S.I. No. 92/2014 - European Communities (Infant Formulae and Follow-on Formulae) (Amendment) Regulations 2014.
Notice of the making of this Statutory Instrument was published in | ||
“Iris Oifigiúil” of 21st February, 2014. | ||
I, JAMES REILLY, Minister for Health, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972) and for the purpose of giving effect to Commission Directive 2013/46/EU of 28 August 20131 , hereby make the following regulations: | ||
1. (1) These Regulations may be cited as the European Communities (Infant Formulae and Follow-on Formulae) (Amendment) Regulations 2014. | ||
(2) The Principal Regulations, the Regulations of 2009, the Regulations of 2013 and these Regulations may be cited together as the European Communities (Infant Formulae and Follow-on Formulae) Regulations 2007 to 2014. | ||
2. In these Regulations— | ||
“Principal Regulations” means the European Communities (Infant Formulae and Follow-on Formulae) Regulations 2007 ( S.I. No. 852 of 2007 ); | ||
“Regulations of 2009” means European Communities (Infant Formulae and Follow-on Formulae) (Amendment) Regulations 2009 ( S.I. No. 209 of 2009 ); | ||
“Regulations of 2013” means European Communities (Infant Formulae and Follow-on Formulae) (Amendment) Regulations 2013 ( S.I. No. 384 of 2013 ). | ||
3. Regulation 2(1) (as amended by Regulation 3 of the Regulations of 2013) of the Principal Regulations is amended by substituting for the definition of “Directive 2006/141/EC” the following: | ||
“‘Directive 2006/141/EC’ means Commission Directive 2006/141/EC of 22 December 20062 , as amended by Commission Regulation (EC) No. 1243/2008 of 12 December 20083 , Commission Directive 2013/26/EU of 8 February 20134 and Commission Directive 2013/46/EU of 28 August 20131;”. | ||
4. Regulation 3 of the Principal Regulations is amended— | ||
(a) in paragraph (3), by substituting “cows’ milk or goats’ milk proteins” for “cows’ milk proteins”, and | ||
(b) in paragraph (5), by substituting “cows’ milk or goats’ milk proteins” for “cows’ milk proteins”. | ||
5. Regulation 4(5) of the Principal Regulations is amended by substituting “cows’ milk or goats’ milk proteins” for “cows’ milk proteins”. | ||
6. Regulation 5 of the Principal Regulations is amended— | ||
(a) in paragraph (3), by substituting “Subject to paragraph 3A, follow-on formulae” for “Follow-on formulae”, and | ||
(b) by inserting after paragraph (3) the following paragraph: | ||
“(3A) In the case of follow-on formulae manufactured from protein hydrolysates defined in point 2.2 of Schedule 2 with a protein content between the minimum and 0.56g/100 kJ (2.25g/100 kcal): | ||
(a) 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 | ||
(b) shall be in accordance with the appropriate specifications set out in Schedule 6”. | ||
7. Schedule 1 to the Principal Regulations is amended— | ||
(a) in point 2.1— | ||
(i) in the title, by substituting “cows’ milk or goats’ milk proteins” for “cows’ milk proteins”, and | ||
(ii) in footnote 1, by substituting “cows’ milk or goats’ milk proteins” for “cows’ milk proteins”, | ||
(b) in the title to point 2.3, by substituting “cows’ milk or goats’ milk proteins” for “cows’ milk proteins”, | ||
(c) in the title to point 10.1, by substituting “cows’ milk or goats’ milk proteins” for “cows’ milk proteins”, and | ||
(d) in the title to point 10.2, by substituting “cows’ milk or goats’ milk proteins” for “cows’ milk proteins”. | ||
8. Schedule 2 to the Principal Regulations is amended— | ||
(a) in the title to point 2.1, by substituting “cows’ milk or goats’ milk proteins” for “cows’ milk proteins”, | ||
(b) in point 2.2— | ||
(i) by substituting for the maximum and minimum values the following: | ||
“Minimum(1) 0.45 g/100 kJ (1.8 g/100 kcal) | ||
Maximum 0.8 g/100 kJ (3.5 g/100 kcal)”, and | ||
(ii) by inserting after the maximum and minimum values the following footnote: | ||
“(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 Regulation 5(3A).” | ||
(c) in the title to point 2.3, by substituting “cows’ milk or goats’ milk proteins” for “cows’ milk proteins”, | ||
(d) in the title to point 8.1, by substituting “cows’ milk or goats’ milk proteins” for “cows’ milk proteins”, and | ||
(e) in the title to point 8.2, by substituting “cows’ milk or goats’ milk proteins” for “cow’s milk proteins”. | ||
9. Point 3 of Schedule 3 (as amended by Regulation 3 (d) of the Regulations of 2009) to the Principal Regulations is amended by substituting for footnote 1 the following: | ||
“(1) L-arginine and its hydrochloride shall only be used in the manufacture of infant formulae referred to in Regulation 4(6) and follow-on formulae referred to in Regulation 5(3A)”. | ||
10. The title to Schedule 6 to the Principal Regulations is amended by inserting “INFANT FORMUALE AND FOLLOW-ON FORMULAE” for “INFANT FORMULAE”. | ||
| ||
GIVEN under my Official Seal, | ||
11 February 2014. | ||
JAMES REILLY, | ||
Minister for Health. | ||
EXPLANATORY NOTE | ||
(This note is not part of the Instrument and does not purport to be a legal interpretation). | ||
These Regulations transpose into Irish law Commission Directive 2013/46/EU of 28 August 2013 amending Directive 2006/141/EC with regard to the protein requirements for infant formulae and follow-on formulae. | ||
These Regulations amend the European Communities (Infant Formulae and Follow-on Formulae) Regulations 2007 ( S.I. No. 852 of 2007 ) in the manner specified in these Regulations. | ||
These Regulations may be cited as the European Communities (Infant Formulae and Follow-on Formulae) (Amendment) Regulations 2014. | ||
1 OJ No. L. 230, 29.8.2013, p.16. 2 OJ No. L. 401, 30.12.2006, p. 1. |
