Essential Oils in Canada
In the past 30 years, aromatherapy and the use of essential oils have enjoyed a revival in modern culture. Essential oils are often intended to be multi-functional, with a variety of topical or therapeutic uses.5
As essential oils may be considered both a cosmetic and therapeutic product, they often fall between regulatory categories, causing confusion for manufacturers, sellers and even consumers. Further, essential oils are often regulated differently from country to country. In this article, we set out to explain regulations surrounding the commercial sale of essential oils in Canada.
Essential Oil Classification
In Canada, under Schedule 1, Item 2 (Extracts), essential oils are considered natural health products (NHPs) by Health Canada.1,2 NHPs are classified as products that are obtained from naturally occurring substances and are intended to help promote overall good health.3 Essential oils are derived from plants (naturally occurring substances) and may be used in aromatherapy, a form of Complementary or Alternative Medicine (CAM). NHPs are available in a wide variety of forms, and include common products such as vitamins and minerals, probiotics, Traditional Chinese Medicine (TCM) or Ayurvedic remedies.3 NHPs are generally considered low-risk and can be sold over the counter.6
Essential Oil Regulations in Canada
Essential oils are regulated by Health Canada, the national health authority in Canada.1,3 To be commercially sold in Canada, essential oils must first obtain a product license. Applications are reviewed by the National Health Products Directorate (NHPD), a smaller governing body which ensures all applications meet Canadian regulations.
The current Natural Health Products Regulations were passed on January 1, 2004. The aim of these regulations is to provide Canadian consumers with safe, natural products that are high-quality in nature.3
Pre Market Approval for Essential Oils in Canada
Health Canada requires all NHPs to have a product license to legally be sold in Canada. To receive a product license, applicants must submit an application that includes specific label requirements, provide detailed information about the product, prove the manufacturer follows good manufacturing practices and provide evidence of the product’s safety and efficacy.3
Health Canada requires evidence of both safety and efficacy to help determine if products are safe and potentially beneficial for consumer use. Evidence may be obtained from several sources, including: published scientific studies, clinical trials, traditional resources or pharmacopoeias.3 The amount of supporting evidence will depend on the unique health claims of the NHP.
In Canada, essential oils are approved for inhalation and diluted, topical application. Essential oils are not approved for oral use by Health Canada. Any therapeutic claims made for essential oils must have the qualifier ‘Used in aromatherapy’ placed before the claim.1
Once approved for a product license, an essential oil can be legally sold in Canada. The product will then receive an official eight-digit Natural Product Number (NPN) indicating it is authorized for sale.3
Scientific Research Referenced in this Article
- Health Canada. (2015, December 8). Aromatherapy — Essential Oils. Retrieved March 30, 2017 from http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=aromatherap&lang=eng
- Health Canada. (2017, January 10). Defined Organism Substance – Sweet Marjoram Essential Oil. Retrieved March 30, 2017 from http://webprod.hc-sc.gc.ca/nhpid-bdipsn/ingredReq.do?id=14333&lang=eng
- Health Canada. (2016, December 8). About Natural Health Product Regulation in Canada. Retrieved March 30, 2017 from http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php
- Health Canada. (2012, December 20). Pathway for Licensing Natural Health Products used as Traditional Medicines. Retrieved March 30, 2017 from http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/tradit-eng.php
- Myatt, A. (2005). Part two: the history and use of aromatherapy. Nursing & Residential Care, 7(8), 363-365. DOI: 12968/nrec.2005.7.8.18501
- Health Canada. (2011, January 26). Natural Health Products – Over 43,000 Products authorized for sale and growing. Retrieved March 30, 2017 from http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/nhp-evolution-psn-eng.php