Government Regulation No. 97 / 2016 Coll.

Government Regulation on Technical Requirements for Explosives

Valid Regulation Effective from 20.04.2016
97
GOVERNMENT REGULATION
of 16 March 2016
on technical requirements for explosives
The Government hereby orders pursuant to Article 4 of Act No. 90 / 2016 Coll., on the conformity assessment of specified products when making them available on the market ("the Act '), to implement § 3 (d), § 4, § 5 (2), § 6 (2) and (3), § 7, § 8 (2) and (4), § 9 (2), § 12 (1), § 14 (2) and (3), § 15 (2), § 23 (1) (a) and § 50 (5) of the Act:
§ 1
Subject matter
(1) This Regulation implements the relevant provisions of the European Union1), and provides for
(a) technical requirements for explosives (2);
(b) the method of assessment of the conformity of explosives;
(c) the conditions and rules for drawing up the EU declaration of conformity and for placing the CE marking,
(d) procedures for making explosives available on the market;
(e) details of the activities of economic operators and notified bodies in conformity assessment.
(2) Explosives are products intended for conformity assessment under Section 4 of the Act.
(3) This Regulation shall not apply to explosives which are acquired from a manufacturer excluding a distributor or being held by:
(a) by the armed forces of the Czech Republic, the Military Police, the Security Corps of the Czech Republic, the Czech Office for the Testing of Weapons and Ammo and the Police Schools established by the Ministry of Interior; or
(b) by armed forces or security forces of other States when they are present on the territory of the Czech Republic, in transit through the territory of the Czech Republic or in transit over the territory of the Czech Republic, where this results from an international treaty which is part of the rule of law.
§ 2
Definition of terms
The manufacturer shall also be the person using the explosive for his own use; the use of the explosive for own use is the use of the explosive by the manufacturer in shredding works.
§ 3
Basic technical requirements
(1) The essential technical requirements which an explosive must meet before being placed on the market are set out in Annex 1 to this Regulation. The explosive shall meet the essential technical requirements as long as it is to be handled.
(2) Compliance with the essential technical requirements referred to in paragraph 1 shall be demonstrated by conformity assessment.
(3) For an explosive which complies with the essential technical requirements referred to in paragraph 1 and has been assessed for conformity, the manufacturer shall draw up an EU declaration of conformity and place the CE marking on the explosive.
§ 4
Explosives used for own use
The obligations laid down by law and by this Regulation shall apply also to the use of the explosive by the manufacturer for his own use before or in connection with the placing on the market of the explosive, or, where appropriate, his authorised representative. Where this Regulation provides for a period of retention of documentation from the placing on the market of an explosive, that period shall also apply from the time of use of the explosive for its own use.
§ 5
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 to this Regulation:
(a) the EU type-examination (Module B) referred to in Annex 2 to this Regulation and at the same time one of these procedures;
1. conformity with the type based on internal production control together with supervised product checks at random intervals (Module C2) referred to in Annex 2 to this Regulation,
2. conformity with the type based on the quality assurance of the production process (module D) referred to in Annex 2 to this Regulation;
3. conformity with the type based on product quality assurance (module E) in accordance with Annex 2 to this Regulation; or
4. conformity with the product verification type (Module F) referred to in Annex 2 to this Regulation; or
(b) conformity based on verification of each individual product (Module G) as set out in Annex 2 to this Regulation.
§ 6
Technical documentation
(1) The technical documentation for the explosive must:
(a) specify the essential technical requirements referred to in Annex 1 to this Regulation applicable to the explosive and allow the assessment of the compliance of the explosive with those requirements;
(b) include an analysis and assessment of the risks associated with the explosive; and
(c) include a description of the design, manufacture and operation of the explosive to the extent necessary to assess its compliance with the essential technical requirements set out in Annex 1 to this Regulation.
(2) The technical documentation shall contain at least:
(a) a general description of the explosive;
(b) conceptual design, manufacturing drawings and schemes of components,
(c) descriptions and explanations necessary for understanding these drawings, diagrams and the operation of the explosive;
(d) a list of harmonised standards which have been applied in full or in part and a description of the solutions chosen to meet the essential technical requirements set out in Annex 1 to this Regulation, provided that those harmonised standards have not been applied, including a list of other relevant technical specifications which have been used. In the case of partly applied harmonised standards, the technical documentation shall specify the parts which have been used,
(e) the results of the design calculations carried out, and
(f) test reports.
