The Government regulates substances other than vitamins and minerals which may contain food supplements
Post: Spanish Agency for Consumer Affairs, Food Safety and Nutrition
Date: 16 marzo 2018
Section: Seguridad Alimentaria
- At the request of the Minister for Health, Social Services and Equality, Dolors Montserrat, the Council of Ministers has approved a Royal Decree which establishes a list of these “other substances”.
- Regulations similar to that approved today have already been implemented in other Member States of the European Union, such that these products are already marketed in Spain coming from other neighbouring countries.
- The enactment of the Royal Decree guarantees consumer protection while, at the same time, competitiveness of the Spanish food business operators in the Community market is improved.
At the request of the Minister for Health, Social Services and Equality, Dolors Montserrat, the Council of Ministers has today approved the Royal Decree amending Royal Decree 1487/2009, of 26 September, on food supplements, regulating substances other than vitamins and minerals which may contain food supplements in order to improve consumer protection.
The Royal Decree establishes a list of these “other substances” which may contain food supplements, but which safeguard health.
Reports from the Scientific Committee on Human Food and the European Food Safety Authority were taken into account in the drafting of the list, together with the safety assessments carried out by other international organisations of recognised scientific standing.
In addition, the Scientific Committee of the Spanish Agency for Consumer Affairs, Food Safety and Nutrition conducted a safety assessment, establishing recommended maximum daily doses, and in some cases warnings to the end consumer to ensure the substances are consumed in safety and that the Royal Decree project has been implemented.
SUBSTANCES TRADITIONALLY CONSIDERED AS “DIETARY”
In addition, substances are included which have been traditionally considered as “dietary”, but which, under the European Union definition of dietary food, did not come under the scope of the legislation concerning “dietary” products, thereby requiring clarification on the way in which these products are marketed. These substances are: wheat germ, pollen, royal jelly, brewer's yeast, soy lecithin and propolis.
Regulations similar to that passed today have already been implemented in other Member States of the European Union, such that these products (food supplements containing substances other than vitamins and minerals) are already marketed in Spain coming from other neighbouring countries. Consequently, the enactment of the Royal Decree guarantees consumer protection while, at the same time, the competitiveness of Spanish food business operators in the Community market is improved.
The aim of the project is to permit the use of ingredients other than vitamins and minerals in the preparation of the products considered in Royal Decree 1487/2009, provided there is sufficient scientific evidence to ensure the safety of the food supplements which include these substances in their ingredients. This is in order to facilitate the task of the official control authorities and of the food business operators, while also protecting consumer health.
ANNEX: List of other substances with nutritional or physiological effect that can be used in the manufacture of food supplements
| Sustancia | Cantidad máxima diaria | Advertencias |
| Categoría 1. Ácidos grasos | ||
| ÁCIDO LINOLEICO + ÁCIDO ALFA LINOLÉNICO |
Siempre deben presentarse juntos Máximo 2 g de alfa linolénico al día. Relación linoléico/alfa linolénico: máximo 5 |
|
| ÁCIDO OLEICO | - | |
| ÁCIDO ARAQUIDÓNICO | - | |
| ÁCIDOS GRASOS OMEGA-3 (DHA + EPA) | Suma total 3 g | |
| Categoría 2. Aminoácidos (y sus sales de Na, K, Ca, Mg y HCl) y otros compuestos nitrogenados | ||
| ÁCIDO L-GLUTÁMICO | 1 g | |
| L-ALANINA | 3,6 g | |
| L-ARGININA | 3 g | |
| L-CARNITINA | L-carnitina o clorhidrato de L-carnitina 2 g |
|
| Tartrato de L-carnitina 3 g |
||
| L-CISTEÍNA | 300 mg | |
