Food Improvement Agents

Food additives are substances used for a variety of reasons - such as preservation, coloring, sweetening, etc. - during the preparation of food.

Regulation (EC) 1333/2008 on food additives defines them as "any substance not normally consumed as a food in itself and not normally used as a characteristic ingredient of food, whether or not it has nutritive value, the intentional addition of which to food for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food results, or may be reasonably expected to result, in it or its by-products becoming directly or indirectly a component of such foods."

Food additives can be used for various purposes. The additives regulation defines 27 "technological purposes". Food additives are used, among other things, as:

• Colors – they are used to add or restore color in a food;
• Preservatives – these are added to prolong the shelf-life of foods by protecting them against micro-organisms;
• Antioxidants – they are substances, which prolong the shelf-life of foods by protecting them against oxidation (i.e. fat rancidity and color changes);
• Flour treatment agents – they are added to flour or to dough to improve its baking quality.

All authorized additives in the EU have followed a safety assessment. Additionally, food additives must also comply with specifications laid out in Regulation (EU) No 231/2012 containing the acceptable criteria of purity.

Regulation (EU) No 257/2010 set up a program for the re-evaluation of approved food additives in accordance with the additives regulation. The European Food Safety Authority (EFSA) is re-evaluating the safety of food additives that were approved before 20 January 2009 in order to consider latest available data.

Until June 2020, 124 scientific opinions have been published by EFSA on the re-evaluation of the safety of food additives covering 227 individual food additives. This includes data for food colors, preservatives, antioxidants, glutamates, silicon dioxide and aspartame. There are still 89 food additives (sweeteners and other additives) that need to be re-evaluated by EFSA before 31st December 2020.

EFSA assesses the safety of the food additives. The substances are evaluated based on a dossier, usually provided by an applicant (normally the producer or a potential user of the food additive). This dossier must contain the chemical identifications of the additive, its manufacturing process, methods of analyses and reaction and fate in food, the case of need, the proposed uses and toxicological data.

 The toxicological data must contain information on metabolism, sub-chronic and chronic toxicity, carcinogenicity; genotoxicity, reproduction and developmental toxicity and, if required, other studies.

Based on this data, EFSA determines the level below which the intake of the substance can be considered safe – the so-called Acceptable Daily Intake (ADI). At the same time, EFSA also estimates, based on the proposed uses in the different foodstuffs requested, whether this ADI can be exceeded. In case the ADI will not be exceeded, the use of the food additive is considered safe.

When EFSA estimates the possible exposure to a food additive, it considers the maximum level requested to be added in the different foodstuffs. In addition, EFSA assumes that the largest quantities of these foodstuffs are eaten on a daily basis. Only when this estimated exposure via the different foodstuffs remains below the ADI, EFSA will consider that the proposed use of the substances is safe. If the ADI is exceeded, the Commission can decide to restrict the use of the additive or not to authorize it at all.

The presence of food additives should therefore be considered safe even for consumers that eat large quantities of foodstuffs to which the additives have been used at the maximum permitted level.

A food additive may only be authorized if its use meets the following conditions:

• It does not, on the basis of the available scientific evidence, pose risks to the health of the consumer at the level of the proposed use;
• There is a reasonable technological need that cannot be achieved by other means; and
• Its use does not mislead and must have benefits for the consumer.

 When authorizing food additives other relevant factors may also be considered. These could include ethics, traditions, the environment, etc.

The additives regulation provides that food additives must have advantages and benefits for the consumer. Therefore, they have to serve one or more of the following purposes:

• Preserve the nutritional quality of the food;
• Provide necessary ingredients or constituents for foods manufactured for groups of consumers with special dietary needs;
• Enhance the quality or stability of a food or improving its organoleptic properties, provided that the consumer is not misled;
• Aid the manufacture, processing, preparation, treatment, packing, transport or storage of food, including food additives, food enzymes and food flavorings, provided that the food additive is not used to disguise faulty raw materials or cover up unhygienic practices.

