AEROSOL DISPENSERS REGULATIONS

AEROSOL DISPENSERS

SUBSIDIARY LEGISLATION 427.26

AEROSOL DISPENSERS REGULATIONS

1st July, 2002

LEGAL NOTICE 145 of 2002, as amended by Legal Notices 26 of 2009,

94 of 2011, 395 of 2013 and 93 of 2017.

1. The title of these regulations is the Aerosol Dispensers

Regulations.

1.2. These regulations shall become operative on the 1st July,

2002

Provided that the requirements to provide information to

the European Commission referred to in regulation 7.3 shall come

into force on such date as the Minister responsible for Consumer

Affairs, after consultation with the Malta Standards Authority, may

prescribe. *

Amended by

L.N. 26 of 2009;

Based on the Annex of the Directive

L.N. 395 of 2013;

L.N. 93 of 2017.

1. DEFINITIONS

1.1. Pressures

'Pressures' means the internal pressures 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 point 6.1.1.2 of this Schedule.

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 millimetres of an open

container up to the rim of the opening.

1.5. Net capacity

'Net capacity' means the volume in millimetres of a filled and closed aerosol

dispenser.

1.6. Volume of the 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 the test and bursting pressures exerted

hydraulically at 20ºC (± 5ºC).

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.

1.8. Flammable contents

Contents of aerosols shall be considered as flammable if they contain any

component which is classified as flammable

1.8.1

flammable liquid means a liquid having a flashpoint of not more

than 93°C;

1.8.2

flammable solid means a solid substance or mixture which is readily

combustible, or may cause or contribute to fire as a result of

friction. Readily combustible solids are powdered, granular, or

pasty substances or mixtures which are dangerous if they can be

easily ignited by brief contact with an ignition source, such as a

AEROSOL DISPENSERS

burning match, and if the flame spreads rapidly; and

flammable gas means a gas or gas mixture having a flammable

range with air at 20°C and a standard pressure of 1,013 bar;

This definition does not cover pyrophoric, self-heating or water-reactive

substances and mixtures, which shall never be components of aerosol contents.

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

(a) the aerosol is classified as "extremely flammable" if it contains 85% or

more flammable components and the chemical heat of combustion

exceeds or is equal to 30 kJ/g;

(b) the aerosol is classified as "non-flammable" if it contains 1% or less

flammable components and the chemical heat of combustion is less than

20 kJ/g; and

(c) all other aerosols will be submitted to the following flammability

classification procedures or shall be classified as "extremely

flammable". The ignition distance test, the enclosed space test and the

foam flammability test shall comply with point 6.3.

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

1.9.1.1

If the chemical heat of combustion is less than 20 kJ/g

1.9.1.1.1

the aerosol is classified as "flammable" if

ignition occurs at a distance equal or greater

than 15 cm but less than 75 cm;

1.9.1.1.2

the aerosol is classified as "extremely

flammable" if ignition occurs at a distance of

75 cm or more; and

1.9.1.1.3

if no ignition occurs in the ignition distance

test, the enclosed space test shall be

performed and in this case, the aerosol is

classified as "flammable" if the time

equivalent is less than or equal to 300 s/m3 or

the deflagration density is less than or equal

to 300 g/m3; otherwise the aerosol is

classified as "non-flammable".

1.9.1.2

If the chemical heat of combustion is equal to or more

than 20 kJ/g, the aerosol is classified as "extremely

flammable" if ignition occurs at a distance of 75 cm or

more; otherwise the aerosol is classified as "flammable".

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.

1.9.2.1

The aerosol product shall be classified as "extremely

flammable" if

1.9.2.1.1

the flame height is 20 cm or more and the

flame duration is two seconds or more; or

1.9.2.1.2

the flame height is 4 cm or more and the

flame duration is seven seconds or more.

1.9.2.2

The aerosol product which does not meet the criteria in

(a) is classified as "flammable" if the flame height is 4 cm

or more and the flame duration is two seconds or more.

