S.I. No. 315/2025 - European Union (Novel Foods) (Amendment) (No. 2) Regulations 2025

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 15th July, 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 Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017¹ , as amended by the Commission implementing acts specified in Part A of Schedule 1 to these Regulations, hereby make the following Regulations:

1. (1) These Regulations may be cited as the European Union (Novel Foods) (Amendment) (No. 2) Regulations 2025.

(2) The Principal Regulations, the European Union (Novel Foods) (Amendment) Regulations 2024 ( S.I. No. 159 of 2024 ), the Regulations of 2025 and these Regulations may be cited together as the European Union (Novel Foods) Regulations 2022 to 2025.

2. In these Regulations –

“Principal Regulations” means the European Union (Novel Foods) Regulations 2022 ( S.I. No. 253 of 2022 );

“Regulations of 2025” means the European Union (Novel Foods) (Amendment) Regulations 2025 ( S.I. No. 40 of 2025 ).

3. Part A of Schedule 1 (as amended by Regulation 5 of the Regulations of 2025) of the Principal Regulations is substituted by the following:

“Schedule 1 Part A

1. Commission Implementing Regulation (EU) 2018/460 of 20 March 2018²

2. Commission Implementing Regulation (EU) 2018/461 of 20 March 2018³

3. Commission Implementing Regulation (EU) 2018/462 of 20 March 2018⁴

4. Commission Implementing Regulation (EU) 2018/469 of 21 March 2018⁵

5. Commission Implementing Regulation (EU) 2018/991 of 12 July 2018⁶

6. Commission Implementing Regulation (EU) 2018/1011 of 17 July 2018⁷

7. Commission Implementing Regulation (EU) 2018/1018 of 18 July 2018⁸

8. Commission Implementing Regulation (EU) 2018/1023 of 23 July 2018⁹

9. Commission Implementing Regulation (EU) 2018/1032 of 20 July 2018¹⁰

10. Commission Implementing Regulation (EU) 2018/1122 of 10 August 2018¹¹

11. Commission Implementing Regulation (EU) 2018/1123 of 10 August 2018¹²

12. Commission Implementing Regulation (EU) 2018/1132 of 13 August 2018¹³

13. Commission Implementing Regulation (EU) 2018/1133 of 13 August 2018¹⁴

14. Commission Implementing Regulation (EU) 2018/1293 of 26 September 2018¹⁵

15. Commission Implementing Regulation (EU) 2018/1631 of 30 October 2018¹⁶

16. Commission Implementing Regulation (EU) 2018/1632 of 30 October 2018¹⁷

17. Commission Implementing Regulation (EU) 2018/1633 of 30 October 2018¹⁸

18. Commission Implementing Regulation (EU) 2018/1647 of 31 October 2018¹⁹

19. Commission Implementing Regulation (EU) 2018/1648 of 29 October 2018²⁰

20. Commission Implementing Regulation (EU) 2018/1991 of 13 December 2018²¹

21. Commission Implementing Regulation (EU) 2018/2016 of 18 December 2018²²

22. Commission Implementing Regulation (EU) 2018/2017 of 18 December 2018²³

23. Commission Implementing Regulation (EU) 2019/108 of 24 January 2019²⁴

24. Commission Implementing Regulation (EU) 2019/109 of 24 January 2019²⁵

25. Commission Implementing Regulation (EU) 2019/110 of 24 January 2019²⁶

26. Commission Implementing Regulation (EU) 2019/387 of 11 March 2019²⁷

27. Commission Implementing Regulation (EU) 2019/388 of 11 March 2019²⁸

