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 statements are synonymous. Either term or statement may be selected by the applicant.
All claims must include the qualifier "Used in aromatherapy".

Date

September 29, 2022

Proper name(s), Common name(s), Source information

Table 1. Proper name(s), Common name(s), Source information
Proper name(s)	Common name(s)	Source information
Proper name(s)	Common name(s)	Source material(s)	Part(s)
Abies balsamea	Balsam essential oil Balsam fir essential oil	Abies balsamea	Needle Twig
Abies sibirica	Siberian fir essential oil	Abies sibirica	Needle Twig
Angelica archangelica	Angelica essential oil	Angelica archangelica	Root Seed
Aniba rosaeodora	Rosewood essential oil	Aniba rosaeodora	Wood
Apium graveolens	Celery essential oil Celery seed essential oil	Apium graveolens	Seed
Boswellia frereana	Frankincense essential oil Olibanum essential oil	Boswellia frereana	Stem resin
Boswellia frereana	Frankincense absolute Olibanum absolute	Boswellia frereana	Stem resin
Boswellia sacra	Frankincense essential oil Olibanum essential oil	Boswellia sacra	Stem resin
Boswellia sacra	Frankincense absolute Olibanum absolute	Boswellia sacra	Stem resin
Cananga odorata	Cananga essential oil Ylang ylang essential oil	Cananga odorata	Flower
Carum carvi	Caraway essential oil	Carum carvi	Fruit Seed
Cedrus atlantica	Atlas cedarwood essential oil Cedarwood essential oil	Cedrus atlantica	Wood
Chamaemelum nobile	English chamomile essential oil Roman chamomile essential oil	Chamaemelum nobile	Herb top flowering
Chrysopogon zizanioides	Vetiver essential oil	Chrysopogon zizanioides	Root
Cinnamomum camphora¹	Camphor essential oil White camphor essential oil	Cinnamomum camphora	Branch Stem Bark Wood
Cinnamomum verum	Cinnamon essential oil	Cinnamomum verum	Leaf Twig²
Cistus ladanifer	Labdanum essential oil	Cistus ladanifer	Gum
Citrus aurantiifolia	Lime essential oil	Citrus aurantiifolia	Unripe fruit peel Ripe fruit peel
Citrus aurantium	Bitter orange essential oil Neroli essential oil	Citrus aurantium	Flower
Citrus aurantium	Bitter orange absolute Neroli absolute	Citrus aurantium	Flower
Citrus aurantium	Petitgrain essential oil Petitgrain oil Paraguay	Citrus aurantium	Leaf
Citrus bergamia	Bergamot essential oil	Citrus bergamia	Fruit peel
Citrus bergamia	Bergamot (FCF) essential oil FCF = Furanocoumarin-free	Citrus bergamia	Fruit peel
Citrus paradisi	Grapefruit essential oil	Citrus paradisi	Fruit peel
Citrus limon	Lemon essential oil	Citrus limon	Fruit peel
Citrus sinensis	Orange essential oil Sweet orange essential oil	Citrus sinensis	Fruit peel
Commiphora myrrha	Myrrh essential oil	Commiphora myrrha	Sap resin
Commiphora myrrha	Myrrh absolute	Commiphora myrrha	Sap resin
Corymbia citriodora	Citron-scent gum essential oil Lemon-scent gum essential oil	Corymbia citriodora	Leaf
Cuminum cyminum	Cumin essential oil	Cuminum cyminum	Seed
Cupressus sempervirens	Italian cypress essential oil Mediterranean cypress essential oil	Cupressus sempervirens	Needle Twig
Cymbopogon citratus	Lemongrass essential oil	Cymbopogon citratus	Leaf
Cymbopogon flexuosus	East Indian lemongrass essential oil Malabar lemongrass essential oil	Cymbopogon flexuosus	Herb top
Cymbopogon martini	Palmarosa essential oil	Cymbopogon martini	Herb top
Cymbopogon nardus	Ceylon citronella essential oil Citronella essential oil	Cymbopogon nardus	Leaf
Cymbopogon winterianus	Burma citronella essential oil Java citronella essential oil	Cymbopogon winterianus	Herb top
Elettaria cardamomum	Cardamom essential oil	Elettaria cardamomum	Seed
Eucalyptus globulus	Eucalyptus essential oil	Eucalyptus globulus	Leaf
Eucalyptus polybractea	Blue mallee essential oil	Eucalyptus polybractea	Leaf
