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Drugs and Health Products

Aromatherapy — Essential Oils

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredients.

Notes

  • Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
  • The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant.
  • All claims must include the qualifier "Used in aromatherapy".

Date

December 8, 2015

Medicinal Ingredients

Refer to Appendix 1

Proper name(s), Common name(s), Source material(s), Dose(s)

Refer to Appendix 1

Route(s) of Administration

  • Topical
  • Inhalation

Dosage Form(s)

Those dosage forms suited to inhalation and/or topical administration including but not limited to liquids, oils, sprays, roll-ons.

Use(s) or Purpose(s)

Statement(s) to the effect of

Refer to last column of Appendix 1 for uses supported for each medicinal ingredient.

1.  Used in aromatherapy for symptomatic relief of acne/boils.
2.  Used in aromatherapy to relieve minor skin irritation/cuts/bruises/burns.
3.  Used in aromatherapy for symptomatic relief of eczema/dermatitis.
4.  Used in aromatherapy as a nervine/calmative.
5.  Used in aromatherapy to help relieve joint/muscle pain associated with sprain/strain/rheumatoid arthritis.
6.  Used in aromatherapy to help relieve headache.
7.  Used in aromatherapy as a carminative/antispasmodic for symptomatic relief of digestive discomfort.
8.  Used in aromatherapy to help relieve colds/cough.

Notes
  • Uses # 1, 2, 3 and 5 are for topical route of administration only.
  • Uses # 4, 6, 7 and 8 are for topical and/or inhalation route of administration.

Dose(s)

Sub population

Adults (≥ 18 years)

Quantity(ies)

Refer to Appendix 1 and/or Directions for use section below.

Ingredient Combinations

All ingredients included in this monograph may be combined together with the following restrictions:

  • For local topical application/body massage, the total concentration of the combined essential oils must not exceed 5%; and
  • Each essential oil in the product combination must not exceed its maximum concentrations listed in Appendix 1.

Directions for use

Statement(s) to the effect of

All Products
  • Not for oral use.
  • Avoid contact with eyes and mucous membranes; if this happens, rinse thoroughly with vegetable oil.
Local application (10% or less of body surface area)
  • Apply to affected area up to 3 times per day.
Body massage (more than 10% of the body surface area)
  • Apply once daily.
Essential oils requiring dilution (topical)
  • Do not use essential oils undiluted.

Note:
Directions of use explaining appropriate dilution of essential oils in carrier oil must be included on the PLA form and label (refer to Appendix 2).

Sprays used for muscle pain/other topical use
  • Rub and/or massage into skin until solution vanishes.
Bath
  • Add 2 — 8 drops of undiluted essential oil with the same amount of shampoo or liquid soap before adding it to the bath. Mix the water gently. For maximum benefit, remain in the bath for 10 minutes. Use 2 drops of undiluted essential oil the first time and increase by 1 drop per bath up to a maximum of 8 drops (Tisserand 1977; Price and Price 2007).
  • Use once daily.
Direct inhalation
  • Apply 1 — 6 drops of undiluted essential oil to a handkerchief/tissue and inhale occasionally (Price and Price 2007).
  • Up to 3 times per day.
Steam inhalation
  • Add 3 — 12 drops of undiluted essential oil to a bowl of steaming water/facial steamer. Inhale slowly and deeply for 5 to 10 minutes (Price and Price 1999; Tisserand and Balacs 1995).
  • Up to 3 times per day.
Compresses
  • Add 2 drops of undiluted essential oil to 500 ml of warm water in a bottle. Mix by shaking the bottle and immediately soak the compress. Squeeze lightly, apply the compress to the skin, and cover with clothes and/or towelling. Leave for 2 to 4 hours (Tisserand 1977).
  • Up to 3 times per day.
Notes:
  • A drop size of 0.05 ml is used for this monograph; however, drop size may vary (refer to Appendix 2).
  • Number of drops indicated above should be adjusted for pre-diluted essential oil.

Duration of use

Statement(s) to the effect of

All products

For occasional use only.

Risk Information

Statement(s) to the effect of

All products Caution(s) and warning(s):
  • Keep out of reach of children.
  • If accidental ingestion occurs, seek urgent medical attention or contact a Poison Control Center.
  • If symptoms persist or worsen, consult a health care practitioner.
  • If you have epilepsy or asthma, consult a health care practitioner prior to use (Tisserand and Young 2014).

Contraindication(s):

If you are pregnant or breastfeeding, do not use this product.

Known adverse reaction(s):

If you experience nausea, dizziness, headache or an allergic reaction, discontinue use (Tisserand and Young 2014).

Products for local application/body massage

Caution(s) and warning(s):

All products (except products that contain phototoxic essential oils; refer to Appendix 1)

Avoid exposure of applied area(s) to the sun.

Products that contain phototoxic essential oils (refer to Appendix 1)

Do not expose the applied area(s) to the sun for 24 to 48 hours after application (Kumar et al. 1992).

Contraindication(s):

Products that contain sensitizing essential oils (refer to Appendix 1)

If you have broken, irritated, or sensitive skin, do not use this product.

Storage conditions

All products

  • Child-resistant packaging/containers should be used (JC 2012).
  • Store in airtight, light-resistant container at room temperature

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the Natural and Non-Prescription Health Products Directorate Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the NHPID.

References cited

AHPA 2012: American Herbal Products Association Guidance Policies: Next link will take you to another Web siteTrade Requirement & Guidance Policy for Labeling of Undiluted Essential Oils Used Topically and Offered for Retail Sale, [Accessed 2014 July 14].

Davis P. Aromatherapy An A-Z. Saffron Walden, (GB): The C.W. Daniel Company Limited; 1997.

HC 2013: Health Canada, Natural Health Product Ingredients Database: Next link will take you to another Web siteCounterirritants. [Published 2013 July 3].

JC 2012: Justice Canada. Next link will take you to another Web siteCautionary Statements and Child Resistant Packages. Sections C.01.001 (2) to (4) and C.01.029, C.01.031 and C.01.031.2 (1). Ottawa (ON): Department of Justice Canada. [Accessed 2013 December 10].

Kumar JR, Ranadive NS, Menon A, Haberman HF. Photoinduced cutaneous inflammatory response by psoralens. Journal of Photochemistry and Photobiology 1992;14(1-2):125-137.

Lis-Balchin M. Aromatherapy Science: A guide for healthcare professionals. London (GB): Pharmaceutical Press; 2006.

Price S, Price L. Aromatherapy for Health Professionals, 3rd edition. Edinburgh (GB): Churchill Livingstone; 2007.

Tisserand RB. The Art of Aromatherapy: The healing and beautifying properties of the essential oils of flowers and herbs. Rochester (VT): Healing Arts Press; 1977.

Tisserand R, Young R. Essential oil safety: A guide for health care professionals, 2nd edition. Edinburgh (GB): Churchill Livingstone; 2014.

Valnet J. Aromathérapie, 11th edition. Paris (F): Vigot; 2001.

References reviewed

Battaglia, S. The Complete Guide to Aromatherapy. Brisbane (AU): The Perfect Potion; 1995.

Battaglia, S. The Complete Guide to Aromatherapy, 2nd ed. Brisbane (AU): The International Centre of Holistic Aromatherapy; 2004.

British Pharmacopoeia Commission. British pharmacopoeia 2013. (Vols. IV and V) London (GB): The Stationary Office; 2012.

Carson CF, Hammer KA, Riley TV. Melaleuca alternifolia (tea tree) oil: A review of antimicrobial and other medicinal properties. Clinical Microbiology Reviews 2006;19(1):50-62.

Council of Europe. European pharmacopeia. (Vol. 1). Strasbourg, France: Directorate for the Quality of Medicines & Health Care; 2010.

