Conformity assessment procedure for explosives for civil use

CONFORMITY ASSESSMENT – Explosives for Civil Use as of April 20, 2016

1. blasting agents,
2. detonators, safety fuses, and shock tubes,
3. detonators (including time-delay detonators), flash-bang delayers,
4. propellants and solid propellants.

Technical Requirements for
Explosives Annex No. 1 to Government Regulation No. 97/2016 Coll. contains general and specific requirements for explosives.
General requirements concern the design, manufacture, and delivery of explosives up to the time of their use, as well as the functional properties of explosives in terms of maximum safety and reliability, including requirements for their disposal with minimal environmental impact. Specific requirements apply to the characteristic properties of the explosive, its chemical composition—particularly the compatibility of all components with regard to physical and chemical stability—as well as requirements for chemical purity, degree of homogenization, particle size distribution, and dimensions. The explosive must also undergo testing for physical and chemical stability under the environmental conditions in which it may be used. Tests are also conducted on sensitivity to impact and friction, the explosive’s resistance to moisture, resistance to low and high temperatures, the explosive’s suitability for use in hazardous environments, and the resistance of the explosive and its packaging to decomposition during storage until the manufacturer’s specified expiration date. Safety features against premature or unintentional initiation or ignition of the explosive, as well as the correct loading and functioning of the explosive when used for its intended purpose, are verified. Appropriate instructions and labeling for the safe handling, storage, use, and disposal of the explosive are checked, including all equipment and accessories necessary for the reliable and safe operation of the explosive. All such tests must be conducted under realistic conditions. If the tests cannot be conducted under laboratory conditions, they must be conducted under the conditions of the intended use of the explosive.

Explosives Used for Own Use
: Obligations and compliance with essential technical requirements, including conformity assessment, are also required for explosives that do not enter the supply chain—i.e., explosives used by the manufacturer for its own use. The use of explosives for own use refers to the manufacturer’s use of explosives in blasting operations. A person who uses explosives for their own use is also considered a manufacturer.

Conformity
Assessment Procedures The manufacturer shall use one of the following procedures to assess the conformity of explosives with the essential technical requirements set out in Annex 1:

a) EU type examination (Module B) in accordance with Annex No. 2 of Government Regulation No. 97/2016 Coll., and simultaneously one of the following procedures:

1. Module C2 – conformity to type based on internal production control, together with product checks under supervision at random intervals
2. Module D – conformity to type based on quality assurance of the production process
3. Module E – conformity to type based on product quality assurance
4. Module F – conformity to type based on product verification

b) conformity based on the verification of each individual product (Module G) in accordance with Annex No. 2 to Government Regulation No. 97/2016 Coll.

Note: NB - Notified Body

Technical Documentation (TD)
Minimum content of the technical documentation: general description of the explosive; conceptual design, manufacturing drawings, and diagrams of components; descriptions and explanations to understand the drawings, diagrams, and operation of the explosive; a list of harmonized standards that have been applied in full or in part; if harmonized standards have not been applied—a description of the solution chosen to meet the essential technical requirements according to Annex No. 1 of Government Regulation No. 97/2016 Coll., including a list of other relevant technical specifications used; an indication of those parts of the harmonized standards that were used only partially; results of design calculations and tests performed; test reports. The technical documentation for the explosive must specify the essential technical requirements pursuant to Annex No. 1 to Government Regulation No. 97/2016 Coll. and enable an assessment of the explosive’s conformity with these requirements. An integral part of the technical documentation for the explosive must be an analysis and assessment of the risks associated with the explosive. To assess the conformity of the explosive with the essential technical requirements set forth in Annex 1 to Government Regulation No. 97/2016 Coll., the technical documentation must include a description of the design, manufacture, and operation of the explosive to the extent necessary. The manufacturer, or its authorized representative, shall keep the technical documentation, a copy of the EU type examination certificate, its annexes, and amendments for a period of at least 10 years from the date the explosive is placed on the market or used for its own purposes, even if conformity assessment is no longer carried out.

EU Declaration of
ConformityThe EU Declaration of Conformity is drawn up by the manufacturer prior to placing the explosive on the market in accordance with the model set out in detail in Annex No. 4 to Government Regulation No. 97/2016 Coll. If an explosive is subject to multiple European Union harmonization regulations requiring the preparation of an EU Declaration of Conformity, a single EU Declaration of Conformity is prepared with references to all such regulations, including references to their publication. The manufacturer, or its authorized representative (if the manufacturer has appointed one to perform certain tasks pursuant to Act No. 90/2016 Coll. and Government Regulation No. 97/2016 Coll.), shall retain the EU Declaration of Conformity for at least 10 years from the date the explosives are placed on the market or used for the manufacturer’s own purposes, even if conformity assessment is no longer ongoing. The importer shall keep a copy of the EU Declaration of Conformity for at least 10 years from the date the explosives are placed on the market.

