In this guide

Discussion paper on the potential health effects of Echinacea in the maternal diet

TOX/2024/43 Annex B

TOX/2024/43

Last updated: 03 December 2024

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In this guide

Table 8a: Combined acute consumption scenarios for 4-5 products of Echinacea (as dried root/herb) during pregnancy.

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Tea

Honey

Lozenges

Tablets/capsules

Oral liquids

Total consumed per day

860 - 6,000

19 - 100

40

400 - 3,600

600 - 3,000

1,900 - 13,000

N/A

19 - 100

40

400 - 3,600

600 - 3,000

1,100 - 6,700

860 - 6,000

N/A

40

400 - 3,600

600 - 3,000

1,900 -13,000

860 - 6,000

19 - 100

N/A

400 - 3,600

600 - 3,000

1,900 - 13,000

860 - 6,000

19 - 100

40

N/A

600 - 3,000

1,500 - 9,100

860 - 6,000

19 - 100

40

400 - 3,600

N/A

1,300 - 9,700

*Rounded to 2 significant figures.

Table 8b: Combined acute consumption scenarios for 3 products of Echinacea (as dried root/herb) during pregnancy.

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Tea

Honey

Lozenges

Tablets/capsules

Oral liquids

Total consumed per day

860 - 6,000

19 - 100

40

N/A

N/A

920 - 6,100

860 - 6,000

19 - 100

N/A

400 - 3,600

N/A

1,300 - 9,700

860 - 6,000

19 - 100

N/A

N/A

600 - 3,000

1,500 - 9,100

860 - 6,000

N/A

N/A

400 - 3,600

600 - 3,000

1,900 - 13,000

860 - 6,000

N/A

40

400 - 3,600

N/A

1,300 - 9,600

860 - 6,000

N/A

40

N/A

600 - 3,000

1,500 - 9,000

N/A

N/A

40

400 - 3,600

600 - 3,000

1,000 - 6,700

N/A

19 - 100

N/A

400 - 3,600

600 - 3,000

1,000 - 6,700

N/A

19 - 100

40

400 - 3,600

N/A

460 - 3,700

N/A

19 - 100

40

N/A

600 - 3,000

660 - 3,100

*Rounded to 2 significant figures.

Table 8c: Combined acute consumption scenarios for 2 products of Echinacea (as dried root/herb) during pregnancy.

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Tea

Honey

Lozenges

Tablets/capsules

Oral liquids

Total consumed per day

860 - 6,000

19 - 100

N/A

N/A

N/A

900 - 6,100

860 - 6,000

N/A

40

N/A

N/A

900 - 6,000

860 - 6,000

N/A

N/A

400 - 3,600

N/A

1,300 - 9,600

860 - 6,000

N/A

N/A

N/A

600 - 3,000

1,500 - 9,600

N/A

19 - 100

40

N/A

N/A

60 - 140

N/A

19 - 100

N/A

400 – 3,600

N/A

420 - 3,700

N/A

19 - 100

N/A

N/A

600 - 3,000

620 - 3,100

N/A

N/A

40

400 - 3,600

N/A

440 - 3,600

N/A

N/A

40

N/A

600 - 3,000

640 - 3,000

N/A

N/A

N/A

400 - 3,600

600 - 3,000

1,000 - 6,600

*Rounded to 2 significant figures.

Table 9a: Combined chronic consumption scenarios for 4-5 products of Echinacea (as dried root/herb) during pregnancy.

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Tea

Honey

Lozenges

Tablets/capsules

Oral liquids

Total consumed per day

580 – 4,000

10-53

40

400 - 3,600

600 - 3,000

1,600 - 11,000

N/A

10-53

40

400 - 3,600

600 - 3,000

1,100 – 6,700

580 – 4,000

N/A

40

400 - 3,600

600 - 3,000

1,600 – 11,000

580 – 4,000

10-53

N/A

400 - 3,600

600 - 3,000

1,600 – 11,000

580 – 4,000

10-53

40

N/A

600 - 3,000

1,200 – 7,100

580 – 4,000

10-53

40

400 - 3,600

N/A

1,000 – 7,700

*Rounded to 2 significant figures.

