157/2008 Sb.
DECREE
of 24 July 2003. April 2008,
amending Decree No. 54/2004 Coll. on foodstuffs intended for
particular nutritional uses and how to use them, as amended
the laws of the
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. 316/2004
Coll.:
Article. (I)
Decree 54/2004 Coll. on foodstuffs intended for particular nutritional uses and the
How to use them, as amended by Decree No. 402/2006 Coll. and Decree No.
473/2006 Coll., is amended as follows:
1. in article 1 paragraph 1 including the footnotes # 1, 1a and 1b is inserted:
"(1) this Ordinance" ^ 1 ") incorporates the relevant provisions of the European
Community ^ 1a) and modifies the following on directly applicable provisions of
Of the European communities ^ 1b) types of foods for particular nutritional uses,
requirements for the safety of foodstuffs intended for the Special
nutrition, their composition, labelling and conditions and how to use them.
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.
Commission Directive 2006/34/EC of 21 June 1999. March 2006 amending
the annex to Directive 2001/15/EC as regards the inclusion of certain substances.
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.
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 prohibition of trade to certain
products.
Commission Directive 2007/22/EC of 7 September 2004. May 2007 amending
Directive 2004/6/EC in order to extend the period of its use.
Commission Directive 2006/125/EC of 5 July 2004. December 2006 on processed cereal-based
baby foods for infants and young children.
Commission Directive 2006/141/EC of 22 December 2004. in December 2006, the initial and
follow-on formulae and amending Directive 1999/21/EC.
Commission Directive 2007/29/EC of 30 March 2004. May 2007 amending
Directive 96/8/EC, as regards labelling, advertising and presentation
foods for use in energy restricted diets for weight reduction.
1B) European Parliament and Council Regulation (EC) No 1924/2006 of 20 October.
December 2006 on nutrition and health claims in the labelling,
food.
European Parliament and Council Regulation (EC) No 1925/2006 of 20 October.
December 2006 on the addition of vitamins and minerals and of certain
other substances to foods.
Commission Regulation (EC) No 1609/2006 of 27 June. October 2006 on the
period of two years the placing on the market of infant formulae on
the base of the hydrolysates of whey protein derived from cows ' protein
milk.
Commission Regulation (EC) no 2073/2005 of 15 March. November 2005 on
microbiological criteria for foodstuffs.
Commission Regulation (EC) no 1441/2007 of 5 December. December 2007 laying
Commission Regulation (EC) no 2073/2005 on microbiological criteria
for the food. ".
2. In article 1 (1). 4, the words "food supplements" are replaced by the words "of Vitamins,
minerals and other substances with a nutritional or physiological effect
modified a directly applicable regulation of the European communities on
vitamins, minerals and other substances to the ^ 1 c) (hereinafter referred to as
"vitamins, minerals and other substances") ".
Footnote 1 c is inserted:
"1 c) European Parliament and Council Regulation (EC) No 1925/2006 of 20 October.
December 2006 on the addition of vitamins and minerals and of certain
other substances to foods. ".
3. in paragraph 2 of the letter j) shall be deleted and paragraph k) is referred to as
the letter j).
4. In section 4, paragraph 4. 1 c) and (d)):
"c) infant formulae food intended for particular nutritional uses
infants from birth to six months of age infants, which correspond to the
the nutritional requirements of this group of infants,
d) follow-on formulae food intended for particular nutritional uses
infants aged six months, constituting the principal liquid element in a share of
progressively diversified diet of infants. "
5. section 5, including the title and footnotes # 1 d, 1e, 2, 3 and 3a is added:
"§ 5
Requirements for the composition of foods for the initial and follow-on formula
Food and nutrition of young children
(1) the infant formulae shall be manufactured from protein sources referred to in
point 2 of annex 1 to this notice, and also of the other components, which
suitability for particular nutritional use by infants has been established by generally accepted
scientific knowledge.
(2) the follow-on formulae shall be manufactured from protein sources listed
in point 2 of annex 2 to this Decree, and also of the other components, which
suitability for particular nutritional use by infants over six months was
established by generally accepted scientific data.
(3) the composition of infant formulae and follow-on formulae
must be such that the preparation would require only the addition of water suitable for
infants ^ 1 d).
(4) the requirements for
and) the composition of infant formulae are laid down in annex 1 to the
This decree with regard to the specifications set out in table 1 of the annex
No. 6 to this Ordinance or in annex 14 to this Decree,
(b)) the composition of follow-on formulae are laid down in annex 2 to the
This decree with regard to the specifications set out in table 1 of the annex
No. 6 to this Ordinance,
(c)) use of vitamins, minerals and other substances are regulated by the
Annex No. 3 to this Decree,
(d) the content of the essential and conditionally) of the necessary amino acids in breast
milk are laid down in table 1 of the annex 6 to this Ordinance,
(e)) of the content source and the processing of protein for infant formula
produced from protein hydrolysates are regulated in annex No. 2 to the
This Decree.
(5) the requirements for the purity of the substances referred to in annex 3 to this notice
provides for a special law on health requirements for identity and
the purity of additives ^ 1e).
(6) the initial and follow-on formulae and nutrition of young children may not
contain any substance in such quantity as to endanger the health of infants
or small children, especially
and) must contain only those additives according to a special legal
Regulation laying down the types and conditions of the use of additives and
excipients ^ 2)
(b)) must comply with the microbiological requirements laid down directly applicable
Regulation of the European communities on microbiological criteria for
food ^ 3),
(c)) shall not contain residues of pesticides ^ 3a) in excess of the
the amount of 0.01 mg/kg of the product as proposed for consumption, or after a reset
According to the manufacturer's instructions for each individual pesticide,
(d)) for the production of infant formulae and follow-on formulae and of nutrition for
young children must not be used in agricultural products treated with pesticides,
which are covered in Appendix 11. For the agricultural product
untreated these pesticides is considered to be a product in which
1. content of pesticide residues laid down in table 1 of the annex No 11
the border shall not exceed 0.003 mg/kg, which is considered to be the limit of
of determination in establishing generally accepted standard
methods of testing,
2. the content of residues of the pesticides listed in table 2 of the annex No 11
the border shall not exceed 0.003 mg/kg, which is considered to be the limit of
of determination in establishing generally accepted standard
methods of testing,
(e)) must be the observance of specific maximum residue levels of pesticides or
metabolites of pesticides for starting and baby food and nutrition for the
small children, which are listed in annex 12 to this Decree.
(7) the content of pesticide residues and maximum limits laid down in
paragraph 6 (a). (d)), and (e)) shall apply to foods which are intended to
consumption or ready for use according to the manufacturer's instructions.
1-d), for example, Decree No. 275/2004 Coll. on quality requirements and
the wholesomeness of the bottled water and how to edit them, as amended by
Decree No. 404/2006 Coll.
