News item from 20-12-2023

Dutch allergen policy adjusted and new reference doses

A new Dutch allergen policy will apply as of January 1, 2024. This policy has been established by the Ministry of Health, Welfare and Sport (VWS) and will come into effect no later than January 1, 2026. The Dutch policy is the result of intensive consultation between government, industry and patient organizations and is enthusiastically received by all these parties. It is an integrated approach to cross-contamination with allergens according to the latest scientific insights. The low Dutch reference doses from 2016 have been abolished following the publication of the new values.

Establishment of policy

In 2016, the Risk Assessment Bureau (BuRO) of the Dutch Food and Consumer Product Safety Authority (NVWA) published temporary reference doses for carrying out an allergen risk assessment. This was a departure from zero tolerance. As a result, not every detection of an allergen was automatically a risk and therefore a reason for a recall. However, these values were much lower than that of VITAL-system, which was already widely used at that time. But another and more important difference with VITAL was that, if the risk assessment revealed a risk, according to the NVWA, no warning for the possible and unintended presence of allergens could be used. Such a warning - also called Precautionary Allergen Labeling (PAL) - was regarded by the NVWA as a 'notification without legal status'. In recent years, products have been withdrawn from the market with a PAL on the label, but where the NVWA values were exceeded. This led to a lawsuit in 2022. Based on international developmentsand because patient organizations indicated that they did assign value to a PAL, the court ruled that the products could not be banned.

The starting point in establishing the new policy was that PAL should not be used too often, but only if there is real risk to the allergic consumer. The frequent use of a PAL has given the impression that it is used by manufacturers to 'cover themselves'. Patient organizations have emphasized that cautious use is necessary to maintain credibility. They have also indicated that cross-contact should not be included in the list of ingredients. Manufacturers sometimes saw no way to meet conflicting requirements and moved the PAL to the list of ingredients. In addition to the fact that it is not legally correct to mention allergens in the list of ingredients when they are not always present, this unnecessarily limits the food choice of allergic consumers. This also applies to vegetarians and vegans. As a rule, they accept cross-contact with animal ingredients, but not if these have been deliberately added, such as milk, egg, fish, crustaceans or molluscs.

New Dutch policy

At the request of the Ministry of Health, Welfare and Sport, BuRO has evaluated the 2016 reference values. The Ministry has also initiated discussions with stakeholders. The NVWA, the Federation of the Dutch Food Industry (FNLI), the Central Bureau for Food Trade (CBL) and the patient and consumer organizations Food Allergy Foundation, Dutch Celiac Association, ProVeg Netherlands and Dutch Anaphylaxis Network (in memoriam Frans Timmermans) were present at these discussions. BuRO's advice from 2022 and these discussions have led to the adoption of the new policy. This policy has now been ratified by the Minister and will be laid down in a policy rule. The policy sets out the reference doses, status and wording of PAL. In addition, the food industry has been asked to draw up a more extensive document with guidelines for cross-contamination with allergens. This was done in consultation with the NVWA.

Content Policy

The policy document focuses on pre-packaged foods. Non-prepackaged products such as those sold in the catering industry, markets and craft businesses are not included. The new policy consists of three points:

Reference doses
The new reference doses (RfD) are based on the recommended values by FAO/WHO (ED05). This choice is supported by patient organizations. It is also expected that these values will be harmonized at international level in the near future via Codex Alimentarius. Codex Alimentarius has an important role to play in international harmonization of legislation. Codex has one FAO/WHO expert group on priority allergens, reference doses and application of PAL. Neighboring country Belgium has also already opted for ED05. The old and new reference doses are included in the table below.

Allergen	Advice BuRO NVWA 2016	VWS 2024
1. Nuts (cashew, almond, walnut, pecan, pistachio, Brazil nuts, macadamia nuts)	1,4 (cashew)	1,0
2. Hazelnut	0,011	3,0
3. Celery	-	1,0
4. Egg	0,0043	2,0
5. Fish	-	5,0
6. Peanut	0,015	2,0
7. Lupine	0,83	15,0
8. Milk	0,016	2,0
9. Mustard	0,022	0,40
10. Sesame	0,1	2,0
11. Crustaceans	3,7	200,0
12. Soybeans	0,078	10,0
13. Cereals containing gluten/Wheat	0,14	5,0 with a maximum action limit of 20 mg gluten/kg *
14. Molluscs	-	20,0

PLEASE NOTE: an RfD is not a concentration. The reference dose is an absolute amount of protein of an allergen (mg). To convert it to concentration (mg protein of an allergen / kg of product = ppm), the RfD must be divided by the consumption size (in kilos per eating moment).

