# COMMISSION DIRECTIVE 2008/47/EC
of 8 April 2008
amending, for the purposes of adapting to technical progress, Council Directive 75/324/EEC on the approximation of the laws of the Member States relating to aerosol dispensers
(Text with EEA relevance)
## Preamble
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers [^1] , and in particular Articles 5 and 10(3) thereof,
Whereas:
**(1)** Technical progress and innovation have made possible the placing on the market of an increasing number of aerosol dispensers with a complex technical design and characteristics different from the traditional ones. However, the provisions of Directive 75/324/EEC are not sufficient to guarantee a high level of safety for such non-traditional aerosol dispensers. The individual design of non-traditional aerosols may create safety hazards that are not addressed by the safety provisions of the Directive, which are adapted to the known design of traditional aerosols. Therefore, a hazard analysis is necessary to be performed by the manufacturer in order to cover all safety aspects adequately.
**(2)** Where appropriate the hazard analysis must address the risk resulting from the inhalation of the spray ejected by the aerosol dispenser under normal or reasonably foreseeable conditions of use, taking into account droplet size and size distribution in conjunction with physical and chemical properties of the contents, as the inhalation of small aerosol droplets may give rise to adverse health effects for the user under such conditions of use, even if the aerosol dispenser is properly classified and labelled according to the provisions of Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations [^2] .
**(3)** The safeguard clause provided for in Article 10 of Directive 75/324/EEC has been applied by one Member State. The safeguard measure adopted is justified in view of the risk of flammability raised, under normal or reasonably foreseeable conditions of use, by the substances contained in the aerosol dispenser.
**(4)** The current definition of flammable contents is not sufficient to guarantee a high level of safety in all cases. In particular, although some contents dispersed by aerosol dispensers are not defined as ‘flammable’ according to the criteria listed in Annex VI to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances [^3] , they may lead to ignition under normal or reasonably foreseeable conditions of use of the aerosol dispenser. Furthermore, the current criteria for flammability only address chemical substances and preparations and do not take properly into account special physical conditions of an aerosol spray or specific conditions of use.
**(5)** In order to achieve the optimal level of safety and considering the specificities of aerosol dispensers, the new criteria for the classification of the flammability of aerosol dispensers should also address the hazards relating to the dispersion of the contents of aerosol dispensers and the specific conditions of use of the aerosol dispensers rather than only the physical and chemical properties of the contents themselves.
**(6)** The provisions of Directive 75/324/EEC currently in force require that each filled aerosol dispenser be immersed in a bath of hot water in order to assess its leak tightness and burst resistance. However, heat sensitive aerosol dispensers cannot withstand this test. Technological progress has made possible alternative test methods for the final assessment of aerosol dispensers for burst resistance and leak tightness, which guarantee the same level of safety.
**(7)** The provisions of Directive 75/324/EEC currently in force provide for the possibility to use a test system enabling a result equivalent to that of the water bath method, subject to the agreement of the Committee referred to in Article 6. However, this procedure appears to be extremely heavy to be implemented in practice, and therefore, it has never been used. Therefore, in order to enable economic operators to benefit from technological progress without compromising the current level of safety by guaranteeing the appropriate technical expertise, it is necessary that the alternative test methods are approved, instead of the Committee referred to in Article 6 of the Directive, by the relevant competent authorities designated by Member States under Council Directive 94/55/EC of 21 November 1994 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by road [^4] .
**(8)** Safety concerns have been raised following the burst and leak of metal aerosol dispensers heated to high temperatures, as is the case in cars exposed to solar radiation. It is therefore necessary to limit the maximum filling level to the same value for all types of aerosol dispensers.
**(9)** Most environmentally friendly and non-flammable propellants are compressed gases. However, the loss of pressure of aerosol dispensers using compressed gas propellants at the end of their life-time typically leads to a less efficient yield of contents. Consequently, the use of compressed gases as propellants should be encouraged by increasing the maximum internal pressure of aerosol dispensers, to the extent that it is safe for the consumer.
**(10)** Directive 75/324/EEC should therefore be amended accordingly.
**(11)** The measures provided for in this Directive are in accordance with the opinion of the Committee on the adaptation to Technical Progress of the Directive on aerosol dispensers,
HAS ADOPTED THIS DIRECTIVE:
## **Article 1**
Directive 75/324/EEC is amended as set out in the Annex to this Directive.
## **Article 2**
**1.** Member States shall adopt and publish by 29 October 2009 the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. Member States shall apply those provisions as from 29 April 2010. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such a reference is to be made.
**2.** Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.
## **Article 3**
This Directive shall enter into force on the 20th day following its publication in the *Official Journal of the European Union* .
## **Article 4**
This Directive is addressed to the Member States.
## Final provisions
Done at Brussels, 8 April 2008. *For the Commission* Günter VERHEUGEN *Vice-President*
[^1] [OJ L 147, 9.6.1975, p. 40](http://publications.europa.eu/resource/oj/JOL_1975_147_R_TOC) . Directive as last amended by Regulation (EC) No 807/2003 ( [OJ L 122, 16.5.2003, p. 36](http://publications.europa.eu/resource/oj/JOL_2003_122_R_TOC) ).