Price S, Price L. Aromatherapy for Health Professionals, 2nd edition. Edinburgh (GB): Churchill Livingstone; 1999.

Price S, Price L. Aromatherapy for Health Professionals, 4th edition. Edinburgh (GB): Churchill Livingstone; 2012.

Tisserand R, Balacs T. Essential oil safety: A guide for health care professionals. Edinburgh (GB): Churchill Livingstone; 1995.

United States Pharmacopeial Convention. The United States pharmacopeia - national formulary. Baltimore (MD): United Book Press; 2013.

USDA 2014. National Genetic Resources Program. Next link will take you to another Web siteGermplasm Resources Information Network - (GRIN). National Germplasm Resources Laboratory, Beltsville, Maryland.

Worwood VA. The complete book of essential oils and aromatherapy. Novato (CA): New World Library; 1991.

Appendix 1

Appendix 1

Notes:

  • All medicinal ingredients in Table 1 are steam distilled, unless otherwise stated.
  • See Appendix 3 for definitions of various preparations (i.e. steam distilled, expressed, preparation of an absolute, rectified).
  • The concentrations in Table 1 refer to final concentrations after dilution to be applied on the skin.
  • The quantity per dosage unit for undiluted (pure) essential oils should be indicated as "100 %" on the PLA form with appropriate dilution information (such as mixing XX drops of essential oil in YY mL of carrier oil) in the Directions for use section.
Table 1: Medicinal Ingredients1

Proper name(s)

(S) Sensitizing2
(P) Phototoxic3

Common name(s) Source material(s) Concentration for Topical application Min-Max massage (Max. local)%4 Acceptable Use(s)5

Table 2 footnotes

Table 2 footnote 1

The following references were consulted: Lis-Balchin 206, Tisserand and Young 2014, Price and Price 1999, Davis 1997, Valnet 2001, HC 2013.

Return to table 2 footnote 1 referrer

Footnote 2

(S) - Sensitizing: For definition see Appendix 3. Additional duration of use and risk statements are required for medicinal ingredients indicated as sensitizing (S). Refer to Risk Information section.

Return to table 2 footnote 2 referrer

Footnote 3

(P) - Phototoxic: For definition see Appendix 3. Additional risk statements are required for all medicinal ingredients indicated as phototoxic (P). Refer to Risk Information section.

Return to table 2 footnote 3 referrer

Footnote 4

This section refers to minimum and maximum concentrations after dilution for body massage (covering more than 10 % of body surface area). In cases where higher concentration is permitted for local applications (covering up to 10 % of body surface area), information is included in brackets.

Return to table 2 footnote 4 referrer

Footnote 5

Refer to Use(s) or Purpose(s) section for recommended use associated with each number.

