S.I. No. 240/2019 - European Union (Food Additives) (Amendment) Regulations 2019

1. (1) These Regulations may be cited as the European Union (Food Additives) (Amendment) Regulations 2019.

(2) The Principal Regulations, the Regulations of 2016, the Regulations of 2018 and these Regulations may be cited together as the European Union (Food Additives) Regulations 2015 to 2019.

2. In these Regulations—

“Principal Regulations” means the European Union (Food Additives) Regulations 2015 (

S.I. No. 330 of 2015

);

“Regulations of 2016” means the European Union (Food Additives) (Amendment) Regulations 2016 (

S.I. No. 484 of 2016

);

“Regulations of 2018” means the European Union (Food Additives) (Amendment) Regulations 2018 (

S.I. No. 413 of 2018

).

3. Regulation 2(1) (as amended by Regulation 3 of the Regulations of 2018) of the Principal Regulations is amended—

(

a

) by substituting for the definition of “Annex to Commission Regulation 231/2012” the following

“‘Annex to Commission Regulation 231/2012’ means the Annex to Commission Regulation (EU) No. 231/2012 of 9 March 2012

17

laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No. 1333/2008 of the European Parliament and of the Council, as amended by Commission Regulation (EU) No. 1050/2012 of 8 November 2012

18

, Commission Regulation (EU) No. 25/2013 of 16 January 2013

19

, Commission Regulation (EU) No. 497/2013 of 29 May 2013

20

, Commission Regulation (EU) No. 724/2013 of 26 July 2013

21

, Commission Regulation (EU) No. 739/2013 of 30 July 2013

22

, Commission Regulation (EU) No. 816/2013 of 28 August 2013

23

, Commission Regulation (EU) No. 817/2013 of 28 August 2013

24

, Commission Regulation (EU) No. 1274/2013 of 6 December 2013

25

, Commission Regulation (EU) No. 264/2014 of 14 March 2014

26

, Commission Regulation (EU) No. 298/2014 of 21 March 2014

27

, Commission Regulation (EU) No. 497/2014 of 14 May 2014

28

, Commission Regulation (EU) No. 506/2014 of 15 May 2014

29

, Commission Regulation (EU) No. 685/2014 of 20 June 2014

30

, Commission Regulation (EU) No. 923/2014 of 25 August 2014

31

, Commission Regulation (EU) No. 957/2014 of 10 September 2014

32

, Commission Regulation (EU) No. 966/2014 of 12 September 2014

33

, Commission Regulation (EU) 2015/463 of 19 March 2015

34

, Commission Regulation (EU) 2015/649 of 24 April 2015

35

, Commission Regulation (EU) 2015/1725 of 28 September 2015

36

, Commission Regulation (EU) 2015/1739 of 28 September 2015

37

, Commission Regulation (EU) 2016/1814 of 13 October 2016

38

, Commission Regulation (EU) 2017/324 of 24 February 2017

39

, Commission Regulation (EU) 2017/1399 of 28 July 2017

4

, Commission Regulation (EU) 2018/75 of 17 January 2018

6

, Commission Regulation (EU) 2018/98 of 22 January 2018

8

, Commission Regulation (EU) 2018/681 of 4 May 2018

10

, Commission Regulation (EU) 2018/1461 of 28 September 2018

12

, Commission Regulation (EU) 2018/1462 of 28 September 2018

13

and Commission Regulation (EU) 2018/1481 of 4 October 2018

14

;”,

(

b

) by substituting for the definition of “Annex II to EC Regulation 1333/2008” the following

“‘Annex II to EC Regulation 1333/2008’ means Annex II to Regulation (EC) No. 1333/2008 of the European Parliament and of the Council of 16 December 2008

40

on food additives, as amended by Commission Regulation (EU) No. 1129/2011 of 11 November 2011

