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ANNEX

1.   DEFINITIONS

1.1.   Pressures

‘Pressures’ means the internal pressures expressed in bars (relative pressures).

1.2.   Test pressure

‘Test pressure’ means the pressure to which an unfilled aerosol dispenser container may be subjected for 25 seconds without any leakage being caused or, in the case of metal or plastic containers, any visible or permanent distortion except as allowed under 6.1.1.2.

1.3.   Bursting pressure

‘Bursting pressure’ means the minimum pressure which causes the aerosol dispenser container to burst or rupture.

1.4.   Total capacity of the container

‘Total capacity of the container’ means the volume in millilitres of an open container up to the rim of the opening.

1.5.   Net capacity

‘Net capacity’ means the volume in millilitres of a filled and closed aerosol dispenser.

1.6.   Volume of liquid phase

‘Volume of liquid phase’ means the volume of the non-gaseous phases in the filled and closed aerosol dispenser.

1.7.   Test conditions

‘Test conditions’ means the values of test and bursting pressures exerted hydraulically at 20° C (± 5° C).

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1.7a.    Substance

‘Substance’ means substance as defined in Article 2(7) of Regulation (EC) No 1272/2008.

1.7b.    Mixture

‘Mixture’ means mixture as defined in Article 2(8) of Regulation (EC) No 1272/2008.

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1.8.   Flammable contents

Contents of aerosols shall be considered as flammable if they contain any component which is classified as flammable:

This definition does not cover pyrophoric, self-heating or water-reactive substances and mixtures, which shall never be components of aerosol contents.

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1.9.   Flammable aerosols

For the purpose of this Directive, an aerosol is considered as ‘non-flammable’, ‘flammable’ or ‘extremely flammable’ according to its chemical heat of combustion and mass content of flammable components, as follows:

1.9.1.   Flammable spray aerosols

In the case of spray aerosols the classification shall be made taking into account the chemical heat of combustion and on the basis of the results of the ignition distance test, as follows:

1.9.2.   Flammable foam aerosols

In the case of foam aerosols, the classification shall be made on the basis of the results of the foam flammability test.

1.10.   Chemical Heat of Combustion

The chemical heat of combustion ΔHc shall be either determined by:

The chemical heat of combustion (ΔHc), in kilojoules per gram (kJ/g), can be calculated as the product of the theoretical heat of combustion (ΔHcomb), and a combustion efficiency, usually less than 1,0 (a typical combustion efficiency is 0,95 or 95 %).

For a composite aerosol formulation, the chemical heat of combustion is the summation of the weighted heats of combustion for the individual components, as follows:

where:

ΔHc

=

chemical heat of combustion (kJ/g) of the product;

wi%

=

mass fraction of component i in the product;

ΔHc(i)

=

specific heat of combustion (kJ/g) of component i in the product.

The person responsible for the marketing of the aerosol dispenser has to describe the method used for determining the chemical heat of combustion in a document to be made readily available in an official Community language at the address specified on the label in accordance with point (a) of Article 8(1), if the chemical heat of combustion is used as a parameter for assessing the flammability of aerosols according to the provisions of this Directive.

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2.   GENERAL PROVISIONS

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Without prejudice to specific provisions of the Annex on requirements related to the flammability and pressure hazard, the person responsible for the marketing of aerosol dispensers is under an obligation to analyse the hazards in order to identify those which apply to his aerosol dispensers. Where appropriate, this analysis shall include a consideration of the risks resulting from the inhalation of the spray ejected by the aerosol dispenser under normal and reasonably foreseeable conditions of use, taking into account droplet size distribution in conjunction with physical and chemical properties of the contents. He must then design, construct and test it and, if applicable, draft special statements concerning its use, taking account of his analysis.

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2.1.   Construction and equipment

2.1.1.

The filled aerosol dispenser must be such that, under normal conditions of use and storage, it complies with the provisions of this Annex.

2.1.2.

The valve must enable the aerosol dispenser to be virtually hermetically sealed under normal conditions of storage or transport and must be protected, for example by means of a protective cap, against any unintentional opening and any deterioration.

2.1.3.

There must be no possibility that the mechanical resistance of the aerosol dispenser can be impaired by the action of the substances contained in it, even during prolonged storage.