1E), for example, Decree No. 54/2002 Coll. laying down health
requirements for the identity and purity of additives, as amended
legislation; Act 79/1997 Coll., on pharmaceuticals and amending and supplementing
some related laws, as amended.
2) Decree No. 4/2008 Coll. laying down the types and terms of use
additives and extraction solvents in food production.
3) of Commission Regulation (EC) no 2073/2005, Commission Regulation (EC) No.
1441/2007.
3A) Decree No. 381/2007 Coll., on the establishment of maximum residue
pesticides in food and raw materials. ".
6. section 6 including title and a footnote 4 is added:
"section 6
Food labelling for the initial and follow-on formulae and
nutrition of young children
(1) in the name of the food for the initial or follow-on formulae
must bear the words
and) "initial milk formulae", in the case of the initial baby
the food is made entirely from cows ' milk proteins,
(b)) ' follow-on milk formulae ", if it is a continuation
baby food made entirely from cows ' milk proteins,
(c)) "infant formulae", in the case of the other initial infant
nutrition,
(d)) "follow-on formulae", in the case of other continuation
baby food.
(2) in addition to the data referred to in the Act and in section 3 of the food packaging for
initial and follow-on formulae shall be
a) for infant formula information that the food is suitable for
nutritional use by infants from birth, if they cannot be breastfed
b) for follow-on formulae information that the food is suitable
only for infants over six months, further information that would
food should form only part of a diversified diet and should not be used as a
a substitute for breast milk during the first six months of life, and that
decisions on the initiation of baby foods, including any exceptions to
the rules of the age of six months should be taken only on the basis of
advice of a doctor or a person qualified in the field of nutrition, pharmacy
or mother and child care, depending on the individual growth and
the developmental needs of a particular infant,
(c)) for initial and follow-on formulae, the available energy
value expressed in kJ and kcal, and the content of proteins, in numerical form fats
and carbohydrate in 100 ml of the food ready for use according to the instructions
the manufacturer,
d) for initial and follow-on formulae, expressed in numerical form,
the average value of the content of the individual vitamins and minerals referred to in
Annexes 1 and 2 and, where appropriate, the average content of choline,
inositol, carnitine and taurine in 100 ml of the food ready for use
According to the manufacturer's instructions,
e) formulae and follow-on formulae, instructions for appropriate
preparation, storage and handling and the importance of
correct preparation and storage for the health of infants.
(3) the initial and follow-on formulae may indication
the figure of an average amount of nutrients in 100 ml of the food prepared
to use according to the manufacturer's instructions provided for in annex No. 3, if you already
This information is not given in accordance with paragraph 2 (a). (d)).
(4) for follow-on formulae in addition to numerical data may indicate
the amounts of vitamins and minerals also contain observations
the percentage of the reference values referred to in table 2 of the annex No 5
in 100 ml of the product ready for use according to the manufacturer's instructions.
(5) on the packaging of foods for infant formula can only be given
nutrition and health claims related to food ingredients referred to in
Annex No 4 to this Ordinance under the conditions there laid down. The conditions for the
nutrition or health claim in follow-on formulae
diet and nutrition for young children provides for a directly applicable regulation
Of the European communities on nutrition and health claims made on
food labelling ^ 4).
(6) part of the labelling of infant formulae is warning that
shall bear the words "important notice" or words having the same meaning and
the addition of text expressing the
and breastfeeding) priority before the infant formula products,
(b)) a recommendation that the product was used only on the basis of the doctor's recommendations
or a person qualified in the field of nutrition, pharmacy or care for the mother and
child.
(7) on the packaging of foods for infant formula may not be placed
pictures of infants, nor other images or statements that would idealizovalo
product; However, the graphical representations for the appropriate identification of the
the products and the representation of the method of preparation.
(8) on the packaging of foods for infant formula or follow-on
baby food should not be given the terms "humanized",
"maternizovaný", "modified" or similar terms.
(9) identification of foods for infant formula or follow-on
baby food must be carried out clearly so that the
avoid any risk of confusion, initial and follow-on formulae.
(10) the labelling of infant formulae or follow-on formulae
nutrition must be designed so as to provide the necessary information about
the appropriate use of the product, and this information should not discourage the
breastfeeding.
4) European Parliament and Council Regulation (EC) No 1924/2006 of 20 October.
December 2006 on nutrition and health claims in the labelling,
food. ".
7. In article 7 (2). 3, after the words "for Food", the words "grain
and ".
8. In section 8 paragraph 1. 1 (b). (b)), the words "food supplements and ingredients"
replaced by the words "of vitamins, minerals and other substances".
9. In section 8 paragraph 1. 3 letters and) and (b)):
"a) must only contain additives as set out by Decree, which is
laying down the types and conditions of the use of additives and extraction
solvents in the production of foodstuffs ^ 2)
(b)) must comply with the microbiological requirements laid down directly applicable
Regulation of the European communities on microbiological criteria for
food ^ 3), ".
10. In § 8 para. 3 (b). (d)), point 1, the words "the lower limit of determination"
replaced by the words "the limit of determination in establishing generally accepted
standardized methods ".
11. in section 9, paragraph 2 reads as follows:
"(2) on the packaging of processed cereal-based foods can also only be given
and the average quantity expressed in numerical form) for vitamins, minerals and
other substances listed in the annex No 9 in 100 g or 100 ml of the food,
as sold, and where appropriate, per specified quantity of food
ready for use according to the manufacturer's instructions, if this information is
not covered by paragraph 1 (b). (d)),
b) figures on vitamins and minerals listed in the table
No 1 of annex # 5 expressed as a percentage of the listed there
reference values in 100 g or 100 ml of the food as sold, and
If appropriate, per specified quantity of food ready for use
According to the manufacturer's instructions, if the quantities present represents
at least 15% of the reference values,
(c) a nutrition or health claim) under the conditions laid down directly
the applicable law of the European communities on nutrition and
health claims made on foods ^ 4). ".
12. In article 11 (1) 3 the words "food supplements" are replaced by the words
"Vitamins, minerals and other substances".
13. in § 12 para. 2 letter b) including footnote # 5 reads as follows:
"(b) the average quantity of each) of vitamins and minerals, for
the requirements which are set out in Appendix 15 to this Decree, in the 100
(g) or 100 ml of the food intended for use according to the manufacturer's instructions, or in the
the amount of the food, which replaces the one dish. For food
provided for in section 10 (1). 1 (b). (b)) shall be included in further data on the percentage of
vitamins and minerals and their recommended daily
benefits ^ 5),
5) Decree No. 450/2004 Coll., on the labelling of the nutritional value of food. ".
14. in section 12 paragraph 4 is added:
"(4) the labelling of foods for dieting may not contain an indication of the
rate or amount of weight loss as a result of its use. ".
15. in § 14 para. 3 the words "food supplements" are replaced by the words
"Vitamins, minerals and other substances".