28. Commission Implementing Regulation (EU) 2019/456 of 20 March 2019²⁹

29. Commission Implementing Regulation (EU) 2019/506 of 26 March 2019³⁰

30. Commission Implementing Regulation (EU) 2019/760 of 13 May 2019³¹

31. Commission Implementing Regulation (EU) 2019/1272 of 29 July 2019³²

32. Commission Implementing Regulation (EU) 2019/1294 of 1 August 2019³³

33. Commission Implementing Regulation (EU) 2019/1314 of 2 August 2019³⁴

34. Commission Implementing Regulation (EU) 2019/1686 of 8 October 2019³⁵

35. Commission Implementing Regulation (EU) 2019/1976 of 25 November 2019³⁶

36. Commission Implementing Regulation (EU) 2019/1979 of 26 November 2019³⁷

37. Commission Implementing Regulation (EU) 2019/2165 of 17 December 2019³⁸

38. Commission Implementing Regulation (EU) 2020/16 of 10 January 2020³⁹

39. Commission Implementing Regulation (EU) 2020/24 of 13 January 2020⁴⁰

40. Commission Implementing Regulation (EU) 2020/206 of 14 February 2020⁴¹

41. Commission Implementing Regulation (EU) 2020/443 of 25 March 2020⁴²

42. Commission Implementing Regulation (EU) 2020/478 of 1 April 2020⁴³

43. Commission Implementing Regulation (EU) 2020/484 of 2 April 2020⁴⁴

44. Commission Implementing Regulation (EU) 2020/500 of 6 April 2020⁴⁵

45. Commission Implementing Regulation (EU) 2020/916 of 1 July 2020⁴⁶

46. Commission Implementing Regulation (EU) 2020/917 of 1 July 2020⁴⁷

47. Commission Implementing Regulation (EU) 2020/973 of 6 July 2020⁴⁸

48. Commission Implementing Regulation (EU) 2020/1163 of 6 August 2020⁴⁹

49. Commission Implementing Regulation (EU) 2020/1559 of 26 October 2020⁵⁰

50. Commission Implementing Regulation (EU) 2020/1634 of 4 November 2020⁵¹

51. Commission Implementing Regulation (EU) 2020/1820 of 2 December 2020⁵²

52. Commission Implementing Regulation (EU) 2020/1821 of 2 December 2020⁵³

53. Commission Implementing Regulation (EU) 2020/1822 of 2 December 2020⁵⁴

54. Commission Implementing Regulation (EU) 2020/1993 of 4 December 2020⁵⁵

55. Commission Implementing Regulation (EU) 2021/50 of 22 January 2021⁵⁶

56. Commission Implementing Regulation (EU) 2021/51 of 22 January 2021⁵⁷

57. Commission Implementing Regulation (EU) 2021/82 of 27 January 2021⁵⁸

58. Commission Implementing Regulation (EU) 2021/96 of 28 January 2021⁵⁹

59. Commission Implementing Regulation (EU) 2021/120 of 2 February 2021⁶⁰

60. Commission Implementing Regulation (EU) 2021/668 of 23 April 2021⁶¹

61. Commission Implementing Regulation (EU) 2021/670 of 23 April 2021⁶²

62. Commission Implementing Regulation (EU) 2021/882 of 1 June 2021⁶³

63. Commission Implementing Regulation (EU) 2021/900 of 3 June 2021⁶⁴

64. Commission Implementing Regulation (EU) 2021/912 of 4 June 2021⁶⁵

65. Commission Implementing Regulation (EU) 2021/1318 of 9 August 2021⁶⁶

66. Commission Implementing Regulation (EU) 2021/1319 of 9 August 2021⁶⁷

67. Commission Implementing Regulation (EU) 2021/1326 of 10 August 2021⁶⁸

68. Commission Implementing Regulation (EU) 2021/1377 of 19 August 2021⁶⁹

69. Commission Implementing Regulation (EU) 2021/1974 of 12 November 2021⁷⁰

70. Commission Implementing Regulation (EU) 2021/1975 of 12 November 2021⁷¹

71. Commission Implementing Regulation (EU) 2021/2029 of 19 November 2021⁷²

