Government Decree No. 315 / 2009 Coll.
Government Regulation amending Government Decree No. 194 / 2001 Coll., laying down technical requirements for aerosol dispensers, as amended by Government Decree No. 305 / 2006 Coll.
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Regulation
Effective from 29.04.2010
Text versions:
29.04.2010
11.09.2009
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315
GOVERNMENT REGULATION
of 17 August 2009
amending Government Regulation No 194 / 2001 Coll., laying down technical requirements for aerosol dispensers, as amended by Government Regulation No 305 / 2006 Coll.
The Government orders pursuant to Section 22 of Act No. 22 / 1997 Coll., on Technical Requirements for Products and on the Amendment and Addition of Certain Acts, as amended by Act No. 71 / 2000 Coll. and Act No. 205 / 2002 Coll., ("the Act ') to implement Sections 12 (1) and (3) and 13 (2) of the Act:
Government Regulation No 194 / 2001 Coll., laying down technical requirements for aerosol dispensers, as amended by Government Regulation No 305 / 2006 Coll., is amended as follows:
1. footnote 1 shall read:
"(1) Council Directive 75 / 324 / EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers, as amended by Commission Directive 94 / 1 / EC and Commission Directive 2008 / 47 / EC."
2. In Article 3, "§ 12 (4) (a) 'is replaced by" § 12 (3) (a)';
3. In Article 6 (1), "Manufacturer, importer or distributor 'is replaced by" Manufacturer or importer';
4. footnote 3 shall read:
"(3) For example, Act No 356 / 2003 Coll., on Chemicals and Chemicals and amending certain laws, as amended, Decree No 26 / 2001 Coll., on sanitary requirements for cosmetic products, on the particulars of the application for the non-inclusion of ingredients on the packaging of cosmetic products and on the requirements for the education and practice of a natural person responsible for the manufacture of cosmetic products (cosmetic products decree), as amended."
5. Paragraph 6 (4) reads as follows:
"(4) Where an aerosol dispenser contains flammable constituents as referred to in point 1.4.8 of Annex 1 to this Regulation and is not considered to be" flammable 'or "extremely flammable' as referred to in point 1.4.9 of Annex 1 to this Regulation, the amount of flammable material contained in the aerosol dispenser shall be indicated on the label legibly and indelibly in the following wording:" X% of the filling mass is flammable '.
6. Annex 1 shall read as follows:
"Annex No. 1 to Government Decree No. 194 / 2001 Coll.
ESSENTIAL REQUIREMENTS FOR AEROSOLUTES
1. GENERAL REQUIREMENTS
Without prejudice to the specific provisions of this Annex relating to the requirements relating to flammable and to the risk arising from the application of pressure, the aerosol dispenser shall be designed, constructed and tested with regard to the requirements resulting from the analysis carried out by the manufacturer or importer in order to consider the risk arising from the inhalation of spray by an aerosol dispenser under normal or reasonably foreseeable conditions of use, taking into account the distribution of aerosol particle size along with the physical and chemical properties of the filling, where appropriate specific data relating to the use of the aerosol dispenser shall be specified.
1.1 Design and equipment of aerosol dispenser
1.1.1 The aerosol dispenser shall be so designed as to comply with the provisions of this Annex under normal conditions of use and storage.
1.1.2. The closure shall allow for the airlock of the aerosol dispenser under normal storage or transport conditions and shall be protected, for example by a protective cover, against unintentional opening and any damage.
1.1.3 The substances contained in the aerosol dispenser shall not reduce the mechanical resistance of the aerosol dispenser even in long-term storage.
1.2 Label on aerosol dispensers
Without prejudice to the provisions relating to the classification, packaging and labelling of dangerous substances and preparations, in particular as regards the risk of damage to health or the environment, the following particulars shall appear visibly, legibly and indelibly on each aerosol dispenser:
(a) "The container is under pressure: do not expose to sunlight and temperatures above 50 ° C. Do not break through the emptied container, nor throw into the fire."