Eucalyptus radiata	Narrow-leaf peppermint essential oil	Eucalyptus radiata	Leaf
Foeniculum vulgare subsp. vulgare var. vulgare	Bitter fennel essential oil	Foeniculum vulgare subsp. vulgare var. vulgare	Seed
Foeniculum vulgare subsp. vulgare var. dulce	Roman fennel essential oil Sweet fennel essential oil	Foeniculum vulgare subsp. vulgare var. dulce	Seed
Helichrysum italicum	Curry plant essential oil Immortelle essential oil	Helichrysum italicum	Herb top flowering
llicium verum	Star anise essential oil	llicium verum	Fruit
Jasminum officinale	Jasmine absolute	Jasminum officinale	Flower
Juniperus communis	Common juniper essential oil Juniper essential oil	Juniperus communis	Fruit
Laurus nobilis	Bay laurel essential oil Laurel essential oil	Laurus nobilis	Leaf Twig
Lavandula angustifolia	Lavender essential oil	Lavandula angustifolia	Herb top flowering
Lavandula x intermedia	Lavandin essential oil	Lavandula x intermedia	Herb top flowering
Lavandula latifolia	Spike lavender essential oil	Lavandula latifolia	Herb top flowering
Litsea cubeba	Litsea essential oil	Litsea cubeba	Fruit
Matricaria chamomilla	Chamomile essential oil German chamomile essential oil	Matricaria chamomilla	Herb top flowering
Melaleuca alternifolia	Tea tree essential oil	Melaleuca alternifolia	Leaf Twig leafy
Melaleuca cajuputi	Cajuput essential oil	Melaleuca cajuputi	Twig leafy
Melaleuca quinquenervia	Niaouli essential oil	Melaleuca quinquenervia	Leaf
Melissa officinalis	Lemon balm essential oil	Melissa officinalis	Leaf
Mentha arvensis	Cornmint essential oil	Mentha arvensis	Leaf Twig flowering
Mentha x piperita	Peppermint essential oil	Mentha x piperita	Herb flowering Leaf Twig flowering
Mentha spicata	Spearmint essential oil	Mentha spicata	Leaf Twig flowering
Myristica fragrans	Nutmeg essential oil	Myristica fragrans	Seed
Myrtus communis	Myrtle essential oil	Myrtus communis	Leaf Twig
Ocimum basilicum³	Sweet basil essential oil	Ocimum basilicum	Herb top flowering
Origanum majorana	Sweet marjoram essential oil Marjoram essential oil	Origanum majorana	Herb top flowering
Pelargonium graveolens	Rose geranium essential oil Geranium essential oil	Pelargonium graveolens	Leaf Herb top flowering
Petroselinum crispum	Parsley essential oil	Petroselinum crispum	Herb top Seed
Pinus sylvestris	Scotch pine essential oil	Pinus sylvestris	Needle
Piper cubeba	Cubeb essential oil	Piper cubeba	Seed
Piper nigrum	Black pepper essential oil	Piper nigrum	Fruit
Pogostemon cablin	Patchouli essential oil	Pogostemon cablin	Leaf
Rosa x damascena	Damask rose essential oil Rose essential oil	Rosa x damascena	Flower
Rosa x centifolia	Provence rose essential oil Rose essential oil	Rosa x centifolia	Flower
Rosmarinus officinalis	Rosemary essential oil	Rosmarinus officinalis	Herb top Twig leafy flowering
Salvia lavandulifolia	Spanish sage essential oil	Salvia lavandulifolia	Herb top flowering
Salvia officinalis	Dalmatian sage essential oil Sage essential oil	Salvia officinalis	Leaf
Salvia sclarea	Clary essential oil Clary sage essential oil	Salvia sclarea	Herb top flowering
Santalum album	East Indian sandalwood essential oil Sandalwood essential oil	Santalum album	Wood
Satureja hortensis	Savory essential oil Summer savory essential oil	Satureja hortensis	Herb top
Styrax benzoin	Benzoin essential oil	Styrax benzoin	Sap resin
Syzygium aromaticum	Clove essential oil	Syzygium aromaticum	Flower bud Leaf Stem
Thymus vulgaris	Thyme essential oil	Thymus vulgaris	Herb top Herb top flowering
Thymus zygis	White thyme essential oil	Thymus zygis	Herb top flowering
Zingiber officinale	Ginger essential oil	Zingiber officinale	Rhizome

¹Brown and yellow camphor essential oils are not permitted due to potential toxicity/carcinogenicity (Tisserand and Young 2014).