Table 9b: Combined chronic consumption scenarios for 3 products of Echinacea (as dried root/herb) during pregnancy.

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Tea

Honey

Lozenges

Tablets/capsules

Oral liquids

Total consumed per day

580 – 4,000

10-53

40

N/A

N/A

600 - 4,100

580 – 4,000

10-53

N/A

400 - 3,600

N/A

1,000 – 7,700

580 – 4,000

10-53

N/A

N/A

600 - 3,000

1,200 – 7,100

580 – 4,000

N/A

N/A

400 - 3,600

600 - 3,000

1,600 –11,000

580 – 4,000

N/A

40

400 - 3,600

N/A

1,000 – 7,600

580 – 4,000

N/A

40

N/A

600 - 3,000

1,200 – 7,000

N/A

N/A

40

400 - 3,600

600 - 3,000

1,000 – 6,600

N/A

10 - 53

N/A

400 - 3,600

600 - 3,000

1,000 - 6,700

N/A

10 - 53

40

400 - 3,600

N/A

450-3,700

N/A

10 - 53

40

N/A

600 - 3,000

650-3,100

*Rounded to 2 significant figures.

Table 9c: Combined chronic consumption scenarios for 2 products of Echinacea (as dried root/herb) during pregnancy.

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Estimated consumption of Echinacea (mg/day)

Tea

Honey

Lozenges

Tablets/capsules

Oral liquids

Total consumed per day

580 – 4,000

10-53

N/A

N/A

N/A

600 - 4,100

580 – 4,000

N/A

40

N/A

N/A

620 - 4,000

580 – 4,000

N/A

N/A

400 - 3,600

N/A

1,000 - 7,600

580 – 4,000

N/A

N/A

N/A

600 - 3,000

1,200 - 7,000

N/A

10-53

40

N/A

N/A

50 - 93

N/A

10-53

N/A

400 – 3,600

N/A

410 - 3,700

N/A

10-53

N/A

N/A

600 - 3,000

610 - 3,100

N/A

N/A

40

400 - 3,600

N/A

440 - 3,600

N/A

N/A

40

N/A

600 - 3,000

640 - 3,000

N/A

N/A

N/A

400 - 3,600

600 - 3,000

1,000 - 6,600

*Rounded to 2 significant figures.

Table 10: Echinacea products (oral dosage forms) with THR in the UK.

Product name

Dosage form

Echinacea species and plant part

Composition

Directions for use

Daily dose Echinacea (mg)

Echinaflu Soft Capsules.

Capsules.

Echinacea purpurea (L.) Moench herb.

176 mg of dried pressed juice from fresh flowering herb equivalent to 3.5-4.9 g of fresh herb (DER 20-28:1).

1-2 capsules daily for no longer than 10 days.

176 - 352 mg dried pressed juice equivalent to 3.5 - 9.8 g fresh herb.

Echinacea Cold and Flu Capsules.

Capsules.

Echinacea purpurea (L.) Moench) root.

140 mg dry extract from root equivalent to 838 - 1117 mg root (DER 6-8:1).

1 capsule twice a day.

280 mg dry root extract equivalent to 1,676- 2,234 mg root.

Ekinalife.

Capsules.

Echinacea pallida (Nutt.) Nutt. root and Echinacea purpurea (L.) Moench root.

200mg of Echinacea pallida. Nutt. and 200mg of Echinacea purpurea (L.) Moench powedered root.

1 capsule twice a day for no longer than 10 days.

400 mg E. pallida powdered root and 400 mg E. purpurea powdered root.
Total of 1,600 mg powdered root.

Solgar Echinacea Cold and Flu Capsules.

Capsules.

Echinacea purpurea (L.) Moench root.

140 mg dry extract from root equivalent to 838 - 1117 mg root (DER 6-8:1).

1 capsule twice a day for no longer than 10 days.

280 mg dry root extract equivalent to 1,676- 2,234 mg root.

Phytocold.

Capsules.

Echinacea purpurea (L.) Moench root.

250 mg powdered root.

1-2 capsules three times a day fo no longer than 10 days.

750 - 1,500 mg powdered root.

Echinaflu Effervescent Tablets.

Effervescent Tablets.