1.10. Chemical Heat of Combustion

The chemical heat of combustion ΔHc shall be either determined by

1.10.1

acknowledged rules of technology, described e.g. in standards such

as ASTM D 240, ISO 13943 86.1 to 86.3 and NFPA 30B, or found

in the scientifically established literature; or

1.10.2

applying the following calculation method

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

n



[w i %  ΔH C(i) ]

ΔH c =

i

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 shall 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 5.2.1 of regulation 5.2, if the chemical heat of

combustion is used as a parameter for assessing the flammability of aerosols

according to the provisions of this regulation.

2. GENERAL PROVISIONS

2.0 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.

2.1. Construction and equipment

AEROSOL DISPENSERS

The filled aerosol dispenser must be such that, under normal

conditions of use and storage, it complies with the provisions of this

Schedule.

The value must enable the aerosol 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.

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.

2.2. Labelling

Without prejudice to Regulation (EC) No 1272/2008, each aerosol dispenser

must visibly bear the following legible and indelible marking

(a) where the aerosol is classified as ‘non-flammable’ according to the

criteria of point 1.9, the signal word ‘Warning’ and the other label

elements for Aerosols Category 3 provided for in Table 2.3.1 of Annex I

to Regulation (EC) No 1272/2008;

(b) where the aerosol is classified as ‘flammable’ according to the criteria

of point 1.9, the signal word ‘Warning’ and the other label elements for

Aerosols Category 2 provided for in Table 2.3.1 of Annex I to

Regulation (EC) No 1272/2008;

(c) where the aerosol is classified as ‘extremely flammable’ according to

the criteria of point 1.9, the signal word ‘Danger’ and the other label

elements for Aerosols Category 1 provided for in Table 2.3.1 of Annex I

to Regulation (EC) No 1272/2008;

(d) where the aerosol dispenser is a consumer product, the precautionary

statement P102 provided for in Part 1, Table 6.1 of Annex IV to

Regulation (EC) No 1272/2008;

(e) any additional operating precautions which alert consumers to the specific

dangers of the product; if the aerosol dispenser is accompanied by separate

instructions for use, the latter must also reflect such operating precautions.

2.3. Volume of the liquid phase

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

3. SPECIAL PROVISION 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 containers

(a) For containers filled with a pressure of less than 6.7 bars at

50ºC, the test pressure must be equal to at least 10 bars.

(b) For containers filled at a pressure equal to or greater than 6.7

bars at 50ºC, the test pressure must be 50% higher than the

internal pressure at 50ºC.

3.1.2. Filling

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

Pressure at

Content of gases

50°C

Liquefied gas or mixture of gases having a

flammable range with air at 20°C and a standard

12 bar

pressure of 1,013 bar

Liquefied gas or mixture of gases not having a

flammable range with air at 20°C and a standard

13,2 bar

pressure of 1,013 bar

Compressed gases or gases dissolved under

pressure not having a flammable range with air at

15 bar

20°C and a standard pressure of 1,013 bar

4. SPECIAL PROVISIONS FOR GLASS AEROSOL DISPENSERS

4.1. Plastic coated or permanently protected containers

Containers of this type may be used for filling compressed, liquefied or

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

the glass if the container is accidentally broken, and must be so

designed that there are no flying particles of glass if the filled

aerosol dispenser, brought to a temperature of 20ºC, is dropped from

a height of 1.8 m onto a concrete floor.

4.1.3. Test pressure of container

(a) Containers used for filling with compressed or dissolved gas

must resist a test pressure equal to at least 12 bars.

(b) Containers used for filling with liquefied gas must resist a test

pressure equal to at least 12 bars.

4.1.4. Filling

(a) Aerosol dispensers filled with compressed gas shall not be

required to withstand a pressure of more than 9 bars at 50ºC.

(b) Aerosol dispensers filled with dissolved gas shall not be

required to withstand a pressure of more than 8 bars at 50ºC.

