REGULATIONS, 2004

L.N. 279 of 2004

EXPLOSIVES ORDINANCE

(CAP. 33)

CIVIL EXPLOSIVES

REGULATIONS, 2004

IN exercise of the powers conferred by article 22 of the Explosives

Ordinance, the Minister for Justice and Home Affairs, has made the

following regulations:-

(1) The title of these regulations is the Civil Explosives

Regulations, 2004.

(2) These regulations shall come into force on the 1 st June,

2004.

(1) These regulations shall apply to explosives as defined in

regulation 3 of these regulations.

(2)

The following are excluded from the scope of these

regulations

(a) explosives, including ammunition, intended for use, in

accordance with Maltese law, by the armed forces or police;

(b) pyrotechnical articles;

(c) ammunition, except as provided in regulation 10 of these

regulations.

For the purposes of these regulations, the following definitions

shall apply

“approval” shall mean the decision taken to allow envisaged

transfers of explosives;

“dealer” shall mean any natural or legal person whose

occupation consists wholly or partly in the manufacture, trade,

exchange, hiring out, repair or conversion of fire arms and

ammunition;

“explosives” shall mean the materials and articles considered

to be such in the United Nations recommendations on the transport

of dangerous goods and falling within Class 1 of those

recommendations;

“placing on the market” shall mean any first disposal against

payment or free of charge of explosives covered by these

regulations with a view to their distribution and, or, use;

“safety” shall mean the prevention of accidents and, where

prevention fails, the containment of their effects;

“security” shall mean the prevention of use contrary to law

and order;

“the Ordinance” means the Explosives Ordinance;

“transfer” shall mean any physical movement of explosives

apart from movements within one and the same site;

“undertaking in the explosives sector” shall mean any natural

or legal person possessing a licence or authorization which entitles

him to engage in the manufacture, storage, use, transfer or trade in

explosives;

“United Nations recommendations” shall mean the

recommendations laid down by the United Nations of Experts on

the transport of Dangerous Goods, as published in the UN (Orange

Book) and as amended by the date when these regulations are

adopted.

(1) Explosives falling within the scope of these regulations Presumptions of

must comply with the essential safety requirements set out in Schedule conformity.

I which apply to them.

(2) Explosives falling within the scope of these regulations

which comply with the relevant national standards transposing the

harmonized standards the references of which have been published in

the Official Journal of the European Communities shall be considered

to be in conformity with the essential safety requirements referred to in

sub-regulation (1) hereof. The references of the national standards

transposing those harmonized standards shall be published in the

Gazette.

(1) Updated information concerning undertakings in the General

requirements.

explosives sector possessing licences or authorizations shall be kept by

the Commissioner of Police.

(2) The undertakings referred to in sub-regulation 1 of this

regulation must possess a system for keeping track of explosives such

that those holding explosives can be identified at any time. Undertakings

in the explosives sector shall keep such records of their transitions as

are necessary to fulfil the obligations of this regulation.

(3) The documents referred to in sub-regulation 2 of this

regulation must be kept for at least three years after the end of the

calendar year in which the recorded transaction took place, even if the

undertaking has ceased trading. They must be immediately available

for inspection at the request of the Commissioner of Police or the

committee referred to in article 23 of the Ordinance.

(4) All explosives must be properly marked.

(5) In issuing a licence or authorization for the purpose of

allowing an explosives manufacturing activity to be exercised, the

Commissioner of Police shall check in particular that the persons

responsible are capable of complying with the technical commitments

they assume.

(1) The procedures for the attestation of the conformity of

explosives shall be either: (a) EC type examination (Module B) referred

to in Schedule II (1), and, at the choice of the manufacturer, either: (i)

the type conformity (Module C) referred to in Schedule II (2), or(ii) the

production quality assurance procedure (Module D) referred to in

Schedule II (3), or(iii) the product quality assurance procedure (Module

E) referred to in Scehdule II (4), or (iv) the product verification (Module

F) referred to in Schedule II (5); or(b) the unit verification (Module G)

referred to in Schedule II (6).