²Cinnamomum verum essential oil from bark is not permitted due to potential toxicity/carcinogenicity (Tisserand and Young 2014).

³The estragole chemotype of the sweet basil essential oil is not permitted due to potential toxicity/carcinogenicity (Tisserand and Young 2014).

References: HC 2019, Tisserand and Young 2014, Lis-Balchin 2006, Battaglia 2003, Valnet 2001, Price and Price 1999, Davis 1997.

Route(s) of administration

Topical
Inhalation
Topical and inhalation

Dosage form(s)

Acceptable dosage forms are as follows:

Topical (local application and body massage): Cream; Gel; Liquid; Lotion; Ointment; Solution
Topical (bath and compresses): Liquid (in a dropper bottle)
Inhalation: Liquid (in a dropper bottle)
Topical and Inhalation: Liquid (in a dropper bottle)

Use(s) or Purpose(s)

Consult Table 2 below for uses supported for each medicinal ingredient. The medicinal ingredients in Table 2 are associated with the numbered claims below.

Topical only

Used in aromatherapy for symptomatic relief of acne/boils.
Used in aromatherapy to help relieve minor skin irritation/cuts/bruises/burns.
Used in aromatherapy for symptomatic relief of eczema/dermatitis.
Used in aromatherapy to help relieve joint/muscle pain associated with sprain/strain/rheumatoid arthritis

Topical and/or inhalation

Used in aromatherapy as a nervine/calmative.
Used in aromatherapy to help relieve headache.
Used in aromatherapy as a carminative/antispasmodic for symptomatic relief of digestive discomfort.
Used in aromatherapy to help relieve colds/cough.

Table 2. Aromatherapy essential oils uses or purposes
Medicinal Ingredients	Uses or Purposes
Abies balsamea	4, 5
Abies sibirica	4, 8
Angelica archangelica	4, 5, 6, 7, 8
Aniba rosaeodora	5, 6, 8
Apium graveolens	4, 5
Boswellia frereana (essential oil)	2, 5, 8
Boswellia frereana (absolute)	2, 5, 8
Boswellia sacra (essential oil)	2, 5, 8
Boswellia sacra (absolute)	2, 5, 8
Cananga odorata	5
Carum carvi	7, 8
Cedrus atlantica	1, 2, 4, 5, 8
Chamaemelum nobile	5, 7
Chrysopogon zizanioides	1, 4
Cinnamomum camphora	4, 8
Cinnamomum verum	4, 8
Cistus ladanifer	4, 5, 7
Citrus aurantiifolia	1, 4, 8
Citrus aurantium (Neroli - flower) (essential oil)	5, 6, 7, 8
Citrus aurantium (Neroli - flower) (absolute)	5, 6, 7, 8
Citrus aurantium (Petitgrain - leaf)	4, 5
Citrus bergamia (expressed)	6, 7, 8
Citrus bergamia (expressed - rectified) (FCF)	1, 2, 3, 6, 7, 8
Citrus paradisi	5
Citrus limon	8
Citrus sinensis	5, 7
Commiphora myrrha (essential oil)	2, 3, 8
Commiphora myrrha (absolute)	2, 3, 8
Corymbia citriodora	4, 6, 8
Cuminum cyminum	4, 5, 7
Cupressus sempervirens	4, 8
Cymbopogon citratus	4, 5, 6, 7
Cymbopogon flexuosus	4, 5, 6, 7
Cymbopogon martini	5, 8
Cymbopogon nardus	4, 6, 7
Cymbopogon winterianus	4, 6, 7
Elettaria cardamomum	7, 8
Eucalyptus globulus	4, 6, 8
Eucalyptus polybractea	4, 6, 8
Eucalyptus radiata	4, 6, 8
Foeniculum vulgare subsp. vulgare var. vulgare	2, 4, 7, 8
Foeniculum vulgare subsp. vulgare var. dulce	2, 4, 7, 8
Helichrysum italicum	1, 2, 3, 4, 5, 7, 8
Illicium verum	4, 5, 6, 7, 8
Jasminum officinale	4, 5, 6, 8
Juniperus communis	1, 2, 3, 4, 5
Laurus nobilis	4, 5, 6, 8
Lavandula angustifolia	4, 5, 6, 7, 8
Lavandula x intermedia	4, 5, 6, 7, 8
Lavandula latifolia	4, 5, 6, 7, 8
Litsea cubeba	7
Matricaria chamomilla	1, 2, 4, 5, 6, 7
Melaleuca alternifolia	8
Melaleuca cajuputi	1, 3, 4, 8
Melaleuca quinquenervia	8
Melissa officinalis	5, 7
Mentha arvensis	1, 4, 5, 7, 8
Mentha x piperita	4, 5, 7, 8
Mentha spicata	5, 6, 7, 8
Myristica fragrans	4, 5, 7
Myrtus communis	1, 8
Ocimum basilicum	5, 6, 7, 8
Origanum majorana	2, 3, 4, 5, 6, 7, 8
Pelargonium graveolens	8
Petroselinum crispum	2, 4, 5
Pinus sylvestris	4, 5, 8
Piper cubeba	2, 7, 8
Piper nigrum	4, 6, 7, 8
Pogostemon cablin	1, 2, 5, 7
Rosa x damascena	2, 5, 6, 8
Rosa x centifolia	2, 5, 6, 8
Rosmarinus officinalis	2, 4, 7, 8
Salvia lavandulifolia	2, 4, 5, 7, 8
Salvia officinalis	2, 4, 5, 7, 8
Salvia sclarea	4, 5, 6, 7, 8
Santalum album	5, 6, 7, 8
Satureja hortensis	4, 7, 8
Styrax benzoin	4, 5, 7, 8
Syzygium aromaticum	4, 8
Thymus vulgaris	1, 2, 4, 5, 8
Thymus zygis	1, 2, 4, 5, 8
Zingiber officinale	4, 7, 8

