|Year : 2022 | Volume
| Issue : 1 | Page : 7-12
Regulatory frameworks for a safe and effective use of essential oils: A critical appraisal
Farah Naja1, Rena Hamadeh2, Mohamad Alameddine3
1 Department of Clinical Nutrition and Dietetics, College of Health Sciences, Research Institute of Medical & Health Sciences (RIMHS), University of Sharjah, Sharjah, United Arab Emirates; Department of Nutrition and Food Sciences, American University of Beirut, Beirut, Lebanon
2 Department of Nutrition and Food Sciences, American University of Beirut, Beirut, Lebanon
3 Department of Health Service Administration, College of Health Sciences, University of Sharjah, Sharjah, United Arab Emirates
|Date of Submission||27-Sep-2021|
|Date of Decision||19-Dec-2021|
|Date of Acceptance||22-Dec-2021|
|Date of Web Publication||19-Jan-2022|
Department of Clinical Nutrition and Dietetics, College of Health Sciences, University of Sharjah, Sharjah.
United Arab Emirates
Source of Support: None, Conflict of Interest: None
The safe and effective use of essential oils (EOs) will only be fully realized when coupled with supportive regulatory frameworks ensuring the safety, quality, and efficacy of these oils. The aim of this short communication was to present a critical appraisal of existing regulations governing the use and production of EOs, within the health and therapeutics, food industry, and cosmetics sectors. Although few regulations target the use of EOs in cosmetics, more structured regulatory frameworks exist within the health and therapeutics, and food industry domains. To that end, the main international entities involved in the regulation of EOs within these sectors are the World Health Organization and the Food and Agricultural Organization. As for the production of EOs, the International Organization for Standardization has set standard specifications for the derivation, characterization, packaging, labeling, and storage of EOs. Although existing regulations address important dimensions related to the production and use of EOs, a comprehensive and harmonized outlook on their regulations would be necessary to ensure their safe integration in the various industries. Such regulations ought to be informed by the important advances in the chemical and biological research unraveling the versatile and complex characteristics of these oils.
Keywords: Cosmetics, essential oils, food industry, health, regulation, safety
|How to cite this article:|
Naja F, Hamadeh R, Alameddine M. Regulatory frameworks for a safe and effective use of essential oils: A critical appraisal. Adv Biomed Health Sci 2022;1:7-12
|How to cite this URL:|
Naja F, Hamadeh R, Alameddine M. Regulatory frameworks for a safe and effective use of essential oils: A critical appraisal. Adv Biomed Health Sci [serial online] 2022 [cited 2022 Aug 18];1:7-12. Available from: http://www.abhsjournal.net/text.asp?2022/1/1/7/335725
| Introduction|| |
Essential oils (EOs) are complex mixtures of terpenes and phenylpropanoid compounds, present in many species of aromatic plants. These oils are, generally, extracted using steam distillation, solvent extraction, or supercritical fluid extraction . The use of these oils is versatile and extends from simple ingredients in perfumery and cosmetics to additives to both animal feed and human food and beverages to be included in more medical and therapeutic agents such as antimicrobial, analgesic, sedative, anti-inflammatory, spasmolytic, and locally anesthetic remedies . In recent years, the use of EOs has increased significantly mainly due to the increased demand of consumers for products that are natural, not processed, organic, and do not contain synthetic chemicals . Such popularity was reflected by the growing market for the EOs, which was estimated at 247.08 kilotons in 2020 and is projected to grow at a compound annual growth rate of 7.5% from 2020 to 2027 . In the year 2025, the global market of these oils is estimated to reach 16.2 billion dollars .
Concomitant to the increasing demand for EOs was a rising interest in the scientific community to explore the various aspects of EOs. This interest spanned many fields including but not limited to chemistry and biochemistry, biology, phytochemistry, physiology, and clinical studies. Although much remains to be unraveled around these oils, the recent advances in scientific research brought about a clearer understanding of the biosynthesis of EOs, their active compounds, and the respective activity in vitro and in vivo as well as application in various industries.
The growing interest in EOs coupled with advances in scientific research exploring the various aspects of these oils triggered the need to regulate their production and ensure their safe and effective usage. Although the legislative controls did not evolve around a structured and regulated model, there have been international and national attempts to regulate the use of EOs in various sectors such as health, food, and cosmetics. In this article, we present an overview of existing rules and regulations that govern the use and production of EOs.
| Regulations of the use of eos|| |
Regulations of essential oils for the use in health and therapeutics
The popularity of EOs as self-care natural medicine therapies has recently gained momentum,  with some studies reporting prevalence of use as high as 70% . Such high prevalence could be driven by the growing interest of consumers in natural ingredients and their concern about potentially harmful synthetic products [8-10].