[^2] [OJ L 200, 30.7.1999, p. 1](http://publications.europa.eu/resource/oj/JOL_1999_200_R_TOC) . Directive as last amended by Regulation (EC) No 1907/2006 ( [OJ L 396, 30.12.2006, p. 1](http://publications.europa.eu/resource/oj/JOL_2006_396_R_TOC) ; corrected by [OJ L 136, 29.5.2007, p. 3](http://publications.europa.eu/resource/oj/JOL_2007_136_R_TOC) ).
[^3] [OJ 196, 16.8.1967, p. 1](http://publications.europa.eu/resource/oj/JOP_1967_196_R_TOC) . Directive as last amended by Directive 2006/121/EC of the European Parliament and of the Council ( [OJ L 396, 30.12.2006, p. 850](http://publications.europa.eu/resource/oj/JOL_2006_396_R_TOC) , corrected by [OJ L 136, 29.5.2007, p. 281](http://publications.europa.eu/resource/oj/JOL_2007_136_R_TOC) ).
[^4] [OJ L 319, 12.12.1994, p. 7](http://publications.europa.eu/resource/oj/JOL_1994_319_R_TOC) . Directive as last amended by Commission Directive 2006/89/EC ( [OJ L 305, 4.11.2006, p. 4](http://publications.europa.eu/resource/oj/JOL_2006_305_R_TOC) ).
Directive 75/324/EEC is hereby amended as follows:
**(1)** in Article 8 the following paragraph 1a is added:
‘1a. Where an aerosol dispenser contains flammable components as defined in point 1.8 of the Annex but the aerosol dispenser is not considered as “flammable” or “extremely flammable” according to the criteria set out in point 1.9 of the Annex, 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”.’;
**(2)** Article 9a is repealed;
**(3)** the Annex is amended as follows:
| (a) | (a): flammable liquid means a liquid having a flashpoint of not more than 93 °C. | (a) | flammable liquid means a liquid having a flashpoint of not more than 93 °C. | (b) | 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 burning match, and if the flame spreads rapidly. | (c) | 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. |
| --- | --- | --- | --- | --- | --- | --- | --- |
| (a) | flammable liquid means a liquid having a flashpoint of not more than 93 °C. | | | | | | |
| (b) | 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 burning match, and if the flame spreads rapidly. | | | | | | |
| (c) | 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. | | | | | | |
| (b) | (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; | (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. | (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. | (a) | (i): The aerosol is classified as “flammable” if ignition occurs at a distance equal or greater than 15 cm but less than 75 cm; | (i) | The aerosol is classified as “flammable” if ignition occurs at a distance equal or greater than 15 cm but less than 75 cm; | (ii) | The aerosol is classified as “extremely flammable” if ignition occurs at a distance of 75 cm or more; | (iii) | 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/m 3 or the deflagration density is less than or equal to 300 g/m 3 ; otherwise the aerosol is classified as “non-flammable”; | (b) | 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”. | (a) | (i): the flame height is 20 cm or more and the flame duration is two seconds or more; or | (i) | the flame height is 20 cm or more and the flame duration is two seconds or more;
or | (ii) | the flame height is 4 cm or more and the flame duration is seven seconds or more. | (b) | 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.’; |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| (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. | | | | | | | | | | | | | | | | | | | | | | | | |
| (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. | | | | | | | | | | | | | | | | | | | | | | | | |
| (a) | (i): The aerosol is classified as “flammable” if ignition occurs at a distance equal or greater than 15 cm but less than 75 cm; | (i) | The aerosol is classified as “flammable” if ignition occurs at a distance equal or greater than 15 cm but less than 75 cm; | (ii) | The aerosol is classified as “extremely flammable” if ignition occurs at a distance of 75 cm or more; | (iii) | 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/m 3 or the deflagration density is less than or equal to 300 g/m 3 ; otherwise the aerosol is classified as “non-flammable”; | | | | | | | | | | | | | | | | | | |
| (i) | The aerosol is classified as “flammable” if ignition occurs at a distance equal or greater than 15 cm but less than 75 cm; | | | | | | | | | | | | | | | | | | | | | | | | |
| (ii) | The aerosol is classified as “extremely flammable” if ignition occurs at a distance of 75 cm or more; | | | | | | | | | | | | | | | | | | | | | | | | |
| (iii) | 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/m 3 or the deflagration density is less than or equal to 300 g/m 3 ; otherwise the aerosol is classified as “non-flammable”; | | | | | | | | | | | | | | | | | | | | | | | | |
| (b) | 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”. | | | | | | | | | | | | | | | | | | | | | | | | |
| (a) | (i): the flame height is 20 cm or more and the flame duration is two seconds or more; or | (i) | the flame height is 20 cm or more and the flame duration is two seconds or more;
or | (ii) | the flame height is 4 cm or more and the flame duration is seven seconds or more. | | | | | | | | | | | | | | | | | | | | |
| (i) | the flame height is 20 cm or more and the flame duration is two seconds or more;
or | | | | | | | | | | | | | | | | | | | | | | | | |
| (ii) | the flame height is 4 cm or more and the flame duration is seven seconds or more. | | | | | | | | | | | | | | | | | | | | | | | | |
| (b) | 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.’; | | | | | | | | | | | | | | | | | | | | | | | | |
| (c) | (a): 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 | (a) | 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 | (b) | applying the following calculation method: | ΔH c | = | chemical heat of combustion (kJ/g) of the product; | w i % | = | mass fraction of component i in the product; | ΔH c(i) | = | specific heat of combustion (kJ/g) of component i in the product. |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| (a) | 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 | | | | | | | | | | | | | |
| (b) | applying the following calculation method: | | | | | | | | | | | | | |
| ΔH c | = | chemical heat of combustion (kJ/g) of the product; | | | | | | | | | | | | |
| w i % | = | mass fraction of component i in the product; | | | | | | | | | | | | |
| ΔH c(i) | = | specific heat of combustion (kJ/g) of component i in the product. | | | | | | | | | | | | |
(d) The following provision is inserted after point 2. ‘General provisions’ and before point 2.1. ‘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.’
