Commission Delegated Regulation (EU) 2016/127 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding (Text with EEA relevance)

Article 1

Placing on the market

Article 2

Compositional requirements

Article 3

Suitability of ingredients

Article 4

Requirements on pesticides

Those levels shall be determined by generally accepted standardised analytical methods.

However, for the purpose of checks, plant protection products containing the active substances listed in Annex V are considered not to have been used if their residues do not exceed a level of 0,003 mg/kg.

Article 5

Name of the food

Article 6

Specific requirements on food information

In addition to the mandatory particulars listed in Article 9(1) of Regulation (EU) No 1169/2011, the following shall be additional mandatory particulars for infant formula:

(a) a statement that the product is suitable for infants from birth when they are not breast fed;

(b) instructions for appropriate preparation, storage and disposal of the product and a warning against the health hazards of inappropriate preparation and storage;

(c) a statement concerning the superiority of breast feeding and a statement recommending that the product be used only on the advice of independent persons having qualifications in medicine, nutrition or pharmacy, or other professionals responsible for maternal and child care. The particulars referred to in this point shall be preceded by the words ‘important notice’ or their equivalent and shall be given also in the presentation and advertising of infant formula.

In addition to the mandatory particulars listed in Article 9(1) of Regulation (EU) No 1169/2011, the following shall be additional mandatory particulars for follow-on formula:

(a) a statement that the product is suitable only for infants over the age of six months, that it should form only part of a diversified diet, that it is not to be used as a substitute for breast milk during the first six months of life and that the decision to begin complementary feeding, including any exception to six months of age, should be made only on the advice of independent persons having qualifications in medicine, nutrition or pharmacy, or other professionals responsible for maternal and child care, based on the individual infant's specific growth and development needs;

(b) instructions for appropriate preparation, storage and disposal of the product and a warning against the health hazards of inappropriate preparation and storage.

The labelling, presentation and advertising of infant formula and follow-on formula shall not use the terms ‘humanised’, ‘maternalised’, ‘adapted’, or terms similar to them.

The labelling, presentation and advertising of infant formula and follow-on formula shall be designed in such a way that it avoids any risk of confusion between infant formula and follow-on formula and enables consumers to make a clear distinction between them, in particular as to the text, images and colours used.

Article 7

Specific requirements on the nutrition declaration

The mandatory nutrition declaration for infant formula shall also include the amount of choline, inositol and carnitine.

By way of derogation from Article 30(1) of Regulation (EU) No 1169/2011, the mandatory nutrition declaration for infant formula and follow-on formula shall not include the amount of salt.

In addition to the information referred to in Article 30(2)(a) to (e) of Regulation (EU) No 1169/2011, the content of the mandatory nutrition declaration for infant formula and follow-on formula may be supplemented with one or more of the following:

(a) the amounts of components of protein, carbohydrate or fat;

(b) the whey protein/casein ratio;

(c) the amount of any of the substances listed in Annex I or Annex II to this Regulation or in the Annex to Regulation (EU) No 609/2013, where the indication of any of those substances is not covered by paragraph 1;

(d) the amount of any of the substances added to the product pursuant to Article 3.

In addition to the form of expression referred to in paragraph 6, in the case of follow-on formula, the declaration on vitamins and minerals in respect of the vitamins and minerals listed in Annex VII to this Regulation may be expressed as a percentage of the reference intakes set out in that Annex in relation to per 100 ml of the food ready for use after preparation in accordance with the manufacturer's instructions.

Particulars not listed in Annex XV to Regulation (EU) No 1169/2011 that do not belong to or are not components of any of the entries of that Annex shall be presented in the nutrition declaration after the last entry of that Annex.

Article 8

Nutrition and health claims for infant formula

Nutrition and health claims shall not be made on infant formula.

