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Royal Decree 473/2014, 13 June, Amending The Royal Decree 1381 / 2009, 28 August, Which Lays Down The Requirements For The Manufacture And Marketing Of Aerosol Generators.

Original Language Title: Real Decreto 473/2014, de 13 de junio, por el que se modifica el Real Decreto 1381/2009, de 28 de agosto, por el que se establecen los requisitos para la fabricación y comercialización de los generadores de aerosoles.

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TEXT

Royal Decree 1381/2009 of 28 August 2009 laying down requirements for the manufacture and placing on the market of aerosol dispensers incorporates in a single regulatory text the provisions relating to the aerosol dispensers, including the provisions of Council Directive 75 /324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers, as amended for the purposes of Directive 75 /324/EEC, their adaptation to technical progress by Directives 94 /1/EC and 2008 /47/EC.

In Council Directive 75 /324/EEC of 20 May 1975 a classification of aerosols as "non-flammable", "flammable" or "extremely flammable" is collected according to the classification criteria laid down in the Annex. When an aerosol generator is classified as 'flammable' or 'extremely flammable', it must bear the symbol of the flame and the safety phrases S2 and S16 laid down in 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.

By Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on the classification, labelling and packaging of substances and mixtures and amending and repealing Directives 67 /548/EEC and 1999 /45/EC and Regulation (EC) No 1907/2006 is amended to harmonise the classification and labelling of substances and mixtures in the Union. This Regulation incorporates into the Union the criteria for classification and labelling of substances and mixtures of the Globally Harmonised System of Classification and Labelling of Chemicals, which has been adopted at international level in the framework of the of the United Nations.

The Commission Directive 2013 /10/EU of 19 March 2013 amending Directive 75 /324/EEC on the approximation of the laws of the Member States relating to the protection of the health and safety at work has been adopted. aerosol dispensers, in order to adapt their 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.

In drawing up this royal decree, which incorporates into Spanish law the Commission Directive 2013 /10/EU, the provisions of Article 5 of Royal Decree 1801/2008 of 3 November 2008 have been taken into account by the Commission. laying down rules on the nominal quantities for packaged products and on the control of their actual content.

As provided for in Article 62 of Regulation (EC) No 1272/2008 of the Parliament and of the Council of 16 December 2008, the provisions of Title II, Title III and Title IV thereof shall apply to mixtures as from 1 June 2015. Taking this into account and in order to avoid unnecessary burdens on businesses, the royal decree contains a transitional provision on the enforceability of the new requirements, on voluntary labelling before that date and finally on the new labelling of aerosol dispensers placed on the market before 1 June 2015 containing mixtures and labelled in accordance with the provisions applicable before that date.

During the processing of this royal decree, the hearing procedure provided for in Article 24.1.c of Law 50/1997, of 27 November, of the Government, has been carried out, the autonomous communities and the entities representing the sectors concerned and the required report of the Industrial Safety Coordination Council as laid down in Article 18.4.c of Law 21/1992 of 16 July 1992 on Industry.

This provision is made under the terms of Article 149.1. 13. of the Spanish Constitution, which attributes to the State the competence to determine the bases and coordination of the general planning of economic activity, and of the provisions of Article 149.1.10. of the Constitution, which it attributes to the State exclusive competence in the field of external trade, without prejudice to the powers of the autonomous communities in the field of industry.

In its virtue, on the proposal of the Ministry of Industry, Energy and Tourism, in agreement with the State Council, and after deliberation by the Council of Ministers at its meeting on 13 June 2014,

DISPONGO:

Single item. Amendment of Royal Decree 1381/2009 of 28 August 2009 laying down the requirements for the manufacture and placing on the market of aerosol dispensers.

Royal Decree 1381/2009 of 28 August 2009 laying down the requirements for the manufacture and placing on the market of aerosol dispensers is amended as follows:

One. Article 6 (1) is amended as follows:

" 1. Without prejudice to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 October 2008 on the classification, labelling and packaging of substances and mixtures and amending and repealing the Directives 67 /548/EEC and 1999 /45/EC and amended Regulation (EC) No 1907/2006, the aerosol dispensers or the label attached thereto, where the reduced size of the package does not allow any indication to be given (packages with equal capacity or less than 150 millilitres), the following particulars must be visible, legible and indelible:

(a) The name and address or trademark of the person responsible for the marketing of the aerosol generator.

b) The symbol according to the present royal decree, that is, the sign "3" (inverted epsilon).