(b) when aerosol is classified as "flammable" or "extremely flammable" on the basis of the criteria set out in point 1.4.9;
- the flame symbol in accordance with the model set out in Annex 4 to Decree No. 232 / 2004 Coll., implementing certain provisions of the Act on Chemicals and Chemical Products and amending certain acts concerning the classification, packaging and labelling of dangerous chemicals and chemical preparations, as amended,
- a warning "flammable" or "extremely flammable," depending on the classification of the dispenser as "flammable" or "extremely flammable."
1.3.
Without prejudice to the provisions relating to the classification, packaging and labelling of dangerous substances and preparations, in particular as regards the risk of damage to health or the environment, the following particulars shall appear visibly, legibly and indelibly on each aerosol dispenser:
(a) any additional instructions for use which alert the consumer to a particular product hazard; where separate instructions for use are attached to the aerosol dispenser, such instructions for use shall be provided;
(b) if the aerosol is classified as "flammable" or "extremely flammable" on the basis of the criteria set out in point 1.4.9, the following warnings:
- the Safe Treatment Guidelines S2 and S16 referred to in point 6.2 of Annex 2 to Decree No. 232 / 2004 Coll., implementing certain provisions of the Act on Chemicals and Chemical Products and amending certain acts concerning the classification, packaging and labelling of dangerous chemicals and chemical preparations, as amended,
- "Do not spray into open fire or hot objects."
1.4 Definition of terms
For the purposes of this Regulation:
1.4.1. Overpressure internal overpressure in the filled aerosol dispenser, expressed in megapascals (MPa).
1.4.2. The test excess pressure which can be applied to the internal walls of an empty aerosol dispenser for 25 seconds without leakage or, in the case of metal or plastic containers, visible or permanent deformation, except for the permitted deformation according to point 1.1.2 of Annex 2 to this Regulation.
1.4.3 A destructive overpressure is the lowest pressure that causes rupture or rupture in the aerosol dispenser container.
1.4.4 The actual volume of unclosed aerosol dispensers up to its upper edge, expressed in millilitres.
1.4.5. Useful volume volume filled with sealed aerosol dispensers, expressed in millilitres.
1.4.6 By volume, the volume of phases other than gaseous in the closed container of the aerosol dispenser.
1.4.7 Test conditions of the test and destructive overpressure applied hydraulically at (20 ± 5) ° C.
1.4.8. Flammable filling
The charges of aerosols shall be considered flammable if they contain any component classified as flammable, provided that:
(a) flammable liquid means liquid with a flash point not more than 93 ° C;
(b) flammable solid means a solid or mixture which is easily ignited or may cause or contribute to an ignition due to friction. Readily ignited solids are substances or mixtures in the form of powder, granules or pastes which are dangerous if they can easily ignite in short contact with a source of ignition, such as a burning match, and if the flame spreads rapidly,
(c) flammable gas means a gas or gas mixture with an air ignition limit at 20 ° C and a standard pressure of 101,3 kPa.
The definition according to the first sentence does not include pyrophoric, self-heating substances or mixtures or mixtures which react with water. These substances or mixtures which react with water shall never be components of aerosols.
1.4.9 Flammable aerosols
For the purposes of this Regulation, aerosol shall be considered as "non-flammable '," flammable' or "extremely flammable 'according to its chemical combustion heat and the mass content of the flammable components as follows:
(a) aerosol is classified as "extremely flammable" if it contains 85% or more of flammable constituents and the chemical combustion heat is greater than or equal to 30 kJ / g;
(b) aerosol is classified as "non-flammable" if it contains 1% or less flammable constituents and the chemical heat of combustion is less than 20 kJ / g;
(c) all other aerosols shall be subjected to the following procedure for classification of flammable substances or shall be classified as "extremely flammable." The test for the determination of the flash distance, the flash test in the enclosed space and the foam burning test shall be in accordance with point 3 of Annex 2 to this Regulation.
1.4.9.1 Spray flammable aerosols
In the case of spray aerosols, the classification shall be carried out taking into account the chemical combustion heat and based on the results of the flash distance test as follows:
(a) if the chemical combustion heat is less than 20 kJ / g,
(i) aerosol is classified as "flammable" if an ignition occurs at a distance equal to or greater than 15 cm but less than 75 cm;
(ii) aerosol shall be classified as "extremely flammable" if ignition occurs at a distance of 75 cm or more;
(iii) if the ignition does not occur during the ignition distance test, the enclosed flash test in the enclosed space shall be carried out and in this case the aerosol shall be classified as "flammable" if the time equivalent is less than or equal to 300 s / m3 or if the specific mass of deflagration is less than or equal to 300 g / m3; otherwise the aerosol shall be classified as "non-flammable,"
(b) if the chemical combustion heat is equal to or greater than 20 kJ / g, the aerosol shall be classified as "extremely flammable" if it occurs at a distance of 75 cm or more; Otherwise, aerosol is classified as "flammable '.
1.4.9.2 Flammable foam aerosols
In the case of foam aerosols, the classification shall be based on the results of the foam flammable test.
(a) the aerosol product shall be classified as "extremely flammable" if:
(i) the flame height is 20 cm or more and the flame burning time is 2 s or longer;
or
(ii) the flame height is 4 cm or more and the flame burning time is 7 s or longer.
(b) An aerosol product which does not comply with the criteria in (a) shall be classified as "flammable" if the flame height is 4 cm or more and the flame burning time is 2 s or longer.
1.4.10 Chemical combustion heat
The chemical heat of combustion ΔHc shall be determined either
(a) recognised technological rules, as described, for example, in standards such as ASTM D 240, ISO 13943 86.1 to 86.3 and NFPA 30B, or contained in established scientific literature;
or
(b) using this method of calculation
Chemical combustion heat (ΔHc) in kilojoules per gram (kJ / g) can be calculated as the product of theoretical combustion heat (ΔHcomb) and combustion efficiency, usually less than 1,0 (typical combustion efficiency is 0,95 or 95%).
For composite aerosols, chemical combustion heat is the sum of the weighted combustion heat of the individual components:
IUPAC Name
where:
ΔHc = chemical combustion heat (kJ / g) of the product,
wi% = the fraction by weight of the ith component in the product,
ΔHc (i) = specific combustion heat (kJ / g) of the ith component in the product.
The manufacturer or importer shall describe the method used to determine the chemical combustion heat in a document drawn up in the official language of the European Communities and readily available at the address indicated on the label in accordance with Article 6 (1) (a), when the chemical combustion heat is used as a parameter for the determination of the flammable properties of aerosols in accordance with the provisions of this Regulation.
1.5. Liquid phase volume
The volume of the liquid phase at 50 ° C shall not exceed 90 per cent of the useful volume of the container.
2. SPECIFIC REQUIREMENTS FOR AEROSOL METALS
2.1. Volume
The actual volume of these containers shall not exceed 1000 ml.
2.1.1 Test pressure of container
(a) In the case of containers filled with excess pressure of less than 0,67 MPa at 50 ° C, the test pressure shall be at least 1 MPa.
(b) For containers filled with an excess pressure equal to or greater than 0,67 MPa at 50 ° C, the test excess pressure shall be 50% higher than the internal excess pressure at 50 ° C.
2.1.2. Implementation
At 50 ° C, the excess pressure in the aerosol dispenser shall not exceed 1,2 MPa. However, if aerosol does not contain gas or a mixture of gases with an air ignition limit at 20 ° C and a standard pressure of 101,3 kPa, the maximum permitted pressure at 50 ° C shall be 1,32 MPa.
3. SPECIFIC REQUIREMENTS FOR AEROSOL SOLUTION DEPARTMENTS WITH VARIUM
3.1. Containers of plastic coated glass or permanently protected containers
This type of container can be used for filling with compressed, liquefied or dissolved gas.
3.1.1 Volume
The actual volume of these containers shall not exceed 220 billion.
3.1.2. Coating
The coating consists of a protective layer of plastic or other suitable material to prevent the risk of glass shrapnel being polished when the container is accidentally broken. The containers shall be so designed that glass shrapnel does not fly when the filled aerosol dispenser falls to 20 ° C from a height of 1,8 m on the concrete floor.
