There is a growing number of products in the European Union marketed as food containing concentrated sources of nutrients, which are presented in order to supplement the intake of such nutrients in the European Union. the normal diet.

In normal circumstances, a proper, balanced diet provides all the nutrients necessary for the normal development and maintenance of a healthy organism. However, research has shown that this ideal situation is not given in practice for all nutrients, nor for all population groups.

Because of ways of life or for other reasons, consumers may decide to increase the intake of some nutrients through food supplements.

In order to ensure a high level of consumer protection and to make it easier for consumers to choose, products placed on the market should not be in danger and their labels should be adequate and sufficient to facilitate the information to the consumer.

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.

On the other hand, there is currently a wide range of vitamin preparations and mineral substances, which are being marketed in some Member States, under the name of food supplements, which are not yet available. have been evaluated by the Scientific Committee for Food and are therefore not included in the positive lists. It is necessary for these preparations and substances to be submitted urgently to the European Food Safety Authority for evaluation, as soon as the relevant dossiers are submitted by the interested parties.

It is essential that chemical substances used as sources of vitamins and minerals in the manufacture of food supplements not only present no danger, but also that they are available to the body. It is therefore appropriate to establish 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 above criteria for use in the manufacture of foodstuffs. food intended for infants and young children, and other foods for particular nutritional uses.

In this royal decree the specific rules for vitamins and minerals used as ingredients in food supplements are established.

At a later stage, provided that adequate scientific data are available and have not been regulated at European Union level, specific rules concerning the remaining nutrients or other substances may be adopted. a nutritional or physiological effect used as ingredients in food supplements.

Taking into account that consumers may decide to supplement their nutrient intake by consuming these products, and considering that excessive and continued intake of these products may have detrimental effects on the the health, it is necessary to set maximum levels, to ensure that the normal use of these products in accordance with the instructions for use given by the manufacturer presents no danger to consumers.

As soon as maximum levels of nutrients or other substances with a nutritional or physiological effect are set in the European Union for food supplements, the Committee's reports shall be taken into account. Scientist of the Human Food and of the international organizations of recognized scientific solvency.

Also, to ensure that these products allow the purpose of supplementing the intake of these vitamins and minerals in the usual diet, the content of such substances must be found in quantities. significant.

In order to facilitate better control of these products at a possible risk of adverse effects not foreseeable at the present time in accordance with scientific knowledge, their placing on the market should be notified. National market.

The regulation of this type of products varies from one Member State to another. These differences in classification in the European Union have led to problems in their free movement, which is why the European Parliament and the Council have adopted Directive 2002/46/EC of 10 June 2002 on supplements food, which is incorporated into the internal legal order by means of this royal decree.

This royal decree is dictated by the provisions of Article 149.1.13.a and 16.a of the Constitution, and in accordance with the provisions of Articles 38, 40.2 and 40.4 of Law 14/1986 of 25 April, General of Health.

the Autonomous Communities, as well as the sectors affected, have been consulted, and the Inter-Ministerial Commission for Food Management has issued its mandatory report.

By virtue of the proposal of the Minister for Health and Consumer Affairs and the Minister for Agriculture, Fisheries and Food, in agreement with the Council of State and after deliberation by the Council of Ministers at its meeting on 10 October of 2003,

D I S P O N G O:

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 shall be delivered to the final consumer only pre-packaged.

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:

(a) Food for ordinary consumption, which shall be in accordance with the relevant technical-health regulations or quality standards.

(b) Food preparations for a special diet regulated by Royal Decree 2685/1976 of 16 October 1976 on the technical and health regulations for the production, circulation and trade of goods food preparations for dietetic and/or special schemes and their subsequent modifications, as well as the dietetic products listed in their Annex and which are regulated by specific rules.

(c) The medicinal products covered by Law 25/1990 of 20 December of the Medicamento, as well as the different rules governing those products.

Article 2. Definitions.

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

(a) Food supplements: foodstuffs intended to supplement the normal diet and consisting of concentrated sources of nutrients or other substances having a nutritional or physiological effect, in the form of simple or combined, marketed in such a way as to permit a particular dosage of the product and to be taken in small unit quantities.

b) Nutrients: vitamins and minerals.

Article 3. Ingredients and criteria of purity.

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 shall be applied in

the manufacture of food products for purposes other than those provided for in this royal 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.

4. The aromatic substances used in the manufacture of these products will comply with the provisions of Royal Decree 1477/1990 of 2 November 1990 on the technical-health regulation of flavourings used in products food and the basic materials for their production.

5. In the preparation of products falling within the scope of this royal decree, only those additives which are expressly authorised by the provisions of their various categories and their conditions of use may be used. use for the various foodstuffs in which they are included.

Article 4. Presentation of the products to the final consumer.

