Resumen:
Un informe de estudio de 29 de abril de 2009 realizado por Agra CEAS Consulting relativo a la revisión de la Directiva 2009/39/CE sobre "alimentos para usos especiales" confirmó que un número cada vez mayor de productos alimenticios se comercializaban y etiquetaban como aptos para alimentación especial amparados en la amplia definición que establece esa Directiva pero con significativas diferencias entre Estados miembros debido a su diferente clasificación. A un mismo tiempo otras normativas permitían regular adecuadamente algunas de las categorías de alimentos cubiertas por la Directiva 2009/39/CE con una mayor claridad en cuanto a su ámbito de aplicación y objetivos, como la Directiva 2002/46/CE sobre complementos alimenticios, el Reglamento (CE) no 1924/2006 relativo a las declaraciones nutricionales y de propiedades saludables en los alimentos y el Reglamento (CE) no 1925/2006 sobre la adición de vitaminas, minerales y otras sustancias determinadas a los alimentos. De esta manera vino a publicarse el Reglamento (UE) nº 609/2013 de junio de 2013 relativo a los alimentos destinados a los lactantes y niños de corta edad, los alimentos para usos médicos especiales y los sustitutivos de la dieta completa para el control de peso, quedando derogada entre otras la Directiva 2009/39/CE. El nuevo Reglamento no deja lugar a dudas sobre el carácter "alimentario" de este tipo de productos quedando totalmente abolido el concepto de «alimentos destinados a una alimentación especial».
The new European Regulation 609/2013, leaves no doubt about the character of this kind and food products, despite their undeniable medical connotations. The Directive 2009/29 recognizes the incorrect classification is being done in practice and it is expected that with the new definitions these confusions are well resolved.
Regulation (EU) No 609/2013 of the European Parliament, effective from 2016, has come to unify criteria:
A.-Infant Formulas and Follow-on formulas (repealing Directive 2006/141 / EC and Directive 92/52 / EEC).
B.-Processed cereal-based foods and Baby Foods (repealing Directive 2006/125 / EC and the EC Regulation No 41/2009).
C.-Foods for Special Medical Purposes (repealing Directive 1999/21 / EC).
D.-Substitutes complete diet for weight control (repealing Directive 96/8 / EC).
NOTE 1: The new regulation repeals Directive 2009/39 / EC and abolishes the concept of "foods for particular nutritional uses".
NOTE 2: The milk-based beverages and similar for young children (from 1-36 months), are regulated in the European Union by the EC Regulations 178/2002 and 1924/2006 and 1925/2006 and Directive 2009 / 39, but have to be reported before June 20, 2015 by the Commission for possible future legislation….
NOTE 3: The new regulation defines INFANT, less than 12 months; YOUNG CHILDREN, of 12-36 months.
NOTE 3: The new regulation defines BABY FOOD, for infants and young children aged HEALTHY, except milk-based drinks (Note 2); FOOD FOR SPECIAL MEDICAL PURPPOSES those for patients, including infants, whose ability to ingest, digest, absorb, metabolize or excrete ordinary foodstuffs or certain nutrients or metabolites is limited, poor, or is altered, or need other nutrients not they can be handled with the normal diet.
NOTE 4: Do not attributed to the labeling, presentation and / or advertising of the four groups indicated properties of prevention, treatment or cure of human disease, or refer to, except to the diffusion of qualified individuals competent care mother-child, doctors, pharmacists and nutritionists.
CONCLUSIONS:
1. According to the new Regulation 609/2013 (see Note 3), the Formula's and RUTF (Ready-to-Use Therapeutic Food) products used for the treatment of SAM (Severe Acute Malnutritionin) children of 6 to 59 months should be considered "Foods for Special Medical Purposes" and that meet specific nutritional needs and premature infants. WHO Guidelines state that use of Formulas or RUTF should always be provided and monitored by a skilled health worker.
2. In relation to it as "food" or "drugs", the consideration 25 of the new regulation, leaves no doubt: "... The reference to dietary management of diseases, disorders or conditions for which it is intended food should not be considered an attribution of ownership of prevention, treatment or cure of human disease "...... Therefore these products should NOT be considered Medicines at European level, but food.
