Regulations, 2015

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 19,440, 12 ta’ Ġunju, 2015 B 1521

L.N. 190 of 2015

PRODUCT SAFETY ACT

(CAP. 427)

Making Available on the Market of Pyrotechnic Articles

Regulations, 2015

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

Product Safety Act, the Minister for Social Dialogue, Consumer

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

and Consumer Affairs Authority, has made the following

regulations:-

(1)

The title of these regulations is the Making Title and Scope.

Available on the Market of Pyrotechnic Articles Regulations, 2015.

(2) These regulations transpose Directive 2013/29/EU of the

European Parliament and of the Council of 12 June 2013 on the

harmonisation of the laws of the Member States relating to the

making available on the market of pyrotechnic articles (recast).

(3) These regulations establish rules designed to achieve the

free movement of pyrotechnic articles in the internal market of the

European Union while ensuring a high level of protection of human

health and public security and the protection and safety of consumers

and taking into account the relevant aspects related to environmental

protection.

(4) These regulations also establish the essential safety

requirements which pyrotechnic articles are to fulfil with a view to

their being made available on the market.

(1)

These regulations shall apply as from 1st July Commence-

ment.

2015. (2) The making available on the market of pyrotechnic articles

which are in conformity with the "Placing on the Market of S.L. 427.70

Pyrotechnic Articles Regulations" and which were placed on the

market before 1 July 2015 shall not be impeded.

(3) Maltese national authorisations for fireworks of categories

F1, F2 and F3 granted before 4 July 2010 shall continue to be valid in

Malta until their expiry date or until 4 July 2017, whichever is earlier.

(4) Maltese national authorisations for other pyrotechnic

articles, for fireworks of category F4 and for theatrical pyrotechnic

articles granted before 4 July 2013 shall continue to be valid in Malta

until their expiry date or until 4 July 2017, whichever is earlier.

(5) By way of derogation from sub-regulation (3), national

authorisations for pyrotechnic articles for vehicles, including as spare

parts, granted before 4 July 2013 shall continue to be valid until their

(6) Certificates issued under Directive 2007/23/EC shall be

valid under Directive 2013/29/EU which is being transposed by these

These regulations shall apply to pyrotechnic articles but

shall not apply to

(a)

pyrotechnic articles intended for non-commercial

use by the Armed Forces of Malta, the Malta Police Force or the

Civil Protection Department;

(b)

equipment falling within the scope of the

Conformity Assessment of Marine Equipment Regulations,

transposing Directive 96/98/EC;

(c)

pyrotechnic articles intended for use in the

aerospace industry;

(d)

percussion caps intended specifically for toys

falling within the scope of the Safety of Toys Regulations,

transposing Directive 2009/48/EC;

(e)

explosives falling within the scope of the Civil

Explosives Regulations, transposing Directive 93/15/EEC;

(f)

ammunition as defined under the Arms Act and its

regulations;

(g)

fireworks which are built by a Maltese

manufacturer and let-off in Malta by the licensee of, or by a

license A holder registered with, the same fireworks factory, in

accordance with the provisions of the Ordinance and its

regulations;

In these regulations, unless the context otherwise requires

"accreditation" means accreditation as defined in point 10

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

"ammunition" means projectiles and propelling charges

and blank ammunition used in portable firearms, other guns and

artillery;

"CE marking" means a marking by which the manufacturer

indicates that the pyrotechnic article 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 a pyrotechnic article have been fulfilled;

"distributor" means any natural or legal person in the

supply chain, other than the manufacturer or the importer, who

makes a pyrotechnic article available on the market;

"economic operators" means the manufacturer, the

importer and the distributor;

"firework" means a pyrotechnic article intended for

entertainment purposes;

"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 a pyrotechnic article from a third

country on the Union market;

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

pyrotechnic article for distribution, consumption or use on the

Union market in the course of a commercial activity, whether in

return for payment or free of charge;

"manufacturer" means a natural or legal person who

manufactures a pyrotechnic article, or has such an article

designed or manufactured, and markets that pyrotechnic article

under his name or trademark;

"National Accreditation Board (Malta)" means the

National Accreditation Board (Malta) established in terms of

regulation 3 of the National Accreditation Board (Malta) S.L. 419.07

(Establishment) Regulations;

"notified body" means a body authorised to carry out third-

party conformity assessment tasks under Directive 2013/29/EU

and notified to the European Commission and to the Member

States.

"ordinance" means the Explosives Ordinance;

"person with specialist knowledge" means a person who

holds a valid licence A, B, or C granted in accordance with the

Ordinance and its regulations, or a person who is otherwise

considered by the Commissioner of Police to have specialist

knowledge;

"placing on the market" means the first making available

of a pyrotechnic article on the Union market;

"pyrotechnic article" means any article containing

explosive substances or an explosive mixture of substances

designed to produce heat, light, sound, gas or smoke or a

combination of such effects through self-sustained exothermic

chemical reactions;

"pyrotechnic articles for vehicles" means components of

safety devices in vehicles which contain pyrotechnic substances

used to activate these or other devices;

"recall" means any measure aimed at achieving the return

of a pyrotechnic article that has already been made available to

the end-user;

the "Technical Regulations Division" means the Technical

Regulations Division within the Malta Competition and

Consumer Affairs Authority as established by the Malta

Competition and Consumer Affairs Authority Act;

"technical specification" means a document that prescribes

technical requirements to be fulfilled by a pyrotechnic article;

"theatrical pyrotechnic articles" means pyrotechnic articles

designed for indoor or outdoor stage use, including film and

television productions or similar use;

"Union harmonisation legislation" means any Union

legislation harmonising the conditions for the marketing of

products;

"withdrawal" means any measure aimed at preventing a

pyrotechnic article in the supply chain from being made

available on the market.

(1)

Pyrotechnic articles falling within the scope of Making

these regulations shall be placed on the Maltese market only if they Available

Market.

satisfy the requirements of these regulations.

(2) The placing on the market of pyrotechnic articles which

satisfy the requirements of these regulations shall not be prohibited,

restricted or hindered.

(3) At trade fairs, exhibitions and demonstrations for the

marketing of pyrotechnic articles, the showing and use of pyrotechnic

articles not in conformity with the provisions of these regulations

shall not be prohibited, provided that a visible sign clearly indicates

the name and date of the trade fair, exhibition or demonstration in

question and the non-conformity and non-availability for sale of the

articles until brought into conformity. During such events,

appropriate safety measures shall be taken in accordance with any

requirements laid down by the Commissioner of Police.

(4) The free movement and use of pyrotechnic articles

manufactured for the purpose of research, development and testing

and which are not in conformity with the provisions of these

regulations shall not be prohibited, provided that a visible sign clearly

indicates their non-conformity and non-availability for purposes other

than research, development and testing.

(5) Certificates issued under Directive 2007/23/EC shall be

valid under Directive 2013/29/EU which is being transposed by these

Regulations.

(1)

Pyrotechnic articles falling within the scope of Categorisation

these regulations shall be categorised by the manufacturer according of

Articles.

to their type of use, or their purpose and level of hazard, including

their noise level in accordance with sub-regulation (2). The notified

bodies shall confirm their categorisation as part of the conformity

assessment procedures.

(2) Categorisation shall be as follows

(a)

Fireworks

(i) category F1: fireworks which present a very

low hazard and negligible noise level and which are

intended for use in confined areas, including fireworks

which are intended for use inside domestic buildings;

(ii) category F2: fireworks which present a low

hazard and low noise level and which are intended for

outdoor use in confined areas;

(iii) category F3: fireworks which present a

medium hazard, which are intended for outdoor use in

large open areas and whose noise level is not harmful to

human health;

(iv) category F4: fireworks which present a high

hazard, which are intended for use only by persons with

specialist knowledge (commonly known as fireworks for

professional use) and whose noise level is not harmful to

human health.

(b)

Theatrical pyrotechnic articles

(i) category T1: pyrotechnic articles for stage

use which present a low hazard;

(ii) category T2: pyrotechnic articles for stage

use which are intended for use only by persons with

specialist knowledge.

(c)

Other pyrotechnic articles

(i) category P1: pyrotechnic articles, other than

fireworks and theatrical pyrotechnic articles, which present

a low hazard;

(ii) category P2: pyrotechnic articles, other than

fireworks and theatrical pyrotechnic articles, which are

intended for handling or use only by persons with

specialist knowledge.

(3) The Commissioner of Police shall inform the Technical

Regulations Division of the procedures whereby persons with

specialist knowledge are identified and authorised. The Technical

Regulations Division shall then inform the European Commission of

such procedures.

(1)

Pyrotechnic articles falling within the scope of

these regulations shall not be made available on the market to persons

below the following age limits

(a)

Fireworks

(i)

category F1: 12 years;

(ii) categories F2, F3 and F4: 18 years;

(b)

Theatrical pyrotechnic articles of categories T1 and

T2 and other pyrotechnic articles of categories P1 and P2: 18

years.

(2) Manufacturers, importers and distributors shall not make

available on the market the following pyrotechnic articles except to

persons with specialist knowledge

(a)

fireworks of categories F2, F3 and F4;

(b)

theatrical pyrotechnic articles of categories T1 and

T2 and other pyrotechnic articles of categories P1 and P2.

(3) Other pyrotechnic articles of category P1 for vehicles,

including airbag and seat belt pre-tensioner systems, shall not be

made available to members of the general public unless those

pyrotechnic articles for vehicles have been incorporated in a vehicle

or a detachable vehicle part.

(1)

When placing their pyrotechnic articles on the Obligations of

market, manufacturers shall ensure that they have been designed and the

Manufacturer.

manufactured in accordance with the essential safety requirements set

out in Schedule I.

(2) Manufacturers shall draw up the technical documentation

referred to in Schedule II and have the relevant conformity

assessment procedure referred to in regulation 9 carried out.

Where compliance of a pyrotechnic article 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 pyrotechnic

article 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 pyrotechnic article design or characteristics and changes

in the harmonised standards or in other technical specifications by

reference to which conformity of a pyrotechnic article is declared

shall be adequately taken into account.

When deemed appropriate with regard to the risks

presented by a pyrotechnic article, manufacturers shall, to protect the

health and safety of consumers, upon a duly justified request of the

competent authorities, carry out sample testing of pyrotechnic articles

made available on the market, investigate, and, if necessary, keep a

register of complaints, of non-conforming pyrotechnic articles and

pyrotechnic article recalls, and shall keep distributors informed of any

such monitoring.

(5) Manufacturers shall ensure that pyrotechnic articles which

they have placed on the market are labelled in accordance with

regulation 10 or regulations 11.

(6) Manufacturers shall indicate on the pyrotechnic article

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

pyrotechnic article. 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 English language.

(7) Manufacturers shall ensure that the pyrotechnic article is

accompanied by instructions and safety information in at least the

Maltese or English language. Such instructions and safety

information, as well as any labelling, shall be clear, understandable

and intelligible.

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

a pyrotechnic article which they have placed on the market is not in

conformity with these regulations shall immediately take the

corrective measures necessary to bring that pyrotechnic article into

conformity, to withdraw it or recall it, if appropriate. Furthermore,

where the pyrotechnic article presents a risk, manufacturers shall

immediately inform the competent national authorities of the Member

States in which they made the pyrotechnic article available on the

market to that effect, giving details, in particular, of the non-

compliance and of any corrective measures taken.

(9) Manufacturers shall, further to a reasoned request from

Technical Regulations Division and/or the Commissioner of Police,

provide it with all the information and documentation in paper or

electronic form necessary to demonstrate the conformity of the

pyrotechnic article 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

pyrotechnic articles which they have placed on the market.

(1)

For the assessment of conformity of pyrotechnic

articles the manufacturer shall follow one of the following procedures

referred to in Schedule II

(a)

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

choice of the manufacturer, one of the following procedures

(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);

(b) conformity

based

on

unit

verification

(Module G);

(c) conformity based on full quality assurance

(Module H), insofar as it concerns fireworks of category

F4.

(1)

Manufacturers shall ensure that pyrotechnic Labelling of

articles other than pyrotechnic articles for vehicles are labelled Pyrotechnic

Articles other

visibly, legibly and indelibly in at least the Maltese or English than

Pyrotechnic

language. Such labelling shall be clear, understandable and Articles for

Vehicles.

intelligible.

(2) The labelling of pyrotechnic articles shall include as a

minimum the information about the manufacturer set out in sub-

regulation 8(6) and, where the manufacturer is not established in the

Union, the information about the manufacturer and the importer set

out in sub-regulation 8(6) and sub-regulation 12(3) respectively, the

name and type of the pyrotechnic article, its registration number and

its product, batch or serial number, the minimum age limits set out in

sub-regulation 7(1), the relevant category and instructions for use, the

year of production for category F3 and F4 fireworks and, where

appropriate, a minimum safety distance. The labelling shall include

the net explosive content (NEC).

(3) Fireworks shall also display the following minimum

information

(a)

category F1: where appropriate: "for outdoor use

only" and a minimum safety distance;

(b)

category F2: "for outdoor use only" and, where

appropriate, minimum safety distance(s);

(c)

category F3: "for outdoor use only" and minimum

safety distance(s);

(d)

category F4: "for use only by persons with

specialist knowledge" and minimum safety distance(s).

(4) Theatrical pyrotechnic articles shall also display the

following minimum information

(a)

category T1: where appropriate: "for outdoor use

only" and minimum safety distance(s);

(b)

category T2: "for use only by persons with

specialist knowledge" and minimum safety distance(s).

(5) If the pyrotechnic article does not provide sufficient space

for the labelling requirements referred to in sub-regulations (2), (3)

and (4), the information shall be provided on the smallest piece of

packaging.

(1)

The labelling of pyrotechnic articles for vehicles

shall include the information about the manufacturer set out in sub-

regulation 8(6), the name and type of the pyrotechnic article, its

registration number and its product, batch or serial number and,

where necessary, the safety instructions.

(2) If the pyrotechnic article for vehicles does not provide

sufficient space for the labelling requirements referred to in sub-

regulation (1), the information shall be provided on the packaging.

(3) A safety data sheet for the pyrotechnic article for vehicles,

compiled in accordance with Annex II to Regulation (EC) No 1907/

2006 (REACH) and which takes into account the specific needs of

professional users, shall be supplied to those users in the language

requested by them.

The safety data sheet may be supplied on paper or

electronically, provided that the professional user has the necessary

means of accessing it.

(1)

Importers shall place only compliant pyrotechnic

articles on the market.

(2) Before placing a pyrotechnic article on the market

importers shall ensure that the appropriate conformity assessment

procedure referred to in regulation 9 has been carried out by the

manufacturer. They shall ensure that the manufacturer has drawn up

the technical documentation, that the pyrotechnic article bears the CE

marking and is accompanied by the required documents, and that the

manufacturer has complied with the requirements set out in sub-

regulations 8(5) and (6).

Where an importer considers or has reason to believe that a

pyrotechnic article is not in conformity with the essential safety

requirements set out in Schedule I, he shall not place the pyrotechnic

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

Furthermore, where the pyrotechnic article presents a risk, the

importer shall inform the manufacturer and the market surveillance

authorities to that effect.

(3) Importers shall indicate on the pyrotechnic article 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 pyrotechnic

article. The contact details shall be in at least the Maltese or English

language.

(4) Importers shall ensure that the pyrotechnic article is

accompanied by instructions and safety information in at least the

Maltese or English language.

(5) Importers shall ensure that, while a pyrotechnic article is

under their responsibility, its storage or transport conditions do not

jeopardise its compliance with the essential safety requirements set

out in Schedule I.

(6) When deemed appropriate with regard to the risks

presented by a pyrotechnic article, importers shall, to protect the

health and safety of consumers, upon a duly justified request of the

competent authorities, carry out sample testing of pyrotechnic articles

made available on the market, investigate, and, if necessary, keep a

register of complaints, of non-conforming pyrotechnic articles and

pyrotechnic articles recalls, and shall keep distributors informed of

any such monitoring.

(7) Importers who consider or have reason to believe that a

pyrotechnic article which they have placed on the market is not in

conformity with these Regulations shall immediately take the

corrective measures necessary to bring that pyrotechnic article into

conformity, to withdraw it or recall it, if appropriate. Furthermore,

where the pyrotechnic article presents a risk, importers shall

immediately inform the competent national authorities of the Member

States in which they made the pyrotechnic article available on the

market to that effect, giving details, in particular, of the non-

compliance and of any corrective measures taken.

(8) Importers shall, for 10 years after the pyrotechnic article

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

conformity at the disposal of the market surveillance authorities and

ensure that the technical documentation can be made available to

those authorities, upon request.

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

Technical Regulations Division and/or the Commissioner of Police,

provide them with all the information and documentation in paper or

electronic form necessary to demonstrate the conformity of a

pyrotechnic article in a language which can be easily understood by

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

on any action taken to eliminate the risks posed by pyrotechnic

articles which they have placed on the market.

(1) When making a pyrotechnic article available on the

market distributors shall act with due care in relation to the

requirements of these Regulations.

(2) Before making a pyrotechnic article available on the

market distributors shall verify that the pyrotechnic article bears the

CE marking, that it is accompanied by the required documents, and

by instructions and safety information that are in at least in the

Maltese or English language, and that the manufacturer and the

importer have complied with the requirements set out in sub-

regulations 8(5) and (6) and sub-regulation 12(3) respectively.

Where a distributor considers or has reason to believe that

a pyrotechnic article is not in conformity with the essential safety

requirements set out in Schedule I, he shall not make the pyrotechnic

article available on the market until it has been brought into

conformity. Furthermore, where the pyrotechnic article presents a

risk, the distributor shall inform the manufacturer or the importer to

that effect as well as the market surveillance authorities.

(3) Distributors shall ensure that, while a pyrotechnic article is

under their responsibility, its storage or transport conditions do not

jeopardise its compliance with the essential safety requirements set

out in Schedule I.

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

pyrotechnic article which they have made available on the market is

not in conformity with these Regulations shall make sure that the

corrective measures necessary to bring that pyrotechnic article into

conformity, to withdraw it or recall it, if appropriate, are taken.

Furthermore, where the pyrotechnic article presents a risk,

distributors shall immediately inform the competent national

authorities of the Member States in which they made the pyrotechnic

article 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

Technical Regulations Division and/or the Commissioner of Police,

provide it with all the information and documentation in paper or

electronic form necessary to demonstrate the conformity of a

pyrotechnic article. They shall cooperate with that authority, at its

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

pyrotechnic articles which they have made available on the market.

An importer or distributor shall be considered a Cases in which

manufacturer for the purposes of these Regulations and he shall be Obligations

Manufacturers

subject to the obligations of the manufacturer under regulation 8, apply

Importers and

where he places a pyrotechnic article on the market under his name or Distributors.

trademark or modifies a pyrotechnic article already placed on the

market in such a way that compliance with the requirements of these

Regulations may be affected.

(1)

Economic operators shall, on request, identify the Identification of

following to the Technical Regulations Division and/or the Economic

Operators.

Commissioner of Police

(a)

any economic operator who has supplied them with

a pyrotechnic article;

(b)

any economic operator to whom they have supplied

a pyrotechnic article.

(2) Economic operators shall be able to present the

information referred to in sub-regulation (1) for a period of 10 years

after they have been supplied with the pyrotechnic article and for a

period of 10 years after they have supplied the pyrotechnic article.

Pyrotechnic articles which are in conformity with Presumption of

harmonised standards or parts thereof the references of which have Conformity

Pyrotechnic

been published in the Official Journal of the European Union shall be Articles.

presumed to be in conformity with the essential safety requirements

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

(1)

The EU declaration of conformity shall state that EU Declaration

the fulfilment of the essential safety requirements set out in Schedule of Conformity.

I has been demonstrated.

(2) The EU declaration of conformity shall have the model

structure set out in Schedule III, shall contain the elements specified

in the relevant modules set out in Schedule II and shall be

continuously updated. It shall be translated into the language or

languages required by the Member State in which the pyrotechnic

article is placed or made available on the market. For pyrotechnic

articles made available on the Maltese market, the EU declaration of

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

(3) Where a pyrotechnic article 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

pyrotechnic article with the requirements laid down in these

Regulations.

(1)

The CE marking shall be subject to the general

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

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

indelibly to the pyrotechnic articles. Where that is not possible or not

warranted on account of the nature of the pyrotechnic article, it shall

be affixed to the packaging and to the accompanying documents.

(3) The CE marking shall be affixed before the pyrotechnic

article is placed on the market.

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

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

production control phase. The identification number of the notified

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

the manufacturer.

(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.

(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

regulation 9.

(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 regulation 20.

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

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

Board (Malta).

(4) The Technical Regulations Division shall inform the

European Commission of its procedures for the assessment and

notification of conformity assessment bodies and the monitoring of

notified bodies, and of any changes thereto.

(1)

For the purposes of notification under these Requirements

regulations, a conformity assessment body shall meet the for

Bodies.

requirements laid down in sub-regulations (2) to (16) and in the

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

(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 pyrotechnic article 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 pyrotechnic

articles and/or explosive substances nor the representative of any of

those parties. This shall not preclude the use of pyrotechnic articles

and/or explosive substances that are necessary for the operations of

the conformity assessment body or the use of pyrotechnic articles 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, manufacture or construction, the marketing, installation, use

or maintenance of pyrotechnic articles and/or explosive substances,

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 II 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 pyrotechnic articles 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 I, of the

applicable harmonised standards and of the relevant provisions

of Union harmonisation legislation and of 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 assessment personnel shall be ensured. The

remuneration of the top level management and assessment personnel

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 II 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 these regulations

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 these regulations, 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 regulation 9.

(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 the preceding sub-regulation

shall be accompanied by a description of the conformity assessment

activities, the conformity assessment module or modules and the

pyrotechnic article or articles 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 regulation 20

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 regulation 20 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,

pyrotechnic article or articles concerned and the relevant attestation

of competence.

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

notified body only where no objections are raised by the European

Commission or the other Member States within two weeks of a

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

the purposes of these regulations.

(7) The Technical Regulations Division shall notify the

European Commission and the other Member States of any

subsequent relevant changes to the notification.

(8) Where the Technical Regulations Division has ascertained

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

requirements laid down in regulation 20 or the Method for

Designating Conformity Assessment Bodies Regulations or that it is S.L. 427.45

failing to fulfil its obligations, the Technical Regulations Division

shall restrict, suspend or withdraw notification as appropriate,

depending on the seriousness of the failure to meet those

requirements or fulfil those obligations. It shall immediately inform

the European Commission and the other Member States accordingly.

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

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

Technical Regulations Division shall take appropriate steps to ensure

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

body or kept available to the responsible notifying and market

surveillance authorities, at their request.

(10) The Technical Regulations Division shall provide the

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

the notification or the maintenance of the competence of the body

concerned.

(1)

Notified bodies shall carry out

conformity Operational

assessment Obligations

assessments in accordance with the conformity

Notified Bodies.

procedures provided for in Schedule II.

