
CHAPTER I
Article 1 

1. This Regulation establishes compositional and information requirements for the following categories of food:
(a) infant formula and follow-on formula;
(b) processed cereal-based food and baby food;
(c) food for special medical purposes;
(d) total diet replacement for weight control.
2. This Regulation establishes a  Great Britain  list of substances that may be added to one or more of the categories of food referred to in paragraph 1 and lays down the rules applicable to the updating of that list.
Article 2 

1. For the purposes of this Regulation, the following definitions shall apply:
(a) the definitions of ‘food’, ‘food business operator’, ‘retail’ and ‘placing on the market’ set out respectively in Article 2 and points (3), (7) and (8) of Article 3 of Regulation (EC) No 178/2002;
(b) the definitions of ‘prepacked food’, ‘labelling’ and ‘engineered nanomaterial’ set out respectively in points (e), (j) and (t) of Article 2(2) of Regulation (EU) No 1169/2011;
(c) the definitions of ‘nutrition claim’ and ‘health claim’ set out respectively in points (4) and (5) of Article 2(2) of Regulation (EC) No 1924/2006.
2. The following definitions shall also apply:
(a) ‘infant’ means a child under the age of 12 months;
(b) ‘young child’ means a child aged between one and three years;
(c) ‘infant formula’ means food intended for use by infants during the first months of life and satisfying by itself the nutritional requirements of such infants until the introduction of appropriate complementary feeding;
(d) ‘follow-on formula’ means food intended for use by infants when appropriate complementary feeding is introduced and which constitutes the principal liquid element in a progressively diversified diet of such infants;
(e) ‘processed cereal-based food’ means food:
((i)) intended to fulfil the particular requirements of infants in good health while they are being weaned, and of young children in good health as a supplement to their diet and/or for their progressive adaptation, to ordinary food; and
((ii)) pertaining to one of the following categories:

— simple cereals which are or have to be reconstituted with milk or other appropriate nutritious liquids,
— cereals with an added high protein food which are or have to be reconstituted with water or other protein-free liquid,
— pastas which are to be used after cooking in boiling water or other appropriate liquids,
— rusks and biscuits which are to be used either directly or, after pulverisation, with the addition of water, milk or other suitable liquids;
(f) ‘baby food’ means food intended to fulfil the particular requirements of infants in good health while they are being weaned, and of young children in good health as a supplement to their diet and/or for their progressive adaptation to ordinary food, excluding:
((i)) processed cereal-based food; and
((ii)) milk-based drinks and similar products intended for young children;
(g) ‘food for special medical purposes’ means food specially processed or formulated and intended for the dietary management of patients, including infants, to be used under medical supervision; it is intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved by modification of the normal diet alone;
(h) ‘total diet replacement for weight control’ means food specially formulated for use in energy restricted diets for weight reduction which, when used as instructed by the food business operator, replaces the whole daily diet;
(i) ‘Great Britain  list’ means the list set out in the Annex.
Article 3 
The appropriate authority may make regulations specifying:

((a)) whether a given food falls within the scope of this Regulation;
((b)) to which specific category of food referred to in Article 1(1) a given food belongs.
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Article 4 

1. Food referred to in Article 1(1) may only be placed on the market if it complies with this Regulation.
2. Food referred to in Article 1(1) shall only be allowed on the retail market in the form of prepacked food.
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Article 5 
In order to ensure a high level of health protection in relation to the persons for whom the food referred to in Article 1(1) of this Regulation is intended, the precautionary principle as set out in Article 7 of Regulation (EC) No 178/2002 shall apply.
CHAPTER II
SECTION 1
Article 6 

1. Food referred to in Article 1(1) shall comply with any requirement of   assimilated  law  applicable to food.
2. The requirements laid down in this Regulation shall prevail over any conflicting requirement of  assimilated  law applicable to food.
Article 7 
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Article 8 
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Article 9 

1. The composition of food referred to in Article 1(1) shall be such that it is appropriate for satisfying the nutritional requirements of, and is suitable for, the persons for whom it is intended, in accordance with generally accepted scientific data.
2. Food referred to in Article 1(1) shall not contain any substance in such quantity as to endanger the health of the persons for whom it is intended.For substances which are engineered nanomaterials, compliance with the requirement referred to in the first subparagraph shall be demonstrated on the basis of adequate test methods, where appropriate.
3. On the basis of generally accepted scientific data, substances added to food referred to in Article 1(1) for the purposes of the requirements under paragraph 1 of this Article shall be bio-available for use by the human body, have a nutritional or physiological effect and be suitable for the persons for whom the food is intended.
4. Without prejudice to Article 4(1) of this Regulation, food referred to in Article 1(1) of this Regulation may contain substances covered by  Regulation (EU) 2015/2283, provided that those substances fulfil the conditions under that Regulation for being placed on the market.
5. The labelling, presentation and advertising of food referred to in Article 1(1) shall provide information for the appropriate use of such food, and shall not mislead, or attribute to such food the property of preventing, treating or curing a human disease, or imply such properties.
6. Paragraph 5 shall not prevent the dissemination of any useful information or recommendations exclusively intended for persons having qualifications in medicine, nutrition, pharmacy, or for other healthcare professionals responsible for maternal care and childcare.
Article 10 

1. The labelling, presentation and advertising of infant formula and follow-on formula shall be designed so as not to discourage breast-feeding.
2. The labelling, presentation and advertising of infant formula, and the labelling of follow-on formula shall not include pictures of infants, or other pictures or text which may idealise the use of such formulae.Without prejudice to the first subparagraph, graphic representations for easy identification of infant formula and follow-on formula and for illustrating methods of preparation shall be permitted.
SECTION 2
Article 11 

1. ... Taking into account relevant technical and scientific progress,  and having regard to such scientific opinion as an appropriate authority considers appropriate, the appropriate authority may make regulations, with respect to the following:
(a) the specific compositional requirements applicable to food referred to in Article 1(1), with the exception of requirements as set out in the Annex;
(b) the specific requirements on the use of pesticides in products intended for the production of food referred to in Article 1(1) and on pesticide residues in such food. ...
(c) the specific requirements on labelling, presentation and advertising of food referred to in Article 1(1), including the authorisation of nutrition and health claims in relation thereto;
(d) the notification requirements for the placing on the market of food referred to in Article 1(1), in order to facilitate the efficient official monitoring of such food, ...;
(e) the requirements concerning promotional and commercial practices relating to infant formula;
(f) the requirements concerning information to be provided in relation to infant and young child feeding in order to ensure adequate information on appropriate feeding practices;
(g) the specific requirements for food for special medical purposes developed to satisfy the nutritional requirements of infants, including compositional requirements and requirements on the use of pesticides in products intended for the production of such food, pesticide residues, labelling, presentation, advertising, and promotional and commercial practices, as appropriate....
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Article 12 
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Article 13 
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Article 14 
The Secretary of State, the Scottish Ministers and the Welsh Ministers  may adopt technical guidelines to facilitate compliance by food business operators, in particular  small or medium sized enterprises as defined in the Annex to Commission Recommendation 2003/361/EC concerning the definition of micro, small and medium-sized enterprises, with this Chapter and Chapter III , as it applies in their territory. For the purposes of this Article, the Annex to Commission Recommendation 2003/361/EC concerning the definition of micro, small and medium-sized enterprises  is to be read as if—
(a) in Article 2—
(i) in paragraph 1, for  “EUR 50 million, and/or an annual balance sheet total not exceeding EUR 43 million” there were substituted “£44,000,000, and/or an annual balance sheet total not exceeding £38,000,000”;
(ii) in paragraph 2, for  “EUR 10 million” there were substituted “£8,800,000”;
(iii) in paragraph 3, for  “EUR 2 million” there were substituted “£1,750,000”;
(b) in Article 3—
(i) in paragraph 2(a), for  “EUR 1 250 000” there were substituted “£1,100,000”;
(ii) in paragraph 2(d), for  “EUR 10 million” there were substituted “£8,800,000”;
(iii) in paragraph 5, for  “by national or Community rules” there were substituted “under the law of  Great Britain  (or any part of it)”;
(c) in Article 5, in paragraph (b), for  “national law” there were substituted “the law of  Great Britain  (or any part of it)”.
CHAPTER III
Article 15 

