
CHAPTER I
Article 1 

1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2. The provisions of this Regulation regarding vitamins and minerals shall not apply to food supplements covered by Directive 2002/46/EC.
3. This Regulation shall apply without prejudice to specific provisions laid down in  other relevant enactments  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 
For the purposes of this Regulation:
(1) ‘expert committee’ means a committee with appropriate expertise in the matter to be considered, approved by an appropriate authority to give advice for the purposes of this Regulation;
(2) ‘other substance’ means a substance other than a vitamin or a mineral that has a nutritional or physiological effect;
(3) ‘appropriate authority’ means:
(a) for regulations applying in relation to England and for the establishment and maintenance of a register in relation to England, the Secretary of State;
(b) for regulations applying in relation to Scotland and for the establishment and maintenance of a register in relation to Scotland, the Scottish Ministers;
(c) for regulations applying in relation to Wales and for the establishment and maintenance of a register in relation to Wales, the Welsh Ministers;
(4) But the appropriate authority is the Secretary of State if consent is given by:
(a) for regulations applying in relation to Scotland and for the establishment and maintenance of a register in relation to Scotland, the Scottish Ministers;
(b) for regulations applying in relation to Wales and for the establishment and maintenance of a register in relation to Wales, the Welsh Ministers;
(5) ‘relevant authorities’ means the Secretary of State, the Scottish Ministers or the Welsh Ministers, the Department of Health.
CHAPTER II
Article 3 

1. Only vitamins and/or minerals listed in Annex I, in the forms listed in Annex II, may be added to foods, subject to the rules laid down in this Regulation.
2. 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.
3. The appropriate authority may by regulations, after taking into account the opinion of an expert committee, specify modifications to the lists referred to in paragraph 1 of this Article....
                              Prior to making  regulations under this paragraph, the appropriate authority  shall carry out consultations with interested parties, in particular food business operators and consumer groups.
Article 4 
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 paragraph B3 of Annex VIII to Regulation (EU) No 1308/2013; and
((ii)) which were marketed prior to the adoption of this Regulation; ...
((iii)) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .,
and provided that no nutrition or health claim is made.
The appropriate authority may by regulations determine the additional foods or categories of foods to which particular vitamins and minerals may not be added, in the light of scientific evidence and taking into account their nutritional value.
Article 5 

1. The appropriate authority may by regulations determine  the purity criteria for vitamin formulations and mineral substances listed in Annex II ..., except where they apply pursuant to paragraph 2 of this Article.
2. Purity criteria for vitamin formulations and mineral substances listed in Annex II, specified by  other relevant enactments  for their use in the manufacture of foodstuffs for purposes other than those covered by this Regulation, shall apply.
3. For those vitamin formulations and mineral substances listed in Annex II for which purity criteria are not specified by  other relevant enactments, and until  the appropriate authority makes regulations under paragraph 1, generally acceptable purity criteria recommended by international bodies shall be applicable ....
Article 6 

1. 
                              When a vitamin or a mineral is added to foods, the total amount of the vitamin or mineral present, for whatever purpose, in the food as sold shall not exceed maximum amounts. Measures setting that amount  may be adopted by regulations made by the appropriate authority. For concentrated and dehydrated products, the maximum amounts set shall be those present in the foods when prepared for consumption according to the manufacturer's instructions.
2. The appropriate authority may by regulations specify  conditions restricting or prohibiting the addition of a specific vitamin or mineral to a food or a category of foods ....
3. 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.
4. When the maximum amounts referred to in paragraph 1 and the conditions referred to in paragraph 2 are set, due account shall also be taken of reference intakes of vitamins and minerals for the population.
5. 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.
6. 
                              The addition of a vitamin or a mineral to a food shall result in the presence of that vitamin or mineral in the food in at least a significant amount where this is defined according to the  Annex XIII to Regulation (EU) No 1169/2011. Measures determining the minimum amounts, including any lower amounts, by derogation from the significant amounts mentioned above, for specific foods or categories of foods  may be adopted by regulations made by the appropriate authority.
Article 7 

1. 
                              The labelling, presentation and advertising of foods to which vitamins and minerals have been added shall not include any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients. Where appropriate, a derogation concerning a specific nutrient  may be adopted by regulations made by the appropriate authority.
2. The labelling, presentation and advertising of foods to which vitamins and minerals have been added shall not mislead or deceive the consumer as to the nutritional merit of a food that may result from the addition of these nutrients.
3. 
                              Nutrition labelling of products to which vitamins and minerals have been added and which are covered by this Regulation shall be compulsory. The information to be provided shall consist of that specified in Article 30(1) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 
                              25 October 2011
                               on the provision of food information to consumers
                              