41

, Commission Regulation (EU) No. 1131/2011 of 11 November 2011

42

, Commission Regulation (EU) No. 232/2012 of 16 March 2012

43

, Commission Regulation (EU) No. 380/2012 of 3 May 2012

44

, Commission Regulation (EU) No. 470/2012 of 4 June 2012

45

, Commission Regulation (EU) No. 471/2012 of 4 June 2012

46

, Commission Regulation (EU) No. 472/2012 of 4 June 2012

47

, Commission Regulation (EU) No. 570/2012 of 28 June 2012

48

, Commission Regulation (EU) No. 583/2012 of 2 July 2012

49

, Commission Regulation (EU) No. 675/2012 of 23 July 2012

50

, Commission Regulation (EU) No. 1049/2012 of 8 November 2012

51

, Commission Regulation (EU) No. 1057/2012 of 12 November 2012

52

, Commission Regulation (EU) No. 1147/2012 of 4 December 2012

53

, Commission Regulation (EU) No. 1148/2012 of 4 December 2012

54

, Commission Regulation (EU) No. 1149/2012 of 4 December 2012

55

, Commission Regulation (EU) No. 1166/2012 of 7 December 2012

56

, Commission Regulation (EU) No. 25/2013 of 16 January 2013

19

, Commission Regulation (EU) No. 438/2013 of 13 May 2013

57

, Commission Regulation (EU) No. 509/2013 of 3 June 2013

58

, Commission Regulation (EU) No. 510/2013 of 3 June 2013

59

, Commission Regulation (EU) No. 723/2013 of 26 July 2013

60

, Commission Regulation (EU) No. 738/2013 of 30 July 2013

61

, Commission Regulation (EU) No. 739/2013 of 30 July 2013

22

, Commission Regulation (EU) No. 816/2013 of 28 August 2013

23

, Commission Regulation (EU) No. 817/2013 of 28 August 2013

24

, Commission Regulation (EU) No. 913/2013 of 23 September 2013

62

, Commission Regulation (EU) No. 1068/2013 of 30 October 2013

63

, Commission Regulation (EU) No. 1069/2013 of 30 October 2013

64

, Commission Regulation (EU) No. 1274/2013 of 6 December 2013

25

, Commission Regulation (EU) No. 59/2014 of 23 January 2014

65

, Commission Regulation (EU) No. 264/2014 of 14 March 2014

26

, Commission Regulation (EU) No. 298/2014 of 21 March 2014

27

, Commission Regulation (EU) No. 497/2014 of 14 May 2014

28

, Commission Regulation (EU) No. 505/2014 of 15 May 2014

66

, Commission Regulation (EU) No. 506/2014 of 15 May 2014

29

, Commission Regulation (EU) No. 601/2014 of 4 June 2014

67

, Commission Regulation (EU) No. 685/2014 of 20 June 2014

30

, Commission Regulation (EU) No. 923/2014 of 25 August 2014

31

, Commission Regulation (EU) No. 957/2014 of 10 September 2014

32

, Commission Regulation (EU) No. 969/2014 of 12 September 2014

68

, Commission Regulation (EU) No. 1084/2014 of 15 October 2014

69

, Commission Regulation (EU) No. 1092/2014 of 16 October 2014

70

, Commission Regulation (EU) No. 1093/2014 of 16 October 2014

71

, Commission Regulation (EU) 2015/537 of 31 March 2015

72

, Commission Regulation (EU) 2015/538 of 31 March 2015

73

, Commission Regulation (EU) 2015/647 of 24 April 2015

74

, Commission Regulation (EU) 2015/649 of 24 April 2015

35

, Commission Regulation (EU) 2015/1378 of 11 August 2015

75

, Commission Regulation (EU) 2015/1739 of 28 September 2015

37

, Commission Regulation (EU) 2015/1832 of 12 October 2015

76

, Commission Regulation (EU) 2016/56 of 19 January 2016

77

, Commission Regulation (EU) 2016/263 of 25 February 2016

78

, Commission Regulation (EU) 2016/324 of 7 March 2016

79

, Commission Regulation (EU) 2016/441 of 23 March 2016

80

, Commission Regulation (EU) 2016/479 of 1 April 2016

81

, Commission Regulation (EU) 2016/683 of 2 May 2016

82

, Commission Regulation (EU) 2016/691 of 4 May 2016

83

, Commission Regulation (EU) 2016/1776 of 6 October 2016

84

, Commission Regulation (EU) 2017/335 of 27 February 2017

85

, Commission Regulation (EU) 2017/839 of 17 May 2017

86

, Commission Regulation (EU) 2017/871 of 22 May 2017

87

, Commission Regulation (EU) 2017/1270 of 14 July 2017

2

, Commission Regulation (EU) 2017/1399 of 28 July 2017

4

, Commission Regulation (EU) 2018/74 of 17 January 2018

5

, Commission Regulation (EU) 2018/97 of 22 January 2018

7

, Commission Regulation (EU) 2018/98 of 22 January 2018

8

, Commission Regulation (EU) 2018/677 of 3 May 2018

9

, Commission Regulation (EU) 2018/682 of 4 May 2018

11

, Commission Regulation (EU) 2018/1461 of 28 September 2018

12

, Commission Regulation (EU) 2018/1481 of 4 October 2018

14

, and Commission Regulation (EU) 2018/1497 of 8 October 2018

15

as affected by the Corrigendum to Commission Regulation (EU) 2018/1497

16

;”,

(

c

) by substituting for the definition of “Annex III to EC Regulation 1333/2008” the following

“‘Annex III to EC Regulation 1333/2008’ means Annex III to Regulation (EC) No. 1333/2008 of the European Parliament and of the Council of 16 December 2008

40

on food additives, as amended by Commission Regulation (EU) No. 1130/2011 of 11 November 2011

