in the European Union
Directive 2000/13/EC, as amended by Directives 2003/89/EC and 2007/68/EC identifies 13 foods or food groups and sulphur dioxide (listed in Annex IIIa) that are found in a wide variety of processed foods which are considered to be important relevant triggers of allergic reactions. Ingredients which are exempted from allergen declaration are listed in Directive 2007/68/EC and include certain refined oils or polydextrins, which analytical and clinical studies have shown do not present a danger for allergic consumers.
in the United States Food
Allergen Labelling and Consumer Protection Act (FALCPA 2004) came into force on 1st January 2006. The Act mandates a shorter list of allergenic food groups, but requires indication of the species on the label in the case of fish, crustacean and tree nuts.
Precautionary Labelling
With the exemption of gluten (read more), so far, no commonly accepted triggering levels have been recognized in order to establish threshold for food allergens. The European Directive 2003/89/EC gives no threshold or guidance to what constitutes a safe level. However, in other countries there have been attempts to establish threshold values. The Swiss authorities - in close cooperation with leading allergologists – defined an action limit of one part per one thousand in 2001. This limit represented a compromise between the specific food safety needs of allergic individuals and industrial food production practices at that time. If unavoidable, contaminations of above 1 g per kg or litre must be declared as ingredients, whereas contaminations of below 1 g per kg or l may be declared (“Lebensmittelverordnung“ 2002, since 2005 “Lebensmittelkennzeichnungsverordnung“, LKV). The Australian Food and Grocery Council (AFGC) published an industry guideline in 2007 as guidance for allergen management. A three level grid was developed to assist in determining if the residual protein from allergenic substances through unavoidable cross contact presents such a risk that it requires a precautionary labelling statement. Three different action levels with thresholds for each food allergen were defined, derived from published data on the lowest triggering amounts measurable. The thresholds of the first level (no cross contact statement required) range from 2 mg/kg for egg, peanuts, sesame, tree nuts, crustacean to 5 mg/kg for milk and 10 mg/kg for soy as well as 20 mg/kg for fish and gluten. A further proposal might be a 10 mg/kg (as established in Japan) or 50 mg/kg limit as pragmatic practical approach. Obviously, the development of acceptable thresholds is an urgent challenge in the context of international harmonisation.
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