Decree No. 39 / 2018 Coll.
Decree amending Decree No. 54 / 2004 Coll., on foodstuffs intended for particular nutritional uses and their method of use, as amended
Valid
Effective from 01.04.2018
39
DECLARATION
of 2 March 2018
amending Decree No 54 / 2004 Coll., on foodstuffs intended for particular nutritional uses and their method of use, as amended
According to Article 19 (1) (c) of Act No. 110 / 1997 Coll., on Food and Tobacco Products and amending and supplementing certain related laws, as amended by Act No. 139 / 2014 Coll.:
Decree No. 54 / 2004 Coll., on foods intended for particular nutritional uses and their method of use, as amended by Decree No. 402 / 2006 Coll., Decree No. 473 / 2006 Coll., Decree No. 157 / 2008 Coll., Decree No. 35 / 2012 Coll. and Decree No. 46 / 2014 Coll., are amended as follows:
1. In Article 1 (1), the words "for particular nutritional uses' are deleted.
2. footnotes 1 and 1a read:
"(1) Commission Directive 96 / 8 / EC of 26 February 1996 on foodstuffs for low energy nutrition for weight reduction, as amended. Commission Directive 1999 / 21 / EC of 25 March 1999 on dietary foods for special medical purposes, as amended. Commission Directive 2006 / 125 / EC of 5 December 2006 on cereal-based foods and baby foods for infants and young children. Commission Directive 2006 / 141 / EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999 / 21 / EC, as amended by Commission Directive 2013 / 46 / EU and Commission Regulation (EC) No 1243 / 2008. Commission Directive 2007 / 29 / EC of 30 May 2007 amending Directive 96 / 8 / EC as regards the labelling, advertising and presentation of foodstuffs for low energy nutrition for weight reduction. Commission Directive 2013 / 26 / EU of 8 February 2013 adapting certain Directives in the field of food safety and veterinary and phytosanitary policy by reason of the accession of Croatia.
(1a) Regulation (EC) No 396 / 2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91 / 414 / EEC, as amended. Commission Regulation (EC) No 2073 / 2005 of 15 November 2005 on microbiological criteria for foodstuffs, as amended. Regulation (EC) No 1924 / 2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods, as amended. Regulation (EC) No 1925 / 2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods, as amended. Commission Regulation (EC) No 1609 / 2006 of 27 October 2006 authorising the placing on the market of infant formulae based on whey protein hydrolysates derived from cows' milk proteins for a period of two years. Regulation (EC) No 1333 / 2008 of the European Parliament and of the Council of 16 December 2008 on food additives, as amended. Regulation (EU) No 1169 / 2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924 / 2006 and (EC) No 1925 / 2006 of the European Parliament and of the Council and repealing Commission Directive 87 / 250 / EEC, Council Directive 90 / 496 / EEC, Commission Directive 1999 / 10 / EC, Directive 2000 / 13 / EC of the European Parliament and of the Council, Commission Directives 2002 / 67 / EC and 2008 / 5 / EC and Commission Regulation (EC) No 608 / 2004, as amended. Commission Regulation (EU) No 231 / 2012 of 9 March 2012 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. Regulation (EU) No 609 / 2013 of the European Parliament and of the Council of 12 June 2013 on foodstuffs intended for infants and young children, foods for special medical purposes and total diet replacement for weight control and repealing Council Directive 92 / 52 / EEC, Commission Directives 96 / 8 / EC, 1999 / 21 / EC, 2006 / 125 / EC and 2006 / 141 / EC, Directive 2009 / 39 / EC of the European Parliament and of the Council and Commission Regulations (EC) No 41 / 2009 and (EC) No 953 / 2009, as amended. Commission Implementing Regulation (EU) No 828 / 2014 on requirements for the provision of information on the absence or reduced content of gluten in foodstuffs. ';
3. footnote 1b is deleted.
