. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/EU/84 
9 January 2013  
 (13-0105) 
Committee on Technical Barriers to Trade Original:   English 
  
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local governme nt involved (Article 3.2 and 7.2):     
2. Agency responsible:  European Commission 
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above :   
European Commission 
EU-TBT Enquiry Point Fax:  +(32) 2 299 80 43 E-mail:  mailto:eu-tbt@ec.europa.eu  
Website: http://ec.europa.eu/enterprise/tbt/  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:   
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable):  Foods and food 
ingredients with added phytosterols, phytoster ol esters, phytostanol s and/or phytostanol 
esters. 
5. Title, number of pages and language(s) of the notified document:  Draft Commission 
Regulation amending Regulation (EC) No 608/ 2004 concerning the labelling of foods and 
food ingredients with added phytosterols, phytost erol esters, phytostanols and/or phytostanol 
esters (4 pages, in English). 
6. Description of content:  Commission Regulation (EC) No 608/2004 provides that the 
labelling of foods with added phytosterols, phyto sterol esters, phytostanols and/or phytostanol 
esters shall contain, amongst ot hers, a statement that the produc t is intended exclusively for 
people who want to lower their blood choles terol level. The purpose of this mandatory 
statement is to ensure that the product reac hes its target group, and therefore to avoid 
unnecessary consumption by non-targeted groups.  
Certain health claims on food labels relati ng to the reduction and maintenance of blood 
cholesterol with respect to foods containing plant sterols and plant stanols have  recently been 
authorised at EU level, subject to certain cond itions of use. The wording of these claims could 
potentially confuse consumers as to the effe cts of phytosterols and phytostanols on blood 
cholesterol. 
Therefore, the draft Commission Regulation am ends the mandatory statement laid down in 
Regulation (EC) No 608/2004 to address these concerns while ensuring that its wording 
serves adequately the informative purpose  for which it was originally introduced. G/TBT/N/EU/84 
Page 2  
 
  7. Objective and rationale, including the na ture of urgent problems where applicable:  
Consumer information.  
8. Relevant documents:   Commission Regulation (EC) No  608/2004 concerning the labelling 
of foods and food ingredients with added phytost erols, phytosterol esters, phytostanols and/or 
phytostanol esters  http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=OJ :L:2004:097:0044:0045:EN:PDF  
Commission Regulation (EC) No 983/2009 on the au thorisation and refusal of authorisation 
of certain health claims  made on food and referring to the reduction of disease risk and to 
children's development and health  
"http://eur-
lex.europa.eu/LexUriServ /LexUriServ.do?uri=CON SLEG:2009R0983:20100524:EN:PDF " 
Commission Regulation (EU) No 384/2010 on the au thorisation and refusal of authorisation 
of certain health claims made on foods and referring to the reduction of disease risk and to 
children's development and health  
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=OJ :L:2010:113:0006:0010:EN:PDF  
Commission Regulation (EU) No 432/2012 establ ishing a list of permit ted health claims 
made on foods, other than those referring to th e reduction of disease risk and to children's 
development and health  http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=OJ :L:2012:136:0001:0040:EN:PDF  
9. Proposed date of adoption:   
Proposed date of entry into force:    By mid-2013 
20 days from publication in the Official Journal 
of the EU (about a month after adoption 
approx.) A transitional period of 6 months is foreseen in Article 2 of  the draft Regulation. 
10. Final date for comments:  60 days from date of notification. 
11. Text available from:  National enquiry point [  ], or address, telephone and fax numbers, 
e-mail and web-site addresses, if available of the other body:    
European Commission 
EU-TBT Enquiry Point Fax:  + (32) 2 299 80 43 
E-mail:  mailto:eu-tbt@ec.europa.eu  
The text is available on the EU-TBT Website:  http://ec.europa.eu/enterprise/tbt/  
http://members.wto.org/crnatt achments/2013/TBT/EEC/13_0005_00_e.pdf