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Document 02006R1925-20230622
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
Consolidated text: 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
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
02006R1925 — EN — 22.06.2023 — 012.001
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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 (OJ L 404 30.12.2006, p. 26) |
Amended by:
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REGULATION (EC) No 108/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 January 2008 |
L 39 |
11 |
13.2.2008 |
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L 314 |
36 |
1.12.2009 |
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L 296 |
29 |
15.11.2011 |
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REGULATION (EU) No 1169/2011 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2011 |
L 304 |
18 |
22.11.2011 |
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L 39 |
44 |
8.2.2014 |
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L 67 |
4 |
12.3.2015 |
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L 173 |
9 |
6.7.2017 |
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L 110 |
17 |
25.4.2019 |
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L 110 |
21 |
25.4.2019 |
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L 96 |
6 |
19.3.2021 |
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L 151 |
37 |
2.6.2022 |
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L 310 |
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1.12.2022 |
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L 143 |
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2.6.2023 |
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:
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;
novel foods and novel food ingredients;
genetically modified food;
food additives and flavourings;
authorised oenological practices and processes.
Article 2
Definitions
For the purposes of this Regulation:
‘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 );
‘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 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
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
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:
unprocessed foodstuffs, including, but not limited to, fruit, vegetables, meat, poultry and fish;
beverages containing more than 1,2 % by volume of alcohol, except and by way of derogation from Article 3(2), to products:
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
which were marketed prior to the adoption of this Regulation; and
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:
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
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:
the contribution of individual products to the overall diet of the population in general or of sub-groups of the population;
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:
if a harmful effect on health has been identified, the substance and/or the ingredient containing the substance shall:
be placed in Annex III, Part A, and its addition to foods or its use in the manufacture of foods shall be prohibited; or
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;
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:
the vitamins and minerals which may be added to foods as listed in Annex I;
the vitamin formulations and mineral substances which may be added to foods as listed in Annex II;
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;
the information regarding national provisions on the mandatory addition of vitamins and minerals referred to in Article 11;
any restrictions on the addition of vitamins and minerals as set out in Article 4;
the substances for which dossiers have been submitted as provided for in Article 17(1)(b);
information about the substances referred to in Annex III and the reasons for their inclusion therein;
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:
on the mandatory addition of vitamins and minerals to specified foods or categories of foods; or
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:
the substance in question is used for addition to foods marketed in the Community on 19 January 2007; and
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
VITAMINS AND MINERALS WHICH MAY BE ADDED TO FOODS
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
VITAMIN A
retinol
retinyl acetate
retinyl palmitate
beta-carotene
VITAMIN D
cholecalciferol
ergocalciferol
VITAMIN E
D-alpha-tocopherol
DL-alpha-tocopherol
D-alpha-tocopheryl acetate
DL-alpha-tocopheryl acetate
D-alpha-tocopheryl acid succinate
VITAMIN K
phylloquinone (phytomenadione)
menaquinone ( *1 )
VITAMIN B1
thiamin hydrochloride
thiamin mononitrate
VITAMIN B2
riboflavin
riboflavin 5′-phosphate, sodium
NIACIN
nicotinic acid
nicotinamide
nicotinamide riboside chloride
PANTOTHENIC ACID
D-pantothenate, calcium
D-pantothenate, sodium
dexpanthenol
VITAMIN B6
pyridoxine hydrochloride
pyridoxine 5′-phosphate
pyridoxine dipalmitate
FOLIC ACID
pteroylmonoglutamic acid
calcium-L-methylfolate
VITAMIN B12
cyanocobalamin
hydroxocobalamin
BIOTIN
D-biotin
VITAMIN C
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)
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 ( *2 )
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
SUBSTANCES WHOSE USE IN FOODS IS PROHIBITED, RESTRICTED OR UNDER COMMUNITY SCRUTINY
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
Restricted substance |
Conditions of use |
Additional requirements |
Green tea extracts containing (-)- epigallocatechin-3-gallate (1) |
Daily portion of food shall contain less than 800 mg of (-)-epigallocatechin-3-gallate |
The label shall provide the maximum number of portions of the food for daily consumption and a warning not to consume a daily amount of 800 mg of (-)-epigallocatechin-3-gallate or more. The label shall indicate the content of (-)- epigallocatechin-3-gallate per portion of the food. The label shall include the following warnings: ‘Should not be consumed if you are consuming other products containing green tea on the same day’. ‘Should not be consumed by pregnant or lactating women and children below 18 years old’. ‘Should not be consumed on an empty stomach’ |
Monacolins from red yeast rice |
Individual portion of the product for daily consumption shall provide less than 3 mg of monacolins from red yeast rice. |
The label shall provide the number of individual portions of the product for maximum daily consumption and a warning not to consume a daily amount of 3 mg of monacolins from red yeast rice or more. The label shall indicate the content of monacolins per portion of the product. The label shall include the following warnings: ‘Should not be consumed by pregnant or lactating women, children below 18 years old and adults above 70 years old’. ‘Seek advice from a doctor on consumption of this product if you experience any health problems’; ‘Should not be consumed if you are taking cholesterol-lowering medication’; ‘Should not be consumed if you are already consuming other products containing red yeast rice’. |
Trans fat other than trans fat naturally occurring in fat of animal origin |
Maximum 2 grams per 100 grams of fat in food intended for the final consumer and food intended for supply to retail |
Food business operators supplying other food business operators with food not intended for the final consumer or not intended for supply to retail, shall ensure that supplied food business operators are provided with information on the amount of trans fat, other than trans fat naturally occurring in fat of animal origin, where that amount exceeds 2 grams per 100 grams of fat. |
(1)
excluding aqueous green tea extracts containing (-)- epigallocatechin-3-gallate which after reconstitution in beverages have a composition comparable to traditional green tea infusions. |
Part C — Substances under Community scrutiny
Green tea extracts containing (-)- epigallocatechin-3-gallate ( 4 )
Monacolins from red yeast rice
Preparations from the bark of Rhamnus frangula L., Rhamnus purshiana DC. containing hydroxyanthracene derivatives
Preparations from the leaf or fruit of Cassia senna L. containing hydroxyanthracene derivatives
Preparations from the root or rhizome of Rheum palmatum L., Rheum officinale Baillon and their hybrids containing hydroxyanthracene derivatives
▼M9 —————
( 1 ) OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 575/2006 (OJ L 100, 8.4.2006, p. 3).
( 2 ) OJ L 179, 14.7.1999, p. 1. Regulation as last amended by Regulation (EC) No 2165/2005 (OJ L 345, 28.12.2005, p. 1).
( 3 ) OJ L 304, 22.11.2011, p. 18
( *1 ) Menaquinone occurring principally as menaquinone-7 and, to a minor extent, menaquinone-6.
( *2 ) Selenium-enriched yeasts produced by culture in the presence of sodium selenite as selenium source and containing, in the dried form as marketed, not more than 2,5 mg Se/g. The predominant organic selenium species present in the yeast is selenomethionine (between 60 and 85 % of the total extracted selenium in the product). The content of other organic selenium compounds including selenocysteine shall not exceed 10 % of total extracted selenium. Levels of inorganic selenium normally shall not exceed 1 % of total extracted selenium.
( 4 ) excluding aqueous green tea extracts containing (-)- epigallocatechin-3-gallate which after reconstitution in beverages have a composition comparable to traditional green tea infusions.