. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/EEC/296 
3 October 2006 
 (06-4732) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
 
NOTIFICATION 
 
1. Member to Agreement notifying:  EUROPEAN COMMUNITIES
 
If applicable, name of local government involved:   
2. Agency responsible:  Commission of the European Communities.  Health & Consumer 
Protection Directorate-General, Directorate E – Safety of the food chain.  
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):   4-hexylresorcinol, (E 586), alumin ium silicate produced from raw kaolinitic 
clay (E 559), citric acid (E 472c), esters of mono- and diglycerides of fatty acids, ethyl cellulose (E 462), propyl p-hydroxybenzoate (E  216), pullulan (E 1204), sodium propyl p-
hydroxybenzoate (E 217), soybean hemicellu lose (E 426), starch aluminium octenyl 
succinate (E 1452), tertiary-butylhydroqui none (TBHQ- E 319) and any food product 
containing them. Numerous HS positions such as 1108, 2507, 2907, 2916, 2907.22 when circulating for food use.  ICS:  67.220.  
4. Regions or countries likely to be affected , to the extent relevant or practicable:  
Member states of the European Communitie s (EEC) and third countries exporting the 
products concerned to the EEC.  
5. Title, language and number of pages of the notified document:  Commission Document 
SANCO/2006/1849 " Draft Commission Directive amending Directive 96/77/EC laying 
down specific purity criteria on food additives other than colours and sweeteners " 
(13 pages).  
6. Description of content:  The draft Directive  
- adopts the specific purity criteria for E 319 tertiary-butylhydroquinone (TBHQ) (HS 
2907.22), E 426 soybean hemicellulose, E 462 ethyl cellulose (HS 3207), E 586 4-hexylresorcinol (HS 2907), E 1204 pullulan (HS 1108)and E 1452 starch aluminium 
octenyl succinate (HS 1108). 
- Additionally, it withdraws the purity crite ria for E 216 propyl p-hydroxybenzoate and 
E 217 sodium propyl p-hydr oxybenzoate (HS 2916) which are no longer permitted for 
use as food additives. 
- It also updates the specific purity criteria for E 472c citric acid esters of mono- and 
diglycerides of fatty (HS 2918) acids in order to cover partially or wholly neutralised 
products.  
- Introduces the requirement for E 559 aluminium silicate to be produced from raw 
kaolinitic clay (HS 2507) whose content of dioxin should be restricted to the lowest 
possible level. G/SPS/N/EEC/296 
Page 2  
 
  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   
8. International standard, guideline or recommendation: 
[ X ] Codex Alimentarius Commission,  [   ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention,  [   ] None 
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:  The draft takes into account the specifications 
established by international bodies (JECFA (J oint FAO/WHO Expert Committee on Food 
Additives)). 
9. Relevant documents and language(s) in which these are available:  European 
Commission Document SANCO/2006/1849 (available in English). When a dopted it will be 
published at the Official Journal available at: ( http://europa.eu.int/eur-
lex/lex/JOYear.do?year=2006 ) 
The scientific risk assessments related to the safety in use of the concerned food additives are 
available at: 
http://www.efsa.eu.int/scie nce/afc/afc_opinions/641/ opinion_afc17_ej84_tbhq_v2_en1.pdf 
http://ec.europa.eu/food/ fs/sc/scf/out 187_en.pdf 
http://www.efsa.eu.int/sc ience/afc/afc_opinions/ 410/opinion_afc_08_en1.pdf 
http://ec.europa.eu/food/ fs/sc/scf/out 170_en.pdf 
http://www.efsa.eu.int/scienc e/afc/afc_opinions /629/opinion_afc15_ej 85_pullulan_en1.pdf 
http://ec.europa.eu/food/fs/sc/sc f/reports/scf_r eports_43.pdf 
http://www.efsa.europa.eu/sc ience/afc/afc_opinions/630/ opinion_afc16_ej83_parabens_v2_en
1.pdf  
10. Proposed date of adoption:  November 2006 (at this time is not possible to estimate a 
more specific date). 
11. Proposed date of entry into force:  20 days as of publication in the Official Journal. 
12. Final date for comments:  Sixty (60) days after the date of notification.  Comments are 
welcome at any time.  They will be considered at the occasion of a new modification of Directive 96/77/EC laying down specific purity criteria on food additives other than colours 
and sweeteners. 
Agency or authority designated to handle comments:  [ X ] National notification 
authority, [   ] 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: