MAKING AVAILABLE ON THE MARKET OF EXPLOSIVES FOR CIVIL USES REGULATIONS

SUBSIDIARY LEGISLATION 33.07

MAKING AVAILABLE ON THE MARKET OF

EXPLOSIVES FOR CIVIL USES REGULATIONS

28th June, 2016

LEGAL NOTICE 241 of 2016.

(1) The title of these regulations is Making Available on

the Market of Explosives for Civil Uses Regulations.

(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

by the Civil Explosives Regulations which are in conformity with

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

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 Regulations;

(c) ammunition, save as provided for in regulations 24 and

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

articles referred to in sub-regulation (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.

4. 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)

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;

" Te c h n i c a l R e g u l a t i o n s D i v i s i o n " m e a n s t h e Te c h n i c a l

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 preven ting an

explosive in the supply chain from being made available on the

market;

5. The making available on the market of explosives which

satisfy the requirements of these regulations shall not be

prohibited, restricted or hindered.

6. Explosives may be made available on the market only if

they comply with the requirements of these regulations.

7. (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

c orrective measure s n ece ssary to br in g t ha t ex pl os i v e i nt o

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.

8. (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.

9. (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 exp losi ve is no t i n con fo rm i ty wi th t he essent ial safety

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

o n t h e m a r k e t u n t i l i t h a s b e e n b r o u g h t i n t o c o n f o r m i t y.

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

c orrective measure s n ece ssary to br in g t ha t ex pl os i v e i nt o

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.

(8) 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.

10. (1) When making an explosive available on the market

distributors shall act with due care in relation to the requirements

of 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

a n ex pl os i ve is n ot i n conf o rm it y wi th th e e s s e n ti a l s a f e ty

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

co nformi ty wi th th ese regu lat io ns sh all m ake su re th at the

c orrective measure s n ece ssary to br in g t ha t ex pl os i v e i nt o

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.

11. 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.

12. (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.

13. (1) Economic operators shall adhere to a uniform system

for the unique identification and traceability 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.

14. Explosives, which are in conformity with harmonised

standards or parts thereof the references of which have been

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.

15. 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).

16. (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.

17. (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 i ts 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

E xp l osi v e s Ma n uf a c tu r in g U n it s (M EMUs) 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.

18. (1) The Technical Regulations Division shall notify the

European Commission and the other Member States of bodies

authorised to carry out third-party conformity assessment under

these 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.

19. (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.

20. (1) A conformity assessment body established in Malta

shall submit an application for notification under these regulations

to 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.

(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

bo d y o nl y w he r e no ob j e c t i on s ar e r a i s e d by t h e E u ro p e a n

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 Co mmission and the ot her Mem ber Stat es 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.

21. (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.

22. (1) The Police shall take appropriate measures to ensure

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

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 a ction with in t he per io d re f e r re d 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.

I n p a r t i c u l a r, t h e P o l i c e , i n c o l l a b o r a t i o n w i t h Te c h n i c a l

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 Co mmission and the ot her Mem ber Stat es 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.

23. (1) Explosives may be transferred only in accordance with

sub-regulations (2) to (7).

(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

requi red information concerning the tran sfer o f 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).

24. (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.

25. 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.

(1) Any references to the Civil Explosives Regulations

and the Civil Explosives (Identification) Regulations, revoked by

these regulations, 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

p r o p e l l i n g c h a rg e w i t h p r i m e r a n d

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 with

1.2 G

Ammunition, Smoke

o r w i t h o u t b u r s t e r,

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 with

1.3 G

See Entry for UN No 0015

o r w i t h o u t b u r s t e r,

expelling charge or

propelling charge

A m m u n i t i o n , Te a r -

1.2 G

A m m u n i t i o n , Te a r - p r o d u c i n g w i t h

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.

A m m u n i t i o n , Te a r -

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

c h a rg e . T h e t e r m i n c l u d e s : b o m b s ,

photo-flash.

MAKING AVAILABLE ON THE MARKET

OF EXPLOSIVES FOR CIVIL USES

UN

NAME and

CLASS/

GLOSSARY (to be used as a guide for

No

DESCRIPTION

DIVISION

information only)

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

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.

F u s e , I g n i t e r, t u b u l a r,

1.4 G

Fuse, igniter, tubular, metal clad

metal clad

Article consisting of a metal tube with a

core of deflagrating explosive.

MAKING AVAILABLE ON THE MARKET

OF EXPLOSIVES FOR CIVIL USES

UN

NAME and

CLASS/

GLOSSARY (to be used as a guide for

No

DESCRIPTION

DIVISION

information only)

Ammunition,

1.2 G

Ammunition, illuminating with or

illuminating with or

without burster, expelling charge or

without burster, expelling

propelling charge

charge or propelling

A m m u n i t i o n d e s i g n e d t o pr o d u c e 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.

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

o r w i t h o u t b u r s t e r,

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

MAKING AVAILABLE ON THE MARKET

OF EXPLOSIVES FOR CIVIL USES

UN

NAME and

CLASS/

GLOSSARY (to be used as a guide for

No

DESCRIPTION

DIVISION

information only)

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

i g n i t io n a n d a n au x i l i ar y c h arge o f

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

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.

T hey may be iner t, wit h or wit hout

t r a c e r, o r m a y c o n t a i n a b u r s t e r o r

expelling charge or a bursting charge.

The term includes: Projectiles, inert,

with tracer; projectiles with burster or

expelling charge; projectiles with

bursting charge.

MAKING AVAILABLE ON THE MARKET

OF EXPLOSIVES FOR CIVIL USES

UN

NAME and

CLASS/

GLOSSARY (to be used as a guide for

No

DESCRIPTION

DIVISION

information only)

Projectiles, inert with

1.4 G

See Entry for UN No 0424

tracer

Articles, pyrotechnic for

1.1 G

Articles, pyrotechnic for technical

technical purposes

purposes

Articles wh ich 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; r ivets, 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

1.2 G

Projectiles

or 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 i nert, with or without

t r a c e r, o r m a y c o n t a i n a b u r s t e r o r

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

1.4 G

See Entry for UN No 0434

or 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

a n d a p r o p e l l i n g c h a rg e . T h e t e r m

excludes the following articles which

are listed separately: Grenades, practice.

Signals, railway track,

1.3 G

See Entry for UN No 0194

explosive

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,

Group S

NAME and

CLASS/

GLOSSARY (to be used as a guide for

DESCRIPTION

DIVISION

information only)

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.

T hey may be iner t, wit h or wit hout

t r a c e r, o r m a y c o n t a i n a b u r s t e r o r

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;

MAKING AVAILABLE ON THE MARKET

OF EXPLOSIVES FOR CIVIL USES

(d) compatibility of all components as regards their physical and chemical

stability;

(e) the chemical purity of the explosive;

(f)

resistance of the explosive against influence of water where it is

intended to be used in humid or wet conditions and where its safety or

reliability may be adversely affected by water;

(g) resistance to low and high temperatures, where the explosive is intended

to be kept or used at such temperatures and its safety or reliability may

be adversely affected by cooling or heating of a component or of the

explosive as a whole;

(h) the suitability of the explosive for use in hazardous environments (e.g.

firedamp atmospheres, hot masses) if it is intended to be used under

such conditions;

(i)

safety features intended to prevent untimely or inadvertent initiation or

ignition;

(j)

the correct loading and functioning of the explosive when used for its

intended purpose;

(k) suitable instructions and, where necessary, markings in respect of safe

handling, storage, use and disposal;

(l)

the ability of the explosive, its wrapping or other components to

withstand deterioration during storage until the ‘use by’ date specified

by the manufacturer;

(m) specification of all devices and accessories needed for reliable and safe

functioning of the explosive.

2. Each explosive shall be tested under realistic conditions. If this is not

possible in a laboratory, the tests shall be carried out in the conditions in

which the explosive is to be used.

3. Requirements for the groups of explosives

3.1. Blasting explosives shall also comply with the following requirements

(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.

3.2. 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.

3.3. 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.

3.4. 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

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OF EXPLOSIVES FOR CIVIL USES

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

4.1. examine the technical documentation and supporting evidence to assess the

adequacy of the technical design of the explosive.

For the specimen(s)

4.2. verify that the specimen(s) have been manufactured in conformity with the

technical documentation and identify the elements which have been

designed in accordance with the applicable provisions of the relevant

harmonised standards, as well as the elements which have been designed in

accordance with other relevant technical specifications;

4.3. carry out appropriate examinations and tests, or have them carried out, to

check whether, where the manufacturer has chosen to apply the solutions in

the relevant harmonised standards, these have been applied correctly;

4.4. carry out appropriate examinations and tests, or have them carried out, to

check whether, where the solutions in the relevant harmonised standards

have not been applied, the solutions adopted by the manufacturer applying

other relevant technical specifications meet the corresponding essential

safety requirements of these regulations;

4.5. agree with the manufacturer on a location where the examinations and tests

will be carried out.

5. The notified body shall draw up an evaluation report that records the

activities undertaken in accordance with point 4 and their outcomes.

Without prejudice to its obligations vis-à-vis the notifying authorities, the

notified body shall release the content of that report, in full or in part, only

with the agreement of the manufacturer.

6. Where the type meets the requirements of 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.

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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-

t y p e e xa m i n a t i o n c e r t i f i c a t e a n d s a ti s f y t h e r e qu i r e m e n t s o f th e se

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

4.1. The manufacturer shall affix the CE marking to each individual explosive

that is in conformity with the type described in the EU-type examination

certificate and satisfies the applicable requirements of these regulations.

4.2. The manufacturer shall draw up a written EU declaration of conformity for

each explosive type and keep it at the disposal of the national authorities for

10 years after the explosive has been placed on the market. The EU

declaration of conformity shall identify the explosive type for which it has

been drawn up.

A copy of the EU declaration of conformity shall be made available to the

relevant authorities upon request.

5. Authorised representative

The manufacturer’s obligations set out in point 4 may be fulfilled by his

authorised representative, on his behalf and under his responsibility,

provided that they are specified in the mandate.

Module D

Conformity to type based on quality assurance of the production process

1. Conformity to type based on quality assurance of the production process is

the part of a conformity assessment procedure whereby the manufacturer

fulfils the obligations laid down in points 2 and 5, and ensures and declares

on his sole responsibility that the explosives concerned are in conformity

with the type described in the EU-type examination certificate and satisfy

the requirements of 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

3.1. The manufacturer shall lodge an application for assessment of his quality

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

The application shall include

(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.

3.2. The quality system shall ensure that the explosives are in conformity with

the type described in the EU-type examination certificate and comply with

the requirements of these regulations that apply to them.

All the elements, requirements and provisions adopted by the manufacturer

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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.

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

satisfies the requirements referred to in point 3.2.

It shall presume conformity with those requirements in respect of the

elements of the quality system that comply with the corresponding

specifications of the relevant harmonised standard.

In addition to experience in quality management systems, the auditing team

shall have at least one member with experience of evaluation in the relevant

product field and product technology concerned, and knowledge of the

applicable requirements of 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.

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

quality system as approved and to maintain it so that it remains adequate and

efficient.

3.5. The manufacturer shall keep the notified body that has approved the quality

system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide whether

the modified quality system will continue to satisfy the requirements

referred to in point 3.2 or whether a reassessment is necessary.

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

the conclusions of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body

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

fulfils the obligations arising out of the approved quality system.

4.2. The manufacturer shall, for assessment purposes, allow the notified body

access to the manufacture, inspection, testing and storage sites and shall

provide it with all necessary information, in particular

(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.

4.3. The notified body shall carry out periodic audits to make sure that the

manufacturer maintains and applies the quality system and shall provide the

manufacturer with an audit report

4.4. In addition, the notified body may pay unexpected visits to the

manufacturer. During such visits the notified body may, if necessary, carry

out product tests, or have them carried out, in order to verify that the quality

system is functioning correctly. The notified body shall provide the

manufacturer with a visit report and, if tests have been carried out, with a

test report.

5. CE marking and EU declaration of conformity

5.1. The manufacturer shall affix the CE marking, and, under the responsibility

of the notified body referred to in point 3.1, the latter ’s identification

number to each individual explosive that is in conformity with the type

described in the EU-type examination certificate and satisfies the applicable

requirements of 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.

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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

3.1. The manufacturer shall lodge an application for assessment of his quality

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

The application shall include

(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.

3.2. The quality system shall ensure compliance of the explosives with the type

described in the EU-type examination certificate and with the applicable

requirements of 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

w r i t t e n p o l i c i e s , pr o c e d u r e s an d i n s t r u c t i o n s . T h i s q u a l i t y sy s te m

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.

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

satisfies the requirements referred to in point 3.2.

It shall presume conformity with those requirements in respect of the

elements of the quality system that comply with the corresponding

specifications of relevant harmonised standard.

In addition to experience in quality management systems, the auditing team

shall have at least one member with experience of evaluation in the relevant

product field and product technology concerned, and knowledge of the

applicable requirements of 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

o r d e r t o v e r i f y t h e m a n u f a c t u r e r ’s a b i l i t y t o i d e n t i f y t h e r e l e v a n t

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.

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

quality system as approved and to maintain it so that it remains adequate and

efficient.

3.5. The manufacturer shall keep the notified body that has approved the quality

system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide whether

the modified quality system will continue to satisfy the requirements

referred to in point 3.2 or whether a reassessment is necessary.

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

the conclusions of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body

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

fulfils the obligations arising out of the approved quality system.

4.2. The manufacturer shall, for assessment purposes, allow the notified body

access to the manufacture, inspection, testing and storage sites and shall

provide it with all necessary information, in particular

(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.

4.3. The notified body shall carry out periodic audits to make sure that the

manufacturer maintains and applies the quality system and shall provide the

manufacturer with an audit report.

4.4. In addition, the notified body may pay unexpected visits to the

manufacturer.

During such visits the notified body may, if necessary, carry out product

tests, or have them carried out, in order to verify that the quality system is

functioning correctly. The notified body shall provide the manufacturer with

a visit report and, if tests have been carried out, with a test report.

5. CE marking and EU declaration of conformity

5.1. The manufacturer shall affix the CE marking, and, under the responsibility

of the notified body referred to in point 3.1, the latter ’s identification

number to each individual explosive that is in conformity with the type

described in the EU-type examination certificate and satisfies the applicable

requirements of these regulations.

5.2. The manufacturer shall draw up a written EU declaration of conformity for

each explosive type and keep it at the disposal of the national authorities for

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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-

t y p e e xa m i n a t i o n c e r t i f i c a t e a n d s a ti s f y t h e r e qu i r e m e n t s o f th e se

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

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

in the relevant harmonised standard(s) and, or equivalent tests set out in

other relevant technical specifications shall be carried out in order to verify

conformity with the approved type described in the EU-type examination

certificate and with the appropriate requirements of these regulations. In the

absence of such a harmonised standard, the notified body concerned shall

decide on the appropriate tests to be carried out.

4.2. The notified body shall issue a certificate of conformity in respect of the

examinations and tests carried out, and shall affix its identification number

to each approved explosive or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity available for

inspection by the national authorities for 10 years after the explosive has

been placed on the market.

5. Statistical verification of conformity

5.1. The manufacturer shall take all measures necessary so that the

manufacturing process and its monitoring ensure the homogeneity of each

lot produced, and shall present his explosives for verification in the form of

homogeneous lots.

5.2. A random sample shall be taken from each lot. All explosives in a sample

shall be individually examined and appropriate tests set out in the relevant

harmonised standard(s) and, or equivalent tests set out in other relevant

technical specifications, shall be carried out in order to verify their

conformity with the approved type described in the EU-type examination

certificate and with the applicable requirements of 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.

5.3. If a lot is accepted, all explosives of the lot shall be considered approved,

except for those explosives from the sample that have been found not to

satisfy the tests.

The notified body shall issue a certificate of conformity in respect to the

examinations and tests carried out, and shall affix its identification number

to each approved explosive or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity at the disposal of

the national authorities for 10 years after the explosive has been placed on

the market.

5.4. If a lot is rejected, the notified body or the competent authority shall take

appropriate measures to prevent the placing on the market of that lot. In the

event of the frequent rejection of lots the notified body may suspend the

statistical verification and take appropriate measures.

6. CE marking and EU declaration of conformity

6.1. The manufacturer shall affix the CE marking, and, under the responsibility

of the notified body referred to in point 3, the latter’s identification number

to each individual explosive that is in conformity with the approved type

described in the EU-type examination certificate and satisfies the applicable

requirements of these regulations.

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6.2. The manufacturer shall draw up a written EU declaration of conformity for

each explosive type and keep it at the disposal of the national authorities for

10 years after the explosive has been placed on the market. The EU

declaration of conformity shall identify the explosive type for which it has

been drawn up.

A copy of the EU declaration of conformity shall be made available to the

relevant authorities upon request.

If the notified body referred to in point 3 agrees and under its responsibility,

the manufacturer may also affix the notified body’s identification number to

the explosives.

If the notified body agrees and under its responsibility, the manufacturer

may affix the notified body’s identification number to the explosives during

the manufacturing process.

7. Authorised representative

The manufacturer’s obligations may be fulfilled by his authorised

representative, on his behalf and under his responsibility, provided that they

are specified in the mandate. An authorised representative may not fulfil the

manufacturer’s obligations set out in points 2 and 5.1.

Module G

Conformity based on unit verification

1. Conformity based on unit verification is the conformity assessment

procedure whereby the manufacturer fulfils the obligations laid down in

points 2, 3 and 5, and ensures and declares on his sole responsibility that the

explosive concerned, which has been subject to the provisions of point 4, is

in conformity with the requirements of these regulations that apply to it.

2. Technical documentation

2.1. The manufacturer shall establish the technical documentation and make it

available to the notified body referred to in point 4. The documentation shall

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

requirements, and shall include an adequate analysis and assessment of the

risk(s). The technical documentation shall specify the applicable

requirements and cover, as far as relevant for the assessment, the design,

manufacture and operation of the explosive. The technical documentation

shall, wherever applicable, contain at least the following elements

(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)

test reports.

2.2. The manufacturer shall keep the technical documentation at the disposal of

the relevant national authorities for 10 years after the explosive has been

placed on the market.

3. Manufacturing

The manufacturer shall take all measures necessary so that the

manufacturing process and its monitoring ensure conformity of the

m a n u f a c t u r e d ex p lo s i v e w i th t he ap p li c a b l e r e q u ir e m e n t s of t h e se

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

5.1. The manufacturer shall affix the CE marking and, under the responsibility of

the notified body referred to in point 4, the latter’s identification number to

e a c h e x p l o s i v e t h a t s a t i s f i e s t h e a p p l i c a b l e r e q u i r e m e n t s o f t he se

regulations.

5.2. The manufacturer shall draw up a written EU declaration of conformity and

keep it at the disposal of the national authorities for 10 years after the

explosive has been placed on the market. The EU declaration of conformity

shall identify the explosive for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to the

relevant authorities upon request.

6. Authorised representative

The manufacturer’s obligations set out in points 2.2 and 5 may be fulfilled

by his authorised representative, on his behalf and under his responsibility,

provided that they are specified in the mandate.

MAKING AVAILABLE ON THE MARKET

OF EXPLOSIVES FOR CIVIL USES

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

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)

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