MALTODEXTRIN IN FOOD SUPPLEMENTS

Can a food supplement containing maltodextrin be notified directly in Spain? We explain it to you!

Maltodextrin is a polysaccharide that is commonly used in food supplements with the purpose of facilitating the storage or
preservation of the product either as a thickener or to increase the volume of the final product.
However, maltodextrin is not regulated in Regulation 1333/2008 of the European Parliament and of the Council of 16 December 2008 on
food additives, nor in other national or harmonized regulations at the European Union level.
Therefore, a priori it may lead us to think that to notify a food supplement containing maltodextrin we would have to resort to the
principle of mutual recognition since maltodextrin is an ingredient that is not included in Spanish national regulations.
We must remember that the notification of placing a food supplement on the market will be made directly to the Health Authorities
where the product is to be sold if the ingredients that make it up are included in the national health regulations or if they are harmonized ingredients. at EU
level and, in the event that the food supplement contains ingredients not regulated in national regulations, we must resort to the so-called Principle of
Mutual Recognition. We leave you the link to our post on mutual recognition in food supplements.
https://www.lexsupplements.com/en/blog/how-to-apply-mutual-recognition-in-food-supplements-20240424114933306
However, given that maltodextrin is an ingredient that is used in multiple food supplements not for its physiological or
nutritional effect but to give volume to the product or to facilitate its storage, its use would be authorized under Annex III of EC Regulation 1333. /2008, that is, "to facilitate its storage, sale, standardization,
dilution or dissolution", which implies the possibility of notifying a product containing maltodextrin under these terms directly in Spain.
LexSupplements has consulted the Spanish Agency for Food Safety and Nutrition (AESAN) on the possibility of making a direct
notification in Spain of food supplements that contain maltodextrin in their composition, used to give volume to the product and not for its value.
nutritional and, AESAN has confirmed to us that in that case it is possible to notify the product in Spain without having to resort to the Principle of Mutual Recognition.
We leave you the answer that AESAN gives us for your information:
“In relation to your query, we inform you that in Spain Royal Decree 1487/2009 and its subsequent modification Royal
Decree 130/2018, transposes Directive 2002/46/EC relating to food supplements. In said regulations you will find the substances that are in principle allowed
in Spain, such as minerals and vitamins, as long as the product cannot be considered a medicine in Spain in accordance with Directive 2001/83/EC,
modified by the Directive 2004/27/EC. In article 2.1 of Royal Decree 130/2018, you will find the literal definition:
“Food supplements: Food products whose purpose is to complement the normal diet and consist of concentrated sources of
nutrients or other substances that have a nutritional or physiological effect, in simple or combined form, marketed in dosed form, that is, capsules, pills,
tablets, pills and other similar forms, sachets of powders, liquid ampoules, dropper bottles and other similar forms of liquids and powders to be taken in
small unit quantities Each Member State has its own legislation regarding the substances and ingredients to be used in food supplements.”
For ingredients not contemplated in our regulations, it would be necessary to apply the principle of mutual recognition.
MALTODEXTRIN would be authorized for use in the formulation of nutrients or preparations for the purposes of Annex III of
Regulation EC 1333/2008 to facilitate their storage, sale, standardization, dilution or dissolution.
The labeling of food supplements must comply with the requirements of EU Regulation 1169/2011 that apply to it, as well as
the specific requirements established by Royal Decree 1487/2009.
In any case, remember that the notification of placing on the national market before the competent authority does not
exempt the operator from the responsibility of putting a safe product on the market, in accordance with EU Regulation 178/2002 on Food Safety. nor that the
product can subsequently be subject to official control.
For more information about food supplements you can consult our website:
https://www.aesan.gob.es/AECOSAN/web/seguro_alimentaria/detalle/complementos_alimenticios.htm

For information about registration and other procedures, see the link:
https://www.aesan.gob.es/AECOSAN/web/seguro_alimentaria/subdetalle/procedimiento.htm
For information on the notification of placing a food supplement on the market in Spain, you can consult all the
information on the notification procedure at the following link to a guide on notification of supplements (it is also available in English):
https://www.aesan.gob.es/AECOSAN/docs/documentos/seguro_alimentaria/registro/GUIA_1_COMPLEMENTOS_ingles.pdf”

At LexSupplements we are specialists in the review of composition, labeling and notification of food supplements both in Spain and in the rest of the countries of the European
Union (Germany, Ireland, France, Italy, Belgium, Croatia, Spain, Poland, Greece, Portugal, Romania, etc.) If you are interested in expanding this information, contact us without obligation.