In this document an evaluation of hygiene and rancidity of fish oil intended for human consumption was carried out until the point of the production chain for fish oil at which a product intended for human consumption is obtained as a bulk stored product. This does not include encapsulated or other consumer packages or the final product ready to be sold to the consumer.

Within the scope of this document, only oxidation products may represent a potential chemical hazard in refined fish oil intended for human consumption whilst stored in bulk.

The refined fish oil production process typically includes several steps such as repeated heating at high temperatures (at 90-95°C and even up to 180°C) as well as alkali/acid treatments and removal of the water phase, which reduce the biological food safety risk to negligible. Lipid oxidation in bulk stored fish oil can be prevented by cold storage in darkness, without exposure to oxygen and addition of antioxidants.

Based on the currently available information, no qualitative or quantitative risk assessment of hazards in relation to rancidity of fish oil intended for human consumption can be carried out. The criterion of 60 mg total volatile basic nitrogen (TVB-N)/100 g for whole fish is not based on scientific evidence. Sensory assessment is recommended for the evaluation of the freshness of raw material for fish oil production for human consumption.

At present, the methods to determine the peroxide and anisidine values are the most reliable chemical methods for rancidity measurements in bulk fish oils. The present knowledge does not allow setting and recommending of maximum acceptable peroxide and anisidine values for the large variety of refined fish oils.