S.I. No. 253/2022 - European Union (Novel Foods) Regulations 2022 (2022_si_253) | IE

ISB SI

Reg. 1 S.I. No. 253/2022 - European Union (Novel Foods) Regulations 2022 Open official source

1. Regulation (EC) No. 1642/2003 of the European Parliament and of the Council of 22 July 2003

91

ISB SI

Reg. 2 S.I. No. 253/2022 - European Union (Novel Foods) Regulations 2022 Open official source

2. Commission Regulation (EC) No. 575/2006 of 7 April 2006

92

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Reg. 3 S.I. No. 253/2022 - European Union (Novel Foods) Regulations 2022 Open official source

3. Commission Regulation (EC) No. 202/2008 of 4 March 2008

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Reg. 4 S.I. No. 253/2022 - European Union (Novel Foods) Regulations 2022 Open official source

4. Regulation (EU) No. 652/2014 of the European Parliament and of the Council of 15 May 2014

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ISB SI

Reg. 5 S.I. No. 253/2022 - European Union (Novel Foods) Regulations 2022 Open official source

5. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017

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Reg. 6 S.I. No. 253/2022 - European Union (Novel Foods) Regulations 2022 Open official source

6. Regulation (EU) 2019/1243 of the European Parliament and of the Council of 20 June 2019

96

Schedule 2

Form of official certificate to be given by an approved examiner to an authorised officer.

European Union (Novel Foods) Regulations 2022

Certificate of Analysis

To

(1)

........................................

I, the undersigned

(2)

.........................................

being an approved examiner for the purpose of the above Regulations certify that on

the .........................day of .......................... 20......

a sample marked

(3)

....................................

Date .....................................

Number .....................................

Weight or Measure

(4)

..................................

was submitted to me by you and I certify that the sample/relevant thing/copy/photograph of relevant thing was prepared and analysed/examined by me or under my direction

(5)

and as a result I am of the opinion that

(6)

Observations

(7)

I further certify that the sample has undergone no change which would affect my opinion/observations expressed above.

Certified by me this ..................... day of ............................... 20.....

At

(8)

.....................................

Name in BLOCK LETTERS ...............................................................

Status ...........................................................

Signature .........................................................

_______________________

Official Stamp

NOTES

(1) Insert the name and address of the person submitting the sample for analysis.

(2) Insert description (e.g. Executive Analytical Chemist located at a Public Analyst’s Laboratory).

(3) Insert particulars of marking (e.g. name, date, etc.).

(4) This may be left unanswered if the sample cannot be conveniently weighed or measured or the weight or measurement is not material to the result of analysis.

(5) Indicate whether the approved examiner carried out the analysis himself or herself or whether it was carried out by another under the direction of the approved examiner.

(6) Here the approved examiner should specify the result of the analysis having regard to the provisions of the relevant legislation. He or she may also add, if required, a statement, or statements of conformity as per ISO/IEC 17025:2017 on the “General Requirements for the Competence of Testing and Calibration Laboratories”.

(7) Here the approved examiner may insert, at his or her discretion, his or her opinion whether the analysis indicates any addition, abstraction, deficiency or the presence of foreign matter or other defect and whether the composition or quality is thereby affected; any physical, chemical or other properties bearing on the composition or quality of the article; whether the article is injurious to health or unfit for human consumption; whether and in what respect a label and description relating to the sample is incorrect or misleading; and he or she may add any other observations as he or she may consider relevant. In the case of analysis or examination of a relevant thing, or a copy or photograph thereof, the approved examiner may insert, at his or her discretion, any observations in relation to the relevant thing that he or she may consider relevant.

(8) Insert the name and address of the laboratory carrying out the analysis/examination.

GIVEN under my Official Seal,

24 May, 2022.

STEPHEN DONNELLY,

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 full effect to Regulation (EU) No. 2015/2283 of the European Parliament and of the Council of 25 November 2015, on novel foods. They also give full effect to Commission Implementing Regulation (EU) 2017/2468 of 20 December 2017, Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017 and Commission Implementing Regulation (EU) 2018/456 of 19 March 2018 setting out administrative, scientific and consultative requirements to be followed. They also give full effect to Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 which establishes the Union List of Novel Foods.