References: HC 2019, Tisserand and Young 2014, Lis-Balchin 2006, Battaglia 2003.

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Refer to Tables 3, 4, 5 and 6 below.

Notes

See Appendix 1 for definitions of various preparations (i.e. steam distilled, expressed, absolute, rectified).
The concentrations in Table 3 below 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 a value between 99 - 100% (Table 4) on the PLA form with appropriate dilution information in the Directions for use section.

Table 3. Topical application - massage or local application: Methods of preparations and concentrations associated with each medicinal ingredient
Medicinal Ingredients	Methods of Preparations	Concentrations for topical application for massage¹	Concentrations for topical local application²	Sensitizing (S) and Phototoxic (P) essential oils³
Abies balsamea	Oil, Essential (water steam distillation)	1 - 5%	1 - 10%	N/A
Abies sibirica	Oil, Essential (water steam distillation)	1 - 2.5%	1 - 2.5%	N/A
Angelica archangelica	Oil, Essential (water steam distillation)	0.78%	0.78%	S, P
Aniba rosaeodora	Oil, Essential (water steam distillation)	1 - 5%	1 - 10%	S
Apium graveolens	Oil, Essential (water steam distillation)	1 - 4%	1 - 4%	S, P
Boswellia frereana	Oil, Essential (water steam distillation)	1 - 5%	1 - 8%	N/A
Boswellia frereana	Absolute	1 - 3%	1 - 3%	N/A
Boswellia sacra	Oil, Essential (water steam distillation)	1 - 5%	1 - 8%	N/A
Boswellia sacra	Absolute	1 - 3%	1 - 3%	N/A
Cananga odorata	Oil, Essential (water steam distillation)	0.8 - 2%	0.8 - 2%	S
Carum carvi	Oil, Essential (water steam distillation)	1 - 4%	1 - 4%	N/A
Cedrus atlantica	Oil, Essential (water steam distillation)	1 - 5%	1 - 8%	P
Chamaemelum nobile	Oil, Essential (water steam distillation)	1 - 4%	1 - 4%	N/A
Chrysopogon zizanioides	Oil, Essential (water steam distillation)	1 - 1.5%	1 - 1.5%	N/A
Cinnamomum camphora	Oil, Essential (water steam distillation)	1 - 5%	1 - 20%	S
Cinnamomum verum	Oil, Essential (water steam distillation)	0.6 - 5%	0.6 - 5%	S
Cistus ladanifer	Oil, Essential (water steam distillation)	1 - 5%	1 - 8%	N/A
Citrus aurantiifolia	Oil, Essential (expressed)	Unripe fruit peel: 0.7%	Unripe fruit peel: 0.7%	P
Citrus aurantiifolia	Oil, Essential (water steam distillation)	Ripe fruit peel: 1 - 5%	Ripe fruit peel: 1 - 15%	N/A
Citrus aurantium (Neroli - flower)	Oil, Essential (water steam distillation)	1 - 4%	1 - 4%	S, P
Citrus aurantium (Neroli - flower)	Absolute	1 - 3%	1 - 3%	S, P
Citrus aurantium (Petitgrain - leaf)	Oil, Essential (water steam distillation)	1 - 5%	1 - 10%	S, P
Citrus bergamia	Oil, Essential (expressed)	0.4%	0.4%	S, P
Citrus bergamia (FCF)	Oil, Essential (expressed - rectified)	1 - 5%	1 - 20%	P
Citrus paradisi	Oil, Essential (expressed)	1 - 4%	1 - 4%	P
Citrus limon	Oil, Essential (expressed)	1 - 2%	1 - 2%	S, P
Citrus limon	Oil, Essential (water steam distillation)	1 - 5%	1 - 10%	N/A
Citrus sinensis	Oil, Essential (expressed)	1 - 5%	1 - 10%	S, P
Commiphora myrrha	Oil, Essential (water steam distillation)	1 - 5%	1 - 8%	N/A
Commiphora myrrha	Absolute	1 - 3%	1 - 3%	N/A
Corymbia citriodora	Oil, Essential (water steam distillation)	1 - 5%	1 - 20%	S
Cuminum cyminum	Oil, Essential (water steam distillation)	0.4%	0.4%	P
Cupressus sempervirens	Oil, Essential (water steam distillation)	1 - 4%	1 - 4%	N/A
Cymbopogon citratus	Oil, Essential (water steam distillation)	0.7 - 4%	0.7 - 4%	S
Cymbopogon flexuosus	Oil, Essential (water steam distillation)	1 - 4%	1 - 4%	S
Cymbopogon martini	Oil, Essential (water steam distillation)	1 - 5%	1 - 6.5%	S
Cymbopogon nardus	Oil, Essential (water steam distillation)	1%	1%	S
Cymbopogon winterianus	Oil, Essential (water steam distillation)	1%	1%	S
Elettaria cardamomum	Oil, Essential (water steam distillation)	1 - 4%	1 - 4%	N/A
