new labeling requirements for both flavoring manufacturers and (final) food manufacturers. These include labeling as "natural flavoring substance(s)" may only be used for flavorings where the flavoring part contains exclusively natural flavoring substances.

The risk management of certain substances naturally present in certain food ingredients with flavoring properties (e.g. herbs, spices) and/or flavorings is based on the "major contributor approach": maximum levels are established for the presence of these undesirable substances in food, which contribute most to the human intake of these substances.

European Commission has been registered numerous herbal extracts' components for use as flavorings in foodstuffs. The flavorings registered are considered to present no risk to the health of the consumer and include, among other, carvacrol, carvone, cinnamaldehyde, pcymene, eugenol, limonene, menthol, and thymol.

New flavorings may only be evaluated for registration after carrying out serious toxicological and metabolic studies, which could require a considerable financial expense. Also, the legislative is different in different countries, for example, estragole and methyl eugenol were deleted from the European Commission list in 2001 due to their being genotoxic. However, since today, estragole is on the EAFUS (Everything Added to Food in the United States) list. The EAFUS list is a list of substances that the United States Food and Drug Administration (FDA) has classified the as generally recognized as safe (GRAS) or as approved food additives.

Till today, many researchers found that a significant number of herbal extracts' components are GRAS and/or approved food flavorings. However, some research data indicate irritation and toxicity: cinnamaldehyde, carvacrol, carvone, and thymol appear to have no significant effects in vivo, whereas in vitro they exhibit mild-to-moderate toxic effects at the cellular level [20]. Also, it was found that eugenol, menthol, and thymol, when applied in root canal treatments, could cause irritation of mouth tissues [144]. Some oils used in the fields of medicine, paramedicine, and aromatherapy have been shown to exhibit spasmolytic or spasmogenic properties [145].
