/ Annex 1 to FCP/INGR/118/15E-

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27 October 2015

Guidance document describing the food processes in which food enzymes are intended to be used

IMPORTANT DISCLAIMER

This guidance document has been produced by the Commission services after consultation with the Member States’ experts on food enzymes and the relevant stakeholders.

The descriptions of the food processesmay be useful for Member State control authorities and food industry to assure correct implementation of the food enzymes legislation.

They should be read in conjunction with the appropriate legislation, especially Regulation (EC) No 1332/2008 on food enzymes which constitutes the legal basis for the placing on the market and use of food enzymes in the EU

This Guidance document does not represent the official position of the Commission and is not intended to produce legally binding effects. Only the European Court of Justice has jurisdiction to give preliminary rulings concerning the validity and interpretation of acts of the institutions of the EU pursuant to Article 267 of the Treaty.

The Guidance notes have not been adopted on the basis of Article 9 of Regulation (EC) No 1332/2008.

Introduction

A large number of food enzyme applications have been submitted to the Commission on the basis of Article 17(2) of Regulation (EC) No 1332/2008 on food enzymes[1]. Most of the applications are used during processing or treatmentof food raw materials/ingredientsand only in few cases will be added to the final foods (e.g. lysozyme in cheese).

Article 7(c) of that Regulation lays down that the entry of a food enzyme shall specify the foods to which the food enzyme may be added.However, that Regulation does not explicitly refer to food processes.

Article 2 of Regulation (EC) No 178/2002 laying down the general principles and requirements of food law, establishing the European FoodSafety Authority and laying down procedures in matters of food safety[2] defines food as any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans.

Article 2 of Regulation (EC) No 852/2004 on the hygiene of foodstuffs[3] defines "processing" as any action that substantially alters the initialproduct, including heating, smoking, curing, maturing, drying,marinating, extraction, extrusion or a combination of thoseprocesses. It also defines "processed products’ as foodstuffs resulting from theprocessing of unprocessed products. These products may containingredients that are necessary for their manufacture or to give themspecific characteristics.

It is therefore, necessary to describe the different food processes in which food enzymes are intended to be used in order to facilitate the implementation and enforcement of the Union list of food enzymes.

In this context, food process may consist of the transformation of the raw material/ingredient where the food enzyme exerts its technological function. Therefore, the submitted application is most of the time described by " …(raw material) processing". A number of examples are given such as Grain processing, Starch processing, Protein processing, Egg processing, Yeast processing, Fruit and Vegetable processing, Dairy processing, Fat and Oils processing,…(where grain –cereals-, starch, proteins, eggs-egg yolk-, fruits, vegetables, dairy products, fats, oils,… are used as raw materials to be further processed).

The food enzyme can also be used to process a raw material which is directly used to produce (a variety of) well defined final foods. In this case:

-either the existing common terms for food processes may be used (Examples: baking, brewing)

-or the process may be named as "…(food/beverage) production" (Examples: cereal-based distilled alcoholic beverage production, wine production, flavouring production)

As indicated earlier, there are only few cases where the food enzyme is added to the final food to exert a technological function there. In that case, the application may be named by the final food/food category e.g. lysozyme: cheese.

The list of food processes are described in the Annex to this document.