(c) Aerosol dispensers containing liquefied gas or mixtures of

liquefied gas shall not be required to withstand, at 20ºC, at

pressure higher than those shown in the following table

Percentage weight of liquefied gas in

the total mixture

Total capacity

20%

50%

80%

50 to 80 ml

3.5 bars

2.8 bars

2.5 bars

< 80 to 160 ml

3.2 bars

2.5 bars

2.2 bars

< 160 to 220 ml

2.8 bars

2.1 bars

1.8 bars

AEROSOL DISPENSERS

This table shows the pressure limits permitted at 20ºC in relation to

the percentage of gas.

Pressure limits for percentages of gas not shown in the table shall be

extrapolated from it.

4.2. Unprotected glass containers

Aerosol dispensers using unprotected glass 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

(a) Aerosol dispensers filled with dissolved gas shall not be

required to withstand a pressure of more than 8 bars at 50ºC.

(b) Aerosol dispenser containing liquefied gas shall not be

required to withstand, at 20ºC, pressure in excess of those

shown down in the following table

Percentage weight of liquefied gas in

the total mixture

Total capacity

20%

50%

80%

50 to 70 ml

1.5 bar

1.5 bar

1.25 bar

< 70 to 150 ml

1.5 bar

1.5 bars

1 bar

This table shows the pressure limits permitted at 20ºC in relation to

the percentage of liquefied gas.

Pressure limits for percentages of gas not shown in the table shall be

extrapolated from it.

5. SPECIAL

PROVISION

APPLYING

TO

PLASTIC

AEROSOL

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 points

3.1.1, 4.1.3 and 4.2.2 of this Schedule.

6.1.1.2. Metal containers showing asymmetrical 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 point 4.1.2 of this Schedule.

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.

6.1.4.1.1

Hot water bath test

Each filled aerosol dispenser

shall

be

immersed in a hot water bath.

6.1.4.1.1.1

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.

6.1.4.1.1.2

Any aerosol dispenser showing

visible permanent distortion or a

leak must be rejected.

6.1.4.1.2

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.

6.1.4.1.3

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 6.1.4.1.3

should be applied.

6.1.4.3. In case of test methods according to points 6.1.4.1.2 and

6.1.4.1.3

6.1.4.3.1

The test method must be approved by a

competent authority.

6.1.4.3.2

The person responsible for the marketing of

AEROSOL DISPENSERS

aerosol

dispensers

must

submit

an

application for approval to a competent

authority.

The

application

must

be

accompanied by the technical file describing

the method.

6.1.4.3.3

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 5.2.1 of

regulation 5.2.

6.1.4.3.4

The technical file must be established in an

official Community language or a certified

copy thereof must be available.

6.1.4.3.5

"competent authority" means the authority

designated in each Member State under

Directive 94/55/EC.

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 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 aerosols 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 test 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 musk be such as to enable the contenks of the aerosol

dispenser to attain a uniform temperature of 50ºC 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.

6.3. Tests on the flammability of aerosols

6.3.1. Ignition distance test for spray aerosols

6.3.1.1. Introduction

6.3.1.1.1. This test standard describes the method to

determine the ignition distance of an aerosol

spray in order to assess the associated flame

risk. The aerosol is sprayed in the direction

of an ignition source at intervals of 15 cm to

observe if ignition and sustained combustion

of the spray takes place. Ignition and

sustained combustion is defined as when a

stable flame is maintained for at least five

seconds. The ignition source is defined as a

gas burner with a blue, non-luminous flame

4-5 cm in height.

6.3.1.1.2. 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 dispensing foams,

mousses, gels and pastes or fitted with a

metering valve, are excluded from this test.

Aerosol products that dispense foams,

mousses, gels or pastes are subject to testing

under the aerosol foam flammability test.

