MT
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES REGULATIONS
Table of Provisions (26)
Statutory Text (26 Articles)
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES
SUBSIDIARY LEGISLATION 427.70
PLACING ON THE MARKET OF
PYROTECHNIC ARTICLES REGULATIONS
1st July, 2015
LEGAL NOTICE 190 of 2015.
(1) The title of these regulations is the Making Available
on the Market of Pyrotechnic Articles Regulations.
(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 2015.
(2) The making available on the market of pyrotechnic articles
which are in conformity with the Placing on the Market of
Pyrotechnic Articles Regulations, 2010, 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 expiry.
(6) Certificates issued under Directive 2007/23/EC shall be
valid under Directive 2013/29/EU which is being transposed by
these Regulations.
These regulations shall apply to pyrotechnic
articles but shall not apply to
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES
(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
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES
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) (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
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES
on the market.
(1) Pyrotechnic articles falling within the scope of these
regulations shall be placed on the Maltese market only if they
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 these
regulations shall be categorised by the manufacturer according 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
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES
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 market,
manufacturers shall ensure that they have been designed and
manufactured in accordance with the essential safety requirements
set out in Schedule I.
(2)
Manufacturers shall draw up the technical documentation
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES
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,
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES
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 articles
other than pyrotechnic articles for vehicles are labelled visibly,
legibly and indelibly in at least the Maltese or English language.
Such labelling shall be clear, understandable and 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
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES
(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
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES
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 a rticle in a language which c an 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
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES
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
i m p o r t e r t o t h a t e ff e c t a s w e l l a s t h e m a r k e t s u r v e i l l a n c e
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
manufacturer for the purposes of these Regulations and he shall be
subject to the obligations of the manufacturer under regulation 8,
where he places a pyrotechnic article on the market under his name
or 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
following to the Technical Regulations Division and/or the
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
harmonised standards or parts thereof the references of which have
been published in the Official Journal of the European Union shall
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be 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 the
fulfilment of the essential safety requirements set out in Schedule 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
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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
regulations, a conformity assessment body shall meet the
requirements laid down in sub-regulations (2) to (16) and in the
Method for Designating Conformity Assessment Bodies
Regulations.
(2) A conformity assessment body shall be established under
Maltese law of and have legal personality.
(3) A conformity assessment body shall be a third-party body
independent of the organisation or the pyrotechnic article it
(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
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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.
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES
(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.
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES
(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 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.
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES
(1) Notified bodies shall carry out conformity assessments
in accordance with the conformity assessment 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.
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES
(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 collaboration
with the Commissioner of Police, shall take appropriate 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
R e g u l a t i o n s , t h e Te c h n i c a l R e g u l a t i o n s D i v i s i o n s h a l l b e
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 sub-paragraph 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
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES
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
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES
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;
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES
(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 any of
the provisions of these regulations shall be those provided for in
Part IV of the Product Safety Act
Provided that, where it constitutes an offence punishable
w i t h a h i g h e r p u n i s h m e n t u n d e r a n y o t h e r l a w, t h e h i g h e r
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
provisions of these regulations shall be those under the Product
Safety Act and the Ordinance.
(1) Any references to the Placing on the Market of
Pyrotechnic Articles Regulations, 2010 * , shall be 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.
*revoked by these Regulations.
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES
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 used.
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 conditions;
(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 moisture;
(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
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES
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
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 F1 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 F2 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 F3 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 manner.
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.
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.
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES
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.
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
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES
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;
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES
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
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES
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.
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES
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
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,
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES
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,
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES
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.
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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.
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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,
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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
p o s s i b l e t o a s s e s s t h e p y r o t e c h n i c a r t i c l e ’s c o n f o r m i t y w i t h t h e r e l e v a n t
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
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES
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 a n 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
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES
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.
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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
PLACING ON THE MARKET OF PYROTECHNIC ARTICLES
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)
* It is optional for the manufacturer to assign a number to the declaration of conformity.
† L.N. 82 of 2015
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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)