16. in section 16 paragraph 2 reads as follows:
"(2) food without phenylalanine are intended for people with congenital,
genetically conditional metabolic phenylalanine. ".
17. in paragraph 17 (b)):
"(b)) about the content of vitamins, minerals and other substances by weight
units mikrog, mg or g per 100 g or 100 ml of the food, or
on the other, a suitable amount of the appropriate daily dose ^ 5) ".
18. in section 18 para. 2 (a). and) the words "value of gliadin in the final
food is no greater than 1 mg/100 g of dry matter marked as
"naturally gluten-free foods" "shall be replaced by" and in which the contents of the
gluten is a maximum of 20 mg/kg of food in the State designated for consumption,
or ".
19. in section 18 para. 2 (b)), and (c)):
"(b)) foods that contain ingredients from wheat or other types of
genus Tritium as spelt (
Triticum spelta l.
), kamut (
Tritium polonicum l.
) or hard wheat, barley, rye, oats, and of their hybrid varieties and
where the gluten content is less than 100 mg/kg of food in the State specified
for consumption, or
c) foods that contain ingredients or a mixture of ingredients referred to in
(a)), and (b)) and for which the gluten content is less than 100 mg/kg
food in the State designated for consumption. ".
20. in article 18, paragraph 3 reads:
"(3) gluten-free Foods are intended for people with an innate, genetically
conditional of prolamins of wheat, barley, rye and oats. ".
21. in section 19 (1):
"(1) foodstuffs may designate as" gluten-free "or" gluten free "
only if they meet the requirements set out in § 18 para. 2. ".
22. in section 19 para. 2 (b)):
"(b)) about the content of vitamins, minerals and other substances by weight
units mikrog, mg or g per 100 g or 100 ml of the food, or to
other suitable quantity, corresponding to a daily dose of ^ 5) ".
23. in paragraph 3 of section 19 reads as follows:
"(3) foodstuffs may designate as" gluten-free "only,
If they meet the requirements set out in § 18 para. 2 (a). a).“.
24. in paragraph 23 (b)):
"(b)) about the content of vitamins, minerals and other substances by weight
units mikrog, mg or g per 100 g or 100 ml of the food, or to
other suitable quantity, corresponding to a daily dose of ^ 5) ".
25. In paragraph 25 (b)):
"(b)) about the content of vitamins, minerals and other substances by weight
units mikrog, mg or g per 100 g or 100 ml of the food, or to
other suitable quantity, corresponding to a daily dose of ^ 5) ".
26. Section 11 shall be deleted.
27. in section 29, the words "food supplements" are replaced by the words "of Vitamins,
minerals and other substances ".
28. in paragraph 30 (d)):
"(d)) the indication of the content of vitamins, minerals and other substances in the
mass units mikrog, mg or g per 100 g or 100 ml
food, or to other appropriate amount, corresponding to a daily dose of ^ 5) ".
29. Annex No. 1 to 6 are added:
' Annex 1 to the Decree No 54/2004 Sb.
The essential composition of infant formulae prepared in accordance with the instruction
the manufacturer of the
(the values laid down in this Annex apply to the final product
ready for use, which is sold as such or prepared
According to the manufacturer's instructions)
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The CRITERION Of Minimum Maximum Note
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1. Energy 250 kJ/100 ml 295 kJ/100 ml (70 Vhodnostsložek shall be demonstrated in a systematic
(60 kcal/l00 kcal/100 ml) to review the available data on
ml) expected benefits and considerations of security, and
also, if necessary, by using the
the relevant studies carried out in the
According to generally accepted professional
guidelines on the form and method of preparation
takovýchstudií.
Vhodnostdalších folders specified for the
zvláštnívýživu by infants from birth has to be
established by generally accepted scientific
knowledge.
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2. Protein protein content = nitrogen content x 6.25
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2.1 infant 0.45 g/100 kJ 0.7 g/100 kJ for an equal energy value must
formulae manufactured (1.8 g/100 (3 g/100 kcal) infant formulae contain each
from cows ' milk proteins kcal) a necessary and conditionally necessary
the amino acid at least equal to
an available quantity of what is contained in the
the reference protein given in annex No 6
Table No. 1.
When calculating the concentration of methionine can
and cystine sum, if the ratio of methionine to
cystine does not exceed a value of 2, it is also
they can add up the concentration of phenylalanine and
Tyrosine tyrosine ratio to
phenylalanine does not exceed a value of 2. If
It is the suitability of the product for infants
demonstrated relevant studies
drawn up in accordance with generally
accepted professional guidelines as to the form
and how the development of such studies, the
the ratio of methionine cystine to be greater than 2,
but may not exceed a value of 3.
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2.1.1 infant 0.45/100 kJ 0.5 g/100 kJ (2.0 in infant formula made from
formulae manufactured from protein (1.8 g/100 g/100 kcal) bílkovinkravského milk with a protein content
cow's milk kcal) in the range between the minimum and 0.5
g/100 kJ (2 g/100 kcal), the suitability of the
infant formulae for special
infants demonstrated through
the relevant studies carried out in the
According to generally accepted professional
guidelines on the form and method of preparation
takovýchstudií.
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2.2 infant 0.45 g/100 kJ 0.7 g/100 (3 g/100
formulae manufactured kJ (1.8 g/100 kcal) for an equal energy value must
protein hydrolysates kcal) infant formulae contain each
an indispensable and conditionally indispensable
the amino acid at least equal to an available
the quantity of what is contained in the reference
protein (breast milk, as defined in annex
# 6 of table 1). In the calculation may
the concentration of methionine and cystine sum
If the ratio of methionine to cystine does not exceed
a value of 2, and so can add up
concentration of phenylalanine and tyrosine, if
the ratio of phenylalanine to tyrosine does not exceed
a value of 2. If the suitability of the product for the
nutritional use by infants is demonstrated by the corresponding
studiemivypracovanými in accordance with the
the generally accepted professional guidelines
as to the form and method of preparation
takovýchstudií may be the ratio of methionine to
cystine is more than 2, but shall not exceed
a value of 3.
L-carnitine content shall be at least 0.3
mg/100 kJ (1.2 mg/100 kcal).
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2.2.1 infant 0.45 g/100 0.56 g/100 kJ (2.25 for infant formula made from
formulae manufactured kJ (1.8 g/100 g/100 kcal), protein hydrolysates with a protein content
protein hydrolysates kcal) in the range between the minimum and 0.56
g/100 kJ (2,25 g/100 kcal), the suitability of the
infant formulae for special
infants demonstrated through
the relevant studies carried out in the
According to generally accepted professional
guidelines on the form and method of preparation
takovýchstudií and must be in accordance with the
the corresponding specifications referred to in
Annex No 14 of this Ordinance.
