Government Decree No 358 / 2001 Coll.
Government Regulation laying down technical requirements for explosives for civil use when placed on the market
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Regulation
Effective from 01.01.2002
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358
GOVERNMENT REGULATION
of 29 August 2001
laying down technical requirements for explosives for civil use when placed on the market
The Government mandates pursuant to Section 22 of Act No. 22 / 1997 Coll., on the technical requirements for products and on the amendment and addition of certain laws, as amended by Act No. 71 / 2000 Coll., ("the Act ') to implement Sections 11 (2), 12 (1) and (4) and 13 (2) of the Act:
(1) This Regulation lays down, in accordance with European Community law, technical requirements for explosives for civil use when they are placed on the market.
(2) Explosives for the purposes of this Regulation shall mean substances and articles covered by a separate law.2)
(1) Explosives are specified products under Section 12 (1) of the Act.
(2) Explosives must comply with the essential safety requirements set out in Annex 1 to this Regulation.
(3) The essential requirements set out in Annex 1 to this Regulation shall be deemed to be met if explosives comply with harmonised Czech technical standards or, where appropriate, with foreign technical standards transposing harmonised European standards in the Member States of the European Union (Section 4a of the Law).
(4) All explosives shall comply with the essential safety requirements set out in Annex 1 to this Regulation as long as they are to be handled. Explosives not complying with this requirement shall be destroyed.
(1) Before placing an explosive on the market, the manufacturer shall ensure conformity assessment (Section 12 (3) of the Act) with the essential safety requirements set out in Annex 1 to this Regulation in accordance with the following procedures:
(a) EC type-examination according to Part I of Annex No 2 to this Regulation and at the choice of the manufacturer
1. type-approval pursuant to Part II of Annex 2 to this Regulation;
2. the quality assurance of production according to Part III of Annex 2 to this Regulation;
3. product quality assurance in accordance with Part IV of Annex 2 to this Regulation; or
4. verification of individual products as specified in Part V. of Annex 2 to this Regulation;
or
(b) verification of the unit according to Part VI of Annex 2 to this Regulation.
(2) For explosives covered by the relevant international contract (4) which comply with the requirements of this Regulation, including conformity assessment, the manufacturer shall affix the CE marking (5).
(3) The CE marking shall be carried out on explosives in such a way as to be visible, legible and durable, directly on explosives themselves, or, if this is not possible, on an identification plate affixed to explosives or on packaging. The label shall be so manufactured as not to allow re-use. It shall be prohibited to place on explosives a marking (s) which may be interchangeable with the CE marking.
(4) The conformity assessment referred to in paragraph 1 and the location of the CE conformity marking may ensure that, where this is further provided for in this Regulation, an authorised representative [Paragraph 2 (f) of the Act].
Notification of the imposition of a safeguard measure
In the event that a protective measure has been imposed on explosives under a special legislation, 6) the notification of the decision to impose a protective measure under Article 7 (8) of the Act shall state whether the non-compliance was caused by:
(a) failure to meet the essential requirements referred to in Article 2 (2);
(b) incorrect application of the technical standards referred to in Article 2 (3); or
(c) shortcomings in the technical standards referred to in Article 2 (3).
Authorisations (Article 11 of the Act) for conformity assessment may be granted only to legal persons who comply with the minimum requirements set out in Annex 3 to this Regulation.
(1) Explosives put into circulation before the date of entry into force of this Regulation in accordance with existing legislation shall be regarded as being placed on the market under this Regulation.
(2) Pending the entry into force of Paragraph 3 (1), (2) and (3), the declaration of conformity referred to in Article 3 (5) is required for explosives, irrespective of their country of origin.
(1) This Regulation shall enter into force on 1 January 2002, except:
(a) the provisions of Article 3 (1), (2) and (3) of this Regulation which take effect on the date of the publication of the sectoral annex "Explosives" to the Protocol to the Europe Agreement on Conformity Assessment and Acceptance of Industrial Products in the Collection of International Contracts, but not later than the date of entry into force of the Treaty of Accession of the Czech Republic to the European Union; and
(b) the provisions of Paragraph 3 (4) and the provisions of the Annexes to this Regulation in so far as they concern an authorised representative who shall take effect on the date of entry into force of the Treaty of Accession of the Czech Republic to the European Union.
