Amendment Of The Regulation On Infant Formulae And Follow-On Formulae

Original Language Title: Änderung der Verordnung über Säuglingsanfangsnahrung und Folgenahrung

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109. Regulation of the Federal Minister of Health, amending the Regulation on infant formulae and follow-on formulae

On the basis of § 6 (1) and (2) of the Food Safety and Consumer Protection Act-LMSVG, BGBl. I n ° 13/2006, as last amended by the Federal Law BGBl. I n ° 171/2013-with regard to § § 7 and 8 in agreement with the Federal Minister for Science, Research and Economy-decreed:

The Regulation on infant formulae and follow-on formulae, BGBl. II No 68/2008, shall be amended as follows:

1. In Section 4 (2), the word "Cow milk proteins" by the words "cow's milk or goat milk proteins" replaced.

2. § 4 (5) reads:

" (5) If follow-on formulae are produced from the protein hydrolysates defined in Appendix 2 Z 2.2. with a protein content between the minimum value and 0.56 g/100 kJ (2.25 g/100 kcal), the suitability of the follow-on formula for the particular nutritional use of to demonstrate to infants by appropriate studies carried out on the basis of generally accepted recommendations for the design and conduct of such studies; the relevant specifications of Appendix 6 are: "

3. The previous § 4 (5) becomes § 4 (6).

4. In § 7, second sentence, the word shall be: "Cow milk proteins" by the words "cow's milk or goat milk proteins" replaced.

5. In § 8, the previous Z 3 to 6 will become the Z 2 to 5.

6. § 15 reads:

" § 15. This Regulation implements the following directives of the European Union:

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Directive 2006 /141/EC on infant formulae and follow-on formulae, OJ L 327, 30.12.2006, p. No. OJ L 401, 30.12.2006,

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Directive 2013 /46/EU amending Directive 2006 /141/EC as regards protein requirements for infant formulae and follow-on formulae, OJ L 281, 23.11.2006, p. No. OJ L 230, 29.8.2013. "

7. In Appendix 1, Z. 2.1. in the heading, the words shall be: "on the basis of cow's milk proteins" by the words 'on the basis of cow ' s milk or goat ' s milk proteins' replaced.

8. In Appendix 1, Z 2.1. in footnote 1, the word shall be: "Cow milk proteins" by the words "cow's milk or goat milk proteins" replaced.

9. The heading in Appendix 1, Z 2.3. is:

" 2.3. Infant formulae on the basis of soy protein isolates, pure or in a mixture with cow's milk or goat milk proteins "

10. The heading in Appendix 1, Z 10.1. is:

" 10.1. Infant formulae based on cow ' s milk or goat ' s milk proteins or protein hydrolysates "

11. The heading in Appendix 1, Z 10.2. is:

" 10.2. Infant formulae on the basis of soy protein isolates, pure or as a mixture with cow's milk or goat milk proteins "

12. In Appendix 2, Z 2.1. in the heading, the word shall be: "Cow milk proteins" by the words "cow's milk or goat milk proteins" replaced.

13. The table in Appendix 2 Z 2.2. is:

" At least (1)

Maximum

0.45 g/100 kJ

(1.8 g/100 kcal)

0.8 g/100 kJ

(3.5 g/100 kcal)

(1) The follow-on formula produced from protein hydrolysates with a protein content between the minimum value and 0.56 g/100 kJ (2.25 g/100 kcal) must comply with the requirements of section 4 (5). "

14. The heading in Appendix 2 Z 2.3 reads:

" 2.3. Sequence phrases based on soy protein isolates, pure or in a mixture with cow's milk or goat ' s milk proteins "

15. The heading in Appendix 2 Z 8.1 is:

"8.1 follow-on phrases based on cow's milk or goat milk proteins or protein hydrolysates"

16. The title in Appendix 2, Z 8.2 is:

"8.2 follow-on formulae on the basis of soy protein isolates, pure or in a mixture with cow's milk or goat milk proteins"

17. The footnote in Appendix 3 Z 3 is:

" 1) L-Arginine and its hydrochloride may only be used for the production of infant formulae in accordance with § 4 (3) and follow-on formulae in accordance with § 4 (5). "

18. The heading in Annex 6 reads:

" Specification for protein content and source and protein processing in the production of infant formulae and follow-on formulae with a protein content of less than 0.56 g/100 kJ (2.25 g/100 kcal) based on whey protein hydrolysates Cow ' s milk protein "

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