Article 9

Statements related to lactose and docosahexaenoic acid (DHA)

When the statement ‘lactose free’ is used for infant formula and follow-on formula manufactured from protein sources other than soya protein isolates, it shall be accompanied by the statement ‘not suitable for infants with galactosaemia’, which shall be indicated with the same font size and prominence as the statement ‘lactose free’ and in close proximity to it.

Article 10

Requirements for promotional and commercial practices for infant formula

Member States may further restrict or prohibit such advertising. Such advertising shall contain only information of a scientific and factual nature. Such information shall not imply or create a belief that bottle-feeding is equivalent or superior to breast feeding.

Article 11

Requirements on information relating to infant and young child feeding

Informational and educational materials, whether written or audiovisual, dealing with the feeding of infants and intended to reach pregnant women and mothers of infants and young children, shall include clear information on all the following points:

(a) the benefits and superiority of breast feeding;

(b) maternal nutrition and the preparation for and maintenance of breast feeding;

(c) the possible negative effect on breast feeding of introducing partial bottle feeding;

(d) the difficulty of reversing the decision not to breast feed;

(e) where needed, the proper use of infant formula.

Where such materials contain information about the use of infant formula, they shall include the social and financial implications of its use, the health hazards of inappropriate foods or feeding methods, and, in particular, the health hazards of improper use of infant formula. Such material shall not use any pictures which may idealise the use of infant formula.

Article 12

Notification

Article 13

Directive 2006/141/EC

In accordance with Article 20(4) of Regulation (EU) No 609/2013, Directive 2006/141/EC is repealed with effect from 22 February 2020. However, Directive 2006/141/EC shall continue to apply until 21 February 2022 to infant formula and follow-on formula manufactured from protein hydrolysates

References to Directive 2006/141/EC in other acts shall be construed as references to this Regulation in accordance with the scheme set out in the first paragraph.

Article 14

Entry into force and application

This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.

It shall apply from 22 February 2020, except in respect of infant formula and follow-on formula manufactured from protein hydrolysates, to which it shall apply from 22 February 2022.

For the purposes of the second subparagraph of Article 21(1) of Regulation (EU) No 609/2013, in respect of infant formula and follow-on formula manufactured from protein hydrolysates the later date referred to in the second paragraph of this Article shall be considered as the date of application.

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

ANNEX I

COMPOSITIONAL REQUIREMENTS REFERRED TO IN ARTICLE 2(1)

1. ENERGY

Minimum	Maximum
250 kJ/100 ml	293 kJ/100 ml
(60 kcal/100 ml)	(70 kcal/100 ml)

2. PROTEINS

(Protein content = nitrogen content × 6,25)

Minimum	Maximum
0,43 g/100 kJ	0,6 g/100 kJ
(1,8 g/100 kcal)	(2,5 g/100 kcal)

For an equal energy value, infant formula manufactured from cows' milk or goats' milk proteins must contain an available quantity of each indispensable and conditionally indispensable amino acid at least equal to that contained in the reference protein as set out in Section A of Annex III. Nevertheless, for calculation purposes, the concentration of methionine and cysteine may be added together if the methionine:cysteine ratio is not greater than 2, and the concentration of phenylalanine and tyrosine may be added together if the tyrosine:phenylalanine ratio is not greater than 2. The ratio of methionine:cysteine and of tyrosine:phenylalanine may be greater than 2, provided that the suitability of the product concerned for infants is demonstrated in accordance with Article 3(3).

The L-carnitine content shall be at least equal to 0,3 mg/100 kJ (1,2 mg/100 kcal).

Minimum	Maximum
0,54 g/100 kJ	0,67 g/100 kJ
(2,25 g/100 kcal)	(2,8 g/100 kcal)

Only protein isolates from soya shall be used in manufacturing this infant formula.