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2.3 infant 0.56 g/100 kJ 0.7 g/100 kJ (3 g/100 in the manufacture of infant formulae
formulae manufactured from isolates of 2.25 g/100 kcal) only protein isolates are used from soy.
soya proteins, kcal) for an equal energy value must
alone or in a mixture with infant formulae contain each
cows necessary and conditionally necessary
milk amino acid at least equal to an available
the quantity of what is contained in the reference
protein (breast milk, as defined in annex
# 6 of table 1). In the calculation, however, may
the concentration of methionine and cystine sum
If the ratio of methionine to cystine does not exceed
a value of 2, and so can add up
concentration of phenylalanine and tyrosine, if
the ratio of phenylalanine to tyrosine does not exceed
a value of 2. If the suitability of the product for the
nutritional use by infants is demonstrated by the corresponding
studiemivypracovanými in accordance with the
the generally accepted professional guidelines
as to the form and method of preparation
takovýchstudií may be the ratio of methionine to
cystine is more than 2, but shall not exceed
a value of 3.
L-carnitine content shall be at least 0.3
mg/100 kJ (1.2 g/100 kcal).
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2.4 in all cases, amino acids to infant formulae added solely for the improvement of
the nutritional value of the proteins, and only in the proportions necessary for that purpose.
-------------------------------------------------------------------- -------------------------------------------------
3. Taurine (added) 2.9 mg/100 kJ (12
mg/100 kcal)
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4. Choline 1.7 mg/100 kJ 12 mg/100 kJ
(7 mg/100 kcal) (50 mg/100 kcal)
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5. Fats in 1.05 g/100 1.4 g/100 kJ (6.0
kJ (4.4 g/100 g/100 kcal)
kcal)
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5.1 it is forbidden the use of the following substances:
-sesame seed oil,
-cotton-seed oil.
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5.2 lauric acid and — individually or together:
myristová acid, 20% of the total fat content
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5.3 content of trans-isomers of fatty acids should not be greater than 3% of the total fat content.
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5.4 the erucic acid content shall not exceed 1% of the total fat content.
-------------------------------------------------------------------- -------------------------------------------------
5.5 linoleic acid (in the 70 mg/100 kJ 285 mg/100 kJ (1200 mg/100 kcal)
the form of glycerides = (300 mg/100
linoleates) kcal)
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5.6 the alpha-linolenic acid content shall be less than 12 mg/100 kJ (50 mg/100 kcal). The ratio of linoleic acid to
alpha-linolenic acid must be at least 5 and not more than 15.
-------------------------------------------------------------------- -------------------------------------------------
5.7 you may add polyunsaturated fatty acids long-chain (20 and 22 carbon atoms). In this case,
their content must not be in the overall fat content greater than:
-1% for n-3 polyunsaturated fatty acids with long chain and
-2% for the n-6 Polyunsaturated fatty acids with long chain
(1% for acid arachidonovou (20:4 n-6)).
The content of Eicosapentaenoic Acid (20:5 n-3) content shall not exceed that of Docosahexaenoic acid (n-3 22:6).
Docosahexaenoic acid content (22:6 n-3) content shall not exceed that of n-6 Polyunsaturated fatty acids with long
string.
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6. Phospholipids 2 g/l
-------------------------------------------------------------------- -------------------------------------------------
7. Inositol 1 mg/100 kJ 10 mg/100 kJ (39 mg/100 kcal)
(4 mg/100
kcal)
-------------------------------------------------------------------- -------------------------------------------------
8. Carbohydrates 2.2 g/100 3.4 g/100 kJ (14 g/100 kcal) shall be used only
kJ (7 g/100 carbohydrates:
kcal)-lactose,
-maltose,
— sucrose,
— glucose,
— maltodextrins,
— glucose syrup or dried
glucose syrup,
— having parboiled starch-naturally
gluten-free,
-gelling starches-natural
gluten-free.
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8.1 Lactose 1.1 g/100 — this provision shall not apply to
kJ (4.5 g/100 infant formula, in
kcal) that soya protein isolates
represent more than 50% of the
the total protein content.
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8.2. Sucrose (added) 20% of the total carbohydrate content can only add Sucrose
in the case of infant formulae
produced from hydrolyzed
protein.
-------------------------------------------------------------------- -------------------------------------------------
8.3 the glucose (added) 0.5 g/100 kJ (2 g/100 kcal) Glucose, you can add only
in the case of infant formulae
produced from hydrolyzed
protein.
-------------------------------------------------------------------- -------------------------------------------------
5.2 having parboiled and/or-2 g/100 ml, and 30%
gelling the starch from the total content
carbohydrates
-------------------------------------------------------------------- -------------------------------------------------
9. Fruktooligosacharidy and 0.8 g/100 ml other combinations and maximum
galaktooligosacharidy in combination with 90% of the value of the fruktooligosacharidů and
oligogalaktosyl-galaktooligosacharidů it is possible
lactose and 10% use in accordance with § 5 para. 1
oligofruktosyl-this order.
sucrose, high-
molecular weight
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10. Mineral substances
-------------------------------------------------------------------- -------------------------------------------------
10.1 infant formulae manufactured from protein/100 kJ per 100 kcal
cow's milk or protein hydrolysates
-------------------------------------------------------------------- -------------------------------------------------
Mineral Unit Minimum Maximum MinimumMaximum
-------------------------------------------------------------------- -------------------------------------------------
Sodium (mg) 5 14 20 60
Potassium (mg) 15 38 60 160
Chloride (mg) 12 38 50 160
Calcium (mg) 12 33 50 140
Phosphorus (mg) 6 22 25 90
Magnesium (mg) 1.2 3.6 5 15
Iron (mg) 0.07 0.3 0.3 1.3
Zinc (mg) 0.12 0.36 0.5 1.5
Copper (mikrog) 8.4 25 35 100
Iodine (mikrog) 2.5 12 10 50
Selenium (mikrog) 0.25 2.2 1 9
Manganese (mikrog) 0.25 25 1 100
Fluoride (mikrog) — 25 — 100
-------------------------------------------------------------------- -------------------------------------------------
The ratio of calcium to phosphorus should not be less than 1.0 nor greater than 2.0.
