The question of whether a foodstuff – especially a food supplement, dietetic food or food for special medical purposes in a particular form ‑ is marketable, involves many aspects. Diapharm, with its specialised knowledge, supports manufacturers in answering the question.
Marketability verification clarifies the following points, among others:
The classification of the “active ingredient” or “characteristic ingredients” plays a decisive role in whether a food supplement is marketable as a foodstuff or not: Is a pharmacological effect potentially to be reckoned with? In this regard, the competent authorities have sometimes already clarified the appropriate classification as a foodstuff/food supplement, or as a pharmaceutical or other product category. A product can only be marketed as a food supplement if an assessment shows that it does not fall under the regulations governing medicinal products (in UK: paragraph 2 of The Human Medicines Regulation 2012). The so called demarcation of food stuffs and medicinal products results from decisions by authorities and courts of each EU-member state. This can lead to differing evaluations in different EU member states. Germany for example has established an ‘authority-organized expert group’, which deals with the demarcation of food supplements and medicines. Their reports have consideral impact on the food supplement market.
Finally, the product must meet the requirements of the European directive on food supplements 2002/46/EC; e.g. food supplements must contain “concentrated sources of nutrients” in a form “designed to be taken in measured small unit quantities” (e.g. capsules, powders). These requirements have been adopted in all EU countries through national rules and regulations, e.g. the Food Supplements (England) Regulations 2003.
In the case of products that may be on a borderline between a foodstuff, a medicinal product, cosmetic product or a medical device, Diapharm considers a variety of solution strategies.
In considering the active ingredients, “novelty” often plays a role (“Novel Food”): if an ingredient is classified as Novel Food according to Regulation (EC) 2015/2283, marketability of this ingredient is subject to an approval process different than for traditional foodstuffs.
For vitamins or minerals to be permissible in food supplements, they must be listed in the annexes of directive 2002/46/EC. In e.g. Germany, amino acids have a special status and cannot be marketed without official authorization. No special regulations exist for most of the other valuable ingredients, incl. botanicals, which often complicates rather than simplifies the evaluation of their admissibility.
In considering the verification of the marketability of ingredients, more than just the “active ingredients” need to be taken into account regarding foodstuffs or food supplements. All other ingredients contained in it must be evaluated according to their permissibility. In particular, food additives (Regulation (EU) 1333/2008) and food enzymes (Regulation (EU) 1332/2008) are subject to approval – if they are not explicitly approved, they are forbidden. Additional requirements target e.g. the usage of flavourings (Regulation (EU) 1334/2008).
Here, among others, the question of “pharmacologic effects” of characteristic ingredients needs to be asked: Could the recommended daily dose lead to consequent effects – meaning the substance can no longer be defined as a foodstuff? In the case of additives, their compliance with food additives Regulation (EC) 1333/2008 regarding defined highest quantities needs to be checked.
A large number of requirements regulate the quality and safety of food products. At the level of ingredients, and for the product itself, quality requirements must be complied with. Among others, the HACCP concept (Hazard Analysis and Critical Control Points) and the topic of product traceability are relevant. Important regulations concern other questions of foodstuff hygiene (e.g. Regulation (EC) 852/2004) and microbiological criteria of foodstuffs (Regulation (EC) 2073/2005) or maximum amounts of heavy metals, mycotoxins and other contaminants (Regulation (EC) 1881/2006).
The regulations regarding mandatory labelling and health related advertising statements (“health claims”), and especially for food supplements, are so extensive that we have compiled these on separate pages. Main rules on food information are laid down in Regulation (EU) 1169/2011. This regulation also lays down rules and labelling regulation on allergens and nano materials. Special labelling rules for food supplements are laid down in Directive 2002/46/EC. Depending on the specifications of the product, additional national and European regulations may be applicable.
You will find further details on the mandatory particulars, without which a foodstuff is not marketable, on the page Labelling. You’ll find details on health and nutrition claims (Regulations (EC) 1924/2006 and (EU) 432/2012) on our Health Claims page.
Rules for primary packing materials (bottles, blister etc.) that come into contact with foods as laid down in e.g. Regulation (EC) 1935/2004, must be observed. Depending on the actual packaging material, such as recycled materials, additional regulations may apply.
The responsibility for the product documentation lies with the company placing the product on the market. Only a complete and detailed product documentation can reduce the liability risk. The documentation often is crucial for averting harm from product and brand: Did the production comply with HACCP principles and other standards of regulations (EC) 852/2004 (hygiene of foodstuffs) and 853/2004 (hygiene rules for food of animal origin)? Are all necessary data on raw materials as well as the manufacturing process and the finished product (certificates of analysis (CoA), stability data etc.) readily available for the batches in question?
The European Commission has left it up to EU member states whether a food supplement has to be notified in the respective country before it will be placed on the market. As a result, the requirements can vary widely: whereas a food supplement can be marketed immediately in one EU state, in others the product has to be notified, which includes the submittal of various documents, in order to be marketable.