Novasol Curcumin ®️ is considered as novel food

The AESAN (Food Safety and Nutrition Agency), following the discussion in the Novel Foods Working Group of the European Commission, has concluded that in the case of the ingredient Novasol Curcumin ®️ could be considered novel food due to its high bioavailability, which is advertised to be increased by up to 180%.

The decision on the status or condition of the ingredient Novasol Curcumin ®️, has been taken on the basis of the information available so far on it in the European Commission’s Novel Foods Working Group, between the competent authorities of the different Member States and the European Commission, as there are reasonable doubts about the applicability of the Regulation (EU) 2015/2283 for novel foods, due to the high bioavailability of this ingredient.

Thus, it is has been concluded by the authorities that these new applications with highly bioavailable curcuminoids would no longer correspond to the known use of curcuminoids before 1997 in food supplements, therefore Regulation (EU) 2015/2283 on novel foods would apply, falling under the category set out in Article 3(2a)(vii), i.e, “food resulting from a new production process not used for food production within the Union before 15 May 1997, which results in significant changes in the composition or structure of the food affecting its nutritional value, metabolism or level of undesirable substances”.

It also appears that the ingredient Novasol Curcumin ® contains nanomicelles in the range of 5-100 nm in its composition, so that the category set out in Article 3(2)(a)(viii) ‘food consisting of engineered nanomaterials‘ could also apply to it.

It is determined by AESAN that until the operator proves otherwise, this new presentation form of curcuminoids (Novasol Curcumin ®) is considered as a novel food, as the consumption history applied to conventional curcuminoids in food supplements is not valid.

In this regard, and on the basis of the Article 19 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, it is the duty of the food operator to place safe food on the market. Where there is reasonable doubt about their safety, the operator shall immediately remove them and inform the competent authorities.

However, as AESAN has informed LegaleGo Regulatory, the consideration of Novasol Curcumin ® as a novel food is not an official decision, as it is based on the information available so far.

Therefore, if the operator has information on the history of safe and significant consumption before 15 May 1997 of this ingredient, and since it is the operator’s obligation to place safe food on the market, he should submit an application to determine the status or condition of this ingredient to obtain an official response on its status or condition, and thus verify the applicability of the Novel Food Regulation.

No official request for the determination of the status or condition of the ingredient Novasol Curcumin has been received in any Member State so far.Therefore, until proven otherwise, it is considered as a novel food given the lack of information on the history of safe and meaningful use of this ingredient before 15 May 1997, the date of entry into application of the Novel Food Regulation, and should therefore be withdrawn from the market as indicated above either by the operator or by the competent official control authorities.

In the Autonomous Community of Valencia, in fact, the health authorities are already sending injunctions to companies that are selling food supplements with this ingredient for their withdrawal.