Safety evaluation, essential oils

The evaluation of the safety of essential oils that have a documented history of use in foods starts with the presumption that they are safe based on their long history of use over a wide range of human exposures without known adverse effects. With a high degree of con dence, one may presume that essential oils derived from food are likely to be safe. Annual surveys of the use of avoring substances in the United States (NAS, 1965, 1970, 1975, 1981, 1987 Lucas et al., 1999 Harman et al, 2013 21 CFR 172.510) in part, document the history of use of many essential oils. Conversely, con dence in the presumption of safety decreases for natural complexes that exhibit a signi cant... 

The safety evaluation of flavoring substances provides a unique challenge to regulators due to their large number and their generally low level of use. In addition, many flavoring substances occur in natural products (i.e., extracts, oleoresins, and essential oils) and have a long history of safe use. 

There is scant evidence that Manuka (Leptospermum scoparium) and Kanuka (Kunzea ericoides) have such potential, but as the essential oils are said to have remarkable powers of healing, based on folk medicinal usage. These oils are being used by some aromatherapists, although there have been no safety or toxicological evaluations performed on them. 

Different toxicity tests were conducted to evaluate safety of Saro essential oil. These include primaiy eye tolerance tests, cytotoxicity and mutagenity potential. Each test was conducted in compliance with the Principle of Good Laboratory Practice regulation by internationally recognized laboratories. 

For mutagenic activity, the risk of carcinogens and mutagens compounds which might be presented in the oil was also evaluated according to the international guidelines (OECD 471 and commission directive N° B13/14). Tests have been conducted at the CIT (International Center of Toxicity) Safety and Health Research Laboratories, 27005 Evreux, France. This test evaluates the potential of the Saro essential oil to induce reverse mutation in Salmonella typhimurium, knowing that the bacterial reverse test is able to identify substances that cause point mutations, by affections of DNA base-pairs (19, 20). Five strains of S. typhimurium TA 1535, TA 1537, TA 98 TA 100 and TA 102 were supplied for the study by B.N. Ames Laboratory (University of California, Berkeley or Oakland Research Institute, USA). 

Guide and Example for the Safety Evaluation of Essential Oils.240... 

Routinely, the daily PCI of the essential oil is derived from the annual volumes reported in industry surveys (NAS, 1965, 1970,1975,1982,1987 Lucas et al., 1999 JFFMA, 2002 EFFA, 2005). If a conservative estimate of intake of the essential oil is made using a volume based approach such that a de ned group of constituents are set for each essential oil, target constituents can be monitored in an ongoing quality control program, and the composition of the essential oil can become one of the key sped cations linking the product that is distributed in the marketplace to the chemically based safety evaluation. 

Limited speci cations for the chemical composition of some essential oils to be used as food avorings are currently listed in the Food Chemicals Codex (FCC, 2013). For instance, the chemical assay for cinnamon oil is given as not less than 80%, by volume, as total aldehydes. Any speci cation developed related to this safety evaluation procedure should be consistent with... 

GUIDE AND EXAMPLE FOR THE SAFETY EVALUATION OF ESSENTIAL OILS... 

In Step 1, essential oils are prioritized according to their presence or absence as components of commonly consumed foods (Step 1). This question evaluates the relative intake of the essential oil as an intentionally added avoring substance versus its intake as a component part of food. Many essential oils are isolated from plants that are commonly consumed as a food. Little or no safety... 

In Steps 5,6, and 7, each congeneric group in the essential oil is evaluated for safety in use. In Step 5, an evaluation of the metabolism and disposition is performed to determine, under current conditions of intake, whether the group of congeneric constituents is metabolized by well-established detoxication pathways to yield innocuous products. That is, such pathways exist for the congeneric group of... 

In the event that insuf cient data are available to evaluate a congeneric group at Step 7, or the currently available data result in margins of safety that are not suf cient, the essential oil cannot be further evaluated by this guide and must be set aside for further considerations. 

The safety evaluation of an essential oil is performed in the context of all available data for congeneric groups of identi ed constituents and the group of unidenti ed constituents, data on the essential oil or a related essential oil, and any potential interactions that may occur in the essential oil when consumed as a avoring substance. 

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