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)Text with EEA relevance

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

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.

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.

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.

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.

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.

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.

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.

For the purposes of this Article, ‘residue’ means the residue of an active substance as referred to in Article 2(2) of Regulation (EC) No 1107/2009 used in a plant protection product as referred to in Article 2(1) of that Regulation, including metabolites and products resulting from the degradation or reaction of that active substance.

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.

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.

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.

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.

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.

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.