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Selling Essential Oils Internationally

As essential oils become an increasingly mainstream product, new international regulations are emerging to help identify industry standards for essential oil quality, efficacy and safety. Although essential oils are often considered natural, therapeutic products, different governments may categorize or regulate the importation and sale of essential oils as a cosmetic, traditional medicine or drug.

As aromatherapy products and essential oils have only recently grown in popularity, these products may be less clearly defined in existing legislation. This may cause confusion for manufacturers, distributors, or consumers. Below, we explore the current regulations from some of the largest importing countries to help clarify legislation for companies looking to sell essential oils internationally.

Selling Essential Oils in Australia

According to the Therapeutics Act of 1989, essential oils are regulated as a ‘complementary medicine’. As defined by 1990 Therapeutic Goods Regulations, a complementary medicine has one or more active ingredient that has a well-documented use in amongst traditional health care practitioners.1,2 Dietary supplements, homeopathic preparations and Ayurveda or Traditional Chinese Medicine (TCM) products are also considered complementary medicines.2

selling oils internationally

Approximately 1800 new complementary medicines are listed on the ARTG each year.

In Australia, all medicines are regulated in a two-tiered, risk-based system. High-risk medicines, such as prescription drugs and some complementary medicines must be registered with the Australian Register of Therapeutic Goods (ARTG) and provide evidence of safety, quality and efficacy. However, most complementary medicines are only required to be listed on the ARTG as low-risk medicines, and are evaluated for quality and safety, but not efficacy.3

For an essential oil to be listed on the ARTG, a company or individual must submit an online application. Complimentary medicines that wish to be listed on the ARTG can only contain low-risk ingredients, as deemed by the Therapeutic Goods Administration.2,3

Health claims can only be for the maintenance of good health, or the ‘health-enhancement’ of non-serious conditions. The manufacturing of the product must meet specified Good Manufacturing Practices (GMP). Application sponsors must have evidence to support their health claims, although they may not be required to present it during the application process.2

Once the application is approved, products are assigned a AUST L number which is required to be displayed on the product label, similar to the Canadian NPN. Complementary medicines may be reviewed at any time for compliance.2

First time sellers who have no prior experience registering a medicine in Australia may wish to contact an Australian regulatory affairs consultant for further guidance.2

Selling Essential Oils in the United Kingdom and European Union

Similar to the United States, essential oils may be regulated depending on their intended use or if they are blended with another substance (such as vegetable oil for a massage product). Simply put, there is no one piece of legislation that can apply to all aromatherapy products.4

Essential oils are predominately used as a part of aromatherapy, and to benefit the spiritual, emotional or physical well-being of an individual. Depending on their intended use, pure essential oils (single or blends) may be regulated under the 2005 General Products Safety Regulations or Cosmetic Regulation (EC) No. 1223/2009.4,5,6 Sellers must adhere to specific label requirements depending on their classification.4

The EU Cosmetic Products Regulation (EC) No. 1223/2009 applies to all members of the EU and is enforced through Cosmetic Products Enforcement Regulations 2013 SI 1478. These synonymous regulations mandate a standard for all cosmetic products sold throughout Europe.6

If the intended use and essential oil meet the criteria of a ‘medicine’ the essential oil may be regulated by the Medicines Act/Traditional Herbal Medicinal Products Directive (THMPD).This is provided that the essential oil is completely herbal in origin (no synthetic additives), meets all Traditional Medicine criteria and the chemical quality matches the European Pharmacopoeia, if applicable.7

In 2004, a simplified registration process was introduced for herbal medicinal products. This application is specifically for products that can provide well-documented evidence of have a long history of use, (at least 30 years) including at least 15 years of use in the ‘community’. This replaced the previous registration process which took several years to complete.8

Due to recent changes in the European Union, namely the U.K. exiting, these regulations may be subject to change in the upcoming years.

Scientific Research Referenced in this Article

  1. American Herbal Products Association. (n.d.). International supplement regulations. Retrieved April 3, 2017 from http://www.ahpa.org/Resources/Regulations/International.aspx
  2. Australian Government: Therapeutic Goods Administration. (2013, March 25). An overview of the regulation of complementary medicines in Australia. Retrieved April 3, 2017 from https://www.tga.gov.au/overview-regulation-complementary-medicines-australia
  3. Australian Government: Therapeutic Goods Administration. (n.d.). Medicines and TGA classifications. Retrieved April 3, 2017 from https://www.tga.gov.au/medicines-and-tga-classifications
  4. Aromatherapy Trade Council. (2013, January). Aromatherapy Products and UK Regulations [PDF]. Retrieved April 3, 2017 from http://www.apnt.org/cmsAdmin/uploads/Aromatherapy_products_regulatory_position_Updated_January_2013.pdf
  5. European Directorate for the Quality of Medicines & HealthCare of the Council of Europe (EDQM). (2016). Guidance on essential oils in cosmetic products [PDF]. Retrieved April 3, 2017 from https://www.edqm.eu/en/guidance-essential-oils-cosmetic-products – View reference
  6. Medicines & Healthcare products Regulatory Agency. (2016, March). A guide to what is a medicinal product [PDF]. Retrieved April 3, 2017 from https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/506397/a_guide_to_what_is_a_medicinal_product.pdf
  7. Committee on Herbal Medicinal Products. (2016, September 20). Regulatory Q&A on herbal medicinal products [PDF]. Retrieved April 3, 2017 from http://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/03/WC500104038.pdf
  8. European Commission. (n.d.). Herbal medicinal products. Retrieved April 3, 2017 from http://ec.europa.eu/health/human-use/herbal-medicines_en
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