Annex

Guidance document describing the food processes in which food enzymes are intended to be used
Baking processes
Baking processes rely on flour as the essential raw material and key source of enzyme substrate for the product. It leads to the production of foodstuffs such as bread, biscuits, cakes, pastries, `tortillas, baking specialties.
They are usually added during the mixing of the dough ingredients and act on the various substrates present in the flour, such as starch and other carbohydrates, fibers, lipids…
Different food enzymes may be used in baking processes for the following purposes: to facilitate the handling of the dough, improve its structure and behaviour during the baking step, ensure machinability and improve the production process, and improve the quality of the final bakery products, which might otherwise be impaired by the industrial processing of the dough.
Many food enzymes can be used in this process such as amylases, xylanases, lipases, glucose oxidases, peroxidases, glucoamylases, asparaginases, proteases.
Brewing processes and other cereal-based beverages
Brewing processes rely on cereals (malted or not) as the principal raw material and they lead to the production of beer and other cereal-based, alcoholic beverages.
The brewing process involves extracting and breaking down the carbohydrate and protein from malted barley and adjunct sources. That means that starch and other raw material components are transformed into dextrins and fermentable sugars, followed by yeast fermentation.
Enzymes are added e.g. during mashing or fermentation to increase or facilitate the production of fermentable sugars, facilitate the mash filtration, speed up the maturation process, and decrease the amount of carbohydrates in final products.
Food enzymes that can be used in these processes areamylases, xylanases, lipases, glucoamylases, betaglucanases, cellulases
Other Cereal-based processes
Cereal-based processes can cover the processing of products such as, but not limited to, pasta, noodles.
In the making of pasta food enzymes may be used to prevent the pigment loss during processing , to facilitate the handling of the dough, to reduce checking, to improve gluten strength in past dough and to accelerate the drying step thereby shortening the process time
In the making of noodles, food enzymes can be used to prevent the darkening of raw noodles or noodle dough sheets during production, to minimise speckiness (small dark spots), to make boiled noodles firmer, smoother and less sticky, and to make internal cross links between dough constituents.
Food enzymes that can be used in this process are amylases, xylanases, lipases, glucose oxidases, glucoamylases, asparaginases, proteases
Cereal based distilled alcohol beverages production
Cereal based distilled alcohol beverages process relies on cereal starch as the principal raw material.
They lead to the production of alcohol for spirits and other alcoholic beverages.
In the process of alcohol production, the starch contained in cereals is extracted and hydrolyzed by enzymes, followed by yeast fermentation. The ethanol is subsequently concentrated and recovered by distillation.
The enzymes are added to the liquefied mash either during starch hydrolyses or directly into the fermenter. They facilitate the degradation of cereals into fermentable sugars, improve the yield, and allow the use of higher process temperatures and lower pH, which reduces the risk of contamination during the fermentation step.
Food enzymes that can be used in this process are amylases, xylanases, glucoamylases, beta-glucanases, cellulases, polygalacturonases.
Coffee processing
Food enzymes may be added to the fermentation step to remove the mucilage coat from the coffee beans. The fermentation stage of coffee processing can be accelerated by the enzymatic treatment. It can also be used to reduce viscosity in coffee extracts, to Improve processing performance and to improve product stability. Food enzymes that can be used are pectin-lyase, beta-mannanase, polygalacturonase.
Dairy processing
Milk is the principal substance in dairy processing. Milk contains various components including proteins, lipids and lactose which are natural substrates for a number of different enzymes. Enzymes can be used in dairy processing for various purposes, such as clotting the milk by hydrolysing casein, hydrolysing the components into other substances which are themselves used as ingredients in a number of food products and hydrolyse lactose to produce lactose reduced dairy products.
Food enzymes that can be used in this process aremilk-clotting enzymes (e.g. chymosin, pepsin), lipases, beta-galactosidases (lactases), transglutaminase, lysozyme, lactoperoxidase
Egg processing
In egg processing enzymes can be used non-exhaustively to de-sugar the egg white thereby reducing unwanted browning (Maillard reaction) and associated off-flavour development during pasteurization and spray drying of eggs. In processing of egg yolks enzymes can be used to hydrolyse the phospholipids in the egg yolk giving better emulsifying properties and increased thermotolerance allowing higher pasteurization temperature of sauces and dressings containing enzyme modified egg yolk.
Food enzymes that can be used in this process are catalase, glucose oxidase, lipases, phospholipases.
Fats and oils processing
