Despite reform, no change in national legislation on the fortification of foods with vitamins and minerals
Not only since the Corona pandemic have foods that promise consumers health benefits due to their ingredients enjoyed particular popularity. A conscious, healthy diet has been part of many people’s daily routine for years. If the regular diet alone does not provide enough vitamins, or if there is an increased need for example due to a tight fitness regime consumers can supplement with appropriate products. Numerous of such foods fortified with vitamins or minerals can be found in the product portfolios of food retailers.
The need for a uniform regulation of these foods is obvious. Hence, as early as 2007 the Regulation (EC) No. 1925/2006 (hereinafter referred to as the “Fortification Regulation“) entered into force. However, this regulation still does not provide an answer to the crucial question, how much vitamins and minerals may be added. This leads to the fact that the partly very different national regulations are still applied. In particular, the German regulations are not compatible with the fundamental ideas of the Fortification Regulation. To the chagrin of food companies in particular, the German legislator has also failed to remedy the situation with the latest reform of the German Food and Feed Code, the so called “Lebensmittel- und Futtermittelgesetzbuch” (in the following referred to as “LFGB”).
Applicability of the Fortification Regulation
The Fortification Regulation stipulates that only the vitamins and minerals listed in Annex I of the Fortification Regulation may be added to foods (Art. 3 para. 1 Fortification Regulation). Further conditions of the addition, such as that it should not be made to alcoholic beverages, are then set out in the following articles. Art. 6 of the Fortification Regulation also provides for compliance with maximum and minimum levels. With regard to the latter, the Fortification Regulation refers in Article 6 para. 6 to the significant amount of the Annex to Directive 90/496/EEC, which has since been replaced by Regulation (EU) No 1169/2011 (hereinafter referred to as the “Food Information Regulation”). In the latter, the significant amount – and thus the minimum levels – are regulated in Annex XIII Part A No. 2 of the Food Information Regulation. However, the situation is different and much more problematic with regard to the maximum levels. So far, there are no set maximum levels for the respective vitamins and minerals, although Article 6 para. 1 of the Fortification Regulation stipulates that such maximum levels are to be set throughout the EU. This circumstance leads to the fact that the transitional regulation of Article 17 para 3 of the Fortification Regulation and thus corresponding national regulations, which determine maximum levels or other conditions of the addition, continue to apply.
Since it is still not foreseeable when the urgently required maximum levels will be set by the EU, some countries – such as Denmark – have meanwhile taken the initiative and set their own maximum levels. In Germany, too, this is a recurring topic of debate. Only in March of last year, the BfR updated the proposed maximum levels for the fortification of foods and food supplements with vitamins and minerals. These are available here on the BfR homepage (last accessed on 13.12.2021).
National German law
In Germany, the addition of vitamins and minerals was regulated until recently in Sec. 6 (1) in conjunction with Sec. 2 (3) sentence 2 LFGB. Which provided a blanket ban applied with the possibility of a reservation of permission by way of an exceptional approval or a general disposition. These regulations are obviously in considerable contradiction to the regulations of the Fortification Regulation, which in principle allow the addition. Said provisions are therefore simply incompatible with Union law.
Already a few years ago, the ECJ expressed considerable concerns about the compatibility of the German blanket ban on amino acids with EU law (Court ruling of 19 January 2017, C 282/15). This was ultimately also the reason for the welcome reform of the relevant sections of the LFGB.
Against this background, it is surprising that the repealed regulations, which are contrary to EU law, should continue to apply on the basis of the transitional provision in Sec. 1a (1) of the Act on the Transition to the New Food and Feed Law (LMFR-ÜG) until there are either EU-wide or national requirements for the addition of vitamins and minerals – such as the urgently required maximum levels. Only the former equation of amino acids and food additives in Sec. 2 para. 3 no. 3 LFGBaF is not covered by this transitional regulation, whereby the German legislator obviously wants to comply with the findings of the above-mentioned ECJ ruling.
Despite a reform of the LFGB and the repeal of the relevant provisions, there is thus initially no change to the current national legal situation, which is contrary to EU law. The opportunity of the reform should have been used to regulate this area comprehensively.
Conclusion
Even if the most recent reform of the LFGB initially gave the impression that the legal framework regarding the fortification of foods with vitamins and minerals, which has been contrary to EU law for years, was finally being remedied, it is now obvious that this condition will probably persist for a while yet. It is high time that safe and reliable regulations are issued for the constantly growing market in fortified foods. There is a considerable discrepancy between the legal situation and the way it is handled in practice, which is neither in the interests of the competent authorities, nor of food business operators, and certainly not of consumers. Fixed maximum levels should be set by the EU in order to establish uniform standards throughout the Union and thereby also make a de facto contribution to the implementation of the free movement of goods.
Authors:
Dr. Thomas C. Körber, attorney-at-law, specialist in intellectual property law and sports law
Fiona Trabold, attorney-at-law, specialist in intellectual property law