Conformity assessment procedure for pyrotechnic articles

Conformity Assessment of Pyrotechnic Articles

Pyrotechnic articles are potentially hazardous products that must be assessed by an independent body to determine whether they meet the specified requirements before being placed on the market. Compliance with obligations regarding the handling of pyrotechnic products is monitored by the Czech Trade Inspection Authority, the Czech Mining Authority, the District Mining Authority, and the Czech Office for the Testing of Weapons and Ammunition. Previously, legislation regarding pyrotechnic products was quite confusing; pyrotechnic products were excluded from Act No. 22/1997 Coll. and also from Act No. 156/2000 Coll., on the verification of firearms, ammunition, and pyrotechnic articles and on the handling of certain pyrotechnic products, as amended (the Weapons Verification Act). A new Pyrotechnics Act was enacted, which implements, among other things, the principles of the new legislative framework, the REACH Regulation, and Directive 2013/29/EU (uncorrected version of February 10, 2018) on the placing of pyrotechnic articles on the market. Pyrotechnic products are governed by a separate Act No. 206/2015 Coll., on Pyrotechnic Products (Pyrotechnics Act), and Government Regulation No. 208/2015 Coll., on Technical Requirements for Pyrotechnic Products and Their Placing on the Market. The Pyrotechnics Act establishes a clear system for pyrotechnic articles and comprehensively regulates pyrotechnic articles, particularly in the areas of categories of pyrotechnic articles, obligations of economic operators, rules for the verification and marking of pyrotechnic products, conditions for affixing the CE marking, the storage and handling of pyrotechnic products, the professional competence of persons handling pyrotechnic products, and traceability. The traceability system for pyrotechnic products is established by Commission Implementing Directive No. 2014/58/EU.

SCOPE OF THE PYROTECHNICS ACT AND CATEGORIES OF PYROTECHNIC
PRODUCTS Act No. 206/2015 Coll. applies only to certain pyrotechnic products, their storage and handling, and to manufacturers, importers, and distributors of pyrotechnic products, as well as persons with professional qualifications for handling these products. The basic definition of types and categories of pyrotechnic products is set forth in Annex No. 1 of the Pyrotechnics Act. Pyrotechnic articles are classified according to their hazard level, intended use, and noise level.

AGE LIMITS AND OTHER
RESTRICTIONS Section 5 of the Pyrotechnics Act establishes age limits and other restrictions on access to and use of pyrotechnic articles, given the hazards associated with their use.

ESSENTIAL SAFETY
REQUIREMENTSThe essential safety requirements for pyrotechnic articles are set forth in Annex 2 of the Pyrotechnics Act.

PRESUMPTION OF CONFORMITY OF PYROTECHNIC
ARTICLESThe presumption of conformity of pyrotechnic articles with the essential safety requirements set forth in Annex 2 of the Pyrotechnics Act is based on their compliance with harmonized standards or parts thereof, references to which have been published in the Official Journal of the European Union.CONFORMITY

ASSESSMENT
PROCEDURES (Section 7 of the Pyrotechnics Act)

The Pyrotechnics Act specifies three conformity assessment procedures:

• EU type examination (requires the addition of a type conformity assessment procedure)
• conformity based on the conformity assessment of each individual product
• conformity based on comprehensive quality assurance for category F4 fireworks.

The type conformity assessment procedure is carried out through:

• internal production control and product testing under supervision at random intervals
• quality assurance of the production process
• quality assurance of the product

The manufacturer of a pyrotechnic product is required to submit the product to a notified body for conformity assessment prior to placing the pyrotechnic product on the market. The description and content of the individual conformity assessment procedures, including the documentation to be retained for each conformity assessment procedure, and the procedures to be followed by the manufacturer and the notified body for each conformity assessment procedure are set forth in Government Regulation No. 208/2015 Coll., on technical requirements for pyrotechnic articles and their placing on the market, in Annex No. 1. The manufacturer must attach to the application for conformity assessment the documentation specified for certain conformity assessment procedures in Section 3 of Government Regulation No. 208/2015 Coll.