88

, Commission Regulation (EU) No. 25/2013 of 16 January 2013

19

, Commission Regulation (EU) No. 244/2013 of 19 March 2013

89

, Commission Regulation (EU) No. 256/2013 of 20 March 2013

90

, Commission Regulation (EU) No. 510/2013 of 3 June 2013

59

, Commission Regulation (EU) No. 817/2013 of 28 August 2013

24

, Commission Regulation (EU) No. 818/2013 of 28 August 2013

91

, Commission Regulation (EU) No. 1274/2013 of 6 December 2013

25

, Commission Regulation (EU) 2015/639 of 23 April 2015

92

, Commission Regulation (EU) 2015/647 of 24 April 2015

74

, Commission Regulation (EU) 2015/1362 of 6 August 2015

93

, Commission Regulation (EU) 2017/874 of 22 May 2017

1

, Commission Regulation (EU) 2017/1271 of 14 July 2017

3

, Commission Regulation (EU) 2018/98 of 22 January 2018

8

and Commission Regulation (EU) 2018/1481 of 4 October 2018

14

;”,

(

d

) by substituting for the definition of “Commission Regulation 231/2012” the following

“‘Commission Regulation 231/2012’ means Commission Regulation (EU) No. 231/2012 of 9 March 2012

17

laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No. 1333/2008 of the European Parliament and of the Council, as amended by Commission Regulation (EU) No. 1050/2012 of 8 November 2012

18

, Commission Regulation (EU) No. 25/2013 of 16 January 2013

19

, Commission Regulation (EU) No. 497/2013 of 29 May 2013

20

, Commission Regulation (EU) No. 724/2013 of 26 July 2013

21

, Commission Regulation (EU) No. 739/2013 of 30 July 2013

22

, Commission Regulation (EU) No. 816/2013 of 28 August 2013

23

, Commission Regulation (EU) No. 817/2013 of 28 August 2013

24

, Commission Regulation (EU) No. 1274/2013 of 6 December 2013

25

, Commission Regulation (EU) No. 264/2014 of 14 March 2014

26

, Commission Regulation (EU) No. 298/2014 of 21 March 2014

27

, Commission Regulation (EU) No. 497/2014 of 14 May 2014

28

, Commission Regulation (EU) No. 506/2014 of 15 May 2014

29

, Commission Regulation (EU) No. 685/2014 of 20 June 2014

30

, Commission Regulation (EU) No. 923/2014 of 25 August 2014

31

, Commission Regulation (EU) No. 957/2014 of 10 September 2014

32

, Commission Regulation (EU) No. 966/2014 of 12 September 2014

33

, Commission Regulation (EU) 2015/463 of 19 March 2015

34

, Commission Regulation (EU) 2015/649 of 24 April 2015

35

, Commission Regulation (EU) 2015/1725 of 28 September 2015

36

, Commission Regulation (EU) 2015/1739 of 28 September 2015

37

, Commission Regulation (EU) 2016/1814 of 13 October 2016

38

, Commission Regulation (EU) 2017/324 of 24 February 2017

39

, Commission Regulation (EU) 2017/1399 of 28 July 2017

4

, Commission Regulation (EU) 2018/75 of 17 January 2018

6

, Commission Regulation (EU) 2018/98 of 22 January 2018

8

, Commission Regulation (EU) 2018/681 of 4 May 2018

10

, Commission Regulation (EU) 2018/1461 of 28 September 2018

12

, Commission Regulation (EU) 2018/1462 of 28 September 2018

13

and Commission Regulation (EU) 2018/1481 of 4 October 2018

14

;”, and

(

e

) by substituting for the definition of “EC Regulation 1333/2008” the following

“‘EC Regulation 1333/2008’ means Regulation (EC) No. 1333/2008 of the European Parliament and of the Council of 16 December 2008

40

on food additives as amended by Commission Regulation (EU) No. 238/2010 of 22 March 2010

