Annexes to COM(2011)771 - Harmonisation of the laws of the Member States relating to the making available on the market and supervision of explosives for civil uses - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
dossier | COM(2011)771 - Harmonisation of the laws of the Member States relating to the making available on the market and supervision of ... |
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document | COM(2011)771 ![]() |
date | February 26, 2014 |
(5) OJ L 127, 29.4.2004, p. 73.
(6) OJ L 218, 13.8.2008, p. 30.
(7) OJ L 218, 13.8.2008, p. 82.
(8) OJ L 10, 14.1.1997, p. 13.
(9) OJ L 178, 28.6.2013, p. 27.
(10) OJ L 256, 13.9.1991, p. 51.
(11) OJ L 316, 14.11.2012, p. 12.
(12) OJ L 82, 22.3.1997, p. 1.
(13) OJ L 55, 28.2.2011, p. 13.
(14) OJ L 94, 5.4.2008, p. 8.
ANNEX I
ARTICLES CONSIDERED IN THE RELEVANT UNITED NATIONS RECOMMENDATIONS TO BE PYROTECHNIC OR AMMUNITION
UN No | NAME and DESCRIPTION | CLASS/DIVISION | GLOSSARY (to be used as a guide for information only) |
Group G | |||
0009 | Ammunition, Incendiary with or without burster, expelling charge or propelling charge | 1.2 G | Ammunition Generic term related mainly to articles of military application consisting of all kind of bombs, grenades, rockets, mines, projectiles and other similar devices. Ammunition, Incendiary Ammunition containing incendiary substance. Except when the composition is an explosive per se, it also contains one or more of the following: a propelling charge with primer and igniter charge; a fuze with burster or expelling charge. |
0010 | Ammunition, Incendiary with or without burster, expelling charge or propelling charge | 1.3 G | See Entry for UN No 0009 |
0015 | Ammunition, Smoke with or without burster, expelling charge or propelling charge | 1.2 G | Ammunition, Smoke Ammunition containing smoke-producing substance. Except when the substance is an explosive per se, the ammunition also contains one or more of the following: a propelling charge with primer and igniter charge; a fuze with burster or expelling charge. |
0016 | Ammunition, Smoke with or without burster, expelling charge or propelling charge | 1.3 G | See Entry for UN No 0015 |
0018 | Ammunition, Tear-producing with burster, expelling charge or propelling charge | 1.2 G | Ammunition, Tear-producing with burster, expelling charge or propelling charge Ammunition containing tear-producing substance. It also contains one or more of the following: a pyrotechnic substance; a propelling charge with primer and igniter charge; a fuze with burster or expelling charge. |
0019 | Ammunition, Tear-producing with burster, expelling charge or propelling charge | 1.3 G | See Entry for UN No 0018 |
0039 | Bombs, photo-flash | 1.2 G | Bombs Explosive articles which are dropped from aircraft. They may contain a flammable liquid with bursting charge, a photo-flash composition or a bursting charge. The term includes: bombs, photo-flash. |
0049 | Cartridges, Flash | 1.1 G | Cartridges, Flash Articles consisting of a casing, a primer and flash powder, all assembled in one piece ready for firing. |
0050 | Cartridges, Flash | 1.3 G | See Entry for UN No 0049 |
0054 | Cartridges, Signal | 1.3 G | Cartridges, Signal Articles designed to fire coloured flares or other signals from signal pistols, etc. |
0066 | Cord, Igniter | 1.4 G | Cord, Igniter Article consisting of textile yarns covered with black powder or another fast burning pyrotechnic composition and of a flexible protective covering; or it consists of a core of black powder surrounded by a flexible woven fabric: It burns progressively along its length with an external flame and is used to transmit ignition from a device to a charge. |
0092 | Flares, Surface | 1.3 G | Flares Articles containing pyrotechnic substances which are designed for use to illuminate, identify, signal or warn. |
0093 | Flares, Aerial | 1.3 G | See Entry for UN No 0092 |
0101 | Fuse, non-detonating | 1.3 G | Fuse/Fuze Although these two words have a common origin (French fusée, fusil) and are sometimes considered to be different spellings, it is useful to maintain the convention that fuse refers to a cord-like igniting device whereas fuze refers to a device used in ammunition which incorporates mechanical, electrical, chemical or hydrostatic components to initiate a train by deflagration or detonation. Fuse, instantaneous, non-detonating (quick-match) Article consisting of cotton yarns impregnated with fine black powder (quickmatch). It burns with an external flame and is used in ignition trains for fireworks, etc. |
0103 | Fuse, Igniter, tubular, metal clad | 1.4 G | Fuse, igniter, tubular, metal clad Article consisting of a metal tube with a core of deflagrating explosive. |
0171 | Ammunition, illuminating with or without burster, expelling charge or propelling charge | 1.2 G | Ammunition, illuminating with or without burster, expelling charge or propelling charge Ammunition designed to produce a single source of intense light for lighting up an area. The term includes illuminating cartridges, grenades and projectiles; and illuminating and target identification bombs. |
0191 | Signal devices, hand | 1.4 G | Articles designed to produce signals. |
0192 | Signals, railway track, explosive | 1.1 G | See Entry for UN No 0191 |
0194 | Signals, distress, ship | 1.1 G | See Entry for UN No 0191 |
0195 | Signals, distress, ship | 1.3 G | See Entry for UN No 0191 |
0196 | Signals, smoke | 1.1 G | See Entry for UN No 0191 |
0197 | Signals, smoke | 1.4 G | See Entry for UN No 0191 |
0212 | Tracers for ammunition | 1.3 G | Tracers for ammunition Sealed articles containing pyrotechnic substances, designed to reveal the trajectory of a projectile. |
0254 | Ammunition, illuminating with or without burster, expelling charge or propelling charge | 1.3 G | See Entry for UN No 0171 |
0297 | Ammunition, illuminating with or without burster, expelling charge or propelling charge | 1.4 G | See Entry for UN No 0254 |
0299 | Bombs, photo-flash | 1.3 G | See Entry for UN No 0039 |
0300 | Ammunition, incendiary with or without burster, expelling charge or propelling charge | 1.4 G | See Entry for UN No 0009 |
0301 | Ammunition, tear-producing with burster, expelling charge | 1.4 G | See Entry for UN No 0018 |
0303 | Ammunition, smoke with or without burster, expelling charge | 1.4 G | See Entry for UN No 0015 |
0306 | Tracers for ammunition | 1.4 G | See Entry for UN No 0212 |
0312 | Cartridges, signal | 1.4 G | Cartridges, signal Articles designed to fire coloured flares or other signals from signal pistols. |
0313 | Signals, smoke | 1.2 G | See Entry for UN No 0195 |
0318 | Grenades, practice, hand or rifle | 1.3 G | Grenades hand or rifle Articles which are designed to be thrown by hand or to be projected by a rifle. The term includes: Grenades practice, hand or rifle. |
0319 | Primers, tubular | 1.3 G | Primers, tubular Articles consisting of a primer for ignition and an auxiliary charge of deflagrating explosive such as black powder used to ignite the propelling charge in a cartridge case, e.g. cannon. |
0320 | Primers, tubular | 1.4 G | See Entry for UN No 0319 |
0333 | Fireworks | 1.1 G | Fireworks Pyrotechnic articles designed for entertainment. |
0334 | Fireworks | 1.2 G | See Entry for UN No 0333 |
0335 | Fireworks | 1.3 G | See Entry for UN No 0333 |
0336 | Fireworks | 1.4 G | See Entry for UN No 0333 |
0362 | Ammunition, practice | 1.4 G | Ammunition, practice Ammunition without a main bursting charge, containing a burster or expelling charge. Normally it also contains a fuze and a propelling charge. |
0363 | Ammunition, proof | 1.4 G | Ammunition, proof Ammunition containing pyrotechnic substances, used to test the performance or strength of new ammunition, weapon component or assemblies. |
0372 | Grenades, practice, hand or rifle | 1.2 G | See Entry for UN No 0318 |
0373 | Signal devices, hand | 1.4 S | See Entry for UN No 0191 |
0403 | Flares, aerial | 1.4 G | See Entry for UN No 0092 |
0418 | Flares, surface | 1.2 G | See Entry for UN No 0092 |
0419 | Flares, surface | 1.1 G | See Entry for UN No 0092 |
0420 | Flares, aerial | 1.1 G | See Entry for UN No 0092 |
0421 | Flares, aerial | 1.2 G | See Entry for UN No 0092 |
0424 | Projectiles, inert with tracer | 1.3 G | Projectiles Articles such as a shell or bullet which are projected from a cannon or other artillery gun, rifle or other small arm. They may be inert, with or without tracer, or may contain a burster or expelling charge or a bursting charge. The term includes: Projectiles, inert, with tracer; projectiles with burster or expelling charge; projectiles with bursting charge. |
0425 | Projectiles, inert with tracer | 1.4 G | See Entry for UN No 0424 |
0428 | Articles, pyrotechnic for technical purposes | 1.1 G | Articles, pyrotechnic for technical purposes Articles which contain pyrotechnic substances and are used for technical purposes such as heat generation, gas generation, theatrical effects, etc. The term excludes the following articles which are listed separately: all ammunition; cartridges, signal; cutters, cable, explosive; fireworks; flares, aerial; flares, surface; release devices, explosive; rivets, explosive; signal devices, hand; signals, distress; signals, railway track, explosive; signals, smoke. |
0429 | Articles, pyrotechnic for technical purposes | 1.2 G | See Entry for UN No 0428 |
0430 | Articles, pyrotechnic for technical purposes | 1.3 G | See Entry for UN No 0428 |
0431 | Articles, pyrotechnic for technical purposes | 1.4 G | See Entry for UN No 0428 |
