L 11/12 Official Journal of the European Union 16.1.2010 COMMISSION DECISION of 28 July 2009 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2009) 5804) (Text with EEA relevance) (2010/28/EC) THE COMMISSION OF THE EUROPEAN COMMUNITIES, (4)  The measures provided for in this Decision are in accordance with the opinion of the Standing Having regard to the Treaty establishing the European Committee on Medicinal Products for Human Use, Community, HAS ADOPTED THIS DECISION: 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 Article 1 1), and i ticular Article 16(f) thereof, use (1), and in particular Article 16(f) thereof, Decision 2008/911/EC is amended as follows: Having regard to the opinions of the European Medicines Agency, formulated on 10 January 2008 and 6 March 2008 1. Annex 1 is amended in accordance with Annex I to this by the Committee for Herbal Medicinal Products, Decision. Whereas: 2. Annex II is amended in accordance with Annex 1II to this Decision. (1) Calendula officinalis L and Pimpinella anisum L comply with the requirements set out in Directive 2001/83/EC. Calendula officinalis L and Pimpinella anisum L can be Article 2 considered as herbal substances, herbal preparations or combinations thereof This Decision is addressed to the Member States. (2) It is therefore appropriate to include Calendula officinalis L and Pimpinella anisum L in the list of herbal substances, Done at Brussels, 28 July 2009. preparations and combinations thereof for use in tradi- ’ tional herbal medicinal products established in Annex I to Commission Decision 2008/911/EC (2). For the Commissi or the Commission (3)  Decision 2008/911/EC should therefore be amended Giinter VERHEUGEN accordingly. Vice-President () OJ L 311, 28.11.2001, p. 67. () O] L 328, 6.12.2008, p. 42.