(1) Explosives falling within the scope of these regulations

may be placed on the market only if they comply with all the provisions

thereof, are provided with the CE marking and their conformity has

been assessed in accordance with the procedures referred to in Schedule

II.

(2) Where explosives falling within the scope of these

regulations are subject to other regulations which cover other aspects

and prescribe the fixing of the CE marking, this marking shall indicate

that the abovementioned products are also presumed to conform to the

provisions of any regulations which apply to them.

(3) The CE marking of conformity shall be affixed in such

a way as to be visible, easily legible and indelible on the explosives

themselves or, if this is not possible, on an identification plate attached

thereto or, in the last resort, if the first two methods cannot be used, on

the packaging. The identification plate must be so designed as to make

its reuse impossible. The model to be used for the CE marking shall be

that reproduced in Schedule IV.

(4) It shall be prohibited to affix on explosives any mark or

inscription which may confuse third persons as to the meaning and

style of writing of the CE marking. Any other mark may be affixed on

explosives provided the visiblility and legibility of the CE marking is

not impaired.

(5) Without prejudice to the provisions of sub-regulation

(2) of this regulation, where it is established that the CE marking has

been unduly affixed, the manufacturer, his agent or, failing these, the

person responsible for placing the product in question on the market

shall be obliged to restore the product to conformity with regard to the

provisions on marking and end the infringement, without prejudice to

any other measures which may be taken by the Commissioner of Police

in accordance with the Ordinance.

(6) Where non-compliance to the provisions persists, the

Commissioner of Police shall take all appropriate measures to restrict

or prohibit the placing on the market of the product in question or to

ensure that it is withdrawn from the market in accordance with the

procedures laid down in regulation 8.

(1) (2) Where it is established that an explosive bearing Withdrawal and

CE conformity marking and being used for its intended purpose may prohibition

market.

compromise safety, the Commissioner of Police shall take all interim

measures that are necessary to withdraw the explosive from the market

or prohibit its being placed on the market or its freedom of

movement.Any measures taken pursuant to sub-regulation (1) shall be

communicated to both the Consumer and Industrial Goods Directorate

and the Foodstuffs, Chemicals and Cosmetics Directorate of the Malta

Standards Authority.

(1) Explosives covered by these regulations may be Provisions

transferred between Malta and Member States of the European governing

supervision of

Community only in accordance with the following provisions :-

transfers of

explosives.

(a) In the case of transfers of explosives from a Member

State of the European Community to Malta, approval to transfer

such explosives shall be obtained by the consignee from the

Commissioner of Police. The Commissioner of Police shall verify

that the consignee is legally authorized to acquire explosives and

that he is in possession of the necessary licences or authorizations.

(b) (c) Where the Commissioner of Police approves a

transfer from a Member State of the European Community to Malta,

he shall issue to the consignee a document which includes all the

information referred to in paragraph (d) of this sub-regulation. Such

a document must accompany the explosives until they arrive at

their stated destination. It must be produced at the request of any

relevant competent authorities. A copy of this document shall be

retained by the consignee who shall present it for examination by

the Commissioner of Police, at the latter’s request.Without

prejudice to the provisions of paragraph (d) of this sub-regulation,

paragraphs (a) and (b) thereof shall also apply to transfers of

explosives within Malta.

(d) Where the Commissioner of Police considers that special

security requirements such as those referred to in paragraph (b)

hereof are unnecessary, explosives can be transferred within Malta

on their territory or part thereof without prior provision of

information within the meaning of paragraph (e) hereof. The

Commissioner of Police shall then grant an approval for a fixed

period and liable to suspension or withdrawal at any time on the

basis of a reasoned justification. The document referred to in

paragraph (b) hereof which must accompany the explosives until

they arrive at their destination, shall refer solely to the

abovementioned approval.