4. In Article 1, paragraphs 2 to 4, including footnote 1c, are deleted and the designation of paragraph 1 is deleted.
5. In Section 2, in the introductory part of the provision, the words "for particular nutritional uses' are deleted.
6. in Article 2 (a) to (c):
"(a) infant formulae and follow-on formulae and infant formulae,
(b) processed cereal-based foods and food for young children;
(c) total diet replacement for weight control, ';
7. in Paragraph 2, points (e) and (g) are deleted, point (f) is renumbered as point (e) and at the end of this point the comma is replaced by a dot.
8. Paragraph 3, including the title, shall be deleted.
9. The heading of Part Two shall read: "PARTICIPATION AND CONTINUATION OF EQUIVALENT EDUCATION AND EQUIVALENT OF SMALL CHILDREN."
10. Article 4 shall be deleted;
11. The heading of Section 5 reads: "Requirements for the composition of infant formulae and follow-on formulae and young children '.
12. Paragraph 5 (5), including footnote 1e, reads:
"(5) The directly applicable European Union regulation laying down specifications for food additives 1e shall apply mutatis mutandis to the purity requirements of the substances listed in Annex 3 to this Regulation.
1e) Commission Regulation (EU) No 231 / 2012, as amended. ';
13. in Article 5 (6), in the introductory part of the provision, the words "shall not contain any substance in such quantity as to endanger the health of infants or young children, in particular" shall be deleted.
14. in Article 5 (6) (a), including footnote 2:
"(a) must contain food additives only according to the directly applicable European Union Regulation on food additives (2);
(2) Regulation (EC) No 1333 / 2008 of the European Parliament and of the Council, as amended. ';
15. in Article 5 (6) (e), the word "continuation" shall be inserted after the words "for initial and";
16. Footnote 3a reads:
"(3a) Regulation (EC) No 396 / 2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91 / 414 / EEC."
17. The heading of Section 6 reads: "Labelling of infant formulae and follow-on formulae and dairy formulae for young children."
18. in Article 6 (1), in the introductory part of the provision, the words "and milk-based infant formula" shall be inserted after the words "infant formula."
19. In Article 6, at the end of paragraph 1, the dot is replaced by a comma and the following point (e) is added:
"(e)" dairy food for young children, "if it is intended for young children produced exclusively from cow's milk or goat's milk proteins."
20. In Article 6 (2), the introductory part of the provision reads: "The packaging of infant formulae and follow-on formulae and dairy formulae for young children shall be indicated."
21. in Article 6, the dot is replaced by a comma at the end of paragraph 2 and the following point (f) is added:
"(f) in the case of dairy products for young children, information that the food should only be part of a mixed and balanced diet for the small child.";
22. in Article 6 (4), the words "and dairy foods for young children" shall be inserted after the words "infant formulae."
23. in Article 6 (5), the word "dairy" shall be inserted after the words "infant formula";
24. in Article 6, paragraph 7 is deleted;
Paragraphs 8 to 10 shall be renumbered paragraphs 7 to 9.
25. in Article 6, paragraph 9 is deleted;
26. The heading of Part Three reads: "DIFFERENT FOOD AND FOOD FOR SMALL CHILDREN."
Article 27 (7) is deleted;
28. in Article 8 (1), "and other foods" shall be replaced by "foods and foods for young children."
29. in Article 8 (2), "and other foods" shall be replaced by "foods and foods for young children."
30. In Article 8 (3), the introductory part of the provision reads: "Processed cereal-based foods and foods for young children."
31. in Article 8 (3) (a):
"(a) must contain food additives only in accordance with the directly applicable European Union Regulation on food additives (2),"
32. in Article 8 (3) (d), the words "and other baby foods" shall be replaced by the words "baby foods and foods."
33. in Article 8 (3) (e), the words "for infant formulae and follow-on formulae" shall be deleted and the words "and other foods" shall be replaced by "foods and foods for young children."
34. The heading of Section 9 reads: "Labelling of processed cereal-based foods and foods for young children."
35. in Article 9 (1), the introductory part of the provision reads: "The packaging of cereal-based foods or foods for young children shall be indicated."
