
Article 1 
Annexes I and II to Decision 2008/911/EC are amended in accordance with the Annex to this Decision.
Article 2 
This Decision is addressed to the Member States.
Done at Brussels, 24 January 2018.
For the Commission
Vytenis ANDRIUKAITIS
Member of the Commission
ANNEX

Decision 2008/911/EC is amended as follows:

((1)) in Annex I, the following substance is inserted after Thymus vulgaris L., Thymus zygis Loefl. ex L., aetheroleum:
'Valeriana officinalis L.';
((2)) in Annex II, the following is inserted after the COMMUNITY LIST ENTRY on Thymus vulgaris L., Thymus zygis Loefl. ex L., aetheroleum:
'

Scientific name of the plant
Valeriana officinalis L.
Botanical family
Valerianaceae
Common name in all EU official languages of herbal preparation
BG (bălgarski): Валериана, коренCS (čeština): kozlíkový kořenDA (dansk): BaldrianrodDE (Deutsch): BaldrianwurzelEL (elliniká): Ρίζα βαλεριανήςEN (English): Valerian rootES (español): Valeriana, raíz deET (eesti keel): palderjanijuurFI (suomi): rohtovirmajuuri, juuriFR (français): Valériane (racine de)HR (hrvatska): odoljenov korijenHU (magyar): MacskagyökérIT (italiano): Valeriana radice LT (lietuvių kalba): Valerijonų šaknysLV (latviešu valoda): Baldriāna saknesMT (Malti): Għerq tal-ValerjanaNL (Nederlands): ValeriaanwortelPL (polski): Korzeń kozłkaPT (português): Valeriana, raizRO (română): rădăcină de valerianăSK (slovenčina): Koreň valeriánySL (slovenščina): korenina zdravilne špajkeSV (svenska): Vänderot, rotIS (íslenska):NO (norsk): Valerianarot
Herbal preparation(s)

((a)) Comminuted herbal substance
((b)) Powdered herbal substance
((c)) Expressed juice from fresh root (1:0,60-0,85)
((d)) Dry extract (DER 4-6:1), extraction solvent: water
((e)) Liquid extract (DER 1:4-6), extraction solvent: water
((f)) Dry extract (DER 4-7:1), extraction solvent: methanol 45 % (V/V)
((g)) Dry extract (DER 5,3-6,6:1), extraction solvent: methanol 45 % (m/m)
((h)) Liquid extract (DER 1:7-9), extraction solvent: sweet wine
((i)) Liquid extract (DER 1:1), extraction solvent: ethanol 60 % (V/V)
((j)) Tincture (ratio of herbal substance to extraction solvent 1:8), extraction solvent: ethanol 60 % (V/V)
((k)) Tincture (ratio of herbal substance to extraction solvent 1:10), extraction solvent: ethanol 56 %
((l)) Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent: ethanol 70 % (V/V)
((m)) Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent: ethanol 60-80 % (V/V)
((n)) Dry extract (DER 5,5-7,4:1), extraction solvent: ethanol 85 % (m/m)
European Pharmacopoeia monograph reference
04:2017:0453
Indications
Traditional herbal medicinal product for relief of mild symptoms of mental stress and to aid sleep.The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use.
Type of tradition
European.
Specified strength
Please see ‘Specified posology’.
Specified posology

Oral use


((a)) single dose: 0,3-3 g
For relief of mild symptoms of mental stress up to 3 times daily.
To aid sleep, a single dose half to one hour before bedtime with an earlier dose during the evening if necessary.
Herbal tea: 0,3-3 g of the comminuted herbal substance in 150 ml of boiling water as a herbal infusion
((b)) single dose: 0,3-2,0 g
For relief of mild symptoms of mental stress up to 3 times daily.
To aid sleep, a single dose half to one hour before bedtime with an earlier dose during the evening if necessary.
((c)) single dose: 10 ml
For relief of mild symptoms of mental stress up to 3 times daily.
To aid sleep, a single dose half to one hour before bedtime with an earlier dose during the evening if necessary.
((d)) single dose: 420 mg
For relief of mild symptoms of mental stress up to 3 times daily.
To aid sleep, a single dose half to one hour before bedtime with an earlier dose during the evening if necessary.
((e)) single dose: 20 ml
For relief of mild symptoms of mental stress up to 3 times daily.
To aid sleep, a single dose half to one hour before bedtime.
((f)) single dose: 144-288 mg
For relief of mild symptoms of mental stress up to 4 times daily.
To aid sleep, a single dose half to one hour before bedtime with an earlier dose during the evening if necessary.
((g)) single dose: 450 mg
For relief of mild symptoms of mental stress up to 3 times daily.
To aid sleep, a single dose half to one hour before bedtime with an earlier dose during the evening if necessary.
((h)) single dose: 10 ml, up to 3 times daily
((i)) single dose: 0,3-1,0 ml, up to 3 times daily
((j)) single dose: 4-8 ml, up to 3 times daily
((k)) single dose: 0,84 ml
For relief of mild symptoms of mental stress 3-5 times daily.
To aid sleep, a single dose half an hour before bedtime.
((l)) single dose: 1,5 ml (mental stress), 3 ml (to aid sleep)
For relief of mild symptoms of mental stress up to 3 times daily.
To aid sleep, a single dose half an hour before bedtime.
((m)) single dose: 10 ml, up to 3 times daily
((n)) single dose: 322 mg, up to 3 times daily

single dose: 100 g for a full bath, up to 1 bath daily

Route of administration
Oral useUse as bath additive. Temperature: 34-37 °C, duration of bath 10-20 minutes.
Duration of use or any restrictions on the duration of use
If symptoms persist during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.
Any other information necessary for the safe use

Hypersensitivity to the active substance.

Full baths are contraindicated in cases of open wounds, large skin injuries, acute skin diseases, high fever, severe infections, severe circulatory disturbances and cardiac insufficiency.

The use in children under 12 years of age has not been established due to lack of adequate data.

If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

For tinctures and extracts containing ethanol, the appropriate labelling for ethanol, taken from the ‘Guideline on excipients in the label and package leaflet of medicinal products for human use’, must be included.

None reported

Safety during pregnancy and lactation has not been established. In the absence of sufficient data, use during pregnancy and lactation is not recommended.

No fertility data available.

May impair ability to drive and use machines. Affected patients should not drive or operate machinery.

Gastrointestinal symptoms (e.g. nausea, abdominal cramps) may occur after ingestion of valerian root preparations. The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.

None known

If adverse reactions occur, a doctor or a qualified health care practitioner should be consulted.

Valerian root at a dose of approximately 20 g caused symptoms, such as fatigue, abdominal cramp, chest tightness, light-headedness, hand tremor and mydriasis, which disappeared within 24 hours. If symptoms arise, treatment should be supportive.

No case of overdose has been reported.

Not applicable

Not applicable.

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