For an equal energy value, infant formula manufactured from soya protein isolates, alone or in a mixture with cows' milk or goats' milk proteins, must contain an available quantity of each indispensable and conditionally indispensable amino acid at least equal to that contained in the reference protein as set out in Section A of Annex III. Nevertheless, for calculation purposes, the concentration of methionine and cysteine may be added together if the methionine:cysteine ratio is not greater than 2, and the concentration of phenylalanine and tyrosine may be added together if the tyrosine:phenylalanine ratio is not greater than 2. The ratio of methionine:cysteine and of tyrosine:phenylalanine may be greater than 2, provided that the suitability of the product concerned for infants is demonstrated in accordance with Article 3(3).

The L-carnitine content shall be at least equal to 0,3 mg/100 kJ (1,2 mg/100 kcal).

Infant formula manufactured from protein hydrolysates shall comply with the protein-related requirements provided under point 2.3.1, point 2.3.2, point 2.3.3, point 2.3.4 or point 2.3.5.

2.3.1.Protein-related requirements group A

2.3.1.1.Protein content

Minimum	Maximum
0,44  g/100  kJ	0,67  g/100  kJ
(1,86  g/100  kcal)	(2,8  g/100  kcal)

2.3.1.2.Protein source

Demineralised sweet whey protein derived from cows’ milk after enzymatic precipitation of caseins using chymosin, consisting of:

(a) 63 % caseino-glycomacropeptide free whey protein isolate with a minimum protein content of 95 % of dry matter and protein denaturation of less than 70 % and a maximum ash content of 3 %; and

(b) 37 % sweet whey protein concentrate with a minimum protein content of 87 % of dry matter and protein denaturation of less than 70 % and a maximum ash content of 3,5 %.

2.3.1.3.Protein processing

Two-stage hydrolysis process using a trypsin preparation with a heat-treatment step (from 3 to 10 minutes at 80 to 100 °C) between the two hydrolysis steps.

2.3.1.4.Indispensable and conditionally indispensable amino acids and L-carnitine

For an equal energy value, infant formula manufactured from protein hydrolysates must contain an available quantity of each indispensable and conditionally indispensable amino acid at least equal to that contained in the reference protein as set out in Section B of Annex III. Nevertheless, for calculation purposes, the concentration of methionine and cysteine may be added together if the methionine: cysteine ratio is not greater than 2, and the concentration of phenylalanine and tyrosine may be added together if the tyrosine: phenylalanine ratio is not greater than 2. The ratio of methionine: cysteine and of tyrosine: phenylalanine may be greater than 2, provided that the suitability of the product concerned for infants is demonstrated in accordance with Article 3(3).

The L-carnitine content shall be at least equal to 0,3 mg/100 kJ (1,2 mg/100 kcal).

2.3.2.Protein-related requirements group B

2.3.2.1.Protein content

Minimum	Maximum
0,55  g/100  kJ	0,67  g/100  kJ
(2,3  g/100  kcal)	(2,8  g/100  kcal)

2.3.2.2.Protein source

Whey protein derived from cows’ milk, consisting of:

(a) 77 % acid whey, coming from whey protein concentrate with a protein content of 35 to 80 %;

(b) 23 % sweet whey, coming from demineralised sweet whey with a minimum protein content of 12,5 %.

2.3.2.3.Protein processing

The source material is hydrated and heated. Following the heat-treatment step, the hydrolysis is carried out at a pH of 7,5 to 8,5 and a temperature of 55 to 70 °C with the use of an enzyme mixture of a serine endopeptidase and a protease/peptidase complex. The food enzymes are inactivated in a heat treatment step (from 2 to 10 seconds at 120 to 150 °C) during the production process.

2.3.2.4.Indispensable and conditionally indispensable amino acids and L-carnitine

For an equal energy value, infant formula manufactured from protein hydrolysates must contain an available quantity of each indispensable and conditionally indispensable amino acid at least equal to that contained in the reference protein as set out in Section A of Annex III. Nevertheless, for calculation purposes, the concentration of methionine and cysteine may be added together if the methionine: cysteine ratio is not greater than 2, and the concentration of phenylalanine and tyrosine may be added together if the tyrosine: phenylalanine ratio is not greater than 2. The ratio of methionine: cysteine and of tyrosine: phenylalanine may be greater than 2, provided that the suitability of the product concerned for infants is demonstrated in accordance with Article 3(3).

