3. Compositional Aspects

General Foods
Germany

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

N/A

3.2 Raw Material Requirements

N/A

3.3 Fortification

Regulation (EC) No 1925/2006 [1] provides for the health requirements for food enrichment and restoration it does not apply to foods that have specific rules that prohibit or regulate enrichment or restoration.

Definition: Enrichment: the addition of one or more essential nutrients, naturally or not contained in the food, with the aim of reinforcing its nutritional value or preventing or correcting nutritional deficiencies.

In this case, the food must have its conventional sales denomination plus one of the following expressions: 

1. "Enriched with Vitamin(s)"
2. "Fortified with Vitamin(s)"
3. "Vitaminized"
4. "Enriched with Mineral(s)
5. "Fortified with Mineral(s)"
6. "Enriched with Vitamin(s) and Mineral(s)"
7. "Fortified with Vitamin(s) and Mineral(s)"
8. "Enriched with ... (mention name of nutrients)" 
9. "Fortified with... (cite the name of nutrients)"

3.4 Other Permitted Ingredients

N/A

3.5 Permitted Additives

The list of authorized food additives is harmonized in the EU under Regulation (EC) No 1333/2008 [2]. It is a positive list listing their conditions of use (maximal level). Therefore only the additives listed in this Union list are authorized in food sold in the EU, and the ones not listed are not authorized to be used in food (e.g. E171). It also applies to imported food.

An official online database is available for easy search [3]. Food additives must comply with their individual specification defined in Regulation (EU) No 231/2012 [4].

The provisions of Regulation (EC) No. 1333/2008 apply directly in all EU Member States and take precedence over national regulations. However, national regulations are possible in certain areas. In Germany, further national requirements, such as the labeling of certain food additive classes for bulk goods, are regulated in the Food Additive Implementing Regulation (LMZDV) [5].

"Non-prepacked foodstuffs in accordance with § 2 number 3 that are not offered for self-service, and non-prepacked foodstuffs pursuant to § 2 numbers 1 and 2 may be sold by the person responsible pursuant to Article 8 paragraph 1 or paragraph 4 sentence 2 of Regulation (EU) No. 1169/2011 with the aim of supplying to final consumers, or mass caterers, or by the person responsible pursuant to Article 8(3) of Regulation (EU) No 1169/2011 only if the food additives used in their manufacture are labeled with the following information":

1. in the case of foods with colorants, by the indication "with colorant",
2. in the case of foods with food additives used for preservation, by the indication by the indication "with preservative" or "preserved",
3. in the case of foods with food additives used as antioxidants, by the indication "with antioxidant",
4. in the case of foods containing nitrate or nitrite-curing salt, the indications referred to in points 2 and 3 may be replaced by may be replaced by the following information:
   1. for foods with nitrite curing salt, by the indication 'with nitrite curing salt',
   2. for foods containing sodium or potassium nitrate, whether or not mixed, by the indication 'with nitrate'; and
   3. for foods with nitrite curing salt and sodium or potassium nitrate, whether or not mixed, by the words "with nitrite curing salt and nitrate"
5. in the case of foods with food additives that are used as flavor enhancers, by the indication "with flavor enhancer",
6. in the case of olives with ferrous gluconate (E 579) or ferrous lactate (E 585), by the indication "blackened",
7. in the case of fresh fruit and vegetables with food additives with the numbers E 445, E 471, E 473, E474, E 901 to E 905, and E 914, which are used for surface treatment, by the indication "waxed",
8. in the case of meat products with food additives numbers E 338 to E 341, E 343, and E 450 to E 452 by the indication "with phosphate",
9. in the case of foods with sweeteners, with the exception of table-top sweeteners, by the statement "with sweetener(s)",
10. in the case of table-top sweeteners, the words "based on ...", supplemented by the name of the sweetener(s) used sweeteners used,
11. in the case of foods containing aspartame (E 951) or aspartame-acesulfame salt (E 962) by the statement "contains a source of phenylalanine",
12. for foods with more than 10 percent added polyhydric alcohols of the numbers E 420, E 421, E 953, and E 965 to E 968 by the statement "may have a laxative effect if consumed in excess".

