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Drugs and Health Products

Aromatherapy — Essential Oils

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

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

April 8, 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
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

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

Topical and/or inhalation

  1. Used in aromatherapy as a nervine/calmative.
  2. Used in aromatherapy to help relieve headache.
  3. Used in aromatherapy as a carminative/antispasmodic for symptomatic relief of digestive discomfort.
  4. 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)

1 - 2%

1 - 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)

1 - 5%

1 - 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

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

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)

1 - 4%

1 - 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)

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

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: 1 - 4%

Flower bud: 1 - 4%

S

Leaf; Stem: 1 - 2%

Leaf; Stem: 1 - 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

All topical products

Rub and/or massage into skin until solution vanishes.


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

Apply to a small body area only, 1 to 3 times per day.


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

Apply as a body massage once daily.


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

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 for each medicinal ingredient and not exceed a total concentration of 5%.

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.do?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).