Note: OS - Notified Body

If the notified body assesses the conformity of a pyrotechnic article with the essential safety requirements, it shall issue the manufacturer with:

• an EU type-examination certificate(MODULE B)
• a
• certificate of conformity (MODULE G)
• a quality system approval certificate (MODULE H for category F4)
• a certificate of conformity assessment (MODULE D or MODULE E)

EU TYPE-TESTING
CERTIFICATE (Section 6 of Government Regulation No. 208/2015 Coll.)
The EU type examination certificate and its annexes must enable an assessment of whether the pyrotechnic articles conform to the type that has undergone the EU type examination and the manufacturer’s verification checks of the specified requirements. The EU type examination certificate shall contain:

• the business name and registered office address or the first name, last name, and residential address of the manufacturer;
• the conclusions of the examination;
• the conditions for the validity of the certificate; and
• the data necessary to identify the approved type.

The EU type examination certificate may include an annex concerning modifications to the approved type of pyrotechnic article that may affect its conformity with the essential safety requirements of the Pyrotechnics Act.

CERTIFICATE OF CONFORMITY
(Section 7 of Government Regulation No. 208/2015 Coll.)

The content of the certificate of conformity includes:

• information guaranteeing the conformity of the pyrotechnic article with the type that was the subject of the EU type examination,
• the business name and registered office address or the name, last name, and residential address of the manufacturer
• ; the business name and registered office address or the name, last name, and residential address of the importer in the case of importation of a pyrotechnic product
• ; identification of the approved quality system;
• identification of the certificate holder
• ; identification of the notified body that issued the certificate;
• conclusions of
• the conformity assessment;
• and the period of validity of the certificate of conformity

MARKING OF PYROTECHNIC ARTICLES AND
TRACEABILITY For the purposes of traceability of pyrotechnic articles, the manufacturer marks its product with a registration number assigned to it by the notified body performing the conformity assessment. The registration number of a pyrotechnic article has the following structure:
XXXX – YY – ZZZZ, where

XXXX is the four-digit identification number of the notified body that issued the certificate;

YY is the category of the pyrotechnic article in abbreviated format:

• F1, F2, F3, or F4 – recreational pyrotechnics;
• T1 or T2 – theatrical pyrotechnics

;

• P1 or P2 – pyrotechnic products of other categories

; ZZZZ – the serial number of the pyrotechnic product assigned by the notified body to the pyrotechnic product.

The manufacturer or importer of pyrotechnic products must keep records of all registration numbers of the pyrotechnic products they manufacture or import, including the product name, type, sub-type of the product, and place of manufacture, for at least 10 years after the product is placed on the market. In the event of a change, these records must then be transferred to the successor legal entity; or, in the event of the manufacturer’s dissolution or death, if the heir or legal successor does not continue the business, they must be transferred to the notified body.

CEMARKING
The CEmarking is affixed directly to the pyrotechnic article by the manufacturer, always prior to placing the product on the market. In specific cases (where the size, shape, or nature of the pyrotechnic article does not allow the CE marking to be affixed directly to it), the CE marking must be affixed to its packaging and accompanying documentation. The CE marking is followed by the identification number of the notified body, if it was involved in the production control phase; this identification number of the notified body is affixed by the notified body or, in accordance with the notified body’s instructions, by the manufacturer.

MANUFACTURER’S OBLIGATIONS

• : Before placing a pyrotechnic article on the market, the manufacturer is required to submit the article to a notified body for conformity assessment; the requirements for the application are set forth in Section 8 of the Pyrotechnics Act
• . The manufacturer must attach documentation pertaining to the individual conformity assessment procedures to the application for conformity assessment; The scope and description of this documentation for the individual conformity assessment procedures are established by the Government in Government Regulation No. 208/2015 Coll.
• The manufacturer may place on the market only pyrotechnic articles for which conformity has been assessed.
• The manufacturer must ensure that the design and manufacture of the product comply with the essential technical requirements set out in Annex No. 2 of the
  Pyrotechnics Act. They must prepare the technical documentation specified for individual conformity assessment procedures in Annex No. 1 to Government Regulation No. 206/2015 Coll. and ensure that the relevant conformity assessment procedure is carried out.
• After demonstrating compliance with the essential requirements through the conformity assessment procedure, the manufacturer must draw up an EU Declaration of Conformity and affix the CE marking
• must retain the technical documentation for a period of 10 years from the date the pyrotechnic article is placed on the market
  must ensure that the manufacturing process and its controls conform to the type specified in the certificate and to the requirements of the Pyrotechnics Act
• must use an approved quality system for production, final inspection, design, and testing, and
• must
• inform the notified body of any changes.
• The manufacturer must use procedures in serial production that ensure compliance with the Pyrotechnics Act.
• The manufacturer must conduct testing and verification of pyrotechnic articles placed on the market to protect the health and safety of consumers.
• The manufacturer must keep distributors informed of these tests on an ongoing basis.
• The manufacturer must maintain records of complaints from users of pyrotechnic articles and of non-compliant pyrotechnic articles and pyrotechnic products withdrawn from circulation
• for end users and supervisory authorities must clearly indicate its identification details on the pyrotechnic product, its packaging, or in a document accompanying the product (the address must be the sole point of contact for the manufacturer)
• must ensure that clear instructions for use are provided with the pyrotechnic article
• must ensure that clear, distinctive, and indelible additional marking of the pyrotechnic article
• must take immediate necessary measures if it considers that a pyrotechnic article it has placed on the market does not comply with the Pyrotechnics Act (withdrawal of the product from the market or from circulation)
• must, in the event of non-compliance, immediately inform the competent authorities of the Member States of the Union in which the pyrotechnic article was placed on the market, providing details, in particular
• ,
• of the non-compliance with the requirements set forth in the Pyrotechnics Act
• must cooperate with the notified body in the performance of surveillance and in any measures to eliminate the risk posed by the pyrotechnic article, who placed