(2) Paragraph 3 (5) expires on the date of entry into force of the Treaty of Accession of the Czech Republic to the European Union.
Prime Minister:
Ing. Zeman v. r.
Deputy Prime Minister and Minister of Industry and Trade:
Ing. Grégr v. r.
Příloha č. 1
Annex No 1 to Government Decree No 358 / 2001 Coll.
Basic safety requirements
I. General requirements
1. Each explosive must be designed, constructed and supplied in such a way that, under normal and foreseeable conditions, in particular with regard to safety regulations and normal procedures, it will, until it is used, as little as possible, endanger the safety of human life and health and prevent damage to property and the environment.
2. Each explosive shall have the performance specified by the manufacturer in order to ensure maximum safety and reliability.
3. Each explosive shall be designed and manufactured in such a way that it can be disposed of in such a way as to minimise the environmental impact of any appropriate technique.
II. Specific requirements
1. Each explosive shall be tested under actual conditions. If this is not possible in the laboratory, tests shall be carried out under the conditions under which the explosive is to be used. The following information and, where appropriate, properties should be tested and considered as a minimum
(a) description and characteristics of the explosive, including chemical composition, degree of homogenisation and, where appropriate, size and granularity;
(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 integrity of the explosive against the influence of water if the explosive is intended for use in a wet or wet environment and its safety or reliability may be adversely affected by water;
(g) resistance to low and high temperatures where the explosive is intended to be stored or used at such temperatures and its safety or reliability may be adversely affected by the cooling or heating of a component or explosive as a whole;
(h) the suitability of an explosive for use in a hazardous environment (e.g. explosive atmospheres, hot objects) if the explosive is intended for use in such conditions;
(i) security against premature or involuntary initiation or ignition;
(j) the correct charging and operation of the explosive when used for a specified purpose;
(k) appropriate instructions and, where necessary, indications indicating the safe handling, storage, use and disposal in the official language or languages of the recipient Member State;
(l) the ability of the explosive, its packaging and other components to withstand damage during storage up to the manufacturer's date of consumption,
(m) identification of all equipment and equipment necessary for the reliable and safe operation of the explosive.
2. Each group of explosives shall also meet at least the following requirements:
A. Explosives
(a) The proposed method of initiation shall ensure reliable and complete detonation or deflagration of the explosive. 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 marker to the other.
(c) The residues resulting from the explosion of mine explosives may contain carbon monoxide, nitrogen oxides and other gases, vapours or flagged solid residues only in quantities which do not damage health under normal operating conditions.
B. Lightning, matches and shock pipes
(a) The packaging of flashbulbs and matches shall have the necessary mechanical strength and ensure adequate protection of the explosive charge in normal mechanical stress. It is essential that impact tubes do not initiate explosives with their function and have adequate tensile strength.
(b) The burning times of the match shall be marked and shall be reliably observed.
(c) Lightning heads must be capable of reliable initiation, have sufficient initialisation capability and comply with storage requirements even under special climatic conditions.
C. Detonators (including time detonators) and lightning arresters
a) The detonators shall reliably initiate detonation of the explosives for which they are intended under all foreseeable conditions of use.
(b) Lightning arresters shall be reliably initiated.
(c) The starting force shall not be adversely affected by moisture.
(d) Time delay of time detonators shall be such that the probability of overlapping adjacent time levels is within the permitted tolerance.
(e) The electrical characteristics of the electric detonators shall be indicated on the packaging (i.e. safe current, resistance and others).
f) It is required that the insulation of electrical detonator supply conductors is mechanically fixed, climate-resistant and electrical penetration-resistant, under conditions of use. It shall allow for a firm attachment to the detonator.
D. Explosives and solid fuels
(a) such substances shall not detonate when used in accordance with the intended purpose.
(b) The ammunition (for example, on the basis of nitrocellulose) shall, if necessary, be stabilised against decomposition.