Echinacea purpurea (L.) Moench herb.

176 mg of dried pressed juice from fresh flowering herb equivalent to 3.5-4.9 g of fresh herb (DER 20-28:1).

1-2 tablets daily for no longer than 10 days.

176 - 352 mg dried pressed juice equivalent to 3.5 - 9.8 g fresh herb.

Echineeze.

Tablets.

Echinacea purpurea (L.) Moench root.

70 mg dry extract from root equivalent to 460 – 530 mg root (DER 6.5-7.5:1).

1 tablet 3 times a day for no longer than 10 days.

210 mg dry root extract equivalent to 1,380 - 1,590 mg root.

Echinaforce Forte Cold & Flu Tablets.

Tablets.

Echinacea purpurea (L.) Moench herb and root.

1,140 mg dry extract from fresh herb (DER 1:12) and 60 mg (DER 1:11) dry extract from fresh root.

1 tablet two to three times a day for no longer than 10 days.

2,280 - 3,420 mg dry herb extract and 120-180 mg dry root extract.

Herbal Cold And Flu Relief Tablets.

Tablets.

Echinacea purpurea (L.) Moench root.

71.5 mg dry extract from root equivalent to 429 - 500 mg root (DER 6-7:1).

1-2 tablets twice daily for no longer than 10 days.

143-286 mg dry root extract equivalent to 858 - 2,000 mg root.

High Strength Herbal Cold And Flu Relief Tablets.

Tablets.

Echinacea purpurea (L.) Moench root.

143 mg dry extract from root equivalent to 858 - 1000 mg root (DER 6-7:1).

1 tablet three times a day for no longer than 10 days.

429 mg dry root extract equivalent to 2,574 - 3,000 mg root.

Echinacea Skin Care Tablets.

Tablets.

Echinacea purpurea (L.) Moench root.

71.5 mg dry extract from root equivalent to 429 - 500 mg root (DER 6-7:1).

1-2 tablets three times a day for no longer than 10 days.

143-286 mg dry root extract equivalent to 858 - 2,000 mg root.

Herbal Classics Echinacea Cold Relief Film-Coated Tablets.           

Tablets.

Echinacea purpurea (L.) Moench root.

40 mg dry extract from root equivalent to 260 mg root (DER 6.5:1).

2-3 tablets three times a day.

240-360 mg dry root extract equivalent to 1,560 -2,340 mg root.

HRI Cold And Flu Echinacea Tablets.

Tablets.

Echinacea purpurea (L.) Moench root.

56 mg dry extract from root equivalent to 338 - 450 mg root (DER 6-8:1).

1-2 tablets twice daily.

112-224 mg dry root extract equivalent to 676-1,800 mg root.

Echinapret Coated Tablets.

Tablets.

Echinacea purpurea (L.) Moench herb.

175 mg of dried pressed juice from fresh flowering herb equivalent to 6.7 - 9.8 g fresh herb (DER 38 - 56:1).

1 tablet three times a day for no longer than 10 days.

525 mg dried pressed juice equivalent to 18.4 - 29.4 mg fresh herb.

Thompson and Capper Echinacea Cold-n-Flu-Eze.

Tablets.

Echinacea purpurea (L.) Moench root.

105 mg dry extract from root equivalent to 630 - 840 mg root (DER 6-8:1).

1 tablet twice a day for no longer than 10 days.

210 mg dry root extract equivalent to 1,260 -1,680 mg root.

Fuerte Tablets.

Tablets.

Wild indigo root (Baptisia tinctoria (L.) R.Br.), Echinacea purpurea root (Echinacea purpurea (L.) Moench), Echinacea pallida root (Echinacea pallida (Nutt.) Nutt.), White cedar tips and leaves (Thuja occidentalis L.).

3.2 mg dry root extract (DER 4-9:1) from Wild indigo root, E. purpurea root, E. pallida root and Wild cedar tips and leaves

(4.92:1.85:1.85:1).

5 tablets three times a day for no longer than 10 days.

9.2 mg E. pallida and 9.2 mg E. purpurea dry root extract. Total 18.4 mg dry root extract equivalent to 73.6-165.6 mg root.

Healthsense Echinashield Cold and Flu Tablets.

