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Royal Decree 1381 / 2009, 28 August, Which Lays Down The Requirements For The Manufacture And Marketing Of Aerosol Generators.

Original Language Title: Real Decreto 1381/2009, de 28 de agosto, por el que se establecen los requisitos para la fabricación y comercialización de los generadores de aerosoles.

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TEXT

By Royal Decree 472/1988 of 30 March 1988, the detailed rules for the application of Council Directive 75 /324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to the Aerosol generators, with all these regulations being integrated into the complementary technical instruction MIE-AP3, of the Regulation of Apparatus to Pressure, approved by Royal Decree 1244/1979, of 4 April.

Subsequently, by Royal Decree 2549/1994 of 29 December 1994, the supplementary technical instruction MIE AP3 was amended in the light of the adoption of Commission Directive 94 /1/EC of 6 January 1994 on the technical adaptation of Directive 75 /324/EEC. In this royal decree, by regulatory economy, the provisions concerning aerosol dispensers were included in a single regulatory text.

Recently, Commission Directive 2008 /47/EC of 8 April 2008 has again amended, in order to adapt it to technical progress, Directive 75 /324/EEC on aerosol dispensers.

The most important changes introduced by this Directive are the acceptance of alternative methods of inspection to the hot water bath for the conditioned aerosol dispensers and the establishment new criteria for the flammability of aerosols taking into account not only the physical and chemical properties of their contents but also the conditions of use and, where appropriate, the examination of the risk resulting from the inhalation of the normal or reasonably foreseeable conditions of use, issues which had not been as defined in the previous amendment by Directive 94 /1/EC.

Directive 97 /23/EC of the European Parliament and of the Council of 29 May 1997 on the approximation of the laws of the Member States relating to pressure equipment was incorporated into the Spanish legal order by Royal Decree 769/1999, of 7 May, which came to amend Royal Decree 1244/1979 of 4 April, which approved the previous Regulation of pressure equipment. Although the Royal Decree, 769/1999 of 7 May, refers to the design, manufacture and conformity assessment of pressure equipment with a maximum permissible pressure of more than 0,5 bar, with the exception of its scope to the generators of aerosols. This Directive has led to the need to revise national legislation on pressure equipment to modify, inter alia, its scope, which is defined only for installation, periodic reviews, modifications and repairs. Therefore, it could not be included in the pressure equipment regulation, which was recently approved by Royal Decree 2060/2008 of 12 December, a complementary technical instruction (ITC) relating to manufacturing requirements. Hence the need to establish an independent regulation for aerosol dispensers outside the new pressure equipment regulation.

By regulatory economy, it is considered appropriate to include in a single regulatory text the provisions relating to aerosol dispensers, including the provisions of Directive 75 /324/EEC, as amended for its adaptation to technical progress by Directives 94 /1/EC and 2008 /47/EC. At the same time, in accordance with Article 30 et seq. of the Treaty establishing the European Community (TEC), they shall be admitted on the Spanish market, in addition to aerosols manufactured in accordance with this provision, those other which may be manufactured and controlled in accordance with the technical regulations of the Member States, provided that they guarantee and are recognised at least the same level of protection and security as the one reached with the legislation that is now set.

In the project phase, this royal decree has been submitted to the hearing procedure prescribed in article 24.1.c) of Law 50/1997 of 27 November, of the Government and the autonomous communities have been consulted. It has also issued a favourable report on the royal decree of the Industrial Security Coordination Council.

This provision is dictated by the provisions of Article 149.1.13. of the Spanish Constitution, which attributes to the State the competence to determine the bases and coordination of the general planning of the activity. Article 149.1.10. of the Constitution, which attributes exclusive competence to the State in matters of foreign trade, without prejudice to the powers of the autonomous communities in matters of industry.

This regulation is of a basic regulation and contains forecasts of an exclusive and markedly technical nature, and the law is therefore not the ideal instrument for its establishment and its approval is justified. by royal decree.

Under its virtue, on a proposal from the Ministry of Industry Tourism and Trade, according to the Council of State and after deliberation of the Council of Ministers at its meeting of 28 August 2009,

DISPONGO:

Article 1. Object.

Constitutes the object of this royal decree the establishment of standards and criteria for the proper manufacture and marketing of the aerosol dispensers included in its scope.

Article 2. Definition of aerosol generator.

For the purposes of this royal decree, an aerosol generator means the assembly consisting of a non-reusable container of metal, glass or plastic containing a compressed gas "liquefied or dissolved under pressure" with or without liquid, paste or powder, and is provided with a discharge device allowing the output of the content in the form of solid or liquid particles suspended in a gas, in the form of foam, paste or powder, or in liquid state.

Article 3. Scope of application.

This royal decree will apply to aerosol dispensers, as defined in Article 2 of this royal decree except for those whose container has a total capacity of less than 50 ml, and those whose container has a total capacity greater than that referred to in paragraphs C) 1, D) 1.1., D) 2.1., E) 1 and E) 2 of the Annex to this Royal Decree; this is: 1,000 ml for metal containers, 220 ml for plasticized glass containers or permanently protected or in the event of breakage they cannot be chipped, or 150 ml for glass containers permanently protected or in the event of breakage.

Article 4. Marked.