6.3.1.2. Apparatus and material

6.3.1.2.1. The following apparatus is required

Water bath maintained at 20°C

accurate to ± 1°C

Calibrated laboratory scales

(balance)

accurate to ± 0,1 g

Chronometer (stopwatch)

accurate to ± 0,2 s

Graduated scale, support and

clamp

graduations in cm

Gas burner with support and clamp

Thermometer

accurate to ± 1°C

Hygrometer

accurate to ± 5%

Pressure gauge

accurate to ± 0,1 bar

6.3.1.3. Procedure

6.3.1.3.1. General requirements

6.3.1.3.1.1. Before testing, each aerosol

dispenser shall be conditioned

and then primed by discharging

for approximately one second.

The purpose of this action is to

remove

non-homogeneous

material from the diptube.

6.3.1.3.1.2. The instructions of use shall be

strictly followed, including

whether the

dispenser is

intended to be used in the

upright or inverted position.

When shaking is required, shake

immediately before testing.

6.3.1.3.1.3. The test shall be carried out in a

draught-free

environment

capable of ventilation, with the

temperature controlled at 20°C

AEROSOL DISPENSERS

± 5°C and relative humidity in

the range 30-80.

6.3.1.3.1.4. Each aerosol dispenser is to be

tested

(a) when full according to the

complete procedure, with

the gas burner in the range

of 15-90 cm distance from

the actuator of the aerosol

can;

(b) when 10-12% full nominal

(% by mass) only one test,

either at 15 cm distance

from the actuator when the

spray from a full can did

not ignite at all, or at the

flame ignition distance of

the spray of a full can plus

15 cm.

6.3.1.3.1.5. During the test, the can shall be

positioned as indicated by label

instructions. The ignition source

shall be positioned accordingly.

6.3.1.3.1.6. The

following

procedure

requires testing the spray at

intervals of 15 cm between the

burner flame and the aerosol

actuator, in the range of 15-90

cm. It is efficient to start at 60

cm distance between burner

flame and aerosol actuator. The

distance between burner flame

and aerosol actuator shall be

increased by 15 cm in the case

of an ignition of the spray at 60

cm distance. The distance shall

be decreased by 15 cm in the

case of no ignition at 60 cm

distance between burner flame

and aerosol actuator. The aim of

the procedure is to determine

the maximum distance between

aerosol actuator and burner

flame that leads to sustained

combustion of the spray or to

determine that ignition could

not be obtained at 15 cm

distance between the burner

flame and the aerosol’s actuator.

6.3.1.3.2. Test procedure

(a) a minimum of 3 full aerosol dispensers

per product shall be conditioned to 20°C

± 1°C with at least 95 % of the dispenser

immersed in the water for at least 30 min

before each test (if the aerosol is fully

immersed, 30 min conditioning is

sufficient);

(b) comply with general requirements.

Record the temperature and relative

humidity of the environment;

(c) weigh an aerosol dispenser and note its

mass;

(d) determine the internal pressure and

initial discharge rate at 20°C ± 1°C (to

eliminate faulty or partly filled aerosol

dispensers);

(e) support the gas burner on a flat

horizontal surface or fix the burner to a

support by means of a clamp;

(f) ignite the gas burner; the flame shall be

non-luminous and approximately 4-5 cm

high;

(g) place the actuator’s exit orifice at the

required distance from the flame. The

aerosol shall be tested in the position it is

designed to be used, e.g. upright or

inverted;

(h) level the actuator's orifice and burner

flame, ensuring that the orifice is

properly directed towards and aligned

with the flame (see Figure 6.3.1.1). The

spray shall be expelled through the top

half of the flame;

Figure 6.3.1.1

(i) comply with the general requirements

regarding shaking of the dispenser;

(j) actuate the valve of the aerosol

dispenser, to discharge its contents for

five seconds, unless ignition occurs. If

ignition occurs, continue discharging and

time the duration of the flame for five

seconds, from the start of ignition;

(k) note the ignition results for the distance

between the gas burner and the aerosol

dispenser in the table provided;

AEROSOL DISPENSERS

(l) if no ignition occurs during step (j), the

aerosol shall be tested in alternative

orientations, e.g. inverted for upright use

products, to check if ignition is obtained;

