Text proposed by the Commission ⁽¹⁾

Amendments by Parliament

(6)  There is a wide range of nutrients and other ingredients that might be present in food supplements including, but not limited to, vitamins, minerals, amino acids, essential fatty acids, fibre and various plant and herbal extracts. However, as a first stage, this Directive should only cover food supplements containing vitamins and minerals.

(6)  There is a wide range of nutrients and other ingredients that might be present in food supplements including, but not limited to, vitamins, minerals, amino acids, fatty acids, fibre and various plant and herbal extracts. However, as a first stage, this Directive should only cover food supplements containing vitamins and minerals. Food supplements containing substances other than those covered by this Directive should be subject to national provisions. Specific rules concerning other nutrients or other substances used as ingredients in food supplements should be laid down as soon as adequate and appropriate scientific data is available. Products which contain both vitamins and/or minerals and other ingredients should be subject to this Directive only in respect of their vitamin and mineral content.

(6a) There is a wide range of nutrients and other ingredients contained in food supplements currently marketed in the Member States which have not yet been evaluated according to the procedure referred to in Article 13(2) and which are therefore not yet included in Annex II. The Commission should submit these substances to the Scientific Committee for Food (SCF) as soon as the appropriate documents are submitted by the interested parties. The Commission should ensure that evaluations are completed on these substances as a matter of urgency.

(7)  Only vitamins and minerals normally found in and consumed as part of the diet and considered essential nutrients should be allowed to be present in food supplements although this does not mean that their presence therein is necessary. Controversy as to the identity of those essential nutrients that could potentially arise should be avoided. Therefore it is appropriate to establish a positive list of those vitamins and minerals.

(7)  Only vitamins and minerals normally found in and consumed as part of the diet should be allowed to be present in food supplements although this does not mean that their presence therein is necessary. Controversy as to the identity of nutrients that could potentially arise should be avoided. Therefore it is appropriate to establish a positive list of those vitamins and minerals.

(9)  In order to keep up with scientific and technological developments it is important to revise the lists promptly, when necessary. Such revisions would be implementing measures of a technical nature and their adoption should be entrusted to the Commission in order to simplify and expedite the procedure.

(9)  In order to keep up with scientific and technological developments it is important to revise the lists promptly, when necessary. Such revisions would be implementing measures of a technical nature and their adoption, in this case on the manufacturer's request to the Commission, after consultation of the relevant committees, should be entrusted to the Commission in order to simplify and expedite the procedure .

(14)  General labelling provisions and definitions are contained in Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer(¹), as last amended by Directive 97/4/EC of the European Parliament and of the Council(²), and do not need to be repeated. This Directive can therefore be confined to the necessary additional provisions.

(14)  General labelling provisions and definitions are contained in European Parliament and Council Directive 2000/13/EC of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs⁽¹⁾, and do not need to be repeated. This Directive should therefore be confined to the necessary additional provisions.

(¹) OJ L 33, 8.2.1979, p. 1.

(²) OJ L 43, 14.2.1997, p. 21.

(¹) OJ L 109, 6.5.2000, p. 29.

(16a) Some Member States do not have regulations concerning food supplements. Member States may allow more products on their markets than those that comply with this Directive. Producers wishing to market products that do not comply with this Directive in another Member State should submit their ingredients to the testing procedures set out in this Directive.

(a)  "food supplements" means foodstuffs that are concentrated sources of nutrients as specified in (b), alone or in combination, marketed in dose form, whose purpose is to supplement the intake of those nutrients in the normal diet;

(a)  "food supplements" means foodstuffs that are concentrated sources of nutrients or other substances with a nutritional or physiological function, alone or in combination, marketed in dose form, whose purpose is to supplement the intake of those nutrients in the normal diet;

(iia)  other ingredients with a nutritional or physiological function which, in accordance with Article 4(3a), are included in Annex I;

(c)  "dose form" means forms such as capsules, tablets, pills and other similar forms, sachets of powder, ampoules of liquids and drop dispensing bottles.

(c)  "dose form" means forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids and drop dispensing bottles, liquid and powder preparations administered with a measuring spoon or beaker and other similar forms of measured quantity.

