Foodstuffs Intended For Particular Nutritional Uses And How To Use Them

Original Language Title: potraviny určené pro zvláštní výživu a způsob jejich použití

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Read the untranslated law here: https://portal.gov.cz/app/zakony/download?idBiblio=57401&nr=54~2F2004~20Sb.&ft=txt

54/2004 Coll.
DECREE


Dated 30 January 2004

On foodstuffs intended for particular nutritional uses and how we use

Change: 402/2006 Coll.

Change: 473/2006 Coll.

Change: 157/2008 Coll.

Change: 35/2012 Coll.

Change: 46/2014 Coll.

Ministry of Health determined in accordance with § 19 para. 1 point. a) i)
Act no. 110/1997 Coll., on foodstuffs and tobacco products and amending and supplementing certain
related laws, as amended by Act no. 306/2000 Coll
. and Act no. 274/2003 Coll., (hereinafter the "Act")
PART 1

GENERAL PROVISIONS


§ 1

(1) This Decree implements the relevant regulations of the European Union ^ 1) and
adjusts further to the directly applicable regulations of the European Union ^ 1)
kinds of foods for particular nutritional requirements of the Health
foodstuffs for special nutrition, their composition, labeling and
conditions and how to use them.

(2) food intended for special nutrition for the purposes of this Decree
means foodstuffs intended for nutritional purposes specified in this Decree
and are marketed with the designation purpose.

(3) When determining nutritional purposes in accordance with paragraph 1, the special nutritional requirements


A) certain categories of persons whose digestive processes or metabolism is disturbed
,

B) certain categories of persons located in a particular physiological
condition and who are therefore able to benefit from specific
controlled consumption of certain substances in foods, or

C) healthy infants and young children.

(4) Vitamins, minerals and other substances with a nutritional or physiological effect
edited directly applicable regulation
European Union on vitamins, minerals and other substances-1c) (hereinafter
"Vitamins, minerals and other substances "), which may be added
to foodstuffs intended for particular nutritional uses, except
initial and follow-on formulas, processed cereal-based foods for infants and young children
are listed in the right applicable legislation of the European Union on
substances that may be added to foods for particular nutritional uses ^ 7)

§ 2

For the purposes of this Decree distinguishes between the following categories of foods for particular nutritional uses
:

A) foods for initial and follow-on formulas and nutritional
small children

B) food for grain and other nutrition other than cereal
intended for infants and young children

C) food for energy-restricted diets designed to reduce body weight
,

D) food for special medical purposes,

E) food without phenylalanine

F) foods low in lactose or lactose-free,

G) food intended for sportsmen and people at increased physical performance
.

§ 3

Labeling of foods for particular nutritional uses

(1) In addition to the data referred to in § 6 of the Act on the packaging of foodstuffs intended for particular nutritional uses
shall include information on

A) the specific qualitative and quantitative composition or the special manufacturing process
where they supply the product
special nutritional properties

B) the available energy value expressed in kJ and kcal, and the content
carbohydrates, protein and fat per 100 g or 100 ml of the product referred to
circulation and, where appropriate, in a specific amount of product || | offered for consumption. However, if the energy value is less than 50
kJ (12 kcal) per 100 g or 100 ml of the product put into circulation may be data
replaced either by the words "energy value less than 50 kilojoules (12 || | kilocalories) per 100 g "or the words" energy value less than 50 kJ (12 kcal
) in 100 g or 100 ml ", unless otherwise indicated,

C) the method of preparation (instructions) when the food before consumption
treatment requires a warning on the need to observe this instruction

D) origin proteins (plant, animal or particular source)
hydrolyzate or protein in the product, if the protein on the label
listed as an ingredient

E) the method of storage and time consumption after opening the packaging consumer
if required by the type of food and when the food is intended to gradually
consumption

F) category or detailed specifications foodstuffs intended for particular nutritional
.

(2) The name under which the product is sold, it should be noted
indication of its particular nutritional characteristics. In the case of foods specified in § 2

Point. a), b) or d) may be the indication to replace the data referring
intended use.

(3) Foods for particular nutritional uses not on the package label

A) information products ascribing properties
related to the prevention, treatment or cure of human disease or imply such properties
. Do not interfere with food for special medical purposes
marketing information or recommendations intended solely
persons qualified in medicine, nutrition or pharmacy

B) the information that their use does not need doctor's advice

C) the words "diet" or "dietetic" alone or in conjunction with other words
unless expressed purpose of their use,

D) the word "dia".
PART 2


Food for infant diet and nutrition SMALL CHILDREN


§ 4

(1) For the purposes of this Order shall mean

A) infants, children completed the twelfth month of age,

B) young children children over one year to complete the third year of age
,

C) infant formulas foodstuffs intended for particular nutritional
infants from birth to six months of age, infants, which correspond
nutritional requirements of this group of infants,

D) infant formula foods for particular nutritional
infants over six months, constituting the principal liquid share
progressively diversified diet of infants.

(2) The specific kinds of formulas are

A) start-up milk for premature babies and babies with low birth weight
,

B) lactic acid hydrolysed protein formula, designed to feed infants and young children
with milk allergy or allergic disease prevention
, which includes in particular the preparations

First with a high degree of hydrolysis of proteins,

Second with a low degree of hydrolysis of proteins,

C) specialty products, such as milk low in lactose, milk
antirefluxová, preparations for enriching human milk for children
low weight groups, nutritional products based on amino acids for
infant

D) nutrition based on soy.

§ 5

Requirements for the composition of foodstuffs for infant formulas and follow
diet and nutrition of young children

(1) Infant formulas manufactured from protein sources mentioned in Section 2
Annex no. 1 hereto and also of other components whose
suitability for particular nutritional use of infants has been established by generally accepted
scientific knowledge.

(2) Follow-on formulas manufactured from protein sources
mentioned in point 2 of Annex no. 2 hereto and also of other components whose
suitability for particular nutritional use by infants aged over six months has been
established by generally accepted scientific evidence.

(3) The composition of infant formulas and follow-on formulas
must be such as to prepare, requiring only the addition of water suitable for infants
^ 1d).

(4) Requirements

A) the composition of infant formulas are set forth in Annex no. 1
to this Decree with respect to the specifications given in Table. 1
Annex no. 6 to this Decree or in Annex no. 14 hereto,

B) the composition of infant formula are set forth in Annex no. 2 to
hereto with respect to the specifications given in Table. 1
Annex no. 6 hereto,

C) the use of vitamins, minerals and other substances are regulated
Annex no. 3 hereto,

D) the content of essential and conditionally essential amino acids in breast milk
are set forth in Table no. 1 in the Annex no. 6 hereto,

E) the content, source and processing of protein for infant formulas
made from hydrolysed proteins are set forth in Annex no. 14 to
hereto.

(5) purity standards for substances listed in Annex no. 3 hereto
provides for separate legislation on health requirements for the identity and purity of additives
^ 1e).

(6) infant nutrition and nutrition of young children
not contain any substance in such quantity as to endanger the health of infants or young children
especially

A) shall only contain additives according to a special legal
regulation laying down the types and conditions for use of additives and

Excipients ^ 2)

B) must meet the microbiological requirements set
directly applicable EU regulation on microbiological criteria for foodstuffs
^ 3)

C) shall not contain residues of pesticides ^ 3a) in quantities exceeding
0.01 mg / kg of the product as proposed for consumption, or the renewal
according to the manufacturer's instructions for each individual pesticide, || |
D) for the production of infant food and nutrition for young children
not use agricultural products treated with pesticides
which are provided in Annex no. 11. According to the definition of an agricultural product
untreated these pesticides is considered to be a product in which

First the content of pesticide residues modified in the Table. 1 Annex no. 11
not exceed the limit of 0.003 mg / kg, which is considered to be the limit of quantification
when determining broadly acceptable
standardized testing methods,

Second the content of pesticide residues listed in Table no. 2 of Annex no. 11
not exceed the limit of 0.003 mg / kg, which is considered to be the limit of quantification
when determining broadly acceptable
standardized testing methods,

E) must be complied with specific maximum residue levels of pesticides or metabolites of pesticides
initial and baby food and food for
small children that are listed in the Annex. 12 hereto.

(7) The content of pesticides and specific maximum limits specified in paragraph 6
point. d) and e) apply to foods which are intended to
consumption or prepared for use according to the manufacturer's instructions.

§ 6

Food labeling for initial and follow-on formulas and nutrition of young children


(1) The name of the food for the initial or follow-on formulas
must bear the words

A) the "initial milk formula", if jde- about infant nutrition
manufactured exclusively from cow's or goat's milk

B) "follow-on milk formula", if it is a
follow-on formulas made exclusively from cow's or goat's milk
,

C) "infant formula", in the case of other infant nutrition
,

D) "follow-on formulas", in the case of other
follow-on formulas.

(2) Apart from the data given in the Act and in § 3 of the packaging for the food
initial and follow-on formulas shall

A) for infant formulas, information that a food is suitable for
infants from birth, if they can not be breastfed,

B) for follow-on formulas information that a food is suitable
only for infants over six months old, as well as information that would
food should form only part of a diversified diet and should not be used as a substitute
breast milk during the first six months of life, and that
decision on the initiation of complementary feeding, including any exception from the rule
age of six months should be taken only on the basis
advice of a doctor or a person qualified in nutrition, pharmacy
or care for mother and child, depending on the individual growth and developmental needs of the particular
infant

C) for initial and follow-on formulas
available energy value expressed in kJ and kcal, and the content of proteins, fats and carbohydrates
in 100 ml of foodstuffs prepared for use as instructed by the manufacturer
, || |
D) for infant nutrition
numerically expressed average value for the content of individual vitamins and minerals by
annexes Nos. 1 and 2 and, where appropriate, the average value of the content of choline,
inositol, carnitine and taurine in 100 ml of foodstuffs prepared for use
according to manufacturer's instructions

E) for initial and follow-on formulas, instructions for appropriate
preparation, storage and handling of the product and warnings
importance of proper preparation and storage for infant health.

(3) In the case of infant nutrition label may indicate
numerical data on the average quantity of nutrients in 100 ml of foodstuffs prepared for use
according to the manufacturer's instructions, which are given in Annex no. 3, if you already
this information is given pursuant to paragraph 2. d).

(4) For infant formula may designation in addition to the figures
amounts of vitamins and minerals also contain statements

Percentage of the reference values ​​in Table no. 2 of Annex no. 5
100 ml of the product ready for use according to the manufacturer's instructions.

(5) food packaging for infant formulas include only
nutrition and health claims related to food ingredients
listed in Annex no. 4 to this Decree under the conditions specified therein.
Conditions for a nutrition or health claims for follow-on formulas
diet and nutrition for young children provides a directly applicable regulation
European Union on nutrition and health claims made on foods ^ 4).

(6) Part of the label infant formulas notice that
shall contain the words "Important Notice" or words having the same meaning and adding text expressing


A) the priority of breastfeeding before the infant food products,

B) a recommendation that the product be used only under a doctor's recommendation
or persons qualified in the field of nutrition, pharmacy or care for mother and child
.

(7) The packaging of foodstuffs for infant formulas should not be placed
pictures of infants or other pictures or claims that glamorized
product; acknowledges, however, graphic representations for the proper identification
engine illustration of the method of preparation.

(8) The packaging of foodstuffs for infant formulas and follow-on formulas
not be given the terms "humanised"
"maternalized", "modified" or similar terms.

(9) of foods for infant formulas and follow-on formulas
must be done comprehensively so as to exclude the risk of confusion
infant nutrition.

(10) The labeling of infant formulas and follow-on formulas
nutrition must be designed so as to provide the necessary information
appropriate use of the product, and such information should not discourage breastfeeding
.
PART 3


Cereal FOOD FOR NUTRITION AND OTHER DIETS other than cereal,
intended for infants and young children

§ 7

(1) food for cereal nutrition for infants and young children (hereinafter
'cereal-based foods ") are:

A) simple cereal products, in particular cereal slurry to be prepared
addition of milk or other suitable liquid by the manufacturer,

B) cereal products with added food rich in protein, particularly
obilnomléčné slurry prepared by adding water or other suitable liquid
recommended by the manufacturer, protein-free

C) pastas which are eaten after cooking in boiling water or another suitable liquid
recommended by the manufacturer

D) rusks and biscuits which are eaten either directly or after dilution and
mixed with water, milk or another suitable liquid
recommended by the manufacturer.

(2) food for other nutrition other than cereal
intended for infants and young children (hereinafter referred to as "foods") are non-milk foods
type of fruit, vegetables or meat, with the possible addition || | sugar is broken down into

A) fruit-based foods (food, snack, sauce, dessert)

B) foods, fruit with yogurt, cottage cheese, milk or other suitable
zakysaným product

C) ovocnoobilné foods,

D) ovocnozeleninové foods,

E) vegetable-based foods and soups,

F) masozeleninové foods and soups

G) meat-based foods

H) drinks to fruit, vegetable or on the basis of their mixtures
a fruit or vegetable concentrates.

(3) Food for grain and other nutrition other than cereal
intended for infants and young children not include milk intended for young children.

(4), cereal-based foods intended for infants and healthy nutrition
healthy young children or for feeding young children who are
converted to a mixed diet.

§ 8

Requirements for the composition of cereal and other foods

(1) cereal-based foods are produced

A) raw materials, whose suitability for particular nutritional use of infants and young children has been established
generally accepted scientific evidence,

B) using vitamins, minerals and other substances listed in Annexes
Nos. 7 to # 10.

(2) Requirements for basic composition of cereal and other foods
are given in Annexes Nos. 7 and # 8.

(3), cereal-based foods for infants and young children may not contain

Any substance in such quantity as to endanger the health of infants and young children
so:

) Must contain only those additives specified in a decree, which
down the types and conditions of use of additives and extraction solvents
food production ^ 2)

B) must meet the microbiological requirements set
directly applicable EU regulation on microbiological criteria for foodstuffs
^ 3)

C) shall not contain residues of individual pesticides at levels exceeding
0.01 mg / kg of the product (applicable to the product as
offered for consumption on or after restoration according to manufacturer instructions)

D) shall not be used for the production of processed cereal-based foods for infants and young children
in or on agricultural products and pesticides listed in Annex
no. 11. At the same time the following conditions:

First if the content of pesticide residues listed in Table no. 1 in the Annex no. 11
not exceed the limit of 0.003 mg / kg, which is considered to be the limit of quantification
when determining broadly acceptable
standardized methods, products not considered those treated with pesticides .
This limit will be reviewed regularly in line with technological progress,

Second if the content of pesticide residues listed in Table no. 2 of Annex no. 11
not exceed the limit of 0.003 mg / kg, will not be considered for these products
treated with pesticides. This limit will be reviewed regularly on the basis
data on the environmental pollution,

E) specific maximum residue levels of pesticides or metabolites of pesticides
for initial and follow-on formulas and processed cereal-based foods
are listed in Annex 12.

(4) The limits set out in paragraph 3. d) and e) apply to
foods intended for consumption or prepared according to manufacturer instructions
for consumption.

§ 9

Labelling cereal and other foods

(1) In addition to the data referred to in § 6 and § 3 of the packaging cereal and other foods shall


A) indicate the age of the infant or small child who is determined dish.
The age of the infant must not be lower than any product
finished fourth month; Products recommended since completed four months
may indicate that they are suitable from that age unless independent persons
qualifications in medicine, nutrition or pharmacy unless otherwise

B) whether food contains gluten, if it is marked for age
use food less six months

C) the available energy value expressed in kJ and kcal per 100 g or 100 ml
product and numerically expressed content of proteins, fats and carbohydrates in
100 g or 100 ml of the food as sold, or where it
appropriate, after preparation for use according to manufacturer's instructions

D) the average value of vitamin and mineral content
substances under Annex no. 7 and no. 8 in 100 g or 100 ml of the food as
is sold, or, where appropriate, after preparation for use according
manufacturer's instructions.

(2) The packaging of processed cereal-based foods could be given only

A) the average quantity of vitamins, minerals and other substances
listed in Annex no. 9 in 100 g or 100 ml of the food
as sold and, where appropriate, specified quantity
food ready for use according to the manufacturer's instructions, unless such declaration is not covered by paragraph 1
point. d)

B) numerical data on vitamins and minerals listed in the table
no. Annex 1 no. 5, expressed as a percentage specified therein
reference values ​​per 100 g or 100 ml of the food as sold, and
if appropriate, specified quantity of foodstuffs prepared for use as directed
producer, if the quantities present
represents at least 15% of the reference values,

C) nutrition or health claim under the conditions set
directly applicable EU regulation on nutrition and health
claims made on foods ^ 4).
PART 4 ​​


FOODS FOR ENERGY DIETS FOR THE REDUCTION OF BODY WEIGHT


§ 10

Food for energy-restricted diets designed to reduce body weight
(hereinafter referred to as "food for slimmers') are
foods are specially formulated which, when used according to manufacturer's instructions represent

A) full compensation for the daily diet

B) replacement of one or more main dishes daily diet.


§ 11

Requirements for the composition of food for slimmers

(1) Requirements for the composition of food for slimmers are listed in Annex
no. 15.

(2) All individual components of food for slimmers, which in combination
make full compensation for the daily diet
must be contained in a single joint package.

(3) Vitamins, minerals and other substances that may be added to food for
slimmers, provides a directly applicable regulation
European Union on substances that may be added to foods for special
nutrition ^ 7).

§ 12

Food labeling for slimmers

(1) Food for slimmers must be labeled

A) in the case of foods specified in § 10 paragraph. 1 point. a) the words "replacement
daily diet for weight reduction,"

B) in the case of foods specified in § 10 paragraph. 1 point. b) information whether
is the replacement of one or more main meals for weight reduction.

(2) In addition to the data referred to in § 6 and § 3 of the packaging for the food
slimmers give particulars

A) energy value expressed in kJ and kcal, and the content of proteins, carbohydrates and fats
per 100 g or 100 ml of foodstuffs prepared for use
according to manufacturer's instructions or the amount of food that replaces
one dish

B) of the average number of individual vitamins and minerals for
requirements laid down in Annex no. 15 hereto, at 100
g or 100 ml of foods intended for use according to the manufacturer's instructions, or
amount of food, which replaces a meal. For food
provided for in § 10 paragraph. 1 point. b) to further indicate the percentage of data
vitamins and minerals and their recommended daily doses
^ 5)

C) under a) and b) may also be expressed per portion, if
listed serving size and number of servings per container.

(3) The packaging of food for slimmers should be reminded

A) "may evoke a laxative effects" if they use
food according to the manufacturer's instructions leads to income
polyhydric alcohols (polyols) in the amount of more than 20 grams per day

B) the need to ensure an adequate daily fluid intake

C) that the food provides all essential nutrients in adequate quantity
per day for food referred to in § 10 paragraph. 1 point. a)

D) that the food should not be used without consulting a doctor for more than three weeks
for foodstuffs listed in § 10 paragraph. 1 point. a)

E) that the food complies with the intended use only as part
energy-restricted diet for foods listed in § 10 paragraph. 1 point. b)

F) an essential part of diet, consumers should be well known dishes and food and


G) that they are intended for persons 18 years and older.

(4) The labeling of foods for reducing diet must contain an indication of
rate or amount of weight loss due to its use.
PART 5


Dietary foods for special medical purposes

§ 13

(1) This section specifies requirements for the composition and labeling of dietary
foods for special medical purposes. For the purposes of this Decree
mean dietary foods for special medical purposes food
specially manufactured or composed, which are intended for special diet
patients and should be administered under medical supervision or on the basis of recommendations of a qualified
in the field of human nutrition, pharmacy or
care for mother and child. They are intended for full or partial nutrition
patients with a limited, impaired or disturbed capacity to enjoy, spend,
absorb, metabolize or excrete ordinary food,
certain nutrients contained in these foods or their metabolites
or nourishment for the persons with altered nutritional requirements to such an extent that their
nutrition management can not be achieved by modifying the normal diet, using
other foods for particular nutritional uses or combinations thereof.

(2) dietary foods for special medical purposes are

A) nutritionally complete foods with a standard formulation of nutrients that
may be the sole source of nutrition, ^ 6) when used as directed
manufacturer

B) nutritionally complete foods with a nutrient composition
specifically adapted for the disease, disorder or medical situation that
may be the sole source of nutrition ^ 6), provided that they are used according to the manufacturer's instructions
,


C) nutritionally incomplete foods with a defined composition of nutrients or
composition adapted specifically for the disease, disorder or medical
situation, which is not suitable as the sole source of nutrition. ^ 6)

(3) Foodstuffs listed in paragraph 2. b) and c) they can also be used to replace part
diet or as a supplement to enrich the diet of people
for which they are intended.

§ 14

Requirements for the composition of dietary foods for special medical purposes

(1) The formulation of dietary foods for special medical purposes must
consistent with good medical and nutritional principles and their application
according to the manufacturer's instructions must be safe and must be beneficial and effective in meeting
special dietary needs of people for which
determined, in accordance with generally accepted scientific evidence.

(2) requirements for the composition of dietary foods for special medical purposes
are listed in Annex 16.

(3) Vitamins, minerals and other substances that may be added to
dietary foods for special medical purposes, provides
directly applicable legislation of the European Union on substances that may be added to
foods for particular nutritional ^ 7).

§ 15

The labeling of dietary foods for special medical purposes

(1) The name of dietary foods for special medical purposes
must be labeled as "dietary food for special medical purposes" or
'food for special medical purposes ".

(2) In addition to the data referred to in § 6 and § 3 of the packaging
dietary foods for special medical purposes, the data:

A) energy value expressed in kJ and kcal, and the content of proteins, carbohydrates and fats
100 g or 100 ml of the food as sold,
and where appropriate per 100 g or 100 ml of foodstuffs prepared for use
according to manufacturer's instructions. This information may be reported for a dose
as indicated on the label, or for the portion provided that will
packaging the number of portions of the package or on the average amount of each
minerals and vitamins Annex no. 16 of table. 2 100 g
or 100 ml of the food as it is sold and, where appropriate, to
100 g or 100 ml of foodstuffs prepared for use according to manufacturer's instructions.
Such information may be reported for a dose, as indicated on the label
or serving, provided that the packaging contains the number of portions of the package
,

B) osmolality (number of moles of osmotically active particles
dissolved in 1 liter of water) or the osmolarity, where appropriate,

C) information on the origin and nature of the protein or protein hydrolysates
contained in the product.

(3) Packaging dietary foods for special medical purposes should be
label "Important" or equivalent expressing a warning that


A) the food must be used by the doctor or qualified person
in human nutrition, pharmacy or care for mother and child,

B) the food is or is not suitable as a sole source of nutrition,

C) the food is intended for a specific age group if
needed

D) the use of food can lead to threats to health when used
persons who do not have a disease, disorder or medical condition for which it is intended
food. This applies only in the event that such health threats
applicable.

(4) The packaging of dietary foods for special medical purposes should be given further


A) the words' Dietary foods when..... "Or" intended for the dietary management during
.... "With naming the disease, disorder or
medical condition for which the food is intended,

B) a description of features and characteristics that make use of the food
effective especially with regard to nutrient content that is raised, lowered,
eliminated or otherwise modified and the justifications for the use of food

C) with regard to their nature and method of use special data
necessary prevention and contraindications associated with using food

D) with regard to their nature and method of use warning that
food is intended for parenteral use,

E) with respect to the nature and method of use guidelines for the appropriate
method of preparation, consumption and storage of the product after the package was opened
.
PART 6


FOOD without phenylalanine

§ 16

(1) Foodstuffs without phenylalanine means food produced

Special technological procedure so that the content of phenylalanine
not exceed 20 mg per 100 g or 100 ml of foodstuffs in the state intended for consumption
. For food made from raw materials that are naturally free
phenylalanine must be a zero content.

(2) Foodstuffs without phenylalanine are intended for people with congenital, genetic
error of metabolism of phenylalanine.

§ 17

Food Labelling without phenylalanine

Besides the information specified in § 6 and § 3 of the container without food
phenylalanine give particulars

A) energy value in kJ and kcal. If the energy value
food in the state in which it is marketed, less than 50 kilojoules (12
kcal) per 100 g or 100 ml of the food, the statement on the energy value
to replace the words " energy value less than 50 kilojoules (12 kilocalories) per 100 g
or 100 ml "

B) the content of vitamins, minerals and other substances in the weight
units mcg, mg or g per 100 g or 100 ml of foodstuffs, or
other appropriate amounts corresponding to a daily dose of ^ 5) | ||
C) of the phenylalanine content in mg per 100 g or 100 ml of the food

D) foodstuffs must be used by the doctor or qualified person
in the field of medical and clinical nutrition, pharmacy or
care for mother and child,

E) a description of features and characteristics that make use of the food
effective especially with regard to nutrient content that is raised, lowered,
eliminated or otherwise modified and the justifications for the use of food

F) with respect to the nature and method of use of the necessary prevention and
contraindications associated with using food

G) with regard to their nature and method of use of a communication method
use this food

H) with regard to their nature and method of use guidelines for the appropriate
method of preparation, consumption and storage of the product after the package was opened
.
PART 7



Canceled
§ 18


Canceled
§ 19


Canceled PART 8



Canceled
§ 20


Canceled
§ 21


Canceled SECTION 9


Foods low in lactose or lactose free

§ 22

(1) For the purposes of this Order shall mean

A) foods with low lactose foods containing less than 1
g of lactose per 100 g or 100 ml of foodstuffs in the state intended for consumption

B) food bezlaktózovými foods containing less than 10 mg
lactose per 100 g or 100 ml of foodstuffs in the state intended for consumption and
in which the presence of free galactose excluded.

(2) Foods with a low-lactose or lactose-free
are designed for people with impaired metabolic transformation, food allergies or intolerances
and impaired organ function.

§ 23

Labeling of foods with low lactose or lactose-free

Besides the information specified in § 6 and § 3 of the food packaging
low-lactose or lactose-free data indicate

A) energy value in kJ and kcal. If the energy value
food in the state in which it is marketed, less than 50 kilojoules (12
kcal) per 100 g or 100 ml of the food, the statement on the energy value
to replace the words " energy value less than 50 kilojoules (12 kilocalories) per 100 g
or 100 ml "

B) the content of vitamins, minerals and other substances in the weight
units mcg, mg or g per 100 g or 100 ml of foodstuffs, or
other appropriate amounts corresponding to a daily dose of ^ 5) | ||
C) the content of lactose in g per 100 g or 100 ml of the food.
PART 10



Canceled
§ 24


Canceled
§ 25


Canceled PART 11



Canceled
§ 26


Canceled
§ 27


Canceled PART 12


Foods intended for athletes and people at increased physical performance

§ 28

For the purposes of this Decree food intended for sportsmen and
people at increased physical exercise mean

A) foods for greater energy supply, which is his special
composition, particularly the higher energy content of nutrients (carbohydrates, fats)
clearly distinct from foods for normal consumption and that contain nutrients
increasing use energy sources (e.g., vitamin B1,
carnitine, chromium and other materials having such effect)

B) foods stimulates the muscles, which in its composition, particularly
high protein, peptide, or essential amino acids are

Suitable for this purpose or that contain substances that help
this purpose,

C) other specific foods designed especially for sports nutrition,

D) drinks for athletes, especially isotonic drinks, which contain substances
enhancing physical performance, or drinks designed to replace
minerals, whose loss was due to increased body
(sports) performance, which are distinguished:

First isotonic drinks, whose osmolality is 290 + - 15 milliosmoles in 1
l drink prepared for consumption

Second hypertonic drinks, whose osmolality is 340 or more
milliosmoles in 1 l ready for consumption,

Third hypotonic drinks, whose osmolality is 250 or less milliosmoles
in 1 l ready for consumption,

Fourth other sports drinks.

§ 29

Requirements for the composition of food intended for sportsmen and people at increased physical performance


Vitamins, minerals and other substances that may be added to
food intended for sportsmen and people at increased physical performance
provides directly applicable EU regulation on substances that may be added
in foods for particular nutritional uses ^ 7).

§ 30

Labeling of food intended for sportsmen and people at increased physical performance


Besides the information specified in § 6 and § 3 of the packaging of food intended for sportsmen state


A) the words "suitable for athletes" or "suitable at increased physical performance
" as part of the name of the food

B) ionic beverages indication of osmolality in milliosmoles per 1 l
consumed after preparation according to the manufacturer's instructions,

C) for foods containing caffeine label "contains caffeine", "
not suitable for registered athletes,"

D) an indication of the content of vitamins, minerals and other substances in
weight units mcg, mg or g per 100 g or 100 ml
food, or other appropriate amounts corresponding to a daily dose of ^ 5)

E) an indication of the energy value in kJ and kcal. If the energy value
food in the state in which it is marketed, less than 50 kilojoules (12
kcal) per 100 g or 100 ml of the food, the statement on the energy value
to replace the words " energy value less than 50 kilojoules (12 kilocalories) per 100 g
or 100 ml. "

§ 31


Transitional provisions
Foods that have been made and will be put into circulation before
force of this Decree, shall be assessed in accordance with current legal regulations
.

§ 32
Repealing provisions


The Decree no. 23/2001 Coll., Laying down
kinds of foods for particular nutritional uses and how to use them.

§ 33
Efficiency


This Decree shall enter into force on 15 February 2004.
Minister
:

MD. Součková vr
Appendix 1


Basic composition of infant formulas prepared in accordance with the manufacturer's instructions


(Values ​​laid down in this Annex refer to the final product
ready for use, marketed as such or prepared
according to manufacturer's instructions)

----------------------------------------------- --------------------- ----------------------------- --------------------
Criterion Minimum Maximum Note -------------------------------------------
------------------------- ------------------------- ------------------------
first Energy 250 kJ / 100 ml 295 kJ / 100 ml (70 Vhodnostsložek to prove the systematic
(60 kcal / l00 kcal / 100 ml) review of the available data relating
ml), the expected benefits and safety considerations, and || | if necessary, also using
corresponding studies prepared
according to generally accepted professional
guidance on the form and manner of drafting
takovýchstudií.
Vhodnostdalších components intended for
zvláštnívýživu infants from birth to be
established by generally accepted scientific
knowledge.
----------------------------------------------- --------------------- ----------------------------- --------------------

Second Protein Protein content = nitrogen content x 6.25 -------------------------------------
------------------------------- ------------------- ------------------------------
2.1 infant 0.45 g / 100 kJ 0.7 g / 100 kJ for the same energy value must
food produced (1.8 g / 100 (3 g / 100 kcal) infant formulas contain every
proteins from cow or kcal) essential and conditionally essential amino acid
goat's milk for at least the same
available quantity of what is contained in
reference protein given in Annex no. 6
Table 1 below.
When calculating the concentrations of methionine
and cystine added together if the methionine ratio
Cystine is not greater than 2, it also
can be summed concentration of phenylalanine and
tyrosine, if the ratio of tyrosine to
phenylalanine does not exceed a value of 2. If
the suitability of the product for infant nutrition
demonstrated by appropriate studies
drawn up in accordance with generally
accepted expert guidance on the form
and the method of preparation of such studies may
the ratio of methionine to cystine greater than 2,
but must not exceed a value of 3.
----------------------------------------- --------------------------- ----------------------- -------------------------- 2.1.1 infant
0.45 / 100 kJ 0,5 g / 100 kJ (2, 0 For infant formulas made from
food made from protein (1.8 g / 100 g / 100 kcal) bílkovinkravského or goat's milk containing
cow's or goat's milk kcal) bílkovinv range between a minimum value
and 0.5 g / 100 kJ (2 g / 100 kcal), the suitability
infant formula for special
infants demonstrated by
corresponding studies prepared
according to generally accepted professional
guidance on the form and manner of drafting
takovýchstudií.
-------------------------------------------------- -------------------------------- ------------------ -----------------
2.2 infant 0.45 g / 100 0.7 g / 100 kJ (3 g / 100 kJ
food produced (1, 8 g / 100 kcal) For an equal energy value must
of hydrolysed protein kcal) infant formulas contain every
essential and conditionally essential
amino acid at least equally applicable
the amount of which is contained in the reference
protein (breast milk, as defined in Annex no. 6
Table. 1). In the calculation may
the concentration of methionine and cystine add up
if the ratio of methionine to cystine does not exceed
= 2, and so may be summed
the concentration of phenylalanine and tyrosine as
the ratio of tyrosine to phenylalanine does not exceed
2. If the value of the product's suitability for
infants demonstrated by appropriate
studiemivypracovanými in accordance with
generally accepted expert guidance
on the shape and the method of preparation
takovýchstudií, the ratio of methionine to
cystine greater than 2 but shall not exceed
value 3.
L-carnitine content shall be at least 0.3
mg / 100 kJ (1.2 mg / 100 kcal).

----------------------------------------------- --------------------- ----------------------------- -------------------- 2.2.1 infant
0.45 g / 100 0.56 g / 100 kJ (2.25 U of infant formulas manufactured
of food produced kJ (1.8 g / 100 g / 100 kcal) of hydrolysed protein with a protein content of hydrolysed protein
kcal) between the minimum value and 0.56
g / 100 kJ (2.25 g / 100 kcal), the suitability
infant formula for special
infants demonstrated by
corresponding studies prepared
according to generally accepted professional
guidance on the form and manner of drafting
takovýchstudií and must comply with
corresponding specifications in the
Annex no. 14 of this Decree.
----------------------------------------------- --------------------- ----------------------------- --------------------
2.3 infant 0.56 g / 100 kJ 0.7 g / 100 kJ (3 g / 100 In the manufacture of infant
eating food made from isolates of 2,25 g / 100 kcal) shall be used only protein isolates from soy.
Soy protein kcal) For an equal energy value the
alone or mixed with infant formula contain every
cow proteins essential and conditionally essential
or goat's milk amino acid at least equally applicable
the amount of which is contained in the reference
protein (breast milk, as defined in Annex no. 6
Table 1). In the calculation, however, can
the concentration of methionine and cystine add up
if the ratio of methionine to cystine does not exceed
= 2, and so may be summed
the concentration of phenylalanine and tyrosine as
the ratio of tyrosine to phenylalanine does not exceed
2. If the value of the product's suitability for
infants demonstrated by appropriate
studiemivypracovanými in accordance with
generally accepted expert guidance
on the shape and the method of preparation
takovýchstudií, the ratio of methionine to
cystine greater than 2 but shall not exceed
value 3.
L-carnitine content shall be at least 0.3
mg / 100 kJ (1.2 g / 100 kcal).
----------------------------------------------- --------------------- ----------------------------- --------------------
2.4 in all cases, amino acids may be to infant formulas added solely to improve
nutritional value of the proteins, and only in an amount necessary to this purpose.
----------------------------------------------- --------------------- ----------------------------- --------------------
third Taurine (added) 2.9 mg / 100 kJ (12
mg / 100 kcal)
-------------------------- ------------------------------------------ -------- -----------------------------------------
fourth Choline 1.7 mg / 100 kJ to 12 mg / 100 kJ
(7 mg / 100 kcal) (50 mg / 100 kcal)
--------------------------------- ----------------------------------- --------------- ----------------------------------
fifth Fats 1,05 g / 100 1.4 g / 100 kJ (6.0
kJ (4.4 g / 100 g / 100 kcal)
kcal)
-------- -------------------------------------------------- ---------- ---------------------------------------- ---------
5.1 It is forbidden to use these substances:
- Sesame oil,
- Cotton seed oil.
----------------------------------------------- --------------------- ----------------------------- --------------------
5.2 lauric - individually or together:
myristic 20% of the total fat content

----------------------------------------------- --------------------- ----------------------------- --------------------
5.3 The trans fatty acid content shall not exceed 3% of the total fat content.
----------------------------------------------- --------------------- ----------------------------- --------------------
5.4 erucic acid content shall not be greater than 1% of the total fat content.
----------------------------------------------- --------------------- ----------------------------- --------------------
5.5 linoleic acid (in 70 mg / 100 kJ 285 mg / 100 kJ (1200 mg / 100 kcal)
form of glycerides = (300 mg / 100
linoleates) kcal) ----------------------------------
---------------------------------- ---------------- ---------------------------------
5.6 Content of alpha-linolenic acid should be less than 12 mg / 100 kcal (50 mg / 100 kcal). The ratio of linoleic acid to
alpha-linolenic acid shall be at least 5 and most of the 15th
---------------------------- ---------------------------------------- ---------- ---------------------------------------
5.7 may be added polyunsaturated fatty acids long chain (20 and 22 carbon atoms). In this case
not their content in the total fat content greater than:
- 1% for n-3 polyunsaturated fatty acids, long chain
- 2% for n-6 polyunsaturated fatty acids with long chain
(1% for arachidonic acid (20: 4 n-6)).

Eicosapentaenoic acid (20: 5 n-3) shall not be greater than the content of docosahexaenoic acid (22: 6 n-3).

Content of docosahexaenoic acid (22: 6 n-3) shall not be greater than the content of n-6 polyunsaturated fatty acids with long-chain
.
----------------------------------------------- --------------------- ----------------------------- --------------------
6th Phospholipids 2 g / l
------------------------------------------ -------------------------- ------------------------ -------------------------
7th Inositol 1 mg / 100 kJ 10 mg / 100 kJ (40 mg / 100 kcal)
(4 mg / 100 kcal
)
------------------------------------- ------------------------------- ------------------- ------------------------------
8th Carbohydrates 2.2 g / 100 3.4 g / 100 kJ (14 g / 100 kcal) shall be used solely those
kJ (9 g / 100 Carbohydrates:
kcal) - lactose,
- Maltose,
- Sucrose,
- Glucose,
- Maltodextrins,
- Glucose syrup or dried
glucose syrup,
- Pre-cooked starch - naturally
gluten-free,
- Gelling starch - naturally
gluten-free.
----------------------------------------------- --------------------- ----------------------------- --------------------
8.1 Lactose 1.1 g / 100 - This provision does not apply to
kJ (4.5 g / 100 infant formulas in
kcal) which soya protein isolates
They represent more than 50% of
total protein content.
----------------------------------------------- --------------------- ----------------------------- --------------------
8.2 Sucrose (added) 20% of the total carbohydrate content Sucrose can only add
to infant formulas
made from hydrolysed
proteins.
----------------------------------------------- --------------------- ----------------------------- --------------------
8.3 Glucose (added) 0.5 g / 100 kJ (2 g / 100 kcal) Glucose can only add
to infant formulas
made from hydrolysed
proteins.
----------------------------------------------- --------------------- ----------------------------- --------------------
8.4 Pre-cooked and / or - 2 g / 100 ml and 30%
gelling starch of the total content
carbohydrates
---------------------------------------------- ---------------------- ---------------------------- ---------------------

9th Fructo-oligosaccharides and 0.8 g / 100 ml Other combinations and maximum
galactooligosaccharides combined 90% of fructooligosaccharides and
oligogalaktosyl- galactooligosaccharides can
lactose and 10% use it in accordance with § 5 para. 1
oligofruktosyl- hereof.
High sucrose
molecular weight
--------------------------------------------- ----------------------- --------------------------- ----------------------
10th Minerals
--------------------------------------------- ----------------------- --------------------------- ----------------------
10.1 infant formulas manufactured from protein per 100 kJ per 100 kcal
cow's or goat's milk or a hydrolysed proteins | || ------------------------------------------------ -------------------- ------------------------------ -------------------
minerals the units MinimumMaximum 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) 0.07 0.3 0.3 1.3
Zinc (mg) 0.12 0.36
0.5 1.5 Copper (mcg) 8.4 25 35 100
Iodine (mcg) 2.5 12 10 50
Selenium (mcg) 0.25 2.2 1 9
manganese (mcg) 0.25 25 1100
Fluoride (microg) - 25-100
-------------------------- ------------------------------------------ -------- -----------------------------------------
ratio of calcium to phosphorus should not be less than 1.0 or greater than 2.0.
----------------------------------------------- --------------------- ----------------------------- --------------------
10.2 infant formulas manufactured from soya protein isolates, samotnýchnebo mixed with protein
cow's or goat's milk
applies all the requirements of paragraph 10.1, with the exception of those concerning iron and phosphorus, which are as follows:
------------------------------- ------------------------------------- ------------- ------------------------------------
Iron (mg) 0.12 0.5 0 45 2
Phosphorus (mg) 7.5 25 30 100 -------------------------------
------------------------------------- ------------- ------------------------------------
11th Vitamins Per 100 kJ Per 100 kcal
---------------------------------------- ---------------------- ---------------------------- ---------------------------
Vitamin unit Minimum Maximum Minimum Maximum
----------- -------------------------------------------------- ------- ------------------------------------------- ------
Vitamin A (mcg RE) (*) 14 43 60 180
Vitamin D (mcg) (**) 0.25 0.65 1 2.5
Thiamin ( microg) 14 72 60 300
Riboflavin (mcg) 19 95 80 400
Niacin (mcg) (***) 72375300 1500
pantothenic acid (mcg) 95475400 2000
vitamin B6 (mcg) 9 42 35 175
Biotin (mcg) 0.4 1.8 1.5 7.5
folic acid (mcg) 12 2.5 10 50
vitamin B12 (mikikrog) 2.5 7.5 10 30
Vitamin K (mcg) 1 6 4 25
Vitamin E (mg alpha-TE) (****) 0.5 / g (*****) 1 2 0.5 / g (******) 5
------------------------------- ------------------------------------- ------------- ------------------------------------ TE) (****)
12th Nucleotides
---------------------------------------------- ---------------------- ---------------------------- ---------------------
Highest (*******)
(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, the 10 mcg = 400 IU of vitamin D
(***) A preformed niacin.
(****) Alpha-TE = d-alpha-tocopherol-equivalent
(*****) Of polyunsaturated fatty acids,
expressed as linoleic acid and adjusted according to the number of double
bonds ********), in any case no less than 0.1 mg / 100
usable kJ
(******) Polyunsaturated fatty acids,
expressed as linoleic acid and adjusted according
number of double bonds (********)
in any case no less than 0.5
mg / 100 kcal usable
(*******) Total concentration of nucleotides shall not
greater than 1.2 mg / 100 kJ (5 mg / 100 kcal)

(********) 0.5 mg alpha TE / 1 g of linoleic acid (18: 2 n-6)
0.75 mg alpha-TE / 1 g alpha-linolenic acid (18: 3 n-3)
1.0 mg alpha TE / 1 g of 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 of docosahexaenoic acid (22: 6 n-3)


Appendix 2


Basic composition of infant formula prepared in accordance with the manufacturer's instructions


(Values ​​laid down in this Annex refer to the final product
ready for use, marketed as such or prepared
according to manufacturer's instructions)

----------------------------------------------- --------------------------------------------- ----- ---------------------
Criterion Minimum Maximum Note -------------------------------------------
----------------------------------------- --------- -------------------------
first Energy 250 kJ / 100 ml 295 kJ / 100 ml suitability of ingredients shall be demonstrated by systematic review
(60 kcal / 100 (70 kcal / 100 available data relating to the expected benefits and considerations
ml) ml), security, and if necessary also by corresponding
studies prepared in accordance with generally accepted professional
guidance on the form and method of preparation of such studies.
The appropriateness of further ingredients intended for special infant nutrition from
birth shall be demonstrated by generally accepted scientific
knowledge.
----------------------------------------------- --------------------------------------------- ----- ---------------------
second Protein Protein content = nitrogen content x 6.25 -------------------------------------
--------------- ----------------------------------- ------------------------------- 2.1 Follow
0.45 g / 100 0.8 g / 100 for the same energy value the follow-on formula
food made from kJ (1.8 g / 100 kJ (3.5 contain every essential and conditionally essential amino acid protein
cow kcal) g / 100 kcal) at least equal to the amount of usable, what it is contained in
or goat's milk reference protein (breast milk, as defined in Annex no. 6
table no. 1 hereto). In the calculation, however, can
the concentration of methionine and cystine added together if the ratio of methionine
to cystine does not exceed 3, and so may be summed
the concentration of phenylalanine and tyrosine, when the tyrosine ratio
phenylalanine does not exceed a value of 2.
------------------------------------------ ---------- ---------------------------------------- -------------------------- 2.2 follow
0.45 g / 100 kJ 0.8 g / 100 For the same energy value must follow
nutrition food made from (1.80 g / 100 kJ (3.5 contain every essential and conditionally essential amino acid hydrolyzed
kcal) g / 100 kcal) of at least the same available quantity of what is contained in
protein reference protein (breast milk, as defined in Annex no. 6

Table no. 1 hereto). In the calculation, however, can
the concentration of methionine and cystine added together if the ratio of methionine
to cystine does not exceed 3, and so may be summed
the concentration of phenylalanine and tyrosine, when the tyrosine ratio
phenylalanine does not exceed a value of 2.
------------------------------------------ ---------- ---------------------------------------- -------------------------- 2.2.1 continuation
0.45 g / 100 kJ 0.56 g / 100 kJ For follow-on formulas formulas manufactured from hydrolyzed
food produced (1.8 g / 100 (2.25 g / 100 protein with a protein content ranging between a minimum value and
from hydrolysed kcal) kcal) 0.56 g / 100 kJ ( 2.25 g / 100Kcals) the appropriateness of continuing
protein infant formula for special infant nutrition proves
through appropriate studies produced in accordance with
generally accepted expert guidance on the form and manner
preparation of such studies and shall be in accordance with the relevant
specifications set out in Annex no. 14 hereto.
----------------------------------------------- --------------------------------------------- ----- --------------------- 2.3 Follow
0.56 g / 100 kJ 0.8 g / 100 in manufacturing these formulas sepoužívají only isolates of soy
food made from (2.25 g / 100 kJ (3.5 proteins.
soy isolates kcal) g / 100 kcal) For an equal energy value the follow-on formula
proteins, alone contain every essential and conditionally essential amino acid | || or in a mixture with at least the same available quantity of what is contained in cow proteins
reference protein (breast milk listed in Annex no. 6
or goat's milk table no. 1 hereto). In the calculation, however, can
the concentration of methionine and cystine added together if the ratio of methionine
to cystine does not exceed 3, and so may be summed
the concentration of phenylalanine and
tyrosine, if the ratio of tyrosine to phenylalanine does not exceed a value of 2.
------------------------------------ ---------------- ---------------------------------- --------------------------------
2.4 in all cases may be amino acids in infant formula added
only for improving the nutritional value of the proteins and in the necessary amount for this purpose.
----------------------------------------------- --------------------------------------------- ----- ---------------------
third Taurine (added) 2.9 mg / 100 kJ (12
mg / 100 kcal)
-------------------------- -------------------------- ------------------------ ------------------------------------------
fourth Fats 0.96 g / 100 1.4 g / 100
kJ (4.0 kJ (6.0
g / 100 kcal) g / 100 kcal)
------------------------ ---------------------- ---------------------------- --------------------------------------------
4.1 is prohibited the use of these substances:
- Sesame oil,
- Cotton seed oil.
----------------------------------------------- --------------------------------------------- ----- ---------------------
4.2 lauric acid - individually or together
acid: 20%
myristic the total content
Fat
---------------------------------------------- -------------------------------------------- ------ ----------------------
4.3 The trans fatty acids shall not be greater than 3% of the total fat content
.
----------------------------------------------- --------------------------------------------- -----
--------------------- 4.4 The erucic acid content shall not be greater than 1% of the total fat content.
----------------------------------------------- --------------------------------------------- ----- ---------------------
4.5 acid 70 mg / 100 285 mg / 100
Linoleic kcal (300 kJ (1200
(as mg / 100 kcal) mg / 100 kcal glycerides

=
linoleates) -----------
----------------------------------------- --------- -------------------------------------------------- -------
4.6 Content of alpha-linolenic acid should be at least 12 mg / 100 kJ (50 mg / 100 kcal).
ratio of linoleic acid to alpha-linolenic acid should be at least 5 and a maximum of 15 .

----------------------------------------------- --------------------------------------------- ----- ---------------------
4.7 may be added polyunsaturated fatty acids with long-chain (20
and 22 carbon atoms). In that case their content shall not
in the total fat content greater than:
- 1% for n-3 polyunsaturated fatty acids, long chain
- 2% for n-6 polyunsaturated fatty acids with long-chain
(1% for arachidonic acid (20: 4 n-6)).
Eicosapentaenoic acid (20: 5 n-3) shall not be greater than the content of docosahexaenoic acid (22: 6 n-3).

Content of docosahexaenoic acid (22: 6 n-3) shall not be greater than the content of n-6 polyunsaturated fatty acids
long chain.
----------------------------------------------- --------------------------------------------- ----- ---------------------
fifth Phospholipids 2 g / l
------------------------------------------ ---------- ---------------------------------------- --------------------------
6th Carbohydrates 2.2 g / 100 kJ 3.4 g / 100 kJ is forbidden to use ingredients
(9 g / 100 (14 g / 100 kcal) containing gluten.
Kcal)
--------------------------- ------------------------- ------------------------- -----------------------------------------
6.1 Lactose 1.1 g / 100 kJ - This provision does not apply to
4.5 g / 100 follow kojeneckouvýživu in
kcal which isolates sójovýchbílkovin
They represent more than 50% of
total protein content.
----------------------------------------------- --------------------------------------------- ----- ---------------------
6.2 Sucrose
fructose, honey - individually or copper must be treated so that
total: 20% destroy spores of Clostridium
the total content botulinum.
carbohydrates
---------------------------------------------- -------------------------------------------- ------ ----------------------
6.3 Glucose (added) 0.5 g / 100 kJ (2 Glucose can only add
g / 100 kcal) in infant formula
made from hydrolysed
proteins.
----------------------------------------------- --------------------------------------------- ----- ---------------------
7th Fructo-oligosaccharides and 0.8 g / 100 ml Other combinations and maximum
galactooligosaccharides combination of 90% of fructooligosaccharides and
oligogalaktosyl- galactooligosaccharides can
lactose and 10% use it in accordance with Article 5 Para. 2
oligofruktosyl- hereof.
High sucrose
molecular

weight ---------------------------------------------- -------------------------------------------- ------ ----------------------
8th Minerals
--------------------------------------------- ------- ------------------------------------------- -----------------------
8.1 Follow-on formulas made from cow proteins

or goat's milk or a hydrolysed protein
- -------------------------------------------------- - ------------------------------------------------- -----------------
100 kJ per 100 kcal
------------------ ---------------------
Minerals the units 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 (mcg) 8.4 25 35 100
Iodine (mcg) 2.5 12 10 50
Selenium (mcg) 0.25 2.2 1 9
Manganese (mcg) 0 25 25 1100
Fluoride (mcg) - 25-100

Ratio of calcium to phosphorus shall not be less than 1.0 or greater than 2.0.
----------------------------------------------- --------------------------------------------- ----- ---------------------

8.2 Follow-on formulas made from isolates of soy proteins, alone or mixed with
protein in cow's or goat's milk
All the requirements of paragraph 8.1, except for the requirements for iron and phosphorus, which are
- -------------------------------------------------- -----------------------------------------
Iron (mg) 0 22 0.65 0.9 2.5
Phosphorus (mg) 7.5 25 30 100
------------------------ ---------------------- ---------------------------- --------------------------------------------
9th Vitamins Per 100 kJ Per 100 kcal
---------------------------- ------------ -------------------------------------------------- -----------
Vitamin unit Minimum Maximum Minimum Maximum
--------------------------- - ------------------------------------------------- ------------------------
Vitamin A (microg-RE) (*) 14 4360 180
Vitamin D (mcg) (* *) 0.25 0.751 3
Thiamin (Mg) 14 7260 300
Riboflavin (mcg) 19 9580 400
Niacin (mcg) (***) 72 375300 1500
pantothenic acid (microg ) 95 475400 2000
Vitamin B6 (Mg) 9 4235 175
Biotin (MS) 0.4 7.5 1,81,5
Folate (Mg) 2.5 1210 50
vitamin B12 (mcg) 0.5 0.025 0,120,1
vitamin C (mg) 2.5 7510 30
vitamin K (mcg) 1 64 25
vitamin E (mg alpha-TE) (** *) * 0.5 / g (*****) 1,20,5 / g (******) 5
---------------- ------------------------------------ -------------- -------------------------------------------------- -
10th Highest 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, the 10 mcg = 400 IU of vitamin D
(***) A preformed niacin.
(****) Alpha-TE = d-alpha-tocopherol equivalents.
(*****) Of polyunsaturated fatty acids expressed as linoleic acid
and adjusted according to the number of double bonds (********)
in any case no less than 0.1 mg / 100 kJ usable.
(******) Of polyunsaturated fatty acids expressed as linoleic acid
and adjusted according to the number of double bonds (********)
in any case no less than 0.5 mg / 100 kcal usable.
(*******) The total concentration of nucleotides shall not be greater than 1.2 mg / 100kJ (5 mg / 100 kcal).
(********) 0.5 mg alpha TE / 1 g of linoleic acid (18: 2 n-6);
0.75 mg alpha-TE / 1 g alpha-linolenic acid (18: 3 n-3);
1.0 mg alpha TE / 1 g of 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 of docosahexaenoic acid (22: 6 n-3).
Appendix 3


Vitamins, minerals and other substances

Table. 1
Vitamins

------------------------- ------------------ ---------------------
vitamin Chemical name of vitamin
------------------- --------------------------------------- ------
Vitamin A retinyl
retinyl palmitate

retinol ------------------------- --------------------- ------------------
vitamin D vitamin D2 (ergocalciferol)
Vitamin D3 (cholecalciferol)
------------------------- ----------------- ----------------------
Vitamin B1 thiamine hydrochloride
thiamin mono nitrate
------------------------- ------------------- --------------------
Vitamin B2 riboflavin
riboflavin-5'-phosphate
------------------------- --------------- Niacin nicotinamide ------------------------

nicotinic acid
------------------------- -------------------- -------------------
Vitamin B6 pyridoxine hydrochloride
pyridoxine 5'-fosforečnan
------------------------- ---------------- -----------------------

Folic acid Folic acid
------------------------- --------------- ------------------------
pantothenic acid D-calcium pantothenate
D-pantothenate, sodium
dexpanthenol
------------------------- --------------------- ------------------
Vitamin B12 cyanocobalamin
hydroxykobalamin
------------------------- --------------------- ------------------
biotin D-biotin
---------------------- --------------------------------------- ---
Vitamin C L- ascorbic
L-sodium ascorbate
Calcium L-ascorbate
acid 6-palmityl-L-ascorbic
(Ascorbyl palmitate)
potassium ascorbate
------------------------- -------------------- -------------------
Vitamin E D-alpha tocopherol
DL-alpha-tocopherol
D-alpha-tocopheryl acetate
DL-alpha-tocopheryl
------------------------- ----------------- ----------------------
Vitamin K phylloquinone (phytomenadione)


------------------------- ---------------------- -----------------

Table. 2
Minerals


Minerals as authorized salts
------------------------- --------------- ------------------------
calcium (Ca) calcium carbonate
Calcium chloride
calcium citrate
calcium gluconate
glycerolfosforečnan calcium
Calcium lactate
calcium salts of orthophosphoric acid
Calcium hydroxide
------------------------- -------------------- -------------------
magnesium (Mg), magnesium carbonate
Magnesium chloride
magnesium oxide
magnesium salts of orthophosphoric acid
Magnesium sulphate
gluconate, magnesium
magnesium hydroxide
magnesium salts of citric acid
------------------------- ------------------ ---------------------
Iron (Fe) ferrous citrate
Ferrous gluconate
lactate ferrous
ferrous sulphate
citrate ferric ammonium
iron fumarate
ferric pyrophosphate
(Ferric pyrophosphate)
bisglycinate iron
------------------------- -------------------- -------------------
Copper (Cu) copper citrate
gluconate, copper
Copper sulphate
complex copper-lysine
copper carbonate
------------------------- -------------------- -------------------
Iodine (I) potassium iodide
sodium iodide
potassium iodate
------------------------- -------------------- -------------------
zinc (Zn) zinc acetate
Zinc chloride
Birch
zinc sulphate
Zinc citrate
Zinc gluconate
Zinc oxide
------------------------- -------------------- -------------------
Manganese (Mn) Manganese carbonate
manganese chloride
Manganese citrate
manganese sulfate
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 salt of citric acid
gluconate, potassium
potassium lactate
potassium salts of orthophosphoric acid
Potassium hydroxide
------------------------- -------------------- -------------------
Selenium (Se) sodium selenate
sodium selenite
------------------------- -------------------- -------------------
Table
.
3 ------------------------- --------------- -------------
Amino acids and other nitrogen compounds
------------------------- - ---------------------------
L-arginine hydrochloride, arginine, and only for the initial
infant formulas made from hydrolysed
protein and follow-on formulas manufactured

Of hydrolysed proteins with a protein content ranging
0.45 g / 100 kJ (1.80 g / 100 kcal) - 0.56 g / 100 kJ
(2.25 g / 100 kcal)

L-cystine and L-cystine hydrochloride
L-histidine and L-histidine hydrochloride
L-isoleucine and L-isoleucine hydrochloride
L-leucine hydrochloride and L-leucine, L-lysine
hydrochloride and L-lysine
L-cysteine ​​hydrochloride and L-cysteine, L-methionine


L-phenylalanine L-threonine L-tryptophan

L-tyrosine L
-valine
L-carnitine hydrochloride and of L-carnitine
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 no. 4
----------------------


Other nutritional substances ---------------- ------

choline chloride, choline citrate


choline bitartrate choline


inositol ------------ ----------

Appendix 4


Nutrition and health claims apply to infant formulas and
conditions for their use


Table. 1
Nutrition claims
---- -------------------------------------------
--------------------------------------------
Nutrition claim related the conditions for their use
------------------------------------------ - ------------------------------------------------ | || Only content lactose is the only carbohydrate present
------------------------------------- -------------------------------------------- ------ ----
absence lactose lactose content does not exceed 2.5 mg / 100 kJ
(10 mg / 100 kcal). ---- -------------------------------------------
-------------------------------------------- ADDED polyunsaturated fatty
acids docosahexaenoic acid content represents
long chain or the equivalent of at least 0.2% of the total fatty
nutritional claims related to the addition of acids docosahexaenoic acid

------------ ------------------------------- ------------------- -----------------------------
Content taurine Optionally added in a quantity suitable for
intended use for infants and in accordance with
the conditions laid down in Annex no. 1 of this
Decree.
Fructooligosaccharide and galactooligosaccharide



Content nucleotides ------------------------------------------ - ------------------------------------------------ | ||
Table. 2
Health claims
---- -------------------------------------------
--------------------------------------------
Health claim Conditions
for their use (including claims on reducing the risk of disease
) related to
---------------------------- --------------- -----------------------------------
------------- Reduction of risk to allergy to milk proteins; On the evidence of the claimed properties must
this health claim may be available objective and scientifically verified
terms referring to reduced allergen findings.
Or reduced antigenic properties. Infant formulas must comply
provisions set out in paragraph 2.2 of Annex no.
1 hereof and the amount of immunoreactive
protein measured generally acceptable
methods must be less than 1% of substances
containing nitrogen present in the diet.
Label must state that the product should not be
consumed by infants who are allergic to
intact proteins from which the product
made unless generally accepted clinical
tests provide proof of the initial
baby food tolerance in vícenež 90%
infants who are hypersensitive to proteins from
which the hydrolyzate is made (
interval 95% confidence).
Orally administered infant formulas
not in animals cause hypersensitivity
intact proteins from which the initial
infant formulas are manufactured. ---- -------------------------------------------
--------------------------------------------
Appendix 5



Reference values ​​for vitamins and minerals for labeling of nutritional values ​​


Table. 1

Cereal-based foods for infants and young children
----------------------------------- --------------------
Vitamin / mineral unit Reference substance
value

labeling ---------------------------------------------- ---------
Vitamin A 400 mcg Vitamin D

10 mcg Vitamin C 25 mg

0.5 mg thiamine, riboflavin 0.8 mg equivalents
9 mg of niacin
Vitamin B6 0.7 mg
folic acid 100 mcg Vitamin B12 mcg

0.7 mg Calcium 400 mg Iron 6


Zinc 4 mg iodine
70 mcg selenium 10 mcg

0.4 mg copper ------------------------------- ------------------------

Table no. 2: Initial and follow-on formulas

----------------------------------------------- --------
Vitamin / mineral unit Reference substance
value

labeling ---------------------------------------------- ---------
Vitamin A 400 mcg Vitamin D

7 mcg Vitamin E mg TE *) 5
Vitamin K 12 mcg
Vitamin C 45 mg
thiamine 0.5 mg 0.7 mg Riboflavin


7 Niacin mg Vitamin B6 0.7 mg
folic acid 125 mcg Vitamin B12 mcg

acid 0.8 mg 3 pantothenic


10 mcg Biotin mg Calcium 550 mg Phosphorus 550


1000 mg Potassium Sodium 400 mg 500 mg chloride


Iron 8 mg Zinc 5 mg iodine

80 mcg selenium 20 mcg Copper

0.5 mg Magnesium 80 mg 1.2 mg Manganese

----------- -------------------------------------------- *
) tokoferolekvivalent

Annex 6


The content of amino acids in breast milk

Table. 1

Content of the essential, conditionally essential amino acids in breast milk
(expressed in mg / 100 kcal, and in mg / 100 kcal)

-----------------------------------------------
amino acid to 100 kJ *) Per 100 kcal *)
--------------------------------- --------------

Cystine 9 38 Histidine 10 40 Isoleucine 22 90


Leucine Lysine 40,166 27,113 5 Methionine
23

Phenylalanine 20 Threonine 83 18 77 Tryptophan

Tyrosine 8 32 18 76 21 88 Valin

----------------- ------------------------------
*) 1 kJ = 0.239 kcal


Table. 2

The content of amino acids in the reference protein casein
---------------------------------------


Amino acid Amount g / 100 g


--------------------------------------- protein arginine 3.7 cystine 0.3


Histidine 2.9 Isoleucine 5.4 Leucine 9.5


Methionine Lysine 8,1 2,8 5,2 Phenylalanine
| ||
Threonine 4,7 Tryptophan 1,6 Tyrosine 5,8


Valin 6.7 -------------------- -------------------
Annex 7


Requirements basic cereal based food composition (values ​​relating
ready for use according to manufacturer's instructions)

First Cereal-based foods are produced from one or more milled cereals and / or
ingredients coming from starchy root

Second Content of cereals and / or starchy root shall not be less than 25% by weight in the dry state
Product
-----------------------------------------------------------------------------------------------------------------------------
Other criterion cereal Minimum Maximum Note
výživy1) g / 100 kcal g / 100 kJ
(G / 100 kcal) (g / 100 kcal)
-----------------------------------------------------------------------------------------------------------------------------
First Protein B, D 1.3 (5.5) B - added protein content must be at least
0,48 g / 100 kJ (2 g / 100 kcal)
D - for products with added component with a high content

Protein may be the amount of added protein higher
than 0.36 g / 100 kJ (1.5 g / 100 kcal)
The chemical index of the added protein must be at least
80% of the reference protein chemical - casein
specified in Annex no. 6 tab. no. 2, or coefficient
effectiveness of the protein mixture (PER) in the product must
be at least 70% of that of
with reference protein.
The addition of amino acids is permitted only to improve
nutritional value of the protein mixture, and only in necessary
amount.
-----------------------------------------------------------------------------------------------------------------------------
Second Added carbohydrates, D 1.8 (7.5) of which may be a maximum addition of fructose
(sucrose, fructose, total added 0.9 g / 100 kJ (3.75 g / 100 kcal)
glucose , carbohydrates glucose syrup or honey
)
B 1.2 (5) of the addition of fructose can be up
0.6 g / 100 kJ (2.5 g / 100 kcal)
-----------------------------------------------------------------------------------------------------------------------------

Third Fats A, D 0.8 (3.3)

B 1.1 (4.5) When a fat content higher than 0.8 g / 100 kJ
(3.3 g / 100 kcal), then the contents:
- Lauric acid may be a maximum of 15% of the total
fat content,
- Myristic acid not exceeding 15% of the total
fat content,
- Linoleic acid (in the form of glycerides) shall be
at least 0.07 g / 100 kJ (0.3 g / 100 kcal) and at most
0.285 g / 100 kJ (1.2 g / 100 kcal)

-----------------------------------------------------------------------------------------------------------------------------
Fourth Mineral substances
-----------------------------------------------------------------------------------------------------------------------------
Sodium (Na) A, B, C, D 0.025 (0.1), sodium salts may be added only in cases where
it necessary for technological reasons.
-----------------------------------------------------------------------------------------------------------------------------
Calcium (Ca) B 0.02 (0.08)
-----------------------------------------------------------------------------------------------------------------------------
D 0.012 (0.05) for the products manufactured using milk
(Mléčnésušenky)
-----------------------------------------------------------------------------------------------------------------------------
Fifth Vitamins
-----------------------------------------------------------------------------------------------------------------------------
Thiamine A, B, C, D, 25 mcg (100 mcg)
-----------------------------------------------------------------------------------------------------------------------------
Vitamin A (RE) 2) B 14 mcg (60 microg)
43 mcg (180 mcg)
-----------------------------------------------------------------------------------------------------------------------------

Vitamin D3) B 0.25 microg (1 mcg) 0.75 microg (3 microg)
-----------------------------------------------------------------------------------------------------------------------------

1) A = single cereal products, in particular cereal slurry to be
prepared by adding milk or other nutritious fluids.
B = grain products with added food rich in protein,
especially obilnomléčné porridge.
C = pasta, which are eaten after cooking in boiling water
or other liquid.
D = rusks and biscuits which are eaten directly or after
grinding and mixing with water, milk or other suitable
fluid.
2) RE = all trans-retinolekvivalent.
3) In the form of cholecalciferol, of which 10 microg = 400 IU vitamin.
Limits for vitamin A and vitamin D is also the case that

These vitamins are added to other processed cereal-based foods.
Appendix 8


Requirements for basic composition FOODS (requirements relating
ready for use according to the manufacturer's instructions)
----------------------- -------------------------------------------
Proteins
first -------------------------------------------- ----------------------
a) If a part of the product name as a single ingredient meat
poultry, fish, offal or other common sources of protein, it must form
:
first the proportion of meat, poultry, fish, offal or other conventional sources of protein
total of at least 40% of the total weight
product
second each individually listed components (meat, poultry, fish offal
or other conventional sources of protein) of at least 25% by weight of all
used protein sources
third protein from these sources shall not be less than 1.7
g / 100 kJ (7 g / 100 kcal).
----------------------------------------------- -------------------
b) If meat, poultry, fish, offal or other
usual sources of protein, singularly or in combination listed in the product name
at first, then must form regardless of whether the product is intended as a food
:
first that proportion of meat, poultry, fish, offal or other
usual sources of protein in the sum of at least 10% of the total weight of the product
,
second each individually listed components (meat, poultry, fish offal
or other conventional sources of protein) of at least 25% by weight of the packaging
named protein sources
third the protein from the named sources at least 1 g / 100 kJ (4
g / 100 kcal).
----------------------------------------------- -------------------
c) If meat, poultry, fish, offal or other
usual sources of protein, singularly or in combination listed in the product name ,
but not in the first place, it must be irrespective of whether
product is intended as a meal, constitute:
first that proportion of meat, poultry, fish, offal or other
usual sources of protein in the sum of at least 8% of the total weight of the product
,
second each individually listed components (meat, poultry, fish offal
or other conventional sources of protein) of at least 25% by weight of all
used protein sources
third protein content from these sources than 0,5 g / 100 kJ (2.2
g / 100 kcal) and total protein content from all sources
shall not be less than 0.7 g / 100 kJ (3 g / 100 kcal).
----------------------------------------------- -------------------
d) when in the product name together with other ingredients listed cheese, then
regardless of whether the product is intended as food, must be:
first protein content of milk protein less than 0.5 g / 100 kJ (2.2
g / 100 kcal)
second total protein content from all sources of less than 0.7 g / 100 kJ
(3 g / 100 kcal).
----------------------------------------------- -------------------
e) If the product is designated as a separate dish, except
vegetable trimmings, but the name is not meat, poultry,
fish, offal or other common protein sources must be
total protein content from all sources of at least 0.7 g / 100 kJ
(3 g / 100 kcal).
----------------------------------------------- -------------------
f) requirements referred to in letters a), b), c), d) and e) does not apply to
sauces intended as an annex .
----------------------------------------------- -------------------
g) sweet foods, which states the name of the product such as milk component
first or only ingredient must contain at least 2.2 g
milk protein per 100 kcal. For all other sweet foods
not apply the requirements referred to in letters a), b), c), d)
e), f) and g).
----------------------------------------------- -------------------
h) addition of amino acids is permitted only to improve the nutritional value
present proteins solely in an amount which is
necessary for this purpose.
----------------------------------------------- -------------------
Carbohydrates second
-------------------------------------------- ----------------------
amount of total carbohydrates present in fruit and vegetable
juices and nectars, baby foods composed of fruits and desserts
or puddings shall not exceed -------------------------------------------
-----------------------
) 10 g / 100 ml for vegetable juices and drinks based on them,
----- --------------------------------------------------
----------- b) 15 g / 100 ml for fruit juices and nectars and drinks from them
prepared,

----------------------------------------------- -------------------
c) 20 g / 100 g based foods composed of fruits,
------------- -------------------------------------------------- ---
d) 25 g / 100 g for desserts and puddings
------------------------------ ------------------------------------
e) 5 g / 100 mL in other beverages, unless they are prepared from milk
).
----------------------------------------------- -------------------
3. Fat
--------------------------------------------
---------------------- the following requirements relate to other foods, where the
as a single component in the product name meat, poultry, fish
offal or other traditional protein source.
----------------------------------------------- -------------------
a) If meat or cheese only component, the title, or
are listed in the product name in the first place, then the total content
fat in the product from all sources should not exceed 1,4 g / 100 kJ (6
g / 100 kcal).
B) In all other products the total fat in the product from
all sources should not exceed 1,1 g / 100 kJ (4.5 g / 100 kcal).
----------------------------------------------- -------------------
4th Sodium (Na)
----------------------------------------- -------------------------
a) the sodium content in the product should not exceed 48 mg / 100 kJ (200
mg / 100 kcal), if necessary. than 200 mg / 100 g. If the only ingredient
the title product cheese must not be higher than the sodium content
70 mg / 100 kJ (300 mg / 100 kcal).
----------------------------------------------- -------------------
b) to the products from fruits, desserts and puddings may not be added
no sodium salt, with the exception of those that are added | || technological reasons.
----------------------------------------------- -------------------
Vitamins fifth
-------------------------------------------- ----------------------
a)
vitamin C in fruit juices and nectars and vegetable juices must be
vitamin C content of at least 6 mg / 100 kJ (25 mg / 100 kcal) or not
less than 25 mg / 100 g.
----------------------- -------------------------------------------
b) Vitamin A
In vegetable juices, vitamin content must be less than 25
microgram / 100 kJ (100 microgram / 100 kcal).
Into other kinds of trimmings from a group other than cereal may not be
vitamin A is added.
----------------------------------------------- -------------------
c) vitamin D
to other kinds of trimmings from a group other than cereal may not be
vitamin D added.
----------------------------------------------- -------------------
Appendix 9


Requirements for identity supplements that can be used in the production
cereal and other foods
first vitamins

----------------------------------------------- -----------------------
Vitamin A Vitamin D
Retinol Vitamin D2 (ergocalciferol =)
Retinyl acetate Vitamin D3 (= cholecalciferol)
Retinyl palmitate Beta-carotene

--------------------------------- -------------------------------------
Vitamin B1, Vitamin B2
Thiamine hydrochloride Riboflavin
Thiamine mononitrate Riboflavin-5-phosphate sodium
----------------------------------- -----------------------------------
Niacin Vitamin B6 pyridoxine hydrochloride Nicotinamide

nicotinic acid Pyridoxine-5'-phosphate
Pyridoxine dipalmitate
--------------------------------------------- -------------------------
pantothenic acid Folate
calcium D-pantothenate folic acid
D-pantothenate, sodium
dexpanthenol
---------------------------------------------- ------------------------

biotin Vitamin B12 Cyanocobalamin D-biotin Hydroxykobalamin

------ -------------------------------------------------- --------------
Vitamin C Vitamin E
L-ascorbic acid D-alpha-tocopherol
L-sodium ascorbate DL-alpha-tocopherol
L- ascorbate, calcium D-alpha tocopherol acetate
potassium ascorbate, DL-alpha-tocopherol acetate
ester of L-ascorbic acid and 6
palmityl palmitate Ascorbyl

-------- -------------------------------------------------- ------------

Vitamin K phylloquinone (fytometadion)
----------------------- -----------------------------------------------

Second amino acids

----------------------------------------------- -----------------------
L-arginine and its hydrochloride
L-cystine and its hydrochloride
L-histidine and its hydrochloride
L-isoleucine and its hydrochlorides


L-leucine and its hydrochlorides
L-lysine and its hydrochloride
L-cysteine ​​and its hydrochlorides

L-methionine L-phenylalanine L-threonine

L-
tryptophan L-tyrosine L-valine

---------------------------------- ------------------------------------

Third Other organic substances

----------------------------------------------- -----------------------

choline chloride choline citrate

choline bitartrate choline (choline bitartrate)
Inositol

L-carnitine hydrochloride L-carnitine
---------------------------------- ------------------------------------

Fourth Salts of minerals and trace elements

----------------------------------------------- -----------------------

calcium magnesium carbonate calcium magnesium carbonate calcium chloride

calcium magnesium chloride acid salts. citric magnesium salts of citric acid
calcium gluconate, magnesium gluconate, calcium glycerophosphate

magnesium oxide, calcium lactate, magnesium hydroxide, calcium oxide
acid magnesium salt
calcium hydroxide Tribasic phosphate
calcium salt magnesium sulphate | || Tribasic fosforečnaté magnesium lactate
Magnesium glycerophosphate
--------------------------------------------- -------------------------
Iron potassium chloride potassium citrate

ferrous potassium salts of citric acid, ferric ammonium citrate || | gluconate, potassium gluconate, ferrous lactate, potassium lactate

glycerophosphate, iron, potassium sulphate, iron
Iron fumarate
Ferric pyrophosphate
Elemental iron (
of
hydrogenation of carbonyl iron or electrolytically)
Sacharan iron
Ferric pyrophosphate, sodium
Ferrous carbonate
--------------------------------------------- -------------------------

copper, zinc and copper complex lysine acetate, zinc carbonate

copper zinc citrate copper citrate, zinc gluconate, copper

Birch copper sulfate zinc sulfate
Zinc Oxide
Zinc gluconate
--------------------------------------------- -------------------------

Iodine Manganese manganese carbonate, sodium iodide, manganese chloride

citrate potassium iodide manganese iodate
potassium, manganese gluconate sodium iodate

manganese sulfate, manganese glycerophosphate
----------------------------- -----------------------------------------
Annex 10


Requirements for the maximum amounts of vitamins and minerals and trace elements
if they are added to processed cereal-based foods
intended for infants and young children (values ​​relate
food prepared according to directions for use manufacturer. Only requirements
potassium and calcium refer to the product in which it is sold
.)
-------------------- -------------------------------------------------- ----------
Vitamins and minerals the maximum amount of the maximum amount
100 kcal per 100 kJ
----------------------------------------- ---------------------------------------
Vitamin A (mcg RE) 1801)
42.9 -------------------------------------------- ------------------------------------
Vitamin E (mg a-TE) 3 0, 7
---------------------------------------------- ----------------------------------
Vitamin C (mg) 12.5 / 252) / 1253 ) ----------------------------------------- 03/06/30
---------------------------------------
Thiamin (mg) 0.25 / 0.54) 0.06 / 0.12 ------------------------------------
--------------------------------------------
Riboflavin (mg ) 0.4 0.1 ----------------------------------------
----------------------------------------
Niacin (mg NE) 4, 5 1.1 -------------------------------------------
-------------------------------------
Vitamin B6 (mg) 0.35 0 08
---------------------------------------------- ----------------------------------
Folate (mcg) 50 11.9
- -------------------------------------------------- -----------------------------
Vitamin B12 (mcg) 0.35 0.08

----------------------------------------------- ---------------------------------
pantothenic acid (mg) 1.5 0.36
-------------------------------------------------- ------------------------------
Biotin (mcg) 10 2.4 ------
-------------------------------------------------- ------------------------
Potassium (mg) 160 38 --------------
-------------------------------------------------- ----------------
Calcium (mg) 80/1805) / 1006) 19/43/24 ------------
-------------------------------------------------- ------------------
Magnesium (mg) 40 9.5
------------------ -------------------------------------------------- ------------
Iron (mg) 3 ------------------------ 0.7
-------------------------------------------------- ------
Zinc (mg) 2 0.5 ------------------------------
--------------------------------------------------
Copper (mcg) ------------------------------------ 40 9.5
--------------------------------------------
Iodine (microg ) 35 8.3 ------------------------------------------
--------------------------------------
Manganese (mg) 0.6 0 14
---------------------------------------------- ----------------------------------

1) Does not apply to the amount of vitamin A in Annexes Nos. 7 and # 8.

2) Amount applicable to products fortified with iron.

3) Amount applicable to fruit-based dishes, fruit juices, nectars and vegetable juices
.

4) Amount applicable to cereal-based foods.

5) Amount applicable to products listed in group A and B in the Annex
no. 7th

6) Amount applicable to products listed in Group D in Annex no. 7.
Annex 11


Pesticides which shall not be used for agricultural production materials
intended for the production of infant nutrition and
production of grain and other nutrition other than corn intended for feed
infants and young children
Table. 1

----------------------------------------------- -------------------
Chemical name of the substance (residue definition)
------------------ ------------------------------------------------ || | disulfoton (sum of disulfoton, disulfoton sulfoxide and
sulfone expressed as disulfoton)
--------------------------- ---------------------------------------
fensulfothion (sum of fensulfothion, its oxygen
analogue and their sulfones, expressed as fensulfothion)
----------------------------------- -------------------------------
Fentin, expressed as cation triphentinu
------- -------------------------------------------------- ---------
haloxyfop (sum of haloxyfop, its salts and esters including
conjugates, expressed as haloxyfop)
--------------- -------------------------------------------------- -
heptachlor and trans-heptachlor epoxide, expressed as heptachlor
--------------------------------- --------------------------------- Hexachlorbenzene
----------
-------------------------------------------------- ------

Nitrofen -------------------------------------

omethoate ----------------------------- -------------- -------------------------------------------------- -
terbufos (sum of terbufos, its sulfoxide and sulfone, expressed as terbufos
)
------------------------ ------------------------------------------

Table no. 2

----------------------------------------------- -------------------
Chemical name --------------------------------------------
----------------------
Aldrin and dieldrin, expressed as dieldrin
--------------- -------------------------------------------------- -

Endrin ------------------------------------------ ------------------------
Annex 12


Specific maximum residue levels of pesticides or metabolites of pesticides in
infant formulas and cereals and other nutrition
other than corn intended for infants and young children
--------- -------------------------------------------------- -------
Chemical name of the substance Maximum
residue levels (mg / kg)
-----------------------------------------
cadusafos ------------------------- ----------------- 0,006
------------------------------------------------- | || demeton-S-methyl / demeton-S-methyl sulfone 0.006
/ oxymeton-ethyl (
individually or in combination, expressed as demeton-S-methyl)
-------- -------------------------------------------------- --------


Ethoprophos 0,008 ------------------------------------------ ------------------------
fipronil (sum of fipronil and fipronil- 0,004
desulfinyl expressed as fipronil)
- -------------------------------------------------- --------------
propineb / propylenthiomočovina (sum of propineb and 0,006
propylenthiomočoviny)
----------------- ------------------------------------------------- | || Annex 13



Canceled Annex 14


Specification content, source and processing of protein used in the manufacture
infant formulas with a protein content less than
0.56 g / 100 kJ (2.25 g / 100 kcal) made from hydrolysed || | whey protein derived from cows' milk protein

----------------------------------------------- ---------------------
criterion Minimum Maximum Note
------------------- ------------------------------------------------- | || first Content of 0.44 0.7 g / 100 Content
protein g / 100 kJ kJ (3 =
protein (1.86 g / 100
content g / 100 kcal) of nitrogen x
kcal)
6.25 -------------------------------------------- ------------------------
second
Protein source Proteins from demineralised sweet whey protein derived from cows' milk
after enzymatic precipitation of caseins using
chymosin, consisting of the following:
a) 63% isolates of whey proteins with no casein
glycomacropeptide with a minimum protein content
95% and less than 70% protein denaturation and ash content
not more than 3%, and
b) 37% protein concentrate of sweet whey with a minimum
protein content 87% and less than 70% denaturation
protein and a maximum ash content of 3.5%.
----------------------------------------------- ---------------------
third Protein processing
two-stage hydrolysis process using a trypsin preparation
wherein between the two stages of hydrolysis occurs
heat treatment (3-10 minutes at 80 to 100 ° C).
Annex 15


Requirements for the composition of food for slimmers (values ​​refer to the products
adapted for use according to the manufacturer's instructions)
TABLE 1


First Energy
---------------------------------------------- --------------------
a) The amount of energy supplied food according to § 10 paragraph. 1 point.
A) in a daily dosage should be at least 3360 kJ (800 kcal) and at most 5040
kJ (1200 kcal).
B) The amount of energy supplied food according to § 10 paragraph. 1 point.
B) in a food should be at least 840 kJ (200 kcal) and at most 1680
kJ (400 kcal).
----------------------------------------------- -------------------

Second Proteins
---------------------------------------------- --------------------
a) For food according to § 12 para. 1 point. a) and b) they must be delivered
proteins contained at least 25% and up to 50% energy.
Protein content in foods under § 12 para. 1 point. a) shall not exceed 125 g
daily dose.
B) The requirements set out in paragraph a) are based on a protein, chemical
whose index is equal to the chemical index reference
protein. If the chemical index of the proteins present in a mixture
foodstuff lower than 100% of the reference chemical
protein must be the amount of protein in food
correspondingly improved. The chemical index of the protein mixture in a food
must in any case be 80% of the reference protein.
C) 'chemical' index means the lowest ratio between the amount
each essential amino acid protein blended food
ie. compared the protein, and the amount of that amino acid in the reference protein
.
D) For the sole purpose of increasing the nutritional value of protein is allowed
addition of amino acids, and only in quantities for this purpose
necessary.
----------------------------------------------- -------------------

Third Fats
---------------------------------------------- --------------------
a) the amount of energy in food derived from fat shall not exceed
30% of the total amount of energy.
B) For food according to § 12 para. 1 point. a) it must be acid content
linoleic (in the form of glycerides) at least 4.5 g daily dose.
B) For food according to § 12 para. 1 point. b) it must be acid content
linoleic (in the form of glycerides) at least 1 g daily dose.
----------------------------------------------- -------------------

Fourth Fiber
---------------------------------------------- --------------------

For food according to § 12 para. 1 point. and must be
fiber content of at least 10 g and not more than 30 g in a daily dose.
----------------------------------------------- -------------------

Fifth Vitamins and minerals -------------------------------------------
-----------------------
a) For food according to § 12 para. 1 point. a) represent the contents
vitamins and minerals in the daily food ration
least 100% of the values ​​listed in Table No. 2.
b) For food according to § 12 para. 1 point. b) represent the contents
vitamins and minerals in a food at least 30%
values ​​given in table no. 2, with the amount of potassium in
one portion must be less than 500 g.
- -------------------------------------------------- ---------------
TABLE 2


Amounts of vitamins and minerals

----------------------------------------------- -------------------
Vitamin A (mcg) RE * 700
----------------- ------------------------------------------------- | || Vitamin D (mcg) 5
--------------------------------------- ---------------------------
Vitamin E (mg) 10 TE **
-------- -------------------------------------------------- --------
Vitamin C (mg) 45 ------------------------------
------------------------------------
Thiamin (mg) 1.1
- -------------------------------------------------- ---------------
Riboflavin (mg) 1.6 ----------------------
--------------------------------------------
Niacin (mg ) *** NO 18
----------------------------------------- -------------------------
Vitamin B6 (mg) 1.5 -----------
-------------------------------------------------- -----
Folate (mcg) 200 ---------------------------------
---------------------------------
Vitamin B12 (mcg) 1.4 ---
--------------------------------------------------
------------- Biotin (mcg) -------------------------- 15
----------------------------------------
pantothenic acid (mg) 3 | || ------------------------------------------------ ------------------
Calcium (mg) 700 ---------------------
---------------------------------------------
Phosphorus ( mg)
550 -------------------------------------------- ----------------------
Potassium (mg) 3100 -----------------
------------------------------------------------- | || Iron (mg) 16 ----------------------------------------
--------------------------
Zinc (mg) 9.5 -----------
-------------------------------------------------- -----
Copper (mg) 1.1
-------------------------------- ----------------------------------
Iodine (mcg) 130 -----
-------------------------------------------------- -----------
Selenium (mcg) ---------------------------- 55
--------------------------------------
Sodium (mg) 575
- -------------------------------------------------- ---------------
Magnesium (mg) 150 ------------------------
------------------------------------------
Manganese (mg) 1
----------------------------------------------- -------------------

* RE = trans-retinolekvivalent
** TE = alpha tokoferolekvivalent
*** NO = niacinekvivalent
TABLE 3


The contents of amino acids in the reference protein

----------------------------------------------- -------------------
amino acid g / 100 g of protein
------------------- -----------------------------------------------
cystine + methionine ----------------------------------------- 1.7
-------------------------

Histidine 1.6 --------------- -------------------------------------------------- -

Isoleucine 1.3 --------------------------------------- Leucine 1.9 ---------------------------

------------- -------------------------------------------------- ---

Lysine 1.6 ------------------------------------- -----------------------------
Phenylalanine + tyrosine 1.9 ---------
-------------------------------------------------- -------

Threonine 0.9 ---------------------------------
Tryptophan 0.5 --------------------------------- -------
--------------------------------------------------
Valin --------- ------------------------------- 1.3
-----------------------------------


Annex 16 TABLE 1


Requirements for the composition of dietary foods for special medical purposes

----------------------------------------------- -------------------
first Nutritionally complete foods with a standard formulation by
§ 13 paragraph. 2 point. a) intended for infants must contain
vitamins and minerals as shown in Table No. 2.

Second Nutritionally complete food specifically adapted
composition according to § 13 para. 2 point. b) intended for infants must
contain vitamins and minerals according to Table. 2. Content
one or more of these substances (food supplements)
may only change, if it is necessary for the
specific destination and intended use of the food.

Third For food nutritionally incomplete according to § 13 para. 2 point. c)
intended for infants, the content of vitamins and mineral substances
exceed the values ​​shown in Table No. 2.
contents of one or more of these substances (food supplements) may change
only is if it is necessary for the specific destination and
intended use of the food.

Fourth Foods listed in § 12 para. 1 and 2 intended for infants
containing other nutrients must comply with the requirements of this ordinance
if these do not conflict with their specific
purpose and intended use.

Fifth Nutritionally complete foods with a standard formulation according to § 13 paragraph
. 2 point. a) that are not intended for infants, must
contain vitamins and minerals under the table no. 3.

6th Nutritionally complete food specifically adapted
composition according to § 13 para. 2 point. b) which are not intended for nutrition of infants
must contain vitamins and minerals according
Table. 3. The content of one or more of these substances (food supplements
) may change only when it is necessary for the
specific destination and intended use of the food.

7th For food nutritionally incomplete according to § 13 para. 2 point. c)
not intended for infants, not vitamins and minerals
exceed the values ​​listed in Table # 3.
contents of one or more of these substances (food supplements) may be
only be changed if it is necessary for the specific
destination and intended use of the food.
----------------------------------------------- -------------------
TABLE 2


The requirements for vitamins and minerals
for dietary foods for special medical purposes
for infant feeding

--------------------------------------------------------------------------------------------------------------
Vitamins / unit: 100 kJ per 100 kcal
-------------------------------------------------- -------------------------------
Minimum Maximum Minimum Maximum
--------------------------------------------------------------------------------------------------------------
Vitamin A (mcg) RE * 14 43 60 180
--------------------------------------------------------------------------------------------------------------

Mangan (mcg) 0.25 25 1100
--------------------------------------------------------------------------------------------------------------
Vitamin K (mcg) 1 5 4 20
--------------------------------------------------------------------------------------------------------------
Vitamin C (mg) 1.9 6 8 25
--------------------------------------------------------------------------------------------------------------
Thiamine (mg) 0.01 0.075 0.04 0.3
--------------------------------------------------------------------------------------------------------------
Riboflavin (mg) 0.014 0.06 1 0.45
--------------------------------------------------------------------------------------------------------------
Vitamin B6 (mg) 0.009 0.075 0.035 0.3
--------------------------------------------------------------------------------------------------------------
Niacin (mg) NE ** 0.2 0.75 0.8 3
--------------------------------------------------------------------------------------------------------------
Folic Acid (mcg) 1 6 4 25
--------------------------------------------------------------------------------------------------------------
Vitamin B12 (mcg) 0.025 0.12 0.1 0.5

--------------------------------------------------------------------------------------------------------------
Pantothenic acid (mg) 0.07 0.5 0.3 2
--------------------------------------------------------------------------------------------------------------
Biotin (mcg) 0.4 5 1.5 20
--------------------------------------------------------------------------------------------------------------
Vitamin E (mg alpha-TE) *** 0.5 0.75 to 1 g per 1 g of 0.5 to 1 g per 1 g of 3
Polyunsaturated polyunsaturated polyunsaturated polyunsaturated
fatty acids, fatty acids, fatty acid mastnýchkyselin
expressed as expressed as expressed as expressed as
linoleic acid, linolenic acid, linolovákyselina, linoleic acid,
but no but no but no but no
if not less if no less the case if no less no less
than 0.1 mg per 100 than 0.1 mg per 100 than 0.5 mg per 100 than 0.5 mg per 100
kJ available available available kJ kcal available kcal
--------------------------------------------------------------------------------------------------------------
Sodium (mg) 5 14 20 60
--------------------------------------------------------------------------------------------------------------
Chloride (mg) 12 29 50 125
--------------------------------------------------------------------------------------------------------------
Potassium (mg) 15 35 60 145
--------------------------------------------------------------------------------------------------------------
Calcium (mg) 12 60 50 250
--------------------------------------------------------------------------------------------------------------
Phosphorus (mg) 1) 6 22 25 90
--------------------------------------------------------------------------------------------------------------
Magnesium (mg) 1.2 3.6 5 15
--------------------------------------------------------------------------------------------------------------
Iron (mg) 0.12 0.5 0.5 2
--------------------------------------------------------------------------------------------------------------
Zinc (mg) 0.12 0.6 0.5 2.4
--------------------------------------------------------------------------------------------------------------
Copper (mcg) 4.8 29 20 120
--------------------------------------------------------------------------------------------------------------
Iodine (mcg) 1.2 8.4 5 35
--------------------------------------------------------------------------------------------------------------
Selenium (mcg) 0.25 0.7 1 3
--------------------------------------------------------------------------------------------------------------
Manganese (mg) 0.012 0.05 0.05 0.2
--------------------------------------------------------------------------------------------------------------
Chromium (mcg) - 2.5 - 10
--------------------------------------------------------------------------------------------------------------
Molybdenum (mcg) - 2.5 - 10
--------------------------------------------------------------------------------------------------------------
Fluoride (mg) - 0,05 - 0,2
--------------------------------------------------------------------------------------------------------------

1) The ratio of calcium to phosphorus shall not be lower than 1.2 or higher than 2.0.

* RE = trans-retinoekvivalent
** NO = niacinekvivalent
*** TE = alpha tokoferolekvivalent
TABLE 3


The requirements for vitamins and minerals
for dietary foods for special medical purposes,
not intended for infants

------------------------------------------------------------------------------------------------------------------------
Vitamins / unit: 100 kJ per 100 kcal
-------------------------------------------------- -----------------------------------------
Minimum Maximum Minimum Maximum
------------------------------------------------------------------------------------------------------------------------

Vitamin A (mcg) RE * 8.4 43 35 180
------------------------------------------------------------------------------------------------------------------------
Vitamin D (mcg) 0.12 0.65 / 0.751) 0.5 2.5 / 31)
------------------------------------------------------------------------------------------------------------------------
Vitamin K (mcg) 0.85 5 3.5 20
------------------------------------------------------------------------------------------------------------------------
Vitamin C (mg) 0.54 5.25 2.25 22
------------------------------------------------------------------------------------------------------------------------
Thiamin (mg) 0.015 0.12 0.06 0.5
------------------------------------------------------------------------------------------------------------------------
Riboflavin (mg) 0.02 0.12 0.08 0.5
------------------------------------------------------------------------------------------------------------------------
Vitamin B6 (mg) 0.02 0.12 0.08 0.5
------------------------------------------------------------------------------------------------------------------------
Niacin (mg) NE ** 0.22 0.75 0.9 3
------------------------------------------------------------------------------------------------------------------------
Folic Acid (mcg) 2.5 12.5 10 50
------------------------------------------------------------------------------------------------------------------------
Vitamin B12 (mcg) 0.017 0.17 0.07 0.7
------------------------------------------------------------------------------------------------------------------------
Pantothenic acid (mg) 0.035 0.35 0.15 1.5
------------------------------------------------------------------------------------------------------------------------
Biotin (mcg) 0.18 1.8 0.75 7.5
------------------------------------------------------------------------------------------------------------------------
Vitamin E (mg alpha-TE) *** 0.5 0.75 to 1 g per 1 g of 0.5 to 1 g per 1 g of 3
Polyunsaturated polyunsaturated polyunsaturated polyunsaturated
fatty acids, fatty acids, fatty acids, fatty acid
expressed as expressed as expressed as expressed as
linoleic acid, linolenic acid, linoleic acid, linolenic acid,
but no but no but no but no
if not less if no less the case if no less no less
than 0.1 mg per 100 than 0.1 mg per 100 than 0.5 mg per 100 than 0.5 mg per 100
kJ available available available kJ kcal available kcal
------------------------------------------------------------------------------------------------------------------------
Sodium (mg) 7.2 42 30 175
------------------------------------------------------------------------------------------------------------------------
Chloride (mg) 7.2 42 30 175
------------------------------------------------------------------------------------------------------------------------
Potassium (mg) 19 70 80 295
------------------------------------------------------------------------------------------------------------------------
Calcium (mg) 8.4 / 121) 42/601) 35/501) 175/2501)
------------------------------------------------------------------------------------------------------------------------
Phosphorus (mg) 1) 7.2 19 30 80
------------------------------------------------------------------------------------------------------------------------
Magnesium (Mg) 1.8 6 25 7.5
------------------------------------------------------------------------------------------------------------------------
Iron (mg) 0.12 0.5 0.5 2.0
------------------------------------------------------------------------------------------------------------------------
Zinc (mg) 0.12 0.36 0.5 1.5
------------------------------------------------------------------------------------------------------------------------

Copper (mcg) 15 125 60 500
------------------------------------------------------------------------------------------------------------------------
Iodine (mcg) 1.55 8.4 6.5 35
------------------------------------------------------------------------------------------------------------------------
Selenium (mcg) 0.6 2.5 2.5 10
------------------------------------------------------------------------------------------------------------------------
Manganese (mg) 0.012 0.12 0.05 0.5
------------------------------------------------------------------------------------------------------------------------
Chromium (mcg) 0.3 3.6 1.25 15
------------------------------------------------------------------------------------------------------------------------
Molybdenum (mcg) 0.72 4.3 3.5 18
------------------------------------------------------------------------------------------------------------------------
Fluoride (mg) - 0,05 - 0,2
------------------------------------------------------------------------------------------------------------------------

1) For products intended for children aged 1-10 years.

* RE = trans-retinoekvivalent
** NO = niacinekvivalent
*** TE = alpha tokoferolekvivalent
Selected provisions of amendments


Art. II Decree no. 157/2008 Coll.
Transitional provisions


First Food produced or labeled before the effective date of this decree
which are not in accordance with Section 4, Section 5, in terms of § 5, paragraph
. 1-5 paragraphs 6, 21 and 22, and item 29, as regards Annex no. 1
may be put into circulation until 31 December 2009.

Second Foods for special medical purposes intended for infants that
not meet the requirements provided for in point 5, in terms of § 5 para. 4
point. a), b), d) and e) and paragraph 29, as regards Annex no. 1
points 2.1.1 and 2.2.1 and Appendix no. 2, point 2, may be put into circulation until 1.
January, 2012.

1) Council Directive 92/52 / EEC of 18 June 1992 on the initial
and follow-on formulas intended for export to third countries.

Commission Directive 96/8 / EC of 26 February 1996 on foods for
energy-restricted diets for weight reduction.
Commission Directive 1999/21 / EC of 25 March 1999 on dietary foods for special medical purposes
.

Directive of the European Parliament and Council Directive 2000/13 / EC of 20 March 2000
on the approximation of the laws of the Member States relating to the labeling
food, presentation and advertising.

Commission Directive 2006/125 / EC of 5 December 2006 on processed cereal-based foods for
infants and young children.

Commission Directive 2006/141 / EC of 22 December 2006 on the initial
and follow-on formulas and amending Directive 1999/21 / EC.

Commission Directive 2007/29 / EC of 30 May 2007 amending
Directive 96/8 / EC as regards labeling, advertising and presentation
food for energy-restricted diets for weight reduction.

Directive of the European Parliament and Council Directive 2009/39 / EC of 6 May 2009
on foodstuffs intended for particular nutritional uses.

Commission Directive 2013/46 / EU of 28 August 2013 amending
Directive 2006/141 / EC as regards requirements for protein
initial and follow-on formulas.

1) Regulation of the European Parliament and Council Regulation (EC) no. 1924/2006 of 20
December 2006 on nutrition and health claims made on foods
.

Regulation of the European Parliament and Council Regulation (EC) no. 1925/2006 of 20
December 2006 on the addition of vitamins and minerals and of certain other substances to
foods.

Commission Regulation (EC) no. 1609/2006 of 27 October 2006 for two years
authorizing the placing on the market of infant formulas
based on hydrolysates of whey protein derived from cows' || | milk.

Commission Regulation (EC) no. 2073/2005 of 15 November 2005
microbiological criteria for foodstuffs.

Commission Regulation (EC) no. 1441/2007 of 5 December 2007 laying
amending Regulation (EC) no. 2073/2005 on microbiological criteria for foodstuffs
.

Commission Regulation (EC) no. 41/2009 of 20 January 2009 concerning the composition and
labeling of foodstuffs suitable for people intolerant to gluten.


Commission Regulation (EC) no. 953/2009 of 13 October 2009 on substances that
may be added for specific nutritional purposes in foods for particular nutritional uses
.

Commission Regulation (EC) no. 1243/2008 of 12 December 2008 laying
amending Annexes III and VI to Directive 2006/141 / EC as regards requirements for certain
composition of infant formulas .

1b) European Parliament and Council Regulation (EC) no. 1924/2006 of 20
December 2006 on nutrition and health claims made on foods
.

Regulation of the European Parliament and Council Regulation (EC) no. 1925/2006 of 20
December 2006 on the addition of vitamins and minerals and of certain other substances to
foods.

Commission Regulation (EC) no. 1609/2006 of 27 October 2006 for two years
authorizing the placing on the market of infant formulas
based on hydrolysates of whey protein derived from cows' || | milk.

Commission Regulation (EC) no. 2073/2005 of 15 November 2005
microbiological criteria for foodstuffs.

Commission Regulation (EC) no. 1441/2007 of 5 December 2007 laying
amending Regulation (EC) no. 2073/2005 on microbiological criteria for foodstuffs
.

1c) of the European Parliament and Council Regulation (EC) no. 1925/2006 of 20
December 2006 on the addition of vitamins and minerals and of certain other substances to
foods.

1d) For example, Decree no. 275/2004 Coll., On requirements for quality and
safety of bottled water and the method of editing, as
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
regulations; Law no. 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 conditions of use
additives and extraction solvents in food production.

4) Regulation of the European Parliament and Council Regulation (EC) no. 1924/2006 of 20
December 2006 on nutrition and health claims made on foods
.

5) Decree no. 450/2004 Coll., On the nutritional labeling of food.

6) Annex no. 2 ATC V06 Act no. 48/1997 Coll., On public health
insurance and amending and supplementing some related laws, as
pozdějiších regulations.

7) Commission Regulation (EC) no. 953/2009 of 13 October 2009 on substances
that may be added for specific nutritional purposes in foods for particular nutritional uses
.