Food supplements

Background: 

A legal framework has been established for food supplements since 10 June 2002 with Directive 2002/46/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to food supplements. Nevertheless, there is still a notable absence of harmonised maximum levels of vitamins and minerals according to Article 5 of the Directive, as well as a harmonised basis for the marketing of numerous “other substances”, particularly botanicals. It is therefore necessary to comply with numerous national regulations, recommendations and conventions when developing and marketing food supplements in Europe. Developments relating to quality and safety aspects are also gathering momentum at European level.

Strategic evaluation

Although the regulation of maximum levels has been under discussion for years, along with the question of which botanicals may be used and the ways in which they may be advertised, there are no solutions on the horizon for either issue. If a food supplement is to be marketed in several EU countries, an investigation must therefore be carried out to determine whether the formulation meets the requirements imposed in all target markets or whether adjustments need to be made. Botanical ingredients pose a particular challenge in this respect.

Regulatory affairs

It is therefore necessary to observe positive and negative lists established to regulate the handling of herbal ingredients at national level. As the majority of these only define plants and parts of plants, it is often necessary to clarify whether or not the chosen preparation is a novel food. We keep an eye on legal developments and offer you comprehensive advice regarding herbal and non-herbal ingredients, as well as labelling issues (mandatory information, health and nutrition claims, clean labelling).

Medical affairs

A highly dynamic development is becoming evident with respect to the safety evaluation and regulation of botanicals within the framework of Article 8 of Regulation (EC) No. 1925/2006 on the addition of vitamins and minerals and certain other substances to foods. Examples of substances currently under investigation include fennel and other plants containing estragole, schisandra (hydroxycitric acid) or plants containing hydroxyanthracene derivatives, such as aloe or rhubarb root. Other “candidates” include curcumin, piperine, synephrine and Withania somnifera (ashwagandha). A substantiated initial and continuous evaluation of herbal ingredients’ safety has become an essential factor for success. Our Medical Affairs team will support you throughout all phases of the product lifecycle.

Analysis

PhytoLab has a broad spectrum of methods at its disposal for the analysis of vitamins, minerals, trace elements, carotenoids and omega-3 fatty acids, and is playing a leading role when it comes to analysing the increasingly important secondary plant constituents. We also test the microbiological quality and stability of your products on your behalf. In this way, we offer you the best possible means of ensuring that the marketability of your products is assured from a single source.

Need for action

Do you need independent expertise on food supplements, botanicals or issues relating to the definition of boundaries to other product categories? Or are you looking for a laboratory that can offer you reliable customised solutions for your products, from the analysis of raw materials through to the finished product and stability testing? If so, you have come to the right place!

We would be delighted to help you find solutions.
Your contacts at PhytoLab:

Regulatory Affairs:

ANKE STEUBER
Phone +49 9163 88-446
anke.steuber@phytolab.de

Sales:

MARTIN MÜLLER
Phone +49 9163 88-5534
sales@phytolab.de