1. Substances belonging to the following categories of substances may be added to one or more of the categories of food referred to in Article 1(1), provided that these substances are included in the Great Britain list set out in the Annex and comply with the elements contained in the Great Britain list in accordance with paragraph 3 of this Article:
(a) vitamins;
(b) minerals;
(c) amino acids;
(d) carnitine and taurine;
(e) nucleotides;
(f) choline and inositol.
2. Substances that are included in the Great Britain list shall meet the general requirements set out in Articles 6 and 9 and, where applicable, the specific requirements established in accordance with Article 11.
3. The Great Britain list shall contain the following elements:
(a) the category of food referred to in Article 1(1) to which substances belonging to the categories of substances listed in paragraph 1 of this Article may be added;
(b) the name, the description of the substance and, where appropriate, the specification of its form;
(c) where appropriate, the conditions of use of the substance;
(d) where appropriate, the purity criteria applicable to the substance.
4. Purity criteria established by   assimilated  law and any other legislation applying in any part of  Great Britain  applicable to food, which apply to the substances included in the Great Britain list when they are used in the manufacture of food for purposes other than those covered by this Regulation, shall also apply to those substances when they are used for purposes covered by this Regulation unless otherwise specified in this Regulation.
5. For substances included in the Great Britain list for which purity criteria are not established by   assimilated  law and any other legislation applying in any part of  Great Britain  applicable to food, generally acceptable purity criteria recommended by international bodies shall apply until the establishment of such criteria....
6. In order to take into account technical progress, scientific developments or the protection of consumers’ health,  an appropriate authority may make regulations in relation to the categories of substances listed in paragraph 1 of this Article  with respect to the following:
(a) the removal of a category of substances;
(b) the addition of a category of substances that have a nutritional or physiological effect.
7. Substances belonging to categories not listed in paragraph 1 of this Article may be added to food referred to in Article 1(1), provided that they satisfy the general requirements set out in Articles 6 and 9 and, where applicable, the specific requirements established in accordance with Article 11.
Article 16 

1. ... In order to take into account technical progress, scientific developments or the protection of consumers’ health,  the appropriate authority may by regulations  amend the Annex, with respect to the following:
(a) the addition of a substance to the Great Britain list;
(b) the removal of a substance from the Great Britain list;
(c) the addition, removal or amendment of the elements referred to in Article 15(3).
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CHAPTER IV
Article 16A 

(1.) Any power to make regulations under this Regulation may be exercised by the Secretary of State for the whole or part of  Great Britain  if consent is given by—
(a) for regulations applying in relation to Scotland, the Scottish Ministers;
(b) for regulations applying in relation to Wales, the Welsh Ministers;
(2.) 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.
(3.) In this Regulation–
 “appropriate authority” means:
((a)) for regulations applying in relation to England, the Secretary of State;
((b)) for regulations applying in relation to Scotland, the Scottish Ministers;
((c)) for regulations applying in relation to Wales, the Welsh Ministers;
 “enactment” includes any enactment of the types specified in the definition of  ‘enactment’ in section 20(1) of the European Union (Withdrawal) Act 2018.
Article 16B 

(1.) Any power of the Secretary of State to make regulations under this Regulation is exercisable by statutory instrument.
(2.) A statutory instrument containing regulations made under this Regulation is subject to annulment in pursuance of a resolution of either House of Parliament.
Article 16C 

(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 16D 

(1.) Any power of the Welsh Ministers to make regulations under this Regulation is exercisable by statutory instrument.
(2.) A statutory instrument containing regulations made under this Regulation by the Welsh Ministers is subject to annulment in pursuance of a resolution of the National Assembly for Wales.
Article 17 
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Article 18 
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Article 19 
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CHAPTER V
Article 20 
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Article 21 