94

, Commission Regulation (EU) No. 257/2010 of 25 March 2010

95

, Commission Regulation (EU) No. 1129/2011 of 11 November 2011

41

, Commission Regulation (EU) No. 1130/2011 of 11 November 2011

88

, Commission Regulation (EU) No. 1131/2011 of 11 November 2011

42

, Commission Regulation (EU) No. 232/2012 of 16 March 2012

43

, Commission Regulation (EU) No. 380/2012 of 3 May 2012

44

, Commission Regulation (EU) No. 470/2012 of 4 June 2012

45

, Commission Regulation (EU) No. 471/2012 of 4 June 2012

46

, Commission Regulation (EU) No. 472/2012 of 4 June 2012

47

, Commission Regulation (EU) No. 570/2012 of 28 June 2012

48

, Commission Regulation (EU) No. 583/2012 of 2 July 2012

49

, Commission Regulation (EU) No. 675/2012 of 23 July 2012

50

, Commission Regulation (EU) No. 1049/2012 of 8 November 2012

51

, Commission Regulation (EU) No. 1057/2012 of 12 November 2012

52

, Commission Regulation (EU) No. 1147/2012 of 4 December 2012

53

, Commission Regulation (EU) No. 1148/2012 of 4 December 2012

54

, Commission Regulation (EU) No. 1149/2012 of 4 December 2012

55

, Commission Regulation (EU) No. 1166/2012 of 7 December 2012

56

, Commission Regulation (EU) No. 25/2013 of 16 January 2013

19

, Commission Regulation (EU) No. 244/2013 of 19 March 2013

89

, Commission Regulation (EU) No. 256/2013 of 20 March 2013

90

, Commission Regulation (EU) No. 438/2013 of 13 May 2013

57

, Commission Regulation (EU) No. 509/2013 of 3 June 2013

58

, Commission Regulation (EU) No. 510/2013 of 3 June 2013

59

, Commission Regulation (EU) No. 723/2013 of 26 July 2013

60

, Commission Regulation (EU) No. 738/2013 of 30 July 2013

61

, Commission Regulation (EU) No. 739/2013 of 30 July 2013

22

, Commission Regulation (EU) No. 816/2013 of 28 August 2013

23

, Commission Regulation (EU) No. 817/2013 of 28 August 2013

24

, Commission Regulation (EU) No. 818/2013 of 28 August 2013

91

, Commission Regulation (EU) No. 913/2013 of 23 September 2013

62

, Commission Regulation (EU) No. 1068/2013 of 30 October 2013

63

, Commission Regulation (EU) No. 1069/2013 of 30 October 2013

64

, Commission Regulation (EU) No. 1274/2013 of 6 December 2013

25

, Commission Regulation (EU) No. 59/2014 of 23 January 2014

65

, Commission Regulation (EU) No. 264/2014 of 14 March 2014

26

, Commission Regulation (EU) No. 298/2014 of 21 March 2014

27

, Commission Regulation (EU) No. 497/2014 of 14 May 2014

28

, Commission Regulation (EU) No. 505/2014 of 15 May 2014

66

, Commission Regulation (EU) No. 506/2014 of 15 May 2014

29

, Commission Regulation (EU) No. 601/2014 of 4 June 2014

67

, Commission Regulation (EU) No. 685/2014 of 20 June 2014

30

, Commission Regulation (EU) No. 923/2014 of 25 August 2014

31

, Commission Regulation (EU) No. 957/2014 of 10 September 2014

32

, Commission Regulation (EU) No. 969/2014 of 12 September 2014

68

, Commission Regulation (EU) No. 1084/2014 of 15 October 2014

69

, Commission Regulation (EU) No. 1092/2014 of 16 October 2014

70

, Commission Regulation (EU) No. 1093/2014 of 16 October 2014

71

, Commission Regulation (EU) 2015/537 of 31 March 2015

72

, Commission Regulation (EU) 2015/538 of 31 March 2015

73

, Commission Regulation (EU) 2015/639 of 23 April 2015

92

, Commission Regulation (EU) 2015/647 of 24 April 2015

74

, Commission Regulation (EU) 2015/649 of 24 April 2015

35

, Commission Regulation (EU) 2015/1362 of 6 August 2015

93

, Commission Regulation (EU) 2015/1378 of 11 August 2015

75

, Commission Regulation (EU) 2015/1739 of 28 September 2015

37

, Commission Regulation (EU) 2015/1832 of 12 October 2015

76

, Commission Regulation (EU) 2016/56 of 19 January 2016

77

, Commission Regulation (EU) 2016/263 of 25 February 2016

78

, Commission Regulation (EU) 2016/324 of 7 March 2016

79

, Commission Regulation (EU) 2016/441 of 23 March 2016

80

, Commission Regulation (EU) 2016/479 of 1 April 2016

81

, Commission Regulation (EU) 2016/683 of 2 May 2016

82

, Commission Regulation (EU) 2016/691 of 4 May 2016

83

, Commission Regulation (EU) 2016/1776 of 6 October 2016

84

, Commission Regulation (EU) 2017/335 of 27 February 2017

85

, Commission Regulation (EU) 2017/839 of 17 May 2017

86

, Commission Regulation (EU) 2017/871 of 22 May 2017

87

, Commission Regulation (EU) 2017/874 of 22 May 2017

1

, Commission Regulation (EU) 2017/1270 of 14 July 2017

2

, Commission Regulation (EU) 2017/1271 of 14 July 2017

3

, Commission Regulation (EU) 2017/1399 of 28 July 2017

4

, Commission Regulation (EU) 2018/74 of 17 January 2018

5

, Commission Regulation (EU) 2018/97 of 22 January 2018

7

, Commission Regulation (EU) 2018/98 of 22 January 2018

8

, Commission Regulation (EU) 2018/677 of 3 May 2018

9

, Commission Regulation (EU) 2018/682 of 4 May 2018

11

, Commission Regulation (EU) 2018/1461 of 28 September 2018

12

, Commission Regulation (EU) 2018/1481 of 4 October 2018

14

, and Commission Regulation (EU) 2018/1497 of 8 October 2018

15

as affected by the Corrigendum to Commission Regulation (EU) 2018/1497

16

.;”.