Eucalyptus globulus	Oil, Essential (water steam distillation)	1 - 5%	1 - 20%	S
Eucalyptus polybractea	Oil, Essential (water steam distillation)	1 - 5%	1 - 20%	S
Eucalyptus radiata	Oil, Essential (water steam distillation)	1 - 5%	1 - 20%	S
Foeniculum vulgare subsp. vulgare var. vulgare	Oil, Essential (water steam distillation)	1 - 1.8%	1 - 1.8%	N/A
Foeniculum vulgare subsp. vulgare var. dulce	Oil, Essential (water steam distillation)	1 - 2.5%	1 - 2.5%	N/A
Helichrysum italicum	Oil, Essential (water steam distillation)	0.5%	0.5%	N/A
Illicium verum	Oil, Essential (water steam distillation)	1 - 1.75%	1 - 1.75%	S
Jasminum officinale	Absolute	0.7%	0.7%	S
Juniperus communis	Oil, Essential (water steam distillation)	1 - 5%	1 - 8%	N/A
Laurus nobilis	Oil, Essential (water steam distillation)	0.5%	0.5%	S
Lavandula angustifolia	Oil, Essential (water steam distillation)	1 - 5%	1 - 15%	S, P
Lavandula x intermedia	Oil, Essential (water steam distillation)	1 - 5%	1 - 5%	S, P
Lavandula latifolia	Oil, Essential (water steam distillation)	1 - 5%	1 - 8%	S, P
Litsea cubeba	Oil, Essential (water steam distillation)	0.8%	0.8%	S
Matricaria chamomilla	Oil, Essential (water steam distillation)	1 - 4%	1 - 4%	N/A
Melaleuca alternifolia	Oil, Essential (water steam distillation)	1%	1%	S
Melaleuca cajuputi	Oil, Essential (water steam distillation)	1 - 4%	1 - 4%	N/A
Melaleuca quinquenervia	Oil, Essential (water steam distillation)	1 - 5%	1 - 10%	S
Melissa officinalis	Oil, Essential (water steam distillation)	0.7%	0.7%	S
Mentha arvensis	Oil, Essential (water steam distillation)	1 - 5%	1 - 8%	N/A
Mentha x piperita	Oil, Essential (water steam distillation)	1 - 5%	1 - 5.4%	S
Mentha spicata	Oil, Essential (water steam distillation)	1 - 4%	1 - 4%	S
Myristica fragrans	Oil, Essential (water steam distillation)	0.8%	0.8%	N/A
Myrtus communis	Oil, Essential (water steam distillation)	1 - 1.9%	1 - 1.9%	N/A
Ocimum basilicum	Oil, Essential (water steam distillation)	1 - 3.3%	1 - 3.3%	S
Origanum majorana	Oil, Essential (water steam distillation)	1 - 4%	1 - 4%	N/A
Pelargonium graveolens	Oil, Essential (water steam distillation)	1 - 5%	1 - 10%	S
Petroselinum crispum	Oil, Essential (water steam distillation)	Herb top: 1 - 2%	Herb top: 1 - 2%	N/A
Petroselinum crispum	Oil, Essential (water steam distillation)	Seed: 1 - 1.1%	Seed: 1 - 1.1%	N/A
Pinus sylvestris	Oil, Essential (water steam distillation)	1 - 5%	1 - 10%	S
Piper cubeba	Oil, Essential (water steam distillation)	1 - 5%	1 - 8%	N/A
Piper nigrum	Oil, Essential (water steam distillation)	1 - 4%	1 - 4%	N/A
Pogostemon cablin	Oil, Essential (water steam distillation)	1 - 5%	1 - 10%	N/A
Rosa x damascena	Oil, Essential (water steam distillation)	0.6%	0.6%	S
Rosa x centifolia	Oil, Essential (water steam distillation)	1 - 2%	1 - 2%	N/A
Rosmarinus officinalis	Oil, Essential (water steam distillation)	1 - 5%	1 - 6.5%	N/A
Salvia lavandulifolia	Oil, Essential (water steam distillation)	1 - 5%	1 - 12.5%	N/A
Salvia officinalis	Oil, Essential (water steam distillation)	1 - 5%	1 - 8%	N/A
Salvia sclarea	Oil, Essential (water steam distillation)	1 - 5%	1 - 8%	S
Santalum album	Oil, Essential (water steam distillation)	1 - 5%	1 - 10%	S
Satureja hortensis	Oil, Essential (water steam distillation)	0.5 %	0.5 %	N/A
Styrax benzoin	Oil, Essential (water steam distillation)	1 - 2%	1 - 2%	S
Syzygium aromaticum	Oil, Essential (water steam distillation)	Flower bud: 0.5 - 4%	Flower bud: 0.5 - 4%	S
Syzygium aromaticum	Oil, Essential (water steam distillation)	Leaf; Stem: 0.6 - 2%	Leaf; Stem: 0.6 - 2%	S
Thymus vulgaris	Oil, Essential (water steam distillation)	1 - 5%	1 - 8%	N/A
Thymus zygis	Oil, Essential (water steam distillation)	1 - 5%	1 - 8%	N/A
Zingiber officinale	Oil, Essential (water steam distillation)	1 - 4%	1 - 4%	N/A

