Allergen information raw materials

Careful and reliable compilation of allergen information is of great importance within the food industry to guarantee food safety. Careless management of data can lead to a product recall due to an incorrect label. This applies to allergenic ingredients, but also to the unintended presence (cross-contact) of allergens.

Allergenen Consultancy has developed a template with the aim of:

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allergen questionnaire
  1. to standardize and exchange allergen information in the chain
  2. a quantitative risk assessment of cross-contamination with allergens (eg VITAL) possible.

Standardization of the allergen information

Due to the disappearance of the so-called LeDa list as a basis for allergen information, there is a need for guidance. In practice, it appears that not only the LeDa list is used, but that many of the substances that were once on the ALBA list are still requested within the supply chain. This creates an unnecessary administrative burden.
More background on the need for uniformity in allergen information can be found in the November 2017 VMT news article 'LeDa list is being adjusted'.

Risk assessment of allergens

Within the food chain, allergen information is often indicated as +, -, or ? in product specifications or technical data sheets. A question mark indicates cross-contamination. This is insufficient. To calculate the risk of cross-contamination with allergens, not only information about the presence or absence of allergenic ingredients is needed, but also How much (quantitative).
When using the template, the relevant data is therefore requested in order to carry out a quantitative risk assessment.

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supplierIn practice, it appears that suppliers can have difficulty answering questions about the content of allergens or cross-contamination. Then it is not possible to carry out a quantitative risk assessment. However, not every cross-contamination in the raw material chain is a direct risk for the end product. With simple questions, which can often be answered, a better assessment of the risks is possible.
We have developed a guideline for this. A conversation can be initiated with the supplier based on the guideline 'Cross-contact in the supply chain and allergen risk assessment'. Download this document for free.

What information is mandatory?

A Precautionary Allergen Labeling (PAL) is a warning on consumer products. Such a warning is used if the risk assessment It appears that the amount of allergenic protein exceeds the safe limit. This takes into account the consumption size of the product. According to Regulation (EC) No. 1169/2011, this is voluntary information. The General Food Law Regulation also applies. It stipulates that products must be safe. To determine whether a food product is unsafe, the information available to consumers, such as on the label or through other sources, is considered, especially if it helps prevent health problems. Some countries use this clause to determine whether a product without PAL but with cross-contamination must be removed from the market. Despite the lack of clear European rules for the use of PAL, there are different countries with local regulations.

Information regarding allergen cross-contamination in the supply chain (B2B) is not a PAL. Cross-contamination in a raw material can pose a risk to the consumer, but this is not necessarily the case. If a raw material is used in a very low quantity in a consumer end product, any potential contamination may no longer be measurable or may remain below the safe limit. The risk assessment is therefore carried out by the manufacturer of consumer products. The raw material supplier provides information regarding the level of potential cross-contamination.
There is a legal obligation to transmit information on cross-contamination throughout the supply chain so that the end user can comply with (national) regulations. This therefore also applies to information on allergen cross-contamination. This information may be provided in various ways and is described in Article 8.8 of Regulation (EU) No 1169/2011. Also the Commission Notice and the Guidelines document provide more clarity on this.

The Dutch allergen policy also applies to B2B products and raw materials. A Product Listing (PAL) is not expected for these products, but information is required that enables the next link in the chain to comply with the obligation to provide a PAL if a risk exists. To perform a proper risk assessment, it is necessary to know the level of cross-contamination. This information is usually included in a product specification or an allergen table.

There are products that are sold both in the B2B channel and directly to the consumer. Consider bake-off rolls, for example. In that case, it may be necessary to indicate the level of cross-contamination in the product specification for B2B. For consumer products, the effect of cross-contamination can be calculated to determine whether a PAL is required or not. Both components can be indicated in the product specification.  

In the video below, Charlotte ter Haar from the industry organization explains Association for the Bakery and Confectionery Industry and Marjan van Ravenhorst from Allergenen Consultancy allergen regulations in Europe and the Netherlands. They specifically target raw material suppliers.

Explanation document

How do I get the allergen template?

The document is publicly available and can be downloaded for free The entered e-mail address is used for the newsletter so that the applicant can be actively informed of changes to the template.

What software is used for the document?

It is a fill-in form with fields, created in Word. This allows the user to simply check boxes and fill in the fields without having to change the formatting of the rest of the document. The fill-in form is secured (without a password). The form can be customized as desired, see under Customize.

What do the light gray texts mean?

These are explanatory texts. This is a tool to provide additional explanation about the information that must be entered in that field.
The light gray text disappears automatically once something is entered.

How is the document structured?

The template consists of the following parts: 

  1. Allergen list: detailed information per allergen from Regulation (EU) No. 1169/2011. This is divided into two main blocks: the red left block about allergenic ingredients and the green right block about cross-contamination in the chain. See also the images below.
  2. Additional Allergy Warning: Mandatory warning about allergic reactions to specific ingredients (usually Novel Foods).
  3. Allergen claims: information about free-from statements such as gluten-free. For example, products can contain wheat starch (check Yes for wheat in section 1 in the red left block) and still be gluten-free, if the legal limit of 20 ppm is met.
  4. Signature/approval. It is important that the information comes from the actual producer (see also document header). This does not always have to be the supplier, for example in the case of traders or agents.

