What it covers
The analysis starts from the principle, settled in the case law of the Court of Justice of the European Union on borderline products, that a product may be a medicinal product by function, because of its actual pharmacological properties, or by presentation, because of the way it is presented to the consumer — regardless of the category under which the operator labels it. The report examines the composition of the product (doses and ingredients, particularly botanicals and other bioactive substances with a history of regulatory controversy), the function attributed to it and the way it is presented — claims, packaging, sales channel — to assess the risk that the competent authority will treat it as a medicinal product rather than as a food supplement or a food.
Classification is decided case by case by the authorities of each Member State, and the use of botanicals in food supplements is not harmonised at EU level. A product sold without difficulty in one Member State may therefore be regarded as a medicinal product in another. For an operator entering the Union, this is one of the risks least visible from outside and most costly once stock is on the market.
The result is a documentary risk report with the estimated level of exposure and, where appropriate, the changes in formulation, dose, presentation or commercial communication that would reduce it.
What it does not include
It does not include laboratory, analytical or toxicological testing: the assessment is documentary and regulatory, not a determination of the actual composition of the product, which is a matter for an accredited laboratory. Nor does it include assistance in proceedings already opened by an authority following a reclassification, which is a separate engagement.
Legal framework
Directive 2001/83/EC on the Community code relating to medicinal products for human use, in particular the definition of medicinal product in Article 1(2) and the rule in Article 2(2) that, where a product may fall both within that definition and within the definition of a product covered by other Union legislation, the provisions on medicinal products apply. This is read together with the case law of the Court of Justice on borderline products, Directive 2002/46/EC on food supplements, and the national rules of the Member State of marketing. For botanicals, whose use is not harmonised, the analysis also draws on the reference lists of other Member States, such as the BELFRIT list (Belgium, France and Italy), the Italian and Belgian national lists and the German Stoffliste.
Process
Through the quote form, the company provides the composition of the product, the function or effect it intends to communicate, and the presentation and labelling material available (packaging, technical data sheet, draft claims). The documentary analysis is carried out and the risk report is delivered within the stated timeframe.
When this is not the right service
If the doubt is not about the legal nature of the product but about whether a specific claim is covered by the list of authorised claims, the right service is the nutrition and health claims review.
If the product has already been the subject of a request or an alert from the competent authority on this question, please use the general quote form rather than this preventive service.