| (e) | ‘(b): Where the aerosol is classified as “flammable” or “extremely flammable” according to the criteria of point 1.9: — the flame symbol, in accordance with the model in Annex II to Directive 67/548/EEC; — the indication “flammable” or “extremely flammable”, depending on the classification of the aerosol as “flammable” or “extremely flammable”.’; — — — the flame symbol, in accordance with the model in Annex II to Directive 67/548/EEC; — — — the indication “flammable” or “extremely flammable”, depending on the classification of the aerosol as “flammable” or “extremely flammable”.’;
—: the flame symbol, in accordance with the model in Annex II to Directive 67/548/EEC;
—: the indication “flammable” or “extremely flammable”, depending on the classification of the aerosol as “flammable” or “extremely flammable”.’; | ‘(b) | —: the flame symbol, in accordance with the model in Annex II to Directive 67/548/EEC; | — | the flame symbol, in accordance with the model in Annex II to Directive 67/548/EEC; | — | the indication “flammable” or “extremely flammable”, depending on the classification of the aerosol as “flammable” or “extremely flammable”.’; |
| --- | --- | --- | --- | --- | --- | --- | --- |
| ‘(b) | —: the flame symbol, in accordance with the model in Annex II to Directive 67/548/EEC; | — | the flame symbol, in accordance with the model in Annex II to Directive 67/548/EEC; | — | the indication “flammable” or “extremely flammable”, depending on the classification of the aerosol as “flammable” or “extremely flammable”.’; | | |
| — | the flame symbol, in accordance with the model in Annex II to Directive 67/548/EEC; | | | | | | |
| — | the indication “flammable” or “extremely flammable”, depending on the classification of the aerosol as “flammable” or “extremely flammable”.’; | | | | | | |
| (f) | ‘(a): Whatever its contents, 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; | ‘(a) | Whatever its contents, 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; | (b) | —: the safety phrases S2 and S16 laid down in Annex IV to Directive 67/548/EEC; | — | the safety phrases S2 and S16 laid down in Annex IV to Directive 67/548/EEC; | — | “Do not spray on a naked flame or any incandescent material”.’; |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| ‘(a) | Whatever its contents, 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; | | | | | | | | |
| (b) | —: the safety phrases S2 and S16 laid down in Annex IV to Directive 67/548/EEC; | — | the safety phrases S2 and S16 laid down in Annex IV to Directive 67/548/EEC; | — | “Do not spray on a naked flame or any incandescent material”.’; | | | | |
| — | the safety phrases S2 and S16 laid down in Annex IV to Directive 67/548/EEC; | | | | | | | | |
| — | “Do not spray on a naked flame or any incandescent material”.’; | | | | | | | | |
(g) the following point 2.4. is inserted: ‘2.4. Volume of the liquid phase The volume of the liquid phase at 50 °C must not exceed 90 % of the net capacity.’
(h) Point 3.1.2. is replaced by the following: ‘3.1.2. Filling At 50 °C, the pressure in the aerosol dispenser must not exceed 12 bar. However, if the aerosol does not contain a gas or mixture of gases having a flammable range with air at 20 °C and a standard pressure of 1,013 bar, the maximum allowable pressure at 50 °C is 13,2 bar.’
(i) points 3.1.3., 4.1.5. and 4.2.4. are deleted.
| (j) | (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. | (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. | (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.’; |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| (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. | | | | | | | | | | | | | | |
| (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.’; | | | | | | | | | | | | | | |
| (k) | 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. |
| --- | --- |
[^1]: . Directive as last amended by Regulation (EC) No 807/2003 ().
[^2]: . Directive as last amended by Regulation (EC) No 1907/2006 (; corrected by ).
[^3]: . Directive as last amended by Directive 2006/121/EC of the European Parliament and of the Council (, corrected by ).
[^4]: . Directive as last amended by Commission Directive 2006/89/EC ().