Conformity Assessment of Aerosol Dispensers
Aerosol dispensers
"Aerosol dispensers" are single-use containers made of metal, glass, or plastic that contain gas compressed, liquefied, or dissolved under pressure together with a liquid, paste, or powder, or without them, and are fitted with a closure allowing the discharge of the contents in the form of solid or liquid particles suspended in gas, in the form of foam, paste, or powder, or in a liquid state. The definition of aerosols is also provided in Regulation (EC) No. 1272/2008 (CLP Regulation).
Aerosol dispensers have a very wide range of uses, such as:
- cosmetic products (deodorants, antiperspirants, hairsprays, hair glosses, mousse, dry shampoos, shaving foams, sunscreen and after-sun sprays...),
- medical devices and medicinal products (disinfectants, topical anesthetics, inhalers, ...),
- veterinary products (insecticides and repellents),
- technical products,
- household products (air fresheners, paints, car care products, cleaning agents, ...),
- food products (whipped cream, oils).
Government Regulation No. 194/2001 Coll. does not apply to aerosol dispensers where the container has a volume:
a) less than 50 ml,
b) greater than 1000 ml for metal containers,
c) greater than 220 ml for containers made of plastic-coated glass or permanently protected glass containers and plastic containers that cannot produce shards upon rupture,
d) greater than 150 ml for unprotected glass containers and plastic containers that can produce shards upon rupture.
Essential RequirementsThe essential requirements for aerosol dispensers under normal conditions of use and storage are set forth in Annex No. 1 to Government Regulation No. 194/2001 Coll. Annex No. 1 is divided into four parts:
- general requirements (design, equipment of the aerosol dispenser, requirements for the closure, labeling on the aerosol dispenser, ...),
- specific requirements for aerosol dispensers with metal containers,
- specific requirements for aerosol dispensers with glass containers,
- specific requirements for aerosol dispensers with plastic containers.
market (pursuant to Section 12(3) of Act No. 22/1997 Coll.), the manufacturer or importer must perform a conformity assessment. The procedures set forth in Annex No. 2 to Government Regulation No. 194/2001 Coll. shall be followed.
Annex No. 2 lists the tests to be performed by the person placing the aerosol dispenser on the market, such as tests on empty containers, on filled containers, flammability tests of aerosols, or the method for evaluating test results (requirements for the test report). Some tests and requirements are listed below. Overpressure
Testing of Empty Containers
The person responsible for placing the aerosol dispenser on the market shall ensure that the burst pressure of the containers is at least 20% higher than the specified test overpressure. The test overpressure shall be determined by a hydraulic test of empty containers made of metal, plastic, or glass in accordance with Annex No. 1 to Government Regulation No. 194/2001 Coll.
For coated glass containers, a free-fall test shall be performed.
The gas pressure contained in the aerosol dispenser at 50 °C must not exceed:
- 1.2 MPa for flammable liquefied gas
- 1.32 MPa for non-flammable liquefied gas
- 1.5 MPa for non-flammable compressed gas or dissolved gas under pressure
Liquid phase volumeThe
liquid phase volume at 50 °C must not exceed 90% of the container’s usable volume.
Flammability
: If an aerosol dispenser contains flammable components (i.e., liquids, flammable gases, or flammable solids) with a flash point ≤ 93°C, then the aerosol is flammable. Tests for the flammability of aerosols are described in Annex No. 2 to Government Regulation No. 194/2001 Coll. The flammability criteria for aerosol dispensers and labeling requirements for aerosol dispensers are set forth in Annex No. 1 to Government Regulation No. 194/2001 Coll.
The final inspection of filled aerosol dispensers is described in Annex 2 of Government Regulation No. 194/2001 Coll.
Technical Documentation
Annex 2 also sets out the requirements for the technical documentation that the person responsible for placing the product on the market must submit to the competent authority with the application for approval. The documentation must be drawn up in an official language of the EC or a certified copy must be available. Flammability
: If an aerosol dispenser contains flammable components (i.e., liquids, flammable gases, or flammable solids) with a flash point ≤ 93°C, then the aerosol is flammable. The flammability criteria for aerosol dispensers and the labeling requirements for aerosol dispensers are set forth in Annex No. 1 of Government Regulation No. 194/2001 Coll. Flammability tests for aerosols are described in Annex No. 2 of Government Regulation No. 194/2001 Coll.
: A person placing aerosol dispensers on the market is required to label them with the symbol "3" (inverted epsilon) (in accordance with the directive on aerosol dispensers), which serves as proof that they comply with the requirements of the directive and its annex.
The graphic design is not prescribed; the FEA recommends a symbol size of at least 3 mm.
3 In
addition to the symbol "3" (inverted epsilon) , the following information must be clearly and indelibly indicated:
- first name, last name, place of business (natural person), business name and registered office (legal entity),
- markings enabling identification of the fill quantity (date of manufacture, batch number),
- and, if the aerosol is classified as "non-flammable," the signal word “Warning” and other labeling elements for “Category 3 aerosols” according to the CLP Regulation
- ; if the aerosol is classified as “flammable,” the signal word “Warning” and other labeling elements for “Category 2 aerosols” according to the CLP Regulation
- ; if the aerosol is classified as “extremely flammable,” the signal word “Danger” and other label elements for “Category 1 aerosols” under the CLP Regulation
- if the aerosol dispenser is a consumer product, the safety instruction P102 (“Keep out of reach of children.”)
- all instructions for use of the aerosol dispenser that alert consumers to specific hazards associated
with the product; - the instructions may be provided as a separate product use manual
- the contents of the refill expressed by the weight or volume of the liquid phase
Exemption for labeling small aerosol containers : small aerosol dispensers with a maximum volume of 150 ml or less. This information may be provided on a label attached to the aerosol dispenser.
Additional information: Depending
on the internal design
- ,
- single-chamber with liquefied gas, containing a charge predominantly in the liquid state; the propellant is usually halogenated hydrocarbons; the pressure in the containers is constant; the advantage is complete consumption of the contents, the disadvantage is flammability
- ; single-chamber with compressed gas contain the contents in a liquid state, with an insoluble gas (air, nitrogen) or a soluble gas (carbon dioxide) above the contents, the advantage is non-flammability; the disadvantage is that when the pressure drops, the remaining contents stay in the container
- two-chamber (bag-on-valve, bag-on-can) contain the filling in a barrier package; compressed propellant gas is located between the filling package and the container wall; they are used for shower gels, shaving foams, and creams; the advantage is that nearly all of the filling is used up; the disadvantage is the cost
Czech Aerosol Association (ČAS)
www.cz-aerosol.czEvropská Aerosol Federation (FEA - Federation of European Aerosols)
www.aerosol.orgvýrobci Aerosol Containers
BALL AEROSOL PACKAGING CZ s.r.o. -
www.ball.comMORAVIA CANS, a.s. -
www.moraviacans.czvýrobce aerosol valves and atomizers
KOH-I-NOOR Mladá Vožice a.s. -
www.kohinoor.czplniči aerosol products
CZECH AEROSOL, a.s. -
www.czechaerosol.czAEROSOL-SERVICE a.s. -
www.aerosol.czAVEFLOR, a. s. -
www.aveflor.czFILSON s.r.o -
www.filson.czdalší:
ASTRID T.M., a. s. -
www.astrid.czHF SERVIS s.r.o. –
www.hfmarket.czMOTIP DUPLI s.r.o. – www.motipdupli.cz