3. International standards for food are to found in the "Codex Alimentarius". Regulations in the EU, USA and other countries refer to control authorities that are linked to Ministries of Agriculture or Industry and Commerce and are specialized in the control of food products. According to the new Regulation 609/2013 the four food groups listed, remain subject (except possible exceptions of the new Regulation 609/2013) to quality and labeling regulations in force till now:
NOTE 2: The milk-based beverages and similar for young children (from 1-36 months), are regulated in the European Union by the EC Regulations 178/2002 and 1924/2006 and 1925/2006 and Directive 2009 / 39, but have to be reported before June 20, 2015 by the Commission for possible future legislation….
NOTE 3: The new regulation defines INFANT, less than 12 months; YOUNG CHILDREN, of 12-36 months.
NOTE 3: The new regulation defines BABY FOOD, for infants and young children aged HEALTHY, except milk-based drinks (Note 2); FOOD FOR SPECIAL MEDICAL PURPPOSES those for patients, including infants, whose ability to ingest, digest, absorb, metabolize or excrete ordinary foodstuffs or certain nutrients or metabolites is limited, poor, or is altered, or need other nutrients not they can be handled with the normal diet.
NOTE 4: Do not attributed to the labeling, presentation and / or advertising of the four groups indicated properties of prevention, treatment or cure of human disease, or refer to, except to the diffusion of qualified individuals competent care mother-child, doctors, pharmacists and nutritionists.
CONCLUSIONS:
1. According to the new Regulation 609/2013 (see Note 3), the Formula's and RUTF (Ready-to-Use Therapeutic Food) products used for the treatment of SAM (Severe Acute Malnutritionin) children of 6 to 59 months should be considered "Foods for Special Medical Purposes" and that meet specific nutritional needs and premature infants. WHO Guidelines state that use of Formulas or RUTF should always be provided and monitored by a skilled health worker.
2. In relation to it as "food" or "drugs", the consideration 25 of the new regulation, leaves no doubt: "... The reference to dietary management of diseases, disorders or conditions for which it is intended food should not be considered an attribution of ownership of prevention, treatment or cure of human disease "...... Therefore these products should NOT be considered Medicines at European level, but food.
3. International standards for food are to found in the "Codex Alimentarius". Regulations in the EU, USA and other countries refer to control authorities that are linked to Ministries of Agriculture or Industry and Commerce and are specialized in the control of food products. According to the new Regulation 609/2013 the four food groups listed, remain subject (except possible exceptions of the new Regulation 609/2013) to quality and labeling regulations in force till now:
- Regulation EC No 178/2002 on scientific and technical assessment of the European Food Safety Authority
- Pesticide residue limits established in EC Regulation No 396/2005.
- Labeling and information requirements of EU Regulation No 1169/2011 (gluten, lactose ....).
- Nutrition and health claims under the EC Regulation No 1924/2006.
- Vitamins, minerals, amino acids, etc. they can be added to these food groups are established in the Annex to Regulation 609/2013.
- The substances added for technological purposes (flavors, colors, etc ...) shall be governed by the rules of "Food Additives" of the EU.
- May be used the new food ingredients referred to in Article 1 of the EC Regulation No 258/97 if meet their requirements.The criteria of purity and quality of the substances must correspond to those published in the EU. Where no purity criteria published in the EU, the FAO / WHO Joint Committee (JECFA) and the European Pharmacopoeia shall apply.
- All those delegated acts adopted by the European Commission on composition, use of pesticides, labeling, reporting, etc. on these products.
SITUATION IN SPAIN
The situation in Spain for Groups A and B of the new Regulation 609, is governed by the following provisions established in the old European regulatory framework:
1. Royal Decree 1091/2000 (based on the old Directive 1999/21 / EC): Sanitary Technical Regulations (RTS) for “Dietetic and Special Medical Uses Food”. The "Food for special medical uses" are registered in the Registry General Health Food of the Ministry of Health. Include those known as "Enteral Nutrition" (three types: complete, nutrient supplements and nutrient isolated modules).
2. Royal Decree 867/2008 (based on the old Directive 2006/141 / EC): Sanitary Technical Regulation (RTS) of Infant Formula.
The situation in Spain for Groups A and B of the new Regulation 609, is governed by the following provisions established in the old European regulatory framework:
1. Royal Decree 1091/2000 (based on the old Directive 1999/21 / EC): Sanitary Technical Regulations (RTS) for “Dietetic and Special Medical Uses Food”. The "Food for special medical uses" are registered in the Registry General Health Food of the Ministry of Health. Include those known as "Enteral Nutrition" (three types: complete, nutrient supplements and nutrient isolated modules).
2. Royal Decree 867/2008 (based on the old Directive 2006/141 / EC): Sanitary Technical Regulation (RTS) of Infant Formula.
