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Royal Decree 2549 / 1994, Of 29 December, Which Modifies The Complementary Technical Instruction Wed-Ap3 Of Regulation Of Pressure, Aerosol Generators Concerning Devices.

Original Language Title: Real Decreto 2549/1994, de 29 de diciembre, por el que se modifica la instrucción técnica complementaria MIE-AP3 del Reglamento de aparatos a presión, referente a generadores de aerosoles.

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TEXT

Article 12.5 of the current Law 21/1992, of July 16, of Industry, determines that the State-wide Industrial Security Regulations will be approved by the Government of the Nation.

By Royal Decree 472/1988 of 30 March 1988, the detailed rules for the implementation of Council Directive 75 /324/EEC on the approximation of the Member States relating to aerosol dispensers (Official Journal of the European Communities) were adopted. European Communities-Special edition in Spanish 1985chapter 13, volume 04).

The Commission of the European Communities has adopted Directive 94 /11/EEC of 6 January on the technical adaptation of Directive 75 /324/EEC (Official Journal of the European Communities No L 23, 28). January 1994).

When the supplementary technical instruction MIE-AP3 was approved, on aerosol dispensers, by order of 25 January 1982, the content of the Regulation was already included in the Regulation of pressure equipment, although it did not Council Directive 75 /324/EEC. Subsequent amendments, by orders of 25 March 1985 and 5 June 1987, brought the text of the JTI closer to the provisions of the Community Directive in such a way that, in practice, it is in line with the requirements of Royal Decree 472/1988.

Consequently, it is considered appropriate, by regulatory economy, to provide for a single regulatory text the provisions relating to aerosol dispensers, including the provisions of Directive 75 /324/EEC, is amended by Directive 94 /1/EC in complementary technical instruction MIE-AP3. At the same time, given the optional nature of the abovementioned Community Directives, it is necessary, in accordance with Articles 30 and following of the EC Treaty, to admit in the Spanish market not only aerosol dispensers which are in conformity with the provisions of the these Directives, but also those which are manufactured and checked in accordance with the technical regulations of the Member States, provided that they guarantee at least the same level of protection as that offered by the ITC.

In its virtue, on the proposal of the Minister of Industry and Energy, in agreement with the Council of State, after deliberation of the Council of Ministers at its meeting of the day of December 29, 1994,

DISPONGO:

Article 1.

The supplementary technical instruction MIE-AP3 of the Regulation of pressure equipment, concerning aerosol dispensers, whose new wording appears as an annex to this Royal Decree, is amended.

Article 2.

The manufacturers of aerosol dispensers are exempt from the obligation to carry the book registration mentioned in the article ninth of the Regulation of pressure equipment.

Article 3.

aerosol dispensers are exempt from compliance with Article 19 (plates and apparatus identification) of the same Regulation.

Single additional disposition.

However, in the case of the JTI MIE-AP3 annexed, aerosol dispensers from other EC Member States and the European Economic Area which comply with their regulations will be admitted to the Spanish market. national, provided that they are a level of safety equivalent to that provided by the requirements of that ITC.

Single transient arrangement.

aerosol dispensers manufactured prior to the date of entry into force of the JTI annex may be placed on the market until 1 April 1997, provided that they comply with the rules existing at that date.

Single repeal provision.

Royal Decree No 472/1988 of 30 March 1988 laying down detailed rules for the application of Council Directive 75 /324/EEC on aerosol dispensers and the supplementary technical instruction MIE-AP3 of the Regulation of pressure equipment for aerosol dispensers, approved by Order of 25 January 1982 and subsequently amended by Order of 28 March 1985 and Order of 5 June 1987.

Single end disposition.

The provisions of this Royal Decree shall apply from 1 April 1995.

Given in Madrid on December 29, 1994.

JOHN CARLOS R.

The Minister of Industry and Energy,

JUAN MANUEL EGUIAGARAY UCELAY

" ANNEX

MIE-AP3 Complementary Technical Instruction

1. This ITC shall apply to aerosol dispensers as defined in paragraph 2 of this Technical Instruction, except for those whose containers have a total capacity of less than 50 millilitres, and those whose container has a total capacity exceeding the total capacity referred to in paragraphs (C) .1, D) .1.1. (D) .2.1. (D) (1) and (E) .2 of the Appendix to this ITC.

2. For the purposes of this JTI, an aerosol generator means the assembly consisting of a non-reusable metal, glass or plastic container containing a liquefied or dissolved compressed gas at pressure with or without liquid, paste or powder, and this The invention relates to a device for discharging the content in the form of solid or liquid particles suspended in a gas, in the form of foam, paste or powder, or in liquid state.