-------------------------------------------------------------------- -------------------------------------------------
10.2 infant formulae manufactured from soya protein isolates, samotnýchnebo with proteins in the mixture
cow's milk
All requirements of point 10.1 shall apply, with the exception of the requirements for iron and phosphorus, which are the following:
-------------------------------------------------------------------- -------------------------------------------------
Iron (mg) 0.12 0.5 0.45 2
Phosphorus (mg) 25 30 100 7.5
-------------------------------------------------------------------- -------------------------------------------------
11. vitamins On 100 kJ Per 100 kcal
-------------------------------------------------------------------- -------------------------------------------------
Vitamin Unit Minimum Maximum Minimum Maximum
-------------------------------------------------------------------- -------------------------------------------------
Vitamin A (mikrog-RE) (*} 14 43 60 180
Vitamin D (mikrog) (0.25 0.65 1 2.5 **
Thiamin (mikrog) 14 72 60 300
Riboflavin (mikrog) 19 95 80 400
Niacin (mikrog) (***} 72 375 300 1 500
Pantothenic acid (mikrog) 95 475 400 2 000
Vitamin B6 (mikrog) 9 42 35 175
Biotin (mikrog) 0.4 1.8 1.5 7.5
Folic acid (mikrog) 2.5 12 10 50
Vitamin B12 (mikikrog) 2.5 7.5 10 30
Vitamin K (mikrog) 1 6 4 25
Vitamin E (mg Alpha-TE) (****) 0,5/g (* *** *} 1.2 0,5/g (* * * * * *} 5
-------------------------------------------------------------------- ------------------------------------------------- TE)(****}
12. Nucleotides
-------------------------------------------------------------------- -------------------------------------------------
Maximum (* *** ***}
(mg/100 kJ) (mg/100 kcal)
-------------------------------------------------------------------- -------------------------------------------------
' Cytidine 5 '-monophosphate 0.60 2.50
uridine 5 '-monophosphate 0.42 1.75
adenosine 5 '-monophosphate 0.36 1.50
Guanosine 5 '-monophosphate 0.12 0.50
inosine 5 '-monophosphate 0.24 1.00
-------------------------------------------------------------------- -------------------------------------------------
(*) Re = all trans retinol equivalent.
(**) In the form of cholecalciferol, of which 10 mikrog = 400 i.u. of vitamin d.
(***) Preformovaný niacin.
(****) alpha-TE = d-alpha-tocopherol equivalent
(* ****), polyunsaturated fatty acids,
expressed as linoleic acid and adjusted according to the number of double bonds
links * * * * * * * *}, but in no case less than 0.1 mg/100
usable kJ
(* * * * * *) polyunsaturated fatty acids,
expressed as linoleic acid and adjusted in accordance with
the number of double bonds (* * * * * * * *},
in any case, not less than 0.5
mg/100 kcal of usable
(* * * * * * *) the total concentration of nucleotides shall not be
more than 1.2 mg/100 kJ (5 mg/100 kcal)
(* * * * * * * *) 0.5 mg Alpha-TE/1 g linoleic acid (18:2 n-6)
0.75 mg Alpha-TE/1 g alpha-linolenic acid (n-3 18:3)
1.0 mg Alpha-TE/1 g arachidonic acid (20:4 n-6)
1.25 mg Alpha-TE/1 g Eicosapentaenoic Acid (n-3 20:5)
1.5 mg Alpha-TE/1 g Docosahexaenoic acid (n-3 22:6)
"Annex 2 to the Decree No 54/2004 Sb.
Essential composition of follow-on formulae prepared in accordance with the instruction
the manufacturer of the
(the values laid down in this Annex apply to the final product
ready for use, which is sold as such or prepared
According to the manufacturer's instructions)
---------------------------------------------------- ------------------------------------------------------------------
The Criterion Of Minimum Maximum Note
---------------------------------------------------- ------------------------------------------------------------------
1. Energy 250 kJ/100 ml 295 kJ/100 ml of the suitability of the components shall be demonstrated in a systematic review
(60 kcal/100 (70 kcal/100 available data regarding the expected benefits and considerations
ml) ml) security, and also, if necessary, using the corresponding
studies carried out in accordance with generally accepted professional
guidelines on the form and way of development of such studies.
The suitability of other components intended for particular nutritional use by infants from
the birth must be established by generally accepted scientific
knowledge.
---------------------------------------------------- ------------------------------------------------------------------
2. Protein protein content = nitrogen content x 6.25
---------------------------------------------------- ------------------------------------------------------------------
2.1 Follow-on 0.45 g/100 0.8 g/100 for the same energy value must jump nutrition
formulae manufactured from kJ (1.8 g/100 kJ (3.5 contain each necessary and conditionally essential amino acid
protein of cow kcal) g/100 kcal) at least in the same an available quantity of what is contained in the
the milk of the reference protein (breast milk, as defined in annex No 6
table 1 of this order). In the calculation, however, may
the concentration of methionine and cystine sum, if the ratio of methionine
for cystine does not exceed 3, and so can add up
concentration of phenylalanine and tyrosine tyrosine ratio to
phenylalanine does not exceed a value of 2.
---------------------------------------------------- ------------------------------------------------------------------
2.2 Continuation 0.56 g/100 kJ 0.8 g/100 for the same energy value must jump nutrition
formulae manufactured from (2.25 g/100 kJ (3.5 contain each necessary and conditionally essential amino acid
hydrolysed kcal) g/100 kcal) at least in the same an available quantity of what is contained in the
protein reference protein (breast milk, as defined in annex No 6
table 1 of this order). In the calculation, however, may
the concentration of methionine and cystine sum, if the ratio of methionine
for cystine does not exceed 3, and so can add up
concentration of phenylalanine and tyrosine tyrosine ratio to
phenylalanine does not exceed a value of 2.
---------------------------------------------------- ------------------------------------------------------------------
2.3 Follow-on 0.56 g/100 kJ 0.8 g/100 sepoužívají when producing the nutrition only soya isolates
formulae manufactured from (2.25 g/100 kJ (3.5 protein.
soy isolates kcal) g/100 kcal) for an equal energy value must jump nutrition
proteins themselves contain every necessary and conditionally essential amino acid
or in a mixture with an available quantity at least equal to that contained in the
protein reference protein (breast milk, as referred to in annex No 6
cow's milk table 1 of this order). In the calculation, however, may
the concentration of methionine and cystine sum, if the ratio of methionine
for cystine does not exceed 3, and so can add up
concentration of phenylalanine and
Tyrosine, phenylalanine to tyrosine ratio does not exceed a value of 2.
---------------------------------------------------- ------------------------------------------------------------------
2.4 in all cases, amino acids to follow-on formulae
added solely for improving the nutritional value of the proteins, and only in the proportions necessary for that purpose.
---------------------------------------------------- ------------------------------------------------------------------
3. Taurine (added) 2.9 mg/100 kJ (12
mg/100 kcal)
---------------------------------------------------- ------------------------------------------------------------------
4. Fats 0.96 g/100 1.4 g/100
kJ (4.0 kJ (6.0
g/100 kcal) g/100 kcal)
---------------------------------------------------- ------------------------------------------------------------------
4.1 it is forbidden the use of the following substances:
-sesame seed oil,
-cotton-seed oil.
---------------------------------------------------- ------------------------------------------------------------------
4.2 lauric acid-individually or
and acid together: 20%
myristová of total content
fat
---------------------------------------------------- ------------------------------------------------------------------
4.3 content of trans-isomers of fatty acids should not be greater than 3% of the total
fat content.
---------------------------------------------------- ------------------------------------------------------------------
4.4 the erucic acid content shall not exceed 1% of the total fat content.
