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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)
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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.
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