The products referred to in this provision may be marketed in the following ways:

capsules, tablets, tablets, pills and grasses, granules, seals, sachets, beibble blisters, dropper bottles and other similar forms of liquids and powders, provided that they allow a particular dosage of the product.

The bulk sale or its split sale is not permitted.

Article 5. Conditions of the industries.

Given the characteristics and forms of presentation of these products, the processing and packaging industries of these products will have to comply with the provisions of Royal Decree 2207/1995 of 28 November on relative hygiene standards. to food products.

Article 6. 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 the products. food products.

2. For the purposes of applying Article 6 (1) of Royal Decree 1334/1999 of 31 July 1999, 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. Labelling, presentation and advertising shall not give food supplements the property of preventing, treating or curing a human disease, nor shall they 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 name of the categories of nutrients or substances that characterise the product, or an indication of the nature of such nutrients or substances.

b) The dose of the recommended product for daily consumption.

c) The warning not to exceed the daily dose expressly recommended.

d) The 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 children.

Article 7. Specific labelling.

1. The quantity 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.

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

3. The information on the nutrients containing the products covered by this standard shall also be expressed as a percentage of the reference values referred to in Annex III.

4. The percentage of the reference values for the abovementioned nutrients may also be shown in graphic form.

Article 8. Average values.

The declared values referred to in Article 7 (1) and (2) shall be average values based on the manufacturer's analysis of the product.

Article 9. Administrative records.

The companies responsible for the production, processing, packaging, storage, distribution, import and marketing of the products regulated by this royal decree must be registered in the General Health Register of food, regulated by Royal Decree 1712/1991 of 29 November on General Health Registration of Food.

Article 10. Information on the marketing of products.

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 domestic market, or the importer, in the case of third countries.

2. For the purposes of the above paragraph:

(a) The notification of the placing on the domestic market of food supplements, of domestic production or from 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

the first

placing on that market. The autonomous communities shall notify the Spanish Food Safety Agency of the notifications they receive.

(b) notifications of food supplements shall be submitted to the Spanish Food Safety Agency, directly or through the peripheral services, when, even if they are from countries belonging to the Union European, the person responsible does not have established his registered office in Spain, or when they come from third countries outside the European Union.

(c) The Spanish Food Safety Agency shall provide the necessary mechanisms for access by the Ministry of Agriculture, Fisheries and Food to the notifications of the placing on the national market of the supplements. food to be received by the agency as provided for in paragraphs (a) and (b).

Article 11. Precautionary measures.

If the Spanish Food Safety Agency, based on a detailed statement of reasons for the existence of new data or a new assessment of existing data, considers that the use of a food supplement puts into In spite of its compliance with the provisions in question, human health may temporarily suspend or limit the application of those provisions within the national territory, and shall immediately inform the European Commission and the other Member States, specifying the reasons for their decision.

Article 12. Sanctioning regime.

Without prejudice to other rules that may be applicable, the infringements committed against the provisions of this royal decree will be subject to administrative sanctions, subject to the appropriate procedure. In accordance with the provisions of Chapter VI of Title I of Law 14/1986 of 25 April 1986, General of Health, and Royal Decree 1945/1983 of 22 June 1983 on the protection of the environment and the protection of the environment, the Council of the European Union consumer and agri-food production.

Additional disposition first. Administrative regulation of products placed on the market.

The companies responsible for those products which, at the time of the entry into force of this provision, are being marketed under other regulations and which intend to continue such marketing within the scope of this royal decree shall communicate it to the competent authority in accordance with the terms laid down in Article 10.

Additional provision second. Recommended daily quantity.

For the purposes of this regulation, the recommended daily amount (CDR) is the amount of a nutrient that a healthy person should ingest on average every day, through the diet, to maintain good health.

As long as the European Commission does not set specific values for the maximum and minimum levels of nutrients contained in food supplements, for the purposes of this royal decree the recommended daily quantity (CDR) will be considered. set out in the Annex to Royal Decree 930/1992 of 17 July on the adoption of the labelling standard on nutritional properties of foodstuffs and set out in Annex III to this royal decree.

For products containing the nutrients listed in Annex I to this royal decree, alone or in combination, the content of these products shall be such that the daily intake recommended by the manufacturer on the labelling does not provide a less than 15% or more than 100% of the CDR.

Additional provision third. Specific sanctioning regime.

The failure to comply with Article 4.1 (b), (c) and (d), as well as in paragraph (a) of Article 4.1, is considered to be a serious misconduct when it carries a risk to public health, of Royal Decree 1334/1999, of On 31 July, the General Standard for the labelling, presentation and advertising of foodstuffs was adopted, in accordance with the provisions of Article 35 (B) (1) of Law 14/1986 of 25 April 1986, General Health. Also under the same legal provision, the failure to comply with Article 6 (3), (4) and (5) and the omission of the notification provided for in Article 10 of this royal decree is considered to be serious.