(m) repeat steps (g) to (l) twice more (a total

of 3) for the same can at the same

distance between the gas burner and the

aerosol actuator;

(n) repeat the test procedure for another two

aerosol cans of the same product at the

same distance between gas burner and

aerosol actuator;

(o) repeat steps (g) to (n) of the test

procedure at a distance between 15 and

90 cm between the actuator of the aerosol

can and the burner flame depending on

the outcome of each test (see also

6.3.1.3.1.4 and 6.3.1.3.1.5);

(p) if no ignition occurs at 15 cm, the

procedure is finished for initially full

cans. The procedure is also finished

when ignition and sustained combustion

is obtained at a distance of 90 cm. If

ignition could not be obtained at 15 cm

distance, record that ignition did not

occur. The maximum distance between

burner flame and the aerosol’s actuator

for which an ignition and sustained

combustion was observed is noted as the

"ignition distance", in all other

circumstances;

(q) one test shall also be conducted on three

cans of 10-12% nominal fill level. These

cans shall be tested at a distance between

the aerosol’s actuator and the burner

flame of the ‘flame ignition distance of

full cans + 15 cm’;

(r) discharge an aerosol can to a 10-12%

nominal fill level (by mass) in bursts of

30 seconds maximum. Observe a 300

seconds minimum time period between

bursts. During this interim period

dispensers shall be placed in the water

bath for conditioning;

(s) repeat steps (g) to (n) for 10-12%

nominal fill aerosol cans, omitting steps

(l) and (m). This test shall only be

performed with the aerosol in one

position, e.g. upright or inverted,

corresponding with that which produced

the ignition (if any) for filled cans; and

(t) record all results in the Table 6.3.1.1 as

shown below.

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

Relevant humidity ....... %

Name of product

Net volume

Can 1

Can 2

Can 3

Initial level

of filling

D i s p e n s e r Test

1 2 3

distance

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

AEROSOL DISPENSERS

Observa-

tions

-

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 bar

accurate to ± 0,1

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

6.3.2.2.2.1.1 a closure system

consisting of a

hinged cover shall

be matched to the

open end of the

receptacle; or

6.3.2.2.2.1.2 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; or

6.3.2.2.2.1.3 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

6.3.2.2.2.1.4 on a 200  200

mm metal support

place a paraffin

wax candle 20 to

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

AEROSOL DISPENSERS

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

6.3.2.2.2.1.5 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

6.3.2.2.2.1.6 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

6.3.2.3.1.1. Before testing, each aerosol

dispenser shall be conditioned

and then primed by discharging

for approximately 1 second. The

purpose of this action is to

remove

non-homogeneous

material from the diptube.

6.3.2.3.1.2. The instructions of use shall be

strictly

followed,

including

whether

the

dispenser

is

intended to be used in the

upright or inverted position.

When shaking is required, shake

immediately before testing.

6.3.2.3.1.3. The tests shall be carried out in a

draught-free

environment

capable of ventilation, with the

temperature controlled at 20°C ±

5°C and relative humidity in the

range 30-80%.

6.3.2.3.2. Test procedure

6.3.2.3.2.1 a minimum of 3 full aerosol

dispensers per product shall be

conditioned to 20°C ± 1°C in a

water bath with at least 95% of

the dispenser immersed in the

water for at least 30 min (if the

aerosol is fully immersed, 30

min conditioning is sufficient);

6.3.2.3.2.2 measure or calculate the actual

volume of the drum in dm3;

AEROSOL DISPENSERS

6.3.2.3.2.3 comply

with

general

requirements.