What does "Exemption/allergen labelling not required" mean?

Some products are made from one of the fourteen allergenic substances, but are listed on the statutory list of exceptionsThey therefore do not have to be listed as an allergen on the label.

Change

Can the document be modified?

Yes, the questionnaire can be customized or converted into your own house style.
Open the document in Word. Go to the Menu option Review. Choose Protect and then Restrict Editing. Click on the Stop Protection button at the bottom right. The document can now be edited. For example, extra allergens can be added (if applicable for export outside the EU). Extra columns can also be added, if necessary.
When the document is ready, the document should be secured again so that it can be easily filled in. Select the Menu option Review, Protect and Restrict Editing again. Now click on Yes, start enforcing protection (3.). Do not enter any passwords, but only OK.

Can other allergens be added?

Yes, it is possible to expand the questionnaire with other relevant allergens. For example, for countries outside Europe, other legal allergens are important. For example, when exporting to some Asian countries, it is necessary to collect information about buckwheat as an allergen. Please note that the template is not supplemented with old ALBA allergens (such as coriander). This destroys the uniformity.
First consult with the requesting party whether information about these substances is really necessary or whether their list of allergens has not been updated.

To fill in

How do I determine protein % in the 'Used as an ingredient' column?

The protein content is usually found under nutritional value for single products. For compound ingredients, a list of ingredients can be found in the specification, but the protein content of the allergenic sub-ingredient is often missing.
This information is known to the supplier, from the raw material specifications of the sub-ingredients.
Example: for a composite product that contains milk powder, the producer can specify in the milk row: 10% milk powder with 35% protein or 3,5% milk protein.

What should I fill in for 'Homogeneous' and 'Particulate'?

This question is necessary to determine whether there is a homogeneous or inhomogeneous (point) contamination. In the case of a liquid, paste or powder, the allergenic ingredient will in many cases be homogeneously distributed in the raw material. Then the cross-contamination of the allergen in ppm (mg allergen protein/kg product) can be filled in in the column 'Homogeneous'.

In the event of contamination with one or more pieces or lumps (particulate matter, such as pieces of nuts, sesame seeds, cubes of cheese, lumps of dough, seeds, kernels, beans, etc.), the allergen concentration in the product can be very high locally. Such spot contamination can, depending on the allergen protein content of the piece, lead to an excess of the safe limit (action level). In that case, the weight and protein content of such a piece(s) must be entered in the "Particulate" column.

What is meant by PAL labelling remarks?

The buyer may not be familiar with a quantitative risk assessment (QRA). When cross-contamination is specified, some buyers assume that they have to adopt this and state it on their end products. Even if the contamination does not pose a risk to their products, for example because the raw material is used in a very low dosage (such as spices or aromas) or has a low contamination. The buyer does not know how to interpret the figures. To prevent incorrect conclusions being drawn and possibly every cross-contamination being stated on the end products, additional information can be provided in this column. The PAL labelling remarks column can include the advice for the use of a PAL by buyers.

Example of contamination of soy in wheat flour:
In the Homogeneous column, 50 ppm (mg/kg) is specified for the allergen soy. The PAL remarks column states: No PAL required if soy from our wheat flour is the only source of soy contamination. Consumption of 125 grams of wheat flour (high consumption as in bread) corresponds to an exposure of 6,25 mg of soy protein (50 ppm*0,125kg). This is below the safe level (ED05) for soy of 10 mg.

Use data in QRA/ VITAL

How do I use the data from a completed questionnaire in my QRA? VITAL calculation?

The data in the red left block is needed to calculate the cross-contamination of the own process in the QRA calculation. The protein content is used to determine the product with the highest share of protein per allergen as worst case. The total share of allergen protein in a product is the combination of the allergen protein content of the ingredient with the dosage/recipe. This data is entered in the Process tab in the Allergen Risk Calculator or in Processing Profiles in VITAL Online. There you need to fill in Allergen ingredient % and Protein %. Allergen ingredient % refers to the dosage of the ingredient. Protein % is the value from the column 'Used as an ingredient' of the questionnaire.

The data in the green right block are needed to calculate the cross-contamination in the product from the raw material. The maximum cross-contamination concentration in ppm is needed for homogeneous contamination (column 'Homogeneous'). For point contamination, the weight (in grams) and the protein content (%) of the allergenic contamination are needed. This is in the column 'Particulate'. This is entered in the Allergen Risk Calculator and VITAL Online at the raw material information.

View Risk Calculation Training
cross-contamination of allergens (VITAL)
Supplier allergen questionnaire left block Supplier allergen questionnaire right block

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allergen questionnaire