Regulatory Status for Use in Food Supplements

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Tomato Liquid Concentrate
Spain

This section provides a regulatory assessment for the use of tomato liquid concentrate in Food Supplements in Spain.

1. Regulatory Background on Food Supplements in Spain

In Spain, the Spanish Agency for Food Safety and Nutrition (AESAN) is an autonomous body attached to the Ministry of Consumer Affairs in charge of verifying the quality, safety, and innocuousness of food supplements, which are defined and classified under food legislation. The specific regulatory framework for the category is described in:

Royal Decree No 1487/2009 [1] Food Supplements, transposing EU Directive 2002/46/EC [2], which lays down a positive list of permitted vitamins and minerals; and
Its amendments in Royal Decree No 130/2018 [3], transposing Regulation (EC) No 1170/2009 [4], which includes a positive list of other permitted substances with nutritional or physiological roles that can be added to food supplements

Royal Decree No 1487/2009 provides the following definition for food supplement:

Figure 1. Excerpt from Article 2 of the Royal Decree No 1487/2009

English translation:

Article 2. Definitions.

For the purposes of this royal decree, it shall be understood as:

Food supplements: Food products whose purpose is to supplement the normal diet and consisting of concentrated sources of nutrients or other substances that have a nutritional or physiological effect, in simple or combined form, marketed in dose form that is capsules, pills, tablets and other similar forms, powder sachets, ampoules of liquid, dropper bottles, and other similar forms of liquids and powders to be taken in small unit amounts.
Nutrients: The following substances:
1. Vitamins
2. Minerals

It is worth noting that the above-mentioned regulations do not include a positive list of botanicals to be used in food supplements. Thus, AESAN has issued the Guide for the official control of the labeling and composition of food supplements [5], stating that a food supplement will be considered safe if it contains ingredients for which, without being expressly and legally authorized, there is sufficient scientific information to conclude that the food supplement does not pose a risk to the health of the people who consume it. In particular, according to the Guide, ingredients contained, among other references, in the "List of Suitable Substances for Food Supplements in other EU Member States" may be considered safe, as the product is considered safe in other EU Member States.

Figure 2. Excerpt from Guide for the official control of the labeling and composition of food supplements

English translation:

In the absence of a Spanish regulation for ingredients other than vitamins and minerals, as well as for other substances with a nutritional or physiological effect, the principles of mutual recognition will apply, and the marketing of a food supplement legally marketed in another Member State cannot be hindered, unless it is substantiated and expressly justified through the procedure established in Regulation (EC) No 764/2008 and that established in articles 11 and 12 of Directive 2002/46/EC.

2. Permitted use of Tomato Liquid Concentrate as an Active Ingredient in Food Supplements

As shown in Figure 1, food supplements may contain concentrated sources of nutrients or other substances that have a nutritional or physiological effect. Based on such definition, Royal Decree No 130/2018 which amended the Spanish food supplement regulations introduced a new annex regarding “Other substances with a nutritional or physiological effect which may be used in the manufacture of food supplements”. However, the use of tomato liquid concentrate as an active ingredient is not described in this list.

Based on product specifications and the flowchart provided, the ingredient is considered a common food not falling under Novel Food Regulation. Therefore, it is our best understanding that the ingredient, a tomato liquid concentrate, can be used in food supplements.

Furthermore, when formulating a supplement, manufacturers shall also take into consideration the fact that EFSA has set an acceptable daily intake (ADI) of 0.5 mg/kg body weight (bw) per day for lycopene from all sources [6].

Conclusion

In Spain, the use of tomato liquid concentrate is permitted as an active ingredient in food supplements. While there is no legal maximum limit, EFSA has set an ADI of 0.5 mg/kg body weight (bw) per day for lycopene from all sources.