(c) Solid fuels in moulded or cast form shall not contain any undesirable cracks or air bubbles which adversely affect their operation.
Příloha č. 2
Annex No 2 to Government Decree No 358 / 2001 Coll.
Conformity assessment procedures
I. EC type-examination
1. EC type-examination is a procedure whereby the authorised person verifies and certifies by a certificate that the sample representing the production under consideration complies with the requirements of this Regulation which apply to it.
2. The application for EC type-examination shall be submitted by the manufacturer or his authorised representative to the authorised person.
The application shall contain:
- the name and address of the manufacturer and, if the application is submitted by his authorised representative, his name and address,
- a written declaration that the application has not been lodged with another authorised person,
- the technical documentation referred to in point 3.
The applicant shall provide the authorised person with a sample representing the intended production (type). If required by the test programme, the authorised person may request additional samples.
3. The technical documentation shall make it possible to assess the conformity of the product with the requirements of the Regulation. Where necessary for conformity assessment, it shall contain data on the design, manufacture and function of the product to the following extent:
- a general description of the type,
- conceptual designs, manufacturing drawings and diagrams of sub-assemblies, circuits and others,
- descriptions and comments necessary to understand the drawings and diagrams and functions of the product,
- a list of standards which have been applied in whole or in part and a description of the solutions adopted to meet the essential requirements of the Regulation,
- the results of the design calculations carried out, the examinations carried out and others,
- test protocols.
4. Authorised Person
4.1 shall examine the technical documentation, verify that the type has been manufactured in conformity with the documentation and identify the elements which have been designed in accordance with the relevant provisions of the standards as well as those which have been designed without the application of the relevant provisions of those standards,
4.2 carry out or have carried out appropriate examinations and tests to check that, where the standards have not been applied, the solution adopted by the manufacturer complies with the essential requirements of this Regulation;
4.3 carry out or have carried out the appropriate examinations and tests necessary to check whether those standards have actually been applied where the manufacturer has decided to apply the relevant standards,
4.4 agrees with the applicant where the examinations and the necessary tests will be carried out.
5. If the type complies with the relevant provisions of this Regulation, the authorised person shall issue the applicant an EC type-examination certificate. The certificate shall include the name and address of the manufacturer, the conclusions of the test and the necessary data to identify the approved type.
The certificate shall be accompanied by a list of the relevant parts of the technical documentation, one copy of the list being archived by the authorised person.
If the authorised person does not issue an EC type-examination certificate to the manufacturer or his authorised representative, he shall state the reasons for such refusal.
6. The applicant shall inform the authorised person keeping the technical documentation relating to the EC type-examination certificate of any modifications to the approved product for which additional approval has to be granted, provided that such changes may affect compliance with the essential requirements or the prescribed conditions for use of the product. This additional approval shall be carried out in the form of a supplement to the original EC type-examination certificate.
7. The authorised person shall notify the other authorised persons of the relevant information concerning the EC type-examination certificates and the additions issued and cancelled.
8. Other authorised persons may receive copies of EC type-examination certificates and additions thereto. The annexes to certificates shall be made available at any time to other authorised persons.
9. The manufacturer or his authorised representative shall, together with the technical documentation, keep copies of the EC type-examination certificates and additions thereto for at least 10 years from the manufacture of the last piece of the product.
Where the manufacturer or importer is not known, the technical documentation shall be kept by the person who places the product on the market.
II. Conformity to type
1. The procedure whereby the manufacturer or his authorised representative ensures and declares that the explosive in question is identical to the type described in the EC type-examination certificate and meets the relevant requirements of this Regulation.
The manufacturer shall affix the CE marking to each product and draw up a written declaration of conformity for the type of explosive concerned.
2. The manufacturer shall take all necessary measures to ensure that the manufacturing process ensures conformity of manufactured products with the type described in the EC type-examination certificate and with the relevant safety requirements of this Regulation.
3. The manufacturer or his authorised representative shall keep a copy of the certificate of conformity for at least 10 years after the last piece of the product has been manufactured.