Return to table 2 footnote 5 referrer

Abies balsamea
  • Balsam fir essential oil
  • Balsam essential oil
  • Needle
  • Twig
1 - 5(10)% 4, 5
Abies sibirica Siberian fir essential oil
  • Needle
  • Twig
1 - 2.5% 5, 8
Angelica archangelica (S, P) Angelica essential oil
  • Root
  • Seed
0.78% 4, 5, 6, 7, 8
Aniba rosaeodora Rosewood essential oil Wood 1 - 5(10)% 1, 2, 4, 6, 8
Apium graveolens (P) Celery essential oil Seed 1 - 4% 4, 5
Boswellia frereana
  • Frankincense essential oil
  • Olibanum essential oil
Stem resin 1 - 5(8)% 2, 4, 8
  • Frankincense absolute
  • Olibanum absolute
1 - 3% (absolute) 2, 4, 8
Boswellia sacra
  • Frankincense essential oil
  • Olibanum essential oil
Stem resin 1 - 5(8)% 2, 4, 8
  • Frankincense absolute
  • Olibanum absolute
1 - 3% (absolute) 2, 4, 8
Cananga odorata (S)
  • Cananga essential oil
  • Ylang ylang essential oil
Flower 1 - 2% 4
Carum carvi Caraway essential oil
  • Fruit
  • Seed
1 - 4% 7, 8
Cedrus atlantica (P)
  • Atlas Cedarwood essential oil
  • Cedarwood essential oil
Wood 1 - 5(8)% 1, 2, 4, 5, 8
Chamaemelum nobile
  • Roman chamomile essential oil
  • English chamomile essential oil
Herb top flowering 1 - 4% 4, 7
Chrysopogon zizanioides Vetiver essential oil Root 1 - 1.5% 1, 5
Cinnamomum camphora White camphor essential oil
  • Stem Bark
  • Wood
  • Branch
1 - 5(20)% 1, 2, 5, 8
Cinnamomum verum (S) Cinnamon essential oil
  • Leaf
  • Twig
1 - 5(10)% 5, 8
Cistus ladanifer Labdanum essential oil Gum 1 - 5(8)% 4, 5, 7
Citrus aurantiifolia (P) Expressed Lime essential oil Unripe fruit peel 0.7% (expressed) 1, 5, 8
Ripe fruit peel 1 - 5(15)%
Citrus aurantium (S, P)
  • Neroli essential oil
  • Bitter orange essential oil
Flower 1 - 4% 4, 6, 7, 8
  • Neroli absolute
  • Bitter orange absolute
1 - 3% (absolute)
Petitgrain essential oil Leaf 1 - 5(10)% 4, 5
Citrus bergamia (P)

Bergamot (FCF) essential oil
FCF = Furanocoumarin-free

Fruit peel

1 - 5(20)%

(expressed-rectified)

1, 2, 3, 6, 7, 8
Bergamot essential oil

0.4%

(expressed)

Citrus paradisi (P) Grapefruit essential oil Fruit peel

1 - 4%

(expressed)