Tablets.

Echinacea purpurea (L.) Moench root.

70 mg dry extract from root equivalent to 420 - 560 mg root (DER 6-8:1).

1 tablet three times a day for no longer than 10 days.

210 mg dry root extract equivalent to 1,260 -1,680 mg root.

Lamberts Echinacea Cold &  Flu relief tablets Nature’s Best Echinacea Cold & Flu Relief tablets.

Tablets.

Echinacea purpurea (L.) Moench root.

105 mg dry extract from root equivalent to 630 - 840 mg root (DER 6-8:1).

1 tablet twice a day for no longer than 10 days.

210 mg dry root extract equivalent to 1,260 -1,680 mg root.

Vitabiotics Echinacea Tablets.

Tablets.

Echinacea purpurea (L.) Moench root.

200 mg dry extract from root equivalent to 1200 - 1600 mg root (DER 6-8:1).

1 tablet twice a day for no longer than 10 days.

400 mg dry root extract equivalent to 2,400 -3,200 mg root.

Potter’s Skin Clear Tablets.

Tablets.

Echinacea angustifolia (D.C) root.

110 mg dry extract from root equivalent to 500 mg root (DER 4.5:1).

2 tablets three times a day for no longer than 10 days.

660 mg dry root extract equivalent to 2,970 mg root.

EKINACLEAR.

Tablets.

Echinacea purpurea (L.) Moench root.

50 mg dry extract from root equivalent to 300 - 400 mg root (DER 6-8:1).

1-2 tablets three times a day for no longer than 10 days.

150-300 mg dry root extract equivalent to 900-2,400 mg root.

Lifeplan Echinacea Cold and Flu Relief Tablets.

Tablets.

Echinacea purpurea (L.) Moench root.

140 mg dry extract from root equivalent to 840 - 1120 mg root (DER 6-8:1).

1 tablet twice a day for no longer than 10 days.

150-300 mg dry root extract equivalent to 900-2,400 mg root.

Echinaforce Chewable Cold & Flu Tablets.

Chewable tablets.

Echinacea purpurea (L.) Moench herb and root.

380 mg dry extract from fresh herb (DER 1:12) and 20 mg dry extract (DER 1:11) from fresh root.

2 tablets two to three times a day for no longer than 10 days.

1,520 - 2,280 mg dry herb extract and 80-120 mg dry root extract.

Herbal Cold And Flu Sachets.

Sachets.

Echinacea purpurea (L.) Moench root.

71.5 mg dry extract from root equivalent to 429 - 500 mg root (DER 6-7:1).

1 sachet three times a day for no longer than 10 days.

214.5 mg dry root extract equivalent to 1,287-1,500 mg root.

Cystorelief Cystitis Uva-ursi & Echinacea oral dropsa.

Tincture.

 Echinacea purpurea (L.) Moench herb, Uva-ursi herb (Arctostaphylos uva-ursi (l.) Spreng, Herb).

240 mg of tincture from fresh herb (DER 1:12) per 1 ml.

15 drops in a little water 2-5 times daily. 1mL is equivalent to 30 drops.

240-600 mg of tincture from fresh herb.

Potter’s Elixir of Echinacea Plus/Napiers Elixir of Echinacea Complexb.

Oral solution.

Echinacea angustifolia (D.C) root, Wild Indigo root, Fumitory herb.

0.64 mL liquid extract from root equivalent to 640 mg root per 5 mL (DER 1:1).

5 mL three times a day for no longer than 10 days.

 1.92 mL liquid root extract equivalent to 1.92 g root.

Echinacin Juice MADAUS.

Oral solution.

Echinacea purpurea (L.) Moench) herb.

117 mg of dried pressed juice from fresh flowering herb equivalent to 3.7 - 6.3 g of fresh herb per 5 mL (DER 31.5-53.6:1).

5 mL three times a day for no longer than 10 days.

351 mg dried pressed juice equivalent to 11.1 - 18.9 g fresh herb.

Echinacin Liquidum MADAUSc.

Oral solution.

Echinacea purpurea (L.) Moench) herb.

1.99 g of pressed juice from fresh flowering herb equivalent to 3.4 - 5 g of fresh herb per 2.5 mL (DER 1.7-2.5:1).