First transient disposition. Time limit for marketing.

The food products referred to in this royal decree that do not conform to the established, but which comply with the regulations in force at the date of entry into force, may be marketed until 31 December. of July 2005.

Second transient disposition. Extension of marketing.

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) The substance concerned is 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 on the use of that substance or its use in that 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.

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.

The provisions of this royal decree, which will be applicable throughout the national territory, are dictated by the provisions of Article 149.1.13.a and 16.a of the Spanish Constitution and by virtue of the provisions of the articles of 38, 40.2 and 40.4 of Law 14/1986, of 25 April, General of Health.

Final disposition third. Faculty of development.

The Ministers of Health and Consumer Affairs and Agriculture, Fisheries and Food are empowered to jointly adopt the necessary measures for the development and implementation of this royal decree and, in particular, to modify or update the its annexes to be adapted to 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 fourth. Entry into force.

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

Given in Madrid, 10 October 2003.

JOHN CARLOS R.

Deputy Prime Minister of the Government and Minister of the Presidency, JAVIER ARENAS BOCANEGRA

ANNEX I

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

1. Vitamins:

Vitamin A (mg RE).

Vitamin D (mg).

Vitamin E (mg -TE).

Vitamin K (mg).

Vitamin C (mg).

Vitamin B1 (mg).

Vitamin B2 (mg).

Niacin (mg NE).

Vitamin B6 (mg).

Folic acid (mg).

Vitamin B12 (mg).

Biotin (mg).

Pantothenic acid (mg).

2. Minerals:

Sodium (mg).

Chlorine (mg).

Potassium (mg).

Calcium (mg).

Phosphorus (mg).

Magnesium (mg).

Iron (mg).

Zinc (mg).

Manganese (mg).

Copper (mg).

Iodine (mg).

Selenium (mg).

Molybdenum (mg).

Chromium (mg).

Fluor (mg).

ANNEX II

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

A. Vitamin substances

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:

quinone (phytomenadione).

5. Vitamin C:

a) L-ascorbic acid.

b) sodium L-ascorbate.

c) calcium ascorbate.

d) potassium ascorbate.

e) -L-ascorbilo-palmitate.

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) Pyridoxin 5-phosphate.

10. Folic acid:

Teroylmonoglutamic acid.

11. Vitamin B12:

a) Cianocobalamin.

b) Hydroxicobalamin.

12. Biotin:

D-biotin.

13. Pantothenic acid:

a) calcium D-pantothenate.

b) D-pantothenate sodium.

c) Dexpanthenol.

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.

Potassium salts of orthophosphoric acid.

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 Ggluconate.

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).

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.

Cuprico citrate.

Cupric Gluconate.

Cupric Sulfate.

Cobre-lysine complex.

Sodium iodide.

Sodium Yodate.

Potassium yoduro.

Potassium yodato.

Seleniate sodium.

Selenito sodium acid.

Selenito sodium.

Ammonium Molybdate [molybdenum (VI)].

Sodium molybdate [molybdenum (VI)].

Chromium chloride (III).

Chromium Sulfate (III).

Potassium Fluoride.

Sodium Fluoride.

ANNEX III

(VIEW IMAGE, PAGE 26784)

For the purposes of this royal decree, the recommended daily amounts (CDR) of nutrients are as follows:

1. Vitamins

Vitamin A (Retinol) mg ................................ 800 Vitamin D (Ergocalciferol or colecalciferol) mg .. 5 Vitamin E (Tocoferol) mg ............................ 10 Vitamin K (mg) .......................................... Set Vitamin C (Ascorbic acid) mg ................... 60 Vitamin B1 (Tiamine) mg ............................ 1.4 Vitamin B2 (Rivoflavin) mg ........................ 1.6 Vitamin B3 (Niacin) mg ............................. Vitamin B6 (pyridoxine or pyridoxamine) mg ............................................... 2 Vitamin B9 (folic acid or folates) mg ............ 200 Vitamin B12 (Cianocobalamin) mg ............... 1 Biotin mg ................................................ 0.15 Pantothenic acid mg ................................. 6

2. Minerals

Sodium mg .................................................. to fix Cloro mg ................................................... to fix Potasio mg ................................................ to fix Calcio mg ................................................. 800 Fosforum mg ................................................ 800 Magnesium mg ............................................ 300 Iron mg ................................................. 14 Zinc mg .................................................... 15 Manganese mg .......................................... to fix Copper mg ................................................... to fix iodine mg .................................................... 150 Selenium mg ................................................. to fix molybdenum mg ............................................ to fix Chromo mg .................................................. to fix Fluor mg ................................................... to fix