Products based on essential oils are increasing their presence on the European market. Manufacturers are eager to follow high demand from consumers and are expanding their ranges with this product type as a result. In the absence of specific regulations that define a status for essential oils, manufacturers are sometimes faced with difficulties in meeting the status requirements which correspond to their product (cosmetic, foodstuff, medical device, etc.).
As a reminder: the European Pharmacopoeia defines essential oils as follows: “odorous product, usually of complex composition, obtained from a botanically defined plant raw material by steam distillation, dry distillation, or a suitable mechanical process without heating. Essential oils are most often separated from aqueous phase by a physical process that does not cause a significant change in its composition.” Thus due to its’ manufacturing processes, essential oils are very concentrated in active chemical elements. The ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé (France)) specifies that improper and uncontrolled use of essential oils comes with the risk of serious undesirable effects. Therefore, manufacturers have the responsibility to make every effort in ensuring consumer safety when using products based on essential oils.
In addition, the presentation and communication of products based on essential oils have a direct impact on the possible choices for its’ regulatory status. Last July, RNI Consulting participated in the AROMADAYS congress and presented on the topic of regulatory constraints for the use of claims in aromatherapy to date (France-Europe) for different product statuses (food supplements, medical devices, cosmetics and biocides). During recent controls (initially on cosmetics based on essential oils) carried out by the French authorities (DGCCRF), an infringement rate above 80% was discovered which was mainly linked to non-conformities of labelling and indications. The vast majority of products based on controlled essential oils did not contain any information on the status of the product and their function, leaving the consumer to decide for themselves how to use it (i.e. flavouring purposes, as a cosmetic, etc.). Nevertheless, it is essential to determine a regulatory status and only one according to the conditions of use (i.e. topical route, ingestion…) and communication (therapeutic claims, cosmetics, health…) specific to the product. This regulatory status, according to those currently existing at a community level, can be (among other things) cosmetic, medical device, food supplement or food flavoring. Rules regarding composition, labelling, and market placement built-in to each status at a community level (or sometimes completely nationally) must be respected. Hence, this regulatory compliance provides a primary level of security.
While from a regulatory point of view, the rules are relatively harmonized at a community level for cosmetics and flavorings, this is not necessarily the case for food supplements. The essential oils used as an active ingredient in these foods are no exception. It is therefore advisable to refer to Community AND national requirements to ensure the conformity of these products and consumer safety.
Overview of dietary supplements based on essential oils
Like Europe, the regulatory status of essential oils is determined by the product’s intended use (based on communication (claims), conditions of use, advertising and/or consumer perception). In the United States, essential oils are generally classified as common foodstuffs, food supplements, cosmetics or consumer products (household cleaners, scented candles, etc.). Essential oils considered as common foodstuffs, food supplements and cosmetics are regulated by the FDA (Food and Drug Administration), while consumer products are regulated by the CPSC (Consumer Product Safety Commission). These regulatory requirements must be carefully evaluated to ensure correct status choice and product conformity. This is particularly the case with allegations which, if not appropriate for the chosen status, could lead to product reclassification as a medicine or pesticide and be subject to coercive action by authorities.
Since 2007, a list of essential oils have been subject to the pharmaceutical monopoly in France. This list follows from “Decree n ° 2007-1221 of August 3rd, 2007 modifying article D. 4211-13 of the public health code relating to the list of essential oils whose sale to the public is reserved for pharmacists”. Therefore, these essential oils cannot be used in food supplements in France
Since January 2019, the DGCCRF has implemented health recommendations for the use of these active ingredients to assist the consumer with this industrial craze. This document contains the list of essential oils authorized in food supplements, factors to consider when carrying out a risk analysis and identifying the potential dangers of essential oils, as well as warnings for certain population groups (pregnant women, lactating women , children…)
The DGCCRF has added a dedicated page to their website on this : (https://www.economie.gouv.fr/dgccrf/complements-alimentaires-huiles-essentielles ) to encourage considering as many factors as possible when justifying the safety of this type of product Finally, it is also possible to partially rely on the work released by Synadiet (National Union of Food Supplements), whose work is officially recognized by the DGCCRF. Two lists are currently available on their website which group together 64 essential oils recognized as traditional in food supplements, associated with recommended doses and precautions for use. These lists are used to support the risk analysis and validate the composition of an essential oil-based formula. Thus, in France, food supplements meeting all the requirements of the European and French regulations in force for this status (Directive EC / 2002/46, Regulation EU / 1169/2011, Regulation EC / 1924/2006, French decree 2006 -352…), and the recommendations of the DGCCRF (while relying on Synadiet’s lists) ensure product safety.
Unlike France, this country does not have specific rules for the use of essential oils as active ingredients in food supplements. Nevertheless, The British authorities specify that essential oils are only authorized in food supplements for flavoring purposes. Essential oils with an active role can be considered medicinal and would therefore not be authorized in food supplements.
In conclusion, it is imperative to determine the appropriate regulatory status for your product, taking into account its function and intended mode of use. Risk analysis is important and should not be overlooked before any product containing these essential oils is placed on the market and must be appropriate with regard to the exact chemical composition of the essential oil. These factors will ensure regulatory compliance of the product as well as consumer safety.
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