• the pyrotechnic product

• on the market
• must submit to the supervisory authority

• ,

• upon its written or electronic request

• ,

• all information in an intelligible form and the documentation necessary to demonstrate conformity

OBLIGATIONS OF THE IMPORTER

• may place on the market only pyrotechnic products for which conformity has been assessed
• the import of pyrotechnic products is subject to an import license (unless otherwise provided by Act No. 228/2005 Coll.)
• must ensure, prior to placing a pyrotechnic article on the market, that the manufacturer has carried out the relevant conformity assessment procedure in accordance with Section 7 of the Pyrotechnics Act
• ; after demonstrating the pyrotechnic article’s compliance with the requirements, the conformity assessment procedures must ensure that the manufacturer issues an EU Declaration of Conformity and that the pyrotechnic article bears the CE marking and is accompanied by the required documentation
• must ensure that the manufacturer uses procedures in serial production that ensure compliance with the Pyrotechnics Act
• must ensure that the manufacturer indicates their identification details on the pyrotechnic article (the address must be the sole location where the manufacturer can be contacted)
• must ensure that the manufacturer provides clear instructions for use of the pyrotechnic article and clear, legible, and indelible additional markings on the pyrotechnic article
• must take immediate necessary measures if it believes that the pyrotechnic article does not comply with the Pyrotechnics Act, must not place the pyrotechnic article on the market until the situation has been rectified
• if the pyrotechnic article poses a risk, must immediately inform the manufacturer and the competent supervisory authority
• must indicate its identification details on the pyrotechnic article, on its packaging, or in a document accompanying the product, and, where applicable, a trademark and contact address
• must ensure that instructions for use of the pyrotechnic article are provided in a comprehensible form
• must carry out testing and verification of pyrotechnic articles placed on the market for the purpose of protecting the health and safety of consumers
• must keep distributors informed of these tests on an ongoing basis
• must keep records of complaints from users of pyrotechnic articles and non-compliant pyrotechnic articlesand pyrotechnic products withdrawn from circulation
• must take immediate necessary measures if they believe that a pyrotechnic product they have placed on the market does not comply with the Pyrotechnics Act (withdrawal of the product from the market or from circulation)
• must, in the event of non-compliance, immediately inform the competent supervisory authority and provide details, in particular regarding non-compliance with the requirements set forth in the Pyrotechnics Act and the measures taken
• must retain a copy
• of
• the EU Declaration of Conformity for a period of 10 years from the date the pyrotechnic article was placed on the market
• must ensure the submission of the required documentation for individual conformity assessment procedures set forth in Government Regulation No. 208/2015 Coll. to the competent authorities upon request
• must submit to the supervisory authority, upon its written request or request in electronic form
• ,
• all information in a comprehensible form and the documentation necessary to demonstrate conformity
• must cooperate with the supervisory authorities in any measure taken to eliminate the risk posed by a pyrotechnic article placed on the market
• . If the importer places a pyrotechnic article on the market under its own name or trademark, or if it modifies a pyrotechnic article already placed on the market in a way that affects compliance with the requirements, the importer is considered a manufacturer and must fulfill the obligations of a manufacturer pursuant to Sections 18 and 19 of the Pyrotechnics Act.