Where the manufacturer is not known, the technical documentation shall be kept by the person placing the product on the market.
4. The authorised person shall carry out the product inspection tests at specified intervals. The authorised person shall take on-the-spot the necessary samples of the finished product and carry out their verification and the corresponding tests referred to in the relevant standards or tests equivalent to those to verify the conformity of the product with the corresponding requirements of this Regulation. If one or more samples of the test product fail, the authorised person shall take appropriate action. During the production process, the manufacturer attaches the product identification symbol of the authorised person.
III. Quality assurance of production
1. The procedure whereby a manufacturer who fulfils the obligations set out in point 2 ensures and declares that the explosives in question are in conformity with the type described in the EC type-examination certificate and comply with the requirements of this Regulation.
The manufacturer shall affix the CE marking to each explosive and draw up a written declaration of conformity for the type of explosive concerned. The CE marking shall be accompanied by an indication of the authorised person responsible for supervision in accordance with point 4 on the label.
2. The manufacturer shall use an approved quality system for production, final product inspection and testing according to the requirements set out in point 3 and shall be subject to the surveillance referred to in point 4.
3. Quality system
3.1 The application for assessment of the quality system for the explosive in question shall be submitted by the manufacturer to an authorised person chosen by him.
The application shall contain:
- all necessary information for the category of explosive,
- documentation relating to the quality system,
- the technical documentation of the approved type and a copy of the EC type-examination certificate.
3.2 The quality system shall guarantee compliance of the explosive with the type described in the EC type-examination certificate and with the requirements of this Regulation which apply to it.
All elements, requirements and measures adopted by the manufacturer shall be systematically and properly documented in the form of principles, procedures and instructions. The quality system documentation shall allow a uniform interpretation of the quality programmes, plans, manuals and quality records.
It shall contain in particular an appropriate description of:
- the quality objectives and the organisational structure, responsibilities and powers of management with regard to the quality of explosives,
- the manufacturing, quality control, quality assurance and quality assurance procedures, procedures and systematic activities to be used,
- verifications and tests to be carried out before, during and after production and the frequency of their implementation,
- quality records such as inspection reports and calibration data, qualification records for relevant personnel and others,
- means of monitoring the achievement of the required quality of the explosive and the effective functioning of the quality system.
3.3 The authorised person shall assess the quality system and decide whether it meets the requirements referred to in point 3.2. For quality systems which comply with the relevant harmonised standard, they shall assume compliance with these requirements. The search group shall have at least one member with experience in assessing the production technology. The evaluation shall include an inspection visit to the manufacturer's workplace. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the inspection and the justification for the assessment decision.
3.4 The manufacturer shall take measures to ensure that the approved system remains appropriate and effective.
The manufacturer or his authorised representative shall inform the authorised person who approved the quality system of any intended modification to that system.
The authorised person shall assess the proposed changes and decide whether the modified quality system will continue to comply with the requirements of paragraph 3.2 or whether a new assessment is necessary.
They shall notify the manufacturer of their decision. The notification shall contain the conclusions of the verification and a reasoned assessment decision.
4. Responsibilities of the authorised person for supervision
4.1 The purpose of supervision is to ensure that the manufacturer complies adequately with the obligations arising from the approved quality system.
4.2 For inspection purposes, the manufacturer shall permit the authorised person to enter the production premises where the checks and tests are carried out and into the storage premises and shall provide him with all necessary information, in particular:
- documentation relating to the quality system,
- quality records such as inspection reports and test data, calibration data, qualification records of relevant personnel and others.
4.3 The authorised person shall regularly carry out checks to ensure that the manufacturer maintains and uses the quality system.
The authorised person shall transmit the control report to the manufacturer.
4.4 In addition, the authorised person may make unannounced visits to the manufacturer. During these visits, the authorised person may, if necessary, carry out or have tests carried out to verify the proper functioning of the quality system. The authorised person shall provide the manufacturer with a report of his visit and, if tests have been carried out, with test reports.
5. The manufacturer shall, for a period of at least 10 years from the date of manufacture of the last piece of explosive, keep it at the disposal of the public authorities.
