S.L. 449.52 Art. 7Compositional criteria.

(1) Infant formulae shall comply with the compositional criteria set out in the First Schedule taking into account the specifications of the Fifth Schedule.

In the case of infant formulae manufactured from cows’ milk or goats’ milk proteins defined in point 2.1 of the First Schedule with a protein content between the minimum and 0,5 g/ 100 kJ (2 g/100 kcal), the suitability of the infant formula for the particular nutritional use by infants shall be demonstrated through appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies. In the case of infant formulae manufactured from protein hydrolysates defined in point 2.2 of the First Schedule with a protein content between the minimum and 0,56 g/100 kJ (2,25g/100 kcal), the suitability of the infant formula for the particular nutritional use by infants shall be demonstrated through appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies and shall be in accordance with the appropriate specifications set out in the Sixth Schedule.

(2) Follow-on formulae shall comply with the compositional criteria set out in the Second Schedule taking into account the specifications set out in the Fifth Schedule. In the case of follow-on formulae manufactured from protein hydrolysates defined in point 2.2 of the Second Schedule with a protein content between the minimum and 0,56 g/100 kJ (2,25 g/100 kcal), the suitability of the follow-on formula for the particular nutritional use by infants shall be demonstrated through appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies and shall be in accordance with the appropriate specifications set out in the Sixth Schedule.

(3) In order to make infant formulae and follow-on formulae ready for use, nothing more shall be required, as the case may be, than the addition of water.

(4) Only the substances listed in the Third Schedule may be used in the manufacture of infant formulae and follow-on formulae in order to satisfy the requirements on:

(a) mineral substances;

(b) vitamins;

(c) amino acids and other nitrogen compounds;

(d) other substances having a particular nutritional purpose.

(5) Infant formulae and follow-on formulae shall not contain any substance in such quantity as to endanger the health of infants and young children.

(6) Purity criteria for substances, concerning the use of substances listed in the Third Schedule, in the manufacture of foodstuffs for purposes other than those covered by this regulation, shall apply.

(7) For those substances for which no purity criteria have been provided for in Community legislation, generally acceptable purity criteria recommended by international bodies shall apply until the adoption of such criteria at Community level. However, national rules setting stricter purity criteria than those recommended by international bodies may be maintained.

(8) Infant formulae and follow-on formulae shall not contain residues of individual pesticides at levels exceeding 0,01 mg/kg of the product as proposed ready for consumption or as reconstituted according to the instructions of the manufacturer. Analytical methods for determining the levels of pesticide residues shall be generally acceptable standardised methods.

(9) The pesticides listed in the Eight Schedule shall not be used in agricultural products intended for the production of infant formulae and follow-on formulae.

However, for the purpose of controls:

(a) pesticides listed in Table 1 of the Eighth Schedule are considered not to have been used if their residues do not exceed a level of 0,003 mg/kg. This level, which is considered to be the limit of quantification of the analytical methods, shall be kept under regular review in the light of technical progress;

(b) pesticides listed in Table 2 of the Eighth Schedule are considered not to have been used if their residues do not exceed a level of 0,003 mg/kg. This level shall be kept under regular review in the light of data on environmental contamination.

(10) By way of derogation from sub-regulation (8), for the pesticides listed in the Ninth Schedule, the maximum residue levels specified therein shall apply.

(11) The levels referred to in sub-regulations (9) and (10) shall apply to the products as proposed ready for consumption or as reconstituted according to the instructions of the manufacturers.