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Title: Allergens: The European situation
Date: 25/09/2006
Autor: Kath Veal, International Regulatory Team Leader, L

Allergens: The European situation European allergen labelling legislation came into force on 25 November
2005 for twelve allergens and their derivatives, with certain exemptions.

Directive 2003/89/EC introduced a list of allergens, namely:
◆ Cereals containing gluten (i.e. wheat, rye, barley, oats, spelt, kamut or their hybridised strains)
◆ Crustaceans
◆ Eggs
◆ Fish
◆ Peanuts
◆ Soybeans
◆ Milk
◆ Nuts, i.e. Almond, Hazelnut, Walnut, Cashew, Pecan, Brazil Nut, Pistachio nut, Macadamia nut and Queenslandnut
◆ Celery
◆ Mustard
◆ Sesame seeds
◆ Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/litre expressed as SO2.

The Directive further set down comprehensive labelling requirements, even catching ingredients normally exempt from labelling, such as processing aids with no function in the final food.
Any allergenic ingredient used in the production of a foodstuff still present in the finished product, even in an altered form, or originating from an allergenic ingredient, must be indicated on the label with clear reference to the name of this ingredient. The reference may be in the name of the food, ingredients list or a separate statement. Take the example of a soya derivative, lecithin.
If the name of the food does not contain the word soya, a ‘contains/from soya’ declaration would be required.
Directives 2005/26/EC and 2005/26/EC set provisionally exempt derivatives of the allergens listed in 2003/89/EC, which do not require labelling as their processing removes all allergenicity. These are temporarily excluded until 25 November 2007, when the list will be finalised.
The adoption of provisional exemptions was later than planned and shorter than expected. The EC Standing Committee on the Food Chain and Animal Health accepted that industry may face difficulties meeting the November deadline for implementing new labelling for derivatives not included in the list.
Member State Authorities were advised, until 21 March 2006, to take this situation into account for nonexempted derivatives, notified to the Commission and the request for exemption denied, namely: peanut oil and fat; hydrolysed vegetable proteins from wheat or soya; lysozyme from egg used in cheese; and fish gelatine for uses other than a carrier for vitamins and flavours. Note should however be made that this extended deadline has now expired.

Why do we get so many queries about allergens?

Other parts of the world consider different foods as allergens
Many countries do not regard mustard and celery/celeriac as allergens but do include other foods, e.g. peas, kiwi and apple. This can cause problems for food companies, e.g. ensuring there is a common understanding of what
constitutes an allergen when sourcing ingredients/products. ‘May contain’ type statements are not specified in the legislation, which covers ingredients intentionally added to food, not those present from cross contamination. Authority opinions vary regarding advisory warnings and their wording and advise that they are no substitute for proper GMP and HACCP controls.
Blanket use of such ‘disclaimers’ may not contribute to due diligence and a thorough risk assessment should be undertaken for products with regard to undeclared allergens.
Detectable levels of undeclared allergens are likely to constitute a breach of food safety legislation as well as being a hazard to sensitive consumers.
Allergen boxes on labels are widely used, leading some people to believe they are compulsory. They are not required by law and clear ingredients labelling is sufficient to comply with the Directives. If allergen boxes are used to assist consumers they need careful checking. Several recalls have stemmed from allergen boxes not containing all allergens present even though they were declared in the ingredients list. Once you give consumers a shortcut they will rely on that information. Such a scenario could be considered an offence, e.g. misleading labelling, as well as a hazard.
The exemptions are specific, and many enquiries relate to fish gelatine. Yes, it must be labelled when used for any purpose other than as a carrier for vitamin or carotenoid preparations and flavours.
The future? We await action following the EFSA opinions on fructose, lupin and molluscs, and work on the derived products exemptions list. 
Best advice? Know your risks, know your allergens, understand them, and control them.

This article was reproduced with permission from Food & Beverage
International (copyright Haydon Jackson Publishing Ltd)
www.foodandbeverageinternational.com