Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods

CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter and scope

This Regulation shall apply without prejudice to specific provisions laid down in Community legislation concerning:

(a) foods for particular nutritional uses and, in the absence of specific provisions, compositional requirements of such products rendered necessary by the particular nutritional requirements of the persons for whom they are intended;

(b) novel foods and novel food ingredients;

(c) genetically modified food;

(d) food additives and flavourings;

(e) authorised oenological practices and processes.

Article 2

Definitions

For the purposes of this Regulation:

(1) ‘Authority’ means the European Food Safety Authority established by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (¹);

(2) ‘other substance’ means a substance other than a vitamin or a mineral that has a nutritional or physiological effect.

CHAPTER II

ADDITION OF VITAMINS AND MINERALS

Article 3

Requirements for the addition of vitamins and minerals

Vitamins and minerals in a form that is bio-available to the human body may be added to foods, whether or not they are usually contained therein, in order to take into account, in particular:

(a) a deficiency of one or more vitamins and/or minerals in the population or specific population groups that can be demonstrated by clinical or sub-clinical evidence of deficiency or indicated by estimated low levels of intake of nutrients; or

(b) the potential to improve the nutritional status of the population or specific population groups and/or correct possible deficiencies in dietary intakes of vitamins or minerals due to changes in dietary habits; or

(c) evolving generally acceptable scientific knowledge on the role of vitamins and minerals in nutrition and consequent effects on health.

Modifications to the lists referred to in paragraph 1 of this Article shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3), taking account of the opinion of the Authority.

On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 14(4) in order to remove a vitamin or a mineral from the lists referred to in paragraph 1 of this Article.

Prior to making these modifications, the Commission shall carry out consultations with interested parties, in particular food business operators and consumer groups.

Article 4

Restrictions on the addition of vitamins and minerals

Vitamins and minerals may not be added to:

(a) unprocessed foodstuffs, including, but not limited to, fruit, vegetables, meat, poultry and fish;

(b) beverages containing more than 1,2 % by volume of alcohol, except and by way of derogation from Article 3(2), to products: (i) referred to in Article 44(6) and (13) of Council Regulation (EC) No 1493/1999 of 17 May 1999 on the common organisation of the market in wine (²); and (ii) which were marketed prior to the adoption of this Regulation; and (iii) which have been notified to the Commission by a Member State in accordance with Article 11, and provided that no nutrition or health claim is made.

Measures determining the additional foods or categories of foods to which particular vitamins and minerals may not be added and designed to amend non-essential elements of this Regulation may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3) in the light of scientific evidence and taking into account their nutritional value.

Article 5

Purity criteria

Article 6

Conditions for the addition of vitamins and minerals

The maximum amounts referred to in paragraph 1 and the conditions referred to in paragraph 2 shall be set taking into account:

(a) upper safe levels of vitamins and minerals established by scientific risk assessment based on generally acceptable scientific data, taking into account, as appropriate, the varying degrees of sensitivity of different groups of consumers; and

(b) intakes of vitamins and minerals from other dietary sources.

When the maximum amounts referred to in paragraph 1 and the conditions referred to in paragraph 2 are set for vitamins and minerals whose reference intakes for the population are close to the upper safe levels, the following shall also be taken into account, as necessary:

(a) the contribution of individual products to the overall diet of the population in general or of sub-groups of the population;

(b) the nutrient profile of the product established as provided for by Regulation (EC) No 1924/2006.

Article 7

Labelling, presentation and advertising

CHAPTER III

ADDITION OF CERTAIN OTHER SUBSTANCES

Article 8

Substances prohibited, restricted or under Community scrutiny

On its own initiative or on the basis of information provided by Member States, the Commission may take a decision designed to amend non-essential elements of this Regulation, following in each case an assessment of available information by the Authority, in accordance with the regulatory procedure with scrutiny referred to in Article 14(3), to include, if necessary, the substance or ingredient in Annex III. In particular:

(a) if a harmful effect on health has been identified, the substance and/or the ingredient containing the substance shall: (i) be placed in Annex III, Part A, and its addition to foods or its use in the manufacture of foods shall be prohibited; or (ii) be placed in Annex III, Part B, and its addition to foods or its use in the manufacture of foods shall only be allowed under the conditions specified therein;

(b) if the possibility of harmful effects on health is identified but scientific uncertainty persists, the substance shall be placed in Annex III, Part C.

