Date: 2016-09-15Category: Not ApplicableState: Union GovernmentCountry: Europe
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)
Executive Summary:
Commission Implementing Decision (EU) 2016/1658 amends Decision 2008/911/EC, updating the list of herbal substances, preparations, and combinations for use in traditional herbal medicinal products. The amendment, based on the European Medicines Agency's opinion, revises the entry for Eleutherococcus senticosus Rupr. et Maxim Maxim. This decision was adopted on September 13, 2016, and is addressed to the Member States.
Key Points / Main Content:
Amendments to Annex II of Decision 2008/911/EC concerning Eleutherococcus Senticosus Rupr. et Maxim Maxim., Radix:
* **Common Name:**
* Addition of "Korijen sibirskog ginsenga" in Croatian (hrvatska).
* "Vehojovcov kore" related to Slovak (slovenina) is replaced by "Kore eleuterokoka".
* **Herbal Preparations:**
* "Comminuted herbal substance for preparation of herbal tea" is replaced by "Comminuted herbal substance".
* "Liquid extract 1:1, ethanol 30-40 % v/v" is replaced by "Liquid extract DER 1:1, extraction solvent ethanol 30-40 % v/v".
* "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".
* "Dry aqueous extract 15-17:1" is replaced by "Dry aqueous extract DER 15-17:1".
* "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".
* **European Pharmacopoeia:**
* Monograph reference updated from "6.0" to "7.0".
* **Tradition Type:**
* Changed from "Chinese, European" to "European, Chinese."
* **Specified Strength:**
* "Not applicable" is replaced by "Please see Specified posology."
* **Specified Posology:**
* "Over 12 years of age" is deleted.
* "Daily dose" is replaced by "Average daily dose".
* "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".
* **Safe Use Information:**
* "Contraindications" is replaced by "Contraindication."
* "Arterial hypertension" is deleted from contraindications.
* "The use in children under 12 years of age is not recommended because sufficient experience is not available" is replaced by "The use in children under 12 years of age is not recommended due to lack of adequate data".
* Requirement to include appropriate labeling for ethanol in tinctures and extracts.
* "Pregnancy and lactation" is replaced by "Fertility, pregnancy and lactation," with a note that "No fertility data available." is added.
* A sentence is inserted to consult a doctor if other adverse reactions occur.
* **Additional Information:**
* Addition of subsections for "Pharmaceutical particulars if necessary" and "Pharmacological effects or efficacy plausible on the basis of longstanding use and experience if necessary for the safe use of the product," both marked "Not applicable."
Impact Analysis:
**Member States:**
* Impact: Required to implement the updated list of herbal substances, preparations, and combinations thereof for use in traditional herbal medicinal products.
* Action Required: Amend national regulations and ensure compliance with the updated Annex II of Decision 2008/911/EC.
**Manufacturers of Traditional Herbal Medicinal Products:**
* Impact: Must comply with the revised specifications for Eleutherococcus senticosus, including updated extraction solvent ratios, labelling requirements, and contraindications.
* Action Required: Review product formulations, labelling, and safety information to ensure compliance with the updated requirements. Update product information and usage guidelines accordingly.
**European Medicines Agency (EMA) and Committee for Herbal Medicinal Products:**
* Impact: The EMA's opinion and the Committee's review led to the changes, ensuring the list remains relevant and safe.
* Action Required: Continue to monitor and review monographs and list entries to maintain accuracy and relevance.
**Healthcare Practitioners:**
* Impact: Need to be aware of the updated contraindications, posology, and safety information for products containing Eleutherococcus senticosus.
* Action Required: Update knowledge of the revised product information and advise patients accordingly, especially regarding use in children, pregnancy, and lactation.
**Consumers:**
* Impact: Access to safer and better-labelled herbal medicinal products containing Eleutherococcus senticosus.
* Action Required: Read and follow updated product information and consult with healthcare practitioners for safe and effective use.
Key Entities Referenced
European Union: Political and economic union of European countries.
European Commission: The executive branch of the European Union responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Directive 2001/83/EC: Directive of the European Parliament and of the Council on the Community code relating to medicinal products for human use.
European Medicines Agency: A decentralised agency of the European Union responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.
Commission Decision 2008/911/EC: Commission Decision establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products.
Committee for Herbal Medicinal Products: A committee within the European Medicines Agency responsible for scientific opinions on herbal medicinal products.
Eleutherococcus senticosus: Botanical name of Siberian ginseng, a herbal substance.
Brussels: The de facto capital city of the European Union, located in Belgium, where the decision was adopted.
15.9.2016 EN Official Journal of the European Union L 247/19
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)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the
Community code relating to medicinal products for human use (1), and in particular Article 16f thereof,
Having regard to the opinion of the European Medicines Agency, formulated on 25 March 2014 by the Committee for
Herbal Medicinal Products,
Whereas:
(1) In 2008 an opinion of the European Medicines Agency established that Eleutherococcus senticosus (Rupr. et Maxim)
Maxim complied with the requirements set out in Directive 2001/83/EC as a herbal substance, a herbal
preparation or a combination thereof within the meaning of that Directive and it was therefore included in the
list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products
established by Commission Decision 2008/911/EC (2).
(2) As part of its review of monographs and list entries to keep them relevant, the Committee for Herbal Medicinal
Products has reviewed the list entry Eleutherococcus senticosus (Rupr. et Maxim) Maxim and adopted an opinion to
change the list entry with regard to the name of the herbal substance in certain EU official languages, the
phrasing of the herbal preparations, update of the reference to the European Pharmacopoeia and update of some
information necessary for the safe use, e.g. revision of the contraindications. Some of those changes are the result
of an update of the template for list entries.
(3) Decision 2008/911/EC should therefore be amended accordingly.
(4) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on
Medicinal Products for Human Use,
HAS ADOPTED THIS DECISION:
Article 1
Annex II to Decision 2008/911/EC is amended in accordance with the Annex to this Decision.
Article 2
This Decision is addressed to the Member States.
Done at Brussels, 13 September 2016.
For the Commission
Vytenis ANDRIUKAITIS
Member of the Commission
(1) OJ L 311, 28.11.2001, p. 67.
(2) Commission Decision 2008/911/EC of 21 November 2008 establishing of a list of herbal substances, preparations and combinations
thereof for use in traditional herbal medicinal products (OJ L 328, 6.12.2008, p. 42).L 247/20 EN Official Journal of the European Union 15.9.2016
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;15.9.2016 EN Official Journal of the European Union L 247/21
(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.’