(e)(i)(ii)(iii)(iv)(v)(vi)(vii) Where transfers of explosives

must be specially supervised in order to comply with special

security requirements, prior to the transfer the following

information shall be provided by the consignee to the

Commissioner of Police: the names and addresses of the operators

concerned; this information must be detailed enough to enable the

operators to be contacted and confirmation to be obtained that the

persons in question are legally entitled to receive the consignment,

the number and quantity of the explosives being transferred, a full

description of the explosive in question and of the means of

identification, including the United Nations identification

number,where the explosives are to be placed on the market,

information on compliance with conditions for placing on the

market,the means of transfer and the itinerary, the expected dates

of departure and arrrival, where necessary, the precise points of

entry to and exit from Malta and/or any Member States of the

European Community.The Commissioner of Police shall examine

the conditions under which the transfer may take place, with

particular regard to the special security requirements. If the special

security requirements are satisfied, approval for the transfer shall

be granted. In the event of transit through the territory of other

States forming part of the European Community, the consignee

must obtain the necessary auhorizations for the transfer through

those States in accordance with the provisions of paragraphs (a) to

(d) hereof.

(f) No supplier may transfer explosives to a consignee within

Malta or the European Community unless the consignee has

obtained the necessary auhorizations for the transfer in accordance

with the provisions of paragraphs (a) to (d) hereof.

(2) The provisions of sub-regulation (1) shall also apply to

the transfer of explosives from third countries to Malta. In such

cases, the consignee must also be in possession of a valid

importation licence issued by the Department of Trade.

(1) Ammunition may be transferred within Malta and Transfer of

Ammunition

between Malta and Member States of the European Community only in

accordance with the procedure laid down in the following regulations.

These provisions shall also apply to transfers under mail-order sales

(a)(i)(ii)(iii)(iv)(v)(vi) Where ammunition is to be

transferred from Malta to a consignee in Malta or a Member State

of the European Community, the person concerned shall, before

any dispatch, communicate to the Commissioner of Police:the

names and addresses of the person selling or transferring the

ammunition, of the person purchasing or acquiring the ammunition

and, where appropriate, of the owner,the address to which the

ammunition is to be consigned or transported, the quantity of

ammunition to be consigned or transported, data making it possible

to identify the ammunition and also an indication that the

ammunition has undergone a check in accordance with the

Convention of 1 st July 1969 on the Reciprocal Recognition of

Proofmarks on Small Arms, the means of transfer, the date of

departure and the estimated date of arrival. The information referred

to in sub-paragraphs (v) and (vi) need not be supplied in the event

of a transfer between dealers. The Commissioner of Police shall

examine the conditions under which the transfer is to be carried

out, in particular with regard to security. When such a transfer is

authorized the Commissioner of Police shall issue a licence

incorporating all the particulars referred to in sub-paragraph (i).

That licence shall accompany the ammunition until it reaches its

destination; it shall be produced whenever so required by the

competent authorities of that country.

(b) Dealers may be granted the right to effect transfers of

ammunition from Malta to a dealer established in a Member State

of the European Community without the prior authorization referred

to in paragraph (1)(a) of this regulation. To that end the

Commissioner of Police may issue an authorization valid for three

years which may at any time be suspended or cancelled by reasoned

decision. A document referring to that authorization must

accompany the ammunition until it reaches its destination. It must

be produced whenever so required by the relevant competent

authorities. Before effecting the transfer, the dealer shall

communicate to the Commissioner of Police all the particulars listed

in sub-paragraph (1)(a)(i) of this regulation.

(2) The provisions of sub-regulation (1) shall also apply to the

transfer of ammunition from third countries to Malta. In such cases, the

consignee must also be in possession of a valid importation licence

issued by the Department of Trade.

(3) By derogation from sub-regulation 9(1) paragraphs (b) to (e)

and regulations 9(2), 10(1) and 10(2), the Commissioner of Police may,

in case of grave threats to, or attacks upon, public security through the

illicit possession or use of explosives covered by these regulations, take

all necessary measures concerning transfers of explosives or ammunition

in order to prevent such illicit possession or use. These measures shall

respect the principle of proportionality. They must constitute neither a

means of arbitrary discrimination nor a veiled restriction in trade between

countries.