The person responsible for placing on the market the aerosol dispensers shall affix the sign "3" (inverted epsilon) to the latter by means of which it shall be certified that the aerosols conform to the requirements of the actual present Decree and its Annex.

Article 5. Marketing.

It shall not be possible to refuse, prohibit or restrict the placing on the market of aerosol dispensers which comply with the requirements of this Royal Decree and its Annex.

When it is established, for sound reasons, that one or more aerosol dispensers, even if they comply with the requirements of this Royal Decree, pose a danger to safety or health, it may be provisionally prohibited or subject to special conditions the placing on the market of such aerosol dispensers, and the General Administration of the State shall immediately inform the other Member States and the Commission thereof, stating the reasons on which the for the purposes of the provisions of Article 10 (2) and (3) of the Directive, 75 /324/EEC.

Article 6. Tagged.

1. Without prejudice to other provisions transposing Community directives, in particular those relating to dangerous substances and mixtures, aerosol dispensers, or the label attached to them when they are unable to carry recorded indications because of their small dimensions (total capacity equal to or less than 150 ml), must bear the following indications in a visible, legible and indelible manner:

(a) The name and address or trademark of the person responsible for the marketing of the aerosol generator.

b) The symbol according to the present royal decree, that is, the sign "3" (inverted epsilon).

c) Encrypted indications that allow the production batch to be identified.

(d) The entries listed in paragraphs (B) 2 and (B) 3 of the Annex.

e) Net content by weight and by volume.

2. Where an aerosol generator contains flammable components as defined in paragraph (A) 8 of the Annex, but is not considered to be 'flammable' or 'extremely flammable' in accordance with the criteria set out in paragraph (A) 9 of the Annex, the quantity of flammable material contained in the aerosol dispenser must be clearly stated on the label including in a legible and indelible form the following text: "contains an X% mass of flammable components".

3. The labelling of aerosol dispensers placed on the market in Spain shall be drawn up, at least, in Spanish, without prejudice to the coexistence of indications in other languages.

Article 7. Other brands.

No aerosol dispensers with marks and inscriptions which can be confused with the sign "3" (inverted epsilon) may be placed on the market.

Single additional disposition. Generators from other Member States.

In accordance with Article 30 et seq. of the Treaty establishing the European Community (TEC) and without prejudice to the provisions of this royal decree, they will be admitted to the Spanish market, in addition to manufactured aerosols. in accordance with the provisions of this provision, those other which may be manufactured and controlled in accordance with the technical regulations of the Member States, provided that at least the same level of security is guaranteed and recognized as protection and security that is achieved with the legislation that is now being established.

Single repeal provision. Repeal of regulations.

Royal Decree 2549/1994 of 29 December 1994 amending the supplementary technical instruction MIE-AP3 of the Regulation of pressure equipment for aerosol dispensers is hereby repealed.

Final disposition first. Competence title.

This royal decree is issued in accordance with the provisions of Article 149.1.13 of the Constitution, which attributes to the State the competence on the basis and coordination of the general planning of economic activity, and of the Article 149.1.10. of the Constitution, which attributes exclusive competence to the State in matters of foreign trade.

Final disposition second. Incorporation of European Union law.

This royal decree incorporates into Spanish law Commission Directive 2008 /47/EC of 8 April 2008 amending, in order to adapt it to technical progress, Council Directive 75 /324/EEC on the approximation of the laws of the Member States relating to aerosol dispensers.

Final disposition third. Entry into force.

This royal decree will enter into force on April 29, 2010.

Given in Palma de Mallorca, 28 August 2009.

JOHN CARLOS R.

The Minister of Industry, Tourism and Trade,

MIGUEL SEBASTIAN GASCON

ANNEX

Technical Prescriptions

A) Definitions

1. Pressures. -By "pressures" means internal pressures expressed in bars (relative pressures).

2. Test pressure. 'Test pressure' means the pressure at which the empty container of the aerosol generator may be subjected for 25 seconds without any escaping and without the metal or plastic containers having to be produced visible and permanent deformations, with the exception of those permitted under paragraph F) 1.1.2.

3. Break pressure.-The minimum pressure resulting from an opening or a break of the aerosol generator vessel is defined by the 'breaking pressure'.

4. Total capacity of the vessel. 'Total capacity' means the volume, expressed in millilitres, of an open container, measured up to the level of its opening.

5. Net capacity: 'Net capacity' means the volume, expressed in millilitres, of the aerosol generator container.

6. Volume of the liquid phase. -Volume of the liquid phase is understood to be the volume occupied by the non-gaseous phases in the aerosol generator container.

7. Test conditions. 'Test conditions' means test and break pressures applied hydraulically at 20 ° C (± 5 ° C).

8. Flammable components. -The contents of the aerosols shall be considered flammable if they contain any component which is classified as "flammable":

(a) 'flammable liquid' means a liquid with a flash point (ignition point) not exceeding 93 ° C;

(b) "flammable solid" means a substance or a solid mixture easily combustible or liable to cause or contribute to a friction fire; substances or mixtures of pulverulent substances are readily combustible; granular or pasty that are dangerous if they can be easily inflamed by short contact with an ignition source, such as a lit fence, and if the flame spreads rapidly;

(c) means "flammable gas" means a gas or a mixture of gases with a range of flammability with air at 20 ° C and a reference pressure of 1,013 bar.

