Commission Delegated Regulation (EU) 2016/127Show full title

Article 1 U.K. Placing on the market

1. Infant formula and follow-on formula may only be placed on the market if they comply with this Regulation.

2. No product other than infant formula may be marketed or otherwise represented as suitable for satisfying by itself the nutritional requirements of normal healthy infants during the first months of life until the introduction of appropriate complementary feeding.

Article 2 U.K. Compositional requirements

1. Infant formula shall comply with the compositional requirements set out in Annex I taking into account the values for the indispensable and conditionally indispensable amino acids set out in Annex III.

2. Follow-on formula shall comply with the compositional requirements set out in Annex II taking into account the values for the indispensable and conditionally indispensable amino acids set out in Annex III.

3. The values set out in Annexes I and II shall apply to the infant formula and follow-on formula ready for use, marketed as such or after preparation in accordance with the manufacturer's instructions. For such preparation nothing more than the addition of water shall be required.

Article 3 U.K. Suitability of ingredients

1. Infant formula shall be manufactured from protein sources as set out in point 2 of Annex I and other food ingredients, as the case may be, whose suitability for infants from birth has been established by generally accepted scientific data.

2. Follow-on formula shall be manufactured from protein sources as set out in point 2 of Annex II and other food ingredients, as the case may be, whose suitability for infants aged over six months has been established by generally accepted scientific data.

3. The suitability referred to in paragraphs 1 and 2 shall be demonstrated by the food business operator through a systematic review of the available data relating to the expected benefits and to safety considerations as well as, where necessary, appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies.

Article 4 U.K. Requirements on pesticides

[F1 1. For the purposes of this Article, ‘residue’ means pesticide residue as referred to in sub-paragraph (c) of Article 3(2) of Regulation (EC) No 396/2005.]

2. Infant formula and follow-on formula shall not contain residues at levels exceeding 0,01 mg/kg per active substance.

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

3. By way of derogation from paragraph 2, for the active substances listed in Annex IV, the maximum residue levels specified in that Annex shall apply.

4. Infant formula and follow-on formula shall only be produced from agricultural products for the production of which plant protection products containing the active substances listed in Annex V have not been used.

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.

5. The levels referred to in paragraphs 2, 3 and 4 shall apply to the infant formula and follow-on formula ready for use, marketed as such or after preparation in accordance with the manufacturer's instructions.

Textual Amendments

F1 Art. 4(1) substituted (10.2.2023) by The Food Supplements and Food for Specific Groups (Miscellaneous Amendments) Regulations 2023 (S.I. 2023/28), regs. 1(2), 4(2) (as amended by S.I. 2023/131, regs. 1(3), 2)

Article 5 U.K. Name of the food

1. The name of infant formula and follow-on formula other than infant formula and follow-on formula manufactured entirely from cows' milk or goats' milk proteins shall be as set out in Part A of Annex VI.

2. The name of infant formula and follow-on formula manufactured entirely from cows' milk or goats' milk proteins shall be as set out in Part B of Annex VI.

Article 6 U.K. Specific requirements on food information

1. Unless otherwise provided in this Regulation, infant formula and follow-on formula shall comply with Regulation (EU) No 1169/2011.

2. 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.

3. 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.

4. Article 13(2) and (3) of Regulation (EU) No 1169/2011 shall also apply to the additional mandatory particulars referred to in paragraphs 2 and 3 of this Article.

5. All mandatory particulars for infant formula and follow-on formula shall appear in a language easily understood by the consumers.

6. The labelling, presentation and advertising of infant formula and follow-on formula shall provide the necessary information about the appropriate use of the products, so as not to discourage breast feeding.

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 U.K. Specific requirements on the nutrition declaration

1. In addition to the information referred to in Article 30(1) of Regulation (EU) No 1169/2011, the mandatory nutrition declaration for infant formula and follow-on formula shall include the amount of each mineral substance and of each vitamin listed in Annex I or Annex II to this Regulation respectively and present in the product, with the exception of molybdenum.

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.

2. 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.

3. By way of derogation from Article 30(3) of Regulation (EU) No 1169/2011, the information included in the mandatory nutrition declaration for infant formula and follow-on formula shall not be repeated on the labelling.

4. The nutrition declaration shall be mandatory for all infant formula and follow-on formula, irrespective of the size of the largest surface of the packaging or container.

5. Articles 31 to 35 of Regulation (EU) No 1169/2011 shall apply to all the nutrients included in the nutrition declaration for infant formula and follow-on formula.

6. By way of derogation from Articles 31(3), 32(2) and 33(1) of Regulation (EU) No 1169/2011, the energy value and the amounts of nutrients of infant formula and follow-on formula shall be expressed per 100 ml of the food ready for use after preparation in accordance with the manufacturer's instructions. Where appropriate, the information may in addition refer to 100 g of the food as sold.

7. By way of derogation from Article 32(3) and (4) of Regulation (EU) No 1169/2011, the energy value and the amount of nutrients of infant formula and follow-on formula shall not be expressed as a percentage of the reference intakes set out in Annex XIII to that Regulation.

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.