4. Regulation 27 of the Principal Regulations is amended by inserting after paragraph (14) the following

“(15) Notwithstanding the provisions of Part 2, a food business operator is not guilty of an offence under these Regulations for failure to comply with Annex II to EC Regulation 1333/2008 as amended by Commission Regulation (EU) 2018/97 of 22 January 2018

7

, in respect of fine bakery products for special nutritional uses containing E 950 Acesulfame K, E 951 Aspartame, E 952 Cyclamic acid and its Na and Ca salts, E 954 Saccharin and its Na, K and Ca salts, E 955 Sucralose, E 959 Neohesperidine DC, E 961 Neotame, E 962 Salt of aspartame-acesulfame or E 969 Advantame, placed on the market prior to 12 February 2018, which may continue to be marketed after that date until stocks are exhausted, provided that, in all such cases, such foods were placed on the market in conformity with the provisions applicable thereto at the date of their placing on the market.”.

GIVEN under my Official Seal,

28 May 2019

SIMON HARRIS,

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 Regulation (EU) 2017/874 of 22 May 2017, Commission Regulation (EU) 2017/1270 of 14 July 2017, Commission Regulation (EU) 2017/1271 of 14 July 2017, Commission Regulation (EU) 2017/1399 of 28 July 2017, Commission Regulation (EU) 2018/74 of 17 January 2018, Commission Regulation (EU) 2018/75 of 17 January 2018, Commission Regulation (EU) 2018/97 of 22 January 2018, Commission Regulation (EU) 2018/98 of 22 January 2018, Commission Regulation (EU) 2018/677 of 3 May 2018, Commission Regulation (EU) 2018/681 of 4 May 2018, Commission Regulation (EU) 2018/682 of 4 May 2018, Commission Regulation (EU) 2018/1461 of 28 September 2018, Commission Regulation (EU) 2018/1462 of 28 September 2018, Commission Regulation (EU) 2018/1481 of 4 October 2018, Commission Regulation (EU) 2018/1497 of 8 October 2018 as affected by the Corrigendum to Commission Regulation (EU) 2018/1497 of 8 October 2018 which amend Regulation (EC) No. 1333/2008 of the European Parliament and of the Council of 16 December 2008 and Commission Regulation (EU) No. 231/2012 of 9 March 2012.

These Regulations amend the European Union (Food Additives) Regulations 2015 for that purpose.

These Regulations may be cited as the European Union (Food Additives) (Amendment) Regulations 2019.

