S.I. No. 466/2025 - European Union (Food Intended for Infants and Young Children, Food for Special Medical Purposes, and Total Diet Replacement for Weight Control) (Amendment) (No. 2) Regulations 2025


Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 7th October, 2025.

I, JENNIFER CARROLL MACNEILL, 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 further effect to Regulation (EU) No. 609/2013 of the European Parliament and of the Council of 12 June 20131 and effect to Commission Delegated Regulation (EU) 2025/1735 of 4 June 20252 , hereby make the following regulations:

1. (1) These Regulations may be cited as the European Union (Food Intended for Infants and Young Children, Food for Special Medical Purposes, and Total Diet Replacement for Weight Control) (Amendment) (No. 2) Regulations 2025.

(2) The Principal Regulations, the European Union (Food Intended for Infants and Young Children, Food for Special Medical Purposes, and Total Diet Replacement for Weight Control) (Amendment) Regulations 2022 ( S.I. No. 111 of 2022 ), the European Union (Food Intended for Infants and Young Children, Food for Special Medical Purposes, and Total Diet Replacement for Weight Control) (Amendment) Regulations 2023 ( S.I. No. 490 of 2023 ), the European Union (Food Intended for Infants and Young Children, Food for Special Medical Purposes, and Total Diet Replacement for Weight Control) (Amendment) Regulations 2024 ( S.I. No. 411 of 2024 ), the Regulations of 2025 and these Regulations may be cited together as the European Union (Food Intended for Infants and Young Children, Food for Special Medical Purposes, and Total Diet Replacement for Weight Control) Regulations 2019 to 2025.

2. In these Regulations –

“Principal Regulations” means the European Union (Food Intended for Infants and Young Children, Food for Special Medical Purposes, and Total Diet Replacement for Weight Control) Regulations 2019 ( S.I. No. 425 of 2019 );

“Regulations of 2025” means the European Union (Food Intended for Infants and Young Children, Food for Special Medical Purposes, and Total Diet Replacement for Weight Control) (Amendment) Regulations 2025 ( S.I. No. 128 of 2025 ).

3. Regulation 2(1) of the Principal Regulations (as last amended by Regulation 3 of the Regulations of 2025) is hereby amended–

(a) by substituting for the definition of “EU Regulation 609/2013” the following:

“‘EU Regulation 609/2013’ means Regulation (EU) No. 609/2013 of the European Parliament and of the Council of 12 June 20131 as amended by Commission Delegated Regulation (EU) 2017/1091 of 10 April 20173 , Commission Delegated Regulation (EU) 2021/571 of 20 January 20214 , Commission Delegated Regulation (EU) 2023/439 of 16 December 20225 and Commission Delegated Regulation (EU) 2024/2791 of 29 January 20246 and Commission Delegated Regulation (EU) 2025/1735 of 4 June 20252 ,”, and

(b) by substituting for the definition of “Union List” the following:

“‘Union list’ means the Union list annexed to EU Regulation 609/2013 as amended by Commission Delegated Regulation (EU) 2017/1091 of 10 April 20173 , Commission Delegated Regulation (EU) 2021/571 of 20 January 20214 , Commission Delegated Regulation (EU) 2023/439 of 16 December 20225 , Commission Delegated Regulation (EU) 2024/2791 of 29 January 20246 and Commission Delegated Regulation (EU) 2025/1735 of 4 June 20252 and which lists the various substances that may be added to one or more of the categories of food referred to in Regulation 3.”.

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GIVEN under my Official Seal,

1 October, 2025.

JENNIFER CARROLL MACNEILL,

Minister for Health.

EXPLANATORY NOTE

(This note is not part of the Instrument and does not purport to be a legal interpretation.)

These Regulations give effect to Commission Delegated Regulation (EU) 2025/1735 of 4 June 2025 amending the Annex to Regulation (EU) No 609/2013 of the European Parliament and of the Council to allow the use of monosodium salt of L-5-methyltetrahydrofolic acid as a source of folate in infant formula and follow-on formula, processed cereal-based food and baby food, total diet replacement for weight control and in food for special medical purposes.

These Regulations amend the European Union (Food Intended for Infants and Young Children, Food for Special Medical Purposes, and Total Diet Replacement for Weight Control) Regulations 2019 ( S.I. No. 425 of 2019 ) in the manner specified in these Regulations.

These Regulations may be cited as the European Union (Food Intended for Infants and Young Children, Food for Special Medical Purposes, and Total Diet Replacement for Weight Control) (Amendment) (No. 2) Regulations 2025.

1 OJ No. L 181, 29.6.2013, p. 35.

2 OJ L, 2025/1735, 12.8.2025.

1 OJ No. L 181, 29.6.2013, p. 35.

3 OJ No. L 158, 21.6.2017, p. 5.

4 OJ No. L 120, 8.4.2021, p. 1.

5 OJ No. L 64, 1.3.2023, p. 1.

6 OJ L, 2024/2791, 31.10.2024.

2 OJ L, 2025/1735, 12.8.2025.

3 OJ No. L 158, 21.6.2017, p. 5.

4 OJ No. L 120, 8.4.2021, p. 1.

5 OJ No. L 64, 1.3.2023, p. 1.

6 OJ L, 2024/2791, 31.10.2024.

2 OJ L, 2025/1735, 12.8.2025.