1. Food referred to in Article 1(1) of this Regulation which does not comply with this Regulation but complies with Directive 2009/39/EC, and, as applicable, with Regulation (EC) No 953/2009 and Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, and which is placed on the market or labelled before 20 July 2016 may continue to be marketed after that date until stocks of such food are exhausted....
2. Food which is not referred to in Article 1(1) of this Regulation but which is placed on the market or labelled in accordance with Directive 2009/39/EC and Regulation (EC) No 953/2009, and, as applicable, with Directive 96/8/EC and Regulation (EC) No 41/2009 before 20 July 2016 may continue to be marketed after that date until stocks of such food are exhausted.
(3.) In this Article, any reference to compliance with a provision of the Directive is to be read as a reference to complying with that provision as would be required if the provision formed part of domestic law.
Article 22 
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This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX
Substance Category of food
Infant formula and follow on formula Processed cereal-based food and baby food Food for special medical purposes Total diet replacement for weight control
Vitamins      
Vitamin A     
retinol X X X X
retinyl acetate X X X X
retinyl palmitate X X X X
beta-carotene  X X X
Vitamin D     
ergocalciferol X X X X
cholecalciferol X X X X
Vitamin E     
D-alpha tocopherol X X X X
DL-alpha tocopherol X X X X
D-alpha tocopheryl acetate X X X X
DL-alpha tocopheryl acetate X X X X
D-alpha-tocopheryl acid succinate   X X
D-alpha-tocopheryl polyethylene glycol-1000 succinate (TPGS)   X 
Vitamin K     
phylloquinone (phytomenadione) X X X X
Menaquinone   X X
Vitamin C     
L-ascorbic acid X X X X
sodium-L-ascorbate X X X X
calcium-L-ascorbate X X X X
potassium-L-ascorbate X X X X
L-ascorbyl 6-palmitate X X X X
Thiamin     
thiamin hydrochloride X X X X
thiamin mononitrate X X X X
Riboflavin     
riboflavin X X X X
riboflavin 5’-phosphate, sodium X X X X
Niacin     
nicotinic acid X X X X
nicotinamide X X X X
Vitamin B6     
pyridoxine hydrochloride X X X X
pyridoxine 5’-phosphate X X X X
pyridoxine dipalmitate  X X X
Folate     
folic acid (pteroylmonoglutamic acid) X X X X
calcium-L-methylfolate  X  X X
Vitamin B12     
cyanocobalamin X X X X
hydroxocobalamin X X X X
Biotin     
D-biotin X X X X
Pantothenic Acid     
D-pantothenate, calcium X X X X
D-pantothenate, sodium X X X X
dexpanthenol X X X X
Minerals      
Potassium     
potassium bicarbonate X  X X
potassium carbonate X  X X
potassium chloride X X X X
potassium citrate X X X X
potassium gluconate X X X X
potassium glycerophosphate  X X X
potassium lactate X X X X
potassium hydroxide X  X X
potassium salts of orthophosphoric acid X  X X
magnesium potassium citrate   X X
Calcium     
calcium carbonate X X X X
calcium chloride X X X X
calcium salts of citric acid X X X X
calcium gluconate X X X X
calcium glycerophosphate X X X X
calcium lactate X X X X
calcium salts of orthophosphoric acid X X X X
calcium hydroxide X X X X
calcium oxide  X X X
calcium sulphate   X X
calcium bisglycinate   X X
calcium citrate malate   X X
calcium malate   X X
calcium L-pidolate   X X
calcium phosphoryl oligosaccharides
                              
                              X
                            
Magnesium     
magnesium acetate   X X
magnesium carbonate X X X X
magnesium chloride X X X X
magnesium salts of citric acid X X X X
magnesium gluconate X X X X
magnesium glycerophosphate  X X X
magnesium salts of orthophosphoric acid X X X X
magnesium lactate  X X X
magnesium hydroxide X X X X
magnesium oxide X X X X
magnesium sulphate X X X X
magnesium L-aspartate   X 
magnesium bisglycinate   X X
magnesium L-pidolate   X X
magnesium potassium citrate   X X
Iron     
ferrous carbonate  X X X
ferrous citrate X X X X
ferric ammonium citrate X X X X
ferrous gluconate X X X X
ferrous fumarate X X X X
ferric sodium diphosphate  X X X
ferrous lactate X X X X
ferrous sulphate X X X X
ferrous ammonium phosphate   X X
ferric sodium EDTA   X X
ferric diphosphate (ferric pyrophosphate) X X X X
ferric saccharate  X X X
elemental iron (carbonyl + electrolytic + hydrogen reduced)  X X X
ferrous bisglycinate
                            
