3. Compositional Aspects

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3. Compositional Aspects

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General Foods
EU

This section provides the compositional requirements for the food category and/or food products in scope and information on permitted nutrients, ingredients, and additives.

3.1 Composition Requirements

Article 2 of Regulation (EC) No 178/2002 [1] defines food or foodstuff as any substance or product, whether processed, partially processed, or unprocessed, intended to be, or reasonably expected to be ingested by humans.

3.2 Raw Material Requirements

Some ingredients are covered by individual product standards. When used as raw material, they need to be compliant with individual product standards, in particular milk and dairy products (e.g. butter and milk) [2].

3.3 Fortification

Food fortification is the process of adding essential vitamins, minerals, and other nutrients to food products to improve their nutritional value. In the European Union (EU), food fortification is regulated by Regulation (EC) No. 1925/2006 [3] on adding vitamins and minerals and certain other substances to foods.

The regulation sets out the conditions for adding vitamins, minerals, and other substances to food products, including the types of foods that can be fortified, the permitted forms and levels of fortification, and the labeling and advertising requirements for fortified foods.
Under the regulation, food fortification must be safe and beneficial and not mislead consumers. The European Food Safety Authority (EFSA) is responsible for assessing the safety and efficacy of food fortification ingredients and providing scientific advice to the European Commission.
The regulation states that only natural vitamins and minerals consumed as part of a healthy diet and regarded as essential nutrients should be permitted to be added to food. However, this does not necessarily imply that their addition is required.
The regulation also sets maximum levels for specific vitamins and minerals in fortified foods to prevent excessive intake, which can harm health. These maximum levels are based on the EFSA’s scientific opinions and are regularly reviewed and updated as necessary.
The European regulation aims to ensure the safety and quality of fortified foods and to provide consumers with accurate and valuable information about their nutritional content.

3.4 Other Permitted Ingredients

All ingredients generally consumed as foods, that are safe and suitable, are permitted to be used.

3.5 Permitted Additives

Food additives are substances added to food to preserve flavor or enhance taste, appearance, or other sensory qualities. In the EU, all food additives are identified by an E number. All additives in the EU must be authorized and listed with conditions of use in the EU's positive list [4] based on:

A safety assessment
The technological need
Ensuring that the use of the additive will not mislead consumers

Regulation EC 1333/2008 [5] sets the rules on food additives, definitions, conditions of use, labeling, and procedures. It contains:

Annex 1: Technological functions of food additives
Annex 11: Union list of food additives approved for the use in food additives and conditions of use
Annex 111: Union list of food additives approved for use in food additives, food enzymes, and food flavorings, and their conditions of use
Annex IV: Traditional foods for which certain EU countries may continue to prohibit the use of certain categories of food additives
Annex V: Additives labeling information for certain food colors

Food additives must comply with their individual specification defined in Regulation (EU) No 231/2012 [16].

3.6 Permitted Flavors and Colors
Flavors

Regulation (EC) No 1334/2008 [6] is specific to flavorings and certain food ingredients with flavoring properties in the European Union (EU). It provides a framework for the use of flavorings in various food categories and the definitions for different types of flavorings. The Regulation sets out substances for which an evaluation and approval is required or not. Annex 1 of regulation 1334/2008 with regulation EU 872/2012 [7] is the union list of flavorings. It contains the list of flavoring substances which are authorized to be used in food following approval.

In addition, there is an EU-positive list of smoke flavorings and smoke flavoring substances. Only the substances listed can be used in food sold in the EU [8].

According to Annex 111, Part B of the Regulation (EC) No 1334/2008 [6], maximum levels of certain substances naturally present in flavorings and food ingredients with flavoring properties, in certain compound food as consumed to which flavorings and/or food ingredients with flavoring properties have been added for processed vegetables as follows:

Name of substance

Compound food in which the presence of the substance is restricted

Maximum level mg/kg

1-Allyl-4-methoxybenzene, Estragol

Processed vegetables

The maximum levels shall not apply where a compound food contains no added flavorings and the only food ingredients with flavoring properties that have been added are fresh, dried, or frozen herbs and spices. After consultation with the Member States and the Authority, based on data made available by the Member States and on the newest scientific information, and taking into account the use of herbs and spices and natural flavoring preparations, the Commission, if appropriate, proposes amendments to this derogation.

Colors

Colors are classified as food additives covered by Regulation EC 1333/2008 [5] (see Section 3.5 above).

3.7 Permitted Processing Aids

Processing aids, including filtration aids and release agents, defined in Article 3.2 (b), are excluded from the scope of Commission Regulation 1333/2008. There is no EU legislation on processing aids nor is there any legally defined list of approved processing aids at the EU level. Some Member States laid down a positive list for processing aids.

While processing aids are not considered food additives, they are subject to regulation to ensure food safety and consumer protection. Processing aids are substances used during the manufacturing or processing of food products but are not intended to have any technological function in the final product. They are typically removed during processing and are not expected to be present in the finished food product in detectable amounts. Unlike food additives, processing aids are not required to be labeled on the final food product because they are not expected to remain in the product in detectable amounts. However, food business operators must keep records of the processing aids used in the production process for inspection purposes.

3.8 Additional Notes

Novel Food

Novel food is defined in Regulation (EU) 2015/2283 [9] as food that had not been consumed to a significant degree by humans in the EU before 15 May 1997, when the first Regulation on novel food came into force. Following a pre-market authorization, Novel food ingredients are authorized to be used in food in the EU market but may be subject to specific conditions of use.

The Commission Implementing Regulation (EU) 2017/247 [10] has established the Union list of authorized novel foods, it is a positive list containing all authorized novel foods which can be used as food ingredients for the European Union market.

The Novel Food Catalogue [15] lists products of animal and plant origin and other substances subject to the Novel Food Regulation. It is a non-exhaustive list and serves as an orientation on whether a product will need authorization under the Novel Food Regulation. EU countries may restrict the marketing of a product through specific legislation.

Extraction solvent

There is a positive list of extraction solvents authorized in food describing their conditions of use and maximum residue limits in the extracted foodstuff or food ingredient [14].

GMO

Regulation (EC) No 1829/2003 [11] defines the rules for genetically modified food and feed in the EU. Only the EU-authorized GMOs in food can be used as food ingredients for food sold on the EU market.

The EU list of authorized GMOs that can be used as ingredients in food is available [12].

Food enzyme

Regulation (EC) No 1332/2008 [13] on food enzymes lays down rules for placing on the market and using food enzymes in the EU. Only food enzymes approved in the EU may be sold as such, and/or may be used to produce food that is sold in the EU. This also includes food enzymes used to produce food and food ingredients (including flavorings) outside of the EU, and subsequently imported into the EU. The Union list of enzymes authorized in food is under development.

3.9 References

1. Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety

https://eur-lex.europa.eu/eli/reg/2002/178/oj

2. Regulation (EU) No 1308/2013 establishing a common organization of the markets in agricultural products

https://eur-lex.europa.eu/eli/reg/2013/1308/oj

3. The addition of vitamins and minerals and of certain other substances to foods Regulation (EC) No. 1925/2006

Regulation - 1925/2006 - EN - EUR-Lex (europa.eu)

4. Positive List of additives – Database

Food and Feed Information Portal Database | FIP (europa.eu)

5. Regulation EC 1333/2008on Food Additives

Regulation - 1333/2008 - EN - additives - EUR-Lex (europa.eu)

6. Flavourings in food Regulation (EC) No 1334/2008

Regulation - 1334/2008 - EN - EUR-Lex (europa.eu)

7. Implementing Regulation 872/2012 adopting the list of flavouring substances