On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 14(4) in order to include the substance or the ingredient in Annex III, Part A or B.

Within four years from the date a substance has been listed in Annex III, Part C, a decision designed to amend non-essential elements of this Regulation shall be taken in accordance with the regulatory procedure with scrutiny referred to in Article 14(3) and taking into account the opinion of the Authority on any files submitted for evaluation as mentioned in paragraph 4 of this Article, to generally allow the use of a substance listed in Annex III, Part C, or to list it in Annex III, Part A or B, as appropriate.

On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 14(4) in order to include the substance or the ingredient in Annex III, Part A or B.

CHAPTER IV

GENERAL AND FINAL PROVISIONS

Article 9

Community Register

The Register shall include the following:

(a) the vitamins and minerals which may be added to foods as listed in Annex I;

(b) the vitamin formulations and mineral substances which may be added to foods as listed in Annex II;

(c) the maximum and minimum amounts of vitamins and minerals which may be added to foods and any associated conditions set in accordance with Article 6;

(d) the information regarding national provisions on the mandatory addition of vitamins and minerals referred to in Article 11;

(e) any restrictions on the addition of vitamins and minerals as set out in Article 4;

(f) the substances for which dossiers have been submitted as provided for in Article 17(1)(b);

(g) information about the substances referred to in Annex III and the reasons for their inclusion therein;

(h) information about the substances listed in Annex III, Part C, whose use is generally allowed as referred to in Article 8(5).

Article 10

Free movement of goods

Without prejudice to the Treaty, in particular Articles 28 and 30 thereof, Member States may not restrict or forbid trade in foods which comply with this Regulation and Community acts adopted for its implementation by the application of non-harmonised national provisions governing the addition of vitamins and minerals to foods.

Article 11

National provisions

If a Member State, in the absence of Community provisions, considers it necessary to adopt new legislation:

(a) on the mandatory addition of vitamins and minerals to specified foods or categories of foods; or

(b) on the prohibition or restriction on the use of certain other substances in the manufacture of specified foods,

it shall notify the Commission in accordance with the procedure laid down in Article 12.

Article 12

Notification procedure

If the Commission's opinion is negative, it shall determine, in accordance with the procedure referred to in Article 14(2) and before the expiry of the period referred to in the first subparagraph of this paragraph, whether the envisaged measures may be implemented. The Commission may require certain amendments to be made to the envisaged measures.

Article 13

Safeguard measures

It shall immediately inform the other Member States and the Commission thereof and give reasons for its decision.

The Commission may initiate this procedure on its own initiative.

Article 14

Committee procedure

Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

Article 15

Monitoring

To facilitate efficient monitoring of foods to which vitamins and minerals have been added, and of foods containing substances listed in Annex III, Parts B and C, Member States may require the manufacturer or the person placing such foods on the market in their territory to notify the competent authority of that placing on the market by providing a model of the label used for the product. In such cases, information on the withdrawal of the product from the market may also be required.

Article 16

Evaluation

By 1 July 2013, the Commission shall submit to the European Parliament and the Council a report on the effects of implementing this Regulation, in particular concerning the evolution of the market in foods to which vitamins and minerals have been added, their consumption, nutrient intakes for the population and changes in dietary habits, and the addition of certain other substances, accompanied by any proposals for amendment of this Regulation which the Commission deems necessary. In this context Member States shall provide the necessary relevant information to the Commission by 1 July 2012. Rules for implementing this Article shall be specified in accordance with the procedure referred to in Article 14(2).

Article 17

Transitional measures

By way of derogation from Article 3(1) and until 19 January 2014, Member States may allow in their territory the use of vitamins and minerals not listed in Annex I, or in forms not listed in Annex II, provided that:

(a) the substance in question is used for addition to foods marketed in the Community on 19 January 2007; and

(b) the Authority has not given an unfavourable opinion in respect of the use of that substance, or its use in that form, in the manufacture of food, on the basis of a dossier supporting use of the substance in question to be submitted to the Commission by the Member State not later than 19 January 2010.

Article 18

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 1 July 2007.

