Regulatory Status for Use in Dietary Supplements
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Regulatory Status for Use in Dietary Supplements
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Tomato Liquid Concentrate
Germany
This section provides a regulatory assessment for the use of Tomato Liquid Concentrate in Food Supplements in Germany.
1. Regulatory Background on Dietary Supplements in Germany
In Germany, dietary supplements are regulated in the Dietary Supplement Regulation (NemV, NahrungsergänzungsmittelVO) [1] as shown below.
Figure 1. Excerpt from Article 1 of the Dietary Supplement Regulation
English translation:
"(1) Dietary supplements as stipulated in this regulation are those
- destined to supplement the normal nutrition
- referring to the concentration of nutrients or other substances with specific nutritional or physiological effects alone or in combination
- to be brought onto the market in a dosed form, especially as capsules, pastilles, tablets, pills, or other similar dosage forms of liquids and powders for intake in measured, small quantities.
(2) Nutrients as stipulated in this regulation are vitamins and minerals including trace minerals."
Article 3 of the regulation describes the approved substances that can be added to a dietary supplement, with reference to the Directive 2002/46/EC [2] on the list of permitted forms of vitamins and minerals.
Figure 2. Excerpt from Article 3 of the Dietary Supplement Regulation
English translation:
"§3 Approved Substances
(1) In the production of a food supplement, only those nutrients listed in Annex I to Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ. L 183 of 12.7.2002, p. 51) within the meaning of § 1 paragraph 2 are used in the forms listed in Annex II to Directive 2002/46/EC. Annexes I and II to Directive 2002/46/EC are in each case in the 5th December 2011 version (OJ. L 296 of 15.11.2011, p. 29).
(2) The provisions of Annex II to Directive 2002/46/EC, which on the 5th December 2011 version (OJ. L 296 of 15.11.2011, p. 29), subject to sentence 2, the substances specified in Commission Regulation (EU) No 231/2012 of 9 March 2012 with specifications for the food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83 of 22.3.2012, p. 1), as amended, comply with the purity requirements. Substances of Annex II to Directive 2002/46/EC, which on the 5th December 2011 version (OJ. L 296 of 15.11.2011, p. 29), which are not listed in Regulation (EU) No. 231/2012, must comply with the purity requirements achievable in accordance with the generally accepted rules of technology."
By the definition shown in Figure 1, other substances with specific nutritional or physiological effects can be added to a dietary supplement.
For botanicals, in Germany, these are under the responsibility of the BVL (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, or Federal Office of Consumer Protection and Food Safety) in the “Stofflisten” (lists of substances) [3]. As described in Chapter 1.2 of the BVL list, for the use of substances other than vitamins and minerals for food supplements, the manufacturer may refer to Annex III of Regulation (EC) No. 1925/2006 on substances that are prohibited, restricted, or under scrutiny by the EU [4].
Figure 3. Excerpt from Chapter 1.2 of the BVL List of Botanical Substances
English translation:
"Which vitamin and mineral compounds may be used in food is standardized throughout Europe in the annexes to Directive 2002/46/EC, Regulation (EU) No. 609/2013, and Regulation (EC) No. 1925/2006 (Enrichment Ordinance) regulated in detail. However, the permissible maximum quantities are not regulated. For substances that are not vitamins or minerals, there are currently no specific regulations such as binding specifications, maximum or minimum quantities.
However, the legal prerequisites for the regulation of substances other than vitamins and minerals were already created with Regulation (EC) No. 1925/2006. The procedure regulated in Art. 8 of this ordinance opens up the possibility of such other substances that should not be used in the production of food (including fortified food, dietary supplement, and supplementary balanced diet) if they are harmful to health and therefore prohibited in food in Annex III Part A, or if they may only be used under certain conditions, in Annex III Part B. Substances that may be harmful to health when used in food, but for which there is scientific uncertainty, are included in Part C of Annex III."
2. Permitted Use of Tomato Liquid Concentrate as an Active Ingredient in Dietary Supplements
The use of tomato liquid concentrate as an active ingredient is not described in any list of the BVL. However, based on the product specifications and processing flowchart provided, the ingredient of interest is considered a common food not falling under the Novel Food Regulation. Therefore, it is our best understanding that the ingredient, a tomato liquid concentrate, can be used in dietary supplements.
It is worth noting that the BVL list of authorized plants added to food does not provide restrictions for tomato and their preparation (including tomato liquid concentrate).
Figure 4. Excerpt from the BVL List of Botanical substances on Solanum lycopersicum
However, when formulating a supplement, manufacturers to 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 [5].
For information, lycopene from tomatoes is authorized as a novel food in the EU with a maximal daily level in food supplements of 15 mg/day [6].
Conclusion
Liquid tomato concentrate can be used as a food in order to contribute to lycopene content. If tomato concentrate is used alone in the recipe, the level of lycopene shall have a physiological effect. If it is used in combination with lycopene substance, tomato concentrate increases the overall level of lycopene. 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.
3. References
1. Dietary Supplements Regulation (NemV - NahrungsergänzungsmittelVO)
https://www.gesetze-im-internet.de/nemv/__1.html
2. Directive 2002/46/EC – Approximation of the laws of the Member States relating to food supplements
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02002L0046-20220930
3. List of botanical substances from the federal and state governments with participation of experts from Germany, Austria and Switerland (Pflanzenliste L – Z, Stofflisten des Bundes und der Bundesländer)
[Foreword]
[List]
4. 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%3A02006R1925-20221221
5. EFSA assessment on safety of lycopene in foods
https://www.efsa.europa.eu/en/news/efsa-assesses-safety-lycopene-foods
6. Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R2470-20230412
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