WORLD TRADE  
ORGANIZATION  G/SPS/N/EEC/372 
15 March 2010 
 (10-1362) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
1. Notifying Member:  EUROPEAN UNION
 
If applicable, name of local government involved:    
2. Agency responsible:  Commission of the European Communities.  Health & Consumers 
Directorate-General  Directorate E – Safety of the Food Chain 
3. Products covered (provide tariff item numbe r(s) as specified in national schedules 
deposited with the WTO;  ICS numbers should be provided in addition, where 
applicable):  Bivalve molluscs (HS Codes 03.01, 03.01.10) 
4. Regions or countries likely to be affected, to the extent relevant or practicable: 
[ ] All trading partners   
[X] Specific regions or countries:  EU member States and third countries exporting 
these products to the European Union  
5. Title of the notified document:  "Draft Commission Regulation of *** amending 
Regulation (EC) No 2074/2005 as regards recogni zed testing methods for detecting marine 
biotoxins in live bivalve molluscs"  Language:  English  Number of pages:  7 
http://members.wto.org/crnattach ments/2010/sps/EEC/10_1028_00_e.pdf  
6. Description of content:  Regulation (EC) No 854/2004 lays down specific rules for the 
organization of official controls on products  of animal origin and Regulation (EC) 
No 853/2004 lays down specific requirements concerning hygiene rules for food of animal 
origin.  Implementing measures for those Regulations as regards recognized testing 
methods for marine biotoxins are set out in Commission Regulation (EC) No 2074/2005 of 5 December 2005 laying down implementing measures for certain products.
1  I t  i s  
necessary to modify those implementing measur es in the light of new scientific evidence. 
The proposal aims to substitute the biologi cal testing method for DSP toxins with the 
alternative method LC-MS. 
7. Objective and rationale:  [X] food safety, [ ] animal health, [ ] plant protection, 
[X] protect humans from animal/plant pest or  disease, [ ] protect territory from other 
damage from pests.    
8. Is there a relevant international stan dard?  If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex standard 
or related text) Standard for live and raw bivalve molluscs – CODEX STAN 292-
2008 
                                                      
1 OJ L 338, 22.12.2005, p. 27 G/SPS/N/EEC/372 
Page 2  
 
  [ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] International Plant Protection Convention (e.g. ISPM number)    
[ ] None Does this proposed regulation conform to the relevant international standard?   
 [ ] Yes   [X] No 
 If no, describe, whenever possible, how and why it deviates from the 
international standard:  New scientific advice has demonstrated the need to review the 
EU approach as regards marine biotoxins.  Ma jor shortcomings of the mouse bioassay were 
in particular identified which justified the pr oposed changes.  The European Union intends 
to contribute to the on-going discussions at Codex level at the working group in charge of 
the draft list of methods for the determination of biotoxins in bivalve molluscs. 
9. Other relevant documents and language (s) in which these are available:  Commission 
Regulation (EC) No 2074/2005 of 5 December  2005 laying down implementing measures 
for certain products under Regulation (EC) No 853/2004 of the European Parliament and of 
the Council and for the organisation of o fficial controls under Regulation (EC) 
No 854/2004 of the European Parliament and of the Council and Regulation (EC) 
No 882/2004 of the European Parliament a nd of the Council, derogating from Regulation 
(EC) No 852/2004 of the European Par liament and of the Council and amending 
Regulations (EC) No 853/2004 and (EC) No 854/2004. http://eur-
lex.europa.eu/LexUriServ/LexUriSer v.do?uri=OJ:L:2005:338:0027:0059:EN:PDF  
EFSA opinion on "Marine biotoxins in shellfish – Summary on Regulated Marine 
Biotoxins"; adopted: 13 August 2009. http://www.efsa.europa.eu/en/scdocs/scdoc/1306.htm
 
10. Proposed date of adoption (dd/mm/yy) :  July 2010 
Proposed date of publication (dd/mm/yy) :  October 2010 
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  This Regulation shall enter into force on the 20th day following that of its 
publication in the Official Journal of the European Union. 
[ ] Trade facilitating measure   
12. Final date for comments:  [X] Sixty days  from the date of circulation of the 
notification and/or (dd/mm/yy) :  14 May 2010 
Agency or authority designated to handle comments:  [X] National Notification 
Authority, [X] National Enquiry Point.  Address, fax number and e-mail address (if 
available) of other body:   
European Commission 
DG Health and Consumers, Unit D3 - In ternational questions (multilateral)  
Rue Froissart 101,  1049 Brussels, Belgium 
Tel:  +32 (0)2 29 68185/59922 Fax:  +32 (0)2 29 98090  E-mail:  sps@ec.europa.eu  G/SPS/N/EEC/372 
 Page 3 
 
 
  13. Texts available from:  [X] National Notification Authority, [X] National Enquiry 
Point.  Address, fax number and e-mail address (if available) of other body:    
European Commission 
DG Health and Consumers, Unit D3 - In ternational questions (multilateral)  
Rue Froissart 101,  1049 Brussels, Belgium 
Tel:  +32 (0)2 29 68185/59922 
Fax:  +32 (0)2 29 98090  E-mail:  sps@ec.europa.eu