Regulations, 2016

L.N. 241 of 2016

EXPLOSIVES ORDINANCE

(CAP. 33)

PRODUCT SAFETY ACT

(CAP. 427)

Making Available on the Market of Explosives for Civil Uses

Regulations, 2016

IN exercise of the powers conferred by articles 38 and 39 of the

Product Safety Act, the Minister for Social Dialogue, Consumer

Affairs and Civil Liberties, on the advice of the Malta Competition

and Consumer Affairs Authority, has made the following

regulations:-

(1) The title of these regulations is Making Available on Title and scope.

the Market of Explosives for Civil Uses Regulations, 2016.

(2) These regulations transpose Directive 2014/28/EU of the

European Parliament and of the Council of 26 February 2014 on the

harmonisation of the laws of the Member States relating to the

making available on the market and supervision of explosives for

civil uses (recast).

(3) These regulations lay down requirements relating to the

safety and making available on the market of civil explosives and

rules on their free movement in the European Union.

The making available on the market of explosives covered Conformity

by the Civil Explosives Regulations which are in conformity with S.L. 33.04.

those regulations and which were placed on the market before 20

April 2016 shall not be impeded.

(1)

These regulations shall apply to explosives for civil Applicability.

uses.

(2) These regulations shall not apply to

(a)

explosives, including ammunition, intended for use,

in accordance with Maltese law, by the armed forces or the

police;

(b) pyrotechnic articles falling within the scope of the

Making Available on the Market of Pyrotechnic Articles S.L. 427.70

Regulations;

(c)

ammunition, save as provided for in regulations 24

and 25.

(3) Schedule I contains a non-exhaustive list of pyrotechnic

articles referred to in regulation 3(2)(b) and of ammunition as defined

in these regulations.

(4) These regulations shall not prevent from designating

certain substances not covered by these regulations as explosives

under other laws or regulations.

For the purpose of these regulations, the following

definitions shall apply

"accreditation" means accreditation as defined in point 10 of

Article 2 of Regulation (EC) No 765/2008;

"ammunition" means projectiles with or without propelling

charges and blank ammunition used in portable firearms, other guns

and artillery;

"approval" means the decision taken to allow envisaged

transfers of explosives within the Union;

"authorised representative" means any natural or legal person

established within the Union who has received a written mandate

from a manufacturer to act on his behalf in relation to specified tasks;

"CE marking" means a marking by which the manufacturer

indicates that the explosive is in conformity with the applicable

requirements set out in Union harmonisation legislation providing for

its affixing;

"conformity assessment body" means a body that performs

conformity assessment activities including calibration, testing,

certification and inspection;

"conformity assessment" means the process demonstrating

whether the essential safety requirements of these regulations relating

to an explosive have been fulfilled;

"dealer" means 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;

"distributor" means any natural or legal person in the supply

chain, other than the manufacturer or the importer, who makes an

explosive available on the market;

"economic operators" means the manufacturer, the authorised

representative, the importer, the distributor and any natural or legal

person who engages in the storage, use, transfer, import, export or

trade of explosives;

"explosives" means the materials and articles considered to be

explosives in the United Nations recommendations on the transport of

dangerous goods and falling within Class 1 of those

recommendations;

"harmonised standard" means harmonised standard as defined in

point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012;

"importer" means any natural or legal person established within

the Union who places an explosive from a third country on the Union

market;

"making available on the market" means any supply of an

explosive for distribution or use on the Union market in the course of

a commercial activity, whether in return for payment or free of

charge;

"manufacturer" means any natural or legal person who

manufactures an explosive or has an explosive designed or

manufactured, and markets that explosive under his name or trade

mark or uses it for his own purposes;

"National Accreditation Board (Malta)" means the National

Accreditation Board (Malta) established in terms of regulation 3 of

the National Accreditation Board (Malta) (Establishment) S.L. 419.07

Regulations;

"national accreditation body" means national accreditation body

as defined in point 11 of Article 2 of Regulation (EC) No 765/2008;

"placing on the market" means the first making available of an

explosive on the Union market;

"recall" means any measure aimed at achieving the return of an

explosive that has already been made available to the end-user;

"safety" means the prevention of accidents and, where

prevention fails, the containment of their effects;

"security" means the prevention of use contrary to law and

order;

"Technical Regulations Division" means the Technical

Regulations Division within the Malta Competition and Consumer

Affairs Authority as established by the Malta Competition and

Consumer Affairs Authority Act;

"technical specification" means a document that prescribes

technical requirements to be fulfilled by an explosive;

"transfer" means any physical movement of explosives within

the Union except movements within one and the same site;

"Union harmonisation legislation" means any Union legislation

harmonising the conditions for the marketing of products;

"withdrawal" means any measure aimed at preventing an

explosive in the supply chain from being made available on the

market;

The making available on the market of explosives which

satisfy the requirements of these regulations shall not be prohibited,

restricted or hindered.

Explosives may be made available on the market only if

they comply with the requirements of these regulations.

(1) When placing their explosives on the market or when

using them for their own purposes, manufacturers shall ensure that

they have been designed and manufactured in accordance with the

requirements set out in Schedule II.

(2) Manufacturers shall draw up the technical documentation

referred to in Schedule III and have the relevant conformity

assessment procedure referred to in regulation 15 carried out.

Where compliance of an explosive with the applicable

requirements has been demonstrated by that procedure, manufacturers

shall draw up an EU declaration of conformity and affix the CE

marking.

(3) Manufacturers shall keep the technical documentation and

the EU declaration of conformity for 10 years after the explosive has

been placed on the market.

(4) Manufacturers shall ensure that procedures are in place for

series production to remain in conformity with these regulations.

Changes in design or characteristics of the explosive and changes in

the harmonised standards or in other technical specifications by

reference to which conformity of an explosive is declared shall be

adequately taken into account.

(5) Manufacturers shall ensure that explosives which they

have placed on the market bear a unique identification in accordance

with the system for the identification and traceability of explosives

set out in regulation 13. For explosives excluded from that system,

manufacturers shall

(a)

ensure that explosives which they have placed on

the market bear a type, batch or serial number or other element

allowing their identification, or, where the small size, shape or

design of the explosive does not allow it, that the required

information is provided on its packaging or in a document

accompanying the explosive;

(b) indicate on the explosive their name, registered

trade name or registered trade mark and the postal address at

which they can be contacted or, where that is not possible, on its

packaging or in a document accompanying the explosive. The

address shall indicate a single point at which the manufacturer

can be contacted. The contact details shall be in at least the

Maltese or the English language.

(6) Manufacturers shall ensure that explosives which they

have placed on the market are accompanied by instructions and safety

information in at least the Maltese or the English language. Such

instructions and safety information, as well as any labelling, shall be

clear, understandable and intelligible.

(7) Manufacturers who consider or have reason to believe that

an explosive which they have placed on the market is not in

conformity with these regulations shall immediately take the

corrective measures necessary to bring that explosive into conformity,

to withdraw it or recall it, if appropriate. Furthermore, where the

explosive presents a risk, manufacturers shall immediately inform the

competent national authorities of the Member States in which they

made the explosive available on the market to that effect, giving

details, in particular, of the non-compliance and of any corrective

measures taken.

(8) Manufacturers shall, further to a reasoned request from the

Commissioner of Police or from the Technical Regulations Division,

provide it with all the information and documentation in paper or

electronic form necessary to demonstrate the conformity of the

explosive with these regulations, in at least the Maltese or the English

language. They shall cooperate with that authority, at its request, on

any action taken to eliminate the risks posed by explosives which

they have placed on the market.

(1) A manufacturer may, by a written mandate, appoint

an authorised representative.

(2) The obligations laid down in regulation 7(1) and the

obligation to draw up technical documentation referred to in

regulation 7(2) shall not form part of the authorised representative’s

mandate.

(3) An authorised representative shall perform the tasks

specified in the mandate received from the manufacturer. The

mandate shall allow the authorised representative to do at least the

following

(a)

keep the EU declaration of conformity and the

technical documentation at the disposal of national surveillance

authorities for 10 years after the product has been placed on the

market;

(b) further to a reasoned request from a competent

national authority, provide that authority with all the

information and documentation necessary to demonstrate the

conformity of an explosive;

(c)

cooperate with the competent national authorities, at

their request, on any action taken to eliminate the risks posed by

explosives covered by the authorised representative’s mandate.

(1)

Importers shall place only compliant explosives on

the market.

(2) Before placing an explosive on the market, importers shall

ensure that the appropriate conformity assessment procedure referred

to in regulation 15 has been carried out by the manufacturer. They

shall ensure that the manufacturer has drawn up the technical

documentation, that the explosive bears the CE marking and is

accompanied by the required documents, and that the manufacturer

has complied with the requirements set out in regulation 7(5).

Where an importer considers or has reason to believe that

an explosive is not in conformity with the essential safety

requirements set out in Schedule II, he shall not place the explosive

on the market until it has been brought into conformity. Furthermore,

where the explosive presents a risk, the importer shall inform the

manufacturer and the market surveillance authorities to that effect.

(3) Importers shall indicate, on the explosive, their name,

registered trade name or registered trade mark and the postal address

at which they can be contacted or, where that is not possible, on its

packaging or in a document accompanying the explosive. The contact

details shall be in at least the Maltese or the English language.

(4) Importers shall ensure that the explosive is accompanied

by instructions and safety information in at least the English or

Maltese language.

(5) Importers shall ensure that, while an explosive is under

their responsibility, its storage or transport conditions do not

jeopardise its compliance with the essential safety requirements set

out in Schedule II.

(6) Importers who consider or have reason to believe that an

explosive which they have placed on the market is not in conformity

with these regulations shall immediately take the corrective measures

necessary to bring that explosive into conformity, to withdraw it or

recall it, if appropriate. Furthermore, where the explosive presents a

risk, importers shall immediately inform the competent national

authorities of the Member States in which they made the explosive

available on the market to that effect, giving details, in particular, of

the non-compliance and of any corrective measures taken. The

competent authorities in the case of products imported into Malta,

shall be the Police and the Technical Regulations Division.

(7) Importers shall, for 10 years after the explosive has been

placed on the market, keep a copy of the EU declaration of

conformity at the disposal of the market surveillance authorities and

ensure that the technical documentation can be made available to

those authorities, upon request.

(9) Importers shall, further to a reasoned request from the

Police or the Technical Regulations Division, provide them with all

the information and documentation in paper or electronic form

necessary to demonstrate the conformity of an explosive in at least

the Maltese or the English language. They shall cooperate with that

authority, at its request, on any action taken to eliminate the risks

posed by products which they have placed on the market.

(1) When making an explosive available on the market Obligations of

distributors shall act with due care in relation to the requirements of distributors.

these regulations.

(2) Before making an explosive available on the market

distributors shall verify that the explosive bears the CE marking, that

it is accompanied by the required documents and by instructions and

safety information in at least the English or Maltese language, and

that the manufacturer and the importer have complied with the

requirements set out in regulation 7(5) and regulation 9(3)

respectively.

Where a distributor considers or has reason to believe that

an explosive is not in conformity with the essential safety

requirements set out in Schedule II, he shall not make the explosive

available on the market until it has been brought into conformity.

Furthermore, where the explosive presents a risk, the distributor shall

inform the manufacturer or the importer, as well as the market

surveillance authorities, to that effect.

(3) Distributors shall ensure that, while an explosive is under

their responsibility, its storage or transport conditions do not

jeopardise its compliance with the essential safety requirements set

out in Schedule II.

(4) Distributors who consider or have reason to believe that an

explosive which they have made available on the market is not in

conformity with these regulations shall make sure that the corrective

measures necessary to bring that explosive into conformity, to

withdraw it or recall it, if appropriate, are taken. Furthermore, where

the explosive presents a risk, distributors shall immediately inform

the competent national authorities of the Member States in which they

made the explosive available on the market to that effect, giving

details, in particular, of the non-compliance and of any corrective

measures taken.

(5) Distributors shall, further to a reasoned request from the

Police and, or the Technical Regulations Division, provide that

authority with all the information and documentation in paper or

electronic form necessary to demonstrate the conformity of an

explosive. They shall cooperate with that authority, at its request, on

any action taken to eliminate the risks posed by explosives which

they have made available on the market.

An importer or distributor shall be considered a

manufacturer for the purposes of these regulations and he shall be

subject to the obligations of the manufacturer under regulation 7,

where he places an explosive on the market under his name or

trademark or modifies an explosive already placed on the market in

such a way that compliance with the requirements of these regulations

may be affected.

(1) For explosives not covered by the system set out in

regulation 13, economic operators shall, on request, identify the

following to the Police and, or the Technical Regulations Division

(a)

any economic operator who has supplied them with

an explosive;

(b) any economic operator to whom they have supplied

an explosive.

(2) Economic operators shall be able to present the

information referred to in sub-regulation (1) for 10 years after they

have been supplied with the explosive and for 10 years after they

have supplied the explosive.

