EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANCO/11379/2014 CIS (POOL/E4/2014/11379/11379-EN CIS.doc) […](2014) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Annex III to Regulati on (EC) No 1925/2006 of th e European Parliament and 
of the Council as regards Ephedra species and Yohimbe (Pausinystalia yohimbe (K. 
Schum) Pierre ex Beille) 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Annex III to Regulation (EC) No  1925/2006 of the European Parliament and 
of the Council as regards Ephedra species and 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 v itamins and minerals and of certain other 
substances to foods
1, and in particular Article 8(2) thereof, 
Whereas: (1) Pursuant to Article 8(2) of Regula tion (EC) No 1925/2006, a Member State may 
request the Commission to initiate a procedur e to include a substanc e or an ingredient 
containing a substance other than a vitamin or a mineral in Annex III to Regulation 
(EC) No 1925/2006 listing the substances whos e use in foods is prohibited, restricted 
or under Union scrutiny, if that substance is associated with a potential risk to 
consumers as defined by Article 8( 1) of Regulation (EC) No 1925/2006. 
(2) On 7 September 2009, Germany sent a request to the Commission regarding the 
possible harmful effects associated  with the intake of Yohimbe ( Pausinystalia 
yohimbe  (K. Schum) Pierre ex Beille) and Ephedra  species and their preparations, and 
asked the Commission to initiate the proce dure under Article 8 of  Regulation (EC) No 
1925/2006 for those two substances.  
(3) The request by Germany fulfilled the necessa ry conditions and requirements laid down 
in Articles 3 and 4 of Commission Im plementing Regulation (EU) No 307/2012
2.  
(4) On 9 September 2011, the Commission asked the European Food Safety Authority 
(hereafter ‘the Authority’) to evaluate the safety in use of Ephedra  andYohimbe 
(Pausinystalia yohimbe (K. Schum ) Pierre ex Beille) species in food.  
                                                 
1 OJ L 404, 30.12.2006, p. 26. 
2 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 of 20 December 2006 on the addition of vitamins and minerals and of certain other 
substances to foods (OJ L 102, 12.4.2012, p. 2).  
EN 3   EN (5) On 3 July 2013, the Authority adopted a sc ientific opinion on the evaluation of the 
safety in use of Yohimbe ( Pausinystalia yohimbe (K. Schum ) Pierre ex Beille)3. It 
concluded that the chemical and toxicological characterisa tion of yohimbe bark and its 
preparations used in food originating from Yohimbe ( Pausinystalia yohimbe (K. 
Schum ) Pierre ex Beille) are not ad equate to conclude on thei r safety as ingredients of 
food. Therefore, it was not possible for th e Authority to provide advice on a daily 
intake of yohimbe bark and its preparations that does not give rise to concerns for 
human health.  
(6) On 6 November 2013, the Authority adopted a scientific opinion on the safety 
evaluation of Ephedra species for use in food4. It found that although the marketing of 
foods containing Ephedra herb and its preparations in reta il outlets is not documented 
in Europe, food supplements containing Ephedr a herbs or their prep arations that are 
typically used for weight loss and athletic performance can easily be purchased via the 
internet. The Authority concluded that it cannot be excluded that consumers may 
purchase herbal tea from Ephedra herb via the internet. Given that Ephedra herb and 
its preparations are marketed almost excl usively as food supplements, the Authority 
calculated potential exposure levels to th e herb from food supplements. It concluded 
that Ephedra herb and its preparations in  food supplements may result in exposure to 
total ephedra alkaloids or ephedrine which falls within or may exceed the therapeutic dose ranges for the individual ephedra alkalo ids or ephedrine, in medicinal products. 
(7) The Authority concluded that due to the abse nce of adequate toxicity data, it could not 
provide advice on a daily intake of Ephedra herb and its preparations from all foods 
that does not give rise to concerns for hu man health. Nevertheless, it concluded that 
exposure to total ephedra alka loids or ephedrine in foods, mainly in food supplements 
could lead to severe adverse effects on th e cardiovascular and central nervous systems 
(such as hypertension and stroke), which may be enhanced in combination with 
caffeine. Therefore, the use of Ephedra he rb and its preparations containing ephedra 
alkaloids in food is of significant safety concern for human health. 
(8) The Commission received no comments from in terested parties fo llowing publication 
by the Authority of  its opinions on Ephedra species and on Yohimbe ( Pausinystalia 
yohimbe (K. Schum ) Pierre ex Beille.  
(9) As there is a possibility of harmful eff ects on health associated with the use of 
Yohimbe ( Pausinystalia yohimbe (K. Schum ) Pierre ex Beille) and its preparations in 
foods, but scientific uncertain ty persists, the substance should be placed under Union 
scrutiny and therefore, should be included in  Part C of Annex III to Regulation (EC) 
No 1925/2006. Consequently, during the peri od of Union scrutiny and pending a 
decision on whether to allow the use of the subs tance or to place it in Part A or Part B 
of Annex III to Regulation (EC) No 1925/ 2006 at the end of the scrutiny period, 
national provisions regula ting the use of Yohimbe ( Pausinystalia yohimbe (K. Schum ) 
Pierre ex Beille) in food should still apply.  
                                                
 
3 EFSA Panel on Food Additives and Nutrient Sources  added to Food (ANS); Scientific Opinion on the 
evaluation of the safety in use of Yohimbe ( Pausinystalia yohimbe  (K.Schum.)Pierre ex Beille). EFSA 
Journal 2013;11(7):3302. 
4 EFSA Panel on Food Additives and Nutrient Sour ces added to Food (ANS); Scientific Opinion on 
safety evaluation of Ephedra species for use in food. EFSA Journal 2013;11(11):3467.  
EN 4   EN (10) Considering the significant safety concern associated with the use of Ephedra herb and 
its preparations in foods, in particular with regard to e xposure to ephedra alkaloids 
present in food supplements, and considering that no daily intake of Ephedra herb and 
its preparations that does not give rise to concerns for hum an health could be set, the 
use of that substance in foods should be prohibited. Therefore, Ephedra herb and its 
preparations should be included in Anne x III, Part A of Regulation (EC) No 
1925/2006.  
(11) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Animal Health, 
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: 
“Ephedra herb and its preparations or iginating from Ephedra species”  
(2) In Part C, the following entry isadded: 
“Yohimbe bark and its preparations orig inating from Yohimbe (Pausinystalia 
yohimbe (K. Schum) Pierre ex Beille)”  
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, 
 For the Commission 
 José Manuel BARROSO  The President