This definition does not include pyrophoric, self-heating substances and mixtures (those experiencing spontaneous warming) or hydroreactive substances (those that react in contact with water), which should never be part of the contents of the aerosols.

9. Flammable aerosols.-The effects of this royal decree shall be deemed to be 'non-flammable', 'flammable', or 'extremely flammable' in the light of its chemical heat of combustion and the mass content of flammable components, as follows:

(a) the aerosol shall be classified as 'extremely flammable' if it contains 85% or more flammable components and the chemical heat of combustion is greater than or equal to 30 kJ/g;

(b) the aerosol shall be classified as 'non-flammable' if it contains 1% or less flammable components and its chemical heat of combustion is less than 20 kJ/g;

(c) all other aerosols shall be subjected to the flammability rating procedures set out below or classified as 'extremely flammable'; the ignition distance test shall be carried out at the same time. ignition test in closed space and the flammability test of foam products shall comply with paragraph F) 3. "Aerosol flammability tests"

9.1 flammable spraying Aerosols: In the case of spray sprays, the classification shall be carried out on the basis of the chemical heat of combustion and on the basis of the results of the ignition distance test, as follows:

a) if the chemical heat of combustion is less than 20 kJ/g:

i) the aerosol shall be classified as "flammable" if the ignition occurs at a distance of 15 cm. or more but less than 75 cm.

(ii) the aerosol shall be classified as 'extremely flammable' if the ignition occurs at a distance equal to or greater than 75 cm.

(iii) if the ignition distance test does not occur, the ignition test shall be carried out in enclosed space 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 deflagration density is less than or equal to 300 g/m3; otherwise, the aerosol will be classified as "non-flammable".

(b) if the chemical heat of combustion is equal to or greater than 20 kJ/g, the aerosol shall be classified as 'extremely flammable' if the ignition occurs at a distance of 75 cm or more; otherwise, the aerosol shall be classifies as "flammable".

9.2 flammable foam Aerosols: In the case of foam aerosols, the classification shall be carried out on the basis of the results of the flammability test of foam products.

a) The aerosol will be classified as "extremely flammable":

i) if the flame height is equal to or greater than 20 cm and the flame is maintained for 2 seconds or more, or

ii) if the flame height is equal to or greater than 4 cm and the flame holds for 7 seconds or more;

(b) The aerosol which does not meet the criteria set out in point (a) shall be classified as 'flammable' if the flame height is equal to or greater than 4 cm and the flame is maintained for 2 seconds or more.

10. Chemical heat of combustion. -Chemical heat of combustion,c will be determined:

a) by means of recognized technological rules, described for example in standards such as ASTM D 240, ISO 13943 86.1 to 86.3 and NFPA 30B, or found in the established scientific literature, or

b) by applying the following calculation method:

The chemical heat of combustion (c), in kilojulios per gram (kJ/g), can be calculated as the product of the theoretical heat of combustion, (comb) and the efficiency of combustion, usually less than 1.0 (typical combustion efficiency is 0.95 or 95%).

For a compound aerosol preparation, the chemical heat of combustion is the sum of the weighted combustion heat of each of its components, according to the following formula:

Imagen: img/disp/2009/230/15056_001.png

where:

c = chemical combustion heatthe product.

wi% = mass fraction of component i in the product.

c (i) = specific combustion(kJ/g) of component i on the product.

The person responsible for the marketing of the aerosol generator should describe the method used to determine the chemical heat of combustion in a document drawn up in an official language of the European Community to which it must be easily accessible in the direction indicated on the label in accordance with the provisions of Article 6 (a) (a), in case the chemical heat of combustion is used as a parameter to assess the flammability of aerosols according to the provisions of this royal decree.

11. Aerosol conditioner. -aerosol generator that is adjusted under conditions of use and storage to the current regulations.

12. Conditioning. -Preparing and disposing of the fluids and components of an aerosol generator in an appropriate manner.

B) General provisions

Without prejudice to specific provisions of the Annex relating to the requirements for the danger of flammability and pressure, the person responsible for the marketing of aerosol dispensers shall be required to analyse the hazards to identify those that are applicable to their products. Where appropriate, this analysis shall include an examination of the risks resulting from the inhalation of the spray emitted by the aerosol generator under normal or reasonably foreseeable conditions of use, taking into account the size distribution of the drops in combination with the physical and chemical properties of the contents. It shall then design, manufacture and test it and, where appropriate, draw up special declarations concerning its use, taking into account the analysis it has made.

1. Manufacturing and equipment.

(a) The aerosol generator must comply, under normal conditions of use and storage, with the provisions of this Annex.

(b) The valve, under normal storage and transport conditions, shall permit the practically hermetic closure of the aerosol generator and be protected against any inadvertent opening and any possibility of deterioration, for example by a protective capsule.

(c) The mechanical strength of the aerosol generator must not be affected by the action of the substances contained in the container, even for an extended period of storage.

2. Labelling.-Without prejudice to the provisions of the Directives on the classification, packaging and labelling of dangerous substances and preparations and to Regulation (EC) No 1272/2008, in particular as regards the danger to health and safety, the environment, any aerosol generator must bear the following particulars in a visible, legible and indelible manner:

a) Whatever its content: " Pressure received. Protect yourself from the sun's rays and avoid exposing it to temperatures above 50 ° C. Do not drill or burn, even after use. "

(b) When the aerosol is classified as "flammable" or "extremely flammable" according to the criteria in paragraph A) 9:

The symbol of the flame, in accordance with the model in Annex II to Royal Decree 363/1995 of 10 March on the classification, packaging and labelling of dangerous substances.

