Specification assessment

The first step is to determine which allergens are to be considered for the risk review. For foods sold in Australia and New Zealand (ANZ), the mandatory declaration requirements are set out in the Australia New Zealand Food Standards Code Standard 1.2.3. Foods sold into other countries most likely need to comply with different requirements, and business may opt for other additional requirements. Also consider the regulatory requirements of any allergen claims on the label.

Allergen regulatory requirements vary throughout the world, so ingredient suppliers may not consider the same foods to be allergens as that in ANZ. For example, the EU have allergen labelling exemptions for tree nut oils, which do not apply in ANZ. This means that a specification for an oil ingredient sourced from the EU may not include the tree nut source. Understanding the regulatory requirements of the jurisdiction of the material being imported into ANZ will help prevent allergens being missed.

Contact the supplier directly and request information about the raw material. The Australia Food and Grocery Council’s Product Information Form (AFGC PIF) provides an ideal specification format for capturing allergen information for materials. Seeking additional information can help build a more complete understanding of the ingredient.

Never use finished product labels as a specification. Ingredient lists and allergen declarations on the raw material packaging may have been adjusted to comply with labelling regulatory requirements and may not provide enough information for a risk review. Ask the supplier to complete an AFGC PIF if they do not have one on file.

Create a raw material specification library. Store the specification and supporting material in a central location and ensure the information is complete and current and includes the presence of allergens where relevant.

Ensure a process is in place to manage updated PIFs when provided by the supplier (or when changes occur).

Clarifying information received from a supplier can assist in gaining confidence in supplier’s allergen knowledge and handling. Suppliers can approach allergen management in various ways, so working closely with individual suppliers can assist in understanding their allergen management processes and the risks of inadvertent addition of allergens.

When reviewing the supplier information consider:

• what the supplier’s interpretation and level of understanding is of allergen regulation
• does the supplier have an allergen management plan?
• is there an approved supplier program which includes allergen management?

Also:

• query anything unusual or unexpected
• don’t assume everything is correct just because it is written in a PIF
• keep asking questions until you are satisfied with the response
• change supplier if you don’t have confidence – do not accept data gaps

Many raw material suppliers readily provide information about the allergen status of ingredients. However, there may be times where it is difficult to obtain a PIF or other documentation, or at times the information may be incomplete.

An ingredient supplier (regardless of whether they are local or international) must provide information that is necessary for the purchaser to comply with the allergen declaration requirements of the ANZ Food Standards Code (refer to Standards 1.2.1 and 1.2.3). It is recommended that a conversation is started with the supplier explaining mandatory allergen requirements for Australia and New Zealand, which is followed up with questions that prompt the supplier to provide the information needed.

It may be helpful to ask the supplier to focus on the allergen section of the PIF, or to provide the supplier with a similar questionnaire specifically about allergens in that ingredient. Example Ingredient Allergen Risk Review Questionnaire. If you are not satisfied with the information provided, source an alternative supplier.

It may be difficult to obtain concentrations of cross contact allergens from suppliers. Where cross contact data cannot be provided, other information, such as batch sizes and the specific source of allergen, can help to make an informed decision about the possible level of allergen cross contact in the product.

The first step to identifying allergens that are intentionally included as part of the ingredient’s formulation is to review the PIF and supporting material. This should be done by a person who has knowledge in food technology, and a good understanding of food composition and processing is helpful.

The PIF has a section that breaks down the ingredient’s formulation into individual components. Look at each component and identify which are:-

• allergens (see the table to Schedule 9-3 of the Australia New Zealand Food Standards Code)
• products of allergens (for example, butter is a product of milk)
• derived from allergenic sources (for example, yeast may be grown on barley)
• ingredients that might be an allergen but are described unclearly (for example, vegetable oil)
• containing sub-components which may be an allergen (for example, spice blends or flavourings)

Include the food additives and the processing aids in this review. Carefully consider any hidden or unexpected allergens. The Allergen Bureau’s Unexpected Allergens in Food document provides a list of ingredients that can be an allergen risk and a list of questions to consider.