0434 | Projectiles with burster or expel-ling charge | 1.2 G | Projectiles Articles such as a shell or bullet which are projected from a cannon or other artillery gun, rifle or other small arm. They may be inert, with or without tracer, or may contain a burster or expelling charge or a bursting charge. The term includes: projectiles, inert, with tracer; projectiles with burster or expelling charge; projectiles with bursting charge. |
0435 | Projectiles with burster or expelling charge | 1.4 G | See Entry for UN No 0434 |
0452 | Grenades, practice, hand or rifle | 1.4 G | See Entry for UN No 0372 |
0487 | Signal, smoke | 1.3 G | See Entry for UN No 0194 |
0488 | Ammunition, practice | 1.3 G | Ammunition, practice Ammunition without a main bursting charge, containing a burster or expelling charge. Normally it also contains a fuze and a propelling charge. The term excludes the following articles which are listed separately: Grenades, practice. |
0492 | Signals, railway track, explosive | 1.3 G | See Entry for UN No 0194 |
0493 | Signals, railway track, explosive | 1.4 G | See Entry for UN No 0194 |
0503 | Air bag inflators, or Airbag modules, or seat belt pre-tensioners, | 1.4 G | |
Group S | |||
0110 | Grenades, practice, hand or rifle | 1.4 S | See Entry for UN No 0318 |
0193 | Signals, railway track, explosive | 1.4 S | See Entry for UN No 0194 |
0337 | Fireworks | 1.4 S | See Entry for UN No 0334 |
0345 | Projectiles, inert with tracer | 1.4 S | Projectiles Articles such as a shell or bullet which are projected from a cannon or other artillery gun, rifle or other small arm. They may be inert, with or without tracer, or may contain a burster or expelling charge or a bursting charge. |
0376 | Primers, tubular | 1.4 S | See Entry for UN No 0319 |
0404 | Flares, aerial | 1.4 S | See Entry for UN No 0092 |
0405 | Cartridges, signal | 1.4 S | Cartridges, Signal Articles designed to fire coloured flares or other signals from signal pistols, etc. |
0432 | Articles, pyrotechnic or technical purpose | 1.4 S |
ANNEX II
ESSENTIAL SAFETY REQUIREMENTS
I. General requirements
1. | Each explosive must be designed, manufactured and supplied in such a way as to present a minimal risk to the safety of human life and health, and to prevent damage to property and the environment under normal, foreseeable conditions, in particular as regards the safety rules and standard practices until it is used. |
2. | Each explosive must attain the performance characteristics specified by the manufacturer in order to ensure maximum safety and reliability. |
3. | Each explosive must be designed and manufactured in such a way that when appropriate techniques are employed it can be disposed of in a manner which minimises effects on the environment. |
II. Special requirements
1. As a minimum, the following information and properties, where appropriate, must be considered or tested:
(a) | design and characteristic properties, including chemical composition, degree of homogeneity and, where appropriate, dimensions and grain size distribution; |
(b) | the physical and chemical stability of the explosive in all environmental conditions to which it may be exposed; |
(c) | sensitiveness to impact and friction; |
(d) | compatibility of all components as regards their physical and chemical stability; |
(e) | the chemical purity of the explosive; |
(f) | resistance of the explosive against influence of water where it is intended to be used in humid or wet conditions and where its safety or reliability may be adversely affected by water; |
(g) | resistance to low and high temperatures, where the explosive is intended to be kept or used at such temperatures and its safety or reliability may be adversely affected by cooling or heating of a component or of the explosive as a whole; |
(h) | the suitability of the explosive for use in hazardous environments (e.g. firedamp atmospheres, hot masses) if it is intended to be used under such conditions; |
(i) | safety features intended to prevent untimely or inadvertent initiation or ignition; |
(j) | the correct loading and functioning of the explosive when used for its intended purpose; |
(k) | suitable instructions and, where necessary, markings in respect of safe handling, storage, use and disposal; |
(l) | the ability of the explosive, its wrapping or other components to withstand deterioration during storage until the ‘use by’ date specified by the manufacturer; |
(m) | specification of all devices and accessories needed for reliable and safe functioning of the explosive. |
2. Each explosive shall be tested under realistic conditions. If this is not possible in a laboratory, the tests shall be carried out in the conditions in which the explosive is to be used.
3. Requirements for the groups of explosives
3.1. | Blasting explosives shall also comply with the following requirements:
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3.2. | Detonating cords, safety fuses, other fuses and shock tubes shall also comply with the following requirements:
