Herbs and Dietary Supplements in the European Union: A Review of the Regulations with Special Focus on Germany and Poland

ABSTRACT

In the European Union, the manufacturing of and the trade in herbs and dietary supplements are regulated by pharmaceutical and food laws. While dietary supplements are subject to food laws, provisions dealing with herbs are primarily to be found in pharmaceutical regulations. Having a basic understanding of the complexities of this regulatory environment can help clinicians and their patients understand the unique challenges and opportunities presented by EU herbs and supplements and may help inform regulatory practices in other countries struggling to ensure quality and safety of such products.

KEYWORDS. :

• herbs
• dietary supplements
• European Union
• regulations

Notes

1 EP and Council Regulation No. 178/2002, O.J. L 31/1 (2002).

2 Id. art. 1, O.J. L 31/1, at 6 (2002).

3 Id. art. 2, O.J. L 31/1, at 7 (2002).

4 Id. art. 2, O.J. L 31/1, at 7 (2002).

5 Id. art. 22, O.J. L 31/1, at 12 (2002).

6 Id. art. 22, O.J. L 31/1, at 12 (2002).

7 Id. art. 22, O.J. L 31/1, at 12 (2002).

8 Id. art. 23, O.J. L 31/1, at 13 (2002).

9 Id. art. 23, O.J. L 31/1, at 13 (2002).

10 Id. art. 24, O.J. L 31/1, at 13 (2002).

11 Id. art. 50, O.J. L 31/1, at 21 (2002).

12 Id. art. 50, O.J. L 31/1, at 21 (2002).

13 Id. art. 53, O.J. L 31/1, at 22 (2002).

14 EP and Council Regulation No. 1924/2006, O.J. L 404/9 (2006).

15 Id. art. 1 O.J. L 404/9, at 5 (2006).

16 Id. art. 1 O.J. L 404/9, at 5 (2006).

17 Id. art. 2 O.J. L 404/9, at 5 (2006).

18 EP and Council Directive No. 2002/46, O.J. L 183/51 (2002).

19 EP and Council Regulation No. 1924/2006, art. 2, O.J. L 404/9, at 5 (2006).

20 EP and Council Directive No. 2002/46, art. 2, O.J. L 183/51 at 2 (2002).

21 Id. art. 2 O.J. L 183/51, at 2 (2002).

22 EP and Council Regulation No. 1924/2006, art. 2, O.J. L 404/9, at 5 (2006).

23 Id. art. 2 O.J. L 404/9, at 5 (2006).

24 Id. art. 3 O.J. L 404/9, at 6 (2006).

25 Id. art. 3 O.J. L 404/9, at 6 (2006).

26 Id. art. 5 O.J. L 404/9, at 7 (2006).

27 Id. art. 5 O.J. L 404/9, at 7 (2006).

28 Id. art. 9 O.J. L 404/9, at 8 (2006).

29 Id. art. 9 O.J. L 404/9, at 8 (2006).

30 Annex to the EP and Council Regulation No. 1924/2006, O.J. L 404/9 (2006).

31 EP and Council Regulation No. 1924/2006, art. 10, O.J. L 404/9, at 8 (2006).

32 Id. art. 12 O.J. L 404/9, at 9 (2006).

33 Id. art. 13 O.J. L 404/9, at 9 (2006).

34 Id. art. 14 O.J. L 404/9, at 9 (2006).

35 Id. art. 15 to 18 O.J. L 404/9, at 10 to 11 (2006).

36 EP and Council Regulation No. 1925/2006, O.J. L 404/26 (2006).

37 Id. art. 1 O.J. L 404/26, at 4 (2006).

38 Id. art. 1 O.J. L 404/26, at 4 (2006).

39 Id. art. 2 O.J. L 404/26, at 4 (2006).

40 Annex I to the EP and Council Regulation No. 1925/2006, O.J. L 404/26 (2006).

41 Annex II to the EP and Council Regulation No. 1925/2006, O.J. L 404/26 (2006).

42 EP and Council Regulation No. 1925/2006, art. 3, O.J. L 404/26, at 4 (2006).

43 Id. art. 4 O.J. L 404/26, at 5 (2006).

44 Id. art. 6 O.J. L 404/26, at 5 (2006).

45 Id. art. 7 O.J. L 404/26, at 6 (2006).

46 Id. art. 8 O.J. L 404/26, at 6 (2006).

47 EP and Council Directive No. 2002/46, O.J. L 183/51 (2002).

48 Id. art. 1 O.J. L 183/51, at 2 (2002).

49 EP and Council Directive No. 2001/83, O.J. L 311/67 (2001).