36. in Article 9 (2), "and other foods" shall be replaced by "foods and foods for young children."
37. The heading of Part 4 reads as follows: "REFUNDS TO THE WHOLE STRAW FOR THE REGULATION OF WEIGHT '.
38. Article 10 shall be deleted;
39. The heading of Section 11 reads: "Requirements for total diet replacement for weight control."
40. in Article 11 (1) and (2), the words "food for reducing diets" are replaced by the words "total diet for weight control."
41. in Article 11 (3), the words "and other substances" shall be replaced by the words "amino acids, carnitine and taurin, nucleotide, choline and inositol" and the words "food for reducing diets" shall be replaced by the words "total diet for weight reduction."
42. The heading of Section 12 reads: "Labelling of total diet substitutes for weight control."
43.Paragraph 12 (1) reads as follows:
"(1) Total diet replacement for weight control shall be labelled as" total diet replacement for weight reduction. "'
44. in § 12 (2), the introductory part of the provision reads: "Data shall be provided on the packaging of total diet for weight control."
45. in Article 12 (2) (b), the dot is replaced by the line after the word "dish" and the words "For foodstuffs covered by Article 10 (1) (b), the percentage of vitamin and minerals and their recommended daily dos5" shall be deleted, including footnote 5.
46. in Paragraph 12 (3):
"(3) The packaging of total diet for weight control shall indicate that:
(a) "may cause laxative effects in sensitive persons," if the use of the food according to the manufacturer's instructions leads to intake of polyols in excess of 20 g per day;
(b) adequate daily intake of fluids must be observed;
(c) the food provides all essential nutrients in the quantity required per day;
(d) the food should not be used without consulting the doctor for more than 3 weeks. "
47. in Paragraph 12 (4), the words "for a reduction diet" shall be replaced by the words "intended to replace a total diet for weight control."
48. In the title of Part 5, the word "DIETTE 'is deleted.
49. Paragraph 13 (1) is deleted.
Paragraphs 2 and 3 shall be renumbered paragraphs 1 and 2.
50. In Section 13 (1) of the Introductory Part of the provision, the words "Dietary foods' are replaced by the words" Food '.
51. in Paragraph 13 (2), "paragraph 2" is replaced by "paragraph 1";
52. In Section 14, Section 14 (1), (2), (3), Section 15 and Section 15 (3) and (4) in the introductory part of the provision, the word "diet" shall be deleted.
53. In Article 14 (3), the words "and other substances" are replaced by the words "amino acids, carnitine and taurine, nucleotide, choline and inositol."
54. Paragraph 15 (1) reads:
"(1) The name of the food for special medical purposes shall include the words" food for special medical purposes. "'.
55. The introductory part of Paragraph 15 (2) reads: "The packaging of food for special medical purposes shall contain the particulars."
56. in Article 15 (4) (a), "diet food" is replaced by "food."
57. Part 6 is deleted, including the title.
58. in Paragraph 22 (1) (b), the words "and in which the presence of free galactose is excluded" shall be deleted;
59. Paragraph 23, including the title and footnote 5, reads:
Labelling of low-lactose or lactose-free foods
In addition to the food information provided for in the Regulation on the provision of information5), information on lactose content in grams in 100 g or 100 ml of food shall be provided on the packaging of low-lactose or lactose-free foods.
(5) Regulation No 1169 / 2011 on the provision of food information to consumers, as amended. '
(60) Part 12, including the title, is deleted.
61. In Annex 7, in the table for the protein criterion in column Note, in point D, the words "and marked as such 'are inserted after the words" high protein content' and the word "higher 'is replaced by" lower'.
62. The heading of Annex No 8 reads: "Requirements for the basic composition of foodstuffs for young children."
63. The heading of Annex 9 reads: "Requirements for the identity of vitamins, minerals and other substances which can be used in the production of cereal-based foods and foods for young children."
