EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10862/2018 
(POOL/E1/2018/10862/10862 -EN.doc)  
D057837/01  
[…](2018) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and 
of the Council as regards Yohimbe ( Pausinystalia yohimbe  (K. Schum) Pierre ex Beille)  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and 
of the Council as regards  Yohimbe ( Pausinystalia yohimbe  (K. Schum) Pierre ex Beille)  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No 1925/2006 of the European Parliament and of the 
Council of 20 December 2006 on the addition of vitamins and minerals and of certain other 
substances to foods1, and in particular Article 8  (5) thereof,  
Whereas:  
(1) In accordance with Article 8(2) of Regulation (EC) No 1925/2006 , taking into accoun t 
the possible harmful effects on  health associated with the use of Yohimbe 
(Pausinystalia yohimbe (K. Schum) Pierre ex Beille) and its preparations in foods , and 
the persisting scientific uncertainty, this  substance has been placed under Union 
scrutiny and was included in Part C of Annex III to Regulation (EC) No 1925/2006 by 
means of Regulation (EU) No 2015/4032. 
(2) Pursuant to Article 8(5) of Regulation (EC) No 1925/2006, within four years from the 
date a substance has been listed in Part C of Annex III, a decision shall be taken to 
generally allow the use of a substance listed in Part C of Annex III or to list it in Part 
A or B of Annex III, as appropriate, taking into account the opinion of the European 
Food Safety Authority  (‘the Authority’)  on any file s submitted for evaluation by food 
business operators, or any other interested parties as mentioned in Article 8(4) . 
(3) Pursuant to Article 5(2) of Commission Implementing Regulation (EU) No  307/20123, 
only files submitted within 18 months from the entry into  force of a decision that 
includes a substance to Part C of Annex III to Regulation (EC) No  1925/2006 shall be 
taken into account by the Authority as being a valid file for the purposes of a decision 
as laid down  in Article 8(5)  of Regulation (EC) No 1925/ 2006.  
(4) Considering that i nterested parties have not submitted any scientific data to the 
Authority to demonstrate the safety of Yohimbe ( Pausinystalia yohimbe (K. Schum) 
Pierre ex Beille) within the time limit referred to in Article 5(2) of Implementing 
Regulation (EU) No 307/2012,  Yohimbe ( Pausinystalia yohimbe  (K. Schum) Pierre ex 
                                                 
1 OJ L 404, 30.12.2006, p. 26.  
2 Commission Regulation (EU) 2015/403 of 11 March 2015 amending Annex III to Regulation (EC) 
No 1925/2006 of the European Parliament and of the Council as regard s Ephedra species and Yohimbe 
(Pausinystalia yohimbe  (K. Schum) Pierre ex Beille , OJ L 67, 12.3.2015, p. 4.  
3 Commission Implementing Regulation (EU) No 307/2012 of 11 April 2012 establishing implementing 
rules for the application of Article 8 of Regulation (EC) No 1925/2006 of the European Parliament and 
of the Council on the addition of vitami ns and minerals and of certain other substances to foods,  
OJ L 102, 12.4.2012, p. 2.   
EN 2  EN Beille) and its preparations  should be included in Part A of Annex III to Regulation 
(EC) No 1925/2006, which means that their use in food will be prohibited.  
(5) Regulation (EC) No  1925 /2006 should therefore be amended accordingly.  
(6) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex III to Regulation (EC) No 1925/2006 is amended as follows:  
(1) in Part A, the following entry is added:  
‘Yohimbe bark and its preparations originating from Yohimbe ( Pausinystalia 
yohimbe (K. Schum) Pierre ex Beille)’;  
(2) in Part C, the following entry is deleted:  
‘Yohimbe bark and its preparations originating from Yohimbe ( Pausinystalia 
yohimbe (K. Schum) Pierre ex Beille)’.  
Article 2  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the Europea n Union.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER