On The Hygiene Requirements On Toys And Products For Children Under 3 Years

Original Language Title: o hygienických požadavcích na hračky a výrobky pro děti do 3 let

Read the untranslated law here: https://portal.gov.cz/app/zakony/download?idBiblio=51082&nr=84~2F2001~20Sb.&ft=txt

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.