3.1.3 Test pressure of container
(a) Containers intended for filling with compressed or dissolved gas shall withstand a test pressure equal to or greater than 1,2 MPa.
(b) Containers intended to be filled with liquefied gas shall withstand a test pressure equal to or greater than 1 MPa.
3.1.4. Implementation
(a) Aerosol dispensers filled with compressed gas shall not be subjected to more than 0,9 MPa at 50 ° C.
(b) Aerosol dispensers filled with dissolved gas shall not be subjected to more than 0,8 MPa at 50 ° C.
(c) Aerosol dispensers containing liquefied gas or a mixture of liquefied gases shall not be subjected at 20 ° C to an excess pressure higher than that specified in Table 1.
Table 1: Limits for excess pressure at 20 ° C depending on gas content (in% w / w)
| skutečný objem nádobky aerosolového rozprašovače (ml) | obsah zkapalněného plynu v celkové směsi (v % hmot.) | ||
|---|---|---|---|
| 20 % | 50 % | 80 % | |
| 50 < x <= 80 | 0,35 MPa | 0,28 MPa | 0,25 MPa |
| 50 < x <= 160 | 0,32 MPa | 0,25 MPa | 0,22 MPa |
| 160 < x <= 220 | 0,28 MPa | 0,21 MPa | 0,18 MPa |
The excess pressure limits for gas content values not specified in the table shall be obtained by extrapolating the values specified in the table.
3.2 Unprotected glass containers
Unprotected glass containers shall be filled with only liquefied or dissolved gases.
3.2.1 Volume
The actual volume of these containers shall not exceed 150 ml.
3.2.2 Test pressure of the container
The test pressure of the container shall be at least 1,2 MPa.
3.2.3. Implementation
(a) Containers filled with dissolved gas shall not be subjected to an excess pressure exceeding 0,8 MPa at 50 ° C.
(b) Containers containing liquefied gas shall not be subjected at 20 ° C to an excess pressure higher than that specified in Table 2.
Table 2: Limits for excess pressure at 20 ° C depending on gas content (in% w / w)
| skutečný objem nádobky aerosolového rozprašovače (ml) | obsah zkapalněného plynu v celkové směsi (v % hmot.) | ||
|---|---|---|---|
| 20 % | 50 % | 80 % | |
| 50 < x <= 70 | 0,15 MPa | 0,15 MPa | 0,125 MPa |
| 70 < x <= 150 | 0,15 MPa | 0,15 MPa | 0,1 MPa |
The excess pressure limits for gas content values not specified in the table shall be obtained by extrapolating the values specified in the table.
4. SPECIFIC REQUIREMENTS FOR AEROSOL SOLUTION DEPARTMENTS WITH PLASTIC COLLECTION
4.1 Aerosol dispensers with plastic containers that may form shrapnel during rupture are considered equivalent to aerosol dispensers with unprotected glass containers.
4.2 Aerosol dispensers with plastic containers which cannot produce shrapnel in the event of rupture shall be considered equivalent to aerosol dispensers with plastic coated glass containers. ';
7. Annex 2 shall read as follows:
"Annex No 2 to Decree No. 194 / 2001 Coll.
PROCEDURE FOR CONFORMITY OF AEROSOLUTION DEPARTMENTS
1. Tests provided by the manufacturer or importer
1.1 Hydraulic test of empty containers
1.1.1. Containers of metal, glass or plastics shall withstand the hydraulic pressure test referred to in paragraphs 2.1.1, 3.1.3 and 3.2.2. of Annex 1 to this Regulation.
1.1.2 Metal containers showing asymmetrical or significant deformations or other similar defects shall be discarded. A slight symmetrical deformation of the bottom or deformation of the upper part profile is permitted provided that the container complies with the destructive test.
1.2 Destruction test of empty metal containers
The manufacturer or importer shall ensure that the destructive excess pressure of containers is at least 20% higher than the specified test pressure.
1.3. Free fall test for coated glass containers
The manufacturer or importer shall ensure that the containers comply with the test requirements set out in point 3.1.2 of Annex 1 to this Regulation.
