
Article 1 
The substance Urtica spp. as specified in Annex I is approved as a basic substance subject to the conditions laid down in that Annex.
Article 2 
Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 9 March 2017.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX I

Common Name, Identification Numbers IUPAC Name Purity Date of approval Specific provisions
Urtica spp.CAS No 84012-40-8 (Urtica dioica extract)CAS No 90131-83-2 (Urtica urens extract) Urtica spp. European Pharmacopeia 30 March 2017 Urtica spp. shall be used in accordance with the specific conditions included in the conclusions of the review report on Urtica spp. (SANTE/11809/2016) and in particular Appendices I and II thereof.

ANNEX II

In Part C of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

Number Common Name, Identification Numbers IUPAC Name Purity Date of approval Specific provisions
‘14 Urtica spp.CAS No 84012-40-8 (Urtica dioica extract)CAS No 90131-83-2 (Urtica urens extract) Urtica spp. European Pharmacopeia 30 March 2017 Urtica spp. shall be used in accordance with the specific conditions included in the conclusions of the review report on Urtica spp. (SANTE/11809/2016) and in particular Appendices I and II thereof.’

