The maximum authorized levels (MPLS) of vitamins and minerals must be fixed by the Food Supplements and Regulation Directive governing the addition of nutrients to food. The European Commission recently resumed its work on the setting of MPLS and the intention to finalize it at the end of its current mandate. For food supplement companies, this will facilitate access throughout the single market. For consumers, it will offer more choices and greater confidence in the safety of their food Food surveys in Europe show that it is necessary to make supplementation. These studies show that, while Western populations tend to consume too much macronutrients (carbohydrates, greases, proteins), some population groups simply do not consume enough micronutrients (vitamins and minerals) to maintain a healthy lifestyle.
Recital 3 of the 2002/46 / EC Food Supplement Directive stresses that, although “adequate and varied diet may in normal circumstances providing all the nutrients needed to maintain a healthy life, investigations show that this Ideal location is not realized for all nutrients and by all groups of the population across the community. In light of this, several national authorities recommend that some people occupy some form of supplementation.
As it is clearly necessary to make supplementation, we must also ensure that maximum levels are defined using an accepted scientific assessment of security so that consumers can make decisions as informed as possible A first attempt to fix MPLS in the mid-2000s was strewn with scientific and technical challenges. In the absence of harmonized levels, many Member States have developed their own national solutions, which prevents the market.
As an independent scientific and regulatory consultant, I worked with the European Federation of Associations of Health Products Manufacturers (HMP) to propose a feasible solution for food supplements. As a European organization representing the food supplement sector, EHPM works proactively and constructively with EU institutions to contribute to the development of a more common European regulatory framework for the sector. This work has been developed with technical experts from the regulatory and quality working group of the EHPM and with the Board of Directors of EHPM.
The key parameters for the MPLS definition are the higher secure admission level for vitamin or mineral of all sources (as defined by EFSA) and the usual consumption of the diet. To the extent possible, the contribution is subtracted from the higher level of security to determine the space available in the diet of people for supplements. The challenges include gaps in dietary admission data across Europe, determining the best data to use, as well as gaps in higher security level data.
How to define MPLS for food supplements and for fortified foods (foods with added nutrients) is another dilemma. A recent in-depth academic analysis has given new information to the setting of MPLS. For example, the analysis of Irish food intake data confirmed that MPL for fortified foods and supplements can be defined separately, each taking into account the consumption of other dietary sources.
The EHPM model proposes a solution to define maximum and minimum quantities in safe dietary supplements for consumers, is based on a robust scientific approach and allows consumers to make more informed food decisions. It also gives consumers more choices and ongoing benefits once the synony MPL is defined. The model also offers a solution for children’s supplements.