¹This section refers to minimum and maximum concentrations after dilution for body massage (covering more than 10% of body surface area).

²This section refers to minimum and maximum concentrations after dilution for local applications (covering up to 10% of body surface area).

³(S) - Sensitizing: For definition, see Appendix 1. Additional duration of use and risk statements are required for medicinal ingredients indicated as sensitizing. Refer to Risk information section. Sensitizing ingredients cannot be included in products intended for use on irritated, broken or sensitive skin. (P) - Phototoxic: For definition, see Appendix 1. Additional risk statements are required for medicinal ingredients indicated as phototoxic. Refer to Risk information section.

References: HC 2019, Tisserand and Young 2014, Lis-Balchin 2006, Battaglia 2003.

Table 4. Topical application - massage or local application: Methods of preparations and concentrations for undiluted products¹
Medicinal Ingredients	Methods of Preparations	Concentration for single ingredient products or total concentration of ingredients from Table 1 for multi-ingredient products
Any ingredient listed in Table 1²	Absolute Oil, Essential (water steam distillation) Oil, Essential (expressed) Oil, Essential (expressed- rectified)	99 - 100%³

¹The quantity per dosage unit for undiluted (pure) essential oils should be indicated as a value between 99 - 100% on the PLA form with appropriate dilution information (such as mixing XX drops of the product in YY mL of carrier oil) in the Directions for use section to meet the concentrations listed in Table 3 once diluted.