(1) Economic operators shall adhere to a uniform Identification

system for the unique identification and traceability of explosives, and

of explosives.

that takes into account their size, shape or design, except where it is

not necessary to place a unique identification on the explosive due to

its low level of hazard, based on its characteristics and factors such as

its low detonative effects, its uses and the low security risk it presents

due to the low potential effects of misuse.

The system shall not apply to explosives transported and

delivered unpackaged or in pump trucks for their direct unloading

into the blast-hole, or explosives manufactured at blasting sites, and

that are loaded immediately after being produced (in situ production).

(2) That system shall provide for the collection and storage of

data, including where appropriate by electronic means, enabling the

unique identification and traceability of the explosive as well as for

the placement of a unique identification on the explosive and, or its

packaging enabling access to that data. Those data shall relate to the

unique identification of the explosive, including its location while in

the possession of economic operators and the identity of those

economic operators.

(3) The data referred to in sub-regulation (2) shall be tested at

regular intervals and protected against accidental or malicious

damage or destruction. Those data shall be stored for 10 years after

the transaction took place or, where the explosives have been used or

disposed of, 10 years after their use or disposal, even if the economic

operator has ceased trading. They shall be immediately available at

the request of the Police or the Technical Regulations Division.

Explosives, which are in conformity with harmonised Presumption of

standards or parts thereof the references of which have been Conformity

Explosives.

published in the Official Journal of the European Union shall be

presumed to be in conformity with the essential safety requirements

set out in Schedule II covered by those standards or parts thereof.

For the assessment of the conformity of explosives the

manufacturer shall follow one of the following procedures referred to

in Schedule III

(a)

EU-type examination (Module B) and, at the choice

of the manufacturer, any of the following

(i) conformity to type based on internal

production control plus supervised product checks at

random intervals (Module C2);

(ii) conformity to type based on quality assurance

of the production process (Module D);

(iii) conformity to type based on product quality

assurance (Module E);

(iv) conformity to

type

based

on

product

verification (Module F);

(b)

conformity based on unit verification (Module G).

(1) The EU declaration of conformity shall state that the

fulfilment of essential safety requirements set out in Schedule II has

been demonstrated.

(2) The EU declaration of conformity, which shall have the

model structure set out in Schedule IV, shall contain the elements

specified in the relevant modules set out in Schedule III and shall be

continuously updated. It shall be translated into the language or

languages required by the Member State in which the explosive is

placed or made available on the market. For products placed or made

available on the Maltese market, the EU Declaration of Conformity

shall be translated into at least the Maltese or the English language.

(3) Where an explosive is subject to more than one Union act

requiring an EU declaration of conformity, a single EU declaration of

conformity shall be drawn up in respect of all such Union acts. That

declaration shall contain the identification of the Union acts

concerned including their publication references.

(4) By drawing up the EU declaration of conformity, the

manufacturer shall assume responsibility for the compliance of the

explosive with the requirements laid down in these regulations.

(1) The CE marking shall be subject to the general

principles set out in Article 30 of Regulation (EC) No 765/2008.

(2) The CE marking shall be affixed visibly, legibly and

indelibly to the explosive. Where that is not possible or not warranted

on account of the nature of the explosive, it shall be affixed to the

packaging and to the accompanying documents.

(3) The CE marking shall be affixed before the explosive is

placed on the market.

(4) The CE marking shall be followed by the identification

number of the notified body, where that body is involved in the

production control phase.

The identification number of the notified body shall be

affixed by the body itself or, under its instructions, by the

manufacturer or his authorised representative.

(5) The CE marking and, where applicable, the identification

number of the notified body may be followed by any other mark

indicating a special risk or use.

(6) In cases of explosives manufactured for own use,

explosives transported and delivered unpackaged or in Mobile

Explosives Manufacturing Units (MEMUs) for their direct unloading

into the blast-hole, and explosives manufactured at the blasting sites

which are loaded immediately after being produced (in situ

production), the CE marking shall be affixed to the accompanying

documents.

(1) The Technical Regulations Division shall notify the Notification of

European Commission and the other Member States of bodies conformity

assessment

authorised to carry out third-party conformity assessment under these bodies.

regulations.

(2) The Technical Regulations Division shall be responsible

for setting up and carrying out the necessary procedures for the

assessment and notification of conformity assessment bodies for the

purposes of these regulations, and for the monitoring of notified

bodies, including compliance with the provisions of regulations

19(13) to 19(16).

(3) The assessment and monitoring referred to in sub-

regulation (2) shall be carried out by the National Accreditation

Board (Malta).

(4) The Technical Regulations Division shall inform the

European Commission of its procedures for the assessment and

notification of conformity assessment bodies and the monitoring of

notified bodies, and of any changes thereto.

(1) For the purposes of notification under these

regulations, a conformity assessment body shall meet the

requirements laid down in sub-regulations (2) to (11) and in the

Method for Designating Conformity Assessment Bodies Regulations.

(2) A conformity assessment body shall be established under

Maltese law of and have legal personality.

(3) A conformity assessment body shall be a third-party body

independent of the organisation or the explosive it assesses.

(4) (a)

A conformity assessment body, its top level

management and the personnel responsible for carrying out the

conformity assessment tasks shall not be the designer, manufacturer,

supplier, installer, purchaser, owner, user or maintainer of explosives

which they assess, nor the representative of any of those parties. This

shall not preclude the use of explosives that are necessary for the

operations of the conformity assessment body or the use of explosives

for personal purposes.

(b) A conformity assessment body, its top level

management and the personnel responsible for carrying out the

conformity assessment tasks shall not be directly involved in the

design or manufacture, the marketing, installation, use or

maintenance of explosives, or represent the parties engaged in those

activities. They shall not engage in any activity that may conflict with

their independence of judgement or integrity in relation to conformity

assessment activities for which they are notified. This shall in

particular apply to consultancy services.

(c)

Conformity assessment bodies shall ensure that the

activities of their subsidiaries or subcontractors do not affect the

confidentiality, objectivity or impartiality of their conformity

assessment activities.

(5) Conformity assessment bodies and their personnel shall

carry out the conformity assessment activities with the highest degree

of professional integrity and the requisite technical competence in the

specific field and shall be free from all pressures and inducements,

particularly financial, which might influence their judgement or the

results of their conformity assessment activities, especially as regards

persons or groups of persons with an interest in the results of those

activities.

(6) (a)

A conformity assessment body shall be capable of

carrying out all the conformity assessment tasks assigned to it by

Schedule III and in relation to which it has been notified, whether

those tasks are carried out by the conformity assessment body itself or

on its behalf and under its responsibility.