Record

the

temperature

and

relative

humidity of the environment;

6.3.2.3.2.4 determine the internal pressure

and initial discharge rate at 20°C

± 1°C (to eliminate faulty or

partly filled aerosol dispensers);

6.3.2.3.2.5 weigh one of the aerosol

dispensers and note its mass;

6.3.2.3.2.6 light the candle and apply the

closure system (cover or plastic

film);

6.3.2.3.2.7 place the aerosol dispenser

actuator orifice 35 mm or closer

for a wide spray product, from

the centre of the entrance hole in

the drum. Start the chronometer

(stopwatch) and following the

instructions for use of the

product; direct the spray towards

the centre of the opposite

extremity (cover or plastic film).

The aerosol shall be tested in the

position it is designed to be

used, e.g. upright or inverted;

6.3.2.3.2.8 spray until ignition occurs. Stop

the chronometer and note the

time elapsed. Re-weigh the

aerosol dispenser and note its

mass;

6.3.2.3.2.9 ventilate and clean the drum

removing any residue likely to

affect subsequent tests. Allow

the drum to cool if necessary;

and

6.3.2.3.2.10 repeat the test procedure steps

6.3.2.3.2.4 to 6.3.2.3.2.9 for

another two aerosol dispensers

of the same product (three in

total, note: each dispenser is

only tested once);

6.3.2.4. Method of assessing results

6.3.2.4.1. A test report containing the following

information shall be drawn up

6.3.2.4.1.1 the product

tested

and

its

references;

6.3.2.4.1.2 the internal

pressure and

discharge rate of the aerosol

dispenser;

6.3.2.4.1.3 the temperature and relative air

humidity of the room;

6.3.2.4.1.4 for each test, the discharge

time(s) needed to achieve

ignition (if the product does not

ignite, state this);

6.3.2.4.1.5 the mass of the product sprayed

during each test (in g);

6.3.2.4.1.6 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

1 000  discharge time(s)

teq =

Actual volume of drum (dm 3 )

6.3.2.4.3

The deflagration density (Ddef) needed to

achieve ignition during the test may also be

calculated as follows

1 000  Amount of product dispensed

Ddef =

Actual volume of drum (dm 3 )

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%

AEROSOL DISPENSERS

Pressure gauge bar

accurate to ± 0,1

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

6.3.3.3.1.1. Before testing, each aerosol

dispenser shall be conditioned

and then primed by discharging

for approximately 1 second. The

purpose of this action is to

remove

non-homogeneous

material from the diptube.

6.3.3.3.1.2. The instructions of use shall be

strictly

followed,

including

whether

the

dispenser

is

intended to be used in the

upright or inverted position.

When shaking is required, shake

immediately before testing.

6.3.3.3.1.3. The tests shall be carried out in a

draught-free

environment

capable of ventilation, with the

temperature controlled at 20°C ±

5°C and relative humidity in the

range of 30-80%.

6.3.3.3.2

Test procedure

6.3.3.3.2.1 a minimum of four full aerosol

dispensers per product shall be

conditioned to 20°C ± 1°C with

at least 95% of the dispenser

immersed in the water for at

least 30 min before each test (if

the aerosol is fully immersed, 30

min conditioning is sufficient);

6.3.3.3.2.2 comply

with

general

requirements.

Record

the

temperature

and

relative

humidity of the environment;

6.3.3.3.2.3 determine the internal pressure

at 20°C ± 1°C (to eliminate

faulty or partly filled aerosol

dispensers);

6.3.3.3.2.4 measure the discharge or flow

rate of the aerosol product to be

examined, so that the amount of

test product dispensed can be

more accurately gauged;

6.3.3.3.2.5 weigh one of the aerosol

dispensers and note its mass;

6.3.3.3.2.6 on the basis of the measured

discharge or flow rate and

following the manufacturer’s

instructions,

release

approximately 5 g of the product

onto the centre of the clean

watchglass with the aim of

producing a mound no higher

than 25 mm;

6.3.3.3.2.7 within

five

seconds

of

completion of discharge, apply

the source of ignition to the edge

of the sample at its base and at

the same time start the

chronometer (stopwatch). If

necessary, the ignition source

shall be removed from the edge

of

the

sample

after

approximately two seconds, in

order to clearly observe if

ignition has occurred. If no

ignition of the sample is

apparent, the ignition source

shall be reapplied to the edge of

the sample;