Take note of anything that needs further review and compare this information with the allergen sections of the PIF. Use the supporting documents to fully understand which allergens are intentionally added. Look for inconsistencies in information, or any clues that will trigger follow up conversations with the supplier.

Cross contact allergens are a residue or other trace amount of an allergenic food that may be unintentionally incorporated into another food or in this case, into a raw material. Identifying and understanding the risk of cross contact allergens in raw materials should be done by a person who has knowledge in food technology.

Allergen cross contact may occur at any stage within the supply chain, for example agricultural co-mingling (such as due to crop rotation), storage, transportation, processing and packing of the ingredient. Some ingredients can be quite complex as they are processed or handled at more than one facility and each facility may have different allergen risks. A raw material supplier needs to have a thorough understanding of the likelihood of cross contact throughout the supply chain and to be able to communicate these risks in the PIF or supporting information. Confirm with the supplier whether the VITAL Program has been applied.

If a PIF states that an allergen is present on the same line as the raw material being reviewed: –

• confirm with the supplier what ‘present on the same line’ means to them (for example, the packaging line only, the entire manufacturing process etc.)
• seek information to determine the controls in place to prevent cross contact occurring, and evidence to support the controls are effective
• if cross contact is occurring, seek the concentration of cross contact allergenic protein

To perform a VITAL risk assessment, cross contact allergens must be quantified by their protein concentration expressed in parts per million (ppm). The allergen section in the PIF captures information that can be used for this assessment.  If cross contact is present in an ingredient, the ingredient supplier will need to determine the amount of total protein present in the cross contact allergen, then calculate the protein concentration of the cross contact allergen in the ingredient that is sold. This link quantifying total protein shows an example with calculations.

The total protein present in the cross contact allergen can be sourced from information provided by suppliers, nutrition information panels, total protein analysis, food composition tables or other relevant food literature.

If the supplier has satisfactorily shown that allergen cross contact is not present in the ingredient, there will be no protein concentrations required for this ingredient in the VITAL calculations.

When using the VITAL Program, it is important to identify whether the cross contact allergens are present in a particulate or readily dispersible form, as this impacts on the risk assessment process that calculates the quantity of the allergen to which an individual is exposed.

Readily Dispersible is a powder or liquid in homogenous form. Readily dispersible cross contact allergens are homogenously distributed in the final product.

Particulates are separate and distinct particles of material. In the VITAL Program, a particulate refers to an entity of food which either does not mix homogenously with the food; or may consist of, or are likely to aggregate into an entity which contains a level equal to or greater than the relevant Reference Dose.

Identifying whether an allergen is a particulate or is readily dispersible requires some consideration because:

• some materials may be in particulate form or may be readily dispersible
• sometimes materials may be both
• sometimes materials may change form
• the form of the material will impact on the behaviour of the cross contact allergen within a food
• the form of the material may affect how it is declared on a label

Whether an allergen is a particulate or is readily dispersible is decided by:

• how the cross contact allergen behaves in the final food, and
• if it behaves like a particulate, the amount of the allergenic protein within the particulate

Particulates and readily dispersible materials can change form. If a cross contact allergen initially is present as a particulate, but a process such as grinding takes place prior to the allergen being mixed throughout the batch, it could be considered to be a readily dispersible allergen. A cross contact allergen can enter the process as a readily dispersible allergen, but the processing causes it to become a particulate, it could be considered to be a particulate allergen. An example of this would be where residues of a previous product may become dried or clump and then drop into the following product without breaking up.

This Case Study shows how an assessment of a raw material identified allergens present in both readily dispersible and particulate form. Case Study – Pasta ingredient allergen status

Particulates and the VITAL Program. Allergenic protein that is within a particulate does not spread homogenously through the product – it is concentrated into a small part of the product and therefore can be ingested in a single serve and has the potential to cause an adverse reaction in a susceptible consumer. Therefore, one particulate is enough to potentially elicit an allergic reaction. Because of this, particulate cross contact allergens are automatically categorised as Action Level 2 within the VITAL Program and declaration is required in the precautionary allergen statement.