Bivalve mollusc and seafood businesses food safety requirements
The Australia New Zealand Food Standards Code (the Code) contains standards to regulate food sold in Australia and New Zealand, including Chapter 4: Primary Production and Processing Standards.
Businesses required to comply
Standard 4.2.1 Primary Production & Processing Standard for Seafood sets out food safety and suitability requirements for seafood handling up to, but not including, manufacturing or retail activities.
Standard 4.2.1 has additional food safety requirements for bivalve mollusc primary producers, processors, manufacturers.
The Standard does not apply to the following:
- retail businesses, restaurants, food service or other food businesses that process bivalve molluscs for sale or direct consumption
- importer and/or wholesalers that only store and dispatch pre-packaged bivalve molluscs (for example, no other processing or manufacturing)
- retail businesses, restaurants, food service or other food businesses that process seafood for sale or direct consumption
- seafood manufacturers.
The Standard captures both primary production and food business activities
Primary producers that undertake primary production (grow, harvest, catch) or a combination of primary production and food business activities will be regulated by Biosecurity SA (Primary Industry and Resources SA).
Food Safety Management System
A Food Safety Management System 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 certain filter feeding bivalve molluscs, businesses involved in their primary production, processing and manufacture are required to implement a documented Food Safety Management System.
Your business's Food Safety Management System must be verified (audited) as per the assigned frequency, which will be between 3 to 12 months, based on the performance of the business.
Bivalve mollusc processors and manufacturers
These businesses must manage the higher risk of bivalve molluscs by implementing a documented Food Safety Management System (FSMS), and have it verified (audited) by SA Health.
A Food Safety Management System be one of the following:
- A Hazard Analysis and Critical Control Point (HACCP)-based FSMS recognised by SA Health*
- A Food Safety Program (FSP) set out in Standard 3.2.1 of the Code
- The Codex Alimentarius Hazard Analysis and Critical Control Point System; (HACCP) for food safety management - Annex C to CA/RCP 1-1969, revision 4 (2003)
- A Food Safety Management System set out in the Commonwealth Export Control (Fish and Fish Products) Orders
*The HACCP based FSMS can be provided as a template from SA Health, but it must be modified to suit your business.
Due to the lower risk presented by other seafood, these businesses do not need a Food Safety Management System, but must comply with:
- Traceability: the business must maintain sufficient written records to identify the immediate supplier and immediate recipient of the seafood (Standard 4.2.1)
- To control food safety hazards that could arise from the handling of seafood (Standards 3.2.2 and Standard 3.2.3)
Inspections will include a strong focus on traceability to ensure compliance with the requirements of Standard 4.2.1. In most cases Local Government will conduct the inspections, at a frequency of 3 to 18 months depending on compliance history of the business.
Frequently asked questions
- Do all seafood businesses need to comply with Standard 4.2.1?
- How do I know if I need to comply with Standard 4.2.1?
- How does my business comply with this Standard?
- How will SA Health help my business comply?
- What will happen at an audit and how often will my business be audited?
- What are the fees?
- What businesses do Biosecurity SA look after?
- Primary Industries and Regions SA (PIRSA) is already monitoring the business; does that mean SA Health or Local Government audits or inspections are not required?
- What about Export Accredited businesses?
- retail businesses, restaurants, food service or other food businesses that process (for example shuck) bivalve molluscs or process seafood for sale or direct consumption
- importer/wholesalers that only store and dispatch pre-packaged bivalve molluscs (as there is no other processing or manufacturing)
- seafood manufacturers.
A Local Government or SA Health officer may identify your business as being affected and will give you a Self-Assessment Tool. Complete this and return to SA Health's Food Safety and Nutrition Branch.
If you require assistance with completing the Self-Assessment Tool, or if you have any questions about how your business is affected, please contact SA Health's Food Safety and Nutrition Branch.
Food businesses are responsible for:
- implementing a suitable Food Safety Management System or documenting Traceability;
- ensuring appropriate records are kept to demonstrate compliance;
- contacting SA Health's Food Safety and Nutrition Branch to arrange compliance audits if you are required to implement a Food Safety Management System
- contacting your local Environmental Health Officer if you are required to document traceability.
SA Health has developed a Food Safety Management System template for food businesses that process or manufacture bivalve molluscs.
Additionally, SA Health will offer initial support to affected businesses on how to comply with the requirements.
Your auditor will assess your Food Safety Management System for adequacy at the first and subsequent audits. Businesses are responsible for any auditing costs that may be incurred.
The initial audit frequency may be 6 monthly. The outcomes of two audits will be required to establish a compliance history that can allow for the adjustment of audit frequency. The auditor may adjust frequency based on performance after this time in the range of 3 to 12 months. For example, where a business performs well, audits may be reduced to annually, however if a business performs poorly, audits may be more frequent.
Audits: Contact SA Health (Food Safety and Audit) for details.
Inspections: As per the individual Council.
The following businesses are regulated by Biosecurity SA (Primary Industries and Regions SA) under the Primary Produce (Food Safety Schemes) Act 2004:
- primary producers and primary producers that process seafood, including bivalve molluscs.
- seafood transporters that are also accredited meat transporters.
- primary producers that sell product to the public from their primary production premise.
Primary Industries and Regions SA (PIRSA) is already monitoring the business. Does that mean SA Health or Local Government audits or inspections are not required?
Not necessarily. PIRSA has different sections, and the section for Fisheries/ Aquaculture does not monitor food safety.
Please contact SA Health to confirm whether your business is undertaking activities that need to be audited or inspected under the Primary Produce (Food Safety Schemes) Act 2004 or the Food Act 2001.
The Department of Agriculture is responsible for regulating export facilities and the specific products accredited for export.
Any domestic activities (for example, processing, manufacturing, retail) undertaken by the business will be regulated by SA Health or Local Government.
Contact SA Health or Local Government to confirm the requirements of your specific business activities.
All aquatic vertebrates and aquatic invertebrates intended for human consumption, but excludes amphibians, mammals, reptiles, and aquatic plants.
Includes cockles, clams, mussels, oysters, pipis and scallops intended for human consumption, but excludes scallops and pearl oysters, where the only part of the product consumed is the adductor muscle, and spat.
These bivalve molluscs are a higher food safety risk because they are filter feeders and are eaten with viscera and other organs intact.
- killing, dismembering, filleting or cutting into portions, gill or gutting or skinning of seafood
- depuration of shellfish and crustaceans
- shucking or peeling of seafood
- cooking, including steaming or boiling, or crustaceans
- brining of seafood
- packing, treating, washing, freezing, refrigeration or storing of seafood
- other similar activities
Wholesaling and importing of seafood is captured as it involves processing.
Canning, smoking or crumbing of seafood or the addition of other food to seafood and other like activities.