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3.3. | Detonators (including delay detonators) and relays shall also comply with the following requirements:
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3.4. | Propellants and rocket propellants shall also comply with the following requirements:
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ANNEX III
CONFORMITY ASSESSMENT PROCEDURES
MODULE B
EU-type examination
1. | EU-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of an explosive and verifies and attests that the technical design of the explosive meets the requirements of this Directive that apply to it. |
2. | EU-type examination shall be carried out as an assessment of the adequacy of the technical design of the explosive through examination of the technical documentation and supporting evidence referred to in point 3, plus examination of a specimen, representative of the production envisaged, of the complete product (combination of production type and design type). |
3. | The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice. The application shall include:
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4. | The notified body shall: For the explosive: |
4.1. | examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the explosive. For the specimen(s): |
4.2. | verify that the specimen(s) have been manufactured in conformity with the technical documentation and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards, as well as the elements which have been designed in accordance with other relevant technical specifications; |
4.3. | carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards, these have been applied correctly; |
4.4. | carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the corresponding essential safety requirements of this Directive; |
4.5. | agree with the manufacturer on a location where the examinations and tests will be carried out. |
5. | The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à-vis the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer. |
6. | Where the type meets the requirements of this Directive that apply to the explosive concerned, the notified body shall issue an EU-type examination certificate to the manufacturer. That certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type. The EU-type examination certificate may have one or more annexes attached. The EU-type examination certificate and its annexes shall contain all relevant information to allow the conformity of manufactured explosives with the examined type to be evaluated and to allow for in-service control. Where the type does not satisfy the applicable requirements of this Directive, the notified body shall refuse to issue an EU-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal. |
7. | The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of this Directive, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly. The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type that may affect the conformity of the explosive with the essential safety requirements of this Directive or the conditions for validity of that certificate. Such modifications shall require additional approval in the form of an addition to the original EU-type examination certificate. |
8. | Each notified body shall inform its notifying authority concerning the EU-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies concerning the EU-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and/or additions thereto which it has issued. The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and/or additions thereto. On request, the Commission and the Member States may 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, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of that certificate. |
9. | The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the explosive has been placed on the market. |
10. | The manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate. |
MODULE C 2
Conformity to type based on internal production control plus supervised product checks at random intervals
1. 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 explosives 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.
2. Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured explosives with the type described in the EU-type examination certificate and with the requirements of this Directive that apply to them.
3. Product checks
A notified body, chosen by the manufacturer, shall carry out product checks or have them carried out at random intervals determined by that body, 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 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 explosive 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 notified body shall take appropriate measures.