72. Commission Implementing Regulation (EU) 2021/2079 of 26 November 2021⁷³

73. Commission Implementing Regulation (EU) 2021/2129 of 2 December 2021⁷⁴

74. Commission Implementing Regulation (EU) 2021/2191 of 10 December 2021⁷⁵

75. Commission Implementing Regulation (EU) 2022/47 of 13 January 2022⁷⁶

76. Commission Implementing Regulation (EU) 2022/168 of 8 February 2022⁷⁷

77. Commission Implementing Regulation (EU) 2022/169 of 8 February 2022⁷⁸

78. Commission Implementing Regulation (EU) 2022/187 of 10 February 2022⁷⁹

79. Commission Implementing Regulation (EU) 2022/188 of 10 February 2022⁸⁰

80. Commission Implementing Regulation (EU) 2022/196 of 11 February 2022⁸¹

81. Commission Implementing Regulation (EU) 2022/202 of 14 February 2022⁸²

82. Commission Implementing Regulation (EU) 2022/672 of 22 April 2022⁸³

83. Commission Implementing Regulation (EU) 2022/673 of 22 April 2022⁸⁴

84. Commission Implementing Regulation (EU) 2022/684 of 28 April 2022⁸⁵

85. Commission Implementing Regulation (EU) 2022/961 of 20 June 2022⁸⁶

86. Commission Implementing Regulation (EU) 2022/965 of 21 June 2022⁸⁷

87. Commission Implementing Regulation (EU) 2022/966 of 21 June 2022⁸⁸

88. Commission Implementing Regulation (EU) 2022/1160 of 5 July 2022⁸⁹

89. Commission Implementing Regulation (EU) 2022/1365 of 4 August 2022⁹⁰

90. Commission Implementing Regulation (EU) 2022/1373 of 5 August 2022⁹¹

91. Commission Implementing Regulation (EU) 2022/1381 of 8 August 2022⁹²

92. Commission Implementing Regulation (EU) 2022/2534 of 21 December 2022⁹³

93. Commission Implementing Regulation (EU) 2022/2535 of 21 December 2022⁹⁴

94. Commission Implementing Regulation (EU) 2023/4 of 3 January 2023⁹⁵

95. Commission Implementing Regulation (EU) 2023/5 of 3 January 2023⁹⁶

96. Commission Implementing Regulation (EU) 2023/6 of 3 January 2023⁹⁷

97. Commission Implementing Regulation (EU) 2023/7 of 3 January 2023⁹⁸

98. Commission Implementing Regulation (EU) 2023/52 of 4 January 2023⁹⁹

99. Commission Implementing Regulation (EU) 2023/58 of 5 January 2023¹⁰⁰

100. Commission Implementing Regulation (EU) 2023/65 of 6 January 2023¹⁰¹

101. Commission Implementing Regulation (EU) 2023/113 of 16 January 2023¹⁰²

102. Commission Implementing Regulation (EU) 2023/267 of 8 February 2023¹⁰³

103. Commission Implementing Regulation (EU) 2023/463 of 3 March 2023¹⁰⁴

104. Commission Implementing Regulation (EU) 2023/652 of 20 March 2023¹⁰⁵

105. Commission Implementing Regulation (EU) 2023/667 of 22 March 2023¹⁰⁶

106. Commission Implementing Regulation (EU) 2023/859 of 25 April 2023¹⁰⁷

107. Commission Implementing Regulation (EU) 2023/931 of 8 May 2023¹⁰⁸

108. Commission Implementing Regulation (EU) 2023/937 of 10 May 2023¹⁰⁹

109. Commission Implementing Regulation (EU) 2023/938 of 10 May 2023¹¹⁰

110. Commission Implementing Regulation (EU) 2023/943 of 11 May 2023¹¹¹

111. Commission Implementing Regulation (EU) 2023/948 of 12 May 2023¹¹²

112. Commission Implementing Regulation (EU) 2023/949 of 12 May 2023¹¹³

113. Commission Implementing Regulation (EU) 2023/950 of 12 May 2023¹¹⁴

114. Commission Implementing Regulation (EU) 2023/951 of 12 May 2023¹¹⁵