(3) The technical documentation, as well as other documents as set out in Annex 2 to this Regulation, must be kept by the manufacturer for the period laid down in this Annex, even if there is no conformity assessment. Where the manufacturer has appointed an authorised representative to carry out some of his tasks under the law and this Regulation, the retention period for such documentation and documents shall apply mutatis mutandis to the manufacturer.
§ 7
EU declaration of conformity
(1) The EU declaration of conformity shall be drawn up by the manufacturer before the explosive is placed on the market and shall contain the particulars set out in Annex 4 to this Regulation.
(2) Where explosives are also covered by other legislation governing the drawing up of an EU declaration of conformity, a single EU declaration of conformity shall be drawn up.
(3) The EU declaration of conformity shall be kept by the manufacturer for the period laid down in Annex 2 to this Regulation, even if the conformity assessment is no longer carried out. The importer shall keep a copy of the EU declaration of conformity for at least 10 years after the explosives are placed on the market. Where the manufacturer has appointed an authorised representative to perform certain of his tasks under the law and this Regulation, the period of retention of the EU declaration of conformity shall apply to him mutatis mutandis to the manufacturer.
§ 8
Rules on the placing of the CE marking
(1) The CE marking according to the directly applicable European Union3) must be placed on the explosive before being placed on the market, directly on the explosive itself. If the size, shape or nature of the explosive does not permit the placing of the CE marking directly on the explosive, the location of the CE marking on its packaging and on the accompanying documentation shall be sufficient at the same time.
(2) In the case of an explosive manufactured for own use, explosives transported and supplied without packaging, explosives manufactured by a mobile unit preparing explosives at the point of consumption for its direct charge to the corkscrew or produced at the point of shot which is loaded into the corkscrew immediately after its manufacture, the CE marking on the accompanying documentation shall be sufficient.
§ 9
Distributors
Before making an explosive available on the market, the distributor shall verify in particular that:
(a) the explosive bears the CE marking;
(b) the explosive shall bear the information and identification particulars provided for in Article 6 (3) of the Act and Article 10 (1) of this Regulation;
(c) the explosive shall bear the importer's identification and contact details pursuant to Article 8 (4) of the Act and Article 10 (2) of this Regulation;
(d) the explosive shall be accompanied by instructions for its use and proof of its characteristics pursuant to Article 6 (3) or Article 8 (2) (a) (4) of the Act and Article 10 (3) of this Regulation.
§ 10
Information and identification of explosives and accompanying documents
(1) The information and identification information on explosives and the manufacturer's identification and contact details pursuant to Article 6 (3) of the Act is:
(a) markings for traceability purposes in accordance with the requirements set out in Part II of Annex 3 to this Regulation in respect of an explosive subject to traceability in accordance with Part I of Annex 3 to this Regulation; this marking shall bear the explosive and each of its smallest packages unless Part II of Annex 3 to this Regulation provides otherwise;
(b) the batch or series number or, where appropriate, a similar indication enabling the identification of the explosive, the name or trade name or registered trade mark of the manufacturer and his address for service, in the Czech language, unless it is a traceability explosive in accordance with Part I of Annex 3 to this Regulation; This information shall be provided directly by the explosive if the size, shape or method of execution of the explosive does not permit the placing of such information directly on the explosive, the particulars shall be indicated on its packaging or accompanying documentation.
(2) The identification and contact details which the importer is required to indicate on the explosive pursuant to Article 8 (4) of the Act are the name, trade name or registered trade mark of the importer and his address for service in the Czech language. If the size, shape or method of execution of the explosive does not permit the placing of such data directly on the explosive, the particulars shall be indicated on its packaging or accompanying documentation.
(3) Where the law provides for an obligation to ensure that the product is accompanied by instructions and safety information, it shall, for the purposes of this Regulation, include instructions for the use of the explosive and proof of its properties.
§ 11
Specific requirements for notified bodies
The notified body may not be a body belonging to an economic association or professional association associated with those involved in the manufacture, making available on the market or use of explosives.