3. The person responsible for placing the aerosol dispensers on the market shall affix the sign "3" (inverted epsilon) to the latter by means of which it shall be certified that the aerosols comply with the requirements of this ITC and the appendix.

4. It shall not be possible, for reasons relating to the requirements referred to in this ITC and its appendix, to refuse, prohibit or restrict the placing on the market of aerosol dispensers which comply with the requirements of this ITC and its appendix.

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

(a) The name and address or registered trademark of the person responsible for placing the aerosol generator on the market.

b) The symbol in accordance with this ITC, i.e. the sign "3" (inverted epsilon).

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

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

e) Net content by volume.

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

6. Aerosol dispensers with marks and inscriptions which may be confused with the sign "3" (inverted epsilon) may not be placed on the market.

7. Where the person responsible for placing the aerosol dispensers on the market has supporting evidence based on appropriate tests or analyses to demonstrate that these aerosol dispensers, despite the fact that they contain flammable components, do not are at risk of inflammation under normal or reasonably foreseeable conditions of use, may be low

their own responsibility, not to apply the provisions laid down in paragraphs B) .2.b) and B) .3.b) of the Appendix.

You will have a copy of these documents available to the competent authority of the Administration.

In this case, the quantity of flammable components contained in the aerosol dispenser must be visible, legible and indelible on the label as follows: ' Contains X per 100 in mass of components flammable ".

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

APPENDIX

A) Definitions.

1. Pressures.

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

2. Test pressure.

"Test pressure" means the pressure at which the empty container of the aerosol generator may be subjected for 25 seconds without any escaping and without the metal or plastic containers having to be visible and permanent deformations, with the exception of those permitted under paragraph F) .1.a)

.

3. Burst pressure.

A "break pressure" means the minimum pressure that produces an opening or a break of the aerosol generator container.

4. Total capacity of the container.

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

5. Net capacity.

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

6. Volume of the liquid phase.

"Liquid phase volume" means the volume occupied by the non-gaseous phases in the aerosol generator container.

7. Test conditions.

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

8. Flammable components.

Flammable components "means substances and preparations which meet the criteria laid down for the" extremely flammable "," easily flammable "and" flammable " categories set out in Annex VI of the Directive 67 /548/EEC.

The flammable properties of the components contained in the container shall be determined in accordance with the specific methods described in Part A of Annex V to the abovementioned Directive.

B) General provisions.

1. Manufacture and equipment.

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

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

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

2. Labelling.

Without prejudice to the provisions of the Directives on the classification, packaging and labelling of dangerous substances and preparations, in particular as regards the danger to health and the environment, Aerosol generator shall bear the following particulars in a visible, legible and indelible manner:

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

(b) Where it contains flammable components as defined in paragraph A) .8: in accordance with the provisions of Annex II to Directive 67 /548/EEC, the symbol, where appropriate, and the indication of the danger of inflammation which present the substances and/or preparations contained in the aerosol generator, including the propellant, as well as the corresponding risk phrases assigned according to the criteria set out in paragraphs 2.2.3, 2.2.4 or 2.2.5 of Annex VI of the Directive mentioned above.

3. Specific indications for use.

Without prejudice to the provisions of the Directives on the classification, packaging and labelling of dangerous substances and preparations, in particular as regards the danger to health or the environment, Aerosol generator shall bear the following particulars in a visible, legible and indelible manner:

(a) Whatever their content: the complementary precautions for employment that inform consumers of the specific hazards of the product.

b) When containing flammable components, caution warnings:

1. º "Do not vaporize toward an incandescent flame or body."

2. º "Stay away from any ignition source-No smoking".

3. "Stay out of reach of children".

C) Special provisions for aerosol dispensers with a metal container.

1. Capacity.

The total capacity of these vessels may not exceed 1,000 millilitres.

1. Test Pressure of the Canister.

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

(b) For containers to be conditioned at a pressure equal to or greater than 6,7 bar at 50 ° C, the test pressure must be greater than 50 per 100 at the internal pressure at 50 ° C.

2. Conditioning.

At 50 ° C, the pressure of the aerosol generator must not exceed 12 bars, whichever type of gas is used for the conditioning.

3. Volume of the liquid phase.

At 50 ° C, the volume of the existing liquid phase must not exceed 87 per 100 of the net capacity.