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2.2.    Labelling

Without prejudice to Regulation (EC) No 1272/2008, each aerosol dispenser must visibly bear the following legible and indelible marking:

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2.3.    Volume of the liquid phase

The volume of the liquid phase at 50 °C must not exceed 90 % of the net capacity

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3.   SPECIAL PROVISIONS FOR METAL AEROSOL DISPENSERS

3.1.   Capacity

The total capacity of these containers may not exceed 1 000 ml.

3.1.1.   Test pressure of the container

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3.1.2.

The pressure at 50 °C in the aerosol dispenser must not exceed the values provided for in the following table, depending upon the content of gases in the aerosol dispenser: Content of gases Pressure at 50 °C Liquefied gas or mixture of gases having a flammable range with air at 20 °C and a standard pressure of 1,013 bar 12 bar Liquefied gas or mixture of gases not having a flammable range with air at 20 °C and a standard pressure of 1,013 bar 13,2 bar Compressed gases or gases dissolved under pressure not having a flammable range with air at 20 °C and a standard pressure of 1,013 bar 15 bar

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4.   SPECIAL PROVISIONS FOR GLASS AEROSOL DISPENSERS

4.1.   Plastic coated or permanently protected containers

Containers of this type may be used for filling with compressed, liquefied or dissolved gas.

4.1.1.   Capacity

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

4.1.2.   Coating

The coating must be a protective envelope of plastic or other suitable material, intended to prevent the risk of flying particles of glass if the container is accidently broken, and must be so designed that there are no flying particles of glass if the filled aerosol dispenser, brought to a temperature of 20° C, is dropped from a height of 1·8 m onto a concrete floor.

4.1.3.   Test pressure of the container

4.1.4.   Filling

This table shows the pressure limits permitted at 20° C in relation to the percentage of gas.

Pressure limits for percentages of gas not shown in the table shall be extrapolated from it.

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4.2.   Unprotected glass containers

Aerosol dispensers using unprotected glass containers shall be filled exclusively with liquefied or dissolved gases.

4.2.1.   Capacity

The total capacity of these containers may not exceed 150 ml.

4.2.2.   Test pressure of the container

The test pressure of the container must be equal to at least 12 bars.

4.2.3.   Filling

This table shows the pressure limits permitted at 20° C in relation to the percentage of liquefied gas.

Pressure limits for percentages of gas not shown in the table shall be extrapolated from it.

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5.   SPECIAL PROVISIONS APPLYING TO PLASTIC AEROSOL DISPENSERS

5.1.	Plastic aerosol dispensers which may splinter on bursting shall be treated in the same way as unprotected glass aerosol dispensers.

5.2.	Plastic aerosol dispensers which cannot splinter on bursting shall be treated in the same way as glass aerosol dispensers with a protective coating.

6.   TESTS

6.1.   Test requirements to be guaranteed by the person responsible for marketing

6.1.1.   Hydraulic test on empty containers

6.1.1.1.

Metal, glass or plastic aerosol dispensers must be able to withstand a hydraulic pressure test as laid down in 3.1.1, 4.1.3 and 4.2.2.

6.1.1.2.

Metal containers showing assymetrical or major distortions or other similar faults shall be rejected. A slight symmetrical distortion of the base or one affecting the profile of the upper casing shall be allowed provided that the container passes the bursting test.

6.1.2.   Bursting test for empty metal containers

The person responsible for marketing must ensure that the bursting pressure of containers is at least 20 % higher than the test pressure laid down.

6.1.3.   Dropping test for protected glass containers

The manufacturer must ensure that the containers satisfy the test requirements laid down in 4.1.2.

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6.1.4.   Final inspection of filled aerosol dispensers

6.1.4.1.

Aerosol dispensers shall be subject to one of the following final test methods. (a)   Hot water bath test Each filled aerosol dispenser shall 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 that which would be exerted by its contents at a uniform temperature of 50 °C. (ii)  Any aerosol dispenser showing visible permanent distortion or a leak must be rejected. (b)   Hot final test methods Other methods for heating the contents of aerosol dispensers may be used if they guarantee that the pressure and temperature in each filled aerosol dispenser reach the values required for the hot water bath test and distortions and leaks are detected with same precision as in the case of the hot water bath test. (c)   Cold final test methods An alternative cold final test method may be used if it is in accordance with the provisions of an alternative method to the hot water bath test for aerosol dispensers specified in point 6.2.4.3.2.2 of Annex A to Directive 94/55/EC.

6.1.4.2.

For aerosol dispensers the contents of which undergo a physical or chemical transformation changing their pressure characteristics after filling and before first use, cold final test methods according to point 6.1.4.1(c) should be applied.

