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Royal Decree 1487/2009, Of 26 September Concerning Food Supplements.

Original Language Title: Real Decreto 1487/2009, de 26 de septiembre, relativo a los complementos alimenticios.

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Royal Decree 1275/2003 of 10 October 2003 on food supplements incorporated into national law Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on food supplements approximation of the laws of the Member States relating to food supplements.

In view of the observations made by the European Commission, it has been considered appropriate to proceed with the repeal of Royal Decree 1275/2003 and to draw up a new royal decree which is fully in line with the requirements of the Directive 2002 /46/EC.

Therefore, the objective of this new royal decree continues to be to regulate those food products consisting of concentrated sources of nutrients and which are presented in order to supplement the intake of such nutrients in the normal diet, as although in normal circumstances, a proper and balanced diet provides all the necessary nutrients for the normal development and maintenance of a healthy organism, the research carried out shows that this ideal situation is not given in practice for all nutrients, nor for all population groups.

There is a wide range of nutrients and other elements that may be present in food supplements including, among others, vitamins, minerals, amino acids, essential fatty acids, fiber, various plants, and herbal extracts.

In the case of vitamins and minerals, it is essential that the chemical substances used in the manufacture of food supplements not only present no danger, but also that they are available to the body, by What has been established normatively a positive list of these substances.

In the manufacture of food supplements the substances which have been approved by the Scientific Committee for Food may also be used on the basis of the criteria mentioned for use in the the manufacture of food intended for infants and young children, and other foods for particular nutritional uses.

In accordance with current Community legislation, this royal decree only lays down the specific rules for vitamins and minerals used as ingredients in food supplements, which can be to be regulated at a later stage, and once adequate scientific data are available, the specific rules for other nutrients and ingredients used as ingredients in food supplements, such as: amino acids, essential fatty acids, fibre and various plants and plant elements.

Taking into account that consumers may decide to supplement their nutrient intake by consuming these products, and considering that excessive and continuous intake of these products may have harmful effects for health, it is still necessary to establish maximum levels for certain nutrients in such a way as to ensure that the normal use of these products in accordance with the manufacturer's instructions for use does not present a danger to consumers.

Until maximum levels of nutrients or other substances with a nutritional or physiological effect are fixed within the European Union for the purposes of food supplements, the relevant reports of the Committee shall be taken into account. Scientist for Food and other international bodies of recognised scientific solvency.

In addition, to ensure that these products allow the purpose of supplementing the intake of vitamins and minerals in the usual diet, these substances must be found in significant quantities in the supplements. food.

This provision has been submitted to the procedure for information on technical standards and regulations and regulations relating to the services of the Information Society provided for in Directive 98 /34/EC of the European Parliament and of the Council. The European Parliament and the Council of 22 June, as amended by Directive 98 /48/EC of 20 July, as well as Royal Decree 1337/1999 of 31 July, which incorporates these directives into the Spanish legal order.

In its processing, the autonomous communities have been consulted, as well as the sectors affected having issued its mandatory report the Inter-Ministerial Commission for Food Management.

This royal decree is issued in accordance with the provisions of article 149.1.16. of the Constitution in the field of bases and general coordination of health.

In its virtue, on the proposal of the Ministries of Health and Social Policy and the Environment, and the Rural and Marine Environment, in agreement with the Council of State and after deliberation of the Council of Ministers of the 2009,

DISPONGO:

Article 1. Object and scope of application.

1. This royal decree lays down the composition and labelling requirements applicable to food supplements which are marketed as foodstuffs and presented as such. These products will be delivered to the final consumer only prepackaged.

2. This royal decree shall apply to undertakings for the production, processing, packaging, storage, distribution, import and marketing of the products defined in paragraph 1.

3. This royal decree will not apply to medicinal products as they are regulated by Law 29/2006, of July 26, of guarantees and rational use of medicines and medical devices, as well as the different rules that regulate such products. products.

Article 2. Definitions.

For the purposes of this royal decree, it is understood by:

1. Food supplements: Food products intended to supplement the normal diet and consisting of concentrated sources of nutrients or other substances having a nutritional or physiological effect, in simple or combined form, marketed in a dosed form, i.e. capsules, tablets, tablets, pills and other similar forms, bags of powders, ampoules of liquid, bottles with dropper and other similar forms of liquids and powders to be taken in small unit quantities.