§ 12
Formal deficiencies justifying the adoption of safeguard measures
The formal deficiencies which may justify a decision to prohibit the placing on the market, making available on the market or use by the manufacturer for its own use or, where appropriate, to withdraw the explosive from the market or recall pursuant to Section 50 (5) of the Act are as follows:
(a) the explosive bears the CE marking contrary to the law, to this Regulation or to the directly applicable regulation of the European Union, or the explosive has not been affixed at all;
(b) the identification number of the notified body has been affixed to or has not been affixed to the CE marking in breach of law or of this Regulation;
(c) the EU declaration of conformity has been drawn up in contravention of the law or of this Regulation or has not been drawn up at all;
(d) the explosive is missing or incomplete from the technical documentation referred to in this Regulation;
(e) the explosive does not bear the particulars referred to in Article 10 (1) or (2) of this Regulation; or
(f) the explosive is not accompanied by instructions for its use or proof of its performance pursuant to Article 10 (3) of this Regulation.
§ 13
Transitional provisions
(1) Explosives placed on the market before the date of entry into force of this Regulation which comply with the requirements of Government Regulation No 358 / 2001 Coll., laying down technical requirements for explosives for civil use when they are placed on the market, as effective before the date of entry into force of this Regulation, shall be considered as explosives placed on the market under this Regulation.
(2) The EC type-examination certificate, certificate of conformity and decision issued by an authorised or notified person in accordance with Annex 2 to Government Regulation No 358 / 2001 Coll., as effective before the date of entry into force of this Regulation, shall be considered as an EU type-examination certificate, certificate of conformity or decision under this Regulation.
(3) Explosives complying with the requirements of Government Regulation No. 84 / 2013 Coll., on requirements for unambiguous marking of explosives for civil use, as effective before the date of entry into force of this Regulation, shall be deemed to comply with the requirements of § 10 (1) (a) of this Regulation.
§ 14
Repeal
They shall be deleted:
1. Government Decree No. 358 / 2001 Coll., laying down technical requirements for explosives for civil use when placed on the market.
2. Government Decree No. 416 / 2003 Coll., amending Government Decree No. 358 / 2001 Coll., laying down technical requirements for explosives for civil use when they are placed on the market.
§ 15
Efficacy
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Prime Minister:
Sobotka v. r.
Minister for Industry and Trade:
Ing. Mládek, CSc., v. r.

Příloha č. 1

Annex No 1 to Government Regulation No 97 / 2016 Coll.
Basic technical requirements
I.
General requirements
1. Each explosive must be designed, constructed and supplied in such a way that, until it is used, it represents a minimum threat to human life and health and that damage to property and the environment is avoided under normal foreseeable conditions, in particular with regard to safety rules and working rules.
2. Each explosive shall achieve the functional characteristics specified by the manufacturer in order to ensure maximum safety and reliability.
3. Each explosive shall be designed and constructed in such a way that it can be disposed of by appropriate techniques in such a way as to minimise environmental effects.
II.
Specific requirements
1. In the case of explosives, they shall be assessed or tested in particular for the following information and characteristics:
(a) design and characteristics, including chemical composition, degree of homogenisation, dimensions and granulometric composition, where appropriate;
(b) the physical and chemical stability of the explosive under all ambient conditions to which it may be subjected;
(c) sensitivity to impact and friction;
(d) the compatibility of all components with regard to their physical and chemical stability;
(e) chemical purity of the explosive;
(f) the resistance of an explosive to moisture if the explosive is intended for use in moisture or wet conditions and if its safety or reliability can be adversely affected by moisture;
(g) resistance to low and high temperatures when the explosive is intended to be stored or used at such temperatures and if its safety or reliability may be adversely affected by cooling or heating of one of its constituents or explosives as a whole;
(h) the suitability of an explosive for use in a hazardous environment (e.g. explosive mining gases, hot articles) if the explosive is intended for use in such conditions;
(i) safety features against premature or unintentional initiation or ignition;
(j) the correct charging and operation of the explosive when used for the intended purpose;
(k) appropriate guidance and, where necessary, labelling as regards safe handling, storage, use and disposal;
(l) the ability of the explosive, its packaging and other components to withstand decomposition during storage up to the manufacturer's date of consumption; and
(m) the specification of all equipment and equipment necessary for the reliable and safe operation of the explosive.