(b) At all times and for each conformity assessment

procedure and each kind or category of explosives in relation to

which it has been notified, a conformity assessment body shall have

at its disposal the necessary

(i) personnel with technical knowledge and

sufficient and appropriate experience to perform the

conformity assessment tasks;

(ii) descriptions of procedures in accordance with

which conformity assessment is carried out, ensuring the

transparency and the ability of reproduction of those

procedures. It shall have appropriate policies and

procedures in place that distinguish between tasks it carries

out as a notified body and other activities;

(iii) procedures for the performance of activities

which take due account of the size of an undertaking, the

sector in which it operates, its structure, the degree of

complexity of the product technology in question and the

mass or serial nature of the production process.

(c)

A conformity assessment body shall have the means

necessary to perform the technical and administrative tasks connected

with the conformity assessment activities in an appropriate manner

and shall have access to all necessary equipment or facilities.

(7) The personnel responsible for carrying out conformity

assessment tasks shall have the following

(a)

sound technical and vocational training covering all

the conformity assessment activities in relation to which the

conformity assessment body has been notified;

(b) satisfactory knowledge of the requirements of the

assessments they carry out and adequate authority to carry out

those assessments;

(c)

appropriate knowledge and understanding of the

essential safety requirements set out in Schedule II, of the

applicable harmonised standards and of the relevant provisions

of Union harmonisation legislation and of the relevant national

legislation;

(d)

the ability to draw up certificates, records and

reports demonstrating that assessments have been carried out.

(8) The impartiality of conformity assessment bodies, their top

level management and of the personnel responsible for carrying out

the conformity assessment tasks shall be guaranteed. The

remuneration of the top level management and personnel responsible

for carrying out the conformity assessment tasks of a conformity

assessment body shall not depend on the number of assessments

carried out or on the results of those assessments.

(9) Conformity assessment bodies shall take out liability

insurance unless liability is assumed by the State in accordance with

national law, or the Member State itself is directly responsible for the

conformity assessment.

(10) The personnel of a conformity assessment body shall

observe professional secrecy with regard to all information obtained

in carrying out their tasks under Schedule III or any provision of

national law giving effect to it, except in relation to the competent

authorities of the Member State in which its activities are carried out.

Proprietary rights shall be protected.

(11) Conformity assessment bodies shall participate in, or

ensure that their personnel responsible for carrying out the

conformity assessment tasks are informed of, the relevant

standardisation activities and the activities of the notified body

coordination group established under the relevant Union

harmonisation legislation and shall apply as general guidance the

administrative decisions and documents produced as a result of the

work of that group.

(12) Where a conformity assessment body demonstrates its

conformity with the criteria laid down in the relevant harmonised

standards or parts thereof, the references of which have been

published in the Official Journal of the European Union, it shall be

presumed to comply with the requirements set out in sub-regulations

(1) to (11) insofar as the applicable harmonised standards cover those

requirements.

(13) Where a notified body subcontracts specific tasks

connected with conformity assessment or has recourse to a subsidiary,

it shall ensure that the subcontractor or the subsidiary meets the

requirements set out in sub-regulations (1) to (11), and shall inform

the Technical Regulations Division accordingly.

(14) Notified bodies shall take full responsibility for the tasks

performed by subcontractors or subsidiaries, wherever these are

established.

(15) Activities may be subcontracted or carried out by a

subsidiary only with the agreement of the client.

(16) Notified bodies shall keep at the disposal of the Technical

Regulations Division the relevant documents concerning the

assessment of the qualifications of the subcontractor or the subsidiary

and the work carried out by them under regulations Schedule III.

(1) A conformity assessment body established in Malta Notification

shall submit an application for notification under these regulations to procedures.

the Technical Regulations Division.

(2) The application referred to in sub-regulation (1) shall be

accompanied by a description of the conformity assessment activities,

the conformity assessment module or modules and the explosive or

explosives for which that body claims to be competent, as well as by

an accreditation certificate issued by the National Accreditation

Board (Malta) attesting that the conformity assessment body fulfils

the requirements laid down in regulations 19(1) to 19(11) and the

Method for Designating Conformity Assessment Bodies Regulations. S.L. 427.45

(3) The Technical Regulations Division may only notify

conformity assessment bodies which have satisfied the requirements

laid down in regulations 19(1) to 19(11) and the Method for

Designating Conformity Assessment Bodies Regulations.

(4) The Technical Regulations Division shall notify

conformity assessment bodies to the European Commission and the

other Member States using the electronic notification tool developed

and managed by the Commission.

(5) The notification shall include full details of the conformity

assessment activities, the conformity assessment module or modules,

explosive or explosives concerned and the relevant attestation of

competence.

(6) The body concerned may perform the activities of a

notified body only where no objections are raised by the European

Commission or the other Member States within two weeks of a

notification. Only such a body shall be considered a notified body for

the purposes of these regulations.

(7) The Technical Regulations Division shall notify the

European Commission and the other Member States of any

subsequent relevant changes to the notification.

(8) Where the Technical Regulations Division has ascertained

or has been informed that a notified body no longer meets the

requirements laid down in regulations 19(1) to 19(11) or the Method

for Designating Conformity Assessment Bodies Regulations or that it

is failing to fulfil its obligations, the Technical Regulations Division

shall restrict, suspend or withdraw notification as appropriate,

depending on the seriousness of the failure to meet those

requirements or fulfil those obligations. It shall immediately inform

the European Commission and the other Member States accordingly.

(9) In the event of restriction, suspension or withdrawal of

notification, or where the notified body has ceased its activity, the

Technical Regulations Division shall take appropriate steps to ensure

that the files of that body are either processed by another notified

body or kept available to the responsible notifying and market

surveillance authorities, at their request.

(10) The Technical Regulations Division shall provide the

Commission, on request, with all information relating to the basis for

the notification or the maintenance of the competence of the body

concerned.

(1) Notified bodies shall carry out

conformity

assessments in accordance with the conformity

assessment

procedures provided for in Schedule III.

(2) Conformity assessments shall be carried out in a

proportionate manner, avoiding unnecessary burdens for economic

operators and private importers. Conformity assessment bodies shall

perform their activities taking due account of the size of an

undertaking, the sector in which it operates, its structure, the degree

of complexity of the product technology in question and the mass or

serial nature of the production process. In so doing, they shall

nevertheless respect the degree of rigour and the level of protection

required for the compliance of the explosive with these regulations.

(3) Where a notified body finds that the essential safety

requirements set out in Schedule II or in corresponding harmonised

standards or other technical specifications have not been met by a

manufacturer, it shall require the manufacturer to take appropriate

corrective measures and shall not issue a certificate of conformity.

