S.L. 449.52 Art. 9Labelling and presentation of infant formulae and follow-on formulae.

(1)(a) Except as provided for in sub-regulation (2), the name under which infant formulae and follow-on formulae are sold shall be, respectively:

(i) in English: "infant formula" and "follow-on formula"

(ii) in Maltese: "formula tat-trabi" and "formula tal-prosegwiment";

(b) The name under which the products covered by regulation 4(2)(c) and (d) are sold shall be respectively: "infant formula" and "follow-on formula". However, the name of the products manufactured entirely from cows’ milk or goats’ milk proteins, shall be respectively: "infant milk" and "follow-on milk"..

(c) Without prejudice to paragraph (b), the list provided for in the Tenth Schedule specifies the names under which the products covered by regulation 4(2)(c) and

(d) are sold in all the European Community languages.

(2) The name under which infant formulae and follow-on formulae manufactured entirely from cows’ milk or goats’ milk proteins are sold shall be respectively:

(i) in English: "infant milk" and "follow-on milk"

(ii) in Maltese: "]alib tat-trabi" and "]alib tal-prosegwiment".

(3) The labelling shall bear, in addition to those provided for in regulation 5(1) of the Labelling, Presentation and Advertising of Foodstuffs Regulations, the following mandatory particulars in Maltese and, or English:

(a) in the case of infant formulae, a statement to the effect that the product is suitable for particular nutritional use by infants from birth when they are not breast fed;

(b) in the case of follow-on formulae, a statement to the effect that the product is suitable only for particular nutritional use by 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;

(c) in the case of infant formulae and follow-on formulae, the available energy value, expressed in kJ and kcal, and the content of proteins, carbohydrates and lipids, expressed in numerical form, per 100 ml of the product ready for use;

(d) in the case of infant formulae and follow-on formulae, the average quantity of each mineral substance and of each vitamin mentioned in the First and Second Schedules respectively, and where applicable of choline, inositol and carnitine, expressed in numerical form, per 100 ml of the product ready for use;

(e) in the case of infant formulae and follow-on formulae, instructions for appropriate preparation, storage and disposal of the product and a warning against the health hazards of inappropriate preparation and storage.

(4) The labelling may bear the following particulars:

(a) for infant formulae and follow-on formulae the average quantity of nutrients mentioned in the Third Schedule when such declaration is not covered by sub-regulation (3)(d), expressed in numerical form, per 100 ml of the product ready for use;

(b) for follow-on formulae in addition to numerical information, information on vitamins and minerals included in the Seventh Schedule, expressed as a percentage of the reference values given therein, per 100 ml of the product ready for use.

(5) The labelling of infant formulae and follow-on formulae shall be designed to provide the necessary information about the appropriate use of the products so as not to discourage breast feeding. The use of the terms "humanised", "maternalised", "adapted", or similar terms shall be prohibited.

(6) The labelling of infant formulae shall, in addition, bear the following mandatory particulars, preceded by the words "Important Notice" or their equivalent:

(a) statement concerning the superiority of breast feeding;

(b) 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.

(7) The labelling of infant formulae shall not include pictures of infants, nor shall it include other pictures or text which may idealise the use of the product. It may, however, have graphic representations for easy identification of the product and for illustrating methods of preparation.

(8) The labelling of infant formulae may bear nutrition and health claims only in the cases listed in the Fourth Schedule and in accordance with the conditions set out therein.

(9) Infant formulae and follow-on formulae shall be labelled in such a way that it enables consumers to make a clear distinction between such products so as to avoid any risk of confusion between infant formulae and follow-on formulae.

(10) The requirements, prohibitions and restrictions referred to in sub-regulations (5) to (9) shall also apply to:

(a) the presentation of the products concerned, in particular their shape, appearance or packaging, the packaging materials used, the way in which they are arranged and the setting in which they are displayed;

(b) advertising.