1 OJ No. L 134, 23.5.2017, p. 18.

2 OJ No. L 184, 15.7.2017, p. 1.

3 OJ No. L 184, 15.7.2017, p. 3.

4 OJ No. L 199, 29.7.2017, p. 8.

5 OJ No. L 13, 18.1.2018, p. 21.

6 OJ No. L 13, 18.1.2018, p. 24.

7 OJ No. L 17, 23.1.2018, p. 11.

8 OJ No. L 17, 23.1.2018, p. 14.

9 OJ No. L 114, 4.5.2018, p. 10.

10 OJ No. L 116, 7.5.2018, p. 1.

11 OJ No. L 116, 7.5.2018, p. 5.

12 OJ No. L 245, 1.10.2018, p. 1.

13 OJ No. L 245, 1.10.2018, p. 6.

14 OJ No. L 251, 5.10.2018, p. 13.

15 OJ No. L 253, 9.10.2018, p. 36.

16 OJ No. L 60, 28.2.2019, p. 35.

17 OJ No. L 83, 22.3.2012, p. 1.

18 OJ No. L 310, 9.11.2012, p. 45.

19 OJ No. L 13, 17.1.2013, p. 1.

20 OJ No. L 143, 30.5.2013, p. 20.

21 OJ No. L 202, 27.7.2013, p. 11.

22 OJ No. L 204, 31.7.2013, p. 35.

23 OJ No. L 230, 29.8.2013, p. 1.

24 OJ No. L 230, 29.8.2013, p. 7.

25 OJ No. L 328, 7.12.2013, p. 79.

26 OJ No. L 76, 15.3.2014, p. 22.

27 OJ No. L 89, 25.3.2014, p. 36.

28 OJ No. L 143, 15.5.2014, p. 6.

29 OJ No. L 145, 16.5.2014, p. 35.

30 OJ No. L 182, 21.6.2014, p. 23.

31 OJ No. L 252, 26.8.2014, p. 11.

32 OJ No. L 270, 11.9.2014, p. 1.

33 OJ No. L 272, 13.9.2014, p. 1.

34 OJ No. L 76, 20.3.2015, p. 42.

35 OJ No. L 107, 25.4.2015, p. 17.

36 OJ No. L 252, 29.9.2015, p. 12.

37 OJ No. L 253, 30.9.2015, p. 3.

38 OJ No. L 278, 14.10.2016, p. 37.

39 OJ No. L 49, 25.2.2017, p. 4.

4 OJ No. L 199, 29.7.2017, p. 8.

6 OJ No. L 13, 18.1.2018, p. 24.

8 OJ No. L 17, 23.1.2018, p. 14.

10 OJ No. L 116, 7.5.2018, p. 1.

12 OJ No. L 245, 1.10.2018, p. 1.

13 OJ No. L 245, 1.10.2018, p. 6.

14 OJ No. L 251, 5.10.2018, p. 13.

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

41 OJ No. L 295, 12.11.2011, p. 1.

42 OJ No. L 295, 12.11.2011, p. 205.

43 OJ No. L 78, 17.3.2012, p. 1.

44 OJ No. L 119, 4.5.2012, p. 14.

45 OJ No. L 144, 5.6.2012, p. 16.

46 OJ No. L 144, 5.6.2012, p. 19.

47 OJ No. L 144, 5.6.2012, p. 22.

48 OJ No. L 169, 29.6.2012, p. 43.

49 OJ No. L 173, 3.7.2012, p. 8.

50 OJ No. L 196, 24.7.2012, p. 52.

51 OJ No. L 310, 9.11.2012, p. 41.

52 OJ No. L 313, 13.11.2012, p. 11

53 OJ No. L 333, 5.12.2012, p. 34.

54 OJ No. L 333, 5.12.2012, p. 37.

55 OJ No. L 333, 5.12.2012, p. 40.

56 OJ No. L 336, 8.12.2012, p. 75.

19 OJ No. L 13, 17.1.2013, p. 1.

57 OJ No. L 129, 14.5.2013, p. 28.

58 OJ No. L 150, 4.6.2013, p. 13.

59 OJ No. L 150, 4.6.2013, p. 17.

60 OJ No. L 202, 27.7.2013, p. 8.

61 OJ No. L 204, 31.7.2013, p. 32.

22 OJ No. L 204, 31.7.2013, p. 35.

23 OJ No. L 230, 29.8.2013, p. 1.

24 OJ No. L 230, 29.8.2013, p. 7.

62 OJ No. L 252, 24.9.2013, p. 11.

63 OJ No. L 289, 31.10.2013, p. 58.

64 OJ No. L 289, 31.10.2013, p. 61.

25 OJ No. L 328, 7.12.2013, p. 79.

65 OJ No. L 21, 24.1.2014, p. 9.

26 OJ No. L 76, 15.3.2014, p. 22.

27 OJ No. L 89, 25.3.2014, p. 36.

28 OJ No. L 143, 15.5.2014, p. 6.

66 OJ No. L 145, 16.5.2014, p. 32.

29 OJ No. L 145, 16.5.2014, p. 35.

67 OJ No. L 166, 5.6.2014, p. 11.

30 OJ No. L 182, 21.6.2014, p. 23.

31 OJ No. L 252, 26.8.2014, p. 11.

32 OJ No. L 270, 11.9.2014, p. 1.

68 OJ No. L 272, 13.9.2014, p. 8.

69 OJ No. L 298, 16.10.2014, p. 8.

70 OJ No. L 299, 17.10.2014, p. 19.

71 OJ No. L 299, 17.10.2014, p. 22.

72 OJ No. L 88, 1.4.2015, p. 1.

73 OJ No. L 88, 1.4.2015, p. 4.

74 OJ No. L 107, 25.4.2015, p. 1.

35 OJ No. L 107, 25.4.2015, p. 17.