The recent literature has witnessed a plethora of studies aiming to evaluate the effects EOs on many health conditions, including stress and depression,  surgery pain,  and other diseases such as Alzheimer, cardiovascular diseases, cancer, and labor pain in pregnancy [13-17]. In vitro and in vivo experiments have shown significant antioxidant, antimicrobial, anxiolytic, spasmolytic, or anti-inflammatory effects for several EOs [18,19]. The results of these studies offer a promising ground for the integration of EOs in drug therapy. Given the complexity of their chemical composition and their possible interactions with pharmacological agents, it remains a challenge to reach conclusive evidence in regards to the health effects and to identify the molecular pathway of the action of EOs . The interest in the health implications of EOs use has been faced with concerns around their safety including, toxicity, and side effects. Among those concerns were skin irritation, photosensitivity, and airway irritation, with some reports even linking them to pre-pubertal gynecomastia and seizures [21-28]. The increasing prevalence of the use of EOs, their perceived benignity, the possible risk of adverse reactions and toxicity, and the limited scientific evidence supporting their use are all factors of public health concern as they might jeopardize the safety and wellbeing of their users . Therefore, there is an eminent need for policies and regulations to ensure safe and effective use by the public. Such policies and regulations are a foundational step toward the successful integration of EOs into health-care systems .
At the international level, the World Health Organization (WHO) is the main regulatory body for the safe use of EOs. It works with governments of various countries to develop and implement regulations and strategies to ensure the safe use of EOs at the global level. In this context, the WHO undertook three main activities that can assist member states in fostering the safe use of plant-derived products. First, WHO hosts a digital platform (WHO essential Medicines and Health Products Information Portal) that addresses the safety of plant materials, including EOs. The portal includes 5480 medicines and health products and is updated monthly. Second, the WHO published the guidelines of the “Good Manufacturing Products” (GMP) for herbal medicines. Lastly, the WHO issued four volumes entitled “the WHO monographs on selected medicinal plants” to provide scientific information on the safety, efficacy, and quality of EOs.
In addition to the WHO recommendations, many countries have also taken additional measures to regulate the use of EOs. For instance, the Food and Drug Administration (FDA) in the United States of America periodically reviews these oils for safe and effective use. A regularly updated online platform lists all the EOs that are generally recognized as safe for their intended use, as per the FDA (Title 21, section 182.20) . In Canada, the Food and Drugs Act  and the Natural Health Product Regulations  by the Natural and Non-prescription Health Product Directorate (NNHPD) are the regulatory bodies in the country responsible to control the use of EOs. In brief, to be legally sold in Canada, EOs must obtain a product license. For the latter, detailed information about the EOs, including medicinal ingredients, source, dose, potency, nonmedicinal ingredients, and recommended use(s), must be submitted to and assessed by Health Canada . In Japan, EOs indicated as drugs/quasi-drugs are strictly controlled under national acts such as the Pharmaceutical Affairs Act and Food Sanitation Act . Under this act, importers of EOs must obtain, similar to the Canadian regulatory system, a primary license from the Minister of Health, Labour and Welfare . Many developing countries are lagging behind in building their capacity and formulating their own regulations for managing chemicals soundly. Hence, it is recommended that those countries are supported through bilateral/multilateral development agreements with donor countries to support the building of their infrastructure in that regard.
Regulations of the use of essential oils in the food industry
The application of EOs in the food industry can largely be classified under two main categories: Food flavorings and food preservatives. EOs have long been appreciated for their aromatic and flavoring qualities. Oils such as peppermint, lemon, and orange are commonly used to flavor desserts, candies, and chocolates. Other herbal oils, such as thyme and marjoram, are better suited for flavoring savory foods such as stews and sauces. Lavender and bergamot oils have become popular in chocolate crafting . As food preservatives, EOs have received increasing attention mainly due to consumers’ demand for safe and natural food products, free from synthetic chemical preservatives and minimally processed, with a longer shelf life. The application of EOs for shelf-life extension in foods is primarily due to their antioxidant and antimicrobial properties . The latter application of EOs is especially relevant in light of the increasing resistance of microorganisms to conventional chemicals and drugs . Another use of EOs related to their antimicrobial properties is related to pest management. The volatile oils and their constituents are currently being researched for weed and pest control and could be considered as an important source of lead molecules in agriculture . Whether used for flavoring or preservation of the food, all EOs ought to be listed on the “List of Ingredients” on the food label.
In the context of the application of the EOs in the food industry, the WHO with the Food and Agriculture Organization (FAO) established the Joint FAO/WHO Expert Committee on Food Additives (JECFA). The mandate of JECFA is to evaluate the safety levels of food additives, including EOs. This information is accessible to the public and is searchable online using the committee’s website. Furthermore, and among its activities related to EOs, FAO released a publication entitled “Food and Agricultural Legislation” (FAOLEX) to provide information on treaties, laws, regulations on food, agriculture, and plant sources from all countries around the globe. In Europe, the Flavoring Regulation Act (Regulation (EC) No 1334/2008) regulates the addition of EOs to food as flavoring agents and states that these oils should not be added to food in amounts greater than a set limit, as according to this regulation, these oils fall under the category of “biologically active substances”.
