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  4. S.I. No. 40/2025 - European Union (Novel Foods) (Amendment) Regulations 2025

S.I. No. 40/2025 - European Union (Novel Foods) (Amendment) Regulations 2025

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 25th February, 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) Regulations 2025.

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

3. Regulation 13 (as amended by Regulation 5 of the Regulations of 2024) of the Principal Regulations is amended by substituting for paragraph (3) the following:

“(3) Where an authorised officer purchases or takes a sample of food contained in unopened containers and its division into parts—

(a) is not reasonably practicable, or

(b) might affect the composition, integrity or impede the proper analysis of the sample,

the provisions of paragraphs (1) and (2) as regards the division of samples into parts shall be deemed to be complied with if the authorised officer divides the containers into three lots and deals with each lot as if it were a sample as specified under paragraph (1) and (2).”.

4. Regulation 23 (as amended by Regulation 7 of the Regulations of 2024) of the Principal Regulations is amended by inserting after paragraph (5) the following paragraph:

“(6) Food supplements containing 8.0 mg or less of astaxanthin intended for the general population older than 14 years of age, complying with the requirements of Commission Implementing Regulation (EU) 2021/1377 of 19 August 20212 may continue to be placed on the market until 1 February 2024 and may be marketed until their date of minimum durability or use by date.”.

5. Part A of Schedule 1 (as amended by Regulation 8 of the Regulations of 2024) of the Principal Regulations is substituted by the following:

“Schedule 1

Part A

1. Commission Implementing Regulation (EU) 2018/460 of 20 March 20183

2. Commission Implementing Regulation (EU) 2018/461 of 20 March 20184

3. Commission Implementing Regulation (EU) 2018/462 of 20 March 20185

4. Commission Implementing Regulation (EU) 2018/469 of 21 March 20186

5. Commission Implementing Regulation (EU) 2018/991 of 12 July 20187

6. Commission Implementing Regulation (EU) 2018/1011 of 17 July 20188

7. Commission Implementing Regulation (EU) 2018/1018 of 18 July 20189

8. Commission Implementing Regulation (EU) 2018/1023 of 23 July 201810

9. Commission Implementing Regulation (EU) 2018/1032 of 20 July 201811

10. Commission Implementing Regulation (EU) 2018/1122 of 10 August 201812

11. Commission Implementing Regulation (EU) 2018/1123 of 10 August 201813

12. Commission Implementing Regulation (EU) 2018/1132 of 13 August 201814

13. Commission Implementing Regulation (EU) 2018/1133 of 13 August 201815

14. Commission Implementing Regulation (EU) 2018/1293 of 26 September 201816

15. Commission Implementing Regulation (EU) 2018/1631 of 30 October 201817

16. Commission Implementing Regulation (EU) 2018/1632 of 30 October 201818

17. Commission Implementing Regulation (EU) 2018/1633 of 30 October 201819

18. Commission Implementing Regulation (EU) 2018/1647 of 31 October 201820

19. Commission Implementing Regulation (EU) 2018/1648 of 29 October 201821

20. Commission Implementing Regulation (EU) 2018/1991 of 13 December 201822

21. Commission Implementing Regulation (EU) 2018/2016 of 18 December 201823

22. Commission Implementing Regulation (EU) 2018/2017 of 18 December 201824

23. Commission Implementing Regulation (EU) 2019/108 of 24 January 201925

24. Commission Implementing Regulation (EU) 2019/109 of 24 January 201926

25. Commission Implementing Regulation (EU) 2019/110 of 24 January 201927

26. Commission Implementing Regulation (EU) 2019/387 of 11 March 201928

27. Commission Implementing Regulation (EU) 2019/388 of 11 March 201929

28. Commission Implementing Regulation (EU) 2019/456 of 20 March 201930

29. Commission Implementing Regulation (EU) 2019/506 of 26 March 201931

30. Commission Implementing Regulation (EU) 2019/760 of 13 May 201932

31. Commission Implementing Regulation (EU) 2019/1272 of 29 July 201933

32. Commission Implementing Regulation (EU) 2019/1294 of 1 August 201934

33. Commission Implementing Regulation (EU) 2019/1314 of 2 August 201935

34. Commission Implementing Regulation (EU) 2019/1686 of 8 October 201936

35. Commission Implementing Regulation (EU) 2019/1976 of 25 November 201937

36. Commission Implementing Regulation (EU) 2019/1979 of 26 November 201938

37. Commission Implementing Regulation (EU) 2019/2165 of 17 December 201939

38. Commission Implementing Regulation (EU) 2020/16 of 10 January 202040

39. Commission Implementing Regulation (EU) 2020/24 of 13 January 202041

40. Commission Implementing Regulation (EU) 2020/206 of 14 February 202042

41. Commission Implementing Regulation (EU) 2020/443 of 25 March 202043

42. Commission Implementing Regulation (EU) 2020/478 of 1 April 202044

43. Commission Implementing Regulation (EU) 2020/484 of 2 April 202045

44. Commission Implementing Regulation (EU) 2020/500 of 6 April 202046

45. Commission Implementing Regulation (EU) 2020/916 of 1 July 202047

46. Commission Implementing Regulation (EU) 2020/917 of 1 July 202048

47. Commission Implementing Regulation (EU) 2020/973 of 6 July 202049

48. Commission Implementing Regulation (EU) 2020/1163 of 6 August 202050

49. Commission Implementing Regulation (EU) 2020/1559 of 26 October 202051

50. Commission Implementing Regulation (EU) 2020/1634 of 4 November 202052

51. Commission Implementing Regulation (EU) 2020/1820 of 2 December 202053

52. Commission Implementing Regulation (EU) 2020/1821 of 2 December 202054

53. Commission Implementing Regulation (EU) 2020/1822 of 2 December 202055

54. Commission Implementing Regulation (EU) 2020/1993 of 4 December 202056

55. Commission Implementing Regulation (EU) 2021/50 of 22 January 202157

56. Commission Implementing Regulation (EU) 2021/51 of 22 January 202158

57. Commission Implementing Regulation (EU) 2021/82 of 27 January 202159

58. Commission Implementing Regulation (EU) 2021/96 of 28 January 202160

59. Commission Implementing Regulation (EU) 2021/120 of 2 February 202161

60. Commission Implementing Regulation (EU) 2021/668 of 23 April 202162

61. Commission Implementing Regulation (EU) 2021/670 of 23 April 202163

62. Commission Implementing Regulation (EU) 2021/882 of 1 June 202164

63. Commission Implementing Regulation (EU) 2021/900 of 3 June 202165

64. Commission Implementing Regulation (EU) 2021/912 of 4 June 202166

65. Commission Implementing Regulation (EU) 2021/1318 of 9 August 202167

66. Commission Implementing Regulation (EU) 2021/1319 of 9 August 202168

67. Commission Implementing Regulation (EU) 2021/1326 of 10 August 202169

68. Commission Implementing Regulation (EU) 2021/1377 of 19 August 20212

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 ”.

/images/ls

GIVEN under my Official Seal,

20 February, 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) 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 297, 20.8.2021, p. 20.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.