G/SPS/N/AUS/568  
7 July 2023  
(23-4608) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION  
1. Notifying Member:  AUSTRALIA  
If applicable, name of local government involved:   
2. Agency responsible:  Food Standards Australia New Zealand (FSANZ)  
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):  Foods (bivalve molluscs) sold in Australia (both imported and 
domestically produced)  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Assessment (Call for Submissions report and supporting 
document(s)) for Application A1243 Harmonisation of marine biotoxin sta ndards for 
bivalve shellfish . Language(s):  English . Number of pages:  24 
https://www.foodstandards.gov.au/code/applications/Pages/A1243Harmonisation -of-
marine -biotoxin -standards -for-bivalve -shellfish -.aspx  
6. Description of content:  To align with international standards and to protect public health 
and safety, FSANZ has drafted an amendment to the Australia New Zealand Food 
Standards Code to amend the maximum levels (MLs) for diarrhetic shellfish toxins 
(DST)  and paralytic shellfish t oxins  (PST) with the equivalent MLs set by the Codex 
Alimentarius Commission (Codex) and with those set in New Zealand.  
MLs for marine biotoxins are necessary in order to protect public health and safety, as 
marine biotoxins cause serious and sometimes lon g-term toxicity in humans.  
The proposed changes are:  
− Lower the ML for DST, expressed as okadaic acid equivalent, from 0.20 to 0.16 mg/kg 
in bivalve molluscs ; 
− Define PST in mg saxitoxin dihydrochloride equivalents/kg rather than mg saxitoxin 
equivalents/kg.  The net effect of this change to a more specific reporting unit is to 
lower the ML for PST from 0.8 to approximately 0.6 mg/kg.  
All applications to change the Australia New Zealand Food Standards Code , must be 
assessed in the context of the following obje ctives:  
a. the protection of public health and safety;  
b. the provision of adequate information relating to food to enable consumers to make 
informed choices; and  
c. the prevention of misleading or deceptive conduct. FSANZ must also have regard to 
the promotion of consistency between domestic an international foods standards.  
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.   G/SPS/N/AUS/568  
 
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  8. Is there a relevant international standard? If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) : Codex Standard for Live and Raw Bivalve Molluscs: 
CODEX STAN 292 -2008 
[ ] 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?  
[X] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language(s) in which these are available:  
Australia  New Zealand Food Standards Code  (available in English)  
10. Proposed date of adoption (dd/mm/yy) : Notification to Australian and New Zealand 
Government anticipated early November 2023 with adoption (gazettal) to follow 
approximately three  months later, pending Government consideration. S ee Item 11 below.  
Proposed date of publication (dd/mm/yy) : 6 July 2023  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : Mid January 2025, after a one year transition period.  
[X] Trade facilitating measure   
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 5 September 2023  
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:   
Food Standards Australia New Zealand  
PO Box 5423  
KINGSTON ACT 2604  
Australia  
E-mail: standards.management@foodstandards.gov.au  
13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
Documents are available from the Food Standards Australia New Zealand website: 
https://www.foo dstandards.gov.au/code/applications/Pages/A1243Harmonisation -of-
marine -biotoxin -standards -for-bivalve -shellfish -.aspx . 
Copies are also available from:  
The Australian SPS Notification Authority  
GPO Box 858  
CANBERRA ACT 2601  
Australia  
E-mail: sps.contact@agriculture.gov.au