1.4 Final check of filled aerosol dispensers
1.4.1 The aerosol dispensers shall be subjected to one of the following final test methods:
a) Hot water bath test
Each filled aerosol dispenser is immersed in a hot water bath.
i) The temperature of the water bath and the time of the test shall be chosen so that the internal pressure reaches the pressure which its filling has at a uniform temperature of 50 ° C.
(ii) Any aerosol dispenser showing visible permanent deformation or leakage shall be discarded.
(b) Hot methods of final testing
Other methods may be used to heat the filling of aerosol dispensers, provided that such methods ensure that the pressure and temperature in each filled aerosol dispenser achieve the values required for the hot water bath test and the deformation and leakage test are found with the same accuracy as in the hot water bath test.
(c) Cold methods of final examination
The alternative cold final test method may be used if it complies with the provisions on the test method alternative to the hot water bath test method for aerosol dispensers referred to in point 6.2.4.3.2.2 of Annex A to Council Directive 94 / 55 / EC on the approximation of the laws of the Member States relating to the transport of dangerous goods by road.
1.4.2. For aerosol dispensers whose charges undergo physical or chemical transformation, changing their pressure characteristics after filling and before first use, cold methods of the final test referred to in point 1.4.1 (c) should be used.
1.4.3. For test methods according to points 1.4.1 (b) and (c):
(a) The test method shall be approved by the competent authority or, where appropriate, by the body empowered by it, which is the competent authority under the Specific Law (4) (hereinafter referred to as the competent authority).
(b) The manufacturer or importer shall submit an application for approval to the competent authority. The application shall be accompanied by the technical documentation describing the method.
(c) For supervisory purposes, the manufacturer or importer shall be authorised by the competent authority, the technical documentation describing the method and, where appropriate, the control reports readily available at the address indicated on the label in accordance with Article 6 (1) (a).
(d) The technical file shall be drawn up in the official language of the European Communities or a certified copy thereof shall be made available.
2. Examples of control tests which may be carried out
2.1 Testing of unfilled containers
2.1.1. Five containers selected from a homogeneous group of 2500 unfilled containers shall be subjected to a pressure test for 25 seconds. The same group is a group of containers made of the same materials using the same continuous-dose production process or a group of containers representing one-hour production.
2.1.2. If one of these containers fails the test, a further 10 containers shall be selected from the same homogeneous group and subjected to the same test.
2.1.3. If any of these 10 containers fail the test, the whole group is unsuitable for use.
2.2 Tests of filled aerosol dispensers
2.2.1 Air and water-tight tests shall be carried out by immersing the selected number of aerosol dispensers in the water bath. The temperature of the bath and immersion time should be selected so that the aerosol dispenser is filled at a uniform temperature of 50 ° C during the time required to guarantee that no rupture or rupture has occurred.
2.2.2 Each batch of aerosol dispensers that does not pass these tests shall be considered unfit for use.
3. Tests for aerosol flammable
3.1 Flash distance test for spray aerosols
3.1.1 Introduction
3.1.1.1. This test procedure determines the ignition distance of the aerosol spray to assess the associated flame hazard. The aerosol is sprayed towards the ignition source at intervals of 15 cm to see if the ignition and permanent ignition of the powder occur. The ignition and permanent combustion is defined as maintaining a stable flame for at least 5 seconds. The ignition source is defined as a gas burner with a blue non-light flame at a height of 4- 5 cm.
3.1.1.2. This test is applicable to aerosol products with a spray distance of 15 cm or more. Aerosol products with a spray distance of less than 15 cm, such as aerosol products applied in the form of foam, unstable foams, gel or paste or equipped with a dosing valve, are excluded from this test. Aerosol products applied in the form of foam, unstable foam, gel or paste shall be tested according to the aerosol foam flammable test.