---------------------------------------------------- ------------------------------------------------------------------
4.5 Acid 70 mg/100 285 mg/100
Linoleic kJ (300 kJ (1 200
(in the form of mg/100 kcal) mg/100 kcal
glycerides
=
linoleates)
---------------------------------------------------- ------------------------------------------------------------------
4.6 the alpha-linolenic acid content shall be less than 12 mg/100 kJ (50 mg/100 kcal). The ratio of the
linoleic acid to alpha-linolenic acid must be at least 5 and not more than 15.
---------------------------------------------------- ------------------------------------------------------------------
4.7 may add polyunsaturated fatty acids long-chain (20
and 22 carbon atoms). In this case, the content must not be in the overall
fat content greater than:
-1% for n-3 polyunsaturated fatty acids with long chain and
-2% for the n-6 Polyunsaturated fatty acids with long chain
(1% for acid arachidonovou (20:4 n-6)).
The content of Eicosapentaenoic Acid (20:5 n-3) content shall not exceed that of Docosahexaenoic acid (n-3 22:6).
Docosahexaenoic acid content (22:6 n-3) content shall not exceed that of n-6 Polyunsaturated fatty acids
long chain.
---------------------------------------------------- ------------------------------------------------------------------
5. Phospholipids 2 g/l
---------------------------------------------------- ------------------------------------------------------------------
6. Carbohydrates 2.2 g/100 kJ 3.4 g/100 kJ Is forbidden to use the folder
(9 g/100 (14 g/100 kcal) that contains gluten.
kcal)
---------------------------------------------------- ------------------------------------------------------------------
6.1 Lactose 1.1 g/100 kJ — this provision shall not apply to
4.5 g/100 kojeneckouvýživu in a follow-on
kcal that isolates of sójovýchbílkovin
represent more than 50% of the
the total protein content.
---------------------------------------------------- ------------------------------------------------------------------
6.2 sucrose,
fructose, honey-individually or honey must be treated so that they are
together: 20% destroyed the spores of Clostridium
of the total content of botulinum.
carbohydrates
---------------------------------------------------- ------------------------------------------------------------------
6.3 glucose (added) 0.5 g/100 kJ (2 Glucose, you can add only
g/100 kcal) up to follow-on formulae
produced from hydrolyzed
protein.
---------------------------------------------------- ------------------------------------------------------------------
7. Fruktooligosacharidy and 0.8 g/100 ml in the other combinations and maximum
galaktooligosacharidy combination of 90% of the value of the fruktooligosacharidů and
oligogalaktosyl-galaktooligosacharidů it is possible
lactose and 10% use in accordance with § 5 para. 2
oligofruktosyl-this order.
sucrose, high-
Molecular
the weight of the
---------------------------------------------------- ------------------------------------------------------------------
8. Mineral substances
---------------------------------------------------- ------------------------------------------------------------------
8.1 Follow-on formulae manufactured from protein
cow's milk
or protein hydrolysates
---------------------------------------------------- ------------------------------------------------------------------
on 100 kJ on 100 kcal
------------------ ---------------------
Mineral Unit Minimum Maximum Minimum Maximum
---------------------------------------------------- -----------------------------------------
Sodium (mg) 5 14 20 60
Potassium (mg) 15 38 60 160
Chloride (mg) 12 38 50 160
Calcium (mg) 12 33 50 140
Phosphorus (mg) 6 22 25 90
Magnesium (mg) 1.2 3.6 5 15
Iron (mg) 0.14 0.5 0.6 2
Zinc (mg) 0.12 0.36 0.5 1.5
Copper (mikrog) 8.4 25 35 100
Iodine (mikrog) 2.5 12 10 50
Selenium (mikrog) 0.25 2.2 1 9
Manganese (mikrog) 0.25 25 1 100
Fluoride (mikrog) — 25 — 100
The ratio of calcium to phosphorus should not be less than 1.0 nor greater than 2.0.
---------------------------------------------------- ------------------------------------------------------------------
8.2 Follow-on formulae manufactured from soya protein isolates, alone or in a mixture with
cows ' milk proteins
All requirements of point 8.1 shall apply, with the exception of the requirements on iron and phosphorus, which are these
---------------------------------------------------- -----------------------------------------
Iron (mg) 0.22 0.65 0.9 2.5
Phosphorus (mg) 25 30 100 7.5
---------------------------------------------------- ------------------------------------------------------------------
9. vitamins On 100 kJ Per 100 kcal
---------------------------- -------------------------------------------------------------------------
Vitamin Unit Minimum Maximum Minimum Maximum
---------------------------- -------------------------------------------------------------------------
Vitamin A (mikrog-RE) (*) 14 4360 180
Vitamin D (mikrog) (* *) 0.25 0.751 3
Thiamin (Mg) 14 7260 300
Riboflavin (mikrog) 19 9580 400
Niacin (mikrog) (* * *) 72 375300 1 500
Pantothenic acid (mikrog) 95 475400 2 000
Vitamin B6 (Mg) 9 4235 175
Biotin (MS) 0.4 1, 81, 5, 7.5
Folic acid (Mg) 2.5 1210 50
Vitamin B12 (mikrog) 0.025 0, 120, 1 0.5
Vitamin C (mg) 2.5 7.510 30
Vitamin K (mikrog) 1 64 25
Vitamin E (mg Alpha-TE) (* * *) (*) 0,5/g (* ****) 1, 20, 5/g (* * * * * *) 5
---------------------------------------------------- ------------------------------------------------------------------
10. A maximum of Nucleotides (* * * * * * *)
(mg/100 kJ) (mg/100 kcal)
------------------------------------------
' Cytidine 5 '-monophosphate 0.60 2.50
uridine 5 '-monophosphate 0.42 1.75
adenosine 5 '-monophosphate 0.36 1.50
Guanosine 5 '-monophosphate 0.12 0.50
inosine 5 '-monophosphate 0.24 1.00
---------------------------------------------------- ------------------------------------------------------------------
(*) Re = all trans retinol equivalent.
(**) In the form of cholecalciferol, of which 10 mikrog = 400 i.u. of vitamin d.
(***) Preformovaný niacin.
(****) alpha-TE = d-alpha-tocopherol equivalent.
(* ****) polyunsaturated fatty acids expressed as linoleic acid
and adjusted for the number of double bonds (* * * * * * * *},
However, in no case less than 0.1 mg/100 kJ usable.
(* * * * * *) of polyunsaturated fatty acids expressed as linoleic acid
and adjusted for the number of double bonds (* * * * * * * *},
in any case, not less than 0.5 mg/100 kcal usable.
(*******) The total concentration of nucleotides shall not exceed 1.2 mg/100kJ (5 mg/100 kcal).
(* * * * * * * *) 0.5 mg Alpha-TE/1 g linoleic acid (18:2 n-6);
0.75 mg Alpha-TE/1 g alpha-linolenic acid (n-3 18:3);
1.0 mg Alpha-TE/1 g arachidonic acid (20:4 n-6);
1.25 mg Alpha-TE/1 g Eicosapentaenoic Acid (20:5 n-3);
1.5 mg Alpha-TE/1 g Docosahexaenoic acid (n-3 22:6).