64. In the title of Annex 10, the words "and others' and" intended for infant feeding 'are deleted and the words "young children' are replaced by the words" and food for young children '.
65. In the heading of Annex 11, the words "cereal-based foods and other foods other than cereal-based foods' are replaced by the words" processed cereal-based foods and ', the words "for infants' are deleted and the words" young children 'are replaced by the words "food for young children'.
66. In the title of Annex No 12, the words "cereal-based foods and other foods other than cereal-based foods' are replaced by the words" cereal-based foods', the words "infant food 'are deleted and the words" young children' are replaced by the words "foods for young children '.
67. The heading of Annex 15 reads: "Requirements for the composition of total diet replacement for weight control."
68. Table 1 of Annex 15:
"TABLE 1
1. Energy
| Množství energie v denní dávce musí být nejméně 3360 kJ (800 kcal) a nejvýše 5040 kJ (1200 kcal). |
2. Protein
| a) Bílkovinami obsaženými v potravině musí být dodáno nejméně 25 % a nejvýše 50 % energie, přičemž obsah bílkovin nesmí překročit 125 g v denní dávce. b) Požadavky stanovené v písmeni a) jsou vztaženy na bílkovinu, jejíž chemický index se rovná chemickému indexu referenční bílkoviny. Je-li chemický index směsi bílkovin přítomných v potravině nižší než 100 % chemického indexu referenční bílkoviny, musí být množství bílkovin v potravině odpovídajícím způsobem zvýšeno. Chemický index směsi bílkovin v potravině musí v každém případě činit 80 % indexu referenční bílkoviny. c) Chemickým indexem se rozumí nejnižší poměr mezi množstvím každé esenciální aminokyseliny ve směsné bílkovině potraviny tj. porovnávané bílkovině, a množstvím téže aminokyseliny v bílkovině referenční. d) Výhradně za účelem zvýšení výživové hodnoty bílkovin je povolen přídavek aminokyselin, a to pouze v množství pro tento účel nezbytném. |
3. Fats
| a) Množství energie v potravinách získané z tuků nesmí překročit 30 % celkového množství energie. b) Obsah kyseliny linolové ve formě glyceridů musí být nejméně 4,5 g v denní dávce. |
4. Fibres
| Obsah vlákniny musí být nejméně 10 g a nejvýše 30 g v denní dávce. |
5. Vitamins and minerals
| Obsah vitaminů a minerálních látek v denní dávce potraviny musí představovat nejméně 100 % hodnot, uvedených v tabulce č. 2.“. |
69. In Annex No 16, in the headings of Tables 1, 2 and 3, the word "diet 'is deleted.
70. In Annex No 16, Table 1, points 1 to 3 and 5 to 7, the text "Paragraph 13 (2) 'is replaced by" Paragraph 13 (1)'.
71. In Annex No 16, in Table 1, point 4, "12 'is replaced by" 13'.
72. At the end of footnote 7, the words "as amended 'shall be added.
Transitional provision
Dairy food for young children placed on the market or labelled in accordance with Decree No. 54 / 2004 Coll., as effective before the date of entry into force of the Decree, may be marketed until its stocks are exhausted.
Repeal
The following shall be deleted:
1. Decree No. 450 / 2004 Coll., on labelling of the nutritional value of foodstuffs.
2. Decree No. 330 / 2009 Coll., amending Decree No. 450 / 2004 Coll., on the labelling of the nutritional value of foodstuffs.
Final provision
This Decree was notified in accordance with Directive (EU) 2015 / 1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical and information society services.
Efficacy
This Decision shall enter into force on 1 April 2018.
Minister for Health:
Mgr. et Mgr. Vojtěch v. r.
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Regulation Information
| Citation | Decree No. 39 / 2018 Coll., amending Decree No. 54 / 2004 Coll., on foodstuffs intended for particular nutritional uses and their method of use, as amended |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 08.03.2018 |
|---|---|
| Effective from | 01.04.2018 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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