3.1.2. Instruments and material
3.1.2.1. The following instruments are required:
| vodní lázeň udržovaná na 20 °C | s přesností ± 1 °C |
| kalibrované laboratorní váhy (váhy) | s přesností ± 0,1 g |
| měřič času (stopky) | s přesností ± 0,2 s |
| měřidlo se stupnicí, držák a svorka | stupně v cm |
| plynový hořák s držákem a svorkou | |
| teploměr | s přesností ± 1 °C |
| vlhkoměr | s přesností ± 5 % |
| tlakoměr | s přesností ± 10 kPa |
Procedure
3.1.3.1. General requirements
3.1.3.1.1. Before the test, each aerosol dispenser is conditioned and then rinsed by emptying for about 1 second The purpose of this measure is to remove non-homogeneous material from the climb pipe.
3.1.3.1.2. The instructions for use shall be strictly followed, including whether the sprayer is intended for use in a vertical or inverted position. Shake immediately before testing if shaking is required.
3.1.3.1.3. The test shall be carried out in a non-draught environment with ventilation capability, with a temperature adjustable to 20 ° C ± 5 ° C and a relative humidity of between 30 and 80%.
3.1.3.1.4. Each aerosol dispenser shall be tested
a) if full, a complete procedure is carried out, with a gas burner in the range of 15 cm to 90 cm from the nozzle of the aerosol container,
(b) if it is filled from 10% to 12% (% of nominal weight), it shall be subjected only to a single test, either 15 cm from the nozzle of the container, if the powder has not ignited at all at the filled dispenser, or at the distance of the ignition of the solid dispenser plus 15 cm.
3.1.3.1.5. During the test, the container shall be placed as specified on the label. This will also guide the ignition source position.
3.1.3.1.6. The following procedure requires testing of the spray at intervals of 15 cm at the distance between the burner flame and the spray nozzle, ranging from 15 cm to 90 cm. It is appropriate to start at a distance of 60 cm between the burner flame and the spray nozzle. The distance between the burner flame and the spray nozzle should be increased by 15 cm if the powder ignites at 60 cm. The distance shall be reduced by 15 cm if the powder does not ignite within a 60-centimeter distance between the burner flame and the spray nozzle. The aim of the procedure is to determine the maximum distance between the spray nozzle and the burner flame that leads to the permanent flame of the spray, or to determine that the ignition could not have occurred at a distance of 15 cm between the burner flame and the spray nozzle.
3.1.3.2. Test procedure
(a) Before each test, at least three full aerosol dispensers from each product type shall be conditioned by immersing at least 95% of the dispenser in water at a temperature of 20 ° C ± 1 ° C for at least 30 minutes (if the aerosol is fully immersed, 30 minutes conditioning is sufficient).
b) Follow the general requirements. Record temperature and relative humidity.
c) Consider the aerosol dispenser and record its weight.
d) Determine the internal pressure and default charge at 20 ° C ± 1 ° C (to avoid defective or only partially filled aerosol dispensers).
e) Attach the gas burner to a flat horizontal surface or attach it to the holder by means of a clamp.
f) Light the gas burner; The flame should be non-luminous and approximately 4 to 5 cm high.
g) Place the spray nozzle inlet within the required distance from the flame. The sprayer shall be tested in the position in which it is intended to be used in accordance with its design, i.e. vertical or inverted.
h) Ensure that the nozzle opening is directed into one plane with the burner flame so that the nozzle opening is properly directed towards and along the flame (see Figure 3.1.1). The powder should be directed over the top half of the flame.
Figure 3.1.1
i) Follow the general requirements for shaking the sprayer.
j) Activate the aerosol dispenser valve for 5 seconds to empty its contents if no ignition occurs. If ignition occurs, continue emptying for the duration of the flame up to 5 s from the beginning of the ignition.
k) The results of the ignition at the appropriate distance between the gas burner and the aerosol dispenser shall be recorded in the table below.
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Regulation Information
| Citation | Government Regulation No. 315 / 2009 Coll., amending Government Regulation No. 194 / 2001 Coll., laying down technical requirements for aerosol dispensers, as amended by Government Regulation No. 305 / 2006 Coll. |
|---|---|
| Regulation Type | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 11.09.2009 |
|---|---|
| Effective from | 29.04.2010 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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