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    HEALTHY LIVING TNO initiates technological and social innovation for healthy living in a vital society.

    TNO Utrechtseweg 48 Postbus 360 3700 AJ Zeist the Netherlands

    Drs. Marcel van Zandvoort T +31 (0)88 86 61 816 E marcel.vanzandvoort@tno.nl



    ServiceS TNO caN Offer: Quantitative risk assessment of

    allergen cross-contamination, resulting in well defined action levels for allergen labelling

    Advice on labelling needs with expert statements

    Advice on improvement/adjustment of in-factory cleaning procedures

    Provision of chemical analyses, investigation of contamination patterns that also take into account peak and particle cross-contamination

    risk analysis on contamination hazard in:

    - Production chain - Ingredient sources - Manufacturing process at supplier

    MOre iNfOrMaTiON Are you concerned about allergens in your product and whether you should label ‘may contain’? Do you want to know more about basing your company’s risk management strategy for food allergens on evidence and the latest scientific data? for more information on a practi- cal, science-based approach to clarify allergen labelling and management in your company, please contact us. We will be glad to discuss the specific allergen challenge(s) and to advise on allergen management decisions.

    ScieNTific refereNceS Spanjersberg MQI et al., food and Chemical Toxicology, 2007, 45: 49-54.

    Kruizinga AG et al., food and Chemical Toxicology, 2008, 46: 1437-1443

    Madsen CB et al., food and Chemical Toxicology 2009, 47: 480-489

    Spanjersberg MQI et al., food Additives and Contaminants 2010 (27) 169-174.



    When should your food products be labelled for potential cross- contamination by allergens? TNO supports the development of evidence-based risk management guidance with quantitative action limits based on international approaches specifically adjusted for your company. This helps to deliver safe products.

    crOSS-cONTaMiNaTiON aND MaY-cONTaiN LaBeLLiNG Allergens in food are a risk for the allergic consumer. Traces due to cross- contamination of raw materials or production facilities with allergens may form a problem if they are unex- pected or incidental. Currently, no clear quantitative guidelines exist on how to deal with labelling the presence of allergens due to cross-contamination. Current EU regulations only contain a list of food allergens which have to be indicated on packaging whenever these, or ingredients derived from them, are used at any level in pre-packed foods.

    In terms of allergen management, a food manufacturer is faced with the main question of how to deal with potential cross-contamination of the end product with allergens and how to avoid labelling the product with a ‘may contain’ statement.

    Present legislation does not provide clear action levels to enable the manufacturer to assure acceptable levels. The manu- facturer clearly wants to avoid allergic reaction among its consumers and minimise consumer complaints.

    TNO has considerable consultancy experience in allergen management and has been working with international parties for years (for example Allergen Bureau Australia, ILsI Europe, may-con- tain working group in the Netherlands) to establish limits and develop international guidelines. furthermore, TNO developed an allergen risk assessment methodology to assess the risk of unexpected allergen exposure.

    PI&Q 12 - 4891 MEI 2012




    Currently the producer is responsible for deciding on the reference amount for consumption. Of course, this will lead to different action levels (ppm concentration of allergen) for different products, depending on the amount consumed. Therefore, the amount you select for your product is critical and must be scientifi- cally sound. TNO has the expertise to help you select the appropriate consump- tion figure for your product.

    If a company chooses to use VITAL, the risk management strategy for allergens will become more evidence-based and the risk management will include the latest scientific information regarding the sensitivity of allergic individuals. This will boost the confidence of allergic consumers in the consumer information contained on your products.

    HOW caN TNO SUPPOrT YOUr cOMPaNY’S aLLerGeN riSK MaNaGeMeNT STraTeGY USiNG THe UPGraDeD viTaL aPPrOacH? TNO offers a risk-based approach to support companies in their management of cross-contamination and the avoid- ance of labelling. Our approach combines your company’s knowledge of the production processes and TNO’s knowledge of food consumption, risk assessment and risk management of food allergens, resulting in an evidence- based allergen risk management strategy that ensures safe food products.

    Together, this helps the food industry in its decision to label products with a warning for the potential presence of food allergens, the precautionary ‘may contain’ labelling. Quantitative guidance (VITAL) developed by the Allergen Bureau in Australia was recently updated in cooperation with internationally recog- nized allergen experts from TNO and the American University of Nebraska’s food Allergy research and resource Program (fArrP), amongst others.

    viTaL GUiDaNce fOr crOSS- cONTaMiNaTiON aND PrecaUTiONarY LaBeLLiNG VITAL stands for Voluntary Incidental Trace Allergen Labelling and is a quantita- tive risk management system to support food producers in assessing the impact of allergen cross-contact and advising about allergen labelling. In 2007 the first VITAL publication contained tangible labelling advice for the unintended presence of allergens based on the concentration of the allergen in the food. In 2012, supported by international expertise, the Allergen Bureau (http:// www.allergenbureau.net/) revised the VITAL system.

    The revision in 2012 involved an updated science-based approach. relationships between the amount of allergen ingested and allergic reactions seen were modelled using advanced statistics. The outcome (table 1) indicates the reference dose (mg protein level as total protein from an allergenic food) to be used to define the action level of the concentration for deciding on the ‘may contain’ labelling.

    WHaT iS NeW iN THe reviSeD viTaL? The underlying scientific evidence was evaluated and rigorously updated with the latest information to set reference doses for ‘may contain’ labelling. furthermore, the action levels in the revised VITAL will have to be determined on a case-by-case basis using not only the reference dose

    (see table 1) but also the consumption of a specific product (reference amount). In 2007 VITAL included a table with action levels (ppm concentration of allergen) that advised labelling, which could be; no labelling, ‘may contain’ labelling or labelling as ingredient.

    Table 1: Reference dose of allergen for ‘may contain’ labelling *

    Allergen Mg protein level per eating occasion

    Peanut 0.2 Milk 0.1 Egg 0.03 Hazelnut 0.1 soy 1.0 Wheat 1.0 Cashew 2.0 (provisional) Mustard 0.05 Lupins 4.0 sesame 0.2 shrimp 10 Non-shrimp crustaceans & molluscs 0.1 1

    Celery No data fish 0.1 2

    Other treenuts 0.1 3

    1 Insufficient data, determined by VITAL 2 Insufficient data, based on VITAL 2007 level 3 Insufficient data, based on hazelnut


    Case-by-case interpretation is needed to derive product-specific action limits (ppm concentration of allergen protein)

    Vital reference

    dose (mg protein)

    Action limit


    Concentration in product

    > action limit

    Concentration in product

    < action limit

    No may contain label

    May contain label

    Measures to decrease


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