(4) Where, in the course of the monitoring of conformity

following the issue of a certificate, a notified body finds that an

explosive is no longer in compliance; it shall require the manufacturer

to take appropriate corrective measures and shall suspend or

withdraw the certificate if necessary.

(5) Where corrective measures are not taken or do not have the

required effect, the notified body shall restrict, suspend or withdraw

any certificates, as appropriate.

(6) Notified bodies shall inform the Technical Regulations

Division of the following

(a)

any refusal, restriction, suspension or withdrawal of

a certificate;

(b) any circumstances affecting the scope of or

conditions for notification;

(c)

any request for information which they have

received from market surveillance authorities regarding

conformity assessment activities;

(d) on request, conformity assessment activities

performed within the scope of their notification and any other

activity performed, including cross-border activities and

subcontracting.

(7) Notified bodies shall provide the other bodies notified

under the Directive carrying out similar conformity assessment

activities covering the same products with relevant information on

issues relating to negative and, on request, positive conformity

assessment results.

(8) Notified bodies shall participate, directly or by means of

designated representatives, in the appropriate coordination and

cooperation groups for notified bodies organised by the European

Commission.

(1) The Police shall take appropriate measures to ensure Market

that explosives may be placed on the market only if, when properly surveillance.

stored and used for their intended purpose, they do not endanger the

health and safety of persons.

(2) Articles 16 to 29 of Regulation (EC) No 765/2008 shall

apply to explosives.

(3) Where the Police has sufficient reasons to believe that an

explosive presents a risk to the health or safety of persons, to property

or to the environment, they shall carry out an evaluation in relation to

the explosive concerned covering all relevant requirements laid down

in these regulations. The relevant economic operators shall cooperate

as necessary with the Police.

(4) Where, in the course of the evaluation referred to in sub-

regulation (3), the Police finds that the explosive does not comply

with the requirements laid down in these regulations, they shall

without delay require the relevant economic operator to take all

appropriate corrective action to bring the explosive into compliance

with those requirements, to withdraw the explosive from the market,

or to recall it within a reasonable period, commensurate with the

nature of the risk, as it may prescribe. It shall also inform the Notified

Body accordingly. The Police shall also inform the Technical

Regulations Division.

(5) Article 21 of Regulation (EC) No 765/2008 shall apply to

the measures referred to in sub-regulation (4).

(6) Where the Police, in collaboration with the Technical

Regulations Division, considers that non-compliance is not restricted

to the Maltese territory, it shall inform the European Commission and

the other Member States of the results of the evaluation and of the

actions which it has required the economic operator to take.

(7) The economic operator shall ensure that all appropriate

corrective action is taken in respect of all the explosives concerned

that it has made available on the market throughout the European

Union.

(8) Where the relevant economic operator does not take

adequate corrective action within the period referred to in regulation

22(4), the Police shall take all appropriate provisional measures to

prohibit or restrict the explosives being made available on the

Maltese market, to withdraw the explosive from this market or to

recall it. The Police shall inform the Technical Regulations Division

of such measures.

(9) The Technical Regulations Division shall inform the

European Commission and the other Member States, without delay, of

those measures referred to in sub-regulation (8).

(10) The information referred to in sub-regulation (9) shall

include all available details, in particular the data necessary for the

identification of the non-compliant explosive, the origin of the

explosive, the nature of the non-compliance alleged and the risk

involved, the nature and duration of the national measures taken and

the arguments put forward by the relevant economic operator. In

particular, the Police, in collaboration with Technical Regulations

Division, shall indicate whether the non-compliance is due to either

of the following

(a)

failure of the explosive to meet requirements

relating to the health or safety of persons, the protection of

property or the environment laid down in these regulations; or

(b) shortcomings in the harmonised standards referred

to in regulation 14 conferring a presumption of conformity.

(11) When the procedure under this regulation is initiated by

another Member State, the Technical Regulations Division, in

collaboration with the Police, shall without delay inform the

European Commission and the other Member States of any measures

adopted and of any additional information at their disposal relating to

the non-compliance of the explosive concerned, and, in the event of

disagreement with the adopted national measure, of their objections.

(12) Where, within three months of receipt of the information

referred to in sub-regulation (9), no objection has been raised by

either a Member State or the European Commission in respect of a

provisional measure taken by a Member State, that measure shall be

deemed justified.

In such cases, the Police shall ensure that appropriate

restrictive measures are taken in respect of the explosive concerned,

such as withdrawal of the explosive from the Maltese market, without

delay.

(13) Where on completion of the procedure set out in sub-

regulations (7) to (8), objections are raised against a measure taken by

the Police, or where the European Commission considers a national

measure to be contrary to European Union legislation, the European

Commission shall without delay enter into consultation with the

Member States and the relevant economic operator or operators and

shall evaluate the national measure. On the basis of the results of that

evaluation, the Commission shall adopt an implementing act

determining whether the national measure is justified or not.

If, on the basis of this evaluation, the national measure is

considered justified, the Police shall ensure that the non-compliant

explosive is withdrawn from the Maltese market and shall inform the

Technical Regulations Division and the European Commission

accordingly.

If, on the basis of this evaluation, the national measure is

considered unjustified, the national measure shall be withdrawn.

(14) Where, having carried out an evaluation under regulation

22(3), the Police finds that although an explosive is in compliance

with these regulations, it presents a risk to the health or safety of

persons, or to property or the environment, it shall require the

relevant economic operator to take all appropriate measures to ensure

that the explosive concerned, when placed on the market, no longer

presents that risk, to withdraw the explosive from the market or to

recall it within a reasonable period, commensurate with the nature of

the risk, as it may prescribe.

(15) The economic operator shall ensure that corrective action

is taken in respect of all the explosives concerned that he has made

available on the market throughout the European Union.

(16) The Police, upon consultation with the Technical

Regulations Division, shall immediately inform the Commission and

the other Member States. That information shall include all available

details, in particular the data necessary for the identification of the

explosive concerned, the origin and the supply chain of the explosive,

the nature of the risk involved and the nature and duration of the

national measures taken.

(17) Without prejudice to sub-regulations (3) to (12), where the

Police makes one of the following findings, it shall require the

relevant economic operator to put an end to the non-compliance

concerned

(a)

the CE marking has been affixed in violation of

Article 30 of Regulation (EC) No 765/2008 or of regulations

17(2) to 17(6);

(b)

the CE marking has not been affixed;

(c)

the identification number of the notified body, where

that body is involved in the production control phase, has been

affixed in violation of regulations 17(2) to 17(6) or has not been

affixed;

(d) the EU declaration of conformity has not been

drawn up;

(e)

the EU declaration of conformity has not been

drawn up correctly;

(f)

technical documentation is either not available or

not complete;

(g) the information referred to in regulation 7(5) or

regulation 9(3) is absent, false or incomplete;

(h) any other administrative requirement provided for in

regulation 7 or regulation 9 is not fulfilled.

