Infant Formulae and Follow-on Formulae

L.N. 75 of 2014

FOOD SAFETY ACT

(CAP. 449)

Infant Formulae and Follow-on Formulae

(Amendment) Regulations, 2014

IN exercise of the powers conferred by article 10 of the Food

Safety Act, the Minister for Social Policy has made the following

regulations:-

(1) The title of these regulations is the Infant Formulae

and Follow-on Formulae (Amendment) Regulations, 2014, and these

regulations shall be read and construed as one with the Infant

Formulae and Follow-on Formulae Regulations, hereinafter referred

to as "the principal regulations".

(2) These regulations shall be deemed to have come into force

on the 28 February, 2014.

These regulations implement the provisions of

Commission Directive 2013/46/EU of 28 August 2013 amending

Directive 2006/141 with regard to protein requirements for infant

formulae and follow-on formulae.

Regulation 7 of the principal regulations shall be amended

as follows

(a)

in sub-regulation (1) thereof, for the paragraph

starting with the words "In the case of infant formulae

manufactured from cows’ milk proteins" and ending with the

words "expert guidance on the design and conduct of such

studies.", there shall be substituted the following

"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."; and

(b) in sub-regulation (2) thereof, immediately after the

words "set out in the Fifth Schedule.", there shall be added the

following new paragraph

"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.".

Regulation 9 of the principal regulations shall be amended Amends

regulation 9 of

as follows

the principal

regulations.

(a)

paragraph (b) of sub-regulation (1) thereof shall be

substituted by the following

"(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"."; and

(b)

in sub-regulation (2) thereof, for the words

"The name under which infant formulae and

follow-on formulae manufactured entirely from cows’

milk proteins are sold, shall be respectively:",

there shall be substituted the words

"The name under which infant formulae and

follow-on formulae manufactured entirely from cows’

milk or goats’ milk proteins are sold shall be

respectively:".

The First Schedule to the principal regulations shall be Amends the

First Schedule

amended as follows

to the principal

regulations.

(a)

for the heading of point 2.1 thereof, there shall be

substituted the following

"2.1 Infant formulae manufactured from cows’

milk or goats’ milk proteins";

(b) for footnote 1 of point 2.1 thereof, there shall be

substituted the following

"(1) Infant formulae manufactured from cows’

milk or goats’ milk protein with a protein content between

the minimum and 0,5 g/100 kJ (2 g/100 kcal) shall be in

accordance with the second subparagraph of regulation

7(1).";

(c)

for the heading of point 2.3 thereof, there shall be

substituted the following

"2.3 Infant formulae manufactured from soya

protein isolates, alone or in a mixture with cows’ milk or

goats’ milk proteins.";

(d) for the heading of point 10.1 thereof, there shall be

substituted the following

"10.1 Infant formulae manufactured from cows’

milk or goats’ milk proteins or protein hydrolysates."; and

(e)

for the heading of point 10.2 thereof, there shall be

substituted the following

"10.2 Infant formulae manufactured from soya

protein isolates, alone or in a mixture with cows’ milk or

goats’ milk proteins.".

The Second Schedule to the principal regulations shall be

amended as follows

(a)

for the heading of point 2.1 thereof, there shall be

substituted the following

"2.1 Follow-on formulae manufactured

from

cows’ milk or goats’ milk proteins.";

(b) for the table under point 2.2 thereof, there shall be

substituted the following

Minimum (1)

Maximum

0,45 g/100 kJ

0,8 g/100 kJ

(1,8 g/100 kcal)

(3,5 g/100 kcal)

(1) Follow-on formulae manufactured from protein hydrolysates with a

protein content between the minimum and 0,56 g/100 kJ (2,25 g/100 kcal)

";

shall be in accordance with the second subparagraph of regulation 7(2).

(c)

for the heading of point 2.3 thereof, there shall be

substituted the following

"2.3 Follow-on formulae manufactured from soya

protein isolates, alone or in a mixture with cows’ milk or

goats’ milk proteins.";

(d) for the heading of point 8.1 thereof, there shall be

substituted the following

"8.1 Follow-on formulae manufactured from

cows’ milk or goats’ milk proteins or protein

hydrolysates." and

(e)

for the heading of point 8.2 thereof, there shall be

substituted the following

"8.2 Follow-on formulae manufactured from soya

protein isolates, alone or in a mixture with cows’ milk or

goats’ milk proteins.".

The Third Schedule to the principal regulations shall be Amends the

Third Schedule

amended as follows

to the principal

regulations.

(a)

in the table relating to point 3 "Amino acids and

other nitrogen compounds" thereof, immediately before the

item "L-cystine and its hydrochloride" there shall be added the

following new item

"L-arginine and its hydrochloride (1) "; and

(b) immediately at the end of the said table, there shall

be added the following corresponding footnote

" (1) L-arginine and its hydrochloride shall only be

used in the manufacture of infant formulae referred to in

the third subparagraph of regulation 7(1) and follow-on

formulae referred to in the second subparagraph of

regulation 7(2).".

For the heading of the Sixth Schedule, there shall be Amends the

Sixth Schedule

substituted the following

to the principal

regulations.

"Specification for the protein content and source and the

processing of protein used in the manufacture of infant formulae

and follow-on formulae with a protein content less than 0,56 g/

100 kJ (2,25 g/100 kcal) manufactured from hydrolysates of

whey proteins derived from cows’ milk protein’.".

€0.45