OBLIGATIONS OF THE DISTRIBUTOR

• may only supply pyrotechnic articles to the market that have been assessed for conformity and whose shelf life has not expired
• must verify, prior to supplying the pyrotechnic article to the market, whether the product bears the CE marking, whether the required documentation is included
• must verify, prior to placing a pyrotechnic product on the market, whether the manufacturer or importer has ensured that the pyrotechnic product bears markings in accordance with the Pyrotechnics Act
• if they believe that a pyrotechnic product does not comply with the essential safety requirements in Annex 2 of the Pyrotechnics Act, it must not place the pyrotechnic article on the market until the non-compliance has been rectified
• if the pyrotechnic article poses a risk, it must immediately inform the manufacturer or importer and the competent supervisory authority
• must take the necessary immediate measures to withdraw it from the market or from circulation if it considers that the pyrotechnic article does not comply with the Pyrotechnics Act, immediately inform the supervisory authority thereof and provide details of the non-compliance and the corrective measures taken
• must submit to the supervisory authority, upon its written or electronic request, all information in an intelligible form and the documentation necessary to demonstrate the conformity of the pyrotechnic article with the technical requirements
• must cooperate with the supervisory authorities in measures taken with to eliminate the risk posed by a pyrotechnic article placed on the market
• ; if a distributor places a pyrotechnic article on the market under its own name or trademark, or if it modifies a pyrotechnic article already placed on the market in a way that affects compliance with the requirements, the distributor is considered a manufacturer and must fulfill the obligations of a manufacturer pursuant to Sections 18 and 19 of the Pyrotechnics Act.

ADDITIONAL OBLIGATIONS OF THE MANUFACTURER, IMPORTER, OR DISTRIBUTOR WHEN EXHIBITING AT TRADE FAIRS AND DEMONSTRATION EVENTS
A manufacturer, importer, or distributor may also display and use pyrotechnic articles that do not comply with the requirements of Act No. 206/2015 Coll., provided that they are clearly marked with the name and date of the trade fair, exhibition, or demonstration event and accompanied by information stating that the pyrotechnic products do not comply with Act No. 206/2015 Coll. and are not for sale. The manufacturer, importer, or distributor must ensure that safety measures are taken during the exhibition. Decree No. 284/2016 Coll., implementing certain provisions of the Pyrotechnics Act, contains safety measures for exhibitions.

TECHNICAL DOCUMENTATION  (TD)
Requirements for technical documentation are set forth in Section 4 of Government Regulation No. 206/2015 Coll. Minimum content of TD:

• a general description of the pyrotechnic product,
• conceptual design, manufacturing drawings and diagrams of components, subassemblies, circuits, and, where applicable, other parts of the product, including their descriptions and explanatory notes
• a list of harmonized standards that have been applied in full or in part and to which references have been published in the Official Journal of the European Union
• a description of the solutions adopted to meet the essential safety requirements of the Act
• a list of other technical specifications used, if harmonized standards were not applied
• the parts of harmonized standards that were used,
• results of design calculations,
• results of tests performed,
• other data necessary for assessing the conformity of the product,
• test reports

HANDLING OF PYROTECHNIC
PRODUCTS Chapter VI of the Pyrotechnics Act addresses the handling of pyrotechnic products:

• sale of pyrotechnic products § 24
• coding and destruction of pyrotechnic products § 25
• general requirements for the storage of pyrotechnic products § 26
• storage in sales premises and small storage facilities § 27
• storage in warehouses § 28
• storage and sale of Category F1 pyrotechnic products § 29
• research, development, and testing§ 30
• Display of pyrotechnic products § 31
• Fireworks § 32
• Fireworks displays § 33
• Permits for fireworks displays § 34
• Records of pyrotechnic products used in fireworks displays § 35

PROFESSIONAL
QUALIFICATION Chapter IX of the Pyrotechnics Act concerns professional qualification:

• professional competence § 36
• certificate of professional competence § 37
• professional training for obtaining a certificate of professional competence § 38
• medical fitness for the purposes of issuing a certificate of professional competence § 39
• revocationof certificates of professional competence § 40
• list of persons with professional competence and issued and revoked certificates of professional
  competence § 41

NOTIFIED BODY
Chapter X of the Pyrotechnics Act is devoted to provisions concerning notified bodies:

• Notification of bodies § 42
• Requirements for notified bodies § 43
• Presumption of conformity of notified bodies § 44
• Subsidiaries and subcontractors of notified bodies § 45
• Application for notification § 46
• Notification procedure § 47
• Changes to notifications § 48
• Obligations regarding the activities of notified bodies § 49
• Revocationand amendment of the validity of an issued certificate § 50