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AMFEP allergen labelling statement

Introduction - About Enzymes:

Enzymes are essential biological molecules responsible for reactions that sustain life. Enzymes are proteins, whose role is to speed up chemical reactions that therefore play a vital role in all biological functions such as metabolism and digestion. In the absence of enzymatic reactions, most biochemical reactions are so slow that they would not occur under the mild conditions of temperature and pressure that can be found in nature. Enzymes accelerate the rates of such reactions by well over a million-fold, so reactions that would take years without the use of enzymes can occur in fractions of seconds if catalyzed by the appropriate enzyme.

Enzymes have always been inherently present in common foods such as fruits, vegetables, dairy, meat, fish, eggs and grains, and are thus consumed by humans and animals every day.

Do food enzymes pose an allergenic reaction by ingestion?

Allergy reactions to a particular food (e.g., peanuts) are rare. The incidence of allergy to specific foods, is relatively low (i.e., 1–3 % of adults and 4–6 % of children) compared to cases of food intolerances (e.g., lactose intolerance) and food poisonings.

Food enzymes have not been demonstrated to induce food allergic reactions.

Assessment of food allergy potential of enzymes

Industrially produced enzymes have played a vital role for many centuries in the manufacture of various foods and beverages (e.g., bread, beer, and dairy). Several studies have consistently concluded that there are no scientific indications that small amounts of enzymes in food can cause allergic reactions in consumers. Previously a published study on Consumer Allergy Risk from Enzyme Residues in Food performed an in-depth analysis of the allergenicity of enzyme products (Dauvrin T et al.(1998)).

Enzymes are typically used as processing aids, thus in very small amount during food processing and are generally not functional in the final food. Nevertheless, a systematic evaluation of the potential to cause food allergy is conducted for every new enzyme developed.

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The assessment is typically based on what is known about food allergens, including the history of exposure and safety of the gene source and the structure of the proteins (i.e., the amino acid sequence identity to known human allergens).

A bioinformatic analysis comparing the amino acid sequence of the enzyme to a database of known allergens [e.g., allergenonline; (] is conducted to determine whether the enzyme is a known allergen or potentially cross-reactive to a known allergen. Further, the World Health Organization and International Union of Immunological Societies (WHO/IUIS) Allergen Nomenclature Sub-committee website ( is evaluated to determine if the enzyme has been identified as a food allergen. Taken together, these data provide further evidence that there are no food allergy concerns with the use of enzymes in the manufacture of various foods or beverages.

EU regulatory environment

The EU has in place several regulations to ensure that food products and ingredients used in food are properly assessed for any potential allergenicity, and relevant guidelines on informing the consumers on their allergy risk.

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Assessment of enzyme allergenicity potential

Regulation (EC) 1331/2008 states that any new enzyme to be put on the EU market will need to be assessed and approved. Part of this risk assessment focuses on allergenicity and the EFSA Guidance for submission of dossiers (EFSA, 2009) recommends to apply the integrated stepwise case by case approach used in the safety evaluation of the newly expressed proteins in genetically modified plants (EFSA, 2006, FAO/WHO, 2001): considering allergenicity of the source and search for amino acid sequence and/or structural similarities between the expressed protein and known allergens (as already described above).

Allergen labelling

Regulation (EC) 1169/2011 on Food Information to Consumers requires all allergens to be labelled. This regulation lists the ingredients or substances with known allergenic potential. This list has been built based on the opinions of the EFSA Scientific Panel on Dietetic Products, Nutrition and Allergies relating to the evaluation of allergenic foods for labelling purposes (EFSA, 2004, EFSA 2014) which provides details about the main foods and food ingredients that cause allergic or intolerance reactions among EU consumers.

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The EU Commission services and the representatives of the Member States have drawn up Guidelines relating to the provision of information on substances or products causing allergies or intolerances as listed in Annex II of Regulation (EU) No 1169/2011 on the provision of food information to consumers

In addition, some Member States such as the UK, have offered supporting guidance for food businesses on how to interpret this legislation.

For enzyme preparations, the allergen labeling provisions also apply according to Regulation (EC) No 1332/2008 on food enzymes. AMFEP has developed a statement on labelling of substances capable of causing allergies or intolerances present in food enzyme preparations.

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Most food enzymes are placed on the market as food enzyme preparations - which also contain food additives or other food ingredients that are added after fermentation. Therefore, in order to have a full assessment of the potential allergy risk of a particular product, it is the responsibility of food business operators that supply to manufacturers of final foods, and of the latter, to ensure that sufficient information is provided on all the ingredients - to properly inform the consumer about any possible allergy risk in the final product.

AMFEP strives to communicate consistent allergy information worldwide and collaborates with other

enzyme associations such as the Enzyme Technical Association and the Japanese Enzyme Association.

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