3. Compositional Aspects

General Foods
Spain

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

For foodstuffs in general, various community and local provisions of a horizontal nature are applicable, which affect certain aspects regulated by the technical-sanitary regulations. As regards ingredients and processing aids, AESAN has published a list of regulations, which it has classified according to each specific subject. These lists correspond to the use of: 

• Food additives [1]
• Flavorings [2]
• Enzymes [3]
• Extraction solvents [4]
• Processing aids [5]

The use of any food ingredient will depend always on the specific food category. 

3.2 Raw Material Requirements

It is the responsibility of the company to ensure that the raw materials are in a suitable condition in terms of quality and safety, so that the final product complies with the requirements regarding additives, and contaminants, among others.

3.3 Fortification

Regulation (EC) No 1925/2006 [6] 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

No provisions were identified. For Novel foods, please refer to Section 3.8 below.

3.5 Permitted Additives

Spain had their own local regulations incorporating the EU regulations, through Royal Decree 1086/2020 of 9 December [7] it established the direct application of the harmonized regulation from the EU, including the regulation on food additives. 

The list of authorized food additives is harmonized in the EU under Regulation (EC) No 1333/2008 [8], 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 on food additives [9] is available for easy search. Food additives must comply with their individual specification defined in Regulation (EU) No 231/2012 [10].

3.6 Permitted Flavors and Colors 

Royal Decree 1086/2020 on the direct application of the EU harmonized regulation also applies to the flavoring regulations.

Regulation (EC) No 1334/2008 [11] 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 [12], 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 [13]. Only the substances listed therein 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 

Royal Decree 1086/2020 on the direct application of the EU harmonized regulation also applies for the processing aids.

Processing aids are defined in Article 3.2 (b) of Regulation (EC) No 1333/2008 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. 

At the national level, Spain has published Royal Decree 773/2023 of 3 October [14] on the regulation of processing aids used in the production and processing of foodstuffs.

3.8 Additional Notes 

Novel Food

The use of ingredients not traditionally used as food or obtained by processes not traditionally employed in the production of food may be authorized as novel foods/ingredients, in accordance with the procedures and rules laid down in EU legislation on novel food. 

Novel food is defined in Regulation (EU) 2015/2283 [15] 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 on the EU market but may be subject to specific conditions of use.

Commission Implementing Regulation (EU) 2017/247 [16] 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.

In this sense, AESAN has published a compilation of all EU legislation applicable to novel foods [17] as well as a database [18] that lists all the Foods (novel foods already authorized until 2017) that can be placed on the EU market. In the case of a novel food not listed therein but authorized at the community level (as of 2018), it can be used, following the corresponding conditions of use established in such authorization. 

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 [19].

GMO

Regulation (EC) No 1829/2003 [20] 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 [21].

Food enzyme

Regulation (EC) No 1332/2008 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.

3.9 References

1. Food additives

https://www.aesan.gob.es/AECOSAN/web/seguridad_alimentaria/ampliacion/aditivos.htm 

6. 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 

7. Royal Decree 1086/2020 of 9 December, regulating and relaxing certain conditions for the application of European Union provisions on hygiene in the production and marketing of foodstuffs and regulating activities excluded from its scope of application

https://www.boe.es/buscar/doc.php?id=BOE-A-2020-15872 

8. Regulation (EC) No 1333/2008 on food additives

https://eur-lex.europa.eu/eli/reg/2008/1333/oj

9. Additive database

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

10. 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 

11. Regulation 1334/2008 on flavourings

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

12. Royal Decree 308/1983, of January 25, approving the Technical-Sanitary Regulations of Edible Vegetable Oils https://www.boe.es/buscar/act.php?id=BOE-A-1983-5543 

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

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

14. Royal Decree 773/2023 of 3 October on the regulation of processing aids used in the production and processing of foodstuffs

https://www.boe.es/buscar/doc.php?id=BOE-A-2023-20563 

15. Novel Food Catalogue

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

16. Commission Implementing Regulation (EU) 2017/247

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

17. Compilation of all EU legislation applicable to novel foods 

https://www.aesan.gob.es/AECOSAN/web/seguridad_alimentaria/ampliacion/nuevos_ingredientes.htm 

18. Foods that can be placed on the EU market under Article 4.2, first indent of Regulation (EC) No 258/97

https://www.aesan.gob.es/AECOSAN/web/seguridad_alimentaria/ampliacion/alimentos_mercado_UE.htm 

19. Directive 2009/32/EC on extraction solvents

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

20. Consolidated text: Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02001L0018-20210327 

21. 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