The indication of "flammable" or "extremely flammable", depending on the classification of the aerosol as "flammable" or "extremely flammable".

3. Specific indications for use. -Without prejudice to the provisions of the Directives on the classification, packaging and labelling of dangerous substances and preparations and Regulation (EC) No 1272/2008, in particular as regards the hazard to health or the environment, any aerosol generator must bear the following particulars in a visible, legible and indelible manner:

(a) Whatever their content, all additional handling precautions that warn consumers of the specific hazards of the product; if the aerosol generator carries out separate employment instructions, in they must also include such handling precautions;

(b) When the aerosol is classified as "flammable" or "extremely flammable" according to the criteria in paragraph A) 9, the following warnings:

Safety phrases S2 and S16 set out in Annex IV to Royal Decree 363/1995 of 10 March on classification, packaging and labelling of dangerous substances.

Do not vaporize to an incandescent flame or body.

4. Volume of the liquid phase. The volume of the liquid phase at 50 ° C shall not exceed 90% of the net capacity.

C) Special provisions for aerosol dispensers whose container is of metal

1. Capacity. The total capacity of such vessels may not exceed 1,000 ml.

1.1 Canister Test Pressure:

(a) With regard to containers which must be conditioned at a pressure below 6,7 bar at 50 ° C, the test pressure must be at least 10 bar.

(b) For containers to be conditioned at a pressure equal to or greater than 6,7 bar at 50 ° C, the test pressure must be 50% higher than the internal pressure at 50 ° C.

1.2 Conditioning:

At 50 ° C, the pressure of the aerosol generator must not exceed 12 bar.

However, if the spray does not contain a gas or a mixture of gases with a range of flammability with air at 20 ° C and a reference pressure of 1,013 bars, the maximum permissible pressure at 50 ° C shall be 13,2 bar.

(D) Special provisions for aerosol dispensers with a glass container

1. Containers that are plasticized or permanently protected. -Such containers may be used for conditioning with compressed, liquid or dissolved gas.

1.1 Capacity: The total capacity of such containers may not exceed 220 ml.

1.2 Coating: The coating must be made up of a protective wrap of plastic material or of any other suitable material, in order to avoid the risk of projecting fragments in case of accidental rupture of the container, and must be manufactured in such a way that no glass fragments are projected when the aerosol generator, subjected to the temperature of 20 ° C, falls from a height of 1,8 metres above a concrete floor.

1.3 Canister Test Pressure:

(a) The containers used for conditioning with compressed or dissolved gas shall withstand a test pressure at least equal to 12 bars.

(b) The containers used for conditioning with liquefied gas must withstand a test pressure of at least 10 bar.

1.4 Conditioning:

(a) Aerosol generators fitted with compressed gases, at 50 ° C, must not exceed a pressure of 9 bar.

(b) Aerosol dispensers with dissolved gases at 50 ° C shall not exceed a pressure of 8 bar.

(c) Aerosol generators fitted with liquefied gases or mixtures of liquefied gases must not exceed, at 20 ° C, the pressures indicated in the following table:

Between 80 ml. and 160 ml

Capacity

Percent of Liquefied Gas in Total

20%

50%

80%

50 to 80 ml

3.5 bar

2.8 bars

2.5

3.2 bars

2.5 bars

2.2 bars

160 ml and 220 ml

2.8 bars

2.1 bars

1.8 bars

This table shows the allowable pressure limits at 20 ° C depending on the percentage of gas.

For gas percentages not listed in this table, the limit pressures shall be calculated by extrapolation.

2. Non-protected glass containers: aerosol dispensers using non-protected glass containers shall be exclusively conditioned by liquefied or dissolved gas.

2.1 Capacity: The total capacity of such vessels may not exceed 150 ml.

2.2 Container test pressure: This pressure must be at least 12 bar.

2.3 Conditioning:

(a) Aerosol dispensers fitted with dissolved gases must not exceed, at 50 ° C, a pressure of 8 bar.

(b) Aerosol generators fitted with liquefied gases shall not exceed, at 20 ° C, the pressures indicated in the following table:

Capacity

Percentage of Liquefied Gas in Total

20 per 100

50 per 100

80 per 100

50 and 70 m

1.5 bars

1.5 bars

1.25 bars

Between 70 and 150 m

1.5 bars

1.5 bars

1 bars

This table shows the allowable pressure limits at 20 ° C depending on the percentage of liquefied gas.

For gas percentages not indicated in that table, the limits pressures shall be calculated by extrapolation.

E) Special provisions relating to aerosol dispensers with a plastic container.

1. Aerosol dispensers with a plastic container and which, in the event of breakage, may be chipped, shall be treated as aerosol dispensers, the container of which is non-protected glass.

2. Aerosol dispensers with a plastic container and which, in the event of breakage, cannot be chipped, shall be treated as aerosol dispensers, the container of which is made of glass with protective wrapping.

F) Tests

1. Requirements relating to the tests to be carried out by the person responsible for placing the product on the market:

1.1 Hydraulic testing with empty containers:

1.1.1 The metal, glass or plastic containers of the aerosol dispensers must be able to withstand a hydraulic pressure test according to points C) 1.1., D) 1.3. and D)

.