Explosives, as defined by these regulations, and with the

exception of the exclusions mentioned in regulation 2(2), shall fall within

the scope of the duties of the Director of Market Surveillance, as defined

in article 27 of the Product Safety Act, 2001.

B

Schedule I

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 including until such time

as 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 minimizes

effects on the environment.

II.

Special requirements.

1. As a minimum, the following information and properties - where appropriate

- must be considered. Each explosive should be tested under realistic conditions. If

this is not possible in a laboratory, the tests should be carried out in the conditions in

which the explosive is to be used.

(a) Construction and characteristic properties, including chemical

composition, degree of blending 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.

environment endangered by firedamp, hot masses, etc.) 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 in Maltese and/or English.

(l) The ability of the explosive, its covering 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. The various groups of explosives must at least also comply with the following

requirements

Blasting explosives

(a) The proposed method of initiation must ensure safe, reliable and

complete detonation or deflagration as appropriate, of the blasting explosive. In

the particular case of black powder, it is the capacity as regards deflagration which

shall be checked.

(b) Blasting explosives in cartridge form must transmit the detonation safely

and reliably from one end of the train of cartridges to the other.

(c) The gases produced by blasting explosives intended for underground

use may contain carbon monoxide, nitrous gases, other gases, vapours or airborn

solid residues only in quantities which do not impair health under normal operating

conditions.

Detonating cords, safety fuses, igniter cords and shock tubes

(a) The covering of detonating cords, safety fuses and igniter cords must

be of adequate mechanical strength and adequately protect the explosive filling

when exposed to normal mechanical stress.

B

(b) The parameters for the burning times of safety fuses must be indicated

and must be reliably met.

(c) Detonating cords must be capable of being reliably initiated, be of

sufficient initiation capability and comply with requirements as regards storage

even in particular climatic conditions.

Detonators (including delay detonators) and relays

(a) Detonators must reliably initiate the detonation of the blasting

explosives which are intended to be used with them under all foreseeable conditions

of use.

(b)

Relays must be capable of being reliably initiated.

(c)

The initiation capability must not be adversely affected by humidity.

(d) The delay times of delay detonators must be sufficiently uniform to

ensure that the probability of overlapping of the delay times of adjacent time

steps is insignificant.

(e) The electrical characteristics of electric detonators must be indicated

on the packaging (e.g. no-fire current, resistance, etc.).

(f) The wires of electric detonators must be of sufficient insulation and

mechanical strength including the solidity of the link to the detonator, taking

account of their intended use.

Propellants and rocket propellants

(a)

These materials must not detonate when used for their intended purpose.

(b) Propellants where necessary (e.g. those based on nitrocellulose) must

be stabilized against decomposition.

(c) Solid rocket propellants, when in compressed or cast form, must not

contain any unintentional fissures or gas bubbles which dangerously affect their

functioning.

Schedule II

1. MODULE B: EC type-examination

1. This module describes that part of the procedure by which a notified body

ascertains and attests that an example, representative of the production envisaged, meets

the relevant provisions of the Regulations.

2. The application for EC type-examination is lodged by the manufacturer or

his authorized representative with a notified body of his choice.

The application must include

- the name and address of the manufacturer and, if the application is lodged

by the authorized representative, the name and address in addition,

- a written declaration that the same application has not been lodged with

any other notified body,

- the technical documents, as described in Section 3.

The applicant must place at the disposal of the notified body an example

representative of the production envisaged, hereinafter called ‘type’. The notified body

may request further examples if needed for carrying out the test programme.

3. The technical documents must enable the conformity of the appliance with

the requirements of the Regulations to be assessed. They must, as far as is relevant for

such assessment, cover the design, manufacture and operation of the appliance and

contain as far as is relevant for assessment

- a general type-description,

- conceptual design and manufacturing drawings and diagrams of

components, sub-assemblies, circuits, etc.,

- descriptions and explanations necessary for the understanding of the

drawings and diagrams and the operation of the product,

- a list of the standards referred to in regulation 4(2) of these regulations,

applied in full or in part, and descriptions of the of the solutions adopted to meet

the essential requirementsof these Regulations,

- results of design calculations made, examinations carried out, etc.,

- test reports.