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

(d) The data referred to in paragraph B. 2 of the Annex.

e) The volume content. "

Two. In paragraph (A) of the Annex, paragraphs 7a and 7b are added with the following wording:

" 7 bis. Substance. 'Substance' means a chemical element and its natural compounds or those obtained by an industrial process, including the additives necessary to preserve its stability and the impurities which it inevitably produces. the procedure, excluding all solvents which can be separated without affecting the stability of the substance or modifying its composition (as defined in Article 2). 7 of Regulation (EC) No 1272/2008 of the Parliament and of the Council of 16 December 2008).

7 ter. Mixture.-"mixture" means a mixture or solution composed of two or more substances (as defined in Article 2.8 of Regulation (EC) No 1272/2008 of the Parliament and of the Council of 16 December 2008). '

Three. Paragraph (B) of the Annex is amended as follows:

" B) General provisions.

Without prejudice to specific provisions of the Annex relating to the requirements for the danger of flammability and pressure, the person responsible for the marketing of aerosol dispensers shall be required to analyse the hazards to identify those that are applicable to their products. Where appropriate, this analysis shall include an examination of the risks resulting from the inhalation of the spray emitted by the aerosol generator under normal or reasonably foreseeable conditions of use, taking into account the size distribution of the drops in combination with the physical and chemical properties of the contents. It shall then design, manufacture and test it and, where appropriate, draw up special declarations concerning its use, taking into account the analysis it has made.

1. Manufacturing and equipment.

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

(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 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, aerosol dispensers must bear the following particulars in a visible, legible and indelible form:

a) Whatever its content:

1. The code for the hazard indication H229: " Pressure pack. It can burst if heated ",

2. The precautionary advice P210 and P251 referred to in Part 1, Table 6.2 of Annex IV to Regulation (EC) No 1272/2008 of the Parliament and of the Council of 16 December 2008.

3. The precautionary advice P410 and P412 referred to in Part 1, Table 6.4 of Annex IV to Regulation (EC) No 1272/2008 of the Parliament and of the Council of 16 December 2008.

4. The precautionary advice P102 referred to in Part 1, Table 6.1 of Annex IV to Regulation (EC) No 1272/2008 of the Parliament and of the Council of 16 December 2008 when the aerosol generator is a consumer product, and

5. Any additional use caution that warns consumers of the specific hazards of the product; if the aerosol generator carries separate handling instructions, they must also include such instructions. precautions for use.

b) If the aerosol is classified as "non-flammable" according to the criteria in paragraph A. 9 of the Annex, the word "attention" warning.

(c) If the aerosol is classified as "flammable" in accordance with the criteria of paragraph A. 9 of the Annex, the word "attention" and the other indications to be shown on the labels of the "Aerosols" flammable category 2 " as referred to in Table 2.3.2 of Annex I to Regulation (EC) No 1272/2008 of the Parliament and of the Council of 16 December 2008.

d) If the aerosol is classified as "extremely flammable" in accordance with the criteria of paragraph A. 9 of the Annex, the word "danger" and the other indications which must appear on the labels of the 'Flammable aerosols of category 1' referred to in Table 2.3.2 of Annex I to Regulation (EC) No 1272/2008 of the Parliament and of the Council of 16 December 2008.

3. Volume of the liquid phase. -A 50 ° C, the volume of the liquid phase of the aerosol generator must not exceed 90% of the net capacity. '

Single transient arrangement. Time limits for the requirement of new requirements and conditions in the case of aerosol dispensers containing mixtures.

1. In the case of aerosol dispensers containing mixtures, the new requirements and conditions which are established, by means of the modifications introduced in Royal Decree 1381/2009, of 28 August, by this royal decree, will be from 1 June 2015 onwards.

2. By way of derogation from paragraph 1, aerosol generators containing mixtures may be labelled voluntarily in accordance with the new requirements and conditions before 1 June 2015.

3. Aerosol dispensers containing mixtures and having been placed on the market before 1 June 2015 shall not be re-labelled in accordance with the new requirements and conditions until 1 June 2017.

Final disposition first. Competence title.

This provision is dictated by the provisions of Article 149.1.13. of the Spanish Constitution, which attributes to the State the competence to determine the bases and coordination of the general planning of the activity. Article 149.1.10. of the Constitution, which confers exclusive competence on the State in matters of foreign trade, without prejudice to the powers of the Autonomous Communities in matters of industry.

Final disposition second. Incorporation of European Union law.

This royal decree incorporates into Spanish law the Commission Directive 2013 /10/EU of 19 March 2013 amending Directive 75 /324/EEC on the approximation of the laws of the Member States members on aerosol dispensers, in order to adapt their 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.

Final disposition third. Entry into force.

This royal decree will enter into force on the day following its publication in the "Official State Gazette".

Given in Madrid, June 13, 2014.

JOHN CARLOS R.

The Minister of Industry, Energy and Tourism,

JOSE MANUEL SORIA LOPEZ