The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the explosive performs within acceptable limits, with a view to ensuring conformity of the explosive.
The manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process.
4. CE marking and EU declaration of conformity
4.1. | The manufacturer shall affix the CE marking to each individual explosive that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive. |
4.2. | The manufacturer shall draw up a written EU declaration of conformity for each explosive type and keep it at the disposal of the national authorities for 10 years after the explosive has been placed on the market. The EU declaration of conformity shall identify the explosive type for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. |
5. Authorised representative
The manufacturer’s obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
MODULE D
Conformity to type based on quality assurance of the production process
1. 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 explosives 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.
2. Manufacturing
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the explosives concerned as specified in point 3, and shall be subject to surveillance as specified in point 4.
3. Quality system
3.1. | The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the explosives concerned. The application shall include:
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3.2. | The quality system shall ensure that the explosives are in conformity with the type described in the EU-type examination certificate and comply with the requirements of this Directive that apply to them. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of:
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3.3. | The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard. In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point (e) of point 3.1 to verify the manufacturer’s ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the explosive with those requirements. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision. |
3.4. | The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. |
3.5. | The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. |
4. Surveillance under the responsibility of the notified body
4.1. | The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. |
4.2. | The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:
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4.3. | The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. |
4.4. | In addition, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. |
5. CE marking and EU declaration of conformity
5.1. | The manufacturer shall affix the CE marking, and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual explosive that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive. |
5.2. | The manufacturer shall draw up a written EU declaration of conformity for each explosive type and keep it at the disposal of the national authorities for 10 years after the explosive has been placed on the market. The EU declaration of conformity shall identify the explosive type for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. |
6. The manufacturer shall, for a period ending 10 years after the explosive has been placed on the market, keep at the disposal of the national authorities:
(a) | the documentation referred to in point 3.1; |
(b) | the information relating to the change referred to in point 3.5, as approved; |
(c) | the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4. |
7. Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted.
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.
8. Authorised representative
The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
MODULE E
Conformity to type based on product quality assurance
1. 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 explosives 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.
2. Manufacturing
The manufacturer shall operate an approved quality system for final product inspection and testing of the explosives concerned as specified in point 3 and shall be subject to surveillance as specified in point 4.
3. Quality system
3.1. | The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the explosives concerned. The application shall include:
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3.2. | The quality system shall ensure compliance of the explosives with the type described in the EU-type examination certificate and with the applicable requirements of this Directive. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of:
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3.3. | The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of relevant harmonised standard. In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point (e) of point 3.1, in order to verify the manufacturer’s ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the explosive with those requirements. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision. |
3.4. | The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. |
3.5. | The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. |
4. Surveillance under the responsibility of the notified body
4.1. | The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. |
4.2. | The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:
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4.3. | The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. |
4.4. | In addition, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. |
5. CE marking and EU declaration of conformity
5.1. | The manufacturer shall affix the CE marking, and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual explosive that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive. |
5.2. | The manufacturer shall draw up a written EU declaration of conformity for each explosive type and keep it at the disposal of the national authorities for 10 years after the explosive has been placed on the market. The EU declaration of conformity shall identify the explosive type for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. |
6. The manufacturer shall, for a period ending 10 years after the explosive has been placed on the market, keep at the disposal of the national authorities:
(a) | the documentation referred to in point 3.1; |
(b) | the information relating to the change referred to in point 3.5, as approved; |
(c) | the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4. |
7. Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted.
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.
8. Authorised representative
The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
MODULE F
Conformity to type based on product verification
1. Conformity to type based on product verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 5.1 and 6, and ensures and declares on his sole responsibility that the explosives concerned, which have been subject to the provisions of point 3, are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them.
2. Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured explosives with the approved type described in the EU-type examination certificate and with the requirements of this Directive that apply to them.
3. Verification
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests in order to check the conformity of the explosives with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Directive.
The examinations and tests to check the conformity of the explosives with the appropriate requirements shall be carried out, at the choice of the manufacturer, either by examination and testing of every product as specified in point 4 or by examination and testing of the explosives on a statistical basis as specified in point 5.