| L-GLUTAMINA | 5 g | |
| L-HISTIDINA | 1,12 g | |
| L-ISOLEUCINA | 1,5 g | |
| L-LEUCINA | 3 g | |
| L-LISINA | 2,25 g | |
| L-METIONINA+ L-CISTEINA | Suma total: 550 mg. (Metionina: máx. 250 mg y Cisteína máx. 300 mg) | |
| L-ORNITINA ALFA CETOGLUTARATO | 2 g | “No debe ser consumido por mujeres embarazadas, niños, ni durante períodos prolongados de tiempo sin control médico.” |
| L-TIROSINA + L-FENILALANINA | Suma total: 1,9 g | |
| L-TREONINA | 1,15 g | |
| L-TRIPTÓFANO | 300 mg | “No debe ser consumido por mujeres embarazadas, ni por aquellas personas que estén siendo tratadas con antidepresivos o que padezcan insuficiencia renal.” |
| L-VALINA | 1,95 g | |
| TAURINA | 1g | |
| Categoría 3: Dipéptidos y péptidos | ||
| GLUTATIÓN | 50 mg | |
| LACTOFERRINA | 200 mg | |
| Categoría 4: Coenzimas | ||
| COENZIMA Q-10 o UBIQUINONA | 200 mg | |
| Categoría 5: Flavonoides, Carotenoides | ||
| LUTEINA + trans ZEAXANTINA de Tagetes erecta | Suma total: 20 mg | “No debe ser consumido por niños.” |
| ASTAXANTINA de crustáceos y pescado | 4 mg | “No debe ser consumido por mujeres embarazadas o en período de lactancia, ni por niños.” |
| LICOPENO | 15 mg | |
| QUERCETINA | 75 mg | “No debe ser consumido por mujeres embarazadas o en período de lactancia, ni por niños.” |
| RUTINA | 150 mg | “No debe ser consumido por mujeres embarazadas o en período de lactancia, ni por niños.” |
| RUTINA + QUERCETINA | 75 mg referidos a quercetina (calculando un ratio de conversión de rutina a quercetina del 50%) | “No debe ser consumido por mujeres embarazadas o en período de lactancia, ni por niños.” |
| Categoría 6: Nucleótidos | ||
| ADENOSINA 5-MONOFOSFATO y sus sales sódicas | Suma total: 450 mg |
|
| CITIDINA 5-MONOFOSFATO y sus sales sódicas | ||
| GUANOSINA 5-MONOFOSFATO y sus sales sódicas | ||
| INOSINA 5-MONOFOSFATO y sus sales sódicas | ||
| URIDINA 5-MONOFOSFATO y sus sales sódicas | ||
| Categoría 7: Polisacáridos y Oligosacáridos | ||
| BETA-GLUCANOS | 4 g | “Evitar el consumo junto con medicamentos y otros complementos alimenticios a base de fibra.” |
| CHITOSAN obtenido de caparazones de crustáceos | 3 g |
“Un consumo excesivo puede causar malestar intestinal.” “Evitar el consumo junto con medicamentos.” |
| FRUCTO-OLIGOSACÁRIDOS (FOS) | 9 g FOS o 9 g de FOS +INULINA |
“Un consumo excesivo puede causar malestar intestinal.” “Evitar el consumo junto con medicamentos y otros complementos alimenticios a base de fibra.” |
| GLUCOMANANO de Konjac (Amorphophallus konjack Koch) | 4 g |
“Tomar el producto con mucha agua para asegurarse de que la sustancia llega al estómago.” “No ingerir justo antes de acostarse.” “Evitar el consumo junto con medicamentos y otros complementos alimenticios a base de fibra.” “Los pacientes con diabetes deben consultar con su médico antes de ingerir este complemento alimenticio.” |
| GOMA GUAR | 10 g |
“Tomar el producto con mucha agua para asegurarse de que la sustancia llega al estómago.” “Evitar el consumo junto con medicamentos y otros complementos alimenticios a base de fibra.” |
| INULINA | 9 g INULINA o 9 g de INULINA +FOS |
“Un consumo excesivo puede causar malestar intestinal.” “Evitar el consumo junto con medicamentos y otros complementos alimenticios a base de fibra.” |
| PECTINAS | 10 g |
“Tomar el producto con mucha agua para asegurarse de que la sustancia llega al estómago.” “Evitar el consumo junto con medicamentos y otros complementos alimenticios a base de fibra.” |
| Categoría 8: Otras sustancias | ||
| COLINA (como colina, cloruro, citrato o bitartrato de colina) | 1,5 g | |
| Sulfato de CONDROITINA | 500 mg | “No debe ser consumido por mujeres embarazadas o en período de lactancia, ni por niños.” |
| Monohidrato de CREATINA | 3 g | |
| GLUCOSAMINA (como sulfato o clorhidrato) | 500 mg | “No debe ser consumido por mujeres embarazadas o en período de lactancia, ni por niños ni por adolescentes.” |
| INOSITOL (como Hexafosfato de inositol o Mioinositol) | 2 g | |
| GERMEN DE TRIGO | - | |
| POLEN | - | |
| JALEA REAL | - | |
| LEVADURA DE CERVEZA (Saccharomyces cerevisiae) | - | |
| LECITINA DE SOJA | ||
| PROPOLEO | ||