1.1.2 Metal containers with asymmetric deformations or other important deformations or similar defects shall be discarded. When the container satisfies the break test, a slight symmetrical deformation of the bottom or those affecting the profile of the top wall shall be permitted.

1.2 Test of breaking of empty metal containers: The person responsible for placing the product on the market must ensure that the pressure of the vessel's breakage exceeds, at least 20%, the test pressure provided.

1.3 Test of fall of protected glass containers: The manufacturer shall ensure that the containers meet the test conditions referred to in paragraph (D) 1.2.

1.4 Final inspection of conditioned aerosol generators.

1.4.1 The aerosol dispensers will be subjected to one of the following final test methods:

a) Hot water bath test: Each conditioner generator will be immersed in a hot water bath.

i) The temperature of the water bath and the duration of the test shall be such that the internal pressure reaches the value that its contents would be used at a uniform temperature of 50 ° C.

(ii) Any aerosol generator with permanent visible deformation or leakage shall be rejected.

(b) Hot final test methods: Other methods for heating the content of aerosol dispensers may be used if they ensure that the pressure and temperature of each aerosol generator reaches the values required in the hot water bath test and if the deformations and leaks are detected with the same accuracy as in that test.

(c) Cold final test methods: An alternative cold final test method may be used if it is in accordance with the provisions concerning the alternative method to the hot water bath system for aerosol dispensers. specified in Annex A, paragraph 6.2.4.3.2.2 of Directive 94 /55/EC.

1.4.2 In the case of aerosol dispensers whose contents undergo a physical or chemical transformation that modifies their pressure characteristics after conditioning and prior to their first use, methods of cold final test in accordance with paragraph F) 1.4.1. (c).

1.4.3 For testing methods according to paragraph F) 1.4.1, points (b) and (c);

(a) the test method must be approved by a competent authority;

(b) the person responsible for the placing on the market of aerosol dispensers shall submit an application for authorisation. The application must be accompanied by the technical file describing the method;

(c) for surveillance purposes, the person responsible for the placing on the market of aerosol dispensers shall be able to keep easily accessible at the address indicated on the label in accordance with Article 6.1.a. of the competent authority, the technical file describing the method and, where appropriate, the control reports;

(d) the technical file must be in an official language of the European Community, or a certified copy of it must be available;

(e) "competent authority" means the designated authority in each Member State in accordance with Royal Decree 551/2006 of 5 May.

2. Examples of control tests that can be carried out by Member States:

2.1 Testing with empty containers:

For twenty-five seconds, a test pressure shall be applied to five randomly selected vessels of a homogeneous batch of 2,500 empty containers, i.e. manufactured with identical materials and by the same procedure, in continuous string, or a batch that constitutes the production of an hour.

If only one of those containers does not satisfy the test, then at random, in the same batch, ten other containers shall be chosen, which shall be subjected to the same test. When any such vessel does not comply with the test, the whole lot shall be considered unusable.

2.2 Test of conditioned aerosol dispensers: Control tests of the airtight of the conditioned aerosol dispensers will be carried out by immersion in a water bath, of a significant number of such generators. The temperature of the water and the duration of the dip in the bath must allow the contents to reach the uniform temperature of 50 ° C for as long as necessary to ensure that there is no escaping or breakage. Aerosol dispensers that do not satisfy this test shall be considered unusable.

3. Test for flammability of aerosols:

3.1 Test of ignition distance for spray sprays:

3.1.1 Introduction:

3.1.1.1 This normalized test describes the method for determining the ignition distance of a spray spray to assess the risk of inflammation. The spray is sprayed in the direction of an ignition source at 15 cm intervals to observe if ignition occurs and sustained combustion of the spray. Ignition and sustained combustion occurs when a stable flame is maintained for at least 5 seconds. The ignition source is defined as a gas lock with a non-luminous blue flame of 4-5 cm. high.

3.1.1.2 This test is applicable to aerosols with a spray distance equal to or greater than 15 cm. Aerosols with a spray distance of less than 15 cm. are excluded from this test, such as foams, creams, gels and pastes, or fitted with a metering valve. Aerosols dispensing foams, creams, gels or pastes should be subjected to the flammability test of aerosol foam products.

3.1.2 Instrumental and Material.

3.1.2.1 The following instrumental is required:

Water bath kept at 20 ° C: Precision of ± 1 ° C.

Calibrated lab scales: Precision of ± 0.1 g.

Stopwatch: Precision of ± 0.2 s.

Graduate rule, support, and clamp. Gas Mechero with support and clamp: Graduation in cm.

Thermometer: Precision of ± 1 ° C.

Higrometer: Precision of ± 5%.

Gauge: Precision of ± 0.1 bar.

3.1.3 Procedure:

3.1.3.1 General requirements.

3.1.3.1.1 Before testing, the aerosol generator must be conditioned and primed by discharge for approximately 1 s. The purpose of this action is to remove non-homogeneous material from the immersion tube.

3.1.3.1.2 The employment instructions will be strictly followed, in particular the instruction of whether the aerosol generator should be used in a vertical or inverted position. When it is necessary to shake it, it must be done immediately before the test.