* Within the group of gluten-containing grains, the FAO/WHO Expert Group has only established a RfD for wheat, although rye and barley have also been designated as priority allergens. It has been decided to maintain the RfD for wheat for all legal cereals. When converting the RfD to an action limit, the consumption size must be used. The calculated and therefore consumption size-dependent concentration is the safe limit for people with an allergy. In addition, a fixed legal limit of 20 ppm gluten for safe products (gluten-free) for people with celiac disease. Since these limits differ, it was decided to keep the lowest. This means that up to a consumption size of 250 grams the action limit is capped at 20 ppm, with higher consumption the lower action limit based on the RfD applies.

When the BuRO advice was published in 2022, FAO/WHO had not yet established RfDs for the non-priority allergens, including mustard, celery, soy and lupine. A number of members of the FAO/WHO expert group have provided personal advice on these allergens. This advice has been used to determine the other legal allergens, except for mustard.

Use of RfD and wording PAL
A legal value is now attributed to the use of a PAL. In the event of unavoidable, unintentional cross-contamination, the reference dose will be used as a testing instrument. In the event of a risk, a PAL is mandatory. But if no risk has been identified, PAL should not be used. The risk must also be demonstrable. Use of a PAL because "it cannot be ruled out" or "just to be sure" is not permitted. There is therefore a reverse burden of proof to prevent a PAL from being overused.
The wording that may be used for a PAL is “May contain xxx” or “Not suitable for xxx”. These are strict terms. Discussions are taking place as to whether "May contain: xxx" is allowed. By prescribing mandatory wording, it means that other wording such as “May contain traces of xxx” or “Made in a company that also processes xxx” are not permitted.
The patient organizations have expressed their preference for “May contain”. They believe that individual consumers should be able to make their own risk assessment as to whether a chance of presence is acceptable to them. They find “Not suitable for xxx” too restrictive. Contamination above the reference dose does not mean that the product is unsuitable for everyone with that allergy.
Guidelines for cross-contamination of allergens
The document 'Guidelines for cross-contamination of allergens' has been drawn up by the industry (FNLI and CBL) in consultation with the NVWA.
The document describes ten core elements in four chapters, namely raw material information, separation, cleaning and validation, risk assessment and risk communication.
The document emphasizes that prevention of cross-contamination is the starting point. It is also indicated that use of a PAL is not a reason to abandon preventive measures. Measures to prevent contamination are described, such as separation in time or place, cleaning, but also selection of suppliers, adjustment of recipes (repellent of allergens/product development) or technical adjustment of equipment or layout of the production location.
Much attention is paid in the document to the way in which a risk assessment should be carried out and the validation of the cleaning. Allergen analyzes can be used for this, but other methods are also described. Proof that cross-contamination actually occurs is an important part of the basic criteria for the use of a PAL.

Legal status and implementation

The Minister of Health, Welfare and Sport ratified the policy in mid-December 2023. It will be published as a policy soon. The policy rule will also be notified in Brussels. This is important in connection with the principle of mutual recognition, under which products that have been lawfully marketed in another Member State cannot simply be banned by another Member State. The new policy can be applied as of January 1, 2024. Companies have two years to implement this policy. The policy will apply from January 1, 2026. Further information will be posted on the NVWA website. The Labelling Manual of the NVWA needs to be amended accordingly. Patient organizations and the Nutrition Center will play an important role in explaining and communicating to consumers.

Actions and follow-up

Companies will have to assess their preventive measures and tighten them where necessary to prevent or at least reduce cross-contact. In addition, data will have to be collected to enable a risk assessment. For companies that already apply VITAL, a renewed risk assessment is necessary. The Allergen Risk Calculator from Allergenen Consultancy is equipped with several sets of RfDs. The calculation can therefore easily be tested against the new Dutch values. All sets are included in the new version, which will be released soon. For VITAL the RfDs based on ED01 remain in force for the time being, the values of the Netherlands, Belgium (2022) and those of FAO/WHO have been added.

It is expected that - a.o. by increasing the reference doses, it will often turns out that a PAL is not necessary. This warning will then have to be removed from the label. Labels must be adjusted from production date 1-1-2026.

The new Dutch policy and guidelines document is a big step. It is hoped that Dutch policy will set an example and ensure harmonization. At least until Codex Alimentarius has published the Guidelines on the use of PAL, after which the European Commission can adopt legislation for dealing with cross-contamination with allergens. But this process is expected to take quite some time.

A more extensive article with more background information will appear in the magazineAAR&WET 2024/1.

Sources:

Allergen policy VWS 2024 and reference doses
https://business.gov.nl/regulation/labelling-food/#art:information-on-allergens-on-labels
Advice from BuRO NVWA on reference values for allergens 2022: https://www.nvwa.nl/documenten/consument/eten-drinken-roken/allergenen/risicobeoordelingen/advies-van-buro-over-referentiewaarden-voor-allergenen-in-voedingsmiddelen
Lawsuit PAL 2022: https://uitspraken.rechtspraak.nl/#!/details?id=ECLI:NL:RBROT:2022:5609
Questions European Parliament PAL November 2023: https://www.europarl.europa.eu/doceo/document/E-9-2023-002994-ASW_EN.pdf