115. Commission Implementing Regulation (EU) 2023/961 of 12 May 2023¹¹⁶

116. Commission Implementing Regulation (EU) 2023/972 of 10 May 2023¹¹⁷

117. Commission Implementing Regulation (EU) 2023/1581 of 1 August 2023¹¹⁸

118. Commission Implementing Regulation (EU) 2023/1582 of 1 August 2023¹¹⁹

119. Commission Implementing Regulation (EU) 2023/1583 of 1 August 2023¹²⁰

120. Commission Implementing Regulation (EU) 2023/2210 of 20 October 2023¹²¹

121. Commission Implementing Regulation (EU) 2023/2214 of 23 October 2023¹²²

122. Commission Implementing Regulation (EU) 2023/2215 of 23 October 2023¹²³

123. Commission Implementing Regulation (EU) 2023/2847 of 20 December 2023¹²⁴

124. Commission Implementing Regulation (EU) 2023/2851 of 20 December 2023¹²⁵

125. Commission Implementing Regulation (EU) 2023/2852 of 20 December 2023¹²⁶

126. Commission Implementing Regulation (EU) 2024/1023 of 8 April 2024¹²⁷

127. Commission Implementing Regulation (EU) 2024/1026 of 8 April 2024¹²⁸

128. Commission Implementing Regulation (EU) 2024/1027 of 8 April 2024¹²⁹

129. Commission Implementing Regulation (EU) 2024/1037 of 9 April 2024¹³⁰

130. Commission Implementing Regulation (EU) 2024/1046 of 9 April 2024¹³¹

131. Commission Implementing Regulation (EU) 2024/1047 of 9 April 2024¹³²

132. Commission Implementing Regulation (EU) 2024/1048 of 9 April 2024¹³³

133. Commission Implementing Regulation (EU) 2024/1052 of 10 April 2024¹³⁴

134. Commission Implementing Regulation (EU) 2024/1611 of 6 June 2024¹³⁵

135. Commission Implementing Regulation (EU) 2024/2036 of 29 July 2024¹³⁶

136. Commission Implementing Regulation (EU) 2024/2044 of 29 July 2024¹³⁷

137. Commission Implementing Regulation (EU) 2024/2046 of 29 July 2024¹³⁸

138. Commission Implementing Regulation (EU) 2024/2047 of 29 July 2024¹³⁹

139. Commission Implementing Regulation (EU) 2024/2048 of 29 July 2024¹⁴⁰

140. Commission Implementing Regulation (EU) 2024/2049 of 30 July 2024¹⁴¹

141. Commission Implementing Regulation (EU) 2024/2061 of 30 July 2024¹⁴²

142. Commission Implementing Regulation (EU) 2024/2062 of 30 July 2024¹⁴³

143. Commission Implementing Regulation (EU) 2024/2090 of 29 July 2024¹⁴⁴

144. Commission Implementing Regulation (EU) 2024/2101 of 30 July 2024¹⁴⁵

145. Commission Implementing Regulation (EU) 2024/2102 of 30 July 2024¹⁴⁶

146. Commission Implementing Regulation (EU) 2024/2682 of 16 October 2024¹⁴⁷

147. Commission Implementing Regulation (EU) 2024/2694 of 17 October 2024¹⁴⁸ ”.

GIVEN under my Official Seal,

10 July, 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 further effect to Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 which establishes the Union List of Novel Foods as amended by the Commission Implementing Regulations specified in the Schedule to these Regulations.

These Regulations may be cited as the European Union (Novel Foods) (Amendment) (No. 2) Regulations 2025.

These Regulations amend the European Union (Novel Foods) Regulations 2022 ( S.I. No. 253 of 2022 ) in the manner specified in these Regulations and can be cited together with all previous amending instruments as the European Union (Novel Foods) Regulations 2022 to 2025.