2. Each explosive shall be tested under realistic conditions. If this cannot be done by laboratory, tests shall be carried out under the conditions under which the explosive is to be used.
3. Individual explosive groups shall also meet the following requirements:
3.1 Explosives
(a) the proposed method of initiation shall ensure safe, reliable and complete detonation of the explosive or any other explosive transformation where necessary. In the case of black dust, deflagration should be checked,
(b) explosives in the form of charges shall transmit detonation safely and reliably from one end of the charge of such charges to the other;
(c) crops resulting from the explosion of mining explosives may contain carbon monoxide, nitrogen oxides, other gases, steam or flyby solid residues only in quantities which do not damage health under normal working conditions.
3.2 Lightning, safety fuses and shock pipes
(a) the packaging of flashbulbs, safety matches and shock tubes must have the necessary mechanical strength and ensure adequate protection of the explosive charge during normal mechanical stress;
(b) the burning times of the safety matches must be marked and must be reliably observed;
(c) flashbulbs shall be able to be reliably initiated, have sufficient initiation power and comply with storage requirements even under special climatic conditions.
3.3 Detonators (including timed detonators), lightning arresters
(a) detonators shall reliably initiate detonation of the explosives for which they are intended under all foreseeable conditions of use;
(b) lightning arresters shall ensure reliable transmission of detonation;
(c) the initiation force shall not be adversely affected by moisture;
(d) the delay times of the time detonators shall be such that the probability of overlapping between adjacent time levels is negligible;
(e) the electrical characteristics of the electric detonators shall be indicated on their packaging (safe current, safe pulse, positive current, resistance, positive pulse);
(f) the electric detonator conductors shall be reliably insulated and their mechanical strength, including the fixture in the detonator itself, shall be consistent with the intended use.
3.4. Bullets and solid fuels
(a) such substances may not detonate under the prescribed conditions of use;
(b) free cash (for example, on the basis of intracellulose) shall, where necessary due to their physical and chemical nature, be stabilised against degradation;
(c) solid fuels in moulded or cast forms shall not contain any undesirable cracks or other defects which adversely affect their operation.

Příloha č. 2

Annex No 2 to Government Regulation No 97 / 2016 Coll.
Conformity assessment procedures
Module B
EU type-examination
1. the EU type-examination is the part of the conformity assessment procedure in which the notified body examines the technical design of the explosive and verifies and confirms that the technical design of the explosive complies with the essential technical requirements applicable to it.
2. EU type-examination shall be carried out by:
(a) an assessment of the suitability of the technical design of the explosive by reviewing the technical documentation and supporting evidence referred to in point 3; and
(b) a sample examination of a complete product representative of the production envisaged (combination of the production type and the design type).
3. The manufacturer shall submit an application for EU type-examination to the single notified body which he has chosen.
The application shall contain:
(a) the name or business name, registered office and identification number of the manufacturer, if assigned, and if the application is submitted by an authorised representative, the same particulars;
(b) a statement that the same application has not been lodged with another notified body;
(c) the technical documentation referred to in Article 6;
(d) samples representative of the production envisaged; the notified body may require additional samples if necessary to carry out the test programme; and
(e) supporting evidence of the adequacy of the solution adopted in the technical proposal. Such supporting evidence shall refer to all relevant documents used, in particular where the relevant harmonised standards have not been fully applied. The supporting evidence shall include, where appropriate, the results of the tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer or another test laboratory on his behalf and under his responsibility.
4. Notified body
(a) examine the technical documentation and supporting evidence for the explosive in order to assess the adequacy of its technical proposal;
(b) verify for explosive samples that they have been manufactured in conformity with the technical documentation and identify the elements which have been designed in accordance with the provisions of the relevant harmonised standards as well as those which have been designed in accordance with other relevant technical specifications;
(c) carry out, or have carried out, appropriate examinations and tests to verify that the relevant harmonised standards have been applied correctly if the manufacturer has chosen a solution according to those standards;
(d) carry out or have carried out appropriate examinations and tests to verify that the solutions to other relevant technical specifications comply with the relevant basic technical requirements, unless the manufacturer has used the solutions to the relevant harmonised standards; and
(e) agree with the manufacturer where the examinations and tests will be carried out.