6.3.3.3.2.8 if ignition occurs

note

the

following points

6.3.3.3.2.8.1 the

maximum

height

of

the

flame in cm above

the base of the

watchglass;

6.3.3.3.2.8.2 the

flame

duration in s; and

6.3.3.3.2.8.3 dry and re-weigh

the

aerosol

dispenser

and

calculate the mass

of the released

product;

6.3.3.3.2.9

ventilate the test

area immediately

after each test;

6.3.3.3.2.10

if ignition is not

obtained and the

AEROSOL DISPENSERS

released product

remains in the

form of a foam or

paste throughout

its period of use,

steps (e) to (i)

shall be repeated.

Allow the product

to stand for 30

sec, 1 min, 2 min

or 4 min before

applying

the

ignition source;

6.3.3.3.2.11

repeat the test

procedure steps

(e) to (j) twice

more (a total of 3)

for the same can;

and

6.3.3.3.2.12

repeat the test

procedure steps

(e) to (k) for

another

two

aerosol cans (3

cans in total) of

the same product.

6.3.3.4. Method of assessing results

6.3.3.4.1. A test report containing the following

information shall be drawn up

6.3.3.4.1.1 whether the product ignites;

6.3.3.4.1.2 maximum flame height in cm;

6.3.3.4.1.3 duration of flame in s; and if

6.3.3.4.1.4 the mass of the product was

tested.

1. These regulations shall apply to aerosol dispensers as

d efin ed in reg ulatio n 3 , wit h th e ex ceptio n o f th os e with a

maximum capacity of less than 50 ml, and those with a maximum

capacity greater than that specified in points 3.1, 4.1.1, 4.2.1, 5.1

and 5.2 respectively of the Annex of the Directive, which is set out

in the Schedule.

2.2. These regulations implement the provisions of Commission

Directive 2013/10/EU of 19 March 2013 amending Council Directive

75/324/EEC on the approximation of the laws of the Member States

relating to aerosol dispensers in order to adapt its labelling provisions

to Regulation (EC) No 1272/2008 of the European Parliament and of

the Council on classification, labelling and packaging of substances

and mixtures.

2.3 These regulations transpose Commission Directive 2016/2037

of 21 November 2016 amending Council Directive 75/324/EEC as

regards the maximum allowable pressure of aerosol dispensers and to

adapt its labelling provisions to Regulation (EC) No 1272/2008 of the

European Parliament and of the Council on classification, labelling and

packaging of substances and mixtures."

1. For the purposes of these regulations, the following

definitions shall apply

3.1.1.

"the Directive" means Council Directive 75/324/

EEC on the approximation of the laws of the

Member States relating to aerosol dispensers, as

amended by Commission Directive 94/01/EEC;

3.1.2.

"aerosol dispenser" means any non-reusable

container made of metal, glass or plastic and

containing a gas compressed, liquefied or

dissolved under pressure, with or without a liquid,

*see also regulation 1(3), (4), (5) and (6) of Legal Notice 395 of 2013 for the

applicability of the amendments made by the said legal notice as regards aerosol

dispensers containing a substance, aerosol dispensers containing mixtures and the

labelling of aerosol containers containing mixtures.

AEROSOL DISPENSERS

paste or powder, and fitted with a release device

allowing the contents to be ejected as solid or

liquid particles in suspension in a gas, as a foam,

paste or powder or in a liquid state;

3.1.3.

"OJ" means the Official Journal of the European

Communities;

3.1.4.

"manufacturer" means the person who is primarily

responsible for the design and construction of the

aerosol dispenser so that it complies with the

requirements of these regulations;

3.1.5.

"local authorised representative" means any

person (or organisation) established in Malta who

has been appointed by the manufacturer to act on

his behalf in carrying out certain tasks required by

these regulations;

3.1.6.