1 OJ No. L 351, 30.12.2017, p. 72.

2 OJ No. L 78, 21.3.2018, p. 2.

3 OJ No. L 78, 21.3.2018, p. 7.

4 OJ No. L 78, 21.3.2018, p. 11.

5 OJ No. L 79, 22.3.2018, p. 11.

6 OJ No. L 177, 13.7.2018, p. 9.

7 OJ No. L 181, 18.7.2018, p. 4.

8 OJ No. L 183, 19.7.2018, p. 9.

9 OJ No. L 187, 24.7.2018, p. 1.

10 OJ No. L 185, 23.7.2018, p. 9.

11 OJ No. L 204, 13.8.2018, p. 36.

12 OJ No. L 204, 13.8.2018, p. 41.

13 OJ No. L 205, 14.8.2018, p. 15.

14 OJ No. L 205, 14.8.2018, p. 18.

15 OJ No. L 243, 27.9.2018, p. 2.

16 OJ No. L 272, 31.10.2018, p. 17.

17 OJ No. L 272, 31.10.2018, p. 23.

18 OJ No. L 272, 31.10.2018, p. 29.

19 OJ No. L 274, 5.11.2018, p. 51.

20 OJ No. L 275, 6.11.2018, p. 1.

21 OJ No. L 320, 17.12.2018, p. 22.

22 OJ No. L 323, 19.12.2018, p. 1.

23 OJ No. L 323, 19.12.2018, p. 4.

24 OJ No. L 23, 25.1.2019, p. 4.

25 OJ No. L 23, 25.1.2019, p. 7.

26 OJ No. L 23, 25.1.2019, p. 11.

27 OJ No. L 70, 12.3.2019, p. 17.

28 OJ No. L 70, 12.3.2019, p. 21.

29 OJ No. L 79, 21.3.2019, p. 13.

30 OJ No. L 85, 27.3.2019, p. 11.

31 OJ No. L 125, 14.5.2019, p. 13.

32 OJ No. L 201, 30.7.2019, p. 3.

33 OJ No. L 204, 2.8.2019, p. 16.

34 OJ No. L 205, 5.8.2019, p. 4.

35 OJ No. L 258, 9.10.2019, p. 13.

36 OJ No. L 308, 29.11.2019, p. 40.

37 OJ No. L 308, 29.11.2019, p. 62.

38 OJ No. L 328, 18.12.2019, p. 81.

39 OJ No. L 7, 13.1.2020, p. 6.

40 OJ No. L 8, 14.1.2020, p. 12.

41 OJ No. L 43, 17.2.2020, p. 66.

42 OJ No. L 92, 26.3.2020, p. 7.

43 OJ No. L 102, 2.4.2020, p. 1.

44 OJ No. L 103, 3.4.2020, p. 3.

45 OJ No. L 109, 7.4.2020, p. 2.

46 OJ No. L 209, 2.7.2020, p. 6.

47 OJ No. L 209, 2.7.2020, p. 10.

48 OJ No. L 215, 7.7.2020, p. 7.

49 OJ No. L 258, 7.8.2020, p. 1.

50 OJ No. L 357, 27.10.2020, p. 7.

51 OJ No. L 367, 5.11.2020, p. 39.

52 OJ No. L 406, 3.12.2020, p. 29.

53 OJ No. L 406, 3.12.2020, p. 34.

54 OJ No. L 406, 3.12.2020, p. 39.

55 OJ No. L 410, 7.12.2020, p. 62.

56 OJ No. L 23, 25.1.2021, p. 7.

57 OJ No. L 23, 25.1.2021, p. 10.

58 OJ No. L 29, 28.1.2021, p. 16.

59 OJ No. L 31, 29.1.2021, p. 201.

60 OJ No. L 37, 3.2.2021, p. 1.

61 OJ No. L 141, 26.4.2021, p. 3.

62 OJ No. L 141, 26.4.2021, p. 14.

63 OJ No. L 194, 2.6.2021, p. 16.

64 OJ No. L 197, 4.6.2021, p. 71.

65 OJ No. L 199, 7.6.2021, p. 10.

66 OJ No. L 286, 10.8.2021, p. 5.

67 OJ No. L 286, 10.8.2021, p. 12.

68 OJ No. L 288, 11.8.2021, p. 24.

69 OJ No. L 297, 20.8.2021, p. 20.

70 OJ No. L 402, 15.11.2021, p. 5.

71 OJ No. L 402, 15.11.2021, p.10.

72 OJ No. L 415, 22.11.2021, p. 9.

73 OJ No. L 426, 29.11.2021, p. 16.

74 OJ No. L 432, 3.12.2021, p. 13.

75 OJ No. L 445, 13.12.2021, p. 1.

76 OJ No. L 9, 14.1.2022, p. 29.