6.1.4.3.

In case of test methods according to points 6.1.4.1(b) and 6.1.4.1(c): (a)  The test method must be approved by a competent authority. (b)  The person responsible for the marketing of aerosol dispensers must submit an application for approval to a competent authority. The application must be accompanied by the technical file describing the method. (c)  The person responsible for the marketing of aerosol dispensers must, for surveillance purposes, keep the approval of the competent authority, the technical file describing the method and, if applicable, control reports readily available at the address specified on the label in accordance with point (a) of Article 8(1). (d)  The technical file must be established in an official Community language or a certified copy thereof must be available. (e)  ‘competent authority’ means the authority designated in each Member State under Directive 94/55/EC.

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6.2.   Examples of inspection tests which may be carried out by Member States

6.2.1.   Test on unfilled containers

The test pressure shall be applied for 25 seconds on five containers selected at random from a homogeneous batch of 2 500 unfilled containers, i.e. manufactured from the same materials by the same continuous batch manufacturing process, or from a batch constituting one hour's production.

If any one of these containers does not pass the test, ten additional containers shall be drawn at random from the same batch and put through the same test.

If any one of these aerosol containers does not pass the test, the whole batch shall be unsuitable for use.

6.2.2.   Tests on filled aerosol dispensers

Air and water-tightness inspection tests shall be carried out by immersing a representative number of filled aerosol dispensers in a bath of water. The temperature of the bath and the period of immersion must be such as to enable the contents of the aerosol dispenser to attain a uniform temperature of 50° C during the time required to ensure that there is no bursting or rupture.

Any batch of aerosol dispensers which does not pass these tests must be considered unsuitable for use.

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6.3.   Tests on the flammability of aerosols

6.3.1.   Ignition distance test for spray aerosols

6.3.1.1.   Introduction

6.3.1.2.   Apparatus and material

6.3.1.3.   Procedure

6.3.1.3.1.   General requirements

6.3.1.3.2.   Test procedure

6.3.1.3.2.1.

All experiments shall be performed in a fume hood in a room that may be well ventilated. Ventilation of the fume hood and room can be applied for at least three minutes after each test. Take all necessary safety precautions to prevent the inhalation of combustion products.

6.3.1.3.2.2.

The cans with a 10-12 % nominal fill level shall be tested only once. The result tables need only one result per can indicated.

6.3.1.3.2.3.

When the test in the position in which the dispenser is designed to be used gives a negative result, the test shall be repeated in the position of the dispenser most likely to result in a positive result.

6.3.1.4.   Method of assessing results

6.3.1.4.1.

All the results shall be recorded. Table 6.3.1.1 below shows the model of ‘result table’ to be used. Table 6.3.1.1 Date Temperature … °C Relative humidity … % Name of product   Net volume   Can 1 Can 2 Can 3 Initial level of filling   % % % Dispenser distance Test 1 2 3 1 2 3 1 2 3 15 cm Ignition? Y or N       30 cm Ignition? Y or N       45 cm Ignition? Y or N       60 cm Ignition? Y or N       75 cm Ignition? Y or N       90 cm Ignition? Y or N       Observations — including can position

6.3.2.   Enclosed space ignition test

6.3.2.1.   Introduction

This test standard describes the method to assess the flammability of products emerging from aerosol dispensers due to their propensity to ignite in an enclosed or confined space. The contents of an aerosol dispenser are sprayed into a cylindrical test vessel containing a burning candle. If an observable ignition occurs, the elapsed time and amount discharged is noted.

6.3.2.2.   Apparatus and material

6.3.2.2.1.

The following apparatus is required: Chronometer (stopwatch) accurate to ± 0,2 s Water bath maintained at 20 °C accurate to ± 1 °C Calibrated laboratory scales (balance) accurate to ± 0,1 g Thermometer accurate to ± 1 °C Hygrometer accurate to ± 5 % Pressure gauge accurate to ± 0,1 bar Cylindrical test vessel as detailed below

6.3.2.2.2.