2.5 mL three times a day for no longer than 10 days.

5,970 mg pressed juice equivalent to 10.2-15 g fresh herb.

Echinaforce hot drink cold & flu echinacea concentrate for oral solution.

Tincture.

Echinacea purpurea (L.) Moench herb and root.

1,140 mg extract (as tincture) from fresh herb (DER 1:12-13) and 60 mg extract (as tincture) from fresh root (DER 1:11-12) per 5 ml.

Days 1-3: Take 5 ml diluted in hot water five times daily.
Days 4-10: Take 5 ml diluted in hot water three times daily.

3,420 - 5,700 mg herb extract (tincture) and 180-300 mg root extract (tincture).

Echinaforce Sore Throat Sprayd.

Oromucosal spray.

Echinacea purpurea (L.) Moench herb and root, Sage leaves, (Salvia officinalis L. folium).

863.3 mg tincture from fresh herb (DER 1:12) and 45.5 mg tincture from fresh root (DER 1:11) per 1 mL.

1 spray (0.22 mL) six to ten times a day for no more than 7 days.

1,147 - 1,910 mg herb tincture and 60 - 100 mg root tincture.

Duchy Herbals Echina-Relief Tincturee.

Tincture.

Echinacea purpurea (L.) Moench root.

1mL of tincture from dried root (1:3) (equivalent to 33 mg dried root) per 1 mL tincture.

2.5 ml of tincture, in water, two or three times daily for no longer than 10 days.

5-7.5 mL tincture equivalent to 165 - 248 mg dried root.

a 1 mL contains 426 mg ethanol equivalent to 10.8 mL beer or 4.5 mL wine (43% v/v ethanol content).

b 5 mL contains 760 mg ethanol equivalent to 19 mL beer or 7.9 mL wine (19 % v/v ethanol content).

c 1 mL contains 179 mg ethanol equivalent to 4 mL beer or 1.6 mL wine (18% v/v ethanol content).

d 1 mL contains 370 mg ethanol equivalent to 8.4 mL beer or 3.4 mL wine (38-42% v/v ethanol content).

e 2.5 mL contains 900 mg ethanol equivalent to 23 mL beer or 10 mL wine (38-45% v/v ethanol content).

 Table 11: Summary of doses and preparations of THR products in the UK and EMA monographs.

Echinacea species

Daily dose THR products UK

EMA monographs daily doses

Echinacea purpurea.

Pressed juice from herb (DER 1.7-2.5:1):
5,970 mg (equivalent to 10.2-15 g fresh herb).

Dried pressed juice from herb (DER 20-28:1):
176-352 mg (equivalent to 3.5 - 9.8 g fresh herb)

Dry root extract (DER 6-7:1):
143 - 429 mg (equivalent to 858 - 3,000 mg root)
Powdered root:
250 -1500 mg.

Pressed juice from herb (DER 1.5-2.5:1):

6 - 9 g (equivalent to 9 - 22.5 g fresh herb.).

Dried pressed juice:

Corresponding to the expressed juice above.

(EMA monograph, 2014).

Dry root extract (DER 5.5-7.5:1):

360 mg (equivalent to 1,980 - 2,700 mg root).

(EMA monograph, 2017).

Echinacea angustifolia.

Dry root extract (DER 4.5:1):
660 mg equivalent to 2,970 mg root.
Liquid root extract (DER 1:1):
1.92 mL (equivalent to 1,920 mg root).

Powdered root:
500-1,500 mg.

Liquid root extract (DER 1:1):
0.75 - 3 mL (equivalent to 750 -3,000 mg root).

Tincture (DER 5:1):
3-6 mL (equivalent to 1,500 - 3,000 mg root).

(EMA monograph 2018).

Echinacea pallida.

Dry root extract (DER 4-9:1):
9.2 mg E. pallida and 9.2 mg E. purpurea (equivalent to 36.8-82.8 mg root).

Powdered root:
400 mg E. pallida and 400 mg E. purpurea.

Dry root extract (DER 4-8:1):
90-96 mg (equivalent to 360 - 786 mg root).

(EMA monograph 2012).
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