77 OJ No. L 28, 9.2.2022, p. 5.

78 OJ No. L 28, 9.2.2022, p. 10.

79 OJ No. L 30, 11.2.2022, p. 102.

80 OJ No. L 30, 11.2.2022, p. 108.

81 OJ No. L 31, 14.2.2022, p. 46.

82 OJ No. L 33, 15.2.2022, p. 41.

83 OJ No. L 122, 25.4.2022, p. 24.

84 OJ No. L 122, 25.4.2022, p. 27.

85 OJ No. L 126, 29.4.2022, p. 10.

86 OJ No. L 165, 21.6.2022, p. 41.

87 OJ No. L 166, 22.6.2022, p. 118.

88 OJ No. L 166, 22.6.2022, p. 125.

89 OJ No. L 179, 6.7.2022, p. 25.

90 OJ No. L 205, 5.8.2022, p. 230.

91 OJ No. L 206, 8.8.2022, p. 28.

92 OJ No. L 207, 9.8.2022, p. 12.

93 OJ No. L 328, 22.12.2022, p. 85.

94 OJ No. L 328, 22.12.2022, p. 91.

95 OJ No. L 2, 4.1.2023, p. 3.

96 OJ No. L 2, 4.1.2023, p. 9.

97 OJ No. L 2, 4.1.2023, p. 16.

98 OJ No. L 2, 4.1.2023, p. 21.

99 OJ No. L 3, 5.1.2023, p. 1.

100 OJ No. L 5, 6.1.2023, p. 10.

101 OJ No. L 6, 9.1.2023, p. 1.

102 OJ No. L 15, 17.1.2023, p. 1.

103 OJ No. L 39, 9.2.2023, p. 1.

104 OJ No. L 68, 6.3.2023, p. 32.

105 OJ No. L 81, 21.3.2023, p. 23.

106 OJ No. L 84, 23.3.2023, p. 3.

107 OJ No. L 111, 26.4.2023, p. 17.

108 OJ No. L 124, 10.5.2023, p. 1.

109 OJ No. L 125, 11.5.2023, p. 12.

110 OJ No. L 125, 11.5.2023, p. 16.

111 OJ No. L 126, 12.5.2023, p. 41.

112 OJ No. L 128, 15.5.2023, p. 52.

113 OJ No. L 128, 15.5.2023, p. 60.

114 OJ No. L 128, 15.5.2023, p. 68.

115 OJ No. L 128, 15.5.2023, p. 73.

116 OJ No. L 129, 16.5.2023, p. 3.

117 OJ No. L 132, 17.5.2023, p. 46.

118 OJ No. L 194, 2.8.2023, p. 4.

119 OJ No. L 194, 2.8.2023, p. 8.

120 OJ No. L 194, 2.8.2023, p. 13.

121 OJ No. L 2210, 23.10.2023, p. 1.

122 OJ No. L 2214, 24.10.2023, p. 1.

123 OJ No. L 2215, 24.10.2023, p. 1.

124 OJ No. L 2847, 21.12.2023, p. 1.

125 OJ No. L 2851, 21.12.2023, p. 1.

126 OJ No. L 2852, 21.12.2023, p. 1.

127 OJ No. L 1023, 9.4.2024, p. 1.

128 OJ No. L 1026, 9.4.2024, p. 1.

129 OJ No. L 1027, 9.4.2024, p. 1.

130 OJ No. L 1037, 10.4.2024, p. 1.

131 OJ No. L 1046, 10.4.2024, p. 1.

132 OJ No. L 1047, 10.4.2024, p. 1.

133 OJ No. L 1048, 10.4.2024, p. 1.

134 OJ No. L 1052, 11.4.2024, p. 1.

135 OJ No. L 1611, 7.6.2024, p. 1.

136 OJ No. L 2036, 30.7.2024, p. 1.

137 OJ No. L 2044, 30.7.2024, p. 1.

138 OJ No. L 2046, 30.7.2024, p. 1.

139 OJ No. L 2047, 30.7.2024, p. 1.

140 OJ No. L 2048, 30.7.2024, p. 1.

141 OJ No. L 2049, 31.7.2024, p. 1.

142 OJ No. L 2061, 31.7.2024, p. 1.

143 OJ No. L 2062, 31.7.2024, p. 1.

144 OJ No. L 2090, 30.7.2024, p. 1.

145 OJ No. L 2101, 31.7.2024, p. 1.

146 OJ No. L 2102, 31.7.2024, p. 1.

147 OJ No. L 2682, 17.10.2024, p. 1.

148 OJ No. L 2694, 18.10.2024, p. 1 as affected by Corrigendum of 18 November 2024 (OJ L, 2024/90741, 24.11.2024).