3.1.3.1.3 The test shall be carried out in an environment without air currents and which can be ventilated, with the temperature controlled at 20 ° C ± 5 ° C and a relative humidity of 30-80%

3.1.3.1.4 Every aerosol generator must be tested:

a) When filled, following the complete procedure, with the gas lock in the range of 15-90 cm from the diffuser of the aerosol container;

b) When it is 10-12% of its net content (en masse), a single test must be done, 15 cm away from the diffuser if the ignition or the ignition distance of the filled spray plus 15 was not produced with the full package. cm.

3.1.3.1.5 The position of the container during the test must be in accordance with the instructions on the label. The ignition source will be positioned based on the above.

3.1.3.1.6 The following procedure requires that the aerosol generator be tested at intervals of 15 cm between the call of the mechero and the spray diffuser, in a range of 15-90 cm. It is effective to start with a distance of 60 cm. between the call of the tuft and the spray diffuser. If the ignition of the aerosol generator is produced at 60 cm., the distance between the call of the mechero and the spray diffuser will be increased by 15 cm. If the ignition of the aerosol generator is not produced at 60 cm, the distance between the call of the mechero and the spray diffuser will be reduced by 15 cm. The purpose of this procedure is to determine the maximum distance between the aerosol diffuser and the call of the tuft to which sustained combustion of the aerosol generator occurs, or to determine that with the spray diffuser at 15 cm of the flame The ignition is not achieved.

3.1.3.2 Test Procedure.

(a) A minimum of three aerosol-filled aerosol generators shall be conditioned at 20 ° C ± 1 ° C with at least 95% of the generator immersed in the water for at least 30 minutes prior to each test (if the aerosol is submerged). completely, 30 minutes of conditioning will be sufficient).

b) Adjusting to general requirements. Log the temperature and relative humidity of the environment.

c) Weigh the aerosol generator and write down its mass.

d) Determine the internal pressure and initial download speed at 20 ° C ± 1 ° C (to remove the defective or partially loaded aerosol dispensers).

e) Support the gas lock on a horizontal flat surface or attach it to a support by means of a clamp.

f) Turn on the gas lock; the flame must be non-luminous and be approximately 4-5 cm high.

g) Place the outlet orifice of the diffuser at the required distance of the flame. The spray shall be tested at the indicated position of use, for example in a vertical or inverted position.

h) Nivate the orifice of the diffuser and the call of the mechero, making sure that the hole is correctly directed towards the flame and aligned with it (see figure 3.1.1). The spray shall be directed towards the upper half of the flame.

Imagen: img/disp/2009/230/15056_002.png

i) Shake the aerosol generator according to the general requirements.

j) Actioning the aerosol generator valve to discharge its contents for 5 s, unless ignition occurs. If ignition occurs, continue to discharge and observe if the flame is maintained for 5 s, from the time the ignition starts.

k) Anote in the forecast table the ignition results corresponding to the distance between the gas lock and the aerosol generator.

l) If the ignition in step (j) does not occur, the spray shall be tested in alternative positions, i.e. in the inverted position in the case of products to be used in a vertical position, to check whether this is the case there is ignition.

m) Repeat steps g) to l) twice more (a total of three) with the same container and at the same distance between the gas lock and the spray diffuser.

n) Repeat the test procedure with two other aerosol containers of the same product at the same distance between the gas lock and the spray diffuser.

o) Repeat steps g) to n) of the test procedure at a distance between 15 and 90 cm between the sprayer of the aerosol container and the call of the lock, depending on the result of each test (see also paragraphs F) 3.1.3.1.4 and F) 3.1.3.1.5).

p) If no ignition occurs at 15 cm. the procedure is terminated for the containers initially filled. It is also terminated when ignition and sustained combustion are produced at a distance of 90 cm. If the ignition was not achieved 15 cm apart, note that there was no ignition. In all other circumstances, the maximum distance between the mechero flame and the spray diffuser to which the ignition was observed and sustained combustion is noted as "ignition distance".

q) Another test must be carried out on three containers with a filling level of 10-12% of their net content. These packages shall be tested at a distance between the spray diffuser and the call of the mechero equivalent to the "ignition distance of the filled containers plus 15 cm".

r) Download the aerosol container up to 10-12% of its net content (en masse) with pulverizations of up to 30 s. A minimum period of 300 s must be observed between one spray and another. During this intermediate period, aerosol dispensers will be conditioned by placing them in the water bath.

s) Repeat steps g) to n) with aerosol containers filled to 10-12% of their net content, omitting steps l) and m). This test will be done with the spray in a single position, for example in a vertical or inverted position, corresponding to the one that produced the ignition (if produced) with filled containers.

t) Score all results in Table 3.1.1.

3.1.3.2.1 All experiments must be carried out in a smoke extractor campaign inside a room that can be well ventilated. The extractor campaign and the room must be ventilated for at least 3 minutes after each test. All necessary safety precautions shall be taken to prevent the inhalation of combustion products.

3.1.3.2.2 Packaging filled to 10-12% of its net content will be tested once. Only one result per package shall be indicated in the result tables.

3.1.3.2.3 When testing with the aerosol generator in the position of use for which it is designed for a negative result, the test will be repeated in the position with which it is most likely to obtain a positive result.