"Appendix No. 3 to Decree No. 54/2004 Coll.
Vitamins, minerals and other substances
Table No. 1
Vitamins
------------------------- ---------------------------------------
The chemical name of vitamin vitamin
------------------------- ---------------------------------------
Vitamin A retinylacetát
retinylpalmitát
retinol
------------------------- ---------------------------------------
Vitamin D vitamin D2 (ergocalciferol)
Vitamin D3 (cholecalciferol)
------------------------- ---------------------------------------
Vitamin B1 thiamin hydrochloride
thiamine mono nitrate
------------------------- ---------------------------------------
Vitamin B2 riboflavin
Riboflavin-5 '-phosphate sodium
------------------------- ---------------------------------------
Niacin or NICOTINAMIDE
Nicotinic Acid
------------------------- ---------------------------------------
Vitamin B6 or pyridoxine hydrochloride
pyridoxine 5 '-phosphate
------------------------- ---------------------------------------
Folic acid folic acid
------------------------- ---------------------------------------
Pantothenic acid D-calcium pantothenát
D-sodium pantothenát
dexpanthenol
------------------------- ---------------------------------------
Vitamin B12 cyanocobalamin
hydroxocobalamin
------------------------- ---------------------------------------
Biotin D-biotin
------------------------- ---------------------------------------
Vitamin C L-Ascorbic acid
L-ascorbate
L-ascorbate
6-palmityl-L-Ascorbic acid
(ASCORBYL PALMITATE)
ascorbate
------------------------- ---------------------------------------
Vitamin E D-alpha-tocopherol
DL-alpha-tocopherol
D-alpha-tokoferylacetát
DL-Alpha-tokoferylacetát
------------------------- ---------------------------------------
Vitamin K fylochinon (fytomenadion)
------------------------- ---------------------------------------
Table No. 2
Mineral substances
Mineral salt Allowed
------------------------- ---------------------------------------
Calcium (Ca) calcium carbonate
calcium chloride
calcium salts of citric acid
Calcium Gluconate
calcium glycerolfosforečnan
calcium lactate
calcium salts of orthophosphoric acid
calcium hydroxide
------------------------- ---------------------------------------
Magnesium (Mg) magnesium carbonate
magnesium chloride
magnesium oxide
magnesium salts of orthophosphoric acid
magnesium sulfate
magnesium gluconate
magnesium hydroxide
magnesium salts of citric acid
------------------------- ---------------------------------------
Iron (Fe) ferrous citrate
ferrous gluconate
ferrous lactate
ferrous sulfate
ferric ammonium citrate and ammonium
ferrous fumarate
dicalcium diphosphate
(ferric pyrophosphate)
bisglycinát ferrous
------------------------- ---------------------------------------
Copper (Cu) cupric citrate
cupric gluconate
copper sulphate
copper-lysine complex
cupric carbonate
------------------------- ---------------------------------------
Iodine (I) potassium iodide
sodium iodide
potassium iodate
------------------------- ---------------------------------------
Zinc (Zn) zinc acetate
Zinc chloride
Zinc lactate
zinc sulphate
Zinc citrate
zinc gluconate
zinc oxide
------------------------- ---------------------------------------
Manganese (Mn) manganese carbonate
manganese chloride
manganese citrate
manganese sulphate
manganese gluconate
------------------------- ---------------------------------------
Sodium (Na) sodium bicarbonate
sodium chloride
sodium citrate
sodium gluconate
sodium carbonate
sodium lactate
sodium salts of orthophosphoric acid
sodium hydroxide
------------------------- ---------------------------------------
Potassium (K) potassium bicarbonate
potassium carbonate
potassium chloride
potassium salts of citric acid
potassium gluconate
potassium lactate
potassium salts of orthophosphoric acid
potassium hydroxide
------------------------- ---------------------------------------
Selenium (Se), SODIUM SELENATE
sodium selenite
------------------------- ---------------------------------------
Table 3
------------------------- ----------------------------
Amino acids and other nitrogen compounds
------------------------- ----------------------------
L-cystine and L-cystine hydrochloride
L-Histidine and L-Histidine hydrochloride
L-isoleucine and L-isoleucine
L-Leucine and L-Leucine
L-lysine and L-lysine hydrochloride
L-cysteine and L-cysteine hydrochloride
L-methionine
L-phenylalanine
L-threonine
L-tryptophan
L-tyrosine
L-valine
L-carnitine and L-carnitine hydrochloride
L-carnitine L-tartrate
taurine
' Cytidine 5 '-monophosphate and its sodium salt
uridine 5 '-monophosphate and its sodium salt
adenosine 5 '-monophosphate and its sodium salt
Guanosine 5 '-monophosphate and its sodium salt
inosine 5 '-monophosphate and its sodium salt
------------------------- ----------------------------
Table 4
----------------------
Other nutritional substances
----------------------
choline
choline chloride
citrate
choline
dvojvinan
choline
inositol
----------------------
' Annex # 4 to # 54/2004 Sb.
Nutrition and health claims for infant formula in force and
the conditions for their use
Table No. 1
------------------------------------------- ------------------------------------------------
Nutrition claims
------------------------------------------- ------------------------------------------------
Nutrition claim related to the conditions for their use
------------------------------------------- ------------------------------------------------
Lactose only lactose is the only carbohydrate present
------------------------------------------- ------------------------------------------------
the absence of lactose lactose content does not exceed 2.5 mg/100 kJ
(10 mg/100 kcal).
------------------------------------------- ------------------------------------------------
The addition of polyunsaturated fatty acids Docosahexaenoic acid content represents the
long chain or equivalent at least 0.2% of the total fatty
nutritional claims relating to the addition of acids
Docosahexaenoic acid
------------------------------------------- ------------------------------------------------
The content of taurine Optionally added in quantities suitable for
the intended use for infants and in accordance with the
the conditions laid down in annex 1 to this
the Decree.
The content of fruktooligosacharidů and
galaktooligosacharidů
The contents of nucleotides
------------------------------------------- ------------------------------------------------
Table No. 2
Health claims
------------------------------------------- ------------------------------------------------
Health claims and conditions for their use
(including reduced-risk claims
a disease) relative to the
------------------------------------------- ------------------------------------------------
Reduce the risk of allergy to milk proteins; On the evidence of the properties listed in the claim must
in this health claim may be used be available objective and scientifically proven
the terms referring to reduced allergen content knowledge.
or decreased antigenic properties. Infant formulae must comply with the
the provisions set out in point 2.2 of Annex No.
1 of this order and the amount of reactive
protein, measured generally acceptable
methods, must be less than 1% of the
containing nitrogen present in the diet.