2. Nutrients: The following substances:

a) Vitamins.

b) Minerals.

Article 3. Purity ingredients and criteria.

1. In the case of vitamins and minerals, only the vitamins and minerals listed in Annex I and in the forms listed in Annex II may be used in the manufacture of food supplements.

2. For the substances listed in Annex II, the purity criteria laid down in Community legislation for their use in the manufacture of foodstuffs for purposes other than those provided for in this Directive shall apply. decree.

3. For the substances listed in Annex II for which Community legislation does not specify purity criteria, and until such specifications are adopted, the criteria recognised by the Spanish legislation shall apply if they are more These are strictly recommended by international bodies and, if not, the latter will apply.

Article 4. Conditions of the industries.

The processing and packaging industries of the products covered by this royal decree must comply with the provisions of Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs.

Article 5. Labelling, presentation and advertising.

1. The labelling, presentation and advertising of the products covered by this standard must comply with the provisions of Royal Decree 1334/1999 of 31 July, approving the General Standard for the labelling, presentation and advertising of food products.

2. For the purposes of applying Article 6.1 of Royal Decree 1334/1999 of 31 July, the name in which the products falling within the scope of this royal decree are placed on the market must be 'food supplement'.

3. The labelling, presentation and advertising of food supplements shall not include any statement stating or suggesting that a balanced and varied diet does not provide adequate amounts of nutrients in general.

4. The labelling, presentation and advertising shall not attribute to food supplements the property of preventing, treating or curing a human disease, nor shall it refer in any way to such properties.

5. Without prejudice to the provisions of Royal Decree 1334/1999 of 31 July, the following information is mandatory on the labelling:

(a) the designation of the categories of nutrients or substances that characterise the product, or an indication of the nature of such nutrients or substances;

b) the recommended product dose for daily consumption;

(c) the warning not to exceed the expressly recommended daily dose;

d) the express statement that food supplements should not be used as a substitute for a balanced diet;

e) the indication that the product should be kept out of reach of younger children.

Article 6. Specific tagging.

The amount of nutrients or substances with a nutritional or physiological effect contained in the product shall be declared on the label in numerical form. For vitamins and minerals the units listed in Annex I shall be used.

The declared quantities of nutrients or other substances shall be per dose of the product, as recommended by the manufacturer on the label for daily consumption.

The information on vitamins and minerals will also be expressed as a percentage of the reference values mentioned, if any, in the Annex to Royal Decree 930/1992 of 17 July, approving the labelling rule on nutritional properties of foodstuffs. The percentage of the reference values for vitamins and minerals may also be shown in graphic form.

Article 7. Average values.

The declared values referred to in Article 6 (1) and (2) shall be average values based on the manufacturer's analysis of the product.

Article 8. Administrative records.

The companies responsible for the production, processing, packaging, storage, distribution, import and marketing of the products regulated by this royal decree, will be subject to the provisions of the Royal Decree 1712/1991, of November 29, on the General Health Registry of Food.

Article 9. Product marketing information.

1. In order to facilitate the effective monitoring of food supplements, the person responsible for placing the product on the market in Spain must notify the competent authorities of their placing on the national market by sending them a copy of the product with prior or simultaneous character to the first placing on the market.

Such a mandatory notification must be made by the manufacturer, or the person responsible for the first placing on the market or the importer, in the case of third countries.

For the purposes of the above paragraph:

(a) The notification of the placing on the domestic market of food supplements, of domestic manufacture or from other countries belonging to the European Union, shall be submitted to the bodies of the autonomous community. competent by reason of the registered office of the manufacturer or the person responsible for the first placing on the market. The Autonomous Communities shall inform the Spanish Food Safety and Nutrition Agency for their knowledge of the notifications they receive.

(b) They shall be submitted to the Spanish Food Safety and Nutrition Agency directly or by any of the means provided for in Article 38.4 of Law 30/1992 of 26 November of the Legal Regime of the Public administrations and the Common Administrative Procedure, notifications of food supplements where, even if the supplements of countries belonging to the European Union are being carried out, the person responsible does not have his registered office social in Spain or when they come from third countries.