(2) Conformity assessments shall be carried out in a

proportionate manner, avoiding unnecessary burdens for economic

operators. 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 technology of

the toy 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

toy with these regulations.

(3) Notified bodies carrying out conformity assessments shall

assign registration numbers, identifying pyrotechnic articles which

have been subject to a conformity assessment and their

manufacturers, and shall maintain a register with the registration

numbers of pyrotechnic articles for which they have issued

certificates.

(4) Where a notified body finds that essential safety

requirements set out in Schedule I or corresponding harmonised

standards or other technical specifications have not been met by a

manufacturer, it shall require that manufacturer to take appropriate

corrective measures and shall not issue a certificate of conformity.

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

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

pyrotechnic article no longer complies; it shall require the

manufacturer to take appropriate corrective measures and shall

suspend or withdraw the certificate if necessary.

(6) 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.

(7) 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.

(8) Notified bodies shall provide the other bodies notified

under Directive 2013/29/EU carrying out similar conformity

assessment activities covering the same pyrotechnic articles with

relevant information on issues relating to negative and, on request,

positive conformity assessment results.

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

designated representatives, in the appropriate coordination and

cooperation groups for notified bodies organised by the European

Commission.

(1)

The

Technical

Regulations

Division,

in Market

collaboration with the Commissioner of Police, shall take appropriate Surveillance.

measures to ensure that pyrotechnic articles 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.

In the case of inspections at storage and manufacturing

sites of pyrotechnic articles that are covered by the scope of these

Regulations, the Technical Regulations Division shall be

accompanied by the Police.

(2) Article 15(3) and Articles 16 to 29 of Regulation (EC) No

765/2008 shall apply to pyrotechnic articles.

(3) The Technical Regulations Division shall inform the

European Commission annually about its market surveillance

activities.

(4) Where the Commissioner of Police and/or the Technical

Regulations Division have sufficient reasons to believe that a

pyrotechnic article presents a risk to the health or safety of persons or

to other aspects of public interest protection covered by these

Regulations, they shall carry out an evaluation in relation to the

pyrotechnic article concerned covering all relevant requirements laid

down in these Regulations. The relevant economic operators shall

cooperate as necessary with the Commissioner of Police and/or the

Technical Regulations Division.

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

regulation (4), the Commissioner of Police and/or the Technical

Regulations Division find that the pyrotechnic article 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 actions to bring the pyrotechnic article into

compliance with those requirements, to withdraw the pyrotechnic

article from the market, or to recall it within a reasonable period,

commensurate with the nature of the risk, as they may prescribe. They

shall also inform the notified body accordingly.

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

the measures referred to in the second subparagraph of this paragraph.

(7) Where the Technical Regulations Division, in

collaboration with the Commissioner of Police, 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 they have required the

economic operator to take.

(8) The economic operator shall ensure that all appropriate

corrective action is taken in respect of all the pyrotechnic articles

concerned that it has made available on the market throughout the

European Union.

(9) Where the relevant economic operator does not take

adequate corrective action within the period referred to in sub-

regulation (5), the Technical Regulations Division in collaboration

with the Commissioner of Police shall take all appropriate provisional

measures to prohibit or restrict the pyrotechnic articles being made

available on the Maltese market, to withdraw the pyrotechnic article

from this market or to recall it.

(10) The Technical Regulations Division, upon consultation

with the Commissioner of Police, shall inform the European

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

measures referred to in sub-regulation (9).

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

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

identification of the non-compliant pyrotechnic article, the origin of

the pyrotechnic article, the nature of the non-compliance alleged and

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

taken and the arguments put forward by the relevant economic

operator. In particular, the Technical Regulations Division, in

collaboration with the Commissioner of Police, shall indicate whether

the non-compliance is due to either of the following

(a)

failure of the pyrotechnic article to meet

requirements relating to the health or safety of persons or to

other aspects of public interest protection laid down in these

Regulations; or

(b)

shortcomings in the harmonised standards referred

to in regulation 16 conferring a presumption of conformity.

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

another Member State, the Technical Regulations Division, upon

consultation with the Commissioner of Police, shall without delay

inform the European Commission and the other Member States of any

measures adopted and of any additional information at their disposal

relating to the non-compliance of the pyrotechnic article concerned,

and, in the event of disagreement with the adopted national measure,

of their objections.

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

referred to in the sub-regulation (10), 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 Commissioner of Police, upon

consultation with the Technical Regulations Division, shall ensure

that appropriate restrictive measures, such as withdrawal of the

pyrotechnic article from the market, are taken in respect of the

pyrotechnic article concerned without delay.

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

regulations (8) and (9), objections are raised against the measures

taken by Technical Regulations Division in collaboration with the

Commissioner of Police; the European Commission shall conduct an

evaluation including appropriate consultations with these entities and

the relevant economic operator or operators.

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

considered justified, the Technical Regulations Division in

collaboration with the Commissioner of Police, shall ensure that the

non-compliant pyrotechnic article is withdrawn from the Maltese

market and shall inform the European Commission accordingly.

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

considered unjustified, the national measure shall be withdrawn.

(15) Where, having carried out an evaluation under sub-

regulation (4), the Technical Regulations Division, in collaboration

with the Commissioner of Police, finds that although a pyrotechnic

article is in compliance with these Regulations, it presents a risk to

the health or safety of persons or to other aspects of public interest

protection, it shall require the relevant economic operator to take all

appropriate measures to ensure that the pyrotechnic article concerned,

when placed on the market, no longer presents that risk, to withdraw

the pyrotechnic article from the market or to recall it within a

reasonable period, commensurate with the nature of the risk, as it may

prescribe.

(16) The economic operator shall ensure that corrective action

is taken in respect of all the pyrotechnic articles concerned that he has

made available on the market throughout the European Union.