4
Citrus limon (S, P) Expressed Lemon essential oil Fruit peel 1- 2% (expressed) 8
1- 5(10)%
Citrus sinensis (S, P)
  • Sweet orange essential oil
  • Orange essential oil
Fruit peel 1 - 5(10)% (expressed) 4, 7
Commiphora myrrha Myrrh essential oil Sap Resin 1 - 5(8)% 2, 3, 8
Myrrh absolute 1 - 3% (absolute)
Corymbia citriodora (S)
  • Lemon-scent gum essential oil
  • Citron-scent gum essential oil
Leaf 1 - 5(20)% 5, 6, 8
Cuminum cyminum (P) Cumin essential oil Seed 0.4% 4, 5, 7
Cupressus sempervirens
  • Italian cypress essential oil
  • Mediterranean cypress essential oil
  • Needle
  • Twig
1 - 4% 5, 8
Cymbopogon citratus (S) Lemongrass essential oil Herb top 1 - 4% 4, 5, 6, 7
Cymbopogon flexuosus (S) East Indian lemongrass essential oil Herb top 1 - 4% 4, 5, 6, 7
Cymbopogon martini (S) Palmarosa essential oil Herb top 1 - 5(8)% 4, 8
Cymbopogon nardus (S)
  • Citronella essential oil
  • Ceylon citronella essential oil
Herb top 1% 5, 6, 7
Cymbopogon winterianus (S)
  • Burma citronella essential oil
  • Java citronella essential oil
Herb top 1% 5, 6, 7
Elettaria cardamomum Cardamom essential oil Seed 1 - 4% 7, 8
Eucalyptus globulus (S) Eucalyptus essential oil Leaf 1 - 5(25)% 5, 6, 8
Eucalyptus polybractea (S) Blue mallee essential oil Leaf 1 - 5(20)% 5, 6, 8
Eucalyptus radiata (S) Narrow-leaf peppermint essential oil Leaf 1 - 5(20)% 5, 6, 8
Foeniculum vulgare subsp. vulgare var. vulgare Bitter fennel essential oil Seed 1 - 4% 2, 5, 7, 8
Foeniculum vulgare subsp. vulgare var. dulce
  • Sweet fennel essential oil
  • Roman fennel essential oil
Seed 1 - 4% 2, 5, 7, 8
Helichrysum italicum
  • Immortelle essential oil
  • Curry-plant essential oil
Herb top flowering 0.5% 1, 2, 3, 4, 5, 7, 8
Illicium verum (S) Star anise essential oil Fruit 1 - 2% 4, 5, 6, 7, 8
Jasminum officinale (S) Jasmine absolute Flower 0.7% (absolute) 4, 5, 6, 8
Juniperus communis
  • Juniper essential oil
  • Common juniper essential oil
Fruit 1 - 5(8)% 1, 2, 3, 4, 5
Laurus nobilis (S)
  • Bay laurel essential oil
  • Laurel essential oil
  • Leaf
  • Twig
1 - 2% 4, 5, 6, 8
Lavandula augustifolia (S, P) Lavender essential oil Herb top flowering 1 - 5(15)% 4, 5, 6, 7, 8
Lavandula x intermedia (S, P) Lavendin essential oil Herb top flowering 1 - 5% 4, 5, 6, 7, 8
Lavandula latifolia (S, P) Spike lavender essential oil Herb top flowering 1 - 5(8)% 4, 5, 6, 7, 8
Litsea cubeba (S) Litsea essential oil Fruit 1 - 5(8)% 7
Matricaria chamomilla
  • Chamomile essential oil
  • German chamomile essential oil
Herb top flowering 1 - 4% 1, 2, 4, 5, 6, 7
Melaleuca alternifolia (S) Tea tree essential oil
  • Leaf
  • Twig
1% 8
Melaleuca cajuputi Cajuput essential oil Leaf 1 - 4% 1, 3, 5, 8
Melissa officinalis (S) Lemon balm essential oil Leaf 0.7% 4, 7
Mentha arvensis Cornmint essential oil Twig flowering 1 - 5(8)% 1, 4, 5, 7, 8
Mentha x piperita (S) Peppermint essential oil Twig flowering 1 - 5(8)% 4, 5, 7, 8
Mentha spicata (S) Spearmint essential oil Twig flowering 1 - 4% 4, 6, 7, 8
Myristica fragrans Nutmeg essential oil Seed 1 - 2% 4, 5, 7
Myrtus communis Myrtle essential oil
  • Leaf
  • Twig
1 - 4% 1, 8
Ocimum basilicum (S) Sweet basil essential oil Herb top flowering 1 - 4% 4, 6, 7, 8
Origanum majorana
  • Sweet marjoram essential oil
  • Marjoram essential oil
Herb top flowering 1 - 4% 2, 3, 4, 5, 6, 7, 8
Pelargonium graveolens (S)
  • Rose geranium essential oil
  • Geranium essential oil
  • Leaf
  • Herb top flowering
1 - 5(10)% 8
Petroselinum crispum (P) Parsley essential oil
  • Herb top
  • Seed
1 - 2% 2, 4, 5
Pinus sylvestris (S) Scotch pine essential oil Needle 1 - 5(10)% 4, 5, 8
Piper cubeba Cubeb essential oil Seed 1 - 5(8)% 2, 7, 8
Piper nigrum Black pepper essential oil Fruit 1 - 4% 5, 6, 7, 8
Pogostemon cablin Patchouli essential oil Leaf 1 - 5(10)% 1, 2, 4, 7
Rosa x damascena
  • Damask rose essential oil
  • Rose Essential Oil
Flower 1 - 2% 2, 4, 6, 8
Rosa x centifolia
  • Provence rose essential oil
  • Rose essential oil
Flower 1 - 2% 2, 4, 6, 8
Rosmarinus officinalis Rosemary essential oil Herb top flowering 1 - 5(6.5)% 2, 5, 7, 8
Salvia lavandulifolia Spanish sage essential oil Herb top flowering 1 - 5(12.5)% 2, 4, 5, 7, 8
Salvia officinalis
  • Sage essential oil
  • Dalmation sage essential oil
Herb top flowering 1 - 5(8)% 2, 4, 5, 7, 8
Salvia sclarea
  • Clary essential oil
  • Clary sage essential oil
  • Herb top flowering
  • Leaf
1 - 5(8)% 2, 4, 5, 6, 7, 8
Santalum album (S)
  • Sandalwood essential oil
  • East Indian sandalwood essential oil
Wood 1 - 5(10)% 4, 6, 7, 8
Satureja hortensis
  • Summer savory essential oil
  • Savory essential oil
Herb top 0.5 % 5, 7, 8
Styrax benzoin (S) Benzoin essential oil Sap Resin 1 - 2% 4, 5, 7, 8
Syzygium aromaticum (S) Bud, stem only Clove essential oil
  • Bud
  • Stem
1 - 4% 5, 8
Leaf 1 - 2%
Thymus vulgaris Thyme essential oil Herb top flowering 1 - 5(8)% 1, 2, 4, 5, 8
Thymus zygis White Thyme essential oil Herb top flowering 1 - 5(8)% 1, 2, 4, 5, 8
Zingiber officinale (P) Ginger essential oil Rhizome 1 - 4% 5, 7, 8