(18) Where the non-compliance referred to in sub-regulation

(17) persists, the Police shall take all appropriate measures to restrict

or prohibit the explosive being made available on the Maltese market

or ensure that it is recalled or withdrawn from the Maltese market.

(1) Explosives may be transferred only in accordance Transfers of

explosives.

with sub-regulations (2) to (8).

(2) Approval to transfer explosives shall be obtained by the

consignee from the Commissioner of Police. The Commissioner of

Police shall verify that the consignee is legally authorised to acquire

explosives and that he is in possession of a licence in terms of these

Regulations. The economic operator responsible for the transfer shall

notify the competent authorities of the transit Member State of any

movement of explosives through the Member State concerned and

shall obtain prior approval of the transit Member State concerned.

Whenever explosives are transited through Malta, the Commissioner

of Police shall be notified and the transit shall take place only if

approval has been issued.

(3) Where the Commissioner of Police considers that there is a

problem regarding the verification of the entitlement to acquire

explosives referred to in sub-regulation (2), the Commissioner of

Police shall forward the available information on the subject to the

Commission which shall inform the other Member States thereof.

(4) Where the Commissioner of Police approves a transfer, the

Commissioner of Police shall issue to the consignee a document

which includes all the information referred to in sub-regulation (5).

Such a document shall accompany the explosives until they arrive at

their stated destination. It shall be produced at the request of the

relevant competent authorities. A copy of that document shall be

retained by the consignee who shall present it, upon request, for

examination by the Commissioner of Police.

(5) Prior to the transfer of explosives, the following

information shall be provided by the consignee to the Commissioner

of Police

(a)

the names and addresses of the economic operators

concerned;

(b) the number and quantity of the explosives being

transferred;

(c)

a full description of the explosives in question and

of the means of identification, including the United Nations

identification number;

(d) where the explosives are to be placed on the market,

information on compliance with conditions for placing on the

market;

(e)

the means of transfer and the itinerary;

(f)

the expected dates of departure and arrival;

(g) where necessary, the precise points of entry to and

exit from Malta.

The Commissioner of Police shall examine the conditions

under which the transfer may take place, with particular regard to

security requirements. If such requirements are satisfied, approval for

the transfer shall be granted.

(6) At the request of the Commissioner of Police, the

consignees and the economic operators concerned shall forward the

required information concerning the transfer of explosives whenever

Malta is the state of departure or the state of transit.

(7) No economic operator may transfer explosives unless the

consignee has obtained the necessary licences for the transfer in

accordance with sub-regulations (2), (4) and (5).

(1) Ammunition may be transferred between Malta and

other Member States only in accordance with the procedure laid down

in sub-regulations (2) to (5) which sub-regulations shall also apply to

transfers of ammunition under mail-order sales.

(2) Where ammunition is to be transferred to another Member

State the person concerned shall, before any dispatch, communicate

to the Commissioner of Police the following

(a)

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;

(b) the address to which the ammunition is to be

consigned or transported;

(c)

the quantity of ammunition to be consigned or

transported;

(d) 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 July 1969 on the

Reciprocal Recognition of Proofmarks on Small Arms;

(e)

the means of transfer;

(f)

the date of departure and the estimated date of

arrival.

The information referred to in paragraphs (e) and (f) need not be

supplied in the case 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. Where the

Commissioner of Police authorises such a transfer, the Commissioner

of Police shall issue an authorisation incorporating all the particulars

referred to in the sub-regulation (2). That licence shall accompany the

ammunition until it reaches its destination. It shall be produced

whenever so required by the competent authorities.

(3) The Commissioner of Police may grant dealers the right to

effect transfers of ammunition from its territory to a dealer

established in another Member State without the prior authorisation

referred to in sub-regulation (2). To that end, the Commissioner of

Police shall issue an authorisation valid for three years which may at

any time be suspended or cancelled by reasoned decision. A

document referring to that authorisation shall accompany the

ammunition until it reaches its destination. It shall be produced

whenever so required by the competent authorities of the Member

States.

Before effecting the transfer, the dealer shall communicate

to the Commissioner of Police all the particulars listed in sub-

regulation (2).

(4) The competent authorities shall supply the other Member

States with a list of the ammunition the transfer of which to its

territory may be authorised without its prior consent.

Such lists of ammunition shall be communicated to dealers

who have obtained approval for transferring ammunition without

prior authorisation in accordance with the procedure laid down in

sub-regulation (3).

(5) The Commissioner of Police shall communicate all

relevant information concerning definitive transfers of ammunition to

the competent authorities of the Member State, to the territory of

which such a transfer has been affected.

All information that the Commissioner of Police receives

in accordance with this Regulation shall be communicated, not later

than the time of the relevant transfers, to the Member States of

destination and, where appropriate, not later than the time of transfer

to the Member States of transit.

By way of derogation from regulation 23(2), (4) and (5)

and from regulation 24, the Commissioner of Police, in the event of

serious threats to, or attacks on, public security as a result of illicit

possession or use of explosives or ammunition, may take all

necessary measures concerning transfers of explosives or ammunition

in order to prevent such illicit possession or use.

The measures referred to in the first paragraph shall

respect the principle of proportionality. They shall constitute neither a

means of arbitrary discrimination nor a veiled restriction in trade

between Member States.

If such measures are adopted, these measures shall be

notified to the Commission forthwith.

(1) Economic operators shall be in possession of a

licence which entitles them to engage in the manufacture, storage,

use, import, export, transfer or trade of explosives.

(2) Sub-regulation (1) shall not apply to employees of an

economic operator possessing a licence.

Whenever the Commissioner of Police issues a licence in

accordance with regulation 26, the Commissioner of Police shall seek

the advice of the Explosives Committee or of the Malta Competition

and Consumer Affairs Authority in relation to the compliance of

operators with technical commitments.

The penalties applicable for the infringement of any of the

provisions of these regulations shall be those provided for in the

Explosives Ordinance.

The Civil Explosives Regulations and the Civil Explosives

(Identification) Regulations are hereby revoked.

(1) Any references to the Regulations mentioned in

regulation 29 shall be construed as references to these regulations.

(2) Any references in existing laws, regulations and

administrative provisions to Directive 93/15/EEC as amended and to

Directive 2004/57/EC shall be construed as references to Directive

2014/28/EU.