4. The notified body must

4.1. examine the technical documents, verify that the type has been manufactured

in conformity with those documents and identify the elements which have been designed

in accordance with the relevant provisions of the standards referred to in regulation

4(2) of these regulations as well as the components which have been designed without

applying the relevant provisions of those standards;

B

4.2. perform or have performed the appropriate examinations and necessary

tests to check whether, where the standards referred to in regulation 4(2) of these

regulations have not been applied, the solutions adopted by the manufacturer meet the

essential requirements of the regulations;

4.3. perform or have performed the appropriate examinations and necessary

tests to check whether, where the manufacturer has chosen to apply the relevant

standards, these have actually been applied;

4.4. agree with the applicant the location where the examinations and necessary

tests are to be carried out.

5. Where the type meets the relevant provisions of these regulations, the notified

body issues an EC type-examination certificate to the applicant. The certificate contains

the name and addres of the manufacturer, the conclusion of the examination and

necessary data for identification of the approved type.

A list of the relevant parts of the technical documents is annexed to the certificate

and a copy kept by the notified body.

If the manufacturer or his authorized representative is refused a type certificate,

the notified body must provide detailed reasons for such refusal.

Provision must be made for an appeals procedure.

6. The applicant informs the notified body that holds the technical documents

concerning the EC type-examination certificate of all modidfications to the approved

appliance which must receive additional approval where such changes may affect the

conformity with the essential requirements or the prescribed conditions for use of the

product. This additional approval is given in the form of an addition to the original EC

type-examination certificate.

7. Each notified body must communicate to the other notified bodies the relevant

information concerning the EC type-examination certificates and additions issued and

withdrawn.

8. The other notified bodies may receive copies of the EC type-examination

certificates and/or their additions. The Annexes to the certificates must be kept at the

disposal of the other notified bodies.

9. The manufacturer or his authorized representative must keep with the technical

documents copies of EC type-examination certificates and their additions for a period

of at least 10 years after the last date of manufacture of the product concerned.

2. MODULE C: Conformity to type

1. This module describes that part of the procedure whereby the manufacturer

or his authorized representative ensures and declares that the explosives concerned

are in conformity with the type as described in the EC type-examination certificate

and satisfy the requirements of these Regulations that apply to them. The manufacturer

must affix the CE mark to each explosive and draw up a written declaration of

conformity.

2. The manufacturer must take all measures necessary to ensure that the

manufacturing process assures the conformity of the manufactured product with the

type as described in the EC type-examination certificate with the essential safety

requirements of the regulations.

3. The manufacturer or his authorized representative must keep a copy of the

declaration of conformity for a period of at least 10 years after the last date of

manufacture of the product concerned.

4. A notified body chosen by the manufacturer must perform or have performed

examinations of the product at random intervals. A suitable sample of the finished

products, taken on the spot by the notified body, is examined and appropriate test,

defined in the applicable standard or standards referred to in regulation 4(2) of these

regulations or equivalent tests are carried out to check the conformity of the product

with the requirements of the corresponding regulations. In the event of one or more

samples of the products examined not conforming, the notified body must take the

appropriate measures.

Under the responsibility of the notified body the manufacturer shall affix the

identification symbol of that body during the manufacturing process.

3. MODULE D: Production quality assurance

1. This module describes the procedure whereby the manufacturer who satisfies

the obligations of Section 2 ensures and declares that the explosives concerned are in

conformity with the type as described in the EC type-examination certificate and satisfy

the requirements of these regulations. The manufacturer affixes the CE mark to each

explosive and draws up a written declaration of conformity. The CE mark is

accompanied by the identification symbol of the notified body responsible for the

checks referred to in Section 4.

2. The manufacturer must operate an approved quality system for production,

final product inspection and testing as specified in Section 3. He is subject to the

checks referred to in Section 4.

