Businesses that don’t need to meet these extra requirements
The requirements of Standards 4.2.1 do not apply to businesses processing bivalve molluscs or seafood as part of:
retail sale direct to the customer; or
restaurant, food service or other food businesses that produce food for direct sale or consumption.
Other businesses that are excluded from the requirements of Standard 4.2.1 – Seafood:
manufacturing of seafood
live storage of seafood at retailers or restaurants. Refer to FSANZ Safe Seafood Australia for live storage guidance to ensure that safety and suitability are not adversely affected.
Food Safety Management System: Bivalve molluscs
A Food Safety Management System (FSMS) is the systematic examination of your business’s processing operations. It allows you to identify potential hazards and implement control measures to address the hazards.
Due to the higher food safety risks of filter feeding bivalve molluscs, businesses involved in their primary production, processing and manufacture are required to implement a documented FSMS. When processing bivalve molluscs, the co-mingling of batches is prohibited, and the FSMS must reflect this control.
Your business's FSMS must be verified (audited) by SA Health (Food and Controlled Drugs Branch) as per the assigned frequency, which will be between 3 to 12 months, based on the performance of the business. This will be in addition to local government Food safety inspections conducted by an Environmental Health Officer.
Businesses are responsible for any auditing costs that may be incurred.
If the business stops conducting the activity that requires a FSMS, SA Health will no longer need to audit the process.
Third party audits e.g. HACCP Certification audits will not be accepted by SA Health.
Wholesalers that sell pre-packed bivalve molluscs without other processing
Seafood businesses that are only storing and dispatching/transporting prepacked bivalve molluscs ie there is no other processing or manufacturing, will not be required to implement a FSMS. However, these businesses must comply with the documented traceability requirements for seafood processors.
SA Health recognises that if an importer/wholesaler only stores and dispatches pre-packaged bivalve molluscs they are not considered to be high risk. These businesses do not need to control co-mingling (co-mingling of bivalve molluscs is prohibited by Standards 4.2.1), and the food safety measures that are expected to be in place as per Chapter 3 are considered appropriate controls.
Documented traceability: Seafood processors
Seafood processors must meet the requirements of Standards 4.2.1 – Seafood. These requirements are all similar to Chapter 3 Food Safety Standards of the Food Standards Code and all food businesses should be meeting these as a minimum.
The only extra requirement of the Seafood system is Clause 11 – Seafood tracing:
A seafood business must maintain sufficient written records to identify the immediate supplier and immediate recipient of seafood for the purposes of ensuring the safety of the seafood.
Your local council Environmental Health Officer will inspect seafood traceability as part of the normal food safety inspection process.
Other seafood regulators
Fish export registered establishments
The Department of Agriculture, Water and Environment is responsible for regulating export establishments and the specific products for export. If bivalve molluscs are being processed or manufactured for the export market and the domestic market, SA Health will accept the audit findings of this agency.
Any domestic activities (for example, processing, manufacturing, retail) undertaken by the business that are not captured by the export registration will be regulated by SA Health or Local Government.
Contact SA Health or your local council Environmental Health Officer to confirm the requirements of your specific business activities.
Registered fish processors
A business that is registered as a fish processor by Primary Industries and Regions SA (PIRSA) -Fisheries and Aquaculture is captured under Fisheries Management Act 2007. PIRSA officers authorised under this legislation are not monitoring for compliance to Standard 4.2.1.
If your business is a registered fish processor that also conducts seafood or bivalve processing activities as defined in Standard 4.2.1, then a food safety inspection by local government or an audit by SA Health will be required.
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