Schedule I

ARTICLES CONSIDERED IN THE RELEVANT UNITED NATIONS

RECOMMENDATIONS TO BE PYROTECHNIC OR AMMUNITION

UN

NAME and

CLASS/

GLOSSARY (to be used as a guide for

No

DESCRIPTION

DIVISION

information only)

Group G

Ammunition, Incendiary 1.2 G

Ammunition

with or without burster,

Generic term related mainly to articles

expelling

charge

or

of military application consisting of all

propelling charge

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.

Ammunition, Incendiary 1.3 G

See Entry for UN No 0009

with or without burster,

expelling

charge

or

propelling charge

Ammunition,

Smoke 1.2 G

Ammunition, Smoke

with or without burster,

Ammunition

containing

smoke-

expelling

charge

or

producing substance. Except when the

propelling charge

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.

Ammunition,

Smoke 1.3 G

See Entry for UN No 0015

with or without burster,

expelling

charge

or

propelling charge

UN

NAME and

CLASS/

GLOSSARY (to be used as a guide for

No

DESCRIPTION

DIVISION

information only)

Ammunition,

Tear- 1.2 G

Ammunition,

Tear-producing

with

producing with burster,

burster, expelling charge or propelling

expelling

charge

or

charge

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.

Ammunition,

Tear- 1.3 G

See Entry for UN No 0018

producing with burster,

expelling

charge

or

propelling charge

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.

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.

Cartridges, Flash

1.3 G

See Entry for UN No 0049

Cartridges, Signal

1.3 G

Cartridges, Signal

Articles designed to fire coloured flares

or other signals from signal pistols, etc.

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.

Flares, Surface

1.3 G

Flares Articles containing pyrotechnic

substances which are designed for use to

illuminate, identify, signal or warn.

Flares, Aerial

1.3 G

See Entry for UN No 0092

UN

NAME and

CLASS/

GLOSSARY (to be used as a guide for

No

DESCRIPTION

DIVISION

information only)

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.

Fuse, Igniter,

tubular, 1.4 G

Fuse, igniter, tubular, metal clad

metal clad

Article consisting of a metal tube with a

core of deflagrating explosive.

Ammunition,

1.2 G

Ammunition, illuminating with or

illuminating with or

without burster, expelling charge or

without burster, expelling

propelling charge

charge or propelling

Ammunition designed to produce a

charge

single source of intense light for lighting

up an area. The term includes

illuminating cartridges, grenades and

projectiles; and illuminating and target

identification bombs.

Signal devices, hand

1.4 G

Articles designed to produce signals.

Signals, railway track, 1.1 G

See Entry for UN No 0191

explosive

Signals, distress, ship

1.1 G

See Entry for UN No 0191

Signals, distress, ship

1.3 G

See Entry for UN No 0191

Signals, smoke

1.1 G

See Entry for UN No 0191

Signals, smoke

1.4 G

See Entry for UN No 0191

Tracers for ammunition

1.3 G

Tracers for ammunition

Sealed articles containing pyrotechnic

substances, designed to reveal the

trajectory of a projectile.

UN

NAME and

CLASS/

GLOSSARY (to be used as a guide for

No

DESCRIPTION

DIVISION

information only)

Ammunition,

1.3 G

See Entry for UN No 0171

illuminating with or

without burster, expelling

charge or propelling

charge

Ammunition,

1.4 G

See Entry for UN No 0254

illuminating with or

without burster, expelling

charge or propelling

charge

Bombs, photo-flash

1.3 G

See Entry for UN No 0039

Ammunition, incendiary 1.4 G

See Entry for UN No 0009

with or without burster,

expelling

charge

or

propelling charge

Ammunition,

tear- 1.4 G

See Entry for UN No 0018

producing with burster,

expelling charge

Ammunition, smoke with 1.4 G

See Entry for UN No 0015

or

without

burster,

expelling charge

Tracers for ammunition

1.4 G

See Entry for UN No 0212

Cartridges, signal

1.4 G

Cartridges, signal

Articles designed to fire coloured flares

or other signals from signal pistols.

Signals, smoke

1.2 G

See Entry for UN No 0195

Grenades, practice, hand 1.3 G

Grenades hand or rifle

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.

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.

Primers, tubular

1.4 G

See Entry for UN No 0319

Fireworks

1.1 G

Fireworks

Pyrotechnic articles

designed

for

entertainment.

Fireworks

1.2 G

See Entry for UN No 0333

Fireworks

1.3 G

See Entry for UN No 0333

UN

NAME and

CLASS/

GLOSSARY (to be used as a guide for

No

DESCRIPTION

DIVISION

information only)

Fireworks

1.4 G

See Entry for UN No 0333

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.

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.

Grenades, practice, hand 1.2 G

See Entry for UN No 0318

or rifle

Signal devices, hand

1.4 S

See Entry for UN No 0191

Flares, aerial

1.4 G

See Entry for UN No 0092

Flares, surface

1.2 G

See Entry for UN No 0092

Flares, surface

1.1 G

See Entry for UN No 0092

Flares, aerial

1.1 G

See Entry for UN No 0092

Flares, aerial

1.2 G

See Entry for UN No 0092

Projectiles,

inert

with 1.3 G

Projectiles

tracer

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.

Projectiles,

inert

with 1.4 G

See Entry for UN No 0424

tracer

UN

NAME and

CLASS/

GLOSSARY (to be used as a guide for

No

DESCRIPTION

DIVISION

information only)

Articles, pyrotechnic for 1.1 G

Articles,

pyrotechnic

for

technical

technical purposes

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.

Articles, pyrotechnic for 1.2 G

See Entry for UN No 0428

technical purposes

Articles, pyrotechnic for 1.3 G

See Entry for UN No 0428

technical purposes

Articles, pyrotechnic for 1.4 G

See Entry for UN No 0428

technical purposes

Projectiles with burster or 1.2 G

Projectiles

expelling charge

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.

Projectiles with burster or 1.4 G

See Entry for UN No 0434

expelling charge

Grenades, practice, hand 1.4 G

See Entry for UN No 0372

or rifle

Signal, smoke

1.3 G

See Entry for UN No 0194

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.

Signals, railway track, 1.3 G

See Entry for UN No 0194

explosive

NAME and

CLASS/

GLOSSARY (to be used as a guide for

DESCRIPTION

DIVISION

information only)

Signals, railway track, 1.4 G

See Entry for UN No 0194

explosive

Air bag inflators, or 1.4 G

Airbag modules, or seat

belt pre-tensioners,

Grenades, practice, hand 1.4 S

See Entry for UN No 0318

or rifle

Signals, railway track, 1.4 S

See Entry for UN No 0194

explosive

Fireworks

1.4 S

See Entry for UN No 0334

Projectiles,

inert

with 1.4 S

Projectiles

tracer

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.