The L-carnitine content shall be at least equal to 0,3 mg/100 kJ (1,2 mg/100 kcal).

2.3.3.Protein-related requirements group C

2.3.3.1.Protein content

Minimum	Maximum
0,45  g/100  kJ	0,67  g/100  kJ
(1,9  g/100  kcal)	(2,8  g/100  kcal)

2.3.3.2.Protein source

Whey protein derived from cows’ milk, consisting of 100 % sweet whey protein concentrate with a minimum protein content of 80 %.

2.3.3.3.Protein processing

The source material is hydrated and heated. Prior to the hydrolysis, the pH is adjusted to 6,5–7,5 at a temperature of 50–65 °C. The hydrolysis is carried out with the use of an enzyme mixture of a serine endopeptidase and a metalloprotease. The food enzymes are inactivated in a heat treatment step (from 2 to 10 seconds at 110 to 140 °C) during the production process.

2.3.3.4.Indispensable and conditionally indispensable amino acids and L-carnitine

For an equal energy value, infant formula manufactured from protein hydrolysates must contain an available quantity of each indispensable and conditionally indispensable amino acid at least equal to that contained in the reference protein as set out in Section A of Annex III. Nevertheless, for calculation purposes, the concentration of methionine and cysteine may be added together if the methionine: cysteine ratio is not greater than 2, and the concentration of phenylalanine and tyrosine may be added together if the tyrosine: phenylalanine ratio is not greater than 2. The ratio of methionine: cysteine and of tyrosine: phenylalanine may be greater than 2, provided that the suitability of the product concerned for infants is demonstrated in accordance with Article 3(3).

The L-carnitine content shall be at least equal to 0,3 mg/100 kJ (1,2 mg/100 kcal).

2.3.4.Protein-related requirements group D

2.3.4.1.Protein content

Minimum	Maximum
0,57  g/100  kJ	0,67  g/100  kJ
(2,4  g/100  kcal)	(2,8  g/100  kcal)

2.3.4.2.Protein source

Whey protein derived from cow’s milk, consisting of 100 % sweet whey protein concentrate with a minimum protein content of 70 %.

2.3.4.3.Protein processing

The source material is hydrated and heated. Following the heat-treatment step, the hydrolysis is carried out at a pH of 7,0 to 8,0 and a temperature of 50 to 60 °C, using a two-stage hydrolysis process with the use of a serine endopeptidase and a metalloprotease. The food enzymes are inactivated by heat treatment (at 100 to 120 °C for at least 30 seconds) during the production process.

2.3.4.4.Indispensable and conditionally indispensable amino acids and L-carnitine

For an equal energy value, infant formula manufactured from protein hydrolysates must contain an available quantity of each indispensable and conditionally indispensable amino acid at least equal to that contained in the reference protein as set out in Section A of Annex III. Nevertheless, for calculation purposes, the concentration of methionine and cysteine may be added together if the methionine: cysteine ratio is not greater than 2, and the concentration of phenylalanine and tyrosine may be added together if the tyrosine: phenylalanine ratio is not greater than 2. The ratio of methionine: cysteine and of tyrosine: phenylalanine may be greater than 2, provided that the suitability of the product concerned for infants is demonstrated in accordance with Article 3(3).

The L-carnitine content shall be at least equal to 0,3 mg/100 kJ (1,2 mg/100 kcal).

2.3.5.Protein-related requirements group E

2.3.5.1.Protein content

Minimum	Maximum
0,48  g/100  kJ	0,67  g/100  kJ
(2,0  g/100  kcal)	(2,8  g/100  kcal)

2.3.5.2.Protein source

Whey protein derived from cow’s milk, consisting of 100 % whey protein concentrate with a minimum protein content of 80 %.

2.3.5.3.Protein processing