CE
MarkingThe CEmarking is affixed directly to the explosive by the manufacturer or by their authorized representative, always prior to placing the product on the market. In specific cases (where the size, shape, or nature of the explosive does not allow the CE marking to be affixed directly to the explosive), it is sufficient to affix the CE marking simultaneously to its packaging and to the accompanying documentation. For explosives manufactured for use for own needs, for explosives transported and supplied without packaging, for explosives manufactured by a mobile unit preparing explosives at the point of use for direct loading into a borehole, or manufactured at the blasting site and loaded into a borehole immediately after manufacture, it is sufficient to affix the CE marking to the accompanying documentation.

Obligations of Economic
OperatorsThe obligations of the manufacturer, authorized representative, and importer are generally defined in Act No. 90/2016 Coll. on Conformity Assessment. Government Regulation No. 97/2016 Coll. contains provisions regarding the obligations of the distributor, with relevant references to the distributor’s obligations set forth in Act No. 90/2016 Coll.

Distributor
: Before placing an explosive on the market, the distributor is required to verify that the explosive bears the CE marking, as well as the product identification and information provided by the manufacturer or importer. Under Act No. 90/2016 Coll., the manufacturer is required to provide the following information on the explosive: product information and identification data, as well as identification and contact details regarding the manufacturer, as specified by government regulation. The manufacturer must ensure that clear and comprehensible instructions and safety information in the Czech language are provided with the product. The identification and contact information that the importer is required by Act No. 90/2016 Coll. to provide on the explosive in the Czech language are: the importer’s name, trade name, or registered trademark, and the importer’s address for service. If the size, shape, or design of the explosive does not allow for these details to be indicated directly on the explosive, they shall be indicated on its packaging or accompanying documentation. The scope of information and identification data for the explosive is specified in Section 10 of Government Regulation No. 97/2016 Coll. The information and identification data of the explosive and the accompanying documents serve as identification for traceability purposes.

Traceability of Explosives and Requirements for Marking Explosives for Traceability
Purposes Every explosive that poses a risk of misuse is subject to traceability. Annex No. 3 to Government Regulation No. 97/2016 Coll. lists, in its first part, exceptions that are not subject to this traceability requirement. Specific requirements for the marking of explosives for traceability purposes are also set forth in the second part of Annex No. 3 to Government Regulation No. 97/2016 Coll.

Annex No. 3 to Government Regulation No. 97/2016 Coll. also contains an example of a graphic representation for the purposes of explosive traceability when using a matrix or bar code.

Another applicable Czech legal regulation for the marking and traceability of explosives for civilian use is Act No. 83/2013 Coll., under which, pursuant to Section 3, the Czech Mining Authority assigns a three-digit numerical code to each explosives production site upon request by persons engaged in the explosives industry.

For traceability purposes, Annex No. 3 to Government Regulation No. 97/2016 Coll. uses an alphanumeric code in accordance with the requirements of the technical standard ČSN ISO 3166-1:2015 Codes for the names of countries and their subdivisions – Part 1: Country codes (97 1002) (en).

Pursuant to Section 12 of Government Regulation No. 97/2016 Coll., the supervisory authority may decide to prohibit the placing of a product on the market, its putting into service, or its use by the manufacturer for its own needs, or to withdraw the product from the market or from circulation if:

• the explosive has been unlawfully affixed with the CE marking in violation of Act No. 90/2016 Coll. or Government
  Regulation No. 97/2016 Coll.;
• the explosive has not been affixed with the CE marking;
• the identification number of the notified body was affixed to the CE marking in violation of Act No. 90/2016 Coll. or Government Regulation No. 97/2016 Coll.;
• the identification number of the notified body was not affixed to the CE marking at all;
• the EU declaration of conformity was drawn up in violation of Act No. 90/2016 Coll. or Government Regulation No. 97/2016 Coll.;
• the EU Declaration of Conformity was not drawn up at all;
• the technical documentation for the explosive is missing pursuant to Government Regulation No. 97/2016 Coll.;
• the technical documentation is incomplete;
• 
  the explosive is not provided with information and identification data and accompanying documents in accordance with Section 10 of Government Regulation No. 97/2016 Coll.;
• the explosive is not accompanied by instructions for its safe use;
• the document specifying the properties of the explosive pursuant to Section 10(3) of Government Regulation No. 97/2016 Coll. is missing