Primers, tubular

1.4 S

See Entry for UN No 0319

Flares, aerial

1.4 S

See Entry for UN No 0092

Cartridges, signal

1.4 S

Cartridges, Signal

Articles designed to fire coloured flares

or other signals from signal pistols, etc.

Articles, pyrotechnic or 1.4 S

technical purpose

Schedule II

ESSENTIAL SAFETY REQUIREMENTS

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

Blasting explosives shall also comply with the following requirements

(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 fumes produced by blasting explosives intended for

underground use may contain carbon monoxide, nitrous gases, other

gases, vapours or airborne solid residues only in quantities which do

not impair health under normal operating conditions.

Detonating cords, safety fuses, other fuses and shock tubes shall also

comply with the following requirements

(a)

the covering of detonating cords, safety fuses, other fuses and shock

tubes must be of adequate mechanical strength and adequately

protect the explosive filling when exposed to normal mechanical

stress;

(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 shall also comply

with the following requirements

(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)

delay connectors for detonating cords must be 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);

(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 shall also comply with the following

requirements

(a)

these materials must not detonate when used for their intended

purpose;

(b)

propellants where necessary (e.g. those based on nitrocellulose)

must be stabilised 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 III

CONFORMTIY 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 these regulations 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

(a)

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

lodged by the authorised representative, his name and address as

well;

(b)

a written declaration that the same application has not been lodged

with any other notified body;

(c)

the technical documentation. The technical documentation shall

make it possible to assess the explosive’s conformity with the

applicable requirements of these regulations 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

contain wherever applicable, at least the following elements

(i)

a general description of the explosive;

(ii) conceptual design and manufacturing drawings and schemes

of components, sub-assemblies, circuits, etc.;

(iii) descriptions and explanations necessary for the understanding

of those drawings and schemes and the operation of the

explosive;

(iv) a list of the harmonised standards applied in full or in part the

references of which have been published in the Official

Journal of the European Union and, where those harmonised

standards have not been applied, descriptions of the solutions

adopted to meet the essential safety requirements of these

regulations, including a list of other relevant technical

specifications applied. In the event of partly applied

harmonised standards, the technical documentation shall

specify the parts which have been applied;

(v)

results of design calculations made, examinations carried out,

etc.;

(vi) test reports;

(d)

the specimens representative of the production envisaged. The

notified body may request further specimens if needed for carrying

out the test programme;

(e)

the supporting evidence for the adequacy of the technical design

solution. This supporting evidence shall mention any documents

that have been used, in particular where the relevant harmonised

standards have not been applied in full. The supporting evidence

shall include, where necessary, the results of tests carried out in

accordance with other relevant technical specifications by the

appropriate laboratory of the manufacturer, or by another testing

laboratory on his behalf and under his responsibility.

4. The notified body shall

For the explosive

examine the technical documentation and supporting evidence to assess

the adequacy of the technical design of the explosive.

For the specimen(s)

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;

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;

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 these regulations;

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 these regulations 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 these

regulations, 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 these

regulations, 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 these regulations 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 these regulations 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 these regulations

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 these

regulations. 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

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 these

regulations.

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 these regulations

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

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

(a)

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

lodged by the authorised representative, his name and address as

well;

(b)

a written declaration that the same application has not been lodged

with any other notified body;

(c)

all relevant information for the explosive category envisaged;

(d)

the documentation concerning the quality system;

(e)

the technical documentation of the approved type and a copy of the

EU-type examination certificate.

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 these regulations 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

(a)

the quality objectives and the organisational structure,

responsibilities and powers of the management with regard to

product quality;

(b)

the corresponding manufacturing, quality control and quality

assurance techniques, processes and systematic actions that will be

used;

(c)

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

and after manufacture, and the frequency with which they will be

carried out;

(d)

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

calibration data, qualification reports on the personnel concerned,

etc.;

(e)

the means of monitoring the achievement of the required product

quality and the effective operation of the quality system.

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 these regulations. 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 these regulations 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.

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.

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

The purpose of surveillance is to make sure that the manufacturer duly

fulfils the obligations arising out of the approved quality system.

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

(a)

the quality system documentation;

(b)

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

calibration data, qualification reports on the personnel concerned,

etc.

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.

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

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 these regulations.

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 these regulations 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

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

(a)

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

lodged by the authorised representative, his name and address as

well;

(b)

a written declaration that the same application has not been lodged

with any other notified body;

(c)

all relevant information for the explosive category envisaged;

(d)

the documentation concerning the quality system;

(e)

the technical documentation of the approved type and a copy of the

EU-type examination certificate.

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 these regulations.

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

(a)

the quality objectives and the organisational structure,

responsibilities and powers of the management with regard to

product quality;

(b)

the examinations and tests that will be carried out after

manufacture;

(c)

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

calibration data, qualification reports on the personnel concerned,

etc.;

(d)

the means of monitoring the effective operation of the quality

system.

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 these regulations. 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 these regulations 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.

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.

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

The purpose of surveillance is to make sure that the manufacturer duly

fulfils the obligations arising out of the approved quality system.

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

(a)

the quality system documentation;

(b)

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

calibration data, qualification reports on the personnel concerned,

etc.

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.

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

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 these regulations.

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 these regulations 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 these

regulations 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 these regulations.

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

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 these

regulations. 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 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

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.

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 these

regulations 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.

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.

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

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 these regulations.

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 these regulations that

apply to it.

2. Technical documentation

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

(a)

a general description of the explosive;

(b)

conceptual design and manufacturing drawings and schemes of

components, sub-assemblies, circuits, etc.;

(c)

descriptions and explanations necessary for the understanding of

those drawings and schemes and the operation of the explosive;

(d)

a list of the harmonised standards applied in full or in part the

references of which have been published in the Official Journal of

the European Union and, where those harmonised standards have

not been applied, descriptions of the solutions adopted to meet the

essential safety requirements of these regulations, including a list of

other relevant technical specifications applied. In the case of partly

applied harmonised standards, the technical documentation shall

specify the parts which have been applied;

(e)

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

and

(f) t est reports.

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 these

regulations.

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 these regulations, 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

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 these regulations.

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.

Schedule IV

EU DECLARATION OF CONFORMITY No xxxxx *

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

* It is optional to assign a number to the declaration of conformity.

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)

B

€4.86