                               and of the total amounts present of the vitamins and minerals when added to the food.
4. The labelling of products to which vitamins and minerals have been added may bear a statement indicating such addition under the conditions laid down in Regulation (EC) No 1924/2006.
5. This Article shall apply without prejudice to other provisions of food law applicable to specified categories of foods.
6. Rules for implementing this Article may be specified in  regulations made by the appropriate authority.
CHAPTER III
Article 8 

1. The procedure provided for in this Article shall be followed where a substance other than vitamins or minerals, or an ingredient containing a substance other than vitamins or minerals, is added to foods or used in the manufacture of foods under conditions that would result in the ingestion of amounts of this substance greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and/or would otherwise represent a potential risk to consumers.
2. Following an assessment of available evidence by an expert committee, the appropriate authority may make regulations, 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.
                                 
...
3. Enactments  applicable to specified foods may provide for restrictions or prohibitions on the use of certain substances in addition to those laid down in this Regulation.
4. Food business operators, or any other interested parties, may at any time submit to the appropriate authority a file containing the scientific data demonstrating the safety of a substance listed in Annex III, Part C, under the conditions of its use in a food or in a category of foods and explaining the purpose of that use. The appropriate authority shall submit the file to an expert committee for evaluation and shall inform the other relevant authorities of the submission and shall make the file available to them.

                           5. 
                              Within four years from the date a substance has been listed in Annex III, Part C, the appropriate authority must consider, in consultation with the other relevant authorities and taking into account the opinion of the expert committee on any files submitted for evaluation as mentioned in paragraph 4 of this Article, whether to make regulations 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.
6. The appropriate authority may by regulations amend Commission Implementing Regulation (EU) No 307/2012 in order to modify the implementing rules for the application of this Article.
CHAPTER IV
Article 9 

1. The appropriate authority must establish and maintain a  Register on the addition of vitamins and minerals and of certain other substances to foods, hereinafter referred to as ‘the Register’.
2. 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) information regarding enactments applicable in any part of  Great Britain  on:
(i) the mandatory addition of vitamins and minerals to specified foods or categories of foods; or
(ii) the prohibition or restriction on the use of certain other substances in the manufacture of specified foods;
(e) any restrictions on the addition of vitamins and minerals as set out in Article 4;
(f) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(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).
3. The Register shall be made available to the public.
Article 9A 

(1.) Regulations made under this Regulation may:
(a) contain consequential, incidental, supplementary, transitional or saving provision (including provision amending, repealing or revoking enactments);
(b) make different provision for different purposes.
Article 9B 

(1.) Any power of the Secretary of State to make regulations under this Regulation is exercisable by statutory instrument.
(2.) A statutory instrument made under this Regulation is subject to annulment in pursuance of a resolution of either House of Parliament.
(3.) The Secretary of State may not make regulations under this Regulation which will apply in Scotland or Wales  without the consent of:
(a) the Scottish Ministers, in respect of any proposed application in Scotland; and
(b) the Welsh Ministers, in respect of any proposed application in Wales.
Article 9C 

(1.) For regulations made by the Scottish Ministers, see section 27 of the Interpretation and Legislative Reform (Scotland) Act 2010.
(2.) Regulations made by the Scottish Ministers under this Regulation are subject to the negative procedure (see section 28 of the Interpretation and Legislative Reform (Scotland) Act 2010).
Article 9D 

(1.) Any power of the Welsh Ministers to make regulations under this Regulation is exercisable by statutory instrument.
(2.) Regulations made by the Welsh Ministers under this Regulation are subject to annulment in pursuance of a resolution of the National Assembly for Wales.
Article 10 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Article 11 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Article 12 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Article 13 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Article 14
                   
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Article 15 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Article 16 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Article 17 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Article 18 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I
1. 
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. 
Calcium

Magnesium

Iron

Copper

Iodine

Zinc

Manganese

Sodium

Potassium

Selenium

Chromium

Molybdenum

Fluoride

Chloride

Phosphorus

Boron

ANNEX II
1. 
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

thiamin hydrochloride

thiamin mononitrate

riboflavin

riboflavin 5′-phosphate, sodium

nicotinic acid

nicotinamide

D-pantothenate, calcium

D-pantothenate, sodium

dexpanthenol

pyridoxine hydrochloride

pyridoxine 5′-phosphate

pyridoxine dipalmitate

pteroylmonoglutamic acid

calcium-L-methylfolate

cyanocobalamin

hydroxocobalamin

D-biotin

L-ascorbic acid

sodium-L-ascorbate

calcium-L-ascorbate

potassium-L-ascorbate

L-ascorbyl 6-palmitate

2. 
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

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

PART B

Restricted substance Conditions of use Additional requirements
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.
Part C — Substances under Community scrutiny
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