2. The Spanish Food Safety and Nutrition Agency shall establish the necessary mechanisms to allow access by the competent services of the Ministry of the Environment, and the Rural and Marine Environment to the notifications made to the authorities. The competent authorities of the Member States shall be responsible for placing on the national market the food supplements, whether they originate from the person responsible for the first placing on the domestic market or the importer, in the case of third countries.

Article 10. Precautionary measures.

If the Spanish Food Safety and Nutrition Agency, based on a detailed motivation for the existence of new data or a new assessment of existing data, considers that the use of a food supplement jeopardises human health despite complying with the provisions in question, may suspend or provisionally limit the application of those provisions within its territory, and shall forthwith inform the Commission of the Union European and other Member States, specifying the reasons for their decision.

Article 11. Sanctioning regime.

1. Without prejudice to other provisions which may be applicable, failure to comply with the provisions of this royal decree may be the subject of an administrative penalty, subject to the instruction of the appropriate administrative file, in accordance with Article 1 (2) of Regulation (EU) No as provided for in Chapter VI of Title I of Law 14/1986 of 25 April, General of Health.

2. In particular, the failure to comply with Article 4.1 (b), (c) and (d), and in paragraph (a) of Article 4 (a) of Article 4.1 is deemed to be a serious fault where it is at risk to public health, to Royal Decree 1334/1999 of 31 December 1999. The general rules for the labelling, presentation and advertising of foodstuffs, as laid down in Article 35.B (1) of Law 14/1986 of 25 April of 25 April, are hereby approved. In addition, under the same legal provision, the failure to comply with Article 5 (3), (4) and (5) and the omission of the notification provided for in Article 9 of this royal decree is deemed to be serious.

Single transient arrangement. Marketing extension.

Until 31 December 2009, the use of vitamins and minerals not listed in Annex I, or in the forms not listed in Annex II, may be permitted provided that the following two conditions are met:

(a) that the substances concerned are used in one or more food supplements placed on the market in the European Union before 12 July 2002.

(b) The European Food Safety Authority has not issued any negative opinion concerning the use of such substances or their use in such form, in the manufacture of food supplements, on the basis of a the dossier of support for the use of the substance concerned, and which the Member State concerned shall submit to the Commission by 12 July 2005 at the latest.

Single repeal provision. Regulatory repeal.

Royal Decree 1275/2003 of 10 October 2003 concerning food supplements is hereby repealed.

Final disposition first. Marketing restrictions.

In accordance with the provisions of the Treaty establishing the European Community, national restrictions or prohibitions in force on food supplements containing nutrients not included shall continue to apply. in the list in Annex I or in the forms not included in Annex II.

Final disposition second. Competence title.

This royal decree, has the character of basic legislation and is dictated by the provisions of article 149.1.16. of the Constitution, which attributes to the State competence on the basis and general coordination of health.

Final disposition third. Incorporation of European Union law.

This royal decree incorporates into Spanish law Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to the food supplements.

Final disposition fourth. Faculty of development.

The Ministers of Health and Social Policy and the Environment and Rural and Marine Environment are empowered to jointly adopt the necessary measures for the development and implementation of this royal decree and, in particular, to amend or update their Annexes to bring them into line with Community legislation or to include nutrients or other substances which have a nutritional or physiological effect which have not been regulated at European Union level.

Final disposition fifth. Entry into force.

This royal decree will enter into force on the day following its publication in the "Official State Gazette".

Given in Madrid, on September 26, 2009.

JOHN CARLOS R.

The First Vice President of the Government and Minister of the Presidency,

MARIA TERESA FERNANDEZ DE LA VEGA SANZ

ANNEX I

Vitamins and minerals that can be used in the manufacture of food supplements

1. Vitamins:

Vitamin A (µ g RE).

Vitamin D (µ g).

Vitamin E (mg αTE).

Vitamin K (µ g).

Vitamin C (mg).

Vitamin B1 (mg).

Vitamin B2 (mg).

Niacin (mg NE).

Vitamin B6 (mg).

Folate (µ g).

Vitamin B12 (µ g).

Biotin (µ g).

Pantothenic acid (mg).

2. Minerals:

Sodium (mg).

Chlorine (mg).

Potassium (mg).

Calcium (mg).

Phosphorus (mg).