3. Quality system

B

3.1. The manufacturer lodges an application for assessment of his quality system

with a notified body of his choice, for the explosives concerned.

The application must include

- all relevant information for the explosive category envisaged,

- the documents concerning the quality system,

- the technical documents pertaining to the approved type and a copy of the

EC type

-examination certificate.

3.2. The quality system must ensure conformity of explosives with the type as

described in the EC type-examination certificate and with the requirements of these

regulations that apply to them.

All the elements, requirements and provisions adopted by the manufacturer must

be documented in a systematic and orderly manner in the form of written policies,

procedures and instructions. The quality system documents must permit a consistent

interpretation of the quality programmes, plans, manuals and quality records.

It must contain in particular an adequate description of

- the quality objectives and the organizational structure, responsibilities and

powers of the management with regard to the quality of the explosives,

- the manufacturing, quality control and quality assurance techniques,

processes and systematic actions that will be used,

- the examinations and tests that will be carried out before, during and after

manufacture, and the frequency with which they will be carried out,

- the quality records, such as inspection reports and test data, calibration

data, qualification reports of the personnel concerned, etc.,

- the means of monitoring the achievement of the required quality of explosive

and the effective operation of the quality system.

3.3. The notified body must assess the quality system to determine whether it

satisfies the requirements referred to in 3.2. It must presume conformity with those

requirements in respect of quality systems that implement the relevant harmonized

standard. The auditing team must have at least one member with experience of assessing

the relevant product technology. The assessment procedure includes an inspection visit

to the manufacturer’s premises.

The decision is notified to the manufacturer. The notification must contain the

conlusions of the examination and the duly substantiated assessment decision.

3.4. The manufacturer must undertake to fulfil the obligations arising out of

the quality system as approved and maintain it at an adequate and efficient level.

The manufacturer or his authorized representative must keep the notified body

that has approved the quality system informed of any proposed change in the quality

system.

The notified body must assess the changes proposed and decide whether the altered

quality system will still satisfy the requirements referred to in 3.2 or whether

reassessment is required.

It must notify the manufacturer of its decision. The notification must contain the

conclusions of the examination and the substantiated assessment decision.

4. Monitoring under the responsibility of the notified body

4.1 The purpose of monitoring is to make sure that the manufacturer duly fulfils

the obligations arising out of the approved quality system.

4.2 The manufacturer must allow the notified body access for inspection

purposes to the manufacturing, inspection, testing and storage premises and provide it

with all necessary information, in particular

- the quality system documents,

- the quality records, such as inspection reports and test data, calibration

data, qualification reports of the personnel concerned, etc.

4.3. The notified body must periodically carry out audits to make sure that the

manufacturer maintains and applies the quality system and provides an audit report to

the manufacturer.

4.4. Additionally the notified body may pay unannounced visits to the

manufacturer. During such visits the notified body may carry out tests or have them

carried out to verify that the quality system is functioning correctly; if necessary, the

notified body must provide the manufacturer with a visit report and, if a test has taken

place, with a test report.

5. The manufacturer must, for a period of at least 10 years after the last date of

manufacture of the product, keep at the disposal of the national authorities

- the document referred to in the second indent of 3.1,

B

- the updating referred to in second paragraph of 3.4,

- the decisions and reports form the notified body which are referred to in

the final paragraph of 3.4, and in 4.3 and 4.4.

6. Each notified body must give the other notified bodies the relevant information

concerning the quality system approvals issued and withdrawn.

4. MODULE E: Product quality assurance

1. This module describes the procedure whereby the manufacturer who satisfies

the obligations of Section 2 ensures and declares that the explosives are in conformity

with the type as described in the EC type-examination certificate. The manufacturer

must affix the CE mark to each explosive and draw up a written declaration of

conformity. The CE mark must be accompanied by the identification symbol of the

notified body responsible for the checks referred to in Section 4.

2. The manufacturer must operate an approved quality system for final explosive

inspection and testing as specified in Section 3. He must be subject to the checks

referred to in Section 4.