The label must indicate that the product must not be
consumed by infants who are allergic to
intact proteins from which the product is
made if generally accepted clinical
tests show no evidence for this initial
baby food tolerance for over 90% of the
infants with known hypersensitivity to proteins, from the
which the hydrolysate is manufactured (interval
reliability of 95%).
Orally administered infant formulae
not in animals cause hypersensitivity to
intact proteins from which the initial
infant food made.
------------------------------------------- ------------------------------------------------
' Annex # 5 to # 54/2004 Sb.
Reference values for vitamins and minerals for nutritional labelling
the values of the
Table No. 1
Processed cereal-based foods for infants and young children
-------------------------------------------------------
Vitamin/mineral unit Reference
the substance the value for
labelling
-------------------------------------------------------
Vitamin A mikrog 400
Vitamin D mikrog 10
Vitamin C mg 25
thiamin mg 0.5
Riboflavin mg 0.8
niacin equivalents, mg 9
Vitamin B6 mg 0.7
Folic acid 100 mikrog
Vitamin B12 mikrog 0.7
Calcium mg 400
Iron mg 6
Zinc mg 4
iodine mikrog 70
Selenium mikrog 10
copper mg 0.4
-------------------------------------------------------
Table 2: Initial and follow-on formulae
-------------------------------------------------------
Vitamin/mineral unit Reference
the substance the value for
labelling
-------------------------------------------------------
Vitamin A mikrog 400
Vitamin D mikrog 7
Vitamin E mg TE *) 5
Vitamin K mikrog 12
Vitamin C 45 mg
Thiamin mg 0.5
Riboflavin mg 0.7
Niacin mg 7
Vitamin B6 mg 0.7
Folic acid mikrog 125
Vitamin B12 mikrog 0.8
Acid mg 3
Pantothenic acid
Biotin mikrog 10
Calcium mg 550
Phosphorus mg 550
Potassium mg 1000
Sodium 400 mg
Chloride mg 500
Iron mg 8
Zinc mg 5
iodine mikrog 80
Selenium 20 mikrog
Copper 0.5 mg
Magnesium mg 80
Manganese mg 1.2
-------------------------------------------------------
*) tokoferolekvivalent
' Annex No 6 to Decree No 54/2004 Sb.
Content of amino acids in breast milk
Table No. 1
Content of the essential and conditionally essential amino acids in the
breast milk (expressed in mg/100 kJ and in mg/100 kcal)
-----------------------------------------------
amino acid At 100 kJ *) on 100 kcal *)
-----------------------------------------------
Cystine 9 38
L-Histidine 10 40
Isoleucine 22 90
Leucine 40 166
Lysine 27 113
Methionine 5 23
Phenylalanine 20 83
Threonine 18 77
Tryptophan 8 32
Tyrosine 18 76
Valine 21 88
-----------------------------------------------
* 1 kJ = 0.239) kcal
Table No. 2
Content of amino acids in the reference protein casein
---------------------------------------
amino acid Quantity
g/100 g
protein
---------------------------------------
arginine 3.7
Cystine 0.3
L-Histidine 2.9
Isoleucine 5.4
Leucine 9.5
Lysine 8.1
Methionine 2.8
Phenylalanine 5.2
Threonine 4.7
Tryptophan 1.6
Tyrosine 5.8
Valine 6.7 "
---------------------------------------
30. In annex 7 of the table in section 3. The words "fats-linoleic acid
(in the form of glycerides) shall be not less than 0.007 g/100 kJ (0.3 g/100 kcal) and the
a maximum of 0.285 g/100 kJ (1.2 g/100 kcal) ' shall be replaced by "-acid
Linoleic (in the form of glycerides) shall be not less than 0.07 g/100 kJ (0.3 g/100
kcal) and a maximum of 0.285 g/100 kJ (1.2 g/100 kcal).
31. in annex 7 of the table in section 5. Vitamins vitamin D entry reads as follows:
+-------------------------------------------------------------------------+
|" Vitamin D3) (B) 0.25 mikrog (1 mikrog) 0.75 mikrog (3 mikrog) "|
+-------------------------------------------------------------------------+
32. In Annex 9, part 2. Amino acids for entry "L-isoleucine and
his hydrochloridy "inserted" L-Leucine and its hydrochloridy ".
33. In the heading of annex 1, the words "Potravnmikrogdoplňky"
nahrazujmikrogslovy "Vitamins, minerals and dalšmikroglátky" and in the
Note *) in the table, the words "31. December 2006 "shall be replaced by
"31 December 2009".
34. Annex 14 is added:
"Annex 14 of the Decree No 54/2004 Sb.
Specification of contents and protein sources and processing of protein used
in the manufacture of infant formulae, of a protein content less than 0.56
g/100 kj (2.25 g/100 kcal) manufactured from hydrolyzed whey
protein derived from cows ' milk proteins
--------------------------------------------------------------------
The Criterion Of Minimum Maximum Note
--------------------------------------------------------------------
1. content of 0.44 0.7 g/100 Content
proteins g/100 kJ kJ (3 protein =
(1.86 g/100 content
g/100 kcal) nitrogen x
kcal) 6.25
--------------------------------------------------------------------
2. Source of protein
Demineralised sweet whey protein derived
from cows ' milk after enzymatic precipitation of caseins using
chymozinu, consisting of the following substances:
and 63%) isolates whey proteins without casein
of glycomacropeptides with minimal protein content in the dry matter
95% and less than 70% of the denaturing of protein and ash content
not more than 3% and
b) 37% sweet whey protein concentrate with a minimum of
protein content in the dry matter 87% and denaturation of less than 70%
protein and ash content not more than 3.5%.
--------------------------------------------------------------------
3. protein Processing
Two-stage hydrolysis process using a trypsin preparation of,
and between these two the degree of hydrolysis occurs to the heat
treatment (3-10 minutes at 80 to 100 ° c). ".
35. in annex No. 16 table 2 item vitamin D is added:
+--------------------------------------------------+
|" Manganese (mikrog) 0.25 25 1 100 "|
+--------------------------------------------------+
Article. (II)
Transitional provisions
1. Food produced or labelled before the date of nabytmikrogúčinnosti
This order, which is not in accordance with section 4, section 5, in terms of section
5 (3). 1 to 5, paragraphs 6, 21 and 22 and with paragraph 29, as regards Annex No 1,
they may be put into circulation until 31 December 2004. December 2009.
2. Food for zvláštnmikroglékařské purposes intended for infants, which
neodpovídajmikrogpožadavkům laid down in point 5, in terms of § 5 para. 4
(a). a), b), (d)), and (e)), and in section 29, as regards Annex No 1 points 2.1.1.
and 2.2.1 and annex 2 section 2, can be put into circulation until 1. January
2012.
Article. (III)
The effectiveness of the
This Decree shall take effect on the date of 15. May 22, 2008.
Minister:
Mudr. Julínek, MBA in r.
