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Harmonisation of the Laws of the Member States Relating to the Making Available Market of Pyrotechnic Articles Text with EEA Relevance Directive
Article 1: Subject matter
Article 2: Scope
Article 3: Definitions
Article 4: Free movement
Article 5: Making available on the market
Article 6: Categories of pyrotechnic articles
Categorisation shall be as follows:
Article 7: Age limits and other limitations
Article 8: Obligations of the manufacturers
Where compliance of a pyrotechnic article with the applicable requirements has been demonstrated by that procedure, manufacturers shall draw up an EU declaration of conformity and affix the CE marking.
When deemed appropriate with regard to the risks presented by a pyrotechnic article, manufacturers shall, to protect the health and safety of consumers, upon a duly justified request of the competent authorities, carry out sample testing of pyrotechnic articles made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming pyrotechnic articles and pyrotechnic article recalls, and shall keep distributors informed of any such monitoring.
Article 9: Traceability
Article 10: Labelling of pyrotechnic articles other than pyrotechnic articles for vehicles
Article 11: Labelling of pyrotechnic articles for vehicles
The safety data sheet may be supplied on paper or electronically, provided that the professional user has the necessary means of accessing it.
Article 12: Obligations of importers
Where an importer considers or has reason to believe that a pyrotechnic article is not in conformity with the essential safety requirements set out in Annex I, he shall not place the pyrotechnic article on the market until it has been brought into conformity. Furthermore, where the pyrotechnic article presents a risk, the importer shall inform the manufacturer and the market surveillance authorities to that effect.
Article 13: Obligations of distributors
Where a distributor considers or has reason to believe that a pyrotechnic article is not in conformity with the essential safety requirements set out in Annex I, he shall not make the pyrotechnic article available on the market until it has been brought into conformity. Furthermore, where the pyrotechnic article presents a risk, the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance authorities.
Article 14: Cases in which obligations of manufacturers apply to importers and distributors
Article 15: Identification of economic operators
Article 16: Presumption of conformity of pyrotechnic articles
Article 17: Conformity assessment procedures
Article 18: EU declaration of conformity
Article 19: General principles of the CE marking
Article 20: Rules and conditions for affixing the CE marking and other markings
The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer.
Article 21: Notification
Article 22: Notifying authorities
Article 23: Requirements relating to notifying authorities
Article 24: Information obligation on notifying authorities
The Commission shall make that information publicly available.
Article 25: Requirements relating to notified bodies
A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of pyrotechnic articles and/or explosive substances, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.
Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.
At all times and for each conformity assessment procedure and each kind or category of pyrotechnic articles in relation to which it has been notified, a conformity assessment body shall have at its disposal the necessary:
The remuneration of the top level management and personnel responsible for carrying out the conformity assessment tasks of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments.
Article 26: Presumption of conformity of notified bodies
Article 27: Subsidiaries of and subcontracting by notified bodies
Article 28: Application for notification
Article 29: Notification procedure
Only such a body shall be considered a notified body for the purposes of this Directive.
Article 30: Identification numbers and lists of notified bodies
It shall assign a single such number even where the body is notified under several Union acts.
The Commission shall ensure that the list is kept up to date.
Article 31: Changes to notifications
Article 32: Challenge of the competence of notified bodies
That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 44(2).
Article 33: Operational obligations of notified bodies
In so doing they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the pyrotechnic article with the requirements of this Directive.
Article 34: Appeal against decisions of notified bodies
Article 35: Information obligation on notified bodies
Article 36: Exchange of experience
Article 37: Coordination of notified bodies
Member States shall ensure that the bodies notified by them participate in the work of that forum, directly or by means of designated representatives.
Article 38: Union market surveillance and control of pyrotechnic articles entering the Union market
Article 39: Procedure for dealing with pyrotechnic articles presenting a risk at national level
Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance authorities find that the pyrotechnic article does not comply with the requirements laid down in this Directive, they shall without delay require the relevant economic operator to take all appropriate corrective actions to bring the pyrotechnic article into compliance with those requirements, to withdraw the pyrotechnic article from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as they may prescribe.
The market surveillance authorities shall inform the relevant notified body accordingly.
Article 21 of Regulation 2008/765 shall apply to the measures referred to in the second subparagraph of this paragraph.
The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures.
Article 40: Union safeguard procedure
The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators.
Article 41: Compliant pyrotechnic articles which present a risk to health or safety
The implementing acts referred to in the first subparagraph shall be adopted in accordance with the examination procedure referred to in Article 44(3).
On duly justified imperative grounds of urgency relating to the protection of health and safety of persons, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 44(4).
Article 42: Formal non-compliance
Article 43: Implementing acts
Article 44: Committee procedure
The committee may furthermore examine any other matter concerning the application of this Directive raised either by its chair or by a representative of a Member State in accordance with its rules of procedure.
Article 45: Penalties
The penalties provided for shall be effective, proportionate and dissuasive.
Article 46: Transitional provisions
Article 47: Transposition
They shall apply those measures from 1 July 2015.
Article 48: Repeal
By way of derogation from the first paragraph of this Article, point 4 of Annex I to Directive 2007/23/EC is repealed with effect from 4 July 2013.
