Question and answer

This indicates the absence of the allergen. For example, because no allergen protein present, such as with sesame oil. It may also be that the target protein is absent. For example, with a casein ELISA test, products containing whey will not be detected. Whey contains milk proteins other than casein. In that case, a total milk test or a ß-lactoglobulin test is the right choice.

In some cases, the result may also be false negative due to:

• a disturbance due to the product composition, for example with acidic products (pH<4),
• fermentation (for example sweet soy sauce from soy) in which the proteins are affected to such an extent that they are less or no longer detectable,
• strong heating of the product, such as with deep-frying oil, which has been heated at high temperatures for a long time.

To ensure that a product does not interfere with the analysis and is measurable, we recommend performing a one-time test positive and negative control to be included in the analysis. This validation is intended to ensure that no false positive or negative results are obtained. This applies to both laboratory and rapid tests. 

This indicates the presence of the allergen. In some cases, the result can be a false positive due to disturbing influences from the product matrix (cross-reactions). The known cross-reactions are included at details per allergen.

To ensure that a product does not interfere with the analysis and is measurable, we recommend performing a one-time test positive and negative control to be included in the analysis. This validation is intended to ensure that no false positive or negative results are obtained.

Analyses are used for various purposes, such as checking raw materials, making free-from claims on finished products, verifying cleaning processes, or validating cleaning processes. The frequency of analyses depends on the purpose and the risks.
For validations we have a handy step-by-step plan developed.

Yes, there are rapid tests for lactose. These are available upon request. These tests are only suitable for surface/swabs. Because these tests also measure other sugars, but not proteins, we only offer these tests upon consultation. A milk test is usually more suitable.
Lactose is a milk sugar found in dairy products alongside milk proteins. In the case of milk contamination, both lactose and milk protein will be present. The lactose to milk protein ratio in milk is approximately 2:1,5. Although there is slightly more lactose in milk, the milk protein analysis is more accurate than a lactose analysis. Therefore, a milk protein analysis is preferred.

Only at lactose-free claims or in the case of contamination with dairy products with a different lactose/milk protein ratio, such as milk, whey permeate or lactose powder, it makes sense to perform a lactose analysis.

No, there is no rapid test or ELISA test for celery. The analysis of celery protein is complex. The protein composition of the leaf, tuber and stem varies greatly. There is not yet a universal test available that detects all proteins from the different parts of the plant.

It is possible to do a DNA test (PCR analysis) to identify celery.

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With a swab test, the amount of allergen per cm² determined (µg/cm²). This is a different unit than the legal standard for gluten-free products or VITAL action level (mg/kg).

That means analyses of surfaces NOT ALLOWED can be tested against product standards. It is not the same unit. This requires ELISA or PCR analysis of a product to obtain a number expressed in mg/kg. Surface analyses are used to determine the effectiveness of a cleaning.

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This means that the result is outside the measuring range of the analytical method. A value can be reported in a limited measuring range. If a value falls outside the measurement range, a value smaller (<) or larger (>) will be stated on the certificate of analysis. In that case, a dilution can be used so that the value falls within the range.

It is therefore important to indicate with an analysis request what quantity is expected in the product, so that the laboratory can immediately use the correct dilution.

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boundaries and units

This may not be a problem, depending on the time outside the refrigeration and the ambient temperature. We ship products in a special refrigerated box with cooling elements, which guarantees the temperature for one to two days. The shelf life can be negatively influenced by (temporarily) higher storage temperatures.
The advice is to keep the rapid tests cool (<7°C) as soon as possible and to consume them if necessary.  

Yes, the detection limits are not very different and often the same antibodies are used for the different tests.
However, a rapid test does not give a quantitative (numerical) result and for some products a better extraction of the allergen in the laboratory is possible.

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The result is no longer reliable after the reading time. Lines may develop but should not be considered as lines. Read the strip exactly after the prescribed time and, if necessary, take a photo or scan to record the result. When the test dries out, lines form or flow. 

A very high allergen concentration can cause a negative result in the two-line rapid test. This is called the hook effect. At concentrations above 1000 ppm (varies per test), the T-line disappears. In three-line tests, a special H (hook) or O (overload) line is added for this purpose. When this line disappears, the difference between a high concentration and a negative result is visible.
A 'pure' allergen must be diluted to be measured properly.

Example: Milk powder contains approximately 35% protein = 350.000 ppm milk protein. This means that 0,5 grams of milk powder must be diluted in 500 mL of water to achieve a concentration of approximately 350 ppm.

No, this does not need to be listed as an allergen ingredient. Dried onion and garlic, but also other products such as various types of cabbage, contain natural sulphur compounds. This is sometimes confused with added sulphur. In some analyses, these naturally occurring sulphur compounds can interfere and give a false positive result for sulphur. Choose a method that can distinguish between the presence of natural sulphur compounds and sulphur. For more information, see our news article about sulfite.

No, if milk ingredients are used, the name 'milk' must be stated. An additional mention of 'lactose' is not necessary, but may be included additionally. 
For products such as cheese and cream, the word 'milk' does not have to be used extra. The legislator assumes that every consumer knows that these products are made from milk.

Under European law (Regulation EU 1169/2011), candlenut is not considered a tree nut and therefore does not need to be highlighted as an allergen in a different font or format on the ingredients list on the label. Because some nut-allergic consumers also report a reaction to candlenut, we recommend listing this ingredient by its full name (including the word "nut"). This provides complete information so people can make their own choice.