75 OJ No. L 213, 12.8.2015, p. 1.

37 OJ No. L 253, 30.9.2015, p. 3.

76 OJ No. L 266, 13.10.2015, p. 27.

77 OJ No. L 13, 20.1.2016, p. 46.

78 OJ No. L 50, 26.2.2016, p. 25.

79 OJ No. L 61, 8.3.2016, p. 1.

80 OJ No. L 78, 24.3.2016, p. 47.

81 OJ No. L 87, 2.4.2016, p. 1.

82 OJ No. L 117, 3.5.2016, p. 28.

83 OJ No. L 120, 5.5.2016, p. 4.

84 OJ No. L 272, 7.10.2016, p. 2.

85 OJ No. L 50, 28.2.2017, p. 15.

86 OJ No. L 125, 18.5.2017, p. 7.

87 OJ No. L 134, 23.5.2017, p. 3.

2 OJ No. L 184, 15.7.2017, p. 1.

4 OJ No. L 199, 29.7.2017, p. 8.

5 OJ No. L 13, 18.1.2018, p. 21.

7 OJ No. L 17, 23.1.2018, p. 11.

8 OJ No. L 17, 23.1.2018, p. 14.

9 OJ No. L 114, 4.5.2018, p. 10.

11 OJ No. L 116, 7.5.2018, p. 5.

12 OJ No. L 245, 1.10.2018, p. 1.

14 OJ No. L 251, 5.10.2018, p. 13.

15 OJ No. L 253, 9.10.2018, p. 36.

16 OJ No. L 60, 28.2.2019, p. 35.

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

88 OJ No. L 295, 12.11.2011, p. 178.

19 OJ No. L 13, 17.1.2013, p. 1.

89 OJ No. L 77, 20.3.2013, p. 3.

90 OJ No. L 79, 21.3.2013, p. 24.

59 OJ No. L 150, 4.6.2013, p. 17.

24 OJ No. L 230, 29.8.2013, p. 7.

91 OJ No. L 230, 29.8.2013, p. 12.

25 OJ No. L 328, 7.12.2013, p. 79.

92 OJ No. L 106, 24.4.2015, p. 16.

74 OJ No. L 107, 25.4.2015, p. 1.

93 OJ No. L 210, 7.8.2015, p. 22.

1 OJ No. L 134, 23.5.2017, p. 18.

3 OJ No. L 184, 15.7.2017, p. 3.

8 OJ No. L 17, 23.1.2018, p. 14.

14 OJ No. L 251, 5.10.2018, p. 13.

17 OJ No. L 83, 22.3.2012, p. 1.

18 OJ No. L 310, 9.11.2012, p. 45.

19 OJ No. L 13, 17.1.2013, p. 1.

20 OJ No. L 143, 30.5.2013, p. 20.

21 OJ No. L 202, 27.7.2013, p. 11.

22 OJ No. L 204, 31.7.2013, p. 35.

23 OJ No. L 230, 29.8.2013, p. 1.

24 OJ No. L 230, 29.8.2013, p. 7.

25 OJ No. L 328, 7.12.2013, p. 79.

26 OJ No. L 76, 15.3.2014, p. 22.

27 OJ No. L 89, 25.3.2014, p. 36.

28 OJ No. L 143, 15.5.2014, p. 6.

29 OJ No. L 145, 16.5.2014, p. 35.

30 OJ No. L 182, 21.6.2014, p. 23.

31 OJ No. L 252, 26.8.2014, p. 11.

32 OJ No. L 270, 11.9.2014, p. 1.

33 OJ No. L 272, 13.9.2014, p. 1.

34 OJ No. L 76, 20.3.2015, p. 42.

35 OJ No. L 107, 25.4.2015, p. 17.

36 OJ No. L 252, 29.9.2015, p. 12.

37 OJ No. L 253, 30.9.2015, p. 3.

38 OJ No. L 278, 14.10.2016, p. 37.

39 OJ No. L 49, 25.2.2017, p. 4.

4 OJ No. L 199, 29.7.2017, p. 8.

6 OJ No. L 13, 18.1.2018, p. 24.

8 OJ No. L 17, 23.1.2018, p. 14.

10 OJ No. L 116, 7.5.2018, p. 1.

12 OJ No. L 245, 1.10.2018, p. 1.

13 OJ No. L 245, 1.10.2018, p. 6.

14 OJ No. L 251, 5.10.2018, p. 13.

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

94 OJ No. L 75, 23.3.2010, p. 17.

95 OJ No. L 80, 26.3.2010, p. 19.

41 OJ No. L 295, 12.11.2011, p. 1.

88 OJ No. L 295, 12.11.2011, p. 178.

42 OJ No. L 295, 12.11.2011, p. 205.

43 OJ No. L 78, 17.3.2012, p. 1.

44 OJ No. L 119, 4.5.2012, p. 14.

45 OJ No. L 144, 5.6.2012, p. 16.

46 OJ No. L 144, 5.6.2012, p. 19.

47 OJ No. L 144, 5.6.2012, p. 22.

48 OJ No. L 169, 29.6.2012, p. 43.

49 OJ No. L 173, 3.7.2012, p. 8.

50 OJ No. L 196, 24.7.2012, p. 52.

51 OJ No. L 310, 9.11.2012, p. 41.

52 OJ No. L 313, 13.11.2012, p. 11

53 OJ No. L 333, 5.12.2012, p. 34.

54 OJ No. L 333, 5.12.2012, p. 37.

55 OJ No. L 333, 5.12.2012, p. 40.

56 OJ No. L 336, 8.12.2012, p. 75.

19 OJ No. L 13, 17.1.2013, p. 1.

89 OJ No. L 77, 20.3.2013, p. 3.