4. Verification of conformity by examination and testing of every product
4.1. | All explosives shall be individually examined and appropriate tests set out in the relevant harmonised standard(s) and/or equivalent tests set out in other relevant technical specifications shall be carried out in order to verify conformity with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Directive. In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out. |
4.2. | 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 each approved explosive or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for 10 years after the explosive has been placed on the market. |
5. Statistical verification of conformity
5.1. | The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure the homogeneity of each lot produced, and shall present his explosives for verification in the form of homogeneous lots. |
5.2. | A random sample shall be taken from each lot. All explosives in a sample shall be individually examined and appropriate tests set out in the relevant harmonised standard(s) and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify their conformity with the approved type described in the EU-type examination certificate and with the applicable requirements of this Directive and to determine whether the lot is accepted or rejected. In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out. |
5.3. | If a lot is accepted, all explosives of the lot shall be considered approved, except for those explosives from the sample that have been found not to satisfy the tests. The notified body shall issue a certificate of conformity in respect to the examinations and tests carried out, and shall affix its identification number to each approved explosive 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 explosive has been placed on the market. |
5.4. | If a lot is rejected, the notified body or the competent authority shall take appropriate measures to prevent the placing on the market of that lot. In the event of the frequent rejection of lots the notified body may suspend the statistical verification and take appropriate measures. |
6. CE marking and EU declaration of conformity
6.1. | The manufacturer shall affix the CE marking, and, under the responsibility of the notified body referred to in point 3, the latter’s identification number to each individual explosive that is in conformity with the approved type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive. |
6.2. | The manufacturer shall draw up a written EU declaration of conformity for each explosive type and keep it at the disposal of the national authorities for 10 years after the explosive has been placed on the market. The EU declaration of conformity shall identify the explosive type for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. If the notified body referred to in point 3 agrees and under its responsibility, the manufacturer may also affix the notified body’s identification number to the explosives. If the notified body agrees and under its responsibility, the manufacturer may affix the notified body’s identification number to the explosives during the manufacturing process. |
7. Authorised representative
The manufacturer’s obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the manufacturer’s obligations set out in points 2 and 5.1.
MODULE G
Conformity based on unit verification
1. 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 explosive concerned, which has been subject to the provisions of point 4, is in conformity with the requirements of this Directive that apply to it.
2. Technical documentation
2.1. | 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 explosive’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 explosive. The technical documentation shall, wherever applicable, contain at least the following elements:
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2.2. | The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the explosive has been placed on the market. |
3. Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured explosive with the applicable requirements of this Directive.
4. 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 explosive 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 explosive, 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 explosive has been placed on the market.
5. CE marking and EU declaration of conformity
5.1. | The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 4, the latter’s identification number to each explosive that satisfies the applicable requirements of this Directive. |
5.2. | The manufacturer shall draw up a written EU declaration of conformity and keep it at the disposal of the national authorities for 10 years after the explosive has been placed on the market. The EU declaration of conformity shall identify the explosive for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. |
6. Authorised representative
The manufacturer’s obligations set out in points 2.2 and 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
ANNEX IV
EU DECLARATION OF CONFORMITY (No XXXX) (1)
1. | No … (product, type, batch or serial number): |
2. | Name and address of the manufacturer and, where applicable, his authorised representative: |
3. | This declaration of conformity is issued under the sole responsibility of the manufacturer. |
4. | Object of the declaration (identification of product allowing traceability): |
5. | The object of the declaration described above is in conformity with the relevant Union harmonisation legislation: |
6. | References to the relevant harmonised standards used or references to the other technical specifications in relation to which conformity is declared: |
7. | The notified body … (name, number) performed … (description of intervention) and issued the certificate: |
8. | Additional information: Signed for and on behalf of: (place and date of issue): (name, function) (signature): |
(1) It is optional for the manufacturer to assign a number to the declaration of conformity.