3.1.4 Method of evaluating results:

3.1.4.1 All results should be noted. Table 3.1.1 presents the model of the "table of results" to be used.

Date

Temperature ... ° C

Relative Humidity ......... %

Name

Volume

 

Pack 1

Pack 2

Pack 3

Initial Fill Level

%

%

%

% of the aerosol generator distance

Test

1..........2.......3

1........2........3

1.........2.......3

15 cm

Ignition?

S or N

30 cm

Ignition?

S or N

45 cm

Ignition?

S or N

60 cm

Ignition?

S or N

75 cm

Ignition?

S or N

90 cm

Ignition?

S or N

; indicate, in particular, the container position

Table 3.1.1

3.2 Test for ignition in closed space.

3.2.1 Introduction:

This normalized test specifies a method for determining the flammability of a product dispensed by an aerosol generator, because of the tendency of it to become inflamed in a closed or confined space.

The contents of the aerosol generator are pulverized in a cylindrical test container that contains a lit candle inside. If an appreciable ignition occurs, the elapsed time and the unloaded amount are logged.

3.2.2 Instrumental and Material.

3.2.2.1 The following instrumental is required:

Stopwatch: Precision of ± 0.2 s.

Water bath kept at 20 ° C: Precision of ± 1 ° C.

Calibrated laboratory scale: Precision of ± 0,1 g.

Thermometer: Precision of ± 1 ° C.

Higrometer: Precision of ± 5%.

Gauge: Precision of ± 0.1 bar.

cylindrical test canister: As detailed below.

3.2.2.2 Preparing the test instrument.

3.2.2.2.1 The cylindrical drum of 200 dm3 of volume, 600 mm in diameter and 720 mm long, approximately, opened by one end, will be modified as follows:

(a) at the open end of the receptacle shall be fitted with a locking system consisting of a hinged lid, or;

(b) a plastic sheet of 0,01 to 0,02 mm thickness may also be used as a closure system. If the test is carried out with a plastic sheet, it shall be used as described below: stretch the sheet on the open end of the drum and fix it on its site by means of an elastic band; the resistance of the band shall be such that, placed around the drum supported on one side, only 25 mm is stretched when a mass of 0.45 kg is placed at its lowest point; make a cut of 25 mm in the sheet, starting at 50 mm from the edge of the drum; make sure that the sheet is taut;

c) at the other end of the drum, drill a hole 50 mm in diameter at 100 mm from the edge, so that the hole is positioned at the top when the receptacle is lying down and ready for testing (Figure 3.2.1);

Imagen: img/disp/2009/230/15056_003.png

d) placing on a 200 x 200 mm metal support a paraffin wax candle of 20 to 40 mm in diameter and 100 mm in height; the candle shall be replaced when its height is reduced to less than 80 mm; the flame of the candle is protected from the action of the aerosol by means of a deflector of 150 mm wide and 200 mm high. This includes a plane inclined at 45 ° that extends from 150 mm from the base of the baffle (Figure 3.2.2);

Imagen: img/disp/2009/230/15056_004.png

e) The candle is placed on the metal support and must be placed on a equidistant point between the two ends of the drum (Figure 3.2.3);

Imagen: img/disp/2009/230/15056_005.png

f) Tumbar the drum on the ground or on a support, in a place where the temperature is between 15 ° C and 25 ° C; the product under test will be sprayed into the drum of about 200 dm3, in which there will be an ignition source.

3.2.2.2.2 Normally, the product comes out of the aerosol container with an angle of 90 ° with respect to its vertical axis. The described configuration and method refer to this type of aerosol. In the case of unusual operating aerosols (e.g. vertical spray aerosol dispensers), it will be necessary to note the changes made to the equipment and procedures in accordance with good practice of laboratory, such as those of ISO/IEC EN 17025; General requirements for the competence of test and calibration laboratories.

3.2.3 Procedure.

3.2.3.1 General requirements:

3.2.3.1.1 Before testing, each aerosol generator shall be conditioned and baited by discharge for approximately 1 s. The purpose of this action is to remove non-homogeneous material from the immersion tube.

3.2.3.1.2 The employment instructions will be strictly followed, in particular the instruction of whether the aerosol generator should be used in a vertical or inverted position. When it is necessary to shake it, it must be done immediately before the test.

3.2.3.1.3 The test shall be carried out in an environment without air current and which can be ventilated, with the temperature controlled at 20 ° C ± 5 ° C and a relative humidity of 30-80%.

3.2.3.2 Test Procedure:

(a) A minimum of three aerosol generators filled by product at 20 ° C ± 1 ° C in a water bath with at least 95% of the generator immersed in the water for at least 30 minutes (if the aerosol is submerged) shall be conditioned. completely, 30 minutes of conditioning will be sufficient).

b) Measure or calculate the actual volume of the drum in dm3.

c) Adjusting to general requirements. Log the temperature and relative humidity of the environment.

d) Determine the internal pressure and initial download speed at 20 ° C ± 1 ° C (to remove the defective or partially loaded aerosol dispensers).

e) Pesar one of the aerosol dispensers and note down their mass.

f) Turn on the candle and apply the closure system (plastic cap or sheet).

g) Place the spray generator diffuser orifice 35 mm from the center of the drum inlet orifice, or closer if it is a wide spray product. Start the timer and, following the instructions for use of the product, direct the spray towards the centre of the opposite end (plastic cover or foil). The spray shall be tested at the indicated position of use, for example in a vertical or inverted position.

h) Pulverize until ignition occurs. Stop the timer and log the elapsed time. Re-weigh the aerosol generator and score its mass.

i) Ventar and clean the drum, eliminating any residue that may influence subsequent tests. If necessary, let it cool.

j) Repeat steps d) to i) of the test procedure with two other aerosol dispensers of the same product (three in total; each generator is tested once).