- the documentation referred to in the second indent of point 3.1,
- documentation of the modifications referred to in the second paragraph of point 3.4,
- decisions and reports of the authorised person referred to in the last paragraph of points 3.4, 4.3 and 4.4.
6. Each authorised person shall provide the other authorised persons with adequate information concerning quality system approvals issued and withdrawn.
IV. Quality assurance of the product
1. The procedure whereby a manufacturer meeting the obligations set out in point 2 shall ensure and declare that explosives are identical to the type described in the EC type-examination certificate. The manufacturer shall affix the CE marking to each explosive and draw up a written declaration of conformity for the type of explosive concerned. The CE marking shall be accompanied by the designation of the authorised person responsible for supervision referred to in point 4 on the label.
2. The manufacturer shall use the approved quality system for the exit inspection and testing of finished explosives in accordance with the requirements set out in point 3 and shall be subject to surveillance in accordance with point 4.
3. Quality system
3.1 The manufacturer shall submit an application for assessment of his quality system for the explosives in question to an authorised person of his choice.
The application shall contain:
- all necessary information for the category of explosives under consideration,
- documentation relating to the quality system,
- the technical documentation of the approved type and a copy of the EC type-examination certificate.
3.2 Within the quality system, each explosive shall be checked and adequately tested according to the requirements of the relevant standards or equivalent tests shall be carried out to verify its conformity with the corresponding requirements of this Regulation. All elements, requirements and measures adopted by the manufacturer shall be systematically and properly documented in the form of principles, procedures and instructions. The quality system documentation shall allow a uniform interpretation of the quality programmes, plans, manuals and quality records.
It shall contain in particular an appropriate description of:
- quality objectives, organisational structure, responsibilities and competence of management in terms of product quality,
- verifications and tests to be carried out after manufacture,
- means for monitoring the effective functioning of the quality system,
- quality records such as inspection reports and test data, calibration data, qualification records of relevant personnel and others.
3.3 The authorised person shall assess the quality system and decide whether it meets the requirements referred to in point 3.2.
The search group shall have at least one member who has gained experience in the product technology as an assessor. The evaluation shall include an inspection visit to the manufacturer's workplace.
The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the verification and the justification for the assessment decision.
3.4 The manufacturer shall ensure that the obligations arising from and the maintenance of the approved quality system are fulfilled and that they are effective.
The manufacturer or his authorised representative shall keep the authorised person who approved the quality system informed of any intended change in the quality system.
The authorised person shall assess the proposed changes and decide whether the changed quality system will continue to comply with the requirements of point 3.2 or whether a new assessment is necessary. They shall communicate their decision to the manufacturer. The notification shall contain the conclusions of the verification and the justification for the assessment decision.
4. Responsibilities of the authorised person for supervision
4.1 The purpose of supervision is to ensure that the manufacturer complies adequately with the obligations arising from the approved quality system.
4.2 For inspection purposes, the manufacturer shall authorise the authorised person to enter the production premises, the inspection and testing areas and the storage areas and shall provide him with all necessary information, in particular:
- documentation relating to the quality system,
- technical documentation,
- quality records such as inspection reports and test data, calibration data, qualification records of relevant personnel and others.
4.3 The authorised person shall regularly carry out checks to ensure that the manufacturer maintains and uses the quality system.
The authorised person shall provide the manufacturer with a control report.
4.4 The authorised person shall be entitled to make unannounced visits to the manufacturer. During these visits, the authorised person may, if necessary, carry out or have tests carried out to verify the proper functioning of the quality system. The authorised person shall provide the manufacturer with a visit report and, where tests have been carried out, with test reports.
5. The manufacturer shall keep the explosives at the disposal of the public authorities for at least 10 years from the date of manufacture of the last piece of explosive.
- the documentation referred to in the third indent of point 3.1,
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Regulation Information
| Citation | Government Decree No 358 / 2001 Coll., laying down technical requirements for explosives for civil use when placed on the market |
|---|---|
| Regulation Type | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 05.10.2001 |
|---|---|
| Effective from | 01.01.2002 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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