Foods placed on the market or labelled prior to 1 July 2007 which do not comply with this Regulation may be marketed until their expiry date, but not later than 31 December 2009.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX I

1. Vitamins

Vitamin A

Vitamin D

Vitamin E

Vitamin K

Vitamin B1

Vitamin B2

Niacin

Pantothenic acid

Vitamin B6

Folic acid

Vitamin B12

Biotin

Vitamin C

2. Minerals

Calcium

Magnesium

Iron

Copper

Iodine

Zinc

Manganese

Sodium

Potassium

Selenium

Chromium

Molybdenum

Fluoride

Chloride

Phosphorus

Boron

ANNEX II

Vitamin formulations and mineral substances which may be added to foods

1. Vitamin formulations

retinol

retinyl acetate

retinyl palmitate

beta-carotene

cholecalciferol

ergocalciferol

D-alpha-tocopherol

DL-alpha-tocopherol

D-alpha-tocopheryl acetate

DL-alpha-tocopheryl acetate

D-alpha-tocopheryl acid succinate

phylloquinone (phytomenadione)

menaquinone (^*1)

thiamin hydrochloride

thiamin mononitrate

riboflavin

riboflavin 5′-phosphate, sodium

nicotinic acid

nicotinamide

nicotinamide riboside chloride

D-pantothenate, calcium

D-pantothenate, sodium

dexpanthenol

pyridoxine hydrochloride

pyridoxine 5′-phosphate

pyridoxine dipalmitate

pteroylmonoglutamic acid

calcium-L-methylfolate

monosodium salt of L-5-methyltetrahydrofolic acid (^*2)

cyanocobalamin

hydroxocobalamin

D-biotin

L-ascorbic acid

sodium-L-ascorbate

calcium-L-ascorbate

potassium-L-ascorbate

L-ascorbyl 6-palmitate

2. Mineral substances

calcium carbonate

calcium chloride

calcium citrate malate

calcium salts of citric acid

calcium gluconate

calcium glycerophosphate

calcium lactate

calcium salts of orthophosphoric acid

calcium hydroxide

calcium malate

calcium oxide

calcium sulphate

calcium phosphoryl oligosaccharides

magnesium acetate

magnesium carbonate

magnesium chloride

magnesium salts of citric acid

magnesium gluconate

magnesium glycerophosphate

magnesium salts of orthophosphoric acid

magnesium lactate

magnesium hydroxide

magnesium oxide

magnesium potassium citrate

magnesium sulphate

ferrous bisglycinate

ferrous carbonate

ferrous citrate

ferric ammonium citrate

ferrous gluconate

ferrous fumarate

ferric sodium diphosphate

ferrous lactate

ferrous sulphate

ferrous ammonium phosphate

ferric sodium EDTA

ferric diphosphate (ferric pyrophosphate)

ferric saccharate

elemental iron (carbonyl + electrolytic + hydrogen reduced)

iron milk caseinate (⁴)

cupric carbonate

cupric citrate

cupric gluconate

cupric sulphate

copper lysine complex

sodium iodide

sodium iodate

potassium iodide

potassium iodate

zinc acetate

zinc bisglycinate

zinc chloride

zinc citrate

zinc gluconate

zinc lactate

zinc oxide

zinc carbonate

zinc sulphate

manganese carbonate

manganese chloride

manganese citrate

manganese gluconate

manganese glycerophosphate

manganese sulphate

sodium bicarbonate

sodium carbonate

sodium citrate

sodium gluconate

sodium lactate

sodium hydroxide

sodium salts of orthophosphoric acid

selenium enriched yeast (^*3)

sodium selenate

sodium hydrogen selenite

sodium selenite

sodium fluoride

potassium fluoride

potassium bicarbonate

potassium carbonate

potassium chloride

potassium citrate

potassium gluconate

potassium glycerophosphate

potassium lactate

potassium hydroxide

potassium salts of orthophosphoric acid

chromium (III) chloride and its hexahydrate

chromium (III) sulphate and its hexahydrate

chromium picolinate

chromium(III) lactate tri-hydrate

ammonium molybdate (molybdenum (VI))

sodium molybdate (molybdenum (VI))

boric acid

sodium borate

ANNEX III

Part A — Prohibited substances

Aloe-emodin and all preparations in which this substance is present

Danthron and all preparations in which this substance is present

Emodin and all preparations in which this substance is present

Ephedra herb and its preparations originating from Ephedra species

Preparations from the leaf of Aloe species containing hydroxyanthracene derivatives

Yohimbe bark and its preparations originating from Yohimbe (Pausinystalia yohimbe (K. Schum) Pierre ex Beille)

PART B

Restricted substances