We had so many questions during our allergen management webinar that our experts weren’t able to answer them all in the allowed time. While we answered each question by email, we wanted to provide everyone with our five favorite questions and answers.
If you missed the webinar, you can find the recording at this link.
Deb Smith, Vikan’s Global Hygiene Specialist; Dr Joe Baumert, Director of the Food Allergy Research & Resource Program (FARRP), and Dr Rachel Ward, Managing Scientist, Exponent were our experts for this presentation.
1. If the protein levels in the food I am handling are low, do I still need to validate my cleaning program as part of cross-contamination control? Do I also need a continual monitoring program related to allergen control?
Firstly, you need to understand the allergen profile and total protein content of all the ingredients/foodstuffs handled at your site. If total protein levels are low because the foodstuff is highly refined, then there is a lower risk of cross-contamination. Only if there is no protein present, for example in a highly refined vegetable oil, or the ingredient has been granted an allergen labelling exemption, would there be a consideration that there is no allergenicity risk.
Cleaning programs support overall food safety by protecting products from microbial and foreign body contamination as well as allergen cross-contact, and the capability of any cleaning regime should be validated to ensure it fulfills its intended purpose.
Ongoing monitoring should be performed to confirm that cleaning regimes and other cross-contamination prevention measures are being consistently performed to the required standard.
2. I would like to know your cleaning suggestions for pipes that are inaccessible to staff, for example, in the case where products with and without allergens pass through.
Pipework and vessels that are inaccessible for manual cleaning should, if possible, either be dismantled to allow access for cleaning or be cleaned using an automated process, e.g., CIP. In all cases, the cleaning procedure should be validated and verified to ensure that it works and is being applied correctly.
If it is not possible to develop a validated cleaning procedure, you have two options:
1) replace the equipment with new versions that are cleanable to the standard required,
or
2) use precautionary allergen labelling (PAL) on your products to indicate the unintentional presence of the allergens concerned. However, in this case you should still be able to demonstrate to an auditor or regulator that you have taken every possible action to reduce the level of contamination.
3. Which one is the best method to detect allergens in production lines?
There are many methods to detect allergens. Which one you choose will depend on the allergen you are trying to detect, the level you are trying to detect to, and why you are trying to detect it. The type of food or surface being sampled may also have an influence.
Common allergen detection methods
Rapid detection of general protein swabs
An area of surface is swabbed, the swab device is activated, and a reagent is released that changes colour to provide a qualitative and semi-quantitative result of the protein level on the surface: green means the surface is clean and purple means you need to re-clean. The more protein present, the quicker the color change to purple and the darker the color.
Pros: This is a quick, inexpensive and easy way to verify the cleanliness of surfaces by detecting protein residues left behind after cleaning.
Cons: This technique will detect all proteins on the surface, not just those associated with the allergen. Different versions are available with different sensitivities to protein, but none are as sensitive as the techniques below.
Rapid detection allergen-specific lateral flow test kits
Based on ELISA
Pros: It’s a quick and easy way to determine the presence of a specific allergen on surfaces after cleaning. An area of surface is swabbed; the swab is placed in an extraction solution to solubilise the allergen; and the solution is used alonside a test strip to provide a qualitative and semi-quantitative result of the allergen level on the surface (similar to a pregnancy or Covid test). It is cost-effective.
Cons: Not as sensitive as a lab-based ELISA or PCR. Kits not available for all allergens. May be some cross-reactivity (false positives).
Immunochemistry (ELISA)
Uses antibodies linked to enzymes to detect the allergen in solution. Antibodies and other molecules stick to a solid surface, and then an enzyme reaction causes a colour change that can be read by a machine.
Pros: Sensitive, allergen-specific, quantitative results, cost-effective
Cons: Variability in detection limits, cross-reactivity, and they are impacted to some degree by the effect of food processing on allergen detection
PCR
Extracts and amplifies DNA from a sample that contains a specific allergen.
Pros: Highly specific. Can be used on most processed foods. Can also be used to identify and quantify the allergen.
Cons: Results are qualitative and may not represent the amount of allergenic protein in a sample. Not usually recommended when an ELISA test is available.
Mass spectrometry
Method for detecting food allergens even in complex food matrices.
Pros: Can precisely identify and quantify allergens with high sensitivity and accuracy. Allergens are detected by their amino acid sequence, which helps avoid false positives. This can quantify multiple proteins in a single analysis.
Cons: Extracting proteins from complex food matrices can be challenging. The quality and efficiency of the extraction depends on the food's composition, consistency, and other factors. Different protocols may be required for different matrices.
Summary
ELISA Kits: Widely used but have limitations, especially with processed foods.
PCR Methods: Useful for specific allergens but not universally applicable.
Mass Spectrometry: Promising for allergen detection but needs further development for sensitivity and standardisation.
4. Could you speak to Supplier Guarantees? How can manufacturers determine whether their suppliers are doing an appropriate job of ensuring the ingredients are free of allergens?
‘Free from’ is a very challenging claim to make and requires extensive and strict controls of supply, handling, processing, and packing. The material needs to maintain its ‘free from’ status from its origin through all stages of handling, processing, and packing prior to reaching you.
Use suppliers certified to a GFSI-accredited standard, which includes allergen risk management. If possible, also inspect the specific site yourself.
Ask suppliers for more detailed declarations of the composition of the materials they supply:
- Statements per allergen – are they intentionally present, unintentionally present, or is there no risk of unintentional presence?
- Total protein content
- Declaration of all allergens present on-site
If it is a composite foodstuff, ask the supplier to share their suppliers’ statements per component of allergens intentionally present, unintentionally present, or no risk of unintentional presence.
Note: If any of these declarations make a ‘may contain’ statement related to the allergen to be declared ‘free from,’ then the ‘free from’ claim cannot be made.
You could ask your supplier for:
- allergen analytical testing for multiple batches of the material prior to choosing to take supply
- batch positive release testing per batch supplied.
You should insist that your supplier does not change supply to your site without a full change management review and approval, including allergen risk status, as this can significantly impact allergen profiles and ‘free from’ status.
There is not much else you can do, as your supplier is never fully in your control.
It is best practice to apply the principle of “Trust and Check!”
5. Gluten-free verification/certification under 20ppm is widespread, defined by government agencies, and expected from consumers. When do you expect this same trend for the rest of the top allergens?
Gluten-free is a claim with a defined compositional limit of <20ppm set by regulations in multiple markets. Compliance to this limit is usually generated using both lateral flow testing in production to confirm cleaning/segregation capability and ELISA tests on batches of finished product.
There is insufficient data to set quantitative limits for ‘free-from’ claims for other food allergens.
The proposed reference doses mentioned in the webinar can be used as food safety limits to determine when a precautionary warning label should be used as risk communication to allergy sufferers to avoid a specific food product. Levels above the reference dose would indicate that the food product contains the unintended presence of allergen at a level that may trigger adverse allergic reactions. There are no regulatory requirements yet to use such precautionary advisory labels in the USA or in many other markets, nor any quantitative limits that would define when they should be used.
The reference doses proposed are not limits to support ‘free from’ allergen claims.
Disclaimer: The responses given to these selected questions are the professional opinions of the industry experts involved and are not necessarily endorsements of any of the products and services mentioned. Companies should conduct their own site-specific risk assessments and develop their own hazard controls as part of their food safety plan.
For more information and support, please feel free to contact Deb Smith, Global Hygiene Specialist for Vikan, at dsmith@vikan.com.
