11 October, 2016

Alert imposed on the substance Synephrine

A new alert generated in the Rapid Alert System of Europe (RASFF), as a result of a sanitary inspection carried out in the Netherlands on the REVEX-16 product, of the SCITEC NUTRITION brand from Hungary.

The reason for the alert was for having analyzed the presence of synephrine in this product in quantities greater than the amount allowed by the applicable legislation in the country where the alert was generated.

From the European Commission this alert has been sent to all the Autonomous Communities and these in turn to the provincial districts so that each inspector of the corresponding area visits the establishments where this product is sold or distributed. Hence the importance of proper legal advice in sports nutrition.

From LegaleGo Sport Nutrition, experts in review and notification of labeling of food products, we confirm that the health authorities are making inspections of all the establishments that are marketing this product, which at the moment is based on the immobilization of the products arriving sometimes even to impose any 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. It is unknown how much the synephrine substance is present in the product to determine its immobilization, proceeding to agree the provisional measure arbitrarily and without legal support.

In the case of the REVEX-16 product, however, as in many others, the minimum requirements required by the regulations for the adoption of the provisional immobilization measure are not met. 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 56.2 of Law 39/2015, of October 1, of the Common Administrative Procedure of Public Administrations, before initiating any procedure, the essential measures may be adopted “in cases of urgently urgent and for the protection of the interests involved ”.

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.