Commission Decision
of 25 March 2010
on 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(2010) 1867)
(Text with EEA relevance)
(2010/180/EU)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on European Union and 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 use1, and in particular Article 16f thereof,
Having regard to the opinion of the European Medicines Agency, formulated on 6 November 2008 by the Committee for Herbal Medicinal Products,
Whereas:
Mentha x piperita L. can be considered as a herbal substance, a herbal preparation or a combination thereof within the meaning of Directive 2001/83/EC and complies with the requirements set out in that Directive.
It is therefore appropriate to include Mentha x piperita L. in the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products established by Commission Decision 2008/911/EC2.
In order to avoid duplications and possible contradictions between the Annexes and Articles 1 and 2 of Decision 2008/911/EC, it is appropriate to remove the references to single substances in those Articles.
Decision 2008/911/EC should therefore be amended accordingly.
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: