The VITAL® Program is intended to support risk assessment based on objective facts and data, rather than to establish internal maximum limits, The philosophy is to ‘Avoid, Reduce and Eliminate’ allergens as far as practicably possible. Refer to VITAL Science and the VITAL 4.0 Summary and FAQ’s (page 8 section “What does this mean for businesses?”). The total concentration (ppm) of a readily dispersible cross contact allergen is not influenced by a change in the Eliciting Dose (ED).
For suppliers of bulk products:
The VITAL guide page 10 section “Ingredients intended for further processing” states for supply of bulk products:
- Noting the definition of a particulate in section 2.4 of the VITAL guide, provide information on any particulate cross contact allergens.
- State the total concentration (ppm) of any readily dispersible cross contact allergens.
Bulk product includes product intended for food service or further processing, where the Reference Amount is not relevant. It is not appropriate for a bulk product for the supplier to assume a reference amount because the product is not intended to be consumed in its current form. Reference amounts impact the calculation of Action Levels and should be established solely by the end user. This is because the end user possesses essential knowledge, including food category specifics, target market considerations and intended product use.
The concentration or the particulate information provided should be determined following thorough review of raw material information, ingredient formulation if applicable and processing knowledge. Testing can be used to verify estimated levels if appropriate.
The VITAL guide has definitions for what constitutes a particulate under the VITAL program and information on how to determine cross contact levels. We strongly recommend VITAL training if an organisation is unsure how to determine the appropriate information. A list of training providers can be found here.
Note: ePIF6 allows suppliers to provide allergen information in the correct format.
For receivers of bulk products:
Investigate whether cross contact allergens from supplied raw materials or ingredients can be avoided, reduced, or eliminated without adversely affecting product safety or quality. If elimination is not possible, work with your supplier to verify the total protein concentration from the allergen source, e.g. total protein from peanut.
Each organisation in the supply chain has an essential role to conduct thorough risk assessments and provide supporting information. When information seems misaligned with the risk assessment, the receiving organisation should discuss its accuracy and reliability with the supplier, to ensure well-informed decisions about material specifications and management. Documenting of the rationale and monitoring data can help support these actions. The Allergen Risk Review Website (ARRW) has information that may assist you in these efforts.