50 EP and Council Directive No. 2002/46, art. 1, O.J. L 183/51, at 2 (2002).

51 Id. art. 1 O.J. L 183/51, at 2 (2002).

52 EP and Council Regulation No. 1925/2006, O.J. L 404/26 (2006).

53 EP and Council Directive No. 2001/83, O.J. L 311/67 (2001).

54 EP and Council Regulation No. 726/2004, O.J. L 136/1 (2004).

55 EP and Council Directive No. 2001/83, art. 1 no. 2, O.J. L 311/67, at 5 (2001).

56 Id. art. 1 no. 3 O.J. L 311/67, at 5 (2001).

57 Id. art. 1 no. 3 O.J. L 311/67, at 5 (2001).

58 Id. art. 2 O.J. L 311/67, at 7 (2001).

59 Id. art. 6 et seqq. O.J. L 311/67, at 8 (2001).

60 Id. art. 6 O.J. L 311/67, at 8 (2001).

61 Id. art. 13 et seqq. O.J. L 311/67, at 10 (2001).

62 Id. art. 17 O.J. L 311/67, at 11 (2001).

63 Id. art. 24 O.J. L 311/67, at 13 (2001).

64 Id. art. 27 O.J. L 311/67, at 13 (2001).

65 http://www.hma.eu/87.html

66 EP and Council Regulation No. 726/2004, O.J. L 136/1 (2004).

67 EP and Council Directive No. 2001/83, O.J. L 311/67 (2001).

68 EP and Council Regulation No. 726/2004, art. 2, O.J. L 136/1, at 5 (2004).

69 Id. art. 3 O.J. L 126/1, at 5 (2001).

70 Annex to the EP and Council Regulation No. 726/2004, O.J. L 136/1 (2004).

71 Article 70 of the German Constitution.

72 Articles 71 and 73 of the German Constitution.

73 Articles 72 and 74 of the German Constitution.

74 EP and Council Regulation No. 178/2002, O.J. L 31/1 (2002).

75 EP and Council Regulation No. 1924/2006, O.J. L 404/9 (2006).

76 EP and Council Regulation No. 1925/2006, O.J. L 404/26 (2006).

77 Article 74 Par. 1 No 17, 20 of the German Constitution.

78 BGBl. I of 2009, 2205.

79 BGBl. I of 1997, 2296.

80 EP and Council Regulation No. 178/2002, O.J. L 31/1 (2002).

81 EP and Council Regulation No. 178/2002, art. 2 O.J. L 31/1, at 7 (2002).

82 BGBl. I of 2004, 1011.

83 Sec. 1 Par. 1 NemV.

84 Sec. 1 Par. 2 NemV.

85 Sec. 2 NemV.

86 Sec. 3 Par. 1 and 2 NemV.

87 EP and Council Regulation No. 1925/2006, O.J. L 404/26 (2006).

88 Sec. 3 Par. 3 NemV, Sec. 6 Par. 1 NemV.

89 BGBl. I of 1998, 230, 269.

90 Sec. 3 Par. 4 NemV.

91 BGBl. I of 1981, 1625, 1626.

92 Sec. 4 Par. 1 NemV.

93 Sec. 4 Par. 2 NemV.

94 Sec. 6 Par. 2 NemV.

95 Sec. 5 Par. 1 NemV.

96 EP and Council Regulation No. 726/2004, O.J. L 136/1 (2004).

97 EP and Council Directive No. 2001/83, O.J. L 311/67 (2001).

98 BGBl. I of 2005, 3394.

99 Sec. 2 Par. 1 AMG.

100 Sec. 2 Par. 3 AMG.

101 Sec. 3 AMG.

102 Sec. 5 Par. 1 AMG.

103 Sec. 21 Par. 1 AMG.

104 BGBl. I of 2006, 2523.

105 BGBl. I of 1982, 1601.

106 BGBl. I of 1981, 681, 1187.

107 BGBl. I of 2005, 3394.

108 Dz.U. z 2006, nr 171, poz. 1225.

109 Regulation (EC) No 178/2002.

110 Art. 1 Sec. 1 of the UBŻŻ.

111 EP and Council Regulation No. 178/2002, O.J. L 31/1 (2002).

112 Art. 3 No. 39 of the UBŻŻ.

113 Art. 27 Sec. 3 of the UBŻŻ.

114 Art. 27 Sec. 1 of the UBŻŻ.

115 Art. 27 Sec. 4 of the UBŻŻ.

116 Art. 27 Sec. 5 of the UBŻŻ.

117 Art. 29 Sec. 1 of the UBŻŻ.

118 Art. 96 Sec. 2 of the UBŻŻ.

119 Art. 27 Sec. 6 of the UBŻŻ.

120 EP and Council Regulation No. 1925/2006, O.J. L 404/26 (2006).

121 Dz.U. z 2007r, nr 196, poz. 1425.

122 Dz.U. z 2010r, nr 171, poz. 1225.

123 EP and Council Regulation No. 726/2004, O.J. L 136/1 (2004).

124 EP and Council Directive No. 2001/83, O.J. L 311/67 (2001).

125 Dz.U. z 2001r, nr 126, poz. 1381.

126 Art. 2 No. 32 of the PF.

127 Art. 2 Nos. 33a and 38 of the PF.