3. Quality system

3.1. The manufacturer lodges an application with a notified body of his choice

for the assessment of the quality system for his explosives.

The application must include

- all relevant information for the explosive category envisaged,

- the quality system’s documentation,

- the technical documents pertaining to the approved type and a copy of the

EC type-examination certificate.

3.2. Under the quality system, each explosive is examined and appropriate tests

as defined in the relevant standard(s) referred to in regulation 4(2) of these regulations

or equivalent tests are carried out in order to verify its conformity with the relevant

requirements of the regulations. All the elements, requirements and provisions adopted

by the manufacturer must be documented in a systematic and orderly manner in the

form of written policies, procedures and instructions. This quality system documentation

must enable the quality programmes, plans, manuals and records to be interpreted in a

uniform manner.

It must in particular contain an adequate description of

- the quality objectives and the organizational structure, responsilities and

powers of the management with regard to product quality,

- the examination and tests that will be carried out after manufacture,

- the means of monitoring the effective operation of the quality system,

- quality records, such as inspection reports and test data, calibration data,

qualification reports of the personnel concerned, etc.

3.3. The notified body must assess the quality system to determine whether it

satisfies the requirements referred to in 3.2. It must presume conformity with these

requirements in respect of quality systems that implement the relevant harmonized

standard.

The auditing team must have at least one member with experience of assessing

the relevant product technology. The assessment procedure must include an inspection

visit to the manufacturer’s premises.

The manufacturer must be notified of the decision. The notification must contain

the conclusions of the examination and the substantiated assessment decision.

3.4. The manufacturer must undertake to fulfil the obligations arising out of

the quality system as approved and maintain it at an adequate and efficient level.

The manufacturer or his authorized representative must keep the notified body

which has approved the quality system informed of any proposed change in the quality

system.

The notified body must assess the changes proposed and decide whether the altered

quality system will still satisfy the requirements referred to in 3.2 or whether a

reassessment is required.

It must notify the manufacturer of its decision. The notification must contain the

conclusions of the examination and the substantiated assessment decision.

4.1. The purpose of monitoring is to make sure that the manufacturer duly

fulfils the obligations arising out of the approved quality system.

4.2. The manufacturer must allow the notified body access for inspection

purposes to the inspection, testing and storage premises and provide it with all necessary

information, in particular

- the quality system documentation,

B

- the technical documents,

- the quality records, such as inspection reports and test data, calibration

data, qualification reports of the personnel concerned, etc.

4.3. The notified body must periodically carry out audits to ensure that the

manufacturer maintains and applies the quality system and must provide an audit

report to the manufacturer.

4.4. Additionally, the notified body may pay unannounced visits to the

manufacturer. During such visits the notified body may carry out tests or have them

carried out to verify that the quality system is functioning correctly; if necessary, the

notified body must provide the manufacturer with a visit report and, if a test has been

carried out, with a test reports.

5. The manufacturer must for a period of at least 10 years after the last date of

manufacture of the product keep at the disposal of the national authorities

- the documents referred to in the second indent of 3.1,

- the changes referred to in the second paragraph of 3.4,

- the decisions and reports form the notified body which are referred to in

the final paragraph of 3.4, and in 4.3 and 4.4.

6. Each notified body must forward to the other notified bodies the relevant

information concerning the quality system approvals issued and withdrawn.

5. MODULE F: Product verification

1. This module describes the procedure whereby a manufacturer or his

authorized representative checks and attests that the explosives subject to the provisions

of 3 are in conformity with the type as described in the EC type-examination certificate

and satisfy the relevant requirements of the Regulations.

2. The manufacturer shall take all measures necessary in order that the

manufacturing process ensures conformity of the explosives with the type as described

in the EC type-examination certificate and with the requirements of the regulations

that apply to them. He shall affix the CE mark to each explosive and shall draw up a

declaration of conformity.

3. The notified body shall carry out the appropriate examinations and tests in

order to check the conformity of the explosive with the relevant requirements of the

regulations by examination and testing of every explosive as specified in 4.

