Article 1
Open ↗Annex II to Decision 2008/911/EC is amended in accordance with the Annex to this Decision.
Source
Commission Implementing Decision (EU) 2016/1658 of 13 September 2016 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2016) 5747) (Text with EEA relevance)
Commission Implementing Decision (EU) 2016/1658 of 13 September 2016 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2016) 5747) (Text with EEA relevance)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Article 2
Open ↗This Decision is addressed to the Member States.
Supplementary provisions
ANNEXSupplementary provisions
Open ↗ANNEX In Annex II to Decision 2008/911/EC, the entry Eleutherococcus Senticosus (Rupr. et Maxim) Maxim., Radix is amended as follows: (1) The section ‘Common name in all EU official languages of herbal substance’ is amended as follows: (a) After ‘FR (français): racine d'éleuthérocoque (racine de ginseng sibérien)’ the following is inserted: ‘HR (hrvatska): Korijen sibirskog ginsenga’ (b) ‘Všehojovcový koreň’ related to SK (slovenčina) is replaced by ‘Koreň eleuterokoka’; (2) The section ‘Herbal preparation(s)’ is amended as follows: (a) ‘Comminuted herbal substance for preparation of herbal tea’ is replaced by ‘Comminuted herbal substance’; (b) ‘Liquid extract (1:1, ethanol 30-40 % v/v)’ is replaced by ‘Liquid extract (DER 1:1, extraction solvent ethanol 30-40 % v/v)’; (c) ‘Dry extract (13-25: 1, ethanol 28-40 % v/v)’ is replaced by ‘Dry extract (DER 13-25:1, extraction solvent ethanol 28-40 % v/v)’; (d) ‘Dry aqueous extract (15-17:1)’ is replaced by ‘Dry aqueous extract (DER 15-17:1)’; (e) ‘Tincture (1:5, ethanol 40 % v/v)’ is replaced by ‘Tincture (ratio of herbal substance to extraction solvent 1:5, extraction solvent ethanol 40 % v/v)’; (3) In the section ‘European Pharmacopoeia monograph reference’‘6.0’ is replaced by ‘7.0’; (4) In the section ‘Type of tradition’‘Chinese, European.’ is replaced by ‘European, Chinese.’; (5) In the section ‘Specified strength’‘Not applicable.’ is replaced by ‘Please see “Specified posology”.’; (6) The section ‘Specified posology’ is amended as follows: (a) ‘over 12 years of age’ is deleted; (b) ‘Daily dose.’ is replaced by ‘Average daily dose.’; (c) ‘The use is not recommended in children under 12 years of age’ is replaced by ‘The use in children under 12 years of age is not recommended’; (7) The section ‘Any other information necessary for the safe use’ is amended as follows: (a) ‘Contra-indications’ is replaced by ‘Contraindication’; (b) The words ‘Arterial hypertension.’ are deleted; (c) The sentence ‘The use in children under 12 years of age is not recommended because sufficient experience is not available’ are replaced by ‘The use in children under 12 years of age is not recommended due to lack of adequate data’; (d) After ‘If the symptoms worsen during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.’ the sentence ‘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.’ is inserted; (e) The title of subsection ‘Pregnancy and lactation’ is replaced by ‘Fertility, pregnancy and lactation’; After the sentence ‘In the absence of sufficient data, the use during pregnancy and lactation is not recommended.’ ‘No fertility data available.’ is inserted; (f) In subsection ‘Undesirable effects’ after ‘The frequency is not known.’ The sentence ‘If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.’ is inserted; (g) After subsection ‘Overdose’ the following subsections are inserted: ‘Pharmaceutical particulars (if necessary) Not applicable. Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product) Not applicable.’
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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
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