90 OJ No. L 79, 21.3.2013, p. 24.

57 OJ No. L 129, 14.5.2013, p. 28.

58 OJ No. L 150, 4.6.2013, p. 13.

59 OJ No. L 150, 4.6.2013, p. 17.

60 OJ No. L 202, 27.7.2013, p. 8.

61 OJ No. L 204, 31.7.2013, p. 32.

22 OJ No. L 204, 31.7.2013, p. 35.

23 OJ No. L 230, 29.8.2013, p. 1.

24 OJ No. L 230, 29.8.2013, p. 7.

91 OJ No. L 230, 29.8.2013, p. 12.

62 OJ No. L 252, 24.9.2013, p. 11.

63 OJ No. L 289, 31.10.2013, p. 58.

64 OJ No. L 289, 31.10.2013, p. 61.

25 OJ No. L 328, 7.12.2013, p. 79.

65 OJ No. L 21, 24.1.2014, p. 9.

26 OJ No. L 76, 15.3.2014, p. 22.

27 OJ No. L 89, 25.3.2014, p. 36.

28 OJ No. L 143, 15.5.2014, p. 6.

66 OJ No. L 145, 16.5.2014, p. 32.

29 OJ No. L 145, 16.5.2014, p. 35.

67 OJ No. L 166, 5.6.2014, p. 11.

30 OJ No. L 182, 21.6.2014, p. 23.

31 OJ No. L 252, 26.8.2014, p. 11.

32 OJ No. L 270, 11.9.2014, p. 1.

68 OJ No. L 272, 13.9.2014, p. 8.

69 OJ No. L 298, 16.10.2014, p. 8.

70 OJ No. L 299, 17.10.2014, p. 19.

71 OJ No. L 299, 17.10.2014, p. 22.

72 OJ No. L 88, 1.4.2015, p. 1.

73 OJ No. L 88, 1.4.2015, p. 4.

92 OJ No. L 106, 24.4.2015, p. 16.

74 OJ No. L 107, 25.4.2015, p. 1.

35 OJ No. L 107, 25.4.2015, p. 17.

93 OJ No. L 210, 7.8.2015, p. 22.

75 OJ No. L 213, 12.8.2015, p. 1.

37 OJ No. L 253, 30.9.2015, p. 3.

76 OJ No. L 266, 13.10.2015, p. 27.

77 OJ No. L 13, 20.1.2016, p. 46.

78 OJ No. L 50, 26.2.2016, p. 25.

79 OJ No. L 61, 8.3.2016, p. 1.

80 OJ No. L 78, 24.3.2016, p. 47.

81 OJ No. L 87, 2.4.2016, p. 1.

82 OJ No. L 117, 3.5.2016, p. 28.

83 OJ No. L 120, 5.5.2016, p. 4.

84 OJ No. L 272, 7.10.2016, p. 2.

85 OJ No. L 50, 28.2.2017, p. 15.

86 OJ No. L 125, 18.5.2017, p. 7.

87 OJ No. L 134, 23.5.2017, p. 3.

1 OJ No. L 134, 23.5.2017, p. 18.

2 OJ No. L 184, 15.7.2017, p. 1.

3 OJ No. L 184, 15.7.2017, p. 3.

4 OJ No. L 199, 29.7.2017, p. 8.

5 OJ No. L 13, 18.1.2018, p. 21.

7 OJ No. L 17, 23.1.2018, p. 11.

8 OJ No. L 17, 23.1.2018, p. 14.

9 OJ No. L 114, 4.5.2018, p. 10.

11 OJ No. L 116, 7.5.2018, p. 5.

12 OJ No. L 245, 1.10.2018, p. 1.

14 OJ No. L 251, 5.10.2018, p. 13.

15 OJ No. L 253, 9.10.2018, p. 36.

16 OJ No. L 60, 28.2.2019, p. 35.

7 OJ No. L 17, 23.1.2018, p. 11.

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of

7

th June,

2019.

I, SIMON HARRIS, 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 Commission Regulation (EU) 2017/874 of 22 May 2017

1

, Commission Regulation (EU) 2017/1270 of 14 July 2017

2

, Commission Regulation (EU) 2017/1271 of 14 July 2017

3

, Commission Regulation (EU) 2017/1399 of 28 July 2017

4

, Commission Regulation (EU) 2018/74 of 17 January 2018

5

, Commission Regulation (EU) 2018/75 of 17 January 2018

6

, Commission Regulation (EU) 2018/97 of 22 January 2018

7

, Commission Regulation (EU) 2018/98 of 22 January 2018

8

, Commission Regulation (EU) 2018/677 of 3 May 2018

9

, Commission Regulation (EU) 2018/681 of 4 May 2018

10

, Commission Regulation (EU) 2018/682 of 4 May 2018

11

, Commission Regulation (EU) 2018/1461 of 28 September 2018

12

, Commission Regulation (EU) 2018/1462 of 28 September 2018

13

, Commission Regulation (EU) 2018/1481 of 4 October 2018

14

and Commission Regulation (EU) 2018/1497 of 8 October 2018

15

as affected by the Corrigendum to Commission Regulation (EU) 2018/1497

16

, hereby make the following regulations