5. The notified body shall draw up an evaluation report recording the activities carried out under point 4 and their results. Without prejudice to its information obligations towards the notifying authority, the notified body shall publish the content of the report, in full or in part, only with the agreement of the manufacturer.
6. If the type complies with the requirements of this Regulation which apply to the explosive in question, the notified body shall issue an EU-type examination certificate to the manufacturer. This certificate shall contain:
(a) identification details of the explosive manufacturer;
(b) the particulars necessary to identify the approved type;
(c) the conclusions of the examination; and
(d) the conditions of validity of the certificate, if necessary.
The EU type-examination certificate may be accompanied by one or more annexes. The EU-type examination certificate and its annexes shall contain all relevant information to enable the assessment of the conformity of the manufactured explosive with the tested type and to carry out an appropriate check at all stages of the life cycle of the explosive. Where the type does not comply with the relevant requirements of this Regulation, the notified body shall not issue an EU-type examination certificate and shall inform the applicant accordingly, stating in detail the reasons for the refusal.
7. The notified body shall ensure that it is aware of any changes to the generally accepted state of the art which would suggest that the type approved may no longer comply with the relevant essential technical requirements and shall decide whether such changes require additional investigations. Where investigations require, the notified body shall inform the manufacturer accordingly. The manufacturer shall inform the notified body which keeps the technical documentation relating to the EU-type examination certificate of any modifications to the approved type which may affect the conformity of the explosive with the essential technical requirements or the conditions of validity of the certificate. These adaptations require additional approval in the form of an addendum to the original EU-type examination certificate.
8. The European Commission, the Member States of the European Union and other notified bodies may, upon request, obtain a copy of the EU-type examination certificate and its additions. The European Commission and the Member States of the European Union may, upon request, obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU-type examination certificate by the expiry date of its validity as well as its annexes, additions and technical file, including any additional documentation submitted by the manufacturer.
9. The manufacturer shall keep the technical documentation, a copy of the EU-type examination certificate, its annexes and additions for at least 10 years after the explosive has been placed on the market or used for its own use.
Module C2
Conformity to type based on internal production control together with supervised product checks at random intervals
1. Conformity to type based on internal production control, together with checks on products under supervision at random intervals, shall be part of a conformity assessment procedure at which the manufacturer fulfils the obligations set out in points 2 to 4 and ensures and declares on his own responsibility that the explosive is in conformity with the type described in the EU-type examination certificate and meets the essential technical requirements applicable to it.
2. Production
The manufacturer shall take all necessary measures to ensure that the manufacturing process and its control ensure compliance of the manufactured explosive with the type described in the EU-type examination certificate and with the requirements of this Regulation which apply to it.
3. Product checks
The notified body selected by the manufacturer shall carry out checks on the explosive or shall have such checks carried out at random intervals which it shall determine in order to verify the quality of the internal checks on the explosive, taking into account, inter alia, the technological complexity of the explosives and the quantity produced. Before placing on the market or using it by the manufacturer for his own use, the notified body shall take the necessary sample of the finished explosive from the manufacturer, which shall be examined and subjected to the appropriate tests set out in the relevant parts of the harmonised standards or equivalent tests set out in other relevant technical specifications to verify the conformity of the explosive with the type described in the EU-type examination certificate and the relevant requirements of this Regulation. If the sample does not reach an acceptable level of quality, the notified body shall take appropriate measures. The sampling procedure used is to determine whether the production process of the explosive in question is carried out within acceptable limits to ensure conformity with the type. The manufacturer shall place the identification number of the notified body on the explosive during the manufacturing process under the responsibility of the notified body concerned.
4. CE marking and EU declaration of conformity
4.1. The manufacturer shall place the CE marking on each individual explosive which is in conformity with the type described in the EU-type examination certificate and meets the relevant requirements of this Regulation.
4.2 The manufacturer shall draw up a written EU declaration of conformity for each type of explosive and keep it for at least 10 years after the explosive has been placed on the market or used for its own use.
Module D

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Regulation Information

CitationGovernment Decree No. 97 / 2016 Coll., on Technical Requirements for Explosives
Regulation TypeRegulation
Author-
CollectionCode of Laws
Date of Promulgation06.04.2016
Effective from20.04.2016
Effective until-
Status Valid
The regulation text is for informational purposes only.
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