2. However, in respect of the concave bottom containers which are convexed in a convex manner before bursting, the volume of the liquid phase, at 50 ° C, may reach 95 per 100 of the net capacity.

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

1. Permanently protected or plasticized containers.

Containers of this type may be used for conditioning with compressed, liquid, or dissolved gas.

1.

The total capacity of these vessels may not exceed 220 millilitres.

2. Coating.

The coating must be made up of a protective wrap of plastic material or of any other suitable material, in order to avoid the risk of glass fragments being projected in case of accidental rupture of the container, and must be manufactured in such a way that glass fragments are not projected when the aerosol generator, subjected to the temperature of 20 ° C, falls from a height of 1,8 metres above a concrete floor.

3. Th Canister Test Pressure.

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

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

4. Conditioning.

(a) Aerosol dispensers fitted with compressed gases must not have to resist, at 50 ° C, a pressure of more than 9 bar.

(b) Aerosol dispensers fitted with dissolved gases must not have to resist, at 50ºC, a pressure of more than 8 bar.

(c) Aerosol generators fitted with liquefied gases or mixtures of liquefied gases must not have to resist, at 20 ° C, pressures higher than those indicated in the following table:

Total Capacity/Percentage by Weight of Liquefied Gas in Total Mix: 20 per 100/50 per 100/80 per 100

50 to 80 ml.

/3.5 bar.

/2.8 bar.

/2.5 bar.

Between 80 ml. and 160 ml.

/3.2 bar.

/2.5 bar.

/2.2 bar.

Between 160 ml. and 220 ml.

/2.8 bar.

/2.1 bar.

/1.8 bar.

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

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

5. Volume of the liquid phase.

At 50 ° C, the volume of the liquid phase of the aerosol generator must not exceed 90 per 100 of the net capacity.

2. Glass container not protected.

Aerosol generators using non-protected glass containers shall be exclusively conditioned by liquefied or dissolved gas.

1.

The total capacity of these vessels may not exceed 150 millilitres.

2. The Test Pressure of the Canister.

This pressure must be at least 12 bar.

3. Conditioning.

(a) Aerosol dispensers fitted with dissolved gases must not have to resist, at 50 ° C, a pressure of more than 8 bar.

(b) Aerosol dispensers fitted with liquefied gases must not have to resist, at 20 ° C, pressures higher than those indicated in the following table:

Total Capacity/Percentage by Weight of Liquefied Gas in Total Mix: 20 per 100/50 per 100/80 per 100

Between 50 and 70 millilitres

/1.5 bars

/1.5 bars

/1.25 bars

Between 70 and 150 millilitres

/1.5 bars

/1.5 bars

/1 bar

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

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

4. Volume of the liquid phase.

At 50 ° C, the volume of the liquid phase of the air conditioning generator with liquefied or dissolved gas shall not exceed 90 per 100 of the net capacity.

E) Special provisions for aerosol dispensers with a plastic container.

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

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

F) Tests.

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

a) Hydraulic testing with empty containers.

1. The metal, glass or plastic containers of aerosol dispensers must be able to withstand a hydraulic pressure test in accordance with points C) .1.1., D) .1.3. and D) .2.2.

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

b) Proof of breaking of empty metal containers.

The person responsible for placing the product on the market must ensure that the pressure of the vessel's breakage exceeds at least 20 per 100 to the intended test pressure.

c) Test of falling of the protected glass containers. The manufacturer shall ensure that the containers comply with the test conditions referred to in paragraph (D) .1.2

d) Individual testing of the conditioned aerosol generators.

1. (a) Each aerosol generator must be immersed in a water bath.

The temperature of the water and the duration of the dip in the bath must allow: that the contents of the aerosol generator reach the uniform temperature of 50 ° C or that the pressure of the aerosol generator reaches the temperature of the contents at a uniform temperature of 50 ° C.

(b) Aerosol dispensers with visible and permanent deformations or escapes shall be discarded.

2. However, the person responsible for placing the product on the market, under his responsibility and with the consent of the Committee referred to in Article 6 of Directive 75 /324/EEC, may use any test system which permits obtain a result equivalent to the water bath system.

2. Examples of control tests to be carried out.

a) Test with empty containers.

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

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

b) Test of conditioned aerosol generators.

Hermetic control tests shall be performed by immersion in a water bath of a significant number of such generators. The temperature of the water and the duration of the dip in the bath must allow the contents to reach the uniform temperature of 50 ° for the time necessary to ensure that no escapes or breakages are produced. Aerosol dispensers which do not satisfy these tests shall be considered unusable. '