Regulations of the use of essential oils in the cosmetics industry
Due to the pleasant odor of many EOs, these compounds became widely used in cosmetics, perfumes, and related household products. Approximately 300 EOs produced from 3000 different plant species are commercially available and used in the fragrances’ market . The most common of these EOs are orange, corn mint, citronella, eucalyptus, peppermint, and lemon . Within the cosmetic industry, EOs are mainly used in skincare for two of their characteristics: fragrance and antimicrobial effects . The use of EOs in cosmetic is generally considered safe and nontoxic as it is used in small amount. Therefore, there is little regulation for the use of EOs in the cosmetic industry. According to the FDA, there is no regulatory definition for EOs and the use of these oils in fragrances and cosmetics does not require FDA approval before they are marketed. This exemption of FDA approval is conditional that these oils must be safe for consumers when they are used according to labeled directions, or as people customarily use them .
That said, certain EOs may cause skin sensitivity and irritations, with a few reports in the literature indicating that EOs and their compounds may possess an allergenic potential . In fact, certain EOs may contain adulterants or contaminants that may cause allergic contact dermatitis. Furthermore, the oxidation of EOs’ constituents can increase risk of skin reactions because the oxides and peroxides formed are more reactive . To minimize the risk of adverse effects associated with the use of EOs in cosmetics, the International Fragrance Association (IFRA) defined which EOs and which of their components represent a potential allergy risk. IFRA also determined the maximum concentration of EOs in order to produce safe cosmetic products .
Compared to food products and drugs, the regulation process for EOs in cosmetics is rather more lenient. As a result, the cosmetics’ private sector has an important responsibility to provide high-quality products, and to keep the consumer informed about the various EOs in their products .
Regulations of the production of essential oils
Besides the control over the use of EOs in various industries, a few international entities have developed certain regulations concerning the production of these oils. At the International Organization for Standardization (ISO), the ‘technical committee 54’ addresses the standard specifications for EOs, mainly in what relates to derivation, characterization, packaging, labeling, and storage. ISO has established over 100 standards for EOs .
Furthermore, in relation to the production of EOs, there has been a mounting concern with regard to its effect on the environment. It is arguable that EO industries pause a heavy burden on environmental resources, given the fact that large amounts of the plant are needed for their production. For instance, 250 pounds of lavender and 625 pounds of rose petals are needed to make 1 pound of their respective EO . Also related to the effect of EOs production on environmental sustainability, the global community has instilled a regulation aiming to protect endangered plant species, under the Foreign Exchange and Foreign Trade Act, based on the Convention on International Trade in Endangered Species of Wild Fauna and Flora . The latter restricts or prohibits the importation of certain endangered plant species. For example, the EO of musk, which is obtained from the abdomen of musk deer, and the Brazilian rosewood oil are subject to this act.
| Conclusions and recommendations|| |
The growth opportunity for EOs’ industry is on the rise across the globe. This is influenced by consumer demand for these oils in various sectors, including health, food, and cosmetics. The regulations of the EOs depend largely on their intended purpose of use. Globally, the WHO is the main regulatory body for use of EOs for health and therapeutics. In the food industry, the WHO together with FAO set the safety levels for their use either as food flavorings or preservatives. As for the use in the cosmetic industry, few regulations exist.
Available regulatory frameworks for EOs, as described in this manuscript, each focus on one aspect of their production or use, however, given the versatility and diverse applications of these oils, a comprehensive consideration of the various elements to be considered for the proper regulation of these oils is warranted, as outlined in [Figure 1].
Such a framework would address, in addition to the various industries where EOs are used, their production and consumption by the end-user. Some of the indirect factors that ought to be taken into consideration in formulating the legislations for EOs relate to economic profit, the cultural context, market need, and supply dynamics, involvement of the health-care professionals, as well as beliefs and perceptions. The harmonization of existing legislations among the various sectors, which include the end-user, as well as the indirect factors affecting the use and production of EOs, is needed to foster the responsible production and marketing of these oils . As outlined in the proposed framework, the individual professions, such as chiropractors, osteopaths, herbal medicine experts, have an important role to play in promoting the safe and effective use of EOs. This role could be reinforced by the syndicates, orders, credentialing, and continuing education regulatory bodies of these professions. It is noteworthy that at the core of any regulatory attempt for EOs is the evidence base and the rigorous scientific investigations to establish their quality, safety, and efficacy . Lastly, the regulatory frameworks of EOs ought to be informed and updated according to the important advances in the chemical and biological research unraveling the versatile and complex characteristics of these oils. Tight coordination among the science, evidence and regulations is warranted in order to ensure safe and effective use of EOs.
The authors would like to thank Dr. Reyad Rashid Shaker Obaid for his critical evaluation of this manuscript.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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