(17) The Technical Regulations Division, upon consultation

with the Commissioner of Police, shall immediately inform the

European Commission and the other Member States. That

information shall include all available details, in particular the data

necessary for the identification of the pyrotechnic article concerned,

the origin and the supply chain of the pyrotechnic article, the nature

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

measures taken.

(18) Without prejudice to sub-regulations (4) to (13), where the

Technical Regulations Division and/or the Commissioner of Police

make 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 regulation 18;

(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 regulation 18 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 sub-regulation 8(6)

or sub-regulation 12(3) is absent, false or incomplete;

(h)

any other administrative requirement provided for

in regulation 8 or regulation 12 is not fulfilled.

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

(18) persists, the Technical Regulations Division, in collaboration

with the Commissioner of Police, shall take all appropriate measures

to restrict or prohibit the pyrotechnic article being made available on

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

Maltese market.

(20) The powers of the Commissioner of Police under this

regulation may be exercised by any officer or other entity as he may

direct.

(1)

The penalties applicable for the infringement of Penalties.

any of the provisions of these regulations shall be those provided for Cap. 427.

in Part IV of the Product Safety Act

Provided that, where it constitutes an offence punishable

with a higher punishment under any other law, the higher punishment

laid down in that law shall apply.

(2) The necessary measures allowing the detainment of

consignments of pyrotechnic articles that fail to comply with the Cap..33.

provisions of these regulations shall be those under the Product

Safety Act and the Ordinance.

The "Placing on the Market of Pyrotechnic Articles Revokes

Regulations" are being revoked.

(1)

Any references to the revoked regulations shall be Saving.

construed as references to these regulations.

(2) Any references in existing laws, regulations and

administrative provisions to Directive 2007/23/EC shall be construed

as references to Directive 2013/29/EU.

Schedule I

ESSENTIAL SAFETY REQUIREMENTS

1. Each pyrotechnic article must attain the performance

characteristics specified by the manufacturer to the notified body in

order to ensure maximum safety and reliability.

2. Each pyrotechnic article must be designed and

manufactured in such a way that it can be disposed of safely by a

suitable process with minimum effect on the environment.

3. Each pyrotechnic article must function correctly when

used for its intended purpose.

Each pyrotechnic article must be tested under realistic

conditions. If this is not possible in a laboratory, the tests must be

carried out in the conditions in which the pyrotechnic article is to be

The following information and properties - where

applicable - must be considered or tested

(a)

design, construction and characteristic properties,

including detailed chemical composition (mass and percentage

of substances used) and dimensions;

(b)

the physical and chemical stability of the

pyrotechnic article in all normal, foreseeable environmental

(c)

sensitivity to normal, foreseeable handling and

transportation;

(d)

compatibility of all components as regards their

chemical stability;

(e)

resistance of the pyrotechnic article to moisture

where it is intended to be used in humid or wet conditions and

where its safety or reliability may be adversely affected by

(f)

resistance to low and high temperatures, where the

pyrotechnic article 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

pyrotechnic article as a whole;

(g)

safety features intended to prevent untimely or

inadvertent initiation or ignition;

(h)

suitable instructions and, where necessary,

markings in respect of safe handling, storage, use (including

safety distances) and disposal;

(i)

the ability of the pyrotechnic article, its wrapping

or other components to withstand deterioration under normal,

foreseeable storage conditions;

(j)

specification of all devices and accessories needed

and operating instructions for safe functioning of the

pyrotechnic article.

During transportation and normal handling, unless

specified by the manufacturer’s instructions, the pyrotechnic articles

should contain the pyrotechnic composition.

4. Pyrotechnic articles must not contain detonative

explosives other than black powder and flash composition, except for

pyrotechnic articles of categories P1, P2, T2 and fireworks of

category F4 meeting the following conditions

(a)

the detonative explosive cannot be easily extracted

from the pyrotechnic article;

(b)

for category P1, the pyrotechnic article cannot

function in a detonative manner, or cannot, as designed and

manufactured, initiate secondary explosives;

(c)

for categories F4, T2 and P2, the pyrotechnic

article is designed and intended not to function in a detonative

manner, or, if designed to detonate, it cannot as designed and

manufactured initiate secondary explosives.

5. The various groups of pyrotechnic articles must at least

also comply with the following requirements

A.

Fireworks

1. The manufacturer must assign fireworks to different

categories according to Article 6 characterised by net explosive

content, safety distances, noise level, or similar. The category must be

clearly indicated on the label.

(a)

For category

fireworks,

the

following

conditions must be met

(i) the safety distance must be at least 1 m.

However, where appropriate the safety distance may be

less,

(ii) the maximum noise level must not exceed

120 dB (A, imp), or an equivalent noise level as measured

by another appropriate method, at the safety distance,

(iii) category F1 must not comprise bangers,

banger batteries, flash bangers and flash banger batteries,

(iv) throwdowns in category F1 must not contain

more than 2,5mg silver fulminate.

(b)

For category

fireworks,

the

following

conditions must be met

(i) the safety distance must be at least 8 m.

However, where appropriate the safety distance may be

less,

(ii) the maximum noise level must not exceed

120 dB (A, imp), or an equivalent noise level as measured

by another appropriate method, at the safety distance.

(c)

For category

fireworks,

the

following

conditions must be met

(i) the safety distance must be at least 15 m.

However, where appropriate the safety distance may be

less,

(ii) the maximum noise level must not exceed

120 dB (A, imp), or an equivalent noise level as measured

by another appropriate method, at the safety distance.

2. Fireworks may only be constructed of materials which

minimise risk to health, property and the environment from debris.

3. The method of ignition must be clearly visible or must be

indicated by labelling or instructions.

4. Fireworks must not move in an erratic and unforeseeable

5. Fireworks of categories F1, F2 and F3 must be protected

against inadvertent ignition either by a protective cover, by the

packaging, or by the construction of the pyrotechnic article.

Fireworks of category F4 must be protected against inadvertent

ignition by methods specified by the manufacturer.