ANNEX V
PART A
Repealed Directives with list of the successive amendments thereto
(referred to in Article 53)
Council Directive 93/15/EEC (OJ L 121, 15.5.1993, p. 20). | |
Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). | Only point (13) of Annex II |
Regulation (EC) No 219/2009 of the European Parliament and of the Council (OJ L 87, 31.3.2009, p. 109). | Only point 2.2 of the Annex |
Regulation (EU) No 1025/2012 of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12). | Only point (b) of Article 26(1) |
Commission Directive 2004/57/EC (OJ L 127, 29.4.2004, p. 73). |
PART B
Time-limits for transposition into national law and dates of application
(referred to in Article 53)
Directive | Time-limit for transposition | Date of application |
93/15/EEC (Articles 9, 10, 11, 12, 13 and 14) | 30 September 1993 | 30 September 1993 |
93/15/EEC (all other articles) | 30 June 1994 | 1 January 1995 |
2004/57/EC | 31 December 2004 | 31 January 2005 |
ANNEX VI
CORRELATION TABLE
Directive 93/15/EEC | Directive 2004/57/EC | This Directive |
Article 1(1) | Article 1(1) | |
Article 1(2) | Article 2(1) | |
Article 1(3) | Article 1(2) | |
Article 1(4) | Article 2(3) to (6), (8), (13) and (14) | |
— | Article 2(2), (7), (9) to (12) and (15) to (24) | |
Article 1(5) | Article 1(3) | |
Article 2(1) | Article 3 | |
Article 2(2) | Article 4 | |
Article 2(3) | Article 22 | |
Article 3 | Article 4 and Article 5(1) | |
— | Article 5(2) to (8) | |
— | Article 6 | |
— | Article 7 | |
— | Article 8 | |
— | Article 9 | |
Article 10 | ||
Article 4(1) | Article 19 | |
Article 4(2) | — | |
Article 5 | Article 43(3) | |
Article 6(1) | Article 20 | |
— | Article 21 | |
— | Articles 24 to 27 | |
Article 6(2) | Articles 28 to 40 | |
Article 7(1) | Articles 22 and 23 | |
Article 7(2) | Article 22 | |
Article 7(3) | Article 22 | |
— | Article 41 | |
Article 8(1) | Articles 42 and 44 | |
Article 8(2) | Article 43 | |
Article 8(3) | Article 45 | |
Article 9(1) | Article 11(1) | |
Article 9(2) | — | |
Article 9(3) | Article 11(2) | |
Article 9(4) | Article 11(3) | |
Article 9(5) | Article 11(4) | |
Article 9(6) | Article 11(6) | |
Article 9(7) | Article 11(5) | |
Article 9(8) | Article 11(7) | |
Article 9(9) | Article 11(8) | |
Article 10(1) | Article 12(1) | |
Article 10(2) | Article 12(2) | |
Article 10(3) | Article 12(3) | |
Article 10(4) | Article 12(4) | |
Article 10(5) | Article 12(5) | |
Article 11 | Article 13 | |
Article 12(1) | Article 14(1) | |
Article 12(2) | Article 14(2) | |
Article 13(1) | Article 49(1) | |
Article 13(2) | — | |
Article 13(3) | Articles 46 and 47 | |
— | Article 48 | |
Article 13(4) | Article 49(2) to (5) | |
Article 13(5) | Articles 46 and 47 | |
Article 14, first paragraph | Article 16 | |
Article 14, second paragraph | Article 15(1) and (4) | |
Article 14, third paragraph | Article 15(2) and (4) | |
Article 14, fourth paragraph | Article 15(3) | |
Article 15 | — | |
Article 16 | Article 17 | |
Article 17 | Article 50 | |
Article 18 | Article 18 | |
Article 19 | Articles 51 and 52 | |
— | Article 53 | |
— | Article 54 | |
Article 20 | Article 55 | |
Article 1 | — | |
Article 2 | — | |
Article 3 | — | |
Article 4 | — | |
Article 5 | — | |
Annex I | Annex I | |
Annex II | — | |
Annex I | Annex II | |
Annex II | Annex III | |
Annex III | Article 28 | |
Annex IV | Article 22 | |
— | Annex IV | |
— | Annex V | |
— | Annex VI |
STATEMENT OF THE EUROPEAN PARLIAMENT
The European Parliament considers that only when and in so far as implementing acts in the sense of Regulation (EU) No 182/2011 are discussed in meetings of committees, can the latter be considered as ‘comitology committees’ within the meaning of Annex I to the Framework Agreement on the relations between the European Parliament and the European Commission. Meetings of committees thus fall within the scope of point 15 of the Framework Agreement when and insofar as other issues are discussed.