Member States shall ensure that the food supplements containing the nutrients listed in Article 2(b) may be marketed within the Community only if they comply with the rules laid down in this Directive.

1.  Member States shall ensure that the food supplements containing the nutrients listed in Article 2(b) may be marketed within the Community only if they comply with the rules laid down in this Directive.

2.  Food supplements listed in paragraph 1, and which do not comply with the Directive, and which may contain substances other than those covered by this Directive, shall be subject to national provisions. Products which contain both vitamins and/or minerals and other ingredients shall be subject to this Directive only in respect of their vitamin and mineral content.

2.  The criteria of purity for the substances, referred to in paragraph 1 shall be adopted in accordance with the procedure referred to in Article 13(2).

2.  The criteria of purity for the substances, referred to in paragraph 1 shall be adopted in accordance with the procedure referred to in Article 13(2). They must as a minimum be based on general principles of hygiene and good manufacturing practice.

3.  Modifications to the lists referred to in paragraph 1 shall be adopted in accordance with the procedure referred to in Article 13 (2).

3.  A specific procedure for the evaluation of the safety of substances referred to in paragraph 1 shall be adopted in accordance with the procedure referred to in Article 13 (2). This procedure shall be subject to the principle of transparency and shall afford the parties concerned the opportunity to provide further data prior to the adoption of the final opinion of the Scientific Committee for Food.

3a. The European Parliament and the Council shall decide as soon as the necessary scientific data is available, and without prejudice to the competence of the Commission, on the inclusion of other ingredients with a nutritional or physiological function within the scope of this Directive with a view to further pursuing the goals of this Directive.

(3b) The Commission shall ensure that nutrients and ingredients contained in food supplements marketed in the Community prior to the date of adoption of this Directive and listed in Part B of Annex II, but not covered by this Directive, undergo scientific evaluation as soon as the necessary documents are submitted to the Commission by the parties concerned. Those ingredients that are approved in accordance with the procedure in Article 13(2) shall then be transferred from Part B to Part A of Annex II.

(ca)  the requirements of children and adults respectively.

3.  The maximum and minimum amounts of vitamins and minerals referred to in paragraphs 1 and 2 shall be adopted in accordance with the procedure referred to in Article 13 (2).

3.  The maximum and minimum amounts of vitamins and minerals referred to in paragraphs 1 and 2 shall be adopted in accordance with the procedure referred to in Article 13 (2). This procedure shall be subject to the principle of transparency.

1.  The name under which products covered by this Directive are sold shall include the word "supplement" and the name of the category of the nutrient(s) characterising the product. The name of the category of the nutrient(s) may be completed or replaced by the specific name of the nutrient(s) characterising the product.

1.  The labelling of products covered by this Directive shall include the words "food supplement" and the name of the category of the nutrient(s) characterising the product and/or the ingredient(s) characterising the product. The name of the category of the nutrient(s) may be completed or replaced by the specific name of the nutrient(s) and/or of the ingredient(s) characterising the product.

(b)  a warning as to the possible health risks, as the case may be, in exceeding the recommended portion for daily consumption;

(b)  a statement that the recommended portion for daily consumption should not be exceeded. If there are health risks should the amount be exceeded this must be explained on the package leaflet. If there is no leaflet the statement must appear on the product;

(c)  a statement to the effect that food supplements should not be used as a substitute for a diversified diet.

Deleted

(ca)  a statement to the effect that the products should be stored out of the reach of children;

(cb)  a statement that the product may be taken by pregnant women or children under the age of one only after the agreement of a doctor or health visitor.

4.  When the form of presentation is similar to a pharmaceutical form as defined by pharmacopoeias, the statement  "This is not a medicinal product"  shall appear on the label.

Deleted

The labelling of food supplements shall not include any mention stating or implying that an adequate and diversified diet cannot provide appropriate quantities of nutrients.

The labelling of food supplements shall not include any mention stating or implying that an adequate and diversified diet cannot provide appropriate quantities of nutrients, if not scientifically proved otherwise.

The rules for implementing this paragraph with regard in particular to the differences between the declared values and those established in the course of official checks shall be decided upon in accordance with the procedure referred to in Article 13(2).

