10 October, 2016

Nutrition consultants think about the Improvement of immobilization food supplement without motivation

 

As nutritional consultants, LegaleGo Nutrition technicians analyze the immobilizations of food supplements.

Our nutritional consultants, specifically, have analyzed the sanitary inspection carried out in the Netherlands on the REVEX-16 product from Hungary.

The reason for the alert was because the presence of synephrine in this product was detected in analyzes in amounts greater than the allowed amount.

From the European Commission, as confirmed by our nutritional consultants, this alert has been sent to all the Autonomous Communities and these in turn to the provincial districts so that each inspector in the corresponding area can visit the establishments where this product is sold or distributed.

As nutritional consultants we have been able to confirm that the health authorities are making inspections of all the establishments that are marketing this product. Until now, the inspector is proceeding with the immobilization of the products, sometimes even imposing a penalty for labeling (in case of deficiencies) or for not notifying the product (if not notified).

After the beginning of the procedure and adoption of this precautionary measure, the establishments receive a subsequent definitive resolution that will determine the origin of this measure taken (the immobilization) and will determine the actions to be carried out, either return to the supplier of origin, destruction or withdrawal of the market of them.

In the case of the REVEX-16 product, however, as in the case of many others, the minimum requirements demanded by the regulations for the adoption of the provisional detention measure are not met, as this food consultancy has been able to determine.

In this sense, article 26 of Law 14/1986, of April 25, General of Health, in relation to article 83 of the Law 16/2011, of December 23th, of Public Health of Andalusia, states that “ in the event that there is an imminent and extraordinary risk to health, the Health Authorities will adopt the preventive measures they deem pertinent ”.

Article 21.2 of the Law 2/1998, of June 15th, related to the Healthcare of Andalusia, provides that “ the competent health authorities shall adopt as many preventive measures as may be required in those activities that directly or indirectly may pose imminent and extraordinary risk to public health”.

Likewise, and in accordance with the provisions of article 72.2 of Law 30/1992, of November 26, on the Legal Regime of Public Administrations and the Common Administrative Procedure (LRJPAC, hereinafter), before initiating any procedure, they may adopt the essential measures” in cases of urgency and for the protection of the interests involved”.

Therefore, for the adoption of the precautionary measure such as immobilization there must be an imminent and extraordinary risk to public health, however, this requirement is not met in the immobilizations of the REVEX-16 product as our food consultancy has been able to verify.

The European regulations set for each country the permitted limit of synephrine whose use does not entail a health risk, being unanimous criteria that the mere presence of the substance does not pose an imminent health risk if it does not exceed the limits set.

The Belgian Royal Decree on the manufacture and marketing of food and plants, the German Food Safety Report (BFR) or the EFSA Report allow the use of the synephrine substance in food supplements by setting a limit of 20 mg whose excess could be a health risk.

Based on the fact that the mere presence of synephrine in a food supplement is not considered a health risk, it must be at the amount of substance to determine if it can be considered that the commercialization of the product can cause a risk by exceeding the limits set by health authorities.

However, in the immobilizations that are being produced by the REVEX-16 product they have not been credited in how much the synephrine substance is present in the product to determine its immobilization as our nutritional consultants have been able to confirm.

It is not proven or justified, therefore, what amount of synephrine substance is contained in the immobilized products nor is it checked if the limits set by the health authorities are exceeded, proceeding to agree the provisional measure arbitrarily and without legal support.