"importer" means any person who places aerosol

dispensers from a foreign country on to the

Maltese market so that he supplies such aerosol

dispensers on the first occasion that they are

supplied in Malta;

3.1.7.

"person who supplies aerosol dispensers" means

wholesalers, distributors, retailers, etc;

3.1.8.

"supply" includes offering to supply, agreeing to

supply, exposing for supply and possessing for

supply, and cognate expressions shall be construed

accordingly;

3.1.9.

"responsible person"

in

relation

to

aerosol

dispensers means

3.1.9.1.

the manufacturer thereof;

3.1.9.2.

the manufacturer’s local authorised

representative; or

3.1.9.3.

where the manufacturer is not

established in Malta and he has not

appointed

a

local

authorised

representative, the person who places

the aerosol dispensers on the local

market.

3.1.10.

"placing on the market" means importation

wholesale, retail, sale and distribution free of

charge.

1. The provisions of these regulations are applicable to all

imported aerosol dispensers as well as to those manufactured for

the local market.

4.1.1.

No person may construct, import, place on the

market or put into service any aerosol dispensers

which do not comply with the provisions of these

regulations.

AEROSOL DISPENSERS

1. The responsible person shall affix the symbol ‘3’ (inverted

epsilon) to aerosol dispensers, as proof that they satisfy the

requirements of these regulations and the Schedule.

5.2. Without prejudice to Regulation (EC) No 1272/2008 of the

European Parliament and of the Council, each aerosol dispenser or,

where particulars cannot be put on the aerosol dispenser due to its

small dimensions (maximum capacity of 150 ml or less) a label

attached thereto must bear the following particulars in visible, legible

and indelible characters

5.2.1.

the name and address or trade mark of the person

responsible for marketing the aerosol dispenser,

5.2.2.

the symbol ‘3’ (inverted epsilon) certifying

conformity with the requirements of these

regulations,

5.2.3.

code and markings enabling the filling batch to be

identified,

5.2.4.

the details referred to in point 2.2 of the Schedule,

5.2.5.

the net contents by weight and by volume,

5.2.6.

Where an aerosol dispenser contains flammable

components as defined in point 1.8 of the

Schedule but the aerosol dispenser is not

considered as "flammable" or "extremely

flammable" according to the criteria set out in

point 1.9 of the Schedule, the quantity of

flammable material contained in the aerosol

dispenser must be stated clearly on the label, in

the form of the following legible and indelible

wording: "X % by mass of the contents are

flammable".

5.3. The wording on the label of aerosol dispensers being

placed on the local market should be made in either the Maltese or

the English language.

5.4. All necessary measures shall be taken to prevent the use on

aerosol dispensers of markings or inscriptions which might be

confused with the symbol ‘3’ (inverted epsilon).

1. The marketing of any aerosol dispenser which complies

with the requirements of these regulations may not, for reasons

related to the requirements laid down in these regulations and the

Annex of the Directive, which is set out in the Schedule, be

refused, prohibited or restricted.

1. All appropriate measures shall be taken to encourage the

local authorities responsible for implementing these regulations to

cooperate with each other and provide each other with information

in order to assist the functioning of these regulations.

7.2. If the Director General of Technical Regulations Division

notes, on the basis of a substantive justification, that one or more

aerosol dispensers, although complying with the requirements of

these regulations, represent a hazard to safety or health, it may

provisionally prohibit the sale of the dispenser or dispensers in

AEROSOL DISPENSERS

Malta or subject it or them to special conditions.

7.2.1.

Such a decision shall be notified as soon as

possible to the party concerned, who shall at the

same time be informed of the legal remedies

available to him under the laws in force in Malta

and of the time limits to which such remedies are

subject.

7.2.2.

Deleted by Legal Notice 93 of 2017.

7.3. The Technical Regulations Division of the Malta Competition

and Consumer Affairs Authority shall immediately inform the

Commission and the other Member States of any measures taken in

pursuance of regulation 7.2.