The rules for implementing this paragraph with regard in particular to the differences between the declared values and those established in the course of official checks shall be decided upon in accordance with the procedure referred to in Article 13(2). Excess doses which could harm the consumer must be avoided. For substances where there are no stability problems, the specified weighed portion shall be adequate within a 10% tolerance limit.

2a. Food supplements shall be produced according to good manufacturing practice, to be decided upon in accordance with the procedure referred to in Article 13(2).

Member States may not impose this requirement, if they can demonstrate to the Commission that notification is not necessary in order to monitor those products efficiently in their territory.

Deleted

2.  The Commission shall examine as soon as possible the grounds adduced by the Member State concerned and shall consult the Member States within the Standing Committee for Foodstuffs, and shall then deliver its opinion without delay and take appropriate measures.

2.  The Commission shall examine within three months the grounds adduced by the Member State concerned and shall consult the Member States within the Standing Committee for Foodstuffs, and shall then deliver its opinion without delay and take appropriate measures within one month of that consultation.

The Committee shall lay down and publish guidelines concerning the criteria, the procedure, and the timetable it shall adopt in assessing substances. It shall be open and transparent in its communications with applicants.

1.  Vitamins

Vitamin A (g RE)

Vitamin D (g)

Vitamin E (mg -TE)

Vitamin K (g)

Vitamin B1 (mg)

Vitamin B2 (mg)

Niacin (mg NE)

Pantothenic acid (mg)

Vitamin B6 (g)

Folic acid (g)

Vitamin B12 (g)

Biotin (g)

Vitamin C (mg)

1.  Vitamins

Vitamin A (g RE or IU)

Vitamin D (g or IU)

Vitamin E (mg -TE)

Vitamin K (g)

Vitamin B1 (mg)

Vitamin B2 (mg)

Niacin (mg NE)

Pantothenic acid (mg)

Vitamin B6 (mg)

Folic acid (g)

Vitamin B12 (g)

Biotin (g)

Vitamin C (mg)

2.  Minerals

Calcium (mg)

Magnesium (mg)

Iron (mg)

Copper (µg)

Iodine (µg)

Zinc (mg)

Manganese (mg)

Sodium (mg)

Potassium (mg)

Selenium (µg)

Chromium (µg)

Molybdenum (µg)

Fluoride (mg)

Chloride (mg)

Phosphorus (mg)

2.  Minerals

Calcium (mg)

Magnesium (mg)

Iron (mg)

Copper (µg or mg)

Iodine (µg)

Zinc (mg)

Manganese (mg)

Sodium (mg)

Potassium (mg)

Selenium (µg)

Chromium (µg)

Molybdenum (µg)

Fluoride (mg)

Chloride (mg)

Phosphorus (mg)

Boron (µg or mg)

Nickel (µg or mg)

Silicon (µg or mg)

Vanadium (µg or mg)

Tin (µg or mg)

B.  Vitamin and Mineral substances marketed in the EU which should undergo scientific evaluation

1.  Vitamins

VITAMIN A

-  carotenoids

VITAMIN D

-  cholecalciferol-cholesterin

VITAMIN B1

-  thiamine monophosphate

VITAMIN C

-  magnesium ascorbate

2.  Minerals

boron amino acid chelate

sodium borate

calcium phosphate

dicalcium phosphate

calcium pidolate

calcium amino acid chelate dolomite

chromium amino acid chelate

chromium picolinate

chromium polynicotinate

magnesium pidolate

magnesium amino acid chelate

iron oxide

iron amino acid chelate

copper amino acid chelate

copper oxide

tin chloride

nickel sulphate

nickel sulphide

stannous chloride

zinc stearate

zinc yeast

zinc amino acid chelate

manganese pidolate

potassium orotate

potassium iodide

potassium iodate

potassium sulphate

potassium amino acid chelate

potassium aspartate

magnesium orotate

molybdenum amino acid chelate

sodium caseinate

selenium yeast

selenomethionine

chromium chelate

chromium (III) oxide

chromium (III) nitrate

boron chelate

sodium metasilicate

sodium molybdate

silicon dioxide

sodium metavanadate

colloidal silica

orthosilicic acid

selenium lacto-bacillus

vanadium amino acid chelate

vanadyl sulphate

zinc amino acid chelate

zinc picolinate