                              X
                            
                              X
                            
                              X
                            
                              X
ferrous L-pidolate   X X
Zinc     
zinc acetate X X X X
zinc chloride X X X X
zinc citrate X X X X
zinc gluconate X X X X
zinc lactate X X X X
zinc oxide X X X X
zinc carbonate   X X
zinc sulphate X X X X
zinc bisglycinate   X X
Copper     
cupric carbonate X X X X
cupric citrate X X X X
cupric gluconate X X X X
cupric sulphate X X X X
copper lysine complex X X X X
Manganese     
manganese carbonate X X X X
manganese chloride X X X X
manganese citrate X X X X
manganese gluconate X X X X
manganese glycerophosphate  X X X
manganese sulphate X X X X
Fluoride     
potassium fluoride   X X
sodium fluoride   X X
Selenium     
sodium selenate X  X X
sodium hydrogen selenite   X X
sodium selenite X  X X
selenium enriched yeast   X X
Chromium     
chromium (III) chloride and its hexahydrate   X X
chromium (III) sulphate and its hexahydrate   X X
chromium picolinate   X X
Molybdenum     
ammonium molybdate   X X
sodium molybdate   X X
Iodine     
potassium iodide X X X X
potassium iodate X X X X
sodium iodide X X X X
sodium iodate  X X X
Sodium     
sodium bicarbonate X  X X
sodium carbonate X  X X
sodium chloride X  X X
sodium citrate X  X X
sodium gluconate X  X X
sodium lactate X  X X
sodium hydroxide X  X X
sodium salts of orthophosphoric acid X  X X
Boron     
sodium borate   X X
boric acid   X X
Amino acids      
L-alanine  — X X
L-arginine Xand its hydrochloride Xand its hydrochloride X X
L-aspartic acid   X 
L-citrulline   X 
L-cysteine Xand its hydrochloride Xand its hydrochloride X X
Cystine Xand its hydrochloride Xand its hydrochloride X X
L-histidine Xand its hydrochloride Xand its hydrochloride X X
L-glutamic acid   X X
L-glutamine   X X
glycine   X 
L-isoleucine Xand its hydrochloride Xand its hydrochloride X X
L-leucine Xand its hydrochloride Xand its hydrochloride X X
L-lysine Xand its hydrochloride Xand its hydrochloride X X
L-lysine acetate   X X
L-methionine X X X X
L-ornithine   X X
L-phenylalanine X X X X
L-proline   X 
L-threonine X X X X
L-tryptophan X X X X
L-tyrosine X X X X
L-valine X X X X
L-serine   X 
L-arginine-L-aspartate   X 
L-lysine-L-aspartate   X 
L-lysine-L-glutamate   X 
N-acetyl-L-cysteine   X 
N-acetyl-L-methionine   X (in products intended for persons over 1 year of age) 
Carnitine and taurine      
L-carnitine X X X X
L-carnitine hydrochloride X X X X
taurine X  X X
L-carnitine-L-tartrate X  X X
Nucleotides      
adenosine 5’-phosphoric acid (AMP) X  X X
sodium salts of AMP X  X X
cytidine 5’-monophosphoric acid (CMP) X  X X
sodium salts of CMP X  X X
guanosine 5’-phosphoric acid (GMP) X  X X
sodium salts of GMP X  X X
inosine 5’-phosphoric acid (IMP) X  X X
sodium salts of IMP X  X X
uridine 5’-phosphoric acid (UMP) X  X X
sodium salts of UMP X  X X
Choline and inositol      
choline X X X X
choline chloride X X X X
choline bitartrate X X X X
choline citrate X X X X
inositol X X X X