²Sensitizing ingredients cannot be included in products intended for use on irritated, broken or sensitive skin.

³A minimum concentration of 99% has been included to allow for the addition of a non-medicinal ingredient with a preservative antioxidant purpose as needed.

Table 5. Topical application - bath or compresses: Methods of preparations and concentration for all medicinal ingredients listed in Table 1
Medicinal Ingredients	Methods of Preparations	Concentration for single ingredient products or total concentration of ingredients from Table 1 for multi-ingredient products
Any ingredient listed in Table 1¹	Absolute Oil, Essential (water steam distillation) Oil, Essential (expressed) Oil, Essential (expressed- rectified)	99 - 100%²

¹Sensitizing ingredients cannot be included in products intended for use on irritated, broken or sensitive skin.

²If a combination of essential oils is used, the total concentration of essential oils must be a value between 99 - 100% and each essential oil included in the combination must contribute to the recommended uses for the product. A minimum concentration of 99% has been included to allow for the addition of a non-medicinal ingredient with a preservative antioxidant purpose as needed.

Table 6. Inhalation - tissue or steaming water: Methods of preparations and concentration for all medicinal ingredients listed in Table 1
Medicinal Ingredients	Methods of Preparations	Concentration for single ingredient products or total concentration of ingredients from Table 1 for multi-ingredient products
Any ingredient listed in Table 1	Absolute Oil, Essential (water steam distillation) Oil, Essential (expressed) Oil, Essential (expressed- rectified)	99 - 100%¹

¹If a combination of essential oils is used, the total concentration of essential oils must be a value between 99 - 100% and each essential oil included in the combination must contribute to the recommended uses for the product. A minimum concentration of 99% has been included to allow for the addition of a non-medicinal ingredient with a preservative antioxidant purpose as needed.

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 Table 3.

Direction(s) for use

All products

Not for oral use.
Avoid contact with eyes and mucous membranes; if this happens, rinse thoroughly with vegetable oil.

Topical

Local application (10% or less of body surface area)

Apply to a small body area only, 1 to 3 times per day. Rub and/or massage into skin until solution vanishes.

Body massage (more than 10% of the body surface area)

Apply as a body massage once daily. Rub and/or massage into skin until solution vanishes.

Products requiring dilution (topical)

Do not use the product undiluted.
Mix XX drops of the product in YY ml of carrier oil prior to applying on the skin¹.

¹Notes

Single ingredient products

Directions for use explaining appropriate dilution of the product in carrier oil must be included on the PLA form and label. The final concentration to be applied on the skin must meet the concentrations in Table 3.

The following information is required on the PLA form to calculate the final concentration of the product:

The number of drops of the product (XX) to be diluted in the carrier oil.
The volume of the drop (ml) (e.g. 0.05 ml).
The volume of the carrier oil (YY) (i.e. fixed oil used to dilute essential oils and absolutes) (ml). Please note that the consumer must be able to measure this volume accurately in the absence of a measuring device (e.g. 5 ml = 1 teaspoon).

Formula to obtain the final concentration of the product:

Final concentration of the product (%) = [# of drops of the product * Volume of the drop (ml) * 100] / Final Volume (ml)

Note:

Final volume (ml) = [# of drops of the product * Volume of the drop (ml)] + Volume of carrier oil (ml)

Combination products

The following information is required on the PLA form for each medicinal ingredient to calculate the final concentration of each medicinal ingredient and of the finished product:

The number of drops of the product (XX) to be diluted in the carrier oil.
The volume of each medicinal ingredient per drop (ml).
The volume of the carrier oil (YY) (i.e. fixed oil used to dilute essential oils and absolutes) (ml) (the same value for each medicinal ingredient). Please note that the consumer must be able to measure this volume accurately in the absence of a measuring device (e.g. 5 ml).

Formula to obtain the final concentration of each medicinal ingredient (MI):

Final concentration of the MI (%) = [# of drops of the product * Volume of the MI per drop (ml) * 100] / Final Volume (ml)

Note:

Final volume (ml) = [# of drops of the product * Volume of the drop (ml)] + Volume of carrier oil (ml)

Formula to obtain the final concentration of the finished product (maximum concentration of combined medicinal ingredient is 5%):

Final concentration of the product (%) = [# of drops of the product * Volume of all MI per the drop (ml) * 100] / Final Volume (ml)

Notes:

The volume of all medicinal ingredients (MI) per drop (ml) in the formula below = sum of the volumes of each medicinal ingredient per drop (ml).
Final volume (ml) = [# of drops of the product * Volume of the drop (ml)] + Volume of carrier oil (ml).