The manufacturer or his authorized representative shall keep a copy of the

declaration of conformity for a period ending at least 10 years after the last explosive

has been manufactured.

4. Verification by examination and testing of every explosive

4.1. All explosives shall be individually examined and appropriate tests as set

out in the relevant standard(s) referred to in regulation 4(2) of these regulations or

equivalent tests shall be carried out in order to verify their conformity with the relevant

type and requirements of the regulations.

4.2. The notified body shall affix or cause to be affixed, its identification symbol

to each approved explosive and draw up a written certificate of conformity relating to

the tests carried out.

4.3. The manufacturer or his authorized representative shall ensure that he is

able to supply the notified body’s certificates of conformity on request.

6. MODULE G: Unit verification

1. This module describes the procedure whereby the manufacturer ensures and

declares that the explosive which has been issued with the certificate referred to in

Section 2 conforms to the relevant requirements of the Regulations. The manufacturer

must affix the CE mark to the explosive and draw up a declaration of conformity.

2. The notified body must examine the explosive and carry out the appropriate

tests as set out in the relevant standard(s) referred to in regulation 4(2) of these

regulations, or equivalent tests, to ensure its conformity with the relevant requirements

of the regulations.

The notified body must affix, or cuase to be affixed, its identification symbol on

the approved explosive and draw up a certificate of conformity concerning the tests

carried out.

3. The aim of the technical documents is to enable conformity with the

requirements of the regulations to be assessed and the design, manufacture and operation

of the explosive to be understood.

The documents must contain, in so far as is necessary for the assessment

- a general description of the type,

- conceptual design and manufacturing drawings and schemes of components,

sub-assemblies, circuits, etc.,

B

- descriptions and explanations necessary for the understanding of the said

drawings and schemes and the operation of the explosive or protection system,

- a list of the standards referred to in regulation 4(2) of these regulations,

applied in full or in part, and descriptions of the solutions adopted to meet the

essential requirements of the regulations where the standards referred to in

regulation 4(2) of these regulations have not been applied,

- results of design calculations made, examinations carried out, etc.,

- test reports.

Schedule III

MINIMUM CRITERIA TO BE TAKEN INTO ACCOUNT BY MEMBER STATES

FOR THE NOTIFICATION OF BODIES

1. The body, its director and the staff responsible for carrying out the verification

tests shall not be the designer, manufacturer, supplier or installer of explosives which

they inspect, nor the authorized representative of any of these parties. They shall not

become either involved directly or as authorized representatives in the design,

construction, markteting or maintenance of such explosives. This does not preclude

the possibility of exchanges of technical information between the manufacturer and

the body.

2. The body and its staff shall carry out the verification tests with the highest

degree of professional integrity and technical competence and shall be free from all

pressures and inducements, paritcularly financial, which might influence thier judgement

or the results of the inspection, especially from persons or groups of persons with an

interest in the result of verifications.

3. The body shall have at is disposal the necessary staff and possess the necessary

facilities to enable it to perform properly the administrative and technical tasks connected

with verification; it shall also have access to the equipment required for special

verification.

4. The staff responsible for inspection shall have

- sound technical and professional training,

- satisfactory knowledge of the requirments of the tests they carry out and

andequate experience of such tests,

- the ability to draw up the certificates, records and reports required to

authenticate the performance of the tests.

5. The impartiality of inspection staff shall be guaranteed. Their remuneration

shall not depend on the number of tests carried out or on the results of such tests.

6. The body shall take out civil liability insurance unless its liability is assumend

by the State in accordance with national law, or the State itself is directly responsible

for the tests.

7. The staff of the body shall be bound to observe professional secrecy with

regard to all information gained in carrying out its tasks (except vis-·-vis) the competent

administrative authorities of the State in which its activities are carried out) under

these regulations or any provision of national law giving effect to it.

B

Schedule IV

CONFORMITY MARKING The CE conformity marking shall consist of the

initials ‘CE’ taking the following form

If the marking is reduced or enlarged the proportions given in the above graduated

drawing must be respected.

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press