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Essentials Oils: Cosmetic or NHP?

When it comes to topical essential oils, determining the correct regulatory pathway to ensure full compliance typically depends on how you wish to market the product. Do you intend your essential oil to be diluted and worn as a blissfully scented fragrance oil, or do you intend for the product to be used to help relax the consumer and offer some relief for that headache he or she has had all day? If you chose the former, then you can market your product under the Canadian cosmetic framework. If you choose the latter, then your product must be regulated as a Natural Health Product (NHP) in Canada.

The main difference between the manner in which cosmetics and topical NHPs are regulated often comes down to marketing. NHPs are required to carry a health claim on their labels whereas cosmetics are not permitted to make health claims. In the example above, the fragrance oil is considered a cosmetic, while the oil used for relaxation and headache relief is an NHP. It is important to note, that these 2 products (i.e. the cosmetic and the NHP) can be identified in the formulation and yet regulated via 2 different regulatory pathways in Canada. It typically comes down to the intended use of the product.

Health Canada defines aromatherapy as “a branch of botanical medicine which uses essential oils and other volatile/aromatic plant extracts for therapeutic or medicinal effect”. If you are looking to market your essential oils for their therapeutic purposes, the Natural and Non-Prescription Health Products Directorate (NNHPD) has published an aromatherapy monograph outlining the specific therapeutic indications of various commonly used essential oils. While this is an excellent resource, applicants are always permitted to submit their own evidence to support indications or oils which may not be present in the monograph.

If the therapeutic properties of the oil are not important to your marketing strategy, you may wish to consider marketing the essential oil as a cosmetic. Going the cosmetic route avoids some regulatory hurdles, such as product licensing and site licensing. To achieve compliance for a cosmetic, you require a compliant label and submission of a cosmetic notification to Health Canada within 10 days after the product is introduced into the Canadian market.

But wait! Isn’t there a third option for essential oils? If you are looking to sell your essential oils for use with a diffuser, then your product would be classified as either a consumer product or an NHP, depending on whether you wish to market the product for its health benefits. If the product is meant to be used only to add a pleasant aroma to any room, the product would be considered a consumer product. As discussed above, if the oil is intended to be diffused for use in aromatherapy, it would require licensing as an NHP prior to market access.

If you are interested in marketing essential oils in Canada, Quality Smart Solutions has a team of specialists who can assist you in determining the correct regulatory pathway for compliant market access.  Contact us today to discuss how we can be your solution!

Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for 10 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Medical Devices, OTC drugs and canna. Ask us for details or visit our website at www.qualitysmartsolutions.com.

How We Can Help

Our Experts at Quality Smart Solutions also offer to support your needs for foods, cosmetics, OTC drugs and medical devices for North America.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

30 Minutes Free Consultation

Resources:

Aromatherapy — Essential Oils. December 8, 2015. http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=aromatherap&lang=eng

Canada Consumer Product Safety Act (S.C. 2010, c. 21). May 23, 2018. http://laws-lois.justice.gc.ca/eng/acts/C-1.68/

Cosmetic Regulations (C.R.C., c. 869). June 14, 2007. http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._869/index.html

Pathway for Licensing Natural Health Products Making Modern Health Claims. December 2012. https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/pathway-licensing-making-modern-health-claims.html

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Why EFSA’s Role as a Regulatory Authority is Important to Us

The European Food Safety Authority (EFSA) is a world renowned regulator which is known for its high scientific standards when it comes to food safety and claim substantiation. Formed in 2002 following several mishaps involving food safety, EFSA is responsible for the evaluation of scientific evidence and identification & communication of risks pertaining to safe practices in the areas of food & nutrition, animal feeds, animal health, plant protection and plant health.

Why are EFSA’s methods and findings important?

EFSA uses high level scientific evaluation to formulate their opinions. While some may argue their findings are only applicable to the European market, this is not entirely true. EFSA’s regulatory opinion is valued in many other jurisdictions. For example, in December of 2015 the Canadian Food Inspection Agency (CFIA), Canada’s science-based regulator of food, animals and plants, officially agreed to collaborate with EFSA for the collection, analysis and sharing of data pertaining to risk assessments. Both regulatory bodies also agreed to share views and expertise on methods for data collection, risk assessment and risk communication. Further to this, EFSA’s assessments are also highly regarded by regulatory officials at Health Canada. If you have obtained EFSA approval for a food ingredient or a health claim, it is likely that your evidence will be approved by Health Canada as well.

While it is up to EFSA’s team of experts to formulate the final opinion, they seek comments from stakeholders prior to finalization of their reports. Of particular interest to our industry is their current consultation. They are currently seeking consultation for the Guidance on the Requirements for Health Claims Related to Physical Performance.  This draft guidance outlines EFSA’s current view on the evidence required to support claims on muscle function, physical performance and physical capacity. The consultation is open until September 2, 2018 and comments are welcome from any interested party, but please note comments will be made public.

If you are marketing a workout supplement in Canada, the United States or Europe, EFSA’s draft guidance document is worth a read. If the evidence you have on file aligns with the final published views of EFSA, it is likely your claims will be substantiated. This is beneficial for your Canadian products since it will help facilitate the approval of your innovative natural health products geared to support muscle function & physical performance.

EFSA’s opinions may also benefit your American dietary supplements. If the evidence you have on file to substantiate your clear and meaningful claims matches that required for European approval, then it is likely that you have competent and reliable scientific evidence to render your health claims truthful and not misleading.

If you are interested in bringing a workout supplement to Europe, Canada or the United States, or if you would like to submit anonymous comments to EFSA on their draft Guidance on the Requirements for Health Claims Related to Physical Performance, Quality Smart Solutions has a team of specialists who can assist you.  Contact us today to discuss how we can be your solution!

Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for 10 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Medical Devices, OTC drugs and Canna. Ask us for details or visit our website at www.qualitysmartsolutions.com.

How We Can Help

Our Experts at Quality Smart Solutions also offer to support your needs for foods, cosmetics, OTC drugs and medical devices for North America.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

30 Minutes Free Consultation

Resources:

European Food Safety Authority. Public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance (revision 1). 16 July 2018. https://www.efsa.europa.eu/en/consultations/call/180716-0.
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