402/2006 Sb.
DECREE
of 31 March 2004. in July 2006,
amending Decree No 54/2004 Coll. on foodstuffs intended for
particular nutritional uses and how to use them
The Ministry of health shall, pursuant to section 19 para. 1 (b). and) and i)
Act No. 110/1997 Coll. on foodstuffs and tobacco products and amending
and the addition of some related laws, as amended by Act No. 308/2000
Coll., Act No. 274/2003 Coll. and Act No. 316/2004 Coll. (hereinafter referred to as
the "Act"):
Article. (I)
Decree No. 54/2004 Coll. on foodstuffs intended for particular nutritional uses and the
How to use them, is amended as follows:
1. In article 1, paragraphs 1 and 2, including the footnotes 1 and 1a shall be added:
"(1) this Ordinance" ^ 1 ") incorporates the relevant provisions of the European
Community ^ 1a) and modifies the requirements of the health food
intended for particular nutritional uses, their composition, labelling, and the terms and
How to use them.
(2) foodstuffs intended for particular nutritional uses, for the purposes of this order
means foods that are intended for nutritional purposes as laid down in
of this Ordinance and shall be shown in circulation with the indication ' intended use.
1) is released on the basis and within the limits of the law, whose content allows you to
to incorporate the relevant provisions of the European communities Decree.
1A) Council directive 1989/398/EEC of 3 May 1989. May 1989 on the approximation of
the legislation of the Member States relating to foodstuffs intended for
particular nutritional uses.
Directive of the European Parliament and of the Council of 1996/84/EC of 19 June 2000. December
1996, amending Directive 1989/398/EEC on the approximation of the laws
the laws of the Member States relating to foodstuffs intended for particular
nutrition.
European Parliament and Council Directive 1999/41/EC of 7 September 2004. June 1999,
amending Directive 1989/398/EEC on the approximation of the laws of the
of the Member States relating to foodstuffs intended for particular nutritional uses.
Commission Directive 2001/15/EC of 15 December 1999. February 2001 on substances that may
be added for specific nutritional purposes in foods for particular
nutrition.
Commission Directive 2004/5/EC of 20 May 1999. January 2004 amending
Directive 2001/15/EC to include certain substances in the annex.
European Parliament and Council Directive 2000/13/EC of 20 May 1999. March 2000
on the approximation of the laws of the Member States relating to the labelling of
food, presentation and advertising of foodstuffs.
Commission directive 1991/321/EEC of 14 June 1993 May 1991 on infant formulae and
follow-on formulae.
Commission directive 1996/4/EC of 16 December 2002. February 1996, amending
Directive 1991/321/EEC on infant formulae and follow-on formulae.
Commission Directive 1999/50/EC of 25 March 2002. in May 1999, amending the
Directive 1991/321/EEC on infant formulae and follow-on formulae.
Commission Directive 2003/14/EC of 10 June 1999. February 2003 amending
Directive 1991/321/EEC on infant formulae and follow-on formulae.
Commission directive 1996/5/EC of 16 December 2002. February 1996 on processed cereal-based
baby foods for infants and young children.
Commission Directive 1998/36/EC of 2 October 1998. June 1998 amending
Directive 1996/5/EC on processed cereal-based foods for infants and young
kids.
Commission Directive 1999/39/EC of 6 May 1999. in May 1999, which amends
Directive 1996/5/EC on processed cereal-based foods for infants and young
kids.
Directive 2003/13/EC of 10 June 1999. February 2003, which amended directive
1996/5/EC on processed cereal-based foods for infants and young children.
Council directive 1992/52/EEC of 18 June 1992. June 1992 on infant formulae and
follow-on formulae intended for export to third countries.
Commission directive 1996/8/EC of 26 July 2000. February 1996 on foods for
use in energy restricted diets for weight reduction.
Commission Directive 1999/21/EC of 25 March 2002. March 1999 on dietary
foods for special medical purposes.
Commission Directive 2004/6/EC of 20 May 1999. January 2004 derogating from
Directive 2001/15/EC to postpone the application of the ban, trading with certain
products. ".
Paragraphs 2 and 3 shall become paragraphs 3 and 4.
2. Appendix 1:
' Annex 13 to the No 54/2004 Sb.