Enzymes used in fats and oils processing work on the ester bonds in these compounds and can be utilized in various processes such as in extracting vegetable oils in an aqueous process, in ester synthesis generating e.g. flavouring substances, in degumming (a physical refining process) and in enzymatic interesterification generating oils and fats with controlled melting characteristics without the formation of trans fatty acids. Lower processing temperatures, higher yield and better quality oils and fats are also typical benefits when using enzymes for fats and oils processing.
Food enzymes that can be used in this process are lipases, phospholipases.
Flavouring production
Enzymes can be used in the production of flavouring substances and flavouring preparations as defined in Regulation (EC) No 1334/2008. These may be then blended with other flavouring materials, permitted food additives and food ingredients to form compounded or formulated flavourings. A specific flavouring substance or preparation may be used in many of these different formulations providing simple or complex organoleptic properties e.g. strawberry, pear, chocolate, cheese, caramel, ripe banana, fresh mint, sweet, sour, acid, jammy, creamy, thick, green, etc. when added to the relevant foodstuffs.
a)Flavouring substances
The food enzyme functions as a biocatalyst facilitating the production of a chemically defined flavouring substance. An example would be the use of lipase to catalyse the reaction between an alcohol and an acid to produce an ester. Following the reaction the resulting ester is purified for example by filtration, heating and distillation.
b)Flavouring Preparation
The enzyme is used to convert substrates present in the starting material into other molecules with flavouring properties, the resultant extract being a flavouring preparation. An example would be the addition of beta glucosidase to tea leaves to hydrolyse the glucosides present in the leaves followed by distillation to produce a flavouring preparation.
Food enzymes that can be used in this process are alpha-amylase, polygalacturonase, lipases, alpha-glucosidase
Fruit and Vegetable processing
This process covers all processes which consist of transforming any fruit and vegetable raw materials. Non exhaustively, fruit and vegetables can be processed into juices, purees, compotes, jams, jellies and marmalades, canned fruits and vegetables, fruit and vegetables preparations, etc.
Typically, in Fruit and vegetable processing, enzymes such as cellulases, beta-glucanases, hemicellulases (xylanase) and pectinases are used to improve processing (solid-liquid separation, filtration, depectinisation and concentration, maintenance of texture and appearance).
Grain and starch processing
Grain processes might start with cereals (grains or grist) or flour as the raw material. Cereals, which are highly complex structures, are milled and processed in order to be fractioned into starch, gluten and fibers.
Enzyme systems act on the cereal components ensuring smooth and efficient processing and facilitating the separation (by opening the grain structure) and ensuring high purity/yield of the separated polysaccharide and gluten fractions.
The separated fractions are then further processed, notably the starch fraction which is either used as a food ingredient (e.g. in baking) or transformed enzymatically into ethanol or into glucose, maltose, high fructose and other syrups which are themselves used in a number of food products.
Food enzymes that can be used in this process are xylanases, amylases, amyloglucosidase, pullulanase
Protein processingincluding e.g. Meat and Fish Processing
Proteinprocesses rely on proteins (or protein containing raw materials) as the principal raw materials. Proteins or protein containing raw materials can be from different origins, e.g.:
-Vegetable (derived) raw materials, such as soy, wheat, maize, etc.
-Animal (derived) raw materials, such as milk and milk derived products (whey proteins, caseins), meat, fish, collagen, gelatine, etc.
Enzymes are used in protein processing to facilitate protein hydrolysis. The resultant product can be concentrated by centrifugation and sometimes followed by evaporation and drying to provide liquid or powdered protein hydrolysates, and then to be used in a wide range of foods (savoury foods e.g. soups, bouillons, dressings, snacks, meat derived processed foods, etc- or foods supplemented with protein –e.g. foods with particular nutritional purpose incl. infant formulae).
Food enzymes that can be used in this process are trypsin, chymotrypsin, leucylamynopeptidase, thrombin, transglutaminase, subtilisin.
Wine production
Wine making processes rely on grapes as the raw material and they lead to the production of wine.
Enzymes are used to improve the clarification and processing of wine (e.g. pectinases, glucanases), to release of varietal aromas from precursor compounds (glycosidase) and to reduce the formation of ethyl carbamate
Yeast extract production
Enzymes are used during the processing of yeast to produce products such as yeast autolysates, yeast extracts and yeast cell walls which are used by the food Industry for nutritive and flavouring purposes. The enzymes are already present in the yeast but not in a consistent amount, enzymes are therefore added to ensure a reproducible product. The enzymes are added at different stages in the process depending on the product to be produced, they hydrolyse biopolymers into smaller units such as free amino acids, sugars, nucleotides and manno proteins.
Food enzymes that can be used in this processleucyl aminopeptidase, phosphodiesterase, AMP deaminase, cellulases, alpha-amylases, subtilisin

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[1]OJ L 354, 31.12.2008, p. 7.

[2]OJ L 31, 1.2.2002, p. 1

[3]OJ L 139, 30.4.2004, p. 1