. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/EEC/255 
16 February 2005 
 (05-0647) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION OF EMERGENCY MEASURES 
 
1. Member to Agreement notifying:  EUROPEAN COMMUNITIES
 
If applicable, name of local government involved:        
2. Agency responsible:  Commission of the European Co mmunities. Health & Consumer 
Protection Directorate-General  Directorate E – Food Safety: Plant Health, Animal Health 
and Welfare, International questions  
3. Products covered (provide tariff item number(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where 
applicable):  Chemically defined flavouring substances for use in foodstuffs. (ICS 
67.220.20)  
4. Regions or countries likely to be affected , to the extent relevant or practicable:  
Member States of the European Communiti es (EC) and third countries exporting the 
products concerned to the EC  
5. Title, language and number of p ages of the notified document:  European Commission 
Document SANCO/2005/292 "Draft Commission Decision amending Commission 
Decision 1999/217/EC adopting a register of fla vouring substances used in or on foods", 11 
pages, available in English.  When adopted  it will be published at the Official Journal 
available at:  http://europa.eu.int/eur-lex/en/oj/index.html . 
6. Description of content:  Subsequent to the evaluation programme set by Commission 
Regulation (EC) No 1565/2000 of 18 July 2000 la ying down the measures necessary for the 
adoption of an evaluation programme in applicat ion of Regulation (EC) No 2232/96 of the 
European Parliament and of the Council  the following substances do not comply with the 
general criteria for the use of flavouri ng substances set out in the Annex to Regulation (EC) 
No 2232/96 of the European Parliament and of the Council of 28 October 1996 laying down a 
Community procedure for flavouring substances us ed or intended for use in or on foodstuffs . 
- Propyl 4-hydroxybenzoate ( FL 09.915, Propyl Paraben).  
- Pentane-2,4-dione (FL 07.191)  
As a consequence, they should be deleted from the register of allowed substances.  
7. Objective and rationale:  [  X ] food safety,  [    ] animal health,  [    ] plant protection,
[   ] protect humans from animal/plant pest or disease,  [    ] protect territory from 
other damage from pests       G/SPS/N/EEC/255 
Page 2  
 
 8. Nature of the urgent problem(s) and reasons for urgent action:        
- Propyl 4-hydroxybenzoate (FL 09.915, Propy l Paraben) has been shown to have 
effects on the production of sex hormones and on male reproductive organs in 
juvenile rats  
- Pentane-2,4-dione (FL 07.191) has been shown to be genotoxic in vitro  and in vivo  
9. International standard, guideline or recommendation: 
[   ] Codex Alimentarius Commission,  [   ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention,  [ X ] None 
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:  Note that the European Food Safety Authority 
(EFSA) was unable to recommend an  ADI for these substances because of the lack of clarity 
in assessing the no-observed-a dverse-effect-level (NOAEL).  
10. Relevant documents and language(s) in which these are available:   
The full text of the Scientific opinion (available in English) is accessible at EFSA site: 
http://www.efsa.eu.int/science/ afc/afc_opinions/630_en.html  
A Press Release (29 September 2004) of the Eu ropean Food Safety Authority "EFSA advises 
on the safety of paraben usage in food" available in  
http://www.efsa.eu.int/press_room/press _release/631/pr_afc01_parabens_en1.pdf   
For a summary of the Opinion, go to: 
http://www.efsa.eu.int/scienc e/afc/afc_opinions /630/opinion_afc16_ej 83_parabens_summary
_v2_en1.pdf   
The scientific opinion concerning the Pentane-2,4- dione is to be published on the EFSA site 
very soon.  
11. Date of entry into force/period of application (as applicable):  February 2005  
12. Agency or authority designated to handle comments:  [   ] National notification 
authority,  [ X ] National enquiry point, or address, fax number and E-mail address (if 
available) of other body:        
13. Texts available from:  [    ] National notification authority, [  X ] National enquiry 
point, or address, fax number and E-mail address (if available) of other body: