84/2001 Sb.
The DECREE
The Ministry of health
of 8 June. February 2001
on the hygiene requirements on toys and products for children under the age of 3
years
Change: 521/2005 Sb.
The Ministry of health provides under section 108, paragraph. 1 of law No.
258/2000 Coll., on the protection of public health and amendment to certain
related laws, (hereinafter referred to as "the Act") for the implementation of section 26, paragraph. 1 (a).
b) and d) (a). 2, 4 and 5:
§ 1
Basic provisions
(1) this Decree lays down the health requirements for the
and) toys which are designed to ensure that children bring into the mouth,
(b)) toys which can in a predictable way of coming into
contact with food and dishes,
(c)) toys for children under the age of 3 years, which may be predictable
How to use with regard to the mental and physical abilities of the child
placed in the mouth,
d) products for children under the age of 3 years, which are as follows by the manufacturer,
the importer or the person who puts into circulation, marked, or are
the use of children under the age of 3 years are clearly intended, with the exception of toys and
food, (hereinafter referred to as "products"); in the case of clothing, the
for the product for children under the age of 3 years, clothing up to size 110, including
the size of 110.
(2) the general health and safety requirements for the toy provides
specific legislation. ^ 1)
(3) the provisions of this Ordinance shall not affect the requirements for products for
children provided for by specific legislation. ^ 2) requirements for cosmetic
resources for children aged up to 3 years old, lays down specific legal
prescription. ^ 3) requirements for products which are intended for children under the age of
3 years and which, in their finished State, are intended to come into contact with foodstuffs
and or are in contact with foodstuffs and dishes and for this
the purpose of the intended, are laid down in a separate legal Act ^ 4).
Products for children
§ 2
(1) products for children must be made so that, under normal or
foreseeable conditions of use have been wholesome, where appropriate,
could not cause any physical damage if swallowed and avoid
the transfer of their ingredients on the skin or mucous membranes in amounts that could
harm the health of children.
(2) products for children shall not contain pathogenic and conditionally pathogenic
micro-organisms.
(3) products for children may exhibit only the odor characteristic of the
the given material.
(4) products for children must not have irritant effects on the skin or mucous membranes.
(5) products for children made from multiple materials is assessed
the materials, which, under normal or foreseeable conditions comes into
contact with the skin or mucous membrane.
(6) the Dyed products for children, which are not due to their
character to exclude contact with mouth, must be resistant to the action of the solution
Testability verification purposes. Products for children of dyed plastic, elastomer and with
coloured coatings must be resistant to the action of the solution
Testability verification purposes. How to test the resistance of material to
effects of sweat and saliva is given in annex 1.
§ 3
Dyeing and printing
(1) for dyeing and printing products for children shall not be applied to the azo dyes
the decomposition of risk arise from aromatic amines listed in the annex
No 2.
(2) for dyeing and printing products for children shall not be used in the dye,
which is indicated by standard phrases indicating the specific
risk phrases (R phrases: R 45, R 46, R-60, R-61) according to a special legal
předpisu2) or has properties, for which the following should be indicated.
May not be used the colouring agents listed in annex No. 3.
(3) the requirements for the purity of the dyes and pigments used for dyeing and
printing of fabrics, including non-woven, used in the manufacture of products for children
Annex No. 4.
(4) dyes and pigments used to dye the surface finishes, plastics or
elastomers used in the manufacture of products for children or their
printing or decoration must be firmly embedded in the products.
(5) products for children referred to in section 7 (2). 1 may be dyed with soot,
that its purity conforms with the requirements laid down in annex 5.
The contents of the soot in the product shall not exceed the 10.0 percent (by weight).
§ 4
Marking and written statements
(1) the product of the dyed fabric, which was due to the unsatisfactory
the result of the carried out repeated the test that verifies the change of colour fastness and
the result of the test is repeated in accordance with the requirements set out in annex
No 10, must contain on the packaging, the label, the label or the label of the product
visible, easily legible and indelible warning "before the first
using the wash ".
(2) products for children at all levels of business activity outside of the sale
the consumer must be accompanied by a written statement certifying
that the products meet the health requirements laid down in this Decree.
(3) products for children must be labelled when placed on the market of business
company or name of the manufacturer or importer and the address of the registered office, if the
on the legal person and the business name or name, surname and address of the
the place of business, if a natural person operating under the Special
the legislation.
§ 5
Products with nemetalickou finish
Nemetalická finishing of products shall not exceed the limits
referred to in annex 7.
§ 6
Products from plastic
(1) in the production of products which are intended for the care of children and that can
children placed in the mouth, it must not be used as substances or as constituents
of phthalic acid esters, as referred to in annex 6, point (I).
concentrations higher than 0.1% (by weight) in měkčeném
a polymer material.
(2) in the production of products intended for the care of children must not be used as a
substances or as constituents of preparations phthalic acid esters referred to in
Annex No 6, point (II). in concentrations higher than 0.1%
(by weight) in měkčeném a polymer material.
(3) for the manufacture of products from soft plastic must not use organostannic
stabilizers.
(4) products made of plastic, with the exception of products that are designed to
the children bring in your mouth, shall not exceed the limits of the extraction
the tests referred to in annex No. 8.
(5) plastic products, which are designed to ensure that children bring to the
the mouth, such as teats and soothers, kousátka cooling rings,
must not exceed the limits of leaching tests specified in
special legislation. ^ 4)
section 7 of the
Products made of elastomers
(1) products from elastomers, with the exception of products from elastomers that are
intended to ensure that the children bring in your mouth, shall not exceed the health
limits leaching tests referred to in annex 9.
(2) products of elastomer, which are intended to ensure that the children
do not put them into his mouth, for example, the teats and soothers, kousátka
cooling rings, shall not exceed the limits of the extraction
the tests referred to in the specific legislation. ^ 4)
§ 8
Products from textiles including non-woven fabrics
Textile products including nonwoven hygiene shall not exceed
limits leaching tests specified in annex 10.
§ 9
Products from natural leather and fur
Products from natural leather and fur must not exceed the limits
leaching tests specified in annex 11.
§ 10
Metal products
(1) metal products and metal parts of the products shall not release from the surface
nickel and its compounds in larger quantities than is provided for in a special
legislation. ^ 5)
(2) products of metals, which are inserted into pierced ears and other
parts of the human body, may contain nickel and its compounds in
the quantity provided for in a special law. ^ 6)
§ 11
The request for a derogation from the requirements laid down by this decree must contain
and the designation of the type of material) or the trade name, chemical
composition, structural formula and information about their purity (supported by
technical standard),
(b) information on the concentrations required) of the substance in the final product and justification
the technical need for its use,
(c) data on degradation) known products arising from the proposed substances
in the production, processing, ageing or emerging
as products of the interactions in these processes,
(d) individual) data on leaching ability of substances from the material, indicating the
the composition of the test material and the conditions of leaching tests
(e)) methods for the determination of proposed substances, impurities and, where appropriate,
the products of the interactions, fate, and more,
(f)) available data, foreign documentation on whether material or
the proposed substance was authorised in other Member States, in particular the
documents about the toxicity and leaching ability, the results of dermatological
the experiments, which led to the authorisation of the proposed materials or substances.
§ 12
Specific requirements for children's shoes
(1) Closed shoes size 105 feet to 165 mm may not be fully
made of synthetic materials. This does not apply if, for example,
bathing shoes and shoes dedicated single-section, produced in particular
moulding of elastomers or plastics such as boots or impermeable
winter footwear.
(2) the materials used to manufacture the upper and linings in the manufacture of footwear
the size of the foot 105 to 165 mm must have a water vapour permeability
at least 2.0 mg.cm-2 h-1.
(3) the materials used to manufacture insoles in the manufacture of footwear size
105 feet to 165 mm must have at least 35 percent of the absorption of water and
desorption of water of at least 40 percent.
(4) the different types of materials used to manufacture insoles and linings for
shoes size 105 feet to 165 mm may not exceed public health
the requirements laid down by this Decree.
Toys
section 13
Hygiene requirements for the composition of toys
(1) for the manufacture of toys listed in § 1 (1). 1 (a). and), b), c) (hereinafter referred to as
"toys") may use only the materials and finishes that
meet the hygiene requirements laid down in specific legal
^ 4).
(2) toys must not contain pathogenic and conditionally pathogenic
micro-organisms.
(3) for the manufacture of toys from plastic coated may not use organostannic
stabilizers. The coloring materials in toys and their decoration must not
use the azo dyes, which are formed by the decomposition of aromatic amines at risk
listed in annex No. 2.
(4) Toys listed in § 1 (1). 1 (a). and (c))), which are made from
soft plastic, contain not more than 0.1% (by weight)
one or more of phthalic acid esters, listed in annex 6.
(5) toys and materials from the surface must not release the dye
or optical zjasňovadla.
(6) Toys listed in § 1 (1). 1 (a). (c)) made of elastomers must
comply with the hygiene requirements for composition and testing of elastomer
category IV laid down by special law. ^ 4)
§ 14
Testing toys
(1) the Coloured materials and finishes used in the manufacture of toys, must
be resistant to the action of the test solutions modelujících saliva and sweat.
How to perform the tests of resistance of the material against the action of the sweat and saliva
is given in annex 1.
(2) the limits of leaching tests on textile materials
used in the manufacture of toys are listed in annex 12.
Common and final provisions
§ 15
For the manufacture of toys, as well as products for children shall be used natural
materials such as cork or wood nejedovatých wood,
that is without defects, bark and the ejections of resins, with the smooth
nepopraskaným surface. These materials may not show signs of
pest infestation or micro-organisms, in particular microscopic filamentous
mushrooms.
section 16 of the
To verify the sanitary requirements laid down by this Decree and its
attachments are used the method referred to in the annexes to this Decree.
If the methods are not laid down, you can use the standard methods, which
means test procedures and methods contained in the respective Czech
technical standards, which meet the requirements of accuracy and
the determination of the accuracy of the results. If the method is not currently
standardised analytical method can be used on the appropriate sensitivity
relative to the specified limit of hygiene.
§ 17
Repealed Directive of Ministry of health of the CSR-working
CZECHOSLOVAKIA on sanitary requirements for rubber and articles of rubber coming
come into contact with foodstuffs and human organism, published under no. 62/1982
in the collection of public health rules and notified in the amount of 18/1982 Coll.
section 18
This Decree shall take effect on the date of publication.
Minister:
Prof. MUDr. Fisher, PhD. in r.
Annex 1
Test of resistance of the material against the action of the sweat and saliva
1. Aids:
and) filter paper for the qualitative analysis of the medium density
b) colourless self-adhesive plastic tape with a width of 12 mm
c) desiccator
(d) the thermostat to a temperature adjustable) (40 +-2) ° C
2. Solutions:
and) composition test solution (pH = 8.8) saliva:
sodium bicarbonate NaHCO3 4.2 g
sodium chloride NaCl 0.5 g
potassium carbonate K2CO3 0.2 g
distilled water 1000 ml
(b)) the composition of the test solution (pH = 5.0) pot:
potassium chloride KCl 0.3 g
sodium chloride NaCl 4.5 g
0.3 g sodium sulphate Na2SO4
ammonium chloride NH4Cl 0.4 g
lactic acid, CH3CH (OH) COOH 3.0 g
urea NH2-CONH2 0.2 g
distilled water 1000 ml
3. The progress of the tests:
and according to the size of the sample) ustřihnou two strips of filter paper
width of 15 mm and a length of 80 mm.
A strip of filter paper soaked in a test solution
Testability verification purposes and a second bar to the test solution for Testability verification purposes.
At the same time prepare two strips of filter paper for the blind "
the test ". Depending on the nature of the product, you can use only one of the listed
Variant.
Nasáknuté strips of filter paper is attached next to each other in the
a distance of at least 10 mm on the sample, and duct tape to create a
What is the closest contact between the sample and the nasáknutými bands of filter
the paper. Adhesive tape has therefore overlap the strip of filter paper across the
length and over its edge has a project of at least 10 mm to
stick to the dry sample. ^ 1)
(b) the sample prepared as described in point) and 2) saves hours in the desiccator
over the water at a temperature of (40 +/-2) st. C. Desiccator must first be
vytemperován to the test temperature in thermostat and for the duration of the test must be in
the thermostat stay.
(c)), after two hours, the filter paper comes off from the sample and determine
whether its colouring in comparison with strips of filter paper
designated as a "blind test". If even on a single strip of paper
There are signs of coloring, the product as "resistant to the action of the
sweat "and/or" resistant to the action of saliva "depending on the nature of the product. In
otherwise, the product is marked "fragile against the action of sweat"
and/or the "fragile against the action of saliva".
Annex 2
The list of high-risk aromatic amines, which are formed by the decomposition of
azo dyes
For dyeing and printing products and toys for children must not use the
azo dyes, which are formed by the decomposition of these aromatic amines
-----------------------------------------------------------------
-4-Amino biphenyl CAS No. 67-00092-1
-Benzidine, CAS-No. 00092-87-5
-4-chloro-o-toluidine, CAS-No. 00095-69-2
-2-Naphthylamine CAS-Nr. 59-00091-8
-o-Aminoazo-toluol CAS-No. 00097-56-3
-2-Amino-4-nitro-toluol CAS-No. 00099-55-8
-p-chloro-aniline CAS No. 00106-47-8
-2.4-Diamino anisol-CAS-No. 00615-05-4
-4,4 '-Diamino-difenylmetan CAS-No. 00101-77-9
-3,3 '-Dichloro-benzidine, CAS-No. 00091-94-1
-Dimetoxy-3,3 '-benzidine, CAS-No. 00119-90-4
-3,3 '-Dimethyl-benzidine, CAS-No. 00119-93-7
3,3 '-Dimethyl-4, 4 '-diaminodifenylmetan CAS-No. 00838-88-0
-p-Keresidin CAS-Nr. 00120-71-8
-4,4 '-Metylen-bis (2-chloroaniline) CAS-No. 00101-14-4
-4.4 ' Oxy-dianiline CAS-No. 00101-80-4
-4,4 '-Thio-dianiline CAS-No. 00139-65-1
-o-Toluidine, CAS-No. 00095-53-4
-2.4-Toluylendiamin CAS-No. 00095-80-7
-2,4, 5-Trimetyl-aniline CAS No. 00137-17-7
-4-Aminoazobenzen CAS-No. 00060-09-3
-o-Anisidin CAS-No. 04-00090-0
-----------------------------------------------------------------
CAS-Chemical Abstract Service
Annex 3
List of banned dyes
---------------------------------
Under the name C.I. the number of the C.I.
---------------------------------
Solvent Yellow 1
Solvent Yellow 2 11020
Solvent Yellow 3 11160
Basic Red 9
Disperse Blue 1
Acid Red 26
---------------------------------
Annex 4
Requirements for the purity of the dyes and pigments used for dyeing and printing
non-woven fabrics, including in the manufacture of products for children
1. the Dyes used for dyeing and printing of textiles and non-woven fabrics
used in the manufacture of products for children may contain no more than the following
content of metals in ionic form: As 50 mg/kg, 20 mg/kg Cd, Cr 100 mg/kg, Cu
250 mg/kg Hg 4 mg/kg, 200 mg/kg 100 mg/kg Pb, Sb 250 mg/kg Zn
1500 mg/kg.
2. Pigments used for dyeing and printing of textiles and non-woven
fabrics used in the manufacture of products for children may include no more than
the following content of metals in ionic form: As 50 mg/kg, 50 mg/kg Cd, Cr
100 mg/kg Hg 25 mg/kg 100 mg/kg Pb, Sb 250 mg/kg Zn 1000 mg/kg.
Annex 5
Requirements for cleanliness of carbon black
1. The Absorbance of the filtrate of 1.0 g of soot in suspension 100 ml
distilled after twenty four hour extraction in cyclohexane
temperature (20-22) St. (C) measured in a sample of length 5 cm wavelength
385 nm may not be greater than 0.1.
2. Toluenový extract prepared an eight-hour extraction 10 g of soot in the
Soxhlet extractor must not be greater than 0.15 percent.
Annex 6
List of phthalic acid esters
(I).
di-' isononyl ' phthalate (DINP) CAS No 28553-.-12-0, Einecs-No. 249-079-5,
di-n-octyl phthalate (DNOP) CAS No 117-84-0 Einecs No 204-214-7,-
di-iso-decyl phthalate (DIDP) CAS No 26761-.-40-0 Einecs-No. 247-977-1
II.
Butyl benzyl phthalate (BBP) CAS No 85-68-7 Einecs No 201-622-7-
dibutyl phthalate (DBP) CAS No 84-74-2 Einecs No 201-557-4-
di (2-ethylhexyl) phthalate (DEHP) CAS No 117-81-7 Einecs No 204-211-0-
CAS-Chemical Abstract Service.
Annex 7
Limits leaching tests of surface nemetalických
editing products for children
(1) the quantity of the chemical substances specified in the extracts from the surface
nemetalických editing products for children, prepared by the
distilled water, 1 cm2:1 ml, for a period of 24 hours, at a temperature of 40 ° C,
must not exceed the following limits:
phenolic compounds 0.05 mg fenolu.dm-2
compounds with-NH2 group of 0.05 mg NH2.dm-2
primary aromatic amines anilinhydrochloridu 0.005 mg/dm2
formaldehyde 0.10 mg.dm-2
aromatic compounds expressed as styrene 0.10 mg dm-2
phthalic acid esters on the maximum 0.20 mg.dm-2
(2) the migration of antimony, arsenic, barium, cadmium, chromium, lead, mercury and
Selenium from surface water in nemetalických acid solution
c hydrochloric (HCl) = 0.07 mol/l, for 2 hours, when
temperature (37 +/-2) ° C, must not exceed the following limits:
+-------+---------------+
| Antimony | max. 60 mg/kg |
+-------+---------------+
| Arsenic | max. 25 mg/kg |
+-------+---------------+
| Barium | max. 1000 mg/kg |
+-------+---------------+
| Cadmium | max. 75 mg/kg |
+-------+---------------+
| Chromium | max. 60 mg/kg |
+-------+---------------+
| Lead | max. the 90 mg/kg |
+-------+---------------+
| Mercury | max. 60 mg/kg |
+-------+---------------+
| Selenium | max. 500 mg/kg |
+-------+---------------+
Annex 8
Limits leaching tests of plastics used for products
for children
1. Plastic must comply with the overall migration limit of not more than 10 mg/dm2, when
extraction of 1 dm2 total area of plastic in 100 ml of distilled water,
temperature (37 +-2) ° C for 24 hours.
2. Contents of monomérního vinyl chloride shall not exceed the limit of 1 mg/kg
the product.
3. Content of primary aromatic amines in solution in distilled water
prepared in accordance with point 1 of polyurethane products shall not exceed the limit
0.05 mg/l anilinhydrochloridu. In the case of foam material, vyluhují
2 g material in 100 ml of distilled water, at a temperature (37 +-2) ° C
for a period of 24 hours.
4. The content of the risk elements in extracts of modelujících acid and alkali
the pot must not exceed the following limits per weight
product: ^ 1)
+---------------------------+-----------------+
| Arsenic | max. 0.2 mg/kg |
+---------------------------+-----------------+
| Lead | max. 0.2 mg/kg |
+---------------------------+-----------------+
| Cadmium | max. 0.1 mg/kg |
+---------------------------+-----------------+
| Mercury | max. 0.02 mg/kg |
+---------------------------+-----------------+
| Total vyluhovatelný chromium | max. 1.00 mg/kg |
+---------------------------+-----------------+
| Chromium hexavalent | an undetectable nuclear ^ 2) |
+---------------------------+-----------------+
| Cobalt | max. 1.00 mg/kg |
+---------------------------+-----------------+
| Copper | max. 25.00 mg/kg |
+---------------------------+-----------------+
| Nickel | max. 1.00 mg/kg |
+---------------------------+-----------------+
5. For the determination of the values referred to in point 4, the vyluhují 2 g in 100 ml plastic
solutions of modelujících acid and alkali pot, whose composition is indicated
in point 6. and, at 7 (37 +-2) ° C for 4 hours.
6. alkaline solution of medium pot must be freshly prepared, one
litre of solution contains:
0.5 g monohydrate L-histidinmonohydrochloridu-C6H9O2N3. URHCl.H2O
5.0 g of sodium chloride-NaCl
5.0 g of dodecahydrate disodium disodného
-Na2HPO 4.12 H2O
the pH of the solution is adjusted to a value of 8 with sodium hydroxide solution-
NaOH concentration of 0.1 mol/l
7. modeling the solution acidic sweat must be freshly prepared, one litre
the solution includes:
0.5 g monohydrate L-histidinmonohydrochloridu-C6H9O2N3. URHCl.H2O
5.0 g of sodium chloride-NaCl
sodium dihydrogen phosphate dihydrate 2.2 g-NaH2PO 4.2 H2O
the pH of the solution is adjusted to the value of 5.5 with sodium hydroxide solution
-NaOH concentration of 0.1 mol/l
8. Migration of antimony, arsenic, barium, cadmium, chromium, lead, mercury and
Selenium from the plastic into the water of the hydrochloric acid solution
the concentration c (HCl) = 0.07 mol/l for a period of 2 hours at a temperature of (37 +/-
2) ° C, must not exceed the following limits:
+-------+---------------+
| Antimony | max. 60 mg/kg |
+-------+---------------+
| Arsenic | max. 25 mg/kg |
+-------+---------------+
| Barium | max. 1000 mg/kg |
+-------+---------------+
| Cadmium | max. 75 mg/kg |
+-------+---------------+
| Chromium | max. 60 mg/kg |
+-------+---------------+
| Lead | max. the 90 mg/kg |
+-------+---------------+
| Mercury | max. 60 mg/kg |
+-------+---------------+
| Selenium | max. 500 mg/kg |
+-------+---------------+
Annex 9
Limits leaching tests of the elastomers used for
products for children
1. Extract from the elastomer prepared by 8 g elastomer to 100 ml
distilled water, at a temperature (37 +/-2) ° C, for a period of 24 hours shall
meet the following requirements
The content of reducing substances up to 30 ml of the 0.002 mol/l KMnO4/50 ml
+
Evidence of not more than 2 mg of ammonium ion NH4/kg
The contents of the primary
not more than 0.05 mg aromatic amines anilinhydrochloridu/l.
2. Elastomeric must comply with the overall migration limit of not more than 10 mg/dm2, when
extraction of 1 dm2 total area of elastomer in 100 ml of distilled water,
When the temperature (37 +-2) ° C for 24 hours.
3. the content of substances in solution of oxidizable silicone elastomer
prepared by 8 g elastomer in 100 ml of distilled water,
temperature (37 +/-2) ° C, for a period of 24 hours, must comply with the maximum limit
0.5 mg/100 ml of KMnO4.
4. The content of the risk elements in extracts of modelujících acid and alkali
the pot must not exceed the following limits per weight
product: ^ 1)
+---------------------------+-----------------+
| Arsenic | Max. 0.2 mg/kg |
+---------------------------+-----------------+
| Lead | Max. 0.2 mg/kg |
+---------------------------+-----------------+
| Cadmium | Max. 0.1 mg/kg |
+---------------------------+-----------------+
| Mercury | Max. 0.02 mg/kg |
+---------------------------+-----------------+
| Total vyluhovatelný chrome | Max. 1.00 mg/kg |
+---------------------------+-----------------+
| Chrome hexavalent | An undetectable nuclear ^ 2) |
+---------------------------+-----------------+
| Cobalt | Max. 1.00 mg/kg |
+---------------------------+-----------------+
| Měď | Max. 25.00 mg/kg |
+---------------------------+-----------------+
| Nickel | Max. 1.00 mg/kg |
+---------------------------+-----------------+
5. For the determination of the values referred to in paragraph 1 shall be carried out after the following extract
preparation of samples: the test sample shall be divided into pieces of 4 cm2, or
pieces weighing approximately 0.5 g. sample quantity to Cook 20
minutes with 120 ml of distilled water. The water is still hot and decant the sample
shake three times in 100 ml of distilled water always 60 seconds. Cleaning backwash
the water is emptied after each washings.
6. For the determination of the values referred to in point 4, the vyluhují 2 g elastomer to 100
ml solutions of modelujících acid and alkali pot, whose composition is
referred to in point 7 and 8, at a temperature (37 +-2) ° C for 4 hours.
7. modeling Solution alkaline sweat must be freshly prepared, one
litre of solution contains:
0.5 g monohydrate L-histidinmonohydrochloridu-C6H9O2N3. URHCl.H2O
5.0 g of sodium chloride-NaCl
5.0 g of dodecahydrate disodium disodného
-Na2HPO 4.12 H2O
the pH of the solution is adjusted to a value of 8 with sodium hydroxide solution-
NaOH concentration of 0.1 mol/l
8. modeling the solution acidic sweat must be freshly prepared, one litre
the solution includes:
0.5 g monohydrate L-histidinmonohydrochloridu-C6H9O2N3. URHCl.H2O
5.0 g of sodium chloride-NaCl
sodium dihydrogen phosphate dihydrate 2.2 g-NaH2PO 4.2 H2O
the pH of the solution is adjusted to the value of 5.5 with sodium hydroxide solution
-NaOH concentration of 0.1 mol/l
9. Migration of antimony, arsenic, barium, cadmium, chromium, lead, mercury and
Selenium of elastomer in water solution of hydrochloric acid on the
the concentration c (HCl) = 0.07 mol/l for a period of 2 hours at a temperature of (37 +/-
2) ° C, must not exceed the following limits:
+-------+---------------+
| Antimony | max. 60 mg/kg |
+-------+---------------+
| Arsenic | max. 25 mg/kg |
+-------+---------------+
| Barium | max. 1000 mg/kg |
+-------+---------------+
| Cadmium | max. 75 mg/kg |
+-------+---------------+
| Chromium | max. 60 mg/kg |
+-------+---------------+
| Lead | max. the 90 mg/kg |
+-------+---------------+
| Mercury | max. 60 mg/kg |
+-------+---------------+
| Selenium | max. 500 mg/kg |
+-------+---------------+
Annex 10
Limits leaching tests of textiles and non-woven fabrics
used for products for children
1. the content free and hydrolysable formaldehyde in solution
prepared by 2.5 g of fabrics or non-woven fabrics in 100 ml
distilled water for 1 hour at a temperature of (40 +/-2) ° C may not
exceed 30.0 mg in 1 kg of material.
2. The pH of the extract obtained by shaking the 2 g fabrics or non-woven fabric
fabrics in 100 ml of distilled water for a period of 2 hours at a temperature of (20 +/-
2) ° C shall not exceed the limit of 4.0-7.5.
3. To change the colour fastness of dyed fabrics or non-woven fabrics
must comply with the subsequent stages of the grey scale colour fastness:
color fastness in sweat 3-4
color fastness in dry abrasion 4
wet fastness wear 2-3
He admits to perform repeated authentication changes colour fastness after washing
material provided: the wash temperature according to the symbol for the treatment
indicated on the product label. The test shall be carried out according to the ČSN EN ISO 20105
(C01-C09, in justified cases, C06). In the case of acquisition
satisfactory results in repeated tests verifying the change
colour fastness product must be marked in the manner referred to in section 4, paragraph 4.
1.
4. Content of primary aromatic amines specified in the extract in
distilled water from textile fabrics or non-woven fabrics ready in accordance with point
1 shall not exceed the limit of 0.05 mg/l anilinhydrochloridu.
5. The contents of the risk elements in extracts of modelujících acid and alkali
the pot must not exceed the following limits related to the weight of the product:
+---------------------------+-----------------+
| Arsenic | Max. 0.2 mg/kg |
+---------------------------+-----------------+
| Lead | Max. 0.2 mg/kg |
+---------------------------+-----------------+
| Cadmium | Max. 0.1 mg/kg |
+---------------------------+-----------------+
| Mercury | Max. 0.02 mg/kg |
+---------------------------+-----------------+
| Total vyluhovatelný chrome | Max. 1.00 mg/kg |
+---------------------------+-----------------+
| Chrome hexavalent | An undetectable nuclear ^ 1) |
+---------------------------+-----------------+
| Cobalt | Max. 1.00 mg/kg |
+---------------------------+-----------------+
| Měď | Max. 25.00 mg/kg |
+---------------------------+-----------------+
| Nickel | Max. 1.00 mg/kg |
+---------------------------+-----------------+
6. For the determination of the values referred to in point 5, the vyluhují 2 g fabric or
non-woven fabrics in 100 ml solutions of modelujících acid and alkaline sweat
whose composition is indicated in point 7 and 8, at a temperature (37 +-2) ° C
After 4 hours.
7. modeling Solution alkaline sweat must be freshly prepared, one
litre of solution contains:
0.5 g monohydrate L-histidinmonohydrochloridu-C6H9O2N3. URHCl.H2O
5.0 g of sodium chloride-NaCl
5.0 g of dodecahydrate disodium disodného
-Na2HPO 4.12 H2O
the pH of the solution is adjusted to a value of 8 with sodium hydroxide solution
-NaOH concentration of 0.1 mol/l
8. modeling the solution acidic sweat must be freshly prepared, one litre
the solution includes:
0.5 g monohydrate L-histidinmonohydrochloridu-C6H9O2N3. URHCl.H2O
5.0 g of sodium chloride-NaCl
sodium dihydrogen phosphate dihydrate 2.2 g-NaH2PO 4.2
H2O
the pH of the solution is adjusted to the value of 5.5 with sodium hydroxide solution
-NaOH concentration of 0.1 mol/l
Annex 11
Limits leaching tests of natural leather and fur
used for products for children
1. the content free and hydrolysable formaldehyde in solution
prepared by 2.5 g natural leather or fur in 100 ml
distilled water for 1 hour at a temperature of (40 +/-2) ° C may not
exceed 30.0 mg in 1 kg of material.
2. The pH of the extract obtained by shaking 5 g powdered natural leather
or fur in 100 ml of distilled water for 6 hours at a temperature of
(20 +-2) ° C shall not exceed the limit of 3.5-8.5.
3. To change the colour fastness of dyed natural leather or fur must
comply with the subsequent stages of the grey scale colour fastness:
color fastness in dry abrasion 4
fastness to wet abrasion resistance 3
4. The total content of vyluhovatelného chromium (Cr) from natural leather or
fur (spliced) in the extract, prepared by a sample of the
the total area of 140 cm to 100 ml of distilled water for a period of 72 hours may not
exceed the limit of 50 mg in 1 kg of material.
5. vyluhovatelného content of hexavalent chromium (Cr6 +) in solution
prepared in accordance with paragraph 2 must be below the detection limit of the method-0.1
mg Cr6 +/kg.
6. Content of primary aromatic amines specified in the extract in
distilled water from natural leather prepared in accordance with paragraph 1 shall not
should not exceed 0.05 mg/l anilinhydrochloridu.
7. The contents of the risk elements in extracts of modelujících acid and alkali
the pot must not exceed the following limits related to the weight of the product:
+---------------------------+-----------------+
| Arsenic | Max. 0.2 mg/kg |
+---------------------------+-----------------+
| Lead | Max. 0.2 mg/kg |
+---------------------------+-----------------+
| Cadmium | Max. 0.1 mg/kg |
+---------------------------+-----------------+
| Mercury | Max. 0.02 mg/kg |
+---------------------------+-----------------+
| Cobalt | Max. 1.00 mg/kg |
+---------------------------+-----------------+
| Měď | Max. 25.00 mg/kg |
+---------------------------+-----------------+
| Nickel | Max. 1.00 mg/kg |
+---------------------------+-----------------+
8. For the determination of the values referred to in point 7, the vyluhují 2 g natural leather to
100 ml solutions of modelujících acid and alkali pot, whose composition is
indicated in point 9 and 10 at a temperature of (37 +-2) ° C for 4 hours.
9. Solution of alkaline medium pot must be freshly prepared, one
litre of solution contains:
0.5 g monohydrate L-histidinmonohydrochloridu-C6H9O2N3. URHCl.H2O
5.0 g of sodium chloride-NaCl
5.0 g of dodecahydrate disodium disodného
-Na2HPO 4.12 H2O
the pH of the solution is adjusted to a value of 8 with sodium hydroxide solution-
NaOH concentration of 0.1 mol/l
10. modeling the solution acidic sweat must be freshly prepared, one
litre of solution contains:
0.5 g monohydrate L-histidinmonohydrochloridu-C6H9O2N3. URHCl.H2O
5.0 g of sodium chloride-NaCl
sodium dihydrogen phosphate dihydrate 2.2 g-NaH2PO 4.2 H2O
the pH of the solution is adjusted to the value of 5.5 with sodium hydroxide solution
-NaOH concentration of 0.1 mol/l
Annex 12
Limits leaching tests on textile materials used
in the manufacture of toys
The quantity of the chemical substances specified in the extracts from the textile
materials prepared by toys in distilled water for 1
hours, at a temperature of (40 +-2) ° C, 2 g: 100 ml, shall not exceed
the following limits:
free hydrolyzovatelný formaldehyde 30.00 mg/kg
primary aromatic amines anilinhydrochloridu 0.05 mg/l
Selected provisions of the novel
Article II of the Decree No 521/2005 Sb.
The transitional provisions of the
The provisions of this Ordinance shall not apply to products which are intended for
for children under the age of 3 years, and which have been placed on the market before the date of entry into
the effectiveness of this Ordinance.
1) Law No. 22/1997 Coll., on technical requirements for products and amending
and additions to certain laws, as amended by law No 71/2000 Coll., Regulation
Government no 171/1997 Coll., laying down technical requirements for toys,
as amended by regulation of the Government No. 292/2000 Sb.
1) if the product is too large, the test is only part of it. If there is a
product small, whole product to wrap the filter paper.
1) test is performed only on the plastic materials used in the manufacture of
footwear and clothing.
1) Test shall be carried out only in the elastomers used in the production of shoes and
clothing.
1) limit of determination is 0.5 mg of Cr6 +/kg.
2) Law No. 157/1998 Coll., on chemical substances and chemical preparations
and amending certain other acts, as amended by Act No. 349/1999 Coll.
2) limit of determination is 0.5 mg of Cr6 +/kg.
2) limit of determination is 0.5 mg of Cr6 +/kg.
3) Decree No. 26/2001 Coll. on hygienic requirements for cosmetic
resources about the terms of the request for the omission of the ingredients on the packaging
a cosmetic product and about the requirements for education and the practice of physical
the person responsible for the manufacture of the cosmetic product (the Decree on the
cosmetic products).
4) Decree No. 38/2001 Coll. on hygienic requirements for products
intended to come into contact with foodstuffs and dishes.
5) point 28 sub-items 2 and 3 of the annex to Decree No. 301/1998 Coll., which
provides a list of chemical substances and chemical preparations, the production of which,
the placing on the market and the use is limited.
6) point 28 sub-item 1 of the annex to Decree No. 301/1998 Coll.
