Essential oils are comprised of hundreds of natural chemical compounds and are widely used in industries such as pharmaceuticals, flavouring, fragrance and aromatherapy because of their characteristics and properties. Considering the emphasis on safety for chemical uses, essential oils are regulated across the nations. It is advisable to have knowledge and compliances with regulations for essential oils for hassle free use and trade of essential oils.
In USA, essential oils are regulated by U.S. Food and Drug Administration (FDA) depending upon marketed or intended uses. Essential oils may be categorised as cosmetics, drugs or cosmetics and drugs both.
Essential oils in Europe Union are regulated under REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals).
REACH is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry.https://echa.europa.eu/regulations/reach/understanding-reach
Packaging and Labelling of essential oils are regulated under Classification, Labelling and Packaging (CLP) Regulation ((EC) No 1272/2008). The regulation is based on the United Nations’ Globally Harmonised System (GHS) and its purpose is to ensure a high level of protection of health and the environment, as well as the free movement of substances, mixtures and articles.
Essential oils are classified as natural and chemical substances, or better known as Natural Complex Substance (NCS). Other substances included as NCS are concretes and absolutes, oleoresins and resinoids, CO2 extracts, infusions and alcoholic extracts.
NCS are listed on ELINCS (European List of Notified Chemical Substances) under a generic heading and considered as UVCB, substances of Unknown or Variable Composition, Complex Reaction products or Biological materials.
Some NCS can also be qualified as a mono- or multi-constituent substance depending upon their composition. More specifically, NCS are classified as UVCB sub-type 3, which are named and identified by their botanical source and process. NCS are identified based on the following parameters.
In this regard, certain rules are to be followed in consideration of identification and naming of substances in a safety data-sheet under REACH and on the labelling of substances and mixtures containing them under the CLP.
Each of the essential oil is identified with a particular EINECS (European Inventory of Existing Commercial Chemical Substances) as per ELINCS.
In the United States, NCS are identified according to CASRN or CAS Registry Number. CASRN is a unique numerical identifier assigned by the Chemical Abstracts Service (CAS) to every chemical substance described in the open scientific literature.
Composition can also affect the hazard classification of the substance under CLP.
In EU, CLP regulation, based on Globally Harmonised System (GHS), are followed in relation to classification, labelling and packaging of substances and mixtures. Under CLP regulations, essential oils are classified as Dangerous Goods. “Dangerous Goods” refers to dangerous substances that are properly packed and labeled for storage and transport by road, rail, sea, or air.
However, probably for historical reasons, the transport of dangerous goods is divided in nine classes only and essential oils are classified under Class 3.
As per GHS, each Dangerous Goods is to accompanied with Material Data Safety Sheet (MSDS) as per ISO standards and/or REACH regulations. The following topics must be covered in MSDS as per REACH regulations.
Those dangerous substances for which the international regulations for transport of dangerous goods apply have to be transported only in UN-approved container.
In addition to the correct selection of the packing, the CLP regulations and the guidelines for the transport of dangerous goods require labelling of each piece of packing piece together with “H” (hazard) and “P” (precautionary) statements.
These statements must be given in English and national language(s) together with labels of pictograms according to the classification of the potential hazard emanating from the substance. In addition, if applicable, it should also contain the label/ pictogram “environmentally hazardous”.
For transport by air, as per IATA regulations, this new label is also compulsorily required for goods with the UN numbers UN 3077 and UN 3082—it may, however, also be fixed in those cases where it is required for the transport by other carriers.
For the transport of small quantities of hazardous substances, exceptions/exemptions exist that allow simplified procedures in two levels: the “excepted quantity” and the “limited quantity.”
In the article, we have tried to provide a brief overview of the regulations related to handling and transportation of essential oils. This will help you get started. We suggest you to consult a professional for further details.
Handbook of Essential Oils: Science, Technology, and Applications