Bath

Add 2 - 8 drops of undiluted product 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 product the first time and increase by 1 drop per bath up to a maximum of 8 drops. Use once daily (Tisserand 1977; Price and Price 2007).

Compresses

Add 2 drops of undiluted product 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. Use 1 to 3 times per day (Tisserand 1977).

Inhalation

Handkerchief/tissue

Apply 1 - 6 drops of undiluted product to a handkerchief/tissue and inhale occasionally. Use 1 to 3 times per day (Price and Price 2007).

Steaming water/facial steamer

Add 3 - 12 drops of undiluted product to a bowl of steaming water/facial steamer. Inhale slowly and deeply for 5 to 10 minutes. Use 1 to 3 times per day (Price and Price 1999; Tisserand and Balacs 1995).

Duration(s) of use

All products

For occasional use only.

Risk information

All products

Caution(s) and warning(s)

Keep out of reach of children.
Seek urgent medical attention or contact a Poison Control Center if accidental ingestion occurs.
Consult a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.
Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you have epilepsy or asthma (Tisserand and Young 2014).

Contraindication(s)

Do not use this product if you are pregnant or breastfeeding.

Known adverse reaction(s)

Stop use if you experience nausea, dizziness, headache, an allergic reaction or skin irritation (Tisserand and Young 2014).

Products for topical application (local application/body massage/bath/compresses)

Caution(s) and warning(s)

All products (except products that contain phototoxic essential oils; refer to Table 3)

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

Products that contain phototoxic essential oils (refer to Table 3)

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 Table 3)

Do not use this product on broken, irritated, or sensitive skin.

Products that contain Cananga odorata essential oil >0.8% and/or Cinnamomun verum essential oil >0.6% and/or Cymbopogon citratus essential oil >0.7% and/or Mentha spicata >1.7% and/or Syzygium aromaticum flower bud essential oil >0.5% and/or Syzygium aromaticum leaf or stem essential oil >0.6%

Do not use this product if you are prone to allergic reactions, eczema or unusual skin reactions.

Products intended to help relieve colds/cough

Known adverse reaction(s)

Stop use and consult a health care practitioner/health care provider/health care professional/doctor/physician if symptoms are accompanied by a fever, rash, persistent headache or chronic lung condition.

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.
The addition of a non-medicinal ingredient with a preservative antioxidant purpose to the product formulation is recommended.
Products supported by this monograph cannot include any essential oils as non-medicinal ingredients.

Storage conditions

All products

Child-resistant packaging/containers should be used (JC 2012).
Store in airtight, light-resistant container at room temperature or in a refrigerator (Tisserand and Young 2014).

Specifications

The finished product specifications must be established in accordance with the requirements described in the Natural and Non-Prescription Health Products Directorate (NNHPD) Quality of Natural Health Products Guide
The medicinal ingredient must comply with the requirements outlined in the NHPID.
Essential oils rich in linalool or limonene should only be used when the level of peroxides is kept to the lowest practical value. The addition of antioxidants at the time of production is recommended for these essential oils (Tisserand and Young 2014; IFRA 2004).

References cited

AHPA 2012: American Herbal Products Association Guidance Policies: Trade Requirement & Guidance Policy for Labeling of Undiluted Essential Oils Used Topically and Offered for Retail Sale, [Accessed 2014 July 14]. Available from: http://www.ahpa.org/Default.aspx?tabid=223#section_essentialoils

Battaglia, S. The Complete Guide to Aromatherapy, 2nd ed. Brisbane (AU): The International Centre of Holistic Aromatherapy; 2003.

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

HC 2019: Health Canada, Natural Health Product Ingredients Database: Counterirritants. [Published 2019 April 29]. Available from: http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=counter&lang=eng

IFRA 2004: IFRA Standards, including amendments. International Fragrance Association, Brussels. http://www.ifraorg.org

JC 2012: Justice Canada. Cautionary 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]. Available from: http://laws- lois.justice.gc.ca/eng/regulations/C.R.C.%2C_c._870/page- 205.html?texthighlight=statements+cautionary+resistant+packages+child

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.

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. Germplasm Resources Information Network - (GRIN) [Internet]. National Germplasm Resources Laboratory, Beltsville, Maryland. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl

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

Appendix 1

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:

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).

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Date modified:: 2019-03-01