The use of food colors must always comply with the general condition that they do not mislead the consumer. For example, the use of colors should not give the impression that it contains ingredients that have never been added.

Only food additives that are listed in Annex II and III of Regulation (EC) 1333/2008 can be added to food and this can be done only under specific conditions.

Additives causing minimal toxicological concerns may be added in almost all processed foodstuffs. Examples include calcium carbonate (E 170), lactic acid (E 270), citric acid (E 330), pectins (E 440), fatty acids (E 570) and nitrogen (E 941).

For other food additives the use is more restricted, for example:

• Natamycin (E 235) can only be used as preservative for the surface treatment of cheese and dried sausages;
• Erythorbic acid (E 315) can only be used as antioxidant in certain meat and fish products;
• Sodium ferrocyanide (E 535) can only be used as anti-caking agent in salt and its substitutes.

In some foodstuffs the use of additives is very limited. For unprocessed foodstuffs such as milk, fresh fruit and vegetables, fresh meat and water only a few additives are authorized. And in some cases, such as in honey, the use of additives is not permitted at all.

The more a foodstuff is processed, the more additives are authorized and used. Confectionary, savory snacks, flavored beverages and desserts are some products falling under this category of highly processed foodstuffs, where many additives are authorized for use.

The food additives that are authorized in foodstuffs and their conditions of use are listed Annex II of Regulation (EC) 1333/2008 on food additives, while Annex III lists those additives permitted for use in food additives, food enzymes and food flavorings. Only additives that are in those lists are authorized under specific conditions. The additives are listed on the basis of the categories of food to which they may be added.

 In addition, there is a database from the European Commission available online. Through this database the consumer or business operator can find out which additives are authorized in a particular food.

The authorization procedure for food additives is laid down in Regulation (EC) No 1331/2008. An additive is usually authorized following an application to the European Commission by an interested party. For new additives, the Commission will request EFSA to assess the safety of the substance. After EFSA has given its opinion (within 9 months following the request), the Commission, together with food additive experts of all Member States, will consider the possible authorization. The safety assessment, the technological need, the possibility for misuse and the advantages and benefits for the consumer are all taken into account.

If considered appropriate, the Commission will prepare a proposal for possible authorization of the additive and present it for vote at the Standing Committee on the Food Chain and Animal Health (SCoFCAH). If SCoFCAH supports the proposal it will be presented to the Council and the European Parliament. They can still reject it in case they consider that the authorization does not comply with the conditions of use set out in EU legislation.

Additives in foodstuffs are labelled according the rules set out in Regulation (EU) 1169/2011 on food information to consumers. Food additives are food ingredients and should be mentioned in the ingredients list. The additives must be designated by the name of their category followed by their specific name or E number. For instance: "colour (curcumin)" or "colour (E 100)".

The E number can be used in order to simplify the labelling of substances with sometimes complicated chemical names.

It is indeed possible to prepare food without the use of any additives. Additives are normally not added to food prepared at home. However, at home, food is usually consumed within a short space of time. In addition, home preparation may also have less influence on the appearance compared to industrially processed food.

 Not all industrially prepared foodstuffs need additives. Examples include certain types of bread, some kinds of packaged meals, certain breakfast cereals, etc. Whether additives are needed or not, depends on the production process, the ingredients used, the final appearance, the required preservation, the need to protect against possible development of harmful bacteria, the kind of packaging, etc.

 On the other hand, it is worth mentioning that many foodstuffs contain naturally occurring substances, which are at the same time authorized as food additives. For example, in apples one can find riboflavins (E 101), carotenes (E 160a), anthocyanins (E 163), acetic acid (E 260), ascorbic acid (E 300), citric acid (E 330), tartaric acid (E 334), succinic acid (E 363), glutamic acid (E 620) and L-cysteine (E 920).

Source: https://ec.europa.eu/commission/presscorner/detail/en/MEMO_11_783