Allergen Control: Raw material allergen risk assessment
Traceability and raw material quality assurance are key components of any food safety system; in terms of allergens, they allow manufacturers to track ingredients and products that may have been subject to deliberate addition of allergens or unintentional allergen cross-contact. Raw material specifications and product information forms should be thoroughly assessed for the presence of allergens, paying attention to identifying ingredients derived from allergens and potential hidden allergens.
Suppliers typically furnish raw material specifications and supplementary details voluntarily. However, it’s essential to be aware that certain suppliers may lack technical expertise or have inadequate controls.
It is often necessary to ask ‘the question’: Why does this ingredient have a precautionary label statement for X allergen? Is it because allergen cross-contact cannot be avoided, or could enhanced allergen control eliminate the risk of cross-contact?
What information do I need in order to conduct a raw material allergen risk assessment?
A raw material risk assessment is a prerequisite before ingredient approval. From an allergen management point of view, the findings from this assessment significantly influence the information that must be disclosed on the final product label. It is important to gather information on the raw material and raw material supplier.
The raw material information should be reviewed to determine at least the following:
- Is the raw material (or any of its ingredients) an allergen?
- Does the raw material (or any of its ingredients) originate from an allergen source?
- Are additives in or processing aids used to produce the raw material derived from allergens?
- Does the raw material carry any allergen ‘free-from’ claims?
- If yes, is there substantiating evidence confirming the absence of the allergen?
The raw material supplier information should be reviewed to determine the supplier’s overall allergen management practices:
- Are any other allergens handled on-site?
- Is there a potential risk of allergen cross-contact associated with the ingredient, and if so, what form does it take and what is the concentration?
- How is allergen cross-contact prevented or controlled?
- What allergen control measures are employed?
- Are those allergen controls validated and verified?
Pro Tip: Different jurisdictions require the declaration of different allergens. To avoid overlooking allergen information, it’s essential to understand the regulatory specifications of both the jurisdiction where the raw materials originate and the one where the final product will be sold.
Consider hidden or unexpected allergens
Allergens can sometimes be hidden in the name of an ingredient (e.g. beta-galactosidase – does it contain milk?) or can unexpectedly be contaminated with an allergen (e.g. soy cross-contact in maize). It is imperative that raw materials are scrutinised before approval to ensure label compliance.
Where do I get this information?
A product information form (PIF) or similar documentation (such as a supplier information form) must be provided by the raw material supplier, regardless of whether they are a local or international supplier. Obtaining accurate and reliable allergen information can sometimes be challenging. In cases where information is incomplete or inaccurate, it becomes important to engage in follow-up queries with the supplier until a satisfactory level of confidence in both the ingredient and the provided information is attained.
The information gathered during this process will feed into the information displayed on the final product label.
The Regulations Relating to the Labelling and Advertising of Foodstuffs (R. 146/2010, as amended) state that if a product contains a common allergen as an inherent ingredient, it must be declared in the product’s ingredient list or after the word ‘Contains:’, close to the ingredient list.
If the product contains no common allergens but there is a risk of cross-contact, the producer must implement an allergen management programme, documenting the risk assessment, assessment method, and preventive measures.
To determine whether precautionary allergen labelling – the wording ‘may contain (allergen)’ – is required, a risk-assessment tool such as the VITAL® (Voluntary Incidental Trace Allergen Labelling) Program can be used.
Remind yourself of the requirements with our useful infographic:
South Africa: Allergen Labelling
The Regulations Relating to the Labelling and Advertising of Foodstuffs
(R. 146/2010, as amended):
Definition of ‘common allergen’:
‘Egg, cow’s milk, crustaceans and molluscs, fish, peanuts, soybeans, tree nuts and any significant cereals, as well as ingredients derived from these foodstuffs that has retained its allergenicity in the final product’
Allergens
43. Where a product or its packaging material contains any common allergen, its presence shall be indicated, as the case may be:
(1)(a) in parenthesis after the name of such ingredient in the list of ingredients, if it is not self evident from the name of the ingredient; and/or
(b) in close proximity to the ingredient list in a list or block with the words “Contains: (allergen(s))”.
(2) in the case of significant cereals, the name of the specific significant cereal species shall be specified in the name of the ingredient in the list of ingredients with the word “gluten” indicated in parenthesis.
Allergen cross contamination
45. If there is a risk for cross-contamination of a common allergen in a food processing facility:
(a) due diligence shall be exercised to prevent the occurrence of such contamination and an allergen control policy (ACP) shall be implemented in accordance with the guidelines; and
(b) in the case where precautionary labelling is utilised, this shall not be utilised to circumvent the implementation of GMPs and an effective allergen control policy (ACP); and
(c) in the case where precautionary labelling is utilised, the risk, the manner of assessing the risk, and the steps taken to avoid the risk of allergen cross-contamination, shall be documented.
Continuous Surveillance
The evaluation of raw material risks necessitates at least an annual review; it should be done more frequently if so determined by your food safety management schedule. Where applicable the evaluation of raw materials should include reliable allergen testing to verify compliance (FACTS Essential Allergen Testing Guide). Regular scrutiny ensures that your food safety protocols remain adaptive and effective, aligning with the ever-changing production environments of suppliers, particularly in international supply chains.
Pro Tip: Add food safety elements to supplier agreements. Require suppliers to inform you promptly of any alterations to the allergenic profile of supplied ingredients or modifications to their Allergen Control Plan (ACP).
The raw material allergen risk assessment process should provide you with a clear understanding of the allergen status of a raw material and its manufacturing process. After conducting this assessment, you should have confidence in the information shared by the supplier, know which allergens are intentionally present, and understand the form and concentration of potential cross-contact allergens.
To support you and your team in navigating the allergen management journey, we’ve crafted a comprehensive approach to allergen control. Assisting with conducting raw material risk assessments and setting up allergen testing schedules are some of the avenues through which we help clients to enhance and refine their allergen control plans. Feel free to reach out to us for a more in-depth discussion of the possibilities.
Other articles, resources and videos you may be interested in:
Allergen Declaration Exemptions
Agricultural allergen cross-contact – farm to fork
Meaningful allergen quantitative risk assessment
FACTS Allergen Testing Guide
Supplier Allergen Questionnaire Questions