3.6 Permitted Flavors and Colors 

Regulation (EC) No 1334/2008 [6] lays down general requirements for the safe use of flavorings and provides definitions for different types of flavorings. Under this regulation, the EU Commission has established the Union List of Flavorings, it contains an EU list of flavoring substances which are authorized to be used in food. The food industry can only use flavoring substances that are on the EU list. It applies to imported food to the EU.

There is an EU-positive list of smoke flavorings and smoke flavoring substances [7]. Only the substances listed can be used in food sold in the EU.

It is worth mentioning that color substances are described and listed in Regulation (EC) No 1333/2008 and not in a separate regulation.

3.7 Permitted Processing Aids 

Processing aids are defined in Article 3.2 (b) of Regulation (EC) No 1333/2008 [2] on food additives as any substance which:

• is not consumed as a food by itself;
• is intentionally used in the processing of raw materials, foods, or their ingredients, to fulfill a certain technological purpose during treatment or processing; and
• may result in the unintentional but technically unavoidable presence in the final product of residues of the substance or its derivatives provided they do not present any health risk and do not have any technological effect on the final product;

However, processing aids, including filtration aids and release agents, are excluded from the scope of Commission Regulation 1333/2008 unless they are used as food additives.

There is no specific European legislation regarding processing aids except for extraction solvents and enzyme preparations.

3.8 Additional Notes 

Novel Food

Novel food is defined in Regulation (EU) 2015/2283 [8] 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. 

In general, foodstuffs can be placed on the market without prior authorization within the framework of food law regulations. Novel foods are an exception to this rule. They are subject to uniform EU-wide regulations in order to achieve a high level of protection of human health on the one hand and to enable the smooth functioning of the internal market on the other. Novel foods must therefore undergo a health assessment before they can be placed on the market. Following a pre-market authorization, Novel food ingredients are authorized to be used in food on the EU market but may be subject to specific conditions of use.

Commission Implementing Regulation (EU) 2017/247 [9] has established the Union's list of Authorized Novel Foods. It is a positive list containing all authorized novel foods that can be used as food ingredients for the European Union market.

The Novel Food Catalogue 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 [10]. 

GMO

Regulation (EC) No 1829/2003 [8,9] 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.

A list of authorized GMOs that can be used as ingredients in food sold in the EU is available [11].

Food enzyme

Regulation (EC) No 1332/2008 [12] 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.

Regulation (EC) No 1332/2008 on food enzymes and Regulation (EC) No 1333/2008 on food additives combines all previous regulations on technological additives. It applies directly to all member states of the European Union; it no longer needs to be transposed into national law [13]. 

3.9 References

1. Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02006R1925-20230622

2. Regulation (EC) No 1333/2008 on food additives
https://eur-lex.europa.eu/eli/reg/2008/1333/oj

3. Additive database

https://ec.europa.eu/food/food-feed-portal/screen/food-additives/search

4. Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives
https://eur-lex.europa.eu/eli/reg/2012/231/oj

5. Regulation on the implementation of Union provisions on food additives (Food Additive Implementation Regulation - LMZDV)

LMZDV.pdf (gesetze-im-internet.de)

6. Regulation 1334/2008 on flavourings

https://eur-lex.europa.eu/eli/reg/2008/1334/oj

7. Regulation (EU) No 1321/2013 on smoke flavourings 

https://eur-lex.europa.eu/eli/reg_impl/2013/1321/oj

8. Novel Food Catalogue

https://food.ec.europa.eu/safety/novel-food/novel-food-catalogue_en

9. Commission Implementing Regulation (EU) 2017/247

https://eur-lex.europa.eu/eli/reg_impl/2017/2470/oj

10. Directive 2009/32/EC on extraction solvents

https://eur-lex.europa.eu/eli/dir/2009/32/oj

11. List of authorized GMO that can be used as ingredients in food sold in EU

https://food.ec.europa.eu/plants/genetically-modified-organisms/gmo-register_en

12. Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No 258/9

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02008R1332-20121203

13. Legal regulations for the use of additives

BVL - Zulassung von Zusatzstoffen (bund.de)