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A dietary supplement the terms of use
-------------------------
All For AFP FSMPS ^ ^ # ##
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Category 1. Vitamins
------------------------------------------------------------------
VITAMIN A
-retinol x
retinol acetate x
retinol palmitate x
-beta-carotene x
VITAMIN D
-cholecalciferol x
-Vitamin x
VITAMIN E
-D-alpha-tocopherol x
-DL-alpha-tocopherol x
-D-alpha-tocopheryl acetate x
-DL-alpha-tocopheryl acetate x
-D-alpha-tocopheryl hydrogen succinate-x
-D-alpha-tocopheryl polyethylene glycol-x ^ *)
1000 succinate
VITAMIN K
-fyllochinon (fytomenadion) x
VITAMIN B1
-thiamin hydrochloride x
-thiamin mononitrate-x
VITAMIN B2
-riboflavin x
-riboflavin 5 '-phosphate, sodium salt x
NIACIN
-Nicotinic Acid
-NICOTINAMIDE x
PANTOTHENIC ACID
-D-CALCIUM PANTOTHENATE x
-D-PANTOTHENATE, sodium x
-dexpanthenol x
Vitamin B6
-pyridoxine hydrochloride x
-pyridoxine 5 '-phosphate x
-pyridoxine-dipalmitát
FOLIC ACID x
-pteroylmonoglutamová acid x
Vitamin B12
-vitamin B12 x
-hydroxokobalamin x
BIOTIN
-D-biotin x
VITAMIN C
-L-Ascorbic acid x
-L-ascorbate x
-L-ascorbate x
-L-ascorbate x
-L-askorbyl-6-palmitate x
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Category 2. Minerals
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CALCIUM
-carbonate x
-chloride x
-salts of citric acid x
-gluconate x
-glycerophosphate x
-lactate x
-x
-x
- oxid x
-sulphate x
MAGNESIUM
-x acetate
-carbonate x
-chloride x
-salts of citric acid x
-gluconate x
-glycerophosphate x
-lactate x
-x
-x
-carbon x
-sulphate x
-calcium pidolate (pidolát) x ^ *)
-amino acid chelate x ^ *)
IRON
-ferrous carbonate x
-ferrous citrate x
ferric ammonium citrate-ammonium-x
-ferrous gluconate x
ferrous fumarate-x
-dicalcium x
sodnoželezitý
-ferrous lactate x
-ferrous sulfate x
dicalcium diphosphate-x
-iron oxide with sucrose x
-Elemental iron (x
reduction with hydrogen or
electrolytically)
-ferrous hydroxide x ^ *)
-calcium pidolate (pidolát) x ^ *)
ferrous
-amino acid chelate x ^ *)
COPPER
-cupric carbonate x
-cupric citrate x
-copper gluconate x
-copper sulphate x
-copper lysine complex x
-amino acid chelate x ^ *)
JOD
-potassium iodide x
-potassium iodate x
sodium iodide-x
-sodium iodate x
ZINC
-x acetate
-chloride x
-citrate x
-gluconate x
-lactate x
- oxid x
-carbonate x
-sulphate x
-amino acid chelate x ^ *)
MANGANESE
-carbonate x
-chloride x
-citrate x
-gluconate x
-glycerophosphate x
-sulphate x
-amino acid chelate x ^ *)
SODIUM
-bicarbonate x
-carbonate x
-chloride x
-citrate x
-gluconate x
-glycerophosphate
-lactate x
-x
-x
POTASSIUM
-bicarbonate x
-carbonate x
-chloride x
-citrate x
-gluconate x
-glycerophosphate x
-lactate x
-x
-x
SELENIUM
-SODIUM SELENATE x
-sodium hydrogen selenite x
-sodium selenite x
-enriched yeast x ^ *)
CHROMIII and its hexahydrate
-chloride x
-sulphate x
-amino acid chelate x ^ *)
MOLYBDENVI
-ammonium molybdate x
-sodium molybdate x
FLUORINE
-potassium fluoride x
sodium fluoride-x
BOR
-boric acid x ^ *)
-Sodium Borate x ^ *)
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Category 3. Amino acids
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-L-alanine x
L-arginine-x
-L-arginine-L-aspartate x
-L-aspartic acid
-L-citrulline x
-L-cysteine x
-L-cysteine-N-acetate x
-cystine x
-L-Histidine x
-L-glutamic acid
-L-glutamine x
x-glycine
-L-isoleucine x
-L-Leucine x
-L-lysine x
-L-lysine acetate x
-L-lysine-L-aspartate x
-L-lysine-L-glutamate x
L-methionine-x
-L-methionine-acetate x ^ ^ **)
-L-ornithin x
-L-phenylalanine x
-L-PROLINE x
- L-serin x
-L-threonine x
-L-tryptophan x
-L-thyrosin x
-L-valine x
In the case of allowed amino acids
may also be used their sodium,
potassium and calcium salts and salts
manganese and their hydrochloridy
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Category 4. Carnitine and taurine
------------------------------------------------------------------
-L-carnitine x
-L-carnitine hydrochloride x
-L-carnitine L-tartrate-x
-taurine x
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Category 5. Nucleotides
-adenosine-5 '-phosphoric acid (AMP) x
— sodium salts of AMP x
-' Cytidine 5 '-monofosforečná acid
(CMP) x
— sodium salts of CMP x
-Guanosine-5 '-phosphoric acid (GMP) x
— sodium salts of GMP x
-inosine-5 '-phosphoric acid (IMP) x
— sodium salts of IMP x
-uridine-5 '-phosphoric acid (UMP) x
— sodium salts of UMP x
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Category 6. Choline and inositol
------------------------------------------------------------------
-choline x
-choline-chloride x
-choline-divinan x
-choline citrate x
-inositol x
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#) All for AFP means foods for particular nutritional uses including FSMPs
However, with the exception of the initial and follow-on formulae and of processed cereal-based
foods intended for infants and young children.
# #) FSMPS means dietary foods for special medical purposes.
x) shows the possibility of using the substance in for AFP or FSMPS.
*) Of the substance can be used in foodstuffs intended for particular nutritional uses not more than
until 31 December 2006. in December 2006, and under the assumption that the European
food safety authority has not given a negative opinion on using it
in the manufacture of food intended for particular nutritional uses and substance use
in the manufacture of one or more foods for particular nutritional uses
put into circulation in a member country of the European communities 11. February
2004.
**) Only in products intended for persons over 1 year. "
Article II
This Decree shall take effect on the date of its publication.
Minister:
Mudr. Rath v. r.