Magnesium (mg).

Iron (mg).

Zinc (mg).

Manganese (mg).

Copper (µ g).

Iodine (µ g).

Selenium (µ g).

Molybdenum (µ g).

Chromium (µ g).

Fluor (mg).

ANNEX II

Vitamin and mineral substances that may be used in the manufacture of food supplements

A. Vitamins:

1. Vitamin A.

a) Retinol.

b) Retinyl acetate.

c) Retinyl Palmitate.

d) Beta-carotene.

2. Vitamin D.

a) Colecalciferol.

b) Ergocalciferol.

3. Vitamin E.

a) D-alpha tocopherol.

b) DL-alpha tocopherol.

c) D-alpha tocopheryl acetate.

d) DL-alpha tocopheryl acetate.

e) D-alpha tocopheryl acid succinate.

4. Vitamin K.

a) quinone (phytomenadione).

5. Vitamin C.

a) L-ascorbic acid.

b) L-sodium ascorbate.

c) calcium L-ascorbate.

d) potassium L-ascorbate.

e) 6-palmitate of L-ascorbilo.

6. Vitamin B1.

a) Thiamine hydrochloride.

b) thiamine mononitrate.

7. Vitamin B2.

a) Riboflavin.

b) Riboflavin-5 '-sodium phosphate.

8. Niacin.

a) Nicotinic acid.

b) Nicotinamide.

9. Vitamin B6.

a) Piridoxin hydrochloride.

b) Piridoxin 5-phosphate.

10. Folate.

a) Teroylmonoglutamic acid.

b) calcium L-methylfolate.

11. Vitamin B 12.

a) Cianocobalamin.

b) Hydroxicobalamin.

12. Biotin.

a) D-biotin.

13. Pantothenic acid.

a) calcium D-pantothenate.

b) D-pantothenate sodium.

c) Dexpantenol.

B. Mineral salts:

Sodium bicarbonate.

Sodium Carbonate.

Sodium Chloride.

Sodium citrate.

Sodium gluconate.

Sodium lactate.

Sodium Hydroxide.

Sodic salts of orthophosphoric acid.

Potassium bicarbonate.

Potassium carbonate.

Potassium chloride.

Potassium citrate.

Potassium gluconate.

Potassium glycerophosphate.

Potassium lactate.

Potassium hydroxide.

Orthophosphoric Acid Salts.

Calcium Carbonate.

Calcium chloride.

Citric acid calcium salts.

Calcium gluconate.

Calcium Glycerophosphate.

Calcium lactate.

Orthophosphoric Acid calcium salts.

Calcium hydroxide.

Calcium oxide.

Magnesium acetate.

Magnesium carbonate.

Magnesium chloride.

Magnesium salt of citric acid.

Magnesium gluconate.

Magnesium glycerophosphate.

Magnesium salt of orthophosphoric acid.

Magnesium lactate.

Magnesium hydroxide.

Magnesium oxide.

Magnesium sulfate.

Ferrous carbonate.

ferrous citrate.

Ferric ammonium citrate.

Ferrous gluconate.

Ferrous fumarate.

Ferric sodium diphosphate.

ferrous lactate.

Ferrous sulfate.

Ferric diphosphate (ferric pyrophosphate).

Ferric Saccharate.

Atomic iron (carbonyl + electrolytic + reduced hydrogen).

ferrous Bisglycinate.

Zinc Acetate.

Zinc chloride.

Zinc citrate.

Zinc gluconate.

Zinc lactate.

Zinc Oxide.

Zinc Carbonate.

Zinc Sulfate.

Manganese carbonate.

Manganese chloride.

manganese citrate.

Manganese gluconate.

Manganese glycerophosphate.

Manganese sulfate.

Cupric Carbonate.

Copric citrate.

Cupric Gluconate.

Cupric Sulfate.

Cobre-lysine complex.

Sodium iodide.

Sodium Yodato.

Potassium yoduro.

Potassium Yodatum.

Sodium seleniate.

Selenito sodium acid.

Selenito sodium.

Ammonium Molybdate [molybdenum (VI)].

Sodium molybdate [molybdenum (VI)].

Chromium Chloride (III).

Chromium Sulfate (III).

Potassium Fluoride.

Sodium Fluoride.