References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex V.
Article 49: Entry into force and application
Article 1, Article 2, points 1 to 6, 8 to 11 and 14 of Article 3, Article 4(2), (3) and (4), Article 6, Article 7(1), (2) and (3), Article 8(1), Article 10(1), (3) and (4), Article 11(2), Articles 17, 30 and 36, Article 38(3), Articles 43 and 44 and Annexes IV and V shall apply from 1 July 2015.
Article 50: Addressees
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ESSENTIAL SAFETY REQUIREMENTS ESSENTIAL SAFETY REQUIREMENTS
Each pyrotechnic article must attain the performance characteristics specified by the manufacturer to the notified body in order to ensure maximum safety and reliability.
Each pyrotechnic article must be designed and manufactured in such a way that it can be disposed of safely by a suitable process with minimum effect on the environment.
Each pyrotechnic article must function correctly when used for its intended purpose.
Each pyrotechnic article must be tested under realistic conditions. If this is not possible in a laboratory, the tests must be carried out in the conditions in which the pyrotechnic article is to be used.
The following information and properties — where applicable — must be considered or tested:
Pyrotechnic articles must not contain detonative explosives other than black powder and flash composition, except for pyrotechnic articles of categories P1, P2, T2 and fireworks of category F4 meeting the following conditions:
A. Fireworks Fireworks
CONFORMITY ASSESSMENT PROCEDURES CONFORMITY ASSESSMENT PROCEDURES
MODULE B: EU-type examination EU-type examination
Conformity to type based on internal production control plus supervised product checks at random intervals is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the pyrotechnic articles concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them.
Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured pyrotechnic articles with the type described in the EU-type examination certificate and with the requirements of this Directive that apply to them.
Product checks
A notified body, chosen by the manufacturer, shall carry out product checks or have them carried out at random intervals determined by the body, in order to verify the quality of the internal checks on the pyrotechnic article, taking into account, inter alia, the technological complexity of the pyrotechnic articles and the quantity of production. An adequate sample of the final products, taken on site by the notified body before the placing on the market, shall be examined and appropriate tests as identified by the relevant parts of the harmonised standards and/or equivalent tests set out in other relevant technical specifications, shall be carried out to check the conformity of the pyrotechnic article with the type described in the EU-type examination certificate and with the relevant requirements of this Directive. Where a sample does not conform to the acceptable quality level, the body shall take appropriate measures.
The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the pyrotechnic article performs within acceptable limits, with a view to ensuring conformity of the pyrotechnic article.
The manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process.
CE marking and EU declaration of conformity
Conformity to type based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the pyrotechnic articles concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them.
Manufacturing
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the pyrotechnic articles concerned as specified in point 3 and shall be subject to surveillance as specified in point 4.
Quality system
Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued.
MODULE E: Conformity to type based on product quality assurance Conformity to type based on product quality assurance
Conformity to type based on product quality assurance is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the pyrotechnic articles concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them.
Manufacturing
The manufacturer shall operate an approved quality system for final product inspection and testing of the pyrotechnic articles concerned as specified in point 3 and shall be subject to surveillance as specified in point 4.
Quality system
Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued.
MODULE G: Conformity based on unit verification Conformity based on unit verification
Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 5, and ensures and declares on his sole responsibility that the pyrotechnic article concerned, which has been subject to the provisions of point 4, is in conformity with the requirements of this Directive that apply to it.
Technical documentation
The manufacturer shall establish the technical documentation and make it available to the notified body referred to in point 4. The documentation shall make it possible to assess the pyrotechnic article’s conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the pyrotechnic article. The technical documentation shall, wherever applicable, contain at least the following elements:
Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured pyrotechnic article with the applicable requirements of this Directive.
Verification
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests, set out in the relevant harmonised standards and/or equivalent tests set out in other relevant technical specifications, to check the conformity of the pyrotechnic article with the applicable requirements of this Directive, or have them carried out. In the absence of such a harmonised standard the notified body concerned shall decide on the appropriate tests to be carried out.
The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to the approved pyrotechnic article, or have it affixed under its responsibility.
The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the pyrotechnic article has been placed on the market.
CE marking and EU declaration of conformity
Conformity based on full quality assurance is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the pyrotechnic articles concerned satisfy the requirements of this Directive that apply to them.
Manufacturing
The manufacturer shall operate an approved quality system for design, manufacture and final product inspection and testing of the pyrotechnic articles concerned as specified in point 3 and shall be subject to surveillance as specified in point 4.
Quality system
Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued.
EU DECLARATION OF CONFORMITY (No XXXX) ( 1 ) EU DECLARATION OF CONFORMITY (No XXXX)
PART A
Repealed Directive with the amendment thereto Repealed Directive with the amendment thereto
(referred to in Article 48) (referred to in Article 48)
Time-limits for transposition into national law and dates of application Time-limits for transposition into national law and dates of application
(referred to in Article 48) (referred to in Article 48)
CORRELATION TABLE CORRELATION TABLE
Footnote p0: Done at Strasbourg, 12 June 2013.