3.2.4 Results Assessment Method:

3.2.4.1 A test report will be written that contains the following information:

a) the test object product and its references;

b) the internal pressure and the discharge speed of the aerosol generator;

c) the temperature and relative humidity of the room;

d) in each test, the download time (s) required to get the ignition (if it does not occur, indicate it);

e) the pulverized product mass in each test (in g);

f) the actual volume of the drum (in dm3).

3.2.4.2 The equivalent time (teq) required to get the ignition in 1 cubic meter can be calculated as follows:

Imagen: img/disp/2009/230/15056_006.png

3.2.4.3 The deflagration density (Ddef) required to get the ignition during the test can be calculated as follows:

Imagen: img/disp/2009/230/15056_007.png

3.3 Aerosol Foam Product Flammability Test:

3.3.1 Introduction:

3.3.1.1 This standardized test describes the method for determining the flammability of an aerosol product dispensed in the form of foam, cream, gel or paste. The foam, cream, gel or paste of the spray is sprayed (about 5 g) on a watch glass, on the base of which a source of ignition is placed (candle, thin candle of wax, cerilla or tuft) to observe if ignition and combustion occurs. held. The ignition is defined by a stable flame that is maintained at least 2 s with a minimum height of 4 cm.

3.3.2 Instrumental and Material.

3.3.2.1 The following instrumental is required:

Graduate rule, support and clamp: Graduation in cm.

Fire-resistant watch glass of about 150 mm in diameter.

Stopwatch: Precision of ± 0.2 s.

Candle, thin wax, wax or lock.

Calibrated lab scales: Precision of ± 0.1 g.

Water Bath Kept at 20 ° C: Precision of ± 1 ° C.

Thermometer: Precision of ± 1 ° C.

Higrometer: Precision of ± 5%.

Gauge: Precision of ± 0.1 bar.

3.3.2.2 The watch glass is placed on a fire-resistant surface in an area without air current that can be ventilated after each test. The graduated rule is placed exactly behind the watch glass and is kept upright by means of a support and a clamp.

3.3.2.3 The rule is positioned so that its first stroke is level with the base of the watch glass in a horizontal plane.

3.3.3 Procedure:

3.3.3.1 General requirements:

3.3.3.1.1 Before testing, the aerosol dispenser shall be conditioned and primed by discharge for approximately 1 s. The purpose of this action is to remove the non-homogeneous material from the submerged tube.

3.3.3.1.2 The employment instructions will be strictly followed, in particular the instruction of whether the aerosol generator should be used in a vertical or inverted position. When it is necessary to shake it, it must be done immediately before the test.

3.3.3.1.3 The test shall be carried out in an environment without air current and which can be ventilated, with the temperature controlled at 20 ° C ± 5 ° C and a relative humidity of 30-80%.

3.3.3.2 Test Procedure:

a) A minimum of four aerosol generators filled with each product shall be conditioned at 20 ° C ± 1 ° C with at least 95% of the generator immersed in water for at least 30 minutes before each test (if the Spray is completely submerged, 30 minutes of conditioning will be sufficient).

b) Adjusting to general requirements. Log the temperature and relative humidity of the environment.

c) Determine internal pressure at 20 ° C ± 1 ° C (to remove defective or partially loaded aerosol dispensers).

d) Measure the discharge or flow rate of the aerosol product to be examined, so that the quantity of test product dispensed can be better calibrated.

e) Pesar one of the aerosol dispensers and note down their mass.

f) On the basis of the measured discharge or flow rate and following the manufacturer's instructions, discharge about 5 g of product in the centre of the clean watch glass to produce a 25 mm height mound such as maximum.

g) In the 5 s after the discharge, apply the ignition source to the edge of the sample by its base and simultaneously put in place the timer. If necessary, the ignition source of the edge of the sample shall be removed after approximately 2 s, in order to clearly observe whether the ignition has occurred. If no ignition of the sample is observed, the ignition source shall be reapplied to the edge of the sample.

h) If ignition occurs, proceed as follows:

i) to record the maximum flame height above the clock glass base, in cm,

ii) annotate the duration of the flame, in s,

iii) dry and re-weigh the aerosol generator, and calculate the mass of the released product.

i) Windows the test zone immediately after each test.

j) If ignition is not achieved and the product discharged remains in the form of foam or paste throughout the period of use, steps must be repeated (e) to (i). Wait 30 s, 1 minute, 2 minutes or 4 minutes before applying the ignition source to the product.

k) Repeat twice more (a total of three) steps e) to j) of the test procedure with the same package.

l) Repeat steps e) to k) of the test procedure with two other aerosol containers (three containers in total) of the same product.

3.3.4 Method of evaluating results:

3.3.4.1 A test report will be written that contains the following information:

a) if the product ignition has occurred;

b) the maximum flame height, in cm;

c) the duration of the flame, in s;

d) the mass of the product tested.