Appendix 2

Appendix 2

Formula to calculate the number of drops of essential oil (EO) and the amount (in ml) of carrier oil. (Refer to definition and examples of carrier oils in Appendix 3 to obtain the desired concentration):

Number of drops of EO =   Desired concentration of EO (%) * Volume of carrier oil (ml)
  Volume of a drop (ml) * 100

Example:

If 1 drop = 0.05 ml:

To prepare a solution that contains 1% of essential oil, 4 drops of essential oil should be mixed with 20 mL of carrier oil.

Directions for use: Mix 4 drops of essential oil in 20 ml of carrier oil.

Note: If your drop size is not 0.05 ml, adjust the number of drops accordingly.

Appendix 3

Appendix 3

Definitions
Steam Distilled
Natural raw material is placed in or above water in a retort and exposed to steam, which carries the volatile oils into a condenser where the mixture is cooled. The oils separate from the water and can be collected (AHPA 2012).
Expressed (cold-pressed)
Used primarily to obtain citrus essential oils. The fruit is punctured and then mechanically pressed. No external heat is applied during the extraction process (AHPA 2012).
Absolute
Product of solvent extraction. A solvent is used to extract the oils from the plant material in which the product is called a "concrete" (mixture of essential oil, waxes, resins, and other lipophilic (oil soluble) plant material). A more polar solvent is added to the concrete to extract the essential oil. The alcohol is evaporated and leaves behind the absolute (AHPA 2012).
Rectified
Essential oil is purified by fractional distillation in order to remove unwanted constituents (Tisserand and Young 2014).
Sensitizing
Sensitizing essential oils can cause sensitization reaction, also known as allergic contact dermatitis, which is the usual clinical consequence of delayed hypersensitivity. Sensitizing oils cause more pronounced effect on patients with rash, dermatitis, eczema, sensitive skin and other skin conditions (Tisserand and Young 2014). These essential oils cause toxic effect after multiple applications(Lis-Balchin 2006).
Phototoxic
Phototoxic essential oils produce burns, dermatitis, etc. (phototoxic effects) when the treated skin area is exposed to direct sunlight. Phototoxic effects generally occur due to inherent furanocoumarin content (Tisserand and Young 2014).
Carrier Oil
Carrier oil is fixed oil used to dilute essential oils and absolutes before they are applied to the skin. Some of examples of carrier oils are Sweet almond oil, Grape seed oil, Sunflower oil, Apricot kernel oil, and Peach kernel oil (Price and Price 2007).