B.

Other pyrotechnic articles

1. Pyrotechnic articles must be designed in such a way as to

minimise risk to health, property and the environment during normal

use.

2. The method of ignition must be clearly visible or must be

indicated by labelling or instructions.

3. The pyrotechnic article must be designed in such a way as

to minimise risk to health, property and the environment from debris

when initiated inadvertently.

4. Where appropriate, the pyrotechnic article must function

properly until the "use by" date specified by the manufacturer.

C.

Ignition devices

1. Ignition devices must be capable of being reliably initiated

and be of sufficient initiation capability under all normal, foreseeable

conditions of use.

2. Ignition devices must be protected against electrostatic

discharge under normal, foreseeable conditions of storage and use.

3. Electric igniters must be protected against electromagnetic

fields under normal, foreseeable conditions of storage and use.

4. The covering of fuses must be of adequate mechanical

strength and adequately protect the explosive filling when exposed to

normal, foreseeable mechanical stress.

5. The parameters for the burning times of fuses must be

provided with the pyrotechnic article.

6. The electrical characteristics (e.g. no-fire current,

resistance, etc.) of electric igniters must be provided with the

pyrotechnic article.

7. The wires of electric igniters must be sufficiently insulated

and must be of sufficient mechanical strength, including the solidity

of the link to the igniter, taking account of their intended use.

Schedule II

CONFORMITY ASSESSMENT PROCEDURES

MODULE B:EU-type examination

1. EU-type examination is the part of a conformity

assessment procedure in which a notified body examines the technical

design of a pyrotechnic article and verifies and attests that the

technical design of the pyrotechnic article 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 pyrotechnic article

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;

(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 pyrotechnic

article"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

pyrotechnic article. The technical documentation shall contain,

wherever applicable, at least the following elements

(i)

a general description of the pyrotechnic

article;

(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 pyrotechnic article;

(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 case

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 pyrotechnic article

4.1. Examine the technical documentation and supporting

evidence to assess the adequacy of the technical design of the

pyrotechnic article.

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, including those in other relevant technical

specifications applied, 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 pyrotechnic article 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 pyrotechnic articles 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 pyrotechnic article 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 authorities

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 authorities the list of

such certificates and/or any additions thereto refused, suspended or

otherwise restricted.

Each notified body shall inform the other notified bodies

concerning the EU-type examination certificates and/or any additions

thereto which it has refused, withdrawn, suspended or otherwise

restricted, and, upon request, concerning such certificates and/or

additions thereto which it has issued.

The Commission, the Member States and the other notified

bodies may, on request, obtain a copy of the EU-type examination

certificates and/or additions thereto. On request, the European

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 pyrotechnic article has been placed on the market.

MODULE C2: 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 pyrotechnic articles

concerned are in conformity with the type described in the EU-type

examination certificate and satisfy the requirements of these

Regulations that apply to them.

2. Manufacturing

The manufacturer shall take all measures necessary so that the

manufacturing process and its monitoring ensure conformity of the

manufactured pyrotechnic articles 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 the body, in order to verify the quality of the internal

checks on the pyrotechnic article, taking into account, inter alia, the

technological complexity of the pyrotechnic articles 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 pyrotechnic article 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 body shall take appropriate measures.

The acceptance sampling procedure to be applied is intended to

determine whether the manufacturing process of the pyrotechnic

article performs within acceptable limits, with a view to ensuring

conformity of the pyrotechnic article.

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 pyrotechnic article 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 product model and keep it at

the disposal of the national authorities for 10 years after the

pyrotechnic article has been placed on the market. The EU

declaration of conformity shall identify the pyrotechnic article

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.

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

pyrotechnic articles 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 pyrotechnic

articles 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

pyrotechnic articles concerned.

The application shall include

(a)

the name and address of the manufacturer;

(b)

a written declaration that the same application has

not been lodged with any other notified body;

(c)

all relevant information for the pyrotechnic article

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 pyrotechnic

articles are in conformity with the type described in the EU-type

examination certificate and comply with the requirements of these

Regulations that apply to them.

All the elements, requirements and provisions adopted by the

manufacturer shall be documented in a systematic and orderly manner

in the form of written policies, procedures and instructions. The

quality system documentation shall permit a consistent interpretation

of the quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of

(a)

the quality objectives and the organisational

structure, responsibilities and powers of the management with

regard to product quality;

(b)

the corresponding manufacturing, quality control

and quality assurance techniques, processes and systematic

actions that will be used;

(c)

the examinations and tests that will be carried out

before, during and after manufacture, and the frequency with

which they will be carried out;

(d)

the quality records, such as inspection reports and

test data, calibration data, qualification reports on the personnel

concerned, etc.; and

(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 3.1(e) 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 pyrotechnic article 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 pyrotechnic article

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 product model and keep it at the disposal of

the national authorities for 10 years after the pyrotechnic article has

been placed on the market. The EU declaration of conformity shall

identify the pyrotechnic article 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 pyrotechnic article 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 authorities of

quality system approvals issued or withdrawn, and shall, periodically

or upon request, make available to its notifying authorities 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.

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 pyrotechnic

articles 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 pyrotechnic articles

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

pyrotechnic articles concerned.

The application shall include the following information

(a)

the name and address of the manufacturer;

(b)

a written declaration that the same application has

not been lodged with any other notified body;

(c)

all relevant information for the pyrotechnic article

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

pyrotechnic articles with the type described in the EU-type

examination certificate and with the applicable requirements of these

Regulations.

All the elements, requirements and provisions adopted by the

manufacturer shall be documented in a systematic and orderly manner

in the form of written policies, procedures and instructions. 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 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 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 3.1(e), in order to verify

the manufacturer’s ability to identify the relevant requirements of

these Regulations and to carry out the necessary examinations with a

view to ensuring compliance of the pyrotechnic article 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 pyrotechnic article

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 product model and keep it at the disposal of

the national authorities for 10 years after the pyrotechnic article has

been placed on the market. The EU declaration of conformity shall

identify the pyrotechnic article 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 pyrotechnic article 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 authorities of

quality system approvals issued or withdrawn, and shall, periodically

or upon request, make available to its notifying authorities 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.