These Regulations introduce offences and penalties for persons that fail to comply with specific provisions of the foregoing Regulations as provided for in these Regulations.

These Regulations may be cited as the European Union (Novel Foods) Regulations 2022.

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2 OJ No. L 231, 6.9.2019, p. 1.

3 OJ No. L 351, 30.12.2017, p. 55.

4 OJ No. L 406, 3.12.2020, p. 51.

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

6 OJ No. L 77, 20.3.2018, p. 6.

1 OJ No. L 327, 11.12.2015, p. 1.

2 OJ No. L 231, 6.9.2019, p. 1.

3 OJ No. L 351, 30.12.2017, p. 55.

4 OJ No. L 406, 3.12.2020, p. 51.

6 OJ No. L 77, 20.3.2018, p. 6.

7 OJ No. L 31, 1.2.2002, p. 1.

2 OJ No. L 231, 6.9.2019, p. 1.

8 OJ No. L 95, 7.4.2017, p. 1.

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

9 OJ No. L 268, 18.10.2003, p. 1.

10 OJ No. L 354, 31.12.2008, p. 7.

11 OJ No. L 354, 31.12.2008, p. 16.

12 OJ No. L 354, 31.12.2008, p. 34.

13 OJ No. L 141, 6.6.2009, p. 3.

1 OJ No. L 327, 11.12.2015, p. 1.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

91 OJ No. L 245, 29.9.2003, p. 4.

92 OJ No. L 100, 8.4.2006, p. 3.

93 OJ No. L 60, 5.3.2008, p. 17.

94 OJ No. L 189, 27.6.2014, p. 1.

95 OJ No. L 117, 5.5.2017, p. 1.

96 OJ No. L 198, 25.7.2019, p. 241.

ISB SI

Reg. 7 S.I. No. 253/2022 - European Union (Novel Foods) Regulations 2022 Open official source

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

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Reg. 8 S.I. No. 253/2022 - European Union (Novel Foods) Regulations 2022 Open official source

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

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

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

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

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

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Reg. 13 S.I. No. 253/2022 - European Union (Novel Foods) Regulations 2022 Open official source

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

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Reg. 14 S.I. No. 253/2022 - European Union (Novel Foods) Regulations 2022 Open official source

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

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Reg. 15 S.I. No. 253/2022 - European Union (Novel Foods) Regulations 2022 Open official source

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

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

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

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

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Reg. 19 S.I. No. 253/2022 - European Union (Novel Foods) Regulations 2022 Open official source

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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46. Commission Implementing Regulation (EU) 2020/917 of 1 July 2021

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

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

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

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Reg. 50 S.I. No. 253/2022 - European Union (Novel Foods) Regulations 2022 Open official source

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Reg. 71 S.I. No. 253/2022 - European Union (Novel Foods) Regulations 2022 Open official source

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

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

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

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

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

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

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

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Part B

ISB SI

Preamble S.I. No. 253/2022 - European Union (Novel Foods) Regulations 2022 Open official source

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of

27

th May,

2022.

I, STEPHEN DONNELLY, 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 full effect to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015

1

as amended by Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019

2

and associated Implementing Regulations of Commission Implementing Regulation (EU) 2017/2468 of 20 December 2017

3

as amended by Commission Implementing Regulation (EU) 2020/1824 of 2 December 2020

4

, Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017

5

, and Commission Implementing Regulation (EU) 2018/456 of 19 March 2018

6

, and all other associated European acts specified in Schedule 1 to these Regulations, hereby make the following Regulations

PART I

PRELIMINARY

Citation

S.I. No. 253/2022 - European Union (Novel Foods) Regulations 2022

Table of Provisions (78)

Statutory Text (78 Articles)

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