Preparation of test apparatus 6.3.2.2.2.1. A cylindrical vessel approximately 200 dm3 volume, approximately 600 mm in diameter and approximately 720 mm long and open at one end shall be modified as follows: (a)  A closure system consisting of a hinged cover shall be matched to the open end of the receptacle; or (b)  A plastic film 0,01 to 0,02 mm thick may be used as a closure system. If the test is carried out with a plastic film this must be used as described below: Stretch the film over the open end of the drum and hold it in place with an elastic band. The strength of the band shall be such that when placed around the drum resting on its side, it stretches by only 25 mm when a mass of 0,45 kg is attached to its lowest point. Cut a 25 mm slit in the film, starting 50 mm from the edge of the drum. Ensure that the film is taut; (c)  At the other end of the drum drill a 50 mm diameter hole 100 mm from the edge in such a way that the orifice is uppermost when the receptacle is laid down and ready for the test (Figure 6.3.2.1.); Figure 6.3.2.1 (d)  On a 200 × 200 mm metal support place a paraffin wax candle 20 to 40 mm in diameter and 100 mm high. The candle shall be replaced when having a height of less than 80 mm. The candle's flame is protected from the action of the spray by a 150 mm wide, 200 mm high deflector. This includes the plane inclined at 45° produced 150 mm from the base of the deflector (Figure 6.3.2.2.); Figure 6.3.2.2 (e)  The candle placed on the metal support shall be positioned midway between the two ends of the drum (Figure 6.3.2.3); Figure 6.3.2.3 (f)  The drum is laid on the ground or on a support at a spot where the temperature is between 15 °C and 25 °C. The product to be tested will be sprayed within the drum of roughly 200 dm3 in which there will be a source of ignition. 6.3.2.2.2.2. Usually, the product leaves the aerosol can at an angle of 90° relevant to the vertical axis of the can. The layout and procedure described refers to this kind of aerosol product. In the case of unusually operating aerosols (e.g. vertical-spray aerosol dispensers) it will be necessary to record changes to equipment and procedures in accordance with good laboratory practice, such as ISO/IEC 17025:1999 General requirements for the competence of testing and calibration laboratories.

6.3.2.3.   Procedure

6.3.2.3.1.   General requirements

6.3.2.3.2.   Test procedure

6.3.2.4.   Method of assessing results

6.3.2.4.1.

A test report containing the following information shall be drawn up: (a)  The product tested and its references; (b)  The internal pressure and discharge rate of the aerosol dispenser; (c)  The temperature and relative air humidity of the room; (d)  For each test, the discharge time (s) needed to achieve ignition (if the product does not ignite, state this); (e)  The mass of the product sprayed during each test (in g); (f)  The actual volume of the drum (in dm3).

6.3.2.4.2.

The time equivalent (teq) needed to achieve ignition in one cubic metre can be calculated as follows:

6.3.2.4.3.

The deflagration density (Ddef) needed to achieve ignition during the test may also be calculated as follows:

6.3.3.   Aerosol foam flammability test

6.3.3.1.   Introduction

6.3.3.1.1.

This test standard describes the method to determine the flammability of an aerosol spray emitted in the form of a foam, mousse, gel or paste. An aerosol, which emits a foam, mousse, gel or paste is sprayed (approximately 5 g) on a watchglass and an ignition source (candle, wax taper, match or lighter) is placed at the base of the watchglass to observe if ignition and sustained combustion of the foam, mousse, gel or paste occurs. Ignition is defined as a stable flame maintained for at least two seconds and a minimum 4 cm in height.

6.3.3.2.   Apparatus and material

6.3.3.2.1.

The following apparatus is required: Graduated scale, support and clamp gradations in cm Fire-resistant watchglass roughly 150 mm in diameter   Chronometer (stopwatch) accurate to ± 0,2 s Candle, wax taper, match or lighter   Calibrated laboratory scales (balance) accurate to ± 0,1 g Water bath maintained at 20 °C accurate to ± 1 °C Thermometer accurate to ± 1 °C Hygrometer accurate to ± 5 % Pressure gauge accurate to ± 0,1 bar

6.3.3.2.2.

The watchglass is placed on a fire-resistant surface within a draught-free area that may be ventilated after each test. The graduated scale is positioned exactly behind the watchglass and held vertically by means of a support and clamp.

6.3.3.2.3.

The scale is positioned in such a way that its origin is on a level with the watchglass base in a horizontal plane.

6.3.3.3.   Procedure

6.3.3.3.1.   General requirements

6.3.3.3.2.   Test procedure

6.3.3.4.   Method of assessing results

6.3.3.4.1.

A test report containing the following information shall be drawn up: (a)  whether the product ignites; (b)  maximum flame height in cm; (c)  duration of flame in s; (d)  the mass of the product tested.