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 pyrotechnic article concerned,

which has been subject to the provisions of point 4, is in conformity

with the requirements of these Regulations that apply to it.

2. Technical documentation

The manufacturer shall establish the technical documentation

and make it available to the notified body referred to in point 4. The

documentation shall make it possible to assess the pyrotechnic

article’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 pyrotechnic article. The technical documentation

shall, wherever applicable, contain at least the following elements

(a)

a general description of the pyrotechnic article;

(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 pyrotechnic article;

(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.;

(f)

test reports.

The manufacturer shall keep the technical documentation at the

disposal of the relevant national authorities for 10 years after the

pyrotechnic article has been placed on the market.

3. Manufacturing

The manufacturer shall take all measures necessary so that the

manufacturing process and its monitoring ensure conformity of the

manufactured pyrotechnic article with the applicable requirements of

these Regulations.

4. Verification

A notified body chosen by the manufacturer shall carry out

appropriate examinations and tests, set out in the relevant harmonised

standards and/or equivalent tests set out in other relevant technical

specifications, to check the conformity of the pyrotechnic article 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 pyrotechnic article, 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 pyrotechnic

article has been placed on the market.

5. CE marking and EU declaration of conformity

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

the responsibility of the notified body referred to in point 4, the

latter’s identification number to each pyrotechnic article that satisfies

the applicable requirements of these 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 pyrotechnic article has been placed on the market.

The EU declaration of conformity shall identify the pyrotechnic

article 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.

MODULE H: Conformity based on full quality assurance

1. Conformity based on full quality assurance is the

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 pyrotechnic articles concerned

satisfy the requirements of these Regulations that apply to them.

2. Manufacturing

The manufacturer shall operate an approved quality system for

design, manufacture and final product inspection and testing of the

pyrotechnic articles 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

pyrotechnic articles concerned.

The application shall include

(a)

the name and address of the manufacturer;

(b)

the technical documentation for one model of each

pyrotechnic article category intended to be manufactured. The

technical documentation shall, wherever applicable, contain at

least the following elements

-

a general description of the pyrotechnic

article;

-

conceptual design and manufacturing

drawings and schemes of components, sub-assemblies,

circuits, etc.;

-

descriptions and explanations necessary for

the understanding of those drawings and schemes and the

operation of the pyrotechnic article;

-

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;

-

results of design

calculations

made,

examinations carried out, etc.;

-

test reports;

(c)

the documentation concerning the quality system;

(d)

a written declaration that the same application has

not been lodged with any other notified body.

3.2. The quality system shall ensure compliance of the

pyrotechnic articles with the applicable requirements of these

Regulations.

All the elements, requirements and provisions adopted by the

manufacturer shall be documented in a systematic and orderly manner

in the form of written policies, procedures and instructions. That

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 design and product quality;

(b)

the technical design specifications, including

standards that will be applied and, where the relevant

harmonised standards will not be applied in full, the means that

will be used to ensure that the essential safety requirements of

these Regulations will be met;

(c)

the design control and design verification

techniques, processes and systematic actions that will be used

when designing the pyrotechnic articles pertaining to the

pyrotechnic article category covered;

(d)

the corresponding manufacturing, quality control

and quality assurance techniques, processes and systematic

actions that will be used;

(e)

the examinations and tests that will be carried out

before, during and after manufacture, and the frequency with

which they will be carried out;

(f)

the quality records, such as inspection reports and

test data, calibration data, qualification reports on the personnel

concerned, etc.;

(g)

the means of monitoring the achievement of the

required design and 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 experienced as an

assessor 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 3.1(b) to verify the

manufacturer’s ability to identify the applicable requirements of these

Regulations and to carry out the necessary examinations with a view

to ensuring compliance of the pyrotechnic article with those

requirements.

The manufacturer shall be notified of the decision.

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 design, 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 as provided for by the design

part of the quality system such as the results of analyses,

calculations, tests, etc.;

(c)

the quality records as provided for by the

manufacturing part of the quality system 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 check the proper functioning of the quality system. It shall provide

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

with a test report.

4.5. 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 pyrotechnic article

that satisfies the applicable requirements of these Regulations.

5.2. The manufacturer shall draw up a written EU declaration

of conformity for each product model and keep it at the disposal of

the national authorities for 10 years after the pyrotechnic article has

been placed on the market. The EU declaration of conformity shall

identify the pyrotechnic article 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 pyrotechnic article has been placed on the market, keep at the

disposal of the national authorities

(a)

the technical documentation referred to in point

3.1;

(b)

the documentation concerning the quality system

referred to in point 3.1;

(c)

the information relating to the change referred to in

point 3.5, as approved;

(d)

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 authorities of

quality system approvals issued or withdrawn and shall, periodically

or upon request, make available to its notifying authorities 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.

Schedule III

EU DECLARATION OF CONFORMITY (No XXXX) *

1. Registration number issued in accordance with the

"Traceability of Pyrotechnic Articles Regulations" ** .

2. Product, batch or serial number

3. Name and address of the manufacturer

4. This declaration of conformity is issued under the sole

responsibility of the manufacturer.

5. Object of the declaration (identification of product

allowing traceability)

6. The object of the declaration described above is in

conformity with the relevant Union harmonisation legislation

7. References to the relevant harmonised standards used or

references to the other technical specifications in relation to which

conformity is declared

8. The notified body … (name, number) performed …

(description of intervention) and issued the certificate

9. Additional information

-

Signed for and on behalf of

-

(place and date of issue)

-

(name, function) (signature)

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

** L.N. 82 of 2015

B

€2.25