Yes, peanut or peanut oil is not exempted as an allergen. Even though the oil contains very little protein, this ingredient must be highlighted as an allergen in the list of ingredients on the label (for example, in bold or capital letters). This is in contrast to soybean oil, for which a legal exception applies.

Gluten-containing grains contain not only gluten but also other proteins. People with celiac disease react to gluten. For them, it doesn't matter which grain the gluten comes from. But for people with a specific grain allergy, such as a wheat allergy, the distinction between grains is important. They can react to other proteins that are present in one grain but not in another.

If the specific grain type is not known, the PAL (Precautionary Allergen Labelling) may list all individual gluten-containing grains, or the generic designation “gluten-containing grains” can be chosen.
Example: “May contain gluten-containing grains”.
If one or more gluten-containing grains (such as wheat, rye, barley or oats) are already listed as an ingredient, the wording “May contain other gluten-containing grains” can be used.

Spelt is a variety of wheat. Therefore, simply mentioning "wheat" in the PAL (Precautionary Allergen Labeling) is sufficient. The use of the word "spelt" is optional and may be included in addition, but is not mandatory. The word "gluten" may also be added voluntarily, as long as it is not used as a replacement for the grain. Therefore:
✓… “May contain wheat”
✓… “May contain wheat (gluten)”
Not allowed: “May contain gluten”
Gluten isn't the allergen itself; the allergen is the grain itself (such as wheat, rye, barley, or oats). This labeling method ensures that both people with celiac disease and those with a specific grain allergy are correctly informed.

The principle is that the individual nuts are specifically named in a PAL. People with a nut allergy usually don't react to all nuts, but to some. In some cases, a general indication of "may contain nuts" or "may contain other nuts" may suffice. This is explained in the Q&A from the NVWA.

Since January 1, 2024, the legal Dutch reference doses based on ED05 have applied. This allows a quantitative risk assessment to be carried out, comparable to the VITAL-systematic. Also VITAL 4.1 now uses ED05 instead of ED01.
The new VWS reference doses are therefore equal for almost all allergens de VITAL reference doses.

The allergen reference doses from VWS, FASFC (2024 updated) and VITAL 4.1 are all based on the FAO/WHO recommendations (ED05). Because the FAO/WHO recommendation for several allergens (part 5) was published more than a year later than the first recommendation (part 2 in 2022), discrepancies have arisen. The FASFC and VWS have themselves filled in the missing reference doses for several legal allergens.

The action limits, also called action levels, depend on the reference dose and the consumption size. Therefore, there is no fixed concentration. The action levels vary per allergen and per product type. 
First the consumption size must be determined and then the action levels for a product or product group can be calculated. The following formula is used for this:

action level = reference dose allergen (mg) / consumption size (kg)

The reference doses are in the Dutch allergen policy captured.

Yes, a quantitative risk assessment can also be performed for business-to-business products. However, information about allergen cross-contamination in the supply chain (B2B) is not a PAL. Information about cross-contamination is often included in a product specification. The raw material supplier provides information about the potential level of cross-contamination. This allows the consumer product manufacturer to perform the risk assessment.

It is of course useful if every step in the chain works with a quantitative risk assessment. But this is not always the case, especially with foreign or smaller suppliers. The allergen information in the standard product specifications of suppliers is regularly incomplete. So always ask! This can be done by:

1. Use our template for one satisfaction survey to request the information in a structured way. Or create a checklist with points that a supplier's product specifications must meet and check each specification/technical sheet for correctness and completeness.
2. Ask additional questions if quantitative cross-contamination information cannot be provided. Think of:
• Which allergenic ingredients are processed exactly?
• What preventive measures are taken?
• How is the equipment cleaned during an allergen transition: dry or wet cleaning?

Cross-contamination via raw materials can be relevant, so always ask! Even if no cross-contamination risks have been specified.
In our training courses we provide even more tips to easily collect as much information as possible to carry out a quantitative risk assessment of the raw materials.

Yes, the effect on the concentration can also be calculated in the case of point contamination. A quantitative risk assessment can therefore be carried out for this purpose. Our calculation tool, Allergen Risk Calculator, is the only calculation tool with additional functionalities to easily calculate point contamination in raw materials or processes.

A PAL may only be used if a risk assessment indicates a risk exists. Therefore, a PAL cannot simply be used because "cross-contamination cannot be ruled out." Instead, there must be evidence that cross-contamination actually occurs.

This is possible with a validation of cleaning in the event of contamination in the own process. For validations, we have a handy step-by-step plan This can also be a visual assessment if visible product residues or allergens remain, for example, with sesame seeds. Weigh the amount of remaining product and document it with photos.

In addition, information about cross-contamination in the chain must be requested. Do not request a QRA or VITAL-calculation. Use a satisfaction survey.

Risk assessment involves comparing cross-contamination in a product with the safe limit. A positive swab alone is not sufficient to justify the use of a PAL.

Our experience shows that a structured calculation tool significantly reduces the risk of calculation errors. However, it's not a legal requirement. Some clients do request calculations in a specific format. Two validated tools are available:

1. Calculation tool Allergen Risk Calculator (Excel) from Allergenen Consultancy. This is provided for on-site advice and at the VITAL training and can be used free of charge for 6 months. It is then possible to take out an update service for a small fee. This Calculator can be used to carry out a risk assessment of cross-contamination of the fourteen legal allergens. In addition to the calculation and testing against the VWS action limits, a comparison with the FAVV, VITAL and FAO/WHO reference doses are made.

   For companies that have received the Calculator during previous training or advice, it is possible to take out an update service for a small fee. A new license will then be automatically sent every year, as well as new versions of this calculation tool.

2. VITAL Online from the Allergen Bureau.