8. The particulars included in the nutrition declaration for infant formula and follow-on formula that are not listed in Annex XV to Regulation (EU) No 1169/2011 shall be presented after the most relevant entry of that Annex they belong to or are components of.

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 U.K. Nutrition and health claims for infant formula

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

Article 9 U.K. Statements related to lactose and docosahexaenoic acid (DHA)

1. The statement ‘lactose only’ may be used for infant formula and follow-on formula provided that lactose is the only carbohydrate present in the product.

2. The statement ‘lactose free’ may be used for infant formula and follow-on formula provided that the lactose content in the product is not greater than 2,5 mg/100 kJ (10 mg/100 kcal).

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.

3. The statement ‘contains Docosahexaenoic acid (as required by the legislation for all infant formula)’ or ‘contains DHA (as required by the legislation for all infant formula)’ may only be used for infant formula placed on the market before 22 February 2025.

Article 10 U.K. Requirements for promotional and commercial practices for infant formula

1. Advertising of infant formula shall be restricted to publications specialising in baby care and scientific publications.

[F2 The appropriate authority] 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.

2. There shall be no point-of-sale advertising, giving of samples or any other promotional device to induce sales of infant formula directly to the consumer at the retail level, such as special displays, discount coupons, premiums, special sales, loss-leaders and tie-in sales.

3. Manufacturers and distributors of infant formula shall not provide, to the general public or to pregnant women, mothers or members of their families, free or low-priced products, samples or any other promotional gifts, either directly or indirectly via the health care system or health workers.

4. Donations or low-price sales of supplies of infant formula to institutions or organisations, whether for use in the institutions or for distribution outside them, shall only be used by or distributed for infants who have to be fed on infant formula and only for as long as required by such infants.

[F3 5. In this Article, “appropriate authority” means—

(a) in respect of advertising in England, the Secretary of State;

(b) in respect of advertising in Wales, the Welsh Ministers;

(c) in respect of advertising in Scotland, the Scottish Ministers.]

Textual Amendments

F2 Words in Art. 10(1) substituted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1476), regs. 1(3), 8(2)(a)

F3 Art. 10(5) inserted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1476), regs. 1(3), 8(2)(b)

Article 11 U.K. Requirements on information relating to infant and young child feeding

1. [F4 The appropriate authority] shall take measures ensuring that objective and consistent information is provided on infant and young child feeding for use by families and those involved in the field of infant and young child nutrition, and covering the planning, provision, design and dissemination of information and their control.

2. 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.

3. Donations of informational or educational equipment or materials by manufacturers or distributors shall be made only on request and with the written approval of the [F5 appropriate authority] or within guidelines given by that authority for this purpose. Such equipment or materials may bear the donating company's name or logo, but shall not refer to a proprietary brand of infant formula and shall be distributed only through the health care system.

[F6 4. In this Article, “appropriate authority” means—

(a) in respect of information or educational equipment or materials to be provided in England, the Secretary of State;

(b) in respect of information or educational equipment or materials to be provided in Wales, the Welsh Ministers;

(c) in respect of information or educational equipment or materials to be provided in Scotland, the Scottish Ministers.]

Textual Amendments

F4 Words in Art. 11(1) substituted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1476), regs. 1(3), 8(3)(a)

F5 Words in Art. 11(3) substituted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1476), regs. 1(3), 8(3)(b)

F6 Art. 11(4) inserted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1476), regs. 1(3), 8(3)(c)

[F7 Article 12 U.K. Notification

1. When infant formula is placed on the market, the food business operator shall notify the competent authority of each part of Great Britain where the product concerned is being marketed of the information appearing on the label, by sending to it a model of the label used for the product, and of any other information the competent authority may reasonably request to establish compliance with this Regulation.

2. When follow-on formula manufactured from protein hydrolysates or follow-on formula containing other substances than those listed in Annex II are placed on the market, the food business operator shall notify the competent authority of each part of Great Britain where the product concerned is being marketed of the information appearing on the label, by sending to it a model of the label used for the product, and of any other information the competent authority may reasonably request to establish compliance with this Regulation.

3. In this Article, “competent authority” means—

(a) in respect of infant formula, or follow-on formula manufactured from protein hydrolysates or follow-on formula containing other substances than those listed in Annex II being placed on the market in England, the Secretary of State;

(b) in respect of infant formula, or follow-on formula manufactured from protein hydrolysates or follow-on formula containing other substances than those listed in Annex II being placed on the market in Wales, the Welsh Ministers;

(c) in respect of infant formula, or follow-on formula manufactured from protein hydrolysates or follow-on formula containing other substances than those listed in Annex II being placed on the market in Scotland, Food Standards Scotland.]

Textual Amendments

F7 Art. 12 substituted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1476), regs. 1(3), 8(4)

F8 Article 13 U.K. Directive 2006/141/EC

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Textual Amendments

F8 Art. 13 omitted (31.12.2020) by virtue of The Nutrition (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1476), regs. 1(3), 8(5)

F9 Article 14 U.K. Entry into force and application

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Textual Amendments

F9 Art. 14 omitted (31.12.2020) by virtue of The Nutrition (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1476), regs. 1(3), 8(5)

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